[House Hearing, 116 Congress]
[From the U.S. Government Publishing Office]


                   EPA'S IRIS PROGRAM: REVIEWING ITS
                     PROGRESS AND ROADBLOCKS AHEAD

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

                             JOINT HEARING

                               BEFORE THE

              SUBCOMMITTEE ON INVESTIGATIONS AND OVERSIGHT
                      SUBCOMMITTEE ON ENVIRONMENT

              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             MARCH 27, 2019

                               __________

                            Serial No. 116-9

                               __________

 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                    
37-709PDF                  WASHINGTON : 2019                     
          
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              COMMITTEE ON SCIENCE, SPACE, AND TECHNOLOGY

             HON. EDDIE BERNICE JOHNSON, Texas, Chairwoman
ZOE LOFGREN, California              FRANK D. LUCAS, Oklahoma, 
DANIEL LIPINSKI, Illinois                Ranking Member
SUZANNE BONAMICI, Oregon             MO BROOKS, Alabama
AMI BERA, California,                BILL POSEY, Florida
    Vice Chair                       RANDY WEBER, Texas
CONOR LAMB, Pennsylvania             BRIAN BABIN, Texas
LIZZIE FLETCHER, Texas               ANDY BIGGS, Arizona
HALEY STEVENS, Michigan              ROGER MARSHALL, Kansas
KENDRA HORN, Oklahoma                NEAL DUNN, Florida
MIKIE SHERRILL, New Jersey           RALPH NORMAN, South Carolina
BRAD SHERMAN, California             MICHAEL CLOUD, Texas
STEVE COHEN, Tennessee               TROY BALDERSON, Ohio
JERRY McNERNEY, California           PETE OLSON, Texas
ED PERLMUTTER, Colorado              ANTHONY GONZALEZ, Ohio
PAUL TONKO, New York                 MICHAEL WALTZ, Florida
BILL FOSTER, Illinois                JIM BAIRD, Indiana
DON BEYER, Virginia                  VACANCY
CHARLIE CRIST, Florida               VACANCY
SEAN CASTEN, Illinois
KATIE HILL, California
BEN McADAMS, Utah
JENNIFER WEXTON, Virginia
                                 ------                                

              Subcommittee on Investigations and Oversight

              HON. MIKIE SHERRILL, New Jersey, Chairwoman
SUZANNE BONAMICI, Oregon             RALPH NORMAN, South Carolina, 
STEVE COHEN, Tennessee                   Ranking Member
DON BEYER, Virginia                  ANDY BIGGS, Arizona
JENNIFER WEXTON, Virginia            MICHAEL WALTZ, Florida
                                 ------                                

                      Subcommittee on Environment

                HON. LIZZIE FLETCHER, Texas, Chairwoman
SUZANNE BONAMICI, Oregon             ROGER MARSHALL, Kansas, Ranking 
CONOR LAMB, Pennsylvania                 Member
PAUL TONKO, New York                 BRIAN BABIN, Texas
CHARLIE CRIST, Florida               ANTHONY GONZALEZ, Ohio
SEAN CASTEN, Illinois                JIM BAIRD, Indiana
BEN McADAMS, Utah                    VACANCY
DON BEYER, Virginia
                         
                         C  O  N  T  E  N  T  S

                             March 27, 2019

                                                                   Page
Hearing Charter..................................................     2

                           Opening Statements

Statement by Representative Mikie Sherrill, Chairwoman, 
  Subcommittee on Investigations and Oversight, Committee on 
  Science, Space, and Technology, U.S. House of Representatives..     9
    Written Statement............................................    11

Statement by Representative Ralph Norman, Ranking Member, 
  Subcommittee on Investigations and Oversight, Committee on 
  Science, Space, and Technology, U.S. House of Representatives..    13
    Written Statement............................................    15

Statement by Representative Lizzie Fletcher, Chairwoman, 
  Subcommittee on Environment, Committee on Science, Space, and 
  Technology, U.S. House of Representatives......................    17
    Written Statement............................................    19

Statement by Representative Roger Marshall, Ranking Member, 
  Subcommittee on Environment, Committee on Science, Space, and 
  Technology, U.S. House of Representatives......................    21
    Written Statement............................................    23

Statement by Representative Frank D. Lucas, Ranking Member, 
  Committee on Science, Space, and Technology, U.S. House of 
  Representatives................................................    25
    Written Statement............................................    26

Written statement by Representative Eddie Bernice Johnson, 
  Chairwoman, Committee on Science, Space, and Technology, U.S. 
  House of Representatives.......................................    29

                               Witnesses:

Panel 1:

Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant 
  Administrator for Science and Senior Advisor, Office of 
  Research and Development, Environmental Protection Agency
    Oral Statement...............................................    31
    Written Statement............................................    33

Mr. Alfredo Gomez, Director, Natural Resources and Environment, 
  Government Accountability Office
    Oral Statement...............................................    41
    Written Statement............................................    43

Discussion.......................................................    58


Panel 2:

Dr. Bernard D. Goldstein, Professor Emeritus and Dean Emeritus at 
  University of Pittsburgh Graduate School of Public Health
    Oral Statement...............................................    75
    Written Statement............................................    77
Dr. Ivan Rusyn, Professor, Department of Veterinary Integrative 
  Biosciences; Chair, Interdisciplinary Faculty of Toxicology; 
  and Director, Superfund Research Center, Texas A&M University
    Oral Statement...............................................    84
    Written Statement............................................    86

Dr. Julie E. Goodman, Principal, Gradient
    Oral Statement...............................................    97
    Written Statement............................................    99

Ms. Wilma Subra, President, Subra Company; and Technical Advisor, 
  Louisiana Environmental Action Network
    Oral Statement...............................................   103
    Written Statement............................................   105

Discussion.......................................................   123

             Appendix I: Answers to Post-Hearing Questions

Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant 
  Administrator for Science and Senior Advisor, Office of 
  Research and Development, Environmental Protection Agency......   140

Mr. Alfredo Gomez, Director, Natural Resources and Environment, 
  Government Accountability Office...............................   147

            Appendix II: Additional Material for the Record

Letter from the American Chemistry Council submitted by 
  Representative Ralph Norman, Ranking Member, Subcommittee on 
  Investigations and Oversight, Committee on Science, Space, and 
  Technology, U.S. House of Representatives......................   150

Letter from the Colorado Department of Public Health & 
  Environment submitted by Representative Lizzie Fletcher, 
  Chairwoman, Subcommittee on Environment, Committee on Science, 
  Space, and Technology, U.S. House of Representatives...........   155

EPA Executive Summary submitted by Representative Bill Foster, 
  Committee on Science, Space, and Technology, U.S. House of 
  Representatives................................................   157

 
                   EPA'S IRIS PROGRAM: REVIEWING ITS
                     PROGRESS AND ROADBLOCKS AHEAD

                              ----------                              


                       WEDNESDAY, MARCH 27, 2019

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

    The Subcommittees met, pursuant to notice, at 10:01 a.m., 
in room 2318 of the Rayburn House Office Building, Hon. Mikie 
Sherrill [Chairwoman of the Subcommittee on Investigations and 
Oversight] presiding.
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    Chairwoman Sherrill. This hearing will come to order.
    Without objection, the Chair is authorized to declare 
recess at any time.
    Good morning, and welcome to the Investigations and 
Oversight Subcommittee's first hearing of the 116th Congress. 
I'm pleased to work alongside Ranking Member Norman of South 
Carolina and look forward to a productive and collaborative 
relationship.
    This is also a joint Subcommittee hearing with the 
Environment Subcommittee, and I'm very pleased to welcome my 
fellow Chair Mrs. Fletcher, who's on her way, and her 
counterpart in the minority, Representative Marshall of Kansas. 
I expect this is just the beginning of the cooperative 
partnership that our Subcommittees will enjoy during this 
Congress, and I look forward to continuing to work closely with 
you in the weeks and months ahead.
    In this first hearing, we are focusing on a subject that 
directly impacts the state of public health in this country. 
The EPA's (Environmental Protection Agency's) Integrated Risk 
Information System, or IRIS, is tasked with developing 
impartial, science-based assessments on toxicity of chemicals. 
It is considered the gold standard for chemical toxicity 
assessments in the United States, and note that IRIS is not 
itself a risk management program or a regulator. Instead, its 
findings are used by other branches of the EPA and State and 
local governments to inform guidelines and regulations about 
what levels of human exposure to a given chemical are 
acceptable.
    IRIS has produced toxicity assessments for a multitude of 
dangerous chemicals, including asbestos, mercury and ethylene 
oxide, to name a few. Unfortunately, we have learned in recent 
weeks that IRIS is being undercut by political leadership at 
the EPA. America needs a strong, empowered IRIS to provide EPA, 
States, tribes, municipalities, and communities everywhere with 
the best-available science regarding chemical toxicity.
    When IRIS is prevented from doing its work, the public is 
less informed, and therefore less safe. The public needs IRIS 
to be independent of outside influence, but the GAO report we 
will discuss today outlines troubling facts about political 
interference with IRIS. Political appointees at EPA have 
blocked the release of IRIS assessments, imposed new 
bureaucratic hurdles, and reduced the number of priority 
chemicals for IRIS to evaluate with no explanation.
    The formaldehyde assessment in particular has been ready to 
be released for over a year. Then-EPA Administrator Scott 
Pruitt said so himself in a January 2018 hearing before the 
Senate. Press reports indicate that IRIS has determined a 
connection exists between formaldehyde and leukemia. It is 
unacceptable for political considerations to suppress IRIS' 
findings. I fail to see any credible reason why findings of 
fact on chemical risks should be withheld from the public. EPA 
must release the IRIS formaldehyde assessment as soon as 
possible.
    EPA's management of the IRIS Program has prompted concern 
as well. In October 2018, 28 out of roughly 30 IRIS employees 
spent 25 to 50 percent of their time working on risk 
evaluations for a different EPA office. This kind of staff 
reassignment distracts IRIS from its core mission and deprives 
IRIS of the resources it needs to address its own work in a 
timely fashion.
    I'm very pleased to welcome the distinguished witnesses 
appearing here today. And in our two panels, we have government 
officials, eminent scholars, and community advocates who see 
the real-world impact of IRIS assessments. We appreciate your 
willingness to appear before our Subcommittees today.
    Protecting the public from toxic chemicals is a core 
function of the EPA, and IRIS is vital to the EPA's ability to 
accomplish its mission. I'm pleased to have the opportunity to 
continue this Committee's work to ensure that IRIS is allowed 
to do its job for the sake of public health.
    [The prepared statement of Chairwoman Sherrill follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Chairwoman Sherrill. The Chair now recognizes Mr. Norman 
for an opening statement.
    Mr. Norman. Thank you so much, Chairwoman Fletcher and 
Chairwoman Sherrill. Thank you all for convening this meeting. 
I want to thank the witnesses for taking your time to come. 
It's very important what you're doing.
    We're here today to examine the EPA's Integrated Risk 
Information System program, which is also called IRIS. This 
hearing provides an opportunity to review the issues and 
challenges that burden the IRIS Program, steps that IRIS has 
taken toward addressing these issues, and challenges that 
remain today. I'm hopeful that our expert panel of witnesses 
will paint a detailed picture of how to improve the IRIS 
Program and remedy issues that have burdened us for years.
    As Ranking Member of the Investigations and Oversight 
Committee, I approach this issue from an oversight perspective, 
focused on how to improve IRIS. With a background in business 
and real estate, I've learned how burdensome and costly, 
onerous regulations have become.
    My experience in the real estate business has also taught 
me a thing or two about construction. For example, one of the 
primary tenets of construction is that your foundation is 
critical. If you build atop a faulty foundation, the entire 
structure is at risk and likely ruined where it stands.
    As I understand it, IRIS assessments are analogous to a 
structural foundation. In preparing chemical assessments, IRIS 
conducts the first two steps of the risk assessment process: 
First, a hazard identification; second, a dose-response 
assessment. EPA's program and regional offices then rely on 
IRIS assessments and the foundation for conducting the last two 
steps of the risk assessment process, including an exposure 
assessment and a risk characterization.
    As with a structural foundation, if an IRIS assessment is 
based on flawed information, or is itself faulty, then it 
jeopardizes all subsequent work that builds atop a faulty 
foundation. As a result, faulty assessments can lead to bad 
regulations and unnecessary public health scares. The IRIS 
Program must continue to address transparency issues that have 
plagued it over the past decade because Americans need 
assurance that sound science forms the foundation for 
government regulations.
    The U.S. Government Accountability Office (GAO) added IRIS 
to its list of government programs that are highly vulnerable 
to risk of waste, fraud, abuse, and mismanagement in 2009. IRIS 
was added to GAO's ``High-Risk List'' because actions were 
needed to streamline and increase the transparency and the 
dependency of IRIS assessments. Despite attempts at improvement 
and efforts to remedy its challenges over the past decade, IRIS 
remains on the High-Risk List today.
    In addition to its High-Risk List, GAO recently published a 
report that examined IRIS' efforts to improve its chemical 
assessment process and implement outstanding recommendations. 
While GAO commended IRIS for its efforts to address identified 
challenges, it also appropriately recognized that there 
remained much room for much improvement, especially with 
respect to issues of timeliness and transparency.
    I want to thank the GAO for its great work. However, I was 
puzzled by certain findings regarding EPA leadership. In both 
reports, GAO seemed to fault EPA's leadership for delaying 
IRIS' progress. It also appeared that EPA leadership was 
chastised for failing to publicly commit to making IRIS a top 
priority, as was done by a previous Administrator, under a 
prior Administration.
    I would suggest that a brief pause may have been necessary 
to adequately address the issues and challenges that IRIS faces 
and develop a plan of action for future progress. For example, 
think about repairing a rollercoaster. If you don't try to fix 
a malfunctioning rollercoaster while it's rolling around full 
of people. Instead, you suspend operations, you pull the cars 
off the track for evaluation, which makes for a better ride and 
safer in the end. Perhaps delays due to EPA leadership 
deliberation and assessment of IRIS should be handled in a 
similar fashion.
    Despite its issues and challenges, the IRIS Program must 
still serve a critical function. And everyone here today 
recognizes the importance of ensuring Americans are protected 
from the dangers and hazards that IRIS aims to combat. It is 
for this reason that we must ensure IRIS' work is transparent, 
scientifically sound, and carried out in a timely and an 
efficient manner.
    I look forward to a productive and insightful discussion 
with our distinguished witnesses about the issues and 
challenges that the IRIS Program faces and the efforts that 
IRIS has made in remedying them, and what remains to be done to 
ensure that IRIS lives up to its potential.
    Thank you, Madam Chairwoman. I yield back.
    [The prepared statement of Mr. Norman follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    Chairwoman Sherrill. Thank you, Mr. Norman.
    The Chair now recognizes the Chairwoman for the 
Subcommittee on the Environment, Mrs. Fletcher, for an opening 
statement.
    Mrs. Fletcher. Thank you, Madam Chairwoman. Good morning. I 
would like to join the Chairwoman and Ranking Member Norman in 
welcoming all of our witnesses on both panels here today.
    The EPA's IRIS Program conducts human health assessments 
that look at the health effects of chemical exposures in the 
environment. IRIS assessments are unique in providing 
information on chemical exposures and environmental hazards 
that may affect the general population, including children and 
the elderly, and that can occur over a lifetime. IRIS 
assessments follow a thorough process that includes internal 
and external peer review, as well as opportunity for public 
input.
    While the IRIS Program suffered from timeliness and 
transparency issues earlier this decade, the program has 
incorporated many recommendations from the GAO and the National 
Academies of Sciences that have improved its processes. The 
IRIS Program was intentionally placed in EPA's Office of 
Research and Development, a nonregulatory program office at the 
Agency, to ensure that only credible science guided the 
development of its impartial assessments, which are not 
regulatory in nature.
    There are many Federal, State, and local stakeholders, 
however, that rely on IRIS assessments to help make regulatory 
decisions that protect public health. Program and regional 
offices within the EPA routinely rely on IRIS assessments to 
guide their risk-management decisions. IRIS assessments are not 
only considered to be--are not considered to be duplicative of 
other Federal chemical assessments like those carried out under 
the EPA's Toxic Substances Control Act, or TSCA.
    This is why the recent series of announcements by the EPA 
removing the chemical formaldehyde from its IRIS workflow and 
adding it to its TSCA workflow is concerning. It appears to 
reset the clock on a late-stage IRIS assessment. Non-Federal 
stakeholders, including community groups and State, local, and 
tribal agencies, rely on IRIS assessments not only because of 
their rigor and thoroughness, but also because many of these 
entities do not have the capacity to conduct such thorough 
toxicity assessments on their own. The values derived in IRIS 
assessments are routinely the top choice of State regulatory 
bodies in their standard-setting work because they are the most 
thoroughly developed and vetted values available.
    Because of its rigorous process and the reliance of both 
Federal and non-Federal stakeholders of IRIS assessments to use 
them to direct risk-management decisions relating to public 
health, the program plays a unique role that is complementary 
to other review processes like TSCA.
    Given this background, the findings of the GAO's March 4 
report detailing political interference in the publication of 
IRIS assessments raise serious concerns. The EPA is responsible 
for protecting public health and the environment through the 
application of sound science and should not be creating 
internal roadblocks to performing this critical mission.
    That is why I am glad we will be hearing from witnesses on 
both of our distinguished panels today, hearing from the EPA 
and GAO on the findings of this recent the GAO report and 
gaining a better understanding of the need for and importance 
of IRIS assessments, the improvements the program has made over 
the years, and the critical role these assessments play in 
protecting public health.
    And with that I yield back.
    [The prepared statement of Chairwoman Fletcher follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]

