[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
TESTING OF CHEMICALS AND REPORTING AND RETENTION OF INFORMATION UNDER
TSCA SECTIONS 4 AND 8
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON ENVIRONMENT AND THE ECONOMY
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
SECOND SESSION
__________
FEBRUARY 4, 2014
__________
Serial No. 113-114
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
__________
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas HENRY A. WAXMAN, California
JOE BARTON, Texas Ranking Member
Chairman Emeritus JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky FRANK PALLONE, Jr., New Jersey
JOHN SHIMKUS, Illinois BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania ANNA G. ESHOO, California
GREG WALDEN, Oregon ELIOT L. ENGEL, New York
LEE TERRY, Nebraska GENE GREEN, Texas
MIKE ROGERS, Michigan DIANA DeGETTE, Colorado
TIM MURPHY, Pennsylvania LOIS CAPPS, California
MICHAEL C. BURGESS, Texas MICHAEL F. DOYLE, Pennsylvania
MARSHA BLACKBURN, Tennessee JANICE D. SCHAKOWSKY, Illinois
Vice Chairman JIM MATHESON, Utah
PHIL GINGREY, Georgia G.K. BUTTERFIELD, North Carolina
STEVE SCALISE, Louisiana JOHN BARROW, Georgia
ROBERT E. LATTA, Ohio DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington DONNA M. CHRISTENSEN, Virgin
GREGG HARPER, Mississippi Islands
LEONARD LANCE, New Jersey KATHY CASTOR, Florida
BILL CASSIDY, Louisiana JOHN P. SARBANES, Maryland
BRETT GUTHRIE, Kentucky JERRY McNERNEY, California
PETE OLSON, Texas BRUCE L. BRALEY, Iowa
DAVID B. McKINLEY, West Virginia PETER WELCH, Vermont
CORY GARDNER, Colorado BEN RAY LUJAN, New Mexico
MIKE POMPEO, Kansas PAUL TONKO, New York
ADAM KINZINGER, Illinois JOHN A. YARMUTH, Kentucky
H. MORGAN GRIFFITH, Virginia
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Ohio
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
_____
Subcommittee on Environment and the Economy
JOHN SHIMKUS, Illinois
Chairman
PHIL GINGREY, Georgia PAUL TONKO, New York
Vice Chairman Ranking Member
RALPH M. HALL, Texas FRANK PALLONE, Jr., New Jersey
ED WHITFIELD, Kentucky GENE GREEN, Texas
JOSEPH R. PITTS, Pennsylvania DIANA DeGETTE, Colorado
TIM MURPHY, Pennsylvania LOIS CAPPS, California
ROBERT E. LATTA, Ohio JERRY McNERNEY, California
GREGG HARPER, Mississippi JOHN D. DINGELL, Michigan
BILL CASSIDY, Louisiana JANICE D. SCHAKOWSKY, Illinois
DAVID B. McKINLEY, West Virginia JOHN BARROW, Georgia
GUS M. BILIRAKIS, Florida DORIS O. MATSUI, California
BILL JOHNSON, Ohio HENRY A. WAXMAN, California (ex
JOE BARTON, Texas officio)
FRED UPTON, Michigan (ex officio)
(ii)
C O N T E N T S
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Page
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement.................................... 1
Prepared statement........................................... 2
Hon. Paul Tonko, a Representative in Congress from the State of
New York, opening statement.................................... 3
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, opening statement.................................... 4
Prepared statement........................................... 5
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 6
Witnesses
Charles T. Drevna, President, American Fuel & Petrochemical
Manufacturers.................................................. 7
Prepared statement........................................... 10
Robert A. Matthews, McKenna, Long & Aldridge, LLP, on Behalf of
the Consumer Specialty Products Association.................... 16
Prepared statement........................................... 18
Brent Grazman, Vice President, Quality Assurance, Viasystems
Group, Inc., on Behalf of IPC--The Association Connecting
Electronics Industries......................................... 28
Prepared statement........................................... 30
Beth D. Bosley, President, Boron Specialties, on Behalf of the
Society of Chemical Manufacturers and Affiliates............... 40
Prepared statement........................................... 42
Catherine Willett, Director, Regulatory Toxicology, Risk
Assessment, and Alternatives, The Humane Society of the United
States......................................................... 47
Prepared statement........................................... 49
Jennifer Sass, Senior Scientist, Natural Resources Defense
Council........................................................ 63
Prepared statement........................................... 65
Jerome Paulson, Chairperson, Executive Committee of the Council
on Environmental Health, American Academy of Pediatrics........ 78
Prepared statement........................................... 80
TESTING OF CHEMICALS AND REPORTING AND RETENTION OF INFORMATION UNDER
TSCA SECTIONS 4 AND 8
----------
TUESDAY, FEBRUARY 4, 2014
House of Representatives,
Subcommittee on Environment and the Economy,
Committee on Energy and Commerce,
Washington, DC.
The subcommittee met, pursuant to call, at 10:03 a.m., in
room 2123 of the Rayburn House Office Building, Hon. John
Shimkus (chairman of the subcommittee) presiding.
Members present: Representatives Shimkus, Pitts, Murphy,
Latta, Harper, McKinley, Bilirakis, Johnson, Barton, Upton (ex
officio), Tonko, Green, DeGette, McNerney, Schakowsky, Barrow,
Matsui, and Waxman (ex officio).
Staff present: Nick Abraham, Legislative Clerk; Gary
Andres, Staff Director; Charlotte Baker, Press Secretary; Sean
Bonyun, Communications Director; Jerry Couri, Senior
Environmental Policy Advisor; David McCarthy, Chief Counsel,
Environment and the Economy; Brandon Mooney, Professional Staff
Member; Chris Sarley, Policy Coordinator, Environment and the
Economy; Alison Cassady, Democratic Senior Professional Staff
Member; Greg Dotson, Democratic Staff Director, Energy and the
Environment; Caitlin Haberman, Democratic Policy Analyst; and
Elizabeth Letter, Democratic Press Secretary.
Mr. Shimkus. I would like to ask the committee to come to
order. I will now also recognize myself for 5 minutes for the
purpose of doing an opening statement.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Today marks our fifth hearing in this Congress on the Toxic
Substances Control Act. Our focus today is on two sections in
TSCA dedicated to getting EPA relevant testing data and other
information on chemical substances in United States commerce.
Past application of Section 4 by the EPA to obtain information
about existing chemicals has been frustrated by judicial
interpretation. We need to push beyond re-litigating those
cases and focus on what authorities the EPA has now, or could
reasonably use in the future to produce tailored, necessarily,
and high-quality test data, and other information to carry out
TSCA. We will also pick up on the discussion from the last
hearing on standards for data quality, and the use of the best
available science. The goal is credible decisions using high
quality data. Information management will be one of the
toughest areas to get right, but it is also one of the most
important.
I want to remind everyone that last summer former TSCA
program director Charlie Auer testified before our committee
that simply improving the way EPA is able to get information
under Section 4 would have profound impact on improving TSCA's
overall operation. Let us not kid ourselves, though;
information collection and analysis on thousands of chemicals
will become time consuming and very expensive. EPA will have to
be smart and efficient to make this program work, especially
when it comes to using available information, particularly
exposure history, in deciding whether more testing is needed,
and who should do the testing.
Today's hearing will also focus on reporting for the
thousands of chemicals in commerce. Section 8 requires the EPA
to develop and maintain an inventory of all chemicals, or
categories of chemicals, that are manufactured or processed in
the United States. It also gives the EPA authority to require
certain businesses involved with a chemical substance to
maintain records and submit health and safety information
report, particularly adverse health incidences caused by the
chemical to the EPA.
Within these reporting requirements, there are exemptions
for polymers, microorganisms, and naturally occurring
substances. We should find out if these make sense, and should
be continued, and what the incremental gain, if any, in public
health, resources, or protection occurs without these
exemptions. We also need to focus on the definition of
processor, and whether the definition is right-sized to the
person's activities and information EPA is receiving.
With that, I want to welcome our witnesses and thank them
for their expertise and candor. We expect them to provide a
variety of perspectives on when testing should be required, and
what we can do to improve testing techniques so we can speed up
analysis and reduce use of animals in that testing. We look
forward to their views.
And before I yield to the ranking member, I want to go off
script and also thank you. I think, in our questions and
response, candor is going to be important. There is a lot of
excitement in trying to move a bill, and move it properly. And
the other thing is, I was going back into the records, and I
think 1976 is when this was authorized and put into law, and I
had just graduated high school at that time, and started my
first year in college. So, suffice it to say that probably a
review and update of this law is timely, but we have to do it
right. A lot of you all here will help us muddle through that
process, and point out the good, and the bad, the ugly, and
maybe, working with my colleagues, we could find areas of
compromise.
[The prepared statement of Mr. Shimkus follows:]
Prepared statement of Hon. John Shimkus
Today marks our fifth hearing in this Congress on the Toxic
Substances Control Act. Our focus today is on the two sections
in TSCA dedicated to getting EPA relevant testing data and
other information on chemical substances in U.S. commerce.
Past application of section 4 by EPA to obtain information
about existing chemicals has been frustrated by judicial
interpretation. We need to push beyond re-litigating those
cases and focus on what authorities EPA has now or could
reasonably use in the future to produce tailored, necessary and
high-quality test data and other information to carry out TSCA.
We'll also pick up the discussion from the last hearing on
standards for data quality and the use of best available
science. The goal is credible decisions using high quality
data. Information management will be one of the toughest issue
areas to get right, but it's also one of the most important.
I want to remind everyone that last summer former TSCA
program director, Charlie Auer, testified before our committee
that simply improving the way EPA is able to get information
under Section 4 would have profound impacts on improving TSCA's
overall operation.
Let's not kid ourselves, though; information collection and
analysis on thousands of chemicals will become time-consuming
and expensive. EPA will have to be smart and efficient to make
this program work--especially when it comes to using available
information, particularly exposure history, in deciding whether
more testing is needed and who should do the testing.
Today's hearing will also focus on reporting for the
thousands of chemicals in commerce. Section 8 requires EPA to
develop and maintain an inventory of all chemicals, or
categories of chemicals that are manufactured or processed in
the United States. It also gives EPA authority to require
certain businesses involved with a chemical substance to
maintain records and submit health and safety information
reports, particularly adverse health incidences caused by the
chemical, to EPA.
Within these reporting requirements, there are exemptions
for polymers, microorganisms, and naturally occurring
substances. We should find out if these make sense and should
be continued and what the incremental gain, if any, in public
health resources and protection occurs without these
exemptions. We also need to focus on the definition of
processor and whether this definition is ``right-sized'' to the
persons, activities, and information EPA is receiving.
With that, I want to welcome our witnesses and thank them
for their expertise and candor. We expect them to provide a
variety of perspectives on when testing should be required and
what we can do to improve testing techniques so we can speed up
analysis and reduce use of animals in that testing. We look
forward to their views.
Mr. Shimkus. With that, I would like to yield to the
ranking member of the subcommittee, Mr. Tonko, for 5 minutes.
OPENING STATEMENT OF HON. PAUL TONKO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW YORK
Mr. Tonko. Thank you, Mr. Chair, and good morning, and
thank you for holding this hearing on the Toxic Substances
Control Act, or TSCA. This is the subcommittee's fifth hearing,
as we have been told, on this program. The hearings have been
very instructive, and are providing us with a good foundation
from which to evaluate the current law, and to develop
legislation to improve it. Reform of this legislation is long
overdue. I hope, Mr. Chair, that we will be able to work
together and find common ground in this effort, which I think
is critically important.
The two sections of TSCA we are focusing on today, Section
4, on chemical testing, and Section 8, on information reporting
and retention, have not provided sufficient reliable
information to support assessment and regulation of chemicals.
The authorities provided to EPA in these sections are weak and
cumbersome to implement. As a result, there is too little
information gathered on the toxicity or environmental risks
associated with chemicals, and the inventory of chemicals in
commerce does not provide sufficiently detailed and
contemporary data on the chemicals being used in the United
States. Currently, the burden is on EPA to demonstrate that
information is needed, rather than on industry to provide the
information to demonstrate that their product has been
adequately tested, and will present little risk when used
properly.
The tragic situation in Charleston, West Virginia
demonstrates several failings of our chemical safety laws. Not
all aspects of this incident can be blamed on the faults with
TSCA, but the lack of information needed to respond to this
situation illustrates the failure of this law. When the water
supply for the people of Charleston, West Virginia was
contaminated with chemicals that leaked from a storage tank,
there was little reliable information to provide the public,
emergency responders, or to the water company to guide their
response actions. As a result, there was public confusion and
concern about the advice offered by public officials and the
water company. There was little understanding of the fate of
the chemical in the water supply, or what health or
environmental effects might result from the spill.
This illustrates the importance of having adequate
information to inform decisions about the protection of human
health and our environment. Reform of TSCA must result in
better information, and clear authority for EPA to act. The
agency must have sufficient information to evaluate the risks
of chemicals currently on the market, and basic information
should be available before we have an accident, not slapped
together in the midst of a crisis.
The agency must be able to assess the risk of new chemicals
before they enter into commerce. Dr. Paulson informs us, in his
testimony, that a substantial portion of chemicals are known to
have a wide range of adverse, and most irreversible, effects on
child health. That is a prime warning. So it is important that
we move forward with a law that recognizes that fact, and
offers adequate protections for everyone.
I look forward to the testimony of our witnesses today, and
I thank you all for being here to share your views on what is a
very important topic. And, again, I thank you, Mr. Chair, and I
yield back.
