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SAFETY OF PHTHALATES AND BISPHENOL-A IN 

EVERYDAY CONSUMER PRODUCTS 

HEARING 

BEFORE THE

SUBCOMMITTEE ON COMMERCE, TRADE, 

AND CONSUMER PROTECTION 

OF THE

COMMITTEE ON ENERGY AND 

COMMERCE 

HOUSE OF REPRESENTATIVES 

ONE HUNDRED TENTH CONGRESS 

SECOND SESSION 

TUESDAY, JUNE 10, 2008 

Serial No. 110–125 

( 

Printed for the use of the Committee on Energy and Commerce 

energycommerce.house.gov 

COMMITTEE ON ENERGY AND COMMERCE 

JOHN D. DINGELL, Michigan, Chairman 

HENRY A. WAXMAN, California 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

FRANK PALLONE, JR., New Jersey 

BART GORDON, Tennessee 

BOBBY L. RUSH, Illinois 

ANNA G. ESHOO, California 

BART STUPAK, Michigan 

ELIOT L. ENGEL, New York 

GENE GREEN, Texas 

DIANA DEGETTE, Colorado 

Vice Chair 

LOIS CAPPS, California 

MIKE DOYLE, Pennsylvania 

JANE HARMAN, California 

TOM ALLEN, Maine 

JAN SCHAKOWSKY, Illinois 

HILDA L. SOLIS, California 

CHARLES A. GONZALEZ, Texas 

JAY INSLEE, Washington 

TAMMY BALDWIN, Wisconsin 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

G.K. BUTTERFIELD, North Carolina 

CHARLIE MELANCON, Louisiana 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

JOE BARTON, Texas 

Ranking Member 

RALPH M. HALL, Texas 

J. DENNIS HASTERT, Illinois 

FRED UPTON, Michigan 

CLIFF STEARNS, Florida 

NATHAN DEAL, Georgia 

ED WHITFIELD, Kentucky 

BARBARA CUBIN, Wyoming 

JOHN SHIMKUS, Illinois 

HEATHER WILSON, New Mexico 

JOHN B. SHADEGG, Arizona 

CHARLES W. ‘‘CHIP’’ PICKERING, 

Mississippi 

VITO FOSSELLA, New York 

ROY BLUNT, Missouri 

STEVE BUYER, Indiana 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

GREG WALDEN, Oregon 

LEE TERRY, Nebraska 

MIKE FERGUSON, New Jersey 

MIKE ROGERS, Michigan 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

TIM MURPHY, Pennsylvania 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

PROFESSIONAL STAFF

DENNIS B. FITZGIBBONS, Chief of Staff 

GREGG A. ROTHSCHILD, Chief Counsel 

SHARON E. DAVIS, Chief Clerk 

DAVID L. CAVICKE, Minority Staff Director 

(II) 

(III) 

SUBCOMMITTEE ON COMMERCE, TRADE, AND CONSUMER PROTECTION

BOBBY L. RUSH, Illinois, Chairman 

JAN SCHAKOWSKY, Illinois 

Vice Chair 

G.K. BUTTERFIELD, North Carolina 

JOHN BARROW, Georgia 

BARON P. HILL, Indiana 

EDWARD J. MARKEY, Massachusetts 

RICK BOUCHER, Virginia 

EDOLPHUS TOWNS, New York 

DIANA DEGETTE, Colorado 

CHARLES A. GONZALEZ, Texas 

MIKE ROSS, Arkansas 

DARLENE HOOLEY, Oregon 

ANTHONY D. WEINER, New York 

JIM MATHESON, Utah 

CHARLIE MELANCON, Louisiana 

JOHN D. DINGELL, Michigan (ex officio) 

ED WHITFIELD, Kentucky 

Ranking Member 

CLIFF STEARNS, Florida, 

CHARLES W. ‘‘CHIP’’ PICKERING, 

Mississippi 

VITO FOSSELLA, New York 

GEORGE RADANOVICH, California 

JOSEPH R. PITTS, Pennsylvania 

MARY BONO MACK, California 

LEE TERRY, Nebraska 

SUE WILKINS MYRICK, North Carolina 

JOHN SULLIVAN, Oklahoma 

MICHAEL C. BURGESS, Texas 

MARSHA BLACKBURN, Tennessee 

JOE BARTON, Texas (ex officio) 

(V) 

C O N T E N T S 

Page 

Hon. Bobby L. Rush, a Representative in Congress from the State of Illinois, 

prepared statement 1 ...........................................................................................

Hon. Jan Schakowsky, a Representative in Congress from the State of Illinois, opening statement ....................................................................................... 1 

Hon. Ed Whitfield, a Representative in Congress from the Commonwealth 

of Kentucky, opening statement ......................................................................... 3 

Hon. Darlene Hooley, a Representative in Congress from the State of Oregon, 

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

Hon. Cliff Stearns, a Representative in Congress from the State of Florida, 

opening statement ................................................................................................ 5 

Hon. Marsha Blackburn, a Representative in Congress from the State of 

Tennessee, opening statement ............................................................................ 6 

Hon. Michael C. Burgess, a Representative in Congress from the State of 

Texas, opening statement .................................................................................... 7 

Hon. Diana DeGette, a Representative in Congress from the State of Colorado, prepared statement .................................................................................... 74 

WITNESSES

Michael A. Babich, Ph.D., Chemist, Consumer Product Safety Commission, 

Bethesda, Maryland ............................................................................................. 9 

Prepared statement .......................................................................................... 11 

Submitted questions 2 ......................................................................................

John R. Bucher, Ph.D., Associate Director, National Toxicology Program, National Institute of Environmental Health Sciences, National Institutes of 

Health ................................................................................................................... 24 

Prepared statement .......................................................................................... 27 

Submitted questions 3 ......................................................................................

Norris Alderson, Ph.D., Associate Commissioner for Science, Food and Drug 

Administration, Department of Health and Human Services, Rockvilled, 

Maryland ............................................................................................................... 34 

Prepared statement .......................................................................................... 36 

Submitted questions 4 ......................................................................................

L. Earl Gray, Jr., Senior Reproductive Biologist and Toxicologist, Reproductive Toxicology Division, Office of Research and Development, Environmental Protection Agency .................................................................................... 48 

Prepared statement .......................................................................................... 50 

Answers to submitted questions ...................................................................... 177 

Marian K. Stanley, M.B.A., Senior Director, American Chemistry Council, 

Arlington, Virginia ............................................................................................... 81 

Prepared statement .......................................................................................... 84 

Submitted questions 5 ......................................................................................

Ted Schettler, M.D., M.P.H., Science Director, Science and Environmental 

Health Network, Ann Arbor, Michigan .............................................................. 115 

Prepared statement .......................................................................................... 118 

Answers to submitted questions ...................................................................... 193 

Calvin Whillhite, Ph.D., State of California, Department of Toxic Substances 

Control, Berkeley, California .............................................................................. 127 

Prepared statement .......................................................................................... 129 

Answers to submitted questions ...................................................................... 205 

Stephen Lester, Science Director, Center for Health, Environment and Justice, Falls Church, Virginia ................................................................................. 152 

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

Answers to submitted questions ...................................................................... 214 

Page

VI 

SUBMITTED MATERIAL

1 Mr. Rush did not submit a prepared statement. 2 Dr. Babich did not answer submitted questions for the record. 3 Dr. Bucher did not answer submitted questions for the record. 4 Dr. Alderson did not answer submitted questions for the record. 5 Ms. Stanley did not answer submitted questions for the record. 

(1) 

SAFETY OF PHTHALATES AND BISPHENOL-A 

IN EVERYDAY CONSUMER PRODUCTS 

TUESDAY, JUNE 10, 2008 

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON COMMERCE, TRADE, AND CONSUMER PROTECTION, COMMITTEE ON ENERGY AND COMMERCE, Washington, DC. 

The subcommittee met, pursuant to call, at 10:08 a.m., in room 

2322 of the Rayburn House Office Building, Hon. Jan Schakowsky 

(vice chair of the subcommittee) presiding. 

Members present: Representatives Schakowsky, Barrow, 

DeGette, Hooley, Melancon, Whitfield, Stearns, Pitts, Terry, Sullivan, Burgess, and Blackburn. 

Staff present: Judy Bailey, Valerie Baron, Andrew Woelfing, 

Consuela Washington, Christian Fjeld, Megan Mann, Lauren 

Bloomberg, Jodi Seth, Chad Girand, Will Carty, and Shannon 

Weinberg. 

Ms. SCHAKOWSKY. The meeting of the Subcommittee on Commerce, Trade, and Consumer Protection will come to order. I will 

begin with my opening statement, but before I do that I would like 

to recognize the absence of our subcommittee chairman, my friend 

and colleague, Representative Bobby Rush. As you all know, Chairman Rush is recuperating in Chicago right now. Although he is not 

here today, he is in regular touch with his staff. He is fully involved in the legislative matters before this subcommittee, and I 

know that he is being ably represented by his staff in his absence. 

On behalf of all the members of this subcommittee, I want to wish 

him a speedy recovery, and we are all looking forward to having 

him back here in this chair. 

At this time, I would like to ask unanimous consent to insert 

Chairman Rush’s testimony in the record. Without objection, so ordered.[The prepared statement of Chairman Rush was unavailable 

at the time of printing.] 

OPENING STATEMENT OF HON. JAN SCHAKOWSKY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF ILLINOIS 

Ms. SCHAKOWSKY. I will now recognize myself for 5 minutes for 

the purpose of an opening statement. We are here today to discuss 

the safety of using phthalates and bisphenol-A in consumer products. Currently, phthalates are used in a wide variety of products 

such as toys, cosmetics, furnishings, footwear, and luggage to make 

plastics softer and more flexible. BPA is used to make plastics 

harder and shatter resistant and can be found in protective gear 

2 

such as helmets, goggles, electronics, pacifiers, shields, and CDs, as 

well as a wide variety of applications not under the jurisdiction of 

the subcommittee such as baby bottles, water bottles, medical devices, and dental sealants. 

There is a wide and sometimes contradictory body of scientific 

evidence regarding the possible harm of using these substances and 

products. While there may be disagreement in the scientific and 

business community about the wisdom of a ban on these substances one thing is very clear: there is widespread and serious 

concern about the safety of these products. Almost a decade ago, 

the 23 member countries of the European Union banned six 

phthalates in all children’s products. In response, Toys‘‘R’’Us, 

Mattel, and Hasbro all soon followed suit and announced that they 

would stop manufacturing children’s toys made with phthalates 

worldwide. Fourteen other countries have joined the EU in banning 

these phthalates as well. 

In America, two particular phthalates, DEHP and DINP, were 

voluntarily removed from infant products such as teethers and soft 

rattles in 1999 after the Consumer Product Safety Commission 

issued an inconclusive study that called for more research into 

their potential hazard. Last year, California became the first state 

in the nation to ban six phthalates from children’s products. In 

April, Washington State became the second state to do so. In Congress, Representative Darlene Hooley, who is with us on the subcommittee, has introduced legislation to ban phthalates in certain 

products, and Senator Diane Feinstein has introduced similar legislation, including an amendment to H.R. 4040, the Consumer Product Safety Modernization Act, which the House passed in December, and which is currently in conference. 

With regard to BPA, in April, 2008, the National Institute of 

Health National Toxicology Program issued a draft report on BPA 

and classified it as a chemical of ‘‘some concern’’ to infants and 

small children. Less than a week later, both Toys‘‘R’’Us and WalMart announced that they would no longer sell baby bottles that 

were made with it. Legislation has been introduced in the Illinois 

state legislature that would ban both BPA and phthalates from 

children’s products, and in Congress the Oversight and Investigations Subcommittee of the Committee on Energy and Commerce 

has begun an investigation into the use and possible harms of 

using BPA. 

A wide range of over 50 children’s health, women’s health, environmental health, and consumer groups have come out in support 

of a ban of most phthalates from children’s products citing ample 

scientific evidence that phthalates may be found in high levels in 

individuals across the country, and that they cause a wide variety 

of adverse health effects in humans. Specifically, these studies 

show that phthalates act as endocrine disrupters which cause potential harm to testosterone development and the male reproductive tract, early onset puberty in girls and thyroid dysfunction. 

Likewise, many advocates believe that BPS may cause detrimental 

effects on sexual development in both men and women and reproductive abnormalities. They are particularly concerned that all of 

these substances may affect infants in their development later in 

life. 

3 

The chemical industry has argued conversely that the use of 

phthalates and BPA in commercial levels is safe. They argue that 

banning phthalates may cause a significant market disruption that 

would leave children and consumers without access to a variety of 

toys and products. They have also raised concerns that banning the 

substances may force manufacturers to use other substances whose 

safety is yet unknown. This hearing will give members of the subcommittee the opportunity to explore the research into the possible 

harmful consequences of exposure to BPA and phthalates to consumer products and to begin to consider what policies thus address 

those potential harms. 

I think we all agree that we need to address the legitimate concerns that are raised when we discuss banning phthalates and 

BPA. Will replacing phthalates with other chemicals lead to other 

unanticipated health risks? Are there alternative chemicals available that we can be confident are safe? Is industry prepared, able, 

and willing to quickly adapt their processes? On the other hand, I 

hope that we can all agree that if these chemicals pose a real 

health risk to children, we must act quickly to remove them from 

our shelves. I have here two rubber duckies. I can’t tell the difference between them. They look and feel almost exactly the same. 

They cost about the same amount of money. One is manufactured 

with phthalates. It is almost 2 percent DNOP and DINP, and one 

without. 

It is easy to see how a child would put either of these in their 

mouths. If we know one is safe, why wouldn’t we remove the possibility of danger from our children’s hands and mouths? As a grandmother, I am concerned that these substances left on the market 

may cause significant harm to our children. I am concerned that 

by not acting quickly, we will make the same mistakes we made 

in the past with lettuce, asbestos, pesticides, tobacco, and expose 

our children to substances which will permanently damage their 

development. I look forward to addressing these issues and other 

questions with our distinguished body of panels here today. I would 

like to welcome all of our witnesses and look forward to hearing 

each of your testimonies. And now I will recognize Mr. Whitfield, 

our ranking member, for 5 minutes to make an opening statement. 

OPENING STATEMENT OF HON. ED WHITFIELD, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF KENTUCKY 

Mr. WHITFIELD. Chairman Schakowsky, thank you very much for 

holding this important hearing. I might note it is the first hearing 

that we have held on this particular subject looking at these two 

ingredients. I also want to extend our best wishes to Chairman 

Rush. As you indicated in your opening statement, we know that 

he has had some significant health problems, but we hear good 

things about his recuperating and wish him a speedy recovery. 

Obviously, all of us are very much concerned, and it is a priority 

for all of us when we talk about the safety of children and the people of this country. And I think it is important, as I said, that we 

have this hearing to look at these particular chemicals: BPA and 

these phthalates. 

4 

I might add that the European Union was the first governmental 

body to restrict or ban phthalate use, and then they concluded a 

study after effectuation of that ban which demonstrated several of 

the banned or restricted phthalates really pose no risk to human 

health at all. And on BPA there has been no scientific evidence 

that I am aware of that has demonstrated that that might be a 

danger to anyone. And I think because we have the Consumer 

Product Safety Commission reform bill that has passed the House 

and Senate and will soon be going to conference, an effort has been 

made to include in that reform bill a ban of some phthalates. And 

so this hearing certainly is timely because it is important. We are 

going to take that bill up, and we are going to have to make some 

decision about it. 

But I think it is important. I am delighted we have our scientists 

here today, our witnesses here today, who certainly have much 

more knowledge about this than any of us do and will provide us 

information that will help us make hopefully the right decision. I 

would say that one of the companies that will benefit with the ban 

of BPA, for example, actually went around and was making statements and comments and speeches with groups like the People for 

Children’s Health and Environmental Justice, saying that this 

product has arsenic in it, and our product does not have arsenic in 

it, and he was referring to BPA, and it is my understanding that 

BPA does not have arsenic in it. But when we try to make decisions like this certainly the priority is the health and safety of everyone, but we also have to look at what is going to be additional 

cost involved. 

We also have to look at does the substitute product work as well 

as the old product, so I don’t think any of this is just totally cleancut, and it is important that we have this hearing, so I want to 

thank the chairman for having the hearing. We look forward to the 

testimony today because as I said we are going into the conference 

on the Consumer Product Safety Commission reform bill, and this 

is one of the issues that is going to be considered there. So with 

that, I will yield back the balance of my time. 