    Chairwoman Sherrill. Thank you, Madam Chairwoman.
    And the Chair now recognizes Mr. Marshall for an opening 
statement.
    Mr. Marshall. Thank you, Chairwoman Fletcher and Chairwoman 
Sherrill, for holding this hearing, and thank you to the 
witnesses for being here today.
    The EPA's IRIS Program was established to identify and 
characterize the health hazards of chemicals found in the 
environment. The program conducts chemical hazard 
identification and dose response assessments, which serve as a 
source of toxicity information for EPA program and regional 
offices as well as State and local agencies.
    As a physician, I understand the importance of chemical 
toxicity assessments and their role in protecting the 
environment and advancing public health, particularly for 
sensitive populations such as children, pregnant women, and the 
elderly. Accordingly, it should be our top priority to ensure 
the underlying science that goes into these assessments is of 
the highest quality. Unfortunately, the IRIS Program has a poor 
track record in this department, and despite some recent 
progress by EPA leadership, many issues remain.
    Two of the most troublesome problems for the IRIS Program 
are its inability to produce final products in a timely manner 
and an unexplained lack of scientific transparency in the 
assessment process. Both the National Academy of Sciences (NAS) 
and the Government Accountability Office (GAO) have recently 
published reports that criticize the program and make 
recommendations for improvement.
    The National Academy of Sciences has published three 
reports detailing similar problems while making suggestions for 
reform and improvement of the program. The NAS reports in 2011 
and 2014 found serious problems with IRIS and proposed sweeping 
recommendations to overhaul the program. If those 
recommendations had been fully implemented within the last 8 
years, the program would be operating in a more functional 
manner and able to produce chemical assessments in a way that 
is timely, transparent to the public, and reflective of the 
best current scientific methodologies. Instead, we continue to 
live report to report, looking at incremental progress and an 
overall lack of tangible results.
    The 2018 NAS review commends IRIS for its progress to 
implement systematic review of chemical assessments. And while 
I agree that IRIS' progress is commendable, several other 
critical products and recommendations remain unaddressed and 
incomplete. Publication of a robust handbook that details 
internal process, incorporation of mode-of-action information, 
and utilization of a weight-of-evidence framework are a few 
examples of simple objectives that have not been accomplished 
despite recommendations to do that. I hardly find the 2018 NAS 
review consequential in its praise of the program. In fact, I 
think it is a clear indication that a lot of work remains.
    Likewise, the GAO has issued ongoing criticism of the 
program. In 2009, GAO added the IRIS Program to its High-Risk 
List, which identifies Federal programs with heightened 
vulnerabilities to fraud, waste, abuse, and mismanagement. Even 
with clear deficiencies pointed out and the EPA seemingly 
taking steps toward a few of the recommendations for 
improvement, the program continues to appear on the High-Risk 
List to this day.
    Separate of the High-Risk List, GAO recently issued a 
report that was largely critical of current EPA leadership and 
its efforts to manage and update the IRIS Program. Democrats 
and environmental groups continue to point to this report as 
evidence that the Trump Administration is trying to stifle 
science. On the contrary, I think these efforts are critical to 
overhauling a flawed program so it's responsive to program and 
regional office needs and best serve EPA's core mission. The 
program has many issues that need to be addressed, and EPA 
leadership is taking necessary steps to do just that.
    One of the most troubling issues with IRIS is the 
publication of misleading or questionable information that can 
create confusion for Americans regarding the health risks 
associated with a given chemical. The 2016 IRIS assessment for 
ethylene oxide is a prime example. Naturally produced by the 
human body and plants, ethylene oxide is produced commercially 
to sterilize medical equipment. OSHA (Occupational Safety and 
Health Administration) set a safety standard of 1 part per 
million for workers exposed 8 hours a day, 5 days a week. This 
seems to be a reasonable value given that high, long-term 
exposure may increase cancer risks.
    EPA's IRIS Program, however, set a lower risk value at 100 
parts per quadrillion. And I think that's about a difference of 
10 to the 9th. That value is 19,000 times lower than naturally 
occurring levels of ethylene oxide in the human body. 
Essentially, this assessment correlates to a normal human 
metabolism, and breathing ambient air is enough to cause 
cancer.
    It is clear that much work remains before IRIS assessments 
can be tabbed as the gold standard review that the program was 
established to be. Meeting objective and transparent standards 
for evaluating chemical risks will require substantial changes 
and improvements to the program. I'm hopeful that one day soon 
the IRIS Program will be able to produce high-quality, 
scientifically sound chemical assessments that are widely 
accepted by the scientific community, and I look forward to 
working with my colleagues to ensure this happens.
    Thank you, and I yield back.
    [The prepared statement of Mr. Marshall follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Chairwoman Sherrill. Thank you, Mr. Marshall.
    We are pleased to have the Full Committee Ranking Member, 
Mr. Lucas, with us today, so the Chair now recognizes the 
Ranking Member for an opening statement.
    Mr. Lucas. Thank you, Madam Chair, and thank you to all the 
witnesses for being here today to discuss EPA's IRIS Program.
    Over the last 10 years, numerous reports have been issued 
criticizing the IRIS Program for its lack of transparency, 
improper scientific processes, and ineffectiveness in 
addressing the needs of EPA regional and program offices. The 
flaws are well-documented. Current EPA leadership is taking 
positive steps to address these issues, and I laud their 
progress. However, we have yet to see a completed assessment of 
the IRIS Program that fully incorporates all of the 
recommendations made in the last decade.
    Unfortunately, that means there are numerous IRIS 
assessments in the database that are questionable, unreliable, 
and in some instances just plain incorrect. Take IRIS' 
assessment of ethylene oxide, which is used to sterilize 
medical equipment. In fact, some medical equipment can't be 
sterilized by any other chemical. In 2016, IRIS set an absurd 
risk value that is 19,000 times lower than the levels of this 
chemical that naturally occur in the human body. Assessments 
like this can have disastrous effects on the economy and human 
health if relied upon by government agencies in crafting 
regulation.
    Accordingly, today's hearing raises an important theme: How 
we characterize the chemicals in the environment. 
Unfortunately, there are too many government agencies, both 
national and international, that mischaracterize risk 
associated with chemicals. These agencies, just like the IRIS 
Program, have a history of identifying extremely conservative, 
even paranoid levels of exposure that can be classified as 
carcinogenic.
    Another program with a poor track record of assessing risk 
is the International Agency for Research on Cancer, IARC. 
Unlike IRIS, IARC's problems go beyond bad science. IARC is 
plagued by a severe lack of transparency and accountability, as 
well as significant conflicts of interest. But other parallels 
with IRIS exist. IARC assessments have led to the 
classification of things like red meat and coffee as being 
carcinogenic. States like California adopt these assessments at 
face value and slap a warning on every product imaginable. The 
public promptly ignores these warnings because they know coffee 
will not give them cancer. In the end, we are left with useless 
and ineffective regulations that only serve to waste taxpayer 
money.
    Although the IRIS Program does not have regulatory 
authority, it is important to note the consequences of when 
government agencies miscategorize risk. As I said, I'm pleased 
the current Administration is taking a thoughtful and 
meaningful look at how we characterize I should say, chemical 
risk. I'm hopeful these efforts will bear fruit. In the 
meantime, we will remain vigilant in ensuring that programs 
like IRIS are useful, transparent, and effective in meeting 
EPA's core mission of protecting human health and the 
environment.
    I yield back, Madam Chairwoman. Thank you.
    [The prepared statement of Mr. Lucas follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Chairwoman Sherrill. Thank you, Mr. Ranking Member.
    If there are Members who wish to submit additional opening 
statements, your statements will be added to the record at this 
point.
    [The prepared statement of Chairwoman Johnson follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Chairwoman Sherrill. At this time I would like to introduce 
the witnesses for our first panel: Dr. Jennifer Orme-Zavaleta, 
the Principal Deputy Assistant Administrator for Science with 
the Office of Research and Development and the Science Advisor 
for the Environmental Protection Agency, the EPA; and Mr. 
Alfredo Gomez, Director of the Natural Resources and 
Environment team with the Government Accountability Office, the 
GAO. Mr. Gomez is also the principal author of the March 2019 
GAO report on the Integrated Risk Information System, IRIS, 
which is the basis of our hearing today.
    As our witnesses should know, you will each have 5 minutes 
for your spoken testimony. Your written testimony will be 
included in the record for the hearing. When you all have 
completed your spoken testimony, we will begin with the 
questions, and each Member will have 5 minutes to question the 
panel. We will start with Dr. Orme-Zavaleta.

            TESTIMONY OF DR. JENNIFER ORME-ZAVALETA,

          PRINCIPAL DEPUTY ASSISTANT ADMINISTRATOR FOR

             SCIENCE AND SCIENCE ADVISOR, OFFICE OF

                  RESEARCH AND DEVELOPMENT, EPA

    Dr. Orme-Zavaleta. Thank you, and good morning, Chairwomen 
Fletcher and Sherrill, Ranking Members Marshall and Norman, and 
other distinguished Members of the two Subcommittees. My name 
is Jennifer Orme-Zavaleta, and I'm the Principal Deputy 
Assistant Administrator for Science in EPA's Office of Research 
and Development (ORD). I also act as the Agency's Science 
Advisor. My responsibility as the career lead for ORD is to 
ensure that we provide solid and robust science to inform 
Agency decisions.
    I have worked for EPA since 1981 in the areas of human 
health and ecological risk, research, policy development, 
strategic planning, and program implementation. Of these nearly 
38 years, I've spent 26 in ORD, which is the parent office of 
the Integrated Risk Information System, commonly called IRIS. I 
appreciate the opportunity to talk with you today about IRIS. I 
was at EPA when IRIS was created, and I've seen it grow into 
the rigorous scientific program it is today.
    ORD's highly trained IRIS staff helped the program's 
regions, States, and others assess the risk of potential 
exposures to chemicals and nonchemical contaminants. IRIS 
assessments are a key part of this, providing the first two 
steps of the risk-assessment process: Hazard identification and 
dose-response assessment. This information informs risk 
assessments that are conducted by EPA programs, regions, 
States, and others, though some EPA programs conduct their own 
hazard and dose-response assessments.
    IRIS assessments provide a scientific foundation for 
decisionmaking under an array of environmental laws. The IRIS 
assessment process ensures transparency, scientific rigor, and 
provides opportunities for public, stakeholder intra- and 
interagency engagement. This process also includes robust 
independent scientific peer review.
    In 2011 and 2014, the National Academy of Sciences issued 
reports outlining recommendations to improve the IRIS Program 
by adopting systematic review, and this is known for 
transparency and scientific rigor. In 2017, IRIS began to 
implement systematic review across its assessments, and since 
then, IRIS has made assessment plans and protocols available to 
the public earlier in the assessment development process, 
providing more time to consider scientific complexities.
    In a report published in April 2018, the National Academies 
concluded that IRIS has made substantial progress. GAO has also 
provided input to improve the IRIS Program, which has included 
suggestions to increase timeliness, transparency, and process 
challenges. In a recent audit report, GAO found that IRIS has 
made improvements and has demonstrated the impacts of actions 
that we've taken. IRIS has made these improvements by 
incorporating project and program management by moving away 
from a one-size-fits-all assessment to a mixed portfolio of 
chemical evaluation products. In addition, IRIS has optimized 
systematic review software tools, which are increasing the 
efficiency and promoting greater transparency by making 
information more accessible to the public.
    With these changes, a large segment of the assessment 
portfolio can now be completed in 1 to 3 years instead of 3 to 
10. The GAO report noted this, indicating that the preparation 
of several recent draft assessments has taken months, not 
years. To ensure that these new and improved processes are 
successful, IRIS has extensively trained its staff and is 
extending this training across the Agency and to the 
stakeholder community as well.
    Another major challenge--change in how IRIS operates is in 
how EPA programs request and prioritize IRIS assessments. 
Because IRIS assessments play such a critical role, the EPA 
Administrator requested a formal process signed off at the 
Assistant Administrator level, through which programs identify 
what IRIS assessments are a priority, when they are needed, and 
why they are needed. This process was completed in December and 
identified 11 priority chemicals. This formal process is a 
great improvement, as it brings further stability and 
responsiveness to the IRIS Program while also reinforcing 
accountability between the requesting program office and the 
IRIS Program. We will continue to conduct this process 
annually, though programs may nominate a new assessment at any 
time.
    Now that the prioritization process is complete, the public 
and stakeholders can expect to see IRIS assessments move 
forward. Last week, IRIS released a systematic review protocol 
for hexavalent chromium, and we plan to release other 
assessment materials soon. The formal prioritization process, 
along with the improvements in IRIS, has made--has helped us to 
address the NAS and GAO recommendations, and this will continue 
to make IRIS more efficient and a more effective program.
    We recognize that we still have work to do, but I am 
confident that as we move forward and address these open--we 
will address these open recommendations and concerns identified 
by the GAO.
    So thank you for the opportunity to appear before you 
today, and I look forward to answering your questions.
    [The prepared statement of Dr. Orme-Zavaleta follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Chairwoman Sherrill. Thank you, Dr. Orme-Zavaleta.
    And now, I would like to recognize Mr. Gomez for his 
testimony.

