[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]

CHEMICAL RISK ASSESSMENT: WHAT WORKS FOR JOBS AND THE ECONOMY?

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

HEARING

BEFORE THE

SUBCOMMITTEE ON ENVIRONMENT AND THE ECONOMY

OF THE

COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES

ONE HUNDRED TWELFTH CONGRESS

FIRST SESSION

__________

OCTOBER 6, 2011

__________

Serial No. 112-93

Printed for the use of the Committee on Energy and Commerce

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COMMITTEE ON ENERGY AND COMMERCE

FRED UPTON, Michigan
Chairman

JOE BARTON, Texas HENRY A. WAXMAN, California
Chairman Emeritus Ranking Member
CLIFF STEARNS, Florida JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania EDOLPHUS TOWNS, New York
MARY BONO MACK, California FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska ANNA G. ESHOO, California
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
SUE WILKINS MYRICK, North Carolina GENE GREEN, Texas
Vice Chairman DIANA DeGETTE, Colorado
JOHN SULLIVAN, Oklahoma LOIS CAPPS, California
TIM MURPHY, Pennsylvania MICHAEL F. DOYLE, Pennsylvania
MICHAEL C. BURGESS, Texas JANICE D. SCHAKOWSKY, Illinois
MARSHA BLACKBURN, Tennessee CHARLES A. GONZALEZ, Texas
BRIAN P. BILBRAY, California JAY INSLEE, Washington
CHARLES F. BASS, New Hampshire TAMMY BALDWIN, Wisconsin
PHIL GINGREY, Georgia MIKE ROSS, Arkansas
STEVE SCALISE, Louisiana JIM MATHESON, Utah
ROBERT E. LATTA, Ohio G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington JOHN BARROW, Georgia
GREGG HARPER, Mississippi DORIS O. MATSUI, California
LEONARD LANCE, New Jersey DONNA M. CHRISTENSEN, Virgin
BILL CASSIDY, Louisiana Islands
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas
DAVID B. McKINLEY, West Virginia
CORY GARDNER, Colorado
MIKE POMPEO, Kansas
ADAM KINZINGER, Illinois
H. MORGAN GRIFFITH, Virginia

7_____

Subcommittee on Environment and the Economy

JOHN SHIMKUS, Illinois
Chairman
TIM MURPHY, Pennsylvania GENE GREEN, Texas
Vice Chairman Ranking Member
ED WHITFIELD, Kentucky TAMMY BALDWIN, Wisconsin
JOSEPH R. PITTS, Pennsylvania G.K. BUTTERFIELD, North Carolina
MARY BONO MACK, California JOHN BARROW, Georgia
JOHN SULLIVAN, Oklahoma DORIS O. MATSUI, California
CHARLES F. BASS, New Hampshire FRANK PALLONE, Jr., New Jersey
ROBERT E. LATTA, Ohio DIANA DeGETTE, Colorado
CATHY McMORRIS RODGERS, Washington LOIS CAPPS, California
GREGG HARPER, Mississippi JOHN D. DINGELL, Michigan
BILL CASSIDY, Louisiana HENRY A. WAXMAN, California (ex
CORY GARDNER, Colorado officio)
JOE BARTON, Texas
FRED UPTON, Michigan (ex officio)

(ii)

C O N T E N T S

----------
Page
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 1
Prepared statement........................................... 3
Hon. Gene Green, a Representative in Congress from the State of
Texas, opening statement....................................... 5
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement...................................... 141
Hon. Mary Bono Mack, a Representative in Congress from the State
of California, prepared statement.............................. 144

Witnesses

Paul Anastas, Assistant Administrator, Office of Research and
Development, Environmental Protection Agency................... 6
Prepared statement........................................... 9
Answers to submitted questions............................... 151
David C. Trimble, Director, Natural Resources and Environment,
Government Accountability Office............................... 16
Prepared statement........................................... 18
Answers to submitted questions............................... 163
David C. Dorman, Dean for Research and Graduate Studies, North
Carolina State University, on behalf of the National Academy of
Sciences....................................................... 28
Prepared statement........................................... 30
Michael Honeycutt, Director of Toxicology Division, Texas
Commission on Environmental Quality............................ 57
Prepared statement........................................... 60
Answers to submitted questions............................... 166
Harvey Clewell, Director, Center for Human Health Assessment, The
Hamner Institutes for Health Sciences.......................... 100
Prepared statement........................................... 102
Answers to submitted questions............................... 175
Jerry A. Cook, Technical Director, Chemical Products Corporation. 105
Prepared statement........................................... 107
Answers to submitted questions............................... 179
Thomas A. Burke, Associate Dean for Public Health Practice and
Training, Department of Health Policy and Management, The Johns
Hopkins Bloomberg School of Public Health...................... 120
Prepared statement........................................... 122
Answers to submitted questions............................... 198

Submitted Material

Letter, dated September 1, 2011, from Sunil Widge, Chairman,
Specialty Steel Industry of North America, to Lisa Jackson,
Administrator, Environmental Protection Agency, submitted by
Mr. Murphy..................................................... 48
Letter, dated October 4, 2011, from Cal Dooley, President and
CEO, American Chemistry Council, to subcommittee leadership,
submitted by Mr. Shimkus....................................... 55
Majority memorandum, dated October 4, 2011, submitted by Mr.
Shimkus........................................................ 145

CHEMICAL RISK ASSESSMENT: WHAT WORKS FOR JOBS AND THE ECONOMY?

----------

THURSDAY, OCTOBER 6, 2011

House of Representatives,
Subcommittee on Environment and the Economy,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 9:07 a.m., in
room 2123 of the Rayburn House Office Building, Hon. John
Shimkus (chairman of the subcommittee) presiding.
Members present: Representatives Shimkus, Murphy, Pitts,
Bass, Harper, Cassidy, Gardner, Barton, Green, Butterfield,
Barrow, and DeGette.
Staff present: Caroline Basile, Staff Assistant; Anita
Bradley, Senior Policy Advisor to Chairman Emeritus; Jerry
Couri, Senior Environmental Policy Advisor, Environment; Dave
McCarthy, Chief Counsel, Environment/Economy; Carly McWilliams,
Legislative Clerk; Tina Richards, Counsel, Environment/Economy;
Chris Sarley, Policy Coordinator, Environment/Economy; Brett
Scott, Staff Assistant; Lyn Walker, Coordinator, Admin/Human
Resources; Tom Wilbur, Staff Assistant; Alex Yergin,
Legislative Clerk; Jacqueline Cohen, Democratic Counsel; and
Billie McGrane, Democratic Assistant Clerk.
Mr. Shimkus. The hearing will come to order. We want to
welcome the first and second panels, and I will start with my
first opening statement. And I recognize myself for 5 minutes.

OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS

It has been no secret to anyone following our Committee
that we have been taking a very specific look at the regulatory
climate in this country where it is imbalanced and unworkable.
In doing so, I and others have been clear that while we
advocate the maintenance of commonsense environmental and
public health protections, we also need to be careful about the
impacts of government encroachment and that these efforts not
discourage job protection and economic growth. Today's hearing
is another step to appreciate these issues.
To understand the final regulatory product and the economic
impacts of EPA activities, I think it is important to
appreciate the process used by the Agency to get those results.
Our hearing will delve into one of the foundational parts of
EPA's activities: the work of the Integrated Risk Information
System, also known as IRIS.
I have been a strong advocate for high-quality science that
is objective and valid. Moreover, I understand that many are
concerned about IRIS's activities on specific chemicals. I am
not here to defend any particular chemical. This hearing is not
about specific chemicals. To truly protect the public from harm
and negative economic outcomes, we need an unbiased process
informing policymakers about the science, not policymakers
informing the science.
IRIS was created over 25 years ago to provide EPA with
information to develop policy surrounding human health effects
from exposure to chemicals. There is no doubt providing such
high-quality science-based assessment is critical to EPA's
mission. The question is whether IRIS is in fact fulfilling
this goal, or have results begun to develop to support specific
policy objectives?
From our subcommittee's perspective, we need to grasp that
IRIS is the program making scientific assessments about
chemical substances that EPA program offices use to set federal
limits for various environmental laws, including the Safe
Drinking Water Act and the Solid Waste Disposal Act. In
addition, many states rely on IRIS data for their own
environmental program purposes.
We are honored today to have a collection of very
distinguished witnesses and I appreciate the time and
sacrifices they have made to be with us. Among the testimony we
will receive is from the administration and their view of IRIS
and its role. I look forward to getting an update on EPA's 2009
reforms to IRIS, as well as where things stand with the Chapter
7, the long-term recommendations of the National Academies of
Science for IRIS.
In addition, we will have insight on whether IRIS
assessments are doing what they should, if states are finding
IRIS work reliable, how much we should care about IRIS
assessment impacts on jobs and the economy, and is there a
better way for EPA to perform these assessments? These
recommendations could be helpful as we think about more global
issues affecting the EPA.
I hope all members will use this opportunity to understand
the process, discuss the integrity of the basic science
assessed at EPA, and appreciate how and when policy
considerations converge in this process and their impact on
jobs and the economy.
And I will now yield back my time and recognize the ranking
member, Mr. Green, for 5 minutes.
[The prepared statement of Mr. Shimkus follows:]

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OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF TEXAS

Mr. Green. Thank you, Mr. Chairman. I thank you for holding
this hearing today entitled ``Chemical Risk Assessment: What
Works for Jobs in the Economy?''
Risk assessment is a critical component in the protection
of public health and the environment. Without adequate risk
assessment, legislators and regulators cannot make informed and
wise decisions about risk management. EPA has the
responsibility to manage the Integrated Risk Information
System, or IRIS, to inform the public, industry, and
policymakers with the strongest and best-available science on a
variety of potentially hazardous materials in the most non-
political manner.
In 1985, they established IRIS to help the Agency develop
consensus opinions within the Agency about the health effects
from the chronic exposure to chemicals. Currently, the EPA has
assessments of 550 chemicals. These assessments are utilized by
the EPA to further their mission and to set standards to
protect human health and environment. IRIS assessments can be
used in regulations that garner a lot of attention. In recent
years, this attention has not been positive.
In 2008, the Energy and Commerce Committee held a hearing
in the Oversight and Investigations Subcommittee on IRIS and a
GAO report that exposed concerns about the IRIS program. At the
hearing, the GAO testified that there was a backlog of 70
chemicals in the IRIS system that needed to be completed but
that only four had been completed in 2008. And half the 540
chemicals that were currently in IRIS possibly had outdated
risk assessments. On tops of that, there are hundreds of other
chemicals that have been referred to the IRIS system but have
not even begun the assessment process. I also note that since
the hearing in 2008, IRIS has only released assessments on 10
additional chemicals.
In that 2008 hearing, I expressed concern regarding the
IRIS assessment of dioxin. If you look at the dioxin section on
IRIS webpage, you see a timeline. It appears that IRIS has been
assessing dioxin since 1985. I asked questions about this
assessment in 2008, and now 3 years later, EPA released a
statement that IRIS's assessment on dioxin will be finalized in
2012.
Dioxin is a compound that we know is very dangerous and far
too prevalent in and around the district I represent along the
Houston Ship Channel. Just outside our district, we have the
San Jacinto Waste Pits Superfund site which consisted of
submerged waste pits from an old paper mill that were recently
discovered to be leaching high levels of dioxin in the San
Jacinto River and there into the Galveston Bay. Fish advisories
have been extended to larger and larger areas, creating a
threat both to the people who fish for food and for the large
port fishing industry in the area.
Dioxin status as a toxic compound should not be
controversial, so the fact that it has still taken an
additional 3 or 4 years for IRIS to complete its risk
assessment is very discouraging. If the EPA wants IRIS's
assessments to be viewed as legitimately scientific and
reliable, they must take steps to streamline their reviewing
process to issue assessments in a timely manner so they are not
outdated or make the assessments clearer and easier to
understand.
The National Academy of Sciences issued guidance on how to
improve IRIS assessments, and I hope the EPA witness can update
the committee on the improvements being made in the IRIS
program and what they intend to do in the future to correct the
problems within the program. We need to restore the public
confidence in EPA's risk assessment and chemical regulatory
system and the first step must be to ensure the integrity of
EPA's scientific information and practices.
I look forward to hearing the testimony of all of our
witnesses, but particularly Dr. Honeycutt from TCEQ who is from
my home State of Texas and we work with them particularly on
that dioxin facility in the San Jacinto area.
And Mr. Chairman, I yield back my time.
Mr. Shimkus. The gentleman yields back his time.
Does the gentleman from Mississippi seek time for an
opening statement? Gentleman from Louisiana? Having no other
members present to seek time, I would like to welcome the first
panel.
First of all, let me introduce the entire panel, and then
we will go to 5-minute opening statements.
First we have Dr. Paul Anastas, the Assistant Administrator
to the Office of Research and Development in the United States
Environmental Protection Agency. Sir, welcome. Also, Mr. David
Trimble, Director of Natural Resources and Environment for the
U.S. Government Accountability Office; and Mr. David C. Dorman,
Dean for Research and Graduate Studies at North Carolina State
University on behalf of the National Academy of Sciences.
We have two great panels and we again welcome you. And I
would like to first turn to Dr. Anastas from the EPA for a 5-
minute opening statement. We have got a lot of members. We have
got time if you go over. That is not a problem. If it goes too
far, then it might be a problem.
So welcome and you are recognized, sir.

