[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
STATUS OF REFORMS TO EPA'S
INTEGRATED RISK INFORMATION SYSTEM
=======================================================================
JOINT HEARING
BEFORE THE
SUBCOMMITTEE ON OVERSIGHT &
SUBCOMMITTEE ON ENVIRONMENT
COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
JULY 16, 2014
__________
Serial No. 113-86
__________
Printed for the use of the Committee on Science, Space, and Technology
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Available via the World Wide Web: http://science.house.gov
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COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
HON. LAMAR S. SMITH, Texas, Chair
DANA ROHRABACHER, California EDDIE BERNICE JOHNSON, Texas
RALPH M. HALL, Texas ZOE LOFGREN, California
F. JAMES SENSENBRENNER, JR., DANIEL LIPINSKI, Illinois
Wisconsin DONNA F. EDWARDS, Maryland
FRANK D. LUCAS, Oklahoma FREDERICA S. WILSON, Florida
RANDY NEUGEBAUER, Texas SUZANNE BONAMICI, Oregon
MICHAEL T. McCAUL, Texas ERIC SWALWELL, California
PAUL C. BROUN, Georgia DAN MAFFEI, New York
STEVEN M. PALAZZO, Mississippi ALAN GRAYSON, Florida
MO BROOKS, Alabama JOSEPH KENNEDY III, Massachusetts
RANDY HULTGREN, Illinois SCOTT PETERS, California
LARRY BUCSHON, Indiana DEREK KILMER, Washington
STEVE STOCKMAN, Texas AMI BERA, California
BILL POSEY, Florida ELIZABETH ESTY, Connecticut
CYNTHIA LUMMIS, Wyoming MARC VEASEY, Texas
DAVID SCHWEIKERT, Arizona JULIA BROWNLEY, California
THOMAS MASSIE, Kentucky ROBIN KELLY, Illinois
KEVIN CRAMER, North Dakota KATHERINE CLARK, Massachusetts
JIM BRIDENSTINE, Oklahoma
RANDY WEBER, Texas
CHRIS COLLINS, New York
BILL JOHNSON, Ohio
------
Subcommittee on Oversight
HON. PAUL C. BROUN, Georgia, Chair
F. JAMES SENSENBRENNER, JR., DAN MAFFEI, New York
Wisconsin ERIC SWALWELL, California
BILL POSEY, Florida SCOTT PETERS, California
KEVIN CRAMER, North Dakota EDDIE BERNICE JOHNSON, Texas
BILL JOHNSON, Ohio
LAMAR S. SMITH, Texas
------
Subcommittee on Environment
HON. DAVID SCHWEIKERT, Arizona, Chair
JIM BRIDENSTINE, Oklahoma SUZANNE BONAMICI, Oregon
F. JAMES SENSENBRENNER, JR., JULIA BROWNLEY, California
Wisconsin DONNA F. EDWARDS, Maryland
DANA ROHRABACHER, California ALAN GRAYSON, Florida
RANDY NEUGEBAUER, Texas KATHERINE CLARK, Massachusetts
PAUL C. BROUN, Georgia EDDIE BERNICE JOHNSON, Texas
RANDY WEBER, Texas
LAMAR S. SMITH, Texas
C O N T E N T S
July 16, 2014
Page
Witness List..................................................... 2
Hearing Charter.................................................. 3
Opening Statements
Statement by Representative Paul C. Broun, Chairman, Subcommittee
on Oversight, Committee on Science, Space, and Technology, U.S.
House of Representatives....................................... 9
Written Statement............................................ 10
Statement by Representative Suzanne Bonamici, Ranking Minority
Member, Subcommittee on Environment, Committee on Science,
Space, and Technology, U.S. House of Representatives........... 11
Written Statement............................................ 13
Statement by Representative David Schweikert, Chairman,
Subcommittee on Environment, Committee on Science, Space, and
Technology, U.S. House of Representatives...................... 14
Written Statement............................................ 14
Witnesses:
Dr. David Dorman, Member, Committee to Review EPA's IRIS Process,
National Research Council
Oral Statement............................................... 16
Submitted Biography.......................................... 18
Dr. Kenneth Olden, Director, National Center for Environmental
Assessment, U.S. Environmental Protection Agency
Oral Statement............................................... 28
Written Statement............................................ 30
Ms. Rena Steinzor, Professor of Law, University of Maryland;
President, Center for Progressive Reform
Oral Statement............................................... 39
Written Statement............................................ 41
Mr. Michael P. Walls, Vice President of Regulatory and Technical
Affairs, American Chemistry Council
Oral Statement............................................... 75
Written Statement............................................ 77
Discussion....................................................... 87
Appendix I: Answers to Post-Hearing Questions
Dr. David Dorman, Member, Committee to Review EPA's IRIS Process,
National Research Council...................................... 96
Dr. Kenneth Olden, Director, National Center for Environmental
Assessment, U.S. Environmental Protection Agency............... 100
Ms. Rena Steinzor, Professor of Law, University of Maryland;
President, Center for Progressive Reform....................... 114
Mr. Michael P. Walls, Vice President of Regulatory and Technical
Affairs, American Chemistry Council............................ 123
Appendix II: Additional Material for the Record
Prepared statement by Representative Eddie Bernice Johnson,
Ranking Member, Committee on Science, Space, and Technology,
U.S. House of Representatives.................................. 128
STATUS OF REFORMS TO EPA'S
INTEGRATED RISK INFORMATION SYSTEM
----------
WEDNESDAY, JULY 16, 2014
House of Representatives,
Subcommittee on Oversight and Subcommittee on
Environment,
Committee on Science, Space, and Technology,
Washington, D.C.
The Subcommittees met, pursuant to call, at 1:32 p.m., in
Room 2318 of the Rayburn House Office Building, Hon. Paul Broun
[Chairman of the Subcommittee on Oversight] presiding.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Chairman Broun. Good afternoon. This joint hearing of the
Subcommittee of Oversight and the Subcommittee on Environment
will come to order. Good afternoon, everyone. We welcome you to
today's joint hearing. In front of you are packets containing
the written testimony, biographies, and truth in testimony
disclosures for today's witnesses.
Before we get started, since this is a joint hearing
involving two Subcommittees, I want to explain how we will
operate procedurally, so all Members understand how the
question and answer period will be handled. We will recognize
those Members present at the gavel in order of seniority on the
Full Committee, and those coming in after the gavel will be
recognized in the order of arrival.
And before I give my opening statement, I want to thank--
publicly thank the witnesses, as well as Members, and staff on
both sides for your flexibility. We have a long series of votes
that are going to occur about 2:30, 2:45 this afternoon. We
wanted to have plenty of time for Members, as well as the
witnesses, to give their statements and ask and answer
questions, and so I deeply appreciate everyone's flexibility in
this. Now the Chairman recognizes himself for five minutes for
an opening statement.
Again, I would like to welcome and thank all of our
witnesses for being here today, and for your flexibility in
coming in early to accommodate our vote schedule. We don't have
control over such matters, so I especially appreciate you all
and the Members' cooperation.
Over the past decade, this Committee has held many
oversight hearings to examine the EPA's Integrated Risk
Information System, or IRIS program. As you all know, IRIS was
established three decades ago to provide a single source of
information on the risk associated with exposure to
environmental chemicals for use by EPA regulatory offices,
states, the international community, as well as industry.
Unfortunately, the program has come under increased
scrutiny as a result of issues related to the pace of
assessments, the lack of transparency, and failure to develop
and use consistent approaches to weighing evidence, and
characterizing risk in a manner divorced from actual human
exposures.
