TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act (House Hearing, October 27, 2021)
Summary
The printed record of "TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act," a hybrid hearing of the Subcommittee on Environment and Climate Change of the House Committee on Energy and Commerce on October 27, 2021, Serial No. 117-56, with Hon. Paul Tonko presiding. The sole witness is Michal Ilana Freedhoff, Ph.D., Assistant Administrator of the Office of Chemical Safety and Pollution Prevention at the U.S. Environmental Protection Agency. The record lists opening statements by Representatives Tonko, McKinley, Pallone and McMorris Rodgers and submitted material including letters of August 17, 2021, September 26, 2021 and October 27, 2021. The transcript closes with questions from Mr. Soto on the costs of implementing the new TSCA and service fees.
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“TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act (House Hearing, October 27, 2021).”
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[House Hearing, 117 Congress]
[From the U.S. Government Publishing Office]
TSCA AND PUBLIC HEALTH: FULFILLING THE PROMISE OF THE LAUTENBERG ACT
=======================================================================
HYBRID HEARING
BEFORE THE
SUBCOMMITTEE ON ENVIRONMENT AND CLIMATE CHANGE
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED SEVENTEENTH CONGRESS
FIRST SESSION
__________
OCTOBER 27, 2021
__________
Serial No. 117-56
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Published for the use of the Committee on Energy and Commerce
govinfo.gov/committee/house-energy
energycommerce.house.gov
_______
U.S. GOVERNMENT PUBLISHING OFFICE
56-830 PDF WASHINGTON : 2024
COMMITTEE ON ENERGY AND COMMERCE
FRANK PALLONE, Jr., New Jersey
Chairman
BOBBY L. RUSH, Illinois CATHY McMORRIS RODGERS, Washington
ANNA G. ESHOO, California Ranking Member
DIANA DeGETTE, Colorado FRED UPTON, Michigan
MIKE DOYLE, Pennsylvania MICHAEL C. BURGESS, Texas
JAN SCHAKOWSKY, Illinois STEVE SCALISE, Louisiana
G. K. BUTTERFIELD, North Carolina ROBERT E. LATTA, Ohio
DORIS O. MATSUI, California BRETT GUTHRIE, Kentucky
KATHY CASTOR, Florida DAVID B. McKINLEY, West Virginia
JOHN P. SARBANES, Maryland ADAM KINZINGER, Illinois
JERRY McNERNEY, California H. MORGAN GRIFFITH, Virginia
PETER WELCH, Vermont GUS M. BILIRAKIS, Florida
PAUL TONKO, New York BILL JOHNSON, Ohio
YVETTE D. CLARKE, New York BILLY LONG, Missouri
KURT SCHRADER, Oregon LARRY BUCSHON, Indiana
TONY CARDENAS, California MARKWAYNE MULLIN, Oklahoma
RAUL RUIZ, California RICHARD HUDSON, North Carolina
SCOTT H. PETERS, California TIM WALBERG, Michigan
DEBBIE DINGELL, Michigan EARL L. ``BUDDY'' CARTER, Georgia
MARC A. VEASEY, Texas JEFF DUNCAN, South Carolina
ANN M. KUSTER, New Hampshire GARY J. PALMER, Alabama
ROBIN L. KELLY, Illinois, Vice NEAL P. DUNN, Florida
Chair JOHN R. CURTIS, Utah
NANETTE DIAZ BARRAGAN, California DEBBBIE LESKO, Arizona
A. DONALD McEACHIN, Virginia GREG PENCE, Indiana
LISA BLUNT ROCHESTER, Delaware DAN CRENSHAW, Texas
DARREN SOTO, Florida JOHN JOYCE, Pennsylvania
TOM O'HALLERAN, Arizona KELLY ARMSTRONG, North Dakota
KATHLEEN M. RICE, New York
ANGIE CRAIG, Minnesota
KIM SCHRIER, Washington
LORI TRAHAN, Massachusetts
LIZZIE FLETCHER, Texas
------
Professional Staff
JEFFERY C. CARROLL, Staff Director
TIFFANY GUARASCIO, Deputy Staff Director
NATE HODSON, Minority Staff Director
Subcommittee on Environment and Climate Change
PAUL TONKO, New York
Chairman
DIANA DeGETTE, Colorado DAVID B. McKINLEY, West Virginia
JAN SCHAKOWSKY, Illinois Ranking Member
JOHN P. SARBANES, Maryland BILL JOHNSON, Ohio
YVETTE D. CLARKE, New York MARKWAYNE MULLIN, Oklahoma
RAUL RUIZ, California, Vice Chair RICHARD HUDSON, North Carolina
SCOTT H. PETERS, California EARL L. ``BUDDY'' CARTER, Georgia
DEBBIE DINGELL, Michigan JEFF DUNCAN, South Carolina
NANETTE DIAZ BARRAGAN, California GARY J. PALMER, Alabama
A. DONALD McEACHIN, Virginia JOHN R. CURTIS, Utah
LISA BLUNT ROCHESTER, Delaware DAN CRENSHAW, Texas
DARREN SOTO, Florida CATHY McMORRIS RODGERS, Washington
TOM O'HALLERAN, Arizona (ex officio)
FRANK PALLONE, Jr., New Jersey (ex
officio)
C O N T E N T S
----------
Page
Hon. Paul Tonko, a Representative in Congress from the State of
New York, opening statement.................................... 1
Prepared statement........................................... 4
Hon. David B. McKinley, a Representative in Congress from the
State of West Virginia, opening statement...................... 6
Prepared statement........................................... 8
Hon. Frank Pallone, Jr., a Representative in Congress from the
State of New Jersey, opening statement......................... 11
Prepared statement........................................... 13
Hon. Cathy McMorris Rodgers, a Representative in Congress from
the State of Washington, opening statement..................... 15
Prepared statement........................................... 17
Witnesses
Michal Ilana Freedhoff, Ph.D., Assistant Administrator, Office of
Chemical Safety and Pollution Prevention, U.S. Environmental
Protection Agency.............................................. 20
Prepared statement........................................... 23
Answers to submitted questions \1\
Appendix A and B responses....................................... 91
Submitted Material
Letter of August 17, 2021, from Mr. Pallone, Ms. DeGette, and Mr.
Tonko to Michael S. Regan, EPA Administrator, submitted by Ms.
DeGette........................................................ 69
Letter of September 26, 2021, plus six enclosures, from Michal
Freedhoff Ph.D., Assistant Administrator, EPA, to Mr. Pallone,
et al., submitted by Mr, Tonko................................. 73
Letter of October 27, 2021, from Kevin Serafino, Vice President,
Government Relations and Public Policy, Household and
Commercial Products Association, to Mr. Tonko and Mr. McKinley,
submitted by Mr. Tonko......................................... 88
Article of October 20, 2021, `` EPA's Chemicals Head Tells Staff
to Consider Work-Life Balance,'' by Stephen Lee, Reporter,
Bloomberg Law, submitted by Mr. Tonko.......................... 89
----------
\1\ The information has been retained in committee files and also
is available at https://docs.house.gov/meetings/IF/IF18/
20211027/114176/HHRG-117-IF18-Wstate-FreedhoffPhDM-20211027-
SD001.pdf
TSCA AND PUBLIC HEALTH: FULFILLING THE PROMISE OF THE LAUTENBERG ACT
----------
WEDNESDAY, OCTOBER 27, 2021
House of Representatives,
Subcommittee on Environment and Climate Change,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:33 a.m., in
the John D. Dingell Room 2123, Rayburn House Office Building,
and remotely via Cisco Webex online video conferencing, Hon.
Paul Tonko (chairman of the subcommittee), presiding.
Present: Representatives Tonko, DeGette, Schakowsky,
Sarbanes, Clarke, Ruiz, Peters, Dingell, Barragan, McEachin,
Blunt Rochester, Soto, Pallone (ex-officio); McKinley
(subcommittee ranking member), Johnson, Mullin, Hudson, Carter,
Duncan, Palmer, Curtis, Crenshaw, and Rodgers (ex-officio).
Staff Present: Jacqueline Cohen, Chief Environment Counsel;
Waverly Gordon, Deputy Staff Director and General Counsel;
Tiffany Guarascio, Staff Director; Anthony Gutierrez,
Professional Staff Member; Perry Hamilton, Clerk; Zach Kahan,
Deputy Director Outreach and Member Service; Rick Kessler,
Senior Advisor and Staff Director, Energy and Environment;
Mackenzie Kuhl, Press Assistant; Brendan Larkin, Policy
Coordinator; Kaitlyn Peel, Digital Director; Caroline Rinker,
Press Assistant; Nikki Roy, Policy Coordinator; Andrew Souvall,
Director of Communications, Outreach, and Member Services;
Rebecca Tomilchik, Policy Analyst; Sarah Burke, Minority Deputy
Staff Director; Michael Cameron, Minority Policy Analyst,
Consumer Protection and Commerce, Energy, Environment; Jerry
Couri, Minority Deputy Chief Counsel for Environment; Nate
Hodson, Minority Staff Director; Peter Kielty, Minority General
Counsel; Emily King, Minority Member Services Director; Mary
Martin, Minority Chief Counsel, Energy and Environment; Peter
Spencer, Minority Senior Professional Staff Member, Energy; and
Michael Taggart, Minority Policy Director.
Mr. Tonko. The Subcommittee on Environment and Climate
Change will now come to order.
OPENING STATEMENT OF HON. PAUL TONKO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW YORK
Today the subcommittee is holding a hearing entitled,
``TSCA and Public Health: Fulfilling the Promise of the
Lautenberg Act.''
Due to the COVID-19 public health emergency, members can
participate in today's hearing either in person or remotely,
via online video conferencing.
Members, staff, and members of the press present in the
hearing room must wear a mask, in accordance with the updated
guidance issued by the attending physician.
For members participating remotely, your microphones will
be set on mute for the purpose of eliminating inadvertent
background noise.
Members participating remotely will need to unmute your
microphone each time you choose to speak. Please note that,
once you unmute your microphone, anything that is said in Webex
will be heard over the loudspeakers in the committee room, and
subject to be heard by the livestream and C-SPAN.
So, since members are participating from different
locations at today's hearing, all recognition of members, such
as for questions, will be in the order of subcommittee
seniority.
Documents for the record can be sent to Rebecca Tomilchik
at the email address we have provided to staff. All documents
will be entered into the record at the conclusion of today's
hearing.
The Chair now recognizes himself for 5 minutes for an
opening statement.
Five years ago, the Frank R. Lautenberg Chemical Safety for
the 21st Century Act was signed into law to reform the Toxic
Substances Control Act, which regulates chemical substances in
commerce. That legislation was the result of a multiyear,
bipartisan effort. Members of this committee, including
Chairman Pallone, then-Chairman Upton, and John Shimkus played
pivotal roles in the development and the negotiations of the
bill.
This is our first oversight hearing of the Lautenberg Act
since its enactment, and I am happy to welcome Dr. Michal
Freedhoff back to the Energy and Commerce Committee.
Welcome.
Before her confirmation, Assistant Administrator Freedhoff
was a long-tenured public servant in the House and Senate, and
she was integral to the enactment of TSCA reform. Dr.
Freedhoff's knowledge of the law and scientific training makes
her well-equipped to lead this office and, in my opinion, get
the program back on track.
This is a big job. Tackling PFAS, asbestos, methylene
chloride, ethylene oxide, and other dangerous chemicals that
have sadly become household names must be a top environmental
and public health priority for this Administration.
Many people are aware that I had concerns with the
Lautenberg Act when it was enacted. I fully acknowledge that
the Toxic Substance Control Act of 1976 was broken, and the
2016 amendments would make numerous improvements over the
status quo, including explicit consideration of vulnerable
groups, and an expedited risk management process for certain
PBT chemicals. But I was worried that states would be more
limited in their ability to address chemical risks, especially
if the Federal program once again failed to work as promised.
Sadly, there have been numerous examples over the past five
years, during the early implementation of the law, of the
program being titled--tilted by political appointees strongly
in favor of an industry at the expense of science-based
protections for public health. Several of the first ten risk
evaluations have needed to be revisited, often for failing to
adequately consider potential exposure pathways, conditions of
use, and risks to vulnerable groups, including workers.
There have also been concerns raised about the scientific
integrity of the program. This is an office that does very
technical, science-based regulatory work. Ensuring scientific
integrity is paramount, so that EPA's experts can do the work
required by the law, free from political interference.
And while I am worried about reports of scientific
integrity violations in recent years, I am heartened by the
announced steps to create new safeguards within the office,
including establishing a science policy adviser position, and a
new science and policy counsel. I hope these efforts will work
seamlessly within the existing EPA scientific integrity
infrastructure, and employees will be able to report freely to
the agency's top scientific integrity official.
Finally, TSCA will play a critical role in EPA's recently-
announced PFAS strategic roadmap. The TSCA office will be
responsible for implementing a national PFAS testing strategy,
ensuring new PFAS are properly reviewed, and re-reviewing
previous PFAS decisions.
In the past I have raised concerns about the number of new
PFAS entering commerce through low-volume exemptions. I support
EPA's April decision to likely deny future LVE requests, and I
hope EPA will take additional steps to appropriately restrict
new PFAS in the future. I look forward to hearing more about
the Agency's ongoing work to use its TSCA authorities to
address PFAS risks.
There is no doubt of TSCA's potential to improve chemical
safety and protect public health, but it requires
Administration leadership that is committed to assessing,
evaluating, and managing chemical risks in a manner that
respects science and the law. I believe that is the direction
of the Biden Administration, and I look forward to today's
hearing to provide additional clarity on EPA's efforts to get
the TSCA program back on track.
Dr. Freedhoff, I want to thank you again for joining us
this morning. I look forward to your testimony, and to working
together to ensure that TSCA's authorities are used to the
fullest, as envisioned by the many members and stakeholders
that supported the historic reform effort.