STATEMENTS OF PAUL ANASTAS, ASSISTANT ADMINISTRATOR, OFFICE OF
RESEARCH AND DEVELOPMENT, ENVIRONMENTAL PROTECTION AGENCY;
DAVID C. TRIMBLE, DIRECTOR, NATURAL RESOURCES AND ENVIRONMENT,
GOVERNMENT ACCOUNTABILITY OFFICE; AND DAVID C. DORMAN, DEAN FOR
RESEARCH AND GRADUATE STUDIES, NORTH CAROLINA UNIVERSITY, ON
BEHALF OF THE NATIONAL ACADEMY OF SCIENCES

STATEMENT OF PAUL ANASTAS

Mr. Anastas. Good morning, Chairman Shimkus, Ranking Member
Greene and other members of the Committee. My name is Paul
Anastas and I am the assistant administrator for the Office of
Research and Development at the Environmental Protection Agency
and the Agency's science advisor. Thank you for the opportunity
to be with you here this morning to discuss the Integrated Risk
Information System, also known as IRIS.
At the EPA, we firmly believe that the American people
deserve the best possible scientific information about the
chemicals that they may encounter in their air, water, and
land. When those chemicals may potentially affect their health,
their children, and the health of their communities, we have
the duty to vigorously study them and share what we know with
our citizens.
Every day, expert scientists in EPA's IRIS program work to
fulfill that duty providing this information by drawing upon
the best science both from the Agency as well as from
universities and research institutes around the world. The
assessments that we develop as part of the IRIS program are
scientific documents, not regulations. This is an important
distinction. While the information they contain is useful in
our agency decisions, it is also widely used by communities,
businesses, environmental groups, and public citizens. For
those reasons and more, we recognize the importance of
maintaining the highest level of scientific integrity when
generating these IRIS assessments. That is why every draft IRIS
assessment is made available to the public, to our sister
federal agencies, and to the broader scientific community for
their review and comment.
The draft assessments we produce undergo one of the most
rigorous, independent peer review processes in any scientific
field. This peer review process makes our IRIS assessments
stronger. The comments that we receive are valued and
addressed. This is precisely why we undergo such rigorous
review. This is how the scientific process works.
We also recognized that continuous improvement is what
science is all about. That is why in May 2009, Administrator
Jackson put into place a strengthened and streamlined IRIS
process. This new process not only strengthened the scientific
integrity of the IRIS program, it also shortened the average
time frame for generation of IRIS assessments from 5 years to
just 23 months. Since 2009, EPA has completed 20 IRIS
assessments, twice as many assessments as were finalized in the
previous 4 years combined.
But our efforts to continuously improve didn't stop there.
This past July, I announced a plan to further strengthen the
IRIS program. Because our assessments are widely used in the
decisions of state and local governments, businesses, and
American citizens, we have focused on making them clearer, more
concise, and ensuring that our methods and scientific
assumptions are more transparent to the users. These
improvements, which we began aggressively implementing in July,
directly address the suggestions from the National Academy of
Sciences and other independent experts. The NAS made six major
suggestions to improve the generation of IRIS documents, and we
are implementing all of those recommendations. Those
recommendations and how we are dealing with them are detailed
in my written testimony, and I will be happy to expand on
those.
We will pursue continuous improvement, but we will proceed
in a way that does not slow or prevent our ability to provide
the best scientific information to the public. That is what the
American people expect and deserve. We recognize that the only
reason to deeply understand a problem is to inform and empower
its solution. When we look at the information that is being
transmitted through our IRIS assessments, information about
what makes a chemical hazardous, that information can be used
to design the next generation of chemicals so that they are not
hazardous in the first place. We believe this information
empowers innovation in the marketplace.
Leading companies understand this potential for innovation
and are pursuing it aggressively through the use of green
chemistry. Green chemistry is the design of chemical products
and processes that reduce or eliminate the use and generation
of hazardous substances. By understanding the properties that
make a chemical hazardous, scientists and industry and in
academia are meeting environmental and economical
simultaneously through the principles of green chemistry
design.
New life-saving medicines are being developed in ways that
produce dramatically less waste through green chemistry. New
high-performing materials are being invented to serve their
purpose and then degrade harmlessly into the environment
through green chemistry design. New products are being
introduced into the marketplace that are safe for children and
attractive to consumers through green chemistry. All of this
progress is being made in sectors ranging from agriculture to
energy, transportation to telecommunications, and cosmetics to
computing. Companies across the American economy are increasing
profits and enhancing competitiveness through green chemistry.
That is the power and the potential of green chemistry. And
that is why the lessons we learn from toxicology and the IRIS
program are important for feeding innovation.
In conclusion, whether it is through IRIS or our other
cutting-edge scientific research, EPA is providing critical
information to companies, entrepreneurs, and researchers so
they can make new discoveries and develop new innovations all
while protecting health and the environment. That is the real
power of understanding chemical hazard and that is why EPA's
IRIS program is so critically important.
We will continue to improve this program using the best
science not only to understand the problems of today, but to
inform and empower the solutions of tomorrow. It is what is
necessary for the environment, for public health, for the
economy, and I think we can all agree that it is what the
American people deserve.
Thank you for the opportunity to speak here this morning. I
will be happy to answer any questions as is appropriate.
[The prepared statement of Mr. Anastas follows:]

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Mr. Shimkus. Thank you, Dr. Anastas.
And we would now like to recognize Mr. David Trimble. Sir,
you are recognized for 5 minutes likewise. Take your time and
get through it, and we welcome you here.

STATEMENT OF DAVID C. TRIMBLE

Mr. Trimble. Chairman Shimkus, Ranking Member Green, and
members of the subcommittee, I am pleased to be here today to
discuss our prior work and recommendations on EPA's Integrated
Risk Information System.
As you know, the IRIS database contains EPA's scientific
position on the potential human health effects of exposure to
more than 550 chemicals in the environment. IRIS assessments
are a critical component of the EPA's capacity to support
scientifically sound risk management decisions, policies, and
regulations.
In March 2008, we reported that the IRIS program was at
serious risk of becoming obsolete because the Agency has not
been able to complete timely credible chemical assessments or
decrease its backlog of 70 ongoing assessments. We found that
the time frames for completing assessments were unacceptably
long, often taking over a decade. In many cases, assessments
became obsolete before they could be finalized and were stuck
in an endless loop of assessment and reassessment.
In April of 2008, EPA revised the IRIS process, but the
changes made were not responsive to our recommendations. The
new process was actually worse than the one it replaced,
institutionalizing process that resulted in frequent delays by
enabling OMB to determine when an IRIS assessment could move
forward. Further, this process effectively excluded the content
of OMB's comments to EPA and those from other interested
federal agencies from the public record.
Concerned with these programs and the Agency's lack of
responsiveness, we added EPA's process for assessing and
controlling toxic chemicals to our January 2009 report on
government-wide high-risk areas in need of an increased
attention by executive agencies and Congress. In May 2009, EPA
had made significant changes to the IRIS process. In June of
that year, we testified that these changes, if implemented and
managed effectively, would be largely responsive to the
recommendations we made in our March 2008 report. Let me
highlight three of these key changes.
First, the IRIS process would be managed by EPA rather than
OMB as the former process was, restoring independence to EPA.
Second, it required that all written comments provided by OMB
and other federal agencies and draft IRIS assessments be part
of the public record, adding transparency and credibility to
the process. Third, the procedures consolidated and eliminated
steps, streamlining the process.
Notably, the new process eliminated the step under which
other federal agencies could have IRIS assessments suspended
indefinitely to conduct additional research. As we have
reported, we understand that there may be exceptional
circumstances under which it may be appropriate to wait for the
results of an important ongoing study. However, as a general
rule, we believe that the IRIS assessments that are based on
the best available science is a standard that would best
support the goal of completing assessments within reasonable
time periods and minimizing the need to conduct wasteful
rework.
While the May 2009 IRIS process changes reflect a
significant improvement that can help EPA restore the integrity
and productivity of the IRIS program, EPA still faces
significant management challenges as it seeks to completely
timely, credible IRIS assessments.
First, EPA must continue to balance the need for using the
best available science with completing IRIS assessments in a
timely manner. As we have reported, even 1 delay can have a
domino effect requiring the process to essentially be repeated
to incorporate changing science.
Second, EPA faces long-standing difficulties in completing
assessments of chemicals of key concern, those that are both
widespread and likely to cause significant health issues. We
believe that EPA must continue to focus on the best available
science, obtaining credible expert review, and finalizing IRIS
assessments.
Third, EPA must be disciplined in keeping the timelines
even in the absence of fixed statutory deadlines for completing
IRIS assessments.
Lastly, we believe that to produce timely credible IRIS
assessments over a sustained period of time, it will be
important for EPA to maintain a consistent process going
forward.
We are currently reviewing EPA's implementation of its
revised 2009 IRIS assessment process and its response to our
previous recommendations. As part of this review, we will be
examining EPA's response to NAS's recommendations for
improvements to the IRIS process. We plan to issue this report
later this year.
That concludes the summary of my statement. I will be happy
to answer any questions any member of this committee may have.
[The prepared statement of Mr. Trimble follows:]

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Mr. Shimkus. Thank you very much.
Now, I would like to recognize for 5 minutes Dr. David
Dorman, who is testifying on behalf of the National Academy of
Sciences. Sir, welcome. You have 5 minutes, and take your time
on the opening statement.

STATEMENT OF DAVID C. DORMAN

Mr. Dorman. Thank you. Good morning, Mr. Chairman and
members of the subcommittee. My name is David Dorman. I am a
professor of toxicology at North Carolina State University and
I served on the National Research Council's Committee to Review
EPA's Draft IRIS Assessment of Formaldehyde.
The NRC report was developed by 15 scientists drawn by
academia, federal laboratories, state government, and other
organizations. The scientists that served on the NRC committee
were selected by the National Academies and had a wide array of
scientific expertise related to this effort. As part of the
Academy's process, a draft of the committee's report was
subjected to extensive peer review prior to release by the NRC.
It is important to note that the NRC was not asked to
conduct an independent assessment of formaldehyde but rather we
were charged with examining EPA's identification of potential
cancer and non-cancer health effects, the toxicological basis
for those health effects, and the way uncertainty factors used
to derive the reference concentrations and the quantified
cancer unit risk estimates for formaldehyde. The major findings
of our NRC committee were as follows:
First, we found that the U.S. EPA was faced with the
daunting task of compiling a complex and large toxicological
database for formaldehyde. For the most part, the committee
agreed that EPA achieved this goal. The EPA's draft assessment
for formaldehyde was prepared using the Agency's current format
and approach for IRIS documents. Our committee found the EPA's
document to be quite cumbersome and was too often lacking in
clarity and transparency. We were troubled that previous NRC
committees reviewing similar assessments for other chemicals
had identified similar deficiencies.
Third, our committee therefore offered a set of suggestions
for changes in the IRIS development process that might help EPA
improve its approach. In essence, we provided EPA with a
roadmap for changes in the development process. The term
roadmap was used because the topics that needed to be addressed
were set out, but detailed guidance was not provided by the
committee since that was seen as beyond our committee's charge.
Thus, the committee provided general guidance for the
overall process and some specific guidance on the specific
tests and steps of evidence identification, evidence review and
evaluation, weight-of-evidence evaluation, selection of studies
for derivation and calculation of reference concentrations and
unit risk. For each of these steps, there are underlying
processes that would need to be examined and reconsidered. The
NRC report provides further details on these recommendations.
Finally, the committee recognized that any revision of the
approach would involve an extensive effort by EPA staff and
others, and consequently, it did not recommend that EPA delay
the revision of the formaldehyde assessment while revisions of
the IRIS approach were undertaken. In fact, we provided
specific guidance as to the steps needed to revise the existing
draft IRIS assessment. Models for conducting IRIS assessments
more effectively and efficiently are available, and the
committee provided several examples in the present report.
Thus, EPA might be able to make changes in its process
relatively quickly by selecting and adapting existing
approaches as it moves towards a more state-of-art process.
As a member of the committee, I have been pleased to hear
that Dr. Anastas and other EPA administrators plan on
implementing suggestions found in the NRC formaldehyde report.
In closing, I would like to thank all of you for inviting
me here to discuss the NRC's report and I welcome your
questions.
[The prepared statement of Mr. Dorman follows:]