This scrutiny has come in many forms. Internally, from the
EPA program offices, which have established their own chemical
assessments separate from ours, as well as other federal
agencies, including the White House, and externally from
stakeholder groups that have increasingly weighed in to express
their concern about IRIS assessments. Even the U.S. Government
Accountability Office placed the program on its high risk
series, a list it provides to Congress every two years, for
being at high risk for waste, fraud, abuse, and mismanagement,
or in need of broad based transformation.
Congress, and especially this Committee, has shined a
spotlight on the IRIS program for several years, particularly
as the National Research Council has been directed to review
some of the more complex and challenging IRIS assessments. One
such example is the 2011 formaldehyde assessment. When the NRC
published their review, it went beyond its charge to add a very
pointed and critical chapter seven in their report that offered
recommendations and suggestions on how EPA could improve the
IRIS process. That eventually led to the NRC report published
this May, which identified ``substantial improvements'' in the
initial stages of EPA's proposed changes to the IRIS program.
That is quite a turnaround from the 2011 report, and I was
pleased to read that, just as I was pleased to read when EPA
announced two years ago that it had tapped Dr. Ken Olden to
lead the agency's National Center for Environmental Assessment.
Dr. Olden has been a refreshing ambassador for the IRIS
program, and I applaud his commitment to an open and
transparent IRIS process that includes early communication, and
increased opportunities for meaningful stakeholder input.
But it is clear that the objective of transparency is not a
sentiment shared by all. Unfortunately, we have seen opposition
to openness, transparency, and greater public comment from some
corners. Sunshine is the only way to ensure that this reform
effort succeeds, and anti-industry conspiracy theories, and the
boycotting of public meetings do not help the program improve.
Dr. Olden and his staff should be commended for opening up the
process to all stakeholders, and I greatly appreciate your
efforts, Dr. Olden, in that regard.
With that, I am interested in learning more about EPA's
timeline on when it expects to complete its reform process,
and, more importantly, when it will publish IRIS assessments
that reflect the recommendations and suggestions offered by the
NRC to substantially improve the program.
IRIS will be considered a success when the science behind
the assessments is viewed by all stakeholders as rigorous and
accurate. The real metric for progress for IRIS should be the
actual content of the assessments. Are they credible? Do they
correctly characterize risk and uncertainty? Can users trust
them? Are they overly conservative in a way that limits the
options available to risk managers? If EPA develops such
guidelines, handbooks, or policies, then fails to consistently
follow them, we will have spent years, and millions of
taxpayers' dollars to reform IRIS on paper.
As a physician, I understand how important it is to ensure
the best possible scientific methods are being utilized to
protect our most sensitive populations, including children,
pregnant women, and the elderly, all from undue harm. Because
of this widespread use, we must be certain that the IRIS
program is using the best possible science, and scientific
process, in a timely fashion to publish assessments that
engender confidence by all stakeholders. Anything less than
that is a mission not accomplished. Thank you.
[The prepared statement of Mr. Broun follows:]
Prepared Statement of Subcommittee on Oversight
Chairman Paul Broun
Good afternoon. I want to welcome and thank all of our witnesses
for being here today.
Over the past decade, this Committee has held many oversight
hearings to examine the EPA's Integrated Risk Information System, or
IRIS program. As you all know, IRIS was established three decades ago
to provide a single source of information on the risks associated with
exposure to environmental chemicals for use by EPA regulatory offices,
states, the international community, and industry. Unfortunately, the
program has come under increased scrutiny as a result of issues related
to the pace of assessments, lack of transparency, failure to develop
and use consistent approaches to weighing evidence, and characterizing
risks in a manner divorced from actual human exposures.
This scrutiny has come in many forms: internally, from EPA program
offices--who have established their own chemical assessments separate
from IRIS - as well as other federal agencies, including the White
House, and externally, from stakeholder groups who have increasingly
weighed in to express their concerns about IRIS assessments. Even the
U.S. Government Accountability Office placed the program on its High-
Risk series, a list it provides to Congress every two years, for being
at high risk for waste, fraud, abuse, and mismanagement or in need of
broad-based transformation.
Congress, and especially this Committee, has shined the spotlight
on the IRIS program for several years, particularly as the National
Research Council has been directed to review some of the more complex
and challenging IRIS assessments. One such example is the 2011
formaldehyde assessment. When the NRC published that review, it went
beyond its charge to add a very pointed and critical Chapter Seven in
the report that offered recommendations and suggestions on how EPA
could improve the IRIS process. That eventually led to the NRC report
published this May, which identified ``substantial improvements'' in
the initial stages of EPA's proposed changes to the IRIS program.
That is quite a turn-around from the 2011 report, and I was pleased
to read that, just as I was pleased when EPA announced two years ago
that it had tapped Dr. Ken Olden to lead the agency's National Center
for Environmental Assessment. Dr. Olden has been a refreshing
ambassador for the IRIS program and I applaud his commitment to an open
and transparent IRIS process that includes early communication and
increased opportunities for meaningful stakeholder input.
But it is clear that the objective of transparency is not a
sentiment shared by all. Unfortunately, we have seen opposition to
openness, transparency, and greater public comment from some corners.
Sunshine is the only way to ensure that this reform effort succeeds,
and anti-industry conspiracy theories and the boycotting of public
meetings do not help the program improve. Dr. Olden and his staff
should be commended for opening up the process to all stakeholders.
With that, I am interested in learning more about EPA's timeline on
when it expects to complete its reform process, and more importantly,
when it will publish IRIS assessments that reflect the recommendations
and suggestions offered by the NRC to substantially improve the
program. IRIS will be considered a success when the science behind the
assessments is viewed by all stakeholders as rigorous and accurate. The
real metric for progress for IRIS should be the actual content of the
assessments. Are they credible? Do they correctly characterize risk and
uncertainty? Can users trust them? Are they overly conservative in a
way that limits the options available to risk managers? If EPA develops
useful guidelines, handbooks, or policies, then fails to consistently
follow them, we will have spent years and millions of dollars to reform
IRIS on paper.
As a physician, I understand how important it is to ensure the best
possible scientific methods are being utilized to protect our most
sensitive populations, including, children, pregnant women, and the
elderly, from undue harm. Because of its widespread use, we must be
certain that the IRIS program is using the best possible science and
scientific process in a timely fashion to publish assessments that
engender confidence by all stakeholders. Anything less than that is a
mission not accomplished.
Thank you. I now recognize the Ranking Member, the gentleman from
New York, Mr. Maffei, for anopening statement.
Chairman Broun. And now I recognize the Ranking Member of
the Environment Subcommittee, Ms. Bonamici, for an opening
statement.
Ms. Bonamici. Thank you very much, Mr. Chairman. And thank
you to our witnesses for testifying before the Subcommittees
today. I want to note that the absence of more Members on this
side is not indicative of our concern about the issue. The
change in time and conflicting hearings are to blame.
So I also want to start by emphasizing, on behalf of my
colleagues on my side of the aisle, that we are not anti-
industry, nor are we opposed to the development of new
chemicals. We simply want to ensure that scientific information
is available to determine the health effects that might result
from exposure. This is about protecting human health. I am glad
you recognize that, Mr. Chairman.
The Integrated Risk Information System, IRIS, was intended
to be a database that would provide a comprehensive source of
best information on the health risks of chemicals.
Approximately 700 new chemicals enter the market every year,
joining about 85,000 industrial chemicals already in use.
