[House Hearing, 112 Congress]
[From the U.S. Government Publishing Office]
EPA'S IRIS PROGRAM:
EVALUATING THE SCIENCE AND PROCESS
BEHIND CHEMICAL RISK ASSESSMENT
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON INVESTIGATIONS AND
OVERSIGHT
COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED TWELFTH CONGRESS
FIRST SESSION
__________
THURSDAY, JULY 14, 2011
__________
Serial No. 112-30
__________
Printed for the use of the Committee on Science, Space, and Technology
Available via the World Wide Web: http://science.house.gov
EPA'S IRIS PROGRAM: EVALUATING THE SCIENCE AND PROCESS BEHIND CHEMICAL
RISK ASSESSMENT
EPA'S IRIS PROGRAM:
EVALUATING THE SCIENCE AND PROCESS
BEHIND CHEMICAL RISK ASSESSMENT
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON INVESTIGATIONS AND
OVERSIGHT
COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
HOUSE OF REPRESENTATIVES
ONE HUNDRED TWELFTH CONGRESS
FIRST SESSION
__________
THURSDAY, JULY 14, 2011
__________
Serial No. 112-30
__________
Printed for the use of the Committee on Science, Space, and Technology
Available via the World Wide Web: http://science.house.gov
----------
U.S. GOVERNMENT PRINTING OFFICE
67-255 PDF WASHINGTON : 2011
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Washington, DC 20402-0001
COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
HON. RALPH M. HALL, Texas, Chair
F. JAMES SENSENBRENNER, JR., EDDIE BERNICE JOHNSON, Texas
Wisconsin JERRY F. COSTELLO, Illinois
LAMAR S. SMITH, Texas LYNN C. WOOLSEY, California
DANA ROHRABACHER, California ZOE LOFGREN, California
ROSCOE G. BARTLETT, Maryland DAVID WU, Oregon
FRANK D. LUCAS, Oklahoma BRAD MILLER, North Carolina
JUDY BIGGERT, Illinois DANIEL LIPINSKI, Illinois
W. TODD AKIN, Missouri GABRIELLE GIFFORDS, Arizona
RANDY NEUGEBAUER, Texas DONNA F. EDWARDS, Maryland
MICHAEL T. McCAUL, Texas MARCIA L. FUDGE, Ohio
PAUL C. BROUN, Georgia BEN R. LUJAN, New Mexico
SANDY ADAMS, Florida PAUL D. TONKO, New York
BENJAMIN QUAYLE, Arizona JERRY McNERNEY, California
CHARLES J. ``CHUCK'' FLEISCHMANN, JOHN P. SARBANES, Maryland
Tennessee TERRI A. SEWELL, Alabama
E. SCOTT RIGELL, Virginia FREDERICA S. WILSON, Florida
STEVEN M. PALAZZO, Mississippi HANSEN CLARKE, Michigan
MO BROOKS, Alabama
ANDY HARRIS, Maryland
RANDY HULTGREN, Illinois
CHIP CRAVAACK, Minnesota
LARRY BUCSHON, Indiana
DAN BENISHEK, Michigan
VACANCY
------
Subcommittee on Investigations and Oversight
HON. PAUL C. BROUN, Georgia, Chair
F. JAMES SENSENBRENNER, JR., DONNA F. EDWARDS, Maryland
Wisconsin ZOE LOFGREN, California
SANDY ADAMS, Florida BRAD MILLER, North Carolina
RANDY HULTGREN, Illinois JERRY McNERNEY, California
LARRY BUCSHON, Indiana
DAN BENISHEK, Michigan
VACANCY
RALPH M. HALL, Texas EDDIE BERNICE JOHNSON, Texas
C O N T E N T S
Wednesday, April 13, 2011
Page
Witness List..................................................... 2
Hearing Charter.................................................. 3
Opening Statements
Statement by Representative Paul C. Broun, Chairman, Subcommittee
on Investigations and Oversight, Committee on Science, Space,
and Technology, U.S. House of Representatives.................. 17
Written Statement............................................ 18
Statement by Representative Donna F. Edwards, Ranking Minority
Member, Subcommittee on Investigations and Oversight, Committee
on Science, Space, and Technology, U.S. House of
Representatives................................................ 19
Written Statement............................................ 21
Witnesses: Panel I
The Honorable Paul Anastas, Assistant Administrator, Office of
Research and Development, U.S. Environmental Protection Agency
Oral Statement............................................... 23
Written Statement............................................ 25
Mr. David Trimble, Director, Natural Resources and Environment,
U.S. Government Accountability Office
Oral Statement............................................... 28
Written Statement............................................ 30
Dr. Jonathan M. Samet, MD, MS, Professor and Flora L. Thornton
Chair, Department of Preventive Medicine, Keck School of
Medicine, University of Southern California; and Chair,
Committee to Review EPA's Draft IRIS Assessment of
Formaldehyde, National Research Council, The National Academies
Oral Statement............................................... 40
Written Statement............................................ 36
Witnesses: Panel II
The Honorable Calvin Dooley, President and Chief Executive
Officer, American Chemistry Council
Oral Statement............................................... 62
Written Statement............................................ 63
Ms. Rena Steinzor, Professor, University of Maryland School of
Law, and President, Center for Progressive Reform
Oral Statement............................................... 66
Written Statement............................................ 67
Dr. Gail Charnley, Principal, HealthRisk Strategies
Oral Statement............................................... 124
Written Statement............................................ 125
The Honorable J. Christian Bollwage, Mayor, City of Elizabeth,
New Jersey
Oral Statement............................................... 127
Written Statement............................................ 128
Appendix I: Answers to Post-Hearing Questions
The Honorable Paul Anastas, Assistant Administrator, Office of
Research and Development, U.S. Environmental Protection Agency. 144
Mr. David Trimble, Director, Natural Resources and Environment,
U.S. Government Accountability Office.......................... 166
Dr. Jonathan M. Samet, MD, MS, Professor and Flora L. Thornton
Chair, Department of Preventive Medicine, Keck School of
Medicine, University of Southern California; and Chair,
Committee to Review EPA's Draft IRIS Assessment of
Formaldehyde, National Research Council, The National Academies 171
The Honorable Calvin Dooley, President and Chief Executive
Officer, American Chemistry Council............................ 176
Dr. Gail Charnley, Principal, HealthRisk Strategies.............. 262
The Honorable J. Christian Bollwage, Mayor, City of Elizabeth,
New Jersey..................................................... 285
Appendix II: Additional Material for the Record
Representative Larry Bucshon, Subcommittee on Investigations and
Oversight, Committee on Science, Space, and Technology, U.S.
House of Representatives....................................... 306
EPA'S IRIS PROGRAM:
EVALUATING THE SCIENCE AND PROCESS
BEHIND CHEMICAL RISK ASSESSMENT
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THURSDAY, JULY 14, 2011
House of Representatives,
Subcommittee on Investigations and Oversight,
Committee on Science, Space, and Technology,
Washington, DC.
The Subcommittee met, pursuant to call, at 10:04 a.m., in
Room 2318 of the Rayburn House Office Building, Hon. Paul C.
Broun [Chairman of the Subcommittee] presiding.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
hearing charter
COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
U.S. HOUSE OF REPRESENTATIVES
SUBCOMMITTEE ON INVESTIGATIONS & OVERSIGHT
EPA's IRIS Program: Evaluating the Science
and Process Behind Chemical Risk Assessment
thursday, july 14, 2011
10:00 a.m. to 12:00 p.m.
2318 rayburn house office building
Purpose
On July 14, 2011, the Subcommittee on Investigations and Oversight
will hold a hearing on the U.S. Environmental Protection Agency's (EPA)
Integrated Risk Information System (IRIS). There will be two panels at
the hearing; the first panel will comprise of witnesses from EPA, the
U.S. Government Accountability Office (GAO), and the National
Academies' National Research Council. The second panel will include
individuals and experts who will talk about their perspectives on IRIS.
In March of 2008, GAO reported that ``the IRIS database was at
serious risk of becoming obsolete because EPA had not been able to
routinely complete timely, credible assessments. After subsequent
reports, in January 2009 [GAO] added EPA's processes for assessing and
controlling toxic chemicals to [its] list of areas at high risk for
waste, fraud, abuse, and mismanagement or in need of broad-based
transformation.'' \1\
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\1\ David Trimble, Director, Natural Resources and Environment,
Testimony before the Subcommittee on Investigations and Oversight,
Committee on Science, Space, and Technology, July 14, 2011
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As a result, the Subcommittee held several hearings on this
subject. On May 21, 2008, the Subcommittee took testimony from Dr.
George Gray, the then-Assistant Administrator for Research and
Development at EPA, and Ms. Susan Dudley, the then-Administrator of the
Office of Information and Regulatory Affairs (OIRA). Additionally, Mr.
John Stephenson of GAO testified on findings regarding the lack of
productivity in the IRIS process.
On June 12, 2008, the Subcommittee received testimony from Mr.
Jerry Ensminger (U.S.M.C., retired), Mr. Lenny Seigel (Executive
Director, Center for Public Environmental Oversight), and Dr. Linda
Greer (Director of the Health Program at the Natural Resources Defense
Council).
In 2009, the Subcommittee heard from Mr. John Stephenson again, and
Dr. Kevin Teichman, the Deputy Assistant Administrator for Science at
EPA's Office of Research and Development. They testified about the
current IRIS process announced by EPA Administrator Lisa Jackson on May
21, 2009.
These prior IRIS hearings focused on the IRIS interagency review
process, and delved into the role of the White House and other
agencies, to determine the extent of their involvement in IRIS'
chemical risk assessments. Today's hearing, prompted in part by the
National Academies' National Research Council report on EPA's
formaldehyde assessment, focuses on the process EPA uses to initially
develop draft IRIS assessments, which is separate from the overall
process that includes the multiple layers of review. The National
Academy of Sciences' (NAS) report dedicated an entire chapter that
reiterated several previous criticisms of EPA's IRIS process. In light
of those criticisms, and recognizing that this is not the first time
NAS has articulated them, the committee's goal is to better understand
the process behind the development of IRIS' chemical risk assessments,
whether EPA plans on adopting the NAS' recommendations, and whether or
not EPA assessments are based on the best available evidence and
evaluated in accordance with established protocols.
Background
IRIS was established in the 1980s as an internal EPA database to
provide a single source of information on the risks associated with
exposure to chemicals. The IRIS database provides a hazard
identification and dose-response analysis, scientific information that
when combined with estimates of exposure allow regulatory agencies to
produce a risk assessment. Historically, entries to the database were
the result of extensive in-house development by the science staff at
EPA, peer review processes with experts from outside the agency, and
opportunities for public input and comment.
By the early 1990s, the chemical database contained information on
roughly 500 chemicals. However, as IRIS grew and gained more influence,
EPA decided to restructure the IRIS process, which unfortunately led to
the demise of the heretofore successful collaborative platform. This
restructuring ultimately led to several reorganizations of the IRIS
process (see Appendix B), with the most recent one announced by EPA
Administrator Lisa Jackson on May 21, 2009.
In 2009, GAO testified before this Subcommittee that EPA ``has not
been able to complete timely, credible chemical assessments or decrease
its backlog of 70 [as of 2008] ongoing assessments.'' \2\ Further, GAO
reported, ``because EPA staff time was dedicated to completing
assessments in the backlog, EPA's ability to both keep the more than
540 existing assessments up to date and initiate new assessments was
limited. We found that 48 of the 70 assessments being conducted as of
December 2007 had been in process for more than 5 years-and 12 of
those, for more than nine years. These time frames have lengthened.
Currently, of those 70 assessments, 58 have now been ongoing for more
than 5 years-and 31 of those for more than 9 years.'' \3\
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\2\ John B. Stephenson, Director, Natural Resources and
Environment, Testimony before the Subcommittee on Investigations and
Oversight, Committee on Science and Technology, June 11, 2009
\3\ Ibid.
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The IRIS database currently includes 554 chemicals. Since GAO last
reported, EPA completed six assessments in 2009 and ten assessments in
2010. These numbers are far below the twenty assessments EPA planned to
finalize in 2010. \4\ Moreover, 70 chemicals continue to remain in
various stages of review.
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\4\ ``Update on Integrated Risk Information System (IRIS) Program
Activities,'' EPA, Office of Research and Development, National Center
for Environmental Assessment (NCEA) (hereinafter NCEA IRIS document)
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Further compounding the problem, EPA line offices are no longer
required to concur with IRIS assessments and internal EPA comments are
still not transparent. The quality of assessments being produced also
continues to be an issue. Since 2005, five assessments have been
referred to the National Academies' for evaluation. All of the NAS
reviews have severely criticized EPA's assessments, and offered
numerous recommendations, which EPA has yet to implement.
Issues
NAS: ``Review of the Environmental Protection Agency's Draft IRIS
Assessment of Formaldehyde''
On April 8 of this year, NAS published its long-awaited study on
EPA's formaldehyde assessment. While NAS ``strongly questioned EPA
claims that exposure to formaldehyde can result in increased risk of a
leukemia and other cancers that had not previously been associated with
formaldehyde, asthma, and reproductive toxicity,'' \5\ that is not the
most compelling part of the document for the purposes of this hearing.
Of interest is that the NAS panel ``strongly faulted EPA's methodology
in crafting its draft assessment, warning of a pattern of problems in
how the agency crafts assessments for its Integrated Risk Information
System (IRIS) database that could continue to hamper future risk
studies. `The committee is concerned about the persistence of problems
encountered with IRIS assessments over the years, especially given the
multiple groups that have highlighted them . . . If the methodologic
issues are not addressed, future assessments may still have the same
general and avoidable problems that are highlighted here.'' \6\
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\5\ Maria Hegstad, ``NAS Sets Back EPA Proposal For Strict
Formaldehyde Risk Assessment,'' Environmental NewsStand, April 8, 2011
\6\ Ibid.
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In the summary of the report, the panel commented on the
similarities in some of the problems with the IRIS assessment on
formaldehyde, and those identified in other reports published by
previous NAS panels:
``Overall, the committee noted some recurring methodologic problems
in the draft IRIS assessment of formaldehyde. Many of the problems are
similar to those which have been reported over the last decade by other
NRC committees tasked with reviewing EPA's IRIS assessments for other
chemicals. Problems with clarity and transparency of the methods appear
to be a repeating theme over the years, even though the documents
appear to have grown considerably in length. In the roughly 1,000-page
draft reviewed by the present committee, little beyond a brief
introductory chapter could be found on the methods for conducting the
assessment. Numerous EPA guidelines are cited, but their role in the
preparation of the assessment is not clear. In general, the committee
found that 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 estimates.'' \7\
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\7\ ``Review of the Environmental Protection Agency`s Draft IRIS
Assessment of Formaldehyde,'' National Research Council of the National
Academies, April 8, 2011 (hereinafter NAS Formaldehyde Report)
Please see Appendix A for detailed recommendations from the NAS
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report.
NAS: ``Science and Decisions: Advancing Risk Assessment'' \8\
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\8\ ``Science and Decisions: Advancing Risk Assessment,'' National
Research Council of the National Academies, 2009
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Dr. Thomas Burke, associate dean of The Johns Hopkins Bloomberg
School of Public Health, recently chaired an NAS panel on ``ways to
improve EPA risk assessments.'' \9\ At a joint meeting of EPA's Science
Advisory Board and EPA's Board of Scientific Counselors, Dr. Burke
said, ``The sleeping giant is that EPA science is on the rocks . . . if
you fail, you become irrelevant, and that is kind of a crisis.'' \10\
Referring to EPA's risk assessment process as the agency's ``Achilles
heel,'' \11\ Dr. Burke's NAS panel suggested steps on how EPA could
improve that process in a 2009 report titled, ``Science and Decisions:
Advancing Risk Assessment.'' This report carries added weight in light
of the NAS report on formaldehyde issued earlier this year with its
chapter critical of EPA's IRIS process.
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\9\ ``Key Advisor Warns EPA to Improve Agency Science or Face a --
Crisis,'' InsideEPA.com, July 8, 2011
\10\ Ibid.
\11\ Ibid.
NTP's RoC
The Department of Health and Human Services' (HHS) National
Toxicology Program (NTP) publishes a report every Congress called the
Report on Carcinogens (RoC). \12\ On June 10 of this year, the Twelfth
RoC was released, and it elevated its classification of formaldehyde
from `reasonably anticipated to be a human carcinogen' to `known to be
a human carcinogen.' The report was published despite the NAS review.
This is important because according to an analytic paper, NTP has:
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\12\ Maria Hegstad, ``NAS Critique of EPA Formaldehyde Study
Hampers HHS --Cancer` Report,'' Environmental NewsStand, April 26,
2011. ``Congress directed the program to prepare the report every other
year, but due to concerns over the review process for the document, the
last RoC was published in 2005. The RoC provides information on
chemicals that NTP deems carcinogenic or reasonably anticipates to be
human carcinogens, along with people's potential for exposure to
them.''
``been reviewing the scientific data for formaldehyde in preparation
for a listing decision in the 12th Report on Carcinogens (RoC). EPA and
the NTP have had available, reviewed and relied upon the same studies,
reports and underlying data in conducting their respective hazard
evaluations of the possible relationship between formaldehyde exposure
and leukemia and other lymphohematopoietic malignancies. Therefore, the
NRC committee's review of and conclusions concerning the draft EPA IRIS
report are, with respect to lymphohematopoietic malignancies (including
myeloid leukemia), directly applicable to the NTP's own review and
conclusions--precisely because the draft EPA and NTP reports involve
the same studies and data sets.'' \13\
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\13\ ``National Research Council Report on Scientific Evidence
Pertaining to the Relationship Between Formaldehyde Exposure and
Leukemia: Implications for the National Toxicology Program's Listing of
Formaldehyde in the 12th Report on Carcinogens,'' Environ International
Corporation, April 22, 2011 (emphasis in original text)
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Further:
``The NRC committee's opinion was that EPA's review of the scientific
literature as presented in the draft IRIS assessment does not provide a
sufficient scientific basis for concluding that there is a causal link
between formaldehyde exposure and leukemia. The NRC committee's
conclusions concerning EPA's assessment of leukemia apply as well to
application of the `listing criteria' for formaldehyde in the NTP's
12th RoC. In particular, there is no reasonable basis for the NTP to
conclude that formaldehyde should be listed in the 12th RoC as being
either `known' or `reasonably anticipated' to cause myeloid leukemia or
any other lymphohematopoietic malignancy.'' \14\
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\14\ Ibid. (emphasis in original text)
The RoC's more serious listing of formaldehyde could possibly
influence EPA's own assessment relating to formaldehyde and leukemia,
despite NAS' comments. Conversely, if EPA reassesses its formaldehyde
review and comes to a different conclusion, then that raises questions
about conflicting information from two different government entities,
which may cause confusion downstream as risk managers and regulators
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try to understand which determination is more reliable.
EPA's SAB
Under the current process, EPA's Science Advisory Board (SAB) is
responsible for peer reviewing EPA's IRIS assessments. However, ``there
have been questions in the past, including some raised by [EPA's]
Inspector General about the independence of the SAB panels.'' \15\
(Second footnote from passage) \16\The charge questions that lead SAB
peer reviews are ``written by the EPA office requesting the review and
which industry says can narrow the focus of the reviews. Sources also
say the panels do not include a broad-enough roster of experts. For
example, the SAB panel that recently reviewed EPA's IRIS assessment for
inorganic arsenic* * *did not include a statistician or a cancer
modeling expert and only one epidemiologist.'' \17\
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\15\ Aaron Lovell, ``Rebuffed by EPA, Industry Asks OMB, GOP to Fix
Chemical Study Process,'' Environmental NewsStand.com, June 22, 2011
(hereinafter Lovell Article)
\16\ U.S. EPA Office of Inspector General, ``EPA can Improve its
Process for Establishing Peer Review Panels,'' Evaluation Report No.
09-P-0147, April 29, 2009
\17\ Lovell Article, supra, note 11
IRIS Assessments are not Insulated from Risk Management
In the NAS' 1983 report, ``Risk Assessment in the Federal
Government: Managing the Process,'' the National Research Council panel
identified four components of a complete risk assessment:
hazard identification;
dose-response evaluation;
exposure assessment; and
risk characterization. \18\
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\18\ National Research Council, National Academy of Sciences,
``Risk Assessment in the Federal Government: Managing the Process,''
1983
IRIS reflects science that addresses the first two conditions. In
discussing the difference between risk assessment and risk management,
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the Academy panel wrote:
``Risk assessment is the use of the factual base to define the health
effects of exposure of individuals or populations to hazardous
materials and situations. Risk management is the process of weighing
policy alternatives and selecting the most appropriate regulatory
action, integrating the results of risk assessment with engineering
data and with social, economic and political concerns to reach a
decision.'' \19\
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\19\ Ibid.
This distinction is commonly cited when IRIS assessments are
criticized. When assessments make determinations that safe levels are
below background levels, the IRIS program can reasonably claim that
such factors can be weighed later in the risk management process. In
reality, IRIS assessments are usually adopted with no further
consideration. ``[S]ome customers use IRIS because it is a useful
source of information; while for other customers IRIS is mandatory, and
those customers include state agencies. Customers who use IRIS for
general information often rely upon other databases to complement an
IRIS assessment. Other databases exist, which can provide some help,
but for domestic regulatory purposes there is no satisfactory
alternative to IRIS. And using an IRIS file as the scientific basis for
a regulatory decision is expected and seldom challenged.'' \20\
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\20\ Jim Solyst, 11Eyeballing IRIS,'' The Environmental Forum,
March/April 2009, Vol 26, No. 2
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Witnesses
Panel 1
The Honorable Paul Anastas, Assistant Administrator,
Office of Research and Development, U.S. Environmental Protection
Agency. Dr. Anastas will talk about EPA's efforts to implement the most
recent revised IRIS process, provide a status of assessments, and
discuss EPA's efforts to implement NAS' and GAO's recommendations.
Mr. David Trimble, Director, Natural Resources and
Environment, U.S. Government Accountability Office. Mr. Trimble will
provide an overview of IRIS, highlight previous GAO work on IRIS, and
evaluate EPA's efforts to implement GAO's recommendations.
Dr. Jonathan M. Samet, MD, MS, Professor and Flora L.
