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S. HRG. 109–1078 

TOXIC SUBSTANCES CONTROL ACT AND THE 

CHEMICALS MANAGEMENT PROGRAM AT EPA 

HEARING 

BEFORE THE

COMMITTEE ON 

ENVIRONMENT AND PUBLIC WORKS 

UNITED STATES SENATE 

ONE HUNDRED NINTH CONGRESS 

SECOND SESSION 

August 2, 2006 

Printed for the use of the Committee on Environment and Public Works 

( 

Available via the World Wide Web: http://access.gpo.gov/Congress.senate 
COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS 

ONE HUNDRED NINTH CONGRESS 

SECOND SESSION 

JAMES M. INHOFE, Oklahoma, Chairman 

JOHN W. WARNER, Virginia 

CHRISTOPHER S. BOND, Missouri 

GEORGE V. VOINOVICH, Ohio 

LINCOLN CHAFEE, Rhode Island 

LISA MURKOWSKI, Alaska 

JOHN THUNE, South Dakota 

JIM DEMINT, South Carolina 

JOHNNY ISAKSON, Georgia 

DAVID VITTER, Louisiana 

JAMES M. JEFFORDS, Vermont 

MAX BAUCUS, Montana 

JOSEPH I. LIEBERMAN, Connecticut 

BARBARA BOXER, California 

THOMAS R. CARPER, Delaware 

HILLARY RODHAM CLINTON, New York 

FRANK R. LAUTENBERG, New Jersey 

BARACK OBAMA, Illinois 

ANDREW WHEELER, Majority Staff Director 

KEN CONNOLLY, Minority Staff Director 

(II) 
(III) 

C O N T E N T S 

Page 

AUGUST 2, 2006 

OPENING STATEMENTS 

Boxer, Hon. Barbara U.S. Senator from the State of California ........................ 29 

Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma .................... 1 

Jeffords, Hon. James M., U.S. Senator from the State of Vermont, prepared 

statement .............................................................................................................. 30 

Lautenberg, Hon. Frank R., U.S. Senator from the State of New Jersey, 

prepared statement .............................................................................................. 9 

WITNESSES 

Charnley, Gail, Ph.D., President, Healthrisk Strategies ...................................... 19 

Prepared statement .......................................................................................... 86 

Responses to additional questions from: 

Senator Boxer ............................................................................................ 96 

Senator Inhofe ........................................................................................... 94 

Senator Jeffords ......................................................................................... 95 

Goldman, Lynn R., M.d., M.p.h., Professor, Environmental Health Sciences, 

Johns Hopkins University, Bloomberg School of Public Health ...................... 14 

Prepared statement .......................................................................................... 73 

Responses to additional questions from: 

Senator Inhofe ........................................................................................... 77 

Senator Jeffords ......................................................................................... 79 

Gulliford, James B., Assistant Administrator, Office of Prevention, Pesticides 

and Toxic Substances, U.S. Environmental Protection Agency ....................... 2 

Prepared statement .......................................................................................... 31 

Responses to additional questions from: 

Senator Boxer ............................................................................................ 35 

Senator Clinton ......................................................................................... 40 

Senator Inhofe ........................................................................................... 34 

Senator Jeffords ......................................................................................... 35 

Rawson, William K., Partner and Chair of the Environment, Land and Resources Department, Latham and Watkins ....................................................... 12 

Prepared statement .......................................................................................... 61 

Responses to additional questions from: 

Senator Inhofe ........................................................................................... 70 

Senator Jeffords ......................................................................................... 73 

Stephenson, John B., Director, Natural Resources and Environment, U.S. 

Government Accountability Office ...................................................................... 4 

Responses to additional questions from: 

Prepared statement .......................................................................................... 41 

Senator Boxer ............................................................................................ 50 

Senator Inhofe ........................................................................................... 48 

Walls, Michael P., Managing Director of Regulatory and Technical Affairs, 

American Chemistry Council .............................................................................. 16 

Prepared statement .......................................................................................... 52 

Responses to additional questions from: 

Senator Boxer ............................................................................................ 59 

Senator Inhofe ........................................................................................... 56 

Senator Jeffords ......................................................................................... 58 

Wilson, Michael P., Ph.D., M.p.h., University of California, Berkeley ................ 17 

Prepared statement .......................................................................................... 81 
Page

IV 

Wilson, Michael P., Ph.D., M.p.h., University of California, Berkeley—Continued 

Responses to additional questions from: 

Senator Inhofe ........................................................................................... 83 

Senator Jeffords ......................................................................................... 85 

ADDITIONAL MATERIAL 

Reports: 

California Policy Research Center, University of California; Green 

Chemistry in California: A Framework for Leadership in Chemicals 

Policy and Innovation ............................................................................ 142 

William K. Rawson, Latham & Watkins LLP; Defense of the Toxic 

Substance Control Act (TSCA) Section 6: An Explanation of Corrosion Proof Fittings ................................................................................. 125 

Statements: 

The Deirdre Imus Environmental Center for Pediatric Oncology; 

S. 1391—Bill to Amend the Toxic Substance Control Act (TSCA) .... 123 

The Synthetic Organic Chemical Manufacturers Association; ‘‘The 

Toxic Substances Control Act’’ .............................................................. 97 
(1) 

TOXIC SUBSTANCES CONTROL ACT AND THE 

CHEMICALS MANAGEMENT PROGRAM AT EPA 

WEDNESDAY, AUGUST 2, 2006 

U.S. SENATE, COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS, Washington, DC. 

The committee met, pursuant to notice, at 9:30 a.m. in room 406, 

Dirksen Senate Office Building, Hon. James Inhofe (chairman of 

the committee) presiding. 

Present: Senators Inhofe, Jeffords, Lautenberg, Carper, Thune, 

Warner, Boxer. 

OPENING STATEMENT OF HON. JAMES M. INHOFE, 

U.S. SENATOR FROM THE STATE OF OKLAHOMA 

Senator INHOFE. The hearing will come to order. 

Because of a development, we are going to change the order of 

things a little bit from what we had planned. We are going to go 

ahead and proceed with opening statements from the panel and 

then questions, and then the next panel, opening statements and 

questions. Because we have to recess this hearing at 11 o’clock to 

reconvene at the event we are not concluded at that time at 3 

o’clock today in the same place. 

So why don’t we go ahead and start. We are actually going to 

defer any opening statements also until 3 o’clock. 

If you would like to go ahead and start, Mr. Gulliford, now that 

Senator Jeffords is here, begin with your opening statement. 

[The prepared statement of Senator James M. Inhofe follows.] 

STATEMENT OF HON. JAMES M. INHOFE, U.S. SENATOR FROM

THE STATE OF OKLAHOMA

Good morning. Today’s hearing is a very important one. The Committee has not 

held a hearing on the chemicals management program at EPA in more than 10 

years. 

There are many people who come to this hearing with a preconceived notion that 

the U.S. chemicals management program is broken and that Congress needs to completely rewrite the Toxic Substance Control Act (TSCA). I do not come into this 

hearing with that assumption and I look forward to hearing from the witnesses how 

they believe the statute and the program are working. However, it is important to 

take a look at how our environmental statutes are being put into practice, which 

is why shining light on EPA implementation of TSCA with this hearing is so important. Government bureaucracies only work well when there is Congressional oversight. 

The chemical industry is a crucial part of the U.S. economy. The United States 

is the number one chemical producer in the world, generating $550 billion a year 

and putting more than 5 million people to work. More than 96 percent of all manufactured goods are directly touched by chemistry. 
2 

Chemicals are the essential building blocks of products that safely and effectively 

prevent, treat and cure disease; ensure the safest and most abundant food supply 

in the world; purify our drinking water and put out fires. They are the foundation 

for life-saving vaccines, child safety seats, bicycle helmets, home insulation, and 

Kevlar vests. Innovations in chemistry have helped to increase energy efficiency and 

to make planes, fighter jets, satellites and space shuttles safer and more secure. We 

are also on the cusp of new and exciting chemical advances in the form of nanotechnology. These tiny chemicals have the potential to cure cancers, clean up pollution, 

and make cars stronger and lighter than ever before. To say that chemicals are vital 

is an understatement. 

There are those that suggest the mere presence of chemicals in our bodies is cause 

for alarm. However, the Centers for Disease Control in its biennial report on 

Human Exposure to Environmental Chemicals states, ‘‘just because people have an 

environmental chemical in their blood or urine does not mean that the chemical 

causes disease. The toxicity of a chemical is related to its concentration in addition 

to a person’s individual susceptibility.’’ 

This is not to say that we should ignore human health and environmental risks 

if they do, based on scientific evidence, exist. For nearly 30 years, chemical products 

have been among the most thoroughly evaluated and regulated, covered by more 

than a dozen Federal laws, including TSCA. These statutes are centered on the concept of regulating substances based on risk. I do not believe American chemicals innovation should be stifled by Government regulation without the clear identification 

of risk. We need to ensure that we regulate chemicals based on demonstrated risk 

not the just the perception or assumption of it. That ‘‘precautionary’’ concept is one 

that I cannot support. 

In reviewing the statute and its legislative history it appears that the Congress 

was very deliberate in the powers it granted EPA under TSCA and appropriately 

balanced them with burdens on the private sector. For example, TSCA gives EPA 

the power to limit or prohibit the manufacture and distribution of a substance if 

it is found to pose an unreasonable risk. Chemical product makers are required to 

submit information on all newly developed chemicals BEFORE they are even manufactured. If EPA has concerns, it has the power to mandate testing and then to control or ban it. In nearly 30 years, EPA estimates that 20,000 new chemicals have 

gone into commercial production by going through the new chemicals review process 

and never over the objection of EPA. 

EPA has also created effective new programs to ensure that we have chemical 

safety data on those existing chemicals that are produced or imported in the United 

States in large quantities. This program is called the High Production Volume 

(HPV) Challenge program and covers approximately 95 percent of current U.S. 

chemical production and use by volume. Through the program, seventeen types of 

information are being collected, including physical-chemical properties, environmental fate, and human and aquatic organism toxicity. This information is identical 

to the internationally-agreed upon Screening Information Data Sets, established by 

the 30 nations of the Organization for Economic Cooperation and Development. 

There is no shortage of strong feelings when it comes to chemicals and how they 

are regulated and managed. I look forward to hearing from our witnesses today regarding the success of the chemicals program at EPA and its principal statute. And 

perhaps we will uncover implementation problems that this committee, exercising 

its oversight, can encourage the Agency to rectify. 

STATEMENT OF JAMES B. GULLIFORD, ASSISTANT ADMINISTRATOR, OFFICE OF PREVENTION, PESTICIDES AND TOXIC 

SUBSTANCES, U.S. ENVIRONMENTAL PROTECTION AGENCY 

Mr. GULLIFORD. Thank you, Mr. Chairman, Senator Jeffords. I 

want to thank you for the opportunity to appear today, but I also 

want to thank you for your support during my recent confirmation 

process. As I said during that process, I am committed to working 

with each of you to fully understand the issues, to seek solutions, 

to facilitate change and collaborate on the challenges that we face. 

I would also like to thank John Stephenson and his staff at GAO 

for their engagement in the work of my office. While we may not 

always agree on a specific path, we share the same goal of implementing our laws in the most efficient and effective ways possible. 
3 

I want to assure you that EPA takes very seriously its commitment to protect human health and the environment from the adverse effects of chemicals. I believe that TSCA has been used effectively over the past three decades to provide those vital protections 

for the American people and the environment. It is a statute that 

has broad ranging authorities, and it has allowed us to use the 

right tool for the right job. It is a statute that is science-based, recognizes the role that social and economic factors have in common 

sense regulation, and is flexible enough to work in harmony with 

other statutes and other risk management approaches. It gives us 

the authority and the flexibility that we need to effectively manage 

both new and existing chemicals as well as producers of biotechnology and nanotechnology. As the environmental challenges 

that we have faced have evolved, so too has our use of TSCA. 

Leveraging our authorities under TSCA with the principles of environmental stewardship, pollution prevention and innovation, I believe that we have developed and maintained a successful and comprehensive regulatory framework for chemicals management. Let 

me share a few of our accomplishments. 

The TSCA New Chemicals program has been recognized nationally and internationally as a model regulatory program for assuring 

the safety of new chemicals as they enter the marketplace. Since 

1979, the program has received and reviewed over 45,000 new 

chemical notices. Using both regulatory and voluntary approaches, 

the United States has been in a leadership position worldwide in 

identifying and managing risks associated with existing chemicals. 

For example, while we are not yet a part to the POPS treaty, although as you know we are working very diligently to get there, 

the United States has already banned or severely restricted all of 

the original 12 POPS chemicals before the treaty was even drafted. 

Under TSCA authorities, as well as innovative partnership approaches, the United States has developed an extensive and publicly available data base on chemical hazard information. We have 

developed sophisticated modeling programs to predict the chemical’s toxicity, as well as peer-reviewed models to identify chemicals 

that may be persistent and bioaccumulative. 

We have made these programs available to industry to use in the 

design and development of safer and greener new chemicals. We 

are seeing that shift take place as well. 

Innovative partnership programs, such as the HPV program, 

have considerably increased the pace of environmental progress. 

We have worked to ensure that pollution prevention is the tool of 

first choice for our Nation. Stopping pollution before it starts is 

clearly the most sustainable approach that we can pursue. 

Let me cite some additional accomplishments. The voluntary 

stewardship programs are very important. EPA, working cooperatively with the chemical industry and the environmental community, launched the High Production Volume (HPV) challenge program. This program sought commitments from chemical manufacturers to make basic health and safety data publicly available on 

about 2,800 chemicals produced in the United States at more than 

1 million pounds annually. These HPV chemicals account for more 

than 93 percent of the production volume from the chemicals that 
4 

we track on the inventory. Under the Bush administration, data 

has been submitted on 97 percent of the HPV chemicals. 

The Agency has in turn met its commitment to making that information publicly available. We launched the HPV public information system in March of this year, and will further engage the public in a December data use conference. The HPV program is now 

being extended by industry to develop these same health and safety 

data on an additional 500 HPV chemicals. There is no denying that 

these are real results and will lead to both greater understanding 

of chemicals and better protection of public health and the environment. 

For new chemicals, when TSCA was passed in 1976, there were 

62,000 chemicals placed on the TSCA inventory. Since that time, 

EPA has reviewed more than 45,000 new chemical submissions. 

Twenty thousand, roughly, have been added to the inventory, but 

only after detailed review by EPA. 

For existing chemicals, from Section 8 requirements, the Agency 

has the ability to require record keeping and reporting on a wide 

range of data, including production volume information, health and 

safety data and substantial risk information. This is critical information in developing risk assessments. 

We recently amended the inventory update reporting rule to obtain exposure data on HPV chemicals to help inform the risk-based 

assessments on these chemicals. In this area, more than 50,000 

health and environmental studies have been submitted to the 

Agency. This information is also helpful to EPA, but also a number 

of other Federal agencies that use this data. 

EPA has also received industry submissions under TSCA Section 

8 of substantial risk information, which alerts EPA to critical new 

test data. This test data has been highly valuable in identifying 

chemicals for information. 

In closing, let me say we are most appreciative of today’s opportunity for the hearing, the ongoing interest of the Committee in 

TSCA and the work of GAO. There are many dedicated engineers, 

chemists, biologists, toxicologists, economist, statisticians, attorneys 

and other civil servants who work directly on TSCA issues for EPA. 

I am proud of their achievements and proud to support their work 

today. 

Thank you. 

Senator INHOFE. Thank you, Mr. Gulliford. It is an excellent 

statement. 

Mr. STEPHENSON. 

STATEMENT OF JOHN B. STEPHENSON, DIRECTOR, NATURAL 

RESOURCES AND ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY OFFICE 

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

Committee. I am pleased to be here today to discuss our work on 

EPA’s implementation of the Toxic Substances Control Act. 

Tens of thousands of chemicals are currently in commercial use 

in the United States, and over 700 new chemicals are introduced 

in commerce every year. Although these chemicals are unquestionably essential to produce important goods and services that we all 

enjoy, some may be toxic and may adversely affect human health 
5 

and/or the environment. It was in this context that Congress enacted TSCA in 1976, authorizing EPA to obtain information on risk 

of chemicals and to control those that pose an unreasonable risk. 

My testimony today is based on a report that we issued last year, 

but also on past and ongoing work we have done on TSCA. In summary, our work has shown that TSCA’s authorities for collecting 

data on existing chemicals do not facilitate EPA’s review process, 

primarily because the costly and time-consuming burden of producing chemical risk data is on EPA rather than the chemical industry. As a result, EPA has used its authorities to require chemical companies to develop data for only about 200 of the 62,000 

chemicals in commerce since TSCA was enacted in 1976. 

In addition, EPA has had difficulties in using TSCA to control 

the risks of specific chemicals. For example, in order to withstand 

judicial scrutiny, a TSCA rule to control chemical risk must be supported by substantial evidence that a given chemical presents not 

just a substantial risk, but an unreasonable risk to human health 

and the environment. In our view, this is such a high legal standard that it inhibits EPA’s ability to ban or restrict the manufacture 

or use of chemicals. In fact, EPA has issued regulations under the 

Act to ban or limit the production of only five chemicals in the 30 

years since TSCA was passed. 

Recognizing the need for additional information on existing 

chemicals, EPA implemented the High Production Volume challenge program, as you just heard, in the late 1990’s. Under this 

program, chemical companies agree to voluntarily provide test data 

on chemicals produced or imported in amounts of 1 million pounds 

or more per year. While the HPV challenge program is a laudable 

effort and has resulted, as you heard in EPA receiving information 

on 2,800 additional chemicals, EPA has not yet fully determined 

how useful the information it has obtained will be or what additional information may be required. 

Even with this additional data, EPA still needs to meet TSCA’s 

lofty standard of demonstrating in a costly and time-consuming 

rulemaking that a given chemical possesses unreasonable risk before it can take action. Similarly, EPA’s processes for reviewing 

new chemicals is cumbersome. TSCA does not require chemical 

companies to test new chemicals before notifying EPA of their intent to manufacture a chemical. And companies generally do not 

voluntarily perform such testing. 

To compensate for this general lack of data, EPA uses sophisticated scientific models to predict the potential exposure and toxicity level of new chemicals. However, these models are not always 

accurate predictors of risk. Additionally, estimates of the chemical’s 

production volume and anticipated use can change substantially 

after EPA completes its review. But the estimates do not have to 

be amended by companies unless EPA promulgates a significant 

new use rule. 

Mr. Chairman, while EPA’s efforts are commendable in encouraging companies to voluntarily provide data on existing chemicals, 

the Agency’s ability to manage its chemical review program and assess chemical risks are severely inhibited by TSCA’s cumbersome 

authorities. EPA could review substantially more chemicals in less 

time if some of the burden for assuring the risks of chemicals was 
6 

shifted from EPA to chemical manufacturers. In that regard, we 

have made several recommendations over the years for improving 

TSCA, such as giving EPA additional authority under Section 4 to 

require companies to develop test data based on production volumes and the potential risk of the chemical. EPA has begun to address some of our recommendations, but others require amendments to TSCA. 

Mr. Chairman, that concludes my summary of my statement. I 

will be happy to answer questions. 

Senator INHOFE. Thank you, Mr. Stephenson. 

Let me ask you a question. At the very last of your statement, 

you talked about the recommendation that you make to shift more 

responsibility back to the companies. When you make recommendations like that, do you take into consideration the costs that would 

be involved to the ultimate consumer of the chemicals? 

Mr. STEPHENSON. We do. And, we think the recommendations we 

have made fall in the modest category. I would say, that we would 

not require the chemical industry to produce data on all chemicals, 

only the few that aren’t the greatest risk. We subscribe to a riskbased approach, based on the volume of the chemical produced and 

other risk factors. 

Senator INHOFE. But you do consider that, then? 

Mr. STEPHENSON. Yes. 

Senator INHOFE. In a recent congressional staff briefing, the GAO 

stated that companies can claim any information they want as confidential business information and therefore be protected from public view. Yet the Section 8 requires companies to immediately submit information that reasonably supports the conclusion that a substance presents ‘‘a substantial risk of injury or health and the environment.’’ Do you see a conflict there? 

Mr. STEPHENSON. We think CBI claims are mostly legitimate. 

They are protecting proprietary information of the company. What 

we are subscribing is a broader use of even CBI information beyond 

EPA to other valid users. For example, the States may have valid 

reasons for seeing that data. Right now, it is not easily provided 

to them or other legitimate users because of limitation in TSCA. 

Senator INHOFE. I see. 

Mr. Gulliford, I took some notes at the very last of your statement. Because I didn’t get that from your submitted statement. Is 

it correct, you said since 1968, well, in 1968 there were some 

62,000 identified chemicals? 

Mr. GULLIFORD. That is the number of the chemicals that were 

immediately put on the list as existing chemicals. 

Senator INHOFE. As existing chemicals. Now it is almost, well, it 

is up another 45? 

Mr. GULLIFORD. We reviewed 45,000 new submissions. Roughly 

20,000 of those have gone onto the list. 

Senator INHOFE. Some people believe that TSCA is broken and 

that it doesn’t provide EPA the needed authority to gather the information necessary to adequately evaluate and regulate the harmful chemicals. You said it was very effective in your opening statement. Very briefly, I would just like to have you restate that, because I want to make sure we understand what your feeling is 

about their effectiveness. 
7 

Mr. GULLIFORD. We think TSCA is a very effective statute. It 

does give us the ability to assess the likelihood of risk during the 

introduction of chemicals into manufacturing or commercial processes here in this Country. We get good information. We have excellent models that allow us to determine whether or not there is 

a likelihood of an increased risk. TSCA gives us the authority to 

go to the companies and require additional information if we feel 

it is appropriate. We also have the authority, if the chemical appears to be a very safe chemical, to allow it to proceed immediately, 

which is good for industry and it is good for the environment. 

Senator INHOFE. Good. Just last week, the American Bar Association’s environment section released a paper that indicated the 

organization’s belief that TSCA currently provides sufficient legal 

authority to regulate nanoscale chemicals. Does EPA believe it has 

the authority it needs to address these chemicals? This is something people are concerned with today. 

Mr. GULLIFORD. We have examined the authorities very carefully, and we do believe and we agree that TSCA has and provides 

the authorities necessary to review both new and existing 

nanoscale materials for use in this Country. We are pleased that 

the American Bar Association came to the same conclusion. 

Senator INHOFE. All right, that is good. 

Let me at this point, I understand that Senator Lautenberg has 

to depart shortly. If it is all right with you, Senator Jeffords, we 

can go to him for his questions. 

Senator LAUTENBERG. Senator LAUTENBERG. I appreciate that very much, Mr. Chairman, and I know that you have a commitment that you must keep. 

What I wanted to get square, Mr. Gulliford, is whether or not, 

in your remarks you talked about the number of new things that 

have come up and have been reviewed. But since the passage of 

TSCA, only 2 percent of the chemicals that were in use at that 

time have been evaluated by the EPA. And only five of those have 

been regulated. In other words, we are talking about a base of 

62,000 chemicals. Are my statements, do they reflect the real condition? 

Mr. GULLIFORD. What the Agency has done is, we have looked at 

the number of chemicals that are in use in this Country, those that 

are used in the highest volume. And we went to the industry and 

asked for additional data on those high production volume chemicals. And in doing so, we have data actually on 93 percent of these 

actual chemicals that are in use or produced and used in this 

Country. And again, industry was very responsive. 

Senator LAUTENBERG. You are talking about a base of 62,000? 

Mr. GULLIFORD. That is right. Of those 62,000 chemicals, many 

of those chemicals are used in large volumes. Those are the ones 

that we went to, I believe it was 2,800 of those that are actually 

responsible for 93 percent of the chemistry or the chemicals that 

are produced in this Country. Those are the ones that we went to 

with the HPV challenge to get information, additional information 

on those chemicals. 

We have received that. In fact, we have received already to date 

97 percent of the information that was requested. We have reviewed those studies and are looking now on how to proceed for-
8 

ward to use that information. We have also made that information 

available for public on the web to allow any users access to that 

information. 

Senator LAUTENBERG. Fundamentally you are saying you cutoff 

your review at a particular volume of use? Does that include the 

toxicity of these things as well? Whether or not it is high volume 

or low volume, if it is terribly dangerous material, then even a low 

volume might—— 

Mr. GULLIFORD. We have opportunities to look at low volume 

chemicals, too, as I think was pointed out. Through the Section 8(e) 

requirements of TSCA, if an industry becomes aware that there are 

toxicity problems with the chemical, they must report that immediately. That has happened. We have had good examples of that. 

The PFOS reports that came to us. 

Senator LAUTENBERG. Are you satisfied with the progress that 

we have made since TSCA was put into law? 

Mr. GULLIFORD. Yes, I am. 

Senator LAUTENBERG. You really are? There are 82,000 chemicals currently in commerce. Are they all safe? 

Mr. GULLIFORD. There are different toxicities related to those 

chemicals. The information that we have States that in their production and in their use, the risks to the human health and environment is acceptable. 

Senator LAUTENBERG. Now, that, so you make that analysis regardless of what age the person who is exposed might be? I mean, 

if it is an infant or a child, doesn’t that cause a little more intensity 

of review? 

Mr. GULLIFORD. Yes, it does. In fact, we have a pilot program 

looking at the effect of chemicals on infants and children. We 

looked at 20 chemicals that were specifically chosen for their potential access to those chemicals to children. We are just now getting 

the data from that. We have been reporting it. We are about to 

issue a Federal Register notice asking for an evaluation of the information that we have learned about those chemicals. 

So we do have the ability to look specifically at chemistry, that 

is, specific to children. 

Senator LAUTENBERG. How many of these materials would you 

say that you have had a thorough enough review—how many have 

you discarded because of low volume of use, do you know? 

Mr. GULLIFORD. It is not our approach to discard any of the 

chemicals. 

Senator LAUTENBERG. I use the term loosely. Ignore. 

Mr. GULLIFORD. Well, in terms of new chemicals, as we review 

them, roughly 10 percent of the chemicals that come in are either 

voluntarily not chosen to be brought into production because the 

industry understands the risks associated, that our models have 

identified. We also place restrictions on a lot of the chemicals that 

have come. 

With respect to existing chemicals, again, we looked at those in 

the highest volumes of production, because again, they are likely 

then to either have manufacturing exposures associated with them 

or exposures in the actual use of those chemicals. So that is why 

we chose those as the appropriate first steps. 
9 

Senator LAUTENBERG. Mr. Chairman, with appreciation for the 

time, I would just like to ask that my full opening statement be included in the record. 

Senator INHOFE. Yes. 

Let me ask you, Senator, are you going to be able to come back 

at 3 o’clock and participate, in the event that the panelists are not 

through? 

Senator LAUTENBERG. Lord willing. 

[Laughter.] 

Senator INHOFE. I think the Lord is willing. 

[Laughter.] 

Senator LAUTENBERG. Thank you. 

Senator INHOFE. Your entire statement will be made a part of 

the record. 

[The prepared statement of Senator Lautenberg follows:] 

STATEMENT OF HON. FRANK R. LAUTENBERG, U.S. SENATOR FROM

THE STATE OF NEW JERSEY

Mr. Chairman, in 1962, a scientist named Rachel Carson published a book called 

Silent Spring. Silent Spring was a wake-up call to the American people. It warned 

us that many chemicals that were in widespread use at that time including DDT 

posed threats to our health, our environment, and to wildlife. In the aftermath of 

its publication, some dangerous substances, like DDT, were banned. 

And in 1976, Congress passed the Toxic Substances Control Act to protect us from 

dangerous chemicals in everyday consumer products. Unfortunately, since the passage of that law 30 years ago, we still don’t have adequate information about thousands of chemicals to which we and our children are exposed every single day. 

The American people should have a right to that information. But court rulings 

have limited the effectiveness of TSCA, and tied the hands of the EPA in its ability 

to evaluate the danger of chemicals in our environment. Since the passage of the 

TSCA, only two percent of the chemicals that were in use at the time have even 

been evaluated by the EPA. And only five toxic substances have been regulated. 

Meanwhile, we are constantly exposed to thousands of other chemicals that might 

or might not be safe. 

Last year the CDC issued a report evaluating the U.S. population’s exposure to 

148 chemicals. In samples of blood, urine and fat tissue, they found traces of all but 

two of those chemicals. Other studies have found hundreds of industrial chemicals 

in the umbilical cord blood of babies born in the United States 

Clearly, the health of our children is still at risk from exposure to industrial 

chemicals. That’s why I have introduced the Kids Safe Chemical Act, to update and 

strengthen the TSCA. Senators Jeffords and Boxer are co-sponsors. My bill would 

protect children by requiring manufacturers to provide health information to the 

Government before they distribute a chemical in consumer products. It would establish special safety standards for children, because they are especially vulnerable to 

toxic exposures. And it would say that if we aren’t certain that a chemical is safe 

we shouldn’t use our children as guinea pigs. 

I hope we can have a hearing on the Kids Safe Chemicals Act before Congress 

adjourns for the year, or early in the next session of Congress. The American people 

have already waited 30 years for this information. The time for delay is past. Now 

it is time for meaningful action. 

Thank you Mr. Chairman. 

Senator INHOFE. Senator Jeffords. 

Senator JEFFORDS. Mr. Gulliford, on March 6th, 2006, Donald Elliott, former EPA general counsel, appeared before the House Committee on Energy and Commerce. Mr. Elliott testified that EPA can 

no longer use TSCA Section 6 as a useful tool for regulating chemicals, because of the high evidentiary standard. Mr. Elliott stated, 

if after thousands of deaths from asbestos exposure EPA could not 

regulate asbestos under Section 6, it is virtually impossible for EPA 

to regulate any chemical under Section 6. 
10 

Is this correct? 

Mr. GULLIFORD. I am not familiar with that testimony, but Section 6 remains a very important portion of the TSCA statute to us. 

It clearly serves as a backstop to a lot of the work that we do and 

a lot of the interaction that we have with industry. The numbers 

are correct, and the decision on the Fifth Circuit Court did not sustain EPA’s position on the regulation of asbestos. Still, the presence 

of that statute, and we have initiated actions under that portion of 

the statute, has been very helpful in allowing us to come to agreement on voluntary actions on the part of industry to either remove 

chemicals from production or change the way that those chemicals 

are used. 

Senator JEFFORDS. Mr. Gulliford, in your testimony you discuss 

the High Production Volume initiative as a voluntary mechanism 

for getting health and safety data on chemicals that are produced 

at quantities over 1 million pounds annually. Yet the President’s 

proposed budget would cut $2.2 million from this program and dramatically restricts EPA’s ability to review the data voluntarily provided. 

What steps are you taking to ensure that this voluntary information is expeditiously reviewed, so that potential public health dangers can be quickly identified? 

Mr. GULLIFORD. Several things. First of all, one of the best things 

we did was we made all of this information public. So not only does 

the Agency have access to it, but so do any other organizations in 

Government or the private sector will have, certainly, input from 

them as to how they interpret the information that is there, as well 

as their own scientists’ review of it. I think the information will get 

a very careful screening and it will allow us to again select from 

that, on the basis of that, any chemicals that we believe are appropriate to follow up with in more detail. 

Senator JEFFORDS. Mr. Stephenson, in EPA’s statement, the 

Agency emphasized that they have initiated voluntary programs, 

such as the High Production Volume challenge program, in order 

to gather information on chemicals that generally were already in 

commerce when TSCA was enacted. Will the program be effective 

in assisting the Agency in its regulatory rule? 

Mr. STEPHENSON. We are supporters of the HPV or any other voluntary program, because it provides additional data which would 

otherwise be difficult to get under the TSCA authorities. The problem is that it is basic screening level data. 

Now, I just heard today that they have asked for additional exposure data, which is a good thing. But we don’t think the data is 

sufficient enough to do the analysis to determine the risk of chemicals at this point. There is a lot of analysis that needs to be going 

on. While this HPV program came into place in 1990, data is still 

coming in. There is still data on 250 plus chemicals that has not 

come in. 

So it is too soon to tell how useful this information will be. This 

does not negate the need for making TSCA easier to use, in our 

opinion. 

Senator JEFFORDS. Thank you. 

Senator INHOFE. Senator Carper, would you like to be recognized 

for questions? 
11 

Senator CARPER. Not at this time, thanks. 

Senator INHOFE. We are about through with this panel. 

Senator CARPER. Let’s let them go. 

Senator INHOFE. All right. I have one last question, Mr. 

Gulliford. As we all know, the testing for pesticides and food additives are in a different statute. Would you kind of explain the reason behind that and the different types of testing that you have 

under TSCA, as opposed to the statutes that regulate pesticides 

and food additives? 

Mr. GULLIFORD. Yes, thank you, Mr. Chairman. The TSCA and 

the FIFRA statutes are two fundamentally different statutes, fundamentally different approaches to regulation. In fact, FIFRA acts 

as a licensing agent or a licensing process for pesticides, which we 

generally assume to have active ingredients and to be biologically 

active. 

Therefore, we ask for the information necessary to determine 

what the likely impacts of those actions might be on biological communities or human health, as well as the environment. So we do 

ask for very specific data to enable us to make those judgments, 

make those decisions relative to FIFRA and pesticides. 

TSCA, on the other hand, deals with industrial chemicals. They 

are not designed for food purposes or food uses. So we place in effect through TSCA an assessment process to measure the potential 

risk that those chemicals may have, either through their manufacture or through their use in commerce. Then we use that information to determine whether or not there is a probable risk to human 

health or the environment. And then given when we find that, we 

can take an action then to appropriately either gain additional information necessary to regulate those uses or to regulate on the 

basis of the information that we have. 

So they are very fundamentally different statutes for very different purposes. 

Senator INHOFE. Thank you for that distinction. 

Mr. Gulliford, Mr. Stephenson, thank you very much for being 

here. Let me just say that there will be questions for the record. 

Also there will be statements, opening statements, that will be submitted for the record for those that didn’t have a chance to do it. 

We would ask that you review those when you receive them. Thank 

you very much for your appearance. 

We will call up the second panel. Before we do, I would like to 

recognize Cori Lucero. Cori, stand up, hold your hand up there, let 

them see who you are. This is going to be her last hearing. She has 

been with us for a couple of years now. We were expecting she 

would be here a lot longer than that, but she has better things to 

do, I guess. 

[Laughter.] 

Senator INHOFE. She has done a great job, and she is going to 

be replaced by Steve Chapman over here. Steve, you smile too 

much for that job. You have to be mean. 

[Laughter.] 

Senator INHOFE. Cori, you have done a great job, you really have. 

It has been a joy having you around. Thank you. 

Senator Carper, we checked with staff, there was an unfortunate 

death and the funeral takes place at 11 o’clock today. So we had 
12 

planned to go ahead with our witnesses and then come back at 3 

o’clock, take a recess at 11 o’clock and come back at 3 o’clock. If 

you would be able to do that, in your schedule, that would be great. 

We will see how far along we get between now and 11 o’clock. 

Senator CARPER. We have a markup in my Banking Committee 

at 10 o’clock, and they have asked us to come, so I am going to slip 

out for a while, but I will come back. 

Senator INHOFE. Yes. All right. I understand that. 

Our next panel is William Rawson, the Chair, Environment, 

Land and Resources Department, partner in Latham and Watkins; 

Lynn Goldman, Johns Hopkins University, Bloomberg School of 

Public Health; Michael Walls, Managing Director of Regulatory and 

Technical Affairs, American Chemistry Council; Michael Wilson, 

Center for Occupational and Environmental Health, School of Public Health, University of California, Berkeley; and Gail Charnley, 

President, HealthRisk Strategies. 

So in that order, we will start with opening statements, with you, 

Mr. Rawson. And we would like to ask you to try to stay within 

your timeframe, all five of you. Then we will proceed to questions. 

Your entire statements will be made part of the record. 

Mr. RAWSON. 

STATEMENT OF WILLIAM K. RAWSON, PARTNER AND CHAIR 

OF THE ENVIRONMENT, LAND AND RESOURCES DEPARTMENT, LATHAM AND WATKINS 

Mr. RAWSON. Mr. Chairman, distinguished members of the Committee, and staff, good morning. 

I would like to begin by thanking you for giving me the opportunity to speak this morning and to contribute to the public discourse on the Toxic Substances Control Act. I hope that my written 

and oral testimony will prove useful. 

The question before the Committee today, at least in part, is 

whether the provisions of TSCA give EPA the authority it requires 

to meet the objectives set forth in the Act. I believe the answer to 

that question is yes. In my judgment, TSCA is a well crafted statute that has stood the test of time well. 

My written testimony focuses on three sections of the statute, 

Section 5, pertaining to the review, testing and control of new 

chemicals, Section 4, pertaining to the testing of existing chemicals, 

and Section 6, pertaining to the regulation of existing chemicals. In 

my oral testimony, I will just speak briefly to a few key points. 

Before I do that, I would like to express my personal strong support for EPA’s mission. I have worked with many EPA managers 

and staff over the years, very closely, on a number of very challenging issues. And I have great respect for their efforts in support 

of the Agency’s mission. 

With respect to the regulation of new chemicals, the strength of 

TSCA lies in its flexibility. Section 5 gives EPA the flexibility to 

vary its assessments of new chemicals according to the attributes 

and expected uses of each substance. 

The majority of new chemical substances pose little or no risk to 

health or the environment, and either qualify for an exemption 

from the pre-manufacture notice requirements or are readily determined to have low toxicity, based on information submitted with 
13 

the PMN, use of EPA models, and comparison to previously approved chemicals. 

Where appropriate, however, Section 5 does give EPA authority 

to prohibit or limit the manufacture and use of new chemicals. EPA 

has used this authority provided under Section 6 to compel testing 

for many new chemical substances and also to impose restrictions 

or controls. In fact, EPA has imposed substantial controls on or effectively prohibited the manufacture of more than 3,500 chemical 

substances since TSCA was enacted. 

Thus, in my judgment, the provisions of Section 5 appear well 

designed to achieve congressional intent. EPA has the necessary 

flexibility and discretion to give each new chemical substance the 

level of scrutiny it merits and to impose such restrictions on manufacture and use as are necessary to prevent unreasonable risks to 

health and the environment. 

Section 4 grants EPA the authority to require testing of existing 

chemicals. EPA has required testing of more than 200 substances 

under Section 4 and many more substances have been reviewed 

and determined to be a low priority for testing or not to require 

testing at all. Also as described in the earlier testimony, a large 

number of chemicals have been tested under voluntary programs 

by industry. 

There has been some suggestion that the findings required by 

Section 4 are overly burdensome on EPA, thus rendering Section 

4 ineffective. I personally find these arguments unpersuasive. In 

my judgment, EPA’s burden to support a test rule in fact is quite 

modest. EPA only needs to show that a chemical may present an 

unreasonable risk or that it may be released to the environment in 

substantial quantities, or that there is or may be significant or substantial human exposure. And the threshold for making those findings in fact is quite low. 

That said, I do believe EPA could improve its performance under 

Section 4 in a number of ways. Relatively few test rules have been 

issued in recent years. I realize that is in part because of the substantial effort devoted to the HPV challenge program. It is also the 

case that a number of testing proposals have languished unfinished 

for extended periods of time. In my written testimony, I have offered some specific suggestions for how implementation of Section 

4 might be improved. But I do not believe the statutory criteria 

need to be modified. In my judgment, they provide a sound scientific basis for making appropriate testing decisions. 

Section 6 gives EPA authority to regulate existing chemicals. The 

EPA used this authority effectively in the early days of TSCA to 

in fact regulate several substances under Section 6. But as has 

been noted, EPA’s authority under Section 6 and the effectiveness 

of that Section has been called into question by the decision in Corrosion Proof Fittings. In that case, the court struck down EPA’s 

ban on certain asbestos-containing products. 

The failures in the asbestos rulemaking, however, in my judgment, were failures in implementation and do not reflect deficiencies in the statute. As the court explained in its decision, EPA’s 

product-specific bans in that case were rejected, because EPA specifically in that rulemaking used flawed procedures and flawed 

methodology. The details are set forth in my written testimony. 
14 

I say this not to be critical of the Agency, but because I think 

it is important that the decision not be misunderstood. In my judgment, the lesson of Corrosion Proof Fittings is not that Section 6 

does not work or cannot work. Rather, the lesson is that no matter 

what the product, when acting under Section 6, EPA of course 

must use proper procedures, consider relevant factors and provide 

an adequate explanation for its decision. The Agency does that, in 

my judgment. Section 6 can and will work, as it did several times 

during the early days of TSCA, and the Agency’s decisions will receive deferential treatment by the courts. 

In my judgment, GAO’s revisions to Section 6 are not necessary 

to support effective regulation, nor would they improve, in my judgment, the statutory framework for making regulatory decisions. 

Senator INHOFE. You will have to wind up, Mr. Rawson. 

Mr. RAWSON. Thank you. 

So in conclusion, I would just like to say that the Agency has accomplished a great deal under TSCA since its enactment. While 

there is always room for improvement, I do not believe that amendments to TSCA are required. I believe TSCA does provide EPA 

with ample authority to meet the objectives of the Act. 

Thank you. 

Senator INHOFE. Thank you, Mr. Rawson. 

Ms. GOLDMAN. 

STATEMENT OF LYNN R. GOLDMAN, M.D., M.P.H., PROFESSOR, 

ENVIRONMENTAL HEALTH SCIENCES, JOHNS HOPKINS UNIVERSITY, BLOOMBERG SCHOOL OF PUBLIC HEALTH 

Dr. GOLDMAN. Thank you very much. I very much appreciate, 

Mr. Chairman, the opportunity to testify before your Committee 

today, and I have submitted my full testimony for the record. I am 

going to give a very brief summary of it. 

As you probably are aware, I am a pediatrician by training. I 

served for more than 6 years as the Assistant Administrator for 

Prevention, Pesticides and Toxic Substances at the U.S. EPA. So 

in that position, I was responsible for the implementation of the 

Toxic Substances Control Act. I hope I can give you some insights 

that are more kind of from the inside, how it really works when 

you are trying to make this law work, which of course as a public 

health professional I was very committed to doing. 

I should say in opening that I have a tremendous amount of respect for the U.S. chemical industry. It is very important to our 

economy, and it is important to our way of life. And as a former 

regulator, that is something that one does not take lightly. I also 

have a tremendous amount of respect and admiration for the people who work at the EPA. I worked with people there who were 

highly trained professionals, very committed, and did the best that 

they could do. But unfortunately, they have not been given the 

tools nor the resources that they need to do their jobs properly. 

