[House Hearing, 113 Congress]
[From the U.S. Government Publishing Office]
REGULATION OF NEW CHEMICALS, PROTECTION OF CONFIDENTIAL BUSINESS
INFORMATION, AND INNOVATION
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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
__________
JULY 11, 2013
__________
Serial No. 113-68
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
FRED UPTON, Michigan
Chairman
RALPH M. HALL, Texas HENRY A. WAXMAN, California
JOE BARTON, Texas Ranking Member
Chairman Emeritus JOHN D. DINGELL, Michigan
ED WHITFIELD, Kentucky Chairman Emeritus
JOHN SHIMKUS, Illinois EDWARD J. MARKEY, Massachusetts
JOSEPH R. PITTS, Pennsylvania FRANK PALLONE, Jr., New Jersey
GREG WALDEN, Oregon BOBBY L. RUSH, Illinois
LEE TERRY, Nebraska ANNA G. ESHOO, California
MIKE ROGERS, Michigan ELIOT L. ENGEL, New York
TIM MURPHY, Pennsylvania GENE GREEN, Texas
MICHAEL C. BURGESS, Texas DIANA DeGETTE, Colorado
MARSHA BLACKBURN, Tennessee LOIS CAPPS, California
Vice Chairman MICHAEL F. DOYLE, Pennsylvania
PHIL GINGREY, Georgia JANICE D. SCHAKOWSKY, Illinois
STEVE SCALISE, Louisiana JIM MATHESON, Utah
ROBERT E. LATTA, Ohio G.K. BUTTERFIELD, North Carolina
CATHY McMORRIS RODGERS, Washington JOHN BARROW, Georgia
GREGG HARPER, Mississippi DORIS O. MATSUI, California
LEONARD LANCE, New Jersey DONNA M. CHRISTENSEN, Virgin
BILL CASSIDY, Louisiana Islands
BRETT GUTHRIE, Kentucky KATHY CASTOR, Florida
PETE OLSON, Texas JOHN P. SARBANES, Maryland
DAVID B. McKINLEY, West Virginia JERRY McNERNEY, California
CORY GARDNER, Colorado BRUCE L. BRALEY, Iowa
MIKE POMPEO, Kansas PETER WELCH, Vermont
ADAM KINZINGER, Illinois BEN RAY LUJAN, New Mexico
H. MORGAN GRIFFITH, Virginia PAUL TONKO, New York
GUS M. BILIRAKIS, Florida
BILL JOHNSON, Missouri
BILLY LONG, Missouri
RENEE L. ELLMERS, North Carolina
Subcommittee on Environment and the Economy
JOHN SHIMKUS, Illinois
Chairman
PHIL GINGREY, Georgia PAUL TONKO, New York
Vice Chairman Ranking Member
RALPH M. HALL, Texas FRANK PALLONE, Jr., New Jersey
ED WHITFIELD, Kentucky GENE GREEN, Texas
JOSEPH R. PITTS, Pennsylvania DIANA DeGETTE, Colorado
TIM MURPHY, Pennsylvania LOIS CAPPS, California
ROBERT E. LATTA, Ohio JERRY McNERNEY, California
GREGG HARPER, Mississippi JOHN D. DINGELL, Michigan
BILL CASSIDY, Louisiana JANICE D. SCHAKOWSKY, Illinois
DAVID B. McKINLEY, West Virginia JOHN BARROW, Georgia
GUS M. BILIRAKIS, Florida DORIS O. MATSUI, California
BILL JOHNSON, Missouri HENRY A. WAXMAN, California, ex
JOE BARTON, Texas officio
FRED UPTON, Michigan, ex officio
C O N T E N T S
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Page
Hon. Phil Gingrey, a Representative in Congress from the State of
Georgia, opening statement..................................... 1
Prepared statement........................................... 3
Hon. Paul Tonko, a Representative in Congress from the State of
New York, opening statement.................................... 4
Hon. Fred Upton, a Representative in Congress from the State of
Michigan, prepared statement................................... 104
Hon. Henry A. Waxman, a Representative in Congress from the State
of California, prepared statement.............................. 105
Witnesses
Craig Morrison, CEO of Momentive Performance Materials Holding,
LLC, and Chairman of The Executive Committee, American
Chemistry Council.............................................. 5
Prepared statement........................................... 8
Answers to submitted questions............................... 134
Len Sauers, Vice President, Global Sustainability, Procter and
Gamble......................................................... 24
Prepared statement........................................... 26
Answers to submitted questions............................... 154
David Isaacs, Vice President, Government Affairs, Semiconductor
Industry Association........................................... 36
Prepared statement........................................... 162
Answers to submitted questions............................... 166
Rainer Lohmann, Professor of Oceanography, University of Rhode
Island......................................................... 49
Prepared statement........................................... 51
Answers to submitted questions............................... 171
Heather White, Executive Director, Environmental Working Group... 65
Prepared statement........................................... 67
Answers to submitted questions............................... 175
Submitted Material
Letter of July 11, 2013, from The Center for International
Environmental Law to the subcommittee, submitted by Mr. Waxman. 107
Letter of July 9, 2013, from 3M to the subcommittee, submitted by
Mr. Gingrey.................................................... 112
Letter of July 11, 2013, from the American Cleaning Institute to
the subcommittee, submitted by Mr. Gingrey..................... 116
Statement of CSPA, submitted by Mr. Gingrey...................... 118
Letter of July 10, 2013, from the Department of Toxic Substances
Control to the subcommittee, submitted by Mr. Waxman........... 125
Executive summary entitled, ``Driving Innovation,'' submitted by
Mr. Waxman..................................................... 130
REGULATION OF NEW CHEMICALS, PROTECTION OF CONFIDENTIAL BUSINESS
INFORMATION, AND INNOVATION
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THURSDAY, JULY 11, 2013
House of Representatives,
Subcommittee on Environment and the Economy,
Committee on Energy and Commerce
Washington, DC.
The Subcommittee met, pursuant to call, at 9:43 a.m., in
Room 2322 of the Rayburn House Office Building, Hon. Phil
Gingrey [Vice Chairman of the Subcommittee] presiding.
Members present: Representatives Gingrey, Murphy, Latta,
Cassidy, Johnson, Tonko, Green, McNerney, Barrow, and Waxman
(ex officio).
Staff present: Nick Abraham, Legislative Clerk; Charlotte
Baker, Press Secretary; Sean Bonyun, Communications Director;
Jerry Couri, Senior Environmental Policy Advisor; David
McCarthy, Chief Counsel, Environment and the Economy; Andrew
Powaleny, Press Secretary; Jacqueline Cohen, Democratic Senior
Counsel; Greg Dotson, Democratic Staff Director, Energy and
Environment; and Caitlin Haberman, Democratic Policy Analyst.
OPENING STATEMENT OF HON. PHIL GINGREY, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF GEORGIA
Mr. Gingrey. The committee will come to order. The chair
recognizes himself for 5 minutes for an opening statement.
Last month, the subcommittee held a hearing on the history
and the impact of Title 1 of the Toxic Substance Control Act,
better known as TSCA. The June 13 hearing was a good start to
understanding a law as complex as it is broad. Today, we take a
deeper dive and focus on new chemical regulation protection of
sensitive businesses' information, and their effect on
innovation. I believe evaluating TSCA Sections 5, New
Chemicals, and 14, Disclosure of Data, is fundamental to
judging progress in new technologies and manufacturing
frontiers in our country.
Testimony in our June 13 hearing supports this notion.
American companies are on the cutting edge of chemical
innovation, and the new chemical structure in TSCA has allowed
us to lead the world. For example, the European Union's new
chemical requirements saw 3,000 new chemicals introduced, while
the United States saw six times as many new chemicals
introduced over that same period of time. One out of six of the
chemicals currently used in commerce did not exist in 1979.
TSCA Section 5 does not merely set out the notification
requirements for these chemicals, it provides EPA an
opportunity to review and evaluate information about a chemical
to determine if its manufacture, if its processing, commercial
use, or disposal should be limited, delayed, or prohibited. To
do this job, pre-manufacturing notices, PMNs, submitted to EPA
include information on chemical identity, description of
byproducts, anticipated production volumes, molecular formula,
intended categories of use, and other available information on
the substance. EPA can employ predictive modeling technologies
to help it decide if a new chemical raises concerns. EPA then
may also extend the review period of a chemical or new use of a
chemical if it needs more than 90 days to consider all of the
facts before acting. EPA then decides whether entry into
commerce is allowed, allowed with restrictions, allowed after
submission of additional data, or allowed with certain
regulatory or testing actions applied. As of May, 2013, I am
told that 52 percent of chemicals for which EPA received a pre-
manufacturing notice, PMN, actually went to market. According
to former EPA Chemicals Office Director Charlie Auer, who
testified at our June hearing, 90 percent of new chemicals
program decisions are made within 90 days, and over 15,000 new
chemicals, or 30 percent, have received some kind of regulatory
action under TSCA Section 5.
We want EPA to have information to make good decisions
about a chemical; however, we must be careful about disclosure
of that detailed information, obviously. In a recent paper on
trade secret privacy, William Fitzpatrick and two others
suggested that approximately 70 percent of the market value of
U.S. firms resides in their trade secrets and their
intellectual properties. This is what drives innovation.
TSCA Section 14 protects information submitted to the EPA
as a privileged and confidential trade secret. Disclosure by
EPA employees is not permitted, except to other federal
employees, or when necessary to protect the health or the
environment. Beth Bosley, who with six employees operates a
specialty chemical maker in Pittsburgh, reinforced these points
at our last meeting: one, disclosure of chemical identity may
be all it takes to give a way a competitive advantage to an
offshore manufacturer; and second, the majority of Freedom of
Information, FOIA Act requests to EPA on new chemicals come
from potential competitors, many of which are overseas, not
curious members of our public.
While we cannot have a system that prevents regulators from
having access to information that allows them to make important
judgments on risk, I think we should not be naive about the
value of this information to non-regulatory interests, their
cleverness in trying to obtain and exploit, and the real damage
its leak could cause to American jobs and our prosperity.
I want to thank 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
shortcomings lie. I urge members of the subcommittee to make
every effort at this hearing to learn the fundamentals of these
sections of this law, TSCA.
[The prepared statement Dr. Gingrey follows:]
Prepared statement of Hon. Phil Gingrey
Last month, the subcommittee held a hearing on the history
and impact of Title I of the Toxic Substances Control Act
(TSCA). The June 13th hearing was a good start to understanding
a law as complex as it is broad. Today, we take a deeper dive
and focus on new chemical regulation, protection of sensitive
business information, and their effect on innovation.
I believe evaluating TSCA sections 5 (new chemicals) and 14
(disclosure of data) is fundamental to judging progress in new
technologies and manufacturing frontiers in our country.
Testimony in our June 13th hearing supports this notion:
American companies are on the cutting edge of chemical
innovation, and the new chemical structure in TSCA has allowed
us to lead the world. For example, the European Union's new
chemical requirements saw 3,000 new chemicals introduced while
the United States saw six times as many new chemicals
introduced over the same period in time.
One out of six of the chemicals currently used in commerce
did not exist in 1979. TSCA Section 5 does not merely set out
the notification requirements for these chemicals; it provides
EPA an opportunity to review and evaluate information about a
chemical to determine if its manufacture, processing,
commercial use, or disposal should be limited, delayed, or
prohibited.
