[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]





                       STATUS OF REFORMS TO EPA'S
                   INTEGRATED RISK INFORMATION SYSTEM

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

                             JOINT HEARING

                               BEFORE THE

                      SUBCOMMITTEE ON OVERSIGHT &
                      SUBCOMMITTEE ON ENVIRONMENT

              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                               __________

                             JULY 16, 2014

                               __________

                           Serial No. 113-86

                               __________

 Printed for the use of the Committee on Science, Space, and Technology

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              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

                   HON. LAMAR S. SMITH, Texas, Chair
DANA ROHRABACHER, California         EDDIE BERNICE JOHNSON, Texas
RALPH M. HALL, Texas                 ZOE LOFGREN, California
F. JAMES SENSENBRENNER, JR.,         DANIEL LIPINSKI, Illinois
    Wisconsin                        DONNA F. EDWARDS, Maryland
FRANK D. LUCAS, Oklahoma             FREDERICA S. WILSON, Florida
RANDY NEUGEBAUER, Texas              SUZANNE BONAMICI, Oregon
MICHAEL T. McCAUL, Texas             ERIC SWALWELL, California
PAUL C. BROUN, Georgia               DAN MAFFEI, New York
STEVEN M. PALAZZO, Mississippi       ALAN GRAYSON, Florida
MO BROOKS, Alabama                   JOSEPH KENNEDY III, Massachusetts
RANDY HULTGREN, Illinois             SCOTT PETERS, California
LARRY BUCSHON, Indiana               DEREK KILMER, Washington
STEVE STOCKMAN, Texas                AMI BERA, California
BILL POSEY, Florida                  ELIZABETH ESTY, Connecticut
CYNTHIA LUMMIS, Wyoming              MARC VEASEY, Texas
DAVID SCHWEIKERT, Arizona            JULIA BROWNLEY, California
THOMAS MASSIE, Kentucky              ROBIN KELLY, Illinois
KEVIN CRAMER, North Dakota           KATHERINE CLARK, Massachusetts
JIM BRIDENSTINE, Oklahoma
RANDY WEBER, Texas
CHRIS COLLINS, New York
BILL JOHNSON, Ohio
                                 ------                                

                       Subcommittee on Oversight

                   HON. PAUL C. BROUN, Georgia, Chair
F. JAMES SENSENBRENNER, JR.,         DAN MAFFEI, New York
    Wisconsin                        ERIC SWALWELL, California
BILL POSEY, Florida                  SCOTT PETERS, California
KEVIN CRAMER, North Dakota           EDDIE BERNICE JOHNSON, Texas
BILL JOHNSON, Ohio
LAMAR S. SMITH, Texas
                                 ------                                

                      Subcommittee on Environment

                 HON. DAVID SCHWEIKERT, Arizona, Chair
JIM BRIDENSTINE, Oklahoma            SUZANNE BONAMICI, Oregon
F. JAMES SENSENBRENNER, JR.,         JULIA BROWNLEY, California
    Wisconsin                        DONNA F. EDWARDS, Maryland
DANA ROHRABACHER, California         ALAN GRAYSON, Florida
RANDY NEUGEBAUER, Texas              KATHERINE CLARK, Massachusetts
PAUL C. BROUN, Georgia               EDDIE BERNICE JOHNSON, Texas
RANDY WEBER, Texas
LAMAR S. SMITH, Texas



















                            C O N T E N T S

                             July 16, 2014

                                                                   Page
Witness List.....................................................     2

Hearing Charter..................................................     3

                           Opening Statements

Statement by Representative Paul C. Broun, Chairman, Subcommittee 
  on Oversight, Committee on Science, Space, and Technology, U.S. 
  House of Representatives.......................................     9
    Written Statement............................................    10

Statement by Representative Suzanne Bonamici, Ranking Minority 
  Member, Subcommittee on Environment, Committee on Science, 
  Space, and Technology, U.S. House of Representatives...........    11
    Written Statement............................................    13

Statement by Representative David Schweikert, Chairman, 
  Subcommittee on Environment, Committee on Science, Space, and 
  Technology, U.S. House of Representatives......................    14
    Written Statement............................................    14

                               Witnesses:

Dr. David Dorman, Member, Committee to Review EPA's IRIS Process, 
  National Research Council
    Oral Statement...............................................    16
    Submitted Biography..........................................    18

Dr. Kenneth Olden, Director, National Center for Environmental 
  Assessment, U.S. Environmental Protection Agency
    Oral Statement...............................................    28
    Written Statement............................................    30

Ms. Rena Steinzor, Professor of Law, University of Maryland; 
  President, Center for Progressive Reform
    Oral Statement...............................................    39
    Written Statement............................................    41

Mr. Michael P. Walls, Vice President of Regulatory and Technical 
  Affairs, American Chemistry Council
    Oral Statement...............................................    75
    Written Statement............................................    77

Discussion.......................................................    87

             Appendix I: Answers to Post-Hearing Questions

Dr. David Dorman, Member, Committee to Review EPA's IRIS Process, 
  National Research Council......................................    96

Dr. Kenneth Olden, Director, National Center for Environmental 
  Assessment, U.S. Environmental Protection Agency...............   100

Ms. Rena Steinzor, Professor of Law, University of Maryland; 
  President, Center for Progressive Reform.......................   114

Mr. Michael P. Walls, Vice President of Regulatory and Technical 
  Affairs, American Chemistry Council............................   123

            Appendix II: Additional Material for the Record

Prepared statement by Representative Eddie Bernice Johnson, 
  Ranking Member, Committee on Science, Space, and Technology, 
  U.S. House of Representatives..................................   128

 
                       STATUS OF REFORMS TO EPA'S
                   INTEGRATED RISK INFORMATION SYSTEM

                              ----------                              


                        WEDNESDAY, JULY 16, 2014

                  House of Representatives,
     Subcommittee on Oversight and Subcommittee on 
                                       Environment,
               Committee on Science, Space, and Technology,
                                                   Washington, D.C.

    The Subcommittees met, pursuant to call, at 1:32 p.m., in 
Room 2318 of the Rayburn House Office Building, Hon. Paul Broun 
[Chairman of the Subcommittee on Oversight] presiding.