There is so much in my written testimony that I can barely cover 

it in the space of 5 minutes. So what I am going to do is very briefly touch on the nine areas that I think are of concern, the first 

being the area of risk evaluation. We believe as a society we should 

base our decisions on risk. To understand risk, you need to understand hazards and exposure, and TSCA tells us about neither. 
15 

The second area is protection of vulnerable populations. Can we 

adequately protect children and other vulnerable populations? 

TSCA has no provisions, unlike most modern environmental statutes, for doing so. 

The third area is risk management, can we manage risks under 

TSCA? And the answer is, no, we cannot. Despite what you may 

hear from others, the ‘‘least burdensome’’ requirement is too high 

a hurdle; he professional attorneys, scientists, economists within 

EPA recognize that this burden is too high. That is why there are 

no Section 6 rules on the books since Corrosion Fittings. 

The fourth area is one of precaution. Does TSCA allow us to take 

precaution? The answer is no. Because the standard of unreasonable risk does not tilt enough toward protection of health and the 

environment. 

Area No. five is assessment of new chemicals. There are great 

people in the New Chemicals office, and they make a great effort. 

The tools are insufficient. Structural information and use of computer modeling misses a lot of chronic risks. Studies have shown 

this. We know that this is not an adequate way of assessing the 

risks. 

Sixth is right to know and problems with TSCA’s confidential 

business information provisions. While CBI protection is very important, these provisions allow you to claim as CBI the name of the 

chemical and where it is made: even the States can’t find that out. 

As an ex–State official, (I worked in public health for the State of 

California.) I find this to be unacceptable. When I was at EPA, I 

could not tell a State environmental official what was in that CBI 

information. 

Seventh is pollution prevention. TSCA does not contain provisions to promote the development of new and safer alternatives. 

Eighth in the area of international management of chemicals, 

EPA has slipped in its leadership in the international arena. We 

are not a part of the POPS nor the PIC convention. And this is of 

great concern, not only from the standpoint of protection of health 

and the environment, but also for our economy. Our position of 

leadership in the world and the view that others in the world have 

of our products, the credibility of our process is at risk because we 

are not full participants in these foray. 

Ninth is that TSCA does not establish clear priorities for EPA in 

regulating toxic chemicals. 

In conclusion, I believe that overhaul of TSCA is long overdue. 

It has been 30 years since Congress enacted it. It has never been 

reauthorized. I think that the bills that are going through State 

legislatures to ban individual chemicals are a very bad symptom, 

along with the fact that EPA is falling behind globally. Further, 

procedures for new chemicals are not adequate. Even though EPA 

has the authority to regulate nanotechnology, how do the old QSAR 

(Quantitative Structure Activity) models apply to nanotech? They 

don’t at all. 

Of fundamental importance as well as the credibility and trust 

in the Federal process. If States are moving out on their own, I 

think that that speaks for itself. 

I also know, from my experience as a regulator, that one should 

not undertake such an overhaul without a process that brings all 
16 

the parties together. And I want to go back to my first point about 

the deep respect that I have for the U.S. chemical industry. Industry has a role to play, along with environmental groups, public 

health people, chemical experts. There needs to be a process, much 

like the process that the European Union has gone through, to define, what chemical regulation for the 21st century should look like 

in the United States? 

Thank you. 

Senator INHOFE. Thank you, Dr. Goldman, for an excellent, wellthought and organized statement. 

Mr. WALLS. 

STATEMENT OF MICHAEL P. WALLS, MANAGING DIRECTOR OF 

REGULATORY AND TECHNICAL AFFAIRS, AMERICAN CHEMISTRY COUNCIL 

Mr. WALLS. Good morning, Mr. Chairman, Senator Jeffords. 

Thank you very much for the opportunity to be here. 

We appreciate this opportunity to reiterate the U.S. chemical industry’s belief that the Toxic Substances Control Act provides a 

strong, robust regulatory framework for health and environmental 

protection in the United States. 

The member companies of the American Chemistry Council are 

on the cutting edge of technological innovation and progress. Our 

products provide safe drinking water, life-saving medicines, a safe 

food supply and jobs throughout the Nation. Our member companies are committed to the safe management and use of their products through compliance with TSCA, other U.S. Federal statutes 

and their own product stewardship initiatives. 

We have three major points to make today. First, innovation 

starts in the chemical industry. It is critical that the U.S. chemical 

regulatory framework continue to promote innovation and the technological prowess that has characterized our industry. 

Second, our industry invests billions in research and development in health, safety and environmental protection even before 

our products reach the market. That investment must be protected 

by a strong regulatory framework. 

Third, as science and technology develop, new questions will 

arise about hazards, exposures and risks to chemicals. It is vital 

that the U.S. chemical regulatory framework be robust enough to 

address those future concerns. 

In our view, TSCA meets each and every one of these objectives. 

The statute itself has proven effective and remarkably adaptable to 

changing needs and priorities. TSCA works, and it works well, and 

the facts support that conclusion. 

TSCA allows the Government to obtain information on unreasonable risks, assess that information and take appropriate action to 

address them. It empowers EPA with considerable authority, even 

the authority adopt non-regulatory programs that complement its 

policy objectives. 

TSCA has helped establish EPA as a global leader in developing 

tools and programs to understand more about chemicals faster 

than ever before. EPA developed and spread the introduction of 

predictive tools, like structure activity relationship analysis and 

other predictive models. EPA has pioneered time, money and ani-
17 

mal saving techniques, such as category approaches. These are also 

tangible measures of EPA’s success under TSCA. 

TSCA fuels innovation. More new chemical applications are filed 

under TSCA than under any other chemical regulatory system. The 

industry spends more than $23 billion a year on research and development. Technology is a driving force in our industry, and even 

as high natural gas prices affect jobs and profitability in our industry, we continue to invest in the future. 

My second point is that the industry’s significant investment in 

health, safety and environmental measures should be protected by 

a strong but flexible regulatory system. TSCA, as you heard, protects appropriate claims of confidential business information and 

strikes a balance between the industry’s interests in competitive information and the public interest in oversight of EPA’s TSCA activities. 

Moreover, that framework under TSCA has allowed the industry 

to bring forward a considerable amount of information resident in 

company files. You heard about the High Production Volume chemical program already from a number of other witnesses. The important point with the HPV program is that the TSCA framework has 

allowed the chemical industry to be responsive to concerns about 

chemical hazards, uses and exposures, even without a regulatory 

mandate. 

My final point is that the chemical regulatory framework must 

be robust enough to deal with future challenges. In this respect 

again TSCA meets the test. Concerns about children’s health, biomonitoring information and nanotechnology not only can be addressed under TSCA, they are being addressed. EPA has the appropriate authority to require new information about risks, to promote 

research or to require testing or even to craft new pilot programs 

on issues like nanotechnology. 

Has the chemical industry always agreed with EPA on its implementation decisions under TSCA? Clearly, that has not been the 

case. Do we agree that there are areas where EPA’s implementation of the statute can be improved? We surely do. We welcome the 

dialog on how to improve understanding about chemicals and ensure that EPA can implement its statutory authority. We have a 

track record of dialog with the Agency on these issues, as well as 

with other stakeholders. And that, I submit, is also evidence that 

TSCA works and it works well. 

Thank you for the opportunity to reflect our views on TSCA. I 

will look forward to your questions. 

Senator INHOFE. Thank you, Mr. Walls. 

Dr. WILSON. 

STATEMENT OF MICHAEL P. WILSON, PH.D., M.P.H., 

UNIVERSITY OF CALIFORNIA, BERKELEY 

Mr. WILSON. Mr. Chairman, members of the Committee, thank 

you very much for inviting me to the hearing today. I am an Assistant Research Scientist at the University of California Berkeley, 

and I am the lead author of the U.C. report to the California legislature entitled Green Chemistry in California: A Framework for 

Leadership in Chemicals Policy and Innovation. 
18 

The report illustrates that California, like other States, is facing 

an array of chemical problems. On the other hand, the report finds 

that a modern chemicals policy that responds to these problems 

has the potential to deliver an extraordinary set of benefits to the 

public and to businesses. It could build the foundation for a sustainable chemical industry, it could prevent costly chemical damage, and it could position the United States to become a global 

leader in green chemistry, the design, production and use of chemicals that are inherently safer for human health and the environment. 

Crafting a modern chemicals policy of this type will require that 

we correct longstanding deficiencies in the Toxic Substances Control Act. The report summarizes the results of several important 

analyses that have all reached the same conclusions about the deficiencies in TSCA. Our report points out that these deficiencies have 

produced a flawed chemicals market in the United States that has 

on the one hand allowed the producers of hazardous chemicals to 

remain competitive in the market, and on the other, has dampened 

motivation of the industry and entrepreneurs to vigorously invest 

in green chemistry technology innovation. 

The report describes a data gap, a safety gap and a technology 

gap that have emerged in the U.S. chemicals market as a result 

of TSCA. The data gap refers to the lack of information in the market on the safety of chemicals. TSCA does not require producers to 

generate and distribute adequate information on the safety of their 

products. Markets cannot function efficiently without information, 

and the chemicals market is no exception. 

The safety gap refers to the well-documented barriers that EPA 

faces in its efforts to assess the hazards of chemicals and control 

those of greatest concern. The technology gap refers to the potential for the United States to fall behind globally in the development 

of green chemistry technologies. 

Mr. Chairman, a properly functioning chemicals market would 

amplify the positive contributions of the chemical industry to our 

society, while steadily reducing its negative impacts. It is widely 

recognized that the chemical industry generates extraordinary benefits to our economy and to our modern way of life. Yet over the 

next 25 years, we will spend up to $250 billion cleaning up hazardous waste sites, a portion of which are attributable to chemicals. 

This year alone, some 23,000 Californians will be diagnosed with 

a deadly chronic disease attributable to chemical exposures on the 

job. 

The effects of exposures that occur during fetal and child development are of course of great concern. It makes sense to prevent 

these negative impacts and motivate the industry to focus its enormous talent on the design and production of safer chemicals, on 

green chemistry. This will require that we close the data and safety 

gaps through a fundamental restructuring of TSCA. 

We can close the data gap by requiring chemical producers to 

generate and distribute information on the safety of their products. 

We can close the safety gap by providing Government with better 

tools to efficiently evaluate chemicals and reduce the commercial 

circulation of the most dangerous ones. These steps alone will cre-
19 

ate a market that favors investment in green chemistry, which will 

gradually close the technology gap. 

We can go further by offering a range of incentives to companies 

that implement green chemistry solutions, and we can fund green 

chemistry research and education. This will support our leading 

companies, it will save us enormous public health expenditures, 

and it will put us at the forefront of global developments in green 

chemistry. 

Our report recommends the importance of bringing Government, 

industry, advocates and the scientific community together into a 

task force to identify and prioritize and frame a chemicals policy 

in California. 

Mr. Chairman, members of the Committee, thank you very much 

for your attention today. And thank you again for inviting me to 

this important hearing. I am pleased to answer any questions you 

might have. 

Senator INHOFE. Thank you, Dr. Wilson. 

Dr. CHARNLEY. 

STATEMENT OF GAIL CHARNLEY, PH.D., PRESIDENT, 

HEALTHRISK STRATEGIES 

Ms. CHARNLEY. Chairman Inhofe, other Senators, thank you for 

the opportunity to speak with you this morning. I am basing my 

statement on 30 years of experience as a toxicologist and risk analyst studying the relationships between chemical exposures and 

public health outcomes. 

In its 1997 final report, the bipartisan Presidential-congressional 

Commission on Risk Assessment and Risk Management, for which 

I served as executive director, recommended a sustained stakeholder process should be initiated to review TSCA and its implementation. As Administrator Gulliford has pointed out this morning, a variety of activities has taken place since then that is consistent with the commission’s recommendation, such as the establishment of the National Pollution Prevention and Toxics Advisory 

Committee, the High Production Volume challenge program, and 

the new extended program in the Voluntary Children’s Chemical 

Evaluation program. 

I believe that those programs demonstrate that voluntary, multistakeholder initiatives are both possible and succeeding under the 

umbrella of TSCA. 

Basic toxicity data have been generated for most of the chemicals 

in commerce by volume, and research efforts have provided information about children’s exposures and susceptibilities that is incorporated into risk assessment and chemical standard setting. These 

efforts continue to generate data that will contribute to better and 

better chemical regulation and to safer, healthier children. 

To the extent they are available, environmental and bio-monitoring trend data demonstrate that overall, emissions and body 

burdens of chemical contaminants in the United States continue to 

decline. While the public is understandably concerned about the detection of chemicals, bio-monitoring data that provide information 

solely about trace levels of substances in blood or urine cannot be 

used to draw conclusions about the likelihood of disease, except in 

very rare cases. 
20 

Exposure does not imply toxicity, and presuming that any chemical exposure is dangerous and that any chemical hazard poses a 

risk is inappropriate and not supported by science. The dose makes 

the poison, after all. In addition, focusing solely on the presence of 

trace levels of chemicals misses the substantial contributions that 

genetics and economics, social, cultural, behavioral and psychological factors contribute to risk. 

Furthermore, current EPA methods for setting standards to limit 

chemical exposures are precautionary, and account for the possibility that children can be more susceptible than adults to chemical 

toxicity. If no data are available with which to evaluate risks to 

children, standard practice is to use extra safety factors that make 

exposure limits more stringent. If data are available with which to 

evaluate risks to children, those data are considered as part of the 

standard setting process. 

The HPV chemical testing program convened under TSCA uses 

a tiered approach to testing. The advantage of the tiered testing 

approach is that it helps identify early on those chemicals that are 

more likely to pose a particular risk to children than others, so that 

those chemicals get higher priority testing at the next year. My 

point is that although, that through the HPV and Voluntary Children’s Chemical Testing programs, both convened under the umbrella of TSCA, there is a big focus on identifying chemicals that 

might pose a particular risk to children and in any case, when EPA 

restricts chemical exposures, it errs on the side of precaution to 

protect children and other potentially vulnerable people. 

Finally, our environment is cleaner and our food and water is 

safer and people are healthier than ever before. Our environmental 

programs are evidently working overall. Even the New York Times 

noted on Sunday that people alive today in developed countries are 

healthier than they used to be, live longer, get heart disease and 

other chronic illnesses later in life than they used to, experience 

less disability and have higher IQs Those improvements are attributed to much-improved maternal and childhood health. 

While I think that testing chemicals and regulating chemical exposures are certainly very important, I think our obsession with 

trace contaminants is out of proportion to their likely public health 

risk. And I think it would be nice if we recognized our environmental accomplishments. 

Thank you. 

Senator INHOFE. Thank you, Dr. Charnley. 

Let me start off, Dr. Goldman, you have suggested that the High 

Production Volume production is inadequate and that we need 

more aggressive testing. Would this be testing that would involve 

lab animals? What type of testing are you referring to? 

Dr. GOLDMAN. In terms of the High Production Volume chemical 

program, when I was at the EPA I was among those who brought 

the parties together to create the agreement to do the program. I 

am very much in support of it. I think that we definitely need 

screening level information on the chemicals in highest production 

in the Country. 

But we need to keep it in perspective. It is only screening data. 

If I am taking care of you, if you were my patient, and I did this 

screen on you—— 
21 

Senator INHOFE. No, let me just ask you to get right to the answer. Would it require more lab animal testing in order to be more 

aggressive? 

Dr. GOLDMAN. You need to have a process first that tells you 

which findings from the screening indicate that there is a risk. And 

then, based on that, you gather further information, which may or 

may not be information derived from examinations in animals. It 

might lab animals, it might involve other kinds of data gathering, 

depending on what the results of the screening show. 

Senator INHOFE. OK. The reason I am asking the question, we 

have had several hearings now, I think a lot of people are not 

aware that the No. 1 and No. 2 domestic violence, according to the, 

I am not sure who made the evaluation, I guess it was the Department of Homeland Security, is some of the animal rights groups. 

We have had several Committee hearings on this, where they have 

come in and talked about actually encouraging people to murder 

people that are testing, using animals to test. 

It has been really a pretty tough thing to deal with. So I just 

want to keep that in mind, because we do have a real serious problem there that we have been trying to address. 

Dr. Charnley, you made a statement, and I think it is worth 

elaborating on a little bit. You said the dose makes the poison. 

There are a lot of people who believe just the chemical alone is 

something that is the problem. There is a chart up here, I was 

going to use this in my opening statement, I didn’t get a chance 

to do it. This chart is a children’s multi-vitamin chart. It shows, for 

example, copper, which is essential for forming red blood cells and 

boost the body’s ability to mend tissue. Copper is regulated as a 

secondary drinking water contaminant. Or Vitamin D, an important nutrient added to milk. Too much Vitamin D may lead to kidney stones, high blood pressure, et cetera. 

As a toxicologist, does science support the assumption that any 

chemical exposure is dangerous? I would assume not. 

Ms. CHARNLEY. That is correct, no, sir, it does not. As I pointed 

out in my testimony, the dose does make the poison. At the right 

doses, vitamins and aspirin might even make you feel better, but 

they won’t harm you. If you take too much of them, then they will 

make you sick. 

Basically the same is true for chemicals. As the CDC States, the 

presence of a chemical in a blood or urine specimen does not indicate a chemically caused diseases or risk. 

Senator INHOFE. I think that is worth bringing out, because so 

many people are of the opinion that if it exists at all, that that 

alone is dangerous. 

Mr. Rawson, under Section 6, the EPA has to show that it is 

using the least burdensome requirement, least burdensome requirement. Now, some people have argued here on this panel that 

we need a lower standard. I would ask you if you consider that to 

be a very difficult requirement for the EPA to meet, least burdensome requirement. 

Mr. RAWSON. I consider it a reasonable standard. I think it is 

reasonable to expect the Agency to consider alternative approaches 

and to choose the approach that does protect health and the environment, but while imposing the least burdensome requirements. 
22 

And stated differently, if something less than a ban will do the job, 

then I think EPA should use it. I will just add quickly, that is what 

happened with acrylamide grout. EPA proposed a ban under Section 6, based on a concern for worker exposure. And the industry 

came forward and developed a new type of personal protective 

equipment that eliminated the concern. Therefore, the rule, the 

proposal was withdrawn. But to me, that is a win-win under Section 6, even though no final action was taken, because a less burdensome approach solved the problem than the proposed ban. 

Senator INHOFE. Dr. Goldman, the reason I brought that up, 

PETA has stated that for each chemical that it would take about 

9,000 lab animals per chemical. I don’t want you to answer now, 

but for the record, I would like to get into this thing as to how 

more aggressive testing could take place without that, or be a little 

more specific on that. Because this is a problem we are dealing 

with quite a bit. 

Senator JEFFORDS. 

Senator JEFFORDS. Dr. Goldman, you were involved in the Johns 

Hopkins study that evaluated the exposure of babies to certain industrial chemicals. How did the findings of this study support your 

testimony in favor of TSCA requiring the protection of sensitive 

populations, especially children? 

Dr. GOLDMAN. We are still involved in this work. What we find 

is many, many industrial chemicals that are in the cord blood of 

babies when they are born. For most of these, we have no information in the toxicology or the epidemiology literature about what 

they are doing to children. And as concerned as I am about animals, and by the way, the 9,000 number is a gross exaggeration—— 

Senator INHOFE. I agree. 

Dr. GOLDMAN. I am very concerned about children. And I don’t 

think children should be our test species for chemicals. We should 

know before we are exposing our children to chemicals what those 

chemicals may do to them. 

Senator JEFFORDS. Dr. Charnley, in your testimony you claim 

that children are not more susceptible to chemical toxicity than 

adults. How can you reconcile this conclusion in light of the fact 

that children, pound for pound, breathe more air, drink more water 

and eat more food than adults and thus are more exposed to whatever toxins are present in the media? 

Ms. CHARNLEY. First of all, I did not say that children are not 

more sensitive. I think that children of course are probably in most 

cases more highly exposed. But I think that as to vulnerability, 

they can be either less than, more than or the same in terms of 

vulnerability, depending on the chemical and the exposure situation. 

When EPA regulates a chemical for which toxicity information 

about children’s sensitivity is available, then they use that information when they set chemical standards. If it is not available, 

then EPA uses more stringent approaches in order to protect children and other potentially vulnerable populations. 

Senator JEFFORDS. Dr. Wilson, in your testimony you noted that 

TSCA has created data, safety and technology gaps in the U.S. 
23 

chemicals market. Can these gaps be adequately addressed by the 

States or is a Federal overhaul of TSCA necessary? 

Mr. WILSON. I think an overhaul of TSCA is necessary. At this 

point in the State of California, for example, there is no State 

Agency that knows, has information on the identity of chemicals 

that are being introduced into commercial circulation in the State, 

where those chemicals are being used and in what volume, by 

whom, for what purpose or how people might be exposed. That presents a fundamental barrier to the States in terms of prioritizing 

and acting on chemical hazards. I think as Dr. Goldman mentioned, what we are seeing in California, last year it was 35 bills 

introduced into the legislature to address chemical-related problems. It is a symptom in a way of the lack of information that our 

State agencies have. What is needed, as I said, is an overhaul of 

TSCA that can get that information out to the States, so that we 

can act appropriately. 

Senator JEFFORDS. Mr. Walls, the Kids Safe Chemical bill that 

I drafted with Senator Lautenberg would require manufacturers to 

certify that their products meet the bill’s safety standard or that 

they do not have enough information. Does the chemical industry 

support this public right to know provision? 

Mr. WALLS. Senator, we do not support the Kids Safe Chemicals 

legislation that you introduced. We believe that under the Toxic 

Substances Control Act, EPA has sufficient authority to address 

children’s health issues. 

I should also note that children’s health issues are a priority for 

our industry. Our industry stepped up, volunteered to participate 

in the Voluntary Children’s Chemical Evaluation program in order 

to help us and to help EPA understand exactly what are the potential children’s exposures to chemicals and how we can properly assess those exposures and take some decisive action. As you heard 

from Mr. Gulliford, EPA intends to very soon issue a Federal register notice on an evaluation of that program, so that we can start 

to apply it on a broader basis. 

Senator JEFFORDS. Thank you. 

Senator INHOFE. Thank you, Senator Jeffords. 

Senator THUNE. Senator THUNE. Thank you, Mr. Chairman. I want to thank the 

panel for your testimony and for your input and for being here 

today and responding to questions. 

I would like to direct a couple of questions, if I might, to Mr. 

Rawson. First question would be this: was TSCA designed to eliminate all risks, in your judgment? 

Mr. RAWSON. No, Senator. We do not live in a zero-risk world. 

TSCA is designed to eliminate unreasonable risks. 

But I would like to point out that that is a very health protective 

standard. Because when EPA evaluates risk, it uses a very conservative approach, both in assessing intrinsic hazard and assessing exposure. Typically EPA will assume worst case exposure. So 

for example, lifetime use of a product or spending 70 years at the 

fence line of the highest emitter. 

On the hazard side, EPA will use uncertainty factors and will assume that humans are more sensitive than animals and that some 

humans are more sensitive than others. So typically, EPA will not 
24 

be satisfied unless maximum theoretical exposures are 100-or 

1,000fold below levels at which no effects have been seen in animals. 

I do want to emphasize that there is considerable health protective assumptions built into the unreasonable risk standard. 

Senator THUNE. You in your testimony indicated that it would be 

impractical to treat all chemicals alike during the review process. 

Could you elaborate on that a little bit? 

Mr. RAWSON. Yes, Senator. Very simply, not all chemicals are 

alike. EPA has indicated that a majority of new chemicals that are 

presented to the Agency through the pre-manufacture notice process are readily set aside based on screening information, comparison to previously approved chemicals, use of EPA models and the 

like, which I think are quite sophisticated and quite adequate. 

There are of course some chemicals that require closer scrutiny. 

That is where Section 5(e) comes into play and EPA’s authority to 

compel testing or to impose restrictions or controls. So I think that 

it is appropriate to recognize, as TSCA does, that not all chemicals 

are alike, and to give EPA the flexibility to devote extensive resources where appropriate and not where not appropriate. It is important to emphasize that if we took a one size fits all approach, 

EPA would end up spending a lot of time on low priority chemicals 

and that time would not then be available to address higher priority issues. 

Senator THUNE. What safeguards exist to ensure that chemical 

companies don’t cut corners when they bring new chemicals to the 

market? 

Mr. RAWSON. Senator, the bottom line there is that a new chemical can’t get to market unless it has EPA’s approval, unless it 

qualifies for an exemption, in other words, it has already been determined to be part of a category that doesn’t really warrant premanufacture review. But if it doesn’t fall into an exemption, then 

the manufacturer has to submit a pre-manufacture notice and ultimately meet EPA’s data requirements. If it is a chemical that EPA 

feels requires close scrutiny, that falls into one of the many categories of concern that the Agency has identified, the company is 

going to have to provide the data that EPA wants. 

As I said in my testimony and also my written testimony, EPA 

has effectively restricted or prohibited the manufacture of more 

than 3,500 chemicals since TSCA has been enacted. And no company, to my knowledge, has ever taken EPA to court on any 5(e) 

order. In every case, the company has either met EPA’s requirements or withdrawn the PMN. 

Senator THUNE. Mr. Walls, there has been some discussion today 

about the precautionary standard. Is there empirical data that exists to support changing from a risk-based approach along the liens 

of what is used here to more of the approach that is used in the 

European model? 

Mr. WALLS. Senator, we believe that the existing risk-based decisionmaking standard in TSCA is in fact a precautionary approach. 

But if by precautionary standard you mean a hazard-based standard, we believe there is no empirical data for that suggestion. 
25 

Senator THUNE. Mr. Wilson referenced in his testimony this technology gap in the United States. Would you agree that there is a 

lack of innovation that exists in the United States today? 

Mr. WALLS. Senator, I was very interested in Mr. Wilson’s testimony about that. In fact, one-quarter of all patents issued in the 

United States are related to chemistry. That is not evidence of a 

technology gap. We spend $23 billion in research and development 

every year in our industry. That is not evidence of a technology 

gap. That is evidence of an industry that is committed to technological innovation and progress. 

Our companies are also consistently recognized in the Presidential Green Chemistry awards as innovators in chemistry. That 

is a tradition that our industry has established and one we intend 

to continue. 

Senator THUNE. One final question for Ms. Charnley. There was 

a recent National Academy of Science report on bio-monitoring that 

suggested that we cannot assume that the mere presence of a 

chemical will lead to adverse health effects. As a toxicologist, can 

you comment on bio-monitoring and its usefulness and any limitations that it might present? 

Ms. CHARNLEY. Sure. I think that is correct, that bio-monitoring 

data that provide information solely about trace levels of chemicals 

in a blood or urine sample at a single point in time do not allow 

us to draw conclusions about the likelihood of disease. What that 

information can let us do is determine that exposure has occurred, 

to follow trends in exposure over time, to identify unusually exposed individuals, and sometimes to help us clarify the relationship 

between exposure and dose. But they do not provide information 

with regard to the risk or likelihood of ill health, except in some 

rare cases. 

Our analytic abilities are now allowing us to detect smaller and 

smaller amounts of more and more chemicals, but that does not 

mean that we are at greater and greater risk of chemical-related 

disease. 

Senator THUNE. I see, Mr. Chairman, my time is up. So I thank 

you all very much for your responses. 

Senator INHOFE. Thank you, Senator Thune. 

Senator BOXER. Senator BOXER. Thank you, Mr. Chairman. 

Mr. Chairman, I want to start off by asking unanimous consent 

to place in the record an article that appeared in today’s New York 

Times, if I might. 

Senator INHOFE. Without objection, so ordered. 

[The referenced material was not submitted in time for print.] 

Senator BOXER. Unions say EPA bends to political pressure. In 

brief, it says, ‘‘Unions representing thousands of staff scientists at 

the EPA say the Agency is bending to political pressure, ignoring 

sound science and allowing a group of toxic chemicals to be used 

in pesticides.’’ It goes on, they say the chemicals pose serious risks 

for fetuses, pregnant women, young children. These are scientists 

who don’t agree with Ms. Charnley, I don’t think. 

And it goes on to say, ‘‘The complaints from Agency employees 

are the latest to come from within Federal agencies that accuse the 

Bush administration of allowing politics or industry pressure to 
26 

trump science on issues like climate change and stem cell research.’’ ‘‘More and more, the unions are coming together to confront the Agency’s unwillingness to make the appropriate use of 

science to show risk to public health and the environment,’’ said a 

senior scientist, William Herzy. 

And it goes on to say, ‘‘You go to a meeting, where it comes 

down, this is an important chemical, this one we have got to save. 

It is all informal, of course, but it suggest that industry interests 

are governing the decisions of EPA.’’ Anyway, I want to put this 

in the record, because for all the talk about how great the chemical 

companies are, and I am sure some of them are, they are not all 

great. I know we are having trouble just getting the chemical companies to admit that they ought to do more to protect the American 

people in the case of another 9/11. So we have a ways to go. 

Ms. Charnley, your testimony kind of shocked me, because I have 

been, as Senator Jeffords and Senator Lautenberg, working with a 

lot of doctors and scientists on protecting our kids. And you just 

painting this real rosy picture. And I guess what I want to ask you 

is, do you know what the infant mortality rate is in America compared to the rest of the developing world, the developed world, not 

the developing world, but the developed world, the industrialized 

world? Do you know those numbers? 

Ms. CHARNLEY. I don’t. We do pretty well, but we are not the 

best. 

Senator BOXER. No, we are not the best. We are the second 

worst. We are the second worst. So for you to come here and say 

how healthy kids are, read the facts. You come here and present 

yourself as an expert and you don’t even know what the infant morality rate is? I mean, that in itself says to me—I don’t really know, 

you know, who you work for. So maybe you could—I know you do 

some work for EPA, you sit on some of these panels. But in the 

course of your work, have you been hired by chemical companies? 

Ms. CHARNLEY. I work for—— 

Senator BOXER. Industry? 

Ms. CHARNLEY. I work for industry, for Government, I do some 

teaching and I have some non-profits. I have a mix of clients. 

Senator BOXER. Who are the non-profits? 

Ms. CHARNLEY. Environmental Law Institute, one of the mining 

organizations. 

Senator BOXER. Mining—would you get that to me? 

Ms. CHARNLEY. Sure. 

Senator BOXER. Thank you. That will be very helpful. 

Ms. CHARNLEY. And I am not clear about the comment about 

connecting infant mortality rates to chemical exposures. 

Senator BOXER. You are? 

Ms. CHARNLEY. Has that been done? 

Senator BOXER. Well, you just made a statement about our kids’ 

health that was incorrect. And I am correcting you on that. You obviously don’t see the connection, and I was going to ask you this. 

You said it is all about the dose. Would you agree that some chemicals don’t leave the body and they accumulate, so if you look at one 

dose, that is not reflective if in fact the body keeps on building up, 

such as mercury? 
27 

Ms. CHARNLEY. I think that is exactly what I did say, that looking at one dose is not helpful in terms of evaluating risk, but looking at—— 

Senator BOXER. Cumulative? 

Ms. CHARNLEY.—over time can be very helpful. 

Senator BOXER. So would you say that it is, that some chemicals 

are quite harmful if they accumulate in the body? Would you agree 

with that? 

Ms. CHARNLEY. Only if they accumulate to a dose that is toxic. 

And it turns out most of the bioaccumulative chemicals like dioxin 

are now present in our bodies at levels 95 percent less than what 

they used to be. 

Senator BOXER. OK, wait, wait, wait, wait. You would agree with 

me that at a certain point, if chemicals keep on accumulating and 

there is no end to the fact that they keep on—at some point they 

are dangerous, you would agree with that? 

Ms. CHARNLEY. If the toxic dose is reached, they would be. 

Senator BOXER. OK, very good. I am glad we have that agreement, because that is an important point. Because I think we ought 

to follow science on what that level is, and not people who are paid 

by the industry or mining and non-profit companies. 

Mr. Wilson, I want to welcome you. You are a breath of fresh air. 

Is it true you were a fireman before you went into this line of 

work? 

Mr. WILSON. A firefighter/paramedic, yes. 

Senator BOXER. Firefighter/paramedic. So I would like to talk to 

you about that. You know, we heard, and if Senator Clinton were 

here, I think she would talk about this, when the first responders 

came down to 9/11, everything was going to be just fine. And now 

we are seeing all kinds of problems. 

So I want to ask you just a larger question about the impact of 

these chemicals on our workers across the board. 

Mr. WILSON. Well, occupational disease, it is an enormous burden in the United States. We have made estimates in the report 

as to the burden of occupational disease that is directly attributable to chemical exposures in the workplace. And we have provided an analysis of why those numbers actually probably underestimate the true effects. And again, it gets back to the problem 

that there is a data gap in the market. There is an under-appreciation of the effects of chemical exposures that occur in the workplace 

among workers, among health care practitioners, physicians. There 

is a real lack of occupationally trained physicians in the United 

States 

And I worked, during my doctoral dissertation work, I worked 

with automotive mechanics who were using a brake cleaning solvent to clean engines and brakes and what have you. We identified 

a number of them that had developed a debilitating neurological 

disease from their exposure to hexane under uncontrolled conditions. Those individuals went from being productive workers in our 

society to being disabled individuals with the costs of workers comp 

and disability and rehabilitation and what have you. We are seeing 

about 23,000 cases every year in California of deadly chronic disease attributable to chemical exposures in the workplace. And it is 

a serious problem. 
28 

Senator BOXER. Well, I just want to thank you for being here, 

and I agree with you that TSCA needs an overhaul. 

Thank you, Mr. Chairman. 

Senator INHOFE. Thank you, Senator Boxer. We have been joined 

by Senator Warner. Senator Warner, do you have a statement to 

make or a question for this panel? 

Senator WARNER. No, thank you, Mr. Chairman. 

Senator INHOFE. All right. Well, first of all, I again apologize to 

the members for the inconvenience. However, it did seem to work 

out pretty well. Senator Warner, we had an unfortunate death, 

there is a funeral that takes place at 11 o’clock that some members 

of the panel have to attend. Now, the only thing we would be coming back for would be for opening statements at 3 o’clock. I would 

like to ask if that is the desire of the members, to do that, or do 

submit those opening statements for the record. 

Senator BOXER. Mr. Chairman, I would like to, I have about a 

4-minute or 2 minute opening statement, if I could make it. I don’t 

think there is a need to come back. If you could extend until 5 after 

11 o’clock, maybe we can get it done. 

Senator INHOFE. No, we wouldn’t have to extend until 5 after 11 

o’clock, if it is a 4-minute statement, we could recognize you right 

now and that would take us right up to time. If there is no objection on the panel, you are recognized for 4 minutes. 

[Laughter.] 

Senator BOXER. You know, Mr. Chairman, your subtlety is so incredible. 

I want to thank you very much for this opportunity to read my 

statement. And I will summarize it. 

I think what—— 

Senator WARNER. Mr. Chairman, I will be happy to remain, if 

that would convenience the Chair, upon your departure, until the 

colleague from California has completed her remarks. And as you 

vote to leave, may I compliment you and your staff on this renovated hearing room. This is quite elegant. 

[Laughter.] 

Senator INHOFE. I think it is, Senator. I also mentioned that this 

is Cori’s last committee hearing, and we recognized her for the fine 

job that she has done in running this show. 

And it was very generous of you, if you would do that, I would 

appreciate it. 

Senator WARNER. I would be happy to. I know that it is an urgent matter and you have to attend to it, and I will be happy to 

remain until such time as the good colleague from California wishes. 

Senator INHOFE. Aren’t we nice? Thank you. 

[Laughter.] 

Senator BOXER. We are very nice. And thank you, Senator Warner. But I would be devastated if Senator Inhofe misses my statement—— 

[Laughter.] 

Senator BOXER [CONTINUING].—because I know how much impact 

I have on his views on the environment. 

Senator INHOFE. I look forward to reading it. 

[Laughter.] 
29 

Senator BOXER. Thank you. 

OPENING STATEMENT OF HON. BARBARA BOXER, 

U.S. SENATOR FROM THE STATE OF CALIFORNIA 

I also want to thank the staff, Cori, is it, who has given so much 

to this Committee. 

Well, once again we find ourselves conducting the first oversight 

hearing in many years on an important public health statute. We 

waited 4 years for the Superfund hearing we held in June, and my 

understanding is that it has been over a decade since the last comprehensive Toxic Substances Control Act hearing. 

So Mr. Chairman, I am very concerned about this pattern, and 

I believe it has serious consequences for public health. 

TSCA was intended to provide a comprehensive framework to address chemical risks when it was passed 30 years ago. Clearly, we 

know that chemicals widely used and accepted at one time can 

prove to be terribly hazardous and threaten the most vulnerable 

among us because of the issues we have talked about, the fact that 

certain chemicals accumulate in the body. The fact is, after a chemical has been used a long time, we find out more about it. 

Unfortunately, we don’t understand these threats until we have 

adequate testing. TSCA does not ensure that proper testing takes 

place. TSCA was intended to protect the public from hazards associated with the manufacture, import, processing, use and disposal 

of chemicals throughout society. There are over 82,000 chemicals in 

the TSCA inventory, including those used in everyday products, 

like children’s toys or household paint. 

There have been tens of thousands of chemicals added to the 

TSCA inventory since TSCA was enacted. Most Americans would 

probably be surprised to find out that EPA does not routinely assess the human health and environmental impacts of new or existing chemicals. The companies that make these products may not 

have adequate safety data either, and so we are left in the dark, 

to our peril. 

The GAO has issued several reports on this subject and will testify today, and we missed that, I missed that, but the health and 

environmental risks of most chemicals in use today are not known. 

In some cases, we have learned about the potential for serious risks 

posed by everyday chemicals, and yet they are still on the market, 

because we don’t have a strong program in place and there has 

been a failure to protect the public. 

I have an example right here. A set of children’s blocks, sold for 

use by babies 9 to 24 months old. These are products we see every 

day on the shelves. Similar blocks were tested in a lab and were 

found to contain thalates. Animal studies show developmental and 

reproductive effects of this chemical. 

The European Union has regulated thalate exposure in children. 

EPA has not taken similar steps to protect children and TSCA has 

proven a weak tool for addressing these concerns. I don’t want my 

grandchildren and anyone else’s grandchildren or great-grandchildren or children putting this stuff in their mouth. In Europe, 

it is regulated. Not here. 

I am particularly concerned that TSCA fails to include a provision that specifically protects the most vulnerable among us, in-
30 

cluding children. Other environmental statutes, and for that I 

thank this Committee, protect vulnerable populations, including 

the Clean Air Act, the Safe Drinking Water Act, and the Food 

Quality Protection Act. The Safe Drinking Water Act happened to 

be my amendment, but I based it on these other protections. 

I have serious concerns with other weaknesses in TSCA, including very restrictive confidentiality provisions that interfere with 

the public’s right to know, their right to know the risks that we 

face. You know, we in California, we trust our people. We tell them 

what is in a product. You don’t like it. But the fact is, they have 

a right to know, and I will fight with every fiber in my body to 

make sure the public knows what is in these products. 

Let the public vote with their feet. We don’t need a law, Mr. 

Chairman. We told people about the tuna sandwiches they were 

packing for their kids, and we told them that a lot of the imported 

tuna, involved in the catching of that tuna was the killing of dolphins. So we said, we will have a dolphin-safe label. It was simple. 

And guess what? People voted with their feet and they didn’t buy 

that tuna any more, and it had an impact. 

And I think in a free society like this one, freedom of information 

is important. Let the public vote. They ought to know what chemicals are in these products. And it is pretty simple. 

I am proud to be a co-sponsor of the Jeffords utenberg Child, 

Worker and Consumer Safe Chemicals Act. That would be a positive step in increasing information on chemical risks, expands enforcement authorities. And I hope today’s hearing is not the first 

step to close our eyes and not to listen to the scientists at EPA, 

but rather to open up our eyes and our ears and reform TSCA, so 

that it does the kind of good that people expect it to do. 

I thank you very much, Mr. Chairman. 

Senator WARNER. Thank you very much. 

Senator Jeffords, anything further that you know of? 

Senator JEFFORDS. I thank the Senator for her statement, and I 

join her in her statement. 

Senator BOXER. Thank you. 

Senator JEFFORDS. I look forward to working with you on your 

statement. 

Senator BOXER. Thank you very much. 

Senator WARNER. Senator Jeffords, with your concurrence, we 

shall now stand in recess until the call of the Chair. 

Senator JEFFORDS. That is fine with me. 

[Whereupon, at 11:03 a.m., the committee was adjourned.] 

[Additional statements submitted for the record follow.] 

STATEMENT OF HON. JAMES M. JEFFORDS, U.S. SENATOR

FROM THE STATE OF VERMONT

Chairman Inhofe, thank you for holding this important hearing on what I think 

is a fundamental gap in the fabric of our public health protections. 

Recent scientific and medical advances have triggered renewed concerns about the 

adequacy of the U.S. chemical management law. 

Let me highlight five basic facts that should shape how we reform the antiquated 

Toxic Substances Control Act. 

First, without question, chemicals play a vital role in enhancing our quality of life. 

Second, compelling new scientific evidence has uncovered widespread human exposure to industrial chemicals. For example, the U.S. Center for Disease Control 

conducted a comprehensive study revealing exposure to over 100 industrial chemi-
31 

cals in the bodies of ordinary Americans. Another study found over 200 synthetic 

chemicals in the umbilical cord blood of newborn babies. 

Third, most of these chemicals have never undergone any Federal safety review 

or testing. The mere presence of industrial chemicals in small quantities in our bodies does not mean that such levels are dangerous. But after 30 years, shouldn’t the 

EPA have data to tell us more about the potential dangers? 

Fourth, chemical manufacturers generally are not required to conduct basic 

health and safety testing before putting their chemicals into consumer products. A 

study I requested of the General Accountability Office found that the EPA has used 

its authority to require testing for fewer than 200 of the 62,000 chemicals in commerce in 1979, when the EPA program began. 

Finally, the statute fails to give the EPA adequate authority to identify, evaluate 

and respond to dangerous chemicals in a timely manner. 

In 30 years, the EPA has issued regulations to ban or restrict the use of only five 

chemicals. The Agency hasn’t even initiated such a rulemaking since 1989. To make 

matters worse, the EPA’s inaction has occurred in the face of a continuing wave of 

studies that have found links between chemical exposure and various diseases. 

