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




 
                       STRENGTHENING TRANSPARENCY
                         OR SILENCING SCIENCE?
                THE FUTURE OF SCIENCE IN EPA RULEMAKING

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

                                HEARING

                               BEFORE THE

                      COMMITTEE ON SCIENCE, SPACE,
                             AND TECHNOLOGY
                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED SIXTEENTH CONGRESS

                             FIRST SESSION

                               __________

                           NOVEMBER 13, 2019

                               __________

                           Serial No. 116-53

                               __________

 Printed for the use of the Committee on Science, Space, and Technology
 
 
 
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT] 
 


       Available via the World Wide Web: http://science.house.gov
       
       
       
       
       
                          ______                      


             U.S. GOVERNMENT PUBLISHING OFFICE 
 38-271 PDF          WASHINGTON : 2020       
       
       
       

              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                RALPH NORMAN, South Carolina
MIKIE SHERRILL, New Jersey           MICHAEL CLOUD, Texas
BRAD SHERMAN, California             TROY BALDERSON, Ohio
STEVE COHEN, Tennessee               PETE OLSON, Texas
JERRY McNERNEY, California           ANTHONY GONZALEZ, Ohio
ED PERLMUTTER, Colorado              MICHAEL WALTZ, Florida
PAUL TONKO, New York                 JIM BAIRD, Indiana
BILL FOSTER, Illinois                JAIME HERRERA BEUTLER, Washington
DON BEYER, Virginia                  FRANCIS ROONEY, Florida
CHARLIE CRIST, Florida               GREGORY F. MURPHY, North Carolina
SEAN CASTEN, Illinois
BEN McADAMS, Utah
JENNIFER WEXTON, Virginia
VACANCY

                         C  O  N  T  E  N  T  S

                           November 13, 2019

                                                                   Page

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

                           Opening Statements

Statement by Representative Eddie Bernice Johnson, Chairwoman, 
  Committee on Science, Space, and Technology, U.S. House of 
  Representatives................................................     9
    Written statement............................................    10

Statement by Representative Frank Lucas, Ranking Member, 
  Committee on Science, Space, and Technology, U.S. House of 
  Representatives................................................    10
    Written statement............................................    12

                               Witnesses:

Panel 1:

Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant 
  Administrator for Science, EPA Office of Research and 
  Development (ORD); EPA Science Advisor
    Oral Statement...............................................    13
    Written Statement............................................    16

Discussion.......................................................    22

Panel 2:

Dr. Linda S. Birnbaum, Scientist Emeritus, National Institute of 
  Environmental Health Sciences (NIEHS); Director of NIEHS, 2009-
  2019
    Oral Statement...............................................    47
    Written Statement............................................    49

Dr. Mary B. Rice, Assistant Professor of Medicine, Harvard 
  Medical School; Pulmonary and Critical Care Physician, Beth 
  Israel Deaconess Medical Center
    Oral Statement...............................................    54
    Written Statement............................................    56

Dr. David Allison, Dean, School of Public Health, Indiana 
  University-Bloomington; Member, ``Reproducibility and 
  Replicability in Science'' Committee, the National Academies of 
  Sciences, Engineering and Medicine
    Oral Statement...............................................    63
    Written Statement............................................    65

Dr. Brian Nosek, Co-Founder and Executive Director, Center for 
  Open Science
    Oral Statement...............................................    79
    Written Statement............................................    81

Dr. Todd Sherer, CEO, the Michael J. Fox Foundation for 
  Parkinson's Research
    Oral Statement...............................................    86
    Written Statement............................................    88

Discussion.......................................................    96

             Appendix I: Answers to Post-Hearing Questions

Dr. Jennifer Orme-Zavaleta, Principal Deputy Assistant 
  Administrator for Science, EPA Office of Research and 
  Development (ORD); EPA Science Advisor.........................   108

Dr. Mary B. Rice, Assistant Professor of Medicine, Harvard 
  Medical School; Pulmonary and Critical Care Physician, Beth 
  Israel Deaconess Medical Center................................   109

Dr. Todd Sherer, CEO, the Michael J. Fox Foundation for 
  Parkinson's Research...........................................   110

            Appendix II: Additional Material for the Record

Letter submitted by Representative Eddie Bernice Johnson, 
  Chairwoman, Committee on Science, Space, and Technology, U.S. 
  House of Representatives.......................................   114

Article submitted by Representative Suzanne Bonamici, Committee 
  on Science, Space, and Technology, U.S. House of 
  Representatives................................................   116

News release submitted by Representatives Suzanne Bonamici and 
  Brian Babin, Committee on Science, Space, and Technology, U.S. 
  House of Representatives.......................................   118

Letters submitted by Representative Lizzie Fletcher, Committee on 
  Science, Space, and Technology, U.S. House of Representatives..   121

Letter submitted by Representative Haley Stevens, Committee on 
  Science, Space, and Technology, U.S. House of Representatives..   128

Letter submitted by Representative Paul Tonko, Committee on 
  Science, Space, and Technology, U.S. House of Representatives..   130

Memorandum submitted by Representative Sean Casten, Committee on 
  Science, Space, and Technology, U.S. House of Representatives..   132

Documents submitted by Representative Dr. Mary Rice, Assistant 
  Professor of Medicine, Harvard Medical School; Pulmonary and 
  Critical Care Physician, Beth Israel Deaconess Medical Center..   138


                       STRENGTHENING TRANSPARENCY

                         OR SILENCING SCIENCE?

                         THE FUTURE OF SCIENCE

                           IN EPA RULEMAKING

                              ----------                              


                      WEDNESDAY, NOVEMBER 13, 2019

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

    The Committee met, pursuant to notice, at 10:02 a.m., in 
room 2318 of the Rayburn House Office Building, Hon. Eddie 
Bernice Johnson [Chairwoman of the Committee] presiding.

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]

    Chairwoman Johnson. The hearing will come to order. And 
without objection, the Chair is authorized to declare a recess 
at any time.
    Good morning, and let me welcome our witnesses today, 
``Strengthening Transparency or Silencing Science? The Future 
of Science in EPA Rulemaking.'' We're here today to discuss a 
proposed rule that EPA (Environmental Protection Agency) 
released last year, entitled, ``Strengthening Transparency in 
Regulatory Science.''
    This is not a new issue for this Committee. Between 2014 
and 2017, we saw three markups of legislation mirroring the so-
called transparency principles of the proposed rule. The Secret 
Science Reform Act, the HONEST Act, and now the ``Strengthening 
Transparency in Regulatory Science'' rule have all been met 
with the same passionate negative response from the scientific 
community. This rule makes dangerous, sweeping assertions about 
what does and does not count as good science.
    With the public availability of data as the determining 
factor, EPA will eliminate many fundamental public health 
studies from consideration, effectively gutting health-
protective regulations that keep our air and water clean.
    I am attaching to my statement a letter from over 60 public 
health groups, including the Michael J. Fox Foundation and the 
Center for Open Science, both represented on our second panel, 
where they express serious concerns about this proposed rule's 
impact on public health.
    No one in this room is against the principles of 
transparency in science or in our government. However, this 
rule warps the noble goal of transparency into a misleading, 
black-or-white test of the legitimacy of individual studies. 
I've said it many times in this very hearing room: The 
requirement for data to be publicly available is nothing more 
than an attempt to undercut EPA's mandate to use the best 
available science. I believe this is part of an effort to 
destroy regulations that protect public health but are opposed 
by some regulated industries.
    The public comment period for this rule was remarkable. 
Around 600,000 comments were filed, the vast majority of which 
were highly critical. Commenters panned the harmful 
consequences of the rule for public health and the dubious 
legal justification for the rule. Because EPA neglected to 
offer definitions for some of the fundamental terms it 
describes, terms like ``reproducible'' and even ``data,'' many 
comments wondered what parts of the rule even mean.
    In his September appearance before this Committee, 
Administrator Wheeler announced that a supplementary rule would 
be issued in early 2020. I think today's hearing is critically 
important to the Committee Members, as well as our 
distinguished second panel of scientists that will express our 
concerns before the rule is finalized. I am very worried that 
EPA is ignoring its mission to protect human health and the 
environment in an effort to make it easier for regulated 
industry.
    However, I am hopeful that the Agency takes to heart what 
our esteemed panel of scientists has to say about the rule as 
it works to finalize a supplemental proposal. Thank you.
    [The prepared statement of Chairwoman Johnson follows:]

    Good morning. I would like to welcome our witnesses to 
today's hearing -- ``Strengthening Transparency or Silencing 
Science? The Future of Science in EPA Rulemaking.''
    We are here today to discuss a proposed rule that EPA 
released last year, entitled ``Strengthening Transparency in 
Regulatory Science.'' This is not a new issue for this 
Committee. Between 2014 through 2017, we saw three markups of 
legislation mirroring the so-called ``transparency'' principles 
of the proposed rule. The Secret Science Reform Acts, the 
HONEST Act, and now the ``Strengthening Transparency in 
Regulatory Science'' rule have all been met with the same 
passionate negative response from the scientific community.
    This rule makes dangerous, sweeping assertions about what 
does and does not count as good science. With the public 
availability of data as the determining factor, EPA will 
eliminate many foundational public health studies from 
consideration, effectively gutting health-protective 
regulations that keep our air and water clean. I am attaching 
to my statement a letter from over 60 public health groups - 
including the Michael J. Fox Foundation and the Center for Open 
Science, both represented on our second panel - where they 
express serious concerns about this proposed rule's impact on 
public health.
    No one in this room is against the principle of 
transparency in science or in our government. However, this 
rule warps the noble goal of transparency into a misleading, 
black-or-white test of the legitimacy of individual studies. 
I've said it many times in this very hearing room: The 
requirement for data to be publicly available is nothing more 
than an attempt to undercut EPA's mandate to use the best 
available science. I believe this is part of an effort to 
destroy regulations that protect public health but are opposed 
by some regulated industries.
    The public comment period for this rule was remarkable. 
Around 600,000 comments were filed, the vast majority of which 
were highly critical. Commenters panned the harmful 
consequences of the rule for public health and the dubious 
legal justification for the rule. Because EPA neglectedto offer 
definitions for some of the fundamental terms it describes - 
terms like ``reproducible'' and even ``data'' - many commenters 
wondered what parts of the rule even mean.
    In his September appearance before this Committee, 
Administrator Wheeler announced that a supplemental rule would 
be issued in early 2020. I think today's hearing is critically 
important so that Committee Members, as well as our 
distinguished second panel of scientists, can express our 
concerns before the rule is finalized.
    I am very worried that EPA is ignoring its mission to 
protect human health and the environment in an effort to make 
life easier for regulated industry. However, I am hopeful that 
the Agency takes to heart what our esteemed panel of scientists 
has to say about this rule as it works to finalize a 
supplemental proposal.Thank you.

    Chairwoman Johnson. I now would recognize our Ranking 
Member, Mr. Lucas, for an opening statement.
    Mr. Lucas. Thank you, Madam Chairwoman, and thank you to 
our witnesses for being here today.
    Transparency and reproducibility are an important part of 
ensuring the quality of the science that supports Federal 
regulations. By providing access to research data, scientists 
can replicate previous results to assure validity, relevance, 
and accuracy. We all want Federal agencies to rely on the best 
available science when making policy. I believe that we need a 
broader conversation on the best way for the Federal Government 
to conduct and to use transparent science that can be 
independently verified.
    Unfortunately, this hearing is narrowly focused on one 
proposed rule from one agency. This is about attacking the EPA 
under the current Administration, not about improving 
transparency and scientific integrity. I believe this is a 
missed opportunity to have a more holistic, productive 
discussion on an important topic.
    Ensuring that government research is transparent and can be 
independently verified is not a new goal. The Obama 
Administration issued memos on the need to promote public 
access to scientific information and include the underlying 
data for policy decisions. So in 2018, the EPA issued 
``Strengthening Transparency in Regulatory Science,'' a rule 
that would prioritize those efforts.
    I think this is a laudable goal. After all, if taxpayers 
are expected to follow costly regulations, they should be able 
to trust that they stem from the best available science that 
can be independently verified. If Federal agencies are relying 
on data that can't be used for future research, it's impossible 
to know if the initial results were obtained by accurate 
science or simply by chance.
    I believe the EPA's proposed rule is well-intended, but 
there's still work to be done. That's why I was pleased to hear 
Administrator Wheeler confirm that the Agency is currently 
working on a supplemental rule for this topic. And while 
today's hearing will focus on the proposed rule, which was 
issued by the previous EPA administrator, we already know this 
won't be the final proposal from the Agency. So why are we 
holding a hearing on the original proposed rule that will be 
irrelevant in just a month or so?
    What's worse, Dr. Jennifer Orme-Zavaleta, and from now on, 
Doc, I'll refer to you as ``Dr.'' if you don't mind, who joins 
us from the EPA today, will be unable to comment on the 
development of the proposed rule, as she did not serve in the 
relevant office at the time it was issued. And because the 
supplemental rule is currently in the drafting process, the 
Doctor is also unable to comment on its specific requirements 
or details. It is my understanding that, once it's released, 
the supplemental rule will receive its own comment period and 
then move through the regular implementation process.
    I can't help but think this hearing would be more 
productive if we had waited for the supplemental rule to be 
published and then provided our comments and direction on the 
most current proposal.
    In closing, I'd like to emphasize that I think we could 
have a much more productive hearing if we had a broader 
discussion about the best way to improve reproducibility and 
transparency. I also want to say that if we can't improve the 
transparency of underlying data, then Congress should do our 
job and authorize the funding necessary to update and replicate 
vital research in a more transparent manner.
    I'm hopeful that our second panel today can address the 
broader issues of transparency in science. I'm particularly 
interested in the testimony from Dr. David Allison on behalf of 
the National Academies of Science, who currently completed a 
study on reproducibility initiated by the Committee.
    I'm also pleased to welcome Dr. Brian Nosek, who joins us 
from the Center for Open Science, and is currently exploring 
ways to facilitate and encourage transparency in the research 
community from the ground up. I look forward to hearing about 
constructive ideas on how policymakers and agencies can balance 
the reproducibility and the need to protect individual privacy 
and maintain data security.
    I thank our witnesses for taking the time to appear before 
us. I hope we can have an open and productive conversation on 
the broad issue of transparency in science.
    With that, I yield back, Madam Chair.
    [The prepared statement of Mr. Lucas follows:]

    Thank you, Madam Chairwoman, and thank you to our witnesses 
for being here today.
    Transparency and reproducibility are an important part of 
ensuring the quality of the science that supports federal 
regulations. By providing access to research data, scientists 
can replicate previous results to assure validity, relevance, 
and accuracy.
    We all want federal agencies to rely on the best available 
science when making policy. And I believe that we need a 
broader conversation on the best way for the federal government 
to conduct and use transparent science that can be 
independently validated.
    Unfortunately, this hearing is narrowly focused on one 
proposed rule from one agency.
    This is about attacking the EPA under the current 
administration-not about improving transparency and scientific 
integrity. I believe this is a missed opportunity to have a 
more holistic, productive discussion on an important topic.
    Ensuring that government research is transparent and can be 
independently verified is not a new goal. The Obama 
Administration issued memos on the need to promote public 
access to scientific information and include the underlying 
data for policy decisions.
    So in 2018, the EPA issued ``Strengthening Transparency in 
Regulatory Science,'' a rule that would prioritize these 
efforts.
    I think this is a laudable goal. After all, if taxpayers 
are expected to follow costly regulations, they should be able 
to trust that they stem from the best available science that 
can be independently verified.
    If federal agencies are relying on data that can't be used 
for future research, it's impossible to know if the initial 
results were obtained by accurate science or simply by chance.
    I believe the EPA's proposed rule is well-intentioned, but 
there is still work to be done. That's why I was pleased to 
hear Administrator Wheeler confirm that the agency is currently 
working on a supplemental rule for this topic.
    And while today's hearing will focus on the proposed rule, 
which was issued by the previous EPA Administrator, we already 
know this won't be the final proposal from the agency.
    So why are we holding a hearing on the original proposed 
rule that will be irrelevant in just a month or so?
    What's worse, Dr. Jennifer Orme-Zavaleta, who joins us from 
the EPA today, will be unable to comment on the development of 
the proposed rule, as she did not serve in the relevant office 
at the time it was issued. And because the supplemental rule is 
currently in the drafting process, Dr. Orme-Zavaleta is also 
unable to comment on its specific requirements, or details.
    It is my understanding that once it's released, the 
supplemental rule will receive its own comment period, and then 
move through the regular implementation process.
    I can't help but think this hearing would be more 
productive if we had waited for the supplemental rule to be 
published, and then provided our comments and direction on the 
most current proposal.
    In closing, I'd like to again emphasize that I think we 
could have a much more productive hearing if we had a broader 
discussion about the best way to improve reproducibility and 
transparency.
    I also want to say that if we can't improve the 
transparency of underlying data, then Congress should do our 
job and authorize the funding necessary to update and replicate 
vital research in a more transparent manner.
    I'm hopeful that our second panel today can address the 
broader issue of transparency in science. I am particularly 
interested in testimony from Dr. David Allison on behalf of the 
National Academies of Science, who recently completed a study 
on reproducibility initiated by this Committee.
    I'm also pleased to welcome Dr. Brian Nosek, who joins us 
from the Center for Open Science, and is currently exploring 
ways to facilitate and encourage transparency in the research 
community from the ground up.
    I look forward to hearing about constructive ideas on how 
policymakers and agencies can balance reproducibility with the 
need to protect individual privacy and maintain data security.
    I thank our witnesses for taking the time to appear before 
us today and I hope we can have an open and productive 
conversation on the broad issue of transparency in science. I 
yield back, Madam Chair.

