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S. HRG. 110–1248 

OVERSIGHT ON EPA 

TOXIC CHEMICAL POLICIES 

HEARING 

BEFORE THE

COMMITTEE ON 

ENVIRONMENT AND PUBLIC WORKS 

UNITED STATES SENATE 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

APRIL 29, 2008 

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

( 

Available via the World Wide Web: http://www.access.gpo.gov/congress.senate 

(II) 

COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

BARBARA BOXER, California, Chairman 

MAX BAUCUS, Montana 

JOSEPH I. LIEBERMAN, Connecticut 

THOMAS R. CARPER, Delaware 

HILLARY RODHAM CLINTON, New York 

FRANK R. LAUTENBERG, New Jersey 

BENJAMIN L. CARDIN, Maryland 

BERNARD SANDERS, Vermont 

AMY KLOBUCHAR, Minnesota 

SHELDON WHITEHOUSE, Rhode Island 

JAMES M. INHOFE, Oklahoma 

JOHN W. WARNER, Virginia 

GEORGE V. VOINOVICH, Ohio 

JOHNNY ISAKSON, Georgia 

DAVID VITTER, Louisiana 

JOHN BARRASSO, Wyoming 

LARRY E. CRAIG, Idaho 

LAMAR ALEXANDER, Tennessee 

CHRISTOPHER S. BOND, Missouri 

BETTINA POIRIER, Majority Staff Director and Chief Counsel 

ANDREW WHEELER, Minority Staff Director 

(III) 

C O N T E N T S 

Page 

APRIL 29, 2008 

OPENING STATEMENTS 

Boxer, Hon. Barbara, U.S. Senator from the State of California ........................ 1 

Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma .................... 3 

Lautenberg, Hon. Frank, U.S. Senator from the State of New Jersey ............... 9 

Hon. John A. Barrasso, U.S. Senator from the State of Wyoming ...................... 10 

Whitehouse, Hon. Sheldon, U.S. Senator from the State of Rhode Island ......... 12 

Craig, Hon. Larry E , U.S. Senator from the State of Idaho ............................... 13 

Cardin, Hon. Benjamin L., U.S. Senator from the State of Maryland ................ 167 

WITNESSES 

Gulliford, Hon. James, Assistant Administrator for Prevention, Pesticides, 

And Toxic Substances, U.S. Environmental Protection Agency ....................... 16 

Prepared statement .......................................................................................... 19 

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

Government Accountability Office ...................................................................... 26 

Prepared statement .......................................................................................... 28 

Giudice, Linda C., M.D., Ph.D., MSc., Professor and Chair, Department of 

Obstetrics, Gynecology and Reproductive Sciences, University of California, 

San Francisco ....................................................................................................... 73 

Prepared statement .......................................................................................... 75 

Responses to additional questions from Senator Boxer ................................ 100 

Gellert, Annette, Co-Founder, Chair, Well Network ............................................ 102 

Prepared statement .......................................................................................... 104 

DeLisi, V.M., President, Fanwood Chemical, Inc. ................................................. 116 

Prepared statement .......................................................................................... 119 

Plunkett, Laura M., Ph.D., DABT, Integrative Biostrategies, LLC .................... 124 

Prepared statement .......................................................................................... 127 

Response to an additional question from Senator Boxer .............................. 150 

Response to an additional question from Senator Inhofe ............................. 150 

Goldman, Lynn R., M.D., M.P.H., Professor, Environmental Health Sciences, 

Johns Hopkins University, Bloomberg School of Public Health ...................... 151 

Prepared statement .......................................................................................... 154 

ADDITIONAL MATERIAL 

Statements 

American Chemistry Council ........................................................................... 169 

Integrative Biostrategies, LLC ........................................................................ 180 

Articles 

Prostate Cancer; David F. Penson, June M. Chan, and the Urologic 

Diseases in America Project ......................................................................... 183 

Testis Cancer; Mitchell H. Sokoloff, Geoffrey F. Joyce, Matthew Wise 

and the Urologic Diseases in America Project ............................................ 252 

Trends in testicular cancer incidene and mortality in 22 European countries: Continuing increases in incidence and declines in mortality .......... 264 

(1) 

OVERSIGHT ON EPA 

TOXIC CHEMICAL POLICIES 

TUESDAY, APRIL 29, 2008 

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

The full committee met, pursuant to notice, at 10 a.m. in room 

406, Dirksen Senate Office Building, Hon. Barbara Boxer (chairman of the full committee) Presiding. 

Present: Senators Boxer, Inhofe, Lautenberg, Klobuchar, 

Whitehouse, Barrasso, Craig 

OPENING STATEMENT OF HON. BARBARA BOXER, 

U.S. SENATOR FROM THE STATE OF CALIFORNIA 

Senator BOXER. The Committee shall come to order. We welcome 

our panel and our honored guests who are here today. 

Today we will hear about the risks that toxic chemicals pose to 

our families and communities. Most at risk are children, pregnant 

women, the elderly and those who are ill. We will also hear some 

disturbing news about the White House and the Bush administration’s efforts to corrupt EPA’s toxic chemical risk assessment process. By placing politics before science, the Bush administration is 

putting the public in harm’s way, this according to the GAO and 

EPA scientists. 

A close look at the EPA’s toxic chemical policies makes clear that 

improvement is necessary if we are to ensure that dangerous 

chemicals are properly regulated. EPA regulates toxic chemicals in 

the environment under several laws. The overall toxic chemicals 

law, the Toxic Substances Control Act, or TSCA, was adopted in 

1976 and was supposed to help assure that toxic chemicals would 

be restricted or banned if they were hazardous. 

But in essence, TSCA puts the burden on the Government to 

prove a toxic chemical is a risk. That is unlike the European program, called REACH. REACH puts the burden on the chemical industry, where it should be, to show that chemicals are safe. 

In implementing TSCA and other laws like the Clean Air Act, 

the Safe Drinking Water Act and Superfund, EPA relies on risk assessments which evaluate how toxic a chemical is and to what extent people are exposed to it. In 1985, EPA developed a system 

called the Integrated Risk Information System, or IRIS, which establishes safe levels for toxic chemicals. The levels set in IRIS are 

used as the scientific foundation for most EPA regulatory programs 

and for many State programs to establish health standards for air 

and water pollution, waste cleanup and other programs. For examVerDate Aug 31 2005 08:38 Aug 12, 2014 Jkt 000000 PO 00000 Frm 00005 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\88900.TXT VERN
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ple, the levels set for arsenic in our water and benzene in our air 

went through the IRIS system. 

Early in the Bush administration, the White House insisted on 

changing EPA does risk assessments. What they did is, they wanted to bring OMB, the Office of Management and Budget, and other 

agencies more directly into the process. Soon after EPA Administrator Johnson took over the agency in May 2005, he made changing IRIS and risk assessment a high priority. The GAO report I am 

releasing today criticizes the Bush administration changes to the 

risk assessment process and makes it clear that the danger faced 

by the public, when political interference and influence of polluters 

is paramount, is serious. 

Under EPA’s new approach, politics can be and already has been 

injected into multiple stages in the process. Now, no one can explain to me where there is room for politics when you are looking 

at the health and safety of the American people. Even worse, the 

new procedure effectively requires the White House, the Department of Defense, which contracts out much of its weapons programs, to agree with EPA on any risk assessment before it goes 

forward and before it is made public. So instead of having the scientists at EPA decide what is good for our health, we now have 

contractors essentially at the table. And we have the private sector 

and those with the special interests effectively at the table. 

What makes it worse is, the entire process is kept secret, which 

GAO and EPA scientists say undermines the credibility of EPA’s 

scientific assessments. That is because EPA scientists are being 

pushed aside by White House operatives and polluters. According 

to the GAO, the EPA’s flawed risk assessment process essentially 

derailed the risk assessment for TCE, a solvent that is the most 

common organic groundwater contaminant in the U.S. TCE causes 

cancer, including childhood cancer, and birth defects. EPA’s assessment for naphthalene, a component of jet fuel that the National 

Toxicology Program has found ‘‘can reasonably be anticipated to be 

a human carcinogen’’ has also been derailed. Naphthalene contaminates at least 654 Superfund National Priority List sites and many 

DOD facilities. GAO found that ‘‘DOD could face extensive cleanup 

costs’’ if naphthalene is more strictly controlled. 

And here is the irony for me. This Administration has no end in 

sight for funding of the Department of Defense. And the Department of Defense protects us all over the world. Isn’t it ironic, while 

they are doing that, they are derailing defenses against toxic 

chemicals? To me, it is the ultimate irony. 

Similarly, GAO found extraordinary delays in the risk assessment process for formaldehyde—you have heard of formaldehyde— 

a chemical in plywood and many consumer products that has been 

linked to leukemia and other cancers. An EPA scientist with extensive knowledge of this program told our Committee staff that the 

Bush administration’s risk assessment process could have ‘‘a significant impact on public health by delaying decisions so exposures 

can continue unabated to carcinogens, chemicals that cause birth 

defects and developmental effects, neurotoxic effects, 

[so] a lot of people are affected.’’ 

3 

This isn’t about affecting a few people. This is about affecting our 

people in a broad way. And how many of us have said, children are 

our future? 

This scientist also reported to us that ‘‘de facto, EPA can’t go forward’’ without White House, DOD and other agency sign-off. The 

process has, according to this knowledgeable expert, put the scientists aside and has been ‘‘taken over by the White House,’’ his 

words. 

EPA’s mission is to protect public health and our environment. 

Politics must never play a role when it comes to protecting our 

families. But as GAO has found, the series of delays has ‘‘limited 

EPA’s ability to conduct its mission,’’ and that is a direct quote 

from the GAO report. 

The role of independent scientists at EPA must be restored so 

that EPA can carry out its mission without secret interference. We 

must also strengthen our toxics laws to ensure that chemical companies are responsible for proving that their products are safe, including safe for pregnant women, children, the elderly and others 

who are most vulnerable to toxic chemicals. 

I so look forward to this hearing and hearing from our witnesses 

on this critical topic. And if you could give Senator Inhofe seven 

and a half minutes, please. 

OPENING STATEMENT OF HON. JAMES M. INHOFE, 

U.S. SENATOR FROM THE STATE OF OKLAHOMA 

Senator INHOFE. Thank you, Madam Chairman. I don’t need 

seven and a half minutes. I regret that I won’t be able to stay here 

for the whole hearing. 

Today’s hearing concerns me for several reasons. First, it was 

called to take a look at EPA’s chemical program under TSCA, at 

least that is what we were told and I think that is what the EPA 

was told. However, it now appears that a major part of the focus 

is on the changes in the IRIS program. Unfortunately, the witness 

whom the Chairman invited from the EPA, Assistant Administrator Gulliford, who runs the TSCA program, Assistant Administrator Gray runs the IRIS program. So Mr. Gulliford, while you 

might be able to offer some general comments on the IRIS program, you should not be expected to be the expert that you are in 

your own field. 

Next, my staff was repeatedly told by the majority staff that 

GAO was working on an IRIS report, but they weren’t sure if it 

would be ready in time. This report, in keeping with our Committee rules, was distributed on Friday. However, we now understand that not only was the report completed by March 7th, but it 

was Senator Boxer’s office that requested that the GAO embargo 

the report for 30 days. While this is occasionally done, Senator Boxer’s deputy staff director went even further to request that the embargo be extended until this hearing. This is not a common practice 

and I have a letter from the GAO that I would like to enter into 

the record at this time. 

Senator BOXER. Without objection, so ordered. 

[The referenced material follows:] 

4 


88900.124
5 


88900.125
6 


88900.126
7 

Senator INHOFE. My concern in all this, inviting the wrong EPA 

witness, withholding from the minority the GAO report for more 

than 50 days, is that this hearing today appears to be set up as 

a ‘‘gotcha’’ hearing to try to embarrass the Administration, instead 

of a legitimate oversight hearing. If the Chairman were truly concerned about oversight and changing policy, then she would have 

shared the report when it became available over a month and a 

half ago, and she would have invited the correct EPA witness. I understand at one point she wanted the Administrator, but she invited the TSCA Assistant Administrator. 

Oversight works best when it is done in the open. By not disclosing the true intent of today’s hearings to the agency and the 

minority, we are left with, at best, an incomplete and inconclusive 

attempt at oversight. 

I believe we need to work together on oversight, such as a hearing examining the ethanol program. This Committee has not held 

such a hearing, despite massive changes in the law last year, which 

has increased food prices contributing to riots. And by the way, I 

would like to make that as an official request. I am going to be on 

the floor today, Madam Chairman, at some length, talking about 

the mandates, the ethanol mandates and how they relate to the 

cost of food stocks. In fact, this is an area where I will be in concert 

with what normally are not my best friends on the environmental 

issues. It is something I think you agree with, that I think we need 

to determine, be concerned about this diversion of these to fuel 

from food. 

So I would like to make that request, I think we should have 

that. I will be more elaborate on the floor in talking about this, I 

have about a 1-hour speech on the ethanol mandate and how much 

that is hurting a lot of people. 

Thank you, Madam Chairman. 

[The prepared statement of Senator Inhofe follows:] 

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

FROM THE STATE OF OKLAHOMA

Good morning. Today’s hearing is to examine the adequacy of the mechanisms for 

the evaluation and regulation of chemicals by the EPA. The subject is important because the chemical industry is a crucial part of the US economy and we have to 

be mindful of what we put at risk if we over-regulate this industry and stifle its 

30 year history of innovation. 

Here are some statistics. The United States is the No. 1 chemical producer in the 

world, generating $635 billion a year and putting more than 5 million people to 

work. The US chemical industry paid more than $27.8 billion in Federal, State and 

local income taxes in 2006. More than 96 percent of all manufactured goods are directly touched by chemistry. 

But it is about more than money. 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 medical devices, such as sutures, internal tubing, and scalpels. Innovations in chemistry have made planes, 

fighter jets, and space shuttles safer and more secure. Plastics are used to make 

lighter, yet stronger, cars and silica is an ingredient in low-rolling resistance tires, 

all of which increases automobile fuel efficiency. Alternative sources of energy, on 

which cap and trade proponents are relying, are dependent on chemicals. Wind 

power blades contain polyester and resin additives and solar power relies on siliconbased materials. Finally, chemicals keep our children and our men and women in 

uniform safe by increasing the effectiveness of child safety seats, bicycle helmets, 

and Kevlar vests. I could go on and on. 

8 

The reason I point all this out is that there are many people who come to this 

hearing with a belief that the US chemicals management program is broken and 

that Congress needs to completely rewrite the Toxic Substance Control Act (pronounced TOS-KA). I do not agree. 

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 call for regulation of chemicals 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. 

There are also those who have expressed concern over EPA’s risk assessment 

practices. I am one of them. I have long been concerned about the lack of transparency and participation inherent in EPA’s risk assessment process, as well as how 

risk is communicated to the public. I was pleased with EPA’s recent changes to the 

Integrated Risk Information System. These changes allow the public to be involved 

in the risk assessment process sooner. Now, environmental groups, scientists and 

the regulated community can provide data, research and comments on risk assessments before they are finalized. Additionally, there is now a concerted outreach effort to members of the scientific community and more rigorous peer review. I understand that there are those on this committee who believe this is somehow stifling 

EPA scientists or putting politics into the scientific process. But I don’t understand 

how someone can stand up and say they support public right-to-know, scientific 

community participation and transparency when the Agency makes regulatory decisions but not support those very same principles when it comes to risk assessment. 

More science means better decisions; more defensible decisions. 

As I said 2 years ago during a toxics oversight hearing I held when I was Chairman, 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 

and perhaps we will continue to uncover implementation problems that this committee, exercising its oversight, can encourage the Agency to rectify. 

Senator BOXER. Thank you. 

I am going to just use the privilege of the Chair just to respond 

to say that I don’t mind your attacking me on this. We certainly 

did tell your staff that IRIS was a very important part. The reason, 

we really wanted Administrator Johnson here, because we think 

the buck stops there. But we also believe that TSCA and the role 

of TSCA is very important, even though the law has been weakened. This is bigger than just the IRIS program. It really is about 

all of our laws that rely upon risk assessment. But I don’t mind 

that you are unhappy with me. This is certainly not going to be the 

last time. 

Senator INHOFE. Oh, I am not unhappy with you, if you would 

me respond. 

Senator BOXER. It is not the first and it won’t be the last. But 

I just want to say this. For me, the most important thing, and I 

am sure it is for you, is not getting into an argument about the 

date of the GAO report and all that. We obviously wanted to understand it, read it and do the rest. But it was the report we had 

asked for. 

But what is important is the bottom line here, which is that we 

are being told, and this is a scandal, frankly, that our families are 

being put at risk because politics has entered the process of these 

risk assessments. And this is too important for us to bicker over 

how many days we told you this, that or the other. 

But I am happy to hold another hearing on this, and you would 

have every right to call whomever you want, and I would be delighted to do that at any time. But I really do want to thank you 

for being here, I know you have a hectic schedule. 

9 

Senator INHOFE. Let me clarify, I certainly did not attack you, 

nor would I attack you, nor will I. But on this, I think if we do ask 

for am embargo, which can be very appropriate if we share that 

with each other, it would be a better idea. 

Senator BOXER. Yes, as you say, it has been done before, and I 

will. 

All right. Senator Lautenberg. 

OPENING STATEMENT OF HON. FRANK LAUTENBERG, 

U.S. SENATOR FROM THE STATE OF NEW JERSEY 

Senator LAUTENBERG. Thank you, Madam Chairman. How nice 

it is to start off this spring day with a discussion of not the issues 

but the format or the process. And I think that if one attempts to 

hide information, the biggest obfuscation took place when we said 

that global warming is a hoax. And that tried to hide the effects 

and the seriousness of what that condition was ultimately is now, 

in front of our eyes, almost daily on TV and news, news delivery 

systems. 

So this is the kettle and the pot being called black. And Madam 

Chairman, I know you don’t need it, but stay strong on these 

things. Don’t let yourself be cowed. 

Senator BOXER. I make you that commitment. 

[Laughter.] 

