[House Hearing, 114 Congress]
[From the U.S. Government Publishing Office]








    HEARING TO CONSIDER THE IMPACTS OF THE ENVIRONMENTAL PROTECTION 
                                AGENCY'S
                      ACTIONS ON THE RURAL ECONOMY

=======================================================================

                                HEARING

                               BEFORE THE

                        COMMITTEE ON AGRICULTURE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED FOURTEENTH CONGRESS

                             SECOND SESSION

                               __________

                           FEBRUARY 11, 2016

                               __________

                           Serial No. 114-41




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          Printed for the use of the Committee on Agriculture
                         agriculture.house.gov






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                        COMMITTEE ON AGRICULTURE

                  K. MICHAEL CONAWAY, Texas, Chairman

RANDY NEUGEBAUER, Texas,             COLLIN C. PETERSON, Minnesota, 
    Vice Chairman                    Ranking Minority Member
BOB GOODLATTE, Virginia              DAVID SCOTT, Georgia
FRANK D. LUCAS, Oklahoma             JIM COSTA, California
STEVE KING, Iowa                     TIMOTHY J. WALZ, Minnesota
MIKE ROGERS, Alabama                 MARCIA L. FUDGE, Ohio
GLENN THOMPSON, Pennsylvania         JAMES P. McGOVERN, Massachusetts
BOB GIBBS, Ohio                      SUZAN K. DelBENE, Washington
AUSTIN SCOTT, Georgia                FILEMON VELA, Texas
ERIC A. ``RICK'' CRAWFORD, Arkansas  MICHELLE LUJAN GRISHAM, New Mexico
SCOTT DesJARLAIS, Tennessee          ANN M. KUSTER, New Hampshire
CHRISTOPHER P. GIBSON, New York      RICHARD M. NOLAN, Minnesota
VICKY HARTZLER, Missouri             CHERI BUSTOS, Illinois
DAN BENISHEK, Michigan               SEAN PATRICK MALONEY, New York
JEFF DENHAM, California              ANN KIRKPATRICK, Arizona
DOUG LaMALFA, California             PETE AGUILAR, California
RODNEY DAVIS, Illinois               STACEY E. PLASKETT, Virgin Islands
TED S. YOHO, Florida                 ALMA S. ADAMS, North Carolina
JACKIE WALORSKI, Indiana             GWEN GRAHAM, Florida
RICK W. ALLEN, Georgia               BRAD ASHFORD, Nebraska
MIKE BOST, Illinois
DAVID ROUZER, North Carolina
RALPH LEE ABRAHAM, Louisiana
JOHN R. MOOLENAAR, Michigan
DAN NEWHOUSE, Washington
TRENT KELLY, Mississippi

                                 ______

                    Scott C. Graves, Staff Director

                Robert L. Larew, Minority Staff Director

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                             C O N T E N T S

                              ----------                              
                                                                   Page
Conaway, Hon. K. Michael, a Representative in Congress from 
  Texas, opening statement.......................................     1
    Prepared statement...........................................     3
Newhouse, Hon. Dan, a Representative in Congress from Washington, 
  submitted letter...............................................    65
Peterson, Hon. Collin C., a Representative in Congress from 
  Minnesota, opening statement...................................     4

                                Witness

McCarthy, Hon. Gina, Administrator, U.S. Environmental Protection 
  Agency, Washington, D.C........................................     5
    Prepared statement...........................................     7
    Supplementary material.......................................    65
    Submitted questions..........................................    68
 
    HEARING TO CONSIDER THE IMPACTS OF THE ENVIRONMENTAL PROTECTION
                 AGENCY'S ACTIONS ON THE RURAL ECONOMY

                              ----------                              


                      THURSDAY, FEBRUARY 11, 2016

                          House of Representatives,
                                  Committee on Agriculture,
                                                   Washington, D.C.
    The Committee met, pursuant to call, at 10:00 a.m., in Room 
1300 of the Longworth House Office Building, Hon. K. Michael 
Conaway [Chairman of the Committee] presiding.
    Members present: Representatives Conaway, Neugebauer, 
Goodlatte, Lucas, King, Rogers, Thompson, Gibbs, Austin Scott 
of Georgia, Crawford, DesJarlais, Gibson, Hartzler, Benishek, 
Denham, LaMalfa, Davis, Yoho, Walorski, Allen, Bost, Abraham, 
Moolenaar, Newhouse, Kelly, Peterson, David Scott of Georgia, 
Costa, Walz, Fudge, McGovern, DelBene, Lujan Grisham, Kuster, 
Nolan, Maloney, Aguilar, Plaskett, Adams, Graham, and Ashford.
    Staff present: John Goldberg, Josh Maxwell, Patricia 
Straughn, Scott Sitton, Stephanie Addison, Faisal Siddiqui, 
John Konya, Anne Simmons, Evan Jurkovich, Keith Jones, Nicole 
Scott, and Carly Reedholm.

OPENING STATEMENT OF HON. K. MICHAEL CONAWAY, A REPRESENTATIVE 
                     IN CONGRESS FROM TEXAS

    The Chairman. Good morning. This hearing of the Committee 
of Agriculture to consider the impacts of the Environmental 
Protection Agency's actions on the rural economy, will come to 
order. I have asked Mike Bost to open us with a prayer. 
Michael?
    Mr. Bost. If you all would just bow your heads? Dear 
Heavenly Father, we thank you so much for the opportunity to 
serve this great nation. Lord, we thank you for the freedoms 
that we have. We thank you that you have blessed us as you have 
with the rich resources, and the ability to use those to make 
the world a better place. Lord, guide us and direct us. Give us 
wisdom through this hearing. We ask all this in Jesus's name. 
Amen.
    The Chairman. Thank you, Michael. Well, good morning, and I 
want to thank Administrator McCarthy for being here this 
morning. Thank you, ma'am. I appreciate you being here. There 
is a reason a top issue for nearly every Member of our 
Agriculture Committee is related to the regulatory agenda of 
the Environmental Protection Agency. Many Members of this 
Committee believe that over the years the EPA has pursued an 
agenda seemingly absent of any recognition of the consequences 
for rural America and production agriculture. The EPA is 
creating regulations and policies that are burdensome, 
overreaching, and that negatively affect the jobs in the rural 
economy.
    Perhaps the most poignant example is the EPA's recent 
Waters of the U.S. Rule, or, as the EPA likes to call it, the 
Clean Water Rule. I will be frank, this rule is not about clean 
water. Everyone wants and deserves to drink clean water. This 
is not about safe drinking water in Flint, Michigan, which some 
have purposely confused with the WOTUS overreach. Rebranding 
government overreach as a part of a social media campaign does 
not change the content of the rule. This rule is simply the 
result of the EPA ignoring stakeholders, including states and 
other Federal agencies, and the American people, in order to 
egregiously and vastly expand its jurisdiction. This rule is 
already tied up in the court system, and I would imagine it 
will be there for a number of years.
    This is only one of the many instances where I believe the 
Agency has ignored Congressional intent. Instead of simply 
administering the law, EPA challenges Congress to pass 
legislation that gives the Agency more authority. And, if 
Congress doesn't act, the EPA will legislate via regulation, 
directive, memorandum, or in some instances by intimidation. 
This regulate first and ask questions later approach is 
starting to backfire. Just this week the Supreme Court 
intervened in another overreaching regulatory priority of the 
Obama Administration by staying the implementation of the Clean 
Power Plan. I am glad that the courts have intervened; however, 
it should never have come to this. Just because something 
sounds great in theory here in D.C. does not mean that it will 
work or have a beneficial impact on our constituents. More 
times than not those great theories do nothing but increase the 
cost of doing business.
    Farmers and ranchers and foresters all take great pride in 
their stewardship of the land. They are original 
conservationists. When a family's livelihood depends on caring 
for natural resources, there is an undeniable economic 
incentive to adopt practices that enhance long-term viability. 
While it may be popular among some to blame farmers and 
ranchers for any and every environmental concern that crops up, 
I think that you can acknowledge that nobody cares more about 
the environment than those who derive their livelihood from it.
    Rural America's economy is dependent on agriculture. Today, 
Committee Members will talk about examples in which EPA's 
regulatory approach may unjustifiably increase the cost of 
doing business for America's farmers and ranchers. These 
include the recent Waters of the U.S. rule, the proposed 
changes to the ozone standard, and the recently modified 
standards for farmworkers, and many others. Regardless of the 
degree to which somebody believed individual government 
regulations might be justifiable, all regulations must be 
developed in a manner that is based on science, and mindful of 
the economic consequences. For instance, farmers face 
increasing pressure from pests and disease. If existing 
pesticide uses were to be prohibited, the increase in crop 
losses will undoubtedly impact food prices and food security. 
If EPA fails to adequately calculate and/or consider the 
economic consequences of these actions, the consequences could 
be devastating.
    Federal law dictates that the USDA serve as an important 
advisor to EPA in the regulation of pesticides. Historically 
USDA's expertise and advice has been evident in the actions EPA 
has taken to evaluate pesticides and their uses. USDA's 
perspective, and the knowledge of production agriculture, is 
critical, since we know that crop protection products can 
increase farm yields as much as 40 to 70 percent, depending on 
the crop. It concerns me to hear the farm communities express 
increasingly urgent concerns about the lack of seriousness with 
which the EPA takes and incorporates the USDA expertise, 
advice, and opinions, especially during formal inter-agency 
reviews.
    I anticipate that every Member will wish to engage you in a 
discussion of specific areas of concern. My hope is that this 
hearing will serve to open the door to a more cooperative 
working relationship with EPA generally. Farmers and ranchers 
believe the EPA is attacking them. They believe little credit 
is given to them for the voluntary conservation activities that 
they have engaged in for years. This Committee is going to be 
an advocate for our farmers, as you would expect.
    [The prepared statement of Mr. Conaway follows:]

  Prepared Statement of Hon. K. Michael Conaway, a Representative in 
                          Congress from Texas
    Good morning. I thank Administrator McCarthy for being here today.
    There is a reason a top issue for nearly every Member of the 
Agriculture Committee is related to the regulatory agenda of the 
Environmental Protection Agency. Many Members of this Committee believe 
that over the years, EPA has pursued an agenda seemingly absent any 
recognition of the consequences for rural America and production 
agriculture. EPA is creating regulations and policies that are 
burdensome, overreaching, and that negatively affect jobs and the rural 
economy.
    Perhaps the most poignant example is EPA's recent power grab with 
the Waters of the United States rule. Or, as EPA likes to call it--The 
Clean Water Rule. I'll be frank--this rule is not about clean water. 
Everyone wants and deserves clean water. This is not about safe 
drinking water in Flint, Michigan, which some have purposefully 
confused with the WOTUS overreach.
    Rebranding government overreach as part of an illicit social media 
campaign does not change the content of the rule. This rule is simply 
the result of EPA ignoring stakeholders, including states, other 
Federal agencies, and the American people, in order to egregiously and 
vastly expand its jurisdiction. This rule is already tied up in the 
court system, and I would imagine it will be there for many years.
    This is only one of many instances where the Agency has blatantly 
ignored Congressional intent. Instead of simply administering the law, 
EPA challenges Congress to pass legislation that gives the Agency more 
authority; and if Congress doesn't act, EPA will legislate via 
regulation, directive, memorandum, or in some cases by intimidation.
    This regulate first, ask questions later approach is starting to 
backfire on the EPA. Just this week, the Supreme Court intervened in 
another overreaching regulatory priority of the Obama Administration by 
staying the implementation of the so called Clean Power Plan. I am glad 
that the courts have intervened. However, it should never have come to 
this. Just because something sounds good in theory in Washington, D.C., 
does not mean it will work or have a beneficial impact for our 
constituents. More times than not, those great theories do nothing but 
increase the cost of doing business.
    Farmers, ranchers and foresters all take great pride in their 
stewardship of the land. They are the original conservationists. When a 
family's livelihood depends on caring for natural resources, there is 
an undeniable economic incentive to adopt practices that enhance long-
term viability. While it may be popular among some to blame farmers and 
ranchers for any and every environmental concern that crops up, I think 
that you can acknowledge that nobody cares more for the environment 
than those who derive their livelihood from it.
    Rural America's economy is dependent on agriculture. Today, 
Committee Members will talk about examples in which EPA's regulatory 
approach may unjustifiably increase the cost of doing business for 
America's farmers and ranchers. These include the recent WOTUS rule; 
proposed changes to the ozone standard, the recently modified standards 
for farmworkers, and many others.
    Regardless of the degree to which some may believe any individual 
government regulation might be justifiable, all regulations must be 
developed in a manner that is based on science and mindful of the 
economic consequences.
    For instance, farmers face increasing pressures from pests and 
disease. If existing pesticide uses were to be prohibited, the increase 
in crop losses will undoubtedly impact food prices and food security. 
If EPA fails to adequately calculate and/or consider the economic 
consequences of these actions, the consequences could be devastating.
    Federal laws dictate USDA to serve as an important advisor to EPA 
in the regulation of pesticides. Historically, USDA's expertise and 
advice has been evident in the actions EPA has taken to evaluate 
pesticides and their uses. USDA's perspective and knowledge of 
production agriculture is critical since we know that crop protection 
products can increase farm yields as much as 40 percent to even 70 
percent depending on the crop. It concerns me that to hear the farm 
community express increasingly urgent concerns about the lack of 
seriousness with which EPA takes and incorporates USDA expertise, 
advice and opinions, especially during formal interagency review.
    I anticipate that nearly every Member will wish to engage you in a 
discussion of specific areas of concern. It is my hope that this 
hearing will serve to open the door to a more cooperative working 
relationship with EPA generally. I want to end this opening statement 
with this one last observation. Farmers and ranchers believe the EPA is 
attacking them. They believe little credit is given to them for all the 
voluntary conservation activities that they have been engaged in for 
years. This Committee is going to be an advocate for those farmers.
    I thank you again for being here and look forward to a good 
discussion.

    The Chairman. I appreciate the Administrator being here 
this morning, and I will turn to the Ranking Member for any 
questions he may have.

OPENING STATEMENT OF HON. COLLIN C. PETERSON, A REPRESENTATIVE 
                   IN CONGRESS FROM MINNESOTA

    Mr. Peterson. Thank you, Mr. Chairman, and thank you, 
Administrator McCarthy, for joining us. I appreciate you being 
here today. And, we have had our share of disagreements, but 
you have always been willing to listen to my concerns, and we 
don't always get to the same place, but at least you have been 
willing to listen. And I am glad that other Members of the 
Committee will have an opportunity to share what is happening 
in their districts with you today.
    I am on record, along with a lot of others, saying that the 
EPA is an Agency that has overreached on these rules. I simply 
don't believe that there is enough understanding within the 
Agency, or the Administration, about what we do in rural 
America, and the real consequences of new regulations, and what 
they could have on agriculture and the rural economy. The 
proposed Clean Power Plan Rule, which, in my opinion, was 
rightly put on hold by the Supreme Court this week, is one of 
them, as well as the proposed Waters of the U.S. rule, which, 
if I read one more time about the farmer exemptions, I am going 
to tear my hair out, because I have a full time person on my 
staff that does nothing but untangle these water issues under 
the current regime. And the problem is we have four Federal 
agencies deciding what a wetland is, and they don't agree.
    And even within the same Agency you can have somebody in 
one county that will have one opinion versus somebody in the 
next county that has another. I can guarantee you that if this 
rule goes into effect, it is just going to make that worse. We 
have had a Memorandum of Understanding between the NRCS and the 
Corps of Engineers up in our district on our flood mitigation 
that we have been working on, and it just has not worked. We 
still have people all over the map. So I don't have a lot of 
confidence that just putting some exemptions in there is going 
to fix this. I hope there is some other way we can deal with 
that.
    So I hope today's hearing is, as I said, an opportunity to 
get a better grasp on what you are up to, and what we need in 
agriculture and rural communities. I hear concerns from my 
farmers in my districts all the time about this, and I am sure 
other Members do as well. So, again, I thank you for your 
willingness to testify before the Committee today, and I look 
forward to today's hearings and the questions. I yield back.
    The Chairman. I thank the Ranking Member, and I also want 
to thank the Administrator this morning, and welcome her to the 
witness table. I suspect that she understood there would be 
some differences of opinion, and we hope to be respectful with 
that. And, with that, I will introduce the Honorable Gina 
McCarthy, the Administrator for the U.S. Environmental 
Protection Agency in Washington, D.C. And, ma'am, we are ready 
to go whenever you are. And, again, thank you for being here.

     STATEMENT OF HON. GINA McCARTHY, ADMINISTRATOR, U.S. 
       ENVIRONMENTAL PROTECTION AGENCY, WASHINGTON, D.C.

    Ms. McCarthy. Thank you, and good morning, Chairman 
Conaway, Ranking Member Peterson, as well as Members of the 
Committee. I really want to thank you for the honor and 
opportunity to be here with you this morning.
    As stewards of the land, the EPA and farmers share a common 
goal in protecting our environment. As lifelong 
conservationists, farmers', ranchers', and foresters' 
livelihoods depend on healthy land, clean air and water to 
produce the food, fuel, and fiber that we rely on. In the 45 
years since the EPA's founding we have cleaned up 70 percent of 
our nation's air pollution, and hundreds of thousands of miles 
of waterways, all while the economy has tripled. Agriculture 
advanced too, achieving better yields with less water, lower 
risk pesticides, and less fertilizer. I would like to highlight 
some of the EPA initiatives furthering our common goals.
    Working with USDA, and partnering with the pork and dairy 
producers and technical experts, we recently launched an 
initiative promoting recycling nutrients from livestock waste. 
Annually livestock producers manage more than 1 billion tons of 
manure, but that contains valuable nitrogen and phosphorus, 
which, if we harness as a renewable fertilizer, can minimize 
water pollution and build healthy soils. Participants will be 
challenged to use the power of competition to turn innovative 
concepts into designs, and ultimately into working 
technologies, creating the solutions that are a win for 
farmers, the environment, as well as our economy.
    The EPA also partners with USDA with the Local Foods, Local 
Places Project, promoting walkable, healthy, and economically 
vibrant neighborhoods through farmers' markets, co-ops, 
community gardens, and other local food enterprises. By 
focusing development in existing neighborhoods, we help support 
farm economies and protect undeveloped rural lands. Last month 
we announced 27 new communities, raising the total number of 
communities served to 62 in 29 states, just since the program 
started in 2013.
    The Clean Water Rule, which we finalized last year, 
protects the streams and wetlands that one in three Americans 
rely on for drinking water, and farmers and ranchers also need 
for their crops and livestock. As Members of this Committee 
know, recent Supreme Court rulings created uncertainty 
regarding the application of the Clean Water Act to streams and 
wetlands. In developing the rule, the EPA and the Army Corps of 
Engineers responded to requests to define the scope of the 
Clean Water Act more clearly, more predictably, and more 
fairly. In doing so, the Clean Water Rule not only maintains 
current statutory exemptions, it expands regulatory exclusions 
from the definitions of waters of the United States to make it 
clear that the rule does not add any additional permitting 
requirements on farmers and ranchers, and promotes their 
voluntary efforts to protect and enhance clean water. We 
continue outreach to the agriculture community, responding to 
their concerns, answering their questions, and reinforcing the 
fact that all existing agriculture exemptions and exclusions 
continue to apply under the Clean Water Rule.
    Last year the EPA finalized volume standards for the 
Renewable Fuel Standard Program for calendar years 2014, 2015, 
2016, and a volume requirement for biomass-based diesel for 
2017. The final requirements boost renewable fuel production 
and provide for robust, achievable growth of the biofuels 
industry. Overall, this final rule requires that total 
renewable standards grow by more than 1.8 billion gallons from 
2014 to 2016, requiring 11 percent more biofuel production than 
the market produced in 2014. Our 2016 advanced fuel standard is 
nearly 1 billion gallons, or 35 percent, higher than 2014 
actual volumes. The biomass-based diesel standards increases 
every year, to reach 2 billion gallons by 2017. That is a 23 
percent increase over 2014 actual volumes.
    The EPA took steps to improve the administration of the RFS 
Program, and continues to approve new agricultural feedstocks, 
increasing the number of pathways that biofuel producers may 
use to qualify their biofuel under the program. We improved the 
quality, transparency, and efficiency of our petition review 
process for new biofuel pathways, and conducted lifecycle 
analysis on several new feedstocks. The EPA remains committed 
to the Renewable Fuel Program, and meeting Congress's intent to 
responsibly grow renewable fuels over time.
    I recently announced increased protections for the nation's 
two million agricultural workers and their families. Every year 
thousands of preventable pesticide exposure incidents cause 
sick days, lost wages, and medical bills. We can do better. The 
EPA's update reflects extensive stakeholder involvement from 
the agriculture community, industry, and Federal and state 
partners. These provisions will help ensure that farmworkers 
nationwide receive annual safety training, prohibit children 
from handling agricultural pesticides, and provide workers with 
the tools needed to protect themselves and their families from 
pesticide exposures.
    Again, thank you. I am happy and I am honored to be here to 
answer your questions.
    [The prepared statement of Ms. McCarthy follows:]

     Prepared Statement of Hon. Gina McCarthy, Administrator, U.S. 
           Environmental Protection Agency, Washington, D.C.
    Good morning, Chairman Conaway, Ranking Member Peterson, and 
Members of the Committee. Thank you for the opportunity to discuss the 
EPA and agriculture.
    As stewards of the land, the EPA and farmers share a common goal in 
protecting our environment. Inherent conservationists, farmers' 
livelihoods depend on healthy land and clean air and water to produce 
the food, fuel and fiber we rely on. In the 45 years since the EPA's 
founding, we've cleaned up 70 percent of our nation's air pollution and 
hundreds of thousands of miles of waterways, and meanwhile our economy 
has tripled. Agriculture advanced too--achieving better yields with 
less water, lower risk pesticides, and less fertilizer. I would like to 
highlight some of the EPA initiatives furthering our common goals.
Nutrient Recycling Challenge
    Working with USDA, and partnering with pork and dairy producers and 
technical experts, we recently launched an initiative promoting 
recycling nutrients from livestock waste. Annually, livestock producers 
manage more than 1 billion tons of manure containing valuable nitrogen 
and phosphorus, a resource as a renewable fertilizer, and used 
properly, can minimize water pollution and build healthy soils. 
Challenge participants will harness the power of competition, turning 
innovative concepts into designs, and ultimately working technologies, 
creating solutions that are a win for farmers, the environment and the 
economy.
Local Foods, Local Places
    The EPA also partners with USDA in the ``Local Foods, Local 
Places'' project, promoting walkable, healthy, and economically vibrant 
neighborhoods through farmers' markets, co-ops, community gardens, and 
other local food enterprises. Focusing development in existing 
neighborhoods helps support farm economies and protect undeveloped 
rural lands. Last month we announced 27 new communities, serving 62 
communities in 29 states since starting in 2013.
Clean Water Rule
    The Clean Water Rule protects the streams and wetlands that one in 
three Americans rely on for drinking water, and farmers and ranchers 
need for their crops and livestock. As Members of this Committee know, 
recent Supreme Court rulings created uncertainty regarding the 
application of the Clean Water Act to streams and wetlands. In 
developing the rule, the EPA and the U.S. Army responded to requests to 
define the scope of the Clean Water Act more clearly, predictably and 
fairly. In doing so, the Clean Water Rule not only maintains current 
statutory exemptions, it expands regulatory exclusions from the 
definition of waters of the United States to make it clear that the 
rule does not add any additional permitting requirements on farmers and 
ranchers and promotes their voluntary efforts to protect and enhance 
clean water. We continue outreach to the agriculture community, 
responding to their concerns, answering questions, and ensuring that 
all existing agriculture exemptions and exclusions continue to apply.
Renewable Fuel Standard
    Last year, the EPA finalized volume standards for the RFS program 
for calendar years 2014, 2015, and 2016 and a volume requirement for 
biomass-based diesel for 2017. The final requirements boost renewable 
fuel production and provide for robust, achievable growth of the 
biofuels industry.
    Overall, this final rule requires that total renewable standards 
grow by more than 1.8 billion gallons from 2014 to 2016, requiring 11 
percent more biofuel production than the market produced in 2014. Our 
2016 advanced biofuel standard is nearly 1 billion gallons, or 35 
percent higher than 2014 actual volumes. The biomass-based diesel 
standards increases every year to reach 2 billion gallons by 2017, a 23 
percent increase over 2014 actual volumes.
    The EPA took steps to improve the administration of the RFS program 
and continues to approve new agricultural feedstocks, increasing the 
number of pathways that biofuel producers may use to qualify their 
biofuel under the program. We improved the quality, transparency, and 
efficiency of our petition review process for new biofuel pathways, 
clarified qualifying biofuels, and conducted lifecycle analyses on 
several new feedstocks. The EPA remains committed to the RFS program 
and meeting Congress's intent to responsibly grow renewable fuels over 
time.
Agricultural Worker Protection Standards
    I recently announced increased protections for the nation's two 
million agricultural workers and their families. Every year, thousands 
of preventable pesticide exposure incidents cause sick days, lost wages 
and medical bills. Changes to the agricultural worker protection 
standard reduce the risk of injury or illness resulting from contact 
with pesticides while on the job.
    The EPA's updates reflect extensive stakeholder involvement from 
the agricultural community, industry, and Federal and state partners. 
These provisions help ensure farmworkers nationwide receive annual 
safety training, prohibit children from handling agricultural 
pesticides, and provide workers with the tools needed to protect 
themselves and their families from pesticide exposure.
Conclusion
    Thank you and I am happy to answer your questions.

    The Chairman. Well, thank you, ma'am. The chair would 
remind Members that they will be recognized for questioning in 
the order of seniority for Members who were here at the start 
of the hearing. After that, Members will be recognized in the 
order of arrival, and I appreciate Members' understanding. So, 
with that, I recognize myself for 5 minutes.
    Again, thank you for being here. With the 6th Circuit's 
ruling on the Clean Water Plan, difficult to say for those of 
us from west Texas, the legitimate concern that, given that 
both of those involve what we believe is an overreach by the 
Agency, going around Congressional intent, going around the 
law, can you talk to us about efforts that your Agency will 
make on the intervening 11 or so months that you will be there 
to obey the Supreme Court and the 6th Circuit? Will you commit 
to not trying to go around the courts with other ways to get at 
what you are trying to get done?
    Ms. McCarthy. Mr. Chairman, EPA is actually trying to do 
what Congress told us to do with the authorities we have, and 
we feel confident that both of those rules will be seen as an 
appropriate, and proper, and necessary application of the law. 
If you look at the Clean Water rule, the reason we did it was 
to try to clarify confusion that the Supreme Court actually 
raised and created in a couple of their decisions since the 
beginning of the last decade.
    On the Clean Power Plan, it is a pause in terms of the 
implementation and enforcement of the Clean Power Plan, but the 
rule is still in effect, and it will add some time to resolve 
those issues through the courts, but we feel very confident 
that it is going to be borne out to be a legal, lawful, and 
necessary law.
    The Chairman. Right. It is not unexpected for you to take 
that position.
    Ms. McCarthy. Well, thank you for listening.
    The Chairman. It shouldn't be unexpected.
    Ms. McCarthy. I appreciate it.
    The Chairman. We have 31 lawsuits, Attorneys General across 
the country, farmers and ranchers, those who tried to look at 
it, disagree. What I asked, though, was what will you do now, 
while those rules, or regulations, are stayed from 
implementation? Do we need to restrict your funding in the 
appropriations bill to say no monies will be spent on back door 
implementation of either the Clean Water Plan or the Clean 
Power Plan?
    Ms. McCarthy. Actually, what we are trying to do, sir, is 
make sure that the guidance that is currently in place in the 
Clean Water Rule that was issued in 2008 is implemented as well 
as we can. We are certainly going to respect the decisions of 
the court. But, as we have heard, there is a lot of confusion. 
There are a lot of differences in those decisions, so we are 
working with the Army Corps of Engineers to make sure that we 
are implementing what is currently in place as best we can, try 
to avoid some of those confusions, while we hope to bring 
additional clarity when the Clean Water Rule makes its way 
through the courts.
    On the Clean Power Plan, we will still continue to work 
with states that, on a voluntary basis, want to move forward 
with us, and we will continue to provide tools and outreach. 
But we clearly understand that the courts will be winding 
through the process of looking at that rule. The issue 
yesterday meant it is going to take a little longer for that to 
happen. We will respect that, but, in the meantime, we are 
going to continue to address greenhouse gases with the 
authorities under the Clean Air Act that are available to us 
today.
    The Chairman. Okay. Clearly there is a pretty sizable 
difference of agreement that the authorities that you used to 
issue those rules were an overreach, and so I am a little 
troubled by that. Can you talk to us about the input that you 
take from USDA with respect to pesticides, and the work that 
you are doing there? Are you ignoring USDA? I will give you a 
softball, because I suspect you will say no, but can you help 
us understand that you do, in fact, value the expertise and the 
longstanding trust that farmers and ranchers have with USDA in 
this arena, and the distrust that has been created with the EPA 
over the other things that are going on? You can't just 
separate the issues in a vacuum. They are not siloed up. Our 
farmers and ranchers feel under attack. So talk to us about 
your respect for the USDA, and their opinions on pesticides.
    Ms. McCarthy. Well, sir, I work very closely with Secretary 
Vilsack, and my staff work very closely with USDA. We have 
great respect for that Agency, the scientific expertise they 
bring, and their full knowledge of the agriculture community. 
There are laws that require us, even before we propose rules, 
to consult with USDA, and we do that. And then we work very 
closely with them in the inter-agency process to resolve 
differences. So we have a close collaborative relationship. At 
times we may disagree, but it is usually about what the law 
requires us to do, and there is good discussion, and we always 
try to understand the science together, and make the 
appropriate decisions.
    The Chairman. All right. Thank you, ma'am. I yield back. 
The Ranking Member, 5 minutes.
    Mr. Peterson. Thank you, Mr. Chairman. I want to focus on 
this Clean Power Plan a little bit too. So we are kind of 
caught between a situation up in my district. The rural 
electrics get their power from North Dakota, but, obviously we 
are in Minnesota. Well, Minnesota is apparently working with 
you guys on whatever you are up to, and North Dakota is one of 
those that sued you.
    So when you say you are going to work with states, does 
that mean you are going to work with Minnesota, and continue to 
develop a plan with Minnesota while this is going on?
    Ms. McCarthy. Well, we will continue to work with them on a 
voluntary basis, but nothing will be implemented while the stay 
is in place. So if Minnesota wants help and tools, we would 
always work with every state that does that. But in terms of 
actual enforcement of anything, it is clearly on hold until it 
resolves itself through the courts.
    Mr. Peterson. Well, one of our concerns is there was, 
apparently, a 2014 proposal, and then it was finalized, and in 
North Dakota you went from 11 percent to 45 percent emissions 
reductions, the biggest increase of any state. Well, our rural 
cooperative out there in North Dakota, they did some updates to 
their plants, back in 2005 or something, 2004, and put $426 
million in improvements in their firewalls and so forth, and 
then the EPA determined that that was a major overhaul, or 
whatever it was. So you forced them go under some new program 
to put in scrubbers, and a whole bunch of other stuff. They 
sued you. The end result of that was they spent $426 million. 
And my real question is: what that did is it dropped the equity 
in that co-op from 24 percent down to 12 percent. Are you aware 
of that?
    Ms. McCarthy. Not the specific instance in which you are 
referring, sir.
    Mr. Peterson. And so they had signed an agreement with the 
RE West to get financing for this $426 million that you forced 
them to do. And it says that they can't go below a ten percent 
equity in that co-op. Well, they are down to 12 percent now. 
And if this is implemented, they will be down to five percent. 
So they are going to be in violation of the situation with the 
EPA. Are you aware of that?
    Ms. McCarthy. Well, sir, if you are referring to the 
application of the Clean Power Plan? Is that what we are 
talking about there? I know that you were referring to some of 
the regional case decisions.
    Mr. Peterson. They borrowed money to comply with your other 
situation. And in order to get that money they had to agree not 
to go below ten percent.
    Ms. McCarthy. Right.
    Mr. Peterson. So now, if you implement what the Clean Power 
Plan says, you are going to force them way below ten percent. 
They don't have the money to do this anymore. You have already 
taken all their money, and there is no other way in Minnesota--
they won't let them build a power plant, so the only thing we 
can do is get electricity from Canada, if you go ahead and 
complete this? So we are kind of stuck in this whole thing.
    I was going to ask you today to delay this to give us maybe 
10 years to try to comply with this so we don't go bankrupt. 
But now, with this stay, and I don't know where we are at 
anymore, but, I mean, somehow or another we need more time to--
--
    Ms. McCarthy. Well, sir, we are more than happy to work 
with the state, and, in fact, we have been out there. One of 
the things we did was extensive outreach on this, and there was 
concern in some states about whether or not they would 
internally, in that state, be able to make things work. We 
added huge amounts of flexibility in this, and we also engaged 
USDA, the Rural Utilities Service, to work with us and with the 
rural co-ops. We understand that they have unique challenges, 
and we are not going to leave them behind. They deal with some 
of the poorest communities, that cannot afford to have energy 
increases.
    Mr. Peterson. That is exactly correct.
    Ms. McCarthy. And so there are a number of programs that we 
are bringing to bear, as well as flexibilities that will not 
require every facility to make investments.
    Mr. Peterson. Well, for whatever reason, they seem to think 
that you are not going to have flexibility, and not listen to 
them. I don't know why. And some of this power from these 
plants goes to North Dakota, but the majority goes to 
Minnesota, and we are kind of stuck in this whole thing. And, I 
am glad to hear that you are willing to work with them, but 
that is not what they have heard. After they spent that $426 
million, then you went after them on Hayes, and we were able to 
get that stopped. That would have been another thing that would 
have bankrupted them. So they just feel like they are in the 
middle of a whole deal, and they are not listened to, so if 
you----
    Ms. McCarthy. Well, I am happy to personally engage as 
well. I have been meeting with the rural electric----
    Mr. Peterson. I will send them over to your office, and you 
can deal with them.
    Ms. McCarthy.--co-ops, so--okay, sir.
    Mr. Peterson. All right. Thank you.
    The Chairman. The gentleman yields back. Mr. King, 5 
minutes.
    Mr. King. Thank you, Mr. Chairman. Ms. McCarthy, I am over 
here, and I appreciate your testimony, and your service here, a 
good number of things pop up in our minds that--or come to our 
attention. I am just looking at a few headlines here, 6th 
Circuit Puts Controversial Waters of the United States, the 
WOTUS Rule, On Hold. There is another article that addresses 
the Clean Air Act, on hold. And as I am watching this, it seems 
as though the Agency has been pushing back against, especially 
our farmer producers, and our people that care about and value 
their productive real estate.
    I just had a couple of phrases here that I have seen emerge 
from the EPA over the years, and I wanted to start with this: 
water is hydrologically connected to.
    You are familiar with that phrase, and you are also 
familiar with the phrase significant nexus.
    Ms. McCarthy. Yes.
    Mr. King. Now, would you have a judgment on which one of 
those is the most ambiguous?
    Ms. McCarthy. Well, the Clean Water Rule actually tries to 
provide clarity to both of those. The ambiguity arose when the 
Supreme Court actually raised these issues and suggested that 
EPA needed to resolve these. That is what the Clean Water Rule 
is all about.
    Mr. King. And, of course, I am about clarity, of course, 
too.
    Ms. McCarthy. Me too.
    Mr. King. So with regard to clarity, with the Renewable 
Fuel Standard, you have taken a position in past years, back in 
about 2012 or 2013, that we had short grain supplies, and high 
grain prices, therefore you rolled back the directive on the 
RFS. And I will just focus particularly on corn-based ethanol 
for simplicity's sake here. And made that judgment 
administratively, even though the statute required that those 
gallons be more. I notice now that we have a high volume, over-
supply of grain, and low prices that have dropped a little more 
than \1/2\ since that period of time, and I don't notice that 
the same logic is applied when it comes time to adjust the RFS 
for current conditions.
    So if it was a good idea to lower the RFS requirement for 
corn-based ethanol back when grain supplies were short and 
prices were high, why wouldn't it also be a good idea to raise 
it, at least up to the statutory standard, when grain prices 
are low and supplies are high?
    Ms. McCarthy. So the Renewable Fuel Standard that we came 
out with provide us an opportunity to get back on track, as 
well as provide steady growth. The numbers that you are looking 
at in here is our assessment of what we can achieve attempting 
full bore to get to the statutory levels, but recognizing that 
leaps like this, in this short a timeframe, is not possible. So 
we want to achieve those statutory levels, we understand that 
is what Congress intended, but there is a growth that we need 
to recognize, and factors that impact that that we have to take 
into consideration.
    Mr. King. You are talking about production and capacity? 
You are talking about----
    Ms. McCarthy. No, I am not talking about production 
capacity.
    Mr. King. Then what are you addressing?
    Ms. McCarthy. I am addressing the ability for us to be able 
to get that fuel into the system.
    Mr. King. And that is the blend wall?
    Ms. McCarthy. That is correct.
    Mr. King. And do you believe you have the administrative 
authority to abolish the blend wall?
    Ms. McCarthy. Well, these numbers actually push through the 
blend wall, because we understand that we need to do that to 
continue investments in infrastructure----
    Mr. King. And that is answer is yes----
    Ms. McCarthy.--that will be necessary to get to----
    Mr. King. Do you believe you have the administrative 
authority to do that, to abolish the blend wall?
    Ms. McCarthy. I believe we are doing everything that the 
law says, which is to get to these levels as quickly as 
possible, but you have to think of factors like how reasonable 
it is to achieve these within this certain period.
    Mr. King. What about going to E15?
    Ms. McCarthy. Yes.
    Mr. King. Do you have the authority to do that?
    Ms. McCarthy. We actually approved E15 in use of specific 
vehicles----
    Mr. King. Year round?
    Ms. McCarthy.--mostly the modern vehicles.
    Mr. King. Year round?
    Ms. McCarthy. Yes.
    Mr. King. So we are past the E15 blend wall year round? 
There is no vapor pressure requirement that restricts it----
    Ms. McCarthy. There is a vapor pressure requirement. Yes, 
there is, but we approve the use in the vehicles, and it can be 
used. There are certain places where----
    Mr. King. Okay. I am addressing practically speaking. I 
think I should have prefaced my question with that. Then, also, 
with regard to the testing of fuels, my information is that EPA 
relied on a Chevron consultant to design the test fuels. Are 
you familiar with that?
    Ms. McCarthy. No, sir.
    Mr. King. Okay. I am going to pose some of these questions 
to you in a written form so you have an opportunity to digest 
them, and to answer them in a way that is not a high test area 
in the hearing here. I have a stack of questions I would ask 
that you respond to with regard to testing requirements, and 
compliance with the RFS. I would ask you one final question. If 
you were the Administrator of the EPA at the time that the RFS 
expires, sunsets, would you believe that you have the 
administrative authority to extend it beyond its sunset?
    Ms. McCarthy. I am not aware that the RFS sunsets, sir. 
What are we referring to?
    Mr. King. Well, I will put that in my question to you too, 
the specific language that is in the statute.
    Ms. McCarthy. Okay.
    Mr. King. And so that will all come to you, and we will 
look forward to working with you.
    Ms. McCarthy. I will too as well.
    Mr. King. Thank you----
    Ms. McCarthy. Thank you, sir.
    Mr. King.--very much, and I yield back.
    The Chairman. The gentleman yields back. Mr. Costa, 5 
minutes.
    Mr. Costa. Thank you very much, Mr. Chairman. And I want to 
thank the Administrator for being here this morning, and your 
efforts to help us solve problems. I want to continue the 
conversation for a moment on the Renewable Fuel Standard. 
Obviously there is a diversity of opinion as it relates to this 
Committee, and Members of the Congress, on how it is applied 
and implemented. But can you explain the process that the EPA 
will be taking to ensure that the 2017 rules are not delayed 
the way the 2014 rules were?
    Ms. McCarthy. I can, sir. One of the things we made sure 
was to already propose a 2017 standard for biodiesel so that we 
could make sure to keep on track. And we have every interest, 
now that we are on track, to stay that way.
    Mr. Costa. For those of us who believe in alternative fuels 
and renewable fuels, but think that cellulosic fuels are really 
the next generation of this development, can you explain the 
update in the Inspector General's investigation regarding 
climate impacts on the Renewable Fuel Standard as to using food 
to produce fuel is the most effective way to do that, and 
whether that doesn't, in fact, create more pollution issues?
    Ms. McCarthy. Well, I know that there have been a number of 
looks at this issue and investigations, but my job, as EPA 
Administrator, is to implement the law that has been given to 
me. And----
    Mr. Costa. Which you said is probably the most difficult 
law you have to implement?
    Ms. McCarthy. It is a very difficult statute, yes. But it 
is very clear that cellulosic fuels have not progressed 
anywhere near what Congress anticipated, which is one of the 
reasons why those statutory levels are so difficult to meet.
    Mr. Costa. Well, I want to move on to some local issues. As 
you know, California is a very diversified state as it relates 
to its agricultural production. The Environmental Protection 
Agency recently issued a statement on a risk report indicating 
that citrus and cotton honey contained higher levels of 
neonicotinoids than other honey, which would be a risk to 
pollinators. Now, because of the diversification of our crops, 
clearly we are sensitive. We grow a lot of almonds in 
California. I think we gave you some. I am an almond grower 
myself. It does require bees, and we are sensitive to the 
pollination issues, and therefore the impacts of bee deaths and 
colony collapses, but why single out two commodities that don't 
require bees, at least in my state, that, in fact, we go out of 
our way to accommodate bees because a lot of the proximity of 
these crops are nearby each other? And, in fact, recent reports 
have indicated that colonies have propagated, and they are at 
higher levels now than the decline we experienced a few years 
ago.
    Ms. McCarthy. Well, Congressman, we have been to your area 
of the country before together, and I understand how hard the 
almond growers actually work, not just to address the pesticide 
issues, but certainly to conserve water, and I appreciate very 
much all that work. We are happy to work more closely with you 
on neonicotinoids. The science is difficult, but it is growing, 
and it is getting more robust. We think we are following the 
science in our decisions, and if there are issues----
    Mr. Costa. Okay, but we are going to need----
    Ms. McCarthy.--that we need to resolve----
    Mr. Costa.--more of your focus----
    Ms. McCarthy.--we will be happy to do that.
    Mr. Costa.--on this. The Chairman and I last night were in 
a conversation with some orange growers who are dealing with 
citrus greening, and they really think that they are being 
singled out, because of the way in which the Environmental 
Protection Agency has approached this. And I will provide you 
more information to follow up. I want to, before my time 
expires, go to the larger issue that affects all of American 
agriculture, and that is the application of pesticides and 
herbicides, and EPA's registration process.
    For most of us farmers, we live on our farms. The 
application of pesticides and herbicides is made with very 
cautious and cost-effective evaluations. We are concerned about 
the health impacts. We are concerned about the economic 
impacts. You are required to re-evaluate your process on 
registrations every 10 years, but it seems the recent 
announcement portended for the adoption of precautionary 
principle. Can you comment on your precautionary principle, and 
do you believe that zero risk is possible when using 
application of herbicides and pesticides?
    Ms. McCarthy. Sir, we do not utilize the precautionary 
principle. Our decisions are based on the law, which is based 
on risk.
    Mr. Costa. Do you believe zero risk is obtainable?
    Ms. McCarthy. It is possible with some, but that is not the 
way in which our laws require us to look at this, and we do not 
utilize that as the----
    Mr. Costa. There have been court decisions, and my time is 
about to expire, where various applications of these pesticides 
and herbicides have been brought to the courts. And, in some 
cases we believe EPA has refused to defend its scientific 
decisions on the challenges of these courts. This is very 
serious. You are supposed to be the clearinghouse.
    Ms. McCarthy. Yes. Well, we vigorously defend our decisions 
in court. We do that because we believe we did the right 
decision, based on science and the law. There are times when 
even a vigorous defense does not carry the day in the court, 
and we have to abide by those decisions. But in no way are we 
backing off of our decisions, and the way in which we have 
always made them, which is based on the law that exists. And we 
are continuing to apply that, and vigorously defend it.
    Mr. Costa. Well, thank you, Mr. Chairman, and I will have 
more information to follow with the witness. Thank you.
    The Chairman. The gentleman's time has expired.
    I now recognize Mr. Rogers from Alabama, 5 minutes.
    Mr. Rogers. Thank you, Mr. Chairman, and, Administrator 
McCarthy, thank you for being here today. I am sure it is not a 
surprise to you when I tell you that me and my farmer 
constituents are very worried and upset over the number of 
regulations coming out of the EPA that negatively impact them. 
First of all, are you cognizant that there are those concerns 
by American farmers, and is there anything that you are 
planning to do to address that perspective that they have of 
your Agency and its regulations?
    Ms. McCarthy. Well, yes, I am aware. There is a lot of work 
that we need to do to establish a stronger trust relationship 
between the agriculture community and EPA. I have been working 
hard for the last few years, trying to get out to farms, 
meeting with every farmer, rancher, and forester that wants to 
sit down. I am trying to work through the issues, and listen 
closely, and learn.
    Mr. Rogers. Are there any fundamental changes that you 
think that you are going to be able to make--plan to make that 
would remedy or alleviate some of those concerns?
    Ms. McCarthy. Well, to implement the laws as effectively as 
I can. As I noted, we have a number of voluntary programs that 
we are initiating back and forth. We have new advisory groups 
being started. I think the most important thing we can do is 
listen to one another, and try to identify the path forward 
that meets our shared goals, because we certainly share the 
goals of wanting to protect the environment.
    Mr. Rogers. Well, I agree. I think that listening is a good 
first step, but you also have to be prepared to act.
    Ms. McCarthy. Yes.
    Mr. Rogers. And it may mean act in a different way. But 
anyway, I am glad you mentioned voluntary programs. I believe 
we need to encourage programs that provide farmers with the 
resources they need to work with states, and not the EPA, on 
water quality problems. Congress did not give the EPA 
regulatory authority over family farmers. I am concerned that 
the EPA is moving away from voluntary programs that have 
verifiable results, and instead intends to create burdensome 
regulations. Do you agree that voluntary programs are 
important, and an effective way to help reduce pollution, or is 
the EPA trying to expand its regulatory authority over non-
point source pollution?
    Ms. McCarthy. Absolutely I agree that voluntary programs, 
as well as technical support and funding support from the 
Federal Government, is an essential way in which we need to 
move forward and work together, and that is the vast majority 
of our relationship.
    Mr. Rogers. Okay. Where in the Clean Air Act did Congress 
give the EPA authority to regulate sustainability of 
agriculture, non-production practices on farm fields? I don't 
see that precedent anywhere.
    Ms. McCarthy. Under the Clean Air Act, is that what you 
said, sir?
    Mr. Rogers. Yes.
    Ms. McCarthy. I do not know whether the word sustainability 
is written into any law. I think it was an outcome of 
understanding, that we need to understand the lifecycle, and 
all of the challenges associated with clean air and other 
requirements that are being placed on our constituencies, 
including farmers, ranchers, and foresters. And it was an open 
dialogue to understand how our rules can enhance not just their 
health and our health, but our viability as a sector. I think 
that is what sustainability is intended to make sure, that we 
are thinking about this in a common sense, holistic way, not a 
narrow, media by media approach.
    Mr. Rogers. I agree, but it didn't give the legal authority 
to the EPA. What I am looking for is: do you see in that Act 
the legal authority to regulate sustainability?
    Ms. McCarthy. We do not regulate sustainability. We do 
regulate pollutants under the Clean Air Act, one of which are 
greenhouse gases. If that is what you are referring to, sir, 
that is because, under the Clean Air Act, the Supreme Court 
clearly told us that we had to look at greenhouse gases as a 
potential pollutant, and if we found that they were an 
endangerment, then we had to take appropriate action. That is 
what we are actually doing.
    Mr. Rogers. That is the precedent I am looking for. Could 
you have someone on your staff get me a copy of that Supreme 
Court interpretation?
    Ms. McCarthy. Absolutely.
    Mr. Rogers. I would appreciate that. And finally, GAO 
released a legal decision that the EPA was violating publicity, 
propaganda, and anti-lobbying provisions contained in previous 
appropriations bills and your Agency, according to GAO, has 
been using social media for covert propaganda. What is your 
side of that?
    Ms. McCarthy. Well, as you might guess, we don't agree. We 
do not believe that we have violated any provisions. The GAO 
looked at thousands of social media posts that we actually do 
every day, because that is how we do our outreach and 
education. That is all that they were. They found two instances 
that raised questions for them. We disagree with their 
decision, but we certainly are working with OMB to make sure 
that we have followed every one of their procedures, and we do 
everything we need to do.
    Mr. Rogers. Thank you, ma'am. I yield back.
    Ms. McCarthy. Thank you.
    The Chairman. The gentleman's time has expired. Mr. Walz, 5 
minutes.
    Mr. Walz. Well, thank you, Mr. Chairman, and thank you 
Administrator for being here with us today. I appreciate the 
work that you have put on this. I appreciate the visits you 
have taken to farm country, and am curious a little bit about 
what you are hearing out there. But I remain the optimist that 
I do think it is possible in this nation to produce food, to 
continue to feed, fuel, and clothe the world, at the same time 
addressing real world issues of clean air, clean water, and 
environmental sustainability. And I think that is what we are 
all trying to get at.
    A statement that comes up often with my producers out 
there--and these are folks that are committed to this, they 
don't deny the science, they understand the importance of 
regulatory humility.
    Ms. McCarthy. Did you say----
    Mr. Walz. Regulatory humility. Just a sense of working 
with--I have used the term before--a bit of a bunker mentality 
about all these things keep coming down without asking us. And 
Mr. Rogers was getting at it, and I agree, I am very proud of 
the work that this Committee did, and many of our folks working 
on the last farm bill, on the conservation piece of it. That 
conservation title was lauded by many as being one of the 
strongest ever across the spectrum, from producers to 
environmental groups.
    And you kind of hinted at it, but are those working? Are 
those making a difference? Because my attitude on this is we 
are far better ahead if we can prevent a problem than dealing 
with it afterwards, and getting into the courts, and everything 
else that comes with that. Are some of those working? And if 
you could maybe pick out one that you think is the way to go?
    Ms. McCarthy. Yes. I think the conservation efforts are 
absolutely working, and you can see that in many locations. Do 
we need to do more? Absolutely, but that is the approach in 
which EPA certainly prefers and takes. And, if I wanted to 
highlight any, I think that it would be in the Great Lakes 
area, areas in which we are actively supporting conservation 
efforts, and doing that in a way that will help us prevent 
pollution into the Great Lakes, which are causing these harmful 
algal blooms.
    There is a collaborative spirit. There is funding. There is 
technical resources provided to this. These are the kind of 
programs we need to have to move forward, and EPA is working 
every day with USDA and the NRCS to see how we could advance 
their mission as a way to advance our own. I do not need to 
duplicate it. I need to respect what they do, and help support 
that, and identify ways of appropriately expanding that in 
areas where we find there are challenges.
    Mr. Walz. I think that story needs to get out there, 
because I agree. This is about helping us reach a common goal, 
not telling us. And I think that telling us attitude, whether 
it is perceived reality, or is reality and a lot of people feel 
that way.
    Ms. McCarthy. I know.
    Mr. Walz. And, if I could, some of it comes from this 
statement. This is the one that is confusing on this. Two 
statements were made. I think your Agency stated that three to 
five--approximately, I am not holding you to that--three to 
five percent more jurisdictional waters, but we were also told, 
and the red line for me was, if you didn't need a permit 
before, you won't need one now. You can't have both those 
statements, can you?
    Ms. McCarthy. Yes, you actually can, and let me just try to 
explain it. The increase in jurisdictional water determinations 
is because the rule is much more specific about what is 
jurisdictional and what is not, so there is not significant 
amount of time wasted asking in areas where there is no 
jurisdiction, or where we well know that, from our history, 
there is a direct hydrologic connection that is significant 
enough to warrant protection. But in terms of the agriculture 
community, there is no added permit burden.
    Mr. Walz. Unequivocally? I can go back----
    Ms. McCarthy. None.
    Mr. Walz.--to every one of my producers and say, the way 
you are doing things now, if you were up to standards, nothing 
changes?
    Ms. McCarthy. That is correct. We have actually expanded 
clarity on some of the exemptions and exclusions so that we can 
make that clearer and clearer as time goes on.
    Mr. Walz. Thank you. I am going to segue again just a 
little bit, because we mentioned that collaboration with USDA. 
What conversations happened on RFS, if you could, in dealing 
with----
    Ms. McCarthy. With USDA?
    Mr. Walz. Yes.
    Ms. McCarthy. Lots, at every level.
    Mr. Walz. Extensive all the way through the----
    Ms. McCarthy. It is, both in how we look at feedstocks, how 
we look at those lifecycle impacts, to the numbers we should 
put in, to what can be produced, what can be consumed, what can 
USDA do, like their advancing of blender pumps, what does EPA 
need to do to make sure those blenders can actually go out 
there, and all those blends be utilized? We work pretty 
constantly on RFS together.
    Mr. Walz. And I appreciate that, and I know you do it to 
the best of your ability, the idea is to get out there and make 
those statements, show that collaboration. And, again, coming 
back to that regulatory humility, that we are in this together, 
we have common goals, but----
    Ms. McCarthy. That is a term I will take to heart as I 
leave here. Thank you so much.
    Mr. Walz. Thank you, ma'am.
     I yield back.
    The Chairman. The gentleman yields back. Mr. Thompson, 5 
minutes.
    Mr. Thompson. Thank you, Mr. Chairman. I haven't seen a lot 
of regulatory humility, at least since I have been here. It is 
more, unfortunately, just my opinion, regulatory arrogance. 
Administrator, thank you for being here. I appreciate you 
coming, sitting in the seat, taking tough questions, and your 
responses. I want to follow up on Mr. Rogers's questioning, the 
response to the last question on this side, regarding the use 
of social media.
    Ms. McCarthy. Yes.
    Mr. Thompson. I found it interesting, since the EPA 
disagrees with the regulations that they have been confronted 
with, and basically they disagree with the regulators that were 
responsible for that, were wrong, in your interpretation, you 
are not changing your practices. So my question is, can my 
farmers do the same thing? Can they? I mean, they disagree with 
the EPA, where there is a question of authority as a basis of 
legislative language, as a basis of a now growing trend, and 
serious numbers of Supreme Court rulings. Do they get the same 
pass that it seems like your Agency is choosing to do when your 
feet are held to the fire under regulations?
    Ms. McCarthy. We are not doing anything that would skirt 
the decision that GAO made, their interpretation of the law. 
Our Office of General Counsel believes that they are incorrect 
in their interpretation.
    Mr. Thompson. So----
    Ms. McCarthy. Nevertheless, we have----
    Mr. Thompson. So what you are saying--okay. We gave you----
    Ms. McCarthy. But nevertheless, we are actually working 
with----
    Mr. Thompson. If my farmers get an army of----
    Ms. McCarthy.--OMB on what the appropriate response is to 
that. So they do they have their opinion, we will respond 
appropriately to it, but we still have a right to say that 
legally we don't think they were correct.
    Mr. Thompson. Sounds like----
    Ms. McCarthy. That is all.
    Mr. Thompson.--my farmers would be better off if they had 
an army of government paid attorneys, that is my question, 
though. That just happened to come up. Many believe that the 
Chesapeake Bay TMDL represents a massive seizure of state 
government power by your Agency, and will serve as a blueprint 
for regulating watersheds around the nation. Now, through its 
standards, controls, and rigid rules the Agency is setting the 
stage for taking over many, if not all, land use decisions 
nationally. Really a private property grab, in effect becoming 
a national zoning board. The TMDL is already having devastating 
impacts on farmers. In defending the TMDL, currently on appeal 
to the Supreme Court, your Agency has defended it, saying that 
the states are developing their own standards.
    Now, let me read to you what one state in the Chesapeake 
Bay Watershed, Delaware, not my state, wrote of this voluntary 
procedure in its watershed improvement plans. The state wrote 
that, if the program fails to meet standards acceptable to the 
Agency, then ``the EPA has identified a set of potential 
consequences to impose. These consequences range from the EPA 
taking over responsibility for developing the plans to 
increasing their regulatory oversight, and extending their 
regulatory authority to additional sources of pollution.'' In 
short, this quote is articulating that if each state's 
watershed improvement plan doesn't meet EPA standards, the EPA 
can then force its own plan on the states, along with punitive 
actions.
    My question is, with all of this authority, in what sense 
was there anything voluntary about this process? Your Agency, 
directly and indirectly, told states that it wanted what it 
wanted, made it clear that there would be consequences to not 
delivering on what it wanted, the standards and plans it 
expected. How is that voluntary?
    Ms. McCarthy. Well, sir, let me try to answer that 
question. The Chesapeake Bay TMDL was an opportunity for a 
number of states who share a common, both environmental and 
economic, interest in having a healthy Chesapeake Bay. That 
program allowed them the opportunity to actually meet 
compliance, with reducing the standards necessary to get that 
healthy again in their own way.
    Mr. Thompson. And as the Chairman of the Subcommittee that 
includes watersheds, I love the Chesapeake, and----
    Ms. McCarthy. Right, I know.
    Mr. Thompson.--we are achieving that, but we are just--I am 
talking about the overreach here.
    Ms. McCarthy. But we have never----
    Mr. Thompson. That is just----
    Ms. McCarthy.--actually had to intervene. There is great 
progress being made through the efforts that each state has 
been taking. They do care about the Chesapeake, and they are 
making progress. The question was asked, what if people don't 
do anything? Well, there is no question that TMDLs are a 
regulatory requirement, and so there are things that we could 
do if there isn't continued progress as anticipated. We have 
never had to use that.
    Mr. Thompson. Well, ma'am, I----
    Ms. McCarthy. And we don't expect----
    Mr. Thompson.--would refer you to the transcripts of when 
our Subcommittee on Conservation and Energy Watersheds met, and 
your individual in this Philadelphia office clearly said this 
was not a regulation because it was voluntary, and then it was 
some of the most confusing testimony we ever heard, because it 
is being aggressively implemented as a regulatory action, yet, 
clearly it was overreach to the 10th degree. And I appreciate 
your response, but the uncertainty is still in there.
    The Chairman. The gentleman yields back. Ms. Fudge, 5 
minutes.
    Ms. Fudge. Thank you very much, Mr. Chairman, and thank 
you, Administrator McCarthy, for being here today. I am going 
to go strictly local today.
    Ms. McCarthy. Okay.
    Ms. Fudge. I live on the banks of Lake Erie in Ohio. Lake 
Erie provides drinking water to millions, and supports 
thousands of jobs, and contributes over $1 billion to our local 
economies. Yet harmful algal blooms are only intensifying each 
year, and we are persistently faced with the threat of open 
dumping that we believe to be harmful sediment into open Lake 
Erie, and we believe that it is an adverse decision by the Army 
Corps.
    Despite the great progress made in reversing past 
environmental damage, we find ourselves locked in an ongoing 
battle over this seemingly non-controversial issue. The EPA 
plays a critical role in protecting drinking water and the 
health of our lakes. What are you and your Administration doing 
to ensure the continued growth and recovery of Lake Erie?
    Ms. McCarthy. Well, I am familiar with the issue you raise 
with the Army Corps, and I am hoping my understanding is 
correct, that the Corps is working with the state, and all the 
constituents, to identify ways to stop dredge disposal in 
Western Lake Erie. But as you also know, we are working very 
hard through our Great Lakes Initiative to actually understand 
the science in Western Lake Erie, understand where the sources 
of the nutrients that are contributing to those algal blooms 
are, and we are actually supporting it with $11 million from 
EPA's funds to try to help those upstream farms and agriculture 
to find ways of taking conservation efforts, and other 
voluntary actions, that will begin to make a real dent in the 
challenge we are facing in Western Lake Erie.
    Ms. Fudge. Well, thank you, but I certainly hope that you 
would check further, because it is my understanding at this 
point that even though a court has decided that it is not 
appropriate for them to dump the sediment into the open lake, 
the Army Corps has decided that they are not going to comply 
with the court order.
    Ms. McCarthy. I didn't hear that.
    Ms. Fudge. And so it is important that we move 
expeditiously to determine why, and why they have not requested 
the resources that are necessary to contain the sediment.
    Ms. McCarthy. Okay.
    Ms. Fudge. So I would ask that you would check that 
further?
    Ms. McCarthy. I am happy to do that.
    Ms. Fudge. Thank you. The growth of urban agriculture is 
vital to solving the issue of food deserts in many low-income 
neighborhoods, many of the ones that I serve. In post-
industrial cities, such as Cleveland, historical contaminants 
in the soil can stall the growth of these programs. What role 
is EPA playing in ensuring urban land is safe for farming?
    Ms. McCarthy. Well, one of the efforts that I mentioned 
early in my oral testimony was the Local Food, Local Places 
effort, which adds enormous opportunities for urban communities 
that are literally food deserts, and to open up and do 
planning, and to bring Federal resources to the table that is 
really focused on food first, instead of as an afterthought.
    There is a great change that is happening in urban areas, 
understanding the need for locally grown food, and the value 
that that can bring not only for the health, but the vitality 
of the community. I would really encourage anybody's active 
participation in the Local Food, Local Places initiative, 
because that can bring brownfield redevelopment resources to 
the table that would address the soil contamination issues you 
are identifying. Many of those turn into vital places for 
communities to gather and grow food, so do not give up in an 
urban area on the ability to grow food, and to make that part 
of the community revitalization efforts that everybody is 
looking for.
    Ms. Fudge. Thank you. And last, seasonal agricultural 
runoff is a factor to the growing problem, of course, of algal 
blooms in the lake. What steps is EPA taking to address the 
lingering pollutants still contaminating river and stream 
sediment?
    Ms. McCarthy. Well, a couple of things. We have mentioned 
the Great Lakes Initiative, but most importantly, that is our 
collaboration with USDA, as well as looking at areas of concern 
in the Great Lakes where we know we have significant sediment 
and water contamination. So it has to be a combination of all 
of those efforts. It is not just about stopping what might 
continue to be coming in, but it is looking at those hot spots, 
if you will, so that we can continue to make progress, which we 
have made tremendous progress on. But that is one of the three 
areas that the Great Lakes Initiative is focusing on in the 
coming years.
    Ms. Fudge. Thank you very much. Mr. Chairman, I yield back.
    The Chairman. The gentlelady yields back. Mr. Neugebauer, 5 
minutes.
    Mr. Neugebauer. Thank you, Chairman. Thank you for holding 
this hearing. Administrator McCarthy, in my area, the 
prevalence of herbicide resistant pig weed has become a major--
--
    Ms. McCarthy. I am sorry, where are you? I am sorry, I 
can't see you. Thank you. This layered look is hard for me.
    Mr. Neugebauer. I even got in a taller chair so you could 
see me. In my area, the prevalence of herbicide resistant pig 
weed has become a major problem that producers are having 
trouble combating. With everything else that is going on in the 
cotton industry right now, fighting this pig weed problem is 
the last thing they need, and it is becoming one of the 
greatest costs many producers face. USDA has approved Dicamba 
and 2,4-D, known as Enlist Duo, for use on cotton varieties 
with herbicide tolerant traits. EPA is now the sole holdup in 
getting this new, and severely needed, technology out to our 
producers. Can you give the Committee any update on where 
things stand at EPA, and what is the continued holdup by EPA?
    Ms. McCarthy. Is this the Dicamba? In early 2016 we 
actually proposed for public comment a regulatory decision on 
Dicamba for the exact reasons you are talking about. We know 
that there is significant interest in this. There has been 
tremendous work on the science side. After the comment period 
we are going to review those comments, and see how the Agency 
can move to a final rule, so that we can get this done and over 
the finish line.
    Mr. Neugebauer. Now, could you kind of give me some 
encouraging timeline here that folks could look forward to?
    Ms. McCarthy. Sir, we are working as hard as we can. We 
will get it done as soon as we can. If you would like me to 
reach back to you after the hearing, I can get more details on 
where we might be.
    Mr. Neugebauer. That would be helpful.
    Ms. McCarthy. All right.
    Mr. Neugebauer. Enlist Duo also ran into some trouble last 
fall with EPA's decision to request that the court remand 
registration back to EPA for further review. This is only the 
first time ever that EPA has attempted to vacate a pesticide 
registration through a court action currently under FIFRA, and 
EPA is required to comply with a number of procedural 
safeguards before a pesticide registration can be canceled, 
which it has failed to do. What was the Agency's rationale for 
taking such an unusual step of asking the court to require EPA 
to review the registration of a product so recently approved 
for use, and why is the Agency now trying to use the courts as 
a means of regulation?
    Ms. McCarthy. Actually, we weren't really trying to do 
that, sir. The 2,4-D decision that we made on Enlist Duo was a 
controversial one, as you may know, but we followed the 
science, and we followed the law. The awkward situation we 
found ourselves in is after the decision was made, while it was 
being challenged in court by the those that disagreed with our 
registration, we identified information that the manufacturer, 
Dow themselves, had put out, in other public venues, that 
raised concern that we did not have the full science data to 
make the decision in the most solid way we could, and actually 
address what might be synergistic effects.
    So instead of waiting for the court to tell us that we had 
failed in our science decision, we wanted an ability to take 
that back, to work with Dow, to get additional information to 
address the issue and to move it forward again, which is 
exactly what we are doing. We are actually working with Dow 
about what the science is that they put out in other venues, 
what data did they have, what data might we need to actually 
re-do this decision in a way that we think will be legally 
solid and respectful of the full range of science.
    Mr. Neugebauer. Now, as to the question that you have not 
followed the law procedurally on this. Do you believe you have?
    Ms. McCarthy. We do, and we think we actually did it in a 
way that will get to a decision much more quickly. The 
challenge is that Dow did not give us the full range of data, 
and we found it in another venue that was publicly available. 
So when we found that out, we worked with Dow, and we have a 
system to move forward to respect the full range of science 
that we are required to look at.
    Mr. Neugebauer. I am always interested in a timeline, you 
said quickly, and I have learned quickly in west Texas and 
quickly in Washington, D.C. doesn't necessarily have the same 
meaning.
    Ms. McCarthy. I will double check when I go back, but I am 
pretty sure that we have already received a lot of the 
information that we have asked Dow to do on 2,4-D, so we don't 
think that there is going to be a significant delay in the 
reconsideration of this and moving it forward.
    Mr. Neugebauer. Well, on those two issues, Administrator, 
if you could maybe have your folks kind----
    Ms. McCarthy. I will.
    Mr. Neugebauer.--of give me a timeline so that I can report 
back to the cotton folks?
    Ms. McCarthy. I am more than happy to do that.
    Mr. Neugebauer. With that, Mr. Chairman, I yield back.
    The Chairman. The gentleman yields back. Mr. Aguilar, for 5 
minutes.
    Mr. Aguilar. Thank you, Mr. Chairman. Thank you, 
Administrator, for being here. I too will ask a little bit of a 
local question, if you don't mind. I represent the community of 
San Bernardino, that has been in the news recently, obviously, 
for some terrible acts. While climate change affects us all, 
this is incredibly personal for me, and the community that I 
represent. I can recall smog days growing up, where we weren't 
allowed outside because of the air quality levels, and this is 
particularly important because our community sits at the base 
of a mountain range that captures smog and air quality issues 
that mostly generate from out of the area and blow in with the 
trade winds.
    I believe the National Ambient Air Quality Standards are a 
great benchmark for communities to strive for in order to 
improve pollution levels, however, San Bernardino has been in 
the unique predicament due to the fact that the smog from Los 
Angeles also contributes to the pollution in our region. Are 
there resources and tools that the EPA can offer San Bernardino 
County as it continues to work toward a management plan to 
improve air quality? If not, does the EPA plan to provide any 
sort of regulatory relief, or, as Mr. Walz coined, regulatory 
humility for counties and areas that are not in compliance?
    Ms. McCarthy. Well, let me begin by expressing my 
sympathies----
    Mr. Aguilar. Thank you.
    Ms. McCarthy.--to you, and to those in your community. The 
National Ambient Air Quality Standards rightfully establish by 
law health standards that we all strive for. We well recognize 
that California is challenged in meeting those, and there have 
been some unique tools developed that we had the authority to 
manage that have provided direct assistance for new 
technologies and other efforts to support the state's 
aggressive effort at looking at these areas.
    There are also tools built into the law itself, so that, if 
you have a difficult challenge, you can't meet it, provides 
additional time and opportunity to get that done. And part of 
the value of the state planning process, and really the 
aggressive and--maybe aggressive isn't the word, but the 
collaborative process, the outreach that Region 9 does to its 
communities to try to work with them hand in hand to address 
these challenges is really of great value.
    So I am more than happy to make sure that folks come and 
sit down, and see if there are particular issues of support 
that your community may need to build into a state plan that 
would help you achieve these standards quickly. But I want to 
just reinforce the fact that the law does not, nor does EPA, 
ever require more than can be done. We know that there are 
transport challenges, and there are unique geographic 
challenges that California faces. So while we hope to continue 
to make progress, we understand that that will take time, and 
it will take a collaboration, and it will take new technologies 
to advance this. And whatever is coming in from other 
communities is going to have to be a collaborative, multi-
community effort.
    Mr. Aguilar. Sure. We just want to make sure that that is 
part of the discussion. And there has been a discussion and 
some flexibility in the past. We just want to make sure that 
those----
    Ms. McCarthy. We will keep that up.
    Mr. Aguilar.--standards are still in place. And if we could 
follow up with your staff to have----
    Ms. McCarthy. That would be great.
    Mr. Aguilar.--a little bit of a deeper dive, that would be 
very helpful to my office. But with that, I will yield back, 
Mr. Chairman. Thank you.
    The Chairman. Thank you, Mr. Aguilar. The gentleman yields 
back. Mr. Gibbs, 5 minutes.
    Mr. Gibbs. Thank you, Mr. Chairman. Administrator, first of 
all, thank you for being here. Let me start out for 
clarification, my colleague, Ms. Fudge from Ohio, on the Lake 
Erie issue, there are two separate issues, the algae bloom 
issue in Western Lake Erie, you are correct, they do dredge and 
dispose on the lake. The issue which she was unclear on is the 
Cleveland Port issue. The Cleveland Port issue is a dredging 
issue. It is about PCBs in the State of Ohio, and the Ohio EPA 
has sued the Army Corps of Engineers over this issue. And it is 
interesting, your Agency has been silent on this issue. So I 
want to bring that to your attention, okay? And that is two 
separate issues there on Lake Erie.
    I do want to talk about: in your testimony you talk about 
Waters of the United States Rule. I agree with you on one 
aspect of it. Farmers do want clean water and drinking water, 
so we agree on that. But my concern is, and it is evident by 
what has happened, within 24 hours, when you filed the final 
rule in the Federal Register, nearly 30 states filed a lawsuit. 
Now it is over 32 states have filed a lawsuit, and numerous 
organizations and entities are against this. And so it is clear 
that there is concern about this, and obviously the states, it 
erodes their states' rights.
    And it needs to be made clear, when the Clean Water Act was 
passed, the intent of Congress was it was supposed to be a 
partnership between the Feds and the states, where the states 
would implement and enforce the Clean Water Act under the 
guidance of the EPA. Now, you made a statement here to answer 
to one of the questions you insinuated that if the rule had to 
be extended to include more waters, those waters are regulated. 
You are insinuating that states aren't regulating waters. Now, 
I, as a farmer, can't go out and dump my hog manure in any 
stream that is not WOTUS, Waters of the United States. I would 
be breaking the law. So I want to make it clear to the public 
that waters that aren't under the authority of the Federal 
Government are being regulated in that partnership agreement. 
And you agree with that, correct?
    Ms. McCarthy. In many states.
    Mr. Gibbs. But you do insinuate that, and so----
    Ms. McCarthy. Well, it wasn't intended, sir. We are 
partners with the state----
    Mr. Gibbs. Okay. Now, I also have a----
    Ms. McCarthy.--they are primarily responsible.
    Mr. Gibbs. I also have a concern that what is going to 
happen is it is going to require more permits, Army Corps of 
Engineers, and inefficiencies. But we risk the potential to go 
backwards in the progress we have made since 1972 in water 
quality, and protecting the environment in this country. 
Because when you add on so much more red tape and bureaucracy, 
people, at some point, throw their hands up in the air and say, 
``Well, I might not necessarily have gone the extra route I 
would have done. I am going to do just enough to get by, but I 
am not going to do it because this is just a bunch of nonsense, 
and a bunch of red tape.'' And the bureaucrats go crazy on 
them, so I want you to be aware of that fact, that this rule 
can make us actually go backwards in--and we are eroding that 
partnership agreement that was set up in 1972 with the states. 
And obviously, over 30 states have sued you over this, you 
ought to pay attention to that.
    Now, I want to also get to the part about the GAO Inspector 
General report that came out and said that the EPA used covert 
propaganda to bias and skew the comment period. I know some of 
the people are poo-pooing this, this is not a big deal. I think 
this is a big deal because it goes to the integrity of the 
whole comment period process. I mean, the process is there so 
the stakeholders can put in what they need to, comments, and it 
is up to the regulators to use their due diligence to figure 
out and make the best rule that works, and protects the 
environment in this case. And here you have the Inspector 
General of the GAO come out and say, you broke the law, and it 
goes to the integrity of the system.
    So my question is what has the EPA done to initiate the 
reporting violation under the Anti-Deficiency Act, a copy to 
the Comptroller General, and the Congress, and the President, 
as required by the Anti-Deficiency Act, as you reported to us. 
What resources were expended on these legal activities, both 
monetary and full time equivalents? What internal action has 
been taken in your office to make sure this doesn't happen 
again, and has any internal action been taken to punish people 
that broke the law in this case? I will let you answer those 
questions.
    Ms. McCarthy. Well, thank you, sir. I don't think that 
folks in the Agency broke the law, but let me answer your 
question directly. We are working with OMB--there is a draft 
letter at OMB to make sure that we are following our 
obligations under the law to respond appropriately to the GAO. 
I think the word propaganda is always construed as something 
horrible. The propaganda that they were referring to was not 
that we lobbied Congress. It was not that we said----
    Mr. Gibbs. No, you were lobbying people to lobby us, 
because you were trying to educate them----
    Ms. McCarthy. No, actually----
    Mr. Gibbs.--that this was what you guys want. You guys are 
actually proponents of this, and now you have all the state 
EPAs suing you----
    Ms. McCarthy. The propaganda----
    Mr. Gibbs.--over it.
    Ms. McCarthy.--issue was that----
    Mr. Gibbs. Wake up.
    Ms. McCarthy. The propaganda issue was that we used a 
system that OMB approves under their guidelines, which was 
basically a general message saying, I really care about clean 
water. And the GAO was worried that when other people----
    Mr. Gibbs. Because you use a----
    Ms. McCarthy.--retweeted that----
    Mr. Gibbs.--system called----
    Ms. McCarthy.--they didn't identify----
    Mr. Gibbs.--Thunderclap where they couldn't----
    Ms. McCarthy.--it as an----
    Mr. Gibbs.--trace it back to the EPA?
    Ms. McCarthy.--EPA message.
    Mr. Gibbs. Did you use a system called Thunderclap that 
couldn't be traced back to the people putting it out? Is that 
true? Is that----
    Ms. McCarthy. I am sorry?
    Mr. Gibbs.--my understanding--pirate social media called 
Thunderclap, I believe----
    Ms. McCarthy. That was the social media----
    Mr. Gibbs. And that that can't be traced back to the people 
that are putting it out? Is that true?
    Ms. McCarthy. No. What happened is we put it out, other 
people re-tweeted it, and when they re-tweeted it, GAO thought 
that it wasn't their message, it was EPA's message, and we 
didn't properly identify it as such. That is what they said. 
But it was a general message, ``I like clean water.'' The other 
was a blog that had a hyperlink where we referenced a really 
cool program that----
    Mr. Gibbs. Well, all I know is----
    Ms. McCarthy.--that NGO was doing----
    Mr. Gibbs.--as an oversight----
    Ms. McCarthy.--and they were worried about.
    Mr. Gibbs.--oversight, the GAO said you broke the law, so--
--
    Ms. McCarthy. But I don't want to minimize it, sir. We will 
pay attention to what GAO said, and we do have a letter in the 
process to meet all obligations. We just disagree that it was a 
problem.
    The Chairman. The gentleman's time has expired. Ms. Adams, 
5 minutes. Ms. Adams?
    Ms. Adams. Thank you, Mr. Chairman, and Madam 
Administrator, thank you so much for being here. While many are 
concerned about Federal overreach and environmental management, 
actions by the State of North Carolina resulted in tens of 
thousands of tons of coal ash spilling into the Dan River in 
2013, and the state refused to use its own authority to enforce 
proper maintenance and relocation of coal ash ponds at high 
risk of spilling into other drinking water.
    Administrator McCarthy, it is important that we together 
defend and uphold the EPA's final rule on the disposal of coal 
combustion residuals from electric utilities. EPA's final rule 
on coal ash disposal can only be enforced by states or by a 
citizen that sues a company, or a state that violates the 
regulation. It is for this reason that I am drafting 
legislation to strengthen protection and enforcement of rural 
water sources, which would provide rural communities with the 
same requirements that citizens in North Carolina now enjoy. 
Specifically, the bill would require coal ash pond owners and 
operators to be transparent in their surveying and monitoring 
of the quality of water in our communities. The bill mirrors 
laws that have already been passed by the North Carolina 
General Assembly.
    My question is, given the continuing threats of coal ash 
disposal, what is EPA doing to assess and prevent drinking 
water contamination and the risk of catastrophic collapse?
    Ms. McCarthy. Well, as you know, we take this issue very 
seriously as well. Certainly there have been disasters that we 
need to make sure don't get repeated. So, as you know, we just 
recently finalized the Coal Ash Rule. That looks at two things. 
One is the structural stability of those units, so that we can 
make sure that they are stable, and they are being properly 
inspected, and, if necessary, repaired. The second is to make 
sure that groundwater is protected and actually cleaned up. And 
that rule has requirements for both of those efforts. And we 
have information on the web so that people can see what is 
being done, and what we have identified, in terms of our 
assessment of that structural integrity so that information can 
be available to the surrounding communities.
    Ms. Adams. Thank you. Will EPA provide technical assistance 
to low-income and minority communities so they are aware of, 
and can understand, the information about coal ash dumps that 
utilities are beginning to disclose?
    Ms. McCarthy. Congresswoman, this is the first time I am 
aware that you are contemplating this type of legislation. We 
are happy to work with you on language around that, and talk 
about what authorities the Agency might have to support this 
effort, even in advance of that legislation moving forward.
    Ms. Adams. All right, thank you. The Center for Public 
Integrity found that your Civil Rights Office has dismissed 
nine out of every ten claims by communities alleging 
environmental discrimination, and have never issued a formal 
finding of a Title XI violation. Given this poor performance 
record of EPA's Office of Civil Rights, do you have any 
thoughts about why EPA hasn't ever made a finding of 
discrimination under this Title?
    Ms. McCarthy. Well, it is easy, from that record, to 
understand that the Agency has faced challenges in dealing with 
our Title XI complaints. One of the things that I have done 
since coming here is to try to aggressively tackle that issue. 
We are really committed to building a model civil rights 
program, particularly how we handle these. In the last 2 years 
we have new leadership in our office. We have developed a 
strategy to manage that docket of complaints more effectively. 
We, just this fall, released our external compliance strategic 
plan, a new civil rights toolkit, so we are doing what we need 
to do to get up to speed. But that doesn't mean we don't have a 
history that we need to acknowledge, and use that history to 
inform how we can be a model agency, moving forward. And we are 
trying very hard to make sure that we do that.
    Ms. Adams. Well, I certainly hope it improves. It is not 
very impressive right now. But thank you very much for your 
comments, and, Mr. Chairman, I yield back.
    Ms. McCarthy. Thank you.
    The Chairman. Ms. Adams yields back. Mr. Austin Scott, 5 
minutes.
    Mr. Austin Scott of Georgia. Thank you, Mr. Chairman. 
Ma'am, thank you for being here. I want to go back real quickly 
to what Mr. Neugebauer from Texas was talking about, with the 
Dicamba and the 2,4-D issue.
    There have been several things that have been approved by 
the USDA for months, and farmers start planting cotton in his 
state in March. In my state it is more in April, but it takes 
time to get the chemicals produced, and through the 
distribution network, and to the farm. And if you all take much 
longer, quite honestly, they are not going to be available for 
us this year. And so I appreciate your commitment to help the 
farmer. I hope that we will see you act on these pending 
registrations sooner rather than later. And that is one of the 
breakdowns that we have between the government and the public, 
and the farmer is that it seems the people in the agencies have 
no idea when farmers even plant their crops, and what the 
agencies are doing to the cost of those crops. And can you tell 
me what cotton is trading for? Do you know?
    Ms. McCarthy. No, I can't, sir, no.
    Mr. Austin Scott of Georgia. It is below the cost of 
production right now, and so are a lot of the other 
commodities. And so when you take an area like mine, that 
produces a tremendous amount of cotton every year, and cotton 
is below the cost of production, you would typically look to 
another commodity. But they are also below the cost of 
production. And I appreciate your comment that you are trying 
to help the farmer and the farm, but the government is getting 
in the way of the farm being able to survive through these 
tough economic times. And things like approving these chemicals 
sooner rather than later would at least help us determine what 
crop we can plant.
    And I want to go to the neonic issue right now, and I 
certainly understand the value of pollinators. I mean, without 
bees, you have lost the majority of the food in the world. But 
there are situations with the pollinator, and the preliminary 
risk assessment, and specifically cotton, which I was talking 
about earlier, is a self-pollinating crop, and it doesn't 
require bees. So did the EPA take that into account as part of 
its assessment with pollinators, that cotton does not require 
bees for pollination?
    Ms. McCarthy. I will have to go back, sir. Which chemical 
are we talking about in particular?
    Mr. Austin Scott of Georgia. The neonics as a whole, the 
whole class.
    Ms. McCarthy. Certainly. We certainly are. We are not 
making broad brush decisions on neonics. We are looking at each 
of them. And, in fact, the decisions that we have been 
proposing have been very specific to look at being specific to 
the crop, as well as the time of year----
    Mr. Austin Scott of Georgia. Let me----
    Ms. McCarthy.--and what we can do to both protect the bee 
colonies, as well as make sure that these are available when 
they are----
    Mr. Austin Scott of Georgia. Fair enough.
    Ms. McCarthy.--appropriately used.
    Mr. Austin Scott of Georgia. I will take that as a 
commitment that you will continue to work with the industry----
    Ms. McCarthy. We will.
    Mr. Austin Scott of Georgia.--and the registrants----
    Ms. McCarthy. Absolutely.
    Mr. Austin Scott of Georgia.--and I appreciate that. Are 
you familiar with the Agency's proposed rule on greenhouse gas 
emissions and fuel efficiency standards for medium and heavy 
duty engines in vehicles, Phase II?
    Ms. McCarthy. Yes.
    Mr. Austin Scott of Georgia. Well, would you agree also 
that Congress has excluded non-road vehicles that are used 
solely for competition from EPA regulatory reach?
    Ms. McCarthy. I believe that that is the case, but I am not 
as familiar with that as I am my standard rulemaking process--
ongoing rulemaking----
    Mr. Austin Scott of Georgia. Fair enough. According to the 
EPA website, Congress did.
    It is one of the things----
    Ms. McCarthy. I believe so.
    Mr. Austin Scott of Georgia. We talk a lot about the things 
that we told you to do, but there also are things that we 
specifically tell the EPA that you do not have the authority to 
do. And one of those--I agree with what you said, that you 
don't have----
    Ms. McCarthy. I don't think so.
    Mr. Austin Scott of Georgia.--the authority to regulate 
competition vehicles. I am concerned about the fact that in 
this 629+ page rule that is supposed to deal with greenhouse 
gas emissions for medium and heavy duty engines, that in the 
catch-all provision that the rule has attempted to bring back 
in to regulation competition vehicles. And I agree with you 100 
percent that you don't have the authority to do that, and so I 
appreciate you telling me that you----
    Ms. McCarthy. Well, Mr. Scott, let me get back to you. I am 
sure if that was part of the proposal, we have received a lot 
of comments on it. I am happy to close the loop with you on it. 
We certainly have not finalized that rule. We are considering 
all the comments. But if you think that there was a disconnect, 
I am happy to connect with you on it individually, if you would 
like.
    Mr. Austin Scott of Georgia. I agree with you that Congress 
specifically said that you don't have the authority to regulate 
competition vehicles, and ma'am, I appreciate your time. And it 
is just that it is very disconcerting, as an American, to see 
that in 40,000 pages of rules and regs that we have an Agency 
that would put something in a heavy duty vehicle rule that 
deals with race cars.
    The Chairman. The gentleman's time has expired.
    Mr. Austin Scott of Georgia. Thank you.
    The Chairman. Ms. Plaskett, 5 minutes.
    Ms. Plaskett. Thank you, Mr. Chairman. Good morning, 
Administrator McCarthy. I wanted to talk with you about the 
Virgin Islands. It has a very important relationship with EPA 
because of our complete surrounding by water, and our land, and 
our sea, our greatest resource, both for our farmers as well as 
for all of the industries that we take up. Several years ago, 
though, the Virgin Islands was devastated by the closure of our 
oil refinery, and that oil refinery meant that we lost hundreds 
of millions of dollars in revenue, and hundreds of millions 
more in lost economic activity. Just recently, however, the 
facility was in a bankruptcy sale, and a private equity firm 
has elected to purchase it. And that may lead to the 
restoration of more activity on the island. However, there is a 
concern that we have with regard to the EPA, and the potential 
of the EPA asking that the Government of the Virgin Islands be 
a co-permitee on its RCRA, its Resource Conservation and 
Recovery Act permit. These permits were originally put out, 
again, for Hovensa in 1999, and at no time during the renewals 
of those permits had the Virgin Islands Government been 
included in it. The Virgin Islands Government ownership doesn't 
even make up five percent of the land in this area. We were, by 
an Act of Congress, given title to the submerged lands to be 
entrusted for the citizens, and at no time has the Virgin 
Islands ever elected to operate a refinery, use the facility, 
but is really holding those submerged lands in trust.
    Now, I understand that Hovensa is no longer the owner, but 
there is real concern that we have with Region 2 taking the 
position that the Virgin Islands Government must be included as 
a co-permitee. It is our belief that Region 2's position is 
based on an overly expansive interpretation of RCRA, and is an 
unjustified departure from its longstanding Agency policy. I am 
sure my colleagues here would see that this could be a problem 
if this takes precedent, in that the you have your state and 
local governments, which may, by EPA, be forced to become a co-
permitee on hazardous waste areas back home in their own 
regions. And so we have really been reaching out to EPA, and 
particularly in Region 2, to see how we can resolve this. And I 
am not sure if you were aware of this. I wanted to bring this 
to your attention. Are you aware of any instance that EPA has 
forced a state or territory to be on a RCRA permit, based on 
its owning a small portion, five, ten percent of the land that 
a facility has?
    Ms. McCarthy. I do not know all the uniqueness of this 
situation, but it is certainly my understanding that the region 
has taken a legal position that, because the part of the land 
in which the facility is located is U.S. Virgin Island land, 
that there is a connection, and that they should have been on 
the permit. Now, having just learned this, I can't tell you 
whether we have done this before, whether there are unique 
trust responsibilities that we are not looking at, so I am more 
than willing to go back and look at the region. But it is very 
clear that RCRA has brought in communities, municipalities, and 
states into the RCRA responsibility system, even though they 
are innocent landholders, and that is respected in the process, 
but they become part of the permit in the process, moving 
forward.
    Ms. Plaskett. Well, it seems to me to be unclear why you 
would have an original permit in 1999, and renewals of that 
same permit when another owner was operating the facility. Our 
ownership has not expanded at any point in this. We have always 
had the same five percent of those submerged lands that this 
body, Congress, put on the Government of the Virgin Islands to 
hold in trust for its citizens. And now, seemingly when there 
is no titleholder anymore, because Hovensa has gone into 
bankruptcy, the EPA Region 2 has decided that the Virgin 
Islands Government must take on responsibility for hazardous 
waste and activities that the facility owners were operating 
in. I mean, what more can a territory take on? What more can a 
government that is already bankrupt take on its back?
    Now you have the owner, Hovensa, leaving, purchased by 
another entity, and the Federal Government, the Agency, is 
forcing us to take responsibility, possibly liability, for 
hazardous activity that a private owner had on 95 percent of 
that land. It just seems an expansion, because there isn't a 
private owner anymore to hold the responsibility, to put it on 
the backs of a local government that can do nothing but say, 
please don't do this to us.
    Ms. McCarthy. Well, this seems like a very unique 
circumstance. I would suggest that we follow up with this 
conversation, and it is not a decision, or an interpretation, 
that I have been engaged in. So why don't we do that?
    Ms. Plaskett. I would appreciate that so very much.
    Ms. McCarthy. All right.
    Ms. Plaskett. Thank you very much.
    Ms. McCarthy. Sure.
    Ms. Plaskett. Thank you, Mr. Chairman.
    The Chairman. The gentlelady's time has expired. I now 
recognize the gentleman from Arkansas, Mr. Crawford, for 5 
minutes.
    Mr. Crawford. Thank you, Mr. Chairman. Thank you, 
Administrator McCarthy. I know this has been addressed to some 
extent, but we can take a little deeper dive on this issue with 
the grassroots campaign effort that took place in your Agency 
which is specifically prohibited by Title 18 of the U.S. 
Criminal Code. And I don't think we have gotten a satisfactory 
answer. Have you or your legal department made efforts before 
the grassroots campaign was undertaken to ensure the EPA staff 
is familiar with the kind of activity that is prohibited under 
the Anti-Lobbying Act?
    Ms. McCarthy. We actually were following OMB guidelines 
relevant----
    Mr. Crawford. Prior to?
    Ms. McCarthy.--to the use of Thunderclap, yes.
    Mr. Crawford. Okay. That is even worse. If they have 
received training in the Anti-Lobbying Act, and then engaged in 
lobbying----
    Ms. McCarthy. We believe we actually followed those 
guidelines, yes.
    Mr. Crawford. Well, the GAO disagrees with that. And 
whether or not there can be an intent proven, the subterfuge 
and the optics of what took place there are certainly worth 
considering. I think that there are some valuable lessons here 
in the GAO's findings, not the least of which is that the 
Administration and your Agency is willing to go so far as 
breaking U.S. Criminal Code to push an agenda. We already knew 
that you were willing to go to great lengths to push that 
agenda, but this brings it into a completely different 
perspective.
    Second, the GAO findings tell us that these actions set a 
dangerous precedent for future rulemaking. So you have 
basically compromised the integrity of the rulemaking process.
    Ms. McCarthy. Sir, they never----
    Mr. Crawford. Now, excuse me----
    Ms. McCarthy.--indicated that we were----
    Mr. Crawford. Excuse me, I am on my time----
    Ms. McCarthy.--any law----
    Mr. Crawford.--right now, Administrator.
    Ms. McCarthy. I am sorry.
    Mr. Crawford. In the age of social media and electronic 
communication, it is deeply troubling that agencies are willing 
to use these tools to subvert the concerns of the affected 
public, and drown out opposition to your own views. And it is 
obvious that you were trumpeting your own views, and not taking 
into consideration the public's views, when this is a public 
rulemaking comment period.
    So I don't know how, after all those revelations were made, 
did you expect us to believe that during the WOTUS rulemaking 
the EPA actually took into account all the views by affected 
stakeholders. Or were you just concerned about the views of 
your political allies? It appears to me that that was the case.
    Ms. McCarthy. Sir, the GAO never indicated that we 
referenced a particular rulemaking. They never indicated that 
we said anything incorrect. They had one concern relative to 
Anti-Lobbying, which was a hyperlink to a program that we were 
touting as being really good. One blog from one individual in 
the Agency out of thousands was done, and it referenced a 
hyperlink, and they could not go back and prove or disprove 
whether or not that NGO, at some other place in their webpage, 
may have had an ability for people to contact Congress on other 
related issues or this one.
    We are certainly sensitive to the fact that that hyperlink 
referenced an outside of EPA website. There are other agencies 
that flag that. We are considering and working with OMB on what 
we can do, but if you look at this, there was no intent, and 
there was no lobbying on the part of the Agency, or a 
reference----
    Mr. Crawford. Okay. I think----
    Ms. McCarthy.--to that----
    Mr. Crawford.--then, we can take this as an example and a 
validation of the fact that the rulemaking process is deeply 
flawed, and needs to be addressed, because this kind of stuff, 
to me, is not reflective of the opportunity that should be 
granted to the affected stakeholders. Let me switch gears with 
you quickly in the time I have remaining. I was just told 
yesterday that the EPA took action against a farmer who didn't 
comply with the SPCC rules on on-farm fuel storage by failing 
to have an SPCC plan for his oil storage tank that was 5,000 
gallons in size, but the 2014 WOTUS specifically says that EPA 
can only require compliance for oil storage tanks in excess of 
6,000 gallons until such time as the EPA completes a study, and 
a new rulemaking process is undertaken.
    My understanding is that the study is complete which 
recommends a lower exemption threshold, but the rulemaking is 
still not finished. So my question to you is why is the EPA 
taking enforcement action against individuals who are not out 
of compliance, and isn't that a violation of the law?
    Ms. McCarthy. Sir, I am happy to look into it and get back 
to you. If it just happened yesterday, I am really not familiar 
with it.
    [The information referred to is located on p. 65.]
    Mr. Crawford. Well, is that kind of thing a regular 
practice by the Agency?
    Ms. McCarthy. I think we have actually been doing a very 
good job on the SPCC rules. Many of them, because of changes in 
threshold, like 96 percent of them, are no longer impacted by 
this rule. And of those----
    Mr. Crawford. Okay, let me ask you this----
    Ms. McCarthy.--four percent, 97 percent self-certify. So 
we----
    Mr. Crawford. Do----
    Ms. McCarthy.--we are doing pretty good.
    Mr. Crawford. Right. Do EPA agents take compliance actions 
like this because they know that farmers aren't willing to 
fight enforcement actions because it costs them more in legal 
costs than it would be to just go ahead and succumb to the EPA 
pressure? Am I off base in suggesting that?
    Ms. McCarthy. I don't know why you are suggesting it, sir, 
but if that is your point of view, you can have it.
    Mr. Crawford. It is my point of view, and it is the point 
of view of the----
    Ms. McCarthy. But I don't know anything about this 
enforcement----
    Mr. Crawford.--most of the people in my district who farm 
and are subject to EPA regulation. I yield back.
    The Chairman. The gentleman yields back. Mr. Scott, 5 
minutes.
    Mr. David Scott of Georgia. Thank you, Mr. Chairman. First 
of all, Ms. McCarthy, I think that you, and the EPA, have 
drastically manhandled and violated the rights of our farmers, 
especially dealing with this water issue. You did break the 
law. You did break the law. Now, let me tell you, Ms. McCarthy, 
in Section 15 of the Financial Services and General Government 
Appropriations Act, it expressly prohibits you from lobbying in 
support, or in opposition, to pending legislation or rule. 
Further, not only there did you break the law, but in Section 
401 of the Department of the Interior's Environment and Related 
Agencies Appropriations Act, that is applicable right now, 
prohibited the use of the EPA's appropriations for lobbying. 
You broke the law. It needs to be admitted. It needs to be 
recognized. And, furthermore, you spent taxpayers' money in the 
lobbying. And the GAO reports it is $64,610 that you spent in 
lobbying from February 2014 to 2015. Now, let us come clean 
with this, so we can correct this. There is no way you are 
going to correct this if you don't realize that you have 
drastically overstepped here. And let us get that cleaned up.
    Now, the other part that really gets in my craw is this. I 
was born on a farm, grew up on a farm, and there is a reason 
why farmers go and develop ditches, and ponds, and wells, and 
they are man-made, because that is an insurance policy for the 
drought. Our animals still have to be fed, they have to drink. 
There are many times when it doesn't rain for 4, 5, 6 weeks. 
And that is why we have that. The other point is, this is the 
farmer's private property, and it is not navigable waters. It 
is there for the purpose of being able to give us protection 
when that rain doesn't come. My little farm was a tobacco farm, 
and when you go to the tobacco beds, you have to put the plant 
in, and you have to have the water right there to go in with 
the plant. Suppose it doesn't rain.
    Now, that is on that farmer's property. He shouldn't be 
permitted for his own property. And then he shouldn't be fined, 
the farmer has to pay for a permit on his own property for a 
puddle of water, or a ditch, or a pond, or a well that they 
made themselves so that they could be able to have that 
insurance on a rainy day. And then to violate all of that, the 
law itself, to go and lobby, and spend taxpayers' money on it. 
That is a damnable thing to do to our farmers, who are faced 
with so many other challenges. The EPA needs to reject this 
rule, recognize and admit that it broke the law, and then move 
to correct and say this will never happen again.
    Now, finally, in my last second, I don't want to go over 
time, but I want to raise this issue for our cotton folks on 
the chlorpyrifos. I guess a better way of saying that is 
Lorsban. Anyway, we need this for our cotton producers and for 
our pecan producers. As has been said before, by the Chairman 
and others, our cotton people are going through a very serious 
time economically, and they don't need a doubt of whether or 
not they can use this pesticide. So will you please make sure 
we can use that? And hopefully put this business aside for the 
Clean Water Rule, and let us move forward, and let these 
farmers have some peace of mind.
    Ms. McCarthy. Thank you for your passion, sir.
    The Chairman. The gentleman yields back. Mr. DesJarlais, 5 
minutes.
    Mr. DesJarlais. Thank you, Mr. Chairman. Ms. McCarthy, 
thank you for being here today. Just one follow up on Mr. 
Scott's question. He pointed out that GAO determined that you 
violated Federal law. Who was in charge of the covert 
propaganda and the grassroots lobbying? Who was the person in 
charge of that?
    Ms. McCarthy. It is actually just part of our outreach and 
education, sir. There was no covert propaganda, and there was 
no lobbying.
    Mr. DesJarlais. So there is nobody over that particular 
outreach? There was nobody in charge of that that you are aware 
of?
    Ms. McCarthy. Sure. We have communications folks that have 
been----
    Mr. DesJarlais. Okay.
    Ms. McCarthy.--doing it. This----
    Mr. DesJarlais. Who is the head of that? Who was 
responsible for that?
    Ms. McCarthy. I would have to go back and look at the exact 
time, but we have actually a large education and outreach 
group. But none of that----
    Mr. DesJarlais. Nobody was punished for it, though, right?
    Ms. McCarthy. We don't believe----
    Mr. DesJarlais. I understand that the person that is over 
it is now promoted and working for the White House, but that is 
beside the point. In your opening statement in response to the 
Chairman, you made it sound like Congress is imploring you to 
move forward with this WOTUS. Where did the idea for WOTUS come 
from, and basically who was in charge of drafting this package?
    Ms. McCarthy. Actually, the WOTUS, or the Clean Water Rule, 
came because the Supreme Court told us that we needed to make 
improvements to the law based on science. We needed to prove a 
connection. We needed to do a better job.
    Mr. DesJarlais. That wasn't Congress, like you----
    Ms. McCarthy. So--no, it was----
    Mr. DesJarlais.--said in your opening statement. It wasn't 
us.
    Ms. McCarthy.--followed up--it actually was followed up 
by--Congress asked us to take action to address concerns. 
Individual stakeholders, members of the ag community. 
Absolutely people are looking for us to do a better job than 
the 2008 guidance, and to respond to the concerns and 
criticisms that the----
    Mr. DesJarlais. But you went around Congress and used the 
rulemaking process, correct?
    Ms. McCarthy. No, sir. We were actually asked to do a 
rulemaking for clarification. Whether you disagree with that 
rule or not is fine----
    Mr. DesJarlais. What is the cost of this?
    Ms. McCarthy.--but the EPA didn't generate this on its own.
    Mr. DesJarlais. What is the cost going to be to implement 
this rule?
    Ms. McCarthy. It is actually a net benefit of something in 
the order of $184 million.
    Mr. DesJarlais. A benefit, not a cost? I mean, because I 
have heard it costs anywhere from $180 million up to $500 
million, which that would change the way the rulemaking process 
works, correct? If the cost is over $100 million, you can't go 
around Congress the way you did.
    Ms. McCarthy. No, actually, the $100 million threshold 
means we go through the inter-agency process, which we did.
    Mr. DesJarlais. Yes. Do you know Howard Shelanski?
    Ms. McCarthy. Yes, I do.
    Mr. DesJarlais. Okay. Have you worked with him on this?
    Ms. McCarthy. Yes, I did.
    Mr. DesJarlais. Do you know why he won't give the required 
documents to the Oversight and Government Reform Committee that 
we have been asking for since March 3 of 2015?
    Ms. McCarthy. I am not aware of what you are referring to, 
sir, no.
    Mr. DesJarlais. Okay. We had a hearing about the rulemaking 
process, and the fact that this was a major rule, and we have 
been asking, and actually have had to now subpoena these 
documents for over a year. You don't have any idea why they are 
ignoring our request?
    Ms. McCarthy. I don't know what the situation is.
    Mr. DesJarlais. You have not had any conversations with 
him?
    Ms. McCarthy. No, sir.
    Mr. DesJarlais. Okay. Is this directive more from the White 
House?
    Ms. McCarthy. What directive are you referring to?
    Mr. DesJarlais. The WOTUS ruling itself.
    Ms. McCarthy. No----
    Mr. DesJarlais. The Waters of the U.S. Because it is 
certainly not from Congress. We voted both in the Senate----
    Ms. McCarthy. No----
    Mr. DesJarlais.--and the House to stop it.
    Ms. McCarthy. I just explained to you where the impetus 
came from.
    Mr. DesJarlais. Yes. And the courts have blocked this, 
correct? The implementation.
    Ms. McCarthy. It is being litigated in one District Court, 
and it is now with the 6th Circuit, where they are looking at 
whether or not the District Court has jurisdiction or they do, 
but you are absolutely right, we are now stayed in terms of its 
implementation until those court issues are resolved.
    Mr. DesJarlais. Okay. Well, you act like you are doing us a 
favor, but yet we have 31 states and many agricultural 
organizations filing lawsuits against you. So you don't think 
that maybe there ought to be a reason for pause? Maybe we ought 
to scrap this thing, go back to the drawing board, and do it 
right?
    Ms. McCarthy. We will certainly hear from the courts as to 
whether we met the legal test in terms of its merits.
    Mr. DesJarlais. So why did the EPA decide that it was 
necessary to do this?
    Ms. McCarthy. Because of the lack of clarity, and the 
inconsistency, and the unfairness of the current process.
    Mr. DesJarlais. Okay. But under the Clean Water Act you 
were restricted to navigable waters. Mr. Scott talked about 
farm ponds, stock ponds, where cattle drink out of. Is that a 
navigable water?
    Ms. McCarthy. The actual navigable water, the Supreme Court 
has told us that that goes well beyond what we would 
traditionally think of as navigable, and we have to then 
protect waters that have the ability to significantly impact 
the biological, physical, and chemical integrity of navigable 
waters.
    Mr. DesJarlais. You understand----
    Ms. McCarthy. Does it respond to ditches on farm lands? We 
have done a really good job, if you look at the Clean Water 
Rule, to make sure that we are clarifying the word ditch. That 
is in the Clean Water Rule, not in----
    Mr. DesJarlais. It would take another 10 minutes for you to 
describe what is a ditch and what is not a ditch, but I will 
just end with the fact that America is frustrated right now 
with big government. That is the number one issue with 
Americans----
    Ms. McCarthy. Okay, sir.
    Mr. DesJarlais.--is the overreach of Federal agencies. So I 
would hope that you would withdraw a little bit, take your 
time, and get this right.
    Ms. McCarthy. Thank you, sir.
    Mr. DesJarlais. Thank you for being here.
    The Chairman. The gentleman's time has expired. Ms. Lujan 
Grisham, 5 minutes.
    Ms. Lujan Grisham. Thank you, Mr. Chairman. Administrator, 
as you are aware, on August 5, 2015 the EPA team that was 
investigating the contamination at the Gold King Mine in 
Colorado accidentally released 3 million gallons of waste water 
into the Animus River, which then flowed into the San Juan 
River, which is in New Mexico, part of it, and Lake Powell, and 
I think that you actually estimated that in that accidental 
release there were 880,000 pounds of metal that was deposited 
into the Animus River as a result of the release. Now, while 
the initial plume dissipated within several days, I want to 
alert you, you may already be aware, that there remain very 
serious concerns about the long-term impacts, both 
environmentally and for public health. And I am aware that both 
the State of New Mexico, through primarily their Environment 
Department, but certainly in my communications with the 
Governor, and the Navajo Nation and its President, that they 
have real concerns over a proposed 1 year EPA monitoring plan, 
which doesn't do anything about monitoring groundwater, plants, 
crops, wildlife, and certainly doesn't take into consideration 
continued runoff. I hope we don't have it too soon, but a 
spring runoff, which means that all that sediment gets moved 
again.
    And so I would agree that the state is correct in assessing 
that there needs to be a long-term monitoring impact, that 
there ought to be a plan that involves their independent 
review. They are there. They are familiar. They are aware, 
which I realize is difficult, 20/20 hindsight, we all wish we 
had that. You want that expertise so you don't have these kinds 
of issues, you don't have these kinds of accidents, and that 
you don't have information that may not be accurate, or really 
relevant, to the area in which you are testing.
    Can you talk to me about your conversations with the State 
of New Mexico and the Navajo Nation, and whether you are 
entertaining to support them, and fund them, and give them the 
resources to assure that the public health of the citizens of 
that state are protected?
    Ms. McCarthy. Well, we are certainly going to do just that, 
in a couple of different ways. We know a lot of those states, 
and the Tribes, that were impacted by this spill have been 
discussing with us reimbursement of their expenses, your state 
did a great job at responding to that. We are sitting down with 
them, looking at both a short-term monitoring program and a 
long-term one that doesn't just look at the area of the spill, 
but does a much broader look at the watershed in general. And 
how we cannot just do that with EPA scientists, but they can be 
engaged because they have scientific expertise. And 
universities in your area have great scientific expertise.
    EPA has identified funding for that, and we are going to 
work with them to make sure that we do the monitoring that is 
necessary to understand any impacts in the watershed.
    Ms. Lujan Grisham. Great, because I think that robust 
partnership will bring about credibility. I can't agree with 
you more about that expertise, which leads me to the second 
question I want to ask, which is related to the MS4 watershed 
permits in the Middle Rio Grande. It is a completely separate 
issue, but it includes 15 individual entities and 
jurisdictions. The Middle Rio Grande region is one of three in 
the country that were chosen to pilot a regional watershed 
approach, and it is the only region in the western United 
States to participate. And the problem is, as you are looking 
at all of these water issues, or Clean Water related activities 
you are including requirements that are developed for eastern 
climates. And I don't think that we are using the right 
expertise. And I will tell you that everyone in these affected 
jurisdictions is really struggling in their relationship with 
you, because the aspects of the permit do not make sense in 
arid environments. And they, quite frankly, conflict with all 
of our state water laws, and many of our Federal water laws 
compacts.
    Stormwater regulation needs to have the flexibility to make 
sure that local managers can suggest alternatives that make 
sense for an arid region. Are you aware that we are having 
these conflicts, and do you see a way for us to have much more 
flexibility so we meet your overall goals, and are 
participating productively, but we can do it correctly?
    Ms. McCarthy. Well, all of our water programs, by law and 
by intent, is a partnership between EPA and the states. I did 
not know that there were concerns that had been raised that 
have not yet been resolved in these discussions, and they have 
to be resolved. They have to be resolved in a way that makes 
sense for those communities. And you are absolutely right, 
flexibility is the key to doing that.
    Ms. Lujan Grisham. I am out of time, Mr. Chairman. Thank 
you for your patience again, and we will work with you to get 
this resolved. Thank you, sir.
    Ms. McCarthy. That would be great. Thank you.
    The Chairman. The gentlelady's time has expired. Mr. 
Gibson, 5 minutes.
    Mr. Gibson. Thanks, Mr. Chairman. Ma'am, I represent parts 
of upstate New York, 11 counties, 162 towns. Among those, the 
town of Hoosick. And in Hoosick we have a village, Hoosick 
Falls. It is a very proud area, and for good reason, 
hardworking, good folks. And these are really challenging times 
for Hoosick Falls right now due to a chemical that has been 
detected, PFOA. We have not had potable water in Hoosick Falls 
now for over 6 weeks. We are working on that. We have carbon 
filtration process ongoing. We do think in several weeks we 
will have potable water. And, at the same time, we are not 
monitoring blood levels of the citizens, and we are beginning 
the long process of a comprehensive health study. And we are 
soon to begin the process of identifying the source of 
contamination, and ultimately identifying an aquifer that we 
can be confident in, going forward.
    Ma'am, in March of 2015 we contacted the EPA, and the 
response then was that PFOA was an unregulated chemical, and 
that it did not pose a health risk. At the end of the year, 
specifically on the 17th of December, EPA came out with a 
statement and said that the water is not potable, and, 
furthermore, that it posed a risk to health. And so my question 
is, how do you go about making this determination, and what 
changed from March to December?
    And before you answer that, in my research, as I have 
worked on this, I have come to find out that there are many 
unregulated chemicals. And, ma'am, I think we need a method. We 
are going to have to have a method that we then go through all 
these unregulated chemicals, and have a way, hopefully with 
analytics and automation where we can compress and go through 
all the health data so that we can come to these 
determinations. Because I can tell you, my people, they are 
hurting, and they are very disappointed, and we are looking for 
answers.
    Ms. McCarthy. Well, I share your concerns, and your 
interest in finding ways in which we can more effectively and 
quickly address these new chemicals that are entering into some 
of our water systems, and we are finding across the country. 
Now, I believe that our region has been pretty aggressive in 
working with the community, and I want to thank you, and the 
community, for how quickly people have been reacting to this 
situation, getting bottled water out, getting a new carbon 
system in.
    EPA has been trying very hard to keep up with new chemicals 
that we are finding, to do the science behind that. There is a 
systematic process to do that. That is written into the law and 
the rules, about recommending first, identifying, going through 
a listing process that is public before you can regulate, and 
actually working with the states and local communities to adopt 
those regulations.
    Mr. Gibson. So, ma'am----
    Ms. McCarthy. So it is----
    Mr. Gibson.--just so I----
    Ms. McCarthy.--a long process.
    Mr. Gibson.--understand--I am hearing you. So is that the 
answer to my question, is----
    Ms. McCarthy. No, it is not. That is the preface of how 
difficult it is now, and why I agree with you that we need to 
do better. We are looking at more automation in how we do the 
science around this. But, frankly, if Congress would continue 
their push that they are on in re-upping the Toxic Substances 
Control Act, we would have more ability to understand what 
chemicals are going into products in the system, and what 
challenges they may pose, so that we can be better able, in the 
end, to find out where they are, and what they are doing, and 
the science behind those.
    Mr. Gibson. So from March to December, was there something 
that changed in our understanding of PFOA, or was it just a 
latency in understanding that there was a danger out there? 
This is what I am not clear on.
    Ms. McCarthy. Yes. I will have to go back and talk to the 
region, because I am not sure that I can specifically answer 
your question. I believe that the testing that was provided to 
the region early on was in a system that wasn't currently in 
use. But when we found out that there were existing drinking 
supply wells that were being used, part of the challenge for us 
was that our recommended levels in some cases was fairly high, 
is currently being reconsidered.
    We were trying to give the best information that we had, 
based on the science we knew, and that is why there was 
continued debate back and forth on the level, and what was 
safe, and what wasn't. But that is because the science was 
changing, and the tests were changing, and what we knew to be 
the case, in terms of what people were drinking, was changing 
as well.
    Mr. Gibson. Okay. Ma'am, we will stay in touch on this. Mr. 
Chairman, I am going to have to submit for the record a second 
question that has to do with the Hudson River. And, with that, 
I yield back.
    The Chairman. The gentleman yields back. Ms. Kuster, 5 
minutes.
    Ms. Kuster. Thank you, Mr. Chairman, and thank you to the 
Administrator for being with us today. Always great to have a 
New Englander in our Committee. I will be quick. I have two 
questions. The first one relates to this Waters of the United 
States rule, in conjunction with the EPA regulation on 
pesticides, and the Fish and Wildlife ruling regarding the 
long-eared bat. And my question on behalf of farmers, 
landowners, and timber owners in New Hampshire is how will your 
Agency coordinate with USDA and Fish and Wildlife to minimize 
confusion about the interplay between these three rules? If you 
follow.
    Ms. McCarthy. That is a very good question that I am not 
sure I can answer. I will have to get back to you, because you 
have just baffled me with the bat question, connecting with the 
Clean Water and the other issues I understood.
    [The information referred to is located on p. 66.]
    Ms. Kuster. Yes. I mean----
    Ms. McCarthy. That one threw me----
    Ms. Kuster.--basically, I am trying to get some guidance, 
because I have more trees than people, so it is a big timber 
area. I have farmers, I have landowners working on 
conservation. And as these three rules come together, it is 
obviously going to limit the way they can use their property. 
And I just want to try to get them some guidance, because I 
just wonder if there is coordination. That is basically what I 
am looking at.
    Ms. McCarthy. Well, certainly I haven't been a part of it, 
so I better figure it out.
    Ms. Kuster. That would be great. Thank you. Thank you very 
much.
    Ms. McCarthy. Okay.
    Ms. Kuster. Yes, the bat threw me the first time too, but 
apparently it is an important bat.
    Ms. McCarthy. Well, they all are. They all are.
    Ms. Kuster. And then the second question, this relates to 
the Clean Power Plan, and the biomass energy. I am the co-Chair 
with my Republican colleague, Mr. Westerman, of the Biomass 
Caucus here in the Congress. I understand that the Supreme 
Court issued a stay this week on the Clean Power Plan.
    My question goes beyond the stay. There is confusion in the 
biomass energy world regarding whether or not biomass will be 
treated as a carbon neutral form of energy. We have submitted 
letters to you. I am just curious whether a determination has 
been made, and whether biomass will be treated as carbon 
neutral under the Clean Power Plan.
    Ms. McCarthy. Well, that is a question I understand, so 
thank you. You helped me recover a little bit. Biomass is 
actually a really important part of, and we expect it to be, 
many states' compliance strategies that they would use for the 
Clean Power Plan. And so we know that there have been questions 
raised. The rule itself identifies biomass that we think is 
carbon neutral that would be enormously helpful to consider, 
but we also recognize that there are other things that the 
states are looking for, for guidance.
    So we have actually notified folks that we are going to be 
pulling together a workgroup, and we are doing webinars on this 
to get people up to speed so that we can have the right 
questions, and develop the right answers, for how a state can 
feel confident to have biomass be an effective part of their 
compliance strategy. We are sure it will be, but there are 
uncertainties about what EPA might approve, and we want to make 
sure that we are working with everybody to get that done.
    Ms. Kuster. So I would love to just issue an invitation 
from the Biomass Caucus. We would love to set up an event here 
on the Hill with your team to educate Members of Congress, as I 
say, bipartisan from all over the country, to learn more about 
this interpretation, and then we can help to take that----
    Ms. McCarthy. That would be great. I know that many of your 
Members have prompted this----
    Ms. Kuster. Great.
    Ms. McCarthy.--workshop to happen. Maybe we could do it 
right after, and we can give you a sense of where we are.
    Ms. Kuster. Okay. That would be great. I have to go to 
another committee, but I will have my staff stick around to 
connect with you. Thank you----
    Ms. McCarthy. Thank you.
    Ms. Kuster.--so much. Thanks for being here, and I yield 
back.
    The Chairman. The gentlelady yields back.
    Ms. Kuster. With time to spare.
    The Chairman. I noticed that. Thank you very much. Mr. 
LaMalfa, 5 minutes.
    Mr. LaMalfa. Thank you, Mr. Chairman. Ms. McCarthy, I 
appreciate your attendance here today, and willingness to 
answer all these questions. Just to tag off of something Austin 
Scott talked about a while ago, where there is a great concern 
amongst the racing community, and the car enthusiasts, that you 
have a regulation coming down on basically stock cars that have 
been converted for racing. If you want your outfit to be known 
as the Entertainment Prevention Agency amongst millions of 
racers around the country, I would certainly recommend not 
pursuing that, so please check into that, and----
    Ms. McCarthy. I will, sir----
    Mr. LaMalfa.--let me hear your answer on that.
    Ms. McCarthy. Thank you.
    Mr. LaMalfa. Now, a follow up on something from a couple 
months ago with one of your colleagues too. We have in my 
district something known as Iron Mountain Mine, above Redding, 
California. It is above the Sacramento River, which affects 
water supplies for 20 million Californians, and many, many 
hundreds of thousands of acres of agriculture. Iron Mountain 
Mine's situation wouldn't be that much different than the Gold 
King Mine, and the Animus River situation as well. So I had 
asked for a report a couple months ago from that. So would you 
please see to it that I can get that report so that I know that 
our----
    Ms. McCarthy. Yes, sir.
    Mr. LaMalfa.--situation there is stable on that? Because we 
certainly can't have that affecting that many Californians on 
that mine. So thank you.
    Ms. McCarthy. Sure.
    Mr. LaMalfa. On the issue of Section 404, and the 
exemptions that are provided for agriculture under the Clean 
Water Act, normal farming activities, ranching, forestry, et 
cetera, including repeat plowing, seeding, cultivating, minor 
drainage, harvesting for that production of the food and the 
fiber and forest products, conservation practices, et cetera, 
no additional requirements, for example, that an activity be 
continuous are included.
    Some of my constituents are continuous cropping on these 
lands, otherwise you lose your ability to have that exemption. 
Nowhere in the law does it specify that, but that is what is 
being carried out in my district by EPA or your associates. 
Sometimes we refer to them as henchmen, but in the Army Corps 
of Engineers that are carrying out some very outside the law 
activities with this regulation. So do you agree that section 
404 does make no additional requirements that an activity be a 
continuously cropped, as we see it in the law?
    Ms. McCarthy. I am not aware of it, but I certainly will 
have to get back to you on it, sir.
    [The information referred to is located on p. 66.]
    Mr. LaMalfa. Okay. So continuous cropping activities, we 
feel, are not required under the----
    Ms. McCarthy. And I don't know what actions you are 
referring to, so I should dig into it.
    Mr. LaMalfa. Well, they are coming down hard on people, 
fining them, or making them, in some cases, seek permits to do 
what they have been doing. Or if they just let the land idle 
for a few years, which is good, fallowing the land, and----
    Ms. McCarthy. That is what people do, sure.
    Mr. LaMalfa. Sure. And for market conditions, whatever 
those might be. You shouldn't have to have a new permit--which 
sometimes folks seeking permits are afraid they are going to 
end up with a 3 year waiting process for getting the permit 
issued to them, is the EPA or Army Corps going to pay their 
land payments and tax payments while they sit and wait for 
these decisions?
    I have another one so I have to go fast, I apologize. 
Section 110 of the Consolidated Appropriations Act of 2016 
specifically prohibits funds from this Act for being used to 
require a permit for the regulation. That is what was alluded 
to my colleagues a while ago. Are you aware of that exemption 
under section 404 as well, under that appropriation? It was an 
appropriation amendment that specified no funds are to be used, 
so----
    Ms. McCarthy. For which specific----
    Mr. LaMalfa. It was under Section 110 of the Appropriations 
Act of 2016 that no funds are to be used under Section 404 
requiring these permits.
    Ms. McCarthy. No, I am not aware of it. I will look at it.
    Mr. LaMalfa. Okay. Well, that is a direct law put in place. 
So I will look forward to your answers on that.
    Ms. McCarthy. Thank you.
    Mr. LaMalfa. Again, moving quickly here, EPA and Army Corps 
of Engineers continue to rely upon EPA's interpretation of the 
Clean Water Act, imposing these regulations that stray far from 
the Congressional intent. Again, indeed, you mentioned several 
times following the law. It is pretty clear in the law and the 
exemptions, and then follow up by these amendments and the 
Appropriation Act that we have done here. So we believe that we 
are the ones that set that course there, and that the EPA is to 
follow it.
    So as long as they have exceptions to the exemptions, and 
that is where it is very problematic. There are exemptions on 
that, but if the EPA is looking for exceptions to exemptions in 
your rulemaking, then who is making the law here? That is what 
a lot of people are really concerned about, is that we are not 
the lawmakers anymore. Will you direct your Agency to cease 
regulating activities that the Clean Water Act exempts?
    Ms. McCarthy. We should not be doing anything other than 
exempting those activities.
    Mr. LaMalfa. Okay. Thank you. My time has expired. I will 
have some follow up questions. I appreciate, again, your 
answers today.
    The Chairman. The gentleman's time has expired. Mrs. 
Walorski, 5 minutes.
    Mrs. Walorski. Thank you, Mr. Chairman. And, Administrator, 
thanks so much. I am over here. I said hello earlier, and I 
again wanted to invite you to northern Indiana, to my district, 
for a couple of reasons. So I have sat here, and you have too, 
for 2 hours, and here is the issue in my district. In northern 
Indiana, who I represent, we have one of the largest 
manufacturing districts in the country, not just the Midwest. 
In the southern part of the state, we have coal mines, and we 
are strewn throughout with ag, heavy agriculture, as well.
    And so, I look at this, and I have said since the day I 
came to Congress, and even prior, Indiana is a good role model 
for being good stewards of the environment, being good stewards 
of the economy. And I could show you in my district places 
where we are really out of the box, and we are doing things 
that are incredibly creative to be such good stewards of the 
environment. But nobody is a better steward of the environment 
than the family farmer, because their complete livelihood 
depends on taking care of that area. So I do agricultural tours 
every single time I am in the district, and on the last 
agricultural tour, we have been able to diversify. We have been 
able to do great things in our state. We have been able to do 
some really clean water, things that are exemplary.
    When I came away from there--and I am old enough to 
remember when the EPA was really considered a partner with 
industry, a partner with farmers, and really kind of came 
alongside, especially in our state. We have an incredible 
Indiana Department of Environmental Management that comes 
alongside. Not to be punitive, not to penalize, but to 
incentivize, and to keep people from really getting in trouble. 
I came away from this agricultural tour really having an 
understanding that, in my mind, what I heard from my farmers, 
is that today's EPA has become a punitive revenue generator for 
big government.
    And it bothers me, because I sit on this Committee, and I 
know there are a lot of well intentions, but when it comes to 
this WOTUS rule, and I understand exactly why the frustration 
is so high in this room on both sides. This is not a partisan 
issue today. This is an issue of Americans, and farmers, and 
Members that represent them trying to come to grips with an 
understanding, in a state like Indiana, we are in a target 
virtually in every single portion of what we do and what we 
lead our nation in, in coal, in ag, and in heavy manufacturing. 
The toll on jobs because of this issue of heavy handed 
government; there is really no other way to explain it. I 
understand your intention, but I also understand that I have 
been around long enough that we have been able to have great 
gains in this country with a partner in the EPA.
    And when we talked about humility, and we talked about 
attitude, there is a gigantic tone problem. When I come out of 
my district hearing from people from all over the state saying, 
it is a punitive regulating system, and when EPA comes calling, 
we don't even have chance to even implement rule number one, 
and here comes implementation of rule number two. And I am 
curious, especially on WOTUS, because I agree with my 
colleagues here. I would ask you to pull this rule and bring 
stakeholders around this, and let us do it right. Let us do it 
balanced. I am not calling for one extreme or the other. I 
believe there is a balance between good stewards of the 
economy, and I can tell you that my state does that.
    But my question is this. So when we talk, on one hand you 
say the EPA doesn't intend to regulate every ditch. On the 
other hand, we look at actual implementation of the rule. The 
ditch exemption appears to leave some room. So here is my 
question. So is the ditch exemption automatically given if a 
business, farmer, or local government believes it is exempt, or 
do they have to prove it is exempt?
    Ms. McCarthy. The way in which the law works is that, if 
there is a question that you are going to be destroying or 
polluting what might be a water----
    Mrs. Walorski. A question from the EPA?
    Ms. McCarthy. No. That would be the individual landowner 
might be concerned that their activity would be doing that, and 
they may be----
    Mrs. Walorski. On their private land?
    Ms. McCarthy. On their private land or elsewhere----
    Mrs. Walorski. Yes.
    Ms. McCarthy.--then that question is raised by that 
landowner, and they ask the appropriate questions. That usually 
and often goes to USDA or others, and filters its way through. 
But we are not changing the dynamic of how the rule or how the 
guidance was implemented----
    Mrs. Walorski. Yes, but let us just say worst case 
scenario. Worst case scenario, some farmer ends up with 
somebody, somehow, says that he is not in compliance, and he 
must do X, Y, Z. Would the Waters of the U.S. Rule, as it is 
now, and what we are talking about with this exemption, could a 
farmer potentially face any kind of legal action if he was 
strongly on the side that he is not out of compliance, and 
somebody from EPA comes in and says, you are? If this goes all 
the way to the end, could somebody, like a farmer, be 
penalized, and face legal action, and have to defend himself on 
a question of water on his own land?
    Ms. McCarthy. There have been enforcement cases. There have 
not been a great deal, compared to the way in which people get 
to work together to answer these questions, and to get permits 
done. I will honestly tell you, in my heart of hearts, we 
worked very hard on this rule to make the clarity you need so 
that you, as a farmer, can actually be assured that if someone 
asks that question, you know the answer.
    Mrs. Walorski. Yes, I know. In all honesty, you missed the 
mark, and I would again ask that this rule be repealed, and we 
go back and----
    Ms. McCarthy. Right.
    Mrs. Walorski.--allowed to come to the table. Thank you, 
Mr. Chairman.
    Ms. McCarthy. I appreciate it.
    Mrs. Walorski. Sorry for the extra time.
    The Chairman. The gentlelady's time has expired. Mr. 
Abraham, 5 minutes.
    Mr. Abraham. Thank you, Mr. Chairman. Thank you, 
Administrator McCarthy, for being here. I will echo, certainly, 
the bipartisan support you have seen here, that our farmers, 
ranchers, foresters, aquaculture farmers, they are their own 
best stewards of their property. They are not going to do 
anything to harm their livelihood, but, more importantly, 
nothing to harm their children and their family.
    To Mr. Austin Scott's reference of asking you the price of 
cotton, I won't put you on the spot and ask you the planting 
season of cotton, or corn, or soybeans, or anything like that. 
But it lends to the question: I am fearful that the EPA, as a 
bureaucracy, wants to literally drive the car, but doesn't know 
how to start the car. And when you don't know the basic facts 
of growing times, when you apply pesticide, and how important 
those windows are to maintain agricultural integrity, then it 
begs the question of who should know these answers? And my 
answer to myself is you should know.
    We talked about pesticides, so I am going to go to my 
questions here, and with respect to your Agency's roles in 
reviewing and approving the use of pesticide, does the EPA 
examine the health and safety of an herbicide under the Federal 
Insecticide, Fungicide, Rodenticide Act any differently if its 
proposed use is tied to a genetically engineered plant versus 
if it is not? And does the Agency meet its registration 
obligation equally in both cases? So I guess my question, is it 
common for products tied to GE plants to be at your Agency 
several years while registration dates are renegotiated 
multiple times?
    Ms. McCarthy. My understanding is that we have had a great 
deal of success in eliminating extensions of time overall for 
all of our program. Actually, quite remarkably. We are mostly 
keeping to those windows. Are there additional challenges with 
genetically engineered products? If they are, then that is 
where the science comes in, and we explore it. They are not 
treated differently than looking at how we always look at 
pesticides, which is by the science, trying to stick with the 
legal timelines in windows that we have to make our decisions.
    Mr. Abraham. And I will follow up with a question on the 
science issue. The President has stressed the importance and 
the value of transparency, and EPA's actions to ensure the use 
of sound science and reliable data. EPA is increasingly reliant 
on epidemiological and modeling data, looking at the 
occurrences, correlations, and extremely unlikely scenarios to 
essentially overrule volumes of actual hard science, laboratory 
and monitoring data, historically relied on around the world 
for decades. Why was this fundamental change in policy not put 
out for public notice and comment so that impacted stakeholders 
would have an opportunity to comment on this transition to such 
a heavy reliance on just the worst case scenario presumptions, 
modeling, studies?
    Ms. McCarthy. I am not aware that there has been any change 
in policy direction, sir, so I am happy to look at the specific 
decision that you are referring to.
    Mr. Abraham. I will look forward to that answer, because I 
am under the understanding that there has been quite a 
transition away from the hard science in looking at----
    Ms. McCarthy. So I am happy to answer it, if that is a 
concern.
    Mr. Abraham. And my last question: let us keep dealing with 
this raw data, this hard science. I have heard about serious 
matters regarding EPA policies based on human research data 
that may not be reliable. For years EPA has relied on hundreds 
of quality studies, evaluating all aspects of human 
susceptibility to pesticides. These included studies designed 
to make sure that children would be protected, and certainly we 
want that. Even though EPA uses those high quality assessments 
for 20 years, EPA now relies primarily on epidemiology studies, 
and some journal articles in which EPA has never, I am told, 
again, seen the raw data to determine if these studies are 
reliable or accurate. Case in point, I am told that Columbia 
University, who conducted a key study, refused to provide the 
raw data to EPA, even though EPA partially funded the study.
    EPA has likely relied on information based on raw data that 
cannot be reviewed for accuracy. And I am running out of time, 
and I will submit this question, is it correct that the EPA has 
not gotten access to that raw data, or are you simply refusing 
to disclose them? And if you have the information, why are you 
not disclosing that information for the public to review? And I 
will look forward to your answers to that question. I yield 
back, Mr. Chairman.
    The Chairman. The gentleman yields back. Mr. Newhouse, 5 
minutes.
    Mr. Newhouse. Thank you, Mr. Chairman. Administrator 
McCarthy, thank you for being here. Let me start by calling 
your attention to a letter I sent to you last month in regard 
to a company called Omak Wood Products. It is Omak, Washington, 
Okanogan County. As you know, we have had, the last 2 years, 
record setting catastrophic fires, wildfires.
    Ms. McCarthy. Yes.
    Mr. Newhouse. It has had a tremendously negative impact on 
our communities. This Omak Wood Products Company is one of the 
largest employers in this small community. I think over 185 
people work at the mill, $60 million impact to the community. 
Unfortunately, they have announced recently that they plan to 
shut down at the end of February. The people in the City of 
Omak are working very, very hard to find someone to come in and 
take over the mill. One of the issues, though, is they don't 
have an operating permit. Two years ago EPA promised a re-write 
of the permit that would more accurately reflect the operations 
at the plant. And I can tell you, without that permit, they are 
having a very difficult time finding anybody interested in 
reopening the plant. So if you could look into that, I would 
very much appreciate your attention.
    Ms. McCarthy. I would be happy to do that.
    Mr. Newhouse. I have a copy of that letter. It is submitted 
for the record, but I can give you another copy, if you----
    [The information referred to is located on p. 65.]
    Ms. McCarthy. That would be great. Thank you.
    Mr. Newhouse. I have a couple of questions, Administrator. 
Section 303 of the Clean Water Act clearly gives the states the 
authority to develop water quality standards and then submit 
those plans to you to confirm that they comply with the CWA.
    Ms. McCarthy. That is correct.
    Mr. Newhouse. I don't think Section 303 gives EPA power, 
though, to establish those criteria for the state, and last 
year EPA indicated it would reject the State of Washington's 
water quality standards on the basis of two things. First, that 
it doesn't account for the consumption of 175 grams of fish per 
day which, I might add, is the equivalent of eating 38 cans of 
tuna a month. And second, for people who actually consume that 
much fish, it doesn't account for the cancer risk level of 
10-\6\, or 1/
1,000,000. So I 
am concerned that your Agency's proposed rule is significantly 
more stringent than required to protect human health, it is 
inconsistent with existing policy, and could cost my state 
billions of dollars for compliance. Could you discuss for me 
just real briefly, I know we have a short amount of time on how 
EPA arrived at these levels, and explain why your Agency is 
seeking to impose standards that far exceed your own water 
quality guidelines for states?
    Ms. McCarthy. Well, I am very familiar with this issue, in 
terms of work that is going on between the State of Washington 
and EPA, where the State of Washington has recently proposed 
water quality standards. We have been starting a process to do 
that ourselves. We are perfectly happy to defer to the state on 
their water quality standard, should those come out in a way 
that we think does two things, is safe for human health, as 
well as protect the Tribal treaty rights which we are obligated 
to protect, under treaty law.
    Mr. Newhouse. Okay. Well, let me follow up, then, real 
quickly. For your proposed cancer risk level, in order to have 
a 10-\6\ you would need to reduce some of the agents 
on the EPA's toxic pollutant list to get this less than the 
naturally occurring levels. That means that the river, as it 
flows naturally, would not meet the levels.
    A 2013 study conducted by Washington State industries, 
counties, and municipalities found that even the most advanced 
technology available, and with billions of dollars in upgraded 
resources, few facilities would be able to meet those 
standards. So my question is, where does EPA think it derives 
the authority and the power to tell states they have to meet 
these standards that they have no part in formulating, and, 
number two, are in no way grounded in sound science?
    Ms. McCarthy. Well, we can certainly have this 
conversation, because I know we are running out of time, but I 
will assure you that the region working on this, our Region 10, 
is in close contact with Washington and stakeholders in the 
business community there to understand how we can come to a 
conclusion, either through the state effort or our own, to be 
reasonable, rational, make sure we have standards that can be 
achieved, and that no way take away the flexibility that states 
have in terms of how they achieve it.
    Mr. Newhouse. I appreciate that answer. I do have more 
questions, but I will have to submit them for the record. 
Again, thank you for being here.
    Ms. McCarthy. Thank you.
    The Chairman. The gentleman yields----
    Mr. Newhouse. Thank you, Mr. Chairman.
    The Chairman.--back. Mr. Kelly, for 5 minutes.
    Mr. Kelly. Thank you, Mr. Chairman, and thank you, 
Administrator, for being here. My first question is: 3 years 
ago Mississippi farmers and beekeepers created a Mississippi 
Bee Stewardship Program to enhance cooperation and 
communication between beekeepers and pesticide applicators. 
This has increased not just goodwill between these two groups, 
but we expect to find that this has increased pollinator health 
as well.
    Unfortunately, despite the good work that Mississippi is 
doing, the EPA is undermining those relationships. While both 
our farmers and beekeepers thought they had addressed many of 
their pollinator and pesticide issues, farmers in my state are 
losing access to key products, and will be unable to protect 
their crops from pests, threatening their livelihood. 
Additionally, beekeepers have concerns that an economic hit to 
the farmers would mean that they would be unable to host bees 
on their farms. Please explain to me what EPA is doing to 
ensure that my constituents will have the time proven products 
and the new effective products available to meet their needs.
    Ms. McCarthy. Well, one of the things we should really talk 
about where this concern is coming from, because I know, in 
working through the pollinator strategy, we recognize that one 
of the key things that needed to be done is an agreement and an 
understanding between beekeepers and their own farmers about 
how to protect those pollinators, while at the same time 
allowing those crops to be properly managed. So if there is a 
disconnect there, I would really love to understand that, 
because it was one of the highlights that said the Federal 
Government doesn't need to get involved in this, as long as 
that communication is working and happening. And so if we have 
missed the boat, I would really love to be able to work with 
you on it to figure out how we might turn that around.
    Mr. Kelly. And I will. I will make sure that we get you 
that information so you understand, because they actually 
started before you asked them to and now they feel like they 
are----
    Ms. McCarthy. Exactly. This is the conversation we wanted 
to have happened.
    Mr. Kelly. Okay. I was going to joke about our accents, 
because I didn't know if we needed an interpreter or not, 
because we speak a little different English.
    Ms. McCarthy. I can understand you.
    Mr. Kelly. But after the hearing today, I am not sure that 
we are not different in more ways than just our accent. And one 
of the smartest terms I heard today was regulatory humility.
    Ms. McCarthy. Yes.
    Mr. Kelly. And I can tell you, I have not seen that 
displayed. And, if you look back, you have 32 states who have 
filed a lawsuit over WOTUS. I think you have both the House and 
the Senate who the majority of Members, regardless of which 
party, think it is not being implemented correctly. I think you 
have courts that are saying that it is not being implemented 
correctly. And what I see is the EPA sticking a flag in and 
saying, we are right, and the rest of America is wrong. We are 
right, and we will defend--and I have heard several times you 
say, we defend this action. I don't agree with what the court 
said on that. I don't agree with GAO that we broke the law. I 
don't agree with this. We will defend our science, we will do 
this. That is not humility. That is the opposite of that. That 
is arrogance. I am smarter than you, I don't care how many of 
you are, and how many different backgrounds you come from, but 
I am smarter than you, and I am right, and you are wrong. And a 
Member asked you earlier, repeal WOTUS. Do away with it. It is 
not that it is a bad idea, but the rule that we have now, I can 
tell you that the majority of America does not believe protects 
them, and they believe it is punitive, and not helpful. We need 
clean water. No one understands that more than me.
    One of the most crucial resources we have in America is 
clean drinking water, is water to water our crops. We all want 
the same thing. But the rule that we have now does not 
accomplish that. But we are so entrenched that we have to have 
this rule. And if you would repeal the rule, step back, get 
with Congress, get with farmers, get with environmentalists, 
get a whole group of people in a room and say, what do we want 
to achieve, and what is the most effective way to do that? And 
let us all take our pride out of it, because we are all 
prideful, regardless of what we are. But to get back to the 
humility, and get the smart people in the room, get a group or 
a commission together, and let us come out with a WOTUS that 
works. Because I can tell you, businesses, farmers, 
legislatures, courts, everyone right now knows that this WOTUS 
rule that we have is not the right rule. Let us quit sticking a 
flag in the ground and defending something that doesn't work, 
and let us come up with something that does protect our clean 
drinking water. And, Mr. Chairman, I yield back.
    The Chairman. The gentleman yields back. Mr. Goodlatte, 5 
minutes.
    Mr. Goodlatte. Thank you, Mr. Chairman, and welcome, 
Administrator McCarthy. I want to go back further than WOTUS 
and talk about the EPA's Chesapeake Bay TMDL scheme, because 
that really is the precursor to what is going on nationwide 
with WOTUS. I think that you would agree that the Bay TMDL is 
both significant and unique for a variety of reasons. In fact, 
early in the implementation process, EPA documents mentioned 
that many specifics of the Bay TMDL were novel in comparison to 
past EPA TMDLs, and that this blueprint could serve as a 
template for other watersheds throughout the nation. Further, 
the concerns voiced by agriculture, forestry, and home building 
industries, in addition some local communities, and to the 
TMDL's numerous legal challenges, speak to the enormous impact 
that the EPA's actions have had, and will continue to have, in 
the Bay region. Given this, shouldn't the EPA have conducted an 
analysis to estimate the cost of such an important rule?
    Ms. McCarthy. It is my understanding that we have been in 
that process of----
    Mr. Goodlatte. Since 2009, and you are almost to the 
halfway assessment point, and you have implemented this 
process, but have never done a cost-benefit analysis to 
determine whether the cost of this to all of these parties 
isn't--and the taxpayers of my district, and all the other 
districts in these six states isn't greater than the benefits 
to the Bay?
    Ms. McCarthy. Well, sir, what we tried to do was to allow 
states the flexibility to choose their own paths forward. And, 
because of that, it would have been extraordinarily difficult 
to provide any certainty about what that cost might be----
    Mr. Goodlatte. That is actually not what happened, if I 
may, because the states have, for the past quarter century, 
done just that. And in fact, that is what the Clean Water Act 
provides for. It says that the Federal Government gets to set 
the standard, and the states get to write the plan, and 
implement the plan to meet the standard. And a lot of progress 
was made over those 25 years. Sedimentation has been reduced in 
the Bay by more than 50 percent, nitrogen and phosphorous by 
more than 40 percent, before this TMDL ever even began. And yet 
the EPA said, that is not good enough, and went ahead with 
putting pressure on the states, threatening the states that if 
they didn't change the way they did it, that there would be 
costs and other consequences to them.
    So, in fact, up until March of 2009, your Agency had 
assured us that no TMDL would be implemented before there was 
an economic analysis. So how much has your TMDL cost the 
affected states, and on average, how much has the TMDL cost the 
average farmer or producer in the Chesapeake Bay Watershed?
    Ms. McCarthy. I can't answer that question yet.
    Mr. Goodlatte. I know you can't, because you never did the 
homework. You never did the work necessary to prove that this 
was a worthwhile undertaking. The Commonwealth of Virginia 
estimated that the cost just to Virginia alone would be more 
than $16 billion. But the EPA never came back and said, ``Well, 
here is a calculation of the added benefits, benefits beyond 
what was already taking place.'' The Chesapeake Bay is getting 
healthier, has been getting healthier for many, many years. 
That is a good thing. We all support that. But when you take 
the law into your own hands, and do it contrary to what the 
Clean Water Act provides, you get lawsuits, rather than 
progress.
    Your Agency has been implementing the TMDL for several 
years now, and, in fact, I understand that next year you will 
be releasing the Chesapeake Bay TMDL midpoint assessment.
    Therefore it would seem that you would have had ample time 
to conduct such an analysis of the cost and the benefits of it. 
Why did you not conduct an economic analysis prior to 
implementation, or at least at some point in the last few 
years?
    Ms. McCarthy. Sir, we are in the midst of that process. I 
do not know when it will be completed. My understanding is that 
it is being worked on by the Agency.
    Mr. Goodlatte. You may well be well past the midpoint 
assessment before you ever determine whether this should have 
been done in the first place. And, therefore, all of the costs 
that have gone forward, if they were not justified, then the 
EPA should not have issued regulations without having that done 
first. Does the EPA not view the financial impact of the rules 
it inflicts upon America's farmers, and homeowners, and 
taxpayers, and small communities that dot the Shenandoah Valley 
in my district, do you not view that financial impact to be of 
importance?
    Ms. McCarthy. One of the reasons why we are doing the TMDL 
the way we are is to allow not just us to consider the most 
cost effective paths forward, but allow the communities 
themselves.
    Mr. Goodlatte. Mr. Chairman, my time has expired, but I 
really have to express my ongoing dismay that this Agency, for 
all these many years that we have been talking about this, have 
received just that, talk, and no information that would justify 
this major impact on these six states, which have, quite 
frankly, the guinea pigs for the rest of the country, which is 
now facing a similar assault under WOTUS, and why both of those 
measures are now before our courts. Thank you, Mr. Chairman.
    The Chairman. The gentleman's time has expired. Mr. 
Moolenaar, 5 minutes.
    Mr. Moolenaar. Thank you, Mr. Chairman. Administrator 
McCarthy, thanks for being here with us today.
    Ms. McCarthy. Thank you.
    Mr. Moolenaar. I am from Michigan, and am neighboring 
Genesee County, and would like to talk with you about the Flint 
water situation. And, as of yesterday, there were some concerns 
raised by a family in Flint, and you may have heard these 
concerns, but their point was: Melissa Mays, as reported in the 
Detroit Free Press, said that we saw more information on Google 
than we did from the EPA. We asked them for help, and got 
nothing. And I guess what I would like to ask is have you been 
to Flint.
    You were there, I believe, on February 2, and really put 
the focus of blame on the state. And the Governor has 
apologized, people have lost their jobs in the state over this 
matter. The EPA Region 5 Administrator, Susan Hedman, resigned. 
Was that over the Flint water situation?
    Ms. McCarthy. Her explanation to me was that it was because 
she knew that she had already become a focus of attention, and 
she thought the entire focus should be on what we do for the 
people of Flint. It was a courageous act on her part.
    Mr. Moolenaar. Do you still maintain, as you did when you 
came to Flint, that the EPA did everything right?
    Ms. McCarthy. I did not maintain that. What I said was that 
a situation like Flint should never have happened.
    Mr. Moolenaar. Right.
    Ms. McCarthy. I explained what I thought were inadequacies 
of the state oversight and primacy. They are the ones that have 
the authority under the law, and they are the ones with the 
primary obligation. But I in no way said that EPA had done some 
kind of thorough analysis of what else we could have, or should 
have, done.
    Mr. Moolenaar. Well, let us just analyze it for a minute 
here, because my understanding is the EPA was aware as of 
February of last year that corrosion controls that would have 
prevented lead from leeching from the pipes were not being 
implemented, that there were serious concerns about raised 
levels of lead. In fact, above the enforcement action level of 
the EPA.
    EPA was aware of that, and did nothing. And we are almost a 
year later, and the EPA did nothing. Can you explain to me why 
that happened?
    Ms. McCarthy. Well, I would say that, I believe, in April 
of last year was when the state actually told us, and corrected 
a misimpression they gave us, that corrosion control was not 
happening. EPA vigorously, from that point forward, recommended 
to the state that they take action to get corrosion control up 
and running. Were there other things that we could have done, 
or should have done? That is the focus of our attention at this 
point.
    Mr. Moolenaar. If I could----
    Ms. McCarthy. But we did oversee this and recommend the 
appropriate steps for the state to take.
    Mr. Moolenaar. Okay. So you are saying that was in April?
    Ms. McCarthy. I believe so.
    Mr. Moolenaar. My understanding is that on February 25 a 
resident from Flint, Ms. Walters, who had four children who 
have lead poisoning----
    Ms. McCarthy. Right.
    Mr. Moolenaar.--contacted Miguel Del Toro, a manager at 
your EPA----
    Ms. McCarthy. Yes.
    Mr. Moolenaar.--Midwest Water Division, informing him that 
Flint is not treating water with standard corrosion controls 
that prevent lead pipes from leeching lead. Also, Del Toro, 
your employee, learned that the taps were being pre-flushed for 
several minutes prior to sampling when they did water tests on 
this. So that is February 25. The EPA has been notified that 
the corrosion controls are not being implemented, and that the 
testing process is flawed.
    Now, my understanding is, under the Safe Drinking Water 
Act, you have the authority for action authorized when there is 
imminent and substantial endangerment to health. And so my 
question is, if you knew this in February, why was there no 
action taken for almost a year?
    Ms. McCarthy. Well, my understanding in February was that 
we did ask the State of Michigan whether or not corrosion 
control was happening. They gave us an indication that it was. 
We relied on that, but at the same time, we did work 
specifically to test Ms. Walters's home, and it is not unusual, 
nor is it an indication of corrosion control happening or not, 
to have a high lead level in a particular home. That can occur 
for a variety of reasons, including a disruption in the street. 
So one house does not dictate whether corrosion control is 
happening and effective. But in no way did Miguel ignore this 
individual's circumstance----
    Mr. Moolenaar. And believe me, I am not saying----
    Ms. McCarthy.--or contact the state.
    Mr. Moolenaar. I am not saying Miguel did it. I am saying 
the upper levels of the EPA did, and that is where I am, 
because Miguel actually e-mailed colleagues at the EPA, 
relaying his concerns about this faulty testing mechanism. And 
also, in follow up tests, when they actually used the right 
testing mechanism, there were lead levels of nearly 400 parts 
per billion, 27 times the EPA's threshold. That is March 3, 
again, almost a year ago, and still nothing happened.
    Now, I want to go again to June 24, again, when Mr. Del 
Toro wrote to the head of the EPA's Drinking Water Division, 
calling Flint's lack of corrosion controls a major concern. 
Again, no action from the EPA. Finally, I am told, that, rather 
than taking action, a legal opinion was requested on the 
authority of the EPA to step in, I have to believe that anyone 
who looks at the documentation of the law would be able to give 
the opinion that the EPA has authority in this matter. Wouldn't 
you agree with that?
    Ms. McCarthy. Well, when you say no action was taken by 
EPA, you minimize the communication that EPA had that we 
normally have with states, that are very clear that corrosion 
controls should have been done from day one, and it needed to 
continue.
    Mr. Moolenaar. If you----
    Ms. McCarthy. It was the State of Michigan that was 
challenging whether or not additional testing was necessary to 
make that determination.
    Mr. Moolenaar. And people have lost their jobs over that. 
Now the question is, if you knew that it wasn't happening, why 
did you not take action?
    Ms. McCarthy. I can explain to you my interaction with 
that, but it is a much longer conversation----
    Mr. Moolenaar. Well----
    Ms. McCarthy.--than that. We clearly did everything we 
could to get the State of Michigan to do what they were 
supposed to do. When I became aware and engaged, that is when 
you saw an enforcement action taken.
    Mr. Moolenaar. And my understanding is the communications 
between the EPA Region 5 regarding this matter have been 
requested. The Governor has released all of his communications. 
When can we expect to see the documentation on the 
communications from Region 5 EPA?
    Ms. McCarthy. We have numerous FOIA requests that are in--
--
    Mr. Moolenaar. But this is pretty important.
    Ms. McCarthy. There is nothing actually more important 
right now than getting that city clean water. And you will see 
a large Federal presence, including EPA, who is responsible to 
get that done.
    Mr. Moolenaar. Okay. Well, when----
    The Chairman. John, you are well over.
    Mr. Moolenaar. Thank you, Mr. Chairman.
    Ms. McCarthy. But I will respond, sir.
    Mr. Moolenaar. Well, I would like to know when you are 
going to have those documents public, I guess is the question.
    Ms. McCarthy. Okay. I will be happy to take that back. We 
have a number of requests. I don't know what the schedule is.
    The Chairman. The gentleman's time has expired.
    Mr. Moolenaar. Thank you, Mr. Chairman.
    The Chairman. Mr. Davis, 5 minutes.
    Mr. Davis. Thank you, Mr. Chairman. Administrator McCarthy, 
thanks for being here. Did your staff prepare for a question 
from me about individual septic systems being included in the 
definition of a sewage treatment facility in the WOTUS rule?
    Ms. McCarthy. No.
    Mr. Davis. They did not?
    Ms. McCarthy. Should I slap them?
    Mr. Davis. Yes. I believe last time, at a Transportation 
and Infrastructure Committee hearing, I said they should be 
fired if they didn't do it, because this would be my fourth 
time. Do you believe individual septic systems are included in 
the language that says sewage treatment facilities should be 
exempt from the WOTUS clarification?
    Ms. McCarthy. I am not familiar with the issue, sir, so I 
don't want to venture a yes or no answer.
    Mr. Davis. I will remind you, at a joint hearing between 
the House and the Senate on Transportation and Infrastructure, 
I did ask you the same question----
    Ms. McCarthy. Really?
    Mr. Davis.--and your response was that we don't regulate 
individual septic system discharge for non-source point 
pollution. But you do, and I still have yet to have my question 
answered if they would be considered under the sewage treatment 
facility exemption under the existing WOTUS rule. I don't have 
a lot of time left. I have some other issues I want to get to.
    Ms. McCarthy. Sorry. I am sorry, go ahead.
    Mr. Davis. That is okay. I will get back to you, and I will 
give you guys another chance at the next hearing. But I am 
disappointed that your staff once again did not have a prepared 
answer on this, knowing that I was going to ask for the fourth 
time. That just makes me, as a Member of Congress, feel as 
though this is more of a check the box issue for the EPA, and 
those who work with, and----
    Ms. McCarthy. I wouldn't want----
    Mr. Davis.--I am sorry that they did not prepare you for 
that. But I----
    Ms. McCarthy. I have great respect, and I would not want 
you to think that.
    Mr. Davis. I, as a former staffer, would not put you in a 
situation like that again. This is very disappointing to us, 
and I am disappointed in those that are sitting behind you. I 
do want to ask you, I know you mentioned earlier in the 
hearing, that you are trying to ensure that there is a better 
working relationship between the ag sector and the EPA. There 
are a lot of folks that don't think that the EPA actually 
accounts for the economic consequences of some of your 
regulatory proposals. I also asked you at our last hearing we 
had whether or not you have worked with the USDA to appoint a 
member of agriculture to the EPA Science Advisory Board. That 
was my language in the farm bill that I offered 2 years ago. 
What is the status of getting that person appointed?
    Ms. McCarthy. On the standing committee?
    Mr. Davis. Yes.
    Ms. McCarthy. Yes. We actually, as recently as last week, 
met with USDA so we can finalize that standing committee. We 
understand how important it is, and we have been working hard 
to make sure that we respect people's interest in getting the 
right applicant pool, and we will be working with USDA on those 
choices.
    Mr. Davis. I appreciate that. It has been 2 years since the 
passage of the farm bill. This is something that I asked you 
about before.
    Ms. McCarthy. That I am aware of.
    Mr. Davis. I just don't think the EPA's actions, again, I 
don't expect you to take away from every hearing our concerns, 
but I do expect the folks who are sitting behind you to follow 
up. And my legislative intent was to get somebody from 
agriculture to work with you so that maybe, when you came here 
today, you wouldn't have had to talk about how you are going to 
work to bridge that relationship, to bridge that gap with our 
agricultural community. It is very disappointing.
    And you can wonder why our ag sector, when it has taken 2 
years for a simple request to appoint somebody from agriculture 
to a standing advisory board, has not been done, why they don't 
trust the EPA. It is very, very disappointing on my end. I 
would hope that by the next time we meet, and I know we will, 
that we could see much more progress on this. Two years has 
been long enough, and agriculture deserves that attention that 
you mentioned you want to give it.
    Ms. McCarthy. Yes.
    Mr. Davis. You would prove it a lot by accomplishing this 
and getting somebody in ag on that science advisory committee. 
So, with that, I want to make my Chairman very happy by 
yielding back the remainder of my time.
    The Chairman. The gentleman yields back. Mr. Yoho, 5 
minutes.
    Ms. McCarthy. Thank you.
    Mr. Yoho. Thank you, Mr. Chairman, I appreciate it. Ma'am, 
thank you for being here. First, I thank you for your Agency's 
work and continued efforts in combating citrus greening in my 
State of Florida. Experts believe that over 70 percent of our 
groves are infected, and we have seen a dramatic decrease in 
production. USDA estimates this season's harvest to be 69 
million boxes, and that is the smallest crop we have had in 50 
years. That is down from the 240 million boxes. Could you speak 
to what your Agency is doing to help the situation? I know you 
guys are doing good work on that. Is there anything that you 
need from us to help facilitate that?
    Ms. McCarthy. Sir, we are taking this situation 
extraordinarily seriously, as you indicate that it is. And I 
know that we met with the Florida Senate and House delegations 
to talk about what we have already done on our recent 
registrations to bring more tools to the table, but we are also 
in the middle of looking at an emergency exemption request that 
will look at the potential to authorize use of antibiotics. And 
we are working with both CDC and FDA, which is the process for 
that, and we are going to try to get that done as soon as 
possible.
    Mr. Yoho. I appreciate that. And if we can help facilitate 
that, or extrapolate work from other crops, whether it is the 
apples, or the grapefruits, or any of that, our state, and 
those people that love oranges, would be greatly appreciative.
    Ms. McCarthy. We are happy to call on you. Thank you for 
that offer.
    Mr. Yoho. And I am concerned that my farmers are not 
getting access to the tools they need to provide food for the 
world. Without the pesticides and other scientific advances, 40 
percent of global crop production could be lost because of the 
effects of weeds, pests, and disease. And I understand that the 
average research and development costs for just one new 
pesticide crop protection product to reach the market is 
roughly $256 million, and the average timeframe for a pesticide 
to be approved by the EPA and reach the market is about 10 
years. And I understand we have to do our due diligence to make 
sure that a product is safe, but we have had products that were 
approved by the EPA, and then pulled after this kind of effort. 
And what are your thoughts on that?
    Ms. McCarthy. Well, we certainly should look at what the 
full range of effort has been, and what the average is, but I 
want to look at more recent data, and see if we have been able 
to do a much better job at advancing that. It is clear we want 
to do our job to make sure that it is safe, and being 
effectively applied----
    Mr. Yoho. Absolutely.
    Ms. McCarthy.--but----
    Mr. Yoho. I mean, we need to do that.
    Ms. McCarthy. I don't think that the timelines you have 
indicated are the timelines that the Agency operates under at 
this point, sir. But if there is more work that needs to be 
done, we should do it.
    Mr. Yoho. And then I just want to say that I am concerned 
about how long it takes for the EPA to approve new products, as 
we just talked about, for the farmers or the growing 
communities. And I am also concerned that the EPA is drifting 
away from its goal set by Congress, which includes decisions 
based on sound science, rather than on input from outside 
groups trying to limit the use of the safe options for farmers. 
Some of the nonprofit groups will oppose the use of pesticides, 
no matter what their value in protecting U.S. farmers, and 
addressing world hunger, no matter how safe they are. But those 
interest groups should know that the crop protection can 
greatly reduce malnutrition for millions of children and adults 
over the next few years by safely protecting crops, and safely 
increasing yields. They will also keep costs in the U.S. lower. 
Will you commit to me today that, as the law requires, you will 
base your decisions in the EPA on sound science, and only on 
sound science?
    Ms. McCarthy. Yes. It is sound science, and the law.
    Mr. Yoho. And we see this with some of the pesticides that 
the outside groups are saying, this is bad, neonicotinoids on 
the honeybees----
    Ms. McCarthy. Sir, I want to indicate, relative to your 
first question, one of the most important things is to get new 
chemicals onto the market that are much less harmful, and much 
more effective, so you are absolutely right on both those 
questions, and their linkages, and that is what we have to work 
toward.
    Mr. Yoho. All right. And I would like for you to show 
strong leadership. Your Agency has so much power to put a pause 
on the WOTUS, as many people have talked about in here. With 26 
states suing the Federal Government and the EPA, until we can 
reach a better solution, if you could just back off, and I 
would agree with Mr. Kelly, the things he brought up.
    And then the standard of testing methodology that we have 
seen in the lead situation in Michigan, what I have seen is you 
have to run the water, or don't run the water. There is not a 
standard that everybody is using. And if you don't have a 
standard, you get skewed results. So I hope you address that, 
and I am out of time, and I yield back.
    Ms. McCarthy. We have grave concerns, and we will.
    The Chairman. The gentleman's time----
    Ms. McCarthy. Thank you.
    The Chairman.--has expired. Mr. Allen, 5 minutes.
    Mr. Allen. Thank you, Mr. Chairman, and thank you, 
Administrator McCarthy, for being here today. And, of course--
--
    Ms. McCarthy. There you are.
    Mr. Allen. Yes, I am right here, so----
    Ms. McCarthy. I am so sorry. I don't know how I lost you.
    Mr. Allen. Well, those lights are kind of bright. I have 
learned a lot here today at the hearing. I hope that you and 
your staff are taking good notes, and learning a little bit 
about some of the things that we have to deal with. I am a new 
Member of Congress. I am from Georgia, and, of course, you have 
heard the concerns about our farmers and others. But what I 
have learned is there is an obvious disconnect between the 
American people and your Agency, and your ability to carry out 
the laws that are established by the United States Congress.
    I guess my question is, what have you learned from this 
hearing today, and what do you plan to do about it?
    Ms. McCarthy. I think that I have learned that we have not 
just differences of opinion, but an understanding of what the 
Agency is doing, our intent in doing that, and that we have a 
lot of work to do to have a trusting relationship to both be 
able to talk to one another, but to listen to those concerns, 
and effectively get them into our policies and regulations.
    Mr. Allen. Would you do this: we are the people's House, 
and we report to the people. What I would like to see is a plan 
by your Agency to do just what you said you plan to do. In 
other words, if you would lay out a strategy somehow that we 
are going to get on the same page, and how are we going to do 
that, because we have differences in science. You have an 
important job. There is no question that we have issues. We 
brought those issues before you today. I mean, Flint, out in 
Colorado, there are mistakes that have been made.
    I will say that, just from my observation, as a long-term 
member of the business community, that part of that strategy 
needs to be prioritization. In other words, you are doing 
things that are affecting the economy, and affecting our 
farmers' ability to operate their farms, but then you are 
letting these other things slip through the cracks. So you need 
to reprioritize your systems, and I would like to see that in 
your strategy.
    The last question that I have is relative to the economic 
impact. When you, say Waters of the U.S., again, we have talked 
about where did that rule come from? And you need to understand 
that over \1/2\ of our farmers are retiring, and have been 
since 2009. And only 56 percent--is there a second generation 
that is coming along? Obviously, you feel our frustration, and 
our frustration is their frustration. When you start talking 
about taking people's property away from them because they have 
retained water so that they can sustain their farm, that is a 
serious, serious issue. You have millions of comments on the 
thing, and continue with the rule. So you can certainly 
understand the concern there.
    But from an economic standpoint, is your Agency at all 
connected to the fact that this economy is growing at less than 
two percent, and has been for the last 7 years, and that what 
responsibility does your Agency have for that lackluster 
growth? Have you actually gotten together and talked and is the 
growing of the economy important to you?
    Ms. McCarthy. Always, yes.
    Mr. Allen. I mean, these are jobs we are talking about. We 
are talking about--every American deserves the opportunity at a 
good job. We have, some say 90 million people who are not 
working today. And one of your strategies that I would 
recommend is that you go back and look, and see what your 
Agency could do to grow this economy, and how you could grow 
the economy. And any further comments, as far as what you are--
what you are going to move forward, while I have 44 seconds 
remaining?
    Ms. McCarthy. No, sir. I will certainly take to heart what 
you suggest. I do think we try very hard to understand how we 
can meet our mission, but do it in a way that actually advances 
the economy, moving forward. But I have no question that there 
are challenges in agriculture, and that those challenges have 
to be part of the discussion we have when we interact with this 
sector.
    Mr. Allen. And you realize that has to be a bottom up 
approach? In other words, the farmers have to be included in 
that process?
    Ms. McCarthy. Yes.
    Mr. Allen. I yield back, Mr. Chairman.
    The Chairman. The gentleman yields back. Ms. McCarthy, we 
are almost there. Two more questioners. Mr. Benishek, 5 
minutes.
    Ms. McCarthy. Thank you, Mr. Chairman.
    Mr. Benishek. Thank you, Mr. Chairman.
    Ms. McCarthy. Hello.
    Mr. Benishek. Welcome, Ms. McCarthy.
    Ms. McCarthy. Thank you.
    Mr. Benishek. Last September the EPA published an interim 
recommendation for environmental standards and eco labels for 
use in Federal procurement. And one of the recommendations for 
lumber excludes several credible standards that are widely used 
in the United States, including the Sustainable Forest 
Initiative, and the American Tree Farmer System standards. And 
we understand that this recommendation was made without 
consultation with the Department of Agriculture, who not only 
have a lot of expertise in forest management and forest 
projects, but who also publicly stated that the Sustainable 
Forest Initiative, and the American Tree Farmer System 
standards can be used to verify sustainability of forest 
products. Furthermore, it is supposedly based on a 
determination by the Department of Energy that has no formal 
analysis behind it. So can you explain the basis of this 
recommendation for Federal procurement?
    Ms. McCarthy. Well, sir, I do know that it is related to 
the Federal Government wanting to make sure that their 
purchasing reflected the full range of interests of the public.
    Mr. Benishek. Well, we already----
    Ms. McCarthy. I am----
    Mr. Benishek.--the Forest Service, or the Department of 
Agriculture has already determined that this is a sustainable 
thing. So what other factor are you taking into account?
    Ms. McCarthy. We were actually utilizing a certification 
program that was up and running that we thought had credibility 
because of its history. But we have recently been asked to 
consider opening that up other certification that----
    Mr. Benishek. What is the certification program that you 
are using?
    Ms. McCarthy. It is basically a third party certification, 
and I apologize.
    Mr. Benishek. Well, which one is that?
    I mean, these are the two most widely used certification 
processes in timber management in the country, the ones that I 
have outlined.
    Ms. McCarthy. Yes, and we are certainly opening up the 
discussion so that we can expand that. We have no interest in 
taking away the opportunity to use legitimate and very well 
tested third party certification.
    Mr. Benishek. Why wouldn't you consult with the Department 
of Agriculture prior to making this kind of a rule?
    Ms. McCarthy. I am not sure that wasn't done, sir, but I 
certainly can check.
    [The information referred to is located on p. 66.]
    Mr. Benishek. Well, it is----
    Ms. McCarthy. And you are right, if it is a forestry issue, 
we should be consulting appropriately with all the right 
Federal partners on this.
    Mr. Benishek. So when is that going to be fixed, then?
    Ms. McCarthy. Say that again?
    Mr. Benishek. You said you are going to look into it, so 
when is that going to happen?
    Ms. McCarthy. We already are looking into it. I just can't 
put my finger on it, sir, but I know that it is part of the 
work that we are doing, ongoing. I can get back to you on what 
the timeline might be.
    Mr. Benishek. So is the timeline a month?
    Ms. McCarthy. I don't know, sir, I can get back to you.
    Mr. Benishek. Three years?
    Ms. McCarthy. I can get back to you.
    Mr. Benishek. All right. I yield back.
    The Chairman. The gentleman yields back. Mr. LaMalfa for an 
additional 5 minutes. He had a couple of questions.
    Mr. LaMalfa. Thank you, Mr. Chairman, for your indulgence. 
Ms. McCarthy, once again, I will try and just keep this to 
asking for an offline clarification, and then a couple yes and 
nos. So I----
    Ms. McCarthy. Okay.
    Mr. LaMalfa.--appreciate your time, and your grace with 
which you have answered the questions today. Just to bring your 
attention quickly, a Presidential memorandum recently issued, 
it is called The Mitigating Impacts on Natural Resources from 
Development, and Encouraging Related Private Investments. I 
don't expect you to know this, and not to put you on the spot 
here, but, again, Mitigating Impacts on Natural Resources from 
Development, and Encouraging Related Private Investments. It is 
a fairly new Presidential memorandum.
    It appears to be carrying the weight of an Executive Order, 
and seems like quite a significant departure from current 
policy. Looking like it is going to go back and re-assess every 
possible impact that a man-made activity might have on public 
land, or any natural resource on Federal projects. So do you 
plan to follow this policy, and can you walk me through, in a 
letter later on, how you do plan--are you aware of that title?
    Ms. McCarthy. I have not been made familiar with the 
details, so I will have to get back to you on how----
    Mr. LaMalfa. I believe it was out in October.
    Ms. McCarthy.--my Agency would respond. We have very little 
ownership of Federal lands.
    [The information referred to is located on p. 67.]
    Mr. LaMalfa. Okay. Well, it might have an effect on all 
Federal lands, we are still catching up, I would appreciate it 
if your office can clarify to that in a letter offline here. 
And on the previous questions I had on Clean Water Act, again, 
regarding plowing, this is very important to several of my 
constituents have gotten in some hot water up in the district 
there on the section 404 exemption of the Clean Water Act.
    Current Clean Water Act regulations provide that plowing 
``will never involve a discharge, unless it changes any of 
water in the United States to dry land.'' I am familiar with 
that with growing rice, about the 1985 sodbuster, swampbuster 
regulations came in through FSA, where we are not to take 
swamps, or change waterways, things of that nature. Big things. 
Since we do have this section 404 exemption, does this 
regulation really, truly mean what it says? Because that is 
what my growers are wondering, that there is an exemption for 
section 404 under plowing.
    Ms. McCarthy. My understanding is for plowing, yes.
    Mr. LaMalfa. Okay. Was this regulation intended to assure 
farmers that their plowing would not be regulated under the 
Clean Water Act?
    Ms. McCarthy. That would be its intent, yes.
    Mr. LaMalfa. Okay. And it might be repetitive here, but I 
have to do this. Does it mean that plowing is not regulated 
under the Clean Water Act unless it actually changes waters to 
dry land?
    Ms. McCarthy. Waters to dry land?
    Mr. LaMalfa. Something deemed as waters of the United 
States. If it is changing it from water----
    Ms. McCarthy. Or the other way around----
    Mr. LaMalfa.--unless you are doing something----
    Ms. McCarthy.--change land to water.
    Mr. LaMalfa. Water--yes. A watered land to a dry land, 
which is what I talked about maybe in the swampbuster, 
sodbuster, and FSA. So you agree with that?
    Ms. McCarthy. Yes.
    Mr. LaMalfa. Okay.
    Ms. McCarthy. I think.
    Mr. LaMalfa. Can farmers continue to rely on this is the 
important takeaway here. Can they continue to rely on the 
regulation, as interpreted under section 404, as an exemption, 
and continue plowing their fields?
    Ms. McCarthy. Yes.
    Mr. LaMalfa. Okay. All right, Mr. Chairman, thank you. 
Thank you for your time and indulgence. I yield back.
    The Chairman. You bet. The gentleman yields back. I have a 
couple of questions up here. When you were talking to Mr. 
DesJarlais earlier about water jurisdiction, you said that 
biological, chemical, and physical indicators must exist to 
determine if the water is jurisdictional, yet the rule uses 
biological, chemical, or physical. So can you clarify which is 
which?
    Ms. McCarthy. It would be an or.
    The Chairman. Or? Okay.
    Ms. McCarthy. Yes.
    The Chairman. All right. So that would----
    Ms. McCarthy. It basically means that you have an ability 
to----
    The Chairman. An or is a lot broader----
    Ms. McCarthy.--pollute and destroy the downstream water.
    The Chairman. All right.
    Ms. McCarthy. That is right.
    The Chairman. So or is a much broader interpretation. Also, 
and I know you are tired of talking about the GAO report on 
social media, but whatever you do, however you do it, there 
ought to be an audit trail. There ought to be a path by which 
we can track back to how it happened, and who happened, all 
those kind of good things. But use of a tool like Thunderclap, 
which hides that--can you commit that whatever you are going to 
do with social media that you will leave in play, or you will 
use tools, or leave in place an audit trail, an ability to see 
where it came from, and who did it within your organization? 
Are you--and not use----
    Ms. McCarthy. Well, I certainly know who worked on these 
issues internally----
    The Chairman. Well, I know that, but I----
    Ms. McCarthy.--and GAO really was concerned that we--
sorry----
    The Chairman. We are almost there.
    Ms. McCarthy.--retweet----
    The Chairman. Right.
    Ms. McCarthy.--was not able to be tracked back to EPA. So 
one of the things I tried to explain, although I don't agree 
with GAO, I am not disrespecting their decision. So we will 
work with OMB. It is Office of Management and Budget that did 
the guidance on how you use this Thunderclap----
    The Chairman. Okay.
    Ms. McCarthy.--and we followed it. And we will make sure 
that we----
    The Chairman. All right.
    Ms. McCarthy.--address the----
    The Chairman. There are other innovations coming in. There 
is one called Kik, and others that allow you to anonymously do 
things, and we don't want our----
    Ms. McCarthy. The one thing you can be sure of, it will 
never be me.
    The Chairman. I got you. Well, second, let me apologize for 
how cold it is in this room. There are other offices----
    Ms. McCarthy. It is cold in this room.
    The Chairman.--in our suite that are like ovens, and so 
apparently our system doesn't know the difference between 
wintertime and summertime, so----
    Ms. McCarthy. So I can now----
    The Chairman. I apologize to that.
    Ms. McCarthy. That is okay.
    The Chairman. We do have a number of Members, and we, the 
Committee, have a number of questions we would like to submit 
for the record. We would appreciate a timely response to those. 
Not like you don't have enough to do, we are going to add to 
that. But we would like a timely response to that.
    Again, thank you for being here this morning. I know you 
anticipated that this was not going to be the most fun you 
could have on a Thursday, but----
    Ms. McCarthy. I thought it was incredibly informative----
    The Chairman. I----
    Ms. McCarthy.--and respectful----
    The Chairman. Well, thank you----
    Ms. McCarthy.--so thank you.
    The Chairman.--very much. You are very kind with that. 
Thank you for being with us for 3 hours this morning. I 
appreciate that.
    Under the rules of the Committee, the record of today's 
hearing will remain open for 10 calendar days to receive 
additional material and supplementary written responses from 
the witness to any questions posed by a Member. This hearing of 
the Committee of Agriculture is adjourned. Thank you.
    [Whereupon, at 1:01 p.m., the Committee was adjourned.]
    [Material submitted for inclusion in the record follows:]
  Submitted Letter by Hon. Dan Newhouse, a Representative in Congress 
                            from Washington
January 28, 2016