To do this job, Pre-Manufacturing Notices (PMNs) submitted
to EPA include information on chemical identity, description of
byproducts, anticipated production volumes, molecular formula,
intended categories of use, and other available information on
the substance. EPA can employ predictive modeling technologies
to help it decide if a new chemical raises concern. EPA may
also extend the review period of a chemical or new use of a
chemical if it needs more than 90 days to consider all the
facts before acting. EPA then decides whether entry into
commerce is allowed, allowed with restrictions, allowed after
submission of additional data, or allowed with certain
regulatory or testing actions applied.
As of May of 2013, I'm told that 52 percent of chemicals
for which EPA received a Pre-Manufacturing Notice (PMN),
actually went to market. According to former EPA chemicals
program office director, Charlie Auer, who testified at our
June hearing, 90 percent of new chemicals program decisions are
made within 90 days and over 15,000 new chemicals--or 30
percent--have received some kind of regulatory action under
TSCA section 5.
We want EPA to have information to make good decisions
about a chemical. However, we must be careful about disclosure
of that detailed information. In a recent paper on trade secret
piracy, William Fitzpatrick and two others suggested that
approximately 70 percent of the market value of U.S. firms
resides in their trade secrets and intellectual properties.
This drives innovation.
TSCA section 14 protects information submitted to EPA as a
privileged and confidential trade secret. Disclosure by EPA
employees is not permitted, except to other federal employees,
or when necessary to protect health or the environment.
Beth Bosley, who--with six employees--operates a specialty
chemical maker in Pittsburgh, reinforced these points at our
last hearing:
1. Disclosure of chemical identity may be all it takes to
give away a competitive advantage to an offshore manufacturer,
and
2. The majority of Freedom of Information Act requests to
EPA on new chemicals come from potential competitors, many of
which are overseas, not curious members of the public.
While we cannot have a system that prevents regulators from
having access to information that allows them to make important
judgments on risk, I think we should not be naive about the
value of this information to non-regulatory interests, their
cleverness in trying to obtain and exploit it, and the real
damage its leak could cause to American jobs and prosperity.
I thank 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 shortcomings lie.
I urge members to make every effort at this hearing to
learn the fundamentals of these sections of this law.###
Mr. Gingrey. I now yield 5 minutes to the ranking member of
our subcommittee, Mr. Tonko from New York.
OPENING STATEMENT OF HON. PAUL TONKO, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF NEW YORK
Mr. Tonko. Thank you, Mr. Chair. Good morning, and I am
pleased to be here this morning for this second hearing on the
Toxic Substances Control Act, better known as TSCA. And thank
you, Chair Gingrey, Dr. Gingrey. I am sure you will do an
excellent job of filling in for our colleague, Chairman
Shimkus, who cannot be with us today. It is a pleasure to be
with you at the hearing. And welcome to all of our
distinguished guests as members of the panel.
Our first hearing provided a very useful overview of the
Toxic Substances Program administered by the Environmental
Protection Agency. We have an opportunity today to hear from an
excellent panel of witnesses on two particular aspects of this
law, Section 5, the New Chemicals Review Program, and Section
14, the provision that governs the handling of confidential
business information.
The New Chemicals provision was intended to provide an
opportunity to screen new chemicals coming into commerce for
possible safety problems. The process was also to provide
sufficient information about the chemicals in commerce to
enable EPA to make a credible evaluation of their safety.
The law currently falls short of these goals. The
information available on chemicals has failed to keep pace with
the numbers of chemicals in commerce. We have developed
incredible analytical, computational, and communications tools
over the past few decades. We should be able to apply these
tools more effectively to produce reliable information about
the chemicals in commerce and make it available to the public,
but this has not happened to the extent needed. An effective
early evaluation process also provides benefits to industry.
Prevention certainly is much less expensive than mitigation.
The earlier a company detects a potential problem with their
product, the easier and less expensive it is to engineer around
that problem or to pursue a different design.
We need chemicals. We use them every day in a wide range of
products essential to the quality of our lives and to our
modern society. But these products must be safe for people and
must be safe for the environment. We need to find the proper
balance. The program must enable manufacturers to bring new
chemicals to the market while providing assurances to the
public that these substances are indeed safe. EPA needs
sufficient resources to evaluate chemicals in an expeditious
and reliable manner, and the authority to remove problem
substances from the market in a timely and orderly fashion. In
a fast-paced, competitive global economy, protecting trade
secrets is important and is challenging, but an overuse of
confidential business information claims is unwarranted and
serves only to bar the members of the public from information
they need to make informed choices about the products they
purchase and that they use.
I expect we will hear a variety of views today on the type
of extent of changes that are needed to improve this law.
Working together, however, we can update and improve this law
so that it works for everyone.
I look forward to the testimony of all of our expert
witnesses, and I thank you all for participating this morning
and for sharing your views on what I believe is an incredibly
important topic. Thank you.
With that, Mr. Chairman, I yield back.
Mr. Gingrey. I thank the gentleman from New York, and if
there are any other members seeking time for an opening
statement--seeing none, the chair wishes to recognize Mr. Latta
for the purpose of introducing the first two of our witnesses.
I yield to the gentleman from Ohio.
Mr. Latta. Well I thank the chairman for yielding to me,
and I appreciate it. I would just like to introduce our two
first witnesses today, and both from Ohio. You know, in the
Buckeye State, we like to stick together.
Our first witness that will be testifying today is Mr.
Craig Morrison, and Mr. Morrison is the President and Chief
Executive Officer of Momentive Performance Materials Holding,
and its operating subsidies--subsidiaries. It is based in
Columbus, Ohio, and Momentive is a world leader in specialty
chemicals and materials.
Our next witness that will be testifying is from Procter
and Gamble, and that is Mr. Len Sauers, who is Vice President
for Global Sustainability, Product Safety, and Regulatory
Affairs. Of course, Procter and Gamble is located in
Cincinnati.
I just want to thank you both for being here to testify,
and with that, Mr. Chairman, I yield back.
Mr. Gingrey. And I will now introduce our other three
witnesses. Mr. David Isaacs is Vice President of Government
Affairs for the Semiconductor Industry Association. Welcome,
Mr. Isaacs. Dr. Rainer Lohmann. Dr. Lohmann is a professor of
oceanography from the University of Rhode Island. Welcome,
Professor. And last, but certainly not least, Ms. Heather
White, Executive Director of the Environmental Working Group.
So I welcome all of our witnesses, and our first witness, we
will start with Mr. Morrison. You are recognized for 5 minutes.
I want to tell the witnesses that I am going to have a soft
gavel, so don't worry about--I am not going to let you go 10
minutes, but I certainly could let you go 5 \1/2\ to 6, and
anything that you want to say that you don't get time to say, I
ask unanimous consent for that to be submitted for the record.
Hearing none, so ordered, and we will start with Mr. Craig
Morrison.
STATEMENTS OF CRAIG MORRISON, CEO OF MOMENTIVE PERFORMANCE
MATERIALS HOLDING, LLC, AND CHAIRMAN OF THE EXECUTIVE
COMMITTEE, AMERICAN CHEMISTRY COUNCIL; LEN SAUERS, VICE
PRESIDENT, GLOBAL SUSTAINABILITY, PROCTER AND GAMBLE; DAVID
ISAACS, VICE PRESIDENT, GOVERNMENT AFFAIRS, SEMICONDUCTOR
INDUSTRY ASSOCIATION; RAINER LOHMANN, PROFESSOR OF
OCEANOGRAPHY, UNIVERSITY OF RHODE ISLAND; AND HEATHER WHITE,
EXECUTIVE DIRECTOR, ENVIRONMENTAL WORKING GROUP
STATEMENT OF CRAIG MORRISON
Mr. Morrison. Thank you, Mr. Chairman. I am Craig Morrison,
President and Chief Executive Officer, and Chairman of
Momentive Performance Materials based in Columbus, Ohio. I am
testifying today on behalf of the American Chemistry Council,
the ACC, where I am currently chairman of the board of
directors. On behalf of the ACC and our members, I would like
to thank the chairman and the committee for holding today's
hearings.
Momentive is a world leader in the development and
production of specialty chemicals and materials. Momentive
chemistries are used in thousands of products that enhance the
safety, convenience, and efficiency of modern life. Our
products can be found in automotive, energy, construction,
personal care, electronics, and many other segments. In fact,
Momentive materials can be found in the semiconductors produced
by some of the members of the Semiconductors Industry
Association, represented here by my fellow panelist, Mr.
Isaacs. Momentive has over $7 billion in sales and operates 90
manufacturing facilities in 37 countries, including 35
manufacturing facilities in 18 States in the U.S., which
provides approximately 4,000 American women and men high paying
manufacturing jobs.
Innovation is critical to the survival and growth of our
industry and the downstream industries that we supply. To
remain a market leader, our process of research, development,
product testing and introduction is nearly constant. That is
why an efficient, effective process to evaluate and approve new
chemical innovations is vitally important to the chemical
industry and why I will be focusing my comments on Section 5 of
the Toxic Substances Control Act, known as the New Chemicals
Program.
There is broad agreement among industry and other
stakeholders that TSCA needs to be reformed in order to reflect
modern understanding of chemicals and today's scientific
knowledge. We have been encouraged by the recent introduction
of the bipartisan Chemical Safety Improvement Act in the Senate
and by this committee's interest in examining current law to
gain a better understanding of needed reforms. But it is also
widely understood that TSCA's New Chemicals Program works well,
a fact that has been reinforced by senior officials from
previous administrations of both political parties.
New chemicals undergo a thorough but efficient multi-step
regulatory review before being approved for manufacture and
marketing. This well-functioning framework has three particular
strengths. First, the program ensures a scientifically robust
review of the potential hazards and exposures associated with a
chemical substance. Second, it allows the EPA to tailor the
process to fit the specific characteristics of an individual
chemistry. And third, the process and timing of EPA's review
generally meets demands of the marketplace.
The program leverages significant data about chemicals
already available to the EPA, and employs advanced modeling
techniques to predict a new chemical's physical and chemical
properties, health hazards, and potential environmental
effects. Section 5 also gives the EPA, which it regularly
exercises, to request more testing and data about a new
chemical if the Agency feels it is necessary, and to manage
potential risks appropriately. This sophisticated risk-based
approach reduces the cost of innovation and time needed for
review and approval of new chemical products. It has
facilitated a dialog between manufacturers and regulators that
has helped industry move away from potentially problematic
chemistries and has enabled the introduction of even safer and
more sustainable chemistries.
Momentive submits, on average, 10 new chemistries for
review each year, and has submitted approximately 120 new
chemistries for review over the past 10 years. Thanks to the
EPA's efficient and well-functioning process, 90 percent of
these new products introduced in the last 5 years have been
able to come to market without the need for new animal testing.
The advantage created by TSCA Section 5 for American innovation
and competitiveness is clear. For example, the chemical
industry invests $11 billion on average each year in research
and development. Roughly 20 percent of all U.S. patents are
chemistry-related. Three times more chemical innovations are
brought to the market in the U.S. than other major regions of
the world, such as Europe and Japan. Taken together with
abundant, affordable supplies of domestic natural gas, the
current New Chemicals Program helps create a strong incentive
for companies that rely on chemistry to invest in the U.S. In
fact, as of June, 2013, more than 100 new plants, expansions,
and restarts of previously shuttered sites have been announced,
which is projected to create 310,000 new American jobs by 2020.
TSCA Section 5 established a rigorous process to evaluate
and approve new chemistries in a way that protects health and
the environment, enables continuous innovation, and allows new
transformative products to come to market. Ensuring that this
remains the case as part of any new effort or reform to
modernize TSCA should be a top priority.