Mr. Shimkus. I thank my colleague. Now the Chair recognizes
the chairman of the full committee, Mr. Upton, for 5 minutes.
OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF MICHIGAN
Mr. Upton. Well, thank you, Mr. Chairman. Today we are
going to continue our examination of TSCA with a focus on the
nuts and bolts of chemical information. For sure we want to
develop a system for chemical regulation that is the gold
standard for the rest of the world. It doesn't mean the most
precautionary, or the most commercially free-wheeling. It means
a balanced system rooted in the best science and highest-
quality information so that all of us can be confident that if
a chemical is in our stream of commerce, it is safe, and
commerce flows freely across State lines and across borders.
The foundation of that confidence should be information,
and that information must be grounded in rigorous science
available for everyone to review, organized by category, and
backed up by state-of-the-art testing when needed. The
technology of testing has vastly advanced since 1976, and it
will continue to evolve in a positive way. High power of
computers will simulate and sort exposure date and analyze
chemicals in batches by category so that time spent testing for
biological effects, and the need to test on live organisms, is,
in fact, reduced. We have also got to make sure that we don't
go overboard and become obsessed with data collection for its
own sake. There are thousands of chemicals in everyday life
that are understood to pose no unreasonable risk when used as
intended. We need to identify those based on information that
we already have. Then we can focus our resources, information,
development on the ones that we aren't so sure about. It is
often said that the job of the manager is to know when to stop
taking data, and start making decisions. That is the challenge
for EPA under a reformed TSCA.
It is also the challenge that we on the committee face as
we transition from our examination of current law to developing
our own ideas for how to modernize, after nearly 4 decades,
this body of regulation. So I look forward to working with
every one of our committee members as we set out on that path.
And I have every confidence in you, Mr. Shimkus, to chart a
successful course to get this job done. Really, I do. And I
also appreciate the leadership of Mr. Waxman, and Mr. Tonko,
and every member of this subcommittee for the hard work that
they have put in.
We need to chart a path that, yes, not only will reach the
House floor, but ultimately reach the President, and it needs
to happen this year. All of us have stayed focused through
these hearings and developed the policy expertise that will
benefit each of us in our deliberations. It is hard work that
attracts little publicity, but in the long run, our world is
certainly going to be better for it. And I yield back.
[The prepared statement of Mr. Upton follows:]
Prepared statement of Hon. Fred Upton
Today we continue our examination of TSCA with a focus on
the nuts and bolts of chemical information. We want to develop
a system for chemical regulation that is the gold standard for
the world.
That doesn't mean the most precautionary, or the most
commercially free-wheeling. It means a balanced system rooted
in the best science and highest quality information so we can
all be confident that if the chemical is in our stream of
commerce it is safe, and commerce flows freely across State
lines and across borders.
The foundation of that confidence should be information.
And that information must be grounded in rigorous science,
available for everyone to review, organized by category, and
backed up by state-of-the art testing when needed.
The technology of testing has vastly advanced since 1976
and it will continue to evolve. High power computers will
simulate and sort exposure data and analyze chemicals in
batches, by category, so that the time spent testing for
biological effects and need to test on live organisms is
reduced.
We've also got to make sure we don't go overboard and
become obsessed with data collection for its own sake. There
are thousands of chemicals in everyday life that are understood
to pose no unreasonable risk when used as intended. We need to
identify those, based on information we already have. Then we
can focus our resources and information development on the ones
we aren't so sure about.
It's often said that the job of the manager is to know when
to stop taking data and start making decisions. That's the
challenge for EPA under a reformed TSCA.
It's also the challenge we on the committee face as we
transition from our examination of current law to developing
our own ideas for how to modernize, after nearly four decades,
this body of regulation. I look forward to working with all of
our committee colleagues as we set out on that path.
Thank you, Chairman Shimkus, Mr. Tonko, and all the
subcommittee members for the hard work you've already put in.
You've stayed focused through these hearings and developed the
policy expertise that will benefit each of us in our
deliberations. It's hard work that attracts little publicity,
but in the long run, our world will be better for it.
Mr. Shimkus. The gentleman yields back his time. I want to
make sure I get that clip and send it to my spouse, so that she
knows that I am working----
Mr. Upton. And your high school science teacher.
Mr. Shimkus. No, I don't want to go there. Now, and this
will be the first of many times that we get to recognize the
ranking member, but, being the first one, I want to
congratulate Henry on his announcement. I don't expect him to
go away quietly. I do expect involvement after Congress still
with us and our issues. But, with that, let me yield 5 minutes
to the ranking member and chairman emeritus, Mr. Waxman, for 5
minutes.
OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mr. Waxman. Thank you very much, Mr. Chairman. I am going
to also give you a clip that you can share with your family,
because I agree with Chairman Upton. This is a time for us to
work together, and I want to work with you on reform of the
Toxic Substances Control Act. I believe TSCA is a flawed law
that must be updated, and we need to work together to do this.
Last month, State and Federal officials in West Virginia
were left scrambling when they could not find meaningful health
and safety data on a chemical that had polluted the drinking
water of 300,000 people. This disaster illustrated some serious
problems with the current law. New chemicals enter the market
without basic toxicity data. Untested chemicals remain on the
market, and chemical manufacturers often are not required to
submit tests that they do to EPA. This is an area ripe for
Congressional action, and holding a serious of hearing is a
step in the right direction.
But we also need to start bipartisan talks to see if we can
reach a compromise that protects the public from dangerous
toxic chemicals without unduly burdening industry. It is an
open secret that the majority staff is drafting a TSCA bill,
but at this point, they have shared nothing with the staff on
our side of the aisle. They haven't shown us language, or
explained their concepts for TSCA reform. Of course, Mr.
Chairman, this is your prerogative, but the reality is that an
unbalanced proposal simply isn't going to become law.
The Senate also has drafted a proposal for TSCA reform. The
chemical industry strongly supports it, but the public interest
community is deeply concerned about the proposal. We need to
strengthen TSCA, yet most environmental groups believe that the
Senate draft would actually weaken the current law. This looks
like a recipe for a stalemate, and we don't need too many
recipes for a stalemate. We get stalemates all the time without
a recipe.
If we are going to succeed, however, in reaching a
compromise that will become law, we need a formulation that
both sides, industry and environmentalists, can support, and I
think there is a way we can achieve this. It is not commonly
known, but in 2011 the American Chemistry Council, representing
industry, and the Safer Chemicals Health Family Coalition,
representing public health groups, sat down to see if they
could find common ground on TSCA reform. They found many areas
of agreement, and documented the agreement in a memorandum
prepared by the Meridian Institute. I believe this consensus
between industry and public health groups could be a basis for
productive discussions in this committee.
Later today I will be sending a letter to these groups and
requesting they share their results with our committee. And,
Mr. Chairman, I would like to invite you to join me in sending
this letter. The result of their careful policy discussions
just might be a blueprint for success in our committee.
In recent days I have been asked a lot about my views of
Congress, particularly since I announced I am leaving. Now
people want to know what I think about Congress. Well, I have
said that although there are aspects of Congress today that I
strongly dislike, I remain convinced that Congress can still be
a powerful force for good for our Nation. I hope we can
demonstrate that once again by working together on TSCA reform.
Only when we work together do we see successful legislation all
the way through to the President's signature. That is what we
need to do, initiate successful legislation in this committee,
and see it all the way through. We have a history of that in
our committee, and I hope we can go back to that pattern again.
Thank you, Mr. Chairman. Yield back my time.
Mr. Shimkus. Gentleman yields back his time. Now, again,
the Chair, I would like to welcome you all here. You will all
be given 5 minutes for your opening statement. Your full
statements will be recorded into the record. So we will start
from left to right. We will start with Mr. Charles Drevna,
President of the American Fuel and Petrochemical Manufacturers.
You are recognized for 5 minutes. Welcome.
STATEMENTS OF CHARLES T. DREVNA, PRESIDENT, AMERICAN FUEL &
PETROCHEMICAL MANUFACTURERS; ROBERT A. MATTHEWS, MCKENNA, LONG
& ALDRIDGE, LLP, ON BEHALF OF THE CONSUMER SPECIALTY PRODUCTS
ASSOCIATION; BRENT GRAZMAN, VICE PRESIDENT, QUALITY ASSURANCE,
VIASYSTEMS GROUP, INC., ON BEHALF OF IPC-THE ASSOCIATION
CONNECTING ELECTRONICS INDUSTRIES; BETH D. BOSLEY, PRESIDENT,
BORON SPECIALTIES, ON BEHALF OF THE SOCIETY OF CHEMICAL
MANUFACTURERS AND AFFILIATES; CATHERINE WILLETT, DIRECTOR,
REGULATORY TOXICOLOGY, RISK ASSESSMENT, AND ALTERNATIVES, THE
HUMANE SOCIETY OF THE UNITED STATES; JENNIFER SASS, SENIOR
SCIENTIST, NATURAL RESOURCES DEFENSE COUNCIL; AND JEROME
PAULSON, CHAIRPERSON, EXECUTIVE COMMITTEE OF THE COUNCIL ON
ENVIRONMENTAL HEALTH, AMERICAN ACADEMY OF PEDIATRICS
STATEMENT OF CHARLES T. DREVNA
Mr. Drevna. Chairman Shimkus, Ranking Member Tonko, and
Full Committee Chair Mr. Upton, and Mr. Waxman, members of the
subcommittee, I am Charlie Drevna, President of American Fuel
and Petrochemical Manufacturers. As the name implies, AFPM
represents high tech manufacturers. While most people are
familiar with the fuels they use every day, many are not
familiar with the petrochemicals. Petrochemicals are the
industrial building blocks that make the materials,
ingredients, and processing agents that appear throughout a
variety of manufacturing supply chains. Whether it is the
plastic casing of your cell phone, excuse me, the aspirin in
your medicine chest, or even the helmet worn by a loved one in
the military, petrochemicals, such as ethylene and propylene
play a critical role in manufacturing, and in our lives every
day.
TSCA is a unique statute in that it has much to do with
commerce and the manufacturing supply chain as it does with
human health, and the environment. TSCA gives the EPA broad
power to regulate chemicals in commerce. While AFPM supports
rational modernization of TSCA, great care must be taken so
that the manufacturing supply chains are not disrupted. This is
one statute where our members believe that a strong Federal
role is required to maintain the interstate flow of raw
materials and goods.
Since its enactment in 1976, we have learned that the
implementation of TSCA has been challenging for EPA in certain
areas, and there is still debate over whether the challenges
have been due to the statute, or due to some of the choices the
agency has made. I believe it is time to take a fresh look at
how we control chemicals in commerce, and again try to strike
that balance between helping the environment, and a globally
competitive manufacturing supply chain.
The U.S. is on the brink of a manufacturing renaissance,
due in large part to dramatic reductions in the cost of energy
and raw materials. Shale development has fostered the most
globally competitive positioning for American manufacturers I
have ever witnessed. Given this opportunity, when it comes to
laws that affect the feed stocks driving the manufacturing
renaissance, we must get TSCA modernization right. To begin,
AFPM supports a bipartisan effort to modernize TSCA. That means
a new starting point for discussion, and a constructive
dialogue. I echo Mr. Waxman's comments there. The current TSCA
statute provides a solid backbone for chemical regulation, but
AFPM does see room for improvement.
One area for improvement is more guidance from Congress
that directs the EPA to prioritize chemicals in commerce. AFPM
views prioritization efforts under the Canadian chemical
management program as a reasonable, achievable model. The
approach used in Canada is a screening level look at chemical
hazard and exposure to tell scientists whether or not more work
is needed to deem a substance safe for its intended use, and
the conditions of that use. Currently the EPA has sophisticated
and protective models that it uses to evaluate the potential
hazards of chemicals. The agency collects data under the
chemical data reporting rule to determine the exposure
potential of chemical substances. So there are no technical or
practical reasons that EPA cannot prioritize chemicals for
further work.
Congress should also include provisions that increase
scientific quality and transparency at the agency. Specific
language should require EPA to develop criteria by which the
agency and public can judge the quality of scientific studies
under consideration, as well as EPA risk assessments.
An important part of TSCA is Section 4, which authorizes
the EPA to require laboratory testing of certain chemicals. I
tend to agree that under Section 4, the prerequisite for EPA to
find a risk posed by a chemical before it can require testing
for that chemical does not make sense. The exposure finding, on
the other hand, is a built in check and balance to prevent EPA
from demanding unreasonable animal intensive tests that will
not lead to a further and better understanding of safety. AFPM
firmly believes that there should be an exposure basis before
EPA can require animal testing.
AFPM's highest level principles state that TSCA should be a
tiered, targeted, and risk based approach. This is especially
true for testing and data collection. A tiered approach begins
with the use of existing information, protective models, and
structure activity relationships. If there is an unreasonable
amount of scientific uncertainty at a screening level, then the
substance would be subject to the next tier, in which
information is collected to reduce the uncertainty.
When it comes to Section 8, which authorizes the EPA to
collect information that provides an accurate reflection of
chemicals to commerce, Congress should also provide specific
guidance. For example, the chemical data reporting rule, EPA is
required for producers to use exposure information.
In closing, there are other sections of TSCA that may need
updating, but I am confident that the subcommittee will address
those issues at a later date. Thank you Mr. Chairman, Ranking
Member Tonko, and subcommittee members for allowing us the
opportunity to express our views.
[The prepared statement of Mr. Drevna follows:]
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Mr. Shimkus. Thank you, Mr. Drevna. Now the Chair
recognizes Mr. Robert Matthews from McKenna, Long, and
Aldridge, on behalf of the Consumer Specialty Products
Association. Sir, you are recognized for 5 minutes.