  Hon. Gina McCarthy,
  Administrator,
  U.S. Environmental Protection Agency,
  Washington, D.C.

    Dear Administrator McCarthy,

    This letter is in regard to Omak Wood Products LLC located in Omak, 
Washington in Okanogan County. As you may know Okanogan County was home 
to record setting wildfires over the last two summers. This has had an 
extremely negative effect on the community, Federal forests and the 
Colville Confederated Tribe.
    Three years ago Omak Wood Products opened for operation. 
Contributing over $60 million to the local economy and employing over 
185 people, Omak Wood Products has been an economic driver and one of 
the largest employers of this small community. Now the mill has 
announced plans for a complete shutdown at the end of February.
    The community of Omak has worked tirelessly to find another 
investor so there will be no lapse in operation and loss of jobs. 
However, Omak Wood Products has not been issued an operating permit, 
which leaves any potential investor in a state of uncertainty.
    Two years ago the EPA promised a re-write of the permit to more 
accurately reflect the current operations of the mill. Without the 
updated permit investors are unwilling and unable to move forward in 
the process of keeping the mill in production.
    It is imperative that the permit is re-written and issued 
immediately, so investors can continue with their process of acquiring 
the operation.
    I ask that you act swiftly in issuing this permit, to ensure jobs 
are not lost and an already struggling economy is not dealt another 
devastation. Thank you for your consideration of this request.
            Sincerely,
            
            
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]        
             
Hon. Dan Newhouse,
Member of Congress.
                                 ______
                                 
Supplementary Material Submitted by Hon. Gina McCarthy, Administrator, 
                  U.S. Environmental Protection Agency
Insert 1
          Mr. Crawford.--then, we can take this as an example and a 
        validation of the fact that the rulemaking process is deeply 
        flawed, and needs to be addressed, because this kind of stuff, 
        to me, is not reflective of the opportunity that should be 
        granted to the affected stakeholders. Let me switch gears with 
        you quickly in the time I have remaining. I was just told 
        yesterday that the EPA took action against a farmer who didn't 
        comply with the SPCC rules on on-farm fuel storage by failing 
        to have an SPCC plan for his oil storage tank that was 5,000 
        gallons in size, but the 2014 WOTUS specifically says that EPA 
        can only require compliance for oil storage tanks in excess of 
        6,000 gallons until such time as the EPA completes a study, and 
        a new rulemaking process is undertaken.
          My understanding is that the study is complete which 
        recommends a lower exemption threshold, but the rulemaking is 
        still not finished. So my question to you is why is the EPA 
        taking enforcement action against individuals who are not out 
        of compliance, and isn't that a violation of the law?
          Ms. McCarthy. Sir, I am happy to look into it and get back to 
        you. If it just happened yesterday, I am really not familiar 
        with it.

    The EPA is are unaware of any situation such as the one described. 
The EPA respects the limits of its legal authorities as provided by 
law. The EPA's job is to assure compliance with the environmental laws 
as passed by Congress so that communities can be safeguarded from 
exposure to unhealthy pollutants and the environment can be protected.
Insert 2
          Ms. Kuster. Thank you, Mr. Chairman, and thank you to the 
        Administrator for being with us today. Always great to have a 
        New Englander in our Committee. I will be quick. I have two 
        questions. The first one relates to this Waters of the United 
        States rule, in conjunction with the EPA regulation on 
        pesticides, and the Fish and Wildlife ruling regarding the 
        long-eared bat. And my question on behalf of farmers, 
        landowners, and timber owners in New Hampshire is how will your 
        Agency coordinate with USDA and Fish and Wildlife to minimize 
        confusion about the interplay between these three rules? If you 
        follow.
          Ms. McCarthy. That is a very good question that I am not sure 
        I can answer. I will have to get back to you, because you have 
        just baffled me with the bat question, connecting with the 
        Clean Water and the other issues I understood.

    The Clean Water Rule does not itself establish any new requirements 
regarding either the use of pesticides or compliance with the 
Endangered Species Act. As a result, issuance of the Clean Water Rule 
does not change current requirements regarding application of 
pesticides to waterbodies or provisions of the ESA, including 
provisions associated with listing of the long-eared bat. New Hampshire 
is one of the four states where the Pesticide General Permit (PGP) 
applies statewide. The EPA coordinated closely with USDA on the 
development of the 2011 permit. The EPA continues to coordinate closely 
with USDA and is currently consulting with the NMFS and FWS in the 
development and re-issuance of the 2016 PGP. Consideration of relevant 
endangered or threatened species will occur during that consultation.
Insert 3
          Mr. LaMalfa. On the issue of Section 404, and the exemptions 
        that are provided for agriculture under the Clean Water Act, 
        normal farming activities, ranching, forestry, et cetera, 
        including repeat plowing, seeding, cultivating, minor drainage, 
        harvesting for that production of the food and the fiber and 
        forest products, conservation practices, et cetera, no 
        additional requirements, for example, that an activity be 
        continuous are included.
          Some of my constituents are continuous cropping on these 
        lands, otherwise you lose your ability to have that exemption. 
        Nowhere in the law does it specify that, but that is what is 
        being carried out in my district by EPA or your associates. 
        Sometimes we refer to them as henchmen, but in the Army Corps 
        of Engineers that are carrying out some very outside the law 
        activities with this regulation. So do you agree that section 
        404 does make no additional requirements that an activity be a 
        continuously cropped, as we see it in the law?
          Ms. McCarthy. I am not aware of it, but I certainly will have 
        to get back to you on it, sir.

    When Congress enacted CWA Section 404(f) in 1978, the statute 
included the term ``normal'' to characterize farming, ranching, and 
forestry practices covered by the exemption. ``Normal'' farming, 
ranching, and forestry practices are those that are established or 
ongoing. The agencies have not interpreted ``normal'' to mean 
``continuous'' but rather that farming, ranching, or forestry has been 
previously established and ongoing on the property. If lands are left 
fallow, for example, as part of crop rotation or to rest soils, such 
lands remain subject to the exemptions. The agencies are always glad to 
answer landowner questions regarding the [section] 404(f) exemptions 
and to help landowners conduct their activities in waters consistent 
with the statute.
Insert 4
          Mr. Benishek. Last September the EPA published an interim 
        recommendation for environmental standards and eco labels for 
        use in Federal procurement. And one of the recommendations for 
        lumber excludes several credible standards that are widely used 
        in the United States, including the Sustainable Forest 
        Initiative, and the American Tree Farmer System standards. And 
        we understand that this recommendation was made without 
        consultation with the Department of Agriculture, who not only 
        have a lot of expertise in forest management and forest 
        projects, but who also publicly stated that the Sustainable 
        Forest Initiative, and the American Tree Farmer System 
        standards can be used to verify sustainability of forest 
        products. Furthermore, it is supposedly based on a 
        determination by the Department of Energy that has no formal 
        analysis behind it. So can you explain the basis of this 
        recommendation for Federal procurement?
          * * * * *
          Mr. Benishek. Why wouldn't you consult with the Department of 
        Agriculture prior to making this kind of a rule?
          Ms. McCarthy. I am not sure that wasn't done, sir, but I 
        certainly can check.

    Under Executive Order 13693--Planning for Federal Sustainability in 
the Next Decade--the EPA issued recommendations to assist Federal 
purchasers in identifying and procuring environmentally sustainable 
products. The EPA's Interim Recommendation for the lumber/wood category 
is based on the Department of Energy's Fiscal Year 2016 (FY16) Priority 
Products List.
    As a result of stakeholder inquiries since the release of the 
Interim Recommendation, the EPA has met and is continuing to work with 
USDA and DOE's Office of Sustainable Environmental Stewardship to gain 
further information. The EPA's Standards Executive is reaching out to 
the Sustainable Forestry Initiative, the American Tree Farm System, and 
the other forestry labels that stakeholders have requested the EPA 
consider. The EPA will be in touch with these groups regarding the 
agency's review of forestry labels and their alignment with the 
National Technology Transfer and Advancement Act, the OMB Circular A-
119, and related Federal policies that guide the EPA's use of voluntary 
consensus standards and private-sector conformity assessment 
activities. In addition, the EPA continues its progress with piloting 
the Guidelines for Assessing Standards and Ecolabels for Use in Federal 
Procurement, and hopes that information gleaned from this process will 
inform thinking related to the lumber/wood category. Finally, DOE 
continues to conduct research to inform their FY16 Priority Products 
List. The EPA looks forward to reviewing all of this additional data to 
inform if and how the lumber/wood category of Interim Recommendations 
might be revised.
    The EPA has, and will continue to provide, mechanisms for public 
input as we develop these recommendations. The agency issued Federal 
Register Notices on the initial draft guidelines in 2014 and in March 
2015 for the launch of our pilot work.\1\ Those FRNs were open to 
public comment and they marked the beginning of our efforts to engage 
multi-stakeholder panels whose counsel will be considered as we move to 
finalize our recommendations. Further, any Federal acquisition 
requirements stemming from the recommendations would include a public 
comment process prior to incorporation into the Federal Acquisition 
Regulations. As such, FAR Case 20 15-033 has been developed in order to 
integrate the new requirements of E.O. 13693 into the FAR. All next 
steps related to this case, including as to when it will be available 
to the public, are viewable at http://www.acq.osd.mil/dpap/dars/
far_case_status.html.
---------------------------------------------------------------------------
    \1\ Federal Register Notice, February 27, 2014, ``Draft Guidelines 
for Product Environmental Performance Standards and Ecolabels for 
Voluntary Use in Federal Procurement'' (79 FR 11102) [See Attachment 
1]. https://www.gpo.gov/fdsys/pkg/FR-2014-02-27/pdf/2014-04329.pdf.
    Federal Register Notice, March 19, 2015, ``Agency Information 
Collection Activities; Proposed Collection and Comment Request; 
Assessment of Environmental Performance Standards and Ecolabels for 
Federal Procurement'' (80 FR 14372). [See Attachment 2] https://
www.gpo.gov/fdsys/pkg/FR-2015-03-19/pdf/2015-06275.pdf.
---------------------------------------------------------------------------
Insert 5
          Mr. LaMalfa.--appreciate your time, and your grace with which 
        you have answered the questions today. Just to bring your 
        attention quickly, a Presidential memorandum recently issued, 
        it is called The Mitigating Impacts on Natural Resources from 
        Development, and Encouraging Related Private Investments. I 
        don't expect you to know this, and not to put you on the spot 
        here, but, again, Mitigating Impacts on Natural Resources from 
        Development, and Encouraging Related Private Investments. It is 
        a fairly new Presidential memorandum.
          It appears to be carrying the weight of an Executive Order, 
        and seems like quite a significant departure from current 
        policy. Looking like it is going to go back and re-assess every 
        possible impact that a man-made activity might have on public 
        land, or any natural resource on Federal projects. So do you 
        plan to follow this policy, and can you walk me through, in a 
        letter later on, how you do plan--are you aware of that title?
          Ms. McCarthy. I have not been made familiar with the details, 
        so I will have to get back to you on how----
          Mr. LaMalfa. I believe it was out in October.
          Ms. McCarthy.--my Agency would respond. We have very little 
        ownership of Federal lands.

    The Presidential Memorandum, ``Mitigating Impacts on Natural 
Resources from Development and Encouraging Related Private 
Investment,'' was issued on November 3, 2015, and applies to the 
Departments of the Interior, Defense, and Agriculture and to the EPA 
and NOAA. A key goal of the Memorandum is to ``increase private 
investment in natural resource restoration'' and to accomplish this by 
ensuring that ``[f]ederal policies are clear, work similarly across 
agencies, and are implemented consistently across agencies.'' Section 1 
calls on agencies to ``adopt a clear and consistent approach for 
avoidance and minimization of, and compensatory mitigation for, the 
impacts of their activities and the projects they approve.'' Clear 
policies with respect to mitigation are expected to offer opportunities 
for increasing private investment in natural resource restoration. 
General ``principles'' guiding this effort are defined in section 3, 
and section 4 calls on selected agencies to review and update specific 
manuals, handbooks, and policies. As indicated in section 5(b), the 
Memorandum is to be ``implemented consistent with applicable law.''
                                 ______
                                 
                          Submitted Questions
Response from Hon. Gina McCarthy, Administrator, U.S. Environmental 
        Protection Agency
September 6, 2016

  Hon. K. Michael Conaway,
  Chairman,
  House Committee on Agriculture,
  Washington, D.C.;

  Hon. Collin C. Peterson,
  Ranking Minority Member,
  House Committee on Agriculture,
  Washington, D.C.

    Dear Mr. Chairman/Congressman Peterson: *
---------------------------------------------------------------------------
    * Editor's note: There were identical letters sent to the Chairman 
and Mr. Peterson. For the purpose of publishing they have been 
combined.

    Thank you for the opportunity to respond to the questions for the 
record following the February 11, 2016, hearing on impacts of the 
Environmental Protection Agency's actions on the rural economy. 
Enclosed are the EPA's responses to the questions.
    If you have any further questions, please contact me or your staff 
may contact Sven-Erik Kaiser at [Redacted] or [Redacted].
            Sincerely,
            
   [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]         
  
  
  
Nichole Distefano,
Associate Administrator.
Questions Submitted by Hon. K. Michael Conaway, a Representative in 
        Congress from Texas
    Question 1. The GAO report on illegal grassroots lobbying points to 
the tweet ``I love clean water'' as one of the violations. What we have 
failed to discuss was EPA's use of the innovative tool ``Thunderclap'' 
to push that tweet to more viewers, around 1.8 million. In addition to 
twitter, EPA used Facebook and YouTube for an aggressive social media 
campaign for the WOTUS rule. Did EPA count responses to the social 
media campaign as comments in support of the rule? How many of those 
people actually read and understood the details of the rule?
    Answer. The EPA did not count responses on social media as 
comments. For any statements made in the preamble of the final rule or 
to the public regarding the number of comments received, the EPA only 
counted comments submitted to the docket or sent to the dedicated e-
mail address for this rulemaking.

    Question 2. The 6th Circuit Court of Appeals, in its order to 
temporarily stay the rule, found that the burden of the WOTUS Rule 
outweighed any harm to the agencies in keeping the status quo. What are 
your thoughts on this?
    Answer. The EPA and the U.S. Army Corps of Engineers revised their 
longstanding definition of the term ``waters of the United States'' to 
provide the public with more consistent, predictable, and 
understandable regulations defining the scope of the Clean Water Act 
(CWA). The result is a new rule intended to be faster, easier, and 
cheaper to implement saving the public time and money. Delaying 
implementation of the Clean Water Rule prevents the agencies from 
providing the public with these significant improvements. The agencies 
are, however, fully complying with the 6th Circuit order by staying 
implementation of the Clean Water Rule and implementing the prior 
regulations consistent with the best science and the law.

    Question 3. Assuming the Administration will continue to keep the 
final rule as written, and that the rule is to be implemented, will you 
consider delaying implementation of the rule to provide the time 
necessary for the Agencies to get adequately trained and for the 
regulated community to understand how Federal jurisdictional decisions 
will be made so that they can comply?
    Answer. The agencies are using the time created by the stay to 
address questions regarding the Clean Water Rule raised by states, 
local governments, and the public, and to provide agency field staff 
with additional training to ensure we are in the best possible position 
to fairly and effectively implement the rule when the stay is lifted. 
We will also continue to update information and respond to questions 
when the new rule goes into effect to provide the public with the 
transparency and clarity needed to make use of the new rule more timely 
and less costly.

    Question 4. How is EPA ensuring that the new Waters of the United 
States (WOTUS) Rule is not being utilized or implemented, in light of 
the current nationwide stay? What actions has EPA taken to ensure that 
all EPA regions and staff are not using or implementing the Rule?
    Answer. The EPA and the U.S. Army Corps of Engineers distributed 
national guidance to their field offices on the same day the 6th 
Circuit stay was issued directing all field staff to cease implementing 
the Clean Water Rule and instead resume application of the agencies' 
prior regulations defining the scope of CWA jurisdiction. The agencies 
regularly work with their field staff to respond to questions and to 
ensure the stay is being implemented consistent with the court's 
decision.

    Question 5. Do you believe that the Army Corps is capable of 
executing the Clean Water Act 404 program without EPA's involvement? 
Why or why not?
    Answer. The EPA and the U.S. Army Corps of Engineers have worked 
together effectively in the implementation of the CWA section 404 
program for more than 40 years since enactment of the statute in 1972. 
The agencies will continue to build from their experience to make 
future implementation of the section 404 program even more responsive 
to permit applicants as we work to protect human health and the 
environment.

    Question 6. When dealing with interagency disagreements and 
responses to public comments during the development of the WOTUS Rule, 
who had the final say on what was and was not considered a Water of the 
U.S.?
    Answer. Final decisions regarding the Clean Water Rule were made 
jointly by senior policy managers at the Department of the Army and the 
EPA following extensive collaboration and discussion and consistent 
with science and the law.

    Question 7. EPA has made it a point to state that ditches are not 
included as jurisdictional in the final Waters of the United States 
rule. However, if a ditch can be classified as a tributary, and ditches 
are generally formed through excavation activities, could you clarify 
what types of ditches are truly exempt?
    Answer. The agencies have stated consistently that most ditches 
were subject to regulation under the CWA during the 1970s, 1980s, and 
1990s--and that actual regulation was inconsistent and unclear causing 
uncertainty for landowners such as farmers and ranchers. A key goal of 
the Clean Water Rule is to eliminate this uncertainty and make clear 
for landowners, for the first time, the types of ditches that are and 
are not covered by the CWA. An important part of the new Clean Water 
Rule is a list of waters, including many types of ditches, that are 
always excluded from regulation under the CWA. The new rule makes clear 
that most ditches on farmlands, including all ditches that flow only 
after it rains, or ditches excavated from dry land, are never covered 
under the CWA. In addition, the new rule preserves all farming, 
ranching, and forestry exemptions, including ditch exemptions. These 
exemptions in Federal law allow landowners to construct irrigation 
ditches and maintain drainage ditches, for example, without needing to 
get permits or approval from the government.

    Question 8. Would the ditch exemption be automatically given if the 
business, farmer, or local government believes their ditch is exempt, 
or do they have to prove the ditch is exempt? Will they have to ask for 
the exemption?
    Answer. The agencies wrote the Clean Water Rule to make it clear 
and understandable. The rule does not change the longstanding 
application of the section 404(f) exemptions. The public, for example, 
is not required to obtain confirmation or approval from the government 
that an exemption applies. The agencies are available at no cost, 
however, to answer questions regarding jurisdiction, and the U.S. Army 
Corps of Engineers can provide landowners with written jurisdictional 
determinations regarding the status of ditches on their property.

    Question 9. What actions have the Agency taken to ensure the Clean 
Water Act's prior converted cropland exemption is being preserved?
    Answer. The Prior Converted Cropland (PCC) exclusion was written 
into the agencies' CWA regulations in 1993 to provide the public with 
certainty regarding the jurisdictional status of these wetlands. This 
regulatory exclusion was not changed by the Clean Water Rule, and the 
preamble to the final rule makes clear that there will be no change in 
the implementation of the exclusion as the Clean Water Rule is put into 
effect. The public can be certain the PCC exclusion will continue to be 
implemented as it has been since 1993.

    Question 10. What actions have the Agency taken to ensure the Clean 
Water Act exemptions for normal farming activities under Section 404(f) 
are being preserved?
    Answer. The agencies issued regulations following enactment of the 
CWA section 404(f) exemptions in 1978 and these regulations were not 
changed by the Clean Water Rule. The agencies made clear in the 
Preamble to the final Clean Water Rule and in information published on 
their websites that there will also be no change to implementation of 
the section 404(f) exemptions resulting from the Clean Water Rule. The 
public can be certain that the section 404(f) exemptions will continue 
to be applied as they have been since their enactment in 1978.

    Question 11. On December 14, 2015, the Government Accountability 
Office (GAO) published a legal opinion finding that the EPA violated 
Federal law by engaging in covert propaganda and grassroots lobbying. 
How do you plan to rectify what many in the agricultural community 
consider a flawed rule from a flawed process?
    Answer. In promulgating the Clean Water Rule, the EPA complied 
fully with the CWA and all laws applicable to the rulemaking process. 
The GAO opinion did not comment on or examine the EPA's rulemaking 
process. The GAO evaluated the EPA's use of certain social media 
platforms tools during the time of the rulemaking to determine whether 
they violated restrictions that prohibit using Federal funds for either 
(1) indirectly lobbying Congress in support of, or in opposition to 
pending legislation or (2) publicity that is self-aggrandizing, purely 
partisan, or conceals the agency's role in sponsoring the material. 
After examining a database of social media outreach materials, the GAO 
took issue with only a single EPA blog post with two hyperlinks to 
articles on third party websites and the EPA's use of a social media 
tool called ``Thunderclap.'' The alleged violations had no impact on 
the EPA's rulemaking process or on the EPA's compliance with any law 
applicable to the rulemaking, including the Administrative Procedure 
Act.

    Question 12. What role did USDA play in the development of the 
WOTUS rule? When did EPA begin the process of developing the rule? When 
did you first engage USDA?
    Answer. The agencies consulted with other Federal agencies, 
including the U.S. Department of Agriculture, throughout the process of 
developing the Clean Water Rule. USDA provided comments on the Clean 
Water Rule to the Office of Management and Budget (OMB) consistent with 
the interagency review process governed by Executive Order 12866. EPA 
and the U.S. Army Corps of Engineers used these comments in working to 
meet a key Clean Water Rule goal of improving clarity and 
predictability for farmers and reducing regulatory burdens on 
agricultural lands. The agencies began consulting with the USDA staff 
as a part of the process to prepare jurisdictional guidance during the 
first term of the Obama Administration and throughout the subsequent 
process of developing the Clean Water Rule. USDA has consistently 
emphasized agriculture's outstanding stewardship track record in 
delivering water resource benefits locally, regionally, and nationally.

    Question 13. Some observers suggest that the proposed 70 parts per 
million (ppm) standard for ozone is below naturally occurring 
background levels. By reducing the ozone standard to 70 ppm, large 
swaths (largely rural) of the country will likely be designated as 
nonattainment. If this is correct, the new standard would be virtually 
unachievable. In light of this, how does EPA justify the billions, if 
not trillions, of dollars of burdensome costs that could be expected to 
be borne ultimately by the American people and their communities to 
attempt to comply with an impossible standard?
    Answer. The EPA projections show that the vast majority of U.S. 
counties will meet the revised standards by 2025 without taking 
additional action to reduce emissions. Existing and proposed Federal 
rules, such as Tier 3 vehicle standards, Mercury and Air Toxics 
Standards, and measures to address the 2010 sulfur dioxide National 
Ambient Air Quality Standards (NAAQS) will help states meet the 
standards by reducing ozone forming pollution.
    Uncontrollable background concentrations of ozone, from sources 
like natural events, e.g., wildfires, or foreign emissions, are not 
expected to preclude attainment of a revised ozone standard with a 
level of 70 ppb. In addition, Congress established requirements for 
implementing the health based NAAQS standards that recognize issues 
like background ozone and interstate transport to ensure that states 
are not responsible for emissions they cannot reasonably control. The 
Clean Air Act does not require states to demonstrate attainment of 
NAAQS in all areas. Areas that are significantly affected by emissions 
outside their control may receive special consideration.
    When setting the level of a NAAQS, the EPA is prohibited by law 
from considering the costs of implementation. Courts, including the 
Supreme Court, have held uniformly that the EPA may not consider issues 
of implementation costs when establishing NAAQS. The Clean Air Act 
directs the EPA to set NAAQS at a level requisite to protect public 
health with an adequate margin of safety and to protect the public 
welfare from any known or anticipated adverse effects of air 
pollutants.

    Question 14. Our country has made great strides in reducing our 
ozone levels--roughly 33% reduction since 1980--by keeping the 
standards practical and attainable. However, EPA is now pursuing a 
standard that cannot be achieved and therefore whose health benefits 
would never be realized. What is EPA's justification for creating an 
ozone standard that is set so low that it cannot be reasonably achieved 
while recognizing that the health benefits from such a standard will 
never be reached?
    Answer. The EPA believes that a primary ozone standard with a level 
of 70 ppb will substantially improve public health protection across 
the country and will provide the adequate margin of safety the law 
requires--including for children, who are one of the groups most at 
risk from ozone exposure. The public health benefits of a 70 ppb ozone 
NAAQS are significant--estimated at $2.9 to $5.9 billion annually in 
2025. It is also worthwhile to note that the EPA projections show that 
the vast majority of U.S. counties will meet the revised standards by 
2025 without taking additional action to reduce emissions. Existing and 
proposed Federal rules, such as Tier 3 vehicle standards, Mercury and 
Air Toxics Standards, and measures to address the 2010 sulfur dioxide 
NAAQS will help states meet the standards by reducing ozone forming 
pollution.

    Question 15. What specific impact would being designated as a 
nonattainment area under the new standard have on job creation and 
economic growth in rural communities?
    Answer. Once the EPA sets a new air quality standard, or revises an 
existing standard, the Clean Air Act requires the EPA to designate 
areas as meeting the standards (attainment areas) or not meeting them 
(nonattainment areas) based on local air quality. The agency also may 
designate an area as unclassifiable, meaning there is not enough 
information to make a determination. States make area designations 
recommendations, and the EPA works closely with states and Tribes as it 
finalizes the initial designations and boundaries for any nonattainment 
areas.
    All states with nonattainment areas must develop emission 
inventories and implement a preconstruction permitting program designed 
to provide additional air quality safeguards for those areas. For 
nonattainment areas classified ``moderate'' or higher, which are 
unlikely to be rural areas, states must develop state implementation 
plans showing how the areas will meet the standards. These plans must 
include reasonable available control technology standards for certain 
types of ozone producing emission sources in the nonattainment area. 
They also can include Federal measures that will result in local 
emissions reductions, such as national mobile source requirements. 
States may take area-specific considerations into account in developing 
these plans.

    Question 16. EPA finalized the recent 2015 stringent ozone standard 
when it hadn't even released implementation rules for the last standard 
set in 2008. In fact, states were forced to make designations under the 
standard without final implementation rules from EPA. Doesn't it make 
sense to get the 2008 standard implemented before burdening states with 
double-regulation?
    Answer. The EPA and state co-regulators share a long history of 
managing ozone air quality under the Clean Air Act, underpinned by a 
wealth of previously issued EPA rules and guidance. The overall 
framework and policy approach reflected in the implementing regulations 
for the 2008 ozone standards provide an effective and appropriate 
template for the general approach states would follow in planning for 
attainment of the 2015 ozone NAAQS. Planning and implementation work to 
meet the 2015 ozone standard will build on progress states have already 
made to plan for and meet the 2008 standards. In particular for areas 
where states are still actively working toward attaining the 2008 ozone 
NAAQS, the EPA is committed to helping air agencies identify and take 
advantage of potential planning and emissions control efficiencies that 
may occur within the horizon for attaining the 2015 standards. 
Following past precedent, the EPA intends to propose revoking the 2008 
standards and provide transition rules intended to help avoid any 
potential inefficiencies as states begin implementing the Clean Air 
Act's requirements for the 2015 standards.

    Question 17. The National Association of Clean Air Agencies 
testified to EPA that the new ozone standard ``will have a profound 
impact on the work of state and local air pollution control agencies.'' 
Did EPA assess what impact implementing the new ozone standards would 
have on state and local agencies already implementing the 2008 
standard--shouldn't these standards be harmonized?
    Answer. As provided in the previous answer, the EPA and state co-
regulators share a long history of managing ozone air quality under the 
Clean Air Act, underpinned by a wealth of previously issued EPA rules 
and guidance. Planning and implementation work to meet the 2015 ozone 
standard will build on progress states have already made to plan for 
and meet the 2008 standards. The overall framework and policy approach 
reflected in the implementing regulations for the 2008 ozone standards 
provide an effective and appropriate template for the general approach 
states would follow in planning for attainment of the revised ozone 
NAAQS. In particular for areas where states are still actively working 
toward attaining the 2008 ozone NAAQS, the EPA is committed to continue 
helping air agencies identify and take advantage of potential planning 
and emissions control efficiencies that may occur within the horizon 
for attaining the 2015 standards. Following past precedent, the EPA 
intends to propose revoking the 2008 standards and provide transition 
rules intended to help avoid any potential inefficiencies as states 
begin implementing the Clean Air Act's requirements for the 2015 
standards.

    Question 18. EPA chose to project the costs of its new ozone 
standard to 2025, 8 years after counties will be designated as 
nonattainment. What consequences will those counties face while 
designated nonattainment?
    Answer. The Clean Air Act requires that within 3 years of the EPA 
setting a new air quality standard, or revising an existing standard, 
the EPA must designate areas as meeting the standards (attainment 
areas) or not meeting them (nonattainment areas) based on local air 
quality. The agency also may designate an area as unclassifiable, 
meaning there is not enough information to make a determination. 
Governors make initial designations recommendations, and the EPA works 
closely with states and Tribes as it determines initial designations 
and boundaries for nonattainment areas.
    All states with nonattainment areas must develop emission 
inventories and implement a preconstruction permitting program designed 
to provide additional air quality safeguards for those areas. States 
with nonattainment areas classified as ``Moderate'' or higher must 
develop state implementation plans showing how the areas will meet the 
standards. These states also must adopt reasonable available control 
technology standards for certain types of emission sources in the 
nonattainment. They also can included Federal measures that will result 
in local emissions reductions, such as national mobile source 
requirements.

    Question 19. EPA chose to project the costs of its new ozone 
standard to 2025. Since EPA bases its entire economic analysis on 
predicted 2025 air quality, will the Agency support extending 
compliance deadlines under the standards to 2025?
    Answer. The Clean Air Act governs the process and timing for 
initial area designations and associated compliance deadlines after the 
EPA establishes a new or revised NAAQS. Following Clean Air Act 
requirements, the EPA anticipates the following schedule for the 2015 
ozone NAAQS:

   By October 2017: the EPA issues final area designations; 
        those designations likely would be based on 2014-2016 air 
        quality data. If preconstruction permitting program 
        requirements for the nonattainment area do not already exist, 
        Federal permitting regulations apply until they are replaced by 
        state adopted programs;

   2019: States submit area-specific inventories of ozone 
        producing emissions;

   2020 to 2021: For nonattainment areas classified as 
        ``Moderate'' and above, states, and any Tribes that choose to 
        do so, complete development of implementation plans, outlining 
        how they will reduce pollution to meet the standards. State and 
        Tribal plans can include Federal measures, and any local or 
        statewide measures needed to demonstrate that a nonattainment 
        area will meet the standards by its attainment date; and

   2020 to 2037: Nonattainment areas are required to meet the 
        primary (health) standard at varying deadlines throughout this 
        time, depending on the severity of an area's ozone problem.

    Question 20. I am concerned that EPA continues to propose new 
programs like the Urban Waters program and the Resilient Finance Center 
rather than finding ways to support these goals through the Agency's 
core programs. What is EPA doing to ensure that these programs aren't 
creating a fragmented approach to water resource protection?
    Answer. The Urban Waters Program and the Water Infrastructure and 
Resiliency Finance Center are examples of initiatives that cross water 
program boundaries and are most effectively supported in ways that 
reflect this multi-program relationship. The Water Infrastructure and 
Resiliency Finance Center, for example, identifies financing approaches 
to help communities make better informed decisions for local needs such 
as drinking water, wastewater, and storm water infrastructure. The 
Center increases collaboration between state and local governments and 
the private-sector, expands public-private partnerships, and increases 
the use of Federal credit programs. These are all actions that reach 
beyond the activities of one core Federal water program and, instead, 
serve to enhance and strengthen multiple Federal, state, and local 
objectives. We believe that managing these programs outside a single 
core program, therefore, allows the EPA to more effectively integrate 
and support multiple water efforts and to take advantage of these 
initiatives and reduce potential fragmentation in Federal, state, and 
local clean water programs.

    Question 21. Will EPA use the time the Supreme Court has provided 
everyone to better understand electric grid operations so you will 
better understand and account for the cost and reliability issues 
associated with your assumptions about unprecedented growth in 
renewables? Do you agree with President Obama and Secretary Vilsack 
that agricultural products can help reduce the nation's carbon 
emissions? Why does the Clean Power Plan by default treat carbon from 
agricultural crops the same as fossil fuel emissions?
    Answer. On February 9, the Supreme Court granted a motion to stay 
the Clean Power Plan. As a result of that action, states are not 
currently required to submit a state plan or a request for extension by 
September 6, 2016.
    A core principle of the Clean Power Plan (CPP) is the importance of 
providing states the flexibility to develop their own approaches to 
address carbon dioxide (CO2) emissions. This flexibility 
recognizes the unique circumstances of each state when it comes to 
their energy mix, and their approaches to energy efficiency and 
renewable energy. In the CPP, states have the flexibility to choose 
whether or not to include biomass as part of their state plans, and if 
so, the flexibility to describe the types of biomass that are being 
proposed for use under their state plans, how those proposed feedstocks 
or feedstock categories should be considered as ``qualified biomass'' 
(i.e., a biomass feedstock that is demonstrated as a method to control 
increases of CO2 levels in the atmosphere), and explain the 
proposed valuation of biogenic CO2 emissions.
    The EPA generally acknowledges the CO2 and climate 
policy benefits of waste-derived biogenic feedstocks and certain 
forest- and agriculture-derived industrial byproduct feedstocks. The 
final rule also provides that states may demonstrate that the use of 
agricultural and forest biomass feedstocks appropriately control 
increases of CO2 levels in the atmosphere.

    Question 22. How long has EPA been working on its Biogenic 
Accounting Framework for agricultural crops? When does EPA anticipate 
finishing that process?
    Answer. As part of the EPA's effort to advance the technical 
understanding of the role of biomass in addressing greenhouse gas 
emissions, in November 2014 the EPA released the second draft of its 
scientific report, Framework for Assessing Biogenic Carbon Dioxide for 
Stationary Sources. The revised report takes into account Science 
Advisory Board peer review recommendations on the 2011 Draft Framework, 
as well as the latest information from the scientific community and 
other stakeholders. In February 2016, the biomass SAB Advisory panel 
delivered its draft final peer review report to the full chartered SAB 
for a quality review. The full chartered SAB held a public, in person 
quality review meeting at the end of March 2016 and offered its 
recommendations on the draft final peer review report to the biomass 
SAB Advisory Panel. EPA is reviewing recommendations from the full 
chartered SAB as well as those finalized by the biomass SAB Advisory 
Panel. More information on the chartered SAB meeting can be found at 
http://yosemite.epa.gov/sab/sabpeople.nsf/WebCommittees/BOARD.

    Question 23. The public is threatened by insect-borne diseases--
West Nile Virus is a good example. Some of the critical products used 
to control mosquitoes are also the backbone of Integrated Pest 
Management plans. These include a class of pesticides known as OP's. 
Tell me more about EPA's plans for OP's used to protect public health 
against very dangerous and prolific pests. How is EPA considering the 
importance of these products to human health in its risk assessments? 
Is EPA following established protocols for consultations with CDC and 
other Federal agencies with public health expertise?
    Answer. The EPA recognizes that certain organophosphate pesticides 
are important tools in strategies to control pests that vector 
diseases. The EPA considers the benefits, both public health and 
others, of these pesticides, along with their risks, before making any 
regulatory decisions. The EPA consults with the Centers for Disease 
Control and Prevention when making a regulatory decision for any 
pesticide used to control a pest of public health significance. In 
addition, EPA consults with the Secretary of Health and Human Services 
on the identification of pests of significant public health importance 
and solicits the views of the Secretary on certain environmental 
pesticide regulations. The EPA also frequently consults with other 
interested stakeholders to ensure that the agency has a complete 
picture of the benefits and have properly evaluated any proposed 
mitigation. Fortunately there are a number of other EPA registered 
products that can be used for effective mosquito control.
    The EPA is currently evaluating the organophosphates in our 
statutorily mandated registration review program. The agency will take 
comment on our assessments before consideration of any risk management. 
In addition, the EPA will engage with the registrants and the public 
health community to ensure that we are considering all relevant data in 
our assessments. Where states, localities, other Federal agencies, and 
user groups have relevant information that could aid in the analysis, 
the agency will utilize this information as well. Similarly, as new 
scientific information becomes available that changes our understanding 
of potential risks as well as pesticide efficacy, we can revisit our 
decisions.

    Question 24. Exactly how many new products or product uses have 
been brought into the market, and, how many products and uses have been 
restricted or effectively lost under your tenure as Administrator?
    Answer. Approximately 170 new active ingredients and more than 
1,700 new uses of previously registered active ingredients have been 
registered during my tenure. During the same time period, the EPA made 
about 165 registration review decisions on active ingredients and 
approximately 300 uses have been canceled. Registration review is the 
agency's current re-evaluation program, which focuses on the pesticide 
active ingredient rather than products or uses.
    Of the 165 registration review decisions on active ingredients, 
about \1/2\ of these decisions required no changes or minor label 
changes. Labeling changes can include removing uses, reducing 
application rates and adding protections for vulnerable populations to 
address specific human health and ecological concerns. They also 
improve clarity so that the user can better understand the label and 
use the product safely. The other \1/2\ of the decisions made involved 
voluntary cancellation by the registrants primarily for business 
reasons.

    Question 25. Rather than going through normal public process to 
propose to cancel a registration--has the Agency ever asked a court to 
order to vacate a registration? If so, please describe those 
circumstances.
    Answer. Subsequent to registering Enlist Duo, the EPA became aware 
of previously existing information about possible synergistic effects 
that had not been considered as part of the initial registration 
decision. As a result, the agency could no longer represent to the 
Court that its conclusions were correct regarding whether issuance of 
the registration met the standard in the Federal Insecticide, 
Fungicide, and Rodenticide Act (FIFRA) and whether the buffer zones 
included in the registration support the finding that the registration 
will have no effect upon threatened or endangered plant species. The 
EPA therefore sought from the Court an order of remand with vacatur. 
This is the first time that the EPA has asked a court to vacate a 
pesticide registration.

    Question 26. EPA is supposed to take into account the benefits of a 
product, such as protection of the public health from disease-carrying 
pests, protection of our nation's buildings and infrastructure, 
protection of the food supply. However, recent EPA activities appear to 
focus disproportionately on the hazard side of that assessment while 
discounting factors like exposure and benefits. What additional data 
does the EPA need in order to better account for pesticide benefits?
    Answer. Under FIFRA, the EPA must ensure that a pesticide does not 
cause ``unreasonable adverse effects.'' An important factor in that 
determination is the consideration of other factors including the 
benefits associated with the use of the pesticide. The EPA typically 
starts the evaluation of a pesticide by conducting risk assessments to 
determine if there are any ``risks of concern'' before weighing the 
other factors. However, before taking any registration action, the EPA 
considers the benefits the pesticide offers and the impacts of any 
mitigation option on the users of the pesticide (that is, any loss of 
benefits). A risk-benefit analysis is applied to ecological and 
occupational risks under FIFRA.
    When considering the use of a pesticide on food, the agency must 
consider all dietary risk from residues that result from a pesticide 
use and establish a tolerance (or exemption) under the Federal Food, 
Drug, and Cosmetic Act (FFDCA). Generally, the safety standard for the 
review of pesticide chemical residues under the FFDCA is a risk-based 
standard that requires the EPA to make a ``reasonable certainty of no 
harm'' determination when it establishes a pesticide tolerance to 
regulate the amount of pesticide residue in food. When making a 
determination under FFDCA, the EPA normally considers options for 
meeting the safety standard and tries to select the one with the least 
impact on the user community. If the safety standard of FFDCA is not 
met, benefits cannot be considered in order to allow the use of the 
pesticide.
    Benefits may be considered when making a regulatory decision under 
FIFRA when considering ecological or risks posed to workers. In 
assessing the benefits of the use of agricultural pesticides, the EPA 
largely relies on information generated by the land-grant university 
system, USDA, and other stakeholders. Information on non-agricultural 
uses, including public health, residential, and industrial uses, is 
more limited and the EPA relies heavily on our public process to 
solicit information about the pests targeted by specific pesticides and 
the advantages a specific pesticide may have in particular situations.

    Question 27. I understand that EPA will complete and release its 5 
year re-issuance of the Clean Water Act-based Pesticide General Permit. 
What changes should we expect to see in the reissued Pesticides General 
Permit based on the new Clean Water Rule expansion?
    Answer. The Clean Water Rule does not itself establish any new 
requirements regarding the use of pesticides. As a result, issuance of 
the Clean Water Rule does not change the National Pollutant Discharge 
Elimination System (NPDES) requirements regarding application of 
pesticides to waterbodies. The EPA's experience with the Pesticide 
General Permit (PGP) during the last four years demonstrates it is 
working well to ensure that use of pesticides is being managed to 
minimize potential regulatory burdens while effectively protecting the 
nation's water resources and public health. Conditions and requirements 
in the EPA's proposed PGP remain largely unchanged from the 2011 PGP. 
Final decisions regarding re-issuance of the PGP will reflect public 
input and coordination with stakeholders.

    Question 28. Please provide a comprehensive list of all Agency 
actions, not just rulemakings, over the last 8 years and those planned 
through the end of 2016 that restricted or have the potential to 
restrict existing or new uses of pesticides.
    Answer. The pesticide registration review process began in 2006 
with the first decisions being made a few years later. To date, 165 
decisions have been made. Of these decisions, 83 involved requests from 
the registrants to voluntarily cancel their registrations, in most 
cases for business decisions that were independent of the agency's 
review. For the remaining 82, many required no change to the 
registration or minor label clarification to make it easier for the 
user to understand and use the product correctly. The EPA's anticipated 
registration review schedule can be found at www.epa.gov/pesticide-
reevaluation/registration-review-schedules [See Attachment 3].
    During the same time period, the EPA has registered approximately 
170 new pesticide active ingredients and over 1,700 new uses of 
already-registered active ingredients, providing numerous new products 
for use in agricultural and non-agricultural settings. These newly 
registered products are designed to address emerging pest pressures and 
will have a significant role in the marketplace.
    Of these regulatory decisions to restrict or cancel certain 
registrations, the EPA made these decisions after careful consideration 
of all available data and consistent with existing statutory 
requirements. For example:

   In 2010, the EPA announced its decision to terminate all 
        uses of endosulfan due to unacceptable risks to farmworkers and 
        wildlife. The EPA signed a Memorandum of Agreement with the 
        registrants of endosulfan that resulted in voluntary 
        cancellation and provided for a phase-out of all existing 
        endosulfan uses in the United States in order to allow time for 
        growers to transition to newer alternatives;

   In 2012, the EPA limited the use of chlorpyrifos by 
        significantly lowering pesticide application rates and creating 
        ``no-spray'' buffer zones around public spaces, including 
        recreational areas and homes, due to concerns for unacceptable 
        risks to children and bystanders;

   In 2014, the EPA canceled propoxur pet collars. In the fall 
        of 2013, the EPA completed the propoxur pet collar risk 
        assessment. The EPA's risk assessment indicated risks of 
        concern to children from exposure to pet collars containing 
        propoxur;

   In 2015, the EPA reached an agreement with Reckitt 
        Benckiser, the manufacturer, to cancel all distribution of 12 
        consumer use d-CON products that did not meet the EPA's current 
        safety standards, raising concerns for risks to children and 
        pets. Additionally, eight of the 12 products pose unacceptable 
        risks to certain wildlife;

   In 2015, the EPA proposed to revoke all chlorpyrifos 
        tolerances due to concerns with estimated exposure from 
        drinking water in certain watersheds. A final tolerance rule is 
        anticipated in March 2017;

   On November 24, 2015, while the issuance of the initial 
        registration was being challenged in Federal court, the EPA 
        sought the remand and vacatur of the Enlist Duo registration 
        because the EPA became aware of previously existing information 
        about possible synergistic effects that had not been provided 
        to the EPA or considered as part of the initial registration 
        decision. The EPA cannot be sure, without a full analysis of 
        the new information, that the current registration does not 
        cause unreasonable effects to the environment, which is a 
        requirement of the registration standard under FIFRA;

   On July 2, 2013, the Pollinator Stewardship Council and 
        others, petitioned for review of the sulfoxaflor registration 
        in the Ninth Circuit Court of Appeals. On September 10, 2015, 
        the Court issued its opinion, finding that the registration was 
        not supported by substantial evidence to demonstrate no 
        unreasonable adverse effects to honey bees would result from 
        the registration of [sulfoxaflor]. Although the initial 
        sulfoxaflor submission contained all the data the EPA 
        determined was necessary by the EPA for registration of a new 
        agricultural insecticide, the Court vacated the registrations 
        and remanded them to the EPA to ``obtain further studies and 
        data regarding the effects of sulfoxaflor on bees as required 
        by the EPA regulations.'' The vacatur of the sulfoxaflor 
        registrations became effective November 12, 2015. As the 
        registrations were no longer in effect under FIFRA, on the same 
        date the EPA issued a cancellation order to address existing 
        stocks. Although the product registrations were vacated, the 
        tolerances for sulfoxaflor residues on treated commodities that 
        were established under the FFDCA, remain in place; and

   On March 4, 2016, the EPA issued a notice of intent to 
        cancel the registration of four pesticide products containing 
        the insecticide flubendiamide owing to the registrants' failure 
        to comply with a required condition of their registrations. The 
        particular condition obligated the registrants to request 
        cancellation if, after receiving additional required data, the 
        EPA determined that use of flubendiamide did not meet the FIFRA 
        standard for registration. Prior to issuing the notice, the EPA 
        concluded that the continued use of flubendiamide will result 
        in unreasonable adverse effects on the environment, 
        particularly benthic invertebrates, which are an important part 
        of the aquatic food chain, particularly for fish.

    Over the past 8 years, the EPA has issued a number of regulations 
with the intention of providing clarity to the regulated community and 
other stakeholders or to update information that has become inaccurate 
or out of date. Examples of these rulemaking efforts include:

   Minimum Risk (Published 12/28/2015): This final rule more 
        clearly describes the active and inert ingredients permitted in 
        products eligible for the exemption from regulation for minimum 
        risk pesticides. These changes maintain the availability of 
        minimum risk pesticide products while providing more consistent 
        information for consumers, clearer regulations for producers, 
        and easier identification by states, Tribes and the EPA as to 
        whether a product is in compliance with the exemption;

   Crop Grouping (Published Phase 1: 12/7/2007; Phase 2: 12/8/
        2010; Phase 3 8/22/2012; Phase 4: anticipated 2016): These 
        final rules are likely to reduce the number of residue 
        chemistry studies required to establish a tolerance for a crop 
        within these crop groupings because instead of testing each 
        crop individually, only the representative crops would need to 
        be tested. Thus, the new crop groups ease the process for an 
        entity to request and for the EPA to set pesticide tolerances 
        on greater numbers of crops. Pesticides will be more widely 
        available to growers for use on crops, particularly specialty 
        crops;

   Data Requirements for Antimicrobials (158W) (Published 5/8/
        2013): the EPA revised the data requirements for antimicrobial 
        pesticide products to reflect current scientific and regulatory 
        practice, and to provide the regulated community with clearer 
        and transparent information about the data needed to support 
        pesticide registration decisions for antimicrobial products. 
        The EPA would use this information to conduct risk assessments 
        for a particular pesticide;

   Prions as Pests (Published 2/28/2013): In 2003, the EPA 
        determined that a prion (proteinaceous infectious particles) is 
        a ``pest'' under FIFRA and that a product intended to reduce 
        the infectivity of prions on inanimate surfaces (i.e., ``prion 
        product'') is considered to be a pesticide. The EPA believes 
        that regulating prion-related products protects human health 
        and the environment against unreasonable adverse effects and 
        ensures that such products are effective;

   Export Labeling (Published 1/18/2013; Revisions Published 
        12/19/2014): the EPA revised the regulations pertaining to the 
        labeling of pesticide products and devices that are intended 
        solely for export. Pesticide products and devices intended 
        solely for export are now able to meet the agency's export 
        labeling requirements by attaching a label to the immediate 
        product container or by providing collateral labeling that is 
        either attached to the immediate product being exported or that 
        accompanies the shipping container of the product being 
        exported at all times when it is shipped or held for shipment 
        in the United States. Collateral labeling ensures the 
        availability of the required labeling information, while 
        allowing pesticide products and devices that are intended 
        solely for export to be labeled for use in, and consistent with 
        the applicable requirements of the importing country; and

   Data Compensation (Published 2/5/2014): the EPA revised its 
        regulations governing procedures for the satisfaction of data 
        requirements under FIFRA, which are codified in 40 CFR Part 
        152, subpart E. These provisions include, among other things, 
        procedures for the protection of exclusive use and data 
        compensation rights of data submitters. The EPA updated the 
        regulations to accommodate statutory changes and changes in 
        practice that have occurred since 1984; to make minor changes 
        to clarify the regulations; and to make changes that would 
        simplify the procedures and reduce burdens for certain data 
        submitters. The revisions did not otherwise make substantive 
        changes to the requirements.

    At times, however, the EPA has determined that significant changes 
to its regulations are needed to improve public health. For example, in 
November 2015, the EPA finalized revisions to the Agricultural Worker 
Protection Standard. This final rule revised the Federal regulations 
issued under FIFRA that direct agricultural worker protection (40 CFR 
Part 170). The changes reflected current research on how to mitigate 
occupational pesticide exposure to agricultural workers and pesticide 
handlers, and strengthened the protections provided to agricultural 
workers and handlers under the worker protection standard. The changes 
improved elements of the existing regulation, such as training, 
notification, communication materials, use of personal protective 
equipment, and decontamination supplies, thus preventing exposure to 
pesticides among agricultural workers and pesticide handlers; 
vulnerable groups, such as minority and low-income populations, child 
farmworkers, and farmworker families; and the general public. The EPA 
is working closely with affected stakeholders, including state 
agricultural agencies, to ensure that they have the necessary 
information and training to implement these new protections.
    Similarly, the EPA is now working to develop a final rule to revise 
the Federal regulations governing the certified pesticide applicator 
program (40 CFR Part 171). This action is intended to improve the 
competence of certified applicators of restricted use pesticides (RUPs) 
and to increase protection for noncertified applicators of RUPs 
operating under the direct supervision of a certified applicator 
through enhanced pesticide safety training and standards for 
supervision of noncertified applicators. State agricultural agencies, 
as well as many other stakeholders, provided valuable comments and 
suggestions in response to the EPA's proposed rule. We will work with 
stakeholders to ensure that the revised competency standards can be 
implemented effectively by state agencies.

    Question 29. Federal law includes very specific actions that a 
Federal agency must take before promulgating new regulations. The 
Office of Pesticide Programs has circumvented this process by sending 
pesticide registrants letters that outline new regulatory provisions. 
This ``regulation by letter'' procedure was used by EPA in 2013 to 
mandate registrants include pollinator statements and a graphic on 
certain products, and in 2009 for a labeling initiative. What is EPA's 
rationale for circumventing the Administrative Procedure Act (APA), 
which includes notice and comment, economic and small business impact 
analysis, etc.?
    Answer. The EPA does not ``regulate by letter'' and FIFRA does not 
provide for such a regulatory mechanism to make changes to pesticide 
registrations. The EPA pesticide program is a licensing program that is 
based on an adjudicatory system. As a licensing program, the agency 
must ensure that the license complies with the law and continues to 
comply with the law. As such, decisions to grant a new license or 
change/modify an existing license are not subject to APA rulemaking, 
but the procedural requirements of FIFRA. When the EPA receives new 
information and determines that the license may lead to unreasonable 
adverse effects on the environment, the agency may offer the registrant 
a way to correct the imbalance in a timely manner. The August 2013 
letter regarding labeling changes for the neonicotinoid insecticides is 
one example. However, if the registrant chooses not to address the 
concerns raised in such an offer, the agency can take appropriate steps 
under FIFRA to compel any necessary changes to the pesticide 
registration to mitigate unreasonable adverse effects on the 
environment. The letter itself is not self implementing; in the absence 
of voluntary agreement from a registrant, FIFRA prescribes steps that 
the agency must take to impose new mitigation measures.

    Question 30. EPA's honeybee acute toxicity proposal would restrict 
approved crop protection tools from use when a grower is under a 
pollination contract. The proposal clearly did not have the support of 
conventional or organic growers, or the national beekeeper 
organizations, or the USDA, which sent a letter to the Agency 
criticizing the proposal. Honeybees are not native species; they are 
essentially livestock and the property of the beekeeper. Why is EPA 
attempting to regulate contracts between private parties? Has the 
Agency produced an analysis to show the benefit expected if the rule is 
implemented?
    Answer. With greater attention put on protecting pollinators as 
well as their important role in agricultural production, the EPA's 
acute mitigation strategy, EPA's Proposal to Mitigate Exposure to Bees 
from Acutely Toxic Pesticide Products, is aimed at providing greater 
protection to bees where acute risk is presumed to be the highest, 
namely when nearly certain exposure (i.e., contract pollination 
scenarios) and presence of an acutely toxic pesticide coincide. The 
intent of the proposed acute mitigation strategy is to protect managed 
(contracted) bees at commercial pollination sites, and also likely 
provide protection for other pollinators near the treatment area.
    The proposed approach is to clarify and strengthen the existing 
language for the acutely toxic compounds in the immediate term. The 
agency will also assess each compound under the registration review 
program, with a robust data set identified in our Risk Assessment 
Framework for Pollinators that also evaluates potential sub-lethal and 
chronic impacts to pollinators at both the individual and colony level. 
As a result, chemical-specific, risk based labeling will be developed. 
As part of its planning and analysis prior to issuing its proposal, the 
agency did consider the potential cost to growers.
    The EPA is currently reviewing the wide range of comments it 
received in response to the proposal. Based upon comments received, we 
are developing options on moving forward. While doing so, the agency 
will continue to weigh both the level of protection to bees, and the 
potential impact to growers.

    Question 31. Environmental activists recently sued the EPA claiming 
that the Agency should regulate seeds treated with systemic pesticides 
as pesticides themselves and regulate those seeds under FIFRA. Congress 
has expressed its intent that seeds are not subject to the same 
regulatory requirements as applied pesticides, and in recent years has 
found that treated seeds are safe and offer significant value to 
farmers, which is consistent with EPA's long-held view. Furthermore, 
restricting seed treatments would likely lead to them being replaced 
with spray or soil applications and that switch would not result in 
improved environmental protection. Do you intend to vigorously defend 
the Agency's determination that economically-beneficial coated seeds 
are ``treated articles''?
    Answer. With respect to the litigation filed by public interest 
groups, on March 14, 2016, the EPA filed a motion with the district 
court in the Northern District of California to dismiss the case 
against the EPA. A hearing on this motion was held on May 12, 2016, and 
the following day the court issued an order deferring a decision on the 
merits of the EPA's motion to dismiss until the EPA produced an 
administrative record. The EPA has complied with the court's order and 
expects the court to address its jurisdiction (the subject of the 
motion to dismiss) during summary judgment proceedings. Under the 
current litigation schedule, summary judgment motions are to be filed 
in September and should be argued in October 2016.

    Question 32. Seed treatments deliver a very precise application 
that shields seeds from the insects and diseases that exist in the soil 
during early developmental stages. Do you agree that seed treatments 
reduce the environmental impact of the production process by decreasing 
the number of spray applications of agrichemical products lessening 
exposure to non-target species, including humans, pollinators and the 
environment?
    Answer. In general, the EPA agrees that seed treatments are 
effective at reducing environmental exposure and impact, as compared to 
spray applications of agrichemical foliar products, to humans and the 
environment. In addition, the EPA has engaged in discussions with the 
American Seed Trade Association, equipment manufacturers, and pesticide 
registrants to encourage broader adoption of best management practices 
intended to reduce the potential for drift of contaminated dust during 
the planting of pesticide-coated seeds that have resulted in incidents 
to honeybees. These efforts have included the development of 
alternative lubricants used in pneumatic planters to reduce dust 
generated through the abrasion of treated seed during planting as well 
as the development of more effective seed coatings to enhance pesticide 
adherence to the seed.

