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86–392 2014

REGULATION OF NEW CHEMICALS, PROTECTION 

OF CONFIDENTIAL BUSINESS INFORMATION, 

AND INNOVATION 

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 

(II) 

COMMITTEE ON ENERGY AND COMMERCE 

FRED UPTON, Michigan 

Chairman 

RALPH M. HALL, Texas 

JOE BARTON, Texas 

Chairman Emeritus 

ED WHITFIELD, Kentucky 

JOHN SHIMKUS, Illinois 

JOSEPH R. PITTS, Pennsylvania 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE ROGERS, Michigan 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

Vice Chairman 

PHIL GINGREY, Georgia 

STEVE SCALISE, Louisiana 

ROBERT E. LATTA, Ohio 

CATHY MCMORRIS RODGERS, Washington 

GREGG HARPER, Mississippi 

LEONARD LANCE, New Jersey 

BILL CASSIDY, Louisiana 

BRETT GUTHRIE, Kentucky 

PETE OLSON, Texas 

DAVID B. MCKINLEY, West Virginia 

CORY GARDNER, Colorado 

MIKE POMPEO, Kansas 

ADAM KINZINGER, Illinois 

H. MORGAN GRIFFITH, Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Missouri 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

Chairman Emeritus 

EDWARD J. MARKEY, Massachusetts 

FRANK PALLONE, JR., New Jersey 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

MICHAEL F. DOYLE, Pennsylvania 

JANICE D. SCHAKOWSKY, Illinois 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

DONNA M. CHRISTENSEN, Virgin Islands 

KATHY CASTOR, Florida 

JOHN P. SARBANES, Maryland 

JERRY MCNERNEY, California 

BRUCE L. BRALEY, Iowa 

PETER WELCH, Vermont 

BEN RAY LUJAN, New Mexico 

PAUL TONKO, New York 

(III) 

SUBCOMMITTEE ON ENVIRONMENT AND THE ECONOMY

JOHN SHIMKUS, Illinois 

Chairman 

PHIL GINGREY, Georgia 

Vice Chairman 

RALPH M. HALL, Texas 

ED WHITFIELD, Kentucky 

JOSEPH R. PITTS, Pennsylvania 

TIM MURPHY, Pennsylvania 

ROBERT E. LATTA, Ohio 

GREGG HARPER, Mississippi 

BILL CASSIDY, Louisiana 

DAVID B. MCKINLEY, West Virginia 

GUS M. BILIRAKIS, Florida 

BILL JOHNSON, Missouri 

JOE BARTON, Texas 

FRED UPTON, Michigan, ex officio 

PAUL TONKO, New York 

Ranking Member 

FRANK PALLONE, JR., New Jersey 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

LOIS CAPPS, California 

JERRY MCNERNEY, California 

JOHN D. DINGELL, Michigan 

JANICE D. SCHAKOWSKY, Illinois 

JOHN BARROW, Georgia 

DORIS O. MATSUI, California 

HENRY A. WAXMAN, California, ex officio 

(V) 

C O N T E N T S 

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

(1) 

REGULATION OF NEW CHEMICALS, PROTECTION OF CONFIDENTIAL BUSINESS INFORMATION, AND INNOVATION 

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. 

2 

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:] 

3 

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 naı ̈ve 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. 

4 

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 

5 

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 

6 

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 inVerDate Nov 24 2008 11:10 Feb 11, 2014 Jkt 037690 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-68 CHRIS
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dustry 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 

25 

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. 

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vest, 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 

50 

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 

66 

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 manuVerDate Nov 24 2008 11:10 Feb 11, 2014 Jkt 037690 PO 00000 Frm 00092 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-68 CHRIS
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facturing. 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, premanufacturing 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 

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ulatory 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? 

89 

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 

90 

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. 

91 

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? 

92 

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 Catch22, 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 

93 

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? 

94 

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 

95 

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. 

96 

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 

97 

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? 

98 

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 

99 

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? 

100 

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 

101 

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 

102 

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 BitterLautenberg 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 

103 

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 

104 

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 informaVerDate Nov 24 2008 11:10 Feb 11, 2014 Jkt 037690 PO 00000 Frm 00110 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-68 CHRIS
105 

tion. 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. 

