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



 
                TITLE I OF THE TOXIC SUBSTANCES CONTROL 
                   ACT: UNDERSTANDING ITS HISTORY AND
                   REVIEWING ITS IMPACT
=======================================================================

                                HEARING

                               BEFORE THE

              SUBCOMMITTEE ON ENVIRONMENT AND THE ECONOMY

                                 OF THE

                    COMMITTEE ON ENERGY AND COMMERCE
                        HOUSE OF REPRESENTATIVES

                    ONE HUNDRED THIRTEENTH CONGRESS

                             FIRST SESSION

                               __________

                             JUNE 13, 2013

                               __________

                           Serial No. 113-54



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                    COMMITTEE ON ENERGY AND COMMERCE

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

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

                              ----------                              
                                                                   Page
Hon. John Shimkus, a Representative in Congress from the State of 
  Illinois, opening statement....................................     1
    Prepared statement...........................................     2
Hon. Paul Tonko, a Representative in Congress from the State of 
  New York, opening statement....................................     3
Hon. Henry A. Waxman, a Representative in Congress from the State 
  of California, opening statement...............................    24

                               Witnesses

Kathleen M. Roberts, Vice President, B&C Consortia Management, 
  LLC............................................................     4
    Prepared statement...........................................     7
Charles M. Auer, Principal, Charles M. Auer & Associates, LLC....    25
    Prepared statement...........................................    28
    Answers to submitted questions...............................   129
Alfredo Gomez, Director, Natural Resources and Environment, 
  Government Accountability Office...............................    50
    Prepared statement...........................................    52
    Answers to submitted questions...............................   134
Beth D. Bosley, President, Boron Specialties, LLC................    76
    Prepared statement...........................................    78
    Answers to submitted questions...............................   138
Daniel Rosenberg, Senior Attorney, Health and Environment 
  Program, Natural Resources Defense Council.....................    85
    Prepared statement...........................................    88
    Answers to submitted questions...............................   145
Jeanne Rizzo, President and CEO, Breast Cancer Fund..............    99
    Prepared statement...........................................   101
    Answers to submitted questions...............................   157


TITLE I OF THE TOXIC SUBSTANCES CONTROL ACT: UNDERSTANDING ITS HISTORY 
                        AND REVIEWING ITS IMPACT

                              ----------                              


                        THURSDAY, JUNE 13, 2013

                  House of Representatives,
       Subcommittee on Environment and the Economy,
                           Committee on Energy and Commerce
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:16 a.m., in 
room 2322 of the Rayburn House Office Building, Hon. John 
Shimkus (chairman of the subcommittee) presiding.
    Members present: Representatives Shimkus, Pitts, Murphy, 
Harper, Cassidy, Bilirakis, Johnson, Tonko, Green, DeGette, 
Capps, McNerney, Barrow, and Waxman (ex officio).
    Staff present: Charlotte Baker, Press Secretary; Jerry 
Couri, Senior Environmental Policy Advisor; Kirby Howard, 
Legislative Clerk; David McCarthy, Chief Counsel, Environment 
and the Economy; Tina Richards, Counsel, Environment; Chris 
Sarley, Policy Coordinator, Environment and the Economy; 
Jacqueline Cohen, Democratic Counsel; Greg Dotson, Democratic 
Staff Director, Energy and Environment; Elizabeth Letter, 
Democratic Assistant Press Secretary; Stephen Salsbury, 
Democratic Special Assistant; and Ryan Skukowski, Democratic 
Staff Assistant.

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

    Mr. Shimkus. This subcommittee will come to order. I will 
recognize myself for 5 minutes for my opening statement.
    Today's hearing is on Title I of the Toxic Substances 
Control Act: Understanding its History and Reviewing its 
Impact. TSCA Title I addresses chemical substances and mixtures 
in commerce. Title I gives EPA extraordinary authority to 
regulate manufacturing and interstate commerce affecting 
chemical substances and mixtures, from their manufacture, 
processing and distribution in commerce, to their use and 
disposal.
    TSCA is not your garden-variety environmental law. To help 
place the size and scope of it into context, the American 
Chemistry Council estimates based on the Numerical List of 
Manufactured Products prepared by the Census Bureau, more than 
96 percent of all manufactured goods are touched by the 
business of chemistry and the activities potentially regulated 
by EPA under TSCA. Title I of TSCA has remained largely 
unchanged for 37 years. Mr. Dingell has been here longer than 
that, though most have not. Indeed, many of the nuts and bolts 
of TSCA policy evolution have occurred outside the legislative 
context.
    Legislation recently introduced in the other body has 
heightened interest in congressional action on TSCA. I, for 
one, think we should closely examine TSCA and be open to 
legislation to update and reform it. Any attempt to do so from 
our end should start with fundamental oversight of how TSCA is 
designed and operated. With many new members on this committee 
and subcommittee, today's hearing is the first installment 
towards that end.
    Let us start by asking the following questions: What 
authorities does EPA have under TSCA? What is TSCA's practical 
legal reach? How many chemicals are currently in commerce? How 
wide is TSCA's regulatory reach concerning chemicals in the 
commercial universe? Which authorities is EPA using? Which 
authorities is EPA not using? How do TSCA authorities relate to 
one another and to other federal laws? What activities are 
currently being carried out under TSCA? What parts of TSCA do 
or do not work well? Are there legal gaps in TSCA? How does EPA 
currently set an agenda for reviewing chemicals? Does it need 
legal authority to do so? What is the history and extent of 
information protection under TSCA? What are the issues that 
come with it?
    Thanks to our distinguished witnesses for joining us today 
to help us get a better handle on what the law is, how EPA has 
been implementing it, what it is like being regulated under it, 
and where witnesses think its successes and failures lie.
    I urge members to make every effort at this hearing to 
learn the fundamentals of current law. That is the purpose of 
today's hearing, rather than to argue for or against any TSCA 
reform legislation.
    I now yield 5 minutes to the ranking member of our 
subcommittee, Mr. Tonko from New York.
    [The prepared statement of Mr. Shimkus follows:]

                Prepared statement of Hon. John Shimkus

    Today's hearing is on Title I of the Toxic Substances 
Control Act: Understanding its History and Reviewing its 
Impact. TSCA Title I addresses chemical substances and mixtures 
in commerce.
    Title I gives EPA extraordinary authority to regulate 
manufacturing and interstate commerce affecting chemical 
substances and mixtures, from their manufacture, processing, 
and distribution in commerce, to their use and disposal.
    TSCA is not your garden variety environmental law. To help 
place the size and scope of it into context, the American 
Chemistry Council estimates based on the Numerical List of 
Manufactured Products prepared by the Census Bureau more than 
96 percent of all manufactured goods are touched by the 
business of chemistry and the activities potentially regulated 
by EPA under TSCA.
    Title I of TSCA has remained largely unchanged for 37 
years. Indeed, many of the nuts and bolts of TSCA policy 
evolution have occurred outside the legislative context.
    Legislation recently introduced in the other body has 
heightened interest in congressional action on TSCA. I, for 
one, think we should closely examine TSCA and be open to 
legislation to update and reform it. Any attempt to do so from 
our end should start with fundamental oversight of how TSCA is 
designed and operated. With many new members on this committee 
and subcommittee, today's hearing is the first installment 
towards that goal.
    Let's start by asking the following questions:
    1.) What authorities does EPA have under TSCA?
    2.) What is TSCA's practical legal reach?
    3.) How many chemicals are currently in commerce?
    4.) How wide is TSCA's regulatory reach concerning 
chemicals in the commercial universe?
    5.) Which authorities is EPA using?
    6.) Which authorities is EPA not using?
    7.) How do TSCA authorities relate to one another and to 
other federal laws?
    8.) What activities are currently being carried out under 
TSCA?
    9.) What parts of TSCA do or do not work well?
    10.) Are there legal gaps in TSCA?
    11.) How does EPA currently set an agenda for reviewing 
chemicals? Does it need legal authority to do so?
    12.) What is the history and extent of information 
protection under TSCA? What are the issues that come with it?
    Thanks to our distinguished witnesses for joining us today 
to help us get a better handle on what the law is, how EPA has 
been implementing it, what it's like being regulated under it, 
and where witnesses think its successes and failures lie.
    I urge members to make every effort at this hearing to 
learn the fundamentals of current law. That's the purpose of 
today's hearing, rather than to argue for or against any TSCA 
reform legislation.

                                #  #  #

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

    Mr. Tonko. Thank you, Chair Shimkus. Good morning, 
everyone, and thank you, Mr. Chair, for holding this hearing on 
the Toxic Substances Control Act, better known as TSCA. I 
understand the subcommittee will be holding additional hearings 
on this program. I look forward to hearing from additional 
witnesses on this very important topic.
    We have all heard the stats related to chemical production 
and use. Some 80,000 chemicals are in use with hundreds of new 
chemicals coming into production every year. The advances in 
chemistry and biology and the adoption of new manufacturing 
processes over the past decade have shortened the time 
necessary for development and manufacture of new chemicals.
    There are many benefits to this progress, and some 
challenges. The line between chemistry and biology has become 
much less definitive. We should give some consideration to how 
well current law is suited to evaluate new chemicals in light 
of these new developments. This law has been with us now for 
many years, enough years to provide us with ample experience of 
its application and its utility.
    The law has not lived up to expectations. It has not 
provided a sufficient amount of information for the public 
about the potential hazards of chemicals that they encounter in 
their daily lives. There are many chemicals in commerce today 
that have very little information about their potential risks 
to human health or the environment. Some have none at all.
    Successive Administrations have devised policies to reduce 
the backlog of chemical assessments. None of these efforts have 
been very successful. The law has also proven ineffective at 
removing harmful chemicals from the market. Congress had to 
take separate action to eliminate PCBs and asbestos when 
mounting evidence demonstrated the problems with these 
chemicals. It is not a good track record.
    If we have safer alternatives to chemicals on the market, 
the Environmental Protection Agency should be able to act in a 
timely fashion to remove harmful substances, making way for 
safer products to move into commerce. I am certain we will hear 
about all of these issues this morning from our expert team of 
witnesses.
    I recognize there are several proposals introduced in the 
Senate to amend this law. This hearing and the additional one 
to come will provide us a solid base from which to evaluate 
these proposals against current law.
    I look forward to the testimony of our witnesses again here 
today, and I thank you all for being here to share your views 
on what is a very important topic.
    With that, I yield back. Thank you, Mr. Chair.
    Mr. Shimkus. The gentleman yields back his time. Is there 
anyone else seeking recognition for an opening statement on the 
majority side? Is there anyone seeking recognition on the 
minority side? Seeing no one, we will then move to our panel. 
We would like to welcome you all here. All your statements have 
been submitted for the record. You will be given 5 minutes to 
give your oral statement. We are not going to be punitive in 
punishing but don't go too long because this is a large panel. 
Just for your information, there is another committee hearing 
going on on the first floor. Members will be coming up and down 
for that. You are competing with the Secretary of Energy. You 
can see where I am. Many members are down there trying to get 
their licks in on him. Let me start by recognizing and 
welcoming Kathleen Roberts, who is the Vice President of B&C 
Consortia Management LLC. You are recognized for 5 minutes.

