U.S. GOVERNMENT PRINTING OFFICE

WASHINGTON : 

For sale by the Superintendent of Documents, U.S. Government Printing Office

Internet: bookstore.gpo.gov Phone: toll free (866) 512–1800; DC area (202) 512–1800

Fax: (202) 512–2104 Mail: Stop IDCC, Washington, DC 20402–0001

88–546 PDF 2014

TESTING OF CHEMICALS AND REPORTING AND 

RETENTION OF INFORMATION UNDER TSCA 

SECTIONS 4 AND 8 

HEARING 

BEFORE THE

SUBCOMMITTEE ON ENVIRONMENT AND THE 

ECONOMY 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED THIRTEENTH CONGRESS 

SECOND SESSION 

FEBRUARY 4, 2014 

Serial No. 113–114 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

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, Ohio 

BILLY LONG, Missouri 

RENEE L. ELLMERS, North Carolina 

HENRY A. WAXMAN, California 

Ranking Member 

JOHN D. DINGELL, Michigan 

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 

JOHN A. YARMUTH, Kentucky 

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, Ohio 

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) 

(II) 

(III) 

C O N T E N T S 

Page 

Hon. John Shimkus, a Representative in Congress from the State of Illinois, 

opening statement ................................................................................................ 1 

Prepared statement .......................................................................................... 2 

Hon. Paul Tonko, a Representative in Congress from the State of New York, 

opening statement ................................................................................................ 3 

Hon. Fred Upton, a Representative in Congress from the State of Michigan, 

opening statement ................................................................................................ 4 

Prepared statement .......................................................................................... 5 

Hon. Henry A. Waxman, a Representative in Congress from the State of 

California, opening statement ............................................................................. 6 

WITNESSES

Charles T. Drevna, President, American Fuel & Petrochemical Manufacturers .......................................................................................................................... 7

Prepared statement .......................................................................................... 10 

Robert A. Matthews, McKenna, Long & Aldridge, LLP, on Behalf of the 

Consumer Specialty Products Association ......................................................... 16 

Prepared statement .......................................................................................... 18 

Brent Grazman, Vice President, Quality Assurance, Viasystems Group, Inc., 

on Behalf of IPC—The Association Connecting Electronics Industries ........... 28 

Prepared statement .......................................................................................... 30 

Beth D. Bosley, President, Boron Specialties, on Behalf of the Society of 

Chemical Manufacturers and Affiliates ............................................................. 40 

Prepared statement .......................................................................................... 42 

Catherine Willett, Director, Regulatory Toxicology, Risk Assessment, and Alternatives, The Humane Society of the United States ...................................... 47 

Prepared statement .......................................................................................... 49 

Jennifer Sass, Senior Scientist, Natural Resources Defense Council ................. 63 

Prepared statement .......................................................................................... 65 

Jerome Paulson, Chairperson, Executive Committee of the Council on Environmental Health, American Academy of Pediatrics ........................................ 78 

Prepared statement .......................................................................................... 80 

(1) 

TESTING OF CHEMICALS AND REPORTING 

AND RETENTION OF INFORMATION UNDER 

TSCA SECTIONS 4 AND 8 

TUESDAY, FEBRUARY 4, 2014 

HOUSE OF REPRESENTATIVES, 

SUBCOMMITTEE ON ENVIRONMENT AND THE ECONOMY, 

COMMITTEE ON ENERGY AND COMMERCE, 

Washington, DC. 

The subcommittee met, pursuant to call, at 10:03 a.m., in room 

2123 of the Rayburn House Office Building, Hon. John Shimkus 

(chairman of the subcommittee) presiding. 

Members present: Representatives Shimkus, Pitts, Murphy, 

Latta, Harper, McKinley, Bilirakis, Johnson, Barton, Upton (ex 

officio), Tonko, Green, DeGette, McNerney, Schakowsky, Barrow, 

Matsui, and Waxman (ex officio). 

Staff present: Nick Abraham, Legislative Clerk; Gary Andres, 

Staff Director; Charlotte Baker, Press Secretary; Sean Bonyun, 

Communications Director; Jerry Couri, Senior Environmental Policy Advisor; David McCarthy, Chief Counsel, Environment and the 

Economy; Brandon Mooney, Professional Staff Member; Chris 

Sarley, Policy Coordinator, Environment and the Economy; Alison 

Cassady, Democratic Senior Professional Staff Member; Greg 

Dotson, Democratic Staff Director, Energy and the Environment; 

Caitlin Haberman, Democratic Policy Analyst; and Elizabeth Letter, Democratic Press Secretary. 

Mr. SHIMKUS. I would like to ask the committee to come to order. 

I will now also recognize myself for 5 minutes for the purpose of 

doing an opening statement. 

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

Today marks our fifth hearing in this Congress on the Toxic Substances Control Act. Our focus today is on two sections in TSCA 

dedicated to getting EPA relevant testing data and other information on chemical substances in United States commerce. Past application of Section 4 by the EPA to obtain information about existing 

chemicals has been frustrated by judicial interpretation. We need 

to push beyond re-litigating those cases and focus on what authorities the EPA has now, or could reasonably use in the future to 

produce tailored, necessarily, and high-quality test data, and other 

information to carry out TSCA. We will also pick up on the discussion from the last hearing on standards for data quality, and the 

use of the best available science. The goal is credible decisions 

2 

using high quality data. Information management will be one of 

the toughest areas to get right, but it is also one of the most important. 

I want to remind everyone that last summer former TSCA program director Charlie Auer testified before our committee that simply improving the way EPA is able to get information under Section 4 would have profound impact on improving TSCA’s overall operation. Let us not kid ourselves, though; information collection 

and analysis on thousands of chemicals will become time consuming and very expensive. EPA will have to be smart and efficient to make this program work, especially when it comes to using 

available information, particularly exposure history, in deciding 

whether more testing is needed, and who should do the testing. 

Today’s hearing will also focus on reporting for the thousands of 

chemicals in commerce. Section 8 requires the EPA to develop and 

maintain an inventory of all chemicals, or categories of chemicals, 

that are manufactured or processed in the United States. It also 

gives the EPA authority to require certain businesses involved with 

a chemical substance to maintain records and submit health and 

safety information report, particularly adverse health incidences 

caused by the chemical to the EPA. 

Within these reporting requirements, there are exemptions for 

polymers, microorganisms, and naturally occurring substances. We 

should find out if these make sense, and should be continued, and 

what the incremental gain, if any, in public health, resources, or 

protection occurs without these exemptions. We also need to focus 

on the definition of processor, and whether the definition is rightsized to the person’s activities and information EPA is receiving. 

With that, I want to welcome our witnesses and thank them for 

their expertise and candor. We expect them to provide a variety of 

perspectives on when testing should be required, and what we can 

do to improve testing techniques so we can speed up analysis and 

reduce use of animals in that testing. We look forward to their 

views. 

And before I yield to the ranking member, I want to go off script 

and also thank you. I think, in our questions and response, candor 

is going to be important. There is a lot of excitement in trying to 

move a bill, and move it properly. And the other thing is, I was 

going back into the records, and I think 1976 is when this was authorized and put into law, and I had just graduated high school at 

that time, and started my first year in college. So, suffice it to say 

that probably a review and update of this law is timely, but we 

have to do it right. A lot of you all here will help us muddle 

through that process, and point out the good, and the bad, the ugly, 

and maybe, working with my colleagues, we could find areas of 

compromise. 

[The prepared statement of Mr. Shimkus follows:] 

PREPARED STATEMENT OF HON. JOHN SHIMKUS

Today marks our fifth hearing in this Congress on the Toxic Substances Control 

Act. Our focus today is on the two sections in TSCA dedicated to getting EPA relevant testing data and other information on chemical substances in U.S. commerce. 

Past application of section 4 by EPA to obtain information about existing chemicals has been frustrated by judicial interpretation. We need to push beyond re-litigating those cases and focus on what authorities EPA has now or could reasonably 

3 

use in the future to produce tailored, necessary and high-quality test data and other 

information to carry out TSCA. 

We’ll also pick up the discussion from the last hearing on standards for data quality and the use of best available science. The goal is credible decisions using high 

quality data. Information management will be one of the toughest issue areas to get 

right, but it’s also one of the most important. 

I want to remind everyone that last summer former TSCA program director, 

Charlie Auer, testified before our committee that simply improving the way EPA is 

able to get information under Section 4 would have profound impacts on improving 

TSCA’s overall operation. 

Let’s not kid ourselves, though; information collection and analysis on thousands 

of chemicals will become time-consuming and expensive. EPA will have to be smart 

and efficient to make this program work—especially when it comes to using available information, particularly exposure history, in deciding whether more testing is 

needed and who should do the testing. 

Today’s hearing will also focus on reporting for the thousands of chemicals in commerce. Section 8 requires EPA to develop and maintain an inventory of all chemicals, or categories of chemicals that are manufactured or processed in the United 

States. It also gives EPA authority to require certain businesses involved with a 

chemical substance to maintain records and submit health and safety information 

reports, particularly adverse health incidences caused by the chemical, to EPA. 

Within these reporting requirements, there are exemptions for polymers, microorganisms, and naturally occurring substances. We should find out if these make 

sense and should be continued and what the incremental gain, if any, in public 

health resources and protection occurs without these exemptions. We also need to 

focus on the definition of processor and whether this definition is ‘‘right-sized’’ to 

the persons, activities, and information EPA is receiving. 

With that, I want to welcome our witnesses and thank them for their expertise 

and candor. We expect them to provide a variety of perspectives on when testing 

should be required and what we can do to improve testing techniques so we can 

speed up analysis and reduce use of animals in that testing. We look forward to 

their views. 

Mr. SHIMKUS. With that, I would like to yield to the ranking 

member of the subcommittee, Mr. Tonko, for 5 minutes. 

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

Mr. TONKO. Thank you, Mr. Chair, and good morning, and thank 

you for holding this hearing on the Toxic Substances Control Act, 

or TSCA. This is the subcommittee’s fifth hearing, as we have been 

told, on this program. The hearings have been very instructive, and 

are providing us with a good foundation from which to evaluate the 

current law, and to develop legislation to improve it. Reform of this 

legislation is long overdue. I hope, Mr. Chair, that we will be able 

to work together and find common ground in this effort, which I 

think is critically important. 

The two sections of TSCA we are focusing on today, Section 4, 

on chemical testing, and Section 8, on information reporting and 

retention, have not provided sufficient reliable information to support assessment and regulation of chemicals. The authorities provided to EPA in these sections are weak and cumbersome to implement. As a result, there is too little information gathered on the 

toxicity or environmental risks associated with chemicals, and the 

inventory of chemicals in commerce does not provide sufficiently 

detailed and contemporary data on the chemicals being used in the 

United States. Currently, the burden is on EPA to demonstrate 

that information is needed, rather than on industry to provide the 

information to demonstrate that their product has been adequately 

tested, and will present little risk when used properly. 

4 

The tragic situation in Charleston, West Virginia demonstrates 

several failings of our chemical safety laws. Not all aspects of this 

incident can be blamed on the faults with TSCA, but the lack of 

information needed to respond to this situation illustrates the failure of this law. When the water supply for the people of Charleston, West Virginia was contaminated with chemicals that leaked 

from a storage tank, there was little reliable information to provide 

the public, emergency responders, or to the water company to guide 

their response actions. As a result, there was public confusion and 

concern about the advice offered by public officials and the water 

company. There was little understanding of the fate of the chemical 

in the water supply, or what health or environmental effects might 

result from the spill. 

This illustrates the importance of having adequate information to 

inform decisions about the protection of human health and our environment. Reform of TSCA must result in better information, and 

clear authority for EPA to act. The agency must have sufficient information to evaluate the risks of chemicals currently on the market, and basic information should be available before we have an 

accident, not slapped together in the midst of a crisis. 

The agency must be able to assess the risk of new chemicals before they enter into commerce. Dr. Paulson informs us, in his testimony, that a substantial portion of chemicals are known to have 

a wide range of adverse, and most irreversible, effects on child 

health. That is a prime warning. So it is important that we move 

forward with a law that recognizes that fact, and offers adequate 

protections for everyone. 

I look forward to the testimony of our witnesses today, and I 

thank you all for being here to share your views on what is a very 

important topic. And, again, I thank you, Mr. Chair, and I yield 

back. 

Mr. SHIMKUS. I thank my colleague. Now the Chair recognizes 

the chairman of the full committee, Mr. Upton, for 5 minutes. 

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

Mr. UPTON. Well, thank you, Mr. Chairman. Today we are going 

to continue our examination of TSCA with a focus on the nuts and 

bolts of chemical information. For sure we want to develop a system for chemical regulation that is the gold standard for the rest 

of the world. It doesn’t mean the most precautionary, or the most 

commercially free-wheeling. It means a balanced system rooted in 

the best science and highest-quality information so that all of us 

can be confident that if a chemical is in our stream of commerce, 

it is safe, and commerce flows freely across State lines and across 

borders. 

The foundation of that confidence should be information, and 

that information must be grounded in rigorous science available for 

everyone to review, organized by category, and backed up by stateof-the-art testing when needed. The technology of testing has vastly 

advanced since 1976, and it will continue to evolve in a positive 

way. High power of computers will simulate and sort exposure date 

and analyze chemicals in batches by category so that time spent 

testing for biological effects, and the need to test on live organisms, 

5 

is, in fact, reduced. We have also got to make sure that we don’t 

go overboard and become obsessed with data collection for its own 

sake. There are thousands of chemicals in everyday life that are 

understood to pose no unreasonable risk when used as intended. 

We need to identify those based on information that we already 

have. Then we can focus our resources, information, development 

on the ones that we aren’t so sure about. It is often said that the 

job of the manager is to know when to stop taking data, and start 

making decisions. That is the challenge for EPA under a reformed 

TSCA. 

It is also the challenge that we on the committee face as we transition from our examination of current law to developing our own 

ideas for how to modernize, after nearly 4 decades, this body of regulation. So I look forward to working with every one of our committee members as we set out on that path. And I have every confidence in you, Mr. Shimkus, to chart a successful course to get this 

job done. Really, I do. And I also appreciate the leadership of Mr. 