Ms. SCHAKOWSKY. Thank you, Mr. Whitfield. I recognize the congresswoman who has probably the most expertise with this in 

terms of introducing legislation, and that is Congresswoman Darlene Hooley. 

OPENING STATEMENT OF HON. DARLENE HOOLEY, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OREGON 

Ms. HOOLEY. Thank you, Madam Chair. I first of all would like 

to thank Chairman Rush for keeping his promise to hold this important hearing and thank Congresswoman Schakowsky for 

chairing the hearing today, and of course I thank all of you for 

being here and testifying. Phthalates are chemicals found everywhere in modern life and are the most commonly used plasticizers 

to make plastics flexible. Phthalates are used in all sorts of products but most importantly for today’s hearing, children’s products. 

When children chew on these products, phthalates leach out of 

them. Phthalates are one of the most heavily studied plasticizers, 

and some of the most recent and published studies point to what 

5 

has been called phthalate syndrome, which causes adverse reproductive effects seen in male offspring. 

Although I agree with some testifying today that we are not yet 

at a place where we can say definitively what the direct result of 

phthalates exposure are, there are certainly a growing body of evidence pointing to a causal link between phthalate exposure and serious harm to pregnant women and children. The question this 

committee needs to ask itself is this: at what point does a body of 

evidence, albeit inconclusive, pointing to serious harm to our most 

vulnerable and precious citizens outweigh the possible minor inconvenience to the toy manufacturers that have decided not to use a 

safe alternative? Should we wait for irrefutable proof before we act? 

I believe the answer is no. Although I do not believe that the existing evidence supports a universal ban on phthalates in all products, I do believe it supports banning them from children’s products. 

That is why earlier this year I introduced the Children’s Chemical Risk Reduction Act in cooperation with Senator Feinstein. H.R. 

4030 is similar to the actions taken by California and the UE that 

have already banned the six most commonly used phthalates. I 

urge the conferees of the H.R. 4040 to join the EU, 14 countries, 

California, Washington, and include conference language that 

would ban phthalates for children’s products. Although I have been 

involved in consumer issues my entire life joining this subcommittee has given me the opportunity to look at issues like this. 

The issue of phthalates highlights a striking contrast between European and U.S. regulatory approaches when it comes to actions on 

potentially toxic chemicals. I think Robert Donkers, the EU’s environmental counselor, said it well. Unlike the United States, we 

don’t wait until we have 100 percent proof. If there is fear, scientific suspicions that a chemical could cause irreversible damage 

in the future, we don’t wait. By the time it is definitively proven, 

it could be much too late to do anything about it. 

Ironically, the EU’s decision to ban phthalates in children’s toys 

was based to a large degree on evidence generated by American scientists, much of the funding by the U.S. government, including Dr. 

Earl Gray and Dr. Shanna Swann. I hope we address the following 

issues today. What does the science say regarding phthalates? How 

are other countries dealing with this issue? Are there safe alternatives to phthalates available? Will a phthalate ban cause U.S. 

market disruption? I would also like to enter into the record several letters in support of my legislation. I look forward to hearing 

from both panels today and working with my colleagues on addressing this very serious problem. Thank you. 

Ms. SCHAKOWSKY. Now, Mr. Stearns, for your 5-minute opening 

statement. 

OPENING STATEMENT OF HON. CLIFF STEARNS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF FLORIDA 

Mr. STEARNS. Good morning, and thank you, Madam Chairwoman. I also want to reiterate Mr. Whitfield’s and your comments 

for our concerns and prayers for the chairman, Bobby Rush, and 

hope that he will be back with us soon. We miss him and appreVerDate Nov 24 2008 11:20 Oct 08, 2010 Jkt 037690 PO 00000 Frm 00011 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-125 SCOM1 PsN: JIMC
6 

ciate the opportunity to have this hearing, and at his urging we are 

doing it. 

When you look at this issue, you realize that for almost 50 years 

phthalates have been used in almost every different type of product, whether it is toys or furnishings or medical tubing, pacifiers 

and rattles. It was actually voluntarily stopped in the 1980s by the 

U.S. industry itself. Then when you look at BPA, it is present in 

food containers, plastics, also in liners, can liners, bike helmets, adhesive to baby diapers. So, you have this present sense of these two 

chemicals, and without bringing alarm to the public, we need to 

understand from our experts what is the danger and be sure we 

have good science behind our recommendations as well as good regulations so we don’t have 50 states that have 50 different regulations to make it almost impossible for manufacturers to supply 

these important products. 

I think we are having this hearing, and perhaps it is timely in 

the sense that as others have pointed out that the Consumer Product Safety Commission bill, which will be on the floor shortly, is 

now in conference between the Senate and the House. I am one of 

the ones that serve as a conferee, and I look forward to making 

sure that phthalates and the BPA conditions that are brought out 

perhaps by our witnesses today will be part of this bill. So the witnesses that we have today have a timely opportunity to recommend 

things that we could perhaps put in legislation. This bill will pass 

overwhelmingly under suspension so your time is going to be very 

well spent in proposing what solutions we should provide. 

So, Madam Chairman, we need certainly to perhaps even have 

a second hearing on this. Actually, as we move into regulation and 

examine the science of what the implementation would mean. So 

I look forward to this hearing, and I again commend Mr. Rush for 

pushing forward with this important subject. I yield back. 

Ms. SCHAKOWSKY. And now the gentleman from Georgia, Mr. 

Barrow. 

Mr. BARROW. I thank the chair. I cannot improve upon the opening statement of either the chair or Ms. Hooley, so I will yield the 

opportunity to make an opening. I will waive and reserve my time 

for questions. 

Ms. SCHAKOWSKY. Thank you. The gentleman from Texas, Dr. 

Burgess. Then we will have the gentlewoman from Tennessee, Ms. 

Blackburn. 

OPENING STATEMENT OF HON. MARSHA BLACKBURN, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF TENNESSEE 

Ms. BLACKBURN. Thank you, Madam Chairman, and I do want 

to welcome all of our witnesses today. I appreciate your willingness 

to take up the technical debate regarding the health and safety 

value of phthalates and BPA. These are, as you have heard, two 

common chemicals in consumer products, and the courage wading 

into this issue is not in question nor is the intrinsic value of the 

subject matter itself given the health and safety concerns raised by 

numerous products that the chemicals contribute to. What is in 

question on my part is the timing of the hearing. Given a lack of 

scientific consensus regarding the research prompting criticism reVerDate Nov 24 2008 11:20 Oct 08, 2010 Jkt 037690 PO 00000 Frm 00012 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-125 SCOM1 PsN: JIMC
7 

sponsible for the hearing, it appears more appropriate to address 

what every member on this dais already knows, that the No. 1 consumer issue today in this country is the price of gasoline at the 

pump. 

And, Madam Chairman, I think there is no debate that consumers in my Tennessee district are paying a lot more to fill up 

their tanks than at any other time in American history. On January 7, 2007, in Shelby County, Tennessee we were at $1.96, today 

that is $3.86 a gallon, so it has gone from $1.96 a gallon to $3.86 

a gallon. That is nearly a $2.00 difference since the majority took 

control of Congress of the gavels, and what we are seeing is this 

record increase. And this is something that many people are calling 

a crisis, and that we agree is a crisis and needs to be addressed 

today. So the No. 1 consumer issue in my district is the price at 

the pump. 

I am disappointed that this committee is not taking time to look 

at that issue and to take some action on that issue. Now, Madam 

Chairman, I also am looking forward to a discussion about this 

issue at the appropriate time and to the merits of research prompting the criticism of phthalates and BPA in consumer products. I 

have a grandchild who was just born. My very first grandchild is 

now 1-month old, and I am looking more closely than ever at all 

of these products. And I am also looking at the price of fuel as we 

come and go with that grandchild. So I will have to say that I have 

had no constituents ask me what are we doing on the presence of 

BPA and phthalates and the chemicals in plastics, but what I have 

every single day over and over is a question from consumers when 

in the world is Congress going to take some action on the price of 

gas at the pump. I yield back the balance of my time. 

Ms. SCHAKOWSKY. And now the gentleman from Louisiana, Mr. 

Melancon. OK. Let us try and keep track of everyone here. And 

now the gentleman from Texas, yes, he is here, Dr. Burgess. 

OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A 

REPRESENTATIVE IN CONGRESS FROM THE STATE OF TEXAS 

Mr. BURGESS. Thank you, Madam Chair. It is an interesting 

hearing we have before us today, and I am looking forward to 

learning a good deal more about a subject of which I probably don’t 

know enough, but I am concerned about what the science has to 

say. I think that has got to be first and foremost in our minds. It 

seems as if perhaps industry and the public has gotten ahead, certainly ahead of this committee, which is no surprise, with the head 

of the science and the restructuring of the consumer products that 

are out there. And the other question is, is drastic action needed, 

and the answer right now from what I can tell is the science is inconclusive and drastic action, well, perhaps not yet, but as has already been pointed out some action is being taken. 

I do share some concerns that have previously been voiced by our 

chairman, Mr. Rush, who is not with us today, that if we do not 

complete the scientific information and in fact there is a problem 

and it is unknown whether one of the unintended consequences 

will be that perhaps the products that we would like to see removed will only end up in the discount houses and the resale shops 

in some of the poorer neighborhoods represented by Mr. Rush and 

8 

indeed the poorer neighborhoods represented by myself. So I do 

want us to do a thorough and careful job on this. I don’t think we 

can abrogate that responsibility. It is my understanding that some 

of the testing done in regards to these chemicals involves using a 

syringe to inject the chemicals into the brain of laboratory rats. I 

will submit that people do things in unusual ways. I never cease 

to be amazed at the inventiveness of people, but I don’t recall hearing about anyone injecting themselves with phthalates or BPA into 

their brain. 

So some of the studies perhaps seem to be situations that you 

would never find in common clinical practice. I do want to say one 

thing about the timing of this hearing. It has already been mentioned that H.R. 4040, Consumer Product Safety Commission reauthorization is in conference right now. It is my understanding that 

the principals have yet to meet in conference. The legislation surrounding these products was introduced on the Senate side and 

never on the House side, and I hope we are not using this hearing 

today as an excuse to put something hastily into that conference 

report and then have that come to the floor without the House having done its due diligence and its work on understanding the 

science of these compounds, so we have got a lot to get through 

today. Madam Chairwoman, I yield back the balance of my time. 

Ms. SCHAKOWSKY. Seeing no other members, I want to at this 

time welcome our witnesses and introduce the first panel. We have 

Dr. Michael A. Babich, a chemist at the Directorate for Health 

Sciences of the Consumer Product Safety Commission. Dr. Babich 

focuses on risk assessments of chemicals found in consumer products. We have Dr. John Bucher, Associate Director of the National 

Toxicology Program at the National Institute of Environmental 

Health Sciences, part of the National Institutes of Health. Dr. 

Bucher is a pharmacologist and is responsible for oversight of the 

National Toxicology Program’s review of BPA. Dr. Bucher is also 

responsible for toxicology and carcinogenesis studies, the NTP report on carcinogens, and the NTP center for the evaluation of risks 

to human reproduction. Dr. Norris Alderson is Associate Commissioner for Science at the Food and Drug Administration. Dr. 

Alderson is responsible for coordination of science issues across the 

agency, the Office of Women’s Health, Office of Orphan Product Development, the Good Clinical Practices Staff, oversight of FDA 

sponsored clinical studies, research integrity, standards coordination, and scientists peer review. Dr. L. Earl Gray, Jr. is a research 

biologist with the Environmental Protection Agency. Dr. Gray’s 

work on phthalates has focused on effects of phthalate mixtures. 

He serves on the editorial board of the Journal of Toxicology and 

Environmental Health. 

I will ask the witnesses if they have opening statements to 

please take up to but no more than 5 minutes for your opening 

statement. We will begin from my left, your right, with our first 

witness, Dr. Babich. 

9 

STATEMENT OF MICHAEL A. BABICH, PH.D., CHEMIST, CONSUMER PRODUCT SAFETY COMMISSION, BETHESDA, MARYLAND 

Dr. BABICH. Good morning, Madam Chair and committee members. I am Dr. Michael Babich, a chemist in the Directorate for 

Health Sciences at the U.S. Consumer Product Safety Commission. 

It is my pleasure to come before you today to offer testimony on 

phthalates and bisphenol-A. CPSC’s regulatory authority over 

chemical substances stems from the Federal Hazardous Substances 

Act or FHSA. Under the FHSA, CPSC must consider both toxicity 

and exposure to determine whether a product may be considered 

a hazardous substance. Children’s products containing a hazardous 

substance are automatically banned. 

Phthalates are chemicals that are added to the plastic polyvinyl 

chloride or PVC to make it flexible. There are several types of 

phthalates present in a variety of consumer products. In the early 

1980s the primary phthalate used in children’s products was di-2- 

ethylhexyl phthalate, DEHP. When a National Toxicology Program 

study showed that DEHP caused cancer in animals, CPSC initiated 

a regulatory proceeding. The regulatory proceeding was withdrawn, 

however, when manufacturers voluntarily removed DEHP from 

teethers, rattles, and pacifiers. A voluntary ban was later incorporated into the ASTM toy standard, and DEHP was replaced with 

another phthalate, diisononyl phthalate or DINP. 

In November, 1998, the Commission received a petition requesting a ban of PVC in children’s products due in part to concern 

about phthalates. In December of 1998, manufacturers voluntarily 

agreed to stop using DINP in teethers, rattles, and pacifiers. When 

manufacturers voluntarily removed DINP from these products they 

had two options: replace PVC with another plastic that does not require a plasticizer or substitute another type of plasticizer for 

DINP. None of the substitutes is as well studied as DINP and for 

some substitutes little or no toxicity data are available. To assess 

the potential health risks from DINP, CPSC staff collaborated with 

scientists in Europe and Canada to develop a laboratory method to 

measure the migration of DINP from products. 

The staff conducted an observational study of children’s mouthing behavior, and the Commission convened a Chronic Hazard Advisory Panel or CHAP to review the potential health risks associated with DINP. The CHAP concluded that for DINP to pose a risk 

of injury to young children, they must routinely mouth DINP containing toys for at least 75 minutes per day. For the majority of 

children, the CHAP concluded that exposure to DINP would pose 

a minimal to non-existent risk of injury. The staff’s observational 

study, completed after the CHAP’s report, showed that mouthing 

times for these products were much lower than the 75 minutes per 

day that the CHAP identified as a minimum level of concern. 

The staff estimated that the upper-bound DINP exposures from 

mouthing these products were 100 times below the acceptable daily 

intake. Therefore, CPSC staff concluded that exposure to DINP in 

these products did not present a health risk to children. In February of 2003, the Commission voted unanimously to deny the petition requesting a ban of PVC in children’s products. 

10 

Bisphenol-A or BPA is a chemical used to make polycarbonate 

plastics and epoxy resins. Most human exposure to BPA comes 

from food. According to the recent report from the National Toxicology Program, Center for the Evaluation of Risk to Human Reproduction, as much as 99 percent of BPA exposure to children is 

from food. The products that have the greatest potential for BPA 

exposure are under the jurisdiction of the U.S. Food and Drug Administration. 

Polycarbonate is also used in some products that fall under 

CPSC’s jurisdiction, including compact disks, protective eyewear, 

shatter resistant windows, helmets, and other protective equipment. It is used in these products because of its strength, and the 

BPA exposure from these products is likely to be negligible. In considering proposals to ban phthalates and BPA in children’s products, it is important to consider that there is little information 

about the toxicity of some DINP substitutes. Additionally, the important role of polycarbonate in protective equipment and safety 

glass should be considered. A ban of BPA in children’s products 

could result in less effective protection from head, eye, and other 

injuries. 

Thank you for the opportunity to speak to you today. I will be 

happy to answer your questions. 

[The prepared statement of Dr. Babich follows:] 

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Ms. SCHAKOWSKY. Thank you. Dr. Bucher. 

STATEMENT OF JOHN R. BUCHER, PH.D., ASSOCIATE DIRECTOR, NATIONAL TOXICOLOGY PROGRAM, NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES, NATIONAL 

INSTITUTES OF HEALTH 

Dr. BUCHER. Thank you, Madam Chairman, and good morning. 

I am John Bucher, Associate Director of the National Toxicology 

Program. The NTP is an interagency program, funded and managed by the National Institute of Environmental Health Sciences. 