Companies that manufacture, distribute, or use these chemicals
are not required to demonstrate that the chemicals are safe.
When a company wants to introduce a new chemical, the
company notifies the EPA, but the company is not required to
share any data regarding the safety of that chemical. EPA
cannot even request safety data unless it can show that there
is a potential risk by pointing to available academic or
industry data. It often takes many years before harms
associated with the chemical can begin to be identified. Thus,
there is no good public safety check in place.
There is what seems to be an obvious need for transparency.
Despite that, since the 1990s, the industry appears to have
used some strategies to try to slow IRIS entries, tie EPA up in
lengthy reviews and inter-agency dialogues, or generally cast
doubt on claims that a particular chemical might have an
adverse health effect.
For example, during the Bush Administration, the Office of
Management and Budget hired a toxicologist and epidemiologist
to run so-called peer reviews of draft IRIS entries, a policy
that resulted in endless requests from OMB that EPA go back and
look at different literature, or make minor changes to their
findings. The Bush Administration also created an inter-agency
review process that allowed agencies with significant pollution
problems to challenge the EPA IRIS drafts. Production of new
IRIS assessments was so slow that the GAO put IRIS on their
watch list--you mentioned that, Mr. Chair--and there was a
bipartisan push to let EPA take control of their program and
expand their productivity.
The Obama Administration sought to strengthen IRIS, and
moved OMB into the background while lessening unnecessary
inter-agency review mechanisms. The response from those who are
opposed to IRIS has been to call on the National Research
Council to continually review IRIS assessments. The NRC was
drawn into IRIS several times prior to the 2011 formaldehyde
review. In each case, they largely supported EPA's findings,
but offered advice about how to complete more systematic
reviews, and how to improve the science assessments.
Invariably, the overall assessments of EPA's findings were lost
in the noise about what the EPA did not do, or could have done
better.
The 2011 report was a little different. The National
Research Council used that report to praise the substantial
improvements--thank you, Dr. Olden--made by the EPA thus far,
and offer a road map how to make IRIS more efficient to
accelerate and streamline the assessments. EPA embraced the
advice of the NRC, and, as the most recent report acknowledges,
has made significant progress in putting into place the process
reforms recommended in 2011.
Now we are faced with a question. What is the National
Academy's off-ramp strategy for getting out of the business of
doing endless IRIS reviews? Questions have been raised about
whether the American Chemistry Council may have an interest in
keeping IRIS unproductive. Does every NRC report offer an
opportunity for criticisms about the quality of the science at
the EPA? These are issues we hope you will address today.
At this point I am very interested to hear whether the
Academy has reached the end of its productive contributions. If
not, where is that point? Frankly, the combination of the 2011
report, the new leadership at the Center for Environmental
Assessment, which has focused on building a better relationship
with industry, has had the effect of crippling IRIS, rather
than putting the EPA on a path to streamline production of IRIS
entries. In fact, unless changes are implemented, it very well
may cripple the program as much as when OMB was involved, with
repeated peer reviews. So I am very interested to hear from Dr.
Olden what you intend to do to get production of IRIS
assessments moving.
I look forward to the testimony from each of the witnesses.
There have been a lot of questions raised, but, importantly,
this Committee needs to hear how we are going to get out of the
way, let EPA do its job of producing assessments of chemicals
that may be suspected of, and may be causing harm to our
constituents and our communities. Thank you very much, Mr.
Chairman, and I yield back.
[The prepared statement of Ms. Bonamici follows:]
Prepared Statement of Subcommittee on Environment
Ranking Minority Member Suzanne Bonamici
Thank you, Mr. Chairman, and thank you to our witnesses for
testifying before our Subcommittees today. I want to start by
emphasizing on behalf of my side of the aisle that we are not anti-
chemical or opposed to the development of new chemicals--we simply want
to assure that scientific information is available to determine the
health effects that might result from exposure. This is about
protecting human health.
The Integrated Risk Information System, IRIS, was intended to be a
database that would provide a comprehensive source of best information
on the health risks of chemicals. Approximately seven hundred new
chemicals enter the market every year, joining about 85,000 industrial
chemicals already in use. Companies that manufacture, distribute, or
use these chemicals are not required to demonstrate that the chemicals
are safe.
When a company wants to introduce a new chemical, the company
notifies the EPA, but the company is not required to share any data
regarding the safety of that chemical. EPA cannot even request safety
data unless it can show there is a potential risk by pointing to
available academic or industry data. It often takes many years before
harms associated with a chemical can begin to be identified, thus there
is no good public safety check in place.
There is what seems to be an obvious need for transparency. Despite
that, since the 1990s the chemical industry appears to have used
strategies to try to slow IRIS entries, tie EPA up in lengthy reviews
and interagency dialogues, and generally cast doubt on claims that a
particular chemical might have an adverse health effect. For example,
during the Bush Administration, the Office of Management and Budget
hired a toxicologist and an epidemiologist to run so-called ``peer
reviews'' of draft IRIS entries, a policy that resulted in endless
requests from OMB that EPA go back and look at different literature or
make minor changes to their findings. The Bush Administration also
created an interagency review process that allowed agencies with
significant pollution problems to challenge the EPA IRIS drafts.
Production of new IRIS assessments was so slow that GAO put IRIS on
their ``watch list,'' and there was a bipartisan push to let EPA take
control of their program and expand their productivity.
The Obama Administration sought to strengthen IRIS, and moved OMB
into the background while lessening unnecessary interagency review
mechanisms. The response from those who are opposed to IRIS's work has
been to call on the National Research Council to continually review
IRIS assessments. The NRC was drawn into IRIS several times prior to
the 2011 Formaldehyde review. In each case they largely supported EPA's
findings, but offered advice about how to complete more systematic
reviews and how to improve the science assessments. Invariably, the
overall endorsements of EPA's findings were lost in the noise about
what EPA did not do or could have done better.
The 2011 report was a little different. The National Research
Council (NRC) used that report to praise the substantial improvements
made by EPA thus far, and offer a road map for how to make IRIS more
efficient, and to accelerate and streamline the assessments. EPA
embraced the advice of the NRC and, as the most recent report
acknowledges, has made significant progress in putting into place the
process reforms recommended in 2011. Now we are faced with a necessary
question: what is the National Academy's off-ramp strategy for getting
out of the business of doing endless IRIS reviews? Organizations such
as the American Chemistry Council may have an interest in keeping IRIS
unproductive, and discrediting its work could keep the Academy busy as
every NRC report offers an opportunity for criticisms about the quality
of the science at EPA. At this point, I am very interested to hear
whether the Academy has reached the end of its productive
contributions. If they have not reached that point, where might that
point be?
Frankly the combination of the 2011 report and the new leadership
at the National Center for Environmental Assessment, which has focused
on building a better relationship with industry, has had the effect of
crippling IRIS rather than putting the EPA on a path to streamlined
production of IRIS entries. In fact, unless changes are implemented, it
may very well cripple the program as much as when OMB was involved with
repeated ``peer reviews.'' So I am very interested to hear from Dr.
Olden about what he intends to do to get production of IRIS assessments
moving.
I look forward to the testimony from each of the witnesses. But
importantly, this Committee needs to hear how we are going to get out
of the way and let EPA do its job of producing assessments of chemicals
that are suspected of and may be causing harm to our constituents and
our communities.
Chairman Broun. Thank you, Ms. Bonamici. Now the Chair
recognizes the Chairman of the Subcommittee on Environment, the
gentleman from Arizona, Mr. Schweikert, for his opening
statement. You are recognized for five minutes.