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Mr. Shimkus. Thank you very much. And we will start.
And I will recognize myself for 5 minutes for the first
round of questions.
First to Dr. Anastas, you have been clear in the past that
IRIS does not perform risk assessments; rather this is done by
risk managers in the program office, and I have been trying to
handle those differences. EPA's Web site, though, states that
IRIS is ``a human health assessment program that evaluates
quantitative and qualitative risk information on effects that
may result from exposure to specific chemical substances found
in the environment. If this is true, how can IRIS not be doing
``risk assessments'' if it has to distill qualitative risk
information and quantitative risk information?
Mr. Anastas. The elements of a full risk assessment have
been outlined in a landmark 1983 NAS report that looks at risk
identification and characterization, dose response as well as
exposure. What an IRIS assessment is today is looking at the
hazard identification and characterization and the dose
response. Until that information--which is powerful and
actually fundamental to a risk assessment--is combined with the
exposure models and the exposures that are expected and
anticipated under a regulatory program or some other scenario,
that is when it becomes a full risk assessment and is used in
risk management. This is the important but only the front-end
part of that overall calculus.
Mr. Shimkus. Thank you. You did answer this question in
your opening statement. I am just going to go through three
quick ones. You stated in your opening statement that the IRIS
office evaluates peer review recommendations, correct? Is that
what you said in your opening statement?
Mr. Anastas. Right. When we get any peer review comments,
we always review them and address them, yes.
Mr. Shimkus. Do you write draft assessments and evaluate
public comments?
Mr. Anastas. We submit our draft assessments for public
comment and the public and the scientific community comments on
those drafts.
Mr. Shimkus. Does your office decide what to include and
exclude and what other changes to be made to its own work based
upon those two responses?
Mr. Anastas. Through an extensive and iterative process, we
receive those comments, address those comments, and
transparently show how we have addressed those comments.
Mr. Shimkus. Thank you.
Mr. Trimble, what effect does IRIS risk values have on the
regulated community or the private marketplace?
Mr. Trimble. Well, as Dr. Anastas has indicated, it forms
the basis for many of EPA's regulatory decisions. For example,
in drinking water standards, the information in IRIS will be
married up with occurrence data whether or not the contaminant
has been found in water across the country to inform decisions
about whether or not, for example, to regulate a contaminant.
So it is the building block for many of EPA's regulatory
decisions.
Mr. Shimkus. But if the IRIS assessment is not finalized
for over a period, then what is that effect?
Mr. Trimble. Then basically everything comes to a
screeching halt because the mission teams like the water office
or air, they don't have sort of the basic science they need to
carry out their mission.
Mr. Shimkus. And then the private sector who might be
preparing for this are----
Mr. Trimble. Everyone is left hanging.
Mr. Shimkus. Thank you. And Dr. Dorman, I have talked about
this numerous times in my years here on the committee. What is
the value of a risk assessment value that identifies a level
below a natural occurring background level?
Mr. Dorman. So that is a dilemma for a number of chemicals
that exist endogenously, and my own opinion--and I think it
also was echoed in a report--is that for formaldehyde in
particular, those endogenous levels need to inform the
assessment as performed by EPA or other agencies. On a personal
note, kind of speaking not for the committee, I think that
becomes a challenge and I think that oftentimes we don't
regulate chemicals, we don't consider the risk assessment in
light of that endogenous background.
Mr. Shimkus. And endogenous meaning?
Mr. Dorman. That is what is present normally in the body
just from consumption of food or for metabolism. It is
basically what your body produces.
Mr. Shimkus. So in the numerous years I have been on this
committee and dealing with--you know, we have water issues that
would have endogenous elements in it, we have ground that has
endogenous elements, so I guess for the layman, having a
standard that is lower than naturally occurring, cleaning the
soil up and then you can't replace it with the same soil. This
same soil is still higher than the standard established by this
risk assessment, is that correct?
Mr. Dorman. Correct. That could be the case.
Mr. Shimkus. Thank you very much.
Now, I would like to recognize my colleague, Mr. Green, for
5 minutes.
Mr. Green. Thank you, Mr. Chairman.
And I guess why IRIS is so important--and I happen to
represent the largest petrochemical complex in the country--is
that all the chemicals used properly are something that we
really benefit from, but that is why IRIS is so important
because of those beneficiary uses, but in certain levels. And
the best example is formaldehyde and dioxin. We need those but
when used properly and that is why IRIS is so important to do.
Mr. Administrator, I mentioned in my opening statement I
was concerned with the length of time it has taken IRIS to
complete assessment of dioxin due to the presence of dioxin
super flight in our district. It is my understanding that IRIS
is expected to release a portion of the final dioxin assessment
in January of 2012. Is that correct? And can you elaborate very
briefly on why this is a two-part assessment? Yes, sir.
Mr. Anastas. One of the things that I did try to emphasize
is that when we receive comments on an assessment, we take them
extremely seriously and we want to fully address all of these
comments. We follow the science. The science is what dictates
when we can release a final assessment. We submitted the dioxin
assessment most recently the received comments on both the
cancer portion of the dioxin assessment and the non-cancer
portion of the assessment. It is clear that the comments on the
non-cancer portion of the assessment are things that can be
readily dealt with, addressed, and that we can move quickly
ahead.
The complexity of the dioxin cancer portion of the
assessment are far more complex and will not be completed on
the same time frame as the non-cancer portion of the
assessment. And that is based on the science and the complexity
of the science and the scientific issues.
Mr. Green. This is not the first hearing that our committee
has had on IRIS and it is an important program that has been
subject to review by the GAO and the National Academy of
Sciences Committee for years. It has been targeted because of
lengthy delays and because sometimes the politicalization--
surprise, surprise--in Washington what should be scientific
process. We saw this during the Bush Administration when the
OMB took over management of the IRIS program and the pace of
the assessments slowed to a crawl. The Government
Accountability evaluated the peer review process in 2004 and
raised certain concerns.
Mr. Trimble, can you briefly explain the concern GAO had
with IRIS review system that was in place from 2004 to 2008?
And again I am trying to remember. Obviously, OMB reviews all
regulations from agencies, but this is the first time I had
seen that OMB would actually control the process between
agencies for input. So I appreciate, you know, you answering
that.
Mr. Trimble. Briefly, what we found at the time was we had
concerns regarding productivity with the IRIS program, which we
have talked about. At that time one of the things that we noted
in our reports was that OMB had involved itself and taken
control of 2 key steps within the process so that reports and
IRIS assessments could now move forward without OMB's
concurrence. And that was I believe when reports were being
sent out for review and when they were being finalized.
So there was one aspect that dealt with productivity and
EPA's independent ability to control the process, but the other
aspect that we reported on that was troubling was that OMB's
involvement and comments were non-transparent so there was a
lack of transparency in the public regarding what changes were
being made and what those comments were. OMB brought in other
federal agencies and also those comments were not transparent
being deemed by OMB at the time as deliberative in nature. And
so it was those two factors that we reported on at the time.
Mr. Green. And again that is a different system than I
think we are used to, and there are times that as Members if we
lose at the Agency, whether the EPA or somewhere else, we will
go to OMB and talk about the economic impacts. And that is what
OMB should be doing----
Mr. Trimble. Um-hum.
Mr. Green [continuing]. And not getting involved in the
actual scientific assessment.
Dr. Dorman, I know you briefly described some of the
recommendations that National Science made. Can you talk about
particularly with the issue of formaldehyde?
Mr. Dorman. So I think in the case of formaldehyde, we
found largely that we had a number of areas in which we agreed
fully with the recommendations or the conclusions that the EPA
had in the IRIS document. We did have some areas in which we
differed as far as our interpretation of the EPA document in
light of the scientific evidence that is available. We did give
the Agency some specific recommendations regarding not relying
on certain studies. We felt they weren't the best studies
available for certain endpoints like sensory irritation and
others but hopefully that addresses your concern.
Mr. Green. OK, thank you. Thank you, panel.
Mr. Shimkus. The gentleman's time has expired.
The chair now recognizes the chairman emeritus, Mr. Barton,
for 5 minutes.
Mr. Barton. Thank you, Chairman Shimkus.
Let me ask Dr. Anastas. Are you career or you a political
appointee?
Mr. Anastas. I am a political appointee.
Mr. Barton. OK. And you have been in your position since
the Obama Administration took office?
Mr. Anastas. Shortly thereafter. Actually, it was January--
--
Mr. Barton. OK.
Mr. Anastas [continuing]. Of 2010.
Mr. Barton. Very good. I am going to ask you a little bit
different series of question in the hearing because my
interest, while I share some of the interest on chemical
issues, I am very involved in the air quality issue.
Does your office do any of the studies that relate to
ozone?
Mr. Anastas. We produce integrated scientific assessments
on a wide range of national ambient air quality standards,
including ozone.
Mr. Barton. OK. And mercury?
Mr. Anastas. Yes, all of those substances under the
program.
Mr. Barton. And PM2.5?
Mr. Anastas. Correct.
Mr. Barton. OK. Is there any other office within EPA that
does studies on those similar to your office?
Mr. Anastas. We work closely with our Office of Air and
Radiation and while we do the underlying scientific assessments
of the kind that we are discussing in IRIS and integrated
scientific assessments, the Office of Air and Radiation takes
those basic scientific documents into their regulatory process.
Mr. Barton. When the administrator is looking at tightening
the standards on the various criteria of pollutants under the
Clean Air Act, who make the decision whether the study to look
at the health effects is going to be done internally by your
office or externally?
Mr. Anastas. The process of generating a scientific
assessment on these chemicals would take place internally,
relying on a wide range of external studies--universities,
research institutes--and those assessments are conducted
internally and then put out for peer review.
Mr. Barton. Would there ever be an instance where your
office did not do an internal study, even if the decision was
made to do an external study?
Mr. Anastas. I am not familiar with a case where it would
be conducted completely externally. We rely on a wide range of
external studies to inform our assessments, but the assessments
that are fed into the regulatory process are constructed
internally.
Mr. Barton. Is it your decision whether to do the external
study or the administrator's decision or the deputy
administrator's decision or kind of a collective all of the
above?
Mr. Anastas. The conduct of the studies are dictated by the
needs of our regulatory and program offices and they work
closely with the Office of Research and Development to identify
which studies are necessary to inform their regulatory actions
and then we proceed. So that is the process that is used.
Mr. Barton. I don't necessarily understand that answer, but
I don't have but a minute and a half. So can you give me a
definition that is generally accepted of what a premature death
is?
Mr. Anastas. One would look at statistically a life
expectancy using epidemiological models and the absence of a
particular effect if you are looking at, for instance, a
respiratory----
Mr. Barton. Well, give me a layman's definition. I mean my
friends on the Democratic side, when we debate these
environmental bills where we are attempting to delay some of
the EPA regulation, they trot out these studies, and they are
usually 10 to 15 years old, they are usually external, and they
all seem to predict 30,000 premature deaths a year, but we have
never gotten a definition of what a premature death is.
Mr. Anastas. A premature death would be something that
shortens the otherwise----
Mr. Barton. I want to know what the definition is. Is a
premature death somebody who has a life expectancy of 80 who
dies at 40 because of exposure to ozone, dies at 50, dies at
35? I mean there should be some standard definition.
Apparently, there is not. Premature death is in the eyes of the
beholder.
Mr. Anastas. Their life expectancy would be shortened from
what it would otherwise be. So it is not set at a cutoff point
of how much shorter. That is----
Mr. Barton. Could you provide for the record a written
answer to what a premature death is?
Mr. Anastas. I would be happy to.
Mr. Barton. Whatever the definition is that your agency
uses, I would like to have it in writing.
Mr. Anastas. Certainly.
Mr. Barton. Thank you, sir.
Thank you, Mr. Chairman.
Mr. Shimkus. The chair now recognizes the gentleman from
Mississippi, Mr. Harper, for 5 minutes.
Mr. Harper. Thank you, Mr. Chair.
Dr. Anastas, just a question. Who selects who does the peer
review? Who is invited to join in that? Is that open? Tell me
how that works.
Mr. Anastas. Certainly. The peer reviews can be done, for
instance, by the National Academy of Sciences. They can be
conducted by our Science Advisory Board. They can be conducted
by panels of scientific experts. In the case of the National
Academies, they are selected certainly by the Academy. The
Science Advisory Board assembled ad hoc panels for those
reviews, and each of these types of processes is a vetting for
balancing different scientific expertise and ensuring that
there aren't ethical or conflicts of interest.
Mr. Harper. When a draft is prepared and done, if there is
conflicting opinions by the peer review, how is that dealt
with? Does that appear in your draft assessment that there are
conflicting reports?
Mr. Anastas. The results of conflicting opinions are
resolved within the peer review committee themselves. They can
represent the different perspectives in their peer review
report and we would receive that report.
Mr. Harper. So is the public ever made aware that there may
have been a difference of opinion before that came to you?
Mr. Anastas. Thank you. What is a very important point that
I should have emphasized is that these peer review panels are
publicly held. We receive public comment. The peer reviews are
publicly available so actually one of the things that was
emphasized by GAO is the necessary transparency, and that is
something that is very transparent in this process is the peer
review.
Mr. Harper. When the peer review is being completed, once a
final assessment is done, is that final assessment on track to
be reevaluated? Is it a perpetual continuous reevaluation? Or
something new comes in, is that subject to being changed?
Mr. Anastas. There are over 500 assessments on the IRIS
database currently, and one of the ongoing processes where we
seek public input, we receive input from our various program
offices and regional offices is input on what should be in the
pipeline for highest priority either due to knowledge of
additional scientific information that requires updating or a
need to address actions that need to be taken. So that is how
we inform how things get updated in what order. As was
referenced earlier, this is an ongoing challenge and why it is
so important that we have increased the pace of these
assessments.
Mr. Harper. Can you give me the difference between
chemistry and green chemistry?
Mr. Anastas. Certainly. Chemistry is the study of all
matter and material and its transformations and green chemistry
is looking at how you manipulate the molecules, how you build
them from the atoms up so that they have a reduced ability to
cause toxicity to humans or the environment. In the same way
that we can design a substance to be green or blue, flexible or
brittle, we can design it so that it is either capable of
causing harm or far less capable of causing harm.
Mr. Harper. Well, when I went to college, you could major
in biology or chemistry. Do you anticipate that we will see
green chemistry majors in our universities?
Mr. Anastas. As a matter of fact, there are Ph.D. programs
in major universities both in the United States and elsewhere
in green chemistry. There are degree programs in everywhere
from the U.S., India, China, Australia, and the U.K.
Mr. Harper. If I have time, I would like to ask Dr. Trimble
a question if I may. And I am going to reach a quick peer
review committee. This was the NRC formaldehyde committee
review just a quote here.
It says, ``the committee is concerned about the persistence
of problems encountered with IRIS assessments over the years
and the draft was not prepared in a consistent fashion. It
lacks clear links to an underlying conceptual framework and it
does not contain sufficient documentation on methods and
criteria for identifying evidence from epidemiologic and
experimental studies, for critically evaluating individual
studies, for assessing the weight of evidence, and for
selecting studies for derivation of the RFCs and unit risk
assessments.''
Tell me your opinion on that, what that statement was.
Mr. Trimble. This may be better directed to NAS since GAO
has not looked or assessed the NAS's study.
Mr. Harper. Well, certainly defer then.
Mr. Dorman. Yes, sir. So what we mean by that is that
oftentimes when one is trying to put together a database, when
you are basically doing literature reviews, before you begin
that process, you start to lay out a framework by which you are
going to evaluate the literature. And so as you are starting to
go looking at literature, you will find, per se, a chemical
like formaldehyde there is literally thousands of articles
available in the published literature on a chemical where if
you search the database using a word like formaldehyde you will
find. And so one needs to have a process by which you start to