    Chairwoman Johnson. Thank you, Mr. Lucas.
    If there are Members who wish to submit additional opening 
statements, your statements will be added to the record at this 
point.
    And at this time I'd like to introduce the witness for our 
first panel. Dr. Jennifer Orme-Zavaleta is the Principal Deputy 
Assistant Administrator for Science with the Office of Research 
and Development (ORD) and the Science Advisor for the 
Environmental Protection Agency. This is her second time 
testifying before this Committee during the 116th Congress. I 
welcome you back and thank you for your time.
    You will have 5 minutes for your spoken testimony. Your 
written testimony will be included in the record for the 
hearing. And when you have completed your spoken testimony, we 
will begin with questions. Each Member will have 5 minutes for 
questions.
    You now may proceed, and thank you for being here.

            TESTIMONY OF DR. JENNIFER ORME-ZAVALETA,

            PRINCIPAL DEPUTY ASSISTANT ADMINISTRATOR

                FOR SCIENCE, OFFICE OF RESEARCH

             AND DEVELOPMENT, AND SCIENCE ADVISOR,

                ENVIRONMENTAL PROTECTION AGENCY

    Dr. Orme-Zavaleta. Good morning, and thank you.
    Madam Chairwoman Johnson and Ranking Member Lucas, as 
noted, my name is Jennifer Orme-Zavaleta, please call me 
Jennifer. I'm the Principal Deputy Assistant Administrator for 
Science in the U.S. Environmental Protection Agency's Office of 
Research and Development, and 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 at EPA since 1981, and of the 
38 years I've been with EPA, I've spent 25 years in ORD.
    I appreciate the opportunity to talk with you today about 
EPA's proposed rule to strengthen transparency in regulatory 
science.
    EPA is committed to transparency and giving public access 
to its data and research, and we have made great strides on 
this. EPA's efforts span administrations, from 2013 OSTP 
(Office of Science and Technology Policy) memo to increase 
access to federally funded research, to the Evidence-Based 
Policymaking Act of 2018 and to OMB's (Office of Management and 
Budget's) 2019 memo on improving the Information Quality Act. 
For example, EPA's plan to increase access to results of EPA-
funded scientific research was finalized in 2016. Since then, 
EPA has implemented all three phases outlined in the plan. This 
includes working to ensure EPA's own research publications and 
the underlying data for these publications are publicly 
accessible, as well as working to increase access to EPA-funded 
research. These efforts are more outlined on some of our 
websites.
    In addition to these efforts, EPA initiated a rulemaking 
process in 2018 to increase transparency and public access to 
scientific data. EPA's proposed rule, `Strengthening 
Transparency in Regulatory Science,' seeks to ensure that the 
science underlying EPA's actions is publicly available in a 
manner sufficient for independent validation.
    The proposed rule would require that data and models 
underlying studies to support significant EPA regulatory 
actions, regardless of who generated or funded them, be made 
publicly available. EPA intends to release a supplemental 
proposed rule for public comment in early 2020 to provide 
clarifications on certain terms and aspects of the proposed 
rule.
    While EPA believes that maximizing transparency is 
important, the Agency understands that there may be instances 
in which data and models cannot be made available. Thus, the 
proposed rule states that the EPA Administrator may grant an 
exception if it is not practicable to ensure that data and 
models are publicly available.
    EPA issued the proposed rule on April 30, 2018 and held a 
public hearing that summer, in which some of you participated, 
and provided comment. The public comment period was extended 
after request from the public and from Congress, and it closed 
on August 16, 2018. During that time, we received nearly 
600,000 comments. More than 9,200 of these were unique 
comments, many of which raised very complex issues.
    Comments were submitted by professional organizations, 
States, tribes, industry, environmental groups, health groups, 
universities, the general public, and more. Almost all 
commenters supported the goal of greater transparency even if 
they disagreed with the approach in the proposed rule. And 
these comments covered many complex topics, and EPA is 
currently working hard to address these issues.
    EPA also solicited feedback from the Science Advisory Board 
(SAB) on personally identifiable information or PII and 
confidential business information, CBI. EPA received these 
comments in September, and the comments are publicly available 
and are being considered as we develop the final rule. The SAB 
is also providing comments on the entire rule, and we 
anticipate receiving those comments soon.
    EPA has just sent a supplemental rule to OMB for 
interagency review. The supplemental rule was developed because 
we received so many public comments, and we wanted to provide 
clarifications on certain terms and aspects of that proposed 
rule. We are committed to ensuring adequate time for public 
review of the supplemental rule, and we anticipate releasing it 
for public comment in early 2020.
    Since the supplemental rule is not yet public and is still 
undergoing review, I cannot speak to particular details, but 
once we get further in the process, I'd be happy to offer 
briefings on the supplemental rule.
    As you know, an older draft version of the supplemental 
rule leaked to The New York Times, and I would like to clarify 
a few things. First, the version that was published in The New 
York Times was an outdated version and is not what was sent to 
OMB for interagency review. Second, the supplemental rule is a 
supplement to the proposed rule. It is not a new rule or a new 
draft of the proposed rule. Rather, it's a supplement that 
contains clarifications, modifications, and additions to 
certain provisions in the proposed rule.
    And last, the proposed rule applies prospectively to 
regulations. It does not apply to already-established rules and 
regulations. The proposed rule does apply to dose-response data 
and models that inform significant rules made in the future, 
including data and models that were previously developed. The 
supplemental rule will be available for public comment, as I 
noted, in early 2020, and we anticipate finalizing the proposed 
rule next year.
    So EPA is committed to greater transparency, protecting PII 
and CBI, following all applicable laws and regulations, and 
continuing to protect public health and the environment. Thank 
you again for the opportunity to appear before you today, and 
I'm happy to answer any questions.
[The prepared statement of Dr. Orme-Zavaleta follows:]
    