Senator LAUTENBERG. Earlier this month we held a hearing on 

a matter that is still on many Americans’ minds, the impact of contaminants in our Nation’s water supply and the health hazards 

that they may pose to our residents. These contaminants include 

chemicals that are used in rocket fuel, gasoline additives proven to 

have negative effects on people’s health. The real problem with our 

water supply is the lack of regulation by EPA. When it comes to 

regulating the industrial chemicals that are used in thousands of 

everyday products, from plastics to children’s toys, the EPA is 

missing in action. The absence of EPA regulation is putting people 

at risk. 

For instance, scientific studies show a potential link between a 

chemical called Bisphenol-A, which is used to make baby bottles 

and water bottles and a host of medical problems, including cancer 

and reproductive issues arise. But here is the worst part. While the 

chemical is being developed and then used in the products we rely 

on, the EPA did nothing. Instead of speaking out for our health, 

they were silent. And the agency was not just silent about this single chemical. Out of the 80,000 chemicals used now to produce the 

products they have found throughout our homes, the EPA has only 

tested 200. It is unacceptable. 

I refuse to let my grandchildren become the newer version of the 

canary in the coal mine when it comes to determining which chemicals are safe and which are not. We need to change the system so 

instead of passively waiting for a chemical to hurt somebody, we 

prove that it is safe before it gets into the hands of the consumer. 

That is why I will soon introduce an updated version of the Kids 

Safe Chemical Act. Chairman Boxer supported this critical bill 

when we introduced it during the last Congress, and I hope we are 

going to be able to work together on it again this year. This legislation would direct the EPA to make sure that every chemical in 

10 

every product is safe before it winds up in the hands of the consumer. 

We already regulate pesticides and pharmaceuticals this way. It 

seems to me just common sense that we do the same thing for industrial chemicals that are used in everyday consumer products. I 

believe that it is, and I believe that the American public will agree. 

I look forward to working common sense back into our environmental laws to make sure the products we rely on every day are 

safe. 

Madam Chairman, as we approach the spring and we think 

about when it was that Rachel Carson started the anti-pollution 

movement, it was 1963, and it was the book called Silent Spring. 

It produced an anxiety, produced a tension to what we were doing 

to ourselves, particularly at that time with DDT. It took 9 years 

for that material to be obliterated from use and its presence. 

So this is the place and this is the time, Madam Chairman, that 

we have to get on with these things, stop talking about them and 

do something about them. Thank you very much. 

Senator BOXER. Thank you very much. And Senator, I would be 

very honored to be the lead co-sponsor on your legislation, because 

I think it gets to the heart of the matter. 

Senator BARRASSO. 

OPENING STATEMENT OF HON. JOHN BARRASSO, 

U.S. SENATOR FROM THE STATE OF WYOMING 

Senator BARRASSO. Thank you very much, Madam Chairman. 

Madam Chairman, we do need to protect our children, no matter 

what age, from the effects of harmful chemicals. I doubt there is 

anyone in this entire room today who wouldn’t support that goal. 

There is nothing we wouldn’t provide for our children. Children 

need safe drinking water, life-saving medicines and safe food to 

eat. 

One question we might ask ourselves in this hearing is the following: has the chemistry industry and the EPA, under the Toxic 

Substance Control Act, helped improve the lives and the health of 

our children? To answer that, I would like to highlight an article 

that ran on Thursday in the Washington Post, a front page article, 

and the story is entitled For Children, a Better Beginning: Study 

Finds Progress on an Array of Issues from Birth to Age Ten. 

In brief, the article says, in a wide-ranging look at how children 

have fared in their first decade of life, there is a promising picture 

of American childhood. Sixth graders feel safer at school. Reading 

and math scores are up for 9 year olds. More preschoolers are vaccinated. Fewer are poisoned by lead. 

The analysis, which created a composite index of more than 25 

key national indicators, reports an almost 10 percent boost in children’s well-being from 1994 through 2006. It goes on to say that, 

for example, the mortality rates for children ages one to four has 

declined by a third. With lead, the study reported a striking decline 

in the percentage of children younger than six who have elevated 

lead levels in their blood. The article mentions possible reasons for 

this trend, that is improved health and conditions, better Medicare 

care, better nutrition, mandatory use of seat belts, safer playground equipment. 

11 

What role has the chemical industry played in providing better 

medical care, car seats and safer playground equipment and so on? 

I think there is a role. Chemistry, using chlorine, plays a role in 

producing 93 percent of the top-selling medications in the United 

States. Children benefit from some of these drugs, including those 

that treat epilepsy, asthma and depression. The antibiotic 

Vancomycin, with which I am very familiar, which is made with 

chlorine chemistry, has saved the lives of patients suffering from 

serious, stubborn bacterial infections. 

Chemicals make prosthetic devices used as polyvinyl chloride, or 

PVC, which is a common chlorine-containing plastic used to construct prosthetic legs and arms for children who lose their limbs or 

have birth defects. Thanks to these devices, many of these children 

can lead normal lives and participate in most activities. 

PVC is used to make blood bags, IV fluid bags and tubing to deliver needed care to young patients. Incubators for prematurely 

born infants are constructed of these same plastics. The chemical 

industry also makes the plastics used to manufacture child car 

seats, safer playground equipment. 

That is not to say that it is a completely rosy scenario for today’s 

children. There are still areas of concern, such as increased rates 

of childhood obesity and also low birthweight babies. So we must 

be ever-vigilant. We need a strong and viable regulatory framework, the same framework under TSCA that has spurred advancements to help our children, not gotten in the way of it. This framework can provide the next series of advancements that can make 

the future better for all Americans. 

We must not enact policies that hamstring new chemical development that would prevent these new advancements. Otherwise that 

next child vaccine, the next bike helmet, the next prosthetic leg, 

will not be there if our families need it the most. 

TSCA has helped establish EPA as a leader around the globe in 

developing the tools we need to understand chemicals. It is a flexible statute that allows the EPA the ability to vary its assessments 

of new chemicals, according to the attributes and the expected uses 

of each substance. The framework ensures that the majority of new 

chemical substances pose little to no risk to our health or to the 

environment. Every chemical at a certain exposure is toxic. Fluoride used in toothpaste and purposely put into our drinking water, 

if ingested in massive amounts, can cause harmful health effects. 

As they say, the dose makes the poison. 

My point is that we don’t need to scare folks about risks that are 

not there or of a low probability. That is why we need a statute 

that realizes the differences between risk of exposure and toxicity. 

Is TSCA perfect? No. Could there be room for improvement? Perhaps. Could the implementation of the current Act be improved? 

Absolutely. 

GAO released a report in 1997 that made recommendations for 

improvements. Many of these need to be implemented, in particular, recommendations for improving the use of confidential 

business information, prioritization of chemicals for risk evaluation, reducing some of TSCA’s administrative burdens relating to 

chemical testing requirements and improving and validating the 

models EPA uses to assess and predict the hazards of chemicals. 

12 

With that, Madam Chairman, I welcome the witnesses and look 

forward to the testimony. Thank you, Madam Chairman. 

Senator BOXER. Thank you. 

I just would like to put in the record, without objection, a list of 

toxic chemicals that have been regulated under the IRIS program. 

That is why our kids, that is certainly a strong reason why we are 

seeing some good news on our kids. But what the White House is 

trying to do is change it, is bring politics into it. So we had, for example, under IRIS, we have had regulations about arsenic, mercury, cyanide, toluene, chlordane, DDT, PCBs, it goes on and on, 

many chemicals with very long names. 

The bottom line is, the purpose of this hearing is, we don’t want 

to go backward. Some of us want to make it even stronger, not to 

hamstring our companies from making prosthetics, I don’t know 

where that comes into it, to be honest with you. We are talking 

about protective standards in our water, in our air, not in prosthetics. So let’s not raise false issues. 

So let me just be clear about what today is about. What we have 

learned is that this program that has in fact made our kids safer 

is in jeopardy. As a matter of fact, the Administration claims under 

their new way of doing things, which they are now institutionalizing or trying to, that they would take care of 50 chemicals? Fifty 

in 1 year? 

Male Speaker. 

[Remarks off microphone.] 

Fifty. And they did two. So that is the purpose of this hearing. 

[The referenced material was not received at the time of print.] 

Senator BARRASSO. Madam Chairman, not to be argumentative—— 

Senator BOXER. You can be. 

Senator BARRASSO. Pardon me. The plastics that I have seen as 

an orthopedic surgeon for 25 years that have been used to build the 

prosthetics are advances in plastics, and they are chemically related. That was my point. 

Senator BOXER. You are right. But we are talking about regulating these chemicals in water and air. We are not talking about 

regulating them for prosthetics. We are not talking about banning 

them. We are talking about regulating them, so that kids don’t 

breathe them, drink them, play in them on Superfund sites and the 

like. 

So we are talking past each other. Nothing that you said do I object to. I am not suggesting that these be banned for prosthetics or 

anything else. I am saying we need to control these when scientists 

tell us they are going to cause birth defects, they are going to cause 

cancer. That is what we are talking about. 

Senator WHITEHOUSE. 

OPENING STATEMENT OF HON. SHELDON WHITEHOUSE, 

U.S. SENATOR FROM THE STATE OF RHODE ISLAND 

Senator WHITEHOUSE. Thank you, Madam Chair. 

I just want to express my appreciation to you for holding this 

hearing. I think it is an important hearing. We have north of 

80,000 chemicals to which American families are exposed, very few 

of them are tested for safety. In the program that currently exists 

13 

the burden of proof is on the regulators to show that they are unsafe, which makes the balance really in favor of industry rather 

than in favor of families. 

There is increasing awareness of health risks that these chemicals can cause. Unfortunately, we are also operating in an environment in which the Bush administration record on environmental 

and public health issues gives very much the impression of being 

not a part of the progress that Senator Barrasso described, but a 

counter-weight to the progress that Senator Barrasso described. 

EPA itself has too often been in the way of public protection, as 

we have seen, with particularly the CAFE standards and waiver. 

That is the most prominent. But over and over again there are 

cases, and on the occasions when the EPA does stand up for American families who face these health risks, then the Administration 

has put OMB in the role of being sort of the Administration hit 

man to knock those down. 

So I think there is a legitimate concern that the procedures that 

the Government Accountability Office has addressed in its report 

may stack the deck further against American families who don’t 

have the expertise to make this kind of determination and are relying on the Government to help provide them with a safe environment. 

So I think it is a great hearing, I am glad that you have called 

it and I look forward to hearing from the witnesses. 

Senator BOXER. Thank you, Senator, and I appreciate your leadership on oversight of EPA in general. You have been very strong 

on that, so we thank you very much. 

Senator CRAIG. 

OPENING STATEMENT OF HON. LARRY CRAIG, 

U.S. SENATOR FROM THE STATE OF IDAHO 

Senator CRAIG. Thank you, Madam Chair. 

Well, I am sitting here listening trying to determine whether this 

is a TSCA hearing or an IRIS hearing, but I will assume that it 

is the politics of chemicals. Probably that is a broader premise to 

the issue at hand. If you are going to talk about the politics of 

chemicals, and that is legitimate, you also have to talk about the 

importance of chemicals in our society today and what they have 

done for society, along with what they have done to damage society 

in one form or another. Those are all phenomenally legitimate criteria for an oversight hearing. 

And Madam Chair, I am sorry, I am going to err on the side of 

a doctor today and not a politician. I am going to err on the side 

of Dr. Barrasso and his statement because I think it was overreaching in the broad sense, not overreaching, but it reaches out 

in the broad sense to talk about striking balance and assuring 

quality human health in our Country. 

Our history is replete with the lack of knowledge and understanding as to the application of or the pollution of chemicals into 

our environment. And when we found it out, when we knew it, we 

began to move. From the very loud cry of Silent Spring, as one Senator mentioned, to what we have done effectively with TSCA, 

which is today a responsible model of public policy that works and 

brings about that kind of balance. 

14 

My great fear is not unlike what we are experiencing today in 

the petrochemical industry. When we didn’t do it they did it, meaning somebody outside our Country. And now we are being victimized because we weren’t smart enough to continue production in 

our Country and do it in a clean and responsible and environmentally sensible way. 

How many times this year has our society been warned about a 

product coming in from outside our Country that might in some 

way injure human health? The more we regulate in ways that are 

punitive, that deny a reasonable entry into the market based on 

sound science, the more someone else is going to do it offshore. The 

beauty of what our Country has always done historically is its phenomenal transparency, not just for us and our consumer when the 

knowledge base was there to do so, and a good regulatory process 

produces that knowledge base, but at the same time it was transparent to the rest of the world. 

TSCA’s importance is directly tied to entry into manufacturing, 

processing, importing, and the use and distribution in commerce as 

it relates to how we regulate chemicals. Let us also recognize the 

value of the industry itself to the economy of our Country. It just 

so happens that it is about a $635 billion industry. We represent 

22 percent of the world’s economy as it relates to the chemical industry. And we are rapidly shoving it offshore by cost of input and 

cost of regulation. That shouldn’t happen. We ought to continue to 

lead in that area, and we are not talking about just minor jobs, we 

are talking about jobs in the industry that average $50,000 and 

above, a very important industry to our Country. 

So fair and balanced oversight, absolutely, Madam Chairman. 

Political forum, shouldn’t necessarily be that, although I am not so 

surprised that it has become that. Our job is oversight to see 

whether TSCA is working, whether IRIS is working. If it isn’t, then 

we ought to make it work. More importantly, we ought to make it 

work in concert with what the rest of the world is doing to make 

sure we do it better, more cost-effective, at the same time with a 

sensitivity to human health that is paramount. 

It is kind of like where we are today, Madam Chair, with energy. 

If it isn’t clean and if it is an emitting source, we don’t want it any 

more. We are driving our energy economy into cleanliness. We 

ought to do the same thing with the petrochemical industry. And 

that isn’t run them offshore, invite them to stay in a criteria of 

public policy that allows them to prosper and provide safe products 

for the consumer. That is our job. We can make it as political as 

we want to or we can be reasonable and responsible. I would guess 

the public in the large would want us to be the latter instead of 

the former. 

I thank you and look forward to the testimony. 

Senator BOXER. Thank you. I feel compelled to respond, since my 

name was invoked, Madam Chairman, several times. 

No. 1, it is not our job to keep the chemical companies at the 

table. It might be in another committee. This is the Environment 

and Public Works Committee. The EPA has a job to protect public 

health. When it comes to the profitability of the chemical companies, let’s take that up in the Commerce Committee. Let’s look at 

that. Yes, but not as a criteria here. Our job is very straightVerDate Aug 31 2005 08:38 Aug 12, 2014 Jkt 000000 PO 00000 Frm 00018 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\88900.TXT VERN
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forward, and that is protect our people from harm, from chemicals, 

toxics. And if we hadn’t been doing it, all those statistics that Dr. 

Barrasso, if I might say, has cited, wouldn’t be there. 

Now, you have taken your stand with Dr. Barrasso. Now, he is 

an orthopedic surgeon and I am really honored to have him on this 

Committee. On the panel today, we will have a pediatrician and we 

will have an Ob-Gyn. In EPA, we have many scientists whose job 

it is to protect the public. So while we all need to be listened to, 

I have other credentials. I am a grandma, I bring those proudly to 

the table. 

But the fact of the matter is, the people who know about this are 

the people who are experts in toxic, are the people who see pregnant women, who are warning them about the toxic chemicals that 

are unfortunately ever-present. 

I also want to make one last point here, which I think is important. There seems to be all this ‘‘confusion’’ about this hearing. Let 

me tell you the title of this hearing today, no confusion, ‘‘Oversight 

on EPA Toxic Chemical Policies.’’ Policies. That means anything 

and everything is on the table. We can look at IRIS, we can look 

at TSCA. 

But politics shouldn’t be played when it comes to protecting the 

health of our families. That is one of the reasons we have this 

hearing today, because politics is being played when you have the 

White House suddenly turning its back on the science and the EPA 

and inviting to the table, through various agencies, the special interests. That is not what should be happening when it comes to 

protecting the health of the people. 

And I am a little stunned that my colleagues on the other side 

of the aisle aren’t working with us on this, because you love your 

kids and grandkids as much as I love mine, and you would throw 

yourself in front of a truck for them. Well, we may have to throw 

ourselves in front of a train for them here, because there is a train 

leaving the station with Administrator Johnson on it and President 

Bush’s OMB on it, trying to derail a very important risk assessment program that has at least done something good to keep our 

children safe. If this is going to go forward unchallenged, we are 

going to see a slowdown and a delay. And everyone says that, including the GAO. We are harming our children. 

Senator BARRASSO. Madam Chairman, since my name came 

up—— 

Senator BOXER. Well, we are not going to start that, but I will 

go back to you after we, for the first round of questions. 

Senator KLOBUCHAR. 

Senator KLOBUCHAR. Thank you very much, Chairman Boxer. 

Thank you for holding this hearing. 

Just listening to Senator Craig, I just view our role as one of 

oversight, that is correct. But it is also oversight of enforcement. 

I come at this not only as a mother who, when you think first hand 

of these baby bottles and things like that could have toxic chemicals in it, it just hits you hard, but also as a prosecutor. I have always learned you can have strong laws and politicians can stand 

up and make credits about laws. But if you don’t have the enforcement angle and you don’t have people watching over to make sure 

that these laws are being enforced, then we are not doing our job 

16 

and Congress has to come in. I believe that is what we are trying 

to do, is to figure out what is going on here. 

I come at this not naively but as someone that looks at this, look 

what happened with these toys. Who would have ever thought, and 

I don’t think anyone would believe that people want to allow 

AquaDots to morph into date rape drugs in this Country, and that 

is what happened here. That is what happened. They weren’t, our 

Country, our Consumer Products Safety Commission, wasn’t watching over these toys and they came into our Country, and they 

shouldn’t have. And this happened again and again and again, and 

finally Congress had to step in, when the Administration did not, 

and say, we need more tools, what do you need to enforce these 

laws, we will help you. What do you need? A better statute on the 

book? We will help you. And that is what happened in the last year 

in this Congress. 

So it doesn’t surprise me at all that we might have to get involved in these toxic chemicals. And I was shocked to read in this 

hearing the testimony of Ms. Annette Gellert, who is going to be 

testifying on the second panel, and I am not going to be able to be 

there for that, because have a Commerce hearing on the mortgage 

crisis going on at the same time. But I read about how she had 

blood tests done on herself and her daughter, and out of 70 toxic 

chemicals they tested for, they found 36 in the mother and 34 in 

the daughter. You figure as a mother that you are supposed to be 

able to provide your child with a safe environment and you do your 

best, and then you find that things outside of your control are coming into your home. 