In my opinion, a fundamental overhaul of the Toxic Substances Control Act is 

long overdue. 

A sound chemical policy would promote the use of safe chemicals, and quickly 

identify and manage those few dangerous chemicals that cause cancer; neurological 

or development disabilities; or are otherwise devastating to human health. 

Doctors from the Mount Sinai School of Medicine estimate that the costs of lead 

poisoning, asthma, cancer and developmental disabilities caused by exposure to industrial chemicals is roughly $55 billion annually. For this reason, I was proud to 

draft the Kids Safe Chemicals bill with Senator Lautenberg. 

This bill would protect children by requiring chemical manufacturers to develop 

basic health and safety data on all chemicals used in consumer products. It would 

expand public information so consumers can make informed choices, encourage the 

development of safer alternatives, and give the EPA the tools to take action when 

needed. 

I look forward to today’s hearing, and to working in a bipartisan manner to address this critical public health issue. 

STATEMENT OF JAMES B. GULLIFORD ASSISTANT ADMINISTRATOR, OFFICE OF PREVEN- TION, PESTICIDES AND TOXIC SUBSTANCES, U.S. ENVIRONMENTAL PROTECTION

AGENCY

INTRODUCTION

Mr. Chairman and Members of the Committee, thank you for the invitation to appear before you today. It is my privilege to represent the U.S. Environmental Protection Agency (EPA) during this oversight discussion on the Toxic Substances Control Act (TSCA). 

KEY ACCOMPLISHMENTS

EPA takes very seriously its commitment to implementing TSCA and to protecting both the American public and our environment from the adverse effects of 

chemicals. We are also extremely proud of the many accomplishments we have 

achieved in the past 3 decades and the progress that has been made in protecting 

human health and the environment. 

TSCA provides the Agency with the necessary authority to ensure that new 

chemicals are adequately reviewed, that EPA can require reporting or development 

of information needed to assess existing chemicals, and that those chemicals that 

pose an unreasonable risk can be effectively controlled. Using TSCA as the foundation for our efforts, EPA has, over the decades, developed a wide array of regulatory 

and voluntary approaches and tools to assist us in our goal to protect both human 

health and the environment. Using the strengths of both regulatory and partnership 

approaches we have ensured effective, timely chemical management decisions. We 

have developed sophisticated modeling programs which assist both the Agency and 

industry in developing, reviewing, and manufacturing safer chemicals. We have incorporated broad pollution prevention approaches into both our regulatory work and 

numerous highly successful voluntary programs which have considerably increased 

the speed at which we have been able to achieve environmental results. We have 

worked cooperatively with the regulated community, our stakeholders, our counterparts in other Federal agencies, States and Tribes, and the public on a broad range 

of programs and activities, in order to make informed and transparent chemical 
32 

management decisions. We have also worked closely with the international community on chemical management issues because we recognize that global coordination 

and harmonization is critically important in ensuring a level playing field for all. 

I would like to take a few moments to share with you some of the highlights of the 

progress and achievements of our TSCA-related activities. 

EPA’S REGULATORY ACCOMPLISHMENTS

When TSCA was passed almost 30 years ago, there were 62,000 chemicals on the 

TSCA Chemical Substance Inventory of existing chemicals. Since that time, under 

Section 5 of TSCA (which addresses new chemical review and control), EPA has reviewed more than 45,000 new chemical submissions. EPA has regulated more than 

1,800 of these new chemicals. An additional 1,700 have been withdrawn by industry. 

Approximately 20,000 chemicals have gone into production and have been added to 

the Inventory. The remaining new chemical submissions have either not gone into 

production or were the subject of applications for review as exemptions from 

Premanufacture Notification (e.g., Low Volume Exemptions). Voluntary environmental stewardship programs also play a significant role in our efforts to promote 

the development of safer and greener new chemicals, and innovative programs like 

Sustainable Futures and the Persistent, Bioaccumulative, and Toxic (PBT) Profiler 

are key contributors in this regard, 

Under Section 4 of TSCA, EPA has issued test rules or used Enforceable Consent 

Agreements to require the generation of testing on more than 200 chemicals. EPA 

has also successfully utilized voluntary stewardship approaches to address existing 

chemicals. In 1998, EPA, working cooperatively with the chemical industry and the 

environmental community, under the High Production Volume (HPV) Challenge 

Program, sought commitments from chemical manufacturers to make basic health 

and safety data publicly available on the chemicals produced in the United States 

at over a million pounds a year. While annual production volumes vary substantially over the current Inventory of some 80,000 chemicals, these approximately 

2,800 HPV chemicals account for more than 93 percent of the production volume 

from the chemicals we track on the Inventory. This program has also been coordinated with international testing programs which has resulted in greater participation and has ensured that U.S. manufacturers not bear the entire burden of developing this critical data. Under the Bush administration priority implementation of 

the HPV Challenge Program has continued and, to date, more than 370 chemical 

manufacturers, either individually or as part of an industry consortia, have stepped 

forward to sponsor more than 1,400 chemicals under the HPV Challenge, and over 

800 chemicals have been sponsored under the complementary international effort. 

Data have been submitted for over 97 percent of HPV Challenge chemicals and the 

international effort will continue to contribute information. EPA is reviewing and 

assessing the data submitted on approximately 1700 HPV chemicals to date, to 

identify chemicals that may warrant additional follow-up action or assessment. 

This past Spring, EPA also made good on its 1998 commitment to make the HPV 

data publicly available with its release of the internet-accessible HPV Information 

System. Building on this effort, EPA will co-host a conference this December with 

NEWMOA, the Northeast Waste Management Officials’ Association, which will provide an opportunity for a wide range of stakeholders and interested parties to share 

experiences in using and accessing the HPV data. 

Recognizing the success of the HPV Challenge Program, chemical industry leaders, through the American Chemistry Council, the Soap and Detergent Association, 

and the Synthetic Organic Chemical Manufacturers Association, came together to 

extend the HPV program by announcing in late 2005, their intention to develop 

these health and safety data on an additional 500 HPV chemicals. EPA is very encouraged by this effort and will work closely with the participants as their effort 

proceeds. 

TSCA also provides the Agency with the authority to address unreasonable risks 

through Section 6. To date, the agency has regulated five existing chemicals or 

chemical categories and four new chemicals under Section 6. 

TSCA, through Section 8 requirements, provides the agency with the ability to require recordkeeping and reporting on a wide range of data, including production volume information, health and safety data, and substantial risk information. For example, more than 50,000 health effects, environmental effects, and environmental 

fate studies have been submitted to the Agency. This information helps not only 

EPA, but a number of other Federal Agencies in their efforts to assess chemicals. 

EPA also receives industry submissions under TSCA section 8(e), of ‘‘substantial 

risk’’ information which alerts EPA to critical new test data and which, when appropriate, is referred to other Agencies, industry, and stakeholder groups. 
33 

Section 12 of TSCA ensures that the United State notifies other countries when 

certain chemicals are exported. Section 13 prohibits the import of chemicals that 

would not be in compliance with TSCA. Section 14 puts in place requirements for 

handling confidential business information submitted by companies, and Section 21 

sets forth a process that allows the public to petition the Agency to take action on 

specific chemical issues. 

VOLUNTARY EFFORTS

Recently, a number of voluntary phase-out actions by chemical companies have 

been given regulatory effect through the use of TSCA authority. Several high-profile 

examples include one company’s decision in May, 2000 to voluntarily cease production by 2002 of 88 ‘‘PFOS’’-related perfluorinated chemicals, which were widely used 

in many soil and stain resistant products. EPA, under the Bush administration, 

took prompt regulatory action under Section 5 of TSCA by issuing Significant New 

Use Rules (SNURs) to ensure that new uses of these chemicals will be reviewed by 

the Agency prior to manufacture or re-introduction in the marketplace. EPA subsequently proposed a SNUR for an additional 183 PFOS-related chemicals which 

would subject them to the same requirements. In 2004, following discussions with 

EPA, another U.S. chemical company announced its decision to withdraw 

‘‘PentaBDE’’ and ‘‘OctaBDE,’’ polybrominated diphenyl ether (PBDE) flame 

retardants used in furniture foam and other products, from production by the end 

of 2004. The Agency also followed up this voluntary action with a SNUR that will 

ensure that new uses of these chemicals are reviewed by the Agency prior to introduction into the marketplace. 

During its work on PFOS, the Agency, through Section 8(e) reporting, became 

aware of concerns with a related perfluorinated chemical, ‘‘PFOA,’’ which is used as 

a processing aid in the production of a wide range of stick-resistant consumer products. EPA began the development of a risk assessment and, recognizing we do not 

currently have the data necessary to understand the sources and pathways of 

human exposure to PFOA, launched a formal process with industry and other interested parties to develop needed information utilizing specific testing agreements, including Memoranda of Understanding and TSCA Section 4 Enforceable Consent 

Agreements. EPA is thus working to develop the scientific information needed to 

fully understand how people are being exposed to PFOA and what, if any, concerns 

those exposures may pose. Industry has responded by initiating new studies, including through enforceable as well as voluntary testing efforts. EPA recognized that the 

science was still coming in but the concern was there, so EPA Administrator Stephen Johnson asked eight chemical companies to join the Agency in an environmental stewardship program that has resulted in the industry committing to a 95 

percent reduction in PFOA emissions and product content by no later than 2010, 

and to work toward eliminating PFOA exposure from these sources by no later than 

2015. The effort to gather exposure data will continue in parallel to the stewardship 

program. It is clear from the accomplishments I have just outlined that TSCA provides broad authority to the Agency to adequately control new and existing chemicals, and the ability to address emerging chemical issues as they arise. The Agency’s 

recent efforts on PFOS, PFOA, and PBDEs, provide clear examples demonstrating 

this point. 

NANOTECHNOLOGY

In addition, we believe TSCA is adequate for addressing issues that may arise 

with emerging technologies, such as nanotechnology. The use of nanotechnology has 

enormous potential for a wide array of applications. At this early stage, there are 

few detailed studies on the effects of nanomaterials in the body or the environment. 

However, based on early results, it is clear that it is not yet possible to make broad 

conclusions about which nanomaterials may pose risks. The Agency is moving expeditiously, but thoughtfully, to ensure appropriate oversight of this emerging technology, without impeding its development. TSCA provides the Agency with the regulatory authority needed to help ensure that this emerging technology is used safely. 

We are using our authorities to regulate new chemical substances under Section 5 

of TSCA, which require that all new chemical substances are submitted to the Agency for review prior to manufacture and introduction into commerce. We are also considering developing a stewardship program to increase understanding of both TSCA 

new and existing chemical nanomaterials to complement our on-going new chemical 

efforts, assemble existing data and information from manufacturers and processors 

of these materials, and encourage the development of test data needed to provide 

a firm scientific foundation for future work and regulatory and policy decisions. We 

believe that this approach will ensure that the Agency will be positioned to meet 
34 

our mandate to protect both the public and the environment from any unreasonable 

risks. 

TSCA OVERSIGHT

While I appreciate the opportunity to share with you the highlights of much of 

our work on TSCA over the past three decades, we recognize that no statute is perfect. For this reason, we are most appreciative of the on-going interest of this Committee in TSCA and the work of the United States Government Accountability Office (GAO) in their recent reports on chemical regulation under TSCA and chemical 

regulation in the United States, Canada and the European Union. It is clear that 

there are different statutory approaches to ensure that chemicals are manufactured 

and used safely and that the public and the environment are adequately protected. 

As I stated at the beginning of my testimony, I believe that TSCA provides EPA 

with the statutory tools necessary to achieve these goals. We are committed to using 

sound science to make risk-based decisions, to complementing these actions with 

successful collaborative environmental stewardship programs, and to working with 

Governments around the world on chemical management programs. 

CONCLUSION

The Agency looks forward to continuing to work closely with members of this committee and your staff, and the GAO on their reviews of TSCA as we work together 

to protect human health and the environment. There are many dedicated engineers, 

chemists, biologists, toxicologists, economists, statisticians, attorneys and other civil 

servants who work directly on TSCA issues at EPA. They are among the most scientifically capable and talented staff at EPA and they work extremely hard to effectively implement the myriad of TSCA related activities that I have just shared with 

you. As an organization, they have demonstrated with the outcomes of their work 

the benefits of innovation, collaboration and sound science. I am extremely proud 

of their achievements and to be newly associated with them. Again, I thank you for 

the opportunity to be here today and to provide you with this information. I am 

happy to answer any questions. 

RESPONSES BY JAMES B. GULLIFORD TO ADDITIONAL QUESTIONS

FROM SENATOR INHOFE

Question 1. Mr. Guliford, there has been a lot of criticism of OPPTS’ use of models 

to conduct initial screening of chemicals to determine adverse effects. I find it very 

interesting that these same critics fiercely defend modeling in the Clean Air program or the Clean Water Program, etc. Can you speak to the nature of your models 

and the extent to which they are more likely to overestimate risk than underestimate it? Has there been any third party review of your models? 

Response. Our experience has shown that EPA’s model, is an important and effective tool for screening out potentially hazardous chemicals. My Office (the Office of 

Prevention, Pesticides and Toxic Substances) has worked over the past 25 years to 

verify and improve its modeling tools. EPA has guidance and policy, such as the 

Peer Review Handbook, Information Quality Guidance, as well as draft guidance developed by the EPA Council on Regulatory Environmental Modeling, which addresses the development, validation, and use of models in a planned and systematic process. We have subjected many such tools and models to independent third party peer 

review (e.g., Science Advisory Board). In addition, EPA has worked, and is continuing to work with the European Union and the Organization for Economic Cooperation and Development (OECD) to verify and validate both qualitative (SAR) 

and quantitative (QSAR) Structure-Activity Relationship models (designated together as (Q)SARs).EPA uses data that it receives through new chemical notices, 

test data submissions, and other sources, like the High Production Volume Challenge Program, to support its assessments and to improve the capabilities of its predictive tools, such as (Q)SAR modeling. We also have models that predict human 

and environmental exposures. 

Overall, EPA is confident that the assumptions and inputs used in its models 

result- in risk estimates that are protective of human health and the environment. 

Verification studies and peer reviews support this statement. In addition, the general lack of substantial risk reports under section 8(e) of the Toxic Substances Control Act (TSCA). which are indicative of errors in our new chemical assessments. 

further demonstrates the accuracy and quality of our initial assessment tools. 

Question 2. Mr. Gulliford, we have heard a lot about how companies have not 

‘‘sponsored’’ all 11PV chemicals on the list. Didn’t you just finalize a Section 4 test 
35 

rule covering some of the HPV chemicals that did not have sponsors? Do you plan 

to issue more of those rules? 

Response. EPA issued a test rule for 17 HPV unsponsored chemicals under section 

4 of TSCA on March 16, 2006. We are working on a second HPV test rule scheduled 

to be issued by September 2007 to ensure that this level of test data is available 

for additional HPV chemicals. 

EPA has also used another TSCA reporting mechanism to gather information on 

unsponsored 1-IPV chemicals. On August 16, 2006, EPA published two final 

information- gathering rules under section 8(a) of TSCA. The Preliminary Assessment Information Reporting (PAIR) rule, issued under TSCA section 8(a), requires 

manufacturers of 243 unsponsored HPV chemicals to submit a report on general 

production or importation volume, end use, and exposure-related information that 

is readily obtainable. The Health and Safety Data Reporting rule, issued under 

TSCA section 8(d), requires manufacturers of the same 243 chemicals to submit unpublished health and safety data to EPA. The information required by these rules 

will be used to support additional section 4 rulemakings, as appropriate. 

RESPONSE BY JAMES B. GULLIFORD TO ADDITIONAL AN QUESTIONS

FROM SENATOR JEFFORDS

Question 1. Mr. Gulliford, nanotechnology has tremendous promise in the fields 

of health and environmental cleanup. TSCA has been criticized as being too burdensome to provide the safety assurances to promote this technology in a safe manner. 

What steps are you taking to make sure that EPA can safely and expeditiously 

evaluate these emerging technologies? 

Response. EPA recognizes the promise of nanotechnology and is moving expeditiously, but thoughtfully, to ensure the appropriate review of nanoscale materials, 

while not impeding the development of this technology. The Agency’s current authority to regulate new and existing chemical substances under TSCA extends to 

nanoscale materials, and we have reviewed, and continue to review, new chemical 

nanoscale materials. 

EPA is working in an open and transparent process to further develop a framework to appropriately address nanoscale materials. We are also considering establishing a stewardship program with stakeholder input to increase our understanding 

of both TSCA new and existing chemical nanoscale materials to complement our ongoing efforts. We believe this approach will ensure that the Agency will be positioned to meet our mandate to protect both public health and the environment from 

unreasonable risks. EPA is active in the National Nanotechnology Initiative (NNI) 

through membership in the Nanoscale Science, Engineering and Technology (NSET) 

subcommittee of the Committee on Technology (CT) of the President’s National 

Science and Technology Council (NSTC). Through participation in NSET, several of 

its workgroups, and direct interactions with other Federal Agencies. we have leveraged our research funds as well as increased our ability to assess nanoscale materials. 

RESPONSES BY JAMES B. GULLIFORD TO ADDITIONAL QUESTIONS

FROM SENATOR BOXER

Inadequacy of Voluntary Children’s Chemical Evaluation Program 

Question 1. Assistant Administrator Gulliford. the Voluntary Children’s Chemical 

Evaluation Program is an EPA pilot program to let industry voluntary provide needed safety data on chemicals. 

On June 30, 2006, the EPA’s Children’s Health Protection Advisory Committee 

wrote a letter to EPA saying that the Committee had ‘‘strong concerns with [the 

program’s] structure and implementation.’’ 

The primary goal of the program is to ensure publicly available data on the risks 

to children’s health from toxic chemicals. The Children’s Committee said that the 

‘‘program, as implemented, however, is not on track to fulfilling its stated goal.’’ The 

committee discussed problems with the lack of an adequate peer review process, industry selection of the reviewers and industry production of key documents without 

EPA oversight. 

Is EPA going to implement all of the Children Committee’s recommendations? 

Please provide me with information on EPA’s schedule for implementing these 

recommendations by August 18, 2006, and regular updates thereafter on EPA’s 

progress. 
36 

To the extent that you do not plan to implement any of these recommendations, 

please explain why you do not plan to implement such recommendations. 

Response. Per your request above, the information and response to this question 

was provided to your staff on August 18, 2006. 

LEAD EXPOSURE REDUCTION REGULATIONS

Question 2. Assistant Administrator Gulli ford, Congress amended TSCA in 1992 

by adding Title IV, which required EPA to create a series of regulations that protect 

the public from lead exposures. Lead is a very toxic metal that harms the nervous 

system, especially of children. 

How many of the actions described in Title IV has EPA failed to complete? Please 

list each action, its corresponding statutory provision, any relevant statutory deadline, the status of EPA’s activities responding to Congressional direction, the date 

that EPA expects to complete the required action, and the health effects caused by 

the types of exposures to lead that Congress directed EPA to reduce, including the 

number of children potentially affected by such exposures. 

Response.Through EPA’s coordinated efforts with other Federal Agencies (HUD, 

CDC) there has been substantial progress over the years in reducing harmful exposures to lead in children. Over the period of 1976-2002, the percentage of children, 

ages of 1-5, with elevated blood lead levels has declined steeply from 77 percent to 

1.6 percent with 310,000 children having elevated blood lead levels. 

EPA’s efforts since the inception of the lead program pursuant to the Residential 

Lead-Based Paint Hazard Reduction Act of 1992 (TSCA Title IV) have contributed 

to more recent improvements which show that since the period 1991-1994 the percentage of children between the ages of 1-5 with elevated blood lead levels have declined from 4.4 percent to 1.6 percent or 310,000 children as of the latest CDC reporting period, 1999-2002. EPA is committed to continuing to support the Administration’s goal of eliminating childhood lead poisoning as a major public health concern by the year 2010. 

Health effects associated with exposure to inorganic lead and compounds include, 

but arc not limited to, neurotoxicity, developmental delays, hypertension, impaired 

hearing acuity, impaired hemoglobin synthesis, and male reproductive impairment. 

Importantly, many of lead’s health effects may occur without overt signs of toxicity. 

Lead has particularly significant effects in children, well before the usual tenn of 

chronic exposure can take place. Children under 6 years old have a high risk of exposure because of their more frequent hand-to-mouth behavior (Centers for Disease 

Control and Prevention (CDC), 1991: http:// 

www.cdc.eovincehtleadipublications;booksiplpycicontents.htm). 

EPA’s actions pursuant to Title IV have contributed to mitigating harmful exposure to lead. These include targeted outreach and extensive education activities, as 

well as regulatory actions. 

OUTREACH AND EDUCATION

The Agency’s outreach and education efforts began in 1992 and continue today. 

These efforts greatly contribute to the increase in awareness of the hazards of lead 

generally and the steps the public can take to protect themselves and their families 

from lead-based paint hazards specifically. Actions include: 

• Ensuring that information about known lead-based paint or lead-based paint 

hazards is disclosed to individuals buying or renting pre-1978 housing. (TSCA Section 1018). 

• Operating the National Lead Information Clearinghouse (with additional support from HUD and CDC), which provides the general public and professionals with 

information about lead hazards and their prevention. (TSCA Section 405). 

• Ensuring that information about lead-based paint hazards is provided to owners 

and occupants of pre-1978 housing before renovation activities take place. (TSCA 

Section 406). 

ABATEMENT

EPA has undertaken a range of actions to ensure the abatement of lead hazards 

are conducted safely, including rulemaking: 

• On August 29, 1996, the Agency promulgated regulations for the abatement of 

lead for target housing and for child-occupied facilities, a subset of commercial and 

public buildings. (TSCA 402(a) and (h)). 

• On August 29, 1996 EPA promulgated a model State program that could be 

used by a State to administer and enforce a State lead-based paint program at least 

as protective as the Federal program associated with section 402. Currently 39 
37 

states, the District of Columbia, and three Native American Tribes arc authorized 

by EPA to conduct their own programs. (TSCA Section 404). • On January 2, 2001, the Agency issued regulations that identify lead-based 

paint hazards, lead-contaminated dust, and lead-contaminated soil. (TSCA Section 

403). 

RENOVATION AND REMODELING

EPA is currently in the midst of a rulemaking to mitigate risks posed by lead dust 

in renovation and repair and painting activities. Work to support this effort began 

in 1996; it has been informed by the development of the regulations noted above 

that identify lead-based paint hazards issued in 2001, and most recently a proposal 

was published in 2006. 

• On March 6, 1996, working with HUD, EPA issued a rule containing lead disclosure requirements for sales and leases of older housing. (TSCA Section 1018). • In September 1997, the Agency issued renovation guidelines in residential housing. (TSCA Section 402(c)(l)). • On June 1, 1998, EPA promulgated a regulation that requires each person who 

performs for compensation a renovation of target housing to provide a lead hazard 

information pamphlet to the owner and occupant of such housing prior to commencing the renovation. (TSCA Section 406). • In January 2000, EPA conducted a study of renovation and lead hazards in residential housing. (TSCA Section 402(c)(2)). • In January 2006, EPA issued a proposal to mitigate the risks posed by renovation, repair and painting activities in housing where children reside. The proposal 

includes requirements for work place standards and for the training of renovators, 

for renovations in residential housing with lead-based paint. When finalized, this 

nile, coupled with outreach and education efforts, will target Agency resources toward a comprehensive program that mitigates risks associated with renovation, repair and painting activities. (TSCA Section 402 (c)). 

In carrying out the statutory provisions we have and continue to focus our efforts 

where opportunities for the most meaningful risk reduction exists. 

Question 3. Need for Strong State Programs Assistant Administrator Oulli ford. 

States are stepping up to the plate to protect the public from dangerous chemicals. 

California’s proposition 65 requires consumer information when products contain 

substances known to cause cancer or birth defects. Massachusetts requires facilities 

to undertake pollution prevention plans were practical. At least eight States, including California, have enacted laws restricting the use or production of brominated 

flame retardants, which some studies have shown to have similar threats as DDT 

and PCBs. 

Do you agree that States need to and in fact should protect their citizens, especially children and other vulnerable individuals, from dangerous exposures to toxic 

chemicals? 

Response. Yes, all levels of Government—local, State, and Federal—should work 

together and have the ability to protect their citizens, including children and other 

vulnerable individuals. 

EPA RESOURCES DEVOTED TO IMPLEMENTATING TSCA’S PROTECTIONS

Question 4. Assistant Administrator Gulliford, provide a spread sheet that describes from fiscal year 2001 to 2006 the amount of money (adjusted to 2005 dollars) 

on an annual basis that EPA has obligated and the number of employees, in Federal-Time Equivalents, that EPA has designated to work on actions under TSCA: 

1) Section 5, which authorizes EPA to evaluate submitted information to determine if action is needed to prohibit or limit manufacturing, processing, or the intended use of a chemical; 

2) Section 4, which authorizes EPA to require manufacturers and processors to 

conduct tests to determine if a chemical presents an unreasonable risk of injury to 

health or the environment, or if it is produced in substantial quantities and the potential for release or human exposure is substantial; and 

3) Section 6, which provides EPA with the authority to prohibit or limit the manufacture. import, processing, distribution in commerce, use or disposal of an existing 

chemical. 

Exclude all money and FTEs used to support voluntary initiatives, such as the 

High Production Volume initiative, from these figures. 

Response. EPA is committed to protecting both the American public and the environment in which we live from the adverse effects of chemicals. The Agency has successfully integrated a wide array of regulatory and voluntary approaches to assist 
38 

us in reaching these goals. Using the strengths of both regulatory and partnership 

approaches, we have ensured a comprehensive program that allows us to make 

timely and effective chemical management decisions. These approaches focus on 

generating needed test data, assessing the data, and, when appropriate, taking the 

necessary steps to reduce the health and environmental risks of new chemicals— 

principally a regulatory activity—and chemicals already in commerce—where we 

utilize both regulatory and voluntary activities. 

For example. the Agency developed a comprehensive program for addressing High 

Production Volume (HPV) chemicals that includes: 

• a Challenge program to industry, which started in 1998, to voluntarily make 

basic health and safety data publicly available, 

• regulatory backstops, under Section 4 of TSCA, that will ensure that HPV 

Chemicals are adequately tested; and, under Section 8(a) and (d), that requires reporting that will allow the Agency to make the Section 4 statutory findings on 1- 

IPV chemicals not sponsored in the Challenge program, 

• an information management system, the High Production Volume Information 

System, or HPVIS, that is making the information accessible and useable for EPA, 

other Federal and State Agencies, and the public, 

• and, finally, required reporting of exposure and use information under the IUR 

amendments that will allow risk-based assessments of all HPV chemicals. 

This type of broad, integrated approach to addressing potential chemical risks is 

critical to ensuring that the Agency has the information it needs to effectively assess 

and manage these risks. 

The Agency has also successfully incorporated broad pollution prevention approaches into both our regulatory and voluntary programs, which have considerably 

increased the speed in which we have been able to achieve environmental results. 

This vital integration of regulatory, voluntary, and prevention approaches have also 

helped encourage the introduction of safer and greener new chemicals. 

Question 5. Assistant Administrator Gulliford, provide a spread sheet that describes from fiscal year 2001 to 2006 the amount of money (adjusted to 2005 dollars) 

on an annual basis that EPA has obligated and the number of employees. in Federal-time Equivalents, that EPA has designated to work on voluntary initiatives 

concerning chemical testing and exposures, including but not limited to the High 

Production Volume Initiative and the Voluntary Children’s Chemical Evaluation 

Program. 

Response. EPA is committed to protecting both the American public and the environment in which we live from the adverse effects of chemicals. The Agency has successfully integrated a wide array of regulatory and voluntary approaches to assist 

us in reaching these goals. Using the strengths of both regulatory and partnership 

approaches, we have ensured a comprehensive program that allows us to make 

timely and effective chemical management decisions. These approaches focus on 

generating needed test data, assessing the data, and, when appropriate, taking the 

necessary steps to reduce the health and environmental risks of new chemicals— 

principally a regulatory activity—and chemicals already in commerce—where we 

utilize both regulatory and voluntary activities. 

For example. the Agency developed a comprehensive program for addressing High 

Production Volume (HPV) chemicals that includes: 

• a Challenge program to industry, which started in 1998, to voluntarily make 

basic health and safety data publicly available, 
39 

• regulatory backstops, under Section 4 of TSCA, that will ensure that HPV 

Chemicals are adequately tested; and, under Section 8(a) and (d), that requires reporting that will allow the Agency to make the Section 4 statutory findings on 1- 

IPV chemicals not sponsored in the Challenge program, • an information management system, the High Production Volume Information 

System, or HPVIS, that is making the information accessible and useable for EPA, 

other Federal and State Agencies, and the public, • and, finally, required reporting of exposure and use information under the IUR 

amendments that will allow risk-based assessments of all HPV chemicals. 

This type of broad, integrated approach to addressing potential chemical risks is 

critical to ensuring that the Agency has the information it needs to effectively assess 

and manage these risks. 

The Agency has also successfully incorporated broad pollution prevention approaches into both our regulatory and voluntary programs, which have considerably 

increased the speed in which we have been able to achieve environmental results. 

This vital integration of regulatory, voluntary, and prevention approaches have also 

helped encourage the introduction of safer and greener new chemicals. 

CHART 

Children’s Toys and Dangerous Chemicals 

Question 6. Assistant Administrator Gulliford, provide all requests for information 

that the EPA has sent to the manufacturers of children’s toys sold in the United 

States and chemical manufacturers or processors that produce chemicals used to 

make children’s toys sold in the United States, where the Agency asked for information on the toxicity of chemicals used in the toys, levels of potential exposure to 

those chemicals, and the potential health effects related to children playing with 

such toys. 

Response. EPA takes very seriously its commitment to protect children’s health, 

and TSCA provides authority to protect children from unreasonable risks from 

chemical substances, mixtures, and articles, including toy products. EPA collects information on chemicals manufactured or imported in the United States and listed 

on the TSCA Chemical Substances Inventory. These chemicals may be used in a variety of processes and products. EPA recognized the need for additional reporting 

of processing and use information, including the use of subject substances in consumer products and in products intended for use by children. In 2003, EPA amended the Inventory Update Reporting (1UR) requirements to ensure that the data collected more closely match EPA’s information needs. The inclusion of the children’s 

use category in the IUR will provide the Agency and others with specific reporting 

of the chemicals used in products intended for use by children. The first industry 

reporting of this information must be completed by December 2006. EPA will use 

this data to further its understanding of uses potentially affecting children and 

whether any follow-up actions may he needed. 

To further understand and address hazards and exposures associated with chemicals, including children’s exposures, EPA works with the U.S. Consumer Product 

Safety Commission (CPSC) and other Agencies as appropriate on issues regarding 

consumer products, including those intended for children. 

In addition, in response to a recent TSCA section 21 citizen’s petition regarding 

lead in toy jewelry, EPA published a notice in the Federal Register (71 ER 30921 

(May 31, 2006)) requesting information on the presence of lead in toy jewelry and 

on the health effects. particularly to children, from toy jewelry or similar objects 

containing lead. 

Children’s Toys and Dangerous Chemicals 

Question 7. Assistant Administrator Gulliford, provide a list of the chemicals used 

in toys sold in the 1 United States, including whether each chemical is known or 

suspected of causing cancer, developmental effects or birth defects. 

Response. The Agency takes very seriously its commitment to protect children’s 

health, and TSCA provides authority to protect children from unreasonable risks 

from chemical substances, mixtures, and articles to which children may be exposed. 

including toys. To further enhance our understanding of children’s exposures to 

chemical, EPA has several efforts underway to develop information on products and 

chemicals to which children may be exposed. 

EPA collects information on chemicals manufactured or imported in the United 

States and listed on the TSCA Chemical Substances Inventory. These chemicals 

may be used in a variety of processes and products. In 2003. EPA amended the Inventory Update Reporting requirements to ensure that the data collected more 

closely match EPA’s information needs. Specifically, EPA recognized the need for additional reporting of processing and use information, including the use of subject 
40 

substances in consumer products and in products intended for use by children. The 

inclusion of the children’s use category will provide the Agency and others with specific reporting of the chemicals used in products intended for use by children. The 

first industry reporting of this information must be completed by December 2006. 

EPA will use this data to further its understanding of uses potentially affecting children and whether any follow-up actions may be needed. 

In addition, under EPA’s Voluntary Children’s Chemical Evaluation Program 

(VCCEP), developed after extensive stakeholder dialogue, EPA launched a pilot program to provide data to enable the public to understand the potential health risks 

to children associated with certain chemicals. Under the pilot, EPA asked companies 

which manufacture and/or import 23 chemicals that have been found in human tissues and the environment in various monitoring programs to volunteer to sponsor 

the evaluation under VCCEP. Thirty-five companies and ten consortia responded 

and volunteered to sponsor 20 chemicals. 

To further understand and address hazards and exposures associated with chemicals, including children’s exposures, EPA works with the U.S. Consumer Product 

Safety Commission (CPSC) and other Agencies as appropriate on issues regarding 

consumer products, including those intended for children. 

Cosmetics and Dangerous Chemicals 

Question 8. Assistant Administrator Gulliford, provide all requests for information 

that the EPA has sent to the manufacturers of cosmetics sold in the United States 

and chemical manufacturers or processors that produce chemicals used to make cosmetics sold in the United States, where the Agency asked for information on the 

toxicity of chemicals used in the products, levels of potential exposure to those 

chemicals, and the potential health effects related to applying these cosmetics. 

Response. ‘‘Cosmetics’’ as defined under the Federal Food. Drug and Cosmetics 

Act (12FDCA) arc excluded from the TSCA definition of ‘‘chemical substance and are 

regulated by the Food and Drug Administration. (TSCA section 3(2)(B)(vi)). Therefore, EPA has not issued any information requests relating to cosmetics or substances when intended for use as a component of cosmetics covered by the FFDCA. 

Cosmetics and Dangerous Chemicals 

Question 9. Assistant Administrator Wilford, provide a list of the chemicals used 

in cosmetics sold in the United States, including whether each chemical is known 

or suspected or causing cancer. developmental effects or birth defects. 

Response. Cosmetics arc regulated under the Federal Food. Drug and Cosmetics 

Act by the Food and Drug Administration and are excluded from regulation under 

TSCA. Therefore, EPA does not maintain a list of chemicals used in cosmetics sold 

in the United States. 

RESPONSES BY JAMES B. GULLIFORD TO ADDITIONAL QUESTIONS

FROM SENATOR CLINTON

Question 1. We know that the Food and Drug Administration is working to establish information sharing agreements with its regulatory counterparts in Europe, so 

as to better coordinate information about action taken to protect consumers from 

unsafe drugs or biologics, and. in this age of globalization, I believe we need to see 

similar agreements between the EPA and environmental agencies around the world. 

The European Union is currently implementing a program through which chemical companies are required to submit basic test data on new chemicals—an authority that does not exist under TSCA. Instead, your agency relies on models that estimate the impact of new chemicals based upon what we know about already-existing 

chemicals with similar molecular structures. 

It would seem to make sense—and this is something that chemical companies, according to the GAO Report, support—to set up mechanisms through which the data 

collected by the EU is shared with the EPA. That way. regulatory decisions about 

new chemicals could be based on actual test data, rather than models. 

At the time the GAO report was released in 2005, your agency did not have a 

strategy to obtain such data. Since your testimony noted that the EPA does not require any additional regulatory authority that might be conferred by Congress, do 

I understand correctly that the EPA is currently able to engage in efforts to increase 

information sharing with other Governments? What steps have you taken to develop 

a mechanism through which to share this data? By what date will you establish 

such a system? 

Response. EPA is a leader in international information sharing and is actively engaged in a variety of associated activities. For example, EPA and the European 

Commission are collaborating with other member countries of the Organization for 
41 

Economic Cooperation and Development (OECD) in the development of a Global 

Data Portal. which is intended to ensure that test data available to the United 

States the EU, and other Governments can be shared and accessed. This portal will 

allow searching, viewing and exchange of test data between EPA’s HPV Information 

System (HPVIS) and the test data collected by the EU, as well as similar data from 

other countries. As another example EPA will participate in the development of an 

EU REACH Implementation Project specifically designed to develop guidance on 

grouping chemicals For assessment. Also, EPA worked closely with the Canadian 

Government as they implemented the Canadian Environmental Protection Act 

(CEPA) ‘‘categorization’’ work. That product, when released, will be useful to U.S. 

chemicals assessment work in that it will provide assessments of thousands of 

chemicals, many of which are on the TSCA Inventory. We believe this development 

may provide additional opportunities to collaborate directly on High Production Volume and lower volume chemical issues. 

As conveyed in EPA’s July 31, 2006 response to GAO’s report. Chemical Regulation: Options Exist to Improve EPA’s Ability to Assess Health Risks and Manage 

Its Chemical Review Program (GAO-05-458). the Agency has concerns regarding a 

regulatory approach to collecting the same data that companies are required to submit to the EU. The recommendation referenced in the 2005 GAO report suggests 

a potentially broad-ranging information collection rule under section 8 of TSCA. 

While such a reporting rule may result in the provision of some useful information, 

EPA supports more targeted approaches that are directed at U.S. domestic priorities 

rather than foreign Government mandates. As appropriate, EPA will evaluate and 

implement different approaches to collect information to address information needs, 

taking into account information that will he available through HPVIS, the Global 

Portal, and other mechanisms. 

Question 2. More than 50,000 health effects, environmental effects, and environmental fate studies have been submitted to the EPA, and you note that these studies have helped both your agency and other Federal agencies assess chemicals and 

potential exposure risks. 

How has the data collected through FSCA been used to improve or enhance both 

the CDC’s and EPA’s biomonitoring efforts? For example, if a chemical is noted as 

requiring further study. do you utilize the tools and expertise in your biomonitoring 

programs to develop and carry out tests to assess human exposures? 

Response. EPA receives exposure and effects information through a variety of 

TSCA authorities and programs. Rather than establishing a separate biomonitoring 

effort under TSCA, EPA works through the established CD(’ process (http:// 

www.cdc.gov/exposurereport/) to nominate chemicals for inclusion in the National 

Health and Nutrition Examination Survey (NHANES) biomonitoring efforts where 

EPA believes data obtained from biomonitorine, studies would help us to understand potential population risks. 

For example, EPA recently nominated. and CDC accepted. several chemicals, such 

as certain perfluorinated compounds (PFOS, PFOA, etc.) and certain polybrominated 

diphenyl ethers (PBDEs). among others, to be added to the National Biomonitoring 

Program. The first results will be reported in CDC’s Fourth National Report on 

Human Exposure to Environmental Chemicals, which will be released next year 

(summer 2007). 

STATEMENT OF JOHN B. STEPHENSON, DIRECTOR, NATURAL RESOURCES AND

ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY OFFICE

Mr. Chairman and members of the committee, I am pleased to appear today before the Senate Committee on Environment and Public Works, to discuss our work 

on the Environmental Protection Agency’s (EPA) implementation of the Toxic Substances Control Act (TSCA). Tens of thousands of chemicals are currently in commercial use in the United States and, on average, over 700 new chemicals are introduced into commerce each year. Although these chemicals are an integral component in the production of important goods and services, some may be toxic and may 

adversely affect human health and/or the environment. It was in this context, that 

the Congress passed TSCA in 1976, authorizing EPA to obtain manufacturer information on the risks of chemicals and to control those that EPA determines will pose 

an unreasonable risk. 

TSCA addresses those chemicals manufactured, imported, processed, distributed 

in commerce, used, or disposed of in the United States, but excludes certain substances including pesticides regulated under the Federal Insecticide, Fungicide, and 

Rodenticide Act (FIFRA) and food additives, drugs, and cosmetics regulated under 

the Federal Food, Drug, and Cosmetic Act (FFDCA). TSCA authorizes EPA to re-
42 

1 1AGAO, Chemical Regulation: Options Exist to Improve EPA’s Ability to Assess Health 

Risks and 

view those chemicals already in commerce—what are referred to as existing chemicals—and to assess chemicals before they enter commerce so-called new chemicals. 

EPA lists chemicals currently in commerce in the TSCA inventory. Of the over 

82,000 chemicals currently in the TSCA inventory, about 62,000 were already in 

commerce when EPA began reviewing chemicals in 1979. Since then, approximately 

20,000 new chemicals were added to the inventory and are now in use as existing 

chemicals. 

Prior to the passage of TSCA, chemical substances generally entered the marketplace without review or controls. Without Government intervention, and often with 

little or no knowledge of their potential adverse health and environmental impacts, 

some of these chemicals were produced and used in high volumes. Earlier legislation 

on clean water and air had primarily addressed releases of chemicals into the environment. In contrast, TSCA authorized EPA to control the entire life cycle of chemicals from their production and distribution to their use and disposal—including options for the outright banning of chemical substances to mandating requirements for 

chemical testing or product labeling. Now, chemical companies are required to submit to EPA, 90 days before beginning to manufacture a new chemical, a 

premanufacture notice containing information including the chemical’s identity, categories of uses, estimated production volumes, and any test data possessed by the 

chemical company. 

My testimony today, which is based on our June 2005 report, Chemical Regulation: Options Exist to Improve EPA’s Ability to Assess Health Risks and Manage 

Its Chemical Review Program,1 describes EPA’s efforts to (1) assess existing chemicals used in commerce, (2) control the risks of new chemicals not yet in commerce, 

and (3) publicly disclose information provided by chemical companies under TSCA. 

In summary, EPA does not routinely assess the human health and environmental 

risks of existing chemicals and faces challenges in obtaining the information necessary to do so. TSCA’s authorities for collecting data on existing chemicals do not 

facilitate EPA’s review process because they generally place the costly and time-consuming burden of obtaining data on EPA, rather than requiring chemical companies 

to develop and submit such data to EPA. Consequently, EPA has used its authorities to require testing for fewer than 200 of the 62,000 chemicals in commerce when 

EPA began reviewing chemicals under TSCA in 1979. Recognizing the need for additional information on existing chemicals, in the late 1990s EPA implemented its 

High Production Volume (HPV) Challenge Program, under which chemical companies have begun to voluntarily provide test data on about 2,800 chemicals produced 

or imported in amounts of 1 million pounds or more a year. While the HPV Challenge Program is a laudable effort to develop data on these chemicals, several problems remain, including that the chemical industry has not agreed to provide testing 

for over 200 chemicals originally identified in the HPV Challenge Program and that 

even with the test data provided under the program, EPA would need to demonstrate that the chemicals pose unreasonable risks in order to control their production or use under TSCA. While TSCA does not define what risk is unreasonable, 

according to EPA officials the standard has been difficult to meet. In order to withstand judicial scrutiny, a TSCA rule must be supported by substantial evidence in 

the rulemaking record. In this regard, EPA officials say the act’s legal standards 

are so high that they have generally discouraged EPA from using its authorities to 

ban or restrict the manufacture or use of chemicals. Since Congress enacted TSCA 

in 1976, EPA has issued regulations under the act to ban or limit the production 

of only five existing chemicals or groups of chemicals. 