NIEHS and NTP are part of the National Institutes of Health. The 

NTP carries out toxicology research and testing on substances of 

concern to the Federal Government and the public. We also perform literature review and analysis activities and since 1980 have 

produced the Report on Carcinogens. In 1998, we established the 

Center for the Evaluation of Risks to Human Reproduction, 

CERHR, which carries out literature evaluations on substances 

that may affect human reproduction and development. 

The NTP has extensively researched phthalates for cancer and 

reproductive effects in animals, and through the CERHR, has reviewed the world’s literature on seven phthalates for potential effects on human reproductive health. We have studied bisphenol-A, 

BPA, less extensively in animals, although recently we conducted 

a lengthy evaluation of the very large literature on the potential 

for BPA to affect reproduction and development. This evaluation 

culminates tomorrow with a public peer review of the Draft NTP 

Brief on Bisphenol-A before our NTP Board of Scientific Counselors. This draft brief represents our opinion of the science on BPA 

and is based on our evaluation to date of the literature, informed 

by the findings of an expert panel and with consideration of public 

comments solicited on five separate occasions. 

BPA is a high-production industrial chemical used to manufacture polycarbonate plastics and epoxy linings of tin cans. It has 

been known since 1938 to mimic estrogen when given in large 

amounts to experimental animals. More recently, it has also been 

studied for its ability at very much lower doses to affect hormonal 

processes involved in development, when an animal is exposed as 

a fetus or during infancy. BPA leaches in small amounts from plastic items such as polycarbonate baby bottles and can be measured 

in infant formula coming from epoxy-lined cans. The 2003 

NHANES survey conducted by the CDC found detectable levels of 

bisphenol-A in 93 percent of over 2,500 hundred urine samples 

from people 6 years of age and older. These data are considered 

representative of exposures in the United States. 

The best estimates that we have suggest that the doses of BPA 

causing subtle effects on the development of animals are close to 

estimates of current exposures to the general U.S. population. Taking this information into account, the NTP reached several preliminary conclusions in our draft brief. We expressed some concern 

that current estimated exposures of BPA to fetuses, infants, and 

children could cause neural and behavioral effects, effects on the 

prostate and mammary gland, and an earlier age at which females 

attain puberty. We express negligible concern or minimal concern 

that current exposures to BPA could cause adverse health effects 

25 

in other segments of the population. Some concern is the midpoint 

of a 5-level scale. The levels are negligible concern, minimal concern, some concern, concern, and serious concern. 

Although we agreed with our expert panel in expressing some 

concern for current exposures to BPA concerning neural and behavioral effects, we expressed an elevated level of concern, some concern, over the conclusions reached by our expert panel for changes 

to the prostate as well as earlier puberty in females. The expert 

panel did not specify a level of concern for the mammary gland. 

These elevated concerns were based on new literature, on clarifications provided in public comments to studies that were considered 

of low utility by our expert panel, and scientific justification for 

using data from studies utilizing non-oral routes of exposure to 

neonatal animals. 

There are a number of uncertainties in the scientific information 

on BPA. The literature from experimental animal studies is large, 

but with many conflicting findings. There are insufficient data from 

studies in humans to determine directly whether BPA is affecting 

human reproductive health. The studies we base some concern on 

are not the traditional safety assessment studies done according to 

regulatory guidelines. Rather, they are smaller studies carried out 

in academic laboratories. These have often examined subtle developmental endpoints in experimental animals that are more difficult 

to interpret with regard to how they contribute to the weight of evidence for human health effects. 

Despite the limitations of these studies, the NTP determined 

that because the effects in animals occur at BPA exposure levels 

similar to those experienced by humans, the possibility that BPA 

may alter human development could not be dismissed. As I mentioned earlier, the NTP Board of Scientific Counselors will review 

this draft brief at its meeting tomorrow, and we will take their recommendations under consideration, and the final brief will be published later this year. 

Turning to phthalates, the NTP has conducted 13 cancer bioassays and 45 studies on reproductive or developmental toxicity 

with various phthalate esters. It has been known for more than 25 

years that phthalates can affect reproduction. Fetal animals are 

more sensitive than newborns, which are in turn more sensitive 

than older animals. Not all phthalates produce adverse reproductive effects in animals, but those that do cause similar toxicity to 

the developing rat fetus when exposures occur during a critical 

window of sexual differentiation during pregnancy. 

These agents induce malformations in the male reproductive 

tract by affecting development that is mediated through androgens, 

for example, testosterone, and the most severe manifestations occur 

with higher doses. In addition, some phthalates when administered 

to the developing fetus can also induce subsequent testicular tumors in the adult animal after being exposed only during the short 

window of pregnancy. A few small studies in humans have linked 

maternal exposure to specific phthalates with adverse outcomes in 

their children, including decreased testosterone levels in boys, but 

additional research is needed to confirm these findings. Failure of 

normal development of the testes has been proposed to explain increases in certain male reproductive problems. However, thus, far, 

26 

no cause and effect relationship has been established between any 

environmental agent and these specific human outcomes. 

As I mentioned earlier, the CERHR has reviewed the literature 

on phthalates, and we expressed serious concern for male infants 

for whom exposure to DEHP during certain medical treatments 

could adversely affect development of the reproductive tract. We expressed concern for male offspring of women undergoing certain 

medical treatments during pregnancy or breastfeeding, and for infants less than 1 year old exposed to DEHP by diet or mouthing 

DEHP-containing objects. We expressed some concern for male children who may be exposed to levels of DEHP higher than those to 

the general population. 

In summary, we have conducted extensive experimental studies 

on phthalates and through the CERHR have evaluated phthalates 

and BPA. We maintain an objective, science-based approach in 

dealing with critical issues in toxicology, and we provide sound scientific information on substances of concern to regulatory agencies 

and the public, contributing to the public health discussions surrounding these important chemicals. Thank you very much for this 

opportunity to appear today before you. I would be happy to answer your questions. 

[The prepared statement of Dr. Bucher follows:] 

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Ms. SCHAKOWSKY. Dr. Alderson. 

STATEMENT OF NORRIS ALDERSON, PH.D., ASSOCIATE COMMISSIONER FOR SCIENCE, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES, 

ROCKVILLE, MARYLAND 

Dr. ALDERSON. Good morning, Madam Chair, and members of 

the subcommittee. I am Norris Alderson, Associate Commissioner 

for Science at the FDA. Thank you for providing an opportunity to 

discuss FDA’s ongoing work regarding the safety of bisphenol-A. 

This past April, FDA Commissioner Dr. von Eschenbach, formed an 

agency-wide BPA task force, which I chair, to conduct a review of 

the concerns raised in a recent review of the literature on the safety of BPA. The task force is undertaking a cross agency look at the 

current research and information on the safety of BPA. Although 

our review is ongoing, at this time we have no reason to recommend that consumers stop using products containing BPA. 

A large body of evidence indicates that currently marketed products containing BPA such as baby bottles and food containers are 

safe, and that exposure levels to BPA from these products are well 

below those that may cause health effects. I also want to emphasize that research on the safety of BPA is a very active area. If 

FDA’s review leads us to a determination that the use of BPA is 

not safe, we will not hesitate to take action to protect the public 

health. I also want to note that at FDA’s request a subcommittee 

of the FDA science board will review our task force report on the 

safety of BPA and will hold a public meeting on the topic later this 

year. The science board, which is an independent advisory body to 

FDA, will receive the findings of the subcommittee during its fall 

meeting. 

Bisphenol-A is used in the manufacture of two types of polymers 

used in food contact articles. Polycarbonate plastics are used in 

products such as water and infant bottles, while epoxy-based enamels and coatings are widely used as inner linings for food and beverage cans. These food contact substances have been regulated by 

FDA for many years. Small residual amounts of trace BPA can remain in polymers and may migrate to food during the use of the 

product. For this reason, FDA’s safety assessments include a consideration of likely consumer exposure. We have determined that 

dietary exposure to BPA from these uses is in the very low parts 

per billion range. The task force is looking at all products we regulate to get a better understanding of the total exposure. 

We are already focusing on the specific concerns raised by the reports that Dr. Bucher just talked about. In November of 2007, the 

NTP Center for Evaluation of Risks to Human Reproduction released its expert panel report which stated that there are minimal 

concerns for BPA exposure to pregnant women, fetuses, infants, 

and children. The NTP draft report later in April of this year reiterated that panel’s conclusions but upgraded some of those concerns. These analyses included relatively new data and emerging 

or difficult to interpret endpoints in toxicology, and considered the 

fact that the studies currently available provide limited evidence 

and contain numerous uncertainties. 

35 

FDA has carefully studied the report and conclusions of the 

NTP’s expert panel, and we are actively reviewing the NTP task 

force report. Also, FDA’s National Center for Toxicological Research 

in Jefferson, Arkansas is discussing with the NTP additional research needs relating to BPA. Neural and behavior development effects were also the focus of a recent draft risk assessment released 

by Health Canada and Environment Canada in April. FDA has 

been discussing this report with our Canadian counterparts. The 

NTP draft brief and the Canadian draft risk assessment both suggest that more research is needed. FDA itself began a formal risk 

reassessment of BPA in early 2007. FDA’s initial reevaluation of 

BPA safety focused on possible low dose effects, and we concluded 

that the current level of exposure to adults and infants is safe. 

This conclusion was based on a review of the most relevant data, 

including our reviews completed in July, 2007, on two pivotal 

multi-generational studies. FDA’s findings thus far are supported 

by the conclusions of two risk assessments conducted by the European Food Safety Authority and the Japanese National Institute of 

Advanced Industrial Science and Technology. Let me briefly mention phthalates, which are also a concern to this subcommittee. The 

BPA task force is also compiling a comprehensive inventory of FDA 

products that contain phthalates. FDA, primarily through NCTR, 

is conducting research to broaden our understanding of potential 

health risks posed by exposure to phthalates. 

In conclusion, let me emphasize that current evidence indicates 

that BPA exposure from food contact materials is well below the 

levels that may cause health effects, but FDA’s conclusions on the 

safety of the products it regulates are never set in stone. They are 

always subject to review or revision when new data or better analyses become available. At the end of the day, FDA’s goal is always 

to act within our authority to protect the public health. Thank you 

for the opportunity to testify today. I will be happy to answer any 

of your questions. 

[The prepared statement of Dr. Alderson follows:] 

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Ms. SCHAKOWSKY. Dr. Gray. 

STATEMENT OF L. EARL GRAY, JR., SENIOR REPRODUCTIVE 

BIOLOGIST AND TOXICOLOGIST, REPRODUCTIVE TOXICOLOGY DIVISION, OFFICE OF RESEARCH AND DEVELOPMENT, ENVIRONMENTAL PROTECTION AGENCY 

Dr. GRAY. Good morning, Ms. Chairman, and members of the 

committee. My name is Earl Gray, and I am a senior reproductive 

biologist and toxicologist in the Reproductive Toxicology Division in 

the Office of Research and Development of EPA. The views expressed here in my testimony today represent my personal views 

as a scientist and do not necessarily reflect the position of the EPA 

or the Administration. My research at EPA has focused on the effects of chemicals including endocrine disrupters on the cellular 

and molecular modes of toxicity leading to abnormal reproductive 

development in rodents, and we have studied a variety of chemicals 

including phthalates and bisphenol-A. 

In these studies, rat mothers are exposed to an individual chemical or a mixture of chemicals during pregnancy, and the offspring 

are examined after birth to determine if the chemical induced adverse effects. Phthalates are a high production volume chemical 

used in many consumer products including toys, baby products, 

pharmaceuticals, cosmetics, personal care products, and medical 

devices. The phthalates are ubiquitous in our daily environment 

and most people, including pregnant women and their fetuses, are 

exposed to multiple phthalates. In rats, some phthalates cause 

liver cancer, spontaneous abortions, and reproductive tract malformations in male and female rat offspring. The abnormalities 

seen in the male rat offspring are described as phthalate syndrome. 

This syndrome is the focus of many regulatory agencies since it occurs at lower dosage levels than other adverse effects. 

The phthalate syndrome is manifested by undescended testes, 

malformations of the penis and internal reproductive tract and 

shortened ano-genital distance in males. The process that is disrupted is known as sexual differentiation. It is a process common 

to all mammals including humans. During sexual differentiation, 

phthalates disrupt testis function reducing fetal androgen levels 

which in turn causes abnormal male reproductive tract development, and in fact there are a variety of human syndromes associated with disruption of this pathway. Recently concerns have been 

expressed about the effects of mixtures of phthalates since humans 

are exposed to multiple phthalates at one time. Studies with rats 

show that combining phthalates with other phthalates or with pesticides cause cumulative adverse effects. They do not act independently. 

A key question is how do the levels of phthalates that affect rats 

compare with human exposures? In the last few years several studies have shown that although phthalate levels in most humans are 

low, a small percentage of people are exposed to much higher levels 

of phthalates, and when one compares the level of phthalate metabolites in human versus rat amniotic fluid, the environment that 

the fetus develops in, the levels in humans aren’t always that different from those in affected rats, thus the margin of exposure is 

not always as large as one would like. Using the National ToxiVerDate Nov 24 2008 11:20 Oct 08, 2010 Jkt 037690 PO 00000 Frm 00054 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-125 SCOM1 PsN: JIMC
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cology Program scale, my concern about phthalates are that I have 

serious concern about the potential effect of phthalates in children 

and women of child-bearing age exposed during medical interventions and concern for exposure to phthalates in all other women 

and children, women of child-bearing age and children. 

Bisphenol-A is a high production volume chemical used in the 

synthesis of polycarbonate plastics and found in many consumer 

products, including baby bottles and can liners. The most recent 

study show that people are exposed to low levels of BPA. The concerns about BPA expressed here are from the National Toxicology 

Program expert panel final report of 2007, of which I was a member. This report included our independent evaluation of several 

hundred papers on the reproductive and developmental toxicity of 

BPA. The NTP BPA expert panel expressed some concern for neural behavior effects of BPA in humans, whereas all other effects 

were either negligible or minimal concern. 

In summary, I have a higher level of concern for some phthalates 

than for bisphenol-A based upon the consistency of the adverse effects of some phthalates among many laboratories, the relevance of 

the effects to humans, and the high dose exposures to some people. 

Thank you, Chairman and members of the subcommittee for the 

opportunity to discuss EPA’s work on phthalates and BPA, and I 

look forward to answering any questions that you have. 

[The prepared statement of Dr. Gray follows:] 

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Ms. SCHAKOWSKY. I want to thank the witnesses for their testimony, and we will begin the questioning now. I will begin with that 

questioning for 5 minutes. I wanted to ask Dr. Babich, there seems 

at least to me to be some confusion in the media and even in some 

testimony, are there phthalates in teethers, rattles, and pacifiers, 

and, if so, which phthalate? 

Dr. BABICH. In 2002 there were no phthalates in teethers, rattles, or pacifiers. 

Ms. SCHAKOWSKY. Do you know that because CPSC actually tested it? 

Dr. BABICH. In 2002, we tested teethers, rattles, soft plastic toys, 

the kinds of products that children mouth, and there were no 

phthalates in teethers, rattles, and of course pacifiers, and about 

40 percent of the soft plastic toys contained DINP. There were for 

the most part very few that had phthalates. Some had phthalate 

substitutes. 

Ms. SCHAKOWSKY. So there was a voluntary agreement in which 

the industry agreed to exclude DEHP and DINP from toys also. 

What percentage did you say was still present in toys? 

Dr. BABICH. Well, in 2002 the soft plastic toys, which were not 

part of the agreement, 40 percent of them had DINP. 

Ms. SCHAKOWSKY. They were not part of the—— 

Dr. BABICH. Not part of the agreement applied to teethers, rattles, and pacifiers. 

Ms. SCHAKOWSKY. Do foreign manufacturers comply with these 

voluntary agreements? 

Dr. BABICH. In 2002, we surveyed pretty much everything we 

could get our hands on, and that is what we found. 

Ms. SCHAKOWSKY. And so there is no ongoing—— 

Dr. BABICH. So, yes, I would say that as far as we know they do 

comply. 

Ms. SCHAKOWSKY. OK. And there is no ongoing testing or—— 

Dr. BABICH. Not at the moment, no. 

Ms. SCHAKOWSKY. But unlike the FDA, the CPSC doesn’t have 

pre-market approval of chemicals, is that correct? 