    Question 33. When this Committee passed both H.R. 872 in the 113th 
Congress and H.R. 897 last year we discussed the outbreaks of West Nile 
Virus and even concerns about Malaria across many regions of the 
country. Today, there is a new threat to human health called the Zika 
virus, which is also transmitted through mosquitos. The World Health 
Organization has gone so far as to declare a public health emergency of 
international concern. There are no vaccines or a reliable diagnostic 
test. I believe that America will be better adept to combat the spread 
of the virus with our world renowned researchers and response by the 
public health community. However, our country is currently being 
hamstrung by an ill-advised court decision that was in contradiction 
with EPA's own assessment under the Clean Water Act and the Federal 
Insecticide, Fungicide, and Rodenticide Act. In some states, the burden 
and liabilities of obtaining a duplicative NPDES permit are limiting or 
delaying mosquito control applications that protect human health. Will 
the Administration support the passage of this important legislation?
    Answer. The Administration believes that legislation removing CWA 
Act protections for public health and water quality is not the answer 
for effective and timely action to respond to the threat of mosquito-
borne illness.

    Question 34. Major farm organizations have written EPA concerning 
the need for new, effective weed management tools. Prominent academics, 
farm group leaders and many others have said multiple modes of action 
are the most effective way to deal with weed resistance issues while 
preserving environmentally beneficial cropping systems like no-till or 
conservation tillage. Yet when it comes to crop protection product 
registrations at EPA, some innovative products that can help growers 
meet these goals have been either sitting at your Agency for several 
years, or in some cases courts have intervened to vacate registrations. 
What conversations are you having with USDA and the industry to 
minimize the concerns raised in court actions and to ensure the near-
term availability of new, more effective weed management chemistries?
    Answer. The EPA recognizes the negative impacts of weed resistance 
and understands the needs of growers for new weed control technology. 
The EPA's review of herbicides proposed for use on genetically modified 
seed requires thorough and scientifically rigorous assessments for both 
human health and the environment. The agency has intensified 
communications and information sharing with USDA in handling these 
actions, and is building a framework for a streamlined process that 
also addresses new measures for avoiding the onset of new resistance 
issues.
    Because the emergence of herbicide resistance is an increasing 
problem in the United States, the EPA has been working directly with 
the USDA and industry to construct a comprehensive resistance 
management program. By developing these new strategies, the EPA hopes 
to promote a more efficient registration process while simultaneously 
preserving the longevity of important new herbicide tools. Meanwhile, 
the agency will continue to work closely with the USDA in the review of 
herbicides submitted in association with herbicide-tolerant traits to 
ensure that our two agencies perform a thorough scientific review of 
the potential impacts on human health and the environment associated 
with the proposed use of additional herbicides on herbicide-tolerant 
crops.
    In addition, in the spring of 2016, the EPA requested public 
comment on two Pesticide Registration Notices (PRNs) that focus on 
strategies to combat or slow pesticide resistance, and preserve the 
useful life of pesticide chemistries. One of these PRNs aims to improve 
resistance management information contained on the labels of all 
conventional pesticide products.\1\ The other PRN focuses on the 
agency's proposed strategy for addressing herbicide resistance.\2\ The 
EPA expects to finalize these two PRNS in late 2016.
---------------------------------------------------------------------------
    \1\ https://www.epa.gov/pesticide-registration/prn-2016-x-draft-
guidance-pesticide-registrants-pesticide-resistance.
    \2\ https://www.epa.gov/pesticide-registration/prn-2016-xx-draft-
guidance-herbicide-resistance-management-labeling-education.

    Question 35. EPA recently asked the 9th Circuit Court of Appeals to 
remand a pesticide registration back to EPA for further review because 
of concerns under the Endangered Species Act. This is the only time 
ever where EPA has attempted to vacate a pesticide registration through 
a court action. Currently under FIFRA, EPA is required to comply with a 
number of procedural safeguards before a pesticide registration can be 
canceled, which they have failed to do. What was the Agency rationale 
for taking such an unusual step of asking a Court to require EPA to 
review the registration of a product so recently approved for use and 
why is the Agency now trying to use the Courts as a means to regulate?
    Answer. The EPA felt compelled to seek remand and vacatur because 
the EPA discovered, after granting the registration for Enlist Duo, 
that Dow had made claims of ``synergistic herbicidal weed control'' in 
its Provisional and Non-provisional patent applications to the U.S. 
Patent and Trademark Office for Enlist Duo. This new information 
suggests the two active ingredients used in combination could result in 
greater toxicity to non-target plants than believed by the EPA at the 
time the agency granted the registration. This information was not 
provided to the EPA by Dow prior to the EPA issuing the Enlist Duo 
registration. This new information could lead the EPA to a different 
decision on the restrictions on use of Enlist Duo, including those 
necessary to ensure the protection of listed species in the context of 
the Endangered Species Act.
    Because the EPA had become aware of previously existing information 
about possible synergistic effects that it did not consider, the agency 
could no longer represent to the Court that its conclusions were 
correct regarding whether issuance of the registration met the standard 
in FIFRA and whether the buffer zones included in the registration 
support the finding that the registration will have no effect upon 
threatened or endangered plant species. The EPA therefore sought from 
the Court an order of remand with vacatur.

    Question 36. The United States has the world's most rigorous 
pesticide registration and review processes. We regulate pesticide by 
assessing `risk' to determine whether and how a product can be used 
safely. In evaluating risk, `hazard' (whether something can cause harm) 
and `exposure' (whether something you'll be exposed to harm) are 
balanced against the benefits of using a product. This is something EPA 
should be confident in and proud to defend. As a matter of fact, EPA 
does a great job defending the merits of our risk-based system when 
commenting on the EU's precaution-based regulatory scheme. But, 
recently it seems when EPA regulatory decisions are challenged in the 
U.S., you seem reluctant to defend or, even more troubling, unable to 
properly provide evidence of the Agency's scientific decisions. How can 
you better inform the public and skeptics that the products EPA 
registers are thoroughly tested and protective of human health, 
vulnerable species and the environment?
    Answer. The EPA agrees that it has one of the world's most rigorous 
registration and reevaluation processes. The agency always strives to 
base its decisions on the best available science. However, science is 
constantly evolving, and new scientific information can come to light 
at any time and change our understanding of potential risks from 
pesticides. If any pesticide is found to present risks to human health 
or the environment that cannot be mitigated or managed through other 
measures, the agency has to make a finding that the pesticide no longer 
meets the FIFRA standard for registration or under the Federal Food, 
Drug, and Cosmetic Act for pesticide tolerances. In that case, then the 
agency will move quickly to take appropriate regulatory action. Any 
such action, however, would have to be supported by the best available, 
peer-reviewed science. The EPA scientific assessment approaches are 
publicly available at http://www2.epa.gov//pesticide-registration/
understanding-science-behind-epas-pesticide-decisions [See Attachment 
4].

    Question 37. There have been several instances where courts, local 
governments or other organizations have challenged EPA regulatory 
decisions. What can Congress do to educate the public, localities, 
courts and other institutions about the rigors of the pesticide 
registration process and to increase the public's confidence in EPA's 
pesticide registration decisions?
    Answer. As stated in the response above, the EPA agrees that it has 
one of the world's most rigorous registration and reevaluation 
processes. The agency always strives to base its decisions on the best 
available science. In addition, the EPA believes that by makings its 
decisions in a transparent manner, including through the active 
solicitation of public participation in the process, we demonstrate the 
scientific soundness of our decisions.

    Question 38. The Committee has heard about a serious matter 
regarding EPA policies based on human research data that may not be 
reliable. For years, EPA relied on hundreds of quality studies 
evaluating all aspects human susceptibility to pesticides called 
organophosphates--otherwise known as OP's. These included studies 
designed to make sure that children would be protected. Even though EPA 
used those high-quality assessments for 20 years; EPA now relies 
primarily on three epidemiology publications and some journal articles 
in which EPA, I am told, EPA does not have access the raw data to 
determine if these studies are reliable or accurate. The Committee has 
been advised that Columbia University--who conducted the key study--
refused to provide the raw data to EPA even though EPA provided funding 
for the study. So, it appears EPA is relying on information based on 
raw data that cannot be reviewed for accuracy. If it is correct that 
EPA has not gotten access to that raw data, Federal regulations 
designed to enhance the credibility of the Federal rulemaking process 
have likely been violated. Data Quality Act violations and conflict of 
interest violations could have also occurred.
    EPA held a meeting in May 2013 with researchers from Columbia 
University about the Columbia Study. Is there a transcript of the 
discussion that took place at that meeting? Were minutes taken at the 
meeting and made available?
    Answer. The agency wrote a summary of the 2013 meeting with 
researchers from Columbia University. This summary is contained in 
``Appendix 6 Columbia Center for Children's Environmental Health 
(CCCEH) Epidemiology Data Acquisition `Raw Data Request' '' of EPA's 
December, 2014 human health risk assessment for chlorpyrifos which can 
be found at www.regulations.gov in docket ID number: EPA-HQ-OPP-2008-
0850-0195, (Drew, et al., D424485, December 29, 2014) [See Attachment 
5].

    Question 38a. Did the Federal Government provide any funding for 
any or all of the three epidemiology studies, most notably the study 
from Columbia University's Center for Children's Health commonly 
referred to as the Columbia Study, the ``CHAMCOS'' study and, also, the 
Mt. Sinai study which were relied upon by the Agency to raise issue 
about potential effects on infants and children in the human health 
assessment and Proposed Rule to revoke tolerances for chlorpyrifos? 
Please provide details on any and all funding EPA provided for any 
portion of the three studies.
    If yes:
    Question 38a. (Yes i.) Does the Agency have in its possession all 
the raw data from the studies? (Raw data would include but is not 
limited to interview data with participants, blood and urine analysis, 
interviews with the children, etc.)

    Question 38a. (Yes ii.) For which of these studies does EPA possess 
the raw data?

    Question 38a. (Yes iii.) Why have the data not been made available 
to registrants affected by the Agency's actions or in response to FOIA 
requests?

    If no:
    Question 38a. (No i.) Why not? How does this lack of possession and 
lack of availability of the data not conflict with the 2009 
Presidential memorandum which says that if scientific and technical 
information is developed and used by the Federal Government, it should 
ordinarily be made available to the public? [``. . . mandating 
disclosure of scientific and technical information developed and used 
by the Federal Government.''] Why is the Agency not complying then with 
the goal of that memorandum for transparency in the use of scientific 
information in policy making?

    Question 38a. (No ii.) How can EPA say that its use of epidemiology 
data for chlorpyrifos is transparent when the Agency did not obtain and 
consider the underlying raw data for the studies it relied upon or 
provide minutes from the meeting with the researchers?

    Question 38a. (No iii.) Without the raw data, how can the Agency 
confirm there is no negative data, null results or confounding factors 
that would have changed the Agency's conclusions about the studies? How 
is such a decision consistent with EPA's reliance for chlorpyrifos risk 
assessment purposes on epidemiology studies for which the Agency cannot 
obtain and consider the raw data?

    Question 38a. (No iv.) EPA says that it is relying on 
``uncertainty'' created by the epidemiology studies to set the FQPA 
additional safety factor for chlorpyrifos. But hasn't EPA created this 
uncertainty by failing to obtain and consider the raw data for the 
epidemiology studies the Agency is relying upon?

    Combined answer. The EPA provided funding for the Columbia Center 
for Children's Environmental Health (CCCEH), the Mount Sinai Center for 
Children's Environmental Health and Disease Prevention Research, and 
Center for the Health Assessment of Mothers and Children of Salinas 
(CHAMACOS) cohort at the Center for Environmental Research and 
Children's Health (CERCH). The EPA and the National Institute of 
Environmental Health Sciences (NIEHS) jointly provided funding to the 
CCCEH under the 1997 and 2003 Request for Applications (RFAs). The 
approximate EPA funding for the 5 year CCCEH awards was $3.9 million 
under the 1997 RFA (matched by NIEHS) and $3.6 million under the 2003 
RFA (NIEHS provided $3.5 million).
    Similarly, the EPA and the NIEHS jointly provided funding to the 
Mount Sinai Center for Children's Environmental Health and Disease 
Prevention Research under the 1997 and 2003 RFAs. The approximate EPA 
funding for the 5 year Center awards was $3.9 million under the 1997 
RFA and $4.0 million under the 2003 RFA (matched by the NIEHS with $4.1 
million under the 1997 RFA and $3.8 million under the 2003 RFA).
    The EPA and the NIEHS also jointly provided funding to the CERCH 
under the 1997, 2003, and 2009 RFAs. The approximate EPA funding for 
the 5 year Center awards was $4.5 million under the 1997 RFA (NIEHS 
provided $4.2 million), $3.6 million under the 2003 RFA (NIEHS provided 
$3.3 million), and $3.6 million under the 2009 FRA (NIEHS provided $4.2 
million).
    In the summer of 2015, Dr. Dana Barr of Emory University provided 
the agency with limited raw urine and blood data in her possession from 
the three cohorts. However, the files provided from Dr. Barr are not 
useful for the agency's current purpose of assessing risk to 
chlorpyrifos. The files provided from Dr. Barr do not contain the 
biomonitoring data from the key publications from CCCEH which describe 
associations between blood levels of chlorpyrifos and 
neurodevelopmental deficits in children. The EPA does not have any of 
the other measurements of the children in the cohort (e.g., 
chlorpyrifos blood data, interviews, test or IQ scores). The CCCEH 
researchers have not provided these data, asserting that the pesticide 
component of the cohort study was privately funded, not federally 
funded, and therefore disclosure of underlying data is not required. 
The agency received two FOIA requests specifically asking for raw data 
on the three U.S. children's cohorts. For the first FOIA request, EPA-
HQ-2016-002089, the requester was provided all the responsive records 
(i.e., the files provided by Dr. Barr) and the request was closed March 
2, 2016. For the second request, EPA-HQ-2016-003947, the agency did not 
have any additional files beyond those provided for the first request. 
The second FOIA was closed on March 23, 2016.
    While the EPA strives to ensure that data underlying research it 
relies upon are accessible to the extent possible, it does not believe 
that it is appropriate to refuse to consider published studies in the 
absence of underlying data. The EPA frequently relies on peer reviewed 
studies in the public literature across agency programs without 
possessing underlying data and the Federal courts have made clear that 
the EPA is not required to obtain or analyze the raw data in order to 
rely on such studies. If the EPA and other governmental agencies could 
not rely on published studies without conducting independent analyses 
of the raw data underlying them, then much relevant scientific 
information would become unavailable for use in setting standards to 
protect public health and the environment.
    In the past, the EPA sought to obtain the original raw data used to 
support certain epidemiological analysis of in utero exposure to 
chlorpyrifos and subsequent adverse neurodevelopmental health outcomes 
in children generated by the CCCEH to support the human health risk 
assessment of chlorpyrifos. Prior to the 2013 meeting with CCCEH 
investigators, the EPA thought these data would be important to both 
clarify the exposure-response relationship observed in the epidemiology 
study relative to the current regulatory endpoint (acetylcholinesterase 
inhibition), and also to resolve uncertainties regarding study 
participants co-exposure to other environmental contaminants, among 
other areas of uncertainties. CCCEH researchers did not agree to 
provide these data; however, the researchers met with the EPA and 
discussed the agency's questions about the data to help determine 
whether further review of the raw data might assist the EPA in 
resolving uncertainties. As a result of this meeting, the EPA concluded 
that access to the raw data would not provide answers to the EPA's 
questions. Indeed, based on discussions in that meeting as well as 
further work conducted by agency staff, the EPA has gained additional 
information to better clarify and characterize the major issue areas 
identified as uncertainties.
    In the summer of 2015, the EPA again requested the raw data from 
Columbia University. The Columbia University investigators again denied 
the EPA's request. However, the investigators did provide additional 
summary information on the blood biomonitoring data. The agency has 
made this additional information publicly available. The EPA continues 
to engage with Columbia University on this topic.

    Question 39. Related to the use of these epidemiology studies, in 
2011, EPA said that it was reviewing a Scientific Advisory Panel report 
regarding the Agency's Draft Epidemiology Framework and would, also 
during 2011, release a revised version of the framework for public 
comment.
    Why has the Agency not completed this task?

    Question 39a. How can the Agency's reliance on the Draft 
Epidemiology Framework to integrate the epidemiology studies into the 
risk assessment for chlorpyrifos be reasonable when, contrary to EPA's 
promise, the framework has not been revised consistent with SAP 
recommendations and made available for public comment?
    Answer 39-39a. Although use of epidemiology is common in other 
agency regulatory programs, epidemiology studies focusing on pesticides 
have only become available in the last few years. Thus, epidemiology 
data are less frequently used in evaluation of pesticides. The EPA 
decided that additional experience was needed in applying the ``Draft 
Framework for Incorporating Human Epidemiologic & Incident Data in 
Health Risk Assessment'' prior to its finalization. Obtaining such 
experience is consistent with the recommendations of the Federal 
Insecticide, Fungicide, and Rodenticide Act Science Advisory Panel 
(FIFRA SAP) (2010) to ``conduct a broader analysis'' to improve the 
written description of the process of integration of epidemiology with 
other lines such as animal toxicity data. The ongoing work on 
chlorpyrifos and the organophosphates are examples of such experience. 
The FIFRA SAP commended the agency for developing the draft Framework 
and was ``impressed with the documentation presented.'' The agency also 
notes that the FIFRA SAP was supportive of the key components of the 
draft Framework, namely the use of problem formulation to assess data 
availability and quality early in the process and the modified Bradford 
Hill criteria as an internationally accepted tool for assessing 
epidemiology and laboratory animal data. Because the FIFRA SAP was 
basically supportive of the overall approach, the agency believes use 
of the draft Framework in its current form is appropriate prior to the 
finalization of the document.

    Question 39b. What are the number and total cost of all of the 
animal studies conducted by registrants that EPA has required and/or 
evaluated over the years to assess the potential toxicity and health 
risks of the OP pesticides, for which the proposed reliance on the 
three controversial epidemiology studies would trump, invalidate, or 
dismiss all of the animal study results?
    Answer. The EPA has established data requirements (40 CFR) so that 
the agency can conduct appropriate risk assessments, including risks to 
human health. The relevant studies are associated with the 
toxicological data requirements for a food use. There are generally 30 
studies that may be required but some pesticides may have more studies 
and some may have fewer. The organophosphate (OP) pesticides typically 
have completed all of the required studies since their initial 
registration, through reregistration, and to date during registration 
review. The EPA does not know the cost of generating these data for any 
particular company or chemical.
    The agency has not limited the number of studies reviewed to the 
three epidemiology cohorts. In fact, the agency has reviewed hundreds 
of studies from laboratory animals, cell systems (including human), 
biomonitoring, and epidemiology on a variety of scientific areas 
related to human health effects. These studies were evaluated together 
in a weight of evidence analysis.

    Question 39c. What is the biological mechanism of toxicity that 
accounts for supposed differences between the controversial 
epidemiology studies and the mountain of reliable data from animal 
toxicology studies? What is the biological plausibility of the results 
observed and any conjectured mechanisms of action? What are all of the 
possible confounding factors that could affect, influence, or produce 
the results observed, and how have they been accounted for in the 
reports that EPA has relied on? Who/what is/are the unexposed cohort 
that shows that the effects allegedly found in the controversial 
epidemiology studies could reasonably be attributable to pesticide 
exposure?
    Answer. The EPA conducted detailed evaluations of the scientific 
literature on the neurodevelopmental potential of chlorpyrifos and 
other OPs as part of reviews by the FIFRA SAP in 2008 and 2012 along 
with the 2014 human health risk assessment for chlorpyrifos and the 
2015 literature review for all the OPs. This includes review of 
registrant submitted studies along with studies from the scientific 
literature. Biological plausibility of the findings from the 
epidemiology studies are found in numerous studies conducted in 
laboratory animals and using new technologies, including human cells. 
There are a large number of animal studies using rats and mice from a 
dozen laboratories worldwide which have reported neurodevelopmental 
effects in offspring exposed to chlorpyrifos in the womb or after 
birth. Some in vitro studies, like those recommended by the NAS in the 
2007 report on Toxicity in the 21st Century, conducted at very low 
concentrations have suggested several biological mechanisms which could 
underlie effects at low exposure levels as seen in the epidemiological 
studies.
    These studies present strong evidence that developmental 
neurotoxicity of chlorpyrifos and other OPs may not be due to 
acetylcholinesterase inhibition per se, but to other actions on 
critical aspects of neuronal development. There are a number of 
biologically plausible molecular events proposed for chlorpyrifos and 
other OPs effects on the developing nervous system, with ongoing 
academic research pursuing many of these potential pathways. Some of 
the more promising mechanisms represent molecular initiating events 
(binding to the morphogenic site of AChE, muscarinic receptors, or 
tubulin), cellular responses (alterations in neuronal proliferation, 
differentiation, neurite growth, or intracellular signaling) and 
responses at the level of the intact nervous system (serotonergic tone, 
axonal transport). Overall, there is good evidence that 
neurodevelopmental effects may not be solely a function of 
acetylcholinesterase inhibition.
    The EPA is including epidemiologic research results from three 
prospective birth cohort studies. These include: (1) The Mothers and 
Newborn Study of North Manhattan and South Bronx performed by the 
Columbia Children's Center for Environmental Health (CCCEH) at Columbia 
University; (2) the Mt. Sinai Inner-City Toxicants, Child Growth and 
Development Study or the ``Mt. Sinai Child Growth and Development 
Study;'' and (3) the Center for Health Assessment of Mothers and 
Children of Salinas Valley (CHAMACOS) conducted by researchers at 
University of California, Berkeley.
    In these epidemiology studies, mother-infant pairs were recruited 
for the purpose of studying the potential health effects of 
environmental exposures during pregnancy on subsequent child 
development. Each of these cohorts evaluated the association between 
prenatal chlorpyrifos or OPs exposure with adverse neurodevelopmental 
outcomes in children through age 7 years and to limited extent up to 11 
years old. The CCCEH Mother's and Newborn study and the Mt. Sinai Child 
Growth and Development study participants were likely exposed to 
chlorpyrifos and other OPs through the diet and through residential use 
of the pesticide for indoor pest control. The CHAMACOS cohort 
participants were employed as farm laborers or were residing in homes 
with farm laborers. The CHAMACOS study participants likely experienced 
exposure to OPs through the diet and from occupational exposure 
(primarily inhalation and dermal routes), as well as probable indirect 
take-home exposures.
    Biomonitoring data were collected from individuals within each 
cohort. The unexposed children in the epidemiology studies are those 
whose biomonitoring data are low and often below the limit of 
detection, i.e., so low as to not be measurable. The unexposed children 
are derived from the same populations and location in the same living 
and economic conditions as the exposed or highly exposed children. In 
this way, important issues such as socioeconomic status are similar 
across the entire group of exposed and unexposed.
    The EPA focused its review on research results from these three 
epidemiological cohort studies due to the considerable strengths in 
study design, conduct, and analyses. Investigators from each study 
cohort utilized a strong study design (prospective birth cohort), 
measured pesticide exposure using several different methods including 
biomarkers, and measured neurodevelopment effects in children using 
well-established assessment tools in both clinical and research 
settings. In addition, the investigators have accounted for potentially 
confounding variables including socioeconomic status and other 
environmental exposures. Evaluation of these confounding variables is 
important to reduce the chances of a false positive study result. 
Across these cohort studies, investigators collected relevant 
information on demographic characteristics and other environmental 
exposures and used this information in the statistical analysis. Other 
environmental exposures considered by the investigators were blood 
lead, environmental tobacco smoke, polyaromatic hydrocarbons (PAHs), 
methylmercury, or other non-OPs. The EPA and the FIFRA SAP (2008 and 
2012) believe that the cohort study authors were able to appropriately 
measure and model the effect of potential confounding variables on the 
study outcomes.
    The agency held another meeting of the FIFRA SAP on April 19-21, 
2016 to review a new analysis using the blood biomonitoring data from 
the Columbia University epidemiology study.

    Question 39d. Given the pesticide uses registered today, what is 
the relevance of the pesticide exposures that allegedly caused effects 
observed in the controversial epidemiology studies to the current 
regulatory picture?
    Answer. Agricultural use of OPs remain today for many crops across 
the United States. Agricultural workers (including women who may be 
pregnant) who mix, load, and/or apply pesticides, as well as those who 
work in previously treated fields (e.g., harvesting citrus fruit) are 
exposed to high levels of OPs. In addition, some areas of the country 
are predicted to have OPs or their more toxic degradates in drinking 
water. Exposure to OPs through food to the entire country is also 
expected.

    Question 39e. Please explain in layman's terms the process for 
``Systematic Review of scientific literature for laboratory animal 
studies & epidemiology studies'' used by the Agency. How does this 
differ from the Agency's review of studies and data it requires 
registrants to conduct and submit in support of pesticide 
registrations? How do the two processes supplement, complement, or 
contradict each other?
[http://www.epa.gov/sites/production/files/2015-10/documents/op-risk-
assessment-approach.pdf. Also https://ntp.niehs.nih.gov/pubhealth/hat/
noms/index-2.html.]
    Answer. In recent years, the National Academies' National Research 
Council (NRC) has encouraged the agency to move towards systematic 
review processes to enhance the transparency of scientific literature 
reviews that support chemical-specific risk assessments to inform 
regulatory decision making (NRC 2011, 2014). The NRC defines systematic 
review as ``a scientific investigation that focuses on a specific 
question and uses explicit, pre-specified scientific methods to 
identify, select, assess, and summarize the findings of similar but 
separate studies'' (NRC 2014). According to the NRC, systematic reviews 
``have several common elements: transparent and explicitly documented 
methods, consistent and critical evaluation of all relevant literature, 
application of a standardized approach for grading the strength of 
evidence, and clear and consistent summative language.''
    The EPA's approach to reviewing scientific data include: data 
collection, data review, and integration procedures. Therefore, the 
agency's standard review approaches for assessing toxicology data 
submitted by registrants and for integrating the registrant supported 
data with information from the open literature are consistent with the 
NRC's recommendations for systematic review. As such, although the 
terminology may differ, the approaches are consistent and similar.

    Question 39f. With such a requirement for an extensive base of 
these studies, how, according to your own Framework, does the Agency 
weigh an epidemiology study that is not conducted to the same standards 
as that required for a registrant study and where you do not even have 
in your possession the raw data?
    Answer. Most laboratory animal studies submitted to the agency by 
the registrants follow the EPA and Organisation for Economic Co-
operation and Development (OECD) guidelines and thus have specific and 
defined study designs. Epidemiology studies do not have such OECD 
guidelines; moreover, epidemiology studies can vary significantly in 
their study design.
    The EPA developed a ``Draft Framework for Incorporating Human 
Epidemiologic & Incident Data in Health Risk Assessment'' in 2010 which 
was reviewed by the FIFRA SAP and received public comment. The Panel 
commended the agency for developing the draft Framework and was 
``impressed with the documentation presented.'' The agency also notes 
that the Panel was supportive of the key components of the draft 
Framework, namely the use of problem formulation to assess data 
availability and quality early in the process and the modified Bradford 
Hill criteria as an internationally accepted tool for assessing 
epidemiology and laboratory animal data.
    In the draft Framework, the agency describes several areas for 
consideration of the quality of epidemiology studies: exposure 
assessment, confounding factors, statistical analysis, potential bias 
in observational research, interpretation of null studies, external 
validity (generalizability). The SAP concurred with these identified 
scientific areas for consideration and suggested additional ones 
including sample size and associated statistical power, and outcome 
assessment. The EPA has assessed all of these considerations as part of 
the evaluation for chlorpyrifos and the OPs. The EPA focused its review 
for OPs on research results from the three epidemiological cohort 
studies due to the considerable strengths in study design, conduct, and 
analyses demonstrated in these investigations. Investigators from each 
study cohort utilized a similarly strong study design (prospective 
birth cohort); measured pesticide exposure using several different 
methods including environmental indicators as well as specific and non-
specific biomarkers of chlorpyrifos; ascertained developmental outcomes 
using validated assessment tools well-established in both clinical and 
research settings; and, measured, analyzed, selected and statistically 
adjusted for potentially confounding variables including socioeconomic 
status and other environmental exposures using reasonable and 
appropriate methods.
    The EPA believes the draft framework is consistent with updates to 
the World Health Organization/International Programme on Chemical 
Safety mode of action/human relevance framework, which highlight the 
importance of problem formulation and the need to integrate information 
at different levels of biological organization. Similarly, the EPA's 
draft Framework is consistent with recommendations from the NRC in its 
2009 report on Science and Decisions \3\ * that describes the 
importance of using problem formulation at the beginning of a complex 
scientific analysis.
---------------------------------------------------------------------------
    \3\ NRC (National Research Council). (2009). Science and decisions: 
Advancing risk assessment. Washington, D.C.: The National Academies 
Press. http://www.nap.edu/openbook.php?record_id=12209.
    * Editor's note: the document referred to is retained in Committee 
file.

    Question 39g. From 1996 when FQPA was enacted through the current 
date, EPA has made multiple, specific formal findings based on 
extensive reliable databases that FQPA safety factors for OP 
insecticides can be reduced or eliminated. The Agency has proceeded to 
regulate the uses of these pesticides in the marketplace on that basis, 
and has therefore determined that the residue tolerances are safe. 
FFDCA  408(b)(2)(A)(1) requires the Administrator to ``. . . modify or 
revoke a tolerance if the Administrator determines it is not safe.'' 
What specific determination have you now made that the chlorpyrifos 
tolerances are ``not safe''?
    Answer. The EPA periodically reviews existing registered pesticides 
to ensure they can be used safely, without unreasonable risks to human 
health and the environment. The periodic review of pesticide 
registrations is required by FIFRA. The registration review program is 
intended to make sure that, as the ability to assess risk evolves and 
as policies and practices change, all registered pesticides continue to 
meet the statutory standard of no unreasonable adverse effects. The EPA 
will review each registered pesticide at least every 15 years to 
determine whether it continues to meet the FIFRA standard for 
registration.
    As part of registration review, the EPA assesses any changes that 
have occurred since the last registration decision to determine whether 
the pesticide still satisfies the statutory standard for registration. 
The EPA considers any new data or information on the pesticide and 
decides whether a new risk assessment must be conducted. In the case of 
chlorpyrifos and the OPs, many of the epidemiology studies, mechanistic 
studies, and laboratory animal studies on the neurodevelopmental 
effects of OPs were published after reregistration was completed in 
2006. As such, there is significant new information relevant to the 
human health effects of this group of pesticides which require a re-
analysis of scientific information relevant for the FQPA Safety Factor.
    As section 408(b)(2)(C) of the FFDCA instructs the EPA, in making 
its ``reasonable certainty of no harm'' finding, that in ``the case of 
threshold effects, an additional tenfold margin of safety for the 
pesticide chemical residue and other sources of exposure shall be 
applied for infants and children to take into account potential pre- 
and postnatal toxicity and completeness of data with respect to 
exposure and toxicity to infants and children.'' Section 408(b)(2)(C) 
further states that ``the Administrator may use a different margin of 
safety for the pesticide chemical residue only if, on the basis of 
reliable data, such margin will be safe for infants and children.'' 
Given the totality of the evidence, there is sufficient uncertainty in 
the human dose-response relationship for neurodevelopmental effects 
which prevents the agency from reducing or removing the statutory 10X 
FQPA Safety Factor.

    Question 40. For the chlorpyrifos risk assessment, the Office of 
Pesticide Programs conducted a highly refined dietary assessment for 
possible residues on food and found no risks of concerns. Why then does 
the Agency rely on only an unrefined, screening level assessment to 
claim risks from drinking water as the basis for the Proposed Rule?
    Answer. The December 2014 drinking water assessment conducted by 
the EPA is a refined, higher tier assessment that examined potential 
exposure to chlorpyrifos and its transformation product, chlorpyrifos-
oxon, at a national and a regional scale in order to locate where 
concentrations in drinking water may be of concern. The assessment 
followed a tiered approach, investigating not only maximum pesticide 
label rates, but also lower rates to identify uses and watersheds that 
would not be expected to be problematic. The uses that exceeded the 
drinking water level of concern in the regional analysis were further 
explored, e.g., evaluating exposure on a watershed basis. This ``proof 
of concept'' example showed an overlap of potential chlorpyrifos use 
sites that may result in an exceedance of the drinking water level of 
concern with watersheds that supply source water for community drinking 
water systems. The exercise demonstrated that chlorpyrifos applications 
result in variable drinking water exposures that are highly localized 
and that the highest exposures generally occur in small hydrologic 
regions where there is a high percent cropped area on which 
chlorpyrifos use could occur.
    The EPA finished a regional analysis for two regions of the 
country, the Pacific Northwest and South Atlantic-Gulf, to demonstrate 
the feasibility of this methodology and to solicit public comment on 
the approach. The EPA is currently finalizing the regional assessment 
for the remaining regions of the United States. In addition to the 
refined spatial scale at which the analysis was completed, two 
additional aspects of this drinking water assessment that contribute to 
its complexity and sophistication are the incorporation of surface 
water monitoring data and drinking water treatment effects. Results of 
surface water monitoring are presented and compared to model-estimated 
concentrations. This analysis showed that when modeling scenarios are 
parameterized to reflect reported use and estimated drinking water 
concentrations are adjusted to reflect percent cropped area, the 
estimated modeled concentrations are within an order of magnitude of 
the measured concentrations reported in the monitoring data. Finally, 
typical water treatment processes were considered in predicting 
residues in finished drinking water.

    Question 41. The EPA has stated that its drinking water assessment 
for chlorpyrifos is incomplete. Has the Agency ever before based a 
proposed tolerance revocation on an incomplete drinking water 
assessment?
    Answer. The national scale drinking water assessment for 
chlorpyrifos was completed in 2014 and showed that many uses at maximum 
label rates and rates lower than maximum would result in concentrations 
exceeding the drinking water level of concern. Because of these 
results, further analysis was conducted to look at the spatial 
distribution of estimated drinking water concentrations at a regional 
scale. This exercise is a higher level refinement and not generally 
completed or required for most pesticides. As such, the EPA finished a 
regional analysis for two regions of the country, the Pacific Northwest 
and South Atlantic-Gulf, to demonstrate the feasibility of this 
methodology and to solicit public comment on the approach. The EPA is 
currently finalizing the regional assessment for the remaining regions 
of the United States.

    Question 41a. While the Agency reached this high level of 
refinement for the food dietary assessment since the passage of FQPA in 
1996, why has the Agency not reached a comparable level of refinement 
in their assessment methodologies for drinking water over that same 
time period of 20 years?
    Answer. The level of sophistication of the EPA's drinking water 
assessments has greatly improved over the past 20 years. Drinking water 
assessments, including the assessment conducted for chlorpyrifos, now 
include the ability to account for the impact of different soils, 
agronomic practices, meteorological data, application methods and 
timing, buffers, volatility, and application technology, just to name a 
few areas where our modeling capabilities have improved. Current 
drinking water assessments also better account for the percentage of 
community drinking water intake watersheds that could be treated by the 
pesticide and drinking water treatment effects. Monitoring data, when 
available, also plays a larger role in our ability to predict and 
characterize pesticide concentrations under actual use conditions.

    Question 41b. Since the Agency has had that much time to refine 
their drinking water assessment methodology, why then is there a rush 
to decision on chlorpyrifos?
    Answer. The chlorpyrifos drinking water assessment is highly 
refined and incorporates all currently available data and methodologies 
for predicting exposure through drinking water. The timeline for 
decision making was set by the U.S. Court of Appeals for the Ninth 
Circuit.

    Question 41c. Why does the Agency refuse to use reliable data from 
tens of thousands of water monitoring samples for chlorpyrifos and 
other pesticides, and instead insist on using modeling procedures that 
are not validated by data, and produce conflicting conclusions?
    Answer. The EPA uses mathematical models as well as monitoring data 
to generate exposure estimates for drinking water and aquatic exposure 
assessments. Modeling and monitoring data are both important tools that 
provide different types of information that can be used for assessing 
pesticide concentrations in water. Models calculate estimated drinking 
water concentrations using laboratory data that describe how fast a 
pesticide breaks down to other chemicals and how it moves in the 
environment. In addition, modeling provides an efficient tool for 
exploring the impact of different environmental factors such as soil 
type and meteorological conditions on estimated pesticide 
concentrations in water. Although computer modeling provides an 
indirect estimate of pesticide concentrations, these concentrations can 
be estimated continuously over long periods of time, and for places 
that are of most interest for a particular pesticide. Modeling is a 
useful tool for characterizing vulnerable sites, and can be used to 
estimate peak concentrations from infrequent, large storms (https://
www.epa.gov/pesticide-science-and-assessing-pesticide-risks/about-
water-exposure-models-used-pesticide) [See Attachment 6].
    Monitoring data provide snapshots of pesticide concentrations in 
time at specific locations. When the monitoring sites reflect areas 
that have a likelihood of pesticide occurrence in water (based on 
pesticide use as well as local runoff or leaching vulnerability), when 
sampling occurs during the time frame in which pesticides are expected 
to be used, and when the sampling is frequent enough to estimate 
exposures for the endpoints of concern, it is more likely that the EPA 
will be able to incorporate that data quantitatively. Monitoring data 
will typically underestimate upper bound or peak concentrations due to 
insufficient sampling frequency. While this is more of a concern for 
surface water monitoring, it can still be a consideration for 
groundwater monitoring. Therefore, monitoring data often are expected 
to provide a lower bound estimate of exposure for purposes of risk 
assessment. Statistical methods are being developed to address the 
uncertainty in estimating upper bound pesticide concentrations from 
monitoring data.
    Often, sampling frequency and location are limiting factors in 
comparing monitoring results to modeling or in using monitoring data 
quantitatively. However, monitoring data can also be valuable in adding 
context to the exposure assessments. For instance, detections of a 
given pesticide can provide a measure of a lower bound of exposure. 
While the data may not be robust enough to ensure a high-end exposure 
has been observed, the detections do indicate that transport has 
occurred in the study. At a minimum, qualitative data can provide a 
balance against modeled estimates and can be useful for 
characterization of risk conclusions.
    The EPA uses all reliable laboratory and field/monitoring data to 
assess pesticide exposure in drinking water. In the case of 
chlorpyrifos, water monitoring data from the U.S. Geological Survey 
(USGS) National Water-Quality Assessment Program (NAWQA), USEPA/USGS 
Pilot Reservoir Monitoring Program, USDA Pesticide Data Program (PDP), 
and California Department of Pesticide Regulation (CDPR) were evaluated 
in the 2011 preliminary drinking water assessment with reference to an 
acute exposure to chlorpyrifos and its degradation product 
chlorpyrifos-oxon. For the 2014 assessment, additional water monitoring 
data from Washington State Department of Ecology and Agriculture (WSDE/
WSDA) Cooperative Surface Water Monitoring Program, Dow AgroSciences 
(Orestimba Creek), and Oregon Department of Environmental Quality were 
evaluated and presented as part of the drinking water assessment 
update.
    Additionally, model simulations were completed to represent two 
different water monitoring datasets--WSDE/WSDA and Orestimba Creek. For 
both of these water monitoring programs, enough information was 
available, including chlorpyrifos use information, as well as the 
percent cropped area, to parameterize the model. In these simulations, 
the modeled concentrations were within an order of magnitude of the 
measured concentrations. This suggests that the modeling results are 
not overly conservative and provide reliable estimates in the absence 
of all the necessary information to put monitoring results into proper 
context.

    Question 42. The Agency has publicly advocated for harmonization in 
tolerances among trading partner countries.
    Why has EPA taken the step of this Proposed Rule with no agreement 
among other countries and seemingly no evaluation of or concern about 
potential impact on trade?
    Answer. In making its tolerance decisions, the EPA seeks to 
harmonize U.S. tolerances with international standards whenever 
possible, consistent with U.S. food safety standards and agricultural 
practices. However, the EPA is unable to determine at this time that 
aggregate exposures to chlorpyrifos are safe. The timing of this 
proposal is the result of a U.S. Court of Appeals for the 9th Circuit 
Court order to respond to that petition by October 31, 2015. This 
proposal also implements the agency findings made during the 
registration review process required by section 3(g) of FIFRA (7 U.S.C. 
136(a)(g)) which the EPA is conducting in parallel with its petition 
response. That process requires the EPA to re-evaluate existing 
pesticides every 15 years to determine whether such pesticides meet the 
FIFRA registration standard set forth in FIFRA section 3(c)(5), 7 
U.S.C. 136a(c)(5). In part, that standard requires the EPA to ensure 
that dietary risks from the pesticide meet the FFDCA section 408 safety 
standard. Section 408 directs that the EPA may establish or leave in 
effect a tolerance for pesticide only if it finds that the tolerance is 
safe, and the EPA must revoke or modify tolerances determined to be 
unsafe (FFDCA 408(b)(2)(A)(i)). Section 408(b)(2)(A)(ii) defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' In its Revised Human Health Risk 
Assessment, the EPA determined some exposures to chlorpyrifos may be 
unsafe. The Revised Human Health Risk Assessment * is available at 
www.regulations.gov in the chlorpyrifos docket (EPA-HQ-OPP-2008-0850-
0195).
---------------------------------------------------------------------------
    * Editor's note: the document referred to is retained in Committee 
file.

    Question 42a. What is your obligation under the World Trade 
Organization Sanitary Phytosanitary Agreement (WTO SPS) in this 
respect, and how has it been fulfilled?
    Answer. The EPA ensures that its tolerance decisions are in keeping 
with the World Trade Organization's Sanitary and Phytosanitary Measures 
Agreement. Consistent with that agreement, the effective date the EPA 
is proposing for the revocation of chlorpyrifos tolerances in the 
proposed rule ensures that the tolerances will remain in effect for a 
period sufficient to allow a reasonable interval for producers in the 
exporting countries to adapt to the requirements of these modified 
tolerances. The EPA plans to issue a notice by the fall of 2016 with 
updates to part of its risk assessment, including a refined drinking 
water assessment. With the issuance of the notice, the EPA will notify 
the WTO and ask for further comment on the proposed rule and underlying 
science. The EPA will consider WTO's comments prior to issuing a final 
decision.

    Question 43. By establishing a policy of ``no net loss'' for 
natural resources, doesn't the Presidential Memorandum: Mitigating 
Impacts on Natural Resources from Development and Encouraging Related 
Private Investment change how NEPA operates by requiring agencies to 
avoid, minimize, and fully mitigate impacts to natural resources? Will 
EPA follow the policies of the memorandum in the NEPA process? Is it 
correct that NEPA does not ``mandate protection of the environment,'' 
but requires impacts to be identified? By establishing a policy of ``no 
net loss'' for natural resources, doesn't the Presidential Memorandum 
change the function of NEPA by requiring agencies to authorize only 
actions that avoid, minimize, and fully mitigate impacts to natural 
resources?
    Answer. The EPA and other Federal agencies have extensive 
experience consistently implementing the provisions of the National 
Environmental Policy Act (NEPA) while working to achieve a ``no net 
loss'' of natural resources goal. The administration established a 
nationwide ``no net loss'' of wetlands goal in 1989, for example, that 
has been very successful in reducing annual conversion and destruction 
of wetlands without changing the operation of NEPA. The EPA is 
confident, based on our experience, that the new Presidential 
Mitigation Memorandum does not alter the way NEPA has traditionally 
been implemented or change its basic function.
Questions Submitted by Hon. Collin C. Peterson, a Representative in 
        Congress from Minnesota
    Question 1. The EPA has been reviewing biogenetic carbon-dioxide 
emissions for a few years now and it's seemed to come to a head with 
the Clean Power Plan. My understanding is that under the current 
framework for biogenetic carbon-dioxide, agricultural residue is 
treated the same as fossil fuels in Clean Power Plan compliance, unless 
it's sustainably grown. Using agricultural residues for energy 
production, bioproducts, and biofuels already happens. We want our 
farmers to be a part of the solution and I'm a bit perplexed how grown 
plants are treated the same as fossil fuels. Can you explain the 
current framework the EPA is using to assess biogenetic carbon-dioxide 
emissions? And are you consulting with USDA in regard to determining 
``sustainably grown'' so our farmers can participate?
    Answer. On February 9, 2016, the Supreme Court granted a motion to 
stay the Clean Power Plan (CPP). As a result of that action, states are 
not currently required to submit a state plan or a request for 
extension by September 6, 2016.
    In the final CPP, states have the flexibility to choose whether or 
not to allow affected sources to use biomass as a compliance option to 
meet their emission standards. The CPP gives states the flexibility to 
describe the types of biomass that are being proposed for use under 
their state plans, how those proposed feedstocks or feedstock 
categories should be considered as ``qualified biomass'' (i.e., a 
biomass feedstock that is demonstrated as a method to control increases 
of CO2 levels in the atmosphere), and explain the proposed 
valuation of biogenic CO2 emissions.
    The EPA generally acknowledges the CO2 and climate 
policy benefits of waste-derived biogenic feedstocks and certain 
forest- and agriculture-derived industrial byproduct feedstocks. The 
final rule also provides that states may use agricultural and forest 
biomass feedstocks if they adequately demonstrate that the use of such 
feedstocks appropriately controls increases of CO2 levels in 
the atmosphere.
    As part of the EPA's effort to advance the technical understanding 
of the role of biomass in addressing greenhouse gas emissions, in 
November 2014, the EPA released the second draft of its scientific 
report, Framework for Assessing Biogenic Carbon Dioxide for Stationary 
Sources. The revised report takes into account Science Advisory Board 
peer review recommendations on the 2011 Draft Framework, as well as the 
latest information from the scientific community and other 
stakeholders. The EPA developed the revised Framework as a policy-
neutral framework for assessing biogenic CO2 emissions from 
stationary sources--it was not developed as technical guidance in 
conjunction with any specific policy or program. The EPA's continued 
refinements of the Framework will parallel the EPA's consideration of 
biomass in the context of its policies and programs.
    As in the case of other scientific and policy processes, for 
biomass topics we consult with relevant experts, such as our colleagues 
at USDA, states, stakeholders, and academic and research scientists to 
provide information and examples of existing and potential programs 
recognized as carbon-beneficial and therefore possible approaches to 
achieving the goals articulated in the President's Climate Action Plan.

    Question 2. I was contacted by an ag procession plant in my 
district and discovered that not only do plants have to have an OSHA 
worker protection plan, but apparently EPA also requires a worker 
protection plan. And now with the Food Security Modernization Act 
(FSMA), there will be a third requirement that will also involve worker 
training. Is there any coordination between OSHA and DPA in regard to 
what these worker protection plans encompass? Is there flexibility for 
plants to use one plan to cover both requirements? Or do they literally 
have to have two separate plans?
    Answer. First, to the extent that these concerns with the 
Agricultural Worker Protection Standard (WPS) rule were raised in 
regard to an agricultural processing plant, please note that post-
harvest uses of pesticides are excepted from the requirements of the 
WPS (170.303(b)(5)), so the WPS does not apply to the use of pesticides 
in agricultural processing plants and such processing plants are not 
otherwise affected by the WPS.
    Second, the WPS also does not require a written worker protection 
plan. Employers only need to comply with the provisions of the rule, 
but are not required to develop a written plan describing how they will 
meet the requirements of the rule. The EPA has also coordinated with 
the Occupational Safety and Health Administration to ensure there is 
not overlap of our regulations.
Questions Submitted by Hon. Christopher P. Gibson, a Representative in 
        Congress from New York
    Question 1. The Hudson River Natural Resource Trustees--USF&W and 
NOAA--have publicly called for additional environmental dredging of the 
Hudson River Superfund site by GE and asked EPA to delay GE's 
decommissioning of its cleanup operations before certifying the cleanup 
as complete. Would EPA be willing to meet with these environmental 
leaders to discuss the Agency's reasoning behind its Hudson River 
dredging decision?
    Answer. The EPA has discussed the decommissioning of General 
Electric's sediment processing facility and other operations with the 
Federal Natural Resource Trustees for the Hudson River. In particular, 
the U.S. Fish and Wildlife Service (FWS) and the National Oceanic and 
Atmospheric Administration (NOAA) actively participate in meetings of 
the Hudson River Community Advisory Group (CAG), and both NOAA and FWS 
have taken part in CAG meetings at which the EPA explained its reasons 
for approving GE's facility decommissioning.

    Question 2. According to my constituents, EPA responded in December 
2015 to the Natural Resource Trustees' that the cleanup is inadequate 
and will not meet EPA's own goals. In this response to Hudson River 
environmental leaders, EPA Assistant Administrator Mathy Stanislaus and 
Regional Administrator Judith Enck agreed to an expedited 5 year review 
to determine whether the Hudson River Superfund cleanup has met its 
goals. The following month, R.A. Enck published an Op-Ed in the Albany 
Times Union stating the cleanup has achieved its goals.
    What will EPA do to ensure the 5 year review is conducted without 
bias, expeditiously in conformance with EPA guidance, and in a manner 
that ensures the input of the Trustees as equal partners and of the key 
environmental and other stakeholders?
    Answer. The second 5 year review for the site is underway and is 
being conducted in accordance with the EPA guidance. The EPA is working 
closely with all stakeholders to ensure a thorough and unbiased 5 year 
review. The stakeholders, including the Federal trustees, New York 
State Department of Environmental Conservation and Department of 
Health, and representatives of the Community Advisory Group (including 
non-governmental organizations) were invited by the EPA to participate 
on the Five Year Review team. Five Year Review team meetings are being 
held monthly through the fall.

    Question 3. Is EPA considering any additional options that have not 
already been pursued to promote further clean-up and safeguarding of 
the Hudson River?
    Answer. The second 5 year review is underway and the EPA is working 
closely with all stakeholders to ensure a thorough 5 year review. The 
stakeholders, including the Federal trustees, the New York State 
Department of Environmental Conservation and Department of Health, and 
representatives of the Community Advisory Group (including 
nongovernmental organizations) were invited by the EPA to participate 
on the Five Year Review Team. The EPA supports the trustees' continuing 
efforts to safeguard the Hudson River and will continue to cooperate 
and communicate with Federal and state natural resource trustees on the 
Hudson River remediation.
Questions Submitted by Hon. Vicky Hartzler, a Representative in 
        Congress from Missouri
          The following questions relate to the Agency's Worker 
        Protection Standards (WPS) rule [40 CFR 170 et seq.] which was 
        signed by the Administrator on September 28, 2015 and published 
        in the Federal Register on November 2, 2015.
Statutory Requirements
          Section 25(a)(2)(B) of the Federal Insecticide Fungicide and 
        Rodenticide Act (7 U.S.C. 136w(a)(2)(B)) states: ``At least 30 
        days prior to signing any regulation in final form for 
        publication in the Federal Register, the Administrator shall 
        provide the Secretary of Agriculture with a copy of such 
        regulation.'' Section 25(a)(3) (7 U.S.C. 136w(a)(3)) of FIFRA 
        also states: ``At such time as the Administrator is required 
        under paragraph (2) of this subsection to provide the Secretary 
        of Agriculture with a copy of proposed regulations and a copy 
        of the final form of regulations, the Administrator shall also 
        furnish a copy of such regulations to the Committee on 
        Agriculture of the House of Representatives and the Committee 
        on Agriculture, Nutrition and Forestry of the Senate.''

    Question 1. Please state for the record the date on which EPA 
provided to the Secretary of Agriculture the final copy of the WPS rule 
that was signed on September 28, 2015.
    Answer. The EPA sent the draft final Worker Protection Standard 
rule to the Secretary of Agriculture on May 13, 2015. This draft final 
rule did not include provisions for authorized or designated 
representatives. After further deliberations, the EPA decided to 
restore these provisions, with certain limitations and modifications. 
The EPA provided the revised draft final rule to USDA on June 22, 2015. 
As required under section 25(a)(2)(D) of FIFRA, the EPA announced the 
notification to the Secretary of Agriculture for this review in the 
Federal Register (80 FR 28838, May 20, 2015).

    Question 2. Please state for the record the date on which EPA 
provided to the House Committee on Agriculture the final copy of the 
WPS rule that was signed on September 28, 2015.
    Answer. As required under section 25(a)(3) of FIFRA, the EPA sent 
the pre-promulgation draft of the final rule to the U.S. House of 
Representative's Committee on Agriculture and to the U.S. Senate's 
Committee on Agriculture, Nutrition, and Forestry on May 14, 2015. In 
addition, as required under the Congressional Review Act (5 U.S.C. 801 
et seq.), the EPA submitted a report containing the final copy of the 
rule that was signed on September 28, 2015, and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States on October 9, 2015.

          The WPS rule (40 CFR 170.311) grants a designated 
        representative the right to certain pesticide information used 
        on a farm upon presentation of a written, signed authorization 
        by a worker. Please answer the following questions related to 
        this provision.

    Question 3. With a letter to the House Agriculture Committee from 
Assistant Administrator Jim Jones dated May 12, 2015 Mr. Jones enclosed 
a ``draft final rule revising and updating the agricultural Worker 
Protection Standard.'' Please cite the section of the rule submitted to 
the Committee on May 12, 2015 that contains language granting either to 
``authorized representatives'' or ``designated representatives'' access 
to farm-specific pesticide information.
    Answer. The May 12, 2015 draft final rule did not include 
provisions for authorized or designated representatives. The proposed 
rule, published March 19, 2014, included provisions relating to 
authorized representatives in the draft sections 170.5 and 170.11(b)(2) 
and on pages 15479-15480 of the preamble a discussion of the 
provisions, but as of May 12, 2015, the EPA was not intending to 
finalize those provisions. After further deliberations, the EPA decided 
to restore these provisions, with certain limitations and 
modifications. The EPA provided the revised draft final rule to USDA on 
June 22, 2015. Pursuant to the Congressional Review Act (5 U.S.C. 801 
et seq.), the final version of the rule was submitted to Congress on 
October 9, 2015.

    Question 4. Please provide to the Committee copies of any comments, 
including e-mails, memos or other documents, submitted to EPA from the 
U.S. Department of Agriculture or other executive department offices, 
including the White House, that relate to the original proposed 
provision relating to ``authorized representative'' and to the 
provision in the final rule relating to ``designated representative.''
    Answer. USDA's comments, and the EPA's responses to the proposed 
rule and the final rule, are included in the public docket as part of 
the Executive Order documentation, and those comments and responses 
related to the authorized representative and the designated 
representative are available from under docket ID EPA-HQ-OPP-2011-
0184.\4\ This provision was not an area of significant deliberation 
during the interagency review process for this rulemaking.
---------------------------------------------------------------------------
    \4\ https://www.regulations.gov/document?D=EPA-HQ-OPP-2011-0184-
2520 [See Attachment 8].

    Question 5. In the final WPS rule (Federal Register, page 67513, 
November 2, 2015), EPA states that it ``has been convinced by comments 
in support to retain the option for a designated representative.''
    Please provide the Committee copies of the comments to which the 
Agency refers in the Federal Register notice.
    Answer. The EPA received a significant number of comments in 
support of and in opposition to retaining the proposal for the 
designated or authorized representative. Few of the comments presented 
new information or information substantially different from that known 
to the EPA at the time the proposed rule was published, and as a 
result, the comments--both pro and con--collectively convinced EPA that 
it was correct in its initial opinion that a designated representative 
provision is reasonable and appropriate. However, some commenters 
provided recommendations that appear to be appropriate remedies for 
legitimate concerns about the proposed requirement. The EPA 
reconsidered the proposed option and alternatives, and concluded that 
retaining the option for a worker to designate a representative was 
necessary for their ability to access pesticide hazard information, but 
specified in more detail the requirements for designating a 
representative and for a designated representative's request 
information. See 40 CFR Part 170.311(b)(9).
    Although the EPA considers the collective comments--pro and con--as 
confirming the agency's decision to include a designated representative 
provision in the WPS, the comments below in support of the designated 
representative option for enhancing access to pesticide hazard 
communications information provide additional insight.

   Migrant Clinicians Network.\5\
---------------------------------------------------------------------------
    \5\ https://www.regulations.gov/document?D=EPA-HQ-OPP-2011-0184-
2291 [See Attachment 9].

   Farmworker Advocacy Network.\6\
---------------------------------------------------------------------------
    \6\ https://www.regulations.gov/document?D=EPA-HQ-OPP-2011-0184-
2250 [See Attachment 10].

   American Public Health Association.\7\
---------------------------------------------------------------------------
    \7\ https://www.regulations.gov/document?D=EPA-HQ-OPP-2011-0184-
1846 [See Attachment 11].

   Florida Legal Services.\8\
---------------------------------------------------------------------------
    \8\ https://www.regulations.gov/document?D=EPA-HQ-OPP-2011-0184-
2166 [See Attachment 12].

   Telamon Corporation.\9\
---------------------------------------------------------------------------
    \9\ https://www.regulations.gov/document?D=EPA-HQ-OPP-2011-0184-
0179 [See Attachment 13].

    Question 5a. Were any of the comments received by the Agency after 
the close of the comment period?
    Answer. Some comments were received after the comment period 
closed. All were included in the docket, regardless of the date they 
were submitted; and were considered in developing the final rule. These 
comments received after the close of the comment period were not 
significantly different and did not raise issues or present new 
information than those submitted by the close of the comment period.

    Question 5b. Were any of these comments the result of ex parte 
communications? Please supply copies of those comments?
    Answer. All comments related to the Worker Protection Standard 
rulemaking received by the EPA during the period between proposal and 
publication of the final rule were added to the docket, where they 
became a matter of public record available for review (except for those 
portions of comments submitted under business confidentiality claims or 
containing personal privacy information). Written comments appear in 
the docket as submitted.

    Question 6. The Federal Register notice of November 2, 2015 says 
that ``EPA is unaware of issues related to worker representatives in 
those states.'' [referring to Texas and California].
    Please provide the Committee with any analysis or documents used by 
EPA in analyzing the Texas and California provisions.
    Answer. The only documents the EPA reviewed related to the Texas 
and California provisions were the regulations for Texas and California 
related to agricultural worker representatives.
    The Texas Agricultural Hazard Communication Act at (http://
www.statutes.legis.state.tx.us/Docs/AG/htm/AG.125.htm.htm) [See 
Attachment 14] establishes procedures for the designated 
representative's access to information about hazardous chemicals to 
improve the health and safety of agricultural workers. In addition, 
Texas provided comments on the proposed rule related to the provision, 
noting that the requirement to provide the information should coincide 
with the record retention schedule and should be in writing.
    The California Code of Regulations, Sections 6723 and 6761 at 
(http://www.cdpr.ca.gov/docs/legbills/calcode/subchpte.htm#a0303) [See 
Attachment 15], establish requirements for employers to provide, upon 
request from an employee representative, access to any records or 
documents required to be maintained under the regulation.

    Question 6a. Please provide the Committee any documents or analysis 
prepared or utilized by EPA that demonstrates that the Texas and 
California provisions have directly resulted in greater worker safety.
    Answer. The EPA is not aware of any documents or analyses that 
assess improvements in worker safety as a direct result of these 
provisions.

    Question 7. Please provide the Committee with documents or 
memoranda it used to analyze the OSHA regulation and its applicability 
in requiring similar provisions in an agricultural setting.
    Answer. The EPA considered the requirements of the U.S. 
Occupational Safety and Health Administration's regulation at 29 U.S.C. 
section 1910.1020 (https://www.osha.gov/pls/oshaweb/
owadisp.show_document?p_table=STANDARDS&p_id=
10027) [See Attachment 16], and believes similar requirements should 
apply to agriculture. As cited in the preamble to the proposed Worker 
Protection Standard (March 19, 2014), in adopting the Hazard 
Communication Standard (HCS), OSHA stated there was evidence to 
indicate potential for chemical exposure in every type of industry, and 
that lack of knowledge about those hazardous chemicals puts employees 
at significant risk of experiencing material impairment of health (52 
FR 31852; August 24, 1987;) (59 FR 6126; February 9, 1994). The OSHA 
rule applies to general industries, maritime, and construction 
employers who are responsible for records of employee exposure to toxic 
substances or harmful physical agents, among other requirements, but 
expressly does not apply to agricultural employers per 29 CFR Part 
1928.21(b). The OSHA rule requires that the employer provide to the 
designated representative (or requesting employee) access to the 
employee's exposure record upon their request, in a reasonable time, 
place, and manner.
    The Worker Protection Standard requires agricultural employers to 
maintain pesticide application records and Safety Data Sheets when 
workers are on the establishment. These records provide the exposure 
and hazard information, parallel to those required under OSHA's rules 
for other industries. Farmworkers, in terms of demographics, are 
similar to construction workers, in that their jobs may be short term, 
of low economic status; and they may be low literacy and non-English 
speaking. The EPA believes that agricultural production can comply with 
these requirements with little disruption. The EPA recognizes that a 
significant number of workers face disadvantages that can reasonably 
make them reluctant to ask their employers for information related to 
their pesticide exposure, and finds that access to the information 
through a designated representative, similar to the requirement in 
OSHA's HCS, is feasible and appropriate to protect worker safety.

    Question 8. Does the authorization from the worker to the 
designated representative need to be notarized?
    Answer. The authorization does not need to be notarized.

    Question 9. Once a farmer is presented with a written, signed 
authorization, does the farmer have a legal obligation to provide the 
information?
    Answer. Under the Worker Protection Standard, the designated 
representative authorization must also be accompanied by a request 
letter containing certain information. If a valid designated 
representative authorization is accompanied by a valid request for 
information required by the WPS to be provided, then the farmer does 
have a legal obligation to provide only the information required by the 
rule.

    Question 10. Once the designated representative has the 
information, are there restrictions on what the designated 
representative may do with the information? (If so, please cite the 
section of the regulation restricting use of the information.)
    Answer. The Worker Protection Standard does not place restrictions 
on what the farmworker or designated representative may do with the 
information.

    Question 11. Once the designated representative has obtained the 
information from the farmer, does the designated representative have 
any obligation to transmit or share that information with the worker 
who authorized access to the information? (If so, please cite the 
section of the regulation.)
    Answer. The Worker Protection Standard does not impose on the 
farmworker or designated representative any obligation to transmit or 
share that information with the worker who authorized access to the 
information.

    Question 12. The section of the WPS immediately preceding that 
related to designated representatives ( 170.309(8)) states that ``any 
treating medical personnel or any person acting under the supervision 
of treating medical personnel'' may request pertinent information and 
may do so either orally or in writing. Thus, it appears that the access 
granted to designated representatives serves a purpose other than 
providing for the medical treatment of a worker who has been exposed to 
a pesticide.
    What purposes, other than those related to the health or exposure 
of a worker to a pesticide, does  170.309(9) serve?
    Answer. Workers and handlers may be reluctant to request the 
information for themselves due to their inability to communicate 
effectively with, or fear of, their employer, or because they may not 
be able to understand the information without help. The required 
information can be of value to workers before medical care is sought: 
First, having information available in non-emergency situations could 
help workers be aware of symptoms before they occur, help them avoid 
exposure, and possibly enhance the reporting of illnesses. Second, 
having access to the required information in advance of any medical 
need means emergency medical personnel would not have to lose critical 
time tracking down information instead of treating the ill or injured 
person. Third, having information available in non-emergency situations 
could help workers be aware of symptoms of chronic illnesses, 
potentially enabling them to seek treatment earlier in the course of 
the illness.
    Because of the potential burden to agricultural employers, the rule 
does not require that the required pesticide application information 
and Safety Data Sheets that provide the hazard information must be 
provided in any language other than English, although many farmworkers 
and pesticide handlers are not literate in English or even their native 
languages. Therefore there are potentially many circumstances these 
individuals could need the assistance of a designated representative to 
have ``meaningful access'' to the information such as having it 
translated in order to be able to make use of the information. 
Additionally, many farmworkers could be limited in their ability to get 
transportation back to an employer's establishment after employment but 
would need the assistance of a designated representative to access the 
information they desire.

    Question 12a. Please cite EPA's statutory authority to require a 
farmer to grant access to third parties for proprietary pesticide 
information when that access is not related to worker safety?
    Answer. As discussed in the response to the previous question, the 
ability for a worker or handler to have meaningful access to the 
required pesticide application and hazard information is very much 
related to worker safety. In the 1992 rule, and continued in this 
revision, access to exposure information and first aid and other 
medical information is required for medical personnel in cases of 
injury or illness. For the reasons cited above the worker may not be 
able to access or make use of the information provided and would need a 
designated representative to get meaningful access to that information 
in order to understand the hazards of the chemicals he/she is working 
around, be better able to protect themselves, recognize potential signs 
of exposure or illness, and know how to respond appropriately if 
needed. The EPA's statutory authority to establish requirements to 
protect worker safety is outlined in the rule and derives from FIFRA's 
mandate to prevent unreasonable adverse effects on ``the environment'', 
which FIFRA section 2(j) defines as including humans. Agricultural 
workers are clearly part of ``the environment'' for purposes of FIFRA, 
as discussed in U.S. Senate. S. Rep. No. 92-883 (Part II), 92nd 
Congress, 2nd Session at 43-46 (1972). U.S. Code Congressional and 
Administrative News 1972, p. 4063.

    Question 13.  170.305 of the regulation states that a ``designated 
representative means any persons designated in writing by a worker or 
handler to exercise a right of access on behalf of the worker or 
handler to request and obtain a copy of the pesticide application and 
hazard information required by  170.309(h) in accordance with  
170.311(b) of this part.''
    Are there any provisions in the WPS restricting who may be a 
designated representative? (If so, please cite the section of the 
regulation.)
    Answer. There are no restrictions on who may be a designated 
representative.

    Question 13a. Would the WPS permit organizations like anti-
pesticide activist groups to serve as designated representatives?
    Answer. Any person or organization can serve as the designated 
representative if they have been properly designated in writing and the 
request conforms to section 170.311(b)(9).

    Question 14. If a designated representative had information related 
to pesticide use on a farm and wished to publish that information 
broadly, are there provisions in the WPS to prevent that from 
happening? (If so, please cite the section of the regulation)
    Answer. The Worker Protection Standard does not include provisions 
that would prevent a farmworker or designated representative from 
publishing the information required under section 170.309(h).

    Question 15. If a designated representative had gained information 
related to pesticide use on a farm through a written declaration 
authorized under  170.311(b) and wanted to use that information 
publicly to exert pressure on a farmer to stop the farmer from using 
that pesticide, are there provisions in the WPS to prevent that from 
happening? (If so, please cite the provision)
    Answer. The Worker Protection Standard does not include provisions 
that would prevent a farmworker or designated representative from using 
the information required under section 170.309(h) publicly.

    Question 16. Many hired workers in agriculture--by most estimates 
more than 50% of the hired labor force--work in agriculture by 
presenting documents that contain false names, social security numbers, 
green cards or other information. An employer, such as a farmer, is 
legally required to accept such documents if they appear to be genuine. 
Because of this fact, it may be possible for an individual to present 
himself or herself to a farmer claiming to be a designated 
representative for a worker with a name that does not appear on the 
farmer's records. If the designated representative states that the 
individual worker did work on the farm but under a different name, what 
is the farmer's legal obligation?
    Is the farmer's legally obliged to release the pesticide 
information? (If not, please cite the section of the regulation 
releasing the farmer from legal responsibility)
    Answer. Where a person claiming to be a designated representative 
presents the name of a worker or handler that does not appear on the 
employer's records, the employer could refuse to provide the requested 
information unless other evidence, documentation or information known 
to the employer reasonably supports a conclusion that the worker or 
handler being represented by the designated representative was actually 
employed on the establishment.

    Question 16b. If the farmer does not release the information, is 
the farmer protected under the WPS? (Please cite the specific 
provision).
    Answer. Yes. If a designated representative's request for 
information does not meet the requirements of section 170.311(b)(9), an 
employer's refusal to provide the requested information would not be a 
violation of FIFRA.

    Question 16c. If a designated representative has been found to be 
abusing this provision of the WPS, what sanctions would that individual 
face? (Please cite the specific provisions)
    Answer. The Worker Protection Standard does not include provisions 
that would provide sanctions against a designated representative.

    Question 17. Given the concerns that have been raised by the 
agriculture community over the designated representative provision, 
would EPA be willing to suspend implementation of the provision and 
revise it after consultation with representatives of the agricultural 
community and re-proposing it in the Federal Register?
    Answer. The EPA included a representative access provision in the 
proposed rule, specifically requested comment on potential problems it 
could cause (79 FR 15444, 15479), and received many pertinent comments 
from a broad range of commenters, few of which identified likely 
problems that were significantly different from those contemplated by 
the EPA at the time of proposal. The EPA does not expect that an 
additional comment period would produce significantly different 
information, but in any case, any person who has such information may 
submit it at any time for the EPA to review.
    If the agency is presented with evidence that this provision of the 
rule is creating undue burden for the agricultural community, or the 
provision is being abused by certain designated representatives, the 
agency will consider whether the evidence warrants regulatory action in 
response. However, the EPA does not believe there are sufficient 
grounds for changing the rule at this time.
Questions Submitted by Hon. Jeff Denham, a Representative in Congress 
        from California
    Question 1. The National Association of Clean Air Agencies 
testified to EPA that the new 2015 ozone standard ``will have a 
profound impact on the work of the state and local air pollution 
control agencies.'' This is troubling, especially considering many of 
these same agencies are still working on the 2008 ozone standard, which 
has yet to be fully implemented.
    Given its geographical layout and persistent droughts, California's 
Central Valley has had to expend exceptionally more resources to keep 
up with every reaching air standards.
    What type of assurance is the EPA giving our states and local 
governments, municipalities, and businesses that the EPA is not setting 
them up to fail by constantly moving the clean air goalpost?
    Answer. The EPA and state co-regulators share a long history of 
managing ozone air quality under the Clean Air Act (CAA), underpinned 
by a wealth of previously issued EPA rules and guidance. The overall 
framework and policy approach reflected in the implementing regulations 
for the 2008 ozone standards provide an effective and appropriate 
template for the general approach states would follow in planning for 
attainment of the revised 2015 ozone NAAQS. In particular for 
California areas where the state and districts are still actively 
working toward attaining the 2008 ozone NAAQS, the EPA is committed to 
continue helping these air agencies identify and take advantage of 
potential planning and emissions control efficiencies that may occur 
within the horizon for attaining the 2015 standards. Following past 
precedent, the EPA intends to propose revoking the 2008 standards and 
provide transition rules intended to help avoid any potential 
inefficiencies as states begin implementing the Clean Air Act's 
requirements for the 2015 standards.

    Question 2. Taking into account EPA's accidental release of farm 
information to environmental activist groups in 2013, farmers and 
ranchers in my district are understandably concerned about the lack of 
data security measures preventing the EPA from collecting superfluous 
farm information.
    In light of the 2013 incident--as well as other highly damaging 
breaches into OPM and DOD--what improvements has the EPA made, or is 
the EPA making, to ensure it only collects the information it needs, 
and that such information is secure?
    Answer. The EPA is continually working to improve its processes for 
collecting and managing data related to environmental protection 
programs. For example, the EPA recently established through rulemaking 
the minimum set of NPDES program data based on the EPA's current 
reporting requirements (see Appendix A to 40 CFR Part 127) [See 
Attachment 7]. During the development of this rulemaking, the EPA 
carefully considered input from authorized state programs, provided in 
comments and meetings, to match the minimum set of NPDES program data 
to the existing regulations and practice, including how these data are 
currently used by the EPA and authorized state programs. The EPA and 
states streamlined the NPDES electronic reporting requirements down to 
the minimum number of data elements needed to oversee management of the 
NPDES programs in the most efficient manner possible
    In addition, due to comments received during the NPDES Electronic 
Reporting Rule [see: Comment Response Document for the NPDES Electronic 
Reporting Rule (Final Rule),* EPA-HQ-OECA-2009-0274-0575, available at: 
http://www.regulations.gov], the EPA is masking facility specific 
information for unpermitted CAFOs that are not in violation of the CWA, 
responding to particular privacy concerns raised regarding operators 
living in close proximity to these facilities.
---------------------------------------------------------------------------
    * Editor's note: the document referred to is retained in Committee 
file.
---------------------------------------------------------------------------
    More broadly, the EPA is taking steps to improve the agency's 
information security posture and meet the Administration's 
cybersecurity cross-agency priority goals. The EPA improved the use of 
strong authentication for logging onto the EPA network, improved anti-
phishing protections, and coordinated with the Department of Homeland 
Security to improve asset and vulnerability management and malware 
defenses.

    Question 3. Your Agency's honeybee acute toxicity proposal could 
restrict the use of over 3,000 crop protection products when a grower 
has contracted for pollination services. These products are primarily 
derived from 76 Active Ingredients. How did EPA decide on these Active 
Ingredients? Were risk assessments and benefits analysis conducted, as 
is required by law, before this proposal was published?
    Answer. EPA's Proposal to Mitigate Exposure to Bees from Acutely 
Toxic Pesticide Products is aimed at providing greater protection to 
bees where acute risk is presumed to be the highest, namely when 
certain exposure (i.e., contract pollination scenarios) and presence of 
an acutely toxic pesticide coincide. For this proposed risk mitigation 
strategy, the agency focused only on a subset of compounds identified 
as highly toxic to bees, which are likely to have the greatest adverse 
effect on bees. The 76 active ingredients are those that have been 
determined via testing to have an acute contact toxicity value less 
than 11 micrograms per bee, based on data required to be submitted by 
pesticide registrants. Limiting our focus to these compounds was 
intended to gain the greatest benefits of protection to bees with the 
least impact to growers. The agency will assess each compound under the 
registration review program, with a more thorough and robust data set 
as identified in our Risk Assessment Framework for Pollinators. As a 
result, additional chemical-specific, risk-based labeling will be 
developed based upon the results of these subsequent assessments.
    As part of its planning and analysis prior to issuing the proposal, 
the EPA considered the potential cost to growers. The agency is 
currently reviewing the wide range of comments it received in response 
to the proposal and is considering how to proceed. Based upon the 
comments received, we are developing options on moving forward. 
Throughout this process, the agency continues to weigh both the level 
of protection to bees, and the potential cost to growers.

    Question 4. I'm sure you're aware of the advances residue-detecting 
technologies have made, with some being able to detect parts-per-
billion. With this kind of preciseness, a tolerance-restricted 
pesticide could be found on an unrelated crop in a negligible but 
detectable amount, say by way of cross breezes or other unintentional 
factors. Is EPA taking this into consideration, to ensure that 
incidents such as these do not condemn an entire crop?
    Answer. The EPA is aware of the issues associated with the stated 
concern and note that enforcement questions related to the presence in 
or on food of a pesticide chemical residue for which there is no 
established EPA tolerance or tolerance exemption is under the purview 
of the U.S. Food and Drug Administration (FDA), not the EPA. Questions 
regarding the FDA's practices with respect to testing and enforcement 
activities related to low level pesticide chemical residues found in or 
on food should be directed to the FDA.

    Question 5. Some special interest groups have been demanding that 
the EPA now operate outside its existing FIFRA scope and regulate pre-
treated seeds. Given that there is still no solid scientific evidence 
to necessitate a change in oversight does the EPA intend to continue 
respecting this distinction?
    Answer. With respect to the litigation filed by public interest 
groups, on March 14, 2016, the EPA filed a motion with the district 
court in the Northern District of California to dismiss the case 
against the EPA. A hearing on this motion was held on May 12, 2016, and 
the following day the court issued an order deferring a decision on the 
merits of the EPA's motion to dismiss until the EPA produced an 
administrative record. The EPA has complied with the court's order and 
expects the court to address its jurisdiction (the subject of the 
motion to dismiss) during summary judgment proceedings. Under the 
current litigation schedule, summary judgment motions are to be filed 
in September and should be argued in October 2016. Treated seeds that 
meet the requirements of the treated article exemption at 40 CFR Part 
152.25(a) are exempt from regulation under FIFRA and the EPA has not 
proposed to amend that regulation.
Question Submitted by Hon. Ted S. Yoho, a Representative in Congress 
        from Florida
    Question. Administrator McCarthy, it is my understanding that on 
October 27, 2015, FOIA request EPA-HQ-2016-000771 was submitted to EPA. 
This FOIA requests copies of communication from 2011 to the present 
between the U.S. Environmental Protection Agency, U.S. Food and Drug 
Administration and U.S. Department of Agriculture related to the 
biopesticide active ingredient banda de Lupinus albus doce (BLAD) and 
the end use product Problad Plus (EPA Registration Number 84876-1). It 
is my understanding no information related to this request has been 
provided or released to date. Can you explain any reasons for this 
delay? Can you provide an expected timeline when information should be 
released?
    Answer. The EPA responded to request EPA-HQ-2016-000771 and sent 
all requested records. This FOIA request is closed.
Questions Submitted by Hon. Mike Bost, a Representative in Congress 
        from Illinois
    Question 1. Resistance Management is a critical concern for all 
farmers. Corn farmers have experienced increasing resistance problems 
with using traited corn. Resistance has developed in weeds, and pests 
like Corn Rootworm. Soil Applied Insecticides are registered by EPA for 
use on corn, including corn with traits, and have been proven effective 
in controlling rootworm and also improving yields. Is EPA planning to 
restrict the use of Soil Applied Pesticides with traited corn?
    Answer. The EPA has not taken any regulatory actions to restrict 
the use of soil applied insecticides on corn. In response to signs of 
resistance to Bt traits in the corn rootworm, the EPA has developed 
new, more protective requirements designed to delay corn rootworm 
resistance to genetically engineered Bt corn. The EPA announced its new 
requirements in February 2016. As part of those requirements, the EPA 
is recommending against the use of soil applied insecticides for 
control of corn rootworm on corn rootworm traited corn except under 
limited circumstances and in consultations with experts. This 
recommendation is based on published scientific literature that 
indicates the use of soil applied insecticides for corn rootworm can 
present an additional resistance risk to Bt traits and on advice from 
the EPA's FIFRA Scientific Advisory Panel. Information and materials 
from this SAP meeting is available at https://www.epa.gov/sap/meeting-
materials-december-4-6-2013-scientific-advisory-panel [See Attachment 
17].

    Question 2. I am very concerned that EPA has not been coordinating 
with USDA on matters crucial to farmers and consumers regarding the 
importance of crop and environmental protection and on the economic 
benefits to farmers who use pesticides to protect their crop yields to 
feed America and the world. I understand that USDA has been willing to 
work with EPA. However, USDA is appropriately concerned about not being 
consulted about the calculation of the benefits provided to agriculture 
and farm production through the use of pesticides.
    For example, the Chief Economist at USDA sent a letter on April 6, 
2015, to EPA criticizing EPA for publishing an analysis on the 
economics of soybean production which USDA said was misleading, 
incomplete, incorrect, and that ``as a whole USDA disagrees with the 
assessment.''
    The letter further said that ``USDA is disappointed that EPA 
published the re-
port . . . without offering USDA an opportunity . . . to correct the 
misrepresentations of economic costs and benefits that underlie this 
report.'' I certainly agree with USDA that USDA and EPA need to work 
together and note that Federal regulations require that coordination or 
an opportunity for USDA to provide input to EPA if that determination 
would result in the suspension, cancellation, or change in 
classification of a pesticide.
    In August, USDA sent a second letter to EPA, signed by Sheryl 
Kunickis, Director of Research, Education and Economics, saying that 
the May 29, 2015, EPA proposal on mandatory pesticide label 
requirements would be especially harmful to ``numerous specialty crop 
farmers and the rural economics they contribute to across the U.S.'' 
USDA was also concerned about the fact that the EPA ``proposal has the 
potential to negatively impact . . . organic production . . . .''
    Consultations between EPA and USDA are required in the Federal 
Insecticide, Fungicide, and Rodenticide Act in sections 2 (minor uses), 
3 (minor uses), 4 (public health issues), and section 6 (suspensions, 
cancellations, imminent hazards; advance notice of EPA actions, and 
other FIFRA provisions mandate the opportunity for USDA input). Some 
consultations are required by regulation or OMB Circulars.
    For all of 2015 and through the date of your response in 2016, can 
you please describe in appropriate detail consultations, discussions, 
and meetings EPA has conducted with USDA on the above examples on the 
following types of actions: determinations of economic benefits to 
farmers, including specialty crop farmers, regarding the use of 
specific pesticides; label requirements and changes; issues related to 
minor crops; public health matters; and the consideration of decisions 
to restrict, limit, cancel, or suspend the use of pesticides?
    In your answers please include specific information including 
dates, participants, actions taken, and the outcome of those 
consultations, discussions, and meetings.
    Answer. The following provides some examples of the discussions the 
EPA has had with USDA from January 1, 2015, through March 15, 2016. 
These consultations are summarized in the table below.
    The EPA typically consults with USDA through the Office of Pest 
Management Policy (USDA-OPMP). OPMP then coordinates with other 
entities associated with USDA, including the Integrated Pest Management 
(IPM centers), as appropriate. For some reviews, therefore, the EPA is 
not in direct contact with all the participants. The EPA regularly 
coordinates and consults directly with USDA's Animal and Plant Health 
Inspection Service's (APHIS) Biotechnology Regulatory Services (BRS) on 
matters related to biotechnology and agriculture. Similarly, the EPA 
consults directly and regularly with Interregional Project 4 (IR-4) on 
matters related to uses of pesticides on minor crops (i.e., crops grown 
on less than 300,000 acres). In addition, for the past several years, 
the EPA has scheduled monthly meetings with OPMP to provide for 
coordination on a wide variety of pesticide regulatory matters.
    The EPA and BRS coordinate on genetically-engineered (GE) crops 
which are resistant to herbicides and insects. In addition, EPA and BRS 
coordinate on GE microorganisms. The EPA has also coordinated closely 
with USDA-APHIS-BRS on the registration of herbicides containing 
rimsulfuron and nicosulfuron designed for use on Inzen sorghum (Inzen 
sorghum is a type of sorghum that is conventionally bred to be 
resistant to the effects of rimsulfuron and nicosulfuron herbicides). 
The registration of these herbicides could benefit sorghum growers who 
cultivate the Inzen sorghum line by providing improved weed control. 
Although Inzen sorghum is the product of conventional breeding and is 
not a GE crop, the EPA reached out to BRS. BRS assisted with an 
analysis which showed the potential for resistant trait conventionally 
bred into the sorghum to cross with wild relatives which could become 
resistant to the herbicides that are proposed for use on Inzen sorghum 
and subsequently pose challenges to their control in agricultural 
production. The EPA issued these registrations on February 3, 2016.
    USDA and HHS reviewed the EPA's assessment of an application for a 
new use of deltamethrin for the purpose of mosquito control. The review 
was led by USDA-OPMP (Office of Pest Management Policy), but the 
participating offices are not known. No comments were submitted. EPA 
found that the proposed use was a `minor use' as defined by FIFRA 
2(ll)(2), `lack of economic incentive.' As such, the registrant was 
eligible for a new period of exclusive use over the data submitted in 
support of the registration.
    In addition to consultations over specific pesticides, the EPA 
engages with USDA over basic concepts that contribute, over time, to 
pesticide decisions. USDA also reviews rules proposed and finalized by 
EPA under FIFRA and as part of the inter-agency review coordinated by 
the Office of Management and Budget. For example:

   The EPA has been collaborating with USDA, as well as FWS and 
        the National Marine Fisheries Service (NMFS) to develop interim 
        scientific methods to assess the potential risks of pesticides 
        to Federally endangered and threatened species and designated 
        critical habitats, based on recommendations from the April 2013 
        National Academy of Sciences report, ``Assessing Risks to 
        Endangered and threatened Species from Pesticides.'' 
        Specifically, USDA has provided expertise on pesticide uses for 
        the draft pilot Biological Evaluation for diazinon and 
        assistance with the use of the National Agricultural Statistics 
        Service Cropland Data Layer to help define the footprint of 
        agricultural use patterns;

   The EPA is in regular communication with USDA regarding 
        biotechnology per the Federal Coordinated Framework for the 
        Regulation of Biotechnology. For over 15 years, the EPA, USDA, 
        and FDA have participated in monthly biotechnology calls where 
        each agency shares regulatory updates, hot topics, and 
        information on international activities. The EPA, FDA, and 
        USDA-APHIS-BRS also have Memoranda of Understanding in place 
        regarding coordination and information sharing as well as other 
        MOU's associated with specific topic areas, e.g., coordination 
        and collaboration on the potential environmental release of GE 
        microorganisms. Additionally, through the Emerging Technologies 
        Interagency Policy Coordination Committee, the EPA is working 
        with USDA on updating the coordinated framework for 
        biotechnology;

   For over three years, the EPA has been in regular 
        communication with USDA-ARS regarding corn rootworm resistance 
        management issues. During the corn growing season, the EPA 
        participates in monthly conference calls with corn rootworm 
        entomologists, including USDA researchers. The EPA received 
        comments from USDA's OPMP (EPA-HQ-OPP-2014-0805-0076) in 
        response to its solicitation for public comment on a corn 
        rootworm mitigation strategy. The EPA modified its proposal to 
        account for those comments and comments from others. Prior to 
        releasing the proposed draft strategy and prior to announcing 
        an agreement in January 2016, the EPA communicated with OPMP to 
        notify OPMP of the release;

   The EPA is consulting with USDA-ERS (Economic Research 
        Service) to better understand the value of pollinators, 
        especially managed honey bees, and how pesticide use may 
        influence the habitat for wild pollinators. This information 
        will help the EPA better characterize the risks pesticides pose 
        to managed and wild pollinators;

   USDA reviewed the final rule to revise the Worker Protection 
        Standard (WPS) and the proposed rule revising the standards for 
        Certified Applicators. The review was coordinated by USDA-OPMP. 
        The Animal and Plant Health Inspection Service (USDA-APHIS) and 
        Forest Service (USDA-FS) participated significantly in the 
        review of the Certified Applicators proposed rule; both 
        entities run certification programs. An outcome of the 
        discussion with USDA was that the EPA expanded the definition 
        of farms and familial relationships eligible for the owner and 
        immediate family exemptions to the WPS;

   The EPA and USDA have been coordinating closely for several 
        years on the important issue of herbicide resistance. Weed 
        resistance to herbicides has become a major economic and 
        agronomic problem in U.S. agriculture in field crops such as 
        corn, soybeans, cotton, and wheat, as well as minor and 
        specialty crops. The EPA has proactively engaged USDA-OPMP and 
        USDA-APHIS's Biotechnology Regulatory Service (APHIS-BRS) in 
        this key area. This joint effort also includes the Weed Science 
        Society of America (WSSA) and other stakeholders, where in 
        2012, WSSA published two special editions of their Journal of 
        Weed Science that were the culmination of collaboration between 
        EPA, USDA and WSSA. In addition to weed resistance to 
        herbicides, the EPA is working with USDA and other stakeholders 
        in efforts to manage insect and plant pathogen resistance to 
        pesticides; and

   The EPA, USDA-OPMP, and USDA-APHIS-BRS have on several 
        occasions participated jointly in a wide range of outreach and 
        education efforts. In July 2015 the EPA and OPMP participated 
        in a tour of herbicide-resistant weed problems in Iowa 
        agriculture. Joining the group were weed scientists from the 
        University of Kentucky and Iowa State University. In other 
        outreach activities, USDA/OPMP joined EPA to discuss herbicide 
        resistance and other issues of mutual interest at a meeting 
        with the Commodity Research and Opportunities Partnership 
        (CROP), an organization that represents corn, cotton, wheat, 
        sorghum, and soybean growers.

    While the EPA does not have detailed records of every consultation 
held with USDA regarding pesticide regulatory matters, the following 
table provides examples of the wide variety of interactions between the 
EPA and USDA over the past 2 years:

------------------------------------------------------------------------
       Subject             Meeting Dates             Participants
------------------------------------------------------------------------
                    Pesticide-specific consultations
------------------------------------------------------------------------
Rimsulfuron and        January 29, 2015;      USDA-APHIS-BRS
 Nicosulfuron           February 27, 2015
 registrations on
 sorghum
Sulfonylurea           May 27, 2015           USDA-OPMP
 herbicides
Deltamethrin minor     Draft reviewed by      USDA-OPMP
 use assessment         USDA and HHS,
                        October-November,
                        2015
Neonicotinoid          April 30, 2015,        USDA-OPMP; USDA-IR-4
 insecticides           presentation by
                        AgInfomatics on
                        benefits
------------------------------------------------------------------------
                           Endangered Species
------------------------------------------------------------------------
Endangered Species     Continued discussions  USDA-OPMP, USDA-NASS
 Risk Assessments for   from January 1, 2015
 Pesticides             to present including
                        bi-weekly conference
                        calls and a week-
                        long interagency
                        workshop with EPA,
                        FWS, and USFWS in
                        January 2016
Federal Endangered     July 14, 2015          USDA-OPMP, USDA-NASS
 Species Task Force
 (FESTF) meeting
------------------------------------------------------------------------
                              Biotechnology
------------------------------------------------------------------------
Biotechnology          Monthly for 15+ years  EPA, USDA, FDA
 Coordination Calls
Discussion of USDA-    March 10, 2016         EPA, USDA-FAS
 FAS' mission, new
 breeding
 technologies and how
 the products may
 impact trade in
 agricultural
 commodities.
Biotechonology MOUs    On-going discussions   EPA, USDA-APHIS-BRS
Working with USDA on   August 2015 and        EPA, USDA-APHIS, USDA-OSEC
 the Emerging           ongoing discussion
 Technologies
 Interagency Policy
 Coordination
 Committee to update
 the coordinated
 framework for
 biotechnology
Corn Rootworm          Monthly during corn    EPA, USDA ARS
 Resistance             growing season for
 Management             3+ years
------------------------------------------------------------------------
                               Pollinators
------------------------------------------------------------------------
Value of pollinators   September 2, 2015,     USDA-ERS
                        and on-going
                        discussions
Pollinator habitat     December 1, 2015, and  USDA-ERS
                        on-going discussions
Pollinator health      As needed since May    USDA-OSEC, USDA-OPMP, USDA-
 task force             2014 (EPA and USDA     ARS, USDA-FSA, USDA-NRCS
                        co-chair the task
                        force)
------------------------------------------------------------------------
                                  Rules
------------------------------------------------------------------------
Worker Protection      May to July, 2015      USDA-OPMP
 Standard revisions
Certified Applicator   April to July, 2015    USDA-OPMP, USDA-APHIS,
 revisions                                     USDA-FS
------------------------------------------------------------------------
                          Herbicide Resistance
------------------------------------------------------------------------
Herbicide Resistance   March 16, 2015,        USDA-OPMP
 Internationally        seminar by Dr. Steve
                        Powles, University
                        of Western Australia
Herbicide Resistance   September 24, 2015,    USDA-OPMP
 Management             with WSSA
                        representatives       USDA-APHIS-BRS
                       October 23, 2015
Herbicide Resistance   February 10, 2016,     USDA-OPMP
 Management Proposal    Weed Science Society  USDA-OPMP, USDA-ARS, USDA-
                        of America             NRCS, USDA-NIFA, USDA-
                       March 16, 2016,         NASS, USDA-IR-4
                        Federal IPM
                        Coordinating
                        Committee meeting
------------------------------------------------------------------------
                             Methyl Bromide
------------------------------------------------------------------------
Golden nematode--      September 22, 2015     USDA-APHIS, EPA--Region 10
 conference call to
 discuss alternatives
 for quarantine and
 control in Idaho
------------------------------------------------------------------------
                           Outreach/Education
------------------------------------------------------------------------
Iowa Crop Tour on      July 7-10, 2015        USDA-OPMP
 herbicide resistant
 weeds
Interagency Meeting    February 10, 2016      USDA-APHIS-BRS, USDA-OPMP
 on weed control
 issues
Commodity Research &   October 8, 2015        USDA-OPMP
 Opportunities
 Partnership (CROP)--
 representing corn,
 cotton, wheat,
 sorghum, and soybean
 growers
Discussion with USDA   September 9, 2015      USDA-APHIS-BRS
 on Sorghum-
 Johnsongrass Gene
 Flow Seminar &
 Persistence of Crop
 Alleles in the Weed
 Populations
Webinar with Tribal    June 11, 2015          USDA-APHIS-BRS
 Nations on
 Genetically
 Engineered crops
Glyphosate resistance  July 14, 2015          USDA-ERS
 economics (webinar)
USDA Stakeholder       March 12-13, 2015      USDA-OPMP
 Workshop on
 Coexistence--resista
 nce management for
 biopesticides and
 herbicides
Sulfonylurea           April 1, 2015          USDA-OPMP
 herbicide meeting
 with registrants
Golden nematode--      September 22, 2015     USDA-APHIS, EPA--Region 10
 conference call to
 discuss alternatives
 for quarantine and
 control in Idaho
------------------------------------------------------------------------


    Question 3. Reliable data and analyses are critical to sound 
regulation. I have heard about a serious matter regarding EPA policies 
based on human research data that may not be reliable.
    For years, EPA relied on hundreds of quality studies evaluating all 
aspects human susceptibility to pesticides called organophosphates. 
This included studies designed to make sure that children would be 
protected. Even though EPA used those high-quality assessments for 20 
years the Agency now relies primarily on three epidemiology studies and 
some journal articles. Limiting the diversity of data creates a greater 
likelihood of inaccurate results. Why has EPA changed this process? Has 
limiting the number of studies increased the likelihood of inaccurate 
assessments? Was this change reviewed by a Scientific Advisory Panel? 
Was it subject to notice and public comment? Why is the Agency keeping 
this data from the public?
    Answer. The EPA periodically reviews existing registered pesticides 
to ensure they can be used safely, without unreasonable risks to human 
health and the environment. The periodic review of pesticide 
registrations is required by FIFRA. The registration review program is 
intended to make sure that, as the ability to assess risk evolves and 
as policies and practices change, all registered pesticides continue to 
meet the statutory standard of no unreasonable adverse effects. The EPA 
will review each registered pesticide at least every 15 years to 
determine whether it continues to meet the FIFRA standard for 
registration.
    As part of registration review, the EPA assesses any changes that 
have occurred since the last registration decision to determine whether 
the pesticide still satisfies the statutory standard for registration. 
The EPA considers any new data or information on the pesticide and 
decide whether a new risk assessment must be conducted. In the case of 
chlorpyrifos and the organophosphate pesticides, many of the 
epidemiology studies, mechanistic studies, and laboratory animal 
studies on the neurodevelopmental effects of organophosphate pesticides 
were published after reregistration was completed in 2006.
    The EPA developed a ``Draft Framework for Incorporating Human 
Epidemiologic & Incident Data in Health Risk Assessment'' in 2010 which 
was reviewed by the FIFRA SAP and received public comment. The Panel 
commended the agency for developing the draft Framework and was 
``impressed with the documentation presented.'' The agency also notes 
that the Panel was supportive of the key components of the draft 
Framework, namely the use of problem formulation to assess data 
availability and quality early in the process and the modified Bradford 
Hill criteria as an internationally accepted tool for assessing 
epidemiology and laboratory animal data.
    The agency has not limited the number of studies reviewed. In fact, 
the agency has reviewed hundreds of studies from laboratory animals, 
cell systems (including human), biomonitoring, and epidemiology on a 
variety of scientific areas related to human health effects. These 
studies were evaluated together in a weight of evidence analysis.
    Therefore, there is significant new information relevant to the 
human health effects of organophosphate pesticides.

    Question 3a. I have recently been told that one of the studies that 
the EPA relies upon was conducted by Columbia University and that they 
have refused to provide the raw data to the Agency even though EPA 
partially funded the study. Is that true? At any point has EPA been 
allowed to review the raw data? Do you believe that its use is in 
compliance with the Administrative Procedures Act? How many times has 
this study been utilized for registrations and registration reviews? 
Was that study and its underlying data reviewed by a Scientific 
Advisory Panel? Was it subject to notice and public comment?
    Answer. The EPA frequently relies on peer reviewed studies in the 
public literature across agency programs without possessing underlying 
data and the Federal courts have made clear that the EPA is not 
required by Federal law to obtain or analyze the raw data in order to 
rely on such studies. The EPA therefore believes its consideration of 
these data is consistent with the Administrative Procedure Act. If the 
EPA and other governmental agencies could not rely on published studies 
without conducting independent analyses of the raw data underlying 
them, then much relevant scientific information would become 
unavailable for use in setting standards to protect public health and 
the environment.
    In the past, the EPA sought to obtain the original raw data used to 
support certain epidemiological analysis of in utero exposure to 
chlorpyrifos and subsequent adverse neurodevelopmental health outcomes 
in children generated by the Columbia Center for Children's 
Environmental Health (CCCEH) to support the human health risk 
assessment of chlorpyrifos. Prior to the 2013 meeting with CCCEH 
investigators, the EPA thought these data would be important to both 
clarify the exposure-response relationship observed in the epidemiology 
study relative to the current regulatory endpoint (acetylcholinesterase 
inhibition), and also to resolve uncertainties regarding study 
participants co-exposure to other environmental contaminants, among 
other areas of uncertainties. CCCEH researchers did not agree to 
provide these data; however, the researchers met with the EPA and 
discussed the agency's questions about the data to help determine 
whether further review of the raw data might assist the EPA in 
resolving uncertainties. As a result of this meeting, the EPA concluded 
that access to the raw data would not provide answers to the EPA's 
questions. Indeed, based on discussions in that meeting as well as 
further work conducted by agency staff, the EPA has gained additional 
information to better clarify and characterize the major issue areas 
identified as uncertainties.
    In the summer of 2015, the EPA made another attempt to obtain the 
raw data from Columbia University. The Columbia University 
investigators again denied the EPA's request. However, the 
investigators did provide additional summary information on the blood 
biomonitoring data. The agency has made this additional information 
publicly available.
    Also in summer of 2015, Dr. Dana Barr of Emory University provided 
the agency with limited raw data in her possession from the three 
cohorts. However, the files provided from Dr. Barr are not useful the 
agency's current purpose of assessing risk to chlorpyrifos. The files 
provided from Dr. Barr do not contain the biomonitoring data from the 
key publications from CCCEH which describe associations between blood 
levels of chlorpyrifos and neurodevelopmental deficits in children. The 
agency has received two FOIA requests specifically asking for raw data 
on the three US children's cohorts. For the first FOIA request, EPA-HQ-
2016-002089, the requester was provided all the responsive records 
(i.e., the files provided by Dr. Barr) and the request was closed March 
2, 2016. For the second request, EPA-HQ-2016-003947, the agency did not 
have any additional files beyond those provided for the first request. 
The second FOIA was closed on March 22, 2016.
    The agency has taken a stepwise, objective and transparent approach 
in evaluating, interpreting, and characterizing the strengths and 
uncertainties associated with all of the available lines of scientific 
information related to the human health effects of chlorpyrifos. This 
stepwise approach has included multiple reviews by the FIFRA SAP and 
other experts in addition to multiple opportunities for public comment.
    The stepwise evaluation began with the September 2008 FIFRA SAP 
meeting involving a preliminary review of the literature for 
chlorpyrifos, with a particular focus on women and children (USEPA, 
2008). In 2010, the EPA developed a draft ``Framework for Incorporating 
Human Epidemiologic & Incident Data in Health Risk Assessment'' which 
provides the foundation for evaluating multiple lines of scientific 
evidence, including epidemiology, in the context of the understanding 
of the adverse outcome pathway (or mode of action (USEPA, 2010). The 
draft framework, which includes two key components: problem formulation 
and use of the modified Bradford Hill criteria, was reviewed favorably 
by the SAP in 2010 (FIFRA SAP, 2010). The EPA's draft framework is 
consistent with updates to the World Health Organization/International 
Programme on Chemical Safety mode of action/human relevance framework, 
which highlight the importance of problem formulation and the need to 
integrate information at different levels of biological organization.
    Because the SAP was basically supportive of the overall approach 
and the framework is consistent with recent, similar efforts by the 
WHO, the agency believes use of the draft framework in its current form 
is appropriate prior to the finalization of the document. The EPA used 
the draft framework for the 2014 chlorpyrifos revised risk assessment 
and the preliminary risk assessment for seven organophosphates in 2015. 
Currently, we are incorporating comments from the SAP and the public, 
and plan to finalize the framework in 2017.
    In 2011, the agency released ``Chlorpyrifos: Preliminary Human 
Health Risk Assessment for Registration Review,'' focusing on the AChE 
inhibiting potential of chlorpyrifos (USEPA, 2011) and included 
assessment of exposures from dietary (food, water), occupational and 
residential pathways. The 2011 preliminary risk assessment was released 
for public comment. Also in 2011, the chlorpyrifos physiologically 
based pharmacokinetic-pharmacodynamic model (PBPK-PD) was reviewed by 
the FIFRA SAP (FIFRA SAP, 2011). [This model was used in the 2014 
revised human health risk assessment described below.]
    In 2012, the agency convened another meeting of the FIFRA SAP on 
chlorpyrifos which incorporated the newest experimental data related to 
AChE inhibition and both cholinergic and non-cholinergic adverse 
outcomes, including neurodevelopmental studies on behavior and 
cognition effects (FIFRA SAP, 2012). Similarly, the agency also 
performed a more in-depth analysis of the biomonitoring data and of 
epidemiological studies from three major children's health epidemiology 
cohort studies in the U.S., as well as developed plausible hypotheses 
on MOAs/AOPs leading to neurodevelopmental outcomes (USEPA, 2012a). 
Following the 2012 SAP meeting, the agency solicited additional input 
from Federal experts in the areas of Magnetic Resonance Imaging (MRI) 
and neurobehavioral testing in children to further clarify results 
obtained by examination of the epidemiological studies.
    In December, 2014, the agency released ``Chlorpyrifos: Revised 
Human Health Risk Assessment for Registration Review'' * which went 
through public comment in 2015.
---------------------------------------------------------------------------
    * Editor's note: the document referred to is retained in Committee 
file.
---------------------------------------------------------------------------
    Similarly, the agency's ``Literature Review on Neurodevelopment 
Effects & FQPA Safety Factor Determination for the Organophosphate 
Pesticides'' was released for public comment in September, 2015.
    The agency held another meeting of the FIFRA SAP in April 2016, to 
review a new analysis using the blood biomonitoring data from the 
Columbia University epidemiology study.

    Question 3b. It has also been brought to my attention that one of 
the authors of the study, Frederica Perera, Dr.P.H., Ph.D., of the 
Columbia University School of Public Health, is a member of the Board 
of Trustees of the Natural Resources Defense Council. The Natural 
Resources Defense Council has sued the EPA on a number of occasions to 
challenge pesticide registrations and often the supporting risk 
assessments. Has the EPA's Office of Inspector General been made aware 
of this conflict of interest? Has the Agency suspended use of the 
Columbia University epidemiology study in its risk assessment process 
until these concerns can be addressed?
    Answer. While recipients of Federal grants are subject to conflict 
of interest rules designed to insure that the competition for grants is 
fair and that the use of grant funds is appropriately managed, they are 
not otherwise subject to conflict of interest restrictions 
disqualifying them from eligibility to receive a grant based on 
affiliations with organizations that have sued the agency or supported 
particular regulatory activities. Accordingly, the EPA has not related 
this matter to the EPA Inspector General, nor has the EPA suspended its 
consideration of these data.

    Question 3c. If it is correct that EPA has not gotten access to 
that raw data, Federal regulations designed to enhance the credibility 
of the Federal rulemaking process have likely been violated. Data 
Quality Act violations and conflict of interest violations may have 
also occurred.
    Answer. The EPA frequently relies on peer reviewed studies in the 
public literature across agency programs without possessing underlying 
data and the Federal courts have made clear that the EPA is not 
required by Federal law, including Federal rulemaking procedures, to 
obtain or analyze the raw data in order to rely on such studies. If EPA 
and other governmental agencies could not rely on published studies 
without conducting independent analyses of the raw data underlying 
them, then much relevant scientific information would become 
unavailable for use in setting standards to protect public health and 
the environment.
    The EPA's consideration of epidemiological data supporting the 
EPA's chlorpyrifos assessment is in keeping with the EPA's guidelines 
implementing the Information Quality Act. Those guidelines recognize 
that in some circumstances complete access to all methods and data 
cannot occur due to privacy, trade secrets, intellectual property, and 
other confidentiality protections. In those instances, EPA guidelines 
provide that the EPA should, to the extent practicable, apply 
especially rigorous robustness checks to analytic results and carefully 
document all checks that were undertaken. Original and supporting data 
may not be subject to the high and specific degree of transparency 
provided for analytic results; however, the EPA should apply, to the 
extent practicable, relevant agency policies and procedures to achieve 
reproducibility, given ethical, feasibility, and confidentiality 
constraints.
Questions Submitted Hon. David Rouzer, a Representative in Congress 
        from North Carolina
EPA National Enforcement Initiatives
    Question 1. One of EPA's current enforcement initiatives for the 
Fiscal Years 2014-2016 expands enforcement action against our nation's 
animal agriculture operations. EPA is currently undergoing a process to 
modify the NEIs and this presents an opportunity that we support--
returning this priority to the standard enforcement program--which is 
prudent considering the current NEI has not produced demonstrable water 
quality benefits. Administrator McCarthy, will you work to ensure that 
the new enforcement initiatives are based on sound science and 
demonstrated environmental benefits, rather than a doubling-down of 
efforts that have only acted to generate further distrust of EPA by 
America's farmers and ranchers?
    Answer. The EPA identifies National Enforcement Initiatives based 
on public and stakeholder input, as well as extensive science-based 
analysis about public health threats from pollution. We recently 
announced the EPA's selection of the FY 2017-2019 National Enforcement 
Initiatives. Building on progress we've made from the current cycle of 
initiatives, the EPA determined that to protect American communities, 
it was important to retain its national initiative to prevent animal 
waste from contaminating surface and ground water. This will help focus 
important time and resources on protecting communities from improperly 
managed animal waste, which can result in water quality impairment, 
fish kills, algal blooms, contamination of drinking water sources, and 
transmission of disease-causing bacteria and parasites associated with 
food and waterborne diseases.
NPDES Electronic Reporting Rule
    Question 2. This rule (finalized by EPA on September 25, 2015) will 
result in EPA collecting farm information from states that goes beyond 
the scope of the Federal program. Taking into account EPA's accidental 
release of farm information to environmental activist groups in 2013, 
the lack of data security measures to prevent EPA from collecting non-
NPDES farm information is very concerning to our nation's farmers and 
ranchers. Administrator McCarthy, can you ensure us that no superfluous 
information will be collected by the EPA through the electronic 
reporting rule?
    Answer. The minimum set of NPDES program data that the EPA will 
collect through the NPDES Electronic Reporting Rule does not go beyond 
the scope of the Federal program and is based on the EPA's current 
reporting requirements (see Appendix A to 40 CFR Part 127) [See 
Attachment 7].
    During the development of this rulemaking the EPA carefully 
considered input from authorized state programs, provided in comments 
and meetings, to match the minimum set of NPDES program data to the 
existing regulations and practice, including how these data are 
currently used by the EPA and authorized state programs. The EPA, in 
close collaboration with the states, streamlined the NPDES electronic 
reporting requirements down to the minimum number of data elements 
needed to oversee management of the NPDES programs in the most 
efficient manner possible. In particular, these data are necessary to 
properly identify potential sources of wastewater and storm water 
pollution and to assess the effectiveness of authorized NPDES programs.
    In particular, the EPA worked with authorized NPDES programs to 
ensure that the final rulemaking accurately captures EPA's existing 
Federal NPDES reporting requirements on Concentrated Animal Feeding 
Operations [e.g., 40 CFR Part 122.21(i)(1), 122.23, and 122.42(e)(4)]. 
Additionally, besides inspection information, authorized state programs 
are only required to share with the EPA data on facilities that are 
required to obtain NPDES permits under Federal requirements.

    Question 3. Last September, the EPA published Interim 
Recommendations for environmental standards and ecolabels for use in 
Federal procurement. EPA's recommendation for lumber excludes several 
credible standards that are widely used in the United States, including 
the Sustainable Forestry Initiative (SFI) and American Tree Farm System 
(ATFS) standards, which represent 70% of the certified acres in the 
U.S. EPA has signaled that this recommendation is mandatory for Federal 
procurement. Under what circumstances may a Federal procurement officer 
purchase wood products that do not meet this FSC requirement, such as 
those certified to SFI or ATFS? And, given the significant volume of 
sustainably harvested timber that is seemingly excluded from Federal 
purchasing, please explain the process for EPA amending this 
recommendation in the future.
    Answer. Under Executive Order 13693--Planning for Federal 
Sustainability in the Next Decade--the EPA issued recommendations to 
assist Federal purchasers in identifying and procuring environmentally 
sustainable products. The EPA's Interim Recommendation for the lumber/
wood category is based on the Department of Energy's Fiscal Year 2016 
(FY16) Priority Products List.
    As a result of stakeholder inquiries since the release of the 
Interim Recommendation, the EPA has met and is continuing to work with 
USDA and DOE's Office of Sustainable Environmental Stewardship to gain 
further information. The EPA's Standards Executive is reaching out to 
the Sustainable Forestry Initiative, the American Tree Farm System, and 
the other forestry labels that stakeholders have requested the EPA 
consider. The EPA will be in touch with these groups regarding the 
agency's review of forestry labels and their alignment with the 
National Technology Transfer and Advancement Act, the OMB Circular A-
119, and related Federal policies that guide the EPA's use of voluntary 
consensus standards and private-sector conformity assessment 
activities. In addition, the EPA continues to progress with piloting 
our Guidelines for Assessing Standards and Ecolabels for Use in Federal 
Procurement (the Guidelines), and hopes that information gleaned from 
this process will inform thinking related to the lumber/wood category. 
Finally, DOE continues to conduct research to inform their FY16 
Priority Products List. The EPA looks forward to reviewing all of this 
additional data to inform if and how the lumber/wood category of 
Interim Recommendations might be revised.
    The EPA has, and will continue to provide, mechanisms for public 
input as we develop these recommendations. The agency issued Federal 
Register Notices on the initial draft guidelines in 2014 and in March 
2015 for the launch of our pilot work.\10\ Those FRNs were open to 
public comment and they marked the beginning of our efforts to engage 
multi-stakeholder panels whose counsel will be considered as we move to 
finalize our recommendations. Further, any Federal acquisition 
requirements stemming from the recommendations would include a public 
comment process prior to incorporation into the Federal Acquisition 
Regulations (FAR). As such, FAR Case 20 15-033 has been developed in 
order to integrate the new requirements of E.O. 13693 into the FAR. All 
next steps related to this case, including as to when it will be 
available to the public, are viewable at http://www.acq.osd.mil/dpap/
dars/far_case_status.html.
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    \10\ Federal Register Notice, February 27, 2014, ``Draft Guidelines 
for Product Environmental Performance Standards and Ecolabels for 
Voluntary Use in Federal Procurement'' (79 FR 11102). [See Attachment 
1] https://www.gpo.gov/fdsys/pkg/FR-2014-02-27/pdf/2014-04329.pdf.
    Federal Register Notice, March 19, 2015, ``Agency Information 
Collection Activities; Proposed Collection and Comment Request; 
Assessment of Environmental Performance Standards and Ecolabels for 
Federal Procurement'' (80 FR 14372). [See Attachment 2] https://
www.gpo.gov/fdsys/pkg/FR-2015-03-19/pdf/2015-06275.pdf.

    Question 4. President Obama stated on January 21, 2009 that ``The 
Freedom of Information Act should be administered with a clear 
presumption: In the face of doubt, openness prevails. . . . All 
agencies should adopt a presumption in favor of disclosure, in order to 
renew their commitment to the principles embodied in FOIA, and to usher 
in a new era of open government. The presumption of disclosure should 
be applied to all decisions involving FOIA.''
    However, on September 10, 2015, a Federal district court opinion 
issued September 10, 2015, noted that EPA ``continues to demonstrate a 
lack of respect for the Freedom of Information Act process . . . .'' 
``The Court is left to wonder whether EPA has learned from its mistakes 
or if it will merely continue to address FOIA requests in the clumsy 
manner that has seemingly become its custom. Given the offensively 
unapologetic nature of EPA's recent withdrawal notice, the Court is not 
optimistic that the Agency has learned anything.''
    In addition, a recent (January 2016) report of the House Committee 
on Oversight and Government Reform strongly criticized the failure of 
Federal agencies to properly implement FOIA. Major problems included 
long delays and redacting information that should be made public. 
Improper redaction is a very serious ``invisible'' problem since FOIA 
requesters cannot determine if the Agency is following the law. What 
specific steps will EPA undertake to do a better job in responding to 
FOIA requests?
    Would you support legislation providing independent agencies--such 
as the Inspector General offices of the various Departments--the 
authority to confidentially sample FOIA responses and determine if the 
Agency is improperly redacting material? In my view, that is likely to 
be the only way to determine if an Agency is complying with the law 
regarding redactions.
    Answer. The EPA takes its FOIA responsibilities seriously and is 
focused on creating more efficient work processes to ensure FOIA 
responses are prepared effectively and at lower cost. This includes 
adopting industry best practices for the delivery of information 
technology services in areas such as cloud computing, mobile technology 
and workplace standards. The EPA received close to 11,000 new FOIA 
requests in FY 2015 and successfully processed over 11,000 requests, 
reducing its FOIA backlog by several hundred requests.
    The EPA also has improved its records management policies and 
procedures, including recent updates to the Records Management Policy 
(https://www.epa.gov/sites/production/files/2015-03/documents/cio-
2155.3.pdf) [See Attachment 18] and new procedures to assist employees 
in the management of various types of electronic records. In addition, 
the agency's FOIA Expert Assistance Team was established in the fall of 
2015. The team, part of the Office of General Counsel, is charged with 
overseeing and coordinating efforts on the agency's most complex FOIAs. 
The EPA has also deployed new technology tools, such as centralized 
searching and electronic review, to efficiently process large or 
complex requests.
    The EPA already provides the Inspector General and Congress with 
information in non-redacted format upon request. In addition, the EPA 
has recently finalized the update of agency-wide and office level FOIA 
procedures to clarify roles and responsibilities for responding to 
requests, including line by line review and limited redaction.