EPA’s reviews of new chemicals can provide only limited assurance that health 

and environmental risks are identified before the chemicals enter commerce because 

TSCA does not require chemical companies to test new chemicals before notifying 

EPA of their intent to manufacture a chemical. Furthermore, chemical companies 

generally do not voluntarily perform such testing. Because of a general lack of data, 

EPA has developed sophisticated methods to predict the potential exposure and toxicity levels of new chemicals by using scientific models to compare them with chemicals with similar molecular structures for which toxicity information is available. 

However, the use of these models can present weaknesses in the assessment because the models are not always accurate in predicting physical chemical properties 

and the evaluation of general health effects is contingent on the availability of information on chemicals with similar molecular structures. Additionally, chemical company estimates of a chemical’s production volume and anticipated uses provided in 

the premanufacture notices that EPA uses to assess exposure, can change substantially after EPA completes its review and manufacturing begins. However, these es-
43 

timates do not have to be amended by companies unless EPA promulgates a rule 

determining that a use of a chemical constitutes a significant new use, which EPA 

has done for only a small percentage of new chemicals. Despite limitations in the 

information available on new chemicals, EPA’s reviews have resulted in some action 

being taken to reduce the risks of over 3,600 new chemicals submitted for review. 

EPA’s ability to provide the public with information on chemical production and 

risk has also been hindered by strict confidential business information provisions of 

TSCA. TSCA generally prohibits the disclosure of confidential business information 

and, according to EPA officials, about 95 percent of the premanufacture notices for 

new chemicals contain some information that is claimed as confidential. While EPA 

has the authority to evaluate the appropriateness of confidentiality claims, these efforts are time and resource- intensive, and the agency does not have the resources 

to challenge a significant number of claims. State environmental agencies and others have expressed interest in obtaining information claimed as confidential business information for use in various activities, such as developing contingency plans 

to alert emergency response personnel to the presence of highly toxic substances at 

manufacturing facilities. Chemical companies recently have expressed interest in 

working with EPA to identify ways to enable other organizations to use the information given the adoption of appropriate safeguards. 

In our June 2005 report, we recommended that the Congress consider providing 

EPA additional authorities under TSCA to improve its ability to assess chemical 

risks, such as providing the EPA Administrator the authority to require chemical 

companies develop test data when production volumes reach certain levels. We also 

recommended that the EPA Administrator take several actions to improve EPA’s 

management of its chemical program, including revising its regulations to require 

that companies reassert confidentiality claims under TSCA within a certain time period after the information is initially claimed as confidential. EPA did not disagree 

with the report’s findings and is in the process of implementing several of our recommendations. For example, EPA is currently launching a pilot project to review 

claims of confidentiality for data on certain older chemicals. 

EPA HAS LIMITED INFORMATION ON THE HEALTH AND ENVIRONMENTAL RISKS OF EXIST- ING CHEMICALS AND HAS ISSUED FEW REGULATIONS CONTROLLING SUCH CHEMICALS

Because chemical companies are generally not required to develop and submit toxicity information to EPA, when the agency decides to review existing chemicals, it 

generally has only limited information on the risks that the chemicals pose to 

human health and the environment. Furthermore, EPA’s authority under TSCA to 

require industry testing that would provide the information to review the chemicals 

is difficult to use, according to EPA officials. EPA has used its authority to require 

testing for fewer than 200 of the 62,000 chemicals in commerce when EPA began 

reviewing chemicals under TSCA in 1979. Furthermore, EPA has rarely banned, 

limited the production, or restricted the use of existing chemicals. Since 1998, EPA 

has focused its efforts on obtaining information on existing chemicals through voluntary programs, such as the HPV Challenge Program. This program is intended 

to provide basic data on the characteristiCs of about 2,800 chemicals produced in 

excess of 1 million pounds a year. 

EPA Has Limited Toxicity and Exposure Data with Which to 

Review Existing Chemicals 

EPA’s toxicity and exposure data on existing chemicals is often incomplete and 

TSCA’s authority to require testing in support of the agency’s review process is difficult to use. While TSCA authorizes the review of existing chemicals, it generally 

provides no specific requirement, time frame, or methodology for doing so. Chemical 

companies are not required to develop and submit toxicity information to EPA unless the agency promulgates a testing rule, thus placing the burden for obtaining 

data on EPA. In addition, if chemical company testing shows that a chemical is not 

toxic, there is generally no standing requirement that the chemical companies submit this data to EPA. Consequently, when EPA decides to review existing chemicals, 

it generally has only limited information on the risks of injury the chemicals pose 

to human health and the environment. 

EPA officials told us that in cases where chemical companies do not voluntarily 

provide test data and health and safety studies in a complete and timely manner, 

requiring the testing of existing chemicals of concern—those chemicals for which 

some suspicion of harm exists—is the only practical way to ensure that the agency 

obtains the needed information. For example, there are currently over 200 

highproduction-volume chemicals for which chemical companies have not agreed to 

provide the minimal test data that EPA believes are needed to initially assess their 

risks. Furthermore, many additional chemicals are likely to be added to become 
44 

2NGAO, Toxic Substances Control Act: Legislative Changes Could Make the Act More Effective, GAO/RCED-94-103 (Washington, DC: September 26, 1994). 

high production chemicals because the specific chemicals used in commerce are constantly changing, as are their production volumes. Chemical industry representatives told us that TSCA provides EPA with adequate authority to issue rules requiring companies to provide EPA with any test and exposure data possessed by the 

companies, and that EPA could use such authority to obtain company information 

on existing chemicals of concern. EPA could then use that information to determine 

whether additional rules should be issued to require companies to perform additional testing of the chemicals. 

However, EPA officials told us that it is time-consuming, costly, and inefficient 

for the agency to use a two-step process of (1) issuing rules under TSCA (which can 

take months or years to develop) to obtain exposure data or available test data that 

the chemical industry does not voluntarily provide to EPA and then (2) issuing additional rules requiring companies to perform specific tests necessary to ensure the 

safety of the chemicals tested. Officials also said that EPA’s authority under TSCA 

to issue rules requiring chemical companies to conduct tests on existing chemicals 

has been difficult to use because the agency must first make certain findings before 

it can require testing. Specifically, TSCA requires EPA to find that current data is 

insufficient; testing is necessary; and that either (1) the chemical may present an 

unreasonable risk or (2) that the chemical is or will be produced in substantial 

quantities and that there is or may be substantial human or environmental exposure to the chemical. 

Once EPA has made the required findings, the agency can issue a proposed rule 

for public comment, consider the comments it receives, and promulgate a final rule 

ordering chemical testing. EPA officials told us that finalizing rules can take from 

2 to 10 years and require the expenditure of substantial resources. Given the time 

and resources required, the agency has issued rules requiring testing for fewer than 

200 chemicals. Because EPA has used authority to issue rules to require testing so 

sparingly, it has not continued to maintain information on the cost of implementing 

these rules. However, in our October 1994 report on TSCA,2 we noted that EPA officials told us that issuing such a rule can cost hundreds of thousands of dollars. 

Given the difficulties involved in requiring testing, EPA officials do not believe 

that TSCA provides an effective means for testing a large number of existing chemicals. They believe that EPA could review substantially more chemicals in less time 

if they had the authority to require chemical companies to conduct testing and provide test data on chemicals once they reach a substantial production volume, assuming EPA had first determined that these data cannot be obtained without testing. 

We have long held a similar view based on our reviews involving TSCA, and in our 

in June 2005 report, we recommended that the Congress consider giving EPA the 

authority to require chemical manufacturers and processors to develop test data 

based on substantial production volume and the necessity for testing. 

EPA Has Had Difficulty Proving That Chemicals Pose Unreasonable Risks and Has 

Regulated Few Existing Chemicals under TSCA 

Even when EPA has toxicity and exposure information on existing chemicals, the 

agency stated that it has had difficulty demonstrating that harmful chemicals pose 

an unreasonable risk and that they should be banned or have limits placed on their 

production or use. Indeed, EPA has rarely banned, limited the production, or restricted the use of existing chemicals. Since the Congress enacted TSCA in 1976, 

EPA has issued regulations under the act to ban or limit the production or restrict 

the use of only five existing chemicals or chemical classes. For an additional 173 

existing chemicals, EPA has required chemical companies to submit notices of any 

significant new uses of the chemical, providing EPA the opportunity to review the 

risks posed by the new use. 

EPA Implemented a Voluntary Program to Collect More Industry Data on Existing 

Chemicals 

Facing difficulties obtaining information on existing chemicals, EPA took steps to 

address this shortcoming with the implementation of the HPV Challenge Program 

in 1998. According to EPA, the lack of information on existing chemicals and the 

relative difficulty of requiring testing under TSCA on the scale that would be necessary for the thousands of chemicals produced at high volumes, has led EPA, in 

cooperation with chemical companies, environmental groups, and other interested 

parties, to implement a voluntary program to obtain test data on highproductionvolume chemicals from chemical companies. The HPV Challenge Program focuses on 

obtaining chemical company ‘‘sponsors’’ to voluntarily provide data on the approxi-
45 

mately 2,800 chemicals that chemical companies reported in 1990, that they produced at a high volume—generally over 1 million pounds. 

Through this program, sponsors develop a minimum set of data on the chemicals, 

either by gathering available information, using models to predict the chemicals’ 

properties, or conducting testing of the chemicals. EPA plans to use the data collected under the program to prioritize high-production chemicals for further assessment, but it has not yet adopted a methodology for prioritizing the chemicals or for 

determining those that require additional information. In our June 2005 report, we 

recommended that EPA develop and implement such a methodology for using information collected through the HVP Challenge Program to prioritize chemicals for further review and to identify and obtain additional information needed to assess their 

risks. At EPA’s request, a Federal advisory group has proposed a methodology for 

prioritizing the HPV Challenge Program chemicals, and EPA anticipates that the 

agency will implement the proposal during 2006. 

Nonetheless, other problems exist in the HPV Challenge Program. Chemical companies have not volunteered to provide data on all the chemicals currently in the 

HPV Program. In addition, despite the fact that companies may begin raising the 

production volumes of other chemicals, EPA has no mechanism for placing these 

chemicals on the HPV Challenge Program list once they are produced in greater volume. We believe that action to implement our previously mentioned recommendation that the Congress consider giving EPA additional authority to require chemical 

testing could ameliorate such problems. 

EPA LACKS SUFFICIENT DATA TO ENSURE THAT THE POTENTIAL HEALTH AND

ENVIRONMENTAL RISKS OF NEW CHEMICALS ARE IDENTIFIED

EPA’s review of new chemicals provides only limited assurance that health and 

environmental risks are identified because the agency has limited information with 

which to review them. In the absence of chemical test data, EPA largely relies on 

scientific models that do not always accurately determine chemicals’ properties or 

the full extent of their adverse effects. Further, information that companies provide 

in the premanufacture notices that EPA uses to assess potential exposures to new 

chemicals are estimates that can change substantially once manufacturing begins. 

Despite limitations in the information available on new chemicals, EPA’s reviews 

have resulted in some action being taken to reduce the risks of over 3,600 new 

chemicals submitted for review. 

EPA HAS LIMITED INFORMATION ON NEW CHEMICALS AND RELIES ON MODELING TOOLS

TO ASSESS THE HEALTH AND ENVIRONMENTAL RISKS OF NEW CHEMICALS

TSCA generally requires chemical companies to notify EPA of their intent to manufacture or import new chemicals and to provide any available test data. Yet EPA 

estimates that most premanufacture notices do not include test data of any type, 

and only about 15 percent include health or safety test data. Chemical companies 

do not have an incentive to conduct these tests because they may take over a year 

to complete, and some tests may cost hundreds of thousands of dollars. During a 

review of a new chemical, EPA evaluates risks by conducting a chemical analysis, 

searching the scientific literature, reviewing agency files (including files of related 

chemicals that have already been assessed by EPA), analyzing toxicity data on 

structurally similar chemicals, calculating potential releases of and exposures to the 

chemical, and identifying the chemical’s potential uses. On the basis of this review, 

EPA makes a decision to (1) take no action; (2) require controls on the use, manufacture, processing, distribution in commerce, or disposal of the chemical pending development of test data; or (3) ban or otherwise regulate the chemical pending the 

receipt and evaluation of test studies performed by the chemical’s manufacturer. Because EPA generally does not have sufficient data on a chemical’s properties and 

effects when reviewing a new chemical, EPA uses a method known as structure activity relationships analysis to screen and evaluate a chemical’s toxicity. This method, also referred to as the nearest analogue approach, involves using models to compare new chemicals with chemicals with similar molecular structures for which test 

data on health and environmental effects are available. 

EPA officials told us that, while the overall accuracy of the models has not been 

validated for regulatory purposes, they are effective as screening tools that allow 

EPA to focus its attention on the chemicals of greatest concern—chemicals about 

which little is known other than that they are structurally related to known harmful chemicals. By applying approaches that make conservative predictions, EPA believes that it is more likely to identify a false positive (where a chemical is determined to be of concern, but on further analysis is found to be of low concern) than 

a false negative (where a chemical is initially viewed as a low concern though on 
46 

further analysis is actually of higher concern). According to EPA, only about 20 percent of the premanufacture notices received annually go through the Agency’s more 

detailed full-review process after they have been initially screened. That is, according to EPA officials, the majority of new chemicals submitted for review can be 

screened out as not requiring further review because (1) EPA determines on the 

basis of its screening models that a chemical has low potential to harm human 

health or the environment or (2) on the basis of other information, such as the anticipated uses, exposures, and releases of the chemicals, only limited potential risks 

to people and the environment are expected. In addition, using these models, EPA 

identifies for possible regulatory action, those chemicals belonging to certain chemical categories that based on its prior experience in reviewing new chemicals are 

likely to pose potential risks such that testing or controls are needed. In our June 

2005 report, we recommended that the EPA Administrator develop a strategy for 

improving and validating, for regulatory purposes, the models that EPA uses to assess and predict the risks of chemicals and to inform regulatory decisions on the 

production, use, and disposal of the chemicals. 

Estimates of Exposures and Other Information Provided in Premanufacturing Notices Can Change after Manufacturing Begins 

EPA bases its exposure estimates for new chemicals on information contained in 

premanufacture notices. However, the anticipated production volume, uses, exposure 

levels, and release estimates outlined in these notices generally do not have to be 

amended once manufacturing begins. That is, once EPA completes its review and 

production begins, chemical companies are not required under TSCA to limit the 

production of a chemical or its uses to those specified in the premanufacture notice 

or to submit another premanufacture notice if changes occur. However, the potential 

risk of injury to human health or the environment may increase when chemical 

companies increase production levels or expand the uses of a chemical. To address 

this potential, TSCA authorizes EPA to promulgate a rule specifying that a particular use of a chemical would be a significant new use. EPA has infrequently 

issued such rules, which require manufacturers, importers, and processors of the 

chemical for the new use to notify EPA at least 90 days before beginning manufacturing or processing the chemical for that use. 

EPA Reviews of New Chemicals Have Resulted in Some Control Actions 

When EPA’s assessment of a new chemical identifies health and safety problems, 

EPA can issue a proposed rule to prevent chemical companies from manufacturing 

or distributing the chemical in commerce, or to otherwise restrict the chemical’s production or use, if the agency believes the new chemical may present an unreasonable risk before EPA can regulate the chemical under the relevant provisions of 

TSCA. Despite limitations in the information available on new chemicals, EPA’s reviews have resulted in some action being taken to reduce the risks of over 3,600 

new chemicals that chemical companies have submitted for review. These actions 

ranged from chemical companies voluntarily withdrawing their notices of intent to 

manufacture new chemicals, chemical companies entering into consent orders with 

EPA to produce a chemical under specified conditions, and EPA promulgating significant new use rules requiring chemical companies to notify EPA of their intent 

to manufacture or process a chemical for new uses. 

For over 1,700 chemicals, companies withdrew their premanufacture notices, 

sometimes after EPA indicated that the agency planned to initiate the process for 

placing controls on the chemical, such as requiring testing or prohibiting the production or certain uses of the chemical. EPA officials told us that after EPA screens 

a chemical or performs a more detailed analysis of it, chemical companies often drop 

their plans to market a new chemical when the chemical’s niche in the marketplace 

is uncertain and EPA requests that the company develop and submit test data. 

For over 1,300 chemicals, EPA has issued orders requiring chemical companies to 

implement workplace controls or practices during manufacturing (pending the development of information), and/or perform toxicity testing when the chemical’s production volumes reached certain levels. EPA may issue these proposed orders to control 

the production, distribution, use, or disposal of a new chemical when there is insufficient information available to reasonably evaluate the human health or environmental effects of a chemical and when the chemical (1) may present an unreasonable risk to human health or the environment or (2) is or will be produced in substantial quantities and (a) it either enters or may reasonably be anticipated to enter 

the environment in substantial quantities or (b) there is or may be significant or 

substantial human exposure to the substance. While TSCA does not authorize EPA 

to require that chemical companies develop this information, the act does allow EPA 
47 

to control the manufacturing and processing of the chemical until EPA has sufficient 

data to determine if the chemical will pose a risk. 

For over 570 new chemicals submitted for review, EPA required chemical companies to submit premanufacture notices for any significant new uses of the chemical, 

providing EPA the opportunity to review the risks of injury to human health or the 

environment before new uses had begun. 

EPA’S ABILITY TO SHARE DATA COLLECTED UNDER TSCA IS LIMITED

EPA’s ability to make publicly available the information that it collects under 

TSCA is limited. Chemical companies may claim the information they provide to 

EPA under TSCA as confidential business information. While EPA believes that 

some claims of confidential business information may be unwarranted, challenging 

the claims is resource-intensive. 

When companies submit information to EPA through premanufacture notices, 

many claim a large portion of the information as confidential. According to EPA, 

about 95 percent of premanufacture notices contain some information that chemical 

companies claim as confidential. Under EPA regulations, information that is 

claimed as confidential shall generally be treated as such if no statute specifically 

requires disclosure. Exceptions include if the information is required to be released 

by some other Federal law or court order, if the company voluntarily withdraws its 

confidential claim, or if the EPA Office of General Counsel makes a final administrative determination that the information does not meet the regulatory criteria 

substantiating a legal right to the claim. EPA has not performed any recent studies 

of the appropriateness of confidentiality claims, although a 1992 EPA study indicated that problems with inappropriate claims were extensive. That study examined 

the extent to which companies made confidential business information claims, the 

validity of the claims, and the impact of inappropriate claims on the usefulness of 

TSCA data to the public. While EPA may suspect that some chemical companies’ 

confidentiality claims are unwarranted, they have no data on the number of inappropriate claims. 

EPA officials told us that the agency does not have the resources necessary to investigate and, where appropriate, challenge claims that it believes are inappropriate. Consequently, EPA focuses on investigating primarily those claims that it believes may be both inappropriate and among the most potentially important—that 

is, confidentiality claims relating to health and safety studies performed by the 

chemical companies involving chemicals currently in commerce. The EPA official responsible for initiating challenges to confidentiality claims told us that EPA challenges about 14 such claims each year, and that the chemical companies withdraw 

nearly all of the claims when challenged. 

Officials who have various responsibilities for protecting public health and the environment from the dangers posed by chemicals believe that having access to confidential TSCA information would allow them to examine information on chemical 

properties and processes that they currently do not possess and could enable them 

to better control the risks of potentially harmful chemicals. For example, on the 

basis of a study performed by the State of Illinois with the cooperation of chemical 

companies and EPA, Illinois regulators found that toxicity information submitted 

under TSCA was useful in identifying chemical substances that should be included 

in contingency plans in order to alert emergency response and planning personnel 

to the presence of highly toxic substances at facilities. Additionally, the availability 

of this information could assist the states with environmental monitoring and enforcement. For instance, using TSCA data, Illinois regulators identified potential 

violations of State environmental regulations, such as cases where companies had 

submitted information to EPA under TSCA but failed to submit such information 

to the states as required. 

Likewise, the general public may also find information provided under TSCA useful. Individual citizens or community groups may have a specific interest in information on the risks of chemicals that are produced or used in nearby facilities. For example, neighborhood organizations can use such information to engage in dialogue 

with chemical companies about reducing chemical risks, preventing accidents, and 

limiting chemical exposures. 

TSCA’s provisions are in contrast to those of some foreign Governments’ environmental laws, such as Canada, which authorizes its environmental agency to share 

confidential business information with other Governments under agreements or arrangements where the Government undertakes to keep the information confidential. 

Chemical industry representatives told us that the industry also sees benefits in allowing EPA to share information with other countries in order to harmonize chemical assessments among developed countries and improve chemical risk assessment 
48 

methods by allowing cooperation on improving models used to predict chemical toxicity. The chemical industry is concerned, however, that confidential information be 

protected from inappropriate disclosure. These chemical industry representatives 

told us that some countries currently do not have adequate procedures for protecting 

confidential business information. However, they suggested that the policies and 

procedures EPA currently uses to protect confidential information are appropriate. 

Accordingly, they said that the chemical industry would not object to TSCA revisions allowing EPA to share confidential information with foreign countries and organizations, provided that such revisions contain specific reference to safeguards 

that EPA would establish and enforce to ensure that those receiving the information 

have stringent policies and procedures to protect it. 

Our June 2005 report included two recommendations for addressing the problems 

we identified related to the confidential business information provisions of TSCA. 

We recommended that EPA revise its regulations to require companies to reassert 

claims of confidentiality within a certain period after the information is initially 

claimed as confidential. We also recommended that the Congress consider amending 

TSCA to authorize EPA to share with the states and foreign Governments the confidential business information that chemical companies provide to EPA, subject to 

regulations to be established by EPA in consultation with the chemical industry and 

other interested parties that would set forth the procedures to be followed by all recipients of the information in order to protect the information from unauthorized 

disclosures. EPA did not disagree with the report’s findings and is in the process 

of implementing several of our recommendations. For example, EPA is currently 

launching a pilot project to review claims of confidentiality for data on certain older 

chemicals. 

CONCLUDING OBSERVATIONS

Mr. Chairman, EPA’s efforts to encourage companies to voluntarily provide data 

on existing chemicals is commendable. However, the fundamental and historical 

problems the agency has experienced with utilizing its authorities under TSCA continue to limit EPA’s ability to manage its chemical review program and assess 

chemical risks. In this respect, EPA faces considerable difficulties using its authorities to require testing of existing chemicals, which prevents the agency from reviewing substantially more chemicals in less time than it could if it had the authority 

to require chemical companies to provide test data on chemicals once they have 

reached a substantial production volume. Moreover, EPA’s ability to provide the 

public with information on chemical production and risks is hampered by the strict 

confidential business information provisions of TSCA. While protecting such information is a legitimate concern, TSCA currently prohibits EPA from disclosing much 

data for important purposes such as assisting State agencies in carrying out their 

environmental management responsibilities and foreign Governments in harmonizing international chemical assessment approaches—a goal generally shared by 

these Governments and the chemical industry. We believe the actions that we have 

recommended to both the Congress and EPA would go a long way in addressing the 

challenges EPA, faces in exercising its authorities under TSCA. 

Mr. Chairman, this concludes my prepared statement. I would be happy to respond to any questions that you or Members of the Committee may have. 

RESPONSES BY JOHN B. STEPHENSON TO ADDITIONAL QUESTIONS

FROM SENATOR INHOFE

Question 1. In the 2005 report, GAO presents statistical data on the number of 

chemicals for which EPA has required testing or the number of risk reduction actions EPA has taken. Yet you provide no such information for Canada and the European Union. In fact, in the case of the European Union, REACH doesn’t even exist 

yet. Without that data, isn’t it impossible for us to make a direct, law-to-law comparison as to the effectiveness of these programs? 

Response. Our reports in June 2005 (Chemical Regulation: Options Exist to Improve EPA’s Ability to Assess Health Risks and Manage Its Chemical Review Program; GAO-05-458) and in November 2005 (Chemical Regulation: Approaches in the 

United States, Canada, and the European Union; GAO-06-217R) provided descriptive information on differences in the approaches to chemical regulation in the 

United States under TSCA; Canada under the Canadian Environmental Protection 

Act (CEPA); and the European Union (EU) under current legislation and under the 

EU’s proposed legislation known as REACH (Registration, Evaluation and Authorization of Chemicals). Our reports did not compare the relative effectiveness of these 

programs nor did they provide information on the number of chemical tests required 
49 

by or the number of control actions taken under these programs. EPA officials told 

us that simply counting the number of control actions would not provide an adequate comparison of the effectiveness of various national chemical control programs 

because counting control actions would not factor in voluntary programs or companies’ efforts to reduce chemical risks by switching to safer chemicals. Moreover, because the overall statutory and regulatory approaches to chemical regulation differ 

among nations, it would be difficult to make direct comparisons of effectiveness. 

Both Canadian and EU officials told us that concerns over the lack of data on existing chemicals, coupled with difficulties in obtaining data needed to adequately assess the risk of those chemicals, have caused officials in those countries to consider 

revising their basic chemical regulations. 

Question 2. You stated in the report summary that you are unsure if the information collected under HPV will help EPA determine the risks of HPV chemicals. 

What do you suppose the information will be used for, then? Is it really necessary 

to always have a comprehensive data set to determine risk? Isn’t a more targeted, 

tiered and risk-based approach a standard used worldwide? 

Response. The screening level information gathered under the HPV Challenge 

Program will be used to make preliminary judgments about the need for further 

testing or evaluation of high production volume chemicals. However, any further action beyond the voluntary collection of information by EPA requires the use of TSCA 

provisions that EPA has found difficult to use, as noted in our prior reports. 

We have not recommended that EPA develop a comprehensive data set on all 

chemicals, and we have encouraged the agency to target its efforts at those chemicals that pose the greatest risks. EPA, under the HPV Challenge Program, collects 

a data set on program chemicals known as the Screening Information Data Set 

(SIDS) that was developed by the Organization for Economic Cooperation and Development (OECD). The data set includes information on the identity of the chemical; 

its uses, sources and extent of exposure; physical and chemical properties; environmental fate; and certain limited toxicity data for humans and the environment. This 

information allows EPA to make an informed, preliminary judgment about the hazards of HPV chemicals. While the data do not fully measure a chemical’s toxicity, 

it can be used to determine the relative hazards of chemicals and to judge whether 

additional testing or assessment is necessary. Because of the lack of availability of 

basic toxicity information on most high volume chemicals prior to 1998, we believe 

that the HPV Challenge Program is an important first step in obtaining needed 

basic toxicity information. 

However, once the information has been obtained, EPA still faces hurdles in requiring additional testing and/or controlling chemicals that EPA believes will pose 

an unreasonable risk to human health and the environment. As noted in our June 

2005 report, before EPA can issue a rule requiring companies to perform additional 

testing, the agency must demonstrate that a chemical may present an unreasonable 

risk to human health or the environment or will be produced in sufficient quantities 

to present substantial risk to humans or the environment. Consequently, EPA has 

used its authorities to require testing for fewer than 200 of the 62,000 chemicals 

in commerce when EPA began reviewing chemicals under TSCA in 1979. In addition, if EPA believes banning or restricting the manufacture or use of a chemical 

is necessary to protect human health or the environment, it must produce substantial evidence in the rulemaking record and must prove that the chemical will 

present an unreasonable risk to human health and/or the environment. Because the 

act’s legal standards are so high, EPA has issued regulations under the act to ban 

or limit the production of only five existing chemicals or groups of chemicals. 

We have not performed work to determine the approaches or the most appropriate 

types of approaches used by various nations to regulate commercial chemicals. However, on the basis of the results of our work involving TSCA, we have encouraged 

EPA to target its limited resources on those chemicals that pose the greatest risks 

to human health and the environment. 

Question. You mention in the June 2005 Report that EPA has limited ability to 

collect data on existing chemicals. EPA has collected information on about 2,000 existing chemicals so far under the HPV Challenge. Considering Canada has primarily 

used modeling to screen chemicals and REACH isn’t even a law yet, has any other 

country or region in the world collected SIDS base sets anywhere near 2,000 chemicals? 

Response. We have not performed any work to determine the amount of data collected on existing chemicals in Canada or the EU. Nevertheless, according to EPA 

officials, the HPV Challenge Program will collect more information in a short 

amount of time than has been collected to date in Canada and the EU. We have 
50 

not verified the information that EPA claims was submitted under the program nor 

determined the quality of any of the information submitted. 

Our June 2005 Report stated that EPA has limited ability to collect data on existing chemicals in the TSCA inventory (not just the high production volume chemicals). It was the lack of basic toxicity information that led EPA to create the High 

Production Volume (HPV) Challenge Program in order to gather basic toxicity information on those chemicals produced at one million pounds or more. Under the program, EPA collects basic level screening data on HPV chemicals in order to determine the relative hazards and to judge if additional testing is necessary. This allows 

EPA to make a preliminary judgment about the hazards of HPV chemicals as the 

data generally do not fully measure a chemical’s toxicity. In effect, the HPV Challenge program provides the first in a series of steps needed to adequately assess and 

manage chemical risks. While it is an important first step in collecting information 

on existing chemicals, subject matter experts have noted some problems with the 

HPV Challenge Program. First, information submitted by companies thus far has 

not been reviewed to determine its quality or completeness. Second, the majority of 

the data submitted under the program are generated from models, not actual tests. 

Finally, rather than submitting information on individually designated chemicals, 

80 percent of the chemicals are grouped into broad categories for data submission. 

RESPONSES BY JOHN B. STEPHENSON TO ADDITIONAL QUESTIONS

FROM SENATOR BOXER

Question 1. Mr. Stephenson, TSCA’s chemical inventory currently has more than 

82,000 substances. Could you please describe the extent of EPA’s lack of safety data, 

in particular for children, with respect to the chemicals in TSCA’s inventory? 

Response. TSCA does not generally require companies to develop any safety information, absent EPA action, for either new or existing chemicals. While TSCA authorizes EPA to promulgate rules requiring testing of chemicals if EPA has made 

certain findings, TSCA does not require chemical companies to test chemicals prior 

to their use in commerce for toxicity or to gauge exposure levels before they are submitted for EPA’s review, and chemical companies generally do not voluntarily perform such testing. Further, EPA cannot require chemical companies to test existing 

chemicals and provide the resulting test data to the agency unless EPA first determines on the basis of risk or production and exposure information that the chemicals warrant such testing. EPA has used its authority to require testing for fewer 

than 200 of the 62,000 chemicals in commerce when EPA began reviewing chemicals 

under TSCA in 1979. 

In response to several studies that showed that there were relatively few HighProductionVolume (HPV) chemicals for which an internationally agreed upon set of 

hazard screening data was available to the public, EPA, in cooperation with industry, environmental groups, and other interested parties initiated the HPV Challenge 

Program in late 1998. The program was created to ensure that a baseline set of data 

on approximately 2,800 high-production-volume-chemicals would be made available 

to the public. While the HPV Challenge Program looks promising in that, if successful, it will provide EPA and the public with information not previously available on 

the properties of chemicals produced at large volumes in the United States, this program may not provide enough information for EPA to use in making risk assessment decisions. While the data in the HPV Challenge Program may help EPA 

prioritize chemicals of concern for additional review and assessment, the data may 

not present sufficient evidence for EPA to determine whether a reasonable basis exists to conclude that the chemicals present an unreasonable risk of injury to health 

or the environment and that regulatory action is necessary. As our earlier reports 

have indicated, EPA has found it difficult to use the authorities provided under 

TSCA to require companies to develop such data and to restrict the uses or production of chemicals. 

With respect to children’s safety, GAO has not performed the work necessary to 

determine the extent to which EPA lacks data specifically on the adverse effects of 

chemicals on children. However, the limitations noted above would also apply to 

data on risks to children. 

Question 2. Mr. Stephenson, in 1991, the Fifth Circuit Court of Appeals struck 

down EPA’s rule to ban most uses of asbestos. In your view, what is the practical 

impact of that decision on EPA’s ability to use TSCA to enforce mandatory protections on chemicals that present a risk to public health, including to children? 

Response. In 1979, EPA began exploring rulemaking under TSCA to reduce the 

risks posed by exposure to asbestos. Based upon its review of over 100 studies of 

the health risks of asbestos as well as public comments on the proposed rule, EPA 
51 

concluded that asbestos was a potential carcinogen at all levels of exposure. In 1989, 

EPA promulgated a rule under TSCA section 6 prohibiting the future manufacture, 

importation, processing, and distribution of asbestos in almost all products. Some 

manufacturers of asbestos products filed suit against EPA, arguing, in part, that the 

rule was not promulgated on the basis of substantial evidence regarding unreasonable risk. In October 1991, the U.S. Court of Appeals for the Fifth Circuit agreed 

with the chemical companies, concluding that EPA had failed to muster substantial 

evidence to justify its asbestos ban and returning parts of the rule to EPA for reconsideration. 

In its ruling, the court concluded that EPA did not present sufficient evidence to 

justify the ban on asbestos because it did not consider all necessary evidence and 

failed to show that the control action it chose was the least burdensome regulation 

required to adequately protect human health or the environment. As articulated by 

the court, the proper course of action for EPA, after an initial showing of product 

danger, would have been to consider each regulatory option, beginning with the 

least burdensome, and then assess the costs and benefits of each option. The court 

further criticized EPA’s ban of products for which no substitutes were currently 

available stating that, in such cases, EPA ‘‘bears a tough burden’’ to demonstrate, 

as TSCA requires, that a ban is the least burdensome alternative. 

While it is not possible to determine how EPA would have implemented TSCA in 

the absence of the court’s decision, it can be noted that since the decision EPA has 

exercised its authority to ban or limit the production or use of an existing chemical 

only once (for equivalent chromium). In this case, EPA officials said that they had 

started the process for promulgating the rule for equivalent chromium years prior 

to the asbestos decision. EPA officials have suggested that the court’s ruling in the 

asbestos case created a difficult standard for the agency to meet by requiring that, 

before EPA takes regulatory action, it demonstrate that its regulations use the least 

burdensome approach to mitigating unreasonable risks and that its rulemaking is 

supported by substantial evidence. With respect to children, we note that TSCA contains no provisions specifically directing EPA to address the risks that chemicals 

pose to children’s health. 

Question 3. Mr. Stephenson, Government Accountability Office reports going back 

to 1984 have noted that EPA lacks needed toxicity data on chemicals. GAO reports 

from 1994 and 2005 discuss TSCA’s industry-friendly standards as an impediment 

to EPA’s implementing non-voluntary restrictions on the use or production of chemicals. All of these reports also note that EPA lacks adequate resources to fully implement the program. In your opinion, are TSCA’s current provisions the best way for 

Congress to protect individuals, including children, from dangerous exposures to 

toxic chemicals? Or, should we consider modifying the law? 

Response. As we reported in 1994 and 2005, and testified on August 2, 2006, there 

are several actions that the Congress and EPA could take to improve EPA’s ability 

to assess the health and environmental risks of chemicals and to manage its chemical review program. In our reports and testimony, we have recommended that the 

Congress consider (1) providing explicit authority for EPA to enter into enforceable 

consent agreements under which chemical companies are required to conduct testing; (2) giving EPA the authority under section 4 of TSCA to require chemical substance manufacturers and processors to develop test data based on substantial production volume and the necessity for testing; and (3) authorizing EPA to share with 

the states and foreign Governments the confidential business information that 

chemical companies provide to EPA, subject to regulations to be established by EPA 

in consultation with the chemical industry and other interested parties, that would 

set forth the procedures to be followed by all recipients of the information in order 

to protect the information from unauthorized disclosures. 

Moreover, we have identified additional options that the Congress could consider 

to strengthen EPA’s ability under TSCA to assess chemicals and control those found 

to be harmful. In this regard, the Congress could strengthen TSCA by: 

• requiring the systematic testing of existing chemicals; 

• requiring chemical companies to provide additional information on new chemicals; and 

• reducing EPA’s evidentiary burden to take action under TSCA. 

Detailed descriptions of the above options are contained in our prior reports on 

TSCA. While such options exist to make TSCA more effective, their likely benefits 

in protecting human health and the environment would need to be weighed against 

the potential costs of implementing them. 
52 

STATEMENT OF MICHAEL P. WALLS, MANAGING DIRECTOR OF REGULATORY AND

TECHNICAL AFFAIRS, AMERICAN CHEMICAL COUNCIL

I. INTRODUCTION

The American Chemistry Council (ACC) appreciates this opportunity to appear 

before the Committee to discuss the U.S. chemical regulatory control framework, notably the Toxic Substances Control Act (TSCA). In our view, TSCA is a sound statutory and regulatory system. It is a robust vehicle that can effectively address emerging chemical issues, while retaining sufficient flexibility to promote innovation and 

the active involvement of chemical manufacturers in the safe management and use 

of chemicals. 

ACC is the national trade association whose member companies represent more 

than 90 percent of the productive capacity for basic industrial chemicals in the 

United States. ACC member companies are on the cutting-edge of technological innovation and progress, whose products provide significant benefits—benefits that 

save lives, improve health, protect our food supply, and provide jobs throughout the 

Nation. 

ACC member companies are committed to implementing a set of goals and guidelines that go above and beyond Federal regulation on health, safety, security, and 

the environment. Since the Council adopted Responsible Care in 1988, our members 

have reduced emissions by 75 percent and achieved a safety record more than four 

and a half times better than the average for the manufacturing sector overall. ACC 

supports the safe management and use of chemical products. The industry’s regulatory compliance and proactive product stewardship programs allow ACC’s members to manage appropriately the wide range of products made by the business of 

chemistry. 

These comments address the statutory and regulatory safeguards built into the 

current framework for the management of chemicals; some of the voluntary programs that our industry has committed to that build on those safeguards; and why 

it is important to ensure that TSCA remains a flexible, science-based statute that 

can address new scientific challenges and promote technological innovation. 

II. THE OVERALL FRAMEWORK FOR CHEMICALS MANAGEMENT

TSCA is not the only statute that controls risks from chemicals products on the 

market, although it is an important piece of the overall regulatory framework. Other 

statutory requirements focus on chemical uses that may create direct human exposures. For example, information and registration requirements for pesticides are 

covered under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The 

standards for manufacturers of pharmaceuticals, food additives, food packaging, and 

cosmetics are addressed in the Federal Food, Drug and Cosmetic Act (FFDCA). The 

Federal Hazardous Substances Act (FHSA) applies to substances used in consumer 

products. Some 14 different Federal statutes play a role in regulating chemical manufacture, use, distribution and disposal, complemented by State regulatory programs 

in specific areas. 

Unlike the environmental media-driven statutes such as the Clean Air Act, Congress did not set specific metrics or deadlines for actions under TSCA. Instead, Congress has provided the Environmental Protection Agency (EPA) tools to gather information so that risks can be identified and managed, and unreasonable risks eliminated. TSCA was enacted in 1976 in order to prevent ‘‘unreasonable risk of injury 

to health or the environment associated with the manufacture, processing, and distribution in commerce, use, or disposal of chemical substances.’’ Congress properly 

recognized that while a variety of laws existed to ensure the safety of products, EPA 

needed tools to identify potential risks to health and the environment, and to take 

the steps to manage those risks appropriately. 

TSCA was intended to be flexible enough to enable a variety of regulatory responses, and address a variety of needs, including support for regulatory action 

under other statutes. ACC counts this flexibility as one of the key strengths of 

TSCA, particularly as science, technology, and our ability to understand hazards, 

mechanisms of action, and exposures to chemicals have evolved. 

In TSCA, Congress gave EPA a variety of tools to empower the agency to gather 

information, assess that information, and initiate action to address any risk which, 

in the agency’s view, is unreasonable. Key provisions of TSCA authorize EPA to: 

• Establish an inventory of chemical substances which had been on the market 

when TSCA was enacted (the ‘‘existing’’ substances), as well as any substance later 

reviewed and approved by EPA under the ‘‘new substance’’ provisions. (TSCA Scc. 

8(b)) 
53 

• Require the review and approval of any ‘‘new’’ substance prior to manufacturing 

that substance. Companies submitting a pre-manufacture notice (PMN) are required 

to submit any available health or environmental test information that they may already have in their possession. In addition to available test information, the manufacturer must provide information on the chemical identity and structure, and anticipated uses, production volume, by-products, human exposures and disposal practices. EPA has established some 35 PMN policies that provide early guidance to submitters on substances that have particular characteristics. EPA has also developed 

sophisticated and powerful computer modeling—using data gathered over many 

years—that help predict a chemical’s physical and chemical properties, health hazards, exposure potential, and potential environmental effects. If EPA finds the information provided inadequate, EPA has the authority to ask companies for additional 

information under this provision. (TSCA Sec. 5) • Limit ‘‘new’’ uses of existing chemical substances under authority known as a 

‘‘significant new use rule.’’ Using this authority, EPA has successfully restricted well 

over 1,000 substances. These restrictions range from establishing maximum production amounts, dictating allowable uses, instructing on appropriate disposal methods, 

or other measures designed to manage risk. (TSCA Sec. 5) • Require companies to test chemicals to assess potential risks to health or the 

environment. Chemicals that may need test data are brought to EPA’s attention in 

a variety of ways. For example, the Interagency Test Committee (established under 

TSCA and comprised of experts from eight designated Federal agencies and institutes, and a number of other liaison members) regularly evaluates and recommends 

chemicals to test. EPA may also select chemicals on the basis of information provided under any of the information collection sections of the statute. (TSCA Sec. 4) • Regulate existing chemical substances through a variety of mechanisms, including use restrictions, production limitations, warning labels, record keeping, customer 

notifications, or in the most extreme cases, outright bans. Although EPA has successfully pursued a number of actions under this part of TSCA, one case is routinely 

cited (in ACC’s view, incorrectly) for the proposition that ‘‘Section 6 demonstrates 

that TSCA is broken.’’ Contrary to popular perception, the Corrosion Proof Fittings 

opinion does not establish a failing in the statute—it simply established that EPA 

did not follow Congress’ directive. In fact, EPA has successfully regulated other substances under TSCA section 6 including halogenated aromatic compounds, heavy 

metals, and fibers. (TSCA Sec. 6) • Require companies to: (a) keep records on allegations of significant adverse reactions; (b) report information on chemical uses and exposures; (c) provide EPA with 

copies of unpublished health and safety studies; and (d) submit all information in 

their possession that suggests a chemical presents a substantial risk of injury to 

health or the environment. (TSCA Sec. 8) • Require companies to provide notifications of anticipated exports of substances 

subject to test rules under Section 4, and those subject to orders or rules under Sections 5, 6 and 7. The facts around TSCA implementation comprise an impressive 

record: 

• From 1979 though 2003, EPA reviewed approximately 36,000 new chemicals. 