[The prepared statement of Mr. Tonko follows:]
Prepared Statement of Hon. Paul Tonko
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Tonko. And that--with that, I yield back.
The Chair now recognizes Mr. McKinley, ranking member of
the Subcommittee on Environment and Climate Change, for 5
minutes for his opening statement.
Representative McKinley?
OPENING STATEMENT OF HON. DAVID B. McKINLEY, A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF WEST VIRGINIA
Mr. McKinley. Thank you, Mr. Chairman, and thank you, Ms.
Freedhoff, for coming here today.
From--ever since former chairman of this subcommittee, John
Shimkus, and his staff worked tirelessly to get the Lautenberg
Act passed in 2016, the first amendment--this--and this was the
first amendment in over 40 years, as I recall, in talking to
John about that. But now it is five years later, and this
committee, I think, apparently now, we are looking to see how
it has been implemented.
But with its passage, the Lautenberg Act provided for much-
needed changes, so that the United States could unlock the
potential of its chemical industry. The EPA administers the
statute. But unfortunately, instead of promoting innovation and
supporting the chemical industry, as the Act intended, it seems
like EPA is stifling innovation and creating barriers to
commerce for new and existing materials.
The chemical industry is--clearly, we all understand, it is
key to the components of our U.S. supply chain. We all can see
that getting products from overseas is not working very well.
The ports are backing up. Deliveries are missing deadlines. And
now, EPA wants to regulate more than just chemicals, like an
imported article that may--and that is the emphasis, that is
the operative--may contain a regulated chemical, thereby
challenging and disrupting that critical supply chain.
And look at this new chemical program, known as the gateway
to innovation. There is a significant backlog of new chemicals
at EPA. We are hearing that from suppliers, vendors, people
that have worked with the EPA. You may not think there is a
backlog; they think there is a backlog, and that is what is
important. So they are awaiting approval for their chemicals.
The recent changes, the policy changes at the EPA, will
only slow things down. Mr. Chairman, I would like to enter into
the record an article from Bloomberg about the memo that the
administrator produced, if you could, please, Mr. Chairman.
This is about a memo that just--it was last week that,
apparently, you told your staff in a memo, one, take more time
off, and then take an hour every day for lunch, not to be at
meetings on Friday, limit public engagement, improve meetings
by streamlining topics, requesting agendas, and keeping
conversations crisp, and not to take their home--their work
home with them, mentally. Seriously? And at the same time, you
are--typically, you are asking for more money, but you want to
work less.
So it is no wonder the EPA's chemical backlog is expanding.
How does this statement encourage a more streamlined chemical
review process?
There are other issues, too. And this committee will
discuss them today. But Mr. Chairman, Section 902 of the Clean
Future Act places a 3-year moratorium on permits, air permits
for plastic facilities, thereby preventing them from being
constructed over the next three years. Am I missing something
in all this?
The United States has been striving for robust chemical
industry. And how is that possible, if we have, one, a backlog
of bureaucratic delays in the chemical program; the email, or
memo, telling our staff to do less; and then a ban on
constructing plastic facilities, further restricting America's
access to U.S.-made PPE, gloves, shields, masks, gowns? These
are--all are necessary for our strategic national stockpile.
I don't understand what is happening under this
Administration. I thought John Shimkus's efforts with the TSCA
was to stimulate the potential of the U.S. chemical industry.
But it appears to me the policies that have been put forth in
the last ten months are doing diametrically opposite.
[The prepared statement of Mr. McKinley follows:]
Prepared Statement of Hon. David B. McKinley
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. McKinley. So with that, Mr. Chairman, I yield back the
balance of my time.
Mr. Tonko. The gentleman yields back. Before I recognize
the chairman of the full committee, Mr. Pallone, I would ask
that the entire subcommittee join me in wishing him a very
happy birthday.
[Applause.]
Mr. Tonko. I know that this additional digit that he has
added came with a lot of hard work on behalf of the people of
this country, as chairman of this full committee.
And Frank, thank you for the work on behalf of Build Back
Better, infrastructure, all of the Energy and Commerce agenda.
And with that, we recognize you for 5 minutes for your opening
statement.
OPENING STATEMENT OF HON. FRANK PALLONE, Jr., A REPRESENTATIVE
IN CONGRESS FROM THE STATE OF NEW JERSEY
Mr. Pallone. Thank you, Chairman Tonko. I am sure you are
aware, having been at the caucus this morning, that I am
surprised by people even mentioning my birthday, and
particularly the 70. But that is OK. Thank you so much.
I wanted to start out by just saying that we are,
obviously, continuing our work to ensure the legacy of my
Senator and mentor, Frank Lautenberg, who was the--you know,
who the TSCA bill is named after. And I, of course, want to
make sure that we live up to Senator Lautenberg's commitment to
protecting Americans from chemical exposure, particularly
children, but also pregnant women, workers, environmental
justice communities.
And this committee worked in a strong bipartisan fashion. I
know mention was made of Congressman Shimkus, who was so much
involved to finally get this landmark legislation signed into
law in 2016 by then-President Obama. And it updated and
modernized the Toxic Substances Control Act, otherwise known as
TSCA, for the first time in 40 years.
And of course, let me mention your outstanding work,
Congressman Tonko, in trying to get this over the line. You
really were taking the lead on it.
Unfortunately, the Trump Administration's implementation of
this law was tainted by secrecy and undue political influence.
The Trump Administration's actions undermined our efforts of
creating a strong Federal chemical regulatory system.
One of the key goals of the Lautenberg Act was to finally
give the EPA the tools it needed to address the threats of
harmful chemicals like asbestos, tools that the agency did not
have under the original TSCA law. Thirty-two years ago, EPA
finalized a rule banning asbestos, but the rule was struck down
in court two years later. The original TSCA simply did not give
EPA the tools it needed to address the risk, even though we had
known the dangers of asbestos for decades.
And as a result, asbestos is still being used in automotive
parts, and chemical manufacturing, and construction materials
all across the country, and the continued use of asbestos poses
a continuing threat to human health and the environment.
So, while the Lautenberg Act finally gave EPA the tools it
needed to address asbestos and other harmful chemicals, it
quickly became clear that the Trump EPA would not take the
needed actions. In fact, the Trump EPA's asbestos risk
evaluation was panned by the Science Advisory Committee on
Chemicals, and challenged in court.
But fortunately, with the new Biden Administration, the EPA
is under new leadership. The agency recently reached a
settlement to resolve the deficiencies in its asbestos work,
and is now on a path to properly address legacy exposures. I am
pleased to say that EPA appears to be moving to address risks
from many dangerous chemicals. The strong, credible Federal
regulatory regime we hoped for with the Lautenberg Act seems to
be in sight.
The EPA's TSCA office also played a critical role in
solving the rampant PFAS contamination problem affecting the
nation. I was relieved to see the comprehensive testing and
reporting requirements included in the Biden Administration's
PFAS roadmap issued by the Agency earlier this month, and the
roadmap includes critical pieces of the PFAS action plan that
has passed the House twice on a bipartisan basis, thanks to the
tireless work of Representative Dingell, and the steadfast
support of Representative Upton.
Thankfully, the Biden EPA, under the Administrator Regan,
Michael Regan, has committed the Agency to scientific integrity
and its critical mission to protect the public health and the
environment. The Agency is conducting a second look at the
flawed risk evaluations of the Trump Administration,
implementing TSCA as intended, and addressing the
disproportionate risk for environmental justice communities.
And I am very hopeful that, under the Biden Administration, the
TSCA office can operate free of political interference, and
make decisions based on science that will benefit public
health.
So this is an important oversight hearing, Mr. Chairman. I
thank you for this TSCA program, and the bipartisan law that so
many of us on this committee worked to get across the finish
line. As a friend of the late Senator Lautenberg and his
family, it is important to me that his environmental legacy be
honored in the implementation of the critical reforms that are
made in his name.
So I want to thank the assistant administrator for
testifying today, and look forward to the hearing on how the
EPA is working to get TSCA back on track.
[The prepared statement of Frank Pallone follows:]
Prepared Statement of Hon. Frank Pallone, Jr.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Pallone. Thank you, Mr. Chairman. I yield back.
Mr. Tonko. Chairman Pallone yields back. The Chair now
recognizes Mrs. Rodgers, ranking member of the full committee,
for 5 minutes for her opening statement, please.
OPENING STATEMENT OF HON. CATHY McMORRIS RODGERS, A
REPRESENTATIVE IN CONGRESS FROM THE STATE OF WASHINGTON
Mrs. Rodgers. Thank you, Mr. Chairman. Happy birthday, Mr.
Chairman. Good morning, everyone. Welcome.
This hearing is about the operations of the Office of
Chemical Safety and Pollution Prevention at the Environmental
Protection Agency, EPA, and especially this office's
implementation of Title 1 of the Toxic Substances Control Act,
or TSCA.
TSCA is unlike any other statute. It gives EPA broad
authority to regulate the entire chain of commerce, if EPA
finds it necessary to control an unreasonable risk presented by
a chemical substance under its conditions of use. With
authority this sweeping, it is fundamental that we, the
lawmakers, the policy-makers, oversee this office and these
programs.
This oversight today is even more critical, because of the
questions raised by the new expanded and precautionary
implementation direction being applied to the TSCA 2016
amendments. It is a direction that can wreak havoc on supply
chains, hurt our ability to lower U.S. greenhouse gas emissions
through free-market solutions and innovation, make inflation
worse, and hurt America's competitive edge against China.
Five years ago there was a consensus that parts of TSCA
were not performing well enough, and that it was hurting
consumer confidence. Attempts to create a mirror opposite of
TSCA were rejected by Congress. Instead, the 2016 TSCA
amendments were intended to reset more restrictive court
interpretations of TSCA, permit EPA to obtain more easily
information to support its TSCA work, enforce high-quality
science standards on TSCA activity, and make EPA's decisions
more transparent.
It was not the intent to replace risk-based decision-making
with assessment and regulation predicated only on hazard.
Precaution is not risk.
It was not intended to remove one unreasonable risk to
create another, more unreasonable risk for a society.
It also was not intended to shift EPA's focus from
reviewing and regulating certain types of chemicals to,
instead, regulating for other Federal agencies in EPA offices
and areas where Congress did not give them explicit authority.
Most importantly, Republicans on Energy and Commerce, when
we were in the majority in 2016, did not intend regulation
under TSCA. OK. When we were in the majority--I am going to cry
about it now--we did not intend regulation to stifle innovation
or interstate commerce. We did not intend for TSCA regulations
to go from the least to the most burdensome.
We are in the midst of a domestic supply chain crisis. We
cannot afford letting an inefficient, unreasonable TSCA
implementation further devastate innovation and America's
competitiveness.
These current choices hurt American leadership, and the
ability for people to raise their standard of living. For
example, TSCA Section 5 has long been considered the gateway
for American innovation. Multiple past EPA career managers of
the new chemicals program testified to this committee that new
chemicals tended to be greener and safer than the chemicals
they are replacing.
Yet, since 2016, EPA is only receiving one-third of the new
chemical applications it gets, and two-thirds of the year are
already past. EPA has only made 27 determinations on the 203
pre-manufacture notices it has received this year. Notably,
these decisions are required within no more than 180 days.
In addition, delays on EPA regulations of significant new
uses of existing chemicals average 1.3 years, allowing
competitors to commercialize some of these substances, and
defeating the purposes of issuing use conditions.
Failing to provide industry the confidence they and
downstream customers need regarding options to improve their
products and compete globally in a timely matter manner is a
significant shortcoming.
This is not a question of science or risk. This is a matter
of management, and that falls to the Agency and its leaders,
including the witness today.
Making OSHA and CPSC items also subject to TSCA
jurisdiction does not increase compliance, only enforcement and
penalty opportunities.
I look forward to this hearing today, and asking further
questions, and with that I yield back. Thank you.
[The prepared statement of Mrs. Rodgers follows:]
Prepared Statement of Hon. Cathy McMorris Rodgers
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Tonko. The gentlelady yields back.
The Chair reminds Members that, pursuant to committee
rules, all Members' written opening statements shall be made
part of the record.
And now we will introduce the witness for today's hearing.
We welcome the Honorable Michal Freedhoff, Assistant
Administrator of the Office of Chemical Safety and Pollution
Prevention at the United States Environmental Protection
Agency.
At this time the Chair will recognize the witness for 5
minutes to provide her opening statement.
Before we begin, I would like to explain the lighting
system. In front of our witness is a series of lights. The
light will initially be green. The light will turn yellow when
you have one minute remaining. Please begin to wrap up your
testimony at that point. The light will turn red when your time
has expired.
I recognize Assistant Administrator Freedhoff for 5 minutes
to provide an opening statement.
And again, welcome.
STATEMENT OF THE HON. MICHAL ILANA FREEDHOFF, Ph.D., ASSISTANT
ADMINISTRATOR, OFFICE OF CHEMICAL SAFETY AND POLLUTION
PREVENTION (OCSPP), U.S. ENVIRONMENTAL PROTECTION AGENCY
Dr. Freedhoff. Good morning, Chairman, Ranking Members, and
other members of the committee. I very much appreciate the
opportunity to speak with you today.
I have spent the majority of my career here, on Capitol
Hill, including time spent on this committee's staff, and it
really is a pleasure to be back.
One of the most professionally rewarding and challenging
opportunities I had during my time on the Hill was to work on
the much-needed reforms to the Toxic Substances Control Act, or
TSCA, a law that for nearly 40 years had largely failed to
serve its purpose.
Mr. Tonko. Excuse me. Yes, OK, we are just wondering if the
mike is on, or perhaps you need to be a little closer.
Dr. Freedhoff. It is on.
