[House Hearing, 115 Congress]
[From the U.S. Government Publishing Office]


                        EXAMINING THE SCIENTIFIC
                      AND OPERATIONAL INTEGRITY OF
                           EPA'S IRIS PROGRAM

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

                             JOINT HEARING

                               BEFORE THE

                     SUBCOMMITTEE ON ENVIRONMENT &
                       SUBCOMMITTEE ON OVERSIGHT

              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED FIFTEENTH CONGRESS

                             FIRST SESSION

                               __________

                           SEPTEMBER 6, 2017

                               __________

                           Serial No. 115-26

                               __________

 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
FRANK D. LUCAS, Oklahoma             EDDIE BERNICE JOHNSON, Texas
DANA ROHRABACHER, California         ZOE LOFGREN, California
MO BROOKS, Alabama                   DANIEL LIPINSKI, Illinois
RANDY HULTGREN, Illinois             SUZANNE BONAMICI, Oregon
BILL POSEY, Florida                  AMI BERA, California
THOMAS MASSIE, Kentucky              ELIZABETH H. ESTY, Connecticut
JIM BRIDENSTINE, Oklahoma            MARC A. VEASEY, Texas
RANDY K. WEBER, Texas                DONALD S. BEYER, JR., Virginia
STEPHEN KNIGHT, California           JACKY ROSEN, Nevada
BRIAN BABIN, Texas                   JERRY MCNERNEY, California
BARBARA COMSTOCK, Virginia           ED PERLMUTTER, Colorado
BARRY LOUDERMILK, Georgia            PAUL TONKO, New York
RALPH LEE ABRAHAM, Louisiana         BILL FOSTER, Illinois
DRAIN LaHOOD, Illinois               MARK TAKANO, California
DANIEL WEBSTER, Florida              COLLEEN HANABUSA, Hawaii
JIM BANKS, Indiana                   CHARLIE CRIST, Florida
ANDY BIGGS, Arizona
ROGER W. MARSHALL, Kansas
NEAL P. DUNN, Florida
CLAY HIGGINS, Louisiana
RALPH NORMAN, South Carolina
                                 ------                                

                      Subcommittee on Environment

                    HON. ANDY BIGGS, Arizona, Chair
DANA ROHRABACHER, California         SUZANNE BONAMICI, Oregon, Ranking 
BILL POSEY, Florida                      Member
MO BROOKS, Alabama                   COLLEEN HANABUSA, Hawaii
RANDY K. WEBER, Texas                CHARLIE CRIST, Florida
BRIAN BABIN, Texas                   EDDIE BERNICE JOHNSON, Texas
BARRY LOUDERMILK, Georgia
JIM BANKS, Indiana
CLAY HIGGINS, Louisiana
RALPH NORMAN, South Carolina
LAMAR S. SMITH, Texas
                                 ------                                

                       Subcommittee on Oversight

                   HON. DRAIN LaHOOD, Illinois, Chair
BILL POSEY, Florida                  DONALD S. BEYER, Jr., Virginia, 
THOMAS MASSIE, Kentucky                  Ranking Member
BARRY LOUDERMILK, Georgia            JERRY MCNERNEY, California
ROGER W. MARSHALL, Kansas            ED PERLMUTTER, Colorado
CLAY HIGGINS, Louisiana              EDDIE BERNICE JOHNSON, Texas
RALPH NORMAN, South Carolina
LAMAR S. SMITH, Texas
                            C O N T E N T S

                           September 6, 2017

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

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

                           Opening Statements

Statement by Representative Andy Biggs, Chairman, Subcommittee on 
  Environment, Committee on Science, Space, and Technology, U.S. 
  House of Representatives.......................................     4
    Written Statement............................................      

Statement by Representative Suzanne Bonamic, Ranking Member, 
  Subcommittee on Environment, Committee on Science, Space, and 
  Technology, U.S. House of Representatives......................     8
    Written Statement............................................    10

Statement by Representative Darin LaHood, Chairman, Subcommittee 
  on Oversight, Committee on Science, Space, and Technology, U.S. 
  House of Representatives.......................................    12
    Written Statement............................................    14

Statement by Representative Donald Beyer, Ranking Member, 
  Subcommittee on Oversight, Committee on Science, Space, and 
  Technology, U.S. House of Representatives......................    15
    Written Statement............................................    17

Statement by Representative Eddie Bernice Johnson, Ranking 
  Member, Committee on Science, Space, and Technology, U.S. House 
  of Representatives.............................................    19
    Written Statement............................................    21

                               Witnesses:

Dr. Kenneth Mundt, Principal, Ramboll Environ
    Oral Statement...............................................    23
    Written Statement............................................    26

Dr. James Bus, Senior Managing Scientist, Exponent
    Oral Statement...............................................    44
    Written Statement............................................    46

Dr. Thomas Burke, Professor, Bloomberg School of Public Health, 
  Johns Hopkins
    Oral Statement...............................................    50
    Written Statement............................................    52

Discussion.......................................................    60

             Appendix I: Answers to Post-Hearing Questions

Dr. Kenneth Mundt, Principal, Ramboll Environ....................    80

Dr. James Bus, Senior Managing Scientist, Exponent...............   110

Dr. Thomas Burke, Professor, Bloomberg School of Public Health, 
  Johns Hopkins..................................................   112

            Appendix II: Additional Material for the Record

Documents submitted by Representative Andy Biggs, Chairman, 
  Subcommittee on Environment, Committee on Science, Space, and 
  Technology, U.S. House of Representatives......................   116

Documents submitted by Representative Suzanne Bonamic, Ranking 
  Member, Subcommittee on Environment, Committee on Science, 
  Space, and Technology, U.S. House of Representatives...........   121

