[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
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56-091 WASHINGTON : 2008
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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
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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:]
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Ms. Schakowsky. Thank you. Dr. Bucher.
STATEMENT OF JOHN R. BUCHER, PH.D., ASSOCIATE DIRECTOR,
NATIONAL TOXICOLOGY PROGRAM, NATIONAL INSTITUTE OF
ENVIRONMENTAL HEALTH SCIENCES, NATIONAL INSTITUTES OF HEALTH
Dr. Bucher. Thank you, Madam Chairman, and good morning. I
am John Bucher, Associate Director of the National Toxicology
Program. The NTP is an interagency program, funded and managed
by the National Institute of Environmental Health Sciences.
NIEHS and NTP are part of the National Institutes of Health.
The NTP carries out toxicology research and testing on
substances of concern to the Federal Government and the public.
We also perform literature review and analysis activities and
since 1980 have produced the Report on Carcinogens. In 1998, we
established the Center for the Evaluation of Risks to Human
Reproduction, CERHR, which carries out literature evaluations
on substances that may affect human reproduction and
development.
The NTP has extensively researched phthalates for cancer
and reproductive effects in animals, and through the CERHR, has
reviewed the world's literature on seven phthalates for
potential effects on human reproductive health. We have studied
bisphenol-A, BPA, less extensively in animals, although
recently we conducted a lengthy evaluation of the very large
literature on the potential for BPA to affect reproduction and
development. This evaluation culminates tomorrow with a public
peer review of the Draft NTP Brief on Bisphenol-A before our
NTP Board of Scientific Counselors. This draft brief represents
our opinion of the science on BPA and is based on our
evaluation to date of the literature, informed by the findings
of an expert panel and with consideration of public comments
solicited on five separate occasions.
BPA is a high-production industrial chemical used to
manufacture polycarbonate plastics and epoxy linings of tin
cans. It has been known since 1938 to mimic estrogen when given
in large amounts to experimental animals. More recently, it has
also been studied for its ability at very much lower doses to
affect hormonal processes involved in development, when an
animal is exposed as a fetus or during infancy. BPA leaches in
small amounts from plastic items such as polycarbonate baby
bottles and can be measured in infant formula coming from
epoxy-lined cans. The 2003 NHANES survey conducted by the CDC
found detectable levels of bisphenol-A in 93 percent of over
2,500 hundred urine samples from people 6 years of age and
older. These data are considered representative of exposures in
the United States.
The best estimates that we have suggest that the doses of
BPA causing subtle effects on the development of animals are
close to estimates of current exposures to the general U.S.
population. Taking this information into account, the NTP
reached several preliminary conclusions in our draft brief. We
expressed some concern that current estimated exposures of BPA
to fetuses, infants, and children could cause neural and
behavioral effects, effects on the prostate and mammary gland,
and an earlier age at which females attain puberty. We express
negligible concern or minimal concern that current exposures to
BPA could cause adverse health effects 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:]
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Ms. Schakowsky. Dr. Alderson.
STATEMENT OF NORRIS ALDERSON, PH.D., ASSOCIATE COMMISSIONER FOR
SCIENCE, FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN SERVICES, ROCKVILLE, MARYLAND
Dr. Alderson. Good morning, Madam Chair, and members of the
subcommittee. I am Norris Alderson, Associate Commissioner for
Science at the FDA. Thank you for providing an opportunity to
discuss FDA's ongoing work regarding the safety of bisphenol-A.
This past April, FDA Commissioner Dr. von Eschenbach, formed an
agency-wide BPA task force, which I chair, to conduct a review
of the concerns raised in a recent review of the literature on
the safety of BPA. The task force is undertaking a cross agency
look at the current research and information on the safety of
BPA. Although our review is ongoing, at this time we have no
reason to recommend that consumers stop using products
containing BPA.