    Question 5. Americans are at an increasing threat from vector-borne 
diseases. West Nile Virus and encephalitis have been serious problems 
for the last several years, but new diseases such as dengue fever and 
chikungunya are now an increasing threat to Americans and particularly 
infants. Sadly, new vector-borne threats continue to emerge. In Mexico 
and South America, the mosquito-borne Zika virus is responsible for 
infants being borne with significant birth defects. EPA is proposing 
very aggressive action to restrict the use of some critical mosquito 
control products. How is the Agency incorporating new public health 
threats into its risk assessments for products used in vector control?
    Answer. The EPA is not currently proposing any actions to restrict 
the use of mosquito control products. The agency has recently released 
preliminary risk assessments that show risks of concern for some 
compounds; however, these are preliminary in nature and subject to 
change if additional data come to light. When refined risk assessments 
still show a concern, changes in use patterns or applications can 
sometimes be effective in mitigating the risk and allowing the compound 
to still be used in mosquito control.
    When making a regulatory decision, the EPA considers the benefits 
(both public health and other) of these pesticides, along with their 
risks. The EPA consults with CDC when making a regulatory decision for 
any pesticide used to control a pest of public health significance. The 
EPA also frequently consults with other interested stakeholders to 
ensure that the agency has a complete picture of the benefits and have 
properly evaluated any proposed mitigation.

    Question 6. The Federal rulemaking process includes very specific 
actions that a Federal Agency must take before promulgating new 
regulations. Some recent activities by the Office of Pesticide Program 
appear to circumvent the rulemaking process by sending pesticide 
registrants letters that outline new regulatory provisions. This 
``regulation by letter'' procedure was used by EPA in 2013 to mandate 
registrants include pollinator statements and a graphic on certain 
pesticide products, and in 2009 for the Agency's pyrethroid and 
pyrethrin labeling initiative. What is EPA's rationale for 
circumventing the Administrative Procedure Act (APA), which includes 
notice and comment, economic and small business impact analysis, etc.? 
Will EPA provide the Committee with assurances that it will abandon 
this policy of ``regulation by letter'' and instead follow the 
procedures and analysis required by the APA?
    Answer. The EPA does not ``regulate by letter'' and FIFRA does not 
provide for such a regulatory mechanism to make changes to pesticide 
registrations. The EPA pesticide program is a licensing program that is 
based on an adjudicatory system. As a licensing program, the agency 
must ensure that the license complies with the law and continues to 
comply with the law. As such, decisions to grant a new license or 
change/modify an existing license are not subject to APA rulemaking, 
but the procedural requirements of FIFRA. When the EPA receives new 
information and determines that the license may lead to unreasonable 
adverse effects on the environment, the agency may offer the registrant 
a way to correct the imbalance in a timely manner. The August 2013 
letter regarding labeling changes for the neonicotinoid insecticides is 
one example. However, if the registrant chooses not to address the 
concerns raised in such an offer, the agency can take appropriate steps 
under FIFRA to compel any necessary changes to the pesticide 
registration to mitigate unreasonable adverse effects on the 
environment. The letter itself is not self implementing; in the absence 
of voluntary agreement from a registrant, FIFRA prescribes steps that 
the agency must take to impose new mitigation measures.

    Question 7. What farmers and communities in my district care about 
is the ability to defend against pest threats to their crops, food, 
homes and health. We have heard a lot today about what actions EPA has 
or is planning to take that impact the use of pesticides. I believe it 
would be very helpful to this Committee for EPA to develop a 
comprehensive list of all the Agency actions, and, not just 
rulemakings, during the last 8 years and those planned through the end 
of this year that restricted, or have the potential to restrict, 
existing or new uses of pesticides. Will you work with the Committee to 
determine what actions should be on that list so that Members can 
determine whether and how best to conduct appropriate oversight 
pursuant to our statutory obligations?
    Answer. The EPA routinely provides opportunities for public comment 
on many pesticide regulatory actions. For example, before registering a 
new active ingredient or a significant new use of an already-registered 
active ingredient, the EPA engages stakeholders through its public 
participation process. Similarly, all registration review activities, 
including work plans, risk assessments, and proposed decisions, are the 
subject of public comment periods to ensure that stakeholders can 
provide the EPA with the highly quality information needed to make 
pesticide regulatory decisions.
    The pesticide registration review process began in 2007 with the 
first decisions being made a few years later. To date, 165 decisions 
have been made. Of these decisions, 83 involved requests from the 
registrants to voluntarily cancel their registrations, in most cases 
for business decisions that were independent of the agency's review. 
For the remaining 82, many required no change to the registration or 
minor label clarification to make it easier for the user to understand 
and use the product correctly. Our anticipated registration review 
schedule can be found at www.epa.gov/pesticide-reevaluation/
registration-review-schedules [See Attachment 3].
    During the same time period, the EPA has registered approximately 
170 new pesticide active ingredients and more than 1,700 new uses of 
already registered active ingredients, providing numerous new products 
for use in agricultural and non-agricultural settings. These newly 
registered products are designed to address emerging pest pressures and 
will have a significant role in the marketplace.
    Of these regulatory decisions to restrict or cancel certain 
registrations, the EPA made these decisions after careful consideration 
of all available data and consistent with existing statutory 
requirements. For example:

   In 2010, the EPA announced its decision to terminate all 
        uses of endosulfan due to unacceptable risks to farmworkers and 
        wildlife. The EPA signed a Memorandum of Agreement with the 
        registrants of endosulfan that resulted in voluntary 
        cancellation and provided for a phase-out of all existing 
        endosulfan uses in the United States in order to allow time for 
        growers to transition to newer alternatives;

   In 2012, the EPA limited the use of chlorpyrifos by 
        significantly lowering pesticide application rates and creating 
        ``no-spray'' buffer zones around public spaces, including 
        recreational areas and homes, due to concerns for unacceptable 
        risks to children and bystanders;

   In 2014, the EPA canceled propoxur pet collars. In the fall 
        of 2013, the EPA completed the propoxur pet collar risk 
        assessment. The EPA's risk assessment indicated risks of 
        concern to children from exposure to pet collars containing 
        propoxur;

   In 2015, the EPA reached an agreement with Reckitt 
        Benckiser, the manufacturer, to cancel all distribution of 12 
        consumer use d-CON products that did not meet the EPA's current 
        safety standards, raising concerns for risks to children and 
        pets. Additionally, eight of the 12 products pose unacceptable 
        risks to certain wildlife;

   In 2015, the EPA proposed to revoke all chlorpyrifos 
        tolerances due to concerns with estimated exposure from 
        drinking water in certain watersheds. A final tolerance rule is 
        anticipated in March 2017;

   On November 24, 2015, while the issuance of the initial 
        registration was being challenged in Federal court, the EPA 
        sought the remand and vacatur of the Enlist Duo registration 
        because the EPA became aware of previously existing information 
        about possible synergistic effects that had not been provided 
        to the EPA or considered as part of the initial registration 
        decision. The EPA cannot be sure, without a full analysis of 
        the new information, that the current registration does not 
        cause unreasonable effects to the environment, which is a 
        requirement of the registration standard under FIFRA;

   On July 2, 2013, the Pollinator Stewardship Council and 
        others, petitioned for review of the sulfoxaflor registration 
        in the Ninth Circuit Court of Appeals. On September 10, 2015, 
        the Court issued its opinion, finding that the registration was 
        not supported by substantial evidence to demonstrate no 
        unreasonable adverse effects to honey bees would result from 
        the registration of [sulfoxaflor]. Although the initial 
        sulfoxaflor submission contained all the data the EPA 
        determined was necessary by the EPA for registration of a new 
        agricultural insecticide, the Court vacated the registrations 
        and remanded them to the EPA to ``obtain further studies and 
        data regarding the effects of sulfoxaflor on bees as required 
        by EPA regulations.'' The vacatur of the sulfoxaflor 
        registrations became effective November 12, 2015. As the 
        registrations were no longer in effect under FIFRA, on the same 
        date the EPA issued a cancellation order to address existing 
        stocks. Although the product registrations were vacated, the 
        tolerances for sulfoxaflor residues on treated commodities that 
        were established under the FFDCA, remain in place; and

   On March 4, 2016, the EPA issued a notice of intent to 
        cancel the registration of four pesticide products containing 
        the insecticide flubendiamide owing to the registrants' failure 
        to comply with a required condition of their registrations. The 
        particular condition obligated the registrants to request 
        cancellation if, after receiving additional required data, the 
        EPA determined that use of flubendiamide did not meet the FIFRA 
        standard for registration. Prior to issuing the notice, the EPA 
        concluded that the continued use of flubendiamide will result 
        in unreasonable adverse effects on the environment, 
        particularly benthic invertebrates, which are an important part 
        of the aquatic food chain, particularly for fish.

    Over the past 8 years, the EPA issued a number of regulations 
within the intention of providing clarity to the regulated community 
and other stakeholders or to update information that has become 
inaccurate or out of date. Examples of these rulemaking efforts 
include:

   Minimum Risk (Published 12/28/2015): This final rule more 
        clearly describes the active and inert ingredients permitted in 
        products eligible for the exemption from regulation for minimum 
        risk pesticides. These changes maintain the availability of 
        minimum risk pesticide products while providing more consistent 
        information for consumers, clearer regulations for producers, 
        and easier identification by states, Tribes and the EPA as to 
        whether a product is in compliance with the exemption;

   Crop Grouping (Published Phase 1: 12/7/2007; Phase 2: 12/8/
        2010; Phase 3 8/22/2012; Phase 4: anticipated 2016): These 
        final rules are likely to reduce the number of residue 
        chemistry studies required to establish a tolerance for a crop 
        within these crop groupings because instead of testing each 
        crop individually, only the representative crops would need to 
        be tested. Thus, the new crop groups ease the process for an 
        entity to request and for the EPA to set pesticide tolerances 
        on greater numbers of crops. Pesticides will be more widely 
        available to growers for use on crops, particularly specialty 
        crops;

   Data Requirements for Antimicrobials (158W) (Published 5/8/
        2013): the EPA revised the data requirements for antimicrobial 
        pesticide products to reflect current scientific and regulatory 
        practice, and to provide the regulated community with clearer 
        and transparent information about the data needed to support 
        pesticide registration decisions for antimicrobial products. 
        The EPA would use this information to conduct risk assessments 
        for a particular pesticide;

   Prions as Pests (Published 2/28/2013): In 2003, the agency 
        determined that a prion (proteinaceous infectious particles) is 
        a ``pest'' under the FIFRA and that a product intended to 
        reduce the infectivity of prions on inanimate surfaces (i.e., 
        ``prion product'') is considered to be a pesticide. The EPA 
        believes that regulating prion-related products protects human 
        health and the environment against unreasonable adverse effects 
        and ensures that such products are effective;

   Export Labeling (Published 1/18/2013; Revisions Published 
        12/19/2014): The EPA revised the regulations pertaining to the 
        labeling of pesticide products and devices that are intended 
        solely for export. Pesticide products and devices intended 
        solely for export are now able to meet the agency's export 
        labeling requirements by attaching a label to the immediate 
        product container or by providing collateral labeling that is 
        either attached to the immediate product being exported or that 
        accompanies the shipping container of the product being 
        exported at all times when it is shipped or held for shipment 
        in the United States. Collateral labeling ensures the 
        availability of the required labeling information, while 
        allowing pesticide products and devices that are intended 
        solely for export to be labeled for use in, and consistent with 
        the applicable requirements of the importing country; and

   Data Compensation (Published 2/5/2014): The EPA revised its 
        regulations governing procedures for the satisfaction of data 
        requirements under FIFRA, codified in 40 CFR part 152, subpart 
        E. These provisions include, among other things, procedures for 
        the protection of exclusive use and data compensation rights of 
        data submitters. The EPA updated the regulations to accommodate 
        statutory changes and changes in practice that have occurred 
        since 1984; to make minor changes to clarify the regulations; 
        and to make changes that would simplify the procedures and 
        reduce burdens for certain data submitters. The revisions did 
        not otherwise make substantive changes to the requirements.

    At times, however, the EPA has determined that significant changes 
to its regulations are needed to improve public health. For example, in 
November 2015, the EPA finalized revisions to the Agricultural Worker 
Protection Standard. This final rule revised the Federal regulations 
issued under FIFRA that direct agricultural worker protection (40 CFR 
170). The changes reflected current research on how to mitigate 
occupational pesticide exposure to agricultural workers and pesticide 
handlers, and strengthened the protections provided to agricultural 
workers and handlers under the worker protection standard. The changes 
improved elements of the existing regulation, such as training, 
notification, communication materials, use of personal protective 
equipment, and decontamination supplies, thus preventing exposure to 
pesticides among agricultural workers and pesticide handlers; 
vulnerable groups, such as minority and low-income populations, child 
farmworkers, and farmworker families; and the general public. We are 
working closely with affected stakeholders, including state 
agricultural agencies, to ensure that they have the necessary 
information and training to implement these new protections.
    Similarly, the EPA is now working to develop a final rule to revise 
the Federal regulations governing the certified pesticide applicator 
program (40 CFR part 171). This action is intended to improve the 
competence of certified applicators of restricted use pesticides (RUPs) 
and to increase protection for noncertified applicators of RUPs 
operating under the direct supervision of a certified applicator 
through enhanced pesticide safety training and standards for 
supervision of noncertified applicators. State agricultural agencies, 
as well as many other stakeholders, provided valuable comments and 
suggestions in response to the EPA's proposed rule. We will work with 
stakeholders to ensure that the revised competency standards can be 
implemented effectively by state agencies.
Questions Submitted by Hon. Ralph Lee Abraham, a Representative in 
        Congress from Louisiana
    Question 1. In response to my question about whether EPA treats 
herbicides used with crops improved through biotechnology differently 
than it treats all other herbicides, you stated that such herbicides 
``are not treated differently than looking at how we always look at 
pesticides, which is by the science trying to stick with the legal 
timelines and windows that we have to make our decisions.'' 
Furthermore, you indicated the Agency is reducing the number of 
renegotiation extensions overall under the Pesticide Registration 
Improvement Act. Yet it is my understanding that EPA has consistently 
imposed disproportionate burdens and delays on registration activities 
related to biotechnology that it does not impose on similarly situated 
products that are not related to biotechnology.
    Please provide this Committee with examples of registration 
timelines, including all applicable registration renegotiations (the 
number of times a PRIA date was renegotiated and for how long) that 
support your statement that registrations tied to biotech traits are 
completed in the same general timeframe from submission to final label 
as registrations with no biotech crop application.
    Answer. The EPA assesses risks and benefits for each pesticide 
registration application, striving to complete regulatory decisions 
within the timeframes designated under PRIA. The EPA employs the same 
process to review applications for herbicide uses on biotech crops as 
it does for other applications, identifying any risks of concern and 
conducting assessments to understand and address those risks. As with 
all applications, the EPA must address risk issues identified in the 
course of scientific review as well as comments received through the 
public participation process. Overall, the EPA has reduced the number 
of renegotiation extensions under PRIA. However, different chemicals 
and use patterns may present different risks, sometimes requiring more 
in depth and complex assessments to address them. More complex risks 
assessments may exceed average review timeframes in order to produce 
scientifically sound and legally defensible decisions.
    The most complex reviews for new registration can involve the 
review and evaluation of requests to register pesticides for use on 
herbicide tolerant crops. While the number of applications in recent 
years are small, the review times range from approximately 2 years to 
approximately 6 years. These review times depend upon many factors, 
including any risk concerns identified and the time needed to negotiate 
risk mitigation strategies to address any potential unreasonable 
adverse effects, the need to wait to make a registration decision under 
FIFRA until other agencies make necessary safety findings under other 
relevant statutes, and the need to make the requisite findings under 
the Endangered Species Act.
    An example of added complexity to a registration's risk assessment 
for an herbicide use on herbicide tolerant crops is in the case of the 
Endangered Species Act. The EPA intends to complete endangered species 
assessments for new herbicide tolerant crop uses based on the Overview 
Document-compliant method. An assessment that is Overview Document-
compliant follows the procedures and methods described in the Overview 
Document * (see www.epa.gov/sites/production/files/2014-11/documents/
ecorisk-overview.pdf). The EPA will complete these effect 
determinations as resources allow. To maximize impact within these 
limited resources, the initial registrations (e.g., Enlist Duo) are not 
nationwide in scope, and to the extent practical will focus on 
situations where EPA can make ``no effect'' decisions.
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    * Editor's note: the document referred to is retained in Committee 
file.

    Question 2. Please provide this Committee with examples of 
registration decisions, other than those related to biotechnology, 
where EPA has intentionally delayed its approval until after another 
Federal agency takes action on the crop associated with a pesticide's 
use pattern.
    Answer. While we are not aware of any other actions where the EPA's 
decision rested on another Federal agency taking action first, there 
have been circumstances where the EPA determined that consultation with 
another Federal agency would improve the decision making for a 
particular registration application. The new active ingredient decision 
for the antibiotic kasugamycin is an example of a non-biotechnology 
registration decision in which the EPA consultation with other Federal 
agencies was a contributing factor in the need to renegotiate the PRIA 
due date. To better understand the potential for bacterial resistance 
resulting from pesticidal use of the antibiotic, the EPA consulted with 
both the Centers for Disease Control and the Food and Drug 
Administration.
Questions Submitted by Hon. Dan Newhouse, a Representative in Congress 
        from Washington
    Question 1. Last year, a Federal judge in Washington State ruled 
several dairies in my district were culpable of ``open dumping'' of 
manure under the Resources Conservation and Recovery Act--commonly 
referred to as RCRA--based solely on escalated nitrate levels in nearby 
wells. This is unprecedented for a number of reasons, but primarily 
that nitrates were ruled as a ``solid waste'' under RCRA. Especially 
given that EPA's regulations under RCRA find the definition of solid 
waste, ``does not apply to agricultural wastes, including manures and 
crop residues, returned to the soil as fertilizers or soil 
conditioners.'' While there are environmental laws our nation's dairies 
are subject to--and that's a good thing--it seems clear to me that RCRA 
was not intended to be one of them. Administrator McCarthy, I would be 
interested to know if EPA has any desire or intent to revisit the 
regulations promulgated under RCRA based on this judge's misguided 
decision?
    Answer. The EPA has no current plans to develop or issue 
regulations under the resource Conservation and Recovery Act related to 
animal feeding operations.

    Question 2. In the dairy RCRA decision, the judge said of USDA's 
Natural Resource and Conservation Service (NRCS) manure lagoon 
construction standards, that, ``even assuming the [manure] lagoons were 
constructed pursuant to NRCS standards, these standards specifically 
allow for permeability and, thus, the lagoons are designed to leak.'' 
This is another reason why take such exception with this judge's 
decision, because in my experience in agriculture, I know that NRCS is 
the gold standard in technical assistance to farmers. Briefly, and 
generally, I was wondering if you could give your thoughts on NRCS and 
your Administration's relationship with them. Do you have confidence in 
NRCS standards?
    Answer. The EPA supports the goals of USDA's Natural Resources 
Conservation Service waste treatment lagoon standards providing that 
lagoons should be constructed, operated and maintained without 
polluting air or water resources; that additional measures should be 
considered to prevent a sudden breach or accidental release into 
surface water bodies, riparian areas, and critical habitat; and that 
additional measures of safety should be taken to prevent lagoon seepage 
into underlying shallow aquifers or aquifers that provide domestic 
water supplies.

    Question 3. Administrator McCarthy, as you are aware, Section 7 of 
the Endangered Species Act directs EPA to consult with Fish and 
Wildlife Services if a proposed action may impact an animal or plant 
listed as endangered. Over the past several years, EPA has been the 
target of lawsuits claiming it has failed to consult with Fish and 
Wildlife or the National Marine Fisheries Service on pesticide 
registration. In recent years, I understand your Agency has been 
working with the Services on implementing a collaborative approach, and 
is piloting that approach on a handful of active pesticide ingredients 
undergoing review. While I appreciate that EPA is now trying to meet 
its consultation requirements, I am concerned that the initial draft 
reviews for the first three active ingredients considered under this 
pilot are approximately 3,000 pages each. How do you expect this work 
to be productive or helpful to manufacturers, the farmers that use 
these products, or the species it's supposed to be protecting?
    Answer. The EPA acknowledges there is a large amount of information 
posted in support of the pilot biological evaluations (BEs) for 
chlorpyrifos, diazinon and malathion. However, the background 
information that has been made available is the basis for the EPA's 
effects determination for all threatened and endangered species and 
designated critical habitat in the United States. The main sections, 
which include the problem formulation and exposure and effects 
characterization, are approximately 250-350 pages, and the remaining 
appendices and attachments include supplemental information that 
interested parties can refer to if they wish to see the underlying data 
for our analysis.
    The EPA released the draft BEs for these three pesticides on April 
6, 2016. On May 5, 2016, the EPA, Fish and Wildlife Service (FWS), 
National Marine Fisheries Service (NMFS), and USDA held a public 
webinar for all external stakeholders to discuss the process and 
interim scientific methods used to make effects determinations for the 
three pilot chemicals, including a roadmap on how to navigate the 
various sections, appendices, and attachments of the draft BEs. There 
were 189 attendees for the webinar.
    The agencies recognize the need for further refinement of the 
interim scientific methods including an early screening step that 
effectively allows for a focus of resources on ESA-listed species and 
designated critical habitat where exposure to pesticides is likely to 
result in adverse direct and indirect effects. In addition, on June 29 
and 30, 2016, the agencies held a 2 day workshop to offer a forum for 
stakeholder suggestions for refining some of the interim scientific 
methods used in the draft BEs: 105 attended the workshop in person and 
58 more over the phone.

    Question 4. In the 2014 Farm Bill, there was a requirement 
directing the EPA, Fish and Wildlife, and National Marine Fisheries 
provide two reports updating our Committee on the progress of 
developing a workable approach on collaborative ESA consideration in 
pesticide registration. We did receive one of those reports in November 
2014, but the second one is long overdue. Do you have a sense of when 
we might expect that next report?
    Answer. The agencies are currently working on the second Report to 
Congress and expect to provide this final report by the end of 2016.

    Question 5. Administrator McCarthy, you testified at the hearing 
that EPA is working closely with the businesses and the regulated 
community on how Washington State's new water quality standards will be 
implemented. However, it was my understanding that, the regional 
administrator and regional manager for the Office and Water and 
Watersheds told a broad coalition of business and industry early in the 
process that EPA was unwilling to negotiate the fish consumption rate 
or cancer risk level. Can you tell me specifically what has EPA done to 
work with the regulated communities in Region 10 and Maine on human 
health criteria?
    Answer. The EPA has met with industry representatives (as well as 
environmentalists, Tribes, and local governments) on many occasions to 
discuss water quality standards designed to protect public health in 
the Pacific Northwest. Additionally the EPA Region 1 Regional 
Administrator held an open conference call for interested stakeholders 
to discuss Maine WQS in February 2015. In all of these discussions, the 
EPA has been clear that it is our preference that states develop water 
quality standards to protect the state's designated uses for its waters 
(e.g., fishing, swimming) using the best available science.

    Question 6. For thirty years or more, EPA, FDA, and the best 
available science have concluded that there is essentially no 
additional risk of cancer at exposures based on risk levels of 10-
\6\ as applied to the exposure of the general population (in the 
case of water quality standards a fish consumption rate) as long as the 
average consumption rate for more high exposed populations does not 
create a risk of more than 10-\4\. What scientific human 
health research has EPA developed or relied on to conclude that in 
Maine, Oregon, Idaho and Washington that high Tribal consumption rates 
must be protected to 10-\6\?
    Answer. The EPA encourages states to consider local and regional 
data when it is available in developing water quality standards that 
protect the uses of its waters such as for fishing. In many areas of 
the country, such as in Maine, Oregon, Idaho and Washington, Tribes 
have protected treaty rights that provide for reserved fishing rights. 
Additionally local and regional data show that these Tribal members 
consume much more fish. In Maine, the Wabanaki study shows rates of 
Tribal fish consumption from 286 grams per day to over 500 grams per 
day. In the northwestern states there are several fish consumption 
surveys that show that Tribal fish consumption rates over 1,000 grams 
per day. To provide for the Federal treaty rights of these Tribal 
members, the EPA expects states to consider these site-specific higher 
fish consumption rates as well as a 10-\6\ cancer risk.

    Question 7. EPA and other Federal agencies have long considered 
standards that protect within the range of risk levels of 10-
\6\ to 10-\4\ to represent a de minimis risk of 
incurring cancer. What scientific research has EPA developed or relied 
on to conclude that 10-\6\ is now an upper bound risk level 
for the protection of public health?
    Answer. The EPA considers 10-\6\ as a de minimis risk 
level but allows states to choose higher risk levels to protect their 
populations. However, treaties in Washington envision fish free from 
contaminants. To comply with these Tribal treaty rights, 10-
\6\ is a close approximation of a de minimis level of risk. The 
10-\6\ risk level is appropriate when the EPA or states take 
treaty rights into consideration when developing water quality 
standards.

    Question 8. EPA has stated numerous times over many 
Administrations--including in its 2000 Human Health Methodology--that 
there is no real difference between 10-\6\ and 10-
\5\ in terms of risk management, as long as more highly exposed 
populations are protected to 10-\4\. It is easy to 
understand why, as it is the difference between a theoretical 
additional risk of one millionth of a percent (0.000001%) and one 
hundred thousand of percent (0.00001%). Even at a risk level of 
10-\4\, the additional risk over an entire lifetime is an 
additional on ten thousandth of a percent (0.0001%). This is why 
Federal agencies, including EPA, have long considered these risk levels 
to represent the equivalent of no additional risk of additional 
cancers. If EPA applied its current and long-standing risk management 
guidance to Washington State, we would expect no new cases of cancer 
based on exposure to waters meeting the standards. Imposing more 
stringent risk management levels, reinventing a new zero, would provide 
no additional benefit to public health. What scientific research has 
EPA developed or relied on to conclude that risk levels of 10-
\6\ and 10-\5\ no longer represented essentially the 
same level of risk? What scientific research has EPA developed or 
relied on to conclude that water quality standards now require a more 
stringent application of risk levels in developing water quality 
standards?
    Answer. The EPA's use of a 10-\6\ cancer risk level is a 
risk management decision, which EPA considers appropriate for the 
general population. It is important to note that when developing the 
2000 Human Health Methodology for deriving numeric water quality 
criteria, identified in your question, we undertook a review of 
language from other agency mandates (e.g., The Clean Air Act, the Food 
Quality Protection Act) and believe the target of a 10-\6\ 
risk level is consistent with agency-wide practice. While the 
Methodology presents a range of acceptable cancer risk levels for the 
general population, states and authorized Tribes are specifically 
encouraged to consider highly exposed population groups when 
determining a protective cancer risk level including, in the case of 
the State of Washington, taking into account the important principles 
of treaty rights and environmental justice.

    Question 9. Throughout the Pacific Northwest, background 
concentrations of PCBs and Arsenic exceed the criteria EPA has proposed 
for Washington State, and the criteria that EPA has advised in comments 
should be developed by Idaho and Washington. Can EPA provide an 
analysis of impact its proposed PCB and arsenic criteria would have on 
section 303(d) listings of impaired water bodies, and what those 
listings would mean under the prohibition of new expanded discharge 
until the criteria are met? Can EPA provide an economic impact analysis 
of the impact its proposed PCB criteria will have on private and public 
facilities that hold NPDES permits and on permitted storm water 
discharges?
    Answer. The EPA evaluated the potential costs to NPDES dischargers, 
and the potential for incremental water body impairments, associated 
with state implementation of the EPA's proposed criteria. This analysis 
is contained in the record for the EPA's proposed rule for the State of 
Washington. Since the proposed rule was published, the EPA obtained 
additional water quality monitoring data from the State Department of 
Ecology's Environmental Information Management database for PCBs and 
will identify additional potential incremental impairments, if any, in 
any revised economic analysis that the EPA develops for the State of 
Washington.

    Question 10. The economic impact analysis EPA provided with its 
proposed rule in Washington State represents that there was no surface 
water data that indicated ambient concentrations of PCBs above the EPA 
proposed criteria. The Washington State Department of Ecology has 
published studies showing that all of Puget Sound and its major 
tributaries, including the Strait of Juan de Fuca, have PCB levels 
above the EPA proposed criteria. Can EPA explain why this data was not 
considered in its economic impact analysis? Has EPA identified 
treatment technologies that can achieve the proposed PCB criteria? If 
so, what does it cost to install and operate those technologies?
    Answer. Since preparing the economic analysis for the proposed 
rule, the EPA has obtained additional PCB monitoring data and will 
analyze these data and report the potential incremental impairment 
results, if any, in any revised economic analysis that the EPA develops 
for the State of Washington. Currently, the quantification limit in the 
State of Washington for PCBs is 0.1 mg/L, which is several orders of 
magnitude greater than the proposed revised criteria of 0.0000073 mg/L 
for freshwater and marine waters.

    Question 11. EPA's scientists have consistently stated that a 
Probabilistic Risk Assessment (PRA) approach represent the more 
advanced and better scientific approach to risk assessment. Why isn't 
EPA using a PRA approach to develop water quality criteria and other 
standards? Does the Agency have plans to move to that approach, 
considering its commitment to using the best science, and if so, when 
would that take place?
    Answer. The EPA is evaluating current probabilistic risk assessment 
approaches to water quality standards in the literature. As of now, no 
states have submitted human health criteria based on such an approach.
Question Submitted by Hon. Trent Kelly, a Representative in Congress 
        from Mississippi
    Question. Three years ago, a coalition of Mississippi beekeepers 
and farmers came together to identify how they could work 
collaboratively and do their part in tackling some of the bee health 
concerns. After numerous meetings and conversations this group 
ultimately concluded that agricultural pesticide exposure had little 
impact on honeybee health in Mississippi but instead factors like 
Varroa mites and the diseases they carry were much bigger issues, which 
need to be addressed. However, this coalition did acknowledge that 
communication between beekeepers and farmers would further reduce the 
risk of pesticide exposure and the group decided to launch a voluntary 
effort called the Mississippi Bee Stewardship Program. The goal of this 
program was to enhance communication and cooperation between our 
state's beekeepers and agricultural pesticide applicators. This 
stewardship program encompasses a pragmatic set of best management 
practices which deal with things like hive placement on the farm, 
identification of hive locations, and pesticide applicators being aware 
of the presence of foraging bees. A ``bee awareness'' flag was even 
designed to help people on the farm know where bees are located. This 
program has energized the agricultural industry is Mississippi and has 
created a more cooperative environment among beekeepers and farmers. 
The coalition I referred to earlier is now in the process of conducting 
assessments to determine the effectiveness of the enhanced 
communication with the hope that it has reduced and will continue to 
reduce pesticide exposure to bees.
    Last summer, the White House commissioned a Federal Task Force to 
focus on developing policy initiatives that would lead to improved 
pollinator health. Among the initiatives highlighted in the Task 
Force's report, included efforts to deal with habitat loss and 
additional research on pollinator parasites and diseases, and more 
local efforts to manage relationship between farmers and beekeepers, 
which was the interest in supporting the development of ``state managed 
pollinator protection plans.'' The Mississippi Bee Stewardship Program 
has been held up nationally as a model of the desired state management 
plan approach and our state's department of agriculture should 
commended for taking this more flexible approach that collaboration 
rather than going in a more prescriptive, one-size-fits-all, direction.
    Unfortunately, following the greater sense of good will and 
collaboration that was formed between beekeepers and farmers through 
the development of the Mississippi Bee Stewardship Program, recent 
actions by EPA in regard to key chemistries that farmers rely upon 
(Sulfoxaflor, or Tranform') and further attacks on 
imidacloprid and seed treatments are beginning to undermine those 
relationships. Growers and beekeepers in Mississippi thought that they 
had addressed their pesticide/managed pollinator issues and could see 
the path forward but now I am hearing about concerns from many of my 
farm constituents about losing or diminished access to key pesticide 
products due to EPA's interest in protecting managed honeybees.
    These products are vital to the protection against devastating 
pests that threaten farmers' crops and livelihood. The announcements 
and proposals from EPA are creating concerns in the relationships 
between farmers and beekeepers and will result in less collaboration in 
the future. It is perceived that the loss of these key crop protection 
products is the result of numerous lawsuits or environmental activists' 
claims over the process that EPA utilizes in the data collection and 
pesticide registration & review process. In addition, I am hearing from 
individual beekeepers in my state that have major concerns that if the 
farmers lose these key chemistries and are forced to sustain a major 
economic loss, they will not have a place to host their bees on the 
farms, thus creating a domino economic effect on the beekeepers as 
well.
    Recently, we were notified that farmers are beginning to tell 
beekeepers they cannot host bees on the farm in Mississippi due to 
concerns and frustrations that key products to protect their crop are 
being taken away by EPA from the threats and frivolous lawsuits filed 
by beekeepers and environmental groups. This is of great concern to me. 
In this situation, EPA's responses to claims and pressure from a 
fraction of the beekeeping industry and challenges from environmental 
groups is going to ultimately harm innocent beekeepers and find them 
with no farm to host their bees, driving wedge in the positive 
relationships that have developed over the last several years and 
impacting the beekeeper's ability to make a living.
    Many of these beekeepers are not a part of the national beekeeper 
groups and do not have their perspective represented or heard. What 
further outreach to beekeepers that host bees on farms and farmers is 
EPA planning in order to discuss these concerns?
    My office would be happy to facilitate these conversations.
    Answer. The question well describes the complex stakeholder 
dynamics, conflicting agendas, and cautions regarding both the vocal 
and silent voices that makes pollinator protection and pesticide use a 
challenging issue. The EPA also understands the concern about existing 
and new chemistries and their importance to both growers and 
beekeepers.
    The agency agrees that the Mississippi State Plan, and the work 
done in Mississippi between growers and beekeepers, is a model. Indeed, 
the Mississippi State Plan, the North Dakota State Plan, and several 
others, were the first to demonstrate that a local response to the 
issue of pollinator protection was the best way to match the needs and 
resources of the local community with this issue. That work formed the 
basis for developing the efforts around Managed Pollinator Protection 
Plans (MP3s).
    In March 2016, the EPA, in collaboration with USDA, the National 
Association of State Departments of Agriculture and the Honey Bee 
Health Coalition, held a 2 day symposium on MP3s. The Symposium was 
designed to bring together a wide range of stakeholders in order to 
share the tools, insights and relationships necessary for states, 
Tribal and other stakeholders to pursue the development of MP3 plans 
effectively and efficiently.
    Because MP3s are locally based, reflecting those that live and work 
in a state or Tribe, they serve as a forum for state and local 
stakeholders to participate. The EPA has been encouraging and 
emphasizing communication between growers and beekeepers as a key 
component of MP3s. As another component of MP3s, the EPA and USDA are 
also working with the National Integrated Pest Management (IPM) Center 
to investigate and promote commodity-based, and/or local-based best 
management practices that balance pollinator protection and crop 
production. The National IPM Center will work with State IPM 
Coordinators to identify crop/pesticide/pollinator needs and support 
them through information development and dissemination.
    Through continued work to evaluate and develop MP3s, the EPA 
intends to support the states and Tribes in identifying their needs and 
finding solutions for pollinator protection and crop production.
Questions Submitted by Hon. Suzan K. DelBene, a Representative in 
        Congress from Washington
    Question 1. Last September, the EPA published Interim 
Recommendations for environmental standards and ecolabels for use in 
Federal procurement. EPA's recommendation for lumber excludes several 
standards that are widely used in the United States, including the 
Sustainable Forestry Initiative (SFI) and American Tree Farm System 
(ATFS) standards, which represent 70% of the certified acres in the 
U.S. and 95% of the certified acres in Washington State. EPA has 
signaled that this recommendation is mandatory for Federal procurement. 
Under what circumstances may a Federal procurement officer purchase 
wood products that do not meet this FSC requirement, such as those 
certified to SFI or ATFS? And, given the significant volume of 
sustainably harvested timber that may be excluded from Federal 
purchasing, please explain the process for EPA amending this 
recommendation in the future.
    Answer. Under Executive Order 13693--Planning for Federal 
Sustainability in the Next Decade--the EPA issued recommendations to 
assist Federal purchasers in identifying and procuring environmentally 
sustainable products. The EPA's Interim Recommendation for the lumber/
wood category is based on the Department of Energy's Fiscal Year 2016 
(FY16) Priority Products List.
    As a result of stakeholder inquiries since the release of the 
Interim Recommendation, the EPA has met and is continuing to work with 
USDA and DOE's Office of Sustainable Environmental Stewardship to gain 
further information. The EPA's Standards Executive is reaching out to 
the Sustainable Forestry Initiative, the American Tree Farm System, and 
the other forestry labels that stakeholders have requested the EPA 
consider. The EPA will be in touch with these groups regarding the 
agency's review of forestry labels and their alignment with the 
National Technology Transfer and Advancement Act, the OMB Circular A-
119, and related Federal policies that guide the EPA's use of voluntary 
consensus standards and private-sector conformity assessment 
activities. In addition, the EPA continues its progress with piloting 
the Guidelines for Assessing Standards and Ecolabels for Use in Federal 
Procurement, and hopes that information gleaned from this process will 
inform thinking related to the lumber/wood category. Finally, DOE 
continues to conduct research to inform their FY16 Priority Products 
List. The EPA looks forward to reviewing all of this additional data to 
inform if and how the lumber/wood category of Interim Recommendations 
might be revised.
    The EPA has, and will continue to provide, mechanisms for public 
input as we developthese recommendations. The agency issued Federal 
Register Notices on the initial draft guidelines in 2014 and in March 
2015 for the launch of our pilot work.\11\ Those FRNs were open to 
public comment and they marked the beginning of our efforts to engage 
multi-stakeholder panels whose counsel will be considered as we move to 
finalize our recommendations. Further, any Federal acquisition 
requirements stemming from the recommendations would include a public 
comment process prior to incorporation into the Federal Acquisition 
Regulations. As such, FAR Case 20 15-033 has been developed in order to 
integrate the new requirements of E.O. 13693 into the FAR. All next 
steps related to this case, including as to when it will be available 
to the public, are viewable at http://www.acq.osd.mil/dpap/dars/
far_case_status.html.
---------------------------------------------------------------------------
    \11\ Federal Register Notice, February 27, 2014, ``Draft Guidelines 
for Product Environmental Performance Standards and Ecolabels for 
Voluntary Use in Federal Procurement'' (79 FR 11102). [See Attachment 
1] https://www.gpo.gov/fdsys/pkg/FR-2014-02-27/pdf/2014-04329.pdf.
    Federal Register Notice, March 19, 2015, ``Agency Information 
Collection Activities; Proposed Collection and Comment Request; 
Assessment of Environmental Performance Standards and Ecolabels for 
Federal Procurement'' (80 FR 14372). [See Attachment 2] https://
www.gpo.gov/fdsys/pkg/FR-2015-03-19/pdf/2015-06275.pdf.

    Question 2. What actions has the EPA taken to educate organic and 
conventional pesticide users about biopesticides?
    Answer. The EPA is committed to encouraging the development and use 
of low-risk biopesticides as alternatives to conventional chemical 
pesticides. In 1994, the EPA created the Biopesticides and Pollution 
Prevention Division (BPPD) and specifically focused it on raising the 
profile of biopesticides and helping them get licensed. BPPD, in the 
Office of Chemical Safety and Pollution Prevention--Office of Pesticide 
Programs, is responsible for regulatory activities associated with 
biologically-based pesticides, and is recognized as the international 
authority on biopesticides. In partnership with USDA and the IR-4 
Specialty/Minor Crop Project at Rutgers University, the EPA supported 
88 projects through the Biopesticide Demonstration Grant Program. From 
2004-2010, the program invested more than $1.3 million to research the 
efficacy of biopesticides for specialty and minor crops.
    The EPA is actively working with growers and grower organizations 
interested in using biopesticides. Our intent is to ensure growers have 
the information they need to incorporate biopesticides into their pest 
management programs.
    In recent years, the EPA has attended several food producer and 
marketer meetings that have included representatives of small fruit and 
vegetable growers. The EPA is establishing relationships with these 
stakeholders to provide them with information on the benefits offered 
by biopesticides.
    Additionally, the EPA is implementing a biopesticide strategy that 
includes developing case studies on biopesticide successes, especially 
instances in which biopesticides have offset conventional pesticide use 
without negatively impacting grower costs.

    Question 3. As the number of biopesticide registration actions has 
increased, has EPA directed any additional resources to the 
Biopesticide and Pollution Prevention Division? What steps has EPA made 
or is EPA planning to take to ensure biopesticide Pesticide 
Registration Improvement Act (PRIA) timeframes are met and to reduce 
the number of biopesticide renegotiations?
    Answer. In recent years, the EPA has provided additional staffing 
resources to help address the growing number of registration requests 
for biopesticides.
    Over the past 5 years, the EPA reduced the renegotiation rate from 
61.6 percent in Fiscal Year (FY) 2010 to 18 percent in FY 2015. At this 
point in FY 2016, the renegotiate rate is approximately 14.6 percent, 
which is lower than the rate for conventional pesticides. We have 
achieved these reductions through a number of measures:

   More thorough screening of applications upon submission to 
        ensure that they meet the outlined criteria for completeness at 
        the beginning of the review process;

   Identification of registration package deficiencies early in 
        the review process. This allows time for companies to fix 
        packages without having to renegotiate; and

   At industry's request, providing training seminars for 
        registrants and consultants to help ensure packages are 
        submitted correctly.
Questions Submitted by Hon. Sean Patrick Maloney, a Representative in 
        Congress from New York
    Question 1. Currently, hundreds of residents in my district lack 
access to a clean water source as a result of contaminated groundwater 
from the Hopewell Precision superfund site. Thankfully, after years of 
effort, a solution is at hand. The EPA is working with stakeholders to 
finalize the design of infrastructure that will connect the impacted 
homes to a viable water source. I appreciate the real progress that 
we've made on this issue, and want to recognize EPA Region II 
Administrator Judith Enck for her tireless work on this. Ultimately 
though, successful completion of the project will require funding from 
the EPA.
    I ask you that you fully fund this project, and do all you can to 
ensure that those impacted finally get the access to a clean water 
source. I also ask that you work with my office on this priority, and 
let me know how I can help make sure this gets done.
    Answer. The EPA anticipates the decision to fund the site should be 
made this fiscal year. While the costs of the entire cleanup of the 
Hopewell Precision Site will not be fully funded this year, it is 
anticipated that the full cost of the cleanup will be funded over 
several budget cycles which will not impact the multi-year schedule for 
completion. The first stage of work is hiring a contractor, which will 
take several months from the initiation of funding.

    Question 2. As you know, the EPA has been overseeing General 
Electric's work to remove Polychlorinated biphenyls (PCBs) from the 
Hudson River. I appreciate the significant progress that the EPA and GE 
have made in this effort in the last few years. But I am concerned that 
unless further action is taken there is a significant risk that an 
unacceptable level of PCBs could remain in the Hudson.
    In December 2015, my office helped to facilitate a meeting between 
the EPA and local stakeholders to address those concerns. I appreciate 
that the EPA took the time to meet with us. I was extremely gratified 
to see the EPA announce in the wake of the meeting its intent to 
conduct an expedited 5 year review of the Hudson River, to determine 
what further actions will be necessary.
    Can you please confirm that the EPA still plans on conducting an 
expedited 5 year review? If so, what is the anticipated timeline? I ask 
that you ensure that the review occurs in a manner that allows for a 
thorough, science-based approach. Successful completion of this review 
is vital to ensuring the long-term health of the Hudson River and its 
watershed.
    I also ask that you meet with me and local stakeholders so we can 
speak with you about this issue and share with you our thoughts on how 
we can best cooperate on the shared goal of a clean, healthy Hudson 
River.
    Answer. The second 5 year review for the site is underway and is 
being conducted in accordance with the EPA guidance. The EPA is working 
closely with all stakeholders to ensure a thorough and unbiased 5 year 
review. The stakeholders, including the Federal trustees, New York 
State Department of Environmental Conservation and Department of 
Health, and representatives of the Community Advisory Group (including 
non-governmental organizations) were invited by the EPA to participate 
on the Five Year Review team. Five Year Review team meetings are being 
held monthly through the fall.
                             [attachment 1]
Federal Register
Vol. 79, No. 39
Thursday, February 27, 2014
Notices
ENVIRONMENTAL PROTECTION AGENCY
    [EPA-HQ-OPPT-2013-0579; FRL-9906-98]

    Draft Guidelines; Product Environmental Performance Standards and 
Ecolabels for Voluntary Use in Federal Procurement; Reopening of 
Comment Period

    agency: Environmental Protection Agency (EPA).
    action: Notice; reopening of comment period.
    summary: EPA issued a notice in the Federal Register issue of 
November 27, 2013, concerning public review and comment on draft 
guidelines with a potential approach for using nongovernmental product 
environmental performance standards and ecolabels in Federal 
purchasing. This document reopens the comment period for two months, 
until April 25, 2014. The Agency received several requests to extend 
the comment period to allow more time for stakeholder review, 
collaboration, and response.
    dates: Comments, identified by docket identification (ID) number 
EPA-HQ-OPPT-2013-0579, must be received on or before April 25, 2014.
    addresses: Follow the detailed instructions as provided under 
addresses in the Federal Register document of November 27, 2013.
    for further information contact: Alison Kinn Bennett, Pollution 
Prevention Division (7409M), Office of Pollution Prevention and Toxics, 
Environmental Protection Agency, 1200 Pennsylvania Ave. NW., 
Washington, D.C. 20460-0001; telephone number: (202) 564-8859; e-mail 
address: kinn.alison@epa.gov.
    supplementary information: This document reopens the public comment 
period established in the Federal Register issue of November 27, 2013 
(78 FR 70938) (FRL-9394-7). In that document, EPA announced for public 
review and comment draft guidelines intended to provide a transparent, 
fair, and consistent approach to using nongovernmental product 
environmental performance standards and ecolabels in Federal 
purchasing, consistent with Federal standards policy and sustainable 
acquisition mandates. These draft guidelines have been developed in 
response to requests via a wide variety of stakeholder engagement 
channels from suppliers, manufacturers, environmental organizations, 
Federal purchasers, and other stakeholders over the last several years. 
EPA is hereby reopening the comment period to April 25, 2014.
    To submit comments, or access the docket, please follow the 
detailed instructions as provided under addresses in the November 27, 
2013 Federal Register document. If you have questions, consult the 
person listed under for further information contact.

    List of Subjects

    Environmental protection, Ecolabels, Government procurement, 
Guidelines, Standards.
    Dated: February 20, 2014.
    Wendy C. Hamnett, Director, Office of Pollution Prevention and 
Toxics.
    [FR Doc. 2014-04329 Filed 2-26-14; 8:45 a.m.]

    BILLING CODE 6560-50-P
                             [attachment 2]
Federal Register
Vol. 80, No. 53
Thursday, March 19, 2015
Notices
ENVIRONMENTAL PROTECTION AGENCY
    [EPA-HQ-OPPT-2014-0838; FRL-9923-58]

    Agency Information Collection Activities; Proposed Collection and 
Comment Request; Assessment of Environmental Performance Standards and 
Ecolabels for Federal Procurement

    agency: Environmental Protection Agency (EPA).
    action: Notice.
    summary: In compliance with the Paperwork Reduction Act (PRA), this 
document announces that EPA is planning to submit an Information 
Collection Request (ICR) to the Office of Management and Budget (OMB). 
The ICR, entitled: Assessment of Environmental Performance Standards 
and Ecolabels for Federal Procurement, and identified by EPA ICR No. 
2516.01 and OMB Control No. 2070--new, represents a new request. Before 
submitting the ICR to OMB for review and approval under the PRA, EPA is 
soliciting comments on specific aspects of the proposed information 
collection that is summarized in this document. The ICR and 
accompanying material are available in the docket for public review and 
comment. EPA is also announcing the testing of draft guidelines and a 
pilot project on an assessment approach for recognizing product 
environmental performance standards and ecolabels for Federal 
procurement in the following three categories: Furniture, building 
flooring, and building paints/coatings/removers. An additional purchase 
category may be piloted, depending on available resources and other 
considerations. EPA is seeking comment on the criteria/qualifications 
that will be used for the selection of the multi-stakeholder panel 
members, who will refine the draft guidelines for specific sectors. In 
addition, EPA is seeking volunteer standards development organizations 
and ecolabel programs to be assessed per the draft guidelines.
    dates: Comments on multi-stakeholder panel member criteria/
qualifications must be received on or before April 20, 2015. 
Expressions of interest to participate in the pilot and comments on the 
ICR must be received on or before May 18, 2015.
    addresses: Submit your expressions of interest to participate in 
the pilot and comments on the ICR and multi-stakeholder panel member 
criteria/qualifications, identified by docket identification (ID) 
number EPA-HQ-OPPT-2014-0838, by one of the following methods:

   Federal eRulemaking Portal: http://www.regulations.gov. 
        Follow the online instructions for submitting comments. Do not 
        submit electronically any information you consider to be 
        Confidential Business Information (CBI) or other information 
        whose disclosure is restricted by statute.

   Mail: Document Control Office (7407M), Office of Pollution 
        Prevention and Toxics (OPPT), Environmental Protection Agency, 
        1200 Pennsylvania Ave. NW., Washington, D.C. 20460-0001.

   Hand Delivery: To make special arrangements for hand 
        delivery or delivery of boxed information, please follow the 
        instructions at http://www.epa.gov/dockets/contacts.html.

    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://
www.epa.gov/dockets.
    for further information contact:

    For technical information contact: Julie Shannon, Chemistry, 
Economics, and Sustainable Strategies Division (7409M), Office of 
Pollution Prevention and Toxics, Environmental Protection Agency, 1200 
Pennsylvania Ave. NW., Washington, D.C. 20460-0001; telephone number: 
(202) 564-8834; e-mail address: shannon.julie@epa.gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill, 
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202) 
554-1404; e-mail address: TSCA-Hotline@epa.gov.
    supplementary information:

I. Testing of Updated Draft Guidelines

    In the Federal Register of November 27, 2013 (78 FR 70938) (FRL-
9394-6), EPA issued for public comment draft guidelines for product 
environmental performance standards and ecolabels for voluntary use in 
Federal procurement. EPA's goal in developing these draft guidelines is 
to create a ``transparent, fair, and consistent approach to selecting 
product environmental performance standards and ecolabels to support 
the Agency's mission and Federal sustainable acquisition mandates.'' 
The fundamental aim of the draft guidelines is to establish a cross-
sector framework to be used in recognizing non-governmental 
environmental standards (and consequently, environmentally preferable 
products meeting these standards) for use in Federal procurement.
    The draft guidelines include four sections:

  1.  Guidelines for the process for developing standards refers to the 
            procedures used to develop, maintain, and update an 
            environmental standard.

  2.  Guidelines for the environmental effectiveness of the standards 
            refers to the criteria in the environmental standard or 
            ecolabel that support the claim of environmental 
            preferability.

  3.  Guidelines for conformity assessment refers to the procedures and 
            practices by which products are assessed for conformity to 
            the requirements specified by standards and ecolabeling 
            programs.

  4.  Guidelines for Management of Ecolabeling Programs refers to the 
            organizational and management practices of an ecolabeling 
            program.

    EPA has responded to public comments and released a new version of 
the ``Guidelines for the Environmental Effectiveness of the Standards'' 
at http://www.epa.gov/draftGuidelines/responses.html. The majority of 
public comments supported EPA undertaking--with key external entity and 
stakeholder participation--additional work to further refine the draft 
guidelines and test a potential approach to assessing standards and 
ecolabels. Therefore, in this next phase of work, EPA is contracting 
with an entity to convene a coordinating Governance Committee, product 
category-specific multi-stakeholder panels, and independent assessment 
entity(ies) to develop and pilot test an approach in three product 
categories: Furniture, building flooring, and building paints/coatings/
removers. These sectors were chosen because they meet some or all of 
the following criteria:

   Potentially significant environmental and/or human health 
        impact (based on lifecycle assessments and hazard and risk 
        assessments).

   Opportunity for environmental and/or human health 
        improvement through private sector standards/ecolabels.

   Significant volume of Federal purchases.

   Current Federal sustainable acquisition mandates in the 
        category are limited, out-of-date, and/or could be augmented 
        with private sector standards.

    An additional to-be-determined purchase category may be piloted, 
depending upon available resources and other considerations. In 
addition, due to significant interest, EPA will explore the potential 
for the draft guidelines to apply to service sector standards and 
ecolabels (e.g., services related to building maintenance, cafeterias, 
and professional consultants, among others). The potential pilot for 
this sector would not assess service sector standards; rather the 
analysis and recommendations could potentially position the draft 
guidelines to accommodate such assessments in 2016 and beyond.

II. Opportunity To Participate in a Pilot

    Standards development organizations, ecolabel programs, and 
certification entities that have product environmental performance 
standards and/or ecolabels that cover one or more of the three product 
categories, and could be considered for use in Federal procurement per 
E.O. 13514, entitled: Federal Leadership in Environmental, Energy, and 
Economic Performance (74 FR 52117, October 8, 2009), the Federal 
Acquisition Regulation (FAR) (48 CFR 23.103), and Federal Government 
standards policy, should consider submitting those standards and 
ecolabels for assessment as a part of the pilot project.
    Those standards and ecolabels assessed will provide information per 
product-category specific checklists (based on the draft guidelines), 
to be developed by multi-stakeholder panels, as described at http://
www.epa.gov/epp/draftGuidelines/pilot.html. Each purchase category 
panel shall include a balanced group of relevant stakeholders in the 
environmental and human health performance standards and ecolabels 
space and ensure an objective, open, and consensus-driven process and 
credible results. The stakeholder types that may be represented on the 
multi-stakeholder panels include, but are not limited to:

   Standards development organizations.

   Ecolabel program managers/system owners.

   Conformity assessment bodies.

   Federal purchasers.

   Other large institutional purchasers such as state 
        governments or universities.

   Manufacturers and/or vendors in the product categories 
        targeted for assessment.

   Professional societies, users groups, and industry 
        consortia.

   Research and development organizations and academia.

   Non-governmental organizations widely respected for their 
        work on public health, environmental protection, and 
        sustainability issues.

   Federal Government agencies knowledgeable in conformity 
        assessment.

    EPA is seeking input from the public regarding the multi-
stakeholder panel member criteria/qualifications. EPA proposed the 
following:

   Knowledge of the environmental and/or human health impacts 
        of the particular product category.

   Experience working with diverse stakeholders towards 
        consensus.

   Familiarity with the draft Guidelines and Federal 
        sustainable acquisition mandates.

   Familiarity with standards development and conformity 
        assessment approaches.

   Ability to devote the necessary time to the panel (including 
        one meeting and regular conference calls).

   Willingness to sign a conflict of interest disclosure form.

III. Information Collection Request (ICR)

A. What comments are sought on the ICR?

    Pursuant to the PRA section 3506(c)(2)(A) (44 U.S.C. 
3506(c)(2)(A)), EPA specifically solicits comments and information to 
enable it to:

  1.  Evaluate whether the proposed collection of information is 
            necessary for the proper performance of the functions of 
            the Agency, including whether the information will have 
            practical utility.

  2.  Evaluate the accuracy of the Agency's estimates of the burden of 
            the proposed collection of information, including the 
            validity of the methodology and assumptions used.

  3.  Enhance the quality, utility, and clarity of the information to 
            be collected.

  4.  Minimize the burden of the collection of information on those who 
            are to respond, including through the use of appropriate 
            automated electronic, mechanical, or other technological 
            collection techniques or other forms of information 
            technology, e.g., permitting electronic submission of 
            responses.

    In particular, EPA is requesting comments from very small 
businesses and nonprofit organizations (those that employ less than 25) 
on examples of specific additional efforts that EPA could make to 
reduce the paperwork burden for very small businesses and nonprofit 
organizations affected by this collection.

B. What information collection activity or ICR does this apply to?

    Title: Assessment of Environmental Performance Standards and 
Ecolabels for Federal Procurement.
    ICR number: EPA ICR No. 2516.01.
    OMB control number: OMB Control No. 2070--New.
    ICR status: This ICR is for a new information collection activity. 
An Agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information, unless it displays a currently 
valid OMB control number. The OMB control numbers for EPA's regulations 
in title 40 of the Code of Federal Regulations (CFR), after appearing 
in the Federal Register when approved, are listed in 40 CFR part 9, are 
displayed either by publication in the Federal Register or by other 
appropriate means, such as on the related collection instrument or 
form, if applicable. The display of OMB control numbers for certain EPA 
regulations is consolidated in 40 CFR part 9.
    Abstract: EPA is engaging in this collection pursuant to the 
authority in the Pollution Prevention Act (42 U.S.C. 13103(b)(11)), 
which requires EPA to ``Identify opportunities to use Federal 
procurement to encourage source reduction'' and section 12(d) of the 
National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272 
note), which requires Federal agencies to ``use technical standards 
that are developed or adopted by voluntary consensus standards bodies, 
using such technical standards as a means to carry out policy 
objectives or activities.'' Federal agencies need this assessment per 
the draft guidelines to determine which, among sometimes dozens of 
private sector standards within a single purchase category, are 
appropriate and effective in meeting Federal procurement goals and 
mandates.
    Federal agencies must comply with the following sustainability-
related purchasing mandates: Section 2(h) of E.O. 13514; section 6002 
of the Resource Conservation and Recovery Act (42 U.S.C. 6002); section 
9002 of the Farm Security and Rural Investment Act (7 U.S.C. 8102); the 
Energy Policy Act (42 U.S.C. 13201 et seq.); section 2(d) of E.O. 
13423, entitled: Strengthening Federal Environmental, Energy, and 
Transportation Management (72 FR 3919, January 26, 2007); and the FAR, 
including 48 CFR part 23, entitled: Environment, Energy and Water 
Efficiency, Renewable Energy Technologies, Occupational Safety, and 
Drug-Free Workplace (see http://www.whitehouse.gov/omb/
procurement_index_green).
    Via NTTAA, Federal agencies are required to ``use technical 
standards that are developed or adopted by voluntary consensus 
standards bodies, using such technical standards as a means to carry 
out policy objectives or activities,'' except when an agency determines 
that such use ``is inconsistent with applicable law or otherwise 
impractical.'' OMB Circular A-119, entitled: Federal Participation in 
the Development and Use of Voluntary Consensus Standards and in 
Conformity Assessment Activities, reaffirms Federal agency use of non-
governmental standards in procurement.
    While Federal purchasing policy is clear for the several standards 
and ecolabels that are listed in statute, regulation, or Executive 
Order, the lack of independently assessed information about and Federal 
guidance on using other product environmental performance standards and 
ecolabels often results in an inconsistent approach by Federal 
purchasers and confusion and uncertainty for vendors and manufacturers.
    Burden statement: The annual public reporting and record-keeping 
burden for this collection of information is estimated to average 8.5 
hours per response. Burden is defined in 5 CFR 1320.3(b).
    The ICR, which is available in the docket along with other related 
materials, provides a detailed explanation of the collection activities 
and the burden estimate that is only briefly summarized here:
    Respondents/Affected Entities: Entities potentially affected by 
this ICR are standards development organizations, ecolabeling programs, 
and environmental certification entities.
    Estimated total number of potential respondents: 20.
    Frequency of response: Once during 2015 pilot; and, a to-be-
determined frequency depending upon learnings from the pilot.
    Estimated total average number of responses for each respondent: 2.
    Estimated total annual burden hours: 340 hours.
    Estimated total annual costs: $24,711.20 for burden hours, and $0 
estimated costs for capital investment or maintenance and operational 
costs.

C. What is the next step in the process for this ICR?

    EPA will consider the comments received and amend the ICR as 
appropriate. The final ICR package will then be submitted to OMB for 
review and approval pursuant to 5 CFR 1320.12. EPA will issue another 
Federal Register document pursuant to 5 CFR 1320.5(a)(1)(iv) to 
announce the submission of the ICR to OMB and the opportunity to submit 
additional comments to OMB. If you have any questions about this ICR or 
the approval process, please contact the technical person listed under 
for further information contact.
    Authority: 44 U.S.C. 3501 et seq.
    Dated: March 11, 2015.
    James Jones, Assistant Administrator, Office of Chemical Safety and 
Pollution Prevention.
    [FR Doc. 2015-06275 Filed 3-18-15; 8:45 a.m.]

    BILLING CODE 6560-50-P
                             [attachment 3]
    [https://www.epa.gov/pesticide-reevaluation/registration-review-
schedules]
Registration Review Schedules
    Through the Pesticide Registration Review program (https://
www.epa.gov/pesticide-reevaluation/registration-review-process), EPA 
reviews all registered pesticides at least every 15 years, as mandated 
by the Federal Insecticide, Fungicide, and Rodenticide Act.
    EPA always strives to base its decisions on the best available 
sound science. However, science is constantly evolving, and new 
scientific information can come to light at any time and change our 
understanding of potential risks from pesticides. The review of new 
data could potentially prolong the risk assessment and decision-making 
process and change this schedule.
    Below is a schedule of the status of different pesticides 
undergoing the registration review process. This schedule is subject to 
change based on shifting priorities and is intended to be a rough 
timeline. The schedule will be updated regularly to reflect any 
timeline changes, and to include anticipated deliverables for later 
dates.
Explanation of List
    The registration review process (https://www.epa.gov/pesticide-
reevaluation/registration-review-process#process%20components) 
includes:

   Docket Openings (https://www.epa.gov/pesticide-reevaluation/
        registration-review-docket-opening-schedule).

   Draft Risk Assessments (https://www.epa.gov/pesticide-
        reevaluation/registration-review-process#case%20development).

   Proposed Interim Decisions/Proposed Decisions (https://
        www.epa.gov/pesticide-reevaluation/registration-review-
        process#decision).

   Interim Decisions/Decisions (https://www.epa.gov/pesticide-
        reevaluation/registration-review-process#decision).

    EPA commits to an open and transparent process by accepting public 
comments at most stages of the process. These are collected in each 
chemical's docket at www.regulations.gov and all comments submitted 
will be accounted for in the Agency's regulatory decisions for each 
chemical.
    The schedule is also categorized by the fiscal year's (FY) 
quarters. Please note the following timeframes:

   Quarter 1 (Q1): October-December

   Quarter 2 (Q2): January-March

   Quarter 3 (Q3): April-June

   Quarter 4 (Q4): July-September
Registration Review Schedules
Draft Risk Assessments
FY16 Quarter 3
   2,4-D salts and esters

   Atrazine

   Carfentrazone-ethyl

   Chlorethoxyfos

   Copper salts

   Cymoxanil

   Diazinon

   Kresoxim-Methyl

   Linuron

   Malathion

   Mineral Acids

   Propazine

   Simazine

   Spinosad/Spinetoram
FY16 Quarter 4
   Acephate

   Cyclanilide

   Cyprodinil

   Dimethomorph

   Etofenprox

   Fenpropathrin

   Flumethrin

   Glycolic acid and salts

   Imiprothrin

   Mepiquat chloride

   Metalaxyl/mefenoxam

   MGK-264

   Momfluorothrin

   Oxytetracycline

   Phenothrin (Sumithrin)

   Phosmet

   Prallethrin

   Pyrethrins

   Tau-fluvalinate

   Tefluthrin

   Tetramethrin
Proposed Interim Decisions/Interim Decisions
FY16 Quarter 3
   Antimycin-A

   Clethodim

   Flufenacet

   Flurprimidol

   Fosamine ammonium

   Glufosinate

   Lithium hypochlorite

   Methoxyfenozide

   Sucrose octanoate

   Sulfonylurea (SU) herbicides

     Bensulfuron-methyl

     Chlorimuron-ethyl

     Chlorsulfuron

     Flazasulfuron

     Foramsulfuron

     Halosulfuron-methyl

     Imazosulfuron

     Iodosulfuron-methyl-Na

     Mesosulfuron-methyl

     Metsulfuron-methyl

     Nicosulfuron

     Orthosulfamuron

     Primisulfuron-methyl

     Prosulfuron

     Rimsulfuron

     Sulfometuron-methyl

     Sulfosulfuron

     Thifensulfuron-methyl

     Triasulfuron

     Tribenuron-methyl

     Trifloxysulfuron-Na

     Triflusulfuron-methyl

   Tebufenozide
FY16 Quarter 4
   Azoxystrobin

   Boric Acid

   Diquat Dibromide

   Ethephon

   Hexazinone

   Hymexazol
Interim Decisions/Decisions
FY16 Quarter 3
   Alpha-chlorohydrin

   Chlorfenapyr

   Cyanamide
FY16 Quarter 4

   2-(Decylthio)ethanamine hydrochloride (DTEA-HCl)

   Aliphatic alcohols, C1-C5

   Bentazon

   Propoxur

   Propoxycarbazone

   Sodium Acifluorofen

   Thidiazuron

    Contact Us (https://www.epa.gov/pesticide-reevaluation/forms/
contact-us-about-pesticide-reevaluation) to ask a question, provide 
feedback, or report a problem.

          [Accessed September 8, 2016]
                             [attachment 4]
    [https://www.epa.gov/pesticide-registration/understanding-science-
behind-epas-pesticide-decisions]
Understanding the Science behind EPA's Pesticide Decisions
    Science is the backbone of the EPA's decision-making. The Agency's 
ability to pursue its mission to protect human health and the 
environment depends upon the integrity and quality of the science on 
which it relies. The environmental policies, decisions, guidance, and 
regulations that impact the lives of all Americans must be grounded, at 
a most fundamental level, in sound, high quality science.
    The EPA regulates pesticides to ensure that they do not pose 
unreasonable risks to human health or the environment. As part of that 
effort, the EPA requires extensive test data from pesticide producers 
that demonstrate pesticide products can be used without causing harm to 
human health and the environment.
    We evaluate information from all kinds of sources--pesticide 
companies, other governments, academia, and the published scientific 
literature. EPA scientists and analysts carefully review these data to 
determine whether to register (license) a pesticide product or use and 
whether specific restrictions are necessary. EPA maintains a 
transparent, public process for assessing potential risks to human 
health when evaluating pesticide products.
    On this page:

   Risk Assessment Process

     Ecological Risk Assessment

     Human Health Risk Assessment

     Epidemiology Studies

   When EPA Receives New Studies

   Scientific Integrity and Transparency
Risk Assessment Process
    The process EPA uses for evaluating the potential for health and 
ecological effects of a pesticide is referred to as a risk assessment. 
The risk assessment is crucial to the overall decision-making process 
for pesticides, both new and existing. New pesticides must be evaluated 
before they can enter the market. Existing pesticides must be re-
evaluated periodically to ensure that they continue to meet the 
appropriate safety standard. EPA's decision-making relies on a risk 
management process, which is conducted in registration for new 
pesticide chemicals (https://www.epa.gov/pesticide-registration) or new 
uses of existing chemicals, or reregistration or registration review in 
the case of a general review of an existing chemical (https://
www.epa.gov/pesticide-reevaluation).
    There are two main components to the risk assessment:

   Ecological Risk Assessment

   Human Health Risk Assessment
Ecological Risk Assessment
    EPA conducts ecological risk assessments to determine what risks 
are posed by a pesticide and whether changes to the use or proposed use 
are necessary to protect the environment. Many plant and wildlife 
species can be found near or in cities, agricultural fields, and 
recreational areas. Before allowing a pesticide product to be sold on 
the market, the EPA ensures that the pesticide will not pose any 
unreasonable risks to plants, wildlife, and the environment. This is 
done by evaluating data submitted in support of registration regarding 
the potential hazard that a pesticide may present to non-target plants, 
fish, and wildlife species. In addition, EPA reviews scientific studies 
available in the open literature.
    Ecological risk assessments include three phases, and are generally 
conducted following the Guidelines for Ecological Risk Assessment 
(https://www.epa.gov/osa/basic-information-about-risk-assessment-
guidelines-development).
Human Health Risk Assessment
    A human health risk assessment process estimates the nature and 
probability of adverse health effects in people who may be exposed to 
chemicals in the food and water they consume or in the air they 
breathe; through their work; or as a result of activities that may lead 
to contact with pesticide residues on treated surfaces now or in the 
future.
    EPA uses the National Research Council's process for human health 
risk assessments:

  1.  Hazard Identification: Examines whether a pesticide has the 
            potential to cause harm to humans and/or ecological 
            systems, and if so, under what circumstances.

  2.  Dose Response Assessment: Examines the numerical relationship 
            between exposure and effects.

  3.  Exposure Assessment: Examines what is known about the frequency, 
            timing, and levels of contact with a pesticide.

  4.  Risk Characterization: Examines how well the data support 
            conclusions about the nature and extent of the risk from 
            exposure to pesticides.
Epidemiology Studies
    EPA considers epidemiology studies that are available as part of 
its human health risk assessment data and actively supports the 
Agricultural Health Study (https://aghealth.nih.gov/). EPA reviews the 
available epidemiological information using a peer reviewed framework 
with well-accepted evaluation factors that specifically consider links 
between pesticide exposure and health outcomes.

   Epidemiology Framework: EPA developed a framework to 
        incorporate epidemiology into risk assessment as one component 
        of our work in this area. Concepts in the framework are based 
        on peer-reviewed, robust principles and tools, and incorporate 
        improvements based on recommendations from the National 
        Academies' National Research Council reports on Toxicity 
        Testing in the 21st Century (http://www.nap.edu/catalog/11970/
        toxicity-testing-in-the-21st-century-a-vision-and-a) and 
        Advancing Risk Assessment (http://www.nap.edu/catalog/12209/
        science-and-decisions-advancing-risk-assessment). This 
        methodology was reviewed in 2010 by the Federal Insecticide, 
        Fungicide, and Rodenticide Act (FIFRA) Scientific Advisory 
        Panel (SAP) (https://www.epa.gov/sap), an advisory panel of 
        outside experts.

    EPA is beginning to implement systematic review procedures 
consistent with the recommendations of EPA's Integrated Risk 
Information System (IRIS) (https://www.epa.gov/iris) workshops, the 
National Toxicology Program (http://ehp.niehs.nih.gov/1306711/), and 
others. As this process proceeds, the EPA anticipates improved 
transparency of how scientific information across a broad spectrum of 
scientific disciplines are integrated into our risk assessment and 
decision-making process.
When EPA Receives New Studies
    EPA actively seeks out and considers new studies, and accounts for 
this information in pesticide regulatory decisions. When compelling 
data make it clear that regulatory action must be taken, the Agency 
responds appropriately.
    We look closely at every study to determine whether the results are 
scientifically sound. Our analysis gives greater weight to high quality 
and well documented studies and those findings confirmed by multiple 
sources. Ultimately, the Agency looks at all of the studies to decide 
what the preponderance of evidence shows.
    EPA has practices in place and enforcement policies to help ensure 
that studies represent sound science. Once studies are submitted to the 
Agency, EPA scientists conduct extensive analysis of the data to ensure 
that the design of the study is appropriate and that the data are 
collected and analyzed accurately.
    EPA uses its peer-reviewed framework (https://www.epa.gov/
pesticide-registration/understanding-science-behind-epas-pesticide-
decisions#framework) to incorporate additional epidemiological studies 
into the risk assessment. Additional information on the risk assessment 
process for pesticides (https://www.epa.gov/pesticide-science-and-
assessing-pesticide-risks/overview-risk-assessment-pesticide-program).
    EPA guidance on the review of open literature (https://www.epa.gov/
pesticide-science-and-assessing-pesticide-risks/guidance-identifying-
selecting-and-evaluating-open).
Transparency and Scientific Integrity
    At the EPA, scientific integrity is closely linked to transparency. 
The Agency remains committed to transparency in its interactions with 
all members of the public and has released Agency-wide principles and 
policies to clarify the importance of scientific integrity:

   EPA's Scientific Integrity Policy February 2012 (https://
        www.epa.gov/risk/policy-epa-scientific-integrity) builds on the 
        EPA's long history of scientific safeguards and further ensures 
        that sound science drives Agency decision making.

   EPA's Principles of Scientific Integrity (https://
        www.epa.gov/osa/epas-principles-scientific-integrity-fact-
        sheet) outlines foundational principles that promote a culture 
        of scientific integrity, public involvement, the use of peer 
        review and Federal Advisory Committees, and the development of 
        Agency scientists. It also establishes a Scientific Integrity 
        Committee to implement the Agency-wide Scientific Integrity 
        policy.

   Annual Report on Scientific Integrity: The 2014 Annual 
        Report (https://www.epa.gov/osa/2014-annual-report-scientific-
        integrity) highlights EPA's scientific integrity successes.

    Additional information on EPA's Scientific Integrity Policies 
(https://www.epa.gov/osa/basic-information-about-scientific-integrity).
    Learn about EPA and the Open Government Initiative (https://
www.epa.gov/open).
    Contact Us (https://www.epa.gov/pesticide-registration/forms/
contact-us-about-pesticide-registration) to ask a question, provide 
feedback, or report a problem.

          [Accessed September 8, 2016]
                             [attachment 5]
Excerpt of Revised Chlorpyrifos Human Health Risk Assessment
Appendix 6. Columbia Center for Children's Environmental Health (CCCEH) 
        Epidemiology Data Acquisition ``Raw Data'' Request
I. Action Requested
    To fulfill identified information needs for the purposes of 
incorporating the Columbia Center for Children's Environmental Health 
(CCCEH) epidemiology data into the Human Health Risk Assessment (HHRA) 
for chlorpyrifos, the agency sought to obtain certain ``raw data'' from 
CCCEH researchers. Specifically, EPA requested the original analytic 
data file used to support analyses presented in the peer-reviewed, 
published epidemiology studies concerning in utero chlorpyrifos 
exposure (V. Rauh, et al., 2011; V.A. Rauh, et al., 2006; Whyatt, et 
al., 2004). CCCEH researchers did not agree to provide these data, 
however, the researchers met with EPA and discussed the agency's 
questions about the data to help determine whether further review of 
the raw data might assist EPA in resolving uncertainties. As a result 
of new information gathered through an on-site meeting and other 
sources, EPA is no longer pursuing the request for the original 
analytic data file from CCCEH researchers. This memorandum details the 
new information gained that resolves or renders unobtainable the 
previously identified information needs.
II. Background
    EPA considers many different types of scientific information when 
performing a human health risk assessment (HHRA) of pesticide exposure 
in the human population. Traditionally, EPA uses toxicology, product 
and residue chemistry, and industrial hygiene studies as well as 
measured and modeled human and environmental exposure information to 
support assessment of environmental risks. In its preparation of the 
HHRA for chlorpyrifos, the agency has evaluated environmental 
epidemiology studies of the potential risk of long-term 
neurodevelopmental effects such as delayed motor skill acquisition or 
reduced intelligence quotient (IQ) measures among children who 
experienced pesticide exposure during gestational development. There 
are three prospective birth cohort studies in the U.S. that examine 
pesticide exposure (as well as other environmental toxicants) to the 
pregnant mother and fetus, and then measure neurological and 
neurodevelopmental performance in children as they grow older. EPA has 
provided some of the funding support for each of these studies. Authors 
hypothesize that in utero and early life exposure may influence brain 
development and effect neurological functioning in children. These 
studies include the CHAMACOS study in the Salinas Valley, CA, the Mt. 
Sinai children's environmental health study (Mt. Sinai study), and the 
Columbia Center for Children's Environmental Health (CCCEH).
    The CCCEH study is the only one of the three studies that measures 
maternal and fetal exposure to chlorpyrifos specifically; the other two 
cohorts measure exposure to organophosphate pesticides generally. 
Authors with the CCCEH study reported reduced birth weight and birth 
length among neonates more highly exposed to chlorpyrifos during 
gestation (as measured by cord blood concentration of chlorpyrifos) 
(Whyatt, et al., 2004). Similarly, authors observed slower motor skill 
acquisition and reduced mental capacity among infants who were more 
highly exposed to the chemical in utero (V.A. Rauh, et al., 2006). In 
2011, authors from all three birth cohort studies concurrently reported 
evidence of reduced measures of intelligence (Wechslar intelligence 
scale scores) by increasing in utero chlorpyrifos and/or 
organophosphate exposure (M.F. Bouchard, et al., 2011; Engel, et al., 
2011; V. Rauh, et al., 2011).
    Given the value of this information to the agency's HHRA for 
chlorpyrifos, EPA requested the FIFRA SAP to provide external peer 
review of the strengths and limitations of the epidemiology data for 
use in the chlorpyrifos HHRA (FIFRA SAP September 2008 and April 2012). 
The agency identified two major areas in which additional information 
was needed to fully incorporate these data into the HHRA: additional 
measures of environmental exposure to chlorpyrifos in the CCCEH cohort 
to discern whether acetyl cholinesterase inhibition was likely to have 
occurred in connection with reported adverse outcomes, and also the 
role of other environmental chemicals (lead, polycyclic aromatic 
hydrocarbon (PAH), other organophosphate pesticides) in the observed 
adverse neurological effects reported in relation to in utero 
chlorpyrifos exposure.
    To fulfill these information needs for the purposes of 
incorporating the epidemiology data into the chlorpyrifos HHRA, the 
agency sought to obtain certain ``raw data'' from the Columbia Center 
for Children's Environmental Health (CCCEH) study. Specifically, EPA 
requested the original analytic data file used to support analyses 
presented in the peer-reviewed, published epidemiology studies 
concerning in utero chlorpyrifos exposure (V. Rauh, et al., 2011; V.A. 
Rauh, et al., 2006; Whyatt, et al., 2004). CCCEH did not agree to 
provide the data based upon these initial inquiries and they asserted 
that because EPA did not fund the pesticide exposure component of their 
cohort study EPA was not legally entitled to review their underlying 
data. CCCEH did agree, however, to meet and discuss EPA's questions 
about the data to help determine whether further review of the raw data 
might assist EPA in resolving uncertainties. As a result on April 15, 
2013, EPA scientists and CCCEH researchers held an all-day meeting at 
the CCCEH data center (Mailman School of Public Health, New York City, 
NY) to discuss EPA's information needs and whether acquisition of the 
full analytic data would be necessary or valuable to EPA's assessment. 
Addendum 1 delineates the questions EPA posed to CCCEH study staff at 
this all-day meeting.
III. Resolution of Information Needs
A. Epidemiology Study Exposure Characterization
    The primary rationale supporting EPA's request for ``raw data'' 
from the CCCEH researchers relates to the agency's need to determine 
whether the levels of chlorpyrifos exposure in the environment 
(apartments, apartment building or other outdoor environment, or 
dietary exposure) of CCCEH study participants were above or below 
levels that may elicit a greater than 10% inhibition of 
acetylcholinesterase enzyme levels, the current regulatory endpoint. 
During the April 2013 meeting, EPA learned that this type of 
information is neither available nor obtainable. CCCEH researchers 
estimated relative pesticide exposure using several different exposure 
methods including 48-hour air sampling with personal monitor, 2-week 
integrated stationary air monitoring, maternal urinary concentration of 
TCPy (urinary metabolite of chlopryrifos) during the last trimester of 
pregnancy, maternal urinary concentration of TCPy at delivery, and 
umbilical cord blood and meconium at delivery. To determine whether a 
significant change in acetyl cholinesterase levels may have occurred as 
a result of actual environmental exposure, temporal concordance between 
pesticide use and the chlorpyrifos measurement is needed, i.e., 
exposure estimation at the time of pesticide application is optimal. 
The CCCEH study design did not incorporate pre- and post-pesticide use/
exposure measurement in the study protocol. Therefore, this information 
was not collected and is not retrospectively obtainable.
    In addition, EPA requested any additional information obtained by 
researchers as to specific pesticide products used to better understand 
the pattern and frequency of organophosphate pesticide use among cohort 
participants. This information was solicited from participants in a 
written questionnaire administered during a follow-up period 
(unpublished copy of questionnaire obtained by EPA Oct. 2012). In 
response to the EPA inquiry, researchers recalled that the Whyatt 
(2002) publication described the challenges of collecting pesticide 
product information in etiologic epidemiology studies, and in the on-
site meeting in April 2013 confirmed that the information quality in 
the CCCEH written questionnaire responses is very low. This information 
was deemed of such poor quality by CCCEH data analysts that the data 
were not coded or entered into the analytic data file. Therefore, EPA 
learned that this specific request for ``raw data'' concerning 
pesticide product use is not available.
    As a surrogate for this information, CCCEH researchers suggested 
EPA contact the New York City Department of Health to obtain a linked 
dataset of CCCEH study participant residential address and public 
housing pesticide usage. The linked dataset provides aggregated 
pesticide usage data at the cohort participant building-level only. EPA 
has obtained and reviewed these data (June 2013) and determined that 
pursuing a data reconstruction exercise is the most appropriate way to 
estimate environmental pesticide exposure that would have to occur 
among CCCEH study participants. EPA has conducted such analysis and 
included it in the revised human health risk assessment.
B. Co-Exposure to Other Environmental Contamin[a]nts
    A second major concern raised by EPA, FIFRA SAP peer reviewers, and 
public commenters is the ability of the CCCEH study authors to 
accurately measure and statistically model the relationship between 
other environmental chemicals (lead and PAH, specifically) or other 
pesticides (diazinon, propoxur) that may influence fetal brain 
development and childhood neurodevelopmental performance, and also be 
related to chlorpyrifos exposure (these are ``potentially confounding'' 
exposures). EPA's concern stems from the understanding that if these 
other exposures are not sufficiently considered in the epidemiological 
analysis, then an incorrect inference and conclusion may result (i.e., 
a potential false positive association). For example, prenatal and 
early life exposure to lead in the environment has been causally linked 
to adverse neurodevelopmental outcomes similar to those measured in the 
CCCEH cohort study including intelligence measures. EPA was concerned 
about the potential error in the CCCEH study if lead levels were not 
appropriately considered, i.e., the apparent chlorpyrifos effect on 
neurodevelopment observed in the study may have been due to the lead 
exposure.
    However, EPA has confirmed with study authors that lead levels and 
chlorpyrifos levels in cord blood are not statistically associated in 
this population. Plotting blood lead levels against cord blood 
chlorpyrifos levels illustrates that the two exposures are extremely 
weakly (linearly) correlated in this cohort (r<1%) (V.A. Rauh, et al., 
2006). Further, EPA learned from unpublished, supplemental analyses 
performed by CCCEH researchers upon EPA request that postnatal blood 
lead levels and prenatal chlorpyrifos levels are also not strongly 
statistically associated (Andrews, January 21, 2013). This is plausible 
because of intensive lead abatement programs on-going in New York City 
during the time period of this study. According to the New York City 
Department of Health, the number of children with elevated blood lead 
levels declined 92% between 1995 and 2008.\75\ Therefore, because the 
two exposures are not related, it is not likely that pre- or postnatal 
blood lead exposure could explain the observed association with 
chlorpyrifos.
---------------------------------------------------------------------------
    \75\ http://www.nyc.gov/html/doh/html/data/stats-childlead.shtml.
---------------------------------------------------------------------------
    Furthermore, during the April 2013 meeting CCCEH researchers 
pointed out that based upon available information it appears that lead 
and chlorpyrifos may affect the brain differently. It is well 
understood that lead affects the neurodevelopmental sub-domain leading 
to outward motivation and aggression; while research within the CCCEH 
cohort indicates chlorpyrifos may affect inward motivation, information 
processing and organization (V. Rauh, et al., 2011; V.A. Rauh, et al., 
2006; Wright, et al., 2008). Additionally, MRI imaging studies of lead 
affected persons and preliminary brain imaging studies of chlorpyrifos 
affected persons show different MRI patterns, grey matter as opposed to 
white matter compositional patterns, respectively (Brubaker, Dietrich, 
Lanphear, & Cecil, 2010; Brubaker, et al., 2009; Cecil, et al., 2008; 
Cecil, et al., 2011; V.A. Rauh, et al., 2012). Therefore, given that 
neither pre- nor postnatal lead levels and chlorpyrifos levels are not 
statistically associated with one another in the CCCEH study, and the 
different ways through which lead and chlorpyrifos appear to influence 
neurodevelopmental domains EPA concludes that lead exposure did not 
likely confound (bias or render incorrect) the observed association 
between chlorpyrifos exposure and neurodevelopment in this study 
population.
    Peer review panelists participating on the April 2012 FIFRA SAP 
panel identified the concern that authors had not fully considered the 
long-term effects of polycyclic aromatic hydrocarbon (PAH) exposure, a 
ubiquitous air pollutant in inner-city areas such as NYC, in the 
observed association between chlorpyrifos and neurodevelopmental 
outcomes. Specifically, panelist argued that `a shift in environmental 
exposures over time' such that postnatal PAH exposure may have combined 
with the measured in utero pesticide exposure to result in the observed 
ND outcomes. During the April 2013 meeting, authors clarified that the 
study design did not include a repeat measure of exposures over time, 
so an analysis of postnatal PAH exposures is not possible. In the 
published studies, authors were able to control for the effect of 
prenatal PAH through statistical adjustment. In addition, authors 
examined the possible modifying role of prenatal PAH in this 
epidemiological association and did not observe any evidence of a 
different risk estimate between chlorpyrifos and ND among those more 
highly exposed to PAH. Concerning the role of postnatal environmental 
exposures, CCCEH researchers also stated their belief that their 
overall study results illustrate that it is gestational exposure, and 
not early life exposure, that influences neurodevelopment in the study 
population. They state that the longitudinal analyses of infant and 
child neurodevelopment in relation to in utero chlorpyrifos exposure 
illustrates a persistent effect of the prenatal environment (M. 
Bouchard, et al., 2003; M.F. Bouchard, et al., 2011; Engel, et al., 
2007; Engel, et al., 2011; Eskenazi, et al., 2004; Eskenazi, et al., 
2007; V. Rauh, et al., 2011; V.A. Rauh, et al., 2006; Whyatt, et al., 
2004). EPA concluded that CCCEH researchers utilized best practices in 
statistical analysis of epidemiological data concerning the role of 
prenatal PAH in neurodevelopmental outcomes, and that a study of 
repeated, postnatal PAH exposure was beyond the scope of the current 
CCCEH study, and would require a follow-up study not yet undertaken.
    EPA was also interested to learn more about the co-exposure to 
other organophosphate pesticides among CCCEH study participants. 
Specifically, EPA as well as external peer review panelists noted the 
uncertainty as to the degree to which exposure to multiple acetyl 
cholinesterase inhibiting pesticides exposures over time and/or 
concurrent in time may have influenced study results. CCCEH researchers 
agreed that a more clear understanding of the role of mixtures--
exposure to multiple OP pesticides overall or concurrent in time--on 
these neurodevelopmental outcomes is desirable; however they also 
recognized that the current sample size is too small to perform this 
type of analysis. To better understand the role of exposure to a 
mixture of OP pesticides a new cohort study with a larger sample size 
and different design is required. Therefore, EPA concluded that co-
exposure to multiple organophosphate mixtures is not currently 
obtainable.
    For risk characterization purposes, EPA was also interested in 
understanding the relative contributions of various environmental 
exposures on ND outcomes, (e.g., PAH, environmental tobacco smoke, 
chlorpyrifos). Researchers noted that a preliminary indication of the 
relative contribution of various risk factors for intelligence measures 
in these cohorts can be seen through examination of supplemental tables 
published by CCCEH researchers, i.e., the beta-coefficients provided in 
published supplemental tables provide an indication of the relative 
contribution of each risk factor (V. Rauh, et al., 2011). However, 
CCCEH researchers indicated that to gain a true reflection the causal 
model in the population a series of studies in other study populations 
is needed. EPA and CCCEH researchers agreed that these studies will 
likely accumulate over time, however they are not currently available.
IV. Conclusions
    In the past, EPA sought to obtain the original analytic data file 
used to support certain epidemiological analysis of in utero exposure 
to chlorpyrifos and subsequent adverse neurodevelopmental health 
outcomes in children generated by the Columbia Center for Children's 
Environmental Health (CCCEH) to support the Human Health Risk 
Assessment (HHRA) of chlorpyrifos. EPA believed these data were 
important to both clarify the exposure-response relationship observed 
in the epidemiology study relative to the current regulatory endpoint 
(acetylcholinesterase inhibition), and also to resolve uncertainties 
regarding study participants co-exposure to other environmental 
contaminants, among other areas of uncertainties. CCCEH researchers did 
not agree to provide these data, however, the researchers met with EPA 
and discussed the agency's questions about the data to help determine 
whether further review of the raw data might assist EPA in resolving 
uncertainties. As a result of this meeting and additional discussions 
with CCCEH staff, EPA concluded that access to the raw data would 
either not provide answers to EPA's questions or that the information 
EPA sought could be obtained without analyzing the raw data. Indeed, 
based on discussions in that meeting as well as further work conducted 
by agency staff, EPA has gained additional information to better 
clarify and characterize the major issue areas identified as 
uncertainties. For these reasons, EPA decided that it would not further 
pursue its request for the analytic data file from the CCCEH 
researchers.

                               Works Cited
 
 
 
    Andrews, H.F. (January 21, 2013). [Clarification of Relation between
 Blood Lead and Cord Blood Levels of Chlorpyrifos in the Columbia Center
 for Children's Environmental Health (CCCEH) Studies (Electronic mail
 communication)].
    Bouchard, M., Gosselin, N.H., Brunet, R.C., Samuel, O., Dumoulin,
 M.J., & Carrier, G. (2003). Atoxicokinetic model of malathion and its
 metabolites as a tool to assess human exposure and riskthrough
 measurements of urinary biomarkers. Toxicol. Sci., 73(1), 182-194. doi:
 10.1093/toxsci/kfg061.
    Bouchard, M.F., Chevrier, J., Harley, K.G., Kogut, K., Vedar, M.,
 Calderon, N., . . . Eskenazi, B. (2011). Prenatal exposure to
 organophosphate pesticides and IQ in 7-year-old children. Environ.
 Health Perspect., 119(8), 1189-1195. doi: 10.1289/ehp.1003185.
    Brubaker, C.J., Dietrich, K.N., Lanphear, B.P., & Cecil, K.M.
 (2010). The influence of age of leadexposure on adult gray matter
 volume. Neurotoxicology, 31(3), 259-266. doi: 10.1016/
 j.neuro.2010.03.004.
    Brubaker, C.J., Schmithorst, V.J., Haynes, E.N., Dietrich, K.N.,
 Egelhoff, J.C., Lindquist, D.M., . . . Cecil, K.M. (2009). Altered
 myelination and axonal integrity in adults with childhood lead
 exposure: a diffusion tensor imaging study. Neurotoxicology, 30(6), 867-
 875. doi: 10.1016/j.neuro.2009.07.007.
    Cecil, K.M., Brubaker, C.J., Adler, C.M., Dietrich, K.N., Altaye,
 M., Egelhoff, J.C., . . . Lanphear, B.P. (2008). Decreased brain volume
 in adults with childhood lead exposure. PLoS Med., 5(5), e112. doi:
 10.1371/journal.pmed.0050112.
    Cecil, K.M., Dietrich, K.N., Altaye, M., Egelhoff, J.C., Lindquist,
 D.M., Brubaker, C.J., & Lanphear, B.P. (2011). Proton magnetic
 resonance spectroscopy in adults with childhood lead exposure. Environ.
 Health Perspect., 119(3), 403-408. doi: 10.1289/ehp.1002176.
    Engel, S.M., Berkowitz, G.S., Barr, D.B., Teitelbaum, S.L., Siskind,
 J., Meisel, S.J., . . . Wolff, M.S. (2007). Prenatal organophosphate
 metabolite and organochlorine levels and performance on the Brazelton
 Neonatal Behavioral Assessment Scale in a multiethnic pregnancy cohort.
 Am. J. Epidemiol., 165(12), 1397-1404. doi: 10.1093/aje/kwm029.
    Engel, S.M., Wetmur, J., Chen, J., Zhu, C., Barr, D.B., Canfield,
 R.L., & Wolff, M. S. (2011). Prenatal exposure to organophosphates,
 paraoxonase 1, and cognitive development in childhood. Environ. Health
 Perspect., 119(8), 1182-1188. doi: 10.1289/ehp.1003183.
    Eskenazi, B., Harley, K., Bradman, A., Weltzien, E., Jewell, N.A.,
 Barr, D.B., . . . Holland, N.T. (2004). Association of in utero
 organophosphate pesticide exposure and fetal growth and length of
 gestation in an agricultural population. Environmental Health
 Perspectives, 112(10), 1116-1124. doi: 10.1289/ehp.6789.
    Eskenazi, B., Marks, A.R., Bradman, A., Harley, K., Barr, D.B.,
 Johnson, C., . . . Jewell, N.P. (2007). Organophosphate pesticide
 exposure and neurodevelopment in young Mexican-American children.
 Environ. Health Perspect., 115(5), 792-798. doi: 10.1289/ehp.9828.
    Rauh, V., Arunajadai, S., Horton, M., Perera, F., Hoepner, L., Barr,
 D.B., & Whyatt, R. (2011). Seven-year neurodevelopmental scores and
 prenatal exposure to chlorpyrifos, a common agricultural pesticide.
 Environ. Health Perspect., 119(8), 1196-1201. doi: 10.1289/ehp.1003160.
    Rauh, V.A., Garfinkel, R., Perera, F.P., Andrews, H.F., Hoepner, L.,
 Barr, D.B., . . . Whyatt, R.W. (2006). Impact of prenatal chlorpyrifos
 exposure on neurodevelopment in the first 3 years of life among inner-
 city children. Pediatrics, 118(6), e1845-1859. doi: 10.1542/peds.2006-
 0338.
    Rauh, V.A., Perera, F.P., Horton, M.K., Whyatt, R.M., Bansal, R.,
 Hao, X.J., . . . Peterson, B.S. (2012). Brain anomalies in children
 exposed prenatally to a common organophosphate pesticide. Proceedings
 of the National Academy of Sciences of the United States of America,
 109(20), 7871-7876. doi: 10.1073/pnas.1203396109.
    Whyatt, R.M., Camann, D.E., Kinney, P.L., Reyes, A., Ramirez, J.,
 Dietrich, J., . . . Perera, F.P. (2002). Residential pesticide use
 during pregnancy among a cohort of urban minority women. Environ.
 Health Perspect., 110(5), 507-514.
    Whyatt, R.M., Rauh, V., Barr, D.B., Camann, D.E., Andrews, H.F.,
 Garfinkel, R., . . . Perera, F.P. (2004). Prenatal insecticide
 exposures and birth weight and length among an urban minority cohort.
 Environ. Health Perspect., 112(10), 1125-1132.
    Wright, J.P., Dietrich, K.N., Ris, M.D., Hornung, R.W., Wessel,
 S.D., Lanphear, B.P., . . . Rae, M.N. (2008). Association of prenatal
 and childhood blood lead concentrations with criminal arrests in early
 adulthood. PLoS Med., 5(5), e101. doi: 10.1371/journal.pmed.0050101.
 

Appendix 6. Addendum 1: Columbia University Epidemiology Studies
    The agency is obligated to review and address peer review comments 
in support of regulatory decisions. The following is a list of key 
issues about the epidemiological studies carried out by researchers at 
Columbia University that were raised in peer review comments. These 
issues require EPA to have access to the raw data for additional 
analyses by the agency.

  (1)  Further analysis of other chemical exposures (e.g., lead, PAHs, 
            other pesticides) to address, if possible, their impact or 
            contribution as modulating factors on the measured 
            outcomes.

     2012 SAP--``it should be noted that it cannot be stated 
            that chlorpyrifos is the sole contributor to the observed 
            outcomes.''

     2012 SAP--``In an earlier examination of the same cohort, 
            Perera, et al. (2009) reported an association between a 
            decrease in full-scale IQ and verbal IQ in 5-year-olds with 
            prenatal polycyclic aromatic hydrocarbons (PAH) exposure 
            rather than chlorpyrifos, thus, raising an issue of the 
            shift in chemical exposure association with increase in 
            age. In each of these analyses, statistical modeling showed 
            that the exposures were independently associated with IQ, 
            and no significant interaction was observed with the other 
            chemical. While this is a statistically sound approach to 
            determine independent responses, panel members noted that 
            it is very difficult to identify the independent 
            physiological effects of a single chemical in this type of 
            multi-chemical exposure scenario.''

     2012 Federal Peer Review--``even low levels of lead can 
            impact neurodevelopment, and even that the observed 
            neurobehavioral deficits are more pronounced at lower blood 
            lead levels when compared with higher blood lead levels''.

     2008 SAP--``In order to eliminate the possible causes of 
            neurodevelopmental effects by other pesticides in the 
            Columbia study, it is suggested that EPA should repeat the 
            pre-post residential cancellation analysis done for 
            chlorpyrifos using other pesticide measurements, such as 
            malathion diacid (MDA), a specific metabolite of malathion. 
            The outcomes from those additional analyses will either 
            confirm or reject EPA's preliminary conclusion that 
            chlorpyrifos is likely to play a role in the 
            neurodevelopmental outcomes.''

     2008 SAP--``It would be useful to examine the results of a 
            statistical analysis that includes all three AChE-
            inhibiting insecticides in the analysis model as 
            dichotomous variables (above or below LOD) in combination 
            with continuous measurements for these variables. This type 
            of analysis would likely not change the results, but it 
            could be helpful in illustrating threshold or dose response 
            effects.''

  (2)  Further analysis and information to address and, if possible, 
            better characterize uncertainty around outcome measures on 
            learning/memory/IQ.

     2012 SAP--Alternative considerations for non-quantified 
            samples: ``little use was made of techniques to integrate 
            non-quantified samples into the statistical test . . . . 
            Various methods were reviewed by the July 2010 SAP that can 
            be applied to either normally or lognormally distributed 
            data that include a significant (even a majority) of non-
            detectable sample . . . . Specifically, the use of 
            `probability plots' was described that can yield an 
            estimate of the geometric mean of the distribution [GM], 
            the geometric standard deviation [GSD], and corresponding 
            percentiles.''

     Federal Peer Review--``There is a scatterplot showing the 
            raw scores for overall IQ and for each of the subtests, but 
            it is not possible to obtain the necessary information to 
            compare the distributions of these scores with the norms 
            for the test or with any other study sample. Ideally, the 
            means and standard deviations for these scores should be 
            presented for either a non-exposed or a non-exposed 
            combined with low exposed group and these should be 
            compared to a moderate or high-exposed group as was done 
            for the BSID-II in the Rauh, et al., 2006 paper. Here the 
            uncertainties stem from the assumptions that are made when 
            regression analyses are performed. The main issue here is 
            that outliers can greatly influence the slope of the 
            function.''

       Federal Peer Review--A between group analysis using 
            inferential statis-
              tics, as was done for the Bayley Scales of Infant 
            Development II in the
              Rauh, et al., 2006 paper, should be performed on each 
            variable in both stud-
              ies (i.e., the Child Behavior Checklist in Rauh, et al., 
            2006, and the full
              scale IQ and subscales for the WISC-IV in the Rauh, et 
            al., 2011 study).
              This would be the most direct and least problematic 
            method for deter-
              mining whether exposure to chlorpyrifos resulted in 
            significant decreases in
              IQ or significant increases in behavioral problems ``. . 
            . no information was
              provided regarding the qualifications of the individuals 
            who administered
              and scored the tests. ''

  (3)  Further analysis to assess, if possible, whether individual 
            cohort members had the potential for exposure to 
            chlorpyrifos and/or other acetylcholinesterase (AChE) 
            inhibiting pesticides (e.g., diazinon, propoxur), 
            prenatally and/or postnatally, at levels leading to greater 
            than 10% AChE inhibition (the level used to derive the 
            regulatory point of departure).

     2012 SAP--recommended conducting a dose reconstruction 
            analysis--``data on the concentration of chlorpyrifos in 
            various media (i.e., house dust, air and water) while 
            market basket data exists on the concentration of 
            chlorpyrifos on food. These data provide the main tools for 
            developing an effective exposure assessment and a 
            subsequent reconstruction of potential dose.'' The agency 
            has begun such analysis but the current draft analysis is 
            limited without data on the exposure information relevant 
            to individual women such that environmental chlorpyrifos 
            exposure can then be linked to measures of blood 
            chlorpyrifos.

     2012 SAP--recommended the agency consider issues related 
            to multiple chemical exposure (i.e., mixtures) to 
            chlorpyrifos and other key AChE inhibiting pesticides 
            identified by the Columbia University studies (diazinon, 
            propoxur). Assumptions of co-exposure will likely be 
            grossly over-estimated without access to the raw data; such 
            raw data may enable the agency to evaluate actual co-
            exposure information for individuals from air monitoring 
            samples and blood samples.
                             [attachment 6]
    [https://www.epa.gov/pesticide-science-and-assessing-pesticide-
risks/about-water-exposure-models-used-pesticide]
About Water Exposure Models Used in Pesticide [Assessments]
On this Page
   General Information about Water Models

     Model Names and Specific Uses

   Surface Water Models

     GENEEC

     FIRST

     Surface Water Concentration Calculator

     Tier 1 Rice Model

     PFAM

     KABAM

   Ground Water Models

     SCI-GROW

     PRZM-GW

   References
Water Models
    When EPA's Office of Pesticide Programs (OPP) assesses the risk of 
a pesticide, it considers the exposure to the pesticide as well as the 
toxicity of the pesticide. For both drinking water and aquatic exposure 
assessments, reliable field monitoring data, when available, as well as 
mathematical models can be used to generate exposure estimates. 
Monitoring and modeling are both important tools for assessing 
pesticide concentrations in water and can provide different types of 
information. Monitoring tells the user what is happening under current 
use practices and under typical conditions. Although monitoring data 
can provide a direct estimate of the concentration of a pesticide in 
water at a particular time and at a particular location, it may not 
provide reliable estimates for exposure assessments because sampling 
may not occur where and when the highest concentrations of a pesticide 
are found.
    For drinking water and aquatic exposures assessments, OPP typically 
relies on mathematical models to generate exposure estimates. These 
models calculate estimated environmental concentrations (EECs) using 
laboratory data that describe how fast the pesticide breaks down to 
other chemicals and how it moves in the environment. The guidelines for 
these laboratory studies can be found at the following website: Series 
835--Fate, Transport and Transformation Test Guidelines (https://
www.epa.gov/test-guidelines-pesticides-and-toxic-substances/series-835-
fate-transport-and-transformation-test). Although computer modeling 
provides an indirect estimate of pesticide concentrations, models can 
estimate concentrations continuously over long periods of time and for 
vulnerable areas of interest for a particular pesticide. Modeling can 
also be used to compare estimated concentrations with toxicity data to 
determine the risk a pesticide poses to both drinking water and aquatic 
systems. Another benefit of computer modeling is in determining how 
various mitigation practices affect the amount of the pesticide that 
can run off into water.
    In estimating pesticide concentrations in aquatic environments, OPP 
uses a tiered approach. The intent of this approach is to estimate 
pesticide concentrations in water from sites that are highly vulnerable 
to runoff or leaching. With this approach, pesticides that pass Tier I 
will likely pose a low possibility of harming human health, wildlife, 
or the environment. Failing a tier, however, does not necessarily mean 
the chemical is likely to cause health or environmental problems, but 
rather that there is a need to move to a higher tier and conduct a more 
refined assessment. This tiered modeling system is designed to provide 
a thorough analysis of each pesticide, while at the same time focus 
OPP's efforts on those pesticides that pose the greatest potential 
risk. For more information on this approach, refer to the archives 
about Science Policy Issues and Guidance Documents related to Tolerance 
Reassessment Advisory Committee (TRAC). Search EPA Archive (https://
archive.epa.gov/).
Model Names and Specific Uses
    For estimating upper bound concentrations of pesticides in drinking 
water, OPP uses FIRST (FQPA Index Reservoir Screening Tool) as a Tier I 
model for surface water exposure assessments and PRZM-GW for 
groundwater exposure assessments. For estimating upper bound 
concentrations of pesticides in other aquatic environments, OPP uses 
the Tier I model GENEEC2 (GENeric Estimated Environmental 
Concentration) for surface water exposure assessments. View these and 
other models (https://www.epa.gov/pesticide-science-and-assessing-
pesticide-risks/models-pesticide-risk-assessment).
    For Tier II surface water exposure assessments, OPP uses the 
Surface Water Concentration Calculator (SWCC), which accommodates the 
specific characteristics of the chemical and includes more site-
specific information regarding the application method and impact of 
local daily weather on the treated field over a period of 30 years. At 
the Tier II level, the SWCC uses maximum application rates and 
frequencies for a vulnerable drinking water reservoir or vulnerable 
pond. Additional refinements in application rates may be considered if 
usage data indicate they are appropriate. Currently, scientists in the 
Environmental Fate and Effects Division (EFED) of the Office of 
Pesticide Programs (OPP) are exploring the use of the SWCC for Tier I 
level assessments. View the SWCC and other models (https://www.epa.gov/
pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-
assessment).
    For Tier II groundwater exposure assessments, refinement strategies 
for PRZM-GW can be used to estimate pesticide concentrations in 
groundwater. These refinement strategies include consideration of 
representative scenarios, additional fate parameters, annual 
application retreatment, well setbacks, and representative exposure 
durations of concern.
    Although exposure models make it easy to evaluate the impacts of 
numerous variables in the environment, the results of these models are 
highly dependent on the accuracy of the chemical parameters that are 
used as inputs and the ability of the model to represent what occurs in 
the environment. In order to improve transparency and confidence in 
these models, EFED Scientists present new model developments at the 
Environmental Modeling Public Meetings (EMPM) (https://www.epa.gov/
pesticide-science-and-assessing-pesticide-risks/environmental-modeling-
public-meeting-information), which are held on a semiannual basis. In 
addition, the code and documentation for all EFED/OPP water models are 
posted on the web page for models used in pesticide risk assessment 
(https://www.epa.gov/pesticide-science-and-assessing-pesticide-risks/
models-pesticide-risk-assessment).
    The following is a more detailed summary of OPP's current Tier I 
and Tier II aquatic exposure models along with links to user manuals 
that can be downloaded.
Surface Water Models
    Pesticides can enter surface waters through runoff, spray drift, 
and deposition. Once pesticides have entered surface waters, they are 
exposed to a number of physical, chemical, and microbial processes that 
impact the fate of the pesticides. These processes include 
photodegradation, volatilization, biodegradation, absorption/
adsorption, chemical degradation, leaching, and sedimentation. To 
better understand the fate of pesticides in surface waters, OPP has 
developed a number of models that capture these processes and predict 
the concentration of pesticides in surface waters. These models range 
from simple screening models that require few inputs to more complex 
models that reflect the dynamics of the surface water ecosystem. Below 
is a description of the surface water models that OPP uses in its 
pesticide exposure assessments.
GENEEC2
    The GENeric Estimated Environmental Concentration (GENEEC 2.1) is a 
screening model to predict environmental concentrations of pesticides 
in surface water for aquatic exposure assessments. The model, which was 
recompiled to operate in the Microsoft' Windows 
7' environment, is a legacy model for EPA and is currently 
available on the Water Models--Previous Versions (https://www.epa.gov/
pesticide-science-and-assessing-pesticide-risks/pesticide-water-models-
previous-versions#
geneec2) Web page. For the most part, the Surface Water Concentration 
Calculator (SWCC) has replaced GENEEC2 for estimating environmental 
concentrations of pesticides in surface water for aquatic exposure 
assessments. View current models (https://www.epa.gov/pesticide-
science-and-assessing-pesticide-risks/models-pesticide-risk-
assessment).
    In the past, OPP used GENEEC2 as a Tier I screening model for 
assessing exposure of aquatic organisms and the environment to 
pesticides. GENEEC2 provides a rapid screen to separate the low risk 
pesticides from those that need more refined assessments. The model 
estimates high level exposure values of pesticides in surface water 
from a few basic chemical characteristics and pesticide label use and 
application information.
    GENEEC2 considers adsorption of the pesticide to soil or sediment, 
incorporation of the pesticide at application, direct deposition of 
spray drift into the water body, and degradation of the pesticide in 
soil before runoff and within the water body. It is a single-event 
model, meaning that it assumes one single large rainfall/runoff event, 
which occurs on a 10-hectare field and which removes a large quantity 
of pesticide at one time from the field to a pond. In this case, the 
pond has a 20,000 cubic water volume and is 2 meters deep. The GENEEC2 
program is generic in that it does not consider differences in climate, 
soils, topography or crop in estimating potential pesticide exposure.
    GENEEC2 is expected to overestimate pesticide concentrations in 
surface water for most sites and may be inappropriate for some 
chemicals, especially those that are persistent and/or have a high 
sorption coefficient, as well as frequently applied pesticides. In 
these cases, users should go directly to a higher tiered assessment 
using the more sophisticated Surface Water Concentration Calculator 
discussed below.
FIRST
    OPP uses the Tier I model, FQPA Index Reservoir Screening Tool 
(FIRST), to assess exposure to pesticides in drinking water. Using a 
few basic chemical parameters (e.g., half-life in soil) and pesticide 
label application information, FIRST estimates peak values (acute) and 
long-term (chronic) average concentrations of pesticides in water. Like 
GENEEC, it is based upon the linked PRZM and EXAMS models and is a 
single-event process. However, it is different from GENEEC in several 
aspects. As with the Tier II modeling for drinking water, FIRST uses an 
Index Reservoir (https://www.epa.gov/pesticide-science-and-assessing-
pesticide-risks/development-and-use-index-reservoir-drinking-water) 
watershed based on the Shipman City Lake in Illinois.
    FIRST also uses Percent Cropped Area (PCA) factors, which consider 
the percentage of the watershed that is cropped rather than assuming 
that the whole watershed is cropped. The program automatically adjusts 
the output in accordance with the user-specified maximum percent of 
crop area in any watershed. For more information, see the FIRST User's 
Manual (https://www.epa.gov/pesticide-science-and-assessing-pesticide-
risks/first-version-10-users-manual) and Model Description.
Surface Water Concentration Calculator
    Currently, OPP uses the Surface Water Concentration Calculator 
(SWCC) for higher level, refined (Tier II) estimations of pesticide 
concentrations in surface waters for drinking water and aquatic 
exposure assessments. The SWCC is designed to simulate the 
environmental concentration of a pesticide in the water column and 
sediment and is used for regulatory purposes by the EPA's Office of 
Pesticide Programs (OPP). The SWCC uses the Pesticide Root Zone Model 
(PRZM) version 5.0+ (PRZM5) and the Variable Volume Water Body Model 
(VVWM), replacing the older PE5 shell (last updated November 2006), 
which used PRZM3 (Carousel, et al., 2005) and EXAMS (Burns, 2004). This 
updated model was designed to improve users' interactions with the 
program and facilitate maintenance and operation of the software.
    For aquatic assessments, the SWCC uses the standard pond scenario, 
and for drinking water assessments, the SWCC uses the index reservoir/
percent crop area factors.
    PRZM5 is a process or ``simulation'' model that calculates what 
happens to a pesticide in a farmer's field on a day-to-day basis. It 
considers factors such as rainfall and evapotranspiration as well as 
how and when the pesticide is applied. It has two major components: 
hydrology and chemical transport. The hydrologic component for 
calculating runoff and erosion of soil is based on the Soil 
Conservation Service curve number technique and the Universal Soil Loss 
Equation (NRCS, 2003; Wischmeier and Smith, 1978).
    Evapotranspiration of water is estimated from pan evaporation data. 
Total evapotranspiration of water includes evaporation from crop 
interception, evaporation from soil, and transpiration by the crop. 
Water movement is simulated by the use of generalized soil parameters, 
including field capacity, wilting point, and curve number. The chemical 
transport component simulates pesticide application on the soil or on 
the plant foliage. Dissolved, sorbed, and vapor-phase concentrations in 
the soil are estimated by considering surface runoff, erosion, 
degradation, volatilization, foliar washoff, advection, dispersion, 
retardation, among others.
    Each PRZM5 modeling scenario represents a unique combination of 
climatic conditions, crop specific management practices, soil specific 
properties, site specific hydrology, and pesticide specific application 
and dissipation processes. Each simulation is conducted using multiple 
years of rainfall data to cover year-to-year variability in runoff. 
Daily edge-of-field loadings of pesticides dissolved in runoff waters 
and sorbed to sediment, as predicted by PRZM5, are discharged into a 
standard water body (either the standard pond or the Index Reservoir) 
simulated by the VVWM model. Additional information about the PRZM5 
model can be found on our models page (https://www.epa.gov/pesticide-
science-and-assessing-pesticide-risks/models-pesticide-risk-
assessment).
    The VVWM simulates the processes that occur in the water body by 
using the runoff and spray drift loading generated by PRZM5 to estimate 
the fate, persistence, and concentration of a pesticide in a water body 
on a day-to-day basis. As such, the model accounts for volatilization, 
sorption, hydrolysis, biodegradation, and photolysis of the pesticide. 
The VVWM has the ability to vary its volume on a daily scale and to 
include sediment burial (unlike its predecessor EXAMS) although these 
feature are only used for higher tiered assessments.
    Multiple year pesticide concentrations in the water column are 
calculated from the simulations as the annual daily peak, maximum 
annual 96-hour average, maximum annual 21-day average, maximum annual 
60-day average, and annual average. The upper 10th percentile 
concentrations (except annual average) are compared against 
ecotoxicological and human health levels of concern (LOC). For a more 
detailed description of the parameters, validations and assessments for 
VVWM, see our information on aquatic models (https://www.epa.gov/
pesticide-science-and-assessing-pesticide-risks/models-pesticide-risk-
assessment).
Tier 1 Rice Model
    The Tier 1 Rice Model (version 1.0) is used to estimate surface 
water exposure from the use of pesticides in rice paddies. This 
screening-level model provides short- and long-term concentrations that 
can be used for both aquatic ecological risk assessments and drinking 
water exposure assessments. Guidance for using the Tier 1 Rice Model 
can be found on our models page (https://www.epa.gov/pesticide-science-
and-assessing-pesticide-risks/models-pesticide-risk-assessment).
Pesticide in Flooded Application Model (PFAM)
    Compared to the Tier 1 Rice Model, PFAM allows for a more advanced 
estimate of surface water exposure from the use of pesticides in 
flooded fields such as rice paddies and cranberry bogs. Some of the 
advanced features incorporated into PFAM include specifications for 
water and pest management practices, degradation data for soil and 
aquatic environments and post-processing information of discharged 
paddy waters to a stream. Additional information concerning PFAM can be 
found on our models page (https://www.epa.gov/pesticide-science-and-
assessing-pesticide-risks/models-pesticide-risk-assessment).
Aquatic Bioaccumulation Model
    EPA uses the model KABAM version 1.0 (Kow (based) Aquatic 
Bioaccumulation Model) to estimate potential bioaccumulation of 
hydrophobic organic pesticides in freshwater aquatic food webs and 
subsequent risks to mammals and birds via consumption of contaminated 
aquatic prey. The model can also be used to estimate pesticide 
concentrations in fish tissues consumed by humans. KABAM is composed of 
two parts: (1) a bioaccumulation model estimating pesticide 
concentrations in aquatic organisms and (2) a risk component that 
translates exposure and toxicological effects of a pesticide into risk 
estimates for mammals and birds consuming contaminated aquatic prey. 
The users manual and executable file for KABAM can be found on our 
models page (https://www.epa.gov/pesticide-science-and-assessing-
pesticide-risks/models-pesticide-risk-assessment).
Ground Water Models
SCI-GROW
    After the passage of the Food Quality Protection Act (FQPA) of 
1996, the EPA developed SCI-GROW (Screening Concentration in 
Groundwater) as a screening-level tool to estimate drinking water 
exposure concentrations in groundwater resulting from pesticide use 
(Barrett, 1997). As a screening tool, SCI-GROW provides conservative 
estimates of pesticides in groundwater, but it does not have the 
capability to consider variability in leaching potential of different 
soils, weather (including rainfall), cumulative yearly applications or 
depth to aquifer. If SCI-GROW-based assessment results indicate that 
pesticide concentrations in drinking water exceed levels of concern, 
the ability to refine the assessment is limited. At the present time, 
SCI-GROW is considered a legacy model for EPA and has been largely 
replaced by PRZM-GW.
PRZM-GW
    In 2004, the EPA and the Pest Management Regulatory Agency (PMRA)--
Canada initiated a project to evaluate advanced methods for estimating 
pesticide concentrations in groundwater. The goals of this project were 
to identify a common computer model for estimating pesticide 
concentrations in groundwater and to develop common procedures for 
determining model input parameters from soil survey data, pesticide 
environmental fate studies, and pesticide use information. After 
evaluating 19 modeling programs, EPA and PMRA selected a modified 
version of PRZM as the North American Free Trade Agreement (NAFTA) 
regulatory tool for estimating concentrations of pesticides in ground 
water. Concurrently, EPA consulted with the FIFRA Scientific Advisory 
Panel (SAP) twice in 2005 on the development of a groundwater 
conceptual model and the use of PRZM-GW to implement the conceptual 
model.
    Figure 2 depicts the general groundwater scenario concept for 
estimating pesticide concentrations in drinking water as implemented in 
PRZM-GW. This conceptual model is based on a rural drinking water well 
beneath an agricultural field (a high pesticide use area), which draws 
water from an unconfined, high water-table aquifer.
Figure 2: General Groundwater Scenario Concept for Estimating Pesticide 
        Concentrations in Drinking Water As Implemented in PRZM-GW
        
       [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] 
        
        
    The depth of the well is site-specific (i.e., scenario specific). 
The well extends into a shallow unconfined aquifer and has a well-
screen that starts at the top and continues down into the aquifer. The 
length of the well-screen represents the region of the aquifer where 
drinking water is collected. The well-screen length is well-specific 
and can be adjusted. Processes included in the conceptual model that 
influence pesticide transport through the soil profile include water 
flow, chemical specific dissipation and transportation parameters 
(i.e., degradation and sorption), and crop specific factors, including 
transpiration, pesticide interception and management practices.
    After developing the conceptual model for PRZM-GW, EPA compared its 
performance in estimating drinking water concentrations of pesticides 
with targeted and non-targeted groundwater monitoring data. Data from 
prospective ground water monitoring studies (detailed site 
investigations of pesticide leaching into vulnerable aquifers) were 
important in the development and evaluation of the PRZM-GW model. After 
an extensive evaluation, EPA determined that PRZM-GW was an effective 
tool for establishing upper bound pesticide concentrations in 
groundwater for national and site-specific assessments.
    Initially, EPA implemented PRZM-GW using a Tier I procedure that 
involves simulation of 30 to 100 years of pesticide applications at 
labeled maximum application rates in defined scenarios that represent 
the most vulnerable types of aquifers utilized as drinking water 
sources. These studies showed that the primary pesticide-specific 
inputs affecting PRZM-GW exposure estimates are the application rate 
and timing, the aerobic soil degradation rate, the linear adsorption 
coefficient, and the hydrolysis rate. For volatile pesticides such as 
fumigants, a volatilization routine can also be incorporated in the 
model run.
    After evaluating PRZM-GW as an effective tool for establishing Tier 
I screening assessments, EPA developed refinement strategies for using 
PRZM-GW for Tier II groundwater assessments. These refinement 
strategies can include consideration of representative scenarios, 
additional fate parameters, annual application retreatment, well 
setbacks, and representative exposure durations of concern. In the 
future, OPP may consider additional strategies to facilitate such 
refinements. For more information, refer to EPA's Guidance for Using 
PRZM-GW in Drinking Water Exposure Assessments (https://www.epa.gov/
pesticide-science-and-assessing-pesticide-risks/przm-gw-version-107-
guidance-using-przm-gw-drinking).
References
    Barrett, M. 1997. Initial Tier Screening of Pesticides for 
Groundwater Concentration Using the SCI-GROW Model. U.S. Environmental 
Protection Agency. Washington, D.C.
    Burns, L. 2004. Exposure Analysis Modeling System (EXAMS) (https://
www.epa.gov/exposure-assessment-models/exams-version-index). User's 
manual and system documentation. Ecosystems Research Division. U.S. 
Environmental Protection Agency. Athens, GA. EPA/600/R-081. September 
2000. Revision G.
    Carousel, R.F., J.C. Imhoff, P.R. Hummel, J.M. Cheplick, A.S. 
Donigian, and L.A. Suarez. 2005. U.S. Environmental Protection Agency. 
Athens, GA. Pesticide Root Zone Model (PRZM)-3. PRZM: a model for 
predicting pesticide and nitrogen fate in the crop root and unsaturated 
soil zones. 3.12.2 ed.
    NRCS, 2003. National Engineering Handbook Section 4: Hydrology. 
Natural Resources Conservation Service, U.S. Department of Agriculture, 
Washington D.C.
    Wischmeier, W.H., and D.D. Smith. 1978. Predicting rainfall erosion 
losses--a guide to conservation planning. Agriculture Handbook 537, 
U.S. Department of Agriculture, Washington, D.C., USA.
    Contact Us (https://www.epa.gov/pesticide-science-and-assessing-
pesticide-risks/forms/contact-us-about-pesticide-science-and) to ask a 
question, provide feedback, or report a problem.