Dr. BABICH. True. 

Ms. SCHAKOWSKY. That is true. Dr. Bucher, in your testimony 

you referred to active phthalates. I wondered if you could expand 

on that, which phthalates are considered active and why, what 

makes them active? 

Dr. BUCHER. Well, there are certain phthalates based on their 

structure that when metabolized break down to common toxic 

intermediates, and both Dr. Gray and Dr. Foster, who is accompanying me, are world experts on phthalates and probably would 

be better to address this issue, but when I mentioned active 

phthalates it is those that are toxic as opposed to those classes of 

phthalates that are in fact not toxic. 

Ms. SCHAKOWSKY. Did you want to comment on that then, Dr. 

Gray? 

Dr. GRAY. Yes. I agree with Dr. Bucher’s comments. Some 

phthalates have no activity in inhibiting fetal rat testosterone synthesis and others are active in this assay. It is determined by the 

structure activity, and the interesting structure activity for the 

fetal effects is similar to that seen for the testicular effects in the 

68 

pubertal male rats. In the written testimony we provided, we tried 

to include a table of a few of the phthalates that we have examined 

and the relative potencies for their ability to either inhibit fetal testosterone or cause reproductive tract malformations in the male. 

Ms. SCHAKOWSKY. So the active ones that were banned by the 

EU? 

Dr. GRAY. Not entirely, no. There were three phthalates in one 

category that included DEHP, DBP, and BBP, and those are active. 

There are several other phthalates that have this reproductive toxicity that are not included in the EU list. Some of them we have 

found to be more potent than those 3. 

Ms. SCHAKOWSKY. I wanted to understand why you selected the 

particular nine phthalates that you did for conducting your research. You did not include—did you include DIDP or DNOP? 

Dr. GRAY. We have not done more phthalates. We would like to 

look at more phthalates though. It is just a question of time and 

resources. We have just started doing these structure activity correlations on fetal androgen levels in the last couple of years so 

there are several more we would like to look at. The DNOP, you 

could be referring to a different structural formulation, so we have 

looked at the di-ethylhexyl terth ally, which has a structure similar 

to DEHP and it is inactive because the chains are in a different 

position on the ring, so there are a large number of phthalates that 

we have not looked at. 

Ms. SCHAKOWSKY. The point is that they are still on your agenda 

to look at? 

Dr. GRAY. Yes, until I retire. 

Ms. SCHAKOWSKY. OK. After 30 years already, right? 

Dr. GRAY. Oh, but it is fun. 

Ms. SCHAKOWSKY. OK. Mr. Whitfield. 

Mr. WHITFIELD. Thank you, Madam Chairman, and thank you 

all for taking time to be with us today, and we appreciate your testimony very much. Just to make sure I understand all this. Right 

now there are no phthalates in any teething or rattles that children 

might put in their mouth, is that correct? 

Dr. BABICH. Right now there are no phthalates in teethers, rattles, or pacifiers but they can be in other kinds of children’s products. 

Mr. WHITFIELD. But in that category the manufacturers voluntarily removed it, is that correct? 

Dr. BABICH. Voluntarily removed it. 

Mr. WHITFIELD. And then if we look at all other toys with 

phthalates 40 percent of all other toys would have phthalates in 

them. 

Dr. BABICH. Right. That is based on our 2002 data, yes. 

Mr. WHITFIELD. OK. Now, Dr. Gray, I noticed when you testified 

you said that you were not testifying on behalf of EPA but you 

were testifying personally today, is that correct? 

Dr. GRAY. That is correct, as a scientist. 

Mr. WHITFIELD. Now what about the other 3, are you all testifying for your agencies or are you testifying personally? You are 

testifying for your agencies? Now why did EPA not want to testify 

as an agency today? 

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Dr. GRAY. Well, my understanding was that there was a request 

for me to come to present the scientific issues on the phthalates 

and bisphenol-A and not on the policy, so I can’t handle policy 

questions but I can answer scientific questions in more detail 

than—— 

Mr. WHITFIELD. Does the EPA have a policy on these two chemicals? 

Dr. GRAY. They have regulatory action ongoing. They have begun 

risk assessments on some of the phthalates in ORD, and those are 

planned in OPTS on completion of the National Academy of 

Sciences Committee review on the cumulative effects of phthalates. 

Mr. WHITFIELD. OK. 

Dr. GRAY. And I know that they plan to look into a risk assessment on bisphenol-A, I think when the NTP has released its final 

report on bisphenol-A. 

Mr. WHITFIELD. Now the European Union was the first governmental entity that banned any phthalates, is that correct? 

Dr. GRAY. I believe so. 

Dr. BABICH. I believe so. 

Mr. WHITFIELD. And what year was that? 

Dr. BABICH. I am not certain of the exact year. They had a temporary ban around ’98, ’99, and then a couple of years ago it was 

sort of finalized. 

Mr. WHITFIELD. OK. 

Dr. BABICH. I could check the exact dates. 

Mr. WHITFIELD. Now have you all had an opportunity to review 

the scientific data on which they made their decision? 

Dr. BABICH. Well, in fact, we worked with the various European 

scientists during the entire process because we realized that it is 

an international problem that we all faced. We also after all the 

work was completed, we had a series of teleconferences with the 

European scientists to discuss whatever the differences may be. 

Now we looked at only one phthalate, DINP, because that is all 

that was being used. As far as that one phthalate goes, we decided 

that on a scientific level we were virtually 100 percent in agreement. 

Mr. WHITFIELD. On that one. 

Dr. BABICH. On the scientific issues relating to that one phthalate. 

Mr. WHITFIELD. And what was that conclusion? 

Dr. BABICH. Well, that exposure from these products was too low 

to present a hazard. 

Mr. WHITFIELD. And the Europeans agreed with that as well? 

Dr. BABICH. The European scientists agreed with that as well. 

Mr. WHITFIELD. Then why did they ban all six or seven of these? 

Dr. BABICH. Their regulatory process is very different from ours. 

In the U.S. we have regulatory agencies that issue regulations. In 

the EU, they are not regulations. They have legislation, so it is a 

different process. 

Mr. WHITFIELD. OK. Now you all are regulators, and I know on 

the second panel we are going to have—you are not regulators? The 

agencies are involved in regulation, FDA. 

Dr. BABICH. I am involved in regulation. 

70 

Mr. WHITFIELD. Are you aware of any substitutes that can readily be used for phthalates? I know that there is this—are there 

available substitutes? 

Dr. BABICH. Well, we have been trying to compile a list. There 

are several that were used back in 1999 when they voluntarily took 

out the phthalates from some products, and there is a long list of 

substitutes, but as far as we can tell none of them is as well studied as the phthalates, and for some of them we could find little or 

even no data. 

Mr. WHITFIELD. So that is of concern. 

Dr. BABICH. Well, that is a concern to us, and in fact we are 

starting to look at the toxicity, just beginning to look at the toxicity 

of the phthalate substitutes. 

Mr. WHITFIELD. I see my time has expired, Madam Chair. 

Ms. SCHAKOWSKY. OK. Next, the gentlewoman from Colorado, 

Ms. DeGette. Oh. Thank you. Ms. Hooley from Oregon. 

Ms. HOOLEY. Thank you, Madam Chair. I have a series of questions. Dr. Gray, animals exposed to the phthalates have shown serious health problems such as liver cancer, kidney cancer, male reproductive organ damage, but have any studies shown that 

phthalates cause health problems in humans? We know what happens in animals, but what about humans? 

Dr. GRAY. Well, there are a variety of epidemiological studies 

that have reported associations between health effects in humans 

and phthalate exposures. And I submitted a list of those in the 

briefing package. It is included with the written testimony. They 

show a correlation between levels and effect so they are not causal 

associations. 

Ms. HOOLEY. Are phthalates, this is for Dr. Gray again, aren’t 

the phthalates exposure levels in rodent studies much higher than 

levels found in mothers and infants, and most research indicate 

that humans are less sensitive than rodents to phthalates? 

Dr. GRAY. Well, on the first question I think that the majority 

of the literature which is fairly recent and not that large shows 

that the majority of people and amniotic fluid levels are exposed to 

very low levels that are well below the doses we use in our animal 

studies but the distribution of phthalate exposures is several orders 

of magnitude and there are some very skewed high values resulting from exposure to specific products. We are not always sure 

what they are. So in those cases we have compared the levels in 

rats to the levels in humans. They are not as large as we generally 

would care for, and so when we compare human amniotic fluid levels to rat amniotic fluid levels in affected rats for di-butyl 

phthalates and metabolite the highest level in humans was only 

one-fifth that of a dose that produced an effect in the rat. So that 

is not such a wide margin exposure. 

Ms. HOOLEY. Right. But there was also in the Journal of Human 

Reproduction, one of the things they said is that it was found—humans were found to be 10 times more sensitive than rodents. Do 

you agree with that statement? 

Dr. GRAY. I agree that it must have been published there, but 

I think that is an—that would have to be considered an interesting 

hypothesis, and I don’t know how you would confirm that. 

71 

Ms. HOOLEY. OK. OK. Dr. Bucher, have scientists representing 

the European Union concluded that DINP is safe? 

Dr. BUCHER. I would have to call on Dr. Foster. Do you want to 

answer that? We are not specifically dealing with issues related to 

the regulations in the European Union with regard to phthalates. 

Ms. HOOLEY. But the European Union did ban six phthalates, 

right? 

Dr. BUCHER. Yes, they did. 

Ms. HOOLEY. Pardon? 

Dr. BUCHER. Yes, they did. 

Ms. HOOLEY. Dr. Bucher, if phthalates are banned, won’t the industry be forced to use unsafe alternatives or are there safe alternatives? 

Dr. BUCHER. Well, that is an excellent question that any of the 

panelists might be able to weigh in on. I have no specific information on the substitutes for the phthalates that would be used in 

place of the banned materials. It is conceivable that they are safe. 

It is conceivable that they are not safe. Unless we have information 

on what those are and what kind of testing has been done, it is impossible to tell. 

Ms. HOOLEY. My understanding is that there are several big 

stores like Wal-Mart and Target and Babies-R-Us that said we 

would promise to remove or severely restrict children’s products 

containing phthalates by the end of this year. Why are they doing 

that? 

Dr. BUCHER. I really can’t answer the question. I was under the 

impression that that was referring to the BPA-containing materials, but I may be mistaken. 

Ms. HOOLEY. For any one of you, in 1998 the CPSC released the 

results of a study on DINP saying that few if any children are at 

risk from the chemical because the amount that they would ingest 

does not reach a level that would be harmful. However, the study 

identified several areas of uncertainty where additional scientific 

research is needed and the agency asked industry to voluntarily remove phthalates from teethers and rattles. Unfortunately, not all 

manufacturers have removed phthalates from these products and 

teethers and other children’s products with phthalates have been 

found on store shelves. Also, the CPSC Chronic Hazard Advisory 

Panel found that children up to 18 months old who put PVC plastic 

toys in their mouth may exceed the recommended acceptable intake 

of DINP. This implies that there may be DINP risk for any young 

children who routinely mouth plasticized toys for 75 minutes a day 

or more. Dr. Bucher, shouldn’t the CPSC establish federal regulations for phthalates and shouldn’t these regulations pre-empt state 

law? 

Dr. BABICH. Well, may I try to answer that question? First of all, 

you mentioned the 1998 CPSC report where we identify sources of 

uncertainty, and we recommended three steps to address those 

sources of uncertainty, a better method to measure migration, a 

better observational study, and to convene the CHAP, the Chronic 

Hazard Advisory Panel. We did all of those things. In 2002 we completed our final report which was released towards the end of 2002. 

Because a separate study gathering exposure data was just beginning while the CHAP was holding their meetings and conferring, 

72 

they didn’t have the advantage of these data. They had in fact a 

difficult task trying to estimate what the exposure might be. 

Once we had the data to do that accurately, we found that the 

exposure was extremely low on the order of one microgram per 

kilogram per day, whereas the acceptable daily intake was 120 

micrograms per kilogram per day. And we also found that the 

mouthing times were quite low on the order of 1 or 2 minutes per 

day. Even when you look at the upper bounds, 95th, 99th percentiles, the mouthing times were very low, so as a result the exposures were much lower than the CHAP could have anticipated. 

Ms. HOOLEY. Just one quick question at the end, and I know my 

time is up. Dr. Babich, the study that you did, my question is 

knowing that there are various types of phthalates in toys and 

studies have shown that combining phthalates together with pesticides have a cumulative effect, would you say your study is representative of real world exposure? 

Dr. BABICH. OK. First of all, teethers and rattles have no 

phthalates. 

Ms. HOOLEY. Right. 

Dr. BABICH. Some soft plastic toys have phthalates, but primarily 

DINP. DINP is not like some of the other active phthalates that 

Dr. Gray spoke about. DINP has some of those same effects but it 

is much weaker than the other phthalates. So as a result, those endocrine effects, the reproductive developmental effects become less 

important, and there were other health end points that for DINP 

were more important. So in that regard it is difficult to say, I 

think, in the toys we looked at, it is really only DINP that we were 

concerned about that we looked at. And it is not like some of the 

other phthalates that we have heard about today. 

Ms. HOOLEY. Thank you. Thank you, Madam Chair. 

Ms. SCHAKOWSKY. Mr. Stearns. 

Mr. STEARNS. Thank you, Madam Chair. Dr. Gray, I have a report here that is from June 10, 2008. There was testimony by Dr. 

Norris Alderson, Department of Health and Human Services, and 

in the report he says that the agency, FDA, has been studying BPA 

for many years and did a final assessment of the chemical in early 

2007. And reading from the report, it says FDA’s reassessment of 

possible low dose effects of BPA concluded that the current level of 

exposure to adults and infants is safe as defined in, and then it 

mentions the regulation. Yet at the same time the press is carrying 

reports there are hundreds of studies supporting harm caused by 

BPA. So based upon this and these other reports, which is it? Well, 

OK, I can ask Dr. Alderson. 

Dr. ALDERSON. As a result of the current review that NTP has 

conducted and the process they are going through, FDA has since 

early 2007 been reassessing all available information on BPA. The 

task force is currently looking at the total exposure from all FDA 

products. 

Mr. STEARNS. I understand that but what you say here is that 

the low dose concluded that the current level of exposure to adults 

is safe, so you stand by that, don’t you? 

Dr. ALDERSON. We still stand by that today. 

Mr. STEARNS. Why are there reports, hundreds of studies reporting that there is harm? 

73 

Dr. ALDERSON. Well, in the literature there are a lot of studies 

which Dr. Bucher and his staff have reviewed in their report that 

do not meet what we call a regulatory standard in determining safe 

levels. 

Mr. STEARNS. Would it be safe to say that a lot of these studies 

then do not meet a regulatory standard that you did when you did 

your report? 

Dr. ALDERSON. That is true, but I want to emphasize that when 

we make an assessment we look at all the available data and information regardless of whether it meets the regulatory standard or 

not. That is what our scientists do, and we assess all of the information. 

Mr. STEARNS. Dr. Gray, does the quality of a study matter if it 

is dictated directly based upon, for example, who is funding it? 

Have you found in your experience that sometimes that comes into 

play where the quality of the study is critical? For example, it 

might be a university, it might be a private foundation or it might 

be industry itself looking at it. 

Dr. GRAY. I think that is irrelevant and prejudicial. 

Mr. STEARNS. If, for example, you are saying a university does 

it as opposed to a private foundation? 

Dr. GRAY. Yes, I think that there are excellent scientists in academia, government, and industry, and when our panel, the expert 

panel on BPA, reviewed studies we never considered who they 

worked for or who funded the study. We took each study on an individual basis and considered the quality of the experimental design and statistics, and if it didn’t meet minimum standards for experimental design and statistics, we determined that they were inadequate. So there were studies from academic, government, and 

industry labs that fell into that category, and those are the criteria 

we use to select studies for our review. We want it only based on 

high quality studies. 

Mr. STEARNS. Dr. Gray, the National Toxicology Program Center 

for Evaluation of Risks to Human Production expert panel sifted 

through many studies on BPA and disqualified some of them as 

part of its final assessment. What were the criteria by which these 

studies were omitted? Were studies funded by industry as well as 

from other sources disqualified for these reasons? 

