[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
TITLE I OF THE TOXIC SUBSTANCES CONTROL
ACT: UNDERSTANDING ITS HISTORY AND
REVIEWING ITS IMPACT
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON ENVIRONMENT AND THE ECONOMY
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED THIRTEENTH CONGRESS
FIRST SESSION
__________
JUNE 13, 2013
__________
Serial No. 113-54
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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 Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska ANNA G. ESHOO, California
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
TIM MURPHY, Pennsylvania GENE GREEN, Texas
MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado
MARSHA BLACKBURN, Tennessee LOIS CAPPS, California
Vice Chairman MICHAEL F. DOYLE, Pennsylvania
PHIL GINGREY, Georgia JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana JIM MATHESON, Utah
ROBERT E. LATTA, Ohio G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington JOHN BARROW, Georgia
GREGG HARPER, Mississippi DORIS O. MATSUI, California
LEONARD LANCE, New Jersey DONNA M. CHRISTENSEN, Virgin
BILL CASSIDY, Louisiana Islands
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia JERRY McNERNEY, California
CORY GARDNER, Colorado BRUCE L. BRALEY, Iowa
MIKE POMPEO, Kansas PETER WELCH, Vermont
ADAM KINZINGER, Illinois BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
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, Missouri HENRY A. WAXMAN, California, ex
JOE BARTON, Texas officio
FRED UPTON, Michigan, ex officio
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. Henry A. Waxman, a Representative in Congress from the State
of California, opening statement............................... 24
Witnesses
Kathleen M. Roberts, Vice President, B&C Consortia Management,
LLC............................................................ 4
Prepared statement........................................... 7
Charles M. Auer, Principal, Charles M. Auer & Associates, LLC.... 25
Prepared statement........................................... 28
Answers to submitted questions............................... 129
Alfredo Gomez, Director, Natural Resources and Environment,
Government Accountability Office............................... 50
Prepared statement........................................... 52
Answers to submitted questions............................... 134
Beth D. Bosley, President, Boron Specialties, LLC................ 76
Prepared statement........................................... 78
Answers to submitted questions............................... 138
Daniel Rosenberg, Senior Attorney, Health and Environment
Program, Natural Resources Defense Council..................... 85
Prepared statement........................................... 88
Answers to submitted questions............................... 145
Jeanne Rizzo, President and CEO, Breast Cancer Fund.............. 99
Prepared statement........................................... 101
Answers to submitted questions............................... 157
TITLE I OF THE TOXIC SUBSTANCES CONTROL ACT: UNDERSTANDING ITS HISTORY
AND REVIEWING ITS IMPACT
----------
THURSDAY, JUNE 13, 2013
House of Representatives,
Subcommittee on Environment and the Economy,
Committee on Energy and Commerce
Washington, DC.
The subcommittee met, pursuant to call, at 10:16 a.m., in
room 2322 of the Rayburn House Office Building, Hon. John
Shimkus (chairman of the subcommittee) presiding.
Members present: Representatives Shimkus, Pitts, Murphy,
Harper, Cassidy, Bilirakis, Johnson, Tonko, Green, DeGette,
Capps, McNerney, Barrow, and Waxman (ex officio).
Staff present: Charlotte Baker, Press Secretary; Jerry
Couri, Senior Environmental Policy Advisor; Kirby Howard,
Legislative Clerk; David McCarthy, Chief Counsel, Environment
and the Economy; Tina Richards, Counsel, Environment; Chris
Sarley, Policy Coordinator, Environment and the Economy;
Jacqueline Cohen, Democratic Counsel; Greg Dotson, Democratic
Staff Director, Energy and Environment; Elizabeth Letter,
Democratic Assistant Press Secretary; Stephen Salsbury,
Democratic Special Assistant; and Ryan Skukowski, Democratic
Staff Assistant.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. This subcommittee will come to order. I will
recognize myself for 5 minutes for my opening statement.
Today's hearing is on Title I of the Toxic Substances
Control Act: Understanding its History and Reviewing its
Impact. TSCA Title I addresses chemical substances and mixtures
in commerce. Title I gives EPA extraordinary authority to
regulate manufacturing and interstate commerce affecting
chemical substances and mixtures, from their manufacture,
processing and distribution in commerce, to their use and
disposal.
TSCA is not your garden-variety environmental law. To help
place the size and scope of it into context, the American
Chemistry Council estimates based on the Numerical List of
Manufactured Products prepared by the Census Bureau, more than
96 percent of all manufactured goods are touched by the
business of chemistry and the activities potentially regulated
by EPA under TSCA. Title I of TSCA has remained largely
unchanged for 37 years. Mr. Dingell has been here longer than
that, though most have not. Indeed, many of the nuts and bolts
of TSCA policy evolution have occurred outside the legislative
context.
Legislation recently introduced in the other body has
heightened interest in congressional action on TSCA. I, for
one, think we should closely examine TSCA and be open to
legislation to update and reform it. Any attempt to do so from
our end should start with fundamental oversight of how TSCA is
designed and operated. With many new members on this committee
and subcommittee, today's hearing is the first installment
towards that end.
Let us start by asking the following questions: What
authorities does EPA have under TSCA? What is TSCA's practical
legal reach? How many chemicals are currently in commerce? How
wide is TSCA's regulatory reach concerning chemicals in the
commercial universe? Which authorities is EPA using? Which
authorities is EPA not using? How do TSCA authorities relate to
one another and to other federal laws? What activities are
currently being carried out under TSCA? What parts of TSCA do
or do not work well? Are there legal gaps in TSCA? How does EPA
currently set an agenda for reviewing chemicals? Does it need
legal authority to do so? What is the history and extent of
information protection under TSCA? What are the issues that
come with it?
Thanks to our distinguished witnesses for joining us today
to help us get a better handle on what the law is, how EPA has
been implementing it, what it is like being regulated under it,
and where witnesses think its successes and failures lie.
I urge members to make every effort at this hearing to
learn the fundamentals of current law. That is the purpose of
today's hearing, rather than to argue for or against any TSCA
reform legislation.
I now yield 5 minutes to the ranking member of our
subcommittee, Mr. Tonko from New York.
[The prepared statement of Mr. Shimkus follows:]
Prepared statement of Hon. John Shimkus
Today's hearing is on Title I of the Toxic Substances
Control Act: Understanding its History and Reviewing its
Impact. TSCA Title I addresses chemical substances and mixtures
in commerce.
Title I gives EPA extraordinary authority to regulate
manufacturing and interstate commerce affecting chemical
substances and mixtures, from their manufacture, processing,
and distribution in commerce, to their use and disposal.
TSCA is not your garden variety environmental law. To help
place the size and scope of it into context, the American
Chemistry Council estimates based on the Numerical List of
Manufactured Products prepared by the Census Bureau more than
96 percent of all manufactured goods are touched by the
business of chemistry and the activities potentially regulated
by EPA under TSCA.
Title I of TSCA has remained largely unchanged for 37
years. Indeed, many of the nuts and bolts of TSCA policy
evolution have occurred outside the legislative context.
Legislation recently introduced in the other body has
heightened interest in congressional action on TSCA. I, for
one, think we should closely examine TSCA and be open to
legislation to update and reform it. Any attempt to do so from
our end should start with fundamental oversight of how TSCA is
designed and operated. With many new members on this committee
and subcommittee, today's hearing is the first installment
towards that goal.
Let's start by asking the following questions:
1.) What authorities does EPA have under TSCA?
2.) What is TSCA's practical legal reach?
3.) How many chemicals are currently in commerce?
4.) How wide is TSCA's regulatory reach concerning
chemicals in the commercial universe?
5.) Which authorities is EPA using?
6.) Which authorities is EPA not using?
7.) How do TSCA authorities relate to one another and to
other federal laws?
8.) What activities are currently being carried out under
TSCA?
9.) What parts of TSCA do or do not work well?
10.) Are there legal gaps in TSCA?
11.) How does EPA currently set an agenda for reviewing
chemicals? Does it need legal authority to do so?
12.) What is the history and extent of information
protection under TSCA? What are the issues that come with it?
Thanks to our distinguished witnesses for joining us today
to help us get a better handle on what the law is, how EPA has
been implementing it, what it's like being regulated under it,
and where witnesses think its successes and failures lie.
I urge members to make every effort at this hearing to
learn the fundamentals of current law. That's the purpose of
today's hearing, rather than to argue for or against any TSCA
reform legislation.
# # #
OPENING STATEMENT OF HON. PAUL TONKO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW YORK
Mr. Tonko. Thank you, Chair Shimkus. Good morning,
everyone, and thank you, Mr. Chair, for holding this hearing on
the Toxic Substances Control Act, better known as TSCA. I
understand the subcommittee will be holding additional hearings
on this program. I look forward to hearing from additional
witnesses on this very important topic.
We have all heard the stats related to chemical production
and use. Some 80,000 chemicals are in use with hundreds of new
chemicals coming into production every year. The advances in
chemistry and biology and the adoption of new manufacturing
processes over the past decade have shortened the time
necessary for development and manufacture of new chemicals.
There are many benefits to this progress, and some
challenges. The line between chemistry and biology has become
much less definitive. We should give some consideration to how
well current law is suited to evaluate new chemicals in light
of these new developments. This law has been with us now for
many years, enough years to provide us with ample experience of
its application and its utility.
The law has not lived up to expectations. It has not
provided a sufficient amount of information for the public
about the potential hazards of chemicals that they encounter in
their daily lives. There are many chemicals in commerce today
that have very little information about their potential risks
to human health or the environment. Some have none at all.
Successive Administrations have devised policies to reduce
the backlog of chemical assessments. None of these efforts have
been very successful. The law has also proven ineffective at
removing harmful chemicals from the market. Congress had to
take separate action to eliminate PCBs and asbestos when
mounting evidence demonstrated the problems with these
chemicals. It is not a good track record.
If we have safer alternatives to chemicals on the market,
the Environmental Protection Agency should be able to act in a
timely fashion to remove harmful substances, making way for
safer products to move into commerce. I am certain we will hear
about all of these issues this morning from our expert team of
witnesses.
I recognize there are several proposals introduced in the
Senate to amend this law. This hearing and the additional one
to come will provide us a solid base from which to evaluate
these proposals against current law.
I look forward to the testimony of our witnesses again here
today, and I thank you all for being here to share your views
on what is a very important topic.
With that, I yield back. Thank you, Mr. Chair.
Mr. Shimkus. The gentleman yields back his time. Is there
anyone else seeking recognition for an opening statement on the
majority side? Is there anyone seeking recognition on the
minority side? Seeing no one, we will then move to our panel.
We would like to welcome you all here. All your statements have
been submitted for the record. You will be given 5 minutes to
give your oral statement. We are not going to be punitive in
punishing but don't go too long because this is a large panel.
Just for your information, there is another committee hearing
going on on the first floor. Members will be coming up and down
for that. You are competing with the Secretary of Energy. You
can see where I am. Many members are down there trying to get
their licks in on him. Let me start by recognizing and
welcoming Kathleen Roberts, who is the Vice President of B&C
Consortia Management LLC. You are recognized for 5 minutes.
STATEMENTS OF KATHLEEN ROBERTS, VICE PRESIDENT, B&C CONSORTIA
MANAGEMENT, LLC; CHARLES M. AUER, PRINCIPAL, CHARLES M. AUER &
ASSOCIATES, LLC; ALFREDO GOMEZ, DIRECTOR, NATURAL RESOURCES AND
ENVIRONMENT, GOVERNMENT ACCOUNTABILITY OFFICE; BETH BOSLEY,
PRESIDENT, BORON SPECIALTIES, LLC; DANIEL ROSENBERG, SENIOR
ATTORNEY, HEALTH AND ENVIRONMENT PROGRAM, NATURAL RESOURCES
DEFENSE COUNCIL; AND JEANNE RIZZO, PRESIDENT AND CEO, BREAST
CANCER FUND
STATEMENT OF KATHLEEN ROBERTS
Ms. Roberts. Thank you, Chairman Shimkus, Ranking Member
Tonko, members of the subcommittee. I am here today to provide
a brief overview of the regulatory program under the Toxic
Substances Control Act, a TSCA 101, if you will.
I have spent more than 20 years with chemical companies to
understand and comply with TSCA. I was with the American
Chemistry Council for 17 years, and I have been with Bergeson
and Campbell for 4 years, where I work as a non-attorney
professional. As stated, I currently am Vice President of
Bergeson and Campbell's affiliate B&C Consortia Management. My
remarks today are on my own behalf and do not necessarily
reflect the views of Bergeson and Campbell, B&C Consortia
Management or any of their clients.