Thornton Chair, Department of Preventive Medicine, Keck School of
Medicine, University of Southern California; and Chair, Committee to
Review EPA's Draft IRIS Assessment of Formaldehyde, National Research
Council, The National Academies. Dr. Samet will highlight the NAS'
recent work on IRIS, and detail NAS' recommendations contained in
chapter seven of their recently release report on formaldehyde.
Panel 2
The Honorable Calvin Dooley, President and Chief
Executive Officer, American Chemistry Council. Mr. Dooley will talk
about IRIS and industry's perspective on the IRIS process.
Ms. Rena Steinzor, Professor, University of Maryland
School of Law, and President, Center for Progressive Reform. Ms.
Steinzor will talk about IRIS, and offer suggestions on how to improve
it and remove it from GAO's high risk series.
Dr. Gail Charnley, Principal, HealthRisk Strategies. Dr.
Charnley will talk about IRIS, offer suggestions on how to improve it
and remove it from GAO's high risk series, and discuss the NAS'
recommendations.
The Honorable J. Christian Bollwage, Mayor, City of
Elizabeth, New Jersey. Mayor Bollwage will talk about how IRIS
assessments impact local communities, particularly Elizabeth, New
Jersey.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Chairman Broun. The Subcommittee on Investigations and
Oversight will come to order. Good morning, everyone. Welcome
to today's hearing titled EPA's IRIS Program: Evaluating the
Science and Process Behind Chemical Risk Assessment. You will
find in front of you packets containing our witnesses'--our
witness panels' written testimony, biographies, and truth in
testimony disclosure.
I recognize myself for five minutes for an opening
statement.
Good morning. I want to welcome our witnesses here today.
This hearing continues the committee's work on EPA's
Integrated Risk Information System or IRIS. The committee has
held a number of hearings over the last few years on IRIS's
ability to produce risk assessments associated with exposure to
chemicals. In 2009, GAO placed the program on its High Risk
Series because EPA was unable to complete timely, credible
chemical assessments or decrease its backlog of ongoing
assessments.
Over the last decade, the IRIS Program has gone through a
number of changes, particularly to the process by which its
assessments are reviewed. These changes were meant to address
the inappropriate influence of the White House, regulated
agencies, and industry on the IRIS process; the argument being
that these entities were preventing assessments from being
finalized. Despite these changes, the process implemented by
EPA in 2009 still allows for White House input, and the program
still has a backlog of over 70 assessments, unchanged from the
previous Administration.
While EPA seems to be taking steps to adopt the
recommendations of GAO regarding outside review, they have
uniformly ignored the recommendations of another body, the
National Academy of Sciences. For several years now they, too,
have offered recommendations related to IRIS. These
recommendations, however, did not focus on the review process
but rather on how EPA develops the draft assessments in the
first place. Time and time again, draft assessments were sent
to the NAS for review, only to be severely criticized. Rather
than adopting the recommendations of the Academy and updating
their processes, EPA continued to churn out assessments that
were summarily rebuked.
As I stated at our 2009 hearing, ``The competing priorities
of issuing assessments in a timely manner and producing
assessments that are scientifically credible are central to the
problems we face today.'' That statement remains just as true
today as it did two years ago. Up until now, EPA has blamed
outside forces for the failures of the program. In reality,
they, too, are to blame. The program's credibility is
threatened when it continually puts forth assessments that fail
to address fundamental issues raised by reviewers. If, as the
old adage goes, the definition of insanity is doing the same
thing over and over and expecting a different result, then this
program needs some therapy.
Adopting the NAS recommendations is the first step to
restoring the program's credibility. EPA's announcement 2 days
ago is a step in the right direction, but the program's success
hinges on its implementation. As the Academy noted in its
formaldehyde report, many of the concepts and approaches they
recommended are elementary and already exist in EPA's
guidelines. They went on to state, ``The current state of the
formaldehyde draft IRIS assessment suggests that there might be
a problem with the practical implementation of the guidelines
in completing the IRIS assessments.''
Following through is the key here. It is up to the EPA to
not only adopt the NAS recommendations but to also follow its
own existing guidelines. This committee will continue its
oversight of the IRIS program to ensure that EPA not only
adopts the NAS recommendations, but that it follows guidelines
already in existence and continuously seeks to employ the most
modern, credible methods and protocols to assess chemical
risks.
I have a lot of questions about this program and where it
is headed. As GAO stated in their testimony in 2009, ``EPA
needs to hold itself more accountable to the public and
Congress for carrying out this important component of its
mission, especially since the IRIS program is discretionary.''
As a physician myself, I understand the stakes that we are
dealing with, particularly for sensitive populations such as
children, pregnant women, and the elderly. I want to make sure
that they are protected from undue harm. I also am aware of the
damage caused by overly-conservative measures that scare our
citizens without reason, ultimately doing nothing to advance
safety. The opening line of the NAS's report titled, ``Science
and Decisions,'' stated, ``Virtually every aspect of life
involves risk.'' It is how we assess and manage that risk that
ensures our safety.
[The prepared statement of Mr. Broun follows:]
Prepared Statement of Chairman Paul Broun
Good morning. I want to welcome our witnesses here today.
This hearing continues the committee's work on the EPA's Integrated
Risk Information System, or ``IRIS.'' The Committee has held a number
of hearings over the last few years on IRIS's ability to produce risk
assessments associated with exposure to chemicals. In 2009, GAO placed
the program on its High Risk Series because EPA was unable to complete
timely, credible chemical assessments or decrease its backlog of
ongoing assessments.
Over the last decade, the IRIS program has gone through a number of
changes--particularly to the process by which its assessments are
reviewed. These changes were meant to address the inappropriate
influence of the White House, regulated agencies, and industry on the
IRIS process-- the argument being that these entities were preventing
assessments from being finalized. Despite these changes, the process
implemented by EPA in 2009 still allows for White House input, and the
program still has a backlog of over 70 assessments--unchanged from the
previous administration.
While EPA seems to be taking steps to adopt the recommendations of
GAO regarding outside review, they have uniformly ignored the
recommendations of another body - the National Academy of Sciences. For
several years now, they too have offered recommendations related to
IRIS. These recommendations, however, did not focus on the review
process, but rather on how EPA develops the draft assessments in the
first place. Time-and-time-again, draft assessments were sent to the
NAS for review, only to be severely criticized. Rather than adopting
the recommendations of the Academy, and updating their processes, EPA
continued to churn out assessments that were summarily rebuked.
As I stated at our 2009 hearing, ``[t]he competing priorities of
issuing assessments in a timely manner and producing assessments that
are scientifically credible are central to the problems we face
today.'' That statement remains just as true today as it did two years
ago. Up until now, EPA has blamed outside forces for the failures of
the program. In reality, they too are to blame. The program's
credibility is threatened when it continually puts forth assessments
that fail to address fundamental issues raised by reviewers. If, as the
old adage goes, the definition of insanity is doing the same thing over
and over and expecting a different result, then this program needs some
therapy.
Adopting the NAS recommendations is the first step to restoring the
program's credibility. EPA's announcement two days ago is a step in the
right direction, but the program's success hinges on its
implementation. As the Academy noted in its formaldehyde report, many
of the concepts and approaches they recommended are elementary and
already exist in EPA's guidelines. They went on to state ``the current
state of the formaldehyde draft IRIS assessment suggests that there
might be a problem with the practical implementation of the guidelines
in completing the IRIS assessments.''
Following through is the key here. It is up to the EPA to not only
adopt the NAS recommendations, but to also follow its own existing
guidelines. This Committee will continue its oversight of the IRIS
program to ensure that EPA not only adopts the NAS recommendations, but
that it follows guidelines already in existence, and continuously seeks
to employ the most modern, credible methods and protocols to assess
chemical risks.
I have a lot of questions about this program and where it is
headed. As GAO stated in their testimony in 2009, ``EPA needs to hold
itself more accountable to the public and Congress for carrying out
this important component of its mission, especially since the IRIS
program is discretionary.''
As a physician myself, I understand the stakes we are dealing
with--particularly for sensitive populations such as children, pregnant
women, and the elderly. I want to make sure they are protected from
undue harm. I also am aware of the damage caused by overly conservative
measures that scare our citizens without reason, ultimately doing
nothing to advance safety. The opening line of the NAS's report titled
Science and Decisions stated, ``[v]irtually every aspect of life
involves risk.'' It is how we assess and manage that risk that ensures
our safety.
I now recognize the Ranking Member from Maryland for her opening
statement.
Chairman Broun. Now I recognize the Ranking Member from
Maryland for her opening statement. I recognize Ms. Edwards for
five minutes.
Ms. Edwards. Good morning, and thank you, Mr. Chairman.
For 50 years the tobacco industry has waged an organized
campaign to cast doubt on the health risks of smoking
cigarettes. They invented the effort to use science to fight
science, to harness industry-funded research and public
relations efforts, and to use friendly, public officials and
FORA to point to these manufactured uncertainties in opposing
any effort to protect the public.
During that entire time public health experts have known
absolutely that smoking causes cancer and that smoking remains
in the words of the surgeon general, ``the single most
important preventable cause of death in our society.'' This
model of industry-funded science is being used to generate
uncertainty and postpone even minor regulatory steps,
regardless of the effects on public health and repeated with
gusto by other industries.
A similar campaign is being waged by the fossil fuel
industry to cast doubt on the science of climate change, and
today we are going to see some of this unfolding, surrounding
EPA's science-based efforts to develop risk assessments related
to health consequences of chemicals that Americans are exposed
to commonly.
Industry tends to push for two things in the realm of
science and regulation. First they demand that we must have
certainty before any action can be taken, and second, they
point to studies that suggest there is uncertainty. What they
don't mention quite so prominently is that the industry funds
the production of studies designed to so doubt. That
manufactured doubt is then used to justify inaction because
obviously, there is no certainty. The result is gridlock. The
country ends up in an endless loop of science, research,
science, research that is expensive and counterproductive and
making it almost impossible to ever make a statement about the
harm of anything.
With enough money and enough willing researchers, there is
always money and there are always willing payees. Industry can
be certain that there is always another study just around the
corner, no matter the chemical or the consensus regarding its
harm with the industry, generally hoping that the study will
show no harm.
In this world the scientists being paid say 325 bucks an
hour, by the way, who work for industry, are not working to
understand a problem but to provide answers that their clients
want to use for their public relations campaigns. In 1983, the
National Academy of Science has issued a red book on risk
assessment. For almost 3 decades that has been the Bible on how
to conduct a risk assessment. The report was motivated in part
by a desire to try to set the science of assessing risk outside
the political environment that surrounded decisions about what
to do about those risks.
But deep pockets readily use the report to see science as a
fertile ground for fighting regulation. Industry learned that
they can forestall any movement out of the realm of risk
assessment and into the realm of risk management by
manufacturing doubt, a process institutionalized by the NAS
book. Not by NAS but by those who used it.
Now the Academy has marched again into a situation that
they may not have fully anticipated. The NAS report on EPA's
draft formaldehyde assessment contains a very useful roadmap
for how EPA should undertake reorganizing their IRIS
assessments to make them more comprehensible and transparent,
and though Dr. Anastas has embraced those recommendations,
embraced the recommendations, the industries that most worry
about IRIS assessments has seized on the language of the NAS
report to try to claim that EPA cannot be trusted to do the
science. That is not the message of the NAS report not the
intention of the Academy panel.
Under the Bush Administration that so crippled the EPA
through a broken program with interference by OMB, that agency
was able to finalize only a couple of IRIS assessments a year.
EPA Administrator Lisa Jackson put in place a new process that
severely cut back on OMB and polluting agency interference.
So today we are going to hear from industry prescribers
that go back to this kind of OMB-dominated system in which
there is a suggestion that no assessment can ever be finalized
without the Academy peer review of the draft assessment and
then another peer review of the redrafted assessment.
Instead I suggest that we follow the National Academy's
advice. All the EPA the time to institute the kind of changes
proposed in the formaldehyde review. Dr. Anastas has already
proposed an initiative tied to the Academy roadmap that appears
to be responsive and robust. It seems clear to me that to allow
EPA to do their job with the advice from the Academy and not
get captured by the endless science of the doubt machine is the
direction that we should go.
I look forward to hearing from our witnesses today to cast
light on this process and to ensure that we have agencies that
are actually working in the public interest and not in the
private interest.
Thank you, and I yield.
[The prepared statement of Ms. Edwards follows:]
Prepared Statement of Ranking Member Donna F. Edwards
For fifty years the tobacco industry has fought a campaign to cast
doubt on the health risks of smoking cigarettes. They invented the
effort to use ``science'' to fight science; to harness industry-funded
research for public relations campaigns; and to use friendly public
officials to point to these manufactured uncertainties in opposing any
effort to protect the public.
And during that entire time, public health experts have absolutely
known that smoking causes cancer, and that smoking remains--in the
words of the Surgeon General--``the single most important preventable
cause of death in our society.''
That model of industry-funded science being used to generate
uncertainty and postpone even minor regulatory steps--regardless of the
effects on public health--has been taken up with gusto by other
industries. A similar campaign is being waged by the fossil fuel
industry to cast doubt on the science of climate change. And today we
are going to see some of this unfold surrounding EPA's science-based
efforts to develop risk assessments of the health consequences of
chemicals to which Americans are commonly exposed.
Industry tends to push for two things in the realm of science and
regulation: first they demand that we must have certainty before any
action can be taken, and, second, they point to studies that suggest
there is uncertainty. What they don't mention quite so prominently is
that they fund the production of studies designed to create doubt. That
manufactured doubt is then used to justify inaction because, obviously,
there is no certainty.
The country ends up in an endless science loop that makes it almost
impossible to ever make a statement about the harm of anything. If an
agency tries to take a position, industry argues that there is
``another study'' just around the bend for which the agency should
wait. With enough money and willing researchers, industry can guarantee
that there is always another study just around the corner no matter the
evidence regarding its harm.
Of course the science that industry funds is specifically aimed at
producing studies that show no harm from their products. In this world,
the scientists who work for industry are not working to honestly
understand a problem, but to provide answers that their clients want to
use for their public relations campaigns. And make no mistake, no one
pays you $325 an hour to produce science that isn't useful to their
interests.
The National Academy of Sciences has not been blind to this
development in America's science and regulatory landscape. In 1983, the
National Academy of Sciences issued the ``red book'' on Risk
Assessment. For almost three decades that has been the bible on how to
conduct a risk assessment. The report was motivated, in part, by a
desire to try to set the science of assessing risks outside the
political environment that surrounded decisions about what to do about
those risks--a process they labeled risk management. The Academy,
perhaps naively, hoped that all the struggles over regulatory decisions
would be focused on risk management.
What the Academy did not anticipate was how readily those with deep
pockets would see science as fertile ground for fighting regulation.
Industry learned that they can stall any movement out of the realm of
risk assessment by manufacturing doubt, and the NAS red book helped
institutionalize this system.
And now the Academy has again marched into a situation that they
may not have fully anticipated. The NAS report on EPA's draft
formaldehyde assessment contains a very useful ``roadmap'' for how EPA
should undertake reorganizing their IRIS assessments to make them more
comprehensible and transparent. To his credit, Dr. Anastas has embraced
those recommendations. But the industries that most worry about IRIS
assessments have seized on the language of the NAS report to try to
claim that EPA cannot be trusted to do science.
That is not the message of the NAS report nor the intention of the
Academy panel.
If the Academy panel thought EPA could not institute
effective changes, they would not have suggested EPA undertake them.
If the NAS panel did not think IRIS assessments were
needed or could be produced to a high quality, they would not have
advised EPA to continue to put out those assessments even as they work
to incorporate changes to that process as recommended by the Academy.
If the panel did not trust EPA's ability to make
appropriate changes to the draft-formaldehyde assessment, they could
have recommended that EPA return to the Academy for a second review of
that assessment. They did not make such a recommendation.
Yet we will have testimony today from an industry-funded scientist
that goes so far as to say that in light of the Academy study, the IRIS
program should be killed.
The IRIS program was a broken program during the Bush
Administration. By 2006-2007, interference by OMB and endless science
challenges by industry and polluting agencies that did not want to
clean-up their messes--such as those documented at Camp LeJeune--had so
crippled EPA that they were able to finalize only a couple of IRIS
assessments a year.
Pressure from this Subcommittee helped inspire GAO to put IRIS on
their high risk watch list and inspired the new Administrator of EPA,
Lisa Jackson, to put in place a new process that severely cut back on
the opportunities for OMB and polluting agencies to interfere with
EPA's production of IRIS assessments.
It is too soon to know whether these steps will bear fruit, but we
do know this: every IRIS assessment that the Academy has reviewed in
the last half-dozen years, including the formaldehyde assessment, was
largely a result of that broken process whereby OMB dictated to EPA
much of the content and organization of those assessments. I would
suggest that if the reports lacked coherence or clear communications
perhaps it is because they were heavily interfered with by these non-
EPA parties who insisted on new chapters, new sections, new issues and
new articles being added.
And the cure that industry prescribes for improving IRIS reports?
Why, go back to the OMB-dominated system that produced them in the
first place! Mr. Dooley sent a letter making just such a suggestion to
Jack Lew. They further advocate that no assessment ever be finalized
without an Academy peer review of the draft assessment and then another
peer review of the redrafted assessment.
Could the intent to slow roll action be any more transparent? And
in the years between Academy reviews, just imagine how many new
industry-funded studies might be created to throw up ever more science
chaff in the path of EPA? These are not cures that will heal the IRIS
program, but are designed to bleed it to death.
Instead, I suggest that we follow the National Academy's advice.
Allow EPA the time to institute the kinds of changes proposed in the
formaldehyde review. Dr. Anastas has already proposed an initiative
tied to the Academy roadmap that appears responsive and robust. And
there is a new director of the IRIS program, Dr. Cogliano, who has been
recruited to do for IRIS what he did for the International Agency for
Research on Cancer risk process.
We have good people in place and good advice from the Academy. Let
us allow them to do their job and not get captured by the endless
science doubt machine.
Chairman Broun. Thank you, Ms. Edwards. If there are
Members who wish to submit additional opening statements, your
statements will be added to the record at this point.
Now, before we begin, let me note that, again, testimony
from the EPA was not received within the timeframe established
in our committee rules. Testimony was not received until 2:47
p.m. yesterday, with additional supplements trickling in at
5:45 p.m. yesterday.
Committee rule 7(B)(1) states that, ``Insofar as is
practicable, no later than 48 hours in advance of his or her
appearance each witness who is to appear before the committee
shall file in printed copy and in electronic form a written
statement of his or her proposed testimony and the curriculum
vitae. Late testimony inhibits the committee's ability to fully
evaluate the matter before it. Late delivery of testimony could
set the stage for the committee to refuse to accept the written
testimony of or hear from a witness.''
In this instance it is imperative that EPA testify, but EPA
has once again obstructed the committee's ability to conduct
legitimate oversight. EPA provided late testimony to the fiscal
year 2012 budget hearing on March 10, late testimony to the May
11 hearing on hydraulic fracturing, and late testimony for the
E-15 hearing on July the 7th .
Additionally, questions for the record from the fiscal year
2012 budget hearing were due on March 24, yet the committee
only received responses 2 days ago, almost 4 months late.
This is intolerable. The committee provided EPA a heads up
on this hearing almost 2 months ago, providing ample time for
OMB to review EPA's testimony. Dr. Anastas, this is
unacceptable, and I expect EPA's testimony to be on time so
that this committee can execute its responsibilities, and I
hope in the future that we can count on you to do so and other
officials with EPA to do so, and I would appreciate a very
prompt response to our request.
At this time I would like to introduce our first panel of
witnesses. Dr. Paul Anastas, Assistant Administrator for the
Office of Research and Development at the U.S. Environmental
Protection Agency. Mr. David Trimble is the Director of Natural
Resources and Environment at the U.S. Government Accountability
Office. Dr. Jonathan Samet, is that correct? Samet. Okay.
Samet, MD, served as Chair of the National Research Council's
committee to review EPA's draft IRIS assessment of
formaldehyde. Dr. Samet also previously chaired the National
Research Council's Board on Environmental Studies and
Toxicology, where he evaluated the EPA's reassessment of dioxin
and related compounds.
As our witnesses should know, spoken testimony is limited
to five minutes each, after which the Members of the committee
will have five minutes each to ask questions. Your written
testimony will be included in the record of the hearing. It is
the practice of the Subcommittee on Investigations and
Oversight to receive testimony under oath. Do any of you have
any objection to taking an oath?
Let the record reflect that all witnesses are willing to
take an oath. They indicated that by shaking their head from
side to side, even though we heard no rattles. I saw it.
You all may also be represented by counsel. Do any of y'all
have counsel here today? Y'all is Southern for you all.
Let the record reflect that none of the witnesses have
counsel. They again indicated by the shake of their head,
indicating no. If all of you would please stand now and raise
your right hand, do you solemnly swear or affirm to tell whole
truth and nothing but the truth, so help you God?
Let the record reflect that all witnesses participating
have taken the oath. Please take your seat.
Now I recognize our first witness, Dr. Anastas.
TESTIMONY OF THE HONORABLE PAUL ANASTAS,
ASSISTANT ADMINISTRATOR, OFFICE OF RESEARCH
AND DEVELOPMENT, U.S. ENVIRONMENTAL PROTECTION AGENCY
Dr. Anastas. Good morning, Chairman Broun, Ranking Member
Edwards, and other Members of the committee. I am Paul Anastas.
I am the Assistant Administrator for the Office of Research and
Development at the U.S. Environmental Protection Agency and the
Agency's Science Advisor.
Before I begin let me make a personal statement to this
committee, and I think this committee appreciates the amount of
respect that I have for this committee, and I want to give a
personal apology to this for the tardiness of today's
testimony. I do believe it was prepared promptly, and my
apologies for the clearance process that may have delayed that.
So that is something that I think is important and that I take
seriously personally.
Chairman Broun. Accepted and I greatly appreciate that. We
look forward to having the testimony presented in a timely
manner in the future. Thank you, and I am going to expect that,
and I think you are a man of your word, and I appreciate that
assurance that we can have that. Thank you.
Dr. Anastas. Thank you, and thank you for the opportunity
to be with you here today to discuss the EPA Integrated Risk
Information System, otherwise known as IRIS. EPA plays a
critical role in providing high quality health information on
chemicals of concern. The agency's IRIS Assessment Program is a
key part of this effort. It includes human health assessments
on more than 540 chemical substances. These assessments provide
the sound scientific basis for EPA decisions and are widely
used by risk assessors, health professionals, state and local
governments, as well as international governments.
