[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]


 
   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



                  U.S. GOVERNMENT PRINTING OFFICE
56-091                    WASHINGTON : 2008
-----------------------------------------------------------------------
For sale by the Superintendent of Documents, U.S. Government Printing Office, 
http://bookstore.gpo.gov. For more information, contact the GPO Customer Contact Center, U.S. Government Printing Office. Phone 202ï¿½09512ï¿½091800, or 866ï¿½09512ï¿½091800 (toll-free). E-mail, [email protected].  


                    COMMITTEE ON ENERGY AND COMMERCE

                  JOHN D. DINGELL, Michigan, Chairman

HENRY A. WAXMAN, California          JOE BARTON, Texas
EDWARD J. MARKEY, Massachusetts          Ranking Member
RICK BOUCHER, Virginia               RALPH M. HALL, Texas
EDOLPHUS TOWNS, New York             J. DENNIS HASTERT, Illinois
FRANK PALLONE, Jr., New Jersey       FRED UPTON, Michigan
BART GORDON, Tennessee               CLIFF STEARNS, Florida
BOBBY L. RUSH, Illinois              NATHAN DEAL, Georgia
ANNA G. ESHOO, California            ED WHITFIELD, Kentucky
BART STUPAK, Michigan                BARBARA CUBIN, Wyoming
ELIOT L. ENGEL, New York             JOHN SHIMKUS, Illinois
GENE GREEN, Texas                    HEATHER WILSON, New Mexico
DIANA DeGETTE, Colorado              JOHN B. SHADEGG, Arizona
    Vice Chair                       CHARLES W. ``CHIP'' PICKERING, 
LOIS CAPPS, California               Mississippi
MIKE DOYLE, Pennsylvania             VITO FOSSELLA, New York
JANE HARMAN, California              ROY BLUNT, Missouri
TOM ALLEN, Maine                     STEVE BUYER, Indiana
JAN SCHAKOWSKY, Illinois             GEORGE RADANOVICH, California
HILDA L. SOLIS, California           JOSEPH R. PITTS, Pennsylvania
CHARLES A. GONZALEZ, Texas           MARY BONO MACK, California
JAY INSLEE, Washington               GREG WALDEN, Oregon
TAMMY BALDWIN, Wisconsin             LEE TERRY, Nebraska
MIKE ROSS, Arkansas                  MIKE FERGUSON, New Jersey
DARLENE HOOLEY, Oregon               MIKE ROGERS, Michigan
ANTHONY D. WEINER, New York          SUE WILKINS MYRICK, North Carolina
JIM MATHESON, Utah                   JOHN SULLIVAN, Oklahoma
G.K. BUTTERFIELD, North Carolina     TIM MURPHY, Pennsylvania
CHARLIE MELANCON, Louisiana          MICHAEL C. BURGESS, Texas
JOHN BARROW, Georgia                 MARSHA BLACKBURN, Tennessee
BARON P. HILL, Indiana

                                 ______

                           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)
        Subcommittee on Commerce, Trade, and Consumer Protection

                   BOBBY L. RUSH, Illinois, Chairman
JAN SCHAKOWSKY, Illinois             ED WHITFIELD, Kentucky
    Vice Chair                            Ranking Member
G.K. BUTTERFIELD, North Carolina     CLIFF STEARNS, Florida,
JOHN BARROW, Georgia                 CHARLES W. ``CHIP'' PICKERING, 
BARON P. HILL, Indiana                   Mississippi
EDWARD J. MARKEY, Massachusetts      VITO FOSSELLA, New York
RICK BOUCHER, Virginia               GEORGE RADANOVICH, California
EDOLPHUS TOWNS, New York             JOSEPH R. PITTS, Pennsylvania
DIANA DeGETTE, Colorado              MARY BONO MACK, California
CHARLES A. GONZALEZ, Texas           LEE TERRY, Nebraska
MIKE ROSS, Arkansas                  SUE WILKINS MYRICK, North Carolina
DARLENE HOOLEY, Oregon               JOHN SULLIVAN, Oklahoma
ANTHONY D. WEINER, New York          MICHAEL C. BURGESS, Texas
JIM MATHESON, Utah                   MARSHA BLACKBURN, Tennessee
CHARLIE MELANCON, Louisiana          JOE BARTON, Texas (ex officio)
JOHN D. DINGELL, Michigan (ex 
    officio)
  


                             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

                           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.


