[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]
ENDOCRINE-DISRUPTING CHEMICALS IN DRINKING WATER: RISKS TO HUMAN HEALTH
AND THE ENVIRONMENT
=======================================================================
HEARING
BEFORE THE
SUBCOMMITTEE ON ENERGY AND ENVIRONMENT
OF THE
COMMITTEE ON ENERGY AND COMMERCE
HOUSE OF REPRESENTATIVES
ONE HUNDRED ELEVENTH CONGRESS
SECOND SESSION
__________
FEBRUARY 25, 2010
__________
Serial No. 111-99
Printed for the use of the Committee on Energy and Commerce
energycommerce.house.gov
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COMMITTEE ON ENERGY AND COMMERCE
HENRY A. WAXMAN, California, Chairman
JOHN D. DINGELL, Michigan JOE BARTON, Texas
Chairman Emeritus Ranking Member
EDWARD J. MARKEY, Massachusetts RALPH M. HALL, Texas
RICK BOUCHER, Virginia FRED UPTON, Michigan
FRANK PALLONE, Jr., New Jersey CLIFF STEARNS, Florida
BART GORDON, Tennessee NATHAN DEAL, Georgia
BOBBY L. RUSH, Illinois ED WHITFIELD, Kentucky
ANNA G. ESHOO, California JOHN SHIMKUS, Illinois
BART STUPAK, Michigan JOHN B. SHADEGG, Arizona
ELIOT L. ENGEL, New York ROY BLUNT, Missouri
GENE GREEN, Texas STEVE BUYER, Indiana
DIANA DeGETTE, Colorado GEORGE RADANOVICH, California
Vice Chairman JOSEPH R. PITTS, Pennsylvania
LOIS CAPPS, California MARY BONO MACK, California
MICHAEL F. DOYLE, Pennsylvania GREG WALDEN, Oregon
JANE HARMAN, California LEE TERRY, Nebraska
TOM ALLEN, Maine MIKE ROGERS, Michigan
JANICE D. SCHAKOWSKY, Illinois SUE WILKINS MYRICK, North Carolina
CHARLES A. GONZALEZ, Texas JOHN SULLIVAN, Oklahoma
JAY INSLEE, Washington TIM MURPHY, Pennsylvania
TAMMY BALDWIN, Wisconsin MICHAEL C. BURGESS, Texas
MIKE ROSS, Arkansas MARSHA BLACKBURN, Tennessee
ANTHONY D. WEINER, New York PHIL GINGREY, Georgia
JIM MATHESON, Utah STEVE SCALISE, Louisiana
G.K. BUTTERFIELD, North Carolina
CHARLIE MELANCON, Louisiana
JOHN BARROW, Georgia
BARON P. HILL, Indiana
DORIS O. MATSUI, California
DONNA CHRISTENSEN, Virgin Islands
KATHY CASTOR, Florida
JOHN P. SARBANES, Maryland
CHRISTOPHER S. MURPHY, Connecticut
ZACHARY T. SPACE, Ohio
JERRY McNERNEY, California
BETTY SUTTON, Ohio
BRUCE BRALEY, Iowa
PETER WELCH, Vermont
(ii)
Subcommittee on Energy and Environment
EDWARD J. MARKEY, Massachusetts, Chairman
MICHAEL F. DOYLE, Pennsylvania RALPH M. HALL, Texas
JAY INSLEE, Washington FRED UPTON, Michigan
G.K. BUTTERFIELD, North Carolina ED WHITFIELD, Kentucky
CHARLIE MELANCON, Louisiana JOHN SHIMKUS, Illinois
BARON HILL, Indiana JOHN B. SHADEGG, Arizona
DORIS O. MATSUI, California STEVE BUYER, Indiana
JERRY McNERNEY, California GREG WALDEN, Oregon
PETER WELCH, Vermont SUE WILKINS MYRICK, North Carolina
JOHN D. DINGELL, Michigan JOHN SULLIVAN, Oklahoma
RICK BOUCHER, Virginia MICHAEL C. BURGESS, Texas
FRANK PALLONE, Jr., New Jersey
ELIOT ENGEL, New York
GENE GREEN, Texas
LOIS CAPPS, California
JANE HARMAN, California
CHARLES A. GONZALEZ, Texas
TAMMY BALDWIN, Wisconsin
MIKE ROSS, Arkansas
JIM MATHESON, Utah
JOHN BARROW, Georgia
C O N T E N T S
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Page
Hon. Edward J. Markey, a Representative in Congress from the
Commonwealth of Massachussetts, opening statement..............
