[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]






 TESTING OF CHEMICALS AND REPORTING AND RETENTION OF INFORMATION UNDER 
                         TSCA SECTIONS 4 AND 8

=======================================================================

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON ENVIRONMENT AND THE ECONOMY

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             SECOND SESSION

                               __________

                            FEBRUARY 4, 2014

                               __________

                           Serial No. 113-114






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                    COMMITTEE ON ENERGY AND COMMERCE

                          FRED UPTON, Michigan
                                 Chairman

RALPH M. HALL, Texas                 HENRY A. WAXMAN, California
JOE BARTON, Texas                      Ranking Member
  Chairman Emeritus                  JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky               FRANK PALLONE, Jr., New Jersey
JOHN SHIMKUS, Illinois               BOBBY L. RUSH, Illinois
JOSEPH R. PITTS, Pennsylvania        ANNA G. ESHOO, California
GREG WALDEN, Oregon                  ELIOT L. ENGEL, New York
LEE TERRY, Nebraska                  GENE GREEN, Texas
MIKE ROGERS, Michigan                DIANA DeGETTE, Colorado
TIM MURPHY, Pennsylvania             LOIS CAPPS, California
MICHAEL C. BURGESS, Texas            MICHAEL F. DOYLE, Pennsylvania
MARSHA BLACKBURN, Tennessee          JANICE D. SCHAKOWSKY, Illinois
  Vice Chairman                      JIM MATHESON, Utah
PHIL GINGREY, Georgia                G.K. BUTTERFIELD, North Carolina
STEVE SCALISE, Louisiana             JOHN BARROW, Georgia
ROBERT E. LATTA, Ohio                DORIS O. MATSUI, California
CATHY McMORRIS RODGERS, Washington   DONNA M. CHRISTENSEN, Virgin 
GREGG HARPER, Mississippi            Islands
LEONARD LANCE, New Jersey            KATHY CASTOR, Florida
BILL CASSIDY, Louisiana              JOHN P. SARBANES, Maryland
BRETT GUTHRIE, Kentucky              JERRY McNERNEY, California
PETE OLSON, Texas                    BRUCE L. BRALEY, Iowa
DAVID B. McKINLEY, West Virginia     PETER WELCH, Vermont
CORY GARDNER, Colorado               BEN RAY LUJAN, New Mexico
MIKE POMPEO, Kansas                  PAUL TONKO, New York
ADAM KINZINGER, Illinois             JOHN A. YARMUTH, Kentucky
H. MORGAN GRIFFITH, Virginia
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Ohio
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina

                                 _____

              Subcommittee on Environment and the Economy

                         JOHN SHIMKUS, Illinois
                                 Chairman
PHIL GINGREY, Georgia                PAUL TONKO, New York
  Vice Chairman                        Ranking Member
RALPH M. HALL, Texas                 FRANK PALLONE, Jr., New Jersey
ED WHITFIELD, Kentucky               GENE GREEN, Texas
JOSEPH R. PITTS, Pennsylvania        DIANA DeGETTE, Colorado
TIM MURPHY, Pennsylvania             LOIS CAPPS, California
ROBERT E. LATTA, Ohio                JERRY McNERNEY, California
GREGG HARPER, Mississippi            JOHN D. DINGELL, Michigan
BILL CASSIDY, Louisiana              JANICE D. SCHAKOWSKY, Illinois
DAVID B. McKINLEY, West Virginia     JOHN BARROW, Georgia
GUS M. BILIRAKIS, Florida            DORIS O. MATSUI, California
BILL JOHNSON, Ohio                   HENRY A. WAXMAN, California (ex 
JOE BARTON, Texas                        officio)
FRED UPTON, Michigan (ex officio)

                                  (ii)



















                             C O N T E N T S

                              ----------                              
                                                                   Page
Hon. John Shimkus, a Representative in Congress from the State of 
  Illinois, opening statement....................................     1
    Prepared statement...........................................     2
Hon. Paul Tonko, a Representative in Congress from the State of 
  New York, opening statement....................................     3
Hon. Fred Upton, a Representative in Congress from the State of 
  Michigan, opening statement....................................     4
    Prepared statement...........................................     5
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................     6

                               Witnesses

Charles T. Drevna, President, American Fuel & Petrochemical 
  Manufacturers..................................................     7
    Prepared statement...........................................    10
Robert A. Matthews, McKenna, Long & Aldridge, LLP, on Behalf of 
  the Consumer Specialty Products Association....................    16
    Prepared statement...........................................    18
Brent Grazman, Vice President, Quality Assurance, Viasystems 
  Group, Inc., on Behalf of IPC--The Association Connecting 
  Electronics Industries.........................................    28
    Prepared statement...........................................    30
Beth D. Bosley, President, Boron Specialties, on Behalf of the 
  Society of Chemical Manufacturers and Affiliates...............    40
    Prepared statement...........................................    42
Catherine Willett, Director, Regulatory Toxicology, Risk 
  Assessment, and Alternatives, The Humane Society of the United 
  States.........................................................    47
    Prepared statement...........................................    49
Jennifer Sass, Senior Scientist, Natural Resources Defense 
  Council........................................................    63
    Prepared statement...........................................    65
Jerome Paulson, Chairperson, Executive Committee of the Council 
  on Environmental Health, American Academy of Pediatrics........    78
    Prepared statement...........................................    80

 
 TESTING OF CHEMICALS AND REPORTING AND RETENTION OF INFORMATION UNDER 
                         TSCA SECTIONS 4 AND 8

                              ----------                              


                       TUESDAY, FEBRUARY 4, 2014

                  House of Representatives,
       Subcommittee on Environment and the Economy,
                          Committee on Energy and Commerce,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:03 a.m., in 
room 2123 of the Rayburn House Office Building, Hon. John 
Shimkus (chairman of the subcommittee) presiding.
    Members present: Representatives Shimkus, Pitts, Murphy, 
Latta, Harper, McKinley, Bilirakis, Johnson, Barton, Upton (ex 
officio), Tonko, Green, DeGette, McNerney, Schakowsky, Barrow, 
Matsui, and Waxman (ex officio).
    Staff present: Nick Abraham, Legislative Clerk; Gary 
Andres, Staff Director; Charlotte Baker, Press Secretary; Sean 
Bonyun, Communications Director; Jerry Couri, Senior 
Environmental Policy Advisor; David McCarthy, Chief Counsel, 
Environment and the Economy; Brandon Mooney, Professional Staff 
Member; Chris Sarley, Policy Coordinator, Environment and the 
Economy; Alison Cassady, Democratic Senior Professional Staff 
Member; Greg Dotson, Democratic Staff Director, Energy and the 
Environment; Caitlin Haberman, Democratic Policy Analyst; and 
Elizabeth Letter, Democratic Press Secretary.
    Mr. Shimkus. I would like to ask the committee to come to 
order. I will now also recognize myself for 5 minutes for the 
purpose of doing an opening statement.

  OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF ILLINOIS

    Today marks our fifth hearing in this Congress on the Toxic 
Substances Control Act. Our focus today is on two sections in 
TSCA dedicated to getting EPA relevant testing data and other 
information on chemical substances in United States commerce. 
Past application of Section 4 by the EPA to obtain information 
about existing chemicals has been frustrated by judicial 
interpretation. We need to push beyond re-litigating those 
cases and focus on what authorities the EPA has now, or could 
reasonably use in the future to produce tailored, necessarily, 
and high-quality test data, and other information to carry out 
TSCA. We will also pick up on the discussion from the last 
hearing on standards for data quality, and the use of the best 
available science. The goal is credible decisions using high 
quality data. Information management will be one of the 
toughest areas to get right, but it is also one of the most 
important.
    I want to remind everyone that last summer former TSCA 
program director Charlie Auer testified before our committee 
that simply improving the way EPA is able to get information 
under Section 4 would have profound impact on improving TSCA's 
overall operation. Let us not kid ourselves, though; 
information collection and analysis on thousands of chemicals 
will become time consuming and very expensive. EPA will have to 
be smart and efficient to make this program work, especially 
when it comes to using available information, particularly 
exposure history, in deciding whether more testing is needed, 
and who should do the testing.
    Today's hearing will also focus on reporting for the 
thousands of chemicals in commerce. Section 8 requires the EPA 
to develop and maintain an inventory of all chemicals, or 
categories of chemicals, that are manufactured or processed in 
the United States. It also gives the EPA authority to require 
certain businesses involved with a chemical substance to 
maintain records and submit health and safety information 
report, particularly adverse health incidences caused by the 
chemical to the EPA.
    Within these reporting requirements, there are exemptions 
for polymers, microorganisms, and naturally occurring 
substances. We should find out if these make sense, and should 
be continued, and what the incremental gain, if any, in public 
health, resources, or protection occurs without these 
exemptions. We also need to focus on the definition of 
processor, and whether the definition is right-sized to the 
person's activities and information EPA is receiving.
    With that, I want to welcome our witnesses and thank them 
for their expertise and candor. We expect them to provide a 
variety of perspectives on when testing should be required, and 
what we can do to improve testing techniques so we can speed up 
analysis and reduce use of animals in that testing. We look 
forward to their views.
    And before I yield to the ranking member, I want to go off 
script and also thank you. I think, in our questions and 
response, candor is going to be important. There is a lot of 
excitement in trying to move a bill, and move it properly. And 
the other thing is, I was going back into the records, and I 
think 1976 is when this was authorized and put into law, and I 
had just graduated high school at that time, and started my 
first year in college. So, suffice it to say that probably a 
review and update of this law is timely, but we have to do it 
right. A lot of you all here will help us muddle through that 
process, and point out the good, and the bad, the ugly, and 
maybe, working with my colleagues, we could find areas of 
compromise.
    [The prepared statement of Mr. Shimkus follows:]

                Prepared statement of Hon. John Shimkus

    Today marks our fifth hearing in this Congress on the Toxic 
Substances Control Act. Our focus today is on the two sections 
in TSCA dedicated to getting EPA relevant testing data and 
other information on chemical substances in U.S. commerce.
    Past application of section 4 by EPA to obtain information 
about existing chemicals has been frustrated by judicial 
interpretation. We need to push beyond re-litigating those 
cases and focus on what authorities EPA has now or could 
reasonably use in the future to produce tailored, necessary and 
high-quality test data and other information to carry out TSCA.
    We'll also pick up the discussion from the last hearing on 
standards for data quality and the use of best available 
science. The goal is credible decisions using high quality 
data. Information management will be one of the toughest issue 
areas to get right, but it's also one of the most important.
    I want to remind everyone that last summer former TSCA 
program director, Charlie Auer, testified before our committee 
that simply improving the way EPA is able to get information 
under Section 4 would have profound impacts on improving TSCA's 
overall operation.
    Let's not kid ourselves, though; information collection and 
analysis on thousands of chemicals will become time-consuming 
and expensive. EPA will have to be smart and efficient to make 
this program work--especially when it comes to using available 
information, particularly exposure history, in deciding whether 
more testing is needed and who should do the testing.
    Today's hearing will also focus on reporting for the 
thousands of chemicals in commerce. Section 8 requires EPA to 
develop and maintain an inventory of all chemicals, or 
categories of chemicals that are manufactured or processed in 
the United States. It also gives EPA authority to require 
certain businesses involved with a chemical substance to 
maintain records and submit health and safety information 
reports, particularly adverse health incidences caused by the 
chemical, to EPA.
    Within these reporting requirements, there are exemptions 
for polymers, microorganisms, and naturally occurring 
substances. We should find out if these make sense and should 
be continued and what the incremental gain, if any, in public 
health resources and protection occurs without these 
exemptions. We also need to focus on the definition of 
processor and whether this definition is ``right-sized'' to the 
persons, activities, and information EPA is receiving.
    With that, I want to welcome our witnesses and thank them 
for their expertise and candor. We expect them to provide a 
variety of perspectives on when testing should be required and 
what we can do to improve testing techniques so we can speed up 
analysis and reduce use of animals in that testing. We look 
forward to their views.

    Mr. Shimkus. With that, I would like to yield to the 
ranking member of the subcommittee, Mr. Tonko, for 5 minutes.

   OPENING STATEMENT OF HON. PAUL TONKO, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF NEW YORK

    Mr. Tonko. Thank you, Mr. Chair, and good morning, and 
thank you for holding this hearing on the Toxic Substances 
Control Act, or TSCA. This is the subcommittee's fifth hearing, 
as we have been told, on this program. The hearings have been 
very instructive, and are providing us with a good foundation 
from which to evaluate the current law, and to develop 
legislation to improve it. Reform of this legislation is long 
overdue. I hope, Mr. Chair, that we will be able to work 
together and find common ground in this effort, which I think 
is critically important.
    The two sections of TSCA we are focusing on today, Section 
4, on chemical testing, and Section 8, on information reporting 
and retention, have not provided sufficient reliable 
information to support assessment and regulation of chemicals. 
The authorities provided to EPA in these sections are weak and 
cumbersome to implement. As a result, there is too little 
information gathered on the toxicity or environmental risks 
associated with chemicals, and the inventory of chemicals in 
commerce does not provide sufficiently detailed and 
contemporary data on the chemicals being used in the United 
States. Currently, the burden is on EPA to demonstrate that 
information is needed, rather than on industry to provide the 
information to demonstrate that their product has been 
adequately tested, and will present little risk when used 
properly.
    The tragic situation in Charleston, West Virginia 
demonstrates several failings of our chemical safety laws. Not 
all aspects of this incident can be blamed on the faults with 
TSCA, but the lack of information needed to respond to this 
situation illustrates the failure of this law. When the water 
supply for the people of Charleston, West Virginia was 
contaminated with chemicals that leaked from a storage tank, 
there was little reliable information to provide the public, 
emergency responders, or to the water company to guide their 
response actions. As a result, there was public confusion and 
concern about the advice offered by public officials and the 
water company. There was little understanding of the fate of 
the chemical in the water supply, or what health or 
environmental effects might result from the spill.
    This illustrates the importance of having adequate 
information to inform decisions about the protection of human 
health and our environment. Reform of TSCA must result in 
better information, and clear authority for EPA to act. The 
agency must have sufficient information to evaluate the risks 
of chemicals currently on the market, and basic information 
should be available before we have an accident, not slapped 
together in the midst of a crisis.
    The agency must be able to assess the risk of new chemicals 
before they enter into commerce. Dr. Paulson informs us, in his 
testimony, that a substantial portion of chemicals are known to 
have a wide range of adverse, and most irreversible, effects on 
child health. That is a prime warning. So it is important that 
we move forward with a law that recognizes that fact, and 
offers adequate protections for everyone.
    I look forward to the testimony of our witnesses today, and 
I thank you all for being here to share your views on what is a 
very important topic. And, again, I thank you, Mr. Chair, and I 
yield back.
    Mr. Shimkus. I thank my colleague. Now the Chair recognizes 
the chairman of the full committee, Mr. Upton, for 5 minutes.

