[Senate Hearing 109-1078]
[From the U.S. Government Publishing Office]
S. Hrg. 109-1078
TOXIC SUBSTANCES CONTROL ACT AND THE CHEMICALS MANAGEMENT PROGRAM AT
EPA
=======================================================================
HEARING
BEFORE THE
COMMITTEE ON
ENVIRONMENT AND PUBLIC WORKS
UNITED STATES SENATE
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
__________
August 2, 2006
__________
Printed for the use of the Committee on Environment and Public Works
Available via the World Wide Web: http://access.gpo.gov/Congress.senate
__________
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COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS
ONE HUNDRED NINTH CONGRESS
SECOND SESSION
JAMES M. INHOFE, Oklahoma, Chairman
JOHN W. WARNER, Virginia JAMES M. JEFFORDS, Vermont
CHRISTOPHER S. BOND, Missouri MAX BAUCUS, Montana
GEORGE V. VOINOVICH, Ohio JOSEPH I. LIEBERMAN, Connecticut
LINCOLN CHAFEE, Rhode Island BARBARA BOXER, California
LISA MURKOWSKI, Alaska THOMAS R. CARPER, Delaware
JOHN THUNE, South Dakota HILLARY RODHAM CLINTON, New York
JIM DeMINT, South Carolina FRANK R. LAUTENBERG, New Jersey
JOHNNY ISAKSON, Georgia BARACK OBAMA, Illinois
DAVID VITTER, Louisiana
Andrew Wheeler, Majority Staff Director
Ken Connolly, Minority Staff Director
(ii)
C O N T E N T S
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Page
AUGUST 2, 2006
OPENING STATEMENTS
Boxer, Hon. Barbara U.S. Senator from the State of California.... 29
Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma... 1
Jeffords, Hon. James M., U.S. Senator from the State of Vermont,
prepared statement............................................. 30
Lautenberg, Hon. Frank R., U.S. Senator from the State of New
Jersey, prepared statement..................................... 9
WITNESSES
Charnley, Gail, Ph.D., President, Healthrisk Strategies.......... 19
Prepared statement........................................... 86
Responses to additional questions from:
Senator Boxer............................................ 96
Senator Inhofe........................................... 94
Senator Jeffords......................................... 95
Goldman, Lynn R., M.d., M.p.h., Professor, Environmental Health
Sciences, Johns Hopkins University, Bloomberg School of Public
Health......................................................... 14
Prepared statement........................................... 73
Responses to additional questions from:
Senator Inhofe........................................... 77
Senator Jeffords......................................... 79
Gulliford, James B., Assistant Administrator, Office of
Prevention, Pesticides and Toxic Substances, U.S. Environmental
Protection Agency.............................................. 2
Prepared statement........................................... 31
Responses to additional questions from:
Senator Boxer............................................ 35
Senator Clinton.......................................... 40
Senator Inhofe........................................... 34
Senator Jeffords......................................... 35
Rawson, William K., Partner and Chair of the Environment, Land
and Resources Department, Latham and Watkins................... 12
Prepared statement........................................... 61
Responses to additional questions from:
Senator Inhofe........................................... 70
Senator Jeffords......................................... 73
Stephenson, John B., Director, Natural Resources and Environment,
U.S. Government Accountability Office.......................... 4
Responses to additional questions from:
Prepared statement........................................... 41
Senator Boxer............................................ 50
Senator Inhofe........................................... 48
Walls, Michael P., Managing Director of Regulatory and Technical
Affairs, American Chemistry Council............................ 16
Prepared statement........................................... 52
Responses to additional questions from:
Senator Boxer............................................ 59
Senator Inhofe........................................... 56
Senator Jeffords......................................... 58
Wilson, Michael P., Ph.D., M.p.h., University of California,
Berkeley....................................................... 17
Prepared statement........................................... 81
Responses to additional questions from:
Senator Inhofe........................................... 83
Senator Jeffords......................................... 85
ADDITIONAL MATERIAL
Reports:
California Policy Research Center, University of
California; Green Chemistry in California: A Framework
for Leadership in Chemicals Policy and Innovation...... 142
William K. Rawson, Latham & Watkins LLP; Defense of the
Toxic Substance Control Act (TSCA) Section 6: An
Explanation of Corrosion Proof Fittings................ 125
Statements:
The Deirdre Imus Environmental Center for Pediatric
Oncology;
S. 1391--Bill to Amend the Toxic Substance Control Act
(TSCA)................................................. 123
The Synthetic Organic Chemical Manufacturers Association;
``The Toxic Substances Control Act''................... 97
TOXIC SUBSTANCES CONTROL ACT AND THE CHEMICALS MANAGEMENT PROGRAM AT
EPA
----------
WEDNESDAY, AUGUST 2, 2006
U.S. Senate,
Committee on Environment and Public Works,
Washington, DC.
The committee met, pursuant to notice, at 9:30 a.m. in room
406, Dirksen Senate Office Building, Hon. James Inhofe
(chairman of the committee) presiding.
Present: Senators Inhofe, Jeffords, Lautenberg, Carper,
Thune, Warner, Boxer.
OPENING STATEMENT OF HON. JAMES M. INHOFE, U.S. SENATOR FROM
THE STATE OF OKLAHOMA
Senator Inhofe. The hearing will come to order.
Because of a development, we are going to change the order
of things a little bit from what we had planned. We are going
to go ahead and proceed with opening statements from the panel
and then questions, and then the next panel, opening statements
and questions. Because we have to recess this hearing at 11
o'clock to reconvene at the event we are not concluded at that
time at 3 o'clock today in the same place.
So why don't we go ahead and start. We are actually going
to defer any opening statements also until 3 o'clock.
If you would like to go ahead and start, Mr. Gulliford, now
that Senator Jeffords is here, begin with your opening
statement.
[The prepared statement of Senator James M. Inhofe
follows.]
Statement of Hon. James M. Inhofe, U.S. Senator from
the State of Oklahoma
Good morning. Today's hearing is a very important one. The
Committee has not held a hearing on the chemicals management program at
EPA in more than 10 years.
There are many people who come to this hearing with a preconceived
notion that the U.S. chemicals management program is broken and that
Congress needs to completely rewrite the Toxic Substance Control Act
(TSCA). I do not come into this hearing with that assumption and I look
forward to hearing from the witnesses how they believe the statute and
the program are working. However, it is important to take a look at how
our environmental statutes are being put into practice, which is why
shining light on EPA implementation of TSCA with this hearing is so
important. Government bureaucracies only work well when there is
Congressional oversight.
The chemical industry is a crucial part of the U.S. economy. The
United States is the number one chemical producer in the world,
generating $550 billion a year and putting more than 5 million people
to work. More than 96 percent of all manufactured goods are directly
touched by chemistry.
Chemicals are the essential building blocks of products that safely
and effectively prevent, treat and cure disease; ensure the safest and
most abundant food supply in the world; purify our drinking water and
put out fires. They are the foundation for life-saving vaccines, child
safety seats, bicycle helmets, home insulation, and Kevlar vests.
Innovations in chemistry have helped to increase energy efficiency and
to make planes, fighter jets, satellites and space shuttles safer and
more secure. We are also on the cusp of new and exciting chemical
advances in the form of nanotechnology. These tiny chemicals have the
potential to cure cancers, clean up pollution, and make cars stronger
and lighter than ever before. To say that chemicals are vital is an
understatement.
There are those that suggest the mere presence of chemicals in our
bodies is cause for alarm. However, the Centers for Disease Control in
its biennial report on Human Exposure to Environmental Chemicals
states, ``just because people have an environmental chemical in their
blood or urine does not mean that the chemical causes disease. The
toxicity of a chemical is related to its concentration in addition to a
person's individual susceptibility.''
This is not to say that we should ignore human health and
environmental risks if they do, based on scientific evidence, exist.
For nearly 30 years, chemical products have been among the most
thoroughly evaluated and regulated, covered by more than a dozen
Federal laws, including TSCA. These statutes are centered on the
concept of regulating substances based on risk. I do not believe
American chemicals innovation should be stifled by Government
regulation without the clear identification of risk. We need to ensure
that we regulate chemicals based on demonstrated risk not the just the
perception or assumption of it. That ``precautionary'' concept is one
that I cannot support.
In reviewing the statute and its legislative history it appears
that the Congress was very deliberate in the powers it granted EPA
under TSCA and appropriately balanced them with burdens on the private
sector. For example, TSCA gives EPA the power to limit or prohibit the
manufacture and distribution of a substance if it is found to pose an
unreasonable risk. Chemical product makers are required to submit
information on all newly developed chemicals BEFORE they are even
manufactured. If EPA has concerns, it has the power to mandate testing
and then to control or ban it. In nearly 30 years, EPA estimates that
20,000 new chemicals have gone into commercial production by going
through the new chemicals review process and never over the objection
of EPA.
EPA has also created effective new programs to ensure that we have
chemical safety data on those existing chemicals that are produced or
imported in the United States in large quantities. This program is
called the High Production Volume (HPV) Challenge program and covers
approximately 95 percent of current U.S. chemical production and use by
volume. Through the program, seventeen types of information are being
collected, including physical-chemical properties, environmental fate,
and human and aquatic organism toxicity. This information is identical
to the internationally-agreed upon Screening Information Data Sets,
established by the 30 nations of the Organization for Economic
Cooperation and Development.
There is no shortage of strong feelings when it comes to chemicals
and how they are regulated and managed. I look forward to hearing from
our witnesses today regarding the success of the chemicals program at
EPA and its principal statute. And perhaps we will uncover
implementation problems that this committee, exercising its oversight,
can encourage the Agency to rectify.
STATEMENT OF JAMES B. GULLIFORD, ASSISTANT ADMINISTRATOR,
OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES, U.S.
ENVIRONMENTAL PROTECTION AGENCY
Mr. Gulliford. Thank you, Mr. Chairman, Senator Jeffords. I
want to thank you for the opportunity to appear today, but I
also want to thank you for your support during my recent
confirmation process. As I said during that process, I am
committed to working with each of you to fully understand the
issues, to seek solutions, to facilitate change and collaborate
on the challenges that we face.
I would also like to thank John Stephenson and his staff at
GAO for their engagement in the work of my office. While we may
not always agree on a specific path, we share the same goal of
implementing our laws in the most efficient and effective ways
possible.
I want to assure you that EPA takes very seriously its
commitment to protect human health and the environment from the
adverse effects of chemicals. I believe that TSCA has been used
effectively over the past three decades to provide those vital
protections for the American people and the environment. It is
a statute that has broad ranging authorities, and it has
allowed us to use the right tool for the right job. It is a
statute that is science-based, recognizes the role that social
and economic factors have in common sense regulation, and is
flexible enough to work in harmony with other statutes and
other risk management approaches. It gives us the authority and
the flexibility that we need to effectively manage both new and
existing chemicals as well as producers of biotechnology and
nanotechnology. As the environmental challenges that we have
faced have evolved, so too has our use of TSCA.
Leveraging our authorities under TSCA with the principles
of environmental stewardship, pollution prevention and
innovation, I believe that we have developed and maintained a
successful and comprehensive regulatory framework for chemicals
management. Let me share a few of our accomplishments.
The TSCA New Chemicals program has been recognized
nationally and internationally as a model regulatory program
for assuring the safety of new chemicals as they enter the
marketplace. Since 1979, the program has received and reviewed
over 45,000 new chemical notices. Using both regulatory and
voluntary approaches, the United States has been in a
leadership position worldwide in identifying and managing risks
associated with existing chemicals.
For example, while we are not yet a part to the POPS
treaty, although as you know we are working very diligently to
get there, the United States has already banned or severely
restricted all of the original 12 POPS chemicals before the
treaty was even drafted. Under TSCA authorities, as well as
innovative partnership approaches, the United States has
developed an extensive and publicly available data base on
chemical hazard information. We have developed sophisticated
modeling programs to predict the chemical's toxicity, as well
as peer-reviewed models to identify chemicals that may be
persistent and bioaccumulative.
We have made these programs available to industry to use in
the design and development of safer and greener new chemicals.
We are seeing that shift take place as well.
Innovative partnership programs, such as the HPV program,
have considerably increased the pace of environmental progress.
We have worked to ensure that pollution prevention is the tool
of first choice for our Nation. Stopping pollution before it
starts is clearly the most sustainable approach that we can
pursue.
Let me cite some additional accomplishments. The voluntary
stewardship programs are very important. EPA, working
cooperatively with the chemical industry and the environmental
community, launched the High Production Volume (HPV) challenge
program. This program sought commitments from chemical
manufacturers to make basic health and safety data publicly
available on about 2,800 chemicals produced in the United
States at more than 1 million pounds annually. These HPV
chemicals account for more than 93 percent of the production
volume from the chemicals that we track on the inventory. Under
the Bush administration, data has been submitted on 97 percent
of the HPV chemicals.
The Agency has in turn met its commitment to making that
information publicly available. We launched the HPV public
information system in March of this year, and will further
engage the public in a December data use conference. The HPV
program is now being extended by industry to develop these same
health and safety data on an additional 500 HPV chemicals.
There is no denying that these are real results and will lead
to both greater understanding of chemicals and better
protection of public health and the environment.
For new chemicals, when TSCA was passed in 1976, there were
62,000 chemicals placed on the TSCA inventory. Since that time,
EPA has reviewed more than 45,000 new chemical submissions.
Twenty thousand, roughly, have been added to the inventory, but
only after detailed review by EPA.
For existing chemicals, from Section 8 requirements, the
Agency has the ability to require record keeping and reporting
on a wide range of data, including production volume
information, health and safety data and substantial risk
information. This is critical information in developing risk
assessments.
We recently amended the inventory update reporting rule to
obtain exposure data on HPV chemicals to help inform the risk-
based assessments on these chemicals. In this area, more than
50,000 health and environmental studies have been submitted to
the Agency. This information is also helpful to EPA, but also a
number of other Federal agencies that use this data.
EPA has also received industry submissions under TSCA
Section 8 of substantial risk information, which alerts EPA to
critical new test data. This test data has been highly valuable
in identifying chemicals for information.
In closing, let me say we are most appreciative of today's
opportunity for the hearing, the ongoing interest of the
Committee in TSCA and the work of GAO. There are many dedicated
engineers, chemists, biologists, toxicologists, economist,
statisticians, attorneys and other civil servants who work
directly on TSCA issues for EPA. I am proud of their
achievements and proud to support their work today.
Thank you.
Senator Inhofe. Thank you, Mr. Gulliford. It is an
excellent statement.
Mr. Stephenson.
STATEMENT OF JOHN B. STEPHENSON, DIRECTOR, NATURAL RESOURCES
AND ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY OFFICE
Mr. Stephenson. Thank you, Mr. Chairman, and members of the
Committee. I am pleased to be here today to discuss our work on
EPA's implementation of the Toxic Substances Control Act.
Tens of thousands of chemicals are currently in commercial
use in the United States, and over 700 new chemicals are
introduced in commerce every year. Although these chemicals are
unquestionably essential to produce important goods and
services that we all enjoy, some may be toxic and may adversely
affect human health and/or the environment. It was in this
context that Congress enacted TSCA in 1976, authorizing EPA to
obtain information on risk of chemicals and to control those
that pose an unreasonable risk.
My testimony today is based on a report that we issued last
year, but also on past and ongoing work we have done on TSCA.
In summary, our work has shown that TSCA's authorities for
collecting data on existing chemicals do not facilitate EPA's
review process, primarily because the costly and time-consuming
burden of producing chemical risk data is on EPA rather than
the chemical industry. As a result, EPA has used its
authorities to require chemical companies to develop data for
only about 200 of the 62,000 chemicals in commerce since TSCA
was enacted in 1976.
In addition, EPA has had difficulties in using TSCA to
control the risks of specific chemicals. For example, in order
to withstand judicial scrutiny, a TSCA rule to control chemical
risk must be supported by substantial evidence that a given
chemical presents not just a substantial risk, but an
unreasonable risk to human health and the environment. In our
view, this is such a high legal standard that it inhibits EPA's
ability to ban or restrict the manufacture or use of chemicals.
In fact, EPA has issued regulations under the Act to ban or
limit the production of only five chemicals in the 30 years
since TSCA was passed.
Recognizing the need for additional information on existing
chemicals, EPA implemented the High Production Volume challenge
program, as you just heard, in the late 1990's. Under this
program, chemical companies agree to voluntarily provide test
data on chemicals produced or imported in amounts of 1 million
pounds or more per year. While the HPV challenge program is a
laudable effort and has resulted, as you heard in EPA receiving
information on 2,800 additional chemicals, EPA has not yet
fully determined how useful the information it has obtained
will be or what additional information may be required.
Even with this additional data, EPA still needs to meet
TSCA's lofty standard of demonstrating in a costly and time-
consuming rulemaking that a given chemical possesses
unreasonable risk before it can take action. Similarly, EPA's
processes for reviewing new chemicals is cumbersome. TSCA does
not require chemical companies to test new chemicals before
notifying EPA of their intent to manufacture a chemical. And
companies generally do not voluntarily perform such testing.
To compensate for this general lack of data, EPA uses
sophisticated scientific models to predict the potential
exposure and toxicity level of new chemicals. However, these
models are not always accurate predictors of risk.
Additionally, estimates of the chemical's production volume and
anticipated use can change substantially after EPA completes
its review. But the estimates do not have to be amended by
companies unless EPA promulgates a significant new use rule.
Mr. Chairman, while EPA's efforts are commendable in
encouraging companies to voluntarily provide data on existing
chemicals, the Agency's ability to manage its chemical review
program and assess chemical risks are severely inhibited by
TSCA's cumbersome authorities. EPA could review substantially
more chemicals in less time if some of the burden for assuring
the risks of chemicals was shifted from EPA to chemical
manufacturers. In that regard, we have made several
recommendations over the years for improving TSCA, such as
giving EPA additional authority under Section 4 to require
companies to develop test data based on production volumes and
the potential risk of the chemical. EPA has begun to address
some of our recommendations, but others require amendments to
TSCA.
Mr. Chairman, that concludes my summary of my statement. I
will be happy to answer questions.
Senator Inhofe. Thank you, Mr. Stephenson.
Let me ask you a question. At the very last of your
statement, you talked about the recommendation that you make to
shift more responsibility back to the companies. When you make
recommendations like that, do you take into consideration the
costs that would be involved to the ultimate consumer of the
chemicals?
Mr. Stephenson. We do. And, we think the recommendations we
have made fall in the modest category. I would say, that we
would not require the chemical industry to produce data on all
chemicals, only the few that aren't the greatest risk. We
subscribe to a risk-based approach, based on the volume of the
chemical produced and other risk factors.
Senator Inhofe. But you do consider that, then?
Mr. Stephenson. Yes.
Senator Inhofe. In a recent congressional staff briefing,
the GAO stated that companies can claim any information they
want as confidential business information and therefore be
protected from public view. Yet the Section 8 requires
companies to immediately submit information that reasonably
supports the conclusion that a substance presents ``a
substantial risk of injury or health and the environment.'' Do
you see a conflict there?
Mr. Stephenson. We think CBI claims are mostly legitimate.
They are protecting proprietary information of the company.
What we are subscribing is a broader use of even CBI
information beyond EPA to other valid users. For example, the
States may have valid reasons for seeing that data. Right now,
it is not easily provided to them or other legitimate users
because of limitation in TSCA.
Senator Inhofe. I see.
Mr. Gulliford, I took some notes at the very last of your
statement. Because I didn't get that from your submitted
statement. Is it correct, you said since 1968, well, in 1968
there were some 62,000 identified chemicals?
Mr. Gulliford. That is the number of the chemicals that
were immediately put on the list as existing chemicals.
Senator Inhofe. As existing chemicals. Now it is almost,
well, it is up another 45?
Mr. Gulliford. We reviewed 45,000 new submissions. Roughly
20,000 of those have gone onto the list.
Senator Inhofe. Some people believe that TSCA is broken and
that it doesn't provide EPA the needed authority to gather the
information necessary to adequately evaluate and regulate the
harmful chemicals. You said it was very effective in your
opening statement. Very briefly, I would just like to have you
restate that, because I want to make sure we understand what
your feeling is about their effectiveness.
Mr. Gulliford. We think TSCA is a very effective statute.
It does give us the ability to assess the likelihood of risk
during the introduction of chemicals into manufacturing or
commercial processes here in this Country. We get good
information. We have excellent models that allow us to
determine whether or not there is a likelihood of an increased
risk. TSCA gives us the authority to go to the companies and
require additional information if we feel it is appropriate. We
also have the authority, if the chemical appears to be a very
safe chemical, to allow it to proceed immediately, which is
good for industry and it is good for the environment.
Senator Inhofe. Good. Just last week, the American Bar
Association's environment section released a paper that
indicated the organization's belief that TSCA currently
provides sufficient legal authority to regulate nanoscale
chemicals. Does EPA believe it has the authority it needs to
address these chemicals? This is something people are concerned
with today.
Mr. Gulliford. We have examined the authorities very
carefully, and we do believe and we agree that TSCA has and
provides the authorities necessary to review both new and
existing nanoscale materials for use in this Country. We are
pleased that the American Bar Association came to the same
conclusion.
Senator Inhofe. All right, that is good.
Let me at this point, I understand that Senator Lautenberg
has to depart shortly. If it is all right with you, Senator
Jeffords, we can go to him for his questions.
Senator Lautenberg.
Senator Lautenberg. I appreciate that very much, Mr.
Chairman, and I know that you have a commitment that you must
keep.
What I wanted to get square, Mr. Gulliford, is whether or
not, in your remarks you talked about the number of new things
that have come up and have been reviewed. But since the passage
of TSCA, only 2 percent of the chemicals that were in use at
that time have been evaluated by the EPA. And only five of
those have been regulated. In other words, we are talking about
a base of 62,000 chemicals. Are my statements, do they reflect
the real condition?
Mr. Gulliford. What the Agency has done is, we have looked
at the number of chemicals that are in use in this Country,
those that are used in the highest volume. And we went to the
industry and asked for additional data on those high production
volume chemicals. And in doing so, we have data actually on 93
percent of these actual chemicals that are in use or produced
and used in this Country. And again, industry was very
responsive.
Senator Lautenberg. You are talking about a base of 62,000?
Mr. Gulliford. That is right. Of those 62,000 chemicals,
many of those chemicals are used in large volumes. Those are
the ones that we went to, I believe it was 2,800 of those that
are actually responsible for 93 percent of the chemistry or the
chemicals that are produced in this Country. Those are the ones
that we went to with the HPV challenge to get information,
additional information on those chemicals.
We have received that. In fact, we have received already to
date 97 percent of the information that was requested. We have
reviewed those studies and are looking now on how to proceed
forward to use that information. We have also made that
information available for public on the web to allow any users
access to that information.
Senator Lautenberg. Fundamentally you are saying you cutoff
your review at a particular volume of use? Does that include
the toxicity of these things as well? Whether or not it is high
volume or low volume, if it is terribly dangerous material,
then even a low volume might----
Mr. Gulliford. We have opportunities to look at low volume
chemicals, too, as I think was pointed out. Through the Section
8(e) requirements of TSCA, if an industry becomes aware that
there are toxicity problems with the chemical, they must report
that immediately. That has happened. We have had good examples
of that. The PFOS reports that came to us.
Senator Lautenberg. Are you satisfied with the progress
that we have made since TSCA was put into law?
Mr. Gulliford. Yes, I am.
Senator Lautenberg. You really are? There are 82,000
chemicals currently in commerce. Are they all safe?
Mr. Gulliford. There are different toxicities related to
those chemicals. The information that we have States that in
their production and in their use, the risks to the human
health and environment is acceptable.
Senator Lautenberg. Now, that, so you make that analysis
regardless of what age the person who is exposed might be? I
mean, if it is an infant or a child, doesn't that cause a
little more intensity of review?
Mr. Gulliford. Yes, it does. In fact, we have a pilot
program looking at the effect of chemicals on infants and
children. We looked at 20 chemicals that were specifically
chosen for their potential access to those chemicals to
children. We are just now getting the data from that. We have
been reporting it. We are about to issue a Federal Register
notice asking for an evaluation of the information that we have
learned about those chemicals.
So we do have the ability to look specifically at
chemistry, that is, specific to children.
Senator Lautenberg. How many of these materials would you
say that you have had a thorough enough review--how many have
you discarded because of low volume of use, do you know?
Mr. Gulliford. It is not our approach to discard any of the
chemicals.
Senator Lautenberg. I use the term loosely. Ignore.
Mr. Gulliford. Well, in terms of new chemicals, as we
review them, roughly 10 percent of the chemicals that come in
are either voluntarily not chosen to be brought into production
because the industry understands the risks associated, that our
models have identified. We also place restrictions on a lot of
the chemicals that have come.
With respect to existing chemicals, again, we looked at
those in the highest volumes of production, because again, they
are likely then to either have manufacturing exposures
associated with them or exposures in the actual use of those
chemicals. So that is why we chose those as the appropriate
first steps.
Senator Lautenberg. Mr. Chairman, with appreciation for the
time, I would just like to ask that my full opening statement
be included in the record.
Senator Inhofe. Yes.
Let me ask you, Senator, are you going to be able to come
back at 3 o'clock and participate, in the event that the
panelists are not through?
Senator Lautenberg. Lord willing.
[Laughter.]
Senator Inhofe. I think the Lord is willing.
[Laughter.]
Senator Lautenberg. Thank you.
Senator Inhofe. Your entire statement will be made a part
of the record.
[The prepared statement of Senator Lautenberg follows:]
Statement of Hon. Frank R. Lautenberg, U.S. Senator from
the State of New Jersey
Mr. Chairman, in 1962, a scientist named Rachel Carson published a
book called Silent Spring. Silent Spring was a wake-up call to the
American people. It warned us that many chemicals that were in
widespread use at that time including DDT posed threats to our health,
our environment, and to wildlife. In the aftermath of its publication,
some dangerous substances, like DDT, were banned.
And in 1976, Congress passed the Toxic Substances Control Act to
protect us from dangerous chemicals in everyday consumer products.
Unfortunately, since the passage of that law 30 years ago, we still
don't have adequate information about thousands of chemicals to which
we and our children are exposed every single day.
The American people should have a right to that information. But
court rulings have limited the effectiveness of TSCA, and tied the
hands of the EPA in its ability to evaluate the danger of chemicals in
our environment. Since the passage of the TSCA, only two percent of the
chemicals that were in use at the time have even been evaluated by the
EPA. And only five toxic substances have been regulated. Meanwhile, we
are constantly exposed to thousands of other chemicals that might or
might not be safe.
Last year the CDC issued a report evaluating the U.S. population's
exposure to 148 chemicals. In samples of blood, urine and fat tissue,
they found traces of all but two of those chemicals. Other studies have
found hundreds of industrial chemicals in the umbilical cord blood of
babies born in the United States
Clearly, the health of our children is still at risk from exposure
to industrial chemicals. That's why I have introduced the Kids Safe
Chemical Act, to update and strengthen the TSCA. Senators Jeffords and
Boxer are co-sponsors. My bill would protect children by requiring
manufacturers to provide health information to the Government before
they distribute a chemical in consumer products. It would establish
special safety standards for children, because they are especially
vulnerable to toxic exposures. And it would say that if we aren't
certain that a chemical is safe we shouldn't use our children as guinea
pigs.
I hope we can have a hearing on the Kids Safe Chemicals Act before
Congress adjourns for the year, or early in the next session of
Congress. The American people have already waited 30 years for this
information. The time for delay is past. Now it is time for meaningful
action.
Thank you Mr. Chairman.
Senator Inhofe. Senator Jeffords.
Senator Jeffords. Mr. Gulliford, on March 6th, 2006, Donald
Elliott, former EPA general counsel, appeared before the House
Committee on Energy and Commerce. Mr. Elliott testified that
EPA can no longer use TSCA Section 6 as a useful tool for
regulating chemicals, because of the high evidentiary standard.
Mr. Elliott stated, if after thousands of deaths from asbestos
exposure EPA could not regulate asbestos under Section 6, it is
virtually impossible for EPA to regulate any chemical under
Section 6.
Is this correct?
Mr. Gulliford. I am not familiar with that testimony, but
Section 6 remains a very important portion of the TSCA statute
to us. It clearly serves as a backstop to a lot of the work
that we do and a lot of the interaction that we have with
industry. The numbers are correct, and the decision on the
Fifth Circuit Court did not sustain EPA's position on the
regulation of asbestos. Still, the presence of that statute,
and we have initiated actions under that portion of the
statute, has been very helpful in allowing us to come to
agreement on voluntary actions on the part of industry to
either remove chemicals from production or change the way that
those chemicals are used.
Senator Jeffords. Mr. Gulliford, in your testimony you
discuss the High Production Volume initiative as a voluntary
mechanism for getting health and safety data on chemicals that
are produced at quantities over 1 million pounds annually. Yet
the President's proposed budget would cut $2.2 million from
this program and dramatically restricts EPA's ability to review
the data voluntarily provided.
What steps are you taking to ensure that this voluntary
information is expeditiously reviewed, so that potential public
health dangers can be quickly identified?
Mr. Gulliford. Several things. First of all, one of the
best things we did was we made all of this information public.
So not only does the Agency have access to it, but so do any
other organizations in Government or the private sector will
have, certainly, input from them as to how they interpret the
information that is there, as well as their own scientists'
review of it. I think the information will get a very careful
screening and it will allow us to again select from that, on
the basis of that, any chemicals that we believe are
appropriate to follow up with in more detail.
Senator Jeffords. Mr. Stephenson, in EPA's statement, the
Agency emphasized that they have initiated voluntary programs,
such as the High Production Volume challenge program, in order
to gather information on chemicals that generally were already
in commerce when TSCA was enacted. Will the program be
effective in assisting the Agency in its regulatory rule?
Mr. Stephenson. We are supporters of the HPV or any other
voluntary program, because it provides additional data which
would otherwise be difficult to get under the TSCA authorities.
The problem is that it is basic screening level data.
Now, I just heard today that they have asked for additional
exposure data, which is a good thing. But we don't think the
data is sufficient enough to do the analysis to determine the
risk of chemicals at this point. There is a lot of analysis
that needs to be going on. While this HPV program came into
place in 1990, data is still coming in. There is still data on
250 plus chemicals that has not come in.
So it is too soon to tell how useful this information will
be. This does not negate the need for making TSCA easier to
use, in our opinion.
Senator Jeffords. Thank you.
Senator Inhofe. Senator Carper, would you like to be
recognized for questions?
Senator Carper. Not at this time, thanks.
Senator Inhofe. We are about through with this panel.
Senator Carper. Let's let them go.
Senator Inhofe. All right. I have one last question, Mr.
Gulliford. As we all know, the testing for pesticides and food
additives are in a different statute. Would you kind of explain
the reason behind that and the different types of testing that
you have under TSCA, as opposed to the statutes that regulate
pesticides and food additives?
Mr. Gulliford. Yes, thank you, Mr. Chairman. The TSCA and
the FIFRA statutes are two fundamentally different statutes,
fundamentally different approaches to regulation. In fact,
FIFRA acts as a licensing agent or a licensing process for
pesticides, which we generally assume to have active
ingredients and to be biologically active.
Therefore, we ask for the information necessary to
determine what the likely impacts of those actions might be on
biological communities or human health, as well as the
environment. So we do ask for very specific data to enable us
to make those judgments, make those decisions relative to FIFRA
and pesticides.
TSCA, on the other hand, deals with industrial chemicals.
They are not designed for food purposes or food uses. So we
place in effect through TSCA an assessment process to measure
the potential risk that those chemicals may have, either
through their manufacture or through their use in commerce.
Then we use that information to determine whether or not there
is a probable risk to human health or the environment. And then
given when we find that, we can take an action then to
appropriately either gain additional information necessary to
regulate those uses or to regulate on the basis of the
information that we have.
So they are very fundamentally different statutes for very
different purposes.
Senator Inhofe. Thank you for that distinction.
Mr. Gulliford, Mr. Stephenson, thank you very much for
being here. Let me just say that there will be questions for
the record. Also there will be statements, opening statements,
that will be submitted for the record for those that didn't
have a chance to do it. We would ask that you review those when
you receive them. Thank you very much for your appearance.
We will call up the second panel. Before we do, I would
like to recognize Cori Lucero. Cori, stand up, hold your hand
up there, let them see who you are. This is going to be her
last hearing. She has been with us for a couple of years now.
We were expecting she would be here a lot longer than that, but
she has better things to do, I guess.
[Laughter.]
Senator Inhofe. She has done a great job, and she is going
to be replaced by Steve Chapman over here. Steve, you smile too
much for that job. You have to be mean.
[Laughter.]
Senator Inhofe. Cori, you have done a great job, you really
have. It has been a joy having you around. Thank you.
Senator Carper, we checked with staff, there was an
unfortunate death and the funeral takes place at 11 o'clock
today. So we had planned to go ahead with our witnesses and
then come back at 3 o'clock, take a recess at 11 o'clock and
come back at 3 o'clock. If you would be able to do that, in
your schedule, that would be great. We will see how far along
we get between now and 11 o'clock.
Senator Carper. We have a markup in my Banking Committee at
10 o'clock, and they have asked us to come, so I am going to
slip out for a while, but I will come back.
Senator Inhofe. Yes. All right. I understand that.
Our next panel is William Rawson, the Chair, Environment,
Land and Resources Department, partner in Latham and Watkins;
Lynn Goldman, Johns Hopkins University, Bloomberg School of
Public Health; Michael Walls, Managing Director of Regulatory
and Technical Affairs, American Chemistry Council; Michael
Wilson, Center for Occupational and Environmental Health,
School of Public Health, University of California, Berkeley;
and Gail Charnley, President, HealthRisk Strategies.
So in that order, we will start with opening statements,
with you, Mr. Rawson. And we would like to ask you to try to
stay within your timeframe, all five of you. Then we will
proceed to questions. Your entire statements will be made part
of the record.
Mr. Rawson.
STATEMENT OF WILLIAM K. RAWSON, PARTNER AND CHAIR OF THE
ENVIRONMENT, LAND AND RESOURCES DEPARTMENT, LATHAM AND WATKINS
Mr. Rawson. Mr. Chairman, distinguished members of the
Committee, and staff, good morning.
I would like to begin by thanking you for giving me the
opportunity to speak this morning and to contribute to the
public discourse on the Toxic Substances Control Act. I hope
that my written and oral testimony will prove useful.
The question before the Committee today, at least in part,
is whether the provisions of TSCA give EPA the authority it
requires to meet the objectives set forth in the Act. I believe
the answer to that question is yes. In my judgment, TSCA is a
well crafted statute that has stood the test of time well.
My written testimony focuses on three sections of the
statute, Section 5, pertaining to the review, testing and
control of new chemicals, Section 4, pertaining to the testing
of existing chemicals, and Section 6, pertaining to the
regulation of existing chemicals. In my oral testimony, I will
just speak briefly to a few key points.
Before I do that, I would like to express my personal
strong support for EPA's mission. I have worked with many EPA
managers and staff over the years, very closely, on a number of
very challenging issues. And I have great respect for their
efforts in support of the Agency's mission.
With respect to the regulation of new chemicals, the
strength of TSCA lies in its flexibility. Section 5 gives EPA
the flexibility to vary its assessments of new chemicals
according to the attributes and expected uses of each
substance.
The majority of new chemical substances pose little or no
risk to health or the environment, and either qualify for an
exemption from the pre-manufacture notice requirements or are
readily determined to have low toxicity, based on information
submitted with the PMN, use of EPA models, and comparison to
previously approved chemicals.
Where appropriate, however, Section 5 does give EPA
authority to prohibit or limit the manufacture and use of new
chemicals. EPA has used this authority provided under Section 6
to compel testing for many new chemical substances and also to
impose restrictions or controls. In fact, EPA has imposed
substantial controls on or effectively prohibited the
manufacture of more than 3,500 chemical substances since TSCA
was enacted.
Thus, in my judgment, the provisions of Section 5 appear
well designed to achieve congressional intent. EPA has the
necessary flexibility and discretion to give each new chemical
substance the level of scrutiny it merits and to impose such
restrictions on manufacture and use as are necessary to prevent
unreasonable risks to health and the environment.
Section 4 grants EPA the authority to require testing of
existing chemicals. EPA has required testing of more than 200
substances under Section 4 and many more substances have been
reviewed and determined to be a low priority for testing or not
to require testing at all. Also as described in the earlier
testimony, a large number of chemicals have been tested under
voluntary programs by industry.
There has been some suggestion that the findings required
by Section 4 are overly burdensome on EPA, thus rendering
Section 4 ineffective. I personally find these arguments
unpersuasive. In my judgment, EPA's burden to support a test
rule in fact is quite modest. EPA only needs to show that a
chemical may present an unreasonable risk or that it may be
released to the environment in substantial quantities, or that
there is or may be significant or substantial human exposure.
And the threshold for making those findings in fact is quite
low.
That said, I do believe EPA could improve its performance
under Section 4 in a number of ways. Relatively few test rules
have been issued in recent years. I realize that is in part
because of the substantial effort devoted to the HPV challenge
program. It is also the case that a number of testing proposals
have languished unfinished for extended periods of time. In my
written testimony, I have offered some specific suggestions for
how implementation of Section 4 might be improved. But I do not
believe the statutory criteria need to be modified. In my
judgment, they provide a sound scientific basis for making
appropriate testing decisions.
Section 6 gives EPA authority to regulate existing
chemicals. The EPA used this authority effectively in the early
days of TSCA to in fact regulate several substances under
Section 6. But as has been noted, EPA's authority under Section
6 and the effectiveness of that Section has been called into
question by the decision in Corrosion Proof Fittings. In that
case, the court struck down EPA's ban on certain asbestos-
containing products.
The failures in the asbestos rulemaking, however, in my
judgment, were failures in implementation and do not reflect
deficiencies in the statute. As the court explained in its
decision, EPA's product-specific bans in that case were
rejected, because EPA specifically in that rulemaking used
flawed procedures and flawed methodology. The details are set
forth in my written testimony.
I say this not to be critical of the Agency, but because I
think it is important that the decision not be misunderstood.
In my judgment, the lesson of Corrosion Proof Fittings is not
that Section 6 does not work or cannot work. Rather, the lesson
is that no matter what the product, when acting under Section
6, EPA of course must use proper procedures, consider relevant
factors and provide an adequate explanation for its decision.
The Agency does that, in my judgment. Section 6 can and will
work, as it did several times during the early days of TSCA,
and the Agency's decisions will receive deferential treatment
by the courts.
In my judgment, GAO's revisions to Section 6 are not
necessary to support effective regulation, nor would they
improve, in my judgment, the statutory framework for making
regulatory decisions.
Senator Inhofe. You will have to wind up, Mr. Rawson.
Mr. Rawson. Thank you.
So in conclusion, I would just like to say that the Agency
has accomplished a great deal under TSCA since its enactment.
While there is always room for improvement, I do not believe
that amendments to TSCA are required. I believe TSCA does
provide EPA with ample authority to meet the objectives of the
Act.
Thank you.
Senator Inhofe. Thank you, Mr. Rawson.
Ms. Goldman.
STATEMENT OF LYNN R. GOLDMAN, M.D., M.P.H., PROFESSOR,
ENVIRONMENTAL HEALTH SCIENCES, JOHNS HOPKINS UNIVERSITY,
BLOOMBERG SCHOOL OF PUBLIC HEALTH
Dr. Goldman. Thank you very much. I very much appreciate,
Mr. Chairman, the opportunity to testify before your Committee
today, and I have submitted my full testimony for the record. I
am going to give a very brief summary of it.
As you probably are aware, I am a pediatrician by training.
I served for more than 6 years as the Assistant Administrator
for Prevention, Pesticides and Toxic Substances at the U.S.
EPA. So in that position, I was responsible for the
implementation of the Toxic Substances Control Act. I hope I
can give you some insights that are more kind of from the
inside, how it really works when you are trying to make this
law work, which of course as a public health professional I was
very committed to doing.
I should say in opening that I have a tremendous amount of
respect for the U.S. chemical industry. It is very important to
our economy, and it is important to our way of life. And as a
former regulator, that is something that one does not take
lightly. I also have a tremendous amount of respect and
admiration for the people who work at the EPA. I worked with
people there who were highly trained professionals, very
committed, and did the best that they could do. But
unfortunately, they have not been given the tools nor the
resources that they need to do their jobs properly.
There is so much in my written testimony that I can barely
cover it in the space of 5 minutes. So what I am going to do is
very briefly touch on the nine areas that I think are of
concern, the first being the area of risk evaluation. We
believe as a society we should base our decisions on risk. To
understand risk, you need to understand hazards and exposure,
and TSCA tells us about neither.
The second area is protection of vulnerable populations.
Can we adequately protect children and other vulnerable
populations? TSCA has no provisions, unlike most modern
environmental statutes, for doing so.