Hon. Cliff Stearns, a Representative in Congress from the State
of Florida, opening statement..................................
Hon. John Shimkus, a Representative in Congress from the State of
Illinois, opening statement....................................
Hon. Lois Capps, a Representative in Congress from the State of
California, opening statement..................................
Hon. Gene Green, a Representative in Congress from the State of
Texas, prepared statement......................................
Hon. Joe Barton, a Representative in Congress from the State of
Texas, prepared statement......................................
Hon. Michael C. Burgess, a Representative in Congress from the
State of Texas, prepared statement.............................
Witnesses
Hon. James P. Moran, a Representative in Congress from the
Commonwealth of Virginia.......................................
Prepared statement...........................................
Linda Birnbaum, Director, National Institute for Environmental
Health Sciences................................................
Prepared statement...........................................
Answers to submitted questions...............................
James Jones, Deputy Assistant Administrator, Office of
Prevention, Pesticides and Toxic Substances, Environmental
Protection Agency..............................................
Prepared statement...........................................
Answers to submitted questions...............................
Gina Solomon, Senior Scientist, National Resources Defense
Council........................................................
Prepared statement...........................................
Answers to submitted questions...............................
Christopher J. Borgert, President and Principal Scientist,
Applied Pharmacology and Toxicology, Inc.......................
Prepared statement...........................................
Answers to submitted questions...............................
Submitted material
Statement of American Water Works Association....................
Statement of American Chemistry Council..........................
Statement of Hon. Louise M. Slaughter............................
ENDOCRINE-DISRUPTING CHEMICALS IN DRINKING WATER: RISKS TO HUMAN HEALTH
AND THE ENVIRONMENT
THURSDAY, FEBRUARY 25, 2010
House of Representatives,
Subcommittee on Energy and Environment,
Committee on Energy and Commerce,
Washington, DC.
The Subcommittee met, pursuant to call, at 9:34 a.m., in
Room 2123 of the Rayburn House Office Building, Hon. Edward J.
Markey [Chairman of the Subcommittee] presiding.
Members present: Representatives Markey, Inslee, McNerney,
Green, Capps, Matheson, Barrow, Moran, Stearns, Shimkus,
Burgess, and Scalise.
Staff present: Jackie Cohen, Counsel; Tracy Sheppard,
Counsel; Melissa Cheatham, Professional staff; Michael
Freedhoff, Professional staff; Peter Ketcham-Colwill, Special
Assistant; Caitlin Haberman, Special Assistant; Earley Green,
Chief Clerk; Jerry Couri, Minority Professional Staff; and
Garrett Golding, Minority Legislation Analyst.
OPENING STATEMENT OF HON. EDWARD J. MARKEY, A REPRESENTATIVE IN
CONGRESS FROM THE COMMONWEALTH OF MASSACHUSETTS
Mr. Markey. Welcome, ladies and gentlemen. Lately not a day
goes by where the public is not reminded of the presence of
toxic chemicals in the air we breathe and in the water we
drink, and the potential harmful effect that these chemicals
can have on public health and the environment. Just last week,
a local newspaper warned that the Potomac River and other Mid-
Atlantic rivers are awaste with toxins that may be responsible
for bizarre deformities in fish, frogs, and other wildlife that
come in contact with the contaminated water. This includes male
fish that have begun growing female sexual organs and female
fish that can no longer reproduce.
W.C. Fields once said I never drink water because of the
disgusting things that fish do in it. Well, today people wonder
whether they should be drinking the water that comes out of
their taps because of the disgusting things it is doing to the
fish and possibly to them. There are serious concerns that the
same chemicals that are responsible for these deformities in
wildlife may also have similar effects in humans. They may be
the culprit for the widespread increase in human disorders such
as infertility, obesity, diabetes, and cardiovascular disease.