   OPENING STATEMENT OF HON. FRED UPTON, A REPRESENTATIVE IN 
              CONGRESS FROM THE STATE OF MICHIGAN

    Mr. Upton. Well, thank you, Mr. Chairman. Today we are 
going to continue our examination of TSCA with a focus on the 
nuts and bolts of chemical information. For sure we want to 
develop a system for chemical regulation that is the gold 
standard for the rest of the world. It doesn't mean the most 
precautionary, or the most commercially free-wheeling. It means 
a balanced system rooted in the best science and highest-
quality information so that all of us can be confident that if 
a chemical is in our stream of commerce, it is safe, and 
commerce flows freely across State lines and across borders.
    The foundation of that confidence should be information, 
and that information must be grounded in rigorous science 
available for everyone to review, organized by category, and 
backed up by state-of-the-art testing when needed. The 
technology of testing has vastly advanced since 1976, and it 
will continue to evolve in a positive way. High power of 
computers will simulate and sort exposure date and analyze 
chemicals in batches by category so that time spent testing for 
biological effects, and the need to test on live organisms, is, 
in fact, reduced. We have also got to make sure that we don't 
go overboard and become obsessed with data collection for its 
own sake. There are thousands of chemicals in everyday life 
that are understood to pose no unreasonable risk when used as 
intended. We need to identify those based on information that 
we already have. Then we can focus our resources, information, 
development on the ones that we aren't so sure about. It is 
often said that the job of the manager is to know when to stop 
taking data, and start making decisions. That is the challenge 
for EPA under a reformed TSCA.
    It is also the challenge that we on the committee face as 
we transition from our examination of current law to developing 
our own ideas for how to modernize, after nearly 4 decades, 
this body of regulation. So I look forward to working with 
every one of our committee members as we set out on that path. 
And I have every confidence in you, Mr. Shimkus, to chart a 
successful course to get this job done. Really, I do. And I 
also appreciate the leadership of Mr. Waxman, and Mr. Tonko, 
and every member of this subcommittee for the hard work that 
they have put in.
    We need to chart a path that, yes, not only will reach the 
House floor, but ultimately reach the President, and it needs 
to happen this year. All of us have stayed focused through 
these hearings and developed the policy expertise that will 
benefit each of us in our deliberations. It is hard work that 
attracts little publicity, but in the long run, our world is 
certainly going to be better for it. And I yield back.
    [The prepared statement of Mr. Upton follows:]

                 Prepared statement of Hon. Fred Upton

    Today we continue our examination of TSCA with a focus on 
the nuts and bolts of chemical information. We want to develop 
a system for chemical regulation that is the gold standard for 
the world.
    That doesn't mean the most precautionary, or the most 
commercially free-wheeling. It means a balanced system rooted 
in the best science and highest quality information so we can 
all be confident that if the chemical is in our stream of 
commerce it is safe, and commerce flows freely across State 
lines and across borders.
    The foundation of that confidence should be information. 
And that information must be grounded in rigorous science, 
available for everyone to review, organized by category, and 
backed up by state-of-the art testing when needed.
    The technology of testing has vastly advanced since 1976 
and it will continue to evolve. High power computers will 
simulate and sort exposure data and analyze chemicals in 
batches, by category, so that the time spent testing for 
biological effects and need to test on live organisms is 
reduced.
    We've also got to make sure we don't go overboard and 
become obsessed with data collection for its own sake. There 
are thousands of chemicals in everyday life that are understood 
to pose no unreasonable risk when used as intended. We need to 
identify those, based on information we already have. Then we 
can focus our resources and information development on the ones 
we aren't so sure about.
    It's often said that the job of the manager is to know when 
to stop taking data and start making decisions. That's the 
challenge for EPA under a reformed TSCA.
    It's also the challenge we on the committee face as we 
transition from our examination of current law to developing 
our own ideas for how to modernize, after nearly four decades, 
this body of regulation. I look forward to working with all of 
our committee colleagues as we set out on that path.
    Thank you, Chairman Shimkus, Mr. Tonko, and all the 
subcommittee members for the hard work you've already put in. 
You've stayed focused through these hearings and developed the 
policy expertise that will benefit each of us in our 
deliberations. It's hard work that attracts little publicity, 
but in the long run, our world will be better for it.

    Mr. Shimkus. The gentleman yields back his time. I want to 
make sure I get that clip and send it to my spouse, so that she 
knows that I am working----
    Mr. Upton. And your high school science teacher.
    Mr. Shimkus. No, I don't want to go there. Now, and this 
will be the first of many times that we get to recognize the 
ranking member, but, being the first one, I want to 
congratulate Henry on his announcement. I don't expect him to 
go away quietly. I do expect involvement after Congress still 
with us and our issues. But, with that, let me yield 5 minutes 
to the ranking member and chairman emeritus, Mr. Waxman, for 5 
minutes.

OPENING STATEMENT OF HON. HENRY A. WAXMAN, A REPRESENTATIVE IN 
             CONGRESS FROM THE STATE OF CALIFORNIA

    Mr. Waxman. Thank you very much, Mr. Chairman. I am going 
to also give you a clip that you can share with your family, 
because I agree with Chairman Upton. This is a time for us to 
work together, and I want to work with you on reform of the 
Toxic Substances Control Act. I believe TSCA is a flawed law 
that must be updated, and we need to work together to do this.
    Last month, State and Federal officials in West Virginia 
were left scrambling when they could not find meaningful health 
and safety data on a chemical that had polluted the drinking 
water of 300,000 people. This disaster illustrated some serious 
problems with the current law. New chemicals enter the market 
without basic toxicity data. Untested chemicals remain on the 
market, and chemical manufacturers often are not required to 
submit tests that they do to EPA. This is an area ripe for 
Congressional action, and holding a serious of hearing is a 
step in the right direction.
    But we also need to start bipartisan talks to see if we can 
reach a compromise that protects the public from dangerous 
toxic chemicals without unduly burdening industry. It is an 
open secret that the majority staff is drafting a TSCA bill, 
but at this point, they have shared nothing with the staff on 
our side of the aisle. They haven't shown us language, or 
explained their concepts for TSCA reform. Of course, Mr. 
Chairman, this is your prerogative, but the reality is that an 
unbalanced proposal simply isn't going to become law.
    The Senate also has drafted a proposal for TSCA reform. The 
chemical industry strongly supports it, but the public interest 
community is deeply concerned about the proposal. We need to 
strengthen TSCA, yet most environmental groups believe that the 
Senate draft would actually weaken the current law. This looks 
like a recipe for a stalemate, and we don't need too many 
recipes for a stalemate. We get stalemates all the time without 
a recipe.
    If we are going to succeed, however, in reaching a 
compromise that will become law, we need a formulation that 
both sides, industry and environmentalists, can support, and I 
think there is a way we can achieve this. It is not commonly 
known, but in 2011 the American Chemistry Council, representing 
industry, and the Safer Chemicals Health Family Coalition, 
representing public health groups, sat down to see if they 
could find common ground on TSCA reform. They found many areas 
of agreement, and documented the agreement in a memorandum 
prepared by the Meridian Institute. I believe this consensus 
between industry and public health groups could be a basis for 
productive discussions in this committee.
    Later today I will be sending a letter to these groups and 
requesting they share their results with our committee. And, 
Mr. Chairman, I would like to invite you to join me in sending 
this letter. The result of their careful policy discussions 
just might be a blueprint for success in our committee.
    In recent days I have been asked a lot about my views of 
Congress, particularly since I announced I am leaving. Now 
people want to know what I think about Congress. Well, I have 
said that although there are aspects of Congress today that I 
strongly dislike, I remain convinced that Congress can still be 
a powerful force for good for our Nation. I hope we can 
demonstrate that once again by working together on TSCA reform. 
Only when we work together do we see successful legislation all 
the way through to the President's signature. That is what we 
need to do, initiate successful legislation in this committee, 
and see it all the way through. We have a history of that in 
our committee, and I hope we can go back to that pattern again. 
Thank you, Mr. Chairman. Yield back my time.
    Mr. Shimkus. Gentleman yields back his time. Now, again, 
the Chair, I would like to welcome you all here. You will all 
be given 5 minutes for your opening statement. Your full 
statements will be recorded into the record. So we will start 
from left to right. We will start with Mr. Charles Drevna, 
President of the American Fuel and Petrochemical Manufacturers. 
You are recognized for 5 minutes. Welcome.

  STATEMENTS OF CHARLES T. DREVNA, PRESIDENT, AMERICAN FUEL & 
PETROCHEMICAL MANUFACTURERS; ROBERT A. MATTHEWS, MCKENNA, LONG 
 & ALDRIDGE, LLP, ON BEHALF OF THE CONSUMER SPECIALTY PRODUCTS 
ASSOCIATION; BRENT GRAZMAN, VICE PRESIDENT, QUALITY ASSURANCE, 
   VIASYSTEMS GROUP, INC., ON BEHALF OF IPC-THE ASSOCIATION 
 CONNECTING ELECTRONICS INDUSTRIES; BETH D. BOSLEY, PRESIDENT, 
    BORON SPECIALTIES, ON BEHALF OF THE SOCIETY OF CHEMICAL 
  MANUFACTURERS AND AFFILIATES; CATHERINE WILLETT, DIRECTOR, 
 REGULATORY TOXICOLOGY, RISK ASSESSMENT, AND ALTERNATIVES, THE 
  HUMANE SOCIETY OF THE UNITED STATES; JENNIFER SASS, SENIOR 
   SCIENTIST, NATURAL RESOURCES DEFENSE COUNCIL; AND JEROME 
  PAULSON, CHAIRPERSON, EXECUTIVE COMMITTEE OF THE COUNCIL ON 
      ENVIRONMENTAL HEALTH, AMERICAN ACADEMY OF PEDIATRICS

                 STATEMENT OF CHARLES T. DREVNA

    Mr. Drevna. Chairman Shimkus, Ranking Member Tonko, and 
Full Committee Chair Mr. Upton, and Mr. Waxman, members of the 
subcommittee, I am Charlie Drevna, President of American Fuel 
and Petrochemical Manufacturers. As the name implies, AFPM 
represents high tech manufacturers. While most people are 
familiar with the fuels they use every day, many are not 
familiar with the petrochemicals. Petrochemicals are the 
industrial building blocks that make the materials, 
ingredients, and processing agents that appear throughout a 
variety of manufacturing supply chains. Whether it is the 
plastic casing of your cell phone, excuse me, the aspirin in 
your medicine chest, or even the helmet worn by a loved one in 
the military, petrochemicals, such as ethylene and propylene 
play a critical role in manufacturing, and in our lives every 
day.
    TSCA is a unique statute in that it has much to do with 
commerce and the manufacturing supply chain as it does with 
human health, and the environment. TSCA gives the EPA broad 
power to regulate chemicals in commerce. While AFPM supports 
rational modernization of TSCA, great care must be taken so 
that the manufacturing supply chains are not disrupted. This is 
one statute where our members believe that a strong Federal 
role is required to maintain the interstate flow of raw 
materials and goods.
    Since its enactment in 1976, we have learned that the 
implementation of TSCA has been challenging for EPA in certain 
areas, and there is still debate over whether the challenges 
have been due to the statute, or due to some of the choices the 
agency has made. I believe it is time to take a fresh look at 
how we control chemicals in commerce, and again try to strike 
that balance between helping the environment, and a globally 
competitive manufacturing supply chain.
    The U.S. is on the brink of a manufacturing renaissance, 
due in large part to dramatic reductions in the cost of energy 
and raw materials. Shale development has fostered the most 
globally competitive positioning for American manufacturers I 
have ever witnessed. Given this opportunity, when it comes to 
laws that affect the feed stocks driving the manufacturing 
renaissance, we must get TSCA modernization right. To begin, 
AFPM supports a bipartisan effort to modernize TSCA. That means 
a new starting point for discussion, and a constructive 
dialogue. I echo Mr. Waxman's comments there. The current TSCA 
statute provides a solid backbone for chemical regulation, but 
AFPM does see room for improvement.
    One area for improvement is more guidance from Congress 
that directs the EPA to prioritize chemicals in commerce. AFPM 
views prioritization efforts under the Canadian chemical 
management program as a reasonable, achievable model. The 
approach used in Canada is a screening level look at chemical 
hazard and exposure to tell scientists whether or not more work 
is needed to deem a substance safe for its intended use, and 
the conditions of that use. Currently the EPA has sophisticated 
and protective models that it uses to evaluate the potential 
hazards of chemicals. The agency collects data under the 
chemical data reporting rule to determine the exposure 
potential of chemical substances. So there are no technical or 
practical reasons that EPA cannot prioritize chemicals for 
further work.
    Congress should also include provisions that increase 
scientific quality and transparency at the agency. Specific 
language should require EPA to develop criteria by which the 
agency and public can judge the quality of scientific studies 
under consideration, as well as EPA risk assessments.
    An important part of TSCA is Section 4, which authorizes 
the EPA to require laboratory testing of certain chemicals. I 
tend to agree that under Section 4, the prerequisite for EPA to 
find a risk posed by a chemical before it can require testing 
for that chemical does not make sense. The exposure finding, on 
the other hand, is a built in check and balance to prevent EPA 
from demanding unreasonable animal intensive tests that will 
not lead to a further and better understanding of safety. AFPM 
firmly believes that there should be an exposure basis before 
EPA can require animal testing.
    AFPM's highest level principles state that TSCA should be a 
tiered, targeted, and risk based approach. This is especially 
true for testing and data collection. A tiered approach begins 
with the use of existing information, protective models, and 
structure activity relationships. If there is an unreasonable 
amount of scientific uncertainty at a screening level, then the 
substance would be subject to the next tier, in which 
information is collected to reduce the uncertainty.
    When it comes to Section 8, which authorizes the EPA to 
collect information that provides an accurate reflection of 
chemicals to commerce, Congress should also provide specific 
guidance. For example, the chemical data reporting rule, EPA is 
required for producers to use exposure information.
    In closing, there are other sections of TSCA that may need 
updating, but I am confident that the subcommittee will address 
those issues at a later date. Thank you Mr. Chairman, Ranking 
Member Tonko, and subcommittee members for allowing us the 
opportunity to express our views.
    [The prepared statement of Mr. Drevna follows:]


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    Mr. Shimkus. Thank you, Mr. Drevna. Now the Chair 
recognizes Mr. Robert Matthews from McKenna, Long, and 
Aldridge, on behalf of the Consumer Specialty Products 
Association. Sir, you are recognized for 5 minutes.