 
                        EXAMINING THE SCIENTIFIC
                       AND OPERATIONAL INTEGRITY
                         OF EPA'S IRIS PROGRAM

                              ----------                              


                      Wednesday, September 6, 2017

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

    The Subcommittees met, pursuant to call, at 10:04 a.m., in 
Room 2318 of the Rayburn House Office Building, Hon. Andy Biggs 
[Chairman of the Subcommittee on Environment] presiding.
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    Chairman Biggs. Good morning. Welcome to the Subcommittee 
on Environment and Oversight in the House Committee on Science, 
Space, and Technology, our hearing on ``Examining the 
Scientific and Operational Integrity of the EPA's IRIS 
Program.''
    I'm grateful to be back. Good to see so many back, and I 
know others will be coming, and I hope all of you had a 
productive work period in your districts.
    The Subcommittee on Environment and Oversight will come to 
order. Without objection, the Chair is authorized to declare 
recesses of the Subcommittee at any time.
    Welcome to today's hearing titled ``Examining the 
Scientific and Operational Integrity of EPA's IRIS Program.'' I 
recognize myself for five minutes for an opening statement.
    Welcome to our Subcommittee hearing titled ``Examining the 
Scientific and Operational Integrity of EPA's IRIS Program.'' 
Today, we will hear from witnesses who are experts in the 
fields of epidemiology and toxicology and learn about their 
interactions with EPA's IRIS program. The original purpose of 
IRIS was simply to identify and characterize the health hazards 
of chemicals that are found in the environment. However, this 
program has long suffered from a lack of scientific 
transparency and an inability to produce work in a timely 
manner.
    Even worse, IRIS appears to have been used by the previous 
Administration as cover for unjustified and unscientific 
regulatory action, something well outside of the scope of the 
program's mandate.
    I'm far from the only one raising the alarm. In fact, both 
the National Academy of Science and the Government 
Accountability Office have been critical of the management of 
the IRIS program.
    In February of this year, GAO again included IRIS on its 
annual high-risk list, which identifies federal programs that 
have greater than normal vulnerabilities to fraud, waste, 
abuse, and mismanagement.
    In both 2011 and 2014, NAS made numerous recommendations 
for IRIS that have never been fully implemented. For example, 
NAS found that IRIS assessment methods and reporting continue 
to be a concern, especially in light of the extremely long 
process that IRIS takes to choose chemicals and complete its 
evaluations.
    Despite the numerous deficiencies that were highlighted in 
both the GAO and NAS reports, IRIS fails to show any sign of 
improvement. It is now the role of Congress, as the ultimate 
steward of taxpayer dollars, to carefully assess whether IRIS 
can even be salvaged. I myself remain very skeptical and simply 
cannot support the program in its current form.
    What I find most troubling is that IRIS may be providing 
conflicting or duplicative information and creating confusion 
for Americans regarding either the harm or lack of harm that 
any given chemical may possess. If that is indeed the case, 
IRIS poses a threat to the public's trust and safety and simply 
cannot be allowed to continue to operate.
    I'm also deeply concerned by the fact that we can actually 
point to cases in which determinations by IRIS have been 
inappropriately used to make regulatory decisions. For example, 
the previous Administration took action against a chemical 
manufacturer in Louisiana based on a faulty IRIS determination, 
even though that particular company was currently in compliance 
with all emissions regulations put forward under the Clean Air 
Act. Actions like the one initiated by IRIS in Louisiana do not 
inspire confidence in our federal agencies.
    This Committee is committed to ensuring that EPA uses the 
best available science. IRIS, it appears, has failed to use 
even passable science on many occasions, and what is so 
troubling is that even when IRIS administrators are alerted to 
this fundamental problem, they take absolutely no corrective 
action.
    We must also be committed to ensuring that EPA's actions 
are based on the highest levels of scientific integrity. The 
fact that IRIS has been subjected to continued scrutiny of its 
scientific processes and continued requests for Information 
Quality Act reviews should send a clear signal that the program 
is failing and is in serious danger of irrevocably subverting 
its mission.
    All those concerns aside--and they are considerable--I am 
hopeful that the witnesses before us today can provide Congress 
with information to better inform actions that this Committee 
may take. We all want to ensure the protection of American 
citizens from the potentially harmful impacts of chemicals. If 
IRIS is the appropriate program to do that, we in Congress must 
ensure that it is properly organized and makes informed 
decisions.
    Moreover, we must ensure that IRIS efforts--the efforts of 
IRIS to evaluate chemicals are based on real-world threats, not 
theoretical ones.
    I would briefly take a moment to point out that the 
existence of or changes to the IRIS program would not have an 
impact on the continued effectiveness of EPA's Risk Management 
program.
    I look forward to learning more from our distinguished 
panel today, and have no doubt that this will be a wide-ranging 
and fascinating discussion. I thank each of our witnesses for 
being here today.
    [The prepared statement of Chairman Biggs follows:]
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    Chairman Biggs. And with that, I yield back the balance of 
my time and recognize now the Ranking Member of the Environment 
Subcommittee, the gentlewoman from Oregon, for an opening 
statement.
    Mr. Bonamici. Thank you very much, Mr. Chairman.
    Mr. Chairman, this Committee has a long tradition of 
examining the Environmental Protection Agency's Integrated Risk 
Information System, or IRIS. The last time this Committee held 
a hearing on it was back in 2014, and at that hearing, I said 
that this Committee needs to allow the EPA to fulfill its 
mission of protecting the public's health from environmental 
hazards. Producing assessments of chemicals that may cause harm 
to our constituents and our communities is critical to that 
mission.
    I am disappointed that today, this Committee is once again 
headed in the wrong direction. Rather than undermining 
important public health assessments, we should be supporting 
and in fact strengthening the EPA's efforts to protect 
Americans from unsafe chemical exposure. Given that the 
Committee has not held a hearing on this issue in three years, 
it is troubling that today the Majority is calling two 
witnesses with clear interests in a particular outcome, but did 
not call the EPA or the GAO. This does not seem to me like a 
hearing to investigate how we can best protect our 
constituents' health, which is what we should be doing, but 
instead an attempt to look for a basis for weakening or 
eliminating the IRIS program. That is unacceptable.
    It's also perplexing that the Majority is hosting a hearing 
to emphasize industry-held criticisms of the IRIS program at a 
time when independent organizations that have investigated the 
IRIS program are citing its notable improvements. And Mr. 
Chairman, you said that IRIS has failed to show any signs of 
improvement, but just last week, the independent EPA Science 
Advisory Board, or the SAB, wrote a letter to Administrator 
Pruitt praising the progress of the IRIS program. That letter 
said, ``The SAB has observed significant enhancements in the 
IRIS program over the last few years, with impactful changes 
over the past year, and marked progress over the past six 
months. The changes are so extensive and positive that they 
constitute a virtual reinvention of IRIS,'' and I'll repeat 
that last line: ``The changes are so extensive and positive 
that they constitute a virtual reinvention of IRIS.''
    The work of IRIS is especially critical to protecting the 
health of our Nation's children. The human health assessments 
developed through the program provide vital information that 
aids the EPA in its decision making, and also informs state and 
local governments and public health professionals. 
Fundamentally the IRIS program helps those tasked with 
protecting the public's health to make the best decisions they 
can by using the best available science to determine the 
potential harmful effects of chemical exposures. That is 
precisely why this Committee has taken an interest in the 
activities of IRIS in the past, particularly when the program 
was not living up to its potential.
    In response to a request from Congress, the National 
Academies reviewed the IRIS program and released a report, two 
months prior to our 2014 hearing, which made recommendations 
for improvements that EPA should implement. What is the status 
of those recommendations, what progress has the program made, 
and what improvements are still needed? Those are the questions 
we should be asking the EPA and the National Academies. 
Unfortunately, the Majority did not invite anyone from the EPA 
or the National Academies to offer any answers.
    Mr. Chairman, the IRIS program is too important for there 
not to be a thoughtful examination of its status and a fuller 
review of the recent progress it has made. This Committee has 
the important role of providing oversight of the 
Administration's efforts in its jurisdiction.
    During the Obama Administration, this Committee held dozens 
and dozens of hearings investigating actions of the 
Administration, and the EPA, including the EPA Administrator, 
was here to answer. Yet, now that there is a Republican 
Administration, this Committee has failed to have a single 
hearing with any of the presidential appointments in its 
jurisdiction.
    During the Obama Administration, Administrator Pruitt 
testified in front of this Committee in his role as Oklahoma's 
Attorney General and was highly critical of the EPA. Now that 
he is the EPA Administrator, the American people deserve the 
opportunity to hear his priorities for the EPA. This Committee 
must fulfill its duty of providing oversight of the agencies in 
its jurisdiction.
    Mr. Chairman, will you commit to holding a Full Committee 
hearing on a legislative day this year with EPA Administrator 
Pruitt?
    Chairman Biggs. Is the gentlewoman done?
    Ms. Bonamici. No, I'm asking, Mr. Chairman, will you commit 
to holding a Full Committee hearing on a legislative day this 
year with EPA Administrator Pruitt? He has not been before this 
Committee yet.
    Chairman Biggs. Well, I appreciate you asking me a question 
in public that you've never broached with me in private, which 
I consider to be highly improper and highly unusual, frankly, 
and I'm happy to discuss with you in private.
    Ms. Bonamici. Thank you, Mr. Chairman.
    And finally, Mr. Chairman, I ask that the letter from EPA's 
Science Advisory Board, which I referenced earlier, be made a 
part of the record.
    Thank you, and I yield back.
    [The prepared statement of Ms. Bonamici follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Biggs. Thank you, Ms. Bonamici. Thank you.
    And now we're going to recognize the Chairman of the 
Subcommittee on Oversight, Mr. LaHood, for his opening 
statement.
    Mr. LaHood. Thank you, Chairman Biggs, and good morning, 
and welcome to today's Joint Subcommittee hearing on 
``Examining EPA's Integrated Risk Information System Program.''
    Today, we will hear from expert witnesses highlighting 
various examples of why oversight of the IRIS program is 
critical to restoring scientific integrity to the agency. I 
would like to thank the witnesses in advance for their 
testimony today.
    EPA created IRIS in 1985 under no statutory authority, 
defining no safeguards, timelines, or binding requirements with 
which the program must adhere. EPA intended for the program to 
``foster consistency in the evaluation of chemical toxicity 
across the Agency.''
    However, since 2011 multiple reports have been issued 
raising glaring deficiencies in the program that to this day 
have gone unaddressed. As we will hear today from witnesses, 
there are many questions and issues that have been raised about 
IRIS assessments being based on sound science. There are 
multiple instances of the IRIS program relying on outdated or 
flawed studies to complete assessments, neglecting to obtain or 
use the scientifically critical raw supporting data related to 