Waxman, and Mr. Tonko, and every member of this subcommittee 

for the hard work that they have put in. 

We need to chart a path that, yes, not only will reach the House 

floor, but ultimately reach the President, and it needs to happen 

this year. All of us have stayed focused through these hearings and 

developed the policy expertise that will benefit each of us in our deliberations. It is hard work that attracts little publicity, but in the 

long run, our world is certainly going to be better for it. And I yield 

back. 

[The prepared statement of Mr. Upton follows:] 

PREPARED STATEMENT OF HON. FRED UPTON

Today we continue our examination of TSCA with a focus on the nuts and bolts 

of chemical information. We want to develop a system for chemical regulation that 

is the gold standard for the world. 

That doesn’t mean the most precautionary, or the most commercially free-wheeling. It means a balanced system rooted in the best science and highest quality information so we can all be confident that if the chemical is in our stream of commerce 

it is safe, and commerce flows freely across State lines and across borders. 

The foundation of that confidence should be information. And that information 

must be grounded in rigorous science, available for everyone to review, organized 

by category, and backed up by state-of-the art testing when needed. 

The technology of testing has vastly advanced since 1976 and it will continue to 

evolve. High power computers will simulate and sort exposure data and analyze 

chemicals in batches, by category, so that the time spent testing for biological effects 

and need to test on live organisms is reduced. 

We’ve also got to make sure we don’t go overboard and become obsessed with data 

collection for its own sake. There are thousands of chemicals in everyday life that 

are understood to pose no unreasonable risk when used as intended. We need to 

identify those, based on information we already have. Then we can focus our resources and information development on the ones we aren’t so sure about. 

It’s often said that the job of the manager is to know when to stop taking data 

and start making decisions. That’s the challenge for EPA under a reformed TSCA. 

It’s also the challenge we on the committee face as we transition from our examination of current law to developing our own ideas for how to modernize, after nearly four decades, this body of regulation. I look forward to working with all of our 

committee colleagues as we set out on that path. 

Thank you, Chairman Shimkus, Mr. Tonko, and all the subcommittee members 

for the hard work you’ve already put in. You’ve stayed focused through these hearings and developed the policy expertise that will benefit each of us in our deliberations. It’s hard work that attracts little publicity, but in the long run, our world will 

be better for it. 

6 

Mr. SHIMKUS. The gentleman yields back his time. I want to 

make sure I get that clip and send it to my spouse, so that she 

knows that I am working—— 

Mr. UPTON. And your high school science teacher. 

Mr. SHIMKUS. No, I don’t want to go there. Now, and this will 

be the first of many times that we get to recognize the ranking 

member, but, being the first one, I want to congratulate Henry on 

his announcement. I don’t expect him to go away quietly. I do expect involvement after Congress still with us and our issues. But, 

with that, let me yield 5 minutes to the ranking member and chairman emeritus, Mr. Waxman, for 5 minutes. 

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

Mr. WAXMAN. Thank you very much, Mr. Chairman. I am going 

to also give you a clip that you can share with your family, because 

I agree with Chairman Upton. This is a time for us to work together, and I want to work with you on reform of the Toxic Substances Control Act. I believe TSCA is a flawed law that must be 

updated, and we need to work together to do this. 

Last month, State and Federal officials in West Virginia were 

left scrambling when they could not find meaningful health and 

safety data on a chemical that had polluted the drinking water of 

300,000 people. This disaster illustrated some serious problems 

with the current law. New chemicals enter the market without 

basic toxicity data. Untested chemicals remain on the market, and 

chemical manufacturers often are not required to submit tests that 

they do to EPA. This is an area ripe for Congressional action, and 

holding a serious of hearing is a step in the right direction. 

But we also need to start bipartisan talks to see if we can reach 

a compromise that protects the public from dangerous toxic chemicals without unduly burdening industry. It is an open secret that 

the majority staff is drafting a TSCA bill, but at this point, they 

have shared nothing with the staff on our side of the aisle. They 

haven’t shown us language, or explained their concepts for TSCA 

reform. Of course, Mr. Chairman, this is your prerogative, but the 

reality is that an unbalanced proposal simply isn’t going to become 

law. 

The Senate also has drafted a proposal for TSCA reform. The 

chemical industry strongly supports it, but the public interest community is deeply concerned about the proposal. We need to 

strengthen TSCA, yet most environmental groups believe that the 

Senate draft would actually weaken the current law. This looks 

like a recipe for a stalemate, and we don’t need too many recipes 

for a stalemate. We get stalemates all the time without a recipe. 

If we are going to succeed, however, in reaching a compromise 

that will become law, we need a formulation that both sides, industry and environmentalists, can support, and I think there is a way 

we can achieve this. It is not commonly known, but in 2011 the 

American Chemistry Council, representing industry, and the Safer 

Chemicals Health Family Coalition, representing public health 

groups, sat down to see if they could find common ground on TSCA 

reform. They found many areas of agreement, and documented the 

7 

agreement in a memorandum prepared by the Meridian Institute. 

I believe this consensus between industry and public health groups 

could be a basis for productive discussions in this committee. 

Later today I will be sending a letter to these groups and requesting they share their results with our committee. And, Mr. 

Chairman, I would like to invite you to join me in sending this letter. The result of their careful policy discussions just might be a 

blueprint for success in our committee. 

In recent days I have been asked a lot about my views of Congress, particularly since I announced I am leaving. Now people 

want to know what I think about Congress. Well, I have said that 

although there are aspects of Congress today that I strongly dislike, I remain convinced that Congress can still be a powerful force 

for good for our Nation. I hope we can demonstrate that once again 

by working together on TSCA reform. Only when we work together 

do we see successful legislation all the way through to the President’s signature. That is what we need to do, initiate successful 

legislation in this committee, and see it all the way through. We 

have a history of that in our committee, and I hope we can go back 

to that pattern again. Thank you, Mr. Chairman. Yield back my 

time. 

Mr. SHIMKUS. Gentleman yields back his time. Now, again, the 

Chair, I would like to welcome you all here. You will all be given 

5 minutes for your opening statement. Your full statements will be 

recorded into the record. So we will start from left to right. We will 

start with Mr. Charles Drevna, President of the American Fuel and 

Petrochemical Manufacturers. You are recognized for 5 minutes. 

Welcome. 

STATEMENTS OF CHARLES T. DREVNA, PRESIDENT, AMERICAN FUEL & PETROCHEMICAL MANUFACTURERS; ROBERT 

A. MATTHEWS, MCKENNA, LONG & ALDRIDGE, LLP, ON BEHALF OF THE CONSUMER SPECIALTY PRODUCTS ASSOCIATION; BRENT GRAZMAN, VICE PRESIDENT, QUALITY ASSURANCE, VIASYSTEMS GROUP, INC., ON BEHALF OF IPC–THE 

ASSOCIATION CONNECTING ELECTRONICS INDUSTRIES; 

BETH D. BOSLEY, PRESIDENT, BORON SPECIALTIES, ON BEHALF OF THE SOCIETY OF CHEMICAL MANUFACTURERS 

AND AFFILIATES; CATHERINE WILLETT, DIRECTOR, REGULATORY TOXICOLOGY, RISK ASSESSMENT, AND ALTERNATIVES, THE HUMANE SOCIETY OF THE UNITED STATES; 

JENNIFER SASS, SENIOR SCIENTIST, NATURAL RESOURCES 

DEFENSE COUNCIL; AND JEROME PAULSON, CHAIRPERSON, 

EXECUTIVE COMMITTEE OF THE COUNCIL ON ENVIRONMENTAL HEALTH, AMERICAN ACADEMY OF PEDIATRICS 

STATEMENT OF CHARLES T. DREVNA 

Mr. DREVNA. Chairman Shimkus, Ranking Member Tonko, and 

Full Committee Chair Mr. Upton, and Mr. Waxman, members of 

the subcommittee, I am Charlie Drevna, President of American 

Fuel and Petrochemical Manufacturers. As the name implies, 

AFPM represents high tech manufacturers. While most people are 

familiar with the fuels they use every day, many are not familiar 

with the petrochemicals. Petrochemicals are the industrial building 

blocks that make the materials, ingredients, and processing agents 

8 

that appear throughout a variety of manufacturing supply chains. 

Whether it is the plastic casing of your cell phone, excuse me, the 

aspirin in your medicine chest, or even the helmet worn by a loved 

one in the military, petrochemicals, such as ethylene and propylene 

play a critical role in manufacturing, and in our lives every day. 

TSCA is a unique statute in that it has much to do with commerce and the manufacturing supply chain as it does with human 

health, and the environment. TSCA gives the EPA broad power to 

regulate chemicals in commerce. While AFPM supports rational 

modernization of TSCA, great care must be taken so that the manufacturing supply chains are not disrupted. This is one statute 

where our members believe that a strong Federal role is required 

to maintain the interstate flow of raw materials and goods. 

Since its enactment in 1976, we have learned that the implementation of TSCA has been challenging for EPA in certain areas, and 

there is still debate over whether the challenges have been due to 

the statute, or due to some of the choices the agency has made. I 

believe it is time to take a fresh look at how we control chemicals 

in commerce, and again try to strike that balance between helping 

the environment, and a globally competitive manufacturing supply 

chain. 

The U.S. is on the brink of a manufacturing renaissance, due in 

large part to dramatic reductions in the cost of energy and raw materials. Shale development has fostered the most globally competitive positioning for American manufacturers I have ever witnessed. 

Given this opportunity, when it comes to laws that affect the feed 

stocks driving the manufacturing renaissance, we must get TSCA 

modernization right. To begin, AFPM supports a bipartisan effort 

to modernize TSCA. That means a new starting point for discussion, and a constructive dialogue. I echo Mr. Waxman’s comments 

there. The current TSCA statute provides a solid backbone for 

chemical regulation, but AFPM does see room for improvement. 

One area for improvement is more guidance from Congress that 

directs the EPA to prioritize chemicals in commerce. AFPM views 

prioritization efforts under the Canadian chemical management 

program as a reasonable, achievable model. The approach used in 

Canada is a screening level look at chemical hazard and exposure 

to tell scientists whether or not more work is needed to deem a 

substance safe for its intended use, and the conditions of that use. 

Currently the EPA has sophisticated and protective models that it 

uses to evaluate the potential hazards of chemicals. The agency collects data under the chemical data reporting rule to determine the 

exposure potential of chemical substances. So there are no technical or practical reasons that EPA cannot prioritize chemicals for 

further work. 

Congress should also include provisions that increase scientific 

quality and transparency at the agency. Specific language should 

require EPA to develop criteria by which the agency and public can 

judge the quality of scientific studies under consideration, as well 

as EPA risk assessments. 

An important part of TSCA is Section 4, which authorizes the 

EPA to require laboratory testing of certain chemicals. I tend to 

agree that under Section 4, the prerequisite for EPA to find a risk 

posed by a chemical before it can require testing for that chemical 

9 

does not make sense. The exposure finding, on the other hand, is 

a built in check and balance to prevent EPA from demanding unreasonable animal intensive tests that will not lead to a further 

and better understanding of safety. AFPM firmly believes that 

there should be an exposure basis before EPA can require animal 

testing. 

AFPM’s highest level principles state that TSCA should be a 

tiered, targeted, and risk based approach. This is especially true for 

testing and data collection. A tiered approach begins with the use 

of existing information, protective models, and structure activity relationships. If there is an unreasonable amount of scientific uncertainty at a screening level, then the substance would be subject to 

the next tier, in which information is collected to reduce the uncertainty. 

When it comes to Section 8, which authorizes the EPA to collect 

information that provides an accurate reflection of chemicals to 

commerce, Congress should also provide specific guidance. For example, the chemical data reporting rule, EPA is required for producers to use exposure information. 

In closing, there are other sections of TSCA that may need updating, but I am confident that the subcommittee will address 

those issues at a later date. Thank you Mr. Chairman, Ranking 

Member Tonko, and subcommittee members for allowing us the opportunity to express our views. 

[The prepared statement of Mr. Drevna follows:] 

10 


88546.001
11 


88546.002
12 


88546.003
13 


88546.004
14 


88546.005
15 


88546.006
16 

Mr. SHIMKUS. Thank you, Mr. Drevna. Now the Chair recognizes 

Mr. Robert Matthews from McKenna, Long, and Aldridge, on behalf of the Consumer Specialty Products Association. Sir, you are 

recognized for 5 minutes. 

STATEMENT OF ROBERT A. MATTHEWS 

Mr. MATTHEWS. Thank you. Good morning, Mr. Chairman, Ranking Member Tonko, members of the committee. It is a pleasure and 

privilege to appear before this committee on behalf of the Consumer Specialty Products Association. It is our firm’s oldest client. 

We have been representing their interests for over 5 decades. So 

it is my privilege to appear on their behalf, and before your subcommittee. 

In fact, this year CSPA celebrates its 100-year anniversary serving as the premiere trade association representing the interests of 

companies both large and small. A good half of their companies are 

small businesses, the companies that formulate and market household and institutional products. 

In our written testimony, and in my comments today, we refer 

to our members as formulators, which is a segment of the downstream companies that are more generally referred to as processes. 

CSPA and its member companies have consistently advocated for 

the need to update the TSCA statute, and, importantly, recognize 

the role of downstream formulators in that process. CSPA’s role 

and interest in TSCA is to assure the process is working in a way 

that protects public health and the environment, allows companies 

to continue to operate effectively and efficiently in commerce, and 

maximizes consumer confidence in chemical safety, and by extension, in the branded products that we place on the market. 

CSPA’s support for modernizing TSCA is rooted in three principle considerations. First, it is critical, as I just mentioned, that 

consumers have confidence in these formulated products. Maintaining that high level of confidence in the safety of chemicals used in 

their products placed on the market is of utmost concern to CSPA 

and its member companies. 

Second, CSPA member companies who sell formulated household 

and institutional products increasingly face a multitude of State 

regulations, indeed, not only at the State, but at the local level, as 

legislative and regulatory entities are simply not waiting for Congress to act to modernize this statute. So we support modernization 

because it will create a more predictable environment in which 

companies can engage in interstate commerce. 