Mr. Tonko. OK.
Dr. Freedhoff. I can move it a little closer. Is that
better?
Mr. Tonko. Yes, I think that is better.
Dr. Freedhoff. OK.
Mr. Tonko. Thank you.
Dr. Freedhoff. OK.
Mr. Tonko. Sorry.
Dr. Freedhoff. No worries. There was widespread
acknowledgment across the political spectrum that TSCA was
broken, and that the public deserved better protections against
dangerous chemicals.
Now at EPA, I am fortunate to be able to work on the
implementation side. More than half a decade has passed since
the reforms became law, but there is still much more work to be
done in order to get TSCA implementation efforts back on track.
And I would like to emphasize just a few of the critical
building blocks that I believe are needed for a sustainable
TSCA program.
First, I would like to talk about resources. I was actually
shocked to learn that the previous Administration never asked
Congress for any meaningful new funding to reflect the new
responsibilities in the 2016 law. And although Congress told
EPA that it could offset up to 25 percent of some of its TSCA
costs through fees from chemical companies, we have only
recouped about 13 percent of those costs from fees, not 25
percent.
And these shortfalls have implications that are important
to all stakeholders. For example, we estimate that we have less
than 50 percent of the resources that we need to review and
approve new chemicals in the way Congress intended us to do.
The funding boost in the President's 2022 budget request would
be a significant downpayment, and we hope to work with you to
build on this in future years.
The second element of a sustainable program is strong
science and scientific integrity, which are essential for
earning and maintaining the public's confidence. When EPA says
that a chemical found in products that are used in homes,
schools, and workplaces is safe, it is in everyone's interests
for the public to be able to believe us.
Third, a sustainable TSCA program must have policies and
processes that will lead to legally and scientifically
defensible and protective chemical safety actions. The last
Administration finalized ten existing chemical risk
evaluations, and a great deal of work by EPA's fantastic career
scientists went into them. So, while some of our policy changes
may require some supplemental analysis for some of the first
ten risk evaluations, our goal is to do that extra work only
when a failure to do so would lead to a less protective
outcome, once we get to the rulemaking stage. The faster we can
move into risk management, the faster we can begin to provide
the chemical safety protections the law promised.
We are already implementing a number of key policy changes
for many of the first ten risk evaluations. We have reversed
the previous Administration's assumption that all workers
always properly use protective person--protective equipment.
And we have reversed the previous Administration's decision to
exclude exposures to chemicals from air, drinking water, and
disposal from risk evaluations, because this likely left some
exposures to the general population unaccounted for, including
exposures to fenceline communities located near industrial
facilities who may be disproportionately exposed.
But our goal is to move to rulemaking as soon as we
possibly can. As so many of you know, the litigation that
overturned EPA's 1989 ban on asbestos became an emblem for why
TSCA needed to be reformed in the first place. And I expect
that our proposed rule for asbestos would be the very first of
the first ten chemicals assessed under TSCA that we send to OMB
later this year.
I also wanted to highlight some of the work we have been
doing to improve implementation of the new chemicals program.
Earlier this year we announced policy changes with respect to
protecting workers and ensuring that the scope of new chemical
reviews aligns with Congress's expectations.
In addition, we have revised the process for review and
finalization of human health risk assessments, and established
a new internal advisory body to review and consider scientific
and science policy issues related to new chemical submissions.
But I want to be very clear: I don't believe that ensuring
new chemicals can be used safely and ensuring that the Agency
does these safety reviews quickly are mutually exclusive. We
can do both, and the law says we should.
Lastly, I wanted to touch on Administrator Regan's recent
announcement on PFAS, and the urgent health and environmental
threat they pose. I am just going to briefly describe one of my
office's contributions to the PFAS road map.
One of the biggest challenges we face is that most of the
thousands of PFAS that have been made or used have limited or
no toxicity data, which means we can't write a drinking water
standard or set a cleanup level, because we can't characterize
the health effects of the substances. And if we keep working on
this one PFAS at a time, we will never be able to fully solve
this problem.
Last week the agency announced a national PFAS testing
strategy that groups PFAS into categories for testing. The
first TSCA test orders to PFAS manufacturers, for about 20
different parts in 20 different categories, will go out in a
matter of months, and will provide the Agency with critical
health risk information that can be extrapolated to more than
2,000 other PFAS in similar categories.
In conclusion, I am fully committed to getting our TSCA
implementation efforts back on track, and to using those
authorities to ensure protections against dangerous chemicals
for the American people.
Thank you very much for inviting me today, and I look
forward to your questions.
[The prepared statement of Dr. Freedhoff follows:]
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Mr. Tonko. Administrator Freedhoff, thank you for your
testimony.
We will now move to member questions, and I will start by
recognizing myself for 5 minutes.
You have partners here in Congress that are ready to work
with you to make certain that TSCA is protecting Americans from
dangerous chemicals, as intended by the 2016 reforms that you
worked hard to enact. But there is much to do to get this
program back on track. And I believe it must start by ensuring
greater transparency of EPA's processes, and the use of
scientific data in its decision-making.
Sadly, this lack of transparency was a hallmark of the
previous Administration. In 2019 Chairman Pallone and I raised
concerns about EPA's decision to classify Pigment Violet 29
health and safety studies as confidential business information.
Section 14(b)(2) of TSCA is explicit that health and safety
studies are not prohibited from disclosure.
So, Administrator Freedhoff, do you intend to make all
health and safety studies public for all chemicals under
review?
Dr. Freedhoff. Sorry. Thanks very much for that question,
Mr. Chairman, and I agree that increased transparency was one
of the fundamental reforms that was included in the 2016 TSCA
amendments, and I--you know, it was also, as you know, one of
the more complicated sections to negotiate.
I do agree that the law requires health and safety studies
to be made public, and we are going to implement the law.
Mr. Tonko. And what other steps, if any, are you taking to
ensure greater transparency in the program?
Dr. Freedhoff. We have taken a number of steps fairly
recently. We moved the identities of almost 400 chemicals from
the confidential to the public part of the TSCA inventory, as a
result of a review that we did following a rule mandated by the
new law. And we are going to continue to be making information
like that public, as we are able to.
And we are also working especially hard at providing more
information about new chemicals, and making that information
more public as quickly as we can.
Of course, we do take very seriously our obligations to
protect confidential business information, and that is why
sometimes our reviews seem like they are taking longer than
they should, because we are really, you know, checking every
box to make sure we don't inadvertently release something that
we shouldn't.
Mr. Tonko. Thank you. Regarding PV 29, the draft risk
evaluation failed to consider worker exposures. This will be a
theme today, ensuring proper consideration of potentially
exposed or susceptible sub-populations, as required by the law.
So what steps are you taking to ensure vulnerable
populations, such as workers, are considered from the beginning
of the chemical review process?
Dr. Freedhoff. Thanks very much for that, for that
question, Mr. Chairman, because you are absolutely right, the
law requires us to consider exposures to potentially exposed
and susceptible sub-populations. That doesn't just include
workers. It also includes, you know, communities who live near
industrial facilities, who might be disproportionately exposed
to those chemicals.
So one thing we are doing, we--you know, we did announce
the reversal of the failure to consider all of the risks that
workers might pose, as part of our risk evaluations, and we
will be carrying that policy reversal forward, not just for the
first ten chemicals, but for the next 20, as well.
But what we are--another thing that we are doing is
creating a fenceline screening methodology that is intended to
make sure that we haven't inadvertently left communities out of
those risk evaluations. And we will be releasing that fenceline
screening methodology later this fall, both for public comment
and peer review, and expect to build on those efforts going
forward, as well.
Mr. Tonko. Thank you. Administrative Freedhoff, as a
scientist, I know you appreciate that concepts like best-
available science are highly influenced by the methods and
processes for selecting and evaluating which studies are being
considered. In order to determine how to apply the best-
available science, EPA uses a systematic review method to
inform chemical risk evaluations.
But in 2018 EPA published a final systematic method
document that was criticized by the scientific and
environmental communities. The National Academies Peer Review
Report, published in February of 2021, was also critical of the
2018 method.
I recognize and support EPA's decision to develop a new
method, subject to public comment and peer review. But at this
stage, EPA has yet to release a draft method, and it is unclear
what method is being used to develop current risk evaluations
underway. So when will the revised systematic review method be
publicly released?
Dr. Freedhoff. Thanks very much for that question. I just
want to make clear, first of all, that EPA hasn't been using
that older method in some time. And the career scientists in
OCSPP have been working with their colleagues in the Office of
Research and Development to make sure, even in advance of the
Critical National Academy report that you referenced, that our
systematic review process was made more robust.
I expect that we will be releasing the methodology, the new
methodology, for both public comment and peer review later this
year.
Mr. Tonko. OK. With that I will now recognize
Representative McKinley for 5 minutes to ask questions, please.
Mr. McKinley. Thank you again, Mr. Chairman, and thank you
again for this hearing. This is--speaking for John Shimkus on
this, this is something that was very important to him.
So, if I could, back--there was an overwhelming consensus
in the--in late winter and in the spring of 2020, that, one,
there was a shortage of personal protective equipment needed in
America, we--and secondly, we needed to manufacture more in the
United States. And those that were involved in the Strategic
National Stockpile also concurred that there was an
insufficient supply of PPE available, and it led to a critical
shortage.
Now, Assistant Administrator, Section 902--just in your
opinion, I know that you haven't crafted the bill, but it is
out there before us--Section 902 of the Clean Future Act
restricts the building or expansion of American plastic
manufacturing industries--facilities.
So my question, how--in your opinion, how will this policy
promote the additional availability of PPP [sic] in the United
States, if we are not manufacturing more?
Dr. Freedhoff. Thanks very much for that question, and I
believe that section of the Clean Future Act relates to the
Clean Air Act, and I think I need to take that specific
question back to our air office.
But if you don't mind, I just wanted to note that, in the
pesticides office, which is in my part of the EPA, we have
actually worked really, really closely with a lot of
manufacturers to make sure that those supply chain stresses are
not felt.
Mr. McKinley. If I could recover my--that--we are not
hearing the same. They are not--the people that I am talking to
throughout West Virginia and places are not concurring with
that, that there are delays in--and they are very concerned
about the potential. It is the lack of clarity, the uncertainty
that is swirling because this legislation could go into effect.
Now, so if I could, we know the supply chains or--for
articles are, one, focused on material declarations; and two,
they are complex and multi-layered. I would concur with you on
that. So it will be virtually impossible to identify each and
every chemical in each and every imported article. The
Lautenberg Act was not intended to regulate items, where the
likelihood of exposure to a chemical is just highly unlikely.
So by trying to assess every chemical in every product, it
could take years to figure out what chemicals are in
production.
So, Administrator, so if Congress bans the construction of
plastic facilities, and the EPA pursues these bureaucratic
delays in importing goods under TSCA because they might contain
a chemical, how does the U.S.--how do we in America avoid
additional future supply chain shortages?
Dr. Freedhoff. So first of all, I think I would say that
the Agency is equally concerned about supply chain shortages.
And I think, you know, I think it is important to note that the
rule that regulated articles that is causing these supply chain
concerns was actually finalized by the Trump Administration.
And I actually believe that the Trump Administration made every
effort to reach out to industry and explain what their plans
were for that rule and seek feedback.
But it wasn't until I had been at the Agency for just a few
days, where industry started to realize, after this rule was
already finalized, what the implications would be on their
supply chains. So we actually took immediate action under the
Biden Administration to extend the compliance date for that
rule, which, again, wasn't finalized by us. And we are still
working to address and understand those concerns in a
reasonable and practical way, and----
Mr. McKinley. Thank you.
Dr. Freedhoff [continue]. I commit that I will continue to
do that.
Mr. McKinley. If I could, Administrator, and as to your
email, the memo, we have heard from the chemical industry in
West Virginia, and they have already previously had problems
accessing guidance from the EPA. It is just the bureaucratic
delays that are out there. They were already seeing this.
And now, by virtue of this memo of reduced--no meetings on
Friday, you are reducing their access to you by 20 percent. And
I don't understand that. I don't agree with that. I think what
you are doing by your memo is you are only going to make it
worse across--in trying to consolidate and move things down the
food--the pipeline. I am concerned about that. I am afraid it
is just going to make it worse.
So I hope you do revisit your constriction of time and
access and availability. You have got great staff. Let's get
them involved with the industry. They are crying out. They need
more help. They don't need less access to you.
So with that, Mr. Chairman, I yield back the balance of my
time.
Mr. Tonko. The gentleman yields back. The Chair now
recognizes Representative Pallone, full committee chair, for 5
minutes to ask questions, please.
Mr. Pallone. Thank you, Chairman Tonko. In my opening
statement I mentioned that giving EPA the tools to finally
address this asbestos risk was an important goal of our TSCA
reform work. And, of course, our witness today was a part of
that work, and I think she knows the importance of addressing
asbestos as well as anyone.
So let me start by asking Dr. Freedhoff, what is your
office doing now to address the risk of asbestos, and what is
the timeline for EPA action on it?
Dr. Freedhoff. Thanks very much for that question, and
also, happy birthday.
Mr. Pallone. Thank you.
Dr. Freedhoff. You know, I don't even remember being in a
room with you, talking about TSCA, where the symbolic nature of
asbestos and EPA's previous failure to regulate it wasn't
brought up. And I don't think that symbolism is lost on anyone
at the Agency, either at the career level or the political
level, as we move forward with proposing our very first rule
under the--of the first ten risk evaluations under TSCA.
I expect that that proposed rule will go to OMB for
interagency review before the end of this calendar year. And
then I also expect that our scope for the next part of the
asbestos risk evaluation that addresses the uses and fiber
types that the previous Administration excluded will go--also
be ready, I think, roughly by the end of this year, and that we
expect to finish that risk evaluation by the end of 2024.