          [Accessed September 8, 2016]
                             [attachment 7]
    [http://www.ecfr.gov/cgi-bin/text-
idx?SID=3f455fd5338126f4f8c99664dbbbe1b2 
&mc=true&node=ap40.24.127_127.a&rgn=div9]

    e-CFR data is current as of September 2, 2016.
Electronic Code of Federal Regulations
Title 40: Protection of Environment
Part 127--NPDES Electronic Reporting
Subpart C--Responsibilities of EPA and States, Tribes, and Territories 
        Authorized to Implement the NPDES Program
Appendix A to Part 127--Minimum Set of NPDES Data
    The following two tables identify the minimum set of NPDES data 
that authorized states, tribes, territories must enter or transfer to 
EPA's national NPDES data system as well as what NPDES-regulated 
entities must electronically report to the designated initial recipient 
(authorized NPDES program or EPA) [see 40 CFR 127.2(b)]. Authorized 
NPDES programs will be the data provider in the event the regulated 
entity is covered by a waiver from electronic reporting. Use of these 
two tables ensures that there is consistent and complete reporting 
nationwide, and expeditious collection and processing of the data, 
thereby making it more accurate and timely. Taken together, these data 
standardizations and the corresponding electronic reporting 
requirements in 40 CFR parts 3, 122, 123, 124, 125, 127, 403, and 503 
are designed to save the NPDES authorized programs considerable 
resources, make reporting easier for NPDES-regulated entities, 
streamline permit renewals (as permit writers typically review previous 
noncompliance events during permit renewal), ensure full exchange of 
NPDES program data between states and EPA to the public, improve 
environmental decision-making, and protect human health and the 
environment.
    Authorized NPDES programs may also require NPDES regulated entities 
to submit more data than what is listed in this appendix. The 
authorized NPDES program can require NPDES regulated entities to submit 
these ``non-appendix A'' data on paper, electronically, or attachments 
to electronic notices and reports filed in compliance with this part.
    Instructions: Table 1 of this appendix provides the list of data 
sources and minimum submission frequencies for the ten different NPDES 
Data Groups. Table 2 of this appendix provides the data that must be 
electronically reported for each of these NPDES Data Groups. The use of 
each data element is determined by identifying the number(s) in the 
column labeled ``NPDES Data Group Number'' in Table 2 and finding the 
corresponding ``NPDES Data Group Number'' in Table 1. For example, a 
value of ``1'' in Table 2 means that this data element is required in 
the electronic transmission of data from the NPDES program to EPA (Core 
NPDES Permitting, Compliance, and Enforcement Data). Likewise, a value 
of ``1 through 10'' in Table 2 means that this data element is required 
in all ten NPDES data groups. NPDES regulated entities that have no 
historical record (e.g., ``greenfield'' facilities) do not need to 
provide data elements that rely on historical data elements. For the 
purposes of this appendix, the term `sewage sludge' [see 40 CFR 
503.9(w)] also refers to the material that is commonly referred to as 
`biosolids.' EPA does not have a regulatory definition for biosolids 
but this material is commonly referred to as sewage sludge that is 
placed on, or applied to the land to use the beneficial properties of 
the material as a soil amendment, conditioner, or fertilizer. EPA's use 
of the term `biosolids' in this appendix is to confirm that information 
about beneficially used sewage sludge (a.k.a. biosolids) is part of the 
data collected in this appendix.

                                                   Table 1--Data Sources and Regulatory Citations \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
  NPDES Data
 group No. \2\              NPDES data group                 Program area      Data provider                      Minimum frequency \3\
--------------------------------------------------------------------------------------------------------------------------------------------------------
1               Core NPDES Permitting, Compliance, and    All NPDES Program  Authorized NPDES   Within 40 days of the completed activity or within 40
                 Enforcement Data [40 CFR parts 122,       Sectors            Program            days of receipt of a report from a regulated entity
                 123, 403, 503]                                                                  [see  127.23(a)(1)]. However, the frequency associated
                                                                                                 with any particular permittee may be considerably less
                                                                                                 [e.g., once every five years for most permit
                                                                                                 information].
2               General Permit Reports [Notices of        All NPDES Program  NPDES Permittee    Prior to obtaining coverage under a general permit or
                 Intent to discharge (NOIs); Notices of    Sectors                               consideration for permit exclusion or waiver from
                 Termination (NOTs); No Exposure                                                 permitting, and permit coverage termination. General
                 Certifications (NOEs); Low Erosivity                                            permits are generally issued once every five years.
                 Waivers and Other Waivers from
                 Stormwater Controls (LEWs)] [40 CFR
                 122.26(b)(15), 122.28 and 124.5]
3               Discharge Monitoring Reports [40 CFR      Most NPDES         NPDES Permittee    At least annual, more frequent submissions may be
                 122.41(l)(4)]                             Program Sectors                       required by the permit.
4               Sewage Sludge/Biosolids Annual Program    Sewage Sludge/     NPDES Regulated    Annual.
                 Reports [40 CFR part 503]                 Biosolids          Sewage Sludge/
                                                                              Biosolids
                                                                              Generator and
                                                                              Handler
5               Concentrated Animal Feeding Operation     CAFO               CAFO               Annual.
                 (CAFO) Annual Program Reports [40 CFR
                 122.42(e)(4)]
6               Municipal Separate Storm Sewer System     MS4                NPDES Permittee    Year two and year four of permit coverage (Small MS4),
                 (MS4) Program Reports [40 CFR                                                   Annual (Medium and Large MS4).
                 122.34(g)(3) and 122.42(c)]
7               Pretreatment Program Reports [40 CFR      Pretreatment       POTW Pretreatment  Annual.
                 403.12(i)]                                                   Control
                                                                              Authority,
                                                                              Approval
                                                                              Authority for
                                                                              SIUs in
                                                                              Municipalities
                                                                              Without Approved
                                                                              Pretreatment
                                                                              Programs
8               Significant Industrial User Compliance    Pretreatment       Significant        Bi-Annual.
                 Reports in Municipalities Without                            Industrial User
                 Approved Pretreatment Programs [40 CFR
                 403.12(e) and (h)]
9               Sewer Overflow Event Reports [40 CFR      Sewer Overflows    NPDES Permittee    Within 5 days of the time the permittee becomes aware of
                 122.41(l)(6) and (7)]                                                           the sewer overflow event (health or environment
                                                                                                 endangerment), Monitoring report frequency specific in
                                                                                                 permit (all other sewer overflow events).
10              CWA section 316(b) Annual Reports [40     CWA section        NPDES Permittee    Annual.
                 CFR part 125, subpart J]                  316(b)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Entities regulated by a NPDES permit will comply with all reporting requirements in their respective NPDES permit.
\2\ Use the ``NPDES Data Group Number'' in this table and the ``NPDES Data Group Number'' column in Table 2 of this appendix to identify the source of
  the required data entry. EPA notes that electronic systems may use additional data to facilitate electronic reporting as well as management and
  reporting of electronic data. For example, NPDES permittees may be required to enter their NPDES permit number (``NPDES ID''--NPDES Data Group 1 and
  2) into the applicable electronic reporting system in order to identify their permit and submit a Discharge Monitoring Report (DMR-NPDES Data Group
  3). Additionally, NPDES regulated entities may be required to enter and submit data to update or correct erroneous data. For example, NPDES permittees
  may be required to enter new data regarding the Facility Individual First Name and Last Name (NPDES Data Group 1 and 2) with their DMR submission when
  there is a facility personnel change.
\3\ The applicable reporting frequency is specified in the NPDES permit or control mechanism, which may be more frequent than the minimum frequency
  specified in this table.


                                                          Table 2--Required NPDES Program Data
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                              NPDES data
                                                                                                       CWA, regulatory (40 CFR), or other     group No.
                Data name                                     Data description                                      citation                  (see Table
                                                                                                                                                  1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                               Basic Facility Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
      [Note: As indicated in the ``CWA, Regulatory, or Other Citation'' column, some of these data elements apply to Significant Industrial Users (SIUs)
   and Categorical Industrial Users (CIUs) that discharge (including non-domestic wastewater delivered by truck, rail, and dedicated pipe or other means
   of transportation) to one or more POTWs and to regulated entities or locations that generate, process, or receive biosolids or sewage sludge.]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facility Type of Ownership                The unique code/description identifying the type of       122.21, 122.21(j)(6), 122.21(q),         1, 2, 4,
                                           facility (e.g., state government, municipal or water      122.28(b)(2)(ii), 403.8(f), 403.10,      and 7.
                                           district, Federal facility, tribal facility). This data   403.12(i), 503.18, 503.28, 503.48
                                           element is used by EPA's national NPDES data system to
                                           identify the facility type (e.g., POTW, Non-POTW, and
                                           Federal)
Facility Site Name                        The name of the facility                                  122.21, 122.21(j)(6), 122.21(q),         1, 2, 4,
                                                                                                     122.28(b)(2)(ii), 122.44(j), 403.8(f),   and 7.
                                                                                                     403.10, 403.12(i), 503.18, 503.28,
                                                                                                     503.48
Facility Site Address                     The address of the physical facility location             122.21, 122.21(j)(6), 122.21(q),         1, 2, 4,
                                                                                                     122.28(b)(2)(ii), 122.44(j), 403.8(f),   and 7.
                                                                                                     403.10, 403.12(i), 503.18, 503.28,
                                                                                                     503.48
Facility Site City                        The name of the city, town, village, or other locality,   122.21, 122.21(j)(6), 122.21(q),         1, 2, 4,
                                           when identifiable, within which the boundaries (the       122.28(b)(2)(ii), 122.44(j), 403.8(f),   and 7.
                                           majority of) the facility site is located. This is not    403.10, 403.12(i), 503.18, 503.28,
                                           always the same as the city used for USPS mail delivery   503.48
Facility Site State                       The U.S. Postal Service (USPS) abbreviation for the       122.21, 122.21(j)(6), 122.21(q),         1, 2, 4,
                                           state or state equivalent for the U.S. where the          122.28(b)(2)(ii), 122.44(j), 403.8(f),   and 7.
                                           facility is located                                       403.10, 403.12(i), 503.18, 503.28,
                                                                                                     503.48
Facility Site Zip Code                    The combination of the 5-digit Zone Improvement Plan      122.21, 122.21(j)(6), 122.21(q),         1, 2, 4,
                                           (ZIP) code and the 4-digit extension code (if             122.28(b)(2)(ii), 122.44(j), 403.8(f),   and 7.
                                           available) where the facility is located. This zip code   403.10, 403.12(i), 503.18, 503.28,
                                           match the ``Facility Site City'' or the city used for     503.48
                                           USPS mail delivery
Facility Site Tribal Land Indicator       The EPA Tribal Internal Identifier for every unit of      122.21, 122.21(q), 122.28(b)(2)(ii),     1, 2, and
                                           land trust allotment (``tribal land'') within Indian      503.18, 503.28, 503.48                   4.
                                           Country (i.e., Federally recognized American Indian and
                                           Alaska Native tribal entities). This unique identifier
                                           will identify whether the facility is on tribal land
                                           and the current name of the American Indian tribe or
                                           Alaskan Native entity. This unique identifier is
                                           different from the Bureau of Indian Affairs tribal code
                                           and does not change when a Tribe changes its name
Facility Site Longitude                   The measure of the angular distance on a meridian east    122.21, 122.21(q), 122.28(b)(2)(ii),     1, 2, and
                                           or west of the prime meridian for the facility. The       503.18, 503.28, 503.48                   4.
                                           format for this data element is decimal degrees (e.g.,
                                           ^77.029289) and the WGS84 standard coordinate system.
                                           This data element will also be used to describe the two-
                                           dimensional area (polygon) regulated by a municipal
                                           storm sewer system (MS4) NPDES permit through use of
                                           multiple latitude and longitude coordinates. For MS4
                                           the polygon data should provide a reasonable estimate
                                           of the MS4 boundaries. This data element can also be
                                           system generated when the Facility Site Address,
                                           Facility Site City, and Facility Site State data
                                           elements can be used to generate accurate longitude and
                                           latitude values. (Note: ``Post Office Box'' addresses
                                           and ``Rural Route'' addresses are generally not
                                           geocodable)
Facility Site Latitude                    The measure of the angular distance on a meridian north   122.21, 122.21(q), 122.28(b)(2)(ii),     1, 2, and
                                           or south of the equator for the facility. The format      503.18, 503.28, 503.48                   4.
                                           for this data element is decimal degrees (e.g.,
                                           38.893829) and the WGS84 standard coordinate system.
                                           This data element will also be used to describe the two-
                                           dimensional area (polygon) regulated by a municipal
                                           storm sewer system (MS4) NPDES permit through use of
                                           multiple latitude and longitude coordinates. This data
                                           element can also be system generated when the Facility
                                           Site Address, Facility Site City, and Facility Site
                                           State data elements can be used to generate accurate
                                           longitude and latitude values. (Note: ``Post Office
                                           Box'' addresses and ``Rural Route'' addresses are
                                           generally not geocodable)
Facility Contact Affiliation Type         The affiliation of the contact with the facility (e.g.,   122.21, 122.21(j)(6), 122.21(q),         1, 2, 4,
                                           ``Owner,'' ``Operator,'' or ``Main Contact''). This is    122.28(b)(2)(ii), 403.8(f), 403.10,      and 7.
                                           a unique code/description that identifies the nature of   403.12(i), 503.18, 503.28, 503.48
                                           the individual's affiliation to the facility
Facility Contact First Name               The given name of an individual affiliated with this      122.21, 122.21(j)(6), 122.21(q),         1, 2, 4,
                                           facility                                                  122.28(b)(2)(ii), 403.8(f), 403.10,      and 7.
                                                                                                     403.12(i), 503.18, 503.28, 503.48
Facility Contact Last Name                The surname of an individual affiliated with this         122.21, 122.21(j)(6), 122.21(q),         1, 2, 4,
                                           facility                                                  122.28(b)(2)(ii), 403.8(f), 403.10,      and 7.
                                                                                                     403.12(i), 503.18, 503.28, 503.48
Facility Contact Title                    The title held by an individual in an organization        122.21, 122.21(j)(6), 122.21(q),         1, 2, 4,
                                           affiliated with this facility                             122.28(b)(2)(ii), 403.8(f), 403.10,      and 7.
                                                                                                     403.12(i), 503.18, 503.28, 503.48
Facility Contact E-Mail Address           The business e-mail address of the designated individual  122.21, 122.21(j)(6), 122.21(q),         1, 2, 4,
                                           affiliated with this facility                             122.28(b)(2)(ii), 403.8(f), 403.10,      and 7.
                                                                                                     403.12(i), 503.18, 503.28, 503.48
Facility Organization Formal Name         The legal name of the person, firm, public organization,  122.21, 122.21(j)(6), 122.21(q),         1, 2, 4,
                                           or other entity that operates the facility. This name     122.28(b)(2)(ii), 403.8(f), 403.10,      and 7.
                                           may or may not be the same name as the facility. The      403.12(i), 503.18, 503.28, 503.48
                                           operator of the facility is the legal entity that
                                           controls the facility's operation rather than the
                                           facility or site manager. This data element should not
                                           use a colloquial name. This field is optional for MS4
                                           permittees
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                Basic Permit Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
       [Note: As indicated in the ``CWA, Regulatory, or Other Citation'' column, some of these data elements also apply to Significant Industrial Users
   (SIUs) and Categorical Industrial Users (CIUs) that discharge (including non-domestic wastewater delivered by truck, rail, and dedicated pipe or
   other means of transportation) to one or more POTWs and to regulated entities or locations that generate, process, or receive biosolids or sewage
   sludge.]
--------------------------------------------------------------------------------------------------------------------------------------------------------
NPDES ID                                  This is the unique identifier for the NPDES permit or     122.2, 122.21, 122.21(j)(6), 122.21(q),  1, 2, 3, 4,
                                           control mechanism for NPDES regulated entities or         122.28(b)(2)(ii), 122.34(g)(3),          5, 6, 7,
                                           Unpermitted ID for an unpermitted facility. This data     122.41(l)(4)(i), 122.41(l)(6) and (7),   8, 9, 10.
                                           elements is used for compliance monitoring activities,    122.41(m)(3), 122.42(c), 122.42(e)(4),
                                           violation determinations, and enforcement actions. This   123.26, 123.41(a), 125.96, 125.97(g),
                                           data element also applies to Significant Industrial       125.98, 125.138(b), 401.14, 403.10,
                                           Users (SIUs) and Categorical Industrial Users (CIUs)      403.12(e), 403.12(h), 403.12(i),
                                           that discharge (including non-domestic wastewater         503.18, 503.28, 503.48
                                           delivered by truck, rail, and dedicated pipe or other
                                           means of transportation) to one or more POTWs in states
                                           where the POTW is the Control Authority
Master General Permit Number              The unique identifier of the master general permit,       122.2, 122.21, 122.21(j)(6), 122.21(q),  1, 2.
                                           which is linked to a General Permit Covered Facility.     122.28(b)(2)(ii), 122.34(g)(3),
                                           This data element only applies to facilities regulated    122.41(l)(4)(i), 122.41(l)(6) and (7),
                                           by a master general permit                                122.41(m)(3), 122.42(c), 122.42(e)(4),
                                                                                                     123.26, 123.41(a), 403.10, 403.12(e),
                                                                                                     403.12(h), 403.12(i), 503.18, 503.28,
                                                                                                     503.48
Permit Type                               The unique code/description identifying the type of       122.2, 122.21, 122.21(j)(6), 122.21(q),  1, 2.
                                           permit [e.g., NPDES Individual Permit, NPDES Master       122.28(b)(2)(ii), 403.10
                                           General Permit, General Permit Covered Facility, State
                                           Issued Non-NPDES General Permit, Individual IU Permit
                                           (Non-NPDES), Individual State Issued Permit (Non-
                                           NPDES)]
Permit Component                          This will identify one or more applicable NPDES           122.2, 122.21, 122.21(j)(6), 122.21(q),  1, 2.
                                           subprograms (e.g., pretreatment, CAFO, CSO, POTW,         122.28(b)(2)(ii), 403.10
                                           biosolids/sewage sludge, stormwater) for the permit
                                           record. This field is only required when the permit
                                           includes one or more NPDES subprograms
Permit Issue Date                         This is the date the permit was issued. The date must be  122.46                                   1.
                                           provided in YYYY-MM-DD format where YYYY is the year,
                                           MM is the month, and DD is the day
Permit Effective Date                     This is the date on which the permit is effective. The    122.46, 122.21, 122.21(j)(6),            1.
                                           date must be provided in YYYY-MM-DD format where YYYY     122.21(q), 403.10
                                           is the year, MM is the month, and DD is the day
Permit Modification/Amendment Date        This is the date on which the permit was modified or      122.62, 122.63, 403.10                   1.
                                           amended. The date must be provided in YYYY-MM-DD format
                                           where YYYY is the year, MM is the month, and DD is the
                                           day
Permit Expiration Date                    This is the date the permit will expire. The date must    122.46, 122.21, 122.21(j)(6),            1.
                                           be provided in YYYY-MM-DD format where YYYY is the        122.21(q), 403.10
                                           year, MM is the month, and DD is the day
Permit Termination Date                   This is the date the permit was terminated. The date      122.64, 403.10                           1.
                                           must be provided in YYYY-MM-DD format where YYYY is the
                                           year, MM is the month, and DD is the day
Permit Major/Minor Status Indicator       This code/description identifies the permit status as     122.2                                    1.
                                           ``Major'' or ``Nonmajor'' (a.k.a. ``Minor''). This data
                                           element is initially system generated and defaults to
                                           ``Minor''. The most recent permit status is copied when
                                           the permit is reissued
Permit Major/Minor Status Start Date      The date that the permit became its current Major/Minor   122.2                                    1.
                                           status. Initially system-generated to match effective
                                           date. The date must be provided in YYYY-MM-DD format
                                           where YYYY is the year, MM is the month, and DD is the
                                           day
Permit Application Total Design Flow      This is the design flow rate that a permitted facility    122.21, 122.28(b)(2)(ii), 403.10(f)      1, 2.
                                           was designed to accommodate, in millions of gallons per
                                           day (MGD). This is only required for wastewater
                                           treatment plants
Permit Application Total Actual Average   This is the annual average daily flow rate that a         122.21,122.28(b)(2)(ii), 122.41,         1, 2.
 Flow                                      permitted facility will likely accommodate at the start   403.10(f)
                                           of its permit term, in MGD. This is only required for
                                           wastewater treatment plants
Complete Permit Application/NOI Received  This is the date on which the complete application for    122.21, 122.28(b)(2)(ii), 403.10(f)      1.
 Date                                      an individual NPDES permit was received or a complete
                                           Notice of Intent (NOI) for coverage under a master
                                           general permit was received. The date must be provided
                                           in YYYY-MM-DD format where YYYY is the year, MM is the
                                           month, and DD is the day. This data element can be
                                           system generated when the complete NOI is
                                           electronically received by the NPDES program
Permit Application/NOI Received Date      This is the date on which the application for an          122.21, 122.28(b)(2)(ii), 403.10(f)      1.
                                           individual NPDES permit was received or a Notice of
                                           Intent (NOI) for coverage under a master general permit
                                           was received. The date must be provided in YYYY-MM-DD
                                           format where YYYY is the year, MM is the month, and DD
                                           is the day. This data element can be system generated
                                           when the NPDES permit application or NOI is
                                           electronically received by the NPDES program
Permit Status                             This is a unique code/description that identifies the     122.21, 122.21(j)(6), 122.21(q),         1.
                                           permit status (e.g., Effective, Expired,                  122.64, 122.46, 403.10(f)
                                           Administratively Continued, Pending, Not Needed,
                                           Retired, Denied, and Terminated). This is system
                                           generated for all statuses except ``Not Needed,'' which
                                           must be user entered
Master General Permit Industrial          These are the one or more unique codes/descriptions that  122.21, 122.21(j)(6), 122.21(q),         1.
 Category                                  identify the one or more industrial categories covered    122.28(b)(2)(ii), 403.10(f)
                                           by the master general permit. This field is required
                                           for master general permits only
Permit Issuing Organization Type          This is the type of organization issuing a permit (e.g.,  122.21, 122.21(j)(6), 122.21(q),         1.
                                           County, Federal, Local, Municipal, Regional, State,       123.41, 403.10(f)
                                           Tribal)
DMR Non-Receipt                           Turns non-receipt tracking for compliance monitoring      123.45, 403.10(f)                        1.
                                           submissions [e.g., discharge monitoring reports (DMRs)]
                                           ``on'' or ``off'' for non-major permits (a.k.a.
                                           ``minors''). This field is always ``on'' for major
                                           permits. This data element is initially system
                                           generated (defaults to ``on'') and the most recent
                                           value is copied when the permit is reissued. . . . This
                                           data element will also be used to track non-receipt
                                           tracking of periodic compliance monitoring data [40 CFR
                                           403.12(e) and (h)] for Significant Industrial Users
                                           (SIUs) and Categorical Industrial Users (CIUs) that
                                           discharge (including non-domestic wastewater delivered
                                           by truck, rail, and dedicated pipe or other means of
                                           transportation) to one or more POTWs in states where
                                           EPA or the State is the Control Authority)
DMR Non-Receipt Start Date                This is the date on which the permit's ``on'' or ``off''  123.45, 403.10(f)                        1.
                                           period for DMR Non-Receipt tracking status began.
                                           Initially system-generated to match effective date. The
                                           date must be provided in YYYY-MM-DD format where YYYY
                                           is the year, MM is the month, and DD is the day. This
                                           data element will also be used to track non-receipt
                                           tracking of periodic compliance monitoring data [40 CFR
                                           403.12(e) and (h)] for Significant Industrial Users
                                           (SIUs) and Categorical Industrial Users (CIUs) that
                                           discharge (including non-domestic wastewater delivered
                                           by truck, rail, and dedicated pipe or other means of
                                           transportation) to one or more POTWs in states where
                                           EPA or the State is the Control Authority)
Reportable Noncompliance Tracking         Turns reportable noncompliance (RNC) tracking ``on'' or   123.45, 403.10(f)                        1.
                                           ``off'' for non-major permits (a.k.a. ``minors''). This
                                           data element is initially system generated (defaults to
                                           ``on'') and the most recent value is copied when the
                                           permit is reissued
Reportable Noncompliance Tracking Start   This is the date on which the permit's ``on'' or ``off''  123.45, 403.10(f)                        1.
 Date                                      period for Reportable Noncompliance Tracking status
                                           began. Initially system-generated to match effective
                                           date. The date must be provided in YYYY-MM-DD format
                                           where YYYY is the year, MM is the month, and DD is the
                                           day
Applicable Effluent Limitations           The applicable effluent limitations guidelines and new    122.21, 122.21(j)(6), 122.21(q),         1.
 Guidelines                                source performance standards in the NPDES permit (e.g.,   122.44, 403.10(f)
                                           part 414--Organic chemicals, plastics, and synthetic
                                           fibers point source category). This data element also
                                           applies to SIUs and CIUs that discharge (including non-
                                           domestic wastewater delivered by truck, rail, and
                                           dedicated pipe or other means of transportation) to one
                                           or more POTWs in states where the POTW is the Control
                                           Authority
Permit Compliance Tracking Status         This is a unique code/description that indicates whether  122.21, 122.21(j)(6), 122.21(q),         1.
                                           the permit is currently ``on'' or ``off'' for             123.45, 403.10(f)
                                           compliance tracking purposes. This data element is
                                           initially system generated (defaults to ``on'') and the
                                           most recent value is copied when the permit is reissued
Permit Compliance Tracking Status Start   This is the date on which the permit's ``on'' or ``off''  122.21, 122.21(j)(6), 122.21(q),         1.
 Date                                      period for compliance tracking status began. Initially    123.45, 403.10(f)
                                           system-generated to match effective date. The date must
                                           be provided in YYYY-MM-DD format where YYYY is the
                                           year, MM is the month, and DD is the day
RNC Status (Manual)                       The status of reportable noncompliance (RNC) as it was    122.21, 122.21(j)(6), 122.21(q),         1.
                                           entered by the regulatory authority for the official      123.45, 403.10(f)
                                           Quarterly Noncompliance Report (QNCR) or NPDES
                                           Noncompliance Report (NNCR). This data element can also
                                           be revised by the regulatory authority
RNC Status (Manual) Year                  The year associated with the RNC Status (Manual) being    122.21, 122.21(j)(6), 122.21(q),         1.
                                           reported. This data element is used for the official      123.45, 403.10(f)
                                           Quarterly Noncompliance Report (QNCR) or NPDES
                                           Noncompliance Report (NNCR). This data element can also
                                           be revised by the regulatory authority
RNC Status (Manual) Quarter               The quarter associated with the RNC Status (Manual)       122.21, 122.21(j)(6), 122.21(q),         1.
                                           being reported. This data element is used for the         123.45, 403.10(f)
                                           official Quarterly Noncompliance Report (QNCR) or NPDES
                                           Noncompliance Report (NNCR). This data element can also
                                           be revised by the regulatory authority
Associated NPDES ID Number                If applicable, the unique identifier for each NPDES       122.2, 122.21, 122.21(j)(6), 122.21(q),  1 through
                                           Permit that is related to another NPDES Permit. For       122.28(b)(2)(ii), 122.41(l)(4)(i),       5, 7, 8,
                                           example, this data element identifies the recipient       122.41(l)(6) and (7), 122.41(m)(3),      and 9.
                                           POTW's NPDES ID for each satellite collection system,     122.42(e)(4), 123.26, 123.41(a),
                                           the suppliers of biosolids and sewage sludge to a land    503.18, 503.28, 503.48
                                           application site, and the one or more NPDES IDs for
                                           other permitted operators at the same construction site
                                           or industrial facility. This data element does not
                                           apply to municipal storm sewer systems (MS4s) as other
                                           data elements create linkages between these entities
Associated NPDES ID Number Reason         The unique code/description that identifies the reason    122.2, 122.21, 122.21(j)(6), 122.21(q),  1 through
                                           for the association between two NPDES IDs (e.g., ETP =    122.28(b)(2)(ii), 122.41(l)(4)(i),       5, 7, 8,
                                           Effluent Trade Partner, APR = Associated Permit Record,   122.41(l)(6) and (7), 122.41(m)(3),      and 9.
                                           SIP = Switched To An Individual Permit, SGP = Switched    122.42(e)(4), 123.26, 123.41(a),
                                           To A General Permit. This data element does not apply     503.18, 503.28, 503.48
                                           to municipal storm sewer systems (MS4s) as other data
                                           elements create linkages between these entities
Receiving POTW ID                         This data element will identify for each Significant      122.21, 122.21(j)(6)[,]                  1, 2, and
                                           Industrial Users (SIUs) and Categorical Industrial                                                 7.
                                           Users (CIUs) the unique identifier of the one or more
                                           POTWs receiving the discharge. This includes non-
                                           domestic wastewater delivered by truck, rail, and
                                           dedicated pipe or other means of transportation to the
                                           one or more receiving POTWs. This data element only
                                           applies to SIUs and CIUs and will link the industrial
                                           discharger to the one or more receiving POTWs
SIC Code                                  The one or more four-digit Standard Industrial            122.21, 122.21(j)(6), 122.21(q),         1, 2, and
                                           Classification (SIC) codes that represent the economic    122.28(b)(2)(ii), 403.10(f),             7.
                                           activities of the facility. This data element also        403.12(e), 403.12(h), 403.12(i),
                                           applies to SIUs and CIUs that discharge (including non-   503.18, 503.28, 503.48
                                           domestic wastewater delivered by truck, rail, and
                                           dedicated pipe or other means of transportation) to one
                                           or more POTWs in states where the POTW is the Control
                                           Authority. A value of ``4952'' can be system generated
                                           for POTWs and TWTDS
SIC Code Primary Indicator                This data element will identify the primary economic      1, 2, and 7.
                                           activity, SIC code, of the facility. This data element
                                           is required for electronic data transfer between state
                                           and EPA systems. This data element also applies to SIUs
                                           and CIUs that discharge (including non-domestic
                                           wastewater delivered by truck, rail, and dedicated pipe
                                           or other means of transportation) to one or more POTWs
                                           in states where the POTW is the Control
                                           Authority122.21, 122.21(j)(6), 122.21(q),
                                           122.28(b)(2)(ii), 403.10(f), 403.12(e), 403.12(h),
                                           403.12(i), 503.18, 503.28, 503.48
NAICS Code                                The six-digit North American Industry Classification      EPA SIC/NAICS Data Standard, Standard    1, 2, and
                                           System (NAICS) code/description that represents the       No. EX000022.2, 6 January 2006, Office   7.
                                           economic activity of the facility. This field is          of Management and Budget, Executive
                                           optional if the ``SIC Code'' data element is provided     Office of the President, Final
                                           for the facility                                          Decision on North American Industry
                                                                                                     Classification System (62 FR 17288),
                                                                                                     403.10(f)
NAICS Code Primary Indicator              This data element will identify the primary economic      EPA SIC/NAICS Data Standard, Standard    1, 2, and
                                           activity, NAICS code, of the facility. This data          No. EX000022.2, 6 January 2006, Office   7.
                                           element is required for electronic data transfer          of Management and Budget, Executive
                                           between state and EPA systems. This field is optional     Office of the President, Final
                                           if the ``SIC Code'' data element is provided for the      Decision on North American Industry
                                           facility                                                  Classification System (62 FR 17288),
                                                                                                     403.10(f)
Permittee Mailing Address                 The mailing address of the permit holder                  122.21, 122.21(j)(6), 122.21(q),         1, 2.
                                                                                                     122.28(b)(2)(ii), 403.10(f)
Permittee Organization Formal Name        The legal, formal name of the organization that holds     122.21, 122.21(j)(6), 122.21(q),         1, 2.
                                           the permit                                                122.28(b)(2)(ii), 403.10(f)
Permittee City                            The name of the city, town, or village where the mail is  122.21, 122.21(j)(6), 122.21(q),         1, 2.
                                           delivered for the permit holder                           122.28(b)(2)(ii), 403.10(f)
Permittee State                           The U.S. Postal Service abbreviation that represents the  122.21, 122.21(j)(6), 122.21(q),         1, 2.
                                           state or state equivalent for the U.S. for the permit     122.28(b)(2)(ii), 403.10(f)
                                           holder
Permittee Zip Code                        The combination of the 5-digit Zone Improvement Plan      122.21, 122.21(j)(6), 122.21(q),         1, 2.
                                           (ZIP) code and the 4-digit extension code (if             122.28(b)(2)(ii), 403.10(f)
                                           available) that represents the geographic segment that
                                           is a sub-unit of the ZIP Code assigned by the U.S.
                                           Postal Service to a geographic location for the permit
                                           holder
Residual Designation Determination Code   Under section 402(p)(2)(E) and (6) and 40 CFR             122.26(a)(9)(i)(C) and (D) and CWA       1.
                                           122.26(a)(9)(i)(C) and (D), the authorized NPDES          section 402(p)
                                           program or the EPA Regional Administrator may
                                           specifically designate stormwater discharges as
                                           requiring an NPDES permit. In this `residual
                                           designation' process the NPDES permitting authority
                                           regulates stormwater discharges based on: (1) Wasteload
                                           allocations that are part of ``total maximum daily
                                           loads'' (TMDLs) that address the pollutant(s) of
                                           concern in the stormwater discharges [see 40 CFR
                                           122.26(a)(9)(i)(C)]; or (2) the determination that the
                                           stormwater discharge, or category of stormwater
                                           discharges within a geographic area, contributes to a
                                           violation of a water quality standard or is a
                                           significant contributor of pollutants to waters of the
                                           United States [see 40 CFR 122.26(a)(9)(i)(D)]. This
                                           data element is the unique code/description that
                                           identifies the main basis for this residual designation
                                           determination. This data element only applies to
                                           stormwater permits
Electronic Reporting Waiver Type          The unique code/description that identifies whether the   123.26, 123.41(a) and CWA section 308    1.
                                           authorized NPDES program has granted the permittee a
                                           waiver from electronic reporting in compliance with
                                           this part (1 = temporary waiver; 2 = permanent waiver).
                                           This data element should be left blank if the permittee
                                           does not have a waiver from electronic reporting in
                                           compliance with this part
Electronic Reporting Waiver Expiration    This is the expiration date for a temporary waiver from   123.26, 123.41(a) and CWA section 308    1.
 Date                                      electronic reporting in compliance with this part. This
                                           data element should be left blank if the permittee has
                                           a permanent waiver from electronic reporting or if the
                                           permittee does not have a waiver from electronic
                                           reporting in compliance with this part
Electronic Submission Type (General       This is the unique code/description for each general      123.26, 123.41(a) and CWA section 308    1.
 Permit Reports)                           permit report submitted by the facility or entity.
                                           Notices, certifications, and waiver requests covered by
                                           this data element are listed in Table 1 in this
                                           appendix (i.e., NPDES Data Group 2). This data element
                                           describes how each submission was electronically
                                           collected or processed by the initial recipient [see 
                                           127.2(b)]. For example, these unique codes/descriptions
                                           include: (1) NPDES regulated entity submits NPDES
                                           program data using an EPA electronic reporting system;
                                           (2) NPDES regulated entity submits NPDES program data
                                           using an authorized NPDES program electronic reporting
                                           system; (3) NPDES regulated entity has temporary waiver
                                           from electronic reporting and submits NPDES program
                                           data on paper to the authorized NPDES program who then
                                           electronically uses manual data entry to electronically
                                           process these data; (4) NPDES regulated entity has a
                                           permanent waiver from electronic reporting and submits
                                           NPDES program data on paper to the authorized NPDES
                                           program who then electronically uses manual data entry
                                           to electronically process these data; (5) NPDES
                                           regulated entity has an episodic waiver from electronic
                                           reporting and submits NPDES program data on paper to
                                           the authorized NPDES program who then electronically
                                           uses manual data entry to electronically process these
                                           data; (6) NPDES regulated entity submits NPDES program
                                           data on paper in a form that allows the authorized
                                           NPDES program to use of automatic identification and
                                           data capture technology to electronically process these
                                           data; (7) NPDES regulated entity submits NPDES program
                                           data using another electronic reporting system (e.g.,
                                           third-party). This data element can sometimes be system
                                           generated (e.g., incorporated into an electronic
                                           reporting tool). This data element does not identify
                                           the electronic submission type of other reports (NPDES
                                           Data Groups = 3 through 10 in Table 1), which is
                                           tracked by the ``Electronic Submission Type (Compliance
                                           Monitoring Activity)'' data element
NPDES Data Group Number                   This is the unique code/description that identifies the   122.2, 122.21, 122.21(j)(6), 122.21(q),  1.
                                           types of NPDES program data that are required to be       122.28(b)(2)(ii), 122.34(g)(3),
                                           reported by the facility. This corresponds to Table 1     122.41(l)(4)(i), 122.41(l)(6) and (7),
                                           in this appendix (e.g., 3 = Discharge Monitoring Report   122.41(m)(3), 122.42(c), 122.42(e)(4),
                                           [40 CFR 122.41(l)(4)]). This data element can be system   123.26, 123.41(a), 403.10, 403.12(e),
                                           generated. This data element will record each NPDES       403.12(h), 403.12(i), 503.18, 503.28,
                                           Data Group that the facility is required to submit. For   503.48 and CWA section 308
                                           example, when a POTW is required to submit a Discharge
                                           Monitoring Report, Sewage Sludge/Biosolids Annual
                                           Program Report, Pretreatment Program Report, and Sewer
                                           Overflow/Bypass Event Report, the values for this data
                                           element for this facility will be 3, 4, 7, and 9. The
                                           following general permit reports will have the
                                           following values for this data element: 2a = Notice of
                                           Intent to discharge (NOI); 2b = Notice of Termination
                                           (NOT); 2c = No Exposure Certification (NOE); and 2d =
                                           Low Erosivity Waiver or Other Waiver from stormwater
                                           Controls (LEW)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                  Narrative Conditions and Permit Schedules Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
      [Note: As indicated in the ``CWA, Regulatory, or Other Citation'' column, these data elements also apply to Significant Industrial Users (SIUs)
   and Categorical Industrial Users (CIUs) that discharge (including non-domestic wastewater delivered by truck, rail, and dedicated pipe or other means
   of transportation) to one or more POTWs in states where EPA or the State is the Control Authority].
--------------------------------------------------------------------------------------------------------------------------------------------------------
Permit Narrative Condition Code           The unique code/description that identifies the type of   122.47, 403.10(f)                        1.
                                           narrative condition
Permit Narrative Condition Number         This number uniquely identifies a narrative condition     122.47, 403.10(f)                        1.
                                           and its elements for a permit
Permit Schedule Date                      The date on which a permit schedule event is due to be    122.47, 403.10(f)                        1.
                                           completed and against which compliance will be
                                           measured. The date must be provided in YYYY-MM-DD
                                           format where YYYY is the year, MM is the month, and DD
                                           is the day
Permit Schedule Actual Date               The date on which the permittee achieved the schedule     122.47, 403.10(f)                        1.
                                           event. The date must be provided in YYYY-MM-DD format
                                           where YYYY is the year, MM is the month, and DD is the
                                           day
Required Report Received Date             The date on which the regulatory authority receives a     122.47, 403.10(f)                        1.
                                           report from the permittee indicating that a scheduled
                                           event was completed (e.g., the start of construction)
                                           or the date on which the regulatory authority received
                                           the required report. The date must be provided in YYYY-
                                           MM-DD format where YYYY is the year, MM is the month,
                                           and DD is the day
Permit Schedule Event Code                The unique code/description indicating the one or more    122.47, 403.10(f)                        1.
                                           events with which the permittee is scheduled to comply
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Permitted Feature Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
      [Note: These `Permitted Feature' data elements are only required to be submitted for permits that require limits or outfall monitoring for
   stationary point sources. Additionally, as indicated in the ``CWA, Regulatory, or Other Citation'' column, some of these data elements apply to
   Significant Industrial Users (SIUs) and Categorical Industrial Users (CIUs) that discharge (including non-domestic wastewater delivered by truck,
   rail, and dedicated pipe or other means of transportation) to one or more POTWs in states where EPA or the State is the Control Authority].
--------------------------------------------------------------------------------------------------------------------------------------------------------
Permitted Feature Application Actual      The average flow that a permitted feature will actually   122.21, 122.28(b)(2)(ii), 403.10(f)      1, 2.
 Average Flow (MGD)                        discharge or transmit, in MGD, at the start of its
                                           permit term. This data element does not apply to
                                           regulated entities that do not discharge (e.g., some
                                           biosolids/sewage sludge generators) and entities that
                                           only discharge stormwater. This data element may also
                                           not apply to some intermittent dischargers
Permitted Feature Identifier (Permit)     The identifier assigned for each location at which        122.21, 122.28(b)(2)(ii), 403.10(f)      1, 2.
                                           conditions are being applied (e.g., external outfall).
                                           This data element also identifies cooling water intake
                                           structures
Permitted Feature Type                    The code/description that uniquely identifies the type    122.21, 122.28(b)(2)(ii), 403.10(f)      1, 2.
                                           of permitted feature (e.g.[,] external outfall, sum,
                                           intake structure, cooling water intake structure)
Receiving Waterbody Name for Permitted    The name of the waterbody that is or will likely receive  122.21, 122.28(b)(2)(ii)                 1, 2.
 Feature                                   the discharge from each permitted feature
Permitted Feature Longitude               The measure of the angular distance on a meridian east    122.21, 122.28(b)(2)(ii)                 1, 2.
                                           or west of the prime meridian for the permitted
                                           feature. The format for this data element is decimal
                                           degrees (e.g., ^77.029289) and the WGS84 standard
                                           coordinate system
Permitted Feature Latitude                The measure of the angular distance on a meridian north   122.21, 122.28(b)(2)(ii)                 1, 2.
                                           or south of the equator for the permitted feature. The
                                           format for this data element is decimal degrees (e.g.,
                                           38.893829) and the WGS84 standard coordinate system
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Limit Set Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
      [Note: These `Limit Set' data elements are only required to be submitted for permits that require limits or outfall monitoring for stationary
   point sources. Additionally, as indicated in the ``CWA, Regulatory, or Other Citation'' column, these data elements apply to Significant Industrial
   Users (SIUs) and Categorical Industrial Users (CIUs) that discharge (including non-domestic wastewater delivered by truck, rail, and dedicated pipe
   or other means of transportation) to one or more POTWs in states where EPA or the State is the Control Authority].
--------------------------------------------------------------------------------------------------------------------------------------------------------
Limit Set Designator                      The alphanumeric field that is used to designate a        122.45, 403.10(f)                        1.
                                           particular grouping of parameters within a limit set
Limit Set Type                            The unique code/description identifying the type of       122.45, 403.10(f)                        1.
                                           limit set (e.g., scheduled, unscheduled)
Modification Effective Date (Limit Set)   The effective date of the permit modification that        122.45, 403.10(f)                        1.
                                           updated or created a limit set. The date must be
                                           provided in YYYY-MM-DD format where YYYY is the year,
                                           MM is the month, and DD is the day
Modification Type (Limit Set)             The type of permit modification that updated or created   122.45, 403.10(f)                        1.
                                           this limit set (e.g., major modification, minor
                                           modification, permit authorized change)
Initial Monitoring Date                   The date on which monitoring starts for the first         122.45, 403.10(f)                        1.
                                           monitoring period for the limit set. This date will be
                                           blank for unscheduled limit sets. The date must be
                                           provided in YYYY-MM-DD format where YYYY is the year,
                                           MM is the month, and DD is the day
Initial DMR Due Date                      The date that the first compliance monitoring submission  122.45, 403.10(f)                        1.
                                           (e.g., DMR) for the limit set is due to the regulatory
                                           authority. This date will be blank for unscheduled
                                           limit sets. The date must be provided in YYYY-MM-DD
                                           format where YYYY is the year, MM is the month, and DD
                                           is the day. This data element will also be used to
                                           track non-receipt tracking of periodic compliance
                                           monitoring data [40 CFR 403.12(e) and (h)] for
                                           Significant Industrial Users (SIUs) and Categorical
                                           Industrial Users (CIUs) that discharge (including non-
                                           domestic wastewater delivered by truck, rail, and
                                           dedicated pipe or other means of transportation) to one
                                           or more POTWs in states where EPA or the State is the
                                           Control Authority)
Number of Report Units                    The number of months covered in each compliance           122.45, 403.10(f)                        1.
                                           monitoring period (e.g., monthly = 1, semi-annually =
                                           6, quarterly = 3)
Number of Submission Units                The number of months between compliance monitoring        122.45, 403.10(f)                        1.
                                           submissions (e.g., monthly = 1, semi-annually = 6,
                                           quarterly = 3). This data element will be blank for
                                           unscheduled limit sets For example, if the permittee
                                           was required to submit monthly reports every quarter,
                                           the number of report units would be one (i.e., monthly)
                                           and the number of submission units would be three
                                           (i.e., three months of information in each submission).
Limit Set Status                          The status of the limit set (e.g., active, inactive).     subpart C of 122, 403.10(f)              1.
                                           Limit sets will not have violations generated when a
                                           limit set is inactive unless an enforcement action
                                           limit is present
Limit Set Status Start Date               The date that the Limit Set Status started. The date      123.45, 403.10(f)                        1.
                                           must be provided in YYYY-MM-DD format where YYYY is the
                                           year, MM is the month, and DD is the day
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                                                                    Limit Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
      [Note: These `Limit' data elements are only required to be submitted for permits that require limits or outfall monitoring for stationary point
   sources. Additionally, as indicated in the ``CWA, Regulatory, or Other Citation'' column, some of these data elements apply to Significant Industrial
   Users (SIUs) and Categorical Industrial Users (CIUs) that discharge (including non-domestic wastewater delivered by truck, rail, and dedicated pipe
   or other means of transportation) to one or more POTWs in states where EPA or the State is the Control Authority].
--------------------------------------------------------------------------------------------------------------------------------------------------------
Monitoring Location Code                  The unique code/description of the monitoring location    122.45, 403.10(f)                        1.
                                           at which sampling should occur for a limit parameter
Limit Season Number                       Indicates the season of a limit and is used to enter      122.45, 403.10(f)                        1.
                                           different seasonal limits for the same parameter within
                                           a single limit start and end date
Limit Start Date                          The date on which a limit starts being in effect for a    122.45, 403.10(f)                        1.
                                           particular parameter in a limit set. The date must be
                                           provided in YYYY-MM-DD format where YYYY is the year,
                                           MM is the month, and DD is the day
Limit End Date                            The date on which a limit stops being in effect for a     122.45, 403.10(f)                        1.
                                           particular parameter in a limit set. The date must be
                                           provided in YYYY-MM-DD format where YYYY is the year,
                                           MM is the month, and DD is the day
Change of Limit Status Indicator          The unique code/description that describes circumstances  subpart C of 122, 403.10(f)              1.
                                           affecting limits, such as formal enforcement actions or
                                           permit modifications
Limit Stay Type                           The unique identifier of the type of stay applied to a    122.45, 403.10(f)                        1.
                                           limit (e.g., X, Y, Z), which indicates whether the
                                           limits do not appear on the compliance monitoring
                                           report (e.g., DMR) at all, are treated as monitor only,
                                           or have a stay value in effect during the period of the
                                           stay
Limit Stay Start Date                     The date on which a limit stay begins. The date must be   124.19, 403.10(f)                        1.
                                           provided in YYYY-MM-DD format where YYYY is the year,
                                           MM is the month, and DD is the day
Limit Stay End Date                       The date on which a limit stay is lifted. The date must   124.19, 403.10(f)                        1.
                                           be provided in YYYY-MM-DD format where YYYY is the
                                           year, MM is the month, and DD is the day
Reason for Limit Stay                     The text that represents the reason a stay was applied    124.19, 403.10(f)                        1.
                                           to a permit
Stay Limit Value                          The numeric limit value imposed during the period of the  124.19, 403.10(f)                        1.
                                           stay for the limit; if entered, during the stay period,
                                           the system will use this limit value for calculating
                                           compliance, rather than the actual limit value that was
                                           stayed
Limit Type                                The unique code/description that indicates whether a      122.45, 403.10(f)                        1.
                                           limit is an enforceable, or alert limit (e.g., action
                                           level, benchmark) that does not receive effluent
                                           violations
Enforcement Action ID                     The unique identifier for the enforcement action that     122.45, 403.10(f)                        1.
                                           imposed the enforcement action limit; this data element
                                           helps uniquely tie the limit record to the final order
                                           record
Final Order ID                            The unique identifier for the Final Order that imposed    122.45, 403.10(f)                        1.
                                           the Enforcement Action limit; this data element ties
                                           the limit record to the Final Order record in the
                                           database
Modification Effective Date               The effective date of the permit modification that        122.62, 403.10(f)                        1.
                                           created this limit. The date must be provided in YYYY-
                                           MM-DD format where YYYY is the year, MM is the month,
                                           and DD is the day
Modification Type                         The type of permit modification that created this limit   122.62, 403.10(f)                        1.
                                           (e.g., major, minor, permit authorized change)
Limit Parameter Code                      The unique code/description identifying the parameter     122.41(j), 403.10(f)                     1.
                                           being limited and/or monitored
Limit Months                              The months that the limit applies                         122.46, 403.10(f)                        1.
Limit Value Type                          The indication of the limit value type (e.g., Quantity    122.45(f), 403.10(f)                     1.
                                           1, Concentration 2)
Limit Quantity or Concentration Units     The unique code/description representing the unit(s) of   122.45(f), 403.10(f)                     1.
                                           measure applicable to quantity or concentration limits
                                           as entered by the user
Statistical Base Code                     The unique code/description representing the unit of      122.45(d), 403.10(f)                     1.
                                           measure applicable to the limit and compliance
                                           monitoring activity (e.g., DMR) values entered by the
                                           user (e.g., 30-day average, daily maximum)
Optional Monitoring Code                  The code/description that indicates when monitoring is    122.45, 403.10(f)                        1.
                                           optional but not required (e.g., DMR Non-Receipt
                                           violation generation will be suppressed for optional
                                           monitoring)
Limit Value Qualifier                     The unique code identifying the limit value operator      122.45, 403.10(f)                        1.
                                           (e.g., ``<'', ``='', ``>'')
Limit Value                               The actual limit value number from the Permit or          122.45, 403.10(f)                        1.
                                           Enforcement Action Final Order
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                                   Sewage Sludge/Biosolids Information on NPDES Permit Application or Notice of Intent
--------------------------------------------------------------------------------------------------------------------------------------------------------
       [Note: As indicated in the ``CWA, Regulatory, or Other Citation'' column, these data elements apply to Treatment Works Treating Domestic Sewage
   whose sewage sludge use or disposal practices are regulated by part 503.]
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Biosolids/Sewage Sludge Management        The unique code/description that identifies whether the   122.21(q), 122.28(b)(2)(ii), 503.18,     1, 2, and
 Facility Type                             facility was issued a permit as a biosolids/sewage        503.28, 503.48                           4.
                                           sludge generator, processor, or end user (e.g., land
                                           application site, surface disposal site, incinerator).
                                           For the Sewage Sludge/Biosolids Annual Report this data
                                           element is also the unique code/description that
                                           identifies an off-site facility or location receives
                                           biosolids or sewage sludge from this facility. This
                                           data element is also required for the Sewage Sludge/
                                           Biosolids Annual Report
Biosolids or Sewage Sludge Treatment      The one or more unique codes/descriptions that            122.21(q)(6), 122.28(b)(2)(ii)           1, 2.
 Processes (Permit)                        identifies the biosolids or sewage sludge treatment
                                           process or processes at the facility. For example, this
                                           may include treatment processes in the following
                                           categories: preliminary operations (e.g., sludge
                                           grinding and degritting), thickening (concentration),
                                           stabilization, anaerobic digestion, aerobic digestion,
                                           composting, conditioning, disinfection (e.g., beta ray
                                           irradiation, gamma ray irradiation, pasteurization),
                                           dewatering (e.g., centrifugation, sludge drying beds,
                                           sludge lagoons), heat drying, thermal reduction, and
                                           methane or biogas capture and recovery
Biosolids or Sewage Sludge Form (Permit)  The one or more unique codes/descriptions that identify   122.21(q)(6), 122.28(b)(2)(ii)           1, 2.
                                           the nature of each biosolids and sewage sludge material
                                           generated by the facility in terms of whether the
                                           material is a biosolid or sewage sludge and whether the
                                           material is ultimately conveyed off-site in bulk or in
                                           bags. The facility will separately report the form for
                                           each biosolids or sewage sludge management practice and
                                           pathogen class
Biosolids or Sewage Sludge Management     The one or more unique codes/descriptions that identify   122.21(q)(6), 122.28(b)(2)(ii)           1, 2.
 Practice (Permit)                         the type of biosolids or sewage sludge management
                                           practice or practices (e.g., land application, surface
                                           disposal, incineration) used by the facility. The
                                           facility will separately report the practice for each
                                           different form of biosolids and sewage sludge generated
                                           by the facility and pathogen class
Biosolids or Sewage Sludge Pathogen       The one or more unique codes/descriptions that identify   122.21(q)(6), 122.28(b)(2)(ii)           1, 2.
 Class (Permit)                            the pathogen class or classes (e.g., Class A, Class B,
                                           Not Applicable) for biosolids or sewage sludge
                                           generated by the facility. The facility will separately
                                           report the pathogen class for each biosolids or sewage
                                           sludge management practice used by the facility and for
                                           each biosolids or sewage sludge form
Biosolids or Sewage Sludge Vector         The one or more unique codes/descriptions that identify   122.21(q)(6), 122.28(b)(2)(ii)           1, 2.
 Attraction Reduction Options (Permit)     the option(s) used by the facility for vector
                                           attraction reduction. See a listing of these vector
                                           attraction reduction options at 40 CFR 503.33(b)(1)
                                           through (11). The facility will separately report the
                                           vector attraction reduction options for each biosolids
                                           or sewage sludge management practice used by the
                                           facility and for each biosolids or sewage sludge form
                                           as well as by each biosolids or sewage sludge pathogen
                                           class
Biosolids or Sewage Sludge Pathogen       The one or more unique codes/descriptions that identify   122.21(q)(6), 122.28(b)(2)(ii)           1, 2.
 Reduction Options (Permit)                the option(s) used by the facility to control pathogens
                                           (e.g., Class A--Alternative 1, Class A--Alternative 2,
                                           Class A--Alternative 3, Class A--Alternative 4, Class
                                           A--Alternative 5, Class A--Alternative 6, Class B--
                                           Alternative 1, Class B--Alternative 2, Class B--
                                           Alternative 3, or pH Adjustment (Domestic Septage). The
                                           facility will separately report the pathogen reduction
                                           options for each biosolids or sewage sludge management
                                           practice used by the facility and by each biosolids or
                                           sewage sludge form as well as by each biosolids or
                                           sewage sludge pathogen class
Biosolids or Sewage Sludge Amount         This is the amount (in dry metric tons) of biosolids or   122.21 (q), 122.28(b)(2)(ii)             1, 2.
 (Permit)                                  sewage sludge applied to the land, prepared for sale or
                                           give-away in a bag or other container for application
                                           to the land, or placed on an active sewage sludge unit
                                           in the preceding 365-day period. This identification
                                           will be made for each biosolids or sewage sludge
                                           management practice used by the facility and by each
                                           biosolids or sewage sludge form as well as by each
                                           biosolids or sewage sludge pathogen class
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                                  Animal Feeding Operation Information on NPDES Permit Application or Notice of Intent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Facility CAAP Designation                 A unique code (e.g., ``Yes'', ``No'') to indicate         122.21(i)(2), 122.24, 122.25,            1, 2.
                                           whether the facility includes Concentrated Aquatic        122.28(b)(2)(ii)
                                           Animal Production (CAAP)
Facility CAFO Type                        The unique code/description that identifies whether the   122.21(i)(1), 122.23, 122.28(b)(2)(ii)   1, 2.
                                           facility includes a small, medium or large Concentrated
                                           Animal Feeding Operation (CAFO)
CAFO Designation Date                     The date on which the facility is designated as a small   122.23                                   1.
                                           or medium Concentrated Animal Feeding Operation (CAFO).
                                           The date must be provided in YYYY-MM-DD format where
                                           YYYY is the year, MM is the month, and DD is the day
CAFO Designation Reason                   The reason(s) the State Director or the Regional          122.23(c)                                1.
                                           Administrator used to designate an animal feeding
                                           operation as a small or medium CAFO. [Ed note: Large
                                           and medium CAFO definitions are in 40 CFR 122.23(b)].
                                           This text field can include the following factors: (1)
                                           the size of the AFO and the amount of wastes reaching
                                           waters of the United States; (2) the location of the
                                           AFO relative to waters of the United States; (3) the
                                           means of conveyance of animal wastes and process waste
                                           waters into waters of the United States; (4) the slope,
                                           vegetation, rainfall, and other factors affecting the
                                           likelihood or frequency of discharge of animal wastes
                                           manure and process waste waters into waters of the
                                           United States; and (5) other relevant factors
CAFO Animal Types                         The unique code/description that identifies the animal    122.21(i)(1)(v), 122.28(b)(2)(ii)        1, 2.
                                           type(s) at the facility (e.g., beef cattle, broilers,
                                           layers, swine weighing 55 pounds or more, swine
                                           weighing less than 55 pounds, mature dairy cows, dairy
                                           heifers, veal calves, sheep and lambs, horses, ducks,
                                           turkeys, other)
CAFO Animal Maximum Numbers               The estimated maximum number of each type of animal in    122.21(i)(1)(v), 122.28(b)(2)(ii)        1, 2.
                                           open confinement or housed under roof (either partially
                                           or totally) which are held at the facility for a total
                                           of 45 days or more in a 12 month period
CAFO Animal Maximum Numbers in Open       The estimated maximum number of each type of animal in    122.21(i)(1)(v), 122.28(b)(2)(ii)        1, 2.
 Confinement                               open confinement which are held at the facility for a
                                           total of 45 days or more in a 12 month period
CAFO MLPW                                 The unique code/description that identifies the type of   122.21(i)(1)(viii), 122.28(b)(2)(ii)     1, 2.
                                           CAFO manure, litter, and process wastewater generated
                                           by the facility i.e., in a 12 month period
CAFO MLPW Amounts                         The estimated amount of CAFO manure, litter, and process  122.21(i)(1)(viii), 122.28(b)(2)(ii)     1, 2.
                                           wastewater generated by the facility i.e., in a 12
                                           month period
CAFO MLPW Amounts Units                   The unit (e.g., tons, gallons) for the estimated maximum  122.21(i)(1)(viii), 122.28(b)(2)(ii)     1, 2.
                                           amount of CAFO manure, litter, and process wastewater
                                           generated by the facility i.e., in a 12 month period
CAFO MLPW Transferred                     The estimated maximum amount of CAFO manure, litter, and  122.21(i)(1)(ix), 122.28(b)(2)(ii)       1, 2.
                                           process wastewater generated by the facility i.e., in a
                                           12 month period that is transferred to other persons.
                                           The units for this data element will be the same as the
                                           units for the ``CAFO MLPW Amounts'' data element
Total Number of Acres Available for Land  Total number of acres under the control of the applicant  122.21(i)(1)(vii), 122.28(b)(2)(ii)      1, 2.
 Application                               that are available for land application of CAFO manure,
                                           litter, and process wastewater
CAFO MLPW Containment and Storage Type    The unique code/description describing the one or more    122.21(i)(1)(vi), 122.28(b)(2)(ii)       1, 2.
                                           types of CAFO manure, litter, and process wastewater
                                           containment and storage (e.g., lagoon, holding pond,
                                           evaporation pond, anaerobic lagoon, storage lagoon,
                                           evaporation pond, aboveground storage tanks,
                                           belowground storage tanks, roofed storage shed,
                                           concrete pad, impervious soil pad, other) at the
                                           facility
CAFO MLPW Containment and Storage         The estimated maximum capacity of each CAFO manure,       122.21(i)(1)(vi), 122.28(b)(2)(ii)       1, 2.
 Maximum Capacity Amounts                  litter, and process wastewater containment and storage
                                           type at the facility
CAFO MLPW Containment and Storage         The unit for the estimated maximum capacity of each CAFO  122.21(i)(1)(vi), 122.28(b)(2)(ii)       1, 2.
 Maximum Capacity Amounts Unit             manure, litter, and process wastewater containment and
                                           storage type at the facility (e.g., gallons)
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 Construction and Industrial Stormwater Information [from the permitting authority derived from the No Exposure Certification, Low Erosivity Waiver, and
                                      Other Waiver From Stormwater Controls (see Exhibit 1 to 40 CFR 122.26(b)(15)]
--------------------------------------------------------------------------------------------------------------------------------------------------------
No Exposure Certification Approval Date   This is the date on which the No Exposure Certification   122.26(g)                                1.
                                           (NOE) was authorized by the NPDES permitting authority.
                                           Submission of a No Exposure Certification means that
                                           the facility does not require NPDES permit
                                           authorization for its stormwater discharges due to the
                                           existence of a condition of ``no exposure.'' A
                                           condition of no exposure exists at an industrial
                                           facility when all industrial materials and activities
                                           are protected by a storm resistant shelter to prevent
                                           exposure to rain, snow, snowmelt, and/or runoff and the
                                           operator complies with all requirements at 40 CFR
                                           122.26(g)(1) through (4). This date is provided by the
                                           permitting authority. The date must be provided in YYYY-
                                           MM-DD format where YYYY is the year, MM is the month,
                                           and DD is the day
Low Erosivity Waiver or Other Waiver      The NPDES Stormwater Phase II Rule allows NPDES           Exhibit 1 to 40 CFR 122.26(b)(15)        1.
 From Stormwater Controls Approval Date    permitting authorities to accept low erosivity waivers
                                           and other waivers from stormwater controls (LEWs) for
                                           small construction sites. The waiver process exempts
                                           small construction sites (disturbing under five acres)
                                           from NPDES permitting requirements when the rainfall
                                           erosivity factor is less than five during the period of
                                           construction activity as well as other criteria [see
                                           Exhibit 1 to 40 CFR 122.26(b)(15)]. This is the date
                                           when the NPDES permitting authority granted such
                                           waiver, based on information from the entity requesting
                                           the waiver; this date is provided by the permitting
                                           authority. The date must be provided in YYYY-MM-DD
                                           format, where YYYY is the year, MM is the month, and DD
                                           is the day
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 Construction Stormwater Information on NPDES Permit Application, Notice of Intent, or Waiver Request [including construction activity requiring permit
                                                         coverage under 40 CFR 122.26(b)(14)(x)]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Area of the Site                    This is an estimate of the total area of the              122.26(c)(1)(ii)(B)                      1.
                                           construction site at the time of permit application (in
                                           acres). This data element is only required for
                                           individual construction stormwater permit applications.
                                           Values under 5 acres will be reported to the nearest \1/
                                           10\ of an acre or nearest \1/4\ acre. Authorized NPDES
                                           programs will have the discretion to choose whether
                                           permittees should report to the nearest \1/10\ of an
                                           acre or nearest \1/4\ acre for values under 5 acres
Total Activity Area (Construction)        This is the estimate of the total area of the             122.26, 122.28(b)(2)(ii)                 1, 2.
                                           construction activities at the time of permit
                                           application or filing of notice of intent to be covered
                                           under a general permit (in acres). Areas of
                                           construction activity include areas of clearing,
                                           grading, and/or excavation and areas of construction
                                           support activity (e.g., concrete or asphalt batch
                                           plants, equipment staging yards, material storage
                                           areas, excavated materials disposal areas, borrow
                                           areas). Values under 5 acres will be reported to the
                                           nearest \1/10\ of an acre or nearest \1/4\ acre.
                                           Authorized NPDES programs will have the discretion to
                                           choose whether permittees should report to the nearest
                                           \1/10\ of an acre or nearest \1/4\ acre for values
                                           under 5 acres
Post-Construction Total Impervious Area   This is the estimate of total impervious area of the      122.26(c)(1)(ii)(E)                      1.
                                           site after the construction addressed in the permit
                                           application is completed (in acres). This estimate is
                                           made at the time of the permit application. This data
                                           element is only required for individual construction
                                           stormwater permit applications. Values under 5 acres
                                           will be reported to the nearest \1/10\ of an acre or
                                           nearest \1/4\ acre. Authorized NPDES programs will have
                                           the discretion to choose whether permittees should
                                           report to the nearest \1/10\ of an acre or nearest \1/
                                           4\ acre for values under 5 acres
Proposed Stormwater Best Management       This is the one or more unique codes that list the most   122.26(c)(1)(ii)(C)                      1.
 Practices for Construction Activities     important proposed measures, including best management
                                           practices, to control pollutants in stormwater
                                           discharges from construction activities. This data
                                           element includes temporary structural measures (e.g.,
                                           check dams, construction road stabilization, silt
                                           fences), vegetative measures (e.g., mulching, seeding,
                                           sodding, straw/hay bale dikes), and permanent
                                           structures (e.g., land grading, riprap slope
                                           protection, streambank protection). This data element
                                           field is only required for individual construction
                                           stormwater permit applications
Post-Construction Stormwater Best         This is the one or more unique codes that list the most   122.26(c)(1)(ii)(D)                      1.
 Management Practices for Construction     important proposed long-term measures and permanent
 Activities                                structures to control pollutants in stormwater
                                           discharges, which will occur after the completion of
                                           construction operations. The codes for this data
                                           element include long-term control measures (e.g.,
                                           cleaning and removal of debris after major storm
                                           events, harvesting vegetation when a 50 percent
                                           reduction in the original open water surface area
                                           occurs, sediment cleanout, repairing embankments, side
                                           slopes, and control structures) and permanent
                                           structures (e.g., land grading, riprap slope
                                           protection, streambank protection, ponds, wetlands,
                                           infiltration basins, sand filters, filter strips). This
                                           data element is only required for individual
                                           construction stormwater permit applications
Soil and Fill Material Description        This is a text field describes the nature of fill         122.26(c)(1)(ii)(E)                      1.
                                           material and existing data describing soils or the
                                           quality of the discharge. This data element is only
                                           required for individual construction stormwater permit
                                           applications
Runoff Coefficient of the Site (Post-     This is an estimate of the overall runoff coefficient of  122.26(c)(1)(ii)(E)                      1.
 Construction)                             the site after the construction addressed in the permit
                                           application is completed. This data element is only
                                           required for individual construction stormwater permit
                                           applications
Estimated Construction Project Start      The estimated start date for the construction project     122.26, 122.28(b)(2)(ii)                 1, 2.
 Date                                      covered by the NPDES permit. The date must be provided
                                           in YYYY-MM-DD format where YYYY is the year, MM is the
                                           month, and DD is the day
Estimated Construction Project End Date   The estimated end date for the construction project       122.26, 122.28(b)(2)(ii)                 1, 2.
                                           covered by the NPDES permit. The date must be provided
                                           in YYYY-MM-DD format where YYYY is the year, MM is the
                                           month, and DD is the day
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 Industrial Stormwater Information on NPDES Permit Application [excluding construction activity requiring permit coverage under 40 CFR 122.26(b)(14)(x)]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total Surface Area Drained (Industrial)   This is an estimate of the total surface area drained at  122.26(c)(1)(i)(B)                       1.
                                           the facility at the time of permit application (in
                                           acres). This data field is only required for individual
                                           industrial stormwater permit applications. Values under
                                           5 acres will be reported to the nearest \1/10\ of an
                                           acre or nearest \1/4\ acre. Authorized NPDES programs
                                           will have the discretion to choose whether permittees
                                           should report to the nearest \1/10\ of an acre or
                                           nearest \1/4\ acre for values under 5 acres
Total Impervious Surface Area             This is the estimate of the total impervious area at the  122.26(c)(1)(i)(B)                       1.
 (Industrial)                              facility at the time of permit application (in acres).
                                           This data element is only required for individual
                                           industrial stormwater permit applications. Values under
                                           5 acres will be reported to the nearest \1/10\ of an
                                           acre or nearest \1/4\ acre. Authorized NPDES programs
                                           will have the discretion to choose whether permittees
                                           should report to the nearest \1/10\ of an acre or
                                           nearest \1/4\ acre for values under 5 acres
Proposed Stormwater Best Management       This is the one or more codes that identify the           122.26(c)(1)(i)(B)                       1.
 Practices (Industrial)                    structural and non-structural control measures
                                           (including treatment) to control pollutants in
                                           stormwater discharges from industrial activities. This
                                           data element includes long-term measures (e.g., good
                                           housekeeping of waste-handling and waste-storage areas,
                                           collecting debris and yard material, proper management
                                           of vehicle wash and equipment maintenance areas) and
                                           permanent structures (e.g., covers, pads, diversion
                                           berms or channels, vegetative buffer strips, erosion
                                           prevention and sediment control such as land grading,
                                           riprap slope protection, streambank protection) to
                                           control pollutants in stormwater discharges. This data
                                           element is only required for individual industrial
                                           stormwater permit applications
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                         Municipal Separate Storm Sewer System (MS4) Information on NPDES Permit Application or Notice of Intent
--------------------------------------------------------------------------------------------------------------------------------------------------------
MS4 Permit Class                          The unique code/description that identifies the size of   122.26, 122.28(b)(2)(ii)                 1, 2.
                                           the MS4 permit holder (e.g., Phase I = large or medium
                                           MS4s, Phase II = small MS4s)
Unique Identifier for Each Municipality   The unique identifier for each municipality covered       122.21(f), 122.26(d) 122.28(b)(2)(ii),   1, 2, 6.
 Covered Under MS4 Permit                  under MS4 permit. Use of this identifier allows for       122.34(g)(3), and 122.42(c)
                                           greater geographic resolution for the MS4 components
                                           being tracked. This unique identifier does not change
                                           over time. Use of this unique identifier is similar to
                                           how the `Permitted Feature Identifier (Permit)' data
                                           element is used to distinguish between permitted
                                           features
MS4 Public Education Program              The one or more unique codes/descriptions that            122.21(f), 122.26(d)(2)(iv)(A)(6),       1, 2.
                                           identifies the educational materials the permittee        (B)(5) and (6), and (D)(4);
                                           intends to distribute or equivalent outreach activities   122.28(b)(2)(ii), 122.34(b)(1),
                                           the permittee will implement to inform the target         122.34(d)(1)(i)
                                           audience about the impacts of stormwater discharges and
                                           the steps the public can take to reduce stormwater
                                           pollutants
MS4 Measurable Goals Associated With      The one or more unique codes/descriptions that            122.34(d)(1)(ii), 122.28(b)(2)(ii)       1, 2.
 Public Education Program                  identifies measurable goals associated with the public
                                           education programs including, as appropriate, the
                                           months and years in which the permittee will undertake
                                           required actions, including interim milestones and the
                                           frequency of the action. This data element only applies
                                           to Phase II MS4s
MS4 Public Involvement and Participation  The one or more unique codes/descriptions that            122.21(f), 122.26(d)(2)(iv),             1, 2.
 Program                                   identifies how the permittee intends to involve the       122.28(b)(2)(ii), 122.34(b)(2),
                                           public and at minimum comply with State, Tribal, and      122.34(d)(1)(i)
                                           local public notice requirements to implement its
                                           public involvement and participation program
MS4 Measurable Goals for the Public       The one or more unique codes/descriptions that            122.28(b)(2)(ii) 122.34(d)(1)(ii)        1, 2.
 Involvement and Participation Program     identifies the measurable goals associated with the
                                           public involvement and participation program including,
                                           as appropriate, the months and years in which the
                                           permittee will undertake required actions, including
                                           interim milestones and the frequency of the action.
                                           This data element only applies to Phase II MS4s
MS4 Illicit Discharge Detection and       The one or more unique codes/descriptions that identify   122.21(f), 122.26(d)(1)(iii)(B),         1, 2.
 Elimination                               how the permittee will comply with Illicit Discharge      122.26(d)(2)(i)(B) and (C),
                                           Detection and Elimination requirements, including (at a   122.26(d)(2)(iv)(B), 122.28(b)(2)(ii),
                                           minimum): (1) The status of the permittee's storm sewer   122.34(b)(3)(ii)(A)-(D),
                                           system map showing the location of all outfalls and       122.34(d)(1)(i)
                                           names and locations of all waters of the U.S. that
                                           receive discharges from those outfalls; (2) the status
                                           of the ordinance or other regulatory mechanism to
                                           prohibit non-stormwater discharges into the permittee's
                                           MS4; (3) the procedures and actions the permittee takes
                                           to enforce the prohibition of non-stormwater discharges
                                           to the permittee's MS4; (4) the status of the program
                                           that identifies the procedures and actions the
                                           permittee will take to detect and address non-
                                           stormwater discharges, including illegal dumping, to
                                           the permittee's MS4; and (5) the status of procedures
                                           and actions the permittee will take to inform public
                                           employees, businesses and the general public of hazards
                                           associated with illegal discharges and improper
                                           disposal of waste
MS4 Measurable Goals Associated With      The one or more unique codes/descriptions that            122.34(d)(1)(ii)                         1, 2.
 Illicit Discharge Detection and           identifies the measurable goals associated with the
 Elimination Program                       illicit discharge detection and elimination program,
                                           including, as appropriate, the months and years in
                                           which the permittee will undertake required actions,
                                           including interim milestones and the frequency of the
                                           action. This data element only applies to Phase II MS4s
MS4 Construction Site Stormwater Runoff   The one or more unique codes/descriptions that identify   122.21(f), 122.26(d)(2)(iv)(D),          1, 2.
 Control                                   how the permittee will comply with the Construction       122.28(b)(2)(ii), 122.34(b)(4)(ii),
                                           Site Runoff Control requirements, including (at a         122.34(d)(1)(i)
                                           minimum): (1) status of the ordinance or other
                                           regulatory mechanism to require erosion and sediment
                                           controls, including sanctions to ensure compliance; (2)
                                           status of requirements for construction site operators
                                           to implement appropriate erosion and sediment control
                                           BMPs and control waste at the construction site that
                                           may cause adverse impacts to water quality; (3) status
                                           of procedures for site plan review that incorporate
                                           consideration of potential water quality impacts; (4)
                                           status of procedures for receipt and consideration of
                                           information submitted by the public; and (5) status of
                                           procedures for site inspection and enforcement of
                                           control measures
MS4 Measurable Goals Associated with the  The one or more unique codes/descriptions that identify   122.34(d)(1)(ii)                         1, 2.
 Construction Site Stormwater Runoff       the measurable goals associated with the construction
 Control Program                           program, including, as appropriate, the months and
                                           years in which the permittee will undertake required
                                           actions, including interim milestones and the frequency
                                           of the action. This data element only applies to Phase
                                           II MS4s
MS4 Post-Construction Stormwater          The one or more unique codes/descriptions that identify   122.21(f), 122.26(d)(2)(iv)(A)(2),       1, 2.
 Management In New Development And         how the permittee will comply with the Post-              122.28(b)(2)(ii), 122.34(b)(5),
 Redevelopment                             Construction Stormwater Management in New Development     122.34(d)(1)(i)
                                           and Redevelopment requirements, including (at a
                                           minimum): (1) Status of ordinance or other regulatory
                                           mechanism to address post-construction runoff from new
                                           development and redevelopment projects; (2) how the
                                           permittee plans to address stormwater runoff from new
                                           development and redevelopment projects that disturb a
                                           minimum of greater than or equal to one acre (including
                                           if the permittee requires on-site retention of
                                           stormwater; and (3) status of a plan to ensure adequate
                                           long-term operation and maintenance of BMPs for
                                           controlling runoff from new development and
                                           redevelopment projects
MS4 Measurable Goals Associated with the  The one or more unique codes/descriptions that identify   122.34(d)(1)(ii)                         1, 2.
 Post-Construction: Stormwater             the measurable goals associated with the post-
 Management Program                        construction program, including, as appropriate, the
                                           months and years in which the permittee will undertake
                                           required actions, including interim milestones and the
                                           frequency of the action. This data element only applies
                                           to Phase II MS4s
MS4 Pollution Prevention/Good             The one or more unique codes/descriptions that identify   122.21(f), 122.26(d)(2)(iv)(A)(1), (2)   1, 2.
 Housekeeping for Municipal Operations     how the permittee will comply with the Pollution          and (3), 122.28(b)(2)(ii),
 Program                                   Prevention/Good Housekeeping requirements                 122.34(b)(6)(i), 122.34(d)(1)(i)
MS4 Additional Measures                   The one or more unique codes/descriptions that identify   122.28(b)(2)(ii), 122.34(b), 122.34(d)   1, 2.
                                           any other additional measures that are required by the    122.44(d)(1)(vii)(B)
                                           permit such as controls to be consistent with the
                                           assumptions and requirements of any available wasteload
                                           allocation prepared by a state and approved by EPA.
                                           This data element is optional if there are no MS4
                                           additional measures
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                                            POTW Information on NPDES Permit Application or Notice of Intent
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Name of Collection System                 This is the unique name of each collection system that    122.1(b) and 122.21(j)(1)(iv),           1, 2.
                                           provides flow to the permittee. This includes             122.28(b)(2)(ii)
                                           unincorporated connector districts and satellite
                                           collection systems, which are sanitary sewers owned or
                                           operated by another entity that conveys sewage or
                                           industrial wastewater to this permittee. This data
                                           element applies to POTWs
Owner Type of Collection System           The unique code/description that identifies the           122.1(b) and 122.21(j)(1)(iv),           1, 2.
                                           ownership type for each unique collection system that     122.28(b)(2)(ii)
                                           provides flow to the permittee (e.g., municipality
                                           owned, privately owned). This includes unincorporated
                                           connector districts and satellite collection systems.
                                           This data element applies to POTWs
Collection System Identifier              This is the NPDES permit number (``NPDES ID'') for each   122.1(b) and 122.21(j)(1)(iv),           1, 2.
                                           unique collection system that provides flow to the        122.28(b)(2)(ii)
                                           permittee. If there is no NPDES permit number for the
                                           collection system this data element will be a unique
                                           identifier for each collection system that provides
                                           flow to the permittee. This includes unincorporated
                                           connector districts and satellite collection systems.
                                           This data element applies to POTWs
Population of Collection System           This is the estimated population for each unique          122.1(b) and 122.21(j)(1)(iv),           1, 2.
                                           collection system that provides flow to the permittee.    122.28(b)(2)(ii)
                                           This includes unincorporated connector districts and
                                           satellite collection systems. This data element applies
                                           to POTWs
Percentage of Collection System That Is   For each unique collection system that provides flow to   122.1(b) and 122.21(j)(1)(iv) and        1, 2.
 a Combined Sewer System                   the permittee, this is the estimated percentage of the    (vii), 122.28(b)(2)(ii)
                                           collection system that is a combined sewer system. This
                                           includes unincorporated connector districts and
                                           satellite collection systems. This estimated percentage
                                           is calculated separately for each unique collection
                                           system that provides flow to the permittee and is based
                                           on the service population of each unique collection
                                           system. This data element applies to POTWs
POTW Wastewater Treatment Technology      This data element describes the level of wastewater       122.21(j)(3)(iii), 122.28(b)(2)(ii) and  1, 2.
 Level Description                         treatment technology [e.g., raw discharge (no             CWA section 516
                                           treatment), primary treatment, secondary wastewater
                                           treatment, advanced treatment] used at the facility.
                                           This data element only applies to POTWs
POTW Wastewater Disinfection Technology   The one or more unique codes/descriptions that describe   122.21(j)(3)(iii), 122.28(b)(2)(ii)      1, 2.
                                           the types of disinfection technology that are used at
                                           the facility (e.g., chlorination, ozonation,
                                           ultraviolet disinfection). This data element will also
                                           use a code/description to identify if this facility is
                                           using dechlorination, which may be required if the
                                           facility uses chlorination for disinfection. This data
                                           element only applies to POTWs
POTW Wastewater Treatment Technology      The one or more unique codes/descriptions that describe   122.21(j)(2)(ii)(A), 122.28(b)(2)(ii)    1, 2.
 Unit Operations                           the wastewater treatment technology unit operations       and CWA section 516
                                           (e.g., grit removal, flow equalization, complete mix
                                           activated sludge secondary treatment, trickling filter,
                                           facultative lagoon, biological nitrification) used at
                                           the facility. This data element is required for POTWs
                                           that have a design flow capacity equal to or above 10
                                           million gallons per day (MGD) and is optional for POTWs
                                           with a design flow capacity below 10 MGD
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                                                           Combined Sewer Overflow Information
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       [Note: All Phase II and post-Phase II combined sewer system NPDES permittees are required to complete and implement a long-term CSO control plan
   (LTCP) as described in EPA's Combined Sewer Overflow (CSO) Control Policy (19 April 1994; 59 Federal Register 18688-18698). These data will be
   updated by the authorized NPDES program on a timely basis as changes occur with the combined sewer system and the LTCP as well as with the POTW's
   implementation and compliance with the LTCP.]
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Long-Term CSO Control Plan Permit         This data element uses a unique code/description that     122.41(h), 122.43, 123.41(a) and CWA     1.
 Requirements and Compliance               identifies whether the permit requires the permit         section 402(q)(1), Combined Sewer
                                           holder to complete and implement a LTCP and whether the   Overflow (CSO) Control Policy (59 FR
                                           permit holder is in compliance with these permit          18688-18698, 19 April 1994)
                                           requirements
Nine Minimum CSO Controls Developed       This data element uses a unique code/description to       122.41(h), 122.43, 123.41(a) and CWA     1.
                                           identify by number each of the nine minimum control       section 402(q)(1), Combined Sewer
                                           measures outlines in the CSO Control Policy that the      Overflow (CSO) Control Policy (59 FR
                                           permit holder has implemented in compliance with the      18688-18698, 19 April 1994)
                                           applicable permit and/or enforcement mechanism. These
                                           unique codes are: (1) Proper operation and regular
                                           maintenance programs for the sewer system and the CSOs;
                                           (2) Maximum use of the collection system for storage;
                                           (3) Review and modification of pretreatment
                                           requirements to assure CSO impacts are minimized; (4)
                                           Maximization of flow to the publicly owned treatment
                                           works for treatment; (5) Prohibition of CSOs during dry
                                           weather; (6) Control of solid and floatable materials
                                           in CSOs; (7) Pollution prevention; (8) Public
                                           notification to ensure that the public receives
                                           adequate notification of CSO occurrences and CSO
                                           impacts; and (9) Monitoring to effectively characterize
                                           CSO impacts and the efficacy of CSO controls. For
                                           example, if the permit holder has only developed the
                                           ``Maximum use of the collection system for storage''
                                           minimum control measure then the permitting authority
                                           will record ``2'' for this data element. Likewise, if
                                           the permit holder has developed all nine minimum
                                           control measures then permitting authority will record
                                           1, 2, 3, 4, 5, 6, 7, 8, and 9 for this data element
Nine Minimum CSO Controls Implemented     This data element uses a unique code/description to       122.41(h), 122.43, 123.41(a) and CWA     1.
                                           identify by number each of nine minimum control           section 402(q)(1), Combined Sewer
                                           measures outlined in the CSO Control Policy that the      Overflow (CSO) Control Policy (59 FR
                                           permit holder has implemented in compliance with the      18688-18698, 19 April 1994)
                                           applicable permit and/or enforcement mechanism. These
                                           unique codes are: (1) Proper operation and regular
                                           maintenance programs for the sewer system and the CSOs;
                                           (2) Maximum use of the collection system for storage;
                                           (3) Review and modification of pretreatment
                                           requirements to assure CSO impacts are minimized; (4)
                                           Maximization of flow to the publicly owned treatment
                                           works for treatment; (5) Prohibition of CSOs during dry
                                           weather; (6) Control of solid and floatable materials
                                           in CSOs; (7) Pollution prevention; (8) Public
                                           notification to ensure that the public receives
                                           adequate notification of CSO occurrences and CSO
                                           impacts; and (9) Monitoring to effectively characterize
                                           CSO impacts and the efficacy of CSO controls. For
                                           example, if the permit holder has only developed the
                                           ``Maximum use of the collection system for storage''
                                           minimum control measure then the permitting authority
                                           will record ``2'' for this data element. Likewise, if
                                           the permit holder has developed all nine minimum
                                           control measures then permitting authority will record
                                           1, 2, 3, 4, 5, 6, 7, 8, and 9 for this data element
LTCP Submission and Approval Type         This data element uses a unique code/description to       122.41(h), 122.43, 123.41(a) and CWA     1.
                                           identify whether the most recent version of the LTCP      section 402(q)(1), Combined Sewer
                                           was received and approved by the permitting authority     Overflow (CSO) Control Policy (59 FR
                                           (e.g., most recent version of the LTCP was submitted by   18688-18698, 19 April 1994)
                                           permit holder and was approved by the permitting
                                           authority, most recent version of the LTCP was
                                           submitted by permit holder but has not yet been
                                           approved by permitting authority, permit holder is
                                           required to submit a revised LTCP but the permitting
                                           authority has not yet received the revised LTCP from
                                           the permit holder, permit holder has not yet submitted
                                           a LTCP)
LTCP Approval Date                        This data element identifies the date when the            122.41(h), 122.43, 123.41(a) and CWA     1.
                                           permitting authority approved the most current version    section 402(q)(1), Combined Sewer
                                           of the LTCP. This data element will be updated for each   Overflow (CSO) Control Policy (59 FR
                                           revision to the LTCP. The date must be provided in YYYY-  18688-18698, 19 April 1994)
                                           MM-DD format where YYYY is the year, MM is the month,
                                           and DD is the day
Enforceable Mechanism and Schedule to     This data element uses a unique code/description to       122.41(h), 122.43, 123.41(a) and CWA     1.
 Complete LTCP and CSO Controls            identify whether the permit holder is on an enforceable   section 402(q)(1), Combined Sewer
                                           schedule to complete all required LTCP and CSO controls   Overflow (CSO) Control Policy (59 FR
                                           and the type of enforcement mechanism                     18688-18698, 19 April 1994)
Actual Date Completed LTCP and CSO        This data element identifies the date by which the        122.41(h), 122.43, 123.41(a) and CWA     1.
 Controls                                  permit holder completed construction and implementation   section 402(q)(1), Combined Sewer
                                           of all currently required LTCP and CSO controls. This     Overflow (CSO) Control Policy (59 FR
                                           data element will be updated for each revision to the     18688-18698, 19 April 1994)
                                           LTCP and CSO controls. The date must be provided in
                                           YYYY-MM-DD format where YYYY is the year, MM is the
                                           month, and DD is the day
Approved Post-Construction Compliance     This data element uses a unique code/description to       122.41(h), 122.43, 123.41(a) and CWA     1.
 Monitoring Program                        indicate whether the permit holder is currently           section 402(q)(1), Combined Sewer
                                           implementing an approved post-construction compliance     Overflow (CSO) Control Policy (59 FR
                                           monitoring program                                        18688-18698, 19 April 1994)
Other CSO Control Measures with           This data element uses a unique code/description to       122.41(h), 122.43, 123.41(a) and CWA     1.
 Compliance Schedule                       identify whether the permit holder has other CSO          section 402(q)(1), Combined Sewer
                                           control measures specified in a compliance schedule,      Overflow (CSO) Control Policy (59 FR
                                           beyond those identified in the nine minimum controls,     18688-18698, 19 April 1994)
                                           long-term CSO control plan (LTCP), or a plan for sewer
                                           system separation
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 Pretreatment Information on NPDES Permit Application or Notice of Intent (this includes permit application data required for all new and existing POTWs
                                                                  [40 CFR 122.21(j)(6)]
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       [Note: These data will be added or updated through the Annual Pretreatment Program Report, see 40 CFR 403.12(i), as needed. It is also important
   to note that the `Associated NPDES ID Number' identifies the receiving POTW's NPDES permit number for each industrial user.]
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Pretreatment Program Required Indicator   The unique code/description that describes whether the    122.28(b)(2)(ii), 122.44(j)              1.
                                           permitted municipality is required to develop or
                                           implement a pretreatment program (in accordance with 40
                                           CFR 403)
Pretreatment Program Approval or          The date the pretreatment program was approved or         122.28(b)(2)(ii), 403.8(a) and (b),      1.
 Modification Date                         substantially modified. This data element can be system   403.11
                                           generated by carrying forward the most recent date
                                           (approval or modification). The date must be provided
                                           in YYYY-MM-DD format where YYYY is the year, MM is the
                                           month, and DD is the day
Pretreatment Program Modification Type    The unique code describing the type of substantial        122.28(b)(2)(ii), 403.8(a) and (b),      1.
                                           modification to a POTW Pretreatment Program, which        403.11, 403.18
                                           includes the initial start of a pretreatment program
Industrial User Type                      The unique code/description that identifies the type of   122.21(j)(6), 122.28(b)(2)(ii),          1, 2, 7.
                                           each industrial user discharging to a POTW [e.g.,         122.44(j), 403.12(i)
                                           Significant Industrial User (SIU), Standard Categorical
                                           Industrial Users (CIU), Non-Significant Categorical
                                           Industrial User (NSCIU), and Middle Tier Categorical
                                           Industrial User (MTCIU)]. This data element is at the
                                           permit or control mechanism level and is required for
                                           each SIU, CIU, NSCIU, and MTCIU. This data element also
                                           applies to SIUs and CIUs that discharge non-domestic
                                           wastewater by truck, rail, and dedicated pipe or other
                                           means of transportation to one or more POTWs
Significant Industrial User Subject to    The unique code (e.g., ``Yes'', ``No'') that identifies   122.21(j)(6), 122.28(b)(2)(ii),          1, 2, 7.
 Local Limits                              for each Significant Industrial User (SIU) or             122.44(j), 403.12(i)
                                           Categorical Industrial User (CIU) discharging to a POTW
                                           (including non-domestic wastewater delivered by truck,
                                           rail, and dedicated pipe or other means of
                                           transportation) whether the SIU is subject to local
                                           limits
Significant Industrial User Subject to    The unique code (e.g., ``Yes'', ``No'') that identifies   122.21(j)(6), 122.28(b)(2)(ii),          1, 2, 7.
 Local Limits More Stringent Than          for each Categorical Industrial User (CIU) discharging    122.44(j), 403.12(i)
 Categorical Standards                     to a POTW (including non-domestic wastewater delivered
                                           by truck, rail, and dedicated pipe or other means of
                                           transportation) whether the CIU is subject to one or
                                           more local limits that are more stringent than the
                                           applicable categorical standards
Applicable Categorical Standards          This data element will identify for each Categorical      122.21(j)(6), 122.28(b)(2)(ii),          1, 2, 7.
                                           Industrial User (CIU) discharging to a POTW (including    122.44(j), 403.12(i)
                                           non-domestic wastewater delivered by truck, rail, and
                                           dedicated pipe or other means of transportation) the
                                           applicable categorical standard(s) by its 40 CFR part
                                           number (e.g., Metal Finishing--part 433, Electrical and
                                           Electronic Components--Part 469). This data element
                                           will track the one or more applicable categorical
                                           standards even when the CIU is subject to one or more
                                           local limits that are more stringent than the
                                           applicable categorical standards
Significant Industrial User Wastewater    This data element will identify for each Significant      122.21(j)(6), 122.28(b)(2)(ii),          1, 2.
 Flow Rate                                 Industrial User (SIU) or Categorical Industrial User      122.44(j)
                                           (CIU) that is discharging to a POTW (including non-
                                           domestic wastewater delivered by truck, rail, and
                                           dedicated pipe or other means of transportation) the
                                           estimated maximum monthly average wastewater flow rate
                                           (in gallons per day)
Industrial User Causing Problems at POTW  The unique code/description that identifies for each      122.21(j)(6), 122.28(b)(2)(ii),          1, 2.
                                           Significant Industrial User (SIU) or Categorical          122.44(j)(2)(ii), 403.5(c)
                                           Industrial User (CIU) whether it caused or contributed
                                           to any problems (including upset, bypass, interference,
                                           pass-through) at a POTW within the past four and one-
                                           half calendar years. EPA regulations require the
                                           Control Authority to develop and enforce local limits
                                           when the discharge from an IU causes or contributes to
                                           any problems (including upset, interference, and
                                           bypass) at the receiving POTW's effluent discharge or
                                           biosolids/sewage sludge management. This data element
                                           also applies to SIUs and CIUs that discharge non-
                                           domestic wastewater by truck, rail, and dedicated pipe
                                           or other means of transportation to one or more POTWs
Receiving RCRA Waste                      The unique code/description that identifies whether a     122.21(j)(7), 122.28(b)(2)(ii),          1, 2.
                                           POTW has received RCRA hazardous waste by truck, rail,    122.44(j)
                                           or dedicated pipe within the last three calendar years
Receiving Remediation Waste               The unique code/description that identifies whether the   122.21(j)(7), 122.44(j)                  1, 2.
                                           POTW has received RCRA or CERLCA waste from off-site
                                           remedial activities within the last three calendar
                                           years
Control Authority Identifier              This data element identifies the one or more Control      122.28(b)(2)(ii), 122.44(j)              1, 2.
                                           Authorities for each Significant Industrial User (SIU)
                                           or Categorical Industrial User (CIU). When the Control
                                           Authority is a POTW this data element will use the
                                           POTW's NPDES ID. There will also be a unique identifier
                                           for each state and EPA Region for SIUs and CIUs when
                                           they are the Control Authority
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                                    Cooling Water Intake Information on NPDES Permit Application or Notice of Intent
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Cooling Water Intake Applicable Subpart   The unique code/description that identifies the           122.21(r), 122.28(b)(2)(ii), subparts    1, 2.
                                           regulatory subpart the facility is subject to [e.g., 1    I, J, and N of 125, 401.14, and CWA
                                           = New Facility under 40 CFR part 125, subpart I, 2 =      section 316(b)
                                           New Offshore Oil and Gas Facility under 40 CFR part
                                           125, subpart N, 3 = Existing Facility under 40 CFR part
                                           125, subpart J, 4 = BPJ Facility under 40 CFR
                                           125.80(c), 40 CFR 125.90(b), 40 CFR 125.130(c), or 40
                                           CFR 401.14]
Design Intake Flow for Cooling Water      Design Intake Flow (DIF) means the value, in units of     122.21(r), 122.28(b)(2)(ii), 125.80,     1, 2.
 Intake Structure(s)                       million gallons per day (MGD), assigned to each cooling   125.86, 125.90, 125.92, 125.95,
                                           water intake structure design that corresponds to the     125.131, 125.136, 401.14, and CWA
                                           maximum instantaneous rate of flow of water the cooling   section 316(b)
                                           water intake system is capable of withdrawing from a
                                           source waterbody. The facility's DIF may be adjusted to
                                           reflect permanent changes to the maximum flow
                                           capability of the cooling water intake system to
                                           withdraw cooling water, including pumps permanently
                                           removed from service, flow limit devices, and physical
                                           limitations of the piping. DIF does not include values
                                           associated with emergency and fire suppression capacity
                                           or redundant pumps (i.e., back-up pumps). For new
                                           facilities this is the design maximum flow capacity of
                                           the cooling water intake structure. See 40 CFR 125.83
                                           and 125.92. This data element will be reported for each
                                           cooling water intake structure, which will have a
                                           ``Permitted Feature ID.'' Specific monitoring protocols
                                           and frequency of monitoring will be determined by the
                                           Director
Actual Intake Flow for Cooling Water      This actual flow value, in units of MGD, is intended to   122.21(r), 122.28(b)(2)(ii),             1, 2.
 Intake Structure(s)                       represent on-the-ground intake flow for each cooling      125.86,125.92(a), 125.95, 125.136,
                                           water intake structure at the facility, as opposed to     401.14, and CWA section 316(b)
                                           the DIF, which is based on maximum design flow intake.
                                           For existing facility, Actual Intake Flow (AIF) means
                                           the average flow rate of water withdrawn on an annual
                                           basis by each cooling water intake structure over the
                                           past three years. After October 14, 2019, AIF means the
                                           average flow rate of water withdrawn on an annual basis
                                           by each cooling water intake structure over the
                                           previous five years. Actual intake flow is measured at
                                           a location within the cooling water intake structure
                                           that the Director deems appropriate. The calculation of
                                           actual intake flow includes days of zero flow. AIF does
                                           not include flows associated with emergency and fire
                                           suppression capacity. See 40 CFR 125.92. This data
                                           element will be reported for each cooling water intake
                                           structure, which will have a ``Permitted Feature ID.''
                                           Specific monitoring protocols and frequency of
                                           monitoring will be determined by the Director
Location Type for Cooling Water Intake    The unique code/description that identifies the location  122.21(r), 122.28(b)(2)(ii), 125.86,     1, 2.
 Structure                                 and description for each cooling water intake structure   125.95, 125.136, 401.14 and CWA
                                           [e.g., 1 = shoreline intake description (flushed,         section 316(b)
                                           recessed), 2 = intake canal, 3 = embayment, bank, or
                                           cove, 4 = submerged offshore intake, 5 = near-shore
                                           submerged intake, 6 = shoreline submerged intake, 7 =
                                           Offshore Velocity Cap (800 foot minimum distance from
                                           shoreline), 8 = other]. Each cooling water intake
                                           structure will have its own ``Permitted Feature ID''
Actual Through-Screen Velocity            This is the actual through-screen velocity (in feet/      122.21(r), 122.28(b)(2), 125.86,         1, 2.
                                           second) of the water intake through the screen for each   125.94, 125.95, 125.136, 401.14 and
                                           cooling water intake structure at an existing facility.   CWA section 316(b)
                                           This is the measured average intake velocity as water
                                           passes through the structural components of a screen
                                           measured perpendicular to the screen mesh during normal
                                           operations. See 40 CFR 125.94. This data element will
                                           be reported for each cooling water intake structure,
                                           which will have a ``Permitted Feature ID.'' Specific
                                           monitoring protocols and frequency of monitoring will
                                           be determined by the Director
Source Water for Cooling Purposes         The unique code/description that describes the one or     122.21(r), 122.28(b)(2)(ii), 125.86,     1, 2.
                                           more source water for cooling purpose for each cooling    125.95, 125.136, 401.14 and CWA
                                           water intake structure [e.g., 1 = Ocean, 2 = Estuary, 3   section 316(b)
                                           = Great Lake, 4 = Fresh River, 5 = Lake/Reservoir, 6 =
                                           contract or arrangement with an independent supplier
                                           (or multiple suppliers)]. Each cooling water intake
                                           structure will have its own ``Permitted Feature ID''
Cooling Water Intake Structure Chosen     The unique code/description to indicate the one or more   122.21(r)(6), 122.28(b)(2)(ii), 125.84,  1, 2.
 Compliance Method                         compliance method selected for each cooling water         125.85, 125.94, 125.134, 125.135,
                                           intake structure based on EPA's CWA section 316(b)        401.14 and CWA section 316(b)
                                           regulations or based on BPJ. For new facilities for
                                           example, Track I, Track II, alternative requirements,
                                           etc. For existing facilities, which of the 40 CFR
                                           125.94(c) compliance options were chosen and reported
                                           as part of 40 CFR 122.21(r)(6), whether the facility
                                           has chosen to comply on an intake basis or facility
                                           wide, or whether alternative requirements were
                                           requested. Facilities have the option to comply on a
                                           facility wide or on an intake basis. Each cooling water
                                           intake structure will have its own ``Permitted Feature
                                           ID''
Source Water Baseline Biological          For new and existing facilities, a unique code/           122.21(r)(4), 122.28(b)(2), 125.86,      1, 2.
 Characterization Data: Threatened or      description that identifies whether there are Federally-  125.95, 125.136, 401.14 and CWA
 Endangered Status                         listed threatened or endangered species (or relevant      section 316(b)
                                           taxa) that might be susceptible to impingement and
                                           entrainment at the facility's cooling water intake
                                           structures. This unique code/description will also
                                           identify whether designated critical habitat is in the
                                           vicinity of facility's cooling water intake structure
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                             CWA section 316(a) Thermal Variance Information on NPDES Permit Application or Notice of Intent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Thermal Variance Request Type             The unique code/description that describes the thermal    125, subpart H and CWA section 316(a)    1.
                                           variance request submitted by the discharger (e.g., 1 =
                                           new request, 2 = renewal request)
Public Notice of Section 316(a) Requests  This is the unique code that describes whether the NPDES  124.57, 125, subpart H and CWA section   1.
                                           permitting authority included the information required    316(a)
                                           under 40 CFR 124.57(a) in the public notice regarding
                                           the CWA section 316(a) request
Thermal Variance Granted Date             This is the most recent date when the NPDES permitting    1.
                                           authority granted or renewed a CWA section 316(a)
                                           variance for the controlling NPDES permit. The date
                                           must be provided in YYYY-MM-DD format where YYYY is the
                                           year, MM is the month, and DD is the
                                           day122.28(b)(2)(ii), subpart H of 125 and CWA section
                                           316(a)
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                                                  Compliance Monitoring Activity Information (General)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Monitoring Identifier          The unique identifier for the compliance monitoring       123.26, 123.41(a) and CWA section 308    1.
                                           activity performed by the authorized NPDES program and
                                           EPA (e.g., inspections). This data element can be
                                           system generated
Permitted Feature Identifier (Compliance  The unique identifier for the permitted feature           122.34(g)(3), 122.41(l)(4)(i),           1, 3, 4, 6,
 Monitoring Activity)                      number(s) entered by the user for the inspected or        122.41(l)(6) and (7), 122.41(m)(3),      8, and 9.
                                           monitored permitted feature(s). This data element will    123.26, 123.41(a), 122.42(c),
                                           use the same number used by `Permitted Feature            403.12(e), 403.12(h) and CWA section
                                           Identifier (Permit)' data element for each compliance     308
                                           monitoring activity permitted feature. This will
                                           provide a unique link between each compliance
                                           monitoring activity permitted feature and the
                                           corresponding NPDES permitted feature. This data
                                           element can be left blank if the compliance monitoring
                                           activity does not involve a permitted feature. For
                                           Sewer Overflow/Bypass Event Reports this data element
                                           will identify the permitted feature(s), if any, for
                                           each Sewer Overflow/Bypass Identifier. The POTW can
                                           leave this data element blank on the Sewer Overflow/
                                           Bypass Event Report if the sewer overflows are caused
                                           by an extreme weather event (e.g., hurricane) that
                                           floods the entire sewer system and are too numerous to
                                           count. This data element applies to compliance
                                           monitoring activities performed by the authorized NPDES
                                           program and EPA (e.g., inspections) as well as
                                           compliance monitoring reports submitted by the NPDES
                                           regulated entity (e.g., DMRs, program reports)
Electronic Submission Type (Compliance    This is the unique code/description for each report       123.26, 123.41(a) and CWA section 308    1.
 Monitoring Activity)                      submitted by the NPDES regulated entity. Report
                                           submissions covered by the data element are listed in
                                           Table 1 in this appendix (i.e., NPDES Data Groups 3
                                           through 10). This data element describes how each
                                           submission was electronically collected or processed by
                                           the initial recipient [see  127.2(b)]. For example,
                                           these unique codes/descriptions include: (1) NPDES
                                           regulated entity submits NPDES program data using an
                                           EPA electronic reporting system; (2) NPDES regulated
                                           entity submits NPDES program data using an authorized
                                           NPDES program electronic reporting system; (3) NPDES
                                           regulated entity has temporary waiver from electronic
                                           reporting and submits NPDES program data on paper to
                                           the authorized NPDES program who then electronically
                                           uses manual data entry to electronically process these
                                           data; (4) NPDES regulated entity has a permanent waiver
                                           from electronic reporting and submits NPDES program
                                           data on paper to the authorized NPDES program who then
                                           electronically uses manual data entry to electronically
                                           process these data; (5) NPDES regulated entity has an
                                           episodic waiver from electronic reporting and submits
                                           NPDES program data on paper to the authorized NPDES
                                           program who then electronically uses manual data entry
                                           to electronically process these data; (6) NPDES
                                           regulated entity submits NPDES program data on paper in
                                           a form that allows the authorized NPDES program to use
                                           of automatic identification and data capture technology
                                           to electronically process these data; (7) NPDES
                                           regulated entity submits NPDES program data using
                                           another electronic reporting system (e.g., third-
                                           party). This data element can sometimes be system
                                           generated (e.g., incorporated into an electronic
                                           reporting tool). This data element does not identify
                                           the electronic submission type of general permit
                                           reports (NPDES Data Group = 2 in Table 1), which is
                                           tracked by the ``Electronic Submission Type (General
                                           Permit Reports)'' data element. This data element
                                           applies to information submitted by NPDES regulated
                                           entities and does not apply to compliance monitoring
                                           information generated by authorized NPDES programs and
                                           EPA (e.g., inspection data)
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                       Compliance Monitoring Activity Information (General Data Generated from Authorized NPDES Programs and EPA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Monitoring Activity Actual     The actual date on which the compliance monitoring        123.26, 123.41(a) and CWA section 308    1.
 End Date                                  activity ended. For example, the date of an authorized
                                           NPDES program inspection of a facility can be used for
                                           this data element. The date must be provided in YYYY-MM-
                                           DD format where YYYY is the year, MM is the month, and
                                           DD is the day
Compliance Monitoring Activity            The unique code/description that identifies each          123.26, 123.41(a) and CWA section 308    1.
                                           compliance monitoring activity taken by the authorized
                                           NPDES program (e.g., inspection, investigation,
                                           information request, offsite records review)
Compliance Monitoring Type                The unique code/description that identifies each          123.26, 123.41(a) and CWA section 308    1.
                                           compliance monitoring activity type taken by a
                                           regulatory Agency (e.g., audit, biomonitoring, case
                                           development, diagnostic, evaluation, reconnaissance
                                           with sampling, reconnaissance without sampling,
                                           sampling)
Biomonitoring Test Type                   The unique code/description that identifies the type of   123.26, 123.41(a) and CWA section 308    1.
                                           biomonitoring inspection method (e.g., acute, chronic,
                                           or flow through) and sample type (e.g., grab,
                                           composite). This data element supplements the
                                           Compliance Monitoring Type data element. This data
                                           element only applies to compliance monitoring
                                           activities that involve biomonitoring
Compliance Monitoring Action Reason       The unique code/description that identifies the reason    123.26, 123.41(a) and CWA section 308    1.
                                           for the initiation of the compliance monitoring
                                           activity (e.g., Agency Priority, Citizen Complaint/Tip,
                                           Core Program)
Was this a State, Federal or Joint        This data element identifies if the inspection is a       123.26, 123.41(a) and CWA section 308    1.
 (State/Federal) Inspection?               joint inspection by [F]ederal, [S]tate, [T]ribal, or
                                           territorial personnel. Only one value for this data
                                           element may be used for each compliance monitoring
                                           activity [e.g., State, Federal, Joint (State/Federal)]
Programs Evaluated                        The unique code/description for the one or more programs  123.26, 123.41(a) and CWA section 308    1.
                                           evaluated or related to the compliance monitoring
                                           activity (e.g., NPDES Base Program, Biosolids/Sewage
                                           Sludge, Pretreatment, and MS4)
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                       Compliance Monitoring Activity Information (Program Data Generated from Authorized NPDES Programs and EPA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Deficiencies Identified Through the       This is the unique code/description that that identifies  123.26, 123.41(a), 123.45 and CWA        1.
 Biosolids/Sewage Sludge Compliance        each deficiency in the facility's biosolids and sewage    section 308
 Monitoring                                sludge program (40 CFR part 503) for each compliance
                                           monitoring activity (e.g., inspections, audits) by the
                                           regulatory authority. This data element includes unique
                                           codes to identify when the facility failed to comply
                                           with any applicable permit requirements or enforcement
                                           actions. The values for this data element will
                                           distinguish between noncompliance and significant
                                           noncompliance (SNC)
Deficiencies Identified Through the MS4   This is the unique code/description that that identifies  123.26, 123.41(a), 123.45 and CWA        1.
 Compliance Monitoring                     each deficiency in the MS4's program to control           section 308
                                           stormwater pollution for each compliance monitoring
                                           activity (e.g., inspections, audits) by the regulatory
                                           authority. This data element includes unique codes to
                                           identify when the MS4 failed to comply with any
                                           applicable permit requirements or enforcement actions.
                                           The values for this data element will distinguish
                                           between noncompliance and significant noncompliance
                                           (SNC)
Deficiencies Identified Through the       This is the unique code/description that that identifies  123.26, 123.41(a), 123.45, 403.10, and   1.
 Pretreatment Compliance Monitoring        each deficiency in the POTW's authorized pretreatment     CWA section 308
                                           program for each pretreatment compliance monitoring
                                           activity (e.g., inspections, audits) by the regulatory
                                           authority. The values for this data element will
                                           distinguish between noncompliance and significant
                                           noncompliance (SNC). These unique codes include: (1)
                                           Failure to enforce against pass through and/or
                                           interference; (2) failure to submit required reports
                                           within 30 days; (3) failure to meet compliance schedule
                                           milestones within 90 days; (4) failure to issue/reissue
                                           control mechanisms to 90% of SIUs within 6 months; (5)
                                           failure to inspect or sample 80% of SIUs within the
                                           past 12 months; and (6) failure to enforce standards
                                           and reporting requirements
Deficiencies Identified Through the       This is the unique code/description that that identifies  122.41(h), 122.41(l)(6) and (7),         1.
 Sewer Overflow/Bypass Compliance          each deficiency in the POTW's control of combined sewer   122.43, 123.26, 123.41(a), and CWA
 Monitoring                                overflows, sanitary sewer overflows, or bypass events     sections 308 and 402(q)(1)
                                           for each compliance monitoring activity (e.g.,
                                           inspections, audits) by the regulatory authority. This
                                           data element includes unique codes to identify when a
                                           POTW has failed to provide 24-hour notification to the
                                           NPDES permitting authority or failed to submit the
                                           Sewer Overflow/Bypass Event Report within the required
                                           5-day period. This data element also includes unique
                                           codes to identify when the POTW failed to comply with
                                           any applicable long-term CSO control plan, permit
                                           requirements, or enforcement actions. The values for
                                           data element will distinguish between noncompliance and
                                           significant noncompliance (SNC)
--------------------------------------------------------------------------------------------------------------------------------------------------------
                   Compliance Monitoring Activity Information (AFO/CAFO Program Data Generated from Authorized NPDES Programs and EPA)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Animal Types (Inspection)                 The unique code/description that identifies the animal    122.23, 123.26, 123.41(a), and CWA       1.
                                           type(s) at the facility at the time of inspection         section 308
                                           (e.g., beef cattle, broilers, layers, swine weighing 55
                                           pounds or more, swine weighing less than 55 pounds,
                                           mature dairy cows, dairy heifers, veal calves, sheep
                                           and lambs, horses, ducks, turkeys, other)
Animal Numbers (Inspection)               The number of each type of animal in open confinement or  122.23, 123.26, 123.41(a) and CWA        1.
                                           housed under roof (either partially or totally) which     section 308
                                           are held at the facility at the time of inspection
Animal Numbers in Open Confinement        The number of each type of animal in open confinement     122.23, 123.26, 123.41(a) and CWA        1.
 (Inspection)                              which are held at the facility at the time of             section 308
                                           inspection
MLPW Containment and Storage Type         The one or more types of containment and storage (e.g.,   122.23, 123.26, 123.41(a) and CWA        1.
 (Inspection)                              anaerobic lagoon, roofed storage shed, storage ponds,     section 308
                                           underfloor pits, above ground storage tanks, below
                                           ground storage tanks, concrete pad, impervious soil
                                           pad, other) at the facility at the time of inspection
MLPW Containment and Storage Type Within  The one or more unique codes/descriptions that            122.23, 123.26, 123.41(a) and CWA        1.
 Design Capacity (Inspection)              identifies whether or not the facility is operating       section 308
                                           within the design capacity for each type of containment
                                           and storage used by the facility for MLPW at the time
                                           of inspection
AFO/CAFO Unauthorized Discharges          A unique code (e.g., ``Yes'', ``No'') that indicates      122.23, 123.26, 123.41(a) and CWA        1.
 (Inspection)                              whether there evidence of unauthorized discharge(s) of    section 308
                                           pollutants from the facility's production area and/or
                                           land application area(s) to a water of the U.S.
Permit Requirements Implementation        The unique code/description that identifies whether or    122.23, 123.26, 123.41(a) and CWA        1.
 (Inspection)                              not the facility is properly implementing its NPDES       section 308
                                           permit requirements, including the applicable Nutrient
                                           Management Plan (NMP) or other nutrient management
                                           planning, at the time of inspection
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 Compliance Monitoring Activity Information (Discharge Monitoring Report, and Pretreatment Periodic Compliance Reports for Significant Industrial Users
                             (SIUs) and Categorical Industrial Users (CIUs) when EPA or the State is the Control Authority)
--------------------------------------------------------------------------------------------------------------------------------------------------------
       [Note: Authorized NPDES programs will identify in the applicable NPDES permits will identify whether MS4 regulated entities are required to
   submit DMRs.]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Limit Set Designator (Compliance          The unique identifier tying the compliance monitoring     122.41(l)(4)(i), 123.26, 123.41(a),      3, 6, 8.
 Monitoring Activity)                      activity (e.g., DMR submission) to the corresponding      403.12(e), 403.12(h)
                                           Limit Set record
Parameter Code (Compliance Monitoring     The unique code/description identifying the parameter     122.41(l)(4)(i), 123.26, 123.41(a),      3, 6, 8.
 Activity)                                 reported on the compliance monitoring activity (e.g.,     403.12(e), 403.12(h)
                                           DMR submission)
Monitoring Location Code (Compliance      The unique code/description that identifies the           122.41(l)(4)(i), 123.26, 123.41(a),      3, 6, 8.
 Monitoring Activity)                      monitoring location at which the sampling occurred for    403.12(e), 403.12(h)
                                           a compliance monitoring activity parameter (e.g., DMR
                                           submission)
Limit Season Number (Compliance           The unique identifier tying the compliance monitoring     122.41(l)(4)(i), 123.26, 123.41(a),      3, 6, 8.
 Monitoring Activity)                      activity (e.g., DMR submission) to the Limit Season       403.12(e), 403.12(h)
                                           Number of the corresponding limit. This data element is
                                           necessary as a parameter can have different seasonal
                                           limits within a single limit start and end date
Monitoring Period End Date (Compliance    The monitoring period end date for the values covered by  122.41(l)(4)(i), 123.26, 123.41(a),      3, 6, 8.
 Monitoring Activity)                      the compliance monitoring activity (e.g., DMR             403.12(e), 403.12(h)
                                           submission). The date must be provided in YYYY-MM-DD
                                           format where YYYY is the year, MM is the month, and DD
                                           is the day
No Data Indicator (NODI) (Compliance      The unique code/description that indicates the reason     122.41(l)(4)(i), 123.26, 123.41(a),      3, 6, 8.
 Monitoring Activity)                      that ``No Discharge'' or ``No Data'' was reported on      403.12(e), 403.12(h)
                                           the compliance monitoring activity (e.g., DMR
                                           submission) (e.g., B = Below Detection Limit, C = No
                                           Discharge)
Value (Compliance Monitoring Activity)    The number value reported on the compliance monitoring    122.41(l)(4)(i), 123.26, 123.41(a),      3, 6, 8.
                                           activity (e.g., DMR form)                                 403.12(e), 403.12(h)
Quantity or Concentration Units           The unique code/description that identifies the one or    122.41(l)(4)(i), 123.26, 123.41(a),      3, 6, 8.
 (Compliance Monitoring Activity)          more units of measure that are applicable to quantity     403.12(e), 403.12(h)
                                           or concentration limits and measurements as entered on
                                           the compliance monitoring activity (e.g., DMR
                                           submission). This field is optional if the units are
                                           the same as the limit units
Value Received Date (Compliance           The date the compliance monitoring value was received by  122.41(l)(4)(i), 123.26, 123.41(a),      1.
 Monitoring Activity)                      the regulatory authority (e.g., DMR submission). The      403.12(e), 403.12(h)
                                           date must be provided in YYYY-MM-DD format where YYYY
                                           is the year, MM is the month, and DD is the day
Value Type (Compliance Monitoring         The unique code/description identifying a value type      122.41(l)(4)(i), 123.26, 123.41(a),      3, 6, 8.
 Activity)                                 (e.g., Quantity 1, Quantity 2, Concentration 1,           403.12(e), 403.12(h)
                                           Concentration 2, Concentration 3) on a compliance
                                           monitoring activity (e.g., DMR submission)
Value Qualifier (Compliance Monitoring    The unique code identifying the qualifier for the         122.41(l)(4)(i), 123.26, 123.41(a),      3, 6, 8.
 Activity)                                 reported value (e.g., ``<'', ``='', ``>'') on a           403.12(e), 403.12(h)
                                           compliance monitoring activity (e.g., DMR submission).
                                           This field is optional if the qualifier is ``=''
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                                          Compliance Monitoring Activity Information (Periodic Program Reports)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Program Report Received Date              The date the program report was received. The date must   These are data elements that are common  1.
                                           be provided in YYYY-MM-DD format where YYYY is the        to reports required in parts 122, 123,
                                           year, MM is the month, and DD is the day                  403, and 503
Program Report Event ID                   The unique identifier for each program report             These are data elements that are common  1.
                                           submission. This will provide for unique tracking of      to reports required in parts 122, 123,
                                           program report submissions. This data element can be      403, and 503
                                           system generated
Start Date of Reporting Period (Program   The start date of the reporting period for the program    These are data elements that are common  4, 5, 6, 7,
 Report)                                   report. The date must be provided in YYYY-MM-DD format    to reports required in parts 122, 123,   9, 10.
                                           where YYYY is the year, MM is the month, and DD is the    403, and 503
                                           day. For the Sewer Overflow/Bypass Event Report this is
                                           the start or best estimate of the start date for each
                                           Sewer Overflow/Bypass Identifier
End Date of Reporting Period (Program     The end date of the reporting period for the program      These are data elements that are common  4, 5, 6, 7,
 Report)                                   report. The date must be provided in YYYY-MM-DD format    to reports required in parts 122, 123,   9, 10.
                                           where YYYY is the year, MM is the month, and DD is the    403, and 503
                                           day. For the Sewer Overflow/Bypass Event Report this is
                                           the end or best estimate of the end date for each Sewer
                                           Overflow/Bypass Identifier
NPDES Data Group Number (Program Report)  This data element identifies the NPDES Data Group for     These are data elements that are common  4 through
                                           each program report submission. This corresponds to       to reports required in parts 122, 123,   10.
                                           Table 1 in this appendix (e.g., 7 = Pretreatment          403, and 503
                                           Program Reports [40 CFR 403.12(i)]).This data element
                                           also applies to Significant Industrial User Compliance
                                           Reports in Municipalities Without Approved Pretreatment
                                           Programs [40 CFR 403.12(e) and (h)], which is NPDES
                                           Data Group Number 8 (Table 1 in this appendix). This
                                           can be a system generated data element
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                  Compliance Monitoring Activity Information (Data Elements Specific to Sewage Sludge/Biosolids Annual Program Reports)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Biosolids or Sewage Sludge Treatment      The one or more unique codes/descriptions that identify   503.18, 503.28, 503.48                   4.
 Processes                                 the biosolids or sewage sludge treatment process or
                                           processes at the facility. For example, this data
                                           element uses codes to identify treatment processes in
                                           the following categories: preliminary operations (e.g.,
                                           sludge grinding and degritting), thickening
                                           (concentration), stabilization, anaerobic digestion,
                                           aerobic digestion, composting, conditioning,
                                           disinfection (e.g., beta ray irradiation, gamma ray
                                           irradiation, pasteurization), dewatering (e.g.,
                                           centrifugation, sludge drying beds, sludge lagoons),
                                           heat drying, thermal reduction, and methane or biogas
                                           capture and recovery
Biosolids or Sewage Sludge Analytical     The one or more unique codes/descriptions that identify   503.8(b), 503.18, 503.28, 503.48         4.
 Methods                                   each of the analytic methods used by the facility to
                                           analyze enteric viruses, fecal coliforms, helminth ova,
                                           Salmonella sp., and other regulated parameters. For
                                           example, EPA requires facilities to monitor for the
                                           certain parameters, which are listed in Tables 1, 2, 3,
                                           and 4 at 40 CFR 503. 13 and Tables 1 and 2 at 40 CFR
                                           503.23. This data element stores each analytic methods
                                           used by the facility only once for each annual report
                                           (not for each parameter measurement)
Biosolids or Sewage Sludge Form           The one or more unique codes/descriptions that identify   503.18, 503.28, 503.48                   4.
                                           the nature of each biosolids and sewage sludge material
                                           generated by the facility in terms of whether the
                                           material is a biosolid or sewage sludge and whether the
                                           material is ultimately conveyed off-site in bulk or in
                                           bags. The facility will separately report the form for
                                           each biosolids or sewage sludge management practice or
                                           practices used by the facility and pathogen class
Biosolids or Sewage Sludge Management     The one or more unique codes/descriptions that identify   503.18, 503.28, 503.48                   4.
 Practice                                  the type of biosolids or sewage sludge management
                                           practice or practices (e.g., land application, surface
                                           disposal, incineration) used by the facility. The
                                           facility will separately report the management practice
                                           for each biosolids or sewage sludge form and pathogen
                                           class. This data element will also identify the
                                           management practices used by surface disposal site
                                           owners/operators (see 40 CFR 503.24)
Biosolids or Sewage Sludge Pathogen       The one or more unique codes/descriptions that identify   503.18, 503.28, 503.48                   4.
 Class                                     the pathogen class or classes [e.g., Class A, Class B,
                                           Not Applicable (Incineration)] for biosolids or sewage
                                           sludge generated by the facility. The facility will
                                           separately report the pathogen class for each biosolids
                                           or sewage sludge management practice used by the
                                           facility and by each biosolids or sewage sludge form
Biosolids or Sewage Sludge Amount         This is the amount (in dry metric tons) of biosolids or   503.18, 503.28, 503.48                   4.
 (Program Report)                          sewage sludge applied to the land, prepared for sale or
                                           give-away in a bag or other container for application
                                           to the land, or placed on an active sewage sludge unit.
                                           This identification will be made for each biosolids or
                                           sewage sludge management practice used by the facility
                                           and by each biosolids or sewage sludge form as well as
                                           by each biosolids or sewage sludge pathogen class
Biosolids or Sewage Sludge Pathogen       The one or more unique codes/descriptions that identify   503.18, 503.28, 503.48                   4.
 Reduction Options                         the options used by the facility to control pathogens
                                           (e.g., Class A--Alternative 1, Class A--Alternative 2,
                                           Class A--Alternative 3, Class A--Alternative 4, Class
                                           A--Alternative 5, Class A--Alternative 6, Class B--
                                           Alternative 1, Class B--Alternative 2, Class B--
                                           Alternative 3, or pH Adjustment (Domestic Septage). The
                                           facility will separately report the pathogen reduction
                                           options for each biosolids or sewage sludge management
                                           practice used by the facility and by each biosolids or
                                           sewage sludge form as well as by each biosolids or
                                           sewage sludge pathogen class
Biosolids or Sewage Sludge Vector         The one or more unique codes/descriptions that identify   503.18, 503.28, 503.48                   4.
 Attraction Reduction Options              the options used by the facility for vector attraction
                                           reduction. See a listing of these vector attraction
                                           reduction options at 40 CFR 503.33(b)(1) through (11).
                                           The facility will separately report the vector
                                           attraction reduction options for each biosolids or
                                           sewage sludge management practice used by the facility
                                           and by each biosolids or sewage sludge form as well as
                                           by each biosolids or sewage sludge pathogen class
Biosolids or Sewage Sludge Monitored      This is the biosolids or sewage sludge parameter that is  503.18, 503.28, 503.48                   4.
 Parameter                                 monitored by the facility. If there is more than one
                                           class, then the facility will separately report each
                                           monitored parameter for each biosolids or sewage sludge
                                           management practice used by the facility and by each
                                           biosolids or sewage sludge form. EPA requires
                                           facilities to monitor for the certain parameters, which
                                           are listed in Tables 1, 2, 3, and 4 at 40 CFR 503. 13
                                           and Tables 1 and 2 at 40 CFR 503.23, pathogens (e.g.,
                                           fecal coliform, Salmonella sp., enteric viruses,
                                           helminth ova), and vector attraction reduction
                                           parameters (e.g., specific oxygen uptake rate, and
                                           total, fixed, and volatile solids)
Biosolids or Sewage Sludge Monitored      This is the value of the Biosolids or Sewage Sludge       503.18, 503.28, 503.48                   4.
 Parameter Value                           Monitored Parameter
Biosolids or Sewage Sludge Monitored      This is the measurement unit (e.g., mg/kg) associated     503.18, 503.28, 503.48                   4.
 Parameter Units                           with the Biosolids or Sewage Sludge Monitored Parameter
                                           Value
Biosolids or Sewage Sludge Monitored      This is the end date of the monthly monitoring period     503.18, 503.28, 503.48                   4.
 Parameter End Date                        for the biosolids or sewage sludge sampling (e.g., 1/31/
                                           2015 for biosolids or sewage sludge monitoring data in
                                           January 2015). This data element is used to track the
                                           frequency of biosolids or sewage sludge monitoring in
                                           the reporting period (e.g., annual, quarterly, bi-
                                           monthly, or monthly). For example, see Table 1 of 40
                                           CFR 503.16 (Land Application), Table 1 of 40 CFR 503.26
                                           (Surface Disposal)
Biosolids or Sewage Sludge--Surface       This data element is applicable to facilities that use    503.23, 503.28                           4.
 Disposal Maximum Allowable Pollutant      an active surface disposal sites (e.g., monofills,
 Concentration                             surface impoundments, lagoons, waste piles, dedicated
                                           disposal sites, and dedicated beneficial use sites)
                                           without a liner. This data element identifies the
                                           maximum allowable pollutant concentration for each of
                                           the three pollutants: Arsenic, chromium, and nickel (in
                                           units of mg/kg). This data element will use Tables 1
                                           and 2 of 40 CFR 503.23 or the procedures identified in
                                           40 CFR 503.23(b)
Biosolids or Sewage Sludge--Land          This data element is applicable to facilities that use    503.18, 503.28                           4.
 Application or Surface Disposal           land application and/or an active surface disposal site
 Deficiencies                              (e.g., monofills, surface impoundments, lagoons, waste
                                           piles, dedicated disposal sites, and dedicated
                                           beneficial use sites). This data element uses one or
                                           more unique codes/descriptions to identify all
                                           deficiencies in the biosolids or sewage sludge program
                                           within the reporting period. For example, this data
                                           element uses a unique code/description to identify when
                                           a biosolids or sewage sludge pollutant concentration
                                           exceed a ceiling concentration (e.g., Table 1 of 40 CFR
                                           503.13 for facilities utilizing land application). This
                                           data element also uses a unique code/description to
                                           identify when the facility failed to properly collect
                                           and analyze its biosolids or sewage sludge in
                                           accordance with the approved analytical methods
                                           (including appropriate method holding times). This data
                                           element also uses a unique code/description to identify
                                           deficiencies with pathogen reduction and/or vector
                                           attraction reduction. For facilities that use an active
                                           surface disposal site this data element will use a
                                           unique code/description to identify any deficiencies in
                                           meeting the applicable surface disposal requirements
                                           [see 40 CFR 503.24(a) through (n)]
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                           Compliance Monitoring Activity Information (Data Elements Specific to CAFO Annual Program Reports)
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CAFO Animal Types (Program Report)        The unique code/description that identifies the           122.42(e)(4)(i)                          5.
                                           permittee's applicable animal sector(s) in the previous
                                           12 months. This includes (but not limited to) beef
                                           cattle, broilers, layers, swine weighing 55 pounds or
                                           more, swine weighing less than 55 pounds, mature dairy
                                           cows, dairy heifers, veal calves, sheep and lambs,
                                           horses, ducks, and turkeys
CAFO Animal Maximum Number (Program       The estimated maximum number of each type of animal in    122.42(e)(4)(i)                          5.
 Report)                                   open confinement or housed under roof (either partially
                                           or totally) which are held at the facility for a total
                                           of 45 days or more in the previous 12 months
CAFO Animal Maximum Number in Open        The estimated maximum number of each type of animal in    122.42(e)(4)(i)                          5.
 Confinement (Program Report)              open confinement which are held at the facility for a
                                           total of 45 days or more in the previous 12 months
CAFO MLPW (Program Report)                The unique code/description that identifies the type of   122.42(e)(4)(ii)                         5.
                                           CAFO manure, litter, and process wastewater generated
                                           by the facility i.e., in the previous 12 months
CAFO MLPW Amounts (Program Report)        The estimated total amount of CAFO manure, litter, and    122.42(e)(4)(ii)                         5.
                                           process wastewater generated by the facility in the
                                           previous 12 months
CAFO MLPW Amounts Units (Program Report)  The unit (e.g., tons, gallons) for the estimated total    122.42(e)(4)(ii)                         5.
                                           amount of CAFO manure, litter, and process wastewater
                                           generated by the facility i.e., in the previous 12
                                           months
CAFO MLPW Transferred (Program Report)    The estimated total amount of CAFO manure, litter, and    122.42(e)(4)(iii)                        5.
                                           process wastewater generated by the facility i.e., in
                                           the previous 12 months that is transferred to other
                                           persons. The units for this data element will be the
                                           same as the units for the ``CAFO MLPW Amounts (Program
                                           Report)'' data element
Total Number of Acres for Land            Total number of acres for land application covered by     122.42(e)(4)(iv)                         5.
 Application Covered by the Nutrient       the current nutrient management plan
 Management Plan (Program Report)
Total Number of Acres Used for Land       The total number of acres under control of the CAFO and   122.42(e)(4)(v)                          5.
 Application (Program Report)              used for land application in the previous 12 months
Discharge Type (Program Report)           The unique code/description that identifies for each      122.42(e)(4)(vi), 412                    5.
                                           discharge from the permittee's production area in the
                                           previous 12 month whether a 25-year, 24-hour rainfall
                                           event was the cause for the discharge. These data are
                                           optional if permittee uses a Discharge Monitoring
                                           Report (DMR) to provide the permitting authority with
                                           information on their discharges
Discovery Dates of Discharges from        The date of each discharge from the permittee's           122.42(e)(4)(vi)                         5.
 Production Area (Program Report)          production area in the previous 12 months. The date
                                           must be provided in YYYY-MM-DD format where YYYY is the
                                           year, MM is the month, and DD is the day. These data
                                           are optional if permittee uses a Discharge Monitoring
                                           Report (DMR) to provide the permitting authority with
                                           information on their discharges
Duration of Discharges from Production    The estimated duration time (in hours) of each discharge  122.42(e)(4)(vi)                         5.
 Area (Program Report)                     from the permittee's production area in the previous 12
                                           months. These data are optional if permittee uses a
                                           Discharge Monitoring Report (DMR) to provide the
                                           permitting authority with information on their
                                           discharges
Approximate Volume of Discharge from      The approximate volume (in gallons) of each discharge     122.42(e)(4)(vi)                         5.
 Production Area (Program Report)          from the permittee's production area in the previous 12
                                           months. These data are optional if permittee uses a
                                           Discharge Monitoring Report (DMR) to provide the
                                           permitting authority with information on their
                                           discharges
Whether NMP Approved or Developed by      The unique code/description that identifies whether the   122.42(e)(4)(vii)                        5.
 Certified Planner (Program Report)        current version of the NMP was approved or developed by
                                           a certified nutrient management planner
CAFO MLPW Nitrogen Content (Program       The nitrogen content of CAFO manure, litter, and process  122.42(e)(4)(viii)                       5.
 Report)                                   wastewater used or generated by the facility i.e., in
                                           the previous 12 months
CAFO MLPW Phosphorus Content (Program     The phosphorus content of CAFO manure, litter, and        122.42(e)(4)(viii)                       5.
 Report)                                   process wastewater used or generated by the facility
                                           i.e., in the previous 12 months
CAFO MLPW Nitrogen or Phosphorus Units    The unit(s) (e.g., lbs/tons, lbs/1,000-gallons) for the   122.42(e)(4)(viii)                       5.
 (Program Report)                          nitrogen and phosphorus content of CAFO manure, litter,
                                           and process wastewater used or generated by the
                                           facility i.e., in the previous 12 months
CAFO MLPW Nitrogen or Phosphorus Form     The form (e.g., total nitrogen, ammonium-nitrogen, total  122.42(e)(4)(viii)                       5.
 (Program Report)                          phosphorus) for the nitrogen and phosphorus content of
                                           CAFO manure, litter, and process wastewater used or
                                           generated by the facility i.e., in the previous 12
                                           months
Field Identification Number (Program      A unique field number to which CAFO MLPW was applied in   122.42(e)(4)(viii)                       5.
 Report)                                   the previous 12 months. This data element will be used
                                           when the term ``for each field'' is used in the CAFO
                                           Annual Program Report
Actual Crop(s) Planted for Each Field     Actual crop(s) planted for each field                     122.42(e)(4)(viii)                       5.
 (Program Report)
Actual Crop Yield(s) for Each Field       Actual crop yield(s) for each field                       122.42(e)(4)(viii)                       5.
 (Program Report)
Actual Crop Yield(s) for Each Field       The unit(s) for the actual crop yield(s) for each field   122.42(e)(4)(viii)                       5.
 Units (Program Report)                    (e.g., bushels per acre)
Method for Calculating Maximum Amounts    The unique code/description that identifies whether the   122.42(e)(4)(viii)                       5.
 of Manure, Litter, and Process            CAFO used the Linear Approach [40 CFR 122.42(e)(5)(i)]
 Wastewater (Program Report)               or the Narrative Rate Approach [40 CFR
                                           122.42(e)(5)(ii)]
CAFO MLPW Land Application For Each       The unique code/description that identifies for each      122.42(e)(4)(viii)                       5.
 Field (Program Report)                    field the type of CAFO manure, litter, and process
                                           wastewater i.e., in the previous 12 months and used for
                                           land application
CAFO MLPW Land Application Maximum        The maximum amount of CAFO manure, litter, and process    122.42(e)(4)(viii)                       5.
 Amount For Each Field (Program Report)    wastewater for each field in the previous 12 months and
                                           used for land application. The maximum amounts of CAFO
                                           manure, litter, and process wastewater is calculated in
                                           accordance with procedures in the Linear Approach [40
                                           CFR 122.42(e)(5)(i)(B)] or the Narrative Rate Approach
                                           [40 CFR 122.42(e)(5)(ii)(D)]
CAFO MLPW Land Application Actual Amount  The actual amount of CAFO manure, litter, and process     122.42(e)(4)(viii)                       5.
 For Each Field (Program Report)           wastewater for each field in the previous 12 months and
                                           used for land application
CAFO MLPW Land Application For Each       The unit (e.g., tons, gallons) for the maximum and        122.42(e)(4)(viii)                       5.
 Field Unit (Program Report)               actual amount of CAFO manure, litter, and process
                                           wastewater for each field in the previous 12 months and
                                           used for land application
Nitrogen Soil Test Measurement            For each field used for land application, the results of  122.42(e)(4)(viii)                       5.
 (Narrative Rate Approach) (Program        the most recent soil nitrogen analysis for any soil
 Report)                                   test taken in the preceding 12 months (i.e., amount of
                                           nitrogen in the soil). This data element is only
                                           applicable to facilities using the Narrative Rate
                                           Approach as described in 40 CFR 122.42(e)(5)(ii)
Phosphorus Soil Test Measurement          For each field used for land application, the results of  122.42(e)(4)(viii)                       5.
 (Narrative Rate Approach) (Program        the most recent soil phosphorus analysis for any soil
 Report)                                   test taken in the preceding 12 months (i.e., amount of
                                           phosphorus in the soil). This data element is only
                                           applicable to facilities using the Narrative Rate
                                           Approach as described in 40 CFR 122.42(e)(5)(ii)
Soil Test Measurement Form (Narrative     The form (e.g., total nitrogen, ammonium-nitrogen, total  122.42(e)(4)(viii)                       5.
 Rate Approach) (Program Report)           phosphorus) for each soil test measurement. This data
                                           element is only applicable to facilities using the
                                           Narrative Rate Approach as described in 40 CFR
                                           122.42(e)(5)(ii)
Soil Test Measurement Unit(s) (Narrative  The unit(s) for the amounts of nitrogen and/or            122.42(e)(4)(viii)                       5.
 Rate Approach) (Program Report)           phosphorus for any soil test results. This data element
                                           is only applicable to facilities using the Narrative
                                           Rate Approach, as described in 40 CFR 122.42(e)(5)(ii)
Nitrogen Amount of Any Supplemental       For each field used for land application, provide the     122.42(e)(4)(viii)                       5.
 Fertilizer Applied (Program Report)       amount of nitrogen in supplemental fertilizer applied
                                           in the previous 12 months. This data element is only
                                           applicable to facilities using the Narrative Rate
                                           Approach as described in 40 CFR 122.42(e)(5)(ii)
Phosphorus Amount of Any Supplemental     For each field used for land application, provide the     122.42(e)(4)(viii)                       5.
 Fertilizer Applied (Program Report)       amount of phosphorus in supplemental fertilizer applied
                                           in the previous 12 months. This data element is only
                                           applicable to facilities that are using the Narrative
                                           Rate Approach as described in 40 CFR 122.42(e)(5)(ii)
Supplemental Fertilizer Applied Units     The unit(s) for the amount(s) of nitrogen and/or          122.42(e)(4)(viii)                       5.
 (Program Report)                          phosphorus in any supplemental fertilizer applied in
                                           the previous 12 months (e.g., ppm, pounds per acre).
                                           This data element is only applicable to facilities
                                           using the Narrative Rate Approach, as described in 40
                                           CFR 122.42(e)(5)(ii)
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              Compliance Monitoring Activity Information (Data Elements Specific to Municipal Separate Storm Sewer System Program Reports)
--------------------------------------------------------------------------------------------------------------------------------------------------------
      [Note: The MS4 permit may require one report for each unique governmental entity or one report per permit].
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MS4 Reliance on Other Government          This is a unique code (e.g., ``Yes'', ``No'') that        122.26(d)(2)(vii), 122.34(g)(3)(v)       6.
 Entities Status                           identifies whether the permittee relies on another
                                           unique governmental entity to satisfy any of the permit
                                           requirements
MS4 Reliance on Other Government          For each MS4 permit component this data element           122.34(g)(3)(i) and (v), 122.35(a) and   6.
 Entities: Permit Component Status         identifies the responsible government entity. This data   122.42(c)
                                           element uses the `Unique Identifier for Each
                                           Municipality Covered Under MS4 Permit' data element.
                                           Use of this identifier allows for greater geographic
                                           resolution for the MS4 components being tracked. This
                                           unique identifier does not change over time. The number
                                           identifies the entity taking responsibility for
                                           complying with each MS4 permit component
MS4 Permit Components Descriptions and    The one or more codes/descriptions that identify for      122.34(g)(3) and 122.42(c)               6.
 Measurable Goals                          each unique municipality all of the permitted
                                           components and measurable goals that are included in
                                           the MS4 permit. For Phase II MS4s, these components
                                           will be pre-populated from the BMPs each Phase II MS4
                                           permittee indicated it will implement in its NOI or
                                           permit application. The groupings of these MS4
                                           components will include public education and outreach
                                           on stormwater impacts; public involvement/
                                           participation; illicit discharge detection and
                                           elimination; construction site stormwater runoff; post-
                                           construction stormwater management in new development
                                           and redevelopment; and pollution prevention/good
                                           housekeeping for municipal operations
Changes to MS4 Permit Components and      The one or more codes/descriptions that describe for      122.34(g)(3)(iv) and 122.42(c)           6.
 Measurable Goals                          each unique municipality any changes made to MS4 permit
                                           components (e.g., BMPs) during the reporting period
Status of Compliance with each Minimum    The unique code (e.g., ``Yes'', ``No'') that identifies   122.34(g)(3) and 122.42(c)               6.
 Control Measure                           if the permittee has completed each measureable goal
                                           associated with each MS4 permit component
Progress and Summary of Results with      This is a text summary describing the permittee's         122.34(g)(3) and 122.42(c)               6.
 Each Minimum Control Measure              compliance and progress toward meeting each measurable
                                           goal including a summary of results for each unique
                                           municipality
MS4 Enforcement Action Type               For each unique municipality covered under a Phase I MS4  122.34(g)(3) and 122.42(c)               6.
                                           permit, this data element identifies the one or more
                                           types of enforcement actions taken during the past
                                           reporting period (e.g., notice of violations, stop work
                                           orders, administration orders, administrative fines,
                                           civil penalties, criminal actions). The unique
                                           municipality covered under the MS4 permit will identify
                                           ``No Authority'' for this data element if the
                                           municipality does not have the authority to conduct
                                           enforcement actions. This data element is optional for
                                           Phase II MS4s
MS4 Enforcement Action Number             For each unique municipality covered under a Phase II     122.34(g)(3) and 122.42(c)               6.
                                           MS4 permit and for each MS4 Enforcement Action Type,
                                           this data element identifies the number of enforcement
                                           actions taken by responsible MS4 Municipal Enforcement
                                           Agency. The unique municipality covered under the MS4
                                           permit will identify ``No Authority'' for this data
                                           element if the municipality does not have the authority
                                           to conduct enforcement actions. For Phase II MS4s this
                                           data element will be the total number of enforcement
                                           actions taken during the reporting period
MS4 Municipality Enforcement Agency       For each unique municipality covered under the MS4        122.34(g)(3) and 122.42(c)               6.
                                           permit and for each MS4 Enforcement Action Type, this
                                           data element identifies the corresponding MS4 Municipal
                                           Enforcement Agency by its unique municipality number
                                           (``Unique Identifier for Each Municipality Covered
                                           Under MS4 Permit''). This data element is only required
                                           for permittees that have co-permittees under their
                                           unique MS4 permit
MS4 Industrial Stormwater Control         The one or more unique codes/descriptions that identify   40 CFR 122.26(d)(2)(i)(A, B, C, E, and   6.
                                           how the MS4 permittee will comply with industrial         F) and 40 CFR 122.26(d)(2)(ii) and
                                           stormwater control requirements, including (at a          (iv)(A)(5) and (iv)(C), 122.42(c)
                                           minimum): (1) Status of the ordinance or other
                                           regulatory mechanism to control the contribution of
                                           pollutants by stormwater discharges associated with
                                           industrial activity, including authority to carry out
                                           all inspection, surveillance and monitoring procedures
                                           necessary to determine compliance and noncompliance,
                                           and including sanctions to ensure compliance; (2)
                                           status of the MS4 permittee industrial stormwater
                                           inventory, which identifies facilities with industrial
                                           activities and assesses the quality of the stormwater
                                           discharged from each facility with an industrial
                                           activity; (3) status of program to monitor and control
                                           pollutants in stormwater discharges from municipal
                                           landfills, hazardous waste treatment, disposal and
                                           recovery facilities, industrial facilities that are
                                           subject to Toxics Release Inventory (TRI) reporting
                                           requirements (Emergency Planning and Community Right-To-
                                           Know Act Section 313), and industrial facilities that
                                           are contributing a substantial pollutant loading to the
                                           MS4; and (4) status of monitoring program for
                                           discharges associated with industrial facilities. This
                                           data element is optional for Phase II MS4s
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  Compliance Monitoring Activity Information (Data Elements Specific to Pretreatment Program Reports, SIU Periodic Compliance Reports in Municipalities
                                                        without an Approved Pretreatment Program)
--------------------------------------------------------------------------------------------------------------------------------------------------------
      [Note: These data elements do not apply to the development, evaluation, or compliance monitoring activities supporting wastewater surcharge
   rates.]
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SNC Published                             A unique code (e.g., ``Yes'', ``No'') that identifies     403.8(f)(2)(viii), 403.12(i)(2)          7.
                                           for each Significant Industrial User (SIU) and Non-
                                           Significant Categorical Industrial Users (NSCIU) in SNC
                                           whether the Control Authority published a public notice
                                           within the reporting period
SNC with Pretreatment Enforceable         The unique code/description that identifies for each      403.8(f)(2)(viii), 403.12(i)(2)          7.
 Compliance Schedule Status                Significant Industrial User (SIU) and Non-Significant
                                           Categorical Industrial User (NSCIU) in SNC whether the
                                           industrial user in SNC is subject to one or more
                                           enforceable compliance schedules within the reporting
                                           period
Local Limits Adoption Date                This is the most recent date on which the Control         122.44(j)(2)(ii), 403.5(c), 403.8(f)(4)  7.
                                           Authority adopted new local limits within the reporting   and (5), 403.12(i)(4)
                                           period. The date must be provided in YYYY-MM-DD format
                                           where YYYY is the year, MM is the month, and DD is the
                                           day. The Control Authority can leave this data element
                                           blank on the Pretreatment Program Report if the Control
                                           Authority did not adopt any new local limits within the
                                           reporting period
Local Limits Evaluation Date              This is the most recent date on which the Control         122.44(j)(2)(ii), 403.5(c), 403.8(f)(4)  7.
                                           Authority completed an evaluation on the potential need   and (5), 403.12(i)(4), 403.8(f)(4)
                                           for local limits within the reporting period. The date
                                           must be provided in YYYY-MM-DD format where YYYY is the
                                           year, MM is the month, and DD is the day. The Control
                                           Authority can leave this data element blank on the
                                           Pretreatment Program Report if the Control Authority
                                           did not evaluate any local limits within the reporting
                                           period
Local Limits Pollutants                   This is the list of the pollutants for which the Control  403.5(c), 403.12(i)(4)                   7.
                                           Authority adopted local limits. The Control Authority
                                           will only need to enter each pollutant once no matter
                                           how many treatment works are managed by the Control
                                           Authority. The Control Authority can leave this data
                                           element blank on the Pretreatment Program Reports if
                                           the Control Authority did not change the pollutants for
                                           which the Control Authority derived local limits
POTW Discharge Contamination Indicator    The one or more unique codes/descriptions that identify   403.8(f), 403.12(i)                      7.
 (Program Report)                          any problems (e.g., pass-through, interference,
                                           violation of NPDES permit limits) with the receiving
                                           POTW's effluent discharge within the reporting period.
                                           See 40 CFR 403.3(k) and (p). EPA regulations require
                                           the Control Authority to develop and enforce local
                                           limits when the discharge from an IU causes or
                                           contributes to any problems at the receiving POTW
POTW Biosolids or Sewage Sludge           The one or more unique codes/descriptions that identify   403.8(f), 403.12(i)                      7.
 Contamination Indicator (Program          any problems (e.g., interference with the use or
 Report)                                   disposal of biosolids or sewage sludge, violation of
                                           NPDES permit requirements or EPA's regulations at 40
                                           CFR part 503) with the receiving POTW's biosolids or
                                           sewage sludge within the reporting period. See 40 CFR
                                           403.3(k). EPA regulations require any Control Authority
                                           that must develop a Pretreatment Program also to
                                           develop and enforce local limits to ensure that the
                                           discharge from an IU does not cause or contribute a
                                           disruption of biosolids' use or disposal at the
                                           receiving POTW
Industrial User Control Mechanism Status  A unique code/description that identifies whether the     403.3(k), 403.5(c), 403.8(f), 403.12(i)  7.
                                           Industrial User is subject to an effective Control
                                           Mechanism within the reporting period
Industrial User Control Mechanism         The date when the active Control Mechanism for the        403.8(f)(1)(iii)(B)(1), 403.12(i)        7.
 Effective Date                            Industrial User became effective. The date must be
                                           provided in YYYY-MM-DD format where YYYY is the year,
                                           MM is the month, and DD is the day
Industrial User Control Mechanism         The date when the active Control Mechanism for the        403.8(f), 403.12(i)                      7.
 Expiration Date                           Industrial User will expire. The date must be provided
                                           in YYYY-MM-DD format where YYYY is the year, MM is the
                                           month, and DD is the day
SNC With Pretreatment Standards or        This data element will identify for each Significant      403.8(f), 403.12(i)                      7.
 Limits (Program Report)                   Industrial User (SIU) and Non-Significant Categorical
                                           Industrial User (NSCIU) whether the IU was in
                                           Significant Non-Compliance (SNC) with any pretreatment
                                           standard or local limits applicable to the industrial
                                           user's discharge within the reporting period
SNC With Pretreatment Standards or        This data element will identify for each Significant      403.8(f), 403.12(i)                      7.
 Limits Pollutants (Program Report)        Industrial User (SIU) and Non-Significant Categorical
                                           Industrial User (NSCIU) the pollutants that related to
                                           the industrial user's Significant Non-Compliance (SNC)
                                           status with any applicable pretreatment standard or
                                           local limits within the reporting period
SNC With Reporting Requirements (Program  This data element will identify for each Significant      123.26, 123.41(a), 123.45, 403.8(f),     1, 7.
 Report)                                   Industrial User (SIU) and Non-Significant Categorical     403.10, 403.12(i)
                                           Industrial User (NSCIU) whether the IU was in
                                           Significant Non-Compliance (SNC) with reporting
                                           requirements (including baseline monitoring reports,
                                           notice of potential problems, periodic self-monitoring
                                           reports, notice of change in Industrial User discharge,
                                           hazardous waste notification and BMP certification)
                                           within the reporting period
SNC with Other Control Mechanism          This data element will identify for each Significant      123.26, 123.41(a), 123.45, 403.8(f),     1, 7.
 Requirements (Program Report)             Industrial User (SIU) and Non-Significant Categorical     403.10, 403.12(i)
                                           Industrial User (NSCIU) whether the IU was in
                                           Significant Non-Compliance (SNC) with any other control
                                           mechanism requirements within the reporting period.
                                           This data element does not include instances of SNC
                                           that relate to the industrial user's applicable
                                           discharge standards or local limits or reporting
                                           requirements
Listing of Months in SNC                  This data element will identify for each Significant      123.26, 123.41(a), 123.45, 403.8(f),     1, 7.
                                           Industrial User (SIU) and Non-Significant Categorical     403.10, 403.12(i)
                                           Industrial User (NSCIU) the month or months the IU is
                                           in SNC within the reporting period. These data must be
                                           provided in YYYY-MM format where YYYY is the year and
                                           MM is the month
Number of Industrial User Inspections by  This data element will identify for each Significant      403.8(f), 403.12(i)                      7.
 Control Authority                         Industrial User (SIU) the number of inspections
                                           conducted by the Control Authority within the reporting
                                           period
Number of Industrial User Sampling        This data element will identify for each Significant      403.8(f), 403.12(i)                      7.
 Events by Control Authority               Industrial User (SIU) the number of complete sampling
                                           events conducted by the Control Authority within the
                                           reporting period
Number of Required Industrial User Self-  This data element will identify for each Significant      403.8(f), 403.12(i)                      7.
 Monitoring Events                         Industrial User (SIU) the number of required self-
                                           monitoring sampling events within the reporting period
                                           that must be reported to the Control Authority
Actual Number of Industrial User Self-    This data element will identify for each Significant      403.8(f), 403.12(i)                      7.
 Monitoring Events                         Industrial User (SIU) the actual number of self-
                                           monitoring sampling events within the reporting period
                                           submitted to the Control Authority
Types of Industrial User Enforcement      This data element will identify for each Significant      403.8(f), 403.12(i)                      7.
 Action                                    Industrial User (SIU) the type(s) of formal enforcement
                                           action(s) (e.g., formal notices of violation or
                                           equivalent actions, administrative orders, civil suits,
                                           criminal suits) issued by the Control Authority within
                                           the reporting period. The Control Authority can also
                                           optionally use this data element to track informal
                                           actions that they issued within the reporting period
Number of Industrial User Enforcement     This data element will identify for each Significant      403.8(f), 403.12(i)                      7.
 Actions                                   Industrial User (SIU) and for each type of enforcement
                                           action the total number of formal enforcement actions
                                           issued by the Control Authority within the reporting
                                           period. The Control Authority can also optionally use
                                           this data element to track informal actions that they
                                           issued within the reporting period
Industrial User Cash Civil Penalty        For civil judicial Enforcement Actions, the dollar        CWA section 309                          7.
 Amount Assessed                           amount of the penalty assessed against each Significant
                                           Industrial User (SIU) and Non-Significant Categorical
                                           Industrial User (NSCIU) within the reporting period as
                                           specified in the final entered Consent Decree or Court
                                           Order. For Administrative Enforcement Actions, it is
                                           the dollar amount of the penalty assessed in the
                                           Consent/Final Order
Industrial User Cash Civil Penalty        For civil judicial Enforcement Actions, the dollar        CWA section 309                          7.
 Amount Collected                          amount of the penalty collected from each Significant
                                           Industrial User (SIU) and Non-Significant Categorical
                                           Industrial User (NSCIU) within the reporting period.
                                           For Administrative Enforcement Actions, it is the
                                           dollar amount collected of the penalty assessed in the
                                           Consent/Final Order
Industrial User POTW Discharge            The one or more unique codes/descriptions that identify   123.26, 123.41(a), 123.45, 403.5(c),     1, 7.
 Contamination Indicator (Program          for each Significant Industrial User (SIU) and Non-       403.8(f), 403.10, 403.12(i)
 Report)                                   Significant Categorical Industrial User (NSCIU) whether
                                           the Industrial User caused or contributed to any
                                           problems (e.g., pass-through, interference, violation
                                           of NPDES permit limits) with the receiving POTW's
                                           effluent discharge in the previous reporting period.
                                           See 40 CFR 403.3(k) and (p). EPA regulations require
                                           the Control Authority to develop and enforce local
                                           limits when the discharge from an IU causes or
                                           contributes to any problems e.g., at the receiving POTW
Industrial User Biosolids or Sewage       The one or more unique codes/descriptions that identify   123.26, 123.41(a), 123.45, 403.5(c),     1, 7.
 Sludge Contamination Indicator (Program   for each Significant Industrial User (SIU) and Non-       403.8(f), 403.10, 403.12(i)
 Report)                                   Significant Categorical Industrial User (NSCIU) whether
                                           the Industrial User caused or contributed to any
                                           problems (e.g., interference with the use or disposal
                                           of biosolids or sewage sludge, violation of NPDES
                                           permit requirements or EPA's regulations at 40 CFR part
                                           503) with the receiving POTW's biosolids or sewage
                                           sludge in the previous reporting period. See 40 CFR
                                           403.3(k). EPA regulations require the Control Authority
                                           to develop and enforce local limits when the discharge
                                           from an IU causes or contributes to any problems e.g.,
                                           at the receiving POTW
Industrial User Wastewater Flow Rate      This data element will identify for each Significant      403.8(f), 403.12(e), 403.12(h),          7, 8.
 (Program Report)                          Industrial User (SIU) and Non-Significant Categorical     403.12(i)
                                           Industrial User (NSCIU) the maximum monthly average
                                           wastewater flow rate (in gallons per day) in the
                                           previous reporting period
Middle-Tier Significant Industrial User   The unique code/description that identifies for each      123.26, 123.41(a), 123.45, 403.10,       1, 7.
 Reduced Reporting Status                  Middle-Tier Significant Industrial User (MTSIU) whether   403.12(e)(3), 403.12(i)(2)
                                           the Control Authority has granted reduced reporting
                                           requirements in accordance with 40 CFR 403.12(e)(3)
Non-Significant Categorical Industrial    The unique code/description that identifies for each Non- 123.26, 123.41(a), 123.45, 403.10,       1, 7.
 User (NSCIU) Certification Submitted to   Significant Categorical Industrial User (NSCIU) whether   403.12(i)(2), 403.12(q)
 Control Authority                         the facility has reported its required annual
                                           compliance certification to the Control Authority
                                           within the reporting period
Notification of Changed Discharge         The unique code (e.g., ``Yes'', ``No'') that identifies   403.8(f), 403.12 (i), 403.12(j)          1, 7.
 Submission                                for each Significant Industrial User (SIU) and Non-
                                           Significant Categorical Industrial User (NSCIU) whether
                                           the Industrial User submitted a notification within the
                                           reporting period to the Control Authority of a
                                           substantial change in the volume or character of
                                           pollutants in their discharge, including the listing or
                                           characteristic hazardous wastes for which the
                                           Industrial User previously submitted notice
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                       Compliance Monitoring Activity Information (Data Elements Specific to Sewer Overflow/Bypass Event Reports)
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      [Note: These data elements apply to sewer overflows and bypass events at POTWs. These data elements do not apply to industrial facilities. This
   report uses the `Permitted Feature Identifier (Compliance Monitoring Activity)' data element to identify the location of each sewer overflow or
   bypass at a permitted feature. Each bypass location should be permitted and have an identifier in the `Permitted Feature Identifier (Permit)' data
   element. This report will also identify the location of each sewer overflow at an unpermitted feature.]
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Sewer Overflow/Bypass Identifier          This data element will allow the reporting of multiple    122.41(l)(4), (6), and (7) and           3, 9.
                                           sewer overflows or bypasses on one report. Each           122.41(m)(3)
                                           individualized sewer overflow or bypass will be given a
                                           unique identifier (e.g., 1, 2, 3, and so on) for each
                                           Sewer Overflow/Bypass Event Report. This field can be
                                           system generated to accommodate one or more individual
                                           sewer overflows or bypasses. If the sewer overflows are
                                           caused by an extreme weather event (e.g., hurricane)
                                           that floods the entire sewer system the POTW can use
                                           this data element to indicate that the number of sewer
                                           overflows cannot be tabulated as they are too numerous
                                           to count
Sewer Overflow Longitude for Unpermitted  This data element is required for each Sewer Overflow/    122.41(l)(4), (6), and (7)               3, 9.
 Feature (Sewer Overflow/Bypass Event      Bypass Identifier without a corresponding identifier in
 Report)                                   the `Permitted Feature Identifier (Permit)' data
                                           element, which is reported on the NPDES permit
                                           application or Notice of Intent for NPDES permit
                                           coverage. This data element is the measure of the
                                           angular distance on a meridian east or west of the
                                           prime meridian for the sewer overflow location. The
                                           format for this data element is decimal degrees (e.g.,
                                           ^77.029289) and the WGS84 standard coordinate system.
                                           The `Permitted Feature Identifier (Compliance
                                           Monitoring Activity)' data element is used to identify
                                           the location of each sewer overflow at a permitted
                                           feature. If the sewer overflow is associated with a
                                           private residence the longitude of the nearest
                                           collection system structure (e.g., manhole) can be used
                                           for this data element to the extent that reporting is
                                           required. The POTW can leave this data element blank on
                                           the Sewer Overflow/Bypass Event Report if the sewer
                                           overflows are caused by an extreme weather event (e.g.,
                                           hurricane) that floods the entire sewer system and are
                                           too numerous to count. This data element can also be
                                           system generated if the Sewer Overflow/Bypass Event
                                           Report collects the street location of the sewer
                                           overflow and the street location can be used to
                                           generate an accurate longitude value. (Note: ``Post
                                           Office Box'' addresses and ``Rural Route'' addresses
                                           are generally not geocodable)
Sewer Overflow Latitude for Unpermitted   This data element is required for each Sewer Overflow/    122.41(l)(4), (6), and (7)               3, 9.
 Feature (Sewer Overflow/Bypass Event      Bypass Identifier without a corresponding identifier in
 Report)                                   the `Permitted Feature Identifier (Permit)' data
                                           element, which is reported on the NPDES permit
                                           application or Notice of Intent for NPDES permit
                                           coverage. This data element is the measure of the
                                           angular distance on a meridian north or south of the
                                           equator for the sewer overflow location. The format for
                                           this data element is decimal degrees (e.g., ^77.029289)
                                           and the WGS84 standard coordinate system. The Permitted
                                           Feature Identifier (Compliance Monitoring Activity)
                                           data element is used to identify the location of each
                                           sewer overflow at a permitted feature. If the sewer
                                           overflow is associated with a private residence the
                                           latitude of the nearest collection system structure
                                           (e.g., manhole) can be used for this data element to
                                           the extent that reporting is required. The POTW can
                                           leave this data element blank on the Sewer Overflow/
                                           Bypass Event Report if the sewer overflows are caused
                                           by an extreme weather event (e.g., hurricane) that
                                           floods the entire sewer system and are too numerous to
                                           count. This data element can also be system generated
                                           if the Sewer Overflow/Bypass Event Report collects the
                                           street location of the sewer overflow and the street
                                           location can be used to generate an accurate longitude
                                           value. (Note: ``Post Office Box'' addresses and ``Rural
                                           Route'' addresses are generally not geocodable)
Type of Sewer Overflow/Bypass (Sewer      A unique code/description that identifies the type of     122.41(l)(4), (6), and (7) and           3, 9.
 Overflow/Bypass Event Report)             sewer overflow or bypass (e.g., CSO or SSO from the       122.41(m)(3)
                                           POTW's collection system, anticipated bypass from the
                                           treatment works, unanticipated bypass from the
                                           treatment works) for each Sewer Overflow/Bypass
                                           Identifier. For bypass events the permittee will also
                                           use this data element to identify if any NPDES effluent
                                           limitations were violated as a result of the bypass
Type of Sewer Overflow/Bypass Structure   A unique code/description that identifies the type of     122.41(l)(4), (6), and (7) and           3, 9.
                                           sewer overflow or bypass structure (e.g., manhole, CSO    122.41(m)(3)
                                           outfall) for each Sewer Overflow/Bypass Identifier. The
                                           POTW can leave this data element blank on the Sewer
                                           Overflow/Bypass Event Report if the sewer overflows are
                                           caused by an extreme weather event (e.g., hurricane)
                                           that floods the entire sewer system and are too
                                           numerous to count
Sewer Overflow/Bypass Cause               The one or more unique codes/descriptions that best       122.41(l)(4), (6), and (7) and           3, 9
                                           represent the likely cause of the sewer overflow or       122.41(m)(3)
                                           bypass (e.g., broken pipe, fats/oil/grease, mechanical
                                           failure, pump station electrical failure, wet weather,
                                           vandalism) for each Sewer Overflow/Bypass Identifier.
Duration of Sewer Overflow/Bypass         Estimated duration of the sewer overflow or bypass (in    122.41(l)(4), (6), and (7) and           3, 9.
 (hours) (Sewer Overflow/Bypass Event      hours) for each Sewer Overflow/Bypass Identifier. If      122.41(m)(3)
 Report)                                   the discharge has not been corrected, this is the best
                                           professional judgment from the sewer owner or in the
                                           case of a bypass, the treatment plant owner, of the
                                           time the sewer overflow or bypass is expected to
                                           continue. The POTW can leave this data element blank on
                                           the Sewer Overflow/Bypass Event Report if the sewer
                                           overflows are caused by an extreme weather event (e.g.,
                                           hurricane) that floods the entire sewer system and are
                                           too numerous to count
Sewer Overflow/Bypass Discharge Volume    Best professional judgment from the sewer owner on the    122.41(l)(4), (6), and (7) and           3, 9.
 (gallons) (Sewer Overflow/Bypass Event    estimated number of gallons of sewer overflow or bypass   122.41(m)(3)
 Report)                                   for each Sewer Overflow/Bypass Identifier. If the
                                           discharge has not been corrected, this is the best
                                           professional judgment from the sewer owner or in the
                                           case of a bypass, the treatment plant owner, of the
                                           volume of overflow or bypass prior to cessation. The
                                           POTW can leave this data element blank on the Sewer
                                           Overflow/Bypass Event Report if the sewer overflows are
                                           caused by an extreme weather event (e.g., hurricane)
                                           that floods the entire sewer system and are too
                                           numerous to count
Receiving Waterbody Name for Unpermitted  This data element identifies the receiving waterbody      122.41(l)(4), (6), and (7)               3, 9.
 Feature (Sewer Overflow/Bypass Event      name for each Sewer Overflow/Bypass Identifier that
 Report)                                   does not have a corresponding value in the `Permitted
                                           Feature Identifier (Permit)' data element. This data
                                           element will use the best professional judgment of the
                                           sewer owner to identify the name of the waterbody that
                                           is or will likely receive the discharge from each Sewer
                                           Overflow/Bypass Identifier. The POTW can leave this
                                           data element blank on the Sewer Overflow/Bypass Event
                                           Report if the sewer overflows are caused by an extreme
                                           weather event (e.g., hurricane) that floods the entire
                                           sewer system and are too numerous to count
Wet Weather Occurrence for Sewer          The unique code (e.g., ``Yes'', ``No'') that represents   122.41(l)(4), (6), and (7) and           3, 9.
 Overflow/Bypass Status                    the best professional judgment of the sewer owner, or     122.41(m)(3)
                                           in the case of a bypass, the treatment plant owner,
                                           regarding whether the sewer overflow or bypass, by
                                           Sewer Overflow/Bypass Identifier, occurred during wet
                                           weather
Corrective Actions Taken or Planned for   The unique code/description that describes the steps      122.41(l)(4), (6), and (7) and           3, 9.
 Sewer Overflow/Bypass (Sewer Overflow/    taken or planned to reduce, eliminate, and prevent        122.41(m)(3)
 Bypass Event Report)                      reoccurrence of future sewer overflows or bypasses for
                                           each Sewer Overflow/Bypass Identifier and the related
                                           impacts to health and the environment. This data
                                           element can be used to identify the portion of the
                                           sewer overflow or bypass that was contained and
                                           recovered prior to any discharge to waters of the U.S.
                                           This data element will also identify if any monitoring
                                           of the receiving waterbody was done during and/or after
                                           the sewer overflow or bypass to gauge the potential
                                           impact to health and the environment. The POTW can
                                           leave this data element blank on the Sewer Overflow/
                                           Bypass Event Report if the sewer overflows are caused
                                           by an extreme weather event (e.g., hurricane) that
                                           floods the entire sewer system and are too numerous to
                                           count
Type of Potential Impact of Sewer         The unique code/description that describes the type of    122.41(l)(4), (6), and (7) and           3, 9.
 Overflow/Bypass (Sewer Overflow/Bypass    potential health or environmental impact(s) (e.g.,        122.41(m)(3)
 Event Report)                             beach closure) for each Sewer Overflow/Bypass
                                           Identifier. Under 40 CFR 122.41(l)(6), ``the permittee
                                           shall report any noncompliance which may endanger
                                           health or the environment.'' This data element provides
                                           information regarding the nature of such potential
                                           endangerment. The POTW can leave this data element
                                           blank on the Sewer Overflow/Bypass Event Report if the
                                           sewer overflows are caused by an extreme weather event
                                           (e.g., hurricane) that floods the entire sewer system
                                           and are too numerous to count
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                        Compliance Monitoring Activity Information (Data Elements Specific to CWA section 316(b) Annual Reports)
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      [Note: Where the Director requires additional measures to protect Federally-listed threatened or endangered species or critical habitat pursuant
   to 40 CFR 125.94(g), the Director shall require reporting associated with those measures [see 40 CFR 125.97(g)]. The following data elements
   correspond to this reporting requirement. These data elements are only required for facilities that are required to report on their additional
   measures to protect Federally-listed threatened or endangered species or critical habitat.]
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CWA Section 316(b) Biological             For existing facilities, a listing of each Federally-     125.96, 125.97(g), 125.98, 125.138(b),   10.
 Monitoring--Species Name (Program         listed threatened or endangered species (or relevant      401.14 and CWA section 316(b)
 Report)                                   taxa) for all life stages that might be susceptible to
                                           impingement and entrainment at the facility's cooling
                                           water intake structure(s). Specific monitoring
                                           protocols and frequency of monitoring will be
                                           determined by the Director
CWA Section 316(b) Biological             For existing facilities, the number of each Federally-    125.96, 125.97(g), 125.98, 125.138(b),   10.
 Monitoring--Species Number (Program       listed threatened or endangered species (or relevant      401.14 and CWA section 316(b)
 Report)                                   taxa) that might be susceptible to impingement and
                                           entrainment at the facility's cooling water intake
                                           structure(s). Specific monitoring protocols and
                                           frequency of monitoring will be determined by the
                                           Director
CWA Section 316(b) Biological             For existing facilities, a unique code/description that   125.96, 125.97(g), 125.98, 125.138(b),   10.
 Monitoring--Threatened or Endangered      identifies for each Federally-listed threatened or        401.14 and CWA section 316(b)
 Status (Program Report)                   endangered species (or relevant taxa) whether the
                                           species is threatened, endangered, or is an otherwise
                                           protected species that might be susceptible to
                                           impingement and entrainment at the facility's cooling
                                           water intake structure(s). Specific monitoring
                                           protocols and frequency of monitoring will be
                                           determined by the Director
CWA Section 316(b) Biological             For existing facilities, the number of each Federally-    125.96, 125.97(g), 125.98, 125.138(b),   10.
 Monitoring--Species Impinged and          listed threatened or endangered species (or relevant      401.14 and CWA section 316(b)
 Entrained (Program Report)                taxa) impinged and entrained per year by the facility's
                                           cooling water intake structure(s). Specific monitoring
                                           protocols and frequency of monitoring will be
                                           determined by the Director
CWA Section 316(b) Biological             For existing facilities, a text summary of the measures   125.96, 125.97(g), 125.98, 125.138(b),   10.
 Monitoring--Applicable Measures to        taken by the permittee to protect designated critical     401.14 and CWA section 316(b)
 Protect Designated Critical Habitat       habitat in the vicinity of impingement and entrainment
 (Program Report)                          at the facility's cooling water intake structure(s)
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                                         Information Common to Violations, Enforcement Actions, and Final Orders
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      [Note: Single Event Violation (SEV) data elements are mandatory for construction stormwater inspections that identify CWA violations that result
   in a regulatory authority taking a formal enforcement action. SEV data elements are optional for other construction stormwater inspections.]
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Violation Code                            The unique code/description that identifies each type of  123.45 and CWA section 309               1.
                                           violation that has occurred at the facility (e.g., D80
                                           = Required Monitoring DMR Value Non-Receipt, E90 =
                                           Effluent Violation, C20 = Schedule Event Achieved
                                           Late). This includes single event violations (SEVs) and
                                           violations that are system generated based upon DMRs,
                                           schedules, etc.
Violation Date                            This is the date of the violation, which varies           123.45 and CWA section 309               1.
                                           depending on the type of violation. The date must be
                                           provided in YYYY-MM-DD format where YYYY is the year,
                                           MM is the month, and DD is the day. This data element
                                           may be system generated and does not apply to single
                                           event violation dates
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                                                                  Violation Information
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Agency Identifying the Single Event       The unique code/description that identifies the agency    123.26, 123.41(a), 123.45                1.
 Violation (SEV)                           that identified the single event violation (SEV)
Single Event Violation Start Date         The date the single event violation (SEV) began. If the   123.26, 123.41(a), 123.45                1.
                                           SEV occurred on one date, this data element is optional
                                           as this date can be system generated to equal ``Single
                                           Event Violation End Date'' when left blank. The date
                                           must be provided in YYYY-MM-DD format where YYYY is the
                                           year, MM is the month, and DD is the day
Single Event Violation End Date           The date the single event violation (SEV) ended. This     123.26, 123.41(a), 123.45                1.
                                           field will be left blank to denote an ongoing or
                                           unresolved SEV. The date must be provided in YYYY-MM-DD
                                           format where YYYY is the year, MM is the month, and DD
                                           is the day
RNC Detection Code                        The unique code/description that identifies the type of   123.26, 123.41(a), 123.45                1.
                                           reportable noncompliance (RNC) detected by the
                                           regulatory authority
RNC Detection Date                        The date that reportable noncompliance (RNC) was          123.26, 123.41(a), 123.45                1.
                                           detected. This date may vary according to the type of
                                           violation detected. The date must be provided in YYYY-
                                           MM-DD format where YYYY is the year, MM is the month,
                                           and DD is the day
RNC Resolution Code                       The unique code/description that identifies the           123.26, 123.41(a), 123.45                1.
                                           reportable noncompliance (RNC) status (e.g.,
                                           noncompliant, resolved pending, waiting resolution,
                                           resolved) for each violation. This data element can be
                                           entered manually or system generated
RNC Resolution Date                       The date reportable noncompliance (RNC) was marked to     123.26, 123.41(a), 123.45                1.
                                           its current resolution status. This data element is
                                           entered manually. The date must be provided in YYYY-MM-
                                           DD format where YYYY is the year, MM is the month, and
                                           DD is the day
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                                                             Enforcement Action Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
      [Note: NPDES authorized programs will only need to share criminal action information with EPA when the criminal case is concluded.]
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Enforcement Action Identifier             The unique identifier for each enforcement action. For    123.27, 123.41(a), and CWA section 309   1.
                                           EPA enforcement actions, this field will be have three
                                           components, each separated by a hyphen (e.g., 04-2014-
                                           4509). These three components are: (1) the EPA Region
                                           responsible for the enforcement action as identified by
                                           the EPA Region code (e.g., 04); (2) the four-digit
                                           fiscal year during which the enforcement action is
                                           initiated (e.g., 2014); and (3) a four-digit, user-
                                           assigned sequence number between 0001 and 9999 (e.g.,
                                           4509). States will be able to use this same structure,
                                           or they will be able to use a different structure of
                                           their choosing provided that the first two characters
                                           of the identifier constitute the state code (e.g.,
                                           Alabama = ``AL'')
Enforcement Action Forum                  This identifies the forum of the formal enforcement       123.27, 123.41(a), and CWA section 309   1.
                                           action (e.g., administrative formal, judicial). This
                                           can be system generated
Enforcement Action Type                   The unique code/description that identifies the type for  123.27, 123.41(a), and CWA section 309   1.
                                           each formal or informal enforcement action. This code/
                                           description identifies, for example, whether the
                                           enforcement action is a civil judicial referral, a
                                           notice of violation, an administrative penalty order,
                                           administrative order, or criminal prosecution
Programs Violated (Enforcement Action)    The unique code/description that identifies each program  123.27, 123.41(a), and CWA section 309   1.
                                           (e.g., pretreatment, biosolids/sewage sludge, MS4s,
                                           Core NPDES program) associated with each enforcement
                                           activity
Enforcement Action Sub-activity Type      A unique code/description that identifies the type for    123.27, 123.41(a), and CWA section 309   1.
                                           each sub-activity associated with each enforcement
                                           activity (e.g., COMPS = compliance achieved, MECDJ =
                                           motion to enforce consent agreement, AHRG =
                                           administrative hearing, AMNCA = amended complaint).
                                           Some of these sub-activities are system required and
                                           some can be system generated. Data on sub-activities
                                           that are not milestones are optional
Enforcement Action Sub-activity           The date on which the sub-activity was completed. This    123.27, 123.41(a), and CWA section 309   1.
 Completion Date                           data element is required for each sub-activity
                                           provided. The date must be provided in YYYY-MM-DD
                                           format where YYYY is the year, MM is the month, and DD
                                           is the day. Some of these dates can be system generated
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                                                                 Final Order Information
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      [Note: These data elements are linked to the ``Enforcement Action Identifier''. NPDES authorized programs will only need to share criminal action
   information with EPA when the criminal case is concluded.]
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Final Order Identifier                    The unique identifier for each final order. This data     123.27, 123.41(a), and CWA section 309   1.
                                           element can be system generated
Final Order Type                          A unique code that identifies the legal process used by   123.27, 123.41(a), and CWA section 309   1.
                                           the authorized NPDES program to settle the enforcement
                                           action (e.g., administrative compliance order, an
                                           administrative penalty order, consent decree, Federal
                                           facility agreement, criminal conviction or plea
                                           agreement)
Final Order Issued/Entered Date           For a judicial enforcement action this is the date the    123.27, 123.41(a), and CWA section 309   1.
                                           Clerk of the Court stamps the document after it is
                                           signed by the presiding Judge. For an administrative
                                           formal enforcement action this is the date the Final
                                           Order was issued. For a criminal enforcement action,
                                           this is the date the sentence was imposed. The date
                                           must be provided in YYYY-MM-DD format where YYYY is the
                                           year, MM is the month, and DD is the day
NPDES Closed Date                         The date of closure for each NPDES final order. The date  123.27, 123.41(a), and CWA section 309   1.
                                           must be provided in YYYY-MM-DD format where YYYY is the
                                           year, MM is the month, and DD is the day
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                                                                   Penalty Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
      [Note: These data elements are linked to the ``Enforcement Action Identifier''. NPDES authorized programs will only need to share criminal action
   information with EPA when the criminal case is concluded.]
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Penalty Amount Assessed                   For civil judicial enforcement actions, the dollar        123.27, 123.41(a), and CWA section 309   1.
                                           amount of the penalty assessed against the defendant(s)
                                           as specified in the final entered Consent Decree or
                                           Court Order. For administrative enforcement actions, it
                                           is the dollar amount of the penalty assessed in the
                                           Consent Decree or Final Order. For criminal enforcement
                                           actions, it is the dollar amount of the fine agreed to
                                           by the defendant or sentenced by the Court and should
                                           include fields for prison time, probation, home
                                           confinement or monitoring periods, restitution, and
                                           special assessments
Penalty Amount Collected                  For civil judicial enforcement actions, the dollar        123.27, 123.41(a), and CWA section 309   1.
                                           amount of the penalty collected from the defendant(s).
                                           For administrative enforcement actions, it is the
                                           dollar amount collected of the penalty assessed in the
                                           Consent Decree or Final Order. For criminal enforcement
                                           actions, it is the dollar amount of the fine paid by
                                           the defendant as well as restitution and special
                                           assessments
Supplemental Environmental Project        The unique identifier for each supplemental               123.27, 123.41(a), and CWA section 309   1.
 Identifier                                environmental project. This data element can be system
                                           generated
Supplemental Environmental Project        The assessed cost, in dollars, of the one or more of the  123.27, 123.41(a), and CWA section 309   1.
 Amount                                    defendant's Supplemental Environmental Projects (SEPs).
                                           This is the dollar amount that is assessed either in
                                           addition to civil penalties or in lieu of civil
                                           penalties. This data element is only required if there
                                           is a SEP and may be entered at a later date when the
                                           data is available
Supplemental Environmental Project        This text field summarizes the Supplemental               123.27, 123.41(a), and CWA section 309   1.
 Description                               Environmental Projects (SEPs) that the respondent has
                                           completed in response to an enforcement action. This
                                           data element is only required if there is a SEP and may
                                           be entered at a later date when the data is available
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                             Compliance Schedule Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
      [Note: These data elements are linked to the ``Enforcement Action Identifier''.]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Compliance Schedule Number                This number that in combination with the Compliance       123.27, 123.41(a), and CWA section 309   1.
                                           Schedule Type and NPDES ID uniquely identifies a
                                           compliance schedule
Compliance Schedule Type                  The unique code/description that identifies the type of   123.27, 123.41(a), and CWA section 309   1.
                                           compliance schedule (e.g., an administrative formal
                                           action = ``A'', a judicial action = ``J'')
Compliance Schedule Description           The unique code/description that identifies each type of  123.27, 123.41(a), and CWA section 309   1.
                                           condition or requirement (e.g., best management
                                           practices plan development) for the compliance schedule
Compliance Schedule Event Code            The unique code/description that identifies each event    123.27, 123.41(a), and CWA section 309   1.
                                           that is added within a compliance schedule
Compliance Schedule Due Date              The date the compliance schedule event is scheduled to    123.27, 123.41(a), and CWA section 309   1.
                                           be completed (i.e., the due date). The date must be
                                           provided in YYYY-MM-DD format where YYYY is the year,
                                           MM is the month, and DD is the day
Compliance Schedule Actual Date           The actual date on which the compliance schedule event    123.27, 123.41(a), and CWA section 309   1.
                                           was completed or achieved. The date must be provided in
                                           YYYY-MM-DD format where YYYY is the year, MM is the
                                           month, and DD is the day
Compliance Schedule Report Received Date  The date the regulatory agency received the report        123.27, 123.41(a), and CWA section 309   1.
                                           required by the compliance schedule report. The date
                                           must be provided in YYYY-MM-DD format where YYYY is the
                                           year, MM is the month, and DD is the day
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes:
(1) The NPDES program authority may pre-populate these data elements and other data elements (e.g., Federal Registry System ID) in the NPDES electronic
  reporting systems in order to create efficiencies and standardization. For example, the NPDES program authority may configure their electronic
  reporting system to automatically generate NPDES IDs for control mechanisms for new facilities reported on a Pretreatment Program Report [40 CFR
  403.12(i)]. Additionally, the NPDES program authority can decide whether to allow NPDES regulated entities to override these pre-populated data.
(2) The data elements in this table conform to EPA's policy regarding the application requirements for renewal or reissuance of NPDES permits for
  discharges from municipal separate storm sewer systems (see 61 FR 41698; 6 August 1996).
(3) The data elements in this table are also supported by the Office Management and Budget approved permit applications and forms for the NPDES program.
(4) These data will allow EPA and the NPDES program authority to link facilities, compliance monitoring activities, compliance determinations, and
  enforcement actions. For example, these data will provide several ways to make the following linkages: linking violations to enforcement actions and
  final orders; linking single event violations and compliance monitoring activities; linking program reports to DMRs; linking program reports to
  compliance monitoring activities; and linking enforcement activities and compliance monitoring activities.