Thank you very much for allowing me to participate, and I
am happy to answer any questions.
[The prepared statement of Mr. Morrison follows:]
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Mr. Gingrey. Mr. Morrison, thank you.
We will now hear from Mr. Len Sauers, Vice President of
Global Sustainability with Procter and Gamble. Mr. Sauers, 5
minutes.
STATEMENT OF LEN SAUERS
Mr. Sauers. Thank you, Mr. Chairman and Ranking Member
Tonko, members of the committee. Thank you for inviting me here
today. As has been said, my name is Len Sauers. I am the Vice
President for Sustainability, Product Safety, and Regulatory
Affairs at the Procter and Gamble Company.
P&G is the largest consumer products company in the world.
Our products are used by 4.6 billion people around the world
every day. We have operations in nearly 80 countries, and 99
percent of American households have at least one P&G product in
their home. Since our founding over 175 years ago, innovation
has been integral to everything we do, and has been critical to
our success. To support our innovation efforts today, we have
dedicated R&D facilities in five continents, and we employ over
9,000 R&D employees.
P&G supports comprehensive modernization of TSCA for two
primary reasons. First, federal action is urgently needed to
enhance consumer confidence in the safety of the ingredients
that they use in their everyday household products; and
secondly, reform will give States confidence in a strong
federal chemical management system, and thereby avoid a
patchwork of varying requirements across multiple States, which
will slow innovation and increase complexity.
I would like to turn now to the regulation of new
chemicals. Over the past 30 years, P&G has either submitted or
been the major contributor to over 175 pre-manufacture notices.
From our experience, we believe that both the law and EPA's
governance of the New Chemicals Program have provided for
scientifically robust reviews of the potential hazards and
exposures of new chemicals entering the U.S. market and ensured
appropriate health and environmental protection.
There are many strengths to EPA's New Chemicals Program.
One is the ability to tailor customly the data submitted in a
PMN to the specific new chemical, as opposed to requiring a
minimum data set. This approach assures that the information
which is necessary and relevant to evaluate the safety of the
chemical is received. EPA also utilizes modern science, such as
sophisticated predictive models and structure activity
relationships to evaluate new chemicals. New safety data is
only requested when necessary to make decisions, thereby
avoiding unnecessary animal testing. EPA is very receptive to
pre-submission consultations with companies to help them plan
for and anticipate the needs that EPA will have during their
review. And finally, when deemed necessary, EPA has a broad
range of regulatory tools that they can use to limit exposure
to a new chemical.
New chemical review is a key element of TSCA. It is P&G's
opinion that the new chemical provisions of TSCA function
efficiently and effectively.
Now I would like to turn to confidential business
information. P&G invests over $2 billion annually in research
and development. We have a significant interest in protecting
our new to the world chemistries and confidential business
information from public disclosure to our competitors. We rely
heavily on the protection of confidential business information
afforded by Section 14 of TSCA to remain competitive in the
marketplace, and are very concerned with EPA's recent decision
to reverse current practice and publically disclose the
specific structure of chemicals for which companies currently
consider confidential, when the health and safety studies of
these chemicals are made public.
P&G fully supports transparency when health and safety
information in EPA's administration of TSCA Section 14 and we
agree that all health and safety data should be made public,
but the disclosure of specific, confidential chemical
identities is not needed for one to understand the safety of a
new chemical. Structurally descriptive, generic chemical names,
like those P&G provides today on its Web site as part of our
consumer information program are sufficient. For example,
consider P&G's development and market introduction of Tide Cold
Water laundry detergent. P&G's scientists discovered a new
technology that enabled consumers to get the same cleaning
performance in cold water as they expected in hot or warm. This
innovation enabled them to save money on their energy bills and
meaningfully decrease their greenhouse gas emissions by no
longer having to heat water for laundry. P&G submitted two PMNs
to EPA to create Tide Cold Water. Over 150 pounds of safety
data were submitted with the PMN, and we requested that the
specific chemical structure of our new technologies be kept
confidential to prevent our competitors from piecing together
the required chemistry needed to duplicate the formula. P&G's
development costs of the two PMNs totaled about $150 million.
EPA'S new interpretation of TSCA Section 14 would have meant
disclosing to competitors those confidential chemical
identities and allowing them to benefit from our work without
an investment on their part.
A modernized TSCA must continue to strike the right balance
of protection of confidential business information with public
access to health and safety information about chemicals in
commerce.
Mr. Chairman, Ranking Member Tonko, thank you again for the
invitation to testify this morning. P&G values our partnership
with you and this subcommittee, and we remain committed to
working with you to develop a practical, scientifically sound,
chemical management program that strengthens protection of
human health and the environment, and ensures U.S. leadership
of sustainable innovation in the global marketplace. Thank you.
[The prepared statement of Mr. Sauers follows:]
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Mr. Gingrey. Mr. Sauers, thank you.
Next witness, Mr. David Isaacs, Vice President of
Government Affairs, Semiconductor Industry Association. Mr.
Isaacs, you are up for 5 minutes.
STATEMENT OF DAVID ISAACS
Mr. Isaacs. Thank you, Mr. Chairman and Ranking Member
Tonko, and members of the subcommittee. My name is David
Isaacs, and I am testifying on behalf of the Semiconductor
Industry Association.
SIA is the trade association of U.S.-based semiconductor
companies that design and manufacture semiconductors, and as
many of you know, semiconductors are the integrated circuits or
sometimes called computer chips that are the basic building
block for all modern electronics. These innovations enable the
revolution we have experienced in information technology,
communications, transportation, medical devices, and national
defense, so they are a fundamental part of our economy and
American economic leadership.
Our industry employs directly a quarter of a million people
in the United States, and supports over a million indirect
jobs. We are consistently among the top export industries in
the United States, and a key part of America's advanced
manufacturing infrastructure.
So before I speak to our views on the current TSCA system,
I wanted to provide some context on our industry's use of
chemicals. Our industry relies, in our manufacturing processes,
on the--on specific chemicals that have particular chemical and
physical properties and unique functional attributes that
enable us to produce, you know, up to a billion transistors on
a chip the size of your fingernail. We integrate these
chemicals in advanced manufacturing equipment with high levels
of precision, very rigorous controls, and enclosed processes,
high levels of automation, and that results in a very precise
process and also an exemplary environmental and safety record.
And that background informs our views on the New Chemical
Program. We believe that the existing program generally strikes
the right balance between environmental protection and the
approval of new chemicals that help drive our innovation. It is
important to note that semiconductor companies do not
traditionally submit PMNs for approval by the EPA, and we rely
on our chemical suppliers for that function, but we have a
strong interest in ensuring our access to new chemicals that
can help drive our advances.
The key attributes of the current system are the risk-based
approach, and as others have mentioned, the tailored and
customized evaluation of chemical uses. In our industry, the
unique attributes of our manufacturing processes result in very
low levels of risk and exposure, and we believe that that very
much needs to be kept into account in any reform efforts going
forward.
My testimony outlines other attributes of the system that
we think are very important, such as an expedited timeframe
that allows speed to market, and critical exemptions for
activities like research and development. And then, of course,
the protection of confidential business information is critical
to our industry as well. Our industry is very much driven by
intellectual property. We invest, on average, 18 percent of
revenue into R&D. Last year, that amounted to $32 billion in
R&D investments. We are a leader in patents and many of our
processes are protected as trade secrets. So the protection of
CBI under the TSCA is very, very important to us, and we think
it generally works well and strikes the right balance between
the need for the public to have available information on health
and safety data while at the same time protecting confidential
business information.
So going forward, we look forward to working with the
Congress and this subcommittee on efforts to modernize TSCA and
we would like to play a constructive role in that effort. So
thank you very much for the opportunity to testify.
[The prepared statement of Mr. Isaacs follows:]
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Mr. Gingrey. Mr. Isaacs, thank you. Yielding back 13
seconds.
Next witness, Mr.--excuse me, Dr. Rainer Lohmann, Professor
of Oceanography at the University of Rhode Island. Dr. Lohmann,
5 minutes.
STATEMENT OF RAINER LOHMANN
Mr. Lohmann. Good morning. Dear members of the House
Committee on Environment and the Economy, I want to thank you
for inviting me to testify today. I would also like to thank my
wife for letting me go to D.C. on our wedding anniversary. My
name is--I will be back tonight. My name is Rainer Lohmann. I
am professor of oceanography at the University of Rhode Island.
I have spent the last 15 years researching organic contaminants
around the world. My written testimony contains several more
recommendations on TSCA reform that I worked on with my
colleagues, Dr. Heather Stapleton from Duke, and Dr. Ron Hites
from Indiana. I will use excerpts here.
First, open dialog, not CBI. Let me frame my testimony by
quoting Andrew Liveris, CEO of Dow Chemical. ``Over the
decades, the chemical industry has not done enough to operate
with transparency and to lead on matters such as
sustainability, spawning legacy issues that we are still
resolving today. Further,'' he said, ``the chemical industry
went from defiance, then denial towards debate, and finally has
reached dialog.'' In this spirit, I submit that the current use
of CBI is in strong conflict with dialog and transparency. TSCA
does not limit the period in which a chemical can be considered
proprietary or a trade secret. Even new pharmaceuticals, which
are much more expensive, are only pertinent for up to 20 years,
providing a drug company time to recoup its research investment
and make a profit. Within TSCA, the chemical industry should
have limited time during which the information submitted to the
EPA will be considered proprietary. After this time,
information should be publicly available, including site
specific production volumes. The public has a right to know
what is produced and where. This will foster dialog, build
trust, and eventually lead to safer chemicals on the market.
In addition, because research on many chemicals is hindered
by a lack of authentic standards, samples of any chemical
substance produced or imported into the U.S. should be archived
in a national repository funded by the chemical industry. This
will open dialog between industry academia and geos to identify
worst compounds and assess safer alternatives.
Second, spur innovation. We need safer, newer, and green
chemicals as part of chemistry's contribution towards
sustainability. How do we get there? First, we need to identify
and replace the worst chemicals in commerce, those which are
strongly bioaccumulative, persistent, and toxic. Priority
should be given to reassessing the chemicals that were
grandfathered in TSCA. This will spur industry to invent,
establish, and market safer alternatives.
How big is the problem? The TSCA inventory contains
probably hundreds to thousands of chemicals that are
persistent, bioaccumulative, and toxic at the same time. Many
of these are found in the environment and in humans. Recent
examples include perfluorinated compounds and brominated flame
retardants, both of which are present in roughly 97 percent of
the U.S. population, including children, and the environment.
Our efforts to fully understand the presence and effects of
persistent organic chemicals in the environment are hampered by
a lack of basic information about the chemical identity,
properties, toxicology, and production volumes. Some of that
information is currently protected by CBI.
Moving forward, TSCA reform should make use of EU's REACH
Program. The information on chemicals that are submitted as
part of REACH should be able to be used in the U.S. to move
toward safer and greener chemicals at no additional cost,
basically.
Third, testing of new chemicals. Dr. Heather Stapleton
discovered Firemaster 550 by accident while she was screening
house dust samples for PBDEs, which are basically phased out in
the U.S. Her research on dust and hand wipe measurements
demonstrated that Firemaster 550 is a ubiquitous indoor
contaminant, and exposure is highest for infants and toddlers,
rather than adults. Last year, she already showed that
Firemaster 550 is the second most common flame retardant in
residential furniture today, and it might be number one as we
speak. In their most recent work, Dr. Stapleton and colleagues
demonstrated that prenatal exposure to Firemaster 550 in rats
resulted in obesity, early puberty, insulin resistance, and
disruptive thyroid hormone signaling.