risk assessments. Moreover, IRIS has failed to adapt mode-of-
action science utilized by other offices within EPA, which we 
will hear today from Dr. Bus.
    More troubling, it appears that quasi-regulatory decisions 
have been based off the assessments completed by the IRIS 
program. The fact that many of these assessments may be faulty 
illustrates why oversight is so important to the function of 
our government.
    An accredited scientific body, The National Academy of 
Sciences, has raised serious questions and concerns about IRIS. 
The GAO has included IRIS on its biennial High Risk List since 
2009, and this Committee sent EPA a letter last year raising 
similar concerns. These combined efforts have resulted in 
little, if any, improvement to the IRIS program. By holding 
this hearing today and diving deeper into the issue at hand, I 
hope to continue an oversight of the IRIS program to bring 
attention to the scientific integrity issues that need to be 
addressed here today.
    And Mr. Chairman, I would also add, I know a number of 
issues have been raised already here this morning. I would just 
mention that the Minority mentioned the EPA's Science Advisory 
Board letter to Administrator Pruitt as evidence the IRIS 
program has been improved significantly. This letter was sent 
to Administrator Pruitt last Friday, September 1st, less than 
36 hours after the Science Advisory Board meeting and two days 
after the public notice of today's hearing. The Board was not 
tasked with providing official review or comment on the 
presentation highlighting changes to the IRIS program. It 
appears that the SAB recognizes that issues have existed in the 
past with regard to the IRIS program and that issues still 
persist currently. Given the speed with which this letter was 
sent, I find it difficult for the letter to carry much weight 
toward establishing any significant progress with the IRIS 
program.
    Moreover, this letter fails to provide for any meaningful 
scientific scrutiny of reviews completed in the past where 
scientific integrity issues have been raised, which is one of 
the major issues with the program and why we are here today, 
Mr. Chairman.
    With that, I yield back. Thank you.
    [The prepared statement of Mr. LaHood follows:]
    [GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Biggs. Thank you, Mr. LaHood.
    I now recognize the Ranking Member of the Subcommittee on 
Oversight, Mr. Beyer, for his opening statement.
    Mr. Beyer. Thank you, Chairman Biggs, and thank you, 
Chairman Biggs and Chairman LaHood, for this hearing.
    And I too must convey my disappointment with this hearing 
and the apparent purpose. I'm encouraged by my friend Chairman 
LaHood's comments that he believes it's the appropriate role 
for this Committee to have oversight of IRIS but this--I fear 
this isn't a hearing about oversight. This is going to be a 
hearing about how to--not a hearing about how to improve the 
critical function of the EPA's Integrated Risk Information 
System, not a hearing to actually determine the facts about the 
remarkable progress they've recently made. This appears to be a 
hearing for industry.
    The letter that the EPA's Science Advisory Board wrote to 
EPA Administrator Pruitt last week touted the progress made by 
the IRIS program and its importance in protecting the public 
health. To quote: ``The SAB members in attendance voted 
unanimously that I communicate to you their enthusiasm for the 
IRIS program's progress.'' However, the Majority has not 
invited anyone from the SAB or the National Academies of 
Sciences or the GAO or the EPA to testify about the significant 
improvements the program has made. And I don't think that it 
undercuts the validity or the importance of the SAB's letter to 
suggest that it was at least partially a reaction to the 
announcement of this hearing. Of course it was. When they saw 
this was coming up, they thought it was important to note all 
the progress that had been made.
    The Majority has instead chosen to ignore this progress and 
invite two industry scientists as witnesses, who undoubtedly 
criticize the IRIS program and the EPA in general, and despite 
assurances from Majority staff that this hearing is simply 
about hearing from stakeholders, the real intent seems to 
coincide with a call by industry to eliminate IRIS altogether. 
For example, if I could ask one slide to be put up? I note that 
our Chairman Biggs recently offered an amendment to H.A. 3354, 
the Appropriations Act of 2018, that would zero out all funding 
for EPA's IRIS program, effectively abolishing it.
    I believe this hearing should be viewed in the larger 
context of what it actually is, which is another attack on the 
American public's environmental health, another opportunity for 
industry consultants and industry-paid scientists to attempt to 
weakness the effectiveness of the EPA, the only federal agency 
charged with protecting the environment and the health of the 
American people.
    You know, whatever efforts this Administration takes to 
impede progress made to the EPA's IRIS program, reduce its role 
in identifying harmful chemicals, or eliminate this program 
altogether, those efforts unfortunately fit neatly into the 
anti-science agenda already unveiled by this Administration. 
Since the Trump Administration came to office less than eight 
months ago, political appointees at EPA are now reviewing 
grants to conduct scientific studies, rather than actual 
scientists as has been the tradition through Democratic and 
Republican Presidents in the past. The EPA has withdrawn a data 
request to industry regarding methane emissions from the oil 
and gas industry, which is a growing and dangerous problem. 
Administrator Scott Pruitt has made it known he wants more 
industry representatives on the Agency's scientific advisory 
boards, an effort that will undermine the health and safety of 
the American public and damage the environment. Key positions 
at the EPA are now being filled with individuals with deep ties 
to industry, rather than qualified scientists or qualified 
public health experts. Senior federal officials and scientists 
have resigned in protest over the direction of the Trump 
Administration and the actions of the EPA Administrator, and 
the EPA and other federal agencies have scrubbed references to 
climate change from their websites and some federal offices 
have reportedly banned the use of the term.
    So it really disheartens me that the Science Committee is 
not investigating important scientific issues that have a real 
world impact on the health and safety of our citizens across 
the country, their exposure to chemical pollutants, and the 
human health implications of a warming climate. Rather, the 
Committee seems resolved to providing a forum for industry 
scientists to advocate for policies and procedures that will 
please the industries they work for, but cause harm to the 
environment and the public health of all Americans across the 
political spectrum.
    Thank you, Mr. Chairman. I yield back.
    [The prepared statement of Mr. Beyer follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Biggs. Thank you, Mr. Beyer.
    I now recognize the Ranking Member of the Full Committee, 
Ms. Johnson.
    Ms. Johnson. Thank you very much, Mr. Chairman.
    I too must say that I'm disappointed, but I'm really not 
surprised that we are holding this hearing today. Sadly, I have 
had to make this statement too many times in the last four 
years.
    How can we, in good conscience, title this hearing as an 
examination of the scientific and operational integrity of 
EPA's IRIS program, when there is no one here from EPA here to 
testify? I don't think we can. How do we conduct the necessary 
oversight for this program when the Government Accountability 
Office is not present to answer questions about their recent 
review of IRIS? I don't know that we can. How are we serving 
the best interests of our constituents, and of all Americans, 
when the National Academies of Sciences is not present to 
discuss their report upon which the last three years. worth of 
reforms to IRIS were based upon? I don't think we are. How can 
we have an honest discussion about this program while ignoring 
the key entities that have reviewed it and studied its recent 
improvements? I don't think we can.
    I would also note that just last week the EPA's independent 
Science Advisory Board--the SAB--sent a letter to EPA 
Administrator Scott Pruitt praising the progress the IRIS 
program has made. The letter said, in part, and I quote: ``The 
Board commends the Agency for making such significant 
improvements over a short period of time. We are optimistic 
that the restructured IRIS program will strengthen the 
scientific foundations of risk assessment and protect the 
health and safety of the American public.'' But we are not here 
to hear that today. Instead, the Majority has invited two 
industry scientists to voice their criticisms of IRIS.
    Let me be clear, industry perspectives should not be 
excluded from scientific discussions on environmental issues at 
the EPA, and they are not now and nor have they ever been. The 
current membership of EPA's Science Advisory Board, for 
instance, includes representatives from the Dow Chemical 
Company, Procter and Gamble, and Exxon Mobil. However, I'm 
concerned that industry, the leadership of this Committee, and 
now this Administration, are seeking to let industry drive the 
science upon which critical decisions about protecting the 
public's health and the environment are made.
    The current criticisms of the EPA's IRIS program by 
industry highlight that point. We have seen this tactic used by 
industry before, and I'm sure that we'll see it repeated in the 
future.
    Mr. Chairman, not only can we do better, we must do better. 
The American people deserve a Congress that is working for 
them, and with them, not against them, and certainly not for 
the interests of wealthy polluting industries. I hope that one 
day soon our Committee will be a forum for a balanced 
discussion on the critical issues under our jurisdiction. 
Unfortunately, today's hearing falls well short of that mark.
    My last point--the response from the Majority to my 
statement may be that Minority Members are permitted to invite 
one witness to these hearings and that we could have invited 
anyone we wanted to, such as a representative of the EPA, the 
SAB or the GAO or the National Academies. My response to that, 
Mr. Chairman is that I don't believe it is the job of the 
Minority to do the Majority's job for them. It is clear that 
all of those entities should be represented at today's hearing, 
not just the single witness allocated for the Minority. If we 
are serious about conducting credible oversight of IRIS, I 
would hope that the Majority will commit to a follow-up hearing 
so that those voices may be heard.
    I thank you, and I yield back.
    [The prepared statement of Ms. Johnson follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Biggs. Thank you. I thank the gentlewoman.
    I want to now introduce our witnesses, the three with 
impeccable scientific backgrounds and expertise, and I'm 
grateful that each of you would take time to be here today. 
When you give your testimony, at some points you'll get five 
minutes, and I'll stand up and dance as you get close so you 
know you're near the end.
    Dr. Kenneth Mundt is our first witness. He is the Principal 
at Ramboll Environ, where he serves as the Health Sciences 
Global Practice Area Leader and Director of Applied 
Epidemiology. Additionally, Dr. Mundt is an Adjunct Faculty 
Member at the University of North Carolina and the University 
of Massachusetts-Amherst. He received a bachelor's degree from 
Dartmouth College and a Ph.D. in epidemiology from the 
University of North Carolina at Chapel Hill.
    Our next witness today is Dr. James Bus, Senior Managing 
Scientist at Exponent. Dr. Bus has over 23 years' experience as 
a Consulting Toxicologist in the Toxicology and Environmental 
Research and Consulting Unit at the Dow Chemical Company and 
serves as an Adjunct Professor in the Department of 
Pharmacology and Toxicology at Michigan State University. He 
received a bachelor's degree in medicinal chemistry and a Ph.D. 
in pharmacology from Michigan State University.
    And our final witness today is Dr. Thomas Burke, Professor 
at Johns Hopkins Bloomberg School of Public Health. Dr. Burke 
also serves as the Director of the Johns Hopkins Risk Sciences 
and Public Policy Institute. He received a master's of public 
health from the University of Texas and a Ph.D. from the 
University of Pennsylvania.
    And I now recognize Dr. Mundt for five minutes to present 
his testimony. Dr. Mundt.