kind of weed that evidence down to a sub-selection of studies
and then eventually key studies that you start to use in your
assessment, and we just felt that EPA was not transparent in
defining that process by which they would both identify what
literature you were finding and then either accept or not
accept certain studies and bring them forward in their
assessment.
Mr. Harper. I realize I am out of time and if I may, Dr.
Trimble, what I was wanting to ask was this: the conclusions in
that formaldehyde review committee seemed to indicate that the
same problems that were noted by GAO in '06 are still evidence
in IRIS and I just want to know if you agree or disagree?
Mr. Trimble. I will probably punt on this. This is going to
be part of our ongoing review, which we will be reporting on in
the next couple of months looking at how the process has gone
since then and part of that review will be looking at the NAS.
Mr. Harper. That was a very polite way of not----
Mr. Trimble. Yes, I apologize.
Mr. Harper. Thank you.
Mr. Shimkus. The gentleman yields back his time.
The chair now recognizes the gentleman from North Carolina,
Mr. Butterfield, for 5 minutes.
Mr. Butterfield. Let me thank you, Mr. Chairman, for
convening this very important hearing today and particularly we
thank the witnesses for their testimony.
Mr. Chairman, IRIS, as we all know, is the foundation of
our public health and environmental policy and it should be
reviewed periodically to ensure it is being carried out at peak
performance. And so the witnesses' testimony today has been
very helpful on this subject.
I believe to properly evaluate IRIS's performance, we must
have absolute clarity on the function of IRIS. Dr. Anastas, let
me start with you. Does IRIS make risk assessments?
Mr. Anastas. No, what IRIS does is provide important
scientific information that gives insight on the hazards of
chemicals and potential health consequences of various
chemicals, but in order to have it be a full risk assessment,
it needs to have the exposure component. So while this
information is fundamental and essential, it is not a full and
complete risk assessment.
Mr. Butterfield. So do you only make hazard assessments or
do you do both?
Mr. Anastas. The risk assessments are done as part of the
regulatory process in our regulatory office.
Mr. Butterfield. But don't you agree that this is a very
important distinction between these two?
Mr. Anastas. It is a tremendously important distinction,
one that is often confused. Many people do view IRIS members as
regulations, as risk assessments, and it is an important
distinction that this is looking at just this element of the
scientific information.
Mr. Butterfield. That is very helpful.
Now, does IRIS make EPA regulations? I think we know the
answer but I want you to go on the record and say that.
Mr. Anastas. Well, we know how important IRIS values are to
regulations. They are not regulations and they are not making
regulations.
Mr. Butterfield. So could we say, then, that the primary
work of IRIS is to evaluate and integrate existing scientific
literature into assessments of potential hazard which are then
used by EPA program offices and others to gauge risk and
eventually set thresholds for exposure in programs? Is that
correct?
Mr. Anastas. That is correct.
Mr. Butterfield. In a little while, Dr. Anastas, we are
going to hear from Dr. Honeycutt of the Texas Commission on
Environmental Quality. He will claim that the EPA's most recent
assessment on formaldehyde calls into question the safety of
its hailing. Dr. Honeycutt will state that using EPA's most
recent assessment, formaldehyde in your breath that results
from normal body functions would be five times higher than the
highest level of EPA would call safe. Was the IRIS assessment
asserting that this room is now unsafe due to all of the
formaldehyde producers currently being breathed at this time?
How would you respond to this assertion and what are the
implications?
Mr. Anastas. Well, the IRIS assessment was not concluding
or implying that this room is unsafe because of the air that we
exhale. The formaldehyde assessment benefitted greatly from the
comments that were supplied by the National Academies and the
comments that the National Academies provided are being
addressed to strengthen that assessment. But no, the answer is
no, the assessment did not imply that we are at risk because of
the air that we are breathing in this room.
Mr. Butterfield. Yes. Thank you very much.
Thank you, Mr. Chairman. I yield back.
Mr. Shimkus. I thank my colleague. I would just note, Dr.
Anastas, in your response you said ``not concluding,'' brings
up my question about are you doing a risk assessment? So that
is the part of this whole debate that we are looking into.
The chair now recognizes the gentleman from Pennsylvania,
Mr. Pitts, for 5 minutes.
Mr. Pitts. Thank you, Mr. Chairman.
Dr. Anastas, is the source of a study's funding an
automatic disqualifier of the contents or quality of the
research no matter how well characterized or high quality such
a study is?
Mr. Anastas. The evaluation of a study is based on the
scientific integrity of the study. So the short answer to your
question is no. The importance of the rigor of the study, the
way that the study is conducted are the important determining
factors. With regard to such things as the peer review and peer
review panelists, ethical and conflict of interest are
considered at that point, for instance, for peer reviewers, but
in the conduct of the study, it is the scientific rigor of the
study.
Mr. Pitts. Other than industry funded, please tell the
committee what other types of funding exist for high-quality
scientific work?
Mr. Anastas. I think there is extensive funding for high-
quality research provided by the Federal Government. There is
certainly a wide range of our scientific agencies provide
funding to researchers to conduct on a wide range of topics
including toxicology, epidemiology, and these are important
sources of funding. Whether it is the National Science
Foundation, the National Institutes of Health, and of course
the Environmental Protection Agency.
Mr. Pitts. Has the EPA ever contracted with the private
sector or intentionally obtained scientific research that was
paid for by a private interest?
Mr. Anastas. I want to make sure that I give you an
accurate answer so I don't want to be definitive without
checking all of the facts. What I will pledge to do is get back
with you with a clear answer on that question.
Mr. Pitts. All right. To what extent does IRIS rely on the
scientific pronouncements made by other federal agencies or
coordinate with them on their activities like NTP or ATSDR?
Mr. Anastas. One of the things that we ensure doing is
coordinate what assessments will be done so that we certainly
wouldn't want to be duplicative or overlapping or redundant. We
coordinate with sister agencies not only which assessments to
do to make sure that we are complementary wherever appropriate
but also coordinate in our interagency reviews. Interagency
reviews are transparent and inclusive and we rely heavily on
the scientific expertise on our sister scientific agencies and
health agencies, as well as others.
Mr. Pitts. Thank you.
Dr. Dorman, in your opinion, has EPA's IRIS process evolved
to reflect improvements in the field of risk assessment?
Mr. Dorman. So speaking for myself and not as a member of
the panel, I think that approaches have been kind of mixed. In
some areas, IRIS has been more considerate of modeling efforts
and things like that which reflect more state-of-the-art. I
think there are other areas in which the IRIS assessment
program probably lags a little bit behind. But I think that
IRIS does try to keep up and I think the EPA should be, you
know, recognized for trying to keep up with the science as it
is evolving.
Mr. Pitts. Are you familiar with other branches of the
Federal Government that are engaged in risk assessment, and if
so, do those offices employ best practices that could be
applied here?
Mr. Dorman. I serve and do an advisory role on different
aspects for the Federal Government, and I think there are some
examples of best practices. Speaking on behalf of the
committee, we did identify some of those best practices that we
thought could serve a template for the Agency as they move
forward on looking at revising the IRIS program.
Mr. Pitts. How important is it for the American public that
the integrated risk assessment process results in a reasonably
correct assessment and what are the practical consequences of
an overly precautionary assessment? What are the practical
consequences of an assessment that does not identify risk?
Mr. Dorman. Again, I think as Dr. Anastas pointed out the
IRIS program is not doing the risk assessment per se; they are
trying to compile the data regarding hazard identification, but
I think that is extremely critical for folks. And I think it is
not only an issue of an economic issue, but it is also a public
health issue where the public doesn't become alarmed over
health effects that may or may not be present with a certain
chemical. And I think that is another area that, you know, the
EPA IRIS documents do try to identify hazard identification and
I think it is very critical for the public that it is done in
the right way.
Mr. Pitts. Thank you, Mr. Chairman.
Mr. Shimkus. The gentleman's time has expired.
The chair recognizes that we have been joined by my
colleague from Georgia, which I think he will----
Mr. Barrow. I thank the chairman. I will waive.
Mr. Shimkus. He waives. The chair now recognizes the vice
chairman of the subcommittee, Mr. Murphy, for 5 minutes.
Mr. Murphy. Thank you, Mr. Chairman.
Dr. Anastas, the EPA has a draft of the IRIS toxicology
report for hexavalent chromium, is that correct?
Mr. Anastas. Correct.
Mr. Murphy. Are you aware that on May 12, 2011, a panel of
independent chromium experts had significant concerns with that
draft?
Mr. Anastas. I am aware of that peer review.
Mr. Murphy. And is the EPA prepared to incorporate more up-
to-date scientific research in that based upon the information
that came from the peer review and other input?
Mr. Anastas. We are evaluating that peer review. We are
evaluating the comments and concerns. While no decisions have
been made, it is the practice that I have stated and I
appreciate the opportunity to emphasize that we consider and we
address the concerns raised in peer review.
Mr. Murphy. Is there anything you recall in that peer
review study that sticks out that says there is something that
raises concerns of a particularly salient nature for you?
Mr. Anastas. I think that this peer review has raised a
number of questions about the science that is currently being
conducted and the potential value of that science informing the
assessment upon its completion.
Mr. Murphy. Are you aware also of the NTP study, the doses
given to test animals, that something like 5,000 parts per
billion but the national drinking water standard for total
chromium is 100 parts per million, and drinking water
monitoring indicates that hexavalent chromium in drinking water
is only about 1 to 4 parts per billion? I mean these seem to be
pretty radical differences in terms of information that has
come out on hexavalent chromium research versus what is really
out there. How do you evaluate that sort of information when
you see studies looking at some extremely high levels and then
related to what is really out there?
Mr. Anastas. It is certainly I will say a traditional
methodology when studying the toxicity of a particular chemical
that you want to be able to get up to the level where you see a
particular toxic effect, and sometimes these levels that are
required are fairly high as you mentioned. And then there is
the necessary extrapolation. So this is not necessarily unusual
for studies of this type.
Mr. Murphy. But you are also drawing conclusions based upon
having toxic levels can give us some misinformation. For
example, a person can reach a toxic level of ingestion of H2O,
but that doesn't mean we draw conclusions based upon that. And
I just want to make sure that we are also looking at these
levels. I mean what is the real risk? Because none of us want
to misdiagnose and then mistreat the problem.
Mr. Anastas. This is the basis of dose response----
Mr. Murphy. Um-hum.
Mr. Anastas. --and getting these dose response curves, the
ability to determine at which dose an effect may take place or
a no-effect level is the basis of dose response, and so this is
something that I know that Dr. Dorman teaches in his classes
all the time in North Carolina.
Mr. Murphy. I also heard our EPA administrator talk about
dose response curves and we should look at that.
Now, the Natural Resources Defense Council I believe
suggested that chromium alloys pollute our soil and water
supplies, but I want to make something clear. Isn't it true
that there is no association between the use of chromium alloys
in stainless steel in any pollution or illness? Am I correct in
that?
Mr. Anastas. What we are looking at in the IRIS assessments
is the toxicity and the one we are discussing is the toxicity
of chromium-6 and different matrices you can expect different
considerations, and that is part of the risk assessment/risk
management calculation.
Mr. Murphy. OK. Is that chromium-6 something that is used
in stainless steel?
Mr. Anastas. I believe chromium-6 is used in stainless
steel.
Mr. Murphy. When it is used in stainless steel, I mean
stainless steel is also seen as containers for clean drinking
water, surgical equipment, et cetera. Is that an issue that
that chromium is actually leaching out of that stainless steel
and contaminating those things?
Mr. Anastas. Nothing in the IRIS assessment addresses any
of those risk scenarios.
Mr. Murphy. But you can look at things outside of the IRIS
assessment? Here is my concern: If we are saying that that is a
toxic chemical but it is used in containers which are used to
have non-toxic water and sterile equipment, is it correct,
then, in saying that that chromium is actually leaching out and
causing problems?
Mr. Anastas. You are identifying extremely important risk
management decisions and exposure factors. Those are exactly
the type of questions that are----
Mr. Murphy. You are not giving me an answer. You are just
saying it is important. I need to know----
Mr. Anastas. What I am saying is that nothing in this
health assessment would address those questions.
Mr. Murphy. I still don't have an answer but I realize my
time is up. Thank you, Mr. Chairman.
Mr. Shimkus. Thank you. And at this time I recognize my
friend from Colorado, Ms. DeGette, for 5 minutes.
Ms. DeGette. Thank you very much, Mr. Chairman.
Dr. Anastas, I want to ask you a couple of things I read in
your written testimony. One is about this rider that was
attached to the interior EPA appropriations bill this summer
that would have delayed all IRIS assessments until the NAS
recommendations were adopted and would have required NAS review
of additional draft assessments. Does the administration
support that policy?
Mr. Anastas. What I can say is that the effect of those
letters would be significant. I believe that Mr. Trimble did
mention the concern I think that we all share of making sure
that assessments come out in a timely way. The result of these
riders would be significant delay of perhaps as much as a year
or 2 years, and an important factor to consider is during that
delay, would the assessments that are in development be brought
out of date? So the impacts of this would be significant and
cascading throughout not only the development of the
assessments themselves but the use of these assessments.
Ms. DeGette. What types of significant and cascading
developments would there be?
Mr. Anastas. As was mentioned earlier, these assessments
are important as a foundation for different decisions and
actions not only in the Agency but by States and municipalities
and industry. Would these assessments then be able to inform
regulatory decisions or other decisions? The answer of course
is no because they would be delayed by these actions.
Ms. DeGette. Do you think there would be an effect on
public health or the environment by these delays?
Mr. Anastas. I certainly believe that our regulatory
decisions, the decisions at the state and local level and
decisions made by companies and individuals impact human health
and the environment, and so yes, if----
Ms. DeGette. OK. Your answer is yes.
Mr. Anastas. My answer is yes.
Ms. DeGette. Thank you. Now, thinking about it from the
other side of the issue, the chemical industry and economy in
general, if we had uncertainty in these standards, would that
potentially also be harmful to them since they wouldn't know
what was coming down the pike?
Mr. Anastas. I think the lack of knowledge is always
difficult and something to try to avoid, which is why we try to
get this information out.
Ms. DeGette. Mr. Trimble, GAO has raised concerns about the
delays in the IRIS process, and you talked about that earlier
and what that would mean for the credibility of assessments.
Would suspending all assessments and all actions on past
assessments impact the utility and credibility of the program?
Mr. Trimble. I think as Dr. Anastas indicated, the impact
would be felt most immediately by the program offices at EPA,
as well as the States and others that rely on that to make
regulatory decisions.
Ms. DeGette. So there would be a lack of certainty?
Mr. Trimble. Yes, certainly there would be a lack of
certainty and predictability. Certainly.
Ms. DeGette. Now, in your testimony you talk about the
compounding effects of delays on assessments and Dr. Anastas
referred to that. Can you please explain what you mean by that?
Mr. Trimble. Yes, what we have reported on in the past is
that when studies in the past have been suspended or delayed,
what happens is that science keeps marching so that when you
start to restart that study, a lot of the work has to be redone
because there is new scientific literature. We have talked
about evolving scientific methods, for example, you know,
quantifying risk and things like that. All of those, the state-
of-the-art practices change over time, so when you stop and
delay, you have to catch up to what is now cutting-edge science
to move forward and that causes delays.
Ms. DeGette. In your testimony you mention that IRIS
processor forms are not established in regulation or statute.
Do you have any ideas for this committee about what we can do
about that that you would like to share with us?
Mr. Trimble. Well, with that I would politely demur on
this.
Ms. DeGette. I thought you might.
Mr. Trimble. We have a report that is coming out by the end
of this year looking at the implementation of the IRIS programs
since the 2009 changes, so we will be reporting on that
shortly.
Ms. DeGette. Mr. Chairman, we will all look forward to
getting a copy of that report. And I yield back.
Mr. Shimkus. The gentlelady yields back her time.
I ask unanimous consent for Mr. Murphy to do a unanimous
consent request.
Mr. Murphy. Mr. Chairman, I just ask this letter from the
Specialty Steel industry of North America be submitted for the
record in which it states, ``no hexavalent chromium is present
in steel alloys.''
Mr. Shimkus. That has been shared with the minority? Is
there objection? Hearing no objection, so ordered.
[The information follows:]