   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 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 Wal-Mart 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.
    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.
    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 clean-cut, 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 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 appreciate 
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 responsible 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 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.

   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.
    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:]

    [GRAPHIC] [TIFF OMITTED] T6091.001
    
    [GRAPHIC] [TIFF OMITTED] T6091.002
    
    [GRAPHIC] [TIFF OMITTED] T6091.003
    
    [GRAPHIC] [TIFF OMITTED] T6091.004
    
    [GRAPHIC] [TIFF OMITTED] T6091.005
    
    [GRAPHIC] [TIFF OMITTED] T6091.006
    
    [GRAPHIC] [TIFF OMITTED] T6091.007
    
    [GRAPHIC] [TIFF OMITTED] T6091.008
    
    [GRAPHIC] [TIFF OMITTED] T6091.009
    
    [GRAPHIC] [TIFF OMITTED] T6091.010
    
    [GRAPHIC] [TIFF OMITTED] T6091.011
    
    [GRAPHIC] [TIFF OMITTED] T6091.012
    
    [GRAPHIC] [TIFF OMITTED] T6091.013
    
    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 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, 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:]

    [GRAPHIC] [TIFF OMITTED] T6091.014
    
    [GRAPHIC] [TIFF OMITTED] T6091.015
    
    [GRAPHIC] [TIFF OMITTED] T6091.016
    
    [GRAPHIC] [TIFF OMITTED] T6091.017
    
    [GRAPHIC] [TIFF OMITTED] T6091.018
    
    [GRAPHIC] [TIFF OMITTED] T6091.019
    
    [GRAPHIC] [TIFF OMITTED] T6091.020
    
    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.
    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:]

    [GRAPHIC] [TIFF OMITTED] T6091.021
    
    [GRAPHIC] [TIFF OMITTED] T6091.023
    
    [GRAPHIC] [TIFF OMITTED] T6091.024
    
    [GRAPHIC] [TIFF OMITTED] T6091.025
    
    [GRAPHIC] [TIFF OMITTED] T6091.026
    
    [GRAPHIC] [TIFF OMITTED] T6091.027
    
    [GRAPHIC] [TIFF OMITTED] T6091.028
    
    [GRAPHIC] [TIFF OMITTED] T6091.029
    
    [GRAPHIC] [TIFF OMITTED] T6091.030
    
    [GRAPHIC] [TIFF OMITTED] T6091.031
    
    [GRAPHIC] [TIFF OMITTED] T6091.032
    
    [GRAPHIC] [TIFF OMITTED] T6091.033
    
    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 Toxicology 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:]

    [GRAPHIC] [TIFF OMITTED] T6091.034
    
    [GRAPHIC] [TIFF OMITTED] T6091.035
    
    [GRAPHIC] [TIFF OMITTED] T6091.036
    
    [GRAPHIC] [TIFF OMITTED] T6091.037
    
    [GRAPHIC] [TIFF OMITTED] T6091.038
    
    [GRAPHIC] [TIFF OMITTED] T6091.039
    
    [GRAPHIC] [TIFF OMITTED] T6091.040
    
    [GRAPHIC] [TIFF OMITTED] T6091.041
    
    [GRAPHIC] [TIFF OMITTED] T6091.042
    
    [GRAPHIC] [TIFF OMITTED] T6091.043
    
    [GRAPHIC] [TIFF OMITTED] T6091.044
    
    [GRAPHIC] [TIFF OMITTED] T6091.045
    
    [GRAPHIC] [TIFF OMITTED] T6091.046
    
    [GRAPHIC] [TIFF OMITTED] T6091.047
    
    [GRAPHIC] [TIFF OMITTED] T6091.048
    
    [GRAPHIC] [TIFF OMITTED] T6091.049
    
    [GRAPHIC] [TIFF OMITTED] T6091.050
    
    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 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?
    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.
    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.
    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, 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?
    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 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.
    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 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.
    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?
    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.
    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?
    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 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 co-author 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 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 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:]