STATEMENT OF ROBERT A. MATTHEWS
Mr. Matthews. Thank you. Good morning, Mr. Chairman,
Ranking Member Tonko, members of the committee. It is a
pleasure and privilege to appear before this committee on
behalf of the Consumer Specialty Products Association. It is
our firm's oldest client. We have been representing their
interests for over 5 decades. So it is my privilege to appear
on their behalf, and before your subcommittee.
In fact, this year CSPA celebrates its 100-year anniversary
serving as the premiere trade association representing the
interests of companies both large and small. A good half of
their companies are small businesses, the companies that
formulate and market household and institutional products.
In our written testimony, and in my comments today, we
refer to our members as formulators, which is a segment of the
downstream companies that are more generally referred to as
processes. CSPA and its member companies have consistently
advocated for the need to update the TSCA statute, and,
importantly, recognize the role of downstream formulators in
that process. CSPA's role and interest in TSCA is to assure the
process is working in a way that protects public health and the
environment, allows companies to continue to operate
effectively and efficiently in commerce, and maximizes consumer
confidence in chemical safety, and by extension, in the branded
products that we place on the market.
CSPA's support for modernizing TSCA is rooted in three
principle considerations. First, it is critical, as I just
mentioned, that consumers have confidence in these formulated
products. Maintaining that high level of confidence in the
safety of chemicals used in their products placed on the market
is of utmost concern to CSPA and its member companies.
Second, CSPA member companies who sell formulated household
and institutional products increasingly face a multitude of
State regulations, indeed, not only at the State, but at the
local level, as legislative and regulatory entities are simply
not waiting for Congress to act to modernize this statute. So
we support modernization because it will create a more
predictable environment in which companies can engage in
interstate commerce.
And, finally, among the reasons we have continually
supported changes and modernization of TSCA is because our
companies, like others in industry, are impacted by the
adoption and globalization of the EU Reach program, with its
focus on regulation by hazardous properties of chemicals, and
its calls for massive data into the system that is often
unnecessary, costly, and burdensome. We think this is an
opportunity for the United States to assert its leadership in
establishing risk based global chemical management programs.
So I am now, with that background, pleased to share with
you our very specific thoughts on how CSPA and its member
companies can meaningfully participate in the TSCA statute that
would emerge after modernization. So we have focused in
particular on the issues that impact our members. Those include
in particular one that is before this committee today. That is
Section 8, and the reporting provisions thereunder. We have
also focused considerable attention on the confidential
business information, or CBI, provisions of Section 14. So I
will largely focus on Section 8, as this committee has
requested, and the impact of that section on the prioritization
program under Section 4.
The key to a modernized TSCA is an affirmation of a risk
based chemical management system, meaning that at the time that
EPA is prioritizing chemicals for review, and setting
standards, they are focused not only on the hazard, or
intrinsic properties of that chemical, but the manner in which
those chemicals are used, and the potential exposures that they
create.
But as it supports a risk based approach, CSPA has also
recognized three related points. First, indeed, a risk based
system starts with prioritization, where EPA screens chemicals
in commerce to identify which ones should be subject to further
review, and potentially to a safety assessment. Given the large
number of chemicals in process, it is imperative that there be
an effective screening process. Second, to properly screen, and
indeed, again, potentially to conduct risk assessments, EPA
must have information on how those chemicals are being used,
and their potential exposure scenarios that they crate. And
that leads to the third point, which is EPA has to have to have
the means to get that information from where that information
lies, which is principally with the downstream community, who
know much more about use and exposure than do the raw material
manufacturers.
So the role of formulators under a revised TSCA, therefore,
can be very much defined and targeted for that purpose. We have
spent considerable time focusing on the elements that would be
useful in that regard that would impact our member companies.
So we have done so in a manner that aligns what we think is
EPA's needs at the prioritization stage with the information
that we have. So we would propose to submit to the agency
information that involves chemicals that will be placed in
products, information on chemicals that are placed in products
intended for use by children, information on the concentration
range of the chemicals in those products, and, indeed, the
number of workers, that is, who are involved in formulating
those materials. Combined with the hazard materials, that is to
say the hazard information, that EPA would have from the
chemical producers, this would give EPA all that it needs in
regard to prioritization.
So I have much more to say about confidential business
information. Perhaps that will come up, but that is the
principle focus of our efforts, is to get that kind of use and
exposure information into the agency. Thank you.
[The prepared statement of Mr. Matthews follows:]
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Mr. Shimkus. Thank you. Now the Chair recognizes Dr. Brent
Grazman, Vice President for Quality Assurance, Viasystems
Group, Incorporated, on behalf of the IPC, Association
Connecting Electronics Industries, and more importantly from
the St. Louis Metropolitan area, which is where I reside. So
with that, welcome. You are recognized for 5 minutes.
STATEMENT OF BRENT GRAZMAN
Mr. Grazman. Thank you, Mr. Chairman, and members of the
committee for the opportunity address you today. Viasystems is
a global manufacturer of printed circuit boards. We are
headquartered, as the Chairman mentioned, in St. Louis. We
employ over 2,000 people in the U.S. in eight different
factories, including North Jackson, Ohio, and Littleton,
Colorado. We make printed circuit boards that are used by
leading manufacturers of transportation, telecommunications,
medical, defense, and aerospace products.
I am also here to represent IPC, the Association Connecting
Electronics Industries. IPC is a global trade association
representing over 2,000 electronics manufacturers in the U.S.
As a member of IPC's government relations committee, I want to
emphasize that IPC and its members, including Viasystems, are
all strong advocates for science-based regulation that improves
the environment, protects human health, and stimulates the
economy. In my testimony I will highlight our concerns about
TSCA Section 8 as it applies to byproducts reporting.
It is critical that Congress reform TSCA in a way that
directs the Environmental Protection Agency to focus and
prioritize its regulation of chemicals. Selection of priority
chemicals should be based on sound science. Substances that
exhibit the greatest hazard and impose the greatest exposure to
consumers should be given priority for review for testing, and
as needed for regulation. A targeted, prioritized approach will
allow the EPA and industry to both more effectively use our
limited resources to protect human health and the environment.
An example of EPA's failure to prioritize chemical
regulation is the treatment of byproducts. Under TSCA, the EPA
treats byproducts as new chemicals if they are sent for
recycling. But if we sent them for disposal, there is no TSCA
requirement invoked. As a new chemical, the byproduct sent for
recycling must be listed on the TSCA inventory, and is subject
to the full regiment of TSCA recordkeeping, reporting, and
enforcement. Let me emphasize all of these regulatory
obligations arise solely because a manufacturer, like
Viasystems, sends a byproduct for recycling, rather than just
disposing of it.
TSCA contains specific exemptions for byproducts, but the
EPA has narrowly interpreted these exemptions to apply only if
the recycler does not use a chemical reaction to recover
substances from the byproduct. Recovery of metals, like gold,
tin, and copper, that are in our byproducts is impossible
without the use of the chemical reaction. We manufacture
printed circuit boards like this one. We don't manufacture
chemicals.
The EPA requires us to know, at a molecular level, what the
recyclers of our byproducts do with our byproducts. The
recycler's processes are outside of our control. They are often
proprietary, and they can change day to day, based on the
market conditions that those recyclers see. The result is a
regulatory policy that forces companies to report data based on
incomplete information and assumptions, ultimately compromising
the data quality. EPA's overreaching interpretation affects a
lot more facilities and companies than those represented by the
IPC. Manufacturers from many industries are burdened by
reporting their byproducts as new chemicals at the point when
they send them for recycling.
Much of the data that we repot about byproducts under TSCA
is also required by the Resource Conservation and Recovery Act,
and the Emergency Planning and Community Right to Know Act.
Under TSCA, the recyclers are required to report the new
chemicals they manufacture from our byproducts. The EPA
unnecessarily burdens industry with the reporting of vast and
duplicative data for some unknown future uses.
As a Nation, we recognize reduce, reuse, and recycle as
goals. The EPA undercuts those goals with regulatory policy
that effectively discourages us from recycling. We encourage
Congress to explicitly exempt all byproducts, including those
that are sent for recycling. As I mentioned earlier, we
manufacture printed circuit boards, not chemicals. The focus of
TSCA, pardon me, should remain on ensuring the safety of
chemicals in commerce. EPA's authority to regulate articles,
like printed circuit boards, should be limited to situations
where regulating the chemicals themselves is not enough to
protect human health and the environment.
In conclusion, IPC supports cost effective, science based
environmental regulation. As I have discussed, it is critical
that Congress reform TSCA in a way that directs the EPA to
focus and prioritize its regulation of chemicals. We believe
that EPA's reporting requirements for byproducts sent for
recycling are burdensome, unnecessary, and, as I mentioned,
they actually discourage recycling.
Thank you again for this opportunity to appear before you.
I will be happy to answer any questions when the time is right.
[The prepared statement of Mr. Grazman follows:]
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Mr. Shimkus. Thank you, sir. Now the Chair recognizes Dr.
Beth Bosley, President, Boron Specialties, on behalf of the
Society of Chemical Manufacturers and Affiliates. You are
recognized for 5 minutes. Welcome.
STATEMENT OF BETH D. BOSLEY
Ms. Bosley. Good morning, Chairman Shimkus, Ranking Member
Tonko, and members of the subcommittee. I am pleased to
testify----
Mr. Shimkus. Can you just pull that microphone just a
little bit closer to you?
Ms. Bosley. There we go. I am pleased to testify once again
on behalf of the Society of Chemical Manufacturers and
Affiliates regarding TSCA today on Section 4 and Section 8.
Just a background on SOCMA, over 80 percent of our members are
small businesses. For example, my business just hired its
eighth employee. Even with that small staff, we are committed
to responsibly manufacturing our products here in the United
States. We produce unique chemicals by novel manufacturing
techniques that are used in the electronics, aerospace, and
nuclear energy sectors.
SOCMA members' unique niche in the chemical industry is
known for its innovation, entrepreneurship, and customer focus.
I would like to begin by saying that SOCMA remains committed to
strengthening TSCA, and appreciates the subcommittee's work in
this aspect.
We should avoid approaches to TSCA reform that would treat
the vast universe of TSCA chemicals like the far narrower
universes of food additives, drugs, and pesticides. In
particular, the sheer number of new chemicals that are
submitted to EPA each year, and the evolving market needs, mean
that use by use approvals make sense for drugs and pesticides
will not work for industrial chemicals in general. A TSCA
reform bill should be fundamentally risk based, as you have
heard from other witnesses at the table, and it should require
EPA to look at a chemical's inherent hazards, along with its
exposures, when making regulatory decisions.
An improved Section 4 should be tiered, targeted, and risk
based. Generally stated, the real problem with TSCA has been
the treatment of existing chemicals. Section 4 gives the EPA
authority to require testing of existing chemical substances
and mixtures once certain criteria are met. In this section,
that allows EPA to obtain measured data on existing chemicals
of currently available data and experience, are insufficient to
reasonably predict their effects.
The major shortcoming in this section is actually
procedural. EPA is required to go through a rulemaking process,
which has contributed to delays in EPA getting the data that
they need. For example, EPA has taken years to finalize a
number of high production volume chemical test rules, even
though the industry has strongly supported such test rules.
Voluntary efforts and enforceable consent agreements have
helped streamline the testing process, but this section of TSCA
could be strengthened by considering authorization for EPA to
issue orders similar to the way it issues orders for new
chemicals.
Any orders for testing approaches should be tiered and
targeted. That is, they should start off at a screening level,
and focus the testing where the risk is greatest. A screening
level analysis may show that hazard is sufficiently low that
additional test data will not be necessary. The same goes for
scenarios where exposures are highly unlikely. We support the
notion that EPA should have to abide by basic standards of
scientific quality, and specify in accepting screening and
testing data. We also believe alternatives to animal testing
should be supported, where they are sufficient validated.
The second major shortcoming of Section 4 is the lack of
any requirement that EPA act on a specific number, or a
percentage of existing chemicals, by any particular time.
Congress should remove obstacles to more comprehensive EPA
evaluation of inventory chemicals by mandating EPA to review a
minimum number of chemicals annually via a risk-based
prioritization process. We believe EPA has the expertise to do
this. There are very talented scientist and engineers at EPA.
Unfortunately, they don't have the resources to do that at this
time. Reforms to Section 8 could give EPA a better
understanding of the exposure scenarios and able it to
prioritize more efficiently.
As mentioned above, testing of existing chemicals, should
be tiered, targeted, and risk-based. Improvements to TSCA
Section 8 could help EPA determine whether an existing chemical
warrants testing. One way Section 8 could be improved is by
requiring an inventory reset to ensure that the inventory of
existing chemicals is current. This effort will also pare down
the initial number of chemicals to be evaluated. It is a
concept we have supported for many years, and believe it is a
vital first step to a robust and efficient existing chemicals
policy.
Another significant problem with Section 8 is that it does
not authorize EPA to collect use or exposure information from
anyone downstream of manufacturers or processors. The result is
that, in many cases, manufacturers are forced to make educated
guesses about the end use markets and exposure scenarios
surrounding the use of their products. SOCMA would like to see
an expansion of this section to allow collection of information
from non-consumer downstream entities.
Finally, we urge you to amend Section 8(e) to authorize
manufacturers, processors, and commercial downstream
distributers and users to file reports with the EPA regarding
non-adverse findings about chemicals. Currently there is no
mechanism to report such non-adverse date. The result is that
the public database on existing chemicals is unnecessarily
limited and biased toward the bad news. With reasonable
amendments, TSCA could provide an easier mechanism to submit
such information.