And, finally, among the reasons we have continually supported 

changes and modernization of TSCA is because our companies, like 

others in industry, are impacted by the adoption and globalization 

of the EU Reach program, with its focus on regulation by hazardous properties of chemicals, and its calls for massive data into 

the system that is often unnecessary, costly, and burdensome. We 

think this is an opportunity for the United States to assert its leadership in establishing risk based global chemical management programs. 

So I am now, with that background, pleased to share with you 

our very specific thoughts on how CSPA and its member companies 

can meaningfully participate in the TSCA statute that would 

17 

emerge after modernization. So we have focused in particular on 

the issues that impact our members. Those include in particular 

one that is before this committee today. That is Section 8, and the 

reporting provisions thereunder. We have also focused considerable 

attention on the confidential business information, or CBI, provisions of Section 14. So I will largely focus on Section 8, as this committee has requested, and the impact of that section on the 

prioritization program under Section 4. 

The key to a modernized TSCA is an affirmation of a risk based 

chemical management system, meaning that at the time that EPA 

is prioritizing chemicals for review, and setting standards, they are 

focused not only on the hazard, or intrinsic properties of that chemical, but the manner in which those chemicals are used, and the 

potential exposures that they create. 

But as it supports a risk based approach, CSPA has also recognized three related points. First, indeed, a risk based system starts 

with prioritization, where EPA screens chemicals in commerce to 

identify which ones should be subject to further review, and potentially to a safety assessment. Given the large number of chemicals 

in process, it is imperative that there be an effective screening 

process. Second, to properly screen, and indeed, again, potentially 

to conduct risk assessments, EPA must have information on how 

those chemicals are being used, and their potential exposure scenarios that they crate. And that leads to the third point, which is 

EPA has to have to have the means to get that information from 

where that information lies, which is principally with the downstream community, who know much more about use and exposure 

than do the raw material manufacturers. 

So the role of formulators under a revised TSCA, therefore, can 

be very much defined and targeted for that purpose. We have spent 

considerable time focusing on the elements that would be useful in 

that regard that would impact our member companies. So we have 

done so in a manner that aligns what we think is EPA’s needs at 

the prioritization stage with the information that we have. So we 

would propose to submit to the agency information that involves 

chemicals that will be placed in products, information on chemicals 

that are placed in products intended for use by children, information on the concentration range of the chemicals in those products, 

and, indeed, the number of workers, that is, who are involved in 

formulating those materials. Combined with the hazard materials, 

that is to say the hazard information, that EPA would have from 

the chemical producers, this would give EPA all that it needs in 

regard to prioritization. 

So I have much more to say about confidential business information. Perhaps that will come up, but that is the principle focus of 

our efforts, is to get that kind of use and exposure information into 

the agency. Thank you. 

[The prepared statement of Mr. Matthews follows:] 

18 


88546.007
19 


88546.008
20 


88546.009
21 


88546.010
22 


88546.011
23 


88546.012
24 


88546.013
25 


88546.014
26 


88546.015
27 


88546.016
28 

Mr. SHIMKUS. Thank you. Now the Chair recognizes Dr. Brent 

Grazman, Vice President for Quality Assurance, Viasystems Group, 

Incorporated, on behalf of the IPC, Association Connecting Electronics Industries, and more importantly from the St. Louis Metropolitan area, which is where I reside. So with that, welcome. You 

are recognized for 5 minutes. 

STATEMENT OF BRENT GRAZMAN 

Mr. GRAZMAN. Thank you, Mr. Chairman, and members of the 

committee for the opportunity address you today. Viasystems is a 

global manufacturer of printed circuit boards. We are 

headquartered, as the Chairman mentioned, in St. Louis. We employ over 2,000 people in the U.S. in eight different factories, including North Jackson, Ohio, and Littleton, Colorado. We make 

printed circuit boards that are used by leading manufacturers of 

transportation, telecommunications, medical, defense, and aerospace products. 

I am also here to represent IPC, the Association Connecting Electronics Industries. IPC is a global trade association representing 

over 2,000 electronics manufacturers in the U.S. As a member of 

IPC’s government relations committee, I want to emphasize that 

IPC and its members, including Viasystems, are all strong advocates for science-based regulation that improves the environment, 

protects human health, and stimulates the economy. In my testimony I will highlight our concerns about TSCA Section 8 as it applies to byproducts reporting. 

It is critical that Congress reform TSCA in a way that directs the 

Environmental Protection Agency to focus and prioritize its regulation of chemicals. Selection of priority chemicals should be based on 

sound science. Substances that exhibit the greatest hazard and impose the greatest exposure to consumers should be given priority 

for review for testing, and as needed for regulation. A targeted, 

prioritized approach will allow the EPA and industry to both more 

effectively use our limited resources to protect human health and 

the environment. 

An example of EPA’s failure to prioritize chemical regulation is 

the treatment of byproducts. Under TSCA, the EPA treats byproducts as new chemicals if they are sent for recycling. But if we sent 

them for disposal, there is no TSCA requirement invoked. As a new 

chemical, the byproduct sent for recycling must be listed on the 

TSCA inventory, and is subject to the full regiment of TSCA recordkeeping, reporting, and enforcement. Let me emphasize all of 

these regulatory obligations arise solely because a manufacturer, 

like Viasystems, sends a byproduct for recycling, rather than just 

disposing of it. 

TSCA contains specific exemptions for byproducts, but the EPA 

has narrowly interpreted these exemptions to apply only if the recycler does not use a chemical reaction to recover substances from 

the byproduct. Recovery of metals, like gold, tin, and copper, that 

are in our byproducts is impossible without the use of the chemical 

reaction. We manufacture printed circuit boards like this one. We 

don’t manufacture chemicals. 

The EPA requires us to know, at a molecular level, what the recyclers of our byproducts do with our byproducts. The recycler’s 

29 

processes are outside of our control. They are often proprietary, 

and they can change day to day, based on the market conditions 

that those recyclers see. The result is a regulatory policy that 

forces companies to report data based on incomplete information 

and assumptions, ultimately compromising the data quality. EPA’s 

overreaching interpretation affects a lot more facilities and companies than those represented by the IPC. Manufacturers from many 

industries are burdened by reporting their byproducts as new 

chemicals at the point when they send them for recycling. 

Much of the data that we repot about byproducts under TSCA is 

also required by the Resource Conservation and Recovery Act, and 

the Emergency Planning and Community Right to Know Act. 

Under TSCA, the recyclers are required to report the new chemicals they manufacture from our byproducts. The EPA unnecessarily 

burdens industry with the reporting of vast and duplicative data 

for some unknown future uses. 

As a Nation, we recognize reduce, reuse, and recycle as goals. 

The EPA undercuts those goals with regulatory policy that effectively discourages us from recycling. We encourage Congress to explicitly exempt all byproducts, including those that are sent for recycling. As I mentioned earlier, we manufacture printed circuit 

boards, not chemicals. The focus of TSCA, pardon me, should remain on ensuring the safety of chemicals in commerce. EPA’s authority to regulate articles, like printed circuit boards, should be 

limited to situations where regulating the chemicals themselves is 

not enough to protect human health and the environment. 

In conclusion, IPC supports cost effective, science based environmental regulation. As I have discussed, it is critical that Congress 

reform TSCA in a way that directs the EPA to focus and prioritize 

its regulation of chemicals. We believe that EPA’s reporting requirements for byproducts sent for recycling are burdensome, unnecessary, and, as I mentioned, they actually discourage recycling. 

Thank you again for this opportunity to appear before you. I will 

be happy to answer any questions when the time is right. 

[The prepared statement of Mr. Grazman follows:] 

30 


88546.017
31 


88546.018
32 


88546.019
33 


88546.020
34 


88546.021
35 


88546.022
36 


88546.023
37 


88546.024
38 


88546.025
39 


88546.026
40 

Mr. SHIMKUS. Thank you, sir. Now the Chair recognizes Dr. Beth 

Bosley, President, Boron Specialties, on behalf of the Society of 

Chemical Manufacturers and Affiliates. You are recognized for 5 

minutes. Welcome. 

STATEMENT OF BETH D. BOSLEY 

Ms. BOSLEY. Good morning, Chairman Shimkus, Ranking Member Tonko, and members of the subcommittee. I am pleased to testify—— 

Mr. SHIMKUS. Can you just pull that microphone just a little bit 

closer to you? 

Ms. BOSLEY. There we go. I am pleased to testify once again on 

behalf of the Society of Chemical Manufacturers and Affiliates regarding TSCA today on Section 4 and Section 8. Just a background 

on SOCMA, over 80 percent of our members are small businesses. 

For example, my business just hired its eighth employee. Even 

with that small staff, we are committed to responsibly manufacturing our products here in the United States. We produce unique 

chemicals by novel manufacturing techniques that are used in the 

electronics, aerospace, and nuclear energy sectors. 

SOCMA members’ unique niche in the chemical industry is 

known for its innovation, entrepreneurship, and customer focus. I 

would like to begin by saying that SOCMA remains committed to 

strengthening TSCA, and appreciates the subcommittee’s work in 

this aspect. 

We should avoid approaches to TSCA reform that would treat the 

vast universe of TSCA chemicals like the far narrower universes of 

food additives, drugs, and pesticides. In particular, the sheer number of new chemicals that are submitted to EPA each year, and the 

evolving market needs, mean that use by use approvals make sense 

for drugs and pesticides will not work for industrial chemicals in 

general. A TSCA reform bill should be fundamentally risk based, 

as you have heard from other witnesses at the table, and it should 

require EPA to look at a chemical’s inherent hazards, along with 

its exposures, when making regulatory decisions. 

An improved Section 4 should be tiered, targeted, and risk based. 

Generally stated, the real problem with TSCA has been the treatment of existing chemicals. Section 4 gives the EPA authority to require testing of existing chemical substances and mixtures once 

certain criteria are met. In this section, that allows EPA to obtain 

measured data on existing chemicals of currently available data 

and experience, are insufficient to reasonably predict their effects. 

The major shortcoming in this section is actually procedural. 

EPA is required to go through a rulemaking process, which has 

contributed to delays in EPA getting the data that they need. For 

example, EPA has taken years to finalize a number of high production volume chemical test rules, even though the industry has 

strongly supported such test rules. Voluntary efforts and enforceable consent agreements have helped streamline the testing process, but this section of TSCA could be strengthened by considering 

authorization for EPA to issue orders similar to the way it issues 

orders for new chemicals. 

Any orders for testing approaches should be tiered and targeted. 

That is, they should start off at a screening level, and focus the 

41 

testing where the risk is greatest. A screening level analysis may 

show that hazard is sufficiently low that additional test data will 

not be necessary. The same goes for scenarios where exposures are 

highly unlikely. We support the notion that EPA should have to 

abide by basic standards of scientific quality, and specify in accepting screening and testing data. We also believe alternatives to animal testing should be supported, where they are sufficient validated. 

The second major shortcoming of Section 4 is the lack of any requirement that EPA act on a specific number, or a percentage of 

existing chemicals, by any particular time. Congress should remove 

obstacles to more comprehensive EPA evaluation of inventory 

chemicals by mandating EPA to review a minimum number of 

chemicals annually via a risk-based prioritization process. We believe EPA has the expertise to do this. There are very talented scientist and engineers at EPA. Unfortunately, they don’t have the resources to do that at this time. Reforms to Section 8 could give 

EPA a better understanding of the exposure scenarios and able it 

to prioritize more efficiently. 

As mentioned above, testing of existing chemicals, should be 

tiered, targeted, and risk-based. Improvements to TSCA Section 8 

could help EPA determine whether an existing chemical warrants 

testing. One way Section 8 could be improved is by requiring an 

inventory reset to ensure that the inventory of existing chemicals 

is current. This effort will also pare down the initial number of 

chemicals to be evaluated. It is a concept we have supported for 

many years, and believe it is a vital first step to a robust and efficient existing chemicals policy. 

Another significant problem with Section 8 is that it does not authorize EPA to collect use or exposure information from anyone 

downstream of manufacturers or processors. The result is that, in 

many cases, manufacturers are forced to make educated guesses 

about the end use markets and exposure scenarios surrounding the 

use of their products. SOCMA would like to see an expansion of 

this section to allow collection of information from non-consumer 

downstream entities. 

Finally, we urge you to amend Section 8(e) to authorize manufacturers, processors, and commercial downstream distributers and 

users to file reports with the EPA regarding non-adverse findings 

about chemicals. Currently there is no mechanism to report such 

non-adverse date. The result is that the public database on existing 

chemicals is unnecessarily limited and biased toward the bad news. 

With reasonable amendments, TSCA could provide an easier mechanism to submit such information. 

As I conclude, it is important to mention that the LautenbergVitter Chemical Safety Improvement Act introduced into the Senate last year is a remarkable example of well-reasoned bipartisan 

TSCA legislation, and we endorse it as a vehicle for reform. The 

subcommittee should be able to leverage much of the work done 

there, including the work on Sections 4 and 8. Thanks for this opportunity. I will be happy to answer any questions. 

[The prepared statement of Ms. Bosley follows:] 

42 


88546.027
43 


88546.028
44 


88546.029
45 


88546.030
46 


88546.031
47 

Mr. SHIMKUS. Thank you. And before I go to Dr. Willett, we did 

have Senator Vitter and the new co-sponsor, Senator Udall, here 

for a hearing on this bill, and we applaud their work, and look forward to building on that. 

The chair now recognizes Dr. Catherine Willett, Director of Regulatory Toxicology Risk Assessment and Alternatives from The Humane Society of the United States of America. Welcome, and you 

are recognized for 5 minutes. 

STATEMENT OF CATHERINE WILLETT 

Ms. WILLETT. Thank you, Chairman Shimkus and Ranking Member—— 

Mr. SHIMKUS. Pull that mike just a little bit closer to you, because we want everyone to hear you. 

Ms. WILLETT. OK. Thank you. Thank you, Chairman Shimkus, 

and Ranking Member Tonko, for the opportunity to testify on behalf of The Humane Society of the United States, the Humane Society Legislative Fund, two members of the Nation’s largest animal 

protection organization. We strongly support animal protection, 

and also public health and environmental safety for the animals 

that are in our environment, and we believe that the Environmental Protection Agency should have the tools necessary to appropriately regulate chemicals in the United States. 