 STATEMENTS OF KATHLEEN ROBERTS, VICE PRESIDENT, B&C CONSORTIA 
MANAGEMENT, LLC; CHARLES M. AUER, PRINCIPAL, CHARLES M. AUER & 
ASSOCIATES, LLC; ALFREDO GOMEZ, DIRECTOR, NATURAL RESOURCES AND 
  ENVIRONMENT, GOVERNMENT ACCOUNTABILITY OFFICE; BETH BOSLEY, 
  PRESIDENT, BORON SPECIALTIES, LLC; DANIEL ROSENBERG, SENIOR 
  ATTORNEY, HEALTH AND ENVIRONMENT PROGRAM, NATURAL RESOURCES 
 DEFENSE COUNCIL; AND JEANNE RIZZO, PRESIDENT AND CEO, BREAST 
                          CANCER FUND

                 STATEMENT OF KATHLEEN ROBERTS

    Ms. Roberts. Thank you, Chairman Shimkus, Ranking Member 
Tonko, members of the subcommittee. I am here today to provide 
a brief overview of the regulatory program under the Toxic 
Substances Control Act, a TSCA 101, if you will.
    I have spent more than 20 years with chemical companies to 
understand and comply with TSCA. I was with the American 
Chemistry Council for 17 years, and I have been with Bergeson 
and Campbell for 4 years, where I work as a non-attorney 
professional. As stated, I currently am Vice President of 
Bergeson and Campbell's affiliate B&C Consortia Management. My 
remarks today are on my own behalf and do not necessarily 
reflect the views of Bergeson and Campbell, B&C Consortia 
Management or any of their clients.
    In my view, the regulatory process under TSCA is logical 
and almost element in its simplicity. New chemicals must be 
notified to EPA. This is a small, very simple flow chart trying 
to show how they connect. New chemicals must be notified to 
EPA. For any chemical on the TSCA inventory, EPA can gather 
information through Section 8. If more information is needed, 
EPA can require testing under Section 4. If there are still 
concerns, EPA can apply necessary risk management controls 
through Sections 5 or 6.
    When TSCA was first enacted, companies informed EPA which 
chemicals were produced or imported into the United States at 
that time. This resulted in the initial TSCA inventory and was 
issued in 1979. These chemicals are also often referred to as 
grandfathered chemicals. Any chemical that was developed and 
marketed after 1979 has gone through a New Chemical Assessment 
under Section 5. This involves the submission of a 
Premanufacture Notice that includes information on chemical 
identity, description of byproducts, anticipated production 
volumes, molecular formula, intended categories of use, and 
other available information. EPA's decision options for PMN-
subject chemicals are: entry into commerce not allowed, entry 
into commerce allowed with no restrictions, entry into commerce 
allowed after submission of additional data, or entry into 
commerce allowed with certain regulatory or testing actions 
applied.
    Assuming EPA has allowed the chemical to enter into 
commerce, the manufacturer typically submits a Notice of 
Commencement, and at that time the new chemical is added to the 
TSCA inventory and becomes an existing chemical. All existing 
chemicals, meaning all those listed on the TSCA inventory, are 
subject to regulations under 4, 5, 6 and 8. There are other 
sections of TSCA that also apply to existing chemicals but in 
the brevity of time I will not try to go through all of them.
    Section 8, as I mentioned, is focused on information 
collection. Section 8(a) authorizes EPA to issue rules 
requiring companies to submit information on categories of use, 
quantities produced or imported, and/or health and 
environmental effects. As of 2006, EPA has issued 33 8(a) rules 
covering about 1,200 chemicals.
    Also under Section 8(a) is the Chemical Data Reporting 
Rule. This is an existing cyclical reporting cycle under which 
manufacturers and importers are required to report production, 
process and use information for chemicals manufactured or 
imported over 25,000 pounds per year at a single site. The last 
reporting cycle was in 2012, and information on about 7,700 
chemicals was submitted. Section 8(c) requires companies to 
record and retain allegations of significant reactions to any 
chemical substance. If EPA issues an 8(c) data call-in, 
companies are required to submit that information to EPA. Only 
two such data call-ins have been issued.
    Section 8(d) authorizes EPA to issue rules requiring 
companies to submit lists or copies of ongoing and completed 
unpublished studies. As of 2006, EPA has issued 51 8(d) rules 
on about 1,200 chemicals resulting in about 50,000 studies 
being submitted to EPA on a broad range of end points.
    Under TSCA 8(e), entities are required to immediately 
report information that reasonably supports the conclusion that 
a chemical substance presents a substantial risk. As of 2006, 
there were about 16,500 8(e) notices submitted. According to 
EPA statistics, about 200 notices are submitted per year. EPA 
can use the information collected or submitted under these 8(c) 
provisions to identify whether a particular chemical is of 
concern or if more information is needed. If that is the case, 
EPA can use its Section 4 authority to issue test rules 
requiring companies to conduct tests on certain chemicals. EPA 
has required testing for about 200 chemicals under Section 4 or 
under its enforceable consent agreement options. Keep in mind, 
however, that as I have mentioned, EPA can require testing as 
part of that new chemical review, and that has occurred for 
about 300 chemicals.
    Section 6 authorizes EPA to issue rules to manage risks for 
existing chemicals. Risk management options include 
restrictions on production levels, restrictions for certain 
uses, restrictions on releases to environments, warning labels 
and the like.
    As noted earlier, under Section 5, EPA is authorized to 
issue restrictions on new chemicals. They also can be applied 
to existing chemicals pursuant to EPA's Significant New Use 
authority. While only six chemicals have been subjection to 
Section 6 requirements, EPA has applied restrictions to 
thousands of chemicals through Section 5.
    I would like to briefly highlight three challenges or three 
areas that I think there may be some issues with. In my view, 
EPA has been particularly constrained when trying to use its 
TSCA authorities that require rulemakings. These challenges 
aren't necessarily unique to TSCA rulemakings as I think all 
rulemakings are fairly cumbersome and often take 3 to 5 years. 
Likewise, while I see great output from EPA's New Chemical 
Review process, there is less so in the existing chemical 
arena. In my view, that may be because the new chemical 
notification has a statutory review period of 90 days. There is 
nothing similar in the existing chemicals program.
    And finally, I would like to touch on the issue of 
confidential business information as that is often raised as a 
red flag for TSCA. Keep in mind that TSCA compels chemical 
companies to provide a wealth of sensitive data. For example, 
companies have to provide detailed information on how chemicals 
are processed and manufactured. And while there are clearly 
legitimate needs for EPA to have this type of information to 
achieve its statutory goals, I believe there are also very 
legitimate needs for companies to have that information 
protected as confidential.
    Thank you so much for this esteemed opportunity. I would be 
pleased to answer any questions.
    [The prepared statement of Ms. Roberts follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Shimkus. Thank you very much.
    If the panel will hold for a minute, we welcome the ranking 
member of the full committee, Mr. Waxman. Without objection, I 
would like to allow him to give his opening statement. Then we 
will return to the panel. It is always good to take care of the 
ranking member of the full committee. So with that, I recognize 
Mr. Waxman for 5 minutes.

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

    Mr. Waxman. Thank you very much, Mr. Chairman. I thank the 
panel for allowing me to give my opening statement, even though 
you have already started your presentations to us.
    I want to commend the chairman for holding this hearing, 
which begins our committee's work on the Toxic Substances 
Control Act. TSCA is an important law because of its role in 
protecting the American public from dangerous chemicals, and it 
is long overdue for strengthening.
    In recent years, EPA has undertaken a serious effort to 
reform TSCA through the exercise of its regulatory authorities. 
The Agency has formulated action plans for ten chemicals and 
classes of chemicals, which are some of the most dangerous 
chemicals on the market, and Agency deserves credit for those 
efforts.
    But EPA's authority is limited and progress has been slow, 
even for the chemicals that are the worst of the worst. Four 
years ago, there was widespread agreement among industry, labor 
and nongovernmental organizations that TSCA needs to be 
reformed. The EPA Administrator said that TSCA had proven to be 
``an inadequate tool for providing the protection against 
chemical risks that the public rightfully expects.''
    The American Chemistry Council said it wanted to work with 
``stakeholders, Congress, and the Administration to make reform 
a reality.'' And a coalition of public interest groups said 
that ``By updating TSCA, Congress can create the foundation for 
a sound and comprehensive chemicals policy that protects public 
health and the environment, while restoring the luster of 
safety to U.S. goods in the world market.''
    The Committee put considerable effort into building on this 
consensus and modernizing TSCA. In 2009 and 2010, we held 
numerous hearings and convened a robust stakeholder process. We 
examined what testing should be required for all chemicals, how 
information should be protected, and what safety standard 
chemicals should be required to meet. While we made 
considerable progress, we did not complete the job. And that is 
why this hearing and the future ones to come are so important.
    We need to hear from all stakeholders and work together, if 
we can, to modernize this important environmental law. Even 
with recent progress towards bipartisan cooperation, we have 
significant work ahead of us to achieve that goal, but it is 
certainly a worthy goal for this Congress.
    I thank all of the witnesses for being here today. I look 
forward to hearing your testimony. I want to apologize that I 
am not going to be here the whole time because I have no 
control over the schedule, and we have another subcommittee 
meeting at the same time with the Secretary of Energy and I am 
trying to be back and forth. If I am not here to hear your 
testimony, I will probably be here to ask you questions about 
your testimony because our staff has had a chance to review it 
in advance.
    Thank you, Mr. Chairman, for allowing me to make this 
statement, and I yield back.
    Mr. Shimkus. The gentleman yields back his time.
    The chair now recognizes Mr. Charles Auer, Principal, 
Charles Auer & Associates LLC, so you are recognized for 5 
minutes.

                  STATEMENT OF CHARLES M. AUER

    Mr. Auer. Thank you, Mr. Chairman. I thank you for this 
opportunity to provide an oral summation of my written 
testimony to this TSCA hearing--I do have a copy of the law. It 
is very old, an original copy--before the Subcommittee on the 
Environment and the Economy. I am pleased to be part of this 
esteemed panel. I also appreciate and note the chairman's 
statement of openness to reform. Thank you for that. Very 
important.
    As outlined in my testimony, I was a long-time EPA employee 
who worked on TSCA issues for over 30 years. I am a chemist by 
training, and at my retirement held the position of director of 
the EPA office responsible for TSCA implementation. I left EPA 
in early 2009 and now work as a consultant for a variety of 
clients including companies, trade associations and others. I 
note that my testimony is mine alone and that I am not speaking 
for or on behalf of anyone else.
    The first section of my testimony provides an overview of 
TSCA's authorities, which Kathleen has nicely covered. The 
second section reviews available statistics relating to various 
TSCA provisions and attempts to describe the footprint of 
regulatory and voluntary actions taken by EPA. The section 
explores several sections including how many new chemicals have 
been submitted to and been regulated by EPA. Available 
statistics indicate that about 48,000 new chemicals have been 
notified to EPA including as Premanufacture Notifications and 
as regulatory exemptions under Section (5)(h)(4).
    As I thought about my testimony, I came to several 
realizations, and one of these is that over 15,000 new 
chemicals have received some kind of regulatory action under 
TSCA. I am sure this is news to most people in the room. This 
includes action under Section 5(e) as a consent order, a 
Significant New Use Rule, a section 5(h)(4) regulatory 
exemption or a voluntary withdrawal action. I have included the 
Section 5(h)(4) exemption chemicals in this list because the 
exemptions process requires a grant or deny determination by 
EPA and the chemicals are legally subject to the terms of the 
exemption. One aspect that can be confusing is that the use of 
the term ``exemption'' refers to a chemical being exempted from 
the normal new chemicals process and instead such new chemicals 
are subject to the exemption process. Note also that companies 
choose to go the exemption route because it combines timeliness 
and certainty. EPA will decide within 30 days, for example. And 
EPA likes them because it produces an acceptable outcome 
without a protracted negotiation. Voluntary withdrawals by the 
company are included because this is often done in the face of 
possible EPA regulation.
    This set of 15,000 new chemicals regulated represents over 
30 percent of all new chemicals submitted to EPA under TSCA, 
and as I noted, this is an interesting statistic that I even 
though I had been in the program for lo these many years had 
not previously appreciated.
    How many existing chemicals have been tested or were the 
focus of risk management efforts? The story is not so good 
here. About 200 chemicals were tested under Section 4, and a 
small number, a very small number of chemicals were regulated 
under TSCA in section 6 including PCBs. However, it is useful 
to note, EPA has also used Section 5(a)(2), Significant New Use 
Rule authority, in regulating over 300 existing chemicals 
including PBTs, carcinogens and other toxic or risky chemicals, 
and among those are some very well known bad actors. See my 
testimony for details.
    The third section discusses relevant TSCA sections with an 
eye to exploring which aspects have worked or not worked. Areas 
that I suggest have worked include the initial creation and 
maintenance of the inventory, the new chemicals program and the 
citizens petition process. The existing chemical programs on 
testing and management are identified and discussed as areas 
that did not work very well, although as alluded to in my 
testimony, some very good outcomes have been obtained under 
both Democratic and Republican Administrations. With that, let 
me step back for a moment.
    This is not a partisan issue although important principles 
are at play. The issue is, however, complex, and that 
complexity needs to be both recognized and be respected. 
Getting it right is critical and essential to protecting health 
and the environment while assuring the future competitiveness 
of the United States. To achieve these goals, the final product 
of any TSCA reform effort, in my view, must be workable and 
effective for both EPA and the regulated industry. Back on 
testimony.
    With regard to legal gaps, I note that while Sections 4 and 
6 may not rise to legal gaps in authority, although I suspect 
others might differ, there is a need to strengthen and improve 
these authorities. Concerning actual legal gaps, I point to the 
need for implementing legislation if the United States is to 
join treaties such as Rotterdam and Stockholm. I also suggest 
TSCA revision to allow appropriate sharing with and receiving 
of confidential business information from State and possibly 
foreign governments that satisfy legal requirements. I note 
that both Canadian and EU law allow for such sharing with other 
national governments.
    The fourth and last section reviews the history of EPA's 
effort to set an agenda for reviewing existing chemicals, and I 
attempt to answer the question: why haven't these earlier 
attempts worked? I observed that a key issue is the way that 
TSCA provides broad authority but vague priority to guide EPA's 
work.
    Mr. Shimkus. Sir, we need you to move a little bit quicker.
    Mr. Auer. Further, I opine that EPA could do a better, more 
effective job if it had appropriate policy guidance outlining 
what among the various possibilities EPA should be doing. I 
briefly elaborate on a series of underlying points. I also 
recount that despite several attempts by EPA to create an 
agenda over the decades, it has proven difficult for EPA to 
figure the issue out on its own. In fact, it sometimes appears 
that EPA is always initiating a new approach. See GAO's 
testimony. And I take note of Mr. Tonko's useful comment in 
this regard, which helps to make the case for one of the 
central arguments in my testimony.
    I respectfully note that Congress has not shown much 
interest in TSCA over the statute's history. This is part of 
the problem.
    Mr. Shimkus. You are going to have to sum up.
    Mr. Auer. All right. I will do my best. I mean, I think 
this is important.
    Mr. Shimkus. Well, why don't we just--we will go to 
questions, and once you get asked questions.
    Mr. Auer. Let me----
    Mr. Shimkus. You are 3 minutes, almost 4 minutes over time.
    Mr. Auer. I thought that was how much time I had left.
    Mr. Shimkus. No. We have been overly compassionate here.
    [The prepared statement of Mr. Auer follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Shimkus. We will pause here. We will move to our next 
panelist and hopefully through the questions and answers we can 
ferret out some of your other fine points that you want to 
make.
    So the chair now recognizes Alfredo Gomez, Director, 
Natural Resources and Environment for the Government 
Accountability Office. Sir, you are recognized for 5 minutes, 
and maybe a minute or two over.