The third area is risk management, can we manage risks
under TSCA? And the answer is, no, we cannot. Despite what you
may hear from others, the ``least burdensome'' requirement is
too high a hurdle; he professional attorneys, scientists,
economists within EPA recognize that this burden is too high.
That is why there are no Section 6 rules on the books since
Corrosion Fittings.
The fourth area is one of precaution. Does TSCA allow us to
take precaution? The answer is no. Because the standard of
unreasonable risk does not tilt enough toward protection of
health and the environment.
Area No. five is assessment of new chemicals. There are
great people in the New Chemicals office, and they make a great
effort. The tools are insufficient. Structural information and
use of computer modeling misses a lot of chronic risks. Studies
have shown this. We know that this is not an adequate way of
assessing the risks.
Sixth is right to know and problems with TSCA's
confidential business information provisions. While CBI
protection is very important, these provisions allow you to
claim as CBI the name of the chemical and where it is made:
even the States can't find that out. As an ex-State official,
(I worked in public health for the State of California.) I find
this to be unacceptable. When I was at EPA, I could not tell a
State environmental official what was in that CBI information.
Seventh is pollution prevention. TSCA does not contain
provisions to promote the development of new and safer
alternatives.
Eighth in the area of international management of
chemicals, EPA has slipped in its leadership in the
international arena. We are not a part of the POPS nor the PIC
convention. And this is of great concern, not only from the
standpoint of protection of health and the environment, but
also for our economy. Our position of leadership in the world
and the view that others in the world have of our products, the
credibility of our process is at risk because we are not full
participants in these foray.
Ninth is that TSCA does not establish clear priorities for
EPA in regulating toxic chemicals.
In conclusion, I believe that overhaul of TSCA is long
overdue. It has been 30 years since Congress enacted it. It has
never been reauthorized. I think that the bills that are going
through State legislatures to ban individual chemicals are a
very bad symptom, along with the fact that EPA is falling
behind globally. Further, procedures for new chemicals are not
adequate. Even though EPA has the authority to regulate
nanotechnology, how do the old QSAR (Quantitative Structure
Activity) models apply to nanotech? They don't at all.
Of fundamental importance as well as the credibility and
trust in the Federal process. If States are moving out on their
own, I think that that speaks for itself.
I also know, from my experience as a regulator, that one
should not undertake such an overhaul without a process that
brings all the parties together. And I want to go back to my
first point about the deep respect that I have for the U.S.
chemical industry. Industry has a role to play, along with
environmental groups, public health people, chemical experts.
There needs to be a process, much like the process that the
European Union has gone through, to define, what chemical
regulation for the 21st century should look like in the United
States?
Thank you.
Senator Inhofe. Thank you, Dr. Goldman, for an excellent,
well-thought and organized statement.
Mr. Walls.
STATEMENT OF MICHAEL P. WALLS, MANAGING DIRECTOR OF REGULATORY
AND TECHNICAL AFFAIRS, AMERICAN CHEMISTRY COUNCIL
Mr. Walls. Good morning, Mr. Chairman, Senator Jeffords.
Thank you very much for the opportunity to be here.
We appreciate this opportunity to reiterate the U.S.
chemical industry's belief that the Toxic Substances Control
Act provides a strong, robust regulatory framework for health
and environmental protection in the United States.
The member companies of the American Chemistry Council are
on the cutting edge of technological innovation and progress.
Our products provide safe drinking water, life-saving
medicines, a safe food supply and jobs throughout the Nation.
Our member companies are committed to the safe management and
use of their products through compliance with TSCA, other U.S.
Federal statutes and their own product stewardship initiatives.
We have three major points to make today. First, innovation
starts in the chemical industry. It is critical that the U.S.
chemical regulatory framework continue to promote innovation
and the technological prowess that has characterized our
industry.
Second, our industry invests billions in research and
development in health, safety and environmental protection even
before our products reach the market. That investment must be
protected by a strong regulatory framework.
Third, as science and technology develop, new questions
will arise about hazards, exposures and risks to chemicals. It
is vital that the U.S. chemical regulatory framework be robust
enough to address those future concerns.
In our view, TSCA meets each and every one of these
objectives. The statute itself has proven effective and
remarkably adaptable to changing needs and priorities. TSCA
works, and it works well, and the facts support that
conclusion.
TSCA allows the Government to obtain information on
unreasonable risks, assess that information and take
appropriate action to address them. It empowers EPA with
considerable authority, even the authority adopt non-regulatory
programs that complement its policy objectives.
TSCA has helped establish EPA as a global leader in
developing tools and programs to understand more about
chemicals faster than ever before. EPA developed and spread the
introduction of predictive tools, like structure activity
relationship analysis and other predictive models. EPA has
pioneered time, money and animal saving techniques, such as
category approaches. These are also tangible measures of EPA's
success under TSCA.
TSCA fuels innovation. More new chemical applications are
filed under TSCA than under any other chemical regulatory
system. The industry spends more than $23 billion a year on
research and development. Technology is a driving force in our
industry, and even as high natural gas prices affect jobs and
profitability in our industry, we continue to invest in the
future.
My second point is that the industry's significant
investment in health, safety and environmental measures should
be protected by a strong but flexible regulatory system. TSCA,
as you heard, protects appropriate claims of confidential
business information and strikes a balance between the
industry's interests in competitive information and the public
interest in oversight of EPA's TSCA activities.
Moreover, that framework under TSCA has allowed the
industry to bring forward a considerable amount of information
resident in company files. You heard about the High Production
Volume chemical program already from a number of other
witnesses. The important point with the HPV program is that the
TSCA framework has allowed the chemical industry to be
responsive to concerns about chemical hazards, uses and
exposures, even without a regulatory mandate.
My final point is that the chemical regulatory framework
must be robust enough to deal with future challenges. In this
respect again TSCA meets the test. Concerns about children's
health, bio-monitoring information and nanotechnology not only
can be addressed under TSCA, they are being addressed. EPA has
the appropriate authority to require new information about
risks, to promote research or to require testing or even to
craft new pilot programs on issues like nanotechnology.
Has the chemical industry always agreed with EPA on its
implementation decisions under TSCA? Clearly, that has not been
the case. Do we agree that there are areas where EPA's
implementation of the statute can be improved? We surely do. We
welcome the dialog on how to improve understanding about
chemicals and ensure that EPA can implement its statutory
authority. We have a track record of dialog with the Agency on
these issues, as well as with other stakeholders. And that, I
submit, is also evidence that TSCA works and it works well.
Thank you for the opportunity to reflect our views on TSCA.
I will look forward to your questions.
Senator Inhofe. Thank you, Mr. Walls.
Dr. Wilson.
STATEMENT OF MICHAEL P. WILSON, PH.D., M.P.H., UNIVERSITY OF
CALIFORNIA, BERKELEY
Mr. Wilson. Mr. Chairman, members of the Committee, thank
you very much for inviting me to the hearing today. I am an
Assistant Research Scientist at the University of California
Berkeley, and I am the lead author of the U.C. report to the
California legislature entitled Green Chemistry in California:
A Framework for Leadership in Chemicals Policy and Innovation.
The report illustrates that California, like other States,
is facing an array of chemical problems. On the other hand, the
report finds that a modern chemicals policy that responds to
these problems has the potential to deliver an extraordinary
set of benefits to the public and to businesses. It could build
the foundation for a sustainable chemical industry, it could
prevent costly chemical damage, and it could position the
United States to become a global leader in green chemistry, the
design, production and use of chemicals that are inherently
safer for human health and the environment.
Crafting a modern chemicals policy of this type will
require that we correct longstanding deficiencies in the Toxic
Substances Control Act. The report summarizes the results of
several important analyses that have all reached the same
conclusions about the deficiencies in TSCA. Our report points
out that these deficiencies have produced a flawed chemicals
market in the United States that has on the one hand allowed
the producers of hazardous chemicals to remain competitive in
the market, and on the other, has dampened motivation of the
industry and entrepreneurs to vigorously invest in green
chemistry technology innovation.
The report describes a data gap, a safety gap and a
technology gap that have emerged in the U.S. chemicals market
as a result of TSCA. The data gap refers to the lack of
information in the market on the safety of chemicals. TSCA does
not require producers to generate and distribute adequate
information on the safety of their products. Markets cannot
function efficiently without information, and the chemicals
market is no exception.
The safety gap refers to the well-documented barriers that
EPA faces in its efforts to assess the hazards of chemicals and
control those of greatest concern. The technology gap refers to
the potential for the United States to fall behind globally in
the development of green chemistry technologies.
Mr. Chairman, a properly functioning chemicals market would
amplify the positive contributions of the chemical industry to
our society, while steadily reducing its negative impacts. It
is widely recognized that the chemical industry generates
extraordinary benefits to our economy and to our modern way of
life. Yet over the next 25 years, we will spend up to $250
billion cleaning up hazardous waste sites, a portion of which
are attributable to chemicals. This year alone, some 23,000
Californians will be diagnosed with a deadly chronic disease
attributable to chemical exposures on the job.
The effects of exposures that occur during fetal and child
development are of course of great concern. It makes sense to
prevent these negative impacts and motivate the industry to
focus its enormous talent on the design and production of safer
chemicals, on green chemistry. This will require that we close
the data and safety gaps through a fundamental restructuring of
TSCA.
We can close the data gap by requiring chemical producers
to generate and distribute information on the safety of their
products. We can close the safety gap by providing Government
with better tools to efficiently evaluate chemicals and reduce
the commercial circulation of the most dangerous ones. These
steps alone will create a market that favors investment in
green chemistry, which will gradually close the technology gap.
We can go further by offering a range of incentives to
companies that implement green chemistry solutions, and we can
fund green chemistry research and education. This will support
our leading companies, it will save us enormous public health
expenditures, and it will put us at the forefront of global
developments in green chemistry.
Our report recommends the importance of bringing
Government, industry, advocates and the scientific community
together into a task force to identify and prioritize and frame
a chemicals policy in California.
Mr. Chairman, members of the Committee, thank you very much
for your attention today. And thank you again for inviting me
to this important hearing. I am pleased to answer any questions
you might have.
Senator Inhofe. Thank you, Dr. Wilson.
Dr. Charnley.
STATEMENT OF GAIL CHARNLEY, PH.D., PRESIDENT, HEALTHRISK
STRATEGIES
Ms. Charnley. Chairman Inhofe, other Senators, thank you
for the opportunity to speak with you this morning. I am basing
my statement on 30 years of experience as a toxicologist and
risk analyst studying the relationships between chemical
exposures and public health outcomes.
In its 1997 final report, the bipartisan Presidential-
congressional Commission on Risk Assessment and Risk
Management, for which I served as executive director,
recommended a sustained stakeholder process should be initiated
to review TSCA and its implementation. As Administrator
Gulliford has pointed out this morning, a variety of activities
has taken place since then that is consistent with the
commission's recommendation, such as the establishment of the
National Pollution Prevention and Toxics Advisory Committee,
the High Production Volume challenge program, and the new
extended program in the Voluntary Children's Chemical
Evaluation program.
I believe that those programs demonstrate that voluntary,
multi-stakeholder initiatives are both possible and succeeding
under the umbrella of TSCA.
Basic toxicity data have been generated for most of the
chemicals in commerce by volume, and research efforts have
provided information about children's exposures and
susceptibilities that is incorporated into risk assessment and
chemical standard setting. These efforts continue to generate
data that will contribute to better and better chemical
regulation and to safer, healthier children.
To the extent they are available, environmental and bio-
monitoring trend data demonstrate that overall, emissions and
body burdens of chemical contaminants in the United States
continue to decline. While the public is understandably
concerned about the detection of chemicals, bio-monitoring data
that provide information solely about trace levels of
substances in blood or urine cannot be used to draw conclusions
about the likelihood of disease, except in very rare cases.
Exposure does not imply toxicity, and presuming that any
chemical exposure is dangerous and that any chemical hazard
poses a risk is inappropriate and not supported by science. The
dose makes the poison, after all. In addition, focusing solely
on the presence of trace levels of chemicals misses the
substantial contributions that genetics and economics, social,
cultural, behavioral and psychological factors contribute to
risk.
Furthermore, current EPA methods for setting standards to
limit chemical exposures are precautionary, and account for the
possibility that children can be more susceptible than adults
to chemical toxicity. If no data are available with which to
evaluate risks to children, standard practice is to use extra
safety factors that make exposure limits more stringent. If
data are available with which to evaluate risks to children,
those data are considered as part of the standard setting
process.
The HPV chemical testing program convened under TSCA uses a
tiered approach to testing. The advantage of the tiered testing
approach is that it helps identify early on those chemicals
that are more likely to pose a particular risk to children than
others, so that those chemicals get higher priority testing at
the next year. My point is that although, that through the HPV
and Voluntary Children's Chemical Testing programs, both
convened under the umbrella of TSCA, there is a big focus on
identifying chemicals that might pose a particular risk to
children and in any case, when EPA restricts chemical
exposures, it errs on the side of precaution to protect
children and other potentially vulnerable people.
Finally, our environment is cleaner and our food and water
is safer and people are healthier than ever before. Our
environmental programs are evidently working overall. Even the
New York Times noted on Sunday that people alive today in
developed countries are healthier than they used to be, live
longer, get heart disease and other chronic illnesses later in
life than they used to, experience less disability and have
higher IQs Those improvements are attributed to much-improved
maternal and childhood health.
While I think that testing chemicals and regulating
chemical exposures are certainly very important, I think our
obsession with trace contaminants is out of proportion to their
likely public health risk. And I think it would be nice if we
recognized our environmental accomplishments.
Thank you.
Senator Inhofe. Thank you, Dr. Charnley.
Let me start off, Dr. Goldman, you have suggested that the
High Production Volume production is inadequate and that we
need more aggressive testing. Would this be testing that would
involve lab animals? What type of testing are you referring to?
Dr. Goldman. In terms of the High Production Volume
chemical program, when I was at the EPA I was among those who
brought the parties together to create the agreement to do the
program. I am very much in support of it. I think that we
definitely need screening level information on the chemicals in
highest production in the Country.
But we need to keep it in perspective. It is only screening
data. If I am taking care of you, if you were my patient, and I
did this screen on you----
Senator Inhofe. No, let me just ask you to get right to the
answer. Would it require more lab animal testing in order to be
more aggressive?
Dr. Goldman. You need to have a process first that tells
you which findings from the screening indicate that there is a
risk. And then, based on that, you gather further information,
which may or may not be information derived from examinations
in animals. It might lab animals, it might involve other kinds
of data gathering, depending on what the results of the
screening show.
Senator Inhofe. OK. The reason I am asking the question, we
have had several hearings now, I think a lot of people are not
aware that the No. 1 and No. 2 domestic violence, according to
the, I am not sure who made the evaluation, I guess it was the
Department of Homeland Security, is some of the animal rights
groups. We have had several Committee hearings on this, where
they have come in and talked about actually encouraging people
to murder people that are testing, using animals to test.
It has been really a pretty tough thing to deal with. So I
just want to keep that in mind, because we do have a real
serious problem there that we have been trying to address.
Dr. Charnley, you made a statement, and I think it is worth
elaborating on a little bit. You said the dose makes the
poison. There are a lot of people who believe just the chemical
alone is something that is the problem. There is a chart up
here, I was going to use this in my opening statement, I didn't
get a chance to do it. This chart is a children's multi-vitamin
chart. It shows, for example, copper, which is essential for
forming red blood cells and boost the body's ability to mend
tissue. Copper is regulated as a secondary drinking water
contaminant. Or Vitamin D, an important nutrient added to milk.
Too much Vitamin D may lead to kidney stones, high blood
pressure, et cetera.
As a toxicologist, does science support the assumption that
any chemical exposure is dangerous? I would assume not.
Ms. Charnley. That is correct, no, sir, it does not. As I
pointed out in my testimony, the dose does make the poison. At
the right doses, vitamins and aspirin might even make you feel
better, but they won't harm you. If you take too much of them,
then they will make you sick.
Basically the same is true for chemicals. As the CDC
States, the presence of a chemical in a blood or urine specimen
does not indicate a chemically caused diseases or risk.
Senator Inhofe. I think that is worth bringing out, because
so many people are of the opinion that if it exists at all,
that that alone is dangerous.
Mr. Rawson, under Section 6, the EPA has to show that it is
using the least burdensome requirement, least burdensome
requirement. Now, some people have argued here on this panel
that we need a lower standard. I would ask you if you consider
that to be a very difficult requirement for the EPA to meet,
least burdensome requirement.
Mr. Rawson. I consider it a reasonable standard. I think it
is reasonable to expect the Agency to consider alternative
approaches and to choose the approach that does protect health
and the environment, but while imposing the least burdensome
requirements. And stated differently, if something less than a
ban will do the job, then I think EPA should use it. I will
just add quickly, that is what happened with acrylamide grout.
EPA proposed a ban under Section 6, based on a concern for
worker exposure. And the industry came forward and developed a
new type of personal protective equipment that eliminated the
concern. Therefore, the rule, the proposal was withdrawn. But
to me, that is a win-win under Section 6, even though no final
action was taken, because a less burdensome approach solved the
problem than the proposed ban.
Senator Inhofe. Dr. Goldman, the reason I brought that up,
PETA has stated that for each chemical that it would take about
9,000 lab animals per chemical. I don't want you to answer now,
but for the record, I would like to get into this thing as to
how more aggressive testing could take place without that, or
be a little more specific on that. Because this is a problem we
are dealing with quite a bit.
Senator Jeffords.
Senator Jeffords. Dr. Goldman, you were involved in the
Johns Hopkins study that evaluated the exposure of babies to
certain industrial chemicals. How did the findings of this
study support your testimony in favor of TSCA requiring the
protection of sensitive populations, especially children?
Dr. Goldman. We are still involved in this work. What we
find is many, many industrial chemicals that are in the cord
blood of babies when they are born. For most of these, we have
no information in the toxicology or the epidemiology literature
about what they are doing to children. And as concerned as I am
about animals, and by the way, the 9,000 number is a gross
exaggeration----
Senator Inhofe. I agree.
Dr. Goldman. I am very concerned about children. And I
don't think children should be our test species for chemicals.
We should know before we are exposing our children to chemicals
what those chemicals may do to them.
Senator Jeffords. Dr. Charnley, in your testimony you claim
that children are not more susceptible to chemical toxicity
than adults. How can you reconcile this conclusion in light of
the fact that children, pound for pound, breathe more air,
drink more water and eat more food than adults and thus are
more exposed to whatever toxins are present in the media?
Ms. Charnley. First of all, I did not say that children are
not more sensitive. I think that children of course are
probably in most cases more highly exposed. But I think that as
to vulnerability, they can be either less than, more than or
the same in terms of vulnerability, depending on the chemical
and the exposure situation.
When EPA regulates a chemical for which toxicity
information about children's sensitivity is available, then
they use that information when they set chemical standards. If
it is not available, then EPA uses more stringent approaches in
order to protect children and other potentially vulnerable
populations.
Senator Jeffords. Dr. Wilson, in your testimony you noted
that TSCA has created data, safety and technology gaps in the
U.S. chemicals market. Can these gaps be adequately addressed
by the States or is a Federal overhaul of TSCA necessary?
Mr. Wilson. I think an overhaul of TSCA is necessary. At
this point in the State of California, for example, there is no
State Agency that knows, has information on the identity of
chemicals that are being introduced into commercial circulation
in the State, where those chemicals are being used and in what
volume, by whom, for what purpose or how people might be
exposed. That presents a fundamental barrier to the States in
terms of prioritizing and acting on chemical hazards. I think
as Dr. Goldman mentioned, what we are seeing in California,
last year it was 35 bills introduced into the legislature to
address chemical-related problems. It is a symptom in a way of
the lack of information that our State agencies have. What is
needed, as I said, is an overhaul of TSCA that can get that
information out to the States, so that we can act
appropriately.
Senator Jeffords. Mr. Walls, the Kids Safe Chemical bill
that I drafted with Senator Lautenberg would require
manufacturers to certify that their products meet the bill's
safety standard or that they do not have enough information.
Does the chemical industry support this public right to know
provision?
Mr. Walls. Senator, we do not support the Kids Safe
Chemicals legislation that you introduced. We believe that
under the Toxic Substances Control Act, EPA has sufficient
authority to address children's health issues.
I should also note that children's health issues are a
priority for our industry. Our industry stepped up, volunteered
to participate in the Voluntary Children's Chemical Evaluation
program in order to help us and to help EPA understand exactly
what are the potential children's exposures to chemicals and
how we can properly assess those exposures and take some
decisive action. As you heard from Mr. Gulliford, EPA intends
to very soon issue a Federal register notice on an evaluation
of that program, so that we can start to apply it on a broader
basis.
Senator Jeffords. Thank you.
Senator Inhofe. Thank you, Senator Jeffords.
Senator Thune.
Senator Thune. Thank you, Mr. Chairman. I want to thank the
panel for your testimony and for your input and for being here
today and responding to questions.
I would like to direct a couple of questions, if I might,
to Mr. Rawson. First question would be this: was TSCA designed
to eliminate all risks, in your judgment?
Mr. Rawson. No, Senator. We do not live in a zero-risk
world. TSCA is designed to eliminate unreasonable risks.
But I would like to point out that that is a very health
protective standard. Because when EPA evaluates risk, it uses a
very conservative approach, both in assessing intrinsic hazard
and assessing exposure. Typically EPA will assume worst case
exposure. So for example, lifetime use of a product or spending
70 years at the fence line of the highest emitter.
On the hazard side, EPA will use uncertainty factors and
will assume that humans are more sensitive than animals and
that some humans are more sensitive than others. So typically,
EPA will not be satisfied unless maximum theoretical exposures
are 100-or 1,000fold below levels at which no effects have been
seen in animals.
I do want to emphasize that there is considerable health
protective assumptions built into the unreasonable risk
standard.
Senator Thune. You in your testimony indicated that it
would be impractical to treat all chemicals alike during the
review process. Could you elaborate on that a little bit?
Mr. Rawson. Yes, Senator. Very simply, not all chemicals
are alike. EPA has indicated that a majority of new chemicals
that are presented to the Agency through the pre-manufacture
notice process are readily set aside based on screening
information, comparison to previously approved chemicals, use
of EPA models and the like, which I think are quite
sophisticated and quite adequate.
There are of course some chemicals that require closer
scrutiny. That is where Section 5(e) comes into play and EPA's
authority to compel testing or to impose restrictions or
controls. So I think that it is appropriate to recognize, as
TSCA does, that not all chemicals are alike, and to give EPA
the flexibility to devote extensive resources where appropriate
and not where not appropriate. It is important to emphasize
that if we took a one size fits all approach, EPA would end up
spending a lot of time on low priority chemicals and that time
would not then be available to address higher priority issues.
Senator Thune. What safeguards exist to ensure that
chemical companies don't cut corners when they bring new
chemicals to the market?
Mr. Rawson. Senator, the bottom line there is that a new
chemical can't get to market unless it has EPA's approval,
unless it qualifies for an exemption, in other words, it has
already been determined to be part of a category that doesn't
really warrant pre-manufacture review. But if it doesn't fall
into an exemption, then the manufacturer has to submit a pre-
manufacture notice and ultimately meet EPA's data requirements.
If it is a chemical that EPA feels requires close scrutiny,
that falls into one of the many categories of concern that the
Agency has identified, the company is going to have to provide
the data that EPA wants.
As I said in my testimony and also my written testimony,
EPA has effectively restricted or prohibited the manufacture of
more than 3,500 chemicals since TSCA has been enacted. And no
company, to my knowledge, has ever taken EPA to court on any
5(e) order. In every case, the company has either met EPA's
requirements or withdrawn the PMN.
Senator Thune. Mr. Walls, there has been some discussion
today about the precautionary standard. Is there empirical data
that exists to support changing from a risk-based approach
along the liens of what is used here to more of the approach
that is used in the European model?
Mr. Walls. Senator, we believe that the existing risk-based
decisionmaking standard in TSCA is in fact a precautionary
approach. But if by precautionary standard you mean a hazard-
based standard, we believe there is no empirical data for that
suggestion.
Senator Thune. Mr. Wilson referenced in his testimony this
technology gap in the United States. Would you agree that there
is a lack of innovation that exists in the United States today?
Mr. Walls. Senator, I was very interested in Mr. Wilson's
testimony about that. In fact, one-quarter of all patents
issued in the United States are related to chemistry. That is
not evidence of a technology gap. We spend $23 billion in
research and development every year in our industry. That is
not evidence of a technology gap. That is evidence of an
industry that is committed to technological innovation and
progress.
Our companies are also consistently recognized in the
Presidential Green Chemistry awards as innovators in chemistry.
That is a tradition that our industry has established and one
we intend to continue.
Senator Thune. One final question for Ms. Charnley. There
was a recent National Academy of Science report on bio-
monitoring that suggested that we cannot assume that the mere
presence of a chemical will lead to adverse health effects. As
a toxicologist, can you comment on bio-monitoring and its
usefulness and any limitations that it might present?
Ms. Charnley. Sure. I think that is correct, that bio-
monitoring data that provide information solely about trace
levels of chemicals in a blood or urine sample at a single
point in time do not allow us to draw conclusions about the
likelihood of disease. What that information can let us do is
determine that exposure has occurred, to follow trends in
exposure over time, to identify unusually exposed individuals,
and sometimes to help us clarify the relationship between
exposure and dose. But they do not provide information with
regard to the risk or likelihood of ill health, except in some
rare cases.
Our analytic abilities are now allowing us to detect
smaller and smaller amounts of more and more chemicals, but
that does not mean that we are at greater and greater risk of
chemical-related disease.
Senator Thune. I see, Mr. Chairman, my time is up. So I
thank you all very much for your responses.
Senator Inhofe. Thank you, Senator Thune.
Senator Boxer.
Senator Boxer. Thank you, Mr. Chairman.
Mr. Chairman, I want to start off by asking unanimous
consent to place in the record an article that appeared in
today's New York Times, if I might.
Senator Inhofe. Without objection, so ordered.
[The referenced material was not submitted in time for
print.]
Senator Boxer. Unions say EPA bends to political pressure.
In brief, it says, ``Unions representing thousands of staff
scientists at the EPA say the Agency is bending to political
pressure, ignoring sound science and allowing a group of toxic
chemicals to be used in pesticides.'' It goes on, they say the
chemicals pose serious risks for fetuses, pregnant women, young
children. These are scientists who don't agree with Ms.
Charnley, I don't think.
And it goes on to say, ``The complaints from Agency
employees are the latest to come from within Federal agencies
that accuse the Bush administration of allowing politics or
industry pressure to trump science on issues like climate
change and stem cell research.'' ``More and more, the unions
are coming together to confront the Agency's unwillingness to
make the appropriate use of science to show risk to public
health and the environment,'' said a senior scientist, William
Herzy.
And it goes on to say, ``You go to a meeting, where it
comes down, this is an important chemical, this one we have got
to save. It is all informal, of course, but it suggest that
industry interests are governing the decisions of EPA.''
Anyway, I want to put this in the record, because for all the
talk about how great the chemical companies are, and I am sure
some of them are, they are not all great. I know we are having
trouble just getting the chemical companies to admit that they
ought to do more to protect the American people in the case of
another 9/11. So we have a ways to go.
Ms. Charnley, your testimony kind of shocked me, because I
have been, as Senator Jeffords and Senator Lautenberg, working
with a lot of doctors and scientists on protecting our kids.
And you just painting this real rosy picture. And I guess what
I want to ask you is, do you know what the infant mortality
rate is in America compared to the rest of the developing
world, the developed world, not the developing world, but the
developed world, the industrialized world? Do you know those
numbers?
Ms. Charnley. I don't. We do pretty well, but we are not
the best.
Senator Boxer. No, we are not the best. We are the second
worst. We are the second worst. So for you to come here and say
how healthy kids are, read the facts. You come here and present
yourself as an expert and you don't even know what the infant
morality rate is? I mean, that in itself says to me--I don't
really know, you know, who you work for. So maybe you could--I
know you do some work for EPA, you sit on some of these panels.
But in the course of your work, have you been hired by chemical
companies?
Ms. Charnley. I work for----
Senator Boxer. Industry?
Ms. Charnley. I work for industry, for Government, I do
some teaching and I have some non-profits. I have a mix of
clients.
Senator Boxer. Who are the non-profits?
Ms. Charnley. Environmental Law Institute, one of the
mining organizations.
Senator Boxer. Mining--would you get that to me?
Ms. Charnley. Sure.
Senator Boxer. Thank you. That will be very helpful.
Ms. Charnley. And I am not clear about the comment about
connecting infant mortality rates to chemical exposures.
Senator Boxer. You are?
Ms. Charnley. Has that been done?
Senator Boxer. Well, you just made a statement about our
kids' health that was incorrect. And I am correcting you on
that. You obviously don't see the connection, and I was going
to ask you this. You said it is all about the dose. Would you
agree that some chemicals don't leave the body and they
accumulate, so if you look at one dose, that is not reflective
if in fact the body keeps on building up, such as mercury?
Ms. Charnley. I think that is exactly what I did say, that
looking at one dose is not helpful in terms of evaluating risk,
but looking at----
Senator Boxer. Cumulative?
Ms. Charnley.--over time can be very helpful.
Senator Boxer. So would you say that it is, that some
chemicals are quite harmful if they accumulate in the body?
Would you agree with that?
Ms. Charnley. Only if they accumulate to a dose that is
toxic. And it turns out most of the bioaccumulative chemicals
like dioxin are now present in our bodies at levels 95 percent
less than what they used to be.
Senator Boxer. OK, wait, wait, wait, wait. You would agree
with me that at a certain point, if chemicals keep on
accumulating and there is no end to the fact that they keep
on--at some point they are dangerous, you would agree with
that?
Ms. Charnley. If the toxic dose is reached, they would be.
Senator Boxer. OK, very good. I am glad we have that
agreement, because that is an important point. Because I think
we ought to follow science on what that level is, and not
people who are paid by the industry or mining and non-profit
companies.
Mr. Wilson, I want to welcome you. You are a breath of
fresh air. Is it true you were a fireman before you went into
this line of work?
Mr. Wilson. A firefighter/paramedic, yes.
Senator Boxer. Firefighter/paramedic. So I would like to
talk to you about that. You know, we heard, and if Senator
Clinton were here, I think she would talk about this, when the
first responders came down to 9/11, everything was going to be
just fine. And now we are seeing all kinds of problems.
So I want to ask you just a larger question about the
impact of these chemicals on our workers across the board.
Mr. Wilson. Well, occupational disease, it is an enormous
burden in the United States. We have made estimates in the
report as to the burden of occupational disease that is
directly attributable to chemical exposures in the workplace.
And we have provided an analysis of why those numbers actually
probably underestimate the true effects. And again, it gets
back to the problem that there is a data gap in the market.
There is an under-appreciation of the effects of chemical
exposures that occur in the workplace among workers, among
health care practitioners, physicians. There is a real lack of
occupationally trained physicians in the United States
And I worked, during my doctoral dissertation work, I
worked with automotive mechanics who were using a brake
cleaning solvent to clean engines and brakes and what have you.
We identified a number of them that had developed a
debilitating neurological disease from their exposure to hexane
under uncontrolled conditions. Those individuals went from
being productive workers in our society to being disabled
individuals with the costs of workers comp and disability and
rehabilitation and what have you. We are seeing about 23,000
cases every year in California of deadly chronic disease
attributable to chemical exposures in the workplace. And it is
a serious problem.
Senator Boxer. Well, I just want to thank you for being
here, and I agree with you that TSCA needs an overhaul.
Thank you, Mr. Chairman.
Senator Inhofe. Thank you, Senator Boxer. We have been
joined by Senator Warner. Senator Warner, do you have a
statement to make or a question for this panel?
Senator Warner. No, thank you, Mr. Chairman.
Senator Inhofe. All right. Well, first of all, I again
apologize to the members for the inconvenience. However, it did
seem to work out pretty well. Senator Warner, we had an
unfortunate death, there is a funeral that takes place at 11
o'clock that some members of the panel have to attend. Now, the
only thing we would be coming back for would be for opening
statements at 3 o'clock. I would like to ask if that is the
desire of the members, to do that, or do submit those opening
statements for the record.
Senator Boxer. Mr. Chairman, I would like to, I have about
a 4-minute or 2 minute opening statement, if I could make it. I
don't think there is a need to come back. If you could extend
until 5 after 11 o'clock, maybe we can get it done.
Senator Inhofe. No, we wouldn't have to extend until 5
after 11 o'clock, if it is a 4-minute statement, we could
recognize you right now and that would take us right up to
time. If there is no objection on the panel, you are recognized
for 4 minutes.
[Laughter.]
Senator Boxer. You know, Mr. Chairman, your subtlety is so
incredible.
I want to thank you very much for this opportunity to read
my statement. And I will summarize it.
I think what----
Senator Warner. Mr. Chairman, I will be happy to remain, if
that would convenience the Chair, upon your departure, until
the colleague from California has completed her remarks. And as
you vote to leave, may I compliment you and your staff on this
renovated hearing room. This is quite elegant.
[Laughter.]
Senator Inhofe. I think it is, Senator. I also mentioned
that this is Cori's last committee hearing, and we recognized
her for the fine job that she has done in running this show.
And it was very generous of you, if you would do that, I
would appreciate it.
Senator Warner. I would be happy to. I know that it is an
urgent matter and you have to attend to it, and I will be happy
to remain until such time as the good colleague from California
wishes.
Senator Inhofe. Aren't we nice? Thank you.
[Laughter.]
Senator Boxer. We are very nice. And thank you, Senator
Warner. But I would be devastated if Senator Inhofe misses my
statement----
[Laughter.]
Senator Boxer [continuing].--because I know how much impact
I have on his views on the environment.
Senator Inhofe. I look forward to reading it.
[Laughter.]
Senator Boxer. Thank you.
OPENING STATEMENT OF HON. BARBARA BOXER, U.S. SENATOR FROM THE
STATE OF CALIFORNIA
I also want to thank the staff, Cori, is it, who has given
so much to this Committee.
Well, once again we find ourselves conducting the first
oversight hearing in many years on an important public health
statute. We waited 4 years for the Superfund hearing we held in
June, and my understanding is that it has been over a decade
since the last comprehensive Toxic Substances Control Act
hearing.
So Mr. Chairman, I am very concerned about this pattern,
and I believe it has serious consequences for public health.
TSCA was intended to provide a comprehensive framework to
address chemical risks when it was passed 30 years ago.
Clearly, we know that chemicals widely used and accepted at one
time can prove to be terribly hazardous and threaten the most
vulnerable among us because of the issues we have talked about,
the fact that certain chemicals accumulate in the body. The
fact is, after a chemical has been used a long time, we find
out more about it.
Unfortunately, we don't understand these threats until we
have adequate testing. TSCA does not ensure that proper testing
takes place. TSCA was intended to protect the public from
hazards associated with the manufacture, import, processing,
use and disposal of chemicals throughout society. There are
over 82,000 chemicals in the TSCA inventory, including those
used in everyday products, like children's toys or household
paint.
There have been tens of thousands of chemicals added to the
TSCA inventory since TSCA was enacted. Most Americans would
probably be surprised to find out that EPA does not routinely
assess the human health and environmental impacts of new or
existing chemicals. The companies that make these products may
not have adequate safety data either, and so we are left in the
dark, to our peril.
The GAO has issued several reports on this subject and will
testify today, and we missed that, I missed that, but the
health and environmental risks of most chemicals in use today
are not known. In some cases, we have learned about the
potential for serious risks posed by everyday chemicals, and
yet they are still on the market, because we don't have a
strong program in place and there has been a failure to protect
the public.
I have an example right here. A set of children's blocks,
sold for use by babies 9 to 24 months old. These are products
we see every day on the shelves. Similar blocks were tested in
a lab and were found to contain thalates. Animal studies show
developmental and reproductive effects of this chemical.
The European Union has regulated thalate exposure in
children. EPA has not taken similar steps to protect children
and TSCA has proven a weak tool for addressing these concerns.
I don't want my grandchildren and anyone else's grandchildren
or great-grandchildren or children putting this stuff in their
mouth. In Europe, it is regulated. Not here.
I am particularly concerned that TSCA fails to include a
provision that specifically protects the most vulnerable among
us, including children. Other environmental statutes, and for
that I thank this Committee, protect vulnerable populations,
including the Clean Air Act, the Safe Drinking Water Act, and
the Food Quality Protection Act. The Safe Drinking Water Act
happened to be my amendment, but I based it on these other
protections.
I have serious concerns with other weaknesses in TSCA,
including very restrictive confidentiality provisions that
interfere with the public's right to know, their right to know
the risks that we face. You know, we in California, we trust
our people. We tell them what is in a product. You don't like
it. But the fact is, they have a right to know, and I will
fight with every fiber in my body to make sure the public knows
what is in these products.
Let the public vote with their feet. We don't need a law,
Mr. Chairman. We told people about the tuna sandwiches they
were packing for their kids, and we told them that a lot of the
imported tuna, involved in the catching of that tuna was the
killing of dolphins. So we said, we will have a dolphin-safe
label. It was simple. And guess what? People voted with their
feet and they didn't buy that tuna any more, and it had an
impact.
And I think in a free society like this one, freedom of
information is important. Let the public vote. They ought to
know what chemicals are in these products. And it is pretty
simple.
I am proud to be a co-sponsor of the Jeffords&utenberg
Child, Worker and Consumer Safe Chemicals Act. That would be a
positive step in increasing information on chemical risks,
expands enforcement authorities. And I hope today's hearing is
not the first step to close our eyes and not to listen to the
scientists at EPA, but rather to open up our eyes and our ears
and reform TSCA, so that it does the kind of good that people
expect it to do.
I thank you very much, Mr. Chairman.
Senator Warner. Thank you very much.
Senator Jeffords, anything further that you know of?
Senator Jeffords. I thank the Senator for her statement,
and I join her in her statement.
Senator Boxer. Thank you.
Senator Jeffords. I look forward to working with you on
your statement.
Senator Boxer. Thank you very much.
Senator Warner. Senator Jeffords, with your concurrence, we
shall now stand in recess until the call of the Chair.
Senator Jeffords. That is fine with me.
[Whereupon, at 11:03 a.m., the committee was adjourned.]
[Additional statements submitted for the record follow.]
Statement of Hon. James M. Jeffords, U.S. Senator
from the State of Vermont
Chairman Inhofe, thank you for holding this important hearing on
what I think is a fundamental gap in the fabric of our public health
protections.
Recent scientific and medical advances have triggered renewed
concerns about the adequacy of the U.S. chemical management law.
Let me highlight five basic facts that should shape how we reform
the antiquated Toxic Substances Control Act.
First, without question, chemicals play a vital role in enhancing
our quality of life.
Second, compelling new scientific evidence has uncovered widespread
human exposure to industrial chemicals. For example, the U.S. Center
for Disease Control conducted a comprehensive study revealing exposure
to over 100 industrial chemicals in the bodies of ordinary Americans.
Another study found over 200 synthetic chemicals in the umbilical cord
blood of newborn babies.
Third, most of these chemicals have never undergone any Federal
safety review or testing. The mere presence of industrial chemicals in
small quantities in our bodies does not mean that such levels are
dangerous. But after 30 years, shouldn't the EPA have data to tell us
more about the potential dangers?
Fourth, chemical manufacturers generally are not required to
conduct basic health and safety testing before putting their chemicals
into consumer products. A study I requested of the General
Accountability Office found that the EPA has used its authority to
require testing for fewer than 200 of the 62,000 chemicals in commerce
in 1979, when the EPA program began.
Finally, the statute fails to give the EPA adequate authority to
identify, evaluate and respond to dangerous chemicals in a timely
manner.
In 30 years, the EPA has issued regulations to ban or restrict the
use of only five chemicals. The Agency hasn't even initiated such a
rulemaking since 1989. To make matters worse, the EPA's inaction has
occurred in the face of a continuing wave of studies that have found
links between chemical exposure and various diseases.
In my opinion, a fundamental overhaul of the Toxic Substances
Control Act is long overdue.
A sound chemical policy would promote the use of safe chemicals,
and quickly identify and manage those few dangerous chemicals that
cause cancer; neurological or development disabilities; or are
otherwise devastating to human health.
Doctors from the Mount Sinai School of Medicine estimate that the
costs of lead poisoning, asthma, cancer and developmental disabilities
caused by exposure to industrial chemicals is roughly $55 billion
annually. For this reason, I was proud to draft the Kids Safe Chemicals
bill with Senator Lautenberg.
This bill would protect children by requiring chemical
manufacturers to develop basic health and safety data on all chemicals
used in consumer products. It would expand public information so
consumers can make informed choices, encourage the development of safer
alternatives, and give the EPA the tools to take action when needed.
I look forward to today's hearing, and to working in a bipartisan
manner to address this critical public health issue.