I am excited to be here to discuss the opportunities for 21st century science to impact Section 4 of the Toxic Substances Control 

Act. I have been a bench scientist for 20 years, and some of those 

years I was a practicing toxicologist. For the past 7 years I have 

worked internationally on chemicals policy. 

As mentioned by Chairman Upton, the science that underpins 

chemical characterization has undergone a radical transformation 

in recent years, as outlined in a 2007 report by the National Research Council, and which has also been taken up by EPA in their 

recent strategic plans. The report’s conclusion is that reduced reliance on whole animal testing leads to a more relevant and efficient 

toxicity testing paradigm, resulting in increased protection for humans and the environment. 

Rather than relying on a rote battery of animal tests, this new 

approach involves an iterative process of chemical characterization, 

toxicity testing, and extrapolation modeling, informed by population based data and human exposure information. This transformation is in response to challenges the EPA has experienced in 

obtaining data on the tens of thousands of chemicals to which people and the environment are potentially exposed, and in accommodating increasingly complex issues, for example, life stage susceptibility, the effect of mixtures, varying exposure scenarios, and cumulative risk. 

Any effective modification of TSCA must allow for, and encourage, adoption of these evolving strategies. By articulating this in 

any legislative proposal, Congress will also send a strong message 

that more effective chemical regulation is dependent on more effective, and humane, chemicals testing. To do this, we urge Congress 

to be mindful of the following considerations. As also mentioned by 

Chairman Upton, computational cell and tissue based methods can 

now be used to prioritized chemicals, or groups of chemicals, that 

48 

are of primary concern. These methods can also be used to satisfy 

information needs in some cases for some chemicals. Further development and application of these methods for use in risk assessment 

should be encouraged. 

Updated legislation should be flexible enough to allow the inclusion of new testing methods and strategies as they are developed. 

New legislation should provide EPA with significant commitment 

for creating the necessary infrastructure to do this. New legislation 

should also offer strong incentives for companies to fund, develop, 

and use new methods and testing strategies. And, as non-animal 

alternative methods become available, the use of such methods 

should be required in place of animal tests. We foresee a time when 

the principle of animal testing is a last resort. 

Protecting human health and the environment is a critical goal 

of effective chemicals regulation. In order to achieve this goal, it is 

necessary for any new legislation to allow and support the continuing evolution of the science of chemical assessment. The Humane Society of the United States hopes that we will have the opportunity to work with you on any legislative language to reauthorize aspects, or the entirety of TSCA. Thank you very much. 

[The prepared statement of Ms. Willett follows:] 

49 


88546.032
50 


88546.033
51 


88546.034
52 


88546.035
53 


88546.036
54 


88546.037
55 


88546.038
56 


88546.039
57 


88546.040
58 


88546.041
59 


88546.042
60 


88546.043
61 


88546.044
62 


88546.045
63 

Mr. SHIMKUS. Thank you. The Chair now recognizes Dr. Jennifer 

Sass, Senior Scientist, National Resources Defense Council. You 

are recognized for 5 minutes. Welcome. 

STATEMENT OF JENNIFER SASS 

Ms. SASS. Thank you very much, Chairman Shimkus, and Ranking Member—— 

Mr. SHIMKUS. Also, just pull that, there you go. 

Ms. SASS. Closer? OK. 

Mr. SHIMKUS. And if you can point the microphone to where your 

mouth is? 

Ms. SASS. Nobody ever complains about not hearing me, so I 

want—— 

Mr. SHIMKUS. Well, our transcribist was freaking out over there, 

so—— 

Ms. SASS [continuing]. It on record. Thank you for the invitation 

to be here, and to testify on this very important issue. As Mr. Waxman stated in his opening comments, TSCA is a statute that has 

failed to protect the public, and that is certainly true of its provisions regarding testing and data collection, which we are here to 

discuss today. TSCA needlessly impedes the collection of such information, with predictable results. 

In the wake of the recent spill in West Virginia, the impact of 

the information gaps in TSCA are more visible. The leaking of 4- 

methylcyclohexanemethanol, the MCHM, and other chemicals into 

the Elk River in West Virginia brought home, literally into peoples’ 

homes, the disturbing reality that no useful information is available to the public, or those who serve them. In fact, a Pugh Health 

Group research fact sheet put out in 2010 found that roughly 3,000 

chemicals used in over one million pounds annually in the U.S., 

these are the HPV, or high production volume chemicals, may have 

no information regarding potential developmental or pediatric toxicity. Nonetheless, over 700 of them are used in consumer products. 

CDC bio-monitoring has found over 200 synthetic chemicals in the 

blood and urine of Americans. 

TSCA provisions set an excessively high bar that has effectively 

prevented EPA from getting information. First EPA must essentially prove that a chemical poses an unreasonable risk to health 

or the environment before it can require the needed testing that 

would show a potential risk. This is like requiring a doctor to prove 

that a patient has cancer before being able to order a biopsy. It is 

a catch-22 construction of EPA’s testing authority that has greatly 

constrained the agency from getting data through testing in a timely manner. Second, to require testing of existing chemicals, EPA 

must complete a full formal rulemaking. Other programs, including 

the pesticide program, and even TSCA’s new chemical program, instead allow EPA to require testing by issuing an order, which is 

a much more streamlined process. 

As a result of these systems of hurdles and procedural hurdles, 

in the nearly 40 years since TSCA’s enactment, EPA has required 

a full set of testing data on only a few hundred of the 62,000 

grandfathered chemicals that came in under the law in 1976. The 

good news is that the flaws in Section 4 of TSCA can be resolved 

relatively easily by eliminating the catch-22 provisions of Section 

64 

4 and allowing the agency to require testing by order, rather than 

by rule, the bottleneck would largely be eliminated, and the agency 

would begin to get more information in a timely manner necessary 

to inform and protect the public. 

The failure of TSCA, and the subsequent action at the State level 

to collect information, and to limit the use of harmful chemicals, 

has prompted renewed discussion of TSCA reform, which is useful, 

but the Chemical Safety Improvement Act, S 1009, as introduced 

will not solve the problems with current TSCA, and in some respects, will make things worse. The introduced bill would prevent 

EPA from requiring testing for a chemical until it has already been 

identified as a high priority substance. This essentially replicates 

the existing catch-22. EPA would generally need evidence of hazard 

or exposure for a chemical to be designated high priority in the 

first place. Although EPA would be allowed to require testing for 

high priority chemicals by order, the universe of potential chemicals for which EPA could require testing would likely be greatly reduced. 

We also need more detailed use and exposure information for 

chemicals, as has been mentioned by other speakers, beyond what 

is currently captured in EPA’s chemical data reporting rule. Unfortunately, the chemical industry has routinely failed to provide updated production use and exposure data, and strenuously resisted 

government action to collect it. 

Various proposals have been made to reset the TSCA inventory 

as part of TSCA reform. If this is undertaken, Congress should not 

in any way delay efforts currently underway to take expedited action on substances, such as chemicals that are PBTs, the persistent 

bio-cumulative and toxic ones, or other chemicals for which we already have sufficient information to know that they are unsafe, or 

slow, for example, EPA’s current efforts to review its work plan 

chemicals. 

Second, if a substance is taken off the TSCA inventory, it should 

not be able to re-enter the inventory without going through a review process. A disturbing example is the firemaster 550, which 

ended up back in products, and in blood and breast milk. It is possible to have a balanced information regime that would protect the 

public, while helping industry by increasing public confidence in its 

products. The committee can play a critical role in this, and we are 

happy to work on that, but we are not there now. 

Thank you. 

[The prepared statement of Ms. Sass follows:] 

65 


88546.046
66 


88546.047
67 


88546.048
68 


88546.049
69 


88546.050
70 


88546.051
71 


88546.052
72 


88546.053
73 


88546.054
74 


88546.055
75 


88546.056
76 


88546.057
77 


88546.058
78 

Mr. SHIMKUS. Thank you. And last, but not least, we have Dr. 

Jerry Paulson, who is the chairperson of the Council on Environmental Health, Department of Federal Affairs, American Academy 

of Pediatrics. Sir, you are welcome, and you are recognized for 5 

minutes. 

STATEMENT OF JEROME PAULSON 

Mr. PAULSON. Good morning, Chairman Shimkus, and Ranking 

Member Tonko, and members of the subcommittee. Thank you for 

this opportunity to testify today about the testing and data collection requirements under the Toxic Substances Control Act of 1976. 

I am Dr. Jerome Paulson, and I am here representing the American Academy of Pediatrics, a non-profit professional organization 

of 60,000 pediatricians dedicated to the health, safety, and wellbeing of infants, children, and adolescents. As mentioned, I currently serve as the chair of the AEP’s council on environmental 

health. I will summarize my written statement, a full copy of which 

I have submitted for the record. 

Chemical management reform is an important policy that 

uniquely impacts children’s health. Children are not little adults. 

They have unique physiologic, behavioral, and developmental differences that amplify their exposure to chemicals in the environment. For example, infants may be exposed to contaminants in 

water used in formula preparation. Nobody else drinks formula. 

Toddlers engage in normal mouthing behaviors, where they put objects into their mouths, that may expose them to dangerous toxins. 

Children spend more time on the floor, or the ground, and come 

into more contact with contaminants on those surfaces. If we had 

kids in the hearing room today, they wouldn’t be sitting on chairs. 

U.S. Centers for Disease Control and Prevention researchers 

have found measurable levels of over 200 common industrial 

chemicals in body tissues and fluids of children of all ages, including cord blood. A number of hazardous chemicals also appear in 

breast milk. A substantial proportion, as Mr. Tonko mentioned, of 

chemicals known to have adverse, and mostly irreversible, effects 

on child health, such as lowering IQ, negative behavioral effects, 

and low birth weight, and reduced head circumference. 

The safety testing requirements under Section 4 of TSCA are inadequate to protect children’s health, and place too great a burden 

for safety testing on the public sector. Chemicals introduced into 

commerce when the law was enacted are subjected to scant oversight. For new chemicals, the process basically doesn’t work, and 

unless this legislation is reformed, with the tens of thousands of 

chemicals in need of review, and the multi-year process for each 

undertaking, it would require many decades just to review high 

production volume chemicals. These flaws limit EPA’s ability to 

protect the most vulnerable, including children and pregnant 

women, because the agency faces substantial barriers to obtain the 

information needed to make effective risk management decisions. 

Under Section 8, TSCA has created a non-evidence based system 

for chemical management. Concerns about chemicals are permitted 

to be kept from the public. In their notifications to EPA, chemical 

companies may declare large amounts of information to be confidential business information. This broad exemption has effectively 

79 

prevented the Environmental Protection Agency from sharing information about potential hazardous chemicals with community 

groups, local and State governments, and other organizations. Certainly an effective management system must include greater transparency than currently exists. 

Given the current urgent ongoing threat to children posed by 

chemical exposures, the American Academy of Pediatrics respectfully submits the following key recommendations for reforming the 

Toxic Substances Control Act. Under Section 4, manufacturers 

should be required to provide minimum data sets, with information 

that is relevant to the special needs of pregnant women and children regarding reproductive, developmental, neurodevelopmental 

toxicity, and endocrine disruption. Furthermore, EPA needs the 

flexibility to change data collection processes as new methodologies 

for testing become available. 

Under Section 4, the EPA should have a simple process to require additional testing when information suggests the need, especially for chemicals associated with child populations. The CDC’s 

bio-monitoring program must be expanded to serve as an early 

warning system for exposures. Aggregate and cumulative exposure 

concepts similar to those in the Food Quality Protection Act should 

be considered by EPA. Companies must develop public information 

documents for each new chemical marketed that utilizes lay language, and is updated regularly. 

In conclusion, strong chemical management policy must integrate 

evidence-based decision-making for chemical use to adequately protect children, and other vulnerable populations from harm. The 

American Academy of Pediatrics looks forward to working with you 

to advance sound and protective chemical management policy during the 113th Congress. And I will be happy to entertain questions. 

[The prepared statement of Mr. Paulson follows:] 

80 


88546.059
81 


88546.060
82 


88546.061
83 


88546.062
84 


88546.063
85 


88546.064
86 


88546.065
87 

Mr. SHIMKUS. Thank you very much. Now I would like to recognize myself for 5 minutes for the first round of, maybe the only 

round of, opening questions. 

So my first one goes to Mr. Drevna. Section 8 contains regulatory 

exemptions, as currently written. Some of these are for polymers 

and naturally occurring substances. Would you have concerns if a 

TSCA reform would invalidate those practices? 

Mr. DREVNA. Well, Mr. Chairman, I believe that Section 8 needs 

some reform, but I think there is a major misconception about, you 

know, what is out there, the 80,000 or so that some people say of 

chemicals that are out there, and really the 10,000 or so that are 

in commerce. So I think what Congress should do is direct the EPA 

to say, OK, this is what is out there, and what is out there has to 

be, as many of the witnesses have said, has to, you know, any regulation has to be tiered, targeted, and risk-based. 

I believe, from hearing most of the witnesses here, if not all, but 

I think we all agree on it. I think it is what the definition of that 

is, and what the ultimate goal of the modernization of TSCA should 

be. So I think if we can agree on what is out there, allow EPA to 

do a tiered, targeted, risk-based approach, we can all get to the end 

goal here. 

Mr. SHIMKUS. Thank you. Now, you know, we are not adversarial, so what I would like to do is try to get answers quickly. And 

it is a big panel, so this is for everyone on the panel, but for everyone to get through, please be as concise as possible. Does it make 

sense to have information quality standards for EPA to make decisions about chemicals? Mr. Drevna? 

Mr. DREVNA. It makes sense for EPA to have the authority to 

find out what is out there, and, again, do the tiered, targeted, riskbased approach, and have the authority to do the testing—— 

Mr. SHIMKUS. Quickly. 

Mr. DREVNA [continuing]. Get rid of Section 4, the risk assessment first. We agree to that. 

Mr. SHIMKUS. Mr. Matthews? 

Mr. MATTHEWS. It is always hard to argue with the notion that 

we should have quality standards in what EPA does. So, yes, we 

support EPA using the best available science and modern techniques. 

Mr. SHIMKUS. Mr. Grazman? 

Mr. GRAZMAN. Yes, sir, we agree with you too. 

Mr. SHIMKUS. Thank you. Dr. Bosley? 

