[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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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
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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
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
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
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Memorandum submitted by Representative Sean Casten
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Documents submitted by Dr. Mary Rice
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]