EPA is committed to upholding the highest standard of
scientific integrity in all of its activities. This means
constantly seeking to improve, strengthen, and enhance our
scientific work to reflect the best available information.
Continuous improvement of the IRIS Program is an important part
of this effort.
The EPA recently announced changes to the IRIS Program that
will ensure we continue to use the best and most transparent
science to pursue our mission of protecting human health and
the environment. The new changes build upon the significant
improvements initiated by Administrator Lisa Jackson in 2009.
For example, since 2009, EPA has completed 16 IRIS
assessments, more than the total number of assessments that
were completed in the previous four years. We have cut down the
average timeframe for completing assessments from between 3 and
four years to within two years, and reduced the backlog of
assessments in the pipeline, and yes, new assessments have been
added to that pipeline, so that may be why the number looks to
be the same.
These improvements have been accompanied by a strong and
continued emphasis on independent peer review of the IRIS
Program. In April of this year EPA received a report from the
National Academy of Sciences on their review of EPA's draft
IRIS assessment on formaldehyde. EPA welcomes and accepts the
recommendations of the NAS on the formaldehyde assessment and
will incorporate these recommendations in the revision of the
assessment.
In the report the NAS also suggested ways to improve the
IRIS process in two primary areas; accessibility and
transparency. Because EPA is constantly seeking feedback from
credible, independent scientific sources, we welcome these
suggestions and are incorporating them fully into the IRIS
Program.
The new IRIS assessment documents will be shorter, clearer,
more concise, and more transparent. IRIS users can expect to
see a reduced volume of text and increased clarity and
transparency of data, methods, and decision criteria. IRIS
documents will rigorously be edited to eliminate any
inconsistencies and redundancies and will include more
graphical and tabular representations of the data.
Related discussions will be consolidated into concise,
narrative descriptions, and references to all studies used in
the assessment development will be posted online. To make the
scientific rationale of IRIS assessments as transparent as
possible, the EPA will evaluate the strengths and weaknesses of
critical studies in a more uniform way. We will also clearly
indicate which criteria were most influential in weighing
scientific evidence, supporting its choice of toxicity values.
EPA is working closely with the Agency's Science Advisory Board
to focus its expertise on how to best respond to the NAS
suggestions.
In addition, we continue to be committed to full
consultation with scientists throughout the government and
carefully consider and respond to their input. We will add a
peer consultation step to the early stages of major IRIS
assessments to assure that the scientific community can provide
input as we make critical design decisions for individual
assessments.
These changes will be implemented over the coming months in
a tiered approach, with the most extensive changes applied to
those assessments in the earlier stages of development. These
improvements are part of the natural evolution that accompanies
all rigorous scientific work. We will continue to consider
information and perspectives from independent scientific
sources and pursue improvements in an ongoing basis.
Thank you. I will be happy to answer any questions at the
appropriate time as the chair directs.
[The prepared statement of Mr. Anastas follows:]
Prepared Statement of The Honorable Paul Anastas, Assistant
Administrator, Office of Research and Development, U.S. Environmental
Protection Agency
Good morning Chairman Broun, Ranking Member Edwards and other
Members of the Committee. My name is Paul Anastas. I am the Assistant
Administrator for Research and Development (ORD) at the Environmental
Protection Agency and the Agency's Science Advisor. It is a pleasure to
be here with you this morning to discuss EPA's Integrated Risk
Information System (IRIS).
Background and Description of IRIS Program
EPA recognizes the critical role we play in disseminating timely,
high-quality and accessible human health risk information on
environmental contaminants that may endanger the health of the American
public. Central to this aspect of EPA's mission is its Integrated Risk
Information System, commonly called the IRIS program, which provides
health effects information on chemicals to which the public may be
exposed from releases to air, water, and land and through the use and
disposal of products. IRIS assessments provide a scientific foundation
for EPA decisions to protect public health across EPA's programs and
regions under an array of environmental laws. While not regulations,
IRIS assessments are critical to many Agency decisions. IRIS is also a
resource for risk assessors and environmental and health professionals
in state and local governments and other countries. After becoming
Administrator in early 2009, Administrator Jackson reviewed the IRIS
program and asked the Office of Research and Development (ORD) in May
2009 to implement a new IRIS process that would revitalize the program
and make it more responsive to the needs of the Agency. The aim of the
new process was to ensure the highest level of scientific quality,
integrity, transparency, and timeliness.
EPA's Actions to Implement the 2009 IRIS Process
EPA undertook several actions to implement the new IRIS process in
2009. EPA regularly solicits public comments on the IRIS agenda, and
ORD works directly with program and regional offices to ensure that
IRIS assessments meet their needs. To ensure that IRIS assessments are
focused on the highest priority needs, EPA expanded the role of the
program and regional offices in nominating and prioritizing chemicals
for assessment.
EPA also has increased efforts to work with other agencies to share
data and avoid duplication of effort. For example, ORD has a new
Memoranda of Understanding with the California Environmental Protection
Agency's Office of Environmental Health Hazard Assessment in addition
to an existing Memoranda of Understanding with the Agency for Toxic
Substances and Disease Registry. These efforts help to increase
efficiency and assessment output. The Agency is also working closely
with its Science Advisory Board on how to bring to bear its expertise
on an ongoing basis to focus on the quality, transparency, and
scientific rigor of IRIS assessments and guide EPA's response to the
NAS recommendations. We will add a peer consultation step to the early
stages of major IRIS assessments to assure that the scientific
community can provide input as we make critical design decisions for
individual assessments. The Agency also created an IRIS logistics team
to coordinate all administrative support to improve efficiency and
place increased emphasis on the scientific quality of assessments by
allowing scientific staff to focus on the science. In addition, EPA
developed the Health and Environmental Research Online database,
referred to as HERO, which promotes transparency in risk assessments by
capturing the literature used in EPA's health and environmental
assessments and making the scientific studies used to develop
assessments available to the public. The HERO database is web-based and
accessible to everyone.
These actions, collectively, have led to improved results in the
IRIS process. Specifically, EPA has completed 16 assessments since
2009, more than the number of assessments that were completed in the
previous four years. EPA has reduced the IRIS backlog and is currently
working on over 70 assessments. In 2010, EPA released nine assessments,
seven of which were major assessments, for external peer review and
public comment. Overall the new 2009 process resulted in greater
involvement of EPA scientists and the public in the process.
In summary, there have been many improvements to the IRIS program
since 2009 to provide high quality assessments in a timely fashion.
Assessment development time was shortened to 23 months for most
assessments, which will speed the availability of IRIS assessments for
use by the risk assessment community and public. The IRIS program is
now entirely managed by EPA and EPA strives to ensure that all of its
science assessments undergo rigorous, open and independent external
peer review and that multiple opportunities exist for public review and
comment. Additionally, changes in IRIS assessments that occur during
the interagency and public process are documented and explained,
ensuring a transparent final product.
IRIS Process and the NAS Review
In April 2011, the NAS released its review report of EPA's draft
IRIS risk assessment of formaldehyde and included comments and
recommendations to improve the IRIS process. EPA welcomes those
recommendations and will be addressing all of them in a phased-in
fashion. We note that the NAS specifically focused their comments on
the development of draft IRIS assessments and did not recommend changes
to the steps that occur later in the process. Additionally, the NAS
recognized that EPA's implementation of their suggested changes would
require a multiyear process. A summary of the NAS overall
recommendations and EPA's responses to them are described below. \1\
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\1\ 1 Full text from p. 152 of the final published NAS report.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
1. NAS recommended that EPA rigorously edit documents to reduce
the text volume and address redundancies and inconsistencies.
To respond to this recommendation, EPA is rigorously editing our
assessment documents to substantially reduce the volume of text and
address redundancies and inconsistencies; building on the existing IRIS
guidelines and process to enhance the clarity and transparency of data
evaluation and the presentation of findings and conclusions;
consolidating related discussions to eliminate redundancies; increasing
the use of tables and figures to improve communication of information;
and providing reference information on the IRIS website for all studies
considered.
2. NAS recommended that EPA include a fuller discussion of methods
and develop concise statements of the criteria used to exclude, include
and advance studies for hazard evaluation and derivation of toxicity
values.
In response to this recommendation, EPA is providing a fuller
discussion of the methods used in our assessments, along with concise
statements of the criteria used to exclude, include, and focus on the
highest quality studies for hazard assessment and for derivation of
toxicity values.
3. NAS recommended standardized evidence tables for all health
outcomes.
EPA is working towards replacing text descriptions of the studies
with standardized evidence tables that provide the methods and results
of each study for all health outcomes; and including text that will
accompany evidence tables to present the criteria used to include or
exclude studies.
4. NAS recommended that EPA provide a clearer articulation of the
rationale and criteria for screening studies.
To accomplish this, EPA is enhancing our sequential approach for
progressively focusing on the most pertinent information, including:
searching the literature, identifying the pertinent studies, and
evaluating study characteristics; evaluating the overall weight of
evidence for each health outcome; identifying plausible approaches for
developing toxicity values; selecting the most pertinent data and
developing toxicity values for each health hazard; and portraying
toxicity information graphically.
5. NAS recommended that EPA use uniform approaches to thoroughly
evaluate the strengths and weaknesses of critical studies, summarize
findings in tables, and clearly articulate the rationale for the
studies used to calculate toxicity values.
To respond to these two suggestions EPA is streamlining IRIS
assessment documents and more fully document our approach for
assembling and evaluating the range of scientific data. As the NAS
report indicated, we have already made similar changes to how we
present the scientific evidence on the criteria air pollutants in our
Integrated Science Assessments, and we are confident we can make
comparable improvements in how we present our analysis of health study
findings for chemicals evaluated in the IRIS program. EPA is also
implementing a more uniform approach to our evaluation of the strengths
and weaknesses of critical studies to increase the clarity of the
rationale for selecting the studies used to calculate toxicity values.
Lastly, we are increasing the use of evidence tables that summarize the
factual details of pertinent studies for each health hazard and
developing standardized language to describe study strengths and
limitations.
6. NAS recommended that EPA provide descriptions to indicate
various determinants of weight of evidence to promote understanding of
what elements were emphasized in synthesizing the evidence.
In response, EPA is augmenting its current analysis of data to
indicate which criteria were most influential in evaluating the weight
of evidence.
Timeline for Responding to NAS Recommendations
EPA's overarching goal is to continually improve our IRIS
assessments, recognizing that these improvements will have a greater
impact on our new assessments as opposed to those already in the
pipeline. It is important to note that the NAS report viewed the
implementation of their recommendations as a multi-year process. For
example, the NAS stated `it is not recommending that EPA delay the
revision of the formaldehyde assessment to implement a new approach.''
To that end, EPA is doing the following:
Assessments that have already been peer-reviewed or
released for peer review: We are revising these assessments to address
peer review comments, especially those that call for increased
transparency of study selection and evidence evaluation.
Assessments currently under development but not yet
released for peer review: We are re-examining these assessments to
ensure that the rationale for study selection and evidence evaluation
is clear. These assessments will also be edited to reduce redundancy.
New assessments that have not yet been started: We will
fully implement the NAS recommendations for new assessments, including
a tighter document structure, evidence tables to summarize details from
pertinent studies, greater transparency in study selection and
evaluation criteria, and greater emphasis on clear analysis and
synthesis.
The standards to which IRIS assessments are held, including the
rigorous independent external peer review of every draft IRIS
assessment, are among the best in the federal government and the
scientific community. Over the coming months, the IRIS program will
fully implement the NAS recommendations and continue to improve the
IRIS process to reflect the highest standards of scientific integrity
and credibility. Strengthening and streamlining the IRIS process is a
continuing and ongoing priority for EPA. Thank you for the invitation
to share my thoughts on this important topic. I will gladly answer any
questions you have.
Chairman Broun. Thank you, Dr. Anastas.
I now recognize our next witness, Mr. Trimble.
TESTIMONY OF DAVID TRIMBLE,
DIRECTOR, NATURAL RESOURCES AND ENVIRONMENT,
U.S. GOVERNMENT ACCOUNTABILITY OFFICE
Mr. Trimble. Chairman Broun, Ranking Member Edwards, 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 540 chemicals in the
environment. IRIS assessments are a critical component of 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 timeframes 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 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 a 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 the other interested
federal agencies from the public record.
Concerned with these problems 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 increased attention
by executive agencies and Congress.
In May 2009, the EPA made significant changes to the IRIS
process. In June of that year we testified before this
Subcommittee 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 on draft IRIS assessments be part of
the public record, adding transparency and credibility to the
process. Third, the new process 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 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 complete
timely, credible IRIS assessments.
First, the 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 one delay can have a
domino affect, requiring the process to essentially be repeated
to incorporate changing science.
Second, EPA faces long-standing difficulties in completing
assessments of chemicals of key concerns; 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, attaining credible expert review and finalizing IRIS
assessments.
Third, EPA must be disciplined in keeping to timelines,
even in the absence of 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
imperative for EPA to maintain a stable 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 a report
later this year.
That concludes the summary of my statement. I will be happy
to answer any questions that you or the Members of the
committee may have.
[The prepared statement of Mr. Trimble follows:]
Prepared Statement of Mr. David Trimble, Director, Natural Resources
and Environment, U.S. Government Accountability Office
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Chairman Broun. Thank you, Mr. Trimble.
I know recognize for five minutes our next witness, Dr.
Samet.
TESTIMONY OF JONATHAN M. SAMET, MD, MS,
PROFESSOR AND FLORA L. THORNTON CHAIR,
DEPARTMENT OF PREVENTATIVE MEDICINE,
KECK SCHOOL OF MEDICINE, UNIVERSITY OF SOUTHERN
CALIFORNIA, AND CHAIR, COMMITTEE TO REVIEW
EPA'S DRAFT IRIS ASSESSMENT OF FORMALDEHYDE,
NATIONAL RESEARCH COUNCIL, THE NATIONAL ACADEMIES.
Dr. Samet. Good morning, Mr. Chairman and Members of the
Subcommittee. I am Jonathan Samet from the University of
Southern California. As noted, I chaired the National Research
Council committee that reviewed the EPA's draft IRIS
formaldehyde assessment. I also currently chair the Clean Air
Scientific Advisory Committee of the Agency.
The draft, our review of the draft assessment was written
by a 15-member committee that had a wide range of scientific
expertise needed for the task. Our charge focused primarily on
specific questions related to the Agency's approach to the IRIS
assessment. But beyond these charge questions, the committee
assessed the processes underlying the development of the draft
and made suggestions about the process generally followed by
EPA in developing the IRIS assessments. We were not charged or
constituted to carry out an independent review of the evidence
on formaldehyde.
To do its job we reviewed the 1,000 page, approximately,
draft assessment and key literature and determined whether
EPA's conclusions were supported on the basis of that
assessment and the literature reviewed. Much of our report is
directed at providing constructive comments and recommendations
on improving this draft specifically following our charge.
That said, we felt that we could not address our charge
without considering the methods and structure of the document
as a whole and in responding to its charge questions, the
committee found some recurring methodological problems that are
cut across components of its charge.
Consequently, we commented on the general methodology of
the assessment in our second chapter and offered general
suggestions in chapter seven with regard to the processes used
by EPA. The general problems that we identified were not unique
and have been reported by other committees. I think those
problems have already received some comment. We found
relatively little documentation of methods and insufficient
clarity and transparency in how the evidence reviewed in the
report was related back to the weight of evidence guidelines.
We offered six specific recommendations with regard to how
the present draft could be completed and moved forward
satisfactorily. I will not go through these. They are listed in
chapter seven of our report. They are straightforward and could
be followed to bring the report to completion.
I will turn to our general comments and suggestions on
IRIS. As noted, we found general problems that we thought had
been persistent in looking at NRC reviews of other IRIS
reports. On the basis of lessons learned from the formaldehyde
assessment, we offered our suggestions for changes in the IRIS
development process that might help EPA improve its approach.
We recognized that EPA had already implemented the plan
discussed, released, and covered in the memorandum of 2009 from
Administrator Jackson.
We put together our own view of the underlying development
process and offered a several-page roadmap for changes in the
development process. The term roadmap was used because the
topics that need to be addressed are set out, but we did not
give detailed guidance. Each topic, in fact, would speak--would
need to be developed in further detail.
For each of the critical steps in the roadmaps there are
underlying processes that would need to be examined and
reconsidered. Our report provides further detail. We think that
change in the IRIS development process, the process by which
the drafts are developed, is feasible. We note as one example
of the largely-successful overhaul of the process used for the
National Ambient Air Quality Standards as an example. I have
personally watched the revision of that process and noted its
benefits.
In conclusion, thank you for the opportunity to speak with
you today, and I look forward to answering your questions.
[The prepared statement of Dr. Samet follows:]
Prepared Statement of Dr. Jonathan M. Samet, MD, MS, Professor and
Flora L. Thornton Chair, Department of Preventive Medicine, Keck School
of Medicine, University of Southern California; and Chair, Committee to
Review EPA's Draft IRIS Assessment of Formaldehyde, National Research
Council, The National Academies
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Chairman Broun. I want to thank the panel, all of you.
Reminding Members the committee rules limit questioning to
five minutes each. The chair at this point will open the round
of questions.
The chair recognizes himself for five minutes.
EPA announced changes to the IRIS process 2 days ago. In
that announcement EPA indicated that it signed an MOU with the
California Environmental Protection Agency's Office of
Environmental Health Hazard Assessment to--in order to
cooperate in the development of health assessments to encourage
data sharing, avoid duplication of effort.
Dr. Anastas, as a Georgian why should I be subject to
California's risk assessments? If states are doing this work,
why do we need IRIS? If IRIS assessments are better than state
assessment, why have California do assessments for EPA? If IRIS
isn't sufficient, why not rely on one own state assessment. Why
just rely on one own state assessment? Please explain this to
me why this isn't a backdoor attempt to implement California's
risk assessment policies on the rest of the Nation.
Dr. Anastas.
Dr. Anastas. Thank you very much, Mr. Chairman. I am very
happy that you asked that question because it gives the
opportunity to explain some misconceptions about what IRIS is.
IRIS assessments are not risk assessments. They are not
risk management actions. They are not regulations. They are
scientific assessments to understand the hazard, the underlying
toxicity of substances. So the information that would be being
shared between California and EPA is simply the underlying
scientific basis, the assessments that are done by using the
open scientific literature that is the basis of the science,
but in no way would these assessments be risk assessments,
California risk assessments, California regulations. These are
only the underlying scientific bases that would be shared and
the basis of these health hazard assessments.
Chairman Broun. Well, I have got some follow-up questions
to that that I will give you in writing to go forward, but just
in the sake of time, Dr. Samet, as chair of the National
Research Council committee that reviewed the EPA's draft IRIS
assessment on formaldehyde, the committee decided to devote an
entire chapter entitled, ``Roadmap for Revision.'' That
highlighted specific changes to improve the formaldehyde IRIS
assessment but also went a step further and offered
recommendation for improving the IRIS process in general.
Why did the committee decide to offer additional
recommendations to improve the IRIS process? What letter grade
would you give EPA for its formaldehyde assessment, A being
excellent and F being a failure? And how about for the four
other assessments that NAS has reviewed since 2005?
Dr. Samet. The committee in its chapter seven wanted to
give very specific guidance to the Agency on how to bring the
formaldehyde assessment to completion. That was the six
recommendations. The document, the draft assessment involves a
number of underlying processes that have a generality to them,
pulling together all the evidence, reviewing it, and evaluating
it. And as we looked at the assessment, we found weaknesses
which we documented in how those processes had been put into
place and carried out.
We felt that it was important to give the specific
suggestions but also to provide general guidance on what needed
to be done to help improve not only this IRIS assessment but
hopefully future ones. As you noted, the National Research
Council has reviewed other major IRIS assessments in the last
decade and have found deficiencies in those documents.
Now, I will say the committee was not asked to give a
letter grade. I certainly couldn't give an A. I probably would
be, Paul, sorry, a little pressed to give a B, and let us say
we would certainly give--we will give a passing grade here, and
I am not sure, and if I give a too-low grade, I know they will
come back and ask me to revise it.
Chairman Broun. Okay. Thank you, Dr. Samet.
My time has just about expired, so I will recognize Ms.
Edwards for five minutes.
Ms. Edwards. Thank you, Mr. Chairman, and thank you to our
witnesses this morning.
Dr. Samet, your panel laid out certain challenges for EPA
to take up to make the formaldehyde assessment stronger. Your
panel did not recommend, however, that EPA bring that revised
assessment back to the Academy for another round of review but
to finish it and finalize it.
Do you have confidence that EPA can successfully address
the issues raised by your panel regarding how to strengthen and
clarify the formaldehyde assessment?
Dr. Samet. As a first comment, of course, an Academy panel
can't recommend that something be brought back to the Academy,
and I think however the document is revised I suspect that EPA
will undertake further review. I think we were careful in
chapter seven to say specifically what should be done. These
changes as I noted in my testimony should be feasible, and they
are changes that--and revisions that the agency should be able
to make successfully.
Ms. Edwards. And Dr. Anastas, do you have confidence that
you will be able to make that assessment given the analysis by
the Academy?
Dr. Anastas. Yes. I think the important thing is we seek
out the type of input that we received from the National
Academy, we seek out from scientific experts, and we are very
confident that getting the kind of input, the kind of
recommendations, that we are able to follow through and
incorporate those suggestions.
Ms. Edwards. Thank you, and to follow on then, Dr. Samet,
the Subcommittee has received some testimony for this hearing
that suggests that the Academy should review every IRIS
assessment, then review every revised assessment after changes
are made following the NAS report. Would this be a difficult
thing for the Academy to take on, and what effort would it
require to review 20 IRIS assessments a year?
Dr. Samet. Well, I, you know, certainly I am now speaking
as chair of the committee and not in general with the Academy,
which I can't do. I think there are many ways to have
successful peer review. The Science Advisory Board of the EPA,
which I serve on, being one. The Academy being another. I will
say that now speaking individually, the effort involved in
completing this review was substantial as I have mentioned. A
15-member committee of volunteers working in four meetings in 8
months and producing a, you know, a report over 100 pages.
So substantial effort would be involved, and I think if the
full load of peer review were somehow placed before the
Academy, I am certain that that would stress the community of
scientists who carry out such reviews.
Ms. Edwards. Yes. I suspect that would be pretty
impracticable.