I figure that in a Country with as many resources as ours, there 

is no reason that people should have to get their safety information 

from news stories or from people that are already sick in the hospital. That holds true not just for the EPA, but across all Government agencies, whether we are talking about the spinach weed, the 

pet food that we get or the drain at the community pool. These are 

all things that have gone on in this Country in the past year. 

So I am looking forward to hearing from our witnesses, Mr. Stephenson from the GAO, about how the Toxic Substance Control Act 

is being controlled, where the weaknesses have been and what we 

can do better to give Americans the sense of safety that they deserve. Thank you very much. 

Senator BOXER. Thank you, Senator. 

So we will start our panel first with James Gulliford, Assistant 

Administrator, Office of Prevention, Pesticides, and Toxic Substances, to be followed by Mr. John Stephenson, Director, Natural 

Resources and Environment, from the General Accounting Office, 

who did this report. 

Mr. GULLIFORD. 

STATEMENT OF THE HON. JAMES GULLIFORD, ASSISTANT ADMINISTRATOR FOR PREVENTION, PESTICIDES AND TOXIC 

SUBSTANCES, U.S. ENVIRONMENTAL PROTECTION AGENCY 

Mr. GULLIFORD. Good morning. I appreciate the opportunity to 

share with the Committee our progress to date as well as new efforts underway to protect human health and the environment from 

the adverse effects of chemicals as authorized under the Toxic SubVerDate Aug 31 2005 08:38 Aug 12, 2014 Jkt 000000 PO 00000 Frm 00020 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\88900.TXT VERN
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stances Control Act. TSCA provides EPA with the authority to review and manage risks from new chemicals and to collect health 

and safety data as well as production, use, and exposure information on industrial chemicals. 

We use sophisticated models to assess chemicals, we facilitate 

pollution prevention and we implement voluntary programs to support our regulatory framework. We work closely with the domestic 

and international community. As an example, we have collected 

health and safety data on 2,200 high production volume chemicals 

which cover more than 93 percent of the organic chemical production volume. EPA has also successfully used TSCA to bring about 

the phase-out or significantly reduce the production, use or release 

of various chemicals, including PFOS, PFOA and other priority 

chemicals. There are many more accomplishments detailed further 

in the written testimony I have submitted. 

Overall, while no law is perfect, TSCA provides broad authority 

for the agency to adequately control new and existing chemicals 

and to address emerging chemical issues as they arise. As I said, 

while there are real accomplishments, we know there is more to be 

done. So this past August, the countries of North America came together to accelerate and strengthen the management of chemicals 

in North America. This new effort we now refer to as ChAMP, the 

Chemical Assessment and Management Program. 

We believe these efforts will significantly improve what we know 

about industrial chemicals, and will allow the Agency to pursue 

necessary protective actions or mitigation if needed. We have committed, by 2012, to complete initial assessments and initiate needed actions on over 6,700 high production and moderate production 

volume chemicals. This builds on the work that EPA has done 

under the HPV challenge program, to obtain and assess screening 

level hazard and environmental fate information and use this new 

information reported under the TSCA inventory update regulations. 

To meet these commitments, EPA is developing risk-based 

prioritizations for HPV chemicals based on hazard, exposure and 

risk screening characterizations. For the moderate production volume chemicals, we will rely on available data, Canada’s work on 

chemical categorization and EPA’s expertise in structural relationship analysis to prepare initial assessments. There is a down payment on these commitments. We have already posted hazard characterizations on 238 chemicals and in March, posted an initial set 

of risk-based prioritizations for 19 chemicals. These characterizations, which we make available on our website, provide important 

scientific information and analysis on hazards, exposure and risks, 

and position us to take any needed follow up actions. The 2012 

commitment for completing the North American assessment work 

also sets up opportunities for cooperation with the European 

Union, given the timing of the REACH registration schedule, which 

extends from 2010 through 2018. 

To foster cooperation, we have regular consultations with officials 

from the European Commission and OECD countries. It is vitally 

important to invest in this cooperation, to leverage work, avoid duplication and improve the protection of public health and the environment, both at home and abroad. 

18 

While we support the health and environmental goals of REACH, 

we believe that effective protection can be obtained through a more 

targeted and strategic approach to chemical assessment and management under our ChAMP efforts. In addition to the above commitments, where work is already underway, we are asking for feedback on potential enhancements to the ChAMP program, which 

combined with our 2012 commitments would provide the most comprehensive approach to dealing with chemicals that has ever been 

developed by the Environmental Protection Agency. 

The first enhancement involves developing a program similar to 

the HPV challenge, but for inorganic HPV chemicals. The second 

enhancement under consideration would reset the TSCA inventory 

to better reflect the chemicals actually made, imported and used in 

the U.S. We have begun an extensive effort to invite input from a 

wide range of stakeholders. 

I would like the Committee to know that the IRIS process that 

has been discussed today and the revisions to the process are managed by Dr. George Gray, the Assistant Administrator of EPA’s Office of Research and Development. It is my understanding that 

ORD senior staff have already briefed the Committee on this effort. 

Of course, the TSCA program does utilize the IRIS data base as 

a resource for reviewing chemicals, like our efforts under ChAMP. 

We work directly with ORD on a handful of assessments that are 

of particular relevance to us, like PFOS and PFOA. Again, while 

the IRIS data base provides my office with useful input, ORD is the 

lead for the overall process, and they would be best able to respond 

to questions on the recently announced process revisions. 

I am pleased to be here to share with you the highlights of our 

chemicals work. We remain appreciative of the ongoing interest of 

this Committee in TSCA and our new efforts under ChAMP. I believe that TSCA provides EPA with the statutory tools necessary 

to protect public health and the environment, and the agency looks 

forward to continuing to work closely with members of this Committee, your staff and others from GAO. 

Thank you. 

[The prepared statement of Mr. Gulliford follows:] 

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Senator BOXER. Mr. Stephenson, thank you. 

STATEMENT OF JOHN B. STEPHENSON, DIRECTOR, NATURAL 

RESOURCES AND ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY OFFICE 

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

Committee. 

GAO has issued several reports on EPA’s implementation of 

TSCA and EPA’s voluntary programs to control dangerous chemicals. We have concluded in this work that TSCA is outdated, cumbersome and difficult to use in controlling the more than 80,000 

chemicals currently in the inventory. 

Since TSCA was enacted in 1976, EPA has used its authority to 

require chemical industry testing for fewer than 200 chemicals, 

that is in 30 years, and has issued regulations to limit or ban the 

production of only 5 chemicals or groups of chemicals in that same 

time. Voluntary programs provide EPA useful information, but 

they don’t negate the need to overhaul TSCA. 

In comparing the U.S. approach for controlling dangerous chemicals under TSCA to the European Union approach under the 

REACH program, we note that TSCA places the burden of proof on 

EPA to demonstrate that the chemical poses a risk to human 

health before it can regulate its production or use, whereas in Europe, REACH generally places the burden of proof on the chemical 

industry to ensure that chemicals do not pose such risks or that 

measures will be taken for handling chemicals safely. 

My written statement includes additional information from the 

toxic chemical control reports we have issued over the past couple 

of years, but I want to focus my comments today on our new report 

concerning EPA’s Integrated Risk Information System, or IRIS, a 

data base that contains EPA’s scientific position on potential health 

effects of exposure to more than 540 toxic chemicals. IRIS is a critical component of EPA’s capacity to support scientifically sound environmental decisions, policies and regulations. 

In summary, we found that the IRIS data base is at serious risk 

of becoming obsolete, because the EPA has not been able to routinely complete timely, credible assessments or decrease its backlog 

of 70 ongoing assessments. Our report recognizes steps EPA has 

taken to improve IRIS since 2000, such as increasing funding and 

centralizing staff, but points out that these efforts have been 

thwarted by new OMB-required interagency reviews, the growing 

complexity and scope of chemical assessments, EPA decisions to 

delay assessments to wait for new research or additional uncertainty analysis on a given chemical and the compounding effects of 

delays. 

While EPA has prepared over 32 toxic chemical assessments for 

external review in the past two fiscal years, only four have been 

finalized. Comments by the National Academies on EPA’s assessment of trichloroethlyene or TCE highlight the problem. In 1998, 

EPA initiated a risk assessment of TCE, a degreasing agent used 

widely by the Department of Defense and others. EPA’s Science 

Advisory Board approved the draft risk assessment for public comment in 2001. DOD and others raised questions about the assessment, which led to a National Academies review. The Academies 

27 

specifically noted in its 2006 report that the risks of TCE were substantial and that additional studies were not necessary to finalize 

an assessment needed to protect public health. 

Nonetheless, after more than 10 years, TCE is back at the draft 

development stage. To get EPA moving, Senators Clinton, Boxer, 

Lautenberg, Kerry and Dole, spurred by TCE contamination in 

drinking water at Camp LeJeune, introduced a bill last August 

that would require EPA to complete its risk assessment and issue 

a drinking water standard in 18 months. 

Our report contains eight specific recommendations to EPA for 

streamlining the IRIS program, improving the transparency and 

credibility of its assessments and ensuring that EPA has the requisite independence to achieve these goals. EPA agreed to consider 

our recommendations in its February comments on our draft report. EPA released its revised IRIS assessments process after the 

report on April 10th. 

It is an understatement to say that we are disappointed in EPA’s 

response. The revised IRIS process is not improved and is in many 

respects worse than the draft we reviewed. For example, transparency is a cornerstone of sound science. And the draft IRIS process we reviewed would have made comments from other Federal 

agencies part of the public record. 

However, EPA’s new process expressly defines such comments as 

deliberative, excluding them from the public record. This new process will exacerbate the problems we identified in our report and 

sought to address with our recommendations, all of which were 

aimed at preserving the viability of this critical data base, which 

is integral to the EPA’s mission of protecting the public and the environment from exposure to toxic chemicals. 

In light of the importance of the IRIS program, we believe that 

Congress should consider directing EPA to suspend implementation 

of its new IRIS process and develop one that is responsive to our 

recommendations for a streamlined, fully, not selectively transparent process aimed at improving the timeliness and credibility of 

IRIS assessments. EPA should also seek congressional and public 

input before finalizing IRIS. 

Madam Chairman, that concludes the summary of my statement. 

[The prepared statement of Mr. Stephenson follows:] 

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Senator BOXER. Thank you very much. 

We will do 5-minute rounds and probably have two rounds. 

Mr. Gulliford, what chemicals have you banned or regulated 

under TSCA that were not voluntary withdrawn or regulated by 

the industry or by Congress since you took over? 

Mr. GULLIFORD. Thank you, Madam Chair. 

We regulate and take regulatory actions related to chemicals almost daily. Every year, we receive about 1,200—— 

Senator BOXER. No, no, no, I—— 

Mr. GULLIFORD [continuing].—for new chemicals—— 

Senator BOXER. I am not asking you that. How many have you, 

in your position, chemicals have you either regulated or banned 

without them being withdrawn or regulated by the industry itself 

or banned or regulated by Congress? Do you have that number off 

the top of your head? 

Mr. GULLIFORD. The actions that we take, our actions at EPA, 

do reflect our work, which in effect has the impact of determining 

whether chemicals are brought into production or not. 

Senator BOXER. I know, but I’m asking you—— 

Mr. GULLIFORD. Those are regulatory actions. 

Senator BOXER [continuing].—for a specific answer. And so you 

don’t have it. So will you please send to me in writing the lists and 

names of chemicals that under TSCA, since you took over, have 

been either banned or been regulated other than those that the industry itself decided to do or Congress took into its own hands, 

which we have done. So if you could do that, I would be really appreciative. I understand the process. I am trying to get to what 

have you done in your position. 

[The referenced material follows:] 

Senator BOXER. Now, Mr. Stephenson, the GAO report states 

‘‘The farther removed the scientists and experts who have prepared 

or peer-reviewed the assessments are from the negotiations and decisions over assessment changes requested by OMB and other Federal agencies, the decisions are based more on political rather than 

scientific considerations.’’ I think that is important, because Senator Craig kind of accused this Committee of playing politics. The 

whole point is, the GAO report says that there is political considerations. 

So how important is it to ensure that IRIS assessments are 

based on solid science rather than political considerations? 

Mr. STEPHENSON. According to the National Academies, there are 

two components there is a risk assessment part and there is the 

risk management part. The management part is where you consider political input or other circumstances, you do cost benefit 

analysis and decide regulatory approaches. 

However, in the risk assessment process, you don’t want—— 

Senator BOXER. That is what I am talking about. 

Mr. STEPHENSON [continuing].—anybody but scientists involved. 

Senator BOXER. Right. That is the point. 

Mr. STEPHENSON. That is our major problem with the lack of 

transparency and the new process is that any comments that EPA 

receives from either the Department of Defense, NASA or OMB 

itself are withheld from the public. 

62 

Senator BOXER. That is the second question. But the first point 

I want to reiterate that you made, I think it is critical here, is that 

in the risk assessment part of this, it should be pure. It should be 

about the health of people, is that right? 

Mr. STEPHENSON. Absolutely. 

Senator BOXER. Absolutely. OK, that is No. 1. 

Now, second, the secrecy which you raised. My understanding is, 

in your report you say that the comments made by these other entities are kept secret by the White House. You find a problem with 

that, I certainly find a problem with that. Why do you think this 

is the case? Do you have any thoughts? 

Mr. STEPHENSON. I think that the OMB is muddling the two 

parts of the process. They are getting involved in the science portion, the early assessment of chemicals, when they should be getting involved in the later, what should the regulatory approach be, 

what is the least burdensome approach we can do to regulate this 

chemical. They should not be muddling in the front part, in the 

science. 

Senator BOXER. OK. Mr. Gulliford, doesn’t EPA’s Office of Prevention, Pesticides and Toxic Substances rely on information from 

IRIS in their work to help prevent, to help protect public health? 

Mr. GULLIFORD. With respect to our chemicals program, yes. 

There are a number of the IRIS characterizations that are important to us. Through our ChAMP work, we are looking at doing well 

over 7,000 chemical assessments. 

Senator BOXER. But I am just trying to get at the point about 

IRIS here. So you do, in some cases rely on IRIS? 

Mr. GULLIFORD. We have asked that certain chemicals be studied 

under IRIS and taken through the IRIS process. 

Senator BOXER. Good. That is an important point. So don’t you 

want to ensure that your office uses the best available science to 

protect public health and not secret information that is tainted by 

outside interests? 

Mr. GULLIFORD. We do that every day. We utilize the best 

science that is available—— 

Senator BOXER. Well, you count on IRIS, you count on the IRIS 

program for certain of these, and we have been told by the GAO, 

not by me or anybody else, that politics is in the process. So when 

you now hear, you get your information ipso facto, if GAO is right, 

and I tend to believe them, they have a reputation for integrity and 

they have no axe to grind here, you are getting tainted information. 

And that is a problem. 

Senator BARRASSO. 

Senator BARRASSO. Thank you very much, Madam Chairman. 

Early you mentioned about my background and training as an 

orthopedic surgeon. The derivative of orthopedics comes from the 

Greek, and it is the word ortho, meaning straight, and paedos, 

meaning child. So lots of the training I do is with children and I 

have very significant concerns in those areas. 

Mr. Gulliford, if I could, I mentioned earlier this Washington 

Post story about all the advances in children and kind of getting 

the lead out of the system. Isn’t that something EPA should take 

credit for? 

63 

Mr. GULLIFORD. EPA has worked with HUD and with other 

agencies for many years on issues of lead. We are very pleased 

that, for example, or the last 20 or so years ago, we have gone from 

as many as 3 million children affected by elevated blood levels to 

now where CDC estimates roughly 300,000. We are also very 

pleased with our new lead rule, which we believe will actively help 

again to prevent exposures to lead. 

Senator BARRASSO. When you look at exposures in terms of assessing risk to humans, don’t you really assume the worst case scenarios in terms of an exposure and try to stay below those numbers? 

Mr. GULLIFORD. We look for realistic exposure estimates. We 

build in safeguards to assure that we don’t approach those exposure thresholds that we believe are dangerous or threatening. 

Senator BARRASSO. If we take a look at this one size fits all approach to so many things I see happening in Washington here, if 

you used that approach to every chemical under TSCA, wouldn’t 

you end up wasting a lot of your time on some low priority chemicals and really deflecting from the real issues affecting our children? 

Mr. GULLIFORD. We absolutely would be. One of the things that 

I believe is most important is that we find a way to prioritize our 

work, to identify those chemicals of concern with respect to health 

of children, adults, all our people and the environment. That is why 

in our ChAMP program, we have developed a prioritization process 

to identify those chemicals and then follow up with industry to assure that exposure of those chemicals does not occur either to 

workers or the environment or to people that use products that are 

produced from the use of those chemicals. 

Senator BARRASSO. So I take it then that you don’t always agree 

with the chemical industry, or shall I say the chemical industry 

doesn’t always agree with you? 

Mr. GULLIFORD. No, absolutely not. Our work is to evaluate the 

data that they give us and make independent decisions by the 

agency, rather than to allow industry alone to make decisions. 

Senator BARRASSO. Thank you, Madam Chairman. 

Senator BOXER. Thanks. I just want to let the record show that 

the lead, the progress on lead was made under the old rules, which 

is what we are trying to defend here today. And that will show, because that is one of the good things that happened under the old 

way. 

Senator Whitehouse. 

Senator WHITEHOUSE. Thank you, Madam Chair. I am not sure 

it is part of the record, so I would just like to start by showing Mr. 

Gulliford the picture of the IRIS process. I believe we got this from 

EPA staff. And I just want to make sure that this is correct. 

It shows, before 2004, an IRIS process that was already pretty—— 

Senator BOXER. Would you bring that over to Senator 

Whitehouse and show it—— 

Senator WHITEHOUSE. And then, well, hold on a second. 

Senator BOXER. That is the new one. Where is the old one? 

We don’t have it. So show that old one, and then we will show 

the new one. 