__________
Statement of James B. Gulliford Assistant Administrator, Office of
Prevention, Pesticides and Toxic Substances, U.S. Environmental
Protection Agency
introduction
Mr. Chairman and Members of the Committee, thank you for the
invitation to appear before you today. It is my privilege to represent
the U.S. Environmental Protection Agency (EPA) during this oversight
discussion on the Toxic Substances Control Act (TSCA).
key accomplishments
EPA takes very seriously its commitment to implementing TSCA and to
protecting both the American public and our environment from the
adverse effects of chemicals. We are also extremely proud of the many
accomplishments we have achieved in the past 3 decades and the progress
that has been made in protecting human health and the environment.
TSCA provides the Agency with the necessary authority to ensure
that new chemicals are adequately reviewed, that EPA can require
reporting or development of information needed to assess existing
chemicals, and that those chemicals that pose an unreasonable risk can
be effectively controlled. Using TSCA as the foundation for our
efforts, EPA has, over the decades, developed a wide array of
regulatory and voluntary approaches and tools to assist us in our goal
to protect both human health and the environment. Using the strengths
of both regulatory and partnership approaches we have ensured
effective, timely chemical management decisions. We have developed
sophisticated modeling programs which assist both the Agency and
industry in developing, reviewing, and manufacturing safer chemicals.
We have incorporated broad pollution prevention approaches into both
our regulatory work and numerous highly successful voluntary programs
which have considerably increased the speed at which we have been able
to achieve environmental results. We have worked cooperatively with the
regulated community, our stakeholders, our counterparts in other
Federal agencies, States and Tribes, and the public on a broad range of
programs and activities, in order to make informed and transparent
chemical management decisions. We have also worked closely with the
international community on chemical management issues because we
recognize that global coordination and harmonization is critically
important in ensuring a level playing field for all. I would like to
take a few moments to share with you some of the highlights of the
progress and achievements of our TSCA-related activities.
epa's regulatory accomplishments
When TSCA was passed almost 30 years ago, there were 62,000
chemicals on the TSCA Chemical Substance Inventory of existing
chemicals. Since that time, under Section 5 of TSCA (which addresses
new chemical review and control), EPA has reviewed more than 45,000 new
chemical submissions. EPA has regulated more than 1,800 of these new
chemicals. An additional 1,700 have been withdrawn by industry.
Approximately 20,000 chemicals have gone into production and have been
added to the Inventory. The remaining new chemical submissions have
either not gone into production or were the subject of applications for
review as exemptions from Premanufacture Notification (e.g., Low Volume
Exemptions). Voluntary environmental stewardship programs also play a
significant role in our efforts to promote the development of safer and
greener new chemicals, and innovative programs like Sustainable Futures
and the Persistent, Bioaccumulative, and Toxic (PBT) Profiler are key
contributors in this regard,
Under Section 4 of TSCA, EPA has issued test rules or used
Enforceable Consent Agreements to require the generation of testing on
more than 200 chemicals. EPA has also successfully utilized voluntary
stewardship approaches to address existing chemicals. In 1998, EPA,
working cooperatively with the chemical industry and the environmental
community, under the High Production Volume (HPV) Challenge Program,
sought commitments from chemical manufacturers to make basic health and
safety data publicly available on the chemicals produced in the United
States at over a million pounds a year. While annual production volumes
vary substantially over the current Inventory of some 80,000 chemicals,
these approximately 2,800 HPV chemicals account for more than 93
percent of the production volume from the chemicals we track on the
Inventory. This program has also been coordinated with international
testing programs which has resulted in greater participation and has
ensured that U.S. manufacturers not bear the entire burden of
developing this critical data. Under the Bush administration priority
implementation of the HPV Challenge Program has continued and, to date,
more than 370 chemical manufacturers, either individually or as part of
an industry consortia, have stepped forward to sponsor more than 1,400
chemicals under the HPV Challenge, and over 800 chemicals have been
sponsored under the complementary international effort. Data have been
submitted for over 97 percent of HPV Challenge chemicals and the
international effort will continue to contribute information. EPA is
reviewing and assessing the data submitted on approximately 1700 HPV
chemicals to date, to identify chemicals that may warrant additional
follow-up action or assessment.
This past Spring, EPA also made good on its 1998 commitment to make
the HPV data publicly available with its release of the internet-
accessible HPV Information System. Building on this effort, EPA will
co-host a conference this December with NEWMOA, the Northeast Waste
Management Officials' Association, which will provide an opportunity
for a wide range of stakeholders and interested parties to share
experiences in using and accessing the HPV data.
Recognizing the success of the HPV Challenge Program, chemical
industry leaders, through the American Chemistry Council, the Soap and
Detergent Association, and the Synthetic Organic Chemical Manufacturers
Association, came together to extend the HPV program by announcing in
late 2005, their intention to develop these health and safety data on
an additional 500 HPV chemicals. EPA is very encouraged by this effort
and will work closely with the participants as their effort proceeds.
TSCA also provides the Agency with the authority to address
unreasonable risks through Section 6. To date, the agency has regulated
five existing chemicals or chemical categories and four new chemicals
under Section 6.
TSCA, through Section 8 requirements, provides the agency with the
ability to require recordkeeping and reporting on a wide range of data,
including production volume information, health and safety data, and
substantial risk information. For example, more than 50,000 health
effects, environmental effects, and environmental fate studies have
been submitted to the Agency. This information helps not only EPA, but
a number of other Federal Agencies in their efforts to assess
chemicals. EPA also receives industry submissions under TSCA section
8(e), of ``substantial risk'' information which alerts EPA to critical
new test data and which, when appropriate, is referred to other
Agencies, industry, and stakeholder groups.
Section 12 of TSCA ensures that the United State notifies other
countries when certain chemicals are exported. Section 13 prohibits the
import of chemicals that would not be in compliance with TSCA. Section
14 puts in place requirements for handling confidential business
information submitted by companies, and Section 21 sets forth a process
that allows the public to petition the Agency to take action on
specific chemical issues.
voluntary efforts
Recently, a number of voluntary phase-out actions by chemical
companies have been given regulatory effect through the use of TSCA
authority. Several high-profile examples include one company's decision
in May, 2000 to voluntarily cease production by 2002 of 88 ``PFOS''-
related perfluorinated chemicals, which were widely used in many soil
and stain resistant products. EPA, under the Bush administration, took
prompt regulatory action under Section 5 of TSCA by issuing Significant
New Use Rules (SNURs) to ensure that new uses of these chemicals will
be reviewed by the Agency prior to manufacture or re-introduction in
the marketplace. EPA subsequently proposed a SNUR for an additional 183
PFOS-related chemicals which would subject them to the same
requirements. In 2004, following discussions with EPA, another U.S.
chemical company announced its decision to withdraw ``PentaBDE'' and
``OctaBDE,'' polybrominated diphenyl ether (PBDE) flame retardants used
in furniture foam and other products, from production by the end of
2004. The Agency also followed up this voluntary action with a SNUR
that will ensure that new uses of these chemicals are reviewed by the
Agency prior to introduction into the marketplace.
During its work on PFOS, the Agency, through Section 8(e)
reporting, became aware of concerns with a related perfluorinated
chemical, ``PFOA,'' which is used as a processing aid in the production
of a wide range of stick-resistant consumer products. EPA began the
development of a risk assessment and, recognizing we do not currently
have the data necessary to understand the sources and pathways of human
exposure to PFOA, launched a formal process with industry and other
interested parties to develop needed information utilizing specific
testing agreements, including Memoranda of Understanding and TSCA
Section 4 Enforceable Consent Agreements. EPA is thus working to
develop the scientific information needed to fully understand how
people are being exposed to PFOA and what, if any, concerns those
exposures may pose. Industry has responded by initiating new studies,
including through enforceable as well as voluntary testing efforts. EPA
recognized that the science was still coming in but the concern was
there, so EPA Administrator Stephen Johnson asked eight chemical
companies to join the Agency in an environmental stewardship program
that has resulted in the industry committing to a 95 percent reduction
in PFOA emissions and product content by no later than 2010, and to
work toward eliminating PFOA exposure from these sources by no later
than 2015. The effort to gather exposure data will continue in parallel
to the stewardship program. It is clear from the accomplishments I have
just outlined that TSCA provides broad authority to the Agency to
adequately control new and existing chemicals, and the ability to
address emerging chemical issues as they arise. The Agency's recent
efforts on PFOS, PFOA, and PBDEs, provide clear examples demonstrating
this point.
nanotechnology
In addition, we believe TSCA is adequate for addressing issues that
may arise with emerging technologies, such as nanotechnology. The use
of nanotechnology has enormous potential for a wide array of
applications. At this early stage, there are few detailed studies on
the effects of nanomaterials in the body or the environment. However,
based on early results, it is clear that it is not yet possible to make
broad conclusions about which nanomaterials may pose risks. The Agency
is moving expeditiously, but thoughtfully, to ensure appropriate
oversight of this emerging technology, without impeding its
development. TSCA provides the Agency with the regulatory authority
needed to help ensure that this emerging technology is used safely. We
are using our authorities to regulate new chemical substances under
Section 5 of TSCA, which require that all new chemical substances are
submitted to the Agency for review prior to manufacture and
introduction into commerce. We are also considering developing a
stewardship program to increase understanding of both TSCA new and
existing chemical nanomaterials to complement our on-going new chemical
efforts, assemble existing data and information from manufacturers and
processors of these materials, and encourage the development of test
data needed to provide a firm scientific foundation for future work and
regulatory and policy decisions. We believe that this approach will
ensure that the Agency will be positioned to meet our mandate to
protect both the public and the environment from any unreasonable
risks.
tsca oversight
While I appreciate the opportunity to share with you the highlights
of much of our work on TSCA over the past three decades, we recognize
that no statute is perfect. For this reason, we are most appreciative
of the on-going interest of this Committee in TSCA and the work of the
United States Government Accountability Office (GAO) in their recent
reports on chemical regulation under TSCA and chemical regulation in
the United States, Canada and the European Union. It is clear that
there are different statutory approaches to ensure that chemicals are
manufactured and used safely and that the public and the environment
are adequately protected. As I stated at the beginning of my testimony,
I believe that TSCA provides EPA with the statutory tools necessary to
achieve these goals. We are committed to using sound science to make
risk-based decisions, to complementing these actions with successful
collaborative environmental stewardship programs, and to working with
Governments around the world on chemical management programs.
conclusion
The Agency looks forward to continuing to work closely with members
of this committee and your staff, and the GAO on their reviews of TSCA
as we work together to protect human health and the environment. There
are many dedicated engineers, chemists, biologists, toxicologists,
economists, statisticians, attorneys and other civil servants who work
directly on TSCA issues at EPA. They are among the most scientifically
capable and talented staff at EPA and they work extremely hard to
effectively implement the myriad of TSCA related activities that I have
just shared with you. As an organization, they have demonstrated with
the outcomes of their work the benefits of innovation, collaboration
and sound science. I am extremely proud of their achievements and to be
newly associated with them. Again, I thank you for the opportunity to
be here today and to provide you with this information. I am happy to
answer any questions.
______
Responses by James B. Gulliford to Additional Questions
from Senator Inhofe
Question 1. Mr. Guliford, there has been a lot of criticism of
OPPTS' use of models to conduct initial screening of chemicals to
determine adverse effects. I find it very interesting that these same
critics fiercely defend modeling in the Clean Air program or the Clean
Water Program, etc. Can you speak to the nature of your models and the
extent to which they are more likely to overestimate risk than
underestimate it? Has there been any third party review of your models?
Response. Our experience has shown that EPA's model, is an
important and effective tool for screening out potentially hazardous
chemicals. My Office (the Office of Prevention, Pesticides and Toxic
Substances) has worked over the past 25 years to verify and improve its
modeling tools. EPA has guidance and policy, such as the Peer Review
Handbook, Information Quality Guidance, as well as draft guidance
developed by the EPA Council on Regulatory Environmental Modeling,
which addresses the development, validation, and use of models in a
planned and systematic process. We have subjected many such tools and
models to independent third party peer review (e.g., Science Advisory
Board). In addition, EPA has worked, and is continuing to work with the
European Union and the Organization for Economic Cooperation and
Development (OECD) to verify and validate both qualitative (SAR) and
quantitative (QSAR) Structure-Activity Relationship models (designated
together as (Q)SARs).EPA uses data that it receives through new
chemical notices, test data submissions, and other sources, like the
High Production Volume Challenge Program, to support its assessments
and to improve the capabilities of its predictive tools, such as (Q)SAR
modeling. We also have models that predict human and environmental
exposures.
Overall, EPA is confident that the assumptions and inputs used in
its models result- in risk estimates that are protective of human
health and the environment. Verification studies and peer reviews
support this statement. In addition, the general lack of substantial
risk reports under section 8(e) of the Toxic Substances Control Act
(TSCA). which are indicative of errors in our new chemical assessments.
further demonstrates the accuracy and quality of our initial assessment
tools.
Question 2. Mr. Gulliford, we have heard a lot about how companies
have not ``sponsored'' all 11PV chemicals on the list. Didn't you just
finalize a Section 4 test rule covering some of the HPV chemicals that
did not have sponsors? Do you plan to issue more of those rules?
Response. EPA issued a test rule for 17 HPV unsponsored chemicals
under section 4 of TSCA on March 16, 2006. We are working on a second
HPV test rule scheduled to be issued by September 2007 to ensure that
this level of test data is available for additional HPV chemicals.
EPA has also used another TSCA reporting mechanism to gather
information on unsponsored 1-IPV chemicals. On August 16, 2006, EPA
published two final information- gathering rules under section 8(a) of
TSCA. The Preliminary Assessment Information Reporting (PAIR) rule,
issued under TSCA section 8(a), requires manufacturers of 243
unsponsored HPV chemicals to submit a report on general production or
importation volume, end use, and exposure-related information that is
readily obtainable. The Health and Safety Data Reporting rule, issued
under TSCA section 8(d), requires manufacturers of the same 243
chemicals to submit unpublished health and safety data to EPA. The
information required by these rules will be used to support additional
section 4 rulemakings, as appropriate.
______
Response by James B. Gulliford to Additional an Questions
from Senator Jeffords
Question 1. Mr. Gulliford, nanotechnology has tremendous promise in
the fields of health and environmental cleanup. TSCA has been
criticized as being too burdensome to provide the safety assurances to
promote this technology in a safe manner. What steps are you taking to
make sure that EPA can safely and expeditiously evaluate these emerging
technologies?
Response. EPA recognizes the promise of nanotechnology and is
moving expeditiously, but thoughtfully, to ensure the appropriate
review of nanoscale materials, while not impeding the development of
this technology. The Agency's current authority to regulate new and
existing chemical substances under TSCA extends to nanoscale materials,
and we have reviewed, and continue to review, new chemical nanoscale
materials.
EPA is working in an open and transparent process to further
develop a framework to appropriately address nanoscale materials. We
are also considering establishing a stewardship program with
stakeholder input to increase our understanding of both TSCA new and
existing chemical nanoscale materials to complement our on-going
efforts. We believe this approach will ensure that the Agency will be
positioned to meet our mandate to protect both public health and the
environment from unreasonable risks. EPA is active in the National
Nanotechnology Initiative (NNI) through membership in the Nanoscale
Science, Engineering and Technology (NSET) subcommittee of the
Committee on Technology (CT) of the President's National Science and
Technology Council (NSTC). Through participation in NSET, several of
its workgroups, and direct interactions with other Federal Agencies. we
have leveraged our research funds as well as increased our ability to
assess nanoscale materials.
______
Responses by James B. Gulliford to Additional Questions
from Senator Boxer
Inadequacy of Voluntary Children's Chemical Evaluation Program
Question 1. Assistant Administrator Gulliford. the Voluntary
Children's Chemical Evaluation Program is an EPA pilot program to let
industry voluntary provide needed safety data on chemicals.
On June 30, 2006, the EPA's Children's Health Protection Advisory
Committee wrote a letter to EPA saying that the Committee had ``strong
concerns with [the program's] structure and implementation.''
The primary goal of the program is to ensure publicly available
data on the risks to children's health from toxic chemicals. The
Children's Committee said that the ``program, as implemented, however,
is not on track to fulfilling its stated goal.'' The committee
discussed problems with the lack of an adequate peer review process,
industry selection of the reviewers and industry production of key
documents without EPA oversight.
Is EPA going to implement all of the Children Committee's
recommendations?
Please provide me with information on EPA's schedule for
implementing these recommendations by August 18, 2006, and regular
updates thereafter on EPA's progress.
To the extent that you do not plan to implement any of these
recommendations, please explain why you do not plan to implement such
recommendations.
Response. Per your request above, the information and response to
this question was provided to your staff on August 18, 2006.
lead exposure reduction regulations
Question 2. Assistant Administrator Gulli ford, Congress amended
TSCA in 1992 by adding Title IV, which required EPA to create a series
of regulations that protect the public from lead exposures. Lead is a
very toxic metal that harms the nervous system, especially of children.
How many of the actions described in Title IV has EPA failed to
complete? Please list each action, its corresponding statutory
provision, any relevant statutory deadline, the status of EPA's
activities responding to Congressional direction, the date that EPA
expects to complete the required action, and the health effects caused
by the types of exposures to lead that Congress directed EPA to reduce,
including the number of children potentially affected by such
exposures.
Response.Through EPA's coordinated efforts with other Federal
Agencies (HUD, CDC) there has been substantial progress over the years
in reducing harmful exposures to lead in children. Over the period of
1976-2002, the percentage of children, ages of 1-5, with elevated blood
lead levels has declined steeply from 77 percent to 1.6 percent with
310,000 children having elevated blood lead levels.
EPA's efforts since the inception of the lead program pursuant to
the Residential Lead-Based Paint Hazard Reduction Act of 1992 (TSCA
Title IV) have contributed to more recent improvements which show that
since the period 1991-1994 the percentage of children between the ages
of 1-5 with elevated blood lead levels have declined from 4.4 percent
to 1.6 percent or 310,000 children as of the latest CDC reporting
period, 1999-2002. EPA is committed to continuing to support the
Administration's goal of eliminating childhood lead poisoning as a
major public health concern by the year 2010.
Health effects associated with exposure to inorganic lead and
compounds include, but arc not limited to, neurotoxicity, developmental
delays, hypertension, impaired hearing acuity, impaired hemoglobin
synthesis, and male reproductive impairment. Importantly, many of
lead's health effects may occur without overt signs of toxicity. Lead
has particularly significant effects in children, well before the usual
tenn of chronic exposure can take place. Children under 6 years old
have a high risk of exposure because of their more frequent hand-to-
mouth behavior (Centers for Disease Control and Prevention (CDC), 1991:
http://www.cdc.eovincehtleadipublications;booksiplpycicontents.htm).
EPA's actions pursuant to Title IV have contributed to mitigating
harmful exposure to lead. These include targeted outreach and extensive
education activities, as well as regulatory actions.
outreach and education
The Agency's outreach and education efforts began in 1992 and
continue today. These efforts greatly contribute to the increase in
awareness of the hazards of lead generally and the steps the public can
take to protect themselves and their families from lead-based paint
hazards specifically. Actions include:
Ensuring that information about known lead-based paint or lead-
based paint hazards is disclosed to individuals buying or renting pre-
1978 housing. (TSCA Section 1018).
Operating the National Lead Information Clearinghouse (with
additional support from HUD and CDC), which provides the general public
and professionals with information about lead hazards and their
prevention. (TSCA Section 405).
Ensuring that information about lead-based paint hazards is
provided to owners and occupants of pre-1978 housing before renovation
activities take place. (TSCA Section 406).
abatement
EPA has undertaken a range of actions to ensure the abatement of
lead hazards are conducted safely, including rulemaking:
On August 29, 1996, the Agency promulgated regulations for the
abatement of lead for target housing and for child-occupied facilities,
a subset of commercial and public buildings. (TSCA 402(a) and (h)).
On August 29, 1996 EPA promulgated a model State program that
could be used by a State to administer and enforce a State lead-based
paint program at least as protective as the Federal program associated
with section 402. Currently 39 states, the District of Columbia, and
three Native American Tribes arc authorized by EPA to conduct their own
programs. (TSCA Section 404).
On January 2, 2001, the Agency issued regulations that identify
lead-based paint hazards, lead-contaminated dust, and lead-contaminated
soil. (TSCA Section 403).
renovation and remodeling
EPA is currently in the midst of a rulemaking to mitigate risks
posed by lead dust in renovation and repair and painting activities.
Work to support this effort began in 1996; it has been informed by the
development of the regulations noted above that identify lead-based
paint hazards issued in 2001, and most recently a proposal was
published in 2006.
On March 6, 1996, working with HUD, EPA issued a rule containing
lead disclosure requirements for sales and leases of older housing.
(TSCA Section 1018).
In September 1997, the Agency issued renovation guidelines in
residential housing. (TSCA Section 402(c)(l)).
On June 1, 1998, EPA promulgated a regulation that requires each
person who performs for compensation a renovation of target housing to
provide a lead hazard information pamphlet to the owner and occupant of
such housing prior to commencing the renovation. (TSCA Section 406).
In January 2000, EPA conducted a study of renovation and lead
hazards in residential housing. (TSCA Section 402(c)(2)).
In January 2006, EPA issued a proposal to mitigate the risks
posed by renovation, repair and painting activities in housing where
children reside. The proposal includes requirements for work place
standards and for the training of renovators, for renovations in
residential housing with lead-based paint. When finalized, this nile,
coupled with outreach and education efforts, will target Agency
resources toward a comprehensive program that mitigates risks
associated with renovation, repair and painting activities. (TSCA
Section 402 (c)).
In carrying out the statutory provisions we have and continue to
focus our efforts where opportunities for the most meaningful risk
reduction exists.
Question 3. Need for Strong State Programs Assistant Administrator
Oulli ford. States are stepping up to the plate to protect the public
from dangerous chemicals. California's proposition 65 requires consumer
information when products contain substances known to cause cancer or
birth defects. Massachusetts requires facilities to undertake pollution
prevention plans were practical. At least eight States, including
California, have enacted laws restricting the use or production of
brominated flame retardants, which some studies have shown to have
similar threats as DDT and PCBs.
Do you agree that States need to and in fact should protect their
citizens, especially children and other vulnerable individuals, from
dangerous exposures to toxic chemicals?
Response. Yes, all levels of Government--local, State, and
Federal--should work together and have the ability to protect their
citizens, including children and other vulnerable individuals.
epa resources devoted to implementating tsca's protections
Question 4. Assistant Administrator Gulliford, provide a spread
sheet that describes from fiscal year 2001 to 2006 the amount of money
(adjusted to 2005 dollars) on an annual basis that EPA has obligated
and the number of employees, in Federal-Time Equivalents, that EPA has
designated to work on actions under TSCA:
1) Section 5, which authorizes EPA to evaluate submitted
information to determine if action is needed to prohibit or limit
manufacturing, processing, or the intended use of a chemical;
2) Section 4, which authorizes EPA to require manufacturers and
processors to conduct tests to determine if a chemical presents an
unreasonable risk of injury to health or the environment, or if it is
produced in substantial quantities and the potential for release or
human exposure is substantial; and
3) Section 6, which provides EPA with the authority to prohibit or
limit the manufacture. import, processing, distribution in commerce,
use or disposal of an existing chemical.
Exclude all money and FTEs used to support voluntary initiatives,
such as the High Production Volume initiative, from these figures.
Response. EPA is committed to protecting both the American public
and the environment in which we live from the adverse effects of
chemicals. The Agency has successfully integrated a wide array of
regulatory and voluntary approaches to assist us in reaching these
goals. Using the strengths of both regulatory and partnership
approaches, we have ensured a comprehensive program that allows us to
make timely and effective chemical management decisions. These
approaches focus on generating needed test data, assessing the data,
and, when appropriate, taking the necessary steps to reduce the health
and environmental risks of new chemicals--principally a regulatory
activity--and chemicals already in commerce--where we utilize both
regulatory and voluntary activities.
For example. the Agency developed a comprehensive program for
addressing High Production Volume (HPV) chemicals that includes:
a Challenge program to industry, which started in 1998, to
voluntarily make basic health and safety data publicly available,
regulatory backstops, under Section 4 of TSCA, that will ensure
that HPV Chemicals are adequately tested; and, under Section 8(a) and
(d), that requires reporting that will allow the Agency to make the
Section 4 statutory findings on 1-IPV chemicals not sponsored in the
Challenge program,
an information management system, the High Production Volume
Information System, or HPVIS, that is making the information accessible
and useable for EPA, other Federal and State Agencies, and the public,
and, finally, required reporting of exposure and use information
under the IUR amendments that will allow risk-based assessments of all
HPV chemicals.
This type of broad, integrated approach to addressing potential
chemical risks is critical to ensuring that the Agency has the
information it needs to effectively assess and manage these risks.
The Agency has also successfully incorporated broad pollution
prevention approaches into both our regulatory and voluntary programs,
which have considerably increased the speed in which we have been able
to achieve environmental results. This vital integration of regulatory,
voluntary, and prevention approaches have also helped encourage the
introduction of safer and greener new chemicals.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
Question 5. Assistant Administrator Gulliford, provide a spread
sheet that describes from fiscal year 2001 to 2006 the amount of money
(adjusted to 2005 dollars) on an annual basis that EPA has obligated
and the number of employees. in Federal-time Equivalents, that EPA has
designated to work on voluntary initiatives concerning chemical testing
and exposures, including but not limited to the High Production Volume
Initiative and the Voluntary Children's Chemical Evaluation Program.
Response. EPA is committed to protecting both the American public
and the environment in which we live from the adverse effects of
chemicals. The Agency has successfully integrated a wide array of
regulatory and voluntary approaches to assist us in reaching these
goals. Using the strengths of both regulatory and partnership
approaches, we have ensured a comprehensive program that allows us to
make timely and effective chemical management decisions. These
approaches focus on generating needed test data, assessing the data,
and, when appropriate, taking the necessary steps to reduce the health
and environmental risks of new chemicals--principally a regulatory
activity--and chemicals already in commerce--where we utilize both
regulatory and voluntary activities.
For example. the Agency developed a comprehensive program for
addressing High Production Volume (HPV) chemicals that includes:
a Challenge program to industry, which started in 1998, to
voluntarily make basic health and safety data publicly available,
regulatory backstops, under Section 4 of TSCA, that will ensure
that HPV Chemicals are adequately tested; and, under Section 8(a) and
(d), that requires reporting that will allow the Agency to make the
Section 4 statutory findings on 1-IPV chemicals not sponsored in the
Challenge program,
an information management system, the High Production Volume
Information System, or HPVIS, that is making the information accessible
and useable for EPA, other Federal and State Agencies, and the public,
and, finally, required reporting of exposure and use information
under the IUR amendments that will allow risk-based assessments of all
HPV chemicals.
This type of broad, integrated approach to addressing potential
chemical risks is critical to ensuring that the Agency has the
information it needs to effectively assess and manage these risks.
The Agency has also successfully incorporated broad pollution
prevention approaches into both our regulatory and voluntary programs,
which have considerably increased the speed in which we have been able
to achieve environmental results. This vital integration of regulatory,
voluntary, and prevention approaches have also helped encourage the
introduction of safer and greener new chemicals.
CHART
Children's Toys and Dangerous Chemicals
Question 6. Assistant Administrator Gulliford, provide all requests
for information that the EPA has sent to the manufacturers of
children's toys sold in the United States and chemical manufacturers or
processors that produce chemicals used to make children's toys sold in
the United States, where the Agency asked for information on the
toxicity of chemicals used in the toys, levels of potential exposure to
those chemicals, and the potential health effects related to children
playing with such toys.
Response. EPA takes very seriously its commitment to protect
children's health, and TSCA provides authority to protect children from
unreasonable risks from chemical substances, mixtures, and articles,
including toy products. EPA collects information on chemicals
manufactured or imported in the United States and listed on the TSCA
Chemical Substances Inventory. These chemicals may be used in a variety
of processes and products. EPA recognized the need for additional
reporting of processing and use information, including the use of
subject substances in consumer products and in products intended for
use by children. In 2003, EPA amended the Inventory Update Reporting
(1UR) requirements to ensure that the data collected more closely match
EPA's information needs. The inclusion of the children's use category
in the IUR will provide the Agency and others with specific reporting
of the chemicals used in products intended for use by children. The
first industry reporting of this information must be completed by
December 2006. EPA will use this data to further its understanding of
uses potentially affecting children and whether any follow-up actions
may he needed.
To further understand and address hazards and exposures associated
with chemicals, including children's exposures, EPA works with the U.S.
Consumer Product Safety Commission (CPSC) and other Agencies as
appropriate on issues regarding consumer products, including those
intended for children.
In addition, in response to a recent TSCA section 21 citizen's
petition regarding lead in toy jewelry, EPA published a notice in the
Federal Register (71 ER 30921 (May 31, 2006)) requesting information on
the presence of lead in toy jewelry and on the health effects.
particularly to children, from toy jewelry or similar objects
containing lead.
Children's Toys and Dangerous Chemicals
Question 7. Assistant Administrator Gulliford, provide a list of
the chemicals used in toys sold in the 1 United States, including
whether each chemical is known or suspected of causing cancer,
developmental effects or birth defects.
Response. The Agency takes very seriously its commitment to protect
children's health, and TSCA provides authority to protect children from
unreasonable risks from chemical substances, mixtures, and articles to
which children may be exposed. including toys. To further enhance our
understanding of children's exposures to chemical, EPA has several
efforts underway to develop information on products and chemicals to
which children may be exposed.
EPA collects information on chemicals manufactured or imported in
the United States and listed on the TSCA Chemical Substances Inventory.
These chemicals may be used in a variety of processes and products. In
2003. EPA amended the Inventory Update Reporting requirements to ensure
that the data collected more closely match EPA's information needs.
Specifically, EPA recognized the need for additional reporting of
processing and use information, including the use of subject substances
in consumer products and in products intended for use by children. The
inclusion of the children's use category will provide the Agency and
others with specific reporting of the chemicals used in products
intended for use by children. The first industry reporting of this
information must be completed by December 2006. EPA will use this data
to further its understanding of uses potentially affecting children and
whether any follow-up actions may be needed.
In addition, under EPA's Voluntary Children's Chemical Evaluation
Program (VCCEP), developed after extensive stakeholder dialogue, EPA
launched a pilot program to provide data to enable the public to
understand the potential health risks to children associated with
certain chemicals. Under the pilot, EPA asked companies which
manufacture and/or import 23 chemicals that have been found in human
tissues and the environment in various monitoring programs to volunteer
to sponsor the evaluation under VCCEP. Thirty-five companies and ten
consortia responded and volunteered to sponsor 20 chemicals.
To further understand and address hazards and exposures associated
with chemicals, including children's exposures, EPA works with the U.S.
Consumer Product Safety Commission (CPSC) and other Agencies as
appropriate on issues regarding consumer products, including those
intended for children.
Cosmetics and Dangerous Chemicals
Question 8. Assistant Administrator Gulliford, provide all requests
for information that the EPA has sent to the manufacturers of cosmetics
sold in the United States and chemical manufacturers or processors that
produce chemicals used to make cosmetics sold in the United States,
where the Agency asked for information on the toxicity of chemicals
used in the products, levels of potential exposure to those chemicals,
and the potential health effects related to applying these cosmetics.
Response. ``Cosmetics'' as defined under the Federal Food. Drug and
Cosmetics Act (12FDCA) arc excluded from the TSCA definition of
``chemical substance and are regulated by the Food and Drug
Administration. (TSCA section 3(2)(B)(vi)). Therefore, EPA has not
issued any information requests relating to cosmetics or substances
when intended for use as a component of cosmetics covered by the FFDCA.
Cosmetics and Dangerous Chemicals
Question 9. Assistant Administrator Wilford, provide a list of the
chemicals used in cosmetics sold in the United States, including
whether each chemical is known or suspected or causing cancer.
developmental effects or birth defects.
Response. Cosmetics arc regulated under the Federal Food. Drug and
Cosmetics Act by the Food and Drug Administration and are excluded from
regulation under TSCA. Therefore, EPA does not maintain a list of
chemicals used in cosmetics sold in the United States.
______
Responses by James B. Gulliford to Additional Questions
from Senator Clinton
Question 1. We know that the Food and Drug Administration is
working to establish information sharing agreements with its regulatory
counterparts in Europe, so as to better coordinate information about
action taken to protect consumers from unsafe drugs or biologics, and.
in this age of globalization, I believe we need to see similar
agreements between the EPA and environmental agencies around the world.
The European Union is currently implementing a program through
which chemical companies are required to submit basic test data on new
chemicals--an authority that does not exist under TSCA. Instead, your
agency relies on models that estimate the impact of new chemicals based
upon what we know about already-existing chemicals with similar
molecular structures.
It would seem to make sense--and this is something that chemical
companies, according to the GAO Report, support--to set up mechanisms
through which the data collected by the EU is shared with the EPA. That
way. regulatory decisions about new chemicals could be based on actual
test data, rather than models.
At the time the GAO report was released in 2005, your agency did
not have a strategy to obtain such data. Since your testimony noted
that the EPA does not require any additional regulatory authority that
might be conferred by Congress, do I understand correctly that the EPA
is currently able to engage in efforts to increase information sharing
with other Governments? What steps have you taken to develop a
mechanism through which to share this data? By what date will you
establish such a system?
Response. EPA is a leader in international information sharing and
is actively engaged in a variety of associated activities. For example,
EPA and the European Commission are collaborating with other member
countries of the Organization for Economic Cooperation and Development
(OECD) in the development of a Global Data Portal. which is intended to
ensure that test data available to the United States the EU, and other
Governments can be shared and accessed. This portal will allow
searching, viewing and exchange of test data between EPA's HPV
Information System (HPVIS) and the test data collected by the EU, as
well as similar data from other countries. As another example EPA will
participate in the development of an EU REACH Implementation Project
specifically designed to develop guidance on grouping chemicals For
assessment. Also, EPA worked closely with the Canadian Government as
they implemented the Canadian Environmental Protection Act (CEPA)
``categorization'' work. That product, when released, will be useful to
U.S. chemicals assessment work in that it will provide assessments of
thousands of chemicals, many of which are on the TSCA Inventory. We
believe this development may provide additional opportunities to
collaborate directly on High Production Volume and lower volume
chemical issues.
As conveyed in EPA's July 31, 2006 response to GAO's report.
Chemical Regulation: Options Exist to Improve EPA's Ability to Assess
Health Risks and Manage Its Chemical Review Program (GAO-05-458). the
Agency has concerns regarding a regulatory approach to collecting the
same data that companies are required to submit to the EU. The
recommendation referenced in the 2005 GAO report suggests a potentially
broad-ranging information collection rule under section 8 of TSCA.
While such a reporting rule may result in the provision of some useful
information, EPA supports more targeted approaches that are directed at
U.S. domestic priorities rather than foreign Government mandates. As
appropriate, EPA will evaluate and implement different approaches to
collect information to address information needs, taking into account
information that will he available through HPVIS, the Global Portal,
and other mechanisms.
Question 2. More than 50,000 health effects, environmental effects,
and environmental fate studies have been submitted to the EPA, and you
note that these studies have helped both your agency and other Federal
agencies assess chemicals and potential exposure risks.
How has the data collected through FSCA been used to improve or
enhance both the CDC's and EPA's biomonitoring efforts? For example, if
a chemical is noted as requiring further study. do you utilize the
tools and expertise in your biomonitoring programs to develop and carry
out tests to assess human exposures?
Response. EPA receives exposure and effects information through a
variety of TSCA authorities and programs. Rather than establishing a
separate biomonitoring effort under TSCA, EPA works through the
established CD(' process (http://www.cdc.gov/exposurereport/) to
nominate chemicals for inclusion in the National Health and Nutrition
Examination Survey (NHANES) biomonitoring efforts where EPA believes
data obtained from biomonitorine, studies would help us to understand
potential population risks.
For example, EPA recently nominated. and CDC accepted. several
chemicals, such as certain perfluorinated compounds (PFOS, PFOA, etc.)
and certain polybrominated diphenyl ethers (PBDEs). among others, to be
added to the National Biomonitoring Program. The first results will be
reported in CDC's Fourth National Report on Human Exposure to
Environmental Chemicals, which will be released next year (summer
2007).
__________
Statement of John B. Stephenson, Director, Natural Resources and
Environment, U.S. Government Accountability Office
Mr. Chairman and members of the committee, I am pleased to appear
today before the Senate Committee on Environment and Public Works, to
discuss our work on the Environmental Protection Agency's (EPA)
implementation of the Toxic Substances Control Act (TSCA). Tens of
thousands of chemicals are currently in commercial use in the United
States and, on average, over 700 new chemicals are introduced into
commerce each year. Although these chemicals are an integral component
in the production of important goods and services, some may be toxic
and may adversely affect human health and/or the environment. It was in
this context, that the Congress passed TSCA in 1976, authorizing EPA to
obtain manufacturer information on the risks of chemicals and to
control those that EPA determines will pose an unreasonable risk.
TSCA addresses those chemicals manufactured, imported, processed,
distributed in commerce, used, or disposed of in the United States, but
excludes certain substances including pesticides regulated under the
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and food
additives, drugs, and cosmetics regulated under the Federal Food, Drug,
and Cosmetic Act (FFDCA). TSCA authorizes EPA to review those chemicals
already in commerce--what are referred to as existing chemicals--and to
assess chemicals before they enter commerce so-called new chemicals.
EPA lists chemicals currently in commerce in the TSCA inventory. Of the
over 82,000 chemicals currently in the TSCA inventory, about 62,000
were already in commerce when EPA began reviewing chemicals in 1979.
Since then, approximately 20,000 new chemicals were added to the
inventory and are now in use as existing chemicals.
Prior to the passage of TSCA, chemical substances generally entered
the marketplace without review or controls. Without Government
intervention, and often with little or no knowledge of their potential
adverse health and environmental impacts, some of these chemicals were
produced and used in high volumes. Earlier legislation on clean water
and air had primarily addressed releases of chemicals into the
environment. In contrast, TSCA authorized EPA to control the entire
life cycle of chemicals from their production and distribution to their
use and disposal--including options for the outright banning of
chemical substances to mandating requirements for chemical testing or
product labeling. Now, chemical companies are required to submit to
EPA, 90 days before beginning to manufacture a new chemical, a
premanufacture notice containing information including the chemical's
identity, categories of uses, estimated production volumes, and any
test data possessed by the chemical company.
My testimony today, which is based on our June 2005 report,
Chemical Regulation: Options Exist to Improve EPA's Ability to Assess
Health Risks and Manage Its Chemical Review Program,\1\ describes EPA's
efforts to (1) assess existing chemicals used in commerce, (2) control
the risks of new chemicals not yet in commerce, and (3) publicly
disclose information provided by chemical companies under TSCA.
---------------------------------------------------------------------------
\1\ 1AGAO, Chemical Regulation: Options Exist to Improve EPA's
Ability to Assess Health Risks and
---------------------------------------------------------------------------
In summary, EPA does not routinely assess the human health and
environmental risks of existing chemicals and faces challenges in
obtaining the information necessary to do so. TSCA's authorities for
collecting data on existing chemicals do not facilitate EPA's review
process because they generally place the costly and time-consuming
burden of obtaining data on EPA, rather than requiring chemical
companies to develop and submit such data to EPA. Consequently, EPA has
used its authorities to require testing for fewer than 200 of the
62,000 chemicals in commerce when EPA began reviewing chemicals under
TSCA in 1979. Recognizing the need for additional information on
existing chemicals, in the late 1990s EPA implemented its High
Production Volume (HPV) Challenge Program, under which chemical
companies have begun to voluntarily provide test data on about 2,800
chemicals produced or imported in amounts of 1 million pounds or more a
year. While the HPV Challenge Program is a laudable effort to develop
data on these chemicals, several problems remain, including that the
chemical industry has not agreed to provide testing for over 200
chemicals originally identified in the HPV Challenge Program and that
even with the test data provided under the program, EPA would need to
demonstrate that the chemicals pose unreasonable risks in order to
control their production or use under TSCA. While TSCA does not define
what risk is unreasonable, according to EPA officials the standard has
been difficult to meet. In order to withstand judicial scrutiny, a TSCA
rule must be supported by substantial evidence in the rulemaking
record. In this regard, EPA officials say the act's legal standards are
so high that they have generally discouraged EPA from using its
authorities to ban or restrict the manufacture or use of chemicals.
Since Congress enacted TSCA in 1976, EPA has issued regulations under
the act to ban or limit the production of only five existing chemicals
or groups of chemicals.