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Chairman Broun. Good afternoon. This joint hearing of the 
Subcommittee of Oversight and the Subcommittee on Environment 
will come to order. Good afternoon, everyone. We welcome you to 
today's joint hearing. In front of you are packets containing 
the written testimony, biographies, and truth in testimony 
disclosures for today's witnesses.
    Before we get started, since this is a joint hearing 
involving two Subcommittees, I want to explain how we will 
operate procedurally, so all Members understand how the 
question and answer period will be handled. We will recognize 
those Members present at the gavel in order of seniority on the 
Full Committee, and those coming in after the gavel will be 
recognized in the order of arrival.
    And before I give my opening statement, I want to thank--
publicly thank the witnesses, as well as Members, and staff on 
both sides for your flexibility. We have a long series of votes 
that are going to occur about 2:30, 2:45 this afternoon. We 
wanted to have plenty of time for Members, as well as the 
witnesses, to give their statements and ask and answer 
questions, and so I deeply appreciate everyone's flexibility in 
this. Now the Chairman recognizes himself for five minutes for 
an opening statement.
    Again, I would like to welcome and thank all of our 
witnesses for being here today, and for your flexibility in 
coming in early to accommodate our vote schedule. We don't have 
control over such matters, so I especially appreciate you all 
and the Members' cooperation.
    Over the past decade, this Committee has held many 
oversight hearings to examine the EPA's Integrated Risk 
Information System, or IRIS program. As you all know, IRIS was 
established three decades ago to provide a single source of 
information on the risk associated with exposure to 
environmental chemicals for use by EPA regulatory offices, 
states, the international community, as well as industry.
    Unfortunately, the program has come under increased 
scrutiny as a result of issues related to the pace of 
assessments, the lack of transparency, and failure to develop 
and use consistent approaches to weighing evidence, and 
characterizing risk in a manner divorced from actual human 
exposures.
    This scrutiny has come in many forms. Internally, from the 
EPA program offices, which have established their own chemical 
assessments separate from ours, as well as other federal 
agencies, including the White House, and externally from 
stakeholder groups that have increasingly weighed in to express 
their concern about IRIS assessments. Even the U.S. Government 
Accountability Office placed the program on its high risk 
series, a list it provides to Congress every two years, for 
being at high risk for waste, fraud, abuse, and mismanagement, 
or in need of broad based transformation.
    Congress, and especially this Committee, has shined a 
spotlight on the IRIS program for several years, particularly 
as the National Research Council has been directed to review 
some of the more complex and challenging IRIS assessments. One 
such example is the 2011 formaldehyde assessment. When the NRC 
published their review, it went beyond its charge to add a very 
pointed and critical chapter seven in their report that offered 
recommendations and suggestions on how EPA could improve the 
IRIS process. That eventually led to the NRC report published 
this May, which identified ``substantial improvements'' in the 
initial stages of EPA's proposed changes to the IRIS program.
    That is quite a turnaround from the 2011 report, and I was 
pleased to read that, just as I was pleased to read when EPA 
announced two years ago that it had tapped Dr. Ken Olden to 
lead the agency's National Center for Environmental Assessment. 
Dr. Olden has been a refreshing ambassador for the IRIS 
program, and I applaud his commitment to an open and 
transparent IRIS process that includes early communication, and 
increased opportunities for meaningful stakeholder input.
    But it is clear that the objective of transparency is not a 
sentiment shared by all. Unfortunately, we have seen opposition 
to openness, transparency, and greater public comment from some 
corners. Sunshine is the only way to ensure that this reform 
effort succeeds, and anti-industry conspiracy theories, and the 
boycotting of public meetings do not help the program improve. 
Dr. Olden and his staff should be commended for opening up the 
process to all stakeholders, and I greatly appreciate your 
efforts, Dr. Olden, in that regard.
    With that, I am interested in learning more about EPA's 
timeline on when it expects to complete its reform process, 
and, more importantly, when it will publish IRIS assessments 
that reflect the recommendations and suggestions offered by the 
NRC to substantially improve the program.
    IRIS will be considered a success when the science behind 
the assessments is viewed by all stakeholders as rigorous and 
accurate. The real metric for progress for IRIS should be the 
actual content of the assessments. Are they credible? Do they 
correctly characterize risk and uncertainty? Can users trust 
them? Are they overly conservative in a way that limits the 
options available to risk managers? If EPA develops such 
guidelines, handbooks, or policies, then fails to consistently 
follow them, we will have spent years, and millions of 
taxpayers' dollars to reform IRIS on paper.
    As a physician, I understand how important it is to ensure 
the best possible scientific methods are being utilized to 
protect our most sensitive populations, including children, 
pregnant women, and the elderly, all from undue harm. Because 
of this widespread use, we must be certain that the IRIS 
program is using the best possible science, and scientific 
process, in a timely fashion to publish assessments that 
engender confidence by all stakeholders. Anything less than 
that is a mission not accomplished. Thank you.
    [The prepared statement of Mr. Broun follows:]

            Prepared Statement of Subcommittee on Oversight
                          Chairman Paul Broun

    Good afternoon. I want to welcome and thank all of our witnesses 
for being here today.
    Over the past decade, this Committee has held many oversight 
hearings to examine the EPA's Integrated Risk Information System, or 
IRIS program. As you all know, IRIS was established three decades ago 
to provide a single source of information on the risks associated with 
exposure to environmental chemicals for use by EPA regulatory offices, 
states, the international community, and industry. Unfortunately, the 
program has come under increased scrutiny as a result of issues related 
to the pace of assessments, lack of transparency, failure to develop 
and use consistent approaches to weighing evidence, and characterizing 
risks in a manner divorced from actual human exposures.
    This scrutiny has come in many forms: internally, from EPA program 
offices--who have established their own chemical assessments separate 
from IRIS - as well as other federal agencies, including the White 
House, and externally, from stakeholder groups who have increasingly 
weighed in to express their concerns about IRIS assessments. Even the 
U.S. Government Accountability Office placed the program on its High-
Risk series, a list it provides to Congress every two years, for being 
at high risk for waste, fraud, abuse, and mismanagement or in need of 
broad-based transformation.
    Congress, and especially this Committee, has shined the spotlight 
on the IRIS program for several years, particularly as the National 
Research Council has been directed to review some of the more complex 
and challenging IRIS assessments. One such example is the 2011 
formaldehyde assessment. When the NRC published that review, it went 
beyond its charge to add a very pointed and critical Chapter Seven in 
the report that offered recommendations and suggestions on how EPA 
could improve the IRIS process. That eventually led to the NRC report 
published this May, which identified ``substantial improvements'' in 
the initial stages of EPA's proposed changes to the IRIS program.
    That is quite a turn-around from the 2011 report, and I was pleased 
to read that, just as I was pleased when EPA announced two years ago 
that it had tapped Dr. Ken Olden to lead the agency's National Center 
for Environmental Assessment. Dr. Olden has been a refreshing 
ambassador for the IRIS program and I applaud his commitment to an open 
and transparent IRIS process that includes early communication and 
increased opportunities for meaningful stakeholder input.
    But it is clear that the objective of transparency is not a 
sentiment shared by all. Unfortunately, we have seen opposition to 
openness, transparency, and greater public comment from some corners. 
Sunshine is the only way to ensure that this reform effort succeeds, 
and anti-industry conspiracy theories and the boycotting of public 
meetings do not help the program improve. Dr. Olden and his staff 
should be commended for opening up the process to all stakeholders.
    With that, I am interested in learning more about EPA's timeline on 
when it expects to complete its reform process, and more importantly, 
when it will publish IRIS assessments that reflect the recommendations 
and suggestions offered by the NRC to substantially improve the 
program. IRIS will be considered a success when the science behind the 
assessments is viewed by all stakeholders as rigorous and accurate. The 
real metric for progress for IRIS should be the actual content of the 
assessments. Are they credible? Do they correctly characterize risk and 
uncertainty? Can users trust them? Are they overly conservative in a 
way that limits the options available to risk managers? If EPA develops 
useful guidelines, handbooks, or policies, then fails to consistently 
follow them, we will have spent years and millions of dollars to reform 
IRIS on paper.
    As a physician, I understand how important it is to ensure the best 
possible scientific methods are being utilized to protect our most 
sensitive populations, including, children, pregnant women, and the 
elderly, from undue harm. Because of its widespread use, we must be 
certain that the IRIS program is using the best possible science and 
scientific process in a timely fashion to publish assessments that 
engender confidence by all stakeholders. Anything less than that is a 
mission not accomplished.
    Thank you. I now recognize the Ranking Member, the gentleman from 
New York, Mr. Maffei, for anopening statement.