64 

Senator WHITEHOUSE. It starts already looking pretty complicated with 11 steps here. Then from 2004 to 2008, it started to 

look more like this, it went from 11 to 15 steps—— 

Senator BOXER. That is the one. 

Senator WHITEHOUSE [continuing].—and became every more 

complicated. And now the draft process looks like this and has all 

sorts of, I can’t count the number of steps and sub-steps that it has. 

It just looks to the lay viewer as if this process is getting more complicated and cumbersome. 

In addition, I am concerned about the role that OMB plays being 

injected into the process relatively early on. What scientific expertise does the Office of Management and Budget bring to the table 

in these discussions about risks of chemicals? 

Mr. GULLIFORD. Let me start with your first question and your 

comment on the complexity. That board also can demonstrate the 

fact that an effort is being made to be more explicit about all of 

the steps and to further or better define them, as well as perhaps 

adding steps. So there are a couple of things in effect there. 

OMB has scientists and economists and professionals that work 

for them as well. Their role principally, though, is to assure effective interagency review. It happens with rules, it happens with 

other programs. And the agency does believe that in the IRIS process, interagency review, opportunity for interagency input into the 

process, as well as public input, public review and finally science 

review as well by third party outside scientists, all of those are important parts of the IRIS process. 

Senator WHITEHOUSE. Should we have concern about the private 

nature, the non-public nature of OMB’s review? As I understand if, 

it you are an American company who wants to comment on this, 

on a piece, on an administrative process, a chemical that is being 

put through the IRIS process, your comments have to be public. 

And if you are an American advocacy group, if you are the Heart 

Association or the Cancer Society and you want to comment on it, 

your comments have to be public. And if you are an American mom 

or citizen who wants to comment on it, your comments have to be 

public. 

The carve-out is for other Federal agencies. And what it seems 

to create is a loophole where, if you want to influence this process 

and you don’t want to say it publicly, you go to a White House, you 

get them to tell OMB what to do, because it is part of the White 

House, and you can stick whatever comments you want in, and it 

is a way to launder comments you wouldn’t make publicly through 

politics and into this. Isn’t that a legitimate concern? 

Mr. GULLIFORD. That is an assumption that you are making. I 

am not certain that would or wouldn’t happen. I don’t believe that 

it would. 

Senator WHITEHOUSE. Is there anything in the process that 

would prevent that from happening? 

Mr. GULLIFORD. There is the allowance for the agency to review 

mission-critical chemicals and that be a protected process. 

Senator WHITEHOUSE. How does that keep OMB out, if OMB has 

been made amenable to political—— 

65 

Mr. GULLIFORD. You are making the assumption that OMB is 

made amenable to that political process, in the Office of Management and Budget for interagency review, as I had stated earlier. 

Senator WHITEHOUSE. You know, one of the things we do in 

American Government is we have things be transparent and aboveboard so we can prevent things from happening. So it is usually 

wise, when you see a system that create an avenue for that kind 

of politics to happen, to press on it and try to figure out why the 

system wouldn’t protect itself against that. If you leave a door open 

to that, I don’t think it is an adequate public protection to say, 

well, we can’t prove that it is being used for that purpose is because the very process keeps it private and confidential and out of 

the public view, allows it to be done behind closed doors. That 

doesn’t seem right, does it? 

Mr. GULLIFORD. The final products of the IRIS process are reviewed by third party science organizations. That is the purpose, 

that ultimately, when EPA has gone through the process, EPA has 

heard input from the public, EPA has heard input from agencies, 

EPA has heard, people have been given the opportunity under this 

process to bring data, bring information, to bring opinion to the 

process, ultimately it is still, at the end of the day, it is EPA’s decision. EPA makes the determinations on those final IRIS characterizations. And then they are split out for third party review. 

So I believe it is a transparent process. It is a process that ultimately results in a science-based result. 

Senator WHITEHOUSE. Madam Chair, my time has expired. 

Senator BOXER. Yes. I thank you, Senator. I just want to say, Mr. 

Gulliford, and you are a very good witness, but Senator Whitehouse 

is not the one making these charges. GAO said this thing is so secret they talked about a black box, that this information that you 

say is public is never public. It is actually in a black box, it is secret. 

So when you say to Senator Whitehouse that he is not correct, 

he is relying on the investigation of this process. 

Mr. GULLIFORD. I apologize. Senator Whitehouse asked the question, that is why—— 

Senator BOXER. I understand, but I just want to make sure that 

we understand the GAO makes this point. It is not an individual 

Senator. He is just reiterating what we now know is the truth 

about the process. 

Senator CRAIG. 

Senator CRAIG. Thank you, Madam Chair. 

Gentlemen, thank you very much for your testimony. I am trying 

to understand the process, because it appears that it is the process 

that is under attack today and not the outcome. I think we are obviously concerned about transparency. We are also very concerned 

about outcome. 

Something that has not been mentioned, and I ask you, Mr. 

Gulliford, does it fit into the process, and that is, how many premanufacturing notices has the EPA received versus notices to commence? Now, the reason this is important, when we are talking 

about propriety and ownership of product and development of product, part of the value of the ownership is the chemistry and the formula. 

66 

But it is important to understand that as it relates to human 

health and understanding. So the question then is, because it appears that in pure transparency you get nothing done, because 

someone else can steal your work product. At the same time, you 

want to make sure your work product, the end process, is safe for 

human consumption and association. 

So the question again is, how many pre-manufacturing notices 

has EPA received versus notices to commence, meaning to commence production once the process is completed? Could you respond 

to that? 

Mr. GULLIFORD. We get about 1,200 PMNs each year. 

Senator CRAIG. And a PMN is? 

Mr. GULLIFORD. Pre-manufacturing notice. I am sorry. 

Senator CRAIG. Thank you. Use common language for us, would 

you please. 

Mr. GULLIFORD. I appreciate that. Since TSCA, roughly 47,000 of 

those PMNs. We have added 21,000 new chemicals to the chemical 

inventory, which means that during that process, during our regulation of those notices, our evaluation of those chemicals, our concerns for those chemistries, our interaction with those companies, 

because as you say, much of that is confidential business information. Those chemicals are either withdrawn because, by our work 

with them, they have come to the conclusion that they are not an 

appropriate chemical for us, or ultimately some of them do make 

it through the process, roughly, I think 21,000 since TSCA. 

Senator CRAIG. But percentage-wise, I understand it is around 

the 50 percent mark. 

Mr. GULLIFORD. Or less. 

Senator CRAIG. Or less. Those who are, that which is submitted 

for testing and oversight, or review, through the process, versus 

that which actually makes it to the market. And often they are 

withdrawn, are they not? 

Mr. GULLIFORD. That is correct. 

Senator CRAIG. For future research to meet the compliance 

standards that you say they must meet. 

Mr. GULLIFORD. That is correct. 

Senator CRAIG. I see. I guess my next question, because Mr. Stephenson says we ought to stand down and review, I think I understand you right, and reapproach IRIS differently, and in that, you 

have referenced REACH. REACH, of course, is what the European 

Union uses. So that is your observation. 

So let me ask a question, Mr. Gulliford, has EPA examined 

REACH and its thoroughness or its responsiveness? Because it is 

being touted here today as something that is working or is more 

transparent or is more inclusive, versus what you are doing. And 

first of all, let me ask you that. I understand there are about 

30,000 chemicals that the EU will need to register. How do you 

think it compares? We have already heard from Mr. Stephenson 

about he thinks it compares. 

Mr. GULLIFORD. REACH is a regulatory chemical management 

scheme that is now in place in the EU. It is just now beginning 

to collect the information that is required, the testing, the data 

that will be developed by industry for their estimate again is 

67 

roughly 30,000 chemicals. We will see how many are actually produced by them and submitted. 

So at this point in time, they are still in the data development 

and information development testing mode, and as of yet, decisions 

under REACH with respect to chemicals have not been made. 

Senator CRAIG. So from your point of view, you don’t know that 

a conclusion can be drawn as to its effectiveness? 

Mr. GULLIFORD. I think it will be. The effectiveness of REACH 

will at some point in time be known and evaluated and we will see 

the benefits of it. 

Senator CRAIG. Now, I have portrayed what I think you said, Mr. 

Stephenson, to be fair. Your reaction to the comment of Mr. 

Gulliford. 

Mr. STEPHENSON. If I could clarify. 

Senator CRAIG. Please do. 

Mr. STEPHENSON. TSCA is the regulatory approach. 

Senator CRAIG. I understand. 

Mr. STEPHENSON. We are talking about—— 

Senator CRAIG. Well, we are not sure what we are talking about. 

Mr. STEPHENSON. We are talking about standing down the toxicity assessments under the IRIS program, which is a forerunner 

of regulation. You have to determine how toxic a chemical is, first. 

Senator CRAIG. I understand. 

Mr. STEPHENSON. We have other problems with TSCA in that it 

is cumbersome, it requires a two to 10 year test rule in order to 

get information from the chemical industry, information that is already provided up front under REACH from the chemical industry. 

So we are kind of mixing apples and oranges here. 

Senator CRAIG. But in our observation, or excuse me, in your observation of REACH, which is a new program in the EU to attempt 

to register and to clarify the value of or the problems with 30,000 

chemicals, can you at this time assess its quality of work and production and its time lines? 

Mr. STEPHENSON. It is probably too soon to tell, except that we 

get much more information, the Government gets much more information from the industry with REACH than it currently does 

under TSCA without heroic efforts. And it is more of a partnership 

with the industry, because the industry understands what information it must provide to the regulatory agency. The chemical companies here that do business in Europe must subscribe to REACH. So 

it is not foreign for them to handle that regulatory framework. 

Senator CRAIG. So in other words, is it reasonable to assume 

then, in REACH, I can’t condemn it yet because I don’t know about 

it, or we don’t have a track record of its effectiveness, where we 

have chemical companies—— 

Senator BOXER. Senator Craig, I just—I am not going to stop 

you—— 

Senator CRAIG. This is the last question. 

Senator BOXER. No, no, no, let me finish. I will give you an extra 

2 minutes, because I think we will have a second round in a few 

minutes, so you can use your second round now. 

Senator CRAIG. Then wouldn’t it be responsible for us, instead of 

throwing the baby out with the bath water, to look at our process 

and REACH, once it is implemented, through the eyes of, in part, 

68 

of the chemical companies that have to deal with both and see 

which one is the most effective, the most transparent, assures proprietaries needs necessary for a chemical industry to exist and 

assures human safety. 

Mr. STEPHENSON. We are not subscribing the REACH approach. 

What we have done over the last few years is look at TSCA and 

talk about how it is cumbersome to use and how it needs overhauling. We have made specific recommendations on our legislation, our regulatory approach, on things that need to be improved. 

All we are suggesting is that REACH offers a model for front-end 

information from the chemical industry that we might consider as 

we overhaul TSCA. 

Senator CRAIG. Thank you. Gentlemen, thank you much. 

Senator Klobuchar, if you want, I will give you 7 minutes, that 

would cover your next round. 

Senator KLOBUCHAR. No, I am just fine. 

Thank you to both of you. I want to follow up on some of Senator 

Craig’s questions with you, Administrator Gulliford, about the European Union. What I understand, regardless of the effectiveness 

in the long term, is that they are going to be receiving a tremendous amount of information on the safety of chemicals in the coming years under this new law, which is REACH, which standards 

for Registration, Evaluation, Authorization and Restriction of 

Chemical Substances. So is the EPA going to request this information on chemical risks from the European program to make sure 

that our Country has this same up to date and current information 

that they are going to have in Europe? 

Mr. GULLIFORD. Thank you, Senator, that is a very good question. In fact, we are working now with the EU members, with the 

EU Commission to make sure that there is a portal that allows for 

access of that information. 

Now, having said that, we believe that it is appropriate for us 

to determine through our process which chemicals we believe are 

most appropriate for our work, for our follow up actions with respect to those chemistries. We do believe that if the REACH process follows through and generates the data that we expect that it 

will, at a certain point in time, because I said to you, we would be 

committing to completing our prioritization work by the year 2012, 

that we will have at that time an opportunity to select from that 

data that is available through REACH. So it is possible that we 

will use that data. But it is also very probable, there are those 

30,000 chemicals, there will be a lot of those that we won’t find a 

need for that data as well. 

Senator KLOBUCHAR. So are you going to get that data in the 

next month, or when are we going to get it? We have a panel coming up that is concerned about the health risks here. I know we are 

working through with the EU, but I would think we would want 

that immediately. We have good relations with them. 

Mr. GULLIFORD. It is industry’s obligation to transmit that data 

to the EU between the timeframe of, I believe 2010 and 2018. So 

as that data is transmitted, we will know its availability. We will 

also be able to again, by looking at the work that we propose to 

do, not on 30,000 chemicals by on our high production or moderate 

production volume chemicals, roughly 7,000, we will have identified 

69 

the chemicals that we believe are most appropriate for action. We 

will be able to go after that data if we do believe that it will be 

helpful to us. 

Senator KLOBUCHAR. But wouldn’t you just rather get the data 

ourselves than have to go through the EU? It seems to me, just getting to Mr. Stephenson’s point, that we should be, the agency itself, 

which knows the most about this law, should be pushing to update 

our laws so we get that information. 

Mr. GULLIFORD. We will have access to the data when we need 

it. I think it is more appropriate—it is not our interest to be a data 

manager, it is to be a data user. I think the most important thing 

that we can do at EPA is utilize valuable data when we need it in 

a way that allows us to make effective decisions. 

Senator KLOBUCHAR. OK. Mr. Stephenson, do you feel it is fair 

to say that agency officials in Europe are going to have access to 

more information on potential threats from chemicals when their 

new law kicks into gear than we will have in the United States? 

Mr. STEPHENSON. It does under the old law, and they will get 

more under the new law. There is a table in the back of one of our 

TSCA reports that does a side by side comparison of what we get 

under TSCA versus what we get under REACH and the Canadian 

approach, for that matter. 

Senator KLOBUCHAR. And what types of information, I will go 

back and look at that table, but could you give me the greatest hits 

of information they are going to have? 

Mr. STEPHENSON. It is characteristics of the chemicals, but it is 

also any risk assessment data they have done, any tests they have 

undertaken. They certify to all that data before it is provided, before a chemical is approved for production. 

Senator KLOBUCHAR. Could you talk a little bit about the, earlier 

you mentioned the need to update these laws, including adequate 

testing of chemicals, how can we expand that authority under 

TSCA, if we were to look at revamping this law? 

Mr. STEPHENSON. Are you talking about TSCA or the risk assessment process? 

Senator KLOBUCHAR. The risk assessment process. 

Mr. STEPHENSON. The risk assessment process, again, TSCA is a 

regulatory approach. We are concerned with the scientific basis for 

the regulations that is the IRIS program. We are so concerned 

about OMB involvement here that not only are the comments from 

the interagency review process not given to the public like every 

other piece of science input is given, but they are actually dictating 

which assessments EPA can undertake. They had them withdraw 

five that the Clean Air Office wanted. 

Senator KLOBUCHAR. They had them withdraw, what was that? 

Mr. STEPHENSON. Withdraw assessments on five chemicals that 

were needed by the Office of Clean Air, because they were acute 

assessments, which means short-term assessments that the Clean 

Air Office needed for its Air Toxics program, for example. Mr. 

Gulliford said he uses the data in IRIS and suggests studies that 

were being done. Well, that is exactly what happened, the Clean 

Air Office asked for these, OMB said no, they are not important, 

we are not going to do those. 

70 

So it’s not only the transparency in the commenting process that 

is important, it is EPA’s independence in controlling which assessments they do. The scientists at EPA must have independence. 

Senator KLOBUCHAR. And you believe that the transparency, I 

believe as a child of a journalist that transparency is very important if you want to get to the truth. 

Mr. STEPHENSON. It is a principle of sound science. 

Senator KLOBUCHAR. Right, that kind of transparency. It is also 

going to get at decisions that they make, because you think that 

we want to, and Mr. Gulliford claims they are not biased in any 

direction, but that if we want to get all that information out there 

we have to basically open it up. 

Mr. STEPHENSON. Right. 

Senator KLOBUCHAR. Do you have other examples of other agencies from a GAO perspective where they are allowing for these comments to be seen? 

Mr. STEPHENSON. Well, in any scientific risk assessment, ask the 

National Academy, ask the National Science Foundation, any scientific body understands the importance of any research that is offered, any comments that are made on the risk assessment to be 

available to the public, so the scientific community can look at 

those and decide their worth. 

The fact that after that process is done, it is offered to peer review and the public, doesn’t forgive that transparency in the earlier 

part of the process. So it is just a cornerstone of sound science, and 

that is why we are so passionate about this intervention in the 

process. 

Senator KLOBUCHAR. I appreciate it, and I also appreciate your 

bringing this out to us in your own manner. I just, when I look at 

the history that we have seen in this Committee with the involvement in some of the politics in this science, I have always appreciated how people have been willing to come forward and tell us we 

could do a better job if we just had all the information out there. 

I am very hopeful that will change within the next year. Thank 

you. 

Senator BOXER. Thank you. 

Here is what we are going to do. We are going to have a second 

round, and we will start with Senator Barrasso, go to Senate 

Whitehouse, 2 minutes each. And I don’t have any further questions, so I will just make closing remarks. 

But before Senator Klobuchar leaves, we just got word that a 

Federal judge has found the Bush administration guilty of violating 

the Endangered Species Act and ordered the Administration to 

issue a final listing decision for the polar bear by May 15th. The 

reason I bring it up is that this Committee has been on this case 

for quite a while. I wanted everyone to know that. I am pleased 

about that. 

Senator Barrasso. 

Senator BARRASSO. Thank you, Madam Chair. 

Mr. Gulliford, just one last question. On products that are already on the market, when it comes to issues of safety risks for our 

children, does the EPA have the appropriate authority under TSCA 

to go back and require new information, promote research, require 

71 

testing on products already on the market? Do you feel you have 

the authority to go do what needs to be done? 

Mr. GULLIFORD. Yes, we do have the authority to issue test rules, 

yes. 

Senator BARRASSO. Thank you, Madam Chairman. 

Senator BOXER. Senate Whitehouse. Senator Whitehouse, I will 

give you a minute of my 2 minutes, so you have three. 