EPA's reviews of new chemicals can provide only limited assurance
that health and environmental risks are identified before the chemicals
enter commerce because TSCA does not require chemical companies to test
new chemicals before notifying EPA of their intent to manufacture a
chemical. Furthermore, chemical companies generally do not voluntarily
perform such testing. Because of a general lack of data, EPA has
developed sophisticated methods to predict the potential exposure and
toxicity levels of new chemicals by using scientific models to compare
them with chemicals with similar molecular structures for which
toxicity information is available. However, the use of these models can
present weaknesses in the assessment because the models are not always
accurate in predicting physical chemical properties and the evaluation
of general health effects is contingent on the availability of
information on chemicals with similar molecular structures.
Additionally, chemical company estimates of a chemical's production
volume and anticipated uses provided in the premanufacture notices that
EPA uses to assess exposure, can change substantially after EPA
completes its review and manufacturing begins. However, these estimates
do not have to be amended by companies unless EPA promulgates a rule
determining that a use of a chemical constitutes a significant new use,
which EPA has done for only a small percentage of new chemicals.
Despite limitations in the information available on new chemicals,
EPA's reviews have resulted in some action being taken to reduce the
risks of over 3,600 new chemicals submitted for review.
EPA's ability to provide the public with information on chemical
production and risk has also been hindered by strict confidential
business information provisions of TSCA. TSCA generally prohibits the
disclosure of confidential business information and, according to EPA
officials, about 95 percent of the premanufacture notices for new
chemicals contain some information that is claimed as confidential.
While EPA has the authority to evaluate the appropriateness of
confidentiality claims, these efforts are time and resource- intensive,
and the agency does not have the resources to challenge a significant
number of claims. State environmental agencies and others have
expressed interest in obtaining information claimed as confidential
business information for use in various activities, such as developing
contingency plans to alert emergency response personnel to the presence
of highly toxic substances at manufacturing facilities. Chemical
companies recently have expressed interest in working with EPA to
identify ways to enable other organizations to use the information
given the adoption of appropriate safeguards.
In our June 2005 report, we recommended that the Congress consider
providing EPA additional authorities under TSCA to improve its ability
to assess chemical risks, such as providing the EPA Administrator the
authority to require chemical companies develop test data when
production volumes reach certain levels. We also recommended that the
EPA Administrator take several actions to improve EPA's management of
its chemical program, including revising its regulations to require
that companies reassert confidentiality claims under TSCA within a
certain time period after the information is initially claimed as
confidential. EPA did not disagree with the report's findings and is in
the process of implementing several of our recommendations. For
example, EPA is currently launching a pilot project to review claims of
confidentiality for data on certain older chemicals.
epa has limited information on the health and environmental risks of
existing chemicals and has issued few regulations controlling such
chemicals
Because chemical companies are generally not required to develop
and submit toxicity information to EPA, when the agency decides to
review existing chemicals, it generally has only limited information on
the risks that the chemicals pose to human health and the environment.
Furthermore, EPA's authority under TSCA to require industry testing
that would provide the information to review the chemicals is difficult
to use, according to EPA officials. EPA has used its authority to
require testing for fewer than 200 of the 62,000 chemicals in commerce
when EPA began reviewing chemicals under TSCA in 1979. Furthermore, EPA
has rarely banned, limited the production, or restricted the use of
existing chemicals. Since 1998, EPA has focused its efforts on
obtaining information on existing chemicals through voluntary programs,
such as the HPV Challenge Program. This program is intended to provide
basic data on the characteristiCs of about 2,800 chemicals produced in
excess of 1 million pounds a year.
EPA Has Limited Toxicity and Exposure Data with Which to
Review Existing Chemicals
EPA's toxicity and exposure data on existing chemicals is often
incomplete and TSCA's authority to require testing in support of the
agency's review process is difficult to use. While TSCA authorizes the
review of existing chemicals, it generally provides no specific
requirement, time frame, or methodology for doing so. Chemical
companies are not required to develop and submit toxicity information
to EPA unless the agency promulgates a testing rule, thus placing the
burden for obtaining data on EPA. In addition, if chemical company
testing shows that a chemical is not toxic, there is generally no
standing requirement that the chemical companies submit this data to
EPA. Consequently, when EPA decides to review existing chemicals, it
generally has only limited information on the risks of injury the
chemicals pose to human health and the environment.
EPA officials told us that in cases where chemical companies do not
voluntarily provide test data and health and safety studies in a
complete and timely manner, requiring the testing of existing chemicals
of concern--those chemicals for which some suspicion of harm exists--is
the only practical way to ensure that the agency obtains the needed
information. For example, there are currently over 200 highproduction-
volume chemicals for which chemical companies have not agreed to
provide the minimal test data that EPA believes are needed to initially
assess their risks. Furthermore, many additional chemicals are likely
to be added to become high production chemicals because the specific
chemicals used in commerce are constantly changing, as are their
production volumes. Chemical industry representatives told us that TSCA
provides EPA with adequate authority to issue rules requiring companies
to provide EPA with any test and exposure data possessed by the
companies, and that EPA could use such authority to obtain company
information on existing chemicals of concern. EPA could then use that
information to determine whether additional rules should be issued to
require companies to perform additional testing of the chemicals.
However, EPA officials told us that it is time-consuming, costly,
and inefficient for the agency to use a two-step process of (1) issuing
rules under TSCA (which can take months or years to develop) to obtain
exposure data or available test data that the chemical industry does
not voluntarily provide to EPA and then (2) issuing additional rules
requiring companies to perform specific tests necessary to ensure the
safety of the chemicals tested. Officials also said that EPA's
authority under TSCA to issue rules requiring chemical companies to
conduct tests on existing chemicals has been difficult to use because
the agency must first make certain findings before it can require
testing. Specifically, TSCA requires EPA to find that current data is
insufficient; testing is necessary; and that either (1) the chemical
may present an unreasonable risk or (2) that the chemical is or will be
produced in substantial quantities and that there is or may be
substantial human or environmental exposure to the chemical.
Once EPA has made the required findings, the agency can issue a
proposed rule for public comment, consider the comments it receives,
and promulgate a final rule ordering chemical testing. EPA officials
told us that finalizing rules can take from 2 to 10 years and require
the expenditure of substantial resources. Given the time and resources
required, the agency has issued rules requiring testing for fewer than
200 chemicals. Because EPA has used authority to issue rules to require
testing so sparingly, it has not continued to maintain information on
the cost of implementing these rules. However, in our October 1994
report on TSCA,\2\ we noted that EPA officials told us that issuing
such a rule can cost hundreds of thousands of dollars.
---------------------------------------------------------------------------
\2\NGAO, Toxic Substances Control Act: Legislative Changes Could
Make the Act More Effective, GAO/RCED-94-103 (Washington, DC: September
26, 1994).
---------------------------------------------------------------------------
Given the difficulties involved in requiring testing, EPA officials
do not believe that TSCA provides an effective means for testing a
large number of existing chemicals. They believe that EPA could review
substantially more chemicals in less time if they had the authority to
require chemical companies to conduct testing and provide test data on
chemicals once they reach a substantial production volume, assuming EPA
had first determined that these data cannot be obtained without
testing. We have long held a similar view based on our reviews
involving TSCA, and in our in June 2005 report, we recommended that the
Congress consider giving EPA the authority to require chemical
manufacturers and processors to develop test data based on substantial
production volume and the necessity for testing.
EPA Has Had Difficulty Proving That Chemicals Pose Unreasonable Risks
and Has Regulated Few Existing Chemicals under TSCA
Even when EPA has toxicity and exposure information on existing
chemicals, the agency stated that it has had difficulty demonstrating
that harmful chemicals pose an unreasonable risk and that they should
be banned or have limits placed on their production or use. Indeed, EPA
has rarely banned, limited the production, or restricted the use of
existing chemicals. Since the Congress enacted TSCA in 1976, EPA has
issued regulations under the act to ban or limit the production or
restrict the use of only five existing chemicals or chemical classes.
For an additional 173 existing chemicals, EPA has required chemical
companies to submit notices of any significant new uses of the
chemical, providing EPA the opportunity to review the risks posed by
the new use.
EPA Implemented a Voluntary Program to Collect More Industry Data on
Existing Chemicals
Facing difficulties obtaining information on existing chemicals,
EPA took steps to address this shortcoming with the implementation of
the HPV Challenge Program in 1998. According to EPA, the lack of
information on existing chemicals and the relative difficulty of
requiring testing under TSCA on the scale that would be necessary for
the thousands of chemicals produced at high volumes, has led EPA, in
cooperation with chemical companies, environmental groups, and other
interested parties, to implement a voluntary program to obtain test
data on highproduction-volume chemicals from chemical companies. The
HPV Challenge Program focuses on obtaining chemical company
``sponsors'' to voluntarily provide data on the approximately 2,800
chemicals that chemical companies reported in 1990, that they produced
at a high volume--generally over 1 million pounds.
Through this program, sponsors develop a minimum set of data on the
chemicals, either by gathering available information, using models to
predict the chemicals' properties, or conducting testing of the
chemicals. EPA plans to use the data collected under the program to
prioritize high-production chemicals for further assessment, but it has
not yet adopted a methodology for prioritizing the chemicals or for
determining those that require additional information. In our June 2005
report, we recommended that EPA develop and implement such a
methodology for using information collected through the HVP Challenge
Program to prioritize chemicals for further review and to identify and
obtain additional information needed to assess their risks. At EPA's
request, a Federal advisory group has proposed a methodology for
prioritizing the HPV Challenge Program chemicals, and EPA anticipates
that the agency will implement the proposal during 2006.
Nonetheless, other problems exist in the HPV Challenge Program.
Chemical companies have not volunteered to provide data on all the
chemicals currently in the HPV Program. In addition, despite the fact
that companies may begin raising the production volumes of other
chemicals, EPA has no mechanism for placing these chemicals on the HPV
Challenge Program list once they are produced in greater volume. We
believe that action to implement our previously mentioned
recommendation that the Congress consider giving EPA additional
authority to require chemical testing could ameliorate such problems.
epa lacks sufficient data to ensure that the potential health and
environmental risks of new chemicals are identified
EPA's review of new chemicals provides only limited assurance that
health and environmental risks are identified because the agency has
limited information with which to review them. In the absence of
chemical test data, EPA largely relies on scientific models that do not
always accurately determine chemicals' properties or the full extent of
their adverse effects. Further, information that companies provide in
the premanufacture notices that EPA uses to assess potential exposures
to new chemicals are estimates that can change substantially once
manufacturing begins. Despite limitations in the information available
on new chemicals, EPA's reviews have resulted in some action being
taken to reduce the risks of over 3,600 new chemicals submitted for
review.
epa has limited information on new chemicals and relies on modeling
tools to assess the health and environmental risks of new chemicals
TSCA generally requires chemical companies to notify EPA of their
intent to manufacture or import new chemicals and to provide any
available test data. Yet EPA estimates that most premanufacture notices
do not include test data of any type, and only about 15 percent include
health or safety test data. Chemical companies do not have an incentive
to conduct these tests because they may take over a year to complete,
and some tests may cost hundreds of thousands of dollars. During a
review of a new chemical, EPA evaluates risks by conducting a chemical
analysis, searching the scientific literature, reviewing agency files
(including files of related chemicals that have already been assessed
by EPA), analyzing toxicity data on structurally similar chemicals,
calculating potential releases of and exposures to the chemical, and
identifying the chemical's potential uses. On the basis of this review,
EPA makes a decision to (1) take no action; (2) require controls on the
use, manufacture, processing, distribution in commerce, or disposal of
the chemical pending development of test data; or (3) ban or otherwise
regulate the chemical pending the receipt and evaluation of test
studies performed by the chemical's manufacturer. Because EPA generally
does not have sufficient data on a chemical's properties and effects
when reviewing a new chemical, EPA uses a method known as structure
activity relationships analysis to screen and evaluate a chemical's
toxicity. This method, also referred to as the nearest analogue
approach, involves using models to compare new chemicals with chemicals
with similar molecular structures for which test data on health and
environmental effects are available.
EPA officials told us that, while the overall accuracy of the
models has not been validated for regulatory purposes, they are
effective as screening tools that allow EPA to focus its attention on
the chemicals of greatest concern--chemicals about which little is
known other than that they are structurally related to known harmful
chemicals. By applying approaches that make conservative predictions,
EPA believes that it is more likely to identify a false positive (where
a chemical is determined to be of concern, but on further analysis is
found to be of low concern) than a false negative (where a chemical is
initially viewed as a low concern though on further analysis is
actually of higher concern). According to EPA, only about 20 percent of
the premanufacture notices received annually go through the Agency's
more detailed full-review process after they have been initially
screened. That is, according to EPA officials, the majority of new
chemicals submitted for review can be screened out as not requiring
further review because (1) EPA determines on the basis of its screening
models that a chemical has low potential to harm human health or the
environment or (2) on the basis of other information, such as the
anticipated uses, exposures, and releases of the chemicals, only
limited potential risks to people and the environment are expected. In
addition, using these models, EPA identifies for possible regulatory
action, those chemicals belonging to certain chemical categories that
based on its prior experience in reviewing new chemicals are likely to
pose potential risks such that testing or controls are needed. In our
June 2005 report, we recommended that the EPA Administrator develop a
strategy for improving and validating, for regulatory purposes, the
models that EPA uses to assess and predict the risks of chemicals and
to inform regulatory decisions on the production, use, and disposal of
the chemicals.
Estimates of Exposures and Other Information Provided in
Premanufacturing Notices Can Change after Manufacturing Begins
EPA bases its exposure estimates for new chemicals on information
contained in premanufacture notices. However, the anticipated
production volume, uses, exposure levels, and release estimates
outlined in these notices generally do not have to be amended once
manufacturing begins. That is, once EPA completes its review and
production begins, chemical companies are not required under TSCA to
limit the production of a chemical or its uses to those specified in
the premanufacture notice or to submit another premanufacture notice if
changes occur. However, the potential risk of injury to human health or
the environment may increase when chemical companies increase
production levels or expand the uses of a chemical. To address this
potential, TSCA authorizes EPA to promulgate a rule specifying that a
particular use of a chemical would be a significant new use. EPA has
infrequently issued such rules, which require manufacturers, importers,
and processors of the chemical for the new use to notify EPA at least
90 days before beginning manufacturing or processing the chemical for
that use.
EPA Reviews of New Chemicals Have Resulted in Some Control Actions
When EPA's assessment of a new chemical identifies health and
safety problems, EPA can issue a proposed rule to prevent chemical
companies from manufacturing or distributing the chemical in commerce,
or to otherwise restrict the chemical's production or use, if the
agency believes the new chemical may present an unreasonable risk
before EPA can regulate the chemical under the relevant provisions of
TSCA. Despite limitations in the information available on new
chemicals, EPA's reviews have resulted in some action being taken to
reduce the risks of over 3,600 new chemicals that chemical companies
have submitted for review. These actions ranged from chemical companies
voluntarily withdrawing their notices of intent to manufacture new
chemicals, chemical companies entering into consent orders with EPA to
produce a chemical under specified conditions, and EPA promulgating
significant new use rules requiring chemical companies to notify EPA of
their intent to manufacture or process a chemical for new uses.
For over 1,700 chemicals, companies withdrew their premanufacture
notices, sometimes after EPA indicated that the agency planned to
initiate the process for placing controls on the chemical, such as
requiring testing or prohibiting the production or certain uses of the
chemical. EPA officials told us that after EPA screens a chemical or
performs a more detailed analysis of it, chemical companies often drop
their plans to market a new chemical when the chemical's niche in the
marketplace is uncertain and EPA requests that the company develop and
submit test data.
For over 1,300 chemicals, EPA has issued orders requiring chemical
companies to implement workplace controls or practices during
manufacturing (pending the development of information), and/or perform
toxicity testing when the chemical's production volumes reached certain
levels. EPA may issue these proposed orders to control the production,
distribution, use, or disposal of a new chemical when there is
insufficient information available to reasonably evaluate the human
health or environmental effects of a chemical and when the chemical (1)
may present an unreasonable risk to human health or the environment or
(2) is or will be produced in substantial quantities and (a) it either
enters or may reasonably be anticipated to enter the environment in
substantial quantities or (b) there is or may be significant or
substantial human exposure to the substance. While TSCA does not
authorize EPA to require that chemical companies develop this
information, the act does allow EPA to control the manufacturing and
processing of the chemical until EPA has sufficient data to determine
if the chemical will pose a risk.
For over 570 new chemicals submitted for review, EPA required
chemical companies to submit premanufacture notices for any significant
new uses of the chemical, providing EPA the opportunity to review the
risks of injury to human health or the environment before new uses had
begun.
epa's ability to share data collected under tsca is limited
EPA's ability to make publicly available the information that it
collects under TSCA is limited. Chemical companies may claim the
information they provide to EPA under TSCA as confidential business
information. While EPA believes that some claims of confidential
business information may be unwarranted, challenging the claims is
resource-intensive.
When companies submit information to EPA through premanufacture
notices, many claim a large portion of the information as confidential.
According to EPA, about 95 percent of premanufacture notices contain
some information that chemical companies claim as confidential. Under
EPA regulations, information that is claimed as confidential shall
generally be treated as such if no statute specifically requires
disclosure. Exceptions include if the information is required to be
released by some other Federal law or court order, if the company
voluntarily withdraws its confidential claim, or if the EPA Office of
General Counsel makes a final administrative determination that the
information does not meet the regulatory criteria substantiating a
legal right to the claim. EPA has not performed any recent studies of
the appropriateness of confidentiality claims, although a 1992 EPA
study indicated that problems with inappropriate claims were extensive.
That study examined the extent to which companies made confidential
business information claims, the validity of the claims, and the impact
of inappropriate claims on the usefulness of TSCA data to the public.
While EPA may suspect that some chemical companies' confidentiality
claims are unwarranted, they have no data on the number of
inappropriate claims.
EPA officials told us that the agency does not have the resources
necessary to investigate and, where appropriate, challenge claims that
it believes are inappropriate. Consequently, EPA focuses on
investigating primarily those claims that it believes may be both
inappropriate and among the most potentially important--that is,
confidentiality claims relating to health and safety studies performed
by the chemical companies involving chemicals currently in commerce.
The EPA official responsible for initiating challenges to
confidentiality claims told us that EPA challenges about 14 such claims
each year, and that the chemical companies withdraw nearly all of the
claims when challenged.
Officials who have various responsibilities for protecting public
health and the environment from the dangers posed by chemicals believe
that having access to confidential TSCA information would allow them to
examine information on chemical properties and processes that they
currently do not possess and could enable them to better control the
risks of potentially harmful chemicals. For example, on the basis of a
study performed by the State of Illinois with the cooperation of
chemical companies and EPA, Illinois regulators found that toxicity
information submitted under TSCA was useful in identifying chemical
substances that should be included in contingency plans in order to
alert emergency response and planning personnel to the presence of
highly toxic substances at facilities. Additionally, the availability
of this information could assist the states with environmental
monitoring and enforcement. For instance, using TSCA data, Illinois
regulators identified potential violations of State environmental
regulations, such as cases where companies had submitted information to
EPA under TSCA but failed to submit such information to the states as
required.
Likewise, the general public may also find information provided
under TSCA useful. Individual citizens or community groups may have a
specific interest in information on the risks of chemicals that are
produced or used in nearby facilities. For example, neighborhood
organizations can use such information to engage in dialogue with
chemical companies about reducing chemical risks, preventing accidents,
and limiting chemical exposures.
TSCA's provisions are in contrast to those of some foreign
Governments' environmental laws, such as Canada, which authorizes its
environmental agency to share confidential business information with
other Governments under agreements or arrangements where the Government
undertakes to keep the information confidential. Chemical industry
representatives told us that the industry also sees benefits in
allowing EPA to share information with other countries in order to
harmonize chemical assessments among developed countries and improve
chemical risk assessment methods by allowing cooperation on improving
models used to predict chemical toxicity. The chemical industry is
concerned, however, that confidential information be protected from
inappropriate disclosure. These chemical industry representatives told
us that some countries currently do not have adequate procedures for
protecting confidential business information. However, they suggested
that the policies and procedures EPA currently uses to protect
confidential information are appropriate. Accordingly, they said that
the chemical industry would not object to TSCA revisions allowing EPA
to share confidential information with foreign countries and
organizations, provided that such revisions contain specific reference
to safeguards that EPA would establish and enforce to ensure that those
receiving the information have stringent policies and procedures to
protect it.
Our June 2005 report included two recommendations for addressing
the problems we identified related to the confidential business
information provisions of TSCA. We recommended that EPA revise its
regulations to require companies to reassert claims of confidentiality
within a certain period after the information is initially claimed as
confidential. We also recommended that the Congress consider amending
TSCA to authorize EPA to share with the states and foreign Governments
the confidential business information that chemical companies provide
to EPA, subject to regulations to be established by EPA in consultation
with the chemical industry and other interested parties that would set
forth the procedures to be followed by all recipients of the
information in order to protect the information from unauthorized
disclosures. EPA did not disagree with the report's findings and is in
the process of implementing several of our recommendations. For
example, EPA is currently launching a pilot project to review claims of
confidentiality for data on certain older chemicals.
concluding observations
Mr. Chairman, EPA's efforts to encourage companies to voluntarily
provide data on existing chemicals is commendable. However, the
fundamental and historical problems the agency has experienced with
utilizing its authorities under TSCA continue to limit EPA's ability to
manage its chemical review program and assess chemical risks. In this
respect, EPA faces considerable difficulties using its authorities to
require testing of existing chemicals, which prevents the agency from
reviewing substantially more chemicals in less time than it could if it
had the authority to require chemical companies to provide test data on
chemicals once they have reached a substantial production volume.
Moreover, EPA's ability to provide the public with information on
chemical production and risks is hampered by the strict confidential
business information provisions of TSCA. While protecting such
information is a legitimate concern, TSCA currently prohibits EPA from
disclosing much data for important purposes such as assisting State
agencies in carrying out their environmental management
responsibilities and foreign Governments in harmonizing international
chemical assessment approaches--a goal generally shared by these
Governments and the chemical industry. We believe the actions that we
have recommended to both the Congress and EPA would go a long way in
addressing the challenges EPA, faces in exercising its authorities
under TSCA.
Mr. Chairman, this concludes my prepared statement. I would be
happy to respond to any questions that you or Members of the Committee
may have.
______
Responses by John B. Stephenson to Additional Questions
from Senator Inhofe
Question 1. In the 2005 report, GAO presents statistical data on
the number of chemicals for which EPA has required testing or the
number of risk reduction actions EPA has taken. Yet you provide no such
information for Canada and the European Union. In fact, in the case of
the European Union, REACH doesn't even exist yet. Without that data,
isn't it impossible for us to make a direct, law-to-law comparison as
to the effectiveness of these programs?
Response. Our reports in June 2005 (Chemical Regulation: Options
Exist to Improve EPA's Ability to Assess Health Risks and Manage Its
Chemical Review Program; GAO-05-458) and in November 2005 (Chemical
Regulation: Approaches in the United States, Canada, and the European
Union; GAO-06-217R) provided descriptive information on differences in
the approaches to chemical regulation in the United States under TSCA;
Canada under the Canadian Environmental Protection Act (CEPA); and the
European Union (EU) under current legislation and under the EU's
proposed legislation known as REACH (Registration, Evaluation and
Authorization of Chemicals). Our reports did not compare the relative
effectiveness of these programs nor did they provide information on the
number of chemical tests required by or the number of control actions
taken under these programs. EPA officials told us that simply counting
the number of control actions would not provide an adequate comparison
of the effectiveness of various national chemical control programs
because counting control actions would not factor in voluntary programs
or companies' efforts to reduce chemical risks by switching to safer
chemicals. Moreover, because the overall statutory and regulatory
approaches to chemical regulation differ among nations, it would be
difficult to make direct comparisons of effectiveness. Both Canadian
and EU officials told us that concerns over the lack of data on
existing chemicals, coupled with difficulties in obtaining data needed
to adequately assess the risk of those chemicals, have caused officials
in those countries to consider revising their basic chemical
regulations.
Question 2. You stated in the report summary that you are unsure if
the information collected under HPV will help EPA determine the risks
of HPV chemicals. What do you suppose the information will be used for,
then? Is it really necessary to always have a comprehensive data set to
determine risk? Isn't a more targeted, tiered and risk-based approach a
standard used worldwide?
Response. The screening level information gathered under the HPV
Challenge Program will be used to make preliminary judgments about the
need for further testing or evaluation of high production volume
chemicals. However, any further action beyond the voluntary collection
of information by EPA requires the use of TSCA provisions that EPA has
found difficult to use, as noted in our prior reports.
We have not recommended that EPA develop a comprehensive data set
on all chemicals, and we have encouraged the agency to target its
efforts at those chemicals that pose the greatest risks. EPA, under the
HPV Challenge Program, collects a data set on program chemicals known
as the Screening Information Data Set (SIDS) that was developed by the
Organization for Economic Cooperation and Development (OECD). The data
set includes information on the identity of the chemical; its uses,
sources and extent of exposure; physical and chemical properties;
environmental fate; and certain limited toxicity data for humans and
the environment. This information allows EPA to make an informed,
preliminary judgment about the hazards of HPV chemicals. While the data
do not fully measure a chemical's toxicity, it can be used to determine
the relative hazards of chemicals and to judge whether additional
testing or assessment is necessary. Because of the lack of availability
of basic toxicity information on most high volume chemicals prior to
1998, we believe that the HPV Challenge Program is an important first
step in obtaining needed basic toxicity information.
However, once the information has been obtained, EPA still faces
hurdles in requiring additional testing and/or controlling chemicals
that EPA believes will pose an unreasonable risk to human health and
the environment. As noted in our June 2005 report, before EPA can issue
a rule requiring companies to perform additional testing, the agency
must demonstrate that a chemical may present an unreasonable risk to
human health or the environment or will be produced in sufficient
quantities to present substantial risk to humans or the environment.
Consequently, EPA has used its authorities to require testing for fewer
than 200 of the 62,000 chemicals in commerce when EPA began reviewing
chemicals under TSCA in 1979. In addition, if EPA believes banning or
restricting the manufacture or use of a chemical is necessary to
protect human health or the environment, it must produce substantial
evidence in the rulemaking record and must prove that the chemical will
present an unreasonable risk to human health and/or the environment.
Because the act's legal standards are so high, EPA has issued
regulations under the act to ban or limit the production of only five
existing chemicals or groups of chemicals.
We have not performed work to determine the approaches or the most
appropriate types of approaches used by various nations to regulate
commercial chemicals. However, on the basis of the results of our work
involving TSCA, we have encouraged EPA to target its limited resources
on those chemicals that pose the greatest risks to human health and the
environment.
Question. You mention in the June 2005 Report that EPA has limited
ability to collect data on existing chemicals. EPA has collected
information on about 2,000 existing chemicals so far under the HPV
Challenge. Considering Canada has primarily used modeling to screen
chemicals and REACH isn't even a law yet, has any other country or
region in the world collected SIDS base sets anywhere near 2,000
chemicals?
Response. We have not performed any work to determine the amount of
data collected on existing chemicals in Canada or the EU. Nevertheless,
according to EPA officials, the HPV Challenge Program will collect more
information in a short amount of time than has been collected to date
in Canada and the EU. We have not verified the information that EPA
claims was submitted under the program nor determined the quality of
any of the information submitted.
Our June 2005 Report stated that EPA has limited ability to collect
data on existing chemicals in the TSCA inventory (not just the high
production volume chemicals). It was the lack of basic toxicity
information that led EPA to create the High Production Volume (HPV)
Challenge Program in order to gather basic toxicity information on
those chemicals produced at one million pounds or more. Under the
program, EPA collects basic level screening data on HPV chemicals in
order to determine the relative hazards and to judge if additional
testing is necessary. This allows EPA to make a preliminary judgment
about the hazards of HPV chemicals as the data generally do not fully
measure a chemical's toxicity. In effect, the HPV Challenge program
provides the first in a series of steps needed to adequately assess and
manage chemical risks. While it is an important first step in
collecting information on existing chemicals, subject matter experts
have noted some problems with the HPV Challenge Program. First,
information submitted by companies thus far has not been reviewed to
determine its quality or completeness. Second, the majority of the data
submitted under the program are generated from models, not actual
tests. Finally, rather than submitting information on individually
designated chemicals, 80 percent of the chemicals are grouped into
broad categories for data submission.
______
Responses by John B. Stephenson to Additional Questions
from Senator Boxer
Question 1. Mr. Stephenson, TSCA's chemical inventory currently has
more than 82,000 substances. Could you please describe the extent of
EPA's lack of safety data, in particular for children, with respect to
the chemicals in TSCA's inventory?
Response. TSCA does not generally require companies to develop any
safety information, absent EPA action, for either new or existing
chemicals. While TSCA authorizes EPA to promulgate rules requiring
testing of chemicals if EPA has made certain findings, TSCA does not
require chemical companies to test chemicals prior to their use in
commerce for toxicity or to gauge exposure levels before they are
submitted for EPA's review, and chemical companies generally do not
voluntarily perform such testing. Further, EPA cannot require chemical
companies to test existing chemicals and provide the resulting test
data to the agency unless EPA first determines on the basis of risk or
production and exposure information that the chemicals warrant such
testing. EPA has used its authority to require testing for fewer than
200 of the 62,000 chemicals in commerce when EPA began reviewing
chemicals under TSCA in 1979.
In response to several studies that showed that there were
relatively few High-ProductionVolume (HPV) chemicals for which an
internationally agreed upon set of hazard screening data was available
to the public, EPA, in cooperation with industry, environmental groups,
and other interested parties initiated the HPV Challenge Program in
late 1998. The program was created to ensure that a baseline set of
data on approximately 2,800 high-production-volume-chemicals would be
made available to the public. While the HPV Challenge Program looks
promising in that, if successful, it will provide EPA and the public
with information not previously available on the properties of
chemicals produced at large volumes in the United States, this program
may not provide enough information for EPA to use in making risk
assessment decisions. While the data in the HPV Challenge Program may
help EPA prioritize chemicals of concern for additional review and
assessment, the data may not present sufficient evidence for EPA to
determine whether a reasonable basis exists to conclude that the
chemicals present an unreasonable risk of injury to health or the
environment and that regulatory action is necessary. As our earlier
reports have indicated, EPA has found it difficult to use the
authorities provided under TSCA to require companies to develop such
data and to restrict the uses or production of chemicals.
With respect to children's safety, GAO has not performed the work
necessary to determine the extent to which EPA lacks data specifically
on the adverse effects of chemicals on children. However, the
limitations noted above would also apply to data on risks to children.
Question 2. Mr. Stephenson, in 1991, the Fifth Circuit Court of
Appeals struck down EPA's rule to ban most uses of asbestos. In your
view, what is the practical impact of that decision on EPA's ability to
use TSCA to enforce mandatory protections on chemicals that present a
risk to public health, including to children?
Response. In 1979, EPA began exploring rulemaking under TSCA to
reduce the risks posed by exposure to asbestos. Based upon its review
of over 100 studies of the health risks of asbestos as well as public
comments on the proposed rule, EPA concluded that asbestos was a
potential carcinogen at all levels of exposure. In 1989, EPA
promulgated a rule under TSCA section 6 prohibiting the future
manufacture, importation, processing, and distribution of asbestos in
almost all products. Some manufacturers of asbestos products filed suit
against EPA, arguing, in part, that the rule was not promulgated on the
basis of substantial evidence regarding unreasonable risk. In October
1991, the U.S. Court of Appeals for the Fifth Circuit agreed with the
chemical companies, concluding that EPA had failed to muster
substantial evidence to justify its asbestos ban and returning parts of
the rule to EPA for reconsideration.
In its ruling, the court concluded that EPA did not present
sufficient evidence to justify the ban on asbestos because it did not
consider all necessary evidence and failed to show that the control
action it chose was the least burdensome regulation required to
adequately protect human health or the environment. As articulated by
the court, the proper course of action for EPA, after an initial
showing of product danger, would have been to consider each regulatory
option, beginning with the least burdensome, and then assess the costs
and benefits of each option. The court further criticized EPA's ban of
products for which no substitutes were currently available stating
that, in such cases, EPA ``bears a tough burden'' to demonstrate, as
TSCA requires, that a ban is the least burdensome alternative.
While it is not possible to determine how EPA would have
implemented TSCA in the absence of the court's decision, it can be
noted that since the decision EPA has exercised its authority to ban or
limit the production or use of an existing chemical only once (for
equivalent chromium). In this case, EPA officials said that they had
started the process for promulgating the rule for equivalent chromium
years prior to the asbestos decision. EPA officials have suggested that
the court's ruling in the asbestos case created a difficult standard
for the agency to meet by requiring that, before EPA takes regulatory
action, it demonstrate that its regulations use the least burdensome
approach to mitigating unreasonable risks and that its rulemaking is
supported by substantial evidence. With respect to children, we note
that TSCA contains no provisions specifically directing EPA to address
the risks that chemicals pose to children's health.
Question 3. Mr. Stephenson, Government Accountability Office
reports going back to 1984 have noted that EPA lacks needed toxicity
data on chemicals. GAO reports from 1994 and 2005 discuss TSCA's
industry-friendly standards as an impediment to EPA's implementing non-
voluntary restrictions on the use or production of chemicals. All of
these reports also note that EPA lacks adequate resources to fully
implement the program. In your opinion, are TSCA's current provisions
the best way for Congress to protect individuals, including children,
from dangerous exposures to toxic chemicals? Or, should we consider
modifying the law?
Response. As we reported in 1994 and 2005, and testified on August
2, 2006, there are several actions that the Congress and EPA could take
to improve EPA's ability to assess the health and environmental risks
of chemicals and to manage its chemical review program. In our reports
and testimony, we have recommended that the Congress consider (1)
providing explicit authority for EPA to enter into enforceable consent
agreements under which chemical companies are required to conduct
testing; (2) giving EPA the authority under section 4 of TSCA to
require chemical substance manufacturers and processors to develop test
data based on substantial production volume and the necessity for
testing; and (3) authorizing EPA to share with the states and foreign
Governments the confidential business information that chemical
companies provide to EPA, subject to regulations to be established by
EPA in consultation with the chemical industry and other interested
parties, that would set forth the procedures to be followed by all
recipients of the information in order to protect the information from
unauthorized disclosures.
Moreover, we have identified additional options that the Congress
could consider to strengthen EPA's ability under TSCA to assess
chemicals and control those found to be harmful. In this regard, the
Congress could strengthen TSCA by:
requiring the systematic testing of existing chemicals;
requiring chemical companies to provide additional information on
new chemicals; and
reducing EPA's evidentiary burden to take action under TSCA.
Detailed descriptions of the above options are contained in our
prior reports on TSCA. While such options exist to make TSCA more
effective, their likely benefits in protecting human health and the
environment would need to be weighed against the potential costs of
implementing them.
__________
Statement of Michael P. Walls, Managing Director of Regulatory and
Technical Affairs, American Chemical Council
i. introduction
The American Chemistry Council (ACC) appreciates this opportunity
to appear before the Committee to discuss the U.S. chemical regulatory
control framework, notably the Toxic Substances Control Act (TSCA). In
our view, TSCA is a sound statutory and regulatory system. It is a
robust vehicle that can effectively address emerging chemical issues,
while retaining sufficient flexibility to promote innovation and the
active involvement of chemical manufacturers in the safe management and
use of chemicals.
ACC is the national trade association whose member companies
represent more than 90 percent of the productive capacity for basic
industrial chemicals in the United States. ACC member companies are on
the cutting-edge of technological innovation and progress, whose
products provide significant benefits--benefits that save lives,
improve health, protect our food supply, and provide jobs throughout
the Nation.
ACC member companies are committed to implementing a set of goals
and guidelines that go above and beyond Federal regulation on health,
safety, security, and the environment. Since the Council adopted
Responsible Care in 1988, our members have reduced emissions by 75
percent and achieved a safety record more than four and a half times
better than the average for the manufacturing sector overall. ACC
supports the safe management and use of chemical products. The
industry's regulatory compliance and proactive product stewardship
programs allow ACC's members to manage appropriately the wide range of
products made by the business of chemistry.
These comments address the statutory and regulatory safeguards
built into the current framework for the management of chemicals; some
of the voluntary programs that our industry has committed to that build
on those safeguards; and why it is important to ensure that TSCA
remains a flexible, science-based statute that can address new
scientific challenges and promote technological innovation.
ii. the overall framework for chemicals management
TSCA is not the only statute that controls risks from chemicals
products on the market, although it is an important piece of the
overall regulatory framework. Other statutory requirements focus on
chemical uses that may create direct human exposures. For example,
information and registration requirements for pesticides are covered
under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
The standards for manufacturers of pharmaceuticals, food additives,
food packaging, and cosmetics are addressed in the Federal Food, Drug
and Cosmetic Act (FFDCA). The Federal Hazardous Substances Act (FHSA)
applies to substances used in consumer products. Some 14 different
Federal statutes play a role in regulating chemical manufacture, use,
distribution and disposal, complemented by State regulatory programs in
specific areas.
Unlike the environmental media-driven statutes such as the Clean
Air Act, Congress did not set specific metrics or deadlines for actions
under TSCA. Instead, Congress has provided the Environmental Protection
Agency (EPA) tools to gather information so that risks can be
identified and managed, and unreasonable risks eliminated. TSCA was
enacted in 1976 in order to prevent ``unreasonable risk of injury to
health or the environment associated with the manufacture, processing,
and distribution in commerce, use, or disposal of chemical
substances.'' Congress properly recognized that while a variety of laws
existed to ensure the safety of products, EPA needed tools to identify
potential risks to health and the environment, and to take the steps to
manage those risks appropriately.
TSCA was intended to be flexible enough to enable a variety of
regulatory responses, and address a variety of needs, including support
for regulatory action under other statutes. ACC counts this flexibility
as one of the key strengths of TSCA, particularly as science,
technology, and our ability to understand hazards, mechanisms of
action, and exposures to chemicals have evolved.
In TSCA, Congress gave EPA a variety of tools to empower the agency
to gather information, assess that information, and initiate action to
address any risk which, in the agency's view, is unreasonable. Key
provisions of TSCA authorize EPA to:
Establish an inventory of chemical substances which had been on
the market when TSCA was enacted (the ``existing'' substances), as well
as any substance later reviewed and approved by EPA under the ``new
substance'' provisions. (TSCA Scc. 8(b))
Require the review and approval of any ``new'' substance prior to
manufacturing that substance. Companies submitting a pre-manufacture
notice (PMN) are required to submit any available health or
environmental test information that they may already have in their
possession. In addition to available test information, the manufacturer
must provide information on the chemical identity and structure, and
anticipated uses, production volume, by-products, human exposures and
disposal practices. EPA has established some 35 PMN policies that
provide early guidance to submitters on substances that have particular
characteristics. EPA has also developed sophisticated and powerful
computer modeling--using data gathered over many years--that help
predict a chemical's physical and chemical properties, health hazards,
exposure potential, and potential environmental effects. If EPA finds
the information provided inadequate, EPA has the authority to ask
companies for additional information under this provision. (TSCA Sec.
5)
Limit ``new'' uses of existing chemical substances under
authority known as a ``significant new use rule.'' Using this
authority, EPA has successfully restricted well over 1,000 substances.
These restrictions range from establishing maximum production amounts,
dictating allowable uses, instructing on appropriate disposal methods,
or other measures designed to manage risk. (TSCA Sec. 5)
Require companies to test chemicals to assess potential risks to
health or the environment. Chemicals that may need test data are
brought to EPA's attention in a variety of ways. For example, the
Interagency Test Committee (established under TSCA and comprised of
experts from eight designated Federal agencies and institutes, and a
number of other liaison members) regularly evaluates and recommends
chemicals to test. EPA may also select chemicals on the basis of
information provided under any of the information collection sections
of the statute. (TSCA Sec. 4)
Regulate existing chemical substances through a variety of
mechanisms, including use restrictions, production limitations, warning
labels, record keeping, customer notifications, or in the most extreme
cases, outright bans. Although EPA has successfully pursued a number of
actions under this part of TSCA, one case is routinely cited (in ACC's
view, incorrectly) for the proposition that ``Section 6 demonstrates
that TSCA is broken.'' Contrary to popular perception, the Corrosion
Proof Fittings opinion does not establish a failing in the statute--it
simply established that EPA did not follow Congress' directive. In
fact, EPA has successfully regulated other substances under TSCA
section 6 including halogenated aromatic compounds, heavy metals, and
fibers. (TSCA Sec. 6)
Require companies to: (a) keep records on allegations of
significant adverse reactions; (b) report information on chemical uses
and exposures; (c) provide EPA with copies of unpublished health and
safety studies; and (d) submit all information in their possession that
suggests a chemical presents a substantial risk of injury to health or
the environment. (TSCA Sec. 8)
Require companies to provide notifications of anticipated exports
of substances subject to test rules under Section 4, and those subject
to orders or rules under Sections 5, 6 and 7. The facts around TSCA
implementation comprise an impressive record:
From 1979 though 2003, EPA reviewed approximately 36,000 new
chemicals. More than 3,000 were subject to some form of regulation as a
result of EPA's reviews. More than 1,200 chemicals are subject to
consent orders negotiated by the manufacturers with EPA. Such consent
orders typically prescribe limitations on use, workplace practices,
labeling requirements, and release and disposal restrictions.