    [GRAPHIC] [TIFF OMITTED] T6091.051
    
    [GRAPHIC] [TIFF OMITTED] T6091.052
    
    [GRAPHIC] [TIFF OMITTED] T6091.053
    
    [GRAPHIC] [TIFF OMITTED] T6091.054
    
    [GRAPHIC] [TIFF OMITTED] T6091.055
    
    [GRAPHIC] [TIFF OMITTED] T6091.056
    
    [GRAPHIC] [TIFF OMITTED] T6091.057
    
    [GRAPHIC] [TIFF OMITTED] T6091.058
    
    [GRAPHIC] [TIFF OMITTED] T6091.059
    
    [GRAPHIC] [TIFF OMITTED] T6091.060
    
    [GRAPHIC] [TIFF OMITTED] T6091.061
    
    [GRAPHIC] [TIFF OMITTED] T6091.062
    
    [GRAPHIC] [TIFF OMITTED] T6091.063
    
    [GRAPHIC] [TIFF OMITTED] T6091.064
    
    [GRAPHIC] [TIFF OMITTED] T6091.065
    
    [GRAPHIC] [TIFF OMITTED] T6091.066
    
    [GRAPHIC] [TIFF OMITTED] T6091.067
    
    [GRAPHIC] [TIFF OMITTED] T6091.068
    
    [GRAPHIC] [TIFF OMITTED] T6091.069
    
    [GRAPHIC] [TIFF OMITTED] T6091.070
    
    [GRAPHIC] [TIFF OMITTED] T6091.071
    
    [GRAPHIC] [TIFF OMITTED] T6091.072
    
    [GRAPHIC] [TIFF OMITTED] T6091.073
    
    [GRAPHIC] [TIFF OMITTED] T6091.074
    
    [GRAPHIC] [TIFF OMITTED] T6091.075
    
    [GRAPHIC] [TIFF OMITTED] T6091.076
    
    [GRAPHIC] [TIFF OMITTED] T6091.077
    
    [GRAPHIC] [TIFF OMITTED] T6091.078
    
    [GRAPHIC] [TIFF OMITTED] T6091.079
    
    [GRAPHIC] [TIFF OMITTED] T6091.080
    
    [GRAPHIC] [TIFF OMITTED] T6091.081
    
    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.
    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 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:]

    [GRAPHIC] [TIFF OMITTED] T6091.082
    
    [GRAPHIC] [TIFF OMITTED] T6091.083
    
    [GRAPHIC] [TIFF OMITTED] T6091.084
    
    [GRAPHIC] [TIFF OMITTED] T6091.085
    
    [GRAPHIC] [TIFF OMITTED] T6091.086
    
    [GRAPHIC] [TIFF OMITTED] T6091.087
    
    [GRAPHIC] [TIFF OMITTED] T6091.088
    
    [GRAPHIC] [TIFF OMITTED] T6091.089
    
    [GRAPHIC] [TIFF OMITTED] T6091.090
    
    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 bisphenol-A, 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 
bisphenol-A 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 of exposure. For example, the World 
Health Organization has already 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:]

    [GRAPHIC] [TIFF OMITTED] T6091.091
    
    [GRAPHIC] [TIFF OMITTED] T6091.092
    
    [GRAPHIC] [TIFF OMITTED] T6091.093
    
    [GRAPHIC] [TIFF OMITTED] T6091.094
    
    [GRAPHIC] [TIFF OMITTED] T6091.095
    
    [GRAPHIC] [TIFF OMITTED] T6091.096
    
    [GRAPHIC] [TIFF OMITTED] T6091.097
    
    [GRAPHIC] [TIFF OMITTED] T6091.098
    
    [GRAPHIC] [TIFF OMITTED] T6091.099
    
    [GRAPHIC] [TIFF OMITTED] T6091.100
    
    [GRAPHIC] [TIFF OMITTED] T6091.101
    
    [GRAPHIC] [TIFF OMITTED] T6091.102
    
    [GRAPHIC] [TIFF OMITTED] T6091.103
    
    [GRAPHIC] [TIFF OMITTED] T6091.104
    
    [GRAPHIC] [TIFF OMITTED] T6091.105
    
    [GRAPHIC] [TIFF OMITTED] T6091.106
    
    [GRAPHIC] [TIFF OMITTED] T6091.107
    
    [GRAPHIC] [TIFF OMITTED] T6091.108
    
    [GRAPHIC] [TIFF OMITTED] T6091.109
    
    [GRAPHIC] [TIFF OMITTED] T6091.110
    
    [GRAPHIC] [TIFF OMITTED] T6091.111
    
    [GRAPHIC] [TIFF OMITTED] T6091.112
    
    [GRAPHIC] [TIFF OMITTED] T6091.113
    
    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 cost-effective 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. 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:]