Mr. Schweikert. Thank you, Mr. Chairman. We will do this
quickly, to be economical with time, because of the votes
coming up. Welcome to the chaos of this time of year.
I have three quick things. One, I need to say goodbye to
Mr. Woods here, though his unwillingness to shave demonstrates
he knows he is leaving us this coming week. Number two,
something that almost has never happened in my couple years
around here, I talked to some folks who care very much about
what is done here, and they actually said nice things about
you, Dr. Olden. You have no idea how rare it is to hear nice
things about anyone around here.
And, number three, one of the comments that came up, both
from some folks I met who you consider on the left and the
right, is the encouragement and the hope that the continued
movement to be more transparent with data, so folks can review
and understand, continues. There was a great warmth from both
sides that was heading in the right direction. With that, Mr.
Chairman, I yield back.
[The prepared statement of Mr. Schweikert follows:]
Prepared Statement of Environment Subcommittee
Chairman David Schweikert
EPA's Integrated Risk Information System, or ``IRIS,'' is designed
to provide quantitative and non-quantitative toxicity information for a
suite of chemicals. The purpose of this program is to provide basic
scientific determinations about what is a safe level and to be used by
both EPA program offices and States.
This program has never been authorized by Congress and, over the
last decade, has been strongly criticized by the National Academy of
Sciences, the Government Accountability Office (it was listed as a
``High risk'' program in 2009 and remains on the list), the
environmental community, industry, and both parties.
The National Research Council rightly found that critical reforms
that promote greater openness, transparency, and stakeholder engagement
are currently underway by EPA, led by Dr. Ken Olden.
It is important to note that these limited reforms are simply a
work in progress--not a single complete assessment has benefited from
this new framework. The NRC report was a snapshot in time, and even
these limited reforms have been criticized in some corners.
Specifically, the NRC called on EPA to:
Increase the transparency of how IRIS assessments are
conducted and of the criteria EPA uses;
Adopt better methodologies for systematic review of the
literature, for evaluating evidence, and for integrating evidence
across different types of scientific information;
Rely on more high quality studies;
Conduct better peer review;
Increase the role of outside experts; and
Better manage the program to improve its efficiency and
to stay current with scientific advances.
Most of these reforms have focused on process, but there are key
areas in the content of these assessments that limit their credibility.
States, industry, and the public do not trust the IRIS assessments.
The former Science Advisor for EPA recently wrote in Nature that:
``Fundamentally, the EPA should replace risk values that are built on
science-policy assumptions with risk estimates that acknowledge
underlying uncertainties. The EPA's definitive values are illusions;
they conceal uncertainty that cannot be resolved scientifically.''
Chairman Broun. Well, that was quick. Thank you, Mr.
Schweikert. If there are Members who wish to submit additional
opening comments or statements, your statements will be added
to the record at this point.
Chairman Broun. At this time I would like to introduce our
panel of witnesses. Our first witness is Dr. David Dorman,
member of the National Research Council's Committee to Review
the EPA's IRIS Process.
Our second witness, and star, is Dr. Ken Olden, Director of
the National Center for Environmental Assessment at the U.S.
Environmental Protection Agency. And, I just want to reiterate
what Mr. Schweikert said. It is just so nice to have good
comments, and it is rare around here, Dr. Olden.
Our third witness is Ms. Rena Steinzor, Professor of Law at
the University of Maryland, and President of the Center for
Progressive Reform. Glad to have you, as well as our final
witness, Mr. Michael Walls, Vice President of Regulatory and
Technical Affairs at the American Chemistry Council.
Now, as the witnesses should know, spoken testimony is
limited to five minutes each, and if you would please try to
limit your comments to five minutes. I am not going to gavel
you down, but we do have votes forthcoming fairly quickly. So
if you would, please try to limit your comments to five
minutes, after which Members of the committee will have five
minutes each to ask questions.
It is the practice of the Subcommittee on Oversight to
receive testimony under oath. If you would all please stand.
Raise your right hand. Do you solemnly swear to affirm to tell
the whole truth, and nothing but the truth, so help you God?
Dr. Dorman? Okay, very good. You may be seated. Let the record
reflect that the witnesses participating have all taken the
oath.
I now recognize Dr. Dorman for five minutes.
TESTIMONY OF DR. DAVID DORMAN,
MEMBER, COMMITTEE TO REVIEW EPA'S IRIS PROCESS,
NATIONAL RESEARCH COUNCIL
Dr. Dorman. Okay. Good afternoon, Dr. Broun, Chairman
Schweikert, Ranking Member Bonamici, and other Members of the
Subcommittees. My name is David Dorman. I am a professor of
toxicology at North Carolina State University, and I served as
a member of the National Research Council Committees to review
the IRIS process, and the NRC Committee to review EPA's draft
IRIS assessment of Formaldehyde. I am pleased to appear before
you today to discuss aspects of the report, ``Review of EPA's
Integrated Risk Information System Process'', which was
released earlier this year, in May of 2014.
This report, which I have a copy of, and--was written by a
15 member committee of the National Research Council of the
National Academies. The committee was asked to assess the
scientific, technical, and process changes being implemented or
planned by EPA, and to recommend modifications, or additional
changes, as appropriate, to try to improve the scientific and
technical performance of the IRIS process. Recommendations in
the earlier NRC formaldehyde report, as mentioned earlier,
provided the impetus for the changes to EPA's IRIS program.
Overall, the IRIS committee found that the changes that EPA
has proposed and implemented to various degrees constitute
substantial improvements in the IRIS process. If current
trajectories are maintained, some of the inconsistencies
identified in our report are addressed, and planned revisions
still to be implemented are successfully completed, the IRIS
process will become much more effective and efficient in
achieving the program's basic goal of developing assessments
that provide an evidence-based foundation for ensuring that
chemical hazards are optimally addressed, and assessed through
a transparent and replicable approach.
The IRIS committee reviewed and evaluated the overall
process, and each individual step of the process, and the
changes that EPA has made, or is planning to make, and offered
recommendations. Additionally, the IRIS committee identified
three broad areas on which the EPA should focus attention.
First, EPA's assessment methods will need to be updated in
a continuing strategic process, and EPA should develop a plan
for doing so. Second, the sources of inefficiencies in the IRIS
process need to be identified and addressed systematically.
Third, EPA management needs to evaluate human and technologic
resources that are needed to conduct IRIS assessments, and
support methodologic research, and the implementation of new
approaches. The IRIS committee emphasized that if sufficient
financial and staff resources are not available to EPA, then it
will not be able to continue to improve the IRIS program, and
keep pace with scientific advancement.
As noted, the IRIS committee found that substantial
improvements in the IRIS process have been made, and it is
clear that EPA has embraced, and is acting on the
recommendations in the NRC formaldehyde report. The NRC
formaldehyde committee recognized that these suggested changes
would take several years, and an extensive effort on the part
of EPA staff to implement. Substantial progress, however, has
been made in a short time, and the IRIS committee's
recommendation should be seen as building on the progress that
EPA has already made.
Thank you for the opportunity to testify, and I would be
happy to answer any questions that the Committee would like me
to address. Thank you.
[The prepared statement of Dr. Dorman follows:]
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Chairman Broun. Thank you, Dr. Dorman. The Chair now
recognizes Dr. Olden for five minutes.