Dr. GRAY. Well, the criteria that the expert panel used was—in 

terms of experimental design, did they have a concurrent control 

group? Did they properly analyze the data and control for the effects that they should have? If they didn’t use appropriate statistics 

then the conclusions of the study might be invalid in that they 

would think that there is a low dose effect of bisphenol-A when in 

fact this is random variation, so you can’t interpret that study, and 

so we didn’t include those. But the funding, as I said, the funding 

source was not considered. 

Mr. STEARNS. Dr. Alderson, is there anything you would like to 

add to that? 

Dr. ALDERSON. Well, I think Dr. Gray has summarized how we 

at FDA view all data. When a product comes to FDA, we ask the 

sponsor to demonstrate the safety of that product, in this case, a 

food additive, and also the utility of that product. So the burden 

is on the sponsor to make their case, and they are expected to 

74 

present all the data available on this particular subject, whether it 

is data they have generated themselves, whether it is data in the 

literature or from other sources that they may have access to. That 

is the package of information that FDA receives on basically all the 

products we regulate, not just food additives and in this case food 

contact materials, so that is a standard we look at for basically everything we do. 

On top of that, our scientists themselves go to the literature and 

see what they can find on their own. For food contact materials, I 

must tell you that one out of every four applications that comes to 

FDA for approval is ultimately withdrawn by the sponsor because 

the sponsor cannot show that it is safe. The burden is on the sponsor. 

Mr. STEARNS. Thank you, Madam Chair. 

Ms. SCHAKOWSKY. Thank you. Congresswoman DeGette from 

Colorado. 

Ms. DEGETTE. Thank you very much, Madam Chair. I want to 

follow up on a couple of questions some of my colleagues asked. 

First of all, Madam Chair, I would ask unanimous consent to put 

my opening statement into the record. 

Ms. SCHAKOWSKY. Without objection, so ordered.[The prepared 

statement of Ms. Degette follows:] 

STATEMENT OF HON. DIANA DEGETTE

Thank you, Madame Chair, and thank you for holding this hearing on phthalates 

(pronounced THAL-ates) and bisphenol-A (pronounced bis-FEEN-ol-A) (BPA). Today’s discussion will help us take another step forward in improving the health of 

Americans, and particularly kids, across the country. 

We started this journey last year, when I’m sure everyone remembers hearing 

about toy after toy contaminated with excessive lead. Parents were rightfully scared 

that toys, seemingly harmless play-things, could actually be deadly. 

Parents should take heart, though, because Congress is taking action. The House 

and Senate passed bipartisan legislation to address this problem of dangerous toys 

and strengthen the relevant regulatory agency, the Consumer Product Safety Commission (CPSC). I’m pleased to be a member of the Conference Committee working 

out the differences between the two bills, and we hope to see a bill enacted into law 

quickly. 

Unfortunately, our work is not done. Lead is not the only harmful substance 

found in consumer products, particularly dangerous to infants and children. 

Phthalates and BPA pose distinct health risks and ones which the Federal Government needs to address. 

Phthalates constitute a variety of compounds and are used in a diverse range of 

products, from toys to cosmetics. They are most often used in plastics to keep them 

both sturdy and flexible. They are ubiquitous, so everyone is exposed, including children. 

The concern is that some phthalates act as endocrine disruptors, interfering with 

normal development. For example, in numerous animal studies exposure to some 

phthalates in the womb has been found to affect the development and function of 

male reproductive organs. One of the developmental abnormalities found is a risk 

factor for testicular cancer. 

There is also scary evidence from human studies. Some phthalates have been associated with premature female breast development, higher rates of pre-term birth, 

low male sperm count, and poor male sperm quality. One human study even showed 

a link between some phthalate metabolites and insulin resistance, a precursor to diabetes. 

Its clear that exposure to some phthalates for infants and young children is harmful and detrimental to their development. I’m proud to cosponsor legislation sponsored by Representative Hooley, H.R. 4030, to either ban or better regulate six dangerous phthalates. It mirrors steps taken already by the European Union (EU) and 

California. 

75 

BPA, the other topic for discussion today, is also used in plastics and as part of 

certain resins. Most relevant here, these plastics and resins appear in things like 

baby bottles, cans which have food or liquids, and food storage containers. 

Is BPA leaching out of these items and into our bodies? The answer is yes. Of 

the people examined by the Centers for Disease Control (CDC), 92 percent had evidence of BPA in their urine. 

Is this exposure harmful? While entities in Europe and Japan have found current 

expected exposure levels to BPA are safe, Canada recently came to the opposite conclusion. It has banned use in baby bottles and is working to otherwise reduce BPA 

exposure. 

As for domestic agencies, the FDA concluded in November of last year that the 

current use of BPA was safe. Thanks to the ongoing investigation by the Oversight 

and Investigations Subcommittee into BPA and its uses, we have learned that it appears the two studies the FDA relied upon were industry-sponsored. That would 

make the FDA’s conclusion suspect. I know the Subcommittee has followed-up with 

the FDA to understand how it reached its conclusion, and we await the FDA’s substantive response. 

Most significantly, the National Toxicology Program (NTP) at the National Institutes of Health (NIH) released a draft brief in April on BPA. Based on numerous 

and up-to-date scientific studies it found ‘‘some concern for neural and behavioral 

effects in fetuses, infants, and children at current human exposures [and] some concern for [BPA] exposure in these populations based on effects in the prostate gland, 

mammary gland, and an earlier age for puberty in females.’’ While its conclusions 

are based on animal studies, the NTP writes that ‘‘the possibility that [BPA] may 

alter human development cannot be dismissed.’’ 

Its our job in Government to protect the public health by removing from use even 

potentially dangerous products. The findings of the NTP should be a wake-up call. 

The possibility that BPA could be having such negative effects on the health of our 

children means we need to seriously consider taking some kind of action. I expect 

our witnesses today will help elucidate what actions we should take. 

Protecting our kids’ health and safety is our most solemn responsibility, and if 

they are being exposed to dangerous compounds the Federal Government needs to 

get them out of the marketplace right away. We showed last year with respect to 

lead that Congress can act quickly, and I’m sure we will show the same alacrity 

with respect to phthalates and BPA. 

Again Madame Chair, thank you, and I yield back the balance of my time. 

Ms. DEGETTE. Thank you. The first thing, Dr. Babich, is I was 

listening to your testimony about how certain types of products for 

children, products that they suck on a lot like pacifiers and so on, 

phthalates have voluntarily been removed from those products by 

the manufacturers, is that correct? 

Dr. BABICH. Correct. 

Ms. DEGETTE. And when were those products—or when were 

phthalates removed from those products? 

Dr. BABICH. About 1999, early 1999. 

Ms. DEGETTE. And upon what information did the manufacturers 

decide to withdraw the phthalates from those products? 

Dr. BABICH. Because in 1998 CPSC staff completed a preliminary 

report which said we don’t think there is a hazard or a risk from 

DINP but there were significant sources of uncertainty, and that 

is when they voluntarily withdrew DINP from those products. 

Ms. DEGETTE. Now, did the FDA have the authority or does the 

FDA have the authority today to ban DINP from other children’s 

products? 

Dr. BABICH. Well, FDA or CPSC? 

Ms. DEGETTE. I am sorry, CPSC. 

Dr. BABICH. We have the authority, but there are a number of 

findings that the Commission has to make before they can ban. We 

have to show that there is an unreasonable risk. We have to show 

that there is no voluntary standard that adequately addresses the 

76 

risks. We have to also apply the least burdensome regulatory action, in other words, a ban is the most severe regulatory option, 

and we would have to show that labeling or some type of a standard would not be sufficient to address the hazards. 

Ms. DEGETTE. So it would be many steps that—— 

Dr. BABICH. It would be many steps and—— 

Ms. DEGETTE. And given the—I am sorry. I have limited time. 

Given the scientific data that all four of you gentlemen have been 

talking about, in your opinion would there be sufficient data to 

have ordered a ban? 

Dr. BABICH. No. No way. 

Ms. DEGETTE. At that time, and there wouldn’t be now in your 

opinion? 

Dr. BABICH. And there wouldn’t be now. 

Ms. DEGETTE. So here is my question, though, based on some 

preliminary data. Back in the late 1990s these manufacturers voluntarily took DINP out of certain toys but not other toys. Now, I 

am a parent, and I can tell you that my children when they were 

infants sucked on a number of other toys, so why hasn’t this substance been removed? I can understand them removing it—is it a 

risk benefit analysis by industry or what? 

Dr. BABICH. First of all, their reasoning—it is probably more 

than one reason, and concern about their products, but the reasoning for those particular products is that they are intended to go 

into the child’s mouth. 

Ms. DEGETTE. Yes, but you would agree with me—— 

Dr. BABICH. But it is backed up by an observational study. Children’s mouthing, when we took a careful look at children’s mouthing, we thought we were going to find hours per day. The things 

children mouth on most is their fingers. Second is pacifiers, and everything after that is relatively minor. Yes, children put literally 

everything you could imagine in their mouth but for insignificant 

frequency and duration. 

Ms. DEGETTE. Let me follow up on that because I was interested 

in one of the findings, and I was wondering how the Consumer 

Hazard Advisory Committee was able to conclude that kids would 

have to mouth toys with DINP for 75 minutes to have concerns 

about exposure. How did you come up with that standard? 

Dr. BABICH. Well, they worked backwards. They said if you are 

exposed to this much—this much DINP comes out of the product 

per minute, and of course we had limited data at that time, but 

taking that information and knowing what the acceptable dose is, 

they worked backwards and said you would have to mouth for 75 

minutes a day to exceed the acceptable dose. 

Ms. DEGETTE. There was an extrapolation of the data. Just one 

last question, and maybe someone else can answer it if you can’t. 

You had said that even though these phthalates were not found to 

be dangerous, the European Union banned them. Does anybody 

know why they banned them if the studies have shown that they 

are not dangerous? 

Dr. BABICH. Well, you know, they have this precautionary principle which came up in those discussions, but really I can’t say for 

certain exactly why. 

77 

Ms. DEGETTE. And they have a different regulatory structure. 

They don’t have to go—— 

Dr. BABICH. It is a different system. 

Ms. DEGETTE. Excuse me. They don’t have to go through all of 

the steps that the CPSC would have to go through to ban. 

Dr. BABICH. Correct. 

Ms. DEGETTE. Thank you. 

Ms. SCHAKOWSKY. Thank you. The gentleman from Pennsylvania, Mr. Pitts. 

Mr. PITTS. Thank you, Madam Chair. Dr. Babich, in your opinion, should I or anyone else who is bottle feeding a baby throw out 

our BPA bottles specifically because the BPA in the bottle is poisonous to the child? 

Dr. BABICH. Well, of course the infant bottles are not in our jurisdiction. They are under FDA’s jurisdiction. However, based on the 

NTP report I don’t have any reason to think that you should stop 

using them. 

Mr. PITTS. Dr. Alderson, do you want to comment? 

Dr. ALDERSON. I can’t add much to what Dr. Babich just said. 

That is FDA’s current position, that based on the information that 

we are continuing to review at this time, we do not see a need to 

change baby bottles and go to plastic. We do recommend you follow 

the directions of those glass manufacturers though. 

Mr. PITTS. Anyone else like to comment? Dr. Gray, you participated in the NTP’s expert panel review of BPA science, and the expert panel’s findings and recommendations document is distinct 

from the NTP’s draft document. The NTP’s draft is also different. 

Can you please describe the differences and how often does the 

NTP ignore the recommendations of its expert panels? 

Dr. GRAY. Well, I do have in my written testimony, I have a table 

on page 14 where I tried to compare the end points that we ruled 

on and our levels of concern and the ones of the NTP brief so this 

is my interpretation. But of the majority of the areas, we agreed 

on the levels of concern, and there were three areas where they 

had elevated the levels of concern where we had minimal or negligible. They elevated it to the level of some for the mammary 

gland, the prostate gland lesions and the age of puberty in females. 

I think of several hundred papers that represents a minor disagreement on less than 10 publications, and it is not a major discrepancy. It is not like we said it had negligible concern, and they said 

it had serious concern. 

I also think that my interpretation of the final outcome would be 

the same is that their final decision was that there was some concern, and there was limited evidence of low dose effects of 

phthalates, and that is based on four end points. And I think it 

would have been the same if they hadn’t elevated because we had 

some concern for neural behavioral effects based on limited evidence. So Dr. Bucher can clarify if I am wrong about that. So as 

to how often they ignore the expert panel, my guess would be that 

they never ignore the expert panel, but they do have the right to 

consider new data and re-evaluate the data. And they might even 

differ in their interpretation with the expert panel. 

Mr. PITTS. Dr. Bucher, do you want to speak to that? 

78 

Dr. BUCHER. Yes, I would agree that we, in fact, never ignore our 

experts, and, in fact, in the case of BPA, there is enormous, emerging literature. Over 400 studies have been published since the time 

the first expert panel report came out in April of last year, until 

now. So we have taken into consideration new information. We 

have taken into consideration literature that we gleaned from the 

public comments that we received in response to the expert panel 

report concerning clarifications, and in almost all cases we have 

used the same key studies that were considered of high utility by 

our expert panel in reaching our conclusions. So I would agree with 

Dr. Gray that these are rather minor differences actually, in interpretation. 

Mr. PITTS. Can you please define what is meant by repeatability 

of results, and why it is important in scientific studies if one’s results cannot be repeated, what does that mean for the findings? 

Dr. BUCHER. Well, repeatability of results, there are several different interpretations of that. The legal interpretation is that there 

is sufficient experimental design that is articulated in the reports 

that if someone wanted to repeat that study they could, in fact, repeat that study. Many of the studies that we have looked at with 

regard to BPA have been academic studies done in laboratories according to very precise techniques that they have developed, and 

they are in fact somewhat difficult to repeat exactly in other laboratories if they don’t have access to that same distinct technology. 

However, when we looked at repeatability of the BPA literature 

what we looked at was repeatability of general end points that 

were observed in studies that were designed similarly but not necessarily identically, and in other instances one needs to look at the 

guideline studies or the traditional safety assessment studies as 

well. In many cases those studies are large, but they are not repeated so repeatability of literature has a lot of considerations to 

go along with it with regard to looking at a large body of literature. 

Mr. PITTS. Are there any sort of official or widely accepted standards regarding scientific practices for the design and execution of 

a study specifically for a study on which you base a decision on 

whether or not to ban a substance. Can you please explain the 

basic elements? What would be the practical effect if we were to 

disregard the use of these standards? 

Ms. SCHAKOWSKY. This will be the last question because we are 

over time. 

Mr. PITTS. Dr. Gray or either one. 

Dr. GRAY. Well, each regulatory agency does have test guidelines 

that they use for many different types of tests including these 

which we would call multi-generational tests and they do specify 

end points, numbers of animals, numbers of litters, and they are 

usually done under good laboratory practices assuring documentation of the chemicals and the dosing solutions. Those standards are 

included, I think, in almost all the industry studies that are submitted for risk assessment. The academic laboratories don’t use 

those kind of standards for several reasons, just one because they 

are quite expensive and resource intensive. 

Mr. PITTS. My time is up. Thank you, Madam Chair. 

Ms. SCHAKOWSKY. Thank you. Mr. Melancon. 

79 

Mr. MELANCON. Thank you, Madam Chair. Dr. Babich, the 

phthalate that has drawn some attention is DINP and it is manufactured in my district, so I got some concern with it. It is commonly used, heavy in molecular weight and very low migration 

rate, as I understand it. The Consumer Product Safety Commission 

denied a petition from the Environmental Defense Fund to ban 

vinyl toys made with DINP in 2003. Can you share with the committee the process and history on the Commission’s decision to 

deny the petition? 

Dr. BABICH. OK. The process is any citizen or group can petition 

the Commission if they provide sufficient data. It is docketed and 

the staff begins to work on it, and the Commission has to make a 

decision as to whether to grant or deny the petition. If the petition 

is granted, then we would begin a rulemaking process. In this particular case, we did a great deal of work to assess, to review all the 

literature on the health risks and to seek input from the CHAP 

and the NTP and other experts. We did experimental work to assess the exposure and presented our results to the Commission. 

Now this petition wasn’t just about phthalates. It was about PVC. 

There were concerns about other additive chemicals, and that also 

figured into it, but we did our work. We made our recommendation 

to the Commission and the staff recommended that there was no 

need to grant the petition and the Commission agreed and voted 

unanimously to deny the petition. 