A large body of evidence indicates that currently marketed
products containing BPA such as baby bottles and food
containers are safe, and that exposure levels to BPA from these
products are well below those that may cause health effects. I
also want to emphasize that research on the safety of BPA is a
very active area. If FDA's review leads us to a determination
that the use of BPA is not safe, we will not hesitate to take
action to protect the public health. I also want to note that
at FDA's request a subcommittee of the FDA science board will
review our task force report on the safety of BPA and will hold
a public meeting on the topic later this year. The science
board, which is an independent advisory body to FDA, will
receive the findings of the subcommittee during its fall
meeting.
Bisphenol-A is used in the manufacture of two types of
polymers used in food contact articles. Polycarbonate plastics
are used in products such as water and infant bottles, while
epoxy-based enamels and coatings are widely used as inner
linings for food and beverage cans. These food contact
substances have been regulated by FDA for many years. Small
residual amounts of trace BPA can remain in polymers and may
migrate to food during the use of the product. For this reason,
FDA's safety assessments include a consideration of likely
consumer exposure. We have determined that dietary exposure to
BPA from these uses is in the very low parts per billion range.
The task force is looking at all products we regulate to get a
better understanding of the total exposure.
We are already focusing on the specific concerns raised by
the reports that Dr. Bucher just talked about. In November of
2007, the NTP Center for Evaluation of Risks to Human
Reproduction released its expert panel report which stated that
there are minimal concerns for BPA exposure to pregnant women,
fetuses, infants, and children. The NTP draft report later in
April of this year reiterated that panel's conclusions but
upgraded some of those concerns. These analyses included
relatively new data and emerging or difficult to interpret
endpoints in toxicology, and considered the fact that the
studies currently available provide limited evidence and
contain numerous uncertainties.
FDA has carefully studied the report and conclusions of the
NTP's expert panel, and we are actively reviewing the NTP task
force report. Also, FDA's National Center for Toxicological
Research in Jefferson, Arkansas is discussing with the NTP
additional research needs relating to BPA. Neural and behavior
development effects were also the focus of a recent draft risk
assessment released by Health Canada and Environment Canada in
April. FDA has been discussing this report with our Canadian
counterparts. The NTP draft brief and the Canadian draft risk
assessment both suggest that more research is needed. FDA
itself began a formal risk reassessment of BPA in early 2007.
FDA's initial reevaluation of BPA safety focused on possible
low dose effects, and we concluded that the current level of
exposure to adults and infants is safe.
This conclusion was based on a review of the most relevant
data, including our reviews completed in July, 2007, on two
pivotal multi-generational studies. FDA's findings thus far are
supported by the conclusions of two risk assessments conducted
by the European Food Safety Authority and the Japanese National
Institute of Advanced Industrial Science and Technology. Let me
briefly mention phthalates, which are also a concern to this
subcommittee. The BPA task force is also compiling a
comprehensive inventory of FDA products that contain
phthalates. FDA, primarily through NCTR, is conducting research
to broaden our understanding of potential health risks posed by
exposure to phthalates.
In conclusion, let me emphasize that current evidence
indicates that BPA exposure from food contact materials is well
below the levels that may cause health effects, but FDA's
conclusions on the safety of the products it regulates are
never set in stone. They are always subject to review or
revision when new data or better analyses become available. At
the end of the day, FDA's goal is always to act within our
authority to protect the public health. Thank you for the
opportunity to testify today. I will be happy to answer any of
your questions.
[The prepared statement of Dr. Alderson follows:]
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Ms. Schakowsky. Dr. Gray.
STATEMENT OF L. EARL GRAY, JR., SENIOR REPRODUCTIVE BIOLOGIST
AND TOXICOLOGIST, REPRODUCTIVE TOXICOLOGY DIVISION, OFFICE OF
RESEARCH AND DEVELOPMENT, ENVIRONMENTAL PROTECTION AGENCY
Dr. Gray. Good morning, Ms. Chairman, and members of the
committee. My name is Earl Gray, and I am a senior reproductive
biologist and toxicologist in the Reproductive Toxicology
Division in the Office of Research and Development of EPA. The
views expressed here in my testimony today represent my
personal views as a scientist and do not necessarily reflect
the position of the EPA or the Administration. My research at
EPA has focused on the effects of chemicals including endocrine
disrupters on the cellular and molecular modes of toxicity
leading to abnormal reproductive development in rodents, and we
have studied a variety of chemicals including phthalates and
bisphenol-A.