I would like to stress the effects of exposure to chemicals
in our households with typical modern health problems, obesity,
early puberty, diabetes. In 2005, EPA issued a consent order
requesting that Chemtura, the manufacturer, conduct more
testing on Firemaster 550's health effects. Of the four
ingredients that the Firemaster has, two were grandfathered in
TSCA, so EPA could only require testing on the two new
brominated compounds, and not the entire mixture. This
highlights the shortcomings of TSCA, and how it violates common
sense. If you market a chemical mixture, you should perform
toxicity tests on that whole mixture as it will be used and how
people will be exposed to it in the environment and in their
households.
Professor Stapleton's research on Firemaster 550 is the
only study to date to examine health effects from the mixture
as it is used today. The data demonstrated that significant
effects occur at much lower doses than what the chemical
company declared to be safe.
In closing, I would like to note that my research has been
funded by the NSF, the U.S. EPA, and the Hudson River
Foundation, and I thank you for your attention.
[The prepared statement of Mr. Lohmann follows:]
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Mr. Gingrey. Dr. Lohmann, thank you for your testimony.
I will now turn to Ms. Heather White, Executive Director of
the Environmental Working Group. Ms. White, 5 minutes.
STATEMENT OF HEATHER WHITE
Ms. White. Mr. Chairman and distinguished members of the
subcommittee, I am Heather White, Executive Director of
Environmental Working Group, a nonprofit research and advocacy
organization based in Washington, Iowa, and California. Thank
you for the opportunity to testify.
EWG wants the United States to be the world leader in
innovative chemical production. Some of the best and brightest
scientists in the world are at the companies represented here
today, but innovation is not just about lowering costs and
boosting profits. Americans believe that innovation must also
mean creating chemicals that are not just cheap, but safe.
Strong chemical regulation promotes innovation. We cannot
compete internationally on labor or production costs. We will
not win that race to the bottom. But America ultimately will
win on chemical quality and safety through toxics law reform.
For 20 years, EWG has advocated greater protection of
people and the environment from toxic chemicals. Our
groundbreaking research detected nearly 300 toxic industrial
chemicals in the umbilical cord blood of newborn babies. The
reality is industrial chemical pollution begins in the womb.
Yet a century into the chemical revolution, we still don't know
what these low level exposures to substances, alone or in
combination, do to our health, especially our children's
health. No one has basic answers, not the government, academic
researchers, or the chemical industry.
In 2010, the President's Cancer Panel concluded that the
number of cancers caused by toxic chemicals is grossly
underestimated. Americans have lost faith in a chemical
regulatory system that they suspect, with good reason, doesn't
protect them and their children. Many of these chemicals have
not been adequately tested for safety under the Toxic
Substances Control Act. Its New Chemicals Program is woefully
inadequate, and its secrecy provisions threaten human health.
There are three major problems with the New Chemicals
Program. First, most Americans assume that a chemical can't be
sold until proven safe. Not so. A chemical company can get a
new chemical on the market today without providing any
information about the toxicity of that chemical. Companies do
it every day. In fact, 85 percent of the pre-manufacture
submissions have zero information about the toxicity of these
new chemicals. Second, EPA faces a chemical Catch-22. The
agency cannot demand more test data without solid evidence that
the new chemical could be a reasonable risk, and it cannot come
up with that evidence without the test data. The law places the
burden on EPA, not the manufacturer, to determine whether a new
chemical is unsafe before it goes into use. The trouble is that
chemicals are entitled to a presumption of innocence. That
works in criminal law, but that shouldn't exempt chemicals from
investigation. Not surprisingly, EPA attempts to restrict less
than 10 percent of new chemicals. Finally, chemical makers
don't necessarily know how the chemical might be used when they
make it. After a new chemical is approved, they do not have to
tell EPA when the planned use changes.
As for secrecy, the current law's Confidential Business
Information scheme is a regulatory black hole where critical
information goes in, and little comes out. Even the
intelligence community declassifies highly sensitive
information after a while, but TSCA confidentiality claims
never expire.
Companies have a legitimate interest in keeping some
information confidential, but unwarranted claims directly
threaten human health and the environment. TSCA permits a
manufacturer to claim confidentiality without substantiation
for virtually any information it submits to EPA.
Confidentiality claims mask the identities of nearly \2/3\ of
all new chemicals introduced since 1976, including substances
used in consumer and children's products.
Chemical makers assert that secrecy protects their
competitive advantage, but they knew very well that competitors
commonly reverse engineer their products. Everybody else is
left in the dark: ordinary citizens, first responders, workers,
medical personnel, independent researchers, State and local
governments, and fence line communities that are often hotspots
of chemical exposure.
We deserve better. Congress can overhaul the broken toxics
law to protect public health and the environment, and at the
same time, spur development of better, safer, innovative
chemicals.
Thank you, and I welcome any questions you may have.
[The prepared statement of Ms. White follows:]
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Mr. Gingrey. Thank you, Ms. White.
We will now turn to questions from the members of the
subcommittee, and each will have 5 minutes. I will say to the
members, if you decide to speak for 4 \1/2\ minutes and give a
speech, and then ask a question in the last 30 seconds, I will
let the witness respond to the question.
I will begin yielding to myself for the first 5 minutes,
and my first question is going to be to Monsieurs Morrison,
Sauers, and Isaacs, the first three witnesses. How do TSCA
regulations for new chemicals and new uses and TSCA provisions
on the production of Confidential Business Information affect
your ability to innovate? Mr. Morrison first, then Mr. Sauers,
then Mr. Isaacs.
Mr. Morrison. Thank you, Mr. Chairman. For us, innovation
is our lifeblood and what allows us to succeed and our economy
to succeed is delivering performance capability to our
customers, such as the two gentlemen to our left, with unique
products, and our chemical formulations are at the heart of
those products. What TSCA has allowed us to do is drive that
innovation and also ensure that it is safe from a health and
environmental standpoint, but protect the necessary information
so that it is not disseminated to foreign governments, et
cetera.
If you look at our company alone, we have had multiple
cyber attacks by foreign governments that we were unaware of
that the Federal Government made us aware of and notified us
that our IP and other trade secrets had been penetrated and was
being downloaded. That is exactly the information we are
discussing today and that we need to protect, and that we are
talking about if we change TSCA where we voluntarily disclose
that information, we lose the very competitive advantage that
we deliver to our company, to our customers, and to the U.S.
economy.
Mr. Gingrey. Mr. Sauers?
Mr. Sauers. Thank you, and maybe I will just add to what
Mr. Morrison has said. Innovation is quite important to Procter
and Gamble, you know, as a company of $90 billion in sales,
9,000 R&D employees. It is something that is very important to
us, and what we have appreciated most about TSCA has been our
ability to get our chemicals into commerce in a very reasonable
timeframe and work with an agency that is highly competent in
the evaluation of the safety of these materials. We have
appreciated very much the opportunity to sit down with EPA
scientists prior to the submission of a PMN to talk about our
chemical, talk about the safety needs that TSCA will have, the
EPA will have, to make sure that what we bring forward to them
is complete. We have appreciated the risk-based approach that
the agency has used. We have also appreciated their sensitivity
to animal testing. The Procter and Gamble Company has spent
about $300 million over the years developing methods to prevent
the needless killing of animals for safety testing through the
development of predictive methods, structure activity
relationships, modeling, and things like that, and we
appreciated the EPA incorporating those technologies.
Mr. Gingrey. Mr. Isaacs?
Mr. Isaacs. Mr. Chairman, as I outlined in my comments and
in my testimony, we very much rely on the continued access to
new chemicals as part of our ability to advance in
semiconductor manufacturing. We believe that our processes are
fundamentally based on automated systems and enclosed processes
that result in minimal exposure, very limited releases to the
environment, and therefore, we think our responsible use of
chemicals, along with other environmental laws, protects human
health and the environment in an appropriate manner.
Mr. Gingrey. Thank you. In my time remaining, I am going
to--probably I will only time for one more question and I will
direct it to Mr. Morrison. How does TSCA's New Chemicals
Program work in practice? Could you walk me through
manufacture, pre-manufacturing notice submission, that EPA 90-
day review, and notice of commencement?
Mr. Morrison. Yes, sir. Well essentially we start off by
conducting our own tests on the chemicals, and then we put
together a pre-manufacturing notice, which is the PMN submitted
to the EPA. They scrutinize the data. They apply that to
predictive models and analogous materials. They then go ahead
and assess the various chemical properties. They look at the
exposure potentials and risks, and ultimately come out with a
ruling that could be a pass, a limited use, a restricted, or in
fact, stop the PMN from going forward and require more testing.
If it is approved, either under restricted or fully
approved to go ahead, then we are given permission and we issue
a notice of commencement of the manufacturing process at that
point. Essentially, this usually takes approximately a 90-day
period, which is key because it allows us to turn our
innovation in a timely manner, and in many industries, like
semiconductor and others, that is absolutely critical for their
success.
Mr. Gingrey. You heard the testimony from Dr. Lohmann and
from Mrs. White--Ms. White, and their concerns. Are there any
exemptions, exclusions from the new chemicals provisions of
TSCA?
Mr. Morrison. There are some, such as certain sets of
polymers and other materials, that the EPA has very extensive
experience with that they know don't pose any hazard or risk,
and therefore, they are exempted from the process because it
makes the EPA and it makes the chemical companies much more
efficient, rather than just submitting everything where there
is no added benefit to submission.
Mr. Gingrey. I thank all three of you and I have gone
almost a minute over. At this point, I will yield 5 minutes to
the ranking member of the subcommittee, the gentleman from New
York, Mr. Tonko.
Mr. Tonko. Mr. Chair, the ranker of the Energy and Commerce
Committee has a conflict with scheduling, so I would ask if you
call upon your----
Mr. Gingrey. Absolutely. I will be glad to yield to the
ranking member of the overall Committee of Energy and Commerce,
the distinguished gentleman from California, Mr. Waxman, for 5
minutes.
Mr. Waxman. Thank you, Mr. Chairman, thank you, Mr. Tonko.
Four years ago, this committee spent a considerable time
examining the Toxic Substances Control Act, and worked to craft
policy solutions for its failures. It was a challenging
endeavor, because we found that even as some in industry claim
to want to make our regulatory system safer, we found strong
resistance to actual reform. Mr. Morrison, you testified that
Section 5 is ``one of the major successes of TSCA, and that we
should be careful to preserve its essential elements.'' I would
like to take a moment to examine one chemical that has gone
through Section 5 review, Firemaster 550. It is a flame
retardant that as Dr. Lohmann has stated is gaining significant
market share in the United States.
The maker of this flame retardant, Chemtura, markets this
chemical as a safer alternative, saying that it has ``an
improved environmental profile'' compared to its predecessors.
In promotional materials, Chemtura touts EPA's review of
Firemaster 550 under Section 5 as ``extensive'' and states that
``consumer exposure is extremely low.''
But as Dr. Lohmann reports, scientists have shown that
consumers are being exposed to this product at significant and
dangerous levels.
Dr. Lohmann, can you elaborate briefly on some of the
exposure and hazard data that has been produced on Firemaster
550?
Mr. Lohmann. Thank you for the question. I should point out
that is Dr. Stapleton's work from Duke University. What she has
shown builds on a legacy--well, it is almost an endless story.