                STATEMENT OF ROBERT A. MATTHEWS

    Mr. Matthews. Thank you. Good morning, Mr. Chairman, 
Ranking Member Tonko, members of the committee. It is a 
pleasure and privilege to appear before this committee on 
behalf of the Consumer Specialty Products Association. It is 
our firm's oldest client. We have been representing their 
interests for over 5 decades. So it is my privilege to appear 
on their behalf, and before your subcommittee.
    In fact, this year CSPA celebrates its 100-year anniversary 
serving as the premiere trade association representing the 
interests of companies both large and small. A good half of 
their companies are small businesses, the companies that 
formulate and market household and institutional products.
    In our written testimony, and in my comments today, we 
refer to our members as formulators, which is a segment of the 
downstream companies that are more generally referred to as 
processes. CSPA and its member companies have consistently 
advocated for the need to update the TSCA statute, and, 
importantly, recognize the role of downstream formulators in 
that process. CSPA's role and interest in TSCA is to assure the 
process is working in a way that protects public health and the 
environment, allows companies to continue to operate 
effectively and efficiently in commerce, and maximizes consumer 
confidence in chemical safety, and by extension, in the branded 
products that we place on the market.
    CSPA's support for modernizing TSCA is rooted in three 
principle considerations. First, it is critical, as I just 
mentioned, that consumers have confidence in these formulated 
products. Maintaining that high level of confidence in the 
safety of chemicals used in their products placed on the market 
is of utmost concern to CSPA and its member companies.
    Second, CSPA member companies who sell formulated household 
and institutional products increasingly face a multitude of 
State regulations, indeed, not only at the State, but at the 
local level, as legislative and regulatory entities are simply 
not waiting for Congress to act to modernize this statute. So 
we support modernization because it will create a more 
predictable environment in which companies can engage in 
interstate commerce.
    And, finally, among the reasons we have continually 
supported changes and modernization of TSCA is because our 
companies, like others in industry, are impacted by the 
adoption and globalization of the EU Reach program, with its 
focus on regulation by hazardous properties of chemicals, and 
its calls for massive data into the system that is often 
unnecessary, costly, and burdensome. We think this is an 
opportunity for the United States to assert its leadership in 
establishing risk based global chemical management programs.
    So I am now, with that background, pleased to share with 
you our very specific thoughts on how CSPA and its member 
companies can meaningfully participate in the TSCA statute that 
would emerge after modernization. So we have focused in 
particular on the issues that impact our members. Those include 
in particular one that is before this committee today. That is 
Section 8, and the reporting provisions thereunder. We have 
also focused considerable attention on the confidential 
business information, or CBI, provisions of Section 14. So I 
will largely focus on Section 8, as this committee has 
requested, and the impact of that section on the prioritization 
program under Section 4.
    The key to a modernized TSCA is an affirmation of a risk 
based chemical management system, meaning that at the time that 
EPA is prioritizing chemicals for review, and setting 
standards, they are focused not only on the hazard, or 
intrinsic properties of that chemical, but the manner in which 
those chemicals are used, and the potential exposures that they 
create.
    But as it supports a risk based approach, CSPA has also 
recognized three related points. First, indeed, a risk based 
system starts with prioritization, where EPA screens chemicals 
in commerce to identify which ones should be subject to further 
review, and potentially to a safety assessment. Given the large 
number of chemicals in process, it is imperative that there be 
an effective screening process. Second, to properly screen, and 
indeed, again, potentially to conduct risk assessments, EPA 
must have information on how those chemicals are being used, 
and their potential exposure scenarios that they crate. And 
that leads to the third point, which is EPA has to have to have 
the means to get that information from where that information 
lies, which is principally with the downstream community, who 
know much more about use and exposure than do the raw material 
manufacturers.
    So the role of formulators under a revised TSCA, therefore, 
can be very much defined and targeted for that purpose. We have 
spent considerable time focusing on the elements that would be 
useful in that regard that would impact our member companies. 
So we have done so in a manner that aligns what we think is 
EPA's needs at the prioritization stage with the information 
that we have. So we would propose to submit to the agency 
information that involves chemicals that will be placed in 
products, information on chemicals that are placed in products 
intended for use by children, information on the concentration 
range of the chemicals in those products, and, indeed, the 
number of workers, that is, who are involved in formulating 
those materials. Combined with the hazard materials, that is to 
say the hazard information, that EPA would have from the 
chemical producers, this would give EPA all that it needs in 
regard to prioritization.
    So I have much more to say about confidential business 
information. Perhaps that will come up, but that is the 
principle focus of our efforts, is to get that kind of use and 
exposure information into the agency. Thank you.
    [The prepared statement of Mr. Matthews follows:]


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    Mr. Shimkus. Thank you. Now the Chair recognizes Dr. Brent 
Grazman, Vice President for Quality Assurance, Viasystems 
Group, Incorporated, on behalf of the IPC, Association 
Connecting Electronics Industries, and more importantly from 
the St. Louis Metropolitan area, which is where I reside. So 
with that, welcome. You are recognized for 5 minutes.

                   STATEMENT OF BRENT GRAZMAN

    Mr. Grazman. Thank you, Mr. Chairman, and members of the 
committee for the opportunity address you today. Viasystems is 
a global manufacturer of printed circuit boards. We are 
headquartered, as the Chairman mentioned, in St. Louis. We 
employ over 2,000 people in the U.S. in eight different 
factories, including North Jackson, Ohio, and Littleton, 
Colorado. We make printed circuit boards that are used by 
leading manufacturers of transportation, telecommunications, 
medical, defense, and aerospace products.
    I am also here to represent IPC, the Association Connecting 
Electronics Industries. IPC is a global trade association 
representing over 2,000 electronics manufacturers in the U.S. 
As a member of IPC's government relations committee, I want to 
emphasize that IPC and its members, including Viasystems, are 
all strong advocates for science-based regulation that improves 
the environment, protects human health, and stimulates the 
economy. In my testimony I will highlight our concerns about 
TSCA Section 8 as it applies to byproducts reporting.
    It is critical that Congress reform TSCA in a way that 
directs the Environmental Protection Agency to focus and 
prioritize its regulation of chemicals. Selection of priority 
chemicals should be based on sound science. Substances that 
exhibit the greatest hazard and impose the greatest exposure to 
consumers should be given priority for review for testing, and 
as needed for regulation. A targeted, prioritized approach will 
allow the EPA and industry to both more effectively use our 
limited resources to protect human health and the environment.
    An example of EPA's failure to prioritize chemical 
regulation is the treatment of byproducts. Under TSCA, the EPA 
treats byproducts as new chemicals if they are sent for 
recycling. But if we sent them for disposal, there is no TSCA 
requirement invoked. As a new chemical, the byproduct sent for 
recycling must be listed on the TSCA inventory, and is subject 
to the full regiment of TSCA recordkeeping, reporting, and 
enforcement. Let me emphasize all of these regulatory 
obligations arise solely because a manufacturer, like 
Viasystems, sends a byproduct for recycling, rather than just 
disposing of it.
    TSCA contains specific exemptions for byproducts, but the 
EPA has narrowly interpreted these exemptions to apply only if 
the recycler does not use a chemical reaction to recover 
substances from the byproduct. Recovery of metals, like gold, 
tin, and copper, that are in our byproducts is impossible 
without the use of the chemical reaction. We manufacture 
printed circuit boards like this one. We don't manufacture 
chemicals.
    The EPA requires us to know, at a molecular level, what the 
recyclers of our byproducts do with our byproducts. The 
recycler's processes are outside of our control. They are often 
proprietary, and they can change day to day, based on the 
market conditions that those recyclers see. The result is a 
regulatory policy that forces companies to report data based on 
incomplete information and assumptions, ultimately compromising 
the data quality. EPA's overreaching interpretation affects a 
lot more facilities and companies than those represented by the 
IPC. Manufacturers from many industries are burdened by 
reporting their byproducts as new chemicals at the point when 
they send them for recycling.
    Much of the data that we repot about byproducts under TSCA 
is also required by the Resource Conservation and Recovery Act, 
and the Emergency Planning and Community Right to Know Act. 
Under TSCA, the recyclers are required to report the new 
chemicals they manufacture from our byproducts. The EPA 
unnecessarily burdens industry with the reporting of vast and 
duplicative data for some unknown future uses.
    As a Nation, we recognize reduce, reuse, and recycle as 
goals. The EPA undercuts those goals with regulatory policy 
that effectively discourages us from recycling. We encourage 
Congress to explicitly exempt all byproducts, including those 
that are sent for recycling. As I mentioned earlier, we 
manufacture printed circuit boards, not chemicals. The focus of 
TSCA, pardon me, should remain on ensuring the safety of 
chemicals in commerce. EPA's authority to regulate articles, 
like printed circuit boards, should be limited to situations 
where regulating the chemicals themselves is not enough to 
protect human health and the environment.
    In conclusion, IPC supports cost effective, science based 
environmental regulation. As I have discussed, it is critical 
that Congress reform TSCA in a way that directs the EPA to 
focus and prioritize its regulation of chemicals. We believe 
that EPA's reporting requirements for byproducts sent for 
recycling are burdensome, unnecessary, and, as I mentioned, 
they actually discourage recycling.
    Thank you again for this opportunity to appear before you. 
I will be happy to answer any questions when the time is right.
    [The prepared statement of Mr. Grazman follows:]


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    Mr. Shimkus. Thank you, sir. Now the Chair recognizes Dr. 
Beth Bosley, President, Boron Specialties, on behalf of the 
Society of Chemical Manufacturers and Affiliates. You are 
recognized for 5 minutes. Welcome.

                  STATEMENT OF BETH D. BOSLEY

    Ms. Bosley. Good morning, Chairman Shimkus, Ranking Member 
Tonko, and members of the subcommittee. I am pleased to 
testify----
    Mr. Shimkus. Can you just pull that microphone just a 
little bit closer to you?
    Ms. Bosley. There we go. I am pleased to testify once again 
on behalf of the Society of Chemical Manufacturers and 
Affiliates regarding TSCA today on Section 4 and Section 8. 
Just a background on SOCMA, over 80 percent of our members are 
small businesses. For example, my business just hired its 
eighth employee. Even with that small staff, we are committed 
to responsibly manufacturing our products here in the United 
States. We produce unique chemicals by novel manufacturing 
techniques that are used in the electronics, aerospace, and 
nuclear energy sectors.
    SOCMA members' unique niche in the chemical industry is 
known for its innovation, entrepreneurship, and customer focus. 
I would like to begin by saying that SOCMA remains committed to 
strengthening TSCA, and appreciates the subcommittee's work in 
this aspect.
    We should avoid approaches to TSCA reform that would treat 
the vast universe of TSCA chemicals like the far narrower 
universes of food additives, drugs, and pesticides. In 
particular, the sheer number of new chemicals that are 
submitted to EPA each year, and the evolving market needs, mean 
that use by use approvals make sense for drugs and pesticides 
will not work for industrial chemicals in general. A TSCA 
reform bill should be fundamentally risk based, as you have 
heard from other witnesses at the table, and it should require 
EPA to look at a chemical's inherent hazards, along with its 
exposures, when making regulatory decisions.
    An improved Section 4 should be tiered, targeted, and risk 
based. Generally stated, the real problem with TSCA has been 
the treatment of existing chemicals. Section 4 gives the EPA 
authority to require testing of existing chemical substances 
and mixtures once certain criteria are met. In this section, 
that allows EPA to obtain measured data on existing chemicals 
of currently available data and experience, are insufficient to 
reasonably predict their effects.
    The major shortcoming in this section is actually 
procedural. EPA is required to go through a rulemaking process, 
which has contributed to delays in EPA getting the data that 
they need. For example, EPA has taken years to finalize a 
number of high production volume chemical test rules, even 
though the industry has strongly supported such test rules. 
Voluntary efforts and enforceable consent agreements have 
helped streamline the testing process, but this section of TSCA 
could be strengthened by considering authorization for EPA to 
issue orders similar to the way it issues orders for new 
chemicals.
    Any orders for testing approaches should be tiered and 
targeted. That is, they should start off at a screening level, 
and focus the testing where the risk is greatest. A screening 
level analysis may show that hazard is sufficiently low that 
additional test data will not be necessary. The same goes for 
scenarios where exposures are highly unlikely. We support the 
notion that EPA should have to abide by basic standards of 
scientific quality, and specify in accepting screening and 
testing data. We also believe alternatives to animal testing 
should be supported, where they are sufficient validated.
    The second major shortcoming of Section 4 is the lack of 
any requirement that EPA act on a specific number, or a 
percentage of existing chemicals, by any particular time. 
Congress should remove obstacles to more comprehensive EPA 
evaluation of inventory chemicals by mandating EPA to review a 
minimum number of chemicals annually via a risk-based 
prioritization process. We believe EPA has the expertise to do 
this. There are very talented scientist and engineers at EPA. 
Unfortunately, they don't have the resources to do that at this 
time. Reforms to Section 8 could give EPA a better 
understanding of the exposure scenarios and able it to 
prioritize more efficiently.
    As mentioned above, testing of existing chemicals, should 
be tiered, targeted, and risk-based. Improvements to TSCA 
Section 8 could help EPA determine whether an existing chemical 
warrants testing. One way Section 8 could be improved is by 
requiring an inventory reset to ensure that the inventory of 
existing chemicals is current. This effort will also pare down 
the initial number of chemicals to be evaluated. It is a 
concept we have supported for many years, and believe it is a 
vital first step to a robust and efficient existing chemicals 
policy.
    Another significant problem with Section 8 is that it does 
not authorize EPA to collect use or exposure information from 
anyone downstream of manufacturers or processors. The result is 
that, in many cases, manufacturers are forced to make educated 
guesses about the end use markets and exposure scenarios 
surrounding the use of their products. SOCMA would like to see 
an expansion of this section to allow collection of information 
from non-consumer downstream entities.
    Finally, we urge you to amend Section 8(e) to authorize 
manufacturers, processors, and commercial downstream 
distributers and users to file reports with the EPA regarding 
non-adverse findings about chemicals. Currently there is no 
mechanism to report such non-adverse date. The result is that 
the public database on existing chemicals is unnecessarily 
limited and biased toward the bad news. With reasonable 
amendments, TSCA could provide an easier mechanism to submit 
such information.
    As I conclude, it is important to mention that the 
Lautenberg-Vitter Chemical Safety Improvement Act introduced 
into the Senate last year is a remarkable example of well-
reasoned bipartisan TSCA legislation, and we endorse it as a 
vehicle for reform. The subcommittee should be able to leverage 
much of the work done there, including the work on Sections 4 
and 8. Thanks for this opportunity. I will be happy to answer 
any questions.
    [The prepared statement of Ms. Bosley follows:]


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    Mr. Shimkus. Thank you. And before I go to Dr. Willett, we 
did have Senator Vitter and the new co-sponsor, Senator Udall, 
here for a hearing on this bill, and we applaud their work, and 
look forward to building on that.
    The chair now recognizes Dr. Catherine Willett, Director of 
Regulatory Toxicology Risk Assessment and Alternatives from The 
Humane Society of the United States of America. Welcome, and 
you are recognized for 5 minutes.