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
           
    Chairwoman Johnson. Thank you very much. We will now begin 
our questioning period. And I will yield to myself 5 minutes.
    Doctor, the EPA cannot carry out its mission to protect 
public health and the environment without considering the best 
available science. Congress requires that the Agency's 
decisions be informed by the latest, most accurate scientific 
data. By preventing EPA from considering critical scientific 
studies, the proposed rule would exclude the best available 
science and endanger the public. Does the Agency consider it 
reasonable or wise to categorically eliminate studies, for 
example, all human epidemiology studies based on that one 
factor?
    Dr. Orme-Zavaleta. So the Agency is committed to using the 
best available science in its decisions while also providing 
greater transparency to help the public understand how those 
science informations were used in reaching those decisions. 
This is a point that we received a number of comments on and 
also what's contributing to the supplemental rule because we 
need to seek further information before we make decisions on 
that final rule.
    Chairwoman Johnson. Now, tell me then, how can EPA meet the 
statutory obligations to use the best available science in laws 
such as the Safe Drinking Water Act and the Toxic Substances 
Control Act if the rule would prevent it from considering 
certain studies even if they are considered definitive by the 
research community?
    Dr. Orme-Zavaleta. So the issue of science and public 
trust, there's a couple of aspects to keep in mind. When 
looking at good science, there are other tenets that weigh 
heavily in looking at how well studies were conducted, their 
quality assurance, what type of external peer review they went 
through, and overarching scientific integrity. And that's what 
contributes to good science.
    The idea with the transparency rule is to provide the data 
available to the public so they understand how that science was 
used in making decisions.
    Chairwoman Johnson. The rule has a provision wherein the 
Administrator can unilaterally exempt a study from the rule. 
Would EPA scientists, including yourself, consider it 
appropriate for a political appointee to have this arbitrary 
power over EPA's science?
    Dr. Orme-Zavaleta. So this is also a topic that we received 
a number of comments on from a variety of different sectors, 
and that's something that we're weighing very heavily as we 
look through in developing the final rule.
    Chairwoman Johnson. OK. In your nearly 40 years at EPA, can 
you personally recall any instance in which considering less 
science led to a better policy decision by the Agency?
    Dr. Orme-Zavaleta. So my time at EPA has been in a variety 
of different facets, some involving some rulemaking, but, 
again--so I can't speak to that specifically from my own 
experience. But we are working hard to ensure that the Agency 
is evaluating the best available science while meeting all of 
the other requirements for providing the public information so 
that they can understand how we made the decisions that we 
made.
    Chairwoman Johnson. Thank you very much. I'll now recognize 
Mr. Lucas.
    Mr. Lucas. Thank you, Madam Chair.
    Jennifer, and you said I could call you Jennifer----
    Dr. Orme-Zavaleta. Indeed.
    Mr. Lucas [continuing]. You addressed it in your testimony, 
and I think all of us read some of the news media, so it's no 
secret that a version of the supplemental rule was leaked and 
reported by The New York Times. And, by the way, for the record 
I happen to have a copy of the document that was used in that 
story. And just for note again to repeat one more time, is this 
the most recent version of the supplemental rule?
    Dr. Orme-Zavaleta. That is not the most current version. 
That is an older version, and that was not what was submitted 
to OMB last Friday.
    Mr. Lucas. Thank you. Now, I ask, because, as I said in my 
opening statement, it seems like this hearing is premature and 
that it would be more productive if we waited for the 
supplemental rule to be published, not leaked, and provide our 
comments and direction on the most current proposal. Can you 
confirm that the supplemental rule is still in the drafting 
process?
    Dr. Orme-Zavaleta. So the supplemental rule was submitted 
to OMB, and it's now part of the interagency review process. We 
will see what comments come back from that review. We'll work 
to finalize the supplemental rule and then issue it for public 
comment early next year.
    Mr. Lucas. Do you agree that a productive hearing would 
result from conversations based on a published rule, not a 
leaked version?
    Dr. Orme-Zavaleta. So we are happy to be here today to 
answer questions that you may have. What input we receive today 
we will add into all the other comments that we have for 
consideration. We're happy to provide further briefings as more 
information becomes available.
    Mr. Lucas. In The New York Times article the reporter 
stated, ``The new version does not appear to have taken any of 
the opposition into consideration.'' It's my understanding that 
once it's released the supplemental rule will also be open for 
public comment and then move through the regular implementation 
process. Is that correct and consistent with the rulemaking 
process?
    Dr. Orme-Zavaleta. That's part of the rulemaking process. 
And I would note that the reason that we have a supplemental 
rule is actually because of the number of comments that were 
raised and some of the complex issues and the need for 
clarification. And so it's because of that input we felt it 
necessary for a supplement to clarify terms, to seek comment on 
further aspects and help us with our consideration in going 
through the rulemaking process.
    Mr. Lucas. It would seem that the process is working.
    With that, Madam Chair, I yield back the balance of my 
time.
    Chairwoman Johnson. Thank you very much. Ms. Bonamici.
    Ms. Bonamici. Thank you, Chairwoman Johnson.
    Thank you to our witness for being here today.
    Chairwoman Johnson, I request unanimous consent to submit 
for the record a copy of The New York Times article from 
November 11, 2019, titled, ``EPA to Limit Science Used to Write 
Public Health Rules'' and also the EPA press release in 
response to that article from November 12, 2019.
    Chairwoman Johnson. Without objection.
    Ms. Bonamici. Thank you. The EPA's proposed rule titled 
``Strengthening Transparency in Regulatory Science'' isn't 
about transparency. It's an attack on sound science. We've had 
this conversation in this hearing room many times. Transparency 
is a laudable goal, and it can be accomplished through 
collaboration with and input from the scientific community. 
This rule, unfortunately, will detrimentally limit the science 
that EPA can rely on in regulatory decisionmaking and, if 
implemented, will have negative consequences for the EPA and 
its mission to protect public health and the environment and 
for every person who benefits from clean air and clean water.
    In his testimony before this Committee in September, 
Administrator Wheeler stated, ``We intend to issue a 
supplemental proposed rule to our science transparency 
regulation early next year.'' According to the record, I then 
asked if the supplemental rule would be published prior to 
2020. The Administrator clearly stated, ``I'm told early next 
year.''
    And then earlier this week The New York Times reported that 
the EPA draft supplemental proposed rule is currently headed 
for White House review. The EPA press release yesterday then 
stated that the final text has been submitted to the Office of 
Management and Budget for interagency review. And, Dr. Orme-
Zavaleta, you just confirmed that.
    Dr. Orme-Zavaleta. Yes.
    Ms. Bonamici. I'm concerned that the EPA was not 
transparent with Congress during this process. The OMB review 
of the proposed rule took only 4 days in the past, so assuming 
that the timing is similar, the supplemental proposed rule 
could very well be ready to publish before 2020. At best, the 
Administrator's testimony was misleading and at worst it was 
deliberately deceptive, and either is unacceptable.
    So Dr. Orme-Zavaleta--did I get that right?
    Dr. Orme-Zavaleta. You're doing great.
    Ms. Bonamici. Close?
    Dr. Orme-Zavaleta. You're----
    Ms. Bonamici. Please answer yes or no. Are you aware of the 
Administrator's testimony from when he was here in September?
    Dr. Orme-Zavaleta. Yes.
    Ms. Bonamici. And the timing in these press reports 
indicates that the final agency review (FAR) meeting has 
already taken place. So when Administrator Wheeler testified 
before the Committee on September 19, had the final agency 
review meeting already been scheduled?
    Dr. Orme-Zavaleta. So I'm not sure I'm entirely 
understanding final agency review.
    Ms. Bonamici. The final agency review meeting, had that 
already been scheduled?
    Dr. Orme-Zavaleta. So you're talking about the FAR process?
    Ms. Bonamici. Yes.
    Dr. Orme-Zavaleta. So we were in the--I think we hadn't 
even initiated--by the time of his testimony, I think it might 
have just--just been initiated in that FAR process, but we 
didn't resolve that until late last week, then--and then 
getting the draft supplemental to OMB.
    Ms. Bonamici. Well, the Administrator was here on September 
19.
    Dr. Orme-Zavaleta. So the FAR is completed now.
    Ms. Bonamici. Well, it's my understanding that the final 
agency review meeting was on September 30, 2019.
    Dr. Orme-Zavaleta. And I'm checking to see--yes.
    Ms. Bonamici. OK. So when the Administrator was here on 
September 19 it's reasonable to assume that he knew about the 
meeting that was scheduled on September 30. Is that correct?
    Dr. Orme-Zavaleta. I don't know that he knew that it was 
actually scheduled at that point in time, so I can't speak, but 
we can get further clarification from him regarding that 
particular testimony.
    Ms. Bonamici. Thank you.
    Dr. Orme-Zavaleta. But the FAR didn't complete until the 
week after.
    Ms. Bonamici. And I want to get another topic in. In light 
of the submission of the supplemental rule to OMB, please 
clarify the timeline for us. Will the supplemental rule be 
published prior to 2020?
    Dr. Orme-Zavaleta. I am not aware that it'll be published 
prior to 2020. We are anticipating after the beginning of the 
new year. The OMB process can vary in time, and the typical 
process can be anywhere from 90 days. So I can't say whether 
they'll have that completed prior to that.
    Ms. Bonamici. I also want to clarify, you mentioned 
something in your oral testimony that's not in your written 
testimony about retroactive application. In response to one of 
my questions during his testimony, Administrator Wheeler 
stated, ``Our proposal did not retroactively apply.'' Those 
were his words. But according to the news reports, the draft 
supplemental rule states that the rule would apply to all data 
and models, regardless of when the data and models were 
generated. The EPA press release states, ``The proposal and 
supplemental will not apply to any regulations already in 
place.''
    So please clarify for the record, even if, as the EPA 
stated yesterday, the proposal and supplemental will not apply 
to regulations already in place, does the language in the 
supplemental rule suggests that the EPA is still considering 
some type of retroactive application? And if so, what does that 
mean?
    Dr. Orme-Zavaleta. So the proposed rule--and this is the 
thing that we wanted to clarify with The New York Times article 
because I think it did get confused. So the supplement, you 
know, it does not apply to already-established rules and 
regulations. It does apply to dose-response data and models 
that could inform significant rules made in the future, 
including the data and models that were previously developed.
    Ms. Bonamici. Thank you for that clarification, which I 
find very concerning. The proposed rule and its implications on 
the EPA's statutory obligations warrant further consideration 
and scrutiny. So today I'm sending a letter requesting that the 
National Academy of Sciences, as an authoritative, independent, 
nonpartisan scientific organization work with the EPA to review 
the proposed rule.
    I yield back the balance of my time.
    Chairwoman Johnson. Thank you very much. Mr. Posey.
    Mr. Posey. Thank you, Madam Chair, for holding this hearing 
today on transparency, and I appreciate your attendance, Dr.--
--
    Dr. Orme-Zavaleta. Jennifer.
    Mr. Posey [continuing]. Orme-Zavaleta.
    Dr. Orme-Zavaleta. Yes, you're----
    Mr. Posey [continuing]. And I'm glad to see that the Agency 
is moving more toward better transparency. And I'm sad that it 
has been maligned by the media and others.
    In the past, EPA has relied upon ``secret studies'' to move 
forward with a particular political agenda. These studies were 
used to justify regulations that would have negatively affected 
thousands of people. For example, the EPA sought to regulate 
fine particulate matter or airborne dirt. This would have 
particularly hurt the agriculture business, which is the 
second-largest industry in the State of Florida. There would be 
no way to test the data used to make the regulation because it 
was secret. I have a problem with that obviously, and I believe 
we should have transparency. And any study funded with taxpayer 
funds should be made public.
    How do you believe the transparency and reproducibility 
will improve the quality and return on investment on federally 
funded scientific research?
    Dr. Orme-Zavaleta. So I think that as we look at federally 
funded scientific research, we are already making that 
information publicly available. Our published articles are made 
available through the NIH (National Institutes of Health) 
PubMed Central. Our data are made publicly available, so that's 
a provision that we are already doing.
    Mr. Posey. OK. Thank you. Has the EPA's Office of Research 
and Development incorporated reproducibility and transparency 
in federally funded research? And how has your office 
incorporated those measures?
    Dr. Orme-Zavaleta. So we provide the information, the data 
that we generate. We make that publicly available. And so 
that's where we're currently at. This particular rule is not 
final, and we're not implementing the rule as it has been 
proposed. But again, we're working hard to make sure that the 
data that we generate, the research that we conduct and 
implementing the--that particular provision, it's--also 
includes our external grants, as well as the rest of the 
Agency. So any research or any publication that the Agency 
generates, we make those publications available. We make the 
underlying data available. And that provision is now expected 
of our grantees as well.
    Mr. Posey. Well, thank you.
    Dr. Orme-Zavaleta. The main thing that I do want to 
highlight here, though, is that in doing so, we're going to 
continue to follow the applicable laws that protect PII and 
CBI.
    Mr. Posey. Thank you. I appreciate your forthrightness. 
I've had problems with the Agency in the past getting 
forthright answers from them. Suppose now I wanted to get a 
copy of a study that was previously deemed ``secret'' to make a 
law or rule, a law made by unelected, unaccountable, 
unrecallable bureaucrats. Would I now be able to get a copy of 
that secret study having any identification or personal 
information redacted of course? Would I be able to get a copy 
of the study now that they denied someone to see, say, 4 years 
ago?
    Dr. Orme-Zavaleta. I think I'd have to know some of the 
specifics, but I think we would work hard--if the study is 
published and available, we can provide that particular study 
and the underlying data that are highlighted in that particular 
study.
    Mr. Posey. Yes. If it was used to promulgate a rule, then 
it would probably be accessible now to the public even though 
it were not in the past?
    Dr. Orme-Zavaleta. So we're looking at regulations going 
forward, so a previously conducted study and the previous 
regulation, that record stands, but we're looking at 
regulations going forward. So this particular rule applies 
prospectively.
    Mr. Posey. So I still can't get a copy of a publicly paid-
for study that was used to promulgate a rule in the past?
    Dr. Orme-Zavaleta. It depends on how far past, but the 
docket that supports that rulemaking, that's what's publicly 
available now.
    Mr. Posey. I thank you. I yield back the balance of my 
time.
    Chairwoman Johnson. Thank you very much. Ms. Stevens.
    Ms. Stevens. Thank you, Madam Chair. I'd like to submit a 
letter for the record from Dr. Mona Hanna-Attisha, Founder and 
Director of the Michigan State University Hurley Pediatric 
Public Health Initiative. Dr. Hanna-Attisha also works as a 
pediatrician in Flint, Michigan.
    It's also worth teasing out some of what Dr. Hanna-Attisha 
has written before I get into my questions. Dr. Hanna-Attisha 
wrote that, quote, ``I know from my work as a pediatrician in 
Flint that when the EPA succeeds, people are protected, and 
when the EPA fails, people get sick. This is especially true 
for our most vulnerable communities and most desperately for 
our children both here in Flint and around the State. Let the 
story of the Flint water crisis serve as a tragic reminder of 
the consequences of undermining science, not only the science 
of water treatment but also the science of lead's 
neurotoxicity.''
    Quote, ``Unfortunately, the newly revised EPA proposal 
`Strengthening Transparency in Regulatory Science' undermines 
essential protections and established science-based 
decisionmaking processes. Shockingly, it does so to an even 
greater extent than the original proposed rule would have, 
despite overwhelming public opposition.''
    Dr. Orme-Zavaleta, do you acknowledge that the proposed 
rule would preclude the use of many types of studies that the 
EPA has used in the past to address environmental threats that 
disproportionately affect children, low-income populations, or 
both?
    Dr. Orme-Zavaleta. If I could please get some clarification 
because it sounds like Dr. Hanna was referring to the 
supplemental rule that leaked versus the proposed rule, and so 
is your question specific to the proposal or to the 
supplemental?
    Ms. Stevens. Well, it's to both frankly.
    Dr. Orme-Zavaleta. So I can't speak to the supplemental----
    Ms. Stevens. Yes.
    Dr. Orme-Zavaleta [continuing]. At this point in time, but 
again, you know, these echo many of the comments that we 
received, and it's because of some of these issues that we are 
going out with a supplemental to get further input and to 
provide some clarifications as we move forward.
    Ms. Stevens. Yes. While we here on the Science Committee 
protect and support transparency, so I appreciate your response 
and also wanted to ask, did the EPA consult the Office of 
Children's Health Protection before it wrote that the proposed 
rule could ignore the Executive Order 12898 or with the Office 
of Environmental Justice before it wrote the rule to ignore the 
E.O.? And the E.O., just for those in the audience, directs the 
EPA to identify and address disproportionately high and adverse 
human health or environmental effects.
    Dr. Orme-Zavaleta. So I was not part of the development of 
the proposed rule, and I can't really speak to which all--which 
programs were all engaged in----
    Ms. Stevens. OK. So we'll submit that for the record and 
get back. How can the EPA in part--how is this legally 
justified in terms of its decision to not perform an assessment 
on the proposed rule's adverse impacts on vulnerable 
populations? Is there an ability for you guys to provide legal 
justification, or is that something else we should submit for 
the record?
    Dr. Orme-Zavaleta. I think that would be better to submit 
for the record.
    Ms. Stevens. OK. And so then going forward with the 
supplemental draft, you know, if you could provide any specific 
opportunities or insights and ways in which you've engaged 
minority populations and children's health advocates to 
participate in the further rulemaking process, is that 
something that you can speak to at this time?
    Dr. Orme-Zavaleta. So in developing the supplemental, we 
did utilize an agency workgroup, which had representation 
across the Agency. I don't believe the Office of Children's 
Health identified a person to take part, but we did get cross-
agency input in reviewing all of the comments and determining 
where we needed further clarifications, further comment, as 
well as offering what we are--certain clarifications of terms 
and aspects. So that's what's going to be coming forward.
    Ms. Stevens. Well, I'd certainly like to recommend that the 
Agency gets in touch with Dr. Hanna-Attisha and her associates 
given that the largest public health crisis of our time, those 
voices would certainly be valued and recommended.
    And I'd also like to commend you, Dr. Orme-Zavaleta, for 
your very lengthy career in civil service at the EPA as a 
scientist. Thank you for being here with us today.
    Dr. Orme-Zavaleta. Thank you.
    Ms. Stevens. I yield back my time.
    Chairwoman Johnson. Thank you very much. Mr. Baird.
    Mr. Baird. Thank you, Madam Chair. I appreciate the witness 
being here today and your background and experience.
    You already mentioned The New York Times article, and I 
understand your address to that, you cannot probably comment on 
the supplemental rule, but I guess I'm wondering about, is 
there any scenario where whatever the version of the rule that 
might be finalized, this transparency rule would somehow 
invalidate the existing regulations?
    And you mentioned something about not going back or 
whatever the previous decision was based on that might not 
change previous decisions, and can you elaborate on any kind of 
a situation where that might invalidate existing rules? I guess 
what I'm trying to say is after you've made a rule and then, 
you know, your colleagues and so on do the research and 
reproducibility and replicability end up being validations. So 
if you had additional research that proved what the previous 
rule and decision was maybe in error, can you adjust that 
rulemaking----
    Dr. Orme-Zavaleta. So, again, this--this particular rule, 
once it's finalized, would apply prospectively to future rules 
and regulations. It would not undo existing rules and 
regulations. It's only looking forward. And I think in the case 
of some statutes, whether it's NAAQS (National Ambient Air 
Quality Standards) or a 6-year review of drinking water 
regulations, that would be an opportunity where new information 
can be considered in updating those particular activities, if 
that gets to what you're looking for.
    Mr. Baird. We're getting close. You're on the right track. 
My question is sometimes these rules end up impacting 
businesses and so on. The airborne rule for agriculture was one 
of those. I guess my question is, how fast can you make 
adjustments in the rule? I'm wondering if the process doesn't 
inhibit or----
    Dr. Orme-Zavaleta. Well, the Agency follows the statutory 
requirements in developing its different rules and regulations. 
But the other thing to keep in mind is, first and foremost, we 
are about protecting public health and the environment. And we 
want to make sure that our decisions are sound and will meet 
the mission of the Agency.
    Mr. Baird. So I understand, and maybe I'll rephrase this, 
once the rule is finalized and it's put in place, but then if 
new data was available or became available that made you want 
to modify that rule, how long would it take to make a change in 
the rule?
    Dr. Orme-Zavaleta. It would depend on----
    Mr. Baird. It would have to go back clear through the whole 
process?
    Dr. Orme-Zavaleta. So that would be in the policy side of 
EPA, and each would follow their statutory schedule of 
rulemaking and looking at the contaminants that they control 
under the different authorities. So it would follow that 
schedule. There wouldn't be any sort of increased schedule.
    Mr. Baird. So that could take a year or 2 years or what to 
make a----
    Dr. Orme-Zavaleta. It depends on----
    Mr. Baird. Whatever that policy is?
    Dr. Orme-Zavaleta. It depends on the particular--whether 
it's under the Clean Air Act, Clean Water Act, Safe Drinking 
Water Act, what have you. It would be that schedule that this 
rule would apply.
    Mr. Baird. OK.
    Dr. Orme-Zavaleta. OK.
    Mr. Baird. Thank you. I yield back.
    Chairwoman Johnson. Thank you very much. Mr. McNerney.
    Mr. McNerney. Well, I thank the Chairwoman, and I thank 
you, Dr. Orme-Zavaleta, for appearing today. I know you're in 
for some tough questions.
    The EPA cannot unilaterally decide to completely transform 
the way it uses science in its rulemaking. It needs to receive 
the authority from Congress, and it needs to justify the use of 
that authority. If the Agency cannot do that, the rule is not 
valid.
    In its May 2018 notice extending the public comment period, 
the EPA cited 5 U.S. Code 301. According to The New York Times, 
this is now the sole authority being cited by the Agency. Dr. 
Orme-Zavaleta, are you familiar with the notice that the EPA 
published in May 2018 which extended the public comment period 
and announced a public hearing on the proposed rule, and cited 