In my view, the regulatory process under TSCA is logical
and almost element in its simplicity. New chemicals must be
notified to EPA. This is a small, very simple flow chart trying
to show how they connect. New chemicals must be notified to
EPA. For any chemical on the TSCA inventory, EPA can gather
information through Section 8. If more information is needed,
EPA can require testing under Section 4. If there are still
concerns, EPA can apply necessary risk management controls
through Sections 5 or 6.
When TSCA was first enacted, companies informed EPA which
chemicals were produced or imported into the United States at
that time. This resulted in the initial TSCA inventory and was
issued in 1979. These chemicals are also often referred to as
grandfathered chemicals. Any chemical that was developed and
marketed after 1979 has gone through a New Chemical Assessment
under Section 5. This involves the submission of a
Premanufacture Notice that includes information on chemical
identity, description of byproducts, anticipated production
volumes, molecular formula, intended categories of use, and
other available information. EPA's decision options for PMN-
subject chemicals are: entry into commerce not allowed, entry
into commerce allowed with no restrictions, entry into commerce
allowed after submission of additional data, or entry into
commerce allowed with certain regulatory or testing actions
applied.
Assuming EPA has allowed the chemical to enter into
commerce, the manufacturer typically submits a Notice of
Commencement, and at that time the new chemical is added to the
TSCA inventory and becomes an existing chemical. All existing
chemicals, meaning all those listed on the TSCA inventory, are
subject to regulations under 4, 5, 6 and 8. There are other
sections of TSCA that also apply to existing chemicals but in
the brevity of time I will not try to go through all of them.
Section 8, as I mentioned, is focused on information
collection. Section 8(a) authorizes EPA to issue rules
requiring companies to submit information on categories of use,
quantities produced or imported, and/or health and
environmental effects. As of 2006, EPA has issued 33 8(a) rules
covering about 1,200 chemicals.
Also under Section 8(a) is the Chemical Data Reporting
Rule. This is an existing cyclical reporting cycle under which
manufacturers and importers are required to report production,
process and use information for chemicals manufactured or
imported over 25,000 pounds per year at a single site. The last
reporting cycle was in 2012, and information on about 7,700
chemicals was submitted. Section 8(c) requires companies to
record and retain allegations of significant reactions to any
chemical substance. If EPA issues an 8(c) data call-in,
companies are required to submit that information to EPA. Only
two such data call-ins have been issued.
Section 8(d) authorizes EPA to issue rules requiring
companies to submit lists or copies of ongoing and completed
unpublished studies. As of 2006, EPA has issued 51 8(d) rules
on about 1,200 chemicals resulting in about 50,000 studies
being submitted to EPA on a broad range of end points.
Under TSCA 8(e), entities are required to immediately
report information that reasonably supports the conclusion that
a chemical substance presents a substantial risk. As of 2006,
there were about 16,500 8(e) notices submitted. According to
EPA statistics, about 200 notices are submitted per year. EPA
can use the information collected or submitted under these 8(c)
provisions to identify whether a particular chemical is of
concern or if more information is needed. If that is the case,
EPA can use its Section 4 authority to issue test rules
requiring companies to conduct tests on certain chemicals. EPA
has required testing for about 200 chemicals under Section 4 or
under its enforceable consent agreement options. Keep in mind,
however, that as I have mentioned, EPA can require testing as
part of that new chemical review, and that has occurred for
about 300 chemicals.
Section 6 authorizes EPA to issue rules to manage risks for
existing chemicals. Risk management options include
restrictions on production levels, restrictions for certain
uses, restrictions on releases to environments, warning labels
and the like.
As noted earlier, under Section 5, EPA is authorized to
issue restrictions on new chemicals. They also can be applied
to existing chemicals pursuant to EPA's Significant New Use
authority. While only six chemicals have been subjection to
Section 6 requirements, EPA has applied restrictions to
thousands of chemicals through Section 5.
I would like to briefly highlight three challenges or three
areas that I think there may be some issues with. In my view,
EPA has been particularly constrained when trying to use its
TSCA authorities that require rulemakings. These challenges
aren't necessarily unique to TSCA rulemakings as I think all
rulemakings are fairly cumbersome and often take 3 to 5 years.
Likewise, while I see great output from EPA's New Chemical
Review process, there is less so in the existing chemical
arena. In my view, that may be because the new chemical
notification has a statutory review period of 90 days. There is
nothing similar in the existing chemicals program.
And finally, I would like to touch on the issue of
confidential business information as that is often raised as a
red flag for TSCA. Keep in mind that TSCA compels chemical
companies to provide a wealth of sensitive data. For example,
companies have to provide detailed information on how chemicals
are processed and manufactured. And while there are clearly
legitimate needs for EPA to have this type of information to
achieve its statutory goals, I believe there are also very
legitimate needs for companies to have that information
protected as confidential.
Thank you so much for this esteemed opportunity. I would be
pleased to answer any questions.
[The prepared statement of Ms. Roberts follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Shimkus. Thank you very much.
If the panel will hold for a minute, we welcome the ranking
member of the full committee, Mr. Waxman. Without objection, I
would like to allow him to give his opening statement. Then we
will return to the panel. It is always good to take care of the
ranking member of the full committee. So with that, I recognize
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 thank the
panel for allowing me to give my opening statement, even though
you have already started your presentations to us.
I want to commend the chairman for holding this hearing,
which begins our committee's work on the Toxic Substances
Control Act. TSCA is an important law because of its role in
protecting the American public from dangerous chemicals, and it
is long overdue for strengthening.
In recent years, EPA has undertaken a serious effort to
reform TSCA through the exercise of its regulatory authorities.
The Agency has formulated action plans for ten chemicals and
classes of chemicals, which are some of the most dangerous
chemicals on the market, and Agency deserves credit for those
efforts.
But EPA's authority is limited and progress has been slow,
even for the chemicals that are the worst of the worst. Four
years ago, there was widespread agreement among industry, labor
and nongovernmental organizations that TSCA needs to be
reformed. The EPA Administrator said that TSCA had proven to be
``an inadequate tool for providing the protection against
chemical risks that the public rightfully expects.''
The American Chemistry Council said it wanted to work with
``stakeholders, Congress, and the Administration to make reform
a reality.'' And a coalition of public interest groups said
that ``By updating TSCA, Congress can create the foundation for
a sound and comprehensive chemicals policy that protects public
health and the environment, while restoring the luster of
safety to U.S. goods in the world market.''
The Committee put considerable effort into building on this
consensus and modernizing TSCA. In 2009 and 2010, we held
numerous hearings and convened a robust stakeholder process. We
examined what testing should be required for all chemicals, how
information should be protected, and what safety standard
chemicals should be required to meet. While we made
considerable progress, we did not complete the job. And that is
why this hearing and the future ones to come are so important.
We need to hear from all stakeholders and work together, if
we can, to modernize this important environmental law. Even
with recent progress towards bipartisan cooperation, we have
significant work ahead of us to achieve that goal, but it is
certainly a worthy goal for this Congress.
I thank all of the witnesses for being here today. I look
forward to hearing your testimony. I want to apologize that I
am not going to be here the whole time because I have no
control over the schedule, and we have another subcommittee
meeting at the same time with the Secretary of Energy and I am
trying to be back and forth. If I am not here to hear your
testimony, I will probably be here to ask you questions about
your testimony because our staff has had a chance to review it
in advance.
Thank you, Mr. Chairman, for allowing me to make this
statement, and I yield back.
Mr. Shimkus. The gentleman yields back his time.
The chair now recognizes Mr. Charles Auer, Principal,
Charles Auer & Associates LLC, so you are recognized for 5
minutes.
STATEMENT OF CHARLES M. AUER
Mr. Auer. Thank you, Mr. Chairman. I thank you for this
opportunity to provide an oral summation of my written
testimony to this TSCA hearing--I do have a copy of the law. It
is very old, an original copy--before the Subcommittee on the
Environment and the Economy. I am pleased to be part of this
esteemed panel. I also appreciate and note the chairman's
statement of openness to reform. Thank you for that. Very
important.
As outlined in my testimony, I was a long-time EPA employee
who worked on TSCA issues for over 30 years. I am a chemist by
training, and at my retirement held the position of director of
the EPA office responsible for TSCA implementation. I left EPA
in early 2009 and now work as a consultant for a variety of
clients including companies, trade associations and others. I
note that my testimony is mine alone and that I am not speaking
for or on behalf of anyone else.
The first section of my testimony provides an overview of
TSCA's authorities, which Kathleen has nicely covered. The
second section reviews available statistics relating to various
TSCA provisions and attempts to describe the footprint of
regulatory and voluntary actions taken by EPA. The section
explores several sections including how many new chemicals have
been submitted to and been regulated by EPA. Available
statistics indicate that about 48,000 new chemicals have been
notified to EPA including as Premanufacture Notifications and
as regulatory exemptions under Section (5)(h)(4).
As I thought about my testimony, I came to several
realizations, and one of these is that over 15,000 new
chemicals have received some kind of regulatory action under
TSCA. I am sure this is news to most people in the room. This
includes action under Section 5(e) as a consent order, a
Significant New Use Rule, a section 5(h)(4) regulatory
exemption or a voluntary withdrawal action. I have included the
Section 5(h)(4) exemption chemicals in this list because the
exemptions process requires a grant or deny determination by
EPA and the chemicals are legally subject to the terms of the
exemption. One aspect that can be confusing is that the use of
the term ``exemption'' refers to a chemical being exempted from
the normal new chemicals process and instead such new chemicals
are subject to the exemption process. Note also that companies
choose to go the exemption route because it combines timeliness
and certainty. EPA will decide within 30 days, for example. And
EPA likes them because it produces an acceptable outcome
without a protracted negotiation. Voluntary withdrawals by the
company are included because this is often done in the face of
possible EPA regulation.
This set of 15,000 new chemicals regulated represents over
30 percent of all new chemicals submitted to EPA under TSCA,
and as I noted, this is an interesting statistic that I even
though I had been in the program for lo these many years had
not previously appreciated.
How many existing chemicals have been tested or were the
focus of risk management efforts? The story is not so good
here. About 200 chemicals were tested under Section 4, and a
small number, a very small number of chemicals were regulated
under TSCA in section 6 including PCBs. However, it is useful
to note, EPA has also used Section 5(a)(2), Significant New Use
Rule authority, in regulating over 300 existing chemicals
including PBTs, carcinogens and other toxic or risky chemicals,
and among those are some very well known bad actors. See my
testimony for details.
The third section discusses relevant TSCA sections with an
eye to exploring which aspects have worked or not worked. Areas
that I suggest have worked include the initial creation and
maintenance of the inventory, the new chemicals program and the
citizens petition process. The existing chemical programs on
testing and management are identified and discussed as areas
that did not work very well, although as alluded to in my
testimony, some very good outcomes have been obtained under
both Democratic and Republican Administrations. With that, let
me step back for a moment.
This is not a partisan issue although important principles
are at play. The issue is, however, complex, and that
complexity needs to be both recognized and be respected.
Getting it right is critical and essential to protecting health
and the environment while assuring the future competitiveness
of the United States. To achieve these goals, the final product
of any TSCA reform effort, in my view, must be workable and
effective for both EPA and the regulated industry. Back on
testimony.
With regard to legal gaps, I note that while Sections 4 and
6 may not rise to legal gaps in authority, although I suspect
others might differ, there is a need to strengthen and improve
these authorities. Concerning actual legal gaps, I point to the
need for implementing legislation if the United States is to
join treaties such as Rotterdam and Stockholm. I also suggest
TSCA revision to allow appropriate sharing with and receiving
of confidential business information from State and possibly
foreign governments that satisfy legal requirements. I note
that both Canadian and EU law allow for such sharing with other
national governments.
The fourth and last section reviews the history of EPA's
effort to set an agenda for reviewing existing chemicals, and I
attempt to answer the question: why haven't these earlier
attempts worked? I observed that a key issue is the way that
TSCA provides broad authority but vague priority to guide EPA's
work.
Mr. Shimkus. Sir, we need you to move a little bit quicker.