                 STATEMENT OF CATHERINE WILLETT

    Ms. Willett. Thank you, Chairman Shimkus and Ranking 
Member----
    Mr. Shimkus. Pull that mike just a little bit closer to 
you, because we want everyone to hear you.
    Ms. Willett. OK. Thank you. Thank you, Chairman Shimkus, 
and Ranking Member Tonko, for the opportunity to testify on 
behalf of The Humane Society of the United States, the Humane 
Society Legislative Fund, two members of the Nation's largest 
animal protection organization. We strongly support animal 
protection, and also public health and environmental safety for 
the animals that are in our environment, and we believe that 
the Environmental Protection Agency should have the tools 
necessary to appropriately regulate chemicals in the United 
States.
    I am excited to be here to discuss the opportunities for 
21st century science to impact Section 4 of the Toxic 
Substances Control Act. I have been a bench scientist for 20 
years, and some of those years I was a practicing toxicologist. 
For the past 7 years I have worked internationally on chemicals 
policy.
    As mentioned by Chairman Upton, the science that underpins 
chemical characterization has undergone a radical 
transformation in recent years, as outlined in a 2007 report by 
the National Research Council, and which has also been taken up 
by EPA in their recent strategic plans. The report's conclusion 
is that reduced reliance on whole animal testing leads to a 
more relevant and efficient toxicity testing paradigm, 
resulting in increased protection for humans and the 
environment.
    Rather than relying on a rote battery of animal tests, this 
new approach involves an iterative process of chemical 
characterization, toxicity testing, and extrapolation modeling, 
informed by population based data and human exposure 
information. This transformation is in response to challenges 
the EPA has experienced in obtaining data on the tens of 
thousands of chemicals to which people and the environment are 
potentially exposed, and in accommodating increasingly complex 
issues, for example, life stage susceptibility, the effect of 
mixtures, varying exposure scenarios, and cumulative risk.
    Any effective modification of TSCA must allow for, and 
encourage, adoption of these evolving strategies. By 
articulating this in any legislative proposal, Congress will 
also send a strong message that more effective chemical 
regulation is dependent on more effective, and humane, 
chemicals testing. To do this, we urge Congress to be mindful 
of the following considerations. As also mentioned by Chairman 
Upton, computational cell and tissue based methods can now be 
used to prioritized chemicals, or groups of chemicals, that are 
of primary concern. These methods can also be used to satisfy 
information needs in some cases for some chemicals. Further 
development and application of these methods for use in risk 
assessment should be encouraged.
    Updated legislation should be flexible enough to allow the 
inclusion of new testing methods and strategies as they are 
developed. New legislation should provide EPA with significant 
commitment for creating the necessary infrastructure to do 
this. New legislation should also offer strong incentives for 
companies to fund, develop, and use new methods and testing 
strategies. And, as non-animal alternative methods become 
available, the use of such methods should be required in place 
of animal tests. We foresee a time when the principle of animal 
testing is a last resort.
    Protecting human health and the environment is a critical 
goal of effective chemicals regulation. In order to achieve 
this goal, it is necessary for any new legislation to allow and 
support the continuing evolution of the science of chemical 
assessment. The Humane Society of the United States hopes that 
we will have the opportunity to work with you on any 
legislative language to reauthorize aspects, or the entirety of 
TSCA. Thank you very much.
    [The prepared statement of Ms. Willett follows:]


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    Mr. Shimkus. Thank you. The Chair now recognizes Dr. 
Jennifer Sass, Senior Scientist, National Resources Defense 
Council. You are recognized for 5 minutes. Welcome.

                   STATEMENT OF JENNIFER SASS

    Ms. Sass. Thank you very much, Chairman Shimkus, and 
Ranking Member----
    Mr. Shimkus. Also, just pull that, there you go.
    Ms. Sass. Closer? OK.
    Mr. Shimkus. And if you can point the microphone to where 
your mouth is?
    Ms. Sass. Nobody ever complains about not hearing me, so I 
want----
    Mr. Shimkus. Well, our transcribist was freaking out over 
there, so----
    Ms. Sass [continuing]. It on record. Thank you for the 
invitation to be here, and to testify on this very important 
issue. As Mr. Waxman stated in his opening comments, TSCA is a 
statute that has failed to protect the public, and that is 
certainly true of its provisions regarding testing and data 
collection, which we are here to discuss today. TSCA needlessly 
impedes the collection of such information, with predictable 
results.
    In the wake of the recent spill in West Virginia, the 
impact of the information gaps in TSCA are more visible. The 
leaking of 4-methylcyclohexanemethanol, the MCHM, and other 
chemicals into the Elk River in West Virginia brought home, 
literally into peoples' homes, the disturbing reality that no 
useful information is available to the public, or those who 
serve them. In fact, a Pugh Health Group research fact sheet 
put out in 2010 found that roughly 3,000 chemicals used in over 
one million pounds annually in the U.S., these are the HPV, or 
high production volume chemicals, may have no information 
regarding potential developmental or pediatric toxicity. 
Nonetheless, over 700 of them are used in consumer products. 
CDC bio-monitoring has found over 200 synthetic chemicals in 
the blood and urine of Americans.
    TSCA provisions set an excessively high bar that has 
effectively prevented EPA from getting information. First EPA 
must essentially prove that a chemical poses an unreasonable 
risk to health or the environment before it can require the 
needed testing that would show a potential risk. This is like 
requiring a doctor to prove that a patient has cancer before 
being able to order a biopsy. It is a catch-22 construction of 
EPA's testing authority that has greatly constrained the agency 
from getting data through testing in a timely manner. Second, 
to require testing of existing chemicals, EPA must complete a 
full formal rulemaking. Other programs, including the pesticide 
program, and even TSCA's new chemical program, instead allow 
EPA to require testing by issuing an order, which is a much 
more streamlined process.
    As a result of these systems of hurdles and procedural 
hurdles, in the nearly 40 years since TSCA's enactment, EPA has 
required a full set of testing data on only a few hundred of 
the 62,000 grandfathered chemicals that came in under the law 
in 1976. The good news is that the flaws in Section 4 of TSCA 
can be resolved relatively easily by eliminating the catch-22 
provisions of Section 4 and allowing the agency to require 
testing by order, rather than by rule, the bottleneck would 
largely be eliminated, and the agency would begin to get more 
information in a timely manner necessary to inform and protect 
the public.
    The failure of TSCA, and the subsequent action at the State 
level to collect information, and to limit the use of harmful 
chemicals, has prompted renewed discussion of TSCA reform, 
which is useful, but the Chemical Safety Improvement Act, S 
1009, as introduced will not solve the problems with current 
TSCA, and in some respects, will make things worse. The 
introduced bill would prevent EPA from requiring testing for a 
chemical until it has already been identified as a high 
priority substance. This essentially replicates the existing 
catch-22. EPA would generally need evidence of hazard or 
exposure for a chemical to be designated high priority in the 
first place. Although EPA would be allowed to require testing 
for high priority chemicals by order, the universe of potential 
chemicals for which EPA could require testing would likely be 
greatly reduced.
    We also need more detailed use and exposure information for 
chemicals, as has been mentioned by other speakers, beyond what 
is currently captured in EPA's chemical data reporting rule. 
Unfortunately, the chemical industry has routinely failed to 
provide updated production use and exposure data, and 
strenuously resisted government action to collect it.
    Various proposals have been made to reset the TSCA 
inventory as part of TSCA reform. If this is undertaken, 
Congress should not in any way delay efforts currently underway 
to take expedited action on substances, such as chemicals that 
are PBTs, the persistent bio-cumulative and toxic ones, or 
other chemicals for which we already have sufficient 
information to know that they are unsafe, or slow, for example, 
EPA's current efforts to review its work plan chemicals.
    Second, if a substance is taken off the TSCA inventory, it 
should not be able to re-enter the inventory without going 
through a review process. A disturbing example is the 
firemaster 550, which ended up back in products, and in blood 
and breast milk. It is possible to have a balanced information 
regime that would protect the public, while helping industry by 
increasing public confidence in its products. The committee can 
play a critical role in this, and we are happy to work on that, 
but we are not there now.
    Thank you.
    [The prepared statement of Ms. Sass follows:]


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    Mr. Shimkus. Thank you. And last, but not least, we have 
Dr. Jerry Paulson, who is the chairperson of the Council on 
Environmental Health, Department of Federal Affairs, American 
Academy of Pediatrics. Sir, you are welcome, and you are 
recognized for 5 minutes.

                  STATEMENT OF JEROME PAULSON

    Mr. Paulson. Good morning, Chairman Shimkus, and Ranking 
Member Tonko, and members of the subcommittee. Thank you for 
this opportunity to testify today about the testing and data 
collection requirements under the Toxic Substances Control Act 
of 1976. I am Dr. Jerome Paulson, and I am here representing 
the American Academy of Pediatrics, a non-profit professional 
organization of 60,000 pediatricians dedicated to the health, 
safety, and well-being of infants, children, and adolescents. 
As mentioned, I currently serve as the chair of the AEP's 
council on environmental health. I will summarize my written 
statement, a full copy of which I have submitted for the 
record.
    Chemical management reform is an important policy that 
uniquely impacts children's health. Children are not little 
adults. They have unique physiologic, behavioral, and 
developmental differences that amplify their exposure to 
chemicals in the environment. For example, infants may be 
exposed to contaminants in water used in formula preparation. 
Nobody else drinks formula. Toddlers engage in normal mouthing 
behaviors, where they put objects into their mouths, that may 
expose them to dangerous toxins. Children spend more time on 
the floor, or the ground, and come into more contact with 
contaminants on those surfaces. If we had kids in the hearing 
room today, they wouldn't be sitting on chairs.
    U.S. Centers for Disease Control and Prevention researchers 
have found measurable levels of over 200 common industrial 
chemicals in body tissues and fluids of children of all ages, 
including cord blood. A number of hazardous chemicals also 
appear in breast milk. A substantial proportion, as Mr. Tonko 
mentioned, of chemicals known to have adverse, and mostly 
irreversible, effects on child health, such as lowering IQ, 
negative behavioral effects, and low birth weight, and reduced 
head circumference.
    The safety testing requirements under Section 4 of TSCA are 
inadequate to protect children's health, and place too great a 
burden for safety testing on the public sector. Chemicals 
introduced into commerce when the law was enacted are subjected 
to scant oversight. For new chemicals, the process basically 
doesn't work, and unless this legislation is reformed, with the 
tens of thousands of chemicals in need of review, and the 
multi-year process for each undertaking, it would require many 
decades just to review high production volume chemicals. These 
flaws limit EPA's ability to protect the most vulnerable, 
including children and pregnant women, because the agency faces 
substantial barriers to obtain the information needed to make 
effective risk management decisions.
    Under Section 8, TSCA has created a non-evidence based 
system for chemical management. Concerns about chemicals are 
permitted to be kept from the public. In their notifications to 
EPA, chemical companies may declare large amounts of 
information to be confidential business information. This broad 
exemption has effectively prevented the Environmental 
Protection Agency from sharing information about potential 
hazardous chemicals with community groups, local and State 
governments, and other organizations. Certainly an effective 
management system must include greater transparency than 
currently exists.
    Given the current urgent ongoing threat to children posed 
by chemical exposures, the American Academy of Pediatrics 
respectfully submits the following key recommendations for 
reforming the Toxic Substances Control Act. Under Section 4, 
manufacturers should be required to provide minimum data sets, 
with information that is relevant to the special needs of 
pregnant women and children regarding reproductive, 
developmental, neurodevelopmental toxicity, and endocrine 
disruption. Furthermore, EPA needs the flexibility to change 
data collection processes as new methodologies for testing 
become available.
    Under Section 4, the EPA should have a simple process to 
require additional testing when information suggests the need, 
especially for chemicals associated with child populations. The 
CDC's bio-monitoring program must be expanded to serve as an 
early warning system for exposures. Aggregate and cumulative 
exposure concepts similar to those in the Food Quality 
Protection Act should be considered by EPA. Companies must 
develop public information documents for each new chemical 
marketed that utilizes lay language, and is updated regularly.
    In conclusion, strong chemical management policy must 
integrate evidence-based decision-making for chemical use to 
adequately protect children, and other vulnerable populations 
from harm. The American Academy of Pediatrics looks forward to 
working with you to advance sound and protective chemical 
management policy during the 113th Congress. And I will be 
happy to entertain questions.
    [The prepared statement of Mr. Paulson follows:]


[GRAPHIC(S) NOT AVAILABLE IN TIFF FORMAT]