Ms. BOSLEY. Yes, absolutely. Information quality is of utmost importance. 

Mr. SHIMKUS. Dr. Willett? 

Ms. WILLETT. Yes, and EPA and other regulatory agencies have 

some of these, but they might be improved. 

Mr. SHIMKUS. Dr. Sass? 

Ms. SASS. My concern about having them hardwired into the system, while I think everybody agrees in principle, I think the process that the agencies are taking now to develop those in a public 

and transparent way, with public comment, is the approach that 

should be taken. 

Mr. SHIMKUS. Dr. Paulson? 

88 

Mr. PAULSON. Quality standards are important, but I don’t think 

they should be in the legislation. The EPA needs the flexibility to 

change with time. And, as new technologies for chemical testing 

come on the market, they need to be able to respond to that. 

Mr. SHIMKUS. And my next question follows along on that response. Should different standards apply to testing? Mr. Drevna? 

Mr. DREVNA. Yes. 

Mr. SHIMKUS. Thank you. Mr. Matthews? 

Mr. MATTHEWS. Yes. 

Mr. SHIMKUS. Grazman? 

Mr. GRAZMAN. I have got to defer. We are manufacturers, 

not—— 

Mr. SHIMKUS. Right. Very good. Dr. Bosley? 

Ms. BOSLEY. Sure, should be based on risk. 

Mr. SHIMKUS. Dr. Willett? 

Ms. WILLETT. I am not sure I understand the question, I am 

sorry. 

Mr. SHIMKUS. Chemicals and processes are not all the same, so 

the question is should there be different standards applied, or 

should there be different standards to the level of risk-based chemical that might be out there? 

Ms. WILLETT. Yes, I believe that is true, but I think I may tend 

to agree that it might not be a legislative issue. 

Mr. SHIMKUS. Dr. Sass? 

Ms. SASS. I think your question is about whether we should treat 

chemicals differently depending not only on their hazard, but also 

on their exposure. And while I agree that there is some intelligence 

to that, the concern is that we have very little exposure information, so there is a practicality that is lacking. 

Mr. SHIMKUS. Thank you. Dr. Paulson? 

Mr. PAULSON. Mr. Shimkus, here again I think the EPA needs 

to have some flexibility. For example, had we only used hazard information on the chemical that was spilled in West Virginia, which 

was an industrial chemical, never intended for human exposure, 

other than the workers, then that chemical would not be reviewed. 

But, in retrospect, we are obviously in a situation where we wish 

it had been. So the EPA needs some flexibility. And we know, with 

the current law, the legislation has boxed them in in such ways 

that they can’t function. We should not repeat that. 

Mr. SHIMKUS. Thank you. I am going to take prerogative for a 

last question to Dr. Grazman. You raised in your opening statement this issue about how current TSCA law inhibits the ability 

to recycle. Many of us are very concerned about recycling. Mr. 

Green’s concerned about electronic recycling. Recycling is a good 

thing, not a bad thing. How does current TSCA law hurt recycling 

aspects? 

Mr. GRAZMAN. So if I took the byproducts from—— 

Mr. SHIMKUS. Pull the mike close. 

Mr. GRAZMAN. If we chose to just landfill, or get rid of the byproducts from our process, there is no TSCA obligation at all. When 

we choose to recycle, the TSCA obligations hit us in their full 

weight. So, all things being equal, sometimes it is easier not to recycle. 

89 

Mr. SHIMKUS. Thank you. We had that issue on ink and oil a 

couple Congresses ago, and the EPA kind of addressed it partially, 

but not fully, so that is an issue that we have raised in this committee before. 

Thank you very much. Now I turn to the ranking member, Mr. 

Tonko, for 5 minutes. 

Mr. TONKO. Thank you, Mr. Chair. This subcommittee has heard 

at previous hearings that EPA’s ability to require testing of new 

and existing chemicals under TSCA has been dangerously limited. 

TSCA requires any company planning to manufacture or import a 

new chemical substance to submit what is called a pre-manufacture 

notice. It is supposed to include information such as the chemical 

identity, use, anticipated production volume, exposure and release 

information, existing available test data. According to EPA, 85 percent of the pre-manufacture notices that agencies receive are accompanied by no toxicity data whatsoever. 

Dr. Sass, what kind of concerns does this raise for you? 

Ms. SASS. Well, not having any information at all means that 

EPA doesn’t know how to move forward. It means that EPA has 

very little power or ability to request that information. There are 

restraints and constraints put on EPA in order to move forward 

and collect that information. And I think it burdens the agency unnecessarily. I think the burden should be placed on the industry to 

provide the information that EPA needs to do risk assessment, but 

previous to that, do a proper hazard assessment. 

Mr. TONKO. Thank you. For existing chemicals, Section 4 of 

TSCA requires EPA to show that a chemical poses an unreasonable 

risk before requiring additional testing. Dr. Paulson, how has this 

requirement helped to undermine the law? 

Mr. PAULSON. This requirement basically has created the nonevidence based system that I referred to, and industry is basically 

penalized if they develop information in advance, because then they 

are required to report it to EPA, and that may adversely affect 

their bottom line. But with no reporting requirement, and then no 

ability to request information because you don’t know there might 

be a problem, EPA is totally stymied. 

Mr. TONKO. Thank you. With any reform, we must make sure 

EPA has adequate authority to require testing to protect human 

health and the environment. In the Senate there is a proposal to 

require EPA to categorize each chemical as either high priority or 

low priority. Under that proposal, EPA would be blocked from requiring testing on low priority substances. 

My question, Dr. Sass, would that proposal increase testing of 

the chemicals we are exposed to every day, or would it make the 

problem worse? 

Ms. SASS. I think it would make the problem worse. It would 

hamstring EPA. It adds an additional catch-22 to EPA, because it 

needs information to do an informed prioritization, and without 

that information, it may miss many chemicals that are very hazardous, and may be very important not only for hazard, but also 

for exposure. It would miss that information, and then it would not 

be allowed to go back and have the authority to review the low priority chemicals, and, furthermore, at the State level they may also 

be hampered. So those chemicals may actually slip through what 

90 

is not just a hole in the net, but really the whole net just doesn’t 

exist because of those chemicals being able to fall through. 

Mr. TONKO. OK. And, Dr. Paulson, what does the Academy of Pediatrics think about blocking EPA from requiring testing on these 

so-called low priority chemicals? 

Mr. PAULSON. Mr. Tonko, there does need to be a prioritization 

system for sure, but the EPA needs flexibility to move chemicals 

around, and any a priori blocking of chemical evaluation would 

imply that we would never learn anything. So if some miracle occurred, and new information came, the EPA couldn’t use that new 

information, so that just really makes no sense. We have waited 40 

years to modify this law. We should not create more barriers with 

a new law that will take another 40 years to improve. 

Mr. TONKO. Thank you. The recent West Virginia chemical spill 

has brought this debate to life in many ways. The chemical that 

spilled into the Elk River, spelled MCHM, was shrouded in mystery. State and Federal officials had to scramble to uncover the few 

health and safety tests that had been conducted on that chemical. 

Dr. Sass, how did the lack of health and safety data on MCHM 

hinder the CDC, and other officials, when responding to that chemical spill? 

Ms. SASS. The data for those chemicals didn’t come out for some 

time, and that created a concern, not only for public health officials 

at the State and local level, to be able to advise the community, 

and advise businesses about what to do, but also for the population 

as a whole, for citizens. The CDC was held back because it wasn’t 

able to do the kinds of calculations and evaluations that it needs 

to provide informed and timely advice to the community. And, also, 

health officials and first responders weren’t able to get information 

rapidly. They were having to advise and treat under a situation 

where they were essentially blindfolded because of that situation. 

Mr. TONKO. Thank you. I see my time is exhausted, so I yield 

back. 

Mr. SHIMKUS. The gentleman yields back his time. 

The Chair now recognizes the chairman emeritus, Mr. Barton, 

from the great Republic of Texas, for 5 minutes. 

Mr. BARTON. If only we were still a republic. You know, that is 

water under the bridge. Well, thank you, Mr. Chairman, and Ranking Member, for holding this hearing. I don’t have too many questions. My first question would be to Mr. Drevna, and you might not 

know the answer. Do you know how many chemicals right now are 

in the TSCA inventory? 

Mr. DREVNA. I am sorry, sir, I didn’t hear you. 

Mr. BARTON. Do you know how many chemicals right now are in 

the TSCA inventory? We talking hundreds of thousands, millions? 

Mr. DREVNA. Eighty to 100,000, I would imagine, if not more. 

Mr. BARTON. OK. Anybody dispute that? Do you know how many 

new ones are listed each year, approximately? 

Mr. DREVNA. I don’t know, 700,000? Not 700,000, 700 to 1,000, 

something like that. 

Mr. BARTON. OK. I know this whole hearing is on testing and 

disclosure, and then we have the issue of the animal testing, but 

other than that, is there any major controversy on how these new 

chemicals are tested? 

91 

Mr. DREVNA. I believe that the testing for new chemicals is pretty well established. Much as I criticize the EPA, they have done a 

nice job, in my understanding, doing the new—— 

Mr. BARTON. OK, let us go to the young lady. What is your dispute with what Mr. Drevna just said about the—— 

Ms. SASS. There is very little testing done on new chemicals, so 

EPA has issued some test rules, but it has been on a very few number of chemicals. EPA is restrained in a number of ways from 

issuing those test rules. There is timing on those. There are authority limitations for EPA. There is the requirement that it needs 

to actually find some hazard before it can issue new test rules, that 

catch-22 that several witnesses, including myself, mentioned. So, 

actually, it has been very ineffective. There has been very few 

chemicals that have been tested. 

Mr. BARTON. Now, is your complaint that the EPA has tended to 

engage in what we call a voluntary procedure, as opposed to the 

more complicated mandatory procedure? Is that a complaint, or—— 

Ms. SASS. Well, it is a complaint in where it hasn’t worked. So 

there have been a number of voluntary initiatives that have been 

larger, and there has been some information that has been gathered from those, but not very much. So I would say that they 

haven’t been effective overall, and there have been Congressional 

reviews that have shown that. 

But at the chemical by chemical level, so as chemicals are coming 

through the program, mostly, instead of EPA issuing test rules, because they are very cumbersome, and because they can be challenged, the EPA tends to negotiate with the company about what 

test rules it will issue. I am not opposed to that, so I am not complaining about that process, except where it has held back on EPA 

from being able to issue the kind of test rules that it needs to make 

a proper hazard evaluation. 

Mr. BARTON. Dr. Paulson, you raised your hand. 

Mr. PAULSON. I think that the voluntary programs have been ineffective. They have produced very little in the way of new information. The current legislation, and the judicial interpretation of that 

legislation, effectively block the EPA’s ability to ask companies for 

toxicologic information on the chemicals that they are introducing 

into the market. And that results in playing catch up, where years 

later individual scientists at universities do studies, and, lo and behold, we find chemicals in human bodies that were never intended 

to be in human bodies, and we find that those chemicals have adverse effects on those human bodies. There are just numerous examples of that. 

Mr. BARTON. Give me one example. 

Mr. PAULSON. Brominated flame retardants, perflorinated chemicals, of which Teflon is one brand name. Those are two examples. 

Mr. BARTON. And those chemicals were improperly tested, or improperly used, or illegally used? 

Mr. PAULSON. None of the above, sir. They weren’t adequately 

tested before they were marketed. They were used in ways that, 

presumably, industry thought was safe because they themselves 

did not have the data to indicate that they were getting into 

human bodies until later. And they didn’t have the data that they 

were harming human bodies until later. So I am not suggesting 

92 

any malfeasance here, it is just that, unless we develop the data 

before the chemicals come on the market, we are always subject to 

playing catch up. 

Mr. BARTON. My time did expire, and I want to thank the panel. 

Mr. SHIMKUS. I want to thank my colleague. I just want to just 

follow up real quick on one of the answers. It is my understanding 

the burden of proof is in Section 4, not Section 5, so we have got 

to be careful that we are conflating the authority under this law. 

That is why, going through this legislative process and our hearing 

is going to be very difficult, because we found that this language 

is very tough. So, with that, I would like to yield to my colleague, 

Mr. Green from Texas, for 5 minutes. 

Mr. GREEN. Thank you, Mr. Chairman, and I appreciate your interest in e-waste, and hopefully we can have a legislative hearing 

sometime so we can—— 

Mr. SHIMKUS. I am sorry, I am not hearing you. 

Mr. GREEN. I am sorry. I can’t imagine how hard it was in 1976 

for Congress to do TSCA, and that is probably why, for the last 38 

years, it hasn’t been revisited, because of the complexity of it. My 

first question is, before a company introduces something into a 

product, should there be some minimum level of due diligence? Because, Dr. Paulson, you talked about, the companies don’t know. 

Should there be some type of due diligence by that company, just 

to make sure that, both for the folks producing that product, but 

also for the consumers, that they should have that due diligence on 

the toxicity of that product? 

Mr. PAULSON. Yes, sir, that should be the basic function of any 

chemicals management policy, and we don’t have that now. 

Mr. GREEN. OK. We heard testimony today about how difficult 

it is for EPA to make the required findings to require the generation of additional information on chemicals under existing provision 

Section 4. What additional authority should EPA have to mandate 

the testing? Like you said, maybe we ought to say there is a requirement by a company to do some basic due diligence, and then 

EPA should have the authority to ask for that information? 

Mr. PAULSON. Companies should be required to release information to EPA. EPA should not have to ask for it. It should be part 

of the process before a chemical goes on the market that information goes to EPA. EPA is then able to evaluate that information, 

and make a decision. We also have to recognize that, even under 

the best of all possible circumstances, chemicals will receive approval that later turn out to be problematic, so EPA needs a mechanism to require companies to do post-market surveillance, provide 

the information on post-market surveillance—— 

Mr. GREEN. I understand that, and I have heard that, you know, 

in any given day or week, at least in the last 38 years, how many 

different chemical substances have been entered into the market? 

Now, somewhere along the way, you know, if we have literally 

thousands of companies, and for them to give that information to 

EPA, and then to empower EPA to then go forward, I agree that, 

you know, EPA should have the authority to request that information and those testing levels. But I am just wondering, you know, 

how big EPA would have to be to be able to deal with the complexities of the market now. And I know, from our manufacturers and 

93 

our specialty companies, it has got to be huge numbers of chemicals that are developed literally almost every day. Can you all just 

give us an idea on that? 