Mr. Auer. Further, I opine that EPA could do a better, more
effective job if it had appropriate policy guidance outlining
what among the various possibilities EPA should be doing. I
briefly elaborate on a series of underlying points. I also
recount that despite several attempts by EPA to create an
agenda over the decades, it has proven difficult for EPA to
figure the issue out on its own. In fact, it sometimes appears
that EPA is always initiating a new approach. See GAO's
testimony. And I take note of Mr. Tonko's useful comment in
this regard, which helps to make the case for one of the
central arguments in my testimony.
I respectfully note that Congress has not shown much
interest in TSCA over the statute's history. This is part of
the problem.
Mr. Shimkus. You are going to have to sum up.
Mr. Auer. All right. I will do my best. I mean, I think
this is important.
Mr. Shimkus. Well, why don't we just--we will go to
questions, and once you get asked questions.
Mr. Auer. Let me----
Mr. Shimkus. You are 3 minutes, almost 4 minutes over time.
Mr. Auer. I thought that was how much time I had left.
Mr. Shimkus. No. We have been overly compassionate here.
[The prepared statement of Mr. Auer follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Shimkus. We will pause here. We will move to our next
panelist and hopefully through the questions and answers we can
ferret out some of your other fine points that you want to
make.
So the chair now recognizes Alfredo Gomez, Director,
Natural Resources and Environment for the Government
Accountability Office. Sir, you are recognized for 5 minutes,
and maybe a minute or two over.
STATEMENT OF ALFREDO GOMEZ
Mr. Gomez. Mr. Chairman, Ranking Member Tonko, members of
the subcommittee. I am pleased to be here today to discuss
EPA's implementation of TSCA.
Tens of thousands of chemicals are listed with the EPA for
commercial use in the United States with an average of 600 new
ones added each year. Although chemicals are important in
producing goods and services, some may adversely affect human
health and the environment. Congress passed TSCA to give EPA
the authority to obtain more health and safety information on
chemicals and to regulate chemicals it determines post
unreasonable risks of injury, to human health or the
environment. EPA's authority is established in five major
sections of TSCA, some of which have already been discussed.
My statement today summarizes GAO's past work, describing
challenges EPA has historically faced in regulating chemicals,
and the extent to which EPA has made progress in implementing
its new approach.
I would like to begin by focusing on three of the biggest
challenges EPA has faced in implementing TSCA. First, under
Section 4 of TSCA, EPA has found it difficult to obtain
adequate information on chemical toxicity and exposure because
TSCA does not require companies to provide this information.
Instead, the law requires EPA to demonstrate the chemicals pose
certain risks before it can ask for such information. In June
2005, we reported that while TSCA authorizes EPA to review
existing chemicals, the statute generally provides no specific
requirement, time frame or methodology for doing so. We
suggested that Congress consider amending TSCA to provide EPA
explicit authority to enter into enforceable agreements
requiring chemical companies to conduct testimony and to
require chemical manufacturers and processors with substantial
production value to develop test data.
Second, under Section 6, EPA has also had difficulty
demonstrating that chemicals should be banned or have limits
placed on their production or use. We reported that since
Congress enacted TSCA in 1976, EPA has issued regulations to
ban or limit the production or restrict the use of only five
existing chemicals or chemical classes out of tens of thousands
of chemicals listed for commercial use. EPA told us that even
if EPA had substantial toxicity and exposure data and wants to
protect the public against known risks, the Agency's challenge
is meeting this statutory requirement under TSCA to limit or
ban chemicals.
Third, under Section 14, EPA has limited ability to
publicly share the information it receives from chemical
companies. While companies assert that their information is
confidential business information, EPA is limited from sharing
it with States and foreign governments. This potentially limits
the effectiveness of these organizations' environmental risk
programs. We reported that EPA had not routinely challenged
companies' confidentiality claims.
EPA has made some progress in implementing its new approach
to managing chemicals while results in other areas have yet to
be realized. For example, EPA has increased its efforts to
obtain chemical toxicity and exposure data and initiating
chemical risk assessments. However, it may take several years
before EPA obtains much of the data it is seeking. Moreover,
given the difficulty that EPA has faced in the past using
Section 6 of TSCA, since 2009 EPA has taken other actions that
may discourage the use of certain chemicals, some of which have
already been mentioned. However, it is too early to tell
whether some of these actions will reduce chemical risks.
Thus, it is unclear whether EPA's new approach will
position the agency to achieve its goal of ensuring the safety
of chemicals. EPA officials have said that the Agency's new
approach is summarized in its 2012 Existing Chemicals Program
Strategy. However, this strategy does not discuss how EPA will
address challenges associated with obtaining toxicity and
exposure data, banning or limiting the use of chemicals, or
identifying the resources needed. We recommended that EPA
develop strategies for addressing these challenges. In
response, EPA said that while strategic planning is a useful
exercise, absent statutory changes to TSCA, the Agency will not
be able to successfully meet the goal of ensuring chemical
safety now and into the future.
This completes my statement. I would be pleased to respond
to any questions.
[The prepared statement of Mr. Gomez follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Shimkus. Thank you.
The chair now recognizes Beth Bosley, President of Boron
Specialties, LLC. You are recognized for 5 minutes.
STATEMENT OF BETH BOSLEY
Ms. Bosley. Good morning, and thank you for inviting me
here today. I am the President of Boron Specialties. We are a
small fine-chemical manufacturer. We are passionate about
making our products here in the United States, and we currently
invest every dollar we make into accelerating our growth. We
are very small, only six people altogether. We are also
committed to responsible operation of our business including
environmental stewardship and regulatory compliance, very
important to me personally as a business owner. It is in the
spirit of running a globally competitive business while
protecting health and safety of our employees and the public
that I speak to you today about TSCA.
At the outset, I would like to make three general points on
my perspective on how to update TSCA. First, TSCA is a law
regulating chemical substances, not food, not drugs, and not
pesticides. TSCA gives EPA the regulatory authority to regulate
unreasonable risk to human health and the environment. It also
regulates a broad range of chemicals. Many of those chemicals
are industrial chemicals, and by that, I mean chemicals that
are sold between chemical companies but not necessarily part of
consumer products and not necessarily with any exposure to the
public.
The second point to bear in mind is the concept of risk.
Risk is a combination of two things. It is both hazard and
exposure, and one of EPA's jobs under TSCA is to do risk
assessments and to make judgments about whether reasonably
anticipated uses of chemicals would present sufficient
probability of harm to people or the environment, and if so,
then they are to restrict those uses.
Finally, smart regulation can and should achieve its
objectives without inhibiting innovation. American companies
like mine are on the cutting edge of chemical innovation. TSCA
has allowed us to lead the world in this regard. Any amendments
to TSCA must preserve time frames and flexibility but allow
this innovation to continue. They must also protect
confidential business information that is at the heart of all
innovation.
It is really easiest to look at TSCA in terms of existing
and new chemicals, and you have heard a little bit about that
already this morning. New chemicals are any that are not in
commerce currently, and prior to manufacturing those new
chemicals, companies like mine must submit what it is called a
Premanufacture Notice, or PMN, and submitted PMNs must provide
all the data that they have or that they can reasonably
ascertain about a chemical substance, and while it is true that
upfront testing is not required, EPA is able to employ
predictive technologies which interprets quite conservatively
to help decide if a new chemical raises concern. Through the
new chemicals program, EPA reviews roughly 2,000 chemicals
every year, and that really reflects the state of innovation in
the United States. It is also worth considering that new
chemicals are often greener than those that they are replacing
since minimizing a company's eco footprint is really a driver
for innovation.
Existing chemicals are those, as you have heard, that are
already on EPA's inventory. The inventory consists of chemicals
that were in commerce in the late 1970s plus the chemicals that
EPA has reviewed through the new chemicals program. It is often
referred to as over 80,000 substances. However, EPA's 2012
survey concluded that fewer than 8,000 chemicals are actively
in commerce, and that is defined as being manufactured at a
rate of 12\1/2\ tons per year at any single site in the United
States. While the current TSCA regulation grants EPA the
authority, the Agency has no mandate to assess existing
chemicals, as I think you have heard from every person on the
panel so far. Not surprisingly, non-mandated programs lose out
in the competition for budget resources.
Furthermore, when EPA does identify existing chemicals on
which it needs more data, it has to go through a time-consuming
rulemaking process to request testing, even when companies
might be in full agreement with that testing. EPA has developed
work-around mechanisms to collect the information that it
needs, and those are voluntary programs and consent agreements,
which industry participates in.
Section 6 authorizes EPA to restrict chemicals that present
an unreasonable risk, and this authority has seldom been used
and is at the center of the debate over TSCA. EPA's ability to
restrict existing chemicals that do not meet a safety standard
could be improved by eliminating some of these significant
procedural burdens. While this section certainly needs
improvement, and it is true that few chemicals have been
restricted under it, be mindful that chemicals may be regulated
under other sections of TSCA as well. As a matter of fact, most
chemicals can be and are used safely. This is why rather than
banning substances outright, EPA has opted to restrict their
uses instead.
The provision on confidential business information in
Section 14 has historically worked well to protect trade
secrets and promote innovation. However, many of the claims
have gone unchecked, creating a negative stigma around the
concept of CBI. Protecting information regarding chemical
identity and process technology are essential to maintain a
competitive edge for innovative U.S. manufacturers but there
are improvements that can absolutely be made to the CBI
process. And please bear in mind that EPA staff sees all
information, whether or not it is labeled as CBI.
As a specialty chemical manufacturer and a small business,
I can say unequivocally that protection of chemical identity
can be critical. Given the narrow application for which
specialty chemicals are used and the niche markets they serve,
disclosure of chemical identity may be all it takes to give
away a competitive advantage to an offshore manufacturer. The
majority of Freedom of Information Act requests to EPA come
from companies, many of which are overseas, not curious members
of the public. This Act underscores the real threat of losing
America's innovative advantage.
That concludes my oral testimony, and I would be happy to
take any questions.
[The prepared statement of Ms. Bosley follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Shimkus. Thank you very much.
Now the chair recognizes Mr. Daniel Rosenberg, Senior
Attorney under the Health and Environment Program of the
Natural Resources Defense Council. Sir, you are recognized for
5 minutes.
STATEMENT OF DANIEL ROSENBERG
Mr. Rosenberg. Thank you, Chairman Shimkus and Ranking
Member Tonko and members of the committee. Thank you for the
opportunity to testify today. It is good to see the committee
reengaging on this issue.
To be blunt, TSCA is widely recognized as a failure. It has
not enabled EPA to protect the public or even to assess the
risks the public may face from many commonly used chemicals. It
has not provided the confidence that chemical manufacturers
desire from their consumers and retailers. It is no wonder the
EPA, the GAO, scientists, health advocates, doctors and
business leaders are all calling for reform.
TSCA is riddled with fundamental structural flaws. Other
environmental laws, though controversial, have been fair more
effective. Perhaps the greatest original sin under TSCA was to
grandfather the 62,000 chemicals on the market in 1976. There
was no requirement for EPA to review those chemicals or to hold
them to any safety standard. In nearly 35 years, EPA has
managed to require testing of only about 200 of those
substances, and has partially regulated only five. That is a
problem because it means that chemicals that are known to cause
harm including cancer, learning disabilities and reproductive
problems in animals or humans remain in widespread use.
And many chemicals are in use for which we don't have
sufficient information to know whether or not they are safe.
This is a public health concern, particularly considering the
rising rates of cancer, mental illness and other chronic
diseases in our country. One in two men develop an invasive
cancer and one in four die from cancer--one in four men in the
United States. One in three women develop invasive cancers, and
one in five die. Roughly 1.5 million people in the United
States are diagnosed with cancer each year. The CDC just
released a study of mental illness in children and found 13 to
20 percent, 7 to 12 million, have mental health disorders
including ADHD, mood and anxiety disorders, and autism spectrum
disorders. Those rates are rising.
EPA's ability to fully assess and regulate chemicals is not
much better for the approximately 22,000 chemicals that have
been brought to market since TSCA was enacted. The law gives
EPA only a brief period--3 to 6 months--to review new chemicals
and makes it hard for EPA to get the needed data. Most
Premanufacture Notices are submitted to the Agency without any
data on health or environmental effects. EPA has taken steps to
fill the gaping holes in its authority and clear the high
hurdles set by the statute, but that is not an adequate
substitute for a protective system for reviewing new chemicals.
But even beyond timing and data requirements, TSCA stacks
the deck against EPA and public safety. The statute places the
burden on EPA to prove that a chemical poses a risk and then
sets a high threshold for making such a finding. This is
markedly different from other effective health and safety laws.