                TESTIMONY OF DR. KENNETH MUNDT,

                   PRINCIPAL, RAMBOLL ENVIRON

    Dr. Mundt. Good morning.
    Chairman Biggs. You're going to need to press the ``talk'' 
button. There you go. Thanks.
    Dr. Mundt. Good morning. Thank you, Mr. Chairman. My name 
is Kenneth Mundt. I'm an Epidemiologist and Health Sciences 
Practice Network Leader at Ramboll Environ.
    My career has focused on evaluating health risks of 
chemicals, particularly in the workplace. Thank you and the 
Committees for the opportunity today to provide the highlights 
of a scientific evaluation of the 2010 IRIS Toxicological 
Review of Chloroprene that colleagues at Ramboll and Environ 
and I recently completed. Our evaluation of the IRIS review 
illustrates how important good science is to understanding 
human health risks and highlights some issues that need to be 
addressed.
    IRIS is responsible for evaluating the potential human 
health effects of chemical exposures. However, as noted, the 
IRIS review process has been criticized by expert panels of the 
National Research Council of the National Academy of Sciences. 
In particular, the NAS emphasized the importance of 
transparency and rigor in the IRIS review methods. Our 
evaluation of the IRIS review of chloroprene identified several 
scientific problems impacting the evaluation of chloroprene as 
a human carcinogen, and leading to the derivation of an 
inhalation unit risk, or IUR, that is 156 times greater than 
the IUR we derived.
    The following were among the key scientific problems we 
found with that IRIS review. First, EPA failed to critically 
evaluate the quality of each epidemiological study of 
chloroprene-exposed workers, which resulted in giving equal 
weight to all studies, both good and bad. Suggestive positive 
associations were reported among the weakest studies with the 
greatest limitations. However, the largest and best study 
demonstrated no increased risk of liver or lung cancers. The 
NAS reviews provided guidance on study selection, methods for 
evaluating study quality, accounting for various forms of bias 
that impact study findings, and integrating evidence so that 
stronger studies are given greater weight.
    Second, the EPA ignored the strongest study's conclusion: 
``Persons exposed to chloroprene or vinyl chloride at the 
levels encountered in the four study sites did not have 
elevated risk of mortality from any of the causes of death 
including all cancers combined and lung and liver cancers, the 
cancer sites of a priori interest.'' In contrast, the IRIS 
review noted ``Relative risk estimates for liver cancer while 
not statistically significant increased with increasing 
exposure indicating a dose response trend.'' However, this 
trend also was not statistically significant and provides no 
evidence of increased risk.
    Third, and most importantly, EPA did not fully account for 
large and well-recognized differences between mice and humans. 
Mice appear to be far more sensitive to chloroprene than other 
animals, or even humans, which can be explained by differences 
in pharmacokinetics. Accounting for these differences using 
standard methods applied by EPA and IRIS reviews of other 
chemicals dramatically reduced the estimated IUR.
    Ultimately, applying standard EPA methodology and 
conservative assumptions we derived the revised IUR. Compared 
with ours, the EPA IUR was 156 times higher. Simply put, the 
EPA's IUR is extremely large, scientifically implausible, and 
has significant real-world consequences. Correction of the IUR 
is especially critically given that it has prompted lawsuits 
and enforcement actions.
    Our critical review and integration of the published 
epidemiological and toxicological evidence on chloroprene also 
highlights the need to reconsider EPA's classification of 
chloroprene. The IRIS review classified chloroprene as ``likely 
to be carcinogenic to humans'' based on five stated criteria. 
We determined that three of these criteria are not supported by 
a weight of evidence analysis, and a fourth, the structural 
similarities to other chemicals was not informative. It also 
underscores the importance of some of the improvement 
recommended by the NAS.
    As the Committee looks at how EPA can be expending 
resources more efficiently and how to improve the IRIS program 
as a whole, the chloroprene example may help identify specific 
areas where scientific and procedural flaws may be targeted and 
remedied.
    There's nothing that precludes the EPA from using credible 
outside scientific resources to foster constructive scientific 
debate and enhance their evaluation and decision-making 
capabilities. In doing so, EPA will better achieve justifiable 
scientific conclusions.
    Thank you.
    [The prepared statement of Dr. Mundt follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Biggs. Thank you, Dr. Mundt.
    And now I recognize Dr. Bus for five minutes to present his 
testimony.

                  TESTIMONY OF DR. JAMES BUS,

              SENIOR MANAGING SCIENTIST, EXPONENT

    Dr. Bus. Good morning. I am Dr. James Bus, and I'm a 
Toxicologist with the consulting firm Exponent. I will preface 
my comments by noting that the increasingly financially and 
other resource-constrained realities confronting our nation 
demands nothing less than a cost-effective, transparent and 
science-based evaluation and regulation of environmental 
chemicals.
    I will briefly highlight three major areas of concern with 
the IRIS program. First, IRIS has not effectively implemented 
the National Academy of Sciences recommendation that good risk 
assessment must start with good problem formulation. Second, 
IRIS use of chemical mode of action information to better 
inform its risk assessments is substantially flawed. And third, 
IRIS frequently does not effectively differentiate between the 
highest quality science and that of substantially lower quality 
in its evaluations.
    The National Academy has emphasized the importance of the 
question--what problems are we trying to solve?--as an absolute 
necessity for focusing the priorities of the IRIS program. 
Although IRIS has recently implemented problem formulation 
dialog with the public, the IRIS program has not effectively 
integrated this key concept into its overall prioritization 
processes. For example, human exposures to many, if not most 
chemicals, have been substantially reduced or constrained over 
the last several decades as a direct result of regulatory and/
or industry product stewardship interventions, yet IRIS often 
overlooks this important progress as a screening mechanism to 
rule out the need for detailed evaluations. As is commonly said 
in the practice of toxicology, it is the dose that makes the 
poison. Thus, more realistic consideration of the relationships 
of human exposures to doses producing toxicity at much higher 
doses used in experimental toxicity studies must become a key 
consideration to answering the practical question of: do real-
world exposures indicate a reasonable need for a detailed risk 
assessment evaluation?
    Turning to the second point of concern, and speaking as a 
toxicologist, extensive taxpayer investments into the 
toxicological sciences have yielded substantial advances in 
understanding how chemicals cause toxic effects in animals and 
in humans. Such mode of action information is essential to 
establishing the human health relevance of toxicity observed in 
cell or animal-based toxicity findings. In recognition of the 
value of mode of action science, the toxicology, risk 
assessment, and regulatory scientific communities have 
developed detailed frameworks for credible and transparent 
translation of these data into chemical risk assessments. While 
mode of action framework processes have long been included 
within EPA guidance procedures and are routinely and 
effectively used by the EPA's Office of Pesticides, the IRIS 
program has yet to embrace their full practice. Thus, IRIS 
assessments consistently default to risk decisions that do not 
reflect the substantial added value of mode of action science 
that has long been supported by taxpayer investments.
    Finally, the IRIS program has not implemented consistent 
criteria as have other EPA offices for appropriately waiting 
study quality as key to meaningful data integration. Too often, 
poorly conducted and/or described studies carry equal weight to 
those of far higher quality in the final risk decision. For 
example, the recent IRIS evaluation of trichloroethylene, a 
commercially important solvent, relied on published studies 
from a single university-based laboratory that were 
subsequently subject to three published error correction that 
still have not clarified the experimental findings. In 
addition, not only were the original data from these 
problematic studies not available for review by the EPA, the 
study findings also were not reproduced in two much higher-
quality studies. In the case of trichloroethylene, the EPA 
decision to rely on the lower-quality study to drive the risk 
assessment has created additional environmental remediation 
costs potentially in the hundreds of millions to even billions 
of dollars.
    Thank you for the opportunity to share my personal 
perspectives on some of the more serious concerns that continue 
to plague the IRIS program. Although the IRIS program has 
recently introduced new evaluation tools aimed at improving the 
quality of its evaluation, the IRIS program, given its past 
reluctance to embrace substantive change, will be challenged to 
efficiently and effectively evolve into a program that meets 
the expectations of delivering timely, credible and science-
based assessment of environmental chemicals.
    Thank you.
    [The prepared statement of Dr. Bus follows:]
    Chairman Biggs. Thank you, Dr. Bus.
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    And now I recognize Dr. Burke for five minutes to present 
his testimony.