I wonder, Dr. Samet, you also provided a roadmap for EPA on
how you think the IRIS process could be improved, and your
panel apparently believed that EPA is actually capable of
implementing those changes that the agency decides make sense.
As chair of the Clean Air Science Advisory Committee at EPA
you have had such changes take place and then I will just use
the acronym, in the NAAQS process, and also as chair of CASAC
and those assessment processes, are there lessons that might be
learned here for IRIS?
Dr. Samet. Well, I think if you look at chapter seven of
our report we provided a case study of the revisions that were
made, and having participated in reviews of NAAQS standards now
for several decades and I think the process has become much
clearer, must more transparent, and much more efficient, and I
think it has worked. It took some time on the part of the
Agency and some interactions with CASAC, but I think an
improved process resulted.
Ms. Edwards. And I just want to be clear. Your report
contained examples of where your panel felt that the EPA got
the science wrong or failed to adequately communicate how they
evaluated studies and came to conclusions, but I couldn't find
anyplace where you imply that EPA purposely distorted the
science or their findings. Did you find any evidence at all of
purposeful deception or intentional manipulation on the part of
EPA?
Dr. Samet. Well, certainly as we addressed our charge, we
look carefully at how studies were selected and reviewed. I
think we certainly found many examples where we felt that EPA
had not communicated well or we could not follow their
methodology but nothing that I would regard as purposeful to
use your words.
Ms. Edwards. Thank you, and then lastly, we will hear
testimony today that argues that the Science Advisory Board
lacks independence because it depends on EPA staff. Doesn't the
CASAC also depend on EPA staff for its work?
Dr. Samet. Well, EPA, I am sorry, CASAC certainly is
supported by EPA staff. Our deliberations and discussions are
fully public, and I certainly don't see them as influenced by
EPA staff as we carry them out in the complete open.
Ms. Edwards. Does either CASAC or the Science Advisory
Board have, do you have any reason to believe that they lack
any kind of independence because they rely somewhat on EPA
staff?
Dr. Samet. Not in my experience. No.
Ms. Edwards. Thank you very much, and with that I yield.
Mr. Hultgren. [Presiding] I am going to yield myself five
minutes for some questions as well. So, Mr. Trimble, if I could
start with you, what would it take to remove the IRIS Program
from GAO's high-risk series?
Mr. Trimble. That is a challenging question. We are in the
process of working with the agency and OMB to discuss what sort
of steps we would like to see along that process. I think there
is no simple answer that is X and Y and Z. I think that we have
got a little bit more work to figure out all the steps.
Clearly from our prior work some of the steps they have
taken has moved the ball along in terms of restoring
independence, adding some transparency to the process, but
clearly a lot of work needs to be done in terms of being able
to address the large backlog that still remains, as well as to
be able to move ongoing assessments forward in a timely manner.
I think there is also the issue that is still lurking out
there regarding sort of the pent-up backlog of IRIS assessments
that the Office of Water and other parts of the EPA have not
put in requests because they know there is such a logjam
currently. So there are a lot of other hidden issues that we
haven't addressed yet, but we are in the process of planning
work.
Mr. Hultgren. Do you have any estimate on the timeline on
that?
Mr. Trimble. Well, we have meetings scheduled I believe
this fall with the Agency and OMB to sort of do a status
report, and you know, I am not, I don't have a timeline at this
stage.
Mr. Hultgren. Dr. Anastas, let me read one part of Dr.
Samet's testimony where he says, ``In the roughly 1,000 page
formaldehyde draft reviewed by the present committee, little
beyond a brief two-page introductory chapter could be found on
the methods for conducting the assessment. In fact, the
introductory chapter of formaldehyde is nearly identical to
that used in the IRIS assessments. Numerous EPA guidelines are
cited, but their role in the preparation of the assessment is
not clear. In general, the committee found that the draft was
not prepared in a consistent fashion. It lacked 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 estimates. The critical
summary sections that synthesized the evidence are variable and
too often brief or not present, and strength of evidence is not
characterized with standardized descriptors.''
How do you respond to that?
Dr. Anastas. The reason that the Environmental Protection
Agency seeks out the type of peer review, expert peer review
from whether it is our Science Advisory Board or the National
Academies is to get that exact type of review, that exact type
of input. We take those recommendations extremely seriously. We
think that those improvements are absolutely essential to
improving and finalizing this draft assessment. That is why we
seek it out. That is why we fully accept them. That is why we
are integrating them into our revision of the formaldehyde
assessment.
Mr. Hultgren. So what is your intention, I guess, with, I
mean, this is pretty significant what they have said, you know,
that it sounds like there was a pretty significant failure here
in the processes. What will happen to address those recognized
failures?
Dr. Anastas. I guess I look at it a little bit differently.
I view that as a success in the process. We seek out this exact
type of peer review in order to continuously improve this draft
document. When we write a draft document, we want that type of
input so that the final version that gets posted and is
available to the American public and beyond is of the highest
quality. That is why we accept those recommendations, and that
is why we will build them into our revision.
Mr. Hultgren. Okay. Dr. Samet, with my last remaining
minute here, in her testimony Ms. Steinzor takes exception to
your scolding of EPA staff in the April formaldehyde report by
saying, ``I wish that the NRC Committee had not adopted such a
haughty tone in scolding EPA staff.''
In responding to her observation can you provide us with
some context of how many reviews the Academy has done of other
IRIS assessments and how often you or other chairs repeated the
suggestions and recommendations that ultimately led to chapter
seven of the formaldehyde report?
Dr. Samet. Well, I guess I had not read the testimony or
seen the term, scolding. I think that our comments in chapter
seven are provided as recommendations and as positive help to
the Agency in trying to improve the process as Dr. Anastas
mentioned. I think probably, and I can look to my left and get
a little help, but this is probably the fifth review in the
last decade by a National Research Council committee of an IRIS
assessment. These have been the larger, more complicated
assessments, and I think in all of them there have been one or
more general comments about methodology and some specific
chapters on aspects of methodology with concerns expressed.
Mr. Hultgren. Thank you. My time is up.
I yield five minutes to Mr. McNerney.
Mr. McNerney. Thank you, Mr. Chairman. I thank the panel
for stepping forward this morning. I appreciate, Dr. Anastas,
the attitude that you have about looking for input from
independent sources. That is very important. As a scientist I
appreciate that, and I understand that the Office of Research
and Development relies on a board of scientific counselors to
help provide an independent evaluation of your programs. That
board did an assessment in 2008, and then again in 2010.
Later this morning we are going to hear that the IRIS
assessments are considered irrelevant and the department weak
in science. Can you tell us a little bit about the board and
what sort of people serve on it, their independence, and
summarize their observations for us, please?
Dr. Anastas. Yes. A number of years ago we sought to
establish the Board of Scientific Counselors to give us
independent reviews of our general performance, how we are
performing on the wide range of activities that the Office of
Research and Development undertakes. Specifically we asked them
to review the IRIS process, and these Members who are of the
highest quality from industry, academia, a broad spectrum of
people, looked at the IRIS Program and gave us tremendous
feedback, both constructive recommendations, as well as
recognizing the strengths.
Some of the quotes from the Board of Scientific Counselors
include, ``Internationally IRIS assessments are considered to
be of the highest quality and reliability.'' Another quote is,
``IRIS assessments are among the most heavily-peer-reviewed
documents produced by scientists anywhere.''
So there are tremendous strengths to the IRIS Program, but
we also need to recognize that even strong programs can and
must improve. I come from Boston where the Boston Red Sox
happen to be in first place right now, but they are always
seeking to improve. We will always engage in continuous
improvement because that is what scientists do.
Mr. McNerney. Was the Board's recommendations or are their
recommendations aligned more or less with the recommendations
from the National Academy?
Dr. Anastas. Yes.
Mr. McNerney. Thank you. Dr. Samet, why did the National
Academy undertake the assessment in the first place, and who
paid for that effort?
Dr. Samet. Well, the National Research Council was asked by
the Agency to carry out this review. I think there is a
somewhat long and complicated history about that request that
you are likely aware of, but the support for the review to the
Academies came from the Environmental Protection Agency.
Mr. McNerney. Did the National Academy feel that their
recommendations or that your recommendations should be
mandatory and enacted by the end of this year? Was that the
intent?
Dr. Samet. Well, the Academy, of course, makes--our report
provides its recommendations. These have no binding
requirements for the Agency. They are really peer review and
suggestions and comments that we make in the spirit that we
hope they will prove to be useful to the Agency as it revises
the document or if it chooses to undertake revisions to the
IRIS process itself.
Mr. McNerney. So, I mean, they weren't initially given as,
hey, you need to do this by the end of this year, or this is a
big problem. That wasn't the intent then, was it?
Dr. Samet. Well, an Academy committee would not make
recommendations in that spirit. I mean, again, the Academy is
an advisory to the government.
Mr. McNerney. Thank you. Mr. Trimble, you reported this
morning that the assessment, the IRIS assessment was
unresponsive. I think that is the word I heard a number of
times. What do you believe is the underlying cause for that
assessment for your unresponsive assessment?
Mr. Trimble. I believe the unresponsiveness I was referring
to was in response to our 2008 report where we made
recommendations to improve the process and then later in 2008,
they made changes formalizing the process which was essentially
no change. They institutionalized the things we had identified
as problematic. That process was then changed in 2009.
So the lack of responsiveness is to our prior
recommendations and one of the reasons we put the area on our
high-risk list.
Mr. McNerney. I mean, you didn't answer my question. What
do you think the underlying causes of that unresponsiveness?
Mr. Trimble. Well, at that time I believe OMB and the EPA
were committed to the procedures they had in place, and they
were--their position was that the OMB's comments and other
agencies' comments were deliberative and should not be put in
the public domain.
Mr. McNerney. Okay. My time has expired, but you never
really answered the question. Thank you.
Mr. Hultgren. I recognize Dr. Benishek for five minutes.
Dr. Benishek. Thank you, Mr. Chairman. Distinguished
Members of the panel, thank you for your time today. I know we
are here to talk about chemicals, and as a physician I have a
bit of experience with chemicals.
I would like to talk today about a chemical called
acrylonitrile or AN. It kind of has a funny name, and you
probably never heard of it, but we all come in contact with it.
As a physician I really haven't been aware that I was using the
compound, but it is around in medicine a lot. It is found in
everything from dialysis tubing to cell phones to computers and
golf clubs.
Recently the EPA released an IRIS assessment for AN with a
60-day comment period, and based on initial review of the draft
it doesn't seem to have a comprehensive objective review of the
science. The draft completely ignores many of the articles
published in reputable peer review journals, many with opposing
views.
I am concerned that the assessment will lead to burdensome
regulations in a variety of industries, you know, especially in
my district, plastics and boating industry, medical equipment.
I find it troubling that the Agency seems to spend a lot of
time and money accusing us in Congress to not--to ignoring
science but fails to follow some of its own advice.
Is the EPA's objective to review all critical published
scientific information when preparing these assessments,
whether or not the Agency agrees with the position? Dr.
Anastas.
Dr. Anastas. Thank you very much for the question. The
short answer to your question is yes. We--an essential part of
all of our analyses, speaking generally across all of the IRIS
assessments, is understanding the relevant, credible scientific
information and composing its assessments. Those assessments,
and I am speaking specifically to acrylonitrile right now, go
into an external peer review process where we get the reaction
to this draft assessment.
So if there are concerns about particular studies that may
not have been identified, considered, that those are caught
during this period in the peer review process.
Dr. Benishek. Well, the reason I am asking this is, you
know, apparently what this is, acrylonitrile review, there is
no mention of several other publications. I am looking at one
here. The International Agency for Research on Cancer, part of
the World Health Organization published a review that wasn't
cited. There is a review on AN in North Carolina Scientific
Advisory Board that wasn't cited. There was a review by an
independent peer review panel organized by TERA, the Toxicology
for Excellence and Risk Assessment. There are several
conflicting sources of information that aren't cited in the
review and I just want to understand how the committee decides
which studies to include in the review and which studies not to
include.
I mean----
Dr. Anastas. That is an excellent question. The process by
which studies are selected based on their relevance, their
credibility is something that as we have spoken about, is
always something that we are seeking to make clear, transparent
with these public meetings, with this public external peer
review. All of these comments are considered. That is why this
draft is going out for this public peer review.
I do want to clarify one thing that I mentioned earlier.
These assessments are not regulations. These assessments are
not risk assessments. These are the underlying scientific
characterization of the hazard.
Dr. Benishek. Well, it doesn't seem to me to, you know, I
have read the papers where you may have like 100 citations, and
just not having all the citations that are available doesn't
seem to make any sense to me. You know what I mean? Why some
are not listed I just don't get it, because, I mean, you just
put another citation in there. It makes sense to have comments
on both sides of the issue.
Dr. Anastas. Absolutely and that is why we have these
public sessions to consider all scientifically-sound, credible
information be part of these assessments.
Dr. Benishek. And yet these things that I cited weren't
included. So I just don't understand why not.
Dr. Anastas. If there were any scientific, credible,
independent studies that were not included, then this is the
process to ensure that all of them are included. This is why we
go to the external public peer review.
Dr. Benishek. So then are we going to include these studies
that I had mentioned to you in the future or reevaluate the
situation or what?
Dr. Anastas. Any literature, any study that is relevant,
sound, independent, scientifically credible. Anything that is--
that meets those criteria would certainly be included.
Dr. Benishek. Well, great. Then we will have the committee
forward these studies to you, but maybe they can be included in
your evaluation.
Dr. Anastas. And the timing is excellent, because this is
the external peer review and public assessment comment.
Dr. Benishek. All right. Thanks.
I yield back my time.
Chairman Broun. The gentleman's time is expired.
Now I recognize Mr. Miller for five minutes.
Mr. Miller. Thank you. This is an issue, the IRIS System,
that this Subcommittee considered when I was chair of the
Subcommittee. We have thousands of chemicals that are in
widespread use. We really do not know what the public health
consequences are of exposure to those chemicals. We have about
700 new chemicals entering the marketplace every year. We have
no idea what most of those do to anybody. We have got cancer
clusters and clusters of birth defects all over the country we
know have got to be the result of exposure to something, and we
don't know what, and the IRIS System is supposed to be how we
assess the risk of exposure to chemicals.
But despite all that because of the system that was in
place there are only about three new or revised assessments
being issued a year, and there was ample evidence of political
interference and a great deal of influence by the industries
that made those chemicals or use those chemicals.
I have three charts I would like to show, and I believe
somebody is, yes, standing by, and I hope the witnesses can see
these.
[Chart]
This is actually a schematic of the process that the Bush
Administration inherited from the Clinton Administration. Well,
I believe it was in effect for most of the Bush Administration,
and then a step or supposedly this was streamlined.
Can we show the second?
[Chart]
Yeah. That is the streamlined version. Now, at the time I
said that I was reminded of Chico Marx quote, ``Who are you
going to believe, me or your own eyes,'' that that was a
streamlined version of the process that had existed before.
What that did, however, was put OIRA in the middle of the whole
process.
Now, Dr. Anastas, when Chairman Broun scolded you for not
getting your testimony in on time, he said you had completed
it, but you had to get it reviewed. Was that a review by OMB?
Dr. Anastas. All testimony is reviewed by OMB.
Mr. Miller. Okay, and that is where the holdup was? Well, I
know you don't want to criticize OMB. Is OIRA a part of OMB?
Dr. Anastas. Yes.
Mr. Miller. Okay. Thank you, and that is the system that
slowed it, that appeared to slowed it down greatly. Now, Mr.
Trimble, the GAO has been in--very involved in all this in
reviewing the IRIS System, and you were not suggesting--well,
let us now go to the third slide.
[Slide]
And that is the slide that supposedly is streamlined, and
actually it appears that you could believe your own eyes that
that is streamlined. You are not suggesting we go from that
back to the previous system, are you?
Mr. Trimble. No, sir. The opposite.
Mr. Miller. Okay. The opposite. All right.
Dr. Samet, you reviewed a lot of OIRA's assessments. You
looked at, let us see, formaldehyde, perchlorate, dioxin,
trichloroethylene. I am not on of the committee's doctors. And
tetrachloroethylene.
Which of those systems were those assessments done under?
Dr. Samet. I would, I can't exactly answer that. I mean, I
would have to look at the timing of each of those and when they
were done. They were mostly done over the last 5 or six years,
so I guess that would be back with your 2004, 2008 slide.
Mr. Miller. Well, Dr. Anastas, can you answer that
question? Were any of these assessments that the academies have
found fault with been performed under that system?
Dr. Anastas. No.
Mr. Miller. They were all under the previous systems?
Dr. Anastas. Correct.
Mr. Miller. The streamlined previous systems?
Dr. Anastas. Correct.
Mr. Miller. All right, and, again, although Susan Dudley,
who headed OIRA at the time, sat right there, raised her hand,
right hand, took the same oath that you all had, and said that
there was never any--they never really substituted their
judgment on science for EPA. There was a huge amount of
evidence that that happened routinely.
The impression from that period and from our hearings
before is that the work EPA was doing to get a risk assessment
through this streamlined process was one performed under fire,
under hostile fire from the industries that produced the
chemicals and from the industries and the agencies of
government that used the chemicals. Is that correct?
Dr. Anastas. Was that the characterization?
Mr. Miller. Yes, sir.
Dr. Anastas. That was the characterization.
Mr. Miller. Okay, and is it possible that some of the fault
that the academies have found with EPA's work in this is the
result of the fact that the people performing the work felt
they were under fire and were trying to anticipate every
possible criticism?
Dr. Anastas. There are those who have characterized that
that way. Yes.
Mr. Miller. Okay. Would you be one of those who
characterizes it that way?
Dr. Anastas. I think the excellent scientists who dedicate
their professional lives to this have felt under a tremendous
amount of pressure from different sources. Correct.
Mr. Miller. Okay. My time has expired, Mr. Chairman.
Chairman Broun. Thank you, Mr. Miller. Nice seeing you stay
within five minutes. No, I said that in all sincerity.
Now the Chairman recognizes Mr. Rohrabacher for five
minutes.
Mr. Rohrabacher. Thank you very much, Mr. Chairman.
Yeah. I guess we have seen lots of examples where
scientists have been put under pressure, especially during this
investigation of global warming and such issues where our
scientists were denied grants because they did not believe in
global warming's theory, which we heard reports of across the
board for years in this committee.
So we know that there are certain advocacy elements within
the scientific community that are willing to pressure other
people within the scientific community. It is sort of like
tenure in college for the college professors, of course, would
never think about trying to control what type of people are
hired onto their departments, but we all know that happens,
don't we?
I would like to ask in terms of how this affects the
scientific questions that we are dealing with today, is--and I
certainly would--I will take you, I will address you, you are
the head man. Are the scientists who are involved with this
risk assessment program, are they--are steps taken to make sure
that they have not been part of advocacy groups prior to their
involvement with this program?
Dr. Anastas. I can't say that I do not investigate the
backgrounds of scientists.
Mr. Rohrabacher. Okay. So there is no background check to
see if a scientist has been involved with an advocacy program
or actually been hired, perhaps, by an advocacy organization
prior to him getting involved and his decision making being
trusted by your organization?
Dr. Anastas. The only background check that would be done
is for the scientific excellence.
Mr. Rohrabacher. Okay. So you could have someone who is
very etiological, very, very etiological and even being hired
by groups that are just adamant about what they believe, and
that person could still be someone who you are relying on for
their judgment not to be impaired.
Dr. Anastas. I can only say that we hire people for their
excellence in science, that demonstrated excellence in science.
Mr. Rohrabacher. Uh-huh, and you don't take into
consideration if that person had been involved in an
organization that perhaps that organization is so committed to
a position that it reflects anyone who could associate. You
know, there are certain groups that have a position, whether
they are against what you believe or for what you believe, but
they are so adamant that we know that that might indicate the
person doesn't have an open mind towards certain issues.
But that is not taken into consideration for hiring
someone?
Dr. Anastas. You raise an excellent point, Congressman,
because at the essence of scientific excellence is objectivity.
Mr. Rohrabacher. Correct.
Dr. Anastas. And so when I use the words, scientific
excellence, embedded in that definition would be objectivity.
Mr. Rohrabacher. Okay, and however, someone's affiliation
with certain advocacy groups is not something that you would
look at to determine their objectivity?
Dr. Anastas. If a person skewed their science in order to
meet ideological ends, that would be antithetical to scientific
excellence.
Mr. Rohrabacher. And there is no organizations that you
believe that just an association with that organization would
say, well, maybe that person is just too much involved with
advocating a position to be able to come on board?
Dr. Anastas. I would only say that we need to evaluate the
scientific excellence and the objectivity and other litmus
tests, background checks----
Mr. Rohrabacher. Right.
Dr. Anastas. --or----
Mr. Rohrabacher. Now, what we have seen too much of is
scientific excellence is dependent on whether someone agrees
with me or not, and that is what we have seen over and over and
over again by the liberal establishment here in this city in
dealing with scientific issues. And I certainly would think
that if we have certain people that are committed to a position
and they are involved with organizations that are committed,
that that should be taken into consideration when giving them
responsibility to assess whether or not something is
scientifically viable or not.
Let me ask you another thing.
Chairman Broun. The Chairman's time has expired.
Mr. Rohrabacher. Oh. Pardon me.
Chairman Broun. Thank you, Mr. Rohrabacher.
I now recognize Mr. Clarke for five minutes.
Mr. Clarke. Thank you, Mr. Chairman. My question is more
than likely for Dr. Anastas abut anyone else could feel free to
answer. It is really a basic one.
I just wanted to get clarification again between the
difference between an IRIS scientific assessment and a complete
risk assessment, if there are certain elements in a risk
assessment that the IRIS assessment does not address. And then
ultimately how you would compare the IRIS assessment in time
development and in substance to the ultimate regulatory
proposal that is issue?
Dr. Anastas. Certainly and thank you very much for the
question.
The information that is provided in an IRIS assessment is
an essential and key part that feeds into a risk assessment.
However, there is the hazard characterization. In order to come
up with the risk assessment, the risk probability, you need
exposure data. So the exposure of an individual to the
substance through a variety of roots, whether it is children,
it is breathing in air, it is ingested in the water, that--
those components coming together are part of the risk
assessment process, which then feeds into the risk management
alternatives. Those are the regulatory determinations that are
carried out by our program offices, our Office of Water, our
Office of Air, to take into account a wide variety of other
factors, including everything from socio, economic, other
considerations, technological feasibility of various risk
management options.