As I conclude, it is important to mention that the
Lautenberg-Vitter Chemical Safety Improvement Act introduced
into the Senate last year is a remarkable example of well-
reasoned bipartisan TSCA legislation, and we endorse it as a
vehicle for reform. The subcommittee should be able to leverage
much of the work done there, including the work on Sections 4
and 8. Thanks for this opportunity. I will be happy to answer
any questions.
[The prepared statement of Ms. Bosley follows:]
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Mr. Shimkus. Thank you. And before I go to Dr. Willett, we
did have Senator Vitter and the new co-sponsor, Senator Udall,
here for a hearing on this bill, and we applaud their work, and
look forward to building on that.
The chair now recognizes Dr. Catherine Willett, Director of
Regulatory Toxicology Risk Assessment and Alternatives from The
Humane Society of the United States of America. Welcome, and
you are recognized for 5 minutes.
STATEMENT OF CATHERINE WILLETT
Ms. Willett. Thank you, Chairman Shimkus and Ranking
Member----
Mr. Shimkus. Pull that mike just a little bit closer to
you, because we want everyone to hear you.
Ms. Willett. OK. Thank you. Thank you, Chairman Shimkus,
and Ranking Member Tonko, for the opportunity to testify on
behalf of The Humane Society of the United States, the Humane
Society Legislative Fund, two members of the Nation's largest
animal protection organization. We strongly support animal
protection, and also public health and environmental safety for
the animals that are in our environment, and we believe that
the Environmental Protection Agency should have the tools
necessary to appropriately regulate chemicals in the United
States.
I am excited to be here to discuss the opportunities for
21st century science to impact Section 4 of the Toxic
Substances Control Act. I have been a bench scientist for 20
years, and some of those years I was a practicing toxicologist.
For the past 7 years I have worked internationally on chemicals
policy.
As mentioned by Chairman Upton, the science that underpins
chemical characterization has undergone a radical
transformation in recent years, as outlined in a 2007 report by
the National Research Council, and which has also been taken up
by EPA in their recent strategic plans. The report's conclusion
is that reduced reliance on whole animal testing leads to a
more relevant and efficient toxicity testing paradigm,
resulting in increased protection for humans and the
environment.
Rather than relying on a rote battery of animal tests, this
new approach involves an iterative process of chemical
characterization, toxicity testing, and extrapolation modeling,
informed by population based data and human exposure
information. This transformation is in response to challenges
the EPA has experienced in obtaining data on the tens of
thousands of chemicals to which people and the environment are
potentially exposed, and in accommodating increasingly complex
issues, for example, life stage susceptibility, the effect of
mixtures, varying exposure scenarios, and cumulative risk.
Any effective modification of TSCA must allow for, and
encourage, adoption of these evolving strategies. By
articulating this in any legislative proposal, Congress will
also send a strong message that more effective chemical
regulation is dependent on more effective, and humane,
chemicals testing. To do this, we urge Congress to be mindful
of the following considerations. As also mentioned by Chairman
Upton, computational cell and tissue based methods can now be
used to prioritized chemicals, or groups of chemicals, that are
of primary concern. These methods can also be used to satisfy
information needs in some cases for some chemicals. Further
development and application of these methods for use in risk
assessment should be encouraged.
Updated legislation should be flexible enough to allow the
inclusion of new testing methods and strategies as they are
developed. New legislation should provide EPA with significant
commitment for creating the necessary infrastructure to do
this. New legislation should also offer strong incentives for
companies to fund, develop, and use new methods and testing
strategies. And, as non-animal alternative methods become
available, the use of such methods should be required in place
of animal tests. We foresee a time when the principle of animal
testing is a last resort.
Protecting human health and the environment is a critical
goal of effective chemicals regulation. In order to achieve
this goal, it is necessary for any new legislation to allow and
support the continuing evolution of the science of chemical
assessment. The Humane Society of the United States hopes that
we will have the opportunity to work with you on any
legislative language to reauthorize aspects, or the entirety of
TSCA. Thank you very much.
[The prepared statement of Ms. Willett follows:]
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Mr. Shimkus. Thank you. The Chair now recognizes Dr.
Jennifer Sass, Senior Scientist, National Resources Defense
Council. You are recognized for 5 minutes. Welcome.
STATEMENT OF JENNIFER SASS
Ms. Sass. Thank you very much, Chairman Shimkus, and
Ranking Member----
Mr. Shimkus. Also, just pull that, there you go.
Ms. Sass. Closer? OK.
Mr. Shimkus. And if you can point the microphone to where
your mouth is?
Ms. Sass. Nobody ever complains about not hearing me, so I
want----
Mr. Shimkus. Well, our transcribist was freaking out over
there, so----
Ms. Sass [continuing]. It on record. Thank you for the
invitation to be here, and to testify on this very important
issue. As Mr. Waxman stated in his opening comments, TSCA is a
statute that has failed to protect the public, and that is
certainly true of its provisions regarding testing and data
collection, which we are here to discuss today. TSCA needlessly
impedes the collection of such information, with predictable
results.
In the wake of the recent spill in West Virginia, the
impact of the information gaps in TSCA are more visible. The
leaking of 4-methylcyclohexanemethanol, the MCHM, and other
chemicals into the Elk River in West Virginia brought home,
literally into peoples' homes, the disturbing reality that no
useful information is available to the public, or those who
serve them. In fact, a Pugh Health Group research fact sheet
put out in 2010 found that roughly 3,000 chemicals used in over
one million pounds annually in the U.S., these are the HPV, or
high production volume chemicals, may have no information
regarding potential developmental or pediatric toxicity.
Nonetheless, over 700 of them are used in consumer products.
CDC bio-monitoring has found over 200 synthetic chemicals in
the blood and urine of Americans.
TSCA provisions set an excessively high bar that has
effectively prevented EPA from getting information. First EPA
must essentially prove that a chemical poses an unreasonable
risk to health or the environment before it can require the
needed testing that would show a potential risk. This is like
requiring a doctor to prove that a patient has cancer before
being able to order a biopsy. It is a catch-22 construction of
EPA's testing authority that has greatly constrained the agency
from getting data through testing in a timely manner. Second,
to require testing of existing chemicals, EPA must complete a
full formal rulemaking. Other programs, including the pesticide
program, and even TSCA's new chemical program, instead allow
EPA to require testing by issuing an order, which is a much
more streamlined process.
As a result of these systems of hurdles and procedural
hurdles, in the nearly 40 years since TSCA's enactment, EPA has
required a full set of testing data on only a few hundred of
the 62,000 grandfathered chemicals that came in under the law
in 1976. The good news is that the flaws in Section 4 of TSCA
can be resolved relatively easily by eliminating the catch-22
provisions of Section 4 and allowing the agency to require
testing by order, rather than by rule, the bottleneck would
largely be eliminated, and the agency would begin to get more
information in a timely manner necessary to inform and protect
the public.
The failure of TSCA, and the subsequent action at the State
level to collect information, and to limit the use of harmful
chemicals, has prompted renewed discussion of TSCA reform,
which is useful, but the Chemical Safety Improvement Act, S
1009, as introduced will not solve the problems with current
TSCA, and in some respects, will make things worse. The
introduced bill would prevent EPA from requiring testing for a
chemical until it has already been identified as a high
priority substance. This essentially replicates the existing
catch-22. EPA would generally need evidence of hazard or
exposure for a chemical to be designated high priority in the
first place. Although EPA would be allowed to require testing
for high priority chemicals by order, the universe of potential
chemicals for which EPA could require testing would likely be
greatly reduced.
We also need more detailed use and exposure information for
chemicals, as has been mentioned by other speakers, beyond what
is currently captured in EPA's chemical data reporting rule.
Unfortunately, the chemical industry has routinely failed to
provide updated production use and exposure data, and
strenuously resisted government action to collect it.
Various proposals have been made to reset the TSCA
inventory as part of TSCA reform. If this is undertaken,
Congress should not in any way delay efforts currently underway
to take expedited action on substances, such as chemicals that
are PBTs, the persistent bio-cumulative and toxic ones, or
other chemicals for which we already have sufficient
information to know that they are unsafe, or slow, for example,
EPA's current efforts to review its work plan chemicals.
Second, if a substance is taken off the TSCA inventory, it
should not be able to re-enter the inventory without going
through a review process. A disturbing example is the
firemaster 550, which ended up back in products, and in blood
and breast milk. It is possible to have a balanced information
regime that would protect the public, while helping industry by
increasing public confidence in its products. The committee can
play a critical role in this, and we are happy to work on that,
but we are not there now.
Thank you.
[The prepared statement of Ms. Sass follows:]
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Mr. Shimkus. Thank you. And last, but not least, we have
Dr. Jerry Paulson, who is the chairperson of the Council on
Environmental Health, Department of Federal Affairs, American
Academy of Pediatrics. Sir, you are welcome, and you are
recognized for 5 minutes.
STATEMENT OF JEROME PAULSON
Mr. Paulson. Good morning, Chairman Shimkus, and Ranking
Member Tonko, and members of the subcommittee. Thank you for
this opportunity to testify today about the testing and data
collection requirements under the Toxic Substances Control Act
of 1976. I am Dr. Jerome Paulson, and I am here representing
the American Academy of Pediatrics, a non-profit professional
organization of 60,000 pediatricians dedicated to the health,
safety, and well-being of infants, children, and adolescents.
As mentioned, I currently serve as the chair of the AEP's
council on environmental health. I will summarize my written
statement, a full copy of which I have submitted for the
record.
Chemical management reform is an important policy that
uniquely impacts children's health. Children are not little
adults. They have unique physiologic, behavioral, and
developmental differences that amplify their exposure to
chemicals in the environment. For example, infants may be
exposed to contaminants in water used in formula preparation.
Nobody else drinks formula. Toddlers engage in normal mouthing
behaviors, where they put objects into their mouths, that may
expose them to dangerous toxins. Children spend more time on
the floor, or the ground, and come into more contact with
contaminants on those surfaces. If we had kids in the hearing
room today, they wouldn't be sitting on chairs.
U.S. Centers for Disease Control and Prevention researchers
have found measurable levels of over 200 common industrial
chemicals in body tissues and fluids of children of all ages,
including cord blood. A number of hazardous chemicals also
appear in breast milk. A substantial proportion, as Mr. Tonko
mentioned, of chemicals known to have adverse, and mostly
irreversible, effects on child health, such as lowering IQ,
negative behavioral effects, and low birth weight, and reduced
head circumference.
The safety testing requirements under Section 4 of TSCA are
inadequate to protect children's health, and place too great a
burden for safety testing on the public sector. Chemicals
introduced into commerce when the law was enacted are subjected
to scant oversight. For new chemicals, the process basically
doesn't work, and unless this legislation is reformed, with the
tens of thousands of chemicals in need of review, and the
multi-year process for each undertaking, it would require many
decades just to review high production volume chemicals. These
flaws limit EPA's ability to protect the most vulnerable,
including children and pregnant women, because the agency faces
substantial barriers to obtain the information needed to make
effective risk management decisions.
Under Section 8, TSCA has created a non-evidence based
system for chemical management. Concerns about chemicals are
permitted to be kept from the public. In their notifications to
EPA, chemical companies may declare large amounts of
information to be confidential business information. This broad
exemption has effectively prevented the Environmental
Protection Agency from sharing information about potential
hazardous chemicals with community groups, local and State
governments, and other organizations. Certainly an effective
management system must include greater transparency than
currently exists.
Given the current urgent ongoing threat to children posed
by chemical exposures, the American Academy of Pediatrics
respectfully submits the following key recommendations for
reforming the Toxic Substances Control Act. Under Section 4,
manufacturers should be required to provide minimum data sets,
with information that is relevant to the special needs of
pregnant women and children regarding reproductive,
developmental, neurodevelopmental toxicity, and endocrine
disruption. Furthermore, EPA needs the flexibility to change
data collection processes as new methodologies for testing
become available.
Under Section 4, the EPA should have a simple process to
require additional testing when information suggests the need,
especially for chemicals associated with child populations. The
CDC's bio-monitoring program must be expanded to serve as an
early warning system for exposures. Aggregate and cumulative
exposure concepts similar to those in the Food Quality
Protection Act should be considered by EPA. Companies must
develop public information documents for each new chemical
marketed that utilizes lay language, and is updated regularly.
In conclusion, strong chemical management policy must
integrate evidence-based decision-making for chemical use to
adequately protect children, and other vulnerable populations
from harm. The American Academy of Pediatrics looks forward to
working with you to advance sound and protective chemical
management policy during the 113th Congress. And I will be
happy to entertain questions.
[The prepared statement of Mr. Paulson follows:]
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Mr. Shimkus. Thank you very much. Now I would like to
recognize myself for 5 minutes for the first round of, maybe
the only round of, opening questions.
So my first one goes to Mr. Drevna. Section 8 contains
regulatory exemptions, as currently written. Some of these are
for polymers and naturally occurring substances. Would you have
concerns if a TSCA reform would invalidate those practices?
Mr. Drevna. Well, Mr. Chairman, I believe that Section 8
needs some reform, but I think there is a major misconception
about, you know, what is out there, the 80,000 or so that some
people say of chemicals that are out there, and really the
10,000 or so that are in commerce. So I think what Congress
should do is direct the EPA to say, OK, this is what is out
there, and what is out there has to be, as many of the
witnesses have said, has to, you know, any regulation has to be
tiered, targeted, and risk-based.