In more than 500 other cases, EPA permitted the new substance to
be produced without a consent order, but at the same time promulgated a
``significant new use rule'' (SNUR) that prohibits certain uses of the
substance without further prior review by EPA. In approximately 870
cases, the submitter of the pre-manufacture notice agreed to conduct
additional testing in response to EPA requests. In some 1,550 cases,
the submitter withdrew the pre-manufacture notice in the face of EPA
concerns and likely regulatory requirements.
Since TSCA was enacted, several hundred existing chemicals have
been subject to testing requirements imposed by EPA under TSCA Section
4. In addition to TSCA testing requirements, many companies conduct
hazard and environmental fate and effects testing on their products,
including sometimes very sophisticated testing that goes well beyond
the testing requirements typically imposed by EPA under TSCA. Indeed,
the volume of testing that occurs outside of TSCA on a voluntary basis
far exceeds testing conducted pursuant to regulatory requirements. When
toxicity testing of chemicals is conducted under the auspices of a
chemical specific panel of the American Chemistry Council, a copy of
the final study report is automatically provided to EPA and several
other regulatory Agencies.
EPA has developed a Preliminary Assessment Information Rule
(PAIR) reporting form that it frequently uses to gather information
about the manufacture, use, potential for workplace exposure and
environmental release of specific chemicals. To date, EPA has required
manufacturers to complete this form for approximately 475 chemicals.
EPA also has exercised its authority to require the submission of
existing health and safety data for approximately 1,000 chemicals.
Since TSCA was enacted, well over 10,000 ``substantial risk''
reports have been filed with EPA under Section 8(e).
iii. voluntary programs under tsca
As noted earlier, TSCA provides flexibility to EPA in adapting
voluntary programs and initiatives that complement the Agency's
regulatory programs. The High Production Volume Challenge (HPV)
Program, for example, has provided more hazard information, on more
chemicals, faster than any other program EPA has ever established.
HPV Challenge Program
In 1998, the chemical industry, working with EPA, Environmental
Defense and others, developed the HPV Program. This unprecedented
voluntary initiative had the goal of making uniform health and
environmental screening information on high production volume (HPV)
chemicals publicly available by the end of 2005. Through the HPV
Challenge Program, more than 300 sponsoring manufacturers volunteered
to provide hazard-screening information on 2,222 HPV chemicals.
For each of the chemicals sponsored in the program, industry has
provided 17 types of information, including summarized results in four
categories: physical-chemical properties, environmental fate, and
potential to induce toxicity in aquatic organisms and humans. Data to
be summarized for human toxicity include studies assessing acute
toxicity, sub chronic toxicity, genotoxicity, and developmental and
reproductive toxicity.
All of the information collected under the HPV Program is important
and relevant for evaluating a chemical's potential impact on human
health and the environment. Additionally, test categories such as
genotoxicity and acute, developmental and reproductive toxicity are
specifically relevant to protecting children's health.
The standard battery of toxicity tests employed by EPA for HPV (and
harmonized internationally under OECD) includes tests specifically
designed to evaluate endpoints that provide information on a
substance's potential to pose a health hazard:
to development in the womb;
to growth and reproduction;
from acute poisoning;
to cell components that could possibly trigger transformation
into cancer later in life;
to the nervous system (observation for toxicological effects on
the nervous system are included as a component of the protocol in every
animal toxicity test);
to all major organ systems, including the nervous system.
Thus, the standard battery of TSCA HPV tests is both relevant and
important to assessing potential health hazards. Results from these
tests can and are being used to decide what specific, additional
toxicity tests are scientifically warranted and necessary to more
completely understand specific organ-system hazards, and to more fully
characterize the dose-response relationship.
The HPV program, supported by EPA's HPV Information System (HPVIS),
has made existing health and environmental effects data sets publicly
available on approximately 95 percent (by volume) of the chemicals
currently in commerce in the United States
More importantly, EPA is using the HPV data to make decisions on
priorities for further review. All HPV data--which was always intended
for screening purposes and not as a complete data set--are being
assessed in EPA's screening mechanism. The HPVIS screening process was
designed by an EPA stakeholder group (the National Pollution Prevention
and Toxic Advisory Committee) after detailed review of the needs of a
variety of data users. The first step is an automated review, resulting
in a prioritization of all chemicals for detailed evaluation. ACC
supports that process, and looks forward to its timely completion.
Extended HPV Program
In March 2005, before the end of the HPV Challenge Program, the
chemical industry extended and broadened its current work on HPV
chemicals in two ways. First, companies are asked to provide health and
environmental information for 574 ``new'' HPV chemicals--chemicals that
did not qualify as HPV chemicals at the start of the original program,
but which now meet the volume threshold according to EPA's 2002
Inventory. Second, the EHPV Program increases the scope of information
being collected for all HPV chemicals. In addition to gathering health
and environmental information, companies are asked to provide
information on use and exposure for both the ``Extended'' HPV as well
as the original ``Challenge Program'' substances. In this way, the EHPV
Program will provide EPA and the public with an extensive source of
chemical safety information on HPV chemicals.
Together, these voluntary programs are exemplary illustrations of
how industry has taken responsible action, supported through the
flexibility inherent in TSCA. All of the important information
generated in these voluntary programs will be used by EPA to prioritize
HPV chemicals for further evaluation, risk characterizations and risk
assessment.
Voluntary Children's Chemical Evaluation Program
EPA announced its pilot Voluntary Children's Chemical Evaluation
Program (VCCEP) in December 2000 to assess certain chemicals for
potential risks to children through a series of tiered screens and
tests. It was developed as an alternative to a TSCA Section 4 test
rule. The VCCEP pilot is evaluating both hazard and exposure
information on 20 chemicals voluntarily submitted by thirty five
companies and ten consortia. The key question that the VCCEP aims to
answer is whether the potential hazards, exposures, and risks to
children have been adequately characterized, and if not, what
additional data are necessary.
Companies participating in VCCEP present a hazard assessment,
exposure assessment and risk assessment on their chemical to an
independent peer consultation panel which then makes a recommendation
to EPA about additional data needs under the tiered evaluation
framework of the program. EPA then makes a data needs assessment about
the chemical.
The program is proceeding well and is currently about half
completed. Industry has lived up to its commitments under the program.
ACC believes this pilot program has been very successful at affirming
the viability and improved efficiencies of tiered approaches to
chemical evaluation. It has also improved the practice of children's
health exposure assessments and has proved the value of an independent
peer consultation panel to make data needs recommendations. Although
EPA data needs decisions have taken a long time, the pilot VCCEP has
successfully evaluated many important chemicals, including brominated
flame retardants, vinylidene chloride, benzene, and acetone.
The program has shown that a one-size fits all, single tier test
battery approach to children's health questions would be wasteful of
laboratory animals, costly, inefficient and not nearly as informative
as the approach taken under VCCEP. At the end of the day, VCCEP is
providing a strong, scientific basis for deciding whether children's
risks from exposure to chemicals have been adequately characterized and
additional information is needed to make those characterizations.
Voluntary programs are conducted under the auspices of TSCA and
they play an important role in implementing the objectives of TSCA.
They permit companies to demonstrate their commitment to product
safety, and often result in information developed in ways that are
faster or less burdensome than would be the case under a regulatory
mandate.
iii. tsca meets new scientific and technological challenges
and promotes innovation
As science evolves, we learn more and more about the relationship
between chemistry and health. TSCA's framework is flexible enough to
meet new scientific questions that might be raised about the impact of
chemicals on health. Rather than amending TSCA to impose new
requirements each time thesenew questions arise about chemicals, the
law and EPA's implementation of it are flexible enough to address these
questions under a science and risk based framework. Concerns about
endocrine disruption, children's health, biomonitoring information and
nanotechnology can and are being addressed today under TSCA's
information collection, reporting, testing and risk management
provisions, (as well as under other existing statutes such as the Food
Quality Protection Act of 1996). These are just today's questions. New
scientific questions will continue to arise as science evolves. TSCA
provides a dynamic framework for anticipating these issues and
developing the scientific information needed to apply its many risk
management tools as appropriate.
TSCA's framework also promotes the development of innovative
chemistries and technologies. More new chemical notifications are filed
under TSCA than in any other major regulatory system, including Europe
and Japan. As a result, the business of chemistry in the United States
is acknowledged to be a world-leader in solutions that improve science
and technology. ACC has no doubt that TSCA has helped foster innovation
and a significant competitive position for the industry in the world
economy. Further, TSCA has contributed greatly to the national economy
and the relative position of the U.S. chemical industry in the global
business of chemistry.
The term ``green chemistry'' has become a popular term recently,
and some have argued that TSCA does not do enough to encourage the
production of chemicals that have little or no toxic effects. ACC
members believe in green chemistry--in fact they are among the premier
practitioners of green chemistry, a fact demonstrated by the regular
recognition of ACC member companies in programs such as the
Presidential Green Chemistry Awards.
It is important to recognize that green chemistry is a framework
that aligns technology and innovation with improvements in the health
and environmental ``footprint'' of materials used in our society. Green
chemistry is not just about products, it is also about the improvements
and enhancements in production processes.
ACC agrees that Government can and should provide encouragement for
such collaborations through the sharing of expertise, financial support
for research, information exchange and public education. In fact, a
variety of Federal agencies (including EPA and DOE), companies,
professional associations such as the American Chemical Society, and
universities are working together to encourage green chemistry
strategies.
However, it is inappropriate to blame TSCA for the alleged lack of
``green chemistry'' approaches. The fact that the statute does not
explicitly address green chemistry is not surprising, nor is it
important. In ACC's view, TSCA appropriately does not dictate how the
process of innovation and collaboration should occur, and in what
areas.
iv. conclusion
The American Chemistry Council believes that the Toxic Substances
Control Act provides a high level of health and environmental
protection in the manufacture and use of chemical substances. Through
TSCA, EPA has significant regulatory authority to take measures
necessary to prevent or mitigate unreasonable risks. Moreover, TSCA
complements the industry's product stewardship programs, as do the
legal and marketplace forces that affect the industry.
ACC and its member companies appreciate this opportunity to comment
on TSCA.
______
Responses by Michael P. Walls to Additional Questions
from Senator Inhofe
Question 1. Mr. Walls, I am acutely aware that TSCA is one of the
few laws in the United States that directly impacts a company's ability
to sell goods in the marketplace. Can you comment on the effect on
innovation and the ability for small companies to compete if we impose
new regulations and made proprietary business information publicly
available?
Response. TSCA promotes innovation in the United States by making
it possible for EPA to quickly review new chemical products for their
potential health or environmental risks, and for companies to provide
EPA with essential health, safety and environmental information while
simultaneously keeping key commercial information confidential. A new
regulatory approach that would require proprietary business information
to be made routinely available would likely have a severe negative
effect on innovation in the business of chemistry.
The issue of proprietary business information and TSCA cannot be
taken lightly. Congress clearly understood what types of data would be
covered by the statute, and built in strong protections for
confidential business information. TSCA's new chemical notifications
and other reporting requirements compel industry to provide a wealth of
sensitive data about chemical substances that have commercial value.
Examples of such data include:
A chemical identity of a new substance that may be a trade
secret, or which may not yet have received patent protection
The volume of the chemical that would be produced, which would
signal to competitors the potential market size for the chemical
The preferred molecular weight range for a new commercially
valuable polymer
Impurities, which can signal to those competitors skilled in the
art the manufacturing process and or precursor substances
Proprietary manufacturing processes
The formulations of commercially valuable products and
intermediates
The commercial uses for which a new or existing substance has
value
Since the business of chemistry involves substantial investment in
research and development, and results in the development of significant
technology, intellectual property and valuable trade secrets, it is
essential that the provisions to protect confidential information not
be weakened. The industry's $23 billion annual investment in research
and development relies heavily on the ability to protect that
investment. Unfortunately, our desire to protect proprietary business
information is often misconstrued as a desire to hide safety
information. This is simply not the case. ACC member companies
routinely provide all manner of health, safety and environmental
information on their chemicals. This includes the submission of data
summaries for more than 11,000 human health studies during the course
of the High Production Volume Chemical Challenge program.
Question 2. Mr. Walls, in a recent congressional staff briefing,
GAO stated that the ACC doesn't disagree with the GAO 2005 report. Is
that true?
Response. ACC does not agree with GAO's statement. Approximately a
year ago GAO asked our reaction to a recommendation that EPA work to
share confidential information with other Governments. While we
indicated that we would certainly support a discussion of that
recommendation, we did not discuss whether that change should be made
in a statutory change or some other administrative change. Moreover, we
noted that this change was not a sufficient reason to open TSCA to
amendment, but we agreed that there were situations in which an ability
to share information could be beneficial.
In its July 2005 report, GAO made seven specific recommendations
related to TSCA. The GAO recommendations focus on efforts to improve
EPA's ability to assess the health and environmental risks of chemicals
and to improve EPA's management of its chemical review program. Again,
GAO did not recommend wholesale changes to TSCA nor did it suggest that
other regulatory systems, such as the European Union's REACH system,
should be considered.
Three of the seven recommendations were matters for Congressional
consideration. The first recommendation was to provide explicit
authority for EPA to enter into enforceable consent agreements. ACC
believes that the Agency and companies should have the ability to
negotiate consent agreements --and that EPA already has the authority
to negotiate those agreements. In its response to GAO, EPA noted that
an amendment was not necessary for enforceable consent agreements.
The second recommendation was to provide EPA additional authority
to require manufacturers to develop test data based on substantial
volume and the necessity for testing. ACC believes that TSCA already
provides EPA with sufficient authority to require testing under Section
4 and that additional authority beyond section 4 is not necessary.
The third recommendation for Congressional consideration was to
authorize EPA to share with states and foreign Governments the
confidential information that chemical companies provide to EPA,
subject to regulations to be established by EPA in consultation with
the chemical industry and other interested parties. ACC recognizes the
potential benefit that could be achieved in sharing relevant risk
assessment information among the states and foreign Governments. We
strongly believe that any Government groups accepting CBI from EPA must
provide the same level of protection to the information as EPA does. In
addition, we are concerned about whether the U.S. Government would have
jurisdiction to police or penalize those Governments that allow
confidential information to be released. Sharing CBI among the states
and/or other foreign Government is of interest to ACC, but we do not
believe it is sufficient to re-open the statute for change.
The remaining four recommendations are focused on EPA
implementation. They include the following:
1. Development and implementation of a methodology to use HPV
information for further review: This was always the goal of the HPV
program. We understand that EPA will be using the screening process
developed under the auspices of the National Pollution Prevention and
Toxic Advisory Committee. We fully support EPA's efforts to do so.
2. Issue a Section 8 test rule to require companies to submit to
EPA copies of all studies and other information submitted to other
Governments: Neither ACC nor EPA believe that such a test rule is
necessary. In its response to the report, EPA recommended that ``other
more targeted approaches for collecting information which are directed
at EPA's domestic priorities, rather than foreign Government mandates,
may be more prudent.'' EPA has also indicated that such information
could be obtained by voluntary actions and that consideration of
Paperwork Reduction Act issues would impact Section 8 rulemakings. ACC
agrees with these EPA positions.
3. Develop a strategy for improving and validating models that EPA
uses: ACC endorses efforts to enhance the usefulness of EPA's models,
and we believe that the Agency has already taken action to validate and
improve its models.
4. Require companies to re-assert claims of confidentiality: ACC
believes that reassertion of confidentiality claims for all information
submitted under TSCA would be extraordinarily costly and ineffective.
ACC acknowledges that there may be circumstances in which some
information originally claimed as confidential in a new chemical
notification may not need such protection after several years on the
market. However, requiring industry to reassert confidentiality claims
would impose additional, unnecessary costs on industry. It is also
unclear whether EPA would be able to accommodate the
``declassification'' of confidential information in its database.
I note that TSCA requires EPA to disclose information if it is
necessary to protect health and the environment against an unreasonable
risk of injury, and the statute requires manufacturers to share
information with EPA about adverse effects from chemical exposures.
There are established processes for EPA to seek the disclosure of CBI,
including the possibility that EPA can simply ask the owner of the
information for permission to release it. Congress struck an important
balance in TSCA between the public right to know and sensitive business
information.
This is also a subject that has been discussed with EPA's toxic
advisory committee (National Pollution Prevention and Toxic Advisory
Committee), and a pilot project is currently looking at what
opportunities might exist to address the issue of legitimate but
perhaps ``stale'' CBI claims.
Question 3. Some claim that TSCA actually serves as a barrier to
the introduction of newer, safer chemicals. Is this actually the case?
Response. ACC understands that some--notably Dr. Michael Wilson, in
his testimony to the Committee--argue that TSCA's failure to impose
substantial data requirements on all existing chemicals discourages
innovations in green chemistry. This argument is supported more by
speculation than facts. The fact is that more new chemical
notifications are filed in the United States than in any other country,
and that those new chemicals are the basis for replacing older existing
chemicals. As I noted in the response to Question 1, TSCA promotes
innovation in chemistry. In fact, the proportion of chemicals reported
on the TSCA Inventory Update Rule that have been through EPA's new
chemicals notification process continues to grow every year--reflecting
the maturation of markets as new chemicals gain acceptance and are seen
as effective replacements for other already established chemicals.
In our view, Government cannot dictate in statute or regulation
precisely how the process for innovation and collaboration should
occur. The fact that TSCA does not explicitly address ``green
chemistry'' is not surprising, nor is it important. Green chemistry
initiatives have existed within EPA and the industry for years, without
mention of this concept in TSCA. The chemical industry is highly
competitive, and of necessity is responsive to customer, market and
legal demands. TSCA helps the industry be responsive by promoting
innovation in both the industry's products and the processes in which
chemicals are made and used.
Question 4. There seems to be some confusion about the number of
chemicals actually in commerce. From some stakeholders we hear there
are 50,000, 60,000, even 100,000 chemicals in commerce! We are told the
number is really closer to 9,000. Which is it?
Response. We hear these inflated numbers all the time. In fact, the
larger numbers reflect the number of chemicals that are on the TSCA
Inventory, which is a historical database of all chemicals that were
entered into the system in 1979, plus all new chemicals added to the
inventory following review by EPA since then. The number of chemicals
actually in commerce is closer to 9,000. According to EPA figures, over
the past four Inventory Update Rules there have been an average of
about 9,000 non-polymeric chemicals in commerce in quantities of more
than 10,000 lbs/year. As the chemical industry has demonstrated through
the High Production Volume (HPV) and Extended HPV programs, hazard data
has been provided to EPA for some 93 percent of the chemicals in
commerce by volume--and our industry continues to work with EPA as that
data is used to prioritize EPA's activities.
______
Response by Michael P. Walls to an Additional Question
from Senator Jeffords
Question 1. Mr. Walls, do you believe that the chemical industry
would expend fewer resources if the EPA evaluated new chemicals on a
premarketing basis as opposed to a premanufacturing basis?
Response. The U.S. system for pre-manufacture review of new
chemical substances has spurred innovation, and has helped make the
United States a leader in bringing new products to market. According to
one study conducted for the OECD, in the United States an average of
425 non-polymeric substances are notified in the United States each
year, compared to 143 in Europe. Over the years EPA's Office of
Pollution Prevention and Toxic Substances (OPPT) has developed programs
and processes to evaluate new chemical notifications with data and
other information, using tools and models that ultimately make the
process easier, less expensive, and more efficient in terms of market
entry and animal welfare. Conversely, the EU's pre-market system with
fixed data requirements has led to markedly fewer new chemical
notifications, and at significantly greater expense. We believe that
the efficiencies created by the U.S. pre-manufacture system, together
with the flexible and tiered approaches to data requirements, actually
spur innovation and therefore generally result in the introduction of
newer and greener products faster than in other economies.
______
Responses by Michael P. Walls to Additional Questions
from Senator Boxer
inadequacy of tsca's testing requirements
Question 1. Mr. Walls, just this year, a National Academies of
Sciences report concluded, ``TSCA authorized EPA to review existing
chemicals, but toxicity and exposure information on them is typically
so incomplete that it does not support the review process. EPA can
require testing if it determines that a chemical meets a specific set
of criteria; however in vitro and whole-animal tests are rarely
required. Thus, the basis for establishing priorities and requiring
testing for industrial chemicals in the United States has not
progressed much over the last 20 years.''
Yet, you have testified today that, ``TSCA's framework is flexible
enough to meet new scientific questions that might be raised about the
impact of chemicals on health.''
Do you think that, in fact, a decades old testing system raises
some concerns about TSCA's ability to protect public health?
Response. The National Academy of Sciences report\1\ referred to in
this question did not fully consider all programmatic aspects of TSCA.
TSCA is not just a testing statute. Congress enacted TSCA with an even
broader goal of preventing unreasonable risks of injury to health or
the environment associated with the manufacture and use of chemical.
And yes, we believe that as a statutory framework, Congress got it
right. In fact, Congress was remarkably prescient in providing EPA with
a strong yet dynamic framework which includes a range of tools that can
be adapted as science and our understanding of health and environmental
risks evolve. This is evident in EPA's ability to develop and
disseminate the guidelines for conducting both animal and non- animal
testing as we better understand mechanisms of action and refine our
assumptions. And this is evident in TSCA's ability to manage new types
of chemistries, including the products of nanotechnologies.
---------------------------------------------------------------------------
\1\Toxicity Testing for Assessment of Environmental Agents: Interim
Report (2006).
---------------------------------------------------------------------------
Unlike media or product specific statutes, TSCA is largely a
collection of tools. These tools--the authorities to compel action by
the regulated community, and the power to act when necessary--are
entrusted to the Office of Pollution Prevention and Toxics. ACC and
others have from time to time expressed views on whether or not OPPT is
appropriately or effectively utilizing those tools. We are therefore
impressed that OPPT has formed a Federal Advisory Committee (the
National Pollution Prevention and Toxics Advisory Committee) to receive
input and advice on its implementation of TSCA. Following a period of
extensive input and stakeholder consultation, in February 2005 the
NPPTAC made detailed recommendations to EPA on how it should manage and
evaluate the wealth of health, safety and environmental information
provided to the Agency under the HPV Challenge Program. As you have
heard, OPPT is making important strides in this regard, and we believe
they are to be congratulated.
Furthermore, as envisioned under the voluntary HPV Challenge
program, the collection and public dissemination of hazard data for
high production chemicals was never meant to be the final step in
either company product stewardship or EPA's regulatory oversight. In
the NAS report, the efforts of the NPPTAC were not considered; most
likely because the NAS committee deliberations were occurring
simultaneous with the discussions of the NPPTAC which led to
development of NPPTC's ``HPV Chemical Screening Process \2\'' The OPPT,
using the NPPTAC screening recommendation, will formally evaluate the
data submissions on all of the data submitted for HPV sponsored
chemicals; each completed submission contains data on 18
internationally agreed ``SIDS''(Screening Information Data Set)
endpoints that are used as screening-level indicators of potential
hazardous effect (toxicity) for humans or the environment, as well as
environmental fate. In those cases where an evaluation raises specific
questions, or suggests a need for further inquiry, there are a range of
follow-up actions available to OPPT that would support voluntary or
regulatory hazard communication and risk management activities. These
could include gathering additional information on uses and exposures,
gathering additional information on potential hazards to support a more
in-depth characterization, evaluating adequacy of existing risk
management programs and practices including Federal and State
regulatory controls, etc.
---------------------------------------------------------------------------
\2\ National Pollution Prevention and Toxics Advisory Committee
(NPPTAC recommendations for a High Production Volume (HPV) Chemical
Screening Process (2005)
---------------------------------------------------------------------------
Indeed, the tiered testing and assessment framework of the HPV
Challenge illustrates a critical strength of TSCA --a robust and
flexible approach that allows EPA to focus attention and resources on
the substances that pose greatest concern from the perspective of
potential risk to human health and threats to the environment. The
standard battery of TSCA HPV tests is both relevant and important to
assessing potential health hazards. Results from these tests can and
are being used to decide what specific, additional toxicity tests are
scientifically warranted, and necessary to more completely understand
specific organ-system hazards, and to more fully characterize the dose
response relationship. The HPV Challenge program has shown that a
onesize-fits all, single tier test battery would be wasteful of
laboratory animals, costly, inefficient and not scientifically
justifiable. Indeed, support for the type of tiered testing and
evaluation processes embodied in the HPV and VCCEP efforts are endorsed
by the National Academy Committee, as stated in their 2006 report:
Existing test strategies include test batteries, tiered-testing
strategies, tailored approaches, and strategies that combine various
approaches. The committee finds that there are pros and cons of various
approaches but leans toward tiered testing with the goal of focusing
resources on the evaluation of the more sensitive adverse effects of
exposures of greatest concern rather than full characterization of all
adverse effects irrespective of relevance for risk-assessment needs.\3\
---------------------------------------------------------------------------
\3\National Pollution Prevention and Toxics Advisory Committee
(NPPTAC recommendations for a High Production Volume (HPV) Chemical
Screening Process (2005)
---------------------------------------------------------------------------
inadequacy of voluntary children's chemical evaluation program
Question 2. Mr. Walls, the American Chemistry Council has some
member companies, such as Bayer and BP, which participate on both the
EPA's Children's Health Protection Advisory Committee and the Agency's
Voluntary Children's Chemical Evaluation Program. Other members
participate on the Voluntary Children's Chemical Evaluation Program,
such as Monsanto and Proctor and Gamble.
On June 30, 2006, the EPA's Children's Health Protection Advisory
Committee wrote a letter to the Agency saying that the Committee had
``strong concerns with [the program's] structure and implementation.''
The primary goal of the program is to ensure publicly available
data on the risks to children's health from toxic chemicals. The
Children's Committee said that the ``program, as implemented, however,
is not on track to fulfilling its stated goal.'' The Committee
discussed problems with the lack of adequate peer review process,
industry selection of the reviewers and industry production of key
documents without EPA oversight.
While the committee is sounding the alarm about the program's
deficiencies, you have testified, ``The program is proceeding well. . .
'' and that ``ACC believes this pilot program has been very successful.
. . ''
Do you think that EPA should listen to its Children's Health
Committee and correct the problems highlighted with the program?
Response. ACC was involved in the multi-stakeholder development of
the VCCEP pilot program from its inception, as were members of the
environmental community (including Environmental Defense (ED)), the
animal welfare community and EPA. EPA launched the program, building on
the success of the HPV voluntary challenge program. The pilot was
designed to test out a tiered, integrated hazard and exposure
evaluation of chemicals, as opposed to a hazard only assessment. This
approach was chosen since children's exposures to chemicals are
probably more determinative of their risks than are the inherent
hazards of the chemicals, because their exposures can be unique to
their behaviors. The goal of the program was to determine whether
health risks to children from exposures to chemicals could be
adequately characterized--and to answer that question more effectively
than a hazard-only, animal intensive, one-size-fits-all testing program
could do. It's important to recognize the innovative nature of this
evaluation approach. ACC believes the program has met its objective and
has shown that a hazard based ``data gap'' is not necessarily a ``data
need.'' Devoting resources to ``data gaps,'' irrespective of whether
the specific information is actually needed (that is, necessary to
characterize children's risks with an adequate degree of scientific
certainty), would be wasteful of laboratory animals, costly,
inefficient and not scientifically justifiable.
The pilot has clearly shown that the tiered evaluation process, in
which hazard information is integrated with exposure information,
provides a strong scientific basis for deciding whether children's
risks have been adequately characterized, and if not, this approach
indicates which specific toxicity tests or additional exposure data/
information is needed to address this critical question. A recent
publication in the scientific literature illustrates the
accomplishments to date of the VCCEP\4\. Under the pilot, chemical
makers are providing extensive dossiers of both hazard and exposure
information on 20 chemicals identified by EPA. This information is
rigorously reviewed by an independent panel of scientists (peer
consultation) and then EPA makes the ultimate decision--based on the
peer consultation panel's report and its own review of all the
information--whether additional testing or data is needed to
characterize risks to children.
---------------------------------------------------------------------------
\4\P.R.D. Williams, J. Patterson and D.W. Briggs, VCCEP Pilot:
Progress on Evaluating Children's Risk and Data Needs. Risk Analysis
26: 781- 799 (2006).
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EPA has not yet begun its planned mid-course evaluation of VCCEP,
but when it does, ACC will participate openly in that process. ACC will
identify both the successes of the pilot as well as the areas where
improvements could be made to the pilot.
ACC's suggestions will focus more on how to make the pilot more
efficient, not how to build a whole new program with wholly different
objectives. It's important to be careful at this midpoint stage to
maintain the resolve of the volunteer sponsors to continue in the
program. Industry has lived up to its extensive commitments under this
program. A two year, multi-stakeholder process created this pilot, and
it is now only mid way through to completion. Although the VCCEP
program has not moved as quickly as we might have hoped, the pilot has
been an excellent test of tiered approaches to chemical evaluation,
integrating hazard and exposure information, and of the contributions
of independent scientists to EPA's own assessment of data needs.
__________
Statement of William K. Rawson, Partner and Chair of the Environment,
Land and Resources Department, Latham and Watkins
Mr. Chairman, distinguished members of the Committee and staff--
good morning. I would like to begin by thanking the Committee for
inviting me to testify today. I consider it a privilege to have this
opportunity to contribute to the public discourse on the Toxic
Substances Control Act (TSCA). This is an important subject, and I hope
that my comments will prove useful to the Committee.
I am a partner in the law firm of Latham & Watkins and chair its
environmental practice in Washington, DC. I have been with the firm
since 1982, and have practiced in the environmental area, with an
emphasis on chemical regulation under TSCA and other environmental
statutes, since 1987. I have co-authored a TSCA Deskbook published by
the Environmental Law Institute, and have been involved in numerous
rulemaking proceedings arising under various sections of TSCA. My
testimony is based on my experience representing and counseling
companies and trade associations on issues arising under TSCA and other
chemical regulation statutes over the last 19 years. However, the views
I will express today are solely my own.
TSCA section 2 states that it is the policy of the United States
that:
(1) Adequate data should be developed with respect the effect of
chemical substances and mixtures on health and the environment;
(2) Adequate authority should exist to regulate chemical substances
and mixtures which present an unreasonable risk of injury to health or
the environment; and
(3) Authority over chemical substances and mixtures should be
exercised in such a manner as not to impede unduly or create
unnecessary economic barriers to technological innovation while
fulfilling the primary purpose of this chapter to assure that such
innovation and commerce in such chemical substances and mixtures do not
present an unreasonable risk of injury to health or the environment.
The question before the Committee today is whether the provisions
of TSCA give EPA the authority it needs to achieve these objectives. I
believe the answer is ``yes.''
In my judgment, TSCA is a well-crafted statute that has stood the
test of time quite well.
scope of testimony
My testimony will focus on three sections of the statute:
Section 5 pertaining to review, testing and control of new
chemicals;
Section 4 pertaining to the testing of existing chemicals; and
Section 6 pertaining to the regulation of existing chemicals.
I will discuss whether the statutory language in each section is
appropriate and sufficient to enable EPA to perform its functions under
the Act. There are a number of issues concerning how EPA has
implemented each of these sections of TSCA; for the most part, I will
not discuss those implementation issues, except insofar as they are
relevant to assessing the adequacy of the statutory language. I do
believe EPA could improve its performance under TSCA by addressing some
of the implementation issues.
Also, it is important to understand that TSCA does not stand alone,
and actions taken by EPA under TSCA represent only a small part of the
total chemical management story in the United States. EPA regulates the
use, release and disposal of chemical substances under many other
environmental statutes. Other Federal agencies, including OSHA, FDA and
CPSC, also have substantial responsibility for ensuring the safe
manufacture and use of chemicals under their respective statutory
authorities.
Additionally, chemical manufacturers have adopted voluntary
initiatives and product stewardship programs to support the safe
manufacture and use of their products. Many of the industry's voluntary
initiatives have been undertaken in collaboration with EPA and other
stakeholders. Again, I will focus primarily on the language of the
statute, and defer to others to address the voluntary initiatives and
product stewardship efforts that help meet the objectives of TSCA.
This testimony assumes the reader is generally familiar with the
provisions of TSCA and EPA's principal accomplishments under each
section, as much of that information has been provided elsewhere.
Finally, I would like to express strong appreciation for EPA's
mission. I have worked closely with many EPA managers and staff over
the years on numerous challenging issues, and have great respect for
their efforts in support of EPA's mission.
section 5: new chemicals
The strength of section 5 of TSCA lies in its flexibility. The
provisions of section 5 recognize implicitly that industrial chemicals
are not all alike; some are readily determined to have low toxicity and
to be relatively innocuous, while others present significant toxicity
concerns that require close scrutiny before commercial manufacture is
allowed to commence. Section 5 gives EPA flexibility to vary its
assessments of new chemicals according to the attributes and expected
uses of each substance. In this way, EPA is able to ensure that the
introduction of new chemicals into commerce does not pose unreasonable
risks, without imposing undue economic burdens or unnecessary barriers
to innovation.
Many new chemicals qualify for complete or partial exemptions from
the premanufacture notice (PMN) requirements. Section 5 expressly
authorizes exemptions for substances manufactured or processed only in
small quantities solely for R&D, for substances manufactured or
processed for test marketing purposes, and for non-isolated
intermediates. Section 5(h)(4) also authorizes EPA to promulgate rules
exempting other categories of new chemical substances from all or part
of the PMN requirements, if the Agency has determined that the
substances ``will not present an unreasonable risk of injury to health
or the environment.''
EPA has used this authority to create additional partial exemptions
for polymers, chemicals that will be produced only in low volumes, and
chemicals for which the manufacturer is able to demonstrate low release
and exposure. EPA also has created exemptions for certain categories of
chemicals that are produced but have no separate commercial purpose,
such as impurities. Thus, section 5 gives EPA authority to streamline
the new chemical review process for categories of chemicals that can be
determined upfront not to pose unreasonable risks to health or the
environment. In this way, section 5 promotes the efficient use of EPA
resources, and also avoids imposing unnecessary burdens on industry.
Some new chemical substances do not qualify for an exemption, but
can readily be determined to pose little or no risk to health or the
environment based on information provided with the PMN, use of EPA
models, and comparison to other previously approved substances (using a
methodology known as structure activity relationship, or SAR). In fact,
according to EPA officials, the majority of new chemicals submitted for
review can be screened out as not requiring further review based on
screening models that show low potential for toxicity, or based on
other information (anticipated uses, potential for releases and
exposures) demonstrating low potential risks.\1\ Again, section 5
allows EPA the flexibility to make these judgments, and to adjust the
new chemical review process accordingly.
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\1\GAO, Chemical Regulation: Options Exist to Improve EPA's Ability
to Assess Health Risks and Manage Its Chemical Review Program, at 12
(June 2005) [hereinafter GAO Report].
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Many new chemical substances, however, do require close scrutiny
before they enter commerce. With regard to these substances, some
stakeholders have expressed a concern that there is no minimum base set
of tests that must be submitted with the PMN, to facilitate EPA review.
However, section 5 effectively gives EPA the authority to require the
PMN submitter to conduct the testing that EPA deems necessary in each
case to support a determination whether the manufacture or use of the
PMN substance will pose unreasonable risks. Thus, additional authority
is not necessary.
Specifically, section 5(e) gives EPA authority to prohibit or limit
the manufacture and use of any new chemical substance where: (1)
existing information is insufficient to permit a ``reasoned
evaluation'' of the substance's health and environmental effects; and
(2) either the substance may present an unreasonable risk of injury to
health or the environment, or the substance will be produced in
substantial quantities and there will or may be substantial human or
environmental exposure. EPA has used its authority under section 5(e)
to require testing of numerous PMN substances. EPA also has developed a
guidance document that identifies numerous chemical categories of
concern, and identifies the type of test data that typically will be
required for a PMN substance in each category.
In some cases, the PMN submitter has agreed to conduct the testing
during the PMN review process (by also agreeing to suspend the
statutory PMN review period during the conduct of the testing). In
other cases, the testing requirements have been incorporated into a
consent order issued under section 5(e). In either event, EPA has
received the information that it has deemed necessary to assess the
potential risks associated with the new chemical.
Additionally, EPA has authority under section 5(a) of TSCA to
promulgate a significant new use rule (SNUR) for a PMN substance, and
thereby to require a company to submit a significant new use notice
(SNUN) to EPA before engaging in uses identified in the SNUR. SNUNs
operate much like PMNs; they enable EPA to evaluate new uses of a
chemical substance before they are undertaken and decide whether such
uses should be subject to special regulations. EPA has used its SNUR
authority to codify the restrictions in section 5(e) orders so they
apply to subsequent manufacturers of the chemical, and also to control
the uses of existing, TSCA inventory-listed chemicals that raise
concern.
EPA's relatively recent use of SNURs in connection with the
voluntary phase-out of perfluoroalkyl sulfunate (PFAS) substances is a
good example of how EPA can use a SNUR to address hazards associated
with an Inventory-listed substance. In May 2000, the sole U.S.
manufacturer of perfluorooctanyl sulfunate (PFOS) announced it would
voluntarily withdraw production. The phase-out was completed in 2002.
Following this, the EPA issued a SNUR in March 2002 limiting any new
manufacturing or importing of 13 PFAS chemicals that were being
produced by 3M.\2\ In December 2002, the EPA issued a second SNUR
adding 75 additional chemicals, but excluding ``low volume, controlled
exposure uses in: semiconductor manufacture, aviation hydraulics, and
photography.''\3\ Thus, through close cooperation with industry and use
of its authority under section 5(a)(2), the EPA was able to extend the
voluntary phase-out by the sole manufacturer to all prospective
producers and importers of the subject compounds.
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\2\67 Fed. Reg. 11,014, 11,020 (Mar. 11, 2002) (Perfluoroalkyl
Sulfonates. Proposed Significant New Use Rule) (''EPA determined that
the proposed SNUR should be promulgated as final for the 13 chemicals,
employed principally in coatings for textiles, carpet, apparel,
leather, and paper, on which no comments were received and which 3M,
the sole manufacturer, confirmed were discontinued from manufacture
before Dec. 31, 2000.''). In the original proposed SNUR, these
chemicals were referred to collectively as perfluorooctylsulfonates, or
PFOS, but commenters noted that this generic usage of the term PFOS was
inconsistent with the use by the manufacturer of PFOS to refer only to
chemicals with an eight-carbon, or C8, chain length.
\3\Battelle, Overview: Office of Pollution Prevention and Toxics
Programs, at 18-19 (Dec. 24, 2003) [hereinafter Battelle Report]; see
also 67 Fed. Reg. 72,854, 72,859 (Dec. 9, 2002) (Perfluoroalkyl
Sulfonates; Significant New Use Rule).
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Also, under section 5(f) of TSCA, if EPA determines a new chemical
substance ``presents or will present an unreasonable risk of injury to
health or the environment before a rule promulgated under section 2605
[section 6] of this title can protect against such risk,'' the Agency
may issue a proposed rule under TSCA section 6(a) that is effective
upon its publication in the Federal Register, or alternatively may
issue an order or may apply for an injunction in Federal court to
prohibit the manufacture, processing, or distribution in commerce of
the substance.
As of September 30, 2002, EPA had taken the following actions:
Issued 1243 section 5(e) orders (500 with SNURs, and 743
without);
Promulgated an additional 437 non-section 5(e) SNURs; and
Taken four actions under section 5(f).
Further, 1552 PMNs had been withdrawn in the face of impending EPA
action. Thus, it is clear that EPA has exercised its authority under
section 5. to give careful scrutiny to new chemical substances where
appropriate. EPA in fact has imposed substantial controls or
effectively prohibited the manufacture of more than 3200 chemical
substances.\4\
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\4\Battelle Report, supra n.3, at 11.
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It is noteworthy that under section 5(e)(1)(C), a PMN submitter may
file objections with EPA to a proposed 5(e) order, and EPA is then
forced to go to court to obtain an injunction to prohibit or limit the
manufacture or use of the PMN substance (unless EPA determines that the
objections have merit and alters or withdraws the proposed order). To
my knowledge, no PMN submitter has ever forced EPA to go to court to
obtain such an injunction. In other words, no PMN submitter has ever
challenged a 5(e) order judicially; the PMN submitter has either
complied or withdrawn the PMN. This means in every case EPA's data
requirements and control requirements have been met, or the PMN has
been withdrawn.