And so while the IRIS assessments and the information they
provide is a critical piece, it is significantly removed from
the regulatory process.
Chairman Broun. Thank you, Mr. Clarke.
Now recognize the full committee Chairman, Mr. Hall, for
five minutes.
Chairman Hall. Thank you, Mr. Chairman. Inasmuch as I don't
know what questions have been asked or answers elicited and as
much as I probably wouldn't believe anything any of the three
of you say, I will yield back my time.
Chairman Broun. I can't believe it. Okay.
Mr. Sarbanes is still down there. I yield Mr. Sarbanes five
minutes.
Mr. Sarbanes. Thank you, Mr. Chairman. I appreciate it.
Thank your for your testimony.
I always start these hearings, these hearings being ones
that are about chemicals and the risks that chemicals pose out
there and our efforts to try to get a handle on that and get
more information by observing it, if the average member of the
public understood how little information and knowledge we have
about the chemicals that are being put out there in the stream
of commerce, in the natural streams, and so forth, they would
be amazed and appalled. I think they have the expectation that
our level of knowledge is much, much higher than it is, and a
lot of the delay that we see in the kind of regulation and
oversight and assessment is something they wouldn't imagine
would be happening in the United States of America in the 21st
century. So I don't know who is watching this hearing out there
in the public, but I hope they spread the word on this.
I was looking at this silver book, as it is so called, and
on the back it talks about how risk assessment has become a
dominant public policy tool for making choices based on limited
resources to protect public health and the environment. So we
talked a lot about that.
However, risk assessment is at a crossroads, it says.
Despite advances in the field risk assessment faces a number of
significant challenges including lengthy delays in completing
complex risk assessments, lack of data leading to significant
uncertainty in risk assessments, and many chemicals in the
marketplace that have not been evaluated, and emerging agents
requiring assessment, which is a pretty good encapsulation of
the testimony and exchange that we have been having here this
morning.
I think you all recognize that, and I see the three of you
working in concert to try to improve the process, improve the
reliability of the risk assessment process, and Dr. Anastas, I
appreciate your lack of defensiveness with respect to the
assessments and evaluations that have been done that you invite
in terms of the IRIS process, and you are getting some good
constructive input.
Then commenting on the silver book, this--the back flap
here says, ``Science and decisions,'' which is the name of the
silver book, ``makes practical scientific and technical
recommendations to address these challenges,'' i.e., the ones
just referred to.
Can you speak to the value of this? This is a follow up on
an earlier framework known as the red book, as I understand it
it complements it, but can you speak to the value of this, and
then Dr. Samet, I would like to get your perspective on it as
well. Thank you.
Dr. Anastas. Thank you very much, Congressman, for the
question because the so-called silver book was carried out by
the National Research Council and chaired by a very well-
respected professor at Johns Hopkins University named Tom Burke
and provided some excellent framework for how we need to
continuously improve our risk assessment processes, how we need
to think more broadly if we are going to ensure that the risk
framework is as strong as it needs to be.
As Science Advisor of the Agency, I have the honor of
chairing the Science Technology and Policy Council. Adopting
the recommendations in the science book is something that is
going on in real time, moving ahead so that across the Agency
the findings of the silver book are able to be incorporated.
Mr. Sarbanes. Thank you. Dr. Samet.
Dr. Samet. I think the silver book was an important
updating and broadening of the concepts that were in the so-
called red book.
I would also bring your attention to one other report that
came out from the National Research Council around the same
time, Toxicity Testing for the 21st Century, which laid out, I
am sorry to use the word again, but a roadmap or a blueprint
for how to address the problem highlighted in the comments on
the back of the silver book. We need to have a way to test with
validity the many chemicals coming into the marketplace. And
the proposal in that document is how do we use our new science
to try and address this question with some certainty, dealing
with the hundreds of chemicals whose risks we are uncertain
about as they come into the marketplace, using the best science
possible.
So I think that together those two reports do set out a,
hopefully a new approach for the future.
Mr. Sarbanes. Thank you. I yield back.
Chairman Broun. The gentleman's time has expired. Thank you
so much, Mr. Sarbanes.
I want to thank the panel for you all's testimony and your
answering questions, particularly in an expeditious manner, and
I want to thank the committee Members for also asking their
questions in an expeditious manner.
You will be excused. Members may desire to submit written
questions, and I trust that we will get replies in a timely
manner from you all, so you all are excused, and thank you for
your testimony today.
And if the second panel will expeditiously also take their
seats.
At this time I would like to welcome and introduce our
final panel of witnesses. First is the Honorable Calvin Dooley.
He is President and CEO of the American Chemistry Council.
Congressman Dooley previously represented the 20th
Congressional District in California. We have Ms. Rena
Steinzor, who is Professor at the University of Maryland School
of Law and Founder and President of the Center for Progressive
Reform. We have Dr. Gail Charnley, is Principal at HealthRisk
Strategies. Dr. Charnley is an internationally-recognized
scientist who has served on several advisory committees,
including peer review panels for the EPA and FDA, the
Presidential Congressional Commission on Risk Assessment and
Risk Management, and is currently on the National Academy of
Sciences Board on Environmental Studies in Toxicology. The
Honorable Chris Bollwage is Mayor for the City of Elizabeth,
New Jersey, a position he has held for the past 18 years. I am
sorry. You have got one of the hardest jobs in politics. Mayor
Bollwage also serves as Chair of the Conference of Mayors
Brownfields Task Force.
As our witnesses should know, spoken testimony is limited
to five minutes each, and please try to maintain that five
minutes. After which Members of the committee will have five
minutes to ask each questions. I ask the committee Members to
please be mindful of the time. Your written testimony will be
included in the record of the hearing. It is the practice of
the Subcommittee on Investigations and Oversight to receive
testimony under oath. Do any of you have objections to taking
an oath?
Let the record reflect that all witnesses are willing to
take an oath.
You also may be represented by counsel. Do any of you have
counsel here today?
Let the record reflect that none of the witnesses have
counsel. I think Congressman Dooley, you indicated you do not.
Okay. That is great. If all of you would please now stand and
raise your right hand. Do you solemnly swear or affirm to tell
the whole truth and nothing but the truth, so help you God?
Thank you, and you may be seated. Let the record reflect
that all the witnesses participating have taken the oath.
I now recognize our first witness, Congressman Dooley, for
five minutes.
TESTIMONY OF CALVIN DOOLEY,
PRESIDENT AND CHIEF EXECUTIVE OFFICER,
AMERICAN CHEMISTRY COUNCIL
Mr. Dooley. Good morning Mr. Chairman and Members of the
committee. I appreciate the opportunity to be here today to
speak to the pressing need to fix the Environmental Protection
Agency's Integrated Risk Information System or IRIS.
IRIS is one of the most important programs that EPA uses to
assess the safety of chemicals. But in recent years, IRIS
frequently has been criticized for failing to meet high
standards of scientific inquiry, transparency, and quality.
I have outlined several examples of flawed IRIS assessments
in my written testimony, but the recent peer review of
formaldehyde is perhaps the most telling. After EPA's draft
IRIS review of formaldehyde was scrutinized, EPA asked the
independent experts at the National Academy of Sciences, NAS,
to review its findings.
The NAS review questioned the evidence IRIS used to support
its conclusions that a link exists between the exposure to
formaldehyde and certain types of leukemia, stating,
``Conclusions appear to be based on a subjective view of the
overall data, and the absence of a causal framework for these
cancers is particularly problematic given the inconsistencies
in the epidemiologic data, the weak animal data, and the lack
of mechanistic data.''
The NAS report also devoted an entire chapter to needed
program improvements. NAS summed it up by saying, ``The
committee is concerned about the persistence of problems
encountered with IRIS assessments over the years, especially
given the multiple groups that have highlighted them. If the
methodologic issues are not addressed, future assessments may
still have the same general and avoidable problems that they
highlighted in their report.''
While IRIS is a complex program that examines complex
issues, the problems can be boiled down to two things. First,
IRIS does not reflect modern scientific methods or 21st century
knowledge about how chemicals interact in the body at different
levels of exposure. Rather, IRIS continues to rely too heavily
on outdated assumptions that were formulated in the 1970s.
Second, there is little independence in the program's peer
review process. EPA controls each step of the review process
and ultimately decides which recommendations from peer review
groups to act upon and which to ignore.
IRIS needs a comprehensive overhaul to ensure that
assessments are based on proven scientific data and modern
scientific understanding. The peer review process must be
enhanced so there is an honest broker to ensure that IRIS
assessments are reviewed independently and recommendations from
peer reviews and public comments are adequately incorporated.
While EPA announced some process changes earlier this week
and we are pleased that EPA has done so and that they recognize
the program must be reformed, we remain concerned about the
lack of a truly independent peer review process. ACC continues
to believe that NAS should review all pending IRIS assessments
to ensure their quality until the systematic problems with the
program are fixed. And I will stress that. Until we have the
confidence that the systematic problems are fixed.
If the improvements announced this week are effective, that
will validate--be validated by NAS reviews. Anyone who looks at
the evidence, whether you are a state regulator, a public
health official, or a furniture maker can see that the IRIS
Program is broken. Getting it right is in the interest of us
all. The current deficiencies and the lack of confidence in the
program cause delays and unnecessary costs. Flawed assessments
create public confusion, unwarranted alarm, unnecessary product
de-selection, and litigation, all of which can put jobs and
innovation at risk without a sound scientific basis.
By making needed changes to IRIS we can minimize delays and
provide answers to the public, public health professionals, and
industry in a far-more credible and timely way.
Thank you very much for the opportunity to testify, and I
look forward to taking your questions.
[The prepared statement of Mr. Dooley follows:]
Prepared Statement of The Honorable Calvin Dooley, President and Chief
Executive Officer, American Chemistry Council
Mr. Chairman and Members of the Committee. I am Cal Dooley,
president and CEO of the American Chemistry Council. I appreciate the
opportunity to be here today to speak to the pressing need to fix the
Environmental Protection Agency's (EPA) Integrated Risk Information
System, or IRIS.
Shortly after taking office, President Obama committed that science
and the scientific process would guide decisions of his Administration.
We at the American Chemistry Council (ACC) welcomed this pledge,
because we agree that credible, accurate, modern science must form the
foundation of regulatory decisions.
Three years later, though, our confidence in the Administration's
commitment to scientific integrity in the regulatory process has
eroded. This is in large part due to troubling inconsistencies,
inefficiencies and lack of transparency in the federal system for
assessing the safety of chemicals.
IRIS is one of the most important programs EPA uses to assess
chemical safety. It serves as a leading source of health risk
information for other federal, state, and international regulatory
bodies. But over the years, the program has been repeatedly criticized
for failing to consistently meet high standards of scientific inquiry,
transparency and quality.
It is time to fix the IRIS program to protect health, safety and
the environment and preserve the ability of American industry to
innovate, compete and create jobs.
Several examples illustrate the shortcomings of the IRIS program:
Formaldehyde
Perhaps the most telling example can be found in the recent case of
formaldehyde. Formaldehyde has been the subject of scientific study for
years. Numerous organizations including the World Health Organization
have concluded that a large body of evidence shows that the levels of
formaldehyde most people encounter do not cause adverse health effects.
Despite this, EPA completed its IRIS review of formaldehyde in 2010,
asserting that a link exists between exposure to formaldehyde and
certain types of leukemia. EPA's conclusions quickly came under
scrutiny. To provide clarity, EPA asked the National Academies of
Science (NAS) to convene an expert Committee to review its findings.
The NAS Committee issued its report earlier this spring and in it,
they questioned the evidence EPA used to support its conclusion. In the
report NAS stated:
``Conclusions appear to be based on a subjective view of the
overall data, and the absence of a causal framework for these cancers
is particularly problematic given the inconsistencies in the
epidemiologic data, the weak animal data and the lack of mechanistic
data.''
In the report, the NAS Committee also offered a harsh critique of
the IRIS program in general. In fact, the expert committee felt so
strongly that they included an entire chapter devoted to the program
improvements that they saw as ``critical for the development of a
scientifically sound IRIS assessment.'' The NAS report stated:
``The committee is concerned about the persistence of problems
encountered with IRIS assessments over the years, especially given the
multiple groups that have highlighted them. If the methodologic issues
are not addressed, future assessments may still have the same general
and avoidable problems that are highlighted here.''
Hexavalent Chromium
In 2009, industry undertook a multi-million dollar mode-of-action
research program to develop new data that EPA could use to assess the
risk that Cr6 poses from low-level, environmentally-relevant exposure
through drinking water. The research was directly responsive to the
data needs of the Agency, and EPA staff was consulted during the
process of developing the research plan.
Despite the pending research, due later this year, the agency
significantly accelerated its timetable for the hexavalent chromium
IRIS assessment, publishing a draft in late 2010. EPA's independent
peer review group expressed significant concerns about the scientific
quality of the draft assessment, citing knowledge gaps, including those
that could be filled by the industry research. EPA still intends to
finalize the IRIS assessment by the end of September, about the same
time that the new research should be completed.
With this intensive schedule, we are concerned that EPA will not
fully incorporate the extensive comments from EPA's peer review group.
Failure to address the peer review comments and include the new
research findings will result in a risk assessment that will be out-
dated and inaccurate as soon as it is released.
Dioxin
The IRIS program first published its draft assessment of dioxin in
the mid nineteen-eighties, but it remains a point of contention today.
Specifically, both EPA's own Science Advisory Board (SAB) and the NAS
criticized the model that EPA used in the IRIS assessment to evaluate
cancer risk.
In 1995, the Scientific Advisory Board told the IRIS program that
it was inappropriate to extrapolate using a linear low dose method to
estimate cancer risk to humans. EPA revised the assessment, but failed
to follow the SAB directive.
In 2006, after reviewing EPA's 2003 reassessment of dioxin, the NAS
concluded--unanimously--that a non-linear method (as opposed to a
linear dose-response model) should be used to extrapolate for
estimating cancer risk to humans.
Despite the National Academy's 2006 recommendation, EPA's
reanalysis of key issues in the dioxin assessment again used a linear
dose-response model.
Sixteen years after EPA was given a clear recommendation by the SAB
peer review to use a model that reflects knowledge of mode of action in
the dioxin IRIS assessment, IRIS continues to push an out-dated risk
assessment model for dioxin. Based on the expert review in 1995 and
2006, IRIS has no scientific justification for doing so.
Inorganic Arsenic
In a case similar to dioxin, EPA defaulted to a linear no-threshold
model in its draft IRIS assessment of inorganic arsenic, disregarding
the 2005 EPA peer review panel recommendation to consider a threshold
model. This is critical because applying the proposed model would
result in naturally occurring levels in many soil and water supplies
around the country being considered ``unacceptable'' by EPA guidelines.
If this draft IRIS assessment stands, it could lead to confusion,
undue concern and unnecessary costly modifications to water treatment
systems, the abandonment of water sources, and the forced
identification of alternative water supplies. And it could create the
impression that typical arsenic levels in foodstuffs such as rice,
fish, grapes, and other common foods could be cancer-causing.
These examples clearly demonstrate that IRIS has failed to evolve
with the significant progress that has been made in the science and
technology of chemical risk assessment.
Over the years, researchers and health professionals have gained a
greater scientific understanding of the human body; the ways chemicals
can interact with the body at different levels of exposures; and how
that knowledge applies to determine the safety of chemical uses.
However, IRIS risk assessments lag behind these advances and rely too
heavily on outdated assumptions formulated in the 1970s.
For example, IRIS assessments of carcinogenic responses in high-
dose animal studies typically take the most conservative default
approach, rather than applying relevant mode of action and real world
exposure information to more accurately show the risk to humans.
In effect, IRIS has clung to risk assessment approaches that assume
that there is no safe dose or threshold--even when experts tell the
program otherwise--as was the case with dioxin and inorganic arsenic.
IRIS's failure to integrate this information into program decisions
undermines the development of new science-based risk assessment
practices, wastes investments in research and undercuts effective
public health science policy.
Not only has IRIS failed to keep pace with modern science, the
program lacks the scientific accountability needed to be considered
objective and credible.
There is little independence in the IRIS program's standard peer
review process: the IRIS office controls the development of the
assessment, the design of the peer review charge questions, and the
evaluation of the peer review findings. Ultimately, the IRIS program
itself decides which recommendations from peer review groups to act
upon and which to ignore. As we have seen in the case of dioxin, the
IRIS office has exhibited steadfast reluctance to upgrade the
assessments in response to the demands of independent peer reviewers.
To restore credibility to the program, there must be an honest
broker to ensure that EPA adequately considers and incorporates changes
from peer reviews and public comments. That is why ACC has called for
the NAS to review all pending IRIS assessments. Unfortunately, EPA
dismissed this suggestion saying, ``IRIS is a model for openness,
transparency, scientific integrity and scientific quality.''
Anyone who looks at the evidence, whether you are a state
regulator, a public health official or a furniture maker, can see that
the IRIS program is broken and fails to effectively support EPA's
mission to protect public health and the environment.
EPA's refusal to fully acknowledge and rectify the many problems
with the IRIS program calls for Congress to step in.
EPA must be required to take immediate steps that will ensure
pending IRIS assessments meet the highest standards of accuracy and
scientific integrity:
IRIS assessments in progress should incorporate the
recommendations described in Chapter 7 of the NAS panel formaldehyde
scientific peer review report where they are applicable;
IRIS assessments that are currently in draft form (or
that will be issued as draft for public comment and peer review in 2011
and 2012) should be submitted to the NAS for independent scientific
peer review; and,
Revised IRIS assessments developed by the Agency must be
evaluated (preferably by the same NAS panel that conducted the initial
peer review) to ensure that the peer review panel's findings and
recommendations have been adequately and transparently addressed.
While NAS review of pending assessments will help improve the
program in the interim, EPA must also initiate a comprehensive overhaul
of the program to make IRIS effective and efficient in the future:
Assessments must rely on proven scientific data instead
of outdated assumptions;
EPA must establish consistent data evaluation methods;
EPA must adopt a consistent weight of evidence framework,
based on transparent, rigorous evaluation methods, so that all
available data can be taken into account, with the best and most
relevant science given the greatest weight;
Assessments should be based on 21st century knowledge of
how chemicals interact with the human body;
EPA must adopt proven approaches for evaluating cause,
effect and uncertainty as part of IRIS assessments; and,
EPA must enhance public comment and independent
scientific peer review processes.
The IRIS program is a critical part of our chemical regulatory
system, and it must be improved. The current deficiencies and lack of
confidence in the program are resulting in delays and unnecessary costs
as the frequent shortcomings in draft assessments are addressed. Flawed
assessments have significant consequences in and of themselves. They
create public confusion, unwarranted alarm, unnecessary product de-
selection and litigation, all of which ultimately can put jobs at risk
without sound scientific basis.
To be clear, ACC is not suggesting that IRIS assessments be
suspended or delayed. We are proposing concrete ways to make pending
and future reviews more accurate and more credible. Making the
necessary changes will ensure that the program completes assessments
more efficiently and provides answers to the public, public health
professionals and industry in a far more timely way. Thank you very
much for the opportunity to testify. I look forward to taking your
questions.
Chairman Broun. Thank you, Congressman.
Now I now recognize our next witness, Ms. Steinzor. You are
recognized for five minutes.
TESTIMONY OF RENA STEINZOR,
PROFESSOR, UNIVERSITY OF MARYLAND SCHOOL
OF LAW AND PRESIDENT, CENTER FOR PROGRESSIVE REFORM
Ms. Steinzor. I appreciate the opportunity to testify on
one of EPA's most important and foundational programs. These
days the more important a public health program, the more
likely it is to be the subject of relentless, intemperate, and
unjustified attacks. IRIS is no exception. The program is a
serious, well-informed, and carefully-conducted scientific
effort to synthesize existing research in order to set
reference doses for the worst toxic chemicals. But industry
lobbyists have mischaracterized it as an anti-scientific effort
to demonize such ostensibly benign substances as arsenic,
formaldehyde, and dioxin. Arsenic, formaldehyde, dioxin.
Really?
Without IRIS EPA would be hard pressed to develop standards
for the control of emissions of toxic chemicals that cause
brain damage, cardiovascular illness, reproductive dysfunction,
cancer, and a range of other diseases. Delaying IRIS profiles
has and will endanger public health, an intolerable outcome
that this committee must not allow to happen.
The simple fact is that everyone attending this hearing
would be hard pressed to come up with more than a handful of
toxic chemicals that were exonerated by additional research.
The overwhelmingly powerful historical trend moves in the
opposite direction. As the research accumulates, chemicals
prove to be more toxic than we first imagined, often by several
orders of magnitude.
From the American public's perspective the central and
urgent problem with IRIS is not that it rushes to judgment on
toxic chemicals. Far from it. The problem is that repeated
rounds of redundant peer review and interagency comment allow,
in fact, invite chemical manufacturers to slow the program to a
crawl. Because of these delays IRIS is woefully incomplete.
Profiles are missing for at least 255 high-priority
chemicals. The 2008 GAO report warned that the Bush
Administration's approach to IRIS left the database at risk of
becoming obsolete. To its credit, the Obama Administration
reviewed IRIS in an effort to speed the production of
assessments. Although these changes are a definite improvement,
the rate of production is still slow enough that EPA will not
catch up with its existing backlog for another 55 years.
Chemical manufacturers and their allies, most notably
federal agencies like the Department of Defense and NASA, have
targeted IRIS as a chokepoint for regulation. Anyone who has
followed the IRIS Program closely for many years cannot help
but find their recent denunciations of the program disingenuous
and surreal. They have been in the thick of the action since
IRIS began, making their case to IRIS staff, more senior EPA
officials, sympathetic federal agencies and departments, and
the White House Office of Information and Regulatory Affairs.
In fact, the reason why IRIS profiles have ballooned into
unmanageable length is the reaction of EPA staff to constant
harassment by industry participants.
The remedies proposed by the chemical industry will make
these problems worse, not better. One of the most intemperate
proposals is that OIRA increase its oversight of the program.
OIRA is staffed almost exclusively by economists who have no
better idea of what constitutes a good RfD than any other
layperson.
A second demand is that the NRDC be brought in to review--
NRD be brought in to review all IRIS assessments. The academic
scientists who serve on NRC review committees receive
compensation that does not nearly pay for their time. Instead,
they are motivated by a commitment to public service and the
prestige of serving on a panel to consider cutting-edge
scientific issues. Using NRC to run around double-checking
routine government work would disrupt this delicate balance,
damaging the National Academies as well as EPA.