                   TESTIMONY OF ALFREDO GOMEZ,

          DIRECTOR, NATURAL RESOURCES AND ENVIRONMENT,

                GOVERNMENT ACCOUNTABILITY OFFICE

    Mr. Gomez. Chairman--Chairwomen Sherrill and Fletcher, 
Ranking Members Norman and Marshall, and Members of the 
Subcommittees, good morning. I'm pleased to be here today to 
discuss our work on EPA's efforts to address toxic chemicals.
    As has been noted, EPA is responsible for reviewing 
chemicals in commerce and for those entering the marketplace. 
EPA's ability to effectively implement its mission of 
protecting public health and the environment depends on its 
credible and timely assessments of the risks posed by these 
chemicals. The Agency's Integrated Risk Information System 
program, which is under the Office of Research and Development, 
identifies and characterizes the health hazards of chemicals 
and produces human health toxicity assessments. EPA program and 
regional offices rely in part on these assessments to make risk 
management decisions.
    My statement today summarizes our March 2019 report on 
EPA's efforts to produce IRIS assessments. I will discuss the 
extent to which the IRIS Program has made progress in 
addressing identified challenges and in producing chemical 
assessments. And as has already been noted by the Committee, we 
also recently issued our High Risk update, which includes 
transforming EPA's process for assessing and controlling toxic 
chemicals.
    Just as a matter of background, I wanted to mention that 
the IRIS Program uses a seven-step process to produce 
assessments, so there's a lot of review that's built into the 
process. First, EPA has to determine the scope and the 
questions that the assessment will cover, and these are 
released for review and public comment. The draft assessment is 
then developed using systematic review. After the full draft is 
developed, it goes through agency review, interagency review, 
and external peer review and public comment. After staff make 
revisions to address the comments, the draft then goes through 
another round of internal and interagency review. Then the 
program finalizes and posts the assessments to the IRIS 
website.
    So historically, developing IRIS assessments has been a 
lengthy process and typically takes several years to complete. 
The IRIS Program has made progress addressing timeliness and 
transparency challenges in the assessment process. So, for 
example, the IRIS Program is now employing project management 
principles and specialized software to better plan assessments 
and utilize staff. In addition, the program has begun 
assessments that are more limited in scope and targeted to 
specific program and regional office needs.
    The IRIS Program has implemented systematic review, which 
provides a structured and transparent process for identifying 
relevant studies, reviewing their methodological strengths and 
weaknesses, and integrating these studies as part of weight-of-
evidence analysis.
    In early 2018, EPA made progress on assessments that were 
in development. However, EPA leadership deliberations delay the 
release of some assessments by 6 months. So in June 2018, the 
Administrator's office told IRIS officials that they could not 
release any IRIS documentation without a formal request from 
EPA program office leadership. In August 2018, the Office of 
Research and Development asked program offices through a survey 
to reconfirm which of the 20 ongoing chemical assessments they 
needed. Several program offices responded confirming their 
needs for these assessments.
    Then in late October 2018, prior to releasing the results 
of the initial survey, these offices were asked to limit their 
chemical requests further to the top three or four assessments. 
EPA leadership did not provide them a reason for the limit or 
guidance on prioritizing assessments.
    Then finally in December 2018, as has been noted, EPA 
publicly issued its IRIS Work Plan, which provided an updated 
list of 13 assessments. Eleven of the 13 chemicals on the IRIS 
Work Plan were requested by two EPA program offices. The two 
remaining assessments were already at external peer review. EPA 
gave no indication of when additional assessments could be 
requested or what the IRIS Program's workflow would be in the 
future.
    While the program's work was delayed, EPA directed 28 of 
approximately IRIS staff to support implementation of TSCA with 
25 to 50 percent of their time according to officials. It is 
unclear if this is a temporary workforce shift or if TSCA will 
require this level of support moving forward.
    So, Chairwomen Sherrill and Fletcher, Ranking Members 
Norman and Marshall, and Members of the Subcommittees, this 
concludes my statement. I'd be pleased to answer questions.
    [The prepared statement of Mr. Gomez follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Chairwoman Sherrill. Thank you, Mr. Gomez.
    At this point we will begin our first round of questions. 
The Chair recognizes herself for 5 minutes.
    First of all, Mr. Gomez, I want to commend you and your 
colleagues at the GAO on your thorough and meticulous work in 
the report that was published on March 4. The Subcommittee 
appreciates your efforts to help us better understand the 
status of the IRIS Program.
    Can you summarize the GAO's findings regarding the recent 
EPA's leadership decisions that hindered IRIS' ability to 
complete its toxicity assessments?
    Mr. Gomez. Maybe I can just provide another summary of 
the--as our audit documented, the steps. As I mentioned 
earlier, it started in August with ORD sending out a survey to 
all of the program offices to reconfirm whether the 20 ongoing 
assessments were still needed. And so offices then responded to 
that. In fact, there were three offices, program offices, that 
responded that they needed the majority of those assessments. 
In fact, it was the Office of Land and Emergency Management 
which requested that all 20 of those chemical assessments were 
needed. The Office of Water requested 15 of those, and the 
Office of Children's Health Protection requested 18. Also, the 
Office of Policy did confirm all of them.
    And as I also noted, then in October the--sorry, there was 
then--there was then a request in mid-October, a second time, 
for offices to reprioritize and to further reduce the number of 
assessments to three or four.
    Chairwoman Sherrill. And so you had mentioned also in 
releasing the reports that I believe it was August--it was in 
2018. A new policy came out that you had to ask leadership to 
release the reports or get authorization----
    Mr. Gomez. Yes, so essentially before an IRIS assessment 
could be issued, it had to be requested by an Assistant 
Administrator or even if you needed an assessment, that it 
needed to be at that level.
    Chairwoman Sherrill. OK. And before that, how did it work?
    Mr. Gomez. The IRIS officials, the offices would just work 
with the program offices at EPA and ask them what----
    Chairwoman Sherrill. Determine----
    Mr. Gomez [continuing]. They needed.
    Chairwoman Sherrill. And then we've been talking a bit 
about the 2011 National Academies' review of IRIS' draft 
formaldehyde assessment, and it identified areas for IRIS to 
improve. Much has changed since then, so can you also--and you 
spoke a little bit about timeliness and transparency, but can 
you also provide an overview of the progress that IRIS has made 
since 2011 in improving its assessment process?
    Mr. Gomez. Sure. So that's also something that we discussed 
in our High Risk update report where we lay out the areas in 
which--and I think it's been mentioned by a number of the 
Members of the Committee already that there are a number of 
areas in the IRIS Program where there have been improvements in 
terms of them using systematic review, in terms of them trying 
to improve the timeliness process, and so there have been a 
variety of areas that we covered in terms of building the 
capacity of the program, making sure that they have an action 
plan in place. And so those are the areas that we highlight, 
and we gave the program a rating of partially met in all of 
those areas because we do see a lot of progress. And, as has 
been noted, this is a program that historically has taken a 
long time to do chemical assessments, and so we see that 
there's a lot of improvement that's been taking place.
    Chairwoman Sherrill. And yet now some of the timeliness 
problems are because leadership is holding up the ability to 
release the assessments?
    Mr. Gomez. So, as we noted in our report, in that 6-month 
period, there was a delay while these deliberations were taking 
place, and so that's what we were calling attention to.
    Chairwoman Sherrill. And finally, can you detail the IRIS 
staff reassignments in support of the Toxic Substances Control 
Act that occurred in October 2018?
    Mr. Gomez. Sure. So as we noted in the report and as I 
noted in my statement, there--EPA directed 28 of their 30 IRIS 
staff to support implementation of TSCA, and they were 
providing anywhere from 25 to 50 percent of their time.
    Chairwoman Sherrill. Thank you very much.
    I will now recognize Mr. Norman for 5 minutes.
    Mr. Norman. Thank you, Chairwoman Sherrill.
    In the 2014 report, the National Academy of Sciences 
specifically recommended that EPA finalize and release a 
handbook that outlines the IRIS assessment evaluation process. 
This recommendation was reiterated in 2018. The NAS evaluation 
of IRIS which stated that the EPA would complete the handbook 
in 2018.
    Mr. Gomez, in preparing the recent reports, was the GAO 
provided a copy of the IRIS handbook?
    Mr. Gomez. Yes, we have it. It's a draft copy because it 
has not been finalized yet. And that is something that we are 
also tracking, and so we've been looking to see when EPA is 
going to release that.
    Mr. Norman. OK. Dr. Orme-Zavaleta, have you reviewed the 
IRIS handbook?
    Dr. Orme-Zavaleta. And please feel free to call me 
Jennifer.
    Mr. Norman. I'll call you doctor.
    Dr. Orme-Zavaleta. I know my name's a mouthful. So we have 
a draft IRIS handbook that has gone through Agency review; it 
was initiated last summer. We received comments all the way 
through to December. We had our 5-week hiatus with the 
shutdown. We are still in the process of addressing some of the 
comments that came in and will continue to work toward 
completing that document.
    Mr. Norman. When will it be ready for publication in your 
opinion?
    Dr. Orme-Zavaleta. So we're--conversations with some of the 
commenters are still ongoing. Some of the questions are not as 
easily identified, and in my opinion was going to extend into a 
broader conversation across the Agency, so we'll have to see 
how we can complete the document. And for those issues that 
need further work, what will be the process for addressing 
those.
    Mr. Norman. Can you identify this morning what the hold up 
is exactly, and I guess when it will be completed with where 
you are, where you see it?
    Dr. Orme-Zavaleta. So some of the conversation is around 
how we evaluate hazard and how we identify or categorize areas 
of hazard, and these are conversations that involve more than 
one office, and so this is something that I'm looking to engage 
other parts of the Agency through our risk assessment forum to 
address whether that holds up this document or not. I think 
that's something that we still have to determine. So my hope is 
that we complete this soon, but this is a process that we are 
continuing. I've raised with the Administrator, and hopefully, 
we'll have a path forward on how to address.
    Mr. Norman. Well, I mean, in my world--I mean, I'm a real 
estate developer. I look on a handbook as a blueprint to go by 
on projects. If you don't have a handbook, you really can't 
move forward. And the excuses I've heard--am I right? It hasn't 
been completed in 8 years?
    Dr. Orme-Zavaleta. What hasn't been completed in 8 years?
    Mr. Norman. The handbook.
    Dr. Orme-Zavaleta. So I don't know when the handbook was 
initiated. I came into this role over this past year. But 
elements of the handbook are being captured in some of our 
systematic review protocols, and those documents are moving 
forward. So the document we just released last week on 
hexavalent chromium incorporates elements of that handbook. So 
we are utilizing that blueprint, and we're able to move forward 
on our assessments. The particular handbook is an internal 
guide for us, and just completion of that is something that 
we're still working through comments.
    Mr. Norman. But it's very important to have the handbook--
--
    Dr. Orme-Zavaleta. Absolutely.
    Mr. Norman [continuing]. As a guide so you can adequately 
move forward.
    Dr. Orme-Zavaleta. And we are utilizing that internally and 
running it through our assessment so that we keep those 
assessments moving.
    Mr. Norman. Thank you. Mr. Gomez, the GAO has reviewed the 
IRIS Program over many years and multiple Administrations. In 
the GAO's review of the IRIS Program, has it found that the 
IRIS Program has regularly produced timely assessments for you 
all?
    Mr. Gomez. No, sir. One of the findings is that it takes a 
long time, many years, to produce assessments, and so, as has 
been noted and discussed, we and the National Academies have 
made recommendations to improve the timeliness of those 
assessments.
    Mr. Norman. Well, with that, then, do you think the IRIS 
Program should remain high on the GAO's High-Risk List?
    Mr. Gomez. So we--we have it on a High-Risk List because we 
do see that it needs improvement to produce those assessments 
that are needed by other EPA program offices and folks outside 
of EPA, so until we see demonstrated progress in the program, 
it's going to remain on the list, yes.
    Mr. Norman. Well, I would stress the importance of getting 
it in. In my world we're on penalties if we don't make 
something in a timely response. I can't just say to our 
tenants, you know, we're trying. It gives you an ending and a 
beginning date. Eight years to me is out of the question. Thank 
you all so much.
    Chairwoman Sherrill. Thank you. I now recognize Chairwoman 
Fletcher for 5 minutes.
    Mrs. Fletcher. Thank you, Madam Chairwoman. Thank you to 
the witnesses this morning. Your testimony has been helpful.
    My first question is directed at Dr. Orme-Zavaleta. 
According to the EPA, the role of the Office of Science 
Advisor, or OSA, is to provide leadership on science and 
technology issues and policy to facilitate the integration of 
the highest quality science into the Agency's policies and 
decisions. As the current acting EPA Science Advisor can you 
discuss the OSA's role in EPA's strengthening transparency in 
regulatory science proposed rule? Was the OSA consulted during 
the drafting of this proposed rule before it was submitted to 
the Federal Register?
    Dr. Orme-Zavaleta. So the answer to that is no. The 
science--the STPC (Science and Technology Policy Council) was 
given a briefing once the proposal was out and has been aware 
of the next steps. The Agency received a number of comments. 
We're still going through and synthesizing those comments, and 
then we'll determine our next steps forward.
    Mrs. Fletcher. OK. And on a related note, the EPA 
ostensibly bases its environmental and public health protection 
regulations on robust science. How often do you engage with 
regulatory program offices within the Agency and provide 
scientific input on new regulatory actions? For example, how 
often are you consulted on the Agency's deregulatory actions?
    Dr. Orme-Zavaleta. So the--in the regulatory process, the 
Agency establishes an ADP (Action Development Process) 
workgroup, which is a--I don't remember the specific acronym, 
but it engages representatives across the Agency and is 
overseen by the lead office with the particular regulatory 
action. So our office and our staff are engaged when they have 
these workgroups formed and working through the different 
regulatory efforts.
    Mrs. Fletcher. How often do you meet with Administrator 
Wheeler to provide scientific input into decisionmaking at the 
highest levels of the EPA?
    Dr. Orme-Zavaleta. So I have a regular monthly meeting with 
the Administrator. I also see him weekly for--he meets with 
our--the senior leadership across the Agency. And then if there 
are specific rulemaking activities or issues to be addressed 
and there will be a meeting convened for briefing and either I 
or my staff will be involved in those discussions.
    Mrs. Fletcher. And how often did you or your predecessor 
meet with Administrator Pruitt for the same purpose?
    Dr. Orme-Zavaleta. So less. Each Administrator has their 
own style and approach, and with Administrator Pruitt he 
participated in senior staff meetings periodically, but I did 
not have an opportunity to meet with him as a representative of 
ORD.
    Mrs. Fletcher. Thank you, Dr. Orme-Zavaleta.
    One other question relating to the GAO report is the GAO 
found that by October 2018 that more than 90 percent of IRIS 
staff were spending up to half their time supporting risk 
evaluation under TSCA, is that correct? And so----
    Mr. Gomez. That is correct, yes.
    Mrs. Fletcher. OK. So, Dr. Orme-Zavaleta, since Congress 
has clearly expressed its intent that the IRIS Program remain 
within ORD, how could EPA justify diverting staff hired for the 
sake of implementing IRIS to other program offices within the 
Agency?
    Dr. Orme-Zavaleta. So just to be clear, the staff remained 
in ORD, and within the Agency, ORD is a partner with a number 
of our program offices working through different scientific 
issues, whether it's helping with implementation of TSCA or 
working with the Office of Water on some of their science 
issues or OLEM (Office of Land and Emergency Management) or 
others. So we take a one-EPA approach in leveraging the 
expertise and experience across the Agency for the different 
types of scientific disciplines. Some offices may not have as 
many types of scientists that ORD has, and so we work with them 
collaboratively in trying to sort through these different 
issues.
    Mrs. Fletcher. OK. And I want to follow up on one other 
question that one of my colleagues asked about the publication 
of the IRIS handbook. I know that we've already discussed it a 
little bit, but can you give us any insight into what has 
caused the delays in its publication?
    Dr. Orme-Zavaleta. So, again, we submitted the handbook for 
Agency review toward the end of last summer. We had comments 
come in through the course of the fall, some as late as 
December, and then with the shutdown that set us behind, so we 
are doing catch up and we are working through some of the 
issues that have been raised.
    Mrs. Fletcher. OK. Thank you. I yield back the remainder of 
my time.
    Chairwoman Sherrill. Thank you. The Chair now recognizes 
Representative Biggs.
    Mr. Biggs. Thank you, Madam Chair, and thank you, 
panelists, for being here today.
    I think it's no secret to anybody who's watched my 
performance on this Committee that I've been a longtime critic 
of the IRIS Program. In the last Congress, while serving as the 
Chairman of the Environment Subcommittee, I sponsored 
legislation to effectively eliminate IRIS in its current form 
and return chemical assessments to the appropriate program 
offices of EPA. That bill, the Improving Science in Chemical 
Assessments Act, was voted out of the full SST Committee last 
July. I've reintroduced this bill the current Congress, but I 
doubt for some reason that it'll be reported out of this 
Committee again anytime soon. And I'm disappointed with that of 
course, that the chemical assessments process at EPA has not 
received a complete structural overhaul despite years' and 
years' worth of criticism and observations by the NAS and GAO.
    That said, apparently, there have been few glimmers of hope 
at EPA over the last couple of years, and I'm happy about that, 
but clearly, there are at least some high-level officials at 
the Agency who generally believe that: One, chemical 
assessments should rely on good, transparent, publicly 
available science, and that's true. And two, chemical 
assessments should be carefully tailored to serve program and 
regional office needs, and I'm happy about that.
    And I want to hear more from your perspective, Mr. Gomez. 
The most recent GAO report on the IRIS Program reiterates yet 
again that EPA should develop an action plan that, among other 
reforms, places primary responsibility for chemical assessments 
in the relevant program offices. Is that a fair 
characterization?
    Mr. Gomez. No, sir.
    Mr. Biggs. Please state how would you characterize it?
    Mr. Gomez. So, the way IRIS came about, it was because 
there were many different program offices doing their own 
chemical assessments, sometimes different values were 
generated, and so this was an effort to centralize and to come 
up with Agency consensus on these assessments. And I'm sure 
that Jennifer can also talk about that history and evolution of 
the IRIS Program. So that is our understanding of it.
    And our reports on the High-Risk List on IRIS are looking 
to improve the IRIS Program to make it more timely, to make it 
more transparent, as you said, so that it is using the best 
available studies that are out there, and it's going through 
the proper levels of review both internal and external peer 
review.
    Mr. Biggs. Well, can you explain why the EPA leadership has 
been criticized for beginning to do what GAO has been 
requesting?
    Mr. Gomez. So and--again, in our current report we focus 
on--we do talk about the progress that EPA is making, which 
we've been chatting about, but we also talk about other 
challenges that the program is facing. And so we were drawing 
attention to the delays in issuing the assessments. As we've 
said, these assessments take a long time, sometimes years to 
do, so that's what we've been focusing on. And there is a lot 
of progress, and we do note that in the ratings that we do for 
the IRIS Program, but yet there's still challenges ahead.
    Mr. Biggs. Well, one of the interesting pieces of testimony 
that I'm taking from this today, is this notion of the 
handbook, the handbook that may have been ordered 8 years ago, 
recommended 8 years ago, certainly recommended 4 years ago, and 
yet I think it just takes a lot of moxie to come in here today 
and say, well, the reason we don't have this done is because we 
had a 35-day government shutdown this year. That's incredible 
moxie and doesn't get at the heart of this, but I think it does 
get at the heart of what the ultimate problem with IRIS is, and 
that is a bogged-down bureaucratic system that needs to be 
streamlined and fixed. And I hope that you take that into 
consideration. It's meant as positive feedback. I hope that 
it's criticism that requires and produces some real self-
evaluation because I'm still disappointed at the IRIS Program, 
and I'm disappointed at the almost glacial pace that we see in 
change in that program.
    I yield back.
    Chairwoman Sherrill. Thank you. I'd now like to recognize 
Representative Bonamici for 5 minutes.
    Ms. Bonamici. Thank you very much. Thanks to the Chairs and 
Ranking Members and to our witnesses.
    The Environmental Protection Agency should rely on the best 
available independent science to inform Federal policy, and the 
EPA mandate is to protect public health and the environment, 
and that can only be achieved if the EPA is acting on the basis 
of science that's independently verifiable and free from 
political influence, bias from ideology and conflicts of 
interest, and that certainly includes credible assessments of 
the risks posed by chemicals.
    And I've been on this Committee for about 7 years now and 
of course have sat in many hearings, as have many of my 
colleagues, about IRIS over the years. There's no question that 
there is a need for improvement, but what I am hearing today 
and what I am seeing in the recent GAO report I do not consider 
improvement.
    The EPA's Integrated Risk Management System, or IRIS, 
remains distinct from the regulatory programs of the EPA 
intentionally. It's striking that the EPA would consider moving 
away from the robust science and preventing IRIS from 
disclosing its findings to the public. Continued efforts to 
sideline science from the policymaking process at the EPA will 
have chilling consequences for every person in this country who 
benefits from clean air and water and particularly and 
disproportionately young children, seniors, and the health-
impaired.
    Mr. Gomez, in the March 4 GAO report entitled ``Chemical 
Assessment Status of EPA's Efforts to Produce Assessments and 
Implement the Toxic Substances Control Act,'' it outlines that 
in June 2018 EPA leadership in the Office of Research and 
Development instructed the IRIS Program to not release an 
assessment without a formal request from the current leadership 
of a program office. And then ORD instructed the IRIS Program 
to not publicly release any assessment documentation for public 
comment, agency, or peer review while the responses to a survey 
of program and regional offices needs were being compiled. And 
the list then of that--so it's 20 assessments was then reduced 
to three or four chemicals. I'm obviously concerned.
    David Dunlap, a former Koch Industries lobbyist, now serves 
as a Deputy Assistant Administrator for Research and 
Development. These findings of the increased role of ORD in the 
IRIS assessment processes are very concerning.
    So, Mr. Gomez, prior to June 2018, had political leadership 
at ORD ever limited the release of IRIS assessments?
    Mr. Gomez. That is not our understanding.
    Ms. Bonamici. Did the GAO find any other changes to the 
seven-step process that IRIS uses to complete toxicity 
assessments?
    Mr. Gomez. No, we are not aware of any changes at this 
point.
    Ms. Bonamici. Thank you. I want to point out there's just a 
section in the GAO report, page 25, that talks about the calls 
for advice from program office officials represented the first 
time the IRIS Program heard about requests for a prioritized 
list according to the IRIS Program officials since neither the 
program and regional offices nor the IRIS Program had 
information from the Administrator's office about what the 
prioritization was meant to achieve. The IRIS Program was 
unable to provide guidance about what chemicals may be 
considered a priority or how they might be able to continue to 
work on. And then the reduction with no apparent reason, those 
things are documented in the GAO report, very concerning.
    Dr. Orme-Zavaleta, it's my understanding that you oversaw 
the August 2018 survey of program and regional office needs for 
20 assessments. Did you and any other career staff at ORD and 
IRIS have any role during the second round of survey in 
October?
    Dr. Orme-Zavaleta. So once we received some initial 
responses from the programs in response to the August memo, 
there was a conversation the Administrator had with his 
leadership where there was conversation about further 
prioritizing. There was concern that the number of responses 
that came back, which was around 50 or so chemical requests, 
was too large.
    Ms. Bonamici. And what was the basis--did--was that 
explained? What does too large mean?
    Dr. Orme-Zavaleta. I wasn't involved in those discussions, 
so I can't say.
    Ms. Bonamici. Did you ever see the findings from the first 
survey, and are they publicly available?
    Dr. Orme-Zavaleta. So I did receive memos from the response 
of the survey from each of the program offices that responded, 
so yes, I have those, and I believe GAO received those from 
some of them.
    Ms. Bonamici. And the second survey from what I can tell 
from the GAO report was fairly informal, maybe even verbally 
sent. What factors determine the chemicals that were selected 
as priorities from the second survey?
    Dr. Orme-Zavaleta. So for the second survey there was a 
template that was returned back to me that was signed off by 
the Assistant Administrator for those offices. And, again, they 
were asked to respond what were their needs, how are they to be 
used, and when were they needed, and so that was the 
information that was provided back to me, and that included 11 
compounds.
    Ms. Bonamici. My time is expired. I yield back. Thank you, 
Madam Chair.
    Chairwoman Sherrill. Thank you. And now the Chair yields 5 
minutes to Dr. Marshall.
    Mr. Marshall. Thank you so much, Chairwoman.
    I think all my questions are directed to Dr. Orme-Zavaleta, 
so thank you so much for being here. Does IRIS assessment 
include any consideration of actual human exposure or making 
any determination of actual human risk?
    Dr. Orme-Zavaleta. So the--as noted earlier, the IRIS 
Program involves the first two steps of the risk assessment 
process, so it focuses on hazard and then dose response. That 
provides that scientific foundation, which then moves to a 
program office, and their program offices will apply other 