Mr. Pallone. All right. Thanks so much.
Now, obviously, a lot of work done on asbestos under the
previous Administration was criticized and challenged in court.
So how do you work to overcome the deficiencies in the EPA's
asbestos work to date? How do you overcome that?
Dr. Freedhoff. I think getting the program on track
generally is going to be a work in progress.
As I mentioned, you know, it was in--five years since the
law passed. The first time that Congress was ever asked for
additional funding to reflect the additional workload was in
this President's first budget request.
And, you know, the fees rule that allowed EPA to collect up
to 25 percent of some of its costs and fees, that wasn't even
finalized before the end of--or until the end of 2018, I
believe. And all of the costs of the first ten risk evaluations
weren't even subject to the fees.
So it is sort of a series of compounding resource errors
that also prevent us from hiring the types of scientific
experts we need. And everyone has been sort of working on a
shoestring for a long time now, and I think that is going to
take a lot of time to get back on track.
I will say that the staff are creative, smart, and
incredibly resilient, and I am very lucky to be working with
them. But they are a staff under stress, not just in my part of
EPA, but in--I think across the whole Agency.
Mr. Pallone. OK. And my last question is, how will the
work--I mean, obviously, since asbestos has always been an
example for other chemicals, as you mentioned, under TSCA. But
how will the work you are doing to course-correct on asbestos
inform your work on other chemical substances?
Dr. Freedhoff. I think, as we look at the legacy exposures
of asbestos, and work with our counterparts in the office that
handles RCRA and the Superfund law, I think we are going to
learn a lot from that engagement.
And we are working much more closely across the Agency
with, you know, the water office, the air office, and the
Superfund office, as we go through both the risk evaluation
stage and the risk management phase. So I think we are--I think
we will learn a lot about asbestos, and I think we will also
learn a lot about how to handle impurities in chemicals that we
study, as well.
Mr. Pallone. Well, thank you. And, I mean, obviously,
ensuring the scientific credibility of risk assessment and risk
management under TSCA is essential to protecting public health
and earning the public's confidence. So I just wanted--I
appreciate you coming back to the committee to testify today,
and the work you are doing to implement the reforms that we
worked so hard to put in place.
And hopefully, we will soon see long-overdue action from
EPA on asbestos and other dangerous chemicals, and I look
forward to working with you and others at the EPA to ensure
that the TSCA offices is fulfilling its mission and providing
the resources. So thank you again.
And thank you, Mr. Chairman, for all your work on this.
Mr. Tonko. The gentleman yields back. The Chair now
recognizes Mrs. Rodgers, the full committee ranking member, for
5 minutes to ask questions, please.
Mrs. Rodgers. Thank you, Mr. Chairman. As I stated in my
opener, TSCA is an important law, with unique and expansive
authorities. This authority should be used, but with care,
prudence, and predictability. Without these features, we risk
losing the enormous innovative benefits we realize from
chemical manufacturing.
I am also very concerned that, if we do not get it right,
we will hurt innovation in this country, and discourage
investment. This could lead to fewer products that are cleaner
and greener.
This Administration must be serious about making decisions
within the statutory deadlines for new chemicals. These
chemicals are the next generation of American innovation for
products that directly improve the standard of living for our
families, and contribute to our global competitiveness to beat
China.
The 90-day review period for new chemical submissions was
unaltered by Congress in the Lautenberg amendments. However,
EPA's new chemical division has only been able to complete its
review on a small portion of the pre-manufacturing notices
submitted since January 2020, within the 90-day review.
According to EPA's Office of Congressional and
Intergovernmental Affairs, 153 pre-manufacturing notices have
been pending a decision at EPA for more than six months.
In addition, according to EPA's new chemical website, it
appears that only eight submissions were finalized within the
90-day review.
Assistant Administrator Freedhoff, how does EPA track the
progress of new chemical reviews, and who is in charge of that
progress?
And who is in charge of ensuring EPA completes its reviews
within the statutory deadlines?
Dr. Freedhoff. Thanks very much for that question,
Congresswoman. And I just want to say personally to you that I
don't actually think that innovation and safety are in conflict
with each other. I think we can do both of those things, and I
think we can do better, and I hope that we will.
I would like to talk a little bit about the backlog of new
chemical submissions. In August of 2017, the Trump
Administration issued a press release that described the end of
the new chemicals backlog. And what they said in that press
release was that the agency had worked its way down to just
having 308 cases under review in front of the Agency, and said
that that represented a typical active workload.
As of a couple of weeks ago, I think October 12th, we had
319 cases pending before the Agency, and 58 of them were
actually waiting for industry action, not EPA action. So I
actually think we are also operating under a typical active
workload, as has been historically the case for the past few
years.
But I do want to go back to the--to what I--the point I
made a little earlier, which is that we are operating with less
than 50 percent of the resources that we think we need to
operate the new chemicals division in the way that Congress
expects us to. And I really hope to work with you to address
those problems and challenges going forward.
Mrs. Rodgers. OK. I know that Congressman Shimkus, when he
was subcommittee lead for the Republicans, also pushed the
importance of the 90-day review.
Dr. Freedhoff. Yes.
Mrs. Rodgers. It is important to that certainty. TSCA's
Section 2(b)(3) specifically states, ``It is the policy of the
United States that TSCA should not be exercised in such a
manner as not to impede unduly or create unnecessary economic
barriers to technological innovation, while fulfilling the
primary purpose of this Act.'' It seems pretty clear that
Congress does not want EPA implementation to create backlogs
that impede innovation and, particularly--and especially
potentially make us less competitive, globally.
So I would also like to ask, when will the backlog of
chemicals without decisions within 90 days be resolved?
And will you commit to me that your office will meet its
statutory deadlines for Section 5?
Dr. Freedhoff. I want to make clear to you that, when we go
longer than 90 days, it is generally because the company has
asked us to extend the deadline for review. Sometimes that is
because they have new information that they are giving to us
late in the process, and sometimes, especially in the past few
years, it is because they disagree with the conclusions of our
risk assessments, and want to convince us to change our minds.
So, in some cases, we have been waiting years to get
information that we have asked for for companies.
Mrs. Rodgers. OK.
Dr. Freedhoff. And that is why----
Mrs. Rodgers. OK.
Dr. Freedhoff [continue]. We can't move forward with a
decision----
Mrs. Rodgers. So, bottom line, we want to make sure that we
are fulfilling the statutory deadline. That needs to be the
goal, no matter who is in the White House.
Dr. Freedhoff. I share the goal. I do.
Mrs. Rodgers. And then, finally, I just would like to ask
you to address if you take into consideration the impact of
these assessments on national security interests, climate
priorities, and infrastructure development.
Dr. Freedhoff. TSCA requires us to consider that. And as
we--especially as we move into the existing chemical risk
management phase, we are required to think about national
security, critical economic needs, and costs. It is a risk-
based law, and I support the risk-based approach to chemicals
regulation.
Mrs. Rodgers. OK, thank you.
I yield back.
Mr. Tonko. The gentlelady yields back. The Chair now
recognizes Representative DeGette, who also serves as chair of
the Subcommittee on Oversight and Investigations.
Representative DeGette, you are recognized for 5 minutes.
Ms. DeGette. Thank you so much, Mr. Chairman.
Dr. Freedhoff, it is really good to see that this critical
EPA program is being led by somebody who has a deep commitment
to protecting public health. And I want to thank you.
In 2016, as has been mentioned, colleagues on both sides of
the aisle, led by our former colleague, Mr. Shimkus, worked to
enact the Lautenberg TSCA reform bill, and we had hopes that it
would fix some of the longstanding problems with the program.
And so, obviously, I was frustrated and disappointed how
the previous Administration abused its responsibilities under
the law. But I was even more alarmed to hear allegations by
career scientists about a disregard for science and
transparency, not just from the political appointees of the
previous Administration, but from some of the career managers,
which alleged that these actions continued even into this
Administration.
And I know you were also disturbed by this allegation, so I
really appreciate you responding to the letter that I sent
with--along with Chairmen Pallone and Tonko on this matter.
And Mr. Chairman, I would ask unanimous consent to put a
copy of my letter and the response into the--or our letter and
the response into the record.
Mr. Tonko. We will do those at the end of the----
Ms. DeGette. Thank you.
Mr. Tonko. All right.
Ms. DeGette. Now, Dr. Freedhoff, I want to ask you--and I
will give you the time--what have you done to address these
concerns since coming to the Agency?
Dr. Freedhoff. Thanks very much for giving me the
opportunity to talk about something that I think is vitally
important to restoring the credibility of the Agency.
And for years, just like you, before I started at EPA, I
was hearing about the intense pressure that the previous
political leadership placed on both managers and scientists in
the new chemicals division, and how they pushed them to review
and approve new chemicals as quickly as they could.
So when I first arrived at the Agency--shortly afterwards,
in mid-March--I was actually approached by a career scientist
who conveyed some of their concerns about human health
assessments in the new chemicals division. And I took those
concerns right to the Agency scientific integrity official.
I then started to talk to people, including former
employees of the new chemicals division, some of whom actually
told me that they left their jobs because of the concern that
they felt with the approaches that were taken.
So one of the steps we took--and this is something that we
haven't shared publicly to date--is that we started in April,
when the scientific integrity official and I found a way to
initiate a review of a small number of human health hazard
assessment cases that concerns had been raised about. And I
have shared relevant information about that review with the
inspector general, in case our review efforts helped theirs.
And this is just generally a summary of what I have learned in
the past months, from all of these different efforts.
So first, there are sometimes really serious questions
about just how hazardous a new chemical is found to be, in the
end, even though--even if there is general agreement that a
hazard exists. And that presents some implications, or the
potential for implications for our regulatory efforts.
I have also really consistently heard that there are--that
the scientific basis for changes to the assessments is not
always well explained or understandable.
And I also think that there are some legitimately difficult
questions about the processes and the science associated with
reviewing new chemicals.
And I can't underscore enough how seriously I have taken
these concerns since I started at the--since I first heard
about them at the Agency. And these are some of the steps that
we have taken so far to address them.
So I have personally let the inspector general know that we
will cooperate fully with their investigation.
We have launched an entire series of scientific integrity
training for the office.
We have put into place new ways that scientists who feel
like there is a disagreement can elevate those--their concerns,
and get a review.
We have hired someone to come in and talk to the division,
and get--and make recommendations for us for how to improve,
and we have changed the way our recordkeeping practices are
done.
And it is going to take some time, but I am committed to
it.
Ms. DeGette. Thank you so much. And I gave you the time to
really answer it, because we need to understand that it is
going to take some time, and it is going to take some effort.
And in the coming months, I know Chairman Tonko and Mr.
Pallone and our friends on the other side of the aisle, we are
all going to be watching and working with you to make sure that
you put the safeguards in place, and that you get back to the
scientific integrity.
Thanks, and I yield back, Mr. Chairman.
Mr. Tonko. The gentlelady yields back. The Chair now
recognizes the gentleman from Ohio.
Representative Johnson, you are recognized for 5 minutes,
please.
Mr. Johnson. Well, thank you, Mr. Chairman. You know, some
of us in this subcommittee were here--I was one of them--when
we passed this legislation over five years ago. It was a good
example of the kind of bipartisan work this committee is
capable of. It was an effort to modernize TSCA and improve
chemical safety, while making sure that we can still foster
American innovation in the 21st century.
And while we are conducting the necessary oversight here
today, I want to be clear, Dr. Freedhoff, we want your office
to be functional and effective for the American people. We all
want to protect workers and consumers. But to do that, the
Office of Chemical Safety and Pollution Prevention has to be
running smoothly, and keep its focus on the task at hand.
Dr. Freedhoff, you have outlined some big plans for your
time in the Biden Administration, but I do have some concerns
that, while we are hearing about delays, lack of certain
technical expertise, and other issues in your office, you want
to expand into some areas where, frankly, your office has never
gone before.
So Dr. Freedhoff, in 2019 the U.S. Court of Appeals for the
9th Circuit underscored TSCA's role as a gap-filling statute,
and that TSCA was never meant to regulate discharges,
emissions, ambient air, or consumer products. Yet, a few months
ago, the EPA announced it would potentially expand the scope of
the risk evaluations to address potential concerns with
chemicals that are traditionally regulated under other
statutes, such as the Clean Water Act or the Clean Air Act.
The problem with TSCA in the past has been that courts have
rejected the EPA's interpretation of the law. So does the EPA
disagree with the 9th Circuit, and instead believe TSCA
supersedes these other statutes, or that it should regulate
discharges into air and water, where they are already regulated
by those other laws?
That is a that is a yes-or-no question: Do you guys
disagree with the 9th Circuit?
Dr. Freedhoff. I don't disagree with the 9th----
Mr. Johnson. You don't disagree with them? OK, good.
Does the EPA's chemicals office coordinate with other
departments and programs within the Agency to make sure you are
in compliance with what the 9th court's rulings were?
Dr. Freedhoff. Yes, regularly.
Mr. Johnson. OK. In some cases the EPA is undertaking
multiple assessments of the same chemical. For example, a
chemical can be assessed under TSCA and under IRIS.
Can you discuss how EPA ensures that there aren't
duplicative efforts going on for chemical assessments, and
whether TSCA's scientific quality requirement criteria are
applied to assessments from these other programs?
Dr. Freedhoff. Yes, thanks very much for that question.
TSCA requires us to use the best available science. So if there
is an IRIS assessment on a chemical that we are evaluating, we
would be obligated to use that science. And we have a very good
and strong working relationship with the Office of Research and
Development.
But because TSCA also requires us to consider exposures,
conditions of use, the potential for environmental damage, you
know, and industry information about what the chemicals are
needed for, we wouldn't be relying exclusively on an IRIS study
for our work. We really do take the best available science
directive very seriously, and are prepared to look at all
information as we make our decisions and do our work.