                   STATEMENT OF ALFREDO GOMEZ

    Mr. Gomez. Mr. Chairman, Ranking Member Tonko, members of 
the subcommittee. I am pleased to be here today to discuss 
EPA's implementation of TSCA.
    Tens of thousands of chemicals are listed with the EPA for 
commercial use in the United States with an average of 600 new 
ones added each year. Although chemicals are important in 
producing goods and services, some may adversely affect human 
health and the environment. Congress passed TSCA to give EPA 
the authority to obtain more health and safety information on 
chemicals and to regulate chemicals it determines post 
unreasonable risks of injury, to human health or the 
environment. EPA's authority is established in five major 
sections of TSCA, some of which have already been discussed.
    My statement today summarizes GAO's past work, describing 
challenges EPA has historically faced in regulating chemicals, 
and the extent to which EPA has made progress in implementing 
its new approach.
    I would like to begin by focusing on three of the biggest 
challenges EPA has faced in implementing TSCA. First, under 
Section 4 of TSCA, EPA has found it difficult to obtain 
adequate information on chemical toxicity and exposure because 
TSCA does not require companies to provide this information. 
Instead, the law requires EPA to demonstrate the chemicals pose 
certain risks before it can ask for such information. In June 
2005, we reported that while TSCA authorizes EPA to review 
existing chemicals, the statute generally provides no specific 
requirement, time frame or methodology for doing so. We 
suggested that Congress consider amending TSCA to provide EPA 
explicit authority to enter into enforceable agreements 
requiring chemical companies to conduct testimony and to 
require chemical manufacturers and processors with substantial 
production value to develop test data.
    Second, under Section 6, EPA has also had difficulty 
demonstrating that chemicals should be banned or have limits 
placed on their production or use. We reported that since 
Congress enacted TSCA in 1976, EPA has issued regulations to 
ban or limit the production or restrict the use of only five 
existing chemicals or chemical classes out of tens of thousands 
of chemicals listed for commercial use. EPA told us that even 
if EPA had substantial toxicity and exposure data and wants to 
protect the public against known risks, the Agency's challenge 
is meeting this statutory requirement under TSCA to limit or 
ban chemicals.
    Third, under Section 14, EPA has limited ability to 
publicly share the information it receives from chemical 
companies. While companies assert that their information is 
confidential business information, EPA is limited from sharing 
it with States and foreign governments. This potentially limits 
the effectiveness of these organizations' environmental risk 
programs. We reported that EPA had not routinely challenged 
companies' confidentiality claims.
    EPA has made some progress in implementing its new approach 
to managing chemicals while results in other areas have yet to 
be realized. For example, EPA has increased its efforts to 
obtain chemical toxicity and exposure data and initiating 
chemical risk assessments. However, it may take several years 
before EPA obtains much of the data it is seeking. Moreover, 
given the difficulty that EPA has faced in the past using 
Section 6 of TSCA, since 2009 EPA has taken other actions that 
may discourage the use of certain chemicals, some of which have 
already been mentioned. However, it is too early to tell 
whether some of these actions will reduce chemical risks.
    Thus, it is unclear whether EPA's new approach will 
position the agency to achieve its goal of ensuring the safety 
of chemicals. EPA officials have said that the Agency's new 
approach is summarized in its 2012 Existing Chemicals Program 
Strategy. However, this strategy does not discuss how EPA will 
address challenges associated with obtaining toxicity and 
exposure data, banning or limiting the use of chemicals, or 
identifying the resources needed. We recommended that EPA 
develop strategies for addressing these challenges. In 
response, EPA said that while strategic planning is a useful 
exercise, absent statutory changes to TSCA, the Agency will not 
be able to successfully meet the goal of ensuring chemical 
safety now and into the future.
    This completes my statement. I would be pleased to respond 
to any questions.
    [The prepared statement of Mr. Gomez follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Shimkus. Thank you.
    The chair now recognizes Beth Bosley, President of Boron 
Specialties, LLC. You are recognized for 5 minutes.

                    STATEMENT OF BETH BOSLEY

    Ms. Bosley. Good morning, and thank you for inviting me 
here today. I am the President of Boron Specialties. We are a 
small fine-chemical manufacturer. We are passionate about 
making our products here in the United States, and we currently 
invest every dollar we make into accelerating our growth. We 
are very small, only six people altogether. We are also 
committed to responsible operation of our business including 
environmental stewardship and regulatory compliance, very 
important to me personally as a business owner. It is in the 
spirit of running a globally competitive business while 
protecting health and safety of our employees and the public 
that I speak to you today about TSCA.
    At the outset, I would like to make three general points on 
my perspective on how to update TSCA. First, TSCA is a law 
regulating chemical substances, not food, not drugs, and not 
pesticides. TSCA gives EPA the regulatory authority to regulate 
unreasonable risk to human health and the environment. It also 
regulates a broad range of chemicals. Many of those chemicals 
are industrial chemicals, and by that, I mean chemicals that 
are sold between chemical companies but not necessarily part of 
consumer products and not necessarily with any exposure to the 
public.
    The second point to bear in mind is the concept of risk. 
Risk is a combination of two things. It is both hazard and 
exposure, and one of EPA's jobs under TSCA is to do risk 
assessments and to make judgments about whether reasonably 
anticipated uses of chemicals would present sufficient 
probability of harm to people or the environment, and if so, 
then they are to restrict those uses.
    Finally, smart regulation can and should achieve its 
objectives without inhibiting innovation. American companies 
like mine are on the cutting edge of chemical innovation. TSCA 
has allowed us to lead the world in this regard. Any amendments 
to TSCA must preserve time frames and flexibility but allow 
this innovation to continue. They must also protect 
confidential business information that is at the heart of all 
innovation.
    It is really easiest to look at TSCA in terms of existing 
and new chemicals, and you have heard a little bit about that 
already this morning. New chemicals are any that are not in 
commerce currently, and prior to manufacturing those new 
chemicals, companies like mine must submit what it is called a 
Premanufacture Notice, or PMN, and submitted PMNs must provide 
all the data that they have or that they can reasonably 
ascertain about a chemical substance, and while it is true that 
upfront testing is not required, EPA is able to employ 
predictive technologies which interprets quite conservatively 
to help decide if a new chemical raises concern. Through the 
new chemicals program, EPA reviews roughly 2,000 chemicals 
every year, and that really reflects the state of innovation in 
the United States. It is also worth considering that new 
chemicals are often greener than those that they are replacing 
since minimizing a company's eco footprint is really a driver 
for innovation.
    Existing chemicals are those, as you have heard, that are 
already on EPA's inventory. The inventory consists of chemicals 
that were in commerce in the late 1970s plus the chemicals that 
EPA has reviewed through the new chemicals program. It is often 
referred to as over 80,000 substances. However, EPA's 2012 
survey concluded that fewer than 8,000 chemicals are actively 
in commerce, and that is defined as being manufactured at a 
rate of 12\1/2\ tons per year at any single site in the United 
States. While the current TSCA regulation grants EPA the 
authority, the Agency has no mandate to assess existing 
chemicals, as I think you have heard from every person on the 
panel so far. Not surprisingly, non-mandated programs lose out 
in the competition for budget resources.
    Furthermore, when EPA does identify existing chemicals on 
which it needs more data, it has to go through a time-consuming 
rulemaking process to request testing, even when companies 
might be in full agreement with that testing. EPA has developed 
work-around mechanisms to collect the information that it 
needs, and those are voluntary programs and consent agreements, 
which industry participates in.
    Section 6 authorizes EPA to restrict chemicals that present 
an unreasonable risk, and this authority has seldom been used 
and is at the center of the debate over TSCA. EPA's ability to 
restrict existing chemicals that do not meet a safety standard 
could be improved by eliminating some of these significant 
procedural burdens. While this section certainly needs 
improvement, and it is true that few chemicals have been 
restricted under it, be mindful that chemicals may be regulated 
under other sections of TSCA as well. As a matter of fact, most 
chemicals can be and are used safely. This is why rather than 
banning substances outright, EPA has opted to restrict their 
uses instead.
    The provision on confidential business information in 
Section 14 has historically worked well to protect trade 
secrets and promote innovation. However, many of the claims 
have gone unchecked, creating a negative stigma around the 
concept of CBI. Protecting information regarding chemical 
identity and process technology are essential to maintain a 
competitive edge for innovative U.S. manufacturers but there 
are improvements that can absolutely be made to the CBI 
process. And please bear in mind that EPA staff sees all 
information, whether or not it is labeled as CBI.
    As a specialty chemical manufacturer and a small business, 
I can say unequivocally that protection of chemical identity 
can be critical. Given the narrow application for which 
specialty chemicals are used and the niche markets they serve, 
disclosure of chemical identity may be all it takes to give 
away a competitive advantage to an offshore manufacturer. The 
majority of Freedom of Information Act requests to EPA come 
from companies, many of which are overseas, not curious members 
of the public. This Act underscores the real threat of losing 
America's innovative advantage.
    That concludes my oral testimony, and I would be happy to 
take any questions.
    [The prepared statement of Ms. Bosley follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Shimkus. Thank you very much.
    Now the chair recognizes Mr. Daniel Rosenberg, Senior 
Attorney under the Health and Environment Program of the 
Natural Resources Defense Council. Sir, you are recognized for 
5 minutes.

                 STATEMENT OF DANIEL ROSENBERG

    Mr. Rosenberg. Thank you, Chairman Shimkus and Ranking 
Member Tonko and members of the committee. Thank you for the 
opportunity to testify today. It is good to see the committee 
reengaging on this issue.
    To be blunt, TSCA is widely recognized as a failure. It has 
not enabled EPA to protect the public or even to assess the 
risks the public may face from many commonly used chemicals. It 
has not provided the confidence that chemical manufacturers 
desire from their consumers and retailers. It is no wonder the 
EPA, the GAO, scientists, health advocates, doctors and 
business leaders are all calling for reform.
    TSCA is riddled with fundamental structural flaws. Other 
environmental laws, though controversial, have been fair more 
effective. Perhaps the greatest original sin under TSCA was to 
grandfather the 62,000 chemicals on the market in 1976. There 
was no requirement for EPA to review those chemicals or to hold 
them to any safety standard. In nearly 35 years, EPA has 
managed to require testing of only about 200 of those 
substances, and has partially regulated only five. That is a 
problem because it means that chemicals that are known to cause 
harm including cancer, learning disabilities and reproductive 
problems in animals or humans remain in widespread use.
    And many chemicals are in use for which we don't have 
sufficient information to know whether or not they are safe. 
This is a public health concern, particularly considering the 
rising rates of cancer, mental illness and other chronic 
diseases in our country. One in two men develop an invasive 
cancer and one in four die from cancer--one in four men in the 
United States. One in three women develop invasive cancers, and 
one in five die. Roughly 1.5 million people in the United 
States are diagnosed with cancer each year. The CDC just 
released a study of mental illness in children and found 13 to 
20 percent, 7 to 12 million, have mental health disorders 
including ADHD, mood and anxiety disorders, and autism spectrum 
disorders. Those rates are rising.
    EPA's ability to fully assess and regulate chemicals is not 
much better for the approximately 22,000 chemicals that have 
been brought to market since TSCA was enacted. The law gives 
EPA only a brief period--3 to 6 months--to review new chemicals 
and makes it hard for EPA to get the needed data. Most 
Premanufacture Notices are submitted to the Agency without any 
data on health or environmental effects. EPA has taken steps to 
fill the gaping holes in its authority and clear the high 
hurdles set by the statute, but that is not an adequate 
substitute for a protective system for reviewing new chemicals.
    But even beyond timing and data requirements, TSCA stacks 
the deck against EPA and public safety. The statute places the 
burden on EPA to prove that a chemical poses a risk and then 
sets a high threshold for making such a finding. This is 
markedly different from other effective health and safety laws. 
Makers of pharmaceuticals and pesticides have to show 
affirmatively that their products are safe, and the food 
quality law, the Food Quality Protection Act, that was passed 
unanimously by a Republican Congress, had a more protective 
risk or safety standard.
    The experience with TSCA teaches the unsurprising but 
essential lesson that laws without enforceable deadlines and 
strong safety standards don't result in action and don't 
protect the public.
    The impotence of TSCA has left a vacuum that has been 
filled by States and retailers. Nineteen States are currently 
regulating chemicals with policies ranging from bans on 
specific uses to disclosure requirements. This does not include 
mercury product bans and other policies adopted in 34 States to 
limit exposure to mercury. In addition, large retailers have 
stopped stocking some products or excluded chemicals from their 
supply chains. While these important actions have increased 
public protection in a piecemeal fashion, they are a 
supplemental but are no substitute for a working federal 
system. States and retailers have had to act, though, because 
of mounting scientific evidence and increasing public concern.
    Scientists know more about the impact of chemicals than in 
1976. There are greater concerns now about the effect chemicals 
can have on our endocrine system and about the potential 
impacts of even small doses of certain chemicals. We also have 
more information about ongoing exposure of hundreds of 
substances due to the development of biomonitoring. The public 
understands this.
    NRDC has commissioned a number of polls to survey public 
opinion on the question of chemical reform. In both our poll 
and those of others, we see strong public support for real TSCA 
reform. Among the findings of our national poll, which is about 
a year old now, over two-thirds of voters, 68 percent, support 
``stricter regulation of chemicals produced and used in 
everyday products.'' This support cuts across every political 
group including majorities of GOP voters--57 percent; 
independence--66 percent, and Democrats--79 percent. The 
support was even stronger for specific legislation to reform 
TSCA. A description of legislation that would require all 
chemical manufacturers to show that their chemicals are safe in 
order to sell them and that EPA would be able to limit some or 
all uses of a chemical that may harm public health or the 
environment yielded 77 percent support with 50 percent strongly 
supporting. Support, again, cut across all political, ethnic, 
gender and regional lines. This is an issue where Washington is 
way behind the people it represents.
    I think TSCA's one clear success has been the phase-out of 
PCBs that was mandated in the original law in 1976. 
Representative Dingell led the fight to include the PCB 
provision in the law, and while PCBs are still very much with 
us and in us, it at least did what the title of the law 
promises: it controlled a toxic substance.
    Congress should learn from that vision and take steps to 
really repair TSCA and protect the public, for example, 
requiring the phase-out of other persistent bioaccumulative and 
toxic PBT chemicals. There are many ways in addition to phasing 
out PBTs to reform TSCA in a way that protects the public and 
also allows the chemical industry to thrive and innovate. We 
would welcome the chance to work with the committee and all 
interested parties to develop such reform.
    Thank you very much for the opportunity to testify.
    [The prepared statement of Mr. Rosenberg follows:]
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    Mr. Shimkus. Thank you.
    The last person on the panel is Ms. Jeanne Rizzo, President 
and CEO of the Breast Cancer Fund, and you are recognized for 5 
minutes.