I believe, from hearing most of the witnesses here, if not
all, but I think we all agree on it. I think it is what the
definition of that is, and what the ultimate goal of the
modernization of TSCA should be. So I think if we can agree on
what is out there, allow EPA to do a tiered, targeted, risk-
based approach, we can all get to the end goal here.
Mr. Shimkus. Thank you. Now, you know, we are not
adversarial, so what I would like to do is try to get answers
quickly. And it is a big panel, so this is for everyone on the
panel, but for everyone to get through, please be as concise as
possible. Does it make sense to have information quality
standards for EPA to make decisions about chemicals? Mr.
Drevna?
Mr. Drevna. It makes sense for EPA to have the authority to
find out what is out there, and, again, do the tiered,
targeted, risk-based approach, and have the authority to do the
testing----
Mr. Shimkus. Quickly.
Mr. Drevna [continuing]. Get rid of Section 4, the risk
assessment first. We agree to that.
Mr. Shimkus. Mr. Matthews?
Mr. Matthews. It is always hard to argue with the notion
that we should have quality standards in what EPA does. So,
yes, we support EPA using the best available science and modern
techniques.
Mr. Shimkus. Mr. Grazman?
Mr. Grazman. Yes, sir, we agree with you too.
Mr. Shimkus. Thank you. Dr. Bosley?
Ms. Bosley. Yes, absolutely. Information quality is of
utmost importance.
Mr. Shimkus. Dr. Willett?
Ms. Willett. Yes, and EPA and other regulatory agencies
have some of these, but they might be improved.
Mr. Shimkus. Dr. Sass?
Ms. Sass. My concern about having them hardwired into the
system, while I think everybody agrees in principle, I think
the process that the agencies are taking now to develop those
in a public and transparent way, with public comment, is the
approach that should be taken.
Mr. Shimkus. Dr. Paulson?
Mr. Paulson. Quality standards are important, but I don't
think they should be in the legislation. The EPA needs the
flexibility to change with time. And, as new technologies for
chemical testing come on the market, they need to be able to
respond to that.
Mr. Shimkus. And my next question follows along on that
response. Should different standards apply to testing? Mr.
Drevna?
Mr. Drevna. Yes.
Mr. Shimkus. Thank you. Mr. Matthews?
Mr. Matthews. Yes.
Mr. Shimkus. Grazman?
Mr. Grazman. I have got to defer. We are manufacturers,
not----
Mr. Shimkus. Right. Very good. Dr. Bosley?
Ms. Bosley. Sure, should be based on risk.
Mr. Shimkus. Dr. Willett?
Ms. Willett. I am not sure I understand the question, I am
sorry.
Mr. Shimkus. Chemicals and processes are not all the same,
so the question is should there be different standards applied,
or should there be different standards to the level of risk-
based chemical that might be out there?
Ms. Willett. Yes, I believe that is true, but I think I may
tend to agree that it might not be a legislative issue.
Mr. Shimkus. Dr. Sass?
Ms. Sass. I think your question is about whether we should
treat chemicals differently depending not only on their hazard,
but also on their exposure. And while I agree that there is
some intelligence to that, the concern is that we have very
little exposure information, so there is a practicality that is
lacking.
Mr. Shimkus. Thank you. Dr. Paulson?
Mr. Paulson. Mr. Shimkus, here again I think the EPA needs
to have some flexibility. For example, had we only used hazard
information on the chemical that was spilled in West Virginia,
which was an industrial chemical, never intended for human
exposure, other than the workers, then that chemical would not
be reviewed. But, in retrospect, we are obviously in a
situation where we wish it had been. So the EPA needs some
flexibility. And we know, with the current law, the legislation
has boxed them in in such ways that they can't function. We
should not repeat that.
Mr. Shimkus. Thank you. I am going to take prerogative for
a last question to Dr. Grazman. You raised in your opening
statement this issue about how current TSCA law inhibits the
ability to recycle. Many of us are very concerned about
recycling. Mr. Green's concerned about electronic recycling.
Recycling is a good thing, not a bad thing. How does current
TSCA law hurt recycling aspects?
Mr. Grazman. So if I took the byproducts from----
Mr. Shimkus. Pull the mike close.
Mr. Grazman. If we chose to just landfill, or get rid of
the byproducts from our process, there is no TSCA obligation at
all. When we choose to recycle, the TSCA obligations hit us in
their full weight. So, all things being equal, sometimes it is
easier not to recycle.
Mr. Shimkus. Thank you. We had that issue on ink and oil a
couple Congresses ago, and the EPA kind of addressed it
partially, but not fully, so that is an issue that we have
raised in this committee before.
Thank you very much. Now I turn to the ranking member, Mr.
Tonko, for 5 minutes.
Mr. Tonko. Thank you, Mr. Chair. This subcommittee has
heard at previous hearings that EPA's ability to require
testing of new and existing chemicals under TSCA has been
dangerously limited. TSCA requires any company planning to
manufacture or import a new chemical substance to submit what
is called a pre-manufacture notice. It is supposed to include
information such as the chemical identity, use, anticipated
production volume, exposure and release information, existing
available test data. According to EPA, 85 percent of the pre-
manufacture notices that agencies receive are accompanied by no
toxicity data whatsoever.
Dr. Sass, what kind of concerns does this raise for you?
Ms. Sass. Well, not having any information at all means
that EPA doesn't know how to move forward. It means that EPA
has very little power or ability to request that information.
There are restraints and constraints put on EPA in order to
move forward and collect that information. And I think it
burdens the agency unnecessarily. I think the burden should be
placed on the industry to provide the information that EPA
needs to do risk assessment, but previous to that, do a proper
hazard assessment.
Mr. Tonko. Thank you. For existing chemicals, Section 4 of
TSCA requires EPA to show that a chemical poses an unreasonable
risk before requiring additional testing. Dr. Paulson, how has
this requirement helped to undermine the law?
Mr. Paulson. This requirement basically has created the
non-evidence based system that I referred to, and industry is
basically penalized if they develop information in advance,
because then they are required to report it to EPA, and that
may adversely affect their bottom line. But with no reporting
requirement, and then no ability to request information because
you don't know there might be a problem, EPA is totally
stymied.
Mr. Tonko. Thank you. With any reform, we must make sure
EPA has adequate authority to require testing to protect human
health and the environment. In the Senate there is a proposal
to require EPA to categorize each chemical as either high
priority or low priority. Under that proposal, EPA would be
blocked from requiring testing on low priority substances.
My question, Dr. Sass, would that proposal increase testing
of the chemicals we are exposed to every day, or would it make
the problem worse?
Ms. Sass. I think it would make the problem worse. It would
hamstring EPA. It adds an additional catch-22 to EPA, because
it needs information to do an informed prioritization, and
without that information, it may miss many chemicals that are
very hazardous, and may be very important not only for hazard,
but also for exposure. It would miss that information, and then
it would not be allowed to go back and have the authority to
review the low priority chemicals, and, furthermore, at the
State level they may also be hampered. So those chemicals may
actually slip through what is not just a hole in the net, but
really the whole net just doesn't exist because of those
chemicals being able to fall through.
Mr. Tonko. OK. And, Dr. Paulson, what does the Academy of
Pediatrics think about blocking EPA from requiring testing on
these so-called low priority chemicals?
Mr. Paulson. Mr. Tonko, there does need to be a
prioritization system for sure, but the EPA needs flexibility
to move chemicals around, and any a priori blocking of chemical
evaluation would imply that we would never learn anything. So
if some miracle occurred, and new information came, the EPA
couldn't use that new information, so that just really makes no
sense. We have waited 40 years to modify this law. We should
not create more barriers with a new law that will take another
40 years to improve.
Mr. Tonko. Thank you. The recent West Virginia chemical
spill has brought this debate to life in many ways. The
chemical that spilled into the Elk River, spelled MCHM, was
shrouded in mystery. State and Federal officials had to
scramble to uncover the few health and safety tests that had
been conducted on that chemical. Dr. Sass, how did the lack of
health and safety data on MCHM hinder the CDC, and other
officials, when responding to that chemical spill?
Ms. Sass. The data for those chemicals didn't come out for
some time, and that created a concern, not only for public
health officials at the State and local level, to be able to
advise the community, and advise businesses about what to do,
but also for the population as a whole, for citizens. The CDC
was held back because it wasn't able to do the kinds of
calculations and evaluations that it needs to provide informed
and timely advice to the community. And, also, health officials
and first responders weren't able to get information rapidly.
They were having to advise and treat under a situation where
they were essentially blindfolded because of that situation.
Mr. Tonko. Thank you. I see my time is exhausted, so I
yield back.
Mr. Shimkus. The gentleman yields back his time.
The Chair now recognizes the chairman emeritus, Mr. Barton,
from the great Republic of Texas, for 5 minutes.
Mr. Barton. If only we were still a republic. You know,
that is water under the bridge. Well, thank you, Mr. Chairman,
and Ranking Member, for holding this hearing. I don't have too
many questions. My first question would be to Mr. Drevna, and
you might not know the answer. Do you know how many chemicals
right now are in the TSCA inventory?
Mr. Drevna. I am sorry, sir, I didn't hear you.
Mr. Barton. Do you know how many chemicals right now are in
the TSCA inventory? We talking hundreds of thousands, millions?
Mr. Drevna. Eighty to 100,000, I would imagine, if not
more.
Mr. Barton. OK. Anybody dispute that? Do you know how many
new ones are listed each year, approximately?
Mr. Drevna. I don't know, 700,000? Not 700,000, 700 to
1,000, something like that.
Mr. Barton. OK. I know this whole hearing is on testing and
disclosure, and then we have the issue of the animal testing,
but other than that, is there any major controversy on how
these new chemicals are tested?
Mr. Drevna. I believe that the testing for new chemicals is
pretty well established. Much as I criticize the EPA, they have
done a nice job, in my understanding, doing the new----
Mr. Barton. OK, let us go to the young lady. What is your
dispute with what Mr. Drevna just said about the----
Ms. Sass. There is very little testing done on new
chemicals, so EPA has issued some test rules, but it has been
on a very few number of chemicals. EPA is restrained in a
number of ways from issuing those test rules. There is timing
on those. There are authority limitations for EPA. There is the
requirement that it needs to actually find some hazard before
it can issue new test rules, that catch-22 that several
witnesses, including myself, mentioned. So, actually, it has
been very ineffective. There has been very few chemicals that
have been tested.
Mr. Barton. Now, is your complaint that the EPA has tended
to engage in what we call a voluntary procedure, as opposed to
the more complicated mandatory procedure? Is that a complaint,
or----
Ms. Sass. Well, it is a complaint in where it hasn't
worked. So there have been a number of voluntary initiatives
that have been larger, and there has been some information that
has been gathered from those, but not very much. So I would say
that they haven't been effective overall, and there have been
Congressional reviews that have shown that.
But at the chemical by chemical level, so as chemicals are
coming through the program, mostly, instead of EPA issuing test
rules, because they are very cumbersome, and because they can
be challenged, the EPA tends to negotiate with the company
about what test rules it will issue. I am not opposed to that,
so I am not complaining about that process, except where it has
held back on EPA from being able to issue the kind of test
rules that it needs to make a proper hazard evaluation.
Mr. Barton. Dr. Paulson, you raised your hand.
Mr. Paulson. I think that the voluntary programs have been
ineffective. They have produced very little in the way of new
information. The current legislation, and the judicial
interpretation of that legislation, effectively block the EPA's
ability to ask companies for toxicologic information on the
chemicals that they are introducing into the market. And that
results in playing catch up, where years later individual
scientists at universities do studies, and, lo and behold, we
find chemicals in human bodies that were never intended to be
in human bodies, and we find that those chemicals have adverse
effects on those human bodies. There are just numerous examples
of that.
Mr. Barton. Give me one example.
Mr. Paulson. Brominated flame retardants, perflorinated
chemicals, of which Teflon is one brand name. Those are two
examples.
Mr. Barton. And those chemicals were improperly tested, or
improperly used, or illegally used?
Mr. Paulson. None of the above, sir. They weren't
adequately tested before they were marketed. They were used in
ways that, presumably, industry thought was safe because they
themselves did not have the data to indicate that they were
getting into human bodies until later. And they didn't have the
data that they were harming human bodies until later. So I am
not suggesting any malfeasance here, it is just that, unless we
develop the data before the chemicals come on the market, we
are always subject to playing catch up.
Mr. Barton. My time did expire, and I want to thank the
panel.
Mr. Shimkus. I want to thank my colleague. I just want to
just follow up real quick on one of the answers. It is my
understanding the burden of proof is in Section 4, not Section
5, so we have got to be careful that we are conflating the
authority under this law. That is why, going through this
legislative process and our hearing is going to be very
difficult, because we found that this language is very tough.
So, with that, I would like to yield to my colleague, Mr. Green
from Texas, for 5 minutes.
Mr. Green. Thank you, Mr. Chairman, and I appreciate your
interest in e-waste, and hopefully we can have a legislative
hearing sometime so we can----
Mr. Shimkus. I am sorry, I am not hearing you.
Mr. Green. I am sorry. I can't imagine how hard it was in
1976 for Congress to do TSCA, and that is probably why, for the
last 38 years, it hasn't been revisited, because of the
complexity of it. My first question is, before a company
introduces something into a product, should there be some
minimum level of due diligence? Because, Dr. Paulson, you
talked about, the companies don't know. Should there be some
type of due diligence by that company, just to make sure that,
both for the folks producing that product, but also for the
consumers, that they should have that due diligence on the
toxicity of that product?
Mr. Paulson. Yes, sir, that should be the basic function of
any chemicals management policy, and we don't have that now.