Mr. Johnson. OK. Well, it almost sounds like you are
backtracking on the 9th Circuit position, because if IRIS and
FIFRA and--if they are already doing those things, why do you
feel that your office has to do them, too?
Dr. Freedhoff. IRIS's----
Mr. Johnson. It sounds like duplication to me, and that is
costly.
Dr. Freedhoff. I don't think an IRIS study and a risk
evaluation are the same. And IRIS is a non-regulatory document.
It is just the science that we use to inform our regulations.
It is not the regulations themselves.
Mr. Johnson. OK.
Dr. Freedhoff. And we are committed to--I want to do my
job, not the air office's job, or not the water office's job,
either.
So I believe that Section 9 of TSCA gave the Agency clear
direction for when TSCA should be the regulating law and when
the Agency should refer exposures or risks that it might find
to other parts of the Agency. And we will be following that
part of the law.
Mr. Johnson. OK, all right. I have another question, but I
will make that for the record.
[The question submitted by Mr. Johnson for the record
follows:]
[The information appears at the conclusion of the hearing.]
Mr. Johnson. Mr. Chairman, I yield back.
Mr. Tonko. The gentleman yields back. The Chair now
recognizes Representative Schakowsky, who also serves as chair
of the Subcommittee on Consumer Protection and Commerce, and we
welcome the gentlelady from Illinois.
Ms. Schakowsky. Thank you so much. So I want to talk about
phthalates. They have been banned by the U.S. Consumer Product
Safety Commission because of the endocrine disruption substance
that they are, and especially worrisome for pregnant women and
children.
Do you know, back in 2008, when I was helping to pass the
Consumer Product Safety Improvement Act, we banned phthalates
for children's toys?
So right now, the EPA completed its scoping of several
high-priority phthalates in September of 2020. The next step in
the process in a risk evaluation follow-up. It is still
happening.
I guess what I am really confused about is, if we have
already made a determination that phthalates are a problem, why
is it that the EPA is still considering risk evaluation on
them?
Dr. Freedhoff. I think I appreciate that question, and I
remember working closely with your staff in 2008 on those
provisions, so I am glad to be reminded of that, as well.
I think the CPOC, when it looked at those phthalates, was
really only looking at them as they relate to children's
products. They weren't looking at them as they relate to other
things that those phthalates are used for. And TSCA risk
evaluations ask us to look at all the conditions of use, and
propose regulations to address risk across all of the uses, not
just the children's products.
So I can assure you we will be looking at what the CPOC
did, and we are--you know, we would consider that to be, you
know, some of the best available science that we are required
to consider, as well. But I do think that what we are looking
at is potentially broader than what the CPOC did in the past.
Ms. Schakowsky. So we are thinking that maybe phthalates
aren't a problem?
Dr. Freedhoff. No, no----
Ms. Schakowsky. In some other ways?
Dr. Freedhoff. Not that. I am saying that we are going to
be looking at more than just children's products, and more
than--you know, which I think is what the CPOC looked at in its
review, years back. I am not opining--I am not suggesting that
the CPOC did anything wrong.
Ms. Schakowsky. OK. I also wanted to talk about testing on
animals. And I have a bill, the Safety--Safe Cosmetics and
Personal Care Products. And the bill that I had would ban all--
almost all--animal testing.
And since the publication of the document--let me see what
document I am referring to--so I was encouraged to see that--
the publication of the strategic plan to promote the
development and implementation of alternative test methods for
animal testing in the TSCA proposal. So where are we with that?
I would like to see--as much as possible, get rid of
dangerous animal testing.
Dr. Freedhoff. Absolutely. I--actually, some of the
briefings that I have had on the science associated with
developing different ways to test, other than using animals,
have been among the most interesting and exciting briefings I
have had since coming to the Agency. And it is an area where
our scientists are collaborating really well with the Office of
Research and Development.
And in some cases, the techniques that we are developing
that don't use animals are actually better and more predictive
than the--than actually testing on animals, because, you know,
the way an animal breathe isn't necessarily the same as the way
a person breathes. And the techniques that we are developing
reflect those differences.
So I think there is an Agency-wide commitment to continue
to pursue that science, and continue to incorporate those
methods as soon as they are available.
Ms. Schakowsky. OK. Well, I have just a--I have a little
time left. Let me just go back to phthalates for a minute.
I hope that this decision will be made soon, because I
think there is so much evidence now already that phthalates are
a problem. The endocrine problems, the--for children and for
pregnant women--that I don't know what else you are looking
for, exactly.
Dr. Freedhoff. I appreciate that, and I think what TSCA was
designed to do is tell the Agency to look at every single use
of a chemical, and----
Ms. Schakowsky. So what would that be?
Dr. Freedhoff [continue]. All possible uses----
Ms. Schakowsky [continue]. That would affect human beings
that you don't already--have seen the dangers?
Dr. Freedhoff. I am not saying that the Agency doesn't have
science available to it. I am saying that the point of TSCA was
to write it all down in one place, and assess the potential for
exposures across a range of uses, and then recommend risk
management rule-makings to----
Ms. Schakowsky. So let----
Dr. Freedhoff [continue]. Protect people against the risks.
Ms. Schakowsky. Give me an example of a range of use that
might expand the phthalate removal.
Dr. Freedhoff. I think there is more phthalate--I think
there are phthalates in more than just children's products, and
I don't believe there are regulations that address phthalates
in products that aren't children's products.
So doing the TSCA risk evaluation, if we find risks that
people might be getting exposed from different things, would
also allow us to write regulations to address those risks that
don't currently exist.
So I think we could end up with a more protective outcome,
not a not a less protective or duplicative one.
Ms. Schakowsky. OK, thank you, and I yield back.
Mr. Tonko. The gentlelady yields back. The Chair will now
recognize, virtually, I believe--logged in is the
representative from North Carolina. I recognize Representative
Hudson for 5 minutes, please.
Mr. Hudson. Thank you, Mr. Chairman. And thank you to Dr.
Freedhoff for being here with us today. It is great to see you
back in Rayburn. Congratulations on your new position. I can
think of no one who is more qualified.
I would like to start first by applauding the Administrator
Regan for releasing the PFAS Action Plan last week. We fought
hard to address PFAS pollution in our community since the
Chemical GenX has impacted the Cape Fear River Region. I had
the opportunity to speak with the administrator ahead of the
announcement, and was encouraged by the seriousness with which
he is addressing this issue, and the ambitious goals set forth
in the plan.
Specifically, the action plan states, ``The EPA expects to
exercise its TSCA authority to require PFAS manufacturers to
conduct and fund the studies,'' and plans to ``issue the first
round of test orders on selected PFAS by the end of the year.''
Dr. Freedhoff, can you clarify? Is the goal to issue an
order on these testing requirements within the year, or that
the testing on selected PFAS will be completed, and at EPA
within one year?
Dr. Freedhoff. Thanks very much, and I apologize, it was a
little bit difficult to hear you. And I think what you were
asking is when we will be issuing test orders for PFAS under
our national testing strategy.
Mr. Hudson. Well, according to what the EPA said, you are
going to require PFAS manufacturers to conduct and fund these
studies, and issue the first round of test orders by the end of
the year. So----
Dr. Freedhoff. Yes, yes. So we will be issuing the first
round of test orders by the end of this year, and we expect the
data that we get from that to be extrapolated to fill health
information gaps associated with about 2,000 different PFAS.
But those are just the first test orders in the PFAS testing
strategy. We do expect to continue to fill those information
gaps using our authority in the months and years to come.
Mr. Hudson. How quickly do you think we can--will see
results from that first round of test orders?
Dr. Freedhoff. I think we are in the process right now of
writing up those test orders, and TSCA allows us to tell the
industries that we are asking for information from what
experiments they need to conduct, and what data they need to
provide us with. And we are not done writing that up yet.
When we do issue the orders, it will be public. And I think
the timeline for industry getting the information back to us
will depend a little bit on what we ask them to do.
Mr. Hudson. Do you think, average, a year, six months,
multiple years?
Dr. Freedhoff. I would say months to a year or two would be
my guess, but it, honestly, is just a guess at this point.
The staff is hard at work writing, you know, writing the
test orders, and figuring out what reasonable deadlines are for
getting the information back to us, because we also want to
make sure it is the right data, and it is robust enough, and
that industry has had time to develop it.
Mr. Hudson. I think that is going to be kind of a--the
delicate balance, as--where our communities are desperate for
this information. But we do want to be reasonable, and give
them a reasonable amount of time. But--so I guess that is going
to be one of the issues we really need to work through.
One of my questions, though, is do you believe there is
enough domestic laboratory capacity for companies to conduct
this testing to a level that meets TSCA science quality
requirements?
Dr. Freedhoff. I don't have a reason to believe that there
isn't. But that is something we would consider if, you know, if
we were provided with evidence that there was a lab capacity
issue.
I think that one of the advantages of the PFAS testing
strategy is that, instead of testing one chemical at a time
until we have gone through, you know, the thousands that have
historically been made or used in this country, we are instead
just targeting our testing to focus on one PFAS from each of
the categories, so that we can be the--as efficient and smart
about getting this information to the Agency as quickly as
possible.
I do know that the Agency doesn't have the resources to
study every single PFAS and fill all of those information gaps
on its own.
Mr. Hudson. I think that is right, and that is another real
challenge. And one of my concerns throughout this whole
process, you know, I worked very closely with my colleagues
across the aisle on this committee to push for this
information. I was thrilled that the administrator--once he
took office.
But if we are not smart about how we target, you know, it
is sort of the old adage, you know, if everything is dangerous,
nothing is dangerous. And, you know, we know that there are
certain of these chemicals that are dangerous. I think we need
to focus on those, because we don't have the capacity to test--
right away within a timely manner.
So I think it is wise that you are--I would just encourage
you, let's target the PFAS that we know are dangerous, that we
know are impacting our communities now, like GenX. I think that
will be important.
Then finally----
[Audio malfunction.]
Mr. Hudson [continue]. GenX was released on Monday--
substantially on animal studies. This assessment we have been
waiting for for a long time. We think it will really help
policymakers and local communities to take action--public
health.
[Audio malfunction.]
Mr. Hudson [continue]. Is going to be communicated to
constituents and citizens living in the Cape Fear Region who
have been impacted by--I am sure--as I am sure you know, the
final--reference doses are substantially lower than previous
assessments.
Can you tell us how the EPA intends to communicate this
risk to North Carolina citizens?
Dr. Freedhoff. I am very sorry, I couldn't--I think the
technology was freezing up a little bit. I--and I didn't
understand what you were asking. I am wondering if any of the
members----
Mr. Hudson. I will try it again. So I was very happy with
the final toxicology assessments finally released--a long time
waiting for them. But they were substantially lower than what
had been previously assessed.
And I guess the crux of my question is, how is the EPA
going to communicate the toxicology level, the threat as we now
understand, to people in North Carolina?
Dr. Freedhoff. I agree completely with you, that
communicating risk to the people who have been affected by
exposure to PFAS and other chemicals is extremely important and
extremely challenging, and I have personally met with a number
of community organizations from North Carolina more than once,
and I hear the frustration and the anger and the fear every
time I talk to them.
And I know there is communities like that all across the
country, and I--it is very important for me, I know for the
administrator, as well, who comes from North Carolina, and
everyone else in the Agency that we really do a better job at
talking to people, and hearing what they have to say, and
explaining the risks that they might have faced in the past.
Mr. Hudson. Thank you----
Mr. Tonko. Thank you. The----
Mr. Hudson [continue]. Mr. Chairman, for your indulgence.
Mr. Tonko. OK, you are welcome. The gentleman yields back.
The Chair now addresses our next colleague, who is logged in
virtually, and that would be the gentlelady from Michigan.
Representative Dingell, you are recognized for 5 minutes,
please.
Mrs. Dingell. Thank you, Mr. Chairman, and thank you for
holding this important oversight hearing on TSCA.
As we are examining these issues, I am going to follow my
Republican colleague and focus on how we address--and thank him
for his efforts and his concern on these issues--on how we
address the harm--contaminants, PFAS chemicals, under this law.
The American people need an EPA that takes the health risk
of PFAS seriously, and acts accordingly. And for years, quite
frankly, the Agency has dragged its feet. That is why the House
passed H.R. 2467, the PFAS Action Act, bipartisan legislation
that I co-authored with Mr. Upton--and Mr. Hudson has been a
great colleague on this, as well as many of my other
colleagues--which needs to take that comprehensive approach to
protecting public health.
You have--the Biden Administration has committed to acting
on the PFAS crisis, including releasing a supportive statement
of Administration policy for the PFAS Action Act, and I still
believe that this legislation is critically necessary to enact.
I also support and want to--EPA for not waiting for the Senate,
which is always a mistake these days----
[Audio malfunction.]
Mrs. Dingell [continue]. Your PFAS strategic roadmap, which
includes concrete actions with timelines across EPA offices to
regulate PFAS. The PFAS Action Act, much like EPA's strategic
roadmap, is based on robust testing regime to build scientific
evidence and define categories of PFAS.
So Administrator Freedhoff, in Michigan we have had an
aggressive testing regime in place for several years now. What
is your plan to implement a national PFAS testing strategy, and
how do you intend to use TSCA's test order authorities?
I know you just said it was going to take a little time,
but you know what? It has been years. So--and how many test
orders--I hope we will see--can we expect to see before the end
of the year?
Dr. Freedhoff. Thanks very much for that question,
Congresswoman, and I just want to say that we very much
appreciate the bipartisan leadership that you and others have
engaged in on putting together your vision of a comprehensive
solution to the PFAS problem. And we really do welcome the
opportunity to work with you, going forward.