More than 3,000 were subject to some form of regulation as a result of EPA’s reviews. More than 1,200 chemicals are subject to consent orders negotiated by the 

manufacturers with EPA. Such consent orders typically prescribe limitations on use, 

workplace practices, labeling requirements, and release and disposal restrictions. • In more than 500 other cases, EPA permitted the new substance to be produced 

without a consent order, but at the same time promulgated a ‘‘significant new use 

rule’’ (SNUR) that prohibits certain uses of the substance without further prior review by EPA. In approximately 870 cases, the submitter of the pre-manufacture notice agreed to conduct additional testing in response to EPA requests. In some 1,550 

cases, the submitter withdrew the pre-manufacture notice in the face of EPA concerns and likely regulatory requirements. • Since TSCA was enacted, several hundred existing chemicals have been subject 

to testing requirements imposed by EPA under TSCA Section 4. In addition to 

TSCA testing requirements, many companies conduct hazard and environmental 

fate and effects testing on their products, including sometimes very sophisticated 

testing that goes well beyond the testing requirements typically imposed by EPA 

under TSCA. Indeed, the volume of testing that occurs outside of TSCA on a voluntary basis far exceeds testing conducted pursuant to regulatory requirements. 

When toxicity testing of chemicals is conducted under the auspices of a chemical 

specific panel of the American Chemistry Council, a copy of the final study report 

is automatically provided to EPA and several other regulatory Agencies. 

• EPA has developed a Preliminary Assessment Information Rule (PAIR) reporting form that it frequently uses to gather information about the manufacture, use, 
54 

potential for workplace exposure and environmental release of specific chemicals. To 

date, EPA has required manufacturers to complete this form for approximately 475 

chemicals. EPA also has exercised its authority to require the submission of existing 

health and safety data for approximately 1,000 chemicals. 

• Since TSCA was enacted, well over 10,000 ‘‘substantial risk’’ reports have been 

filed with EPA under Section 8(e). 

III. VOLUNTARY PROGRAMS UNDER TSCA

As noted earlier, TSCA provides flexibility to EPA in adapting voluntary programs 

and initiatives that complement the Agency’s regulatory programs. The High Production Volume Challenge (HPV) Program, for example, has provided more hazard 

information, on more chemicals, faster than any other program EPA has ever established. 

HPV Challenge Program 

In 1998, the chemical industry, working with EPA, Environmental Defense and 

others, developed the HPV Program. This unprecedented voluntary initiative had 

the goal of making uniform health and environmental screening information on high 

production volume (HPV) chemicals publicly available by the end of 2005. Through 

the HPV Challenge Program, more than 300 sponsoring manufacturers volunteered 

to provide hazard-screening information on 2,222 HPV chemicals. 

For each of the chemicals sponsored in the program, industry has provided 17 

types of information, including summarized results in four categories: physicalchemical properties, environmental fate, and potential to induce toxicity in aquatic 

organisms and humans. Data to be summarized for human toxicity include studies 

assessing acute toxicity, sub chronic toxicity, genotoxicity, and developmental and 

reproductive toxicity. 

All of the information collected under the HPV Program is important and relevant 

for evaluating a chemical’s potential impact on human health and the environment. 

Additionally, test categories such as genotoxicity and acute, developmental and reproductive toxicity are specifically relevant to protecting children’s health. 

The standard battery of toxicity tests employed by EPA for HPV (and harmonized 

internationally under OECD) includes tests specifically designed to evaluate 

endpoints that provide information on a substance’s potential to pose a health hazard: 

• to development in the womb; 

• to growth and reproduction; 

• from acute poisoning; 

• to cell components that could possibly trigger transformation into cancer later 

in life; 

• to the nervous system (observation for toxicological effects on the nervous system are included as a component of the protocol in every animal toxicity test); 

• to all major organ systems, including the nervous system. 

Thus, the standard battery of TSCA HPV tests is both relevant and important to 

assessing potential health hazards. Results from these tests can and are being used 

to decide what specific, additional toxicity tests are scientifically warranted and necessary to more completely understand specific organ-system hazards, and to more 

fully characterize the dose-response relationship. 

The HPV program, supported by EPA’s HPV Information System (HPVIS), has 

made existing health and environmental effects data sets publicly available on approximately 95 percent (by volume) of the chemicals currently in commerce in the 

United States 

More importantly, EPA is using the HPV data to make decisions on priorities for 

further review. All HPV data—which was always intended for screening purposes 

and not as a complete data set—are being assessed in EPA’s screening mechanism. 

The HPVIS screening process was designed by an EPA stakeholder group (the National Pollution Prevention and Toxic Advisory Committee) after detailed review of 

the needs of a variety of data users. The first step is an automated review, resulting 

in a prioritization of all chemicals for detailed evaluation. ACC supports that process, and looks forward to its timely completion. 

Extended HPV Program 

In March 2005, before the end of the HPV Challenge Program, the chemical industry extended and broadened its current work on HPV chemicals in two ways. 

First, companies are asked to provide health and environmental information for 574 

‘‘new’’ HPV chemicals—chemicals that did not qualify as HPV chemicals at the start 

of the original program, but which now meet the volume threshold according to 
55 

EPA’s 2002 Inventory. Second, the EHPV Program increases the scope of information being collected for all HPV chemicals. In addition to gathering health and environmental information, companies are asked to provide information on use and exposure for both the ‘‘Extended’’ HPV as well as the original ‘‘Challenge Program’’ 

substances. In this way, the EHPV Program will provide EPA and the public with 

an extensive source of chemical safety information on HPV chemicals. 

Together, these voluntary programs are exemplary illustrations of how industry 

has taken responsible action, supported through the flexibility inherent in TSCA. 

All of the important information generated in these voluntary programs will be used 

by EPA to prioritize HPV chemicals for further evaluation, risk characterizations 

and risk assessment. 

Voluntary Children’s Chemical Evaluation Program 

EPA announced its pilot Voluntary Children’s Chemical Evaluation Program 

(VCCEP) in December 2000 to assess certain chemicals for potential risks to children through a series of tiered screens and tests. It was developed as an alternative 

to a TSCA Section 4 test rule. The VCCEP pilot is evaluating both hazard and exposure information on 20 chemicals voluntarily submitted by thirty five companies and 

ten consortia. The key question that the VCCEP aims to answer is whether the potential hazards, exposures, and risks to children have been adequately characterized, and if not, what additional data are necessary. 

Companies participating in VCCEP present a hazard assessment, exposure assessment and risk assessment on their chemical to an independent peer consultation 

panel which then makes a recommendation to EPA about additional data needs 

under the tiered evaluation framework of the program. EPA then makes a data 

needs assessment about the chemical. 

The program is proceeding well and is currently about half completed. Industry 

has lived up to its commitments under the program. ACC believes this pilot program has been very successful at affirming the viability and improved efficiencies 

of tiered approaches to chemical evaluation. It has also improved the practice of 

children’s health exposure assessments and has proved the value of an independent 

peer consultation panel to make data needs recommendations. Although EPA data 

needs decisions have taken a long time, the pilot VCCEP has successfully evaluated 

many important chemicals, including brominated flame retardants, vinylidene chloride, benzene, and acetone. 

The program has shown that a one-size fits all, single tier test battery approach 

to children’s health questions would be wasteful of laboratory animals, costly, inefficient and not nearly as informative as the approach taken under VCCEP. At the 

end of the day, VCCEP is providing a strong, scientific basis for deciding whether 

children’s risks from exposure to chemicals have been adequately characterized and 

additional information is needed to make those characterizations. 

Voluntary programs are conducted under the auspices of TSCA and they play an 

important role in implementing the objectives of TSCA. They permit companies to 

demonstrate their commitment to product safety, and often result in information developed in ways that are faster or less burdensome than would be the case under 

a regulatory mandate. 

III. TSCA MEETS NEW SCIENTIFIC AND TECHNOLOGICAL CHALLENGES

AND PROMOTES INNOVATION

As science evolves, we learn more and more about the relationship between chemistry and health. TSCA’s framework is flexible enough to meet new scientific questions that might be raised about the impact of chemicals on health. Rather than 

amending TSCA to impose new requirements each time thesenew questions arise 

about chemicals, the law and EPA’s implementation of it are flexible enough to address these questions under a science and risk based framework. Concerns about 

endocrine disruption, children’s health, biomonitoring information and nanotechnology can and are being addressed today under TSCA’s information collection, reporting, testing and risk management provisions, (as well as under other existing statutes such as the Food Quality Protection Act of 1996). These are just today’s questions. New scientific questions will continue to arise as science evolves. TSCA provides a dynamic framework for anticipating these issues and developing the scientific information needed to apply its many risk management tools as appropriate. 

TSCA’s framework also promotes the development of innovative chemistries and 

technologies. More new chemical notifications are filed under TSCA than in any 

other major regulatory system, including Europe and Japan. As a result, the business of chemistry in the United States is acknowledged to be a world-leader in solutions that improve science and technology. ACC has no doubt that TSCA has helped 

foster innovation and a significant competitive position for the industry in the world 
56 

economy. Further, TSCA has contributed greatly to the national economy and the 

relative position of the U.S. chemical industry in the global business of chemistry. 

The term ‘‘green chemistry’’ has become a popular term recently, and some have 

argued that TSCA does not do enough to encourage the production of chemicals that 

have little or no toxic effects. ACC members believe in green chemistry—in fact they 

are among the premier practitioners of green chemistry, a fact demonstrated by the 

regular recognition of ACC member companies in programs such as the Presidential 

Green Chemistry Awards. 

It is important to recognize that green chemistry is a framework that aligns technology and innovation with improvements in the health and environmental ‘‘footprint’’ of materials used in our society. Green chemistry is not just about products, 

it is also about the improvements and enhancements in production processes. 

ACC agrees that Government can and should provide encouragement for such collaborations through the sharing of expertise, financial support for research, information exchange and public education. In fact, a variety of Federal agencies (including 

EPA and DOE), companies, professional associations such as the American Chemical Society, and universities are working together to encourage green chemistry 

strategies. 

However, it is inappropriate to blame TSCA for the alleged lack of ‘‘green chemistry’’ approaches. The fact that the statute does not explicitly address green chemistry is not surprising, nor is it important. In ACC’s view, TSCA appropriately does 

not dictate how the process of innovation and collaboration should occur, and in 

what areas. 

IV. CONCLUSION

The American Chemistry Council believes that the Toxic Substances Control Act 

provides a high level of health and environmental protection in the manufacture 

and use of chemical substances. Through TSCA, EPA has significant regulatory authority to take measures necessary to prevent or mitigate unreasonable risks. Moreover, TSCA complements the industry’s product stewardship programs, as do the 

legal and marketplace forces that affect the industry. 

ACC and its member companies appreciate this opportunity to comment on TSCA. 

RESPONSES BY MICHAEL P. WALLS TO ADDITIONAL QUESTIONS

FROM SENATOR INHOFE

Question 1. Mr. Walls, I am acutely aware that TSCA is one of the few laws in 

the United States that directly impacts a company’s ability to sell goods in the marketplace. Can you comment on the effect on innovation and the ability for small 

companies to compete if we impose new regulations and made proprietary business 

information publicly available? 

Response. TSCA promotes innovation in the United States by making it possible 

for EPA to quickly review new chemical products for their potential health or environmental risks, and for companies to provide EPA with essential health, safety and 

environmental information while simultaneously keeping key commercial information confidential. A new regulatory approach that would require proprietary business information to be made routinely available would likely have a severe negative 

effect on innovation in the business of chemistry. 

The issue of proprietary business information and TSCA cannot be taken lightly. 

Congress clearly understood what types of data would be covered by the statute, and 

built in strong protections for confidential business information. TSCA’s new chemical notifications and other reporting requirements compel industry to provide a 

wealth of sensitive data about chemical substances that have commercial value. Examples of such data include: 

• A chemical identity of a new substance that may be a trade secret, or which 

may not yet have received patent protection 

• The volume of the chemical that would be produced, which would signal to competitors the potential market size for the chemical 

• The preferred molecular weight range for a new commercially valuable polymer 

• Impurities, which can signal to those competitors skilled in the art the manufacturing process and or precursor substances 

• Proprietary manufacturing processes 

• The formulations of commercially valuable products and intermediates 

• The commercial uses for which a new or existing substance has value 

Since the business of chemistry involves substantial investment in research and 

development, and results in the development of significant technology, intellectual 
57 

property and valuable trade secrets, it is essential that the provisions to protect confidential information not be weakened. The industry’s $23 billion annual investment 

in research and development relies heavily on the ability to protect that investment. 

Unfortunately, our desire to protect proprietary business information is often misconstrued as a desire to hide safety information. This is simply not the case. ACC 

member companies routinely provide all manner of health, safety and environmental information on their chemicals. This includes the submission of data summaries for more than 11,000 human health studies during the course of the High 

Production Volume Chemical Challenge program. 

Question 2. Mr. Walls, in a recent congressional staff briefing, GAO stated that 

the ACC doesn’t disagree with the GAO 2005 report. Is that true? 

Response. ACC does not agree with GAO’s statement. Approximately a year ago 

GAO asked our reaction to a recommendation that EPA work to share confidential 

information with other Governments. While we indicated that we would certainly 

support a discussion of that recommendation, we did not discuss whether that 

change should be made in a statutory change or some other administrative change. 

Moreover, we noted that this change was not a sufficient reason to open TSCA to 

amendment, but we agreed that there were situations in which an ability to share 

information could be beneficial. 

In its July 2005 report, GAO made seven specific recommendations related to 

TSCA. The GAO recommendations focus on efforts to improve EPA’s ability to assess the health and environmental risks of chemicals and to improve EPA’s management of its chemical review program. Again, GAO did not recommend wholesale 

changes to TSCA nor did it suggest that other regulatory systems, such as the European Union’s REACH system, should be considered. 

Three of the seven recommendations were matters for Congressional consideration. The first recommendation was to provide explicit authority for EPA to enter 

into enforceable consent agreements. ACC believes that the Agency and companies 

should have the ability to negotiate consent agreements —and that EPA already has 

the authority to negotiate those agreements. In its response to GAO, EPA noted 

that an amendment was not necessary for enforceable consent agreements. 

The second recommendation was to provide EPA additional authority to require 

manufacturers to develop test data based on substantial volume and the necessity 

for testing. ACC believes that TSCA already provides EPA with sufficient authority 

to require testing under Section 4 and that additional authority beyond section 4 

is not necessary. 

The third recommendation for Congressional consideration was to authorize EPA 

to share with states and foreign Governments the confidential information that 

chemical companies provide to EPA, subject to regulations to be established by EPA 

in consultation with the chemical industry and other interested parties. ACC recognizes the potential benefit that could be achieved in sharing relevant risk assessment information among the states and foreign Governments. We strongly believe 

that any Government groups accepting CBI from EPA must provide the same level 

of protection to the information as EPA does. In addition, we are concerned about 

whether the U.S. Government would have jurisdiction to police or penalize those 

Governments that allow confidential information to be released. Sharing CBI among 

the states and/or other foreign Government is of interest to ACC, but we do not believe it is sufficient to re-open the statute for change. 

The remaining four recommendations are focused on EPA implementation. They 

include the following: 

1. Development and implementation of a methodology to use HPV information for 

further review: This was always the goal of the HPV program. We understand that 

EPA will be using the screening process developed under the auspices of the National Pollution Prevention and Toxic Advisory Committee. We fully support EPA’s 

efforts to do so. 

2. Issue a Section 8 test rule to require companies to submit to EPA copies of all 

studies and other information submitted to other Governments: Neither ACC nor 

EPA believe that such a test rule is necessary. In its response to the report, EPA 

recommended that ‘‘other more targeted approaches for collecting information which 

are directed at EPA’s domestic priorities, rather than foreign Government mandates, may be more prudent.’’ EPA has also indicated that such information could 

be obtained by voluntary actions and that consideration of Paperwork Reduction Act 

issues would impact Section 8 rulemakings. ACC agrees with these EPA positions. 

3. Develop a strategy for improving and validating models that EPA uses: ACC 

endorses efforts to enhance the usefulness of EPA’s models, and we believe that the 

Agency has already taken action to validate and improve its models. 
58 

4. Require companies to re-assert claims of confidentiality: ACC believes that reassertion of confidentiality claims for all information submitted under TSCA would 

be extraordinarily costly and ineffective. ACC acknowledges that there may be circumstances in which some information originally claimed as confidential in a new 

chemical notification may not need such protection after several years on the market. However, requiring industry to reassert confidentiality claims would impose additional, unnecessary costs on industry. It is also unclear whether EPA would be 

able to accommodate the ‘‘declassification’’ of confidential information in its database. 

I note that TSCA requires EPA to disclose information if it is necessary to protect 

health and the environment against an unreasonable risk of injury, and the statute 

requires manufacturers to share information with EPA about adverse effects from 

chemical exposures. There are established processes for EPA to seek the disclosure 

of CBI, including the possibility that EPA can simply ask the owner of the information for permission to release it. Congress struck an important balance in TSCA between the public right to know and sensitive business information. 

This is also a subject that has been discussed with EPA’s toxic advisory committee 

(National Pollution Prevention and Toxic Advisory Committee), and a pilot project 

is currently looking at what opportunities might exist to address the issue of legitimate but perhaps ‘‘stale’’ CBI claims. 

Question 3. Some claim that TSCA actually serves as a barrier to the introduction 

of newer, safer chemicals. Is this actually the case? 

Response. ACC understands that some—notably Dr. Michael Wilson, in his testimony to the Committee—argue that TSCA’s failure to impose substantial data requirements on all existing chemicals discourages innovations in green chemistry. 

This argument is supported more by speculation than facts. The fact is that more 

new chemical notifications are filed in the United States than in any other country, 

and that those new chemicals are the basis for replacing older existing chemicals. 

As I noted in the response to Question 1, TSCA promotes innovation in chemistry. 

In fact, the proportion of chemicals reported on the TSCA Inventory Update Rule 

that have been through EPA’s new chemicals notification process continues to grow 

every year—reflecting the maturation of markets as new chemicals gain acceptance 

and are seen as effective replacements for other already established chemicals. 

In our view, Government cannot dictate in statute or regulation precisely how the 

process for innovation and collaboration should occur. The fact that TSCA does not 

explicitly address ‘‘green chemistry’’ is not surprising, nor is it important. Green 

chemistry initiatives have existed within EPA and the industry for years, without 

mention of this concept in TSCA. The chemical industry is highly competitive, and 

of necessity is responsive to customer, market and legal demands. TSCA helps the 

industry be responsive by promoting innovation in both the industry’s products and 

the processes in which chemicals are made and used. 

Question 4. There seems to be some confusion about the number of chemicals actually in commerce. From some stakeholders we hear there are 50,000, 60,000, even 

100,000 chemicals in commerce! We are told the number is really closer to 9,000. 

Which is it? 

Response. We hear these inflated numbers all the time. In fact, the larger numbers reflect the number of chemicals that are on the TSCA Inventory, which is a 

historical database of all chemicals that were entered into the system in 1979, plus 

all new chemicals added to the inventory following review by EPA since then. The 

number of chemicals actually in commerce is closer to 9,000. According to EPA figures, over the past four Inventory Update Rules there have been an average of 

about 9,000 non-polymeric chemicals in commerce in quantities of more than 10,000 

lbs/year. As the chemical industry has demonstrated through the High Production 

Volume (HPV) and Extended HPV programs, hazard data has been provided to EPA 

for some 93 percent of the chemicals in commerce by volume—and our industry continues to work with EPA as that data is used to prioritize EPA’s activities. 

RESPONSE BY MICHAEL P. WALLS TO AN ADDITIONAL QUESTION

FROM SENATOR JEFFORDS

Question 1. Mr. Walls, do you believe that the chemical industry would expend 

fewer resources if the EPA evaluated new chemicals on a premarketing basis as opposed to a premanufacturing basis? 

Response. The U.S. system for pre-manufacture review of new chemical substances has spurred innovation, and has helped make the United States a leader 

in bringing new products to market. According to one study conducted for the 
59 

1Toxicity Testing for Assessment of Environmental Agents: Interim Report (2006). 

2 National Pollution Prevention and Toxics Advisory Committee (NPPTAC recommendations 

for a High Production Volume (HPV) Chemical Screening Process (2005) 

OECD, in the United States an average of 425 non-polymeric substances are notified 

in the United States each year, compared to 143 in Europe. Over the years EPA’s 

Office of Pollution Prevention and Toxic Substances (OPPT) has developed programs 

and processes to evaluate new chemical notifications with data and other information, using tools and models that ultimately make the process easier, less expensive, 

and more efficient in terms of market entry and animal welfare. Conversely, the 

EU’s pre-market system with fixed data requirements has led to markedly fewer 

new chemical notifications, and at significantly greater expense. We believe that the 

efficiencies created by the U.S. pre-manufacture system, together with the flexible 

and tiered approaches to data requirements, actually spur innovation and therefore 

generally result in the introduction of newer and greener products faster than in 

other economies. 

RESPONSES BY MICHAEL P. WALLS TO ADDITIONAL QUESTIONS

FROM SENATOR BOXER

INADEQUACY OF TSCA’S TESTING REQUIREMENTS

Question 1. Mr. Walls, just this year, a National Academies of Sciences report concluded, ‘‘TSCA authorized EPA to review existing chemicals, but toxicity and exposure information on them is typically so incomplete that it does not support the review process. EPA can require testing if it determines that a chemical meets a specific set of criteria; however in vitro and whole-animal tests are rarely required. 

Thus, the basis for establishing priorities and requiring testing for industrial chemicals in the United States has not progressed much over the last 20 years.’’ 

Yet, you have testified today that, ‘‘TSCA’s framework is flexible enough to meet 

new scientific questions that might be raised about the impact of chemicals on 

health.’’ 

Do you think that, in fact, a decades old testing system raises some concerns 

about TSCA’s ability to protect public health? 

Response. The National Academy of Sciences report1 referred to in this question 

did not fully consider all programmatic aspects of TSCA. TSCA is not just a testing 

statute. Congress enacted TSCA with an even broader goal of preventing unreasonable risks of injury to health or the environment associated with the manufacture 

and use of chemical. And yes, we believe that as a statutory framework, Congress 

got it right. In fact, Congress was remarkably prescient in providing EPA with a 

strong yet dynamic framework which includes a range of tools that can be adapted 

as science and our understanding of health and environmental risks evolve. This is 

evident in EPA’s ability to develop and disseminate the guidelines for conducting 

both animal and non- animal testing as we better understand mechanisms of action 

and refine our assumptions. And this is evident in TSCA’s ability to manage new 

types of chemistries, including the products of nanotechnologies. 

Unlike media or product specific statutes, TSCA is largely a collection of tools. 

These tools—the authorities to compel action by the regulated community, and the 

power to act when necessary—are entrusted to the Office of Pollution Prevention 

and Toxics. ACC and others have from time to time expressed views on whether or 

not OPPT is appropriately or effectively utilizing those tools. We are therefore impressed that OPPT has formed a Federal Advisory Committee (the National Pollution Prevention and Toxics Advisory Committee) to receive input and advice on its 

implementation of TSCA. Following a period of extensive input and stakeholder consultation, in February 2005 the NPPTAC made detailed recommendations to EPA 

on how it should manage and evaluate the wealth of health, safety and environmental information provided to the Agency under the HPV Challenge Program. As 

you have heard, OPPT is making important strides in this regard, and we believe 

they are to be congratulated. 

Furthermore, as envisioned under the voluntary HPV Challenge program, the collection and public dissemination of hazard data for high production chemicals was 

never meant to be the final step in either company product stewardship or EPA’s 

regulatory oversight. In the NAS report, the efforts of the NPPTAC were not considered; most likely because the NAS committee deliberations were occurring simultaneous with the discussions of the NPPTAC which led to development of NPPTC’s 

‘‘HPV Chemical Screening Process 2’’ The OPPT, using the NPPTAC screening rec-
60 

3National Pollution Prevention and Toxics Advisory Committee (NPPTAC recommendations 

for a High Production Volume (HPV) Chemical Screening Process (2005) 

ommendation, will formally evaluate the data submissions on all of the data submitted for HPV sponsored chemicals; each completed submission contains data on 

18 internationally agreed ‘‘SIDS’’(Screening Information Data Set) endpoints that 

are used as screening-level indicators of potential hazardous effect (toxicity) for humans or the environment, as well as environmental fate. In those cases where an 

evaluation raises specific questions, or suggests a need for further inquiry, there are 

a range of follow-up actions available to OPPT that would support voluntary or regulatory hazard communication and risk management activities. These could include 

gathering additional information on uses and exposures, gathering additional information on potential hazards to support a more in-depth characterization, evaluating 

adequacy of existing risk management programs and practices including Federal 

and State regulatory controls, etc. 

Indeed, the tiered testing and assessment framework of the HPV Challenge illustrates a critical strength of TSCA —a robust and flexible approach that allows EPA 

to focus attention and resources on the substances that pose greatest concern from 

the perspective of potential risk to human health and threats to the environment. 

The standard battery of TSCA HPV tests is both relevant and important to assessing potential health hazards. Results from these tests can and are being used to decide what specific, additional toxicity tests are scientifically warranted, and necessary to more completely understand specific organ-system hazards, and to more 

fully characterize the dose response relationship. The HPV Challenge program has 

shown that a onesize-fits all, single tier test battery would be wasteful of laboratory 

animals, costly, inefficient and not scientifically justifiable. Indeed, support for the 

type of tiered testing and evaluation processes embodied in the HPV and VCCEP 

efforts are endorsed by the National Academy Committee, as stated in their 2006 

report: 

Existing test strategies include test batteries, tiered-testing strategies, tailored 

approaches, and strategies that combine various approaches. The committee finds 

that there are pros and cons of various approaches but leans toward tiered testing 

with the goal of focusing resources on the evaluation of the more sensitive adverse 

effects of exposures of greatest concern rather than full characterization of all adverse effects irrespective of relevance for risk-assessment needs.3

INADEQUACY OF VOLUNTARY CHILDREN’S CHEMICAL EVALUATION PROGRAM

Question 2. Mr. Walls, the American Chemistry Council has some member companies, such as Bayer and BP, which participate on both the EPA’s Children’s Health 

Protection Advisory Committee and the Agency’s Voluntary Children’s Chemical 

Evaluation Program. Other members participate on the Voluntary Children’s Chemical Evaluation Program, such as Monsanto and Proctor and Gamble. 

On June 30, 2006, the EPA’s Children’s Health Protection Advisory Committee 

wrote a letter to the Agency saying that the Committee had ‘‘strong concerns with 

[the program’s] structure and implementation.’’ 

The primary goal of the program is to ensure publicly available data on the risks 

to children’s health from toxic chemicals. The Children’s Committee said that the 

‘‘program, as implemented, however, is not on track to fulfilling its stated goal.’’ The 

Committee discussed problems with the lack of adequate peer review process, industry selection of the reviewers and industry production of key documents without 

EPA oversight. 

While the committee is sounding the alarm about the program’s deficiencies, you 

have testified, ‘‘The program is proceeding well. . . ’’ and that ‘‘ACC believes this 

pilot program has been very successful. . . ’’ 

Do you think that EPA should listen to its Children’s Health Committee and correct the problems highlighted with the program? 

Response. ACC was involved in the multi-stakeholder development of the VCCEP 

pilot program from its inception, as were members of the environmental community 

(including Environmental Defense (ED)), the animal welfare community and EPA. 

EPA launched the program, building on the success of the HPV voluntary challenge 

program. The pilot was designed to test out a tiered, integrated hazard and exposure evaluation of chemicals, as opposed to a hazard only assessment. This approach 

was chosen since children’s exposures to chemicals are probably more determinative 

of their risks than are the inherent hazards of the chemicals, because their exposures can be unique to their behaviors. The goal of the program was to determine 

whether health risks to children from exposures to chemicals could be adequately 

characterized—and to answer that question more effectively than a hazard-only, 
61 

4P.R.D. Williams, J. Patterson and D.W. Briggs, VCCEP Pilot: Progress on Evaluating Children’s Risk and Data Needs. Risk Analysis 26: 781- 799 (2006). 

animal intensive, one-size-fits-all testing program could do. It’s important to recognize the innovative nature of this evaluation approach. ACC believes the program 

has met its objective and has shown that a hazard based ‘‘data gap’’ is not necessarily a ‘‘data need.’’ Devoting resources to ‘‘data gaps,’’ irrespective of whether 

the specific information is actually needed (that is, necessary to characterize children’s risks with an adequate degree of scientific certainty), would be wasteful of 

laboratory animals, costly, inefficient and not scientifically justifiable. 

The pilot has clearly shown that the tiered evaluation process, in which hazard 

information is integrated with exposure information, provides a strong scientific 

basis for deciding whether children’s risks have been adequately characterized, and 

if not, this approach indicates which specific toxicity tests or additional exposure 

data/information is needed to address this critical question. A recent publication in 

the scientific literature illustrates the accomplishments to date of the VCCEP4. Under the pilot, chemical makers are providing extensive dossiers of both hazard 

and exposure information on 20 chemicals identified by EPA. This information is 

rigorously reviewed by an independent panel of scientists (peer consultation) and 

then EPA makes the ultimate decision—based on the peer consultation panel’s report and its own review of all the information—whether additional testing or data 

is needed to characterize risks to children. 

EPA has not yet begun its planned mid-course evaluation of VCCEP, but when 

it does, ACC will participate openly in that process. ACC will identify both the successes of the pilot as well as the areas where improvements could be made to the 

pilot. 

ACC’s suggestions will focus more on how to make the pilot more efficient, not 

how to build a whole new program with wholly different objectives. It’s important 

to be careful at this midpoint stage to maintain the resolve of the volunteer sponsors 

to continue in the program. Industry has lived up to its extensive commitments 

under this program. A two year, multi-stakeholder process created this pilot, and 

it is now only mid way through to completion. Although the VCCEP program has 

not moved as quickly as we might have hoped, the pilot has been an excellent test 

of tiered approaches to chemical evaluation, integrating hazard and exposure information, and of the contributions of independent scientists to EPA’s own assessment 

of data needs. 

STATEMENT OF WILLIAM K. RAWSON, PARTNER AND CHAIR OF THE ENVIRONMENT, LAND AND RESOURCES DEPARTMENT, LATHAM AND WATKINS

Mr. Chairman, distinguished members of the Committee and staff—good morning. 

I would like to begin by thanking the Committee for inviting me to testify today. 

I consider it a privilege to have this opportunity to contribute to the public discourse 

on the Toxic Substances Control Act (TSCA). This is an important subject, and I 

hope that my comments will prove useful to the Committee. 

I am a partner in the law firm of Latham & Watkins and chair its environmental 

practice in Washington, DC. I have been with the firm since 1982, and have practiced in the environmental area, with an emphasis on chemical regulation under 

TSCA and other environmental statutes, since 1987. I have co-authored a TSCA 

Deskbook published by the Environmental Law Institute, and have been involved 

in numerous rulemaking proceedings arising under various sections of TSCA. My 

testimony is based on my experience representing and counseling companies and 

trade associations on issues arising under TSCA and other chemical regulation statutes over the last 19 years. However, the views I will express today are solely my 

own. TSCA section 2 states that it is the policy of the United States that: 

(1) Adequate data should be developed with respect the effect of chemical substances and mixtures on health and the environment; 

(2) Adequate authority should exist to regulate chemical substances and mixtures 

which present an unreasonable risk of injury to health or the environment; and 

(3) Authority over chemical substances and mixtures should be exercised in such 

a manner as not to impede unduly or create unnecessary economic barriers to technological innovation while fulfilling the primary purpose of this chapter to assure 

that such innovation and commerce in such chemical substances and mixtures do 

not present an unreasonable risk of injury to health or the environment. 

The question before the Committee today is whether the provisions of TSCA give 

EPA the authority it needs to achieve these objectives. I believe the answer is ‘‘yes.’’ 
62 

In my judgment, TSCA is a well-crafted statute that has stood the test of time 

quite well. 

SCOPE OF TESTIMONY

My testimony will focus on three sections of the statute: 

• Section 5 pertaining to review, testing and control of new chemicals; • Section 4 pertaining to the testing of existing chemicals; and • Section 6 pertaining to the regulation of existing chemicals. 

I will discuss whether the statutory language in each section is appropriate and 

sufficient to enable EPA to perform its functions under the Act. There are a number 

of issues concerning how EPA has implemented each of these sections of TSCA; for 

the most part, I will not discuss those implementation issues, except insofar as they 

are relevant to assessing the adequacy of the statutory language. I do believe EPA 

could improve its performance under TSCA by addressing some of the implementation issues. 

Also, it is important to understand that TSCA does not stand alone, and actions 

taken by EPA under TSCA represent only a small part of the total chemical management story in the United States. EPA regulates the use, release and disposal of 

chemical substances under many other environmental statutes. Other Federal agencies, including OSHA, FDA and CPSC, also have substantial responsibility for ensuring the safe manufacture and use of chemicals under their respective statutory 

authorities. 

Additionally, chemical manufacturers have adopted voluntary initiatives and 

product stewardship programs to support the safe manufacture and use of their 

products. Many of the industry’s voluntary initiatives have been undertaken in collaboration with EPA and other stakeholders. Again, I will focus primarily on the 

language of the statute, and defer to others to address the voluntary initiatives and 

product stewardship efforts that help meet the objectives of TSCA. 

This testimony assumes the reader is generally familiar with the provisions of 

TSCA and EPA’s principal accomplishments under each section, as much of that information has been provided elsewhere. 

Finally, I would like to express strong appreciation for EPA’s mission. I have 

worked closely with many EPA managers and staff over the years on numerous 

challenging issues, and have great respect for their efforts in support of EPA’s mission. 

SECTION 5: NEW CHEMICALS

The strength of section 5 of TSCA lies in its flexibility. The provisions of section 

5 recognize implicitly that industrial chemicals are not all alike; some are readily 

determined to have low toxicity and to be relatively innocuous, while others present 

significant toxicity concerns that require close scrutiny before commercial manufacture is allowed to commence. Section 5 gives EPA flexibility to vary its assessments 

of new chemicals according to the attributes and expected uses of each substance. 

In this way, EPA is able to ensure that the introduction of new chemicals into commerce does not pose unreasonable risks, without imposing undue economic burdens 

or unnecessary barriers to innovation. 

Many new chemicals qualify for complete or partial exemptions from the 

premanufacture notice (PMN) requirements. Section 5 expressly authorizes exemptions for substances manufactured or processed only in small quantities solely for 

R&D, for substances manufactured or processed for test marketing purposes, and 

for non-isolated intermediates. Section 5(h)(4) also authorizes EPA to promulgate 

rules exempting other categories of new chemical substances from all or part of the 

PMN requirements, if the Agency has determined that the substances ‘‘will not 

present an unreasonable risk of injury to health or the environment.’’ 

EPA has used this authority to create additional partial exemptions for polymers, 

chemicals that will be produced only in low volumes, and chemicals for which the 

manufacturer is able to demonstrate low release and exposure. EPA also has created 

exemptions for certain categories of chemicals that are produced but have no separate commercial purpose, such as impurities. Thus, section 5 gives EPA authority 

to streamline the new chemical review process for categories of chemicals that can 

be determined upfront not to pose unreasonable risks to health or the environment. 

In this way, section 5 promotes the efficient use of EPA resources, and also avoids 

imposing unnecessary burdens on industry. 

Some new chemical substances do not qualify for an exemption, but can readily 

be determined to pose little or no risk to health or the environment based on information provided with the PMN, use of EPA models, and comparison to other previously approved substances (using a methodology known as structure activity rela-
63 

1GAO, Chemical Regulation: Options Exist to Improve EPA’s Ability to Assess Health Risks 

and Manage Its Chemical Review Program, at 12 (June 2005) [hereinafter GAO Report]. 267 Fed. Reg. 11,014, 11,020 (Mar. 11, 2002) (Perfluoroalkyl Sulfonates. Proposed Significant 

New Use Rule) (’’EPA determined that the proposed SNUR should be promulgated as final for 

the 13 chemicals, employed principally in coatings for textiles, carpet, apparel, leather, and 

paper, on which no comments were received and which 3M, the sole manufacturer, confirmed 

were discontinued from manufacture before Dec. 31, 2000.’’). In the original proposed SNUR, 

these chemicals were referred to collectively as perfluorooctylsulfonates, or PFOS, but commenters noted that this generic usage of the term PFOS was inconsistent with the use by the 

manufacturer of PFOS to refer only to chemicals with an eight-carbon, or C8, chain length. 3Battelle, Overview: Office of Pollution Prevention and Toxics Programs, at 18-19 (Dec. 24, 

2003) [hereinafter Battelle Report]; see also 67 Fed. Reg. 72,854, 72,859 (Dec. 9, 2002) 

(Perfluoroalkyl Sulfonates; Significant New Use Rule). 

tionship, or SAR). In fact, according to EPA officials, the majority of new chemicals 

submitted for review can be screened out as not requiring further review based on 

screening models that show low potential for toxicity, or based on other information 

(anticipated uses, potential for releases and exposures) demonstrating low potential 

risks.1 Again, section 5 allows EPA the flexibility to make these judgments, and to 

adjust the new chemical review process accordingly. 

Many new chemical substances, however, do require close scrutiny before they 

enter commerce. With regard to these substances, some stakeholders have expressed 

a concern that there is no minimum base set of tests that must be submitted with 

the PMN, to facilitate EPA review. However, section 5 effectively gives EPA the authority to require the PMN submitter to conduct the testing that EPA deems necessary in each case to support a determination whether the manufacture or use of 

the PMN substance will pose unreasonable risks. Thus, additional authority is not 

necessary. 

Specifically, section 5(e) gives EPA authority to prohibit or limit the manufacture 

and use of any new chemical substance where: (1) existing information is insufficient to permit a ‘‘reasoned evaluation’’ of the substance’s health and environmental 

effects; and (2) either the substance may present an unreasonable risk of injury to 

health or the environment, or the substance will be produced in substantial quantities and there will or may be substantial human or environmental exposure. EPA 

has used its authority under section 5(e) to require testing of numerous PMN substances. EPA also has developed a guidance document that identifies numerous 

chemical categories of concern, and identifies the type of test data that typically will 

be required for a PMN substance in each category. 

In some cases, the PMN submitter has agreed to conduct the testing during the 

PMN review process (by also agreeing to suspend the statutory PMN review period 

during the conduct of the testing). In other cases, the testing requirements have 

been incorporated into a consent order issued under section 5(e). In either event, 

EPA has received the information that it has deemed necessary to assess the potential risks associated with the new chemical. 

Additionally, EPA has authority under section 5(a) of TSCA to promulgate a significant new use rule (SNUR) for a PMN substance, and thereby to require a company to submit a significant new use notice (SNUN) to EPA before engaging in uses 

identified in the SNUR. SNUNs operate much like PMNs; they enable EPA to 

evaluate new uses of a chemical substance before they are undertaken and decide 

whether such uses should be subject to special regulations. EPA has used its SNUR 

authority to codify the restrictions in section 5(e) orders so they apply to subsequent 

manufacturers of the chemical, and also to control the uses of existing, TSCA inventory-listed chemicals that raise concern. 

EPA’s relatively recent use of SNURs in connection with the voluntary phase-out 

of perfluoroalkyl sulfunate (PFAS) substances is a good example of how EPA can 

use a SNUR to address hazards associated with an Inventory-listed substance. In 

May 2000, the sole U.S. manufacturer of perfluorooctanyl sulfunate (PFOS) announced it would voluntarily withdraw production. The phase-out was completed in 

2002. Following this, the EPA issued a SNUR in March 2002 limiting any new manufacturing or importing of 13 PFAS chemicals that were being produced by 3M.2 In 

December 2002, the EPA issued a second SNUR adding 75 additional chemicals, but 

excluding ‘‘low volume, controlled exposure uses in: semiconductor manufacture, 

aviation hydraulics, and photography.’’3 Thus, through close cooperation with industry and use of its authority under section 5(a)(2), the EPA was able to extend the 

voluntary phase-out by the sole manufacturer to all prospective producers and importers of the subject compounds. 

Also, under section 5(f) of TSCA, if EPA determines a new chemical substance 

‘‘presents or will present an unreasonable risk of injury to health or the environment before a rule promulgated under section 2605 [section 6] of this title can pro-
64 

4Battelle Report, supra n.3, at 11. 

5GAO Report, supra n.1, at 26. 

tect against such risk,’’ the Agency may issue a proposed rule under TSCA section 

6(a) that is effective upon its publication in the Federal Register, or alternatively 

may issue an order or may apply for an injunction in Federal court to prohibit the 

manufacture, processing, or distribution in commerce of the substance. 

As of September 30, 2002, EPA had taken the following actions: 

• Issued 1243 section 5(e) orders (500 with SNURs, and 743 without); 

• Promulgated an additional 437 non-section 5(e) SNURs; and 

• Taken four actions under section 5(f). 

Further, 1552 PMNs had been withdrawn in the face of impending EPA action. 

Thus, it is clear that EPA has exercised its authority under section 5. to give careful 

scrutiny to new chemical substances where appropriate. EPA in fact has imposed 

substantial controls or effectively prohibited the manufacture of more than 3200 

chemical substances.4

It is noteworthy that under section 5(e)(1)(C), a PMN submitter may file objections with EPA to a proposed 5(e) order, and EPA is then forced to go to court to 

obtain an injunction to prohibit or limit the manufacture or use of the PMN substance (unless EPA determines that the objections have merit and alters or withdraws the proposed order). To my knowledge, no PMN submitter has ever forced 

EPA to go to court to obtain such an injunction. In other words, no PMN submitter 

has ever challenged a 5(e) order judicially; the PMN submitter has either complied 

or withdrawn the PMN. This means in every case EPA’s data requirements and control requirements have been met, or the PMN has been withdrawn. 