    Chairman Broun. And now I recognize the Ranking Member of 
the Environment Subcommittee, Ms. Bonamici, for an opening 
statement.
    Ms. Bonamici. Thank you very much, Mr. Chairman. And thank 
you to our witnesses for testifying before the Subcommittees 
today. I want to note that the absence of more Members on this 
side is not indicative of our concern about the issue. The 
change in time and conflicting hearings are to blame.
    So I also want to start by emphasizing, on behalf of my 
colleagues on my side of the aisle, that we are not anti-
industry, nor are we opposed to the development of new 
chemicals. We simply want to ensure that scientific information 
is available to determine the health effects that might result 
from exposure. This is about protecting human health. I am glad 
you recognize that, Mr. Chairman.
    The Integrated Risk Information System, IRIS, was intended 
to be a database that would provide a comprehensive source of 
best information on the health risks of chemicals. 
Approximately 700 new chemicals enter the market every year, 
joining about 85,000 industrial chemicals already in use. 
Companies that manufacture, distribute, or use these chemicals 
are not required to demonstrate that the chemicals are safe.
    When a company wants to introduce a new chemical, the 
company notifies the EPA, but the company is not required to 
share any data regarding the safety of that chemical. EPA 
cannot even request safety data unless it can show that there 
is a potential risk by pointing to available academic or 
industry data. It often takes many years before harms 
associated with the chemical can begin to be identified. Thus, 
there is no good public safety check in place.
    There is what seems to be an obvious need for transparency. 
Despite that, since the 1990s, the industry appears to have 
used some strategies to try to slow IRIS entries, tie EPA up in 
lengthy reviews and inter-agency dialogues, or generally cast 
doubt on claims that a particular chemical might have an 
adverse health effect.
    For example, during the Bush Administration, the Office of 
Management and Budget hired a toxicologist and epidemiologist 
to run so-called peer reviews of draft IRIS entries, a policy 
that resulted in endless requests from OMB that EPA go back and 
look at different literature, or make minor changes to their 
findings. The Bush Administration also created an inter-agency 
review process that allowed agencies with significant pollution 
problems to challenge the EPA IRIS drafts. Production of new 
IRIS assessments was so slow that the GAO put IRIS on their 
watch list--you mentioned that, Mr. Chair--and there was a 
bipartisan push to let EPA take control of their program and 
expand their productivity.
    The Obama Administration sought to strengthen IRIS, and 
moved OMB into the background while lessening unnecessary 
inter-agency review mechanisms. The response from those who are 
opposed to IRIS has been to call on the National Research 
Council to continually review IRIS assessments. The NRC was 
drawn into IRIS several times prior to the 2011 formaldehyde 
review. In each case, they largely supported EPA's findings, 
but offered advice about how to complete more systematic 
reviews, and how to improve the science assessments. 
Invariably, the overall assessments of EPA's findings were lost 
in the noise about what the EPA did not do, or could have done 
better.
    The 2011 report was a little different. The National 
Research Council used that report to praise the substantial 
improvements--thank you, Dr. Olden--made by the EPA thus far, 
and offer a road map how to make IRIS more efficient to 
accelerate and streamline the assessments. EPA embraced the 
advice of the NRC, and, as the most recent report acknowledges, 
has made significant progress in putting into place the process 
reforms recommended in 2011.
    Now we are faced with a question. What is the National 
Academy's off-ramp strategy for getting out of the business of 
doing endless IRIS reviews? Questions have been raised about 
whether the American Chemistry Council may have an interest in 
keeping IRIS unproductive. Does every NRC report offer an 
opportunity for criticisms about the quality of the science at 
the EPA? These are issues we hope you will address today.
    At this point I am very interested to hear whether the 
Academy has reached the end of its productive contributions. If 
not, where is that point? Frankly, the combination of the 2011 
report, the new leadership at the Center for Environmental 
Assessment, which has focused on building a better relationship 
with industry, has had the effect of crippling IRIS, rather 
than putting the EPA on a path to streamline production of IRIS 
entries. In fact, unless changes are implemented, it very well 
may cripple the program as much as when OMB was involved, with 
repeated peer reviews. So I am very interested to hear from Dr. 
Olden what you intend to do to get production of IRIS 
assessments moving.
    I look forward to the testimony from each of the witnesses. 
There have been a lot of questions raised, but, importantly, 
this Committee needs to hear how we are going to get out of the 
way, let EPA do its job of producing assessments of chemicals 
that may be suspected of, and may be causing harm to our 
constituents and our communities. Thank you very much, Mr. 
Chairman, and I yield back.
    [The prepared statement of Ms. Bonamici follows:]

           Prepared Statement of Subcommittee on Environment
                Ranking Minority Member Suzanne Bonamici

    Thank you, Mr. Chairman, and thank you to our witnesses for 
testifying before our Subcommittees today. I want to start by 
emphasizing on behalf of my side of the aisle that we are not anti-
chemical or opposed to the development of new chemicals--we simply want 
to assure that scientific information is available to determine the 
health effects that might result from exposure. This is about 
protecting human health.
    The Integrated Risk Information System, IRIS, was intended to be a 
database that would provide a comprehensive source of best information 
on the health risks of chemicals. Approximately seven hundred new 
chemicals enter the market every year, joining about 85,000 industrial 
chemicals already in use. Companies that manufacture, distribute, or 
use these chemicals are not required to demonstrate that the chemicals 
are safe.
    When a company wants to introduce a new chemical, the company 
notifies the EPA, but the company is not required to share any data 
regarding the safety of that chemical. EPA cannot even request safety 
data unless it can show there is a potential risk by pointing to 
available academic or industry data. It often takes many years before 
harms associated with a chemical can begin to be identified, thus there 
is no good public safety check in place.
    There is what seems to be an obvious need for transparency. Despite 
that, since the 1990s the chemical industry appears to have used 
strategies to try to slow IRIS entries, tie EPA up in lengthy reviews 
and interagency dialogues, and generally cast doubt on claims that a 
particular chemical might have an adverse health effect. For example, 
during the Bush Administration, the Office of Management and Budget 
hired a toxicologist and an epidemiologist to run so-called ``peer 
reviews'' of draft IRIS entries, a policy that resulted in endless 
requests from OMB that EPA go back and look at different literature or 
make minor changes to their findings. The Bush Administration also 
created an interagency review process that allowed agencies with 
significant pollution problems to challenge the EPA IRIS drafts. 
Production of new IRIS assessments was so slow that GAO put IRIS on 
their ``watch list,'' and there was a bipartisan push to let EPA take 
control of their program and expand their productivity.
    The Obama Administration sought to strengthen IRIS, and moved OMB 
into the background while lessening unnecessary interagency review 
mechanisms. The response from those who are opposed to IRIS's work has 
been to call on the National Research Council to continually review 
IRIS assessments. The NRC was drawn into IRIS several times prior to 
the 2011 Formaldehyde review. In each case they largely supported EPA's 
findings, but offered advice about how to complete more systematic 
reviews and how to improve the science assessments. Invariably, the 
overall endorsements of EPA's findings were lost in the noise about 
what EPA did not do or could have done better.
    The 2011 report was a little different. The National Research 
Council (NRC) used that report to praise the substantial improvements 
made by EPA thus far, and offer a road map for how to make IRIS more 
efficient, and to accelerate and streamline the assessments. EPA 
embraced the advice of the NRC and, as the most recent report 
acknowledges, has made significant progress in putting into place the 
process reforms recommended in 2011. Now we are faced with a necessary 
question: what is the National Academy's off-ramp strategy for getting 
out of the business of doing endless IRIS reviews? Organizations such 
as the American Chemistry Council may have an interest in keeping IRIS 
unproductive, and discrediting its work could keep the Academy busy as 
every NRC report offers an opportunity for criticisms about the quality 
of the science at EPA. At this point, I am very interested to hear 
whether the Academy has reached the end of its productive 
contributions. If they have not reached that point, where might that 
point be?
    Frankly the combination of the 2011 report and the new leadership 
at the National Center for Environmental Assessment, which has focused 
on building a better relationship with industry, has had the effect of 
crippling IRIS rather than putting the EPA on a path to streamlined 
production of IRIS entries. In fact, unless changes are implemented, it 
may very well cripple the program as much as when OMB was involved with 
repeated ``peer reviews.'' So I am very interested to hear from Dr. 
Olden about what he intends to do to get production of IRIS assessments 
moving.
    I look forward to the testimony from each of the witnesses. But 
importantly, this Committee needs to hear how we are going to get out 
of the way and let EPA do its job of producing assessments of chemicals 
that are suspected of and may be causing harm to our constituents and 
our communities.