Makers of pharmaceuticals and pesticides have to show
affirmatively that their products are safe, and the food
quality law, the Food Quality Protection Act, that was passed
unanimously by a Republican Congress, had a more protective
risk or safety standard.
The experience with TSCA teaches the unsurprising but
essential lesson that laws without enforceable deadlines and
strong safety standards don't result in action and don't
protect the public.
The impotence of TSCA has left a vacuum that has been
filled by States and retailers. Nineteen States are currently
regulating chemicals with policies ranging from bans on
specific uses to disclosure requirements. This does not include
mercury product bans and other policies adopted in 34 States to
limit exposure to mercury. In addition, large retailers have
stopped stocking some products or excluded chemicals from their
supply chains. While these important actions have increased
public protection in a piecemeal fashion, they are a
supplemental but are no substitute for a working federal
system. States and retailers have had to act, though, because
of mounting scientific evidence and increasing public concern.
Scientists know more about the impact of chemicals than in
1976. There are greater concerns now about the effect chemicals
can have on our endocrine system and about the potential
impacts of even small doses of certain chemicals. We also have
more information about ongoing exposure of hundreds of
substances due to the development of biomonitoring. The public
understands this.
NRDC has commissioned a number of polls to survey public
opinion on the question of chemical reform. In both our poll
and those of others, we see strong public support for real TSCA
reform. Among the findings of our national poll, which is about
a year old now, over two-thirds of voters, 68 percent, support
``stricter regulation of chemicals produced and used in
everyday products.'' This support cuts across every political
group including majorities of GOP voters--57 percent;
independence--66 percent, and Democrats--79 percent. The
support was even stronger for specific legislation to reform
TSCA. A description of legislation that would require all
chemical manufacturers to show that their chemicals are safe in
order to sell them and that EPA would be able to limit some or
all uses of a chemical that may harm public health or the
environment yielded 77 percent support with 50 percent strongly
supporting. Support, again, cut across all political, ethnic,
gender and regional lines. This is an issue where Washington is
way behind the people it represents.
I think TSCA's one clear success has been the phase-out of
PCBs that was mandated in the original law in 1976.
Representative Dingell led the fight to include the PCB
provision in the law, and while PCBs are still very much with
us and in us, it at least did what the title of the law
promises: it controlled a toxic substance.
Congress should learn from that vision and take steps to
really repair TSCA and protect the public, for example,
requiring the phase-out of other persistent bioaccumulative and
toxic PBT chemicals. There are many ways in addition to phasing
out PBTs to reform TSCA in a way that protects the public and
also allows the chemical industry to thrive and innovate. We
would welcome the chance to work with the committee and all
interested parties to develop such reform.
Thank you very much for the opportunity to testify.
[The prepared statement of Mr. Rosenberg follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Shimkus. Thank you.
The last person on the panel is Ms. Jeanne Rizzo, President
and CEO of the Breast Cancer Fund, and you are recognized for 5
minutes.
STATEMENT OF JEANNE RIZZO
Ms. Rizzo. Good morning. Thank you, Chairman Shimkus and
Ranking Member Tonko and the members of this committee for the
opportunity to testify and to bring a public health perspective
to this panel and discussion today.
At the Breast Cancer Fund, we work to prevent breast cancer
by eliminating exposure to toxic chemicals and radiation linked
to the disease. So I am here today on behalf of the 3 million
breast cancer survivors who are living in this country at the
moment, 40,000 women and, increasingly, men who will lose their
lives to breast cancer this year, and I am also here on behalf
of the millions who are suffering from diseases and conditions
that have been linked to chemical exposure--birth defects,
asthma, early puberty, learning disabilities, infertility,
cancers including breast and prostate--and I am here to state
from our perspective that in no uncertain terms, the 1976 Toxic
Substances Control Act is hurting us. As a matter of fact, it
is killing us but not protecting us, and we have manifestation
of that in the fact that there are chemicals that are
transferring into our bodies, into our food, our water, our air
and even into the umbilical cord of babies.
That is not what Congress intended back in the 1970s when
the country was grappling with the public health disaster
wrought by better living through chemistry. That paradigm, the
attempt was to fix that. There was really good intention, and
disease rates were skyrocketing. Scientific evidence was
mounting. Congress knew then as it does now, I believe, that it
had to act. So it passed TSCA with great hope that that
legislation would indeed protect public health. We now, as you
have heard, have had 37 years of proof that the legislation has
failed us.
Look at breast cancer today. Two hundred and twenty-seven
thousand women will be diagnosed with breast cancer this year,
and 2,200 men. Women have a one-in-eight lifetime risk of
breast cancer. That is a 40 percent increase since TSCA's
passage. We know that only 5 to 10 percent of breast cancer can
be traced back to inherited genetic factors. There is a
volcanic amount of scientific evidence that points to
environmental causes including chemical exposure. We know that
our genes and our environment collude together to result in
positive or negative health outcomes.
We now have to acknowledge TSCA's failure and figure out
how to design that better, like the fact that the 84,000
chemicals that are in the TSCA inventory, the 62,000 that were
grandfathered in. We heard a lot about that today. So chemicals
could continue to be sold without having to be looked at for
their long-term impact on health and the environment. The EPA
under TSCA has only been required to test a certain number of
those grandfathered chemicals. They have only been able to
restrict or ban five of them. If TSCA makes it so difficult to
regulate a chemical that the EPA couldn't even ban asbestos, a
very well-known carcinogen with a disease named after it, then
clearly we have not accomplished the goal.
So we have to take seriously our new knowledge that timing
of exposure to chemicals matters, that low dose of chemical
exposures matters, and that mixtures matter, and that is our
real-life experience. So there is emerging science, the growing
consensus that TSCA must be reformed.
In my written testimony, I refer to three major federal
reports that I encourage reading as well as the 2009 GAO report
that talked about the fact that although TSCA is authorized to
ban or limit chemicals, the threshold is prohibitively high.
And we see States around the country, as you have heard before
today, taking action. They feel they have the right and the
responsibility under their 10th amendment to protect and police
the safety of their residents, and they are doing that, and
that is creating the kind of action that is protecting people
in some States but not in all States.
So we have a growing chorus urging Congress to strengthen
the way we regulate chemicals and the way the American people
are protected from those chemicals. We even hear businesses
want that protection. So the women of this country are looking
to you for your leadership. People in our military, our armed
services, want assurances that their military bases will not be
contaminated as Camp Lejeune was. People in polluted
communities want to know that action will happen and that
workers are safe. Parents want to know their 6-year-old
daughters will not enter puberty and have a later lifetime risk
of not only breast cancer but social, sexual issues, drug abuse
as well as high-risk behavior. So our children and our
grandchildren want to know that they won't face that burden.
It is a burden then for Congress to take on the awesome
responsibility of dealing with TSCA in an urgent manner with
safety standards, the best available science, data on all
chemicals, the ability to act on the worst, the right to know
reasonably and responsively navigated and maintain the States'
rights to protect citizens in the absence of federal action.
Thank you very much.
[The prepared statement of Ms. Rizzo follows:]
[GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
Mr. Shimkus. Thank you.
Mr. Auer, I am going to start with you and so I will give
you that opportunity. Your testimony mentions that you consider
the combination of ``unreasonable risk'' and ``the least
burdensome requirement,'' which is what we are going to talk a
lot about over the next couple months, in TSCA to be largely
unworkable. From an intuitive standpoint, it makes a lot of
sense to me that regulation should not be more than appropriate
and necessary to address the risk. Do you agree?
Mr. Auer. Yes.
Mr. Shimkus. Is your concern with the wording suggesting
extreme analysis?
Mr. Auer. Yes. The least burdensome and the way that it has
to be squared with the to extent necessary to protect against
the risk standard, I believe makes it unworkable, or largely
unworkable.
Mr. Shimkus. Since you agree that it makes sense that
regulation should not be more than is appropriate and necessary
to address the risk, do you think there is a role for the basic
concepts that underlie least burdensome to be included in
future chemical legislation?
Mr. Auer. Yes. The concept needs to be included per my
previous response. We will need to take care with the wording
to ensure that it does not become a straitjacket, however.
Thank you.
Mr. Shimkus. Ms. Bosley, the same to you. Do you think TSCA
should have a least burdensome requirement for regulations?
Ms. Bosley. Certainly. I think that that is helpful for
small businesses, especially like mine, but it should be much
more workable than it is today.
Mr. Shimkus. How would you have it operate?
Ms. Bosley. So right now, EPA has to discover all the
avenues themselves and then decide between the least
burdensome. That is a lot of analysis. I think if you opened it
up to public comment and let the public and industry and NGOs,
give them the options which are out there, then they can decide
among those which are least burdensome.
Mr. Shimkus. How easy is it to have a chemical's production
stopped or curtailed in the early going?
Ms. Bosley. Oh, it is much easier in the early going. If we
are going to fail, we would rather fail early before too much
investment has been spent. So we very much appreciate when EPA
tells us before a chemical is in full production that they are
going to regulate it.
Mr. Shimkus. And how critical--and you mentioned this in
your opening statement, but can you again talk about how
critical it is to your business for the protection of
confidential business information and what do you believe that
the public should be entitled to?
Ms. Bosley. Sure, sure. So especially for new chemicals and
once again for small businesses like mine, our chemicals and
our uses are very focused and so our competitors, mostly
offshore competitors, know what we are doing, and if we are to
put in a PMN, Premanufacture Notice, with chemical identity
right out there, then they know what we are researching, which
gives them a leg up on us. They are just a lower burden in
other countries. So I think protection of CBI is very
important. I know that it has been overused, though. I used to
work for people who would check every box as CBI on a PMN, and
that is much overused. I would be happy if there was upfront
substantiation and re-substantiation maybe every 5 years but
the initial protections are very, very, very important.
Mr. Shimkus. And Mr. Gomez, when your testimony refers to
characterizations about EPA's inability to meet its goal of
ensuring the safety of chemicals, does this mean that chemicals
are unsafe or that EPA is having an administrative problem
prioritizing chemicals and reviewing them under the law?
Mr. Gomez. So just to clarify, in our testimony we make
characterizations about EPA's efforts to manage toxic chemicals
consistent with the agencywide strategic goal of ensuring the
safety of chemicals. We didn't evaluate whether chemicals were
unsafe so we were looking again at the new approach that EPA
has in place and the different things that they are doing and
then we are drawing questions about whether they are going to
realize the results that they have taken on.
Mr. Shimkus. Thank you. Mr. Auer, the Government
Accountability Office and Mr. Rosenberg have been critical of
TSCA and EPA's implementation of it for almost 30 years from a
quantitative standpoint. Do you believe that only looking at
the program from this view is appropriate?
Mr. Auer. I do believe you need to take a broader view.
TSCA tools can be hard to implement and use in a regulation.
There are many important voluntary efforts, the high-production
volume challenge program, the PEFO, a stewardship program, use
of SNURs to regulate PBTs, the flame retardant tris and other
very well known chemicals. I do believe you need to take a
broader view. On the new chemicals, you need to look at what
EPA stops as well as the effect of EPA encouraging the industry
to go in the direction of safer and greener chemicals.
Mr. Shimkus. This is a great panel. Thank you very much.
And now I will yield 5 minutes to the ranking member, Mr.
Tonko, for 5 minutes.
Mr. Tonko. Thank you, Mr. Chair.
Mr. Gomez, you identified three main challenges for TSCA
implementation in your testimony. First, the fact the Act does
not require companies to generate or provide adequate
information on chemical toxicity and exposure to EPA. Can you
elaborate on what the obstacles are to getting that
information?
Mr. Gomez. Sure. So we noted that EPA has had difficulty
obtaining adequate information on chemical toxicity, and the
reason being that TSCA does not require that companies test
chemicals before they are manufactured. TSCA requires EPA to
demonstrate that chemicals pose certain risks before it can ask
for such testing.
Mr. Tonko. OK. And Ms. Rizzo, what are the public health
impacts and specifically the impacts on cancer risks from the
lack of information that you cited?
Ms. Rizzo. Thank you. There have been several reports
issued. The President's panel on cancer and the environment,
the national conversation on chemicals and public health as
well as a recent federal advisory committee on breast cancer
and the environment, an interagency committee of 21 scientists,
academics, agency people, that got together to look at this
issue of the impact of chemicals and cancer, breast cancer in
particular, not just looking at those that are named
carcinogens but endocrine-disrupting chemicals. They really
have an impact in utero, in early childhood, in puberty, during
lactation to trigger cells to believe that they have been
exposed hormonally and to react accordingly, increasing the
risk of breast cancer. We see this in animal studies and we see
it in the human manifestation of the increase in breast cancer
and other hormonally related cancers.