The final example of overreaction is the rider proposed for
EPA's appropriations bill that would bar EPA from moving
forward with future assessments until all existing assessments
had been revised to conform to the NRC's advice about the
formaldehyde assessment. This proposal would paralyze the IRIS
Program for the foreseeable future by forcing its staff to
engage in a massive round of paper shuffling.
The chemicals we are talking about here are the worst of
the worst, produced in amounts of millions of pounds annually.
The victims of further IRIS delays are neither the companies
that makes these chemicals, nor the scientists engaged in the
endless research, but rather Americans and their health.
Thank you.
[The prepared statement of Ms. Steinzor follows:]
Prepared Statement of Ms. Rena Steinzor, Professor, University of
Maryland School of Law, and President, Center for Progressive Reform
Mr. Chairman, Ranking Member Edwards, and Members of the
Subcommittee, I appreciate the opportunity to testify before you today
on one of the Environmental Protection Agency's (EPA) most important
and foundational programs, the Integrated Risk Information System
(IRIS). Let me get straight to the point. These days, the more
important a public health program, the more likely it is to be the
subject of relentless, intemperate, and unjustified attacks. IRIS is no
exception. What is in fact a sober, well-informed, and carefully
conducted scientific effort to synthesize existing research in order to
set reference doses for the most toxic chemicals is portrayed by
industry lobbyists as an anti-scientific effort to ``demonize'' such
ostensibly benign substances as arsenic, formaldehyde, and dioxin. This
deliberate misreading of the science by industry lobbyists is intended
to prolong Americans' exposure to dangerous substances in the service
of corporate profit, while at the same time immobilizing the federal
agency best qualified to protect public health, the EPA.
The truth is that everyone attending this hearing would be hard-
pressed to come up with more than a dozen examples of toxic chemicals
that have been found to be significantly less harmful than we
originally thought when additional research was done. The powerful
historic trend moves strongly in the opposite direction: as the
research has accumulated, chemicals like dioxin, arsenic, formaldehyde,
cadmium, mercury, and lead prove to be more toxic than we first
imagined. Endless efforts to deconstruct individual studies should not
obscure this trend, as the chemical industry was well aware until the
current backlash against regulation offered it new opportunities to
defeat safeguards that protect public health by distorting EPA's track
record.
IRIS started as an internal EPA database used to develop
toxicological profiles for common chemicals. These profiles set the
reference dose, or RfD, for a given chemical on the basis of existing
scientific literature. An RfD is the amount below which human exposure
is deemed unlikely to cause adverse health effects. Over time, IRIS has
become an invaluable resource: It receives some 2,000 internet visits a
day, testament to its importance as among the best, most comprehensive
databases for this kind of baseline information. And, although IRIS
itself most definitely is not a regulatory program, it provides a
strong scientific foundation for much of the rest of the agency's work.
Without the scientific determinations IRIS contains, EPA would be hard-
pressed to develop standards for the control of emissions of toxic
chemicals that cause brain damage, cardiovascular illness, reproductive
dysfunction, cancer, and a range of other diseases. Delaying the
production of IRIS profiles costs lives and endangers public health, an
intolerable outcome that this Committee must not allow to happen.
My testimony today makes four points about the future of the IRIS
program:
From the American public's perspective, the central and
urgent problem with IRIS is not that it rushes to judgment on toxic
chemicals. Far from it. The problem is that repeated rounds of
redundant ``peer review'' and interagency comment allow--in fact,
invite -chemical manufacturers, the Department of Defense, and other
self-interested parties to slow the program to a crawl. Because these
delays help to ensure that dangerous chemicals are left in commerce for
years longer than necessary, people suffer avoidable diseases and
irrevocable neurological and reproductive damage. The Government
Accountability Office (GAO) has repeatedly warned Congress about the
negative implications of these delays. See, e.g., GAO-08-6743T, EPA's
New Assessment Process Will Increase Challenges EPA Faces in Evaluating
and Regulating Chemicals (April 29, 2008) and GAO-09-271, HIGH-RISK
SERIES, An Update (January 2009). GAO has placed the EPA chemicals
program in the ``high risk'' category reserved for a small number of
the most troubled programs in government. It made this important
decision in part because IRIS updates are so slow that the data base
risks becoming obsolete. It did not make any reference to the distorted
critique of EPA science that the chemical industry has developed.
Given that IRIS is constantly struggling to avoid capture
by the chemical industry and, if anything, gives manufacturers far too
many opportunities to befuddle final assessments, the chemical
industry's sudden discovery of its flaws is as opportunistic as it is
incredible.
The National Research Council's (NRC) report on
formaldehyde does not justify the radical changes sought by the
industry. In fact, the NRC explicitly endorsed the program's
continuation and improvement. Its critique of the formaldehyde
assessment constitutes robust peer review, not an outright condemnation
of the program and EPA science as industry witnesses would have you
believe. I wish that the NRC committee had not adopted such a haughty
tone in scolding EPA staff. But that tone was the product of political
naivet regarding how its report would be exploited in the existing
political climate. It cannot fairly be characterized as a
recommendation that IRIS stop-or even slow-its critical work.
The remedies sought by the American Chemistry Council
(ACC) are designed to run IRIS off the road, further undermining EPA's
mission to protect public health. I urge the Committee to side with the
public, not the manufacturers of toxic chemicals long overdue for
assessment and control.
I am a law professor at the University of Maryland School of Law
and the President of the Center for Progressive Reform (CPR) (http://
www.progressivereform.org/). Founded in 2002, CPR is a 501(c)(3)
nonprofit research and educational organization comprising a network of
sixty scholars across the nation who are dedicated to protecting
health, safety, and the environment through analysis and commentary. I
joined academia mid-career, after seven years as an attorney at the
Federal Trade Commission, five years as staff counsel to the House
Energy and Commerce Committee, and seven years representing small and
mid-sized electric utilities. My work on environmental regulation
includes four books, and over twenty-seven articles (as author or co-
author). My most recent book, published by the University of Chicago
Press, is The People's Agents and the Battle to Protect the American
Public: Special Interests, Government, and Threats to Health, Safety,
and the Environment, which I co-authored with Professor Sidney Shapiro
of Wake Forest University's School of Law, analyzes the state of the
regulatory system that protects public health, worker and consumer
safety, and natural resources, concluding that these agencies are
under-funded, lack adequate legal authority, and are undermined by
political pressure motivated by special interests. I have served as a
consultant to EPA and have testified previously before Congress on
regulatory subjects on numerous occasions.
Saving IRIS
Since 2005, Member Scholars at the Center for Progressive Reform
(CPR) have researched and written five white papers regarding IRIS and
the need to streamline the process for developing toxicological
profiles and several letters to decision makers concerned about the
program's future. They are available here: http://
www.progressivereform.org/IRIS.cfm, and I have attached the two most
recent reports, Corrective Lenses for IRIS and Setting Priorities for
IRIS to this testimony. Our key findings include:
1. IRIS is woefully incomplete. EPA is many years behind in
completing profiles of at least 255 chemicals. Some 109 chemical
profiles that EPA was required by the Clean Air Act Amendments of 1990
to have completed by 2008 are either included in IRIS but missing
critical elements, or entirely absent from the database. A similarly
sad situation afflicts the agency's efforts to carry out the statutory
mandates of the Safe Drinking Water Act. Every five years, EPA
generates a new Contaminant Candidate List (CCL). The lists contain
recommendations both for chemicals and microbiological contaminants.
Since 1996, EPA has published three CCLs that contain 156 distinct
chemical substances. IRIS profiles are missing for 64 (41 percent) of
these substances.
2. So severe are the delays in the IRIS process that a 2008 GAO
report warned that the Bush Administration's approach to IRIS, which
resulted in just two completed profiles per year, left the database at
risk of becoming obsolete. (The report is available at http://
www.gao.gov/new.items/d08743t.pdf.) To its credit, the Obama
Administration revised the IRIS process in an effort to speed the
production of assessments, and has managed to increase the number of
completed profiles to nine annually. But although this performance is a
definite improvement, the rate of production is still slow enough that,
if nothing else is done to improve the pace of IRIS, EPA will not catch
up with its existing backlog for another 55 years.
3. One area of particular concern is that the Obama
Administration's new IRIS process left in place many of the roadblocks
GAO had previously identified, including interagency review of
individual assessments, multiple reviews by outside science panels, and
prioritization of a few high-profile assessments at the expense of
faster assessments. Potentially regulated parties, including other
federal agencies like the Department of Defense and National
Aeronautics and Space Administration, have targeted IRIS as a choke
point for regulation. The labyrinthine process they have demanded,
diagrammed on page 9 of the Corrective Lenses report, contains multiple
rounds of peer review, public comment, and interagency review that are
as redundant as they are time-consuming. In effect, the program suffers
from the problem of ``information capture''-a phenomenon where
potentially regulated industries and their federal agency clients
submit so much irrelevant data to EPA, and do so with such frequency,
that new assessments become mired in never-ending controversy.
4. To close data gaps and reestablish IRIS's credibility as a
cutting-edge database, EPA needs to make four changes. First, EPA
should reduce the procedural burdens that were formalized during the
Bush administration. Second, EPA must articulate clear, statute-driven
priorities about which assessments to complete to ensure that data gaps
in statutory mandates would be more quickly addressed. Third, the IRIS
process must be restructured to allow for timely assessments to be
written on the basis of the weight of available evidence at the time an
assessment is undertaken. Fourth, EPA must have adequate resources-and
use those resources efficiently--to complete a much larger number of
assessments.
One additional point is worth making. The chemicals we are talking
about here are the worst of the worst, produced in amounts of millions
of pounds annually. As just one example, chromium compounds, which are
categorized in the worst ten percent of all toxic chemicals and are
among the hazardous air pollutants missing from IRIS, are emitted in
amounts exceeding 58 million pounds annually. Unsafe exposure to
chromium compounds causes cancer, suppresses immune systems, and harms
kidney and respiratory functions. Over the last several years, industry
has sponsored several studies of chromium. When a study documents
adverse effects at common levels of exposure, the sponsors commission a
second study designed to rip apart the first. Unfortunately, the
victims of this endless treadmill are neither the sponsors, nor the
scientists engaged in chasing each other's tails, but rather the
public's health.
Industry Influence over IRIS
Anyone who has observed IRIS for many years cannot help but find
the chemical industry's recent denunciations of the program
disingenuous, even surreal. Far from being helpless bystanders in the
process, industry Members have been in the thick of the action since
the database was initiated, submitting the research they think most
important and repeatedly advocating their view of the research to IRIS
staff, more senior EPA officials, sympathetic federal agencies and
departments, and the White House Office of Information and Regulatory
Affairs (OIRA). To whatever extent that IRIS science is flawed, the
people complaining about those flaws are full partners in its
development. In fact, one reason why IRIS profiles have ballooned into
unmanageable length is the reaction of EPA staff to constant harassment
by industry participants.
The Formaldehyde Review
The NRC conducted a robust peer review of the draft IRIS
formaldehyde assessment. The report is written in the detailed language
of one group of scientists giving another group of scientists an
unvarnished assessment of how a scientific finding could be revised and
bolstered. Its work will undoubtedly improve the IRIS process, and EPA
is already taking its recommendations to heart.
Unfortunately, the NRC reviewers also succumbed to the fatal
attraction of reiterating their professional superiority, using tough,
even haughty language to critique EPA's work, and exhibiting a
remarkable level of insensitivity to how their comments would be
interpreted in the over-heated political atmosphere that afflicts the
nation's Capitol these days. Clearly, the NRC committee was trying to
help IRIS staff to do better, not to immobilize the program. Consider
the following direct quotes from the NRC report:
The draft IRIS assessment correctly concludes that formaldehyde
is a genotoxic (DNA-reactive) chemical that causes cytogenetic effects,
such as mutations. (emphasis added) (p. 4)
The committee recognizes that revision of the approach will
involve an extensive effort by EPA staff and others, and it is not
recommending that EPA delay the revision of the formaldehyde assessment
to implement a new approach. However, models for conducting IRIS
assessments more effectively and efficiently are available, and the
committee provides 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. (emphasis added) (p. 11)
As a person who teaches for a living, I would urge future NRC
panels to keep in mind how much self-important scolding can interfere
with a student's learning process-we all know that truth in our
academic lives but may forget it when we enter the policymaking world.
Regardless, Congress would make a grave error if, at the behest of
self-interested chemical manufacturers, it ignored the stated goals of
the NRC's review.
Excessive Remedies
The remedies proposed by the chemical industry representatives here
today confuse and distort the core purposes of IRIS. For example, one
of the most intemperate proposals advanced by the American Chemistry
Council is that the OIRA increase its oversight of the program. OIRA is
the division within the White House that checks agency cost-benefit
analyses. It is staffed almost exclusively by economists who have no
better idea of what constitutes a good RfD than any other lay person.
Two scientists work at OIRA, in comparison to the dozens of well-
qualified scientists representing multiple disciplines who work at EPA.
The recommendation that OIRA be put in charge of IRIS is not designed
to improve the program's scientific validity, but rather is intended to
give chemical manufacturers a sympathetic forum where they can tie IRIS
in knots more easily.
A second industry demand voiced by ACC is that NRC be brought in to
review all IRIS assessments. NRC is the gold standard for peer review
and, as I mentioned earlier, its critiques are always interesting. On
the other hand, the academic scientists who serve on NRC review
committees receive compensation that does not nearly pay for their
time. Instead, they are motivated by a commitment to public service,
the pleasure of engaging with bright and sophisticated colleagues, and
the prestige of serving by invitation on a panel convened by the finest
scientific institution in the nation. Using NRC to run around double-
checking government work would corrode this delicate balance,
ultimately rendering it unworkable. Not incidentally, it would also add
unreasonable delay to an already dangerously slow process. I hope that
the NRC recognizes the insidious implications of this recommendation
and strongly opposes it.
The invocation of NRC, and the National Academies as a whole, has
become a common practice for potentially regulated parties who hope to
slow down EPA decision making. The little-recognized hypocrisy of this
practice is that when NRC ratifies EPA's judgments without
qualification, aggrieved industry participants simply ignore its
findings and proceed with their campaign against the agency. So, for
example, NRC issued a report on mercury that was fully supportive of
the RfD that EPA had set for the substance. (The NRC report is
available at http://www.nap.edu/openbook.php?isbn=0309071402.) The
electric utilities fighting EPA's regulatory efforts simply ignored the
NRC report as if it had never been completed, continuing their attacks
on the research underlying the agency's decision. Far from serving as
an umpire in heated disputes, NRC was exploited as a tool to delay
final action and then promptly cast aside.
The final, penultimate example of overreaction that will endanger
public health is the rider now pending in the House Appropriations
Committee. It would bar EPA from moving forward with future assessments
until all existing assessments had been revised to conform to the NRC's
advice about the formaldehyde assessment. This proposal would paralyze
the IRIS program for the foreseeable future by forcing its staff to
engage in a massive round of paper shuffling.
In a surprisingly successful effort to obscure the real motivations
behind these radical suggestions, regulated industries have portrayed
them as essential to job creation, and therefore of direct benefit to
the average American. Fundamental to this set of claims is the notion
that regulatory excesses in these times of economic recession have hit
industry so hard that its Members cannot afford to expand their
businesses and put people back to work. But some quick research on the
percentage increase in profits from 2009 to 2010 for some of the ACC's
largest Members yielded surprising results.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Rules to protect public health and the environment most definitely
do not have the effect of sweeping money into a pile and setting it on
fire. Rather, they save the lives of millions of people, prevent many
more millions from getting sick or becoming sicker, and preserve the
irreplaceable natural resources without which human life would be
impossible.
For example, Clean Air Act regulations are uniformly recognized as
a wonderful economic bargain by honest experts from all points on the
political spectrum. According to EPA's very conservative numbers, which
dramatically understate benefits and overstate costs, clean air rules
saved 164,300 adult lives in 2010, and will save 237,000 lives annually
by 2020. EPA estimates that the economic value of Clean Air Act
regulatory controls will be $2 trillion annually by 2020; costs of
compliance in that year will be $65 billion. Air pollution controls
saved 13 million days of work loss and 3.2 million days of school loss
in 2010. By 2020, they will save 17 million work loss days and 5.4
million school loss days. I emphasize that EPA's cost estimates are
based on extraordinarily conservative assumptions regarding regulatory
benefits. For example, EPA says that a non-fatal heart attack in a
person 0-24 years old is worth only $84,000 and that an emergency room
visit to treat an asthma attack is worth only $363 per incident-
hospitals don't give you a plastic ID bracelet for that little.
And according to OIRA, which houses the staff of economists so
embraced by ACC, ``the estimated annual benefits of major federal
regulations are in the aggregate between $132 billion and $655 billion,
while the estimated annual costs are in the aggregate between $44
billion and $62 billion.'' (See http://www.whitehouse.gov/sites/
default/files/omb/inforeg/2011--cb/2011--cba--report.pdf.)
Thank you, Mr. Chairman and Ranking Member Edwards. I would be
happy to answer any questions you may have.
Attachments:
1. CPR Report, Corrective Lenses for IRIS
2. CPR Report, Setting Priorities for IRIS
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Chairman Broun. Thank you, Ms. Steinzor.
I now recognize our next witness, Dr. Charnley, for five
minutes. Dr. Charnley.
TESTIMONY OF GAIL CHARNLEY, PRINCIPAL, HEALTHRISK STRATEGIES
Dr. Charnley. Thank you, and good morning. I am a
toxicologist, a human health risk analyst, and a toxicology
consultant who has relied for many years on the information
contained in the IRIS database for my work. I am speaking on
the basis of my 30-year career as a scientist evaluating the
relationship between chemical exposures and human health
effects, and I am not representing any organization today.
The role and purpose of IRIS are good and well-intentioned,
but over the years IRIS has lost its way, straying from science
and veering towards advocacy. As a result it no longer has much
scientific credibility outside the agency or, importantly,
within the agency itself.
IRIS started out as a good idea, an advisory group of
scientists that assessed chemical toxicity for the rest of EPA.
The reach of IRIS goes way beyond EPA, however, as other
federal agencies, state and local governments, both within the
United States and in other countries, lacking their own
resources to generate toxicity values, chemical toxicity
values, have come to rely on those generated by IRIS. Because
the influence of IRIS is so broad, the scientific quality and
integrity of its reviews are critically important.
The problem is that IRIS toxicity evaluations do not follow
a rigorous, objective, transparent, scientific weight of
evidence process, instead, relying on what--in the absence of
such a process--appears to be cherry-picking data in support of
policy preferences as needed.
A true weight of evidence analysis should explicitly
present the criteria for inclusion and exclusion of studies so
that all relevant information is included and so that biases
towards the inclusion of certain outcomes are avoided.
IRIS assessments fail to use a weight of evidence process
despite the explicit direction to do so provided by EPA's own
risk assessment guidance and repeatedly by various National
Academy of Sciences committees. My written statement details
some of the large body of EPA documentation stating that it is
EPA policy to perform balanced weight of evidence analysis as
part of chemical risk assessment, a policy that is clearly
being ignored by IRIS.
I think the solution is not to try once more to tweak or
revamp the existing process but to start over. Public health is
not served by a broken, cumbersome, controversial process that
lacks a rigorous scientific foundation and a transparent,
replicable weight of evidence framework. Setting up a more
effective process should follow the recommendations of a
National Academy of Sciences committee convened for that
purpose and should follow a weight of evidence procedure
recommended by the Academy.
Chapter seven of the Academy's formaldehyde report provides
helpful but general guidance toward that end, and, no, I am not
advocating that NAS review all IRIS reviews.
EPA's recently proposed IRIS redesign relies on EPA's
Science Advisory Board for, ``independent review and
oversight,'' instead of the Academy. However, the SAB is not
independent. EPA officials select SAB Members, formulate charge
questions, provide staff support for the review process, and
oversee SAB deliberations and report drafting.
In contrast, the NAS process for selecting scientific panel
Members and conducting reviews assures independence and
objectivity along with appropriate expertise for which they are
not compensated in any way.
Truly independent peer review is the only way to give
stakeholders confidence in the credibility of the outcome.
Stakeholders are likely to accept the outcome of an independent
Academy committee and unlikely to accept the outcome of an EPA-
administered committee.
In conclusion, the IRIS process is dysfunctional and
attempts to tweak it have not resulted in meaningful
improvements. Changes proposed this week are promising, but I
believe that implementing those changes and implementing an
improved, scientifically-based, transparent IRIS process would
benefit greatly from National Academy of Science's guidance.
The NAS is in a unique position to provide unbiased, credible,
expert advise that, sadly, is so critically needed at this
point if we are to move IRIS into a 21st century approach to
assessing chemical toxicity effectively.
Thank you.
[The prepared statement of Ms. Charnley follows:]
Prepared Statement of Dr. Gail Charnley, Principal, HealthRisk
Strategies
Good morning. I am speaking today as a toxicologist with a Ph.D.
from MIT, as a human health risk analyst, and as a toxicology
consultant to private clients who has relied for many years on the
information contained in the IRIS database for my work. I am speaking
on the basis of my 30-year career studying the relationship between
chemical exposures and human health effects, as executive director of
the bipartisan Presidential/Congressional Commission on Risk Assessment
and Risk Management, as a member of the National Toxicology Program's
Report on Carcinogens Committee, as a former senior program officer in
the National Academy of Sciences' Toxicology and Risk Program, as a
member of National Academy of Sciences committees, and as a member of
the National Academy of Sciences Board on Environmental Studies and
Toxicology. I am not representing any organization today, however, or
being paid for my testimony.
The role and purpose of IRIS are good and well-intentioned, but
over the years IRIS has lost its way. IRIS started out as a good idea-a
scientific advisory group that assesses chemical toxicity for the rest
of EPA so as to avoid every office having to do it themselves and
generating potentially conflicting toxicity values. The reach of IRIS
goes far beyond EPA, however, as other federal agencies and state and
local governments in the U.S. and other countries lacking their own
resources for generating chemical toxicity values have come to rely on
those generated by IRIS. IRIS assessment can thus become a de facto
component of regulatory decision-making without benefit of appropriate
administrative process. Because the influence of IRIS is so broad, the
scientific quality and integrity of its reviews are critically
important.