    Chairman Broun. Thank you, Ms. Bonamici. Now the Chair 
recognizes the Chairman of the Subcommittee on Environment, the 
gentleman from Arizona, Mr. Schweikert, for his opening 
statement. You are recognized for five minutes.
    Mr. Schweikert. Thank you, Mr. Chairman. We will do this 
quickly, to be economical with time, because of the votes 
coming up. Welcome to the chaos of this time of year.
    I have three quick things. One, I need to say goodbye to 
Mr. Woods here, though his unwillingness to shave demonstrates 
he knows he is leaving us this coming week. Number two, 
something that almost has never happened in my couple years 
around here, I talked to some folks who care very much about 
what is done here, and they actually said nice things about 
you, Dr. Olden. You have no idea how rare it is to hear nice 
things about anyone around here.
    And, number three, one of the comments that came up, both 
from some folks I met who you consider on the left and the 
right, is the encouragement and the hope that the continued 
movement to be more transparent with data, so folks can review 
and understand, continues. There was a great warmth from both 
sides that was heading in the right direction. With that, Mr. 
Chairman, I yield back.
    [The prepared statement of Mr. Schweikert follows:]

             Prepared Statement of Environment Subcommittee
                       Chairman David Schweikert

    EPA's Integrated Risk Information System, or ``IRIS,'' is designed 
to provide quantitative and non-quantitative toxicity information for a 
suite of chemicals. The purpose of this program is to provide basic 
scientific determinations about what is a safe level and to be used by 
both EPA program offices and States.
    This program has never been authorized by Congress and, over the 
last decade, has been strongly criticized by the National Academy of 
Sciences, the Government Accountability Office (it was listed as a 
``High risk'' program in 2009 and remains on the list), the 
environmental community, industry, and both parties.
    The National Research Council rightly found that critical reforms 
that promote greater openness, transparency, and stakeholder engagement 
are currently underway by EPA, led by Dr. Ken Olden.
    It is important to note that these limited reforms are simply a 
work in progress--not a single complete assessment has benefited from 
this new framework. The NRC report was a snapshot in time, and even 
these limited reforms have been criticized in some corners.
    Specifically, the NRC called on EPA to:

      Increase the transparency of how IRIS assessments are 
conducted and of the criteria EPA uses;

      Adopt better methodologies for systematic review of the 
literature, for evaluating evidence, and for integrating evidence 
across different types of scientific information;

      Rely on more high quality studies;

      Conduct better peer review;

      Increase the role of outside experts; and

      Better manage the program to improve its efficiency and 
to stay current with scientific advances.

    Most of these reforms have focused on process, but there are key 
areas in the content of these assessments that limit their credibility. 
States, industry, and the public do not trust the IRIS assessments.
    The former Science Advisor for EPA recently wrote in Nature that: 
``Fundamentally, the EPA should replace risk values that are built on 
science-policy assumptions with risk estimates that acknowledge 
underlying uncertainties. The EPA's definitive values are illusions; 
they conceal uncertainty that cannot be resolved scientifically.''

    Chairman Broun. Well, that was quick. Thank you, Mr. 
Schweikert. If there are Members who wish to submit additional 
opening comments or statements, your statements will be added 
to the record at this point.
    Chairman Broun. At this time I would like to introduce our 
panel of witnesses. Our first witness is Dr. David Dorman, 
member of the National Research Council's Committee to Review 
the EPA's IRIS Process.
    Our second witness, and star, is Dr. Ken Olden, Director of 
the National Center for Environmental Assessment at the U.S. 
Environmental Protection Agency. And, I just want to reiterate 
what Mr. Schweikert said. It is just so nice to have good 
comments, and it is rare around here, Dr. Olden.
    Our third witness is Ms. Rena Steinzor, Professor of Law at 
the University of Maryland, and President of the Center for 
Progressive Reform. Glad to have you, as well as our final 
witness, Mr. Michael Walls, Vice President of Regulatory and 
Technical Affairs at the American Chemistry Council.
    Now, as the witnesses should know, spoken testimony is 
limited to five minutes each, and if you would please try to 
limit your comments to five minutes. I am not going to gavel 
you down, but we do have votes forthcoming fairly quickly. So 
if you would, please try to limit your comments to five 
minutes, after which Members of the committee will have five 
minutes each to ask questions.
    It is the practice of the Subcommittee on Oversight to 
receive testimony under oath. If you would all please stand. 
Raise your right hand. Do you solemnly swear to affirm to tell 
the whole truth, and nothing but the truth, so help you God? 
Dr. Dorman? Okay, very good. You may be seated. Let the record 
reflect that the witnesses participating have all taken the 
oath.
    I now recognize Dr. Dorman for five minutes.

                 TESTIMONY OF DR. DAVID DORMAN,

        MEMBER, COMMITTEE TO REVIEW EPA'S IRIS PROCESS,

                   NATIONAL RESEARCH COUNCIL

    Dr. Dorman. Okay. Good afternoon, Dr. Broun, Chairman 
Schweikert, Ranking Member Bonamici, and other Members of the 
Subcommittees. My name is David Dorman. I am a professor of 
toxicology at North Carolina State University, and I served as 
a member of the National Research Council Committees to review 
the IRIS process, and the NRC Committee to review EPA's draft 
IRIS assessment of Formaldehyde. I am pleased to appear before 
you today to discuss aspects of the report, ``Review of EPA's 
Integrated Risk Information System Process'', which was 
released earlier this year, in May of 2014.
    This report, which I have a copy of, and--was written by a 
15 member committee of the National Research Council of the 
National Academies. The committee was asked to assess the 
scientific, technical, and process changes being implemented or 
planned by EPA, and to recommend modifications, or additional 
changes, as appropriate, to try to improve the scientific and 
technical performance of the IRIS process. Recommendations in 
the earlier NRC formaldehyde report, as mentioned earlier, 
provided the impetus for the changes to EPA's IRIS program.
    Overall, the IRIS committee found that the changes that EPA 
has proposed and implemented to various degrees constitute 
substantial improvements in the IRIS process. If current 
trajectories are maintained, some of the inconsistencies 
identified in our report are addressed, and planned revisions 
still to be implemented are successfully completed, the IRIS 
process will become much more effective and efficient in 
achieving the program's basic goal of developing assessments 
that provide an evidence-based foundation for ensuring that 
chemical hazards are optimally addressed, and assessed through 
a transparent and replicable approach.
    The IRIS committee reviewed and evaluated the overall 
process, and each individual step of the process, and the 
changes that EPA has made, or is planning to make, and offered 
recommendations. Additionally, the IRIS committee identified 
three broad areas on which the EPA should focus attention.
    First, EPA's assessment methods will need to be updated in 
a continuing strategic process, and EPA should develop a plan 
for doing so. Second, the sources of inefficiencies in the IRIS 
process need to be identified and addressed systematically. 
Third, EPA management needs to evaluate human and technologic 
resources that are needed to conduct IRIS assessments, and 
support methodologic research, and the implementation of new 
approaches. The IRIS committee emphasized that if sufficient 
financial and staff resources are not available to EPA, then it 
will not be able to continue to improve the IRIS program, and 
keep pace with scientific advancement.
    As noted, the IRIS committee found that substantial 
improvements in the IRIS process have been made, and it is 
clear that EPA has embraced, and is acting on the 
recommendations in the NRC formaldehyde report. The NRC 
formaldehyde committee recognized that these suggested changes 
would take several years, and an extensive effort on the part 
of EPA staff to implement. Substantial progress, however, has 
been made in a short time, and the IRIS committee's 
recommendation should be seen as building on the progress that 
EPA has already made.
    Thank you for the opportunity to testify, and I would be 
happy to answer any questions that the Committee would like me 
to address. Thank you.
    [The prepared statement of Dr. Dorman follows:]
    
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    Chairman Broun. Thank you, Dr. Dorman. The Chair now 
recognizes Dr. Olden for five minutes.