Mr. Tonko. Thank you. Mr. Gomez, the second challenge you
identified is that even when EPA has obtained information about
the risk from chemicals, the Agency has had difficulty banning
or limiting the production or use of those chemicals. Can you
explain why this happens to be the case?
Mr. Gomez. Sure. So we have noted that EPA had difficulty
proving that chemicals posed unreasonable risk and has
regulated few chemicals under TSCA. EPA has a high legal
threshold to meet so EPA must demonstrate unreasonable risk,
which EPA tells us that they believe that it requires them to
extensive cost-benefit analyses to ban or limit chemical
production. And so as I noted, since 1976 only five existing
chemicals have been controlled. We have previously recommended
that Congress amend TSCA to reduce the evidentiary burden EPA
must meet to control toxic substances and continue to believe
that such changes are warranted.
Mr. Tonko. Thank you. Mr. Rosenberg, what are some of the
environmental and health impacts of this inability to ban or
limit these chemicals?
Mr. Rosenberg. Well, you are faced with ongoing exposure
both in the health and the environment to all kinds of
substances, particularly I mentioned PBTs, things that persist
in the environment and bioaccumulate into our bodies, so those
are, by definition, around for a long time, and as long as they
are not controlled, more are produced, more are released into
the environment, not just in the environment like out in the
forest but in our homes and, you know, our workplaces and
places we are. So if you are not controlling the exposure to
the substances of concern and they are still being
manufactured, even if they are not still being manufactured,
they might still be in products. Once they are in there, they
can get out of the products, whether during the natural life of
the product, as it were, or during disposal or at other times.
Mr. Tonko. Thank you. Ms. Rizzo, who bears the worst
effects of these avoidable hazardous exposures?
Ms. Rizzo. I am sorry, sir. I didn't hear that.
Mr. Tonko. Who bears the worst effects of these avoidable
hazardous exposures?
Ms. Rizzo. Well, I think there are vulnerable--those that
are most vulnerable amongst us. We see it for children, we see
it for women, we see it for communities that are
disproportionately affected because of where they live, what
their legacy exposures are to these toxic chemicals. So you see
people that live on toxic dump sites, essentially, you know,
their build environment didn't consider their chemical
exposure. You see it in poor people whose access to healthier
foods, healthier products is just not there so they are going
to get more exposure through whether it is personal care
products they use or the air pollution, the freeway they live
next to, the water that isn't as safe and as healthy. So I
think if we look at breast cancer, there is a dramatic
increased risk in premenopausal breast cancer amongst African
American women, so the vulnerable populations need the greatest
protection.
Mr. Tonko. Thank you. I note, Mr. Chair, my time has
expired so I will yield back.
Mr. Murphy [presiding]. Thank you. I will now turn to the
gentleman from Pennsylvania and chair of the Health
Subcommittee, Mr. Pitts, for 5 minutes.
Mr. Pitts. Thank you, Mr. Chairman.
Ms. Roberts, some argue that TSCA does not encourage green
chemistry. Does the TSCA structure discourage U.S. companies
from innovating, including the creation of green chemistry?
Ms. Roberts. Thank you for the question. No, I don't
believe TSCA discourages development of green chemistry. In
fact, I think as Ms. Bosley had mentioned in her testimony,
given the way that Section 5 new chemical notification
processes are set up, U.S. companies can develop new chemicals,
have them reviewed by EPA and get them to market faster, and
that ability to innovate in particular helps those companies
that are trying to develop greener chemicals and get them on
the market. So absolutely, I think that the way the TSCA
framework is set up right now, it in fact is encouraging of
innovation. I don't have the numbers in front of me but I do
believe that there have been reviews showing that U.S.
companies have higher patents on chemical products, on polymers
and the like, again showing and proving that U.S. innovation is
stronger than an other parts of the world.
Mr. Pitts. We hear a lot of claims about chemicals not
being tested, Ms. Roberts. Is there a requirement for new
chemicals to have test data provided to EPA before they hit the
market?
Ms. Roberts. It is a very interesting question. Actually,
there is not a requirement for new chemicals to be tested
before they go on the market although, again, as Ms. Bosley
mentioned, there is a requirement if data is available that it
be submitted with the PMN. But EPA has developed a very useful
and scientifically sound program where they have predictive
models where they look at molecularly similar chemicals and
they can make judgments on how an analog chemical would act so
they can make some considerations of hazard exposures or hazard
profiles. They can look at the information that is included in
the PMN and determine how this particular material might be
exposed to the general public or releases to the environment.
EPA staff must be given great kudos because they have taken
these models that they use internally and they have made them
available to companies so that companies can use these models
and determine whether there are going to be issues of concern
with chemicals before they even send them to EPA for market,
and again, I think that helps companies pursue those areas
where they are going to be developing safer and greener
chemicals.
Mr. Pitts. Thank you. Mr. Auer, are many new chemicals
safer and greener than their chemical predecessors?
Mr. Auer. That is my personal opinion and experience. I was
the chair of the Structure Activity Team in the new chemicals
process for over a decade. I have seen thousands of new
chemicals. I know what they are competing against. My personal
view is yes. There has also been some EPA work showing that
these structure activity predictions can work effectively. The
chemicals are also more energy efficient, more product
efficient. Oftentimes they substitute for known toxic
chemicals. So as elaborated in an annex to my testimony, I
believe that the New Chemicals Program has been very effective
in encouraging the development and introduction of safer and
greener new chemicals.
Mr. Pitts. To follow up, the EU with more demanding
requirements to market entry has seen dramatically fewer
numbers of new chemicals introduced into commerce than the
United States. Are these U.S. chemicals more risky than the EU
chemicals?
Mr. Auer. You know, my guess is they are pretty much the
same chemicals. I am sure some are unique to the United States
or the EU but my guess is, most are the same, and as elaborated
in my annex, looking at the same period of time and the same
rules, if you will, the EU with a base set saw 3,000 new
chemicals introduced. The United States saw 17,000--maybe my
numbers are wrong--six times as many over the same period in
time. I believe that is a profound driver for innovation, given
the safer and greener answer I gave previously.
Mr. Pitts. Thank you. Mr. Gomez, some argue that companies
overclaim confidential business information under TSCA. Is it
EPA's responsibility to challenge claims that they think are
not appropriate?
Mr. Gomez. We believe so, but they have not done that.
Mr. Pitts. Why hasn't EPA challenged companies on CBI
claims?
Mr. Gomez. That is a good question, sir. I would have to
get to you if we have the answer but I don't know.
Mr. Pitts. Ms. Bosley, Mr. Rosenberg's testimony suggests
that chemicals under TSCA should be treated like pesticides,
foods and drugs. Do you agree with this view, and why or why
not?
Ms. Bosley. I don't agree with that view. Pesticides are
meant to be bioactive and to kill bugs. Foods and drugs are
also meant to be consumed and thus real chemicals are not meant
to be consumed. I think as part of the risk assessment for EPA,
it would certainly look at the exposure pattern that industrial
chemicals are having and they are able to collect data on that.
They do that every 4 years now. So EPA knows what the exposure
patterns are, and based on that exposure pattern, they can
decide to look at a chemical more closely, something close to
what FDA might do, but only when the exposure pattern makes it
necessary.
Mr. Pitts. My time is expired. Thank you, Mr. Chairman. I
yield back.
Mr. Murphy. The gentleman yields back and now I turn to the
gentlelady from Colorado, Ms. DeGette, for 5 minutes.
Ms. DeGette. Thank you very much, Mr. Chairman, and I think
it is great that we are having this hearing on TSCA. I have
been interested in this bill since I came to Congress in 1997,
and I have probably said this before: TSCA was enacted over 30
years ago and it is the only major environmental law in this
country that has not been reauthorized. I think we can hear
from the panel today there may be differences in nuance but
pretty much everybody agrees, the industry as well as the
environmental community, that TSCA really needs to be updated
to keep pace with modern technology and to augment the EPA's
resources and authority.
Now, in the 111th Congress, two Congresses ago, this
committee had significant hearings on TSCA, and one of the
results of those hearings was legislation that created a
process for the EPA to select and review high-priority
chemicals against a minimum safety standard. We have other laws
that have been effective at reducing risks related to
pesticides, food and drugs but TSCA has not been effective at
prioritizing action on chemicals that pose a high risk. So I
want to ask some questions around these issues.
The first thing I want to ask is, under Section 6 of the
current law, if the EPA suspects exposure to chemicals puts
people at a serious risk, something I have been looking at is,
can the EPA take action in a timely manner, because, of course,
there has only been six Section 6 actions. All of them took 3
to 5 years. And in my opinion, none of us those were timely.
Ms. Roberts, I am wondering what you think about that. Do you
think that currently Section 6 of TSCA, if there is something
that puts people at a serious risk, can that really operate to
help the EPA make a decision in a timely way?
Ms. Roberts. Thank you for the question. There is another
section under TSCA, Section 7, which I didn't review, and I
apologize, but it relates to imminent hazard. So if EPA were to
find a situation where there was exposure and there was clear
hazard, that they could take action under Section 7 and then
proceed with the Section 6 rulemaking.
Ms. DeGette. But that is if there is an imminent risk, but
the next level down I am talking about is something that is a
serious issue. Those are the ones that are taking 3 to 5 years.
Do you think that that is adequate? Because that is a big gap
between Section 7 and Section 6.
Ms. Roberts. I would agree. I just wanted to point out that
there was that option in Section 7, but I would also agree that
a 3- to 5-year rulemaking is something that is absolutely
burdensome. I am not sure that is a deficiency of TSCA,
however.
Ms. DeGette. OK. But if we could remedy it, certainly that
would be preferable, correct?
Ms. Roberts. I would agree.
Ms. DeGette. Let us just go down right down the row.
Mr. Auer. I would agree, it would be very difficult to
regulate within 3 to 5 years, probably a few years longer
because of the complexities of TSCA as well as the problems
that you encounter in implementing a rulemaking proposal,
consider comments, finalize.
Ms. DeGette. Right.
Mr. Gomez. Yes, we have noted in our report that that is a
long time for EPA to do that, and it would take them, just for
the 83 chemicals that they have chosen right now, over 10 years
to go through them.
Ms. DeGette. Right.
Ms. Bosley. We favor a less burdensome rulemaking process
for EPA as well.
Ms. DeGette. Thank you.
Mr. Rosenberg. It definitely takes too long for the Agency
to be able to do almost anything, certainly under Section 6
under TSCA, and the 3- to 5-year rulemaking in probably many
instances is actually optimistic. The asbestos rule took 10
years, I believe, and lately even other authorities under TSCA
EPA has tried to use including their publishing a Chemicals of
Concern list. They haven't even been able to formally propose a
Chemicals of Concern list because that has been sitting at OMB
for 3 years. So the hurdles EPA faces in taking any action go
far even beyond the structure of the statute, which is pretty
much what we are focused on today. There are bigger challenges
even than that.
Ms. DeGette. Thank you. Not but not least.
Ms. Rizzo. Thank you. I would agree with that, and I would
say the problem goes before we even get to having to make a
rulemaking that we are not looking at the proof of safety first
before we balance out the cost-benefit analysis or any other
decision making. We should be looking at the safety of the
chemical proven first with industry providing that information
to the EPA so that we don't have to deal with this rulemaking
lag.
Ms. DeGette. Right. And I wanted to ask you, Ms. Rizzo,
because in your testimony you talk about endocrine-disrupting
compounds as a chemical of increased concern, and of course, it
is not just pesticides that can alter genes. It can also be
compounds as well. I am wondering of TSCA enables the EPA to
test and evaluate the impacts of those compounds.
Ms. Rizzo. Not adequately on human health and the
environment, and I think that that is the real challenge of how
we look at the classes of chemicals and what we do with them
and how much time it takes, so no, we have not adequately
evaluated EDCs for their impact on health.
Ms. DeGette. Thank you. Finally, I want to take for a
minute about the confidential business information. Mr. Murphy,
although he is pretending he is the chairman right now, he is
actually my chairman of the Oversight and Investigations
Subcommittee, I am the ranking member on that, and we both know
that good oversight requires open government and access to
information, not just for the committee but for everybody, and
I am cognizant about protecting confidential business
information. I do it in other legislation that I am sponsoring.