It starts off with flame retardants, PBB, polybrominated
biphenyls, that were discovered by accident because they
contaminated cows in Michigan. They were withdrawn from the
market and replaced by polybrominated diphenyl ethers, which
were found to accumulate in blood in the U.S. adult population
10 times higher than Europe, so it was finally withdrawn from
the market to be replaced by Firemaster 550, which could only
be partially evaluated because it was a mix of grandfathered in
chemicals and new chemicals. And as all other flame retardants,
they are not physically bound or chemically bound to the
product, so they escape over time and mostly the exposure for
all of us is in our houses through dust.
Mr. Waxman. Ms. White, you mentioned in your testimony that
EPA didn't have access to all of the information it needed to
thoroughly evaluate Firemaster 550 before it went on the
market. Can you elaborate briefly on that?
Ms. White. Absolutely. Because of the draconian measures of
Confidential Business Information in TSCA, EPA's own scientists
weren't actually able to look at the full health and safety
profile, so the leading expert actually has said on the record
that if she had known about the issues of Firemaster 550, then
the chemical would not have been approved and there certainly
would have been a request for more chemicals.
Mr. Waxman. EPA developed a work plan to conduct a risk
assessment of numerous chemicals identified as potentially
hazardous, including a chemical that is the active ingredient
in Firemaster 550 known as TBB. EPA gave the active ingredient
in Firemaster 550 the worst score possible for exposure risks
and plans to assess it this year. Yet the promotional materials
for the product still say that it has been approved by EPA and
that consumer exposure is low.
Mr. Morrison, do you believe that Section 5 has worked in
the case of Firemaster 550?
Mr. Morrison. I think Section 5 in general works very
effectively. I haven't studied that in great detail from a
scientific standpoint or understand the full history of it. I
would be the first to admit that at times, more information
comes out and we have an obligation as an industry when we
identify a substantial risk, we have to notify the EPA if we
have additional data. Additionally, if the EPA determines there
is an unreasonable risk, they have every right to go back in
and revisit the chemical itself.
Mr. Waxman. So you would go back and revisit it, but Ms.
White, what do you think? Do you think that Section 5 worked in
the case of Firemaster 550?
Ms. White. Absolutely not. I think that that really is a
great example of how everything is turned upside down when it
comes to the New Chemicals Program, because we have the burden
of proof being on the EPA to raise this situation and raise
concerns about chemical safety, as opposed to the chemical
manufacturer fully disclosing and testing in advance and being
required to test the chemicals before they go on the market.
Mr. Waxman. Thank you. Firemaster 550 is already on the
market, in furniture, in baby products and other consumer
goods, and there are now serious questions about its safety. I
guess the question I think that raises is would the public have
been better served understanding these risks before it was
brought into widespread use?
I would like to introduce, Mr. Chairman, into the record a
letter from the Center for International Environmental Law
dated July 11, 2013. This letter summarizes work CIEL has done
to examine trends in chemicals regulation and patent filings to
evaluate the impacts of stronger rules for hazardous chemicals
on the innovation of new chemical products. They find that
stricter regulation of hazardous chemicals drives innovation
and creates a safer marketplace. They explained that
implementation of Section 5 has resulted in one dangerous
chemical being substituted for another dangerous chemical. They
point out that when a different approach is taken, when
dangerous chemicals are removed from the market, it accelerates
the invention of alternative chemical products. It makes a lot
of sense to me and I hope we can focus on getting this policy
as right as it can be.
Mr. Gingrey. Without objection, the letter is accepted into
the record.
[The information appears at the conclusion of the hearing.]
Mr. Gingrey. We now turn to the subcommittee chairman on
oversight, the gentleman from Pennsylvania, Mr. Murphy, for 5
minutes.
Mr. Murphy. I thank the panel for being here.
I want to start off, because it is always important for me
to hear from some of you your corporate philosophy, and I want
to ask you this, Mr. Sauers. Your corporate philosophy with
regard to dealing with the health and safety of your customers
and your employees when it comes to developing chemicals, could
you just describe to me what that is?
Mr. Sauers. Sure. Thank you, Congressman. I mean, I can't
think of anything more important to Procter and Gamble than the
safety of our customers and employees. Four point six billion
people use our products every day, so it is imperative that we
ensure that the products we put on the market are safe for them
and safe for the environment. I think to illustrate that best,
my department at Procter and Gamble has 700 employees in it,
200 of whom have PhDs in sciences related to human and
environmental safety. So everything we evaluate for the--to go
on the market has a thorough and comprehensive risk assessment
prepared for it to ensure that it is safe.
Mr. Murphy. Mr. Isaacs, do you have a comment on that?
Mr. Isaacs. Well as an industry, I think we have a similar
dedication to the protection of the environment and our
workers. My written testimony highlights some of the successes
we have had in substituting or phasing out materials of concern
in our processes and reducing emissions, and that remains a
very high priority for the industry globally.
Mr. Murphy. And again, Mr. Sauers, in the developing of
chemicals in your company, do you--and following what you said
as far as your mission of corporate responsibility, do you
review chemicals and make decisions that some of them should
not be brought to the market because in your determination,
they are not passing muster for health and safety?
Mr. Sauers. Yes, sir. We go through a complete evaluation
from the beginning of first proposal by our technologists.
Evaluating in the beginning, if we show that materials will be
problematic as they are marketed, for example, show
unreasonable sensitization, toxicities associated with various
organs or things like that, if we think those issues will be a
problem considering the exposure that individuals will get to
them, we will stop them. We have done that in many instances.
As a company, we chose not to market nonylphenol ethoxylates,
which were a major surfactant because of environmental quality
and their inability to be completely biodegraded. So those
decisions are made every day by our toxicologists.
Mr. Murphy. Thank you. Now for Mr. Morrison, Sauers, and
Isaacs, a question. As Congress is probably going to be dealing
with the TTIP, that is, dealing with the Transatlantic Trade--
Pretrade agreement coming up, one of the questions that is
going to come up is with regard to regulations between the
United States and European nations, and particularly, I am sure
that the question of sharing of CBI with State and foreign
governments, the TSCA permits, et cetera. I wanted to ask you
if any of you are anticipating any concerns in terms of should
States and foreign governments be permitted access to CBI, or
if you have begun to put any thoughts into how this would be
handled? Mr. Morrison?
Mr. Morrison. Yes, at this time we do not, as the ACC or I
as the CEO of a company, support sharing CBI with foreign
governments. We don't feel we have the ability to control and
protect that information. We do take a different stance on
sharing information with States where they demonstrate an
ability to protect the information, as well as an applicable
use around safety or environmental purposes. But we do not feel
secure in today's environment passing out CBI information
internationally, so we would not support that.
Mr. Murphy. Let me expand this, and the three of you, as it
goes through, because it is something we are going to have to
deal with, and there are regulatory issues how the United
States and the EU will deal with these issues to make sure that
any products that are sold across the Atlantic from either side
dealing with their environmental concerns and our environmental
concerns with health and safety of customers. So how do each of
you--what are your thoughts on does the EPA protect trade
secrets while still providing a mechanism for evaluation of
safety and health review? I will start with Mr. Morrison and go
across.
Mr. Morrison. Yes, I think there is very much a capability
to share the pertinent information without giving chemical
identity and other things that we currently protect. So the
important aspect around safety, environmental and et cetera, we
feel we are very capable of sharing that. What we don't agree
with is sharing the proprietary information such as chemical
identity.
Mr. Murphy. Do you feel that they protect that information,
or does it get out?
Mr. Morrison. Well, we have ability to protect that with
generic names that we talked about before, but we are afraid if
you gave out chemical identity, once it goes to other
governments you lose control of the ability to protect chemical
identity.
Mr. Murphy. A few more seconds. Mr. Sauers, with regard to
the EPA protecting that proprietary data while it is still
providing information to help them evaluate health and safety,
do you feel confident that they protect that top proprietary
information?
Mr. Sauers. Yes, I do, and I think there is a balance that
needs to be weighed here. There no CBI with the EPA itself. I
mean, they get full access to all the information and the
specific chemical names. I mean, they have full access so they
are able to make their evaluation. And then a generic, less
descriptive chemical name is given and that is what is made
public, which allows the public to be able to draw their own
conclusions about the material. And as a toxicologist, that
information that is provided is sufficient for individuals to
make evaluation and draw to corollary materials, for which
there is available information.
Mr. Murphy. Thank you. Mr. Chairman, I see my time expired
but I would hope that that question could also be forwarded to
the other panel members and ask for their response as well.
Thank you.
Mr. Gingrey. Thank you, Mr. Murphy. We now turn to the
ranking member from New York, Mr. Tonko, for 5 minutes.
Mr. Tonko. Thank you, Mr. Chair. Reviews by the Government
Accountability Office and testimony that we had heard at our
last hearing indicated shortcomings with respect to Section 5
of TSCA. Last year, EPA announced a work plan to conduct the
risk assessment of numerous chemicals identified as potentially
harming children's health, causing cancer or posing other
health concerns. Several of these chemicals were reviewed under
TSCA's Section 5 New Chemicals Program, but made it on the
market anyway.
So to Dr. Lohmann, my question is if we suspect a chemical
harms children's health or has another serious effect,
shouldn't we try to understand that before it goes on to the
market rather than after?
Mr. Lohmann. I would fully concur. You would expect these
days that we would first make sure a chemical is safe before we
produce it. Unfortunately, that is not the way it works in this
country right now.
Mr. Tonko. Well how could a stronger Section 5 provide
proactive protection for the American public?
Mr. Lohmann. What you see happening in Europe under the
REACH Program is that the manufacturers have to take
responsibility for their product and have to convince the
regulatory agency, in this case, the European Chemicals Agency,
to show that their product is safe in its different uses. So
the manufacturer has to go all the way through from cradle to
grave what I am producing is safe and where it is going to be
used. And that kind of approach really means the responsibility
is with the person or the company who makes it, and they have
to show it is safe. And that, I think, is a much more forward
looking approach than just having here is a new chemical, EPA,
just evaluate it quickly and we will market it anyhow.
Mr. Tonko. Thank you. Ms. White, you testified that the
current structure of Section 5 leaves EPA without the data it
needs to effectively evaluate chemicals and that the structure
creates a disincentive to producing that post data. Could you
please elaborate on that?
Ms. White. Absolutely. So EPA right now is not able to
require testing before a chemical goes on the market. If the
industry has tests, it is supposed to disclose them. But in
order to request more information, it has to find two things.
That one, there is an unreasonable risk of injury, or two, that
the chemical is going to be manufactured in such a high volume
that there would be a significant human exposure. So what
happens is, there is this chemical Catch-22, which EPA has to
try to figure out that there may be a risk, but it can't
require testing until it has evaluated testing. So it is this
really difficult cycle. It is like grading students without
actually asking them to take a test. So for example, I will
just give you an A because I know that maybe your son was a
really good student and maybe you are a neighbor of so-and-so,
but I am not actually requiring you to take any tests. So it is
a very difficult situation that EPA is in.
Mr. Tonko. EPA can't thoroughly review new chemicals for
potential health effects if it doesn't have adequate data to do
so. One policy that has been discussed over the years is the
concept of requiring a certain minimum amount, minimal amount
of data prior to a new chemical being brought onto the market.
What do you think of this approach? Does it have merit?
Ms. White. It absolutely has merit, and frankly, I think
most Americans assume that that is already in place. They are
very surprised to find out that EPA doesn't require a series of
tests before chemicals go on the market, so that is absolutely
where we should be heading, and that is where we should be
targeting reform for Section 5.