           TESTIMONY OF DR. THOMAS BURKE, PROFESSOR,

        BLOOMBERG SCHOOL OF PUBLIC HEALTH, JOHNS HOPKINS

    Dr. Burke. Thank you for the opportunity to address the 
Subcommittees today. I'm Tom Burke, Professor at Johns Hopkins, 
and my views are my own. They don't reflect the university.
    First, as a former Houstonian and graduate of the 
University of Texas School of Public Health in Houston, my 
thoughts are with all those impacted by Hurricane Harvey.
    This hearing is particularly timely as Texans work to 
recover, restore drinking water and housing, and evaluate the 
risks from contaminated floodwaters.
    Before joining Johns Hopkins, I worked on the frontlines as 
an environmental and health official for the State of New 
Jersey, serving three governors. I've also served on the 
National Academy of Sciences Board on Environmental Studies and 
Toxicology, the EPA Science Advisory Board, and the Board of 
scientific Counselors. From 2015 to 2017, I served as the EPA 
Science Advisor and Deputy Assistant Administrator for Research 
and Development.
    Now, the capacity to evaluate the hazards of toxic 
chemicals is essential to protecting our public health. It's 
essential for agencies, public officials, and businesses alike 
to assure clean air and safe water, to respond to emergencies, 
and to protect our workers and communities.
    The EPA IRIS program is a cornerstone of our national 
public health capacity. IRIS is charged with the daunting task 
of synthesizing enormous amounts of scientific information to 
identify the potential for a chemical to cause adverse health 
effects. The program provides a consistent and comprehensive 
source of toxicity data, not just for agency programs but for 
the regions and state officials, business and industry, and the 
public.
    IRIS is not a regulatory program but the assessments 
provide essential scientific guidance for agency decisions. Not 
surprisingly, they're controversial. Don't like the regulation? 
Attack the science.
    There's an important distinction between the IRIS 
assessment process and the ultimate risk management decision. 
The assessments provide insights on the magnitude of risks but 
they do not tell us what level of risk is acceptable nor do 
they tell us how to manage risk. Ultimately, the regulatory 
options are the responsibility of the program offices and the 
Administrator.
    Now, there are challenges to IRIS. The demand for 
information about the safety of chemicals is constantly 
growing. One of our greatest environmental challenges is the 
lack of basic information about health effects. The 2016 
bipartisan Lautenberg Chemical Safety Act represents a great 
step forward but the key to the success will be the scientific 
capacity of EPA.
    Unfortunately, there are inherent scientific uncertainties 
in toxicology and epidemiology, as we've heard. They present 
difficult challenges to IRIS. For example, does cancer in a 
laboratory test animal mean that chemical will cause cancer in 
humans? If epidemiology studies give conflicting results, which 
one do we choose? Rigorous stakeholder and peer review is built 
into the IRIS process and it's essential for producing credible 
results and addressing uncertainties.
    Now, over the past few years there's been great progress in 
improving IRIS. As was mentioned, the 2011 formaldehyde report 
presented a roadmap to improve the process by increasing 
transparency in the review of evidence. The 2014 follow-up 
report from the National Academies noted the progress. As has 
been already stated, the GAO and the EPA Science Advisory Board 
have also made note of the enormous forward progress that the 
program has taken.
    Now, in conclusion, EPA is a science-based agency. 
Ultimately, the success and credibility of EPA decision depends 
upon the quality and integrity of the science behind them. The 
core mission of EPA is to protect public health. IRIS has a 
unique and essential role in supporting that mission.
    I'd like to close on a personal note. I'd like to 
acknowledge the great people of IRIS and EPA Office of Research 
and Development. They're dedicated public servants and world-
class scientists. They take on the toughest environmental 
challenges we face from the dust of the World Trade Center and 
faucets of Flint to the toxic waters of Katrina and Harvey. 
They have worked selflessly to protect our Nation's environment 
and public health. Our health depends on them; our health 
depends on the IRIS program.
    Thank you for the opportunity to speak with you today.
    [The prepared statement of Dr. Burke follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Chairman Biggs. Thank you, Dr. Burke, appreciate that. I 
appreciate the testimony of all of you, and I now recognize 
myself for five minutes to ask questions, and I'll start with 
Dr. Mundt.
    Dr. Mundt, in your testimony, you talked about the National 
Air Toxic Assessment and the findings and impacts that those 
findings had, and I'm wondering, you mentioned specifically 
precipitated--the NATA findings precipitated adverse public 
opinion, enforcement actions and a class-action lawsuit, all of 
which potentially have serious economic implications for DPE 
and the community. Can you tell us what impact that had with--
and how it relates to IRIS?
    Dr. Mundt. Certainly. The NATA enforcement action requires 
an exposure standard which is unattainable, largely because it 
used in its calculations the inhalation unit risk that we 
believe is at least 100-fold inflated from what the best 
scientific methods and processes would suggest. So I think the 
root of that particular problem arises with the erroneous 
derivation or the poor derivation of the IUR and then using it 
in a calculation to determine at what levels humans can safely 
be exposed.
    Chairman Biggs. And I'll continue with Dr. Mundt. The 
Science Committee has been committed to ensuring that the 
science of EPA is open and available to the American people, 
and that's why we passed the HONEST Act, which would require 
science that EPA uses to make decisions to be publicly 
available. In your experience, does the IRIS program live up to 
that transparency in science?
    Dr. Mundt. My experience with IRIS has been primarily with 
the chemicals chloroprene and formaldehyde. The reviews of both 
of those, at least the draft review for formaldehyde, were from 
2010. And of course, the NAS reacted also to the formaldehyde 
IRIS draft report identifying many of its problems. So I would 
say that yes, at least in 2010, there were significant problems 
that have led to more serious misinterpretations of the science 
and probably hardships for those who are impacted by those 
regulatory decisions.
    I hear a lot about progress being made and good intentions, 
and I look forward to seeing new IRIS assessments that have 
embraced all of those recommendations and quality improvements, 
but to date, I'm really focusing on what I have seen and what 
has been relied upon from some of the earlier IRIS assessments.
    Chairman Biggs. And Dr. Bus, in your testimony, you 
indicated that IRIS frequently does not effectively 
differentiate between highest quality science and that a 
substantially lower quality in its evaluations. Can you tell us 
how that might impact the regulatory environment of EPA and how 
we distinguish between the highest quality science and the 
lowest quality?
    Dr. Bus. Certainly, and thank you for the question. With 
respect to quality assessments, there are a number of 
mechanisms and tools that have been used across the agency, not 
necessarily specific to IRIS but to other programs of the 
agency, that are available for rating the quality of the 
science. Also, the EPA has made extensive investment in terms 
of development of what they call good laboratory practices and 
setting up of guidelines for how chemicals should be tested. 
Those studies are generally regarded as having the highest 
quality.
    But yet often when those studies are considered in the 
overall context of IRIS evaluation, you find as in the case of 
trichloroethylene, the default was to a study conducted by a 
single laboratory that turned out not to be reproduced under 
two conditions of studies conducted by good laboratory 
practices and using EPA guidelines for conduct of those 
studies. The implications of that obviously is incredibly 
important because depending on what science you use will make a 
big difference in terms of the outcome of the ultimate risk 
values that will be derived by the IRIS program, and that of 
course then ultimately drive the final risk assessment, which I 
mentioned in the case of trichloroethylene can translate to a 
very large economic impact. So in the case of 
trichloroethylene, there are many Superfund sites that had been 
remediated under the previous trichloroethylene remediation 
programs that had been regarded as now an acceptable point of 
remediation, with this new assessment conducted by 
trichloroethylene by the IRIS program, many of those sites now 
are facing reopening, each one of them costing in the range of 
several hundred thousand dollars to remediate to the new level 
identified by IRIS, and you spread that over the range of about 
a thousand additional sites that have been to have 
trichloroethylene associated with them, you can see the dollars 
add up very rapidly.
    But most importantly, that really brings home the message 
of why it's important that the agency has the proper expertise 
and means and review to use the highest quality science because 
the implications are important. Thank you.
    Chairman Biggs. Thank you.
    And now my time is expired and so I'll recognize the 
gentlewoman from Oregon, Ms. Bonamici.
    Ms. Bonamici. Thank you, Mr. Chairman, and thank you to the 
witnesses.
    Dr. Burke, I'm concerned about this Committee's lack of 
diligent oversight of the agencies in its jurisdiction since 
President Trump took office in January. In your opinion, how 
could this Committee best provide constructive oversight of the 
IRIS program with the goal of protecting public health of the 
American people? For example, are there informative witnesses 
we would benefit from hearing from as we try to learn more 
about the IRIS program?
    Dr. Burke. Thank you very much for the question, and yes, 
there are. IRIS has a daunting task, as I mentioned, and there 
are many members of the scientific community including the 
National Academy of Sciences, the Board on Environmental 
Studies, as I mentioned, that have been key to making sure IRIS 
documents may be the most scrutinized and peer-reviewed 
scientific documents the agency has ever produced. There is a 
tremendous review process, and there is a tremendous commitment 
to progress. We've seen a lot of change, as has been mentioned 
here, and I think you need to get the right kind of folks who 
have been involved in that change before you to really 
understand not just how important IRIS is but all the changes 
that have been made to solidify it, to listen to the comments 
of people like my colleagues here and to make sure the science 
is improved in a constant way.
    Ms. Bonamici. Thank you, Dr. Burke. And continuing, the 
mission of the EPA is to protect human health and the 
environment, and we know that, and you've served as a Science 
Advisor for EPA, and you've been an environmental public health 
professional your entire career, so I'd like to hear your 
opinion about the general direction now in this Administration 
with EPA Administrator Pruitt. Recently we've heard actions--
we've heard about actions at the EPA that are raising serious 
concerns including barring EPA scientists from attending 
scientific conferences, censoring use of the word ``climate 
change,'' politicizing the allocation of scientific grants, 
rejecting the conclusion of EPA scientists in banning some 
harmful chemicals. So Dr. Burke, many anti-science actions seem 
to be driving decisions at the EPA, so will you please discuss 
the public health implications of that for individuals across 
the country in light of these actions.
    Dr. Burke. Thank you for that question. It was a really 
comprehensive one. But I can address the public health issues 
and a concern of the public health community. Obviously there's 
many great debates about the application of science. We hear 
this today in IRIS, but across the board, and I think it's 
important that we follow the evidence. But what I'm concerned 
about in this quest for regulatory relief is that public health 
has been the collateral damage here, that we really have taken 
our eye off the ball and the primary mission of EPA. It's a 
public health agency, and the science is there to provide the 
foundations of that public health agency.
    Ms. Bonamici. Thank you very much, and I appreciate that. 
I've been on this Committee my entire time in Congress, and 
we've had many conversations about public health, and I share 
your concerns about losing focus on that important part of the 
EPA's mission. And I wonder if you--since the time you started 
at the EPA in 2015 and left earlier this year, how did the IRIS 
program change during your time with the agency during that 
period of time?
    Dr. Burke. Thank you for that question too. As my 
colleagues know, I've been involved in the National Academy 
overview of--and oversight of the IRIS process, and I am aware 
that there have been historical problems in the presentation of 
evidence and the management, and I worked like crazy to make 
sure we have the best people, that we listen to the Academy, 
that we begin to address the issue of problem formulation, 
which actually was part of a report that I chaired at the 
Academy to improve the IRIS process, and so I worked to get the 
best people there, to make sure we have the best scientific 
applications of systematic review, to address many of the 
concerns that you heard today, and the program is on a 
wonderful, positive trajectory.
    Ms. Bonamici. Thank you. I appreciate your work.
    Mr. Chairman, this hearing really seems incomplete without 
the participation of the EPA to answer questions about the IRIS 
program and how the Administration will prioritize the 
protection of health of the American people. There are many 
important environmental policies and public health issues that 
the Committee should be addressing: the effects of sea-level 
rise, ocean acidification, air quality--we're experiencing that 
in my home State of Oregon right now with terrible wildfires--
coastal resiliency efforts, the broad public health impacts of 
climate change, but this year the Committee has not hosted a 
single EPA official to testify about these important matters. 
It's unacceptable for this Committee to cede its jurisdiction 
and responsibilities to provide oversight of the federal 
agencies that are funded by our constituents. We should not go 
through an entire year without having an EPA official testify 
before this Committee, so I look forward to working with the 
Chairman and Chairman Smith. I hope we can get an 
Administration official to appear before this Committee as soon 
as possible.
    Thank you, Mr. Chairman. I yield back.
    Chairman Biggs. The gentlewoman's time is expired.
    The Chair recognizes Mr. LaHood.
    Mr. LaHood. Thank you, Mr. Chairman, and I want to thank 
the witnesses for your valuable testimony here today.
    Dr. Mundt, one of the intended steps in the IRIS process is 
independent expert peer review. I wanted to ask you, do you 
find that this peer review process adequately facilitates 
discussion from all relevant stakeholders, and particularly as 
you look at how IRIS utilizes or does not utilize independent 
third party?
    Dr. Mundt. Thank you. I think peer review in general is 
subject to the quality of the individuals selected and the 
amount of energy and efforts that they put into that peer 
review. This is true for published literature as well. Journal 
articles are subject to peer review but the quality of that 
varies from individual to individual.
    I assume that the same is true with the IRIS program, that 
peer review panels have varied in terms of their quality, and 
