[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).
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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].
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \4\Battelle Report, supra n.3, at 11.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \5\GAO Report, supra n.1, at 26.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \6\Chem. Mfrs. Ass'n v. EPA, 859 F.2d 977 (DC Cir. 1988).
    \7\Id at 984-88.
---------------------------------------------------------------------------
    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).
---------------------------------------------------------------------------
    \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''].
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \13\947 F.2d 1201 (5th Cir. 1991).
    \14\GAO Report, supra n.l, at 34.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \15\Corrosion Proof Fittings, 947 F.2d at 1212.
    \16\Id. at 1213 n.11.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \17\Id. at 1216.
    \18\Id. at 1217.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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.''')).
---------------------------------------------------------------------------
    ``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\
---------------------------------------------------------------------------
    \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).
---------------------------------------------------------------------------
    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.'').
---------------------------------------------------------------------------
                      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.
---------------------------------------------------------------------------
    \27\For more details, see Battelle Report, supra n.3, at 21.
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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:
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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/
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \5\Smith KR, Corvalan CF, Kjellstrom T (1999). How much global ill 
health is attributable to environmental factors? Epidemiology 10:573-84
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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\
---------------------------------------------------------------------------
    \7\National Academy of Sciences/National Research Council (2006). 
Human Biomonitoring for Environmental Chemicals. National Academy 
Press. Washington, DC. Page 2
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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/
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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:
---------------------------------------------------------------------------
    \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.
---------------------------------------------------------------------------
     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.
---------------------------------------------------------------------------
    \17\New York Times, Sunday July 30, 2006
---------------------------------------------------------------------------
                      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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \24\Penna A, Buchanan N (1991). Paracetamol poisoning in children 
and hepatotoxicity. British Journal of Clinical Pharmacology 32:143-149
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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\
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \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
---------------------------------------------------------------------------
    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.
---------------------------------------------------------------------------
    \35\Wargo J (1996). Our Children's Toxic Legacy. New Haven: Yale 
University Press
---------------------------------------------------------------------------
                                 ______
                                 
          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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