Unfortunately, over time the IRIS process has become politicized
and, as a result, it no longer has much scientific credibility outside
the agency or, importantly, even within the agency. The process has
strayed from science and veered towards advocacy. As you have heard
from other speakers this morning, IRIS toxicity evaluations do not
follow a rigorous, objective, transparent, scientific weight-of-
evidence process, instead relying on cherry-picking data as needed to
support policy preferences. Indeed, many of IRIS' recent conclusions
appear to be based on what my colleagues and I refer to as ``magical
modes of action'', that is, highly speculative biological explanations
for toxicity.
IRIS assessments fail to evaluate potential human cancer and
noncancer effects of chemical exposures using a weight-of-evidence
analysis despite the direction to do so provided by EPA's own risk
assessment guidance documents and, repeatedly, by various National
Academy of Sciences committees. For example, EPA's Information Quality
Guidelines state that when EPA develops ``influential'' scientific risk
assessments, it intends to use all relevant information and reach a
position based on careful consideration of all such information, a
process typically referred to as the ``weight-of-evidence'' approach.
\2\ EPA's Assessment Factors Handbook \3\ states that a weight-of-
evidence approach generally considers all relevant information in an
integrative assessment and explains how the various types of evidence
fit together. EPA's Risk Assessment Principles & Practices
documentation asserts that risk assessment involves consideration of
the weight of evidence provided by all available scientific data. \4\
My point is that there is a large body of EPA documentation stating
that it is EPA policy to perform balanced weight-of-evidence analysis
as part of chemical risk assessment that is clearly being ignored-a
glaring omission in light of EPA's own guidelines, policies, and NAS
recommendations.
---------------------------------------------------------------------------
\1\ EPA (2002) Guidelines for Ensuring and Maximizing the Quality,
Objectivity, Utility, and Integrity of Information Disseminated by the
Environmental Protection Agency. EPA/260R-02-008. Office of
Environmental Information, Washington, DC
\3\ EPA (2003) A Summary of General Assessment Factors for
Evaluating the Quality of Scientific and Technical Information. EPA
100/B-03/001. Science Policy Council, Washington, DC
\4\ EPA (2004) Risk Assessment Principles and Practices. EPA/100/B-
04/001. Office of the Science Advisor, Washington, DC
---------------------------------------------------------------------------
A weight-of-evidence analysis for any potential health effects,
whether cancer or noncancer, should be more than a matter of describing
a set of available studies with an array of results and then announcing
one's overall subjective judgment. Because judgments made about
potential risk will usually not be definitive, it is important to
present the strengths and weaknesses of alternative judgments that
could be made, giving the reader a picture of how strongly one or
another interpretation is supported vis- . . . -vis alternative
possible explanations. Instead, IRIS assessments preclude a weight-of-
evidence analysis by selecting almost solely for studies that
demonstrate a positive result and a dose-response relationship,
typically excluding studies that demonstrate no effect and thereby
effectively preventing a balanced consideration of available evidence
supporting or refuting the biological plausibility and likelihood of
effects.
A true weight-of-evidence analysis should explicitly present the
criteria for inclusion and exclusion of studies so that all relevant
information is included and so that biases toward inclusion of certain
outcomes-such as only positive outcomes-are avoided. The goal should be
to interpret possible reasons for disagreement, not to select the
``best'' study and rely on it even if it is contradicted by other study
results. Omitting endpoints or studies that do not show a dose-response
relationship in the direction EPA favors discounts valuable
information, particularly information that could inform mode of action
as well as dose-response.
I think the solution is not to try once more to tweak or revamp the
existing process but to get rid of it entirely and start over. Public
health is not served by a broken, cumbersome, controversial process
that lacks a rigorous scientific foundation and a transparent,
replicable weight-of-evidence framework. Setting up a more effective
process should follow the recommendations of a National Academy of
Sciences committee convened for that purpose and should follow a
weight-of-evidence procedure recommended by the Academy. Chapter 7 of
the Academy's formaldehyde report provides helpful guidance to that
end. \5\
---------------------------------------------------------------------------
\5\ National Academy of Sciences/National Research Council. 2011.
Review of the Environmental Protection Agency's Draft IRIS Assessment
of Formaldehyde. National Academy Press. Washington, DC
---------------------------------------------------------------------------
Some have proposed that IRIS rely on EPA's Science Advisory Board
for independent external review and oversight instead of the Academy.
However, the SAB review process is not independent. EPA officials
select SAB Members, formulate the charge questions, provide staff
support for the review process, and observe SAB deliberations and
report drafting. According to the SAB web site, ``The Staff Office
manages EPA requests for scientific and technical advice and peer
review. The Staff Office also provides policy, technical and
administrative assistance to advisory committees in conducting meetings
and preparing reports. The SAB Staff Office oversees the formation of
advisory committees and panels . . .'' and so forth. In contrast, the
NAS process for selecting scientific panel Members and conducting
reviews assures independence and objectivity along with appropriate
expertise. Truly independent peer review is the only way to give
stakeholders confidence in the credibility of the outcome. Stakeholders
are likely to accept the outcome of an independent Academy peer review
and unlikely to accept the outcome of an EPA-administered peer review.
Then there's the problem of delay. Most of the recent controversial
IRIS assessments reviewed by the NAS had already been reviewed by the
SAB, but ended up at the Academy anyway.
In conclusion, the IRIS process is dysfunctional and attempts to
tweak it have not resulted in meaningful improvements. Developing an
improved, scientifically based, transparent IRIS process would benefit
greatly from National Academy of Sciences guidance. The NAS is in a
unique position to provide unbiased, expert advice that, sadly, is so
critically needed at this point if we are to move IRIS to a 21st
century approach to assessing chemical toxicity effectively.
Chairman Broun. Exactly five minutes. Exactly.
Mayor Bollwage, you are now recognized for five minutes.
TESTIMONY OF J. CHRISTIAN BOLLWAGE, MAYOR, CITY OF ELIZABETH,
NEW JERSEY
Mr. Bollwage. Thank you very much, Mr. Chairman and Members
of the committee. I just want to say upfront that I am a mayor.
I am not a scientist, so I talk about trying to create jobs,
economic development. We work with our city councils, our
department managers. We make decisions on the ground every day,
but risk management is one of those areas where local elected
officials must make decisions, and we always like to have the
best available tools.
The IRIS System is a mix of scientific measure, expert
guesswork, and surrounded by a high level of uncertainty with
what might happen to humans if they are exposed to chemical
substances. In the end from my position it is a tool, and we
have learned through the experience of governing city that when
you use a tool to guide decision making, you want to use the
right tool, applied to the right problem, and use the tool in
the right way. And the IRIS method has to yield the result that
makes commonsense.
I have worked closely with the Conference of Mayors for 15
years in convincing the EPA and the Congress that not all
contaminated sites in communities are the same. There are
grossly contaminated sites called Superfund, but there are
hundreds of thousands throughout our country less contaminated
brownfield sites. I am very concerned with the public health in
my community, and if that health threat can be dealt with and
brownfield sites properly redeveloped, then it is a win-win for
the community. Brownfield legislation has helped us remove that
public health threat. We put these lands back to productive use
creating jobs, urban redevelopment, new sources of revenues
that are used to support public safety, public health, and
maintain our physical infrastructure.
One of the greatest impediments to this type of progress
was the way that the EPA and the press have over-characterized
the risk to the public. This attached an unpardonable stigma to
any site whether the contamination was serious or negligible.
Generally the risk has been overplayed, and it has become
difficult from my position to educate the public about the
difference between a brownfield site and a Superfund site.
This was the case even after the EPA Administrator Browner
released over 30,000 sites that were on the CERCLIS list, and
these were not contaminated enough to warrant any further EPA
action.
I have a Superfund site in the City of Elizabeth. It is
severely contaminated and way too costly to ever clean up. I
also have brownfield sites. I am proud to report we developed
many of those, IKEA Super Center, Jersey Gardens on a 166-acre
former landfill. Has four hotels as well as 2 million square
feet of retail space. They are thriving, and they have created
hundreds of jobs, promoted redevelopment, and has been an
enormous success for our community.
I have submitted to the committee a report prepared by the
Conference of Mayors that shows brownfield redevelopment in
cities across the Nation have had the same positive impact
because of local government's decisions.
EPA's dioxin reassessment will converge with the IRIS
System, and this combination will impact a wide range of policy
decisions. The Conference of Mayors believes this tool as
applied to brownfield sites could bring back the stigma of a
Superfund site. And as a tool the IRIS System relies on
toxicity values that are established with a very wide margin of
error that is intended to allow for uncertainty.
So when the IRIS System is used to inform risk management
decisions, it must be noted that the compound effect of overly-
conservative toxicity values with overly-conservative exposure
scenarios can yield a very distorted characterization of risk.
For example, when EPA proposed to lower the dioxin soil
concentration for a contaminated site remediation, they
proposed to lower the existing guideline from one point--one
part per billion to 76 parts per trillion or even 3.7 parts per
trillion.
So not only is the exposure scenario unrealistic, but at
3.7 parts per trillion of dioxin, the soil in every urban
center in this country would pose an unacceptable risk because
background levels are normally two to four times higher than
that.
So here is what troubles the mayors. People get 95 percent
of dioxin from the foods they eat, not from a contaminated
brownfield site. EPA continues to rely on a worst-case exposure
scenario. So I have doubts about how this IRIS tool can be
applied with any certainty.
So I would like to make some following suggestions. The EPA
can continue to improve the IRIS and the information based on
toxicity and exposure assessment. The exposure assessment is
something that should be evaluated by the National Academies of
Science to determine if more realistic assumptions are
appropriate.
For example, it would be helpful to have actual
measurements of a most-likely-case scenario in addition to a
worst-case scenario.
IRIS should be a tool to advise decisions, not mandate
them. Mayors need the best tools available to help us make
sound decisions. Our goals for our cities are to protect the
public health and the environment while encouraging economic
vitality.
I want to thank you, Mr. Chairman, for this time, and thank
Members of the committee as well.
[The prepared statement of Mr. Bollwage follows:]
Prepared Statement of The Honorable J. Christian Bollwage, Mayor, City
of Elizabeth, New Jersey
My name is J. Christian Bollwage, and I am Mayor of the City of
Elizabeth, New Jersey and Chair of the Conference of Mayors Brownfields
Task Force for the past 15 years. I appreciate this opportunity to
provide comments to the House Science Committee and I thank the
Chairman for extending the invitation to participate in this panel.
I am here representing The United States Conference of Mayors which
is the non-partisan organization that represents cities with
populations of 30,000 or more through their chief elected official, the
Mayor. There are over 1,200 cities throughout the United States.
I want to emphasize that I am a Mayor, not a scientist and
therefore I am not accustomed to participating in scientific and
technical discussions. However, I was asked to come before you today to
provide comments on the real-world impacts of applying scientific
assessment tools at the community level, and this I have done since
becoming a locally-elected official.
I am certainly not an expert on the IRIS system, but for want of a
better tool, my staff are users of the IRIS system approach to hazard
and human exposure assessment.
Mayors, with their City Councils and Department Managers, have to
make decisions on the ground every day to run a city. While many of
these decisions require the careful application of common sense, some
are more complicated, and these types of decisions require the use of
more sophisticated decision-making tools.
Risk management is one of those areas where local elected officials
must make decisions, and we like to have the best tools available to
assist us with our efforts.
The IRIS system is not some sort of ``sacred tool'' that should
never be questioned or evaluated. It does seem, however, that it is
shrouded in a mix of scientific measurement, expert guesswork, and
deals with a high level of uncertainty.
I have been told that the IRIS method is one that combines
measurement precision and a lot of guesswork about what might happen in
humans if they are exposed to chemical substances. But, in the end, it
is just a tool used by decision-makers.
I have learned through the experience of governing a city for
nearly 2 decades that when you use a tool to guide decision-making, you
want the right tool, applied to the right problem. And you want to use
that tool the right way.
So, even though the IRIS method has some valid scientific
components, it still has to yield a result that makes sense, even to
the laypeople in the community.
That is what I want to comment on here today.
I worked closely with the Conference of Mayors starting 15 years
ago to convince the EPA and Congress that not all contaminated sites in
communities are the same.
There are grossly contaminated sites that are Superfund sites with
New Jersey having more than its fair share. But there are hundreds of
thousands of less contaminated sites, known as brownfields that could
be a potential public health threat but could also be cleaned up and
turned into property that contributes to the well-being of that
community. As a Mayor, the public health in my community is a paramount
consideration. I am seriously concerned about the health of our
children, our pregnant women, our average citizens and our city
employees. However, I also don't want to unnecessarily cordon off
pieces of property that should be properly evaluated, cleaned up, and
reclaimed.
That is why I worked so hard with the Conference of Mayors to get
Congress and the Administration to establish Brownfield redevelopment
policies.
Brownfield legislation has helped us remove the public health
threat, and we have put these lands back into productive use creating
jobs, urban redevelopment and new sources of revenues that are used to
support public safety, public health and maintain our physical
infrastructure.
One of the greatest impediments to this type of progress was the
way EPA and the popular press characterized contaminated land in the
1980s. EPA was, in our opinion, `less than careful' about how they
originally characterized the risk to the public. In public hearings in
many communities across the nation there was an unpardonable stigma
attached to any site with contamination whether the contamination was
serious or negligible. The popular press played an important role in
fanning the flames of fear among the public. This made it virtually
impossible to redevelop these properties. Developers wouldn't touch
them, banks wouldn't lend money, and instead we had the abandonment of
previously developed sites in favor of greenfields which contributed to
urban sprawl.
Generally, the risk was so over-played that it became a burdensome
task to educate Congress and the public about the difference between a
brownfield site and a Superfund site. This was the case even after EPA
Administrator Carol Browner released over 30,000 sites that were on the
CERCLIS list and said that these were not contaminated enough to
warrant any further EPA action.
I have a Superfund site in Elizabeth New Jersey. It is severely
contaminated, and would pose a public health problem if it were not
cordoned off properly- which it is. This site will likely plague the
city for the next century because it was determined that it will cost
too much money to clean it up.
I also have quite a few brownfield sites in Elizabeth. I am proud
to report that we have redeveloped many of them including the IKEA
Super Center and the Jersey Gardens, an economically thriving shopping
center that has created hundreds of jobs, promoted redevelopment and
has been an enormous help to the city's economy.
I am submitting to the Committee a report prepared by the
Conference of Mayors that shows that brownfield redevelopment in cities
across the nation have had the same positive impact because local
government made the decision to clean these sites up, remove the
potential public health threat and returned the land to productive use.
But once again I am in Washington on the topic of not stigmatizing
the redevelopment of brownfields unnecessarily. EPA's dioxin
reassessment will converge with the IRIS system, and this combination
will impact a wide range of policy decisions, including Preliminary
Remediation Goals (PRGs) for dioxin levels in soil. The Conference of
Mayors' believes this could have a severe impact on brownfields and
other urban and suburban development.
The U.S. Conference of Mayors is concerned that EPA's toxicity and
exposure assumptions would drive dioxin PRG values down to levels that
are below average concentrations in U.S. cities, and perhaps below
current background levels in urban and suburban soils.
As a tool, the IRIS system relies on toxicity values that
established with a very wide margin of error built in that is intended
to allow for uncertainty. The system also relies on exposure assessment
calculations that rely on substantial exaggeration on risk.
When the IRIS system is used to inform risk management decisions it
must be noted that the compound effect of overly conservative toxicity
values with overly conservative exposure scenarios yield a very
distorted characterization of risk.
This type of calibration of the different parts of the tool leaves
local decision-makers with a risk analysis that is not realistic.
For example, when EPA proposed to lower the dioxin soil
concentrations for contaminated site remediation they intended to lower
the existing guideline from 1 part per billion to 76 parts per trillion
or even 3.7 parts per trillion. These lower standards were based on
EPA's overly conservative approach to estimating dioxin toxicity in
combination with assumptions about exposed children wallowing in the
contaminated site soils.
Not only is the exposure scenario unrealistic, but at 3.7 parts per
trillion of dioxin, the soil in every urban and suburban area would
pose an unacceptable risk because background levels are normally two to
four times higher than 3.7 parts per trillion.
Even lowering the dioxin standard in soil to 76 parts per trillion
is lowering the so-called danger point to where the public will
question their safety.
What is troubling about those proposals for a Mayor is two
important facts:
1. All of our citizens are getting 95 percent of their dioxin from
the foods they eat, not from a contaminated brownfield site, and,
2. Rather than rely on worst-case exposure scenarios, the
University of Michigan published a study that looks at actual dioxin
levels in people reports:
People who live on contaminated soil and have
contaminated household dust do not have higher levels of dioxins in
their blood. A study involving direct human measurement included 21
people who lived on soil contaminated at 1,000 to 11,200 ppt TEQ of
dioxins.
The study authors stated that they believe their
results apply to populations whose soil is contaminated in this range.
EPA exposure assumptions are predominantly determined by policy
judgments that are so overwhelmingly reliant on worst-case scenarios
that they do not at all reflect the realities of potential human
exposure
So, I have doubts about how this IRIS tool can be applied with any
certainty. And I am very concerned that it is the wrong tool for making
local decisions.
Our August 2010 Policy Paper highlights that these dioxin standards
``at or below background levels and if implemented will have an
immediate chilling effect on the successes achieved over the last two
decades to clean-up [brownfields] sites and return these properties to
productive use.''
So using this tool with its distortion of risk does not pass the
reasonable-sense test at the local level.
On the other hand, I understand the need for the EPA to develop
assessment tools to help local decision-makers, so I would like to make
the following suggestions.
1. The EPA should continue to improve IRIS and the information
base on toxicity and exposure assessment
2. The exposure assessment assumptions should be evaluated by the
National Academies of Science
I think we are too smart in today's world to rely on
one-size-fits-all assumptions in risk management when the stakes are so
high
Instead of EPA focusing on ``worst case scenarios'',
they should also look at the ``most likely case''. This would be more
useful to decision-makers to better understand the true risk of their
decisions.
3. The EPA should not force local officials to rely on the IRIS
system to make local decisions until the Agency improves the toxicity
and exposure assessment methods to better reflect reality
In particular, EPA should not force state regulators
to base brownfield site clean-up decisions on the IRIS system
Mayors need the best tools available to help us make sound
decisions. Our goals for our cities are to protect the public health
and the environment while encouraging the economic vitality. We need
tools that are based in reality and common sense.
I want to thank the Chairman and this Committee for the opportunity
to give a Mayor's perspective on this important issue.
Chairman Broun. Thank you, Mr. Mayor. I thank you all for
your testimony today.
Reminding Members that committee rules limit questioning to
five minutes. The chair will at this point open the round of
questions.
The chair recognizes himself for five minutes.
Dr. Charnley, to your knowledge does the IRIS Program
reflect the framework outlined in the report, ``Risk Assessment
and Risk Management in Regulatory Decision Making,'' developed
by the Presidential Congressional Commission on risk assessment
and risk management?
Can you briefly outline the key aspects of the framework
that should be reflected in IRIS risk assessments, and what
does it mean to understand the context of a risk problem as
discussed in the framework?
Dr. Charnley. Well, what the risk commission framework does
is emphasizes the importance of figuring out what the problem
is you are trying to address before you address it, to clarify
what your risk management goals are, and use those as a guide
to risk assessment. As Dr. Anastas pointed out, however, the
IRIS Program does not perform risk assessments. It generates
safety values. It generates toxicity values that then a risk
assessment would take, would use and compare to exposure values
to come up with some understanding of what a human health risk
might actually be.
So what the IRIS Program does is provide some of the
information that could be used in risk management but doesn't,
it doesn't have the same context.
Chairman Broun. Okay. Congressman Dooley, 2 days ago Dr.
Anastas participated in a press conference and offered some
insight on a new and improved IRIS process that will allegedly
incorporate the Academy's recommendations from April, while
building upon the 2009 revisions proffered by Administrator
Jackson.
Can you comment on the Agency's announcement?
Mr. Dooley. Yes.
Chairman Broun. Congressman, press the button so we can
hear you, please, sir.
Mr. Dooley. Yeah. We commend the EPA and Dr. Anastas on
some of their recent actions. I think that whatever stakeholder
you might be here, whether you are a member of Congress, a
mayor, whether you are representing consumer interest groups or
environmental groups or if you are part of the industry, we
want to have an IRIS Process that meets a gold standard. We
heard Dr. Samet say today that he would barely give it a
passing grade on the formaldehyde IRIS assessment. I don't
think any of us think that that is adequate.
And so what we have been suggesting is that we are looking
forward to the reforms that EPA is administering or enacting
now to improve their program. I think we would all have a
greater confidence that they were getting it right if for the
next period of time that the next IRIS assessments that are
coming out under these new reforms, that we would submit them
to NAS just to make sure that we would have a double check on
it to understand: did they enact the best processes, to ensure
that we are using the best scientific process, that standards
that ensure that the weight of evidence on the scientific
research was adequate, that we had a peer review process that
provided appropriate levels of transparency and independence.
That is what we are suggesting when the industry, as we
were characterized, is asking for NAS to play a major role in
reviewing the IRIS assessments that could be issued in the next
few months under the new and improved guidelines. We would all
benefit and have greater confidence if we had NAS, you know,
taking a review, making sure they got it right.
Chairman Broun. Thank you, Congressman.
Mayor Bollwage, I have got 1 minute left, so please answer
quickly. Can you give us an idea of what sort of actions that
you would need to consider as mayor if EPA proceeds with its
proposed dioxin PRG, which as you note is at or below
background levels, and what would it mean to your city, your
constituents, your economy, your jobs, et cetera? What would be
the positive outcomes of such a low dioxin PRG? That is, how
would it affect safety?
Mr. Bollwage. Thank you. Mr. Chairman, I can only explain
it real quickly with we had an outdated plastics facility, and
we wanted to convert it to Little League fields. We scraped
away 3 inches of dirt and we mediated that and converted it
into two healthy Little League fields.
If the levels are lowered, we are going to wind up scraping
away, what, 8 inches, 10 inches, 12 inches, a lot more of the
dirt in order to make that area safe for Little League.
You make the cost of a municipality increase substantially,
and I don't know of any kids who are rolling around in the
brownfields who have caught dioxin.
Chairman Broun. My time has expired.
Now I recognize Ms. Edwards for five minutes.
Ms. Edwards. Thank you, Mr. Chairman, and thank you to our
witnesses today.
I just want to start out by noting that I do share Mr.