    Mr. Shimkus. Thank you very much. Now I would like to 
recognize myself for 5 minutes for the first round of, maybe 
the only round of, opening questions.
    So my first one goes to Mr. Drevna. Section 8 contains 
regulatory exemptions, as currently written. Some of these are 
for polymers and naturally occurring substances. Would you have 
concerns if a TSCA reform would invalidate those practices?
    Mr. Drevna. Well, Mr. Chairman, I believe that Section 8 
needs some reform, but I think there is a major misconception 
about, you know, what is out there, the 80,000 or so that some 
people say of chemicals that are out there, and really the 
10,000 or so that are in commerce. So I think what Congress 
should do is direct the EPA to say, OK, this is what is out 
there, and what is out there has to be, as many of the 
witnesses have said, has to, you know, any regulation has to be 
tiered, targeted, and risk-based.
    I believe, from hearing most of the witnesses here, if not 
all, but I think we all agree on it. I think it is what the 
definition of that is, and what the ultimate goal of the 
modernization of TSCA should be. So I think if we can agree on 
what is out there, allow EPA to do a tiered, targeted, risk-
based approach, we can all get to the end goal here.
    Mr. Shimkus. Thank you. Now, you know, we are not 
adversarial, so what I would like to do is try to get answers 
quickly. And it is a big panel, so this is for everyone on the 
panel, but for everyone to get through, please be as concise as 
possible. Does it make sense to have information quality 
standards for EPA to make decisions about chemicals? Mr. 
Drevna?
    Mr. Drevna. It makes sense for EPA to have the authority to 
find out what is out there, and, again, do the tiered, 
targeted, risk-based approach, and have the authority to do the 
testing----
    Mr. Shimkus. Quickly.
    Mr. Drevna [continuing]. Get rid of Section 4, the risk 
assessment first. We agree to that.
    Mr. Shimkus. Mr. Matthews?
    Mr. Matthews. It is always hard to argue with the notion 
that we should have quality standards in what EPA does. So, 
yes, we support EPA using the best available science and modern 
techniques.
    Mr. Shimkus. Mr. Grazman?
    Mr. Grazman. Yes, sir, we agree with you too.
    Mr. Shimkus. Thank you. Dr. Bosley?
    Ms. Bosley. Yes, absolutely. Information quality is of 
utmost importance.
    Mr. Shimkus. Dr. Willett?
    Ms. Willett. Yes, and EPA and other regulatory agencies 
have some of these, but they might be improved.
    Mr. Shimkus. Dr. Sass?
    Ms. Sass. My concern about having them hardwired into the 
system, while I think everybody agrees in principle, I think 
the process that the agencies are taking now to develop those 
in a public and transparent way, with public comment, is the 
approach that should be taken.
    Mr. Shimkus. Dr. Paulson?
    Mr. Paulson. Quality standards are important, but I don't 
think they should be in the legislation. The EPA needs the 
flexibility to change with time. And, as new technologies for 
chemical testing come on the market, they need to be able to 
respond to that.
    Mr. Shimkus. And my next question follows along on that 
response. Should different standards apply to testing? Mr. 
Drevna?
    Mr. Drevna. Yes.
    Mr. Shimkus. Thank you. Mr. Matthews?
    Mr. Matthews. Yes.
    Mr. Shimkus. Grazman?
    Mr. Grazman. I have got to defer. We are manufacturers, 
not----
    Mr. Shimkus. Right. Very good. Dr. Bosley?
    Ms. Bosley. Sure, should be based on risk.
    Mr. Shimkus. Dr. Willett?
    Ms. Willett. I am not sure I understand the question, I am 
sorry.
    Mr. Shimkus. Chemicals and processes are not all the same, 
so the question is should there be different standards applied, 
or should there be different standards to the level of risk-
based chemical that might be out there?
    Ms. Willett. Yes, I believe that is true, but I think I may 
tend to agree that it might not be a legislative issue.
    Mr. Shimkus. Dr. Sass?
    Ms. Sass. I think your question is about whether we should 
treat chemicals differently depending not only on their hazard, 
but also on their exposure. And while I agree that there is 
some intelligence to that, the concern is that we have very 
little exposure information, so there is a practicality that is 
lacking.
    Mr. Shimkus. Thank you. Dr. Paulson?
    Mr. Paulson. Mr. Shimkus, here again I think the EPA needs 
to have some flexibility. For example, had we only used hazard 
information on the chemical that was spilled in West Virginia, 
which was an industrial chemical, never intended for human 
exposure, other than the workers, then that chemical would not 
be reviewed. But, in retrospect, we are obviously in a 
situation where we wish it had been. So the EPA needs some 
flexibility. And we know, with the current law, the legislation 
has boxed them in in such ways that they can't function. We 
should not repeat that.
    Mr. Shimkus. Thank you. I am going to take prerogative for 
a last question to Dr. Grazman. You raised in your opening 
statement this issue about how current TSCA law inhibits the 
ability to recycle. Many of us are very concerned about 
recycling. Mr. Green's concerned about electronic recycling. 
Recycling is a good thing, not a bad thing. How does current 
TSCA law hurt recycling aspects?
    Mr. Grazman. So if I took the byproducts from----
    Mr. Shimkus. Pull the mike close.
    Mr. Grazman. If we chose to just landfill, or get rid of 
the byproducts from our process, there is no TSCA obligation at 
all. When we choose to recycle, the TSCA obligations hit us in 
their full weight. So, all things being equal, sometimes it is 
easier not to recycle.
    Mr. Shimkus. Thank you. We had that issue on ink and oil a 
couple Congresses ago, and the EPA kind of addressed it 
partially, but not fully, so that is an issue that we have 
raised in this committee before.
    Thank you very much. Now I turn to the ranking member, Mr. 
Tonko, for 5 minutes.
    Mr. Tonko. Thank you, Mr. Chair. This subcommittee has 
heard at previous hearings that EPA's ability to require 
testing of new and existing chemicals under TSCA has been 
dangerously limited. TSCA requires any company planning to 
manufacture or import a new chemical substance to submit what 
is called a pre-manufacture notice. It is supposed to include 
information such as the chemical identity, use, anticipated 
production volume, exposure and release information, existing 
available test data. According to EPA, 85 percent of the pre-
manufacture notices that agencies receive are accompanied by no 
toxicity data whatsoever.
    Dr. Sass, what kind of concerns does this raise for you?
    Ms. Sass. Well, not having any information at all means 
that EPA doesn't know how to move forward. It means that EPA 
has very little power or ability to request that information. 
There are restraints and constraints put on EPA in order to 
move forward and collect that information. And I think it 
burdens the agency unnecessarily. I think the burden should be 
placed on the industry to provide the information that EPA 
needs to do risk assessment, but previous to that, do a proper 
hazard assessment.
    Mr. Tonko. Thank you. For existing chemicals, Section 4 of 
TSCA requires EPA to show that a chemical poses an unreasonable 
risk before requiring additional testing. Dr. Paulson, how has 
this requirement helped to undermine the law?
    Mr. Paulson. This requirement basically has created the 
non-evidence based system that I referred to, and industry is 
basically penalized if they develop information in advance, 
because then they are required to report it to EPA, and that 
may adversely affect their bottom line. But with no reporting 
requirement, and then no ability to request information because 
you don't know there might be a problem, EPA is totally 
stymied.
    Mr. Tonko. Thank you. With any reform, we must make sure 
EPA has adequate authority to require testing to protect human 
health and the environment. In the Senate there is a proposal 
to require EPA to categorize each chemical as either high 
priority or low priority. Under that proposal, EPA would be 
blocked from requiring testing on low priority substances.
    My question, Dr. Sass, would that proposal increase testing 
of the chemicals we are exposed to every day, or would it make 
the problem worse?
    Ms. Sass. I think it would make the problem worse. It would 
hamstring EPA. It adds an additional catch-22 to EPA, because 
it needs information to do an informed prioritization, and 
without that information, it may miss many chemicals that are 
very hazardous, and may be very important not only for hazard, 
but also for exposure. It would miss that information, and then 
it would not be allowed to go back and have the authority to 
review the low priority chemicals, and, furthermore, at the 
State level they may also be hampered. So those chemicals may 
actually slip through what is not just a hole in the net, but 
really the whole net just doesn't exist because of those 
chemicals being able to fall through.
    Mr. Tonko. OK. And, Dr. Paulson, what does the Academy of 
Pediatrics think about blocking EPA from requiring testing on 
these so-called low priority chemicals?
    Mr. Paulson. Mr. Tonko, there does need to be a 
prioritization system for sure, but the EPA needs flexibility 
to move chemicals around, and any a priori blocking of chemical 
evaluation would imply that we would never learn anything. So 
if some miracle occurred, and new information came, the EPA 
couldn't use that new information, so that just really makes no 
sense. We have waited 40 years to modify this law. We should 
not create more barriers with a new law that will take another 
40 years to improve.
    Mr. Tonko. Thank you. The recent West Virginia chemical 
spill has brought this debate to life in many ways. The 
chemical that spilled into the Elk River, spelled MCHM, was 
shrouded in mystery. State and Federal officials had to 
scramble to uncover the few health and safety tests that had 
been conducted on that chemical. Dr. Sass, how did the lack of 
health and safety data on MCHM hinder the CDC, and other 
officials, when responding to that chemical spill?
    Ms. Sass. The data for those chemicals didn't come out for 
some time, and that created a concern, not only for public 
health officials at the State and local level, to be able to 
advise the community, and advise businesses about what to do, 
but also for the population as a whole, for citizens. The CDC 
was held back because it wasn't able to do the kinds of 
calculations and evaluations that it needs to provide informed 
and timely advice to the community. And, also, health officials 
and first responders weren't able to get information rapidly. 
They were having to advise and treat under a situation where 
they were essentially blindfolded because of that situation.
    Mr. Tonko. Thank you. I see my time is exhausted, so I 
yield back.
    Mr. Shimkus. The gentleman yields back his time.
    The Chair now recognizes the chairman emeritus, Mr. Barton, 
from the great Republic of Texas, for 5 minutes.
    Mr. Barton. If only we were still a republic. You know, 
that is water under the bridge. Well, thank you, Mr. Chairman, 
and Ranking Member, for holding this hearing. I don't have too 
many questions. My first question would be to Mr. Drevna, and 
you might not know the answer. Do you know how many chemicals 
right now are in the TSCA inventory?
    Mr. Drevna. I am sorry, sir, I didn't hear you.
    Mr. Barton. Do you know how many chemicals right now are in 
the TSCA inventory? We talking hundreds of thousands, millions?
    Mr. Drevna. Eighty to 100,000, I would imagine, if not 
more.
    Mr. Barton. OK. Anybody dispute that? Do you know how many 
new ones are listed each year, approximately?
    Mr. Drevna. I don't know, 700,000? Not 700,000, 700 to 
1,000, something like that.
    Mr. Barton. OK. I know this whole hearing is on testing and 
disclosure, and then we have the issue of the animal testing, 
but other than that, is there any major controversy on how 
these new chemicals are tested?
    Mr. Drevna. I believe that the testing for new chemicals is 
pretty well established. Much as I criticize the EPA, they have 
done a nice job, in my understanding, doing the new----
    Mr. Barton. OK, let us go to the young lady. What is your 
dispute with what Mr. Drevna just said about the----
    Ms. Sass. There is very little testing done on new 
chemicals, so EPA has issued some test rules, but it has been 
on a very few number of chemicals. EPA is restrained in a 
number of ways from issuing those test rules. There is timing 
on those. There are authority limitations for EPA. There is the 
requirement that it needs to actually find some hazard before 
it can issue new test rules, that catch-22 that several 
witnesses, including myself, mentioned. So, actually, it has 
been very ineffective. There has been very few chemicals that 
have been tested.
    Mr. Barton. Now, is your complaint that the EPA has tended 
to engage in what we call a voluntary procedure, as opposed to 
the more complicated mandatory procedure? Is that a complaint, 
or----
    Ms. Sass. Well, it is a complaint in where it hasn't 
worked. So there have been a number of voluntary initiatives 
that have been larger, and there has been some information that 
has been gathered from those, but not very much. So I would say 
that they haven't been effective overall, and there have been 
Congressional reviews that have shown that.
    But at the chemical by chemical level, so as chemicals are 
coming through the program, mostly, instead of EPA issuing test 
rules, because they are very cumbersome, and because they can 
be challenged, the EPA tends to negotiate with the company 
about what test rules it will issue. I am not opposed to that, 
so I am not complaining about that process, except where it has 
held back on EPA from being able to issue the kind of test 
rules that it needs to make a proper hazard evaluation.
    Mr. Barton. Dr. Paulson, you raised your hand.
    Mr. Paulson. I think that the voluntary programs have been 
ineffective. They have produced very little in the way of new 
information. The current legislation, and the judicial 
interpretation of that legislation, effectively block the EPA's 
ability to ask companies for toxicologic information on the 
chemicals that they are introducing into the market. And that 
results in playing catch up, where years later individual 
scientists at universities do studies, and, lo and behold, we 
find chemicals in human bodies that were never intended to be 
in human bodies, and we find that those chemicals have adverse 
effects on those human bodies. There are just numerous examples 
of that.
    Mr. Barton. Give me one example.
    Mr. Paulson. Brominated flame retardants, perflorinated 
chemicals, of which Teflon is one brand name. Those are two 
examples.
    Mr. Barton. And those chemicals were improperly tested, or 
improperly used, or illegally used?
    Mr. Paulson. None of the above, sir. They weren't 
adequately tested before they were marketed. They were used in 
ways that, presumably, industry thought was safe because they 
themselves did not have the data to indicate that they were 
getting into human bodies until later. And they didn't have the 
data that they were harming human bodies until later. So I am 
not suggesting any malfeasance here, it is just that, unless we 
develop the data before the chemicals come on the market, we 
are always subject to playing catch up.
    Mr. Barton. My time did expire, and I want to thank the 
panel.
    Mr. Shimkus. I want to thank my colleague. I just want to 
just follow up real quick on one of the answers. It is my 
understanding the burden of proof is in Section 4, not Section 
5, so we have got to be careful that we are conflating the 
authority under this law. That is why, going through this 
legislative process and our hearing is going to be very 
difficult, because we found that this language is very tough. 
So, with that, I would like to yield to my colleague, Mr. Green 
from Texas, for 5 minutes.
    Mr. Green. Thank you, Mr. Chairman, and I appreciate your 
interest in e-waste, and hopefully we can have a legislative 
hearing sometime so we can----
    Mr. Shimkus. I am sorry, I am not hearing you.
    Mr. Green. I am sorry. I can't imagine how hard it was in 
1976 for Congress to do TSCA, and that is probably why, for the 
last 38 years, it hasn't been revisited, because of the 
complexity of it. My first question is, before a company 
introduces something into a product, should there be some 
minimum level of due diligence? Because, Dr. Paulson, you 
talked about, the companies don't know. Should there be some 