We expect to issue the first 20 test orders to companies
who make 20 different PFAS that are in 20 different categories
before the end of this year, as part of our first step in our
PFAS testing strategy. Those test orders are going to focus on
categories about--of PFAS about which we have missing health
risk information, because we think the health risks are the
most important gaps to fill first.
But we want to continue to fill those gaps, and I--and
refine the strategy as we move forward, and as we get more
experience and a deeper understanding of the diversity of
health effects that the classes of chemicals pose.
Mrs. Dingell. Thank you. While the PFAS strategy lays out a
comprehensive approach, this wasn't the first step your office
has taken on PFAS this year. In April EPA announced it would
expect to deny low-volume exemptions under TSCA for PFAS,
moving forward.
Section 5(h)(4) of TSCA allows EPA to exempt chemicals from
pre-manufacture notice review, only if substances will not
present an unreasonable risk of injury to health or the
environment. But given that the best science available
demonstrates that PFAS is very likely, or does present very
likely serious health risks, I don't believe any exemption
should be available to any new PFAS.
Administrator, while I applaud EPA's decision on low-volume
exemptions, does EPA plan to continue allowing PFAS to receive
other types of pre-manufacture notice exemptions?
Dr. Freedhoff. So we--as you said, Congresswoman, we
announced in April that we generally expected to deny low-
volume exemption requests for new PFAS because low-volume
exemption requests don't provide for the same robust safety
review that the 2016 Lautenberg amendments required us to
undertake for other new chemical submissions. I believe there
are other exemptions in Section 5 for--that exist, but I don't
believe those have ever been used for new PFAS. And that was
why our announcement focused very much on the low-volume
exemptions.
I think it is important to note that hundreds of PFAS were
allowed into commerce, in some cases decades ago, before the
Agency really understood what it understands today about PFAS,
and also before the 2016 Lautenberg amendments required EPA to
undertake a robust safety review and impose regulations before
something can enter commerce safely.
And the other thing we are using our TSCA authority for
that we have talked about in the roadmap is we are taking a
backwards look at some of those older decisions that might not
have been as protective as they ought to have been, and doing
everything we can to shore those up for the future.
Mrs. Dingell. Thank you.
I know, Mr. Chairman, I am out of time. I am going to
submit some questions for the record.
[The questions submitted for the record by Mrs. Dingell
follow:]
[The information appears at the conclusion of the hearing.]
Mrs. Dingell. But I would like to ask if we could commit to
working with this--if she, the administrator, would commit to
working with us on the Committee on refining the PFAS Action
Act so ensure it accounts for and aligns with steps being taken
by EPA as part of the PFAS strategic roadmap.
I hope she will say yes to that, and then I will yield
back.
Mr. Tonko. OK, the gentlelady yields back. The Chair now
recognizes Representative Carter. The gentleman from Georgia is
recognized for 5 minutes, please.
Mr. Carter. Thank you, Mr. Chairman, and thank you, Dr.
Freedhoff, for being here. We appreciate your participation
here.
It is my understanding that the 2016 changes to the Toxic
Substances Control Act state that EPA must make a determination
whether the chemical substance presents an unreasonable risk of
injury to health or the environment under the conditions of
use.
It is also my understanding that the law was not intended
to be hazard-based or zero-risk, and that chemicals would be
evaluated using both hazard and exposure. And that has been
mentioned in former Representative John Shimkus's law that he
was the House sponsor of.
But we have heard that there have been these long delays in
evaluating these chemicals, and that it is detrimental to
industry. And it brings about potentially beneficial new
chemicals to commerce--it stops them, and prohibits them from
getting--and certainly, we want to make sure everyone is safe.
But at the same time, we want to remove as many obstacles as we
possibly can. And certainly, with these long delays that we are
hearing about, we are very concerned about that.
How is it that your office is ensuring that chemicals are
evaluated using risk-based criteria, and not going back to a
precautionary hazard-based approach?
Dr. Freedhoff. Thanks very much for that question. I
entirely agree with you, that the law requires a risk-based
approach, and that is--that includes a consideration of both
the hazard and the exposure associated with the conditions of
use. And I do believe that that is what our office undertakes.
Mr. Carter. Well, unreasonable risk, when you say
unreasonable risk, does that mean no risk whatsoever, or very
little risk?
Dr. Freedhoff. It means the--we do a risk assessment, we
describe what we found, and we take steps to address that risk.
I don't think--I think ``unreasonable'' is an adjective,
but it is not synonymous with ``no,'' and it is not synonymous
with ``any.'' It is really--it is what the Agency judges to be
a reasonable----
Mr. Carter. You are sounding like a politician now.
Dr. Freedhoff. I did spend 25 years up here.
Mr. Carter. But--well, let me ask you this, then. Will EPA
allow the use of chemicals given an ``unreasonable'' risk
determination in limited conditions of use?
In other words, if there is just a limited condition where
they could use it, and there is a--there is very little risk,
would EPA consider allowing that?
Dr. Freedhoff. I think we would expect to tailor our risk
management decisions to address the uses that showed the risk.
So if some uses didn't show risks, we would generally expect
that those uses wouldn't be the ones that we would impose the
restrictions on.
Mr. Carter. Well, how do you balance the fact that--so many
of these chemicals--and previously you were asked, just before,
with Representative Dingell, about PFAS, and those, and we have
had a lot of discussion on this committee, on this
subcommittee, in particular, about that class of chemicals. And
as you know, it is over 9,000 it includes.
How do you risk--how do you balance that? Does the risk
outweigh the benefit? Because a lot of them have a tremendous
benefit in our society.
Dr. Freedhoff. I honestly don't believe that we have to
choose between safety and industry. I don't think--I think it
is the same--you know, I think we can do both things.
I think it is possible to use chemicals in a way that
doesn't result in their release to our drinking water or to the
air. And that is the approach that we would be likely to take,
is recognizing the benefits that many chemicals present to all
sectors of society, while also protecting the people from
exposures to those chemicals if they are improperly released.
Mr. Carter. But if there is a total ban, and you can't use
them, then we are not going to get any benefit.
Dr. Freedhoff. I don't think anyone is suggesting that we
are going to ban every single chemical that we evaluate. I
think there will be some that we might propose bans on, there
will be others that we propose fairly minimal occupational
safety measures.
Mr. Carter. Well, you were here for 25 years on this
committee, and in Congress, and you know what--the prevailing
winds, if you will, right now are leading toward a total ban on
PFAS, at least from Congress--from some Members of Congress, I
should say. And that is very concerning, because we have
pointed out during this debate that there are some very
important beneficial uses of these chemicals. Any----
Dr. Freedhoff. I think we are committed to evaluating PFAS,
and addressing the risks that we identify, and that is our
responsibility under the law. It is what the law requires of
us. And we would certainly welcome the opportunity to work with
Congress, as your legislative efforts move through the
legislative process.
Mr. Carter. OK, well, I certainly hope so, because I think
a total ban on a class of chemicals that includes over 9,000
chemicals that have some very beneficial uses--in fact,
essential uses--in our society is somewhat shortsighted.
So thank you, and I yield back.
Mr. Tonko. The gentleman yields back. The Chair now
recognizes our colleague, virtually, who is the gentlelady from
New York--or should I say Brooklyn?
Representative Clarke, you are recognized for 5 minutes,
please.
Ms. Clarke. Thank you very much, Mr. Chairman. Chairman
Tonko, Ranking Member McKinley, thank you for convening this
important hearing on the steps EPA is taking to protect
consumers, workers from toxic chemicals.
And let me also thank our witness, Dr. Freedhoff, for your
testimony.
One dangerous chemical that I would like to focus on today
is methylene chloride, which is a volatile chemical solvent
that can be found in a wide range of commercial and consumer
products, such as paint and coating removal, metal cleaning,
chemical processing, and more. Health impacts from limited
exposure can include confusion, headaches, chest pain, whereas
chronic exposure causes significant damage to the central
nervous system. Acute exposure at high concentrations can even
lead to respiratory failure and death.
From the years 2000 to 2011, a total of 13 Americans died
from acute exposure to methylene chloride while refinishing
bathtubs. The Toxic Substances Control Act requires that EPA
take action to effectively mitigate these risks.
So, Dr. Freedhoff, what is EPA doing to protect Americans
from methylene chloride exposure?
Dr. Freedhoff. Thanks very much for that question,
Congresswoman.
And you know, in my past job I remember meeting with the
families of people whose sons had died from exposure to
methylene chloride, even though they were wearing all the
proper protective equipment, and were fully trained. And you
know, that--the memory of meeting with those families has
really stayed with me.
EPA in the last Administration completed the risk
evaluation for methylene chloride, and finalized a ban only on
the retail uses of that substance. We are now considering the
rest of the uses of methylene chloride, and are working to
ensure that the rule we are considering won't leave communities
and--or fenceline communities with additional exposures that we
might need to address.
And once we have completed our check on that, I would
expect that we will send the proposed rule for the rest of the
uses of methylene chloride for interagency review some time
next year.
Ms. Clarke. Well, I am so glad to hear that you are on the
case, and that EPA continues to regulate this very dangerous
chemical.
In 2017 the Trump EPA proposed banning the use of methylene
chloride as a paint stripper, yet ended up only banning its
consumer uses. This left workers who come into frequent contact
with this chemical exposed, despite the known risk to their
health.
Dr. Freedhoff, is methylene chloride any less harmful in
commercial applications as it is in consumer uses?
Dr. Freedhoff. Yes, our proposed rule that will also
address the commercial uses is the effort that I was referring
to earlier, and we do expect to send that proposed rule for
interagency review some time next year.
Ms. Clarke. And how is EPA going to ensure that workers are
just as protected from methylene chloride exposure as non-
commercial consumers are?
Dr. Freedhoff. We have actually reversed the previous
Administration's policy decision to assume that workers are
always properly protected and have protective gear. And as I
mentioned, with methylene chloride, the workers who had the
protective gear still were poisoned, and died from exposure to
those chemicals.
So I think the worker--the occupational risks associated
with methylene chloride exposure are very much front of mind
for us, and we will be ensuring that those risks are understood
and addressed in the rule that we propose.
Ms. Clarke. Well, it is critical that the chemical
regulatory process does not exclude vulnerable populations,
including workers who frequently handle this very dangerous
chemical.
Let me thank you for your time and attention to this
matter.
And Mr. Chairman, I yield back the balance of my time.
[Pause.]
Ms. Clarke. Mr. Chairman?
[No response.]
Ms. Clarke. I yield back, Mr. Chairman.
Mr. Soto [presiding]. Thank you so much. The Chair now
recognizes Representative Palmer for 5 minutes.
Mr. Palmer. I thank the chairman. I thank the witnesses for
being here. I want to follow up on an issue raised by
Representative Schakowsky about animal testing.
In 2018 EPA published its strategic plan to promote
development and implementation of alternative test methods
within the TSCA program, including an initial list of
alternative test methods and strategies for new approach
methodologies. And I think all of us have heard a good bit
lately about the testing being done involving the beagle
puppies. We have this picture that, I think, has gone around
nationally.
[Slide]
Mr. Palmer. While I understand that there is different
agency protocols here, whether it is National Institute for
Health or others, EPA--can we be assured that the EPA would not
allow barbaric experiments on animals, such as we see with
these beagle puppies, where they were literally eaten alive by
sandflies?
Dr. Freedhoff. I hadn't previously seen those images. I am
thinking of my own dog and cat right now, and--you know, I
think----
Mr. Palmer. It is shocking, isn't it?
Dr. Freedhoff. It really is.
Mr. Palmer. It is heartbreaking. Well, that is--this is all
in the news right now, what is going on there. I just want to
be sure that the EPA, in these new approach methodologies, will
ensure that we don't impose that type of suffering. Apparently,
they slit the beagles' vocal cords, so they couldn't hear them
barking.
I do have some other questions more relevant to the EPA. In
the lead-up to the hearing, I heard from many manufacturers and
groups that feel that, once they submit a new chemical for
review, it just disappears into a black hole. And what they
want to know is do you currently have plans to make this
process more transparent, and improve the communication between
the Agency and industry?
Dr. Freedhoff. Thanks very much for that question. I was
actually surprised, when I first started at the Agency, at the
frustration from all stakeholders, not just environmental
organizations, but also from industry stakeholders that I have
worked with for years, at the level of engagement on--as TSCA
was implemented over the past few years. And I have tried
really hard to improve that. I have met with industry
frequently, I have met with environmental organizations
frequently. I think that our work is only better when we get
input from stakeholders and consider it.
Mr. Palmer. If you have some plans for improving this
process, would you submit them to the committee? I would like
to see that.
Dr. Freedhoff. Absolutely.
Mr. Palmer. I think it would help us in communication--
communicating with outside groups.
During the pandemic, the FDA released industry guidance
that clearly--about types of testing data that they would want
to see from any group trying to develop vaccines and
therapeutics. This helped speed up the review process, as
industry didn't waste time and effort collecting data that was
not relevant.
I am--we are also hearing that a lot of the folks in the
industry feel like they are wasting time and effort collecting
data that the EPA doesn't end up using in its new chemical
reviews. And what, again, we are hearing is--do you have plans
to publish a single document, so that manufacturers that you
ask to get data from--give them clearly what you expect, in
terms of the exact data you need, without wasting everybody's
time and their money collecting data that doesn't get used?
And I think you can understand the frustration that folks
from the industry side feel in this regard, that there is a
lack of transparency, and then a lack of seriousness about the
use of the data that you have asked them to collect.
Dr. Freedhoff. I agree that we could do a better job both
at conveying our expectations to industry before they send us a
new chemical submittal, so they know what we expect, and that
will speed their approval process along. And so it is in their
interests and our interests to get that information earlier.