In these studies, rat mothers are exposed to an individual
chemical or a mixture of chemicals during pregnancy, and the
offspring are examined after birth to determine if the chemical
induced adverse effects. Phthalates are a high production
volume chemical used in many consumer products including toys,
baby products, pharmaceuticals, cosmetics, personal care
products, and medical devices. The phthalates are ubiquitous in
our daily environment and most people, including pregnant women
and their fetuses, are exposed to multiple phthalates. In rats,
some phthalates cause liver cancer, spontaneous abortions, and
reproductive tract malformations in male and female rat
offspring. The abnormalities seen in the male rat offspring are
described as phthalate syndrome. This syndrome is the focus of
many regulatory agencies since it occurs at lower dosage levels
than other adverse effects.
The phthalate syndrome is manifested by undescended testes,
malformations of the penis and internal reproductive tract and
shortened ano-genital distance in males. The process that is
disrupted is known as sexual differentiation. It is a process
common to all mammals including humans. During sexual
differentiation, phthalates disrupt testis function reducing
fetal androgen levels which in turn causes abnormal male
reproductive tract development, and in fact there are a variety
of human syndromes associated with disruption of this pathway.
Recently concerns have been expressed about the effects of
mixtures of phthalates since humans are exposed to multiple
phthalates at one time. Studies with rats show that combining
phthalates with other phthalates or with pesticides cause
cumulative adverse effects. They do not act independently.
A key question is how do the levels of phthalates that
affect rats compare with human exposures? In the last few years
several studies have shown that although phthalate levels in
most humans are low, a small percentage of people are exposed
to much higher levels of phthalates, and when one compares the
level of phthalate metabolites in human versus rat amniotic
fluid, the environment that the fetus develops in, the levels
in humans aren't always that different from those in affected
rats, thus the margin of exposure is not always as large as one
would like. Using the National 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:]
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Ms. Schakowsky. I want to thank the witnesses for their
testimony, and we will begin the questioning now. I will begin
with that questioning for 5 minutes. I wanted to ask Dr.
Babich, there seems at least to me to be some confusion in the
media and even in some testimony, are there phthalates in
teethers, rattles, and pacifiers, and, if so, which phthalate?
Dr. Babich. In 2002 there were no phthalates in teethers,
rattles, or pacifiers.
Ms. Schakowsky. Do you know that because CPSC actually
tested it?
Dr. Babich. In 2002, we tested teethers, rattles, soft
plastic toys, the kinds of products that children mouth, and
there were no phthalates in teethers, rattles, and of course
pacifiers, and about 40 percent of the soft plastic toys
contained DINP. There were for the most part very few that had
phthalates. Some had phthalate substitutes.
Ms. Schakowsky. So there was a voluntary agreement in which
the industry agreed to exclude DEHP and DINP from toys also.
What percentage did you say was still present in toys?
Dr. Babich. Well, in 2002 the soft plastic toys, which were
not part of the agreement, 40 percent of them had DINP.
Ms. Schakowsky. They were not part of the----
Dr. Babich. Not part of the agreement applied to teethers,
rattles, and pacifiers.
Ms. Schakowsky. Do foreign manufacturers comply with these
voluntary agreements?
Dr. Babich. In 2002, we surveyed pretty much everything we
could get our hands on, and that is what we found.
Ms. Schakowsky. And so there is no ongoing----
Dr. Babich. So, yes, I would say that as far as we know
they do comply.
Ms. Schakowsky. OK. And there is no ongoing testing or----
Dr. Babich. Not at the moment, no.
Ms. Schakowsky. But unlike the FDA, the CPSC doesn't have
pre-market approval of chemicals, is that correct?