                   STATEMENT OF JEANNE RIZZO

    Ms. Rizzo. Good morning. Thank you, Chairman Shimkus and 
Ranking Member Tonko and the members of this committee for the 
opportunity to testify and to bring a public health perspective 
to this panel and discussion today.
    At the Breast Cancer Fund, we work to prevent breast cancer 
by eliminating exposure to toxic chemicals and radiation linked 
to the disease. So I am here today on behalf of the 3 million 
breast cancer survivors who are living in this country at the 
moment, 40,000 women and, increasingly, men who will lose their 
lives to breast cancer this year, and I am also here on behalf 
of the millions who are suffering from diseases and conditions 
that have been linked to chemical exposure--birth defects, 
asthma, early puberty, learning disabilities, infertility, 
cancers including breast and prostate--and I am here to state 
from our perspective that in no uncertain terms, the 1976 Toxic 
Substances Control Act is hurting us. As a matter of fact, it 
is killing us but not protecting us, and we have manifestation 
of that in the fact that there are chemicals that are 
transferring into our bodies, into our food, our water, our air 
and even into the umbilical cord of babies.
    That is not what Congress intended back in the 1970s when 
the country was grappling with the public health disaster 
wrought by better living through chemistry. That paradigm, the 
attempt was to fix that. There was really good intention, and 
disease rates were skyrocketing. Scientific evidence was 
mounting. Congress knew then as it does now, I believe, that it 
had to act. So it passed TSCA with great hope that that 
legislation would indeed protect public health. We now, as you 
have heard, have had 37 years of proof that the legislation has 
failed us.
    Look at breast cancer today. Two hundred and twenty-seven 
thousand women will be diagnosed with breast cancer this year, 
and 2,200 men. Women have a one-in-eight lifetime risk of 
breast cancer. That is a 40 percent increase since TSCA's 
passage. We know that only 5 to 10 percent of breast cancer can 
be traced back to inherited genetic factors. There is a 
volcanic amount of scientific evidence that points to 
environmental causes including chemical exposure. We know that 
our genes and our environment collude together to result in 
positive or negative health outcomes.
    We now have to acknowledge TSCA's failure and figure out 
how to design that better, like the fact that the 84,000 
chemicals that are in the TSCA inventory, the 62,000 that were 
grandfathered in. We heard a lot about that today. So chemicals 
could continue to be sold without having to be looked at for 
their long-term impact on health and the environment. The EPA 
under TSCA has only been required to test a certain number of 
those grandfathered chemicals. They have only been able to 
restrict or ban five of them. If TSCA makes it so difficult to 
regulate a chemical that the EPA couldn't even ban asbestos, a 
very well-known carcinogen with a disease named after it, then 
clearly we have not accomplished the goal.
    So we have to take seriously our new knowledge that timing 
of exposure to chemicals matters, that low dose of chemical 
exposures matters, and that mixtures matter, and that is our 
real-life experience. So there is emerging science, the growing 
consensus that TSCA must be reformed.
    In my written testimony, I refer to three major federal 
reports that I encourage reading as well as the 2009 GAO report 
that talked about the fact that although TSCA is authorized to 
ban or limit chemicals, the threshold is prohibitively high. 
And we see States around the country, as you have heard before 
today, taking action. They feel they have the right and the 
responsibility under their 10th amendment to protect and police 
the safety of their residents, and they are doing that, and 
that is creating the kind of action that is protecting people 
in some States but not in all States.
    So we have a growing chorus urging Congress to strengthen 
the way we regulate chemicals and the way the American people 
are protected from those chemicals. We even hear businesses 
want that protection. So the women of this country are looking 
to you for your leadership. People in our military, our armed 
services, want assurances that their military bases will not be 
contaminated as Camp Lejeune was. People in polluted 
communities want to know that action will happen and that 
workers are safe. Parents want to know their 6-year-old 
daughters will not enter puberty and have a later lifetime risk 
of not only breast cancer but social, sexual issues, drug abuse 
as well as high-risk behavior. So our children and our 
grandchildren want to know that they won't face that burden.
    It is a burden then for Congress to take on the awesome 
responsibility of dealing with TSCA in an urgent manner with 
safety standards, the best available science, data on all 
chemicals, the ability to act on the worst, the right to know 
reasonably and responsively navigated and maintain the States' 
rights to protect citizens in the absence of federal action.
    Thank you very much.
    [The prepared statement of Ms. Rizzo follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT]
    