And I also think that we could be smarter about our data
collection. So one rule that we are considering proposing is a
way to add information requests when we need it, and take the
information requests away when we don't need it. And that is
something that we had a public meeting about, got industry and
other stakeholder input to our ideas, and are now busy
translating those ideas into a proposed rule.
Mr. Palmer. Well, again, going back to what I asked you to
provide the committee, I would appreciate it if you would do
that.
And also, I think, again, looking at this photo, it would
be good if we got some assurances from the EPA in regard to
animal testing, that we wouldn't allow anything like that.
Mr. Chairman, I yield back.
Mr. Soto. The gentleman's time has expired. The Chair now
recognizes Representative Sarbanes for 5 minutes.
Mr. Sarbanes. Thanks very much, Mr. Chairman. I appreciate
the hearing.
I want to thank you, Dr. Freedhoff, for joining us today.
You have got a really critical task in administering TSCA, and
guarding the health and safety of our citizens around the
country.
I am certainly a long supporter of upgrading and
modernizing our chemical safety laws to provide these needed
protections to Americans. And the Lautenberg Act, the upgraded
version of TSCA, contained very positive reforms.
I myself had some anxiety around the issue of pause
preemption, which allows the Federal Government, frankly, to
block states from regulating these harmful chemicals by simply
proposing to study them. And the danger is that could lead to
years in which a state is, essentially, stopped from regulating
dangerous chemicals, if the EPA hasn't yet acted. There was
some grandfathering. I wanted to talk to you a little bit about
this issue.
So the pause preemption did not apply for the first ten
chemicals that EPA evaluated under the Lautenberg Act. Is that
correct?
Dr. Freedhoff. Yes, that is correct.
Mr. Sarbanes. And then, nevertheless, for its subsequent
chemicals, including those that were designated as, ``high
priority,'' the pause preemption would apply. Is that right?
Dr. Freedhoff. Yes, it is.
Mr. Sarbanes. So that is a concern to me, particularly for
chemicals like PFAS, which has gotten a lot of discussion
today, because states have been active there, in trying to
implement policies to protect public health when the Federal
action has been lacking, and the pause preemption provision
could leave communities unprotected, which could continue to
expose Americans, obviously, including our most vulnerable.
In your view, does the pause preemption provision help,
hinder?
How does it affect the goal of consistent and effective
regulation to keep the public and our environment safe from
these chemicals that pose a risk?
Dr. Freedhoff. Thanks very much for that question. As you
probably know, the preemption provisions of TSCA were among the
very last provisions to be resolved in the negotiations.
I guess I would, first of all, say that I think this
Administration views its relationship with its state regulators
differently than the previous Administration. We think of
states who lead, not just on chemical safety, but also on
things like vehicle emissions, as our partners and not our
adversaries. So I do think that we want to be constructive
partners with state regulators, rather than looking to block
their efforts.
I am not currently aware of a state whose efforts will be
paused as part of our next 20 risk--chemicals that are
undergoing risk evaluations, but that doesn't mean that those
efforts don't exist. I am just not personally aware of them.
And I do think the law provides some opportunity for states to
ask EPA for waivers from preemption in cases where the actions
that they have taken precede the Agency's designation of the
substance as a high priority one for evaluation, and will
certainly be considering any requests we get like that very
seriously.
Mr. Sarbanes. I appreciate that answer, it was very
diplomatic. I certainly appreciate that it is on Congress to
fix this problem of the pause preemption, and I certainly also
appreciate that the Biden Administration is likely to be more
aligned and in sync with states that are trying to be on the
leading edge when it comes to regulating these toxic chemicals.
So it may be that, in this instance, the potential for
there to be dissonance there is less. However, my own view is
that we need to make a change with respect to that pause
preemption, and make sure that whoever is going to be on the
leading edge of addressing these toxic chemicals has the
flexibility to do that, to exercise that leadership that is
coming from the state. The mere study of a chemical by the
Federal Government should not operate to frustrate those state
level efforts.
So we will continue to focus on that. I very much
appreciate your testimony, and thank you for your good work at
the Agency.
And with that I yield back.
Mr. Soto. The gentleman's time has expired. Representative
Curtis is recognized for 5 minutes.
Mr. Curtis. Thank you very much, Mr. Chairman. I find
myself smiling because we may actually be--I might be following
a Democrat arguing for preemption when I would be supporting
the preemption. Excuse me, him arguing against, and me arguing
for it. Kind of an unusual position for Republicans and
Democrats.
But I am--I put on a former mayor's hat, and generally
don't like to see the Federal Government intervene in what we
are doing in states and in cities. But I personally feel that
one state, especially when using non-widely-accepted science,
shouldn't use their market power and their legal system to
force regulations on other governments, or place companies in a
position of complying with that choice of complying or just
leaving the state.
I also put on a hat, Madam Administrator, as a former
business owner, and would say I think what business owners fear
worse than regulation is uncertainty, or slow decision-making.
So my first question for you is, how do you plan to execute
your decisions in a way that permits industry time to respond,
in a way that meets the needs of their consumers, and, you
could say, actually, their investors and shareholders, as well?
Dr. Freedhoff. Thanks very much for that question, and I
agree that predictable, transparent, and regular order is what
TSCA implementation needs. And we are working to improve our
communications, we are working to improve our engagement with
stakeholders, we are working to answer industry questions when
they have them, and improve our processes whenever we can. And
I very much welcome suggestions for, you know, things you think
we could be doing better if we miss the mark.
Mr. Curtis. Yes, and I don't have specific suggestions,
other than predictability, right?
And I think businesses learn to adapt to almost any
government regulation. But what is really hard on them is the
unpredictable nature, sometimes, of government regulations.
Coming back to this preemption issue, the perfect answer is
to make states feel like they don't need their own regulations.
Can you talk about your approach to making states comfortable,
so they don't feel like they need to do any regulation on----
Dr. Freedhoff. Thanks, Congressman. You have actually hit
on the exact reason why Congress was able to land on a
preemption compromise when we negotiated the reforms to TSCA.
And the idea was, if you had a credible and strong Federal
regulation, states wouldn't need or feel like they wanted to
spend their own precious resources addressing something that
the Federal Government had already addressed.
And that is why it is so important that, when the Agency
says that a chemical can be used safely, that everyone believes
that we have made that judgment using the best available
science, and written a rule that is as protective as it needs
to be.
Mr. Curtis. Thank you. Are you aware of any states
currently considering action against a chemical that you would
currently be evaluating in your office?
Dr. Freedhoff. I am sorry, I didn't catch that question.
Mr. Curtis. Yes, are you aware of any states out there that
might be considering state action against a chemical that is
currently under evaluation by your office?
Dr. Freedhoff. I am not aware of pending state actions on
the next 20 substances that we are doing risk evaluations on.
But that doesn't mean there aren't any that are being planned;
I just might not be aware of them.
Mr. Curtis. And kind of the opposite question: is the EPA
considering acting on any chemicals that would create national
standards, and cause preemption from state--current state
regulations?
Dr. Freedhoff. I think that EPA would be--we would--we are
moving forward to set Federal chemical safety regulations, and
would certainly implement any authorities we have related to
the preemption that flows from those decisions.
Mr. Curtis. Yes, I--and that is good. Are there any
specifics that come to mind right now that you would think
would evoke preemption?
Dr. Freedhoff. No, and that is because the first pause
preemption didn't apply to the first ten chemicals that
underwent risk evaluation, and we haven't yet written rules
about those chemicals, which triggers different preemption
provisions. So it is a--at this point, it is largely a
hypothetical question about, you know, about what would happen,
once a Federal regulation was in place for a substance.
Mr. Curtis. Excellent. Thank you very much for your
answers.
Mr. Chairman, I am out of time, and I yield back.
Mr. Soto. The gentleman yields back. The Chair now
recognizes Representative Peters for 5 minutes.
Mr. Peters. Thank you, Mr. Chairman. I actually wanted to
greet the administrator with the notation that I am a former
EPA Office of Toxic Substances employee. I worked there in the
1980s, when this was a difficult Act to administer, and was
often frustrating, so I am happy for the Lautenberg Act and the
clarifications.
That bill included a direct path to risk management
regulation for a small subset of chemical substances that have
been identified as persistent, bio-accumulative, and toxic,
PBT, and that was a significant step forward in the reform of
TSCA.
The previous Administration issued final rules that went
into effect in February of this year. But in light of executive
orders and guidance, EPA announced in March it was re-reviewing
these rules, and considering revising all of the final rules
completed out of the last Administration.
So Dr. Freedhoff, what did the Agency find during the
public comment period that led to reevaluating the final rules?
Dr. Freedhoff. We are still in the process of looking at
all of the comments that we received during that public comment
period that--you know, there was one portion of one of those
five rules that a large number of industry sectors came to us
with serious supply chain disruption concerns about, very early
in the Biden Administration. Of course, these rules were
finalized in the previous Administration, and the industries
had somehow failed to recognize or understand what EPA was
proposing, and didn't communicate with the previous
Administration at that time.
We think, as part of our re-examination of a lot of the
different policies that were put into place by the last
Administration, that there may well be ways to strengthen each
of those five rules. And we are looking at opportunities like
that at the same time as we are looking at addressing the
supply chain disruption challenges that industry stakeholders
raised about one of those five chemicals.
Mr. Peters. Great.
Dr. Freedhoff. And I would expect that we will propose some
changes for all--you know, for as many as all five of the
chemicals some time in the coming one to two years.
Mr. Peters. And maybe this gets to that, because your
office moved to extend the compliance date for one of the PBT
chemicals, PIP (3:1), until October 31st of 2024. But I know
you have supply chain concerns, and there is downstream
impacts.
I do have concerns that giving extensions to processors and
distributors who fail to engage on public rulemakings may not
be consistent with the intent of the TSCA reform. Can you
explain why PIP (3:1) was given an extension?
Dr. Freedhoff. So I think what happened when the Trump
Administration proposed that phase-out of PIP (3:1) is that,
despite their efforts to reach out to companies, hold webinars,
issue press releases, have--you know, have meetings with
industry stakeholders, none of those industries came to the
Agency with their concerns until after the rule was finalized.
And by the time that happened, they were concerned that
everything, from phone chargers to tractors to cars to all
kinds of other electronic equipment, might have that substance
in the supply chain. And then they--and they had not made the
efforts that they should have made earlier to find out what
those chemicals were being used for, and make specific
arguments to the Agency about why an extension was necessary.
Nevertheless, it seemed like such a wide portion of the
economy might be impacted if we didn't take some interim
measures to extend the compliance date for just that one part
of the rule, that----
Mr. Peters. Do you anticipate other extensions for PBTs in
the TSCA----
Dr. Freedhoff. I am sorry, I didn't hear that.
Mr. Peters. Do you anticipate any other extensions for PBTs
in the TSCA work plan?
Dr. Freedhoff. I am sorry, you are--it is hard to
understand----
Mr. Peters. I am sorry.
Dr. Freedhoff [continue]. Over--with this connection. Could
you try one more time?
Mr. Peters. Do you anticipate any other extensions for
PBTs----
Dr. Freedhoff. Oh, I see, I am sorry.
We did just propose an additional extension. And what we
have said to industry stakeholders--and I would welcome your
help in conveying this message, as well--is that if we are
going to propose any additional extensions, we need specific,
scientifically and legally defensible reasons why they might
need that.
So an example of a need for----
Mr. Peters. Well, I am about to run out of time, so I just
want to say that I just--we don't want to set a precedent for
extending compliance for industries that don't chime in at the
right time, and fail to identify their chemicals, and notify
the EPA during the comment period. So I hope you will do
outreach that helps companies make sure that they are
participating, so we don't get short-circuited again like this.
And I appreciate--I yield back, Mr. Chair.
Mr. Soto. The gentleman yields back. Representative
Crenshaw is now recognized for 5 minutes.
Mr. Crenshaw. Thank you, Mr. Chairman and thank you, Ms.
Freedhoff, for being here today.
So I want to get back to a question I think you have been
asked before, which is defining unreasonable risk. You alluded
to this with Representative Carter. You mentioned that
``unreasonable'' is an adjective. But ``unreasonable risk'' is
a term that has been described by the courts in case law.
So I am wondering if you can tell us again, for
clarification, what--how you would define that at your Agency,
because that is important, going forward.
Dr. Freedhoff. I am not sure that there is any single
definition of ``unreasonable risk,'' Congressman. And I think,
speaking as someone who tried to come up with a definition when
we negotiated the law, it was clear that others didn't believe
that there was a precise definition, either.
And what the law--what the reform law asked us to do was
evaluate the chemical across all of the conditions of use that
are reasonably foreseeable and known to the Administration, and
come up with a risk evaluation that addresses that--that
describes that risk.
Then, when we think about what regulations we might need to
put into place, we are required by law to consider things like
costs to industry, and whether the chemical is used for a
critical economic or military need. And we are certainly
expecting to take that--to take those considerations into
account when we move into the rulemaking phase.
Mr. Crenshaw. And maybe that was a bad way to write the
law, then. And--but I think we owe it to industry, I think we
owe it to ourselves to have a much more clear definition of
what ``unreasonable risk'' might be, if we are going to do risk
evaluations that have to be compared against some kind of
standard.
You mentioned innovation, and it brings me to my next
question. How do you plan on meeting statutory deadlines under
TSCA, without deterring or slowing innovation? How can your
office do that?
Dr. Freedhoff. As I said earlier in my testimony, the
Agency is currently operating with less than 50 percent of the
resources that it thinks it needs to operate the new chemicals
program in the way that Congress intended. And Congress
intended for us to assess the chemicals, and to decide what to
do about them in a quick time frame.
I personally don't believe that innovation and safety are
mutually exclusive, and I really want to work with Congress,
and work with the excellent career staff at the Agency to
improve in all areas of our implementation plans.
