[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
[GRAPHIC NOT AVAILABLE IN TIFF FORMAT]
Available via the World Wide Web: http://science.house.gov
__________
U.S. GOVERNMENT PUBLISHING OFFICE
27-173PDF WASHINGTON : 2017
----------------------------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Publishing Office,
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center,
U.S. Government Publishing Office. Phone 202-512-1800, or 866-512-1800 (toll-free).
E-mail, [email protected].
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.
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
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
----------
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Appendix II
----------
Additional Material for the Record
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
[all]