Mr. Tonko. And Dr. Lohmann, your thinking on the data
requirement?
Mr. Lohmann. I certainly agree, and that is--most global
players who deliver to the European market have to provide this
kind of data now to get onto the European market, get
reevaluated, or reassessed, reauthorized for their chemicals.
So the best thing the U.S. should do is find an agreement with
the European program to use the dossiers that are provided
anyhow, and they will all have to provide data. If you have no
data on your chemicals, there is no market in the EU. It seems
a very logical approach.
Mr. Tonko. Mr. Morrison, it seems to me that building
safety into the developmental process earlier is likely to be a
better approach to product development. This is the idea, I
believe, behind the green chemistry movement. Would you agree
with that in concept?
Mr. Morrison. Well, I think there is a basic underlying
assumption in your comment, which is we don't build safety, and
I think we do extensive testing. We have the greatest to lose
if we put products on the market that are hazardous, that hurt
health, that hurt environmental, et cetera, so we do extensive
testing when we develop new products. All of that information
is turned over to the EPA. They have very extensive databases
that they run and they run on analogous materials. And so I
think the underlying assumption that if the EPA doesn't force
the test it isn't done, they don't have to force the test in
many cases because it is already being done by us.
As far as green, we fully support green where appropriate.
Our company and many in the industry aggressively push it, but
it is one form of innovation. It is not the only form of
innovation.
Mr. Tonko. Is there any chance for added safety by
requiring the submission of a basic safety data set as part of
the initial pre-market review process?
Mr. Morrison. I actually think it would have an adverse
effect, because what you have to take into account is the
workload you would put on companies and EPA, you would take the
higher hazardous and now be swamped with all chemicals there
when there are much more effective and efficient ways to deal
with the vast majority. And so you are creating an unneeded
workload, which I believe would add very little or no benefit
and would, in fact, just swamp the EPA and they wouldn't be
able to prioritize their resources. It would also kill
innovation. The reason we produce three times more chemical
innovation than Europe, Japan, and others is because I think
our process works very effectively.
Mr. Tonko. I guess I am also hearing that they might
require more resources for EPA also to develop that plan, but I
believe I have extended my amount of time, so--exhausted my
amount of time, so I will yield back.
Mr. Gingrey. Thank the gentleman, and we now turn to the
gentleman from West Virginia, Mr. McKinley, for 5 minutes.
Mr. McKinley. Ms. White, I want to see whether I heard it
properly. Did I hear you say that often products going to the
market are not confirmed prior to going to market for toxicity?
Ms. White. That is correct. According to EPA, 85 percent of
the pre-manufacture notice, this approval process for
chemicals, do not have toxicity data. They have not submitted
that to EPA.
Mr. McKinley. Are you contending, then, that--are you
suggesting that they are trying to circumvent something by
doing that?
Ms. White. I am suggesting that the system is broken. There
actually isn't incentive for testing. There is an incentive not
to test because if you don't----
Mr. McKinley. You think that they are testing themselves?
Ms. White. If they are, they are required to give that to
EPA.
Mr. McKinley. OK, thank you.
Ms. White. But in 85 percent of instances, they don't.
Mr. McKinley. The other three panelists, can you respond to
that? I thought that was an interesting comment. I guess I did
hear that properly. Do you want to respond back to the going to
market without testing for toxicity?
Mr. Morrison. You know, where appropriate and data is
required, we of course test for toxicity and the idea that we
would put out products where we thought there was a risk simply
for economic reasons, first of all, it doesn't make any
economic sense because the risks would overwhelm any sales
potential. B, we apply the tests that are appropriate but we
don't blindly apply all tests to everything. It is not
economically viable, either. So I think the underlying
assumption is one I don't agree with.
Mr. McKinley. Mr. Sauers?
Mr. Sauers. And I think we have to distinguish between the
EPA's ability to do an evaluation of a chemical, and then the
toxicity data that is being mentioned here. You can evaluate
the safety of a material without having animal toxicity data.
There are other avenues available to you. The EPA has it its
disposal, you know, a vast database of animal data on
historical chemicals and they are experts in applying structure
activity to the relationships and productive modeling type
systems to evaluate the safety of materials. So just because
they don't get new animal testing data on a chemical that is
coming in does not mean that they don't have an ability to
evaluate that chemical for safety.
Mr. McKinley. Thank you. Mr. Isaacs?
Mr. Isaacs. Yes, sir. We actually think there would be a
benefit to improved tools and better predictive modeling at the
agency, and we also think that increased access and
transparency to existing data that is out there would benefit
the system as a whole. I understand that EPA is making some
efforts in that direction and we look forward to seeing the
results of that.
Mr. McKinley. Thank you for your responses back on that. I
am just curious, the fact that apple juice has arsenic traces,
arsenic in it. Should we be banning the drinking of apple juice
in America because there is a trace level of toxicity in that
material? Ms. White?
Ms. White. We would not say we need to ban apple juice, but
certainly a cause for concern when we have all these situations
where these low doses of chemicals--and arsenic is a different
situation--but when we are talking about chemicals that are
manufactured and not required to be tested before they go on
the market, that is shocking for most Americans.
Mr. McKinley. Ms. White, I just think I am with you more
than you realize, but I am also wondering how often we get to
maybe hysteria levels on some things. When we are burning coal,
we have the issue of toxicity that people use exaggerated
numbers and fears that are unwarranted and it puts the fear in
the minds of people, and the same thing. So I really do
appreciate the responses that we have had here today. If people
are going to market without checking for toxicity, whether it
is internal or through the agency, I think we need to determine
that but it sure sounds like the companies are doing the job
themselves, it appears, and I would hope that we wouldn't be
putting out false concerns to the public if they are out there
on that.
So with that, thank you and I yield back the balance of my
time.
Mr. Gingrey. Thank the gentleman, and I turn to the
gentleman from California, Mr. McNerney, for 5 minutes.
Mr. McNerney. Thank you, Mr. Chairman. I thank the
witnesses this morning.
I think it is pretty clear there is a conflict between the
industry's legitimate wish to keep trade secrets confidential,
and on the other hand, the risk of releasing chemicals whose
long-term and low exposure health impacts may not be very well
understood, especially when they are put in an environment
where they are going to be mixed with other very complex
chemicals. So everyone understands that it is in the industry's
interest to have consumer safety and consumer confidence. There
is no problem there. It is our duty, it is our job as a
committee, as a subcommittee, to try and resolve that conflict.
We are going to do the best we can and I appreciate your
participating this morning.
Mr. Sauers, I think I heard you say that an update of TSCA
is urgently needed. One of the reasons is to give consumers
confidence in the process, and I think that is pretty well
agreed to. But then you said later that the EPA's recent
decision to disclose specific confidential information is
hurtful. So I see that that is a little bit of a conflict in my
mind between wanting to improve consumer confidence and yet
thinking the EPA's decisions are problematic.
Mr. Sauers. Sure, and maybe just to clarify, we just had a
discussion about questions being raised about trace levels of
arsenic, for example, in apple juice. That does raise concern
to consumers' minds about the safety of products that are in
the marketplace. Many times a company like Procter and Gamble
doesn't have all the credibility as it communicates to
consumers about safety. The EPA does, so having and EPA with a
very robust system in place that is recognized will give a
credibility when they say that materials are safe, and we would
support that very much. We think that they do have the tools
today to do that with the information that is provided as part
of the PMN process.
Mr. McNerney. Well I will just suggest that, you know,
implying that EPA's new rules to release the information might
actually help in terms of the company's long-term credibility,
so that is my two bits on that.
Mr. Lohmann, you mentioned that one of the things we should
do is ID and replace the most dangerous chemicals, including
grandfathered chemicals. How big of a job would that be?
Mr. Lohmann. It would certainly be a major undertaking, but
luckily, the Europeans are doing that now anyhow, so they are
taking care of that and most global companies, like Procter and
Gamble, have filed all their dossiers so information on most of
those chemicals will be available. As I will also point out, it
will actually spur innovation towards safer chemicals so I
think it is a worthwhile endeavor.
Mr. McNerney. So it might spur innovation and profitability
then?
Mr. Lohmann. Because some of the comments we have already
brought, most right now in the environment were grandfathered
in. They had no testing. Some of the new ones we also worry
about, but certainly the grandfathered in are--should be
reassessed.
Mr. McNerney. Well one of the most striking things you said
was that there is a strong correlation between chemicals in
households and health problems that we are experiencing in our
country. Did you want to expand on that a little bit?
Mr. Lohmann. Certainly. I guess we can never know for sure
because etymology is very difficult to do, but it is striking
that a lot of the results that we see from either controlled
tests or even in the field of animals to low doses are exactly
the health problems that we see in modern society. So I am not
saying that chemicals are the sole cause of all the problems,
but there is probably a correlation, and that should worry us.
Mr. McNerney. Mr. Lohmann and Ms. White, have you heard of
the term chemical trespass, and if so, would you describe what
you think that term means?
Ms. White. Yes, chemical trespass means there is unwanted
chemicals that are in your body and rather than trespassing on
someone's land, in fact, a chemical has trespassed into your
body. It is a developing concept in tort law, and there is
certainly a lot of concern. Our studies have shown that, in
fact, these chemicals that we find in consumer products like
lotions and stain removers and laundry detergents and nail
polish are actually building up in people's bodies, and as I
said in my testimony, also in newborn babies.
Mr. McNerney. Would you, Ms. White, offer some specific
suggestions on how to improve the TSCA process?
Ms. White. Absolutely. With respect to the new chemicals
provision, we really need to make sure that the burden of proof
shifts from EPA to the manufacturers to show that their
products are safe before they go on the market. We also do need
a minimum data set so we know what the rule are, and so
consumers, we hear a lot about confidence. Consumers want to
know that when they have a nap mat, you know, where our
colleagues at the Center for Environmental Health released a
really great study that nap mats have flame retardants it is
really concerning. Parents want to know when their kids are
taking a nap at preschool that they aren't going to have a
chemical in their body, and that certainty would be really key.
Mr. McNerney. Mr. Lohmann, would you agree with that
response?
Mr. Lohmann. I would agree.
Mr. McNerney. I am sorry, I said Mr. Lohmann and I was
looking at Mr. Morrison. Mr. Morrison?
Mr. Morrison. Which element of a response, just to make
sure that----
Mr. McNerney. Well, if the--I will let my time expire on
that.
Mr. Johnson [presiding]. I thank the gentleman for
yielding, and Dr. Gingrey went to the floor, so I am going to
sit in for him. I am Congressman Bill Johnson from Ohio, and I
will take my 5 minutes now. I would like to thank the panel
for--you want me to go ahead? I was next until Dr. Cassidy
walked in.
OK, restart the clock. I would like to thank the panel for
being here. Thank you so much.
Mr. Sauers, since testing is not required when you first
file a Section 5 pre-manufacturing notice, does that mean you
have not tested that chemical?
Mr. Sauers. I think I will maybe answer by saying that
evaluations are made of the material and there are many ways of
making an evaluation of a chemical for safety. One way is to do
safety testing, you know, rodent test like an oral toxicity
test in rodents. There are also other ways to evaluate the
safety of a material, using tissue culture, using structure
activity relationships, predictive modeling, and things like
that. So materials are always evaluated. How they are evaluated
can be different, depending on the circumstance.
Mr. Johnson. Well, if you do testing before submitting a
PMN, do you assess a broad range of possible hazards?