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Mr. Shimkus. The chair now recognizes the gentleman from
New Hampshire for 5 minutes, Mr. Bass.
Mr. Bass. Thank you very much, Mr. Chairman.
I want to thank you all for your time and interest in being
here today.
Dr. Anastas, OMB guidance defines ``highly influential
scientific assessment'' as ``a scientific assessment that could
have a potential impact of more than $500 million in any year
on either the public or private sector or is a novel,
controversial, or precedent setting or has significant
interagency interest.'' Because the estimates support the
Agency's regulatory activities, including costly cleanups, are
the IRIS assessments routinely recognized as highly influential
scientific assessments subject to the information quality and
peer review guidelines?
Mr. Anastas. I think the important discussion that we have
been having has shown that these assessments are scientific
inputs into regulatory decisions. They are not regulations;
they are not regulatory conclusions. The considerations for
economic impact are important and essential and a serious part
of the deliberations that the Agency has, but these assessments
are not regulations and should not be viewed as such.
Mr. Bass. Well, I guess then in making the determination
whether an IRIS assessment is ``highly influential,'' how does
the EPA determine whether more than $500 million worth of
future impacts are likely?
Mr. Anastas. The results of regulatory decisions undertake
extensive cost-benefit and regulatory impact analyses. Perhaps
the most important point that I could make on this is that
while we are, through these assessments, identifying the hazard
profile of these substances, in the absence of exposure, there
is no risk. If there is no exposure, there is no risk and so
there would be no reason for its management. And so while these
are important inputs, it would be wrong to assume that because
something has a particular hazard profile it is necessarily
going to trigger a regulatory action.
Mr. Bass. Is it possible that any IRIS assessment could
later be incorporated in a regulation that has impacts of more
than $500 million?
Mr. Anastas. Yes.
Mr. Bass. OK. All right. I am all set, Mr. Chairman. Thank
you.
Mr. Shimkus. The gentleman yields back his time.
The chair now recognizes the gentleman from Louisiana, Mr.
Cassidy, for 5 minutes.
Mr. Cassidy. Mr. Anastas, you mention, going back to Mr.
Barton's questions, regarding how you define premature. Let us
take a person with emphysema. We know that person with
emphysema is more likely to have complications from an inhaled
toxin, pick ozone, so if the person with emphysema dies at 74
because of a bronchospastic asthmatic event triggered by ozone,
is he, compared to the average age someone dies, say 82 for a
man, or is he compared to the average age that somebody with
emphysema dies?
Mr. Anastas. So when we are looking at statistical
population distributions, that distribution is going to have
various susceptibilities--people who are particularly
susceptible----
Mr. Cassidy. Correct.
Mr. Anastas [continuing]. And people who are particularly
resilient. So what we are talking about is average lifespan and
how different effects would affect a----
Mr. Cassidy. Correct.
Mr. Anastas [continuing]. Population. So I would not draw
that conclusion based on an individual because I believe that
that would not be a statistically robust approach.
Mr. Cassidy. Wait, you don't adjust for co-morbidities when
determining whether somebody dies prematurely because of
exposure to a toxin?
Mr. Anastas. No, I am saying that certainly susceptible
populations do reside within that overall population----
Mr. Cassidy. But I think----
Mr. Anastas [continuing]. But I am saying that I wouldn't
apply it to an individual.
Mr. Cassidy. I can tell you that that would be counter to
what you would do--I am a doctor. That is what you would do in
medicine. You would account for co-morbidities knowing that co-
morbidities have a huge influence upon the body's reaction to
an external event.
Mr. Anastas. And I absolutely agree that in dealing with an
individual you absolutely need to factor in the individual's
susceptibility.
Mr. Cassidy. But I gather that you are not comparing them--
--
Mr. Anastas. That would be the logical calculation.
Mr. Cassidy. But I actually think that you actually could
find--go to the VA database, for example--find the average
lifespan for somebody with a certain level of pulmonary
impairment and you would find, yes, for this degree of
impairment they die and this degree they die at this age. But I
gather that is not necessarily done?
Mr. Anastas. I am saying that in many of the
epidemiological studies that are relevant to the discussion
that we were having about decreased lifespan, that that has not
been the basis of those types----
Mr. Cassidy. OK. I got my answer. And I didn't mean to be
rude. I don't mean to be curt. I apologize.
Dr. Dorman, did you participate in the critique of this
report, the IRIS report for formaldehyde?
Mr. Dorman. Yes, sir.
Mr. Cassidy. Now, I am struck because I just kind of
quickly eyeball it. I am quickly eyeballing it so it may come
in totally wrong. Join my wife on most occasions.
If the lack of knowledge is a bad thing, misinterpretation
of knowledge is even worse. As I look at the summary of your
report, you say that ``the committee concludes the weight of
evidence suggests formaldehyde unlikely to appear in blood as
an attack molecule.'' You go on to say that, you know, kind of
absorbed, quickly metabolized, it goes away, unlikely to have a
systemic effect. That is kind of the, you know, as I scan what
I am getting. So even though this is 1,000 pages--I looked it
up--it is 1,043-page report talking about all the things it
will do to rat urine and, you know, to human nasal mucosa,
really all that strongly suggests there is pertinent physical
effects, and yet your report finds that that may be overstated.
Is that a fair statement?
Mr. Dorman. So I think it is a fair statement that the
Academy concluded that the current best evidence indicates that
formaldehyde does not reach the systemic circulation in an
appreciable way. And so what we did recognize as well, though,
is that formaldehyde might have certain health effects that may
not require it being delivered systemically. And so, for
example, if we have say rhinitis or an irritation in the nose,
you might also have headache. Even though that chemical never
got to the brain, that would be an example say of a stress that
might be associated with that inflammation in the nose.
Where we differed from the conclusions probably related
most to the motive action that EPA was considering for the
leukemogenic responses that have been associated with
formaldehyde exposure where we felt that the weight of evidence
didn't strongly support their conclusions.
Mr. Cassidy. Yes, I am kind of struck that there is 1,043
pages of stuff which documents and if you just read it, you
think oh my gosh, isn't this terrible? Then I read your report
and when you actually analyze it and put it in context, it
isn't quite so frightening. Worrisome, but not quite that 1,043
pages of we have got to regulate. I agree with that.
I also say, as a physician, it seems kind of routine. I am
not sure why it has taken you so long to implement these
suggestions I put forth because frankly, as a physician, if
there is not rigor of methodology being explained, then the
paper would never be published in a peer reviewed journal. That
seems to be kind of a standard sort of scientific method of
presentation.
Mr. Anastas. If I could just mention that this is a draft
assessment. We put out draft assessments for the purpose of
getting this kind of critique so that we improve it for the
final assessment. This is what we do. This is why we seek it
out.
Mr. Cassidy. Can I have just a minute more?
Mr. Shimkus. Without objection, gentleman is recognized for
another minute and a half.
Mr. Cassidy. OK. Thank you.
Going back to green chemistry, it seems to me as if that
would be the basis for a proposal regarding inherently safer
technology.
Mr. Anastas. Correct.
Mr. Cassidy. Now, that actually seems you move beyond I
think Mr. Butterfield suggested your role as analytic--and I
will maybe paraphrase--analytic not prescriptive, but that is a
little disingenuous if you are saying listen, we are going to
make a value judgment as to whether or not this has a toxic
effect and this does not. And frankly, there will be
assumptions that credible scientists may disagree with your
assumptions, and yet your findings are going to be the basis, I
bet you, for regulation promoting inherently safer technology.
How would you disagree with that?
Mr. Anastas. What I tried to emphasize in my statement was
when the information that we generate gives us insights not
only that an individual substance may or may not be toxic and
in what ways but how it is toxic, that gives us insights into
the design----
Mr. Cassidy. But you are making an assumption of toxicity
that again scientists in a peer reviewed journal would disagree
with your assumption, but yet your assumptions are going to
guide this green chemistry which is going to guide an IST
regulation.
Mr. Anastas. With all due respect, what I am saying is not
on the level of toxicity but the mechanisms by which it has any
kind of biological effect. This informs the design of the
molecular structures of future chemicals so that we can
minimize the possibility, the probability----
Mr. Cassidy. Give me a specific because right now that
sounds very nice, but as I try and think of the particular, it
seems you can't divorce yourself from assumptions of the
toxicity and we already see credible dispute with your
assumptions of toxicity.
Mr. Anastas. When I am looking at a molecular structure, I
know that whether or not a substance has the ability to even
cause any type of toxic effect----
Mr. Cassidy. But water can drown. Do you see what I am
saying? Water has a toxic effect if you put your head
underneath it for too long. And so you are right, there has to
be a dose effect, and there has to be a certain substrate in
which it interacts. How do you account for that?
Mr. Anastas. If a substance cannot be inhaled, if a
substance cannot be respired, ingested across biological
membranes, those are all based on its physical/chemical
properties. What chemists do is develop structures to control
their physical/chemical properties. You can design a substance
to have those physical/chemical properties so as to reduce the
probability that it can cause hazardous adverse consequences.
Mr. Cassidy. I still can't--so formaldehyde----
Mr. Shimkus. The gentleman's time has expired.
Mr. Cassidy. Thank you. I yield back.
Mr. Shimkus. There are too many doctors in this room. The
IQ has gone up and I can't even understand the English being
spoken here sometimes. I ask unanimous consent. My colleague
Mr. Green wanted to make a statement before we adjourn this
panel.
Mr. Green. Mr. Chairman, I know we have votes going to be
scheduled and I think we have exhausted our questions of the
panel. I want to thank the panel. I know, Doctor, you had to
change your plans to be here but when I referred to the dioxin
facility in our district--actually in Ted Poe's district--but
EPA worked in both administrations, both in '08 and '09, what I
consider bureaucratic light speed to get that site on there,
and we actually have it encapsulated now. And the next panel we
have our Texas Commission on Environmental Quality. They
actually are the ones that did the research to trace where all
this dioxin would be coming from in the San Jacinto River, so
that is a great example. Most people get mad at EPA. Here in
Texas, you all don't think we do anything for the environment,
but we do. Thank you.
Mr. Shimkus. And the chair now also wants to ask unanimous
consent that the letter dated October 4 from the American
Chemistry Council be submitted for the record. That has been
shared with the minority. Without objection, so ordered.
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Mr. Shimkus. I too want to thank the first panel and for
the second panel we will convene you after votes and they
should be calling them any minute. So it really is not
productive for us to start. And we will reconvene after votes.
So with that, I will recess this hearing.
[Recess.]
Mr. Shimkus. We can get through the next panel and also get
in between votes on the floor of the House, but I think we have
got plenty of time, but we do want to get started.
We want to welcome you. Thank you for your patience. I will
do as I did with the first panel I am going to introduce you
all across the board, and then we will recognize you
individually for your 5-minute opening statements. Because of
the time that we have, you know, I won't hold you strictly to
the 5 minutes, so take your time. Make sure what you want to
present is not rushed.
So on this second panel, we again appreciate you all for
being here. We have Dr. Michael Honeycutt, Director of
Toxicology Division, Texas Council on Environmental Quality. We
also have Dr. Harvey Clewell, the Hamner Institutes for Health
Sciences. We have also have Mr. Jerry A. Cook, Technical
Director, Chemical Products Corporation. It is good to see a
mister and not all doctors. And then finally Dr. Thomas A.
Burke, Associate Dean for Public Health Practice and Training,
Department of Health Policy and Management at Johns Hopkins
Bloomberg School of Public Health.
Gentlemen, thank you for joining us, and I would like to
recognize Dr. Honeycutt for 5 minutes for his opening
statement.