PMN submitters have not always been pleased with EPA's proposed
testing requirements or control requirements. Some PMNs have been
withdrawn because the PMN submitter did not agree with the proposed
testing or control requirements, and the costs associated with those
requirements rendered commercialization impractical. But there has
never been a legal challenge. Thus, while there may be issues around
the edges pertaining to how EPA has implemented section 5 of TSCA,
there does not appear to be any basis for arguing that EPA lacks
authority to assess or regulate new chemical substances. To the
contrary, the provisions of section 5 appear well-designed to give EPA
the necessary flexibility and discretion to give each PMN substance the
level of scrutiny it merits, and to impose such restrictions on
manufacture and use as are necessary to prevent unreasonable risks to
health and the environment.
section 4: testing of existing chemicals
TSCA section 4 provides EPA with authority to impose health and
environmental effects testing requirements on chemical manufacturers
and processors. EPA has authority to require testing of existing
chemicals under two circumstances: when a chemical ``may present an
unreasonable risk'' (the 4(a)(1)(A) or ``A'' finding), or when a
cheMical ``is or will be produced in substantial quantities'' and
either ``enters or may reasonably be anticipated to enter the
environment in substantial quantities,'' or ``there is or may be
significant or substantial human exposure'' (the 4(a)(1)(B) or ``B''
finding). In each case, EPA also must show that (i) there is
insufficient data or experience to determine whether manufacture and
use pose unreasonable risks to health or the environment, and (ii)
testing is necessary to develop this data. Over the years, EPA has made
significant progress in developing testing programs for existing
chemicals and has issued detailed regulations governing development of
test rules, negotiation of enforceable testing consent agreements, and
compliance with testing requirements under test rules and consent
orders.
EPA has obtained test data for more than 200 substances under TSCA
section 4 test rules or enforceable consent agreements. Many more
chemicals have been screened for testing and determined by EPA or the
Interagency Testing Committee (ITC) to be low priority for testing or
not to require further testing, and testing of many more substances has
occurred on a voluntary basis without the need for a test rule. The
High Production Volume Challenge Program, which involved more than 2100
substances, is certainly a noteworthy example of a voluntary testing
initiative, but many individual substances also have been the subject
of voluntary testing that has made action under section 4 of TSCA
unnecessary.
There has been some suggestion that the findings required by
section 4 of TSCA are overly burdensome on EPA, and render section 4 an
ineffective vehicle for obtaining test data.\5\ I find these arguments
unpersuasive. The burden of proof that EPA must meet to support a test
rule in fact is quite modest under both the ``A'' finding and the ``B''
finding.
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\5\GAO Report, supra n.1, at 26.
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As already described, the statute only requires EPA to show that a
substance may present an unreasonable risk, or may reasonably be
anticipated to enter the environment in substantial quantities, or that
there is or may be significant or substantial human exposure. When
evaluating ``unreasonable risk'' under section 4, the EPA has stated
that its determination of whether a chemical ``may present'' a hazard
would not be based on definitive scientific data, but of necessity
would involve reasonable scientific assumptions, extrapolations and
interpolations.
The EPA has also stated that it is sufficient to show that exposure
may arise because of activities associated with the manufacture, use,
etc. of the chemical. The DC Circuit Court of Appeals endorsed the
Agency's contention that the mere potential for human exposure is
sufficient to support a ``may present an unreasonable risk'' finding
under section 4.\6\ The minimum burden that the court required was that
the EPA show the risk is ``a more-than-theoretical probability,'' and
the court said that EPA may demonstrate the potential for exposure
based on circumstantial evidence.\7\ Once the EPA has established this
``more-than-theoretical probability,'' the burden shifts to industry to
rebut this by presenting evidence to the contrary.
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\6\Chem. Mfrs. Ass'n v. EPA, 859 F.2d 977 (DC Cir. 1988).
\7\Id at 984-88.
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In 1990, industry challenged the cumene test rule which was based
on a ``B'' finding. The Fifth Circuit found the EPA's explanation of
the basis for its ``B'' finding inadequate and remanded.\8\ On remand,
EPA released the B Policy\9\ and applied it to the test rule that had
been challenged. No further legal challenge was pursued. (The court had
declined to stay testing, so testing had in fact already been
completed.) The B Policy establishes standards and criteria for making
``B'' findings. EPA defined substantial production as one million
pounds or more per year. EPA defined ``substantial'' human exposure
differently for three classes of people: workers (1,000 people),
consumers (10,000 people), or the general population (100,000 people).
EPA defined ``significant'' human exposure in terms of the nature of
the exposure (i.e., if the exposure is more direct than typical
exposure. Since then, these criteria have proven relatively easy to
apply).
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\8\Chem. Mfrs. Ass'n v. EPA, 899 F.2d 344 (5th Cir. 1990).
\9\EPA, TSCA Section 4(a)(1)(B) Final Statement of Policy: Criteria
for Evaluating Substantial Production, Substantial Release, and
Substantial or Significant Human Exposure, 58 Fed. Reg. 28,736 (May 14,
1993) [hereinafter, ``B Policy''].
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I do not agree with the suggestion that EPA should be permitted to
require testing based solely on a production volume trigger and a
determination that testing is necessary.\10\ Such an approach would
effectively negate consideration of potential exposure.\11\ EPA's B
Policy expressly recognizes that ``level, frequency, and duration of
exposure'' to a chemical should always be considered when determining
the sufficiency of existing data and the necessity of additional
testing.\12\ Eliminating consideration of the potential for human or
environmental exposure would make it marginally easier for EPA to
promulgate test rules, but it would not provide a more scientifically
sound basis for making testing decisions. Such a change also would not
be consistent with EPA's current policies and practices under TSCA
section 4.
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\10\GAO Report, supra n.1, at 27.
\11\EPA has recognized on many occasions that production volume is
not a surrogate for exposure or even potential exposure.
\12\B Policy, supra n. 9, at 28,742.
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I do believe EPA could improve its performance under TSCA section 4
in a number of ways. EPA has issued few test rules in recent years
(perhaps because substantial resources have been devoted to the HPV
Challenge Program), and some testing proposals have languished
unfinished for many years. Some suggestions for improvement include:
More timely responses to industry alternative testing proposals. I
have worked with numerous chemical industry groups that have submitted
alternative testing proposals to EPA in response to testing proposals
issued under TSCA section 4. The testing proposals have been intended
to meet EPA's objectives in a more cost-effective manner, sometimes by
making greater use of existing studies. EPA has sometimes taken as much
as two years to respond to such proposals. More timely responses would
help improve EPA's track record under section 4.
More flexibility in testing approaches. Perhaps because of the time
and expense associated with the development of proposed test rules, EPA
at times has not seemed open to alternative approaches. I have worked
with chemical industry groups that have proposed that EPA permit
testing to proceed in phases, such that the companies would conduct a
portion of the proposed testing initially, and then ask EPA to
reconsider, based on the results of the initial testing, whether the
balance of the proposed testing was still necessary. These proposals
have all been rejected (sometimes after an extended period of delay).
In these cases, I believe more flexibility on the part of the Agency
would have allowed testing on the subject chemicals to commence in a
reasonable and cost-effective manner, without compromising the Agency's
ability to obtain the test data that it deemed necessary.
I believe following the foregoing suggestions would lead to better
testing decisions, and would improve EPA's track record under section
4. However, I do not believe the statutory criteria need to be
modified. I believe the criteria in the statute provide a sound basis
for making scientifically appropriate testing decisions.
There have been very few legal challenges to test rules promulgated
under section 4. Indeed, there has been relatively little litigation
under TSCA generally, especially compared to the steady drumbeat of
litigation under other environmental statutes, such as the Clean Air
Act. The few legal challenges under TSCA section 4 have generally
affirmed EPA's broad authority to require testing.
section 6: regulation of existing chemicals
Section 6(a) of TSCA gives EPA authority to regulate the
manufacture, processing, distribution, use or disposal of a chemical if
the Agency has a ``reasonable basis'' to believe the chemical
``presents or will present an unreasonable risk to health or the
environment.'' Section 6 enumerates various regulatory options--from an
outright ban to warning and labeling requirements--and provides that
EPA may impose one or more of the enumerated requirements ``to the
extent necessary to protect adequately against such risk using the
least burdensome requirements'' (emphasis added).
When promulgating rules under section 6, EPA must take into account
the health and environmental effects of the substance, the magnitude of
exposure, the benefits of the substance, the availability of
substitutes, and the reasonably ascertainable economic consequences of
the proposed rule. A rule promulgated under section 6 must be supported
by ``substantial evidence'' in the rulemaking record considered as a
whole. Before EPA can regulate under section 6(a), the Agency also must
determine whether the problem could be better addressed by EPA or
another agency under another statute.
EPA's ability to regulate effectively under TSCA section 6 has been
called into question over the years because of the Fifth Circuit's
decision in Corrosion Proof Fittings v. EPA,\13\ which overturned a ban
on certain asbestos-containing products. If EPA cannot ban asbestos,
the argument goes, then what can it ban? The Government Accountability
Office (GAO) has suggested ways that the legal requirements of section
6 might be loosened, ostensibly to make EPA's job easier.\14\ However,
as will be demonstrated below, the failures in the asbestos rulemaking
were failures in implementation, and not caused by deficiencies in the
statute.
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\13\947 F.2d 1201 (5th Cir. 1991).
\14\GAO Report, supra n.l, at 34.
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EPA regulated several substances under section 6(a) during the
early years of TSCA. Starting in 1978, EPA used section 6(a) to ban
nonessential uses of fully halogenated chlorofluoroalkanes, which were
used primarily as propellants for aerosols. In 1980, EPA issued a rule
regulating disposal of wastes containing TCDD, a form of dioxin. In
1990, EPA issued a final rule prohibiting the use of hexavalent
chromium-based water treatment chemicals in comfort cooling towers. In
1984, EPA issued three immediately effective proposed rules under
section 6(a) to address unreasonable risks identified during the review
of PMNs. The three chemical substances affected by the rules were
intended for use in metalworking fluids, and EPA was concerned that the
addition of certain nitrosating agents could lead to the formation of a
substance shown to be carcinogenic in animals. Accordingly, EPA banned
the use of nitrosating agents in metalworking fluids containing the PMN
substances. EPA used its authority under section 5(0(2) to make the
proposed rules under section 6(a) effective immediately.
EPA was not as successful with its attempt to regulate asbestos.
EPA's asbestos rule under section 6 was promulgated in 1989 and banned
most uses of asbestos still in commerce, including asbestos-containing
floor materials, clothing, roofing and other building materials,
pipeline wrap, friction products (e.g. brakes), and other automotive
products. EPA also banned all new uses of asbestos, and all existing
uses that were not currently in production in the United States
In handing down its decision in Corrosion Proof Fittings, the court
upheld EPA's determination to proceed under section 6, instead of
deferring to other Federal agencies under TSCA section 9. The court
also upheld EPA's ban on products not being produced in the United
States currently, and the ban on unknown, future uses of asbestos.
Concerning the bans on existing asbestos-containing products, the court
articulated a ``presumption of validity'' in favor of EPA's rule, and
rejected a number of arguments advanced by industry petitioners
challenging the bans. However, the court found such fundamental errors
in EPA's methodology and rationale for banning asbestos-containing
products that all product-specific bans were struck down in their
entirety. The asbestos rule and the court's decision are described more
fully in an attachment to this testimony. A few of the Agency's errors
are highlighted in the following paragraphs.
Inadequate notice of a key element of EPA's analysis. EPA used
``analogous exposure'' data--exposure data obtained under comparable
circumstances to the circumstances being addressed--to calculate
expected benefits of the asbestos bans. The court found that for some
products, use of the analogous exposure estimates constituted the bulk
of EPA's analysis,\15\ and in some cases the analogous exposure
analysis ``completely altered the EPA's calculus and multiplied four-
or five-fold the anticipated benefits.''\16\ Yet EPA did not disclose
that it was relying on ``analogous exposure'' data until after the
hearings were closed.
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\15\Corrosion Proof Fittings, 947 F.2d at 1212.
\16\Id. at 1213 n.11.
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Failure to justify not pursuing less burdensome alternatives. The
Court found EPA gave inadequate consideration of less burdensome
alternatives. EPA did give some consideration to labeling asbestos
products and stricter workplace rules. However, the court found EPA's
analysis inadequate, because EPA ``rejected calculating how many lives
a less burdensome regulation would save, and at what cost.''\17\ EPA
failed to consider adequately the less burdensome options because it
believed there was no level of asbestos exposure that would pose zero
risk. However, as the court correctly noted, ``Reducing risk to zero. .
. was not the task that Congress set for the EPA in enacting
TSCA.''\18\ EPA misconstrued its authority under section 6--aiming for
zero risk instead of eliminating ``unreasonable risk''--and as a result
failed to address adequately the statutory requirement that it employ
the least burdensome alternative necessary to protect against
unreasonable risks.
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\17\Id. at 1216.
\18\Id. at 1217.
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The court's opinion should not be construed to require a
quantitative assessment of the costs and benefits of every regulatory
option, starting with the least burdensome, in every section 6
rulemaking. In other successful section 6 rulemakings, EPA has
considered and rejected less burdensome alternatives without
undertaking such a quantitative analysis.
Inflated Estimates of Benefits. When calculating the workplace
benefits of the bans, the court found that did not consider currently
available control technologies that could have provided improved
workplace conditions. Additionally, the court criticized EPA's method
of calculating the present value of future health benefits, which the
court believed inflated potential health benefits from the product
bans.
Failure to Consider Harm From Use of Substitutes. In the case of
asbestos-containing friction products (primarily replacement drum and
disk brakes),\19\ which accounted for ``the lion's share of the
proposed benefits of the asbestos regulation,'' a study commissioned by
EPA raised significant concerns about the effectiveness and potential
health risks of substitute products. One of the study authors testified
that the ``replacement/substitution of asbestos-based with non-asbestos
brake linings will produce grave risks,'' and that 'the expected
increase of skid-related highway accidents and resultant traffic deaths
would certainly be expected to overshadow any potential health-related
benefits of fiber substitution.''\20\ Further, many of the EPA's own
witnesses conceded on cross-examination that the non-asbestos fibrous
substitutes would pose cancer risks upon inhalation. Ultimately, the
court concluded that ``a death is a death, whether occasioned by
asbestos or by a toxic substitute product.''\21\ EPA could not ignore
the risks and possible toxic effects of the proposed substitutes for
asbestos once the potential concerns were brought to the Agency's
attention.
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\19\Notably, the court's opinion related to after-Market brakes and
the difficulty of installing non-asbestos replacement brakes in
vehicles designed to use asbestos brakes. At the time, most new cars
were engineered for non-asbestos brakes.
\20\Id. at 1224 n.25 (citing written testimony).
\21\Id. at 1221.
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Other equally significant errors are noted in the court's opinion.
It is apparent that the asbestos rule did not fail because of the
requirements of section 6. As the court stated in its conclusion, EPA's
product-specific bans were rejected because of ``the agency's reliance
upon flawed methodology and its failure to consider factors and
alternatives that TSCA explicitly requires it to consider.'' One gets
the impression, from reading the opinion, that the court was deeply
troubled by the number of ways the reasoning in the final rule was
skewed in favor of its proposed outcome, as reflected by the court's
repeated references to ``flawed methodology'' and ``cursory,''
``cavalier'' and ``meaningless'' treatment of data. I say this not to
be critical of EPA, but because it is important that the court's
decision not be misunderstood.
The lesson that should be learned from Corrosion Proof Fittings is
not that section 6 cannot work. The lesson is that no matter what the
product, when acting under section 6, EPA must consider all relevant
information, conduct proper procedures, and present a reasonable basis
for its decision.
the gao recommendations
``Least Burdensome Requirements'' test. GAO has suggested that
TSCA section 6 might be amended to eliminate the requirement to
demonstrate that the regulatory option chosen is the ``least burdensome
requirement'' necessary to address the identified health or
environmental risks. However, before EPA bans the use of a product, it
is not unreasonable to require the Agency to show that there is no less
burdensome alternative that would be sufficient to protect human health
and the environment. Stated differently, if there is a less burdensome
alternative that would be adequately protective of human health and the
environment, there would seem to be no justification for not using it,
and no justification for banning a product that has proven to be
valuable in commerce. Further, notwithstanding the result in Corrosion
Proof Fittings, if EPA determines that a ban is the least burdensome
requirement, the Agency should not be concerned that its judgments will
be easily second-guessed by the courts. To the contrary, if regulations
imposed under section 6 are based on consideration of the relevant
factors, adequately explained and promulgated through proper
procedures, they will receive deferential treatment by courts.\22\ EPA
made the ``least burdensome requirement'' determination successfully in
each of its other section 6(a) final rules.
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\22\Corrosion Proof Fittings, 947 F.2d at 1214 (citing Envtl.
Defense Fund v. EPA, 636 F.2d 1267, 1277 (DC Cir. 1980) (``Under the
substantial evidence standard, a reviewing court must give careful
scrutiny to agency findings and, at the same time, accord appropriate
deference to administrative decisions that are based on agency
experience and expertise.''')).
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``Unreasonable Risk'' standard. GAO also has suggested that section
6 might be amended to replace the requirement to demonstrate an
``unreasonable risk'' with a requirement to show a ``significant
risk.'' GAO indicates that finding ``significant risk'' would require
EPA to show that the ``risks are substantial or serious.'' Moving from
``unreasonable'' to ``significant'' risk, however, would be
inconsistent with several other provisions of TSCA, which also use the
phrase ``unreasonable risk'' and clearly reflect congressional intent
that EPA consider health and environmental impacts and social and
economic impacts when regulating under TSCA.\23\ This congressional
intent is stated explicitly in section 2(c): ``[i]t is the intent of
Congress that the Administrator shall carry out this chapter in a
reasonable and prudent manner, and that the Administrator shall
consider the environmental, economic, and social impact of any action
the Administrator takes or proposes to take under this chapter.''\24\
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\23\See, e.g., sections 4(a) (testing authority for existing
chemicals); 5(e) (allowing regulation of new chemicals pending
development of information); and 5(t) (allowing immediate regulation to
prevent against unreasonable risk).
\24\15 U.S.C. 2601(c).
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The ``unreasonable risk'' standard requires a balancing of the
nature of the potential harm being addressed, the probability of the
harm occurring, and the harm that would result from the rule. Thus,
full consideration is given to the nature of the potential adverse
health or environmental effects being addressed, and the likelihood of
that harm occurring. To suggest, however, that EPA might consider
imposing a ban on valuable commercial products without any
consideration of the potential social or economic impacts of the ban
clearly is not consistent with congressional intent for how EPA should
implement its authority under TSCA. The asbestos rule, in fact,
demonstrates the importance of considering the potential impacts of any
product ban, given that there was credible evidence, supported by an
EPA-sponsored study and EPA witnesses, that the ban on asbestos brakes
for after-market use could cost more lives than it was projected to
save.
TSCA is by no means unusual in requiring EPA to consider potential
social and economic impacts of its regulatory actions. For example, the
Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) requires EPA
to consider ``any unreasonable risk to man or the environment'' and
take ``into account the economic, social, and environmental costs and
benefits of the use of any pesticide.'' Pesticides are subject to very
rigorous scrutiny, perhaps more so than any other category of products,
and to my knowledge the ``unreasonable risk'' standard has not
prevented EPA from exercising its authority in a prudent and health-
protective manner.
In short, GAO's suggestion that the ``unreasonable risk'' standard
in section 6 be replaced with a ``significant risk'' standard would be
inconsistent with other provisions of TSCA and contrary to clear
congressional intent, and also is not necessary to protect human health
or the environment.
``Presents or Will Present'' Test. GAO also suggested that section
6 might be amended to require that EPA demonstrate only that a chemical
``may present'' an unreasonable risk, rather than requiring a
demonstration that a chemical ``presents or will present'' an
unreasonable risk. However, experience under section 4 of TSCA does not
support this recommendation. Under that section, EPA has authority to
require testing of a chemical that ``may present an unreasonable risk''
to health or the environment. As described earlier in this testimony,
the ``may present'' standard has proven to be a very low threshold, and
requires only a ``more-than-theoretical basis for suspecting that some
amount of exposure takes place,''\25\ and hazard information that
supports merely a suspicion of toxicity.\26\ Such a low standard may be
entirely appropriate within the context of section 4, where EPA is
deciding whether additional data should be collected. However, such a
low standard would be inappropriate under section 6, where the Agency
has the ability to ban a chemical. Moreover, if the ``may present''
standard were incorporated into section 6, it would be possible for the
Agency to skip the testing step and proceed directly to a ban merely on
the suspicion of a hazard and a ``more-than-theoretical basis'' for
believing that exposure might be occurring, rendering section 4
meaningless.
---------------------------------------------------------------------------
\25\Chem. Manuf. Ass'n v. EPA , 859 F.2d at 984.
\26\45 Fed. Reg. 48,524, 48,528 (July 18, 1980) (Chloromethane and
Chlorinated Benzenes Proposed Test Rule; Amendment to Proposed Health
Effects Standards) (''EPA's conclusion that the chemical may present a
hazard will not be based on definitive scientific data. This is
inevitable; if EPA knew in detail the types of hazards a chemical
posed, there would be no need to test. Thus, determinations of hazard
potential under Section 4 by their very nature must involve reasonable
scientific assumptions, extrapolations, and interpolations.'').
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conclusions about section 6
There has been a tendency among critics of TSCA to judge EPA by the
number of chemicals that have been banned under section 6. I believe
that is an unduly narrow way of looking at EPA's accomplishments --
under section 6 and under TSCA generally.
The EPA took a unique, but instructive approach in a case where
they proposed a rule to prohibit the manufacture, distribution, and use
of acrylamide grout to protect workers from exposure to acrylamide and
another chemical. After eleven years, the proposal was withdrawn
because the development of personal protective equipment (PPEs) made
the rule unnecessary. A lower cost alternative was available to protect
workers from exposure to the acrylamide and other chemicals in these
grouts.\27\ Since EPA's concerns were addressed, this action should be
considered a success, notwithstanding that no ban was implemented.
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\27\For more details, see Battelle Report, supra n.3, at 21.
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Also, as noted earlier in this testimony, EPA has used it authority
under section 5(a)(2) to issue SNURs as another way to address concerns
related to Inventory-listed substances. The PFAS case described earlier
is just one example; there are many others.
Thus, section 6 is not the only mechanism for addressing
unreasonable risks. Good product stewardship is a much more efficient
approach and is the first line of defense. It is important that EPA
have a means to address unreasonable risks when necessary, and section
6 as it is currently designed does provide that authority, but the
industry must continue to act responsibly and the EPA, when it takes
action, must do so within the statutory guidelines laid out in section
6.
In sum, I believe EPA can regulate effectively under TSCA section 6
as it is currently written, as evidenced by EPA's successes during the
first decade after TSCA was enacted. EPA's asbestos rule was struck
down because in that case, EPA used flawed methodology and failed to
consider relevant factors, not because of problems with section 6
itself. GAO's suggested revisions of section 6 are not necessary, in my
judgment, to support effective regulation, and would not improve the
statutory framework for making regulatory decisions. I believe the
language of section 6 provides a sound basis for EPA decision-making,
and does not impose unreasonable burdens on the Agency. To the
contrary, it highlights the key factors that should be considered by
EPA when contemplating whether to ban or restrict the use of products.
conclusion
Thank you for giving me the opportunity to testify today. In my
judgment, TSCA is a well- crafted statute and provides the EPA ample
authority to achieve the objectives set forth in the statute. EPA has
accomplished a great deal over the years under TSCA (including under
section 8, though not discussed in this testimony). I believe EPA could
accomplish even more through improved implementation, but I do not
believe revisions to the statute are necessary. I hope you find this
testimony helpful in your deliberations.
______
Responses by William K. Rawson to Additional Questions
from Senator Inhofe
Question 1a. Is it true that EPA must demonstrate an actual risk
before it can issue an order, regulate or prevent a new chemical from
being introduced? Section 5(e) says that EPA must demonstrate that a
chemical ``may present'' a risk.
Response. EPA does not have to demonstrate an actual risk before
regulating a chemical under section 5(e). That section gives EPA
authority to prohibit or limit the manufacture and use of any new
chemical substance where: (1) existing information is insufficient to
permit a ``reasoned evaluation'' of the substance's health and
environmental effects; and (2) either the substance may present an
unreasonable risk of injury to health or the environment, or the
substance will be produced in substantial quantities and there will or
may be substantial human or environmental exposure. Thus, EPA may act
under section 5(e) based on information showing only that a new
chemical substance ``may present'' a risk, or information showing that
there will or ``may be'' substantial human or environmental exposure.
Question 1b. Is that too high a bar?
Response. No. In my judgment, the findings that are required are
quite reasonable, and this conclusion is supported by the fact that EPA
has made those findings and used its authority to regulate chemicals
under section 5(e) on numerous occasions. Indeed, as described in my
written testimony, EPA has imposed substantial controls or effectively
prohibited the manufacture of more than 3200 chemical substances. This
number includes more than 1500 premanufacture notices (PMNs) that have
been withdrawn in the face of impending EPA action.
It is possible that fewer PMNs may be withdrawn in the future,
because EPA has developed a guidance document that identifies numerous
chemical categories of concern, and identifies the type of test data
that typically will be required for a PMN substance in each category.
This means that industry now has a better understanding than it did
when TSCA was enacted concerning EPA's views about which types of
chemicals are likely to present the greatest concerns. The result is
that fewer PMNs may be submitted for some categories of chemicals. In
this way, EPA's implementation of TSCA is having an impact in many
cases without a PMN ever being filed.
Additionally, as is described in my testimony, a PMN submitter may
file objections with EPA to a proposed 5(e) order, and EPA is then
forced to go to court to obtain an injunction to prohibit or limit the
manufacture or use of the PMN substance. To my knowledge, no PMN
submitter has ever forced EPA to go to court to obtain such an
injunction. In other words, no PMN submitter has ever challenged a 5(e)
order judicially; the PMN submitter in every case has either complied
or withdrawn the PMN. This means in every case EPA's data requirements
and control requirements have been met, or the PMN has been withdrawn.
Question 2a. Why not require a base set of testing for each new
chemical for which a PMN is submitted?
Response. Commercial chemicals are not all alike. Any base set of
testing that might be chosen would be too much for some new chemicals,
and not enough for others. Under the current approach, EPA is able to
get the data it needs for each chemical, based on EPA's scientific
judgments in each case. As described in my testimony, the majority of
new chemicals in fact either qualify for an exemption from PMN
requirements, or are relatively easily screened out based on
information provided in the PMN. Requiring the development of
additional test data for these substances would serve no useful
purpose, and in fact would be counter-productive, because it would clog
the new chemical review system and consume substantial EPA resources
reviewing the data submissions.
It is important to understand that the PMN submitter has an
incentive to provide whatever data EPA requests --whether that consists
of a ``base set'' of testing or something greater. That is the only way
to get to market. There may be discussion back and forth with the
Agency concerning what data are really needed, but at the end of the
day, the PMN submitter must meet EPA's data requirements to get to
market. Stated differently, if a chemical has made it to market, that
means the PMN submitter has met EPA's data requirements and
demonstrated to EPA's satisfaction that there will be no unreasonable
risks to health or the environment.
As stated in my testimony, the strength of section 5 of TSCA lies
in its flexibility. EPA is given discretion to vary its assessments and
testing requirements for new chemicals according to the attributes and
expected uses of each substance. This flexibility promotes the
efficient use of EPA resources and avoids imposing unnecessary burdens
on industry, while giving EPA the authority it needs to ensure that the
introduction of new chemicals into commerce does not pose unreasonable
risks. I am not aware of any evidence that EPA has exercised its
discretion in a way that has led to inadequate review or inadequate
control of new substances. I see no justification for taking that
flexibility away by prescribing a base set of testing that must be
performed for all new substances, whether needed or not.
There has been some suggestion that commercial chemicals regulated
under TSCA should be held to the testing standards applied to
pesticides under FIFRA. Dr. Goldman in her written testimony refers to
the ``reasonable certainty of no harm'' standard applied to food use
pesticides (but not other pesticide products), and she suggests that
such a standard should be applied to commercial chemicals under TSCA.
However, pesticides are very different from commercial chemicals
regulated under TSCA, because all pesticides are designed to be
biologically active--to kill pests or invasive plants. They also are
intentionally released into the environment, and many are used on our
food supply. It typically takes more than ten years and tens of
millions of dollars to conduct required testing and bring a new
pesticide active ingredient to market, and the burden on EPA resources
who must review all the data submissions are enormous. EPA typically
takes more than three years to review a new active ingredient for which
a pesticide registration is sought.
It would be completely impractical to take such an approach with
all commercial chemicals, and EPA's experience under section 5 shows
that it is not necessary. As noted in my testimony, commercial
chemicals vary widely in their attributes and potential uses and
exposures, and the vast majority of chemicals qualify for an exemption
or are readily determined not to pose unreasonable risks. Thus, a
FIFRA-like approach to new (or existing) chemicals under TSCA is both
unnecessary and would have a severe adverse impact on chemical
innovation.
Dr. Goldman also asserts that ``TSCA does not require the
protection of sensitive populations, including children.'' That is not
a correct statement. TSCA requires EPA to protect against unreasonable
risks to human health, and that includes children and other potentially
sensitive subpopulations. The suggestion that EPA managers and staff
don't consider risks to children absent an explicit mandate from
Congress is not fair to EPA managers and staff, nor is it supported in
any way by past experience. Test rules promulgated under TSCA section 4
have consistently included testing aimed specifically at chemical risks
to children, and EPA chemical assessments always encompass all relevant
(i.e., potentially exposed) populations. EPA's IRIS assessments
(described further below), for example, explicitly are intended to
identify exposure levels that can continue for a lifetime without
appreciable risk to the general population, including sensitive
subgroups, including children. EPA takes the same approach under TSCA.
Question 2b. Do you consider EPA's use of models to review new
chemicals adequate?
Response. Yes. We are well beyond the age when every chemical must
be tested separately. EPA has gained a lot of experience reviewing
chemicals during the first 30 years of TSCA, and its current use of
models and SAR (structure activity relationships) is efficient and also
health protective. Any research or study that might be done to improve
on models is good, but I believe EPA's current use of models is
effective and scientifically appropriate. I have seen no evidence to
the contrary.
It is important to recognize that models of all kinds are typically
applied by EPA in a conservative fashion, meaning that hazards,
exposures and/or risks are likely to be overestimated, not under-
estimated. This is true under TSCA but also other environmental
statutes. Such an approach is inherently health protective, and it also
gives industry an incentive to collect chemical-specific data if they
believe true risks are likely to be lower than risks estimated through
the use of models.
Question 3a. Why hasn't EPA tested more than 200 or so chemicals
under section 4?
Response. Focusing on the number of chemicals that have been the
subject of test rules or consent orders under TSCA section 4 is
misleading for several reasons. First, a much larger number of
chemicals have been screened for testing by EPA or the Interagency
Testing Committee (ITC) and determined to be low priority for testing
or not to require further testing at all. Second, testing of many more
substances has occurred on a voluntary basis without the need for a
test rule or consent order. The High Production Volume (HPV) Challenge
Program, which involved more than 2100 substances, is one obvious
example that has been described in written testimony. Third, industry
over the years has conducted a large volume of testing on its own,
without the need for any action under TSCA section 4 or any structured
voluntary program. Thus, focusing on the number of chemicals subject to
formal action under section 4 does not give an accurate picture of the
number of substances that have been tested over the years, or the
amount of test data that is available.
By way of example, EPA maintains a publicly-available Integrated
Risk Information System (IRIS) which includes toxicity assessments of
various commercially important substances. EPA does not include a
substance in the database unless there is sufficient test data to
support such an assessment, and each assessment typically includes a
determination of a safe daily exposure (oral, inhalation or both) that
may be repeated for a lifetime without appreciable risk to the general
population, including children. There currently are more than 500
compounds in the IRIS database. The toxicity assessments for some
compounds run fifty to a hundred pages, and include citations to
hundreds of studies. Moreover, it well-known that there are many more
substances for which similar amounts of data are available but that
have not yet been included in the IRIS database, simply because it
takes time to do so.
Thus, testing that has been conducted under TSCA represents a small
fraction of the toxicity information available to support assessments
of commercial substances. This is as it should be, because industry has
always conducted a substantial amount of testing on its own initiative,
including before TSCA was enacted, and of course a large volume of
testing is conducted every year by non-industry researchers as well.
Question 3b. Do you think the requirements of section 4 are the
reason EPA has not required more testing? In other words, do you think
the findings required by the statute are an impediment to testing?
Response. No. The statute requires EPA to show that a substance may
present an unreasonable risk (the ``A'' finding), or that it may
reasonably be anticipated to enter the environment in substantial
quantities, or that there is or may be significant or substantial human
exposure (the ``B'' finding).
Thus, the burden of proof that EPA must meet to support a test rule
in fact is quite modest under both the ``A'' finding and the ``B''
finding. Moreover, in practice EPA has set very low thresholds for
making these findings, and EPA's approaches have largely been upheld in
the few reported court decisions, as described in my testimony.
Dr. Goldman asserts that ``the analytic burden required of EPA to
write TSCA 4 Test Rules and to defend them from litigation has resulted
in a situation such that, repeatedly, over the past two decades, the
Government Accountability Office (GAO), the Congress, and others have
noted a lack of productivity and the absence of a clear agenda for
testing.'' I would like to make three points in response to this
statement. First, these assessments by GAO and others fail to recognize
the large body of testing that has been conducted outside TSCA (see
discussion above). Second, Dr. Goldman does not point to any particular
aspect of the ``analytic burden'' that is a problem. In reality, as
shown above, the statutory findings that are required are quite modest,
and if applied correctly, the statutory criteria are well-designed to
support sound testing decisions. Third, while legal challenges are not
uncommon when an agency implements a new program, in fact there have
been very few legal challenges to TSCA test rules, and the decisions of
the courts have affirmed EPA's broad discretion to require testing.
Thus, the implication that a litigation threat has impaired chemical
testing programs is not accurate.
I also do not agree with the GAO's suggestion that EPA should be
permitted to require testing based solely on a production volume
trigger and a determination that testing is necessary. Such an approach
would effectively negate consideration of potential exposure. (EPA has
repeatedly recognized that production volume is not a surrogate for
exposure information.) EPA's B Policy expressly recognizes that
``level, frequency, and duration of exposure'' to a chemical should
always be considered when determining the sufficiency of existing data
and the necessity of additional testing. Eliminating consideration of
the potential for human or environmental exposure would make it
marginally easier for EPA to promulgate test rules, but it would not
provide a more scientifically sound basis for making testing decisions.
Such a change also would not be consistent with EPA's current policies
and practices under TSCA section 4.
I do believe that EPA could improve its performance under TSCA
section 4, and have offered some suggestions in my testimony, but I do
not believe the findings required by section 4 are the problem, and I
do not believe amendments to section 4 are necessary to meet the
objectives of the statute.
______
Response by William K. Rawson to an Additional Questions
from Senator Jeffords
Question 1. Mr. Rawson, it is my understanding that other countries
require chemical companies to provide basic chemical data on new
chemicals to regulators. In addition, the European Union is about to
require that chemical companies provide similar data on chemicals
already in commerce. Shouldn't chemical companies provide similar
information to EPA?
Response. Respectfully, I believe EPA is already getting the
information it needs for new and existing chemicals, including
information well beyond ``basic chemical data'' in many cases.
Accordingly, I believe the suggestion that a basic data set be
required by statute in the United States for all new and existing
chemicals is not necessary.
For the reasons expressed above and in my written testimony, I
believe EPA currently has ample authority under TSCA sections 4 and 5
to require chemical manufacturers to conduct testing and submit
information sufficient to support sound safety assessments of new and
existing chemicals. The amount of information that is required will
vary from one chemical to the next (whether new or existing), and that
is entirely appropriate, because chemicals vary widely in their
physical properties, chemical structures, environmental persistence,
potential to bioaccumulate, potential toxicities, expected uses, and
potential exposures. For many chemicals, EPA has collected data that
far exceeds what might be considered ``basic chemical data.'' In other
cases, EPA will decide that very little additional information is
required, beyond what typically is supplied with a PMN, as happens with
many new chemicals under section 5.
No new chemical can get to market without meeting EPA's data
requirements, so there is no ``data gap'' for new chemicals. If
something less than a ``base set'' of data was required to support a
PMN, then something less than a base set of data was sufficient to meet
EPA's requirements. That obviously will be the case for any chemical
that qualifies for an exemption from the PMN filing requirements, and
there are many such chemicals.
Under the HPV Challenge Program, EPA now has a base set of
screening data for more than 2100 HPV chemicals, so the goal of a base
screening set also largely already has been met for the vast majority
of existing chemicals that are in commerce in significant volumes.
Importantly, this program allowed for exercise of sound scientific
judgment, such as the grouping of substances by relevant categories, so
that separate testing of each chemical could be avoided where such
individual testing was not scientifically necessary. Such chemical
groupings obviously avoid the unnecessary use of laboratory animals,
but they also save on EPA resources that otherwise would be expended
reviewing redundant test data, and they allow testing programs to be
completed more efficiently and in less time. The HPV program has been
extended in a voluntary industry effort on new HPV chemicals identified
in the 2002 TSCA inventory, and also to add exposure information to
hazard information that has already been collected. Thus, through this
voluntary program and other testing that has occurred over the years,
EPA and U.S. industry have largely already out-performed any
requirement to generate a base set of test data for existing chemicals.
I do not think it would be wise for Congress to replace the current
flexible approach with a statutory ``one-size fits all'' approach for
all new or existing chemicals. Any such prescriptive approach is
certain to miss the target more often than it hits the target, because
commercial chemicals vary so widely, as already described. Moreover, it
would be difficult in such a prescriptive approach to address issues
such as the one described in the preceding paragraph, pertaining to
when chemicals can be tested by group, rather than individually. Those
kinds of decisions cannot be made by statute, but require scientific
judgment applied to the facts of each case. EPA must have the
flexibility to avoid unnecessary testing and the unnecessary use of
laboratory animals.
__________
Statement of Lynn R. Goldman, Professor, Environment Health Sciences,
John Hopkins University, Bloomberg School of Public Health
Mr. Chairman and members of the Committee on Environment and Public
Works, it is my honor to testify today about the Toxic Substances
Control Act.
I am a pediatrician and a professor of environmental health at the
Johns Hopkins Bloomberg School of Public Health. I also serve as chair
of the Board for the Children's Environmental Health Network and member
of the Board of Trustees of Environmental Defense. From 1993-98, I
served as Assistant Administrator for Prevention, Pesticides and Toxic
Substances at the U.S. Environmental Protection Agency (EPA). While
serving in that position I was responsible for the implementation of
the Toxic Substances Control Act. Prior to joining the EPA I worked for
eight years in public health with the California Department of Health
Services. However, my testimony represents my own views and not the
views of these other organizations.
When TSCA was passed in 1976, there were great expectations that it
would improve our understanding of chemical risks and address these
risks in a comprehensive multi-media framework. But, for a variety of
reasons, TSCA has not been able to fully live up to these expectations.
It is ironic, then, that TSCA has not been the subject of significant
legislative action since its passage. In fact, TSCA is probably the EPA
statute that has seen the least change in the last 30 years. The people
in the Toxics program at the EPA do an excellent job with the tools
that they have but they have neither the legislative tools nor the
resources that are needed. There are several symptoms that all is not
well with TSCA. First is the rising tide of chemicals being regulated
on a State-by-State basis. While I support the right of states to take
action to protect their citizenry only Federal actions protect all U.S.
citizens. Second is the enormous gap that is forming between TSCA and
the new chemicals legislation (REACH) in the European Union. And third
is the dwindling away of personnel and resources in the EPA devoted to
core TSCA efforts.
Today, I will focus on a discussion of a number of areas of concern
--and opportunity for change. These include: risk evaluation,
protection of vulnerable populations, risk management, precaution, new
chemicals, right to know, pollution prevention, international
management of chemicals and priority-setting.
risk evaluation
To evaluate risk requires the availability of data on hazards and
exposures. The Chemical Testing Program was established to carry out
the policy expressed in TSCA that adequate data should be developed
with respect to the health and environmental effects of chemical
substances and that the development of these data should be the
responsibility of chemical manufacturers and processors. Unfortunately
the analytic burden required of EPA to write TSCA 4 Test Rules and to
defend them from litigation has resulted in a situation such that,
repeatedly, over the past two decades, the Government Accountability
Office (GAO), the Congress, and others have noted a lack of
productivity and the absence of a clear agenda for testing. EPA has
tried to overcome this problem in a number of ways, including: use of
Enforceable Consent Agreements rather than test rules; development of a
Master Testing List and voluntary approaches for
screening high volume chemicals in cooperation with the chemicals
industry and the OECD (Organization for Economic Cooperation and
Development). These voluntary programs are good programs but it is not
at all clear how and when EPA will move from screening to more
extensive testing of chemicals for adverse endpoints.