TESTIMONY OF DR. KENNETH OLDEN, DIRECTOR,
NATIONAL CENTER FOR ENVIRONMENTAL ASSESSMENT,
U.S. ENVIRONMENTAL PROTECTION AGENCY
Dr. Olden. Good afternoon, Chairman Broun, Ranking Member
Maffei, Chairman Schweikert, and Ranking Member Bonamici, and
distinguished Members of the Committee. My name is Kenneth
Olden, and I am the director of the National Center for
Environmental Assessment, in the Office of Research and
Development in the U.S. Environmental Protection Agency. We
appreciate your interest in the Integrated Risk Information
System, commonly called IRIS. Today I am pleased to report that
the changes that we have made in the program over the past two
years have been welcomed, and well received.
A May 2014 report by the National Academies National
Research Council commended our progress, and recognized that we
have made a tremendous amount of progress in a short time. Yes,
we are pleased that the NRC committee recognized the progress
that we have made. However, it is not time to celebrate, or to
declare victory. In fact, we are humbled by the work that
remains to be done.
Our vision is to complete the transformation of IRIS into a
highly effective world class scientific enterprise. To achieve
this objective, the IRIS program has embraced the use of the
best science and informational technologies available to
estimate the risk from chemical exposures. Furthermore, we have
instituted several structural and programmatic changes to
ensure transparency, objectivity, and scientific rigor in the
assessment process.
In the interest of time, I will highlight three in my oral
testimony today. First, we incorporated principles of
systematic structured review methodologies to identify, to
evaluate, and to integrate data from the three different
evidence streams that we use in toxicity--in estimation of
toxicity values. These approaches make use of explicit pre-
specified rules to select, to evaluate, and to synthesize data
relevant to the specific chemical assessment. Such approaches
give results that are highly reproducible, and eliminate bias
associated with expert judgment.
However, I might add that methodologies used in systematic
review and evidence integration were developed for the use of
evidence medicine. In such cases, one is comparing
effectiveness of Drug A versus Drug B in a chemical trial. In
the case of IRIS assessments, we are integrating evidence from
three streams, epidemiology, animal studies, and mode of
action, or mechanistic studies.
Except for the Bradford-Hill guidelines used in cancer
hazard assessment, the effectiveness and potential for risk of
bias for integration of evidence from such diverse sources
using these methodologies have not been evaluated. While useful
in evidence-based medicine, these methodologies may need to be
customized for IRIS purposes. However, I caution that we do not
want to make the structured process so rigid as to exclude
expert judgment. In the end, we may end up with a process that
combines expert judgment with some sort of structured approach.
Second, we instituted activities to proactively engage the
public during critical stages of the assessment process. For
example, we hold bimonthly IRIS public meetings to discuss
scientific issues related to preliminary assessment materials
and draft IRIS assessments. These meetings provide opportunity
for public input on the literature identified, and evidence
tables that we have prepared for use in the assessment. For
example, have we failed to identify all the studies pertinent
to the assessment? Have we identified the right disease
endpoints likely to be caused by the specific chemical
exposure?
And finally, to improve quality and consistency of peer
review, we have created a standing chemical assessment advisory
committee under the auspices of EPA's Scientific Advisory Board
to conduct peer review of IRIS assessments. Since we will have
regular and frequent interactions with this committee, systemic
and recurring problems can be defined and eliminated, and
consensus opinions of the committee will provide quality
assurance, and will lend credibility to the assessments.
Moreover, impetus to be responsive to the peer review
recommendations will be much higher. However, it is my job to
ensure the quality and integrity of IRIS assessments.
And, in summary, the transformation of IRIS is well
underway. As the individual with primary responsibility for the
IRIS program, I can assure you that the EPA fully intends to
successfully complete the transformation. The recommendations
made by the NRC committees are absolutely consistent with our
commitment to transparency and scientific excellence. While we
are fully cognizant of the urgency to completely implement the
NRC recommendations, our number one priority is to get the
science and the process right.
Thank you, and I would be pleased to respond to any
questions that you might have.
[The prepared statement of Dr. Olden follows:]
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Chairman Broun. Thank you, Dr. Olden. Ms. Steinzor, you are
recognized for five minutes.
TESTIMONY OF MS. RENA STEINZOR,
PROFESSOR OF LAW, UNIVERSITY OF MARYLAND;
RESIDENT, CENTER FOR PROGRESSIVE REFORM
Ms. Steinzor. Thank you for the opportunity to testify this
afternoon about how to get EPA's IRIS program back on track.
IRIS assessments are invaluable because they are robust and
well documented, are summarized clearly and concisely, and are
available to anyone who has access to the Internet.
Individuals, community groups, public interest organizations,
government officials, in short, everyone, not just in this
country, but around the world, can get information they need to
make well informed decisions about toxic hazards. Conversely,
delaying the production of IRIS profiles causes real and
devastating harm to public health. It also saves the chemical
industry lots of money.
My testimony today makes three points. First, IRIS
assessments have once again slowed to a crawl, sinking to the
depths of the poor performance achieved under the Bush
Administration. The Obama Administration needs to stop
jawboning with industry stakeholders, and concentrate on
revitalizing this vital initiative.
The highest best use of the National Academy's expertise
would be to help the IRIS program identify ways to develop a
significantly larger number of robust assessments quickly, on a
limited budget. Congress, the EPA administrator, and the
National Academies must confront the very serious problem of
regulated industry's commandeering the IRIS assessment process
by barraging the agency with endless minor repetitive and
irrelevant objections to risk assessments.
Unfortunately, although its potential is great, IRIS's
promise is compromised by disturbing data gaps. As GAO has
reported, IRIS is rapidly becoming one of EPA's walking dead
programs. The agency's efforts to fill IRIS's data gaps were
largely stymied during the Bush Administration, and not by
accident. That administration imposed reforms designed to
subject EPA's scientists to a host of political pressures from
government agencies with neither scientific expertise, nor an
interest in protecting public health and the environment.
The Obama Administration recognized the problem, but its
revisions to the IRIS process left key issues unaddressed. Of
late, the administration has displayed a disturbing tendency to
retreat in the face of a blistering and self-serving industry
campaign to stifle this vital program once and for all.
The two National Academies committees responsible for
reviewing IRIS have missed golden opportunities to provide
constructive advice on how to develop new assessments quickly.
Rather than flyspecking the faults of specific IRIS
assessments, and subjecting the program as a whole to a round
robin of highly critical examination, three issues must be
addressed to solve this problem, revamping the IRIS program's
agenda, adopting so-called stopping rules, and ending
duplicative rounds of stakeholder consultations dominated by
regulated industries.
Once EPA starts an IRIS assessment, there must be an end in
sight, an assessment must be declared finished, and its results
posted on the web. When significant new science is produced
suggesting that the numbers must be lowered or raised, EPA can
re-examine the profile. But as exemplified by the chromium
compound assessment, regulated industries often manage to push
EPA onto a treadmill, where it never escapes the wait for
another study. The trouble, of course, is that science is
always evolving. EPA cannot wait on all the science to resolve
itself, and the truth to be announced. That simply is not the
nature of the scientific enterprise.
The final problem is the decision by EPA political
appointees to deal with the attacks on IRIS by hosting numerous
stakeholder engagement events, some tied to specific
assessments, others related to broader science issues, or even
general concerns about the program as a whole. EPA's political
appointees seem to harbor the naiive idea that this process
will placate its critics. Instead, endless jawboning has left
the agency vulnerable to cynical exploitation.
In sum, let us not lose sight of what is really at stake,
the priceless notion that the water we drink and the air we
breathe ought to be clean and healthy. Thank you.