Mr. Green. OK. We heard testimony today about how difficult
it is for EPA to make the required findings to require the
generation of additional information on chemicals under
existing provision Section 4. What additional authority should
EPA have to mandate the testing? Like you said, maybe we ought
to say there is a requirement by a company to do some basic due
diligence, and then EPA should have the authority to ask for
that information?
Mr. Paulson. Companies should be required to release
information to EPA. EPA should not have to ask for it. It
should be part of the process before a chemical goes on the
market that information goes to EPA. EPA is then able to
evaluate that information, and make a decision. We also have to
recognize that, even under the best of all possible
circumstances, chemicals will receive approval that later turn
out to be problematic, so EPA needs a mechanism to require
companies to do post-market surveillance, provide the
information on post-market surveillance----
Mr. Green. I understand that, and I have heard that, you
know, in any given day or week, at least in the last 38 years,
how many different chemical substances have been entered into
the market? Now, somewhere along the way, you know, if we have
literally thousands of companies, and for them to give that
information to EPA, and then to empower EPA to then go forward,
I agree that, you know, EPA should have the authority to
request that information and those testing levels. But I am
just wondering, you know, how big EPA would have to be to be
able to deal with the complexities of the market now. And I
know, from our manufacturers and our specialty companies, it
has got to be huge numbers of chemicals that are developed
literally almost every day. Can you all just give us an idea on
that?
Ms. Bosley. Well, EPA looks at 20 chemicals a week, 20 new
chemicals a week. That is their statistics. And beyond that,
industry develops other chemicals that don't go forward,
certainly. But the resources EPA needs to look at new chemicals
are very different than what they have been given to look at
existing chemicals. They have no mandate, really, to look at
existing chemicals, and, therefore, that is not where the
resources are spent.
Mr. Green. Well, and that is part of our concern. I want to
make sure, you know, our lifestyle has been built over the use
of these chemicals. And granted there are times, for example,
in West Virginia that nobody knew about that chemical. Even the
first responders didn't know how to deal with it. So we need to
deal with those, and that's the job of our subcommittee, to
come up with something that will do that. Drevna?
Mr. Drevna. Mr. Green, you are right. The thing about
Section 4, which we agree, to an extent, that the finding
requirement should be eliminated, but the hazard requirement
should stay. So, I mean, you could, in essence, limit the
number of chemicals that have to be looked at if you grant EPA
the authority for testing, but they have to still have a
component of that that says, wait a minute, there is a need out
there for an exposure and a hazard requirement. So that would
go a long way to remedying the situation.
And, I mean, there have been criticisms of TSCA because it
inhibits the EPA from collecting information, but there are
other statutes that come into play too. Administrative
Procedures Act, things like that. So look at it holistically
also. And, you are right, though, Mr. Green, we have got so
many, you know, large volume chemicals that they are
intermediates, that never really see the market.
Mr. Green. And, Chairman, I know I am almost out of time,
but also the low priority and high priority, obviously
something that is exposed vulnerable populations, should be a
higher priority even, you know, and so there is a way, I think
we can draft this, but it is not going to be easy, any more
than it was in 1976. So thank you, Mr. Chairman.
Mr. Shimkus. The gentleman's time has expired. The Chair
now recognizes the gentleman from Pennsylvania, Mr. Murphy, for
5 minutes.
Mr. Murphy. Thank you. I appreciate this panel. We are
learning a lot from all of you here. Mr. Drevna and Mr.
Matthews, I think, Dr. Grazman, you may have talked about this
too, about this whole prioritization process, how it works. And
I believe, Mr. Drevna, in your testimony you wrote that there
was not 80,000 chemicals, am I correct that was in yours, and
there are really only about 10,000? How do we prioritize the
safety of these in making some determinations? How do we set
these rules up? All of our concern is that which is not
forbidden is permitted, or that which is permitted is not
forbidden, and we want to make sure we do this right. How would
you recommend wording of this work?
Mr. Drevna. Well, I will go back to what I said earlier,
Congressman Murphy, tiered, targeted, and risk-based. If you
give EPA the authority through statute to use that kind of
mentality when addressing whatever chemical it is, whether it
is a high volume chemical, or whether it is something that is,
you know, a daily household product, if you do it tiered,
targeted, and risk-based, and understand what, you know, what
the hazards are, what the toxicity is, what the exposure is,
and that will go a long way to giving EPA the right tools to
address the situation.
Mr. Murphy. OK. Mr. Matthews, do you have anything to add?
Mr. Matthews. Well, I appreciate the doctor.
Mr. Murphy. We didn't want to write ``doctor.''
Mr. Matthews. Well, we agree, but let us be clear, the
impression shouldn't be formed that there isn't substantial
information on a lot of these chemicals that are in commerce,
including existing chemicals, not just new chemicals. EPA has
substantial information. It allows it to start to make some
judgments about which are the chemicals that should be first
put through a screening process, part of prioritization. What
we have said is, they have substantial information, but they
are missing a key component, and that is the use and exposure
related information. So we think that EPA can do a proper
screening process, even of the tens of thousands of chemicals
that are already out in the marketplace. They need to do that.
Make no mistake, this can't be done overnight. The numbers we
are talking about are substantial. But, in order to get to the
right choices first, they need not only the information they
have historically been receiving, but additional use and
exposure information, and start the process of getting through
these existing chemicals that have been on the market.
Mr. Murphy. Thank you. And, Dr. Bosley, can you explain the
importance of how you protect the chemical identity of
information that is submitted to EPA's----
Ms. Bosley. Certainly. So we in the chemical industry,
first and foremost, not one of us wants our chemical to cause
harm to human health or the environment. By the same token, we
live in the market reality, and we are faced with competitors
every day. For instance, my company, very, very small. My
competitors all know who I am. If I were to submit something to
EPA with the chemical identity revealed, they would know
immediately what sort of research I was doing, and, because my
markets are so limited, they would know exactly where that end
market would be. So it is not that I want to hide any hazard
information that I have. I don't. I want to send that all out,
but I would like to keep my chemical ID confidential. As long
as there is a robust generic name, such that the public, the
NGOs, and the EPA can all see what the generic name, and what
the hazard is.
Mr. Murphy. Thank you. Dr. Sass, I believe you, if I am
correct, are recommending we adopt some of the standards the
Reach program has in Europe. Do you think that would be more
effective for us to do that?
Ms. Sass. That wasn't in my testimony. Is that your
question?
Mr. Murphy. Yes, that is my question. Do you think that
would be----
Ms. Sass. Do I think it would be more effective? Well, I do
think it would be more effective to have harmonization, and the
other speakers have also mentioned that. I mean, having a
patchwork approach across continents, across countries, across
States, isn't any good for anybody. And I do think that the
approach we should use should be the highest bar to protect
human health and the environment. I think that not only saves
costs and liabilities for the produces, manufacturers, users,
and retailers, but also insurers in the healthcare. So, I mean,
the difference between having a cancer and treating it, and
never having had the cancer in the first place is huge, not
only on personal cost, but on economic cost. So I think
everybody has an interest in preventing problems. I think
everybody agrees to that. The difference is how we are going to
address them, and at what stage we are going to address them.
So I would support a system that would give the regulatory
agencies the authorities not only to have early comprehensive
and timely testing, but to make decisions on what they have.
Some of the other speakers have mentioned, and I agree, that we
have substantial data on a number of chemicals, and I think we
can take action on those.
Mr. Murphy. I know we are almost out of time, but, Dr.
Bosley, I would like you to submit also your responses to that,
in terms of how the Reach requirements would contribute, being
a big trade barrier for the United States.
I am going to also add this too. I was recently meeting
with a company in my district, Halgon Carbon. This little
bottle of granulated activated carbon is what is used in many
cases to clean up some of these chemical aspects. One gram of
this, and there are about five grams in a pack of sugar, has
more surface area than a football field. And I would hope that,
as we are looking at these TSCA issues too, that we include in
the whole package of analysis here not only what are the toxic
levels in some of these chemicals, but also the cleanup process
that would mitigate these things is a critically important
part, by which we take a chemical of concern to a chemical of
safety.
And with that I yield back, Mr. Chairman.
Mr. Shimkus. The gentleman yields back the time. The Chair
now recognizes the ranking member of the full committee, Mr.
Waxman, for 5 minutes.
Mr. Waxman. Thank you, Mr. Chairman. A number of today's
witnesses have testified in support of a risk-based approach to
chemical regulation, and I would like to explore this topic.
Dr. Sass, I would like to see if you could help us
understand what a risk-based approach means. To understand the
risk a chemical poses, EPA would have to need information on
both the hazard the chemical presents, as well as information
about exposure. Can you tell us what information EPA would need
to implement a risk-based system that the American people can
have faith in?
Ms. Sass. Well, sure. So EPA already does conduct risk
assessments on chemicals, and that means that it has both how
bad the chemical is, the hazard information, and what are the
chances, or probabilities, that you are going to be exposed to
it, the exposure information, and that is important. But,
earlier than that, EPA has to be able to collect both those
sets of information, and what this is trying to get at is
hazard. It is important to separate those out, because later,
when you make risk management decisions, they will take into
account exposure as well.
But, at this stage, doing a hazard assessment, it is
critical to focus on the hazard only. There are a number of
reasons why. For one thing, we have more of that data than we
do about exposure information. Exposure information is very,
very expensive, and difficult to get. I wish that the chemical
industry could give us the kind of exposure information that
they have all testified that EPA should have. But it is----
Mr. Waxman. Well, without this information, we wouldn't be
able to understand the risk a chemical presents, is that what
you are saying?
Ms. Sass. That is right. Half the equation would be gone.
We don't have that information.
Mr. Waxman. Dr. Paulson, do you agree?
Mr. Paulson. Yes, Mr. Waxman.
Mr. Waxman. I would like to turn to Mr. Drevna. In your
testimony, you suggested EPA should first make screening
decisions. That is, EPA should determine whether a chemical
should be a high priority or a low priority based on existing
information about what you describe as ``potential hazards and
exposures''. Are you recommending that EPA make decisions
without having actual information about hazards and exposures?
Mr. Drevna. No, sir, not at all. We are recommending----
Mr. Waxman. Is your mike on there?
Mr. Drevna. Yes, it was.
Mr. Waxman. OK.
Mr. Drevna. No, sir, not at all. We are recommending that,
you know, you can adopt a system, like the Canadians have
adopted, where you can have, you know, you rank chemicals, you
understand the molecular structure to most of them, you know,
and you can use current technologies to figure out, you know,
rank them, do the exposures. We are recommending that EPA have
the authority to ask for exposures under a new Section 8(a),
you see in my testimony. Absolutely, no, we are recommending
that----
Mr. Waxman. I appreciate that. So under the Senate
proposal, the screening level decision would be a very
important one, because once a chemical is designated as a low
priority, the chemical is shielded from further study and
review. Dr. Sass and Dr. Paulson, is there sufficient existing
information in most cases for EPA to determine that chemicals
are low priority, and shouldn't be subject to any further
scrutiny?
Ms. Sass. No, that concerns me. Determining something is a
low priority, or not hazard, should be a very high bar. For
example, the International Agency for Research on Cancer under
the World Health Organization has, I think, only one or two
chemicals in that category. It should be a very high bar to
actually put something aside and not look at it anymore from a
public health and environmental protection perspective.
Mr. Waxman. Is there sufficient information?
Ms. Sass. Without sufficient information.
Mr. Waxman. Dr. Paulson?
Mr. Paulson. No, sir. I think, particularly for new
chemicals, by definition, there is not sufficient exposure
information.
Mr. Waxman. Um-hum.
Mr. Paulson. And even for chemicals that have been around
for a number of years, there may not be bio-monitoring
methodologies that are available. There may not be
methodologies for measuring those chemicals in soil, or other
organisms besides humans. So, as Dr. Sass mentioned, exposure
information is often extremely limited.
Mr. Waxman. OK. Well, in Mr. Grazman's testimony, he
objects to EPA collecting certain information. For example, he
objects to the collection of information about worker exposure.
He also seems to object to reporting about the volume of each
chemical that is manufactured, and the consumer and commercial
uses of chemicals. Dr. Sass, this seems like important
information for understanding exposure. Can EPA evaluate
exposure, and therefore risk, if it doesn't have information on
how chemicals are used, and how exposure might occur?
Ms. Sass. You know, Mr. Waxman, you are exactly right. EPA
needs much more use and production, and also downstream use
information, and it needs to be able to update that information
in a timely manner as that chemical travels through commerce,
and has different----
Mr. Waxman. If we want EPA to make good decisions, then
that means we don't want them guessing. That means you can't
have both a risk-based system, and an unwillingness to provide
EPA with adequate information, is that your----
Ms. Sass. That is correct. I agree.
Mr. Waxman. And Dr. Paulson, would you care to comment on
this issue from a children's health perspective?
Mr. Paulson. While adult workers obviously aren't children,
they are often sentinels, and we need to be able to gather
information on worker exposure and use that information to help
understand, perhaps, either gaps that we need to fill about
children, or be able to extrapolate to children in the
instances where you can. So just in that one narrow area that
you are talking about, I certainly agree that blocking the
EPA's ability to collect and use that data will make it much
more difficult to make decisions about chemicals.
Mr. Waxman. And thank you, Mr. Chairman.
Mr. Shimkus. The gentleman's time has expired. The Chair
now recognizes the gentleman from Ohio, Mr. Latta, for 5
minutes.
Mr. Latta. Mr. Drevna, if I can again start with you, how
do you believe the coordination between the EPA and the TSCA
interagency testing committee has been?