106 

I want to thank the witnesses for appearing today, and I look forward to hearing 

from them. 

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86392.093
130 

DRIVING INNOVATION

How stronger laws help bring safer chemicals to market

&Y&DVUJW &4VNNBS Z

0 

5 

10 

15 

20 

25 

1972

1974

1976

1978

1980

1982

1984

1986

1988

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

Non-phthalate inventions 

Inventions that can use 

phthalates or non-phthalates 

1998: European 

Commission

SCTEE opinion and 

Recommendation

1999: Temporary EU 

phthalate directive 

2006: 

EU REACH 

Reg. 

Adopted

2008: 4 phthalates 

added to REACH 

Candidate List

number of patented inventions (as patent families)

Exponential growth in the number of 

patented inventions for phthalate alternatives 

beginning in 1999, coinciding with the adoption of stricter rules (as captured by the 

number of patent families for “non-phthalate” 

and “phthalate-free” inventions)

FIGURE 1

Spike in Patented Inventions Free of Hazardous Phthalates

Are innovation and the law at 

odds? A closer look shows 

that stronger laws for the 

management of hazardous 

chemicals help to drive innovation in 

chemical and product sectors. Innovation 

is especially relevant today as the US$ 4.1 

trillion (3.1 trillion euro) global chemical 

industry faces increasing pressure from 

consumers, retailers, and investors demanding safer products. At the same time, 

emerging economies are increasingly 

well-positioned to become leaders in 

chemical innovation, potentially leaving 

Western Europe and the United States 

behind. Together, all of these forces are 

instigating changes in how governments, 

chemical manufacturers, and downstream 

users of chemicals are working to ensure 

chemical safety and drive innovation. 

 The Center for International Environmental Law (CIEL) examined the impact 

of laws governing hazardous chemicals 

in terms of their effect on innovation.

Our Results

The prospect of stronger laws with regard to toxic chemicals sparked the invention, development, and adoption of 

alternatives. For example, in response to 

stronger laws to protect people and the 

environment from phthalates, a class of 

chemicals with hormone (endocrine) disrupting properties, our study of international patent filings shows acceleration 

in the invention of alternative chemicals 

and products. Spikes in the patenting of 

phthalate-alternatives clearly correlate with 

ing substances also illustrates how progressively stricter rules at the global level 

can drive a sustained effort to invent 

safer alternatives. 

 As innovation hinges on the adoption 

of inventions, stricter laws for hazardous 

chemicals can also IFMQ UPQVMMJOWFO

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studies highlight. Barriers exist that prevent the entry of safer alternatives. Overcoming the inertia of entrenched toxic 

chemicals typically requires the power of 

the government. Our findings show that 

stronger laws enable safer chemicals to 

overcome barriers to entry, such as economies of scale enjoyed by the current 

mix of chemicals, the externalization of 

costs, and the lack of information about 

chemicals and products on the market 

today. 

“Over-regulation...is seen as 

an old problem and there is a 

lot of truth in that. We are 

working to overcome it. But 

we also need to recognize that 

regulation can be a big driver 

of innovation.” 

— Peter Droell, Head of Innovation 

Unit, European Commission

the timing of new laws to protect people 

and wildlife from phthalates. As the stringency of measures increased, so too did 

the number of inventions disclosed in 

patent filings by the chemical industry. 

Similarly, the phase-out of ozone depletVerDate Nov 24 2008 11:10 Feb 11, 2014 Jkt 037690 PO 00000 Frm 00136 Fmt 6633 Sfmt 6633 F:\MY DOCS\HEARINGS 113\113-68 CHRIS

86392.173
131 

2 CIEL: DRIVING INNOVATION

Number of patented inventions by Eastman Chemical (formerly Kodak Eastman), Exxon Mobil 

and Dow Chemical from 1972–2010 for phthalate alternatives.