Mr. MELANCON. The Consumer Product Safety Commission spent 

4 years studying the DINP and concluded that there is not demonstrated health risk from its use in toys. Scientists for the European Union spent 10 years studying DINP, and along with the National Institute of Health have reached similar conclusions about 

the safety of the DINP. Can you specifically cite government agency’s review and approval of any of the potential alternatives to 

DINP? 

Dr. BABICH. Well, we don’t have any approval over the products 

or chemicals prior to marketing. We are just beginning to look at 

the phthalate substitutes. I don’t think any of them is as well studied as the phthalates, and for some of them we found very little 

or no data relating to toxicity. 

Mr. MELANCON. How long have we been using phthalates? 

Dr. BABICH. Probably long before I was born. I honestly don’t 

know. They have been around a long time. They probably pre-date 

the regulatory agencies represented here. 

Mr. MELANCON. But to an extreme or to a large amount, when 

you and I were younger, was it just a minor amount of use or is 

the—— 

Dr. BABICH. I honestly don’t know. As for example, building materials, you know, vinyl is somewhat replacing aluminum and that 

sort of thing, so, that may mean increased use of these chemicals. 

Automobiles have more and more plastics, and they are looking for 

lighter things, so, the market place is complicated, and I am not 

qualified to talk about that. 

Mr. MELANCON. So they told us to quit using galvanized pipe 

with lead because of the concern with lead. At least I think it was 

galvanized pipe or other fixtures, and now we are looking at doing 

away with PVC, is that where we are going? 

80 

Dr. BABICH. Well, you know, that is—— 

Mr. MELANCON. Getting away from it? 

Dr. BABICH. That is EPA’s jurisdiction, but my understanding is 

that most building codes don’t allow PVC in the water supplies. 

Mr. MELANCON. My time has about run out. Thank you, Madam 

Chair. 

Ms. SCHAKOWSKY. Mr. Terry. 

Mr. TERRY. Thank you, Madam Chairman. I have got three 

young boys, and all of our doctor friends told my wife to breast 

feed, and as I hear one of the concerns is about estrogenic bleaching. I would like to know approximately, and why don’t I give this 

to Dr. Gray first and if there are other folks up here that would 

like to add in, but approximately how many estrogenic compounds 

are there in breast milk? 

Dr. GRAY. I am not going to give you a specific number, but I can 

tell you there are estrogens, natural estrogens from the mother, 

and many other hormones and growth factors naturally in breast 

milk and in cow’s milk. And I don’t know, I think there are some 

indications that those are beneficial early in birth, and the growth 

factors in prolactin and things like that may be important in neonatal development. So there are estrogens there. There are quite 

a few publications that have looked at the levels of estrogens and 

other hormones in breast milk and in cow’s milk, but the levels of 

estrogen fluctuate with the cycle or in cows whether they are pregnant or not. So I think—— 

Mr. MELANCON. Are there estrogenic properties or estrogens in, 

I am sorry, in—I just lost the word, and baby bottles—I am sorry, 

in the milk that is powdered form that you would put into a bottle. 

Formula, thank you. My goodness. We are only a few years out 

from that too. Luckily, I didn’t have to get up all night. 

Dr. GRAY. I can’t personally answer that because I don’t know 

the answer. If anyone else knows that. 

Mr. MELANCON. Well, what are the difference between what 

would occur naturally through breast feeding and would could 

occur from the bottle? 

Dr. GRAY. I think that is an interesting question, and it seems 

to me that what we would really like to know is sort of a mass balance of all of the estrogens the fetus is exposed to and identify the 

sources and see how much is any particular environmental estrogen or contributing to that exposure. So is the bisphenol-A leaching 

from the baby bottle contributing at all to the daily body burden 

or is it insignificant, and I don’t think we have that information 

but it would be a valuable way to approach the situation. It is noteworthy that in humans unlike rats the estrogen levels are quite 

high in pregnancy in the mother. 

Mr. MELANCON. Interesting. Of the totality of the research that 

has been done, and there has been a lot of discussion about the 

methodology and repeatability, none of it is focused on the differences between the estrogen, if any, between natural breast milk 

and formula and from the plastic of the bottle? 

Dr. GRAY. There is a lot of literature and research on breast milk 

and its obvious benefits, and there is a lot of research on cow’s 

milk, and there are actually quite a few publications citing concerns about long-term consumption of cow’s milk throughout life 

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because of the hormones and things like that which are a data base 

of uncertain stream. 

Mr. MELANCON. Anybody else want to get into this discussion? 

Dr. GRAY. There is soy formula. Don’t forget soy formula. That 

has got phyto-estrogens in it. 

Mr. MELANCON. You have to put something in the baby bottle. 

Dr. GRAY. Yes. 

Mr. MELANCON. Thank you. 

Ms. SCHAKOWSKY. Let me just say that the record will be open 

for 30 days. Witnesses are invited, if they wish, to add additional 

materials and members may submit questions that I hope the witnesses, I expect the witnesses, will be willing to answer. So I want 

to thank you for your testimony and for your expertise. I appreciate 

your coming. Our second panel of witnesses. First let me introduce 

and apologize to Ms. Stanley. The identification says Mr., but it is 

obvious to everyone, and we do apologize for the mistake, Marian 

K. Stanley, Senior Director at the American Chemical Council. Ms. 

Stanley holds an MBA in pharmaceutical chemical studies and a 

BS in chemistry. She currently manages the Phthalate Esters 

Panel at the American Chemical Council, and is the panel’s legislative coordinator. Dr. Ted Schettler is Science Director at the 

Science and Environmental Health Network. Dr. Schettler has 

served on advisory committees of the Environmental Protection Administration and National Academy of Sciences. Dr. Schettler is coauthor of Generations at Risk, Reproductive Health and the Environment, and In Harms Way, Toxic Threats to Child Development. 

Dr. Calvin Willhite is a toxicologist for the State of California’s Department of Toxic Substances Control. He also serves on the National Advisory Committee of the U.S. Environmental Protection 

Agency for acute exposure guideline levels. And Stephen Lester is 

Science Director at the Center for Health, Environment and Justice. Mr. Lester directs the Technical Assistance Program at the 

Center for Health, Environment and Justice, which provides scientific and technical assistance to communities concerned about environmental health issues. His Master’s degrees are in Toxicology 

and Environmental health. And we will begin with Ms. Stanley. 

STATEMENT OF MARIAN K. STANLEY, M.B.A., SENIOR DIRECTOR, AMERICAN CHEMISTRY COUNCIL, ARLINGTON, VIRGINIA 

Ms. STANLEY. Good morning and thank you, Madam Chairperson, Ranking Member Whitfield, and members of the subcommittee, and thank you for this opportunity to testify. I am 

pleased to be here. Phthalates and bisphenol-A, or BPA, are not exactly terms that roll off the tongue, although of late they seem to 

be the focus of more and more American consumers who wonder 

whether products with these materials are safe. More than five 

decades of scientific scrutiny by institutions around the world support the continued use of phthalates and BPA in consumer products. Phthalates are vinyl plasticizers. They make shower curtains, 

floors, raincoats, and other household items soft and flexible. They 

keep vinyl toys soft and flexible so they don’t break into small 

sharp pieces that can be easily swallowed, and they are used in 

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non-consumer products like IV tubing and blood bags, helping to 

save lives. 

BPA is used primarily to make clear shatter resistant 

polycarbonate plastic and epoxy resins. For example, BPA is used 

to make bicycle and football helmets, eyeglass lenses, and baby bottles and sports water bottles. Epoxy resins are widely used as coatings to protect metals from corrosion. For example, as the coating 

inside most metal cans epoxy resins protect the safety and integrity 

of canned foods and beverages. Over the last 18 months, media reports have referred to a handful of studies that attempt to link 

phthalate and BPA exposure to adverse health effects. We are here 

today, Madam Chairperson, to provide a more complete picture to 

help put the public’s mind at ease. 

Let us first talk about phthalates and the numerous government 

agency assessments that found their use in consumer products is 

safe. In a 2001 safety assessment of vinyl toys softened with 

phthalates, the Consumer Product Safety Commission stated that 

there is, and I quote, ‘‘no demonstrated health risk to children from 

the phthalate most commonly found in toys, DINP.’’ CPSC added 

that there is, and I am once again quoting, ‘‘no justification for 

banning the use of the phthalate.’’ 

The National Toxicology Program had similar findings regarding 

DINP. The NTP found minimal concern regarding this phthalate, 

and the Centers for Disease Control and Prevention has tested 

thousands of Americans for evidence of exposure to phthalates. The 

CDC data shows that average human exposure is far below levels 

set by EPA as protective of human health. So there you have three 

U.S. government agencies finding that phthalates are being used 

safely in both consumer and non-consumer products. These findings have been mirrored by international agencies. For example, 

the European Chemicals Bureau stated that the phthalate used in 

toys is, and once again I am quoting here, ‘‘unlikely to pose a risk 

even for newborns.’’ 

As to why the EU parliament opted to ban phthalates in some 

children’s products despite its own agency’s finding of safety, it appears that politics, not science, drove that decision. Turning next 

to BPA, in the past 2 years comprehensive scientific assessments 

from the European Union, the U.S. National Toxicology Program, 

Health Canada, NSF International, and the European Food Safety 

Authority have all been undertaken, and these assessments support the continued safe use of consumer products containing BPA. 

Very recently, the FDA said we believe there is a large body of evidence that indicates that FDA-regulated products containing BPA 

currently on the market are safe, and that exposure to levels of 

BPA for food contact materials, including for infants and children, 

are below those that may cause health effects. 

Recently, the Canadian government for purely precautionary reasons proposed to ban polycarbonate baby bottles. However, their 

scientific report concluded that research tells us the general public 

need not be concerned. In general, most Canadians are exposed to 

very low levels of bisphenol-A, and it does not pose a significant 

health risk. In conclusion, I want to state that the American Chemistry Council understands that the public wants to be assured that 

the products they use are safe and have been evaluated using the 

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best science. And we agree in the case of phthalates and BPA consumers can confidently rely on rich bodies of safety data and the 

comprehensive assessments from experts in the U.S. and around 

the world. Thank you again for this opportunity to address the subcommittee. I am prepared to answer your questions regarding 

phthalates, and my colleague, Dr. Steve Hentges, who is here, is 

available to answer your questions regarding BPA. Thank you. 

[The prepared statement of Ms. Stanley follows:] 

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Ms. SCHAKOWSKY. Thank you. Dr. Schettler. 

STATEMENT OF TED SCHETTLER, M.D., M.P.H., SCIENCE DIRECTOR, SCIENCE AND ENVIRONMENTAL HEALTH NETWORK, ANN ARBOR, MICHIGAN 

Dr. SCHETTLER. Thank you, Madam Chair, members of the committee. Thank you for the opportunity to comment today on the 

safety of phthalates and bisphenol-A. My name is Ted Schettler. I 

am a physician. I have both a medical degree and a Master’s in 

public health with training in toxicology and epidemiology, as well 

as the traditional medical sciences. I participated in an investigation of phthalate exposures in infants in two hospitals. I have published papers and monographs addressing phthalate exposures and 

toxicity. I am currently the Science Director of the Science and Environmental Health Network. I have provided you with some written comments, and I will briefly summarize those now. 

The chemicals that we are discussing today are in the bodies of 

virtually every American. They are in fetuses, infants, and children. Health impacts linked to these chemicals are determined 

from animal testing and to a limited extent in humans, are among 

those that are prominent in people today, so today’s topics are of 

obvious public health concern. First I will comment on phthalates. 

People in the general public are regularly exposed to mixtures of 

phthalates because of their widespread use in consumer products 

and general environmental contamination. Some individuals are 

exposed at much higher levels than others. Phthalates cross the 

placenta and the developing fetus is also exposed. Members of the 

phthalate family of chemicals have both similarities and differences 

in their chemical structures. Some phthalates have enough in common to cause similar toxic effects. 

This means that when we estimate risks, we need to consider 

phthalate exposures in the aggregate, not simply risks associated 

with single chemicals from single sources. The developing male reproductive tract is particularly vulnerable to phthalates. Exposures 

in laboratory animals, as we have heard, cause a variety of malformations, including hypospadias, which is a birth defect of the 

penis with increasing incidence in baby boys in birth defect registries in the United States, undescended testes, and reduced 

sperm counts. At least six different phthalates interfere with normal testosterone production. That helps to explain how they alter 

reproductive tract development. When they are studied in mixtures, their doses are additive. 

This is a critical issue for public health protection. People are not 

exposed to single phthalates, but rather to mixtures. We need to 

think about that when drawing conclusions about risk. Some people are exposed to single phthalates at particularly high levels. In 

our study in two Boston hospitals, for example, we determined that 

some infants were exposed to DEHP from medical devices at levels 

in excess of FDA’s tolerable intake. When exposures are considered 

in the aggregate, as they should be for a subset of these chemicals, 

the number of people with excessive exposure is much larger. Studies of phthalates in humans are limited although evidence consistent with impacts at current exposure levels is beginning to accumulate. 

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For example, a study of baby boys found a correlation between 

maternal exposures to four different phthalates and altered genital 

development. We don’t know what the implications of these findings are for future health of reproductive success of these boys but 

in laboratory animals a shortened ano-genital distance, which is 

what is seen in these children, is often predictive of compromised 

reproductive success in adulthood. Phthalates are also linked to reduced sperm count or sperm quality in men studied and in infertility clinics. A study in Denmark found altered sex hormone ratios 

in boys whose mothers had higher levels of some phthalates in 

their breast milk. There are other health effects that haven’t been 

mentioned today linked to phthalates in building materials and 

household furnishings, including asthma, other respiratory illnesses, and allergies. 

Let me conclude with a few comments about bisphenol-A. There 

are different divergent opinions about health risks associated with 

this chemical, and I want to make several points. First, studies 

from the CDC undeniably show that exposure to bisphenol-A is 

widespread in the general population. Second, in addition to the 

biologically inactive metabolite of bisphenol-A, the active form is 

also regularly detectable in the blood of people. Third, fetuses and 

infants have markedly reduced capacity to transform the active 

form of bisphenol-A into the inactive form that is excreted in the 

urine, and for that reason fetuses and infants are at particular risk 

of prolonged exposure. 

Fourth, based on a large scientific data base, the committees that 

we have heard about earlier today have enumerated a number of 

health risks, but I want to focus on just a couple of them to finish 

up here. We have heard about the neural behavioral changes, 

which, by the way, do not just occur by injecting the chemical into 

the brain, but happen in animal studies where the animals were 

exposed orally at levels that are approximately equivalent to what 

humans are exposed to, and we have heard about others as well. 

But animal testing shows that low level bisphenol-A during fetal 

development modifies the development of the prostate gland and 

breast, permanently altering their disease architecture. Moreover, 

these architectural changes predispose the prostate and breast to 

later disease, including cancer. 

In some cases, these changes are themselves pre-cancerous. From 

a public health perspective, this is a serious concern. If these same 

tissue alterations occur in people, and the presumption ought to be 

that they do unless it is shown otherwise, we are faced with a troubling reality. That means that virtually all fetuses and infants in 

the United States are exposed to a chemical at levels that may increase the risk of prostate or breast cancer years later. Today’s patterns of disease and disabilities prominently include prostate and 

breast cancer, diabetes, early onset of puberty in girls, behavioral 

abnormalities in children, infertility, and birth defects of the reproductive tract, including hypospadias. 

Each of these conditions has been linked in some way from the 

literature that you have heard about today to phthalates or 

bisphenol-A. Whereas, there are many different interpretations of 

some portion of the scientific database, it is undeniable that all 

Americans are exposed to these chemicals. So I urge you to think 

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about this from a public health perspective and ask what amount 

or strength of evidence we should require before taking action to 

reduce or eliminate exposures, particularly in vulnerable populations. This is a public policy decision which should be informed 

by good science, but also by values and common sense. Do we need 

to wait for irrefutable proof of harm? The limits of epidemiologic 

research will always make it difficult to tease out some cause and 

effect relationships even when they exist. It is particularly difficult 

when the entire population is exposed to the chemicals of concern. 

Policymakers need to decide when evidence is sufficient to act 

even in the face of uncertainty; otherwise, we miss important opportunities for the primary prevention of disease and disability. 

Thank you very much for the opportunity to comment today. 

[The prepared statement of Dr. Schettler follows:] 

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Ms. SCHAKOWSKY. Dr. Willhite. 