    Mr. Shimkus. Thank you.
    Mr. Auer, I am going to start with you and so I will give 
you that opportunity. Your testimony mentions that you consider 
the combination of ``unreasonable risk'' and ``the least 
burdensome requirement,'' which is what we are going to talk a 
lot about over the next couple months, in TSCA to be largely 
unworkable. From an intuitive standpoint, it makes a lot of 
sense to me that regulation should not be more than appropriate 
and necessary to address the risk. Do you agree?
    Mr. Auer. Yes.
    Mr. Shimkus. Is your concern with the wording suggesting 
extreme analysis?
    Mr. Auer. Yes. The least burdensome and the way that it has 
to be squared with the to extent necessary to protect against 
the risk standard, I believe makes it unworkable, or largely 
unworkable.
    Mr. Shimkus. Since you agree that it makes sense that 
regulation should not be more than is appropriate and necessary 
to address the risk, do you think there is a role for the basic 
concepts that underlie least burdensome to be included in 
future chemical legislation?
    Mr. Auer. Yes. The concept needs to be included per my 
previous response. We will need to take care with the wording 
to ensure that it does not become a straitjacket, however. 
Thank you.
    Mr. Shimkus. Ms. Bosley, the same to you. Do you think TSCA 
should have a least burdensome requirement for regulations?
    Ms. Bosley. Certainly. I think that that is helpful for 
small businesses, especially like mine, but it should be much 
more workable than it is today.
    Mr. Shimkus. How would you have it operate?
    Ms. Bosley. So right now, EPA has to discover all the 
avenues themselves and then decide between the least 
burdensome. That is a lot of analysis. I think if you opened it 
up to public comment and let the public and industry and NGOs, 
give them the options which are out there, then they can decide 
among those which are least burdensome.
    Mr. Shimkus. How easy is it to have a chemical's production 
stopped or curtailed in the early going?
    Ms. Bosley. Oh, it is much easier in the early going. If we 
are going to fail, we would rather fail early before too much 
investment has been spent. So we very much appreciate when EPA 
tells us before a chemical is in full production that they are 
going to regulate it.
    Mr. Shimkus. And how critical--and you mentioned this in 
your opening statement, but can you again talk about how 
critical it is to your business for the protection of 
confidential business information and what do you believe that 
the public should be entitled to?
    Ms. Bosley. Sure, sure. So especially for new chemicals and 
once again for small businesses like mine, our chemicals and 
our uses are very focused and so our competitors, mostly 
offshore competitors, know what we are doing, and if we are to 
put in a PMN, Premanufacture Notice, with chemical identity 
right out there, then they know what we are researching, which 
gives them a leg up on us. They are just a lower burden in 
other countries. So I think protection of CBI is very 
important. I know that it has been overused, though. I used to 
work for people who would check every box as CBI on a PMN, and 
that is much overused. I would be happy if there was upfront 
substantiation and re-substantiation maybe every 5 years but 
the initial protections are very, very, very important.
    Mr. Shimkus. And Mr. Gomez, when your testimony refers to 
characterizations about EPA's inability to meet its goal of 
ensuring the safety of chemicals, does this mean that chemicals 
are unsafe or that EPA is having an administrative problem 
prioritizing chemicals and reviewing them under the law?
    Mr. Gomez. So just to clarify, in our testimony we make 
characterizations about EPA's efforts to manage toxic chemicals 
consistent with the agencywide strategic goal of ensuring the 
safety of chemicals. We didn't evaluate whether chemicals were 
unsafe so we were looking again at the new approach that EPA 
has in place and the different things that they are doing and 
then we are drawing questions about whether they are going to 
realize the results that they have taken on.
    Mr. Shimkus. Thank you. Mr. Auer, the Government 
Accountability Office and Mr. Rosenberg have been critical of 
TSCA and EPA's implementation of it for almost 30 years from a 
quantitative standpoint. Do you believe that only looking at 
the program from this view is appropriate?
    Mr. Auer. I do believe you need to take a broader view. 
TSCA tools can be hard to implement and use in a regulation. 
There are many important voluntary efforts, the high-production 
volume challenge program, the PEFO, a stewardship program, use 
of SNURs to regulate PBTs, the flame retardant tris and other 
very well known chemicals. I do believe you need to take a 
broader view. On the new chemicals, you need to look at what 
EPA stops as well as the effect of EPA encouraging the industry 
to go in the direction of safer and greener chemicals.
    Mr. Shimkus. This is a great panel. Thank you very much. 
And now I will yield 5 minutes to the ranking member, Mr. 
Tonko, for 5 minutes.
    Mr. Tonko. Thank you, Mr. Chair.
    Mr. Gomez, you identified three main challenges for TSCA 
implementation in your testimony. First, the fact the Act does 
not require companies to generate or provide adequate 
information on chemical toxicity and exposure to EPA. Can you 
elaborate on what the obstacles are to getting that 
information?
    Mr. Gomez. Sure. So we noted that EPA has had difficulty 
obtaining adequate information on chemical toxicity, and the 
reason being that TSCA does not require that companies test 
chemicals before they are manufactured. TSCA requires EPA to 
demonstrate that chemicals pose certain risks before it can ask 
for such testing.
    Mr. Tonko. OK. And Ms. Rizzo, what are the public health 
impacts and specifically the impacts on cancer risks from the 
lack of information that you cited?
    Ms. Rizzo. Thank you. There have been several reports 
issued. The President's panel on cancer and the environment, 
the national conversation on chemicals and public health as 
well as a recent federal advisory committee on breast cancer 
and the environment, an interagency committee of 21 scientists, 
academics, agency people, that got together to look at this 
issue of the impact of chemicals and cancer, breast cancer in 
particular, not just looking at those that are named 
carcinogens but endocrine-disrupting chemicals. They really 
have an impact in utero, in early childhood, in puberty, during 
lactation to trigger cells to believe that they have been 
exposed hormonally and to react accordingly, increasing the 
risk of breast cancer. We see this in animal studies and we see 
it in the human manifestation of the increase in breast cancer 
and other hormonally related cancers.
    Mr. Tonko. Thank you. Mr. Gomez, the second challenge you 
identified is that even when EPA has obtained information about 
the risk from chemicals, the Agency has had difficulty banning 
or limiting the production or use of those chemicals. Can you 
explain why this happens to be the case?
    Mr. Gomez. Sure. So we have noted that EPA had difficulty 
proving that chemicals posed unreasonable risk and has 
regulated few chemicals under TSCA. EPA has a high legal 
threshold to meet so EPA must demonstrate unreasonable risk, 
which EPA tells us that they believe that it requires them to 
extensive cost-benefit analyses to ban or limit chemical 
production. And so as I noted, since 1976 only five existing 
chemicals have been controlled. We have previously recommended 
that Congress amend TSCA to reduce the evidentiary burden EPA 
must meet to control toxic substances and continue to believe 
that such changes are warranted.
    Mr. Tonko. Thank you. Mr. Rosenberg, what are some of the 
environmental and health impacts of this inability to ban or 
limit these chemicals?
    Mr. Rosenberg. Well, you are faced with ongoing exposure 
both in the health and the environment to all kinds of 
substances, particularly I mentioned PBTs, things that persist 
in the environment and bioaccumulate into our bodies, so those 
are, by definition, around for a long time, and as long as they 
are not controlled, more are produced, more are released into 
the environment, not just in the environment like out in the 
forest but in our homes and, you know, our workplaces and 
places we are. So if you are not controlling the exposure to 
the substances of concern and they are still being 
manufactured, even if they are not still being manufactured, 
they might still be in products. Once they are in there, they 
can get out of the products, whether during the natural life of 
the product, as it were, or during disposal or at other times.
    Mr. Tonko. Thank you. Ms. Rizzo, who bears the worst 
effects of these avoidable hazardous exposures?
    Ms. Rizzo. I am sorry, sir. I didn't hear that.
    Mr. Tonko. Who bears the worst effects of these avoidable 
hazardous exposures?
    Ms. Rizzo. Well, I think there are vulnerable--those that 
are most vulnerable amongst us. We see it for children, we see 
it for women, we see it for communities that are 
disproportionately affected because of where they live, what 
their legacy exposures are to these toxic chemicals. So you see 
people that live on toxic dump sites, essentially, you know, 
their build environment didn't consider their chemical 
exposure. You see it in poor people whose access to healthier 
foods, healthier products is just not there so they are going 
to get more exposure through whether it is personal care 
products they use or the air pollution, the freeway they live 
next to, the water that isn't as safe and as healthy. So I 
think if we look at breast cancer, there is a dramatic 
increased risk in premenopausal breast cancer amongst African 
American women, so the vulnerable populations need the greatest 
protection.
    Mr. Tonko. Thank you. I note, Mr. Chair, my time has 
expired so I will yield back.
    Mr. Murphy [presiding]. Thank you. I will now turn to the 
gentleman from Pennsylvania and chair of the Health 
Subcommittee, Mr. Pitts, for 5 minutes.
    Mr. Pitts. Thank you, Mr. Chairman.
    Ms. Roberts, some argue that TSCA does not encourage green 
chemistry. Does the TSCA structure discourage U.S. companies 
from innovating, including the creation of green chemistry?
    Ms. Roberts. Thank you for the question. No, I don't 
believe TSCA discourages development of green chemistry. In 
fact, I think as Ms. Bosley had mentioned in her testimony, 
given the way that Section 5 new chemical notification 
processes are set up, U.S. companies can develop new chemicals, 
have them reviewed by EPA and get them to market faster, and 
that ability to innovate in particular helps those companies 
that are trying to develop greener chemicals and get them on 
the market. So absolutely, I think that the way the TSCA 
framework is set up right now, it in fact is encouraging of 
innovation. I don't have the numbers in front of me but I do 
believe that there have been reviews showing that U.S. 
companies have higher patents on chemical products, on polymers 
and the like, again showing and proving that U.S. innovation is 
stronger than an other parts of the world.
    Mr. Pitts. We hear a lot of claims about chemicals not 
being tested, Ms. Roberts. Is there a requirement for new 
chemicals to have test data provided to EPA before they hit the 
market?
    Ms. Roberts. It is a very interesting question. Actually, 
there is not a requirement for new chemicals to be tested 
before they go on the market although, again, as Ms. Bosley 
mentioned, there is a requirement if data is available that it 
be submitted with the PMN. But EPA has developed a very useful 
and scientifically sound program where they have predictive 
models where they look at molecularly similar chemicals and 
they can make judgments on how an analog chemical would act so 
they can make some considerations of hazard exposures or hazard 
profiles. They can look at the information that is included in 
the PMN and determine how this particular material might be 
exposed to the general public or releases to the environment. 
EPA staff must be given great kudos because they have taken 
these models that they use internally and they have made them 
available to companies so that companies can use these models 
and determine whether there are going to be issues of concern 
with chemicals before they even send them to EPA for market, 
and again, I think that helps companies pursue those areas 
where they are going to be developing safer and greener 
chemicals.
    Mr. Pitts. Thank you. Mr. Auer, are many new chemicals 
safer and greener than their chemical predecessors?
    Mr. Auer. That is my personal opinion and experience. I was 
the chair of the Structure Activity Team in the new chemicals 
process for over a decade. I have seen thousands of new 
chemicals. I know what they are competing against. My personal 
view is yes. There has also been some EPA work showing that 
these structure activity predictions can work effectively. The 
chemicals are also more energy efficient, more product 
efficient. Oftentimes they substitute for known toxic 
chemicals. So as elaborated in an annex to my testimony, I 
believe that the New Chemicals Program has been very effective 
in encouraging the development and introduction of safer and 
greener new chemicals.
    Mr. Pitts. To follow up, the EU with more demanding 
requirements to market entry has seen dramatically fewer 
numbers of new chemicals introduced into commerce than the 
United States. Are these U.S. chemicals more risky than the EU 
chemicals?
    Mr. Auer. You know, my guess is they are pretty much the 
same chemicals. I am sure some are unique to the United States 
or the EU but my guess is, most are the same, and as elaborated 
in my annex, looking at the same period of time and the same 
rules, if you will, the EU with a base set saw 3,000 new 
chemicals introduced. The United States saw 17,000--maybe my 
numbers are wrong--six times as many over the same period in 
time. I believe that is a profound driver for innovation, given 
the safer and greener answer I gave previously.
    Mr. Pitts. Thank you. Mr. Gomez, some argue that companies 
overclaim confidential business information under TSCA. Is it 
EPA's responsibility to challenge claims that they think are 
not appropriate?
    Mr. Gomez. We believe so, but they have not done that.
    Mr. Pitts. Why hasn't EPA challenged companies on CBI 
claims?
    Mr. Gomez. That is a good question, sir. I would have to 
get to you if we have the answer but I don't know.
    Mr. Pitts. Ms. Bosley, Mr. Rosenberg's testimony suggests 
that chemicals under TSCA should be treated like pesticides, 
foods and drugs. Do you agree with this view, and why or why 
not?
    Ms. Bosley. I don't agree with that view. Pesticides are 
meant to be bioactive and to kill bugs. Foods and drugs are 
also meant to be consumed and thus real chemicals are not meant 
to be consumed. I think as part of the risk assessment for EPA, 
it would certainly look at the exposure pattern that industrial 
chemicals are having and they are able to collect data on that. 
They do that every 4 years now. So EPA knows what the exposure 
patterns are, and based on that exposure pattern, they can 
decide to look at a chemical more closely, something close to 
what FDA might do, but only when the exposure pattern makes it 
necessary.
    Mr. Pitts. My time is expired. Thank you, Mr. Chairman. I 
yield back.
    Mr. Murphy. The gentleman yields back and now I turn to the 
gentlelady from Colorado, Ms. DeGette, for 5 minutes.
    Ms. DeGette. Thank you very much, Mr. Chairman, and I think 
it is great that we are having this hearing on TSCA. I have 
been interested in this bill since I came to Congress in 1997, 
and I have probably said this before: TSCA was enacted over 30 
years ago and it is the only major environmental law in this 
country that has not been reauthorized. I think we can hear 
from the panel today there may be differences in nuance but 
pretty much everybody agrees, the industry as well as the 
environmental community, that TSCA really needs to be updated 
to keep pace with modern technology and to augment the EPA's 
resources and authority.
    Now, in the 111th Congress, two Congresses ago, this 
committee had significant hearings on TSCA, and one of the 
results of those hearings was legislation that created a 
process for the EPA to select and review high-priority 
chemicals against a minimum safety standard. We have other laws 
that have been effective at reducing risks related to 
pesticides, food and drugs but TSCA has not been effective at 