Mr. Drevna. That is a good question. I mean, I really don't
know what they have done. I don't.
Mr. Latta. Have you heard anybody else talking about it? No
one? OK. Well, maybe we ought to check into that. Mr. Matthews,
if I could ask you currently, TSCA includes processes within
the scope of Section 8, and in your testimony you discuss how a
revised TSCA should expressly allow the EPA to collect
necessary use information from downstream processors. How does
this improve upon the existing construct? And then, just as a
follow-up, then, do all processors support the view? Do all
processors support this view?
Mr. Matthews. Well, OK, I mean, I am here to speak on
behalf of CSPA. I was at pains to say we are a segment of that
industry. One of the problems the EPA has is they have had
difficulty defining who a processor is. We circulated a 190
page document they created that attempted to define processor,
but in the end, it couldn't, so it is a very broad category.
And, coming back to your first question, one of the
problems, I think, is that EPA literally fears sending out an
information request or demand from ``processors'' because it
will produce more information than they can conceivably manage.
What we have proposed is a more targeted and focused
information flow of use and exposure information from that
segment of the processor community that we represent, which is
household and institutional products, which, during that
screening phase, during the prioritization phase, will actually
align with the kinds of issues that EPA is considering. And I
would go back to the questions that have been asked about
hazard, you still need hazard information, and there is
substantial information on hazard that has already been
generated, and EPA has its authorities in that regard.
But you would combine that with the kind of information
about exposures that EPA is concerned about, as it says, how do
we work through tens of thousands of chemicals in a logical
way? Which should be our priorities? And on that basis, the
kind of information that we would provide I think would go a
long way to answering those questions.
Mr. Latta. Thank you. Dr. Grazman, what is the EPA doing
with all this duplicative byproduct data that they are
collecting?
Mr. Grazman. That is a good question, sir, and I don't know
the answer. We have seen no evidence that they are doing
anything. And part of this, and it actually goes back to the
kind of--Mr. Waxman made quote in my written testimony, as I
mentioned, we are a manufacturer. We make our products through
a series of chemical and physical steps. None of the chemical
steps is perfectly balanced. Each one produces a byproduct.
And so right now, when I say we find it very difficult to
report to EPA the amount and nature of each byproduct, it is
because I have got 30 chemical processes that might use five
different chemicals that we buy, and then I have to understand
the amount of each component that is left over, how they may
react, and how any recyclers I send it to may process it. So if
you imagine that EPA is not only trying to handle the data from
chemical manufacturers, but from people like us, it truly would
be overwhelming.
Mr. Latta. Let me follow up. Even if these byproduct
manufacture were to be exempted from reporting, companies
manufacturing new chemicals from recycled byproducts would
still be required to report on the manufactures they are
manufacturing. Is that what would be happening, then, that they
would----
Mr. Grazman. Yes, sir.
Mr. Latta. Yes.
Mr. Grazman. The processors of our byproducts are reporting
on what they make out of them.
Mr. Latta. OK. Mr. Drevna, if I could go back to you, I was
kind of interested in what you were saying about Canada, and
about the model that they use up there. How would you rate the
model that they use in Canada?
Mr. Drevna. Congressman, I think it is one that Congress
should help EPA adopt. I think it is a good program. As one of
the witnesses says, it would help, you know, categorize. It
would help eliminate, and it is working for our friends to the
north.
Mr. Latta. And I know that Mr. Murphy had asked a question
a little bit earlier about this, or kind of touched on it, also
in your testimony I found it interesting that many people are
of the false impression that there are 80,000 chemicals in
commerce, and you say it is something less than 10,000. Where
did it ever come up that people thought there were 80,000?
Mr. Drevna. Well, I think once a chemical is out there on
the list, it never gets off, and there are so many
intermediates. It is a, you know, it is like the Hotel
California, you can come in, but you can't check out.
Mr. Latta. OK. On that Eagles note, I will yield back.
Mr. Shimkus. Showing your age. So thank you. Now the Chair
recognizes the gentlelady from the Denver Broncos, I mean from
the great State of Colorado, Ms. DeGette, for 5 minutes.
Ms. DeGette. Thank you so much, Mr. Chairman. And, in an
attempt to be bipartisan, I will say we are working together
very well on this TSCA reauthorization, and I am pleased that
we are having this hearing. There is a group of us on this side
of the aisle who really do want to work in developing this
legislation, as we discussed last night, and I am hoping we can
do it as it goes along.
I think there is consensus that some of the biggest
problems we have with the implementation of TSCA are rooted in
the procedure requirements under Section 4 for testing existing
chemicals, and so I want to focus on that during the first part
of my questioning.
Dr. Bosley, I wanted to ask you, yes or no, should the EPA
have to go through a rulemaking every time it needs data on an
existing chemical?
Ms. Bosley. No, absolutely not.
Ms. DeGette. And, Dr. Sass, what is your view on that?
Ms. Sass. No, it should not, I agree.
Ms. DeGette. OK. So it seems to me, I think everybody
pretty much agrees on this, one of the easiest ways to improve
TSCA would be to allow the EPA to request testing by order than
rulemaking, especially for existing chemicals where the data
probably already exists. Everybody is nodding, so, Mr.
Matthews, I am going to pick on you for a second.
I know you have got extensive experience providing counsel
to chemical companies, and I am assuming that chemical
companies, legitimate ones, like your clients, perform basic
testing of the products they sell in order to determine they
are safe. Is that right?
Mr. Matthews. Well, mind you, we are the downstream
purchasers of----
Ms. DeGette. OK.
Mr. Matthews [continuing]. Raw materials from upstream. It
is upstream where that actual testing of the chemical itself
takes place, but our companies go to great lengths to ensure
that the chemicals they put into their products are safe, so
they are----
Ms. DeGette. Right.
Mr. Matthews [continuing]. Looking at that data.
Ms. DeGette. So both the manufacturers, but your clients
too, they are not going to put those things on the market
unless they are pretty sure they are safe?
Mr. Matthews. That would be absolutely correct.
Ms. DeGette. And so both the downstream and upstream folks
are going to have information on file about the effects of the
products, right?
Mr. Matthews. I mean, I think often the manufacturers say
it is not readily ascertainable to us as to how it is being
used, and what kind of exposures are being created. So they
have some, but not enough, for EPA's purposes. That is where we
come in.
Ms. DeGette. OK. So what you said in your written testimony
is exactly that, very little information is readily available
to the agency on how chemicals are used in U.S. commerce in
order to fully inform prioritization, and to assess the human
health and environmental risk. That is exactly the point. So I
guess I would like it if you could just spend a second talking
to me about what you think about the current process of
rulemaking, and what could be done to help the EPA access this
information better. Would your clients agree with a different
system, and what would it be?
Mr. Matthews. Indeed we would. We would propose that there
actually be statutory changes that would address a more direct
and meaningful role of the downstream community that has----
Ms. DeGette. I mean, we are drafting the bill, so what
kinds of changes would you support?
Mr. Matthews. We would support a statute directing EPA when
it goes through this screening process, I mean, we are trying
to thread the needle here. They have to----
Ms. DeGette. Right.
Mr. Matthews [continuing]. Screen to get the prioritization
to get a list of substances that will go through a safety
assessment process. So, as they conduct that initial screening,
they have substantial information at their disposal. And we are
talking----
Ms. DeGette. So you would support them providing that
information to the EPA?
Mr. Matthews. I think the EPA generally has a lot of that
information, but yes, any updated information should----
Ms. DeGette. Without rulemaking?
Mr. Matthews [continuing]. From the manufacturers.
Ms. DeGette. Right.
Mr. Matthews. And now we would propose adding to that
provisions that would direct the agency to also, then, collect,
for the substances under review, use and exposure information
from the companies that have it.
Ms. DeGette. Great. Thank you. Now, Dr. Paulson, I want to
talk for a minute about the EPA authority, because, you know,
they have got 83 existing chemicals right now, so that is good,
but as the EPA studies those priority chemicals, science will
evolve, and we might know more about those chemicals that are
not on the priority list. So, Dr. Paulson, you support a
simpler process for the EPA to gather data. Can you just talk
briefly about how our understanding has evolved, and how
chemicals affect infants, children, and other vulnerable
populations?
Mr. Paulson. Yes, ma'am, thank you. Children have periods
of vulnerability from the time that really actually start
before conception, if we can understand that, conceptualize
that, and then, after conception, throughout pregnancy, and the
brain finally finishes developing somewhere around 25 years of
age, in terms of final myelination of coding of the nerve cells
in the frontal part of the brain. Likewise, the lungs continue
to develop until children reach whatever their adult height is,
so this is a process that takes many, many years, and damage
that is done before the process has finished, whether you are
talking about the lungs, or the brain, or the kidney, often is
irremediable. You don't get to start over or do-over in the
human body.
So data that is collected to make decisions on the safety
of chemicals needs to acknowledge these periods of
vulnerability, test around issues that pertain to these periods
of vulnerability, and then use that information in decision-
making.
Ms. DeGette. Thank you, Mr. Chairman.
Mr. Shimkus. The gentlelady's time has expired. I do look
forward to working with her, and if you check on 8(d), I am not
going to read this part, but part of that is in current law
too, and that is part of the problem of some of the things that
you asked about.
The Chair now recognizes the gentleman from West Virginia,
Mr. McKinley, for 5 minutes.
Mr. McKinley. Thank you, Mr. Chairman. Several of the
panelists, and some of the Members of Congress, have mentioned
and drawn attention back to the problem they had down in the
2nd District in West Virginia, down in the southern part of the
State. And I join with you in the disgust and the fury
internally I have over the breakdown of why that could occur.
So I am hoping that, from this hearing and elsewhere, we will
learn more, and not do a knee-jerk reaction, but we will try to
get this thing resolved. I know the Attorney General is looking
into it, and a series of others are looking into that.
But let me go back to Dr. Paulson, and some of your
remarks. In your testimony you said that, under TSCA Section 8,
companies are required to keep a file of allegations of
significant adverse reactions to human health or the
environment of any chemical they manufacture, and the companies
must also provide this information to the EPA upon request.
Now, I am just curious, given the MCHM issue of a discharge
into the Elk River, do any of you know, was there a request
that was denied about the MCHM?
Mr. Paulson. I am sorry, can you state the last part of
that question again? Just didn't quite hear you.
Mr. McKinley. Did the EPA, did they seek information about
this? Because that is what it says, companies must provide this
information to the EPA upon request. Did the EPA request
information about this chemical, one of two chemicals that was
discharged into the Elk River?
Mr. Paulson. In the post-leak time phase, I don't know,
sir.
Mr. McKinley. OK. Well, let us go just a little bit further
with that. Is there something more that they can do? Because I
heard a little bit ago you were saying, I think, in your
testimony that these things deal with confidentiality. I am
just wondering whether or not that was also an item that--was
it held back because of--or, Dr. Sass, do you know whether or
not either of these things has occurred?
Ms. Sass. So I do not know the specifics of conversations
that may have happened early in the spill between EPA and West
Virginia, but I think what the speakers had talked about, if I
am correct, referring to your question, is the idea that, if
there is an accident, or a spill, or an incident like this,
that it should be reported to EPA.
And the model, I think, is FIFRA 6(a)(2), which is the
pesticide model, so that if there is an incident, or a spill,
or a poisoning, that a report has to be made to EPA under FIFRA
6(a)(2), and that data is kept there, and that the obligation
to make that is the registrant, the chemical manufacturer in
this case. And that way EPA has a docket of these. And so
later, when EPA is reviewing those pesticides, which it does
every 15 years on a routine basis, and updates the science, it
can look and see if there has been a problem with fish kills,
with worker poisonings, child poisonings, things like that.
Mr. McKinley. How we can strengthen it, how we can make
this thing work better, because was this information even
available? That is what I am trying to find out about the MCHM,
was it out there?
Mr. Paulson. We do know----
Mr. McKinley. Because the first responders needed to know.
There was the delay in reporting. We have got to find out how
to make this thing better, and so I am looking under Section 8,
how we might be able to modify that.
Mr. Paulson. Well, we do know that the company, Eastman,
did provide some additional information, and I don't know
whether that was at the request of EPA, the agency for Toxic
Substances and Disease Registry----
Mr. McKinley. OK. So----
Mr. Paulson [continuing]. The West Virginia Department of
Health. So they did, in relatively short order, provide some
additional information. Then the Federal agencies needed to
analyze that, which, of course, takes time. I think that, had
this information been provided to the government before the
spill, there might have been a quicker turnaround.
Mr. McKinley. Well, that is what I am trying to find out,
is why it failed under Section 8, that they didn't provide that
information prior to this. That is what I am trying to find out
about.
But let me just close in the few seconds we have left that
I join with you in this concern about what happened down there,
and the need to work on TSCA. I am with you on that, as one of
just two engineers here in Congress. We need to work on this.
But I wish I could have seen the same fury from you all about
the situation in Bud, West Virginia. Bud, West Virginia, for
those of you that aren't aware, they have been without water,
this is their sixth month.
And for a community, Dr. Willett, you are only concerned
with the animal, where are they getting the water? Because it
is untreated. And these people, for six months, have gone
without water down in Wyoming County, West Virginia. Six
months. And I haven't seen anything in the headlines about
that. You know, people chasing that issue, take care of those
families, the children looking for water in their fountains,
and their school districts are closed. I know you don't have
jurisdiction over that, but I would think many of the advocates
out there in America would have raised this issue, that that is
not an acceptable way for a community to exist. They have to
rely for six months on bottled water.
Afraid my time is over.