           TESTIMONY OF DR. KENNETH OLDEN, DIRECTOR,

         NATIONAL CENTER FOR ENVIRONMENTAL ASSESSMENT,

              U.S. ENVIRONMENTAL PROTECTION AGENCY

    Dr. Olden. Good afternoon, Chairman Broun, Ranking Member 
Maffei, Chairman Schweikert, and Ranking Member Bonamici, and 
distinguished Members of the Committee. My name is Kenneth 
Olden, and I am the director of the National Center for 
Environmental Assessment, in the Office of Research and 
Development in the U.S. Environmental Protection Agency. We 
appreciate your interest in the Integrated Risk Information 
System, commonly called IRIS. Today I am pleased to report that 
the changes that we have made in the program over the past two 
years have been welcomed, and well received.
    A May 2014 report by the National Academies National 
Research Council commended our progress, and recognized that we 
have made a tremendous amount of progress in a short time. Yes, 
we are pleased that the NRC committee recognized the progress 
that we have made. However, it is not time to celebrate, or to 
declare victory. In fact, we are humbled by the work that 
remains to be done.
    Our vision is to complete the transformation of IRIS into a 
highly effective world class scientific enterprise. To achieve 
this objective, the IRIS program has embraced the use of the 
best science and informational technologies available to 
estimate the risk from chemical exposures. Furthermore, we have 
instituted several structural and programmatic changes to 
ensure transparency, objectivity, and scientific rigor in the 
assessment process.
    In the interest of time, I will highlight three in my oral 
testimony today. First, we incorporated principles of 
systematic structured review methodologies to identify, to 
evaluate, and to integrate data from the three different 
evidence streams that we use in toxicity--in estimation of 
toxicity values. These approaches make use of explicit pre-
specified rules to select, to evaluate, and to synthesize data 
relevant to the specific chemical assessment. Such approaches 
give results that are highly reproducible, and eliminate bias 
associated with expert judgment.
    However, I might add that methodologies used in systematic 
review and evidence integration were developed for the use of 
evidence medicine. In such cases, one is comparing 
effectiveness of Drug A versus Drug B in a chemical trial. In 
the case of IRIS assessments, we are integrating evidence from 
three streams, epidemiology, animal studies, and mode of 
action, or mechanistic studies.
    Except for the Bradford-Hill guidelines used in cancer 
hazard assessment, the effectiveness and potential for risk of 
bias for integration of evidence from such diverse sources 
using these methodologies have not been evaluated. While useful 
in evidence-based medicine, these methodologies may need to be 
customized for IRIS purposes. However, I caution that we do not 
want to make the structured process so rigid as to exclude 
expert judgment. In the end, we may end up with a process that 
combines expert judgment with some sort of structured approach.
    Second, we instituted activities to proactively engage the 
public during critical stages of the assessment process. For 
example, we hold bimonthly IRIS public meetings to discuss 
scientific issues related to preliminary assessment materials 
and draft IRIS assessments. These meetings provide opportunity 
for public input on the literature identified, and evidence 
tables that we have prepared for use in the assessment. For 
example, have we failed to identify all the studies pertinent 
to the assessment? Have we identified the right disease 
endpoints likely to be caused by the specific chemical 
exposure?
    And finally, to improve quality and consistency of peer 
review, we have created a standing chemical assessment advisory 
committee under the auspices of EPA's Scientific Advisory Board 
to conduct peer review of IRIS assessments. Since we will have 
regular and frequent interactions with this committee, systemic 
and recurring problems can be defined and eliminated, and 
consensus opinions of the committee will provide quality 
assurance, and will lend credibility to the assessments. 
Moreover, impetus to be responsive to the peer review 
recommendations will be much higher. However, it is my job to 
ensure the quality and integrity of IRIS assessments.
    And, in summary, the transformation of IRIS is well 
underway. As the individual with primary responsibility for the 
IRIS program, I can assure you that the EPA fully intends to 
successfully complete the transformation. The recommendations 
made by the NRC committees are absolutely consistent with our 
commitment to transparency and scientific excellence. While we 
are fully cognizant of the urgency to completely implement the 
NRC recommendations, our number one priority is to get the 
science and the process right.
    Thank you, and I would be pleased to respond to any 
questions that you might have.
    [The prepared statement of Dr. Olden follows:]
    
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    Chairman Broun. Thank you, Dr. Olden. Ms. Steinzor, you are 
recognized for five minutes.

                TESTIMONY OF MS. RENA STEINZOR,

           PROFESSOR OF LAW, UNIVERSITY OF MARYLAND;

            RESIDENT, CENTER FOR PROGRESSIVE REFORM

    Ms. Steinzor. Thank you for the opportunity to testify this 
afternoon about how to get EPA's IRIS program back on track. 
IRIS assessments are invaluable because they are robust and 
well documented, are summarized clearly and concisely, and are 
available to anyone who has access to the Internet. 
Individuals, community groups, public interest organizations, 
government officials, in short, everyone, not just in this 
country, but around the world, can get information they need to 
make well informed decisions about toxic hazards. Conversely, 
delaying the production of IRIS profiles causes real and 
devastating harm to public health. It also saves the chemical 
industry lots of money.
    My testimony today makes three points. First, IRIS 
assessments have once again slowed to a crawl, sinking to the 
depths of the poor performance achieved under the Bush 
Administration. The Obama Administration needs to stop 
jawboning with industry stakeholders, and concentrate on 
revitalizing this vital initiative.
    The highest best use of the National Academy's expertise 
would be to help the IRIS program identify ways to develop a 
significantly larger number of robust assessments quickly, on a 
limited budget. Congress, the EPA administrator, and the 
National Academies must confront the very serious problem of 
regulated industry's commandeering the IRIS assessment process 
by barraging the agency with endless minor repetitive and 
irrelevant objections to risk assessments.
    Unfortunately, although its potential is great, IRIS's 
promise is compromised by disturbing data gaps. As GAO has 
reported, IRIS is rapidly becoming one of EPA's walking dead 
programs. The agency's efforts to fill IRIS's data gaps were 
largely stymied during the Bush Administration, and not by 
accident. That administration imposed reforms designed to 
subject EPA's scientists to a host of political pressures from 
government agencies with neither scientific expertise, nor an 
interest in protecting public health and the environment.
    The Obama Administration recognized the problem, but its 
revisions to the IRIS process left key issues unaddressed. Of 
late, the administration has displayed a disturbing tendency to 
retreat in the face of a blistering and self-serving industry 
campaign to stifle this vital program once and for all.
    The two National Academies committees responsible for 
reviewing IRIS have missed golden opportunities to provide 
constructive advice on how to develop new assessments quickly. 
Rather than flyspecking the faults of specific IRIS 
assessments, and subjecting the program as a whole to a round 
robin of highly critical examination, three issues must be 
addressed to solve this problem, revamping the IRIS program's 
agenda, adopting so-called stopping rules, and ending 
duplicative rounds of stakeholder consultations dominated by 
regulated industries.
    Once EPA starts an IRIS assessment, there must be an end in 
sight, an assessment must be declared finished, and its results 
posted on the web. When significant new science is produced 
suggesting that the numbers must be lowered or raised, EPA can 
re-examine the profile. But as exemplified by the chromium 
compound assessment, regulated industries often manage to push 
EPA onto a treadmill, where it never escapes the wait for 
another study. The trouble, of course, is that science is 
always evolving. EPA cannot wait on all the science to resolve 
itself, and the truth to be announced. That simply is not the 
nature of the scientific enterprise.
    The final problem is the decision by EPA political 
appointees to deal with the attacks on IRIS by hosting numerous 
stakeholder engagement events, some tied to specific 
assessments, others related to broader science issues, or even 
general concerns about the program as a whole. EPA's political 
appointees seem to harbor the naiive idea that this process 
will placate its critics. Instead, endless jawboning has left 
the agency vulnerable to cynical exploitation.
    In sum, let us not lose sight of what is really at stake, 
the priceless notion that the water we drink and the air we 
breathe ought to be clean and healthy. Thank you.
    [The prepared statement of Ms. Steinzor follows:]
    
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    Chairman Broun. Thank you, Ms. Steinzor. Mr. Walls, you are 
recognized for five minutes.