statutory considerations for the programs they implement that 
include exposure and risk characterization.
    Mr. Marshall. I would suppose when you were doing your 
studies--you have four or five studies going at a time on one 
particular substance?
    Dr. Orme-Zavaleta. So in looking at hazard and dose 
response, we look at all available literature that is available 
for that particular chemical, and that can include animal 
information, human information. This is where our systematic 
review process comes into play where it helps to organize and 
synthesize that----
    Mr. Marshall. What do you do when there's conflicting data, 
which I see all the time as a physician. I'll see 20 studies on 
a particular issue and there's usually lots of conflict between 
the studies that I'll read.
    Dr. Orme-Zavaleta. There's a lot of conversation, there's a 
lot of judgment that's employed in going through these 
evaluations, and that's why it's so critical that we have the 
levels of review that we have. So as we look through all of the 
information available in making determinations and judgments 
about hazard and dose response that forms those toxicity----
    Mr. Marshall. And do you share with others, here's the 
studies we looked at and this is why we chose this one over 
that one----
    Dr. Orme-Zavaleta. Yes.
    Mr. Marshall [continuing]. So that's a transparent process?
    Dr. Orme-Zavaleta. Absolutely.
    Mr. Marshall. OK. It looks like to me that sometimes IRIS 
assessments set levels for a chemical below levels that are 
found naturally in the environment, which little Kansas common 
sense to me that doesn't make sense. Do you agree that 
sometimes you set numbers down that are lower than naturally 
occurring in the environment?
    Dr. Orme-Zavaleta. So depending on the chemical and what 
information is available--and so I don't know if you have a 
specific compound in mind, but we'll look at all of the 
available information, and that will feed into our dose-
response assessments that could give a risk level that 
incorporates various levels of uncertainty as well.
    Mr. Marshall. So if we're sitting in this room and we were 
packed here together and whether it's ethylene oxide or 
formaldehyde, whichever one it is, if you're setting levels 
lower than what we measure--do you ever measure what's just 
commonly occurring in the environment and--it just doesn't make 
sense to me.
    Dr. Orme-Zavaleta. So the measurement information is not 
part of the hazard dose-response evaluation. That's what comes 
in with the program offices in looking at exposure and 
determining what the final risk assessment will be. Keep in 
mind IRIS just provides the hazard and dose response and will 
give us a level--a toxicity level for either a cancer or a 
noncancer. Then that goes to a program office who will complete 
the risk assessment process by factoring in exposure and risk 
characterization information and then moves into that 
regulatory context.
    Mr. Marshall. So, you know, as a scientist, do you think it 
would be OK to set a hazard level lower than what occurs 
naturally in the environment at times?
    Dr. Orme-Zavaleta. It's going to be data-driven, and it's 
not going to be done in an ad-hoc way. These assessments go 
through rigorous review within the Agency, between Federal 
agencies.
    Mr. Marshall. Right.
    Dr. Orme-Zavaleta. It opens up for public comment. It goes 
through a rigorous external peer review. And then, as Mr. Gomez 
noted, once we come through and incorporate those comments, it 
goes back through another round of review within the Agency and 
between agencies.
    Mr. Marshall. You know, as a physician, I have to take lots 
of data but eventually have to take some common sense every 
once in a while as well. When I see a study that just makes no 
sense at all to me and they come to a conclusion that I do an 
experiment on that particular medication or treatment plan with 
my patients, so I do hope there's some common sense every once 
in a while.
    Are IRIS assessment cancer classifications representative 
of actual human health risk?
    Dr. Orme-Zavaleta. I'm sorry, can you clarify----
    Mr. Marshall. Yes.
    Dr. Orme-Zavaleta [continuing]. That again?
    Mr. Marshall. Yes. Are IRIS assessment cancer 
classifications representative of actual human health risk?
    Dr. Orme-Zavaleta. So the Agency has cancer risk assessment 
guidelines, and those were last developed in 2005, and that 
lays out different levels of carcinogenicity classification 
based on available information, so--that will include whatever 
information we have from human data as well as animal data or 
other supporting data, and those go into those cancer 
classifications.
    Mr. Marshall. OK. Thank you. And I yield back.
    Chairwoman Sherrill. Thank you. And now the Chair 
recognizes Representative Tonko.
    Mr. Tonko. Thank you to the Chairs and Ranking Members for 
an important hearing.
    The process--or processes through which science is 
conducted, reviewed, or communicated to the public and 
incorporated into policymaking must be transparent. It must be 
free from inappropriate political, ideological, and financial 
and other undue influence. We have seen a disturbing trend at 
EPA lately where science is being sidelined. I'm extremely 
concerned by the actions that have suppressed information and 
kept results hidden from the general public. I am also 
disappointed by recent efforts to hurt the IRIS Program.
    The IRIS Program has reviewed hundreds of chemicals and 
supports programs across our entire Agency. This is an 
important program that keeps us safe. We should not be gutting 
it. We should be ensuring that it has the resources and staff 
to thrive and continue to provide for toxicity information. 
Instead, some here in Congress and in the Administration want 
to give an even louder voice to industry interests that would 
replace unbiased expertise. This would hurt public health and 
is a dangerous endeavor. EPA's priority must be to protect 
public health and our environment.
    So, Dr. Orme-Zavaleta, according to GAO, the Office of 
Children's Health Protection, or OCHP, submitted a lengthy set 
of priority chemicals for the first round of the IRIS survey 
but did not see any of its priorities reflected in the December 
program outlook due to its lack of response during the second 
round. OCHP is a critical EPA office that focuses on the unique 
vulnerabilities facing children from environmental dangers. Our 
children's health should always be a priority, top priority for 
EPA.
    So my question is, was OCHP asked to participate in the 
second round of the IRIS survey along with the other program 
offices?
    Dr. Orme-Zavaleta. They did receive that information to 
participate in the second round and in fact did submit their 
priorities, but it came in after the list and December memo had 
been finalized. You know, that said, as we noted in our 
process, an office can identify or nominate a new assessment 
need at any time, and we'll have another formal round of 
requests coming later this summer.
    Mr. Tonko. Can you explain the timing? And was it a 
coincidence that OCHP submitted its list precisely when it was 
too late to include them?
    Dr. Orme-Zavaleta. So I was not involved in the further, 
the second phase of that prioritization process. I'm not aware 
of what particular timeframe was identified. Again, I was 
informed of here was the list and then I released memos and----
    Mr. Tonko. But there was no--no one shared a prior history 
with you about----
    Dr. Orme-Zavaleta. I was not involved in those 
conversations.
    Mr. Tonko. What chemicals did OCHP include on its second 
round priority list of three to four chemicals? And was 
formaldehyde one of those chemicals?
    Dr. Orme-Zavaleta. I believe formaldehyde was one of those 
chemicals, but we can get back with you. I don't recall the 
full list.
    Mr. Tonko. And does ORD consider the protection of 
children's health a priority? And if so, why did it not make 
more of an effort to include OCHP's request in the final list 
of IRIS chemicals?
    Dr. Orme-Zavaleta. So we consider--so we are a supplier of 
science to the Agency's programs that use that information, and 
so as far as children's health programs, yes, we do consider it 
vitally important, and we help to sponsor some research at the 
children's health centers, along with NIEHS. Again, with the 
particular process I was not involved in that and did not 
receive the final input until early December.
    Mr. Tonko. Can you imagine how they could have made more of 
an effort to include OCHP's request?
    Dr. Orme-Zavaleta. I think that's something that we can 
think about going forward.
    Mr. Tonko. But nothing constructive that you would offer 
this panel today?
    Dr. Orme-Zavaleta. No, not at this point.
    Mr. Tonko. Mr. Gomez, GAO's findings reveal a disturbing 
level of political interference with IRIS. If political 
appointees inside EPA are excluding the EPA career staff from 
key decisions, it raises a host of concerns about whether those 
appointees can be trusted to do the right thing for IRIS and 
the public. Was GAO able to determine who inside EPA made the 
decision to conduct a second round of the IRIS priority survey? 
And who decided to limit that round to three to four chemicals 
per program office?
    Mr. Gomez. So that's something we do not have clear 
information on, so as we reported it was our understanding that 
something was done early to limit them, but we don't know. What 
we do know, though, is that we do have responses from some of 
the offices that did submit it in the second round saying these 
are our three and four chemicals.
    Mr. Tonko. OK. I am out of time, so I will yield back, 
Madam Chair.
    Chairwoman Sherrill. Thank you. The Chair now recognizes 
Representative Bird--Baird, sorry.
    Mr. Baird. Thank you, Madam Chair. I appreciate the 
witnesses being here today.
    My question really goes to Dr. Orme-Zavaleta, and that has 
to do with the fact that Mr. Gomez mentioned a seven-step 
process for chemical assessment development recognition, and so 
in that process there's a draft of IRIS assessments, and 
they're circulated internal to the EPA and to the region for 
review. So how are those comments and concerns resolved? And 
then once they've been submitted for review, then how do they 
resolve those concerns and questions?
    Dr. Orme-Zavaleta. So the IRIS Program has regular 
communications with program and regional representatives. I 
think they may meet even monthly. And as comments and questions 
come in, there are conversations with the full group to sort 
through and resolve those particular comments, and then that 
moves onto the next phase.
    Mr. Baird. So I guess you're saying as those come in, if 
they're valid and reviewed, then they are incorporated in with 
the process and----
    Dr. Orme-Zavaleta. And there is a conversation between the 
IRIS staff and the program representatives, as well as regional 
representatives on addressing those comments.
    Mr. Baird. A second part of that question, I understand the 
interagency science review formally was coordinated by the OMB 
(Office of Management and Budget), but how is that review 
currently coordinated?
    Dr. Orme-Zavaleta. The interagency science review process 
was revised in 2009 to be entirely managed and coordinated by 
EPA. OMB is a participant in the interagency science review 
process, along with other agencies and White House offices.
    Mr. Baird. OMB? OK. Mr. Gomez, I have a couple of questions 
for you. It was noted that the IRIS officials have implemented 
systematic review. Do we have any current documentation that 
would suggest guidance on how this systematic review takes 
place on this process?
    Mr. Gomez. So--and this is also something that Dr. Orme-
Zavaleta can elaborate on. But systematic review is something 
that's been in place in EPA for a while. They have started also 
to use the software that allows them actually to do this 
faster. So, yes, we are aware that this is something that the 
IRIS Program is using. It is something that--that's good. In 
fact, I think maybe on your second panel there's someone that 
is even an expert on systematic review or knows a lot more 
about it.
    Mr. Baird. Thank you. One more question in that regard. To 
your knowledge, what specific IRIS assessments completed since 
2014 have demonstrated full of implementation of the EPA IRIS 
system review process, any idea?
    Mr. Gomez. So, I'm sorry, you're asking how many have been 
released and went through the whole process?
    Mr. Baird. And completed the whole process----
    Mr. Gomez. Yes.
    Mr. Baird [continuing]. Since 2014.
    Mr. Gomez. Perhaps Dr. Orme-Zavaleta might know. I don't 
think there's been many. I think there was one that was 
released recently.
    Dr. Orme-Zavaleta. While RDX was released recently (August, 
2018) it does not represent full implementation of the IRIS 
systematic review process. Because the assessment was already 
in development when the 2011 NAS recommendations were released, 
the final assessment reflects early implementation in the 
programmatic adoption of the NRC recommendations.
    Mr. Baird. Thank you, and I yield back my time.
    Chairwoman Sherrill. Thank you, Mr. Baird. The Chair now 
recognizes Representative McAdams.
    Mr. McAdams. Thank you, Madam Chair.
    I have a question for Dr. Orme-Zavaleta. Press reports and 
Senate testimony from then-EPA Administrator Scott Pruitt 
indicate that the IRIS formaldehyde assessment has been ready 
for public release since 2017, since the end of 2017, and that 
the assessment establishes a link between formaldehyde exposure 
and leukemia. Formaldehyde did not appear on the December 2018 
list of IRIS priority chemicals, and the GAO report indicated 
that its future is unknown. So my question is what is the 
status of the formaldehyde assessment, and when can we expect 
it to be released for public comment?
    Dr. Orme-Zavaleta. So we do have a draft formaldehyde 
assessment, and with TSCA recently announcing that formaldehyde 
is in their top 20, we're going to be having conversations with 
our Office of Chemical Safety and Inclusion Prevention to 
determine next steps in going forward. We feel that the 
assessment that we have will be--will help with that TSCA 
determination, and we need to determine next steps for 
supporting the other Agency needs.
    Mr. McAdams. So along those lines, why was the 
formaldehyde--why was formaldehyde left off the list of--the 
new list of IRIS priority chemicals, and who made that decision 
to leave it off?
    Dr. Orme-Zavaleta. So each program office made their 
decisions on what were their priorities, how they were going to 
use it, and when they needed it, and so I wasn't involved in 
those conversations. Again, the programs help provide the 
priorities, and then our responsibility is implementing those 
priorities and providing the best science available.
    Mr. McAdams. So who would've made the decision to not 
include formaldehyde on that list?
    Dr. Orme-Zavaleta. So that was through the program offices, 
and the requests that I received were signed off at the 
Assistant Administrator level.
    Mr. McAdams. So--and just last week EPA announced that it 
would designate formaldehyde a high-priority chemical under the 
Toxic Substances Control Act. How can formaldehyde be 
simultaneously a high-priority chemical under TSCA and not a 
priority at all for IRIS?
    Dr. Orme-Zavaleta. So I wouldn't say that it's not a 
priority for IRIS. We have not discontinued that work, and that 
information is going to be leveraged in helping to support TSCA 
moving forward, but there's going to be more conversations to 
follow on our next steps.
    Mr. McAdams. Thank you. One question for Mr. Gomez. Can you 
explain what you meant when you wrote in your testimony that 
the absence of the formaldehyde assessment, quote, ``could 
create confusion for stakeholders?''
    Mr. Gomez. Right, so I think that there are stakeholders 
that were expecting to see that assessment and may in fact have 
use for it, and so now that it's not on the final list, I think 
there are questions about what happened to it, as you were 
asking, and where--when is it going to be released.
    Mr. McAdams. All right. Thank you. I yield back.
    Chairwoman Sherrill. Thank you, Mr. McAdams. Now, the Chair 
recognizes Representative Babin.
    Mr. Babin. Sure, thank you. Thank you, Madam Chair.
    Mr. Gomez, in your review of the IRIS Program, you rely in 
part on the 2018 NAS report to find that the IRIS Program has 
made significant progress. This 2018 NAS review was simply, if 
I understand it, a check-the-box exercise organized by career 
program officials confirming that changes have been made to the 
program. In other words, the NAS review did not examine any 
IRIS products to ensure proper scientific rigor. It did not 
identify any tangible outcomes as a result of the changes made 
to the program. Did GAO identify any of these shortcomings 
after using the 2018 NAS review as a primary source for praise 
of the program?
    Mr. Gomez. So perhaps what I can do is just explain the 
approach that we take in looking at the progress that the IRIS 
Program is making. So while we do look at other reports that 
are out there like the NAS study that you mentioned, we're 
looking at a couple of criteria, so we're looking at whether 
there is leadership commitment, you know, does the program have 
the capacity to do the work, do they have a plan in place to do 
the work, are they monitoring how well they're doing, and are 
they also demonstrating progress? So we look at all of those 
elements to then come up with a rating, and for the IRIS 
Program in particular, as we've been discussing, they have made 
some progress, so we are giving them the rating of partially 
met, so they're not fully met, and that is why it's still on 
the High-Risk List for GAO, and we're continuing to look at it.
    But we are concerned, as others, about the length of time 
that it takes to issue these assessments, and so timeliness is 
an area that has a lot of attention.
    Mr. Babin. OK. Thank you. And then, Dr. Orme-Zavaleta, I 
see the Administration has taken steps to prioritize chemicals 
for assessment in the IRIS Program. Would you classify this as 
a positive step for IRIS?
    Dr. Orme-Zavaleta. I do. I think we have always gone out to 
programs in helping to identify what their needs are, but this 
new process raises it to the Assistant Administrator level, and 
that's going to help provide greater stability to the program, 
as well as greater accountability not only to the program 
offices and reminding them that they made this request but also 
in helping us in meeting those particular requests.
    Mr. Babin. OK. Thank you, and I yield back, Madam Chair.
    Chairwoman Sherrill. Thank you. The Chair now recognizes 
Representative Beyer.
    Mr. Beyer. Thank you, Madam Chair.
    Mr. Gomez, one of the main concerns I have reading the GAO 
report is that, you know, the IRIS, which we've talked about 
for many years on this Committee, is just far too important to 
allow chemical assessments to be decided by anything short of a 
transparent, collaborative process that listens to the voices 
of the career staff.
    So in reading the GAO report, you talked about how the 
ORD's second request is made verbally at a meeting, including 
direction to the program offices to limit their request to no 
more than three to four chemicals. Did ORD explain to you why 
it was appropriate to do this directive verbally and with no 
prior consultation and not through a documented process?
    Mr. Gomez. No, sir, we don't have any additional 
information as to any additional guidance that was provided as 
to how they should further limit those assessments.
    Mr. Beyer. OK. And then, Dr. Orme-Zavaleta, I know you've 
read all this carefully. Does it make any sense to you that ORD 
proceeded to a second round of the survey with no involvement 
from IRIS leadership?
    Dr. Orme-Zavaleta. So the conversation that took place was 
a meeting that the Administrator has weekly with his senior 
leadership, the Assistant Administrators, and so I was not 
there, I was not involved in that particular conversation. I 
don't know how the request was made. I don't know the 
conversation that ensued.
    Mr. Beyer. Mr.--thank you. Mr. Gomez, did GAO--you know, we 
talked a lot about how the shrinking from 22 subject chemicals 
down to 11, and this is part of the prioritization process. Was 
there any evidence that IRIS was incapable of handling the 
previous largest--larger workflow?
    Mr. Gomez. As we understand it, the IRIS Program was able 
to handle that workload given their current resources.
    Mr. Beyer. And we certainly heard from--based on the 
questions from any of the other people on the panel that there 
were chemicals left out of that.
    Dr. Orme-Zavaleta, and again, I know this wasn't in your 
decisionmaking, but when did ORD decide to reduce the number of 
priority chemicals by so much? And, you know, one of the 
criticisms again that shows up in the GAO report was there 
was--there's no information at the EPA Administrator's office 
about what the prioritization was meant to achieve.
    Dr. Orme-Zavaleta. So, again, I wasn't involved in that 
conversation. I don't know that it was requested by the ORD 
representative or by the Administrator.
    Mr. Beyer. You know, the suspicious part of me wonders if 
the prioritization wasn't simply used as a way to eliminate 
chemicals that are controversial within industry and focus on 
ones that are easy, low-hanging fruit, for example, 
formaldehyde, which raises the prospect that this is not 
science driving it but rather politics and money, so----
    Dr. Orme-Zavaleta. So, again, I wasn't there, but if you'd 
like further information, we can go back to staff and respond 
back.
    Mr. Beyer. OK. Great. Thank you very much. Mr.--Madam 
Chair, I yield back.
    Chairwoman Sherrill. Thank you. The Chair now recognizes 
Dr. Foster.
    Mr. Foster. Thank you. I appreciate it, and I appreciate 
being allowed to serve on this--in this hearing, although I 
don't actually serve on the Committee.
    I'd like to bring up the issue of ethylene oxide. 
Willowbrook, Illinois, in my district is home to a 
sterilization facility that's used ethylene oxide for decades 
to sterilize medical equipment. And this community has 
unfortunately become an example of the important role that the 
EPA plays in defending public health and what can happen when 
these systems don't do as well as they should.
    In the case of ethylene oxide, there was roughly a 15-year 
gap between the publication of scientific papers that indicated 
ethylene oxide was a far more powerful carcinogen than had 
previously been assumed and the corrective actions and eventual 
shutdown of that facility in my district that was venting 
apparently unsafe amounts of ethylene oxide into nearby 
neighborhoods.
    And I request unanimous consent to insert into the record 
the Executive Summary of the EPA's Evaluation of the Inhalation 
Carcinogenicity of Ethylene Oxide into the record.
    Chairwoman Sherrill. Without objection.
    Mr. Foster. Thank you. And so Dr.--oh, boy--Orme-Zavaleta--
--
    Dr. Orme-Zavaleta. Jennifer.
    Mr. Foster. Jennifer, you know, what would the reasons have 
been for a 15-year delay in the scientific findings and the 
actual actions? You know, are these things limited by just a 
shortage of manpower? You've got tens of thousands of chemicals 
and you have to prioritize your effort and you just don't have 
enough people on this, or is this a situation where there's a 
lot of pressure from industry that's delaying--causing a 15-
year delay of this kind?
    Dr. Orme-Zavaleta. Yes, so I'm not exactly clear on--you're 
thinking of the timeframe. IRIS provided an assessment for 
ethylene oxide in 2016.
    Mr. Foster. Correct. And all the references in that were 
scientific papers dating from the late 1990s, early 2000s.
    Dr. Orme-Zavaleta. So, you know, I think that that's 
something I can take back to staff and we can get further 
information on how additional information can be incorporated, 
but the assessment that was published in 2016 went through--
it's a very complex chemical, a lot of intricacies in trying to 
evaluate those risks.
    Mr. Foster. Simple chemical but with complex biological 
effects.
    Dr. Orme-Zavaleta. There you go. And so in going through 
the reviews, it went through two rounds of review with our 
Scientific Advisory Board, which is not always common, but a 
very rigorous, thorough review, as well as reviewed through the 
different Federal agencies and within EPA, so it's a very solid 
assessment, and it's one that we continue to support, and 
that's part of our responsibility----
    Mr. Foster. I understand. It just would have been nice if 
it would have been faster----
    Dr. Orme-Zavaleta. Yes.
    Mr. Foster [continuing]. Than 15 years. And I was just 
wondering if this is a--I guess the point of my question is if 
this is a manpower-limited thing, then I think there is an 
argument to be made to just increase the manpower available so 
this situation doesn't happen because you can mess up either 
way. You know, there are people panicked selling their houses, 
and if it turns out the best scientific indications are that is 
unnecessary, then, you know, mistakes have been made in that 
direction. And of course there's the danger of damage to human 
health.
    And so if you could actually have a look at that specific 
case and see to what extent if you had--were not manpower 
limited----
    Dr. Orme-Zavaleta. Yes, we'll be glad to follow up.
    Mr. Foster [continuing]. Whether--what that timescale could 
have been compressed to be.
    Dr. Orme-Zavaleta. Sure.
    Mr. Foster. And also if you could come up with a best 
estimate of the number of people, you know, who will--you know, 
assuming that the report stays valid, a best estimate of the 
number of people, additional cancer cases nationwide due to 
that delay and particularly the avoidable part that might be 
avoided with more investment in manpower.
    And just more generally does the EPA or any third party 
maintain estimates of the cumulative number of lives saved by 
EPA actions?
    Dr. Orme-Zavaleta. So I think that's something I'll also 
have to follow up on. There are evaluations that are not 
necessarily conducted within ORD but other parts of the agency 
that looks at impact analyses, and so that's something we can 
follow up on.
    Mr. Foster. Yes. It would be a very good thing to do. Also, 
the cumulative costs because your actions impose costs on 
industry, and they save human lives, and seeing those two 
numbers side-by-side, both cumulatively and for specific 
actions, I think would clarify a lot of the thinking that--and 
certainly we tend to talk past each other when we are only 
looking at one side of it in this Committee in the past----
    Dr. Orme-Zavaleta. OK.
    Mr. Foster [continuing]. And that would allow you of course 
to look at the number of lives saved per dollar of cost, which 
is a very tough thing to talk about in politics, but really, 
you know, that's I think one of the lenses that we have to look 
at this through. And particularly in cases where the actions 
are delayed because of manpower limitations that might allow us 
to think about whether an investment here--to quantify whether 
an investment in increased manpower would save a, you know, 
roughly quantifiable number of human lives. So if you do get 
back with those. And if it turns out that you don't have those 
estimates, come up with a scope of a congressional request to 
get those numbers reported. I think it would clarify our 
thinking greatly.
    And thank you. I see my time is up, and I yield back.
    Chairwoman Sherrill. Well, thank you very much. Thank you 
to Dr. Orme-Zavaleta and Mr. Gomez for your testimony today. 
We'll now have a short break while we seat our next panel of 
witnesses. Thank you, everyone.
    [Recess.]
    Chairwoman Sherrill. Welcome back. At this time I would 
like to introduce our second panel of witnesses. Dr. Bernard D. 
Goldstein is a Professor Emeritus and Dean Emeritus at the 
University of Pittsburgh, Graduate School of Public Health; Dr. 
Ivan Rusyn, a Professor with the Department of Veterinary 
Integrative Biosciences at Texas A&M University, and the Chair 
for the Interdisciplinary Faculty of Toxicology. He also serves 
as the Director of the Texas A&M Superfund Research Center.
    Dr. Julie E. Goodman is a principal at Gradient, an 
environmental and risk sciences consulting firm with a focus on 
workplace and environmental chemicals.
    And our final witness, Ms. Wilma Subra. Ms. Subra is the 
Founder and President of Subra Company, Inc., an environmental 
consulting firm in New Iberia, Louisiana. She also serves as a 
Technical Advisor to the Louisiana Environmental Action 
Network.
    Dr. Goldstein, you are recognized for 5 minutes.