Ms. BOSLEY. Well, EPA looks at 20 chemicals a week, 20 new 

chemicals a week. That is their statistics. And beyond that, industry develops other chemicals that don’t go forward, certainly. But 

the resources EPA needs to look at new chemicals are very different than what they have been given to look at existing chemicals. They have no mandate, really, to look at existing chemicals, 

and, therefore, that is not where the resources are spent. 

Mr. GREEN. Well, and that is part of our concern. I want to make 

sure, you know, our lifestyle has been built over the use of these 

chemicals. And granted there are times, for example, in West Virginia that nobody knew about that chemical. Even the first responders didn’t know how to deal with it. So we need to deal with 

those, and that’s the job of our subcommittee, to come up with 

something that will do that. Drevna? 

Mr. DREVNA. Mr. Green, you are right. The thing about Section 

4, which we agree, to an extent, that the finding requirement 

should be eliminated, but the hazard requirement should stay. So, 

I mean, you could, in essence, limit the number of chemicals that 

have to be looked at if you grant EPA the authority for testing, but 

they have to still have a component of that that says, wait a 

minute, there is a need out there for an exposure and a hazard requirement. So that would go a long way to remedying the situation. 

And, I mean, there have been criticisms of TSCA because it inhibits the EPA from collecting information, but there are other 

statutes that come into play too. Administrative Procedures Act, 

things like that. So look at it holistically also. And, you are right, 

though, Mr. Green, we have got so many, you know, large volume 

chemicals that they are intermediates, that never really see the 

market. 

Mr. GREEN. And, Chairman, I know I am almost out of time, but 

also the low priority and high priority, obviously something that is 

exposed vulnerable populations, should be a higher priority even, 

you know, and so there is a way, I think we can draft this, but it 

is not going to be easy, any more than it was in 1976. So thank 

you, Mr. Chairman. 

Mr. SHIMKUS. The gentleman’s time has expired. The Chair now 

recognizes the gentleman from Pennsylvania, Mr. Murphy, for 5 

minutes. 

Mr. MURPHY. Thank you. I appreciate this panel. We are learning a lot from all of you here. Mr. Drevna and Mr. Matthews, I 

think, Dr. Grazman, you may have talked about this too, about this 

whole prioritization process, how it works. And I believe, Mr. 

Drevna, in your testimony you wrote that there was not 80,000 

chemicals, am I correct that was in yours, and there are really only 

about 10,000? How do we prioritize the safety of these in making 

some determinations? How do we set these rules up? All of our concern is that which is not forbidden is permitted, or that which is 

permitted is not forbidden, and we want to make sure we do this 

right. How would you recommend wording of this work? 

Mr. DREVNA. Well, I will go back to what I said earlier, Congressman Murphy, tiered, targeted, and risk-based. If you give EPA 

94 

the authority through statute to use that kind of mentality when 

addressing whatever chemical it is, whether it is a high volume 

chemical, or whether it is something that is, you know, a daily 

household product, if you do it tiered, targeted, and risk-based, and 

understand what, you know, what the hazards are, what the toxicity is, what the exposure is, and that will go a long way to giving 

EPA the right tools to address the situation. 

Mr. MURPHY. OK. Mr. Matthews, do you have anything to add? 

Mr. MATTHEWS. Well, I appreciate the doctor. 

Mr. MURPHY. We didn’t want to write ‘‘doctor.’’ 

Mr. MATTHEWS. Well, we agree, but let us be clear, the impression shouldn’t be formed that there isn’t substantial information on 

a lot of these chemicals that are in commerce, including existing 

chemicals, not just new chemicals. EPA has substantial information. It allows it to start to make some judgments about which are 

the chemicals that should be first put through a screening process, 

part of prioritization. What we have said is, they have substantial 

information, but they are missing a key component, and that is the 

use and exposure related information. So we think that EPA can 

do a proper screening process, even of the tens of thousands of 

chemicals that are already out in the marketplace. They need to do 

that. Make no mistake, this can’t be done overnight. The numbers 

we are talking about are substantial. But, in order to get to the 

right choices first, they need not only the information they have 

historically been receiving, but additional use and exposure information, and start the process of getting through these existing 

chemicals that have been on the market. 

Mr. MURPHY. Thank you. And, Dr. Bosley, can you explain the 

importance of how you protect the chemical identity of information 

that is submitted to EPA’s—— 

Ms. BOSLEY. Certainly. So we in the chemical industry, first and 

foremost, not one of us wants our chemical to cause harm to 

human health or the environment. By the same token, we live in 

the market reality, and we are faced with competitors every day. 

For instance, my company, very, very small. My competitors all 

know who I am. If I were to submit something to EPA with the 

chemical identity revealed, they would know immediately what sort 

of research I was doing, and, because my markets are so limited, 

they would know exactly where that end market would be. So it is 

not that I want to hide any hazard information that I have. I don’t. 

I want to send that all out, but I would like to keep my chemical 

ID confidential. As long as there is a robust generic name, such 

that the public, the NGOs, and the EPA can all see what the generic name, and what the hazard is. 

Mr. MURPHY. Thank you. Dr. Sass, I believe you, if I am correct, 

are recommending we adopt some of the standards the Reach program has in Europe. Do you think that would be more effective for 

us to do that? 

Ms. SASS. That wasn’t in my testimony. Is that your question? 

Mr. MURPHY. Yes, that is my question. Do you think that would 

be—— 

Ms. SASS. Do I think it would be more effective? Well, I do think 

it would be more effective to have harmonization, and the other 

speakers have also mentioned that. I mean, having a patchwork 

95 

approach across continents, across countries, across States, isn’t 

any good for anybody. And I do think that the approach we should 

use should be the highest bar to protect human health and the environment. I think that not only saves costs and liabilities for the 

produces, manufacturers, users, and retailers, but also insurers in 

the healthcare. So, I mean, the difference between having a cancer 

and treating it, and never having had the cancer in the first place 

is huge, not only on personal cost, but on economic cost. So I think 

everybody has an interest in preventing problems. I think everybody agrees to that. The difference is how we are going to address 

them, and at what stage we are going to address them. 

So I would support a system that would give the regulatory agencies the authorities not only to have early comprehensive and timely testing, but to make decisions on what they have. Some of the 

other speakers have mentioned, and I agree, that we have substantial data on a number of chemicals, and I think we can take action 

on those. 

Mr. MURPHY. I know we are almost out of time, but, Dr. Bosley, 

I would like you to submit also your responses to that, in terms of 

how the Reach requirements would contribute, being a big trade 

barrier for the United States. 

I am going to also add this too. I was recently meeting with a 

company in my district, Halgon Carbon. This little bottle of granulated activated carbon is what is used in many cases to clean up 

some of these chemical aspects. One gram of this, and there are 

about five grams in a pack of sugar, has more surface area than 

a football field. And I would hope that, as we are looking at these 

TSCA issues too, that we include in the whole package of analysis 

here not only what are the toxic levels in some of these chemicals, 

but also the cleanup process that would mitigate these things is a 

critically important part, by which we take a chemical of concern 

to a chemical of safety. 

And with that I yield back, Mr. Chairman. 

Mr. SHIMKUS. The gentleman yields back the time. The Chair 

now recognizes the ranking member of the full committee, Mr. 

Waxman, for 5 minutes. 

Mr. WAXMAN. Thank you, Mr. Chairman. A number of today’s 

witnesses have testified in support of a risk-based approach to 

chemical regulation, and I would like to explore this topic. 

Dr. Sass, I would like to see if you could help us understand 

what a risk-based approach means. To understand the risk a chemical poses, EPA would have to need information on both the hazard 

the chemical presents, as well as information about exposure. Can 

you tell us what information EPA would need to implement a riskbased system that the American people can have faith in? 

Ms. SASS. Well, sure. So EPA already does conduct risk assessments on chemicals, and that means that it has both how bad the 

chemical is, the hazard information, and what are the chances, or 

probabilities, that you are going to be exposed to it, the exposure 

information, and that is important. But, earlier than that, EPA has 

to be able to collect both those sets of information, and what this 

is trying to get at is hazard. It is important to separate those out, 

because later, when you make risk management decisions, they 

will take into account exposure as well. 

96 

But, at this stage, doing a hazard assessment, it is critical to 

focus on the hazard only. There are a number of reasons why. For 

one thing, we have more of that data than we do about exposure 

information. Exposure information is very, very expensive, and difficult to get. I wish that the chemical industry could give us the 

kind of exposure information that they have all testified that EPA 

should have. But it is—— 

Mr. WAXMAN. Well, without this information, we wouldn’t be able 

to understand the risk a chemical presents, is that what you are 

saying? 

Ms. SASS. That is right. Half the equation would be gone. We 

don’t have that information. 

Mr. WAXMAN. Dr. Paulson, do you agree? 

Mr. PAULSON. Yes, Mr. Waxman. 

Mr. WAXMAN. I would like to turn to Mr. Drevna. In your testimony, you suggested EPA should first make screening decisions. 

That is, EPA should determine whether a chemical should be a 

high priority or a low priority based on existing information about 

what you describe as ‘‘potential hazards and exposures’’. Are you 

recommending that EPA make decisions without having actual information about hazards and exposures? 

Mr. DREVNA. No, sir, not at all. We are recommending—— 

Mr. WAXMAN. Is your mike on there? 

Mr. DREVNA. Yes, it was. 

Mr. WAXMAN. OK. 

Mr. DREVNA. No, sir, not at all. We are recommending that, you 

know, you can adopt a system, like the Canadians have adopted, 

where you can have, you know, you rank chemicals, you understand the molecular structure to most of them, you know, and you 

can use current technologies to figure out, you know, rank them, 

do the exposures. We are recommending that EPA have the authority to ask for exposures under a new Section 8(a), you see in my 

testimony. Absolutely, no, we are recommending that—— 

Mr. WAXMAN. I appreciate that. So under the Senate proposal, 

the screening level decision would be a very important one, because 

once a chemical is designated as a low priority, the chemical is 

shielded from further study and review. Dr. Sass and Dr. Paulson, 

is there sufficient existing information in most cases for EPA to determine that chemicals are low priority, and shouldn’t be subject to 

any further scrutiny? 

Ms. SASS. No, that concerns me. Determining something is a low 

priority, or not hazard, should be a very high bar. For example, the 

International Agency for Research on Cancer under the World 

Health Organization has, I think, only one or two chemicals in that 

category. It should be a very high bar to actually put something 

aside and not look at it anymore from a public health and environmental protection perspective. 

Mr. WAXMAN. Is there sufficient information? 

Ms. SASS. Without sufficient information. 

Mr. WAXMAN. Dr. Paulson? 

Mr. PAULSON. No, sir. I think, particularly for new chemicals, by 

definition, there is not sufficient exposure information. 

Mr. WAXMAN. Um-hum. 

97 

Mr. PAULSON. And even for chemicals that have been around for 

a number of years, there may not be bio-monitoring methodologies 

that are available. There may not be methodologies for measuring 

those chemicals in soil, or other organisms besides humans. So, as 

Dr. Sass mentioned, exposure information is often extremely limited. 

Mr. WAXMAN. OK. Well, in Mr. Grazman’s testimony, he objects 

to EPA collecting certain information. For example, he objects to 

the collection of information about worker exposure. He also seems 

to object to reporting about the volume of each chemical that is 

manufactured, and the consumer and commercial uses of chemicals. Dr. Sass, this seems like important information for understanding exposure. Can EPA evaluate exposure, and therefore risk, 

if it doesn’t have information on how chemicals are used, and how 

exposure might occur? 

Ms. SASS. You know, Mr. Waxman, you are exactly right. EPA 

needs much more use and production, and also downstream use information, and it needs to be able to update that information in a 

timely manner as that chemical travels through commerce, and has 

different—— 

Mr. WAXMAN. If we want EPA to make good decisions, then that 

means we don’t want them guessing. That means you can’t have 

both a risk-based system, and an unwillingness to provide EPA 

with adequate information, is that your—— 

Ms. SASS. That is correct. I agree. 

Mr. WAXMAN. And Dr. Paulson, would you care to comment on 

this issue from a children’s health perspective? 

Mr. PAULSON. While adult workers obviously aren’t children, 

they are often sentinels, and we need to be able to gather information on worker exposure and use that information to help understand, perhaps, either gaps that we need to fill about children, or 

be able to extrapolate to children in the instances where you can. 

So just in that one narrow area that you are talking about, I certainly agree that blocking the EPA’s ability to collect and use that 

data will make it much more difficult to make decisions about 

chemicals. 

Mr. WAXMAN. And thank you, Mr. Chairman. 

Mr. SHIMKUS. The gentleman’s time has expired. The Chair now 

recognizes the gentleman from Ohio, Mr. Latta, for 5 minutes. 

Mr. LATTA. Mr. Drevna, if I can again start with you, how do you 

believe the coordination between the EPA and the TSCA interagency testing committee has been? 

Mr. DREVNA. That is a good question. I mean, I really don’t know 

what they have done. I don’t. 

Mr. LATTA. Have you heard anybody else talking about it? No 

one? OK. Well, maybe we ought to check into that. Mr. Matthews, 

if I could ask you currently, TSCA includes processes within the 

scope of Section 8, and in your testimony you discuss how a revised 

TSCA should expressly allow the EPA to collect necessary use information from downstream processors. How does this improve 

upon the existing construct? And then, just as a follow-up, then, do 

all processors support the view? Do all processors support this 

view? 

98 

Mr. MATTHEWS. Well, OK, I mean, I am here to speak on behalf 

of CSPA. I was at pains to say we are a segment of that industry. 

One of the problems the EPA has is they have had difficulty defining who a processor is. We circulated a 190 page document they 

created that attempted to define processor, but in the end, it 

couldn’t, so it is a very broad category. 