STATEMENTS OF MICHAEL HONEYCUTT, DIRECTOR OF TOXICOLOGY
DIVISION, TEXAS COMMISSION ON ENVIRONMENTAL QUALITY; HARVEY
CLEWELL, DIRECTOR, CENTER FOR HUMAN HEALTH ASSESSMENT, THE
HAMNER INSTITUTES FOR HEALTH SCIENCES; JERRY A. COOK, TECHNICAL
DIRECTOR, CHEMICAL PRODUCTS CORPORATION; AND THOMAS A. BURKE,
ASSOCIATE DEAN FOR PUBLIC HEALTH PRACTICE AND TRAINING,
DEPARTMENT OF HEALTH POLICY AND MANAGEMENT, THE JOHNS HOPKINS
BLOOMBERG SCHOOL OF PUBLIC HEALTH

STATEMENT OF MICHAEL HONEYCUTT

Mr. Honeycutt. Good morning, Mr. Chairman and members of
the committee. My name is Michael Honeycutt. I am director of
the Toxicology Division at the Texas Commission on
Environmental Quality. I would like to touch briefly on Texas'
perspective on the science that EPA is using or not using for
chemical risk assessments in recent years and the implications
for regulatory agencies and the public.
I have been a toxicologist and a risk assessor for Texas
for over 15 years. In past years, we have had disagreements
with EPA, but they have not really been based on science issues
so much as on policy issues. An example of this would be that
EPA does not want to consider TCEQ rules, which in many cases
are more stringent than their cleanup values when addressing a
cleanup site in Texas. However, we have always been able to
work out our differences amicably.
In recent years, though, EPA chemical risk assessments have
become more precautionary in nature instead of relying on
scientific data. The heart of the matter is that EPA is moving
toward the philosophy that there is no safe level of exposure
to a chemical and this is contrary to the cornerstone of the
science of toxicology. This change in philosophy results in
unrealistically low regulatory levels. And as a result,
naturally occurring levels of chemicals may be higher and often
cases it is higher than EPA-safe level.
As an example, using EPA's most recent draft assessment of
formaldehyde, the formaldehyde in your breath that results from
normal body functions would be over five times higher than the
highest level that EPA would call safe. Formaldehyde is
naturally formed in the air from the breakdown of chemicals
released from vegetation, and according to available air data,
the only places that would have safe air would be remote
locations such as the arctic and South Pacific islands.
In another example, using EPA's most recent draft
assessment of arsenic, all fish and shellfish would contain
levels of inorganic arsenic that are higher than the highest
levels EPA would consider safe. And it is not just fish. Normal
dietary food and drinking water consumption would also have
arsenic levels substantially higher than EPA-safe level. And we
just know that this isn't true. We aren't seeing the health
effects that would be predicted or expected in the general
population based on EPA's new values.
While we do agree with EPA on being precautious in areas
where we don't have good science, we strongly believe that good
science should not be ignored and should trump EPA's overuse of
precaution. Hexavalent chromium is a good example of this.
EPA's recent conclusion that ingesting hex chrome likely causes
cancer in humans is based on a study where mice received
extremely high levels of hex chrome, and EPA dismissed the
human epidemiology and the wealth of other data that contradict
this. And in those human studies, there was an occupational
study where workers actually had yellow teeth and yellow
tongues from ingesting so much arsenic.
And TCEQ isn't the only organization concerned about the
science behind EPA's recent assessments. The National Academy
of Sciences, many prominent academic researchers, other states
and other countries have noted the lack of good science in
these assessments.
Because of the lack of scientific defensibility and the
implications of EPA's new chemical assessments, Texas has
recently decided to develop our own chemical assessments. We
have written two state-of-the-science guidance documents and
had them externally scientifically peer reviewed by panels of
imminent scientists, including scientists from EPA, California
EPA, and Canada, and we are in the process of putting our
latest document through a second round of public comment.
We had no desire at all to use our limited resources to
develop these chemical risk assessments that we have
historically been able to rely on EPA for. However, the
implications of EPA's new assessments have forced our hand.
EPA's new assessments will unnecessarily scare the public and
may actually harm public health by diverting public, industry,
and government attention and resources away from public health
issues that may pose more of a risk.
As an example, EPA currently encourages pregnant women to
limit their consumption of fish due to concerns of mercury.
However, numerous recent studies show that the health benefit
from pregnant women eating fish outweighs the potential risk
for mercury. If EPA finalizes their draft arsenic value as it
currently stands, then the public, the media, and advocacy
groups would perceive fish as being even more unsafe resulting
in even more pregnant women avoiding fish and its proven health
benefits for them and their infants.
There are also significant implications for remediation
programs all across the country. Typical soil and water
concentrations of chemicals, even some naturally occurring,
would be considered unsafe. In other words, there is no safe
place to live. How can you cling to below-background levels if
background levels are unsafe? All replacement soils that we
would use to fill in a backyard would also contain these unsafe
background levels. So where are we going to put this so-called
contaminated soil that we would have to dig up from somebody's
yard?
Your constituents will not stand for having soil and water
that is deemed unsafe by EPA's new risk assessments even if it
is naturally occurring and we can't do anything about it. So
these are just some of the issues that we will have to face if
EPA stays on their course, and I thank you for this opportunity
to testify.
[The prepared statement of Mr. Honeycutt follows:]

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Mr. Shimkus. Thank you for your testimony.
And now I would like to recognize Dr. Harvey Clewell. Sir,
you have 5 minutes. And we are getting you fresh water. And you
are recognized.