               TESTIMONY OF MR. MICHAEL P. WALLS,

      VICE PRESIDENT OF REGULATORY AND TECHNICAL AFFAIRS,

                   AMERICAN CHEMISTRY COUNCIL

    Mr. Walls. Good afternoon, Dr. Broun, Ranking Member 
Bonamici, Chairman Schweikert, and the Members of the 
Committee. We very much appreciate the opportunity to appear 
here today to comment on progress in the IRIS program.
    You can count me among the fans of Ken Olden. We would like 
to compliment Ken for his leadership in the IRIS program. The 
changes he has instituted since the NAS report in 2011 is--are 
bringing IRIS closer to a high standard of public engagement, 
transparency, and openness. We share his interest, and the 
program's interest, in assuring that IRIS assessments can help 
EPA and others do a better job of protecting health and the 
environment.
    We are concerned, however, that some of the policies and 
practices in the program continue to perpetuate the development 
of unrealistic overestimates of risk. These shortcomings can 
have real, if unintended, consequences. And that is because the 
risk management decisions that are made by federal and state 
governments, for example, routinely draw upon the numbers 
generated in assessment programs like the IRIS program.
    Now, ACC recently released a set of principles that set out 
attainable high level benchmarks for federal assessment 
programs. Our principles focus on four areas, improvement in 
assessment design, improvement in data and method integration 
and review, how those assessments are communicated, and review 
and accountability in those programs. Our principles are 
consistent not only with the NAS reports, but are consistent as 
well with the administration's own science integrity goals.
    At this point in time, however, and I think as Dr. Olden 
has noted, much work remains to be done to ensure those 
benchmarks are achieved in the program. The 2011 report 
identified significant scientific shortcomings in the program. 
EPA, to its credit, is committed to fully implementing those 
recommendations.
    But now, three years after the 2011 report was released, 
many of the most critical changes remain to be fully 
implemented. In fact, materials released by the agency just 
last week--in those materials released just last week, EPA 
indicated that only two of the chemicals now in the IRIS 
pipeline even have any chance of being fully consistent with 
the 2011 recommendations, as well as the enhancements that Dr. 
Olden himself has implemented. The NAS's 2014 report 
acknowledged that progress has been made. It also reiterated 
several of the same concerns noted in 2011, and made further 
recommendations for improvement.
    Now, in our view, the most critical area for IRIS reform is 
evaluating and integrating scientific evidence in a transparent 
and robust manner. For example, IRIS has identified study 
quality considerations for certain scientific evidence, but the 
assessments have not systematically and transparently evaluated 
the studies against those considerations. NAS recommended that 
in 2011, and did so again in 2014.
    IRIS assessments needs to consistently address mode of 
action. That is how the human body works, and the way the 
chemicals interact with the body at different levels of 
exposure. But EPA's approach, however, has left stakeholders 
guessing about how mode of action and mechanistic information 
will be used. If IRIS assessments are designed well from the 
very beginning, the agency can organize the available 
information to evaluate the plausible alternative hypotheses, 
and they can do so in a much more timely way. They will be much 
more productive at getting assessments completed. We think EPA 
should also articulate a better standard for using data, 
instead of default assumptions, as well as more effectively 
addressing peer review.
    Finally, how the agency characterizes and communicates this 
information to the public is critically important. When 
assumptions are used in lieu of data, the assumptions should be 
disclosed, along with the justification for their use. The NAS 
this year called on the EPA to develop guidelines for 
uncertainty analysis and communication. The IRIS assessments 
themselves should provide a complete picture of what is known 
and what is inferred.
    But just this past Monday, at a meeting of the chemical 
assessment advisory committee, in their review of the ammonia 
assessment, it demonstrated that the panel itself couldn't 
figure out why EPA--how EPA chose some numbers, and why they 
did that. So we are looking forward to continuing our work with 
your Committee, with Dr. Olden, and other stakeholders to make 
sure that the NAS recommendations, as well as the principles we 
have articulated are implemented in the program.
    We hope, in fact, that other EPA program offices, and other 
federal agencies, will carefully consider the recommendations 
by the NAS to make appropriate improvements in their own 
programs. We share a mutual interest in ensuring that high 
quality information is applied to make better, more timely 
public health decisions. Thank you.
    [The prepared statement of Mr. Walls follows:]
    