maybe more specifically in terms of their expertise. I've found 
with formaldehyde and with chloroprene there to be inadequate 
peer review support on the epidemiological literature and its 
interpretation. So I think that can be remedied. I think, 
though, that it will require more systematic assignment of peer 
reviewers and perhaps even provide some standard expectations 
or guidance that those peer reviewers deliver upon so that 
obvious errors or bigger problems or questions of greater 
concern that deserve scientific debate can be identified 
earlier in the process and not only after the final drafts have 
been made public.
    Mr. LaHood. Thank you. And Dr. Bus, do you want to comment 
on that also?
    Dr. Bus. Thank you, and I would agree certainly that peer 
review is a very important aspect of the overall program, and 
one of the real challenges because peer review is often 
conducted by individuals from the scientific community who are 
essentially serving as a labor of love in terms of it's not 
their full-time job requires that they have adequate time by 
way of example to prepare for these types of reviews. So I can 
describe a review if you want an illustration of has the agency 
and the IRIS program really learned its lessons in terms of 
valuing that input. Two reviews, which were just conducted 3 
weeks ago, the actual materials of the entire two reports for 
them to review were presented to them just 4 weeks before they 
were scheduled to deliver their final opinion. In my mind, 
that's woefully inadequately.
    Secondly, another example in terms of does the IRIS 
program, have they really understood that it's important to 
value the input of outside comment to their overall assessment. 
The year before those same reviews were conducted, they 
actually correctly held a public session to solicit public 
input. At that time, their own invited experts from the 
National Academy of Sciences indicated that the key endpoint 
that they were going to use for those evaluations definitely 
needed the consultation of an expert pathologist. One year 
later, this program was reviewed just 3 weeks ago by the EPA 
Science Advisory Board and it received severe criticism--this 
is a matter of public record--because the agency, the IRIS 
program had failed to follow up on that advice from their own 
National Academy consultant expert invited a year before. So 
that's an example of where although the IRIS may be talking 
going down the correct road, they still have a lot of need to 
actually put that into action, and it's not evident at least to 
date. Even as of events occurring just in the last several 
weeks that the IRIS program truly has reflected the advances 
that they are promoting and as claimed as successes, for 
instance, by way of to their presentation to the EPA Science 
Advisory Board.
    Mr. LaHood. Thank you, Dr. Bus.
    Dr. Mundt, I mentioned in my opening statement that IRIS is 
currently operating without specific statutory authority that 
would hold the program accountable. Do you believe IRIS would 
benefit from statutory guidance from Congress? And as a follow-
up on that, what else can Congress do to help ensure toxicology 
risk assessment is reliable and transparent, particularly with 
the backdrop of the National Academy of Science's study and 
also the GAO study?
    Dr. Mundt. Thank you. I think it's a challenging question, 
and the solution is not immediately apparent. However, 
scientists in general are striving for more or less one thing, 
that is, understanding the science and incorporating the best 
science, and so I think if statutory support for deriving the 
best science could work, then yes, of course, it would. But 
what this usually means is adequate time, as Dr. Bus mentioned, 
for proper review, the right scientists who are knowledgeable 
about the key topics, and also support for engagement, that is, 
all of the scientific interests and communities. I'm frequently 
referred to as an industry scientist but I'm really not. I'm an 
independent scientist looking at the science and often my 
understanding of the science is as great as anyone's having 
looked deeply into it yet that is often not welcomed in the 
circles where these issues have been debated at EPA and 
specifically at IRIS.
    Mr. LaHood. Thank you.
    Thank you, Mr. Chairman.
    Chairman Biggs. Thank you.
    The Chair recognizes the gentleman from Virginia, Mr. 
Beyer.
    Mr. Beyer. Mr. Chairman, thank you very much, and thank you 
all for the testimonies. It's very interesting.
    Dr. Burke, Dr. Bus identified three problems with IRIS, and 
the first was that they don't use--they're not good with 
problem formulation, and perfect sense. Do real-world exposures 
indicate reasonable need for a detailed risk assessment 
evaluation. Do you agree with his assessment? Is there some 
reason why IRIS isn't or shouldn't be using that?
    Dr. Burke. Well, first of all, IRIS has moved in the 
direction of starting with the right questions, and I think Dr. 
Bus rightly points out that there's a need to ask the right 
questions, and now that is built into the process. We don't 
want to have a number pulled out of the air of some bright line 
of what an acceptable risk is without providing a context, but 
let's go back to that example of TCE. TCE is probably one of 
the most pervasive environmental contaminants this world has 
ever seen from the drinking waters of Camp Lejeune to the 
Superfund sites all around the country. I personally have 
closed water supplies in New Jersey because TCE is such a 
pervasive environmental contaminant exposing millions of 
people. These are exactly the kinds of things that should drive 
our priority-setting process, drive our science, and drive our 
problem formulation.
    Mr. Beyer. It sounds like TCE would meet Dr. Bus's test of 
real-world exposure demonstrating reasonable need.
    Dr. Burke. Absolutely.
    Mr. Beyer. His second concern was that the IRIS program has 
yet to embrace the practice of mode of action information. Why 
have they been reluctant to do that? Do you agree that mode of 
action information is important?
    Dr. Burke. Mode of action information is important, and 
understanding those mechanisms is part of a major investment 
the agency has made in our computational toxicology and 
advancing the science but it's also important that we move 
ahead when we have evidence of a relationship to a health 
impact even though the mysteries of mode of action may not be 
there, and this is not just specific chemicals where we lack 
this information but we know in the complexities of multiple 
exposures in the environment and the way that the biology of 
the human works that this is a very challenging undertaking, 
and the challenge is, when you're charged with protecting 
public health, when do you have enough information to move 
ahead to reduce exposure and to support the regulatory 
decisions of the agency? So he raises some very important 
points that have been raised by the National Academy of 
Sciences, but therein lies the inherent uncertainty of the 
science base for decision making, and we have to constantly try 
to improve that, and I think with mode of action, we are doing 
that.
    Mr. Beyer. Great. Thank you.
    Dr. Mundt, it's nice to see a Dartmouth English major turns 
out okay. You had mentioned that there are large 
pharmacokinetic differences between mice and human beings. Is 
this an argument that we shouldn't be doing mice experiments, 
animal experiments? It seems to me that most of my adult life, 
we've been measuring cancer stuff with smaller animals.
    Dr. Mundt. Thank you. The answer is no, not at all. We 
should continue to use these very good experiments 
appropriately, but we have to--and as the previous two speakers 
have noted, there's been great advances in understanding the 
way that chemicals cause disease. It turns out the way that 
chloroprene, for example, causes tumors in mice is very 
different from rats and hamsters and humans, and that can be 
taken into the computational toxicological developments now in 
hand. In fact, in 2010, EPA had access to those methods and 
chose not to use them, and that was one of the basic points of 
my written testimony.
    So yes, I think there's full agreement here, and none of it 
suggests that we discontinue animal testing. We should probably 
reduce animal testing to that which is most necessary but it 
does inform human health risks and can be used if properly 
extrapolated to humans for risk control and exposure control.
    Mr. Beyer. Thank you.
    Dr. Burke, a very quick political question. Who was 
President in 1985 when IRIS was started? I'll go on. That's 
obvious.
    Dr. Bus, your third point was that who--that you need to 
use the highest quality science, and Dr. Mundt had the Bukowski 
chart. Who determines the highest quality science?
    Dr. Bus. Well, ultimately, obviously the IRIS program pulls 
together the science story as they believe it reflects the 
assessment for that compound being evaluated, but then it 
obviously is subjected to additional reviews by external 
parties including the science advisory panels as well as the 
external public such as members of the chemistry industry or 
other individuals interested or parties interested in that 
science. And then in the end, it is--it does come down to an 
issue of judgment although that judgment can be guided by, as I 
mentioned. There's been extensive investment by the federal 
government to define what constitutes a high-quality study, so 
we have a whole set of testing guidelines so that when we do 
toxicity tests in animals that they're done according to an 
accepted protocol that the scientific community universally 
agrees is sensitive and adequate to evaluate that particular 
endpoint of concern.
    And then likewise, we have an additional wide set of 
guidelines called Good Laboratory Practices to make sure that 
as those studies are conducted, we're keeping accurate records, 
and that if the additional other people interested in that 
science want to actually see the science record of that study, 
it will be available for them to scrutinize. That is one of the 
major problems that I certainly highlighted with the example of 
TCE where we have an example of the study that was driving the 
overall risk assessment for TCE was based on a study where the 
scientific records, the raw data, was not even available. The 
author admitted it was fundamentally lost so it couldn't be--it 
could not be reobtained for re-analysis. But yet the other two 
studies conducted of much higher quality studies, there was a 
full study report conducted according to Good Laboratory 
Practice according to EPA guidelines that was available for 
complete detailed review by the scientific community. It's 
those kinds of judgments that are really used to help 
differentiate what constitutes a high-quality study versus one 
of lesser quality studies, and in the end, it is a balancing 
act for sure, and it also has to deal with, well, how do the 
higher quality studies perform relative to the lower quality 
studies. So if you have a consistent pattern of high-quality 
study performance indicating one type of response but you have 
an outlier study where you're--of uncertain quality that gives 
you a totally different response, that certainly weighs in 
terms of your ultimate decision as to how you would look at 
that science, so thank you for the question.
    Mr. Beyer. Thank you, Mr. Chairman.
    Chairman Biggs. Thank you. The gentleman's time is expired.
    Without objection, a letter from Denka Performance 
Elastomer to Administrator Pruitt requesting that EPA withdraw 
and correct its IRIS review for chloroprene is entered into the 
record.
    [The information appears in Appendix II]
    Chairman Biggs. I now recognize the gentleman from Kansas, 
Mr. Marshall
    Mr. Marshall. Yeah, good morning. I'm a physician and a 
biochemist, so this is actually a pretty exciting topic to me. 
It feels like I'm back in college again.
    I think my first question is for Dr. Mundt. Chloroprene is 
neoprene, and that's one of your expertises. I think that 
you've been researching--I mean, obviously bathing your hands 
in these hydrocarbons is a little bit different than the 
different phases so I'm just very curious from a scientific 
standpoint how does IRIS or EPA deal with just whether the 
chloroprene is liquid, solid, vapor, and do they extrapolate 
the carcinogenic based upon perhaps the liquid phase compared 
to the synthetic--like our life jackets, I assume, are made out 
of neoprene, it looks like.
    Dr. Mundt. Thank you. I'm not an expert on the chemistry 
here but I understand that chloroprene is the monomer or the 
building block of neoprene like vinyl chloride monomer makes 
polyvinyl chloride. The end product is stable, a very different 
product.
    The only epidemiological studies that looked at--reliably 
looked at worker exposure were those done or overseen by Gary 
Marsh, Dr. Marsh from the University of Pittsburgh. Most of 
those studies were in the United States. One was in Ireland. 
And they had quantitative exposure estimates of workers to 
chloroprene from the largest plant in Louisville. There's the 
basis for what kinds of exposures humans can be exposed to. 
These are significantly higher than what might be anywhere 
outside of a plant. These are workers and probably the only 
people exposed to levels----
    Mr. Marshall. But they're not extrapolating the liquid 
product carcinogenic potential as opposed to the way the 
consumers are using it?
    Dr. Mundt. Well, consumers are typically not exposed to 
this material. In the workplace, though, the workers were 
exposed to the vapor, so it's in the air, and the risks are 
evaluated based on inhalation exposure.
    Mr. Marshall. The next question for Dr. Bus, if the EPA--if 
the EPA wants to revise or correct an IRIS assessment, does 
that ever happen, or how does the process work?
    Dr. Bus. Once an IRIS decision is closed, it can be 
reevaluated obviously because science changes with time. So the 
presumption would be that if a new piece of science came into 
the record that significantly impacted an existing IRIS review, 
that there should be a process available for reopening that 
IRIS record so that it could be revaluated in the context of 
that new science. One thing we certainly do know is the IRIS 
program reviews are not subject--although they're subject to 
reviews by science advisory panels, they're to subject to any 
legal review in the courtroom, at least as I understand it.
    Mr. Marshall. But practically speaking, does that happen? 
Does the EPA ever go back and look at them and make 
modifications to IRIS findings?
    Dr. Mundt. With some of its older compounds, yes, they do 
come back as new science comes onto the table. My understanding 
is, they have revisited some of their evaluations. But it is a 
very challenging process in terms of getting it to be reopened 
to be reevaluated.
    Mr. Marshall. Last question is about formaldehyde. I guess 
I'll go back to Dr. Mundt. There were some concerns about 
transparency in years past when the IRIS reviewed formaldehyde. 
Has the EPA improved in your estimation of that transparency 
process, or what steps else need to be taken to help it be more 
transparent?
    Dr. Mundt. I would say my interactions with EPA in the last 
couple of years regarding formaldehyde have been very 
professional, very cordial. There has been--we made a great 
effort to point out to IRIS all of the new science in the last 
six or seven years that has been published and is relevant to 
their evaluation.
    We have asked, however, for IRIS to identify what body of 
scientific papers are they relying on for the revised 
formaldehyde assessment, and that information has not been 
shared with us.
    Mr. Marshall. So they're not being transparent at this 
point?
    Dr. Mundt. I would say I can't say that there is any source 
that I can go to say what is EPA considering today including 
some of the most recent science that contradicts some of the 
older science.
    Mr. Marshall. Did they give you any explanation why they 
won't be more transparent or what's going on?