STATEMENT OF HARVEY CLEWELL

Mr. Clewell. Thank you, Mr. Chairman. Good morning, Mr.
Chairman, members of the subcommittee. My name is Harvey
Clewell. I am the director for the Center for Human Health
Assessment at the Hamner Institutes for Health Sciences in
Research Triangle Park, North Carolina.
In my position at the Hamner, as well as in my previous
consulting positions, I have performed risk assessment research
and consulting for a large number of government and industry
clients, including the EPA. I am here today to present my
professional opinions. I am not representing the Hamner or any
other organization.
I am very familiar with EPA risk assessment practices. Over
the last 30 years, I have assisted EPA on risk assessments for
a number of compounds including methylene chloride, cadmium,
styrene, vinyl chloride, trichloroethylene, chloroform, and
perchlorate. I have served on the EPA's FIFRA Scientific
Advisory Panel and the recent EPA Science Advisory Board on
IRIS assessments for dioxin. I have also served as a peer
reviewer for a number of recent EPA guidelines, including those
for cancer risk assessment and risk characterization.
I consider EPA to be a leader in advancing risk assessment
methods and have been favorably impressed by a number of recent
IRIS assessments for which I was a peer reviewer, including
those for one for dioxane and acrylamide. Nevertheless, I am
concerned that the lack of objectivity and transparency in some
recent IRIS assessments will impair the ability of decision-
makers to make informed risk management decisions.
I am particularly concerned that in some recent IRIS
assessments, such as those for inorganic arsenic, formaldehyde
and dioxin, only a single cancer risk assessment approach has
been presented: a low-dose-linear default that assumes these
chemicals are carcinogenic at any concentration. However, there
is strong evidence for each of these chemicals that the true
dose-response is nonlinear, and that the default greatly
overestimates the actual risk at current human exposure levels.
This IRIS practice of presenting only a single approach
disregards the recommendation in the OMB memorandum entitled,
``Updated Principles for Risk Analysis,'' to provide a
characterization of the dispersion of risk estimates associated
with different models, assumptions, and decisions. The OMB
principles provide valuable guidance for assuring that risk
assessments adequately inform decision-makers faced with
complex risk management options. Following the OMB
recommendations should be a key objective of all IRIS
assessments.
The failure to objectively describe the evidence for
alternative risk assessment approaches and to provide risk
estimates other than the default has been a major deficiency in
the IRIS risk assessment process. Even in the case of IRIS
cancer assessments where alternative low-dose extrapolation
options are discussed, there has been a clear bias towards
presenting evidence that supports the selection of the default
linear approach, even in cases where there is strong support
for a nonlinear approach in the scientific community. Decision-
makers would be better informed by a balanced and objective
discussion of both alternatives and the presentation of
analyses based on both alternative approaches in the risk
characterization section of the assessment.
As a justification for presenting only the default low-
dose-linear risk assessment approach, the IRIS assessments have
cited uncertainty in the evidence for alternative approaches.
However, EPA guidance states that in the face of uncertainty,
multiple approaches can be presented. The EPA's 2005 Guidelines
for Carcinogen Risk Assessment state that ``Nonlinear
extrapolation having a significant biological support may be
presented in addition to a linear approach when the available
data and a weight of evidence evaluation support a nonlinear
approach, but the data are not strong enough to ascertain the
mode of action applying the Agency's mode of action framework.
If more than one approach, e.g. both a nonlinear and linear
approach are supported by the data, they should be used and
presented to the decision-maker.''
In a number of cases, NAS and the EPA Science Advisory
Board peer reviews have requested that the IRIS assessment be
modified to objectively present multiple risk assessment
options but the Agency has not complied. I believe that the
repeated refusal of the EPA to implement recommendations from
the NAS and SAB peer reviews to objectively present alternative
risk assessment options has greatly delayed the completion of
the IRIS assessments for a number of important chemicals, in
some cases for more than a decade.
In addition to being inconsistent with agency guidance,
presentation of only a conservative default approach when there
is a viable alternative provides the decision-maker with an
inaccurate characterization of risk that compromises his
ability to make informed risk management decisions.
In my opinion, IRIS assessments currently do not provide an
objective and transparent characterization of the potential
risks associated with chemical exposure. The inadequacy of the
risk characterization in IRIS assessments, coupled with the
sole use of conservative default approaches, hampers the
ability of decision-makers to make informed risk management
decisions and gives the public an inaccurate impression of
their potential risks from chemical exposure. I believe that
this deficiency could to a large extent be addressed by
assuring that IRIS assessments adhere to the risk assessment
principles elaborated in the OMB memorandum in the information
quality principles.
Thank you.
[The prepared statement of Mr. Clewell follows:]

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Mr. Shimkus. Thank you. Now, I would like to recognize Mr.
Cook for 5 minutes, sir.

STATEMENT OF JERRY A. COOK

Mr. Cook. My name is Jerry Cook. I am the technical
director of Chemical Products Corporation, a small 78-year-old
Georgia corporation which employs about 200 people in
Cartersville, Georgia, which is in the metropolitan Atlanta
area, on the fringe I guess you would say. We are the last U.S.
producer of barium chemicals and I have been dealing with
barium toxicology and regulation for more than 28 years. I
joined Chemical Products in late October 1982 as technical
director.
The IRIS database is supposed to determine sound science
concerning the toxicology of chemicals to guide EPA's
regulatory activities as we have heard today. If IRIS
functioned properly, that could be used as a basis for sane
regulation of various chemicals in the environment.
Unfortunately, in the case of the IRIS barium file, I have
found that the IRIS chemical managers and their superiors were
not nearly as interested in sound science as they were in
bureaucratic expediency. They simply did not want to hear sound
science if it caused them to have to reevaluate the positions
that they had previously taken.
A brief history of barium regulation is as follows: in 1975
in the statement of basis and purpose for the national interim
primary drinking water regulations, under barium, EPA stated,
``No study appears to have been made of the amounts of barium
that may be tolerated in drinking water or of effects from
prolonged feeding of barium salts from which an acceptable
water guideline may be set.'' They arbitrarily chose a value at
that time based on the hypothesis that perhaps barium in
drinking water could cause a small but significant increase in
blood pressure and that that would be a danger to those already
suffering from high blood pressure. That was a hypothetical
effect that they derived from the fact that acute toxicity from
barium salt ingestion does include heart effects including
hypertension for the period of time until the barium is cleared
from the body.
The barium chemicals manufactured by Chemical Products
Corporation are used in the ceramics industry to manufacture
bricks and tiles, in the manufacture of luminous paints for
highway signage and airport striping, and in heat treating of
high-strength steel and the manufacture of catalysts. Many of
our customers are small and medium-sized U.S. companies which
are literally fighting for survival. Our customers tell us that
the costs associated with retroregulation of barium are a
substantial burden on them.
In our efforts to change the retroregulation of barium, the
IRIS determination of what was considered a safe level was
cited as the reason why the retroregulations were not going to
change. So that is how IRIS functions. IRIS is the basis upon
which regulatory decisions are made. If the science in IRIS is
bad, the regulatory decisions are going to be bad.
The CEO of Summitville Tile, one of our customers, asked me
to convey the following message to the members of this
committee. ``The overregulation of American industry is making
it increasingly more difficult for American manufacturers to
compete in today's global economy. Summitville Tiles is a case
in point. It is a 100-year-old manufacturer of quarry tile and
brick products based in Eastern Ohio. In recent years, it has
had to close 2 tile manufacturing facilities and 16
distribution centers, laying off over 450 employees.
Summitville Tile is today one of the last American tile
companies to remain in business. In fact, it is the only
remaining charter member of the tile industry's National Trade
Association, the Tile Council of North America. With foreign
imports now comprising approximately 80 percent of the U.S.
domestic tile market, the last thing that the tile industry
needs is more regulations. What is needed more than anything
else is regulatory relief.''
I think that sums up the feeling of many of the small and
medium-sized manufacturers in this country today. As a small or
medium-sized company, they are really not equipped to deal with
unnecessary regulatory burdens, and I think that that is
exactly how I would characterize the regulation of barium
because when a sound scientific study became available in 1994,
when the NTP published a lifetime study of the effect of barium
on rats and mice, IRIS greatly resisted acknowledging that
study because it did not find the effect that was listed in
IRIS. It did not find increased blood pressure. It instead
found at much higher levels that barium would have an effect on
the kidneys but the levels to find that effect were orders of
magnitude higher than the level that was promulgated in IRIS.
Let me tell you a little bit about barium if I may. Barium
is an alkaline earth metal, one of the group which includes
magnesium and calcium. It is not carcinogenic and barium is
rapidly eliminated from the body. In cases of acute barium
ingestion, the effects are usually gone within a week. Barium
is widely dispersed in the natural environment in the mineral
barite, barium sulfate, which is insoluble in water and acids.
Because it is insoluble, barium sulfate is not toxic. This is
the chemical administered as an x-ray contrast medium for
gastrointestinal x-rays. The infamous barium meal, I have never
had one, but I understand it is not particularly tasty. It
doesn't matter which end you put it in, it works for
gastrointestinal x-rays.
If a large amount of soluble barium is ingested or inhaled,
it is toxic because it temporarily interferes with the body's
cellular potassium transport. EPA's IRIS database deals with
chronic toxicity, which is a different situation. It is smaller
amounts of a chemical consumed daily for many years over a
lifetime. There is no known instance of any chronic toxic
effect in a human due to barium and no animal studies were
available as I read to you when EPA began regulating barium in
the mid-1970s.
Mr. Shimkus. Mr. Cook, I did tell folks they could go over
5. You are almost at 3 minutes over that so if you can kind
of----
Mr. Cook. Yes, sir. I appreciate it very much. I think you
have gotten the gist of my situation.
Mr. Shimkus. We have and we will follow up with questions.
Mr. Cook. Thank you.
[The prepared statement of Mr. Cook follows:]

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Mr. Shimkus. Thank you.
The chair now recognizes Dr. Burke for 5 minutes.

STATEMENT OF THOMAS A. BURKE

Mr. Burke. Thank you, Mr. Chairman. I appreciate this
opportunity. I am Tom Burke and I am the associate dean and a
professor at the Johns Hopkins School of Public Health, I also
direct the Johns Hopkins Risk Sciences and Public Policy
Institute, I served as a member of the Board on Environmental
Sciences and Toxicology at the National Academy, I am a member
of the EPA Science Advisory Board, and I chaired the National
Academy report Science and Decisions, which really took a hard
look at risk assessment practices at the EPA.
Perhaps most relevant to today's hearing, though, is I have
served as a state official. I was the director of the Toxics
Program, the director of Science and Research at the New Jersey
DEP, and the deputy health commissioner in charge of
environmental issues in that State. So I worked closely with 4
governors on very challenging issues, responding to public
health emergencies, which ranged from water contamination to
contamination of our beaches to food contamination to the
cleanup of hazardous waste sites.
So as a frontline health official, I can tell you that risk
assessment is really important. We need information when things
bang in the night. And it is an essential tool for protecting
the public's health. IRIS has been a part of that. So I would
like to address 3 points today.
One is risk assessment itself as an important tool. Second
is the IRIS program, and the third I would like to say a little
bit about, Science and Decisions and the National Academy
recommendations to change the way we approach risk assessment.
So first, as I mentioned, risk assessment is really
important to public health officials and it is used by not just
EPA but public health agencies around the world. I have helped
most of our national agencies from DOD to USDA to use risk
assessment. And as a state official, I have worked with other
state officials in doing this. And EPA is recognized as
providing most of us with the gold standards for evaluating
hazards. Part of this is a tremendous use of the IRIS
documents, but unfortunately, there are inherent uncertainties.
And as you heard from the panel, there are lots of things
about toxicology and epidemiology that are uncertain and they
provide the basis for risk assessment. So for instance, does
cancer in laboratory animals necessarily mean that exposure
will cause cancer in humans? Or more appropriate perhaps in
some of the debates about IRIS, if you have 2 conflicting
studies, one says you see a health hazard and the other
doesn't, which one does EPA go with and how do you make that
decision? Well, there have been lots of arguments about this.
There is lots of uncertainty that has led to a very polarized
confrontation, as you might imagine. So I am no stranger to
this phenomenon called dueling risk assessments. An agency will
present their risk assessment and their approach to a problem
and there is the opposite approach. And we have this situation
where EPA is being called way to precautionary and industry's
risk assessments aren't listened to because they are seen as
not being protective of public health.
So the challenge before us is this process itself, how to
be more transparent, meet the needs of decision-makers, and
break the log jam we now have. Now, the IRIS program, as you
heard today, has a very unenviable task of synthesizing a lot
of scientific information, and it appears to be the program
everyone loves to hate. So they provide these very
comprehensive overviews of health effects and they weigh the
scientific evidence, and it is very important in determining if
we have hazards. Not surprisingly, this is controversial. They
are the starting point for many of the Agency's most difficult
decisions. They provide insight into the magnitude of risk but
they don't tell us how to manage risks.
I am very familiar with the challenges of IRIS and I
actually think the NAS report on formaldehyde provides a sound
roadmap for them to improve that.
Now, I would like to finish with a few words about risk
assessment. We have blurred the line today I think between risk
assessment and the IRIS hazard assessments. Risk assessment is
about decisions and should start with, as Science and Decision
lays out, the problem formulation making sure we ask the right
questions, including the assessment that looks at the various
options for control.
And finally, with risk management decision justification,
very important to this committee, is this decision justified,
particularly in light of costs? So I think just to kind of sum
up, the framework that Science and Decisions offers perhaps can
help us improve the application of IRIS and risk assessment and
risk management and consider the very important considerations
of economics and jobs.
So finally, can risk assessments work for jobs and the
economy? Well, in my experience as a state official in New
Jersey, a clean environment is definitely good for business,
just ask the resort owners of the Jersey Shore or the
businesses along the redeveloped Brownfields and the Hudson
River shoreline. Getting better solutions for environmental
problems goes well beyond IRIS and should focus on advancing
risk assessment to better inform our public policies.
Thank you for the opportunity to speak to you today.
[The prepared statement of Mr. Burke follows:]