Mr. Shimkus. The gentleman's time has expired.
The Chair now recognizes the gentleman from California, Mr.
McNerney.
Mr. McNerney. Did the gentleman yield?
Mr. Tonko. Mr. Chair, if I might, I think that that line of
questioning from our colleague is important, because it
highlights one of the failures of the existing law, in that it
didn't require the company to notify the EPA of the substance,
so vast improvements are required here.
Mr. Shimkus. I thank my colleague. I would just remind my
colleagues that there is Federal law called the Emergency
Planning and Community Right to Know Act, under which they
should have filed with the local first responders. The second
thing, under Section 8(e), is peril authority, and so is 8(c),
that this information should have been filed with the EPA. So,
having that, I will turn to Mr. McNerney for 5 minutes.
Mr. McNerney. I thank the Chairman. I just want to say, all
the testimony I have heard this morning was very constructive,
very positive, in terms of where we should be going, and I
appreciate that.
Dr. Paulson, in your testimony, you raised concern about
chemical companies claiming that important health and safety
data is confidential business information. Have CBI claims made
it difficult for key stakeholders to gain information about
potentially hazardous chemicals?
Mr. Paulson. To the extent that we don't know what is
included in the CBI claims, I can't answer that definitively,
but certainly that is a big concern. I think there is
information that should be available to the public that these
companies know, and they are making claims of CBI that lock the
public's right to know.
Mr. McNerney. Well, today the committee received a letter
from the Center for Environmental Health regarding today's
hearings on Sections 4 and 8 of TSCA. Mr. Chairman, I request
that this letter be made a part of the hearing.
Mr. Shimkus. Without objection, so ordered. I think we have
already seen it.
Mr. McNerney. Thank you. According to the letter, the
Center for Environmental Health, and I quote, ``is particularly
concerned with whether or not the EPA has enough data to make
appropriate designation for individual chemicals. Any revision
of TSCA must ensure that the EPA has adequate data to
demonstrate that the chemical truly has a reasonable certainty
of no harm before the agency deems the chemical to be a low
priority''. Then they go on to note that the law must require
chemical companies to submit minimum information sets in a
timely manner, equipping the EPA to evaluate new chemicals and
new uses of chemicals, and to evaluate chemicals for
prioritization.
Mr. Paulson, what is your biggest concern about what the
revision of TSCA might not do?
Mr. Paulson. My biggest concern is that a revision to the
Toxic Substances Control Act would not allow EPA to collect
sufficient data to make decisions. And they can't make good
decisions without good data. There need to be identified
minimum data sets that will collect information that pertains
to children and pregnant women, at least from my standpoint, as
a pediatrician. They are not the only groups that need
protection, but let me just talk as a pediatrician, and that,
unless any new legislation gives them that authority, gives
them the authority to request additional information when they
feel that it is necessary, and gives them the authority to
continue to receive information after a marketing decision has
been made, then we will all be right back here, talking about
problems with chemical management policy.
Mr. McNerney. Thank you. Dr. Sass, do you have additional
concerns about what the new legislation may not accomplish?
Ms. Sass. I think that my biggest, is actually that it
won't give EPA the authority to actually make a decision to
take action, that it will hold EPA in a holding pattern
forever, collecting information, and needing more information,
and waiting for information, and that would be sad, because
there are huge initiatives across all agencies to develop more
rapid and less costly testing. And I think that Dr. Willett had
mentioned some of these. We can start to do mixtures, we can do
formulations, we can look at interactions, different life
stages. There are some exciting new scientific data on the
horizon, the near and the far horizon. Computational toxicology
will be really exciting, and it would be a shame if EPA was
hamstrung in an old dinosaur science framework.
Mr. McNerney. Thanks. Mr. Drevna, what is your biggest
concern about what the new legislation may do?
Mr. Drevna. Two things, Congressman. One, we have to keep
in mind that this is a health and an environment statute, and
it is a commerce statute. And one of the things of a major
concern to us is Federal pre-emption. We would urge Congress,
in its revisit and rewrite of TSCA, to make sure that, you
know, as I said, that we don't, you know, inhibit the
manufacturing renaissance by having a patchwork quilt of kinds
of various State regulations. I mean, this is a statute that
calls for Federal pre-emption.
Mr. McNerney. Anyone else on the panel wish to answer that
question? What is your biggest concern about what the
legislation may do? All right.
With that I will yield back, Mr. Chairman.
Mr. Shimkus. The gentleman yields back his time. The Chair
now recognize the gentleman from Ohio, Mr. Johnson, for 5
minutes.
Mr. Johnson. Thank you, Mr. Chairman, and I too want to
thank the panel for being with us today. Let me start with Dr.
Willett and Dr. Bosley, if I could.
How do you respond to the call for a minimum data set on
all chemicals on the TSCA inventory, and why? Dr. Willett, you
go first.
Ms. Willett. I believe that our science and technology is
at the point where we can redefine what minimum data set means.
Mr. Johnson. OK. Dr. Bosley?
Ms. Bosley. I think that the general industrial chemicals
are not a one size fits all, and I think a minimum data set is
the wrong approach. I think that the data sets that EPA needs
should be based on the risk of the chemical.
Mr. Johnson. OK. For both of you, a follow on, is every
data gap a data need, in your opinion, and why?
Ms. Willett. That is a tough question. No.
Mr. Johnson. OK.
Ms. Willett. I think EPA should be allowed to figure out
which data gap is really a data need. They are, as I said, very
talented scientists and engineers there, and they know what
data they need.
Mr. Johnson. OK. Dr. Willett, a follow on for you. You
mentioned that a single two-generation reproductive toxicity
study requires at least $380,000, 2 years, and 2,600 rats. Is
this kind of test normal under a minimum data requirement?
Ms. Willett. It depends on the chemical sector, but it is a
common test that is required now.
Mr. Johnson. So it would be considered normal? OK. Mr.
Grazman, how are you today?
Mr. Grazman. Good, thank you, sir.
Mr. Johnson. How are things back in North Jackson?
Mr. Grazman. North Jackson is doing well.
Mr. Johnson. Good. Mr. Grazman, Section 9 of TSCA directs
the EPA to coordinate TSCA actions with actions taken under
other Federal laws to avoid unnecessary duplication. As a
manufacturer, are you aware of any steps that EPA has taken to
coordinate reporting requirements----
Mr. Grazman. No, sir----
Mr. Johnson [continuing]. Or processes?
Mr. Grazman [continuing]. We are not aware of any.
Mr. Johnson. You are not aware of any coordination----
Mr. Grazman. We have----
Mr. Johnson [continuing]. Done?
Mr. Grazman. We report, and for understandably good
reasons, to multiple divisions of government, and organs of
government, that ask for the data.
Mr. Johnson. OK.
Mr. Grazman. Whether it is the first responders in our
area, whether it is the environmental pluses of business, it is
everybody from our insurers, and our own shareholders, and our
own systems, so----
Mr. Johnson. Same data?
Mr. Grazman. Pardon?
Mr. Johnson. Same data?
Mr. Grazman. Yes.
Mr. Johnson. OK. Can you describe for the subcommittee the
environmental reporting that your company undertakes under
other laws? Now, you just mentioned a few of them, and how that
may overlap with reporting requirements under Section 8 of
TSCA?
Mr. Grazman. To do a complete job, I would really rather
follow up with you later and----
Mr. Johnson. OK.
Mr. Grazman [continuing]. That information.
Mr. Johnson. Yes, if you could get us that, that would be
great.
Mr. Grazman. Yes, sir, happy to.
Mr. Johnson. What steps does your company take to ensure
the responsible use, storage, and transfer of chemicals? What
laws, for example, regulate these activities?
Mr. Grazman. Every material that we bring in our factory is
evaluated for its safety in terms of its storage, its handling
to our workers, and its possible interactions with the other
chemicals that we use. Everybody from our insurance company to
the third party registrar of our environmental management
system audits our facilities against both the chemical and the
handling aspects of those things. We have customers doing
audits, because when a Department of Defense program is buying
their circuit boards from us, if our factory fails, potentially
they fail. So they are in making sure that our processes are
safe, and will provide a continued stream of products that they
need.
Mr. Johnson. OK.
Mr. Grazman. And then we have actually instituted a program
called layer process audits, where literally every day every
part of the factory is being looked at against checklists for
safety and efficiency.
Mr. Johnson. Are there any regulatory gaps that we should
worry about closing?
Mr. Grazman. I think the aspect of the regulation that
surprised us when we chose to start recycling, that we got hit
as if we were manufacturing chemicals. I would like to see that
closed, and I think that would also help EPA in reducing the
data they need so that they can focus on those that are
necessary for----
Mr. Johnson. OK.
Mr. Grazman [continuing]. Their effectiveness.
Mr. Johnson. Well, thank you for that.
Mr. Chairman, I yield back.
Mr. Shimkus. The gentleman yields back his time. The Chair
now recognizes my colleague from the State of Illinois, Ms.
Schakowsky, for 5 minutes.
Ms. Schakowsky. Thank you, Mr. Chairman, and to our panel.
I really apologize, I was at another hearing and couldn't come
and hear your testimony, but I do have a few questions.
As written, Section 4 of TSCA makes it extremely difficult
for the EPA to require testing of existing chemicals, but that
doesn't mean, as has been discussed, the chemical companies
never conduct any tests on these chemicals. They may conduct
safety testing for a variety of reasons, apart from any
requirement on TSCA. A company could conduct safety tests to
comply with the State law, to meet European requirements, if
you want to export, or a company may want to conduct testing to
assess potential tort liabilities.
So, Dr. Bosley, is that right, that companies may conduct
safety tests on a chemical for a variety of reasons?
Ms. Bosley. Yes. We conduct tests whether or not EPA asks
for them in general.
Ms. Schakowsky. And Mr. Matthews?
Mr. Matthews. Yes--are not doing the actual toxicity
testing, but they don't put a product on the market where they
haven't reviewed the toxicity of each of the chemicals they put
in those products.
Ms. Schakowsky. But the EPA and other health officials
often don't see these tests. As we have discussed also, Section
8 only requires chemical companies to immediately submit to the
EPA information they obtained that, quote, ``reasonably
supports the conclusion'' that a chemical, quote, ``presents a
substantial risk of injury to health or the environment''.
So, Dr. Paulson, in your testimony, you say that TSCA has
created a non-evidence based system for chemical management.
Can you explain what you mean by this?
Mr. Paulson. In medicine, in the latter part of the 20th
century, in the early part of the 21st century now, we talk
about practicing evidence based medicine, that the decisions
that we make should be based on rigorously collected
information to inform those decisions. So I have taken that
term that is used in medicine and applied it to a different
arena. And what I am suggesting here is that, in terms of new
chemicals, the companies are, in essence, penalized if they do
research, because they are required then to report that
research to EPA, and EPA might then use that research to make a
decision the company doesn't want made.
And, in terms of the chemicals currently on the market, the
quote that you just read, in terms of the definition of
substantial, that makes it very easy for companies to decide
that it is not substantial. And I think the standard should be
that companies need to disclose information that they have.
Ms. Schakowsky. Thank you. The recent chemical spill in
West Virginia, which you have also talked about, illustrates
the problems created when chemical testing data isn't widely
shared and available. On January 11 the Centers for Disease
Control told West Virginians that the water would be safe to
drink at one part per million of the chemical of concern, MCHM.
Four days later CDC said it obtained new animal studies leading
it to recommend that pregnant women not drink the water at all.
EPA told committee staff that the agency didn't have any
studies on the chemical. A week after the chemical spill was
discovered, Eastman, the chemical manufacturer, finally made
public the summaries of several safety studies.
Dr. Sass, how did this slow disclosure of the relevant
safety studies affect your ability, as a scientist, to assess
whether government was doing enough to protect public health?
Ms. Sass. Well, in the first few days, the public was
completely blindsided, and blinded, with no information. The
LD-50, the lethal dose that kills 50 percent of test animals,
which is very crude, and not the kind of test we want to use to
set a drinking water standard for a population, was the only
test that seemed to be available. I found it on an MSDS, or a
material safety data sheet. That is what CDC used initially.
Later they found a no effect test in rodents, a 28 day
rodent test, which they used. That is more informative. The
problem with that test is that only the conclusions of the
study were provided to the public, so there was no way to
analyze those data, or to re-analyze the data, or to confirm it
was a, you know, trust us, we are the experts type of study
from the industry, and that is wholly inappropriate for public
health agencies, first responders, scientists, and the public
to get any confirmation. So I think that it violated the public
trust, and it put public interest groups in a blinded position,
and it hamstrung the Federal agencies considerably.
Ms. Schakowsky. Let me just say that I think that it really
affected the confidence of the West Virginians, both in the
safety of their water, and in the government's ability to
respond.
Thank you, I yield back.
Mr. Shimkus. The g entlelady yields back her time, and we
want to thank you all. We think it was a great hearing. I want
to ask unanimous consent that all subcommittee members have 5
days to submit opening statements for the record. Without
objection, so ordered. Members will have 10 requisite days to
submit questions for the record, so if you follow up with
questions, if you would submit those back to us? I think it is
very, very important because, as you see, we had a lot of
active members very interested in this.
I think it is safe to say that there is need for reform
across the board. I think there is desire by the stakeholders
and members. I think also the status quo is really not
acceptable. I think people concur with that. Cautionary note is
don't let the perfect be the enemy of the good as we try to
work through this process.
And, with that, I want to thank my colleagues for
attending, and I will now adjourn the hearing.
[Whereupon, at 12:07 p.m., the subcommittee was adjourned.]
[all]