EPA's supposed authority under 5 U.S.C. 301?
    Dr. Orme-Zavaleta. So I'm aware that we extended the public 
comment period from the end of May until the middle of August, 
yes.
    Mr. McNerney. What about citing the EPA's supposed 
authority under that code?
    Dr. Orme-Zavaleta. So I'm going to have to defer that to 
our legal counsel if that's something you want to submit for 
the record, then we can respond that way.
    Mr. McNerney. Well, thank you. In reference to the proposed 
rule, let's talk about 5 U.S.C. 301. It's a two-sentence law 
that called the Federal Housekeeping Statute that was enacted 4 
years before the EPA was created. Are you aware of any 
executive department that has relied on this housekeeping 
statute to fundamentally overhaul its regulatory process?
    Dr. Orme-Zavaleta. So, again, I would have to defer to our 
general counsel.
    Mr. McNerney. Well, I have to advise you that the Committee 
staff made it clear to the EPA that you should be able to 
answer all questions on the proposed rule.
    Dr. Orme-Zavaleta. I cover a lot of topics, but I am not a 
lawyer.
    Mr. McNerney. Well, if the EPA's position is that it 
already has the authority to carry out this rule under 5 U.S.C. 
301, why is it promulgating the new rule now?
    Dr. Orme-Zavaleta. Again, I think that's something we'll 
have to follow up on.
    Mr. McNerney. OK. Well, I'm curious about how far the 
Agency could push the authority that it claims under this 
statute. Could the EPA invoke 5 U.S.C. 301 to consider only 
science published by industry?
    Dr. Orme-Zavaleta. Again, I'll have to defer that comment.
    Mr. McNerney. Could the EPA invoke 5 U.S.C. 301 to consider 
science differently in enforcing clean-air regulations within 
different States based on whether the State voted for or 
against President Trump?
    Dr. Orme-Zavaleta. Again, I think that's something that 
we'll have to follow up with you.
    Mr. McNerney. Will the EPA at least knowledge that 5 U.S.C. 
301 does not convey any authority under the rule that conflicts 
with existing statutory enforcement obligations?
    Dr. Orme-Zavaleta. And I'll have to defer that as well. So 
anything on the authority, sir, I'm not going to be able to 
address.
    Mr. McNerney. Well----
    Dr. Orme-Zavaleta. That's not my area of expertise.
    Mr. McNerney [continuing]. The EPA was notified that you 
today would have to answer all these questions.
    Dr. Orme-Zavaleta. I apologize if that was a 
misunderstanding, but that's beyond my particular expertise.
    Mr. McNerney. All right. Well, I'm going to have to yield 
back. Thank you.
    Chairwoman Johnson. Thank you very much. Mr. Murphy.
    Mr. Murphy. Thank you, Madam Chairman. And thank you, 
Doctor, for your service. It's a testament to dedication in 
science that we have great people in government that have 
dedicated their lives to that, so thank you very much.
    I've been in medicine for 30 years and done a different 
type of dedication, and I've read and continue to read many, 
many medical journals, as I'm sure you do. And I think it's 
important that people know that when you and I read journals, 
we look at articles, we look at studies with a very, very 
discerning eye. I personally don't believe anything in the 
literature until I believe it. And I think that's the way our 
scientists have pointed out.
    And so it bothers me to think or imply that folks would 
think that the people in the EPA would do anything less. I 
think scientists, we hold ourselves to a different standard, 
that we look for the true objective facts, and we base that 
upon that. So I thank you for the work that you're doing in 
that.
    I will ask one question. Have you by any chance had a 
chance to review the news release from the EPA yesterday?
    Dr. Orme-Zavaleta. Yes, I saw it after it came out.
    Mr. Murphy. OK. In quick summary, it talks about The New 
York Times and several glaring inaccuracies of their article. 
And I think, to be very honest with you, it's just seemingly a 
theme that goes on around here about reckless reporting, 
inaccurate reporting, and flat out lying.
    And so I wondered, you know, since you have read this, it 
talks about false information being stated, things that are bad 
reporting, things that are not true. I wondered if you might 
have a comment for the Committee about this news release and 
how you feel. Is this an accurate depiction of the inaccuracies 
put out by The New York Times?
    Dr. Orme-Zavaleta. Well, I think the key clarification from 
the press release, again, is just to highlight that this is a 
supplement. It's not a new rule. It is a supplement to what was 
proposed, and the Agency wanted to clarify terms. We wanted to 
also get additional comment as we continue our deliberations in 
finalizing the rule. I think that was one of the key pieces of 
clarification.
    The other key clarification, again, was to note that this 
rule applies prospectively to new rules and regulations, not to 
the past rules and regulations.
    Mr. Murphy. Yes, thank you. Do you think there's anybody at 
the EPA that does not have the interest of the American people 
at heart?
    Dr. Orme-Zavaleta. I have not come across anyone at EPA--
the thing that is remarkable about all of the Agency employees 
is their dedication to the mission of the Agency and protecting 
public health and the environment.
    Mr. Murphy. Thank you. I think that we owe a great debt to 
the EPA for keeping the country safe, keeping our waterways 
safe, keeping what we take in safe. We're not perfect in this 
regard, and there are a lot of times that we go back and look 
at things that we could've done differently. So I appreciate 
that.
    You know, you talked about in your prepared testimony how 
the rulemaking was just one step in a long effort to improve 
scientific integrity and transparency. Can you expand upon that 
a little bit? Has this been a bipartisan effort? Tell me a 
little bit more or tell us a little bit more about how this 
process really has been one of collectiveness.
    Dr. Orme-Zavaleta. Well, again, I think, as I noted 
earlier, as science has come across increased scrutiny, we have 
been working hard to build public trust in the quality of our 
science, and we do that primarily through strong quality 
assurance, strong, independent expert peer review of our work, 
as well as a strong scientific integrity program.
    Combined with that, building public trust is also helping 
to enable the public to understand what information was used in 
the decisions the Agency makes. So if they choose, they can go 
back and try to understand how we came to the conclusions that 
we came to. And that's where the transparency piece comes in.
    Mr. Murphy. Thank you. Just one final question. Is non-
government-funded research currently subjected to the same 
transparency requirements that the EPA's intramural research 
and extramural grants have?
    Dr. Orme-Zavaleta. So this particular rule--the proposed 
rule applies only to EPA.
    Mr. Murphy. OK. All right. Thank you, Madam Chair. I'll 
yield back my time.
    Chairwoman Johnson. Thank you very much. Mr. Tonko.
    Mr. Tonko. Thank you, Madam Chair, and thank you, Dr. Orme-
Zavaleta, for joining us.
    For 5 years, I have fought against these deceptively named 
science transparency proposals. I said this when we were 
debating the Secret Science and HONEST Acts, and it's still 
true today. These efforts pay cheap lip-service to improving 
scientific integrity and transparency, but their true purpose 
is to undermine the decades of sound science on which EPA 
relies to protect our air, water, and the health and safety of 
the American people. Any form of this rule, any form 
essentially guarantees that political agendas are given more 
weight than science in EPA rulemaking.
    I asked EPA to withdraw this rule at the summer 2018 public 
comment session. I and others pointed out that its effect would 
be to undermine necessary science and endanger public health. 
When the supplemental rulemaking came to light, I hoped this 
meant that EPA was re-evaluating. But based on reports, this 
EPA is going down that same path and will endanger the health 
and safety of millions of Americans for many generations to 
come.
    So, Dr. Orme-Zavaleta, the proposed rule tracks closely 
with the Secret Science Reform Act of 2015, legislation 
previously debated by this Committee. In fact, the language is 
virtually identical. Congress has repeatedly considered this 
legislation, and time and time again we have declined to move 
it forward.
    Out of the Secret Science Reform Act of 2014, of 2015, or 
the HONEST Act of 2017, how many ever became law?
    Dr. Orme-Zavaleta. I guess I'm not sure--of those 
particular that you just cited, I don't believe Congress passed 
a law----
    Mr. Tonko. OK. So the answer is zero. To your knowledge, 
were EPA officials aware that Congress had already rejected the 
Secret Science and HONEST Acts?
    Dr. Orme-Zavaleta. I would assume so, but I don't know for 
a fact.
    Mr. Tonko. How many comments were issued with concerns 
about the rule?
    Dr. Orme-Zavaleta. So, again, we received nearly 600,000 
comments, about 9,200 which were unique. And, as I noted 
earlier, you know, I think many of the comments supported the 
concept of transparency, and where they differed was in the way 
that we approach that.
    Mr. Tonko. OK. And did any comments raise the issue that 
this rule would endanger the health and safety of Americans?
    Dr. Orme-Zavaleta. We received a number of comments from 
all sectors, a variety of different topics, and so those were 
similar to some of the comments that we received.
    Mr. Tonko. That they did raise the concern of health and 
safety of Americans?
    Dr. Orme-Zavaleta. Yes.
    Mr. Tonko. Thank you. Have any EPA officials expressed 
concern that this rule would endanger the health and safety of 
Americans?
    Dr. Orme-Zavaleta. I don't believe we've come into that 
conversation yet. I mean, Administrator Wheeler has asked that 
we continue to proceed with the development of this rule.
    Mr. Tonko. But do you know of any officials at EPA that 
expressed concerns?
    Dr. Orme-Zavaleta. I do not know, no.
    Mr. Tonko. You do not know. Have career staff expressed 
concerns about being left out of the process of drafting the 
proposed rule?
    Dr. Orme-Zavaleta. I haven't heard about specific comments 
related to the drafting, but when we were asked to take up that 
proposed rule and move it forward through the process, we are 
ensuring that career staff are engaged in our workgroup process 
so that we can go through the comments and go through the 
clarifications and the decisions moving forward.
    Mr. Tonko. Right. To be involved but you then again do not 
know of any staff that expressed concerns about being left out?
    Dr. Orme-Zavaleta. Personally, no.
    Mr. Tonko. When was the decision made to write a 
supplemental proposed rule? When did you learn about it, and 
how many career staff are now involved in drafting it, 
including yourself?
    Dr. Orme-Zavaleta. So, again, as we worked through from the 
public comment period, we've had a career-led effort in looking 
at the comments and trying to understand some of the complex 
issues that were raised. Many of these issues led us to 
recommend to the Administrator the benefit of a supplemental to 
provide clarifications and further discussion of the certain 
aspects of the rule. The Administrator agreed that it would be 
important to do that. So we're moving forward, and we'll be 
looking to get further comment on that rule when it goes out.
    Mr. Tonko. Thank you. And many people fear that this rule 
will endanger the health and safety of Americans. If Americans 
are sickened as a result of this rule, does EPA have a plan to 
provide care?
    Dr. Orme-Zavaleta. So, again, EPA is looking to protect 
public health and the environment.
    Mr. Tonko. But Americans are sickened as a result of this 
rule, do they have a plan to provide care?
    Dr. Orme-Zavaleta. We've got a ways to go to see what the 
final rule is going to look like. We have lots of information 
that we are considering. Decisions have not been made what that 
final rule will look like.
    Mr. Tonko. So I assume they don't have a plan. And if 
Americans are sickened or die as a result of this rule, who 
will be held accountable?
    Dr. Orme-Zavaleta. Yes, I--you know, it's----
    Mr. Tonko. Who would be----
    Dr. Orme-Zavaleta. It's hard to say.
    Mr. Tonko [continuing]. Held accountable?
    Dr. Orme-Zavaleta. It's hard to say. Again, we don't know 
what the final rule is going to look like.
    Mr. Tonko. Who's the top political EPA appointee overseeing 
the drafting of the supplemental proposed rule?
    Dr. Orme-Zavaleta. Well, the Administrator is the top 
official.
    Mr. Tonko. Thank you. With that, Madam Chair, I yield back.
    Chairwoman Johnson. Thank you very much. Mr. Babin.
    Mr. Babin. Yes, ma'am. Thank you very much, Madam Chair.
    Dr. Orme-Zavaleta, thank you for being here today, and I 
thank you for your professional career. I appreciate it.
    I'd like to continue this same line that Dr. Murphy had 
started a while ago. As several of my colleagues have already 
mentioned, our discussion here today is overshadowed by the 
recent New York Times article that provided a long list of 
comments and a leaked copy of an earlier draft of the 
supplemental rule.
    I have to say that I'm very disappointed that we're 
allowing the work of one reporter to characterize our 
discussion here today, particularly when we have yourself, 
followed by a panel of expert witnesses, to talk about the 
broader issue of improving scientific transparency.
    But since we've decided to make a New York Times article 
the centerpiece of our discussion, I think it's only fair that 
we include the EPA's rebuttal to that article, which Dr. Murphy 
had already brought up. And without objection, if it's not 
already done, I'd like to enter that into the record if that's 
OK, Madam Chair.
    Chairwoman Johnson. Without objection.
    Mr. Babin. Thank you.
    I know you've already mentioned it, and I'd like for you to 
elaborate a little bit more. Do you think that The New York 
Times article accurately portrayed the draft supplemental rule 
that was leaked?
    Dr. Orme-Zavaleta. So I think the article confused a few 
aspects.
    Mr. Babin. OK. All right. Thank you. Do you think this 
Committee would be better served if we, as you suggested in 
your prepared testimony, received briefings on the supplemental 
rule once it is published through the appropriate channels 
instead of wasting our time debating an outdated version?
    Dr. Orme-Zavaleta. So, again, I'm happy to be here today to 
help answer questions related to the proposed rule, and we're 
happy to follow up with briefings once the supplemental is 
publicly available.
    Mr. Babin. OK. Well, will you commit today to work to 
schedule those briefings as soon as the supplemental rule is 
published?
    Dr. Orme-Zavaleta. I'll defer to our congressional affairs 
staff, and they'll follow up.
    Mr. Babin. OK. And do you have any reason to believe that 
the proposed or draft supplemental rule would somehow make it 
more difficult for the EPA to carry out its regulatory mission?
    Dr. Orme-Zavaleta. So just to note, the supplemental is a 
supplement----
    Mr. Babin. Right.
    Dr. Orme-Zavaleta [continuing]. To the proposed rule 
seeking additional clarifications and modifications to the rule 
and getting comment back on that.
    Mr. Babin. OK. Well, The New York Times article said just 
the opposite, so will this supplemental make it more difficult 
to----
    Dr. Orme-Zavaleta. So that's one of the clarifications that 
we wanted to provide, that this is not a new rule. It is a 
supplement to what was proposed where we are seeking some 
clarification of terms and other aspects of the rule and 
getting further comment back from the public.
    Mr. Babin. Well, when I read The New York Times article, it 
didn't come across like that at all. Madam Chair, I'm going to 
yield back. That's all I have. Thank you. Thank you very much.
    Chairwoman Johnson. Thank you very much. Mr. Casten.
    Mr. Casten. Thank you. Dr. Orme-Zavaleta, thank you so much 
for coming today and for your decades of service to the EPA.
    If my cell phone is any predictor, this is not the 
Committee hearing that most of the country is watching today. 
But I want to suggest there's a parallel. Our colleagues over 
in the Intelligence Committee right now are defending the 
Constitution from the White House. And I sit here watching this 
and thinking we are right now defending the enlightenment from 
the White House. And I'm not being hyperbolic. When we 
politicize the Constitution, we put our republic at jeopardy, 
and when we politicize science, we put our species in jeopardy.
    You cannot be happy that you're here. You cannot be happy 
that your leadership has put you in a position to defend an 
anti-scientific history. But make no mistake, Union of 
Concerned Scientists has reported that the idea behind this 
rule came from a 1996 memo from Chris Horner to R.J. Reynolds--
Chris Horner, who was part of Trump's transition team at EPA; 
Chris Horner, who is a tinfoil-hat-wearing climate denier. And 
he wrote in his memo in 1996, ``Because there is virtually no 
chance of affecting change if the focus is environmental 
tobacco smoke, our approach is one of addressing process as 
opposed to scientific substance.'' He then went through and 
recommended essentially what you're proposing here today, what 
your Agency is proposing here today.
    Madam Chair, I'd like unanimous consent to enter this memo 
into the record.
    Now, in The New York Times report, it said that the 
supplemental proposed rule is considering applying the policy 
retroactively so that all past scientific research could be 
excluded by EPA unless the underlying data is made publicly 
available. The EPA response to this--which you've been talking 
about--largely dodges the important points.
    So, number one, EPA said in a release that, quote, ``The 
proposal and supplemental will not apply to any regulations 
already in place.'' Yes or no, is it within EPA's authority to 
review and update existing regulations at its own discretion?
    Dr. Orme-Zavaleta. I believe they follow the statutory 
schedule.
    Mr. Casten. So it's a yes?
    Dr. Orme-Zavaleta. It's a maybe.
    Mr. Casten. You have that discretion. Aren't there mandated 
timelines to update certain existing regulations like those 
issued under the National Ambient Air Quality Standards?
    Dr. Orme-Zavaleta. I believe the statutes do require a 
regular schedule for updating.
    Mr. Casten. OK. So given that EPA can reconsider any 
regulations it deems necessary and the mandatory 
reconsiderations--is it safe to say that any existing 
regulation can be ultimately rewritten within the bounds of 
this proposed rule should it be finalized?
    Dr. Orme-Zavaleta. Should this rule be finalized, then it 
will apply prospectively to new rules and regulations.
    Mr. Casten. But those old rules are going to come up for 
renewal under what we just talked about, so it's fundamentally 
disingenuous to assert, as EPA has, that the rule will not be 
applied retroactively to existing regulations. And----
    Dr. Orme-Zavaleta. It's still applying prospectively.
    Mr. Casten. But all those rules are coming up for renewal. 
This----
    Dr. Orme-Zavaleta. And the Agency may decide to update--a 
lot of it is driven by what new information becomes available.
    Mr. Casten. And we are asked to trust that people led by 
science deniers are going to make that decision right. Look, 
this is painful. And we are sitting at a moment where none of 
this assault on science happens if people in your shoes stand 
up. If and when you stand up, we've got your back, but please 
stand up.
    Dr. Orme-Zavaleta. Thank you.
    Mr. Casten. Thank you. I yield back.
    Chairwoman Johnson. Thank you very much. Mr. Balderson.
    Mr. Balderson. Thank you, Madam Chair. And, Doctor, thank 
you very much.
    Doctor, it's my understanding that the EPA currently has 
transparency rules in place for internal research in EPA 
grants. Can you elaborate on what those requirements are today?
    Dr. Orme-Zavaleta. So related to public access, which is 
different from a transparency rule, but it's public access to 
information. And, so, yes, that's currently in place where our 
research and the publications from that research are made 
publicly available, along with the underlying data for that, 
that's now extended across the Agency, as well as applying to 
our external grants community.
    Mr. Balderson. OK. Thank you. A follow-up, are there 
policies to ensure the protection of personal or sensitive data 
within these transparency requirements?
    Dr. Orme-Zavaleta. The Agency does have laws and 
regulations that do provide for the protection of PII and CBI.
    Mr. Balderson. OK. Thank you. Is there any reason that non-
government-funded research could not also be subject to similar 
transparency requirements?
    Dr. Orme-Zavaleta. So the public access information applies 
more broadly. This particular transparency rule applies just to 
EPA.
    Mr. Balderson. OK. Thank you. When finalizing the science 
transparency rule will the EPA ensure the all-important studies 
underlying significant regulatory actions at the EPA regardless 
of their source are subject to a transparent review by a 
qualified scientist?
    Dr. Orme-Zavaleta. So we go through the scientific process, 
and our information that we develop, the science that we use, 
we look for external peer review to help ensure the quality of 
that science. In agency decisionmaking and rulemaking process, 
it does go through a public notice and comment period.
    Mr. Balderson. Doctor, thank you for your time. And, Madam 
Chair, I yield back my remaining time.
    Chairwoman Johnson. Thank you very much. Mr. Foster.
    Mr. Foster. Thank you, Madam Chair, and thank you, Dr. 
Orme-Zavaleta, for everything. You know, I read some interview 
you had online, and you talked about growing up I think in the 
Cleveland area.
    Dr. Orme-Zavaleta. I did.
    Mr. Foster. And I got my Ph.D. in the salt mine under 
Mentor Harbor, and we'd go swimming in the lake. And you 
probably know what a Tittabawassee trout is from----
    Dr. Orme-Zavaleta. Actually, I don't.
    Mr. Foster. You don't, OK. All right. There's a song about 
it I think having to do with ``burn on big river''----
    Dr. Orme-Zavaleta. Oh, yes.
    Mr. Foster [continuing]. Which you're probably familiar 
with. Yes.
    I thank you for your career.
    I'd like some clarification if I could on the prospective 
nature of the proposed rule. So under the proposed rule change, 
might it be possible that during a rule update, scientific 
studies that had previously been accepted as valid scientific 
input for the original rule might be rejected for the purposes 
of the rule update?
    Dr. Orme-Zavaleta. So that's also part of the kinds of 
comments that we received, and that's currently what's being 
discussed and debated. So we'll have to see how all of this 
weighs as we work toward finalizing that rule and what that 
final rule----
    Mr. Foster. So the answer is possibly yes with the current 
state of deliberation?
    Dr. Orme-Zavaleta. I think it's one of a number of comments 
that we're still working through.
    Mr. Foster. OK. So something as simple as a change in the 
data retention requirements between the time it was originally 
published and current data retention requirements might--
might--cause the science to be rejected?
    Dr. Orme-Zavaleta. Yes, I don't know about the data 
retention. That's a little more detailed than I think----
    Mr. Foster. Yes, well, the general issue that we've been 
wrestling with, you know, for the last several years is this 
whole narrative about secret science and honest science and so 
on, you know, to my mind represents a deliberate blurring 
between--and of distinctions between science that's 
irreproducible due to, you know, statistical or procedural 
errors or science that is not reproducible because it's based 
on confidential PII or CBI that really shouldn't be made 
public. Science that's based on natural experiments, things 
that just happen naturally, volcano eruptions, you know, things 
like that, and also manmade ones such as, say, the BP blowout 
that, you know, where very valid science was extracted using an 
experiment that probably should not be repeated.
    And, finally, valid experiments that have been performed 
and research that's been performed in the past at a time when 
the data retention requirements were different, you know, I 
very much appreciate when you read Science Magazine these days 
there's backup information that you can see at the end of the 
article.
    And it's good that we've moved that way, but some of the 
best science, things like the Harvard Six Cities studies, if 
that is at risk, then people's lives are at risk. And I think 
to the extent that you're even involved in the final decisions 
over this, I urge you to stick up for retaining science, the 
best available science.
    And, you know, as was mentioned, you know, Congress has 
considered and rejected a lot of these, you know, secret 
science and honest science proposals for good reasons. Can you 
understand why we might not be comfortable with having the 