prioritizing action on chemicals that pose a high risk. So I 
want to ask some questions around these issues.
    The first thing I want to ask is, under Section 6 of the 
current law, if the EPA suspects exposure to chemicals puts 
people at a serious risk, something I have been looking at is, 
can the EPA take action in a timely manner, because, of course, 
there has only been six Section 6 actions. All of them took 3 
to 5 years. And in my opinion, none of us those were timely. 
Ms. Roberts, I am wondering what you think about that. Do you 
think that currently Section 6 of TSCA, if there is something 
that puts people at a serious risk, can that really operate to 
help the EPA make a decision in a timely way?
    Ms. Roberts. Thank you for the question. There is another 
section under TSCA, Section 7, which I didn't review, and I 
apologize, but it relates to imminent hazard. So if EPA were to 
find a situation where there was exposure and there was clear 
hazard, that they could take action under Section 7 and then 
proceed with the Section 6 rulemaking.
    Ms. DeGette. But that is if there is an imminent risk, but 
the next level down I am talking about is something that is a 
serious issue. Those are the ones that are taking 3 to 5 years. 
Do you think that that is adequate? Because that is a big gap 
between Section 7 and Section 6.
    Ms. Roberts. I would agree. I just wanted to point out that 
there was that option in Section 7, but I would also agree that 
a 3- to 5-year rulemaking is something that is absolutely 
burdensome. I am not sure that is a deficiency of TSCA, 
however.
    Ms. DeGette. OK. But if we could remedy it, certainly that 
would be preferable, correct?
    Ms. Roberts. I would agree.
    Ms. DeGette. Let us just go down right down the row.
    Mr. Auer. I would agree, it would be very difficult to 
regulate within 3 to 5 years, probably a few years longer 
because of the complexities of TSCA as well as the problems 
that you encounter in implementing a rulemaking proposal, 
consider comments, finalize.
    Ms. DeGette. Right.
    Mr. Gomez. Yes, we have noted in our report that that is a 
long time for EPA to do that, and it would take them, just for 
the 83 chemicals that they have chosen right now, over 10 years 
to go through them.
    Ms. DeGette. Right.
    Ms. Bosley. We favor a less burdensome rulemaking process 
for EPA as well.
    Ms. DeGette. Thank you.
    Mr. Rosenberg. It definitely takes too long for the Agency 
to be able to do almost anything, certainly under Section 6 
under TSCA, and the 3- to 5-year rulemaking in probably many 
instances is actually optimistic. The asbestos rule took 10 
years, I believe, and lately even other authorities under TSCA 
EPA has tried to use including their publishing a Chemicals of 
Concern list. They haven't even been able to formally propose a 
Chemicals of Concern list because that has been sitting at OMB 
for 3 years. So the hurdles EPA faces in taking any action go 
far even beyond the structure of the statute, which is pretty 
much what we are focused on today. There are bigger challenges 
even than that.
    Ms. DeGette. Thank you. Not but not least.
    Ms. Rizzo. Thank you. I would agree with that, and I would 
say the problem goes before we even get to having to make a 
rulemaking that we are not looking at the proof of safety first 
before we balance out the cost-benefit analysis or any other 
decision making. We should be looking at the safety of the 
chemical proven first with industry providing that information 
to the EPA so that we don't have to deal with this rulemaking 
lag.
    Ms. DeGette. Right. And I wanted to ask you, Ms. Rizzo, 
because in your testimony you talk about endocrine-disrupting 
compounds as a chemical of increased concern, and of course, it 
is not just pesticides that can alter genes. It can also be 
compounds as well. I am wondering of TSCA enables the EPA to 
test and evaluate the impacts of those compounds.
    Ms. Rizzo. Not adequately on human health and the 
environment, and I think that that is the real challenge of how 
we look at the classes of chemicals and what we do with them 
and how much time it takes, so no, we have not adequately 
evaluated EDCs for their impact on health.
    Ms. DeGette. Thank you. Finally, I want to take for a 
minute about the confidential business information. Mr. Murphy, 
although he is pretending he is the chairman right now, he is 
actually my chairman of the Oversight and Investigations 
Subcommittee, I am the ranking member on that, and we both know 
that good oversight requires open government and access to 
information, not just for the committee but for everybody, and 
I am cognizant about protecting confidential business 
information. I do it in other legislation that I am sponsoring. 
But if a government agency is going to manage an effective 
confidential business information claim program, it needs three 
processes: substantiation by the company seeking protection, 
Agency verification of CBI status, and opportunity for public 
challenge. And TSCA's CBI claims process is absent of that 
framework.
    So Mr. Gomez, I know that GAO has studied this issue 
extensively. Can you tell me what happens when there are 
overbroad CBI claims in terms of the EPA process and decision 
making? Very briefly, because I am almost out of time.
    Mr. Gomez. We have noted that EPA's ability to share data 
collected under TSCA is limited when you are dealing with 
confidential business information. Now, EPA has made some 
progress recently, so we just reported in our March 2013 
report, which I wanted to clarify from earlier, that EPA has 
expanded public access information. So since 2009, EPA has made 
617 formerly confidential chemical identities public because 
they have gone through a review process where they have looked 
at previous CBI claims and came to the conclusion that they 
could be released. EPA has also made 783 previously unavailable 
health and safety findings available to the public after 
reviewing approximately 15,000 such filings.
    Ms. DeGette. Thank you. Thank you, Mr. Chairman.
    Mr. Shimkus. The gentlelady yields back her time. The chair 
now recognizes the gentleman from Pennsylvania, Mr. Murphy, for 
5 minutes.
    Mr. Murphy. Thank you, Mr. Chairman.
    Ms. Roberts, first of all, can you just tell me what other 
federal environmental laws contain the regulatory reach of TSCA 
that allows regulation of manufacturing, processing, interstate 
and foreign commerce, use and disposal of chemicals and 
mixtures of chemicals and what are the law governing chemicals? 
Is TSCA the only one?
    Ms. Roberts. Absolutely not. TSCA--well, the chemical 
industry I think is probably one of the most regulated 
industries out there. In addition to TSCA, you have the Federal 
Insecticide, Fungicide, and Rodenticide Act, FIFRA. You have 
got regulations looking at food, drug, and cosmetics. There is 
the Clean Air Act, Clean Water Act, RCRA, Hazardous Materials 
Transport Act. There are numerous ones that are out there. I 
think the uniqueness of TSCA is recognizing that there are 
these other regulatory statutes that cover these particular 
special use or applications of companies and that TSCA is 
really to capture those that remain, the industrial chemicals, 
as I think Ms. Bosley appropriately pointed out.
    Mr. Murphy. As a sum total of all those, do TSCA and other 
bills prevent the EPA from evaluating chemicals of concern in 
any way that causes EPA to ignore or stops them from evaluating 
health risk?
    Ms. Roberts. No, sir, there is nothing in TSCA that would 
hinder EPA from going through that. I think what has been noted 
in the testimonies of most of us is, the fact that there is not 
a specified prioritization process for existing chemicals. 
There has been plenty of opportunity and programs where the 
Agency has started up such programs but for whatever reason 
they did not sustain momentum.
    Mr. Murphy. Mr. Auer, is pollution prevention or other 
steps that would have reduced emissions a component of judging 
this unreasonable risk?
    Mr. Auer. There is a Pollution Prevention Act, and as I 
interpret the meaning of ``unreasonable risk'' under TSCA, I 
interpret ``pollution prevention'' for substitutes, et cetera, 
et cetera all to be important components which go into that 
meaning of ``unreasonable risk,'' so, yes, pollution prevention 
is encompassed.
    Mr. Murphy. OK. Someone told me that water may not meet the 
standards of passing TSCA. Is that true?
    Mr. Auer. I think it is listed on the inventory. I don't 
know that we have assessed it.
    Mr. Murphy. I know in certain amounts if inhaled it can be 
lethal.
    Mr. Auer. Well, it can. There is water intoxication.
    Mr. Murphy. And I am not making light of that, but I do 
want to find out health effects, and I want us to focus on 
science, and that is critically important.
    Ms. Bosley, welcome here from western Pennsylvania. You 
mentioned that the cost and practicality of blanket testing 
requirements for chemicals would discourage new chemicals from 
coming to market. So generally speaking, how much would a well-
characterized study on a new chemical cost your company?
    Ms. Bosley. So if we were to do what is called a base set 
of testing as maybe is required in Europe, a single chemical 
could cost between a half a million and three-quarters of a 
million dollars, which is more than the profit my company makes 
in 5 years' time. So we certainly wouldn't--especially on a new 
chemical when we don't know the markets, so when we submit a 
PMN, we back up 90 days from when we think there will be 
commercial manufacture and usually more than that because we 
want to give ourselves time. We haven't fully assessed the 
market yet or the economics yet or even the final product form 
so we would never undertake that testing if it were to cost 
that much under such an unknown market analysis.
    Mr. Murphy. If you had to receive regulatory approval prior 
to developing and selling any of your products, similar to the 
REACH program that they have in the European Union, what would 
happen to your customers and your business?
    Ms. Bosley. They would be gone. They would go overseas 
where you don't need those sorts of protections before you 
enter into a market. I can say that because there is not 
testing when we first put in a PMN, it doesn't mean that we 
have stopped testing. EPA has another provision within TSCA 
called TSCA AD where when we do have new test data, we are 
required to submit it to EPA but only if it is adverse. So if 
we have predicted a certain toxicity and our chemical actually 
comes back less toxic than that, we have no provision to give 
that information to EPA.
    Mr. Murphy. So the EPA does not get that information?
    Ms. Bosley. They do not.
    Mr. Murphy. Do you take any steps at your location to deal 
with reducing any potential human hazards?
    Ms. Bosley. Oh, of course. We assess all the hazards that 
we can when we are first making a chemical. EPA does allow us 
to go into the lab and start making a chemical under an R&D 
exemption before we file that PMN. So we are able to assess a 
broad range of hazards before we are interested in entering to 
market, and every step we take, there is a risk assessment done 
within my own company, and we reduce the risk of that chemical 
exposure to humans and to the wastes that we generate. That is 
all part of our new chemical process.
    Mr. Murphy. Beyond that of what the EPA requires?
    Ms. Bosley. Oh, much beyond what EPA requires, yes.
    Mr. Murphy. Why?
    Ms. Bosley. It is good business sense. We are a small 
chemical company. We have limited resources. We don't want to 
spend our money getting rid of waste. We want to spend our 
money on new product development and innovation.
    Mr. Murphy. And taking care of your employees?
    Ms. Bosley. That is right.
    Mr. Murphy. Thank you. I yield back.
    Mr. Shimkus. The gentleman yields back his time. The chair 
now recognizes the gentlelady from California, Ms. Capps, for 5 
minutes.
    Mrs. Capps. Thank you, Mr. Chairman.
    It is so easy to focus on all the details of this statute 
and miss the big picture of why we are here, in my opinion. I 
would like to focus on one of the most important reasons for 
this law. Increasingly, researchers tell us that environmental 
exposures are a key factor in the onset of cancer. That means 
we need an effective Toxic Substance Control Act reform to 
fight cancer. According to the President's Cancer Panel in May 
of 2010, 41 percent of Americans will be diagnosed with cancer 
at some point in their lives, and about 21 percent will die 
from cancer. The panel also found that the true burden of 
environmentally induced cancer has been grossly underestimated 
and that the American people do not have sufficient information 
about harmful chemical exposures or how to prevent them.
    In February of this year, the interagency Breast Cancer and 
Environmental Research Coordinating Committee released a new 
report called ``Breast Cancer and the Environment: Prioritizing 
Prevention.'' We are fortunate to have with us here today a 
member of that committee who was involved in crafting that 
work. Ms. Rizzo, based on your work on that report, can you 
briefly describe the emotional, physical and financial burden 
of breast cancer? And that is a huge question to ask you in a 
very short time.
    Ms. Rizzo. Thank you. We talked about the fact that 3 
million women in this country are living having been diagnosed 
with breast cancer and 40,000 families will deal with death. 
Friends, families, when you think about the total number of 
people impacted by this disease in this country, it is 
overwhelming. The report did an analysis of the amount of money 
spent on the diagnosis and treatment of breast cancer, and that 
is about $17.5 billion a year. That doesn't relate all the 
additional costs--the human cost, the cost of childcare, the 
cost of getting to your treatments, the loss of work. So it is 
a tremendous burden on the country and a burden on the economy, 
a burden on the contribution of women to our world, to our 
social justice as mothers. We have lost mothers, lost school 
teachers. So the burden is quite dramatic, and the report 
addressed that pretty significantly. Thank you for asking.
    Mrs. Capps. What can we do as policymakers to lessen that 
that burden or to prevent this terrible disease altogether?
    Ms. Rizzo. What actions do we need to take?
    Mrs. Capps. What can we do as policymakers?
    Ms. Rizzo. As policymakers, to look at the exposures to 
chemicals that have evidence of harm and to navigate the 
science, weigh the evidence. If you are making a decision for 
or against an exposure, as for proof of safety rather than 
unreasonable risk of harm. I think we have the wrong paradigm, 
and it is demonstrated in the fact that there are so many 
people with chronic illnesses and that we are finding these 
toxic chemicals in our bodies.
    Mrs. Capps. So is there a role, and would you describe what 
it might be, the TSCA reform can play in preventing breast 
cancer?
    Ms. Rizzo. Absolutely. I think one of the key issues in 
TSCA reform is to look at the science. The National Academies 
of Science gave a report on how to look at doing the science, 
giving authority to the EPA to look at the science that isn't 
just good laboratory practices but to look at the academic 
science that could inform their decision making. So I think the 
safety standards have to be met on that. I think we also have 
to look at the way TSCA can look at the regulatory process, 
speeding it up, look at vulnerable populations. I think all of 
those contribute to the prevention of disease.
    Ms. Capps. For so many women, men, families, communities, 
the fight against breast cancer is a matter of life and death. 
We have it in our power to limit some of the environmental 
exposures that can cause this disease. I thank the chair for 
calling this hearing, and I hope it is the start of a serious 
effort to address the problems in TSCA and to better protect 
the American public. Thank you very much, and I will yield back 
the balance of my time.
    Mr. Harper [presiding]. The gentlelady yields back and I 
now recognize Mr. Johnson from Ohio for 5 minutes.
    Mr. Johnson. Thank you, Mr. Chairman, and I want to thank 
our panel members for being with us today.
    Mr. Auer, your testimony mentions that new chemical 
regulations can apply to more than one company. How frequent is 
this practice?
    Mr. Auer. Thank you for the question. It is quite frequent. 
There can be a toll manufacturer. There can be downstream 
companies that buy that chemical. When EPA negotiates a 5(a) 