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Mr. Shimkus. Thank you, Dr. Burke.
And now I would like to recognize myself for 5 minutes for
opening questions in this panel. I will start with Mr. Cook
because a lot of our focus here in this Congress has been on
the effects of regulations on jobs and the economy. We do want
to make sure that that is balanced, but we also, especially in
the environment that we are in, we know that excessive
regulations really are creating a burden.
You have highlighted some of those burdens in your opening
statement. If the chemicals you produce are not available, what
substitutes would be made?
Mr. Cook. In some cases, there would be substitutes
available. In other cases, I am not sure there would be. In the
case of the airport striping and signage, our barium carbonate
is formulated by 2 manufacturers in the United States into very
tiny barium glass beads. Barium gives that glass a very high
refractive index, so when light shines on a paint containing
these glass beads, it glows. I think that is a major safety
consideration for airports and certainly it helps visibility of
highway signs and probably has a safety impact there, too. I am
not sure what material other than lead--lead glass also has a
high refractive index.
Mr. Shimkus. Barium would probably be better than lead.
Mr. Cook. Given as I say there really is no chronic effect
to barium until you get to very, very high levels that are just
not found anywhere in nature.
Mr. Shimkus. And let us just talk through this. Also, you
opening statement mentioned if we are not certain that the IRIS
analysis is based upon credible sound science, what effect does
that have on you?
Mr. Cook. Well, for the past almost 29 years now, I have
been trying to effect a change in the regulatory limit. And as
I said, that regulatory limit was established back in the '70s
when there was no data. Unfortunately, when IRIS came along in
1987, by that point, EPA had funded two studies. One found a
slight but--they claimed--significant blood pressure increase
at low levels of barium in drinking water. The study in EPA's
own health effects research lab, giving the rats 10 times as
much barium for a longer period of time found no blood pressure
increase. EPA chose to go with this study that found the blood
pressure increase and said aha, here it is, once again, over-
precautionary. It was not a particularly good study. They
recognized that and yet they set their limits on that.
Mr. Shimkus. And there is terminology, abundance of
caution, at the different levels as the regulation moves
forward, and I think you are highlighting that.
Mr. Cook. Yes.
Mr. Shimkus. Dr. Honeycutt, in your written testimony, you
are pretty blunt. You say, ``because of the lack of scientific
defensibility and the implications of EPA's new chemical
assessments, we decided to develop our own chemical
assessments.'' Can you describe the scientific defensibility
that you refer to? Because I hear Mr. Cook talk about barium
and I am not sure anyone in essence disagrees with that
analysis, but can you talk about what you are referring to
here?
Mr. Honeycutt. Sure. There is no doubt that EPA comes up
with safe levels. I mean there is no doubt about that. The
question is can you have a higher level that is still just as
safe? And that is where you have to get away from default
procedures and actually look at how a chemical work in the
body. How does it work in the rat versus how does it work in
the human and then at what levels are they exposed to? Because
chemicals will exhibit different levels of toxicity depending
on the dose. A good example is Tylenol. Twenty tablets will
kill you, two tablets will cure your headache, a half a tablet
or a quarter of a tablet won't do anything to you that is an
adverse effect. So you have to look at those differences in
dose.
Mr. Shimkus. In your opinion, is the IRIS program receptive
to suggestions for program improvements to address this example
you just gave?
Mr. Honeycutt. Well, they actually have guidance on some of
the things that we are talking about. The problem is their
inconsistency in using their own guidance. They talk the talk
but when it comes to doing the assessment, they just revert
back to their old precautionary selves.
Mr. Shimkus. Thank you. My time has expired. And depending
upon how many people show up, we may go around a second time. I
know there is more I want to address.
So I would like to recognize Mr. Green for 5 minutes.
Mr. Green. Thank you, Mr. Chairman.
Both Houses of Congress seem to be interested in addressing
the IRIS recommendations whether it is strengthening IRIS or
suspending it. And our colleagues in the Senate sent a letter
to one of our first panelists calling for suspension of IRIS
assessments until the NAS recommendations can be incorporated.
On the first panel, we heard from Dr. Anastas and the NAS on
why such a suspension is not necessary and wouldn't protect
public health. Now, with this panel, we are fortunate to have
an expert on risk assessment who was quoted in that Senate
letter.
Dr. Burke, you are quoted as saying, ``A sleeping giant is
the EPA sciences on the rocks and if you fail you become
irrelevant.'' Would you explain that statement?
Mr. Burke. Sure, and thanks for asking that question. So
that statement was made at a meeting of the EPA Science
Advisory Board where we presented with the ORD vision for how
science will be conducted in the future. And knowing the
incredible pressures and having been on those frontlines,
applying science to society's problems, I issued that as a
warning statement. Obviously, there is lots of criticism; then
the credibility of science is really important.
So why is EPA in a crisis? Well, because of the incessant
attacks on their credibility not because they are not trying to
put together the best science and not because they don't have a
good Science Advisory Board that provides them, but I think it
is important to put that into context. EPA is under siege. The
very mission of protection of our environment is being
questioned, sometimes with good cause because of the economic
considerations. But I think there is a crisis. There is a
crisis in credibility and that roadmap of improving IRIS will
be a very important step toward addressing that crisis.
Mr. Green. OK. And you are familiar with the rider that I
mentioned and do you think that rider would strengthen the IRIS
program?
Mr. Burke. Unfortunately, I think it would be a disservice
to public health agencies throughout the country and even
perhaps the world and it would bring things to a halt in a way
that would not serve us well.
Mr. Green. OK. It seems there is a difference of opinion
among our panel members on IRIS assessments and what they
should be. Dr. Honeycutt suggested in his testimony the IRIS
assessment provides EPA's judgment in how much a chemical can
be in fish or apple juice for it to be considered safe, but
these evaluations require assessing that exposure, something
IRIS does not do. Dr. Burke, can you clarify the distinction
between assessing the hazard and assessing the risk?
Mr. Burke. Yes, so understanding the hazard it is like
knowing. So this is anthrax over here and this is bad stuff,
can cause a real problem and it can cause problem at different
levels. So it allows us to understand what the risks might be
to people who are exposed. That is very different than the
problem-oriented process of risk assessment that says we have a
facility here that has a problem and potentially emitting
things into the environment. How do we evaluate what is
acceptable in terms of a response to manage that risk. So the
risk assessment is site-specific; it is population-specific,
very different than just identifying the hazard and evaluating
the epidemiology and toxicology.
Mr. Green. So there is a difference between the risk
assessment and what risk is acceptable?
Mr. Burke. Yes. And the hazard assessment will never tell
you what risk is acceptable. That is a societal issue. It can
consider social issues. There are lots of things that we don't
regulate to very low levels because they are naturally
occurring, and it is a policy question, not a science question
except ability of risk. But understanding a hazard, that is all
about good science.
Mr. Green. Well, here we understand asbestos is a toxic
substance but you can go out in some places and dig up asbestos
since it is a rock. And we know we can't prohibit it because
you can be exposed by just digging it up. Although asbestos for
decades was used very substantially to retard fire risks, so an
assessment of the danger and also what could be acceptable if
you encapsulate it and do lots of things you can deal with
that.
Dr. Honeycutt, I want to thank you for appearing before the
committee, and you have heard, I have worked with TCEQ over the
years and TCEQ actually alerted our office because for years we
have had a heightened dioxin level in upper Galveston Bay and
the Houston Ship Channel and most of my industries are getting
blamed for it. And there was some concern because we couldn't
quantify it until TCEQ did. Can you tell us what efforts TCEQ
has taken in regard to dioxin just as a substance? Like I joke
I want dioxin, I want white shirts, but I also know that I
don't want to drink it. So if you can tell us what TCEQ in
Texas has done with it.
Mr. Honeycutt. Yes, sir. Thank you. I am very familiar with
the San Jacinto pit site. We have developed our own policy-
based number that we have used over the years for dioxin, and
as I mentioned in my testimony, we are developing our own
procedures for coming up with these toxicity values that has
been through a peer review and that is out for public comment
right now. So once that is finalized, we are going to run
dioxin through a process and see what our number looks like. So
we are actively looking at that. I can't tell you right now
where the number will come, whether ours is more or less or
higher or lower than EPA's but we are going to be actively
involved in that.
Mr. Green. OK. Is there going to be any conflict between
when EPA is coming out in 2012 or will the TCEQ's be earlier
than, you know, a year from now?
Mr. Honeycutt. It won't be earlier than a year from now
definitely.
Mr. Green. OK. It would be good to have two different
assessments because, one, that is how you get what we can do
with the risk and also I know I am over time but I appreciate
your testimony that having spent 20 years in the Texas
legislature and getting mad at EPA on a regular basis, we also
recognize, as you said in your testimony, we sit down and can
work things out but sometimes we have to lower the decibel
level to get there.
So thank you, Mr. Chairman.
Mr. Shimkus. The gentleman yields back his time.
The chair recognizes the gentleman from Louisiana, Mr.
Cassidy, for 5 minutes.
Mr. Cassidy. Thank you. I am an erstwhile academic so I
will speak to Dr. Clewell and Dr. Burke because clearly as I
gather IRIS is supposed to be here to use science to inform
policy. The concern, though, is that policy is manipulating
process in science to achieve an advocacy as opposed to
achieving truth, truth being the highest calling of science.
Fair statement? And that is, if you will, the question before
us.
Now, Dr. Clewell, when I read yours that there is clear
bias towards presenting evidence that supports the selection of
a default linear approach even when there is support for a
nonlinear approach in the scientific community, if I was co-
writing a paper with a medical student and she brought
something to me that had only one explanation even though I
knew that there was an alternative explanation which she does
not address, I would give her a mulligan. I would say you are a
medical student; you need to learn to do better. Bring it back
discussing the alternative explanation and use this as a
teaching moment. When EPA is using it to drive public policy,
my blood pressure goes up. I must have just taken a boatload of
barium because, you know, why in the world are we making
decisions that affect an incredible number of jobs on something
which doesn't have a plausible alternative explanation. So you
have made your point.
Let me ask Dr. Burke whether or not you disagree with the
point Dr. Clewell made but by the way is a similar point to
what NAS made that the neurobiological effects of the
formaldehyde could be attributed to other things, which the
thousand-page document did not discuss. So Dr. Burke?
Mr. Burke. I don't think we fundamentally disagree that EPA
should present as comprehensive a picture as possible with the
alternatives. I think we probably disagree in the fundamental
mission of EPA and there in my testimony----
Mr. Cassidy. Can I stop you for a second?
Mr. Burke. Yes.
Mr. Cassidy. Because I am actually talking about not EPA
but IRIS.
Mr. Burke. OK.
Mr. Cassidy. IRIS and a thousand-page document presumably
presenting a comprehensive discussion----
Mr. Burke. Right.
Mr. Cassidy [continuing]. Did not present a plausible
alternative explanation that NAS came up with.
Mr. Burke. Right.
Mr. Cassidy. Now, this is not, you know, industry. This is
NAS.
Mr. Burke. Right.
Mr. Cassidy. And so you open a thousand-page document, IRIS
did not discuss it. It has to beg the question have they moved
beyond advocating science for truth to selective presentation
of science to pursue policy?
Mr. Burke. OK. Well, again, not being part of the IRIS
program and not being part of that review, I know that the
standard default that not just EPA but public health officials
use, again, throughout the world particularly for carcinogens
is the linear default, that we are not quite sure because
genetic damage can happen at very low levels, just how low that
straight line might go. However----
Mr. Cassidy. Now, that I have to say surprises me because
we know that a 20-pack a year history of cigarette smoking is
strongly related to a risk of something less is a threshold
effect. Indeed, Dr. Anastas spoke about how--I have it written
down here someplace and of course I have lost it--that they
look for a dose-related effect.
Mr. Burke. Yes.
Mr. Cassidy. So that would be a nonlinear effect. I am not
sure why we are still mired in something conceived of 3 decades
ago as defining how we should approach a problem in this year.
Mr. Burke. Well, I think it is the strength of evidence,
and when we are looking at hormonal effects and we are looking
at neurological effects on the unborn, the fundamental question
is, a very important one, shouldn't we present the whole
picture about what the alternatives may be. But that may not
change the public health decision that where there is
uncertainty we have to make decisions.
Mr. Cassidy. But my concern is apparently they are not
presenting the whole picture which in effect skews the----
Mr. Burke. That is where I think we agree.
Mr. Cassidy. Excuse the assumption. Dr. Clewell, I am kind
of speaking for you. Could you speak for yourself?
Mr. Clewell. Thank you, sir. I am particularly troubled
because I worked closely with William Farland when they were
developing the cancer guidelines trying to change from the old
way of doing things with just a default. And the cancer
guidelines was important because it was the first time that
priority was given to a chemical-specific decision that did not
rely on the default and a justification was required that there
was insufficient data to support using a default. But in recent
years there has been use of 1968 guidelines. It is a default.
They don't demonstrate a balanced presentation of the different
alternatives that are being discussed in the scientific
community. They paint a picture of evidence supporting the
default.
Mr. Cassidy. That is either suggesting incompetence or it
is suggesting the pursuit of a political agenda.
Mr. Clewell. Absolutely not incompetence. They are very
competent people. I believe that they are public health
professionals who are very concerned about public health and
want to make sure they are conservative. And in trying to make
sure that the protection is provided, they may not provide
complete descriptions of alternative approaches that would
generate a lower-risk estimate.
Mr. Cassidy. That is a patronizing approach to the use of
truth in science. And I as a person who is sitting on here
trying to make an informed decision am offended that they
assume I don't have the intellectual firepower to figure it
out. And that is a disservice to the American people.
Mr. Clewell. Actually, the Office of Water has the same
problem. They are pretty much hamstrung by the arsenic risk
assessment and decisions they would like to make like saying
you don't have to clean up the entire western country of
arsenic in soil and river water are difficult to make when
there is only a linear risk estimate.
Mr. Cassidy. I agree with Dr. Burke that there is indeed a
threat to IRIS's reputation and I think we are seeing it in
terms of an uncovering of how they present facts. I yield back.
Mr. Shimkus. The gentleman yields back his time.
For the sake of getting my colleagues angry at me, I would
like to go to a second round. I think the panel is well
informed. We are learning a lot. The risk will be members may
come back which might hold you a little bit longer, but I would
like to go a second round if that is oK with our guests and my
colleagues here. If no objection, then so ordered. We will go
to a second round, 5 minutes each. And I may not take my whole
5 minutes, but with that, I will recognize myself.
And this is just a great debate. My concern is an
overabundance of caution at IRIS and an overabundance of
caution at EPA with the policymakers could create job loss,
economic dislocation, and movement of production overseas. So
we have got to get the science right and I don't question the
public health officials' intent to protect human health. I do
agree that this debate on dosage and what is really harmful is
very, very important.
So with that, Dr. Burke, I want to address just one
question on the delay because the question is what would you
deem more harmful to human health and the economy? A 1- or 2-
year delay in an assessment that would ensure the scientific
robustness of the result or an assessment based on poor
processes that is pushed through with questionable science?
Mr. Burke. I think we owe it to the American public, I
think we owe it to the scientific community to use the data
appropriately and to synthesize the scientific information to
inform decisions. However, having been in emergency situations
where the data wasn't perfect, for instance, the trailers in
Louisiana where the data on formaldehyde weren't perfect, I
worked with the CDC to try and make sure we didn't have acute
exposures. So sometimes in public health we have imperfect
information. However, I agree with you, Mr. Chairman, that it
would be better to do it right than to destroy the credibility
of the process.
Mr. Shimkus. And that is this whole debate from the Senate,
from what we did on the rider to say let the National Academy
of Sciences' report be, you know, followed before we continue
to move forward just so we get it right. But the great thing
about a lot of things we do on this committee and on our health
subcommittee is that people in this arena are public servants
and want to do things right. But again we wanted to raise that
issue.
To Dr. Honeycutt, I raised this in maybe my opening
statement or the first round. We have talked about it before
and we just mentioned it with the water and arsenic in the
Southwest. I remember it well because one of my colleagues,
Heather Wilson, always talked about that, arsenic levels in
drinking water although it was naturally occurring. So with
that, this question: In your opinion are there broader economic
consequences associated with publishing an IRIS value that is
lower than background levels, and if so, what impact do you
feel it has on the jobs in the economy?
Mr. Honeycutt. Oh, absolutely there is an impact. Two real
quick examples, one is mercury. EPA is actually, they are
outliers from the rest of the world and what is a safe level of
mercury in fish. All other regulatory agencies have higher safe
levels. And they came home to Texas just a few weeks ago.
Mr. Shimkus. Let me interrupt. Is that true in the European
standards?
Mr. Honeycutt. Yes, the World Health Organization has a
higher safe level for mercury in fish than EPA does.
Mr. Shimkus. That is funny. I never hear my colleagues
mention that when we debate that issue.
Mr. Honeycutt. But Lumina Energy laid off 500 people just a
couple of weeks ago. So it does have direct or indirect--it
depends on how you look at it--economic consequences.
And another example is the arsenic that you are talking
about. In Texas, there are a lot of really small locally owned
utilities that won't be able to meet this, so they are going to
close down. And so people then will have to drill their own
water wells and that is a real public health concern because
that water won't be tested or monitored and they are going to
be at their own risk that the public water systems won't be
able to provide that level of safety.
Mr. Shimkus. And let me just finish with this. Mr. Cook
talked about barium quite a bit in his analysis and his
response. His statements on barium and the health risk--and I
kind of assumed everyone sort of agreed with that analysis--can
you go on record saying you agree with Mr. Cook on his analysis
on barium?
Mr. Honeycutt. Yes, sir. Barium in the grand scheme of
things is not a very toxic chemical at all.
Mr. Shimkus. Dr. Clewell?
Mr. Clewell. Yes, I agree.
Mr. Shimkus. Dr. Burke?
Mr. Burke. I really don't know the issue. I will have to--
--
Mr. Shimkus. That is fine. That is fine. And that is why I
wanted to clarify because I did make an assumption. I didn't
want to do that.
So I am going to yield back 18 seconds and ask my
colleague, Mr. Green, to be recognized for 5 minutes.
Mr. Green. Thank you, Mr. Chairman.
Dr. Burke, in listening to my colleague from Louisiana, Dr.
Cassidy, and I think your comments sound like it blurs the line
between the mission of IRIS, which is to assess the risk and
not the issue of regulations, which is the management of that
risk, which is EPA's job. I guess there may be some concern
that by the assessment from IRIS, it may raise the level of
concern but, you know, like we have heard from Dr. Honeycutt,
you know, IRIS is supposed to give the assessment but the risk
is an EPA decision and not necessarily what may come out of the
study.
For example, the water, you know, obviously water we need
for our lives, but if you take it from a fire hose, you are
going to drown. And so there is a reasonable amount that you
can have that is necessary but it is, you know, too much of
anything is bad.
And Dr. Burke, naturally occurring levels of chemicals,
they are not always safe. A good example of arsenic in water, I
can tell you in West Texas and all over the West there are
waterholes or water that people should not drink and know they
shouldn't drink because of whatever the chemical is in there
that are naturally occurring. So just because they are
naturally occurring doesn't mean it is safe. You just have to
have a certain level of it I guess to keep it. And is that
something we are continually confused, the difference between
assessment and risk?
Mr. Burke. Well, it is a very important point. We can't
possible clean up the Earth's crust, nor can we regulate
volcanoes for spewing mercury. And we have these naturally
occurring materials and we have to balance that in the
decision-making. On the other hand, what we know about arsenic
comes from actually naturally occurring contaminated wells in
other parts of the world where people drank very high amounts
and had acute effects as well as cancer effects. And so it
comes down to being reasonable about how we approach regulation
with the right information on the public health effects to help
us make those decisions.
Mr. Green. OK. You know, I have announced where I come
from. I have the biggest petrochemical complex in the world in
our district--in the country, second largest in the world, and
so I guess my focus is on the relationship. Dr. Burke, as a
former state regulator and you have seen the risk assessment
and effective risk management, what effect can it have on the
jobs? Every product we make in the Houston Ship Channel, it
wouldn't be made if somebody didn't need it. I mean industries
don't do that. They don't make any money on it. So someone
needs it but it depends on how you make it and how that product
is used, whether it be in gasoline or some other additive or
something else.
But is there a direct correlation between effective risk
management and the impact on jobs and the economy, which is I
think what the whole subcommittee was getting at?
Mr. Burke. I think that is a very important point in major
regulatory decisions. I am not an economist. I can only speak
from experience, and clearly there are regulations that have
added cost to industry and therefore may impact jobs and may
impact the general public as well. But as we recommended in
Science and Decisions, that should be part of the deal in
conducting the assessment to make sure you are making the right
risk management choice.
That doesn't change what happens in the epidemiologic
studies or in the mice, but we can take that data and if it is
properly presented make good decisions. So in my experience
again, New Jersey, very industrialized, lots of heavy industry,
lots of refineries, pollution was much worse for jobs and
unsafe workplaces were much worse for jobs than environmental
regulations. However, I completely understand that analyzing
the impacts on the economy on jobs should be part of the
decision process.
Mr. Green. Thank you, Mr. Chairman. And following your
lead, I will yield back my 46 seconds.
Mr. Shimkus. I thank my friend.
The chair now recognizes the gentleman from Louisiana, Mr.
Cassidy, for 5 minutes.
Mr. Cassidy. Again, I am learning a heck of a lot in this
meeting, so thank you all for all being here. I am struck how
sometimes processes used to manipulate the response to the
findings. Now, Dr. Honeycutt, I am impressed that you all--I
haven't read about a regression coefficient since I have been
here, you know, been practicing whatever, and you all did an
analysis--now, that is a 1,043-page document which is
stultifying, redundant, and sometimes irrelevant, and yet you
had to do all 1,043 pages. Now, it makes me think that it would
be incredibly time-intensive, resource-intensive to really do
an adequate review. If you have a statistician doing a
regression coefficient on nasopharyngeal cancer mortality to
criticize or critique the method by which they determined
incidents, you got some money tied up in staff working on this
project. Fair statement?
Mr. Honeycutt. Yes, sir, it is.
Mr. Cassidy. Now, if it is 1,000 pages do they give you 120
days or--do you see what I am saying?
Mr. Honeycutt. Yes, sir. No, you get the same amount of
time. And the deal with IRIS is you don't get to give input on
the front end; you give input on the back ends after EPA has
already--the train has left the station and they are
recalcitrant to change their mind. So that is what you are left
with.
Mr. Cassidy. I see everybody nodding their head yes. Now,
that is disturbing because again if we have a premise which I
think you all agree with is that sometimes they are not given
the complete picture but at the same time it takes an
incredibly intensive process in order to uncover how that is
not complete, then you are going to have policy decisions made
upon something which may, some cynics would say, deliberately
made onerous upon which to review. Again, it goes back to is
science deriving policy or is science being presented in such a
way as to serve as advocacy for a policy end?
Now, we heard in the first panel and NAS and others
criticize the fact that OMB was allowed to at times review the
EPA documents in order to say, oK, wait a second, time out, let
us look at this. But Dr. Burke, I had a sense from you that in
this whole analysis needs to be some sort of cost-benefit
return on investment, what is the true sort of economic cost?
Here we have people losing their jobs for something which is
nominally and maybe even speciously toxic. Now I am thinking
maybe OMB needs to be involved. I mean maybe there needs to be
a delay if once the train has left the station you have so
little time to review something which is so complex to review.
Dr. Clewell, what would be your comments on that?
Mr. Clewell. I am not what sure what would be the level of
oversight, but I do believe that OMB plays an important role in
verifying that the agencies are doing the best job to make the
process reviewable, and so I would be in favor of there being a
better dialogue between OMB and EPA so that that could be
accomplished.
Mr. Cassidy. And in fairness, I think the critique is that
they should be more transparent in their questions, but I think
there was also a criticism as regards sending EPA back to
repeat an analysis. What I have learned today is that maybe EPA
does need to be sent back to be more inclusive in their
analysis. I am feeling more sympathy for OMB right now. So let
us see if there is anything else in this.
Now, who is a chemist? Anybody up there a chemist? The idea
that Dr. Anastas said that with green chemistry they know the
actual effect of every chemical compound is going to have upon
skin, respiratory system, digestive system, et cetera seems to
me like the epitome of intellectual kind of hubris.
Mr. Clewell. It might have been somewhat hyperbolic. I
think he is trying to indicate that there is an ability--and
drug companies use it all the time--to try to estimate activity
from structural properties and that is trying to be harnessed.
They are trying to harness that in order to develop safer
compounds.
Mr. Cassidy. There is also the presumption, though, that
you can make everything inert, and I am not sure you can make
life inert.
Mr. Clewell. I am fairly confident you cannot.
Mr. Cassidy. Yes, so I agree with that.
Let me finish up. I will also yield back by saying to Mr.
Cook, Mr. Cook, you are the only guy in this whole room that
creates jobs, so on behalf of the American people, thank you
for creating jobs, and I am very sorry for the impediments put
in front of you by the Federal Government. We sincerely wish we
could be creating a lot more jobs.
Thank you. I yield back.
Mr. Shimkus. The gentleman yields back. At this time, the
chair now recognizes Mr. Harper from Mississippi for 5 minutes.
Mr. Harper. Thank you, Mr. Chairman. And thank you,
witnesses, for being here today and giving your insight into
what is continuing to be a very important issue for us.
And I will start if I may with you, Dr. Honeycutt, if I
could just with some follow up questions on what you had
earlier.
And I have to ask what types of evidence are necessary to
establish a causal relationship between exposure to a substance
and some health effect or health risk. What are you looking
for?
Mr. Honeycutt. Yes, that is a very good question and it is
well known. It is called the Hill criteria for causation. It is
well documented. What you need to do is show that a chemical
can cause the effect that you are looking at and it can cause
it at the concentrations you are looking at and that it is
reproducible. It happens over and over again, not just one time
in one study, and that the effect happens after the exposure.
Sometimes we regulate chemicals on if the effect happens before
the exposure.
Mr. Harper. Um-hum.
Mr. Honeycutt. And that it is not just a background
occurrence, the health effect that you are looking at, that if
there is an increased incidence of cancer in this community
that it is indeed increased, it is well above background, not
just a tiny bit above background.
Mr. Harper. Are you always able to figure those problems
out? It is a search I am sure many times.
Mr. Honeycutt. Sometimes it happens very easily and
sometimes it is harder. The health effects of ozone are based
on a 1 to 4 percent increase in premature mortality, whatever
that is, and how do you quantitate that? It is very, very
difficult. And in studies the EPA use, you can't quantitate
that.
Mr. Harper. And is it true that substances at a high level
which may create that risk, they may be safe, perhaps even
necessary at a low level. Would that be certainly true to say?
Mr. Honeycutt. Absolutely. Every vitamin you take, most of
the minerals in your food that you eat, some of them are
essential nutrients that if you get too much of them, they will
kill you.
Mr. Harper. If I could, Dr. Cook, I wanted to ask you----
Mr. Cook. Mr. Cook.
Mr. Harper. Mr. Cook, I am sorry. That just shows you the
respect that we have for your being here today.
Earlier today we had on the first panel--I believe you were
in the room when they were here--Mr. Trimble from GAO testified
on panel one that the EPA should take the IRIS program back in-
house to avoid meddling from OMB or other departments or
agencies. Based upon your experience, do you think that is a
wise move?
Mr. Cook. If it had not been for OMB's implementation of
the Information Quality Act in 2002, I do not believe we ever
would have seen IRIS recognize the true chronic effect from
barium. Four years after the 1994 NTP study, the definitive
study was published on barium chronic toxicity, the revised
IRIS assessment in 1998 still argued and ignored the sound
scientific evidence that there was no blood pressure effect
from small low levels of barium, if it had not been for OMB's
intervention, I don't think we ever would have gotten any
response from EPA to make the change that was finally put into
effect in IRIS in 2005.
Mr. Harper. Thank you. Also, Mr. Cook, another question I
have is, you know, some concerns about IRIS relate to cleanup
levels that must be attained under our federal environmental
laws. Do you have any experience where IRIS's uncertainty or
inappropriate values caused a hazardous waste cleanup to either
stall or be delayed or the costs rise substantially?
Mr. Cook. We are still in the throes of determining
financial responsibility for a superfund cleanup that is still
ongoing in North Carolina. Ward Transformer Company operated
just near the Raleigh, North Carolina, Airport rebuilding
transformers from 1963 until they finally went out of business
I think in 2004. They were designated as a superfund site, the
plant site there I think in about 1979. Some of the potentially
responsible parties negotiated a settlement with EPA to clean
up the actual plant site. The contamination is all PCBs from
transformer oil. And they were given a choice at the time that
they came to a settlement with EPA of either cleaning up to a
25-parts-per-million standard or a 1-part-per-million standard.
The consultant that was working with them reported in the
document that I obtained from Region 4 EPA that the choice to
clean up to a very stringent 1-PPM standard was made primarily
because of a fear that EPA would come back later and require a
further cleanup because the safe level had not been clearly
defined in IRIS and they were not sure what might come down the
pike.
Mr. Harper. So an abundance of caution made them do that at
a much greater cost than probably what was necessary.
Mr. Cook. Yes. I think they even ended up spending about 2-
1/2 times what they thought they were going to spend to clean
up to a 1-PPM standard.
Mr. Harper. I thank each of you and I yield back.
Mr. Shimkus. I thank my colleagues for joining and for you,
thank you for putting up with 2 rounds of questions from us. We
really appreciate it. And you can tell from the questions by my
colleagues that they were sincere in trying to work through
this process.
I want to put on the record that the record will be open
for 10 days. You all may see some additional written question
as the first panel might from us. If you could answer those
questions in writing and send them back within that period of
time or as soon as possible, we would greatly appreciate that.
We do appreciate your time and I adjourn the hearing.
[Whereupon, at 12:49 p.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]

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