Dr. Babich. True.
Ms. Schakowsky. That is true. Dr. Bucher, in your testimony
you referred to active phthalates. I wondered if you could
expand on that, which phthalates are considered active and why,
what makes them active?
Dr. Bucher. Well, there are certain phthalates based on
their structure that when metabolized break down to common
toxic intermediates, and both Dr. Gray and Dr. Foster, who is
accompanying me, are world experts on phthalates and probably
would be better to address this issue, but when I mentioned
active phthalates it is those that are toxic as opposed to
those classes of phthalates that are in fact not toxic.
Ms. Schakowsky. Did you want to comment on that then, Dr.
Gray?
Dr. Gray. Yes. I agree with Dr. Bucher's comments. Some
phthalates have no activity in inhibiting fetal rat
testosterone synthesis and others are active in this assay. It
is determined by the structure activity, and the interesting
structure activity for the fetal effects is similar to that
seen for the testicular effects in the 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:]
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Ms. Schakowsky. Thank you. Dr. Schettler.
STATEMENT OF TED SCHETTLER, M.D., M.P.H., SCIENCE DIRECTOR,
SCIENCE AND ENVIRONMENTAL HEALTH NETWORK, ANN ARBOR, MICHIGAN
Dr. Schettler. Thank you, Madam Chair, members of the
committee. Thank you for the opportunity to comment today on
the safety of phthalates and bisphenol-A. My name is Ted
Schettler. I am a physician. I have both a medical degree and a
Master's in public health with training in toxicology and
epidemiology, as well as the traditional medical sciences. I
participated in an investigation of phthalate exposures in
infants in two hospitals. I have published papers and
monographs addressing phthalate exposures and toxicity. I am
currently the Science Director of the Science and Environmental
Health Network. I have provided you with some written comments,
and I will briefly summarize those now.
The chemicals that we are discussing today are in the
bodies of virtually every American. They are in fetuses,
infants, and children. Health impacts linked to these chemicals
are determined from animal testing and to a limited extent in
humans, are among those that are prominent in people today, so
today's topics are of obvious public health concern. First I
will comment on phthalates. People in the general public are
regularly exposed to mixtures of phthalates because of their
widespread use in consumer products and general environmental
contamination. Some individuals are exposed at much higher
levels than others. Phthalates cross the placenta and the
developing fetus is also exposed. Members of the phthalate
family of chemicals have both similarities and differences in
their chemical structures. Some phthalates have enough in
common to cause similar toxic effects.
This means that when we estimate risks, we need to consider
phthalate exposures in the aggregate, not simply risks
associated with single chemicals from single sources. The
developing male reproductive tract is particularly vulnerable
to phthalates. Exposures in laboratory animals, as we have
heard, cause a variety of malformations, including hypospadias,
which is a birth defect of the penis with increasing incidence
in baby boys in birth defect registries in the United States,
undescended testes, and reduced sperm counts. At least six
different phthalates interfere with normal testosterone
production. That helps to explain how they alter reproductive
tract development. When they are studied in mixtures, their
doses are additive.
This is a critical issue for public health protection.
People are not exposed to single phthalates, but rather to
mixtures. We need to think about that when drawing conclusions
about risk. Some people are exposed to single phthalates at
particularly high levels. In our study in two Boston hospitals,
for example, we determined that some infants were exposed to
DEHP from medical devices at levels in excess of FDA's
tolerable intake. When exposures are considered in the
aggregate, as they should be for a subset of these chemicals,
the number of people with excessive exposure is much larger.
Studies of phthalates in humans are limited although evidence
consistent with impacts at current exposure levels is beginning
to accumulate.
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:]
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Ms. Schakowsky. Dr. Willhite.
STATEMENT OF CALVIN WILLHITE, PH.D., STATE OF CALIFORNIA,
DEPARTMENT OF TOXIC SUBSTANCES CONTROL, BERKELEY, CALIFORNIA
Mr. Willhite. Good morning, Madam Chairman and committee
members.