STATEMENT OF CALVIN WILLHITE, PH.D., STATE OF CALIFORNIA, DEPARTMENT OF TOXIC SUBSTANCES CONTROL, 

BERKELEY, CALIFORNIA 

Mr. WILLHITE. Good morning, Madam Chairman and committee 

members. 

My name is Calvin Willhite, and I am a toxicologist with the 

State of California. However, none of my written or verbal testimony should be interpreted as representing that of the State of 

California. I am here today on behalf of NSF International, which 

used to be called the National Sanitation Foundation, and their 

health advisory board. Today I am going to speak about bisphenolA, a chemical that some people consider dangerous, but first I 

would like to start with a short story. 

All parents tell their children that there are no such things as 

ghosts, but one night at Boy Scout camp the Scoutmaster told us 

a story about something that was in the Okefenokee swamp, and 

we 10-year-old children believed that. 

Developmental toxicology has many ghosts and many villains. An 

example of a ghost is Bendectin, a drug used for more than 30 

years to control nausea and vomiting in pregnant women. Sensational press reports and over 300 lawsuits alleged that it caused 

birth defects. Subsequent studies proved that was absolutely false. 

An example of a villain is the Japanese Nitrogenous Fertilizer 

Company, who discharged mercury into Minamata Bay and 

poisoned at least 800 people, caused fetal encephalopathy, and 

killed at least 100. 

So is bisphenol-A a ghost or is it a villain? Bisphenol-A is the 

substance used to make polycarbonate plastic and epoxy resins. 

From this plastic we have all sorts of products, including beverage 

containers and bicycle helmets. The resins are used to line food 

cans. 

Is bisphenol-A dangerous? All scientists agree that bisphenol-A 

has estrogen-like activity. They just disagree about how powerful 

it is. Some contend it causes toxicity at very low doses. Others find 

it causes no such effects even at high doses. These differences are 

mainly due to how the chemical is given to lab animals; that is, 

whether it is injected or given by mouth. Since nearly all human 

exposure comes from food, and since all regulatory agencies agree 

that if humans are exposed to a chemical by food, the compounds 

should be given orally. In our work at NSF, we used the laboratory 

studies that gave bisphenol-A orally to derive a safe upper limit of 

exposure for bisphenol-A in drinking water. Therefore, what we 

now need are safe limits to control the levels of bisphenol-A in infant formula, food, and beverages. We already have the National 

Academy of Sciences methods for establishing those limits. So to 

discuss the danger of chemicals like bisphenol-A, we should use 

those methods. 

People have their own opinions about how dangerous bisphenolA might or might not be but a personal opinion doesn’t matter. To 

answer the question whether bisphenol-A is harmful or not, we 

need evidence-based toxicology to define what is called the margin 

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ready established a safe, upper limit of exposure for another endocrine disrupter. That chemical is named zearalenone. It is present 

in pastries, infant food, and even beer because zearalenone is produced by a fungus that grows on barley, corn, wheat, and rice. 

Zearalenone is hyperestrogenic. It is one-tenth as powerful as the 

natural estrogen in our body. By comparison, bisphenol-A is one fifteen-thousandths as powerful. 

How can we implement a ban on zearalenone? Does that mean 

a ban on donuts and beer? The answer is we couldn’t. Only after 

we define safe limits can we gauge the relative hazard or safety of 

exposure to zearalenone, bisphenol-A, or any other chemical. And 

by the way, a famous American once wrote: ‘‘There is something 

fascinating about science. One gets such wholesale returns of conjecture out of such trifling investments of fact.’’ That famous American was Samuel Longhorne Clemens. Thank you. 

[The prepared statement of Dr. Willhite follows:] 

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Ms. SCHAKOWSKY. Mr. Lester. 

STATEMENT OF STEPHEN LESTER, SCIENCE DIRECTOR, CENTER FOR HEALTH, ENVIRONMENT AND JUSTICE, FALLS 

CHURCH, VIRGINIA 

Mr. LESTER. Madam Chair, distinguished members of the subcommittee, thank you for this opportunity to testify on the safety 

of phthalates and bisphenol-A in everyday consumer products. My 

name is Stephen Lester, and I am the Science Director with the 

Center for Health, Environment and Justice. CHEJ is a national 

environmental health organization founded in 1981 by Love Canal 

community leader Lois Gibbs. We assist people to fight for justice, 

empower them to protect their communities, and lead national environmental health campaigns. Phthalates are used to make PVC 

plastic toys and other PVC products soft and flexible. When children play with or chew on vinyl toys, phthalates can leach out of 

these products. 

As we have heard, phthalates have been linked to reproductive 

problems during development in both girls and boys. Safe or costeffective alternatives exist to make soft plastic toys without using 

phthalates. These alternatives include toys made out of bio-based 

plastics, polyethylenes, polypropylenes, and ethylene vinyl acetate. 

In addition, soft plastic toys have been made with non-phthalate 

plasticizers for years. For example, the Danish company Danisco, 

one of the largest manufacturers of food additives in the world, introduced a phthalate alternative for toys and other products that 

has been approved for use in both the EU and in the U.S. 

In response to the health hazards posed by phthalates in children’s toys, the European Union and many countries around the 

world have restricted the use of phthalates in children’s toys. Prior 

to the EU’s permanent ban, 15 countries from around the world 

also had banned phthalates in children’s toys. The U.S., however, 

is one of the few developed countries with no government limits on 

phthalates in toys aimed at young children. Since the EU banned 

phthalates from toys, toy sales have increased at a pace that exceeds the growth in the United States. Ninety-five percent of all 

toys sold in the U.S. are manufactured outside of this country, 85 

percent in China. 

As a result, amendments such as the Feinstein amendment, 

which has been introduced, won’t disrupt the marketplace in the 

U.S. because we are not exporting or manufacturing very many 

toys. Many leading toy companies and retailers are already restricting phthalates. Ten years ago, Mattel, Hasbro, and 

Toys‘‘R’’Us, three U.S.-based, multi-national companies who represent 60 percent of all U.S. toy sales, announced they would reformulate their toys globally and take out phthalates to meet the EU 

toy standards. By early 1999, as we heard earlier, a large number 

of companies stopped making, I guess it was rattles, teethers, and 

pacifiers in the U.S. voluntarily. Many of these same companies 

now are also committed to phase out the production of all toys that 

include phthalates. 

Retailers are also removing toys made with phthalates from their 

shelves. European retailers and manufacturers have been phasing 

out phthalates and other toxic chemicals in toys for many years. 

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We are now seeing a similar movement here in the United States. 

Over the past 2 years, some of the largest retailers in the U.S., including Wal-Mart, Target, and Sears Holdings have announced 

policies to phase out and restrict toxic chemicals such as phthalates 

in children’s toys and in products they sell. Phthalates are also 

being phased out by leading hospital and cosmetic companies 

across the country. Over 100 health care institutions and nearly 

1,000 cosmetic companies have pledged to phase out their use of 

toxic chemicals such as phthalates. 

Bisphenol-A is used in the manufacture of consumer products 

made out of polycarbonate plastic, which include baby bottles, reusable water bottles, and infant formula containers. Studies conducted on laboratory animals and cell cultures have linked low 

doses of BPA to obesity, diabetes, thyroid disease, breast, and prostate cancer, and other illnesses. In April of this year, the federal 

government of Canada proposed designating BPA as toxic under 

the Canadian Environmental Protection Act, which will lead to a 

ban on BPA baby bottles and other restrictions. In response, there 

has been a major market movement and backlash away from BPA 

among baby and water bottle companies, as well as retailers in 

both the U.S. and Canada. This includes Wal-Mart, CVS, 

Toys‘‘R’’Us, Playtex, Sears Canada, Home Depot Canada, and many 

other companies. At the state level, last October California became 

the first state in the Nation to ban the sale of kids toys with 

phthalates. Washington State also did this this past year in April. 

In total, a dozen states introduced legislation to ban phthalates 

or BPA from kids’ products or child care articles over the past year. 

These new market trends and the legislative activity in the state 

should be reinforced by federal legislation. This important issue 

should not be left only to individual states to legislate. Congress 

has the opportunity and the responsibility to provide all our children with the same level of protection afforded now to children in 

only a few states. I respectfully urge the subcommittee to do everything in its power to insure the House includes a ban on phthalates 

in children’s toys and child care articles and the Consumer Product 

Safety Commission reform pack it will be voting on later this 

month. 

Lastly, I understand that legislation has been introduced today 

by Representative Markey to ban BPA in food and beverage containers, including baby bottles. This legislation should also be supported. I thank the Committee for this opportunity to testify, and 

I will try to answer any questions you have. 

[The prepared statement of Mr. Lester follows:] 

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Ms. SCHAKOWSKY. Thank you. We will begin our questioning 

now, and I will begin with myself for 5 minutes. Ms. Stanley, you 

state that it is a myth that phthalates are used for teething rings, 

and yet Mr. Lester, in your written testimony I was listening for, 

I am not sure you said it, states that phthalates are used in teething rings, so now that we have both of you here, I am wondering 

if you could first state how you know that, what is used instead 

of phthalates. 

Ms. STANLEY. Certainly, I can answer that question. There have 

been a couple of voluntary agreements that the toy industry has 

had with removing some phthalates. The first was in the early 

1980s, and that was DEHP. There was the threat of rodent liver 

cancer. There was a voluntary agreement, now part of an ASTM 

standard, that limited that phthalate to 3 percent in teethers, rattles, and pacifiers. 

Ms. SCHAKOWSKY. Is that only for U.S. manufacturers? 

Ms. STANLEY. Yes. That is for U.S. manufacturers. 

Ms. SCHAKOWSKY. So it could be imported. It could be in teething 

rings that are imported? 

Ms. STANLEY. I wouldn’t imagine that because I know that the 

toy industry association from my discussions with them has very 

strict standards, and they enforce those standards with their manufacturers overseas, particularly in Asia. Now the second part of a 

restriction was with DINP, and as Dr. Babich from CPSC discussed, that was in the late ’90s. Now I don’t know what has been 

substituted, but once the market shifts away, that shift will pretty 

much remain permanent. I have not had discussions with the toy 

industry association. I know they support the continued use of 

DINP because of all the reviews and their certainty that it is safe 

to use with children. 

Ms. SCHAKOWSKY. OK. Mr. Lester. 

Mr. LESTER. Well, I can’t speak to this specifically, but it is my 

understanding that because so many of the toys are imported now 

that there is no control or oversight over which of these contain or 

not contain phthalates. 

Ms. SCHAKOWSKY. OK. You do speak to it specifically in your testimony saying that among other things phthalates are used in soft 

PVC toys and other baby products such as teething rings, rubber 

duckies, and bath books. 

Mr. LESTER. Well, what I am referring to there is that these are 

products that are imported into the United States. It is my understanding that, yes, phthalates are included in these products. 

Ms. SCHAKOWSKY. OK. Let me ask another question. In former 

testimony, I think it was Dr. Babich saying that when testing how 

children actually mouth various things, it said that it was lower 

than expected, and that the greatest amount was on their fingers, 

and I am just wondering if there is the possibility of harm done because of sucking on their fingers and if anybody here has any data 

on that, whether it is transferable. Dr. Schettler. 

Dr. SCHETTLER. I published a paper on human exposure to 

phthalates from consumer products, and in the process of doing the 

research for that paper tried to wrap my head around figuring out 

where the phthalates come from, if anybody really knows. And as 

Dr. Gray mentioned in the previous panel, sometimes people are 

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identified with high levels but we don’t know where they came 

from because these chemicals are so ubiquitous. But one conclusion 

does seem to be gaining consensus in the scientific world, and that 

is that dust contamination with phthalates is probably an important pathway for children because of hand to mouth activity, and 

that is based on both doing dust analyses in homes and then measuring phthalate metabolites in the urine of children. 

You begin to see a correlation there that holds up for children, 

but not for adults particularly well, so the conclusion drawn is that 

general environmental contamination, dust contamination, and 

hand-to-mouth activity is an important exposure pathway, which 

then of course sets the stage for the sucking on the toy or the other 

sources. That DINP or whatever phthalate is coming from the toy 

is not coming into an empty child. A child already has a background level of phthalates. That is why this mixture conversation 

is important. 

Ms. STANLEY. And, Madam Chair, we do have data on the absorption of phthalates through both living rat skin and through 

human cadaver skin, and we know that DEHP in particular has a 

very, very low absorption rate. Additionally, in response to some reviews by the cosmetic ingredient review, an independent scientist 

did some work on the absorption of dibutyl phthalates through the 

nail bed because that phthalate isn’t really used in vinyl. It is used 

more in cellulosic type plastics, so we have got that data as well, 

which we would be happy to provide to you. 

Ms. SCHAKOWSKY. I would appreciate that. Given Dr. Bucher’s 

testimony that the National Toxicology Program maintains that 

BPA poses some concern, that is the mid-level of concern, to infants 

and children, will the American Chemistry Council revisit its position on the safety of BPA? 

Ms. STANLEY. I would like to refer that to my colleague, Dr. 

Hentges. 

Ms. SCHAKOWSKY. Would you introduce yourself? 

Mr. HENTGES. Sure. I am Dr. Steven Hentges. We are in the 

process of reviewing that report ourselves. In fact, I think as you 

heard earlier, there is a meeting tomorrow at which the NTP Board 

of Scientific Counselors will review that report as well. Once everything is finalized, we will certainly take a close look. One of the 

things we will be taking a very close look at is what additional research has been recommended. There is quite a bit that was recommended in that report. And, in fact, we have one study underway now. It is completely independent from the NTP report, but 

one study underway now that will address one of those scientific 

needs, so that is in particular one of the areas that we will take 

a look at very closely. 

Ms. SCHAKOWSKY. OK. Let me see if I have any time. I do. Oh, 

it is not. OK. I am out of time. Sorry. Mr. Whitfield. 

Mr. WHITFIELD. Well, I would also like to thank this panel of witnesses. Mr. Lester, I was reading an article on Forbes Magazine, 

and it said that the president of a company called Born Free came 

and talked to Children’s Health and Environmental Justice, a 

group of people from there. Is that the name of your organization? 

Mr. LESTER. Not precisely, no. 

170 

Mr. WHITFIELD. So it is not the same. Did he speak to your group 

at all? 

Mr. LESTER. No, he did not. 

Mr. WHITFIELD. Well, anyway in this article it talks about how 

he expressed concern about BPA and said that it included arsenic, 

for example, and as a result that and other information was ever 

convinced, whole foods and others to move away from BPA, and yet 

it is my understanding that there isn’t any entity anywhere in the 

world that has banned the use of BPA. Is that correct or is that 

not correct, Ms. Stanley? 

Ms. STANLEY. That is correct. 

Mr. WHITFIELD. But, Dr. Schettler, you and Mr. Lester, would I 

be inaccurate to say that you have real concerns about BPA, is that 

correct? 

Dr. SCHETTLER. I have real concerns about BPA for two reasons. 

First, because the exposures are ubiquitous in the population. 

From a public health perspective, that really wakes me up, and it 

wakes most people up. When you have population-wide exposures, 

and you have population-wide exposures in fetuses and infants, 

now you really start to pay attention from a public health perspective. Second, when you see these low dose effects that are showing 

up in the animal literature even though, as we have heard, there 

is uncertainty and disagreement about how to interpret the data, 

you still have from my perspective as a public health professional, 

I am quite concerned about that because if these effects are happening in people we have set the stage for an epidemic of disease 

that we are going to be living with for decades. 

Mr. WHITFIELD. Dr. Willhite, what do you think about BPA? 

Mr. WILLHITE. Sir, I think the question that you are probably 

asking in a shorthand way is, is BPA safe or not? That ought to 

be the kind of question—what it really boils down to is what we 

call the margin of exposure, and I am going to give you one example to illustrate what that is and will pick kids in daycare and at 

home that have been followed. The important thing to understanding about this is the larger the margin of exposure, the more 

comfortable you should be. For example, that is why we have like 

a drinking water limit, and then you can compare the results of 

your studies measuring it in drinking water with a margin of exposure. For myself, this is my personal opinion, I like to see at least 

a margin of exposure about 10 times lower than what my number 

is. Say if your drinking water maximum at that level, you don’t 

really want to be right at the number. You want to be a little bit 

less or hopefully a lot less. 