And, coming back to your first question, one of the problems, I 

think, is that EPA literally fears sending out an information request or demand from ‘‘processors’’ because it will produce more information than they can conceivably manage. What we have proposed is a more targeted and focused information flow of use and 

exposure information from that segment of the processor community that we represent, which is household and institutional products, which, during that screening phase, during the prioritization 

phase, will actually align with the kinds of issues that EPA is considering. And I would go back to the questions that have been 

asked about hazard, you still need hazard information, and there 

is substantial information on hazard that has already been generated, and EPA has its authorities in that regard. 

But you would combine that with the kind of information about 

exposures that EPA is concerned about, as it says, how do we work 

through tens of thousands of chemicals in a logical way? Which 

should be our priorities? And on that basis, the kind of information 

that we would provide I think would go a long way to answering 

those questions. 

Mr. LATTA. Thank you. Dr. Grazman, what is the EPA doing 

with all this duplicative byproduct data that they are collecting? 

Mr. GRAZMAN. That is a good question, sir, and I don’t know the 

answer. We have seen no evidence that they are doing anything. 

And part of this, and it actually goes back to the kind of—Mr. Waxman made quote in my written testimony, as I mentioned, we are 

a manufacturer. We make our products through a series of chemical and physical steps. None of the chemical steps is perfectly balanced. Each one produces a byproduct. 

And so right now, when I say we find it very difficult to report 

to EPA the amount and nature of each byproduct, it is because I 

have got 30 chemical processes that might use five different chemicals that we buy, and then I have to understand the amount of 

each component that is left over, how they may react, and how any 

recyclers I send it to may process it. So if you imagine that EPA 

is not only trying to handle the data from chemical manufacturers, 

but from people like us, it truly would be overwhelming. 

Mr. LATTA. Let me follow up. Even if these byproduct manufacture were to be exempted from reporting, companies manufacturing 

new chemicals from recycled byproducts would still be required to 

report on the manufactures they are manufacturing. Is that what 

would be happening, then, that they would—— 

Mr. GRAZMAN. Yes, sir. 

Mr. LATTA. Yes. 

Mr. GRAZMAN. The processors of our byproducts are reporting on 

what they make out of them. 

Mr. LATTA. OK. Mr. Drevna, if I could go back to you, I was kind 

of interested in what you were saying about Canada, and about the 

99 

model that they use up there. How would you rate the model that 

they use in Canada? 

Mr. DREVNA. Congressman, I think it is one that Congress 

should help EPA adopt. I think it is a good program. As one of the 

witnesses says, it would help, you know, categorize. It would help 

eliminate, and it is working for our friends to the north. 

Mr. LATTA. And I know that Mr. Murphy had asked a question 

a little bit earlier about this, or kind of touched on it, also in your 

testimony I found it interesting that many people are of the false 

impression that there are 80,000 chemicals in commerce, and you 

say it is something less than 10,000. Where did it ever come up 

that people thought there were 80,000? 

Mr. DREVNA. Well, I think once a chemical is out there on the 

list, it never gets off, and there are so many intermediates. It is 

a, you know, it is like the Hotel California, you can come in, but 

you can’t check out. 

Mr. LATTA. OK. On that Eagles note, I will yield back. 

Mr. SHIMKUS. Showing your age. So thank you. Now the Chair 

recognizes the gentlelady from the Denver Broncos, I mean from 

the great State of Colorado, Ms. DeGette, for 5 minutes. 

Ms. DEGETTE. Thank you so much, Mr. Chairman. And, in an attempt to be bipartisan, I will say we are working together very well 

on this TSCA reauthorization, and I am pleased that we are having 

this hearing. There is a group of us on this side of the aisle who 

really do want to work in developing this legislation, as we discussed last night, and I am hoping we can do it as it goes along. 

I think there is consensus that some of the biggest problems we 

have with the implementation of TSCA are rooted in the procedure 

requirements under Section 4 for testing existing chemicals, and so 

I want to focus on that during the first part of my questioning. 

Dr. Bosley, I wanted to ask you, yes or no, should the EPA have 

to go through a rulemaking every time it needs data on an existing 

chemical? 

Ms. BOSLEY. No, absolutely not. 

Ms. DEGETTE. And, Dr. Sass, what is your view on that? 

Ms. SASS. No, it should not, I agree. 

Ms. DEGETTE. OK. So it seems to me, I think everybody pretty 

much agrees on this, one of the easiest ways to improve TSCA 

would be to allow the EPA to request testing by order than rulemaking, especially for existing chemicals where the data probably 

already exists. Everybody is nodding, so, Mr. Matthews, I am going 

to pick on you for a second. 

I know you have got extensive experience providing counsel to 

chemical companies, and I am assuming that chemical companies, 

legitimate ones, like your clients, perform basic testing of the products they sell in order to determine they are safe. Is that right? 

Mr. MATTHEWS. Well, mind you, we are the downstream purchasers of—— 

Ms. DEGETTE. OK. 

Mr. MATTHEWS [continuing]. Raw materials from upstream. It is 

upstream where that actual testing of the chemical itself takes 

place, but our companies go to great lengths to ensure that the 

chemicals they put into their products are safe, so they are—— 

Ms. DEGETTE. Right. 

100 

Mr. MATTHEWS [continuing]. Looking at that data. 

Ms. DEGETTE. So both the manufacturers, but your clients too, 

they are not going to put those things on the market unless they 

are pretty sure they are safe? 

Mr. MATTHEWS. That would be absolutely correct. 

Ms. DEGETTE. And so both the downstream and upstream folks 

are going to have information on file about the effects of the products, right? 

Mr. MATTHEWS. I mean, I think often the manufacturers say it 

is not readily ascertainable to us as to how it is being used, and 

what kind of exposures are being created. So they have some, but 

not enough, for EPA’s purposes. That is where we come in. 

Ms. DEGETTE. OK. So what you said in your written testimony 

is exactly that, very little information is readily available to the 

agency on how chemicals are used in U.S. commerce in order to 

fully inform prioritization, and to assess the human health and environmental risk. That is exactly the point. So I guess I would like 

it if you could just spend a second talking to me about what you 

think about the current process of rulemaking, and what could be 

done to help the EPA access this information better. Would your 

clients agree with a different system, and what would it be? 

Mr. MATTHEWS. Indeed we would. We would propose that there 

actually be statutory changes that would address a more direct and 

meaningful role of the downstream community that has—— 

Ms. DEGETTE. I mean, we are drafting the bill, so what kinds of 

changes would you support? 

Mr. MATTHEWS. We would support a statute directing EPA when 

it goes through this screening process, I mean, we are trying to 

thread the needle here. They have to—— 

Ms. DEGETTE. Right. 

Mr. MATTHEWS [continuing]. Screen to get the prioritization to 

get a list of substances that will go through a safety assessment 

process. So, as they conduct that initial screening, they have substantial information at their disposal. And we are talking—— 

Ms. DEGETTE. So you would support them providing that information to the EPA? 

Mr. MATTHEWS. I think the EPA generally has a lot of that information, but yes, any updated information should—— 

Ms. DEGETTE. Without rulemaking? 

Mr. MATTHEWS [continuing]. From the manufacturers. 

Ms. DEGETTE. Right. 

Mr. MATTHEWS. And now we would propose adding to that provisions that would direct the agency to also, then, collect, for the substances under review, use and exposure information from the companies that have it. 

Ms. DEGETTE. Great. Thank you. Now, Dr. Paulson, I want to 

talk for a minute about the EPA authority, because, you know, 

they have got 83 existing chemicals right now, so that is good, but 

as the EPA studies those priority chemicals, science will evolve, 

and we might know more about those chemicals that are not on the 

priority list. So, Dr. Paulson, you support a simpler process for the 

EPA to gather data. Can you just talk briefly about how our understanding has evolved, and how chemicals affect infants, children, 

and other vulnerable populations? 

101 

Mr. PAULSON. Yes, ma’am, thank you. Children have periods of 

vulnerability from the time that really actually start before conception, if we can understand that, conceptualize that, and then, after 

conception, throughout pregnancy, and the brain finally finishes 

developing somewhere around 25 years of age, in terms of final 

myelination of coding of the nerve cells in the frontal part of the 

brain. Likewise, the lungs continue to develop until children reach 

whatever their adult height is, so this is a process that takes many, 

many years, and damage that is done before the process has finished, whether you are talking about the lungs, or the brain, or the 

kidney, often is irremediable. You don’t get to start over or do-over 

in the human body. 

So data that is collected to make decisions on the safety of chemicals needs to acknowledge these periods of vulnerability, test 

around issues that pertain to these periods of vulnerability, and 

then use that information in decision-making. 

Ms. DEGETTE. Thank you, Mr. Chairman. 

Mr. SHIMKUS. The gentlelady’s time has expired. I do look forward to working with her, and if you check on 8(d), I am not going 

to read this part, but part of that is in current law too, and that 

is part of the problem of some of the things that you asked about. 

The Chair now recognizes the gentleman from West Virginia, Mr. 

McKinley, for 5 minutes. 

Mr. MCKINLEY. Thank you, Mr. Chairman. Several of the panelists, and some of the Members of Congress, have mentioned and 

drawn attention back to the problem they had down in the 2nd District in West Virginia, down in the southern part of the State. And 

I join with you in the disgust and the fury internally I have over 

the breakdown of why that could occur. So I am hoping that, from 

this hearing and elsewhere, we will learn more, and not do a kneejerk reaction, but we will try to get this thing resolved. I know the 

Attorney General is looking into it, and a series of others are looking into that. 

But let me go back to Dr. Paulson, and some of your remarks. 

In your testimony you said that, under TSCA Section 8, companies 

are required to keep a file of allegations of significant adverse reactions to human health or the environment of any chemical they 

manufacture, and the companies must also provide this information to the EPA upon request. Now, I am just curious, given the 

MCHM issue of a discharge into the Elk River, do any of you know, 

was there a request that was denied about the MCHM? 

Mr. PAULSON. I am sorry, can you state the last part of that 

question again? Just didn’t quite hear you. 

Mr. MCKINLEY. Did the EPA, did they seek information about 

this? Because that is what it says, companies must provide this information to the EPA upon request. Did the EPA request information about this chemical, one of two chemicals that was discharged 

into the Elk River? 

Mr. PAULSON. In the post-leak time phase, I don’t know, sir. 

Mr. MCKINLEY. OK. Well, let us go just a little bit further with 

that. Is there something more that they can do? Because I heard 

a little bit ago you were saying, I think, in your testimony that 

these things deal with confidentiality. I am just wondering whether 

or not that was also an item that—was it held back because of— 

102 

or, Dr. Sass, do you know whether or not either of these things has 

occurred? 

Ms. SASS. So I do not know the specifics of conversations that 

may have happened early in the spill between EPA and West Virginia, but I think what the speakers had talked about, if I am correct, referring to your question, is the idea that, if there is an accident, or a spill, or an incident like this, that it should be reported 

to EPA. 

And the model, I think, is FIFRA 6(a)(2), which is the pesticide 

model, so that if there is an incident, or a spill, or a poisoning, that 

a report has to be made to EPA under FIFRA 6(a)(2), and that data 

is kept there, and that the obligation to make that is the registrant, the chemical manufacturer in this case. And that way EPA 

has a docket of these. And so later, when EPA is reviewing those 

pesticides, which it does every 15 years on a routine basis, and updates the science, it can look and see if there has been a problem 

with fish kills, with worker poisonings, child poisonings, things like 

that. 

Mr. MCKINLEY. How we can strengthen it, how we can make this 

thing work better, because was this information even available? 

That is what I am trying to find out about the MCHM, was it out 

there? 

Mr. PAULSON. We do know—— 

Mr. MCKINLEY. Because the first responders needed to know. 

There was the delay in reporting. We have got to find out how to 

make this thing better, and so I am looking under Section 8, how 

we might be able to modify that. 

Mr. PAULSON. Well, we do know that the company, Eastman, did 

provide some additional information, and I don’t know whether 

that was at the request of EPA, the agency for Toxic Substances 

and Disease Registry—— 

Mr. MCKINLEY. OK. So—— 

Mr. PAULSON [continuing]. The West Virginia Department of 

Health. So they did, in relatively short order, provide some additional information. Then the Federal agencies needed to analyze 

that, which, of course, takes time. I think that, had this information been provided to the government before the spill, there might 

have been a quicker turnaround. 

Mr. MCKINLEY. Well, that is what I am trying to find out, is why 

it failed under Section 8, that they didn’t provide that information 

prior to this. That is what I am trying to find out about. 

But let me just close in the few seconds we have left that I join 

with you in this concern about what happened down there, and the 

need to work on TSCA. I am with you on that, as one of just two 

engineers here in Congress. We need to work on this. But I wish 

I could have seen the same fury from you all about the situation 

in Bud, West Virginia. Bud, West Virginia, for those of you that 

aren’t aware, they have been without water, this is their sixth 

month. 

And for a community, Dr. Willett, you are only concerned with 

the animal, where are they getting the water? Because it is untreated. And these people, for six months, have gone without water 

down in Wyoming County, West Virginia. Six months. And I 

haven’t seen anything in the headlines about that. You know, peoVerDate Aug 31 2005 08:56 Jul 03, 2014 Jkt 037690 PO 00000 Frm 00106 Fmt 6633 Sfmt 6633 F:\113-11~2\113-11~1 WAYNE
103 

ple chasing that issue, take care of those families, the children 

looking for water in their fountains, and their school districts are 

closed. I know you don’t have jurisdiction over that, but I would 

think many of the advocates out there in America would have 

raised this issue, that that is not an acceptable way for a community to exist. They have to rely for six months on bottled water. 

Afraid my time is over. 

Mr. SHIMKUS. The gentleman’s time has expired. 

The Chair now recognizes the gentleman from California, Mr. 

McNerney. 

Mr. MCNERNEY. Did the gentleman yield? 

Mr. TONKO. Mr. Chair, if I might, I think that that line of questioning from our colleague is important, because it highlights one 

of the failures of the existing law, in that it didn’t require the company to notify the EPA of the substance, so vast improvements are 

required here. 

Mr. SHIMKUS. I thank my colleague. I would just remind my colleagues that there is Federal law called the Emergency Planning 

and Community Right to Know Act, under which they should have 

filed with the local first responders. The second thing, under Section 8(e), is peril authority, and so is 8(c), that this information 

should have been filed with the EPA. So, having that, I will turn 

to Mr. McNerney for 5 minutes. 