These contaminants which fall under a class of chemicals called
endocrine disruptors are pervasively showing up in our Nation's
waterways including in water that millions of people rely on
for drinking.
For example, Dispenol-A BPA, which is used in many plastic
containers and as a lining in canned food is associated with
developmental and reproductive disorders in humans. To this
end, the FDA recently announced that it is concerned about
these health effects and I have got a bill to ban its use in
food and beverage containers in hope that we can finally stop
limiting our exposure.
Tyclasin is another example of an endocrine disruptor which
is used as an anti-microbial in hand soaps. Tyclasin has been
shown to interfere with the development of the brain and
nervous systems of laboratory animals, and I am concerned about
the consequences on human health. I have asked both FDA and EPA
what they plan on doing about evaluating and regulating
Tyclasin's widespread use.
Perchlorate used as an ingredient in rocket fuel is
pervasively showing up in drinking water all across the Nation.
We are looking for that extra boost in the morning, but I would
personally rather stick to a large cup of coffee.
Massachusetts is one of the few states that regularly
monitors perchlorate and has also set a statewide water
standard for the contaminant. Exposure to this chemical during
pregnancy can cause serious neurological deficits and could be
one of the contributing causes of increased attention deficit
disorders and other cognitive problems in our Nation's
children.
All of these dangerous chemicals along with others whose
health effects are less well known have been found by
government scientists to be contained in our Nation's surface
water, ground water, and drinking water. In 1996, The Food
Quality Protection Act and Safe Drinking Water Act amendments
authorized EPA to screen for endocrine disruptors in sources of
drinking water.
In response to that statute, the EPA established the
endocrine disruptor screening program designed to evaluate the
safety of chemicals that might cause adverse health effects to
the body's endocrine system. EPA's progress with this screening
program has been slow, but late last year the first 67
chemicals designated for screening were announced, and the
process of collecting information has finally begun. Given the
advancements in science and technology that have occurred over
the last decade, it is appropriate to reevaluate what we know
about endocrine disruptors and assess the effectiveness of EPA
screening program in identifying and evaluating the safety of
endocrine disruptors found in sources of drinking water.
I thank you for coming here today to the witnesses, and let
me turn now to recognize the gentleman from Florida, Mr.
Stearns, for an opening statement.
Mr. Stearns. Thank you, Mr. Chairman, and I ask unanimous
consent that all members have 5 days for submission of their
opening statements.
Mr. Markey. Without objection.
OPENING STATEMENT OF HON. CLIFF STEARNS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF FLORIDA
Mr. Stearns. And thank you for having this important
hearing. Examining the science and the regulation of endocrine
disrupting chemicals that I think all of us are concerned
about. We all take this subject very seriously. There are some
substances in the water that can pose real problems, and I want
to know more about it. I think most members do. I would
particularly like to welcome a constituent. Not oftentimes you
have someone from your congressional district here. Dr.
Christopher Borgart, the president and principal scientist at
Applied Pharmacology and Toxicology Incorporated, which is
located in my congressional district at the home of the
University of Florida in Gainesville. Applied Pharmacology and
Toxicology is one of the leading consulting firms that
specializes in the pharmacological and toxicological effects of
chemicals on living systems. And so I am honored to have a
constituent with that kind of broad-based experience with us
this morning.
As the chairman mentioned, endocrine disrupting chemicals
are natural chemicals that interfere with or mimic the hormones
responsible for growth and development of an organism.
Endocrine disrupting chemicals can be found in commonly used
products such as personal care products, obviously soaps and
cosmetics, industrial by-products, plastic, pesticides, and
pharmaceuticals. As testing has become more sophisticated,
minute traces of certain chemical substances suspected to be
endocrine disruptors have been detected in surface water and
drinking water supplies. These chemicals enter into our
environment from various sources, obviously including
industrial and municipal discharges, agricultural runoffs, and
hospital residues.