                             [attachment 8]
USDA Comments on Draft Final WPS Rule
Submitted July 8, 2015
USDA Background
    A healthy and strong agricultural workforce is one of the key 
factors in the success of American agriculture. The labor force, 
whether employed in greenhouses, fields, orchards, nurseries, or other 
productive agricultural enterprises, like employees in other 
industries, should be aware of all activities in their workplace, 
particularly when there is potential occupational exposure directly to 
pesticides or their residues, so that they can take appropriate 
measures to minimize those risks. Agricultural employers have a 
responsibility to ensure that people working at an agricultural 
enterprise have the protections of a safe workplace. The accountability 
of worker protection is not one-sided. To be successful, the labor 
force and the employer share equally in the responsibility. USDA 
supports strong agricultural worker protection standards as they are 
essential to successful, modern agriculture.
Comments on EPA Worker Protection Standard Final Rule
    USDA did not reference its comments by page number and line, 
because changing the display settings for the tracked changes in the 
draft final rule USDA received from EPA resulted in varying page and 
line number alignments. To prevent confusion, USDA is referencing its 
comments by unit and subunit number for the preamble, and by section 
and subsection for the draft final rule.
Comments on the Preamble
    1. USDA. The draft final rule has an overall weakness in a number 
of places in the document in the manner in which EPA justifies 
positions it takes in the document. This weakness is a lack of 
evidenced-based scientific data. In these cases, the positions 
presented by EPA could have be greatly strengthened to make the draft 
final rule more compelling in its justification for their proposed 
changes to the 1992 Worker Protection Standards. With the lack of 
evidenced-based scientific data, some of EPA's positions tend to appear 
as opinions rather than factual determinations. Examples of language in 
the draft final rule that demonstrate this lack of evidenced-based 
scientific data are listed below:

          (a) II.D.: ``Even if the lack of quantitative data impairs 
        the reliability of estimates of the total number of chronic 
        illnesses avoided, it is reasonable to expect that the proposed 
        changes to the WPS will reduce pesticide exposure, and thereby 
        reduce the incidence of chronic disease resulting from 
        pesticide exposure.''
          (b) IV.B.2.: ``Although EPA cannot quantify the specific 
        reduction in incidents from any single change to the 
        regulation, taken together, EPA estimates that the final rule 
        will result in an annual reduction of between 540 and 1,620 
        acute, health-related incidents.''
          (c) V.H.2.: ``2. Benefits. While EPA can estimate the costs 
        of the changes to pesticide safety training for workers and 
        handlers, quantifying the benefits is more difficult. 
        Nonetheless, as explained in the NPRM, it is reasonable to 
        expect that more frequent training would lead to better 
        retention of information by workers and handlers, ultimately 
        resulting in fewer incidents of pesticide exposure and illness 
        in workers and handlers, improved decontamination procedures, 
        reduced take-home exposure, and better protection of 
        children.''

    EPA Response. The preamble discusses the best evidence and data 
that are available, including a detailed analysis of occupational 
pesticide incidents for the four most recent years in the SENSOR-
Pesticides database. EPA believes the statements in the preamble--
including the ones USDA cited--are accurate, and that the evidence and 
data adequately support these revisions to the WPS. EPA is not aware of 
any additional data sources that address the specific scenarios covered 
by the regulations and is interested in learning about any evidence-
based scientific data that USDA has seen. EPA's decisions on training 
were based partially on the widely accepted idea that training people 
on worker safety decreases the number of incidents even though there is 
little research in how the training quantitatively translates to fewer 
incidents. As stated in Unit IV.B.2 of the preamble, EPA has seen a 
significant reduction in the number of estimated incidents since the 
1992 rule even though EPA cannot determine the impact of each 
individual requirement in the rule, as well as other changes in 
agriculture, on that reduction in incidents.

    2. Unit IV.B.2. (``Surveillance data'')

    USDA. Consider rewriting to improve clarity. The original statement 
is ``Another example of potentially avoidable exposure is spray drift; 
labeling prohibits application that contacts other persons and handlers 
should be instructed to apply pesticides in a manner that does not 
contact other persons, but incidents continue to occur.'' Consider 
revising to say: ``Another example of potentially avoidable exposure is 
spray drift. Labeling instructs handlers to apply pesticides in a 
manner that does not contact other persons, but incidents continue to 
occur.''
    EPA Response. EPA has made this change to the preamble by revising 
it as follows: ``. . . Another example of potentially avoidable 
exposure is spray drift. l Labeling prohibits application that contacts 
other persons and instructs handlers must to apply pesticides in a 
manner that does not contact other persons, but pesticide drift 
continues to cause exposure incidents.''

    3. Unit V.D. (``Expand the Content of Worker and Handler Pesticide 
Safety Training'')

    USDA. USDA is concerned that the draft final rule does not include 
any estimate for how much additional time, if any, will be required to 
teach the expanded content of Worker and Handler Pesticide Safety 
Training. Without these time estimates, one cannot compare the training 
times for the expanded content for workers or handlers versus the 
typical time needed to teach the current pesticide safety training 
covering specific content. The time required for training is a 
significant driver of costs to effectively implement the draft final 
rule. This apparent increase in training time needed to provide the 
expanded content appears to put in question EPA's marginal costs 
estimates of Impact on Jobs (page 10) of a typical farmworker to 
increase only $5/year and the marginal cost for a more skilled 
pesticide handler to increase only $50 per year. The ``Economic 
Analysis of the Agricultural Worker Protection Standard Revisions'' did 
not dispel this concern, because the analysis was based on the current 
training time of 30 minutes per sessions without an analysis of how 
long the ``expanded'' training sessions will require. This would also 
put into question EPA's estimate (Costs and Benefits of Revisions to 
Pesticide Safety Training, page 53) of $62 to $80 per agricultural 
establishment per year.
    EPA Response. In the Economic Assessment, Unit 3.3.1 Pesticide 
Safety Training, Step 1 Calculate Baseline Costs, EPA provides an 
estimate of 30 minutes for a full training session for workers under 
the current rule. In the second paragraph on page 57, and under Table 
3.3-7 on page 57, EPA provides the estimate of 45 minutes for worker 
safety training with the expanded content, an increase of 15 minutes of 
training time.
    For the handler training baseline, please refer to Table 3.3-3 for 
the estimate of 45 minutes. Handler safety training covers more 
material than worker safety training. EPA estimated that the additional 
content in the final rule will result in an additional 15 minutes for 
handler training, and EPA includes that estimate in the narrative in 
the economic analysis.
    The 15 minute estimate for the increases in worker and handler 
training time is based on the length and content of current training 
videos.

    4. Unit V.H.1. (``Costs and Benefits of Revisions to Pesticide 
Safety Training: Costs'')

    The expanded training is good from a safety standpoint and is 
necessary. However, it does not appear that the economic analysis 
addresses the impact of the time spent for training on worker/handler 
income particularly if the training is performed at the field prior to 
a work day. For many laborers, wages are earn based on their volume of 
work and not on the hours worked. Are they paid for the time spent 
training or does the time spent training significantly impact their 
earned wages for that day?
    EPA Response. EPA does not require employers to pay workers for 
their time spent in training, although some employers do pay workers 
for that time. This is addressed in the EA as follows:

          Training, Step 1 Calculate Baseline Costs: ``Action is 
        required by two actors, the WPS farm, which provides or 
        arranges the training, and the workers, who take the training. 
        We consider these actors separately, although we assume the WPS 
        farm incurs the training costs and implicitly pays the worker 
        to take the training at the same wage he or she earns doing 
        field work. However, some workers may bear the opportunity cost 
        of taking the training. Workers who are hired to harvest fruits 
        and vegetables are often paid by the quantity harvested; thus, 
        time spent in training is time they are not earning pay.''

Because EPA estimates that under the final rule worker training will 
last 45 minutes, workers who are not paid for by the hour would incur 
an average opportunity cost of less than $10 annually due to the 
training requirement.

    5. Unit VII.A.2. (``Hazard Information--Location and Accessibility: 
Final rule'')

    USDA. Please define the term ``valid'' in this context and describe 
how an employer will be able to determine that the request and 
employee's signature is authentic. [In regards to the following 
sentence: ``When the employer is presented a valid request, the 
employer must provide a copy of, or access to, all of the requested 
information that is applicable within 15 working days from the receipt 
of the request.'']
    EPA Response. In this context, the term ``valid'' was used to mean 
the request contains all of the required information. The agricultural 
employer is required to provide the information only when the 
designated representative presents a complete request. However, for 
clarity, EPA will replace ``valid'' with more descriptive language. 
Specifically, the sentence in Unit VII.A.2 has been revised as follows: 
``When the employer is presented a valid request that contains all of 
the necessary information specified in the regulations, the employer 
must provide a copy of, or access to, all of the requested information 
that is applicable within 15 working days from the receipt of the 
request.''
    The employer will have access to the employee's signature in 
training records. The pesticide use information is not confidential 
Personally Identifiable Information, and it should be readily provided 
to anyone with a plausible claim to be a designated representative. See 
 170.401(d)(1) for details.

    6. Unit VII.B.3. (Paragraph on ``Comments on inconsistencies in 
information between labels and SDSs'')

    It is surprising that EPA is not acknowledging that it is common 
for SDSs to show PPE requirements that are different from the pesticide 
labels, since the two documents are intended for different audiences. 
EPA states here that since the label is not required to be posted, they 
do not ``expect issues with a perception of conflict between labeling 
and SDSs.'' USDA questions whether this is correct. Many Forest Service 
employees have reported finding differences between the PPE listed in 
the SDSs compared to the label. At a minimum, EPA should address this 
issue in the preamble.
    EPA Response. EPA's intention with requiring agricultural employers 
to display the Safety Data Sheets (SDSs) is to provide farmworkers and 
handlers with information regarding chronic, developmental and 
reproductive toxicity that is usually found on SDSs and not the label. 
Much of the technical information on SDSs, such as the chemical and 
physical properties of the pesticide, is designed for use by multiple 
professionals such as manufacturers, transporters, medical personnel 
and firefighters.
    EPA maintains our position that we do not anticipate issues with a 
perception of conflict between labeling and SDSs. First, many SDSs 
include a reference to the pesticide label in the section on exposure 
controls and personal protection. Second, the persons who would wear 
PPE are handlers who are trained that they must follow labeling 
instructions, including those regarding PPE. However, EPA has amended 
the preamble to clarify that pesticide applicators and handlers must 
always follow the instructions on the labeling regardless of any 
differences between information on the labeling and the SDS, and will 
make a point of including in future training materials warnings against 
reliance on SDS provisions regarding PPE.
    EPA has adjusted the response to this comment in Unit VII.B.3 of 
the preamble as follows: ``. . . The SDS provides succinct information 
about the known health hazards of the product that typically is not 
presented as part of the product label or labeling. Such information 
can be invaluable to medical professionals for the diagnosis and 
treatment of certain pesticide-related illnesses and injuries. Because 
EPA is not requiring the employer to display the labeling, EPA does not 
expect issues with a perception of conflict between labeling and SDSs. 
The persons who would wear PPE are handlers who receive more thorough 
training than ordinary workers. If pesticide handlers encounter 
conflicting information on labeling and SDSs, such as the PPE 
identified, they should know that they must follow the instructions on 
the pesticide labeling, as they are trained to do. For information on 
OSHA's adoption of the Globally Harmonized System of Classification and 
Labeling of Chemicals for SDSs and the pesticide product labeling . . 
.''

    7. Unit XVIII.E. (``Equivalency provisions'' and 
``Clarifications'')

    There are two subsections labeled ``E.'' The second one, ``E. 
Clarifications'' should be relabeled ``F. Clarifications''.
    EPA Response. The correction has been made.

    Comments on the Rule 8.  170.305

    a. USDA. The definition for ``agricultural plant'' depends on the 
definition for ``commercial production,'' and the definition for 
``commercial production'' depends on the definition for ``agricultural 
plant.'' Similar issues exist in the definitions of ``agricultural 
establishment'' and ``farm,'' ``forest operation,'' and ``nursery.'' 
USDA recommends resolving these circular dependencies by defining at 
least one of the terms in each pair independently.
    EPA Response. EPA agrees that these definitions are somewhat 
circular, and while EPA is not convinced that serious confusion would 
result, EPA has eliminated some definitions and revised others to 
address USDA's concern. The terms ``commercial production,'' ``farm,'' 
``nursery,'' and ``forest operation'' appear only in the definition 
section and are not used elsewhere in the regulation. Accordingly, EPA 
will delete these definitions and merge their substantive content into 
the definitions of ``agricultural establishment'' and ``agricultural 
plant,'' as follows:

          ``Agricultural establishment'' means any farm, forest 
        operation, or nursery engaged in the outdoor or enclosed space 
        production of agricultural plants. An establishment that is not 
        primarily agricultural is an agricultural establishment if it 
        produces agricultural plants for transplant or use (in part or 
        their entirety) in another location instead of purchasing the 
        agricultural plants. ``Agricultural plant'' means any plant, or 
        part thereof, grown, maintained, or otherwise produced for 
        commercial purposes, including growing, maintaining or 
        otherwise producing plants for sale or trade, for research or 
        experimental purposes, or for use in part or their entirety in 
        another location. ``Agricultural plant'' includes, but is not 
        limited to, grains, fruits and vegetables; wood fiber or timber 
        products; flowering and foliage plants and trees; seedlings and 
        transplants; and turf grass produced for sod. ``Agricultural 
        plant'' does not include pasture or rangeland used for grazing.

    b. USDA. The definition of ``handler employer'' is very broad, 
because it includes both agricultural employers and commercial 
pesticide handler employers (CPHEs), even in a situation where both are 
simultaneously present on the agricultural establishment. This causes 
significant concerns and confusion as to who is ultimately responsible 
for providing the protections in Subpart F (see additional comments on 
Subpart F below).
    As currently written, a ``handler employer'' is anyone who employs 
any handler, as well as self-employed handlers. The definition of 
``handler employer'' uses the verb ``to employ,'' which is also defined 
in  170.305, as ``to obtain, directly or through a labor contractor, 
the services of a person in exchange for a salary or wages . . . 
without regard to who may pay or who may receive the salary or wages'' 
(emphasis added). This definition in turn uses the term ``labor 
contractor,'' whose definition would include any CPHE hired by an 
agricultural employer to provide handlers. Reading these definitions 
together, it becomes clear that agricultural employers can be ``handler 
employers'' even when they do not directly employ a single handler, 
because they are employing handlers through a labor contractor/CPHE.
    In a situation where an agricultural employer hires a CPHE, who in 
turn hires handlers, both the agricultural employer and the CPHE meet 
the definition of ``handler employer,'' since both employ handlers 
under the WPS definition of ``employ'': the CPHE does so ``directly,'' 
while the agricultural employer does so ``through a labor contractor'' 
(i.e., the CPHE). In other words, a handler that is directly employed 
by a commercial pesticide employer handler is simultaneously 
``employed'' by both the CPHE and the agricultural employer, leading to 
confusion over who has ultimate responsibility.
    A solution to this problem would be to change the definition of 
``labor contractor'' to explicitly exclude CPHEs: ``Labor contractor 
means a person, other than a commercial pesticide handler employer, who 
employs workers and handlers to perform tasks . . . '' [The reference 
to handlers in the definition for ``labor contractor'' could then be 
eliminated, since any person employing handlers is a CPHE, and no 
longer a labor contractor.] For handlers, this change would have the 
practical effect of limiting the meaning of the word ``employ'' to just 
a direct employment relationship. As a result, each handler would only 
have a single handler employer (i.e., his or her direct employer). For 
workers who are not handlers, agricultural employers would still 
``employ'' anyone engaged directly or through a labor contractor.
    EPA Response. EPA agrees that the current definitions of labor 
contractor and commercial pesticide handler employer contain some 
problematic language that could result in potential confusion and/or 
conflict regarding agricultural employer and commercial pesticide 
handler employer duties under the rule. EPA has made the suggested 
changes to the final rule with minor modifications to address the fact 
that some labor contractors do bring handlers on to agricultural 
establishments. EPA believes the revised text below clarifies that 
CPHEs are responsible for the handlers they employ and agricultural 
employers would no longer be considered employers of CPHE handlers for 
the purposes of the WPS, without overlooking the fact that some 
handlers are hired by agricultural employers through labor contractors 
and not CPHEs.
    Commercial pesticide handler employer means any person, other than 
an agricultural employer, who employs any handler to perform handler 
activities on an agricultural establishment. A labor contractor who 
does not provide pesticide application services or supervise the 
performance of handler activities, but merely employs laborers who 
perform handler activities at the direction of an agricultural or 
handler employer, is not a commercial pesticide handler employer.
    Employ means to obtain, directly or through a labor contractor, the 
services of a person in exchange for a salary or wages, including 
piece-rate wages, without regard to who may pay or who may receive the 
salary or wages. It includes obtaining the services of a self-employed 
person, an independent contractor, or a person compensated by a third 
party, except that it does not include an agricultural employer 
obtaining the services of a handler through a commercial pesticide 
handler employer or a commercial pesticide handling establishment.
    Labor contractor means a person, other than a commercial pesticide 
handler employer, who employs workers or handlers to perform tasks on 
an agricultural establishment for an agricultural employer.
    c. USDA. USDA is further concerned that EPA's definitions of 
``employ'' and ``agricultural employer'' are not consistent with common 
legal definitions of these terms. Common law, tax law, and certain 
court decisions interpreting related statutes such as the Fair Labor 
Standards Act and the Seasonal Agricultural Worker protection Act, 
Aimable v. Long and Scott Farms, 20 F.3d 434 (1994), make a clear 
distinction between an employer/employee relationship and other, less 
direct working arrangements, such as independent contractors. USDA 
encourages EPA to assign WPS responsibilities in accordance with these 
more traditional and accepted definitions of ``employer'' and ``to 
employ''.
    EPA Response. EPA disagrees. EPA acknowledges that its use of the 
term ``employ'' in the WPS is more aligned with popular usage than with 
the common law and tax law uses of the term, but notes that the 
definition of ``agricultural employer'' in the existing WPS has been 
used since 1992 without significant conflict or confusion with similar 
terms. USDA's objection pertains to the existing WPS definition of 
``agricultural employer'' to the same degree as it does to the draft 
final rule's definitions of ``employ'' and ``agricultural employer,'' 
and EPA declines to change this fundamental and longstanding WPS 
principle.
    d. USDA. EPA included in the definition of ``outdoor production'' 
the phrase ``. . . or in the case of forest operations, a natural 
forest''. Ignoring the question of what an ``unnatural'' forest would 
be, USDA is unsure why this phrase is needed at all. As this is written 
one could say that any planted forest is then not subject to WPS. There 
are other occurrences in the preamble (pages 202, 204, and perhaps 
others).
    EPA Response. EPA agrees that the inclusion of the term ``natural 
forest'' in the definition of ``outdoor production'' creates confusion 
and is not needed. EPA has made the following change to the definition 
of ``outdoor production'' to address USDA's comments:
    Outdoor production means production of an agricultural plant in an 
outside area that is not enclosed or covered in any way that would 
obstruct the natural air flow.
    e. USDA. In addition, most golf courses have nursery greens located 
next to, or near, the golf course. Posting agricultural exclusion 
zones, etc. could disrupt golfing activities. USDA requests 
clarification of how nursery greens are considered. If they are covered 
by this rule, did EPA consider the costs to golf courses which may have 
nurseries?
    EPA Response. Golf courses that have operations considered 
nurseries on their establishment (e.g., they are growing turf/greens in 
a nursery area for use in replacing turf on the playing areas of the 
golf course, or they are growing ornamentals in a greenhouse for 
planting on the golf course) have always been covered by the WPS, and 
compared to the existing WPS, the coverage of golf courses that have 
nurseries on their establishment is not changed by the amendments in 
this final rule. EPA has included an excerpt from the 1995 WPS guidance 
which clarifies this coverage below. Since there are no posting 
requirements associated with application exclusion zones, EPA does not 
see this as an issue. Additionally, EPA understands that most golf 
course pesticide applications are conducted when the public is not 
using the course, and this should be similar with applications to a 
nursery operation on the golf course. EPA expects this practice should 
minimize any potential impact to golf course operations due to WPS 
requirements. EPA considered the cost to golf courses that operate 
nurseries; the costs would be accounted for under the costs of the WPS 
revisions on nursery operations.
  14-24  Production of agricultural plants for other than direct sale
          IGW Question: What is the scope of the WPS with respect to 
        establishments producing agricultural plants for other than 
        direct sale, i.e., in-house use?
          IGW Answer: There is no exception for agricultural plants 
        produced for other than direct sale, i.e., in-house use. The 
        WPS covers an agricultural establishment if (1) a WPS-labeled 
        agricultural pesticide is used on the establishment, (2) 
        workers or handlers are employed by or on the agricultural 
        establishment, (3) the establishment is a farm, forest, 
        nursery, or greenhouse, as defined in the WPS, and (4) the 
        establishment or the activity is not covered by one of the 
        exceptions specifically described in the rule, Section 170.102 
        (b).
          For instance, the following operations are covered by the 
        WPS: Production of hay or feed grown for livestock on dairy 
        farms, cattle ranches, or other livestock operations; sod 
        farms, greenhouses, or nurseries operated by golf courses; and 
        greenhouses and nurseries operated by theme parks, hotel 
        chains, botanical gardens, and state and local governments. 
        (Note: Pasture and rangeland used for grazing are excluded.) 
        (March 15, 1995)

    f. USDA. Including ``arranging for the application of the 
pesticide'' in the definition of ``use, as in `to use a pesticide' '' 
is superfluous and gives the impression of expanding the WPS--and the 
related state enforcement actions--far beyond the actual agricultural 
establishment to reach off-site administrators involved only in pre-
application tasks. USDA recommends removing the reference to 
``arranging for the application of the pesticide.''
    EPA Response. EPA also received several similar comments from 
states, growers, agricultural associations and pesticide manufacturer 
associations objecting to the proposed definition of ``use.'' Most 
commenters objected to the definition of use because they did not 
support inclusion of ``arranging for application of the pesticide'' as 
part of the definition of ``use,'' and they said they believed that 
this language would greatly expand the scope of the WPS and would be 
unreasonable and unnecessary. EPA disagrees with comments that say the 
proposed definition for the term ``use'' could or will expand the scope 
of the WPS because this language has been in  170.9(a) of the WPS 
since the rule first became effective in 1992. Moreover, EPA has not 
been made aware of any instances where this definition of ``use'' has 
resulted in an unreasonable or inappropriate outcome. EPA believes that 
``arranging for application of the pesticide'' is appropriately part of 
the definition of ``use'' for the purposes of the WPS because in 
production agriculture, the individual who physically ``uses'' a 
pesticide almost always does so at the direction of another person who 
has substantially greater control over the circumstances of the use. 
Thus the WPS is designed so that when an agricultural or handler 
employer arranges for the application of a pesticide by a handler 
employee, it triggers certain WPS duties that are properly the 
responsibility of the agricultural or handler employer. For instance, 
once the agricultural employer arranges for a pesticide application by 
a commercial pesticide handling establishment, the commercial pesticide 
handler employer must provide the agricultural employer with certain 
information about the intended application before the application takes 
place (so the employer will be able to fulfill WPS notification 
requirements and protect workers during application, etc.). In such 
circumstances, it is reasonable and appropriate that the handler 
employer should be held responsible for the pre-application information 
exchange even though the application has not commenced and even though 
the handler employer personally never physically applies the pesticide. 
Therefore, since EPA has not been made aware of any instances where the 
existing interpretation of the term ``use'' has resulted in 
unreasonable difficulties for growers, states or the agricultural 
industry, EPA has moved the definition for the term ``use'' into the 
definitions section of the rule without any changes from the proposal.
    8.1 ``Administration of Conservation Programs'' was not included in 
the proposed rule. This NAICS code includes the administration of 
recreational areas and weather forecasting administration, geologic 
survey program administration, preservation of natural resources, 
recreational areas, erosion control, etc. USDA would like an expansion 
on the rationale for their inclusion into the worker protection 
standard. Furthermore, the entirety of this NAICS code's government 
population, appears not to be addressed in the Economic Analysis and, 
therefore, the impact on this sector may not have been included.
    EPA Response. EPA did not receive comments from the entities listed 
under this NAICS code, and does not believe that the WPS applies to 
them. EPA has removed the reference from the preamble, per USDA's 
request.

    9.  170.309(c) and  170.313(c)  minimum age

    USDA. As in previous reviews, USDA opposes changing the minimum age 
for handlers and early-entry workers proposed by EPA and defer this 
decision to the States. U.S. agricultural workers operate under a 
variety of Federal requirements, including those of the Environmental 
Protection Agency and the U.S. Department of Labor. States also have 
minimum age requirements for users of pesticides. The U.S. Department 
of Labor has already set Federal minimum age limits for people who are 
18 years old or younger when working with pesticides. The current 
regulatory system allows for States to increase age requirements and 
most states have already exercised this right based on their unique 
circumstances. USDA believes the current Federal-state system is 
working in this regard. The need for added regulation is not apparent 
and should be weighed against state discretion and current state and 
Federal laws.
    Please see the following as posted by the Department of Labor at 
http://www.dol.gov/elaws/esa/flsa/docs/hazag.asp. (Italics added for 
emphasis.)
  Prohibited Occupations for Agricultural Employees
          The child labor rules that apply to agricultural employment 
        depend on the age of the young worker and the kind of job to be 
        performed. The rules are the same for all youth, migrant 
        children as well as local resident children. In addition to 
        restrictions on hours, the Secretary of Labor has found that 
        certain jobs in agriculture are too hazardous for anyone under 
        16 to perform.

     Once a young person turns 16 years old, he or she can do 
            any job in agriculture.

     A youth 14 or 15 years old can work in agriculture, on any 
            farm, but only in non-hazardous jobs. ? A youth 12 or 13 
            years of age can only work in agriculture on a farm if a 
            parent has given written permission or if a parent is 
            working on the same farm as his or her child, and only in 
            non-hazardous jobs.

     If the youth is younger than 12, he or she can only work 
            in agriculture on a farm if the farm is not required to pay 
            the Federal minimum wage. Under the FLSA, ``small'' farms 
            are exempt from the minimum wage requirements. ``Small'' 
            farm means any farm that did not use more than 500 ``man-
            days'' of agricultural labor in any calendar quarter (3-
            month period) during the preceding calendar year. ``Man-
            day'' means any day during which an employee works at least 
            one hour. If the farm is ``small,'' workers under 12 years 
            of age can only be employed with a parent's permission and 
            only in non-hazardous jobs.
  Hazardous Occupations
     The Secretary of Labor has found that the following 
            agricultural occupations are hazardous for youths under 16 
            years of age. No youth under 16 years of age may be 
            employed at any time in any of these hazardous occupations 
            in agriculture (HO/A) unless specifically exempt. 
            Exemptions (*) will apply to HO/A #1 through #6 under 
            limited circumstances. (None of the exemptions apply to 
            pesticides.)

       HO/A #9 Handling or applying agricultural chemicals if 
            the chemicals are
              classified under the Federal Insecticide, Fungicide and 
            Rodenticide Act as
              Toxicity Category I--identified by the word ``Danger'' 
            and/or ``Poison'' with
              skull and crossbones; or Toxicity Category II--identified 
            by the word ``Warn-
              ing'' on the label. (Handling includes cleaning or 
            decontaminating equip-
              ment, disposing of or returning empty containers, or 
            serving as a flagman
              for aircraft applying agricultural chemicals.)

USDA requests that EPA work with DOL to unify their regulations so that 
those working in agriculture have clear guidance as to Federal minimum 
age requirements for agricultural workers. The States have regulations 
in place that are consistent with DOL--or more restrictive--based on 
the needs of individual States.
    EPA Response. EPA notes that a majority of the comments received 
encouraged the Agency to implement a minimum age of 18 for handlers and 
early-entry workers.
    EPA welcomes input from DOL to ensure no avoidable conflict between 
the WPS and FLSA. However, the statutory criteria for regulating under 
FIFRA and the child labor provisions of FLSA are different. While EPA 
will defer to DOL regarding the scope of its authority under FLSA, it 
does not appear that DOL has the discretion to use the FLSA section 12 
child labor provisions to protect children 16 or older working in 
agriculture. FIFRA does not contain such a limitation, and EPA believes 
that pesticide handling in agriculture and entry to a treated area when 
a restricted-entry interval (REI) is in effect (``early-entry 
workers'') by persons under the age of 18 is inconsistent with the 
FIFRA statutory standard.
    Moreover, where DOL exercises its FLSA child labor authorities in 
regard to children employed in agriculture, its focus is on protecting 
the child worker (see 29 U.S.C. 213(c)(4)). EPA's mandate under FIFRA 
is significantly broader, requiring EPA to prevent unreasonable adverse 
effects of pesticides to workers, other persons, and the environment, 
and these are put at risk when agricultural pesticides are applied by 
persons with immature judgment and risk-taking behaviors. Inasmuch as 
FLSA and FIFRA have different purposes and different scopes, it is not 
surprising that they should produce different regulatory outcomes.
    DOL's standard and the WPS differ in the types of pesticides 
covered. DOL's restrictions on pesticide use in agricultural employment 
applies only to pesticides with high acute toxicity (toxicity 
categories I and II). The WPS applies to all agricultural use 
pesticides, some of which may pose a variety of other risks. Pesticides 
that are extremely toxic to other species, or that are powerful 
carcinogens or mutagens, may nevertheless have low acute human 
toxicity, and therefore be classified in toxicity categories III and 
IV. Such pesticides can pose significant risks to the handler, 
bystanders, and the environment if not used properly.
    To the extent that DOL's standard does protect children from 
agricultural pesticides, it only protects children as pesticide 
applicators. DOL's standard does not cover early-entry workers at all, 
though they face increased risks from entering an area treated with 
pesticides before the residue levels have fallen to a level unlikely to 
cause unreasonable adverse effects.
    In sum, EPA disagrees with USDA's request that EPA should defer to 
the states or the FLSA and not establish any age-related restrictions 
on pesticide handling or early-entry activities. EPA has the 
responsibility under FIFRA to regulate the use of pesticides to avoid 
unreasonable adverse effects, apart from any requirements established 
by other Federal or state laws.

    10.  170.311(b)(6)

    a. USDA: The new requirement to maintain application information 
and SDSs for 2 years is onerous and without foreseeable benefit. Acute 
toxic effects would be the most likely triggering need to get this 
information to a worker. EPA should have considered a longer 
application information posting time (45 days, 60 days) rather than a 
2-year record retention.
    EPA Response. EPA believes that workers in agriculture and 
pesticide regulatory agencies should have access to application and 
exposure information, and believes that two years is a reasonable 
compromise between access and the burdens of record retention. Acute 
pesticide illnesses are the most common triggering effects; however, 
chronic illnesses are potentially linked to pesticide exposure, and 
workers and handlers may present such illnesses and should have access 
to the exposure or hazard information. Under OSHA, records of exposure 
to hazardous chemicals are required to be retained for 30 years, and 
access to those must be provided to workers, even if they are no longer 
employed by the employer. Once the record is created and filed, there 
is little cost to maintaining it. In addition, employers may choose to 
keep the information at the central posting display for the required 
retention period of two years from the date of application, providing 
that the information remains legible and all other requirements are 
met.
    b. USDA: USDA expresses concern over the increased burden placed on 
agricultural employers due to a significant expansion and complexity of 
record-keeping requirements. As written, agricultural employers will 
bear the sole responsibility in providing records and responses to 
workers, their designated representatives, plus states and Federal 
enforcement. Agricultural employers already must keep records under 
OSHA, including The Migrant and Seasonal Agricultural Worker Protection 
Act (MSPA), Field Sanitation Standards under the Occupational Safety 
and Health Act, and Agricultural Employers under the Fair Labor 
Standards Act (FLSA). USDA is further concerned over agricultural 
employers' liability resulting from small procedural mistakes stemming 
from the added recording-keeping requirements under FIFRA.
    EPA Response. EPA responded to comments from agricultural interests 
opposing the proposed record-keeping on the basis of burden by 
examining the purpose and need for the records. As a result, EPA 
eliminated from the final rule the requirement for documenting oral 
notification to workers for early-entry. The review found that 
collection of the application information and the SDS are necessary for 
hazard communications. The remaining records were found to be necessary 
for employers to demonstrate compliance with aspects of the regulation.
    USDA expresses concern for employers' liability from small 
procedural mistakes. Small procedural mistakes are typically addressed 
with a warning notice, rather than monetary penalties. After 
implementation, there will be a period of compliance assistance. During 
this period, EPA and state regulatory agencies will work with 
agricultural interests to ensure understanding of the rule requirements 
and how to comply with them, thereby minimizing ``small procedural 
mistakes.''
    c. USDA. Under OSHA, there are already considerations for 
``designated representatives'' for farm accidents, farm chemical 
hazards, wages, etc. which can be confusing if there is a separate 
``designated representative'' under FIFRA for pesticide hazard 
communication records. OSHA provides a process for expiration, 
revocation of ``designated representatives,'' and whether the 
designated representative can be a union representative, worker group 
representative, etc. for records and in what circumstances the 
designated representative can accompany an inspection. The WPS language 
does not specify how many authorized representatives a worker may have. 
The time to process multiple authorizations, confirm signatures and 
make changes will incur added costs to agricultural employers and 
should be included in the Economic Analysis.
    EPA Response. EPA believes the WPS final rule is clear regarding 
the identification and function of the designated representative. The 
representative must provide, in writing, the designation from the 
worker or handler. The information that the employer must provide is 
limited to the application records and the SDS that were displayed 
while the worker or handler was on the establishment. EPA's designated 
representative requirement is modeled on OSHA's rule at 29 CFR 
1910.1020. EPA is aware that California and Texas regulations include 
employee representatives' access to information for farmworkers. 
Comments from the Texas Department of Agriculture encouraged EPA to 
require the designation in writing and to limit access to records to 
the timeframe of 2 years.
    Under the final rule, while a worker may have multiple authorized 
representatives, EPA expects a single individual could be the 
designated representative under both sets of regulations, thereby 
minimizing confusion and burden for the employer. The final rule does 
not provide access to inspections for the designated representative.
    The Economic Analysis has been updated to provide an estimate of 
the costs of processing requests on a per-request basis, and includes 
the cost of verifying the validity of the request. Please refer to 
comment #30 for details.
    d. USDA. USDA believes the total costs for record-keeping should 
include the following: set-up costs to establish a record-keeping 
system (if one has not already been established; costs to develop 
internal record forms; printing costs for paper records); computer 
software/system costs (for electronic records); storage costs; disposal 
costs of records with sensitive information; maintenance costs for 
records beyond the two-year minimum for longer-term employees. Did EPA 
consider all these in its cost estimates for record-keeping, especially 
for small businesses and government agencies?
    EPA Response. As USDA noted previously in this comment (10.b.), 
agricultural employers must comply with record-keeping under 
requirements from other Federal agencies. Therefore, EPA believes that 
establishments will have record-keeping systems in place as a result of 
complying with the cited requirements. EPA estimates the following 
costs: paper, time to collect information and signatures, and storage. 
The records required by EPA do not include information that would 
ordinarily be considered private or sensitive (note that the draft 
final rule does not require employers to record workers' birthdates), 
therefore, there is no need to dispose of those in any particular 
manner. Finally, as there is not a requirement to retain records beyond 
the two year timeframe regardless of a worker or handler's continued 
employment, such cost is not necessary to assess.

    11.  170.311(b)(7)-(9)

    a. USDA. Compared to the proposed rule's ``authorized 
representative,'' EPA has now coined and defined the term ``designated 
representative'' and added additional language. Regardless of terms, 
EPA's definition of ``designated representative'' still raises serious 
concerns for USDA. We also remind EPA of the concerns expressed by key 
stakeholders that are detailed below in response to reading the 
proposed rule. USDA is concerned that EPA has not seriously considered 
their concerns. We also note that there was only one public comment in 
support of this concept during the proposed rule period which was far 
outnumbered by those written in opposition.

    Minor Crop Farmer Alliance (MCFA)

    ``The current proposed definition of `authorized representative' is 
overly broad and would be very difficult to manage to ensure 
information that is worker specific is protected. The information 
necessary to provide support for workers who seek treatment for 
potential health related impacts is already provided in the current WPS 
regulations. The proposed definition is open-ended and subject to 
serious abuse. The representative of a worker seeking information under 
the provision of the WPS should be limited to family members or medical 
personnel with a legitimate need for information.''

    National Association of State Departments of Agriculture (NASDA)

     ``Authorized representative: We request EPA remove `Authorized 
representative' from the proposed rule. We recognize at least one state 
has this provision included in its state regulations, and we understand 
the inclusion has led to a range of complications and on-going 
litigation that does nothing to forward the purpose of the WPS or 
facilitate a sound regulatory framework. If mandated in the Code of 
Federal Regulations, the new provision will lead to numerous 
complications for both the state regulatory agency and the regulated 
community in trying to comply with the proposed WPS rule, even if the 
designation is required in writing, while protecting against liability 
in responding to fraudulent claims or interests seeking to utilize this 
provision for non-WPS purposes. We oppose this proposal.''

