[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

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              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

                              ----------                              


                        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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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)
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \5\ Maria Hegstad, ``NAS Sets Back EPA Proposal For Strict 
Formaldehyde Risk Assessment,'' Environmental NewsStand, April 8, 2011
    \6\ Ibid.
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
report.

     NAS: ``Science and Decisions: Advancing Risk Assessment'' \8\
---------------------------------------------------------------------------
    \8\ ``Science and Decisions: Advancing Risk Assessment,'' National 
Research Council of the National Academies, 2009
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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:
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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)

---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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, 
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \20\ Jim Solyst, 11Eyeballing IRIS,'' The Environmental Forum, 
March/April 2009, Vol 26, No. 2

---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
    \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

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    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

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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

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Responses by The Honorable Calvin Dooley, President and Chief Executive 
        Officer,
American Chemistry Council

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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


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