Rohrabacher's view that it is important for us to know who is
before us and who is influencing a process but merely working
in an industry or working at an organization that advocates for
a certain position is not a reason to exclude either that
testimony or information.
Nonetheless, I think it is also important that we have the
same kind of transparency and accountability that we are
demanding of the EPA and other agencies and their process is
the same kind of transparency and accountability that we want
in those who seek to influence or advocate in the process
because it could otherwise operate to the detriment of the
public health.
Dr. Charnley, I have looked at your resume. It is very
impressive, and I note that you are currently serving on the
National Academy of Sciences Board of Environmental Science and
Toxicology. Your appointment began in 2009. Is that correct?
Dr. Charnley. Yes.
Ms. Edwards. Thank you, and when you joined the--I also
note in your testimony you indicated that you participated on
numerous peer review panels convened by the EPA. You say that
in your participation you acted independently. Isn't that
correct?
Dr. Charnley. Correct.
Ms. Edwards. Thank you, and when you joined the National
Academy of Science Board on Environmental Science and
Toxicology, we have been told that you would occasionally maybe
once or some number of times recuse yourself from board
discussions of formaldehyde. Is that right?
Dr. Charnley. That is correct.
Ms. Edwards. And why did you feel a need to or were you
required to recuse yourself, and in addition, who was paying
you at the time, and what were you being paid to do that
required your recusal?
Dr. Charnley. Nobody was paying me at the time but before I
joined the board I had given some advice to the Formaldehyde
Council on how the National Academy of Sciences process works,
and so when I served on the board, although the Academy does
not believe that previous employment counts as a conflict, I
felt that from an optics point of view, from a perception point
of view that it would make sense to recuse myself from any
discussions on formaldehyde just so that----
Ms. Edwards. Thank you.
Dr. Charnley. Yeah.
Ms. Edwards. Well, let us not talk about optics. Let me
just ask were you specifically in your--previous to your--prior
to your appointment, were you paid to advise the Formaldehyde
Council about ways in which they could use the NAS process to,
you know, to thwart the assessment process through IRIS?
Dr. Charnley. Of course not.
Ms. Edwards. And so I am just curious, were you paid by
them to advise you on how to get an Academy study on the EPA's
IRIS draft assessment for formaldehyde?
Dr. Charnley. I was not.
Ms. Edwards. Okay. So what we will do is perhaps ask you
some questions, specific questions on the record and also the
Academy about the recusal process and about your work for the
Formaldehyde Council and whether that had any impact on its
work.
Mr. Dooley, when we go to the Formaldehyde Council's
webpage right now, and I have it, we are directed to a page
that has the ACC logo on it. And then both organizations are
shown to reside at the same address in Arlington, Virginia.
What do you say about that?
Mr. Dooley. The Formaldehyde Council, just earlier this
year, I guess about 6 months ago, moved from being an
independent agency to become one of among 50 different specific
product panels that we have under ACC. So they are a self-
funded group that is operated under the umbrella of the
American Chemistry Council.
Ms. Edwards. So I am--maybe I am confused, but--so what we
have here today is we have an organization that has taken on
the work of the Formaldehyde Council, an expert who advised the
Formaldehyde Council, in my view, I think, to just use its
power to get the NAS study started. And then we are also aware,
I know I am, that Dr. Anastas's appointment was held up in the
Senate by Senator Vitter until EPA would agree to fund the NAS
formaldehyde review. And then we have one of the people who was
advising the Formaldehyde Council on how to get a report
requested of the Academy, I believe, and that report is now
being misused to excuse or cripple EPA's assessment process.
And so, as far as I am aware, none of that is--and--or
those relationships have been disclosed to the committee, but
it certainly puts your testimony in an informative light. Thank
you very much, and I yield.
Chairman Broun. Thank you, Ms. Edwards. The Chairman now
recognizes Dr. Benishek for five minutes.
Dr. Benishek. Thank you, Mr. Chairman. I find this all kind
of scary because we have limited resources to deal with these
risks, and when you hear conflicting testimony as to the
accuracy and broadness of the investigation concerning a
chemical risk, you want to spend your resources toward the
chemical that has the most risk. And to not have that risk be
politicized so you are wasting your resources on something that
is not where you should be spending your resources.
Dr. Charnley, do you have these same concerns that I do
about this process? I am concerned about the Scientific
Advisory Board for the EPA being open and not being biased. I
find in different areas of the EPA the Scientific Advisory
Boards don't have the experts on the panel that they should
have, that have enough knowledge of the thing that they are
actually judging the scientific validity of the people there,
and not the experts in the field. Do you have any information
about that that you can relate to us here?
Dr. Charnley. Well, I think that is probably correct. I
think that the difference with the Academy process is that a
committee is convened of scientists to specifically address the
substance or subject under consideration so that their
expertise does directly inform whatever the subject matter is.
And I do agree with you that putting resources towards
substances that do not pose big public health impacts directs
us away from issues and substances that do, and I don't think
that is appropriate.
Dr. Benishek. I so much agree with you. Mr. Dooley, let me
ask you a question. Do you think that the people in the
formaldehyde business want trouble with formaldehyde?
Mr. Dooley. No, absolutely not. I mean--but this, again,
comes to the essence of what this hearing is all about, how do
we establish an IRIS assessment process that has the confidence
of the NGO community or industry, that we are ensuring that it
is using the best science and the best scientific process? When
the NAS reviewed the IRIS review of formaldehyde, they found it
was significantly flawed. That doesn't serve anyone's purpose.
Formaldehyde is a building block chemical. But, even this
IRIS assessment, it has consequences. The EPA was proposing
there was an assessment level for formaldehyde, in terms of
where it could be a concern for cancer, that they set a
reference dose level that was .008 parts per billion. That was
the level that they said consumers should be concerned about a
risk of exposure. The World Health Organization had also done
an assessment and concluded that the average person's breath
contains up to 8 parts per billion. So, you back up and you
say, is this IRIS risk assessment providing information that is
really informing public health concerns, when by their own
action level--or reference is 1,000 times greater than the
formaldehyde in the air that we exhale.
And that is where we think that we have got to step back
and understand is how are we going to establish an IRIS process
that is assessing--or considering hazard and exposure to some
degree that actually can provide information that allows them
there to make the responsible decision, that allows State
regulators also to impose actions, and informs other Federal
regulatory actions that emanate from this IRIS risk assessment.
It needs to be done right. And what we are suggesting is until
we have the confidence that it is right, we ought to allow NAS
to review the IRIS assessment. And hopefully the reforms that
Dr. Anastas spoke about this week will give us that positive
outcome.
Dr. Benishek. Appreciate it. I yield back my time. Thank
you.
Acting Chairman Bushon. I recognize the gentleman from
North Carolina, Mr. Miller.
Mr. Miller. Thank you, Mr. Chairman. My questions are
similar to Ms. Edwards. Dr. Charnley, you testified that you
were not testifying on behalf of anyone. Your disclosure
statement says simply that you are not testifying on behalf of
anyone. I assume that means nobody is paying you for sitting
here today. I haven't asked you a question yet. But our
research that our staff did shows that you have, in the past,
worked for the Tobacco Institute, Phillip-Morris, Covenant and
Burling, a law firm that presumably--representing industry,
Chlorine Chemical Council, which is part of the American
Chemistry Council, American Chemistry Council, Crop Life
America, which is a pesticide manufacturer, Food Industry
Dioxin Working Group, coal companies, and then a long list of
groups that are funded by those industry groups. You have
written papers or testified about perchlorate, dioxin, mercury.
You have produced papers and editorial correspondence to
learned journals, challenging the idea that children should get
any extra measure of protection in regulatory science.
You spoke of optics. Do you think the optics here would not
have required that you tell the--this committee some of your--
the work that you have done for industry?
Dr. Charnley. Well, I think I stated clearly that I am a
toxicology consultant. In my written testimony I state that
work for--I consult to private entities, and it is, you know,
you found who I work for, so, I mean, I--it is not like--that I
am not disclosing that. I would be happy to--I have a list here
of a lot of the organizations that I have worked for, and I
will----
Mr. Miller. Could you provide that to the----
Dr. Charnley. Absolutely.
Mr. Miller. --and could you also provide the issues that
you have worked for on them?
Dr. Charnley. Sure.
Mr. Miller. Worked on them for them.
Dr. Charnley. I would be happy to.
Mr. Miller. Okay. That would----
Dr. Charnley. Most of the work I do is pro bono, by the
way.
Mr. Miller. Pro bono?
Dr. Charnley. Yes.
Mr. Miller. Okay. Well, we--actually, our able committee
staff also found an invoice that you had done a couple years
ago that showed your billing rate was $325 an hour. So you do--
also do some work for pay?
Dr. Charnley. I do. I do----
Mr. Miller. Okay.
Dr. Charnley. --both.
Mr. Miller. Okay. You spoke earlier of recusing yourself
from a peer review panel when formaldehyde came up, which is
admirable. I applaud that. If you have got an apparent
conflict, then you should recuse yourself. But was that before
or after you wrote a letter to--what is the name of the--the
Health--Environmental Health Perspectives, that did not
disclose that your--the research that you referred to in the
letter was funded by the chlorine industry?
Dr. Charnley. I have never failed to disclose the source of
my funding in anything I have published.
Mr. Miller. Okay. Did you write a letter to the
Environmental Health Perspectives?
Dr. Charnley. Yes.
Mr. Miller. Did it have to do with chlorine?
Dr. Charnley. I don't remember which one you are referring
to, I am sorry----
Mr. Miller. Okay. Do you----
Dr. Charnley. --at the moment.
Mr. Miller. You don't----
Dr. Charnley. But I----
Mr. Miller. You don't recall a controversy in which--
Environmental Health Perspectives I assume is a learned
journal? A peer reviewed learned journal?
Dr. Charnley. It is a peer reviewed journal, yes.
Mr. Miller. Okay. You don't recall that they changed their
disclosure requirements as a result of a controversy about a
letter that you wrote?
Dr. Charnley. No. I recall that I said to the editor that I
did not believe that I had a conflict because I no longer
worked for the organization that had funded this similar work
earlier. And according to the National Academy of Science's
definition of conflict, which would apply to current
employment, I did not have a conflict. However, I voluntarily
disclosed that I had worked for such an entity in the past.
Mr. Miller. Okay. It sounds like this whole issue is coming
back to you now.
Dr. Charnley. No--well, go ahead.
Mr. Miller. Sorry. No, that is all right, I--Mr. Chairman,
I have no further questions, but this remains a frustration in
witnesses before this committee, who simply fill out this--and
I had a discussion in the committee when our rules were adopted
that substantially limited the disclosure statement--disclosure
requirements, in which I was assured that if a witness had
substantial economic interests, those would be disclosed. And
we have seen repeatedly witnesses appear before this committee
and appear and testify simply as public-spirited, disinterested
citizens, and it appears their entire livelihood has come from
the industry whose interests are at stake in the committee
hearing. I would certainly hope that we could do better in the
future.
Acting Chairman Bushon. Thank you. I will take that up with
the full committee Chairman. Thanks for your comments. I will
now recognize myself for some questions, and assure the panel
that I won't spend my entire time trying to defame all of your
character.
First I want to make a few brief comments about the--what I
am hearing today. As a new member of Congress, I think the
American people, if they were hearing this hearing today about
EPA, and about the assessment they are making on chemicals, the
American people would feel they are not getting a good bang for
their buck. Just remind everyone that the budget of the EPA in
2008 was $7.6 billion. The budget was 10.3 billion in 2010.
And, believe it or not, the EPA received $7.2 billion in
stimulus money, and yet we are at a hearing today discussing
the fact that we have the inability to properly assess
chemicals at the EPA, and that is not my opinion. Let me read
from--the GAO testified before the Subcommittee that--in 2009
that EPA has not been able to complete timely credible chemical
assessments or decrease its backlog of 70, as of 2008, ongoing
assessments, even though they received 7--well, I think 7--
around 7.2 billion in stimulus money.
And it says further, because the EPA staff time was
dedicated to completing assessments in the backlog, EPA's
ability to both keep the more than 540 existing assessments up
to date and initiate new assessments was limited. So I think,
from my perspective, this calls into question a lot of the
rules that the EPA is currently putting out across the economic
spectrum that is hurting our economy. And it is becoming pretty
clear to me we don't have solid scientific evidence to back
that up. So what I want to do is direct my questions, first to
Congressman Dooley, about a couple of areas. Do you see that
the assessment ability of IRIS, as being adequate? And I think
you have stated before that you don't think it is. And based on
that, do you see that there are longstanding economic impacts
of their decision-making process, based on this information,
that is hurting our job creation in our country?
Mr. Dooley. First off is that the American Chemistry
Council is very supportive of the suggestions that the NAS made
to EPA for reforms. You know, we are encouraged that the EPA
has indicated that they are going to try to enact some of those
reforms. It is not mutually exclusive to have an IRIS risk
assessment that is being operated in a manner that is
consistent with what NAS has recommended and be a more
efficient, and result in quicker IRIS assessments being done.
And there shouldn't be any disagreement among any of us on that
issue.
When I was in Congress, I represented a district in the
central valley of California. It was the fifth lowest per
capita GDP district in the nation, out of 435. And the actions
that IRIS could take to establish reference doses that are
below those that pose any public health safety impact at
expected levels of exposure, whether it is formaldehyde or
dioxin, or whether it is arsenic, and that goes below what are
background levels existing naturally, is that that has not only
public health impacts, but it has public welfare impacts.
If you require a lot of the low income communities in my
district to comply with what is now a new arsenic standard that
goes below what is naturally occurring, is that they have to
allocate resources to water treatment systems that then aren't
available for public health or education or, other public
benefits, just as I said with dioxin. It also has an impact on
private sector investments. If we have to divert revenues to
achieve a higher level of remediation, or change processes that
go to achieve an IRIS assessment that is below background
levels, you are taking capital that could otherwise be invested
in a new manufacturing capacity, creating jobs, that is going
for a use that has very little benefit, and very little public
health benefit.
Acting Chairman Bushon. I think the answer is yes, it is
having a significant impact, and at this time I will yield the
rest of my time. And recognize the gentleman from Michigan, Mr.
Clarke.
Mr. Clarke. Thank you, Mr. Chair. In addition to IRIS,
which is located in the EPA, there are other programs that
conduct assessments of chemical risks that are located in other
agencies and departments. And this question's to anyone here.
To what degree have these assessments provided conflicting
guidance or conclusions, and to what degree have these
different programs provided--really been duplicating work? And
if you found any conflicts or duplication, what proposals do
you have to better coordinate and reduce the likelihood of
conflicts and reduce the cause of duplication?
Ms. Steinzor. If I could respond to that? IRIS is the
premiere international source of reference dose information,
which is the level below which exposure is acceptable and above
which exposure is not acceptable. So it really measures
whether--if we fed you dioxin on a spoon, what the level would
be that would cause problems. As has been said repeatedly here,
it is not a risk assessment process. It doesn't make a
determination. IRIS itself is a scientific database that
doesn't make a determination about what to do about the risk.
It simply talks about what the reference dose is. It receives
2,000 visits a day on the Internet from all over the world.
That is a pretty high number for a database that is this
technical. And, if anything, it needs to be bigger, better and
stronger, not abolished, not paralyzed, because without it
people would really not know what a toxicological profile--what
the reference dose was for chemicals. So it really is unique,
and it provides a tremendous service, I would say.
Mr. Dooley. Maybe, as Ms. Steinzor mentioned, the IRIS
reference dose is a standard which is not acceptable. And so I
go back, and I will use the formaldehyde example, where you had
the World Health Organization said the breath that you exhale
has eight parts per billion. IRIS said a reference dose of
.0008 parts per billion. You can also use the example of
arsenic, where you have a little bit of a difference in
standards internally, where you had an IRIS a risk assessment
level of 1.4 parts per billion. But then you also have, in the
safe drinking water standard, 10 parts per billion for drinking
water. So there is some inconsistencies among various
organizations there.
So I think that is where we made a suggestion from ACC that
there ought to be a role for OMB to play in this whole re-
evaluation of the risk assessment. And what we are driving at
here is because you have got multiple agencies--you have got
FDA that is involved with some chemicals, whether it is food
contact notification or assisting it, you have the Agency For
Toxic Substance And Disease Registry, you have the National
Toxicology Program, that does the report on carcinogens, you
have EPA and IRIS--is that there needs to be a quarterback.
That someone should not make determinations and evaluate
necessarily the risk assessment, but that there is a common
scientific process being utilized that is ensuring that we are
incorporating the best laboratory practices, and that we are
using the best weight of evidence practices, to reach
conclusions. And that ought to be consistent across all these
multiple agencies. And that is where we suggest that there is
an appropriate role for OMB to play, to ensure that you have
that consistency so that you don't have disparity and
conclusions in action levels across various organizations that
are maybe addressing the same chemical.
Ms. Steinzor. Can I just add one point? My son, who is 20,
is sitting behind me, and one of the most distressing things I
have heard today is that he had formaldehyde in his body and
exhales it at levels that are much higher than the reference
dose set by the EPA database. That didn't happen because he is
walking through a natural paradise on the Chesapeake Bay,
although I wish that were true. It is because the air is
polluted. We live in a non-attainment area that is awash in
toxics and all sorts of other problems, and that is why that
has happened. I also want to just say for the record there are
two scientists, two, who work at OIRA. So making them the
quarterback of anything would be a strange football game
indeed.
Acting Chairman Bushon. The gentleman's time has----
Mr. Clarke. If I can just respond to the formaldehyde?
Acting Chairman Bushon. The gentleman's time has expired.
We will get--we will try to get back to you.
Mr. Clarke. Thanks.
Acting Chairman Bushon. I would like to recognize the
gentleman from Maryland, Mr. Sarbanes.
Mr. Sarbanes. Thank you, Mr. Chairman. Thank the panel.
Congressman Dooley, I wanted to--you said a lot of nice things
about the National Academy of Sciences, and I guess that is the
basis for your proposal that they come in and review the risk
assessments that IRIS is performing for some period of time.
And you have also responded positively to changes that the EPA
has said they are going to make in response to the National
Academy of Science recommendations and so forth. On that basis,
I assume you have pretty good feelings about this silver book,
because that is a product of the National Academy of Science on
the very topic that we are discussing here today, so I wanted
to get your reactions to whether this is a constructive
resource.
Mr. Dooley. We think it is a very constructive resource. It
is not that we agree with every element in it, but we think
that it really does set a road map that has a lot that we can
all learn from and incorporate into our government processes of
assessing safety of chemicals.
Mr. Sarbanes. I haven't read it from front to back.
Actually, I have just read the back, as you may have seen. But
from what I understand, I am assuming it is proposing
recommendations that would allow the EPA and IRIS to operate in
a way that would not require a kind of constant follow up
assessment by NAS with respect to each specific chemical or
toxic substance that was being assessed. And I am nervous about
your recommendation on that, because I am worried that you are
proposing adding more steps into a process, with the potential
to kind of just drag the whole thing down and further
contribute to the delay that is so frustrating for so many
people, particularly when it comes to the issue of the worst of
the worst.
I mean, I keep hearing this phrase, I heard it in the other
committee I served on in the last term, when we were looking at
the Toxic Substances Control Act. I think, actually, you
testified--some of those hearings. The worst, the worst. We
can't seem to get even the worst of the worst--the place where
we don't have to fear those substances anymore. And a lot of it
has to do with this kind of, well, we need another study. We
need to get the OMB in here as a quarterback, you know, OIRA
and so forth and so on. We need to get moving on this stuff.
And I think what this is attempting to do is propose how you
can get the process and the framework that EPA uses to a place
where it is working pretty well, and I am worried about that
sort of getting off track.
And then, Dr. Charnley, in the time I had, you had talked
about your own view, that the changes proposed this week are
promising ones, and I think has--have also said that you regard
the National Academy of Science recommendations as helpful and
constructive. I don't see how that jives with your suggestion
that we should ``start over'' with the process that we
currently have. I think that would be a mistake. Maybe you can
clarify how you reconcile those two perspectives.
Dr. Charnley. Sure. I did not mean stop IRIS. I did not
mean disband IRIS. I meant that past efforts to modify the
process have not produced meaningful improvements, apparently,
because the Academy keeps coming back and making the same
recommendations they have made for years. And for that reason I
think that, in order to implement the changes recommended in
Chapter 7 of the formaldehyde report, that implementation would
itself benefit from guidance from the National Academy of
Sciences, from a group of unbiased experts who can--who have
been thinking about this problem for a long time and can
provide helpful guidance.
Mr. Sarbanes. Well, I think--thank you. I think that
guidance is there. I think it is constructive, and I think the
EPA is ready to move forward and keep this process of improving
on a, you know, on a positive track. Let us not get off that
track. Let us keep this process moving. With that, I yield
back, Mr. Chairman.
Acting Chairman Bushon. Thank you. At this point I would
like to ask unanimous consent to add a number of documents to
the record that have already been shared with the minority, and
I understand they wish to add the records as well. Hearing no
objection, so ordered.
[The information appears in Appendix II:]
Acting Chairman Bushon. I would like to thank the witnesses
for their valuable testimony and the Members for their
questions. The Members of the Subcommittee may have additional
questions for the witnesses, and we will ask you to respond to
those in writing. The record will remain open for two weeks for
additional comments from Members. The witnesses are excused,
and the hearing is now adjourned.
[Whereupon, at 12:24 p.m., the Subcommittee was adjourned.]
Appendix I:
----------
Answers to Post-Hearing Questions
Answers to Post-Hearing Questions
Responses by The Honorable Paul Anastas, Assistant Administrator,
Office of Research and Development, U.S. Environmental Protection
Agency
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Responses by Mr. David Trimble, Director, Natural Resources and
Environment,
U.S. Government Accountability Office
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Responses by Dr. Jonathan M. Samet, MD, MS, Professor and Flora L.
Thornton
Chair, Department of Preventive Medicine, Keck School of Medicine,
University of
Southern California; and Chair, Committee to Review EPA's Draft IRIS
Assessment of Formaldehyde, National Research Council, The National
Academies
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Responses by The Honorable Calvin Dooley, President and Chief Executive
Officer,
American Chemistry Council
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Responses by Dr. Gail Charnley, Principal, HealthRisk Strategies
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Responses by The Honorable J. Christian Bollwage,
Mayor, City of Elizabeth, New Jersey
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Appendix II
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Additional Materials Submitted for the Record
Material Submitted by Representative Larry Bucshon
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]