    Association of American Pesticide Control Officials (AAPCO)

    ``Authorized employee representative--A person designated by the 
worker or handler, orally or in writing, to request and obtain any 
information that the employer is required to provide upon request to 
the worker or handler.
    AAPCO does not support the definition as proposed. An authorized 
representative should be designated in writing for a specific worker or 
handler and for a specific event or time period within the last 2 years 
from the date of request (due to record retention requirements). The 
information required to be provided to the authorized representative, 
and the purpose of the request or intended use of the information, 
should be clearly specified as noted in the above comments.''
    EPA [R]esponse. In response to the many comments concerning the 
identification of the designated (authorized) representative, EPA has 
clarified the requirements for the designation: it must be in writing, 
include the name and signature of the requesting employee, describe the 
specific information being requested, the date of the designation, and 
directions for sending the information if so desired. These 
requirements largely meet the AAPCO recommendation. In addition, the 
employer has 15 days to provide the information. EPA believes requiring 
the identification of the designated representative in writing 
addresses the concerns raised for the legitimacy of the designated 
representative and clarity of the request, while continuing to allow 
access to important pesticide exposure information for workers and 
handlers that they may be reluctant to request of their employer.
    One public comment states that the emergency provisions of the 
current rule provide adequate support for workers. However, under the 
rule, only employees seeking emergency assistance while on the 
establishment are so protected. Additionally, employees should have 
access to the information if they are concerned for their exposure but 
do not show symptoms.
    USDA states that only a single public comment supports the 
authorized representative concept; however, EPA has found several 
comments in support of the authorized representative, stating that the 
requirement would enable a worker or handler access to important 
information for medical purposes.

    b. USDA has the following additional comments on this section

    These requirements for providing application data to the worker or 
handler, treating medical personnel, or a designated representative do 
not spell out the timeframe for which records can be produced based on 
 170.311(b)(6) (two year application information retention 
requirement). Each of subsections should include the phrase ``within 
the last two years'' to clarify that after two years there is no 
expectation that such records would have been retained.
    EPA should be clear on the differences between a ``designated 
representative'' and a person acting under the direction of medical 
personnel. Who are those ``persons''? While the two could be the same 
person, it is possible that in an emergency situation, the requirements 
for requesting the information as outlined may not be expedient.
    EPA Response. EPA has clarified in those sections that the 
information is accessible for only that period of time after it is 
collected and retained.
    USDA has also expressed concern that it is not clear who may access 
the information as a person acting under the direction of treating 
medical personnel. In consultation with USDA, EPA has revised the 
language to clarify that treating medical personnel and persons working 
under their supervision are to be given access to the information.
    c. USDA. Allowing oral requests to the employer by workers and 
handlers for pesticide application information and safety data sheets 
is not consistent with the EPA's new posting requirements that prohibit 
oral notification to workers of pesticide applications due to 
difficulty in recalling oral information, difficulty communicating 
orally if language barriers exist and the lack of verification of an 
oral notification. For these same reasons, oral notification to 
employers should be replaced with written notification. USDA encourages 
EPA to meet with stakeholders representing employers and farmworkers to 
best balance the oral versus written requests and the mechanism for 
collecting the written statement to designate the representative.
    EPA Response. USDA finds inconsistency between (1) the option for 
workers and handlers to orally request hazard information from their 
employer and (2) the requirement for the employer to post areas treated 
with a pesticide with an REI of greater than 48 hours. EPA does not 
agree that these requirements need to be consistent with each other. 
While it would be more convenient for employers to get a written 
request for the hazard communication information, in the interest of 
promoting access to workers and handlers who may not be literate and 
could not provide a written request, allowing oral requests facilitates 
the flow of information and outweighs the convenience for the employer. 
Posting a treated area under an REI as a visual warning is intended to 
provide an ongoing reminder to workers not to enter the area, because 
they may forget the oral notification given, or there may be confusion 
about which field is treated.
    Regarding USDA's comment about the mechanism for collecting the 
written request to designate the representative, the written 
information can be hand delivered, mailed, provided to the employer as 
an attachment to an e-mail, or any other way seen as appropriate. Oral 
identification of the designated representative is not sufficient.

    12.  170.313

    USDA. This section creates responsibilities for commercial 
pesticide handler employers (CPHEs) toward ``each handler'' or ``any 
handler,'' without limiting the CPHE's responsibility to only the 
handlers employed by the given CPHE. This may lead to difficulties and 
unintended consequences when multiple CPHEs are operating on the same 
agricultural establishment, or when an agricultural employer chooses to 
employ some handlers directly while contracting for additional handlers 
through a CPHE.
    Regarding subsection (b), how is a CPHE supposed to ensure that 
handlers employed by a different CPHE or handlers employed directly by 
the agricultural employer receive the protections required by the WPS?
    Regarding subsection (c), how is a CPHE supposed to ensure that 
handlers employed by a different CPHE or handlers employed directly by 
the agricultural employer are at least 18 years old?
    The same line of questioning also applies to subsections (d), (e), 
(f), (g), (h), and (k). A CPHE will not likely be able to follow these 
requirements with regards to handlers that are not employed by him or 
her and thus are not within his or her supervisory control. USDA 
recommends clarifying that for purposes of  170.313, the term 
``handler'' is limited to handlers employed by the CPHE (i.e., the 
CPHE's ``own'' handlers).
    In addition, if EPA makes the changes to the definition of ``labor 
contractor'' in  170.305 suggested above, EPA should remove references 
to labor contractors in this section. This is because any contractor 
who employs handlers will no longer be both a ``labor contractor'' and 
a CPHE, but only a CPHE instead.
    EPA Response. EPA does not believe that a CPHE has responsibilities 
for handlers other than its own handler employees because the required 
employer-employee relationship that triggers WPS responsibilities does 
not exist for handlers that are not employed by the CPHE. However, in 
the interest of providing greater clarity in the, EPA has clarified in 
the rule in 170.313 that the commercial pesticide handler employer 
duties are only applicable for handlers they directly employ. The 
revised reg text is included below:
   170.313  Commercial pesticide handler employer duties.
          ``Commercial pesticide handler employers must:

                  (a) Ensure that any pesticide is used in a manner 
                consistent with the pesticide product labeling, 
                including the requirements of this part, when applied 
                on an agricultural establishment by a handler employed 
                by the commercial pesticide handling establishment.
                  (b) Ensure each handler employed by the commercial 
                pesticide handling establishment and subject to this 
                part receives the protections required by this part.
                  (c) Ensure that any handler employed by the 
                commercial pesticide handling establishment is at least 
                18 years old.
                  (d) Provide to each person, including labor 
                contractors, who supervises any handlers employed by 
                the commercial pesticide handling establishment, 
                information and directions sufficient to ensure that 
                each handler receives the protections required by this 
                part. Such information and directions must specify the 
                tasks for which the supervisor is responsible in order 
                to comply with the provisions of this part.
                  (e) Require each person, including labor contractors, 
                who supervises any handlers employed by the commercial 
                pesticide handling establishment, to provide sufficient 
                information and directions to each handler to ensure 
                that the handler can comply with the provisions of this 
                part.
                  (f) Ensure that before any handler employed by the 
                commercial pesticide handling establishment uses any 
                equipment for mixing, loading, transferring, or 
                applying pesticides, the handler is instructed in the 
                safe operation of such equipment.
                  (g) Ensure that, before each day of use, equipment 
                used by their employees for mixing, loading, 
                transferring, or applying pesticides is inspected for 
                leaks, obstructions, and worn or damaged parts, and any 
                damaged equipment is repaired or is replaced.
                  (h) Ensure that whenever a handler who is employed by 
                the commercial pesticide handling establishment will be 
                on an agricultural establishment, the handler is 
                provided information about, or is aware of, the 
                specific location and description of any treated areas 
                where a restricted-entry interval is in effect, and the 
                restrictions on entering those areas.
                  (i) Provide the agricultural employer all of the 
                following information before the application of any 
                pesticide on an agricultural establishment:

                          (1) Specific location(s) and description of 
                        the area(s) to be treated.
                          (2) The date(s) and start and estimated end 
                        times of application.
                          (3) Product name, EPA registration number, 
                        and active ingredient(s).
                          (4) The labeling-specified restricted-entry 
                        interval applicable for the application.
                          (5) Whether posting, oral notification or 
                        both are required under  170.409.
                          (6) Any restrictions or use directions on the 
                        pesticide product labeling that must be 
                        followed for protection of workers, handlers, 
                        or other persons during or after application.

                  (j) If there are any changes to the information 
                provided in  170.313(i)(1),  170.313(i)(4),  
                170.313(i)(5),  170.313(i)(6) or if the start time for 
                the application will be earlier than originally 
                forecasted or scheduled, ensure that the agricultural 
                employer is provided updated information prior to the 
                application. If there are any changes to any other 
                information provided pursuant to  170.313(i), the 
                commercial pesticide handler employer must provide 
                updated information to the agricultural employer within 
                two hours after completing the application. Changes to 
                the estimated application end time of less than one 
                hour need not be reported to the agricultural employer.
                  (k) Provide emergency assistance in accordance with 
                this paragraph. If there is reason to believe that a 
                handler has experienced a potential pesticide exposure 
                during his or her employment by the commercial 
                pesticide handling establishment or shows symptoms 
                similar to those associated with acute exposure to 
                pesticides during or within 72 hours after his or her 
                employment by the commercial pesticide handling 
                establishment, and needs emergency medical treatment, 
                the commercial pesticide handler employer must do all 
                of the following promptly after learning of the 
                possible poisoning or injury:

                          (1) Make available to that person 
                        transportation from the commercial pesticide 
                        handling establishment, or any agricultural 
                        establishment on which that handler may be 
                        working on behalf of the commercial pesticide 
                        handling establishment, to an operating medical 
                        care facility capable of providing emergency 
                        medical treatment to a person exposed to 
                        pesticides.
                          (2) Provide all of the following information 
                        to the treating medical personnel:

                                  (i) Copies of the applicable safety 
                                data sheet(s) and the product name(s), 
                                EPA registration number(s) and active 
                                ingredient(s) for each pesticide 
                                product to which the person may have 
                                been exposed.
                                   (ii) The circumstances of 
                                application or use of the pesticide.
                                  (iii) The circumstances that could 
                                have resulted in exposure to the 
                                pesticide.

                  (l) Ensure that persons directly employed by the 
                commercial pesticide handling establishment do not 
                clean, repair, or adjust pesticide application 
                equipment, unless trained as a handler under  170.501. 
                Before allowing any person not directly employed by the 
                commercial pesticide handling establishment to clean, 
                repair, or adjust equipment that has been used to mix, 
                load, transfer, or apply pesticides, the commercial 
                pesticide handler employer must provide all of the 
                following information to such persons:

                          (1) Notice that the pesticide application 
                        equipment may be contaminated with pesticides.
                          (2) The potentially harmful effects of 
                        exposure to pesticides.
                          (3) Procedures for handling pesticide 
                        application equipment and for limiting exposure 
                        to pesticide residues.
                          (4) Personal hygiene practices and 
                        decontamination procedures for preventing 
                        pesticide exposures and removing pesticide 
                        residues.

                  (m) Provide any records or other information required 
                by this part for inspection and copying upon request by 
                an employee of EPA or any duly authorized 
                representative of a Federal, State or Tribal government 
                agency responsible for pesticide enforcement.''

    Please note that EPA has not removed the references to labor 
contractors in this section. This is because the rule must still 
address the possibility that a CPHE could hire handler labor through a 
labor contractor and the CPHE must be responsible for providing handler 
protections to individuals hired through a contractor. The final rule 
has been revised so that a CPHE is no longer considered a labor 
contractor under the WPS, and therefore the CPHE handlers will not be 
considered employees of the agricultural establishment when hired 
through the CPHE, but it recognizes that a CPHE may use labor 
contractors.

    13.  170.315  Whistleblower

    General comment: Because agricultural employers must already comply 
with OSHA regulations on health and safety, USDA seeks a broad inter-
agency discussion on whistleblower rights of workers. OSHA already 
investigates whistleblower complaints under seven environmental 
statutes, and established procedures are already in place for OSHA 
investigations. Is there a way to take advantage of existing OSHA 
investigative standards, regulatory processes and whistleblower 
investigative procedures for farm accidents, labor, chemical hazards, 
dust, wages, migrant housing, sanitation, drinking water, etc.? This 
would also take advantage of existing state whistleblower laws and 
regulations. Both growers and workers would benefit as there will be 
one Federal body to place whistleblower complaints and an existing 
regulatory process and infrastructure. One can therefore expect 
farmworkers, agricultural employers and labor contractors to experience 
reduced regulatory confusion.
    EPA Response. EPA is interested in meeting with OSHA regarding 
their whistleblower procedures and standards. The final WPS has adopted 
language consistent with OSHA's approach to providing whistleblower 
protections, and it makes sense to have similar processes for 
investigations. However, as it is not clear that OSHA can adequately 
enforce the WPS whistleblower provisions, EPA is not prepared to cede 
that responsibility to OSHA. Although OSHA jurisdiction covers most 
areas of agriculture, they do not cover pesticide use or establishments 
with fewer than 11 workers, i.e., the majority of the farms subject to 
the WPS.

    14.  170.401(a) and  170.501(a)  Annual Training

    USDA. After reviewing the public comments and conferring with state 
Departments of Agriculture, USDA finds that annual training for workers 
and handlers will place an excessive burden on states and growers, 
without any evidence of increased protections for workers. USDA 
recommends that training should be required at most every two years.
    Moreover, USDA urges that EPA confer with their state regulatory 
partners regarding the feasibility of annual training with respect to 
the ability of state and extension service personnel at local 
universities to enforce or provide training on an annual basis. USDA 
has noted letters of concern dated August 15, 2014, in the docket from 
the Association of American Pest Control Officials (AAPCO) and the 
National Association of State Departments of Agriculture (NASDA). 
Federalism and resource issues were raised by NASDA. Also, per the 
Louisiana AgCenter August 18, 2014, Docket Letter to EPA, ``In 
Louisiana, we already retrain workers and handlers every three years. 
This is a dramatic change requiring annual training rather than every 
five years. This would increase the cost of the program and limit 
opportunities to attend training sessions. What is the funding source 
to support this increase in the frequency of training events?''
    Finally, the Forest Service's experience with mandatory annual 
training is that such training becomes robotic and less useful over 
time. USDA is concerned that an annual training requirement will add 
costs without any appreciable benefit or increase in safety. Annual 
training for handlers is required in California, but probably not too 
many other places.
    EPA Response. EPA is sensitive to the concerns of agricultural 
employers regarding the potential burden of annual training. Many 
comments linked the concern for burden with EPA's proposal to eliminate 
one segment of trainers, certified applicators, from qualifying as 
trainers of workers. Based on the comments in support of allowing 
certified applicators to train workers, EPA reassessed the ability of 
certified applicators to provide worker training and has retained 
certified applicators as trainers in the final rule. EPA believes that, 
with the addition of certified applicators as trainers, there are 
adequate resources to provide worker safety training. Please refer to 
the USDA comment 18 from this document:

          ``USDA is very supportive of expanding the class of persons 
        qualified to train workers and handlers compared to the 
        proposed rule, and is especially in favor of allowing certified 
        applicators to train workers (170.401) and handlers (170.501). 
        This is particularly important to provide adequate numbers of 
        trainers without severely straining cooperative extension 
        trainer resources required to meet the annual training 
        requirement in the draft final rule. USDA also supports that 
        EPA retained the ability to use as trainers those who are so 
        identified at the state level as qualified trainers. That 
        allows the Forest Service in California to utilize registered 
        professional foresters as trainers; something that was fought 
        for in the past in state regulations.''

    Safety training is well recognized as an important factor to reduce 
workplace incidents. Despite the absence of studies on this subject, it 
is reasonable to attribute to the 1992 WPS the significant reduction in 
agricultural pesticide exposure incidents dating from the 
implementation of rule. Although EPA cannot attribute the reduction in 
incidents to particular provisions in the WPS, we think the rule has 
contributed significantly to this reduction, and EPA expects the number 
of incidents to be further reduced upon implementation of the 
amendments contained in this rule.

    15.  170.401(c)(1) [comment cross-referenced from EA]

    USDA. Due to the added training topics and other requirements, USDA 
does not believe that the estimated 45 minutes of training include 
ample time to thoroughly cover added topics and take questions. To 
allow for at least 5 minutes per training topic (11 for workers and 13 
for handlers) and at least 15 minutes for questions the estimated 
training time should be adjusted to 1.5 hours. This is still a 
conservative estimate and does not take into account the added time 
required when a translator is used.
    EPA Response. Many of the topics listed for training content are 
self-explanatory and do not require substantial elaboration. Current 
EPA training videos take about 30 minutes per session, including 
questions. While questions and answers from workers can be 
unpredictable in quantity and length, based on past experience EPA 
estimates that the training with added content will not take longer (on 
average) than 45 minutes.
    EPA recognizes there are many different languages in the workforce. 
The EA considers only new burdens that would result from the amendments 
to the existing WPS. Sections 170.130(c) and 170.230(c) of the existing 
WPS include the same requirement that training be conducted ``in a 
manner workers can understand.''

    16.  170.401(c)(3)

    USDA. EPA states that after the effective date, ``training programs 
required under this section must include, at a minimum, all of the 
topics listed in  170.401(c)(i)-(xvi) . . .'' This is followed by a 
list of 23 points numbered from (i) to (xxiii). If only the first 16, 
up to (xvi), should be included in future training, there is no reason 
to include the remaining 7 points in the rule. Alternatively, if all 23 
points should be included in future training, then the language should 
be corrected to include ``all of the topics listed in  170.401(c)(i)-
(xxiii) . . .''
    Most of the points listed in  170.401(c)(3), including (ii)-(xv) 
and (xix)-(xxii), sound like topics for training, as they should. 
However, there are a few points, notably (i), (xvi)-(xviii), and 
(xxiii), that sound like restated or new requirements placed on 
agricultural employers. Unlike the other points, these five points 
include ``agricultural employer'' as the subject together with 
commanding verbs such as ``are required,'' ``must not,'' ``must,'' and 
``are prohibited.'' This could easily lead to confusion if these points 
are misinterpreted as binding requirements, rather than training 
topics.
    In addition to being generally misleading, two of these five points 
include statements that are incorrect. First, (i) states that 
agricultural employers are required to ``provide pesticide safety 
training,'' (emphasis added) when in fact agricultural employers are 
merely required to ``ensure that each worker has been trained'' ( 
170.401(a), emphasis added), meaning that workers can be trained by a 
third party. Second, (xvi) states that agricultural employers are 
required to ``provide workers information about the location of safety 
data sheets,'' when in fact agricultural employers must display the 
safety data sheets ``at a place on the agricultural establishment where 
workers and handlers are likely to pass by or congregate'' and must 
allow workers ``access to the location of the information'' ( 
170.311(b)), but there is no express requirement to provide workers 
information about this location.
    USDA recommends that at a minimum, the language in (i) and (xvi) be 
corrected to properly reflect the requirements placed on agricultural 
employers in the WPS. EPA should also consider rewording all of the 
five points in question--(i), (xvi)-(xviii), and (xxiii)--to make it 
clear that these are merely topics for training, and not new 
requirements.
    EPA Response. EPA appreciates the correction, and has included all 
the points in the citation at 170.401(c)(3). EPA will revise the 
language at  170.401(c)(3)(i), (xvi)-(xviii), and (xxiii) to clarify 
their intent as training points.
    Regarding  170.401(c)(3)(i), USDA's comment is correct; the 
employer is required only to ensure that the worker or handler has been 
trained. Therefore, EPA has adjusted the language to reflect that 
distinction. However, the comment stating that there is not a 
requirement for employers to inform workers and handlers of the 
location of the safety data sheets that reflects the training point at 
170.401(c)(3)(xvi) is incorrect; please refer to 170.403(a) and 
170.503(b)(1) that instruct the employer to inform their employees of 
the location(s) of the safety data sheets.

    17.  170.401(c)(3)(i)

    USDA. Add the phrase ``in writing'' after ``designate'' to make it 
clear to workers that such designation must be in writing.
    EPA Response. This change has been made. The rule text at  
170.401(c)(3)(i) has been revised as follows:

          (i) Agricultural employers are required to provide workers 
        with information and protections designed to reduce work-
        related pesticide exposures and illnesses . . . A worker may 
        designate in writing a representative to request access to 
        pesticide application and hazard information.

    18.  170.401(c)(4) and  170.501(c)(4)  certified applicators

    USDA. USDA is very supportive of expanding the class of persons 
qualified to train workers and handlers compared to the proposed rule, 
and is especially in favor of allowing certified applicators to train 
workers (170.401) and handlers (170.501). This is particularly 
important to provide adequate numbers of trainers without severely 
straining cooperative extension trainer resources required to meet the 
annual training requirement in the draft final rule. USDA also supports 
that EPA retained the ability to use as trainers those who are so 
identified at the state level as qualified trainers. That allows the 
Forest Service in California to utilize registered professional 
foresters as trainers; something that was fought for in the past in 
state regulations.
    EPA Response. None required.

    19.  170.401(d)  National Data Base for trained workers and 
handlers

    USDA. USDA reminds EPA of the comments submitted by key stakeholder 
groups that have responsibilities for record-keeping:

    a. Association of American Pest [sic] Control Officials (AAPCO)

    AAPCO supports record-keeping of employee training. We recommend 
that the date of birth be removed as a requirement from the record, as 
this will complicate use of the record, since the birth date can be 
considered confidential information. The employer must verify age by 
other means (license, immigration documentation, etc.) for personnel 
purposes that are maintained separately. We recommend that the Agency 
provide a template for record-keeping that can be provided as a 
convenience for employers, but not make use of the template a 
requirement. The records should be kept by the agricultural employer.
    EPA Response. EPA was convinced by concerns raised by states 
regarding the confidentiality issues with personally identifiable 
information, and has removed the requirement for a record of the 
birthdate in the training record.
    EPA plans to develop an optional form that employers may use to 
collect training records.
    USDA.

    b. Association of American Pest [sic] Control Officials (AAPCO)

    AAPCO has serious concerns about the requirement in  
170.101(d)(2). The possibility for use of fraudulent records is real, 
and verification of the training record could require significant 
resources by state lead agency personnel, or may be impossible if the 
record is provided by an out of state trainer. AAPCO recommends that 
EPA develop a national data base that can be used by certified trainers 
to enter information, coupled with a national card with a scannable bar 
code. State lead agencies can access the data base to verify the 
training record. State lead agencies should not be expected to rely on 
the employee-provided record to verify training.

    National Association of State Departments of Agriculture (NASDA)

    We encourage EPA to consult with NASDA, SFIREG, AAPCO, and the 
regulated community to discuss and review the benefits and drawbacks of 
developing a central repository for basic training information 
submitted to and retained by EPA.
    EPA Response. Please refer to the notice of proposed rulemaking 
Unit VII B, 79 FR 15444, page 15463, for a discussion of the advantages 
and disadvantages of a centralized database for training records. EPA 
declined to propose requirements that would centralize the recorded 
information because it would burden employers to enter the data, and 
the requirement for on-site records for inspection purposes would 
remain. EPA continues to believe that the costs of such a scheme would 
outweigh its expected benefits. Although there are potential uses for a 
centralized database of trained workers and handlers, EPA believes that 
it would require significant resources committed to ensure data 
quality. Giving workers and handlers a copy of their training records 
on their request should provide workers and handlers a simple way to 
demonstrate prior training to a new employer.

    20.  170.405(a)

    USDA. USDA is concerned how helicopter or fixed wing applications 
can possibly meet this standard without de facto buffers. A pilot would 
otherwise have to be constantly scanning a distance of 100 from the 
aircraft in all directions looking for some errant person; which is a 
huge safety issue in itself. This essentially means that a 100 buffer 
remains with aerial applications.
    EPA Response. The provision in  170.405(a) establishes a 
requirement on the agricultural employer, not the applicator (handler). 
Specifically, an agricultural employer must not allow or direct a 
worker or other person to remain in the treated area or application 
exclusion zone within the boundaries of the establishment until 
application is complete. This is a relatively small extension of the 
current requirement in  170.110(a) for agricultural employers to keep 
workers and others out of a treated area during application on farms 
and forests. The final rule will cover a slightly larger area from 
which the agricultural employer must exclude workers and other persons 
but only while the application equipment is treating that specific 
section of the treated area. For the example of an aerial application, 
there would be an additional 100 area along the side of the treated 
area from which people must be excluded, but only while the helicopter 
or airplane is treating that edge of the field. Once the aircraft has 
left the edge of the field, workers and other persons must be excluded 
of only the treated area, as is currently required.
    As explained in Unit IX.B.2, EPA notes that the application 
exclusion zone is not a ``buffer,'' a term that typically is used to 
describe an area that cannot be sprayed. The application exclusion zone 
is simply an area around active application equipment that moves with 
the application equipment as the application progresses. Under the 
final rule, a pesticide can be applied in an application exclusion 
zone, and the requirement for agricultural employers is to keep workers 
and other people out of this zone (which is a specified distance from 
the application equipment, not the edge of the treated area) during the 
pesticide application.
    For additional information, see the response to question 26.

    21.  170.409(b)(3)(ii)--forestry signs

    USDA. The requirement to post outdoor production areas at all 
normal access points, or roads, or trails, or if no access points, at 
corners of the units can be problematic in forestry. Is a skid trail or 
a landing considered a road or access point? What if no roads or trails 
access the unit? Posting the corners makes no sense in such a case, as 
those would be essentially invisible anyway. EPA may want to reconsider 
posting requirements related to forestry regulations.
    EPA Response. The requirement in the final rule is that ``the signs 
must be visible from all reasonably expected points of worker entry to 
the treated area, including at least each access road, each border with 
any worker housing area within 100 of the treated area and each 
footpath and other walking route that enters the treated area.'' EPA 
does not believe the application of this proposal to forestry 
operations is unique or substantially from its application to large 
fields or orchards that may not have definitive points of entry. In the 
situation described above, the draft final rule would require the 
employer to consider whether the ``skid trail'' or landing is a 
reasonably expected point of worker entry; if so, then it must be 
posted. Where there are no reasonably expected points of worker entry, 
the draft final rule provides that ``signs must be posted in the 
corners of the treated area or in any other location affording maximum 
visibility.'' If as USDA suggests, the geography of a particular 
treated area makes posting the corners irrelevant, then the employer 
should post the locations providing maximum visibility for workers 
entering the treated area.
    EPA intends that the final rule should apply to these situations in 
the same manner as described in the existing WPS IGW guidance that 
addresses this topic (a copy of the WPS IGW guidance applicable to this 
issue is included below). It is worth noting that EPA intends to 
revisit all the existing WPS IGW guidance Q&As and will retain those 
that are still applicable, and will revise any guidance that is still 
necessary but needs to be updated to reflect changes in the final rule. 
EPA would be glad to work with USDA to revise the existing WPS IGW 
guidance related to posting such types of fields/forests to make sure 
it adequately addresses forestry concerns.
  13-10  Posting areas with unlimited entry points
          Question: If a treated area has unlimited entry points, how 
        often should treated-area warning signs be posted to be 
        ``visible from all usual points of entry?'' Every 100?
          Answer: The rule requires that signs be visible at all usual 
        points of worker entry, including at least each access road, 
        each border with any labor camp adjacent to the treated area, 
        and each footpath and other walking route that enters the 
        treated area. If there are many usual points of entry, then 
        signs must be visible from all usual points of entry. When 
        there are no usual points of worker entry, signs must be posted 
        in the corners of the treated area or a location affording 
        maximum visibility. In areas where there are unlimited points 
        of entry, the agricultural employer must determine the usual 
        points of entry and make signs visible from those points of 
        entry. (March 7, 1995)

    22.  170.411(b)  Decon water--1 gallon/worker

    USDA. Requiring a gallon of water at the beginning of the work 
shift for every worker entering a treated unit for a period lasting 30 
days after the REI could be problematic in forestry applications. If 
the water is always located in the worker's vehicle, it is probably not 
a major issue, although carrying extra canteens in the vehicle will be 
a change in procedures.
    EPA Response. Since the WPS requirement for the quantity of 
decontamination water for workers in the final rule is merely a 
codification of an existing WPS IGW policy that clarified what a 
``sufficient'' amount of water per worker was, EPA does not believe 
this change should represent a significant burden compared to the 
existing rule. Since this is water that only has to be available at the 
area where decontamination supplies are provided, or at the nearest 
point of vehicular access, the provision will not result in workers 
having to carry any water on their persons. It will only necessitate 
that the required amount of water per worker be available at the area 
where decontamination supplies are provided, or at the nearest point of 
vehicular access. Additionally, EPA believes the current exceptions in 
the rule for the location of decontamination supplies provide adequate 
flexibility to agriculture and forestry to accommodate the range of 
situations.

    23.  170.411(d) and  170.509(c)--define nearest place of 
vehicular access

    USDA. The term ``nearest place of vehicular access,'' which is 
where decontamination supplies must be stored when workers or handlers 
are working in remote areas, is not defined in the WPS. This location 
depends on whether one considers just regular automobiles that travel 
on paved or well-maintained unpaved roads; or also tractors and all-
terrain vehicles that can travel where regular automobiles cannot; or 
even helicopters, drones, and other aircraft. Is there a general 
standard for what ``nearest place of vehicular access'' means, or does 
it depend on which vehicles the agricultural employer or handler 
employer happens to have available at the time? USDA recommends the EPA 
include a definition of ``nearest place of vehicular access'' in  
170.305.
    EPA Response. EPA does not believe it is necessary to define the 
phrase ``nearest place of vehicular access'' because the term is 
sufficiently clear in its meaning without further explanation. USDA is 
correct that the nearest place of vehicular access would be dependent 
on the type of vehicle in use for the situation, and because it is not 
practical to describe all situations, EPA believes it is appropriate to 
use a general term that can be easily interpreted. In the 20 years of 
WPS implementation and taking questions from regulators and the 
regulated community, EPA is not aware of any serious disagreement 
related to the meaning of the phrase ``nearest place of vehicular 
access'', and feels that trying to define the term may reduce the 
existing flexibility in the rule afforded by the current approach.

    24. Subpart F,  170.501-170.509  Conflict between ``handler 
employer'' and ``CPHE employer''

    USDA. Subpart F assigns a host of responsibilities regarding 
handlers to the ``handler employer.'' As noted in the comments on  
170.305, the definition of ``handler employer'' is currently so broad, 
that at any given moment there could be two or more ``handler 
employers'' responsible for the same handler (i.e., the agricultural 
employer and one or more commercial pesticide handler employers).
    This dual responsibility is very problematic. Is each requirement 
in Subpart F supposed to be carried out in duplicate? This would mean 
that both the agricultural employer and the commercial pesticide 
handler employer would have to independently check the handler's 
training status (and keep the corresponding records), age, and 
knowledge of relevant information; both would have to ensure that 
handlers using highly toxic pesticides or fumigants within enclosed 
spaces are monitored regularly; and both would have to provide PPE and 
decontamination supplies to the handler. This approach would be 
ridiculously wasteful. At the same time, it is questionable whether 
splitting responsibility between the agricultural employer and the 
commercial pesticide handler employer would lead to better results, 
since the two parties would have to coordinate extensively to determine 
who will cover each requirement.
    USDA recommends that EPA address this problem by making the changes 
to the definition of ``labor contractor'' in  170.305 suggested above, 
which would have the practical effect of changing the definition of 
``handler employer'' to mean only the handler's direct employer, 
whether that is an agricultural employer or a commercial pesticide 
handler employer.
    EPA Response. EPA believes it has made the revisions to the rule 
text necessary to address USDA's concerns in this area. Please see 
EPA's responses to comments 8b and 12.

    25.  170.501(c)(3)(xiv)  training for handlers--error in reg text

    USDA. This section requires that the training for handlers include 
the following point: ``Handler employers must post treated areas as 
required by this rule.'' However, under  170.309(h) and  170.409, it 
is the agricultural employer--not the handler employer--who is required 
to display information and signs related to pesticide applications and 
worker entry restrictions. USDA recommends that EPA resolve this 
discrepancy.
    EPA [R]esponse. EPA corrected the text of the final rule to refer 
to the agricultural employer.

    26.  170.505(b)--AEZ--handler suspend application if person in 
zone, even when outside the property

    USDA. This section requires that handlers suspend pesticide 
application when individuals are present in the application exclusion 
zone. Unlike in  170.405(a)(2), there is no exception if the 
individuals are outside the boundaries of the agricultural 
establishment, for example on a neighboring property or on a public 
right-of-way. USDA recommends that the language in  170.505(b) should 
be adjusted to match  170.405(a)(2): ``. . . the handler performing 
the application must immediately suspend a pesticide application if any 
worker or other person [other than another handler] is in the 
application exclusion zone described in  170.405(a)(1) that is within 
the boundaries of the establishment . . .'' The agricultural employer 
has no control over individuals outside of the agricultural 
establishment, and this should be recognized by not requiring automatic 
suspension of application in situations where individuals beyond the 
boundaries of the establishment might peripherally encroach on an 
application exclusion zone. It should be noted that  170.505(a) 
already requires the handler to ``ensure that no pesticide is applied 
so as to contact, directly or through drift, any worker or other person 
[other than another handler].'' This renders superfluous the additional 
restriction in  170.505(b) requiring suspension when the application 
exclusion zone is encroached outside the establishment.
    EPA Response. EPA disagrees that the application exclusion zone 
should be limited to the boundaries of the agricultural establishment 
for the requirement in  170.505(b) for a handler to suspend 
application if a worker or other person is in the application exclusion 
zone.
    EPA agrees with USDA that labels and  170.210(a) already require 
handlers to apply in a way so pesticides do not contact a worker or 
another person. However, these provisions appear inadequate because 
drift from pesticide applications continues to cause human exposure 
incidents. EPA also agrees that an agricultural employer has no control 
over individuals outside the establishment, which is why the 
requirement for agricultural employers in  170.405(a) is limited to 
the boundaries of the agricultural establishment. However, the handler 
who is applying the pesticide does have the ability to temporarily 
suspend an application and restart it after the worker or person leaves 
the area. Handlers who are applying should already be doing this so 
they do not contact a worker or other person during application. As 
stated by the National Agricultural Aviation Association in their 
comments on the proposed rule, ``It is standard operating procedure for 
aerial applicators to temporarily avoid making passes adjacent to such 
[rural] roads if workers happen to be passing by in vehicles or on 
foot.''

    27.  170.507 [comment cross-referenced from EA] Respirator 
Requirement costs and update terminology

    USDA. The discussion of costs associated with respirator fit tests 
could be clarified by providing additional information on the types of 
pesticides that are assumed to require respirators, the frequency those 
pesticides are applied (every year or less frequently), and the number 
of farms likely to apply those pesticides.
    Consistent use of terminology: USDA commends the change of 
terminology from dust/mist filtering respirator to filtering facepiece 
respirator. Use of the OSHA terminology prevents confusion and 
contributes to more cohesive standards across agencies. USDA suggests 
the addition of this term to  170.205 to reflect the definition 
provided by OSHA in 29 CFR 1910.134 (b) (quoted below) for further 
clarity.

          ``Filtering facepiece respirator means a negative pressure 
        particulate respirator with a filter as an integral part of the 
        facepiece or with the entire facepiece composed of the 
        filtering medium.''

    EPA Response. EPA disagrees that a detailed discussion of the 
respirator cost analysis is needed in the Federal Register. Those 
details are included in the economic analysis.
    EPA appreciates USDA's comments on changing terminology from dust/
mist respirators to filtering facepiece respirators. The final WPS rule 
only uses the term filtering facepiece respirator in the preamble; it 
does not appear in the reg text itself. Therefore, EPA has added OSHA's 
definition of filtering facepiece respirator to Unit XV.A.3 of the 
preamble as follows: ``. . . Many farmworker advocacy organizations and 
some PPE manufacturers asserted that EPA should also apply the proposed 
standards for fit testing, training, and medical monitoring to users of 
filtering facepiece respirators in addition to the other respirator 
types (e.g., tight fitting elastomeric facepieces). Commenters 
suggested that filtering facepiece respirators are widely used and 
covered by OSHA's respirator requirements, and that their exclusion 
would result in inadequate protection for many pesticide handlers. OSHA 
defines a filtering facepiece as `a negative pressure particulate 
respirator with a filter as an integral part of the facepiece or with 
the entire facepiece composed of the filtering medium' in 29 CFR 
1910.134(b).''

    28.  170.509(b) and (d)  decon water in forestry

    a. USDA. Requiring 3 gallons of water per handler at the beginning 
of the work shift will be problematic, especially if added to the eye 
wash requirement of 6 gallons of water for mixer/loaders using 
pesticides requiring protective eyewear. When using backpack 
applicators, each handler is at some point a mixer/loader (loading from 
a batch tank into the backpack, most commonly). A crew of 8 applicators 
could then potentially need 72 gallons of water to be carried each day. 
This seems excessive. It is clear that each handler requires 3 gallons 
of water at the start of the shift for decontamination, but in such a 
circumstance as described, would a crew of 8 each need 6 gallons for 
eye flushing, or would one quantity of 6 gallons meet the requirement? 
This could be clarified.
    EPA Response. Section 170.509(d) requires an emergency eye wash 
system at the mixing/loading site immediately available to the handler 
when a handler is mixing or loading a product whose labeling requires 
protective eyewear for handlers. Only one emergency eye wash system 
(that meets the WPS requirements) is required at a mixing/loading site 
regardless of how many handlers are mixing or loading at that site. EPA 
has revised Unit XII.C.3 of the preamble as follows to clarify this: 
``. . . The final rule allows employers to provide either at least 6 
gallons of water in containers suitable for providing a gentle eye 
flush for about 15 minutes, or a system capable of delivering gently 
running water at a rate of 0.4 gallons per minute for at least 15 
minutes to satisfy the requirement. One emergency eye wash system is 
required at a mixing/loading site when a handler is mixing or loading a 
product whose labeling requires protective eyewear to handlers, 
regardless of how many handlers are mixing or loading at that site.'' 
The final rule retains the existing requirement for water to be of ``a 
quality and temperature that will not cause illness or injury.''
    b. USDA. May this water be drafted from local natural surface 
waters (woodland stream)? May the requirement be met by pre-positioning 
6 gallons at the nearest place of vehicular access outside any treated 
area or area subject to a restricted-entry interval? Clarification 
invited.
    EPA Response. The water in an emergency eye wash system can be 
drawn from local natural surface waters if the handler employer has 
determined the water meets the standard of being ``of a quality and 
temperature that will not cause illness or injury when it contacts the 
skin or eyes or if it is swallowed'' as required in  170.509(b)(1). An 
emergency eye wash system at the nearest place of vehicular access 
would not satisfy the requirement of  170.509(d)(1) unless it is ``at 
the mixing/loading site immediately available to the handler.''

    29.  170.601(a)(1)(xii)--mistake in numbering in reg text

    USDA. This point references  170.605(a) through (c) and (e) 
through (k). However, the rule as currently written does not include a 
 170.605(k), only (a) through (j). EPA likely meant to write  
170.605(a) through (c) and (e) through (j).
    EPA Response. This change has been made to the rule text.
USDA Comments on EPA Worker Protection Standard Economic Analysis
    30.  170.311  Display Requirements for Pesticide Application and 
Hazard Information

    a. USDA. The economic analysis does not account for provision of 
safety data sheet and information about the application to the worker 
or a designated representative within 15 days of request for such 
material. In addition, there is no cost assumed for mailing this 
material to the designated representative. There is no estimate of the 
expected number of requests for this information by workers or their 
representatives. These costs should be included.
    EPA Response. These costs have now been included in the EA (Section 
3.3.2) and Appendix B (Section 2, Tables B.2.a-2 and B.2.a-5). EPA 
calculates that the cost of responding to a request from a current 
employee to be about $3.50 and the cost of responding to a request from 
a former employee to be about $14, including mailing costs. It does not 
seem likely that costs would vary substantially whether the request 
comes directly from an employee or from a designated representative.
    The number of requests is subject to a great deal of uncertainty; 
however, California and Texas have similar provisions and have not 
suggested that the issue arises frequently. For purposes of the EA, EPA 
has assumed that current employees may request hazard information once 
for every 20 applications made while one in 100 former employees may 
make a request.
    b. USDA. The economic analysis assumes all farms have double-sided 
copies when it estimates 3.3 pages are required to store the Safety 
Data Sheet, reported to be 6.7 pages on average (Table B.2.b.1 Cost per 
Final Rule, WPS Farms, Information on Pesticide Applications, p. 17, 
Appendix B).
    EPA Response. That is correct.
    c. USDA. The period over which these records must be made available 
to the worker is unclear. The cost of retaining these records over time 
should be included and as well as the period over which they must be 
retained.
    EPA Response. Records must be retained for two years 
(170.311(b)(6)). Retention costs are the cost of the folder used to 
store the documents, and are included in the EA.

    31.  170.401  Training Requirements for Workers

    a. USDA. Due to the added training topics and other requirements, 
USDA does not believe that the estimated 45 minutes of training include 
ample time to thoroughly cover added topics and take questions. To 
allow for at least 5 minutes per training topic (11 for workers and 13 
for handlers) and at least 15 minutes for questions the estimated 
training time should be adjusted to 1.5 hours. This is still a 
conservative estimate and does not take into account the added time 
required when a translator is used.
    EPA Response. EPA's experience with the training material, as well 
as information provided in comments, suggest that current training 
sessions are about 30 minutes in length. One respondent to a 
questionnaire by the National Council of Agricultural Employers 
indicated that in the past year they spent about 2,100 hours training 
4,400 workers, or slightly less than 30 minutes per worker. See EPA's 
response to Comment 15, above.
    b. USDA. The Economic Analysis does not take into consideration the 
cost of a translator for training. Though a translator is not required 
by the regulation, it does suggest the use of a translator in order to 
ensure that training is carried out ``in a manner workers understand'' 
(citation). These costs could be incorporated by estimating a 
reasonable probability of the number of trainings that will require a 
translator. Since EPA plans to develop training materials in several 
languages, the probability of requiring a translator could be estimated 
based on which languages and dialects would not be covered by those 
materials.
    EPA Response. The EA considers only new burdens that would result 
from the amendments to the existing WPS. Sections 170.130(c) and 
170.230(c) of the existing WPS include the same requirement that 
training be conducted ``in a manner workers can understand''.
    c. USDA. Small farms bear a disproportionately larger cost for the 
new training requirements than large farms. The economic analysis 
Appendix B states that worker training costs will result in an increase 
of 85% over baseline costs for small-small WPS farms, and increase by 
75% for medium-small WPS farms and large-small WPS farms with less than 
10 employees, 48% for large-small farms with 10 or more employees, and 
42% for large WPS farms. It would be clearer if costs were summarized 
for each of these farm size categories for each of the rule provisions 
throughout the economic analysis.
    EPA Response. USDA appears to have misunderstood the information in 
Appendix B. The percentage changes reported do not refer to increases 
in overall costs, only the change in the number of trainings needed. 
For example, the Appendix states that ``Small-small farms (revenue/year 
less than $10,000) are assumed to hold an average of 1.2 training 
sessions per year, an increase of 85% over the baseline.'' That is, the 
number of training sessions increases from an average of 0.65 sessions 
to 1.2 sessions, an absolute increase of 0.55 sessions. EPA assumes a 
large farm (revenue %$750,000) with more than 10 workers will increase 
the average number of training sessions from 4.5 sessions to 6.4, an 
absolute increase of 1.9 sessions.
    EPA has provided a summary of costs by farm size throughout the 
analysis and provided an analysis of overall impacts to small farms, 
defined by the Small Business Administration as entities with revenue 
less than $750,000. Because this definition implies that 95% of all 
U.S. farms, and almost 80% of farms affected by the WPS, are small, EPA 
also provides a more detailed analysis to examine the impacts across 
the distribution of small farms.
    d. USDA. The cost per farm of training workers or handlers appears 
to assume that only 1 training record per training needs to be retained 
by the farm (Table B.1.b.3. Cost under Final Rule, cost per WPS farm by 
size, Worker Training). For both large and small WPS farms, the 
economic analysis assumes retention of only one copy per training 
event. If a worker requests a copy, USDA assumes that only the worker's 
information will be provided and not the records of other workers who 
also attended the training. If EPA assumes the employer will provide 
records for all workers attending training (for example on the same 
sign-in sheet) when one worker requests their training record, the 
impact of this provision on privacy requirements should be included in 
the analysis. If privacy constraints prevent sharing records of other 
workers, the cost of record retention at the farm level should reflect 
the cost of providing individual records.
    EPA Response. EPA's goal is to make the process of confirming 
training as easy as possible. The record of the training can be as 
simple as a paper with the following information:

  (i)  The trained worker's printed name and signature.

  (ii)  The date of the training.

  (iii)  Information identifying which EPA-approved training materials 
            were used.

  (iv)  The trainer's name and documentation showing that the trainer 
            met the requirements of  170.401(c)(4) at the time of 
            training.

  (v)  The agricultural employer's name.

    As the draft final rule does not require the collection of any 
personally identifiable information, no personally identifiable 
information would be included in the record. For a worker to confirm to 
a subsequent employer that he or she has recently completed the 
pesticide safety training, a copy of the training record would have the 
information needed for the subsequent employer's records.
    e. USDA. As part of their preliminary research, EPA conducted a 
Small Business Administration Review Panel (SBAR Panel or Panel). In 
almost every written comment they received, small business owners urged 
them to keep a grace period for employee training. Since EPA conducted 
a SBAR Panel, USDA would like to see an acknowledgment that these 
issues were taken into consideration. Though most of the commenters did 
not see many real cost added with removing (or decreasing) the grace 
period, they did indicate that workers would have to be hired sooner 
and thus paid for days where the employer received no work. If the time 
lost from work is considered in the benefits section regarding 
healthcare, then time lost from work due to training and paperwork must 
be considered in the costs.
    EPA Response. EPA thinks the elimination of the grace period is not 
likely to lead employers to hire workers and pay them for no work. 
Rather, EPA anticipates that employers may have to provide additional 
training sessions (see response 31.c.). The opportunity cost of time 
for the worker to attend a safety training is included in the estimated 
cost of the revisions.
    f. USDA. The elimination of the grace period and the requirement 
that all workers be trained ``in manner workers understand'' creates 
the potential for discrimination on the basis of language and literacy. 
Economic analysis should discuss the probability that workers who speak 
the language used by the employer or by on-site trainers will be used 
more frequently when training is required by temporary or seasonal 
workers immediately prior to performing a field or handler task. If a 
farm must train workers immediately before any allowable exposure to 
pesticides, the most easily trained workers will be more likely to be 
used in job situations where exposure could occur, at least initially.
    EPA Response: EPA notes that the requirement for training to be 
provided in a manner that the worker can understand is not new. EPA has 
not received comment regarding discriminatory practices related to 
language as a result of the WPS.

    32.  170.507  Personal Protective Equipment

    a. USDA. Consistent use of terminology: USDA commends the change of 
terminology from dust/mist filtering respirator to filtering facepiece 
respirator. Use of the OSHA terminology prevents confusion and 
contributes to more cohesive standards across agencies. USDA suggests 
the addition of this term to  170.205 to reflect the definition 
provided by OSHA in 29 CFR 1910.134 (b) (quoted below) for further 
clarity.

          ``Filtering facepiece respirator means a negative pressure 
        particulate respirator with a filter as an integral part of the 
        facepiece or with the entire facepiece composed of the 
        filtering medium.''

    Costs and benefits: In the cost estimate for the addition of 
filtering facepiece respirators the Agency assumes that all employers 
will use the suggested online medical evaluation (introduced in lines 
3388-3394 of the rule preamble) from the outset. While the use of 
online medical evaluations would be the most cost-effective option for 
employers, assuming that employers will be able to use this method of 
evaluation in the first years of implementation does not seem likely. 
This is especially true for rural areas where broadband access is not 
available on every farm operation. Though online medical evaluations 
will likely be used by some employers, the estimated probability seems 
high for the first year. The probability of using an off-site medical 
evaluation is much more likely in the first year with a decreasing 
probability within the first five years as employers learn more about 
their available options.
    EPA Response. EPA does not agree with USDA's reasoning. Employers 
are unlikely to forego cost-effective options, even initially. EPA 
plans significant outreach and is confident that private interests, 
including crop advisors and pesticide dealers, will engage in similar 
programs. According to the 2012 Census of Agriculture almost 70% of 
U.S. farms have Internet access and most have high-quality service, 
including broadband or DSL. Less than 10% of farms rely on dial-up 
connections.
    b. USDA. Additionally, the time estimate for an off-site medical 
evaluation (Table 3.3-34) should use the same estimate as the follow-up 
medical exam ($72.12). The analysis must also take into consideration 
the lost wages and travel time associated with visiting a medical 
professional considering that most farm operations are located in rural 
areas where access to a licensed medical professional may increase time 
and travel. The time should at least reflect the time allotted to the 
evaluation, but should also include at least 30 minutes of travel time. 
Please see table below for an example of suggested edits.

  Table 3.3-34. Costs under Final Rule, Large WPS Farm, Respirator Fit
                                  Test
------------------------------------------------------------------------
                                                 annual
    Action/                      unit time/     frequency
 Material (j)   wage/price wj     quantity     Prob (jDi)       cost
                               Hr,i,j/Mr,i,j
------------------------------------------------------------------------
    Time for       $20.04/hr       1.5 hour          0.535        $16.08
      medical
  evaluation
    Off-site          $72.17              1          0.535        $38.61
   evaluation
     On-line          $27.00              1          0.134         $3.62
   evaluation
    Time for       $20.04/hr         2 hour          0.134         $5.36
    follow-up
    exam \1\
   Follow-up          $72.17              1          0.134         $9.66
      medical
    exam \1\
Time for fit       $20.04/hr       1.5 hour          0.535        $16.09
        test,
   with travel
Fit test and          $50.00              1          0.535        $26.76
     training
    Employer       $33.44/hr         1 hour          0.535        $17.90
      manage-
        ment
Collect/Store      $33.44/hr          4 min          0.535         $1.19
        docu-
   mentation
                                                           -------------
  costr,i,aP                                                     $135.27
------------------------------------------------------------------------
Source: EPA estimation. See text for data sources. Numbers may not sum
  due to rounding. 1 EPA assumes approximately 25 percent of handlers
  taking the medical evaluation will be referred for a more complete
  medical examination.

    EPA Response. EPA does not agree with USDA's reasoning that 
employers will select a more costly response to the regulatory burden. 
Further, if they choose to skip the screening evaluation for a complete 
medical evaluation e.g., because of a previously scheduled physical 
examination, there would be no need for an on-line (screening) 
evaluation or subsequent follow-up evaluation.
    c. USDA. In the Economic Analysis for the rule, EPA explains that 
it derives costs for respirator fit tests from the assumption that each 
farm will only have one handler that will need to be fit tested and 
that only 40 percent of farms will likely use pesticides that require 
respirators.

          ``Accounting for the fact that not all farms will use 
        pesticides every year, EPA estimates about 40 percent of large 
        farms and large-small farms will use a product requiring a 
        respirator. A farm is unlikely to need more than one handler 
        when using these products, so for ease we calculate costs at 
        the farm level. Further, some handlers will undergo fit testing 
        because the requirement has been incorporated onto some product 
        labels, for example, various soil fumigants.'' (Economic 
        Analysis  3.3.6)

    With the addition of filtering facepiece respirators, USDA does not 
believe this estimate is accurate. First, though only one handler may 
be involved in pesticide use at a time, this does not imply that there 
is only one handler on the farm that will need to be fit tested. The 
number of handlers per farm that need fit tests should be estimated 
based on small versus large WPS farms.
    Second, the assumption that only 40 percent of farms will use 
pesticides that require respirators seems low considering the addition 
of filtering facepiece respirators (which are required for a much 
larger number of pesticides than chemical cartridge respirators (NIOSH 
23-C)). USDA urges EPA to gather further data on the number of 
pesticide labels that require respirators (including filtering 
facepiece respirators) and use that data to re-estimate the cost of 
respirator fit tests.
    EPA Response. EPA notes that USDA is quoting the baseline 
estimation of cost, where about 40% of the larger farms ultimately use 
a product requiring a respirator and the employer provides the handler 
with instruction on fit and use. Under the final rule, EPA assumes that 
over half of the larger farms will arrange for a handler to be tested.
    d. USDA. The discussion of costs associated with respirator fit 
tests could be clarified by providing additional information on the 
types of pesticides that are assumed to require respirators, the 
frequency those pesticides are applied (every year or less frequently), 
and the number of farms likely to apply those pesticides. The economic 
analysis could be strengthened by providing a more detailed explanation 
for the assumption that under the baseline and final rule, 60% of crop-
producing farms use pesticides requiring respirators with an annual use 
at 40% of these farms. In Appendix A, 76% of crop-producing WPS farms 
are estimated to use pesticides. It is unclear whether the 60% estimate 
requiring respirators includes pesticides requiring only the filtering 
facepiece respirators as well as pesticides requiring other types of 
respirators. The baseline calculation for the cost of fit tests at WPS 
farms assumes 40.4% of these farms will have a handler undergo a fit 
test with 3% of these baseline fit tests consistent with OSHA 
requirements. The final rule calculations assume 53.5% of large and 
13.4% of large-small WPS farms have handlers undergoing fit tests. EPA 
should present the baseline percentage of WPS farms where handlers 
undergo fit tests in terms of large and large-small WPS farms to allow 
direct comparison between the two scenarios.
    EPA Response. EPA does not think further discussion is warranted. 
As noted in the EA, ``Pesticides bearing label requirements for 
respirators are not common, but there are a few commonly used 
pesticides with the requirement.'' The requirement is product-specific 
and may apply to the mixer/loader and/or to the applicator. In the end, 
EPA assumes that 75% of large and large-small primarily crop farms 
(farms with annual revenue of $750,000 or more and farms with annual 
revenue between $100,000 and $750,000, respectively) will account for 
virtually all respirator use subject to the WPS. According to data from 
the 2012 Census of Agriculture, farms primarily producing crops (NAICS 
111) in these size ranges account for about 67% of all crop acreage in 
the U.S., but about 80% of all herbicide and insecticide treated 
acreage and over 90% of all acres treated with fungicides or plant 
growth regulators.
    e. USDA. The family farms fit test calculation needs further 
clarification. The economic analysis references Appendix A for the 
number of family farms by category (large, large-small, etc.). Appendix 
A does not discuss family farms explicitly--by back-calculating from 
the existing tables you could derive the number of family farms but 
this adds some uncertainty and the values do not match those reported 
in the economic analysis (18,949 large family farm and 141,753 large-
small family farms). Further explanation or support is needed for the 
assumption that 40% of family farms producing crops use a pesticide 
requiring a respirator.
    EPA Response. EPA acknowledges that Appendix A does not contain 
information on so-called family farms, i.e., those farms that do not 
report hired labor. However, EPA has provided the exact numbers used 
within the analysis.
    f. USDA. The values used in the baseline analysis for respirator 
fit tests at WPS farms are not consistent between the main economic 
analysis and its explanatory [A]ppendix B (See Table 3.3.32. Baseline 
Costs, per Large and Large-Small WPS Farm, Respirator Fit, Economic 
Analysis versus Table B-6.a.3. Baseline Cost, per WPS Farm, Respirator 
Fit, Appendix B). Likewise, the values reported in Appendix B for the 
number of large (79,434) and small-large (141,753) WPS farms do not 
appear in Appendix A where the reader is referred for further 
information. Since the population of WPS farms affected by the rule is 
assumed to only include crop-producing farms, it is assumed that these 
values represent crop-producing farms hiring labor (shown in Table 
A.1.10 of Appendix A). Further explanation would strengthen the 
economic analysis.
    EPA Response. EPA acknowledges that Appendix B was in error and 
revised the tables and explanations.
    g. USDA. In the cost estimate (p. 90, Economic Analysis) for the 
addition of filtering facepiece respirators the Agency assumes that all 
employers will use the suggested online medical evaluation (introduced 
in lines 3388-3394 of the rule preamble) from the outset. While the use 
of online medical evaluations would be the most cost-effective option 
for employers, assuming that employers will be able to use this method 
of evaluation in the first years of implementation does not seem 
likely. This is especially true for rural areas where broadband access 
is not available on every farm operation. Though online medical 
evaluations will likely be used by some employers, the estimated 
probability seems high for the first year. On-line medical evaluations 
are currently offered only in Spanish and English. Workers speaking 
other languages will need off-site medical evaluations. The probability 
of using an off-site medical evaluation is much more likely in the 
first year with a decreasing probability within the first five years as 
employers learn more about their available options.
    EPA Response. EPA does not agree with USDA's reasoning. Employers 
are unlikely to forego cost-effective options, even initially. EPA 
plans significant outreach and is confident that private interests, 
including crop advisors and pesticide dealers, will engage in similar 
programs. According to the 2012 Census of Agriculture almost 70% of 
U.S. farms have Internet access and most have high-quality service, 
including broadband or DSL. Less than 10% of farms rely on dial-up 
connections. EPA does not see language as a significant barrier for 
employers and handlers.
    h. USDA. The cost of the off-site medical evaluation used in the 
economic analysis is based on a single provider--Affordable Safety 
Training, offered in English and Spanish. A quick review of on-line 
medical evaluations for fit testing shows a range of products from the 
$25 for McHaney and Associates to $27 for Affordable Safety Training to 
$28 for a 3M on-line medical evaluation. These products are only 
offered in English and Spanish. If these medical evaluation materials 
need to be provided in other languages, there is no cost considered for 
this in the economic analysis. The Affordable Safety Training web site 
offers a fit test kit for $140 using Bitrex and $139.95 using 
saccharin. The economic analysis cites the cost for a fit test as 
ranging between $80 and $140 for an employer administered test.
    EPA Response. EPA agrees that there are multiple options of similar 
price. Fit test kits come in a range of prices with smoke tests 
typically costing less than other options. EPA does not see language as 
a significant barrier for employers and handlers.
    i. USDA. The economic analysis does not include costs accounting 
for circumstances requiring the same person to repeat the fit test for 
a different class of respirator which may involve additional 
measurements. The medical evaluation questionnaire required by OSHA 
lists two separate categories of respirators. A worker/handler would 
need an additional fit test and evaluation if required to use another 
class of respirator. The analysis also does not consider agricultural 
establishments where the same person is not the handler for all 
pesticides or for the entire year. Seasonal workers may not remain at 
an establishment for the entire period where pesticides requiring 
respirators may be applied.
    EPA Response. EPA does not think the cost of a medical screen would 
be significantly increased if the handler seeks testing for different 
classes of respirators. Multiple respirators could be tested at an off-
farm site or tested using the same test kit.

    33.  170.601  Exemptions--family farms

    a. USDA. Family farm exemption is too narrow: The exemption for 
family farms applies to any agricultural establishment that is wholly 
owned by an individual, or where all of the owners of the establishment 
are members of the same immediate family. This definition is narrower 
than the definition used by ERS in the Agricultural Resource Management 
Survey (ARMS). The ERS definition is more flexible and requires only 
that the majority of the business is owned by the operator and 
individuals related to the operator by blood, marriage, or adoption, 
including relatives that do not live in the operator's household. Using 
this definition, ERS finds around 97% of all farms are family farms 
based on data from ARMS.
    Findings from the 2013 ARMS survey indicate that 97.6 farm are 
family farms, using the ERS definition. Family farms are organized as 
individually owned, partnerships, corporations and other types of legal 
status (trust, estate, cooperative). The largest category of ownership 
in family farms is individual ownership (91.5%). Partnerships account 
for 4.4 %, corporations for 3.3 % and other types of legal status for 
0.8 %. Family farms that are not individually owned account for 173,434 
farms.
    It is unclear how many of the farms considered family farms in the 
economic analysis would meet the definition required in the 
agricultural establishment exemption. The EPA should estimate how many 
of the crop producing family farms would be not be eligible for the 
exemption and thus should be counted in population of farms that must 
comply with the WPS standard. If ownership type is distributed 
similarly between crop producing family farms and all family farms, as 
many as 8% of crop producing farms may not be eligible for the 
exemption.
    EPA Response. To determine the number of farms that would be 
impacted by revisions to the WPS, EPA considered all farms hiring labor 
as reported in the 2012 Census of Agriculture. Since farms may describe 
in their Census report as hired labor persons who would qualify for the 
WPS immediate family exemption, EPA has probably overestimated of the 
number of farms and workers/handlers affected by the WPS.
    b. USDA. The definition of immediate family is too narrow. In 
regard to establishing a minimum age for handlers and workers 
performing early-entry tasks, the final rule requires that handlers and 
workers performing early-entry tasks be at least 18 years old, rather 
than the proposed minimum age of 16 years old. This minimum age does 
not apply to an adolescent working on an establishment owned by an 
immediate family member. (EPA WPS FR page. 7). EPA has finalized the 
definition of ``immediate family'' as limited to the owner's spouse, 
parents, stepparents, foster parents, father-in-law, mother-in-law, 
children, stepchildren, foster children, sons-in-law, daughters-in-law, 
grandparents, grandchildren, brothers, sisters, brothers-in-law, and 
sisters-in-law (EPA WPS FR page 169).
    The EPA should reconsider the definition of immediate family. The 
proposed definition would not allow the exemption to youth who would 
work for a more distant family member such as an uncle. This definition 
would also not allow the exemption to youth whose parents are farm 
operators, but not owners. The Department of Labor (DOL) has exemptions 
for youth in the child labor requirements in agricultural occupations 
under the Fair Labor Standards Act. The Act states: ``A child of any 
age may be employed by his or her parent or person standing in place of 
the parent at any time in any occupation on a farm owned or operated by 
that parent or person standing in place of that parent'' (http://
www.dol.gov/whd/regs/compliance/childlabor102.pdf). EPA should revise 
their definition of immediate family, or the exemption itself to be 
more consistent with rules enforced by DOL.
    EPA Response. Under the owner and immediate family exemption in the 
existing WPS, establishments that qualify must be either wholly owned 
by the individual, or all owners of the establishment must be members 
of the same immediate family. While EPA is proposing to expand the 
types of familial relationships that would be considered ``immediate 
family'' under the WPS, EPA did not consider and does not plan to 
further expand the exemption to allow farms that are majority owned by 
family members to qualify. EPA did not propose such a change to the 
requirement and has not received comments from the public indicating 
that the current requirement for the establishment to be wholly owned 
by an individual or persons who are all members of the same immediate 
family is too restrictive.
                             [attachment 9]
August 18, 2014

  Hon. Gina McCarthy,
  Administrator,
U.S. Environmental Protection Agency,
Washington, D.C.

Re: Agricultural Worker Protection Standard Revisions; Docket ID #EPA-
            HQ-OPP-2011-0184

    Dear Administrator McCarthy:

    Migrant Clinicians Network (MCN) welcomes this important 
opportunity to comment on the proposed revisions to the Agricultural 
Worker Protection Standard (WPS). MCN is a national clinical 
organization with over 10,000 health care provider constituents 
dedicated to health justice for the mobile under-served, including 
migrant and immigrant farmworkers and their families. MCN states 
unequivocally that farmworker occupational safety and health is a 
critical health priority. Since our inception in 1984 we have worked to 
eliminate health disparities among farmworkers. In particular we have 
focused on occupational health disparities, as the work and lifestyle 
that accompanies this vulnerable population places migrants at higher 
risk for injuries and other health problems. We have worked to address 
pesticide exposure on a number of levels, including our national 
program to improve clinical practices regarding the recognition and 
management of pesticide poisonings, in partnership with the U.S. 
Environmental Protection Agency (EPA).

    We write to support many aspects of the proposed WPS that foster 
worker health and safety for an estimated 2 million workers across the 
United States who harvest our food. Additionally, we highlight areas of 
the proposed regulation that need to be strengthened to better protect 
farmworkers from pesticide exposure. These vulnerable workers, the 
majority of whom are immigrants from Mexico and other Latin American 
countries, have limited English proficiency, low educational 
attainment, and poverty-level incomes. They are also the most 
overexposed population to pesticides.

    Economic analysis of the proposed rule: In its economic analysis in 
support of the proposed rule, EPA acknowledges that many acute 
pesticide incidents are underreported and adjusts its calculation 
regarding costs and benefits to account for the unreported costs of 
acute pesticide incidents. (79 Fed. Reg. No. 53 at 15449). MCN supports 
EPA's acknowledgement of underreported pesticide incidents. MCN 
provides training to clinicians to recognize the signs and symptoms of 
pesticide exposures and underscores the importance of reporting 
pesticide poisonings to the appropriate state agencies. Once trained, 
clinicians have repeatedly acknowledged that they likely have 
misdiagnosed and/or failed to report pesticide exposures. In 2014, over 
\1/2\ the clinicians participating in MCN trainings stated they were 
unfamiliar with the pesticide reporting requirements in their state and 
did not know which agency to contact to report pesticide poisonings. 
MCN's Chief Medical Officer, Ed Zuroweste, M.D., has worked in the 
field of migrant health for over 30 years as a frontline physician, 
medical director of a migrant health center and a clinical consultant 
assessing health center performance. He has trained and provided 
technical assistance to thousands of clinicians. He states, ``I have 
yet to meet an experienced clinician who has not admitted that he or 
she misdiagnosed or failed to report a pesticide exposure.'' A survey 
of environmental medicine content in U.S. medical schools found that 75 
percent of schools require only about seven hours of study in 
environmental medicine over four years.\1\ Of the clinicians MCN 
trained in 2014, 45 percent had less than one hour of training in 
environmental and occupational health. It is not surprising that 
clinicians are unprepared to accurately recognize and manage (including 
report) pesticide exposure. Clinicians are also challenged in making an 
accurate diagnosis and reporting exposures as there are few readily 
accessible confirmatory clinical tests for pesticide poisoning.\2\ 
Clinicians undoubtedly resist reporting to public health agencies 
unless diagnosis is certain and reporting is mandated. Although 30 
states have rules requiring some form of clinician reporting of 
pesticide exposure and illness, only 12 states have a surveillance 
program to act on these reports.3-4 Underreporting is also 
due to many workers not seeking medical attention for overexposures as 
they do not understand their rights and fear losing their jobs.
---------------------------------------------------------------------------
    \1\ Schenk M., Popp S.M., Neale A.V., Demers R.Y. Environmental 
medicine content in medical school curricula. Acad. Med. 1996 May; 
71(5): 499-501.
    \2\ American Public Health Association. APHA Policy Statement 
20108: Requiring Clinical Diagnostic Tools and Biomonitoring of 
Exposures to Pesticides. Washington, D.C.: American Public Health 
Association. 2010. Available at: http://www.apha.org/advocacy/policy/
policysearch/default.htm?id=1400. Accessed August 4, 2014.
    \3\ National Institute for Occupational Health and Safety. 
Pesticide-related illness and injury surveillance: a how-to guide for 
state-based programs. DHHS (NIOSH) Publication Number 2006-102. 
Washington, D.C.: National Institute for Occupational Health and 
Safety; 2005. Available at: http://www.cdc.gov/niosh/docs/2006-102/
pdfs/2006-102.pdf. Accessed August 15, 2014.
    \4\ Centers for Disease Control and Prevention. Pesticide Injury 
Surveillance: Sentinel Event Notification System for Occupational Risk 
(SENSOR) Program. July 2014. Available at http://www.cdc.gov/niosh/
topics/pesticides/overview.html. Accessed on August 16, 2014.
---------------------------------------------------------------------------
    MCN agrees with EPA that the full costs of occupational illness 
related to pesticide exposure include not only costs in medical care 
and lost productivity to workers and handlers in acute incidents, but 
also the long-term costs from the health effects of chronic exposure to 
pesticides. There is an extraordinary cost to workers, farmers and our 
society for occupational illness and injury both in the short term and 
long term in terms of medical care, lost work days, lost wages, and 
potential workers' compensation insurance premiums for an occupational 
injury or illness. While the cost of illness and injury as a result of 
work-related pesticide exposure is challenging to determine, when 
occupational illness and injury are assessed across industries, the 
cost is more than $250 billion a year. In fact, occupational injuries 
and illnesses are the second costliest medical condition behind 
cardiovascular disease and ahead of cancer.\5\ In addition, EPA is 
correct to consider the costs of illness related to exposures to 
farmworkers' families due to the pesticides that are brought home on 
workers' clothes, skin and hair.
---------------------------------------------------------------------------
    \5\ Leigh J.P. Economic burden of occupational injury and illness 
in the United States. Milbank Q. 2011; 89(4): 728-72.
---------------------------------------------------------------------------
    Preparing and Equipping Clinicians to Protect Workers: MCN applauds 
EPA's recognition that clinicians play an important role in worker 
protection. We urge EPA to help clinicians to improve their recognition 
and management of pesticide exposure by supporting the development of 
clinical diagnostic tools, and providing training and technical 
assistance for clinicians. This need is underscored in recommendations 
outlined in the 2011 Agency for Toxic Substances and Disease Registry's 
National Conversation on Public Health and Chemical Exposures Action 
Agenda. It states: ``Clinicians need a set of skills and tools for (1) 
diagnosing, treating, and intervening to prevent chemical exposures, 
(2) providing information about chemical exposures to their patients 
and communities, and (3) participating in surveillance for chemical 
exposures and health effects.'' \6\ The National Strategies for Health 
Care Providers: Pesticide Initiative, established in 1998 by EPA and 
the U.S. Departments of Health and Human Service, Agriculture, and 
Labor, also aims to improve the training of health care providers in 
the recognition, diagnosis, treatment, and prevention of pesticide 
poisonings among those who work with pesticides.\7\
---------------------------------------------------------------------------
    \6\ Agency for Toxic Substances and Disease Registry, National 
Conversation on Public Health and Chemical Exposures Action Agenda. 
2011. Available at: http://www.atsdr.cdc.gov/nationalconversation/
action_agenda.html. Accessed August 5, 2014.
    \7\ US Environmental Protection Agency, National Strategies for 
Health Care Providers: Pesticide Initiative. Available from http://
www.epa.gov/oppfead1/safety/healthcare/healthcare.htm#Cooperative. 
Accessed August 18, 2014.
---------------------------------------------------------------------------
    EPA relies on data from surveillance systems such as the SENSOR 
Pesticide Program in order to make decisions about pesticides once they 
are on the market. These systems rely in large part on reports 
submitted by healthcare providers. A well trained clinician, who 
receives education to recognize the signs and symptoms of pesticide 
exposures as well as information about where to report, is the first 
step to improve reporting. As important are clinical diagnostic tools 
to confirm a clinical impression and to help provide the objective 
confirmation of the work relatedness of an illness. Confirmatory 
diagnostic tests are essential to providing the information clinicians 
need to treat overexposed workers and handlers and to ultimately 
provide EPA with the data necessary to understand the health effects of 
registered pesticides. The Agency for Toxic Substances and Disease 
Registry, National Conversation on Public Health and Chemical Exposures 
Action Agenda also calls for clinical diagnostic tools and states: ``To 
more fully prepare healthcare providers to address chemical exposures, 
validated clinical diagnostic tools similar to blood lead testing are 
needed.'' \8\ The American Public Health Association echoes this 
recommendation as well.\9\ MCN calls for clinical diagnostic tools to 
monitor pesticide exposure. Providing clinicians with the clinical 
diagnostic tools they need to make the most accurate diagnosis possible 
should be a central part of worker protection and it is glaringly 
absent in the proposed rule.
---------------------------------------------------------------------------
    \8\ Agency for Toxic Substances and Disease Registry, National 
Conversation on Public Health and Chemical Exposures Action Agenda. 
2011. Available at: http://www.atsdr.cdc.gov/nationalconversation/
action_agenda.html. Accessed August 5, 2014.
    \9\ American Public Health Association. APHA Policy Statement 
20108: Requiring Clinical Diagnostic Tools and Biomonitoring of 
Exposures to Pesticides. Washington, D.C.: American Public Health 
Association; 2010. Available at: http://www.apha.org/advocacy/policy/
policysearch/default.htm?id=1400. Accessed August 4, 2014.
---------------------------------------------------------------------------
    Hierarchy of Controls for Occupational Health and Safety: MCN urges 
EPA to apply the standard and universally accepted public health best 
practice for control of worker exposure to chemicals--the industrial 
hygiene ``hierarchy of controls.'' Under the hierarchy of controls, 
risk reduction is based on the following preferred order of controls: 
elimination, substitution with less hazardous materials, engineering 
controls (such as closed systems), warnings, administrative control, 
and personal protective equipment.\10\ MCN is concerned that the 
revised WPS largely relies on the least protective measures for 
workers--PPE and administrative controls such as training and record 
keeping.
---------------------------------------------------------------------------
    \10\ American National Standards Institute--American Industrial 
Hygiene Association Z10-2005 Occupational Health and Safety Management 
Systems. 2005; as described in Manuele, F. ANSI/AIHA Z10-2005: The new 
benchmark for safety management systems. February 2006. Available from: 
http://www.asse.org/publications/standards/z10/docs/25-33Feb2006.pdf. 
Accessed August 5, 2014.
---------------------------------------------------------------------------
    Annual Training and Record Keeping: MCN supports annual pesticide 
safety training for farmworkers and pesticide handlers as well as a 
record-keeping system to document when these trainings take place. An 
informed workforce is an important first step in worker protection. 
Annual training will reinforce important pesticide safety practices and 
information to help workers better protect themselves and their 
families from pesticide overexposure. Studies indicate that workers who 
have been trained in the preceding year retain more information from 
new training than those whose previous training is more than two years 
old; that workers maintain information but begin to show some drop-off 
at five months; and that knowledge gains are correlated with improved 
self-reported use of PPE.11-13 Pedagogically, it is 
unreasonable to expect a workforce characterized by limited formal 
education and low levels of literacy to retain training content beyond 
one year. Training requirements to protect agricultural workers and 
handlers should be comparable to those required by OSHA regulations 
that require employers to provide annual training to protect employees 
from chemical hazardsin the workplace.
---------------------------------------------------------------------------
    \11\ Anger W.K., Patterson L., Fuchs M., Will L.L., Rohlman D.S. 
Learning and recall of Worker Protection Standard (WPS) training in 
vineyard workers. J. Agromedicine. 2009; 14(3): 336-44. doi: 10.1080/
10599240903042057.
    \12\ LePrevost C.E., Storm J.F., Asuaje C.R., Arellano C., Cope 
W.G. Assessing the effectiveness of the Pesticides and Farmworker 
Health Toolkit: A curriculum for enhancing farmworkers' understanding 
of pesticide safety concepts. J. Agromedicine. 2014; 19(2): 96-102. 
doi: 10.1080/1059924X.2014.886538.
    \13\ Levesque D.L., Arif A.A., Shen J. Effectiveness of pesticide 
safety training and knowledge about pesticide exposure among Hispanic 
farmworkers. J. Occup. Environ. Med. 2012 Dec.; 54(12): 1550-6. doi: 
10.1097/JOM.0b013e3182677d96.
---------------------------------------------------------------------------
    Training Content: MCN supports expanding the content of the 
required training for workers and handlers, underscoring the importance 
of including the proposed topics of worker rights, emergency assistance 
and ways to minimize paraoccupational exposures or pesticide ``take 
home'' exposures. Additionally, we call for EPA to emphasize training 
regarding the possible reproductive health effects of pesticide 
exposure. We also recommend that EPA be mindful of the needs of workers 
and some handlers due to low literacy and limited English language when 
revising the training standards. The training should be provided in 
meaningful interactive formats that include training in a language that 
the individual understands.
    Training Grace Period: MCN supports the elimination of a grace 
period for worker training. Any training grace period severely 
undermines the intent of the WPS. An untrained worker is more 
vulnerable to pesticide overexposure and should not be put at risk. 
OSHA standards require employers in almost all industries to notify 
their workers of the hazards that may be encountered in the workplace 
before the work begins. Agriculture should be held to the same standard 
when it comes to exposure to hazardous chemicals.
    Minimum Age--MCN supports the establishment of a minimum age of 18 
rather than the proposed minimum age limit of 16 for pesticide handlers 
and early-entry workers. Children younger than 18 are still developing 
both physically and mentally and high levels of exposure to pesticides 
could have life-long health effects. Furthermore, most minors do not 
have the maturity to follow all label instructions or take the 
necessary precautions to ensure their safety and the safety of other 
workers.14-15 Children working in other industries are 
prohibited from engaging in high hazard tasks.\16\ Children employed in 
agriculture should be afforded the same protections as children working 
in other hazardous industries.
---------------------------------------------------------------------------
    \14\ Salazar M.K., Napolitano M., Scherer J.A., and McCauley L.A. 
Hispanic adolescent farmworkers' perceptions associated with pesticide 
exposure. West J. Nurse Res. 2004; 26(2): 146-166.
    \15\ Steinberg L. Cognitive and affective development in 
adolescence. Trends in Cognitive Science. 2005; 9(2): 69-74.
    \16\ US Department of Labor. Labor Regulations, Orders and 
Statements of Interpretation.  29 CFR 570. Available from http://
www.ecfr.gov/cgi-bin/
textidx?c=ecfr&sid=48d6ee3b99d3b3a97b1bf189e1757786&rgn=div5&amp
;view= text&node=29:3.1.1.1.31&idno=29Accessed August 4, 2014.
---------------------------------------------------------------------------
    Hazard Communication--MCN does not support the EPA's proposal to 
eliminate the current requirement for a central posting location for 
pesticide application information. We do support EPA's clarification 
that this information, in addition to the Safety Data Sheets (SDSs) and 
labeling for pesticide applications, must be made available to workers' 
representatives such as clinicians, attorneys and union 
representatives. Particularly in the case of workers injured by 
pesticides, it is critical for workers' representatives to be able to 
obtain accurate, timely information about the pesticides to which 
workers may have been exposed. However, specific information about the 
pesticides applied and the hazards they pose must be made available to 
workers universally, in advance of pesticide applications. Such 
information should be available in nonemergency situations and it 
should not require any type of request from the worker or worker 
representative. Workers may not understand that they have the right to 
request such information. If workers do understand, many will be 
reluctant (for fear of job loss) or unable due to language barriers to 
ask their employer for the information.
    Additionally, we recommend requiring availability of SDSs in 
Spanish as well as English both in a central location and 
electronically using a smart phone scan code. SDSs in Spanish and other 
written languages should now be readily available, because format and 
basic content of SDSs has been harmonized internationally to comply 
with Globally Harmonized System requirements. Labels should also be 
made available electronically, as well as at a central location and 
provided in Spanish and other languages when available.
    Monitoring Handler Exposure to Cholinesterase Inhibiting 
Pesticides: We support medical monitoring of pesticide handlers who 
mix, load or apply Toxicity Category I or II organophosphates or N-
methyl carbamates. Monitoring programs have been successfully 
implemented for 40 years in California and over 10 years in Washington 
State, substantially helping to prevent overexposure of handlers. These 
biomonitoring programs have been critical in reducing overexposure by 
removing workers from ongoing exposure and identifying flaws in the 
system of worker protection.17-18
---------------------------------------------------------------------------
    \17\ Ames R.G., Brown S.K., Mengle D.C., et al. Cholinesterase 
activity depression among California agricultural pesticide 
applicators. Am. J. Ind. Med. 1989; 15(2): 143-150.
    \18\ Hofmann J.N., Keifer M.C., De Roos A.J., et al. Occupational 
determinants of serum cholinesterase inhibition among organophosphate-
exposed agricultural pesticide handlers in Washington state. Occup. 
Environ. Med. 2010;67:375-386.
---------------------------------------------------------------------------
    We strongly disagree with EPA's decision not to implement such a 
program nationwide based on its determination that these programs are 
``reactive, catching incidents after they occur rather than working to 
stop them from happening.'' This analysis contradicts some of the very 
basic tenets of public health. Medical monitoring programs are 
essential preventive measures, which successfully stop handlers from 
being overexposed by identifying subclinical evidence of exposure, 
prompting review of primary prevention practices. Medical monitoring is 
common in other industries and OSHA has promulgated over 25 specific 
standards for medical screening of workers exposed to hazardous 
substances.\19\ Pesticide handlers deserve the same protections that 
are afforded to workers in other industries. MCN recommends that EPA 
expeditiously explore a national requirement for cholinesterase 
monitoring for pesticide handlers mixing, loading or applying Category 
I or II organophosphates or N-methyl carbamates, and that the 
Washington State requirements provide a model.
---------------------------------------------------------------------------
    \19\ Occupational Safety and Health Administration. General 
Industry. Medical Screening and Surveillance.  29 CFR 1910. Available 
from https://www.osha.gov/SLTC/medicalsurveil
lance/. Accessed August 5, 2014.
---------------------------------------------------------------------------
    Emergency Assistance: MCN supports the EPA's proposal to clarify 
when employers must make transportation to a medical facility available 
to workers and handlers. However, transportation should be made 
available within 3-4 minutes if the injury is life-threatening or 15 
minutes if it is not life-threatening upon learning of an exposure, and 
not within 30 minutes. We support the proposal to require employers to 
provide to the worker, handler or the treating medical personnel the 
relevant SDS and pesticide label, or all of the pertinent information 
in an alternate form (as opposed to waiting for it to be requested). In 
certain circumstances, employers should be required to document the 
time and length of the exposure and report it to the worker and 
clinician.
    Respirator Training and Fitting: We support requiring employers of 
pesticide handlers to comply with OSHA-equivalent training on 
respirator use, fit-testing of respirators, and medical evaluation 
requirements whenever a respirator is required by the labeling. 
However, the rule should also include the OSHA requirement for each 
employer to adopt a worksite-specific respiratory protection program to 
address in detail how respirators are properly selected, cleaned, 
stored, repaired, and replaced. Furthermore, we disagree with EPA's 
decision to exclude dust or mist filtering masks, since a majority of 
pesticides with label requirements for handlers to wear respirators 
only require dust/mist filtering respirators. Medical evaluation, fit-
testing and training should be required for all types of dust/mist 
filtering respirators.
    Decontamination Supplies: We support the EPA recommendation to 
require employers to provide decontamination supplies that include one 
gallon of water per worker for routine washing and emergency eye 
flushing, soap, and single use towels and at least three gallons of 
water per worker for decontamination for workers performing tasks in an 
entry-restricted area. We also recommend that EPA require further 
decontamination supplies including shower facilities onsite. We 
recommend following the American National Standards Institute standard 
(Z358.1-2009) for emergency eyewash and shower equipment and require an 
emergency shower that can deliver water at 20 gallons per minute for 15 
minutes.\20\
---------------------------------------------------------------------------
    \20\ American National Standards Institute. American National 
Standard Z358.1-2009 for Emergency Eyewashes and Shower Equipment. 
Available at: http://webstore.ansi.org/
RecordDetail.aspx?sku=ANSI%2fISEA+Z358.1-2009. Accessed August 6, 2015. 
Described in Bradley Corporation. A Guide to the ANSI Z358.1-2009 
Standard for Emergency Eyewashes and Shower Equipment. 2012. Available 
from https://www.bradleycorp.com/download/2081/4002.pdf. Accessed 
August 6, 2014.
---------------------------------------------------------------------------
    Contaminated Personal Protective Equipment: MCN supports the EPA 
proposal to require employers to render contaminated PPE unusable 
before properly disposing of PPE that cannot be decontaminated 
according to the manufacturer's instructions. Such measures will 
prevent adverse health effects resulting from the wearing of 
contaminated garments.
    Closed Systems for Mixing and Loading: MCN supports the EPA 
proposal to clarify the criteria for closed systems by adopting the 
California standards for system design. However, EPA should go further 
and adopt, at a minimum, the California standards requiring the use of 
closed systems for highly-toxic categories of pesticides. As noted 
above, under the industrial hygiene hierarchy of controls, engineering 
controls are preferred over PPE. It therefore is appropriate for EPA to 
require the engineering control of a closed system rather than PPE as 
the primary protection for pesticide handlers. Closed systems are 
already used extensively in California, and for some pesticides and 
certain types of uses across the country. The proper use of closed 
transfer systems for mixing and loading pesticides reduces the 
potential for human exposure from spills, splashes and blowing, and 
this type of engineering control--rather than PPE--should be the first 
line of defense against pesticide exposure.
    Drift Protections: MCN supports the EPA proposal to require 
handlers to cease application if someone other than a trained and 
properly equipped handler enters treated or surrounding areas. We also 
support the establishment of entry-restricted areas adjacent to the 
treated areas in farms and forests. But, as proposed, these protections 
apply only to fields on the farm that was sprayed. This safeguard 
should extend to workers in harm's way who work at a neighboring 
establishment. Though modest in scope, the proposed entry-restricted 
areas are a step in the right direction to protect workers and others 
in the immediate vicinity of pesticideapplications.
    Early Entry Restrictions: MCN believes that early reentry for 
fieldwork should only be allowed in true agricultural emergencies. 
Worker protection during early reentry is largely dependent upon proper 
use of PPE. Many of the tasks involved with early reentry, such as 
moving irrigation pipes and performing hand labor tasks, may be 
cumbersome with required PPE. Given the nature of the tasks as well as 
the potential for escalating heat stress with PPE, there is potential 
for improper use or no use of PPE. The proposed improvements in 
training and age restriction cannot adequately mitigate these risks. In 
addition, we oppose the relaxing of the early reentry restriction for 
irrigators, allowing early reentry even if the need for irrigation 
could have been foreseen before the pesticide application. Irrigators 
are at high risk of pesticide poisoning because they tend to work long 
hours. They also often work alone with no coworker to assist in calling 
for help in case of pesticide or heat illness.
    Notification about Restricted Entry Intervals (REIs): MCN 
recommends that EPA continue to require on the sign the wording ``Keep 
Out'' and not change it to ``Entry Restricted.'' While this semantic 
change may be technically more accurate, it is far more difficult for 
most people to understand. According to a standard readability program, 
``Entry Restricted'' tests at a Grade 13 reading level. By contrast, 
``Keep Out'' tests at Grade 0, meaning that it should be easily 
understood by most six-year-olds.\21\
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    \21\ Tested using The Readability Test Tool on August 16, 2014 
available from http://read-able.com/.
---------------------------------------------------------------------------
    In conclusion, MCN applauds EPA for proposing to strengthen the WPS 
and for attempting to bring the WPS more closely into line with 
protections offered to workers in other industries. EPA can better 
protect the health and well-being of farmworkers MCN strongly urges EPA 
to act affirmatively on our recommendations to further strengthen the 
WPS.
            Sincerely,
            
            
           [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] 
            
Amy K. Liebman, M.P.A., M.A.,
Director of Environmental and Occupational Health,
512.579.4535
aliebman@migrantclinician.org


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

Karen Mountain, M.B.A., M.S.N., R.N.,
Chief Executive Officer.
                            [attachment 10]
August 17, 2014

  Hon. Gina McCarthy,
  Administrator,
  U.S. Environmental Protection Agency,
  Washington, D.C.

Re: Agricultural Worker Protection Standard Revisions; Proposed Rule 
            Docket ID # EPA-HQ-OPP-2011-0184

    Dear Administrator McCarthy,

    Thank you for the opportunity to comment on the proposed revisions 
to the Worker Protection Standard. The Farmworker Advocacy Network is a 
statewide network of organizations that work to improve living and 
working conditions of farmworkers and poultry workers in North 
Carolina.
    Farmworker Advocacy Network is pleased that the U.S. EPA has 
proposed many improvements to the WPS, which we believe will improve 
pesticide safety on the job for the 2+ million workers across the U.S. 
who harvest our food. There are several areas in which we believe that 
improvements that would strengthen the rule's effectiveness in 
preventing unnecessary pesticide exposure for migrant and seasonal 
farmworkers in North Carolina and across the U.S.

    We are concerned that the proposed rules fall short in several key 
areas:

   The proposed Minimum Age of 16 to work as a pesticide 
        handler, or as an early re-entry worker, is inappropriate and 
        unsupported by the scientific literature. We urge you most 
        strongly to adopt a minimum age of 18.

   The proposal to eliminate Central Posting does not solve the 
        need for better hazard communication. We recommend retaining 
        central posting, particularly for greenhouse and nursery 
        workers, as well as implementing more robust field posting to 
        address gaps in Hazard Communications.

    Our comments and rationale on these items and several others are 
included below. You will find citations on the last page.
Minimum Age
    The proposed minimum age of 16 to work as a pesticide handler, or 
as an early re-entry worker [ 170.9(c), 170.13(c) and 170.303)], is 
inappropriate and unsupported by the scientific literature. It is 
widely opposed by farmworkers, health care providers, and public health 
advocates. We strongly recommend a minimum age of 18.
    Pesticide handlers and early re-entry workers are at high risk of 
pesticide exposure. Working with pesticides is not appropriate work for 
youth because:

   Teens' bodies are still developing. The brain and 
        reproductive system in particular undergo significant 
        development during the teen years.i-ii Many 
        pesticides are highly toxic to the brain and to the 
        reproductive system.iii Exposing immature, 
        developing systems to pesticides can do long-term harm.

   Exposure to pesticides can increase the risk of chronic 
        diseases such as cancer iv and Parkinson's 
        Disease.v The likelihood of developing such diseases 
        later in life increases with additional years of exposure.

   Teens are capable of many jobs, but they are not yet mature 
        enough to handle highly-hazardous chemicals like pesticides. 
        Studies have shown that teens perceive themselves as less 
        vulnerable to harm, and therefore do not follow the same safety 
        precautions as adults--even when they have received the same 
        trainings.vi-vii

   Pesticide poisoning surveillance data show that youth are 
        more likely than adults to be injured by pesticides on the 
        job.viii

   In every other industry, 16 and 17 year-olds are not allowed 
        to work with hazardous chemicals.ix There is no 
        compelling reason to treat farmworker youth differently or 
        afford them a lesser level of protection on the job.

    EPA proposed a minimum age of 16, based on the higher cost of 
increasing the minimum age to 18. For a cost differential of only $10 
per year for an average farm, EPA has proposed to promulgate a standard 
that would put over 89,000 16- and 17-year-old farmworker teens at 
elevated risk of pesticide exposure, affording them a lesser level of 
protection from chemical hazards than they would receive at any other 
job.
    There is simply no viable reason to afford farmworker children a 
lesser degree of protection, as the U.S. Department of Labor does 
through its Hazardous Orders. FIFRA allows EPA to regulate child labor 
in agriculture more broadly than DOL can under the FLSA, and thus EPA 
can reach different results about when children ages 16 to 18 can do 
agricultural work involving the handling of pesticides. For DOL to 
regulate child labor, it must make a finding of particular hazard or 
detriment to health [29 U.S.C.  203(l)]; whereas EPA can regulate the 
use of pesticides to avoid ``unreasonable risk,'' broadly understood [7 
U.S.C.  136(bb)]. Because allowing children ages 16 and 17 to work as 
pesticide handlers would pose ``unreasonable risks,'' EPA is mandated 
by FIFRA to prohibit this practice as part of the Worker Protection 
Standard. The FLSA does not preempt more protective standards in other 
Federal laws. Regulations adopted by DOL under the authority of the 
FLSA provide that ``Nothing in this subpart shall authorize non-
compliance with any Federal or State law, regulation, or municipal 
ordinance establishing a higher standard. If more than one standard 
within this subpart applies to a single activity the higher standard 
shall be applicable'' [29 CFR  570.50].
    Since the founding of EPA's Office of Children's Health Protection 
in 1997, EPA has repeatedly restated its commitment to protect children 
as ``fundamental to EPA's core mission.'' x Advancing a rule 
that explicitly allows adolescents to work with high-risk materials is 
at odds with that mission, and out of step with protections for youth 
working in every other industry nationwide.
Hazard Communications
    EPA has proposed doing away with the current requirement for a 
central posting location for pesticide application information, while 
requiring that employers make the SDS and labeling for pesticide 
applications available to workers or their representatives upon request 
[ 170.11(b)]. We support EPA's clarification that this information 
must be made available to workers' representatives (whether medical 
providers, attorneys, union representatives, etc.). Particularly in the 
case of workers injured by pesticides, it is critical for workers' 
representatives to be able to obtain accurate, timely information about 
the pesticides to which workers may have been exposed. However, 
specific information about the pesticides applied and the hazards they 
pose must be made available to workers universally, in advance of 
pesticide applications. Anything less is a step backward in Hazard 
Communications.
    The proposal to maintain pesticide use records for 2 years is a 
significant improvement over the current 30-day requirement. North 
Carolina adopted a 2-year record retention requirement in 2009 in the 
wake of the Ag-Mart case [02 NCAC  9L.1402]. However, we urge the 
Agency to go further in adopting a 5-year interval, which would 
coincide with the statute of limitations for civil violations (28 
U.S.C.  2462). The cost difference for growers in maintaining records 
for five years vs. two years would be negligible.
    However, the proposal omits any record-keeping of worker re-entry 
into treated areas. In the 2006 Ag-Mart case in North Carolina, one of 
the major points at issue was whether workers were sent into fields 
before the re-entry interval (REI) had expired. EPA should require that 
employers record the date, time and field location of worker re-entry 
into treated areas, and should require that those records be maintained 
for five years (coinciding with the statute of limitations for civil 
violations). The act of recording worker re-entry into recently-treated 
fields could also serve as a deterrent that makes employers more aware 
of REIs and less likely to endanger workers' health by sending them 
into recently-treated areas too soon.
Notification to Workers and Handlers
    EPA is proposing requiring employers to post warning signs 
regarding the application of a pesticide that has an REI greater than 
48 hours (for outdoor production), or 4 hours (for enclosed space 
production) [ 170.109(a)(1)(i) and 170.109(a)(1)(ii)]. We believe 
that this change could reduce occupational pesticide illnesses. 
However, the 48-hour limit seems excessive, since as EPA notes in its 
proposal, people have difficulty remembering what they have been told 
orally. We recommend requiring both posting signs and oral warnings for 
all pesticide applications, or at a minimum for those pesticides with 
an REI of 12 hours or more. The most effective way to convey important 
information is through multiple routes, i.e., oral and written.
Training
    We strongly support the proposal to require annual training of 
workers and handlers [ 170.101(a) and 170.201(a)]. This is the 
current practice in California, and anecdotally many growers in North 
Carolina report using annual training as well. Annual training will 
decrease the likelihood that workers fail to receive critical pesticide 
safety training on the job. We also support the record-keeping and 
verification proposals [ 170.101(d) and 170.201(d)] to help employers 
and workers track compliance with the training requirement.
    However, the training grace period of two days [ 170.309], while 
an improvement over the current rule, still puts workers at serious 
risk when they begin at a new workplace. We recommend eliminating the 
grace period and requiring that pesticide safety training take place 
before any worker is put at risk of exposure on the job. There is 
currently no grace period in California, and in most other industries 
OSHA requires that employers provide safety training before employees 
begin work with potentially hazardous materials, as EPA notes in the 
proposal package [29 CFR 1910.1200(h)]. There is no compelling reason 
that the standard should be different for farmworkers.
    We strongly support the proposal that qualified trainers should 
provide WPS training to workers. However, the standard should be the 
same for pesticide handlers. [ 170.101(c)(4) and 170.201(c)(4)]. We 
question the agency's logic in deciding that for trainers of handlers, 
simple Certified Applicator status is adequate to provide an effective 
training, when that status is not adequate for trainers of workers--
especially because handlers are arguably at higher risk of exposure. 
All trainings--whether for workers or handlers--should be provided by 
someone who has proven competency in adult education techniques, in the 
language of the trainees, and cultural competence to convey the 
information effectively to the target audience. A high-quality 
nationwide train-the-trainer program can ensure these competencies.
    It is absolutely critical that workers be well-trained in pesticide 
safety. However, it is at least as important to ensure that the 
employer understand clearly the hazards of the pesticides being used 
and her/his obligations to protect workers. The WPS places a lopsided 
emphasis on training and information provision to workers, who have no 
control over the circumstances in which pesticides are used. The 
employer is the one responsible for compliance with the rule, and in 
control of whether the conditions for compliance exist, such as 
adequate PPE, decontamination supplies, etc. The rule needs a specific 
mandate for Employers and labor contractors/crew leaders to receive 
regular training on pesticide hazards and their obligations under the 
WPS. A proactive approach to training employers and crew leaders could 
help improve compliance rates, ease the transition to the changes in 
the WPS, create safer work conditions, and place the emphasis on 
compliance where it belongs--with the employer.
Prevention of Take-Home Exposure
    Training workers in preventing take-home exposure is key for better 
protecting the health and safety of workers' children and other family 
members [ 170.101(c)(2) through (3)]. However, workers will be 
severely challenged to actually carry out prevention of take-home 
exposure, since employers do not have to provide a place for workers to 
change and store clean clothes, wash clothes or take a shower before 
leaving the workplace. EPA must do more to ensure that workers can 
actually act [and] carry out the precautions and behavior changes in 
which they are trained.
    For example, EPA did not choose to propose that employers provide a 
place to shower before leaving work. How can workers be reasonably 
expected to shower before returning home if no shower is provided? On 
the [E]ast [C]oast, many migrant workers are housed in barracks or 
trailers provided by their employers. The current migrant housing 
standard in North Carolina requires employers to provide only 1 working 
shower head per 10 workers, meaning that after work many workers are 
forced to wait in long lines to remove pesticide residues. The North 
Carolina migrant housing standard does not require washing machines, or 
a ride to the local laundromat--only one ``laundry tub'' per 30 people 
for washing work clothes [NCGS  95-222:229]. Workers cannot be 
reasonably expected to wash work clothes regularly and separately from 
other laundry under such conditions. We recommend that EPA require 
employers to provide such facilities at the worksite that would enable 
compliance with safety training:

   Showers with separate stalls or privacy screens;

   A changing area with lockers to store clean clothes; and

   Washing machines designated for work clothes, or regular 
        access to a nearby laundromat or other similarly-equipped 
        facility.

    Training workers on these safety topics is futile without the 
facilities to actually comply.
    As EPA moves forward with this new rule and begins to consider 
implementation and training, we hope that you will reach out to us for 
assistance. Developing and field-testing strong new training and 
compliance materials will be key to this rule's success in both 
preventing hazardous pesticide exposure for workers and their families, 
and minimizing the challenges of compliance for growers. Farmworker 
Advocacy Network's members stand ready to assist you.
    Thank you for the opportunity to provide comments on the proposal 
to revise the agricultural Worker Protection Standard. We congratulate 
EPA for taking this major step forward, and look forward to working 
with you to ensure pesticide safety in the workplace.
            Sincerely,
            [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
            
Melinda Wiggins, Executive Director, Student Action with Farmworkers.
On behalf of Farmworker Advocacy Network.
[References]
    i Lebel and Beaulieu. ``Longitudinal Development of 
Human Brain Wiring Continues from Childhood into Adulthood.'' The 
Journal of Neuroscience, July 27, 2011. 31(30): 10937-10947.
    ii Medline Plus, ``Adolescent Development.'' U.S. 
National Library of Medicine, National Institutes of Health. http://
www.nlm.nih.gov/medlineplus/ency/article/002003.htm (accessed 3/17/
2014).
    iii Roberts and Reigart. ``Chapter 21: Chronic Effects'' 
in Recognition and Management of Pesticide Poisonings, Sixth Edition. 
2013. U.S. EPA Publication number 735K13001.
    iv Bassil, et al. ``Cancer health effects of pesticides: 
Systematic review'' Canadian Family Physician. October 2007 vol. 53 no. 
10 1704-1711.
    v Kamel, et al. ``Pesticide Exposure and Self-reported 
Parkinson's Disease in the Agricultural Health Study'' Am. J. 
Epidemiol. 2007; 165: 364-374.
    vi Salazar, et al. 2004. ``Hispanic Adolescent 
Farmworkers' perceptions associated with pesticide exposure.'' West J. 
Nurse Res. 26(2): 146-166.
    vii Steinberg, 2005. ``Cognitive and affective 
development in adolescents.'' Trends in Cognitive Sciences, February 
2005 vol. 9 no. 2 69-74.
    viii Calvert, et al. 2003. ``Acute pesticide poisoning 
among agricultural workers in the United States 1998-2005.'' Am. J. 
Ind. Med. 51(12): 883-898.
    ix ``Youth & Labor: Hazardous Jobs'' United States 
Department of Labor. http://www.dol.gov/dol/topic/youthlabor/
harzardousjobs.htm (accessed 3/17/2014).
    x U.S. EPA Office of Children's Health Protection 
website. http://www.yosemite.epa.gov/ochp/ochpweb.nsf/content/
homepage.htm (accessed 4/25/2014).
                            [attachment 11]
August 14, 2014

  Hon. Gina McCarthy,
  Administrator,
  U.S. Environmental Protection Agency,
  Washington, D.C.

Re: Agricultural Worker Protection Standard Revisions; Docket ID # EPA-
            HQ-OPP-2011-0184

    Dear Administrator McCarthy:

    Thank you for the opportunity to comment on the proposed revisions 
to the Worker Protection Standard. I write on behalf of the American 
Public Health Association, a diverse community of public health 
professionals who champion the health of all people and communities. 
APHA and its 53 affiliated state and regional public health 
associations represent 50,000 public health professionals. APHA brings 
a 140+ year perspective from all fields of public health, including 
occupational health and safety, environmental health, children's health 
and immigrant health. APHA firmly believes that the occupational health 
and safety of workers is a public health priority, and we have a long 
history of supporting measures to protect workers and improve 
occupational health and safety.
    We write to support many aspects of the proposed WPS that foster 
worker health and safety for an estimated 2 million workers across the 
United States who harvest our food. These workers, the majority of whom 
are immigrants from Mexico and other Central American countries, are 
the most overexposed population to pesticides.
    Prevention of occupational disease, injury and exposure is 
fundamental to worker health and safety. APHA believes the protection 
of agricultural workers and their families, immigrant workers, 
including farmworkers, and workers exposed to pesticides is a critical 
public health concern and believes stronger, protective measures are 
urgently needed.1-5
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    \1\ American Public Health Association. APHA Policy Statement 96-
06: The Precautionary Principle and Chemical Exposure Standards for the 
Workplace. 1996. Available at: www.apha.org/advocacy/policy/
policysearch/default.htm?id=124. Accessed August 4, 2014.
    \2\ American Public Health Association. APHA Policy Statement 2005-
4: Occupational Health and Safety Protections for Immigrant Workers. 
2005. Available at: http://www.apha.org/advocacy/policy/policysearch/
default.htm?id=1318. Accessed August 4, 2014.
    \3\ American Public Health Association. APHA Policy Statement 
20108: Requiring Clinical Diagnostic Tools and Biomonitoring of 
Exposures to Pesticides. Washington, D.C.: American Public Health 
Association; 2010. Available at: http://www.apha.org/advocacy/policy/
policysearch/default.htm?id=1400. Accessed August 4, 2014.
    \4\ American Public Health Association. APHA Policy Statement 
201110: Ending Agricultural Exceptionalism: Strengthening Worker 
Protection in Agriculture through Regulation, Enforcement, Training, 
and Improved Worksite Health and Safety. American Public Health 
Association; 2011. Available at: http://www.apha.org/advocacy/policy/
policysearch/default.htm?id=1420. Accessed August 4, 2014.
    \5\ American Public Health Association. APHA Policy Statement 2005-
06: Reducing occupational exposure to benzene in workers and their 
offspring. Available at: http://www.apha.org/advocacy/policy/
policysearch/default.htm?id=1322. Accessed August 4, 2014.
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    More importantly, we wish to underscore the standard and 
universally accepted public health best practice for control of worker 
exposure to chemicals--the industrial hygiene ``hierarchy of 
controls.'' Under the hierarchy of controls, risk reduction is based on 
the following preferred order of controls: elimination, substitution 
with less hazardous materials, engineering controls (such as closed 
systems), warnings, administrative control, and personal protective 
equipment.\6\ While we commend the U.S. Environmental Protection Agency 
for proposing to strengthen the WPS, we are concerned that the revised 
WPS largely relies on the least protective measures for workers--PPE 
and administrative controls. We therefore urge EPA to apply the 
hierarchy of controls principle to strengthen protections for 
farmworkers.
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    \6\ American National Standards Institute--American Industrial 
Hygiene Association Z10-2005 Occupational Health and Safety Management 
Systems. 2005; as described in Manuele, F. ANSI/AIHA Z10-2005: The new 
benchmark for safety management systems. February 2006. Available from: 
http://www.asse.org/publications/standards/z10/docs/25-33Feb2006.pdf. 
Accessed on August 5, 2014.
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    We also emphasize the public health benefit of preventing injury, 
illness and exposure. While there are costs associated with the 
protection of this important and vulnerable workforce, there is also an 
extraordinary cost to workers, farmers and our society for occupational 
illness and injury in terms of medical care, lost work days, lost 
wages, and potential workers' compensation insurance premiums for an 
occupational injury or illness. At the price of more than $250 billion 
a year, occupational conditions are the second costliest medical 
condition behind cardiovascular disease and ahead of cancer.\7\ The 
cost of illness and injury as a result of work-related pesticide 
exposure is challenging to assess. This is largely due to the current 
weaknesses in our regulations, formal and informal exclusions from the 
workers' compensation systems, challenges in clinically confirming the 
diagnosis of pesticide poisonings, lack of understanding regarding 
incident reporting as well as patchwork surveillance systems. 
Additionally, many workers do not report overexposures as they do not 
understand their rights and fear losing their jobs. Prevention policies 
and programs are cost-effective, reduce health care costs, and can 
improve productivity.
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    \7\ Leigh J.P. Economic burden of occupational injury and illness 
in the United States. Milbank Q. 2011; 89(4): 728-72.
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    Detailed below are the areas of the rule that we strongly support, 
and those areas in need of strengthening in order to better protect 
farmworkers.
    Training Frequency--APHA supports annual pesticide safety training 
for farmworkers and pesticide handlers. An informed workforce is an 
important first step in worker protection. Annual training will 
reinforce important pesticide safety practices and information to help 
workers better protect themselves and their families from pesticide 
overexposure. Studies indicate that workers who have been trained in 
the preceding year retain more information from new training than those 
whose previous training is more than two years old; that workers 
maintain information but begin to show some drop-off at five months; 
and that knowledge gains are correlated with improved self-reported use 
of PPE.8-10    Pedagogically, it is unreasonable to expect a 
workforce characterized by limited formal education and low levels of 
literacy to retain training content beyond one year. Moreover, workers 
in most other industries receive annual safety training and farmworkers 
deserve the same protection.
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    \8\ Anger W.K., Patterson L., Fuchs M., Will L.L., Rohlman D.S. 
Learning and recall of Worker Protection Standard (WPS) training in 
vineyard workers. J. Agromedicine. 2009; 14(3): 336-44. doi: 10.1080/
10599240903042057.
    \9\ LePrevost C.E., Storm J.F., Asuaje C.R., Arellano C., Cope W.G. 
Assessing the effectiveness of the Pesticides and Farmworker Health 
Toolkit: a curriculum for enhancing farmworkers' understanding of 
pesticide safety concepts. J. Agromedicine. 2014; 19(2): 96-102. doi: 
10.1080/1059924X.2014.886538.
    \10\ Levesque D.L., Arif A.A., Shen J. Effectiveness of pesticide 
safety training and knowledge about pesticide exposure among Hispanic 
farmworkers. J. Occup. Environ. Med. 2012 Dec.; 54(12): 1550-6. doi: 
10.1097/JOM.0b013e3182677d96.
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    Training Content--APHA supports expanding the content of the 
required training for workers and handlers, underscoring the importance 
of including the proposed topics of worker rights, emergency assistance 
and ways to minimize paraoccupational exposures or pesticide ``take 
home'' exposures. Additionally, we call for the EPA to emphasize 
training regarding the possible reproductive health effects of 
pesticide exposure. We also recommend that EPA be mindful of the needs 
of workers and some handlers due to low income, low literacy and 
limited English language when revising the training standards. The 
training should be provided in meaningful interactive formats that 
include training in a language that the individual understands.
    Training Grace Period--APHA supports the elimination of a grace 
period for worker training. Any training grace period severely 
undermines the intent of the WPS. An untrained worker is more 
vulnerable to pesticide overexposure and should not be put at risk.
    Minimum Age--APHA supports the establishment of a minimum age of 18 
rather than the proposed minimum age limit of 16 for pesticide handlers 
and early-entry workers. Children younger than 18 are still developing 
both physically and mentally, and high levels of exposure to pesticides 
could have life-long health effects. Furthermore, most minors do not 
have the maturity to follow all label instructions or take the 
necessary precautions to ensure their safety and the safety of other 
workers.11-12  Children working in other industries are 
prohibited from engaging in high hazard tasks.\13\ Children employed in 
agriculture should be afforded the same protections as children working 
in other hazardous industries.
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    \11\ Salazar M.K., Napolitano M., Scherer J.A., and McCauley L.A. 
Hispanic adolescent farmworkers' perceptions associated with pesticide 
exposure. West J. Nurse Res. 2004; 26(2): 146-166.
    \12\ Steinberg L. Cognitive and affective development in 
adolescence. Trends in Cognitive Science. 2005; 9(2): 69-74.
    \13\ U.S. Department of Labor. Labor Regulations, Orders and 
Statements of Interpretation.  29 CFR 570. Available from http://
www.ecfr.gov/cgi-bin/text-
idx?c=ecfr&sid=48d6ee3b99d3b3a97b1bf189e1757786&rgn=div5&vie
w=text& node=29:3.1.1.1.31&idno=29. Accessed August 4, 2014.
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    Hazard Communication--APHA does not support EPA's proposal to 
eliminate the current requirement for a central posting location for 
pesticide application information. We support EPA's clarification that 
this information, in addition to the Safety Data Sheets and labeling 
for pesticide applications, must be made available to workers' 
representatives such as clinicians, attorneys and union 
representatives. Particularly in the case of workers injured by 
pesticides, it is critical for workers' representatives to be able to 
obtain accurate, timely information about the pesticides to which 
workers may have been exposed. However, specific information about the 
pesticides applied and the hazards they pose must be made available to 
workers universally, in advance of pesticide applications. Such 
information should be available in nonemergency situations and it 
should not require any type of request from the worker or worker 
representative. Workers may not understand that they have the right to 
request such information. If workers do understand, many will be 
reluctant (for fear of job loss) or unable due to language barriers to 
ask their employer for the information.
    Additionally, we recommend requiring availability of SDSs in 
Spanish as well as English both in a central location and 
electronically using a smart phone scan code. SDSs in Spanish and other 
written languages should now be readily available, because format and 
basic content of SDSs has been harmonized internationally to comply 
with Globally Harmonized System requirements. Labels should also be 
made available electronically, as well as at a central location and 
provided in Spanish and other languages when available.
    Monitoring Handler Exposure to Cholinesterase Inhibiting 
Pesticides--APHA supports medical monitoring of pesticide handlers who 
mix, load or apply Toxicity Category I or II organophosphates or N-
methyl carbamates. Monitoring programs have been successfully 
implemented for 40 years in California and over 10 years in Washington 
State, substantially helping to prevent overexposure of handlers. We 
strongly disagree with EPA's decision not to implement such a program 
nationwide based on its determination that these programs are 
``reactive, catching incidents after they occur rather than working to 
stop them from happening.'' This analysis contradicts some of the very 
basic tenets of public health. Medical monitoring programs are 
essential preventive measures, which successfully stop handlers from 
being overexposed by identifying subclinical evidence of exposure, 
prompting review of primary prevention practices. Medical monitoring is 
common in other industries and OSHA has promulgated over 25 specific 
standards for medical screening of workers exposed to hazardous 
substances.\14\ Pesticide handlers deserve the same protections that 
are afforded to workers in other industries.
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    \14\ Occupational Safety and Health Administration. General 
Industry. Medical Screening and Surveillance.  29 CFR 1910. Available 
from https://www.osha.gov/SLTC/medicalsurveil
lance/. Accessed on August 5, 2014.
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    Clinical Diagnostic Tools and Monitoring Workers for Pesticide 
Exposure--APHA believes biomonitoring is critical to protecting 
agriculture workers from over exposure to pesticides.\15\ Health care 
providers have few clinical diagnostic tools readily available to help 
to better recognize and manage pesticide exposures. Additional 
information offered by a confirmatory diagnostic test is essential in 
providing information clinicians need to treat overexposed workers and 
handlers and to ultimately provide EPA with frontline data necessary to 
understand the health effects of registered pesticides. Providing 
clinicians with the clinical diagnostic tools they need to make the 
most accurate diagnosis possible should be a central part of worker 
protection, a feature that is glaringly absent in the proposed rule. 
The Agency for Toxic Substance and Disease Registry, National 
Conversation on Public Health and Chemical Exposures Action Agenda, 
also calls for clinical diagnostic tools and states: ``To more fully 
prepare healthcare providers to address chemical exposures, validated 
clinical diagnostic tools similar to blood lead testing are needed.'' 
\16\
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    \15\ American Public Health Association. APHA Policy Statement 
20108: Requiring Clinical Diagnostic Tools and Biomonitoring of 
Exposures to Pesticides. Washington, D.C.: American Public Health 
Association; 2010. Available at: http://www.apha.org/advocacy/policy/
policysearch/default.htm?id=1400. Accessed August 4, 2014.
    \16\ Agency for Toxic Substance and Disease Registry, National 
Conversation on Public Health and Chemical Exposures Action Agenda. 
2011. Available at: http://www.atsdr.cdc.gov/nationalconversation/
action_agenda.html. Accessed August 5, 2014.
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    Emergency Assistance--APHA supports EPA's proposal to clarify when 
employers must make transportation to a medical facility available to 
workers and handlers. However, transportation should be made available 
within 3-4 minutes if the injury is life-threatening or 15 minutes if 
it is not life-threatening upon learning of an exposure, and not within 
30 minutes. We support the proposal to require employers to provide to 
the worker, handler or the treating medical personnel the relevant SDS 
and pesticide label, or all of the pertinent information in an 
alternate form (as opposed to waiting for it to be requested). In 
certain circumstances, employers should be required to document the 
time and length of the exposure and report it to the worker and 
clinician.
    Informed and Prepared Clinicians--APHA applauds EPA's recognition 
that clinicians play an important role in worker protection. In 
addition to requiring employers to provide treating medical personnel 
with pertinent pesticide exposure information, we urge EPA to consider 
further measures. EPA should help clinicians to improve their 
recognition and management of pesticide overexposure by (1) supporting 
the development of clinical diagnostic tools, and (2) providing 
training and technical assistance for clinicians. A survey of 
environmental medicine content in U.S. medical schools found that 75 
percent of schools require only about seven hours of study in 
environmental medicine over four years.\17\ Not surprisingly, 
clinicians are often unprepared to recognize, manage, or help prevent 
exposure-related illness. APHA echoes the recommendation outlined in 
the ATSDR National Conversation on Public Health and Chemical Exposures 
Action Agenda that ``Clinicians need a set of skills and tools for (1) 
diagnosing, treating, and intervening to prevent chemical exposures, 
(2) providing information about chemical exposures to their patients 
and communities, and (3) participating in surveillance for chemical 
exposures and health effects.'' \18\
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    \17\ Schenk M., Popp S.M., Neale A.V., Demers R.Y. Environmental 
medicine content in medical school curricula. Acad. Med. 1996 May; 
71(5): 499-501.
    \18\ Agency for Toxic Substance and Disease Registry, National 
Conversation on Public Health and Chemical Exposures Action Agenda. 
2011. Available at: http://www.atsdr.cdc.gov/nationalconversation/
action_agenda.html. Accessed August 5, 2014.
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    Respirator Training and Fitting--APHA supports requiring employers 
of pesticide handlers to comply with OSHA-equivalent training on 
respirator use, fit-testing of respirators, and medical evaluation 
requirements whenever a respirator is required by the labeling. 
However, the rule should also include the OSHA requirement for each 
employer to adopt a worksite-specific respiratory protection program to 
address in detail how respirators are properly selected, cleaned, 
stored, repaired, and replaced. Furthermore, we disagree with EPA's 
decision to exclude dust or mist filtering masks, since a majority of 
pesticides with label requirements for handlers to wear respirators 
only require dust/mist filtering respirators. Medical evaluation, fit-
testing and training should be required for all types of dust/mist 
filtering respirators.
    Decontamination Supplies--APHA supports the EPA recommendation to 
require employers to provide decontamination supplies that include one 
gallon of water per worker for routine washing and emergency eye 
flushing, soap, and single use towels and at least three gallons of 
water per worker for decontamination for workers performing tasks in an 
entry-restricted area. We also recommend that EPA require further 
decontamination supplies including shower facilities onsite. We 
recommend following the American National Standard Institute standard 
(Z358.1-2009) for emergency eyewash and shower equipment and require an 
emergency shower that can deliver water at 20 gallons per minute for 15 
minutes.\19\
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    \19\ American National Standards Institute . American National 
Standard Z358.1-2009 for Emergency Eyewashes and Shower Equipment. 
Available at: http://webstore.ansi.org/
RecordDetail.aspx?sku=ANSI%2fISEA+Z358.1-2009. Accessed August 6, 2014. 
Described in Bradley Corporation. A Guide to the ANSI Z358.1-2009 
Standard for Emergency Eyewashes and Shower Equipment. 2012. Available 
from https://www.bradleycorp.com/download/2081/4002.pdf. Accessed 
August 6, 2014.
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    Contaminated Personal Protective Equipment--APHA supports the EPA 
proposal to require employers to render contaminated PPE unusable 
before properly disposing of PPE that cannot be decontaminated 
according to the manufacturer's instructions. Such measures will 
prevent adverse health effects resulting from the wearing of 
contaminated garments.
    Closed Systems for Mixing and Loading--APHA supports the EPA 
proposal to clarify the criteria for closed systems by adopting the 
California standards for system design. However, EPA should go further 
and adopt, at a minimum, the California standards requiring the use of 
closed systems for highly-toxic categories of pesticides. As noted 
above, under the industrial hygiene hierarchy of controls, engineering 
controls are preferred over PPE. It therefore is appropriate for EPA to 
require the engineering control of closed system as the primary 
protection for pesticide handlers rather than PPE. Closed systems are 
already used extensively in California, and for some pesticides and 
certain types of uses across the country. The proper use of closed 
transfer systems for mixing and loading pesticides reduces the 
potential for human exposure from spills, splashes and blowing, and 
this type of engineering control--rather than PPE--should be the first 
line of defense against pesticide exposure.
    Drift Protections--APHA supports the EPA proposal to require 
handlers to cease application if someone other than a trained and 
properly equipped handler enters treated or surrounding areas. We also 
support the establishment of entry-restricted areas adjacent to the 
treated areas in farms and forests. But, as proposed, these protections 
apply only to fields on the farm that was sprayed. This safeguard 
should extend to workers in harm's way who work at a neighboring 
establishment. Though modest in scope, the proposed entry-restricted 
areas are a step in the right direction to protect workers and others 
in the immediate vicinity of pesticide applications.
    Early Entry Restrictions--APHA believes that early reentry for 
fieldwork should only be allowed in true agricultural emergencies. 
Worker protection during early reentry is largely dependent upon proper 
use of PPE. Many of the tasks involved with early reentry such as 
moving irrigation pipes and performing hand labor tasks may be 
cumbersome with required PPE. Given the nature of the tasks as well as 
the potential for escalating heat stress with PPE, there is potential 
for improper use or no use of PPE. The proposed improvements in 
training and age restriction cannot adequately mitigate these risks. In 
addition, we oppose the relaxing of the early reentry restriction for 
irrigators, allowing early reentry even if the need for irrigation 
could have been foreseen before the pesticide application. Irrigators 
are at high risk of pesticide poisoning because they tend to work long 
hours. They also often work alone with no coworker to assist in calling 
for help in case of pesticide or heat illness.
    In conclusion, APHA strongly urges you to adopt these 
recommendations to strengthen the WPS. EPA can better protect the 
health and well-being of farmworkers by bringing the WPS more closely 
into line with protections offered to workers in other economic 
sectors.
            Sincerely,
            [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
            
Georges C. Benjamin, M.D.,
Executive Director.
                            [attachment 12]
August 15, 2014

  Hon. Gina McCarthy,
  Administrator,
  U.S. Environmental Protection Agency,
  Washington, D.C.