final call on these being made by an coal lobbyist?
    Dr. Orme-Zavaleta. So, again, I think what you raise I 
think highlights a number of the comments that we received. 
There's a lot of confusion about what some of these terms 
meant, and that's part of the reason that we are looking to a 
supplemental to provide some clarification, provide some 
modifications, and seek comment on additional aspects of this.
    We're going to go through the rulemaking process. We're 
currently at the interagency review of the supplement. The 
information that comes in from that, we will then take into 
consideration as we work through developing. So these are 
comments that we are all grappling with right now.
    Mr. Foster. Yes. Now, would you characterize the 
formulation of the draft rule, which has been, you know, 
discussed, as something that is bottom-up where the scientific 
staff, the career people in the EPA have come up with the first 
drafts and then these are looked over and approved by the top? 
Or would you characterize it as top-down where the political 
appointees consult with whoever they consult with, come up with 
a draft, and then you're at best asked to comment on----
    Dr. Orme-Zavaleta. So, again, I was not engaged in the 
drafting of the proposed rule.
    Mr. Foster. So that happened at a level above you in the 
EPA?
    Dr. Orme-Zavaleta. Or outside of me, yes.
    Mr. Foster. Or outside of you. And so above you in the org 
chart are all political appointees at this point?
    Dr. Orme-Zavaleta. I report to the Acting Deputy 
Administrator.
    Mr. Foster. So everyone above yo--is the people involved in 
drafting a----
    Dr. Orme-Zavaleta. You know, we'd be happy to follow up if 
you'd like more information on the development of the proposal. 
We can follow up with you on that.
    Mr. Foster. OK. Thank you. I'm out of time and yield back.
    Dr. Orme-Zavaleta. Yes.
    Chairwoman Johnson. Thank you very much. Mrs. Fletcher.
    Mrs. Fletcher. Thank you, Chairwoman Johnson.
    And, Dr. Orme-Zavaleta, thank you for being here again 
before this Committee.
    Many scientific, academic, and public health and nonprofit 
organizations have formally expressed concern or opposition to 
the proposed rule, including, among others, the American Heart 
Association, the American Lung Association, the American 
Academy of Pediatrics, Children's Environmental Health Network, 
American Association for the Advancement of Science, the 
National Academies, the American Medical Association, the 
Association of American Medical Colleges, which has expressed 
its concern in writing. And I would like unanimous consent to 
enter their letter expressing objection into the record.
    The list goes on and on and on. And so I want to ask you a 
few questions about the comments that you've received from 
these institutions. You've worked at the EPA for 40 years, and 
over the course of your career I assume that you've encountered 
these groups or groups like them and worked with them on many 
occasions. Do you believe that they are good-faith advocates 
for scientific research and public health?
    Dr. Orme-Zavaleta. I think many of the people that 
submitted comments, whether they are professional associations 
or others, all submitted those in good faith.
    Mrs. Fletcher. And we can agree that the organizations with 
which you're familiar and referencing, they perform worthwhile 
work in this area?
    Dr. Orme-Zavaleta. For some of those professional 
associations, yes.
    Mrs. Fletcher. So some of their concerns about the rule, 
two of the quotations that I've seen repeatedly are that they 
restrict the use of the best available science, that that was 
one outcome of the rule, and that it will adversely affect 
decisionmaking processes. Are they wrong in that assessment?
    Dr. Orme-Zavaleta. So they raised a number of points, and 
we are looking at those very closely, very carefully as we 
consider, you know, the future development, future steps of the 
rulemaking process.
    Mrs. Fletcher. So later this morning in the next panel the 
CEO of the Michael J. Fox Foundation will testify about that 
foundation's concerns regarding the rule. And based on the 
written testimony that he submitted, he'll say that the rule 
puts individuals at great risk of having their Parkinson's or 
other diagnoses exposed if they participate in clinical 
studies. Now, certainly, that is a concern for my constituents. 
It's a concern for the researchers. We want to encourage these 
kinds of studies, and that concern is something that I think 
Americans share.
    And on another issue, you know, as I'm sure you're aware, 
the EPA may be working on setting a maximum contaminant level 
for PFAS in the near future, and studies to date have revealed 
serious concerns and serious health problems associated with 
these chemicals. But the majority of what we know about PFAS 
contamination and the adverse health effects comes from studies 
that rely on personal information and health information of 
individuals.
    So, currently, the scientists don't share that data for 
ethical and legal reasons.
    Dr. Orme-Zavaleta. Right.
    Mrs. Fletcher. Shouldn't the EPA reconsider the rule that 
would threaten to expose the personal information and could 
have a chilling impact both on participation and on research 
overall?
    Dr. Orme-Zavaleta. Yes, so we appreciate all the comments 
that we received on this, and we took that very topic to our 
Science Advisory Board for review. They provided some comments 
through that consultation process on how the Agency can 
continue to protect PII, as well as CBI, and how we can use 
that information in our decisionmaking process. So all of this 
is now coming in for our consideration as we go forward.
    Mrs. Fletcher. And are those protections for PII and CBI 
contained in the supplement to the rule?
    Dr. Orme-Zavaleta. So, again, I can't speak to the 
particulars of what's in the supplement at this point in time. 
Again, the supplement is something that we're looking to help 
clarify terms, as well as talk through additional modifications 
and gaining further input.
    Mrs. Fletcher. So with these principal concerns about 
participation, about PII, CBI, about getting the best possible 
science, are you also aware that, in addition to the diverse 
organizations and the other folks who have weighed in on these 
issues, that the CBO, working on the Secret Science Reform Act 
of 2015, discussed by my colleague Mr. Tonko earlier, that that 
would cost EPA approximately $250 million a year for several 
years going forward? And given the concerns of the scientific 
community, the concerns about the expense of complying with 
this rule, what is the likelihood or the possibility that EPA 
will abandon this rule in its entirety?
    Dr. Orme-Zavaleta. So I don't believe the--so we received a 
number of comments related to potential costs, and I'm aware 
that there's been some earlier conversations. Again, all of 
that is going to be coming into our deliberations and our 
discussions as we finalize the rule. I don't believe that the 
committee's workgroup has gotten to that particular issue just 
yet, but that's something that will be weighed as we go 
forward.
    Mrs. Fletcher. Thank you very much. I've gone over my time, 
so, Madam Chairwoman, I yield back.
    Chairwoman Johnson. Thank you very much. Ms. Wexton.
    Ms. Wexton. Thank you, Madam Chair. Thank you, Doctor, for 
joining us again today.
    I want to return to the question of the statutory authority 
that EPA is citing in support of its proposed rule, 
specifically 5 U.S.C. 301, which we are putting on the board. 
So that section applies to the head of an executive department 
or military department may prescribe regulations and so on and 
so on. So is the EPA an executive department or a military 
department?
    Dr. Orme-Zavaleta. So EPA is in the executive branch.
    Ms. Wexton. OK.
    Dr. Orme-Zavaleta. It's an independent agency in the 
executive branch.
    Ms. Wexton. All right. Were you aware that 5 USC 301 also 
specifically outlines the executive departments that are 
included under that statute?
    Dr. Orme-Zavaleta. Yes, so similar to the earlier 
questions, I'm going to have to defer any questions related to 
the statutory authority because that's beyond my area of 
expertise, but we can follow up with you on that.
    Ms. Wexton. But we can agree that the EPA is not a military 
department?
    Dr. Orme-Zavaleta. Not that I am aware of.
    Ms. Wexton. OK. And then do we have the graphic of 101? So 
these are the executive departments that are specifically 
outlined as pertaining to 301's requirements. Can you show me 
where on there we have anything about the EPA?
    Dr. Orme-Zavaleta. So I think you raise a good point, and 
that's something that we'll consider going forward and we'll 
have our general counsel review that.
    Ms. Wexton. OK. It's concerning to me that the EPA is using 
this particular statute to justify this rulemaking and don't 
even have a shred of other authority in support of it. This is 
a basic housekeeping rule. It's really intended for internal 
operations for certain agencies, not for outward-facing big 
things like this proposed rule. So if they're planning to cite 
this again, I would suggest that they come up with something 
better.
    Dr. Orme-Zavaleta. Well, thank you. I appreciate the 
comment.
    Ms. Wexton. So switching gears just a little bit right now, 
the proposed rule has a provision that would allow the 
Administrator to provide case-by-case unilateral exemptions to 
the rule. Is that correct?
    Dr. Orme-Zavaleta. So that's in the proposed rule, yes.
    Ms. Wexton. OK. Does that cause you any concern at all?
    Dr. Orme-Zavaleta. Well, it's a topic that we heard a 
number of comments on, and that's something that's currently 
being discussed further.
    Ms. Wexton. What sort of guardrails or regulations or rules 
are there for that case-by-case exemptions?
    Dr. Orme-Zavaleta. I don't know of existing ones now, but I 
will note that in the Agency's rulemaking process, you know, 
there is a briefing. There are decisions that are made by the 
EPA Administrator, so the EPA Administrator already makes a 
number of decisions related to----
    Ms. Wexton. But this exemption provision for the proposed 
rule would apply only to the EPA Administrator, who would be 
able to exempt studies and science from the rule. Is that 
correct?
    Dr. Orme-Zavaleta. That's what's in the proposed rule, yes.
    Ms. Wexton. OK. And the EPA Administrator is a political 
appointee, is that correct?
    Dr. Orme-Zavaleta. And Senate-confirmed, yes.
    Ms. Wexton. And how long have you served with this EPA? How 
long have you been----
    Dr. Orme-Zavaleta. Thirty-eight years.
    Ms. Wexton. OK. And in your 38 years at the EPA, have you 
ever seen any instance where an EPA administrator was given 
this kind of authority to overrule career staff's decision to 
consider a particular study during the rulemaking process?
    Dr. Orme-Zavaleta. I haven't been involved in all of those 
types of decisions with administrators over all that time.
    Ms. Wexton. With the understanding that you have not been 
involved in every decision that's been made over the last 38 
years, can you recall a time that that the Administrator has 
been allowed to overrule----
    Dr. Orme-Zavaleta. Yes, I can't really speak to that 
because I haven't been engaged in that.
    Ms. Wexton. But can you cite an example?
    Dr. Orme-Zavaleta. Not that I'm aware of.
    Ms. Wexton. OK. Very good. As a career scientist, how would 
you feel personally if a political appointee told you that you 
could arbitrarily consider some scientific research in your 
work but not other scientific research?
    Dr. Orme-Zavaleta. As a career scientist, I would have a 
conversation and make the case, but the Administrator makes the 
policy decision.
    Ms. Wexton. OK. Thank you very much. I have no further 
questions. I'll yield back.
    Chairwoman Johnson. Thank you very much. Ms. Sherrill.
    Ms. Sherrill. Thank you. And, Dr. Orme-Zavaleta, our 
soldiers and their families make great sacrifices on our 
behalf, and we have a duty to take care of them. Military 
operations and facilities present unique environmental 
challenges, as I'm sure you know. And the Department of Defense 
(DOD) funds a great deal of important public health research 
relevant to its operations. Are you aware that the DOD was one 
of the 600,000 public commenters in response to the proposed 
rule?
    Dr. Orme-Zavaleta. Yes.
    Ms. Sherrill. And are you aware that in its public comment 
the DOD criticized the fundamental premise of the rule by 
saying, quote, ``We do not believe that failure of the Agency 
to obtain a publications underlying data from an author 
external to the Agency should negate its use,'' quote?
    Dr. Orme-Zavaleta. So I have not read all 600,000 comments 
that came in. I'm aware that they submitted comments, but I 
think those are the types of comments that our workgroup is 
going through right now.
    Ms. Sherrill. So does it concern you that the DOD thinks 
the EPA's position is incorrect?
    Dr. Orme-Zavaleta. I think it's one of many comments that 
we'll be going through. We heard from a wide variety of 
different sectors, and those are things that we will be looking 
at seriously going forward.
    Ms. Sherrill. And the DOD also wrote that the EPA should 
not apply the rule retroactively. Why is the EPA even 
considering retroactive application in the face of DOD's 
opposition?
    Dr. Orme-Zavaleta. So, again, to be clear, this rule does 
not apply retroactively. It applies prospectively to future 
rulemakings.
    Ms. Sherrill. But it does appear you won't be using some 
prior studies in future rulemakings, so it will----
    Dr. Orme-Zavaleta. We don't know that at this point.
    Ms. Sherrill. And so the DOD wrote in its comments that, 
quote, ``It appears as if the EPA may have overlooked the 
advancement of science through open publication as a compelling 
interest,'' end quote. Can you walk me through why the EPA sees 
it fit to disregard the importance of open science, as laid out 
by the Defense Department in its public comment?
    Dr. Orme-Zavaleta. So I think, again, I don't know the 
specifics of what DOD raised. I would note that, however, in 
the rulemaking process, there is an interagency review step of 
which DOD is one of those agencies that has a chance to review 
and comment during that time.
    Ms. Sherrill. I would implore you to look carefully and 
listen carefully to what they say.
    Can you explain why it seems that the DOD is concerned with 
protecting the health and wellness of our Nation's soldiers and 
families, and yet it appears from some of what we're seeing 
from this rule that the EPA is not as concerned with that?
    Dr. Orme-Zavaleta. So EPA's mission, again, is to protect 
public health and the environment, and that applies for 
civilian and military.
    Ms. Sherrill. So it is a huge concern, I would think, that 
the DOD has some real concerns with this proposed rule. Dr. 
Orme-Zavaleta, can you confirm that the EPA will fairly 
consider any further comments submitted by the DOD about the 
supplemental proposed rule? Because our soldiers and families 
really deserve nothing less.
    Dr. Orme-Zavaleta. Yes, we are looking seriously at all the 
comments that we received, and so additional comments that come 
in, we are weighing very carefully.
    Ms. Sherrill. Thank you, and I yield back.
    Chairwoman Johnson. Thank you very much. Ms. Horn.
    Ms. Horn. Thank you, Dr. Orme-Zavaleta, for your dedication 
and your work.
    We've had some important questions I think raised today. I 
want to dig in a little bit more about the processes that are 
currently in place and the ability to understand and interpret 
the data. As a scientist, you've no doubt gone through years of 
training to understand the data that comes in front of you and 
to be able to make use of it, correct?
    Dr. Orme-Zavaleta. Yes.
    Ms. Horn. And would you say that on average regular members 
of the public could take raw data and correctly interpret that 
information without proper training or insight?
    Dr. Orme-Zavaleta. So, again, these were similar to some of 
the comments that we've received in trying to get better 
clarification of data.
    Ms. Horn. So I'm going to take that as a no.
    And it's correct to say that the EPA, throughout its 
history and to this day, possesses time-tested methods that 
look at the scientific data, that have peer-reviewed processes 
of other individuals who have experience and expertise in those 
areas to interpret the data?
    Dr. Orme-Zavaleta. We do rely heavily on independent expert 
peer review----
    Ms. Horn. So the EPA doesn't just take the assertions of a 
study and put it out without a peer-review process before it 
does anything with them?
    Dr. Orme-Zavaleta. Many of the studies already go through 
an independent peer-review process as part of the journal 
publication, for example, but how EPA might use that 
information may also go through additional peer review, as well 
as public comment if it's used in the decisionmaking process.
    Ms. Horn. So as a scientist, you've no doubt been through 
this peer-review process. In your personal experience, have you 
seen this as effective in assessing the validity of the data?
    Dr. Orme-Zavaleta. We rely on it heavily.
    Ms. Horn. And EPA has a number of advisory boards such as 
SAB and CASAC (Clean Air Scientific Advisory Committee) and 
other boards that evaluate the data and the science that comes 
before the EPA to evaluate or to set policies, correct?
    Dr. Orme-Zavaleta. Yes.
    Ms. Horn. And this has been used throughout the history of 
the EPA to address, as you said, public health and 
environmental issues. These are no doubt critical to our whole 
communities from our Nation's security, our soldiers, sailors, 
the water that we drink, the air that we breathe. And would you 
say that the peer-review process and analysis by these advisory 
boards are a critical component to providing necessary checks 
and balances on the validity of the data without endangering 
the personally identifiable and very important health 
information that is needed to get to the heart of these 
problems?
    Dr. Orme-Zavaleta. All right. So peer review is a core 
tenet of how we ensure good science, and the particular 
question you've raised about PII and CBI is in fact one that we 
took to our Science Advisory Board.
    Ms. Horn. So, bottom line, we do have processes in place to 
ensure that the studies that are being conducted are 
scientifically valid, and there are checks in the process by 
individuals who understand the science and the data?
    Dr. Orme-Zavaleta. Yes.
    Ms. Horn. OK. Thank you. I yield back.
    Chairwoman Johnson. Thank you very much. Mr. Lamb.
    Mr. Lamb. Thank you, Madam Chairwoman.
    Dr. Orme-Zavaleta, are you familiar with the application of 
cost-benefit analysis to an EPA rulemaking?
    Dr. Orme-Zavaleta. I am familiar with it, but I have not 
conducted that personally.
    Mr. Lamb. Administrator Wheeler emphasizes the importance 
of cost-benefit analysis as part of his administration, 
correct?
    Dr. Orme-Zavaleta. I don't know for sure.
    Mr. Lamb. On May 13, 2019 of this year he sent an agency-
wide memo in which he endorsed a sound, transparent, and 
consistent approach to evaluating benefits and costs. Do you 
remember that?
    Dr. Orme-Zavaleta. Right offhand, no.
    Mr. Lamb. OK. Was a cost-benefit analysis done for this 
proposed rule?
    Dr. Orme-Zavaleta. I'm not aware that one was done.
    Mr. Lamb. OK. Do you know that it was not done?
    Dr. Orme-Zavaleta. We could follow up with you and provide 
you that information.
    Mr. Lamb. So you don't know whether it was done or not?
    Dr. Orme-Zavaleta. No, because I was not involved in 
developing the proposed rule.
    Mr. Lamb. OK. Do you know if any cost-benefit analysis is 
planned for the future of this proposed rule or supplemental?
    Dr. Orme-Zavaleta. We will be looking at the number of 
comments that came in related to cost as we go forward in 
developing a final rule. So I think that will come into play, 
but it hasn't been part of the conversation yet.
    Mr. Lamb. Do you know if they will do a formal cost-benefit 
analysis?
    Dr. Orme-Zavaleta. We don't know yet.
    Mr. Lamb. You don't know. Will you commit that if one has 
already been done or if one is done, you will share the cost-
benefit analysis with this Committee?
    Dr. Orme-Zavaleta. I will have to follow up with you on 
that.
    Mr. Lamb. OK. Behind you, your assistant is nodding her 
head yes----
    Dr. Orme-Zavaleta. OK.
    Mr. Lamb [continuing]. So can you confirm----
    Dr. Orme-Zavaleta. No, she's not confirming. We're not 
there yet in those kinds of discussions.
    Mr. Lamb. Is there any reason why you would not share a 
cost-benefit analysis with this Committee?
    Dr. Orme-Zavaleta. If we conduct one and it's going to be 
part of the final rule, then that will be shared with everyone.
    Mr. Lamb. If you conduct one and as part of the final rule, 
you will share it with this Committee, is that correct? Yes?
    Dr. Orme-Zavaleta. Yes.
    Mr. Lamb. OK. Thank you. Have you ever heard of something 
called the Health Effects Institute (HEI)?
    Dr. Orme-Zavaleta. Yes.
    Mr. Lamb. And is it correct to say that the Health Effects 
Institute is a collaboration equally funded between the motor 
vehicle industry and the EPA for research purposes?
    Dr. Orme-Zavaleta. Yes, and in fact from EPA both Office of 
Research and Development and Office of Air and Radiation 
support the Health Effects Institute.
    Mr. Lamb. And in 2000, the Health Effects Institute did a 
re-analysis of the Harvard Six Cities study and the American 
Cancer Society study and confirmed the findings of those 
original studies. Are you aware of that?
    Dr. Orme-Zavaleta. Yes.
    Mr. Lamb. So, in other words, the auto industry paid half 
the cost, along with the EPA, of confirming that those two Six 
Cities air quality studies were accurate. Is that correct?
    Dr. Orme-Zavaleta. So both the authors of the Harvard Six 
Cities study and the author of the American Cancer Society 
study requested--given a lot of the scrutiny and questions 
placed on their studies, requested that the Health Effects 
Institute do a reanalysis, and that's how that played out.
    Mr. Lamb. And the result of that playing out was that they 
confirmed the finding of those studies, correct?
    Dr. Orme-Zavaleta. Correct, yes.
    Mr. Lamb. So, again, in other words, the auto industry 
helped to pay for the effort to confirm those two studies, 
correct?
    Dr. Orme-Zavaleta. Well, they paid for the Health Effects 
Institute. I can't say exactly what resources were used to 
support the reanalysis.
    Mr. Lamb. OK. Would you agree with Dr. Rice on our next 
panel that using the HEI to vet results like this is a 
practical and proven approach to the concerns about 
transparency specifically without compromising the health data 
privacy of study participants?
    Dr. Orme-Zavaleta. So the way the HEI approached this is 
they formed an independent panel that conducted analysis, and 
then there was a separate peer review of that analysis that was 
performed.
    Mr. Lamb. So the auto industry, through this process, was 
able to confirm the results of a study without releasing the 
health data publicly, correct?
    Dr. Orme-Zavaleta. So the auto industry supports HEI.
    Mr. Lamb. Which confirmed the results of this study without 
publicly releasing the health data, correct?
    Dr. Orme-Zavaleta. Yes.
    Mr. Lamb. Thank you. Madam Chairwoman, I yield back.
    Chairwoman Johnson. Thank you very much. That concludes our 
questioning for this panelist witness. And let me thank you, 
Dr. Orme-Zavaleta, for coming, and you're dismissed.
    Dr. Orme-Zavaleta. Thank you very much.
    Chairwoman Johnson. We will have a short recess just to let 
the second panel be set up.
    [Recess.]
    Chairwoman Johnson. Welcome back at this time. And I'd like 
to introduce our second panel of witnesses. First, we have Dr. 
Linda Birnbaum. Dr. Birnbaum served as Director of the National 
Institute of Environmental Health Sciences from 2009 to 2019, 
and she is speaking today as a private citizen.
    Dr. Mary Rice is an Assistant Professor of Medicine at 
Harvard Medical School and a Pulmonary and Critical Care 
Physician at Beth Israel Deaconess Medical Center in Boston, 
Massachusetts.
    And third, we have Dr. David Allison. Dr. Allison is the 
Dean of Indiana University's Bloomington School of Public 
Health. He has served on the Replicability in Science Committee 
at the National Academies of Sciences, Engineering, and 
Medicine.
    And Dr. Brian Nosek. Dr. Nosek is Professor of Psychology 
at the University of Virginia and the Co-Founder and Executive 
Director of the Center for Open Science in Charlottesville, 
Virginia.
    And last but not least Dr. Todd Sherer, the CEO of the 
Michael J. Fox Foundation for Parkinson's Research.
    As with our first panel, you each will have 5 minutes for 
your spoken testimony. Your written testimony will be included 
in the record for the hearing. And when all of you have 
completed your spoken testimony, we will begin the round of 
questions. Each Member will have 5 minutes to question the 
panel.
    We will begin now with Dr. Linda Birnbaum.