[The prepared statement of Ms. Steinzor follows:]
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Chairman Broun. Thank you, Ms. Steinzor. Mr. Walls, you are
recognized for five minutes.
TESTIMONY OF MR. MICHAEL P. WALLS,
VICE PRESIDENT OF REGULATORY AND TECHNICAL AFFAIRS,
AMERICAN CHEMISTRY COUNCIL
Mr. Walls. Good afternoon, Dr. Broun, Ranking Member
Bonamici, Chairman Schweikert, and the Members of the
Committee. We very much appreciate the opportunity to appear
here today to comment on progress in the IRIS program.
You can count me among the fans of Ken Olden. We would like
to compliment Ken for his leadership in the IRIS program. The
changes he has instituted since the NAS report in 2011 is--are
bringing IRIS closer to a high standard of public engagement,
transparency, and openness. We share his interest, and the
program's interest, in assuring that IRIS assessments can help
EPA and others do a better job of protecting health and the
environment.
We are concerned, however, that some of the policies and
practices in the program continue to perpetuate the development
of unrealistic overestimates of risk. These shortcomings can
have real, if unintended, consequences. And that is because the
risk management decisions that are made by federal and state
governments, for example, routinely draw upon the numbers
generated in assessment programs like the IRIS program.
Now, ACC recently released a set of principles that set out
attainable high level benchmarks for federal assessment
programs. Our principles focus on four areas, improvement in
assessment design, improvement in data and method integration
and review, how those assessments are communicated, and review
and accountability in those programs. Our principles are
consistent not only with the NAS reports, but are consistent as
well with the administration's own science integrity goals.
At this point in time, however, and I think as Dr. Olden
has noted, much work remains to be done to ensure those
benchmarks are achieved in the program. The 2011 report
identified significant scientific shortcomings in the program.
EPA, to its credit, is committed to fully implementing those
recommendations.
But now, three years after the 2011 report was released,
many of the most critical changes remain to be fully
implemented. In fact, materials released by the agency just
last week--in those materials released just last week, EPA
indicated that only two of the chemicals now in the IRIS
pipeline even have any chance of being fully consistent with
the 2011 recommendations, as well as the enhancements that Dr.
Olden himself has implemented. The NAS's 2014 report
acknowledged that progress has been made. It also reiterated
several of the same concerns noted in 2011, and made further
recommendations for improvement.
Now, in our view, the most critical area for IRIS reform is
evaluating and integrating scientific evidence in a transparent
and robust manner. For example, IRIS has identified study
quality considerations for certain scientific evidence, but the
assessments have not systematically and transparently evaluated
the studies against those considerations. NAS recommended that
in 2011, and did so again in 2014.
IRIS assessments needs to consistently address mode of
action. That is how the human body works, and the way the
chemicals interact with the body at different levels of
exposure. But EPA's approach, however, has left stakeholders
guessing about how mode of action and mechanistic information
will be used. If IRIS assessments are designed well from the
very beginning, the agency can organize the available
information to evaluate the plausible alternative hypotheses,
and they can do so in a much more timely way. They will be much
more productive at getting assessments completed. We think EPA
should also articulate a better standard for using data,
instead of default assumptions, as well as more effectively
addressing peer review.
Finally, how the agency characterizes and communicates this
information to the public is critically important. When
assumptions are used in lieu of data, the assumptions should be
disclosed, along with the justification for their use. The NAS
this year called on the EPA to develop guidelines for
uncertainty analysis and communication. The IRIS assessments
themselves should provide a complete picture of what is known
and what is inferred.
But just this past Monday, at a meeting of the chemical
assessment advisory committee, in their review of the ammonia
assessment, it demonstrated that the panel itself couldn't
figure out why EPA--how EPA chose some numbers, and why they
did that. So we are looking forward to continuing our work with
your Committee, with Dr. Olden, and other stakeholders to make
sure that the NAS recommendations, as well as the principles we
have articulated are implemented in the program.
We hope, in fact, that other EPA program offices, and other
federal agencies, will carefully consider the recommendations
by the NAS to make appropriate improvements in their own
programs. We share a mutual interest in ensuring that high
quality information is applied to make better, more timely
public health decisions. Thank you.
[The prepared statement of Mr. Walls follows:]
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Chairman Broun. Thank you, Mr. Walls. We have been informed
that we are going to start having votes at about 2:10, about a
minute or a minute and a half from now, and it is going to be
long series. So, to try to expedite things, and get to as many
Members as we possibly can, the minority and I have agreed that
we are going to limit each Member to three minutes so that we
can try to get through as many Members as possible. We will
offer you all the opportunity to answer questions, and their
questions for the record, QFRs, as we normally call them, so
please be expeditious in giving those back to us. Thank you all
for your testimony. I will open the first round of questions
now, and I recognize myself for three minutes.
Dr. Olden, as I mentioned in my statement, I appreciate all
of your efforts to reform the IRIS program, including your
attempts to increase transparency and stakeholder input. I do
wonder, however, when will this process be completed, and when
will the EPA publish its first IRIS assessment that will
reflect all of the recommendations and suggestions offered by
NRC to substantially improve the program?
And then, furthermore, do you anticipate the first couple
of IRIS assessments that will incorporate all of the NRC
recommendations to be on new chemicals, and if so, which ones
will be first, or will there be updates of old assessments, and
if so, which ones?
Dr. Olden. Chairman Broun, any chemical that was started
after the 2011 formaldehyde report will have all the
recommendations that were included in the formaldehyde NRC
committee report. So how many chemicals that is, I am not
absolutely certain. But I would say by--in three to five years
we will have completely implemented all the recommendations of
the NRC reports.
Chairman Broun. Are you talking about three to five years
from now, or when you began the process?
Dr. Olden. --three to five years from now.
Chairman Broun. Okay.
Dr. Olden. Right.
Chairman Broun. Are new chemicals involved in the
assessment, or are you just going to do old ones? And which
ones are you going to test?
Dr. Olden. There are new chemicals in the pipeline that
will be involved in the assessment. And there are probably some
old ones. I can get back to you with the specifics. But there
will be both new, and possibly some old chemicals.
Chairman Broun. Okay.
Chairman Broun. Can you give us a number?
Dr. Olden. What we are doing now is doing a strategic--long
term strategic planning to identify the needs of the agency.
And once we get--so we send a survey out to all the program
directors and regional directors, and we are getting that
information back. When we assemble that information, we will
make--know which chemicals the agency needs, and we will make
assessment of those chemicals our highest priority.
Chairman Broun. Thank you, Dr. Olden. Ms. Bonamici, you are
recognized for three minutes.
Ms. Bonamici. Thank you very much, Mr. Chairman.
Ms. Steinzor, you mentioned in your testimony some of the
health effects of chemicals for which IRIS has provided
scientific documentation, for example--or scientific
determinations, excuse me, brain damage, cardiovascular
illness, reproductive dysfunction, cancer. That is a list that
should cause us to pay attention, and I want to bring up
something that you mentioned in your written testimony, the
January 2014 chemical spill in West Virginia. As you indicated
in your testimony at the time of the spill, the chemical being
used, called Crude MCHM, was not in the IRIS database.
So, briefly, and then I will ask you to expand in writing,
under the current IRIS and EPA process, what would have to
happen before a chemical like MCHM would be subject to an IRIS
assessment?