PMN submitters have not always been pleased with EPA’s proposed testing requirements or control requirements. Some PMNs have been withdrawn because the 

PMN submitter did not agree with the proposed testing or control requirements, and 

the costs associated with those requirements rendered commercialization impractical. But there has never been a legal challenge. Thus, while there may be issues 

around the edges pertaining to how EPA has implemented section 5 of TSCA, there 

does not appear to be any basis for arguing that EPA lacks authority to assess or 

regulate new chemical substances. To the contrary, the provisions of section 5 appear well-designed to give EPA the necessary flexibility and discretion to give each 

PMN substance the level of scrutiny it merits, and to impose such restrictions on 

manufacture and use as are necessary to prevent unreasonable risks to health and 

the environment. 

SECTION 4: TESTING OF EXISTING CHEMICALS

TSCA section 4 provides EPA with authority to impose health and environmental 

effects testing requirements on chemical manufacturers and processors. EPA has 

authority to require testing of existing chemicals under two circumstances: when a 

chemical ‘‘may present an unreasonable risk’’ (the 4(a)(1)(A) or ‘‘A’’ finding), or when 

a cheMical ‘‘is or will be produced in substantial quantities’’ and either ‘‘enters or 

may reasonably be anticipated to enter the environment in substantial quantities,’’ 

or ‘‘there is or may be significant or substantial human exposure’’ (the 4(a)(1)(B) or 

‘‘B’’ finding). In each case, EPA also must show that (i) there is insufficient data 

or experience to determine whether manufacture and use pose unreasonable risks 

to health or the environment, and (ii) testing is necessary to develop this data. Over 

the years, EPA has made significant progress in developing testing programs for existing chemicals and has issued detailed regulations governing development of test 

rules, negotiation of enforceable testing consent agreements, and compliance with 

testing requirements under test rules and consent orders. 

EPA has obtained test data for more than 200 substances under TSCA section 4 

test rules or enforceable consent agreements. Many more chemicals have been 

screened for testing and determined by EPA or the Interagency Testing Committee 

(ITC) to be low priority for testing or not to require further testing, and testing of 

many more substances has occurred on a voluntary basis without the need for a test 

rule. The High Production Volume Challenge Program, which involved more than 

2100 substances, is certainly a noteworthy example of a voluntary testing initiative, 

but many individual substances also have been the subject of voluntary testing that 

has made action under section 4 of TSCA unnecessary. 

There has been some suggestion that the findings required by section 4 of TSCA 

are overly burdensome on EPA, and render section 4 an ineffective vehicle for obtaining test data.5 I find these arguments unpersuasive. The burden of proof that 
65 

6Chem. Mfrs. Ass’n v. EPA, 859 F.2d 977 (DC Cir. 1988). 

7Id at 984-88. 

8Chem. Mfrs. Ass’n v. EPA, 899 F.2d 344 (5th Cir. 1990). 

9EPA, TSCA Section 4(a)(1)(B) Final Statement of Policy: Criteria for Evaluating Substantial 

Production, Substantial Release, and Substantial or Significant Human Exposure, 58 Fed. Reg. 

28,736 (May 14, 1993) [hereinafter, ‘‘B Policy’’]. 10GAO Report, supra n.1, at 27. 11EPA has recognized on many occasions that production volume is not a surrogate for exposure or even potential exposure. 12B Policy, supra n. 9, at 28,742. 

EPA must meet to support a test rule in fact is quite modest under both the ‘‘A’’ 

finding and the ‘‘B’’ finding. 

As already described, the statute only requires EPA to show that a substance may 

present an unreasonable risk, or may reasonably be anticipated to enter the environment in substantial quantities, or that there is or may be significant or substantial human exposure. When evaluating ‘‘unreasonable risk’’ under section 4, the 

EPA has stated that its determination of whether a chemical ‘‘may present’’ a hazard would not be based on definitive scientific data, but of necessity would involve 

reasonable scientific assumptions, extrapolations and interpolations. 

The EPA has also stated that it is sufficient to show that exposure may arise because of activities associated with the manufacture, use, etc. of the chemical. The 

DC Circuit Court of Appeals endorsed the Agency’s contention that the mere potential for human exposure is sufficient to support a ‘‘may present an unreasonable 

risk’’ finding under section 4.6 The minimum burden that the court required was 

that the EPA show the risk is ‘‘a more-than-theoretical probability,’’ and the court 

said that EPA may demonstrate the potential for exposure based on circumstantial 

evidence.7 Once the EPA has established this ‘‘more-than-theoretical probability,’’ 

the burden shifts to industry to rebut this by presenting evidence to the contrary. 

In 1990, industry challenged the cumene test rule which was based on a ‘‘B’’ finding. The Fifth Circuit found the EPA’s explanation of the basis for its ‘‘B’’ finding 

inadequate and remanded.8 On remand, EPA released the B Policy9 and applied it 

to the test rule that had been challenged. No further legal challenge was pursued. 

(The court had declined to stay testing, so testing had in fact already been completed.) The B Policy establishes standards and criteria for making ‘‘B’’ findings. 

EPA defined substantial production as one million pounds or more per year. EPA 

defined ‘‘substantial’’ human exposure differently for three classes of people: workers 

(1,000 people), consumers (10,000 people), or the general population (100,000 people). EPA defined ‘‘significant’’ human exposure in terms of the nature of the exposure (i.e., if the exposure is more direct than typical exposure. Since then, these criteria have proven relatively easy to apply). 

I do not agree with the suggestion that EPA should be permitted to require testing based solely on a production volume trigger and a determination that testing 

is necessary.10 Such an approach would effectively negate consideration of potential 

exposure.11 EPA’s B Policy expressly recognizes that ‘‘level, frequency, and duration 

of exposure’’ to a chemical should always be considered when determining the sufficiency of existing data and the necessity of additional testing.12 Eliminating consideration of the potential for human or environmental exposure would make it marginally easier for EPA to promulgate test rules, but it would not provide a more scientifically sound basis for making testing decisions. Such a change also would not 

be consistent with EPA’s current policies and practices under TSCA section 4. 

I do believe EPA could improve its performance under TSCA section 4 in a number of ways. EPA has issued few test rules in recent years (perhaps because substantial resources have been devoted to the HPV Challenge Program), and some 

testing proposals have languished unfinished for many years. Some suggestions for 

improvement include: 

More timely responses to industry alternative testing proposals. I have worked with 

numerous chemical industry groups that have submitted alternative testing proposals to EPA in response to testing proposals issued under TSCA section 4. The 

testing proposals have been intended to meet EPA’s objectives in a more cost-effective manner, sometimes by making greater use of existing studies. EPA has sometimes taken as much as two years to respond to such proposals. More timely responses would help improve EPA’s track record under section 4. 

More flexibility in testing approaches. Perhaps because of the time and expense 

associated with the development of proposed test rules, EPA at times has not 

seemed open to alternative approaches. I have worked with chemical industry 

groups that have proposed that EPA permit testing to proceed in phases, such that 

the companies would conduct a portion of the proposed testing initially, and then 

ask EPA to reconsider, based on the results of the initial testing, whether the bal-
66 

13947 F.2d 1201 (5th Cir. 1991). 14GAO Report, supra n.l, at 34. 

ance of the proposed testing was still necessary. These proposals have all been rejected (sometimes after an extended period of delay). In these cases, I believe more 

flexibility on the part of the Agency would have allowed testing on the subject 

chemicals to commence in a reasonable and cost-effective manner, without compromising the Agency’s ability to obtain the test data that it deemed necessary. 

I believe following the foregoing suggestions would lead to better testing decisions, 

and would improve EPA’s track record under section 4. However, I do not believe 

the statutory criteria need to be modified. I believe the criteria in the statute provide a sound basis for making scientifically appropriate testing decisions. 

There have been very few legal challenges to test rules promulgated under section 

4. Indeed, there has been relatively little litigation under TSCA generally, especially 

compared to the steady drumbeat of litigation under other environmental statutes, 

such as the Clean Air Act. The few legal challenges under TSCA section 4 have generally affirmed EPA’s broad authority to require testing. 

SECTION 6: REGULATION OF EXISTING CHEMICALS

Section 6(a) of TSCA gives EPA authority to regulate the manufacture, processing, distribution, use or disposal of a chemical if the Agency has a ‘‘reasonable 

basis’’ to believe the chemical ‘‘presents or will present an unreasonable risk to 

health or the environment.’’ Section 6 enumerates various regulatory options—from 

an outright ban to warning and labeling requirements—and provides that EPA may 

impose one or more of the enumerated requirements ‘‘to the extent necessary to protect adequately against such risk using the least burdensome requirements’’ (emphasis added). 

When promulgating rules under section 6, EPA must take into account the health 

and environmental effects of the substance, the magnitude of exposure, the benefits 

of the substance, the availability of substitutes, and the reasonably ascertainable 

economic consequences of the proposed rule. A rule promulgated under section 6 

must be supported by ‘‘substantial evidence’’ in the rulemaking record considered as 

a whole. Before EPA can regulate under section 6(a), the Agency also must determine whether the problem could be better addressed by EPA or another agency 

under another statute. 

EPA’s ability to regulate effectively under TSCA section 6 has been called into 

question over the years because of the Fifth Circuit’s decision in Corrosion Proof Fittings v. EPA,13 which overturned a ban on certain asbestos-containing products. If 

EPA cannot ban asbestos, the argument goes, then what can it ban? The Government Accountability Office (GAO) has suggested ways that the legal requirements 

of section 6 might be loosened, ostensibly to make EPA’s job easier.14 However, as 

will be demonstrated below, the failures in the asbestos rulemaking were failures 

in implementation, and not caused by deficiencies in the statute. 

EPA regulated several substances under section 6(a) during the early years of 

TSCA. Starting in 1978, EPA used section 6(a) to ban nonessential uses of fully halogenated chlorofluoroalkanes, which were used primarily as propellants for aerosols. 

In 1980, EPA issued a rule regulating disposal of wastes containing TCDD, a form 

of dioxin. In 1990, EPA issued a final rule prohibiting the use of hexavalent chromium-based water treatment chemicals in comfort cooling towers. In 1984, EPA 

issued three immediately effective proposed rules under section 6(a) to address unreasonable risks identified during the review of PMNs. The three chemical substances affected by the rules were intended for use in metalworking fluids, and EPA 

was concerned that the addition of certain nitrosating agents could lead to the formation of a substance shown to be carcinogenic in animals. Accordingly, EPA 

banned the use of nitrosating agents in metalworking fluids containing the PMN 

substances. EPA used its authority under section 5(0(2) to make the proposed rules 

under section 6(a) effective immediately. 

EPA was not as successful with its attempt to regulate asbestos. EPA’s asbestos 

rule under section 6 was promulgated in 1989 and banned most uses of asbestos 

still in commerce, including asbestos-containing floor materials, clothing, roofing 

and other building materials, pipeline wrap, friction products (e.g. brakes), and 

other automotive products. EPA also banned all new uses of asbestos, and all existing uses that were not currently in production in the United States 

In handing down its decision in Corrosion Proof Fittings, the court upheld EPA’s 

determination to proceed under section 6, instead of deferring to other Federal agencies under TSCA section 9. The court also upheld EPA’s ban on products not being 

produced in the United States currently, and the ban on unknown, future uses of 
67 

15Corrosion Proof Fittings, 947 F.2d at 1212. 16Id. at 1213 n.11. 17Id. at 1216. 18Id. at 1217. 19Notably, the court’s opinion related to after-Market brakes and the difficulty of installing 

non-asbestos replacement brakes in vehicles designed to use asbestos brakes. At the time, most 

new cars were engineered for non-asbestos brakes. 20Id. at 1224 n.25 (citing written testimony). 21Id. at 1221. 

asbestos. Concerning the bans on existing asbestos-containing products, the court 

articulated a ‘‘presumption of validity’’ in favor of EPA’s rule, and rejected a number 

of arguments advanced by industry petitioners challenging the bans. However, the 

court found such fundamental errors in EPA’s methodology and rationale for banning asbestos-containing products that all product-specific bans were struck down 

in their entirety. The asbestos rule and the court’s decision are described more fully 

in an attachment to this testimony. A few of the Agency’s errors are highlighted in 

the following paragraphs. 

Inadequate notice of a key element of EPA’s analysis. EPA used ‘‘analogous exposure’’ data—exposure data obtained under comparable circumstances to the circumstances being addressed—to calculate expected benefits of the asbestos bans. 

The court found that for some products, use of the analogous exposure estimates 

constituted the bulk of EPA’s analysis,15 and in some cases the analogous exposure 

analysis ‘‘completely altered the EPA’s calculus and multiplied four- or five-fold the 

anticipated benefits.’’16 Yet EPA did not disclose that it was relying on ‘‘analogous 

exposure’’ data until after the hearings were closed. 

Failure to justify not pursuing less burdensome alternatives. The Court found EPA 

gave inadequate consideration of less burdensome alternatives. EPA did give some 

consideration to labeling asbestos products and stricter workplace rules. However, 

the court found EPA’s analysis inadequate, because EPA ‘‘rejected calculating how 

many lives a less burdensome regulation would save, and at what cost.’’17 EPA 

failed to consider adequately the less burdensome options because it believed there 

was no level of asbestos exposure that would pose zero risk. However, as the court 

correctly noted, ‘‘Reducing risk to zero. . . was not the task that Congress set for 

the EPA in enacting TSCA.’’18 EPA misconstrued its authority under section 6— 

aiming for zero risk instead of eliminating ‘‘unreasonable risk’’—and as a result 

failed to address adequately the statutory requirement that it employ the least burdensome alternative necessary to protect against unreasonable risks. 

The court’s opinion should not be construed to require a quantitative assessment 

of the costs and benefits of every regulatory option, starting with the least burdensome, in every section 6 rulemaking. In other successful section 6 rulemakings, EPA 

has considered and rejected less burdensome alternatives without undertaking such 

a quantitative analysis. 

Inflated Estimates of Benefits. When calculating the workplace benefits of the 

bans, the court found that did not consider currently available control technologies 

that could have provided improved workplace conditions. Additionally, the court 

criticized EPA’s method of calculating the present value of future health benefits, 

which the court believed inflated potential health benefits from the product bans. 

Failure to Consider Harm From Use of Substitutes. In the case of asbestos-containing friction products (primarily replacement drum and disk brakes),19 which accounted for ‘‘the lion’s share of the proposed benefits of the asbestos regulation,’’ a 

study commissioned by EPA raised significant concerns about the effectiveness and 

potential health risks of substitute products. One of the study authors testified that 

the ‘‘replacement/substitution of asbestos-based with non-asbestos brake linings will 

produce grave risks,’’ and that ’the expected increase of skid-related highway accidents and resultant traffic deaths would certainly be expected to overshadow any 

potential health-related benefits of fiber substitution.’’20 Further, many of the EPA’s 

own witnesses conceded on cross-examination that the non-asbestos fibrous substitutes would pose cancer risks upon inhalation. Ultimately, the court concluded 

that ‘‘a death is a death, whether occasioned by asbestos or by a toxic substitute 

product.’’21 EPA could not ignore the risks and possible toxic effects of the proposed 

substitutes for asbestos once the potential concerns were brought to the Agency’s attention. 

Other equally significant errors are noted in the court’s opinion. It is apparent 

that the asbestos rule did not fail because of the requirements of section 6. As the 

court stated in its conclusion, EPA’s product-specific bans were rejected because of 

‘‘the agency’s reliance upon flawed methodology and its failure to consider factors 

and alternatives that TSCA explicitly requires it to consider.’’ One gets the impression, from reading the opinion, that the court was deeply troubled by the number 
68 

22Corrosion Proof Fittings, 947 F.2d at 1214 (citing Envtl. Defense Fund v. EPA, 636 F.2d 

1267, 1277 (DC Cir. 1980) (‘‘Under the substantial evidence standard, a reviewing court must 

give careful scrutiny to agency findings and, at the same time, accord appropriate deference to 

administrative decisions that are based on agency experience and expertise.’’’)). 23See, e.g., sections 4(a) (testing authority for existing chemicals); 5(e) (allowing regulation of 

new chemicals pending development of information); and 5(t) (allowing immediate regulation to 

prevent against unreasonable risk). 2415 U.S.C. §2601(c). 

of ways the reasoning in the final rule was skewed in favor of its proposed outcome, 

as reflected by the court’s repeated references to ‘‘flawed methodology’’ and ‘‘cursory,’’ ‘‘cavalier’’ and ‘‘meaningless’’ treatment of data. I say this not to be critical 

of EPA, but because it is important that the court’s decision not be misunderstood. 

The lesson that should be learned from Corrosion Proof Fittings is not that section 

6 cannot work. The lesson is that no matter what the product, when acting under 

section 6, EPA must consider all relevant information, conduct proper procedures, 

and present a reasonable basis for its decision. 

THE GAO RECOMMENDATIONS

‘‘Least Burdensome Requirements’’ test. GAO has suggested that TSCA section 6 

might be amended to eliminate the requirement to demonstrate that the regulatory 

option chosen is the ‘‘least burdensome requirement’’ necessary to address the identified health or environmental risks. However, before EPA bans the use of a product, 

it is not unreasonable to require the Agency to show that there is no less burdensome alternative that would be sufficient to protect human health and the environment. Stated differently, if there is a less burdensome alternative that would be 

adequately protective of human health and the environment, there would seem to 

be no justification for not using it, and no justification for banning a product that 

has proven to be valuable in commerce. Further, notwithstanding the result in Corrosion Proof Fittings, if EPA determines that a ban is the least burdensome requirement, the Agency should not be concerned that its judgments will be easily secondguessed by the courts. To the contrary, if regulations imposed under section 6 are 

based on consideration of the relevant factors, adequately explained and promulgated through proper procedures, they will receive deferential treatment by courts.22

EPA made the ‘‘least burdensome requirement’’ determination successfully in each 

of its other section 6(a) final rules. 

‘‘Unreasonable Risk’’ standard. GAO also has suggested that section 6 might be 

amended to replace the requirement to demonstrate an ‘‘unreasonable risk’’ with a 

requirement to show a ‘‘significant risk.’’ GAO indicates that finding ‘‘significant 

risk’’ would require EPA to show that the ‘‘risks are substantial or serious.’’ Moving 

from ‘‘unreasonable’’ to ‘‘significant’’ risk, however, would be inconsistent with several other provisions of TSCA, which also use the phrase ‘‘unreasonable risk’’ and 

clearly reflect congressional intent that EPA consider health and environmental impacts and social and economic impacts when regulating under TSCA.23 This congressional intent is stated explicitly in section 2(c): ‘‘[i]t is the intent of Congress 

that the Administrator shall carry out this chapter in a reasonable and prudent 

manner, and that the Administrator shall consider the environmental, economic, 

and social impact of any action the Administrator takes or proposes to take under 

this chapter.’’24

The ‘‘unreasonable risk’’ standard requires a balancing of the nature of the potential harm being addressed, the probability of the harm occurring, and the harm that 

would result from the rule. Thus, full consideration is given to the nature of the 

potential adverse health or environmental effects being addressed, and the likelihood of that harm occurring. To suggest, however, that EPA might consider imposing a ban on valuable commercial products without any consideration of the potential social or economic impacts of the ban clearly is not consistent with congressional 

intent for how EPA should implement its authority under TSCA. The asbestos rule, 

in fact, demonstrates the importance of considering the potential impacts of any 

product ban, given that there was credible evidence, supported by an EPA-sponsored 

study and EPA witnesses, that the ban on asbestos brakes for after-market use 

could cost more lives than it was projected to save. 

TSCA is by no means unusual in requiring EPA to consider potential social and 

economic impacts of its regulatory actions. For example, the Federal Insecticide, 

Fungicide and Rodenticide Act (FIFRA) requires EPA to consider ‘‘any unreasonable 

risk to man or the environment’’ and take ‘‘into account the economic, social, and 

environmental costs and benefits of the use of any pesticide.’’ Pesticides are subject 

to very rigorous scrutiny, perhaps more so than any other category of products, and 
69 

25Chem. Manuf. Ass’n v. EPA , 859 F.2d at 984. 2645 Fed. Reg. 48,524, 48,528 (July 18, 1980) (Chloromethane and Chlorinated Benzenes Proposed Test Rule; Amendment to Proposed Health Effects Standards) (’’EPA’s conclusion that the 

chemical may present a hazard will not be based on definitive scientific data. This is inevitable; 

if EPA knew in detail the types of hazards a chemical posed, there would be no need to test. 

Thus, determinations of hazard potential under Section 4 by their very nature must involve reasonable scientific assumptions, extrapolations, and interpolations.’’). 27For more details, see Battelle Report, supra n.3, at 21. 

to my knowledge the ‘‘unreasonable risk’’ standard has not prevented EPA from exercising its authority in a prudent and health-protective manner. 

In short, GAO’s suggestion that the ‘‘unreasonable risk’’ standard in section 6 be 

replaced with a ‘‘significant risk’’ standard would be inconsistent with other provisions of TSCA and contrary to clear congressional intent, and also is not necessary 

to protect human health or the environment. 

‘‘Presents or Will Present’’ Test. GAO also suggested that section 6 might be 

amended to require that EPA demonstrate only that a chemical ‘‘may present’’ an 

unreasonable risk, rather than requiring a demonstration that a chemical ‘‘presents 

or will present’’ an unreasonable risk. However, experience under section 4 of TSCA 

does not support this recommendation. Under that section, EPA has authority to require testing of a chemical that ‘‘may present an unreasonable risk’’ to health or 

the environment. As described earlier in this testimony, the ‘‘may present’’ standard 

has proven to be a very low threshold, and requires only a ‘‘more-than-theoretical 

basis for suspecting that some amount of exposure takes place,’’25 and hazard information that supports merely a suspicion of toxicity.26 Such a low standard may be 

entirely appropriate within the context of section 4, where EPA is deciding whether 

additional data should be collected. However, such a low standard would be inappropriate under section 6, where the Agency has the ability to ban a chemical. Moreover, if the ‘‘may present’’ standard were incorporated into section 6, it would be 

possible for the Agency to skip the testing step and proceed directly to a ban merely 

on the suspicion of a hazard and a ‘‘more-than-theoretical basis’’ for believing that 

exposure might be occurring, rendering section 4 meaningless. 

CONCLUSIONS ABOUT SECTION 6

There has been a tendency among critics of TSCA to judge EPA by the number 

of chemicals that have been banned under section 6. I believe that is an unduly narrow way of looking at EPA’s accomplishments —under section 6 and under TSCA 

generally. 

The EPA took a unique, but instructive approach in a case where they proposed 

a rule to prohibit the manufacture, distribution, and use of acrylamide grout to protect workers from exposure to acrylamide and another chemical. After eleven years, 

the proposal was withdrawn because the development of personal protective equipment (PPEs) made the rule unnecessary. A lower cost alternative was available to 

protect workers from exposure to the acrylamide and other chemicals in these 

grouts.27 Since EPA’s concerns were addressed, this action should be considered a 

success, notwithstanding that no ban was implemented. 

Also, as noted earlier in this testimony, EPA has used it authority under section 

5(a)(2) to issue SNURs as another way to address concerns related to Inventory-listed substances. The PFAS case described earlier is just one example; there are many 

others. 

Thus, section 6 is not the only mechanism for addressing unreasonable risks. 

Good product stewardship is a much more efficient approach and is the first line 

of defense. It is important that EPA have a means to address unreasonable risks 

when necessary, and section 6 as it is currently designed does provide that authority, but the industry must continue to act responsibly and the EPA, when it takes 

action, must do so within the statutory guidelines laid out in section 6. 

In sum, I believe EPA can regulate effectively under TSCA section 6 as it is currently written, as evidenced by EPA’s successes during the first decade after TSCA 

was enacted. EPA’s asbestos rule was struck down because in that case, EPA used 

flawed methodology and failed to consider relevant factors, not because of problems 

with section 6 itself. GAO’s suggested revisions of section 6 are not necessary, in 

my judgment, to support effective regulation, and would not improve the statutory 

framework for making regulatory decisions. I believe the language of section 6 provides a sound basis for EPA decision-making, and does not impose unreasonable 

burdens on the Agency. To the contrary, it highlights the key factors that should 

be considered by EPA when contemplating whether to ban or restrict the use of 

products. 
70 

CONCLUSION

Thank you for giving me the opportunity to testify today. In my judgment, TSCA 

is a well- crafted statute and provides the EPA ample authority to achieve the objectives set forth in the statute. EPA has accomplished a great deal over the years 

under TSCA (including under section 8, though not discussed in this testimony). I 

believe EPA could accomplish even more through improved implementation, but I 

do not believe revisions to the statute are necessary. I hope you find this testimony 

helpful in your deliberations. 

RESPONSES BY WILLIAM K. RAWSON TO ADDITIONAL QUESTIONS

FROM SENATOR INHOFE

Question 1a. Is it true that EPA must demonstrate an actual risk before it can 

issue an order, regulate or prevent a new chemical from being introduced? Section 

5(e) says that EPA must demonstrate that a chemical ‘‘may present’’ a risk. 

Response. EPA does not have to demonstrate an actual risk before regulating a 

chemical under section 5(e). That section gives EPA authority to prohibit or limit 

the manufacture and use of any new chemical substance where: (1) existing information is insufficient to permit a ‘‘reasoned evaluation’’ of the substance’s health 

and environmental effects; and (2) either the substance may present an unreasonable risk of injury to health or the environment, or the substance will be produced 

in substantial quantities and there will or may be substantial human or environmental exposure. Thus, EPA may act under section 5(e) based on information showing only that a new chemical substance ‘‘may present’’ a risk, or information showing that there will or ‘‘may be’’ substantial human or environmental exposure. 

Question 1b. Is that too high a bar? 

Response. No. In my judgment, the findings that are required are quite reasonable, and this conclusion is supported by the fact that EPA has made those findings 

and used its authority to regulate chemicals under section 5(e) on numerous occasions. Indeed, as described in my written testimony, EPA has imposed substantial 

controls or effectively prohibited the manufacture of more than 3200 chemical substances. This number includes more than 1500 premanufacture notices (PMNs) that 

have been withdrawn in the face of impending EPA action. 

It is possible that fewer PMNs may be withdrawn in the future, because EPA has 

developed a guidance document that identifies numerous chemical categories of concern, and identifies the type of test data that typically will be required for a PMN 

substance in each category. This means that industry now has a better understanding than it did when TSCA was enacted concerning EPA’s views about which 

types of chemicals are likely to present the greatest concerns. The result is that 

fewer PMNs may be submitted for some categories of chemicals. In this way, EPA’s 

implementation of TSCA is having an impact in many cases without a PMN ever 

being filed. 

Additionally, as is described in my testimony, a PMN submitter may file objections with EPA to a proposed 5(e) order, and EPA is then forced to go to court to 

obtain an injunction to prohibit or limit the manufacture or use of the PMN substance. To my knowledge, no PMN submitter has ever forced EPA to go to court to 

obtain such an injunction. In other words, no PMN submitter has ever challenged 

a 5(e) order judicially; the PMN submitter in every case has either complied or withdrawn the PMN. This means in every case EPA’s data requirements and control requirements have been met, or the PMN has been withdrawn. 

Question 2a. Why not require a base set of testing for each new chemical for 

which a PMN is submitted? 

Response. Commercial chemicals are not all alike. Any base set of testing that 

might be chosen would be too much for some new chemicals, and not enough for 

others. Under the current approach, EPA is able to get the data it needs for each 

chemical, based on EPA’s scientific judgments in each case. As described in my testimony, the majority of new chemicals in fact either qualify for an exemption from 

PMN requirements, or are relatively easily screened out based on information provided in the PMN. Requiring the development of additional test data for these substances would serve no useful purpose, and in fact would be counter-productive, because it would clog the new chemical review system and consume substantial EPA 

resources reviewing the data submissions. 

It is important to understand that the PMN submitter has an incentive to provide 

whatever data EPA requests —whether that consists of a ‘‘base set’’ of testing or 

something greater. That is the only way to get to market. There may be discussion 

back and forth with the Agency concerning what data are really needed, but at the 
71 

end of the day, the PMN submitter must meet EPA’s data requirements to get to 

market. Stated differently, if a chemical has made it to market, that means the 

PMN submitter has met EPA’s data requirements and demonstrated to EPA’s satisfaction that there will be no unreasonable risks to health or the environment. 

As stated in my testimony, the strength of section 5 of TSCA lies in its flexibility. 

EPA is given discretion to vary its assessments and testing requirements for new 

chemicals according to the attributes and expected uses of each substance. This 

flexibility promotes the efficient use of EPA resources and avoids imposing unnecessary burdens on industry, while giving EPA the authority it needs to ensure that 

the introduction of new chemicals into commerce does not pose unreasonable risks. 

I am not aware of any evidence that EPA has exercised its discretion in a way that 

has led to inadequate review or inadequate control of new substances. I see no justification for taking that flexibility away by prescribing a base set of testing that 

must be performed for all new substances, whether needed or not. 

There has been some suggestion that commercial chemicals regulated under 

TSCA should be held to the testing standards applied to pesticides under FIFRA. 

Dr. Goldman in her written testimony refers to the ‘‘reasonable certainty of no 

harm’’ standard applied to food use pesticides (but not other pesticide products), and 

she suggests that such a standard should be applied to commercial chemicals under 

TSCA. However, pesticides are very different from commercial chemicals regulated 

under TSCA, because all pesticides are designed to be biologically active—to kill 

pests or invasive plants. They also are intentionally released into the environment, 

and many are used on our food supply. It typically takes more than ten years and 

tens of millions of dollars to conduct required testing and bring a new pesticide active ingredient to market, and the burden on EPA resources who must review all 

the data submissions are enormous. EPA typically takes more than three years to 

review a new active ingredient for which a pesticide registration is sought. 

It would be completely impractical to take such an approach with all commercial 

chemicals, and EPA’s experience under section 5 shows that it is not necessary. As 

noted in my testimony, commercial chemicals vary widely in their attributes and potential uses and exposures, and the vast majority of chemicals qualify for an exemption or are readily determined not to pose unreasonable risks. Thus, a FIFRA-like 

approach to new (or existing) chemicals under TSCA is both unnecessary and would 

have a severe adverse impact on chemical innovation. 

Dr. Goldman also asserts that ‘‘TSCA does not require the protection of sensitive 

populations, including children.’’ That is not a correct statement. TSCA requires 

EPA to protect against unreasonable risks to human health, and that includes children and other potentially sensitive subpopulations. The suggestion that EPA managers and staff don’t consider risks to children absent an explicit mandate from Congress is not fair to EPA managers and staff, nor is it supported in any way by past 

experience. Test rules promulgated under TSCA section 4 have consistently included 

testing aimed specifically at chemical risks to children, and EPA chemical assessments always encompass all relevant (i.e., potentially exposed) populations. EPA’s 

IRIS assessments (described further below), for example, explicitly are intended to 

identify exposure levels that can continue for a lifetime without appreciable risk to 

the general population, including sensitive subgroups, including children. EPA takes 

the same approach under TSCA. 

Question 2b. Do you consider EPA’s use of models to review new chemicals adequate? 

Response. Yes. We are well beyond the age when every chemical must be tested 

separately. EPA has gained a lot of experience reviewing chemicals during the first 

30 years of TSCA, and its current use of models and SAR (structure activity relationships) is efficient and also health protective. Any research or study that might 

be done to improve on models is good, but I believe EPA’s current use of models 

is effective and scientifically appropriate. I have seen no evidence to the contrary. 

It is important to recognize that models of all kinds are typically applied by EPA 

in a conservative fashion, meaning that hazards, exposures and/or risks are likely 

to be overestimated, not under-estimated. This is true under TSCA but also other 

environmental statutes. Such an approach is inherently health protective, and it 

also gives industry an incentive to collect chemical-specific data if they believe true 

risks are likely to be lower than risks estimated through the use of models. 

Question 3a. Why hasn’t EPA tested more than 200 or so chemicals under section 

4? 

Response. Focusing on the number of chemicals that have been the subject of test 

rules or consent orders under TSCA section 4 is misleading for several reasons. 

First, a much larger number of chemicals have been screened for testing by EPA 

or the Interagency Testing Committee (ITC) and determined to be low priority for 
72 

testing or not to require further testing at all. Second, testing of many more substances has occurred on a voluntary basis without the need for a test rule or consent 

order. The High Production Volume (HPV) Challenge Program, which involved more 

than 2100 substances, is one obvious example that has been described in written 

testimony. Third, industry over the years has conducted a large volume of testing 

on its own, without the need for any action under TSCA section 4 or any structured 

voluntary program. Thus, focusing on the number of chemicals subject to formal action under section 4 does not give an accurate picture of the number of substances 

that have been tested over the years, or the amount of test data that is available. 

By way of example, EPA maintains a publicly-available Integrated Risk Information System (IRIS) which includes toxicity assessments of various commercially important substances. EPA does not include a substance in the database unless there 

is sufficient test data to support such an assessment, and each assessment typically 

includes a determination of a safe daily exposure (oral, inhalation or both) that may 

be repeated for a lifetime without appreciable risk to the general population, including children. There currently are more than 500 compounds in the IRIS database. 

The toxicity assessments for some compounds run fifty to a hundred pages, and include citations to hundreds of studies. Moreover, it well-known that there are many 

more substances for which similar amounts of data are available but that have not 

yet been included in the IRIS database, simply because it takes time to do so. 

Thus, testing that has been conducted under TSCA represents a small fraction of 

the toxicity information available to support assessments of commercial substances. 

This is as it should be, because industry has always conducted a substantial amount 

of testing on its own initiative, including before TSCA was enacted, and of course 

a large volume of testing is conducted every year by non-industry researchers as 

well. 

Question 3b. Do you think the requirements of section 4 are the reason EPA has 

not required more testing? In other words, do you think the findings required by 

the statute are an impediment to testing? 

Response. No. The statute requires EPA to show that a substance may present 

an unreasonable risk (the ‘‘A’’ finding), or that it may reasonably be anticipated to 

enter the environment in substantial quantities, or that there is or may be significant or substantial human exposure (the ‘‘B’’ finding). 

Thus, the burden of proof that EPA must meet to support a test rule in fact is 

quite modest under both the ‘‘A’’ finding and the ‘‘B’’ finding. Moreover, in practice 

EPA has set very low thresholds for making these findings, and EPA’s approaches 

have largely been upheld in the few reported court decisions, as described in my testimony. 

Dr. Goldman asserts that ‘‘the analytic burden required of EPA to write TSCA 4 

Test Rules and to defend them from litigation has resulted in a situation such that, 

repeatedly, over the past two decades, the Government Accountability Office (GAO), 

the Congress, and others have noted a lack of productivity and the absence of a 

clear agenda for testing.’’ I would like to make three points in response to this statement. First, these assessments by GAO and others fail to recognize the large body 

of testing that has been conducted outside TSCA (see discussion above). Second, Dr. 

Goldman does not point to any particular aspect of the ‘‘analytic burden’’ that is a 

problem. In reality, as shown above, the statutory findings that are required are 

quite modest, and if applied correctly, the statutory criteria are well-designed to 

support sound testing decisions. Third, while legal challenges are not uncommon 

when an agency implements a new program, in fact there have been very few legal 

challenges to TSCA test rules, and the decisions of the courts have affirmed EPA’s 

broad discretion to require testing. Thus, the implication that a litigation threat has 

impaired chemical testing programs is not accurate. 

I also do not agree with the GAO’s suggestion that EPA should be permitted to 

require testing based solely on a production volume trigger and a determination 

that testing is necessary. Such an approach would effectively negate consideration 

of potential exposure. (EPA has repeatedly recognized that production volume is not 

a surrogate for exposure information.) EPA’s B Policy expressly recognizes that 

‘‘level, frequency, and duration of exposure’’ to a chemical should always be considered when determining the sufficiency of existing data and the necessity of additional testing. Eliminating consideration of the potential for human or environmental exposure would make it marginally easier for EPA to promulgate test rules, 

but it would not provide a more scientifically sound basis for making testing decisions. Such a change also would not be consistent with EPA’s current policies and 

practices under TSCA section 4. 

I do believe that EPA could improve its performance under TSCA section 4, and 

have offered some suggestions in my testimony, but I do not believe the findings 
73 

required by section 4 are the problem, and I do not believe amendments to section 

4 are necessary to meet the objectives of the statute. 

RESPONSE BY WILLIAM K. RAWSON TO AN ADDITIONAL QUESTIONS

FROM SENATOR JEFFORDS

Question 1. Mr. Rawson, it is my understanding that other countries require 

chemical companies to provide basic chemical data on new chemicals to regulators. 

In addition, the European Union is about to require that chemical companies provide similar data on chemicals already in commerce. Shouldn’t chemical companies 

provide similar information to EPA? 

Response. Respectfully, I believe EPA is already getting the information it needs 

for new and existing chemicals, including information well beyond ‘‘basic chemical 

data’’ in many cases. 

Accordingly, I believe the suggestion that a basic data set be required by statute 

in the United States for all new and existing chemicals is not necessary. 

For the reasons expressed above and in my written testimony, I believe EPA currently has ample authority under TSCA sections 4 and 5 to require chemical manufacturers to conduct testing and submit information sufficient to support sound safety assessments of new and existing chemicals. The amount of information that is 

required will vary from one chemical to the next (whether new or existing), and that 

is entirely appropriate, because chemicals vary widely in their physical properties, 

chemical structures, environmental persistence, potential to bioaccumulate, potential toxicities, expected uses, and potential exposures. For many chemicals, EPA has 

collected data that far exceeds what might be considered ‘‘basic chemical data.’’ In 

other cases, EPA will decide that very little additional information is required, beyond what typically is supplied with a PMN, as happens with many new chemicals 

under section 5. 

No new chemical can get to market without meeting EPA’s data requirements, so 

there is no ‘‘data gap’’ for new chemicals. If something less than a ‘‘base set’’ of data 

was required to support a PMN, then something less than a base set of data was 

sufficient to meet EPA’s requirements. That obviously will be the case for any chemical that qualifies for an exemption from the PMN filing requirements, and there 

are many such chemicals. 

Under the HPV Challenge Program, EPA now has a base set of screening data 

for more than 2100 HPV chemicals, so the goal of a base screening set also largely 

already has been met for the vast majority of existing chemicals that are in commerce in significant volumes. Importantly, this program allowed for exercise of 

sound scientific judgment, such as the grouping of substances by relevant categories, 

so that separate testing of each chemical could be avoided where such individual 

testing was not scientifically necessary. Such chemical groupings obviously avoid the 

unnecessary use of laboratory animals, but they also save on EPA resources that 

otherwise would be expended reviewing redundant test data, and they allow testing 

programs to be completed more efficiently and in less time. The HPV program has 

been extended in a voluntary industry effort on new HPV chemicals identified in 

the 2002 TSCA inventory, and also to add exposure information to hazard information that has already been collected. Thus, through this voluntary program and 

other testing that has occurred over the years, EPA and U.S. industry have largely 

already out-performed any requirement to generate a base set of test data for existing chemicals. 

I do not think it would be wise for Congress to replace the current flexible approach with a statutory ‘‘one-size fits all’’ approach for all new or existing chemicals. 

Any such prescriptive approach is certain to miss the target more often than it hits 

the target, because commercial chemicals vary so widely, as already described. 

Moreover, it would be difficult in such a prescriptive approach to address issues 

such as the one described in the preceding paragraph, pertaining to when chemicals 

can be tested by group, rather than individually. Those kinds of decisions cannot 

be made by statute, but require scientific judgment applied to the facts of each case. 

EPA must have the flexibility to avoid unnecessary testing and the unnecessary use 

of laboratory animals. 

STATEMENT OF LYNN R. GOLDMAN, PROFESSOR, ENVIRONMENT HEALTH SCIENCES, 

JOHN HOPKINS UNIVERSITY, BLOOMBERG SCHOOL OF PUBLIC HEALTH

Mr. Chairman and members of the Committee on Environment and Public Works, 

it is my honor to testify today about the Toxic Substances Control Act. 
74 

I am a pediatrician and a professor of environmental health at the Johns Hopkins 

Bloomberg School of Public Health. I also serve as chair of the Board for the Children’s Environmental Health Network and member of the Board of Trustees of Environmental Defense. From 1993-98, I served as Assistant Administrator for Prevention, Pesticides and Toxic Substances at the U.S. Environmental Protection Agency 

(EPA). While serving in that position I was responsible for the implementation of 

the Toxic Substances Control Act. Prior to joining the EPA I worked for eight years 

in public health with the California Department of Health Services. However, my 

testimony represents my own views and not the views of these other organizations. 

When TSCA was passed in 1976, there were great expectations that it would improve our understanding of chemical risks and address these risks in a comprehensive multi-media framework. But, for a variety of reasons, TSCA has not been able 

to fully live up to these expectations. It is ironic, then, that TSCA has not been the 

subject of significant legislative action since its passage. In fact, TSCA is probably 

the EPA statute that has seen the least change in the last 30 years. The people in 

the Toxics program at the EPA do an excellent job with the tools that they have 

but they have neither the legislative tools nor the resources that are needed. There 

are several symptoms that all is not well with TSCA. First is the rising tide of 

chemicals being regulated on a State-by-State basis. While I support the right of 

states to take action to protect their citizenry only Federal actions protect all U.S. 

citizens. Second is the enormous gap that is forming between TSCA and the new 

chemicals legislation (REACH) in the European Union. And third is the dwindling 

away of personnel and resources in the EPA devoted to core TSCA efforts. 

Today, I will focus on a discussion of a number of areas of concern —and opportunity for change. These include: risk evaluation, protection of vulnerable populations, risk management, precaution, new chemicals, right to know, pollution prevention, international management of chemicals and priority-setting. 