Re: Docket ID No. EPA-HQ-OPP-2011-0184, Agricultural Worker Protection 
            Standard Revisions

    Dear Administrator McCarthy:

    Our firm represents and submits these comments on behalf of the 
Coalition of Florida Farmworker Organizations (CoFFO) of Florida City, 
Florida. CoFFO is a statewide organization whose main objective is to 
enhance the living and working conditions of migrant and seasonal 
farmworkers and the rural poor in Florida.
    These comments are submitted in response to the Environmental 
Protection Agency's (``EPA'') proposed regulatory changes to the Worker 
Protection Standard Revisions, 79 Fed. Reg. 15444, 15449 (proposed Mar. 
19, 2014) While the proposed rule makes important improvements to the 
outdated and inadequate current version of the worker protection 
standards, it falls short in a number of respects in providing maximum 
feasible protection to farmworkers and their families. Notably, the 
proposed rule leaves farmworkers with considerably fewer protections 
against exposure to dangerous chemicals and toxic substances in the 
workplace than those enjoyed by nonagricultural workers.
    The EPA worker protection standards are of great importance to the 
estimated 250,000 workers employed in Florida's fields, groves, 
greenhouses, nurseries and forests. Because of its hot, humid 
subtropical climate, Florida uses a greater quantity of pesticides per 
acre than any other state. The use of pesticides, herbicides and 
fungicides is greatest in the state's nurseries, which employ an 
estimated 100,000 workers, a disproportionate number of whom are women 
of child-bearing age, and where the risks of exposure are increased by 
the contained or enclosed work areas.
    Worker surveys indicate that pesticide misuse is widespread in 
Florida. Nearly \1/2\ (48.3%) of over 400 crop workers in south Florida 
surveyed in 1980 reported that they had been directly sprayed with 
agricultural chemicals at least once while working. See Danger in the 
Field: The Myth of Pesticide Safety, Florida Rural Legal Services, Inc. 
(May 1980), at 1.\1\ However, relatively few pesticide incidents are 
reported to the state Department of Agriculture and Consumer Services, 
and those that are reported rarely result in meaningful sanctions to 
employers who misuse pesticides. See Indifference to Safety: Florida's 
Investigations into Pesticide Poisoning of Farmworkers, Farmworker 
Justice Fund and Florida Legal Services (February 1998). Enhanced 
protections and increased worker training are important in addressing 
these longstanding problems.
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    \1\ There is evidence that these problems have not abated since the 
adoption of the Worker Protection Standards. In 2005, 84 employees of 
Ag-Mart Produce, Inc., one of the nation's largest grape tomato 
producers, were interviewed following the widely-reported incidence of 
three of its employees bearing children with severe birth defects. 
Nearly \1/4\ (22%) of the respondents reported being sprayed directly 
during the prior month, with 40% claiming during that same period that 
they were exposed to pesticides through drift. See Ag-Mart worker 
survey, Florida Legal Services (June 2005).
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    The proposed rules should be based on several fundamental 
principles:

    Federal WPS standards should not be less than state standards.

    At a minimum, the Worker Protection Standards should be at least as 
stringent as state law. In the past, variances between the WPS and 
Florida law have led to confusion among both farmworkers and their 
employers. The proposed rule should adopt as an absolute floor state 
requirements regarding pesticide use. For example, Florida law 
prohibits minors (under 18) from handling pesticides. See  
450.061(2)(c), Fla. Stat. (``No minor under 18 years of age . . . shall 
be employed or permitted to suffer to work in any of the following 
places of employment . . . [i]n and around toxic substances or 
corrosives, including pesticides or herbi-
cides . . .'')

    Protections against exposure to pesticides [for] farmworkers should 
be no less than corresponding OSHA provisions regarding use of toxic 
substances in nonagricultural workplaces.

    Based on years of studies and its regulatory experience, the 
Occupational Safety and Health Administration (OSHA) has established 
detailed standards regarding the use of toxic substances in the 
workplace. No principled reason exists for the WPS to provide 
farmworkers with lower level of protection than required for 
nonagricultural workers under the OSHA regulations.\2\ Unfortunately, 
the proposed regulations fall short of the OSHA minimums in a number of 
important respects. Among other things:
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    \2\ We commend the agency for those portions of the proposed 
regulations that bring the protection of farmworkers into conformity 
with those extended to other workers. For example, the proposed 
regulation requires annual retraining of workers, similar to the 
mandates of OSHA with respect to nonagricultural workers regularly 
exposed to chemical hazards. Similarly, the proposed rule allowing for 
the authorized representatives of farmworkers to obtain pesticide 
information is consistent with the rights workers have to obtain 
information regarding occupational hazards under the OSHA. See 29 CFR 
1910.1020(e)(1) (allowing access to a worker or his ``designated 
representative,'' defined as ``any individual or organization to whom 
an employee gives written authorization to exercise a right of 
access,'' and providing that a collective bargaining agent may obtain 
such records without written authorization).

   Mandated closed systems are required by OSHA in many 
        situations and similar requirements should be required for the 
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        mixing of pesticides.

   The protections in the proposed regulations are noticeably 
        less than those required under OSHA'[s] respiratory protection 
        program for dust- and mist-filtering respirators.

   Emergency showers should be available in the work area when 
        there is bodily contact with pesticides, as is required by the 
        OSHA.

   In instances of suspected pesticide exposures, the proposed 
        regulations provide employers with a 30 minute grace period 
        before arranging for medical care. OSHA requires that workers 
        be immediately transported to a health care facility in such 
        situations, and the same protocol should be followed with 
        respect to farmworkers displaying symptoms of pesticide 
        poisoning.

   OSHA requires that workers be provided training regarding 
        hazardous chemicals in the workplace before employment begins. 
        The proposed regulations provide a grace period of several days 
        during which a farmworker can be employed prior to receiving 
        training regarding pesticides. There is no principled basis for 
        denying farmworkers the same right to pre-employment training 
        that is extended to nonagricultural workers.

   Farmworkers who seek to assert or enforce their rights under 
        the WPS are not afforded the same protections against 
        retaliation as workers have under the Occupational Safety and 
        Health Act.

   While proposed rule represents a marked improvement over the 
        current regulations regarding record-keeping and record 
        retention, it stops stop well short of the obligations imposed 
        by the OSHA regulations. As part of its effort to ``detect[], 
        treat[] and prevent[] . . . occupational disease,'' see 29 CFR 
         1910.1020(a), OSHA requires that records of employee exposure 
        be maintained for at least 30 years. See 29 CFR  
        1910.1020(d)(ii). There is no reason that pesticide application 
        records should be retained for any shorter period, especially 
        given that many of the long-term effects of pesticide poisoning 
        do not manifest themselves for many years after the exposure. 
        Furthermore, the proposed regulation is silent as to charges 
        for providing the information available to workers. Consistent 
        with the OSHA regulations, the proposed regulation should 
        expressly provide that this information will be provided to the 
        farmworker or his representative free of charge, as is the case 
        under the OSHA regulations. See 29 CFR  1910.1020(e)(1)(iii).

    Information must be made available in a manner that is accessible 
to and easily understood by farmworkers.

    While the proposed regulations increase workers' access to 
information regarding pesticide applications, they omit provisions that 
would greatly enhance the usefulness of this information to 
farmworkers. Notably, the proposed regulation does not require the 
basic application information be provided in any foreign language. For 
the enhanced disclosures to be meaningful, it is imperative that the 
information be conveyed in a fashion that is comprehensible to the 
workers. The vast majority of farmworkers in both Florida and 
nationwide speak little or no English. See Daniel Carroll, et al., 
Changing Characteristics of U.S. Farm Workers: 21 Years of Findings 
from the National Agricultural Workers Survey (May 12, 2011), at 10 
(finding that 62% of current farmworkers speak little or no English). 
Other farmworker protective laws require that essential information be 
provided in the worker's native language. See Migrant and Seasonal 
Agricultural Worker Protection Act, 29 U.S.C.  1821(g) and 29 CFR  
500.78 (requiring information regarding job terms and housing 
conditions to be disclosed in writing in a language in which the worker 
is fluent). There is no reason to require an employer to disclose the 
wages and job terms to a worker in his native tongue while not also 
requiring vital health information regarding pesticide applications to 
be provided in the vernacular.
    The proposed regulation removes the current requirement that 
mandates posting of pesticide application information in a central 
location. Posting in this fashion eliminates the need for a farmworker 
to confront his employer with a request for data, greatly reducing the 
chances of retaliation. We urge that the current posting requirements 
be retained. Farmworkers are reluctant to approach their employers to 
request information because of the widespread practice of retaliation 
against farmworkers perceived as potential troublemakers. See, e.g., 
Fanette v. Steven Davis Farms, LLC, 2014 WL 2961239, at *16 (N.D. Fla., 
July 1, 2014); Castillo v. Case Farms of Ohio, Inc., 96 F. Supp. 2d 
578, 631 (W.D. Tex. 1999), Bertrand v. Jorden, 672 F. Supp. 1417, 1425 
(M.D. Fla. 1987).
    Thank you for your consideration of our views.
    [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
    
Gregory S. Schell,
Attorney at Law.
                            [attachment 13]
Received May 5, 2014
April 29, 2014

  Hon. Gina McCarthy,
  Administrator,
  U.S. Environmental Protection Agency,
  Washington, D.C.

RE: Docket Number: EPA-HQ-OPP-2011-0184 (Pesticides; Agricultural 
            Worker Protection Standard Revisions)

    Dear Administrator McCarthy:

    On behalf of Telamon Corporation I am writing to express our 
organization's strong support for the proposed revisions to the Worker 
Protection Standard for Agricultural Pesticides (WPS). We deeply 
appreciate your consideration of our comments.
    With the support of a grant from the United States Department of 
Labor through the National Farmworker Jobs Program (NFJP), we provide 
critical job training to migrant and seasonal farmworkers to help them 
secure more stable and self- and family-sustaining employment. In doing 
so, our organization actively seeks to engage eligible members of this 
population by going into communities, often before and after working 
hours and on weekends, to make them aware of the opportunities we 
provide. We then work closely with program participants to help them 
complete training and find gainful employment that provides for them a 
more stable future. We are proud of the success we have had in this 
work and that of the program in its entirety. Nationally, NFJP 
continues to be one of the highest performing training programs at the 
Labor Department.
    Because of our extensive, close work with farmworkers, we believe 
that we know better than most about just how important these WPS 
revisions are to farmworkers. Our organization fully supports these 
changes because of the greater protections they will bring to the 
vulnerable migrant and seasonal farmworker population. In particular, 
we are especially happy to see the following changes proposed:

   Yearly trainings for farmworkers. As you know, current 
        regulations require training only every five years. Again, 
        because of our work with farmworkers, we see firsthand the 
        turnover in this population. As a result, we consistently find 
        farmworkers who have received little, if any, pesticide-safety 
        training.

   Added emphasis on take-home exposure for farmworker 
        families. Several years ago, our member organization, the 
        Association of Farmworker Opportunity Programs (AFOP), 
        developed a curriculum to educate farmworkers about the dangers 
        of pesticide residue on clothing and equipment returned to the 
        home at the end of each work day. Using excellent low-literacy 
        materials to communicate this message, AFOP members have 
        trained thousands of farmworkers on limiting this take-home 
        exposure, greatly benefitting workers' families. While AFOP is 
        pleased with that impact, it knows that many tens of thousands 
        more suffer in ignorance of this threat to their homes and 
        families.

   Actions to reduce spray drift, especially near farmworker 
        housing, schools, and playgrounds. Spray drift is also a danger 
        farmworkers face routinely. While we acknowledge the common use 
        of pesticides, we also recognize the simple precautions 
        proposed by this new rule will better protect farmworkers from 
        overspray and fumes.

   More stringent requirements for treated areas and improved 
        notification for early-entry workers. Again, we see these as 
        common sense precautions that will help preserve the health and 
        safety of laborers.

   Making available to farmworkers or their advocates 
        (including medical personnel) information specific to the 
        pesticide application, including the pesticide label and Safety 
        Data Sheets. Working with farmworkers firsthand, we see 
        consistently the barriers they face in working in the United 
        States agricultural sector. Oftentimes, an inability to speak 
        or understand the English language makes it difficult for these 
        workers to communicate effectively with employers and 
        understand sufficiently the information provided them. 
        Accordingly, making this critical information available to 
        advocates, including medical personnel, will allow these 
        laborers to call on a family friend to communicate and better 
        explain matters on their behalf. Importantly, it will also 
        allow doctors, nurses and first-responders to better understand 
        the nature of injuries through ready access to pesticide 
        information.

    On the topic of minimum age for pesticide handling, we understand 
the revisions would allow for a person as young as 16 years of age to 
handle pesticides. AFOP believes that 18 years of age would be a more 
appropriate age for that kind of work, and will state so in its 
comments. AFOP will also work with its collegial advocacy groups and 
the medical community to better demonstrate why the age change is 
warranted.
    In closing, we would like to thank you for putting forward these 
important changes, and look forward to their quick adoption.
            Sincerely,
            [GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
            
Don Kuchnicki,
State Director.
                            [attachment 14]
    [http://www.statutes.legis.state.tx.us/Docs/AG/htm/AG.125.htm]
Texas Agriculture Code
Title 5. Production, Processing, and Sale of Horticultural Products
Subtitle G. Workplace Chemicals
Chapter 125. Agricultural Hazard Communication Act
    Sec. 125.001. Declaration of Purpose. The legislature finds that 
the health and safety of persons living and working in agricultural 
areas in the state may be improved by providing access to information 
regarding certain hazardous chemicals to which they may be exposed 
either during their normal employment activities, during emergency 
situations, or as a result of proximity to the use of those chemicals. 
The legislature also finds that, because of the conditions of 
agricultural employment, there is a unique situation regarding certain 
agricultural laborers that makes it necessary to establish formal 
procedures to provide access to information regarding certain hazardous 
chemicals and to assure those laborers that there will be no 
retaliation by the employer for the exercise of rights under this 
chapter. This chapter is intended to assure that accessibility to 
information regarding chemicals covered by this chapter be provided to 
agricultural laborers who may be exposed to those chemicals in 
agricultural workplaces, to certain emergency service organizations 
responsible for dealing with chemical hazards during emergency 
situations when those chemicals are in close proximity to residential 
areas, and to the department to make the information available to the 
general public through specific procedures.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.002. Definitions. In this chapter:

          (1) ``Agricultural laborer'' means a person who plants, 
        cultivates, harvests, or handles an agricultural or 
        horticultural commodity in its unmanufactured state as 
        determined by rule of the department, and includes an 
        agricultural laborer who handles a chemical covered by this 
        chapter. Office workers, cooks, maintenance workers, security 
        personnel, and nonresident management are not agricultural 
        laborers, except for purposes of a gross annual payroll 
        determination, unless their job performance routinely involves 
        potential exposure to chemicals covered under this chapter. 
        Farm and ranch laborers working solely with livestock and 
        persons working solely in the retail sales component of a 
        business are not agricultural laborers for purposes of this 
        chapter.
          (2) ``Chemical name'' means the scientific designation of a 
        chemical in accordance with the nomenclature system developed 
        by the International Union of Pure and Applied Chemistry 
        (IUPAC) or the Chemical Abstracts Service (CAS) rules of 
        nomenclature, or a name that will clearly identify the chemical 
        for the purpose of conducting a hazard evaluation.
          (3) ``Common name'' means any designation of identification 
        such as code name, code number, trade name, brand name, or 
        generic name used to identify a chemical other than by its 
        chemical name.
          (4) ``Chemical manufacturer'' means an employer in Standard 
        Industrial Classification (SIC) Codes 20 through 39.
          (5) ``Designated representative'' means the individual or 
        organization to whom an agricultural laborer gives written 
        authorization to exercise the laborer's rights under this 
        chapter. A designated representative is not required to reveal 
        the name of the agricultural laborer he represents if the 
        department has reviewed the laborer's written authorization, 
        certifies that the representative has that authorization, and 
        determines that the agricultural laborer would be entitled to 
        the information the designated representative is seeking to 
        obtain. A recognized or certified collective bargaining agent 
        shall be treated automatically as a designated representative 
        without regard to written authorization from a laborer.
          (6) ``Distributor'' means any business, other than a chemical 
        manufacturer or importer, that supplies chemicals covered by 
        this chapter to other distributors or to purchasers.
          (7) ``Expose'' or ``exposure'' means that an agricultural 
        laborer is subjected to a chemical covered by this chapter in 
        the course of employment through any route of entry, including 
        inhalation, ingestion, skin contact, or absorption, and 
        includes potential, possible, or accidental exposure.
          (8) ``Fire chief'' means the elected or paid administrative 
        head of a fire department as defined in Chapter 125 (http://
        www.statutes.legis.state.tx.us/
        GetStatute.aspx?Code=AG&Value=125), Acts of the 45th 
        Legislature, Regular Session, 1937 (Article 6243e (http://
        www.statutes.legis.state.tx.us/
        GetStatute.aspx?Code=CV&Value=6243e), Vernon's Texas Civil 
        Statutes).
          (9) ``Label'' means any written, printed, or graphic material 
        displayed on or affixed to containers of chemicals covered by 
        this chapter.
          (10) ``Material safety data sheet'' (``MSDS'') means a 
        document containing chemical hazard and safe handling 
        information that is prepared in accordance with the 
        requirements of the Occupational Safety and Health 
        Administration (OSHA) standard for that document or, in the 
        case of a chemical labeled under the Federal Insecticide, 
        Fungicide, and Rodenticide Act (7 U.S.C. Section 136 et seq.) 
        for which an MSDS is both unavailable and not required under 
        the Federal OSHA's hazard communication standard, a product 
        label or other equivalent document with precautionary 
        statements, such as hazards to humans and domestic animals, and 
        environmental, physical, or chemical hazards, including warning 
        statements.
          (11) ``Work area'' means a room, defined space, or field 
        where chemicals covered by this chapter are stored or used and 
        where agricultural laborers may be present.
          (12) ``Workplace'' means a geographical location containing 
        one or more work areas.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.003. Application. (a) This chapter applies only to the 
following employers who annually use or store any one of the chemicals 
covered by this chapter in excess of 55 gallons or 500 pounds or an 
amount that the department determines by rule for certain highly toxic 
or dangerous chemicals covered by this chapter:

          (1) employers who themselves or through labor agents hire 
        agricultural laborers to perform seasonal or migrant work and 
        whose gross annual payroll for those laborers is $15,000 or 
        more; and
          (2) employers who themselves or through labor agents hire 
        agricultural laborers for purposes other than seasonal or 
        migrant work and whose gross annual payroll for those laborers 
        is $50,000 or more.

    (b) This chapter applies only to the following chemicals:

          (1) chemicals labeled under the Federal Insecticide, 
        Fungicide, and Rodenticide Act (7 U.S.C. Section 136 et seq.); 
        and
          (2) fertilizers with chemicals that are listed or defined as 
        hazardous chemicals in 29 CFR Section 1910.1200(c) or 
        1910.1200(d)(3), including those listed or defined in 
        subsequent comparable regulations.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.004. Workplace Chemical List. (a) An employer covered by 
this chapter shall compile and maintain a workplace chemical list on a 
form prescribed by the department that contains the following 
information by crop for each chemical covered by this chapter that is 
actually used or stored annually in the workplace in excess of 55 
gallons or 500 pounds or an amount that the department determines by 
rule for certain highly toxic or dangerous chemicals covered by this 
chapter:

          (1) the product name used on the MSDS and container label and 
        the Environmental Protection Agency registration number, if 
        applicable;
          (2) the date and crop on which the chemical was applied or 
        used; and
          (3) the work area in which the chemical is actually stored or 
        used.

    (b) The employer shall update the workplace chemical list as 
necessary but not less frequently than annually.
    (c) The workplace chemical list may be prepared for the workplace 
as a whole or for each work area and must be readily available to 
agricultural laborers and their designated representatives. New or 
newly assigned agricultural laborers shall be made aware of the 
workplace chemical list before working with chemicals covered by this 
chapter or in a work area containing those chemicals.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.005. Workplace Chemical List Form, Maintenance, and 
Access. (a) The department shall prescribe forms for workplace chemical 
lists required by this chapter with places to indicate the crop, the 
product name of the chemical that is applied to the crop or that is 
stored, and the location and date of its application, use, or storage, 
as appropriate.
    (b) An employer covered by this chapter shall maintain one form for 
each crop, work area, or workplace as a whole, as appropriate, and 
shall add information to the form as different chemicals are applied, 
used, or stored.
    (c) The employer shall attach relevant information to the form, 
including MSDSs.
    (d) The employer shall keep the forms and attachments accessible 
and available for copying and shall store them in a location suitable 
to preserve their physical integrity.
    (e) The employer shall keep the forms and attachments under this 
chapter for 30 years. However, the department shall provide by rule 
that an employer may file with the department annually the forms and 
attachments, including an estimate of the total amount of each chemical 
listed on the form that was used. The department shall categorize and 
cross-reference the data on the forms in a manner to preserve the data 
for future medical use. An employer who files the forms and attachments 
with the department under rules adopted under this section is not 
required to preserve the forms.
    (f) If it is determined after a hearing conducted under Section 
12.032 (http://www.statutes.legis.state.tx.us/
GetStatute.aspx?Code=AG&Value=12.032) that an employer has repeatedly 
failed to maintain the forms and attachments as required, the 
department may require the employer to file the documents with the 
department. In addition, the person may be subject to any applicable 
penalties provided by this chapter.
    (g) If agricultural activities for which forms and attachments are 
maintained cease at a workplace, the forms and attachments shall be 
filed with the department, and the department shall retain the 
information for 30 years. If an employer covered by this chapter is 
succeeded or replaced in that function by another person, the person 
who succeeds or replaces the employer shall retain the forms as 
provided by Subsection (e) of this section but is not liable for 
violations committed by the former employer under this chapter or rules 
adopted under this chapter, including violations relating to the 
retention and preservation of forms and attachments.
    (h) Except as otherwise provided by this section, the employer 
shall show the forms and attachments, on request, to an employee, 
designated representative, treating medical personnel, or a member of 
the community. The designated representative or treating medical 
personnel are not required to identify the employee represented or 
treated. If the employer has filed the forms and attachments with the 
department, the employer shall inform the requestor of that fact.
    (i) If a designated representative or member of the community 
desires a copy of a form and attachments and the employer refuses to 
provide a copy, that person shall notify the department of the request 
and the employer's refusal. Within two working days, the department 
shall request that the employer provide the department with all 
pertinent copies. The employer shall provide copies of the form and 
attachments to the department within 24 hours after the department's 
request if a designated representative desires the copies, and within 
14 days after the department's request if a member of the community 
desires the copies.
    (j) The employer may not refuse to provide the forms and 
attachments to an employee or treating medical personnel.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988. Amended by Acts 1995, 74th Leg., ch. 419, Sec. 3.25, eff. 
        Sept. 1, 1995.

    Sec. 125.006. Material Safety Data Sheets. (a) Chemical 
manufacturers and distributors shall provide appropriate MSDSs to 
purchasers in this state of chemicals covered by this chapter.
    (b) Employers covered by this chapter shall maintain the most 
current MSDS received from manufacturers or distributors for each 
purchased chemical covered by this chapter. If an MSDS has not been 
provided by the manufacturer or distributor for chemicals on the 
workplace chemical list at the time the chemicals are received at the 
workplace, the employer shall request one in writing from the 
manufacturer or distributor in a timely manner. This chapter does not 
require an employer who is not a chemical manufacturer to create an 
MSDS.
    (c) The department may require any person who has or obtains a 
registration for a pesticide under Sections 76.041-76.048 of this code 
to provide with the registration a copy of the most current and 
complete MSDS for that pesticide.
    (d) The department by rule may require chemical manufacturers to 
submit MSDSs for chemicals covered by this chapter, excluding chemicals 
covered by Subsection (c) of this section.
    (e) All MSDSs in the files of the department are public records.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1.

    Sec. 125.007. Labels. (a) Existing labels on incoming containers of 
chemicals covered by this chapter may not be removed or defaced.
    (b) Agricultural laborers may not be required to work with a 
chemical covered by this chapter from an unlabeled container except for 
a portable container intended for the immediate use of the laborer who 
performs the transfer.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.008. Emergency Information. (a) Employers covered by this 
chapter and other entities who normally store products labeled under 
the Federal Insecticide, Fungicide, and Rodenticide Act (7 U.S.C. 
Section 136 et seq.) in an amount in excess of 55 gallons or 500 pounds 
or an amount the department determines by rule for certain highly toxic 
or dangerous chemicals covered by this chapter within \1/4\ mile of a 
residential area composed of three or more private dwellings shall 
provide to the fire chief of the fire department having jurisdiction 
over the storage place, in writing, the names and telephone numbers of 
knowledgeable representatives of the employer or other entity storing 
the product who can be contacted for further information or contacted 
in case of an emergency.
    (b) Each employer, on request, shall provide a copy of the 
workplace chemical list to the fire chief having jurisdiction over the 
storage place. The employer shall notify the fire chief of any 
significant changes that occur in the workplace chemical list.
    (c) The fire chief having jurisdiction over the storage place or 
his representative, on request, shall be permitted to conduct on-site 
inspections of the chemicals on the workplace chemical list for the 
sole purpose of preparing fire department activities in case of an 
emergency.
    (d) Employers shall provide to the fire chief having jurisdiction 
over the storage place, on request, a copy of the MSDS for any chemical 
on the workplace chemical list.
    (e) On request, the fire chief having jurisdiction over the storage 
place shall make the workplace chemical list and MSDSs available to 
members of the fire department having jurisdiction over the workplace 
and to other personnel outside the fire department who are responsible 
for preplanning emergency activities, but may not otherwise distribute 
the information without approval of the employer.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.009. Training Program Provided By Department. (a) The 
department in conjunction with the Texas Agricultural Extension Service 
shall develop an on-going training program for agricultural laborers. 
The program must provide information the department considers 
appropriate, and must include:

          (1) information on interpreting labels and MSDSs and the 
        relationship between those two methods of hazard communication;
          (2) information on the proper storage, acute and chronic 
        effects, and safe handling of chemicals covered by this 
        chapter;
          (3) information on protective clothing and equipment and 
        first aid treatment to be used with respect to the chemicals 
        covered by this chapter; and
          (4) general safety instructions on the handling, cleanup 
        procedures, and disposal of chemicals covered by this chapter.

    (b) The department shall provide the training program in counties 
with a hired farm labor work force of 2,000 or more, according to the 
most recent United States Census of Agriculture. The department by rule 
may determine to provide the training program in additional counties 
with a significant farm labor work force or based on other relevant 
factors. In all other counties, the county office of the Texas 
Agricultural Extension Service shall provide the training program.
    (c) The department or the county office of the Texas Agricultural 
Extension Service, as appropriate, shall notify agricultural laborers 
on a regular basis of the training program by public service 
announcements given by the media and shall contact in writing 
charitable, public, religious, and health care provider organizations 
to announce the training program to agricultural laborers in the county 
served by the organization.
    (d) In addition to the Texas Agricultural Extension Service, the 
department may develop the training program in conjunction with the 
Texas Department of Health, other appropriate state agencies, clinics, 
hospitals, and other health care providers in counties in which the 
training program will be conducted, and organizations representing 
employers, organizations representing employees, and organizations 
representing manufacturers of chemicals covered by this chapter.
    (e) The department shall prepare and make available to employers 
appropriate training materials for employers covered by this chapter 
and their managers and labor contractors.
    (f) To help cover production costs, the department may charge not 
more than $10 plus the cost of a blank videotape from a person desiring 
to purchase the videotaped training program.
    (g) The department or the county office of the Texas Agricultural 
Extension Service, as appropriate, shall provide to each agricultural 
laborer who completes the training program a card evidencing 
participation in the program. An employer may not refuse to hire an 
agricultural laborer solely because the laborer does not have a card 
issued under this subsection. An employer who refuses to hire an 
agricultural laborer for that reason is not entitled to the 14 days' 
written notice provided by Section 125.016(d) (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=AG&
Value=125.016) of this code.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.010. Crop Sheet Developed By Department. (a) The 
department shall develop crop sheets that contain the following 
information:

          (1) the kinds of chemicals typically used on a particular 
        crop;
          (2) the typical time a chemical is applied to a particular 
        crop;
          (3) general safety information, including information on 
        general hygiene, clothing, contact with chemicals, medical 
        symptoms, pregnancy, and other relevant safety data;
          (4) a notice of the training programs and the counties in 
        which the programs will be conducted;
          (5) the availability of MSDSs for chemicals used on a 
        particular crop;
          (6) the means of locating emergency medical information;
          (7) agricultural laborers' rights under this chapter;
          (8) the name and telephone number of the person to contact 
        for information under this chapter;
          (9) the appropriate telephone number for emergency 
        information; and
          (10) any other safety or health-related information the 
        department considers relevant.

    (b) The information on the crop sheet must be printed in English 
and Spanish, except that the information required by Subsections (a)(1) 
and (a)(2) of this section is required to be printed only in English. 
The department may provide crop sheets printed in other languages 
commonly used by agricultural laborers who work with a particular crop.
    (c) The department shall develop the crop sheets in conjunction 
with the Texas Department of Health, the Texas Agricultural Extension 
Service, other appropriate state agencies, and clinics, hospitals, and 
other health care providers in counties in which training programs are 
provided by the department under Section 125.009 (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=AG&Value=125.009) 
of this code.
    (d) Annually, the department shall:

          (1) provide appropriate crop sheets to clinics, hospitals, 
        and other health care providers that serve agricultural 
        laborers and that are located in counties in which the training 
        program is provided; and
          (2) provide to an employer covered by this chapter one crop 
        sheet for each crop grown by that employer.

    (e) The director of the Texas Feed and Fertilizer Control Service 
under Section 63.003 (http://www.statutes.legis.state.tx.us/
GetStatute.aspx?Code=AG&Value=
63.003) of this code shall provide to the department the information 
that is needed by the department under Subsection (a) of this section 
for the fertilizers that are covered by this chapter.
    (f) For purposes of developing crop sheets under this chapter and 
complying with other provisions of this chapter, nursery stock, stored 
grain, and other logical groupings may be considered a single crop as 
determined by rules adopted by the department.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.011. Crop Sheet Provided By Employer. (a) An employer 
covered by this chapter shall provide crop sheets to each agricultural 
laborer pertaining to the crops that laborer will be working with if:

          (1) the laborer does not have a card issued under Section 
        125.009(g)
        (http://www.statutes.legis.state.tx.us/
        GetStatute.aspx?Code=AG&Value=
        125.009) of this code; or
          (2) the laborer requests the crop sheets.

    (b) An employer who is required under Subsection (a) of this 
section to provide crop sheets to an agricultural laborer shall ensure 
that the information on a crop sheet required by Sections 
125.010(a)(3), (a)(4), and (a)(10) (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=AG&Value=125.010) 
of this code that pertains to the crops with which the laborer will be 
working is read to the laborer at least once each work season. When the 
crop sheet is read, the employer or the employer's agent shall inform 
the laborer of the date on which chemicals covered by this chapter were 
last applied or are scheduled to be applied to the field or to other 
areas in which the laborer will be working and shall inform the laborer 
of the time on which the reentry period, if any, expired for chemicals 
covered by this chapter that have been applied.
    (c) If an employer is required under Subsection (b) of this section 
to read a crop sheet to an agricultural laborer, the employer or a 
person designated by the employer shall read the appropriate crop 
sheets on the first day of each work season or on the day the laborer 
begins employment with that employer, whichever is later.
    (d) In addition to the crop sheet, the department shall require an 
employer to offer to the agricultural laborer, on the day on which the 
laborer is given his first pay for that work season, basic safety and 
health-related information approved by the department. That information 
shall be available to the employers free of charge.
    (e) An employer who does not provide or read the crop sheets as 
required by this section is not entitled to the 14 days' written notice 
provided by Section 125.016(d) (http://www.statutes.legis.state.tx.us/
GetStatute.aspx?Code=AG&Value=125.016) of this code.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.012. Protective Clothing. An employer covered by this 
chapter shall provide any protective clothing or device that is 
recommended by the MSDS, crop sheet, or department rule and that is in 
addition to the standard long-sleeved shirt, long pants, boots or 
shoes, and socks normally provided by the agricultural laborer.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.013. Rights of Agricultural Laborers. (a) Agricultural 
laborers employed by employers covered by this chapter who may be 
exposed to chemicals covered by this chapter shall be informed of the 
exposure and shall have access to the workplace chemical list and MSDSs 
for those chemicals. Laborers, on request, shall be provided a copy of 
a specific MSDS. In addition, laborers shall receive training on the 
hazards of the chemicals and on measures they can take to protect 
themselves from those hazards and shall be provided with appropriate 
personal protective equipment as required by this chapter. These rights 
are guaranteed on January 1, 1988.
    (b) An employer covered by this chapter may not discharge, cause to 
be discharged, otherwise discipline, or in any manner discriminate 
against an agricultural laborer because the laborer has made an 
inquiry, filed a complaint, assisted an inspector of the department who 
may make or is making an inspection under Section 125.016 (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=AG&Value=
125.016) of this code, instituted or caused to be instituted any 
proceeding under or related to this chapter, testified or is about to 
testify in such a proceeding, or exercised any rights afforded under 
this chapter on behalf of the laborer or on behalf of others. Pay, 
position, seniority, or other benefits may not be lost as the result of 
the exercise of any right provided by this chapter.
    (c) Any waiver by an agricultural laborer of the benefits or 
requirements of this chapter is against public policy and is void. Any 
employer's request or requirement that a laborer waive any rights under 
this chapter as a condition of employment is a violation of this 
chapter.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.014. Department Rules; Outreach Program. (a) The 
department may adopt rules and administrative procedures reasonably 
necessary to carry out the purposes of this chapter.
    (b) The department shall develop and provide to each employer 
covered by this chapter a suitable form of notice providing 
agricultural laborers with information regarding their rights under 
this chapter.
    (c) As part of an outreach program, the department shall develop 
and distribute a supply of informational leaflets on employers' duties, 
agricultural laborers' rights, the public's ability to obtain 
information under this chapter, the outreach program, and the effects 
of chemicals covered by this chapter.
    (d) The department may contract with a public institution of higher 
education or other public or private organizations to develop and 
implement the outreach program.
    (e) The department shall publicize the availability of information 
to answer inquiries from agricultural laborers, employers, or the 
public in this state concerning the effects of chemicals covered by 
this chapter.
    (f) In cooperation with the department, an employer covered by this 
chapter may provide an outreach program in the community.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.015. Liability Under Other Laws. (a) The provision of 
information to an agricultural laborer does not in any way affect the 
liability of an employer with regard to the health and safety of a 
laborer or other person exposed to chemicals, nor does it affect the 
employer's responsibility to take any action to prevent the occurrence 
of occupational disease as required under any other provision of law.
    (b) The provision of information to an agricultural laborer does 
not affect any other duty or responsibility of a manufacturer, 
producer, or formulator to warn ultimate users of a chemical under any 
other provision of law.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988.

    Sec. 125.016. Complaints, Investigations, and Penalties. (a) 
Complaints received in writing from agricultural laborers or their 
designated representatives relating to alleged violations of this 
chapter by employers covered by this chapter shall be investigated in a 
timely manner by the department as provided by this section.
    (b) Officers or representatives of the department, on presentation 
of appropriate credentials, have the right of entry into any workplace 
at reasonable times to inspect and investigate complaints for purposes 
of determining compliance with this chapter.
    (c) The department shall complete an investigation of a complaint 
not later than 90 days after the date on which the complaint is filed. 
A hearing shall be conducted under Section 12.032 (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=
AG&Value=12.032) and an enforcement order issued, if appropriate, not 
later than 90 days after the date on which the investigation is 
completed. If it is necessary to commence an action relating to an 
alleged violation, the action must be commenced not later than 60 days 
after the date on which the investigation is completed.
    (d) After providing at least 14 days' written notice and an 
opportunity for a public hearing, the department may issue an 
enforcement order requiring any employer or chemical manufacturer 
covered by this chapter to comply with this chapter or rules adopted 
under this chapter. A public hearing held under this subsection is a 
contested case under Chapter 2001 (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=GV&Value=2001), 
Government Code, and may be appealed under that chapter. In the case of 
a medical emergency, the department may issue an enforcement order 
immediately and shall provide the opportunity for a hearing on the 
order within 10 days after the date on which the order is issued.
    (e) In the case of a medical emergency, the department may sue in 
the name of the State of Texas to enjoin any violation of this chapter 
or a rule adopted or enforcement order issued by the department under 
this chapter.
    (f) If required under this chapter, employers who knowingly 
disclose false information or negligently fail to disclose a hazard are 
subject to a civil penalty of not more than $5,000 per violation. This 
section does not affect any other right of an agricultural laborer or 
any other person to receive compensation for damages under other law.
    (g) If required under this chapter, employers who proximately cause 
an injury to an individual by knowingly disclosing false hazard 
information or knowingly failing to disclose hazard information are 
subject to a criminal fine of not more than $25,000. This section does 
not affect any other right of an agricultural laborer or any other 
person to receive compensation for damages under other law.
    (h) The department may request the attorney general to represent 
the department in any legal proceeding authorized under this chapter. 
An action for civil or criminal penalties or injunctive relief shall be 
brought in the county in which the alleged violation occurred or is 
occurring.
    (i) Each violation of this chapter or a rule adopted under this 
chapter constitutes a separate offense.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988. Amended by Acts 1995, 74th Leg., ch. 76, Sec. 5.95(49), 
        eff. Sept. 1, 1995; Acts 1995, 74th Leg., ch. 419, Sec. 3.26, 
        eff. Sept. 1, 1995.

    Sec. 125.017. Compliance With Hazard Communication Act. (a) If an 
employer is required to comply with Chapter 502 (http://
www.statutes.legis.state.tx.us/GetStatute.aspx?Code=HS&Value=502), 
Health and Safety Code and with this chapter, the employer is required 
to comply with only the Hazard Communication Act. However, if an 
agricultural laborer is not covered under the Hazard Communication Act, 
the employer shall comply with this chapter for those laborers not 
covered by the Hazard Communication Act.
    (b) If an employer is covered by both the Hazard Communication Act 
and this chapter, the employer is required to furnish a workplace 
chemical list under only one of those laws.

          Added by Acts 1987, 70th Leg., ch. 903, Sec. 1, eff. Jan. 1, 
        1988. Amended by Acts 1991, 72nd Leg., ch. 14, Sec. 284(92), 
        eff. Sept. 1, 1991.

          [Accessed September 8, 2016]
                            [attachment 15]
    [http://www.cdpr.ca.gov/docs/legbills/calcode/030302.htm#a67231]
California Code of Regulations (Title 3. Food and Agriculture)
Division 6. Pesticides and Pest Control Operations
Chapter 3. Pest Control Operations
Subchapter 3. Pesticide Worker Safety
    Article 2. General Safety Requirements

6723.1. Application-Specific Information For Handlers.
    (a) The operator of property used for the commercial or research 
production of an agricultural plant commodity shall display, at a 
central location, the following application-specific information while 
employees are employed to handle pesticides:

          (1) Identification of the treated area;
          (2) Time and date of the application;
          (3) Restricted entry interval; and
          (4) Product name, EPA registration number, and active 
        ingredients.

    (b) The information shall be displayed within 24 hours of the 
completion of an application and include all applications that have 
been made to any treated field on the agricultural establishment within 
\1/4\ mile of where employees will be working. Once displayed, the 
information shall remain displayed until the area no longer meets the 
definition of a treated field or handler employees will no longer be on 
the establishment, whichever occurs earlier.
    (c) The original or copies of documents otherwise required to be 
maintained by this chapter may be used to meet the requirements of this 
Section provided they contain the information required by this Section.

          Note: Authority cited: Section 12981, Food and Agricultural 
        Code.
          Reference: Sections 11501, 12973, 12980, and 12981, Food and 
        Agricultural Code.
6761. Hazard Communication for Field Workers.
    (a) Whenever employees are working as field workers in a treated 
field, the employer shall display at the worksite, a copy of a 
completed written Hazard Communication Information for Employees 
Working in Fields (Pesticide Safety Information Series leaflet A-9). In 
the event that fieldworkers gather at a central location prior to 
transportation to the worksite, the Pesticide Safety Information Series 
leaflet A-9 may instead be displayed at that central location. 
Pesticide Safety Information Series leaflet A-9 shall be written by the 
department in English and Spanish. Upon request, the employer shall 
read to the requesting employee, in a language understandable to that 
employee, Pesticide Safety Information Series leaflet A-9. Pesticide 
Safety Information Series leaflets are available from the Department.
    (b) The operator of the property shall maintain in a central 
location at the workplace accessible to employees, including the 
employees of labor contractors, who enter a treated field, the 
following:

          (1) pesticide use records specified in section 6624(b), (c), 
        (d) and (e) for pesticides that have been applied to the field 
        within the last two years;
          (2) a Safety Data Sheets (SDS), as specified in Title 8, 
        California Code of Regulations, section 5194, for each 
        pesticide listed in the pesticide use records referred to in 
        subsection (b)(1). If the SDS is not provided by the registrant 
        of a pesticide, the operator of the property shall:

                  (A) within 7 working days of a request for a SDS from 
                an employee, employee representative or employee's 
                physician, make written inquiry to the registrant of 
                the pesticide, asking that a SDS be sent to the 
                operator of the property. If the operator of the 
                property has made a written inquiry within the last 12 
                months as to whether the pesticide is subject to the 
                requirement for a SDS or the operator of the property 
                has made a written inquiry within the last 6 months 
                requesting new, revised or later information on the 
                SDS, the operator of the property need not make 
                additional written inquiry. A copy of the written 
                inquiry shall immediately be sent to the person 
                requesting the SDS;
                  (B) notify the requester of the availability of the 
                SDS or provide a copy of the SDS to the requester 
                within 15 days of receipt of the SDS from the 
                registrant; and
                  (C) if a response has not been received from the 
                registrant within 25 working days of the date the 
                inquiry was made, send the department a copy of the 
                inquiry with a notation that no response has been 
                received. The operator of the property is not precluded 
                from obtaining and providing the SDS utilizing other 
                more expedient methods in lieu of those provided in 
                this subsection.

    (c) The operator of the property shall inform his or her employees, 
before they are allowed to enter a treated field, of the location and 
availability of any records and other documents required by subsections 
(a) and (b). If the employees are employed by a labor contractor, the 
operator of the property shall inform the labor contractor of the 
location, or changed location, of the records and other documents. The 
labor contractor shall provide that information to his or her 
employees. If the location of the records and other documents changes, 
the operator of the property and the labor contractor shall promptly 
inform his or her employees of the new location. The employer, 
including the labor contractor, shall also inform their employees that 
they, their physicians and their representatives have a right of access 
to the information and that the employees are protected against 
discharge or other discrimination due to the exercise of their rights 
under this section.
    (d) The operator of the property shall provide, upon request of his 
or her employee, an employee of a labor contractor, employee 
representative, or an employee's physician, access to any records, 
documents and information required to be maintained by this chapter. 
Access shall be granted as soon as possible and not to exceed 48 hours 
from the date of the request.

          Informational Note: Other requirements relating to hazard 
        communication can be found in sections 6602, 6618, 6619, 6724, 
        6726, 6738, 6744, 6764, 6766, 6770, 6771, and 6776.
          Note: Authority cited: Section 12981, Food and Agricultural 
        Code.
          Reference: Sections 12980 and 12981, Food and Agricultural 
        Code; and 29 Code of Federal Regulations, Part 1910.1200.
6761.1. Application-Specific Information for Fieldworkers.
    (a) The operator of property used for the commercial or research 
production of an agricultural plant commodity shall display at a 
central location the following application-specific information, while 
fieldworkers are employed to work in treated fields on the operator's 
property:

          (1) Identification of the treated field;
          (2) Time and date of the application;
          (3) Restricted entry interval;
          (4) Product name(s), U.S. EPA registration number(s), and 
        active ingredient(s); and
          (5) Spray adjuvant product name(s) and California 
        registration number(s) if applicable.

    (b) The information must be displayed when the operator of the 
property receives notice of the completion of an application and before 
any fieldworkers are allowed to enter the treated field. The 
information must include all applications that have been made to any 
field on the operator's property. The information must remain displayed 
until the area no longer meets the definition of a treated field or 
fieldworkers will no longer be on the operator's property, whichever 
occurs earlier.
    (d) * The operator of the property and any employer with 
fieldworkers hired to work on the operator's property, shall display, 
at the worksite or at a central location where fieldworkers gather, a 
description of the location of the application-specific information 
display whenever their fieldworkers are working in a treated field. The 
description of the location must be specific enough for fieldworkers to 
find and have unimpeded access to the displayed application-specific 
information. The location description must be included in the 
appropriate section of, or as an attachment to, the Hazard 
Communication Information for Employees Working in Fields (Pesticide 
Safety Information Series leaflet A-9) pursuant to section 6761(a).
---------------------------------------------------------------------------
    * Editor's note: the entries on the California Government website 
are reproduced herein as is. Technically, paragraph (d) should follow 
paragraph (c).
---------------------------------------------------------------------------
    (c) * The original or copies of documents otherwise required to be 
maintained by this chapter may be used to meet the requirements of this 
Section, provided they contain the information required by this 
Section.

          Note: Authority cited: Section 12981, Food and Agricultural 
        Code.
          Reference: Sections 11501, 12973, 12980, and 12981, Food and 
        Agricultural Code.

          [Accessed September 8, 2016]
                            [attachment 16]
    [http://www.ecfr.gov/cgi-bin/text-
idx?c=ecfr&sid=d452215d50193ecd758dc85
dc47b5e7c&rgn=div8&view=text&node =29:6.1.1.1.1.1.1.20&idno=29]

    e-CFR data is current as of September 8, 2016.
29 CFR Labor
Subtitle B--Regulations Relating to Labor (Continued)
Chapter XVII--Occupational Safety and Health Administration, Department 
        of Labor (Continued)
Part 1910--Occupational Safety and Health Standards (Continued)
    Subpart Z--Toxic and Hazardous Substances
1910.1020  Access to employee exposure and medical records.
    (a) Purpose. The purpose of this section is to provide employees 
and their designated representatives a right of access to relevant 
exposure and medical records; and to provide representatives of the 
Assistant Secretary a right of access to these records in order to 
fulfill responsibilities under the Occupational Safety and Health Act. 
Access by employees, their representatives, and the Assistant Secretary 
is necessary to yield both direct and indirect improvements in the 
detection, treatment, and prevention of occupational disease. Each 
employer is responsible for assuring compliance with this section, but 
the activities involved in complying with the access to medical records 
provisions can be carried out, on behalf of the employer, by the 
physician or other health care personnel in charge of employee medical 
records. Except as expressly provided, nothing in this section is 
intended to affect existing legal and ethical obligations concerning 
the maintenance and confidentiality of employee medical information, 
the duty to disclose information to a patient/employee or any other 
aspect of the medical-care relationship, or affect existing legal 
obligations concerning the protection of trade secret information.
    (b) Scope and application. (1) This section applies to each general 
industry, maritime, and construction employer who makes, maintains, 
contracts for, or has access to employee exposure or medical records, 
or analyses thereof, pertaining to employees exposed to toxic 
substances or harmful physical agents.
    (2) This section applies to all employee exposure and medical 
records, and analyses thereof, of such employees, whether or not the 
records are mandated by specific occupational safety and health 
standards.
    (3) This section applies to all employee exposure and medical 
records, and analyses thereof, made or maintained in any manner, 
including on an in-house of contractual (e.g., fee-for-service) basis. 
Each employer shall assure that the preservation and access 
requirements of this section are complied with regardless of the manner 
in which the records are made or maintained.
    (c) Definitions--(1) Access means the right and opportunity to 
examine and copy.
    (2) Analysis using exposure or medical records means any 
compilation of data or any statistical study based at least in part on 
information collected from individual employee exposure or medical 
records or information collected from health insurance claims records, 
provided that either the analysis has been reported to the employer or 
no further work is currently being done by the person responsible for 
preparing the analysis.
    (3) Designated representative means any individual or organization 
to whom an employee gives written authorization to exercise a right of 
access. For the purposes of access to employee exposure records and 
analyses using exposure or medical records, a recognized or certified 
collective bargaining agent shall be treated automatically as a 
designated representative without regard to written employee 
authorization.
    (4) Employee means a current employee, a former employee, or an 
employee being assigned or transferred to work where there will be 
exposure to toxic substances or harmful physical agents. In the case of 
a deceased or legally incapacitated employee, the employee's legal 
representative may directly exercise all the employee's rights under 
this section.
    (5) Employee exposure record means a record containing any of the 
following kinds of information:

          (i) Environmental (workplace) monitoring or measuring of a 
        toxic substance or harmful physical agent, including personal, 
        area, grab, wipe, or other form of sampling, as well as related 
        collection and analytical methodologies, calculations, and 
        other background data relevant to interpretation of the results 
        obtained;
          (ii) Biological monitoring results which directly assess the 
        absorption of a toxic substance or harmful physical agent by 
        body systems (e.g., the level of a chemical in the blood, 
        urine, breath, hair, fingernails, etc[.]) but not including 
        results which assess the biological effect of a substance or 
        agent or which assess an employee's use of alcohol or drugs;
          (iii) Material safety data sheets indicating that the 
        material may pose a hazard to human health; or
          (iv) In the absence of the above, a [chemical] inventory or 
        any other record which reveals where and when used and the 
        identity (e.g., chemical, common, or trade name) of a toxic 
        substance or harmful physical agent.

    (6)(i) Employee medical record means a record concerning the health 
status of an employee which is made or maintained by a physician, 
nurse, or other health care personnel or technician, including:

          (A) Medical and employment questionnaires or histories 
        (including job description and occupational exposures),
          (B) The results of medical examinations (pre-employment, pre-
        assignment, periodic, or episodic) and laboratory tests 
        (including chest and other X-ray examinations taken for the 
        purposes of establishing a base-line or detecting occupational 
        illness, and all biological monitoring not defined as an 
        ``employee exposure record''),
          (C) Medical opinions, diagnoses, progress notes, and 
        recommendations,
          (D) First aid records,
          (E) Descriptions of treatments and prescriptions, and
          (F) Employee medical complaints.

    (ii) ``Employee medical record'' does not include medical 
information in the form of:

          (A) Physical specimens (e.g., blood or urine samples) which 
        are routinely discarded as a part of normal medical practice; 
        or
          (B) Records concerning health insurance claims if maintained 
        separately from the employer's medical program and its records, 
        and not accessible to the employer by employee name or other 
        direct personal identifier (e.g., [S]ocial [S]ecurity [N]umber, 
        payroll number, etc.); or
          (C) Records created solely in preparation for litigation 
        which are privileged from discovery under the applicable rules 
        of procedure or evidence; or
          (D) Records concerning voluntary employee assistance programs 
        (alcohol, drug abuse, or personal counseling programs) if 
        maintained separately from the employer's medical program and 
        its records.

    (7) Employer means a current employer, a former employer, or a 
successor employer.
    (8) Exposure or exposed means that an employee is subjected to a 
toxic substance or harmful physical agent in the course of employment 
through any route of entry (inhalation, ingestion, skin contact or 
absorption, etc.), and includes past exposure and potential (e.g., 
accidental or possible) exposure, but does not include situations where 
the employer can demonstrate that the toxic substance or harmful 
physical agent is not used, handled, stored, generated, or present in 
the workplace in any manner different from typical non-occupational 
situations.
    (9) Health Professional means a physician, occupational health 
nurse, industrial hygienist, toxicologist, or epidemiologist, providing 
medical or other occupational health services to exposed employees.
    (10) Record means any item, collection, or grouping of information 
regardless of the form or process by which it is maintained (e.g., 
paper document, microfiche, microfilm, X-ray film, or automated data 
processing).
    (11) Specific chemical identity means the chemical name, Chemical 
Abstracts Service (CAS) Registry Number, or any other information that 
reveals the precise chemical designation of the substance.
    (12)(i) Specific written consent means a written authorization 
containing the following:

          (A) The name and signature of the employee authorizing the 
        release of medical information,
          (B) The date of the written authorization,
          (C) The name of the individual or organization that is 
        authorized to release the medical information,
          (D) The name of the designated representative (individual or 
        organization) that is authorized to receive the released 
        information,
          (E) A general description of the medical information that is 
        authorized to be released,
          (F) A general description of the purpose for the release of 
        the medical information, and
          (G) A date or condition upon which the written authorization 
        will expire (if less than one year).

    (ii) A written authorization does not operate to authorize the 
release of medical information not in existence on the date of written 
authorization, unless the release of future information is expressly 
authorized, and does not operate for more than one year from the date 
of written authorization.
    (iii) A written authorization may be revoked in writing 
prospectively at any time.
    (13) Toxic substance or harmful physical agent means any chemical 
substance, biological agent (bacteria, virus, fungus, etc.), or 
physical stress (noise, heat, cold, vibration, repetitive motion, 
ionizing and non-ionizing radiation, hypo- or hyperbaric pressure, 
etc.) which:

          (i) Is listed in the latest printed edition of the National 
        Institute for Occupational Safety and Health (NIOSH) Registry 
        of Toxic Effects of Chemical Substances (RTECS), which is 
        incorporated by reference as specified in  1910.6; or
          (ii) Has yielded positive evidence of an acute or chronic 
        health hazard in testing conducted by, or known to, the 
        employer; or
          (iii) Is the subject of a material safety data sheet kept by 
        or known to the employer indicating that the material may pose 
        a hazard to human health.

    (14) Trade secret means any confidential formula, pattern, process, 
device, or information or compilation of information that is used in an 
employer's business and that gives the employer an opportunity to 
obtain an advantage over competitors who do not know or use it.
    (d) Preservation of records. (1) Unless a specific occupational 
safety and health standard provides a different period of time, each 
employer shall assure the preservation and retention of records as 
follows:

          (i) Employee medical records. The medical record for each 
        employee shall be preserved and maintained for at least the 
        duration of employment plus thirty (30) years, except that the 
        following types of records need not be retained for any 
        specified period:

                  (A) Health insurance claims records maintained 
                separately from the employer's medical program and its 
                records,
                  (B) First aid records (not including medical 
                histories) of one-time treatment and subsequent 
                observation of minor scratches, cuts, burns, splinters, 
                and the like which do not involve medical treatment, 
                loss of consciousness, restriction of work or motion, 
                or transfer to another job, if made on-site by a non-
                physician and if maintained separately from the 
                employer's medical program and its records, and
                  (C) The medical records of employees who have worked 
                for less than (1) year for the employer need not be 
                retained beyond the term of employment if they are 
                provided to the employee upon the termination of 
                employment.

          (ii) Employee exposure records. Each employee exposure record 
        shall be preserved and maintained for at least thirty (30) 
        years, except that:

                  (A) Background data to environmental (workplace) 
                monitoring or measuring, such as laboratory reports and 
                worksheets, need only be retained for one (1) year as 
                long as the sampling results, the collection 
                methodology (sampling plan), a description of the 
                analytical and mathematical methods used, and a summary 
                of other background data relevant to interpretation of 
                the results obtained, are retained for at least thirty 
                (30) years; and
                  (B) Material safety data sheets and paragraph 
                (c)(5)(iv) records concerning the identity of a 
                substance or agent need not be retained for any 
                specified period as long as some record of the identity 
                (chemical name if known) of the substance or agent, 
                where it was used, and when it was used is retained for 
                at least thirty (30) years; \1\ and
---------------------------------------------------------------------------
    \1\ Material safety data sheets must be kept for those chemicals 
currently in use that are effected by the Hazard Communication Standard 
in accordance with 29 CFR 1910.1200(g).
---------------------------------------------------------------------------
                  (C) Biological monitoring results designated as 
                exposure records by specific occupational safety and 
                health standards shall be preserved and maintained as 
                required by the specific standard.

          (iii) Analyses using exposure or medical records. Each 
        analysis using exposure or medial records shall be preserved 
        and maintained for at least thirty (30) years.

    (2) Nothing in this section is intended to mandate the form, 
manner, or process by which an employer preserves a record as long as 
the information contained in the record is preserved and retrievable, 
except that chest X-ray films shall be preserved in their original 
state.
    (e) Access to records--(1) General. (i) Whenever an employee or 
designated representative requests access to a record, the employer 
shall assure that access is provided in a reasonable time, place, and 
manner. If the employer cannot reasonably provide access to the record 
within fifteen (15) working days, the employer shall within the fifteen 
(15) working days apprise the employee or designated representative 
requesting the record of the reason for the delay and the earliest date 
when the record can be made available.
    (ii) The employer may require of the requester only such 
information as should be readily known to the requester and which may 
be necessary to locate or identify the records being requested (e.g.[,] 
dates and locations where the employee worked during the time period in 
question).
    (iii) Whenever an employee or designated representative requests a 
copy of a record, the employer shall assure that either:

          (A) A copy of the record is provided without cost to the 
        employee or representative,
          (B) The necessary mechanical copying facilities (e.g., 
        photocopying) are made available without cost to the employee 
        or representative for copying the record, or
          (C) The record is loaned to the employee or representative 
        for a reasonable time to enable a copy to be made.

    (iv) In the case of an original X-ray, the employer may restrict 
access to on-site examination or make other suitable arrangements for 
the temporary loan of the X-ray.
    (v) Whenever a record has been previously provided without cost to 
an employee or designated representative, the employer may charge 
reasonable, non-discriminatory administrative costs (i.e., search and 
copying expenses but not including overhead expenses) for a request by 
the employee or designated representative for additional copies of the 
record, except that

          (A) An employer shall not charge for an initial request for a 
        copy of new information that has been added to a record which 
        was previously provided; and
          (B) An employer shall not charge for an initial request by a 
        recognized or certified collective bargaining agent for a copy 
        of an employee exposure record or an analysis using exposure or 
        medical records.

    (vi) Nothing in this section is intended to preclude employees and 
collective bargaining agents from collectively bargaining to obtain 
access to information in addition to that available under this section.
    (2) Employee and designated representative access--(i) Employee 
exposure records. (A) Except as limited by paragraph (f) of this 
section, each employer shall, upon request, assure the access to each 
employee and designated representative to employee exposure records 
relevant to the employee. For the purpose of this section, an exposure 
record relevant to the employee consists of:

          (1) A record which measures or monitors the amount of a toxic 
        substance or harmful physical agent to which the employee is or 
        has been exposed;
          (2) In the absence of such directly relevant records, such 
        records of other employees with past or present job duties or 
        working conditions related to or similar to those of the 
        employee to the extent necessary to reasonably indicate the 
        amount and nature of the toxic substances or harmful physical 
        agents to which the employee is or has been subjected, and
          (3) Exposure records to the extent necessary to reasonably 
        indicate the amount and nature of the toxic substances or 
        harmful physical agents at workplaces or under working 
        conditions to which the employee is being assigned or 
        transferred.

    (B) Requests by designated representatives for unconsented access 
to employee exposure records shall be in writing and shall specify with 
reasonable particularity:

          (1) The records requested to be disclosed; and
          (2) The occupational health need for gaining access to these 
        records.

    (ii) Employee medical records. (A) Each employer shall, upon 
request, assure the access of each employee to employee medical records 
of which the employee is the subject, except as provided in paragraph 
(e)(2)(ii)(D) of this section.
    (B) Each employer shall, upon request, assure the access of each 
designated representative to the employee medical records of any 
employee who has given the designated representative specific written 
consent. [A]ppendix A to this section contains a sample form which may 
be used to establish specific written consent for access to employee 
medical records.
    (C) Whenever access to employee medical records is requested, a 
physician representing the employer may recommend that the employee or 
designated representative:

          (1) Consult with the physician for the purposes of reviewing 
        and discussing the records requested,
          (2) Accept a summary of material facts and opinions in lieu 
        of the records requested, or
          (3) Accept release of the requested records only to a 
        physician or other designated representative.

    (D) Whenever an employee requests access to his or her employee 
medical records, and a physician representing the employer believes 
that direct employee access to information contained in the records 
regarding a specific diagnosis of a terminal illness or a psychiatric 
condition could be detrimental to the employee's health, the employer 
may inform the employee that access will only be provided to a 
designated representative of the employee having specific written 
consent, and deny the employee's request for direct access to this 
information only. Where a designated representative with specific 
written consent requests access to information so withheld, the 
employer shall assure the access of the designated representative to 
this information, even when it is known that the designated 
representative will give the information to the employee.
    (E) A physician, nurse, or other responsible health care personnel 
maintaining medical records may delete from requested medical records 
the identity of a family member, personal friend, or fellow employee 
who has provided confidential information concerning an employee's 
health status.
    (iii) Analyses using exposure or medical records. (A) Each employee 
shall, upon request, assure the access of each employee and designated 
representative to each analysis using exposure or medical records 
concerning the employee's working conditions or workplace.
    (B) Whenever access is requested to an analysis which reports the 
contents of employee medical records by either direct identifier (name, 
address, [S]ocial [S]ecurity [N]umber, payroll number, etc.) or by 
information which could reasonably be used under the circumstances 
indirectly to identify specific employees (exact age, height, weight, 
race, sex, date of initial employment, job title, etc.), the employer 
shall assure that personal identifiers are removed before access is 
provided. If the employer can demonstrate that removal of personal 
identifiers from an analysis is not feasible, access to the personally 
identifiable portions of the analysis need not be provided.
    (3) OSHA access. (i) Each employer shall, upon request, and without 
derogation of any rights under the Constitution or the Occupational 
Safety and Health Act of 1970, 29 U.S.C. 651 et seq., that the employer 
chooses to exercise, assure the prompt access of representatives of the 
Assistant Secretary of Labor for Occupational Safety and Health to 
employee exposure and medical records and to analyses using exposure or 
medical records. Rules of agency practice and procedure governing OSHA 
access to employee medical records are contained in 29 CFR 1913.10.
    (ii) Whenever OSHA seeks access to personally identifiable employee 
medical information by presenting to the employer a written access 
order pursuant to 29 CFR 1913.10(d), the employer shall prominently 
post a copy of the written access order and its accompanying cover 
letter for at least fifteen (15) working days.
    (f) Trade secrets. (1) Except as provided in paragraph (f)(2) of 
this section, nothing in this section precludes an employer from 
deleting from records requested by a health professional, employee, or 
designated representative any trade secret data which discloses 
manufacturing processes, or discloses the percentage of a chemical 
substance in mixture, as long as the health professional, employee, or 
designated representative is notified that information has been 
deleted. Whenever deletion of trade secret information substantially 
impairs evaluation of the place where or the time when exposure to a 
toxic substance or harmful physical agent occurred, the employer shall 
provide alternative information which is sufficient to permit the 
requesting party to identify where and when exposure occurred.
    (2) The employer may withhold the specific chemical identity, 
including the chemical name and other specific identification of a 
toxic substance from a disclosable record provided that:

          (i) The claim that the information withheld is a trade secret 
        can be supported;
          (ii) All other available information on the properties and 
        effects of the toxic substance is disclosed;
          (iii) The employer informs the requesting party that the 
        specific chemical identity is being withheld as a trade secret; 
        and
          (iv) The specific chemical identity is made available to 
        health professionals, employees and designated representatives 
        in accordance with the specific applicable provisions of this 
        paragraph.

    (3) Where a treating physician or nurse determines that a medical 
emergency exists and the specific chemical identity of a toxic 
substance is necessary for emergency or first-aid treatment, the 
employer shall immediately disclose the specific chemical identity of a 
trade secret chemical to the treating physician or nurse, regardless of 
the existence of a written statement of need or a confidentiality 
agreement. The employer may require a written statement of need and 
confidentiality agreement, in accordance with the provisions of 
paragraphs (f)(4) and (f)(5), as soon as circumstances permit.
    (4) In non-emergency situations, an employer shall, upon request, 
disclose a specific chemical identity, otherwise permitted to be 
withheld under paragraph (f)(2) of this section, to a health 
professional, employee, or designated representative if:

          (i) The request is in writing;
          (ii) The request describes with reasonable detail one or more 
        of the following occupational health needs for the information:

                  (A) To assess the hazards of the chemicals to which 
                employees will be exposed;
                  (B) To conduct or assess sampling of the workplace 
                atmosphere to determine employee exposure levels;
                  (C) To conduct pre-assignment or periodic medical 
                surveillance of exposed employees;
                  (D) To provide medical treatment to exposed 
                employees;
                  (E) To select or assess appropriate personal 
                protective equipment for exposed employees;
                  (F) To design or assess engineering controls or other 
                protective measures for exposed employees; and
                  (G) To conduct studies to determine the health 
                effects of exposure.

          (iii) The request explains in detail why the disclosure of 
        the specific chemical identity is essential and that, in lieu 
        thereof, the disclosure of the following information would not 
        enable the health professional, employee or designated 
        representative to provide the occupational health services 
        described in paragraph (f)(4)(ii) of this section:

                  (A) The properties and effects of the chemical;
                  (B) Measures for controlling workers' exposure to the 
                chemical;
                  (C) Methods of monitoring and analyzing worker 
                exposure to the chemical; and,
                  (D) Methods of diagnosing and treating harmful 
                exposures to the chemical;

          (iv) The request includes a description of the procedures to 
        be used to maintain the confidentiality of the disclosed 
        information; and,
          (v) The health professional, employee, or designated 
        representative and the employer or contractor of the services 
        of the health professional or designated representative agree 
        in a written confidentiality agreement that the health 
        professional, employee or designated representative will not 
        use the trade secret information for any purpose other than the 
        health need(s) asserted and agree not to release the 
        information under any circumstances other than to OSHA, as 
        provided in paragraph (f)(7) of this section, except as 
        authorized by the terms of the agreement or by the employer.

    (5) The confidentiality agreement authorized by paragraph 
(f)(4)(iv) of this section:

          (i) May restrict the use of the information to the health 
        purposes indicated in the written statement of need;
          (ii) May provide for appropriate legal remedies in the event 
        of a breach of the agreement, including stipulation of a 
        reasonable pre-estimate of likely damages; and,
          (iii) May not include requirements for the posting of a 
        penalty bond.

    (6) Nothing in this section is meant to preclude the parties from 
pursuing non-contractual remedies to the extent permitted by law.
    (7) If the health professional, employee or designated 
representative receiving the trade secret information decides that 
there is a need to disclose it to OSHA, the employer who provided the 
information shall be informed by the health professional prior to, or 
at the same time as, such disclosure.
    (8) If the employer denies a written request for disclosure of a 
specific chemical identity, the denial must:

          (i) Be provided to the health professional, employee or 
        designated representative within thirty days of the request;
          (ii) Be in writing;
          (iii) Include evidence to support the claim that the specific 
        chemical identity is a trade secret;
          (iv) State the specific reasons why the request is being 
        denied; and,
          (v) Explain in detail how alternative information may satisfy 
        the specific medical or occupational health need without 
        revealing the specific chemical identity.

    (9) The health professional, employee, or designated representative 
whose request for information is denied under paragraph (f)(4) of this 
section may refer the request and the written denial of the request to 
OSHA for consideration.
    (10) When a heath professional employee, or designated 
representative refers a denial to OSHA under paragraph (f)(9) of this 
section, OSHA shall consider the evidence to determine if:

          (i) The employer has supported the claim that the specific 
        chemical identity is a trade secret;
          (ii) The health professional employee, or designated 
        representative has supported the claim that there is a medical 
        or occupational health need for the information; and
          (iii) The health professional, employee or designated 
        representative has demonstrated adequate means to protect the 
        confidentiality.

    (11)(i) If OSHA determines that the specific chemical identity 
requested under paragraph (f)(4) of this section is not a bona fide 
trade secret, or that it is a trade secret but the requesting health 
professional, employee or designated representatives has a legitimate 
medical or occupational health need for the information, has executed a 
written confidentiality agreement, and has shown adequate means for 
complying with the terms of such agreement, the employer will be 
subject to citation by OSHA.
    (ii) If an employer demonstrates to OSHA that the execution of a 
confidentiality agreement would not provide sufficient protection 
against the potential harm from the unauthorized disclosure of a trade 
secret specific chemical identity, the Assistant Secretary may issue 
such orders or impose such additional limitations or conditions upon 
the disclosure of the requested chemical information as may be 
appropriate to assure that the occupational health needs are met 
without an undue risk of harm to the employer.
    (12) Notwithstanding the existence of a trade secret claim, an 
employer shall, upon request, disclose to the Assistant Secretary any 
information which this section requires the employer to make available. 
Where there is a trade secret claim, such claim shall be made no later 
than at the time the information is provided to the Assistant Secretary 
so that suitable determinations of trade secret status can be made and 
the necessary protections can be implemented.
    (13) Nothing in this paragraph shall be construed as requiring the 
disclosure under any circumstances of process or percentage of mixture 
information which is trade secret.
    (g) Employee information. (1) Upon an employee's first entering 
into employment, and at least annually thereafter, each employer shall 
inform current employees covered by this section of the following:

          (i) The existence, location, and availability of any records 
        covered by this section;
          (ii) The person responsible for maintaining and providing 
        access to records; and
          (iii) Each employee's rights of access to these records.

    (2) Each employer shall keep a copy of this section and its 
appendices, and make copies readily available, upon request, to 
employees. The employer shall also distribute to current employees any 
informational materials concerning this section which are made 
available to the employer by the Assistant Secretary of Labor for 
Occupational Safety and Health.
    (h) Transfer of records. (1) Whenever an employer is ceasing to do 
business, the employer shall transfer all records subject to this 
section to the successor employer. The successor employer shall receive 
and maintain these records.
    (2) Whenever an employer is ceasing to do business and there is no 
successor employer to receive and maintain the records subject to this 
standard, the employer shall notify affected current employees of their 
rights of access to records at least three (3) months prior to the 
cessation of the employer's business.
    (i) Appendices. The information contained in appendices A and B to 
this section is not intended, by itself, to create any additional 
obligations not otherwise imposed by this section nor detract from any 
existing obligation.
Appendix A to  1910.1020--Sample Authorization Letter for the Release 
        of Employee Medical Record Information to a Designated 
        Representative (Non-Mandatory)
    I, ____ (full name of worker/patient), hereby authorize ____ 
(individual or organization holding the medical records) to release to 
____ (individual or organization authorized to receive the medical 
information), the following medical information from my personal 
medical records:

------------------------------------------------------------------------
 
-------------------------------------------------------------------------
 
------------------------------------------------------------------------

(Describe generally the information desired to be released)
    I give my permission for this medical information to be used for 
the following purpose:

------------------------------------------------------------------------
 
-------------------------------------------------------------------------
 
------------------------------------------------------------------------

but I do not give permission for any other use or re-disclosure of this 
information.
    Note: Several extra lines are provided below so that you can place 
additional restrictions on this authorization letter if you want to. 
You may, however, leave these lines blank. On the other hand, you may 
want to (1) specify a particular expiration date for this letter (if 
less than one year); (2) describe medical information to be created in 
the future that you intend to be covered by this authorization letter; 
or (3) describe portions of the medical information in your records 
which you do not intend to be released as a result of this letter.)

------------------------------------------------------------------------
 
-------------------------------------------------------------------------
 
------------------------------------------------------------------------
 
------------------------------------------------------------------------
 
------------------------------------------------------------------------

Full name of Employee or Legal Representative

------------------------------------------------------------------------
 
-------------------------------------------------------------------------
 
------------------------------------------------------------------------

Signature of Employee or Legal Representative

------------------------------------------------------------------------
 
-------------------------------------------------------------------------
 
------------------------------------------------------------------------

Date of Signature
Appendix B to  1910.1020--Availability of NIOSH Registry of Toxic 
        Effects of Chemical Substances (RTECS) (Non-Mandatory)
    The final regulation, 29 CFR 1910.20, applies to all employee 
exposure and medical records, and analyses thereof, of employees 
exposed to toxic substances or harmful physical agents (paragraph 
(b)(2)). The term toxic substance or harmful physical agent is defined 
by paragraph (c)(13) to encompass chemical substances, biological 
agents, and physical stresses for which there is evidence of harmful 
health effects. The regulation uses the latest printed edition of the 
National Institute for Occupational Safety and Health (NIOSH) Registry 
of Toxic Effects of Chemical Substances (RTECS) as one of the chief 
sources of information as to whether evidence of harmful health effects 
exists. If a substance is listed in the latest printed RTECS, the 
regulation applies to exposure and medical records (and analyses of 
these records) relevant to employees exposed to the substance.
    It is appropriate to note that the final regulation does not 
require that employers purchase a copy of RTECS, and many employers 
need not consult RTECS to ascertain whether their employee exposure or 
medical records are subject to the rule. Employers who do not currently 
have the latest printed edition of the NIOSH RTECS, however, may desire 
to obtain a copy. The RTECS is issued in an annual printed edition as 
mandated by section 20(a)(6) of the Occupational Safety and Health Act 
(29 U.S.C. 669(a)(6)).
    The Introduction to the 1980 printed edition describes the RTECS as 
follows:

          ``The 1980 edition of the Registry of Toxic Effects of 
        Chemical Substances, formerly known as the Toxic Substances 
        list, is the ninth revision prepared in compliance with the 
        requirements of Section 20(a)(6) of the Occupational Safety and 
        Health Act of 1970 (Public Law 91-596). The original list was 
        completed on June 28, 1971, and has been updated annually in 
        book format. Beginning in October 1977, quarterly revisions 
        have been provided in microfiche. This edition of the Registry 
        contains 168,096 listings of chemical substances: 45,156 are 
        names of different chemicals with their associated toxicity 
        data and 122,940 are synonyms. This edition includes 
        approximately 5,900 new chemical compounds that did not appear 
        in the 1979 Registry. (p. xi)
          ``The Registry's purposes are many, and it serves a variety 
        of users. It is a single source document for basic toxicity 
        information and for other data, such as chemical identifiers ad 
        information necessary for the preparation of safety directives 
        and hazard evaluations for chemical substances. The various 
        types of toxic effects linked to literature citations provide 
        researchers and occupational health scientists with an 
        introduction to the toxicological literature, making their own 
        review of the toxic hazards of a given substance easier. By 
        presenting data on the lowest reported doses that produce 
        effects by several routes of entry in various species, the 
        Registry furnishes valuable information to those responsible 
        for preparing safety data sheets for chemical substances in the 
        workplace. Chemical and production engineers can use the 
        Registry to identify the hazards which may be associated with 
        chemical intermediates in the development of final products, 
        and thus can more readily select substitutes or alternative 
        processes which may be less hazardous. Some organizations, 
        including health agencies and chemical companies, have included 
        the NIOSH Registry accession numbers with the listing of 
        chemicals in their files to reference toxicity information 
        associated with those chemicals. By including foreign language 
        chemical names, a start has been made toward providing rapid 
        identification of substances produced in other countries. (p. 
        xi)
          ``In this edition of the Registry, the editors intend to 
        identify `all known toxic substances' which may exist in the 
        environment and to provide pertinent data on the toxic effects 
        from known doses entering an organism by any route described. 
        (p xi)
          ``It must be reemphasized that the entry of a substance in 
        the Registry does not automatically mean that it must be 
        avoided. A listing does mean, however, that the substance has 
        the documented potential of being harmful if misused, and care 
        must be exercised to prevent tragic consequences. Thus, the 
        Registry lists many substances that are common in everyday life 
        and are in nearly every household in the United States. One can 
        name a variety of such dangerous substances: prescription and 
        non-prescription drugs; food additives; pesticide concentrates, 
        sprays, and dusts; fungicides; herbicides; paints; glazes, 
        dyes; bleaches and other household cleaning agents; alkalies; 
        and various solvents and diluents. The list is extensive 
        because chemicals have become an integral part of our 
        existence.''

    The RTECS printed edition may be purchased from the Superintendent 
of Documents, U.S. Government Printing Office (GPO), Washington, D.C. 
20402 (202-783-3238).
    Some employers may desire to subscribe to the quarterly update to 
the RTECS which is published in a microfiche edition. An annual 
subscription to the quarterly microfiche may be purchased from the GPO 
(Order the ``Microfiche Edition, Registry of Toxic Effects of Chemical 
Substances''). Both the printed edition and the microfiche edition of 
RTECS are available for review at many university and public libraries 
throughout the country. The latest RTECS editions may also be examined 
at the OSHA Technical Data Center, Room N2439--Rear, United States 
Department of Labor, 200 Constitution Avenue, NW., Washington, DC 20210 
(202-523-9700), or at any OSHA Regional or Area Office (See, major city 
telephone directories under United States Government--Labor 
Department).

          [53 FR 38163, Sept. 29, 1988; 53 FR 49981, Dec. 13, 1988, as 
        amended at 54 FR 24333, June 7, 1989; 55 FR 26431, June 28, 
        1990; 61 FR 9235, Mar. 7, 1996. Redesignated at 61 FR 31430, 
        June 20, 1996, as amended at 71 FR 16673, Apr. 3, 2006; 76 FR 
        33608, June 8, 2011]

          [Accessed September 8, 2016]
                            [attachment 17]
    [https://www.epa.gov/sap/meeting-materials-december-4-6-2013-
scientific-advisory-panel]
Meeting Materials for the December 4-6, 2013 Scientific Advisory Panel
Topic: Scientific Uncertainties Associated with Corn Rootworm 
        Resistance Monitoring for Bt Corn Plant Incorporated 
        Protectants (PIPs)
    Available meeting materials are listed below. Visit docket EPA-HQ-
OPP-2013-0490 for additional background materials (http://
www.regulations.gov/#%21docketDetail;D=EPA-HQ-OPP-2013-0490).
    You will need Adobe Reader to view some of the files on this page. 
See EPA's About PDF page (https://www.epa.gov/home/pdf-files) to learn 
more.

   Agenda (December 4-6, 2013) (PDF) (https://www.epa.gov/
        sites/production/files/2015-06/documents/120413agenda.pdf) (6 
        pp, 41 K)

   Panel Members (December 4-6, 2013) (PDF) (https://
        www.epa.gov/sites/production/files/2015-06/documents/
        120413panel.pdf) (2 pp, 32 K)

   Meeting Minutes (December 4-6, 2013) (PDF) (https://
        www.epa.gov/sites/production/files/2015-06/documents/
        120413minutes.pdf) (72 pp, 488 K)

    Contact Us (https://www.epa.gov/sap/forms/contact-us-about-fifra-
scientific-advisory-panel) to ask a question, provide feedback, or 
report a problem.

          [Accessed September 8, 2016]
                            [attachment 18]
Records Management Policy

 
 
 
EPA Classification No.: CIO 2155.3   CIO Approval Date: 02/10/2015
CIO Transmittal No.: 15-005          Review Date: 02/10/2018
 

Issued by the EPA Chief Information Officer, Pursuant to Delegation 1-
        19, dated 07/07/2005
1. Purpose
   To advance a focus on overall records management 
        responsibilities under the Federal Records Act (FRA), as 
        amended, and other applicable authorities.

   To confirm and align principles, responsibilities and 
        requirements for managing the Environmental Protection Agency's 
        (EPA's) records to ensure that the Agency is in compliance with 
        Federal laws and regulations; EPA policies; and best practices 
        for managing records.

   To provide the framework for specific guidance and detailed 
        operating procedures governing records management.
2. Scope and Applicability
    This policy addresses all records made or received by EPA employees 
under Federal law or in connection with the transaction of public 
business, and preserved or appropriate for preservation as evidence of 
EPA functions, organization and activities or because of the value of 
the information they contain. This policy applies to all EPA 
headquarters, regional, laboratory and other organizations.
3. Audience
    The audience for this policy includes all EPA organizations, 
officials, and employees; those who oversee contractors and grantees; 
and non-EPA employees who manage Agency records, as appropriate.
4. Background
    The FRA, as amended, requires all Federal agencies to make and 
preserve records containing adequate and proper documentation of their 
organization, function, policies, decisions, procedures and essential 
transactions. These records are public property and must be managed 
according to applicable laws and regulations.
    The FRA also requires agencies to establish a records management 
program, defined as a planned, coordinated set of policies, procedures, 
and activities needed to manage their recorded information. Major 
elements include periodically issuing up-to-date records management 
directives, properly training those responsible for implementation and 
carefully evaluating the results to ensure adequacy, effectiveness and 
efficiency.
    Records serve a number of purposes including: planning for 
administrative and program needs, providing evidence of EPA activities, 
protecting legal and financial rights, enabling oversight by Congress 
and other authorized agencies, documenting the Agency's history, and 
continuing key functions and activities in the event of an emergency or 
disaster. Records capture the Agency's institutional memory and 
preserve the historical record; they are of critical importance in 
ensuring that the organization continues to function effectively and 
efficiently. In conformance with the Presidential Memorandum, Managing 
Government Records, November 28, 2011, the Agency must ``meet the 
executive branch-wide effort to reform records management policies and 
practices. [The results will improve] performance and promote openness 
and accountability by better documenting agency actions and 
decisions.''
5. Authority
    a. 44 U.S.C. Chapter 31--Records Management by Federal Agencies 
(Federal Records Act) [http://www.archives.gov/about/laws/fed-
agencies.html]
    b. 44 U.S.C. Chapter 33--Disposal of Records [http://
www.archives.gov/about/laws/disposal-of-records.html]
    c. 44 U.S.C. Chapter 35--Coordination of Federal Information Policy 
(Paperwork Reduction Act of 1980, as amended, Paperwork Reduction 
Reauthorization Act of 1995, and Government Paperwork Elimination Act) 
[http://www.archives.gov/about/laws/fed-information-policy.html]
    d. 36 CFR Chapter XII, Subchapter B--Records Management [http://
www.archives.gov/about/regulations/regulations.html]
    e. OMB Circular A-123--Management's Responsibility for Internal 
Control 
[http://www.whitehouse.gov/omb/circulars/a123/a123_rev.html]
    f. OMB Circular A-130--Management of Federal Information Resources 
[http://www.whitehouse.gov/omb/circulars/a130/a130trans4.html]
    g. U.S. EPA, National Security Emergency Preparedness Policy (Order 
2040.1A1) [http://intranet.epa.gov/ohr/rmpolicy/ads/orders/2040-
1a1.pdf]
    h. U.S. EPA, Uniform Continuity of Operations (COOP) Plan Policy 
(Order 2030.1a) [http://intranet.epa.gov/ohr/rmpolicy/ads/orders/2030-
1a.pdf]
    i. Federal Emergency Management Agency (FEMA) Federal Preparedness 
Circular 65--Federal Executive Branch Continuity of Operations (COOP) 
[http://www.fema.gov/pdf/library/fpc65_0604.pdf]
    j. Presidential Memorandum, Managing Government Records, November 
28, 2011 [http://www.whitehouse.gov/the-press-office/2011/11/28/
presidential-memorandum-managing-government-records]
    k. U.S. Environmental Protection Agency, Report on Managing 
Government Records, March 27, 2012. [http://intranet.epa.gov/records--
click on ``EPA's Response to Presidential Memo'' under ``Features'']
    l. Memorandum for the Heads of Executive Departments and Agencies 
and Independent Agencies, from The Office of Management and Budget and 
the National Archives and Records Administration, Managing Government 
Records Directive, August 24, 2012 [http://www.whitehouse.gov/sites/
default/files/omb/memoranda/2012/m-12-18.pdf]
    m. The Presidential and Federal Records Act Amendments H.R. 1233, 
signed by President Obama, November 26, 2014.
6. Policy
a. EPA's Responsibility and Commitment
    As a regulatory agency charged with protecting human health and the 
environment, the EPA is committed to managing the Agency's records 
properly to comply with legal requirements and to support the Agency's 
mission. Records identification, management and access are essential in 
allowing the Agency to meet its mission. The accuracy and consistency 
of how records are identified, captured, stored and retrieved provide 
the cornerstone to the effective functioning and transparent operation 
of the Agency. EPA is required to preserve Agency records in accordance 
with applicable statutory and regulatory requirements and to facilitate 
access to information by EPA staff, partners, stakeholders and the 
public, as appropriate.
    The Records Management Policy establishes specific requirements to 
effectively and efficiently identify, manage, search, retrieve and 
provide access to records throughout their lifecycle.
b. Creating and Receiving Records
    According to the FRA, every Federal agency is required to ``make 
and preserve records containing adequate and proper documentation of 
the organization, functions, policies, decisions, procedures, and 
essential transactions of the agency and designed to furnish the 
information necessary to protect the legal and financial rights of the 
Government and of persons directly affected by the agency's 
activities.'' Records contain the information that documents how EPA 
carries out its mission. The Agency's past and current work generates 
records. Records typically include information which is:

   Created in the course of doing Agency business;

   Received for action;

   Needed to document EPA activities and decisions;

   Required to support EPA's financial and other obligations 
        and legal claims; or

   Communicated to assert EPA requirements or guidance.

    All EPA staff generate and receive records and are legally required 
to maintain them.
    Records document the Agency's business and can be found in all 
media such as paper, e-mail, instant messaging (IM), text messages, 
telephone messages, voice mail messages, presentations, websites, 
social media (e.g., Facebook, Twitter, etc.), word processing 
documents, spreadsheets, and information systems. If electronic records 
are created using any of these media, they need to be transferred to an 
electronic records management system.
    Not all information created or received constitutes a record. Non-
records include reference material, supplementary or convenience 
copies, a draft document or working paper with no substantive comments, 
and personal information which is unrelated to EPA business.
    Some records are transitory in nature, which means they are of 
short-term (180 days or less) interest, including in electronic form, 
and have minimal or no documentary or evidential value.
    Official Agency business should first and foremost be done on 
official EPA information systems. The FRA now prohibits the creation or 
sending of a Federal record using a non-EPA electronic messaging 
account unless the individual creating or sending the record either: 
(1) copies their EPA e-mail account at the time of initial creation or 
transmission of the record, or (2) forwards a complete copy of the 
record to their EPA e-mail account within 20 days of the original 
creation or transmission of the record. These FRA requirements are 
designed to ensure that any use of a non-EPA information system does 
not affect the preservation of Federal records for FRA purposes, or the 
ability to identify and process those records if requested under the 
Freedom of Information Act (FOIA), Privacy Act or for other official 
business (e.g., litigation, congressional oversight requests, etc.). 
EPA strongly discourages the use of personal e-mail or other personal 
electronic messaging systems, including text messaging on a personal 
mobile device, for sending or receiving Agency records, but to the 
extent such use occurs, the individual creating or sending the record 
from a non-EPA electronic messaging system must copy their EPA e-mail 
account at the time of transmission or forward that record to their EPA 
e-mail account within 20 days of creation or sending.
    Additionally, EPA discourages the use of text messaging on a mobile 
device for sending or receiving substantive (or non-transitory) Agency 
records. However, EPA recognizes that some Agency staff perform time-
sensitive work that may, at times, require the creation of substantive 
(or non-transitory) records in the form of text messages for emergency 
or environmental notification purposes. In those limited instances, 
staff must continue to save and manage any text message records related 
to their work, as discussed below.
c. Managing Records
    Records are managed for the benefit of EPA and its staff, partners, 
stakeholders and the public. EPA is committed to maintaining and 
converting its records to electronic formats, where practical, to 
facilitate moving away from paper toward more effective and efficient 
electronic solutions. Non-transitory records should be stored in 
approved records management systems with records management 
capabilities or registered information management systems associated 
with an approved records schedule.
    It is important not to use non-EPA systems to conduct Agency 
business, since such use could potentially lead to the mismanagement of 
Agency records and/or the unauthorized disclosure of Agency 
information. In the rare situation when a non-EPA messaging system must 
be used and a Federal record is created or received on a non-EPA 
messaging system (such as a personal e-mail account or personal mobile 
device), pursuant to the FRA, staff must either: (1) copy their EPA e-
mail account at the time of initial creation or transmission of the 
record, or (2) forward a complete copy of the record to their EPA e-
mail account within 20 days of the original creation or transmission of 
the record. Once the message is sent or forwarded to the EPA messaging 
system, you must save the record in an approved EPA electronic records 
management system. Once the electronic files have been captured in an 
approved EPA records management system, they should be removed from 
non-EPA messaging systems, unless there is a specific obligation (such 
as a litigation hold) to maintain the files on all systems on which 
they appear.
    Additionally, e-mails forwarding a news article or Web links from a 
personal e-mail account to EPA's system and e-mails from EPA forwarding 
a document to a personal e-mail account both create a copy of the e-
mail in EPA's e-mail system. Users can then properly preserve the copy 
of the e-mail record in a record-keeping system to meet their 
preservation requirements, if needed.
    Similarly, users of text messaging, instant messaging or other 
transient messaging technologies on EPA information systems are 
responsible for ensuring that messages that result in the creation of a 
substantive (or non-transitory) Federal records are saved for FRA 
purposes and placed in a record-keeping system. For example, if a text 
message on an EPA mobile device is received or sent that qualifies as a 
substantive (or non-transitory) Federal record, it must be saved into 
an approved record-keeping system. In order to comply with this 
requirement, you can forward the text message into the EPA system, so 
that you may then save it in an approved record-keeping system such as 
EZ Email Records. When forwarding the text message from the mobile 
device to the EPA e-mail system, be sure to include the time, date, 
subject, and sender/recipient of the message whenever possible. 
Guidance on how to e-mail a text message from a mobile device to 
yourself is available at http://intranet.epa.gov/mobiledevices/pdf/
Instructions-Saving-Text-Messages.pdf.
    Instant messages (such as Lync chats) that constitute substantive 
(or non-transitory) records should also be saved into an approved 
Agency record-keeping system. Guidance on how to save instant messages 
(Lync chats) is available at http://intranet.epa.gov/ecms/guides/
im.htm.
d. Access
    EPA records must be maintained in an appropriate manner, captured 
and organized to ensure timely search and retrieval for internal Agency 
use as well as for responses to outside inquiries. Sensitive records 
(e.g., sensitive personally identifiable information (SPII), and other 
Controlled Unclassified Information (CUI)) must be maintained with 
restricted access in accordance with statutory and regulatory 
requirements.
e. Implementation
    Each office within EPA must establish and maintain a records 
management program with the following minimum requirements.

  1.  Create, receive and maintain records providing adequate and 
            proper documentation and evidence of EPA's activities.

  2.  Manage records in any format (e.g., paper, e-mails, IMs, text 
            messages, electronic documents, spreadsheets, 
            presentations, images, maps, videos, blogs and other social 
            media tools that generate communications) in accordance 
            with applicable statutes, regulations, and EPA policy and 
            guidance, including records schedules.

  3.  Maintain electronic records (e.g., e-mails, IMs, text messages, 
            electronic documents, spreadsheets, presentations, images, 
            maps, videos, blogs and other social media tools that 
            generate communications) electronically in an approved 
            electronic records system. Non-e-mail electronic records, 
            including electronic records that cannot be forwarded to 
            and managed as an e-mail record, should be saved in their 
            native format in an organized way on an EPA network drive 
            until an approved electronic records management system is 
            available for desktop records.

  4.  Transfer or migrate records in paper and legacy electronic 
            systems to approved or registered information management 
            systems which are associated with a records schedule for 
            manual management of disposition where practicable and when 
            available. The Registry of Environmental Applications and 
            Databases (READ) often captures information on systems 
            which have a records schedule and require manual 
            disposition.

  5.  Ensure that non-electronic records are managed appropriately in 
            paper-based official record-keeping systems which 
            facilitate their preservation, retrieval, use and 
            disposition, if they are not appropriate for scanning (or 
            digitization).

  6.  Maintain records so they can be accessed by staff with a need to 
            know the information for appropriate business reasons and 
            maintained for the required retention period.

  7.  Secure records to protect the legal and financial rights of the 
            government and persons affected by government activities.

  8.  Implement a plan to protect essential (vital) records and assess 
            damage to and recover any records affected by an emergency 
            or disaster (e.g., financial, legal and emergency operating 
            records).

  9.  Ensure that instructions for the management and disposition of 
            records as specified in the approved records schedules are 
            followed.
7. Related Documents
    a. EPA Records Management Manual [http://www.epa.gov/records/
policy/manual/index.htm]
    b. Additional documents, including forms, guidance and other 
relevant information are maintained on EPA's records management 
website. [http://www.epa.gov/records/]
    c. International Standard ISO 15489-1:2001--Information and 
documentation--Records management--Part 1: General. [http://
www.iso.org/iso/catalogue--detail?csnumber=31908]
    d. International Standard ISO/TR 15489-2:2001--Information and 
documentation--Records management--Part 2: Guidelines. [http://
www.iso.org/iso/catalogue_detail.htm?csnumber=35845]
    e. NARA Bulletin 2013-03: Guidance for agency employees on the 
management of Federal records, including e-mail accounts, and the 
protection of Federal records from unauthorized removal. [http://
www.archives.gov/records-mgmt/bulletins/2013/2013-03.html]
    f. NARA Bulletin 2013-02: Guidance on a new approach to managing e-
mail records. [http://www.archives.gov/records-mgmt/bulletins/2013/
2013-02.html]
    g. NARA Bulletin 2012-02: Guidance on managing content on shared 
drives, December 6, 2011. [http://www.archives.gov/records-mgmt/
bulletins/2012/2012-02.html]
    h. EPA Privacy Policy, CIO 2151.0 [http://www.epa.gov/privacy1/
policy/2151/index.htm]
    i. EPA Guidance, Frequent Questions about E-Mail and Records 
[http://www.epa.gov/records/faqs/email.htm]
    j. EPA Guidance, Managing Social Media Records--DRAFT--12/05/12
8. Roles and Responsibilities
    a. The EPA's Administrator is responsible for creating and 
preserving records that adequately and properly document the 
organization, functions, policies, decisions, procedures and essential 
transactions of EPA. This responsibility is delegated to the Assistant 
Administrator (AA) for the Office of Environmental Information (OEI) 
and Chief Information Officer (CIO). As mandated by the Presidential 
Memorandum of November 28, 2011, the Administrator is also responsible 
for designating a Senior Agency Official (SAO) at the Assistant 
Secretary level or its equivalent who has direct responsibility for 
ensuring that the Agency efficiently and appropriately complies with 
all applicable records management statutes, regulations, and NARA 
policy, and requirements of the OMB/NARA Directive of August 24, 2012--
Managing Government Records. The Administrator has designated the OEI 
AA/CIO as this SAO for records management.
    b. OEI is responsible for leadership, planning, overall policy, 
guidance and general oversight of records management in the Agency, and 
its incorporation into the broader information resources management 
framework. OEI is responsible for the following:

  1.  Incorporating records management requirements and policies into 
            the Agency's overall information resources management (IRM) 
            policy and planning.

  2.  Designating an Agency Records Officer responsible for:

     Leading and managing the Agency-wide national records 
            management program.

     Ensuring Agency senior officials are aware of their 
            programmatic and individual records management 
            responsibilities and requirements.

     Advising EPA on records management issues and developing 
            Agency-wide records management policies, procedures, 
            guidance, and training materials.

     Coordinating the approval of the Agency's records 
            schedules and the transfer of records to NARA.

     Coordinating records management issues with other Federal 
            agencies, including Federal oversight agencies such as the 
            Office of Management and Budget (OMB), NARA, and the 
            General Services Administration (GSA).

     Providing technical advice and training to all Agency 
            organizations on establishing and maintaining effective 
            records management programs.

     Evaluating record-keeping practices to determine the 
            effectiveness of the program.

     Obtaining NARA's Certificate in Federal Records 
            Management.

  3.  Promulgating and communicating Agency-wide policies and guidance 
            that reflect records management missions and goals and 
            incorporate Federal requirements.

  4.  Designating other records management staff as required by 
            regulations or as deemed necessary.

  5.  Assigning overall responsibility for the records management 
            aspects of centrally provided information technology 
            infrastructure, including local area network applications.

  6.  Ensuring senior Agency officials are aware of their records 
            management responsibilities.

  7.  Conducting periodic evaluations of records management programs 
            within the Agency as part of the Agency's IRM review and 
            oversight program.

    c. Assistant Administrators, Chief Financial Officer, General 
Counsel and Regional Counsel, Inspector General, Regional 
Administrators and Laboratory/Center/Office Directors are responsible 
for the following:

  1.  Being an advocate for records management in their organization.

  2.  Personally demonstrating the importance of records management and 
            ensuring their organization is aware of the importance of 
            and processes for managing records.

  3.  Demonstrating their commitment to the proper management of 
            records in their organization through appropriate means 
            (e.g., sending out messages, being present during days 
            devoted to records management, encouraging managers and 
            staff to take records training).

  4.  Designating a Records Liaison Officer (RLO) accountable to the 
            Information Management Official (IMO) or other official 
            designated to oversee the program. The IMO or other 
            official designated to oversee the program reports to the 
            Assistant Administrators, Chief Financial Officer, General 
            Counsel, Inspector General, Regional Administrators and 
            Laboratory/Center/Office Directors on a quarterly basis.

  5.  Ensuring the RLO has adequate skills, resources, time and 
            appropriate authority to perform the job.

  6.  Overseeing the implementation of a records management program 
            within their area of responsibility to accomplish the 
            objectives identified in Federal regulations and EPA 
            policies and procedures. Minimum program components include 
            responsibilities for:

     Identifying record-keeping requirements for major 
            programmatic and administrative records.

     Ensuring that records are identified, proper records 
            schedules are assigned, and the records are properly 
            stored.

     Developing file plans and indexing approaches where 
            appropriate to simplify the use of, access to, and 
            integration of information within the organization.

     Drafting and updating records schedules for records 
            created and maintained by the organization.

     Implementing approved records schedules to ensure records 
            are not destroyed without proper authorization.

     Reviewing file plans and procedures at least every three 
            years to ensure they are current and updating them as 
            necessary.

     Assisting in planning and implementing information 
            management technology and reviewing the purchase of records 
            management equipment and services to ensure they conform to 
            Federal statutory and regulatory requirements.

     Implementing an essential (vital) records plan to ensure 
            the continuation of key functions and activities in the 
            event of an emergency or disaster.

     Providing records management briefings for all managers 
            and training to staff within their organizations, as 
            needed.

     Actively supporting managers, RLOs, staff and others in 
            carrying out their records management responsibilities.

  7.  Developing records management oversight roles and communication 
            networks with all program units including field offices and 
            other facilities, as appropriate, to ensure that the 
            records management program is implemented at all sites 
            under their jurisdiction.

  8.  Developing and disseminating directives and operating procedures, 
            as needed, to supplement Agency-wide policy to meet the 
            unique records management needs of their organizations and 
            to support a records management program within the 
            organization.

  9.  Ensuring records and other types of required documentary 
            materials are not unlawfully removed from EPA by current or 
            departing officials, employees, or agents.

    d. The General Counsel and Regional Counsel provide legal advice 
and counseling on records management issues as well as assist in 
determining the retention of Agency records that may be needed for 
legal purposes.
    e. The Inspector General assists in determining the retention of 
Agency records that may be needed for internal investigation and audit 
purposes.
    f. Managers and supervisors (Office Directors, Division Directors, 
Branch Chiefs, etc.) are responsible for:

  1.  Ensuring that a records management program is implemented within 
            their organization.

  2.  Understanding and emphasizing the importance of records 
            management to staff.

  3.  Designating selected staff as records contacts in order to meet 
            record-keeping requirements and responsibilities as 
            described in this document.

  4.  Providing support, time, and resources for records contacts to 
            successfully carry out their record-keeping 
            responsibilities.

  5.  Ensuring that the organization's file plans are current.

  6.  Obtaining training so that they and their staff can carry out 
            their record-keeping responsibilities.

  7.  Implementing an essential (vital) records program within the 
            organization.

  8.  Participating in records program reviews and assessments and 
            developing and implementing corrective action plans to 
            address gaps.

  9.  Supporting initiatives to move from paper to electronic record-
            keeping.

  10. Ensuring that all records of separating employees have been 
            identified, that temporary records that have met their 
            retention are properly disposed of according to applicable 
            records schedules, and that records that must be preserved 
            have been assigned to other employees.

    g. Headquarters, Regional, Laboratory/Center/Office RLOs are 
responsible for:

  1.  Creating and updating procedures for their offices in accordance 
            with established EPA and program policies.

  2.  Performing evaluations of their records management and essential 
            records program.

  3.  Developing file plans and procedures so records are organized and 
            can be found when needed.

  4.  Assisting with disposition activities, including retirement of 
            inactive records, transfer of permanent records to NARA, 
            and destruction in accordance with approved records 
            schedules.

  5.  Reviewing office-specific records schedules annually to ensure 
            they are current, and initiating changes if not.

  6.  Ensuring sensitive records are protected in accordance with 
            Federal and EPA requirements, and making sure designated 
            individuals maintain access lists to ensure such 
            information is released only to authorized individuals.

  7.  Coordinating the identification and maintenance of essential 
            (vital) records and submitting an annual inventory and 
            certification of essential (vital) records through senior 
            management to the Agency Records Officer.

  8.  Reviewing and verifying their organizations' section of the 
            Federal Records Centers invoices on a monthly basis 
            verifying the status of their off-site records and costs.

  9.  Conducting briefings and training sessions on the records 
            management program.

  10. Reviewing and recommending requests for records management 
            equipment, services and supplies.

  11. Obtaining NARA's Certificate in Federal Records Management.

  12. Completing Records Management Training for RLOs and Records 
            Contacts [http://intranet.epa.gov/records/training/rlo/
            index.html].

  13. Organizing, maintaining and training a network of records 
            contacts within the organization.

    h. Records contacts are responsible for:

  1.  Working within their organization as a liaison between the RLO 
            and staff to provide records management training, guidance 
            and support.

  2.  Being qualified and active in records management issues and 
            participating in records management training when resources 
            are available.

  3.  Creating file plans specific to their organization.

    i. Completing Records Management Training for RLOs and Records 
Contacts [http://intranet.epa.gov/records/training/rlo/index.html]. 
Information resources and system managers are responsible for:

  1.  Working with the local RLO, the Agency Records Officer and NARA 
            to establish and update records schedules for electronic 
            systems.

  2.  Implementing proper record-keeping procedures for existing 
            information systems and ensuring record-keeping 
            requirements are included in proposed systems.

  3.  Ensuring that information systems intended to carry out 
            electronic records management comply with NARA's and EPA's 
            requirements for electronic record-keeping systems (these 
            requirements available on the NRMP Intranet site [http://
            intranet.epa.gov/records/]

  4.  Maintaining electronic information systems in accordance with 
            approved records schedules and NARA requirements.

  5.  Working with their RLO to transfer permanent systems to the 
            National Archives in accordance with approved records 
            schedules and NARA requirements.

  6.  Ensuring that EPA Internet and Intranet postings containing 
            records are maintained in accordance with Agency record-
            keeping requirements.

  7.  Ensuring that prior approval is obtained before the removal of 
            SPII from the Agency network or facility.

  8.  Coordinating the handling of electronic records and information 
            with the local RLO/records management program and legal 
            office when appropriate.

    j. Project Officers (PO)/Contracting Officer Representatives (CORs) 
and Senior Employee Employment (SEE) program coordinators/monitors are 
responsible for:

  1.  Creating and maintaining appropriate records of the management 
            and oversight of their related projects, contracts, staff 
            and SEE employees.

    k. Continuity of Operations Program (COOP) planners are responsible 
for:

  1.  Working with records management staff to implement the essential 
            (vital) records plan to ensure the continuation of 
            designated COOP essential functions.

  2.  Ensuring that essential (vital) records are accessible from 
            designated COOP locations.

    l. All EPA employees are responsible for:

  1.  Creating and managing the records necessary to document the 
            Agency's official activities and actions, including those 
            records generated by EPA contractors and grantees, in 
            accordance with EPA record-keeping requirements.

  2.  Destroying records only in accordance with approved records 
            schedules and never removing records from EPA without 
            authorization.

  3.  Filing records for safe storage and efficient retrieval and 
            maintaining and disposing of personal papers and non-record 
            materials separately from records.

  4.  Ensuring that when secondary e-mail accounts for individuals, 
            groups or systems are created for business reasons, the 
            records thus created are appropriately managed.

  5.  Identifying all records, in any format, in the employee's 
            possession, and transferring them to another EPA custodian 
            before separating or transferring to another organization. 
            Note: Non-records and records which have met their 
            disposition per appropriate records schedule should be 
            destroyed unless subject to FOIA, litigation or audit. 
            Records containing SPII must be shredded.

  6.  Taking annual records management training and any other related 
            training and participating in records management activities 
            such as records management days, records clean-up days, 
            etc.

  7.  Contractors, grantees and others doing work on behalf of EPA are 
            required to take annual records management training, as 
            appropriate.
9. Definitions
    Definitions can also be found on EPA's National Records Management 
Program Website at http://intranet.epa.gov/records/.
    Approved Records Management System: (http://intranet.epa.gov/
records/.Approved) An agency records management application approved 
for storing electronic Federal records, including applications 
certified as compliant with the DOD 5015.2-STD standard or meeting the 
NARA standards for a records management application. Examples include 
EPA's Correspondence Management System and People Plus. [Need better 
example].
    Authorized Federal Information Management System: A major 
information system managed by a Federal agency which is used by other 
Federal agencies. Records in these systems are managed by the agency 
owning the system. Examples include Concur, Employee Express and eOPF.
    Destruction: In records management, the major type of disposal 
action. Non-records and records which have reached the end of their 
retention period per the appropriate record schedule can be legally 
destroyed. Records containing SPII must be shredded, pulped or burned, 
and never simply placed in the trash.
    Disposition: The actions taken regarding records no longer needed 
for current government business. These actions include transfer to 
agency storage facilities or Federal records centers, transfer from one 
Federal agency to another, transfer of permanent records to the 
National Archives, and disposal of temporary records. Disposition is 
the third stage of the records lifecycle, and the actions taken 
regarding non-record materials when no longer needed, including 
screening and destruction.
    Electronic messaging account: The term ``electronic messaging 
account'' means any account that sends electronic messages for purposes 
of communicating between individuals.
    Official EPA Information System: Any information system that EPA 
employees are permitted to access, create, share, store or transmit 
information on for official government business.
    Official record-keeping System: An ``information management system 
which captures, manages and provides access to records through time'' 
and can be electronic or paper-based, until an appropriate electronic 
record-keeping system becomes available.
    Records Schedule: Also called records disposition schedule, records 
control schedule, records retention schedule, records retention and 
disposition schedule, or schedule. A document that describes agency 
records, establishes a period for their retention by the agency, and 
provides mandatory instructions for what to do with them when they are 
no longer needed for current government business. The term refers to: 
(1) an SF 115, Request for Records Disposition Authority, that has been 
approved by NARA to authorize the disposition of Federal records; (2) a 
General Records Schedule (GRS) issued by NARA; and (3) a printed agency 
manual or directive containing the records descriptions and disposition 
instructions approved by NARA on one or more SF 115s or issued by NARA 
in the GRS. (Source: 36 CFR 1220.14)
    Registered Information Management System: An Agency electronic 
information system which has an associated records schedule or an 
information management system which holds records and is manually 
managed. Such EPA systems should be registered in the Agency's Registry 
of EPA Applications and Databases (READ) so they can be identified for 
scheduling, and the retention periods tracked. Examples include the 
Toxics Release Inventory Processing System (TRIPS), Safe Drinking Water 
Information System (SDWIS), and the Air Quality System (AQS).
    Transitory Record: Records of short-term (180 days or less) 
interest, including in electronic form (e.g., e-mail messages), which 
have minimal or no documentary or evidential value. An example of a 
transitory record is a record documenting routine activities containing 
no substantive information, such as routine notifications of meetings, 
scheduling of work-related trips and visits, and other scheduling 
related activities. See NARA GRS 23/ EPA 167.
10. Waivers
    a. Waiver Process. The Agency Records Officer may grant waivers to 
any provisions of this Policy for sufficient cause.
    b. Applications. Applications for waivers to specific provisions 
should contain: (1) identification of the Policy provision; (2) a 
listing of reasons why the Policy cannot be applied or maintained; (3) 
an assessment of impacts resulting from non-compliance; and (4) the 
signature of the AA, RA or Laboratory/Center/Office Director, the Chief 
Financial Officer, the General Counsel, or the Inspector General 
responsible for the records management program in question.
    c. Notification. The Agency Records Officer will notify the 
requesting office in writing of the decision on the waiver request 
within two weeks of receipt of the request. Circumstances will dictate 
whether the waiver may be renewed.
11. Related Procedures, Standards and Guidance
    Required procedures and implementation guidelines for this Policy 
are found on the records management website [http://www.epa.gov/
records/]. Supporting procedures to implement this Policy at the 
Program Office or other Administrative level must be approved by the 
Agency Records Officer in OEI.
12. Material Superseded
    CIO 2155.2: Interim Records Management Policy, Dated 06/28/13.
    EPA IRM Policy Manual, Chapter 10, 1996.
    Vital Records Order (Order 2160.1).
13. Additional Information
    For further information about this Policy, please contact the EPA 
Office of Environmental Information, Office of Information Collection.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

Renee P. Wynn,
Acting Assistant Administrator for Environmental Information and Chief 
Information Officer,
U.S. Environmental Protection Agency.

                                  [all]