Senator WHITEHOUSE. As I understand it, OMB gets involved at 

the very get-go when nominations as to what drug will be considered are first brought forward. Is that what you were referring to, 

Mr. Stephenson, the early decision? 

Mr. STEPHENSON. I don’t know whether that happens routinely, 

but it has happened. 

Senator WHITEHOUSE. Yes. It looks like there is room for it right 

in the process to happen routinely. Then there is an OMB interagency review which I think is what we were referring to, Mr. 

Gulliford was referring to a minute ago when he said that it was 

then followed by other public comments on review and that provided for some transparency, because you couldn’t see what they 

said, you could at least see what change resulted. 

But it looks to me like when you get down here to the bitter end, 

here is OMB again with a second bite at the apple, and from there 

it goes to a reviewed internal assessment that address the OMB 

interagency comment to the EPA for clearance and out without any 

further comment. So I don’t see how it is true, what you told me, 

that after the secret OMB input is received, there is further opportunity for transparency. It looks like that they get the last bite at 

the apple, don’t they? 

Mr. STEPHENSON. Are you asking me? 

Senator WHITEHOUSE. I am asking Mr. Gulliford. 

Mr. GULLIFORD. I am not familiar with that chart, as I indicated, 

and I would have to examine it to answer that question. I will be 

happy to take that question back and provide the Committee with 

an answer to that. 

Senator WHITEHOUSE. OK. I would appreciate it. Mr. Stephenson? 

Mr. STEPHENSON. The final assessment is shared with the public 

who can then look at the research, but you can’t see what happened in the steps prior to that. You can’t say, the DOD offered a 

new piece of research or something, you can’t see what that was. 

If they had a concern, you don’t know what it was. This is the scientific process. 

The policymaking process is the risk management, when you are 

assigning regulatory approaches. It has no business in this part of 

the process. Now, OMB was saying, we are just coordinating via 

Government agencies the Federal family, as they would put it. 

Senator WHITEHOUSE. But there is nothing that you are aware 

of in the process that limits them to that? I mean, if the worst case 

scenario is that a polluter comes to the White House, makes big 

campaign contributions, agrees to be a pioneer or whatever it is, 

and says that they are going to, you know, but they want OMB to 

put the word in for them through this process, there is nothing in 

the process itself that would ever disclose that or surface that or 

prevent that from happening. 

72 

Mr. STEPHENSON. We have no evidence of that happening. All we 

are saying is that to have complete transparency in the process 

eliminates—— 

Senator WHITEHOUSE. I am not suggesting it has happened, either. But there is nothing about this process that would prevent 

that or disclose it if it happened at this point. 

Mr. STEPHENSON. That is our fear. 

Senator WHITEHOUSE. Yes. Thank you. 

Senator BOXER. Thanks, Senator. 

Let me say that, to Senator Craig, who said this hearing is just 

concerned about process and not outcomes, that is wrong. The outcomes have already been a disaster, because they put this into play 

without it being officially done. They have already put this process 

into play. 

And what has happened is, EPA itself said they should be doing 

100 chemicals, regulating over 100 in 2 years, and they have regulated 4 chemicals. So outcome, yes. We are not seeing the protection of the American people. 

Second, I want to thank GAO from the bottom of my heart for 

doing this for us. This notion that secrecy is going to be built into 

this process, where the American people are the ones who will suffer if the wrong decision is made is a complete outrage. It goes 

against the spirit of this whole Country, which is openness and 

trusting its citizens with information. 

Third, shunting scientists aside and putting in front the political 

folks is so obviously a problem that I can’t believe we are not hearing outcries from my friends on the other side of the aisle who, 

when and if we do get a Democratic President, it will be those folks 

in the room. No one should be in that room in the early risk assessment stages at all except the scientists and the people concerned 

about health. Mr. Stephenson, if you made any point in a passionate way, that is the point. 

There is room for all these other folks as we debate what to do. 

But in the setting of what is safe for our people, it has to be pure, 

done by the people who have no axe to grind, who simply have a 

concern with the science and what it means to the health and safety of our people. 

Look, when I go home I hear all the time the fears of my constituents about what their kids are being exposed to, what their 

pregnant daughters are being exposed to, what should she eat, 

what should she avoid, what is the problem? I wish I could tell 

them that we have had a stellar, we have done a stellar job here. 

We haven’t. It is a nightmare. 

And I will tell you, it is already a nightmare. If this process is 

put into place, it will institutionalize this nightmare and set us up 

for scandal. Because Senator Whitehouse said it as clearly as it 

needed to be said, people are going to be represented around that 

table, and we will never know. And Senator Whitehouse, I want 

you to know, as we struggle to get e-mails back and forth on the 

waiver, we can’t get them. And you know what the answer is from 

the Bush White House? You are not entitled to these, they are 

interagency comments. 

So you know, we weren’t born yesterday. Well, you can tell that 

from looking at me, I was definitely not born yesterday and I do 

73 

understand that this is a secret process, it is a nightmare. And I 

just want to thank our witnesses for making it very clear to us that 

is the case. Thank you very much. 

We will call up our second and final panel. Professor Linda 

Giudice, who is an M.D., a Ph.D., a Chair of Obstetrics, Gynecology 

and Reproductive Sciences at the University of California, San 

Francisco; Annette Gellert, who is the Co-Founder and Chair of the 

WELL Network; V.M. DeLisi, Fanwood Chemical, Inc., Synthetic 

Organic Chemicals Manufacturing Association; Laura Plunkett, 

Ph.D., Integrative Biostrategies, LLC, minority witness; Professor 

Lynn Goldman, she is our pediatrician, Chair of the Program in 

Applied Public Health, Johns Hopkins University, former Clinton 

EPA Assistant Administrator for Pesticides and Toxic Substances. 

Well, those were such long introductions you have time to actually have a seat. So we will go forward, and we will ask Dr. Giudice 

to address us on this. We will give you each 5 minutes and then 

we will have lots of time for questions. 

STATEMENT OF LINDA C. GIUDICE, M.D., PH.D., MSC., PROFESSOR AND CHAIR, DEPARTMENT OF OBSTETRICS, GYNECOLOGY AND REPRODUCTIVE SCIENCES, UNIVERSITY OF 

CALIFORNIA, SAN FRANCISCO 

Dr. GIUDICE. Thank you. Good morning, Chairman Boxer and 

Committee members. Thank you for the opportunity to provide testimony at this important hearing today, where I shall focus on 

three things: one, disturbing trends about male and female reproductive health and development; two, how chemicals in our environment can affect these; and three, preserving health now and for 

future generations. 

During my career as a reproductive endocrinologist and infertility specialist, I have treated thousands of patients with infertility 

and reproductive disorders: young men with abnormal sperm, teens 

into menopause, little girls with puberty at 6 years old and women 

with endometriosis, uterine fibroids, incapacitating pain, infertility 

and miscarriage. We do not know the underlying causes for most 

of these disorders, but increasing scientific evidence suggests that 

environmental contaminants play a role. 

Five years ago, one of my patients questioned whether her exposure to environmental chemicals as a child growing up near a PCBcontaminated site on the East Coast could play a role in her infertility. For me, this was a wake-up call, because we know that hormones can affect human development and some environmental 

chemicals at like hormones. 

There are disturbing trends in the United States. The percentage 

of women in their peak time of fertility, less than 25 years of age, 

who report difficulty in conceiving and maintaining pregnancy, has 

doubled from 4.3 to 8.3 percent between 1982 to 2002. Over the 

past 50 years, sperm counts have decreased by 50 percent in industrialized regions. Compared to 30 years ago, over 25 percent more 

women get breast cancer, 45 percent more men get testicular cancer and 76 percent get proState cancer. Thirty percent more babies 

are born prematurely, and among the most common birth defects 

today are malformations of the male reproductive system. 

74 

Scientific evidence highly suggests that exposures in the womb 

or in early childhood to environmental contaminants can cause in 

humans some of these trends, including birth defects, pre-term 

birth, low birth weight, learning disabilities, childhood cancers and 

later effects as adults, diabetes, obesity, heart disease, infertility 

and cancer. So adult disorders happening because of exposures in 

utero. 

Since World War II, nearly 90,000 chemicals have been produced 

and there is ubiquitous exposure to environmental contaminants in 

our air, water, food, drink, cosmetics, personal care products, pesticides and everyday household products. Exposure to these around 

the time of conception, during pregnancy or infancy can be particularly powerful because these are times of special vulnerability, 

where important developmental changes are taking place. These 

exposures can also affect subsequent generations. 

For example, bisphenol A, a chemical that is in can linings and 

present in nearly every one in the U.S., can have such an effect. 

Dr. Pat Hunt at Washington State showed that female fetuses of 

BPA-exposed pregnant mice had damaged eggs and abnormal chromosomes. Abnormal chromosomes are a leading cause of miscarriage, congenital defects and mental retardation in humans. The 

study also showed the prenatal BPA exposure resulted in damage 

across generations. 

Another example is phthalates, common in personal care and 

vinyl products. Exposure during pregnancy can lower fetal testosterone, a hormone important for male reproductive tract development. In animals, this is linked to undescended testicles and deformed penis at birth. Dr. Shanna Swan has shown that pregnant 

women with higher phthalates have a greater risk of having little 

boys with decreased genital dimensions, supporting effects on the 

male system in the human. 

Exposure to chemicals like these interferes with proper functioning of the endocrine system, raising concern among health care 

providers and scientists, and others include pesticides, solvents and 

heavy metals. So what to do? 

We need to ensure that couples can conceive if they wish and 

have a healthy pregnancy and healthy children and grandchildren. 

We need the Federal Government to fulfill its mission, assemble 

existing scientific knowledge, impartially reviewing it in an unbiased manner following scientific principles free of ideology. For 

some chemicals we have scientific data, but for many, we do not. 

And the absence of data doesn’t mean that a chemical is safe, it 

just means that we have no data. 

For these chemicals, we need actions that require providing sufficient information so our Government can move forward to prevent 

harmful exposure and by acting now, to guarantee the health of 

our children and our grandchildren and generations to come. 

My thanks go to the Society for Women’s Health Research, our 

UCSF Program on Reproductive Health and the Environment, the 

Reproductive Health Technologies Project, and the American Society for Reproductive Medicine, for their help in preparing this testimony. Thank you. 

[The prepared statement of Dr. Giudice follows:] 

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RESPONSES BY HON. JAMES GULLIFORD TO ADDITIONAL QUESTIONS

FROM SENATOR BOXER

Question 1. Dr. Giudice. please describe how sensitive the human reproductive 

and other hormone controlled systems can be to toxic chemicals during periods of 

particular vulnerability, such as pregnancy or when infants are rapidly developing 

in the first few years after birth? 

Response. Critical and sensitive windows occur periconceptually (prior to, during 

and shortly after the fertilization of the egg) and during pregnancy; infancy, childhood and puberty (Woodruff et al. 2008). A critical window of susceptibility is a 

time-sensitive interval during development when exposures to environmental contaminants can disrupt or interfere with the physiology of a cell, tissue or organ 

(Louis In Press; Morford et a!. 2004). It is a period characterized by marked cellular 

proliferation and development and numerous changing metabolic capabilities in the 

developing organism (Calabrese 1986; Louis In Press). Exposures to environmental 

contaminants during this window may result in adverse, permanent and irreversible 

effects that can have lifelong and even intergenerational impacts on health. Researchers have suggested the need to also define sensitive windows of susceptibility. 

Exposures during sensitive windows of susceptibility may still affect development or 

result in eventual adult disease, but with reduced magnitude compared to the effect 

of exposure during the critical window of susceptibility (Ben-Shlomo and Kuh 2002; 

Louis In Press). For example, diethylstilbestrol (DES) exposure reprograms the expression of estrogen responsive genes in Eker rats exposed on post-natal days 3– 

5 or 10–12 (critical window of susceptibility). leading to increased incidence of uterine leiomyoma. In contrast, rats exposed on post-natal days 17–19 (sensitive window 

of susceptibility) did not experience this developmental programming and had a rate 

of uterine leiomyoma that was elevated but not statistically different from control 

animals (Cook et al. 2007). 

THE DES EXAMPLE

Prenatal exposure to DES, a synthetic estrogen and thus an endocrine disrupting 

chemical (EDC), provides an unfortunate example of the influence of exposure to an 

endocrine disrupting compound during a critical window development. DES was 

given to U.S. pregnant women between 1938 and 1971 under the erroneous assumption that it would prevent pregnancy complications. In fact, in utero exposure to 

DES alters the normal programming of gene families, such as Hox and Wnt, that 

play important roles in reproductive tract differentiation (Miller et al. 1998; Pavlova 

et al. 1994; Taylor et al. 1997; Woodruff and Walker In Press). 

As a result, female offspring exposed to DES in utero are at increased risk of clear 

cell adenocarcinoma of the vagina and cervix, structural reproductive tract anomalies, infertility and poor pregnancy outcomes, while male offspring have an increased incidence of genital abnormalities and a possibly increased risk of proState 

and testicular cancer (Schrager and Potter 2004). These observed human effects 

have been confirmed in numerous animal models which have also provided information on the toxic mechanisms of DES. Animal experiments have also predicted 

changes later found in DES-exposed humans. such as oviductal malformations 

(Newbold et al. 1983), increased incidence of uterine fibroids (Baird and Newbold 

2005; Cook et al. 2005; McLachlan et al. 1980) and second— generational effects 

(Newbold et al. 1998, 2000) such as increased menstrual irregularities (TitusErnstoff et al. 2006) and ovarian cancer (Blatt et al. 2003) in DES-granddaughters 

and increased hypospadias in DES-grandsons (Brouwers et a!. 2006; Klip et a!. 

2002). 

DES is but one example of how exposure to EDCs can disrupt developing organ 

systems and cause abnormalities that only appear much later in life or in the subsequent generation (Colborn et al. 1996). Other examples include: prenatal exposure 

to bisphenol a, an estrogenic chemical, in mice resulted in effects on the daughters 

developing eggs (Susiarjo and Hunt In Press), and prenatal exposure to phthalates, 

an anti-androgenic chemical, can result in adverse effects on male reoproductive development such as poor sperm quality and increased incidence of cryptorchidism 

(undescended testis) and hypospadias (abnormal penis development) (Woodruff et at, 

under review). 

Question 2. Dr. Giudice. could you please explain the importance of considering 

human exposures to multiple chemicals on very delicate biological systems. like the 

human endocrine system? 

Humans are exposed daily to a mixture of environmental contaminants in air, 

water and food. In a recent biomonitoring study of over 150 contaminants, the U.S. 

Centers for Disease Control and Prevention (CDC) reported that all 150 chemicals 

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were detected in some portion of the U.S. population and that several of the chemicals, such environmental tobacco smoke, lead, mercury and phthalates, are detected 

in nearly all or all of the population (CDC 2005). These and similar biomonitoring 

efforts improve our understanding of current body burdens of environmental contaminants. With this knowledge comes a need for better science on the health risks 

associated with current patterns of exposure, including increased risks resulting 

from exposures to multiple chemicals. For example, the majority of studies and regulatory focus have been on exposures to individual phthalates, which may underestimate the actual risks. Over 95 percent of the population from ages 6 and to over 

65 years is exposed to at least 5 phthalates on a regular basis (Silva et at 2004). 

Certain phthalates can inhibit testosterone synthesis, thus decreasing testosterone 

levels. Reducing testosterone levels in rats during in utero development can results 

in adverse effects on male reproductive development including decreased sperm 

counts, decreased ano-genital distance, hypospadias, cryptorchidism, and decreased 

size or agenesis of the accessory sex glands (Woodruff et aI., under review). The severity of effects increases with the dose. 

Recent studies show exposure to mixtures of chemicals that can reduce testosterone levels can have dose-additive effects. Rats exposed to a mixture of pesticides 

that can decrease testosterone levels, vinclozolin, procymidone, and f1utamide, at 

doses that would not have caused hypospadias alone, resulted in over 50 percent 

of animals with hypospadias (Christiansen et al. 2008). Another study found prenatal exposure to a mixture of seven phthalates and pesticides produced cumulative, 

dose additive outcomes in the androgen-dependent tissues (Rider et al. 2008). 

A study of the thyroid system has found similar results. A study of a mixture of 

18 thyroid disrupting chemicals (dioxins, dibenzofurans and PCBs) was tested at 

doses comparable to human exposure levels for effects on thyroid hormone levels in 

rats. The mixture had a dose-additive effect on thyroid hormone levels at environmentally relevant doses and a 2–3 fold greater than dose-additive effect at higher 

doses (Crofton et al. 2005). 

The studies show that chemicals acting on the same system can have cumulative 

effects. Assessments considering single chemicals in isolation are therefore likely to 

underestimate the potential effects from real-world exposure to chemical mixtures 

(Woodruff et aI., under review). 

Finally. biomonitoring data indicate that more effort is needed toward approaches 

that identify and mitigate exposure to harmful chemicals prior to measuring these 

contaminants in people. 

Question 3. Dr. Giudice. as a public health professional and scientist. how important is transparency in ensuring a valid and strong scientific process? 

Response. To make informed decisions. it is critical we have the best science available to inform what we know and what we do not know about how environmental 

chemicals can influence health. Science is an iterative process, as scientific inquiry 

moves forward, further insights are gained and new questions arise. Capturing and 

translating the complexities of the science is an ongoing challenge in the regulatory 

and policy arena. While science pursues new areas of inquiry, decision making requires timely answers to questions about risks and hazards to public health in order 

to mitigate future or current potential harm (Woodruff et aI., under review). Regulatory context also requires a different sufficiency of evidence. For example, it is not 

necessary to identify every mechanistic step leading from exposure to outcome to 

make decisions that consider public health. For example, regulatory decisions are 

often made based on evidence that a chemical is ‘‘likely’’ to cause a particular outcome, such as cancer. Transparency is an important part of the scientific process— 

it allows full evaluation of the methods and protocols used from which conclusions 

are drawn. Without transparency, we cannot fully evaluate the findings from studies nor the conclusions, and this limits our ability to make informed decisions. 

Question 4. Dr. Giudice. at the hearing. another witness raised questions about 

some of the data you relied upon in your testimony. Would you please elaborate on 

the scientific information you relied upon in your statements. with citations to the 

literature? 