Ms. Steinzor. Well, the problem with that chemical is it is
not listed in any of the statutes, such as the Clean Air Act or
the Safe Drinking Water Act, as being a contaminant of concern,
and yet we saw that it caused very grave problems in West
Virginia. For it to make its way onto the IRIS list, and
actually have an assessment completed, our calculations are it
would take decades at the rate they are going, and that is very
unfortunate.
As you know, the people there have been told that they need
to make a personal decision about whether to shower, or bathe
their babies in the water.
Ms. Bonamici. And I am going to try to get a couple more
questions in. Now, recently this Committee took up a bill
alleging secret science at the EPA. We hear a lot about the
need for transparency. Now, it is my understanding that the
companies do not have to demonstrate the safety of their
products. And, in fact, safety data is often treated as
proprietary. So we all know that we need chemicals for modern
society, but how can we be confident that the chemicals in the
marketplace are not harming us?
Ms. Steinzor. I don't think we can be confident, as the
West Virginia example shows, and I would urge you to take a
very careful look at that bill. That bill would make it even
more difficult for EPA to assess chemicals by raising the
burden of what kind of evidence they have to have, in lieu of a
testing requirement, very high.
Mr. Walls. Ms. Bonamici, may I make a comment quickly on
that?
Ms. Bonamici. Well, I only have 41 seconds. For the record,
please do submit.
Dr. Dorman, thank you for the Academy--for all your work
that you have done. Can you tell me when the Academy's work
will be completed, and at what point will you be finished with
changing the process, or contributing to the process?
Dr. Dorman. So with respect to the report that was issued
in May, I mean, that is a project that has been completed. One
of the things to keep in mind is that the Academy's activities,
having been a member of several committees now, have largely
been directed by either Congress, mandated by Congress, or else
requested by EPA. And so, really, a lot of the work that the
Academies is doing with respect to the IRIS program is being
driven by those factors.
Ms. Bonamici. And do you still have productive
contributions to make?
Dr. Dorman. So right now to my knowledge, the Academies--
the only IRIS process--one that we are looking at right now, or
the Academies is looking at, is related to arsenic.
Ms. Bonamici. Thank you. I am out of time, and, Dr. Olden,
I will be submitting more questions for the record. I yield
back----
Chairman Broun. Thank you, Ms. Bonamici.
Chairman Schweikert, you are recognized for three minutes.
Mr. Schweikert. Thank you, Mr. Chairman. It feels sort of
like the lightning round. As Ms. Bonamici touched on, one of
the benefits, obviously, of the Secret Science Bill is if EPA
uses industry data, it has to become public. The baseline data
sets become public. So I am hoping that actually sort of
provides a benefit for everyone.
Mr. Dorman, I have one concern, and let us see if I can
articulate this quickly. A standard parts per million is
created in this process. Don't we have OSHA, CDC, even other
parts of EPA, and then on occasion I will see European
standards, as well as others. Are we in a world right now where
we have lots and lots of different benchmarks being offered? Is
there a need to start trying to do a consolidation of what is
the standard of health attributes? And then--first that one,
then there is an auxiliary to that.
Dr. Dorman. So you raise a great point. There are a number
of different agencies charged by individual companies, or
countries, to try to come up with different types of exposure
standards, for example, Health Canada versus EPA, and sometimes
there are divergent numbers that are developed both within the
United States and elsewhere. A lot of that depends upon what
the populations at risk sometimes represent. So, for example,
if OSHA is creating a standard for workers, that standard may
be very different than what EPA is required to do for the
general population.
But the methodologies--I think one of the things that our
committee was stressing is that in any case, what EPA--when
they are developing those numbers, try to be as transparent as
possible so people can look at how those numbers were actually
developed.
Mr. Schweikert. Okay. Mr. Dorman, so, if we knew all these
different regulators that are publishing data on different
chemicals are following a standardized methodology for
analysis----
Dr. Dorman. Right.
Mr. Schweikert.----, then there is the next part of that.
Instead of saying, here is my benchmark, it is blank parts per
million, shouldn't it be blank parts per million when handled
in this fashion? In this fashion, you might have other types of
mitigation. Are we also doing a good enough job providing those
other levels a definition of it also has to do with
environment, being used in industry, mechanics, the other
attributes around it?
Dr. Dorman. Right. So, very quickly, again, it comes back
to--for example, on the OSHA numbers, those oftentimes will
look at personal protection, which was--not be available to the
general population, which EPA is now viewing for, say, the RFC
or RFD values. So these numbers that EPA is developing are for
unprotected populations at risk.
Mr. Schweikert. Okay. And, Mr. Chairman, I promise all of
you I will have some questions in writing. I have a sort of a
fixation on data, whether you think it helps you or hurts you,
becoming public, because I think we need to also trust the kids
at a university, a left wing group, a right wing group, from
being able to have opportunities to analyze data, and compare
with other data sets. With that, I yield back, Mr. Chairman.
Chairman Broun. Thank you, Mr. Schweikert. Ms. Clark, you
are recognized for three minutes.
Ms. Clark. Thank you, Mr. Chairman.
Dr. Dorman, when Dr. Samet testified before this Committee
on the 2011 formaldehyde report, he made it very clear that the
NAS panel was not calling for the EPA to suspend IRIS
assessments, and was not saying that they could not do quality,
solid assessments. Instead, was recommending reforms in the
process that could be implemented in parallel with continuing
IRIS assessments. Can you tell me, is that still the position
of the NAS panel?
Dr. Dorman. So I think that Dr. Samet's comments were
echoed in our recent IRIS report, and----
Ms. Clark. Um-hum.
Dr. Dorman. --the bottom line is that for EPA, when the
Committee was trying to look at the changes that EPA was
making, those were in progress. And so what we felt as a
committee, and felt strongly, was that implementation of
different attributes within the process may take different
periods of time in order to fully implement. And so we
recognize that, both in the formaldehyde report that I served
on, as well as the IRIS committee.
And so I think the bottom line was neither committee had
the anticipation that we would see full cloth changes, but
rather we were seeing a progress that was occurring, that we
could then judge to see where they were going.
Ms. Clark. And in both the new report, and in your
testimony, it was found there were substantial improvement in
EPA's process, in line with those recommendations from 2011. Do
you see any evidence that EPA is producing what some have
called flawed assessments?
Dr. Dorman. So I think it is important that we were charged
with looking at the process, rather than any individual
assessments, per se. So we weren't asked to do any independent
assessments, or reviews of assessments, but what we did see was
a pattern on the part of EPA in which they were very
proactively implementing the changes in the formaldehyde. And
what we see is, once these are all fully implemented, we
believe that the quality of the assessments will actually
improve dramatically.
Ms. Clark. Thank you.
Mr. Walls, in your testimony you talked--referred a few
times to timely manner of these assessments. Do you believe the
IRIS program is completing assessments in a timely manner?
Mr. Walls. Congresswoman Clark, I think our view would be
that IRIS can do a better job, and, if it systemically
implements the recommendations made by the NAS, for example,
can get to a steady state stage, where they can regularly and
confidently produce these assessments.
Ms. Clark. Would the industry support additional resources
to make this happen for IRIS?
Mr. Walls. We have made clear our support for the agency
having appropriate resources to do this work.
Ms. Clark. Thank you.
Chairman Broun. Thank you, Ms. Clark.
Mr. Swalwell, you are recognized for three minutes. And
please be quick, because I would like to get to Ms. Edwards, if
we can, before--and give her a chance too. So you are
recognized for----
Mr. Swalwell. I will, and I have just one question for
Professor Steinzor, and I am a former University of Maryland
School of Law student, so I am thrilled----
Ms. Steinzor. Fantastic.