type of due diligence by that company, just to make sure that, 
both for the folks producing that product, but also for the 
consumers, that they should have that due diligence on the 
toxicity of that product?
    Mr. Paulson. Yes, sir, that should be the basic function of 
any chemicals management policy, and we don't have that now.
    Mr. Green. OK. We heard testimony today about how difficult 
it is for EPA to make the required findings to require the 
generation of additional information on chemicals under 
existing provision Section 4. What additional authority should 
EPA have to mandate the testing? Like you said, maybe we ought 
to say there is a requirement by a company to do some basic due 
diligence, and then EPA should have the authority to ask for 
that information?
    Mr. Paulson. Companies should be required to release 
information to EPA. EPA should not have to ask for it. It 
should be part of the process before a chemical goes on the 
market that information goes to EPA. EPA is then able to 
evaluate that information, and make a decision. We also have to 
recognize that, even under the best of all possible 
circumstances, chemicals will receive approval that later turn 
out to be problematic, so EPA needs a mechanism to require 
companies to do post-market surveillance, provide the 
information on post-market surveillance----
    Mr. Green. I understand that, and I have heard that, you 
know, in any given day or week, at least in the last 38 years, 
how many different chemical substances have been entered into 
the market? Now, somewhere along the way, you know, if we have 
literally thousands of companies, and for them to give that 
information to EPA, and then to empower EPA to then go forward, 
I agree that, you know, EPA should have the authority to 
request that information and those testing levels. But I am 
just wondering, you know, how big EPA would have to be to be 
able to deal with the complexities of the market now. And I 
know, from our manufacturers and our specialty companies, it 
has got to be huge numbers of chemicals that are developed 
literally almost every day. Can you all just give us an idea on 
that?
    Ms. Bosley. Well, EPA looks at 20 chemicals a week, 20 new 
chemicals a week. That is their statistics. And beyond that, 
industry develops other chemicals that don't go forward, 
certainly. But the resources EPA needs to look at new chemicals 
are very different than what they have been given to look at 
existing chemicals. They have no mandate, really, to look at 
existing chemicals, and, therefore, that is not where the 
resources are spent.
    Mr. Green. Well, and that is part of our concern. I want to 
make sure, you know, our lifestyle has been built over the use 
of these chemicals. And granted there are times, for example, 
in West Virginia that nobody knew about that chemical. Even the 
first responders didn't know how to deal with it. So we need to 
deal with those, and that's the job of our subcommittee, to 
come up with something that will do that. Drevna?
    Mr. Drevna. Mr. Green, you are right. The thing about 
Section 4, which we agree, to an extent, that the finding 
requirement should be eliminated, but the hazard requirement 
should stay. So, I mean, you could, in essence, limit the 
number of chemicals that have to be looked at if you grant EPA 
the authority for testing, but they have to still have a 
component of that that says, wait a minute, there is a need out 
there for an exposure and a hazard requirement. So that would 
go a long way to remedying the situation.
    And, I mean, there have been criticisms of TSCA because it 
inhibits the EPA from collecting information, but there are 
other statutes that come into play too. Administrative 
Procedures Act, things like that. So look at it holistically 
also. And, you are right, though, Mr. Green, we have got so 
many, you know, large volume chemicals that they are 
intermediates, that never really see the market.
    Mr. Green. And, Chairman, I know I am almost out of time, 
but also the low priority and high priority, obviously 
something that is exposed vulnerable populations, should be a 
higher priority even, you know, and so there is a way, I think 
we can draft this, but it is not going to be easy, any more 
than it was in 1976. So thank you, Mr. Chairman.
    Mr. Shimkus. The gentleman's time has expired. The Chair 
now recognizes the gentleman from Pennsylvania, Mr. Murphy, for 
5 minutes.
    Mr. Murphy. Thank you. I appreciate this panel. We are 
learning a lot from all of you here. Mr. Drevna and Mr. 
Matthews, I think, Dr. Grazman, you may have talked about this 
too, about this whole prioritization process, how it works. And 
I believe, Mr. Drevna, in your testimony you wrote that there 
was not 80,000 chemicals, am I correct that was in yours, and 
there are really only about 10,000? How do we prioritize the 
safety of these in making some determinations? How do we set 
these rules up? All of our concern is that which is not 
forbidden is permitted, or that which is permitted is not 
forbidden, and we want to make sure we do this right. How would 
you recommend wording of this work?
    Mr. Drevna. Well, I will go back to what I said earlier, 
Congressman Murphy, tiered, targeted, and risk-based. If you 
give EPA the authority through statute to use that kind of 
mentality when addressing whatever chemical it is, whether it 
is a high volume chemical, or whether it is something that is, 
you know, a daily household product, if you do it tiered, 
targeted, and risk-based, and understand what, you know, what 
the hazards are, what the toxicity is, what the exposure is, 
and that will go a long way to giving EPA the right tools to 
address the situation.
    Mr. Murphy. OK. Mr. Matthews, do you have anything to add?
    Mr. Matthews. Well, I appreciate the doctor.
    Mr. Murphy. We didn't want to write ``doctor.''
    Mr. Matthews. Well, we agree, but let us be clear, the 
impression shouldn't be formed that there isn't substantial 
information on a lot of these chemicals that are in commerce, 
including existing chemicals, not just new chemicals. EPA has 
substantial information. It allows it to start to make some 
judgments about which are the chemicals that should be first 
put through a screening process, part of prioritization. What 
we have said is, they have substantial information, but they 
are missing a key component, and that is the use and exposure 
related information. So we think that EPA can do a proper 
screening process, even of the tens of thousands of chemicals 
that are already out in the marketplace. They need to do that. 
Make no mistake, this can't be done overnight. The numbers we 
are talking about are substantial. But, in order to get to the 
right choices first, they need not only the information they 
have historically been receiving, but additional use and 
exposure information, and start the process of getting through 
these existing chemicals that have been on the market.
    Mr. Murphy. Thank you. And, Dr. Bosley, can you explain the 
importance of how you protect the chemical identity of 
information that is submitted to EPA's----
    Ms. Bosley. Certainly. So we in the chemical industry, 
first and foremost, not one of us wants our chemical to cause 
harm to human health or the environment. By the same token, we 
live in the market reality, and we are faced with competitors 
every day. For instance, my company, very, very small. My 
competitors all know who I am. If I were to submit something to 
EPA with the chemical identity revealed, they would know 
immediately what sort of research I was doing, and, because my 
markets are so limited, they would know exactly where that end 
market would be. So it is not that I want to hide any hazard 
information that I have. I don't. I want to send that all out, 
but I would like to keep my chemical ID confidential. As long 
as there is a robust generic name, such that the public, the 
NGOs, and the EPA can all see what the generic name, and what 
the hazard is.
    Mr. Murphy. Thank you. Dr. Sass, I believe you, if I am 
correct, are recommending we adopt some of the standards the 
Reach program has in Europe. Do you think that would be more 
effective for us to do that?
    Ms. Sass. That wasn't in my testimony. Is that your 
question?
    Mr. Murphy. Yes, that is my question. Do you think that 
would be----
    Ms. Sass. Do I think it would be more effective? Well, I do 
think it would be more effective to have harmonization, and the 
other speakers have also mentioned that. I mean, having a 
patchwork approach across continents, across countries, across 
States, isn't any good for anybody. And I do think that the 
approach we should use should be the highest bar to protect 
human health and the environment. I think that not only saves 
costs and liabilities for the produces, manufacturers, users, 
and retailers, but also insurers in the healthcare. So, I mean, 
the difference between having a cancer and treating it, and 
never having had the cancer in the first place is huge, not 
only on personal cost, but on economic cost. So I think 
everybody has an interest in preventing problems. I think 
everybody agrees to that. The difference is how we are going to 
address them, and at what stage we are going to address them.
    So I would support a system that would give the regulatory 
agencies the authorities not only to have early comprehensive 
and timely testing, but to make decisions on what they have. 
Some of the other speakers have mentioned, and I agree, that we 
have substantial data on a number of chemicals, and I think we 
can take action on those.
    Mr. Murphy. I know we are almost out of time, but, Dr. 
Bosley, I would like you to submit also your responses to that, 
in terms of how the Reach requirements would contribute, being 
a big trade barrier for the United States.
    I am going to also add this too. I was recently meeting 
with a company in my district, Halgon Carbon. This little 
bottle of granulated activated carbon is what is used in many 
cases to clean up some of these chemical aspects. One gram of 
this, and there are about five grams in a pack of sugar, has 
more surface area than a football field. And I would hope that, 
as we are looking at these TSCA issues too, that we include in 
the whole package of analysis here not only what are the toxic 
levels in some of these chemicals, but also the cleanup process 
that would mitigate these things is a critically important 
part, by which we take a chemical of concern to a chemical of 
safety.
    And with that I yield back, Mr. Chairman.
    Mr. Shimkus. The gentleman yields back the time. The Chair 
now recognizes the ranking member of the full committee, Mr. 
Waxman, for 5 minutes.
    Mr. Waxman. Thank you, Mr. Chairman. A number of today's 
witnesses have testified in support of a risk-based approach to 
chemical regulation, and I would like to explore this topic.
    Dr. Sass, I would like to see if you could help us 
understand what a risk-based approach means. To understand the 
risk a chemical poses, EPA would have to need information on 
both the hazard the chemical presents, as well as information 
about exposure. Can you tell us what information EPA would need 
to implement a risk-based system that the American people can 
have faith in?
    Ms. Sass. Well, sure. So EPA already does conduct risk 
assessments on chemicals, and that means that it has both how 
bad the chemical is, the hazard information, and what are the 
chances, or probabilities, that you are going to be exposed to 
it, the exposure information, and that is important. But, 
earlier than that, EPA has to be able to collect both those 
sets of information, and what this is trying to get at is 
hazard. It is important to separate those out, because later, 
when you make risk management decisions, they will take into 
account exposure as well.
    But, at this stage, doing a hazard assessment, it is 
critical to focus on the hazard only. There are a number of 
reasons why. For one thing, we have more of that data than we 
do about exposure information. Exposure information is very, 
very expensive, and difficult to get. I wish that the chemical 
industry could give us the kind of exposure information that 
they have all testified that EPA should have. But it is----
    Mr. Waxman. Well, without this information, we wouldn't be 
able to understand the risk a chemical presents, is that what 
you are saying?
    Ms. Sass. That is right. Half the equation would be gone. 
We don't have that information.
    Mr. Waxman. Dr. Paulson, do you agree?
    Mr. Paulson. Yes, Mr. Waxman.
    Mr. Waxman. I would like to turn to Mr. Drevna. In your 
testimony, you suggested EPA should first make screening 
decisions. That is, EPA should determine whether a chemical 
should be a high priority or a low priority based on existing 
information about what you describe as ``potential hazards and 
exposures''. Are you recommending that EPA make decisions 
without having actual information about hazards and exposures?
    Mr. Drevna. No, sir, not at all. We are recommending----
    Mr. Waxman. Is your mike on there?
    Mr. Drevna. Yes, it was.
    Mr. Waxman. OK.
    Mr. Drevna. No, sir, not at all. We are recommending that, 
you know, you can adopt a system, like the Canadians have 
adopted, where you can have, you know, you rank chemicals, you 
understand the molecular structure to most of them, you know, 
and you can use current technologies to figure out, you know, 
rank them, do the exposures. We are recommending that EPA have 
the authority to ask for exposures under a new Section 8(a), 
you see in my testimony. Absolutely, no, we are recommending 
that----
    Mr. Waxman. I appreciate that. So under the Senate 
proposal, the screening level decision would be a very 
important one, because once a chemical is designated as a low 
priority, the chemical is shielded from further study and 
review. Dr. Sass and Dr. Paulson, is there sufficient existing 
information in most cases for EPA to determine that chemicals 
are low priority, and shouldn't be subject to any further 
scrutiny?
    Ms. Sass. No, that concerns me. Determining something is a 
low priority, or not hazard, should be a very high bar. For 
example, the International Agency for Research on Cancer under 
the World Health Organization has, I think, only one or two 
chemicals in that category. It should be a very high bar to 
actually put something aside and not look at it anymore from a 
public health and environmental protection perspective.
    Mr. Waxman. Is there sufficient information?
    Ms. Sass. Without sufficient information.
    Mr. Waxman. Dr. Paulson?
    Mr. Paulson. No, sir. I think, particularly for new 
chemicals, by definition, there is not sufficient exposure 
information.
    Mr. Waxman. Um-hum.
    Mr. Paulson. And even for chemicals that have been around 
for a number of years, there may not be bio-monitoring 
methodologies that are available. There may not be 
methodologies for measuring those chemicals in soil, or other 
organisms besides humans. So, as Dr. Sass mentioned, exposure 
information is often extremely limited.
    Mr. Waxman. OK. Well, in Mr. Grazman's testimony, he 
objects to EPA collecting certain information. For example, he 
objects to the collection of information about worker exposure. 
He also seems to object to reporting about the volume of each 
chemical that is manufactured, and the consumer and commercial 
uses of chemicals. Dr. Sass, this seems like important 
information for understanding exposure. Can EPA evaluate 
exposure, and therefore risk, if it doesn't have information on 
how chemicals are used, and how exposure might occur?
    Ms. Sass. You know, Mr. Waxman, you are exactly right. EPA 
needs much more use and production, and also downstream use 
information, and it needs to be able to update that information 
in a timely manner as that chemical travels through commerce, 
and has different----
    Mr. Waxman. If we want EPA to make good decisions, then 
that means we don't want them guessing. That means you can't 
have both a risk-based system, and an unwillingness to provide 
EPA with adequate information, is that your----
    Ms. Sass. That is correct. I agree.
    Mr. Waxman. And Dr. Paulson, would you care to comment on 
this issue from a children's health perspective?
    Mr. Paulson. While adult workers obviously aren't children, 
they are often sentinels, and we need to be able to gather 
information on worker exposure and use that information to help 
understand, perhaps, either gaps that we need to fill about 
children, or be able to extrapolate to children in the 
instances where you can. So just in that one narrow area that 
you are talking about, I certainly agree that blocking the 
EPA's ability to collect and use that data will make it much 