Response. In the beginning of my testimony, I referred to some concerning trends 

in reproductive health. The sentence and references are below: Compared to 30 

years ago, over 25 percent more women get breast cancer (NCI 2004), over 45 percent more men get testicular cancer (Bray et al. 2006; Sokoloff et al. 2007), and 76 

percent more men get proState cancer (Penson and Chan 2007). 

Senator BOXER. Thank you very much, Doctor. 

Our next majority witness is Annette Gellert, Co-Founder and 

Chair of WELL Network. Welcome. 

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STATEMENT OF ANNETTE GELLERT, CO-FOUNDER, 

CHAIR, WELL NETWORK 

Ms. GELLERT. Good morning, Chairman Boxer, members of the 

Committee. Thank you for this opportunity to testify. 

My name is Annette Gellert. I am a wife and the mother of three 

children. I am a Founder of the WELL Network, which promotes 

green planning, a comprehensive process between industry, government, scientists and informed citizens to solve together environmental health problems. 

I am also Chairman of Resource Renewal Institute, whose Green 

Plan Center researches advanced environmental management 

strategies. 

After a bill was introduced in California concerning biomonitoring, I wanted to know what potentially toxic chemicals might be 

inside my family. My family and I had our blood tested in 2006 by 

the Environmental Working Group to determine possible exposure 

to 70 toxic chemicals. I was alarmed to find out that I had 36 

chemicals in my body and shocked that my 16 year old daughter, 

Heather, had 34 chemicals in hers. There were similar results in 

the rest of the family. Heather has been on the planet for such a 

short time, yet she lives in a much more toxic environment. 

Of the chemicals that were found in our bodies, some have already been restricted in the European Union. These chemicals are 

suspected of being harmful to the thyroid, as well as reproductive 

and neurological systems. I am worried about my children’s health. 

I am worried about my children’s ability to reproduce. I am worried 

about the health of their children, our grandchildren. I am not 

alone. 

I will do everything in my power to protect my children and I am 

here to ask you to do the same. I am a reproductive cancer survivor, cancer of the placenta is what I had. Too many of my friends 

are fighting cancer. While I was preparing for this hearing, I got 

very bad news. My husband, Fred, was diagnosed with bladder 

cancer. We are going through that now. 

A known cause of bladder cancer is industrial chemical exposure. 

No doubt many of you in this room have similar stories. The cancer 

rate keeps going up. 

There is mounting evidence that numerous chemicals in our environment are seen as contributors to illness. Some of them are 

known carcinogens. When my children needed Tylenol in school, it 

required my written permission. When they are exposed to chemicals, it happens without my permission and without my knowledge. 

We come into contact with toxic chemicals all the time, from cosmetics to electronics to cleaning agents to plastic containers to children’s toys to baby bottles and teethers. We are exposed to harmful 

chemicals in every aspect of our lives. We have had no choice in 

our past exposures and continue to have little choice now. 

Only a very small percentage of chemicals have been tested for 

toxicity. We are in a crisis. America needs a new approach, a proven, better way, green planning. The key to progress is building 

trust that promotes cooperation between sectors, Government, industry, science and an informed public. This strategy is working 

very well in other countries, where it has been in action for nearly 

20 years, creating environmental and economic success. 

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And now the EU has introduced REACH, a new integrative 

chemicals policy which is already having an effect, setting the 

terms for global markets and manufacturing and market access. 

We are not scientists or chemists. Our concerns represent millions 

of other women who fear the impact of products we use daily. 

There is virtually no information we can trust on whether products 

are safe or not. We need to make those decisions by ourselves. 

There is no American scientific body that has assessed all chemicals in common use to determine their impact on human health 

and no place to get that information. We are greatly concerned that 

by falling behind other countries’ regulations, the United States 

will become the dumping ground for all the products that cannot 

be sold in Europe. Because their regulations are stricter than ours. 

In the United States, we must prove harm before a product is removed. In Europe, industry must prove safety before a chemical is 

introduced. We urge you to protect us and start this process by 

looking at chemicals in a comprehensive way. It is the right thing 

to do. 

Thank you. 

[The prepared statement of Ms. Gellert follows:] 

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Senator BOXER. Thank you so much for your moving testimony. 

Mr. DeLisi, Fanwood Chemical, Inc., Synthetic Organic Chemical 

Manufacturers Association, minority witness, welcome, sir. 

STATEMENT OF V.M. DeLISI, PRESIDENT, 

FANWOOD CHEMICAL, INC. 

Mr. DELISI. Good morning, Chairman Boxer and distinguished 

members of the Committee. My name is Jim DeLisi, I am President 

of Fanwood Chemical, located in Fanwood, New Jersey, and I 

might add, the proud father of two grown daughters and a grandfather of one. 

I have been employed by Fanwood Chemical for over 30 years, 

and have specialized in the marketing of organic chemical intermediates in North America as well as Europe and South America. 

In addition, I have been heavily involved in trade issues that impact our industry. I have served as chairman of the Synthetic Organic Chemical Manufacturers Association, better known as 

SOCMA’s International Affairs Committee for many years. In addition, I am the Chairman of ITAC 3, the Industry Trade Advisory 

Committee for Chemicals, Pharmaceuticals, Health Science Products and Services administered jointly by the United States Department of Commerce and the United States Office of the Trade 

Representative. 

Thank you for this opportunity to share with you my company’s 

perspective on current chemical risk management regulations and 

initiatives by the U.S. Environmental Protection Agency. My remarks will also address generally significant concerns about Congress moving in the direction of adopting over-reaching regulatory 

schemes, such as Europe’s Registration, Evaluation, Authority and 

Restrictions of Chemicals Program, better known as REACH. 

Fanwood Chemical currently has two full-time employees and 

two part-time employees working from our offices in Fanwood, New 

Jersey. We also have a working relationship with senior members 

of our industry for help on special projects. The products we sell 

are primarily used to make color or are functional additives in lubricating fluids. In these instances, we are responsible for bringing 

to the marketplace products produced in U.S. manufacturing facilities and are backed up by their staffs. 

We are also experts in REACH and the business challenges this 

program presents, with special emphasis on its impact on non-EU 

based companies. This combination of activities has required us to 

have a working knowledge of EPA’s Toxic Substances Control Act, 

the Federal Insecticide, Fungicide, Rodenticide Act and many other 

EPA programs, as well as similar programs in countries where we 

have direct exports. We also are knowledgeable in programs for 

countries where have indirect exports, i.e., our customers export 

our products to those lands. 

Fanwood Chemical was founded by my father, Vince DeLisi, in 

1971. He could have very successfully completed his career in the 

chemical industry without at all ever leaving the shores of the 

United States. However, the primary industry we were serving at 

the time was the manufacturers of dyestuffs, so I clearly could not 

have had a successful career only within the bounds of the United 

States. Therefore, in 1980, we began to do business in the interVerDate Aug 31 2005 08:38 Aug 12, 2014 Jkt 000000 PO 00000 Frm 00120 Fmt 6633 Sfmt 6633 S:\_EPW\DOCS\88900.TXT VERN
117 

national arena, first into Europe. It was a challenge then and continues to be a challenge today to sell U.S.-produced goods internationally because of severe competition we face from all over the 

world. 

Since 1976, thousands of chemicals have been evaluated by the 

U.S. Environmental Protection Agency under the Toxic Substances 

Control Act for potential human health and environmental effects. 

American chemistry has invested and continues to invest significant resources to assure that products we sell meet rigorous regulatory standards and do not present an unreasonable risk to the 

health of the environment. To the contrary, in fact, chemicals produced by SOCMA members daily improve the lives of millions of 

Americans. These chemicals assist the young and the elderly alike, 

helping the healthy to stay well and the sick to recover. Other 

chemicals produced by industry go toward defending our Nation 

against terrorism, enabling American workers to perform their jobs 

safely and transporting millions of travelers across our Nation. We 

are also confident that chemistry will likely be the key to solutions 

to minimize global warming. All of these benefits are made possible 

by the appropriate balance in our existing system of chemical control regulation and the vast commitments of chemical industry resources to product stewardship. 

I urge this Committee to thoughtfully consider whether it is really necessary or wise to adopt a monolithic new regulatory regime 

for chemical regime like the EU’s REACH, Registration, Evaluation, Authorization and Restriction of Chemicals, program. In our 

view, existing EPA regulation and voluntary initiatives are sufficient and far more appropriate than REACH, to control possible 

hazards and still preserve the sustainability of America’s third 

largest manufacturing industry. 

Our industry accepts our responsibility to profitably make products that are safe under expected exposure conditions, an obligation that EPA polices under TSCA. But Congress has also established a policy in TSCA that chemical regulations should not impede unduly or create unnecessary economic barriers to technological innovation. This balance of regulatory burdens and public 

benefit is crucial for small American business which would be hit 

hardest by a REACH-type scheme. 

A common assumption that chemical companies each employ 

thousands of workers and have unlimited resources are myths. Seventy percent of SOCMA members, many of which operate in New 

Jersey, are classified as small business by the Federal Government. 

Though not a manufacturer in the pure definition, Fanwood Chemicals sells chemicals domestically and abroad to manufacturers that 

produce end-use products. Manufacturers large and small rely on 

companies like mine to source chemicals on their behalf, enabling 

them to reliably meet American consumers’ demand for their products. In a major way, Fanwood Chemical and the many small companies like it represent the underpinnings of the industry. Although we are small, our regulatory obligations are very similar—— 

Senator BOXER. Sir, I want you to conclude. 

Mr. DELISI. OK. 

Senator BOXER. Yes. 

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Mr. DELISI. We believe that an American REACH would not only 

hamper innovation but reverse the progress made over the course 

of many years by Federal regulators in the chemical industry. 

Thank you for this opportunity to share with you Fanwood Chemicals’ perspectives on these issues. 

[The prepared statement of Mr. DeLisi follows:] 

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Senator BOXER. Thank you very much. 

Next is Dr. Laura Plunkett, Ph.D., Integrative Biostrategies, 

LLC, a minority witness. Welcome. 

STATEMENT OF LAURA M. PLUNKETT, PH.D., DABT, 

INTEGRATIVE BIOSTRATEGIES, LLC 

Dr. PLUNKETT. Good morning, Madam Chairman and Senators. 

I want to thank you for the opportunity to be here today to speak 

to you. 

My name is Dr. Laura Plunkett. I am a pharmacologist, toxicologist and a human health risk assessor. In my job every day I 

look at these issues related to what chemicals in our environment 

are affecting our health. I work for industry sometimes, but I also 

work for individuals, and often give advice to individuals or work 

on cases where individuals have been harmed by chemicals or by 

individual consumer products. So I can look at this from both perspectives. 

My testimony today is related to the adequacy of current risk assessment methods and regulatory programs to evaluate chemicals 

and identify risks to sensitive populations in the human population. That includes the developing fetus, infants and children. I 

would like to say that this testimony reflects my views, not the 

views of my clients. 

The first thing I want to do is briefly define risk assessment, 

even though a former witness did that for us. Risk assessment is 

a process, a multi-step process within the regulatory environment. 

Risk is defined as the probability that any injury, disease or health 

effect, even something as terrible as death, will occur from contact 

or exposure to a chemical. I am going to limit my comments to 

chemical risk assessment today. 

It is a four-step process involving hazard identification, dose response assessment, exposure assessment and risk characterization. 

Each part of the process is very important in being able to determine whether or not something we are exposed to is truly going to 

harm us. 

There is a large body of published, peer-reviewed scientific literature available that speaks to the adequacy of our current risk 

assessment process that is used by EPA to protect human health. 

The large body of studies and information out there speaks specifically to the health and the protection of the health of sensitive 

human sub-populations, such as the fetus, infants and children. I 

have reviewed and analyzed this large body of information over the 

years I have worked as a consultant, and I would like to speak just 

very briefly to a few of the key points or principles that I think you 

can glean as a scientist looking at this literature. 

The first point, as I think everyone is aware, children are not little adults. Age and stage of development are extremely important 

to risk assessors. We use those things as considerations in our 

process. Children, while not being little adults, their sensitivity to 

chemical exposure is highly dependent on the nature of the chemical. There are chemicals where children are more sensitive and are 

the population of concern for the risk assessment. There are chemicals where in some cases it is a different population, the elderly, 

for example, that may be of most concern. In some cases, children 

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can actually be less sensitive than the mature human adult to the 

exposure to the chemical. 

Age is not the only factor that contributes to differences among 

humans in the response to chemical exposures. Gender, genetics 

and health status are also very important, and in some cases, more 

important than the age. Exposure, however, is one of the most critical components in the process. We know that there are a lot of 

data showing that children can be exposed to a greater extent to 

chemicals in their environment, due to things that they do daily in 

their environment. All of those things are currently employed and 

used as part of the risk assessment process. We do children-focused 

or child-focused parts of our assessment when a child is the receptor or the individual that is of concern to the risk assessment. 

If you do an analysis and look at the studies overall, and try to 

do what I call a weight of the evidence approach to examining the 

published literature, you can see that the methods that EPA currently uses for its risk assessment indeed give a risk assessor some 

confidence that the developing fetus, infants and children are being 

protected. Remember that the methods we are looking at include 

consideration of differential sensitivity, not only to toxicity, but also 

on the exposure side. 

Current risk assessment methods for chemicals employ tieredtesting strategies as a common thing that we see today. That is 

what the current regulations use. They allow the risk assessor to 

look at the fact that resources are being focused on evaluation of 

the chemicals of most concern and also looking at the population 

of most concern. They allow you to prioritize the chemicals for further testing. That is an important part of the process. 

So when I look at this data and also the regulations that are currently in place, as a scientist, I believe that we can have some confidence that we are protecting the fetus, infants and children with 

the approaches that are currently in place. 

This fact, combined with the fact that we know that hazard is 

not the only part of the equation, but also we need to know something about the exposure and the overall risk of the chemical that 

we look at, that is an important part of the equation is well. 

Enforcing a chemical regulation is also a focus. I think that is 

part of the process. When you look at TSCA, if enforcement is done 

as can be done, indeed I think that the chemical regulatory process 

can be complete and protective of human health for all sub-populations. 

I have a few seconds and I just wanted to make a couple of comments to some of the things that I have heard before. 

Senator BOXER. Actually, you have gone over. You have gone 31 

seconds over, but if you want you can go another 30 seconds. Go 

right ahead. 

Dr. PLUNKETT. I just wanted to say that in some of the comments 

that I have heard, and some of the studies and some of the statistics that have been brought up by the other witnesses, as a scientist, I am not aware that some of those statistics are indeed true. 

I would encourage people on the panel to use—— 

Senator BOXER. What statistics? 

Dr. PLUNKETT. Some of the statistics about the rate of cancer incidence increasing, the level that it has increased over the years. 

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I think if you look at the literature, those numbers, at least the 

numbers that I am aware of are not supported by the scientific literature, at least. I will end it there. 

[The prepared statement of Dr. Plunkett follows:] 

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RESPONSE BY LAURA M. PLUNKETT TO AN ADDITIONAL QUESTION

FROM SENATOR BOXER

Question. Plunkety during the hearing, you stated that, ‘‘as a scientist, I am not 

aware that some of those statistics are indeed true. ‘‘ When I asked you which statistics. you answered, ‘‘Some of the statistics about the rate of cancer incidence increasing, the level that it has increased over the years. I think if you look at the 

literature. those numbers. at least the numbers that I am aware of are not supported by the scientific literature, at least. ‘‘ Please answer the following questions 

concerning your statement: 

Did you know that the National Cancer Institute. which is part of the US National Institutes ofHealth. states: ‘‘Over the past 20 years. there has been some increase in the incidence of children diagnosed with all forms of invasive cancer. from 

J1.5 cases per 100,000 children in 1975 to 14.8 per 100,000 children in 2004.′′ 

Did you know that the America Cancer Society, which has funded $3 billion in 

cancer research—including funding the work of 42 Noble Prize winners—estimates 

that ‘‘[s]ince the early 1970’s, incidence rates of... (non-Hodgkin lymphoma) have 

nearly doubled. ’’ 

Response. Senator Boxer, I am aware of the sources you have listed above and 

in fact they are some ofthesamesourcesIreferredtoinmyletter ofMay 

1,2008toSenatorInhofewhereI suggested that statistics for cancer incidence can be 

found in some reliable data bases such as the NCI. In that letter. I mentioned two 

documents that provide summaries of trends in cancer incidence over time available 

from NCI (e.g., Ries, L.A.G. et al. (eds). SEER Cancer Statistics Review, 1975–2005. 

National Cancer Institute. Bethesda. MD. http://seer.cancer.gov/csr/1975—2005/, 

based on November 2007 SEER data submission, posted to the SEER web site, 

2008; Ries, L.A.G. et al. (eds). Cancer Incidence and Survival among Children and 

Adolescents: United States SEER Program 1975–1995, National Cancer Institute, 

SEER Program. NIH Pub. No. 99–4649. Bethesda. MD, 1999). 

As I stated, both of these documents are reliable, authoritative sources accessed 

by scientists when wanting to understand trends in cancer incidence in the U.S. I 

believe that review of these two documents reveals that the statistics cited at the 

hearing on April 29th are not supported by the NCI data. In general. cancer incidence overall has remained somewhat stable over the last 30 years, with some regional. age group. and racial variations. I would refer anyone interested in citing 

a cancer incidence rate to those sources. with one document specific to childhood 

cancers. I also believe that these two documents would be good resources for the 

Committee as they try to understand the incidence of cancer. As I do not know 

where your statistics above are actually derived from, as you have not provided me 

with the citations in your question above, I cannot respond specifically to your values. I would again reiterate, however, that the NCI indicate that the overall incidence of cancer has remained somewhat stable and that any trends in certain regional or age group statistics must be carefully considered in light of Ms. Heather 

Majors September 2, 2008 confounding factors such as changes in diagnostic criteria 

or screening? factors that often are responsible for purported increases. 

RESPONSE BY LAURA M. PLUNKETT TO AN ADDITIONAL QUESTION

FROM SENATOR INHOFE

Question. Dr. Plunkett, there appeared to be some confusion during the hearing 

about a comment you made about the ‘‘rate of cancer incidence increasing’’. I believe 

you stated: 

‘‘Some of the statistics about the rate of cancer incidence increasing, the level that 

it has increased over the years. I think if you look at the literature, those numbers, 

at least the numbers that I am aware of are not supported by the scientific literature, at least. I will end it there. ‘‘ I believe you were making the point that the 

rate of increase may not be as great as others suggested, not that the rate was decreasing. Is this correct and please elaborate. 