    Dr. Mundt. Not specifically. I'm assured that there are 
many changes underway but I was also told by Dr. Bahadori, now 
heading the NCEA program, that many of these changes will not 
have been implemented in time for the formaldehyde reissue or 
the finalization of formaldehyde.
    Mr. Marshall. I yield back. Thank you.
    Chairman Biggs. Thank you. The Chair recognizes the 
gentleman from Florida, Mr. Crist.
    Mr. Crist. Thank you very much, Mr. Chairman, and thank you 
to our panelists for being here today.
    I'm from Florida, as the Chairman noted, which means that 
obviously with the hurricanes that we've experienced in Texas 
and one that appears to be bearing down on my home state, these 
issues are in the forefront of my mind, so Dr. Burke, it leads 
me to a question for you. Can you explain to me and the 
Committee how IRIS risk assessments assist in disaster recovery 
and response, particularly related to hurricanes and flooding?
    Dr. Burke. Sure, and I've been there as a state official on 
the front lines. I've worked as a federal official with the 
environmental leadership of all of the 50 states, and the IRIS 
program is there. We're talking about the documents that those 
folks prepare today but I think what we're not talking about is 
the scientific expertise at the IRIS program, the folks that 
are there when Corpus Christi, Texas, has a question about an 
inadvertent chemical contamination of their water supply and 
has to understand what the exposures might be and what the 
risks might be. They're there when there's a complicated 
mixture from a release. They're there to provide in the case of 
Harvey, Region 6, our Dallas--or EPA's Dallas office--excuse 
me, I don't speak for EPA--but Region 6 with the expertise to 
understand how to take the samples, to understand the 
vulnerable populations, and to use the expertise of the IRIS 
program to really have a strong public health response to 
environmental disasters that are related to things like extreme 
weather.
    Mr. Crist. Would emergency responders be able to quickly 
and safely address the types of chemical spills that we're 
seeing in the wake of Hurricane Harvey without these risk 
assessments?
    Dr. Burke. Well, there are many ways that emergency 
responders need to get information, the first of which is 
understanding what's on site and whether that's reported and 
shared with the local communities, and that is not part of the 
IRIS program, but once things are known, IRIS is a reliable and 
important database that doesn't just look at cancer in rats and 
things like that but also looks at the acute exposure risks, 
the lethal dose, the short-term doses, the neurological 
effects, the respiratory effects, the irritant effects that 
we've heard about recently in Texas, and so yes, IRIS is there. 
It's a backstop for the states. It's an important tool.
    Mr. Crist. So it's safe to say that timely chemical 
assessments are pretty important in helping communities and 
families recover from the unthinkable?
    Dr. Burke. They're essential. They're absolutely essential.
    Mr. Crist. Thank you, Dr. Burke. As you know, the Trump 
Administration has proposed to eliminate the IRIS program among 
other important science programs as well as significantly cut 
staff at the EPA. Will the EPA be able to handle the recovery 
and response efforts after Hurricane Harvey and now after 
Hurricane Irma with a reduced staff, and how would the 
elimination or downsizing of the IRIS program affect the long-
term recovery of communities affected by storms and flooding?
    Dr. Burke. Well, it will have a profound effect on our 
national capacity to respond to chemical exposures and 
understanding those risks, and the unique combinations. For 
instance, I worked on the toxic combinations of water and what 
was called the toxic gumbo of Katrina. These are challenging 
risk assessments that need to be supported by data and good 
exposure science, and this is the kind of expertise that you 
have uniquely in IRIS that goes well beyond just the toxic 
substances program or looking at industrial chemicals. It 
really supports every aspect of our public health efforts, and 
it's really important to the state and local officials to have 
this resource, to have that number to call, to have those 
programs or the Office of Research and Development and IRIS 
there to support them.
    Mr. Crist. Thank you very much.
    Thank you, Mr. Chairman. I yield.
    Chairman Biggs. Thank you.
    The Chair recognizes the gentleman from California, Mr. 
Rohrabacher.
    Mr. Rohrabacher. Well, thank you very much, and let me just 
note that we hear charges all the time from people who claim 
that we are politicizing science by basically supporting 
positions that are not acceptable to other people who believe 
that their positions are sacrosanct, I guess, and should not be 
questioned.
    As a young man, I remember very well the whole issue of 
cyclamates. Do you fellows remember cyclamates? That was the 
industry--the soda pop industry put enormous amounts of money 
into developing a new sweetener, and it was cyclamates, and 
they were--and they got into the drinks and then all of a 
sudden it was said that cyclamates caused cancer, and they had 
to pull this out. It cost the equivalent of billions of dollars 
today when this whole thing--by the time it was finished, and 
then of course cyclamates were pulled out and then ten years 
later after a study, it was found that the cyclamates did not 
cause the cancer, and the Canadians had never abandoned 
cyclamates during that whole time. So we have to be very 
careful because those billions of dollars that were wasted in 
that particular instance could have been used for something 
else that was beneficial to us. For example, when the 
cyclamates were pulled out, I know that what came in was high-
fructose corn syrup instead, which may not cause cancer but my 
wife will not let me have anything that has high-fructose corn 
syrup in it. Now, whether or not that means because she's 
afraid of getting fat or whatever it is, the bottom line is, 
the cyclamates would have been more healthy for me than the 
high-fructose corn syrup.
    So there is harm done by chemicals and there's no doubt 
about that, and we should--and I'm very proud that Ronald 
Reagan signed this bill. I was working for Ronald Reagan at the 
time. I may have had something to do with the statement made on 
this issue years ago.
    But the harm done by cyclamates, or by chemicals and drugs, 
we also have to recognize there is a danger to be done by not 
permitting people to use beneficial chemicals and drugs that 
have had positive impacts on our lives, so we have to really be 
serious about it, and I would hope that the IRIS program is 
being serious about it and is not--does not succumb to what we 
have seen here over and over again as a politicalization of 
science, and it's not a politicalization that comes from oh, we 
have to represent some major financial interest but instead 
it's a politicalization where once an academe that something--
and Ph.D.'s, I don't know why they have this inclination but 
they've spent their life promoting a particular theory or 
they've come out and gotten grants on a particular theory and 
they will fight to the death to defend that theory even as more 
people come up and say well, that actually doesn't fit with 
what we've newly discovered, and I believe that manmade global 
warming, the fight in that, people have been denied--over and 
over again we have seen this over the years--denied research 
grants but those who claim to be so open-minded and liberal 
about this, and they've been denied people if they have any 
question as to whether or not mankind is causing global 
warming.
    So one question. I know we're running out of time here for 
my question. But the--we need to make sure that people are 
looking not just at the specific reaction to chemicals but also 
what is the threshold that someone--because we all ingest 
chemicals even natural chemicals all the time. The threshold is 
very important as well as the frequently of exposure, and are 
we being cautious enough to making sure that we do not take 
away the beneficial chemical results and chemical--things that 
chemicals can do for us? Are we--is that issue now being 
handled correctly by this program, or is this still a problem? 
And I just--for the whole panel.
    Dr. Bus. Thank you for that excellent question, and in 
fact, it really touches on the issue that Dr. Burke just 
touched on. The agency is called on on many occasions to deal 
with some very challenging issues such as events associated 
with hurricanes. That means that the staff that they have needs 
to be put in the right place at the right time, and they 
certainly cannot be diverted to efforts that ultimately are 
really not proving, as you say, necessary to improving public 
health.
    Let me give you a practical example of that. There's a 
compound that's under review right now by the agency called 
ethyl benzene. This is an intermediate compound, 99 percent of 
which in terms of its total chemical production is used as a 
closed system intermediate for the production of styrene, so 
it's a closed process. You're not going to have much releases 
to the environment as the result of that use. The other 
process--the other exposures to ethyl benzene come from its 
natural component of gasoline, which of course is assessed by 
other means independent of the ethyl benzene that's contained 
within it. It's another very small component of mixed xylenes, 
which is a commonly used solvent, but again, mixed xylenes are 
assessed for their own toxic independently.
    So why is this important? Well, EPA has set off in terms of 
projecting, and this is as of just a couple of weeks ago, the 
IRIS program notified that they were going to continue forward 
with the evaluation of ethyl benzene in terms of developing an 
IRIS evaluation of it. That's an extensive effort on their part 
which will consume staff time but yet over a year ago in a 
public problem formulation session, which was appropriately 
held for this compound, they were advised that this compound is 
a chemical intermediate all used in closed system production, 
and that its exposures, which have been monitored in the air 
across North America for many years, are less than one part per 
billion, which is the general air concentration associated with 
ethyl benzene, but here's the kicker. In the case of ethyl 
benzene in terms of the animal toxicity studies, the primary 
endpoint of concern is liver tumors in rats that are seen with 
ethyl benzene but they occur only at a concentration of 750,000 
parts per billion. Now, I would argue when you look at that 
data set alone, you would say that particular compound might 
not be worthy where significant resource investment by the 
agency justifies evaluation of a compound for that concern, and 
that frees the agency up to make the types of information flow 
that's necessary for the other critical elements that they're 
challenged with dealing with on an everyday basis, as Dr. Burke 
has already mentioned. So it's just one example that's actually 
currently in progress today so it's again another example of 
has the IRIS program truly learned and put into action what its 
words are versus where it's walking the talk. At least from my 
perspective I have some real concerns that that isn't the case. 
And the end result of it is, is just as you've just described. 
The necessary resources of the agency to truly protect public 
health, which I believe is exactly what they should be doing, 
are constrained when they're not making wise decisions as to 
where best to put their time in terms of evaluating the 
science.
    Chairman Biggs. Thank you, and the gentleman's time is 
expired.
    The Chair recognizes the gentleman from Texas, Mr. Weber.
    Mr. Weber. Thank you, Mr. Chairman.
    Dr. Burke, you said you spent some time in Houston. What 
part?
    Dr. Burke. Actually I was part of the downtown--I lived at 
the Texas Medical Center in student housing while I was 
pursuing my degree there, and part of the flood of 1976.
    Mr. Weber. Oh, I got you. Well, don't tell us how old you 
are now.
    Dr. Burke. I'm pretty old.
    Mr. Weber. You said in your written remarks ``the capacity 
to evaluate chemicals is essential to public health.''
    Dr. Mundt, you wouldn't disagree with that, would you?
    Dr. Mundt. No, sir.
    Mr. Weber. Dr. Bus, you wouldn't disagree with that, would 
you?
    Dr. Bus. Absolutely--have to do that.
    Mr. Weber. So I'm going to start back at the other end of 
the table.
    Dr. Mundt, have you ever known scientists to be wrong?
    Dr. Mundt. Quite frequently.
    Mr. Weber. Quite frequently?
    Dr. Bus, how about you?
    Dr. Bus. I would agree, but there are certainly processes 
now available to help resolve those disagreements among 
scientists. So for instance, I mentioned mode of action 
frameworks. They're an excellent way to resolve those types 
of----
    Mr. Weber. I just want to make the point that scientists--
well, let me get Dr. Burke in here first. Have you ever known 
scientists to be wrong?
    Dr. Burke. I sure have.
    Mr. Weber. Okay. So they're not infallible.
    One of the problems that I see with the way the program is 
that the IRIS assessment is not reviewable by courts. Are you 
aware of that, Dr. Mundt?
    Dr. Mundt. No, I'm not aware of that.
    Mr. Weber. Dr. Bus?
    Dr. Bus. Yes.
    Mr. Weber. Dr. Burke?
    Dr. Burke. I'll pass.
    Mr. Weber. Let's----
    Dr. Burke. I think that the regulatory application of IRIS 
is certainly consistently reviewed by the courts.
    Mr. Weber. Let me say it this way then. If that were in 
fact the case, the process is not reviewable by courts, would 
that be problematic, Dr. Mundt?
    Dr. Mundt. I have----
    Mr. Weber. I mean, if it's not reviewable by courts, do you 
see that as a problem?
    Dr. Mundt. I was going to say only if it's wrong. If it's 
right, then of course----
    Mr. Weber. That'd be great, but the courts----
    Dr. Mundt. --if we're wrong, where can you then turn.
    Mr. Weber. I got you.
    Dr. Bus, if it's not reviewable by courts, is that 
problematic?
    Dr. Bus. It can be in certain circumstances, yes.
    Mr. Weber. Dr. Burke?
    Dr. Burke. Again, I think the regulatory application is 
what the focus should be on, and my understanding is that is 
reviewable by courts, and very often are reviewed by courts.
    Mr. Weber. Let me read something that I have here. A March 
2008 GAO report noted that EPA has not been able to ``routinely 
complete critical IRIS assessments.'' More recently, a 2011 NAS 
report found that EPA's IRIS claims were not supported by its 
assessments, they were subjective, and that no clear scientific 
framework had been used by EPA to reach its conclusions. The 
NAS also stated that the IRIS program was deficient in meeting 
the benchmarks of objectivity, scientific accuracy, and 
transparency necessary to ensure high-quality and reliable 
assessments. Any of you all familiar with that report? Just a 
simple question. Dr. Mundt?
    Dr. Mundt. Yes.
    Mr. Weber. Dr. Bus?
    Dr. Bus. Yes.
    Mr. Weber. Dr. Burke?
    Dr. Burke. I assume that's from the 2011----
    Mr. Weber. Okay. So does that sound problematic to you, Dr. 
Mundt?
    Dr. Mundt. I've spent the last five, six years working on 
that issue with regard to formaldehyde.
    Mr. Weber. To you, Dr. Bus, is that problematic?
    Dr. Bus. Very much so.
    Mr. Weber. Dr. Burke?
    Dr. Burke. Yes, and----
    Mr. Weber. Okay. Thank you for that.
    Let me go to my fifth question. Dr. Burke, you said that 
you had personally, I think, closed down some water plants in 
New Jersey?
    Dr. Burke. Yes, sir.
    Mr. Weber. Is that right? You need to come back to Texas.
    You also said that you felt like that the IRIS was critical 
in emergencies like hurricanes where they can be out there on 
the ground taking samples. Is that a fair recounting of what 
you said?
    Dr. Burke. I think it's--yes.
    Mr. Weber. Are you familiar with the TCEQ in Texas, Texas 
Commission on Environmental Quality?