Another important information gathering provision is TSCA Section
8(e), a critically important information-gathering tool that serves as
an ``early warning'' mechanism for keeping the Agency apprised of
significant new chemical hazards and exposures, and for satisfying the
public's right to know about these hazards. EPA's longstanding policy
has been, appropriately, that if certain serious health effects are
discovered, that information should be considered for immediate
reporting to EPA without further evaluation. Over and over again,
across the decades, it comes to pass that companies may misinterpret
TSCA Section 8(e) and EPA's corresponding policy. EPA has tried to
remedy this situation in several ways including by providing guidance
documents and via the voluntary Compliance Audit Program (CAP) which,
in 1992, allowed participating companies to submit delinquent Section
8(e) information and pay stipulated penalties up to a $1 million
ceiling. Yet, this problem has recurred again and again. Some recent
examples of significant information being withheld from EPA include:
chromium, diacetyl and PFOA.
EPA collects little to no information about chemical exposures yet
such information is essential to the evaluation of risk. TSCA needs to
be reformed to give EPA clear expectation for testing of risks of
existing chemicals. TSCA also needs to provide for exposure monitoring,
by EPA or in collaboration with others such as the CDC. The structure
of TSCA should reward companies for the generation of information about
chemicals and exposures, through more rapid approvals and/or avoidance
of penalties.
protection of vulnerable populations
TSCA does not require the protection of sensitive populations,
including children. Several other statutes, the Clean Air Act, the Safe
Drinking Water Act and the Food Quality Protection Act all contain
provisions making it clear that such populations should be protected.
Children are often more highly extesed to chemicals in the environment,
via diet, inhalation, crawling on the floor, mouthing hands and objects
in the environment, and route such as transfer from other to baby in
utero or in breast milk. Children are often more susceptible. ``Windows
of exposure'' during development cause susceptibly to irreversible
effects like birth defects, neurobehavioral outcomes, and other
developmental alterations, and cancer. Parents are not aware that the
products in their homes are made with chemicals, many of which have not
been assessed at all for risks to children (or even adults). Because
the fetus and child are often more exposed and can be more susceptible
to adverse effects of chemicals during critical life stages, this is a
particularly important vulnerable group. Other groups include people
who have genetic differences in response or metabolism of chemicals;
the elderly, and people with preexisting conditions. TSCA should
explicitly require the protection of vulnerable populations. Exposure
and response patterns of vulnerable populations should be
included in risk analyses for chemicals and additional uncertainty
factors employed where such information is both missing and relevant.
risk management
In terms of managing the risks of toxic chemicals, the EPA never
has recovered from the Fifth Circuit Court of Appeals decision to
remand the 1989 Asbestos Ban and Phaseout Rule to EPA. In this case,
the court's decision imposed a burden of proof on EPA that
significantly increased the level of analysis on potential substitutes
and on identifying the least burdensome approach for any future Section
6 action. Second, the court's interpretation of least burdensome
alternative under Section 6 appears to define end-of-pipe solutions,
where toxic substances are controlled after they are distributed into
the environment, as less burdensome than pollution prevention
solutions, where toxic substances are reduced or eliminated at their
source. End-of-pipe solutions are in conflict with the pollution
prevention approach and are more costly over time. EPA needs for
Congress to restore its ability to take regulatory action to manage
risks of chemicals. Strengthening EPA's ability to manage chemicals
risks is this is the single most effective way that Congress could turn
the tide on State-by-State regulatory actions on chemicals.
precaution
Decisions about chemical risks should be made based on a stronger,
more health based safety standard or goal. The current safety standard
is to avoid ``unreasonable risk to health or the environment'', which
means that decisions are based on risk benefit balancing. The standard
for pesticides in food is one of a ``reasonable certainty of no harm''.
This is a public health standard. Such a standard is needed for
chemicals to which we are exposed in our daily lives, just as it is
needed to protect us from residues of pesticides in food. Additionally,
existing chemicals on the market should be reviewed to assure that they
are safe. Certain categories of chemicals, such as persistent chemicals
should be given highest priority (as has been done by Canada). Such a
precautionary approach would tend to shift the ``burden of proof' onto
manufacturers, to prove that chemicals are safe rather than on EPA to
prove that they are unsafe. Such an approach is in contrast the ``least
burdensome'' provision of current law, which made the banning of
asbestos impossible.
new chemicals
Section 5 of TSCA requires that anyone who intends to manufacture
or import a new chemical substance in the United States notify EPA 90
days before commencing that activity. The EPA new chemicals program has
over the years reviewed thousands of new chemical substances. In many
cases EPA has made decisions to prevent risk before a harmful substance
enters commerce. The United States' new chemicals program is unique in
that it requires review of chemicals prior to manufacture rather than
prior to marketing as in most other countries with such systems. I
think that there is general agreement among the chemicals regulators
worldwide that what would make more sense is a system that gives
different types of approvals for R&D and for marketing chemicals. This
would help the EPA focus more efficiently on the chemicals which are
actually destined for the market. In the case of TSCA, the thousands of
chemicals that are submitted and the 90-day review period are
challenging. On top of that, the new chemicals program in the United
States does not require any testing prior to PMN submission and
therefore over half of all PMNs are submitted without any test data.
Ever resourceful, the Agency has developed tools to use Structure
Activity Relationships (SAR) to predict and assess the fate and effects
of new chemicals. Other systems, most notably the ``pre-REACH'' Pre-
marketing Notification scheme used in the European Union (EU), require
a ``base set'' of testing on new chemicals. In the 1990s the United
States and EU evaluated the utility of SAR and found that it worked for
some endpoints but not others, particularly a number of chronic health
effects.
When EPA determines that there is a risk associated with a PMN it
has tools that can be used to manage those risks. TSCA Section 5 gives
EPA the ability to require additional tests or other measures such as
disposal controls and worker protection. Over the years, the new
chemicals program has made wonderful efforts to inform the chemical
industry about the criteria used to assess chemicals. These efforts
have encouraged development of safer chemicals, and I believe have
caused the industry to screen out ``bad actors'' before presenting them
to the EPA in the first instance.
TSCA's new chemical provisions would be improved if EPAs effort
were focused premarket rather than premanufacture approvals and would
benefit greatly from the addition of risk related data to the agency's
determinations.
right to know
Empowering the public with information is a powerful tool for
environmental progress. The creation of the Toxics Release Inventory
(TRI), established in Section 313 of the Emergency Planning and
Community Right-to-Know (EPCRA), led the way to a new era of public
disclosure and a more constructive dialogue between citizens and
industry on emissions reduction and pollution prevention. For a toxic
chemicals program, it is almost inevitable that the ``right to know''
ethic will expand to other chemical information. The public release of
environmental data gives everyone the ability to participate in the
broader national effort to set a toxics agenda and address chemical
issues based on the extent of risk posed. The states, local
Governments, industry, labor unions, public interest groups and grass-
roots community groups are increasingly finding ways to work together
on environmental improvements. All problems of chemical management
cannot be solved through direct EPA action. As one example of this, the
EPA has unsuccessfully attempted to foster and enhance the
participation of individual states in chemical management by providing
them with TSCA derived chemical data. As a former State regulator, I
know the value of site specific information in risk assessment and
priority setting. Yet, the language of the law has been interpreted to
say that such information cannot be shared with State officials if it
has been declared as ``confidential business information''. In relation
to this problem, there is a large amount of information reported to the
EPA under TSCA information claimed as confidential business
information; studies have found that much of which does not deserve
such protection.
EPA has attempted to reform the CBI process but such efforts have
foundered on resource limitations and the language of the law, which
gives manufacturers too much leeway. Some examples from a survey of the
data conducted by EPA in 1998:
In 1998, more than 65 percent of the information filings directed
to the Agency through TSCA were claimed as confidential.
Submissions under the former Inventory Update Rule show that
about 20 percent of facility identities were claimed as confidential.
In 1998, 40 percent of Section 8(e) substantial risk notices had
chemical identity claimed as confidential.
There is a need to reform the CBI provisions in TSCA. Also Congress
needs to rethink the role of the states, which has expanded greatly
since 1976, and identify ways to provide them not only with more
information but also with more opportunities to participate in
chemicals management efforts
pollution prevention
Preventing pollution offers significant opportunities for
protecting the environment and public health in a cost effective
manner. The adoption of a pollution prevention ethic is a logical
development in a toxic chemicals program, given the focus on improving
environmental protection through changes in the manufacture, processing
and use of chemicals in our society. Fundamentally, we need to
encourage use of safer chemicals and processes in our industrial
sector. In order to achieve this TSCA would need to be altered in a
number of fundamental ways. First, EPA needs stronger coordination
among its ``media'' offices when it comes to chemicals to prevent the
movement of harmful substances from air to water to waste. Second, TSCA
does not reward the development of newer safer alternatives. Newer
chemicals are reviewed more carefully than existing ones and the lack
of regulation of hazardous existing chemicals does not create an
incentive to remove them from the market. Congress needs to examine
ways to create incentives for greener chemicals and chemical use
patterns. TSCA should support and reward companies for research and
development and for creating safer substitutes through tools such as
exemptions and more rapid approvals for market. TSCA should be a tool
to break down the ``silos'' at EPA to assure that chemicals are managed
properly from cradle to grave and not inappropriately shifted from one
medium to another (for example, from water to air).
international management of chemicals
Increasingly it is recognized that a number of very persistent and/
or very hazardous chemicals need to be managed globally. In 1992 the
Rio Conference adopted Agenda 21, which contained a number of goals for
international management of toxic substances. Since that time we have
seen the development of many new institutions including: the
InterGovernmental Forum on Chemical Safety, a global treaty on prior
informed consent for the import of highly toxic chemicals (the
Rotterdam convention or PIC) and the global treaty on Persistent
Organic Pollutants (POPs). Yet the United States has been slow to join
these issues and in fact has not ratified the POPs and PIC conventions.
A ``clean'' approach to ratification is needed so that the United
States can fully participate in these important efforts to protect the
health of the global community.
priority setting
Because there are so many chemicals on the market that have yet to
be evaluated, what is needed is for Congress to set a clear agenda for
priorities in evaluation and management of chemicals, as well as clear
expectations for action. Some factors that might be considered include:
Children's exposure pathways and uses that are likely to expose
children
Biomonitoring and environmental data; which chemicals are in
peoples bodies
Cancer, developmental, reproductive and ecological effects and
chemicals classes associated with such effects
Higher production volumes
Bioaccumulative or environmental persistence properties
Use patterns; chemicals uses more likely to result in exposures
to humans and the environment
conclusion
In summary, overhaul of TSCA is long overdue. The Kids Safe
Chemicals Act of 2005 is an effort that takes the debate in the right
direction. EPA needs clear requirements and regulatory authority that
requires placing a high priority on protecting health (especially for
vulnerable populations) and the environment. Minus congressional action
on TSCA we will continue to see the erosion of Federal management of
chemicals on many levels. We will see more states taking action to
manage chemicals, thereby creating confusion in the markets and unequal
levels of protection State by State. We also will continue to see the
dwindling down of activities on the Federal level with a commensurate
increase in the risk that ``bad actors'' will get through the net. And
we will increasingly see the European Union and others move into the
lead in this area, thus putting us at a competitive disadvantage. This
is a complicated area but at the end of the day there is one simple
principle that should be kept foremost, which is assuring the American
public that the products on the market, the air they breathe, the food
and the water, are safe.
______
Responses by Lynn R. Goldman to Additional Questions
from Senator Inhofe
Question 1. Doctor Goldman, during the hearing we had an exchange
about animal testing in which you suggested that there were other
methods besides animal testing that might be utilized to determine
health effects of chemicals. Can you provide specific examples of types
of testing that does [sic] not involve animals or humans? How do these
tests differ from modeling?
Response. Senator Inhofe, there are a variety of ways to generate
data that provide information about toxicity of chemicals. Given the
vast numbers of chemicals that need to be assessed, it makes sense to
employ a tiered testing framework. The framework which was developed by
the EPA along with stakeholders in the Endocrine Disruptor Screening
and Testing (EDST) Advisory Committee (which I chaired 1996-98)
provides an illustration of how such an approach can work to utilize
methods besides animal testing in a logical fashion-(Figure 1).
Although this framework was developed for the detection of health
effects related to endocrine disruption, 1 believe that the general
concept of a tiered approach that we developed for the EDST framework
can very logically be extended to other types of toxicity to human
health and the environment. Moreover, this framework was supported by
scientists from various disciplines as well as by all of the involved
stakeholder groups.
[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]
The way that such a tiered approach can work is that initially
chemicals can be sorted and some chemicals can be removed from further
consideration on the basis of unlikelihood of exposure (the boxes
labeled ``polymers'' and ``exempted'' chemicals), very low to no
production volume, or having already been assessed. Such chemicals can
initially be prioritized using information such as chemical structure,
physical properties, structure activity relationships (SAR). production
volume, conditions of use, permitted uses, and existing toxicology
studies; no new animal studies would be required at this stage. Of
these tests, only one (SAR) involves the use of modeling. For endocrine
disruption it was determined that a cutoff for ``high'' production
volume would be >10,000 lbs/year, far lower than the one million lb
cutoff for the HPV program. Under the EDST program such chemicals would
be subjected to high throughput prescreening (HTPS) tests; these are in
vitro tests that use cell-culture based assays (but not animals or SAR
models) to provide a further indicator of whether a chemical is a
priority for further assessment. For the EDST program at this point
chemicals can be judged low priority, can go directly to hazard
assessment, or can be prioritized for Tier 1 screening or Tier 2
testing. Tier 1 screening involves 13 tests, six of which are in vitro
(and therefore do not use animals), two of which use nonmammalian
species (tadpoles and fish), and two of which use smaller numbers of
animals than conventional tests. Again, after Tier 1 screening
chemicals are prioritized for whether or not any further action is
needed, and, if so, if that would involve hazard assessment or
proceeding to Tier 2 testing. All five of the tests in Tier 2 involve
the use of animals, however only one uses mammals (rats) and the others
use, respectively, Japanese quail, frogs, fish and an invertebrate
called mysid shrimp. Using nonmammalian species is not only more humane
but also assures that the chemicals with the greatest potential for
hazard are tested in species that are of economic and ecological
importance to humankind, such as fish, birds and shrimp and/or most
sensitive to ecological damage, such as frogs. In any case, by using a
tiered approach the chemicals that wind up in Tier 2 are those for
which the value of information is highest, thus (in my view) more
clearly justifying the use of animals.
This example illustrates how much information potentially can be
made available prior to requiring testing and that it is possible to
focus the use of animal tests only on the chemicals that are most
likely to be ``bad actors''. This example was for endocrine disruptors
because the 1996 Food Quality Protection and Safe Drinking Water Acts
required that EPA develop such a screening and testing program.
However, the basic approach could be applied much more generally and
with appropriate legal authority the Federal Government could inform us
about risks to a much greater extent than we are today.
Question 2. Assuming that some types of biological effects
information can only be gleaned by testing on biological specimens,
i.e. animals. Do you have any concerns about [sic].
Response. At this time there are indeed biological responses that
can be assessed only via testing on whole biological systems, animals.
At the same time, knowledge is rapidly advancing and new scientific
approaches under development in the areas of genomics, proteomics, and
metabolomics perhaps some day will lead to the development of testing
technologies that can replace animal testing, in whole or in part. Even
today, in vitro testing can be used to rapidly screen and assess
chemicals and to determine which chemicals are a higher priority for
further testing, and which are not.
Given how slowly we have made progress to assess risks of chemicals
I am concerned that some might invoke concerns about testing on animals
to justify our failure to assess the toxicity of most chemicals to
which we, and our children, are exposed. At the same time that we take
steps to develop new strategies to minimize use of animals and to find
ways to assess hazards of novel substances like products of
nanotechnology, we also need to increase our knowledge about the
hazards of chemicals in our environment. These efforts can go hand in
hand. Any new alternative methods must be consistent with sound
scientific practices necessary to obtain valid results, while
addressing the ``3 R's'', reduction, refinement, and replacement, of
alternatives to animals testing. Reduction involves development of
methods that reduce the number of animals required for a test method.
Refinement involves development of methods that lessen or eliminate
pain or distress in animals or enhance animal well-being. Replacement
involves development of methods that replace animals with non-animal
systems or replace an animal species with a phylogenetically lower
species (for example, replacing mammals with fish or invertebrates).
The process of assessing and validating new test protocols is
complicated and requires the input of scientists from many disciplines
including toxicology, statistics, exposure sciences and basic sciences
such as molecular biology.
______
Responses by Lynn R. Goldman to Additional Questions
from Senator Jeffords
Question 1. TSCA's Lack of Protections for Children Ms. Goldman,
please describe some of the concerns that you have regarding EPA's
ability to use TSCA to protect the health of vulnerable individuals,
including children?
Response. In brief, the Toxic substances Control Act (TSCA)
contains no provision for special consideration of risks to children
and other vulnerable populations. We know that, at various life stages,
children are more exposed to chemicals that occur in drinking water, in
certain foods, in air, in dust and dirt and in certain products such as
toys. They may have slower --or faster metabolism or elimination of
substances during various developmental stages. We also know that
during fetal and early childhood development there is the potential for
irreversible harm to occur, via mechanisms birth defects, adverse
impacts on the developing brain or growth, immune system effects and
increased cancer risk. The law should require that the EPA consider the
juncture between exposure and vulnerability during the development of a
child. In addition, there are many other vulnerable individuals in the
population: people with increased risk on a genetic basis; the elderly;
and those who are severely ill and/or immunocompromised. Some
suggestions are:
Clear requirements that EPA place a high priority on protecting
children's health and on protecting other vulnerable subpopulations.
A strong safety standard, such as a ``reasonable certainty of no
harm''
Health protection of children is the basis for chemical
regulatory decisions.
An additional safety margin for children, pregnant women, the
fetus, nursing women, and women of child-bearing age
Recognition of and protection for children most at risk,
including children of lower socioeconomic status, children of racial
and ethnic minority status, children with special health care needs,
and children whose parents have occupational exposure to chemicals.
Establishment of protocols for data collection, hazard and
exposure assessments that explicitly consider children and their most
sensitive and vulnerable health effects.
Consideration of multiple and synergistic effects of different
chemicals, of chemicals with multiple pathways of exposure, and of
chemical mixtures.
Question 2. Potential reforms to TSCA Ms. Goldman, please describe
the aspects of TSCA that you would change in order to ensure that EPA
has the legal authority to quickly stop exposure to dangerous chemical
substances and to prevent such exposures, while conserving limited
public resources.
Response. First, to assure that children are adequately protected,
I think that TSCA needs to be reformed in order to include:
Clear requirements that EPA place a high priority on protecting
children's health and on protecting other vulnerable subpopulations.
A strong safety standard, such as a ``reasonable certainty of no
harm''
Health protection of children is the basis for chemical
regulatory decisions and these decisions are based on active processes
of review of information..
An additional safety margin for children, pregnant women, the
fetus, nursing women, and women of child-bearing age
Recognition of and protection for children most at risk,
including children of lower socioeconomic status, children of racial
and ethnic minority status, children with special health care needs,
and children whose parents have occupational exposure to chemicals.
Establishment of protocols for data collection, hazard and
exposure assessments that explicitly consider children and their most
sensitive and vulnerable health effects.
Consideration of multiple and synergistic effects of different
chemicals, of chemicals with multiple pathways of exposure, and of
chemical mixtures.
Second, to strengthen the EPA's ability to protect the public from
harmful chemicals, TSCA should be reformed to..
Not allow exposure to chemicals that do not meet core information
requirements.
Assure commitment to timeliness, and that protective measures are
adopted by default if action is not taken on a timely basis.
Reward the generation of information about chemicals and
exposures.
Support and reward for research, development and innovation that
produces safer substitutes.
Assure collection of; biomonitoring data under appropriate
scientific guidelines.
Require periodic review of chemicals, with more frequent review
of more hazardous materials.
Include strong enforcement provisions including routine
inspections and random audits of testing facilities and laboratories.
Give citizens the ability to file suit and to petition EPA for
action on toxics.
Increase the public's ``right to know'' by reform of TSCA's
overly broad confidential business information provisions
Third, to conserve limited public resources, TSCA should be
reformed to:
Shift the burden of proof such that the onus is on industry is to
demonstrate safety of a chemical by supplying required data.
Provide a tiered approach to the assessment of chemicals in
commerce.
Strengthen participation by State (and sometimes local)
Government which often can act more efficiently and in a more targeted
fashion than the Federal Government.
Strengthen role of other Federal agencies including NIEHS, NTP,
and CDC, in biomonitoring and in assessment of hazards of chemicals.
Promote the ``three R's'' (reduction, refinement and replacement)
to reduce the burden of animal testing.
Promote international cooperation in the management of chemicals
in commerce internationally
Assure a transition that includes a process for establishing
priorities for review and approval of existing chemicals. Priority is
to be given to ``the worst first''--after consideration of children's
exposures, biomonitoring data, developmental neurotoxicity, disparate
impacts on certain populations, intrinsic properties (such as
bioaccumulative or environmental persistence), use patterns, and
production volume.
Assure a fair and predictable process that provides clear
expectations for industry and predictable outcomes of assessment and
review, so that private resources are not wasted as well.
impact of applying protections for children in tsca
Question 3. Ms. Goldman, Congress has included protections for
children and other vulnerable populations in numerous public health and
environmental laws, including the Safe Drinking Water Act, Clean Air
Act and the Federal Food, Drug and Cosmetic Act.
Please describe the range of benefits that you believe would occur
if Congress included similar provisions in TSCA.
Response. The benefits are likely to be quite large. According to a
study done by Mt. Sinai university, for the United States alone:
``Total annual costs are estimated to be $54.9 billion (range $48.8-
64.8 billion): $43.4 billion for lead poisoning, $2.0 billion for
asthma, $0.3 billion for childhood cancer, and $9.2 billion for
neurobehavioral disorders. This sum amounts to 2.8 percent of total
U.S. health care costs.''
Of these, I would expect that $9.5 billion each year (the costs
attributed to childhood cancer and neurobehavioral disorders) could
potentially be saved. This amount would increase substantially were one
to add in costs attributed to exposures to susceptible adult
populations as well as a number of costs that they were not able to
assess, including costs of pain and suffering and late complications
that are not yet well understood. [1]
limitations of current protections for children's toys
Question 4. Ms. Goldman, please describe the limitations of other
Federal agencies' regulations to protect children's health from toxic
substances in children's toys. In particular, please describe the
critical role that EPA regulation could play in filling gaps in the
regulatory scheme of other Federal agencies, such as the Consumer
Product Safety Commission.
Toys are regulated by the Consumer Products Safety Commission
(CPSC) under the Federal Hazardous Substances Act. If you go to their
webpage and you will find pages and pages of toy product recalls.
However, almost all are for the (very important) goal of protecting
children from injuries, such as aspiration, choking, and strangulation
by toys. Except in the case of lead, there is little to no action
related to chemicals in toys, even though Congress has given CPSC the
authority to recall toys for reason of chemical risk. CPSC does not
even regulate chemicals in pacifiers, children's products with great
likelihood of exposure. Instead, CPSC relies on voluntary efforts to
achieve such protection (such as addressing hazards from nitrosamine or
phthalates in pacifiers). In its defense, CPSC does not have adequate
staffing and resources to address the thousands of chemicals that are
in children's products. Although the drafters of TSCA envisioned a
coordinated process between EPA and the other regulatory agencies in
reality the process by which EPA is to ``refer'' chemicals to other
agencies does not function well. The EPA needs to be able to directly
take action when it has evidence that chemicals in children's products
are a health risk.
__________
Statement of Michael P. Wilson, Ph.D, M.p.h,
University of California, Berkeley
Mr. Chairman and members of the committee, thank you very much for
inviting me to the hearing today on chemicals policy and the Toxic
Substances Control Act. I am Michael Wilson, an assistant research
scientist with the Center for Occupational and Environmental Health at
the University of California, Berkeley and the lead author of a report
regarding chemical problems in California and the steps the California
Legislature can take to respond to those problems. I will speak briefly
about the report, entitled Green Chemistry in California: A Framework
for Leadership in Chemicals Policy and Innovation, which was published
by the University of California in March of this year. I would like to
acknowledge co-authors Daniel Chia and Bryan Ehlers and the Advisory
Committee of experts that provided technical guidance and rigorous
review of the document over a two-year period.
The report responds to three questions posed to the University by
the California Legislature:
What are the key chemical challenges facing California?
What are the causes of those challenges?
How might the Legislature respond to those challenges?
In answering these questions, we found that California, like other
States, is facing an array of problems with chemicals. These problems
are experienced in different ways by the businesses in our State that
purchase and use chemicals, by our Government agencies, and by
consumers and workers. But three themes emerged out of our
investigation. First, there is insufficient information in the
marketplace to make informed decisions abut chemicals. Second,
Government is overly constrained in its capacity to protect public and
environmental health from chemicals.
And third, more needs to be done to motivate investment in safer
chemical technologies, known as ``green chemistry.''
While the focus of the report is on the challenges that exist in
California, the report finds that the root cause of these challenges
can be traced to longstanding deficiencies in Federal regulation,
particularly with the Toxic Substances Control Act, or TSCA. The report
illustrates that the weaknesses of TSCA have produced a Data Gap, a
Safety Gap, and a Technology Gap in the U.S. chemicals market. I would
like to briefly explain these three Gaps and their relevance to
chemicals policy in the United States
The first of these, the Data Gap, is perhaps the most fundamental.
As you have heard from other witnesses, TSCA does not require chemical
producers (United States or foreign) to generate and disclose robust
information on the toxicity of the vast majority of chemicals in
commercial circulation. Markets cannot function without good
information, and the chemicals market is no different. We found that
California businesses that use chemicals are unable to identify and
choose the safest chemicals for their needs. This leaves them with
uncertainties and liabilities arising from the potential effects of
these chemicals on their workers, on their customers, and in the
environment. Even large firms, such as those in California's
electronics industry, are finding it very difficult and expensive to
identify and replace hazardous chemicals in their supply chains. These
firms simply do not have the right kind information to identify safer
chemical alternatives. Of course, small business owners, workers, and
consumers are affected even more acutely by the lack of appropriate
information in the chemicals market.
This pervasive lack of information also poses a barrier to the
competitive advantage of innovative companies that are investing in
green chemistry. In the current chemicals market, customers, investors
and others are unable to efficiently differentiate between conventional
chemicals and safer alternatives. The report finds that green chemistry
will become commercially viable only when the market allows these
entities to make informed purchasing decisions. It is one of the proper
roles of Government to ensure that the market has sufficient
information to function properly, and in this regard, TSCA has come up
short.
The second challenge recognized in the report is the Safety Gap. It
is also a proper function of Government to ensure that the production
and use of goods does not come at the expense of public and
environmental health. Here again, TSCA has fallen short. It is well
recognized that U.S. EPA has been greatly constrained in it ability to
assess the hazards of chemicals in commercial circulation and to
control those of greatest concern. This has allowed hazardous chemicals
to remain competitive in the market, and it has unnecessarily put the
public at risk. It is also costly. For example, the EPA expects that if
production and regulatory practices remain the same, 600 new hazardous
waste sites will appear in the United States each month of every year
over the next 25 years; clean-up costs are estimated at over $250
billion. The CDC reports that about half of the top 50 chemicals at
existing waste sites can cause birth defects; others are toxic to the
human nervous system.
Other social costs of chemical exposures are more subtle. There is
evidence that hundreds of chemicals are accumulating in the human body.
Some of these --including flame retardants, wood preservatives, and
stain repellants --have been identified in the umbilical cord blood of
newborn babies. Of course, the effects of chemical exposures during the
uniquely sensitive period of human development are of great concern.
Furthermore, chemical exposures in the workplace continue to produce a
substantial burden of occupational disease in the United States. In
California, about 23,000 workers each year are diagnosed with chronic
diseases that are attributable to chemical exposures on the job. The
Safety Gap created by TSCA is allowing real problems to continue
unchecked, problems that will likely expand as global chemical
production doubles over the next 25 years.
Together, the Data Gap and Safety Gap are contributing to stagnant
conditions in the U.S. chemicals market. This is producing what we
characterize in the report as a U.S. chemical Technology Gap. Only 248
new chemicals introduced since 1979 have reached High Production Volume
status in the United States, about 8 percent of the High Production
Volume chemicals in commercial circulation today. In its 1996 Vision
2020 report, the U.S.-based Council for Chemical Research, together
with the American Chemical Society, the American Institute of Chemical
Engineers, the American Chemistry Council, and the Synthetic Organic
Chemical Manufacturers Association, wrote that the vast majority of
chemical products are manufactured in the United States using
technologies developed 40 to 50 years ago and that new technologies are
needed that incorporate economical and environmentally safer processes,
use less energy, and produce fewer harmful byproducts. Ten years after
the Vision 2020 report, the websites of the 50 largest U.S. chemical
companies all contain a statement of commitment to achieving
sustainability goals, but their spending on research and development
has decreased or remained flat since 2000, according to the National
Science Foundation.
It is not surprising, therefore, that the Committee on Grand
Challenges for Sustainability in the Chemical Industry, convened by the
National Academy of Sciences, concluded in its December 2005 report
that in ``going forward, the chemical industry is faced with a major
conundrum--the need to be sustainable (balanced economically,
environmentally, and socially in order to not undermine the natural
systems on which it depends)--and a lack of a more coordinated effort
to generate the science and technology to make it all possible.'' The
committee included academic scientists as well as representatives of
Dow, PPG Industries, ConocoPhillips, and Agraquest.
The U.S. private sector is simply not investing vigorously enough
in cleaner technologies, such as green chemistry, that are likely to
mark the next era of innovation and growth in the global chemicals
market. It is a reflection of the current State of the chemicals market
(and the Technology Gap in particular) that with very few exceptions
one can still earn a Ph.D. in chemistry at U.S. universities without
demonstrating even a rudimentary understanding of how chemicals affect
human health and the environment. U.S. chemistry graduate students are
not required to gain an understanding of the principles of toxicology.
This is a serious problem not only for public and environmental health
but for the long-term competitiveness of the U.S. chemical industry
itself, as noted last year by the NAS Grand Challenges committee.
So what is to be done? First, our report acknowledges that the U.S.
chemical industry generates important benefits for society in the form
of an extraordinary array of substances serving all sectors of the
economy. At the same time, our report finds increasing evidence that
many of these substances can adversely affect human health and disrupt
the biological systems on which life itself depends. This is precisely
what makes chemicals policy so difficult. Some of the properties that
make chemicals useful to society also make them hazardous to people.
Once we acknowledge this paradox, however, we can begin to think about
how to re-design the production and regulatory systems so that they
amplify the positive contributions of chemicals to society while
steadily reducing their negative impacts. This represents a system that
is founded on the principles of green chemistry. It essentially
introduces the toxicity of chemicals into the market on an equal
footing with price and function, and in doing so it moves the market
steadily toward the design, production, and use of chemicals that are
inherently safer for people and ecological systems.
In short, a fundamental overhaul of the Federal Toxic Substances
Control Act is needed. A modern U.S. chemicals policy will need to put
in place the market conditions that advance the technical and
commercial viability of green chemistry. These new market conditions
will begin to motivate the chemical industry to focus its enormous
talent and technical capacity on innovating green chemistry at a level
commensurate with the scale and pace of chemical production. It will
open new market opportunities for green chemistry entrepreneurs. It
will not, however, be achieved through voluntary initiatives by the
industry, nor will it be achieved by piecemeal approaches to chemicals
policy, or by providing occasional funding to universities to conduct
green chemistry research. While these can help identify best practices,
for example, they are not sufficient --even collectively --to correct
the uneven playing field in the chemicals market that has been
engendered by TSCA. The UC report recommends that correcting these
market flaws will require a comprehensive approach to chemicals policy
that closes the Data Gap, the Safety Gap and the Technology Gap.
This is the key challenge of chemicals policy for California and
the nation, and I think it is reasonable to conclude that it is a
fairly formidable challenge. Meeting this challenge, however, will
deliver real value to the American people. It will build the foundation
for an economically and environmentally sustainable chemical industry
in the United States; it will solve a host of costly chemical problems
that are affecting public health, businesses, and Government; and it
will support our industry leaders in becoming globally competitive in
green chemistry and other cleaner technologies.
Mr. Chairman and members of the Committee, thank you very much for
your attention today, and thank you again for inviting me to this
important hearing. I would be pleased to answer any question you might
have.
______
Response by Michael P. Wilson to an Additional Question
from Senator Inhofe
Question 1. Does the UC report advocate the adoption of a reach-
like approach?
the uc report does not call for the adoption of a reach-like approach
in the u.s.
Response. The UC report proposes three overarching goals for
chemicals policy in California: Close the Data Gap, the Safety Gap, and
the Technology Gap. It then describes a number of issues that are
important for policymakers to consider with respect to each of these
goals (Chapter 7). The Data Gap refers to the lack of information in
the market on the safety of chemicals. The Safety Gap refers to the
barriers that Government faces in its efforts to assess the hazards of
chemicals and control those of greatest concern. The Technology Gap
refers to the potential for the United States to fall behind globally
in the science, technology, and commercial applicability of green
chemistry.
We developed these three policy goals (Chapter 3) based on
discussions with chemicals policy stakeholders in the United States, on
our participation in 35 chemicals policy meetings and conferences in
the United States (Appendix A), and in studying reports published by
the National Academy of Sciences (1984),\1\ the U.S. General Accounting
Office (1994),\2\ the Congressional Office of Technology Assessment
(1995),\3\ Environmental Defense (1997),\4\ the U.S. EPA (1998), the
U.S. Government Accountability Office (2005), former EPA officials, and
academic researchers. These reports all point to deficiencies in the
U.S. Toxic Substances Control Act (TSCA) that have prevented the
statute from serving as an effective vehicle for Government, industry,
consumers, and workers in the United States to assess chemicals in
commercial circulation and control those of greatest concern. The UC
report uses the terms Data Gap, Safety Gap, and Technology Gap to
describe the set of conditions in the United States that have emerged
as a consequence of these deficiencies.
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\1\Sensitive physiological processes can be disrupted during the
rapid growth and development characteristic of embryonic and fetal life
and the first year following birth. Development of the brain, for
example, requires the formation and interconnection of billions of
neurological cells; development of the endocrine system and
reproductive organs is guided by a precisely timed sequence of hormones
that exert their effects in the parts-per-trillion range.
\2\Children's metabolic pathways, especially in fetal life and in
the first month after birth, are immature. Among other factors, growth
of the blood-brain barrier, which can provide protection against some
chemicals, is incomplete during fetal and early child development, such
that chemicals are able to move directly from the maternal blood stream
into the developing fetal brain.
\3\Relative to their size, children's intake of air, water, and
food is far greater than that of adults. The amount of air a resting
infant breathes, for example, is twice that of an adult, normalized by
body weight. Children therefore experience disproportionately higher
doses of environmental agents, including chemicals.
\4\Children have more years of future life than adults and thus
have more time to develop diseases initiated by exposures early in
life. Many chronic diseases, including cancer and neurodegenerative
diseases, appear to arise as a result of cellular changes that take
place many years before the actual manifestation of the disease.
Critical windows of exposure to hazardous chemicals in utero, during
early child development, and during puberty are more likely to produce
chronic disease than similar exposures encountered later.
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the uc report describes reach as the e.u.'s strategy to address a set
of chemicals policy problems that are essentially identical to those of
the u.s. experience under tsca.
The chemicals policy deficiencies identified in the E.U. by the
European Commission in its justification for REACH are essentially
identical to those of the United States:
There is a lack of health, environmental, and other information
on the great majority of chemicals in commerce; 99 percent of chemicals
in commercial circulation in the E.U., by volume, lack adequate
information on health and environmental effects.
There is an implicit presumption that chemicals are safe unless
proven otherwise by a public entity.
The ability of public agencies to assess and demonstrate chemical
risks has not kept pace with the rate of chemical production; only
about 140 of 100,000 existing chemicals in the E.U. have been subject
to risk assessments.
The UC report indicates that an array of strategies could be
employed to address this same set of problems in the U.S. The report
devotes a chapter to a discussion of the experience in Massachusetts
under the Toxics Use Reduction Act of 1989 (Chapter 6), and it lists 13
different policy mechanisms that could be used to directly or
indirectly limit chemical hazards. It proposes a set of attributes of
the most effective policy mechanisms, as follows (Chapter 7):
meet the proposed objective in a measurable way,
place the least demands on Government,
leverage market forces,
leverage existing statutes and programs,
be cost-effective and fair,
consider impacts across the chemical life cycle (including the
workplace),
ensure public access and participation,
integrate environmental and occupational health justice factors,
emphasize prevention (including green chemistry) over mitigation,
encourage continual learning by the regulated entity,
motivate technology innovation and diffusion, and
be adaptable to change.
The report finds that to close the Data Gap, Safety Gap, and
Technology Gap, California will need to: (1) require the disclosure by
chemical producers of more complete information on chemical toxicity,
ecotoxicity, exposure and other information; (2) improve the capacity
of Government to act in an efficient and timely manner in controlling
the most dangerous chemicals; and (3) implement additional incentives
that motivate industry investment in green chemistry science and
technology, and devote public resources to green chemistry education,
research, and technical assistance programs. The first two of these
parallel the intent of the REACH proposal, whereas the third is implied
but not made explicit in REACH.
The similarities between the policy goals recommended in the UC
report and those of REACH reflect the fact that both are responding to
essentially the same problems; the similarities also reflect a general
concern among the industry representatives we spoke with that
harmonization of standards across jurisdictions is becoming
increasingly important as these jurisdictions begin to contemplate
chemicals policy strategies. To prevent a scenario in which U.S.
producers are forced to contend with an increasingly diverse global
regulatory environment, the UC report suggests that some aspects of
REACH (such as data requirements) might be harmonized with chemicals
policy initiatives in California and the United States
the uc report draws four basic conclusions about the implications of
reach for california.
First, the report presents evidence suggesting that REACH will
improve the technical and commercial viability of green chemistry by
improving accountability and oversight in the chemicals market. Second,
the report notes that REACH could present a unique challenge to
California's small and medium-sized chemical producers, and that
California could take steps now to assist these businesses in meeting
REACH requirements. Third, the report proposes that REACH could present
an opportunity for California to gather toxicity and other information
on many chemicals in commercial circulation, and that for this
information to be most useful, California will need to gather sales
data on the distribution of chemicals sold in the State. Fourth, the
report concludes that while REACH is expected to drive innovation in
safer chemicals, it is also conceivable that some producers will seek
to market ``non- E.U.-compliant'' hazardous chemicals in countries
where regulatory oversight is weak, such as in the United States,
particularly during transitional ``sell-through'' periods.
______
Responses by Michael P. Wilson to Additional Questions
from Senator Jeffords
Question 1. Dr. Wilson, in the ever-expanding global market, will
the European Union's REACH initiative alter chemical industry behavior
in the United States? If so, to what extent?
Response. It is clear that REACH will affect all U.S. producers of
chemicals and chemical products that manufacture in, or import into,
the E.U. It will also indirectly affect all U.S. companies whose supply
chains include chemicals or chemical products that are manufactured in
the E.U., or that are manufactured in the United States and exported
into the E.U. It is not possible to predict how REACH will affect
``behavior'' among U.S. producers of chemicals and chemical products;
however, some chemical industry observers expect that important changes
could occur in the chemicals market as REACH is implemented, and others
suggest that the political climate surrounding chemicals policy in the
United States could be affected. These potential developments are
summarized below.
Question 2. Dr. Wilson, if hazardous chemicals are banned in the
European Union but not at home, will the U.S. market for such chemicals
expand?
Response. Thank you for these questions. It is appropriate to open
a discussion of TSCA and chemicals management in the United States with
a question pertaining to the European Union's proposed Registration,
Evaluation, and Authorization of Chemicals initiative, known as REACH.
As you know, we were asked by the California Legislature in January
2004 to evaluate chemical challenges facing California, and we, too,
recognized the importance of REACH for the U.S. chemical industry and
for United States and California chemical management programs. Our
report, Green Chemistry in California: A Framework for Leadership in
Chemicals Policy and Innovation, which the UC Office of the President
released to the Legislature on March 14, 2006, discusses REACH at some
length. I will refer you in some questions to responses I prepared for
Senator Inhofe, above, which describe issues related REACH.
a. reach will introduce a new level of accountability for chemical
producers with operations in the e.u.
Over a period of 11 years, REACH will introduce new
responsibilities and a greater degree of Government oversight for U.S.
producers of chemicals and chemical products (that manufacture in, or
import into, the E.U.). Generally speaking, producers will be
responsible for disclosing more information about the health and safety
of the chemicals they produce (particularly for chemicals sold in
larger volumes); they will be required to distribute this information
into supply chains to end users; and they will be required to gather
information from end users to determine how chemicals are being used.
REACH will gradually remove the distinction between chemicals already
on the market (so-called ``existing'' chemicals) and ``new'' chemicals.