Response. Senator Inhofe, you are correct in your suggestion above regarding my 

statements. During the hearing it was erroneously asserted that I had testified that 

cancer rates in the U.S. are decreasing. What I was actually addressing in my testimony and answers to questions was the need to assure that any statistics on disease 

incidence that were presented at the hearing be based on sound science and not 

merely statements made for impact without a basis in actual scientific data. During 

the hearing I was concerned and raised questions when I heard statistics being 

mentioned that based on my experience, were not reflective of the actual incidences 

of cancer and the changes in sperm count in the U.S. 

151 

It is important to realize that data on something such as cancer incidence are 

complex. Statistics can be reported based on yearly incidence, incidence over time, 

incidence broken out by sex, age at diagnosis, mortality, etc. A scientist must consider whether any statistics collected are representative of the population of concern. The best source of such data for describing the U.S. population would be data 

collected in the U.S. Such an authoritative source would be the National Cancer Institute (NCI), which is a part of the National Institutes of Health, Department of 

Health and Human Services. Although I have not had time to do an exhaustive 

search of all the data available, there are several summaries of trends in cancer incidence over time available from NCI (e.g. Ries, L.A.G. et al. (eds). SEER Cancer 

Statistics Review, 1975–2005, National Cancer Institute. Bethesda, MD, http:// 

seer.cancer.gov/csr/1975—2005/, based on November 2007 SEER data submission, 

posted to the SEER web site, 2008; Ries, L.A.G. et al. (eds). 

Cancer Incidence and Survival among Children and Adolescents: United States 

SEER Program 1975–1995, National Cancer Institute, SEER Program. NIH Pub. 

No. 99—4649. Bethesda, MD, 1999). Both of these documents are reliable, authoritative sources accessed by scientists when wanting to understand trends in cancer 

incidence in the U.S. Review of these two documents reveals that the statistics cited 

at the hearing on April 29th are not supported by the NCI data. In general, cancer 

incidence overall has remained somewhat stable over the last 30 years, with some 

regional, age group, and racial variations. I would refer anyone interested in citing 

a cancer incidence rate to those sources, with one document specific to childhood 

cancers. 

With respect to sperm counts in the U.S., there is no one source of data that I 

can point to for reference. However, one authoritative source, the World Health Organization International Program for Chemical Safety (WHO/IPCS), did perform a 

comprehensive review of the issue of endocrine disruption (including sperm count 

issues) in 2002 (IPCS. 2002. Global assessment of the state-of-the-science of endocrine disruptors. Geneva: World Health Organization). The WHOIIPCS concluded 

that with respect to the hypothesis that there may be a global reduction in human 

semen quality (including sperm count) that might be related to environmental exposures to chemicals acting as endocrine active substances, there is not a global trend 

for declining semen quality that can be identified based on considering all of the 

available data. They found that although some studies showed declines in certain 

regions or cities, other studies found no evidence of such decline, suggesting there 

may be regional trends but not a global trend. Therefore, this authoritative source 

does not support the statistic quoted in the hearing related to sperm count declines. 

As I also stated in my previous letter, I strongly believe that science should not 

be used as a political tool to support one position or another, but should be used 

as part sofa decision making process. In this case, it is not sound science to use statistics that are not reflective of the appropriate population, or are reflective of only 

one study when there is body of evidence to consider. 

Senator BOXER. We will get—it depends on the type of cancer, 

but we will get that information into, we will go to the Cancer Institute doctor and we will put those in the record. So wherever that 

will fall. 

Dr. Lynn Goldman, we welcome you, M.D., Chair, Program and 

Applied Public Health at Johns Hopkins, former Clinton EPA Assistant Administrator for Pesticides and Toxic Substances. Also a 

pediatrician, I understand. We welcome you, a majority witness. Go 

right ahead. 

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

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

Dr. GOLDMAN. Chairman Boxer and members of the Committee, 

I really appreciate your interest in this issue. I think that the regulation of chemicals by EPA is a very important area. 

In 1976, when the Toxic Substances Control Act was passed, 

there were great hopes by Congress for what it might do. Unfortunately now, 32 years later, one must acknowledge that this Act 

needs to be revised, in particular, to protect children. Chairman 

152 

Boxer, I know that you have had a major role in legislation to protect the health of children. Your colleague, Senator Lautenberg, 

talked about the Kids Safe Chemical Act, which I think has been 

a wonderful effort. 

I understand, as a former regulator of the chemical industry, the 

way that chemicals play a vital role in the economy. They are very 

important in our society and I would not underestimate that. But 

I think I also understand that strong regulation is needed to assure 

the health of all our citizens, especially our children. 

Today I am here to address the concerns about EPA’s IRIS program. What is this program about? It was mentioned earlier that 

the dose makes the poison. What IRIS is about is establishing what 

that dose is that makes the poison, so that everybody in society, 

whether it is regulators, doctors, States, industry, will know what 

EPA’s views are about that does. I don’t think any of us here today 

are saying that any level of exposure to any chemical is of concern. 

We want to know what the levels that are safe and what levels are 

of concern. That is what IRIS is all about. 

I have been studying formaldehyde, and I think it is an example 

that helps to understand about why this is important. You know 

that formaldehyde is used extensively in the manufacture of wood 

and wood products. For many years, it has been considered to be 

a probable human carcinogen. But in 2006, IARC, the International 

Agency for Research and Cancer, made a determination that formaldehyde is known to cause cancer in humans, does actually cause 

cancer in humans. This is a very difficult threshold of evidence to 

meet for any chemical. 

And the truth is that nearly everybody but the United States has 

taken strong regulatory action on formaldehyde. The State of California, the European Union, Australia, Canada and Japan have 

mandatory standards that are several fold stronger than the U.S. 

Government’s voluntary standards for formaldehyde in wood products. 

Since 1997, the EPA has been trying to reassess formaldehyde. 

In 2004, this process was brought to a halt. Basically, EPA’s political leadership was convinced that new science was right around 

the corner and they should delay a new IRIS listing for formaldehyde. At the same time, the Chemical Industry Institute of Toxicology, the CIIT, published its own risk assessment, which would 

say that formaldehyde standards should actually be weakened and 

not strengthened. 

It was fairly unprecedented. In 2004, when EPA’s Air Office 

issued its new hazardous air pollutant standard for formaldehyde, 

it actually incorporated the CIIT assessment without any concurrence from EPA’s scientists or from EPA’s science advisory board. 

Now, I should say that rule was struck down in 2007 for procedural 

problems, other problems with the rule. But I think that this shows 

how, even in EPA’s actions, this lack of progress with IRIS has 

been a problem. 

Then in 2005, Hurricanes Katrina and Rita flooded the Gulf 

Coast, and as you know, FEMA provided 120,000 travel trailers to 

the victims of those storms to serve as temporary housing. Unfortunately, these trailers contained unacceptable levels of formaldehyde. I think the story is very familiar to all of you, including the 

153 

slow response by the Federal Government, the tragic consequences 

to the people who were living in those trailers, all of which in my 

view would have been unnecessary if EPA had done the right thing 

in the first place in terms of moving forward an appropriate scientific assessment. 

My point is that when you suppress this kind of information 

about what is the dose that makes the poison, there are serious 

consequences. We need to have an EPA whose scientists are free 

to communicate to us about risks. That is very, very important. 

When they are not free to do so, when there are impediments, 

when they are held hostage to these processes that go on interminably, the public’s health does and will suffer. 

It is a complex and challenging process to do these IRIS reviews. 

It is also difficult to peer review these. The process of peer review 

needs to be done—— 

Senator BOXER. You will have to conclude. 

Dr. GOLDMAN. I will. It needs to be done in a scientific process 

and not through a process that is basically an invitation to back 

door involvement by parties who might be affected by the scientific 

assessment. I think that is what we have here. 

Thank you very much. 

[The prepared statement of Dr. Goldman follows:] 

154 


88900.106
155 


88900.107
156 


88900.108
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88900.109
158 

Senator BOXER. I think that is the nub of what we have here. 

Thank you. 

Here is what we are going to do. I am going to give Senator 

Whitehouse and Senator Barrasso 7 minutes each to ask their final 

questions and sum up, and then I will take my turn and then we 

certainly thank this panel and the one before. This has been a very 

important hearing. 

Senator, 7 minutes, please. 

Senator WHITEHOUSE. Thank you very, very much, Chairman. 

Let me start by asking Dr. Goldman about the, you described it 

as a back door process or a back door that the IRIS program creates in the process for influence by people who aren’t proper scientists. I agree that it appears to deliberately create a vector for 

political interference. To what extent it will be used or not is open, 

but epidemiologically, you don’t want to create that kind of vector, 

if you can, even in a political environment. 

But in response to that, Mr. Gulliford suggested that OMB had 

scientists on staff and that raised the implication that what is happening here with OMB is that they are adding to the science 

knowledge that EPA possesses. Based on your experience, how 

would you rate the scientific, particularly the science of chemistry, 

knowledge that is contained within OMB compared to that is contained within EPA with respect to the chemical process and its approval for use around humans? 

Dr. GOLDMAN. For any one chemical, it is difficult to construct 

a panel of scientists who are qualified to peer review an assessment like the IRIS assessment. I cannot think of a single small 

group of scientists who are qualified to peer review each and every 

one of those, in addition to all the other science that the scientists 

at OMB supposedly are reviewing. No matter how good they are, 

it is not possible for them to have the depth and the breadth that 

you need to do that kind of review. 

How you add value through peer review is through something 

like the Science Advisory Board that EPA already has, which, by 

the way, is done out in the open. Those reviews are in the sunshine. Anybody can come and contribute, industry can contribute, 

others can come and contribute. And their arguments are considered on the merits, in terms of the science they are presenting. It 

is not political science. This is about science and the science advisory board process is the best way to accomplish that. 

Senator WHITEHOUSE. Are you comfortable with the IRIS process 

as proposed at all? 

Dr. GOLDMAN. Not at all. And I am very disturbed by the GAO 

report and seeing that EPA has increased the resources for that 

program fivefold over the last several years, with what looks to me 

to be about a four to fivefold decline in productivity. And now they 

are proposing to put more bells and whistles on the process. If 

nothing else, it is just poor management. There is very little output. More than half of the listings are out of date. And this is information that everybody needs, including industry. 

Senator WHITEHOUSE. You mentioned formaldehyde, which is of 

particular interest. The Chairman knows very well my wife, I am 

a very over-married human. And as she well knows, my wife is a 

trained scientist. As a result of her education and the work she did 

159 

as a marine biologist, she has had substantial exposure to formaldehyde. So that is, you ring a bell with me when you talk about 

formaldehyde. 

As I understood it, you said that the EPA began its process to 

evaluate the carcinogenic effects of formaldehyde back in 1997. And 

it wasn’t until 2004 that the process was closed to completion. It 

was then derailed by a finding, I guess by the Administrator himself, that there was new science around the corner. 

Was there any new science around the corner, or was he just 

waiting for the CIIT assessment? Was there, in the world of this 

science, was there some sort of tectonic shift that took place? Was 

there a new development that emerged? 

Dr. GOLDMAN. Nothing has emerged since then. You are married 

to a scientist, so you know there is always new science around the 

corner. What one has to be committed to is periodic reevaluation, 

so that new science is incorporated. But no, nothing new has 

emerged since 2004, nothing. 

Senator WHITEHOUSE. And then you said it was struck down in 

2007. Struck down by courts? 

Dr. GOLDMAN. The rule was struck down, but not because of the 

risk assessment, but because of other things, such as some of the 

exemptions they tried to include. 

Senator WHITEHOUSE. The Chairman has hosted hearings on the 

EPA batting record in the courts of this Country with their theories 

of why various anti-environmental policies should stand up. But 

here we go again. So as I summarize it, here we are in 2008. They 

started in 1997. Because of all this various folderol, we are effectively no place right now with respect to formaldehyde. How would 

you describe where we are in the process right now with respect 

to making a conclusion as to whether it is carcinogenic and what 

steps should be taken to protect public health? 

Dr. GOLDMAN. I think we have to rely on the international assessment that came forth from IARC in 2004. We still don’t have 

a voice from EPA on this. As far as I can tell, we are going to wait 

a long time before we will hear from EPA unless something is done 

to change this process. 

Senator WHITEHOUSE. Thank you. 

Dr. Giudice, I would like to give you the opportunity to respond 

to Dr. Plunkett, who suggested in her testimony that the statistics 

that you shared with us were not supported by data. Just based 

on your resume, as the professor, indeed, Chair of the Department 

of Obstetrics, Gynecology and Reproductive Sciences at the University of California in San Francisco, I am not inclined to believe that 

you have made up statistics here in testimony before a Senate 

Committee. But I would like to give you the chance to buttress 

your assertions in light of her comments. 

Dr. GIUDICE. Thank you. I appreciate that opportunity. 

There is a reference by Bray and colleagues at the International 

Journal of Cancer in 2006, volume 118, pages 3099 on trends in 

testicular cancer incidence. This is very recent and I would suggest 

that our colleagues look at that particular article. 

I am happy to provide the Committee with the written references 

for the other statistics that I quoted. Thank you. 

Senator WHITEHOUSE. Madam Chair, thank you very much. 

160 

Senator BOXER. Thank you. 

Before I call on my colleague, I want to put two things in the 

record, or three things. First, letters from more than 50 national, 

State and local public health and environmental organizations expressing their opposition to the new interagency policy on IRIS, 

and also I am putting in, if there is no objection, recent news reports on this issue. Then second, Senator Whitehouse before you 

leave, this is in reference to your question and also the assertion 

by Dr. Plunkett that cancer is going down. 

How have childhood cancer incidence and survival rates changed 

over the years, National Cancer Institute, an increase over the past 

20 years of children diagnosed with all forms of invasive cancer, 

from 11.5 cases per 100,000 in 1975 to 14.8 cases per 100,000 children in 2004. And finally, also from the Cancer Institute, 

lymphoma, an estimated 74,000 new cases of lymphoma will occur 

in 2008. Since the early 1970’s incidence rate for non-Hodgkins 

lymphoma has doubled. Just wanted you to know that before you 

left. 

[The referenced material was not received at the time of print.] 

Senator BOXER. Senator. 

Senator BARRASSO. Thank you very much, Madam Chairman. I 

have two documents I would also like to read into the record, if I 

could, one from Synthetic Organic Chemical Manufacturers Association and another from the National Petrochemical Refiners Association. 

Senator BOXER. Without objection, Senator. 

[The referenced materialwas not received at the time of print.] 

Senator BARRASSO. Thank you. 

Ms. Gellert, I appreciate your comments and your testimony as 

you are a cancer survivor, with placental cancer. My wife is a cancer survivor of breast cancer, which is obviously much more common, one in eight women, than placental cancer. Dr. Giudice, you 

are the professor. Placental cancer is fairly rare, isn’t it? 

Dr. GIUDICE. Placental cancer is very rare, yes. It is much more 

common in Asia than it is in the United States. And the prevalence 

here I believe is something like 1 in 10,000 to 15,000. 

Senator BARRASSO. I think it is Taiwan with the greatest prevalence that I have studied, is it thought to be environmental in Taiwan? 

Dr. GIUDICE. It is unclear what the etiology is. 

Senator BARRASSO. All right. I was curious how that all came 

about. Thank you. 

I notice that the two of you work pretty closely together. You are 

on the board of advisors of the UC San Francisco Medical center— 

no? All right. Then I must have a different Annette Gellert that is 

listed for the WELL Network. 

Ms. GELLERT. I am a previous board member of the Obstetrics 

and Gynecology Research and Education Foundation at UCSF. 

That was a previous position. I am not currently on that board. 

Senator BARRASSO. You are currently off the board. 

Ms. GELLERT. I actually came to know about that board when I 

was at UCSF getting treated for the molar pregnancy that I had. 

My point was that I really, I don’t know what caused it. I want to 

161 

know what caused it. I want to know, I want more information so 

that I can, I want to know about my husband, too. 

Senator BARRASSO. With his bladder cancer? My best thoughts 

are with him. 

Ms. GELLERT. Yes. The known cause of that is industrial chemicals from every source that I could find. 

Senator BARRASSO. And other causes, there are other—— 

Ms. GELLERT. Well, smoking, and he has never smoked a day in 

his life. Two risk factors are mentioned, one is smoking and the 

other is industrial chemicals. 

Senator BARRASSO. OK. And then I understand, Doctor, that you 

are also an honorary board member of WELL Network? 

Dr. GIUDICE. I am. I just became, and when Ms. Gellert was on 

the OB/GYN Foundation Board at UCSF, this is close to 20 years 

ago, and I joined UCSF two and a half years ago. 

Senator BARRASSO. Thank you. 

Dr. Plunkett, I think we had kind of a back and forth, people responding to differences. Are there additional amounts of my time 

you would like to use to help clarify some of these matters? 

Dr. PLUNKETT. I just wanted to State that I am not asserting 

that cancer rates are going down. What I was trying to comment 

on was the fact that actually, I heard Ms. Gellert mention some 

statistics on rates and incidence. I had not, I am not aware of those 

particular numbers. I am concerned because I think there is a perception of the lay person and the public, and there is information 

out there that the scientists are aware of, and maybe we as scientists need to be better at getting that information out, so that 

the public is aware of what the real risks are, and what true incidence rates, what is the real incidence rate, how do you calculate 

it, how do you determine it, versus the numbers that may get 

thrown around in the popular press. That is all. That is really what 

my comment was about. 

I am not aware of the data that would support some of the numbers that were coming out. Certainly if there is such data, I would 

love to see it. I am just not aware of it. I am also not aware of the 

fact that the incidence rates have been going up to the level that 

has been asserted. That was the comment or the position I was trying to take. 

Senator BARRASSO. You said in your testimony that the EPA currently has in place some methods for considering infants and children as separate exposed populations, apart from adults, allowing 

a risk assessment to consider and account for differences in exposure patterns. Could you elaborate a little bit on that? 