             TESTIMONY OF DR. BERNARD D. GOLDSTEIN,

             PROFESSOR EMERITUS AND DEAN EMERITUS,

               UNIVERSITY OF PITTSBURGH GRADUATE

                    SCHOOL OF PUBLIC HEALTH

    Dr. Goldstein. Chairwoman Sherrill, Chairwoman Fletcher, 
and distinguished committee Members, I appreciate the 
opportunity to speak in front of this Committee again. To keep 
the time, I will focus on the core principles of why IRIS was 
developed and its relevance to today. It's not just my age that 
permits me to look back this far. I was Assistant Administrator 
for Research and Development appointed by President Reagan 
working under Administrators Ruckelshaus and Lee Thomas as IRIS 
was under development.
    My conclusion regrettably is that rather than streamlining, 
disemboweling is really what is happening here. We are 
destroying the current long-term scientific basis for how EPA 
functions. My background is detailed in my written testimony. I 
want to emphasize that through the years, I've worked closely 
with industry. In my current consultant work in toxic tort 
cases I have about equally an expert defending an industry as I 
am an expert for the plaintiff side suing the industry, and it 
depends upon the facts of the case.
    So why was IRIS developed? In 1983, soon after the NAS Red 
Book was released, I became EPA's Assistant Administrator for 
Research and Development. First, generally not known now, but 
EPA was already doing risk assessments. The problem was that 
the silo structure that characterized the EPA then and now made 
risk assessments a shambles. Now, this will occur again if 
assessments are removed from EPA's science offices to program 
offices. Different default assumptions were a key issue.
    Administrator Ruckelshaus recognized that for risk 
assessment to be useful, it needed to be sufficiently 
standardized and transparent so that, in his words, it would 
not be like beating a spy to get whatever answer you wanted. 
External transparent peer review is recognized as being 
crucial.
    And yet another reason for centralized ORD-led approaches, 
which I haven't heard discussed, is the obvious budgetary 
consequences because risk became--assumed a major role in 
assigning agency priorities. The program offices might want to 
increase the risk for air as opposed to water or water as 
opposed to air if, in fact, they are the ones allowed to have a 
say in what the basic approaches were.
    Subsequently, other important roles for IRIS have been 
recognized. The local purposes, which I'm glad to hear both 
Chairwomen describe--I recently had a paper--a document from 
the Allegheny County Health Department responding to a concern 
of local community, gentrifying community about some old 
industries there. It relied heavily on the IRIS process. It 
relied heavily on IRIS numbers, which were duplicated in this 
document.
    There's also a need to be responsive to national concerns 
that in a sense help us with world trade issues. We have 
something that's recognized worldwide in IRIS. If we politicize 
it, we will no longer be able to look back and expect other 
countries to use it because it'll be seen as a politicized 
effort rather than the science that it now is.
    And we need a centralized science--we need a centralized 
IRIS within ORD to decide whether and how to incorporate new 
science. And there is much new science related to hazard, 
related to dose response that has to be incorporated.
    It should be clear, Administrator Wheeler's decision to cut 
IRIS' budget, withhold its assessments from peer review, and 
move the formaldehyde issue is quite a contradiction of these 
founding principles.
    So let me conclude by saying that I have the deepest 
respect for Dr. Orme-Zavaleta--and I do call her Jennifer. I 
think she's doing really extremely well under the 
circumstances. But as the appointee of President Reagan 
confirmed by the U.S. Senate, I would have resigned had 
Administrator Ruckelshaus or Administrator Thomas tried to do 
the things that are happening now.
    I cannot recommend that the current AA of ORD resign; there 
is none, nor in the third year of this Administration even are 
rumors to whose name might be sent to the Senate. And it is 
unlikely that any reputable scientist would accept such a 
nomination.
    I would welcome answering questions about my overall 
written testimony, including transparency, about which I have 
previously testified in front of this Committee and about 
formaldehyde, which, as a hematologist and toxicologist, I've 
long been involved with. Thank you.
    [The prepared statement of Dr. Goldstein follows:]
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    Chairwoman Sherrill. Thank you very much.
    Dr. Ivan Rusyn, you are now recognized for 5 minutes.