    
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    Chairman Broun. Thank you, Mr. Walls. We have been informed 
that we are going to start having votes at about 2:10, about a 
minute or a minute and a half from now, and it is going to be 
long series. So, to try to expedite things, and get to as many 
Members as we possibly can, the minority and I have agreed that 
we are going to limit each Member to three minutes so that we 
can try to get through as many Members as possible. We will 
offer you all the opportunity to answer questions, and their 
questions for the record, QFRs, as we normally call them, so 
please be expeditious in giving those back to us. Thank you all 
for your testimony. I will open the first round of questions 
now, and I recognize myself for three minutes.
    Dr. Olden, as I mentioned in my statement, I appreciate all 
of your efforts to reform the IRIS program, including your 
attempts to increase transparency and stakeholder input. I do 
wonder, however, when will this process be completed, and when 
will the EPA publish its first IRIS assessment that will 
reflect all of the recommendations and suggestions offered by 
NRC to substantially improve the program?
    And then, furthermore, do you anticipate the first couple 
of IRIS assessments that will incorporate all of the NRC 
recommendations to be on new chemicals, and if so, which ones 
will be first, or will there be updates of old assessments, and 
if so, which ones?
    Dr. Olden. Chairman Broun, any chemical that was started 
after the 2011 formaldehyde report will have all the 
recommendations that were included in the formaldehyde NRC 
committee report. So how many chemicals that is, I am not 
absolutely certain. But I would say by--in three to five years 
we will have completely implemented all the recommendations of 
the NRC reports.
    Chairman Broun. Are you talking about three to five years 
from now, or when you began the process?
    Dr. Olden. --three to five years from now.
    Chairman Broun. Okay.
    Dr. Olden. Right.
    Chairman Broun. Are new chemicals involved in the 
assessment, or are you just going to do old ones? And which 
ones are you going to test?
    Dr. Olden. There are new chemicals in the pipeline that 
will be involved in the assessment. And there are probably some 
old ones. I can get back to you with the specifics. But there 
will be both new, and possibly some old chemicals.
    Chairman Broun. Okay.
    Chairman Broun. Can you give us a number?
    Dr. Olden. What we are doing now is doing a strategic--long 
term strategic planning to identify the needs of the agency. 
And once we get--so we send a survey out to all the program 
directors and regional directors, and we are getting that 
information back. When we assemble that information, we will 
make--know which chemicals the agency needs, and we will make 
assessment of those chemicals our highest priority.
    Chairman Broun. Thank you, Dr. Olden. Ms. Bonamici, you are 
recognized for three minutes.
    Ms. Bonamici. Thank you very much, Mr. Chairman.
    Ms. Steinzor, you mentioned in your testimony some of the 
health effects of chemicals for which IRIS has provided 
scientific documentation, for example--or scientific 
determinations, excuse me, brain damage, cardiovascular 
illness, reproductive dysfunction, cancer. That is a list that 
should cause us to pay attention, and I want to bring up 
something that you mentioned in your written testimony, the 
January 2014 chemical spill in West Virginia. As you indicated 
in your testimony at the time of the spill, the chemical being 
used, called Crude MCHM, was not in the IRIS database.
    So, briefly, and then I will ask you to expand in writing, 
under the current IRIS and EPA process, what would have to 
happen before a chemical like MCHM would be subject to an IRIS 
assessment?
    Ms. Steinzor. Well, the problem with that chemical is it is 
not listed in any of the statutes, such as the Clean Air Act or 
the Safe Drinking Water Act, as being a contaminant of concern, 
and yet we saw that it caused very grave problems in West 
Virginia. For it to make its way onto the IRIS list, and 
actually have an assessment completed, our calculations are it 
would take decades at the rate they are going, and that is very 
unfortunate.
    As you know, the people there have been told that they need 
to make a personal decision about whether to shower, or bathe 
their babies in the water.
    Ms. Bonamici. And I am going to try to get a couple more 
questions in. Now, recently this Committee took up a bill 
alleging secret science at the EPA. We hear a lot about the 
need for transparency. Now, it is my understanding that the 
companies do not have to demonstrate the safety of their 
products. And, in fact, safety data is often treated as 
proprietary. So we all know that we need chemicals for modern 
society, but how can we be confident that the chemicals in the 
marketplace are not harming us?
    Ms. Steinzor. I don't think we can be confident, as the 
West Virginia example shows, and I would urge you to take a 
very careful look at that bill. That bill would make it even 
more difficult for EPA to assess chemicals by raising the 
burden of what kind of evidence they have to have, in lieu of a 
testing requirement, very high.
    Mr. Walls. Ms. Bonamici, may I make a comment quickly on 
that?
    Ms. Bonamici. Well, I only have 41 seconds. For the record, 
please do submit.
    Dr. Dorman, thank you for the Academy--for all your work 
that you have done. Can you tell me when the Academy's work 
will be completed, and at what point will you be finished with 
changing the process, or contributing to the process?
    Dr. Dorman. So with respect to the report that was issued 
in May, I mean, that is a project that has been completed. One 
of the things to keep in mind is that the Academy's activities, 
having been a member of several committees now, have largely 
been directed by either Congress, mandated by Congress, or else 
requested by EPA. And so, really, a lot of the work that the 
Academies is doing with respect to the IRIS program is being 
driven by those factors.
    Ms. Bonamici. And do you still have productive 
contributions to make?
    Dr. Dorman. So right now to my knowledge, the Academies--
the only IRIS process--one that we are looking at right now, or 
the Academies is looking at, is related to arsenic.
    Ms. Bonamici. Thank you. I am out of time, and, Dr. Olden, 
I will be submitting more questions for the record. I yield 
back----
    Chairman Broun. Thank you, Ms. Bonamici.
    Chairman Schweikert, you are recognized for three minutes.
    Mr. Schweikert. Thank you, Mr. Chairman. It feels sort of 
like the lightning round. As Ms. Bonamici touched on, one of 
the benefits, obviously, of the Secret Science Bill is if EPA 
uses industry data, it has to become public. The baseline data 
sets become public. So I am hoping that actually sort of 
provides a benefit for everyone.
    Mr. Dorman, I have one concern, and let us see if I can 
articulate this quickly. A standard parts per million is 
created in this process. Don't we have OSHA, CDC, even other 
parts of EPA, and then on occasion I will see European 
standards, as well as others. Are we in a world right now where 
we have lots and lots of different benchmarks being offered? Is 
there a need to start trying to do a consolidation of what is 
the standard of health attributes? And then--first that one, 
then there is an auxiliary to that.
    Dr. Dorman. So you raise a great point. There are a number 
of different agencies charged by individual companies, or 
countries, to try to come up with different types of exposure 
standards, for example, Health Canada versus EPA, and sometimes 
there are divergent numbers that are developed both within the 
United States and elsewhere. A lot of that depends upon what 
the populations at risk sometimes represent. So, for example, 
if OSHA is creating a standard for workers, that standard may 
be very different than what EPA is required to do for the 
general population.
    But the methodologies--I think one of the things that our 
committee was stressing is that in any case, what EPA--when 
they are developing those numbers, try to be as transparent as 
possible so people can look at how those numbers were actually 
developed.
    Mr. Schweikert. Okay. Mr. Dorman, so, if we knew all these 
different regulators that are publishing data on different 
chemicals are following a standardized methodology for 
analysis----
    Dr. Dorman. Right.
    Mr. Schweikert.----, then there is the next part of that. 
Instead of saying, here is my benchmark, it is blank parts per 
million, shouldn't it be blank parts per million when handled 
in this fashion? In this fashion, you might have other types of 
mitigation. Are we also doing a good enough job providing those 
other levels a definition of it also has to do with 
environment, being used in industry, mechanics, the other 
attributes around it?
    Dr. Dorman. Right. So, very quickly, again, it comes back 
to--for example, on the OSHA numbers, those oftentimes will 
look at personal protection, which was--not be available to the 
general population, which EPA is now viewing for, say, the RFC 
or RFD values. So these numbers that EPA is developing are for 
unprotected populations at risk.
    Mr. Schweikert. Okay. And, Mr. Chairman, I promise all of 
you I will have some questions in writing. I have a sort of a 
fixation on data, whether you think it helps you or hurts you, 
becoming public, because I think we need to also trust the kids 
at a university, a left wing group, a right wing group, from 
being able to have opportunities to analyze data, and compare 
with other data sets. With that, I yield back, Mr. Chairman.
    Chairman Broun. Thank you, Mr. Schweikert. Ms. Clark, you 
are recognized for three minutes.
    Ms. Clark. Thank you, Mr. Chairman.
    Dr. Dorman, when Dr. Samet testified before this Committee 
on the 2011 formaldehyde report, he made it very clear that the 
NAS panel was not calling for the EPA to suspend IRIS 
assessments, and was not saying that they could not do quality, 
solid assessments. Instead, was recommending reforms in the 
process that could be implemented in parallel with continuing 
IRIS assessments. Can you tell me, is that still the position 
of the NAS panel?
    Dr. Dorman. So I think that Dr. Samet's comments were 
echoed in our recent IRIS report, and----
    Ms. Clark. Um-hum.
    Dr. Dorman. --the bottom line is that for EPA, when the 
Committee was trying to look at the changes that EPA was 
making, those were in progress. And so what we felt as a 
committee, and felt strongly, was that implementation of 
different attributes within the process may take different 
periods of time in order to fully implement. And so we 
recognize that, both in the formaldehyde report that I served 
on, as well as the IRIS committee.
    And so I think the bottom line was neither committee had 
the anticipation that we would see full cloth changes, but 
rather we were seeing a progress that was occurring, that we 
could then judge to see where they were going.
    Ms. Clark. And in both the new report, and in your 
testimony, it was found there were substantial improvement in 
EPA's process, in line with those recommendations from 2011. Do 
you see any evidence that EPA is producing what some have 
called flawed assessments?
    Dr. Dorman. So I think it is important that we were charged 
with looking at the process, rather than any individual 
assessments, per se. So we weren't asked to do any independent 
assessments, or reviews of assessments, but what we did see was 
a pattern on the part of EPA in which they were very 
proactively implementing the changes in the formaldehyde. And 
what we see is, once these are all fully implemented, we 
believe that the quality of the assessments will actually 
improve dramatically.
    Ms. Clark. Thank you.
    Mr. Walls, in your testimony you talked--referred a few 
times to timely manner of these assessments. Do you believe the 
IRIS program is completing assessments in a timely manner?
    Mr. Walls. Congresswoman Clark, I think our view would be 
that IRIS can do a better job, and, if it systemically 
implements the recommendations made by the NAS, for example, 
can get to a steady state stage, where they can regularly and 
confidently produce these assessments.
    Ms. Clark. Would the industry support additional resources 
to make this happen for IRIS?
    Mr. Walls. We have made clear our support for the agency 
having appropriate resources to do this work.
    Ms. Clark. Thank you.
    Chairman Broun. Thank you, Ms. Clark.
    Mr. Swalwell, you are recognized for three minutes. And 
please be quick, because I would like to get to Ms. Edwards, if 
we can, before--and give her a chance too. So you are 
recognized for----
    Mr. Swalwell. I will, and I have just one question for 
Professor Steinzor, and I am a former University of Maryland 
School of Law student, so I am thrilled----
    Ms. Steinzor. Fantastic.
    Mr. Swalwell. --you are there. Professor Steinzor, you 
acknowledged in your testimony that the science of risk is 
always evolving, yet the Academies have suggested, in their 
recent report, that EPA adopt firm stopping rules for key 
points in the IRIS process. Although it may appear obvious to 
most, could you elaborate on the need for EPA to incorporate 
stopping rules into the IRIS process, and how would a lack of 
stopping rules impact the IRIS process?
    Ms. Steinzor. So a stopping rule would be, we are going to 
look at this information that is available as of this point. We 
are going to apply a weight of the evidence analysis to it. We 
are going to write an IRIS profile, and then we are going to 
put the profile out. And if there are subsequent studies, we 
will take a look at those, and revise the profile as 
appropriate, on a cycle of five years, as an example, which is 
what applies to national ambient air quality standards, and it 
has worked fairly well.
    Mr. Swalwell. Thank you. Go Terps, and I yield back the 
balance of my time.
    Ms. Steinzor. Fear the Turtle.
    Dr. Olden. May I add to that? We have, in fact, developed 
firm stopping rules in our enhancements that we rolled out 
about last summer, in July. There are firm stopping rules 
today.
    Thank you.
    Chairman Broun. Very good. Thank you, Dr. Olden. Ms. 
Edwards, you are recognized for a very quick three minutes, 
please, ma'am.
    Ms. Edwards. Thank you very much, Mr. Chairman, and I will 
be quick. My question is for Mr. Walls. You represent the 
American Chemical Council. Is it true that the council spent 
about $2.9 million in lobbying expenses over this last year, in 
2014?
    Mr. Walls. I would assume that is correct.
    Ms. Edwards. And then in 2013 you spent about $13 million 
in lobbying expenses?
    Mr. Walls. I don't have those figures in front of me, but 
we do make lobbying expenditures, yes, ma'am.
    Ms. Edwards. And I just want to be clear. So my 
understanding is that the council has opposed the assessment 
for formaldehyde, opposed the assessment coming forward for 
arsenic, opposed the assessment coming forward for 
trichloroethylene, TCE, that is present in our drinking water. 
Is there an assessment that you all support the EPA moving 
forward on?
    Mr. Walls. Congresswoman, our interest is ensure that the 
best, highest quality, most reliable science is brought forward 
to make those decisions.
    Ms. Edwards. Right. What is the----
    Mr. Walls. The regulatory----
    Ms. Edwards. --last assessment that you--what is the last 
assessment that you supported the EPA moving forward on?
    Mr. Walls. We----
    Ms. Edwards. Give me one.
    Mr. Walls. We give--we support a number of assessments. 
There is--EPA, for example, has a work plan chemical assessment 
program in the Office of Pollution Prevention and Toxics, and 
we have been clear that we support the agency's moving forward.
    Ms. Edwards. Have you supported the agency moving forward 
on the arsenic assessment?
    Mr. Walls. Congresswoman, we have made clear that our 
interest is in----
    Ms. Edwards. Have you supported the EPA moving forward----
    Mr. Walls. To date----
    Ms. Edwards. --on the arsenic assessment?
    Mr. Walls. We support moving forward on assessments in a 
way that is----
    Ms. Edwards. Have you supported the EPA moving forward on 
the arsenic assessment?
    Mr. Walls. I----
    Ms. Edwards. Have you supported the EPA moving forward on 
the formaldehyde assessment?
    Mr. Walls. We have supported the agency moving forward on 
IRIS assessments, but to do so in a manner that----
    Ms. Edwards. Have you--I just want a yes or no, if you 
could. Have you supported the----
    Mr. Walls. I can't----
    Ms. Edwards. --EPA moving----
    Mr. Walls. I can't----
    Ms. Edwards. --forward on the----
    Mr. Walls. --a yes or no----
    Ms. Edwards. --formaldehyde assessment?
    Mr. Walls. --Congresswoman.
    Ms. Edwards. No?
    Mr. Walls. We have supported moving forward on the 
assessment in a way----
    Ms. Edwards. On the formaldehyde assessment?
    Mr. Walls. In a way that----
    Ms. Edwards. Support----
    Mr. Walls. --reflects the----
    Ms. Edwards. --the EPA----
    Mr. Walls. --recommendations made----
    Ms. Edwards. --moving forward on the----
    Mr. Walls. --by the----
    Ms. Edwards. --formaldehyde assessment? Did you--did the 
American Chemistry Council have anything at all to do, or spend 
any lobbying expenses, on ensuring that the EPA could not move 
forward, and this Congress could not move forward, on the 
arsenic assessment? Did you all lobby on that issue at all----
    Mr. Walls. I----
    Ms. Edwards. --in the Congress?
    Mr. Walls. I don't have direct knowledge of that, but I 
assume we did, yes.
    Ms. Edwards. I will be following up with additional 
questions.
    Mr. Walls. I will look forward----
    Ms. Edwards. Thank you very----
    Mr. Walls. --to your questions.
    Ms. Edwards. --much to the witnesses.
    Chairman Broun. Thank you, Ms. Edwards. Apologize for the 
fast round of questions. We have two more minutes in this vote, 
so we are going to submit questions for the record, and you can 
answer them. You can put a lot more flesh on these. Thank you 
for your flexibility. And, again, I apologize for the hasty 
period of time. I thank Members for you all's flexibility. The 
record will remain open for two weeks for additional comments 
and written questions from Members. The witnesses are now 
excused. This hearing is adjourned, and thank you all.
    [Whereupon, at 2:27 p.m., the Subcommittees were 
adjourned.]
                               Appendix I