    [GRAPHIC] [TIFF OMITTED] T6091.114
    
    [GRAPHIC] [TIFF OMITTED] T6091.115
    
    [GRAPHIC] [TIFF OMITTED] T6091.116
    
    [GRAPHIC] [TIFF OMITTED] T6091.117
    
    [GRAPHIC] [TIFF OMITTED] T6091.118
    
    [GRAPHIC] [TIFF OMITTED] T6091.119
    
    [GRAPHIC] [TIFF OMITTED] T6091.120
    
    [GRAPHIC] [TIFF OMITTED] T6091.121
    
    [GRAPHIC] [TIFF OMITTED] T6091.122
    
    [GRAPHIC] [TIFF OMITTED] T6091.123
    
    [GRAPHIC] [TIFF OMITTED] T6091.124
    
    [GRAPHIC] [TIFF OMITTED] T6091.125
    
    [GRAPHIC] [TIFF OMITTED] T6091.126
    
    [GRAPHIC] [TIFF OMITTED] T6091.127
    
    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 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.
    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 number, the margin of exposure 
for North Carolina children ages 1\1/2\ 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 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 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 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?
    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.
    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.]
    [Material submitted for inclusion in the record follows:]

    [GRAPHIC] [TIFF OMITTED] T6091.128
    
    [GRAPHIC] [TIFF OMITTED] T6091.129
    
    [GRAPHIC] [TIFF OMITTED] T6091.130
    
    [GRAPHIC] [TIFF OMITTED] T6091.131
    
    [GRAPHIC] [TIFF OMITTED] T6091.132
    
    [GRAPHIC] [TIFF OMITTED] T6091.133
    
    [GRAPHIC] [TIFF OMITTED] T6091.134
    
    [GRAPHIC] [TIFF OMITTED] T6091.135
    
    [GRAPHIC] [TIFF OMITTED] T6091.136
    
    [GRAPHIC] [TIFF OMITTED] T6091.137
    
    [GRAPHIC] [TIFF OMITTED] T6091.138
    
    [GRAPHIC] [TIFF OMITTED] T6091.139
    
    [GRAPHIC] [TIFF OMITTED] T6091.140
    
    [GRAPHIC] [TIFF OMITTED] T6091.141
    
    [GRAPHIC] [TIFF OMITTED] T6091.142
    
    [GRAPHIC] [TIFF OMITTED] T6091.143
    
    [GRAPHIC] [TIFF OMITTED] T6091.144
    
    [GRAPHIC] [TIFF OMITTED] T6091.145
    
    [GRAPHIC] [TIFF OMITTED] T6091.146
    
    [GRAPHIC] [TIFF OMITTED] T6091.147
    
    [GRAPHIC] [TIFF OMITTED] T6091.148
    
    [GRAPHIC] [TIFF OMITTED] T6091.149
    
    [GRAPHIC] [TIFF OMITTED] T6091.150
    
    [GRAPHIC] [TIFF OMITTED] T6091.151
    
    [GRAPHIC] [TIFF OMITTED] T6091.152
    
    [GRAPHIC] [TIFF OMITTED] T6091.153
    
    [GRAPHIC] [TIFF OMITTED] T6091.154
    
    [GRAPHIC] [TIFF OMITTED] T6091.155
    
    [GRAPHIC] [TIFF OMITTED] T6091.156
    
    [GRAPHIC] [TIFF OMITTED] T6091.157
    
    [GRAPHIC] [TIFF OMITTED] T6091.158
    
    [GRAPHIC] [TIFF OMITTED] T6091.159
    
    [GRAPHIC] [TIFF OMITTED] T6091.160
    
    [GRAPHIC] [TIFF OMITTED] T6091.161
    
    [GRAPHIC] [TIFF OMITTED] T6091.162
    
    [GRAPHIC] [TIFF OMITTED] T6091.163
    
    [GRAPHIC] [TIFF OMITTED] T6091.164
    
    [GRAPHIC] [TIFF OMITTED] T6091.165
    
    [GRAPHIC] [TIFF OMITTED] T6091.166
    
    [GRAPHIC] [TIFF OMITTED] T6091.167
    
    [GRAPHIC] [TIFF OMITTED] T6091.168
    
    [GRAPHIC] [TIFF OMITTED] T6091.169
    
    [GRAPHIC] [TIFF OMITTED] T6091.170
    
    [GRAPHIC] [TIFF OMITTED] T6091.171
    
    [GRAPHIC] [TIFF OMITTED] T6091.172
    
    [GRAPHIC] [TIFF OMITTED] T6091.173
    

                                 