order, a requirement can be to extend those requirements 
downstream. EPA also has Significant New Use Rule authority, 
which can apply those requirements to any other company that 
makes or processes that chemical.
    Mr. Johnson. OK. Some people have critically testified 
before this committee in the past about the regulatory and 
management outcomes under TSCA. Have the regulatory and 
management outcomes been as limited as some suggest?
    Mr. Auer. As I overelaborated in my statement as well as in 
my testimony, there are a lot of facts there. I am not arguing 
that enough has been done, but I think there has been a 
mischaracterization of the extent of the work. The fact that 
300 or more existing chemicals are regulated under SNURs, many 
of those are any-use SNURs. They are basically out of the 
market, as well as the other requirements. They are 
consequential and they need to be given due account.
    Mr. Johnson. OK. Does TSCA promote innovation, in your 
view?
    Mr. Auer. You know, I think the way TSCA struck the balance 
with new chemicals in taking the tough decision not to require 
testing and the costs associated with that has resulted in the 
United States leading the world in the innovation of new 
chemicals which, as I indicated before, I believe to be safer 
and greener. That is key.
    Mr. Johnson. All right. Ms. Bosley, you mentioned that the 
Existing Chemical Program faces challenges. How could EPA have 
such a performance disparity between new and existing chemical 
programs?
    Ms. Bosley. I think that all lies in the mandate from 
Congress. Frankly, the mandate and the time frames are very 
well laid out in TSCA for new chemicals but not so in existing 
chemicals. EPA has broad authority for existing chemicals to 
prioritize, to ban, to limit uses, but I think very few 
resources since there is no mandate.
    Mr. Johnson. Well, what are your views on a strategy that 
relies on tailored restrictions rather than outright bans?
    Ms. Bosley. Oh, I think restrictions are generally a better 
idea. So even in the asbestos case, let us just say, there are 
zero exposure but very critical uses of asbestos today in 
aerospace, space shuttle operations, some firefighting 
operations that a ban of asbestos would have eliminated and 
there was no clear alternative. So if you can demonstrate that 
there is a no-exposure use for even a very hazardous chemical, 
that use should be allowed to go on, so restrictions are much 
better than bans.
    Mr. Johnson. Well, thank you, Mr. Chairman. I yield back 
the remainder of my time.
    Mr. Shimkus. The gentleman yields back his time. The chair 
now recognizes the gentleman from California, Mr. McNerney, for 
5 minutes.
    Mr. McNerney. Thank you, Mr. Chairman. I thank the panel 
for testifying today.
    Mr. Rosenberg, I understand there are some 84,000 
synthesized chemicals used in the United States today. Is that 
about right?
    Mr. Rosenberg. There are roughly 84,000 chemicals on the 
TSCA inventory. They are not all in use at any one particular 
time, and the estimates are maybe that there is quite a bit 
fewer that are actually in use right now. We don't have as 
great a picture on that as we would under a better functioning 
TSCA. But any of those chemicals that are on the inventory can 
be used, manufactured or used at any given time. So if they are 
not in use now, they could be at some time in the future 
without additional review currently.
    Mr. McNerney. How many of those have been cleared for use 
of those 84,000?
    Mr. Rosenberg. Well, the 62,000 roughly were grandfathered 
in, so those made it, and I believe the bulk by volume of 
chemicals that are in use now are from that original 62,000. 
The 22,000 were reviewed. I think there is some discussion 
about the extent that they were reviewed but the 22,000 
chemicals have some amount of review.
    Mr. McNerney. So in your opinion, there are many chemicals 
that are being used even according to manufacturer's 
specifications finding their way into the environment and to 
human bodies?
    Mr. Rosenberg. Yes, absolutely that is the case, and the 
one piece of evidence for that is the CDC has done its biannual 
biomonitoring of people and has found--the more they look for, 
the more they find, but they have found hundreds of chemicals 
widely in people's bodies and their blood. So there is no 
question that even chemicals used as intended, whatever that 
might mean, are still winding up in people's blood or in their 
bodies and their tissues in ways that I assume weren't intended 
and are not good for people's health, presumably.
    Mr. McNerney. Ms. Rizzo, have you heard of the term 
``chemical trespass''?
    Ms. Rizzo. Yes, sir, I have.
    Mr. McNerney. Would you explain what that means, please?
    Ms. Rizzo. That is basically, I haven't given you 
permission to put that chemical in my body. It is trespassing 
into my body. That is how it is used. So I think when Mr. 
Rosenberg referred to biomonitoring, when you measure in blood, 
urine, cord milk, other body specimens, the presence of 
chemicals that you did not intend to have in your body that 
way, you didn't ask for it, you didn't give permission, that is 
what the trespass it.
    Mr. McNerney. Thank you. Mr. Rosenberg, do you share the 
view that the statutory changes are needed to protect human 
health and the environment from unsafe chemicals, or is the EPA 
going to be able to do this without statutory changes?
    Mr. Rosenberg. No, they won't be able to do it without 
statutory changes, and it is interesting, if you go back and 
look, GAO has been saying essentially that for 20 or 30 years. 
They wrote their first report on TSCA in 1980. They identified 
very much the same problems then that they are identifying now 
and it is really up to Congress to step up and take this effort 
seriously, and at this point the law is such a failure that, 
you know, a broader range of stakeholders is recognizing that 
it is causing problems--I talked about this a little bit in my 
testimony--as a result of this vacuum that is left by EPA's 
inability to take action, even when they have tried to. States 
are adopting all kinds of different use restrictions and other 
bans and activities, and the marketplace is also taking action. 
I don't think any of that is a bad thing but it is a sign that 
TSCA is really not working. I mean, there is some preemption 
authority under TSCA but it has never been exercised as far as 
I know because they have never been able to accomplish anything 
that would even hint at preemption. So it is a nonfunctioning 
law to a great extent, not a total extent but a large extent.
    Mr. McNerney. Well, is bureaucratic delay in clearing 
chemicals part of the problem in protecting our safety? Does 
anyone want to answer that on the panel?
    Mr. Auer. The New Chemicals Program takes 90 percent of its 
decisions within 90 days. The remaining chemicals, there can 
sometimes be a bit of delay but, you know, within months or 
sometimes longer everything is decided.
    Mr. Rosenberg. It would be absolutely critical for Congress 
to seriously look at streamlining EPA's ability to do different 
things including getting data from companies and taking 
actions, both regulatory action and assessment actions, and 
there is, in addition to whatever hurdles EPA faces, one hurdle 
is that they are underresourced significantly and particularly 
in this program, so that is a problem, and then I mentioned 
this earlier, OMB has been sort of roadblock for even things 
that EPA has tried to do, particularly in the last few years, 
with their existing authority. They have taken a number of 
steps to try to get more information out to the public and 
assess chemicals, and every step of the way they have been 
bogged down by OMB, and that a whole other major problem.
    Mr. McNerney. Thank you, panel members, and thank you, Mr. 
Chairman.
    Mr. Shimkus. The gentleman's time is expired. The chair now 
recognizes the gentleman from Mississippi, Mr. Harper, for 5 
minutes.
    Mr. Harper. Thank you, Mr. Chairman, and thank each of you 
for being here and giving us your insight. We have many things 
we need to look at as we go back and review this and see where 
we are, and I would like to start with Ms. Roberts, if I could.
    Thank you for your earlier presentation. I tried to squint 
as best I could to read the slide and follow that, but thank 
you for your time on that. Can you tell me what the practical 
difference is between the authority in Sections 4 and 8 to 
develop information?
    Ms. Roberts. Sure. My apologies for the small print on the 
slides, but I did want to try to fit everything into one slide 
so that people could sort of reference it back. So under 
Section 4, EPA has the authority to require testing, and I am 
trying to find the exact wording, but if there is concern of an 
unreasonable risk for a chemical, that is one finding that EPA 
can make to issue a test rule, or if the chemical is produced 
or released into the environment in substantial quantities, 
that is the second finding that EPA would have to make in order 
to issue a test rule. It seems to me that the Section 8 
provisions that currently exist give EPA that opportunity to 
collect that information. Section 8(e) requires companies to 
immediately inform EPA if there is a substantial risk on a 
chemical. Section 8(c) requires companies to provide EPA upon 
request information that they gather from their companies. So I 
think that would make that first finding the significant risk. 
The second finding of production volumes are already collected 
under the chemical data reporting, which occurs every 4 years, 
or under Section 8(a) should EPA decide they want to gather 
that information.
    Mr. Harper. OK. Can EPA gather enough information under 
Section 8 to justify a test rule under Section 4?
    Ms. Roberts. It is my belief that they could, yes, sir.
    Mr. Harper. Now, I know Mr. Rosenberg had argued that CBI 
should be protected less and re-substantiation required for 
these claims. What are the issues that come with it?
    Ms. Roberts. I think we need to recognize that TSCA covers 
a huge gamut of different industries and different businesses, 
and so while the idea of re-substantiation on a certain 
periodic time may make sense for some companies, it may not for 
all. So for certain companies, for example, Coca-Cola comes to 
mind. They are not going to share their formulation ever. So if 
they had to re-substantiate that every year, and I realize it 
is not covered under TSCA but it is the first example that came 
to mind, that would be very problematic for them. And again, 
keep in mind the type of information that is required under 
TSCA under New Chemical Notification. You have to tell the EPA 
what the byproducts are, what the impurities are. That could be 
very meaningful information for a competitor because now they 
know what you are using to manufacture that. Volumes produced, 
again, could be very meaningful to a competitor to get a better 
understanding of what your market share is so that they may be 
able to glean into it. So again, CBI is extraordinarily 
important and really should not be taken lightly.
    Mr. Harper. Thank you for that.
    Ms. Roberts. My pleasure.
    Mr. Harper. Mr. Gomez, if I may ask you, the Acting 
Administrator of EPA's Chemical Office told you that the law 
makes it impossible for EPA to assess and regulate chemicals. 
How will EPA use its requested $67 million for this office in 
fiscal year 2013?
    Mr. Gomez. That is a very big question, and a good 
question, and that is something that we will have to get back 
to you on since EPA is not here, who could probably better 
answer it. But EPA, one thing that I do want to mention though, 
EPA has this new approach that I talked about in my statement, 
and so in this new approach, they are doing new things using 
the existing TSCA authority. So one of the things that we 
talked about earlier already is they are extending those 
Significant New Rule uses where they have added a lot more 
chemicals that they are looking at, so they are trying 
different things to try and get more information. We noted that 
basically it is too early to tell whether that is going to be 
achievable or not, especially since in their strategy they 
haven't laid out some key elements that we think are needed for 
them to succeed.
    Mr. Harper. Do you agree with that assessment, that the 
resources are not there, that $67 million is not sufficient to 
do this?
    Mr. Gomez. Sure. That is what the Agency has told us also 
that it is a reason because of resources but it is not 
something that we have looked at specifically to see if they 
have the resources.
    Mr. Harper. And you will have to give me a quick answer on 
this, but your testimony mentions the EPA creation of a 
Chemicals of Concern list under Section 5(b)(4) and the delay 
of this list at OMB. Could you please explain in very short 
order for me the specific understanding of and maybe the 
criteria for the ``may present'' clause which either gets a 
chemical on or off the list?
    Mr. Gomez. Well, very briefly, that is something I will 
have to get back to you on, but that list is still at OMB. It 
has been there for a while. So----
    Mr. Harper. I would appreciate it if you could give me a 
detailed answer to that.
    Mr. Gomez. We will do that.
    Mr. Harper. Thank you very much. I yield back my time.
    Mr. Shimkus. The gentleman yields back. The chair now 
recognizes the gentleman from Texas, Mr. Green, for 5 minutes.
    Mr. Green. Thank you, Mr. Chairman. I appreciate your 
holding this timely hearing on the Toxic Substance Control Act. 
Over the years--and again, some of you may not know I represent 
a district that is heavy petrochemical, the biggest 
petrochemical complex in the country, second in the world. 
There is nearly universal consensus among all stakeholders that 
we need to have TSCA reform, and it is necessary to provide 
greater regulatory certainty for the industry while giving EPA 
the necessary authority to protect human health and the 
environment from hazardous chemicals, and I know the Senate 
just before the death of Senator Lautenberg, he and Senator 
Vitter had introduced legislation that had been put together as 
a compromise. We have had TSCA reform legislation in the House 
and Senate for it seems like my whole career here, and it has 
never gotten anywhere. So maybe we need to see what we can do 
to bring the parties together which the Senate has been doing 
and work across the aisle.
    My first question is for the whole panel. In 2008, I 
introduced a bill that would have banned the import, 
manufacture and distribution of asbestos in response to a 1991 
court hearing that the EPA's attempted ban of the substance did 
not follow the least burdensome requirement clause under TSCA. 
My question for everybody on the panel: If the least burdensome 
requirement were removed from TSCA, would EPA have a strong 
authority to protect human health and environment and be able 
to uphold future bans on known dangerous substances like 
asbestos before a court trial? If you could do yes or no, 
obviously we have a big panel. In fact, we have more panel than 
we do members.
    Ms. Roberts. Although I am not a lawyer, I think I am going 
to say it depends. I think I would be concerned if there was 
not a least burdensome aspect in the regulation simply because 
banning an entire chemical versus picking certain applications 
that are high risk could be problematic, and so I think there 
is some good reason for least burdensome, and I leave that as 
my answer.
    Mr. Auer. I think the ``the'' in ``the least burdensome'' 
is a big part of the problem. I do think that those concepts 
are important and need to be accommodated in any such 
determination.
    Mr. Green. Mr. Gomez?
    Mr. Gomez. Sure. That is something that really is a policy 
call, I believe. I mean, GAO has gone on record to say that it 
is a high legal threshold for EPA to meet and has had 
difficulty meeting that, and if that is changed, whether or not 
that results in different outcomes.
    Mr. Green. Anyone else on the panel?
    Ms. Bosley. I agree with Charlie that ``the least 
burdensome'' is probably too high a threshold but ``least 
burdensome'' should be in the mix there as far as the risk-
making decision.
    Mr. Rosenberg. ``Least burdensome'' is definitely a 
problem, and EPA would be better able to regulate without it. 
TSCA contains a bunch of options that EPA has to use, and there 
is no reason that they should or would always go to the maximum 
option that they have but in certain instances that is the most 
health protective, and since the statute is intended to be 