But if a government agency is going to manage an effective
confidential business information claim program, it needs three
processes: substantiation by the company seeking protection,
Agency verification of CBI status, and opportunity for public
challenge. And TSCA's CBI claims process is absent of that
framework.
So Mr. Gomez, I know that GAO has studied this issue
extensively. Can you tell me what happens when there are
overbroad CBI claims in terms of the EPA process and decision
making? Very briefly, because I am almost out of time.
Mr. Gomez. We have noted that EPA's ability to share data
collected under TSCA is limited when you are dealing with
confidential business information. Now, EPA has made some
progress recently, so we just reported in our March 2013
report, which I wanted to clarify from earlier, that EPA has
expanded public access information. So since 2009, EPA has made
617 formerly confidential chemical identities public because
they have gone through a review process where they have looked
at previous CBI claims and came to the conclusion that they
could be released. EPA has also made 783 previously unavailable
health and safety findings available to the public after
reviewing approximately 15,000 such filings.
Ms. DeGette. Thank you. Thank you, Mr. Chairman.
Mr. Shimkus. The gentlelady yields back her time. The chair
now recognizes the gentleman from Pennsylvania, Mr. Murphy, for
5 minutes.
Mr. Murphy. Thank you, Mr. Chairman.
Ms. Roberts, first of all, can you just tell me what other
federal environmental laws contain the regulatory reach of TSCA
that allows regulation of manufacturing, processing, interstate
and foreign commerce, use and disposal of chemicals and
mixtures of chemicals and what are the law governing chemicals?
Is TSCA the only one?
Ms. Roberts. Absolutely not. TSCA--well, the chemical
industry I think is probably one of the most regulated
industries out there. In addition to TSCA, you have the Federal
Insecticide, Fungicide, and Rodenticide Act, FIFRA. You have
got regulations looking at food, drug, and cosmetics. There is
the Clean Air Act, Clean Water Act, RCRA, Hazardous Materials
Transport Act. There are numerous ones that are out there. I
think the uniqueness of TSCA is recognizing that there are
these other regulatory statutes that cover these particular
special use or applications of companies and that TSCA is
really to capture those that remain, the industrial chemicals,
as I think Ms. Bosley appropriately pointed out.
Mr. Murphy. As a sum total of all those, do TSCA and other
bills prevent the EPA from evaluating chemicals of concern in
any way that causes EPA to ignore or stops them from evaluating
health risk?
Ms. Roberts. No, sir, there is nothing in TSCA that would
hinder EPA from going through that. I think what has been noted
in the testimonies of most of us is, the fact that there is not
a specified prioritization process for existing chemicals.
There has been plenty of opportunity and programs where the
Agency has started up such programs but for whatever reason
they did not sustain momentum.
Mr. Murphy. Mr. Auer, is pollution prevention or other
steps that would have reduced emissions a component of judging
this unreasonable risk?
Mr. Auer. There is a Pollution Prevention Act, and as I
interpret the meaning of ``unreasonable risk'' under TSCA, I
interpret ``pollution prevention'' for substitutes, et cetera,
et cetera all to be important components which go into that
meaning of ``unreasonable risk,'' so, yes, pollution prevention
is encompassed.
Mr. Murphy. OK. Someone told me that water may not meet the
standards of passing TSCA. Is that true?
Mr. Auer. I think it is listed on the inventory. I don't
know that we have assessed it.
Mr. Murphy. I know in certain amounts if inhaled it can be
lethal.
Mr. Auer. Well, it can. There is water intoxication.
Mr. Murphy. And I am not making light of that, but I do
want to find out health effects, and I want us to focus on
science, and that is critically important.
Ms. Bosley, welcome here from western Pennsylvania. You
mentioned that the cost and practicality of blanket testing
requirements for chemicals would discourage new chemicals from
coming to market. So generally speaking, how much would a well-
characterized study on a new chemical cost your company?
Ms. Bosley. So if we were to do what is called a base set
of testing as maybe is required in Europe, a single chemical
could cost between a half a million and three-quarters of a
million dollars, which is more than the profit my company makes
in 5 years' time. So we certainly wouldn't--especially on a new
chemical when we don't know the markets, so when we submit a
PMN, we back up 90 days from when we think there will be
commercial manufacture and usually more than that because we
want to give ourselves time. We haven't fully assessed the
market yet or the economics yet or even the final product form
so we would never undertake that testing if it were to cost
that much under such an unknown market analysis.
Mr. Murphy. If you had to receive regulatory approval prior
to developing and selling any of your products, similar to the
REACH program that they have in the European Union, what would
happen to your customers and your business?
Ms. Bosley. They would be gone. They would go overseas
where you don't need those sorts of protections before you
enter into a market. I can say that because there is not
testing when we first put in a PMN, it doesn't mean that we
have stopped testing. EPA has another provision within TSCA
called TSCA AD where when we do have new test data, we are
required to submit it to EPA but only if it is adverse. So if
we have predicted a certain toxicity and our chemical actually
comes back less toxic than that, we have no provision to give
that information to EPA.
Mr. Murphy. So the EPA does not get that information?
Ms. Bosley. They do not.
Mr. Murphy. Do you take any steps at your location to deal
with reducing any potential human hazards?
Ms. Bosley. Oh, of course. We assess all the hazards that
we can when we are first making a chemical. EPA does allow us
to go into the lab and start making a chemical under an R&D
exemption before we file that PMN. So we are able to assess a
broad range of hazards before we are interested in entering to
market, and every step we take, there is a risk assessment done
within my own company, and we reduce the risk of that chemical
exposure to humans and to the wastes that we generate. That is
all part of our new chemical process.
Mr. Murphy. Beyond that of what the EPA requires?
Ms. Bosley. Oh, much beyond what EPA requires, yes.
Mr. Murphy. Why?
Ms. Bosley. It is good business sense. We are a small
chemical company. We have limited resources. We don't want to
spend our money getting rid of waste. We want to spend our
money on new product development and innovation.
Mr. Murphy. And taking care of your employees?
Ms. Bosley. That is right.
Mr. Murphy. Thank you. I yield back.
Mr. Shimkus. The gentleman yields back his time. The chair
now recognizes the gentlelady from California, Ms. Capps, for 5
minutes.
Mrs. Capps. Thank you, Mr. Chairman.
It is so easy to focus on all the details of this statute
and miss the big picture of why we are here, in my opinion. I
would like to focus on one of the most important reasons for
this law. Increasingly, researchers tell us that environmental
exposures are a key factor in the onset of cancer. That means
we need an effective Toxic Substance Control Act reform to
fight cancer. According to the President's Cancer Panel in May
of 2010, 41 percent of Americans will be diagnosed with cancer
at some point in their lives, and about 21 percent will die
from cancer. The panel also found that the true burden of
environmentally induced cancer has been grossly underestimated
and that the American people do not have sufficient information
about harmful chemical exposures or how to prevent them.
In February of this year, the interagency Breast Cancer and
Environmental Research Coordinating Committee released a new
report called ``Breast Cancer and the Environment: Prioritizing
Prevention.'' We are fortunate to have with us here today a
member of that committee who was involved in crafting that
work. Ms. Rizzo, based on your work on that report, can you
briefly describe the emotional, physical and financial burden
of breast cancer? And that is a huge question to ask you in a
very short time.
Ms. Rizzo. Thank you. We talked about the fact that 3
million women in this country are living having been diagnosed
with breast cancer and 40,000 families will deal with death.
Friends, families, when you think about the total number of
people impacted by this disease in this country, it is
overwhelming. The report did an analysis of the amount of money
spent on the diagnosis and treatment of breast cancer, and that
is about $17.5 billion a year. That doesn't relate all the
additional costs--the human cost, the cost of childcare, the
cost of getting to your treatments, the loss of work. So it is
a tremendous burden on the country and a burden on the economy,
a burden on the contribution of women to our world, to our
social justice as mothers. We have lost mothers, lost school
teachers. So the burden is quite dramatic, and the report
addressed that pretty significantly. Thank you for asking.
Mrs. Capps. What can we do as policymakers to lessen that
that burden or to prevent this terrible disease altogether?
Ms. Rizzo. What actions do we need to take?
Mrs. Capps. What can we do as policymakers?
Ms. Rizzo. As policymakers, to look at the exposures to
chemicals that have evidence of harm and to navigate the
science, weigh the evidence. If you are making a decision for
or against an exposure, as for proof of safety rather than
unreasonable risk of harm. I think we have the wrong paradigm,
and it is demonstrated in the fact that there are so many
people with chronic illnesses and that we are finding these
toxic chemicals in our bodies.
Mrs. Capps. So is there a role, and would you describe what
it might be, the TSCA reform can play in preventing breast
cancer?
Ms. Rizzo. Absolutely. I think one of the key issues in
TSCA reform is to look at the science. The National Academies
of Science gave a report on how to look at doing the science,
giving authority to the EPA to look at the science that isn't
just good laboratory practices but to look at the academic
science that could inform their decision making. So I think the
safety standards have to be met on that. I think we also have
to look at the way TSCA can look at the regulatory process,
speeding it up, look at vulnerable populations. I think all of
those contribute to the prevention of disease.
Ms. Capps. For so many women, men, families, communities,
the fight against breast cancer is a matter of life and death.
We have it in our power to limit some of the environmental
exposures that can cause this disease. I thank the chair for
calling this hearing, and I hope it is the start of a serious
effort to address the problems in TSCA and to better protect
the American public. Thank you very much, and I will yield back
the balance of my time.
Mr. Harper [presiding]. The gentlelady yields back and I
now recognize Mr. Johnson from Ohio for 5 minutes.
Mr. Johnson. Thank you, Mr. Chairman, and I want to thank
our panel members for being with us today.
Mr. Auer, your testimony mentions that new chemical
regulations can apply to more than one company. How frequent is
this practice?
Mr. Auer. Thank you for the question. It is quite frequent.
There can be a toll manufacturer. There can be downstream
companies that buy that chemical. When EPA negotiates a 5(a)
order, a requirement can be to extend those requirements
downstream. EPA also has Significant New Use Rule authority,
which can apply those requirements to any other company that
makes or processes that chemical.
Mr. Johnson. OK. Some people have critically testified
before this committee in the past about the regulatory and
management outcomes under TSCA. Have the regulatory and
management outcomes been as limited as some suggest?
Mr. Auer. As I overelaborated in my statement as well as in
my testimony, there are a lot of facts there. I am not arguing
that enough has been done, but I think there has been a
mischaracterization of the extent of the work. The fact that
300 or more existing chemicals are regulated under SNURs, many
of those are any-use SNURs. They are basically out of the
market, as well as the other requirements. They are
consequential and they need to be given due account.
Mr. Johnson. OK. Does TSCA promote innovation, in your
view?
Mr. Auer. You know, I think the way TSCA struck the balance
with new chemicals in taking the tough decision not to require
testing and the costs associated with that has resulted in the
United States leading the world in the innovation of new
chemicals which, as I indicated before, I believe to be safer
and greener. That is key.
Mr. Johnson. All right. Ms. Bosley, you mentioned that the
Existing Chemical Program faces challenges. How could EPA have
such a performance disparity between new and existing chemical
programs?
Ms. Bosley. I think that all lies in the mandate from
Congress. Frankly, the mandate and the time frames are very
well laid out in TSCA for new chemicals but not so in existing
chemicals. EPA has broad authority for existing chemicals to
prioritize, to ban, to limit uses, but I think very few
resources since there is no mandate.
Mr. Johnson. Well, what are your views on a strategy that
relies on tailored restrictions rather than outright bans?
Ms. Bosley. Oh, I think restrictions are generally a better
idea. So even in the asbestos case, let us just say, there are
zero exposure but very critical uses of asbestos today in
aerospace, space shuttle operations, some firefighting
operations that a ban of asbestos would have eliminated and
there was no clear alternative. So if you can demonstrate that
there is a no-exposure use for even a very hazardous chemical,
that use should be allowed to go on, so restrictions are much
better than bans.
Mr. Johnson. Well, thank you, Mr. Chairman. I yield back
the remainder of my time.
Mr. Shimkus. The gentleman yields back his time. The chair
now recognizes the gentleman from California, Mr. McNerney, for
5 minutes.
Mr. McNerney. Thank you, Mr. Chairman. I thank the panel
for testifying today.
Mr. Rosenberg, I understand there are some 84,000
synthesized chemicals used in the United States today. Is that
about right?