               TESTIMONY OF DR. LINDA S. BIRNBAUM,

             FORMER DIRECTOR, NATIONAL INSTITUTE OF

            ENVIRONMENTAL HEALTH SCIENCES, 2009-2019

    Dr. Birnbaum. Good morning, Chairwoman Johnson, Ranking 
Member Lucas, and distinguished Members of the Committee. I'm 
Linda Birnbaum, recently retired after 40 years of Federal 
service. I was Director of NIH's (National Institute of 
Health's) National Institute of Environmental Health Sciences 
(NIEHS) and with HHS' (Department of Health and Human Services) 
National Toxicology Program for the past 10 years. Prior to 
that, I spent 19 years at EPA for most of it directing the 
Agency's largest health research division. I've conducted 
scientific research to better understand how the environment 
impacts our health and have published over 800 peer-reviewed 
papers, book chapters, and reports.
    I'm a member of the National Academy of Medicine, the 
recipient of the North Carolina Governor's Award for Science, 
the former President of the Society of Toxicology, the Vice 
President of the International Union of Toxicology, Chair of 
the Toxicology Division of the American Society of Pharmacology 
and Experimental Therapeutics, and the recipient of multiple 
honorary degrees and awards.
    I've always been involved in the conduct of research, much 
of which has been used in making policy decisions. My work and 
that which I have overseen has involved basic biomedical 
research, toxicology, and public health. I've never been a 
regulator myself.
    My comments today are those of a private citizen and do not 
reflect the views of NIEHS, NIH, or HHS.
    I want to focus on three basic issues. The first is the 
core values of scientific studies, which involve people. 
Because it is unethical to intentionally expose people to 
chemicals of concern, observational human studies compare 
populations who have different exposures. People provide 
personal information such as medical information, as well as 
behaviors in confidence that their own data will not be openly 
shared.
    Human studies require confidentiality to be conducted. It 
is unethical to reveal individual human data. In many 
epidemiology studies, scientists and subjects work closely 
together in design, conduct, interpretation, and communication 
of the findings. Thus, the second point is that the impact of 
EPA's proposed transparency rule will not only make it more 
difficult for human studies to be conducted ethically but in 
many cases will make it impossible to use any information 
collected not only prospectively but looking back at the vast 
treasure trove of existing investigations.
    The third point involves EPA's mandate to use the best 
available science to protect the environment and public health. 
Scientific knowledge is constantly evolving. While a given 
experiment may answer one question, it invariably raises 
others. There is always some uncertainty in science, but that 
does not mean that decisions cannot be made, which is why it is 
so important to use all the data.
    While I am a toxicologist, that does not mean I prefer 
using animal data when data from people exists. Nature is 
inherently conservative, and studies in various animal models 
can inform us about the potential for human risk. We can 
investigate, observe the effects mechanistically in animal and 
cell culture models, and then ask whether the same mechanisms 
exist in humans. Such approaches all provide biological 
plausibility to human observational studies.
    When we have several epidemiology studies in different 
populations conducted by various investigators and achieve the 
same results and they're supporting animal and mechanistic 
evidence, why would we think that we can't believe the 
findings? Why would we want to rely solely on 20th-century 
methodologies in the 21st century? Good laboratory practice 
only assures that we know what was done, not that the right 
question was asked.
    The same can be said of some guideline studies, which may 
be inappropriate when you're looking for effects of 
pharmaceuticals in an individual rather than effects of 
environmental exposures on a population. Small effects may not 
be measurable in an individual but may have large impacts on a 
population. For example, developmental exposure to lead results 
in the loss of several IQ points in a population, which has 
significant economic and societal costs, but you can't know 
whether each of us would be a little smarter if we hadn't been 
exposed to lead.
    Today, we have systematic review of the lead data which 
confirm that there is no safe level for lead. In fact, the more 
we look at population data, there is no threshold for many 
exposures, including arsenic, mercury, and air pollution. 
Thresholds are often a function of analytical methodology. Why 
would EPA want to enshrine threshold approaches in regulation?
    EPA's proposed transparency rule in fact will block the use 
of the best science. It will prevent EPA from using the best 
available science in making policy. In fact, it will 
practically lead to the elimination of science from 
decisionmaking. EPA's current proposal would silence science 
and block its ability to meet its mission of protecting human 
health and the environment.
    Thank you, and I welcome your questions.
    [The prepared statement of Dr. Birnbaum follows:]
    
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    Chairwoman Johnson. Thank you very much. Dr. Rice.

                 TESTIMONY OF DR. MARY B. RICE,

                ASSISTANT PROFESSOR OF MEDICINE,

           HARVARD MEDICAL SCHOOL, AND PULMONARY AND

                    CRITICAL CARE PHYSICIAN,

              BETH ISRAEL DEACONESS MEDICAL CENTER

    Dr. Rice. Madam Chairwoman, Ranking Member, and Members of 
the Science Committee, thank you for the opportunity to speak 
today. I'm a Pulmonary and Critical Care Physician at Beth 
Israel Deaconess Medical Center at Harvard Med School where I 
treat patients with lung disease and study the effects of air 
pollution on lung health.
    I am speaking on behalf of the American Thoracic Society 
(ATS). We are a 16,000-member medical professional organization 
dedicated to the prevention of lung disease, and we treat 
patients with illnesses such as asthma, COPD (chronic 
obstructive pulmonary disease), or lung cancer that are caused 
or worsened by air pollution. We have serious concerns about 
the EPA's proposal and what it means for our patients and the 
health of Americans, especially children and the elderly, who 
are especially susceptible to pollution.
    Our major objection to this proposal is that by excluding 
studies whose underlying data cannot be shared with the public, 
it would effectively block EPA from considering critical 
studies that involve real people living in the real world and 
exposed to day-to-day levels of pollution. These epidemiology 
studies provide the most relevant information to protect the 
health of the American public. They have repeatedly shown that 
pollution is linked to premature death in older adults due to 
heart attacks and respiratory causes, to worse lung function 
and asthma attacks among kids and adults.
    There are multiple mechanisms for data-sharing and 
resolution of controversy in research, but this proposal is not 
about improving transparency. It is a strategy to block sound 
science. I'll explain how this proposal introduces a process 
barrier.
    Before a health study can begin, investigators must 
complete a rigorous review by an institutional review board to 
ensure that the risks of participating in the study are as low 
as possible, including risks to privacy. Study participants 
sign a consent form that details how their private data will be 
protected. Researchers cannot share publicly data about 
people's medical problems, hospitalizations, or deaths or the 
addresses of their homes and schools. So under this rule, EPA 
would disregard such studies in its rulemaking because the 
demand for public data sharing cannot be met.
    Ignoring medical research in regulatory decisionmaking is 
the opposite of progress, and it's not in the interest of human 
health. As a doctor, I would do my patients a disservice if I 
ignored a huge chunk of the scientific literature in making my 
medical decisions. And the same would be true for EPA if it 
ignored evidence in making decisions about toxins in our 
environment.
    It's naive to argue that de-identification will fully 
protect the privacy of study participants in today's era of big 
data. For example, a recent study in California took the HIPAA 
(Health Insurance Portability and Accountability Act)-compliant 
de-identified data from an air pollution study and, using 
publicly available databases and programs, the investigators 
re-identified one in four study participants. Now, imagine the 
long-term consequences of leaking private health and address 
information as a result of this proposal. Would you be willing 
to enroll yourself or your child in a study about toxins in the 
water, air, or food if you knew EPA would take your data and 
share it with the world?
    Second, I want to emphasize that this process barrier is a 
familiar and sneaky strategy to discredit science that was 
pushed by big tobacco in the 1990s. As mentioned earlier, 
there's an internal memo that I've included with my testimony 
from 1996 by tobacco lawyer Chris Horner that lays out a 
detailed strategy for how the tobacco industry can discredit 
scientific findings that it doesn't like.
    Mr. Horner advised big tobacco to focus on process as 
opposed to scientific substance because attacking the substance 
of the science that secondhand smoke is bad for health would be 
a public relations nightmare. He advised big tobacco to lobby 
for the construction of, quote, ``explicit procedural hurdles 
the EPA must follow in issuing scientific reports.'' The memo 
used the same terms of, quote, ``transparency'' and, quote, 
``sound science'' that the EPA is now using in its proposal.
    The American Thoracic Society is not fooled. This proposal 
is not about transparency; it's about discrediting or ignoring 
science about the harmful effects of toxic exposures to our 
kids and all adults.
    And one final point, this proposal gives broad discretion 
to the EPA Administrator to, quote, ``exempt significant 
regulatory decisions on a case-by-case basis.'' And the ATS is 
concerned that this grants excessive authority to the 
Administrator, without accountability to the public to cherry-
pick studies that support political objectives and ignores 
studies, no matter how robust, that have inconvenient results. 
This flies in the face of any transparent scientific process.
    Our patients with lung disease and all Americans depend on 
the EPA to make well-informed decisions based on the best 
available evidence to set environmental standards that protect 
their health.
    On behalf of the ATS, I implore this Committee and Congress 
to prevent EPA from adopting process proposals that block peer-
reviewed research from being considered in its rulemaking, and 
I look forward to your questions. Thank you.
    [The prepared statement of Dr. Rice follows:]
    
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      Ms. Bonamici [presiding]. Thank you for your testimony.
    I now recognize Dr. Allison for 5 minutes for your 
testimony.

                 TESTIMONY OF DR. DAVID ALLISON,

                 DEAN, SCHOOL OF PUBLIC HEALTH,

          INDIANA UNIVERSITY-BLOOMINGTON, AND MEMBER,

        ``REPRODUCIBILITY AND REPLICABILITY IN SCIENCE''

         COMMITTEE, THE NATIONAL ACADEMIES OF SCIENCES,

                   ENGINEERING, AND MEDICINE

    Dr. Allison. OK. Good morning, Ms. Bonamici, Ranking Member 
Lucas, and Members of the Committee. Thank you for the 
opportunity to speak with you today. My name is David Allison, 
and I have the privilege of serving as the Dean of the School 
of Public Health at Indiana University Bloomington, although 
today I am not speaking on behalf of Indiana University but as 
a member of the National Academies' Committee on 
Reproducibility and Replicability in Science. I've dedicated my 
career to the pursuit of knowledge through rigorous science and 
its truthful communication.
    My written testimony provides background on the National 
Academies' Committee, a copy of the executive summary of the 
committee's report, and an expanded version of my remarks here.
    Science is a method to discover and share knowledge about 
the world. In science, three things are vital: The data, the 
methods used to collect the data which give them their 
probative value, and the logic connecting the data and methods 
to conclusions. These are the substrates of science.
    The data, methods, and logic used to inform conclusions 
need to be thoroughly and transparently described so that 
others may understand what was done and thereby judge the 
probative value of the data for the conclusions. As we all 
heard from our middle school mathematics teachers, show all 
your work. That is, it is not enough to provide an answer. One 
must show us how one got the answer. Transparency has value.
    I will now address the questions posed by you and conclude 
my testimony with my own perspectives on the EPA proposed rule. 
The first question posed to me was what is the definition of 
reproducibility? The Academies' study defined reproducibility 
as obtaining consistent results using the same input data, 
computational steps, methods and codes, and conditions of 
analysis.
    Another important concept is scientific rigor. Rigor can be 
defined as the diligent application of scientific procedures 
that, based on principles and theories of science, would be 
expected in probability to offer successively ever-better 
approximations to the truth.
    The remaining questions on my invitation to testify focused 
on the risks of both a strict interpretation of the proposed 
EPA rule and the establishment of reproducibility standard 
within its regulatory process. And they ask how rigor and 
reproducibility are related.
    Were reproducibility to become the sole and essential 
criteria for inclusion of data, some sound research would 
likely be excluded from EPA environmental and public health 
regulations. Reproducibility by itself is neither necessary nor 
sufficient for determining the validity of a study. In general, 
a rule that strongly encourages and incentivizes making science 
transparent and reproducible would be good. In contrast, a rule 
which made transparency and reproducibility jointly necessary 
or jointly sufficient for the admissibility of a study could 
result in the exclusion of high-quality studies that, for 
legitimate reasons, cannot be made fully transparent and 
reproducible.
    At the other extreme, studies may be transparent and 
reproducible but contain flaws leading to incorrect 
conclusions. Transparency contributes to rigor, but additional 
aspects of rigor are vitally important, including 
appropriateness of study design, sampling procedures, 
measurements, and statistical analyses.
    The 2018 proposed EPA rule allows for exceptions. What is 
unclear is how exceptions will be adjudicated and whether the 
adjudication process will lead to the exclusion of rigorous 
studies, potential bias in terms of which studies and data sets 
are used in rulemaking, and ultimately diminish public trust.
    Finally, it is not obvious that a rule addressing the 
admissibility of studies in rulemaking would serve EPA's goals 
of promoting transparency and rigor in science better than 
would a statement of principles on the valuing and weighting of 
evidence, especially with so many likely and necessary 
exceptions built into the rule.
    In summation, the National Academies' Study Committee and 
I, as an individual scientist, are strong proponents of 
reproducibility and replicability of transparency and science 
and, more importantly, of the utmost rigor in the execution of 
and the unvarnished truthful communication of scientific 
research. To the extent that EPA can enact procedures that 
promote these practices, that is all to the good. Yet there 
must be flexibility to allow for research lacking complete 
transparency or reproducibility but otherwise shown to be 
rigorous to inform rulemaking.
    Just as other scientific communities and government 
regulatory bodies relying on scientific information must do, I 
advocate that we consider all relevant scientific information, 
while providing the most weight to the best information. As 
scientists drawing conclusions about whether propositions have 
been demonstrated to be true, we might withhold a conclusion 
unless research meeting some specified condition is available. 
But as a society engaged in prudent decisionmaking, we must 
make our decisions on the best information available. Thank 
you.
    [The prepared statement of Dr. Allison follows:]
    
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    Ms. Bonamici. Thank you for your testimony.
    I now recognize Dr. Nosek for 5 minutes for your testimony.