    Dr. Burke. Yes, I am.
    Mr. Weber. Are you aware that it is the second largest 
regulatory agency in the world second only to the federal EPA?
    Dr. Burke. I wasn't aware of that but I am familiar with 
it.
    Mr. Weber. Right. Well, I can tell you, having served in 
the Texas legislature for two terms, four years--I was on the 
environment reg committee--I can tell you that's a fact.
    Do you think the TCEQ would have a vested interest in 
having boots on the ground immediately in those areas and 
assessing those same kinds of situations?
    Dr. Burke. Yeah, I think the state responsibilities are 
essential, and they have that role.
    Mr. Weber. Okay. Well, I appreciate you all being here 
today. I think the statements, the evidence and the hearing 
kind of speaks for itself. Thank you, gentlemen.
    I yield back.
    Chairman Biggs. Thank you.
    The Chair recognizes the gentleman from Georgia, Mr. 
Loudermilk.
    Mr. Loudermilk. Thank you, Mr. Chairman, and thank all the 
members of the panel for being here.
    Dr. Burke, you mentioned that a member of the National 
Academy of Sciences, you've made recommendations for IRIS for 
certain reforms. Did I get that right?
    Dr. Burke. Yes, a 2009 report.
    Mr. Loudermilk. Have they followed through with those 
reforms that you've recommended?
    Dr. Burke. They are moving forward, yes, in a very 
responsive way but the reforms are challenging. There're 
inherent uncertainties in the science, and very often a lack of 
scientific information that make it challenging, but I'm very 
satisfied and have been part of pushing them to do just that.
    Mr. Loudermilk. So those recommendations are 2009, 2017, 
they still haven't implemented how much--are you projecting how 
long it's going to take?
    Dr. Burke. I can't speak for how the program is going now 
but I know that it was a focus of my efforts to improve that 
program, and they have implemented tremendous improvement.
    Mr. Loudermilk. Okay. Thank you.
    Dr. Mundt, 2017, the GAO in their High Risk Report set out 
numerous recommendations for IRIS. Others have as well. To your 
knowledge, has EPA established timelines for the different 
stages of the assessment process since the GAO report?
    Dr. Mundt. I've not seen any.
    Mr. Loudermilk. Okay. Dr. Bus, do you know?
    Dr. Bus. No.
    Mr. Loudermilk. Okay. I wouldn't expect if in 2009 they 
haven't made significant progress in the other recommendations.
    Dr. Bus, the 2017 GAO report also indicates that other EPA 
offices do not exclusively use IRIS assessments for information 
on toxicity. The use of alternative sources for toxicity 
information begs the question, are there in fact other sources 
better equipped to provide information IRIS assessments do not, 
and are these sources able to make up for IRIS shortfalls? So 
it appears that EPA doesn't even use its own data. Are you 
aware of that?
    Dr. Bus. Most of the science that the EPA considers in 
terms of its chemical evaluations is science coming from other 
sources. They do have their own Office of Research and 
Development but the vast majority of the science that the 
ultimately end up incorporating into their assessment comes 
from either industry sources or from primarily the academic 
environment. So those are the primary sources of the science 
that they use.
    Mr. Loudermilk. I guess what is IRIS used for if EPA 
typically doesn't use it?
    Dr. Bus. The primary purpose of IRIS is to pull together 
their IRIS evaluations, the objective of which is to develop 
what they call reference concentrations. So these are 
concentrations which they believe the public can be--the 
science says the public can be exposed to without reasonable 
concern for harm, and likewise, they also do cancer evaluations 
to say at what level of exposure is it acceptable where you 
might not be vulnerable to having cancer as a consequence of 
exposure to this agent, and that's where the debate often comes 
in with respect to IRIS evaluation because there the studies 
that you use as the basis for making those determinations for 
those key values, the reference concentrations and the 
reference doses and the cancer values are really what drive the 
regulatory action.
    So by way of example, Dr. Burke mentioned one of the things 
an emergency provider immediately would ask in the case of a 
chemical release associated with a hurricane by way of example, 
is there a reference--an acute reference concentration 
associated with this material. So if people happen to be 
exposed to the vapors or a first responder is exposed to the 
vapors, what do we know about the potential for that to cause 
that harm. So having that value is useful if you can measure it 
at the same time.
    Now, it's also fair to say that the agency is not the only 
agency--and here's another issue regarding redundancy. The 
National Academy of Sciences has an extensive battery of what 
they call acute emergency guidelines. That's--they have an 
entire committee devoted to saying in these acute circumstances 
like chemical releases associate with these natural disasters, 
the first responders can consult the EGL values and to say what 
can we expect, you know, as a consequence of exposure to the 
first responders and then ultimately to the surrounding 
population as well.
    So not having the IRIS there for those acute responses is 
certainly covered by other areas in the risk assessment 
community, so for instance, the National Academy and their EGL 
values.
    Mr. Loudermilk. Dr. Mundt, is IRIS in need of major reforms 
or is it duplicative now that we have other resources like Dr. 
Bus just brought up?
    Dr. Mundt. Well, the range of products IRIS produces is 
broad. It not only includes the reference concentrations but 
it's one of the main organizations, the other being the 
National Institute for Environmental Health Sciences and the 
National Toxicology Program for classifying substances as 
carcinogenic. So there's another area where there's some 
redundancy. I think one of the other could do this but in every 
case it ought to be done well with high-quality science. So I 
don't think that all of the functions of IRIS currently could 
be absorbed by other organizations.
    Mr. Loudermilk. But we do----
    Chairman Biggs. The gentleman's time is expired.
    Mr. Loudermilk. --need major reform.
    Dr. Mundt. It's clear that there are major reforms underway 
because the problems have been recognized. Whether and at what 
rate they'll be implemented is yet to be seen.
    Mr. Loudermilk. Thank you, Mr. Chairman.
    Chairman Biggs. Thank you.
    The Chair recognizes the gentleman from California, Mr. 
Takano.
    Mr. Takano. Thank you, Mr. Chairman.
    Dr. Burke, good morning.
    Dr. Burke. Good morning.
    Mr. Takano. Despite the vital function IRIS provides in 
assessing the public health dangers of chemicals and recent 
findings by both GAO and the Academies that EPA has made 
progress in improving the IRIS process, this Administration 
proposed to eliminate the program altogether. My first question 
is, why would that matter? As a former state environmental 
official and former EPA Science Advisor, you bring a unique 
perspective to the table regarding the usefulness of IRIS. How 
does the program help state and local officials, public health 
professionals and the public? But first answer the question of 
why would it matter?
    Dr. Burke. Well, it matters tremendously to the frontline 
people in public health and environmental protection that we 
have a consistent source of information. I remember the chaos 
before 1983 when the risk assessment process got started in 
1985 when IRIS was established, and we risk returning to 50 
different solutions. As strong as some states may be, I think 
the business community does not want 50 different solutions, 50 
different numbers, and certainly the health effects aren't 
different in the states. And so it would be a chaotic situation 
if that program were no longer there to respond to the Nation's 
environmental chemical priorities.
    Mr. Takano. Well, what impact would eliminating IRIS have 
on EPA's statutory obligations?
    Dr. Burke. Well, the National Center for Environmental 
Assessment and the IRIS program really are the starting point 
for the science. EPA is only as strong as the science that 
supports its decisions, and EPA has very clear statutory 
authorities for clean air and clean water and the cleanup of 
hazardous waste. Each one of these is guided by science whether 
it's for a cleanup value or a contaminant level for drinking 
water or an air quality standard. Without IRIS, without the 
scientific engines that support that mandate, I feel that EPA 
would fail to meet its public health responsibilities
    Mr. Takano. Well, based on these impacts, does it make it--
does it make sense to reduce overall staff or monetary 
resources for the IRIS program?
    Dr. Burke. Again, I think it's an essential capacity for 
not just EPA but the Nation. Reducing that staff is very 
shortsighted, and I think would have profound effects not just 
on public health but on our business community as well.
    Mr. Takano. So it doesn't make sense at all to reduce the 
staff.
    Dr. Burke, as you state in your testimony, the scientific 
peer review process is essential to producing credible results, 
addressing uncertainties, and explaining the scientific basis 
for conclusions. And contrary to what some of my Republican 
colleagues believe, the peer review process is a critical part 
of how we conduct science in this country and around the world. 
Could you expand on your testimony and describe for us exactly 
why peer review--why the peer review process is built into IRIS 
and why is it so essential?
    Dr. Burke. Sure. Independent peer review is essential. All 
of the data, as was said by my colleagues here, that EPA uses 
is from the academic community, the scientific community, the 
industry community, and is peer reviewed prior to being part of 
this synthesis of information, but IRIS documents are subject 
to the highest levels of peer review, first through committees 
of the EPA's Science Advisory Board, and very often for the 
high-profile, high-impact compounds or substances, the National 
Academy of Sciences, our highest level of scientific expertise 
in this country, and so it is essential to be independent and 
it is essential that it be reviewed with the kind of scrutiny 
and the kind of updating that was suggested here today.
    But I have to mention one very important distinction 
between stakeholder input and scientific--independent 
scientific peer review. These are very different things, and 
sometimes we get confused about having stakeholders express 
their opinions on things, on the cost of regulations and things 
like that that is important but very different than the 
independence of the scientific review, and I fear that we may 
have gotten these things kind of crossed and what you see is a 
frustration on the part of stakeholders because they don't like 
the answer. Because in my experience in 40 years, I have never 
seen a stakeholder industry come forward with their risk 
assessment and say EPA, you got it wrong, your number is way 
too high, this is bad stuff. It's always recommending a more 
lenient approach with the public's health.
    Mr. Takano. Thank you, Dr. Burke.
    Chairman Biggs. Thank you.
    The Chair recognizes the gentleman from Texas, Mr. Babin.
    Mr. Babin. Thank you, Mr. Chairman. I thank the witnesses 
as well.
    Dr. Bus, do IRIS assessments properly consider real-world 
regulatory and risk management implications of its hazard 
assessments?
    Dr. Bus. The risk management applications, if I understand 
it, is actually outside the domain of the IRIS program. Their 
intention is just--and their objective and their responsibility 
is to assess the science that ultimately then is translated for 
use by the risk managers. However, if that science is not 
pulled together in a way that represents the best reflection of 
the practice of that science, it will result in poor risk 
management decisions. So by way of example, I mentioned the 
trichloroethylene example. I'll come back to that. The risk 
managers now are faced with the potential option of saying do 
we need to revisit all of the Superfund sites that had been 
resolved for trichloroethylene, do they need to be reopened now 
as a result of this reassessment conducted by the IRIS program. 
That's how it flows into a risk management decision.
    Mr. Babin. Okay. Thank you. Thank you very much.
    And then Dr. Mundt, does IRIS use a weight-of-evidence 
framework that incorporates all relevant and reliable data?
    Dr. Mundt. This is one of the key criticisms that the 
earlier NAS committees identified, and I understand there's 
efforts in place to move toward this. But in the two 
chemistries that I've been involved with for the last few 
years, it's clear that that was not the case. The--especially 
epidemiological human health studies were all considered as 
equals where there were some that were considerably stronger 
and others that were considerably weaker. Preferentially, we 
tend to favor the results from studies that are well conducted, 
well documented, large numbers, strong exposure assessments and 
whatever they say, which should drive the assessment.
    Mr. Babin. Okay. Thank you very much.
    One more question, and Dr. Bus, if you don't mind, what 
steps in the current IRIS process are most troublesome to you? 
You've mentioned some already, but with chemical toxicity, does 
one process fit all or should it be tailored based on the type 
of chemical and the need for speedy assessment?
    Dr. Bus. You've put your finger on certainly several of the 
key issues. The ability to identify which compounds really need 
the attention of the agency to the degree of investment that 
they engage in with an IRIS evaluation certainly is important. 
The other area in which the IRIS program has struggled with 
mightily without coming to any effective resolution even as of 
the last several reviews that have just been released over the 
last--this summer, and that is, how to use mode of action 
science, and why is that important? The vast majority of the 
decisions that are made with respect to evaluating the health 
effects of chemicals arises from data flowing from animal 
toxicology studies because we simply don't have often--I'm sure 
my colleague, Dr. Mundt, would agree--the horsepower in 
epidemiology necessarily to tease out those health effects so 
we rely on animal studies. But we also know animals are not 
little people, and that in some cases they don't behave the 
same way biologically as do adults, and we can also--because we 
can put these animals in cages and give them any amount of 
chemical that we choose, we often use doses that are far 
disparate from real-world exposures, and now we recognize that 
doing that kind of science often can generate results that are 
fundamentally not quantitatively relevant to human risk. So the 
risk program has, I'll have to admit, over its entire existence 
struggled mightily with the use of mode of action data, and I 
don't believe you can hardly point to a single example where 
mode of action science despite the extensive investment in the 
scientific community paid for and generate that science where 
it's ever been effectively used.
    Mr. Babin. I understand. Thank you very much.
    I yield back the balance of my time, Mr. Chairman.
    Chairman Biggs. Thank you. The gentleman yields.
    And now I thank the witnesses for your testimony. It's very 
valuable, very insightful, very interesting today, and the 
members for their questions. The record will remain open for 
two weeks for additional comments and written questions from 
members.
    This hearing is adjourned.
    [Whereupon, at 11:45 a.m., the Subcommittees were 
adjourned.]

                               Appendix I

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                              Appendix II

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                   Additional Material for the Record

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