                  TESTIMONY OF DR. IVAN RUSYN,

         PROFESSOR, DEPARTMENT OF VETERINARY INTEGRATIVE

              BIOSCIENCES; CHAIR, INTERDISCIPLINARY

              FACULTY OF TOXICOLOGY; AND DIRECTOR,

        SUPERFUND RESEARCH CENTER, TEXAS A&M UNIVERSITY

    Dr. Rusyn. Thank you. Chairwoman Sherrill, Chairwoman 
Fletcher, distinguished Members of the Subcommittees, I'm 
honored to appear before you today for this hearing.
    As a matter of disclosure pertaining to the topic of 
today's hearing, I'm currently chairing a workshop committee of 
the National Academies to support development of EPA's IRIS 
toxicological review. However, I appear before you today 
representing my own perspectives, not those of the Academies or 
the Texas A&M University.
    I would like to offer insights from my role as a researcher 
in the field of toxicology and a person with understanding of 
the process of developing human health assessment in general 
and those of the IRIS Program in particular. I have more than a 
decade of service as peer reviewer of various IRIS assessments, 
including 2011 Review of the EPA's Draft IRIS Assessment of 
Formaldehyde. I also served as a faculty fellow to the IRIS 
Program for 2 years where I interacted with IRIS staff in a 
variety of scientific methodological issues directly relevant 
to implementation of the advice from the National Academies. My 
laboratory is funded by the NIH (National Institutes of 
Health), the EPA, the National Academies, California EPA, and 
the European Petroleum Refineries Association.
    With respect to the Committee's interest in the role that 
IRIS plays in the field of chemical toxicity assessment, I note 
that it is difficult to overstate the importance of the IRIS 
Program to the protection of public health in the United States 
and abroad. Both the National Academies and the EPA themselves 
acknowledged the key role that IRIS-produced assessments play 
in many risk management decisions and superfund site cleanup.
    IRIS values are relevant for protecting the health and 
well-being of everyone, not only those who may be exposed in 
the workplace and not only by a narrow choice of the routes of 
exposure. As such, IRIS values are held to the highest standard 
in terms of the quality of their assessments, undergo 
exhaustive intra-government and external reviews, and the 
process generates very important and widely used toxicity 
values and classifications.
    With respect to the Committee's interest in the progress 
IRIS has made addressing recommendations from the National 
Academies, I note that a 2011 NRC (National Research Council) 
report: Review of the EPA's Draft IRIS Assessment of 
Formaldehyde offered a roadmap for the overall changes of the 
process, as well as some specific guidance. And the report did 
recognize that this process may take time and that EPA is fully 
capable of implementing suggested improvements, hence no delay 
in releasing other assessments was recommended.
    Two subsequent committees of the National Academies weighed 
in on the process and progress and have commended the IRIS 
Program for the work that they're doing. I fully agree with the 
conclusions of those reports.
    Overall, it is my opinion that substantial improvements in 
the IRIS process have been made in a relatively short period of 
time, and it is clear that the IRIS Program welcomed the advice 
it had been receiving from the National Academies and other 
stakeholders. The IRIS Program fully embraced the concept of 
systematic review. Systematic review is neither easy, nor it is 
straightforward, and the IRIS Program is to be commended for 
their leadership in this area.
    Also, a number of strategic decisions were made by IRIS to 
develop specific guidance documents and further standardize the 
process. A number of software solutions have been implemented, 
and investments in staff training and improvements to the 
interactions with outside stakeholders were made.
    It is disconcerting to me, however, that it appears that 
the IRIS Program lacks the support from the leadership of the 
EPA in terms of providing it with sufficient financial 
resources and adequate staffing. It has been stated in the 2019 
GAO report discussed this morning that a number of recent 
events may have grave consequences to the ability of the IRIS 
Program to continue implementation of the advice from the 
National Academies to complete their draft assessments and to 
set further priorities commensurate with the needs of other 
offices at the EPA and of their other stakeholders. These 
developments are troubling, and I encourage the Subcommittees 
to look into the GAO report's facts and conclusions and to 
determine whether EPA may need to support and strengthen the 
IRIS Program, as suggested by the National Academies.
    In conclusion, it is my opinion that the IRIS Program has 
implemented the recommendations of the National Academies. The 
IRIS Program should be supported with adequate financial 
resources and staff. I also support strengthening the oversight 
by Congress of the implementation of the Frank R. Lautenberg 
Chemical Safety for the 21st Century Act.
    Thank you for the opportunity to appear in this hearing, 
and I'd be happy to answer any questions the Members might 
have.
    [The prepared statement of Dr. Rusyn follows:]
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    Chairwoman Sherrill. Thank you very much.
    Dr. Goodman, you're now recognized for 5 minutes.

               TESTIMONY OF DR. JULIE E. GOODMAN,

                       PRINCIPAL, GRADIENT

    Dr. Goodman. Thank you very much for the opportunity to 
speak today. I am Dr. Julie Goodman, an epidemiologist and 
board-certified toxicologist at Gradient, an environmental 
sciences consulting firm. We assist public and private 
organizations in evaluating the risks of chemicals and other 
substances to human health and the environment.
    I have been developing and applying weight-of-evidence and 
systematic review methodology for over 10 years in a variety of 
settings, and I taught a graduate-level class on this topic at 
Harvard University. Much of my work has been published in the 
peer-reviewed literature. I'm presenting testimony today as an 
independent scientist. While my travel costs have been paid by 
my company, I'm here today on my own time and I am not being 
compensated for the time I spent preparing this testimony.
    As you heard earlier, in 2011, a National Academy of 
Sciences or NAS committee provided recommendations for the IRIS 
Program in the context of a review of formaldehyde. In 
response, EPA released a draft handbook for IRIS assessments in 
2013, and then in 2014 and 2018, NAS reviewed and evaluated the 
IRIS assessment process more generally, including progress made 
since 2011.
    Both the 2011 and 2014 NAS reviews stated that the IRIS 
Program lacked a clear conceptual framework and clear and 
transparent methods. Further, NAS concluded that EPA did not 
fully assess the weight of evidence or justify the selection of 
studies for the derivation of toxicity values. The 2014 NAS 
review also specifically called for the finalization of the 
draft IRIS handbook.
    Since that time, EPA has made substantial improvements to 
the IRIS process, including the development and application of 
systematic review methods for evidence identification, 
evaluation, and integration, but not all of the identified 
issues have been resolved.
    To date, EPA has shown progress on a chemical-by-chemical 
basis using the IRIS Assessment Plans for uranium and ammonia 
and systematic review protocols for chloroform and chromium 
assessments as examples of its new portfolio approach. EPA 
announced it will move forward with a revised handbook, which 
will be put through peer review and public comment processes 
this year. This is undoubtedly needed and a critically 
important step forward, and EPA is to be commended for these 
actions.
    I note that while it is true that a one-size-fits-all 
protocol for all chemicals is not feasible, and details of the 
individual chemical assessments will vary based on the specific 
research questions identified and on the available data, all 
IRIS assessments will benefit from a clearly written framework 
that serves as a standard operating procedure, or SOP, for 
agency systematic reviews. The SOP can be expanded to include 
chemical-specific tailoring as needed to each phase of specific 
chemical reviews. An iterative approach can be used to 
incorporate new issues and knowledge into the SOP as it becomes 
available.
    To follow through on its intention to use systematic review 
and weight-of-evidence methodology for hazard identification, 
EPA needs to complete an individual assessment using the new 
process. My experience with developing these types of 
approaches has shown that it is important to apply a framework 
in a chemical-specific setting to determine where its strengths 
lie and where it falls short and should be revised.
    IRIS assessments both identify hazards associated with 
chemicals and characterize these hazards by generating toxicity 
values. With regard to the latter, EPA is always limited to 
studies with sufficient data for dose-response analysis, so the 
handbook should describe what will be done if these studies are 
not reflective of the science as a whole.
    In addition to studies that identify toxic effects, part of 
the hazard identification process is to consider studies that 
inform the mechanism of toxicity. EPA should indicate how it 
will consider this mechanistic evidence when deriving toxicity 
values. For example, if mechanistic studies clearly show a 
threshold effect, then it should be incorporated into the dose-
response analysis, and linear low-dose extrapolations should 
not be applied.
    Now, there's no doubt that conducting systematic reviews 
takes more time and resources than nonsystematic reviews. 
However, a completed handbook that can and should be revised to 
reflect the best-available science will go a long way toward 
expediting assessments and increasing transparency and 
consistency across assessments. More importantly, with an 
established standard procedure in place, EPA staff will have 
better guidance to conduct IRIS assessments in a systematic and 
unbiased manner. This will allow stakeholders and members of 
the public to better understand the process and provide input 
and ultimately will increase their confidence in EPA's 
assessments.
    In conclusion, to address the NAS recommendations for the 
IRIS Program dating back to 2011, EPA needs to complete a 
general guidance framework for IRIS assessments and a revised 
handbook. EPA also needs to complete assessments that both 
apply this guidance and demonstrate that dose-response analyses 
and toxicity value derivations will be informed by the overall 
weight of evidence and biological mechanisms. Thank you very 
much.
    [The prepared statement of Dr. Goodman follows:]
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    Chairwoman Sherrill. Thank you. Ms. Subra, I now recognize 
you for 5 minutes.

                    TESTIMONY OF WILMA SUBRA,

                   PRESIDENT, SUBRA COMPANY;