FIGURE 2

Stricter Laws Trigger Innovation by Major Chemical Manufacturers

0 

1 

2 

3 

4 

5 

6 

7 

8 

9 

1972

1974

1976

1978

1980

1982

1984

1986

1988

1990

1992

1994

1996

1998

2000

2002

2004

2006

2008

2010

Exxon Mobil 

Eastman 

Dow 

number of patented 

inventions (as patent families)

2006: REACH 

Adopted

1999: 

Temporary 

EU phthalate 

directive

In response to consumer concerns 

and advocacy campaigns, retailers 

and producers of consumer products are increasingly demanding 

other businesses in the value chain 

ensure that their products are free 

of hazardous chemicals.

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Addidas, H&M, Zara, and others 

recently announced plans to 

remove certain hazardous substances from their supply chain 

by 2015 or 2020, depending 

on the chemical. Among hazardous chemicals tested and 

found in garments were phthalates, nonylphenol ethoxylates 

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from most of its adult toiletries and cosmetic products. 

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and at the global level. For example, during a U.S. Senate hearing on the need for 

stricter laws in the United States, a major chemical formulator, stated: “We believe 

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developments . . . and that our government be a global leader in chemical 

regulatory policy.” 

 Thus, businesses recognize that consumer demand alone is generally insufficient 

and government action may be required to enable safer alternatives to enter and 

compete on a level playing field, both at home and abroad. 

BOX 1

Demand for Safer Chemicals

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1. Ensure the burden of proving 

chemical safety falls on chemical 

manufacturers

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2. Phase-out chemicals with 

certain intrinsic hazards

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3. Recognize endocrine disruption 

as an intrinsic hazard that cannot 

be soundly managed

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Claims of confidentiality 

should be justified, 

periodically re-justified, 

and never granted for health 

and safety information.


86392.174
132 

CIEL: DRIVING INNOVATION 3

“Stronger laws present 

an opportunity to prevent 

exposure to hazardous 

chemicals, while accelerating product innovation, 

job creation, and economic 

growth.” 

— Howard Williams, V.P. and 

General Manager of Construction 

Specialties, a multinational 

manufacturer of building materials

According to the European Commission’s interim evaluation 

of the impact of the EU’s REACH Regulation on innovation in 

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if not the, major driver for change at present.”

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have an impact on substitution as some chemicals may 

not be registered or produced at lower volumes, reducing 

supply—a “trigger” for innovation. Communication of 

information about hazardous chemicals along the supply 

chain made the strongest contribution to stimulating the 

conception of new products.

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information about its intrinsic properties, such as: whether it 

causes cancer, creates genetic mutations, negatively affects 

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or rises to an equivalent level of concern, such as endocrine 

disruption. 

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tion, and withdrawal. 

BOX 2

The REACH Candidate List: A Key Driver of Innovation

As more information is provided about the intrinsic hazards 

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stands to continue to drive innovation in the chemical industry. 

With broad criteria for indentifying endocrine disrupting 

chemicals and information about endocrine disrupting properties of chemicals, it stands to reason that the Candidate 

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4. Internalize the costs of 

hazardous chemicals 

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5. Promote access to information

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6. Craft stronger international 

laws to ensure a level playing field 

at the global level

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XPSME


86392.175
133 

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international law and institutions to protect the environment, promote human 

health, and ensure a just and sustainable society. 

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DRIVING INNOVATION

How stronger laws help bring safer chemicals to market

Are innovation and the law at odds? Our study finds that stricter rules over hazardous 

chemicals can not only drive innovation, but also create a safer marketplace. The study shows 

how stronger laws spur the innovation of safer alternatives and can pull safer alternatives 

into the market, enabling them to overcome barriers to entry. But, policies must be in 

place to ensure that alternatives do not also have intrinsic hazards, to better ensure that 

innovation leads to safer chemicals and products.

Read the full report to learn more about:

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to hazardous chemicals.

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alternatives into the marketplace.

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as a result of stronger laws.

t XIZJOWFTUPSTBOECVTJOFTTFTBSFJODSFBTJOHMZUVSOJOH

to green chemistry. 

Download the full report at 

IUUQDJFMPSH1VCMJDBUJPOT*OOPWBUJPO@$IFNJDBM@'FCQEG


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Æ 


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