Mr. Sauers. Yes, and it really would depend on the exposure
that one expects the material to have. So if it broad scale
exposure, you will find testing and evaluation across a variety
of toxicity end points. If it is specific for inhalation, it
will be different. If it is going to be a large volume exposure
versus a very small exposure, the degree of testing could be
different.
Mr. Johnson. OK. How standard is this practice within the
industry?
Mr. Sauers. I would say that most companies approach it the
same way, a risk-based approach of assessing exposure and
hazard. Most companies have toxicologists, like Procter and
Gamble, that will approach it this way.
Mr. Johnson. OK. Do you do additional tests on your own
after the PMN has been submitted?
Mr. Sauers. Generally by the time we have submitted the
PMN, the bulk of our testing is done because we are commencing
to manufacture and put the material in the marketplace, so we
want to have a full assurance of safety prior to that
happening. If in the course of marketing something comes
through our 800 line or through consumer comments that could
cause a question to be raised, we would go back and evaluate
it.
Mr. Johnson. OK. Mr. Morrison, do you agree with these
responses, consistent your----
Mr. Morrison. Yes, absolutely. You know, as an industry,
the chemical industry, we have a responsible care management
system that we share across all chemical companies that are
part of it, and that is the vast majority, and common best
practices are shared and employed, and I think we are very
consistent with Mr. Sauers' answers.
Mr. Johnson. OK. Do other forms of intellectual properties,
such as patents, provide adequate protection to confidential
chemical identities, in your view?
Mr. Sauers. Yes, they do provide some protection, but it is
not complete. There are very strict----
Mr. Johnson. Operative word was adequate, so do you
consider them to be adequate?
Mr. Sauers. Patents--for the purpose of patents and what
they cover, they are adequate.
Mr. Johnson. OK, Mr. Morrison?
Mr. Morrison. There is much confidential information that
is not covered by patents, and so while patents are effective
for the, you know, actual material that is under a patent, that
is fine, but there are many others that come under trade
secrets that are just as critical to our business and we don't
patent for very specific reasons.
Mr. Johnson. OK. Mr. Isaacs, Ms. White and Dr. Lohmann have
suggested that TSCA chemical review operate like reviews for
drugs by the Food and Drug Administration. What do you think
could be a reasonable reaction from your members if this were
to occur?
Mr. Isaacs. Well, of course I am not an expert in the drug
review process, but I think that would not be the right
approach. I think that would be--impose a time delay that would
impede the time to market that we require, but at the same
time, the key point that we would like to emphasize in all this
is the need for chemical assessments to be tailored to the
risks and exposure to the use in question. And we are confident
that in our industry, with the high degree of controls that we
impose on our processes, that the exposure and releases are
very, very low and the chemicals that we use are done safely
and responsibly.
Mr. Johnson. OK. Mr. Sauers, back to you. Doesn't Europe
require manufacturers to submit a minimum information set on
new chemicals?
Mr. Sauers. Yes, as part of REACH.
Mr. Johnson. OK, so if you are doing it in Europe, why not
do the same thing here in the United States?
Mr. Sauers. I think this is what we appreciate most about
TSCA is that the amount of data that is submitted is tailored
to the chemical and the exposure that individuals can expect
from it and its toxicity. You know, like Procter and Gamble, a
new chemical that is going into a laundry detergent, for
example, there will be vast exposure to that so that is
something you want to have a full, complete toxicity data set
on. And you can contrast that all the way back to maybe an
intermediate in manufacturing for which there is no exposure.
So really the amount of data needed for something like that is
minimal. So this ability to tailor the amount of information to
the need of the chemical to assure safety is really the best
approach.
Mr. Johnson. OK, thank you. Thank you all for your answers.
At this time, we will go to Mr. Barrow from Georgia.
Mr. Barrow. Thank you, Mr. Chairman. Something we have
talked a lot about is the over-classification of Confidential
Business Information problem here. We haven't talked much about
efforts to declassify stuff that is no longer necessary. Mr.
Morrison, in your written testimony, I think you talk about a
voluntary effort that is underway between the EPA and the
industry to try and declassify stuff that is no longer nor
needs to be confidential. Can you share--tell the committee
what that effort looks like?
Mr. Morrison. Yes, it is essentially with the EPA there is
an effort to identify what you might consider obsolete and
information that doesn't have to be classified anymore, and
actually working through a backlog of that and declassifying,
and it is one of the areas of opportunity that we think as the
new bill comes out hopefully that we can be more progressive
about and more effective with, both in classifying originally
on a CBI basis, but also declassifying.
Mr. Barrow. Building on that, and talking about conflicting
demands between the right to know between claims that everybody
has a right to know everything about this, and there is a
legitimate interest in keeping things confidential. I want to
shift just a little bit from competing demands about the right
to know, to a more pragmatic understanding about what we can do
to share information to folks who have need to know. For
example, Ms. White, in your testimony you talk about the needs
that some folks have, the legitimate needs of first responders
in emergency situations, and Mr. Morrison, you talk about
efforts to declassify stuff that no longer needs to be kept
confidential. Is there any kind of process that you all can
agree on that would sort of if not address completely to
everyone's satisfaction the issue of one's right to know would
still result in a practical dissemination of stuff to folks who
have a need to know? Is there some kind of process that we can
agree on that would move us forward in that direction? Mr.
Morrison, then you, Ms. White.
Mr. Morrison. There is actually a process in place now that
when an emergency situation happens, a spill, other type of
emergency situations for emergency responders, there is
information that is mandated, including material safety data
sheets, et cetera, which are very explicit and the up-front
section is all about emergency response to that particular
material.
So when you are in an emergency situation, either health or
environmental, the rules change automatically and we
disseminate information on it on an as-needed basis. So that is
already addressed, but we certainly look forward in the new
TSCA bill to see if there are any gaps that we can be more
effective.
Mr. Barrow. Ms. White, how would you address that subject?
Ms. White. I would say that we all basically want the same
thing. We want to make sure that chemicals are proved by a
trusted regulator and that the chemical industry is vibrant. I
think there is a lot of opportunity here for us to come up with
sunset provisions, for example, for Confidential Business
Information, also to make sure there is resubstantiation within
a certain amount of time. I think that there is an important
carve-out for medical personnel and emergency responders, and
there is a real opportunity for us to work together.
Mr. Barrow. Thanks. Mr. Sauers, it would be a poor dog who
won't wag his own tail, and since you won't do it, I will do it
for you. I have enjoyed my visit to P&G's facility in Augusta
back in 2010 and look forward to my next visit coming up in the
fall. Can you share with us anything about--you talk about the
importance of not creating disincentives for innovation in this
area. I know there are conflicting views about whether or not
total dissemination of everything is going to actually promote
innovation or not. What are the disincentives you would want to
avoid in a kind of revamp of TSCA?
Mr. Sauers. I would say that anything that would lead to a
loss of competitiveness, and I think this is where the CBI
comes in. I think that there is a balance that can be brought
between ensuring that everyone has the health and safety
information that they need to be able to make a conclusion on a
material, and the ability to protect competitiveness for
companies like Procter and Gamble. I think the process today
where the EPA is given full disclosure of all information, even
that which is confidential, enables them to make an assessment,
and then the public release of the health and safety
information with the generic descriptive form of the chemical
enables individuals to get an understanding and draw parallels
to other materials that are in the marketplace to ensure health
and safety. So I think there can be a balance that can be
brought there.
Mr. Barrow. I hope you all understand with votes pending on
the floor, no time left on the floor, I am going to yield the
rest of my time. Thank you so much. Thank you, Mr. Chairman.
Mr. Johnson. I thank the gentleman for yielding back. We
will go now to Dr. Cassidy from Louisiana.
Mr. Cassidy. Let me stress there is no time left to
increase my anxiety level. I apologize. I stepped out so if you
all addressed some of this, I have a question that is kind of
for across the board.
Dr. Lohmann mentioned that REACH in Europe is requiring a
lot of things that frankly I gather make some of your
proprietary information held by a government agency regarding
some of the testing, and I tried to Google it, and REACH is a
long, long PDF. I think your point, Dr. Lohmann, was that,
heck, this is already being required. It is just being required
by the Europeans and not by us. That is kind of an interesting
argument. What would you all say to that? Why don't we just do
what the Europeans are doing, because frankly, if they are
doing it, then your chain is only as strong as the weakest link
and the Europeans are kind of the weak link, perhaps, in some
of this, so to speak. Or maybe they are the strong link. But
how would you all respond to that?
Mr. Morrison. I mean, we operate under both REACH and the
EPA current guidelines, and we find REACH to be excessively
bureaucratic and we don't find it necessarily adds incremental
benefit. We think that the databases that the EPA has, the
analogous materials they work with, we can innovate faster
under the EPA system than we can as required under REACH.
Mr. Cassidy. Then let me ask, because each of you all is so
big. I kind of knew that you would be in the European market as
here, and that market is so large you can't ignore it. But do
you have a different product line, whether it is a U.S. market
versus a European market?
Mr. Morrison. In many cases, our products are modified on a
global basis by region, whether it is consumer or others, for a
wide variety of reasons, so sometimes there are very
significant differences.
Mr. Cassidy. OK, now they just told me I got to hustle, or
else there will be an attack out on me on my next campaign.
So Dr. Lohmann, next question for you. I looked up some of
your references. Now for example, eight weak estrogenic
chemicals combined at concentration below--produce significant
mixture effects. You mentioned this was in rats. What would be
required to produce--put it this way. It is hard to show a
negative. Now if we are going to establish safety and we had
rat data in which eight chemicals were combined to have an
effect, we don't know whether that would translate into humans,
and indeed, some of those effects might not be seen for
decades. So I guess my question would be the--at what point--
these guys could be tied up forever proving safety of
something, but you can't ever prove quite that something bad is
not going to happen. You see where I am going with this. What
would be the standard by which you could accept that something
was truly safe?
Mr. Lohmann. That is a very good question. I am not sure we
know the full answer right now, but I think being cautious is
helpful. Mix toxicity is the biggest unknown that everybody is
working on, because we know we are exposed to hundreds or
thousands of chemicals at the same time at trace levels, of
course.
Mr. Cassidy. And we don't know if those trace levels are
physiologically important, or pathophysiologically important.
It may be, but we don't know that.
Mr. Lohmann. That is correct, but we also know that
toxicity has become much, much more concerned about trace
levels over the time.
Mr. Cassidy. I absolutely can agree with that. Of course,
intuitively you know since EPA has been operating our
environment has become cleaner, and so if you will, there
should have been a higher toxicity exposure in times past than
now, and not for everything, but for many things.
Mr. Lohmann. That is correct. We certainly are cleaner with
respect to PCPs, but we certainly have increased in
perfluorinated compounds. We have more flame retardants, so it
is a give and take.
Mr. Cassidy. Yes.
Mr. Lohmann. I am not sure if we are much healthier that
way.
Mr. Cassidy. Much less mercury and much less lead. So I
guess--so I am not sure, it would always be a moving target. I
am sure we have now decreased lead, we are still seeing
something trace. How do we ever prove safety? If we are going
to establish safety beyond a doubt, will we ever have anything
established?
Mr. Lohmann. Well, one way to do this is to just wait and
see if the Europeans become healthier because of REACH and the
U.S. does not.
Mr. Cassidy. See, the problem is--and I read an article
that kind of critiqued this--was that there are so many secular
effects, and if you look at the effect of obesity, for example,
and the effects of it on breast cancer, it so much outweighs
the things that we know have an effect, alcohol, cigarettes,
family history, obesity are so powerful that even if there is
an effect of a trace element, then that effect might be drowned
out by the secular.