                     AND TECHNICAL ADVISOR,

             LOUISIANA ENVIRONMENTAL ACTION NETWORK

    Ms. Subra. Thank you, Madams Chairwomen and distinguished 
Members of the Subcommittees for the opportunity to testify 
here today. I have provided technical assistance to community 
groups throughout the United States and in some foreign 
countries dealing with environmental and human health issues 
for more than 52 years.
    From the beginning of the publication available through 
IRIS assessment program, the information provided by IRIS has 
been extremely valuable in identifying health hazards of 
chemicals and evaluating exposure situations in the impacted 
communities. The toxicological information provides a complete 
evaluation of each chronic pathway of exposure and resulting 
risk. This information is critical in providing community 
members accurate and focused exposure and risk information per 
chemical.
    No matter what the situation, impacted community members 
are never exposed to just a single chemical. Focused on only 
one chemical or contaminant results in the underestimation of 
exposure, risk, and associated health. Community members' risk 
has to be included in all chemicals, all pathways of exposure, 
and all concentrations in all media in order to adequately 
identify the risk and develop pathways moving forward.
    When we look at the impacts of formaldehyde, formaldehyde 
is a precursor to many other chemical compounds produced by 
industrial facilities. In Louisiana, we have 31 major 
industrial facilities with more than 13 million pounds of 
formaldehyde being released into the environment each year. In 
Texas, we have 77 major industrial facilities releasing more 
than 819,000 pounds of formaldehyde into the environment each 
year. In the United States, we have 727 major industrial 
facilities releasing 19 million pounds into the environment.
    So an example of some of the communities that have been 
impacted by formaldehyde, the work I've done, in Natchitoches, 
Louisiana, there's a plywood mill. The citizens around the 
facility were very ill. We did air samples to determine that 
formaldehyde was the major toxic component. We went in and met 
with the company that was making the plywood and determined 
that they were using a formaldehyde-based glue or resin. 
Working with the community and the industry, they changed the 
kind of resin or glue that they were using, and therefore, the 
health impacts of the community were much improved.
    Then we have a Georgia-Pacific facility in Crossett, 
Arkansas. It has a pulp mill, it has a paper mill, and it has a 
chemical mill. The chemical mill actually makes the 
formaldehyde for use at all three facilities. The citizens 
complained of two things: Air emissions, odors of hydrogen 
sulfide, and formaldehyde. Hydrogen sulfide is the most 
disruptive to their health, but formaldehyde is the most toxic.
    Based on all the work with the citizens, we convinced EPA 
and they brought in the National Enforcement Investigation 
Center, which identified that the emissions of formaldehyde 
were being missed by the facility because they were using the 
wrong kind of detector to do their leak detection and repair. 
So, as a result of that, they issued them all sorts of 
violations and then in December of last year there came the 
penalty notice where they required them to pay $300,000 for 
each agency, that State agency and the Federal agency. They 
required them to do $1.2 million in restitution and $1 million 
over 3 years for supplemental environmental projects. These 
were all reduced emissions of the toxic chemicals, primarily 
formaldehyde.
    Then we have a self-help group that does housing for 
disadvantaged people. They were looking at changing to a 
contractor that build the houses and would put it on their 
lots. As it turned out, they were using a resin that had 
formaldehyde in it. We had conversations with them. They 
declined to change the kind of resin they were using. 
Therefore, the self-help group no longer even considered having 
those houses because they didn't want their environmental 
justice community members exposed.
    And then finally, we had the hurricanes of 2005, Katrina 
and Rita, a huge impact to Louisiana, Mississippi, Alabama, and 
Texas. And, as a result, we found out by doing sampling with 
Sierra Club that a large number of people were living in the 
FEMA (Federal Emergency Management Agency) trailers that were 
provided that had huge emissions of formaldehyde. We did 32 
tests in one set. Thirty exceeded EPA's criteria for 
formaldehyde, 44 tests and 40 exceeded. As a result of that, 
120,000 families were estimated as living in FEMA trailers with 
formaldehyde over the acceptable level. And in a FEMA trailer, 
it's an enclosed environment. Emissions into the air, everyone 
in the families are impacted. And so that was a situation where 
you did good for the community members but resulted in health 
impacts to those community members. And a large number of them 
were children and pregnant females.
    [The prepared statement of Ms. Subra follows:]
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    Chairwoman Sherrill. Thank you. Thank you. Well, thank you 
to all of our witnesses. At this point we'll begin our first 
round of questions. The Chair recognizes herself for 5 minutes.
    So, Dr. Goldstein, in your testimony you spoke about the 
state of EPA chemical assessments prior to the establishment of 
IRIS. Can you please elaborate on the impetus to establish the 
IRIS Program and what needs it was filling that program offices 
were unable to address?
    Dr. Goldstein. Yes, the--IRIS to me was always a--sort of a 
smooth just continuation of the description of what I gave 
under Administrators Ruckelshaus and Thomas. How to name it was 
lots of debate. I remember one of the original ideas was the 
Coordinated Risk Assessment Program, but the acronym served to 
be of no value.
    The issue of how to move forward for EPA always came down 
to the natural tension between the program offices and a 
central administrative type of structure as the Office of 
Research and Development. And through the years that has just 
progressed. So it was just a building onto the issue of we need 
a centralized approach, the Administrator has to understand 
what the relative--what risk means to priorities and prioritize 
among the various problems that the Administrator was facing in 
responding to Congress. Congress needed to know which were the 
riskier problems that EPA was dealing with. And it should come 
from a central organizational structure with lots of external 
reviews.
    Chairwoman Sherrill. Thank you very much. And from our 
previous panel we learned that EPA's Office of Children Health 
Protection, or OCHP, believes formaldehyde is one of the top 
three or four IRIS priority chemicals for its office. That 
means formaldehyde is one of the major chemical dangers facing 
children today. Unfortunately, OCHP did not submit its 
priorities until it was too late in the process for them to be 
included. But, Dr. Rusyn, can you describe some of the 
documented health impacts of formaldehyde particularly for 
children and why our children are especially vulnerable to 
formaldehyde exposure?
    Dr. Rusyn. Thank you. I speak on my recollection from the 
information contained in the draft IRIS formaldehyde assessment 
that the committee that I served on reviewed in 2010 and 2011. 
I do not work on formaldehyde, so I'm not expert by any stretch 
of imagination. But the draft assessment included evaluation of 
the literature and derivation of toxicity values for inhalation 
exposure, which was of greatest concern. And the concerns that 
already were pointed out today especially from the 
particleboard in FEMA trailers and others, are something that 
is definitely bringing this type of a route of exposure to 
concern and especially because children are also exposed and 
are also considered a vulnerable population. This is something 
that the agency needed to account for in how they derived 
toxicity values from some of the studies in adults. So 
respiratory irritation and exacerbation of asthma and other 
types of respiratory illnesses were some of the health effects 
that were pointed out in the draft assessment.
    Chairwoman Sherrill. Thank you very much. And, Dr. Rusyn, 
since your participation in the 2011 National Academies' review 
of the draft formaldehyde assessment, what progress have you 
observed in IRIS' ability to implement the recommendations made 
and to increase its productivity and transparency?
    Dr. Rusyn. So, as I mentioned in my oral and written 
testimony, the process of IRIS evaluations is under a 
microscope and has been from all sides, from GAO, from 
Congress, from the National Academies, and from other 
stakeholders. The progress has been primarily focused on the 
process because the criticism that the 2011 report has provided 
was largely on the process and the transparency of the 
documents. So the systematic review process, the frequent 
releases of information that are now part of the IRIS Program's 
standard operating procedures increased transparency, increased 
the stakeholder engagement, and actually move the field 
forward. But it's important to note that risk assessment is not 
something that is stagnant. There's a lot of new data. There's 
a lot of methodological work, and I think IRIS is the leader in 
this pushing the methodology forward.
    Chairwoman Sherrill. And we have a few more seconds. How 
are they the leader would you say?
    Dr. Rusyn. The systematic review is something that is more 
established in the medical community where systematic reviews 
are undertaken to create centralized guidelines for certain 
conditions and for their treatments, so to standardize across 
different physicians and make sure that they're treating their 
patients based on best science. How to apply this process to 
environmental health was really unclear, so this is something 
that has only begun about 5 or 6 years. So IRIS Program has 
taken the leadership position in actually creating case studies 
and guidelines for this, so they're really pushing the field 
forward.
    Chairwoman Sherrill. Thank you. Thank you, everyone. And 
now the Chair will recognize Mr. Norman for 5 minutes.
    Mr. Norman. Thank you, Chairwoman Sherrill.
    Dr. Goodman, there's been a lot of talk about systematic 
review and higher standards to improve the IRIS Program. Can 
you explain the systematic review in layman's terms and 
describe why its implementation is critical to improving IRIS?
    Dr. Goodman. Yes, so the idea behind a systematic review is 
that there is a clearly formulated question and, based on that 
question, a protocol is developed for every aspect of the 
review, including the literature search strategy, what studies 
you're going to include and exclude, what information you're 
going to take from that--those studies, importantly, how you 
evaluate the quality of those studies, their strengths and 
limitations, and then how you integrate evidence from all these 
studies, especially when there's contradicting evidence, what 
you're going to do.
    And the reason why it's so critical is so that you truly 
get a sense of the whole state of the science. When a review is 
conducted that's not systematic, what ends up happening is 
critical information is ignored and then your conclusions 
aren't really based on a good solid scientific foundation.
    Mr. Norman. Thank you. And, again, Dr. Goodman, over the 
years, there's been a lot of uncertainty surrounding 
formaldehyde, specific criticisms of the IRIS Program's 
handling of the formaldehyde assessment. Last week, EPA 
announced that it will review formaldehyde in the TSCA program, 
which is an actual regulatory program that can set useful 
guidelines for the formaldehyde use. I think this is a 
tremendously positive step toward making meaningful 
determinations as to the risk associated with formaldehyde, and 
I applaud the Administration for taking this step. Can you--Dr. 
Goodman, again, can you please explain the potential downside 
of relying on an IRIS assessment of formaldehyde to dictate how 
we regulate that substance at the Federal level?
    Dr. Goodman. Well, I think, as it stands, the IRIS handbook 
hasn't been completed yet, so there's no standard operating 
procedure for conducting IRIS assessments. And so even though 
the assessments are moving in the direction of using systematic 
review, it hasn't--systematic review hasn't been fully 
implemented in any review to date, including what's been done 
on formaldehyde to date. So in that sense I think what's most 
important is that formaldehyde is reviewed in a systematic 
fashion.
    And I think the other aspect, as was talked about with the 
first panel, IRIS provides toxicity values and that--and these 
toxicity values take into account the hazard information, but 
they don't take the next step in saying what are uses, how are 
people using it, and what are the risks for those particular 
uses? And that is done under TSCA.
    Mr. Norman. OK. I'd like to thank each one of the witnesses 
for taking your time again. There's been a lot of controversy 
over IRIS, and we just want results. And thank you for taking 
the time. Chairwoman, I have no further questions.
    Chairwoman Sherrill. Thank you, Mr. Norman. I now recognize 
Ms. Bonamici for 5 minutes.
    Ms. Bonamici. Thank you so much to the Chairs and Ranking 
Members. Thank you to all of our witnesses for being here.
    I said during the first panel I've been on this Committee 
for more than 7 years, and I have sat through many hearings 
about IRIS and know that there--without question, there was a 
need to improve. But the direction that I'm seeing I do not 
consider improvement.
    Dr. Goldstein, in your testimony you discuss a development 
of the IRIS Program. I read your--back in the Ruckelshaus days 
and the importance of a centralized ORD-led approach to risk 
assessments and the value of independence of IRIS from other 
program offices. In a September 2017 letter, the EPA's Science 
Advisory Board reaffirmed that no other Federal entity performs 
IRIS functions and that IRIS helps ensure consistency in 
chemical assessment within the agency. I disagree with my 
colleagues who continue to call for the elimination of IRIS.
    And, Dr. Goldstein, based on your years of experience at 
the EPA, what are the consequences of diminishing the 
independence of IRIS? And how would consolidating the functions 
of IRIS into various program offices affect the quality of 
assessments?
    Dr. Goldstein. I think the quality of assessments would 
rapidly decline. It would be under the leadership of someone 
appointed as a political appointee to make sure that air is 
taken care of, water is taken care of, individual groups that 
have individual laws and they will respond by looking at ways 
that the risk be most supportive of what they think their 
policy approaches ought to be. We need an independent group 
that says what the science is and then everyone can use it but 
cannot play with it as much as would occur if you got rid of 
IRIS.
    Ms. Bonamici. Thank you. And, Dr. Goldstein, in your 
testimony you state that Administrator Wheeler's abrupt 
dismantling of extensive science-based independent review 
processes is unforgivable, and the current actions of EPA's 
leadership to be incredibly shortsighted at best. I'm very 
concerned about the lack of transparency, what appears to be a 
significant limitation on the number of chemicals that are 
being considered.
    I also appreciated the candid statement in your testimony 
that you would have resigned as Assistant Administrator of ORD 
if EPA leadership had tried to make the changes now being 
insisted on by Administrator Wheeler. I don't think we can 
brush this aside or ignore it. It's--I'm deeply concerned about 
the efforts to undermine scientific integrity and dismiss 
agency scientists and the EPA's work and the consequences that 
may endanger the EPA's ability to fulfill its mission. And we 
know that mission is protecting public health and the 
environment. What are the long-term consequences of the 
continued disrespect and dismissal of science at the EPA?
    Dr. Goldstein. Well, EPA will soon cease to function 
effectively. It will continue to have debate after debate after 
debate. The formaldehyde to me is a poster child of what 
happens when we let politics get in the way of making 
scientific--looking at the scientific basis for the 
decisionmaking. One can take the science and make a decision 
based upon what the laws are, what the policy issues are, but 
one should not discard the science and basically decide in 
advance I know what the science ought to be and then try to 
make policy on that. That policy will eventually fail.
    Ms. Bonamici. And thank you. And I have a question about 
the career staff. I know that there are still many career staff 
at the agency. How can we defend the work of the career staff 
when the EPA leadership is limiting the release of information 
to the public? What are your suggestions there?
    Dr. Goldstein. I think you've asked the most important 
question. My suggestion is as much oversight as you can give 
would be very, very welcome in this way. You know, hearings 
like this are just so important. And the career staff 
recognizes that.
    Ms. Bonamici. Thank you. And I want to reiterate what I 
mentioned in the hearing on the first panel that IRIS is an 
important program, yes. Based on the information we'd heard in 
the past and the recent GAO report, yes, there is room for 
improvement, and we can work together to bring about that 
improvement, but we absolutely must maintain the separation and 
respect the work of the career folks who are there trying to 
make sure that there is, science and transparency regarding 
IRIS and overall with the EPA.
    So thank you for your leadership, Chairwoman Fletcher and 
Chairwoman Sherrill and Ranking Members, and I yield back.
    Chairwoman Sherrill. Thank you very much.
    Now, the Chair recognizes Dr. Babin for 5 minutes.
    Mr. Babin. Thank you, Madam Chair. I appreciate it. And 
thank you, all you expert witnesses for being here as well.
    Dr. Goodman, do IRIS assessments integrate all lines of 
evidence, including potential adverse health effects to humans?
    Dr. Goodman. I think the goal of IRIS assessments is 
certainly to do that, and they do attempt to consider 
epidemiology, toxicology, mode of action, mechanistic evidence, 
but in practice sometimes relevant evidence is missed or in 
other times the evidence is all there but it's not evaluated in 
a systematic manner, meaning that, you know, not all studies 
are created equal. Some are more robust, they have more 
strengths. Others have more limitations. Just as an example, 
sometimes in epidemiology it's very difficult to estimate 
exposure, and some studies do a better job than others at 
coming up with good exposure measurements. So I think that can 
sometimes be an issue with IRIS assessments.
    Mr. Babin. OK. And then do IRIS assessments include any 
consideration of actual human exposures or make any 
determination of the actual human risk?
    Dr. Goodman. I believe that IRIS--the goal of the IRIS 
assessment is really to conduct a hazard assessment, and then 
once that assessment is done, it can then be used to evaluate 
risk----
    Mr. Babin. Oh.
    Dr. Goodman [continuing]. Based on human uses of chemicals 
and exposures.
    Mr. Babin. OK. Does the TSCA program consider human 
exposure?
    Dr. Goodman. Yes, it does.
    Mr. Babin. OK. And also is it true that other chemical 
assessment agencies like the World Health Organization 
recognize a safe threshold for formaldehyde exposure when they 
establish values for long-term exposure to formaldehyde?
    Dr. Goodman. Yes, I believe the World Health Organization 
has acknowledged that the key mechanism for formaldehyde in 
causing cancer is through cytotoxicity and cell proliferation, 
and that specific mechanism has a threshold. And what that 
means is there's an exposure level below which the body can 
actually handle exposures to formaldehyde, and this won't 
happen.
    Mr. Babin. OK. Well, then would you elaborate on--just a 
little bit on the importance of setting these safe threshold 
values?
    Dr. Goodman. Well, I think the idea is--the goal of all of 
these programs is to determine what safe levels are or what 
levels below which we can be confident that there isn't an 
increased risk for adverse effects on human health. And so we 
need that based on the best available science, and if the 
science suggests that a mechanism of cancer or any other health 
effect has a threshold, has a level below which there is no 
increased risk, that needs to be incorporated in an assessment.
    Mr. Babin. I see. And, Ms. Subra, you had mentioned--are 
you from Louisiana by the way? Are you from Louisiana? Did I 
hear you say you had some studies in Natchitoches and----
    Ms. Subra. Right.
    Mr. Babin [continuing]. Other areas? OK. Did you hear my 
last question? Would you like to elaborate on it as well?
    Ms. Subra. Could you repeat your question?
    Mr. Babin. Yes, OK. The importance of setting safe 
threshold values for anything----
    Ms. Subra. Right.
    Mr. Babin [continuing]. But we're talking about 
formaldehyde here, if you would elaborate on that as well 
because I know that you've had a lot of experience with this.
    Ms. Subra. Right. So based on the citizens' complaints we 
did air sampling and found that formaldehyde was the chemical 
present in the largest quantity in the ambient air around the 
facility where these people live, and then being able to 
coordinate that back to the resins that were used by the 
facility, that was the source of those emissions. And then we 
worked with the facility to get those resins replaced, and as a 
result, the formaldehyde in the air was non-detect once they 
changed the resin they were using. So the health impacts to the 
community improved tremendously based on removing that source 
of pollution.
    Mr. Babin. OK. Thank you. And I yield back, Madam Chair. 
Thank you very much.
    Chairwoman Sherrill. Well, thank you. And now the Chair 
recognizes Chairwoman Fletcher for 5 minutes.
    Mrs. Fletcher. Thank you, Madam Chair.
    The EPA program--program and regional offices routinely 
utilize IRIS assessments to meet the agency's mission. 
Similarly, as I mentioned earlier, State regulatory agencies 
are also highly dependent on IRIS values. I have with me a 
letter from the Colorado Department of Public Health and 
Environment (CDPHE), and I would like to add it to the record. 
So I'll ask that the letter be added to the record.
    Chairwoman Sherrill. Without objection.
    Mrs. Fletcher. And this letter from the CDPHE unequivocally 
states that they utilize IRIS toxicity values daily to protect 
Coloradans' health. Additionally, nongovernmental stakeholders 
utilize IRIS assessments to better educate and protect impacted 
communities.
    Ms. Subra, and your testimony describe how you utilize IRIS 
assessments in your work. How regularly do you reference the 
IRIS assessment values? Yes.
    Ms. Subra. Depending on what facility and community I'm 
working with and what all the chemicals are that are being 
released by that facility, if there are some that I want 
additional information on, I'll quickly check the IRIS database 
and see if it's available. So it may be once a week, it may be 
once a month, it may be once every 2 months, depending on what 
new issues I'm working on. But on issues I'm working on a 
regular basis I check it to see if anything new has been added 
to that website to enable the citizens to better understand 
what's going on.
    Mrs. Fletcher. And what is it specifically about the IRIS 
assessments that makes them a valuable resource to you as 
compared to other toxicity values?
    Ms. Subra. So early in the--my career you'd have to have 
access to TOXNET and things like that, and only medical schools 
had access and they didn't share that access, whereas when you 
look at IRIS, they have all the literature available, and you 
can then, if you are interested in any particular one, get 
access to it. So it pulls together all of the available 
information and journal articles in one place. I don't have to 
go to three, four, five, or six places. And they've done the 
compiling for me so I can quickly have access to that, and it 
saves time as I'm trying to work and educate and empower the 
communities.
    Mrs. Fletcher. And on a related note in connection with 
your work, what impacts to your work do you anticipate if the 
IRIS Program is stifled in its ability to be able to produce 
timely and comprehensive assessments?
    Ms. Subra. So I only respond to communities that request 
assistance, and then I look to see what those chemicals are. 
One of the things we found is when IRIS does the assessment and 
does come out with it, then it takes a long time to get it 
implemented and get the results of their assessment to reduce 