more difficult to make decisions about chemicals.
    Mr. Waxman. And thank you, Mr. Chairman.
    Mr. Shimkus. The gentleman's time has expired. The Chair 
now recognizes the gentleman from Ohio, Mr. Latta, for 5 
minutes.
    Mr. Latta. Mr. Drevna, if I can again start with you, how 
do you believe the coordination between the EPA and the TSCA 
interagency testing committee has been?
    Mr. Drevna. That is a good question. I mean, I really don't 
know what they have done. I don't.
    Mr. Latta. Have you heard anybody else talking about it? No 
one? OK. Well, maybe we ought to check into that. Mr. Matthews, 
if I could ask you currently, TSCA includes processes within 
the scope of Section 8, and in your testimony you discuss how a 
revised TSCA should expressly allow the EPA to collect 
necessary use information from downstream processors. How does 
this improve upon the existing construct? And then, just as a 
follow-up, then, do all processors support the view? Do all 
processors support this view?
    Mr. Matthews. Well, OK, I mean, I am here to speak on 
behalf of CSPA. I was at pains to say we are a segment of that 
industry. One of the problems the EPA has is they have had 
difficulty defining who a processor is. We circulated a 190 
page document they created that attempted to define processor, 
but in the end, it couldn't, so it is a very broad category.
    And, coming back to your first question, one of the 
problems, I think, is that EPA literally fears sending out an 
information request or demand from ``processors'' because it 
will produce more information than they can conceivably manage. 
What we have proposed is a more targeted and focused 
information flow of use and exposure information from that 
segment of the processor community that we represent, which is 
household and institutional products, which, during that 
screening phase, during the prioritization phase, will actually 
align with the kinds of issues that EPA is considering. And I 
would go back to the questions that have been asked about 
hazard, you still need hazard information, and there is 
substantial information on hazard that has already been 
generated, and EPA has its authorities in that regard.
    But you would combine that with the kind of information 
about exposures that EPA is concerned about, as it says, how do 
we work through tens of thousands of chemicals in a logical 
way? Which should be our priorities? And on that basis, the 
kind of information that we would provide I think would go a 
long way to answering those questions.
    Mr. Latta. Thank you. Dr. Grazman, what is the EPA doing 
with all this duplicative byproduct data that they are 
collecting?
    Mr. Grazman. That is a good question, sir, and I don't know 
the answer. We have seen no evidence that they are doing 
anything. And part of this, and it actually goes back to the 
kind of--Mr. Waxman made quote in my written testimony, as I 
mentioned, we are a manufacturer. We make our products through 
a series of chemical and physical steps. None of the chemical 
steps is perfectly balanced. Each one produces a byproduct.
    And so right now, when I say we find it very difficult to 
report to EPA the amount and nature of each byproduct, it is 
because I have got 30 chemical processes that might use five 
different chemicals that we buy, and then I have to understand 
the amount of each component that is left over, how they may 
react, and how any recyclers I send it to may process it. So if 
you imagine that EPA is not only trying to handle the data from 
chemical manufacturers, but from people like us, it truly would 
be overwhelming.
    Mr. Latta. Let me follow up. Even if these byproduct 
manufacture were to be exempted from reporting, companies 
manufacturing new chemicals from recycled byproducts would 
still be required to report on the manufactures they are 
manufacturing. Is that what would be happening, then, that they 
would----
    Mr. Grazman. Yes, sir.
    Mr. Latta. Yes.
    Mr. Grazman. The processors of our byproducts are reporting 
on what they make out of them.
    Mr. Latta. OK. Mr. Drevna, if I could go back to you, I was 
kind of interested in what you were saying about Canada, and 
about the model that they use up there. How would you rate the 
model that they use in Canada?
    Mr. Drevna. Congressman, I think it is one that Congress 
should help EPA adopt. I think it is a good program. As one of 
the witnesses says, it would help, you know, categorize. It 
would help eliminate, and it is working for our friends to the 
north.
    Mr. Latta. And I know that Mr. Murphy had asked a question 
a little bit earlier about this, or kind of touched on it, also 
in your testimony I found it interesting that many people are 
of the false impression that there are 80,000 chemicals in 
commerce, and you say it is something less than 10,000. Where 
did it ever come up that people thought there were 80,000?
    Mr. Drevna. Well, I think once a chemical is out there on 
the list, it never gets off, and there are so many 
intermediates. It is a, you know, it is like the Hotel 
California, you can come in, but you can't check out.
    Mr. Latta. OK. On that Eagles note, I will yield back.
    Mr. Shimkus. Showing your age. So thank you. Now the Chair 
recognizes the gentlelady from the Denver Broncos, I mean from 
the great State of Colorado, Ms. DeGette, for 5 minutes.
    Ms. DeGette. Thank you so much, Mr. Chairman. And, in an 
attempt to be bipartisan, I will say we are working together 
very well on this TSCA reauthorization, and I am pleased that 
we are having this hearing. There is a group of us on this side 
of the aisle who really do want to work in developing this 
legislation, as we discussed last night, and I am hoping we can 
do it as it goes along.
    I think there is consensus that some of the biggest 
problems we have with the implementation of TSCA are rooted in 
the procedure requirements under Section 4 for testing existing 
chemicals, and so I want to focus on that during the first part 
of my questioning.
    Dr. Bosley, I wanted to ask you, yes or no, should the EPA 
have to go through a rulemaking every time it needs data on an 
existing chemical?
    Ms. Bosley. No, absolutely not.
    Ms. DeGette. And, Dr. Sass, what is your view on that?
    Ms. Sass. No, it should not, I agree.
    Ms. DeGette. OK. So it seems to me, I think everybody 
pretty much agrees on this, one of the easiest ways to improve 
TSCA would be to allow the EPA to request testing by order than 
rulemaking, especially for existing chemicals where the data 
probably already exists. Everybody is nodding, so, Mr. 
Matthews, I am going to pick on you for a second.
    I know you have got extensive experience providing counsel 
to chemical companies, and I am assuming that chemical 
companies, legitimate ones, like your clients, perform basic 
testing of the products they sell in order to determine they 
are safe. Is that right?
    Mr. Matthews. Well, mind you, we are the downstream 
purchasers of----
    Ms. DeGette. OK.
    Mr. Matthews [continuing]. Raw materials from upstream. It 
is upstream where that actual testing of the chemical itself 
takes place, but our companies go to great lengths to ensure 
that the chemicals they put into their products are safe, so 
they are----
    Ms. DeGette. Right.
    Mr. Matthews [continuing]. Looking at that data.
    Ms. DeGette. So both the manufacturers, but your clients 
too, they are not going to put those things on the market 
unless they are pretty sure they are safe?
    Mr. Matthews. That would be absolutely correct.
    Ms. DeGette. And so both the downstream and upstream folks 
are going to have information on file about the effects of the 
products, right?
    Mr. Matthews. I mean, I think often the manufacturers say 
it is not readily ascertainable to us as to how it is being 
used, and what kind of exposures are being created. So they 
have some, but not enough, for EPA's purposes. That is where we 
come in.
    Ms. DeGette. OK. So what you said in your written testimony 
is exactly that, very little information is readily available 
to the agency on how chemicals are used in U.S. commerce in 
order to fully inform prioritization, and to assess the human 
health and environmental risk. That is exactly the point. So I 
guess I would like it if you could just spend a second talking 
to me about what you think about the current process of 
rulemaking, and what could be done to help the EPA access this 
information better. Would your clients agree with a different 
system, and what would it be?
    Mr. Matthews. Indeed we would. We would propose that there 
actually be statutory changes that would address a more direct 
and meaningful role of the downstream community that has----
    Ms. DeGette. I mean, we are drafting the bill, so what 
kinds of changes would you support?
    Mr. Matthews. We would support a statute directing EPA when 
it goes through this screening process, I mean, we are trying 
to thread the needle here. They have to----
    Ms. DeGette. Right.
    Mr. Matthews [continuing]. Screen to get the prioritization 
to get a list of substances that will go through a safety 
assessment process. So, as they conduct that initial screening, 
they have substantial information at their disposal. And we are 
talking----
    Ms. DeGette. So you would support them providing that 
information to the EPA?
    Mr. Matthews. I think the EPA generally has a lot of that 
information, but yes, any updated information should----
    Ms. DeGette. Without rulemaking?
    Mr. Matthews [continuing]. From the manufacturers.
    Ms. DeGette. Right.
    Mr. Matthews. And now we would propose adding to that 
provisions that would direct the agency to also, then, collect, 
for the substances under review, use and exposure information 
from the companies that have it.
    Ms. DeGette. Great. Thank you. Now, Dr. Paulson, I want to 
talk for a minute about the EPA authority, because, you know, 
they have got 83 existing chemicals right now, so that is good, 
but as the EPA studies those priority chemicals, science will 
evolve, and we might know more about those chemicals that are 
not on the priority list. So, Dr. Paulson, you support a 
simpler process for the EPA to gather data. Can you just talk 
briefly about how our understanding has evolved, and how 
chemicals affect infants, children, and other vulnerable 
populations?
    Mr. Paulson. Yes, ma'am, thank you. Children have periods 
of vulnerability from the time that really actually start 
before conception, if we can understand that, conceptualize 
that, and then, after conception, throughout pregnancy, and the 
brain finally finishes developing somewhere around 25 years of 
age, in terms of final myelination of coding of the nerve cells 
in the frontal part of the brain. Likewise, the lungs continue 
to develop until children reach whatever their adult height is, 
so this is a process that takes many, many years, and damage 
that is done before the process has finished, whether you are 
talking about the lungs, or the brain, or the kidney, often is 
irremediable. You don't get to start over or do-over in the 
human body.
    So data that is collected to make decisions on the safety 
of chemicals needs to acknowledge these periods of 
vulnerability, test around issues that pertain to these periods 
of vulnerability, and then use that information in decision-
making.
    Ms. DeGette. Thank you, Mr. Chairman.
    Mr. Shimkus. The gentlelady's time has expired. I do look 
forward to working with her, and if you check on 8(d), I am not 
going to read this part, but part of that is in current law 
too, and that is part of the problem of some of the things that 
you asked about.
    The Chair now recognizes the gentleman from West Virginia, 
Mr. McKinley, for 5 minutes.
    Mr. McKinley. Thank you, Mr. Chairman. Several of the 
panelists, and some of the Members of Congress, have mentioned 
and drawn attention back to the problem they had down in the 
2nd District in West Virginia, down in the southern part of the 
State. And I join with you in the disgust and the fury 
internally I have over the breakdown of why that could occur. 
So I am hoping that, from this hearing and elsewhere, we will 
learn more, and not do a knee-jerk reaction, but we will try to 
get this thing resolved. I know the Attorney General is looking 
into it, and a series of others are looking into that.
    But let me go back to Dr. Paulson, and some of your 
remarks. In your testimony you said that, under TSCA Section 8, 
companies are required to keep a file of allegations of 
significant adverse reactions to human health or the 
environment of any chemical they manufacture, and the companies 
must also provide this information to the EPA upon request. 
Now, I am just curious, given the MCHM issue of a discharge 
into the Elk River, do any of you know, was there a request 
that was denied about the MCHM?
    Mr. Paulson. I am sorry, can you state the last part of 
that question again? Just didn't quite hear you.
    Mr. McKinley. Did the EPA, did they seek information about 
this? Because that is what it says, companies must provide this 
information to the EPA upon request. Did the EPA request 
information about this chemical, one of two chemicals that was 
discharged into the Elk River?
    Mr. Paulson. In the post-leak time phase, I don't know, 
sir.
    Mr. McKinley. OK. Well, let us go just a little bit further 
with that. Is there something more that they can do? Because I 
heard a little bit ago you were saying, I think, in your 
testimony that these things deal with confidentiality. I am 
just wondering whether or not that was also an item that--was 
it held back because of--or, Dr. Sass, do you know whether or 
not either of these things has occurred?
    Ms. Sass. So I do not know the specifics of conversations 
that may have happened early in the spill between EPA and West 
Virginia, but I think what the speakers had talked about, if I 
am correct, referring to your question, is the idea that, if 
there is an accident, or a spill, or an incident like this, 
that it should be reported to EPA.
    And the model, I think, is FIFRA 6(a)(2), which is the 
pesticide model, so that if there is an incident, or a spill, 
or a poisoning, that a report has to be made to EPA under FIFRA 
6(a)(2), and that data is kept there, and that the obligation 
to make that is the registrant, the chemical manufacturer in 
this case. And that way EPA has a docket of these. And so 
later, when EPA is reviewing those pesticides, which it does 
every 15 years on a routine basis, and updates the science, it 
can look and see if there has been a problem with fish kills, 
with worker poisonings, child poisonings, things like that.
    Mr. McKinley. How we can strengthen it, how we can make 
this thing work better, because was this information even 
available? That is what I am trying to find out about the MCHM, 
was it out there?
    Mr. Paulson. We do know----
    Mr. McKinley. Because the first responders needed to know. 
There was the delay in reporting. We have got to find out how 
to make this thing better, and so I am looking under Section 8, 
how we might be able to modify that.
    Mr. Paulson. Well, we do know that the company, Eastman, 
did provide some additional information, and I don't know 
whether that was at the request of EPA, the agency for Toxic 
Substances and Disease Registry----
    Mr. McKinley. OK. So----
    Mr. Paulson [continuing]. The West Virginia Department of 
Health. So they did, in relatively short order, provide some 
additional information. Then the Federal agencies needed to 
analyze that, which, of course, takes time. I think that, had 
this information been provided to the government before the 
spill, there might have been a quicker turnaround.
    Mr. McKinley. Well, that is what I am trying to find out, 
is why it failed under Section 8, that they didn't provide that 
information prior to this. That is what I am trying to find out 
about.
    But let me just close in the few seconds we have left that 
I join with you in this concern about what happened down there, 
and the need to work on TSCA. I am with you on that, as one of 
just two engineers here in Congress. We need to work on this. 
But I wish I could have seen the same fury from you all about 
the situation in Bud, West Virginia. Bud, West Virginia, for 
those of you that aren't aware, they have been without water, 
this is their sixth month.
    And for a community, Dr. Willett, you are only concerned 
with the animal, where are they getting the water? Because it 
is untreated. And these people, for six months, have gone 
without water down in Wyoming County, West Virginia. Six 
months. And I haven't seen anything in the headlines about 