And while many researchers agree that field and laboratory
studies of animals providing compelling evidence of the effect
of these chemicals, the scientific community remains sharply
divided of whether organic chemicals are responsible for
increases of certain human cancers, diseases of the human
reproductive system, the immune system, and the thyroid glands.
Nevertheless, environmental advocates have increasingly pushed
for the aggressive federal regulation of the substances.
In 1996, Congress recognized that arbitrary, legislatively
mandated regulation can bog EPA down and delay urgent public
health needs. So to address this, the Safe Drinking Water Act
amendments of 1996 replaced mandatory drinking water
regulations with directions to EPA that it use simply
deliberative rigorous and objective science in making any
further rules on drinking water contaminant levels. EPA and the
scientific community need to continue to study the occurrence
and movement of endocrine-disrupting chemicals in our
environment, and then EPA, not Congress, should set a standard
that best protects the public health.
So, Mr. Chairman, I thank you for this hearing, and we look
forward to the witnesses this morning.
Mr. Markey. We thank you. We thank the gentleman, and we
have with us the gentlemen from Virginia--I am sorry. Chair
recognizes the gentleman from Illinois, Mr. Shimkus, for an
opening statement.
OPENING STATEMENT OF HON. JOHN SHIMKUS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF ILLINOIS
Mr. Shimkus. Thank you, Mr. Chairman. We need to just make
sure that when we go down a route that that is--we are using
high quality science whose results are repeatable, whose
objective is not to answer questions for which we already have
decided the answer. We have a tendency of doing that.
We made some precautionary decisions in the toy bill, and
that has just been one disaster after another. The whole debate
on climate has just been a great exercise in how this climate-
gate thing all unfolded. Science wanted the data to see if the
projections by scientists were relevant and true. These
scientists withheld data. They would not provide those. Under
the Freedom of Information Act, we finally started getting the
data. And guess what.
Are the Himalayan glaciers melting in 35 years? We made a
mistake. What about sea levels? That was a miscalculation. We
have people walking away from or leaving the IPCC. We have the
U.N. guy now stepping down. And why? Because we didn't use
science. We didn't use the scientific method to put the bats on
the table, put data on the table, and do the research to
replicate these assumptions. So we have to be very, very
careful that we don't go down a route.
This is the ``Washington Post'' Tuesday, February 23,
``Replacing BPA cans gives foodmaker fits.'' At the end of
this, it says--they are talking about tuna. They spent
thousands of dollars. Is it in the cutting board? Is it in the
fish? Is it in the tuna itself? We don't know. We are trying to
figure it out. Let us use real science. Let us be able to
replicate the data. Let us just don't go on an emotional
rollercoaster to impinge on our ability to create jobs in this
America which increased regulations always does, and I yield
back my time.
Mr. Markey. The gentleman's time has expired. The chair
recognizes the gentlelady from California, Ms. Capps, for an
opening statement.
OPENING STATEMENT OF HON. LOIS CAPPS, A REPRESENTATIVE IN
CONGRESS FROM THE STATE OF CALIFORNIA
Mrs. Capps. Thank you, Mr. Chairman, and thank you for
holding this hearing on the growing pandemics of endocrine
related health disorders. Like you, I am very concerned about
exposure that may be occurring through drinking water supplies.
I am particularly concerned given the very pervasive nature of
endocrine-disrupting chemicals, which are everywhere in our
environment.
Many of these chemicals are either unregulated or
underregulated and include toxics, pesticides, even
pharmaceuticals. As many of you, I spent my early professional
years as a public health nurse. It is from this experience that
I have been very mindful of threats to human health. While the
Safe Drinking Water Act was successful at controlling some
substances, it is clear that today's contaminants of concern
are not the pollutants of yesteryear.
For example, there are currently 80,000 chemicals in use.
This is a threefold increase from 1941 to 1995. 8,000 of these
are known to be carcinogens. One would hope that all of these
8,000 cancer-causing chemicals are somehow addressed under
federal and state laws, including the Safe Drinking Water Act.
Shockingly, this is not the case. It seems that less than 300
chemicals have permitted limits.