                  TESTIMONY OF DR. BRIAN NOSEK,

               CO-FOUNDER AND EXECUTIVE DIRECTOR,

                    CENTER FOR OPEN SCIENCE

    Dr. Nosek. Chairwoman Johnson, Ranking Member Lucas, and 
Members of the Committee, thank you for this opportunity to 
discuss the role of transparency and reproducibility for 
maximizing the return on research investments.
    In 2013 Jeff Spies and I launched the Center for Open 
Science or COS out of my lab at the University of Virginia as a 
nonprofit technology and culture-change organization. COS has a 
mission to increase transparency, integrity, and 
reproducibility of research. To advance that mission, we 
maintain the free and open-source, open-science framework, a 
cloud-based collaborative management service used by more than 
180,000 researchers to improve the rigor and transparency of 
their research.
    COS is also working to change the incentives landscape in 
academic science with a policy framework that promotes 
transparency called the TOP (Transparency and Openness 
Promotion) Guidelines and initiatives that promote the 
visibility of open practices and shift publication criteria 
toward rewarding asking important questions and using rigorous 
methodologies rather than demanding exciting results.
    Finally, COS conducts meta-science, research on the 
research process, to identify inefficiencies in discovery and 
to evaluate whether the intervention is to reduce those 
inefficiencies are effective. Lack of transparency creates 
friction in the pace of discovery and reduces the return on 
investment of research dollars. We can increase the returns by 
promoting greater transparency of a variety of research 
outputs.
    Ideally, you would have transparency of my research plans, 
what I thought I was doing in advance, so that you can compare 
the studies that ended up published with the studies that I did 
that were not published and what my plans were to do at the 
outset versus what I discovered after the fact. Transparency of 
my materials would allow others to examine how it is I got to 
the conclusions that I got to and then re-use those materials 
for other purposes. Transparency of my data will make it easier 
for others to replicate or extend or evaluate the rigor of the 
conclusions that I draw, and transparency of the outcomes makes 
sure that all of our research investments are available in 
terms of what we learned from these investments in science.
    There is a maturing infrastructure of tools and services 
that make it possible for researchers to do these behaviors. 
There's also a growing awareness and shifting norms within the 
research community about the importance of transparency. For 
example, the TOP Guidelines policy framework has been adopted 
by more than 1,000 scientific journals for authors and by some 
funders for their grantees. There is more work to do, but your 
continuing support for these efforts could have salutary 
effects on the research culture.
    Ultimately, COS believes that the biggest opportunity for 
reducing friction in the research process is setting the 
default to open, open plans, open materials, open data, and 
open outcomes. Flipping the default from closed to open will 
foster decisionmaking frameworks for the exceptions when other 
interests outweigh the goal of transparency.
    Two common occasions in which competing principles can 
dominate are protecting intellectual property and protecting 
participant confidentiality for sensitive human subjects 
research. Sensible policies for managing these competing 
interests will facilitate the culture shift that's already 
underway.
    There are also important considerations for how best to use 
scientific evidence in policymaking. The EPA rule that prompted 
this hearing had the positive qualities of identifying 
transparency and reproducibility but had the negative quality 
of suggesting that evidence failing to meet those principles 
should not be used. It is important to use the best available 
evidence for rulemaking. There will always be occasions in 
which the best available evidence is not fully transparent or 
has unknown reproducibility, and there are many potential 
solutions for assuring credibility of findings when underlying 
data cannot be fully transparent.
    There are many factors that affect the quality of research, 
the certainty of its conclusions, and its generalizability to 
the policy context. The goal should not be transparency or 
bust. The goal should be explicitly representing the 
uncertainty of evidence to help you as policymakers make better 
decisions. There are in fact federally funded research efforts 
underway to assist with this if you'd like to discuss that 
during Q&A.
    Thank you for your continuing support of science and for 
the opportunity to speak with you today.
    [The prepared statement of Dr. Nosek follows:]
    
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    Ms. Bonamici. Thank you for your testimony.
    I now recognize Dr. Sherer for 5 minutes for your 
testimony.

                  TESTIMONY OF DR. TODD SHERER,

               CEO, THE MICHAEL J. FOX FOUNDATION

                    FOR PARKINSON'S RESEARCH

    Dr. Sherer. Thank you, Madam Chairwoman, Ranking Member 
Lucas, my Representative Congresswoman Sherrill, and the other 
esteemed Members of the Committee. Thank you again for the 
opportunity to testify today.
    My name is Todd Sherer, and I'm a Ph.D.-trained 
neuroscientist and CEO of the Michael J. Fox Foundation for 
Parkinson's Research. Parkinson's disease is estimated to 
affect 1 million people in the United States, severely 
impacting quality-of-life for patients and their loved ones. 
This disease costs the U.S. Government and American families 
$52 billion each year, $25 billion of which comes from Medicare 
and Social Security. Our foundation strives to partner 
effectively with the government to leverage Federal research 
investments and help get more good ideas into clinical testing.
    It would be impossible to overstate the importance of 
increasing the flow of patients into these clinical studies. 
Encouraging research participation by more patients and 
families is a major focus for us. Since we were founded, we 
have funded more than $900 million in research to accelerate 
progress toward a cure. As Federal research funders do more, we 
can do more, and together we can accelerate real results to 
those living with this disease.
    Before I joined the foundation, I was a bench 
neuroscientist focused on the underlying causes of Parkinson's 
disease. Parkinson's is a neurodegenerative disorder. Symptoms 
include the more recognized movement aspects such as tremor and 
slowness but also memory and thinking problems, mood disorders, 
and sleep issues. There are no treatments to slow or stop the 
progression of the disease.
    Because the symptoms can develop slowly, people in the 
early stages of Parkinson's still go to work, engage with 
family and friends, and remain leaders in their communities. 
These individuals also want to participate in clinical studies 
toward better treatments and a cure. They have every right to 
keep their diagnosis private and still participate in research.
    But the EPA's proposed rule puts these individuals at great 
risk of having their Parkinson's diagnosis exposed. Such 
exposure could result in unfair job loss snowballing into a 
loss of income, insurance, and other life-altering 
consequences. It is vital that we protect patients' right to 
privacy.
    I do want to be clear, the Michael J. Fox Foundation 
believes that transparency is critical in research. Open data-
sharing among the scientific community is a core value of our 
foundation to speed discovery and replication and to deepen the 
public's trust in findings. With the consent of its 1,500 
patient and control volunteers, our Parkinson's progression 
markers initiative makes all de-identified data available to 
the research community. Scientists around the world have 
downloaded this data nearly 5 million times and used it in more 
than 150 peer-reviewed published papers with the goal of 
improving the diagnosis and treatment of Parkinson's.
    Similarly, we encourage the thousands of researchers who've 
received grants from us to make data available based on the 
nature of the study and the feasibility of de-identification. 
Stripping data of personally identifiable information is 
critical in protecting privacy. There must be a balance between 
research transparency and protecting patient confidentiality. 
Major scientific journals follow a similar practice and only 
require data to made confidentially available to other 
researchers to reproduce or extend analyses.
    If the proposed rule were enacted, there are thousands of 
studies that would be excluded from the EPA's evaluation when 
it comes to determining standards, policies, and programs that 
keep us all safe. For example, epidemiological and population-
based studies form the bedrock of knowledge for determining the 
environment's impact on human health. Data collected through 
these types of studies cannot always be adequately deidentified 
and therefore should be protected and not publicly shared.
    Under the EPA's proposed rule, findings from these studies 
could not be used by the Agency as it sets national 
environmental standards, but census data and epidemiological 
studies are critical to understanding the causes of Parkinson's 
disease. We believe most if not all Parkinson's cases are due 
to a combination of genetic and environmental factors.
    I want to share a story, with his permission, from Kevin 
Kwok of California. Kevin is 58 years old and was diagnosed 
with Parkinson's when he was 46. He spent his college summers 
hauling toxic waste drums at a well-known global chemical 
company and cleaning the insides of chemical reactors. Even 
with protective outerwear and following OSHA (Occupational 
Safety and Health Administration) safety guidelines, he had 
direct contact with chemical reagents every day for months. 
While we can't say with certainty that the job had a direct 
impact on Kevin's diagnosis, with more research, we may know in 
the future how these exposures contributed to his disease.
    Kevin is an avid research participant and hopes that his 
contributions can inform not only the science of Parkinson's 
but also the legislation that impacts people living with the 
disease who are at risk. For example, in addition to stories 
like Kevin's, there are dozens of studies linking Parkinson's 
disease to pesticide exposure, many of which would be not 
admissible under this proposed rule.
    The proposed rule will force EPA to make decisions based on 
less information, which compromises its core mission. Please 
ensure the EPA continues to balance the need for scientific 
integrity and transparency with its duty to protect the health 
of Americans. Thank you for the opportunity.
    [The prepared statement of Dr. Sherer follows:]
    