that. You know, people chasing that issue, take care of those 
families, the children looking for water in their fountains, 
and their school districts are closed. I know you don't have 
jurisdiction over that, but I would think many of the advocates 
out there in America would have raised this issue, that that is 
not an acceptable way for a community to exist. They have to 
rely for six months on bottled water.
    Afraid my time is over.
    Mr. Shimkus. The gentleman's time has expired.
    The Chair now recognizes the gentleman from California, Mr. 
McNerney.
    Mr. McNerney. Did the gentleman yield?
    Mr. Tonko. Mr. Chair, if I might, I think that that line of 
questioning from our colleague is important, because it 
highlights one of the failures of the existing law, in that it 
didn't require the company to notify the EPA of the substance, 
so vast improvements are required here.
    Mr. Shimkus. I thank my colleague. I would just remind my 
colleagues that there is Federal law called the Emergency 
Planning and Community Right to Know Act, under which they 
should have filed with the local first responders. The second 
thing, under Section 8(e), is peril authority, and so is 8(c), 
that this information should have been filed with the EPA. So, 
having that, I will turn to Mr. McNerney for 5 minutes.
    Mr. McNerney. I thank the Chairman. I just want to say, all 
the testimony I have heard this morning was very constructive, 
very positive, in terms of where we should be going, and I 
appreciate that.
    Dr. Paulson, in your testimony, you raised concern about 
chemical companies claiming that important health and safety 
data is confidential business information. Have CBI claims made 
it difficult for key stakeholders to gain information about 
potentially hazardous chemicals?
    Mr. Paulson. To the extent that we don't know what is 
included in the CBI claims, I can't answer that definitively, 
but certainly that is a big concern. I think there is 
information that should be available to the public that these 
companies know, and they are making claims of CBI that lock the 
public's right to know.
    Mr. McNerney. Well, today the committee received a letter 
from the Center for Environmental Health regarding today's 
hearings on Sections 4 and 8 of TSCA. Mr. Chairman, I request 
that this letter be made a part of the hearing.
    Mr. Shimkus. Without objection, so ordered. I think we have 
already seen it.
    Mr. McNerney. Thank you. According to the letter, the 
Center for Environmental Health, and I quote, ``is particularly 
concerned with whether or not the EPA has enough data to make 
appropriate designation for individual chemicals. Any revision 
of TSCA must ensure that the EPA has adequate data to 
demonstrate that the chemical truly has a reasonable certainty 
of no harm before the agency deems the chemical to be a low 
priority''. Then they go on to note that the law must require 
chemical companies to submit minimum information sets in a 
timely manner, equipping the EPA to evaluate new chemicals and 
new uses of chemicals, and to evaluate chemicals for 
prioritization.
    Mr. Paulson, what is your biggest concern about what the 
revision of TSCA might not do?
    Mr. Paulson. My biggest concern is that a revision to the 
Toxic Substances Control Act would not allow EPA to collect 
sufficient data to make decisions. And they can't make good 
decisions without good data. There need to be identified 
minimum data sets that will collect information that pertains 
to children and pregnant women, at least from my standpoint, as 
a pediatrician. They are not the only groups that need 
protection, but let me just talk as a pediatrician, and that, 
unless any new legislation gives them that authority, gives 
them the authority to request additional information when they 
feel that it is necessary, and gives them the authority to 
continue to receive information after a marketing decision has 
been made, then we will all be right back here, talking about 
problems with chemical management policy.
    Mr. McNerney. Thank you. Dr. Sass, do you have additional 
concerns about what the new legislation may not accomplish?
    Ms. Sass. I think that my biggest, is actually that it 
won't give EPA the authority to actually make a decision to 
take action, that it will hold EPA in a holding pattern 
forever, collecting information, and needing more information, 
and waiting for information, and that would be sad, because 
there are huge initiatives across all agencies to develop more 
rapid and less costly testing. And I think that Dr. Willett had 
mentioned some of these. We can start to do mixtures, we can do 
formulations, we can look at interactions, different life 
stages. There are some exciting new scientific data on the 
horizon, the near and the far horizon. Computational toxicology 
will be really exciting, and it would be a shame if EPA was 
hamstrung in an old dinosaur science framework.
    Mr. McNerney. Thanks. Mr. Drevna, what is your biggest 
concern about what the new legislation may do?
    Mr. Drevna. Two things, Congressman. One, we have to keep 
in mind that this is a health and an environment statute, and 
it is a commerce statute. And one of the things of a major 
concern to us is Federal pre-emption. We would urge Congress, 
in its revisit and rewrite of TSCA, to make sure that, you 
know, as I said, that we don't, you know, inhibit the 
manufacturing renaissance by having a patchwork quilt of kinds 
of various State regulations. I mean, this is a statute that 
calls for Federal pre-emption.
    Mr. McNerney. Anyone else on the panel wish to answer that 
question? What is your biggest concern about what the 
legislation may do? All right.
    With that I will yield back, Mr. Chairman.
    Mr. Shimkus. The gentleman yields back his time. The Chair 
now recognize the gentleman from Ohio, Mr. Johnson, for 5 
minutes.
    Mr. Johnson. Thank you, Mr. Chairman, and I too want to 
thank the panel for being with us today. Let me start with Dr. 
Willett and Dr. Bosley, if I could.
    How do you respond to the call for a minimum data set on 
all chemicals on the TSCA inventory, and why? Dr. Willett, you 
go first.
    Ms. Willett. I believe that our science and technology is 
at the point where we can redefine what minimum data set means.
    Mr. Johnson. OK. Dr. Bosley?
    Ms. Bosley. I think that the general industrial chemicals 
are not a one size fits all, and I think a minimum data set is 
the wrong approach. I think that the data sets that EPA needs 
should be based on the risk of the chemical.
    Mr. Johnson. OK. For both of you, a follow on, is every 
data gap a data need, in your opinion, and why?
    Ms. Willett. That is a tough question. No.
    Mr. Johnson. OK.
    Ms. Willett. I think EPA should be allowed to figure out 
which data gap is really a data need. They are, as I said, very 
talented scientists and engineers there, and they know what 
data they need.
    Mr. Johnson. OK. Dr. Willett, a follow on for you. You 
mentioned that a single two-generation reproductive toxicity 
study requires at least $380,000, 2 years, and 2,600 rats. Is 
this kind of test normal under a minimum data requirement?
    Ms. Willett. It depends on the chemical sector, but it is a 
common test that is required now.
    Mr. Johnson. So it would be considered normal? OK. Mr. 
Grazman, how are you today?
    Mr. Grazman. Good, thank you, sir.
    Mr. Johnson. How are things back in North Jackson?
    Mr. Grazman. North Jackson is doing well.
    Mr. Johnson. Good. Mr. Grazman, Section 9 of TSCA directs 
the EPA to coordinate TSCA actions with actions taken under 
other Federal laws to avoid unnecessary duplication. As a 
manufacturer, are you aware of any steps that EPA has taken to 
coordinate reporting requirements----
    Mr. Grazman. No, sir----
    Mr. Johnson [continuing]. Or processes?
    Mr. Grazman [continuing]. We are not aware of any.
    Mr. Johnson. You are not aware of any coordination----
    Mr. Grazman. We have----
    Mr. Johnson [continuing]. Done?
    Mr. Grazman. We report, and for understandably good 
reasons, to multiple divisions of government, and organs of 
government, that ask for the data.
    Mr. Johnson. OK.
    Mr. Grazman. Whether it is the first responders in our 
area, whether it is the environmental pluses of business, it is 
everybody from our insurers, and our own shareholders, and our 
own systems, so----
    Mr. Johnson. Same data?
    Mr. Grazman. Pardon?
    Mr. Johnson. Same data?
    Mr. Grazman. Yes.
    Mr. Johnson. OK. Can you describe for the subcommittee the 
environmental reporting that your company undertakes under 
other laws? Now, you just mentioned a few of them, and how that 
may overlap with reporting requirements under Section 8 of 
TSCA?
    Mr. Grazman. To do a complete job, I would really rather 
follow up with you later and----
    Mr. Johnson. OK.
    Mr. Grazman [continuing]. That information.
    Mr. Johnson. Yes, if you could get us that, that would be 
great.
    Mr. Grazman. Yes, sir, happy to.
    Mr. Johnson. What steps does your company take to ensure 
the responsible use, storage, and transfer of chemicals? What 
laws, for example, regulate these activities?
    Mr. Grazman. Every material that we bring in our factory is 
evaluated for its safety in terms of its storage, its handling 
to our workers, and its possible interactions with the other 
chemicals that we use. Everybody from our insurance company to 
the third party registrar of our environmental management 
system audits our facilities against both the chemical and the 
handling aspects of those things. We have customers doing 
audits, because when a Department of Defense program is buying 
their circuit boards from us, if our factory fails, potentially 
they fail. So they are in making sure that our processes are 
safe, and will provide a continued stream of products that they 
need.
    Mr. Johnson. OK.
    Mr. Grazman. And then we have actually instituted a program 
called layer process audits, where literally every day every 
part of the factory is being looked at against checklists for 
safety and efficiency.
    Mr. Johnson. Are there any regulatory gaps that we should 
worry about closing?
    Mr. Grazman. I think the aspect of the regulation that 
surprised us when we chose to start recycling, that we got hit 
as if we were manufacturing chemicals. I would like to see that 
closed, and I think that would also help EPA in reducing the 
data they need so that they can focus on those that are 
necessary for----
    Mr. Johnson. OK.
    Mr. Grazman [continuing]. Their effectiveness.
    Mr. Johnson. Well, thank you for that.
    Mr. Chairman, I yield back.
    Mr. Shimkus. The gentleman yields back his time. The Chair 
now recognizes my colleague from the State of Illinois, Ms. 
Schakowsky, for 5 minutes.
    Ms. Schakowsky. Thank you, Mr. Chairman, and to our panel. 
I really apologize, I was at another hearing and couldn't come 
and hear your testimony, but I do have a few questions.
    As written, Section 4 of TSCA makes it extremely difficult 
for the EPA to require testing of existing chemicals, but that 
doesn't mean, as has been discussed, the chemical companies 
never conduct any tests on these chemicals. They may conduct 
safety testing for a variety of reasons, apart from any 
requirement on TSCA. A company could conduct safety tests to 
comply with the State law, to meet European requirements, if 
you want to export, or a company may want to conduct testing to 
assess potential tort liabilities.
    So, Dr. Bosley, is that right, that companies may conduct 
safety tests on a chemical for a variety of reasons?
    Ms. Bosley. Yes. We conduct tests whether or not EPA asks 
for them in general.
    Ms. Schakowsky. And Mr. Matthews?
    Mr. Matthews. Yes--are not doing the actual toxicity 
testing, but they don't put a product on the market where they 
haven't reviewed the toxicity of each of the chemicals they put 
in those products.
    Ms. Schakowsky. But the EPA and other health officials 
often don't see these tests. As we have discussed also, Section 
8 only requires chemical companies to immediately submit to the 
EPA information they obtained that, quote, ``reasonably 
supports the conclusion'' that a chemical, quote, ``presents a 
substantial risk of injury to health or the environment''.
    So, Dr. Paulson, in your testimony, you say that TSCA has 
created a non-evidence based system for chemical management. 
Can you explain what you mean by this?
    Mr. Paulson. In medicine, in the latter part of the 20th 
century, in the early part of the 21st century now, we talk 
about practicing evidence based medicine, that the decisions 
that we make should be based on rigorously collected 
information to inform those decisions. So I have taken that 
term that is used in medicine and applied it to a different 
arena. And what I am suggesting here is that, in terms of new 
chemicals, the companies are, in essence, penalized if they do 
research, because they are required then to report that 
research to EPA, and EPA might then use that research to make a 
decision the company doesn't want made.
    And, in terms of the chemicals currently on the market, the 
quote that you just read, in terms of the definition of 
substantial, that makes it very easy for companies to decide 
that it is not substantial. And I think the standard should be 
that companies need to disclose information that they have.
    Ms. Schakowsky. Thank you. The recent chemical spill in 
West Virginia, which you have also talked about, illustrates 
the problems created when chemical testing data isn't widely 
shared and available. On January 11 the Centers for Disease 
Control told West Virginians that the water would be safe to 
drink at one part per million of the chemical of concern, MCHM. 
Four days later CDC said it obtained new animal studies leading 
it to recommend that pregnant women not drink the water at all. 
EPA told committee staff that the agency didn't have any 
studies on the chemical. A week after the chemical spill was 
discovered, Eastman, the chemical manufacturer, finally made 
public the summaries of several safety studies.
    Dr. Sass, how did this slow disclosure of the relevant 
safety studies affect your ability, as a scientist, to assess 
whether government was doing enough to protect public health?
    Ms. Sass. Well, in the first few days, the public was 
completely blindsided, and blinded, with no information. The 
LD-50, the lethal dose that kills 50 percent of test animals, 
which is very crude, and not the kind of test we want to use to 
set a drinking water standard for a population, was the only 
test that seemed to be available. I found it on an MSDS, or a 
material safety data sheet. That is what CDC used initially.
    Later they found a no effect test in rodents, a 28 day 
rodent test, which they used. That is more informative. The 
problem with that test is that only the conclusions of the 
study were provided to the public, so there was no way to 
analyze those data, or to re-analyze the data, or to confirm it 
was a, you know, trust us, we are the experts type of study 
from the industry, and that is wholly inappropriate for public 
health agencies, first responders, scientists, and the public 
to get any confirmation. So I think that it violated the public 
trust, and it put public interest groups in a blinded position, 
and it hamstrung the Federal agencies considerably.
    Ms. Schakowsky. Let me just say that I think that it really 
affected the confidence of the West Virginians, both in the 
safety of their water, and in the government's ability to 
respond.
    Thank you, I yield back.
    Mr. Shimkus. The g entlelady yields back her time, and we 
want to thank you all. We think it was a great hearing. I want 
to ask unanimous consent that all subcommittee members have 5 
days to submit opening statements for the record. Without 
objection, so ordered. Members will have 10 requisite days to 
submit questions for the record, so if you follow up with 
questions, if you would submit those back to us? I think it is 
very, very important because, as you see, we had a lot of 
active members very interested in this.
    I think it is safe to say that there is need for reform 
across the board. I think there is desire by the stakeholders 
and members. I think also the status quo is really not 
acceptable. I think people concur with that. Cautionary note is 
don't let the perfect be the enemy of the good as we try to 
work through this process.
    And, with that, I want to thank my colleagues for 
attending, and I will now adjourn the hearing.
    [Whereupon, at 12:07 p.m., the subcommittee was adjourned.]

                                 [all]
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