RISK EVALUATION

To evaluate risk requires the availability of data on hazards and exposures. The 

Chemical Testing Program was established to carry out the policy expressed in 

TSCA that adequate data should be developed with respect to the health and environmental effects of chemical substances and that the development of these data 

should be the responsibility of chemical manufacturers and processors. Unfortunately the analytic burden required of EPA to write TSCA 4 Test Rules and to defend them from litigation has resulted in a situation such that, repeatedly, over the 

past two decades, the Government Accountability Office (GAO), the Congress, and 

others have noted a lack of productivity and the absence of a clear agenda for testing. EPA has tried to overcome this problem in a number of ways, including: use 

of Enforceable Consent Agreements rather than test rules; development of a Master 

Testing List and voluntary approaches for 

screening high volume chemicals in cooperation with the chemicals industry and 

the OECD (Organization for Economic Cooperation and Development). These voluntary programs are good programs but it is not at all clear how and when EPA 

will move from screening to more extensive testing of chemicals for adverse 

endpoints. 

Another important information gathering provision is TSCA Section 8(e), a critically important information-gathering tool that serves as an ‘‘early warning’’ mechanism for keeping the Agency apprised of significant new chemical hazards and exposures, and for satisfying the public’s right to know about these hazards. EPA’s longstanding policy has been, appropriately, that if certain serious health effects are discovered, that information should be considered for immediate reporting to EPA 

without further evaluation. Over and over again, across the decades, it comes to 

pass that companies may misinterpret TSCA Section 8(e) and EPA’s corresponding 

policy. EPA has tried to remedy this situation in several ways including by providing guidance documents and via the voluntary Compliance Audit Program (CAP) 

which, in 1992, allowed participating companies to submit delinquent Section 8(e) 

information and pay stipulated penalties up to a $1 million ceiling. Yet, this problem has recurred again and again. Some recent examples of significant information 

being withheld from EPA include: chromium, diacetyl and PFOA. 

EPA collects little to no information about chemical exposures yet such information is essential to the evaluation of risk. TSCA needs to be reformed to give EPA 

clear expectation for testing of risks of existing chemicals. TSCA also needs to provide for exposure monitoring, by EPA or in collaboration with others such as the 

CDC. The structure of TSCA should reward companies for the generation of information about chemicals and exposures, through more rapid approvals and/or avoidance of penalties. 
75 

PROTECTION OF VULNERABLE POPULATIONS

TSCA does not require the protection of sensitive populations, including children. 

Several other statutes, the Clean Air Act, the Safe Drinking Water Act and the Food 

Quality Protection Act all contain provisions making it clear that such populations 

should be protected. Children are often more highly extesed to chemicals in the environment, via diet, inhalation, crawling on the floor, mouthing hands and objects 

in the environment, and route such as transfer from other to baby in utero or in 

breast milk. Children are often more susceptible. ‘‘Windows of exposure’’ during development cause susceptibly to irreversible effects like birth defects, 

neurobehavioral outcomes, and other developmental alterations, and cancer. Parents 

are not aware that the products in their homes are made with chemicals, many of 

which have not been assessed at all for risks to children (or even adults). Because 

the fetus and child are often more exposed and can be more susceptible to adverse 

effects of chemicals during critical life stages, this is a particularly important vulnerable group. Other groups include people who have genetic differences in response 

or metabolism of chemicals; the elderly, and people with preexisting conditions. 

TSCA should explicitly require the protection of vulnerable populations. Exposure 

and response patterns of vulnerable populations should be 

included in risk analyses for chemicals and additional uncertainty factors employed where such information is both missing and relevant. 

RISK MANAGEMENT

In terms of managing the risks of toxic chemicals, the EPA never has recovered 

from the Fifth Circuit Court of Appeals decision to remand the 1989 Asbestos Ban 

and Phaseout Rule to EPA. In this case, the court’s decision imposed a burden of 

proof on EPA that significantly increased the level of analysis on potential substitutes and on identifying the least burdensome approach for any future Section 6 

action. Second, the court’s interpretation of least burdensome alternative under Section 6 appears to define end-of-pipe solutions, where toxic substances are controlled 

after they are distributed into the environment, as less burdensome than pollution 

prevention solutions, where toxic substances are reduced or eliminated at their 

source. End-of-pipe solutions are in conflict with the pollution prevention approach 

and are more costly over time. EPA needs for Congress to restore its ability to take 

regulatory action to manage risks of chemicals. Strengthening EPA’s ability to manage chemicals risks is this is the single most effective way that Congress could turn 

the tide on State-by-State regulatory actions on chemicals. 

PRECAUTION

Decisions about chemical risks should be made based on a stronger, more health 

based safety standard or goal. The current safety standard is to avoid ‘‘unreasonable 

risk to health or the environment’’, which means that decisions are based on risk 

benefit balancing. The standard for pesticides in food is one of a ‘‘reasonable certainty of no harm’’. This is a public health standard. Such a standard is needed for 

chemicals to which we are exposed in our daily lives, just as it is needed to protect 

us from residues of pesticides in food. Additionally, existing chemicals on the market 

should be reviewed to assure that they are safe. Certain categories of chemicals, 

such as persistent chemicals should be given highest priority (as has been done by 

Canada). Such a precautionary approach would tend to shift the ‘‘burden of proof’ 

onto manufacturers, to prove that chemicals are safe rather than on EPA to prove 

that they are unsafe. Such an approach is in contrast the ‘‘least burdensome’’ provision of current law, which made the banning of asbestos impossible. 

NEW CHEMICALS

Section 5 of TSCA requires that anyone who intends to manufacture or import 

a new chemical substance in the United States notify EPA 90 days before commencing that activity. The EPA new chemicals program has over the years reviewed 

thousands of new chemical substances. In many cases EPA has made decisions to 

prevent risk before a harmful substance enters commerce. The United States’ new 

chemicals program is unique in that it requires review of chemicals prior to manufacture rather than prior to marketing as in most other countries with such systems. I think that there is general agreement among the chemicals regulators 

worldwide that what would make more sense is a system that gives different types 

of approvals for R&D and for marketing chemicals. This would help the EPA focus 

more efficiently on the chemicals which are actually destined for the market. In the 

case of TSCA, the thousands of chemicals that are submitted and the 90-day review 

period are challenging. On top of that, the new chemicals program in the United 
76 

States does not require any testing prior to PMN submission and therefore over half 

of all PMNs are submitted without any test data. Ever resourceful, the Agency has 

developed tools to use Structure Activity Relationships (SAR) to predict and assess 

the fate and effects of new chemicals. Other systems, most notably the ‘‘preREACH’’ Pre-marketing Notification scheme used in the European Union (EU), require a ‘‘base set’’ of testing on new chemicals. In the 1990s the United States and 

EU evaluated the utility of SAR and found that it worked for some endpoints but 

not others, particularly a number of chronic health effects. 

When EPA determines that there is a risk associated with a PMN it has tools 

that can be used to manage those risks. TSCA Section 5 gives EPA the ability to 

require additional tests or other measures such as disposal controls and worker protection. Over the years, the new chemicals program has made wonderful efforts to 

inform the chemical industry about the criteria used to assess chemicals. These efforts have encouraged development of safer chemicals, and I believe have caused the 

industry to screen out ‘‘bad actors’’ before presenting them to the EPA in the first 

instance. 

TSCA’s new chemical provisions would be improved if EPAs effort were focused 

premarket rather than premanufacture approvals and would benefit greatly from 

the addition of risk related data to the agency’s determinations. 

RIGHT TO KNOW

Empowering the public with information is a powerful tool for environmental 

progress. The creation of the Toxics Release Inventory (TRI), established in Section 

313 of the Emergency Planning and Community Right-to-Know (EPCRA), led the 

way to a new era of public disclosure and a more constructive dialogue between citizens and industry on emissions reduction and pollution prevention. For a toxic 

chemicals program, it is almost inevitable that the ‘‘right to know’’ ethic will expand 

to other chemical information. The public release of environmental data gives everyone the ability to participate in the broader national effort to set a toxics agenda 

and address chemical issues based on the extent of risk posed. The states, local Governments, industry, labor unions, public interest groups and grass-roots community 

groups are increasingly finding ways to work together on environmental improvements. All problems of chemical management cannot be solved through direct EPA 

action. As one example of this, the EPA has unsuccessfully attempted to foster and 

enhance the participation of individual states in chemical management by providing 

them with TSCA derived chemical data. As a former State regulator, I know the 

value of site specific information in risk assessment and priority setting. Yet, the 

language of the law has been interpreted to say that such information cannot be 

shared with State officials if it has been declared as ‘‘confidential business information’’. In relation to this problem, there is a large amount of information reported 

to the EPA under TSCA information claimed as confidential business information; 

studies have found that much of which does not deserve such protection. 

EPA has attempted to reform the CBI process but such efforts have foundered on 

resource limitations and the language of the law, which gives manufacturers too 

much leeway. Some examples from a survey of the data conducted by EPA in 1998: 

• In 1998, more than 65 percent of the information filings directed to the Agency 

through TSCA were claimed as confidential. • Submissions under the former Inventory Update Rule show that about 20 percent of facility identities were claimed as confidential. • In 1998, 40 percent of Section 8(e) substantial risk notices had chemical identity 

claimed as confidential. 

There is a need to reform the CBI provisions in TSCA. Also Congress needs to 

rethink the role of the states, which has expanded greatly since 1976, and identify 

ways to provide them not only with more information but also with more opportunities to participate in chemicals management efforts 

POLLUTION PREVENTION

Preventing pollution offers significant opportunities for protecting the environment and public health in a cost effective manner. The adoption of a pollution prevention ethic is a logical development in a toxic chemicals program, given the focus 

on improving environmental protection through changes in the manufacture, processing and use of chemicals in our society. Fundamentally, we need to encourage 

use of safer chemicals and processes in our industrial sector. In order to achieve this 

TSCA would need to be altered in a number of fundamental ways. First, EPA needs 

stronger coordination among its ‘‘media’’ offices when it comes to chemicals to prevent the movement of harmful substances from air to water to waste. Second, TSCA 

does not reward the development of newer safer alternatives. Newer chemicals are 
77 

reviewed more carefully than existing ones and the lack of regulation of hazardous 

existing chemicals does not create an incentive to remove them from the market. 

Congress needs to examine ways to create incentives for greener chemicals and 

chemical use patterns. TSCA should support and reward companies for research and 

development and for creating safer substitutes through tools such as exemptions 

and more rapid approvals for market. TSCA should be a tool to break down the 

‘‘silos’’ at EPA to assure that chemicals are managed properly from cradle to grave 

and not inappropriately shifted from one medium to another (for example, from 

water to air). 

INTERNATIONAL MANAGEMENT OF CHEMICALS

Increasingly it is recognized that a number of very persistent and/or very hazardous chemicals need to be managed globally. In 1992 the Rio Conference adopted 

Agenda 21, which contained a number of goals for international management of 

toxic substances. Since that time we have seen the development of many new institutions including: the InterGovernmental Forum on Chemical Safety, a global treaty 

on prior informed consent for the import of highly toxic chemicals (the Rotterdam 

convention or PIC) and the global treaty on Persistent Organic Pollutants (POPs). 

Yet the United States has been slow to join these issues and in fact has not ratified 

the POPs and PIC conventions. A ‘‘clean’’ approach to ratification is needed so that 

the United States can fully participate in these important efforts to protect the 

health of the global community. 

PRIORITY SETTING

Because there are so many chemicals on the market that have yet to be evaluated, what is needed is for Congress to set a clear agenda for priorities in evaluation 

and management of chemicals, as well as clear expectations for action. Some factors 

that might be considered include: 

• Children’s exposure pathways and uses that are likely to expose children • Biomonitoring and environmental data; which chemicals are in peoples bodies • Cancer, developmental, reproductive and ecological effects and chemicals classes 

associated with such effects • Higher production volumes • Bioaccumulative or environmental persistence properties • Use patterns; chemicals uses more likely to result in exposures to humans and 

the environment 

CONCLUSION

In summary, overhaul of TSCA is long overdue. The Kids Safe Chemicals Act of 

2005 is an effort that takes the debate in the right direction. EPA needs clear requirements and regulatory authority that requires placing a high priority on protecting health (especially for vulnerable populations) and the environment. Minus 

congressional action on TSCA we will continue to see the erosion of Federal management of chemicals on many levels. We will see more states taking action to manage 

chemicals, thereby creating confusion in the markets and unequal levels of protection State by State. We also will continue to see the dwindling down of activities 

on the Federal level with a commensurate increase in the risk that ‘‘bad actors’’ will 

get through the net. And we will increasingly see the European Union and others 

move into the lead in this area, thus putting us at a competitive disadvantage. This 

is a complicated area but at the end of the day there is one simple principle that 

should be kept foremost, which is assuring the American public that the products 

on the market, the air they breathe, the food and the water, are safe. 

RESPONSES BY LYNN R. GOLDMAN TO ADDITIONAL QUESTIONS

FROM SENATOR INHOFE

Question 1. Doctor Goldman, during the hearing we had an exchange about animal testing in which you suggested that there were other methods besides animal 

testing that might be utilized to determine health effects of chemicals. Can you provide specific examples of types of testing that does [sic] not involve animals or humans? How do these tests differ from modeling? 

Response. Senator Inhofe, there are a variety of ways to generate data that provide information about toxicity of chemicals. Given the vast numbers of chemicals 

that need to be assessed, it makes sense to employ a tiered testing framework. The 

framework which was developed by the EPA along with stakeholders in the Endocrine Disruptor Screening and Testing (EDST) Advisory Committee (which I chaired 
78 

1996-98) provides an illustration of how such an approach can work to utilize methods besides animal testing in a logical fashion-(Figure 1). Although this framework 

was developed for the detection of health effects related to endocrine disruption, 1 

believe that the general concept of a tiered approach that we developed for the 

EDST framework can very logically be extended to other types of toxicity to human 

health and the environment. Moreover, this framework was supported by scientists 

from various disciplines as well as by all of the involved stakeholder groups. 

The way that such a tiered approach can work is that initially chemicals can be 

sorted and some chemicals can be removed from further consideration on the basis 

of unlikelihood of exposure (the boxes labeled ‘‘polymers’’ and ‘‘exempted’’ chemicals), very low to no production volume, or having already been assessed. Such 

chemicals can initially be prioritized using information such as chemical structure, 

physical properties, structure activity relationships (SAR). production volume, conditions of use, permitted uses, and existing toxicology studies; no new animal studies 

would be required at this stage. Of these tests, only one (SAR) involves the use of 

modeling. For endocrine disruption it was determined that a cutoff for ‘‘high’’ production volume would be >10,000 lbs/year, far lower than the one million lb cutoff 

for the HPV program. Under the EDST program such chemicals would be subjected 

to high throughput prescreening (HTPS) tests; these are in vitro tests that use cellculture based assays (but not animals or SAR models) to provide a further indicator 

of whether a chemical is a priority for further assessment. For the EDST program 

at this point chemicals can be judged low priority, can go directly to hazard assessment, or can be prioritized for Tier 1 screening or Tier 2 testing. Tier 1 screening 

involves 13 tests, six of which are in vitro (and therefore do not use animals), two 

of which use nonmammalian species (tadpoles and fish), and two of which use smaller numbers of animals than conventional tests. Again, after Tier 1 screening chemicals are prioritized for whether or not any further action is needed, and, if so, if 

that would involve hazard assessment or proceeding to Tier 2 testing. All five of the 

tests in Tier 2 involve the use of animals, however only one uses mammals (rats) 

and the others use, respectively, Japanese quail, frogs, fish and an invertebrate 

called mysid shrimp. Using nonmammalian species is not only more humane but 

also assures that the chemicals with the greatest potential for hazard are tested in 

species that are of economic and ecological importance to humankind, such as fish, 

birds and shrimp and/or most sensitive to ecological damage, such as frogs. In any 

case, by using a tiered approach the chemicals that wind up in Tier 2 are those for 

which the value of information is highest, thus (in my view) more clearly justifying 

the use of animals. 

This example illustrates how much information potentially can be made available 

prior to requiring testing and that it is possible to focus the use of animal tests only 

on the chemicals that are most likely to be ‘‘bad actors’’. This example was for endocrine disruptors because the 1996 Food Quality Protection and Safe Drinking Water 

Acts required that EPA develop such a screening and testing program. However, the 

basic approach could be applied much more generally and with appropriate legal authority the Federal Government could inform us about risks to a much greater extent than we are today. 

Question 2. Assuming that some types of biological effects information can only 

be gleaned by testing on biological specimens, i.e. animals. Do you have any concerns about [sic]. 

Response. At this time there are indeed biological responses that can be assessed 

only via testing on whole biological systems, animals. At the same time, knowledge 
79 

is rapidly advancing and new scientific approaches under development in the areas 

of genomics, proteomics, and metabolomics perhaps some day will lead to the development of testing technologies that can replace animal testing, in whole or in part. 

Even today, in vitro testing can be used to rapidly screen and assess chemicals and 

to determine which chemicals are a higher priority for further testing, and which 

are not. 

Given how slowly we have made progress to assess risks of chemicals I am concerned that some might invoke concerns about testing on animals to justify our failure to assess the toxicity of most chemicals to which we, and our children, are exposed. At the same time that we take steps to develop new strategies to minimize 

use of animals and to find ways to assess hazards of novel substances like products 

of nanotechnology, we also need to increase our knowledge about the hazards of 

chemicals in our environment. These efforts can go hand in hand. Any new alternative methods must be consistent with sound scientific practices necessary to obtain valid results, while addressing the ‘‘3 R’s’’, reduction, refinement, and replacement, of alternatives to animals testing. Reduction involves development of methods 

that reduce the number of animals required for a test method. Refinement involves 

development of methods that lessen or eliminate pain or distress in animals or enhance animal well-being. Replacement involves development of methods that replace 

animals with non-animal systems or replace an animal species with a 

phylogenetically lower species (for example, replacing mammals with fish or invertebrates). The process of assessing and validating new test protocols is complicated 

and requires the input of scientists from many disciplines including toxicology, statistics, exposure sciences and basic sciences such as molecular biology. 

RESPONSES BY LYNN R. GOLDMAN TO ADDITIONAL QUESTIONS

FROM SENATOR JEFFORDS

Question 1. TSCA’s Lack of Protections for Children Ms. Goldman, please describe 

some of the concerns that you have regarding EPA’s ability to use TSCA to protect 

the health of vulnerable individuals, including children? 

Response. In brief, the Toxic substances Control Act (TSCA) contains no provision 

for special consideration of risks to children and other vulnerable populations. We 

know that, at various life stages, children are more exposed to chemicals that occur 

in drinking water, in certain foods, in air, in dust and dirt and in certain products 

such as toys. They may have slower —or faster metabolism or elimination of substances during various developmental stages. We also know that during fetal and 

early childhood development there is the potential for irreversible harm to occur, via 

mechanisms birth defects, adverse impacts on the developing brain or growth, immune system effects and increased cancer risk. The law should require that the 

EPA consider the juncture between exposure and vulnerability during the development of a child. In addition, there are many other vulnerable individuals in the population: people with increased risk on a genetic basis; the elderly; and those who 

are severely ill and/or immunocompromised. Some suggestions are: 

• Clear requirements that EPA place a high priority on protecting children’s 

health and on protecting other vulnerable subpopulations. • A strong safety standard, such as a ‘‘reasonable certainty of no harm’’ • Health protection of children is the basis for chemical regulatory decisions. • An additional safety margin for children, pregnant women, the fetus, nursing 

women, and women of child-bearing age 

• Recognition of and protection for children most at risk, including children of 

lower socioeconomic status, children of racial and ethnic minority status, children 

with special health care needs, and children whose parents have occupational exposure to chemicals. 

• Establishment of protocols for data collection, hazard and exposure assessments 

that explicitly consider children and their most sensitive and vulnerable health effects. 

• Consideration of multiple and synergistic effects of different chemicals, of 

chemicals with multiple pathways of exposure, and of chemical mixtures. 

Question 2. Potential reforms to TSCA Ms. Goldman, please describe the aspects 

of TSCA that you would change in order to ensure that EPA has the legal authority 

to quickly stop exposure to dangerous chemical substances and to prevent such exposures, while conserving limited public resources. 

Response. First, to assure that children are adequately protected, I think that 

TSCA needs to be reformed in order to include: 

• Clear requirements that EPA place a high priority on protecting children’s 

health and on protecting other vulnerable subpopulations. 
80 

• A strong safety standard, such as a ‘‘reasonable certainty of no harm’’ 

• Health protection of children is the basis for chemical regulatory decisions and 

these decisions are based on active processes of review of information.. 

• An additional safety margin for children, pregnant women, the fetus, nursing 

women, and women of child-bearing age 

• Recognition of and protection for children most at risk, including children of 

lower socioeconomic status, children of racial and ethnic minority status, children 

with special health care needs, and children whose parents have occupational exposure to chemicals. 

• Establishment of protocols for data collection, hazard and exposure assessments 

that explicitly consider children and their most sensitive and vulnerable health effects. 

• Consideration of multiple and synergistic effects of different chemicals, of 

chemicals with multiple pathways of exposure, and of chemical mixtures. 

Second, to strengthen the EPA’s ability to protect the public from harmful chemicals, TSCA should be reformed to.. 

• Not allow exposure to chemicals that do not meet core information requirements. 

• Assure commitment to timeliness, and that protective measures are adopted by 

default if action is not taken on a timely basis. 

• Reward the generation of information about chemicals and exposures. 

• Support and reward for research, development and innovation that produces 

safer substitutes. 

• Assure collection of; biomonitoring data under appropriate scientific guidelines. 

• Require periodic review of chemicals, with more frequent review of more hazardous materials. 

• Include strong enforcement provisions including routine inspections and random 

audits of testing facilities and laboratories. 

• Give citizens the ability to file suit and to petition EPA for action on toxics. 

• Increase the public’s ‘‘right to know’’ by reform of TSCA’s overly broad confidential business information provisions 

Third, to conserve limited public resources, TSCA should be reformed to: 

• Shift the burden of proof such that the onus is on industry is to demonstrate 

safety of a chemical by supplying required data. 

• Provide a tiered approach to the assessment of chemicals in commerce. 

• Strengthen participation by State (and sometimes local) Government which 

often can act more efficiently and in a more targeted fashion than the Federal Government. 

• Strengthen role of other Federal agencies including NIEHS, NTP, and CDC, in 

biomonitoring and in assessment of hazards of chemicals. 

• Promote the ‘‘three R’s’’ (reduction, refinement and replacement) to reduce the 

burden of animal testing. 

• Promote international cooperation in the management of chemicals in commerce 

internationally 

• Assure a transition that includes a process for establishing priorities for review 

and approval of existing chemicals. Priority is to be given to ‘‘the worst first’’—after 

consideration of children’s exposures, biomonitoring data, developmental 

neurotoxicity, disparate impacts on certain populations, intrinsic properties (such as 

bioaccumulative or environmental persistence), use patterns, and production volume. 

• Assure a fair and predictable process that provides clear expectations for industry and predictable outcomes of assessment and review, so that private resources 

are not wasted as well. 

IMPACT OF APPLYING PROTECTIONS FOR CHILDREN IN TSCA

Question 3. Ms. Goldman, Congress has included protections for children and 

other vulnerable populations in numerous public health and environmental laws, including the Safe Drinking Water Act, Clean Air Act and the Federal Food, Drug and 

Cosmetic Act. 

Please describe the range of benefits that you believe would occur if Congress included similar provisions in TSCA. 

Response. The benefits are likely to be quite large. According to a study done by 

Mt. Sinai university, for the United States alone: ‘‘Total annual costs are estimated 

to be $54.9 billion (range $48.8-64.8 billion): $43.4 billion for lead poisoning, $2.0 

billion for asthma, $0.3 billion for childhood cancer, and $9.2 billion for 
81 

neurobehavioral disorders. This sum amounts to 2.8 percent of total U.S. health care 

costs.’’ 

Of these, I would expect that $9.5 billion each year (the costs attributed to childhood cancer and neurobehavioral disorders) could potentially be saved. This amount 

would increase substantially were one to add in costs attributed to exposures to susceptible adult populations as well as a number of costs that they were not able to 

assess, including costs of pain and suffering and late complications that are not yet 

well understood. [1] 

LIMITATIONS OF CURRENT PROTECTIONS FOR CHILDREN’S TOYS

Question 4. Ms. Goldman, please describe the limitations of other Federal agencies’ regulations to protect children’s health from toxic substances in children’s toys. 

In particular, please describe the critical role that EPA regulation could play in filling gaps in the regulatory scheme of other Federal agencies, such as the Consumer 

Product Safety Commission. 

Toys are regulated by the Consumer Products Safety Commission (CPSC) under 

the Federal Hazardous Substances Act. If you go to their webpage and you will find 

pages and pages of toy product recalls. However, almost all are for the (very important) goal of protecting children from injuries, such as aspiration, choking, and 

strangulation by toys. Except in the case of lead, there is little to no action related 

to chemicals in toys, even though Congress has given CPSC the authority to recall 

toys for reason of chemical risk. CPSC does not even regulate chemicals in pacifiers, 

children’s products with great likelihood of exposure. Instead, CPSC relies on voluntary efforts to achieve such protection (such as addressing hazards from nitrosamine or phthalates in pacifiers). In its defense, CPSC does not have adequate staffing and resources to address the thousands of chemicals that are in children’s products. Although the drafters of TSCA envisioned a coordinated process between EPA 

and the other regulatory agencies in reality the process by which EPA is to ‘‘refer’’ 

chemicals to other agencies does not function well. The EPA needs to be able to directly take action when it has evidence that chemicals in children’s products are a 

health risk. 

STATEMENT OF MICHAEL P. WILSON, PH.D, M.P.H, 

UNIVERSITY OF CALIFORNIA, BERKELEY

Mr. Chairman and members of the committee, thank you very much for inviting 

me to the hearing today on chemicals policy and the Toxic Substances Control Act. 

I am Michael Wilson, an assistant research scientist with the Center for Occupational and Environmental Health at the University of California, Berkeley and the 

lead author of a report regarding chemical problems in California and the steps the 

California Legislature can take to respond to those problems. I will speak briefly 

about the report, entitled Green Chemistry in California: A Framework for Leadership in Chemicals Policy and Innovation, which was published by the University of 

California in March of this year. I would like to acknowledge co-authors Daniel Chia 

and Bryan Ehlers and the Advisory Committee of experts that provided technical 

guidance and rigorous review of the document over a two-year period. 

The report responds to three questions posed to the University by the California 

Legislature: 

• What are the key chemical challenges facing California? 

• What are the causes of those challenges? 

• How might the Legislature respond to those challenges? 

In answering these questions, we found that California, like other States, is facing 

an array of problems with chemicals. These problems are experienced in different 

ways by the businesses in our State that purchase and use chemicals, by our Government agencies, and by consumers and workers. But three themes emerged out 

of our investigation. First, there is insufficient information in the marketplace to 

make informed decisions abut chemicals. Second, Government is overly constrained 

in its capacity to protect public and environmental health from chemicals. 

And third, more needs to be done to motivate investment in safer chemical technologies, known as ‘‘green chemistry.’’ 

While the focus of the report is on the challenges that exist in California, the report finds that the root cause of these challenges can be traced to longstanding deficiencies in Federal regulation, particularly with the Toxic Substances Control Act, 

or TSCA. The report illustrates that the weaknesses of TSCA have produced a Data 

Gap, a Safety Gap, and a Technology Gap in the U.S. chemicals market. I would 
82 

like to briefly explain these three Gaps and their relevance to chemicals policy in 

the United States 

The first of these, the Data Gap, is perhaps the most fundamental. As you have 

heard from other witnesses, TSCA does not require chemical producers (United 

States or foreign) to generate and disclose robust information on the toxicity of the 

vast majority of chemicals in commercial circulation. Markets cannot function without good information, and the chemicals market is no different. We found that California businesses that use chemicals are unable to identify and choose the safest 

chemicals for their needs. This leaves them with uncertainties and liabilities arising 

from the potential effects of these chemicals on their workers, on their customers, 

and in the environment. Even large firms, such as those in California’s electronics 

industry, are finding it very difficult and expensive to identify and replace hazardous chemicals in their supply chains. These firms simply do not have the right 

kind information to identify safer chemical alternatives. Of course, small business 

owners, workers, and consumers are affected even more acutely by the lack of appropriate information in the chemicals market. 

This pervasive lack of information also poses a barrier to the competitive advantage of innovative companies that are investing in green chemistry. In the current 

chemicals market, customers, investors and others are unable to efficiently differentiate between conventional chemicals and safer alternatives. The report finds that 

green chemistry will become commercially viable only when the market allows these 

entities to make informed purchasing decisions. It is one of the proper roles of Government to ensure that the market has sufficient information to function properly, 

and in this regard, TSCA has come up short. 

The second challenge recognized in the report is the Safety Gap. It is also a proper function of Government to ensure that the production and use of goods does not 

come at the expense of public and environmental health. Here again, TSCA has fallen short. It is well recognized that U.S. EPA has been greatly constrained in it ability to assess the hazards of chemicals in commercial circulation and to control those 

of greatest concern. This has allowed hazardous chemicals to remain competitive in 

the market, and it has unnecessarily put the public at risk. It is also costly. For 

example, the EPA expects that if production and regulatory practices remain the 

same, 600 new hazardous waste sites will appear in the United States each month 

of every year over the next 25 years; clean-up costs are estimated at over $250 billion. The CDC reports that about half of the top 50 chemicals at existing waste sites 

can cause birth defects; others are toxic to the human nervous system. 

Other social costs of chemical exposures are more subtle. There is evidence that 

hundreds of chemicals are accumulating in the human body. Some of these —including flame retardants, wood preservatives, and stain repellants —have been identified in the umbilical cord blood of newborn babies. Of course, the effects of chemical 

exposures during the uniquely sensitive period of human development are of great 

concern. Furthermore, chemical exposures in the workplace continue to produce a 

substantial burden of occupational disease in the United States. In California, about 

23,000 workers each year are diagnosed with chronic diseases that are attributable 

to chemical exposures on the job. The Safety Gap created by TSCA is allowing real 

problems to continue unchecked, problems that will likely expand as global chemical 

production doubles over the next 25 years. 

Together, the Data Gap and Safety Gap are contributing to stagnant conditions 

in the U.S. chemicals market. This is producing what we characterize in the report 

as a U.S. chemical Technology Gap. Only 248 new chemicals introduced since 1979 

have reached High Production Volume status in the United States, about 8 percent 

of the High Production Volume chemicals in commercial circulation today. In its 

1996 Vision 2020 report, the U.S.-based Council for Chemical Research, together 

with the American Chemical Society, the American Institute of Chemical Engineers, 

the American Chemistry Council, and the Synthetic Organic Chemical Manufacturers Association, wrote that the vast majority of chemical products are manufactured 

in the United States using technologies developed 40 to 50 years ago and that new 

technologies are needed that incorporate economical and environmentally safer processes, use less energy, and produce fewer harmful byproducts. Ten years after the 

Vision 2020 report, the websites of the 50 largest U.S. chemical companies all contain a statement of commitment to achieving sustainability goals, but their spending 

on research and development has decreased or remained flat since 2000, according 

to the National Science Foundation. 

It is not surprising, therefore, that the Committee on Grand Challenges for Sustainability in the Chemical Industry, convened by the National Academy of Sciences, 

concluded in its December 2005 report that in ‘‘going forward, the chemical industry 

is faced with a major conundrum—the need to be sustainable (balanced economically, environmentally, and socially in order to not undermine the natural systems 
83 

on which it depends)—and a lack of a more coordinated effort to generate the 

science and technology to make it all possible.’’ The committee included academic 

scientists as well as representatives of Dow, PPG Industries, ConocoPhillips, and 

Agraquest. 

The U.S. private sector is simply not investing vigorously enough in cleaner technologies, such as green chemistry, that are likely to mark the next era of innovation 

and growth in the global chemicals market. It is a reflection of the current State 

of the chemicals market (and the Technology Gap in particular) that with very few 

exceptions one can still earn a Ph.D. in chemistry at U.S. universities without demonstrating even a rudimentary understanding of how chemicals affect human health 

and the environment. U.S. chemistry graduate students are not required to gain an 

understanding of the principles of toxicology. This is a serious problem not only for 

public and environmental health but for the long-term competitiveness of the U.S. 

chemical industry itself, as noted last year by the NAS Grand Challenges committee. 

So what is to be done? First, our report acknowledges that the U.S. chemical industry generates important benefits for society in the form of an extraordinary 

array of substances serving all sectors of the economy. At the same time, our report 

finds increasing evidence that many of these substances can adversely affect human 

health and disrupt the biological systems on which life itself depends. This is precisely what makes chemicals policy so difficult. Some of the properties that make 

chemicals useful to society also make them hazardous to people. Once we acknowledge this paradox, however, we can begin to think about how to re-design the production and regulatory systems so that they amplify the positive contributions of 

chemicals to society while steadily reducing their negative impacts. This represents 

a system that is founded on the principles of green chemistry. It essentially introduces the toxicity of chemicals into the market on an equal footing with price and 

function, and in doing so it moves the market steadily toward the design, production, and use of chemicals that are inherently safer for people and ecological systems. 

In short, a fundamental overhaul of the Federal Toxic Substances Control Act is 

needed. A modern U.S. chemicals policy will need to put in place the market conditions that advance the technical and commercial viability of green chemistry. These 

new market conditions will begin to motivate the chemical industry to focus its 

enormous talent and technical capacity on innovating green chemistry at a level 

commensurate with the scale and pace of chemical production. It will open new market opportunities for green chemistry entrepreneurs. It will not, however, be 

achieved through voluntary initiatives by the industry, nor will it be achieved by 

piecemeal approaches to chemicals policy, or by providing occasional funding to universities to conduct green chemistry research. While these can help identify best 

practices, for example, they are not sufficient —even collectively —to correct the uneven playing field in the chemicals market that has been engendered by TSCA. The 

UC report recommends that correcting these market flaws will require a comprehensive approach to chemicals policy that closes the Data Gap, the Safety Gap and the 

Technology Gap. 

This is the key challenge of chemicals policy for California and the nation, and 

I think it is reasonable to conclude that it is a fairly formidable challenge. Meeting 

this challenge, however, will deliver real value to the American people. It will build 

the foundation for an economically and environmentally sustainable chemical industry in the United States; it will solve a host of costly chemical problems that are 

affecting public health, businesses, and Government; and it will support our industry leaders in becoming globally competitive in green chemistry and other cleaner 

technologies. 

Mr. Chairman and members of the Committee, thank you very much for your attention today, and thank you again for inviting me to this important hearing. I 

would be pleased to answer any question you might have. 

RESPONSE BY MICHAEL P. WILSON TO AN ADDITIONAL QUESTION

FROM SENATOR INHOFE

Question 1. Does the UC report advocate the adoption of a reach-like approach? 

THE UC REPORT DOES NOT CALL FOR THE ADOPTION OF A REACH-LIKE APPROACH

IN THE U.S. 

Response. The UC report proposes three overarching goals for chemicals policy in 

California: Close the Data Gap, the Safety Gap, and the Technology Gap. It then 

describes a number of issues that are important for policymakers to consider with 
84 

1Sensitive physiological processes can be disrupted during the rapid growth and development 

characteristic of embryonic and fetal life and the first year following birth. Development of the 

brain, for example, requires the formation and interconnection of billions of neurological cells; 

development of the endocrine system and reproductive organs is guided by a precisely timed sequence of hormones that exert their effects in the parts-per-trillion range. 2Children’s metabolic pathways, especially in fetal life and in the first month after birth, are 

immature. Among other factors, growth of the blood-brain barrier, which can provide protection 

against some chemicals, is incomplete during fetal and early child development, such that 

chemicals are able to move directly from the maternal blood stream into the developing fetal 

brain. 3Relative to their size, children’s intake of air, water, and food is far greater than that of 

adults. The amount of air a resting infant breathes, for example, is twice that of an adult, normalized by body weight. Children therefore experience disproportionately higher doses of environmental agents, including chemicals. 4Children have more years of future life than adults and thus have more time to develop diseases initiated by exposures early in life. Many chronic diseases, including cancer and 

neurodegenerative diseases, appear to arise as a result of cellular changes that take place many 

years before the actual manifestation of the disease. Critical windows of exposure to hazardous 

chemicals in utero, during early child development, and during puberty are more likely to 

produce chronic disease than similar exposures encountered later. 

respect to each of these goals (Chapter 7). The Data Gap refers to the lack of information in the market on the safety of chemicals. The Safety Gap refers to the barriers that Government faces in its efforts to assess the hazards of chemicals and 

control those of greatest concern. The Technology Gap refers to the potential for the 

United States to fall behind globally in the science, technology, and commercial applicability of green chemistry. 

We developed these three policy goals (Chapter 3) based on discussions with 

chemicals policy stakeholders in the United States, on our participation in 35 chemicals policy meetings and conferences in the United States (Appendix A), and in 

studying reports published by the National Academy of Sciences (1984),1 the U.S. 

General Accounting Office (1994),2 the Congressional Office of Technology Assessment (1995),3 Environmental Defense (1997),4 the U.S. EPA (1998), the U.S. Government Accountability Office (2005), former EPA officials, and academic researchers. These reports all point to deficiencies in the U.S. Toxic Substances Control Act 

(TSCA) that have prevented the statute from serving as an effective vehicle for Government, industry, consumers, and workers in the United States to assess chemicals 

in commercial circulation and control those of greatest concern. The UC report uses 

the terms Data Gap, Safety Gap, and Technology Gap to describe the set of conditions in the United States that have emerged as a consequence of these deficiencies. 

THE UC REPORT DESCRIBES REACH AS THE E.U.’S STRATEGY TO ADDRESS A SET OF

CHEMICALS POLICY PROBLEMS THAT ARE ESSENTIALLY IDENTICAL TO THOSE OF THE

U.S. EXPERIENCE UNDER TSCA. 

The chemicals policy deficiencies identified in the E.U. by the European Commission in its justification for REACH are essentially identical to those of the United 

States: 

• There is a lack of health, environmental, and other information on the great 

majority of chemicals in commerce; 99 percent of chemicals in commercial circulation in the E.U., by volume, lack adequate information on health and environmental 

effects. 

• There is an implicit presumption that chemicals are safe unless proven otherwise by a public entity. 

• The ability of public agencies to assess and demonstrate chemical risks has not 

kept pace with the rate of chemical production; only about 140 of 100,000 existing 

chemicals in the E.U. have been subject to risk assessments. 

The UC report indicates that an array of strategies could be employed to address 

this same set of problems in the U.S. The report devotes a chapter to a discussion 

of the experience in Massachusetts under the Toxics Use Reduction Act of 1989 

(Chapter 6), and it lists 13 different policy mechanisms that could be used to directly or indirectly limit chemical hazards. It proposes a set of attributes of the most 

effective policy mechanisms, as follows (Chapter 7): 

• meet the proposed objective in a measurable way, 

• place the least demands on Government, 

• leverage market forces, 

• leverage existing statutes and programs, 

• be cost-effective and fair, 

• consider impacts across the chemical life cycle (including the workplace), 

• ensure public access and participation, 
85 

• integrate environmental and occupational health justice factors, 

• emphasize prevention (including green chemistry) over mitigation, 

• encourage continual learning by the regulated entity, 

• motivate technology innovation and diffusion, and 

• be adaptable to change. 

The report finds that to close the Data Gap, Safety Gap, and Technology Gap, 

California will need to: (1) require the disclosure by chemical producers of more 

complete information on chemical toxicity, ecotoxicity, exposure and other information; (2) improve the capacity of Government to act in an efficient and timely manner in controlling the most dangerous chemicals; and (3) implement additional incentives that motivate industry investment in green chemistry science and technology, and devote public resources to green chemistry education, research, and 

technical assistance programs. The first two of these parallel the intent of the 

REACH proposal, whereas the third is implied but not made explicit in REACH. 

The similarities between the policy goals recommended in the UC report and 

those of REACH reflect the fact that both are responding to essentially the same 

problems; the similarities also reflect a general concern among the industry representatives we spoke with that harmonization of standards across jurisdictions is 

becoming increasingly important as these jurisdictions begin to contemplate chemicals policy strategies. To prevent a scenario in which U.S. producers are forced to 

contend with an increasingly diverse global regulatory environment, the UC report 

suggests that some aspects of REACH (such as data requirements) might be harmonized with chemicals policy initiatives in California and the United States 

THE UC REPORT DRAWS FOUR BASIC CONCLUSIONS ABOUT THE IMPLICATIONS OF REACH

FOR CALIFORNIA. 

First, the report presents evidence suggesting that REACH will improve the technical and commercial viability of green chemistry by improving accountability and 

oversight in the chemicals market. Second, the report notes that REACH could 

present a unique challenge to California’s small and medium-sized chemical producers, and that California could take steps now to assist these businesses in meeting REACH requirements. Third, the report proposes that REACH could present an 

opportunity for California to gather toxicity and other information on many chemicals in commercial circulation, and that for this information to be most useful, California will need to gather sales data on the distribution of chemicals sold in the 

State. Fourth, the report concludes that while REACH is expected to drive innovation in safer chemicals, it is also conceivable that some producers will seek to market ‘‘non- E.U.-compliant’’ hazardous chemicals in countries where regulatory oversight is weak, such as in the United States, particularly during transitional ‘‘sellthrough’’ periods. 

RESPONSES BY MICHAEL P. WILSON TO ADDITIONAL QUESTIONS

FROM SENATOR JEFFORDS

Question 1. Dr. Wilson, in the ever-expanding global market, will the European 

Union’s REACH initiative alter chemical industry behavior in the United States? If 

so, to what extent? 

Response. It is clear that REACH will affect all U.S. producers of chemicals and 

chemical products that manufacture in, or import into, the E.U. It will also indirectly affect all U.S. companies whose supply chains include chemicals or chemical 

products that are manufactured in the E.U., or that are manufactured in the United 

States and exported into the E.U. It is not possible to predict how REACH will affect ‘‘behavior’’ among U.S. producers of chemicals and chemical products; however, 

some chemical industry observers expect that important changes could occur in the 

chemicals market as REACH is implemented, and others suggest that the political 

climate surrounding chemicals policy in the United States could be affected. These 

potential developments are summarized below. 

Question 2. Dr. Wilson, if hazardous chemicals are banned in the European Union 

but not at home, will the U.S. market for such chemicals expand? 