Mr. Rosenberg. There are roughly 84,000 chemicals on the
TSCA inventory. They are not all in use at any one particular
time, and the estimates are maybe that there is quite a bit
fewer that are actually in use right now. We don't have as
great a picture on that as we would under a better functioning
TSCA. But any of those chemicals that are on the inventory can
be used, manufactured or used at any given time. So if they are
not in use now, they could be at some time in the future
without additional review currently.
Mr. McNerney. How many of those have been cleared for use
of those 84,000?
Mr. Rosenberg. Well, the 62,000 roughly were grandfathered
in, so those made it, and I believe the bulk by volume of
chemicals that are in use now are from that original 62,000.
The 22,000 were reviewed. I think there is some discussion
about the extent that they were reviewed but the 22,000
chemicals have some amount of review.
Mr. McNerney. So in your opinion, there are many chemicals
that are being used even according to manufacturer's
specifications finding their way into the environment and to
human bodies?
Mr. Rosenberg. Yes, absolutely that is the case, and the
one piece of evidence for that is the CDC has done its biannual
biomonitoring of people and has found--the more they look for,
the more they find, but they have found hundreds of chemicals
widely in people's bodies and their blood. So there is no
question that even chemicals used as intended, whatever that
might mean, are still winding up in people's blood or in their
bodies and their tissues in ways that I assume weren't intended
and are not good for people's health, presumably.
Mr. McNerney. Ms. Rizzo, have you heard of the term
``chemical trespass''?
Ms. Rizzo. Yes, sir, I have.
Mr. McNerney. Would you explain what that means, please?
Ms. Rizzo. That is basically, I haven't given you
permission to put that chemical in my body. It is trespassing
into my body. That is how it is used. So I think when Mr.
Rosenberg referred to biomonitoring, when you measure in blood,
urine, cord milk, other body specimens, the presence of
chemicals that you did not intend to have in your body that
way, you didn't ask for it, you didn't give permission, that is
what the trespass it.
Mr. McNerney. Thank you. Mr. Rosenberg, do you share the
view that the statutory changes are needed to protect human
health and the environment from unsafe chemicals, or is the EPA
going to be able to do this without statutory changes?
Mr. Rosenberg. No, they won't be able to do it without
statutory changes, and it is interesting, if you go back and
look, GAO has been saying essentially that for 20 or 30 years.
They wrote their first report on TSCA in 1980. They identified
very much the same problems then that they are identifying now
and it is really up to Congress to step up and take this effort
seriously, and at this point the law is such a failure that,
you know, a broader range of stakeholders is recognizing that
it is causing problems--I talked about this a little bit in my
testimony--as a result of this vacuum that is left by EPA's
inability to take action, even when they have tried to. States
are adopting all kinds of different use restrictions and other
bans and activities, and the marketplace is also taking action.
I don't think any of that is a bad thing but it is a sign that
TSCA is really not working. I mean, there is some preemption
authority under TSCA but it has never been exercised as far as
I know because they have never been able to accomplish anything
that would even hint at preemption. So it is a nonfunctioning
law to a great extent, not a total extent but a large extent.
Mr. McNerney. Well, is bureaucratic delay in clearing
chemicals part of the problem in protecting our safety? Does
anyone want to answer that on the panel?
Mr. Auer. The New Chemicals Program takes 90 percent of its
decisions within 90 days. The remaining chemicals, there can
sometimes be a bit of delay but, you know, within months or
sometimes longer everything is decided.
Mr. Rosenberg. It would be absolutely critical for Congress
to seriously look at streamlining EPA's ability to do different
things including getting data from companies and taking
actions, both regulatory action and assessment actions, and
there is, in addition to whatever hurdles EPA faces, one hurdle
is that they are underresourced significantly and particularly
in this program, so that is a problem, and then I mentioned
this earlier, OMB has been sort of roadblock for even things
that EPA has tried to do, particularly in the last few years,
with their existing authority. They have taken a number of
steps to try to get more information out to the public and
assess chemicals, and every step of the way they have been
bogged down by OMB, and that a whole other major problem.
Mr. McNerney. Thank you, panel members, and thank you, Mr.
Chairman.
Mr. Shimkus. The gentleman's time is expired. The chair now
recognizes the gentleman from Mississippi, Mr. Harper, for 5
minutes.
Mr. Harper. Thank you, Mr. Chairman, and thank each of you
for being here and giving us your insight. We have many things
we need to look at as we go back and review this and see where
we are, and I would like to start with Ms. Roberts, if I could.
Thank you for your earlier presentation. I tried to squint
as best I could to read the slide and follow that, but thank
you for your time on that. Can you tell me what the practical
difference is between the authority in Sections 4 and 8 to
develop information?
Ms. Roberts. Sure. My apologies for the small print on the
slides, but I did want to try to fit everything into one slide
so that people could sort of reference it back. So under
Section 4, EPA has the authority to require testing, and I am
trying to find the exact wording, but if there is concern of an
unreasonable risk for a chemical, that is one finding that EPA
can make to issue a test rule, or if the chemical is produced
or released into the environment in substantial quantities,
that is the second finding that EPA would have to make in order
to issue a test rule. It seems to me that the Section 8
provisions that currently exist give EPA that opportunity to
collect that information. Section 8(e) requires companies to
immediately inform EPA if there is a substantial risk on a
chemical. Section 8(c) requires companies to provide EPA upon
request information that they gather from their companies. So I
think that would make that first finding the significant risk.
The second finding of production volumes are already collected
under the chemical data reporting, which occurs every 4 years,
or under Section 8(a) should EPA decide they want to gather
that information.
Mr. Harper. OK. Can EPA gather enough information under
Section 8 to justify a test rule under Section 4?
Ms. Roberts. It is my belief that they could, yes, sir.
Mr. Harper. Now, I know Mr. Rosenberg had argued that CBI
should be protected less and re-substantiation required for
these claims. What are the issues that come with it?
Ms. Roberts. I think we need to recognize that TSCA covers
a huge gamut of different industries and different businesses,
and so while the idea of re-substantiation on a certain
periodic time may make sense for some companies, it may not for
all. So for certain companies, for example, Coca-Cola comes to
mind. They are not going to share their formulation ever. So if
they had to re-substantiate that every year, and I realize it
is not covered under TSCA but it is the first example that came
to mind, that would be very problematic for them. And again,
keep in mind the type of information that is required under
TSCA under New Chemical Notification. You have to tell the EPA
what the byproducts are, what the impurities are. That could be
very meaningful information for a competitor because now they
know what you are using to manufacture that. Volumes produced,
again, could be very meaningful to a competitor to get a better
understanding of what your market share is so that they may be
able to glean into it. So again, CBI is extraordinarily
important and really should not be taken lightly.
Mr. Harper. Thank you for that.
Ms. Roberts. My pleasure.
Mr. Harper. Mr. Gomez, if I may ask you, the Acting
Administrator of EPA's Chemical Office told you that the law
makes it impossible for EPA to assess and regulate chemicals.
How will EPA use its requested $67 million for this office in
fiscal year 2013?
Mr. Gomez. That is a very big question, and a good
question, and that is something that we will have to get back
to you on since EPA is not here, who could probably better
answer it. But EPA, one thing that I do want to mention though,
EPA has this new approach that I talked about in my statement,
and so in this new approach, they are doing new things using
the existing TSCA authority. So one of the things that we
talked about earlier already is they are extending those
Significant New Rule uses where they have added a lot more
chemicals that they are looking at, so they are trying
different things to try and get more information. We noted that
basically it is too early to tell whether that is going to be
achievable or not, especially since in their strategy they
haven't laid out some key elements that we think are needed for
them to succeed.
Mr. Harper. Do you agree with that assessment, that the
resources are not there, that $67 million is not sufficient to
do this?
Mr. Gomez. Sure. That is what the Agency has told us also
that it is a reason because of resources but it is not
something that we have looked at specifically to see if they
have the resources.
Mr. Harper. And you will have to give me a quick answer on
this, but your testimony mentions the EPA creation of a
Chemicals of Concern list under Section 5(b)(4) and the delay
of this list at OMB. Could you please explain in very short
order for me the specific understanding of and maybe the
criteria for the ``may present'' clause which either gets a
chemical on or off the list?
Mr. Gomez. Well, very briefly, that is something I will
have to get back to you on, but that list is still at OMB. It
has been there for a while. So----
Mr. Harper. I would appreciate it if you could give me a
detailed answer to that.
Mr. Gomez. We will do that.
Mr. Harper. Thank you very much. I yield back my time.
Mr. Shimkus. The gentleman yields back. The chair now
recognizes the gentleman from Texas, Mr. Green, for 5 minutes.
Mr. Green. Thank you, Mr. Chairman. I appreciate your
holding this timely hearing on the Toxic Substance Control Act.
Over the years--and again, some of you may not know I represent
a district that is heavy petrochemical, the biggest
petrochemical complex in the country, second in the world.
There is nearly universal consensus among all stakeholders that
we need to have TSCA reform, and it is necessary to provide
greater regulatory certainty for the industry while giving EPA
the necessary authority to protect human health and the
environment from hazardous chemicals, and I know the Senate
just before the death of Senator Lautenberg, he and Senator
Vitter had introduced legislation that had been put together as
a compromise. We have had TSCA reform legislation in the House
and Senate for it seems like my whole career here, and it has
never gotten anywhere. So maybe we need to see what we can do
to bring the parties together which the Senate has been doing
and work across the aisle.
My first question is for the whole panel. In 2008, I
introduced a bill that would have banned the import,
manufacture and distribution of asbestos in response to a 1991
court hearing that the EPA's attempted ban of the substance did
not follow the least burdensome requirement clause under TSCA.
My question for everybody on the panel: If the least burdensome
requirement were removed from TSCA, would EPA have a strong
authority to protect human health and environment and be able
to uphold future bans on known dangerous substances like
asbestos before a court trial? If you could do yes or no,
obviously we have a big panel. In fact, we have more panel than
we do members.
Ms. Roberts. Although I am not a lawyer, I think I am going
to say it depends. I think I would be concerned if there was
not a least burdensome aspect in the regulation simply because
banning an entire chemical versus picking certain applications
that are high risk could be problematic, and so I think there
is some good reason for least burdensome, and I leave that as
my answer.
Mr. Auer. I think the ``the'' in ``the least burdensome''
is a big part of the problem. I do think that those concepts
are important and need to be accommodated in any such
determination.
Mr. Green. Mr. Gomez?
Mr. Gomez. Sure. That is something that really is a policy
call, I believe. I mean, GAO has gone on record to say that it
is a high legal threshold for EPA to meet and has had
difficulty meeting that, and if that is changed, whether or not
that results in different outcomes.
Mr. Green. Anyone else on the panel?
Ms. Bosley. I agree with Charlie that ``the least
burdensome'' is probably too high a threshold but ``least
burdensome'' should be in the mix there as far as the risk-
making decision.
Mr. Rosenberg. ``Least burdensome'' is definitely a
problem, and EPA would be better able to regulate without it.
TSCA contains a bunch of options that EPA has to use, and there
is no reason that they should or would always go to the maximum
option that they have but in certain instances that is the most
health protective, and since the statute is intended to be
health protective, that should have priority.
Ms. Rizzo. Yes, I would just add that the burdensome part
is also the burden on public health that should be weighed
evenly with the burden on business in making that decision.
Mr. Green. OK. Ms. Roberts, in your testimony you state
that the EPA has been constrained when using its rulemaking
authorities. Why is that, and what are the ramifications of
that constraint?
Ms. Roberts. In my view, the reason that they are
constrained is because rulemakings in general take a long time.
There is a lot of administrative procedures that are required
under rulemakings so that, I believe, is the problem. The
ramifications are that they can't gather information in a
timely manner and therefore can't make decisions as far as risk
management or the needs for testing.
Mr. Green. Also in your testimony, you note that EPA could
implement a prioritization process which specifies timelines
for Existing Chemical Review. Could you elaborate on the
benefits of a prioritization process and how it would improve
TSCA?
Ms. Roberts. Sure. Again, because under the New Chemical
Review there is a certain statutory deadline that is associated
with that, if there were a specific deadline or at least for a
prioritization of existing chemicals that EPA will go through
during a review, I think that would keep EPA sort of on the
straight and narrow. They would get some work accomplished. As
I had said before, there are programs that have started and
stopped. I think what we need is to maintain momentum under one
particular prioritization program.