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    Ms. Bonamici. Thank you for your testimony.
    At this point we will begin our first round of questions, 
and I recognize myself for 5 minutes for my questions.
    It's an honor to hear from such a distinguished panel of 
scientists. And this rule has inspired a lot of attention in 
the scientific community. And I'd like each panelist to answer 
very briefly, basically yes or no, do you support the 
``Strengthening Transparency and Regulatory Science'' rule as 
written?
    Dr. Birnbaum. No.
    Dr. Rice. No.
    Dr. Allison. More information and clarification is needed.
    Dr. Nosek. Not as written.
    Dr. Sherer. No.
    Ms. Bonamici. Thank you very much. The EPA's proposed rule, 
which we've discussed in this Committee, the essence of it many 
times, undermines scientific integrity, jeopardizes bedrock 
public health and environmental standards, and endangers the 
EPA's ability to protect the American people. It's particularly 
troubling that the proposed rule appears to be inconsistent 
with the EPA's statutory obligation to use the best available 
science, as required in the Toxic Substances Control Act, the 
Safe Drinking Water Act, the Clean Water Act. And if finalized 
in its current form, the proposed rule would preclude the use 
of a range of scientific research that has long been used to 
safeguard the public.
    There's also tremendous uncertainty about how this proposed 
rule and supplemental would be applied and to what it would be 
applied, and regardless of how that question is ultimately 
answered, we know that the rule will severely undermine public 
health and environmental protections.
    I want to start with Dr. Birnbaum. In your testimony, you 
discuss the evolving nature of science and the importance of 
using all data. If finalized in its current form, how would 
application of the proposed rule affect the scientific 
foundation of the EPA's regulatory decisionmaking?
    Dr. Birnbaum. So all the available data would mean all the 
epidemiology studies if there are any clinical studies--and 
occasionally with air pollution work we've had some clinical 
studies done. It would include animal studies. It would include 
mechanistic studies. And the requirement for public 
availability of all the underlying human data would preclude 
the use of most of the epidemiological and clinical studies, 
which would mean that we would be forced to make our decisions 
based upon animal data only.
    Now, the animal data, the question is how much of that will 
be freely available as well because if some of the data is, 
say, conducted using chemicals which may have CBI information, 
that would not be able to be shared. So you lead to 
constriction of the databases that you can use to make your 
decision.
    Ms. Bonamici. Thank you very much.
    Dr. Allison, the National Academies have issued numerous 
reports to advise the EPA on opportunities to improve 
transparency on the collection and analysis of data. And I 
think everyone here supports transparency. Most recently, these 
reports have included reproducibility and replicability in 
science, open science by design, and fostering integrity in 
research. Does the proposed rule respond to impediments that 
reproducibility, as outlined in the Academies' Reproducibility 
and Replicability in Science report?
    Dr. Allison. The proposed rule has some provisions in it 
that respond to some of the issues in the reproducibility and 
replicability report, but I am not clear that it would take 
into account all of the comments on it. Clearly, more 
information in the proposed rule would be necessary to 
understand how it would be implemented and whether it would 
successfully accommodate the issues.
    Ms. Bonamici. Thank you. And I mentioned earlier today that 
I'm sending a letter requesting that the National Academies of 
Sciences, as an authoritative and independent nonpartisan 
scientific organization, work with the EPA to review the 
proposed rule. Last year, the presidents of the National 
Academies submitted public comments for the proposed rule and 
warned that it could pose a threat to the credibility of 
regulatory science at the EPA. The Academies urged the EPA to 
seek objective expert guidance on the rule and offered their 
own assistance in reviewing it.
    So as a member of the National Academy of Medicine--is that 
Dr. Rice? Dr. Birnbaum. As a member of the National Academy of 
Medicine, do you agree that the uncertainties in the proposed 
rule require the independent expert advice of the National 
Academies?
    Dr. Birnbaum. I think it's always useful to get the 
Academies' advice, but I think there is enough information out 
there that some of the problems with the rule require it to be 
redrafted. It would be good if they saw sought outside advice 
in doing that.
    Ms. Bonamici. Right. And, Dr. Allison, you as well I 
understand are a member of National Academy of Medicine. Do you 
agree that the uncertainties in the proposed rule require 
independent expert advice of the National Academies?
    Dr. Allison. The National Academies were established by the 
U.S. Government for the purpose of providing advice to other 
organizations on scientific matters and are pleased to do so 
when called upon.
    Ms. Bonamici. Thank you very much. And I see my time is 
expired. I just want to close with an appreciation for Dr. 
Sherer. As someone with a family member with Parkinson's, I 
appreciate your being here, but I also understand the 
sensitivity of sometimes people do not want to disclose their 
diagnosis but they still want to get the help and participate 
in studies, so your points are well taken.
    And I yield back, and I now recognize Mr. Lucas for 5 
minutes for your questions.
    Mr. Lucas. Thank you, Madam Chair.
    Dr. Nosek, in your prepared testimony you stated that the 
EPA rule had the positive qualities of identifying the 
importance of transparency and reproducibility of research but 
had the negative quality of suggesting that evidence failing to 
meet these principles should not be used in policymaking. I 
appreciate your effort to provide constructive input on this 
policy, as well as your work to better institutionalize 
transparency in the research community. Given your expertise, 
can you provide additional insights into what you would like to 
see in any science transparency policy both at the EPA and 
governmentwide to make it more practical for all policymakers 
and researchers?
    Dr. Nosek. Yes. Thank you for that question. So as I noted 
in the statements, a general hope for policymaking is that 
openness is the default assumption, is that part of the value 
and opportunity that we have, given the modern ability to share 
information very widely, is to provide tools and resources and 
services to make much more of the research process itself, not 
just the end conclusions, more available to all.
    In terms of implementation issues related to that policy, 
to the extent that there could be provisions that address the 
issues that have been raised by the whole panel on managing 
privacy, this would be a significant advantage for the 
applicability of the rule to maximize the availability and use 
of research evidence. So, for example, data enclaves that 
manage the preservation of data but still the privacy of that 
data for independent others to confirm its validity is a means 
of potentially promoting the credibility and overall 
reproducibility of findings while simultaneously managing that 
with privacy concerns.
    Mr. Lucas. Your research involves developing technology 
solutions to help researchers incorporate transparent 
mechanisms as they conduct their research. One example is the 
open science framework (OSF), an online data management tool 
that allows scientists to store their data privately as they 
conduct their research but then allows them to easily make the 
entire project publicly accessible once their work is 
completed. The OSF also allows individual researchers to set 
the parameters of disclosing data, establishing tiered and more 
limited access to data that may require additional controls 
such as personal, sensitive information. How could a Federal 
agency use OSF or similar technology to improve data 
transparency?
    Dr. Nosek. So some opportunities for using OSF and the many 
other tools and services that support similar aims would be 
building into grant requirements what the provisions are for 
the preservation of the research planning, the materials, the 
data, and the outcomes that were produced from that work and 
under what conditions that data must be preserved over a period 
of time and which parts of it can be made publicly accessible 
to the maximum extent possible.
    So many agencies that provide funding for Federal research 
already have been making advances for data management plans 
being an important part of the proposal process for grants. NIH 
just released some new plans for their data management 
planning, for example. Continuing to support those efforts 
would be very useful.
    Mr. Lucas. So along that line, a similar-tiered access 
approach could be useful in ensuring appropriate data 
protections for all Federal research?
    Dr. Nosek. Yes.
    Mr. Lucas. With that, Mr. Chairman, I yield back.
    Mr. Casten [presiding]. Mr. Tonko, you are recognized for 5 
minutes.
    Mr. Tonko. Thank you, Mr. Chair.
    I have here a letter, Mr. Chairman, that was sent to the 
Committee by esteemed organizations, including the 
Environmental Defense Fund, the Union of Concerned Scientists, 
Earth Justice, the Natural Resources Defense Council, the 
Environmental Protection Network, and the Clean Air Task Force, 
all requesting that this rule not move forward.
    The letter states that the rule has been criticized by, 
quote, ``leading scientific organizations and public health 
organizations with the editors of the Nation's leading 
scientific journals; Presidents of the National Academies of 
Sciences, Engineering, and Medicine; the President of Harvard 
University; nearly 100 leading Harvard scientists and medical 
experts; EPA's own Science Advisory Board, and other scientific 
experts have all voiced concerns about the proposed rule.''
    The letter concludes, and I quote, ``For the sake of the 
air and water, the EPA has been tasked with protecting and the 
millions of human lives that rely on these resources, EPA must 
not finalize this proposal,'' close quote.
    I share these concerns and move to enter the letter into 
the record.
    Mr. Casten. Without objection.
    Mr. Tonko. Thank you. In terms of public health, what 
consequences should we be most worried about if this rule moves 
forward, to anyone on the panel? Yes. Doctor?
    Dr. Rice. Thank you for that question. Let me give an 
example. So the EPA right now is looking at the National 
Ambient Air Quality Standard for particulate matter, and as 
part of that review, they just released their policy 
assessment. They looked at hundreds of studies about the health 
effects of particulate matter. And where the data are 
particularly robust is that long-term exposure of particulate 
matter is associated with premature mortality. There are many 
studies that have shown that. So just for this particular 
policy assessment, the EPA focused on 21 studies looking at 
particulate matter and total mortality, 14 on premature 
cardiovascular death, 10 on lung cancer, 7 on respiratory 
premature death.
    If this proposed rule were implemented now, the EPA would 
not be able to use those studies in deciding what level of 
particulate matter is safe because the studies could not meet 
the requirements for public data release. And so the EPA would 
be setting a health standard that affects the health of the 
entire country, all of us, on exposure that is clearly 
associated with mortality and just ignoring that science. And 
we are very concerned about what the long-term ramifications 
would be of setting standards without looking at the science.
    Mr. Tonko. Thank you, Dr. Rice.
    Anyone else on the panel? Yes.
    Dr. Allison. I think it's really the health of science 
that's the key question here, and I think that anything which 
serves to restrict access to useful information on the basis of 
a simplistic notion of looking at one indicator of the value of 
research is unwise and undermines the health of science and 
rationality in general. We need to consider the many aspects 
that provide science its probative value, not only 
reproducibility and transparency.
    Mr. Tonko. So that being said, to the panel again, the 
entire panel, how would this rule then affect the health of 
future generations?
    Dr. Birnbaum. So many of the exposures that we experience 
have effects on susceptible populations. And one of the most 
susceptible populations are the unborn and young children. And 
the effects that occur developmentally, the exposures that 
occur developmentally not only may have immediate effects but 
can have effects that will last the rest of your life. So the 
effects here could affect an entire generation.
    Mr. Tonko. Thank you, Dr. Birnbaum.
    Anyone else that wants to take a stab at answering how it 
would affect future generations? Dr. Rice?
    Dr. Rice. Yes, I, too, would echo that my greatest concern 
is our children, my own children. I have three kids. I have one 
of them who has respiratory problems. It is clear that--and I'm 
an air pollution scientist, so that's a pollutant I focus on. 
But air pollution exposure makes kids sicker and increases 
their----
    Mr. Tonko. In what ways? Addressing what types of diseases?
    Dr. Rice. So asthma attacks----
    Mr. Tonko. OK.
    Dr. Rice [continuing]. So children who have asthma are more 
likely to end up in the hospital or to use medications for 
their asthma. Studies in California and across the country have 
shown that exposure to pollution makes kids' lung function 
trajectory slow down, and they don't attain the level--the same 
level of peak lung function in adulthood that they might have 
if they were exposed to lower levels of pollution. So these are 
critical windows of exposure. And so exposure to our children 
today matters for the health that they attain for the rest of 
their lives.
    Mr. Tonko. So if this rule isn't supported by public health 
groups or scientific societies, then it forces us to ask why 
did the Administration go down this path?
    Dr. Rice. I can't answer that question, but in my oral 
testimony and my written testimony I want to draw attention to 
the fact that there's a history here and that there's a long 
precedent of using the terms transparency and reproducibility 
in science as a barrier for using science that's inconvenient.
    So let me give just one example. Back in the 1990s R.J. 
Reynolds used a law in Georgia to get the raw data from a study 
that a pediatrician that looking at Joe Camel, the cartoon 
character, and how it appealed to kids, and they recognized 
that he was associated with tobacco smoking more than they knew 
that Mickey Mouse was associated with Disney. And that wasn't 
the only study showing that. The Journal of the American 
Medical Association released multiple studies showing that that 
kind of marketing appealed to kids. So it wasn't really that 
controversial. But then when they got the raw data, they 
attacked the scientists, and they attacked the conclusions that 
he drew. And I worry that those are some of the motivations 
behind this effort.
    Mr. Tonko. Yes, it's tragic. With that, I yield back, Mr. 
Chair.
    Mr. Casten. Mr. Baird, you're recognized for 5 minutes.
    Mr. Baird. Thank you, Mr. Chair.
    And, Ranking Member Lucas, I appreciate the opportunity to 
ask questions. I really appreciate the opportunity to have 
comments from such a distinguished group of witnesses. That's 
very helpful and insightful for our Committee and the work that 
we're trying to do.
    I only have a certain amount of time, so, Dr. Allison, 
you're the one that I'm going to ask a couple of questions of. 
First off, though, I just wonder if you're aware that if you'd 
have just gone 2 more hours north when you came to Indiana from 
Alabama you'd have been at Purdue University.
    You know, in your testimony and all the work that you've 
done, what, over 600 scientific publications, you've edited 
five books, you serve as a member of the Committee on 
Reproducibility and Replicability from the National Academy of 
Sciences, so I think it's very appropriate to have you here to 
talk about the things that we're interested in today.
    And so my first question is that in your testimony you 
mentioned that perhaps a thorough statement of raw principles 
like what constitutes good scientific evidence and how to 
effectively weigh and evaluate evidence for drawing conclusions 
could be more useful than a single rulemaking transparency. 
Could you elaborate on that?
    Dr. Allison. Certainly. Let me say that these are my own 
opinions are not necessarily those of the committee that I was 
here to represent today since the committee didn't address the 
EPA rule per se.
    But it seems to me that EPA, to construct a simplistic rule 
that says information will be available or usable only if it's 
reproducible and transparent puts too much weight on one 
factor. It may allow things in that shouldn't come in, and it 
may exclude things that shouldn't be excluded, whereas there 
are other factors that need to be involved. It becomes 
reasonable only to the extent that exceptions are allowed. But 
those exceptions will likely be extensive and frequently 
necessary. Questions have already been raised about exactly how 
would those exceptions be made, and would the process of making 
those exceptions foster trust or distrust or optimal 
approaches?
    Better yet it seems to me would be to say multiple factors 
are important to weigh, including but not limited to 
reproducibility and transparency, replicability, 
generalizability of findings, and importantly, overall research 
rigor. This can be assessed on a case-by-case basis so that the 
overall evidence can be weighed, all evidence can be 
considered, but then ultimately decisions are based upon the 
weight of the evidence. This is the typical practice in much of 
science, as I wrote extensively in my written remarks about 
this, and is a practice generally used by other organizations, 
for example, like FDA (Food and Drug Administration).
    Mr. Baird. I found it especially interesting you mentioned 
that scientific research, you know, involves data and methods 
and logic in how you got there, but the application of rigor in 
the methods, I found that extremely useful and extremely 
relevant to making sound scientific decisions. So any further 
thoughts on that issue on rigor?
    Dr. Allison. Certainly. We know that a great deal of 
science varies tremendously in the degree of rigor. Some 
studies have stronger value than others in helping us determine 
the truth of propositions. We can only evaluate the strength of 
those studies to the extent that we really know what was done. 
So knowing what was done is very important, and that's partly 
where transparency comes in.
    So transparency is vital. We do want to promote it in all 
of science. As Dr. Nosek said, we are, as an entire scientific 
community, working on this, taking ever greater steps to make 
more and more science transparent. But, as Dr. Rice and others 
have pointed out, there will always be certain aspects of 
science that are not fully transparent for any number of 
reasons. These could include protection of patient privacy, 
fulfillment of the contract of informed consent, simple loss of 
information, and we should not make a dicto simpliciter out of 
the notion that we will only consider information that's 
transparent.
    Mr. Baird. Thank you. I've got a whole notebook here. I 
could spend the rest of the day with you, but they tell me I've 
got 5 minutes, so thank all of you for being here, and I yield 
back.
    Mr. Casten. Thank you. And I now recognize myself for 5 
minutes.
    Dr. Allison, are you familiar with the phrase p-hacking?
    Dr. Allison. Sadly, yes.
    Mr. Casten. Could you give us just a simple overview of 
what that means for the Committee and how that can be used to 
draw bad conclusions from good data sets?
    Dr. Allison. Certainly. P-hacking is a term that it broadly 
includes multiple practices in which one adaptively analyzes 
data with the intent of producing a particular result in terms 
of a p-value, a p-value being a particular statistic that tells 
one about what we refer to as the statistical significance of 
the data, very, very loosely speaking, getting a finding. And 
one can continually reanalyze the data, one can analyze only 
males and only females separately. One can analyze only young 
and old. One can throw out an outlier, include an outlier, and 
transform the data until eventually one gets the result one 
wants. And so the practice of p-hacking undermines the 
replicability and validity of analyses.
    Mr. Casten. So that is a brilliant job of summarizing at 
least 3 weeks of my college statistics class. I appreciate it.
    So in the supplemental rule that the EPA released, they 
said that their intent is to, quote, ``reanalyze data,'' which 
they defined as ``to analyze exactly the same data to see if 
the same result emerges from the analysis by using the same 
programs and statistical methodologies that were originally 
used to analyze the data.'' To my way of thinking, that sounds 
like a recipe for p-hacking. Would you share that concern?
    Dr. Allison. Again, these are my own comments, but I would 
not describe it as a recipe, but I would describe it as an 
opportunity. And I think that this is again where the issue of 
more information is needed. One would hope that in fact with 
respect to transparency, then if EPA is going to go down that 
road, it might want to propose additional plans whereby they 
engaged the services of Dr. Nosek or other people who do these 
sorts of things so that their plans also became transparent and 
so that their reanalysis plans became shots they called prior 
to looking at and analyzing the data. That might be something 
in an ideal world. Whether that would always be practicable is 
unclear. Of course, there would need to be exceptions but it 
would be helpful.
    Mr. Casten. Thank you for that clarification. I really was 
thinking in the context of because the reanalysis would only 
apply to results where the data was there, we are limiting this 
that we have. And so, you know, accepting your very good 
comments that reproducibility cannot be the sole basis of good 
science, it would seem to me that reanalysis, as they're 
describing, is not even synonymous precisely with 
reproducibility. Yes or no, do you agree with that?
    Dr. Allison. If reproducibility is defined as the National 
Academies of Science Committee that I served on defines it, 
then reanalysis is at most reproducibility if it runs the exact 
same analysis as was initially run.
    Mr. Casten. OK. Dr. Rice, I've got another easy one for 
you.
    Dr. Rice. I had a follow-up comment on that----
    Mr. Casten. Well, let me--because we're tight on time----
    Dr. Rice. OK.
    Mr. Casten [continuing]. I'm sure as a medical doctor 
you're familiar with pre-existing conditions.
    Dr. Rice. Absolutely.
    Mr. Casten. Purely as an individual, not any associations 
you're with, do you have complete confidence that Congress will 
never remove the protections to people with pre-existing 
conditions?
    Dr. Rice. I can't comment on that issue specifically, but I 
can talk about the kinds of conditions that we collect and 
research. You asked about----
    Mr. Casten. Well, I asked the question because if we have a 
concern that our data may not always be kept private and that 
it may limit our ability to get insurance, get medical 
coverage----
    Dr. Rice. Yes. Oh, I see where you're asking.
    Mr. Casten [continuing]. Is it reasonable to assume that 
the average American may not want their health data to be in a 
publicly searchable database?
    Dr. Rice. Well, that I agree with. I think that the average 
American probably does not want their data about their mental 
health, their alcohol use, their tobacco behavior, their income 
on a public database that could potentially be hacked. And for 
environmental health data, it may be especially easy to figure 
out who people are because it has to do where people are 
located.
    So, for example, in my research we adjust for community-
level confounders, things like census-tracked income, census-
tracked education level, things that are associated with where 
the person lives. And so if you had 10 or 15 of those variables 
which are data sets, too, you could pretty easily figure out 
where that person is located. So I think that's a real----
    Mr. Casten. I always hate interrupting because our time is 
so short here, but if you could just with a limited time left--
--
    Dr. Rice. Yes.
    Mr. Casten [continuing]. In the supplemental rule that was 
revealed, EPA says that studies will be weighted not by 
scientific metrics but by the public availability of data and 
models. So can you just speak to what that weighting would do 
to the quality of data and, ultimately the ethics of----
    Dr. Rice. Yes.
    Mr. Casten [continuing]. Data collection, given what you 
just discussed?
    Dr. Rice. Certainly. That concerns me because environmental 
health research, we really need to adjust for those kinds of 
confounders that I just mentioned. Personal-level 
characteristics are really important so that we do the 
biostatistics right. So that would actually create a bias 
against research that really characterizes their study 
participants really well so that you can account for 
confounding. Those are the kinds of studies that are least 
likely to be able to meet this requirement.
    Mr. Casten. Thank you. And I have used up my time.
    Mr. Foster.
    Mr. Foster. Thank you, Mr. Chair. And I'd also actually 
like to start out by thanking the Ranking Member Lucas and the 
minority staff for the existence of Dr. Nosek on this panel. 
You know, for someone who's lived through the previous 5 years 
on this panel, seeing an entire panel, minority and majority, 
all with the dedication to getting the best science as the 
basis of public policy, it's thrilling.
    Now, to me, the privacy and PII are some of the toughest 
problems in everything that we're wrestling with here. So, 
first, what is the state-of-the-art on patient consent forms 
and data anonymization? Is there at least going forward a 
pretty good, you know, recipe for how you perform public health 
studies without making too many compromises?
    Dr. Birnbaum. So it's very difficult to completely protect 
privacy if you make the data fully available.
    Mr. Foster. Yes. But, for example, you know, does a typical 
consent form for a specific study allow that data to be used in 
a subsequent real scientific study----
    Dr. Birnbaum. Yes, so the types of terminology that goes 
into an IRB (institutional review board) protocol, a consent 
form, is that all attempts to maintain confidentiality will 
be--but you can't assure confidentiality.
    Dr. Sherer. Yes, just to jump in because I referenced one 
of the studies that we are supporting, there are ways to handle 
this in the consent process. And I think we have to be clear we 
don't just focus on what the scientists want to do. These are 
the volunteers that are participating and being transparent to 
them on what's happening with their data and that their data 
will be used for further research. And obviously there's always 
the risks, but people should be aware of the risks if they're 
participating.
    And one of the concerns that we have is that you can wind 
up biasing people who are involved in projects who don't want 
to participate if you put too much criteria on it, and then you 
don't have a full data set.
    Mr. Foster. Right. And presumably, if you ask them to 
consent to having their data used for multiple potentially 
unknown future studies, that's a much bigger ask than one 
specific study. You'll get drop-off that may or may not bias 
your patients and----
    Dr. Sherer. Yes, I think people are--you know, you have a 
pyramid of people who are willing to be involved at different 
levels, and it's just a matter of being transparent. I think in 
the case of some of the studies being discussed here that are 
using census data or medical record data, you're a lot further 
from that direct consent, and you have to be very careful about 
how that data is ultimately going to be shared.
    Mr. Foster. Now, in terms of data anonymization, I guess 
Dr. Rice mentioned the problem that if you just do a first-
order anonymization, it can be undone with access to other data 
sets. This is something we're wrestling with on my other 
committee. I chair a task force on artificial intelligence, and 
we are wrestling with the fact that artificial intelligence 
works better with big data sets, you know, like big sets of 
medical records. And what you want to do is give access to lots 
of researchers, very large data sets. And one of our witnesses 
was promoting a technology that goes by the name of homomorphic 
encryption, which allows you to publish an encrypted data set 
and ask very detailed statistical questions about that without 
actually having access to it.
    And I guess, Dr. Nosek, is that an approach your familiar 
with?
    Dr. Nosek. I am familiar with the general approach, not the 
particulars of that one, but yes, this is a very interesting 
set of emerging technologies. Alfred P. Sloan Foundation has 
supported a number of efforts in this regard that perturb the 
data in such a way that you can't identify any individual data 
point, but it still maintains the overall structure of the data 
so you can draw confident conclusions.
    Mr. Foster. Yes, because it seems like that's something 
where some effort in that direction could really be 
transformative to--your ability to make fewer compromises in 
this pyramid of people willing to come into this.
    Dr. Sherer. Just to add, particularly in a chronic disease 
like Parkinson's disease where it's a late onset, people are 
older in their life, one additional concern is that some of the 
data collection may have started decades ago, and you can't 
really go back in time to re-consent and re-set up the rules 
about that data. So I think one of the concerns is you'd still 
want to be able to use that data if you're changing the rules 
going forward on what is required with sharing. You can't go 
back 30 years when you started collecting the data.
    Mr. Foster. Well, yes, over Veterans Day weekend there was 
a veteran with Parkinson's probably from Agent Orange. And the 
questions of the--just the validity of the data that was 
collected, and I guess there's automatic consent in the 
military, yes, there was another comment.
    Dr. Rice. Yes. Oh, I just wanted to describe the process by 
which--when a study participant enrolls in a study, we have to 
specify exactly how we're going to use their data and what 
protections are going to be in place to protect that data. So 
really the same point that--studies that have already 
completed, these participants have already signed those consent 
forms, and those consent forms specified how the data could be 
used, so this would really impose a major limit on the kind of 
research that could be used by the EPA.
    Mr. Foster. Now, going forward, do you believe there's a 
satisfactory set of options for there, or is that still a work 
in progress in trying to maximize acceptance of participation 
on the study versus, you know, ability of it to be used?
    Dr. Birnbaum. So what is done frequently now--and this 
started a number of years ago--is you would basically give 
people two or three choices, you know, I don't want my data 
used for anything else, my data can be used for everything, you 
have to come back and ask me. And those are kind of the three 
basic options that exist. And going forward, that can be done. 
And there are some studies for the past couple of years where 
that has already been done. But if you go back before a couple 
years ago, people were pretty much consented to do exactly one 
thing.
    Mr. Foster. Right. And then you have to track down that 
patient, which has got to be a nightmare in many circumstances.
    And so maybe I'll just close with a pitch for the repeal of 
the unique patient identifier ban that the medical world has 
been living under, which is something we successfully passed 
through the House this summer and is awaiting action on the 
Senate, could be transformative to the ability of researchers 
to actually, you know, go through and do things like re-
contacting patients.
    Anyway, thank you, and yield back my time.
    Mr. Casten. Thank you.
    Before we bring today's hearing to a close, I really want 
to thank all our witnesses for coming before the Committee 
today and taking the time. Thank you very much.
    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.
    [Whereupon, at 12:36 p.m., the Committee was adjourned.]

                               Appendix I

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                   Answers to Post-Hearing Questions




                   Answers to Post-Hearing Questions

Responses by Dr. Jennifer Orme-Zavaleta

    [Despite repeated requests by the Committee over a period 
of ten months, EPA declined to submit any responses to the 
Questions for the Record put forth by Committee Members.]
Responses by Dr. Mary B. Rice

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


Responses by Dr. Todd Sherer

[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]



                              Appendix II

                              ----------                              


                   Additional Material for the Record




        Letter submitted by Representative Eddie Bernice Johnson
        
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]        

          Article submitted by Representative Suzanne Bonamici
          
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]          
          


      News release submitted by Representatives Suzanne Bonamici 
                            and Brian Babin
                            
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          Letters submitted by Representative Lizzie Fletcher
          
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]          

            Letter submitted by Representative Haley Stevens
            
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]           

             Letter submitted by Representative Paul Tonko
             
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           Memorandum submitted by Representative Sean Casten
           
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                  Documents submitted by Dr. Mary Rice
                  
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