Mr. Crenshaw. My next question is regarding greenhouse
gases. The EPA has been giving--been given quite a few
resources to explore standards for greenhouse gases across a
half-dozen programs under the Clean Air Act. Do you think EPA
can regulate greenhouse gases as a chemical substance under
TSCA?
Dr. Freedhoff. It is not a question that I have thought
about. I think I would like to answer for the record, if that
is OK with you. I would like to provide a more----
Mr. Crenshaw. Sure. Well, Section 9 of TSCA prohibits TSCA
from regulating that. The reason I ask is because groups are
trying to get you to regulate that. And we would like your
assurances that you will follow the law under Section 9 of TSCA
that says that has to be regulated under the Clean Air Act.
Dr. Freedhoff. We will definitely be following the law, and
looking to Section 9 to guide our decision-making.
Mr. Crenshaw. OK, I appreciate that, and I yield back.
Mr. Soto. The gentleman yields back. The Chair now
recognizes Representative Barragan for 5 minutes.
Ms. Barragan. Thank you, Mr. Chairman.
Dr. Freedhoff, when Congress updated the Toxic Substances
Control Act in 2016, one new provision requires EPA to account
for potentially exposed and susceptible sub-populations in its
assessment of whether the use of a chemical substance presents
an unreasonable risk to health or the environment.
How will your office use this provision to protect
environmental justice communities close to facilities that
release toxic chemicals into the environment?
Dr. Freedhoff. Thanks very much for that question,
Congresswoman. You know, the previous Administration decided to
exclude air, water, and disposal exposures from even being
considered under the risk evaluations. And what that
essentially meant is that they said that, for purposes of TSCA,
it doesn't count if you drink it, and it doesn't count if you
breathe it. And we don't think that was the right approach, and
we do plan--and we have reversed that policy decision.
One thing that we are doing in order to better understand
whether those risk evaluations that were finished by the
previous Administration exclude exposures like the ones you are
talking about, is develop a fenceline screening methodology.
And that methodology is intended to do a quick look at
fenceline communities who might be disproportionately exposed
to these chemicals, to be sure that the risk management actions
that we are thinking about actually address the risks that
these communities pose.
And I expect that we will be releasing that methodology for
both peer review and public comment later this year.
Ms. Barragan. Great, thank you. The PFAS roadmap that EPA
recently released includes a commitment to re-examine previous
decisions to allow new PFAS into commerce. In July the New York
Times reported that, in 2011, the EPA approved three chemicals
for fracking, despite concerns by Agency scientists the
chemicals have the potential to break down to PFAS, which
threatens workers, human health, and our environment.
Will the EPA revisit the chemicals it has approved for
fracking as part of its review of previous decisions on past
approvals?
Dr. Freedhoff. Thanks very much for that question. And we
actually have been taking a backwards look at all of our
previous PFAS decisions, because it is--you know, there were a
number that were approved in the 1980s, before the Agency
really understands what it currently does about those
chemicals. And we think all of them need to be looked at again.
We are in the process of doing that, and I imagine that we
will have some results to share in the coming months.
Ms. Barragan. Well, thank you for that, because, you know,
ten years ago the Agency scientists identified serious health
risks to these chemicals, and yet they approved them, anyhow. I
believe we must do better, and now is an opportunity to correct
that mistake.
Next, for many years we have recognized the need to address
cumulative impacts of pollution on communities exposed to
unsafe levels of air and water pollution from multiple sources.
It is also critical EPA consider cumulative impacts when
assessing cumulative chemical exposures, where a community
could be impacted by more than one chemical or a mixture of
chemicals. This can worsen the effects of exposure to the
chemical being evaluated.
Will your office use the Toxic Substances Control Act to
advance the cumulative risk assessment of chemicals?
Dr. Freedhoff. Thanks very much for that. It is, actually,
a very, very difficult problem, scientifically. And the entire
Agency is working together on ways that we can better
understand the cumulative effects, and ultimately on ways that
we might be able to include cumulative effect considerations in
our risk management rules.
I think the fenceline community methodology that I was
describing to you earlier is just a first step of what we are
looking at to try to understand and address the
disproportionate exposures to pollution that some communities
have faced, in some cases, for decades. And I look forward to
keeping the committee informed of these efforts, as we move
forward.
Ms. Barragan. Well, thank you, Doctor, for your testimony.
And I just want to continue to encourage you to look at these
cumulative impacts, and I know it can be challenging, but when
we are looking in a vacuum at approvals for one chemical in a
vacuum, it doesn't really tell you in whole what it is doing to
communities. And I do think that is important in the long term.
So thank you for your service and your testimony today.
With that, Mr. Chairman, I yield back.
Mr. Soto. The gentlelady yields back. The Chair now
recognizes Representative Blunt Rochester for 5 minutes.
Ms. Blunt Rochester. Thank you, Mr. Chairman and Ranking
Member McKinley, for calling this important hearing, and
welcome back, Dr. Freedhoff, and thank you for being here to
discuss the EPA's efforts to fully implement the 2016
amendments to the Toxic Substance Control Act.
These bipartisan amendments were an important step toward
reforming the Federal Government's approach to chemical safety
to better protect human health and the environment from the
impacts of chemical pollution. It has been five years since the
Lautenberg Act passed, and we need to ensure that what was
passed is executed.
As a Delawarean, I know the importance of chemical safety,
from the health and safety of the workers at the chemical
plants in my state and their neighboring communities, to the
families that use everyday household items with chemicals. We
need to work together to ensure that all Americans are safe
from chemical harm, and that science, transparency, and equity
are at the center of EPA's decisions.
Dr. Freedhoff, as you know, Delaware is home to some of
America's leading chemical companies. How will implementation
of these TSCA amendments ultimately benefit them, as well as
the general public?
Dr. Freedhoff. I actually think that one of the reasons why
many of those companies supported TSCA reform--didn't just
support it, but encouraged it--was because they fundamentally
knew that, if the public believed that when EPA said that a
chemical was--can be safely used, it can be safely used. And I
think the more credible a presence the Agency has in
understanding and addressing the risks from chemicals, the more
the public will also accept and trust the products that
industry makes.
Ms. Blunt Rochester. Thank you for that. I think you use
the word ``confidence'' earlier in your testimony, that it
gives people confidence.
As a follow-up to Representative Barragan question, I am
particularly concerned with the impacts of chemical exposure on
environmental justice communities, who are already
disproportionately impacted by legacy pollution.
As you stated, under the last Administration the first ten
chemical risk evaluations under TSCA neglected to address the
impacts of exposure from air, water, or disposal to the general
population, because it was falsely assumed that other statutes
would address those exposures. This approach failed to protect
our most vulnerable populations from dangerous chemicals, and I
was encouraged to hear of your office's plan to re-examine some
of these chemicals to assess whether the exclusion of exposures
from air, water, and disposal disproportionately harm
environmental justice communities.
Dr. Freedhoff, why is it important for EPA to supplement
its risk evaluations with an environmental justice lens?
Dr. Freedhoff. I think what we all have realized, I mean,
not just in the past few months, but over many years, is that
there are some communities who have been disproportionately
exposed to multiple chemicals for generations. And that is
evidenced by the health of those communities. It is evidenced
in so many ways, whether it is lead in paint, or exposures to
ethylene oxide releases, or PFAS, or being located near
landfills that were built decades ago, without appropriate
protections. We are talking about generations of exposure.
And I do think it is vitally important that TSCA do what
Congress told--said the law should do, which is to protect
potentially exposed and susceptible sub-populations from
unreasonable risks and exposures to chemicals.
Ms. Blunt Rochester. Thank you. And earlier this year EPA
invited EJ stakeholders to participate in environmental justice
consultation for the development of risk management plans for
evaluated chemicals. How is EPA utilizing the information that
these stakeholders are sharing?
And how will you continue to incorporate environmental
justice communities and other stakeholders into risk management
plans?
Dr. Freedhoff. Thanks very much for that. I have met with
some environmental justice community organizations, and will
continue to. And we do these consultations for all of our
risk--our rulemakings under TSCA, and really do value the input
that we get.
We would also really welcome ideas from you or others about
ways we can reach more communities, and talk directly with
communities that are impacted, because I feel like, a lot of
the time, we hear from--we hear more from national
organizations, and I think it is really important that the
Agency understand how their proposed rules might be impacting
the actual people in these communities. So any suggestions you
have for us would be very welcome.
Ms. Blunt Rochester. Thank you, Doctor. We look forward to
working with you, and it is good to see you in this position.
Good luck in all the work that you are embarking on.
And I yield back.
Mr. Soto. The gentlelady yields back. The Chair now
recognizes himself for 5 minutes.
First, Dr. Freedhoff, thank you for what you do to help
regulate chemicals that can, literally, kill our fellow
Americans, if not kept in check. So we want you to take the
time, as you are doing, to get these protections right,
whatever time that takes that is supported by the science.
In Florida, several years ago, we witnessed a cancer
cluster affecting firefighters at the Florida State Fire
College. Our heroes' lives were put in jeopardy because of
unregulated PFAS fire extinguishing chemicals. As many as 27 of
Florida's firefighter training facilities may have been
affected by these toxic chemicals.
As you know, legislation was passed by the House already to
set a national drinking water standard for PFAS, and direct the
EPA on developing discharge limits. We appreciate
Representative Dingell's leadership, and hope the Senate will
follow suit.
And we also applaud you all at EPA for announcing a
comprehensive strategic roadmap to confront PFAS contamination
nationwide under your existing statutory authority, including
the three guiding strategies of increasing investment research,
leveraging authorities to take action to restrict PFAS
chemicals from being released into the environment, and, of
course, accelerating cleanup of PFAS contamination. This is
important for Florida, for my constituents, and for others.
Dr. Freedhoff, how do you see your office's work on testing
and review for PFAS informing the efforts of your colleagues in
other areas of the EPA?
Dr. Freedhoff. Thanks very much for that question, because,
of course, you know, we are proposing regulations on just a
handful of the thousands of PFAS that have historically been
made or used.
And one of the reasons for that is because, if we can't
understand the health effects that the chemicals might pose, we
also can't know what the safe drinking water level would be, or
how much of it you need to clean up.
And so one of the things that we are really excited about
for our testing strategy is that, instead of continuing this
one-by-one-by-one approach, which would take the Agency decades
to finish, we are instead working a little smarter, and sorting
PFAS that have similar properties into subcategories, and
testing representative PFAS from each of those categories.
So our first 20 test orders that will go to 20 different
PFAS manufacturers will actually give us information that we
can extrapolate to 2,000 of those many thousands of chemicals
that have historically been made. And I think that will give us
a real jumpstart on a more comprehensive research, monitoring,
and regulatory plan to address the rest of the substances.
Mr. Soto. So you are categorizing these forever PFAS
chemicals, and building a foundation for other parts of the EPA
Agency, so we appreciate that.
Dr. Freedhoff, how will you, your office, use the expanded
TRI reporting data to further regulatory efforts?
Dr. Freedhoff. So we have implemented the language that
Congress wrote in the 2020 National Defense Authorization Act,
and that language required the immediate addition of almost 200
PFAS to toxic release inventory reporting requirements. And we
are continuing to add PFAS to that list, in accordance with the
direction that Congress provided us.
We also are looking at ways to expand our--the data that we
get from those releases, because we noticed in this first year
of reporting that we got much less from--by way of data than we
expected. And we are trying to understand and address the
reasons for that.
Mr. Soto. Of course. And can you talk a little bit more
about the resources you estimate you will need to implement
your responsibilities under the reformed TSCA?
Dr. Freedhoff. Well, thanks very much for that question.
I--it really does continue to shock me, that the previous
Administration never asked for any additional funds, even
though Congress clearly expected the Agency to have much more
work to do.
And so I think our--the President's fiscal year 2022 budget
gives us the authority to hire about 90 additional full-time
employees. I think that is an excellent downpayment on what it
is that we need to do. But I think, in order to fully realize
the promise of TSCA, which includes robust safety measures, but
also rapid and predictable decision-making, and meeting
statutory deadlines the industry expects us to meet, I think we
will continue to need to work with Congress to build on those
efforts.
Mr. Soto. And so how is your office quantifying costs of
implementing TSCA and envisioning service fees to address
shortcomings?
Dr. Freedhoff. I am sorry, I missed that.
Mr. Soto. How is your office quantifying costs of
implementing the new TSCA?
And how do you envision your office amending the service
fees to address any shortcomings?
Dr. Freedhoff. I actually think we have a report due to
Congress at the end of this year that asks us that very
question. And, you know, part of what we have been doing since
I arrived at the Agency is, first of all, understanding the
costs, but also then recognizing that some of these policy
reversals change the cost considerations, as well, as do the
complexities associated with some of the work that we didn't
previously anticipate.
So I actually really look forward to giving Congress a very
fulsome answer to that question later this year.
Mr. Soto. Thank you. And my time has expired.
I request unanimous consent to enter the following
documents into the record: a letter from Chairman Pallone,
Chair DeGette, Chair Tonko to EPA Administrator Regan; a
response letter from Assistant Administrator Freedhoff to
Chairman Pallone and Chair DeGette and Chairman Tonko,
including six enclosures; a letter from the Household and
Commercial Products Association; and an article from Bloomberg
Law entitled, ``EPA's Chemicals Head Tells Staff to Consider
Work-Life Balance.''
Without objection, so ordered.
I would like to thank our witness, Dr. Freedhoff, for your
patience and candor, and joining us for today's hearing.
I remind Members that, pursuant to committee rules, they
have ten business days to submit additional questions for the
record to be answered by our witness.
I ask that our witness respond promptly to such questions
that you may receive.
At this time, the subcommittee is adjourned.
[Whereupon, at 12:45 p.m., the subcommittee was adjourned.]
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