It is 33 seconds left. I am about to miss a vote. I have to
leave it there. Thank you very much.
Mr. Gingrey. Thank the gentleman, and we are going to
actually take a little break. We are waiting for Congressman
Green from Texas to return from that vote. He should be here
momentarily. I want to ask that all members have 5 days--ask
for unanimous consent, of course, that all members have 5 days
to submit opening statements for the record, that letters to
this subcommittee from 3M, the Cleaning Institute, and the
Consumer Specialty Products Association be included in the
record of this hearing, and that members have 10 days to submit
questions to the chair that will be forwarded to our witnesses
for their responses to be included in the record. Hearing no
objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Gingrey. I now yield to the gentleman from Texas for 5
minutes of questioning, Mr. Green.
Mr. Green. Again, thank you, and I know this panel knows we
have one vote on the House Floor and you will be seeing us come
in and out, although hopefully that vote won't take an hour,
only the typical 15 minutes. I appreciate the panel here. I
want to thank the majority for calling a number of hearings on
TSCA reform. I come from an area where TSCA reform is really
important. I have--in fact, I think Procter and Gamble is
probably the only company that doesn't have a plant in our
district that relates to chemicals. But we know we need to
reform and it needs to be done in a reasonable way, so that is
what we are hopefully the Bitter-Lautenberg bill or the draft
is something we can use on our side, on the House side, as a
guide.
Mr. Morrison, I am hoping you would share with our
subcommittee some of the end products that are a result of
chemicals manufactured by your company.
Mr. Morrison. Some of the end products would be wind energy
blades, solar panels--you are talking about end use markets?
Mr. Green. Yes.
Mr. Morrison. Medical applications in terms of devices we
go down into, we have more than 50 applications in automotive,
all wood products that you have touched probably use our
chemicals. We are in aircraft. We are extremely broad. We are
in electronics, so your cell phones, your iPads, we have
components and chemicals that go into all of that.
Mr. Green. One of the things we may need to look at as a
committee, that certain chemicals--we may have a higher
standard for baby bottles, for example, or for bottles of Diet
Coke or water or anything else, than we would for windmill
blades, or even automotive parts that we are not going to have
contact in. So you know, that is one of the things we need to
factor in on some of the issues.
Do you believe that chemicals developed by Momentive could
have developed under the regulatory regime of the European
Union?
Mr. Morrison. In some cases, yes, but in other cases, we
believe that the speed is not there, that it is a much more
bureaucratic system. It now requires a minimum data set. It
doesn't react as quickly, and so in some cases, we would not be
able to innovate at the same rate, and that is why the U.S.
innovates at approximately three times the rate of the European
Union on new chemicals.
Mr. Green. Well as a side, since we are talking about North
Atlantic Free Trade Agreement, you know, having common
standards as something we may need to deal with on a separate
venue and hopefully our committee will be able to deal with it
instead of just adopting whatever the European community does.
You have already given the answer about the regulatory regime
provided by the advantages of our competitive system. In your
testimony, you state that EPA and chemical manufacturers
developed a dialog over the years that benefits both the EPA
and the industry. Is that correct?
Mr. Morrison. Yes.
Mr. Green. Can you share how this dialog would help
industry develop new chemicals, particularly as it relates to
protecting human health and the environment?
Mr. Morrison. Yes. A lot of times, when the EPA puts out
guidelines, et cetera, dialogs back and forth, we self-regulate
in many cases as was described earlier where we will start down
a path developing something. If we find it has certain
characteristics that may not pass EPA muster or our own muster,
we will actually pull that product before it ever goes. Having
an ability to communicate back and forth with the EPA allows us
to proactively do that. It saves us the time from developing
something that won't hit the market, and it also saves the EPA
time. Conversely, I think because the process is quite
effective and it does lend towards innovation, it also allows
us to expedite things that will be successful and bring new
innovation quicker to the market than places like Europe.
Mr. Green. You noted in your testimony that EPA does not
require CBI claims to be justified. Is that correct?
Mr. Morrison. Yes.
Mr. Green. Do you think you could--we could still have the
innovation technology if EPA had the authority to say--of
course, we also are very proprietary interest, but do you think
if EPA had that authority you could still have the success you
are having?
Mr. Morrison. We like to believe that as far as
justification of CBI and the new Bitter-Lautenberg bill it
actually does change how CBI information is handled. That is
one of the modifications that might be an improvement to the
process today, and is something we could work with.
Mr. Green. Mr. Sauers, can you share two or three reasons
why you are opposed to requiring the industry provide a minimum
safety data on all new chemicals?
Mr. Sauers. It can be a waste of resources. As we approach
a new chemical, we understand the exposure, we understand the
safety testing or the safety evaluation that is needed. We can
tailor the program specifically to the needs of that chemical.
That is the approach that the EPA uses today as we go forward
with them in the PMN process. So this ability to tailor the
safety program to the specific needs of the chemical is very
important. You don't have that with a minimal set database.
Also, the decrease in animal testing that one gets with the
current EPA approach is very important. If you look at the
minimum data set, it is usually requiring tests like acute oral
toxicity tests. I am not sure who runs those tests anymore.
They are really not necessary to use animals to conduct such a
toxicity evaluation today. There are many other ways of
evaluating acute toxicity using structure activity
relationships. So a lot of testing will be generated that is
just not necessary as part of those minimum data sets.
Mr. Green. And I know the EU chemical regimen in your
testimony was lacking science-based chemical prioritization
process. It seems today because of CBI and with the advances in
reverse engineering is it is almost likely that there is no
real secrets that we can deal with, and would you agree that
having such a capacity that is readily available for chemicals
that should make it ineligible for CBI protection for the
industry?
Mr. Sauers. I would disagree with that. CBI is very, very
important for companies like Procter and Gamble to maintain
competitiveness. Now with that said, that does not mean that
information is held confidential to the point that it prevents
an agency from evaluating the safety of a material. You know,
there is no CBI for the EPA, for example. They get all the
information and then there is a generic-type form of the
chemical nomenclature that is released publicly with the health
and safety information so the public can make their own
evaluations.
Mr. Green. Mr. Chairman, I know you have been great with
the time. I have some other questions I will submit, but one of
them to Ms. White. I represent a very urban district. We have a
lot of chemical facilities, refineries in a very urban area. A
lot of ours--and we probably have the most monitored air-
monitored district in the country, with lots of different
levels from the State, our county, our city, and of course EPA
has some monitoring there, too. I have some questions I would
like to ask on how we can even do better. We want the jobs and
the industry, but we also want it to be done as safely as we
can.
Ms. White. Absolutely. Thank you, sir.
Mr. Green. Mr. Chairman, thank you for your courtesy.
Mr. Gingrey. Absolutely. I thank the gentleman from Texas.
The minority has asked unanimous consent to include a
letter from the Department of Toxic Substances Control from the
State of California to be included in the record, and without
objection, so ordered.
[The information appears at the conclusion of the hearing.]
Mr. Gingrey. I want to thank all of our five witnesses. I
think this has been an excellent hearing. I think all would
agree. We apologize for the interruptions, but believe me, if
you have been to other hearings you know that this is mild
compared to some of the interruptions that we have. And we got
through with everything we needed to cover, and I thank all of
our witnesses and without objection, the subcommittee is now
adjourned.
[Whereupon, at 11:28 a.m., the subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]
Prepared statement of Hon. Fred Upton
The Toxic Substances Control Act (TSCA) is one of the more
important and complex bodies of law in the jurisdiction of our
committee. It covers chemicals throughout their lifecycle,
starting even before they are first introduced into commerce.
TSCA deals with chemical testing, protection against imminent
hazards, worker exposure, and a host of other specific issues.
This subcommittee held a hearing last month to build a
foundation for members to understand TSCA from the point of
view of experts in the field, each of whom brought a unique
perspective on the law. We had a thoughtful dialogue between
members and witnesses--a valuable exchange that helped create a
foundation to broaden our perspective moving forward.
Today we follow up on that hearing by selecting two key
areas of the law to explore: regulation of new chemicals and
protection of proprietary business information. Both issues
have a direct effect on American innovation, which is crucial
to restoring our economy and creating job opportunities here at
home.
EPA cannot do the job we've given them to evaluate new
chemicals for introduction into commerce, or to evaluate new
uses of previously approved chemicals, unless chemical makers
provide EPA some specific and sensitive information about how
the chemical is made and how its developers expect to use it.
At the same time, EPA must be careful to not disclose that
information. Without information protection there is no
incentive to innovate. Without innovation, the economy can't
grow and we can't create new jobs.
Beyond protecting information, there are other issues with
new chemicals. For example, at our June hearing, one witness
commented that new chemicals are often safer and ``greener''
than the ones they replace. We all benefit when good, new
chemicals are cleared for market and ones that aren't ready are
held back.
Today we'll be asking our witnesses to help us better
understand specific chemical regulations under TSCA as they
tackle the following questions, among others:
How do TSCA regulations for new chemicals and new
uses and TSCA provisions on the protection of confidential
business information affect your ability to innovate?
Does EPA have the tools to make informed decisions
about new chemicals?
Is the protection provided to confidential
business information under TSCA appropriate?
Has TSCA implementation been consistent with the
original statutory purpose?
How do other countries treat new chemical
production and information protection?
Mr. Chairman, I welcome our witnesses and thank them for
helping us to better understand the interplay between EPA and
chemical developers.
# # #
----------
Prepared statement of Hon. Henry A. Waxman
Today the Committee continues to examine the Toxic
Substances Control Act (TSCA). TSCA is an important law because
of its role in protecting the American public from dangerous
chemicals--and it is long overdue for strengthening.
I understand that the Chairman intends to hold a series of
hearings to examine each of TSCA's sections in turn.
Today's hearing focuses on two sections of TSCA, section 5,
which provides for EPA's new chemicals program, and section 14,
which establishes protections for confidential business
information.
Both of these sections are in need of reform, and I welcome
the panel and their testimony. Today, we will learn that
section 5 has allowed chemicals onto the market that shouldn't
have been. And, we'll learn that section 14 has provided a veil
of secrecy for the chemical industry.
In recent years, EPA has undertaken a serious effort to
addresses the weaknesses in these and other sections. They have
audited thousands of confidential business information claims,
and have found that nearly 900 chemical identities that had
been claimed as confidential business information should have
been made publicly available. This information empowers
families, researchers, and consumer advocates who wish to
educate or understand the chemicals we are exposed to. But this
audit is resource intensive and is unlikely to be replicated
under today's funding levels.
That's why, over the years, everyone from the EPA
Administrator to the Society of Chemical Manufacturers and
Affiliates have agreed that unjustified claims of confidential
business information must be addressed.
EPA has also developed action plans for some of the most
dangerous and ubiquitous chemicals on the market. Some of these
dangerous chemicals were initially brought into production
under section 5 of TSCA. We now know that these chemicals pose
serious risks, butthose risks were not uncovered by the new
chemicals program. This is another area that is in vital need
of reform.
Four years ago, there was widespread agreement among
industry, labor, and nongovernmental organizations that TSCA
needs to be reformed. It's good that we are now turning back to
this issue.
Recently, there have been suggestions that a new
legislative proposal in the Senate will be the vehicle for us
to reform TSCA. But I have heard significant concerns about
that proposal from a variety of stakeholders, including federal
and state agencies, environmental and public health groups, and
other stakeholders. That is why this hearing and the future
ones to come are so important.
I want to thank the witnesses for appearing today, and I
look forward to hearing from them.
----------
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