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                   Answers to Post-Hearing Questions


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


                              Appendix II

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                   Additional Material for the Record

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


          Prepared Statement of Full Committeee Ranking Member
                         Eddie Bernice Johnson

    Thank you Mr. Chairman. Virtually every aspect of our daily lives 
is impacted by the use and presence of chemicals. The goal of the 
Integrated Risk Information System (IRIS) at EPA is to provide 
information to the American people about the risks associated with 
exposure to certain chemicals. It should be obvious to anyone that 
information about the health effects of chemical exposures can only 
benefit the public. Unfortunately, the value of IRIS is too often 
obscured by the criticisms of those who stand to gain by interfering 
with EPA's mission to protect human health and the environment.
    The National Academies report released this May praises the 
substantial improvement made by EPA in addressing issues that had been 
raised about the IRIS process. Specifically, the report states that if 
EPA continues on this path of improvement, ``the IRIS process will 
become much more effective and efficient in achieving its basic goal of 
developing human-health assessments that can provide the scientific 
foundation for ensuring that risks posed to public health by chemicals 
are assessed and managed properly.'' The report also points out two 
important future steps which EPA can take to further improve the 
quality of their IRIS assessments.
    First, EPA must continue to expand opportunities for stakeholder 
input and discussion. The chemical industry is not the only stakeholder 
in public health assessments. Community groups and public health 
organizations do not always have the same resources to support 
meaningful participation in the public processes of IRIS. The EPA must 
not permit a privileged few to monopolize a process meant to foster 
open discussion.
    Second, EPA should be diligent in developing firm ``stopping 
rules,'' that guard against undue delay in releasing its assessments. 
Hundreds of new chemicals are released onto the market every year with 
no requirement that their safety be demonstrated. IRIS was created to 
address this lack of information on the potential toxicity of these 
chemicals and their influence on human health.
    Unfortunately, the pace at which IRIS finalizes its assessments has 
slowed to an unacceptable rate. It is time EPA moves ahead with urgency 
to bridge this gap and fulfill its mission. I am looking forward to 
hearing from Dr. Olden on this matter.
    It is clear that IRIS provides a valuable service to the American 
people. We must encourage EPA to be diligent in its efforts for 
continued improvement, and support them as they implement the 
recommendations of the National Academies.
    Thank you, and I yield back.

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