Mr. MCNERNEY. I thank the Chairman. I just want to say, all the 

testimony I have heard this morning was very constructive, very 

positive, in terms of where we should be going, and I appreciate 

that. 

Dr. Paulson, in your testimony, you raised concern about chemical companies claiming that important health and safety data is 

confidential business information. Have CBI claims made it difficult for key stakeholders to gain information about potentially 

hazardous chemicals? 

Mr. PAULSON. To the extent that we don’t know what is included 

in the CBI claims, I can’t answer that definitively, but certainly 

that is a big concern. I think there is information that should be 

available to the public that these companies know, and they are 

making claims of CBI that lock the public’s right to know. 

Mr. MCNERNEY. Well, today the committee received a letter from 

the Center for Environmental Health regarding today’s hearings on 

Sections 4 and 8 of TSCA. Mr. Chairman, I request that this letter 

be made a part of the hearing. 

Mr. SHIMKUS. Without objection, so ordered. I think we have already seen it. 

Mr. MCNERNEY. Thank you. According to the letter, the Center 

for Environmental Health, and I quote, ‘‘is particularly concerned 

with whether or not the EPA has enough data to make appropriate 

designation for individual chemicals. Any revision of TSCA must 

ensure that the EPA has adequate data to demonstrate that the 

chemical truly has a reasonable certainty of no harm before the 

agency deems the chemical to be a low priority’’. Then they go on 

to note that the law must require chemical companies to submit 

minimum information sets in a timely manner, equipping the EPA 

to evaluate new chemicals and new uses of chemicals, and to evaluate chemicals for prioritization. 

104 

Mr. Paulson, what is your biggest concern about what the revision of TSCA might not do? 

Mr. PAULSON. My biggest concern is that a revision to the Toxic 

Substances Control Act would not allow EPA to collect sufficient 

data to make decisions. And they can’t make good decisions without good data. There need to be identified minimum data sets that 

will collect information that pertains to children and pregnant 

women, at least from my standpoint, as a pediatrician. They are 

not the only groups that need protection, but let me just talk as 

a pediatrician, and that, unless any new legislation gives them that 

authority, gives them the authority to request additional information when they feel that it is necessary, and gives them the authority to continue to receive information after a marketing decision 

has been made, then we will all be right back here, talking about 

problems with chemical management policy. 

Mr. MCNERNEY. Thank you. Dr. Sass, do you have additional 

concerns about what the new legislation may not accomplish? 

Ms. SASS. I think that my biggest, is actually that it won’t give 

EPA the authority to actually make a decision to take action, that 

it will hold EPA in a holding pattern forever, collecting information, and needing more information, and waiting for information, 

and that would be sad, because there are huge initiatives across all 

agencies to develop more rapid and less costly testing. And I think 

that Dr. Willett had mentioned some of these. We can start to do 

mixtures, we can do formulations, we can look at interactions, different life stages. There are some exciting new scientific data on 

the horizon, the near and the far horizon. Computational toxicology 

will be really exciting, and it would be a shame if EPA was hamstrung in an old dinosaur science framework. 

Mr. MCNERNEY. Thanks. Mr. Drevna, what is your biggest concern about what the new legislation may do? 

Mr. DREVNA. Two things, Congressman. One, we have to keep in 

mind that this is a health and an environment statute, and it is 

a commerce statute. And one of the things of a major concern to 

us is Federal pre-emption. We would urge Congress, in its revisit 

and rewrite of TSCA, to make sure that, you know, as I said, that 

we don’t, you know, inhibit the manufacturing renaissance by having a patchwork quilt of kinds of various State regulations. I mean, 

this is a statute that calls for Federal pre-emption. 

Mr. MCNERNEY. Anyone else on the panel wish to answer that 

question? What is your biggest concern about what the legislation 

may do? All right. 

With that I will yield back, Mr. Chairman. 

Mr. SHIMKUS. The gentleman yields back his time. The Chair 

now recognize the gentleman from Ohio, Mr. Johnson, for 5 minutes. 

Mr. JOHNSON. Thank you, Mr. Chairman, and I too want to 

thank the panel for being with us today. Let me start with Dr. 

Willett and Dr. Bosley, if I could. 

How do you respond to the call for a minimum data set on all 

chemicals on the TSCA inventory, and why? Dr. Willett, you go 

first. 

Ms. WILLETT. I believe that our science and technology is at the 

point where we can redefine what minimum data set means. 

105 

Mr. JOHNSON. OK. Dr. Bosley? 

Ms. BOSLEY. I think that the general industrial chemicals are not 

a one size fits all, and I think a minimum data set is the wrong 

approach. I think that the data sets that EPA needs should be 

based on the risk of the chemical. 

Mr. JOHNSON. OK. For both of you, a follow on, is every data gap 

a data need, in your opinion, and why? 

Ms. WILLETT. That is a tough question. No. 

Mr. JOHNSON. OK. 

Ms. WILLETT. I think EPA should be allowed to figure out which 

data gap is really a data need. They are, as I said, very talented 

scientists and engineers there, and they know what data they need. 

Mr. JOHNSON. OK. Dr. Willett, a follow on for you. You mentioned that a single two-generation reproductive toxicity study requires at least $380,000, 2 years, and 2,600 rats. Is this kind of 

test normal under a minimum data requirement? 

Ms. WILLETT. It depends on the chemical sector, but it is a common test that is required now. 

Mr. JOHNSON. So it would be considered normal? OK. Mr. 

Grazman, how are you today? 

Mr. GRAZMAN. Good, thank you, sir. 

Mr. JOHNSON. How are things back in North Jackson? 

Mr. GRAZMAN. North Jackson is doing well. 

Mr. JOHNSON. Good. Mr. Grazman, Section 9 of TSCA directs the 

EPA to coordinate TSCA actions with actions taken under other 

Federal laws to avoid unnecessary duplication. As a manufacturer, 

are you aware of any steps that EPA has taken to coordinate reporting requirements—— 

Mr. GRAZMAN. No, sir—— 

Mr. JOHNSON [continuing]. Or processes? 

Mr. GRAZMAN [continuing]. We are not aware of any. 

Mr. JOHNSON. You are not aware of any coordination—— 

Mr. GRAZMAN. We have—— 

Mr. JOHNSON [continuing]. Done? 

Mr. GRAZMAN. We report, and for understandably good reasons, 

to multiple divisions of government, and organs of government, 

that ask for the data. 

Mr. JOHNSON. OK. 

Mr. GRAZMAN. Whether it is the first responders in our area, 

whether it is the environmental pluses of business, it is everybody 

from our insurers, and our own shareholders, and our own systems, 

so—— 

Mr. JOHNSON. Same data? 

Mr. GRAZMAN. Pardon? 

Mr. JOHNSON. Same data? 

Mr. GRAZMAN. Yes. 

Mr. JOHNSON. OK. Can you describe for the subcommittee the 

environmental reporting that your company undertakes under 

other laws? Now, you just mentioned a few of them, and how that 

may overlap with reporting requirements under Section 8 of TSCA? 

Mr. GRAZMAN. To do a complete job, I would really rather follow 

up with you later and—— 

Mr. JOHNSON. OK. 

Mr. GRAZMAN [continuing]. That information. 

106 

Mr. JOHNSON. Yes, if you could get us that, that would be great. 

Mr. GRAZMAN. Yes, sir, happy to. 

Mr. JOHNSON. What steps does your company take to ensure the 

responsible use, storage, and transfer of chemicals? What laws, for 

example, regulate these activities? 

Mr. GRAZMAN. Every material that we bring in our factory is 

evaluated for its safety in terms of its storage, its handling to our 

workers, and its possible interactions with the other chemicals that 

we use. Everybody from our insurance company to the third party 

registrar of our environmental management system audits our facilities against both the chemical and the handling aspects of those 

things. We have customers doing audits, because when a Department of Defense program is buying their circuit boards from us, if 

our factory fails, potentially they fail. So they are in making sure 

that our processes are safe, and will provide a continued stream of 

products that they need. 

Mr. JOHNSON. OK. 

Mr. GRAZMAN. And then we have actually instituted a program 

called layer process audits, where literally every day every part of 

the factory is being looked at against checklists for safety and efficiency. 

Mr. JOHNSON. Are there any regulatory gaps that we should 

worry about closing? 

Mr. GRAZMAN. I think the aspect of the regulation that surprised 

us when we chose to start recycling, that we got hit as if we were 

manufacturing chemicals. I would like to see that closed, and I 

think that would also help EPA in reducing the data they need so 

that they can focus on those that are necessary for—— 

Mr. JOHNSON. OK. 

Mr. GRAZMAN [continuing]. Their effectiveness. 

Mr. JOHNSON. Well, thank you for that. 

Mr. Chairman, I yield back. 

Mr. SHIMKUS. The gentleman yields back his time. The Chair 

now recognizes my colleague from the State of Illinois, Ms. 

Schakowsky, for 5 minutes. 

Ms. SCHAKOWSKY. Thank you, Mr. Chairman, and to our panel. 

I really apologize, I was at another hearing and couldn’t come and 

hear your testimony, but I do have a few questions. 

As written, Section 4 of TSCA makes it extremely difficult for the 

EPA to require testing of existing chemicals, but that doesn’t mean, 

as has been discussed, the chemical companies never conduct any 

tests on these chemicals. They may conduct safety testing for a variety of reasons, apart from any requirement on TSCA. A company 

could conduct safety tests to comply with the State law, to meet 

European requirements, if you want to export, or a company may 

want to conduct testing to assess potential tort liabilities. 

So, Dr. Bosley, is that right, that companies may conduct safety 

tests on a chemical for a variety of reasons? 

Ms. BOSLEY. Yes. We conduct tests whether or not EPA asks for 

them in general. 

Ms. SCHAKOWSKY. And Mr. Matthews? 

Mr. MATTHEWS. Yes—are not doing the actual toxicity testing, 

but they don’t put a product on the market where they haven’t reVerDate Aug 31 2005 08:56 Jul 03, 2014 Jkt 037690 PO 00000 Frm 00110 Fmt 6633 Sfmt 6633 F:\113-11~2\113-11~1 WAYNE
107 

viewed the toxicity of each of the chemicals they put in those products. 

Ms. SCHAKOWSKY. But the EPA and other health officials often 

don’t see these tests. As we have discussed also, Section 8 only requires chemical companies to immediately submit to the EPA information they obtained that, quote, ‘‘reasonably supports the conclusion’’ that a chemical, quote, ‘‘presents a substantial risk of injury 

to health or the environment’’. 

So, Dr. Paulson, in your testimony, you say that TSCA has created a non-evidence based system for chemical management. Can 

you explain what you mean by this? 

Mr. PAULSON. In medicine, in the latter part of the 20th century, 

in the early part of the 21st century now, we talk about practicing 

evidence based medicine, that the decisions that we make should 

be based on rigorously collected information to inform those decisions. So I have taken that term that is used in medicine and applied it to a different arena. And what I am suggesting here is that, 

in terms of new chemicals, the companies are, in essence, penalized 

if they do research, because they are required then to report that 

research to EPA, and EPA might then use that research to make 

a decision the company doesn’t want made. 

And, in terms of the chemicals currently on the market, the 

quote that you just read, in terms of the definition of substantial, 

that makes it very easy for companies to decide that it is not substantial. And I think the standard should be that companies need 

to disclose information that they have. 

Ms. SCHAKOWSKY. Thank you. The recent chemical spill in West 

Virginia, which you have also talked about, illustrates the problems created when chemical testing data isn’t widely shared and 

available. On January 11 the Centers for Disease Control told West 

Virginians that the water would be safe to drink at one part per 

million of the chemical of concern, MCHM. Four days later CDC 

said it obtained new animal studies leading it to recommend that 

pregnant women not drink the water at all. EPA told committee 

staff that the agency didn’t have any studies on the chemical. A 

week after the chemical spill was discovered, Eastman, the chemical manufacturer, finally made public the summaries of several 

safety studies. 

Dr. Sass, how did this slow disclosure of the relevant safety studies affect your ability, as a scientist, to assess whether government 

was doing enough to protect public health? 

Ms. SASS. Well, in the first few days, the public was completely 

blindsided, and blinded, with no information. The LD–50, the lethal dose that kills 50 percent of test animals, which is very crude, 

and not the kind of test we want to use to set a drinking water 

standard for a population, was the only test that seemed to be 

available. I found it on an MSDS, or a material safety data sheet. 

That is what CDC used initially. 

Later they found a no effect test in rodents, a 28 day rodent test, 

which they used. That is more informative. The problem with that 

test is that only the conclusions of the study were provided to the 

public, so there was no way to analyze those data, or to re-analyze 

the data, or to confirm it was a, you know, trust us, we are the 

experts type of study from the industry, and that is wholly inapproVerDate Aug 31 2005 08:56 Jul 03, 2014 Jkt 037690 PO 00000 Frm 00111 Fmt 6633 Sfmt 6633 F:\113-11~2\113-11~1 WAYNE
108 

priate for public health agencies, first responders, scientists, and 

the public to get any confirmation. So I think that it violated the 

public trust, and it put public interest groups in a blinded position, 

and it hamstrung the Federal agencies considerably. 

Ms. SCHAKOWSKY. Let me just say that I think that it really affected the confidence of the West Virginians, both in the safety of 

their water, and in the government’s ability to respond. 

Thank you, I yield back. 

Mr. SHIMKUS. The g entlelady yields back her time, and we want 

to thank you all. We think it was a great hearing. I want to ask 

unanimous consent that all subcommittee members have 5 days to 

submit opening statements for the record. Without objection, so ordered. Members will have 10 requisite days to submit questions for 

the record, so if you follow up with questions, if you would submit 

those back to us? I think it is very, very important because, as you 

see, we had a lot of active members very interested in this. 

I think it is safe to say that there is need for reform across the 

board. I think there is desire by the stakeholders and members. I 

think also the status quo is really not acceptable. I think people 

concur with that. Cautionary note is don’t let the perfect be the 

enemy of the good as we try to work through this process. 

And, with that, I want to thank my colleagues for attending, and 

I will now adjourn the hearing. 

[Whereupon, at 12:07 p.m., the subcommittee was adjourned.] 

Æ