the exposure going on in the communities by working with the 
industrial facilities that are sources of that emission.
    Mrs. Fletcher. And how will impacted communities be 
affected by a delayed IRIS process?
    Ms. Subra. They are affected because of primarily the air 
emissions. In a lot of other cases it's water, groundwater, and 
solid waste. But when they're affected by the air, then we need 
a handle to be able to say this is what's going on in the 
ambient air in the community around this facility or these 
facilities, and then, because of the IRIS information, then we 
can determine whether or not it's harmful to the community and 
what impacts it has on their health and then work with both the 
industry, the local, the State, and the national, 
environmental, and health agencies to get those emissions in 
the ambient air reduced and thus reduce their exposure.
    Mrs. Fletcher. Thank you. And I just have a limited amount 
of time left, so I'll put this question out to everyone on the 
panel, all the witnesses. Do you believe or why do you believe 
the value of IRIS assessments for external stakeholders has 
improved and increased over time? If anybody wants to take that 
question.
    Dr. Goldstein. Lots of hard work and lots of oversight and 
insistence that that information be available.
    Dr. Rusyn. And I think as well the level of scrutiny that 
this program has and the level of scrutiny that each draft 
assessment undergoes really provides the best available science 
for that particular protective value in the cancer hazard 
classification.
    Mrs. Fletcher. Thank you. And I see I've gone over my time, 
so, Chairwoman Sherrill, I will yield back.
    Chairwoman Sherrill. Thank you. The Chair now recognizes 
Ranking Member Marshall.
    Mr. Marshall. Thank you so much, Chairwoman. I'll start 
with Dr. Goodman.
    I'm trying to understand linear assessments. When, as a 
physician, we give a patient medicine, we start off with the 
lowest dose possible, and then usually you'll hit a certain 
dose to finally get the response you're wanting. And I never 
see a linear progression to the side effects. It looks like we 
just steadily go up and then suddenly, there's a number that 
causes side effects. And I would think, you know, trying to 
apply toxicology might be the same in reverse. So do you 
typically use some type of linear analysis or is there 
typically drop-off points?
    Dr. Goodman. So right now, cancer is evaluated differently 
than noncancer effects, so for noncancer health effects, it's 
exactly as you say. When assessments are done, it's assumed 
that a minimum exposure is necessary to see any type of toxic 
effects, and below that exposure, those effects won't occur.
    Now, it's actually--it's based on a regulatory context, not 
based on biology, this idea that if there's something that can 
cause cancer, one molecule of that something can cause cancer. 
And so they do this process called linear low-dose 
extrapolation meaning obviously you can't do a scientific study 
of one molecule, so you take the higher doses and basically 
plot out on a curve what the association is between the dose of 
the chemical or exposure of the chemical and cancer risk, and 
then you extrapolate from that lowest dose down to zero, 
essentially assuming that there's risk down to zero. But if--
biologically that's not necessarily the case, particularly for 
certain carcinogens that have certain mechanisms. And in that 
case you should do exactly as you said. You should find the 
exposure level--the minimum exposure level where you can 
increase cancer risks, and then below that there's no evidence 
for an increased cancer risk.
    Mr. Marshall. How do you take the IRIS assessment cancer 
classifications and then apply them to actual human health 
risk? How do companies do that? The IRIS assessment cancer 
classifications and then I'm trying to relate that from taking 
that data to human risk.
    Dr. Goodman. Well, I think the idea--I mean, if you're 
talking about cancer, so a cancer slope factor, a number is 
calculated, that's an estimate of what--you know, what cancer 
risk is associated with specific exposures. But, as I said, 
there's this extrapolation down to low exposure levels because 
that can't be studied and so, by design, it is overestimating 
cancer risk.
    Mr. Marshall. Do private companies feel like IRIS has been 
transparent?
    Dr. Goodman. I don't know that I can speak for private 
companies, so I don't know that I should answer that. I think 
in some cases I would say I've heard----
    Mr. Marshall. Does industry feel like IRIS has been 
transparent?
    Dr. Goodman. Again, I don't know that I should speak for 
the industry, but I think there are some cases where the 
scientific judgments have not been clear in IRIS assessments.
    Mr. Marshall. OK. If you were in charge of IRIS, what 
solutions would make it better? What are your thoughts to 
improve IRIS?
    Dr. Goodman. First priority is complete that handbook 
because then we have a standard operating procedure so that all 
assessments are done in the same manner. Also make sure that 
all protocols and then actually the executed assessments are 
completely transparent so it's absolutely clear when decisions 
were made and the basis for those decisions.
    Mr. Marshall. Why has it taken so long to do it? Any idea? 
I'm kind of new to the game here. What have they told you why 
they haven't gotten it done before?
    Dr. Goodman. I don't think I'm the right person to answer 
that.
    Mr. Marshall. OK. All right. Think here for a second. Mr. 
Goldstein, what do you think--I mean, certainly, there's been a 
handbook that they'd used for decades I would assume. They have 
to have one. You could not supervise a lab without a handbook. 
What's taken so long to get this to Congress and to all of us?
    Dr. Goldstein. Sir, may I first answer the question you 
asked before? I'm a physician, and you used the issue of 
toxicity.
    Mr. Marshall. I guess I'd really--I got 38 seconds left, so 
I'd rather you answer this question.
    Dr. Goldstein. OK. I'll be--may I send that to you?
    Mr. Marshall. Sure.
    Dr. Goldstein. The answer to this question is simple, I 
just don't know. I'm not active at EPA right now. I do know 
that doing something like a handbook, unless Congress requires 
me to do it, in which case it becomes highest priority, is 
really not that easy on a moving subject like this. And as new 
science is brought in, as you heard about systems approaches, 
boy, by the time you get this finished----
    Mr. Marshall. I would say the first 20 steps are the same, 
though. The first 20 steps should be the same no matter which 
substance we're looking at, and I just can't believe it's been 
8 or 10 years.
    Thank you, and I yield back.
    Chairwoman Sherrill. Thank you.
    The Chair now recognizes Mr. Tonko for 5 minutes.
    Mr. Tonko. Thank you, Chairwoman Sherrill. And welcome to 
the panel. I firmly believe that we must ensure that 
inappropriate political interference in the scientific process 
does not get in the way of protecting our national security and 
public health. And, Dr. Goldstein, I know that you had an 
earlier exchange with my colleague, Representative Bonamici, 
and I wanted to delve a little further. But before I do that, 
why don't you express what you wanted to express if you could 
do that in a matter of seconds.
    Dr. Goldstein. OK. It's a very good question asked by Dr. 
Marshall. It had to do with toxicity. You see the toxicity very 
quickly, though, so if you're going to change the dose of a 
drug and see toxicity, that's an immediate response. Cancer is 
20, 30 years later. You won't see it as a physician. So it's 
not really pertinent to the way they do risk assessment, 
although it's a very good question.
    Mr. Tonko. OK. Thank you. And now back to political 
influence. In your testimony you touch upon how the current 
political manipulations in the IRIS Program reflect the general 
dysfunction at the EPA over the past 2 years, particularly with 
the CASAC (Clean Air Scientific Advisory Committee) particulate 
matter review. You go so far as to state that, and I quote, 
``There is no question that today we are at the lowest point 
ever since the formation of the EPA,'' close quote. This is 
alarming to hear from someone who has been a close observer of 
the agency for decades, particularly since you came to work at 
the EPA following the infamously dysfunctional and frequently 
hostile tenure of former Administrator Anne Gorsuch. How does 
this Administration follow the pattern of behavior exhibited by 
that Gorsuch EPA, and what makes this the lowest point in the 
agency's history?
    Dr. Goldstein. That's an easy question to answer. You 
mentioned the Clean Air Scientific Advisory Committee. Before 
becoming Assistant Administrator, I chaired that under Anne 
Gorsuch. Anne Gorsuch did not interfere with the actions of the 
Clean Air Scientific Advisory Committee. Administrator Wheeler 
is.
    Mr. Tonko. Well, what do you believe is the goal of these 
attempts to undermine science at the EPA wherever possible?
    Dr. Goldstein. Policymakers like to get the science they 
want rather than the science that exists. I mean, it's built 
into the tension of how we develop our regulations and how we 
protect the public.
    Mr. Tonko. So sheer manipulation. Dr. Goldstein, in your 
testimony you mentioned that when you found evidence that 
benzene is leukemogenic using funding from the American 
Petroleum Institute, your funding was cutoff. While you say you 
maintain respect for the scientific aptitude of industry, I 
must say this is troubling to hear. When you were working for 
industry, was there an understanding that your funding was 
dependent upon a particular outcome?
    Dr. Goldstein. They never said that they cut it off because 
of the outcome. They were short of money that year was the 
reason they gave. I think we all understood what the answer 
really was. But, no, the issue of working with industry I think 
it's really important. I think good scientists in academia 
should work with industry, but it must be done in a way that's 
very careful and must be understood exactly what industry 
wants.
    On the formaldehyde issue, I was asked to consult with 
industry right after the IARC (International Agency for 
Research on Cancer) meeting in 2010 said that it was a known 
leukemogen, and I told them they had to repeat the key study. 
They have yet to repeat it. Instead, they fund consultants to 
nitpick the study.
    Mr. Tonko. OK. Thank you. And given your experience, what 
is your impression of the insistence by the American Chemistry 
Council that the studies it funds exonerating formaldehyde are 
sufficient to upend or at least call into serious question the 
current weight of evidence regarding formaldehyde 
carcinogenicity--whatever--carcinogens----
    Dr. Goldstein. Cancer causation, sir.
    Mr. Tonko. Yes.
    Dr. Goldstein. These studies just indicate why this 
transparency idea is simply a ruse to be able to get raw data, 
not to be able to repeat the study but to be able to nitpick 
the study. Consultants get paid for nitpicking studies, 
changing blemishes into scars so that we will think there's a 
real problem. One of the studies is one that I responded to in 
print showing that their own data if anything proved the--
proved is too strong, but certainly strengthened the initial 
study, not discredited it.
    Mr. Tonko. Thank you very much. I just want to make a 
statement that scientific integrity is about, in my opinion, 
ensuring a process and atmosphere in which the science leads us 
to the results. Public science informs national policy on 
everything from pesticides to power grids. Our Nation's cities 
and States need credible information to prepare for climate 
change, and our families deserve to know if unsafe chemicals 
are being sprayed on their food, dumped into their water 
supplies, or added into the products they buy.
    The efforts to silence science, distort, and bury or delay 
the release of valuable science at EPA--and they serve as a 
reminder of the urgency of passing the Scientific Integrity 
Act, which I've introduced, to codify the requirement that all 
agencies have strong scientific integrity policies that ensure 
that science leads the way no matter the Administration. 
Anything short of that is simply unacceptable.
    And with that, Madam Chair, I will yield back.
    Chairwoman Sherrill. Thank you so much.
    I'd now like to recognize Mr. Cohen for 5 minutes.
    Mr. Cohen. Thank you, Madam Chair, and Merritt's mother.
    Dr. Goldstein, I am obviously not a toxicologist, not 
obviously but I'm not. But Mr. Marshall asked some questions 
earlier about ethylene oxide. He expressed concern that IRIS 
risk values for inhalation of ethylene oxide are 19,000 times 
lower than what the human body naturally produces. Do I have to 
go further? I see your kind of--you're ready to respond. Isn't 
it true that the human body produces and expels a lot of 
substances that it would be dangerous to consume or inhale? And 
is the presence of a chemical in some concentration--in the 
digestive system, for example--going to mean the same level of 
risk as if that chemical is found in your lungs? So can you 
tell us about comparing these different levels and various--
also the chemicals if they're in the soil versus the air versus 
the water we drink, et cetera, et cetera?
    Dr. Goldstein. Thank you for the question. The--what's 
fascinating to me is that industry has welcomed some recent 
research, which I think is pretty good research, that shows 
that about one-third of the--in my estimation, about one-third 
of all cancer is due to bad luck. Well, what--yes, I mean, it's 
going to happen whether we were exposed to anything or changed 
our environment. That's not true for all cancers, certainly 
lung cancer, others. But if you start with that as something 
that industry believes, well, that means it's something 
internal to our body. Well, if our body makes formaldehyde and 
ethylene oxide, those are likely causes of this if you live 
long enough you're going to get mutations to yourself that will 
cause cancer, which is what bad luck really is about.
    If you believe that, then clearly ethylene oxide can cause 
cancer and basically would be responsible for some bad luck. 
And if you think of it from the point of view of numbers, about 
25 percent of us will get cancer. If one-third is due to bad 
luck, that's about 8 percent of us. If we're talking about 
Congress telling us we have to regulate it, say, 1 in 100,000 
risk, well, 1 in 100,000, 8 percent of that is, what, 8,000 in 
100,000 is due to this bad luck. If you're telling us to 
regulate 1 in 1,000, a little bit more of ethylene oxide from 
the outside, a little bit more formaldehyde from the outside 
could easily produce that 1 in 8,000 that I just talked about, 
and that's the level that IRIS is supposed to be informing 
people about.
    So it--to me it doesn't--I just don't understand why 
ethylene oxide being an internal causation should make any 
difference to the IRIS approach.
    Mr. Cohen. Now you've got me totally confused.
    Dr. Goldstein. Sorry.
    Mr. Cohen. I took an aspirin religiously, taking it from 
right to left of course, for years, and then I read recently 
that for people that are--have the ability to remember Bill 
Mazeroski that this was a bad thing to do, that it was going to 
be hazardous to my health. Now you're telling me that cancer is 
caused by water. So is it--what----
    Dr. Goldstein. I didn't say that.
    Mr. Cohen. Well, I'm just thinking, is it kidney stones or 
is it cancer? Do I have to make a choice?
    Dr. Goldstein. No, please don't make that choice. But there 
is--I mean, none of us lives forever, and, as I said, there is 
reasonably good evidence that mutations occur spontaneously in 
the body for causes we don't understand but could well be 
ethylene oxide or formaldehyde or other carcinogens we make 
within our body, and that these represent--as I say, it's only 
one-third of cancer, so two-thirds are out there ready to be 
prevented. But if it's one-third, that's still, in relationship 
to the 1 in 100,000 risk, which isn't IRIS' choice. That's, if 
you will, your choice. That's the level of protection that the 
country wants. It's a very big number.
    Mr. Cohen. Let me ask you this. You worked at the EPA when 
President Reagan was in office, is that correct?
    Dr. Goldstein. Correct.
    Mr. Cohen. And Reagan was kind of known as a conservative 
and a guy that was pro-business. How would you compare 
Ruckelshaus and other EPA Administrators to Scott Pruitt?
    Dr. Goldstein. There's no comparison. I mean, it's--you're 
talking about a completely different approach. The respect for 
getting the science right from Bill Ruckelshaus, Lee Thomas, 
the two Administrators I worked under, was very strong. And, as 
I say, Anne Gorsuch did not interfere with the Clean Air 
Scientific Advisory Committee. I chaired it.
    Mr. Cohen. And then the Reagan Administration didn't try to 
interfere with EPA from giving information to the public to 
protect them as this Administration is?
    Dr. Goldstein. That's not--that wasn't my level of 
approach, so I can't really comment on that, but I do--on the 
other things, I certainly do feel there's a difference.
    Mr. Cohen. Thank you. And I yield back.
    Chairwoman Sherrill. Thank you very much.
    I now yield 5 minutes to Ms. Wexton.
    Ms. Wexton. Thank you, Madam Chair, and thank you to the 
witnesses for coming to testify before us this morning.
    Dr. Goodman, what kinds of organizations fund Gradient's 
research? Is it nonprofit organizations, trade organizations, 
corporations? What kind of groups fund your research?
    Dr. Goodman. We--it really runs the gamut from private to 
public and government and nonprofit and for-profit and trade 
groups.
    Ms. Wexton. OK. And some of the groups that you've done 
work for include the National Marine Manufacturers Association? 
Do remember doing some work for them?
    Dr. Goodman. I believe so, yes.
    Ms. Wexton. The Styrene Information and Resource Center?
    Dr. Goodman. Yes.
    Ms. Wexton. The Formaldehyde Council?
    Dr. Goodman. It--I don't remember, but it's possible.
    Ms. Wexton. OK. BPA Global Group?
    Dr. Goodman. Yes.
    Ms. Wexton. The American Petroleum Institute?
    Dr. Goodman. Yes.
    Ms. Wexton. ExxonMobil?
    Dr. Goodman. Yes.
    Ms. Wexton. The American Chemistry Council?
    Dr. Goodman. Yes.
    Ms. Wexton. OK. So are you--have you heard of this--the 
analysis by the Center for Public Integrity of 149 Gradient-
produced scientific articles and letters that found that 98 
percent of the time the research that was conducted by 
scientists at your company concludes that the chemical in 
question is harmless at levels to which people are typically 
exposed? Are you aware of that study?
    Dr. Goodman. I'm familiar with that article. I haven't 
looked at that statistic in a while, but if I remember 
correctly, it was quite misleading, and I'm happy to go back 
and look at it and provide you with something more----
    Ms. Wexton. So you don't agree that it was 98 percent?
    Dr. Goodman. No, I do not.
    Ms. Wexton. OK. So can you then give me an example of a 
time during your research at Gradient that you came to conclude 
that the exposure for--the exposure threshold for a particular 
chemical should actually be lower than an existing standard 
would suggest?
    Dr. Goodman. I don't know--I can't think of--not everything 
I do has to do with standards and whether the standard should 
be lower or higher, but I'm certainly--you know, the first 
thing that comes to mind was when I was doing an evaluation of 
a chemical in a toy and basically coming to the conclusion that 
there was a possible toxic effect for children playing with the 
toy, so that's just the one off the top of my head.
    Ms. Wexton. So was that a specific level that you came to 
conclude was--should be lower than what it was at the time?
    Dr. Goodman. Well, basically that the chemical shouldn't be 
in the toy at all because there was a not at risk.
    Ms. Wexton. OK. And in your research at Gradient, can you 
give me an example of a time that you came to a conclusion that 
a chemical you were hired to study is carcinogenic at typical 
exposure levels?
    Dr. Goodman. Again, I don't know--I--the types of things we 
do range from hazard assessment to risk assessment, so it's not 
always about, you know, common uses and what people are 
typically exposed to, but I'm actually--you know, this isn't 
cancer, but I--I'm thinking now I actually have in the 
published literature and actually some of this work was funded 
by the American Petroleum Institute, as you mentioned, and some 
by actually the Texas Commission on Environmental Quality, 
which is a government agency, where we looked at air pollutants 
and risks of asthma and some other respiratory effects, and we 
did find that there was an increased risk for certain effects. 
So--and again, I'm happy to give you a list of that if you----
    Ms. Wexton. And was that research that you specifically 
participated in at Gradient or just peer-reviewed articles and 
scholarly journals that you have read?
    Dr. Goodman. It was research we--I'm not exactly sure what 
the question is. It was some--we've done some original research 
where we actually look at air pollution data and health 
outcomes, and then we done systematic reviews like we're 
talking about here today where we looked at all the published 
studies and said what it came to together. And all of that work 
has been published in the peer-reviewed literature.
    Ms. Wexton. And have you ever worked on a study for 
Gradient where the client proposed their own conclusion, that 
is, what they were hoping that the data would show?
    Dr. Goodman. I--not that I can think of, but in the end, it 
doesn't matter. I mean, that's--we get hired to do independent 
scientific analyses and conduct them with rigor and 
transparency and adhere to the highest scientific principles.
    Ms. Wexton. And, Dr. Goldstein, in your testimony you 
indicated that you have some extensive knowledge or experience 
working with industry. And based on your knowledge of industry-
supported science, how frequently are results found that 
contradict the business interests of the company or trade group 
that's funding the research?
    Chairwoman Sherrill. And if you could answer quickly. The 
gentlewoman's time----
    Dr. Goldstein. I will say not that unusually internally. I 
mean, that's the role of internal scientists and industry is to 
keep them out of trouble by having them not do the wrong thing, 
so that's not uncommon. How much gets public is----
    Ms. Wexton. Is another story, right. Thank you very much. I 
yield back.
    Chairwoman Sherrill. Thank you. And now, I believe the 
Ranking Member, Mr. Norman, has a question he would like to 
add, so I yield 1 minute to him.
    Mr. Norman. Thank you, Chairwoman Sherrill.
    Just to kind of follow up with this conversation we've been 
having, I mean, Dr. Goodman, you're independent, and I think 
Dr. Goldstein was mentioning as independent contractors if you 
will you may cherry-pick different things to have a desired 
outcome. Of all the companies you've had, have you had anybody 
put pressure on you to come up with an outcome that may or may 
not be what they wanted?
    Dr. Goodman. The answer to that is no. Again, I get hired 
to do independent analyses. But I think this whole idea of 
systematic review and transparency, that's kind of the whole 
point. That is the work I do. I use a protocol, we do it 
systematically, and everything is transparent, so the idea is 
anyone can see the methods we use, the judgments that were 
made.
    Mr. Norman. And I'm in the private arena, and we hire a lot 
of consultants. For liability reasons alone, it would not make 
sense for us to put any pressure on any business. We want to be 
protected--as I think Dr. Goldstein mentioned, we want to be 
protected, and the easiest way to have--invite a lawsuit is to 
try to have a desired outcome, which is not the end result. The 
media portrays that, but it's--in real life, in the real world 
that's not how it works.
    Thank you so much. I yield back.
    Chairwoman Sherrill. Thank you to the Ranking Member.
    Before we bring this hearing to a close, I want to thank 
our witnesses for testifying before the Committee today. The 
record will remain open for 2 weeks for additional statements 
from the Members and for any additional questions the Committee 
may ask of the witnesses.
    The witnesses are excused, and the hearing is now 
adjourned. Thank you.
    [Whereupon, at 12:55 p.m., the Subcommittees were 
adjourned.]

                               Appendix I

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                              Appendix II

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                   Additional Material for the Record

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