If we look at the drinking water number, the concentrations that 

have been measured around the world and in the United States, 

the margin of exposure there is between 200 and 300,000, so I 

wouldn’t worry too much about drinking water. Let us go over to 

our daycare kids, and these are kids that were living in Durham 

and Raleigh, North Carolina. The references are Wilson 2003 and 

2007. These authors accounted for the child’s total aggregate 

bisphenol-A exposure from all liquids and from all solid foods at 

home and at day care, and they included dust and soil. Average 

total daily ingested bisphenol-A was 0.043 micrograms per kilogram a day. Compared to the European, like the bench mark numVerDate Nov 24 2008 11:20 Oct 08, 2010 Jkt 037690 PO 00000 Frm 00176 Fmt 6633 Sfmt 6633 C:\DOCUMENTS AND SETTINGS\CWELLS1\HEARINGS\110-125 SCOM1 PsN: JIMC
171 

ber, the margin of exposure for North Carolina children ages 11⁄2

to 5 years is 1,162, and compared to the NSF oral RFD, they are 

a little bit different; the margin of exposure is 372. 

So what you want to please do in your considerations is to look 

at different margins of exposure and the one that you are going to 

want to focus on the most, and if it is safe for this particular group, 

that group is the smallest margin of exposure is for the premature 

infant given formula. But we need more accurate estimates on the 

real range of bisphenol-A exposures in that population because 

they vary for two reasons. One is the way they calculate exposure 

through bio monitoring. They measure the amount of metabolites 

in urine, and then back-calculate to what it was that you ate. The 

other is you go and you measure all the different kinds of foods 

there are, and you measure how much is in there. Then you figure 

out how much red chili pepper you eat, and how much of this or 

that or the other, and then they add them up. The problem, each 

has its advantages, each has its disadvantages, but when you are 

in a decisionmaking situation, the problem is that the uncertainty 

in the exposure estimate is off by 1,000. 

So now you are stuck with this uncertainty, and that is just how 

it is. But from the best data that we have, that is the most—that 

is the critical population you want to look at, and the others are 

on the order between 200 and 372 and nothing at all. 

Mr. WHITFIELD. Thank you. 

Ms. SCHAKOWSKY. Ms. Hooley. 

Ms. HOOLEY. Thank you, Madam Chair. Thank you for testifying. 

Dr. Schettler, I have a couple of questions for you. One is, you 

know, why does exposure to phthalates in toys and children’s articles matter? Isn’t the dose too small to worry about? Some of the 

witnesses today have argued that there is plenty of evidence to be 

concerned about kids’ exposures to phthalates, and other witnesses 

argue just the opposite. What, in your opinion, should be the role 

of policymakers when confronted with a lack of consensus within 

the scientific community and/or scientific uncertainty around this 

issue? 

Dr. SCHETTLER. Thank you for the question. There are really two 

parts to it. The reason that I am concerned about phthalates in 

toys is because of the aggregate exposure issue. I mean if you just 

take a toy and calculate the DINP, for example, as we heard that 

is leaching out and do a risk assessment based on that, that is one 

thing, but if you do it in a real world set of circumstances where 

children are already contaminated with other phthalates, but as we 

have heard other non-phthalate chemicals that act in an additive 

fashion, that is the real world risk assessment that we ought to be 

thinking about. That DINP from that toy is going into a context 

that is not clean. 

The other part of your question is a very interesting and important one, having to do with how do policymakers deal with uncertainty, and I think it is a very important thing to think about. We 

should think about necessity of products. We should think about alternatives to products, and we should think about how our policy 

decisions can actually drive us toward a safer material market. 

One of the things that struck me today is that we are being told 

that because we are ignorant about certain other plasticizers that 

172 

we ought to continue with the status quo. What this is really doing 

is rewarding ignorance. The fact that we have products on the market containing chemicals whose toxicity has not even been investigated is being used as a reason for maintaining the status quo 

with chemicals that we have concern about. 

We really ought to be formulating policies that are going to drive 

us to more information and to a safer, material market. So I think 

in this set of circumstances we have heard that there are alternative plastics, there are alternative materials as well as alternative plasticizers. We could pick out from this whole constellation 

of products that contain either bisphenol-A or phthalates and think 

about which ones that we might want to restrict in some way. I 

mean if you restricted bisphenol-A in baby bottles because dietary 

exposure is an important exposure and this is important for these 

infant kids, there are plenty other materials that you could make 

baby bottles out of that wouldn’t pose any of this risk because they 

don’t have materials that are leaching out in the same way. 

We have to think creatively about how to deal with uncertainty 

in a way that both doesn’t create new risks and also drives the 

market into safer material. 

Ms. HOOLEY. Thank you. I have a follow-up question. What do 

you think of the CPSC stating they just looked at DINP? 

Dr. SCHETTLER. The one that was described earlier today? 

Ms. HOOLEY. Yes. 

Dr. SCHETTLER. Well, again, I think that it was a traditional 

CPSC risk assessment that was based on the assumption that the 

child who is sucking on that toy does not have pre-exposure to any 

phthalates, and then they did an analysis and came up with their 

conclusion. But we know from the scientific literature that DINP 

does interfere with testosterone synthesis similar to the other five 

phthalates that have been mentioned, and although I would agree 

that it is not as potent as the others, it has been shown that it is 

additive. And so we need to do our risk assessments in a much 

more real world way where we are looking at the real context in 

which these children live when we are deciding about the additional hazard posed by this particular product under these circumstances. 

Ms. HOOLEY. Thank you very much. Dr. Lester, in your testimony you argue that alternatives exist to PVC toys softened with 

phthalates, but many members of this subcommittee have been visited by representatives of the toy industry that argue there are no 

alternatives, and kids will choke and die from chewing on or playing with hard plastics. I am confused. What has Europe been using 

in the last decade since their ban on phthalates in toys went into 

effect, and what are some of the alternatives to the phthalates we 

have been discussing today that can be used to make toys soft? 

Mr. LESTER. Well, there are alternatives on the market, and I 

think the European Union example is the best example of that because they have had this ban in place since 2005, and earlier a 

number of companies voluntarily moved away from it. And so they 

are selling toys over there, and they are doing quite well. They are 

selling more there than we are here. So there are alternatives, and 

some of these alternatives include some of the alternative plastics 

such as polyethylenes, polypropylenes. There is a whole new area 

173 

now of development in these bio-plastics that are using corn and 

other forms of natural components to create plastic. And so there 

are these alternatives. They exist. They can be used. There are also 

others that don’t use plasticizers at all. 

So I think there is a good track record of these alternatives, and 

I think you just have to look for them and you have to—and people 

are using them so there is a track record. 

Ms. HOOLEY. One quick follow up. The policy of restricting use 

of phthalates in toys, people have said would disrupt the U.S. market. Is this something we need to be worried about? 

Mr. LESTER. I am sorry. I didn’t hear the first part. 

Ms. HOOLEY. A lot of people say that if you don’t use phthalates 

in toys that it would disrupt the U.S. market, and my question is, 

is this something we need to be worried about? 

Mr. LESTER. I don’t think so. I mean it is important not to disrupt the U.S. market certainly, but given the small amount of toys 

at least that are made here in this country, 95 percent are imported, and there is no regulation on those coming in. So if we set 

a ban here on what the U.S. companies are manufacturing in this 

country or put restrictions on it, it won’t have very much of an impact unless it also applies to those toys being imported. 

Ms. STANLEY. Ms. Hooley, may I have a comment, please, on 

that. I might be able to shed some light here. One of the reasons 

that vinyl is a useful plastic is that it can be customizable, if you 

will, by the amount of plasticizer. And I have been on conference 

calls with small to medium toy industries. These aren’t the Mattels 

and the Hasbros of the world. These are the people who are designing prototypes of toys. These are the people who are making a 

small part because of this year’s fashionable doll they can provide 

a certain piece of it. And when the fashion changes, as it does yearly in the toy industry, they can quickly change to another part. I 

have heard medium-size manufacturers say we will have to stop 

making some parts because we don’t have the R&D because changing to an alternate plasticizer isn’t a one-to-one switch-off. 

You have got to change some stabilizers. You have got to change 

some other things. And so I have personally heard these folks say 

on the phone that is the impact of them. 

Ms. HOOLEY. Thank you. 

Ms. SCHAKOWSKY. Ms. DeGette. 

Ms. DEGETTE. Thank you. Well, just to reassure you, Ms. Stanley, if we ever did change the standard, we wouldn’t do it overnight. Congress can’t possibly move that quickly, so it would be 

some period of time for manufacturers to adjust. Mr. Lester, something you just said was really telling to me, and I think something 

we have to deal with as policymakers is it does—I mean we are all 

here to try to improve the lives of our constituents and consumers, 

and so the solution here really wouldn’t be just to ban the use of 

these substances in toys manufactured in the United States because as you point out, the vast majority of toys are now imported, 

and that is why we have to really think about the risk and what 

we are going to do in general. 

And that is, I think, why the large toy manufacturers, as I was 

fleshing out with the last panel with Dr. Babich, I think the reason 

the large toy manufacturers voluntarily stopped putting DINP into 

174 

toys is because they couldn’t sell their toys internationally and in 

other countries where they have stronger standards. And so don’t 

you think we would need to have stronger standards for all toys 

that are distributed in the United States, not just toys that are 

manufactured in the United States? 

Mr. LESTER. Oh, without question. The market has changed 

such. The global economy is such that it has to be—— 

Ms. DEGETTE. And what we are trying to think about globally in 

terms of our consumer product legislation that is in the conference 

committee right now is we are trying to think about how we structure our statutes to deal with the shifting markets where we have 

so many imports coming in. Dr. Schettler, I wanted to follow up on 

a couple questions Ms. Hooley was asking you about because it is 

hard for us as policymakers to grapple with scientific studies and 

differing conclusions. What you are saying is that these studies 

that the CPSC is relying on are really studies that were based on— 

that didn’t look at the environmental data of these children and infants, correct? 

Dr. SCHETTLER. That is correct. 

Ms. DEGETTE. And what you are saying is that there are other 

studies that you are relying on that when you look at the environmental factors there really were much more serious health hazards 

than the studies that the CPSC is relying on? 

Dr. SCHETTLER. Well, what I am saying is that I don’t make the 

assumption that the child, the theoretical child in the risk assessment, is empty of phthalates before sucking on the toy. 

Ms. DEGETTE. Now what about Ms. Stanley’s statement that the 

phthalates, at least certain types of them, do not in the industry’s 

opinion get absorbed through the skin? 

Dr. SCHETTLER. Well, I wasn’t commenting on skin absorption. I 

do have opinions about skin absorption, but I was just simply saying that we can take a sample of children and take urine from 

them and measure phthalates in them. The Centers for Disease 

Control has done this, so we know that children are contaminated 

with mixtures of phthalates in the real world. 

Ms. DEGETTE. OK. Not just through skin absorption. 

Dr. SCHETTLER. Not just through skin absorbtion. From all 

sources. 

Ms. DEGETTE. OK. I thought it was interesting, and I am thinking about this from a policy-making standpoint what Dr. Babich 

told me about, and actually this would be for you, Mr. Lester, as 

well, about what it would take for the Consumer Product Safety 

Commission to actually ban phthalates in these toys, and he went 

through all of the standards that we have at the CPSC. The industry did voluntarily leave DINP out, but my question is if you go 

through all of the CPSC standards and the current status of the 

scientific data, do you think that the threshold would be met under 

current law to have the CPSC ban these? 

Mr. LESTER. No, for the same reasons that Dr. Babich concluded. 

It is unlikely because the authorizing legislation is so onerous that 

you need to demonstrate significant evidence of harm and do a cost 

benefit analysis, and he named all the—— 

Ms. DEGETTE. Do you think these are the correct standards that 

we should be looking at, these substances and consumer products? 

175 

Mr. LESTER. No, clearly not protective of public health. 

Ms. DEGETTE. Do you think these standards are more protective 

of industry than they would be of consumers? 

Mr. LESTER. Well, they clearly protect the product and the product manufacturers. That is perhaps even what they were intended 

to do, but from a public health perspective the burden of proof is 

on the public or the legislature or the regulators to demonstrate 

harm, which is really not where it ought to be. Now the Food and 

Drug Administration in the pharmaceutical program has a different burden of proof and a different set of thresholds that they 

need, but not in the Consumer Product Safety Commission. 

Ms. DEGETTE. When were those CPSC standards promulgated? 

Was it in the original enacting legislation for the CPSC? 

Mr. LESTER. I would assume so, but I am not an expert on that 

legislation. 

Ms. DEGETTE. My time has expired, but I am wondering if you, 

Mr. Lester, Dr. Willhite, and Ms. Stanley, any of you would be willing to supplement your testimony with any recommendations you 

may have as to how we could modify the CPSC standards to be 

more in line with protecting consumers. Thank you. Thank you, 

Madam Chair. 

Ms. SCHAKOWSKY. I want to thank everyone. I would without objection just ask one more question of Ms. Stanley. Do you have any 

doubts about the safety of phthalates, and what would it take for 

you to be convinced that they are unsafe? 

Ms. STANLEY. Well, I have managed this group, and I have seen 

them through research. I am coming up on 19 years now, so I have 

seen a lot of research conducted. I have seen the industry work as 

hard to develop just data that doesn’t make it look any worse or 

any better at any of the phthalates. I wouldn’t be convinced because I know that they don’t bio-accumulate. I know that they have 

a very quick transit in the body. I know that they look like vegetable oil. We metabolize them like vegetable oil. There are a lot of 

other things in my life that I would worry about before I worried 

about a phthalate. 

Ms. SCHAKOWSKY. Yes. No, go ahead. Mr. Whitfield has one more 

comment as well. 

Mr. WHITFIELD. I am really perplexed by this hearing in the fact 

that the data seems so strong in so many ways. And, Mr. Lester, 

you and Dr. Schettler, you make the argument that there are alternative materials that can be used. They obviously are using them 

in Europe and whatever. These materials that are being used today 

have been used for 40 or 50 years. They have undergone all sorts 

of tests. Now can you categorically say with certainty that the substitute material that would be used instead of phthalates would not 

pose any harm to health in any way to young children or anyone 

else in our society? 

Dr. SCHETTLER. Well, just a couple of quick comments. As Ms. 

Stanley has said, the substitute depends on the application, so it 

is not just a drop in substitute. For example, there are alternatives 

to phthalates that used to be used in food wraps that are no longer 

used in food wraps, and now there are substitutes that have been 

well studied and considered to be far safer. 

Mr. WHITFIELD. Scientific studies. 

176 

Dr. SCHETTLER. Lots of scientific studies. 

Mr. WHITFIELD. And now they are being used in Europe today. 

Dr. SCHETTLER. But what I don’t know is because I am not a material scientist whether or not those same phthalates could be used 

in toys. In other words, you have two choices here. You can either 

use an alternative plasticizer or you can use an alternative material, and I think those rubber duckies there tell that story. One has 

phthalates because it is probably made out of vinyl that requires 

phthalates. The other is made out of an alternative material that 

doesn’t require a plasticizer, so there are different ways to approach the alternative question. 

Mr. WHITFIELD. If you know, I mean even in the European Union 

after they banned this, they came back and did another study and 

concluded that they were safe, but because of the politics of it, they 

didn’t want to go back. And I mean all of us are exposed to all sorts 

of things in our environment that may be harmful to us, and this 

item may be totally safe but other things may be harmful to us, 

and it seems to me that these particular substances that we are 

discussing specifically today are no more unsafe than a lot of other 

things that we are exposed to. And I think that we do have to look 

at the cost and the potential health that we have with substitutes. 

Dr. SCHETTLER. With respect, the characterization that the EU 

went back and re-examined it and determined they were safe is not 

my characterization, and I don’t think it is entirely accurate. It has 

been stated that way, but I don’t think it is entirely accurate. It 

has been stated that way though. 

Mr. WHITFIELD. I was reading an article here that says that. 

Dr. SCHETTLER. Yes, there are lots of descriptions about why the 

EU continued their ban, but as it was mentioned in the previous 

panel, they believed that there was significant enough risk associated with it despite the uncertainties, that they could and did, in 

fact, continue to keep phthalates out of toys without disrupting 

their toy market, and undoubtedly have reduced exposures in kids. 

Mr. WHITFIELD. Thank you. 

Ms. SCHAKOWSKY. I want to thank the panel, and I would like 

to ask for unanimous consent for inclusion of a statement by Chairman Dingell. Without objection, that will be included. That concludes our hearing, and I appreciate the testimony very much. 

[Whereupon, at 12:50 p.m., the subcommittee was adjourned.] 

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