Mr. Green. Mr. Chairman, in my last 14 seconds, I guess,
Mr. Gomez, and you might have to get back with me on this. In
your testimony, you note that EPA has difficulty in obtaining
adequate information on chemical toxicity and exposure. Has GAO
provided recommendations to EPA on how to improve information
gathering so that the status of EPA's actions on these
recommendations, and also in your professional opinion, does
EPA have sufficient resources--staff, funds--to effectively run
TSCA?
Mr. Gomez. Certainly. We have noted and have commented on
the first part of your question and talked about the SNURs that
we mentioned earlier, that that is the way that EPA is getting
additional information now. The second part of the question we
will have to get back to you on.
Mr. Green. Thank you. Thank you, Mr. Chairman.
Mr. Shimkus. The gentleman's time is expired. The chair now
recognizes the gentleman from Louisiana, Mr. Cassidy, for 5
minutes.
Mr. Cassidy. Thank you all.
Mr. Rosenberg, just a couple things. You listed the
statistics for cancer, how prevalent it is in our society, but
you did not mean to suggest those are all due to chemical
exposure, I presume?
Mr. Rosenberg. That is correct.
Mr. Cassidy. I will just say, your testimony kind of gave
way to that. Secondly, let me ask you, you are not also
suggesting that when you say that even minimal exposure can
cause cancer that there isn't a threshold effect? Anyone who
has ever had a hangover has had formaldehyde in their body, and
yet--formaldehyde as a metabolite of alcohol--but yet it is not
known to cause cancer in that low level or probably half the
room wouldn't be here. And so again, you are not suggesting
there is not a threshold effect, which is a fairly well
documented scientific concept.
Mr. Rosenberg. Yes. The most recent National Academy of
Sciences studies actually recommend EPA's methodology for
assessing chemicals not to assume a threshold. They
traditionally have not assumed a threshold but----
Mr. Cassidy. They haven't, but the Native American of
Sciences criticized the EPA for not doing so in their
methodology on their formaldehyde sort of regulation. As a
doctor, I will acknowledge that aflatoxin is something we are
all exposed to. It is well known as a carcinogen for liver
cancer but it is only over a certain threshold that risk poses
itself, not the amount that we get opening up a little bit of
an old jar of peanut butter. If you will send that to me, I
would like to see where they deny that there is not that
threshold effect.
Mr. Rosenberg. Absolutely. I would be happy to send that to
you.
Mr. Cassidy. Ms. Rizzo, it turns out my wife is a breast
cancer surgeon, and so we were on vacation recently, and you
may think we don't have a life, but we were actually looking up
the literature on chemical exposure and breast cancer, so it
just so happens and serendipitously----
Ms. Rizzo. On your vacation, sir?
Mr. Cassidy. What is that?
Ms. Rizzo. Was that on your vacation?
Mr. Cassidy. It was on our vacation, believe it or not.
Again, get a life, huh?
Now, I was struck, though, when I looked at the literature
that really if you look at the top nine things that are
associated with breast cancer, chemicals are not on that top
nine or top eight or top seven, and when they speak--unless you
include estrogen or hormonal therapy, and then they attribute
that overwhelmingly to the metabolic syndrome with high rates
of obesity and low rates of physical activity. While we were
speaking, I loaded the document that you have in reference 3,
the recent IB whatever, and they again emphasize the role of
obesity and the metabolic syndrome, absence of physical
activity, but don't give the prominence to chemicals except
insofar that rat mammary tissue is affected but they admit that
it is unclear how well that would translate to human studies.
Any comments on that? Because from your data, from your
presentation, I get a sense that chemicals are the etiology,
and my wife has just told me you have to reassure women as to
what--rightly reassure them as to what the real risk is because
they can modify cigarettes and alcohol and weight and physical
activity. If you add the existential concern of chemicals,
which is very unproven as to their role, then that makes it
harder for the physician to provide that reassurance. What are
your thoughts on that?
Ms. Rizzo. Well, we are sympathetic with the uncertainty
and with the difficulty that it provides. If you look at all of
the known risk factors, you can account for maybe half of
breast cancer. I will give you an example that might be working
looking at----
Mr. Cassidy. Well, no, not if you include estrogen because
obviously women--my wife always says, and believe me, if I
could channel my wife here, I would be a much better man. My
wife would say that the primary risk factor for breast cancer
is being a woman, and she would then say that it clearly is
related to hormones because it happens after menarche, and that
the earlier the menarche, i.e., the longer the exposure to
estrogen, the higher the risk, and then you go into cigarette
smoking and alcohol. Now, we do know the risk factor, and it is
estrogen exposure.
Ms. Rizzo. Well, it is also estrogen-mimicking exposure,
and that is where the toxic chemicals come in.
Mr. Cassidy. Now, that literature, though, is very thin. I
have looked at it, and it is principally among rat mammary
tissue, and it is unclear from the scientists, and that article
that you referenced points this out, that it is unclear how
well you can translate rate data to human data. Do you dispute
that?
Ms. Rizzo. I don't think that was the conclusion of the
report. The animal-to-human paradigm was an essential factor in
this issue. The hormonal factor, the chemical exposure factor--
I will give you another example.
Mr. Cassidy. Those are two different issues, though. The
hormonal factor again is related to physical activity and
obesity. The more physical activity, the less obesity, and the
more obesity, the earlier the age of menarche, that is so well
established, and my wife is always preaching that gospel, so
that is why I want to make sure that we acknowledge what we
know to be the strongest risk factors and also acknowledge that
the role of chemicals is really not as well defined.
Ms. Rizzo. Which part of that would you like me to
challenge back?
Mr. Cassidy. The very last one, because all the studies I
have read were all on rat data, so unless the rat data is----
Ms. Rizzo. No, there is also human data. We are in the
middle of a human experiment, and I will give you a couple
examples of that. Camp Lejeune, the military base, where these
military men were exposed to solvents in the water. We have
over 100 cases now of male breast cancer as a result of that
exposure to that toxic chemical. Male breast cancer is not an
ordinary occurrence. You wouldn't expect a cluster of it. Very
highly associated to a chemical exposure. So that is one factor
that I wanted to point out.
Mr. Cassidy. I have read about this 3 years ago so I am a
little rusty but the Army takes some issue with that
epidemiology, as I recall. I am not saying you are wrong. I am
just saying that before we accept it as totally unchallenged, I
think I remember that the Army does challenge that. Is that
fair? Oh, I am sorry, the Marines. I don't want to offend
anybody.
Ms. Rizzo. No, it was Marines. The ATSDR is looking into
that at the CDC, and I am more than happy to follow up with
some additional information on that. And the second part has to
do with the BRCA gene and----
Mr. Cassidy. That is purely genetic.
Ms. Rizzo. Yes, that is genetic, but there is a four- or
five-fold increased risk of breast cancer in women with the
BRCA gene than there was back in the 1940s.
Mr. Cassidy. But then also if you look at the mean body
weight of women from now relative to the 1940s, the mean body
weight is significantly higher than it formerly was, again
supporting the fact that obesity and the estrogens produced by
adipose tissue, or fat tissue, is a stronger risk factor as
your paper promotes.
Ms. Rizzo. I would also look at obesogens, sir, and I am
happy to send you some on the chemicals that act as obesogens
that are contributing to early childhood obesity and early
puberty.
Mr. Shimkus. The gentleman's time is far expired. I have
enjoyed the questioning. Now the chair recognizes the ranking
member of the full committee, Mr. Waxman, for 5 minutes.
Mr. Waxman. Thank you, Mr. Chairman. I want to continue to
pursue that issue because there are a lot of different causes
for disease and we can isolate some but we can't know all the
factors that are happening.
Every day American people come in contact with a wide range
of chemicals in their food packaging, in their furniture, in
their workplace. They believe these chemicals have been found
to be safe, that they have been tested, but this is a mistaken
impression. In many cases, chemicals simply aren't tested, and
in some cases, even chemicals that we know pose substantial
risk remain in the products that we use every day. As cancer
rates and the rates of other serious health issues arise, we
have an obligation to do more.
So Ms. Rizzo, what are some of the carcinogenic chemicals
that have been linked to breast cancer or to mammary tumors in
animal studies?
Ms. Rizzo. Well, I think you can look at some of the--you
know, we have benzene, we have the solvents, we have some of
those chemicals, organochlorines, the persistent
bioaccumulative chemicals. Then we have those chemicals that
disrupt the endocrine system that we were speaking about
earlier that are provocative, that act like estrogen, that
trick your body into believing you have been exposed to
estrogen, which we know a woman's lifetime exposure to estrogen
increases her risk. So if your body is exposed to chemicals
that act like estrogen, they provoke in the same way. We saw
that with hormone replacement therapy. I don't think anybody
can forget years ago when the Women's Health Initiative study
came out, and millions of women stopped taking hormone
replacement therapy, which was increasing risk between 26 and
40 percent, and we saw a drop in breast cancer incidence at
that point because women exposed to that hormone for 4 years or
more had a dramatic increased risk. So we know that hormonally
active chemicals, biologically active chemicals are connected
to breast cancer.
Mr. Waxman. Are those the same as carcinogens?
Ms. Rizzo. They are not categorized as carcinogens. They
provoke in a different way. They can set is up for other
exposures that provoke rapid cell C invoice or interfere with
periods of time when our cells are in rapid cell development.
Mr. Waxman. Have adequate restrictions been imposed on
these chemicals that you are discussing to prevent human
exposure to the extent possible?
Ms. Rizzo. I would say no, they are not.
Mr. Waxman. What are some of the ongoing uses of those
chemicals that might lead to dangerous exposures?
Ms. Rizzo. Those chemicals, I will give you--there are
chemicals in our food can linings. There are chemicals in
personal care products. They are not all under the control and
auspices of the Environmental Protection Agency. But that which
EPA and TSCA does to assess risk, to look at chemicals has an
influence across the broad spectrum of uses. So if we don't
test chemicals that we are exposed to in a real way every day
in real time, in mixtures, in accumulation and over time, then
we will never fully understand, as was raised, what their
contribution is but we know that if in cell studies they are
making cells turn into cancer, if they are giving mammary
tumors in animals, then we should expect a similar impact on
humans. We do that to test pharmaceuticals. We like animal
testing when we are trying to approve a pharmaceutical for
clinical trial. We don't like it so much when it tells us the
chemical may harm us.
Mr. Waxman. My colleague was talking about other factors--
obesity, cigarette smoking. I would assume that gene that would
make a woman more susceptible or more likely to have breast
cancer would be another factor. If those factors are serious
factors, does that negate the impact of these chemicals?
Ms. Rizzo. Not at all, and 5 to 10 percent of breast cancer
is associated with the breast cancer gene. Smoking is a
chemical, so let us not forget, tobacco smoke and secondhand
smoke are chemicals. When you look at the obesity and you look
at the contributing factors to obesity and you look at some of
the chemicals in food packaging and in food, then we have to
ask the question, what are the other exposures that are
contributing to that. It is not simply a matter of eating too
much.
Mr. Waxman. Let me ask you about these endocrine disruptors
because you seemed to single them out as the most serious. Have
those chemicals been adequately restricted or banned, and what
are some of their ongoing uses to which we might be exposed?
Ms. Rizzo. Endocrine disruptors have not been, and I think
there is an effort--the endocrine disruption panel that should
be working on this is, I don't know, 10 years behind time, I
think. We can certainly get more information for the committee.
I don't want to mistake that time frame. But that is not an
insignificant effort that needs to be made to look at the
impact of endocrine-disrupting chemicals, and we are not
talking just about breast cancer. We are talking about
testicular cancer, prostate cancer. These are hormonally
responsive cancers, and it is demonstrated in cell and animal
studies. So I think it is very important that we look at those,
that we study them adequately and that where we don't need
them, we shouldn't be using them when they are non-essential.
There are things that we essentially need but we don't need to
have some of those chemical exposures, and I think it will spur
innovation if we say we are concerned about them, come up with
an alternative to bisphenol-A or to phthalates or to some of
the others. And I am sure our American industry can do it. We
are smart. I am confident in them.
Mr. Waxman. Thank you, Mr. Chairman.
Mr. Shimkus. The chair thanks the ranking member. The chair
wishes to thank you all for a really productive and educational
hearing. I want to advise you that you will be receiving
written questions as were posed, and your answers will be
included for the record. I want to advise members that there
will be five legislative days for members to submit opening
statements for the record. Finally, with all the interest in
this subject, we are going to leave the record open to receive
helpful comments on this subject. Without objection, so
ordered.
The hearing is now adjourned.
[Whereupon, at 12:14 p.m., the subcommittee was adjourned.]
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