Dr. PLUNKETT. Yes. In the current methods that are used, where 

you do a risk assessment, you are looking at all the potential populations that can be contacted or exposed to the product. And if you 

have a product or chemical where you are worried about child exposure, such as if you had an infant, a bottle for an infant or you had 

some other product that the child might be contacting routinely, 

you can do child-specific exposure assessment on that. In addition 

to that, in the toxicity evaluation part of the risk assessment, for 

many, many chemicals you have data that has been collected in developing animals, reproductive and developmental toxicity studies, 

162 

where you actually can assess what were the direct effects on a developing organism from exposure to that chemical. 

I know there are many chemicals that may not have that kind 

of data. But most of the ones we are talking about that have been 

raised at issue in this hearing, as I have heard it, are ones where 

that data is available. 

Senator BARRASSO. Mr. DeLisi, you talked about the program in 

Europe, the REACH program. Is there a lot of hazard and exposure 

data available that has been gathered from that on different chemicals already? 

Mr. DELISI. Nothing has been gathered yet. The pre-registration 

period starts on the 1st of June, then you have until 2010 for more 

than a thousand tons a year of commerce and 2013 for a hundred 

to a thousand and then 2018 for less than a hundred tons. 

Senator BARRASSO. If we don’t have any data yet from that 

REACH program, is it right to make comparisons between TSCA 

and the REACH program? 

Mr. DELISI. I don’t know how that would be possible. 

Senator BARRASSO. I want to ask about some potential, Mr. 

DeLisi, in making the change in TSCA so that it shifts the burden 

of proving safety from the EPA to manufacturers. Would you recommend shifting that burden and how will that affect a manufacturer’s ability to meet its needs of customers? 

Senator BARRASSO. The burden needs to continue as it is, which 

is really shared. I was at a REACH conference last week, because 

REACH does talk about banning products, and frankly, the thing 

that most startled me was a representative of Rolls Royce trying 

to figure out how they could make a jet engine altogether without 

the use of nickel compounds, which could potentially occur in the 

EU, that nickel compounds would be banned. He literally said that, 

we can’t figure out how to keep a jet engine together without the 

use of those kinds of materials. 

Senator BARRASSO. Thank you, Madam Chairman. 

Senator BOXER. Well, we are going to close this panel out, and 

we have a few comments, a couple of questions. 

This has been a really important and far-reaching hearing. I 

want to thank each and every one of you. I think it has been good 

to have both sides on this panel. And frankly, on the other panel 

as well, the GAO saying that they investigated the EPA and found 

out politics is taking over the program, and EPA saying, oh, no, 

nothing could be further from the truth. Well, let’s let the public 

judge and let’s let my colleagues judge. 

But let me tell you what is going to happen, Mr. DeLisi and Dr. 

Plunkett, Ph.D. If we don’t see action out of the EPA on listing 

these harmful chemicals, not only listing them but regulating 

them, Congress is going to do it. Senator Feinstein offered an 

amendment with me to ban phthalates. It passed overwhelmingly. 

You can see where Senate Whitehouse is coming from on formaldehyde. 

So don’t think because you may be looking at this process, the 

weaker it gets, the stronger we are going to get. Because no Senator in the light of day, I shouldn’t say no, most will not be able 

to take the heat of these dangerous chemicals. People are not stupid, they are smart, they understand, they see what is happening 

163 

to their families. No one can tell them what is happening to their 

families, because they see it. 

So no one can say, oh, it is safe and cancer is going down or 

whatever you said, I am checking on your words. The fact is, we 

know the facts. Childhood cancer, up. I mean, it is a fact. 

So I just want to thank the doctors on the panel, the medical doctors on the panel. You took an oath to do no harm. And what you 

are doing through your work, your active work, which I praise so 

much, what you are doing is making sure that we are not harmed. 

And what is so intriguing about this hearing is that there are 

several issues raised, which is what we wanted. One is the current 

system, the way we regulate chemicals now and how it has failed 

us and how they have come up with four decisions when they were 

supposed to come with a hundred in the last 2 years. 

So it has failed us, because the Administration has informally 

put into place the change in the IRIS program where they are allowing people to sit around a table secretly and give their views. 

And they have tainted and corrupted, and I use my words advisedly, they have corrupted the process of risk assessment. And the 

point is, it is not going to work, because the people won’t allow it 

to happen. 

And you know, we met with a chemical company the other day 

who said that they are, and I am going to just tell you what happened, and I will direct this to Mr. DeLisi. We met with a chemical 

company that said they have invented substitutes for toxic chemicals, such as insulation without formaldehyde. And without strong 

regulations on the chemicals that present a risk, there is not a 

strong market for the safer product. 

So would you agree that sometimes regulation will spur invention, the genius of America, which is what Annette Gellert talked 

about, working with the private sector? Why is it my colleagues on 

the other side paint this picture of, every time we want to help the 

people of America get safer, oh, we are going to hurt the economy? 

That has never been true with environmental regulation. Never. 

We have had green industries, we have had green jobs. This is the 

scare tactics. So people get sick and they die and oh, we can’t do 

anything about it, because it is going to hurt people’s jobs. Well, 

you know, if you are really sick and you can’t breathe, you can’t 

come to work. Pretty basic. 

So Mr. DeLisi, I want to ask you, don’t you think that when 

there is reasonable regulation that it presents an opportunity for 

business to come up with a safer product that you could then export to Europe, where there is obviously going to be a huge market 

for greener products? What do you think? 

Mr. DELISI. Senator, unfortunately, I think it is a two-edged 

sword. My Senator, Frank Lautenberg, this morning mentioned 

DDT. DDT is still in use in sub-Saharan Africa and lots of places, 

protecting people from the ravages of the mosquito-borne diseases. 

I would not want to be a regulator—— 

Senator BOXER. OK, I am not asking you about DDT, because I 

know that story is always brought up. I am asking you about this 

man who came in from a chemical company and said they are 

ready to roll with a substitute for formaldehyde. I am asking you, 

164 

yes or no, is there ever a case where reasonable regulation will lead 

to better, safer products? Yes or no? 

Mr. DELISI. It can. 

Senator BOXER. Good. 

Mr. DELISI. But if the cost of that insulation that he is producing 

is so large that nobody can afford it, that is a down, that is a problem for the consumers. 

Senator BOXER. Yes. But if I told you that your kid being exposed 

to certain levels of formaldehyde is going to get lung cancer, that 

the chances are, it is a very good chance, don’t you think that is 

something we ought to move on and allow these substitutes? Don’t 

you think that people in the Katrina housing there deserve to have 

accommodations that were free of formaldehyde? Don’t you think? 

Mr. DELISI. I am not an expert in formaldehyde, but if that has 

been proven, absolutely. 

Senator BOXER. Good. Well, we are working on it, here, we are 

getting there. I love agreement. 

Well, let me just say, again, do we have this? OK. All right. So 

we are going to put a lot of studies in the record, we will leave the 

record open for a week. And in summing up, here is where I think 

we are. We have an IRIS process that is the basis for many of our 

various environmental laws. That is how they, the Clean Water 

Act, the Safe Drinking Act, the Superfund, TSCA, they rely on— 

did I leave anything out?—Clean Air Act, they rely on the IRIS 

program. So IRIS cuts across. 

Now, we know the IRIS project has been corrupted. And the reason we know it is the GAO did an investigation and they are telling us that already, even without the new system in place, in effect, everything has basically stopped. And instead of listing and 

regulating 100, not listing, scratch that, instead of regulating 100 

chemicals over 2 years, they have regulated four. So we are in a 

crisis. Annette Gellert was right, she used that word. We are in a 

crisis. 

If this goes forward, this process that Mr. Johnson, who refused 

to come here, somebody said no wonder he went to Australia, he 

doesn’t want to sit across from me, I totally get it. But the fact of 

the matter is, he has a responsibility to be here and defend himself 

on this. This is a nightmare. This is a scandal. 

So we now have a circumstance where we are going to see a formalization of a process that puts politics in the center of regulating 

chemicals as Dr. Goldman alluded to, instead of pure science. This 

is a travesty. And it is happening under our noses. 

We are not going to stand for it. Either we are going to change 

things in the election or we are going to start banning these chemicals. Because there isn’t one colleague that I know who is going to 

be able to stand the heat when there is proof about these chemicals. 

Now, I know Dr. Plunkett, you have defended people, your firm 

has, when they are sued, is that right? 

Dr. PLUNKETT. Most of my litigation work currently is in plaintiff’s litigation, actually, not in defense. 

Senator BOXER. OK, so you bring suits against chemical companies? 

165 

Dr. PLUNKETT. I don’t bring suits. I have been an expert witness 

in litigation where suits have been brought against mainly pharmaceutical companies for injuries related to—— 

Senator BOXER. So you have testified for the injured party? 

Dr. PLUNKETT. Yes, I have. 

Senator BOXER. Or for the company? 

Dr. PLUNKETT. For the inured party, in most cases. 

Senator BOXER. You do. So your firm is bent toward making sure 

that people who are injured by chemicals have a right to sue, and 

you come in and you testify on behalf of the injured person, is that 

correct? 

Dr. PLUNKETT. I act as an expert witness, to tell you what I do, 

I act as an expert witness, provide pharmacology and toxicology 

and FDA regulatory testimony related to the risks and hazards 

posed by a drug and whether or not that drug could have caused 

the injury in an individual. 

Senator BOXER. OK, well, I have some confusion, because your 

firm advertises, I have seen the advertising, that you would represent business in defending them. And you are saying you defend 

the plaintiffs, the harmed ones. 

Dr. PLUNKETT. I have worked on both sides. I have also done litigation where I have worked on behalf of industry as well. But in 

expert witnessing, currently in my litigation practice, all of my 

cases are plaintiffs cases at this point in time. 

Senator BOXER. OK, but, this firm—— 

Dr. PLUNKETT. Integrative Biostrategies, yes. 

Senator BOXER. So this is wrong, it says it represents product liability, toxic tort, heavy metals, petrochemicals, pesticides and that 

is, my understanding is that they support the companies. That is 

not right? 

Dr. PLUNKETT. I do work on behalf of chemical companies in risk 

assessment and regulatory issues, yes. 

Senator BOXER. Oh. 

Dr. PLUNKETT. I have also worked on behalf of individual, for example, cities, other entities outside of industry. So I do both of 

those things. 

Senator BOXER. So cities that are sued? 

Dr. PLUNKETT. No. It is not all litigation work. In fact—— 

Senator BOXER. Let’s give an example of a city you have represented. 

Dr. PLUNKETT. For example, I have not represented, I have 

worked on behalf of a small city in Texas where there was a lead 

battery recycling facility located in town, right within the town. I 

worked with the city to help do a blood lead study on whether or 

not the industry was impacting the residents. I designed the study 

and helped implement the study for the city. So in that case, I was 

working on behalf of the children and the families within the city 

to determine whether there was a risk to their health. 

Senator BOXER. Well, good for you. Because then you ought to 

know about childhood cancer rates a little more. 

Dr. PLUNKETT. I—— 

Senator BOXER. Here is the thing. We are dealing with life and 

death here. We have a witness who is experiencing a spouse who 

has bladder cancer. She said the two causes that she has been able 

166 

to learn, because they don’t know why, are smoking, which he 

never did, and exposure to industrial chemicals. We need to find 

out these things. We need to know, frankly. Our Government needs 

to know, so you don’t have to go off to Texas and figure out what 

this, I mean, we ought to have the information of what these batteries do. 

Dr. PLUNKETT. I would agree with you, Senator, that we need to 

know about the chemicals. My only point, the reason I am here 

today is to say that I believe there are risk assessment methods 

currently in place that allow us to determine which chemicals truly 

are risks, based on hazard information which we have, but also exposure and the actual information from the science on the responses in individuals. 

Senator BOXER. Right. And I will tell you, what we have in place 

is the IRIS program. 

Dr. PLUNKETT. We have more than that in place, I would argue. 

Senator BOXER. That is the basic, well, you could argue it. But 

the fact is, every single agency has told us that the IRIS program 

is the program that is the basis for their decisions, OK? So the 

IRIS program is the basis for regulation under the Clean Air, 

Clean Water, and Superfund and all the things that I mentioned 

before. 

So the IRIS, the integrity of that program is at stake here. That 

is why, when the GAO tell us the program is a shadow of its 

former self, now, to get to the issue of REACH is very important. 

Because, Mr. DeLisi, I want you to explain something to me. My 

understanding is a lot of chemical companies do business in Europe. Is that correct, would that be your understanding? 

Mr. DELISI. Yes. 

Senator BOXER. And they will have to conform with REACH, is 

that correct? 

Mr. DELISI. Or they can make a decision to stop doing business 

in Europe. 

Senator BOXER. Exactly. And what do you think people will do? 

Do you think they will walk away? 

Mr. DELISI. Some will. 

Senator BOXER. Well, I would argue they won’t walk away. I will 

argue that they will want to, because this is a global marketplace. 

And with the dollar falling as it is, this is the moment where our 

business are really, at least beginning to see an increase in their 

exports. So I would argue that they would. 

And I would further say, going back to my initial point, that 

when we have this concern, and it is expressed in legislation, you 

are going to have an impetus for these substitutes. Now, you are 

very right, maybe they will cost a little more. I would submit to 

you, if you ask the American people, if you could reduce the rate 

of childhood cancer, we could go into what those cancers are, by 

taking the following steps, having to pay 35 cents more for a solvent, or a dollar more for a different type of cleanser, I would be 

people would be glad to do that. 

So from my perspective, I think it is very shortsighted for business to put their head in the sand and act as if nothing is going 

to change. Because here is my point. If we don’t see a coming together here and I will get back to what Annette Gellert said, which 

167 

is, working together with business and Government and the nonprofit community, if we don’t see that happening, I am just saying, 

colleagues of mine are going to take matters into their own hands 

and you are going to see banning of these chemicals and banning 

of these products. And you will not know what is going to hit you 

next. 

So I think it is in the best interest of business to work with us 

in a way where we do have an open, transparent process here, 

where we don’t have the regulation of a chemical such as formaldehyde get bogged down, as Dr. Goldman said, when we were just 

there at coming up with the regulation, Mr. Johnson pulled it 

down. That is not going to sit well, and you are going to be far 

worse off. You are going to have no certainty because you are going 

to have people going to the floor of the Senate saying, my community, so many people got this type of cancer. And you are going to 

really have more of a problem. 

So I would urge us to work together. I think the message of the 

Wellness Foundation, is it the Foundation? 

Ms. GELLERT. The WELL Network. 

Senator BOXER. The WELL Network. That is a great message. 

We are all in this together. This shouldn’t be one side arguing with 

another. We have everything to gain when we have safe products. 

We have a confident community that won’t start boycotting certain 

products. And I just think do no harm is our first thing we should 

think about, do no harm. But second, make things better. 

I think we ought to look at what Europe is doing. I think we 

ought to realize that it is in the best interest of our businesses to 

learn to work with these restrictions and see how we can have a 

system, frankly, that isn’t different. Because I think that another 

thing Annette Gellert said is right on the mark, we don’t want 

America to be the dumping ground for dangerous products. 

Because here is what is going to happen, I will tell you right 

now, our people will start importing products from Europe in numbers. And by the way, it will be a big business. Somebody will get 

a license, they will bring in these safe products and you will not 

be able to compete because the American people understand that 

some of these chemicals are dangerous. And if they have an opportunity to buy a green product, they are going to do it. 

So I think this could be a win-win for business if we have a little 

bit of a different attitude. Otherwise, you are going to have competition from abroad you never thought you had. I just think that 

is not good for business and it is not good for our people. So this 

has been a heart-felt hearing. I really thank all of you for being 

here, all of you, with your perspectives. I respect all the perspectives, but I think at the end of the day when our people are 

healthy, we are a better Nation for it. 

Thank you very much, and we stand adjourned. 

[Whereupon, at 12:35 p.m., the committee was adjourned.] 

STATEMENT OF HON. BENJAMIN L. CARDIN, U.S. SENATOR

FROM THE STATE OF MARYLAND

Madame Chairman, thank you. 

The mission of the Environmental Protection Agency is to protect human health 

and the environment. The Integrated Risk Information System (IRIS) Program is 

168 

a manifestation of that part of the EPA’s mission which includes the evaluation and 

regulation of toxic chemicals. 

With over 500 chemicals listed, and over 9,000,000 queries to the IRIS data base, 

IRIS is a valuable resource both within the U.S. and around the world in understanding the potential human effects that exposure to the listed chemicals might 

cause. The quantitative information contained in IRIS allows IRIS to be a component in the regulatory process of many states and even other countries. The regard 

with which this data base is held is a tribute to the tireless efforts of EPA scientists 

in evaluating the risks of the listed chemicals. In order to be both useful and credible, the process to list a chemical in the IRIS data base must be unbiased, sciencebased, timely, and transparent. 

In the last few years, despite increases in IRIS personnel, a backlog of IRIS assessments have developed. This backlog is due, in part, to new OMB-managed, 

interagency reviews and due to delays in completion of assessments to await new 

research. 

Earlier this month, the EPA released a revised assessment process for IRIS. This 

revised process concerns me as it will allow far less transparency into the decision 

making process. 

The new assessment process conflates the EPA’s science position on an assessment with the EPA’s science policy position. Assessment findings should inform policy, not be informed by policy. 

Finally, this revised assessment process continues the recent practice of OMB’s 

having a role in the process as well as establishing a new, interagency review process for IRIS. This change potentially compromises the integrity of IRIS by allowing 

those agencies that may have a stake in the EPA’s assessment be able to influence 

that very assessment. 

I am pleased to welcome Dr. Lynn R. Goldman, a professor of environmental 

health at the Johns Hopkins Bloomberg School of Health. Dr. Goldman has served 

as EPA Assistant Administrator for Prevention, Pesticides and Toxic Substances. 

Dr. Goldman’s work in reducing the risk of chemicals and pesticides to the health 

of the public in general, and children in particular, is noteworthy. 

I look forward to hearing Dr. Goldman’s testimony and that of all of the other 

panelists today as we conduct this oversight hearing into EPA’s toxic chemical policies. 

Public health and environmental policy decisions must be rooted in objective scientific assessments. These assessments must be timely and made using the best 

practices possible. 

Thank you Madame Chairman. 

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Æ