My name is Calvin Willhite, and I am a toxicologist with
the State of California. However, none of my written or verbal
testimony should be interpreted as representing that of the
State of California. I am here today on behalf of NSF
International, which used to be called the National Sanitation
Foundation, and their health advisory board. Today I am going
to speak about 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:]
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Ms. Schakowsky. Mr. Lester.
STATEMENT OF STEPHEN LESTER, SCIENCE DIRECTOR, CENTER FOR
HEALTH, ENVIRONMENT AND JUSTICE, FALLS CHURCH, VIRGINIA
Mr. Lester. Madam Chair, distinguished members of the
subcommittee, thank you for this opportunity to testify on the
safety of phthalates and bisphenol-A in everyday consumer
products. My name is Stephen Lester, and I am the Science
Director with the Center for Health, Environment and Justice.
CHEJ is a national environmental health organization founded in
1981 by Love Canal community leader Lois Gibbs. We assist
people to fight for justice, empower them to protect their
communities, and lead national environmental health campaigns.
Phthalates are used to make PVC plastic toys and other PVC
products soft and flexible. When children play with or chew on
vinyl toys, phthalates can leach out of these products.
As we have heard, phthalates have been linked to
reproductive problems during development in both girls and
boys. Safe or 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:]
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Ms. Schakowsky. Thank you. We will begin our questioning
now, and I will begin with myself for 5 minutes. Ms. Stanley,
you state that it is a myth that phthalates are used for
teething rings, and yet Mr. Lester, in your written testimony I
was listening for, I am not sure you said it, states that
phthalates are used in teething rings, so now that we have both
of you here, I am wondering if you could first state how you
know that, what is used instead of phthalates.
Ms. Stanley. Certainly, I can answer that question. There
have been a couple of voluntary agreements that the toy
industry has had with removing some phthalates. The first was
in the early 1980s, and that was DEHP. There was the threat of
rodent liver cancer. There was a voluntary agreement, now part
of an ASTM standard, that limited that phthalate to 3 percent
in teethers, rattles, and pacifiers.
Ms. Schakowsky. Is that only for U.S. manufacturers?
Ms. Stanley. Yes. That is for U.S. manufacturers.
Ms. Schakowsky. So it could be imported. It could be in
teething rings that are imported?
Ms. Stanley. I wouldn't imagine that because I know that
the toy industry association from my discussions with them has
very strict standards, and they enforce those standards with
their manufacturers overseas, particularly in Asia. Now the
second part of a restriction was with DINP, and as Dr. Babich
from CPSC discussed, that was in the late '90s. Now I don't
know what has been substituted, but once the market shifts
away, that shift will pretty much remain permanent. I have not
had discussions with the toy industry association. I know they
support the continued use of DINP because of all the reviews
and their certainty that it is safe to use with children.
Ms. Schakowsky. OK. Mr. Lester.
Mr. Lester. Well, I can't speak to this specifically, but
it is my understanding that because so many of the toys are
imported now that there is no control or oversight over which
of these contain or not contain phthalates.
Ms. Schakowsky. OK. You do speak to it specifically in your
testimony saying that among other things phthalates are used in
soft PVC toys and other baby products such as teething rings,
rubber duckies, and bath books.
Mr. Lester. Well, what I am referring to there is that
these are products that are imported into the United States. It
is my understanding that, yes, phthalates are included in these
products.
Ms. Schakowsky. OK. Let me ask another question. In former
testimony, I think it was Dr. Babich saying that when testing
how children actually mouth various things, it said that it was
lower than expected, and that the greatest amount was on their
fingers, and I am just wondering if there is the possibility of
harm done because of sucking on their fingers and if anybody
here has any data on that, whether it is transferable. Dr.
Schettler.
Dr. Schettler. I published a paper on human exposure to
phthalates from consumer products, and in the process of doing
the research for that paper tried to wrap my head around
figuring out where the phthalates come from, if anybody really
knows. And as Dr. Gray mentioned in the previous panel,
sometimes people are 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:]
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