Response. Thank you for these questions. It is appropriate to open a discussion 

of TSCA and chemicals management in the United States with a question pertaining to the European Union’s proposed Registration, Evaluation, and Authorization of Chemicals initiative, known as REACH. As you know, we were asked by the 

California Legislature in January 2004 to evaluate chemical challenges facing California, and we, too, recognized the importance of REACH for the U.S. chemical industry and for United States and California chemical management programs. Our 
86 

1The Commission was mandated by the 1990 amendments to the Clean Air Act, comprised 

ten commissioners appointed in a bipartisan manner, and operated between 1994 and 1997. 2U.S. Commission on Risk Assessment and Risk Management (1997). Final Report, Volume 

2. Risk Assessment and Risk Management in Regulatory Decision-A faking. GPO #055-000- 

00567-1. page 128. Available at http://www.riskworld.com/nreports/1996/risk—/ 

rpt:RR6ME001.HTNM 

report, Green Chemistry in California: A Framework for Leadership in Chemicals 

Policy and Innovation, which the UC Office of the President released to the Legislature on March 14, 2006, discusses REACH at some length. I will refer you in some 

questions to responses I prepared for Senator Inhofe, above, which describe issues 

related REACH. 

A. REACH WILL INTRODUCE A NEW LEVEL OF ACCOUNTABILITY FOR CHEMICAL

PRODUCERS WITH OPERATIONS IN THE E.U. 

Over a period of 11 years, REACH will introduce new responsibilities and a greater degree of Government oversight for U.S. producers of chemicals and chemical 

products (that manufacture in, or import into, the E.U.). Generally speaking, producers will be responsible for disclosing more information about the health and safety of the chemicals they produce (particularly for chemicals sold in larger volumes); 

they will be required to distribute this information into supply chains to end users; 

and they will be required to gather information from end users to determine how 

chemicals are being used. REACH will gradually remove the distinction between 

chemicals already on the market (so-called ‘‘existing’’ chemicals) and ‘‘new’’ chemicals. Producers will need to seek Government approval for certain chemicals on a 

use-by-use basis. These so-called ‘‘chemicals of very high concern’’ will be presumptively removed from commercial circulation unless the producer can demonstrate 

that the production and use of these chemicals can take place under adequately controlled conditions, or if this is not the case, that their ‘‘socio-economic benefits outweigh the risk to human health or the environment. . . and if there are no suitable alternatives.’ These measures represent a degree of responsibility and oversight 

that is new in the global chemical production system, including that of the U.S. This 

will engender a new level of accountability in some sectors of the global chemicals 

market, including that of the U.S. 

STATEMENT OF GAIL CHARNLEY, PH.D., PRESIDENT, HEALTHRISK STRATEGIES

Since the early 1990s, our awareness and understanding of the special 

susceptibilities of children to chemical exposures has improved substantially. Our 

precautionary methods for setting limits on chemical exposures take children’s 

unique exposure characteristics into account and provide margins of safety that protect children when greater susceptibility to toxicity is known or suspected. A variety 

of voluntary programs have been initiated under the umbrella of TSCA that have 

generated basic toxicity data for most of the chemicals in commerce by volume, including information about children’s exposures and susceptibilities. These efforts 

will continue to produce data and chemical-specific exposure limits will continue to 

be generated and fine-tuned as new data on developmental toxicity become available. Meanwhile, to the extent they are available, environmental and biomonitoring 

data demonstrate that chemical emissions and body burdens continue to decline. 

TSCA PROGRESS

In its 1997 final report, the Presidential/Congressional Commission on Risk Assessment and Risk Management1 (for which I served as executive director) evaluated and made recommendations regarding the risk assessment and risk management policies and practices across the Federal Government. With regard to TSCA, 

the Risk Commission concluded: 

Given the divergent views about the situation, the history of litigation, the advances in the world of testing and toxicologic interpretation, and the willingness of 

all parties to engage in dialogue, the Commission recommends that EPA, industry, 

academia, and worker, consumer, and environmental organizations be convened in 

a sustained stakeholder process to review TSCA and its implementation, to propose 

criteria for developing test batteries, to seek consensus on making weight-of-evidence judgments about such data. [and] to define criteria for making data more accessible to the public.2

Since the time of the Commission’s report, a variety of activities has taken place 

that is consistent with that recommendation. Among the prominent ones are: 
87 

3For a status report, see Williams PRD, Patterson J, Briggs DW (2006). VCCEP: Progress on 

evaluating children’s risks and data needs. Risk Analysis 26:781-801 4U.S. EPA/Environmental Protection Agency (2001). The National Children’s Study. Conducted in partnership with the U.S. Department of Health and Human Services. Available at 

http://www.nationalchildrensstudy.gov/ 

• U.S. EPA convened the National Pollution Prevention and Toxics Advisory Committee, a national advisory body that provides advice. information. and recommendations on the overall policy and operation of programs managed by the Office of Pollution Prevention and Toxics in performing its duties and responsibilities 

under TSCA. The Committee provides a forum for public discussion and the development of independent advice to the EPA Administrator by taking advantage of the 

experience, strengths and responsibilities of a broad range of Agency constituents 

and stakeholders. • The l High Production Volume (HPV) Challenge Program was launched in 1998 

as a cooperative effort among EPA. the American Chemistry Council, and Environmental Defense. More than 300 companies and consortia volunteered for the program, providing safety information on nearly 95 percent of U.S. chemical production 

by volume. The HPV program is a tiered testing program that generates a basic set 

of toxicity data first on key end points, including reproductive, developmental, systemic, and genetic toxicity. The results of the basic testing allow scientists to evaluate potential hazards and decide whether additional toxicity tests are needed and, 

if so, which specific tests would be appropriate. This tiered testing and evaluation 

framework promotes an efficient use of resources, including laboratory animals, by 

targeting substances posing the greatest potential hazards. The HPV Challenge Program is nearly complete and has greatly accelerated the public availability of hazard 

screening data and critical information used to evaluate the potential health and environmental effects of HPV chemicals. The HPV program is now supplemented by 

the Extended High Production Volume Program, a voluntary, industry-led initiative 

that continues to generate toxicity screening data for newer HPV chemicals and to 

make those data publicly available. • The Voluntary Children’s Chemical Evaluation Program is a voluntary pilot 

program that is part of EPA’s Chemical Right-to-Know Initiative. The goal of the 

pilot is to better understand potential health risks to children associated with certain chemical exposures. The key question of the program is whether the potential 

hazards, exposures, and risks to children have been adequately characterized and, 

if not, what additional data are necessary. EPA has asked companies that manufacture or import 23 chemicals found in human tissues and the environment to volunteer to sponsor chemical evaluations. Sponsorship requires the companies to collect 

or develop health effects and exposure information on their chemicals and then to 

integrate that information in a risk assessment and a data needs assessment. Like 

the HPV program, VCCEP uses a tiered testing scheme to generate a basic set of 

toxicity and exposure data and then uses the results to determine what types of further testing is needed. The results of the pilot program thus far illustrate how various parties can work together under a voluntary program and how toxicity and exposure data can be integrated to make decisions regarding the adequacy of risk information for children. The program has been in operation since 2002 and is currently being reviewed and fine-tuned.3

These programs demonstrate that voluntary, multi-stakeholder initiatives have 

been initiated and are succeeding under the umbrella of TSCA. Since the mid-1990s, 

basic toxicity data have been generated for most of the chemicals in commerce by 

volume and research efforts have provided information about children’s exposures 

and susceptibilities that has been incorporated into risk assessment and chemical 

standard-setting. These efforts will continue to generate data that will contribute 

to better and better chemical regulation and to safer, healthier children. 

BIOMONITORING AND THE ROLE OF THE ENVIRONMENT IN CHILDREN’S HEALTH

Establishing a role for chemicals in public health in general or children’s health 

in particular is complicated by the fact that ‘‘environment’’ includes many more complexities than just chemical contaminants, such as physical safety, nutrition, socioeconomic factors, infectious agents, naturally occurring substances, ultraviolet radiation, tobacco smoke, and natural disasters. The National Children’s Study defines 

a child’s environment broadly, including natural and man-made environment factors, biological and chemical factors, physical surroundings, social factors, behavioral influences and outcomes, genetics, cultural and family influences and differences, and geographic locations.4 Notable among the varying definitions of environment and the various attempts to quantify environmentally attributable proportions of disease is the comparatively small role that chemical exposures evidently 
88 

5Smith KR, Corvalan CF, Kjellstrom T (1999). How much global ill health is attributable to 

environmental factors? Epidemiology 10:573-84 6EPA Environmental Protection Agency (2003). Draft Report on the Environment 2003. Technical Document. EPA-600-R-03-050. Office of Research and Development and Office of Environmental Information. Washington. DC. Available at http://www.epa.gov/indicators/roe/index.htm 7National Academy of Sciences/National Research Council (2006). Human Biomonitoring for 

Environmental Chemicals. National Academy Press. Washington, DC. Page 2 8Centers for Disease Control and Prevention (2005). National Report on Human Exposure to 

Environmental Chemicals. Third Report. Atlanta, GA. Available at http://www.cdc.gov/ 

exposurereport/ 

play against the backdrop of socioeconomic conditions, behavioral factors, psychological factors, infectious agents, nutrition, and other considerations. 

Several studies have attempted to evaluate the role of environment in ill health. 

For example, one evaluation estimated the extent to which global ill health is attributable to environmental risk factors, excluding genetics, diet, smoking, and some 

component of injuries but including food additives, infectious agents, pesticides, passive smoking, behavioral factors related to personal and household hygiene, some 

malnutrition, and the natural environment (e.g., dust and natural disasters).5 That 

study concluded that 12 percent of disease in established market economies is potentially attributable to environmental factors. Compared to all ages, the proportions of children’s environmentally attributable disease burden is about 0.8 percent. 

This is not to say that chemical exposures do not play a role or that their contribution should be ignored; even if their contribution is small, it could constitute 

a public health problem by virtue of the numbers of people affected. However, given 

their relatively small contribution, chemical contaminants should not be treated in 

isolation from other factors if an effective environmental strategy for protecting. and 

improving public health—and especially children’s health—is desired. 

Attributing specific health outcomes to specific chemicals at environmentally relevant levels of exposure is, except in the rarest of cases, unlikely to be either possible or defensible. For example, while the cause of childhood asthma may be traced 

to genetic influences, its occurrence may be triggered by environmental tobacco 

smoke or urban air pollution. An environmental health strategy that targets specific 

exposures without considering the contributions of other risk factors and the multi 

factorial etiology of disease will not be effective. In any case, dissecting out the contributions of genetics and economic, social. cultural. behavioral, and psychological 

factors for the purpose of identifying and reducing environmental risks in general, 

or chemical risks in particular, is unlikely to be straightforward. As EPA put it recently:6

One of the greatest challenges to elucidating the connection between environmental exposure and disease is the fact that exposure to an environmental pollutant 

or stressor is rarely the sole cause of an adverse health outcome . . . Other factors 

include, for example, diet, exercise, alcohol consumption, heredity. medications. and 

whether other diseases are present. . . Also, different people have different 

vulnerabilities. . . All these factors make it difficult to establish a causal relationship between exposure to environmental pollutants and disease outcome. . .

For the reasons discussed above, biomonitoring data that provide information 

solely about trace levels of chemicals in blood or urine at a single point in time cannot be used to draw conclusions about the likelihood of disease except in very rare 

cases. Biomonitoring data can be used to demonstrate trends in exposure over time, 

to establish that exposure has occurred, to identify individuals with unusual exposures, or to help clarify the relationship between exposure and dose in some cases, 

but generally do not provide an indication with regard to the likelihood of ill health. 

As the recent National Academy of Sciences report Human Biomonitoring for Environmental Chemicals put it: 

The ability to generate new biomonitoring data often exceeds the ability to evaluate whether and how a chemical measured in an individual or population may cause 

a health risk or to evaluate its sources and pathways of exposure. . . For sonic 

chemicals (such as mercury and lead), the health risks and effects are well known; 

but for most of the chemicals currently measured, the risks cannot be interpreted.7

As the Centers for Disease Control and Prevention puts it in its National Report 

on Human Exposure to Enviroinnonal Chemicals: 

The presence of a chemical in a blood or urine specimen does not mean that the 

chemical causes a health risk or disease.8

Our analytic abilities increasingly permit the detection of substances in biological 

samples in smaller and smaller trace quantities. That does not mean we are increasingly at risk of chemical-related disease. Trace levels of chemicals in the body are 

unlikely to overwhelm the body’s natural ability to detoxify and eliminate them. 
89 

9See for example, EPA (2000). National Pollutant Emission Trends, 1900-1998. EPA-454/R-00- 

002. Office of Air Quality Planning and Standards. Research Triangle Park, NC. Available at 

http://www.epa.gov/ttn/chief/trends/trends98/trends98.pdf 10Euro Chlor (2003). Dioxins and Fw’ans in the Environment. Science Dossier. Bnissels, 

Beleium. Available at www.eurochlor.org 11Aylward LL, Hayes SM (2002). Temporal trends in human TCDD body burden: Decreases 

over three decades and implications for exposure levels. Journal of Exposure Analysis and Environmental Epidemiology 12:319-328 12Lorber M (2002). A phannacokinetic model for estimating exposure of Americans to dioxinlike compounds in the past. present, and future. The Science of the Total Environment 288:81- 

95 13LaKind JS, Berlin C. Naiman DQ (2001). Infant exposure to chemicals in breast milk in 

the United States: What we need to learn from a breast milk monitoring program. Environmental I Health Perspectives 109:75-88 14La Leche International (1994). Pesticides and breast feeding. LEAVEN 30:37-40 15American Academy of Pediatrics (1997). Policy statement on breast feeding and the use of 

human milk. Pediatrics 100:1035-1039 16European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) 2005. Trends in 

Children’s Health and the Role of Chemicals: A State of the Science Review. Brussels. 

Given our incomplete knowledge of the inter-relationships among multiple chemical 

and non-chemical, environmental and non- environmental stressors, interpretation 

of the potential impact of exposure to trace levels of chemicals, if any, will probably 

be dependent on eventual decoding of the human genome map. Meanwhile, using 

laboratory animals to provide information on chemical toxicity can help us identify 

target organ systems and target risk management strategies. but is unlikely to provide insight with regard to the potential impact of trace levels of chemicals. 

The good news is that, to the extent that they exist, environmental and biomonitoring trend data demonstrate that emissions and body burdens of contaminants 

continue to decline. EPA emissions data show that pollutant levels have generally 

declined while our economy has grown.9 For example. dioxin and furan concentrations in the environment and human tissues have been declining since the 1970s. 

Samples taken of sediments from remote lakes impacted purely by atmospheric deposition and transport and of archived soils and herbage show low background levels 

of naturally occurring dioxins and furans prior to 1900 followed by a sharp rise after 

1930, coinciding with the onset of industrialization and the large-scale production 

and use of organochlorine compounds, peaking in the 1970s, with a slow decline 

until the present day. Evidence for this decline has also been found in studies on 

archived sewage sludge, air measurements, and biological samples.10 Human tissue 

concentrations of 2,3,7,8-TCDD taken from residents of Germany, France, the 

United States, and Canada show that exposure has declined by more than 95 percent since 1972.11 Other data show that if exposure to dioxin-like compounds stays 

at present levels (which is unlikely), current body burdens will fall by more than 

50 percent by 2020.12

Studies show that the levels of contaminants in breast milk are also declining. 

For example. data from Germany, Norway, and the Netherlands indicate that concentrations of dioxins and brains have decreased by at least 50 percent since 1980.13

Other substances for which trend data are available show continued declines as 

well. The extent to which chemicals present in breast milk present a health risk 

to the breast feeding infant is not known. Virtually all national and international 

expert committees have concluded that, on the basis of available information, the 

benefits of breast feeding outweigh the possible risks from chemical contaminants 

present in human milk at normal levels.14 In fact, epidemiologic research shows 

that human milk and breastfeeding of infants provide advantages with regard to 

general health, growth, and development, while significantly decreasing risk for a 

large number of acute and chronic diseases.15

An expert committee was convened by the European Centre for Ecotoxicology and 

Toxicology of Chemicals to review trends over time in chemical exposures and in 

children’s health.16 That committee drew a number of conclusions that are germane 

to evaluating the role of chemical exposures and children’s health: • In comparing time trends of disease improved reporting systems, changes in diagnostic criteria/procedures, a more active approach to early detection of cases to 

improve prognosis and a better health care system in general must be taken into 

account. There is clear evidence of increasing rates of asthma in children, although 

rates in some countries may now have stabilized. There is no convincing evidence 

of widespread trends in other acute or chronic childhood respiratory diseases. Indoor 

air quality appears to be related to both asthma and, in some cases, to other respiratory-related diseases (such as otitis media). Interpretation of the available information on asthma and allergies is made difficult by inconsistent application of diagnostic criteria over place and time. Contemporaneous with the increasing frequency 
90 

17New York Times, Sunday July 30, 2006 

of asthma, data also suggest that other atopic disorders such as upper respiratory 

and food allergy may be increasing. Atopic dermatitis remains the leading skin disorder in young children. 

• Although the frequency of neurodevelopmental disorders such as autism and attention deficit disorder is commonly believed by the public to be increasing, the limited data available do not support this perception. 

• Data on reproductive effects are also limited and often suffer from serious data 

quality issues. Whilst geographic heterogeneity is apparent, broad population trends 

for these outcomes (sperm quality, hypospadias, cryptorchidism) are difficult to identify except for decreasing age at puberty in females. 

• There is no evidence for major trends in the frequency of childhood cancer. Data 

indicate that developed countries tend to have a gradually increasing incidence of 

leukaemia with a corresponding drop in the incidence of lymphoma. Increases in 

brain tumour frequency are possibly related to the development of new diagnostic 

capabilities rather than to a true change in the incidence in the rate of malignant 

disease. With the increasing number of childhood cancer survivors, secondary cancers following chemotherapy appear to be on the increase. 

• A wide range of environmental factors is thought to have an impact on children’s health, extending well beyond industrial chemicals. These factors include nutrition (protein, vitamins, anti-oxidants), lifestyle and behavior choices such as tobacco and alcohol use, parental health, socio-economic status, choice of living environment (urban vs. rural, etc.), and parent-sibling behavior. From the available 

data, no general conclusions on the contribution of specific chemicals can be drawn 

across the multiple health outcomes addressed in [the committee’s] report. 

It is illogical to presume that any chemical exposure is dangerous and that any 

potential chemical hazard poses a risk. And, even if they were occurring, increases 

in childhood health problems would be unlikely to be associated with environmental 

contaminant concentrations that are decreasing. Even the New York Times notes 

that people alive today in developed countries are healthier than they used to be, 

live longer, get heart disease and other chronic illnesses later in life than they used 

to, experience less disability, and have higher IQs.17 Much of those improvements 

is due not just to better medical care but also to better nutrition, higher birth 

weights, and fewer hazardous occupational and environmental exposures. 

LIMITING CHEMICAL EXPOSURES

Current EPA methods for setting standards to limit chemical exposures are precautionary and account for the possibility that children can be more susceptible 

than adults to chemical toxicity. When information on developmental toxicity is 

available, it is considered. When developmental toxicity is the most sensitive end 

point of toxicity, it serves as the basis for standard-setting. When no information 

on developmental toxicity is available, a database uncertainty factor is used to make 

the standard more stringent than it would be otherwise, in order to be precautionary and account for the possibility that children might be more susceptible 

than adults. 

Traditionally, chemical risk assessment has been performed by comparing a measured or estimated human dose to a dose associated with a toxicity endpoint, such 

as a no-observedadverse-effect level (NOAEL) or a benchmark dose, after adjustment by adequate uncertainty and/or safety factors. Adjusting for uncertainty generally involves dividing a NOAEL or benchmark dose derived from human data by 

10 to yield a level of exposure that would be protective of individuals who might 

be more sensitive than those tested or observed. If no human data are available, 

a NOAEL or benchmark dose identified using laboratory animals is divided by 100- 

10 to protect sensitive individuals (intraspecies factor) and 10 to account for the possibility that humans could be more sensitive than the species tested (interspecies 

factor). The resulting lifetime exposure level is considered likely to be without adverse effects in humans, including sensitive subgroups or life stages, because the 

intraspecies uncertainty factor is meant to protect sensitive groups such as children 

or the elderly. 

A number of scientists have attempted to investigate quantitatively whether the 

intraspecies uncertainty factor is adequate to account for the variability to chemical 

toxicity between the overall human population and its potentially more sensitive 

groups, including children. Dourson et al (2002) reviewed 17 studies that performed 

quantitative analysis of the extent of toxicodynamic and pharmacokinetic variability 

using different data and different starting points, some specifically evaluating age 
91 

18Dourson M, Charnley G, Scheuplein R. 2002. Differential Sensitivity of Children and Adults 

to Chemical Toxicity. II. Risk and Regulation. Regulatory Toxicology and Pharmacology, 35:448- 

467 19Hattis D, Banati P, Goble R. 1999a. Distributions of Individual Susceptibility Among Humans for Toxic Effects. How Much Protection Does the Traditional Tenfold Factor Provide for 

What Fraction of Which Kinds of Chemicals and Effects? Annals of the New York Academy of 

Sciences 895:286-316; Hattis D, Banati P, Goble R, and Burmaster D. 1999b. Human Interindividual Variability in Parameters Related to Health Risks. Risk Analysis 19:705-720; Renwick 

AG and Lazarus NR. 1998. Human variability and noncancer risk assessment an analysis of 

the default uncertainty factor. Reg Toxicol Pharmacol 27:3-20 20Schneider KI, Gerdes H, Hassauer M, Oltmanns J, Schulze J. 2002. BerUcksichtigung der 

Risikogruppe Kind bei der Ableitung gesundheitsbezogener Umweltstandards. UFOPLAN-Nr. 

201 61 215. Forschungs- and Beratungsinstitut Gefahrstoffe GmbH (FoBiG), Freiburg 21U.S. Department of Agriculture (1985). Nationwide Food Consumption Survey: Continuing 

Survey of Food Intakes by Individuals, Women 19-50 Years and Their Children 1-5 Years. 

Human Nutrition Information Service. Washington, DC 22National Academy of Sciences/National Research Council (1993). Pesticides in the Diets of 

Infants and Children. National Academy Press. Washington, DC 

effects in both humans and animals.18 That analysis suggests that a high percentage of the population, including children, is protected by using a 10-fold uncertainty 

factor for human variability. Studies indicating that in some cases the young would 

not be protected by the standard uncertainty factor were those that evaluated acute 

lethality in laboratory animals (LD5os) and are therefore less relevant to evaluating 

risks from environmental exposures. Based on specific comparisons for newborns, infants, children, and adults, the range of the population protected is between 67 and 

100 percent. Studies using larger populations that include sensitive individuals suggest that the value is closer to 100 percent.19

Other evaluations concur with those of Dourson et al (2002). For example, the 

German Research and Advisory Institute for Toxic Chemicals concluded that, based 

on toxicokinetic differences, the most susceptible group of neonates is protected by 

a 10-fold intraspecies uncertainty factor in most cases.20 The authors also conclude, 

however, that the protection of neonates and infants may require consideration of 

their lower xenobiotic clearance rates and recommend using a log-normal density 

function, based on the differences in adult and neo-natal clearance rates, in the 

framework of probabilistic risk assessments. 

Conclusions about the adequacy of the 10-fold intraspecies uncertainty factor do 

not mean that interindividual sensitivity varies 10-fold, as is often thought. Its application to a value in the low end of the distribution of human sensitivities, such 

as a NOAEL, and its use in conjunction with other uncertainty factors and conservative assumptions, actually cover total human sensitivity variations of 100 to 1,000 

times (see Exhibit 4). 

In the absence of important data on a substance’s toxicity, such as reproductive 

or developmental toxicity, standard EPA practice has been to use a ‘‘database uncertainty factor’’ in addition to the other factors. The database uncertainty factor is 

generally a factor of 10 that is added to the calculation of an exposure limit, making 

it ten times more stringent than it would be otherwise. In other words, EPA uses 

an extra uncertainty factor when there is inadequate information about developmental effects, reproductive effects, or developmental neurotoxicity in order to be 

precautionary and health-protective. 

AGE AND CHEMICAL EXPOSURES

Children’s exposures to chemicals from their environment are qualitatively and 

quantitatively different from those of adults. For example, children are likely to be 

exposed to different levels of chemical contaminants in foods than adults because 

they consume more calories of food per unit of body weight, fewer types of foods, 

and more processed foods.21 The National Academy of Sciences report Pesticides in 

the Diets of Infants and Children22 concluded that differences in diet and thus in 

dietary exposure to pesticide residues account for most of the potential differences 

in pesticide-related health risks that may exist between children and adults. 

Normal childhood behaviors such as hand-to-mouth activity and crawling on the 

floor or ground can increase children’s exposures to potential toxicants through ingestion and contact with dusts and residues. Greater risk of lead poisoning from 

lead-based paint is a well-known example of that problem. Children breathe more 

than adults on a body-weight basis, so may be exposed to higher doses of air pollutants. Children consume more water than adults on a body-weight basis, so may be 

exposed to higher doses of water pollutants. Infants consume breast milk, an important source of nutrition and immunologic protection, but sometimes a source of fatsoluble contaminants such as PCBs. Children may not perceive hazards as quickly 
92 

23Wilson J (1977) Current Status of Teratology; General Principles and Mechanisms Derived 

from Animal Studies. In: Handbook of Teratology; General Principles and Etiology, ed. J Wilson 

and F Fraser. New York: Plenum Press; Faustman EM, Silbernagel SM, Fenske RA, Burbacher 

TM, Ponce RA (2000). Mechanisms underlying children’s susceptibility to environmental toxicants. Environmental Health Perspectives 108:13- 21 24Penna A, Buchanan N (1991). Paracetamol poisoning in children and hepatotoxicity. British 

Journal of Clinical Pharmacology 32:143-149 25Renwick AG (1998). Toxicokinetics in infants and children in relation to the ADI and TDI. 

Food Additives and Contaminants 15S:17-35 26Public Health Policy Advisory Board (1999). Health and the American Child. Part I: A Focus 

on Mortality Among Children. Risks, Trends, and Priorities for the Twenty-First Century. Washington, DC 

or effectively as adults, so may experience some greater exposures by not avoiding 

them as readily. In contrast, adults have higher exposures than children to chemicals associated with activities such as home car repair, cleaning, home painting, and 

other recreational or maintenance activities. Occupational exposures also would be 

greater for adults than children, although there are situations, such as pesticide application, where parents’ exposures result in children’s exposures when applicators 

return home after working. 

Exposure is not the only determinant of toxicity, however. Once exposure has occurred, age-related differences in the body’s ability to absorb, distribute, metabolize, 

and eliminate chemicals can produce different doses from the same exposures. Risks 

to health are determined by exposure, dose, and susceptibility. Even if children’s exposures or doses of substances exceed those of adults on a body-weight basis, they 

will still not be at risk unless the doses are high enough to produce toxicity. The 

dose or level of exposure that is capable of producing toxicity is determined by children’s inherent susceptibility, which may be greater than adults in some cases and 

less in others. 

AGE AND SUSCEPTIBILITY

There are many physiologic and pharmacologic reasons why the susceptibility of 

children and adults to the impacts of chemical exposures may differ. The developing 

organism experiences many complex, integrated events involving the regulation of 

cell growth, differentiation, and morphogenesis. Interfering with those events 

through mutation or through altered cell division, enzyme function, or energy 

sources can have significant adverse impacts on development.23 Many environmental factors can have an impact on normal development, including nutrition and 

folic acid availability, maternal smoking and alcohol consumption, prescription 

drugs, and chemical contaminants such as lead and organic mercury. 

Children are more sensitive than adults to the toxic effects of many chemicals, 

such as lead. At the same time, children are often less sensitive to many chemicals 

than are adults. For example, unlike the situation in adults, liver toxicity and death 

from acetaminophen poisoning is extremely rare in children24 The metabolism and 

elimination rates of many drugs and other substances are known to be higher in 

children than adults. As a result, children will often have lower body burdens of 

drugs or chemicals than adults for the same exposures, when expressed on a bodyweight basis. For example, as Exhibit 1 shows, morphine is cleared about 2-3 times 

faster by children than by adults. The chemotherapy drug methotrexate is cleared 

six times faster by children than by adults. The antipsychotic drug Thorazine is 

cleared five times faster by children than by adults. As a result, kids require higher 

pharmacologic doses than adults of those drugs to achieve efficacy. 

Thus, while some chemicals may be metabolized to toxic metabolites more quickly 

by children, those metabolites are likely also to be deactivated and eliminated more 

rapidly, presumably becoming less toxic by decreasing their effective doses. Children’s generally more rapid elimination rates may compensate in part for any increased sensitivity during development.25 A number of environmental exposures, including pesticides, parental occupational exposures, and infectious organisms have 

been suggested as possible precursors to cancer or other health effects in children; 

however, the considerable research conducted to date has yielded inconsistent or 

limited evidence identifying those factors as disproportionate threats to children’s 

health.26

Rodent bioassays show that younger animals are less susceptible to chemical carcinogens in some cases and more susceptible in others. Pesticides in the Diets of 

Infants and Children included a table summarizing the results of studies that had 

been performed through 1983 in which the effects of age on chemically induced car-
93 

27Charnley G, Putzrath RM (2001). Children’s health, susceptibility, and regulatory approaches to reducing risks from chemical carcinogens. Environmental Health Perspectives 

109:187-192 28Calabrese EJ (1986). Age and Susceptibility to Toxic Substances. New York: John Wiley & 

Sons 29Bruckner JV (2000). Differences in sensitivity of children and adults to chemical toxicity: 

the NAS panel report. Regulatory Toxicology and Pharmacology 31:280-285 30Gaines TB, Linder RE (1986). Acute toxicity of pesticides in adult and weanling rats. Fundamental and Applied Toxicology 7:299-308 31Brodeur J, DuBois KP (1963). Comparison of acute toxicity of anticholinesterase insecticides 

to weanling and adult male rats. Proceedings of the Society for Experimental Biology and Medicine 114:509-511 32Davidson EH, Rast JP, Oliveri P, Ransick A, Calestani C, Yuh CH, Minokawa T, Amore 

G, Hinman V, Arenas- Mena C, Otim 0, Brown CT, Livi CB, Lee PY, Revilla R, Rust AG, Pan 

Z, Schilstra MJ, Clarke PJ, Arnone MI, Rowen L, Cameron RA, McClay DR, Hood L, Bolouri 

H (2002). A genomic regulatory network for development. Science 295:1669-1678 

cinogenesis in rodents had been evaluated. That list was updated in 2001.27 As can 

be seen in Exhibit 2, the data indicate that there are a similar number of studies 

showing that younger animals are less susceptible than adults to chemically induced 

carcinogenesis as there are showing that they are more susceptible under the conditions of the bioassays. A number of studies showed that age played no role at all 

in susceptibility. 

The National Academy of Sciences report concluded that those results clearly 

demonstrate that age may be an important factor in susceptibility to chemically induced carcinogenesis, but they do not support the conclusion that younger animals 

are always more susceptible than older animals. The database also illustrates the 

difficulty associated with assessing quantitatively the extent of the differences in 

susceptibility due to age. Virtually all of the studies evaluated used only one dose 

level, so the underlying dose-response relationships are unknown and comparison of 

sensitivities is possible only at the relatively high, single dose levels used. Generalizations about the effect of age on susceptibility to chemical carcinogens are thus 

difficult to make. 

Data on acute chemical toxicity show similar results. Exhibit 3 shows how the lethal dose of DDT varies with age, indicating that in this case, infant rats are much 

less susceptible to toxicity than adult rats. A review by Ed Calabrese of the data 

available on LD50s showed only small differences due to age. In some cases, young 

animals were more susceptible and, in some cases, adult animals were more susceptible.28 In only a few cases did the differences exceed an order of magnitude, however, and in many cases, there were no differences. Data on the maximum tolerated 

doses of chemotherapeutic agents in humans show that they were frequently higher 

for children than adults, indicating greater susceptibility of adults, although the differences between age groups were usually less than or equal to two.29 Studies of 

pesticide acute toxicity also show variability. In one study, no more than 2- to 3- 

fold differences in sensitivity were observed, with the younger animals more sensitive to toxicity than older animals in only four out of 36 cases.30 In another study, 

however, 14 of 15 organophosphate pesticides showed greater acute toxicity to young 

rats than to adult rats.31

Chemical exposures can affect normal prenatal or childhood development by interfering—either directly or indirectly—with the large network of regulatory genes that 

control growth and development. In contrast to physiological responses, which can 

vary in response to exposures or other stimuli and then return to normal, developmental systems move inexorably forward. 

Perturbation of critical components of the regulatory gene network can have two 

possible outcomes. The consequences of interference may not be repaired as development moves forward or the complexity of the system may confer the ability to compensate for perturbations, should they occur, illustrating again the difficulty of making generalizations about age and susceptibility.32

What the scientific evidence on age-related susceptibility to the effects of chemical 

contaminants does show is that children may be more than, less than, or just as 

sensitive as adults, depending on the chemical and the exposure situation. Children 

may be less sensitive to the effects of a chemical than adults if they do not absorb 

it as readily, if they clear it more rapidly, if they lack the enzymes required to activate it, if they detoxify it more quickly, or if they compensate more readily for any 

damage. Most of the available information on age-related differences in sensitivity 

comes from experiments using single, high doses of chemicals that produced shortterm, acute toxicity, however. Those observations may be poor predictors of what occurs when low doses of chemicals are received over long periods of time or of developmental toxicity. Long-term exposure to low doses of chemicals can produce dif-
94 

33Scheuplein R, Chamley G, Dourson M (2002). Differential sensitivity of children and adults 

to chemical toxicity. I. Biological basis. Regulatory Toxicology and Pharmacology 35:429-447 34Mattson JL, Maurissen PJ, Nolan RJ, Baal( KA (2000). Lack of differential sensitivity to 

cholinesterase inhibition in fetuses and neonate compared to dams treated perinatally with 

chlorpyrifos. Toxicological Sciences 53:438-446 35Wargo J (1996). Our Children’s Toxic Legacy. New Haven: Yale University Press 

ferent types of toxicity than short-term exposure to high doses. On the other hand, 

low environmental exposures to chemicals are less likely to overwhelm developing 

detoxification and other defense mechanisms, so age-related differences at low doses 

may be quantitatively less pronounced than at high doses.33 For example, data for 

the insecticide chlorpyrifos show that young animals are more sensitive than adults 

to its nervous system toxicity at high doses, but are less or similarly sensitive than 

adults at low doses.34 The reason for the difference in this case is that young animals can compensate for toxicity faster than adult animals can at lower doses by 

synthesizing replacement cholinesterase faster, but cannot compensate for it fast 

enough at higher doses. 

The effect of age on susceptibility to chemical toxicity appears to depend on the 

chemical of concern, the toxic effect that is observed, the dose that is received, and 

the period of development during which exposure occurred, with infants, children, 

or the developing fetus more sensitive than adults in many cases but less sensitive 

in others. Susceptibility to chemical toxicity is the result of extremely complex biological interactions and there is no systematic method or model to predict age-related susceptibility.35 There is no scientific support for any statement implying that 

children are always more sensitive than adults to environmental chemical exposures. 

RESPONSES BY GAIL CHARNLEY TO ADDITIONAL QUESTIONS

FROM SENATOR INHOFE

Question 1. Dr. Charnley, it has been suggested that children are more highly exposed to industrial chemicals and thus they are a more vulnerable subpopulation 

that TSCA needs to categorically protect. Scientifically, can it be assumed that children have higher exposure in all cases and can it be assumed that the children are 

always more vulnerable than adults to chemicals to which they are exposed? 

Response. Children are more highly exposed to chemicals than adults in many 

cases, although not always. For example, children are likely to be exposed to different levels of chemical contaminants in foods than adults because they consume 

more calories of food per unit of body- weight, fewer types of foods, and more processed foods. Children’s chemical exposures and metabolic profiles can be qualitatively and quantitatively different from those of adults, so they may experience 

higher or lower doses on a body-weight basis for the same exposure levels. When 

possible, chemical risk assessments should include consideration of different exposure characteristics for children and any other groups of people or particular life 

stages that might be more or less exposed than average. Children can be more sensitive to a certain chemical toxicity than adults because they may be more vulnerable to external challenges during critical stages of the developmental process. In 

other cases, they can be less sensitive to chemical toxicity than adults due to more 

efficient elimination processes, less mature activating enzymes, and enhanced ability to repair damage. The intrinsic relative susceptibility of children depends on the 

specific physical, toxicological, and metabolic characteristics of the particular chemical at issue and on the exposure situation of concern. Broadly based statements indicating that children are generally more sensitive to chemical insults are not supported by existing scientific data. And, even if they were occurring, increases in 

childhood health problems would be unlikely to be associated with environmental 

contaminant concentrations that are decreasing. In developed countries, people are 

healthier than they used to be, live longer, get heart disease and other chronic illnesses later in life than they used to, experience less disability, and have higher 

IQs. Those improvements are due not just to better medical care but also to better 

nutrition, higher birth weights, and fewer hazardous occupational and environmental exposures. There is no evidence for a relationship between the U.S. infant 

mortality rate and exposure to chemicals from the environment. 

Question 2. Dr. Charnley, many allege that TSCA does nothing to protect children’s health. How do TSCA and the various programs in OPPTS address children’s 

health issues? 

Response. Several voluntary, multistakeholder programs evaluating children’s 

health as related to chemical exposures have been successfully initiated and con-
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ducted under the umbrella of TSCA. For example, the High Production Volume testing program has generated a basic set of toxicity data on key end points, including 

reproductive, developmental, systemic, and genetic toxicity. The results of the basic 

testing allow scientists to evaluate potential hazards and decide whether additional 

toxicity tests are needed and, if so, which specific tests would be appropriate. In 

other words, if initial chemical testing indicates that a threat to children is possible, 

further testing focuses on that possibility. Another program, the Voluntary Children’s Chemical Evaluation Program is a voluntary pilot program that is part of 

EPA’s Chemical Right-to-Know Initiative. The goal of the pilot is to better understand potential health risks to children associated with certain chemical exposures. 

The key question of the program is whether the potential hazards, exposures, and 

risks to children have been adequately characterized and, if not, what additional 

data are necessary. The results of the pilot program thus far illustrate how various 

parties can work together under a voluntary program and how toxicity and exposure 

data can be integrated to make decisions regarding the adequacy of risk information 

for children. Finally, EPA’s pesticides program includes explicit consideration of 

children’s potentially greater exposures and sensitivities. Pesticide sponsors must 

provide data indicating that children are not at increased risk compared to adults 

if they do not wish to have their product regulated more stringently than it would 

be if children are at greater risk or if no data on children’s potential risks are available. 

Question 3. Dr. Charnley, you mentioned some groups for whom you do work. Can 

you elaborate on your work for industry, non-profits and trade organizations? 

Response. I work only part-time. I spend more than half of the time that I work 

working pro bono for organizations such as the National Academy of Sciences, the 

Environmental Literacy Council, the National Toxicology Program, the Society for 

Risk Analysis, and the Environmental Law Institute. When I get paid for work, my 

clients have been generally a mix of nonprofits (e.g., American Council on Science 

and Health, Ranchers-Cattlemen Action Legal Fund, Public Health Policy Advisory 

Board), Government (e.g., U.S. Environmental Protection Agency, U.S. Agency for 

International Development, Agency for Toxic Substances and Disease Registry, 

State of California), industry associations (e.g., American Chemistry Council, 

CropLife America), companies (e.g., Bayer CropScience, 3M, United States Borax), 

and law firms (e.g., Crowell & Moring, Schiff Hardin, Kirkland & Ellis). I have also 

done some teaching at Yale, Harvard, Georgetown, and George Mason. An elaboration of the kinds of work I have conducted can be found on my website, 

www.healthriskstrategies.com. 

RESPONSES BY GAIL CHARNLEY TO ADDITIONAL QUESTIONS

FROM SENATOR JEFFORDS

Question 1. Dr. Charnley, you mention in your testimony that there are several 

voluntary initiatives, including the HPV Challenge Program that are succeeding 

under the umbrella of TSCA. However, I understand that problems exist in this program such as companies not volunteering to provide data on all HPV program 

chemicals and EPA has no mechanism for placing these chemicals on the HPV list 

once they are produced in greater volume. How would you remedy these problems? 

Response. It is true that some companies did not volunteer to sponsor chemicals 

in the HPV Challenge Program. Those chemicals not sponsored in the program are 

called ‘‘orphans.’’ 

However, TSCA does provide a mechanism through which EPA can obtain health 

and environmental information from those companies. Sections 8(a) and 8(d) of 

TSCA enable EPA to order companies that make or import those orphan chemicals 

to provide production information and unpublished health and safety studies. In 

fact, EPA issued section 8(a) and 8(d) rules on August 16, 2006, covering 243 HPV 

Challenge orphan chemicals. These rules are among EPA’s Office of Pollution Prevention and Toxics largest rulemakings in terms of the number of chemicals covered. Companies affected by these rules must submit this health and environmental 

information to EPA no later than November 14, 2006. 

Additionally, under TSCA’s Inventory Update Rule (IUR), as amended in 2003, 

companies that manufacture or import chemicals are required to report information 

periodically (e.g., the types of chemicals, the amounts manufactured or imported, 

certain details about their manufacture, and other data) to EPA. Any chemical substances produced or imported in quantities of one million pounds or more annually 

are automatically considered HPV. In 2005, at the conclusion of the HPV Challenge 

Program, the chemical industry extended its HPV commitment by launching the Extended HPV (EHPV) Program. Through the EHPV Program, industry has com-
96 

mitted to sponsor chemicals that were not HPV in the original HPV Challenge Program, but were reported as HPV in the 1998 and 2002 IUR. Chemicals that are not 

voluntarily sponsored in the EHPV will become ‘‘orphans’’ and may be subject to another 8(a) and 8(d) final rule by EPA in the future, demonstrating that TSCA can 

be both effective and flexible. 

RESPONSES BY GAIL CHARNLEY TO ADDITIONAL QUESTIONS

FROM SENATOR BOXER

Question 1. Provide a list of all of your clients, including their corporate or individual names, and whether they are a not-for-profit organization. 

Response. Please refer to my response to Senator Inhofe’s question No. 3. 

Question 2. Provide a description of the general nature of your work for your clients, including whether you have promoted initiatives to limit the application of 

Government regulation. Please do not limit your answers merely to work on advisory committees or boards of directors. 

Response. Please refer to my response to Senator Inhofe’s question No. 3. 

Question 3. Please confirm that the Environmental Law Institute is not a paying 

client of yours. 

Response. Please refer to my response to Senator Inhofe’s question No. 3. 
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