health protective, that should have priority.
    Ms. Rizzo. Yes, I would just add that the burdensome part 
is also the burden on public health that should be weighed 
evenly with the burden on business in making that decision.
    Mr. Green. OK. Ms. Roberts, in your testimony you state 
that the EPA has been constrained when using its rulemaking 
authorities. Why is that, and what are the ramifications of 
that constraint?
    Ms. Roberts. In my view, the reason that they are 
constrained is because rulemakings in general take a long time. 
There is a lot of administrative procedures that are required 
under rulemakings so that, I believe, is the problem. The 
ramifications are that they can't gather information in a 
timely manner and therefore can't make decisions as far as risk 
management or the needs for testing.
    Mr. Green. Also in your testimony, you note that EPA could 
implement a prioritization process which specifies timelines 
for Existing Chemical Review. Could you elaborate on the 
benefits of a prioritization process and how it would improve 
TSCA?
    Ms. Roberts. Sure. Again, because under the New Chemical 
Review there is a certain statutory deadline that is associated 
with that, if there were a specific deadline or at least for a 
prioritization of existing chemicals that EPA will go through 
during a review, I think that would keep EPA sort of on the 
straight and narrow. They would get some work accomplished. As 
I had said before, there are programs that have started and 
stopped. I think what we need is to maintain momentum under one 
particular prioritization program.
    Mr. Green. Mr. Chairman, in my last 14 seconds, I guess, 
Mr. Gomez, and you might have to get back with me on this. In 
your testimony, you note that EPA has difficulty in obtaining 
adequate information on chemical toxicity and exposure. Has GAO 
provided recommendations to EPA on how to improve information 
gathering so that the status of EPA's actions on these 
recommendations, and also in your professional opinion, does 
EPA have sufficient resources--staff, funds--to effectively run 
TSCA?
    Mr. Gomez. Certainly. We have noted and have commented on 
the first part of your question and talked about the SNURs that 
we mentioned earlier, that that is the way that EPA is getting 
additional information now. The second part of the question we 
will have to get back to you on.
    Mr. Green. Thank you. Thank you, Mr. Chairman.
    Mr. Shimkus. The gentleman's time is expired. The chair now 
recognizes the gentleman from Louisiana, Mr. Cassidy, for 5 
minutes.
    Mr. Cassidy. Thank you all.
    Mr. Rosenberg, just a couple things. You listed the 
statistics for cancer, how prevalent it is in our society, but 
you did not mean to suggest those are all due to chemical 
exposure, I presume?
    Mr. Rosenberg. That is correct.
    Mr. Cassidy. I will just say, your testimony kind of gave 
way to that. Secondly, let me ask you, you are not also 
suggesting that when you say that even minimal exposure can 
cause cancer that there isn't a threshold effect? Anyone who 
has ever had a hangover has had formaldehyde in their body, and 
yet--formaldehyde as a metabolite of alcohol--but yet it is not 
known to cause cancer in that low level or probably half the 
room wouldn't be here. And so again, you are not suggesting 
there is not a threshold effect, which is a fairly well 
documented scientific concept.
    Mr. Rosenberg. Yes. The most recent National Academy of 
Sciences studies actually recommend EPA's methodology for 
assessing chemicals not to assume a threshold. They 
traditionally have not assumed a threshold but----
    Mr. Cassidy. They haven't, but the Native American of 
Sciences criticized the EPA for not doing so in their 
methodology on their formaldehyde sort of regulation. As a 
doctor, I will acknowledge that aflatoxin is something we are 
all exposed to. It is well known as a carcinogen for liver 
cancer but it is only over a certain threshold that risk poses 
itself, not the amount that we get opening up a little bit of 
an old jar of peanut butter. If you will send that to me, I 
would like to see where they deny that there is not that 
threshold effect.
    Mr. Rosenberg. Absolutely. I would be happy to send that to 
you.
    Mr. Cassidy. Ms. Rizzo, it turns out my wife is a breast 
cancer surgeon, and so we were on vacation recently, and you 
may think we don't have a life, but we were actually looking up 
the literature on chemical exposure and breast cancer, so it 
just so happens and serendipitously----
    Ms. Rizzo. On your vacation, sir?
    Mr. Cassidy. What is that?
    Ms. Rizzo. Was that on your vacation?
    Mr. Cassidy. It was on our vacation, believe it or not. 
Again, get a life, huh?
    Now, I was struck, though, when I looked at the literature 
that really if you look at the top nine things that are 
associated with breast cancer, chemicals are not on that top 
nine or top eight or top seven, and when they speak--unless you 
include estrogen or hormonal therapy, and then they attribute 
that overwhelmingly to the metabolic syndrome with high rates 
of obesity and low rates of physical activity. While we were 
speaking, I loaded the document that you have in reference 3, 
the recent IB whatever, and they again emphasize the role of 
obesity and the metabolic syndrome, absence of physical 
activity, but don't give the prominence to chemicals except 
insofar that rat mammary tissue is affected but they admit that 
it is unclear how well that would translate to human studies. 
Any comments on that? Because from your data, from your 
presentation, I get a sense that chemicals are the etiology, 
and my wife has just told me you have to reassure women as to 
what--rightly reassure them as to what the real risk is because 
they can modify cigarettes and alcohol and weight and physical 
activity. If you add the existential concern of chemicals, 
which is very unproven as to their role, then that makes it 
harder for the physician to provide that reassurance. What are 
your thoughts on that?
    Ms. Rizzo. Well, we are sympathetic with the uncertainty 
and with the difficulty that it provides. If you look at all of 
the known risk factors, you can account for maybe half of 
breast cancer. I will give you an example that might be working 
looking at----
    Mr. Cassidy. Well, no, not if you include estrogen because 
obviously women--my wife always says, and believe me, if I 
could channel my wife here, I would be a much better man. My 
wife would say that the primary risk factor for breast cancer 
is being a woman, and she would then say that it clearly is 
related to hormones because it happens after menarche, and that 
the earlier the menarche, i.e., the longer the exposure to 
estrogen, the higher the risk, and then you go into cigarette 
smoking and alcohol. Now, we do know the risk factor, and it is 
estrogen exposure.
    Ms. Rizzo. Well, it is also estrogen-mimicking exposure, 
and that is where the toxic chemicals come in.
    Mr. Cassidy. Now, that literature, though, is very thin. I 
have looked at it, and it is principally among rat mammary 
tissue, and it is unclear from the scientists, and that article 
that you referenced points this out, that it is unclear how 
well you can translate rate data to human data. Do you dispute 
that?
    Ms. Rizzo. I don't think that was the conclusion of the 
report. The animal-to-human paradigm was an essential factor in 
this issue. The hormonal factor, the chemical exposure factor--
I will give you another example.
    Mr. Cassidy. Those are two different issues, though. The 
hormonal factor again is related to physical activity and 
obesity. The more physical activity, the less obesity, and the 
more obesity, the earlier the age of menarche, that is so well 
established, and my wife is always preaching that gospel, so 
that is why I want to make sure that we acknowledge what we 
know to be the strongest risk factors and also acknowledge that 
the role of chemicals is really not as well defined.
    Ms. Rizzo. Which part of that would you like me to 
challenge back?
    Mr. Cassidy. The very last one, because all the studies I 
have read were all on rat data, so unless the rat data is----
    Ms. Rizzo. No, there is also human data. We are in the 
middle of a human experiment, and I will give you a couple 
examples of that. Camp Lejeune, the military base, where these 
military men were exposed to solvents in the water. We have 
over 100 cases now of male breast cancer as a result of that 
exposure to that toxic chemical. Male breast cancer is not an 
ordinary occurrence. You wouldn't expect a cluster of it. Very 
highly associated to a chemical exposure. So that is one factor 
that I wanted to point out.
    Mr. Cassidy. I have read about this 3 years ago so I am a 
little rusty but the Army takes some issue with that 
epidemiology, as I recall. I am not saying you are wrong. I am 
just saying that before we accept it as totally unchallenged, I 
think I remember that the Army does challenge that. Is that 
fair? Oh, I am sorry, the Marines. I don't want to offend 
anybody.
    Ms. Rizzo. No, it was Marines. The ATSDR is looking into 
that at the CDC, and I am more than happy to follow up with 
some additional information on that. And the second part has to 
do with the BRCA gene and----
    Mr. Cassidy. That is purely genetic.
    Ms. Rizzo. Yes, that is genetic, but there is a four- or 
five-fold increased risk of breast cancer in women with the 
BRCA gene than there was back in the 1940s.
    Mr. Cassidy. But then also if you look at the mean body 
weight of women from now relative to the 1940s, the mean body 
weight is significantly higher than it formerly was, again 
supporting the fact that obesity and the estrogens produced by 
adipose tissue, or fat tissue, is a stronger risk factor as 
your paper promotes.
    Ms. Rizzo. I would also look at obesogens, sir, and I am 
happy to send you some on the chemicals that act as obesogens 
that are contributing to early childhood obesity and early 
puberty.
    Mr. Shimkus. The gentleman's time is far expired. I have 
enjoyed the questioning. Now the chair recognizes the ranking 
member of the full committee, Mr. Waxman, for 5 minutes.
    Mr. Waxman. Thank you, Mr. Chairman. I want to continue to 
pursue that issue because there are a lot of different causes 
for disease and we can isolate some but we can't know all the 
factors that are happening.
    Every day American people come in contact with a wide range 
of chemicals in their food packaging, in their furniture, in 
their workplace. They believe these chemicals have been found 
to be safe, that they have been tested, but this is a mistaken 
impression. In many cases, chemicals simply aren't tested, and 
in some cases, even chemicals that we know pose substantial 
risk remain in the products that we use every day. As cancer 
rates and the rates of other serious health issues arise, we 
have an obligation to do more.
    So Ms. Rizzo, what are some of the carcinogenic chemicals 
that have been linked to breast cancer or to mammary tumors in 
animal studies?
    Ms. Rizzo. Well, I think you can look at some of the--you 
know, we have benzene, we have the solvents, we have some of 
those chemicals, organochlorines, the persistent 
bioaccumulative chemicals. Then we have those chemicals that 
disrupt the endocrine system that we were speaking about 
earlier that are provocative, that act like estrogen, that 
trick your body into believing you have been exposed to 
estrogen, which we know a woman's lifetime exposure to estrogen 
increases her risk. So if your body is exposed to chemicals 
that act like estrogen, they provoke in the same way. We saw 
that with hormone replacement therapy. I don't think anybody 
can forget years ago when the Women's Health Initiative study 
came out, and millions of women stopped taking hormone 
replacement therapy, which was increasing risk between 26 and 
40 percent, and we saw a drop in breast cancer incidence at 
that point because women exposed to that hormone for 4 years or 
more had a dramatic increased risk. So we know that hormonally 
active chemicals, biologically active chemicals are connected 
to breast cancer.
    Mr. Waxman. Are those the same as carcinogens?
    Ms. Rizzo. They are not categorized as carcinogens. They 
provoke in a different way. They can set is up for other 
exposures that provoke rapid cell C invoice or interfere with 
periods of time when our cells are in rapid cell development.
    Mr. Waxman. Have adequate restrictions been imposed on 
these chemicals that you are discussing to prevent human 
exposure to the extent possible?
    Ms. Rizzo. I would say no, they are not.
    Mr. Waxman. What are some of the ongoing uses of those 
chemicals that might lead to dangerous exposures?
    Ms. Rizzo. Those chemicals, I will give you--there are 
chemicals in our food can linings. There are chemicals in 
personal care products. They are not all under the control and 
auspices of the Environmental Protection Agency. But that which 
EPA and TSCA does to assess risk, to look at chemicals has an 
influence across the broad spectrum of uses. So if we don't 
test chemicals that we are exposed to in a real way every day 
in real time, in mixtures, in accumulation and over time, then 
we will never fully understand, as was raised, what their 
contribution is but we know that if in cell studies they are 
making cells turn into cancer, if they are giving mammary 
tumors in animals, then we should expect a similar impact on 
humans. We do that to test pharmaceuticals. We like animal 
testing when we are trying to approve a pharmaceutical for 
clinical trial. We don't like it so much when it tells us the 
chemical may harm us.
    Mr. Waxman. My colleague was talking about other factors--
obesity, cigarette smoking. I would assume that gene that would 
make a woman more susceptible or more likely to have breast 
cancer would be another factor. If those factors are serious 
factors, does that negate the impact of these chemicals?
    Ms. Rizzo. Not at all, and 5 to 10 percent of breast cancer 
is associated with the breast cancer gene. Smoking is a 
chemical, so let us not forget, tobacco smoke and secondhand 
smoke are chemicals. When you look at the obesity and you look 
at the contributing factors to obesity and you look at some of 
the chemicals in food packaging and in food, then we have to 
ask the question, what are the other exposures that are 
contributing to that. It is not simply a matter of eating too 
much.
    Mr. Waxman. Let me ask you about these endocrine disruptors 
because you seemed to single them out as the most serious. Have 
those chemicals been adequately restricted or banned, and what 
are some of their ongoing uses to which we might be exposed?
    Ms. Rizzo. Endocrine disruptors have not been, and I think 
there is an effort--the endocrine disruption panel that should 
be working on this is, I don't know, 10 years behind time, I 
think. We can certainly get more information for the committee. 
I don't want to mistake that time frame. But that is not an 
insignificant effort that needs to be made to look at the 
impact of endocrine-disrupting chemicals, and we are not 
talking just about breast cancer. We are talking about 
testicular cancer, prostate cancer. These are hormonally 
responsive cancers, and it is demonstrated in cell and animal 
studies. So I think it is very important that we look at those, 
that we study them adequately and that where we don't need 
them, we shouldn't be using them when they are non-essential. 
There are things that we essentially need but we don't need to 
have some of those chemical exposures, and I think it will spur 
innovation if we say we are concerned about them, come up with 
an alternative to bisphenol-A or to phthalates or to some of 
the others. And I am sure our American industry can do it. We 
are smart. I am confident in them.
    Mr. Waxman. Thank you, Mr. Chairman.
    Mr. Shimkus. The chair thanks the ranking member. The chair 
wishes to thank you all for a really productive and educational 
hearing. I want to advise you that you will be receiving 
written questions as were posed, and your answers will be 
included for the record. I want to advise members that there 
will be five legislative days for members to submit opening 
statements for the record. Finally, with all the interest in 
this subject, we are going to leave the record open to receive 
helpful comments on this subject. Without objection, so 
ordered.
    The hearing is now adjourned.
    [Whereupon, at 12:14 p.m., the subcommittee was adjourned.]
    [Material submitted for inclusion in the record follows:]
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