Producers will need to seek Government approval for certain chemicals
on a use-by-use basis. These so-called ``chemicals of very high
concern'' will be presumptively removed from commercial circulation
unless the producer can demonstrate that the production and use of
these chemicals can take place under adequately controlled conditions,
or if this is not the case, that their ``socio-economic benefits
outweigh the risk to human health or the environment. . . and if there
are no suitable alternatives.' These measures represent a degree of
responsibility and oversight that is new in the global chemical
production system, including that of the U.S. This will engender a new
level of accountability in some sectors of the global chemicals market,
including that of the U.S.
__________
Statement of Gail Charnley, Ph.D., President, Healthrisk Strategies
Since the early 1990s, our awareness and understanding of the
special susceptibilities of children to chemical exposures has improved
substantially. Our precautionary methods for setting limits on chemical
exposures take children's unique exposure characteristics into account
and provide margins of safety that protect children when greater
susceptibility to toxicity is known or suspected. A variety of
voluntary programs have been initiated under the umbrella of TSCA that
have generated basic toxicity data for most of the chemicals in
commerce by volume, including information about children's exposures
and susceptibilities. These efforts will continue to produce data and
chemical-specific exposure limits will continue to be generated and
fine-tuned as new data on developmental toxicity become available.
Meanwhile, to the extent they are available, environmental and
biomonitoring data demonstrate that chemical emissions and body burdens
continue to decline.
tsca progress
In its 1997 final report, the Presidential/Congressional Commission
on Risk Assessment and Risk Management\1\ (for which I served as
executive director) evaluated and made recommendations regarding the
risk assessment and risk management policies and practices across the
Federal Government. With regard to TSCA, the Risk Commission concluded:
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\1\The Commission was mandated by the 1990 amendments to the Clean
Air Act, comprised ten commissioners appointed in a bipartisan manner,
and operated between 1994 and 1997.
Given the divergent views about the situation, the history of
litigation, the advances in the world of testing and toxicologic
interpretation, and the willingness of all parties to engage in
dialogue, the Commission recommends that EPA, industry, academia, and
worker, consumer, and environmental organizations be convened in a
sustained stakeholder process to review TSCA and its implementation, to
propose criteria for developing test batteries, to seek consensus on
making weight-of-evidence judgments about such data. [and] to define
criteria for making data more accessible to the public.\2\
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\2\U.S. Commission on Risk Assessment and Risk Management (1997).
Final Report, Volume 2. Risk Assessment and Risk Management in
Regulatory Decision-A faking. GPO #055-000-00567-1. page 128. Available
at http://www.riskworld.com/nreports/1996/risk--/rpt:RR6ME001.HTNM
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Since the time of the Commission's report, a variety of activities
has taken place that is consistent with that recommendation. Among the
prominent ones are:
U.S. EPA convened the National Pollution Prevention and Toxics
Advisory Committee, a national advisory body that provides advice.
information. and recommendations on the overall policy and operation of
programs managed by the Office of Pollution Prevention and Toxics in
performing its duties and responsibilities under TSCA. The Committee
provides a forum for public discussion and the development of
independent advice to the EPA Administrator by taking advantage of the
experience, strengths and responsibilities of a broad range of Agency
constituents and stakeholders.
The l High Production Volume (HPV) Challenge Program was launched
in 1998 as a cooperative effort among EPA. the American Chemistry
Council, and Environmental Defense. More than 300 companies and
consortia volunteered for the program, providing safety information on
nearly 95 percent of U.S. chemical production by volume. The HPV
program is a tiered testing program that generates a basic set of
toxicity data first on key end points, including reproductive,
developmental, systemic, and genetic toxicity. The results of the basic
testing allow scientists to evaluate potential hazards and decide
whether additional toxicity tests are needed and, if so, which specific
tests would be appropriate. This tiered testing and evaluation
framework promotes an efficient use of resources, including laboratory
animals, by targeting substances posing the greatest potential hazards.
The HPV Challenge Program is nearly complete and has greatly
accelerated the public availability of hazard screening data and
critical information used to evaluate the potential health and
environmental effects of HPV chemicals. The HPV program is now
supplemented by the Extended High Production Volume Program, a
voluntary, industry-led initiative that continues to generate toxicity
screening data for newer HPV chemicals and to make those data publicly
available.
The Voluntary Children's Chemical Evaluation Program is a
voluntary pilot program that is part of EPA's Chemical Right-to-Know
Initiative. The goal of the pilot is to better understand potential
health risks to children associated with certain chemical exposures.
The key question of the program is whether the potential hazards,
exposures, and risks to children have been adequately characterized
and, if not, what additional data are necessary. EPA has asked
companies that manufacture or import 23 chemicals found in human
tissues and the environment to volunteer to sponsor chemical
evaluations. Sponsorship requires the companies to collect or develop
health effects and exposure information on their chemicals and then to
integrate that information in a risk assessment and a data needs
assessment. Like the HPV program, VCCEP uses a tiered testing scheme to
generate a basic set of toxicity and exposure data and then uses the
results to determine what types of further testing is needed. The
results of the pilot program thus far illustrate how various parties
can work together under a voluntary program and how toxicity and
exposure data can be integrated to make decisions regarding the
adequacy of risk information for children. The program has been in
operation since 2002 and is currently being reviewed and fine-tuned.\3\
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\3\For a status report, see Williams PRD, Patterson J, Briggs DW
(2006). VCCEP: Progress on evaluating children's risks and data needs.
Risk Analysis 26:781-801
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These programs demonstrate that voluntary, multi-stakeholder
initiatives have been initiated and are succeeding under the umbrella
of TSCA. Since the mid-1990s, basic toxicity data have been generated
for most of the chemicals in commerce by volume and research efforts
have provided information about children's exposures and
susceptibilities that has been incorporated into risk assessment and
chemical standard-setting. These efforts will continue to generate data
that will contribute to better and better chemical regulation and to
safer, healthier children.
biomonitoring and the role of the environment in children's health
Establishing a role for chemicals in public health in general or
children's health in particular is complicated by the fact that
``environment'' includes many more complexities than just chemical
contaminants, such as physical safety, nutrition, socioeconomic
factors, infectious agents, naturally occurring substances, ultraviolet
radiation, tobacco smoke, and natural disasters. The National
Children's Study defines a child's environment broadly, including
natural and man-made environment factors, biological and chemical
factors, physical surroundings, social factors, behavioral influences
and outcomes, genetics, cultural and family influences and differences,
and geographic locations.\4\ Notable among the varying definitions of
environment and the various attempts to quantify environmentally
attributable proportions of disease is the comparatively small role
that chemical exposures evidently play against the backdrop of
socioeconomic conditions, behavioral factors, psychological factors,
infectious agents, nutrition, and other considerations.
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\4\U.S. EPA/Environmental Protection Agency (2001). The National
Children's Study. Conducted in partnership with the U.S. Department of
Health and Human Services. Available at http://
www.nationalchildrensstudy.gov/
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Several studies have attempted to evaluate the role of environment
in ill health. For example, one evaluation estimated the extent to
which global ill health is attributable to environmental risk factors,
excluding genetics, diet, smoking, and some component of injuries but
including food additives, infectious agents, pesticides, passive
smoking, behavioral factors related to personal and household hygiene,
some malnutrition, and the natural environment (e.g., dust and natural
disasters).\5\ That study concluded that 12 percent of disease in
established market economies is potentially attributable to
environmental factors. Compared to all ages, the proportions of
children's environmentally attributable disease burden is about 0.8
percent.
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\5\Smith KR, Corvalan CF, Kjellstrom T (1999). How much global ill
health is attributable to environmental factors? Epidemiology 10:573-84
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This is not to say that chemical exposures do not play a role or
that their contribution should be ignored; even if their contribution
is small, it could constitute a public health problem by virtue of the
numbers of people affected. However, given their relatively small
contribution, chemical contaminants should not be treated in isolation
from other factors if an effective environmental strategy for
protecting. and improving public health--and especially children's
health--is desired.
Attributing specific health outcomes to specific chemicals at
environmentally relevant levels of exposure is, except in the rarest of
cases, unlikely to be either possible or defensible. For example, while
the cause of childhood asthma may be traced to genetic influences, its
occurrence may be triggered by environmental tobacco smoke or urban air
pollution. An environmental health strategy that targets specific
exposures without considering the contributions of other risk factors
and the multi factorial etiology of disease will not be effective. In
any case, dissecting out the contributions of genetics and economic,
social. cultural. behavioral, and psychological factors for the purpose
of identifying and reducing environmental risks in general, or chemical
risks in particular, is unlikely to be straightforward. As EPA put it
recently:\6\
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\6\EPA Environmental Protection Agency (2003). Draft Report on the
Environment 2003. Technical Document. EPA-600-R-03-050. Office of
Research and Development and Office of Environmental Information.
Washington. DC. Available at http://www.epa.gov/indicators/roe/
index.htm
One of the greatest challenges to elucidating the connection
between environmental exposure and disease is the fact that exposure to
an environmental pollutant or stressor is rarely the sole cause of an
adverse health outcome . . . Other factors include, for example, diet,
exercise, alcohol consumption, heredity. medications. and whether other
diseases are present. . . Also, different people have different
vulnerabilities. . . All these factors make it difficult to establish
a causal relationship between exposure to environmental pollutants and
disease outcome. . .
For the reasons discussed above, biomonitoring data that provide
information solely about trace levels of chemicals in blood or urine at
a single point in time cannot be used to draw conclusions about the
likelihood of disease except in very rare cases. Biomonitoring data can
be used to demonstrate trends in exposure over time, to establish that
exposure has occurred, to identify individuals with unusual exposures,
or to help clarify the relationship between exposure and dose in some
cases, but generally do not provide an indication with regard to the
likelihood of ill health. As the recent National Academy of Sciences
report Human Biomonitoring for Environmental Chemicals put it:
The ability to generate new biomonitoring data often exceeds the
ability to evaluate whether and how a chemical measured in an
individual or population may cause a health risk or to evaluate its
sources and pathways of exposure. . . For sonic chemicals (such as
mercury and lead), the health risks and effects are well known; but for
most of the chemicals currently measured, the risks cannot be
interpreted.\7\
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\7\National Academy of Sciences/National Research Council (2006).
Human Biomonitoring for Environmental Chemicals. National Academy
Press. Washington, DC. Page 2
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As the Centers for Disease Control and Prevention puts it in its
National Report on Human Exposure to Enviroinnonal Chemicals:
The presence of a chemical in a blood or urine specimen does not
mean that the chemical causes a health risk or disease.\8\
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\8\Centers for Disease Control and Prevention (2005). National
Report on Human Exposure to Environmental Chemicals. Third Report.
Atlanta, GA. Available at http://www.cdc.gov/exposurereport/
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Our analytic abilities increasingly permit the detection of
substances in biological samples in smaller and smaller trace
quantities. That does not mean we are increasingly at risk of chemical-
related disease. Trace levels of chemicals in the body are unlikely to
overwhelm the body's natural ability to detoxify and eliminate them.
Given our incomplete knowledge of the inter-relationships among
multiple chemical and non-chemical, environmental and non-
environmental stressors, interpretation of the potential impact of
exposure to trace levels of chemicals, if any, will probably be
dependent on eventual decoding of the human genome map. Meanwhile,
using laboratory animals to provide information on chemical toxicity
can help us identify target organ systems and target risk management
strategies. but is unlikely to provide insight with regard to the
potential impact of trace levels of chemicals.
The good news is that, to the extent that they exist, environmental
and biomonitoring trend data demonstrate that emissions and body
burdens of contaminants continue to decline. EPA emissions data show
that pollutant levels have generally declined while our economy has
grown.\9\ For example. dioxin and furan concentrations in the
environment and human tissues have been declining since the 1970s.
Samples taken of sediments from remote lakes impacted purely by
atmospheric deposition and transport and of archived soils and herbage
show low background levels of naturally occurring dioxins and furans
prior to 1900 followed by a sharp rise after 1930, coinciding with the
onset of industrialization and the large-scale production and use of
organochlorine compounds, peaking in the 1970s, with a slow decline
until the present day. Evidence for this decline has also been found in
studies on archived sewage sludge, air measurements, and biological
samples.\10\ Human tissue concentrations of 2,3,7,8-TCDD taken from
residents of Germany, France, the United States, and Canada show that
exposure has declined by more than 95 percent since 1972.\11\ Other
data show that if exposure to dioxin-like compounds stays at present
levels (which is unlikely), current body burdens will fall by more than
50 percent by 2020.\12\
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\9\See for example, EPA (2000). National Pollutant Emission Trends,
1900-1998. EPA-454/R-00-002. Office of Air Quality Planning and
Standards. Research Triangle Park, NC. Available at http://www.epa.gov/
ttn/chief/trends/trends98/trends98.pdf
\10\Euro Chlor (2003). Dioxins and Fw'ans in the Environment.
Science Dossier. Bnissels, Beleium. Available at www.eurochlor.org
\11\Aylward LL, Hayes SM (2002). Temporal trends in human TCDD body
burden: Decreases over three decades and implications for exposure
levels. Journal of Exposure Analysis and Environmental Epidemiology
12:319-328
\12\Lorber M (2002). A phannacokinetic model for estimating
exposure of Americans to dioxin-like compounds in the past. present,
and future. The Science of the Total Environment 288:81-95
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Studies show that the levels of contaminants in breast milk are
also declining. For example. data from Germany, Norway, and the
Netherlands indicate that concentrations of dioxins and brains have
decreased by at least 50 percent since 1980.\13\ Other substances for
which trend data are available show continued declines as well. The
extent to which chemicals present in breast milk present a health risk
to the breast feeding infant is not known. Virtually all national and
international expert committees have concluded that, on the basis of
available information, the benefits of breast feeding outweigh the
possible risks from chemical contaminants present in human milk at
normal levels.\14\ In fact, epidemiologic research shows that human
milk and breastfeeding of infants provide advantages with regard to
general health, growth, and development, while significantly decreasing
risk for a large number of acute and chronic diseases.\15\
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\13\LaKind JS, Berlin C. Naiman DQ (2001). Infant exposure to
chemicals in breast milk in the United States: What we need to learn
from a breast milk monitoring program. Environmental I Health
Perspectives 109:75-88
\14\La Leche International (1994). Pesticides and breast feeding.
LEAVEN 30:37-40
\15\American Academy of Pediatrics (1997). Policy statement on
breast feeding and the use of human milk. Pediatrics 100:1035-1039
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An expert committee was convened by the European Centre for
Ecotoxicology and Toxicology of Chemicals to review trends over time in
chemical exposures and in children's health.\16\ That committee drew a
number of conclusions that are germane to evaluating the role of
chemical exposures and children's health:
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\16\European Centre for Ecotoxicology and Toxicology of Chemicals
(ECETOC) 2005. Trends in Children's Health and the Role of Chemicals: A
State of the Science Review. Brussels.
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In comparing time trends of disease improved reporting systems,
changes in diagnostic criteria/procedures, a more active approach to
early detection of cases to improve prognosis and a better health care
system in general must be taken into account. There is clear evidence
of increasing rates of asthma in children, although rates in some
countries may now have stabilized. There is no convincing evidence of
widespread trends in other acute or chronic childhood respiratory
diseases. Indoor air quality appears to be related to both asthma and,
in some cases, to other respiratory-related diseases (such as otitis
media). Interpretation of the available information on asthma and
allergies is made difficult by inconsistent application of diagnostic
criteria over place and time. Contemporaneous with the increasing
frequency of asthma, data also suggest that other atopic disorders such
as upper respiratory and food allergy may be increasing. Atopic
dermatitis remains the leading skin disorder in young children.
Although the frequency of neurodevelopmental disorders such as
autism and attention deficit disorder is commonly believed by the
public to be increasing, the limited data available do not support this
perception.
Data on reproductive effects are also limited and often suffer
from serious data quality issues. Whilst geographic heterogeneity is
apparent, broad population trends for these outcomes (sperm quality,
hypospadias, cryptorchidism) are difficult to identify except for
decreasing age at puberty in females.
There is no evidence for major trends in the frequency of
childhood cancer. Data indicate that developed countries tend to have a
gradually increasing incidence of leukaemia with a corresponding drop
in the incidence of lymphoma. Increases in brain tumour frequency are
possibly related to the development of new diagnostic capabilities
rather than to a true change in the incidence in the rate of malignant
disease. With the increasing number of childhood cancer survivors,
secondary cancers following chemotherapy appear to be on the increase.
A wide range of environmental factors is thought to have an
impact on children's health, extending well beyond industrial
chemicals. These factors include nutrition (protein, vitamins, anti-
oxidants), lifestyle and behavior choices such as tobacco and alcohol
use, parental health, socio-economic status, choice of living
environment (urban vs. rural, etc.), and parent-sibling behavior. From
the available data, no general conclusions on the contribution of
specific chemicals can be drawn across the multiple health outcomes
addressed in [the committee's] report.
It is illogical to presume that any chemical exposure is dangerous
and that any potential chemical hazard poses a risk. And, even if they
were occurring, increases in childhood health problems would be
unlikely to be associated with environmental contaminant concentrations
that are decreasing. Even the New York Times notes that people alive
today in developed countries are healthier than they used to be, live
longer, get heart disease and other chronic illnesses later in life
than they used to, experience less disability, and have higher IQs.\17\
Much of those improvements is due not just to better medical care but
also to better nutrition, higher birth weights, and fewer hazardous
occupational and environmental exposures.
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\17\New York Times, Sunday July 30, 2006
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limiting chemical exposures
Current EPA methods for setting standards to limit chemical
exposures are precautionary and account for the possibility that
children can be more susceptible than adults to chemical toxicity. When
information on developmental toxicity is available, it is considered.
When developmental toxicity is the most sensitive end point of
toxicity, it serves as the basis for standard-setting. When no
information on developmental toxicity is available, a database
uncertainty factor is used to make the standard more stringent than it
would be otherwise, in order to be precautionary and account for the
possibility that children might be more susceptible than adults.
Traditionally, chemical risk assessment has been performed by
comparing a measured or estimated human dose to a dose associated with
a toxicity endpoint, such as a no-observedadverse-effect level (NOAEL)
or a benchmark dose, after adjustment by adequate uncertainty and/or
safety factors. Adjusting for uncertainty generally involves dividing a
NOAEL or benchmark dose derived from human data by 10 to yield a level
of exposure that would be protective of individuals who might be more
sensitive than those tested or observed. If no human data are
available, a NOAEL or benchmark dose identified using laboratory
animals is divided by 100-10 to protect sensitive individuals
(intraspecies factor) and 10 to account for the possibility that humans
could be more sensitive than the species tested (interspecies factor).
The resulting lifetime exposure level is considered likely to be
without adverse effects in humans, including sensitive subgroups or
life stages, because the intraspecies uncertainty factor is meant to
protect sensitive groups such as children or the elderly.
A number of scientists have attempted to investigate quantitatively
whether the intraspecies uncertainty factor is adequate to account for
the variability to chemical toxicity between the overall human
population and its potentially more sensitive groups, including
children. Dourson et al (2002) reviewed 17 studies that performed
quantitative analysis of the extent of toxicodynamic and
pharmacokinetic variability using different data and different starting
points, some specifically evaluating age effects in both humans and
animals.\18\ That analysis suggests that a high percentage of the
population, including children, is protected by using a 10-fold
uncertainty factor for human variability. Studies indicating that in
some cases the young would not be protected by the standard uncertainty
factor were those that evaluated acute lethality in laboratory animals
(LD5os) and are therefore less relevant to evaluating risks from
environmental exposures. Based on specific comparisons for newborns,
infants, children, and adults, the range of the population protected is
between 67 and 100 percent. Studies using larger populations that
include sensitive individuals suggest that the value is closer to 100
percent.\19\
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\18\Dourson M, Charnley G, Scheuplein R. 2002. Differential
Sensitivity of Children and Adults to Chemical Toxicity. II. Risk and
Regulation. Regulatory Toxicology and Pharmacology, 35:448-467
\19\Hattis D, Banati P, Goble R. 1999a. Distributions of Individual
Susceptibility Among Humans for Toxic Effects. How Much Protection Does
the Traditional Tenfold Factor Provide for What Fraction of Which Kinds
of Chemicals and Effects? Annals of the New York Academy of Sciences
895:286-316; Hattis D, Banati P, Goble R, and Burmaster D. 1999b. Human
Interindividual Variability in Parameters Related to Health Risks. Risk
Analysis 19:705-720; Renwick AG and Lazarus NR. 1998. Human variability
and noncancer risk assessment an analysis of the default uncertainty
factor. Reg Toxicol Pharmacol 27:3-20
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Other evaluations concur with those of Dourson et al (2002). For
example, the German Research and Advisory Institute for Toxic Chemicals
concluded that, based on toxicokinetic differences, the most
susceptible group of neonates is protected by a 10-fold intraspecies
uncertainty factor in most cases.\20\ The authors also conclude,
however, that the protection of neonates and infants may require
consideration of their lower xenobiotic clearance rates and recommend
using a log-normal density function, based on the differences in adult
and neo-natal clearance rates, in the framework of probabilistic risk
assessments.
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\20\Schneider KI, Gerdes H, Hassauer M, Oltmanns J, Schulze J.
2002. BerUcksichtigung der Risikogruppe Kind bei der Ableitung
gesundheitsbezogener Umweltstandards. UFOPLAN-Nr. 201 61 215.
Forschungs- and Beratungsinstitut Gefahrstoffe GmbH (FoBiG), Freiburg
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Conclusions about the adequacy of the 10-fold intraspecies
uncertainty factor do not mean that interindividual sensitivity varies
10-fold, as is often thought. Its application to a value in the low end
of the distribution of human sensitivities, such as a NOAEL, and its
use in conjunction with other uncertainty factors and conservative
assumptions, actually cover total human sensitivity variations of 100
to 1,000 times (see Exhibit 4).
In the absence of important data on a substance's toxicity, such as
reproductive or developmental toxicity, standard EPA practice has been
to use a ``database uncertainty factor'' in addition to the other
factors. The database uncertainty factor is generally a factor of 10
that is added to the calculation of an exposure limit, making it ten
times more stringent than it would be otherwise. In other words, EPA
uses an extra uncertainty factor when there is inadequate information
about developmental effects, reproductive effects, or developmental
neurotoxicity in order to be precautionary and health-protective.
age and chemical exposures
Children's exposures to chemicals from their environment are
qualitatively and quantitatively different from those of adults. For
example, children are likely to be exposed to different levels of
chemical contaminants in foods than adults because they consume more
calories of food per unit of body weight, fewer types of foods, and
more processed foods.\21\ The National Academy of Sciences report
Pesticides in the Diets of Infants and Children\22\ concluded that
differences in diet and thus in dietary exposure to pesticide residues
account for most of the potential differences in pesticide-related
health risks that may exist between children and adults.
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\21\U.S. Department of Agriculture (1985). Nationwide Food
Consumption Survey: Continuing Survey of Food Intakes by Individuals,
Women 19-50 Years and Their Children 1-5 Years. Human Nutrition
Information Service. Washington, DC
\22\National Academy of Sciences/National Research Council (1993).
Pesticides in the Diets of Infants and Children. National Academy
Press. Washington, DC
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Normal childhood behaviors such as hand-to-mouth activity and
crawling on the floor or ground can increase children's exposures to
potential toxicants through ingestion and contact with dusts and
residues. Greater risk of lead poisoning from lead-based paint is a
well-known example of that problem. Children breathe more than adults
on a body-weight basis, so may be exposed to higher doses of air
pollutants. Children consume more water than adults on a body-weight
basis, so may be exposed to higher doses of water pollutants. Infants
consume breast milk, an important source of nutrition and immunologic
protection, but sometimes a source of fat-soluble contaminants such as
PCBs. Children may not perceive hazards as quickly or effectively as
adults, so may experience some greater exposures by not avoiding them
as readily. In contrast, adults have higher exposures than children to
chemicals associated with activities such as home car repair, cleaning,
home painting, and other recreational or maintenance activities.
Occupational exposures also would be greater for adults than children,
although there are situations, such as pesticide application, where
parents' exposures result in children's exposures when applicators
return home after working.
Exposure is not the only determinant of toxicity, however. Once
exposure has occurred, age-related differences in the body's ability to
absorb, distribute, metabolize, and eliminate chemicals can produce
different doses from the same exposures. Risks to health are determined
by exposure, dose, and susceptibility. Even if children's exposures or
doses of substances exceed those of adults on a body-weight basis, they
will still not be at risk unless the doses are high enough to produce
toxicity. The dose or level of exposure that is capable of producing
toxicity is determined by children's inherent susceptibility, which may
be greater than adults in some cases and less in others.
age and susceptibility
There are many physiologic and pharmacologic reasons why the
susceptibility of children and adults to the impacts of chemical
exposures may differ. The developing organism experiences many complex,
integrated events involving the regulation of cell growth,
differentiation, and morphogenesis. Interfering with those events
through mutation or through altered cell division, enzyme function, or
energy sources can have significant adverse impacts on development.\23\
Many environmental factors can have an impact on normal development,
including nutrition and folic acid availability, maternal smoking and
alcohol consumption, prescription drugs, and chemical contaminants such
as lead and organic mercury.
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\23\Wilson J (1977) Current Status of Teratology; General
Principles and Mechanisms Derived from Animal Studies. In: Handbook of
Teratology; General Principles and Etiology, ed. J Wilson and F Fraser.
New York: Plenum Press; Faustman EM, Silbernagel SM, Fenske RA,
Burbacher TM, Ponce RA (2000). Mechanisms underlying children's
susceptibility to environmental toxicants. Environmental Health
Perspectives 108:13- 21
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Children are more sensitive than adults to the toxic effects of
many chemicals, such as lead. At the same time, children are often less
sensitive to many chemicals than are adults. For example, unlike the
situation in adults, liver toxicity and death from acetaminophen
poisoning is extremely rare in children\24\ The metabolism and
elimination rates of many drugs and other substances are known to be
higher in children than adults. As a result, children will often have
lower body burdens of drugs or chemicals than adults for the same
exposures, when expressed on a body-weight basis. For example, as
Exhibit 1 shows, morphine is cleared about 2-3 times faster by children
than by adults. The chemotherapy drug methotrexate is cleared six times
faster by children than by adults. The antipsychotic drug Thorazine is
cleared five times faster by children than by adults. As a result, kids
require higher pharmacologic doses than adults of those drugs to
achieve efficacy.
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\24\Penna A, Buchanan N (1991). Paracetamol poisoning in children
and hepatotoxicity. British Journal of Clinical Pharmacology 32:143-149
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Thus, while some chemicals may be metabolized to toxic metabolites
more quickly by children, those metabolites are likely also to be
deactivated and eliminated more rapidly, presumably becoming less toxic
by decreasing their effective doses. Children's generally more rapid
elimination rates may compensate in part for any increased sensitivity
during development.\25\ A number of environmental exposures, including
pesticides, parental occupational exposures, and infectious organisms
have been suggested as possible precursors to cancer or other health
effects in children; however, the considerable research conducted to
date has yielded inconsistent or limited evidence identifying those
factors as disproportionate threats to children's health.\26\
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\25\Renwick AG (1998). Toxicokinetics in infants and children in
relation to the ADI and TDI. Food Additives and Contaminants 15S:17-35
\26\Public Health Policy Advisory Board (1999). Health and the
American Child. Part I: A Focus on Mortality Among Children. Risks,
Trends, and Priorities for the Twenty-First Century. Washington, DC
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Rodent bioassays show that younger animals are less susceptible to
chemical carcinogens in some cases and more susceptible in others.
Pesticides in the Diets of Infants and Children included a table
summarizing the results of studies that had been performed through 1983
in which the effects of age on chemically induced carcinogenesis in
rodents had been evaluated. That list was updated in 2001.\27\ As can
be seen in Exhibit 2, the data indicate that there are a similar number
of studies showing that younger animals are less susceptible than
adults to chemically induced carcinogenesis as there are showing that
they are more susceptible under the conditions of the bioassays. A
number of studies showed that age played no role at all in
susceptibility.
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\27\Charnley G, Putzrath RM (2001). Children's health,
susceptibility, and regulatory approaches to reducing risks from
chemical carcinogens. Environmental Health Perspectives 109:187-192
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The National Academy of Sciences report concluded that those
results clearly demonstrate that age may be an important factor in
susceptibility to chemically induced carcinogenesis, but they do not
support the conclusion that younger animals are always more susceptible
than older animals. The database also illustrates the difficulty
associated with assessing quantitatively the extent of the differences
in susceptibility due to age. Virtually all of the studies evaluated
used only one dose level, so the underlying dose-response relationships
are unknown and comparison of sensitivities is possible only at the
relatively high, single dose levels used. Generalizations about the
effect of age on susceptibility to chemical carcinogens are thus
difficult to make.
Data on acute chemical toxicity show similar results. Exhibit 3
shows how the lethal dose of DDT varies with age, indicating that in
this case, infant rats are much less susceptible to toxicity than adult
rats. A review by Ed Calabrese of the data available on LD50s showed
only small differences due to age. In some cases, young animals were
more susceptible and, in some cases, adult animals were more
susceptible.\28\ In only a few cases did the differences exceed an
order of magnitude, however, and in many cases, there were no
differences. Data on the maximum tolerated doses of chemotherapeutic
agents in humans show that they were frequently higher for children
than adults, indicating greater susceptibility of adults, although the
differences between age groups were usually less than or equal to
two.\29\ Studies of pesticide acute toxicity also show variability. In
one study, no more than 2- to 3-fold differences in sensitivity were
observed, with the younger animals more sensitive to toxicity than
older animals in only four out of 36 cases.\30\ In another study,
however, 14 of 15 organophosphate pesticides showed greater acute
toxicity to young rats than to adult rats.\31\
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\28\Calabrese EJ (1986). Age and Susceptibility to Toxic
Substances. New York: John Wiley & Sons
\29\Bruckner JV (2000). Differences in sensitivity of children and
adults to chemical toxicity: the NAS panel report. Regulatory
Toxicology and Pharmacology 31:280-285
\30\Gaines TB, Linder RE (1986). Acute toxicity of pesticides in
adult and weanling rats. Fundamental and Applied Toxicology 7:299-308
\31\Brodeur J, DuBois KP (1963). Comparison of acute toxicity of
anticholinesterase insecticides to weanling and adult male rats.
Proceedings of the Society for Experimental Biology and Medicine
114:509-511
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Chemical exposures can affect normal prenatal or childhood
development by interfering--either directly or indirectly--with the
large network of regulatory genes that control growth and development.
In contrast to physiological responses, which can vary in response to
exposures or other stimuli and then return to normal, developmental
systems move inexorably forward.
Perturbation of critical components of the regulatory gene network
can have two possible outcomes. The consequences of interference may
not be repaired as development moves forward or the complexity of the
system may confer the ability to compensate for perturbations, should
they occur, illustrating again the difficulty of making generalizations
about age and susceptibility.\32\
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\32\Davidson EH, Rast JP, Oliveri P, Ransick A, Calestani C, Yuh
CH, Minokawa T, Amore G, Hinman V, Arenas- Mena C, Otim 0, Brown CT,
Livi CB, Lee PY, Revilla R, Rust AG, Pan Z, Schilstra MJ, Clarke PJ,
Arnone MI, Rowen L, Cameron RA, McClay DR, Hood L, Bolouri H (2002). A
genomic regulatory network for development. Science 295:1669-1678
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What the scientific evidence on age-related susceptibility to the
effects of chemical contaminants does show is that children may be more
than, less than, or just as sensitive as adults, depending on the
chemical and the exposure situation. Children may be less sensitive to
the effects of a chemical than adults if they do not absorb it as
readily, if they clear it more rapidly, if they lack the enzymes
required to activate it, if they detoxify it more quickly, or if they
compensate more readily for any damage. Most of the available
information on age-related differences in sensitivity comes from
experiments using single, high doses of chemicals that produced short-
term, acute toxicity, however. Those observations may be poor
predictors of what occurs when low doses of chemicals are received over
long periods of time or of developmental toxicity. Long-term exposure
to low doses of chemicals can produce different types of toxicity than
short-term exposure to high doses. On the other hand, low environmental
exposures to chemicals are less likely to overwhelm developing
detoxification and other defense mechanisms, so age-related differences
at low doses may be quantitatively less pronounced than at high
doses.\33\ For example, data for the insecticide chlorpyrifos show that
young animals are more sensitive than adults to its nervous system
toxicity at high doses, but are less or similarly sensitive than adults
at low doses.\34\ The reason for the difference in this case is that
young animals can compensate for toxicity faster than adult animals can
at lower doses by synthesizing replacement cholinesterase faster, but
cannot compensate for it fast enough at higher doses.
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\33\Scheuplein R, Chamley G, Dourson M (2002). Differential
sensitivity of children and adults to chemical toxicity. I. Biological
basis. Regulatory Toxicology and Pharmacology 35:429-447
\34\Mattson JL, Maurissen PJ, Nolan RJ, Baal( KA (2000). Lack of
differential sensitivity to cholinesterase inhibition in fetuses and
neonate compared to dams treated perinatally with chlorpyrifos.
Toxicological Sciences 53:438-446
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The effect of age on susceptibility to chemical toxicity appears to
depend on the chemical of concern, the toxic effect that is observed,
the dose that is received, and the period of development during which
exposure occurred, with infants, children, or the developing fetus more
sensitive than adults in many cases but less sensitive in others.
Susceptibility to chemical toxicity is the result of extremely complex
biological interactions and there is no systematic method or model to
predict age-related susceptibility.\35\ There is no scientific support
for any statement implying that children are always more sensitive than
adults to environmental chemical exposures.
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\35\Wargo J (1996). Our Children's Toxic Legacy. New Haven: Yale
University Press
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______
Responses by Gail Charnley to additional Questions
from Senator Inhofe
Question 1. Dr. Charnley, it has been suggested that children are
more highly exposed to industrial chemicals and thus they are a more
vulnerable subpopulation that TSCA needs to categorically protect.
Scientifically, can it be assumed that children have higher exposure in
all cases and can it be assumed that the children are always more
vulnerable than adults to chemicals to which they are exposed?
Response. Children are more highly exposed to chemicals than adults
in many cases, although not always. For example, children are likely to
be exposed to different levels of chemical contaminants in foods than
adults because they consume more calories of food per unit of body-
weight, fewer types of foods, and more processed foods. Children's
chemical exposures and metabolic profiles can be qualitatively and
quantitatively different from those of adults, so they may experience
higher or lower doses on a body-weight basis for the same exposure
levels. When possible, chemical risk assessments should include
consideration of different exposure characteristics for children and
any other groups of people or particular life stages that might be more
or less exposed than average. Children can be more sensitive to a
certain chemical toxicity than adults because they may be more
vulnerable to external challenges during critical stages of the
developmental process. In other cases, they can be less sensitive to
chemical toxicity than adults due to more efficient elimination
processes, less mature activating enzymes, and enhanced ability to
repair damage. The intrinsic relative susceptibility of children
depends on the specific physical, toxicological, and metabolic
characteristics of the particular chemical at issue and on the exposure
situation of concern. Broadly based statements indicating that children
are generally more sensitive to chemical insults are not supported by
existing scientific data. And, even if they were occurring, increases
in childhood health problems would be unlikely to be associated with
environmental contaminant concentrations that are decreasing. In
developed countries, people are healthier than they used to be, live
longer, get heart disease and other chronic illnesses later in life
than they used to, experience less disability, and have higher IQs.
Those improvements are due not just to better medical care but also to
better nutrition, higher birth weights, and fewer hazardous
occupational and environmental exposures. There is no evidence for a
relationship between the U.S. infant mortality rate and exposure to
chemicals from the environment.
Question 2. Dr. Charnley, many allege that TSCA does nothing to
protect children's health. How do TSCA and the various programs in
OPPTS address children's health issues?
Response. Several voluntary, multistakeholder programs evaluating
children's health as related to chemical exposures have been
successfully initiated and conducted under the umbrella of TSCA. For
example, the High Production Volume testing program has generated a
basic set of toxicity data on key end points, including reproductive,
developmental, systemic, and genetic toxicity. The results of the basic
testing allow scientists to evaluate potential hazards and decide
whether additional toxicity tests are needed and, if so, which specific
tests would be appropriate. In other words, if initial chemical testing
indicates that a threat to children is possible, further testing
focuses on that possibility. Another program, the Voluntary Children's
Chemical Evaluation Program is a voluntary pilot program that is part
of EPA's Chemical Right-to-Know Initiative. The goal of the pilot is to
better understand potential health risks to children associated with
certain chemical exposures. The key question of the program is whether
the potential hazards, exposures, and risks to children have been
adequately characterized and, if not, what additional data are
necessary. The results of the pilot program thus far illustrate how
various parties can work together under a voluntary program and how
toxicity and exposure data can be integrated to make decisions
regarding the adequacy of risk information for children. Finally, EPA's
pesticides program includes explicit consideration of children's
potentially greater exposures and sensitivities. Pesticide sponsors
must provide data indicating that children are not at increased risk
compared to adults if they do not wish to have their product regulated
more stringently than it would be if children are at greater risk or if
no data on children's potential risks are available.
Question 3. Dr. Charnley, you mentioned some groups for whom you do
work. Can you elaborate on your work for industry, non-profits and
trade organizations?
Response. I work only part-time. I spend more than half of the time
that I work working pro bono for organizations such as the National
Academy of Sciences, the Environmental Literacy Council, the National
Toxicology Program, the Society for Risk Analysis, and the
Environmental Law Institute. When I get paid for work, my clients have
been generally a mix of nonprofits (e.g., American Council on Science
and Health, Ranchers-Cattlemen Action Legal Fund, Public Health Policy
Advisory Board), Government (e.g., U.S. Environmental Protection
Agency, U.S. Agency for International Development, Agency for Toxic
Substances and Disease Registry, State of California), industry
associations (e.g., American Chemistry Council, CropLife America),
companies (e.g., Bayer CropScience, 3M, United States Borax), and law
firms (e.g., Crowell & Moring, Schiff Hardin, Kirkland & Ellis). I have
also done some teaching at Yale, Harvard, Georgetown, and George Mason.
An elaboration of the kinds of work I have conducted can be found on my
website, www.healthriskstrategies.com.
______
Responses by Gail Charnley to Additional Questions
from Senator Jeffords
Question 1. Dr. Charnley, you mention in your testimony that there
are several voluntary initiatives, including the HPV Challenge Program
that are succeeding under the umbrella of TSCA. However, I understand
that problems exist in this program such as companies not volunteering
to provide data on all HPV program chemicals and EPA has no mechanism
for placing these chemicals on the HPV list once they are produced in
greater volume. How would you remedy these problems?
Response. It is true that some companies did not volunteer to
sponsor chemicals in the HPV Challenge Program. Those chemicals not
sponsored in the program are called ``orphans.''
However, TSCA does provide a mechanism through which EPA can obtain
health and environmental information from those companies. Sections
8(a) and 8(d) of TSCA enable EPA to order companies that make or import
those orphan chemicals to provide production information and
unpublished health and safety studies. In fact, EPA issued section 8(a)
and 8(d) rules on August 16, 2006, covering 243 HPV Challenge orphan
chemicals. These rules are among EPA's Office of Pollution Prevention
and Toxics largest rulemakings in terms of the number of chemicals
covered. Companies affected by these rules must submit this health and
environmental information to EPA no later than November 14, 2006.
Additionally, under TSCA's Inventory Update Rule (IUR), as amended
in 2003, companies that manufacture or import chemicals are required to
report information periodically (e.g., the types of chemicals, the
amounts manufactured or imported, certain details about their
manufacture, and other data) to EPA. Any chemical substances produced
or imported in quantities of one million pounds or more annually are
automatically considered HPV. In 2005, at the conclusion of the HPV
Challenge Program, the chemical industry extended its HPV commitment by
launching the Extended HPV (EHPV) Program. Through the EHPV Program,
industry has committed to sponsor chemicals that were not HPV in the
original HPV Challenge Program, but were reported as HPV in the 1998
and 2002 IUR. Chemicals that are not voluntarily sponsored in the EHPV
will become ``orphans'' and may be subject to another 8(a) and 8(d)
final rule by EPA in the future, demonstrating that TSCA can be both
effective and flexible.
______
Responses by Gail Charnley to Additional Questions
from Senator Boxer
Question 1. Provide a list of all of your clients, including their
corporate or individual names, and whether they are a not-for-profit
organization.
Response. Please refer to my response to Senator Inhofe's question
No. 3.
Question 2. Provide a description of the general nature of your
work for your clients, including whether you have promoted initiatives
to limit the application of Government regulation. Please do not limit
your answers merely to work on advisory committees or boards of
directors.
Response. Please refer to my response to Senator Inhofe's question
No. 3.
Question 3. Please confirm that the Environmental Law Institute is
not a paying client of yours.
Response. Please refer to my response to Senator Inhofe's question
No. 3.
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