Mr. Swalwell. --you are there. Professor Steinzor, you
acknowledged in your testimony that the science of risk is
always evolving, yet the Academies have suggested, in their
recent report, that EPA adopt firm stopping rules for key
points in the IRIS process. Although it may appear obvious to
most, could you elaborate on the need for EPA to incorporate
stopping rules into the IRIS process, and how would a lack of
stopping rules impact the IRIS process?
Ms. Steinzor. So a stopping rule would be, we are going to
look at this information that is available as of this point. We
are going to apply a weight of the evidence analysis to it. We
are going to write an IRIS profile, and then we are going to
put the profile out. And if there are subsequent studies, we
will take a look at those, and revise the profile as
appropriate, on a cycle of five years, as an example, which is
what applies to national ambient air quality standards, and it
has worked fairly well.
Mr. Swalwell. Thank you. Go Terps, and I yield back the
balance of my time.
Ms. Steinzor. Fear the Turtle.
Dr. Olden. May I add to that? We have, in fact, developed
firm stopping rules in our enhancements that we rolled out
about last summer, in July. There are firm stopping rules
today.
Thank you.
Chairman Broun. Very good. Thank you, Dr. Olden. Ms.
Edwards, you are recognized for a very quick three minutes,
please, ma'am.
Ms. Edwards. Thank you very much, Mr. Chairman, and I will
be quick. My question is for Mr. Walls. You represent the
American Chemical Council. Is it true that the council spent
about $2.9 million in lobbying expenses over this last year, in
2014?
Mr. Walls. I would assume that is correct.
Ms. Edwards. And then in 2013 you spent about $13 million
in lobbying expenses?
Mr. Walls. I don't have those figures in front of me, but
we do make lobbying expenditures, yes, ma'am.
Ms. Edwards. And I just want to be clear. So my
understanding is that the council has opposed the assessment
for formaldehyde, opposed the assessment coming forward for
arsenic, opposed the assessment coming forward for
trichloroethylene, TCE, that is present in our drinking water.
Is there an assessment that you all support the EPA moving
forward on?
Mr. Walls. Congresswoman, our interest is ensure that the
best, highest quality, most reliable science is brought forward
to make those decisions.
Ms. Edwards. Right. What is the----
Mr. Walls. The regulatory----
Ms. Edwards. --last assessment that you--what is the last
assessment that you supported the EPA moving forward on?
Mr. Walls. We----
Ms. Edwards. Give me one.
Mr. Walls. We give--we support a number of assessments.
There is--EPA, for example, has a work plan chemical assessment
program in the Office of Pollution Prevention and Toxics, and
we have been clear that we support the agency's moving forward.
Ms. Edwards. Have you supported the agency moving forward
on the arsenic assessment?
Mr. Walls. Congresswoman, we have made clear that our
interest is in----
Ms. Edwards. Have you supported the EPA moving forward----
Mr. Walls. To date----
Ms. Edwards. --on the arsenic assessment?
Mr. Walls. We support moving forward on assessments in a
way that is----
Ms. Edwards. Have you supported the EPA moving forward on
the arsenic assessment?
Mr. Walls. I----
Ms. Edwards. Have you supported the EPA moving forward on
the formaldehyde assessment?
Mr. Walls. We have supported the agency moving forward on
IRIS assessments, but to do so in a manner that----
Ms. Edwards. Have you--I just want a yes or no, if you
could. Have you supported the----
Mr. Walls. I can't----
Ms. Edwards. --EPA moving----
Mr. Walls. I can't----
Ms. Edwards. --forward on the----
Mr. Walls. --a yes or no----
Ms. Edwards. --formaldehyde assessment?
Mr. Walls. --Congresswoman.
Ms. Edwards. No?
Mr. Walls. We have supported moving forward on the
assessment in a way----
Ms. Edwards. On the formaldehyde assessment?
Mr. Walls. In a way that----
Ms. Edwards. Support----
Mr. Walls. --reflects the----
Ms. Edwards. --the EPA----
Mr. Walls. --recommendations made----
Ms. Edwards. --moving forward on the----
Mr. Walls. --by the----
Ms. Edwards. --formaldehyde assessment? Did you--did the
American Chemistry Council have anything at all to do, or spend
any lobbying expenses, on ensuring that the EPA could not move
forward, and this Congress could not move forward, on the
arsenic assessment? Did you all lobby on that issue at all----
Mr. Walls. I----
Ms. Edwards. --in the Congress?
Mr. Walls. I don't have direct knowledge of that, but I
assume we did, yes.
Ms. Edwards. I will be following up with additional
questions.
Mr. Walls. I will look forward----
Ms. Edwards. Thank you very----
Mr. Walls. --to your questions.
Ms. Edwards. --much to the witnesses.
Chairman Broun. Thank you, Ms. Edwards. Apologize for the
fast round of questions. We have two more minutes in this vote,
so we are going to submit questions for the record, and you can
answer them. You can put a lot more flesh on these. Thank you
for your flexibility. And, again, I apologize for the hasty
period of time. I thank Members for you all's flexibility. The
record will remain open for two weeks for additional comments
and written questions from Members. The witnesses are now
excused. This hearing is adjourned, and thank you all.
[Whereupon, at 2:27 p.m., the Subcommittees were
adjourned.]
Appendix I
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Answers to Post-Hearing Questions
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Appendix II
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Additional Material for the Record
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Prepared Statement of Full Committeee Ranking Member
Eddie Bernice Johnson
Thank you Mr. Chairman. Virtually every aspect of our daily lives
is impacted by the use and presence of chemicals. The goal of the
Integrated Risk Information System (IRIS) at EPA is to provide
information to the American people about the risks associated with
exposure to certain chemicals. It should be obvious to anyone that
information about the health effects of chemical exposures can only
benefit the public. Unfortunately, the value of IRIS is too often
obscured by the criticisms of those who stand to gain by interfering
with EPA's mission to protect human health and the environment.
The National Academies report released this May praises the
substantial improvement made by EPA in addressing issues that had been
raised about the IRIS process. Specifically, the report states that if
EPA continues on this path of improvement, ``the IRIS process will
become much more effective and efficient in achieving its basic goal of
developing human-health assessments that can provide the scientific
foundation for ensuring that risks posed to public health by chemicals
are assessed and managed properly.'' The report also points out two
important future steps which EPA can take to further improve the
quality of their IRIS assessments.
First, EPA must continue to expand opportunities for stakeholder
input and discussion. The chemical industry is not the only stakeholder
in public health assessments. Community groups and public health
organizations do not always have the same resources to support
meaningful participation in the public processes of IRIS. The EPA must
not permit a privileged few to monopolize a process meant to foster
open discussion.
Second, EPA should be diligent in developing firm ``stopping
rules,'' that guard against undue delay in releasing its assessments.
Hundreds of new chemicals are released onto the market every year with
no requirement that their safety be demonstrated. IRIS was created to
address this lack of information on the potential toxicity of these
chemicals and their influence on human health.
Unfortunately, the pace at which IRIS finalizes its assessments has
slowed to an unacceptable rate. It is time EPA moves ahead with urgency
to bridge this gap and fulfill its mission. I am looking forward to
hearing from Dr. Olden on this matter.
It is clear that IRIS provides a valuable service to the American
people. We must encourage EPA to be diligent in its efforts for
continued improvement, and support them as they implement the
recommendations of the National Academies.
Thank you, and I yield back.
[all]