Today's hearing provides us with an opportunity to ask why
this is the case. It is not as if endocrine-disrupting
chemicals are new issues of concern for either Congress or EPA.
Through the Safe Drinking Water Act, Congress instructed EPA to
develop a screening program to determine if certain chemicals
disrupt hormones in humans. In the 14 years since this mandate
was put in place, EPA has begun to test few chemicals under the
program, despite the potential for these chemicals to cause
great harm to individuals, especially to children and pregnant
women.
Today, I hope to hear about where these chemicals are
coming from, what the impact to human and ecological health is,
and what should and can be done to protect us from harm. So I
do look forward to the testimony from our witnesses today on
this very important hearing. And again I thank you for calling
it to order, and I yield back.
Mr. Markey. Thank you. Thank the gentlelady. We see no
other members of the subcommittee seeking recognition for the
purpose of making an opening statement. So we will turn to our
witnesses, but we will begin first with our friend Congressman
Jim Moran who has worked for many years on this issue and who
has joined us here this morning. We welcome you to the
committee, and we look forward to your testimony.
STATEMENT OF HON. JAMES P. MORAN, A REPRESENTATIVE IN CONGRESS
FROM THE COMMONWEALTH OF VIRGINIA
Mr. Moran. Mr. Chairman, thank you very, very much, and
thank you for your leadership on this issue. And it is good to
see my colleagues and friends Ms. Capps and Mr. Stearns. I
first came to be concerned about this when we looked at the
fish in the Potomac River. Now, this is just between northern
Virginia and Washington, D.C., and almost 100 percent of the
fish--they are small-mouth basses--are intersex. They are both
male and female sexual organs. There is something wrong with
that, and so we looked into what might be the cause. And
invariably, we came back to endocrine disruptors.
The problem is that the scientific research is inadequate
to give us the kind of determination that we need to get, but
we have the authority. Back in 1996, the amendments to the Safe
Drinking Water Act call for EPA to ensure testing of chemicals
with endocrine-disrupting effects. Congress directed the EPA to
develop an endocrine-disruption screening program as part of
the Food Quality Protection Act, as Ms. Capps suggested.
Unfortunately, for a number of reasons--I will mention some of
them--this program has not been effective. It has been
deliberately delayed. Here we are 14 years later, and over $100
million has been put into this program. And it wasn't until
October of this past year, just a few months ago, that EPA
announced the availability of the national SAs and its testing
guidelines for a limited number of chemicals.
Chairman Markey, you have been monitoring the progress of
the EPA and performing these studies, and you have been
expressing your concern about the public's exposure to these
chemicals while the issue continues to be studied. We can't
study it forever if we know that people are really suffering
because we haven't been able to come up with determinations on
what is causing it. What is especially frustrating that,
despite slow progress by the EPA, the science has continued to
evolve through robust research by the scientific and academic
communities through basically no help from the EPA who is
charged with this work.
And the work that the scientific community has done
convincingly demonstrates a link between synthetic endocrine-
disrupting chemicals and a number of disorders of the human
endocrine system. It has seriously undermined the health of our
Nation. It is costing hundreds of billions of dollars. Now, it
is autism, hyperactivity disorder, asthma, juvenile and adult
diabetes, juvenile cancer, osteoporosis, Parkinson's,
Alzheimer's. What we know is that these disorders began to
increase noticeably in the early 1970s when the first
generation was exposed in the womb to post World War II
synthetic chemicals. And they reach maturity, and that is when
we see this phenomenal increase in these kinds of disorders.
The endocrine disruptors were a fringe concept a decade
ago. Now, they are accepted by the scientific community. But
think of this, asthma rates have tripled in the past three
decades. One in six American children has a developmental
disorder. One in 59 boys has autism. Cancer is the leading
cause of death among children now. Primary brain cancer has
increased by nearly 40 percent. We know about childhood
obesity. One in two minority children develop diabetes.
Testosterone levels have declined dramatically over the last 20
years.
We have to be concerned about this. Something is happening,
and it is happening on an accelerating pace. The scientific
community is telling us that there is very likely a link to
these dramatic increases in diseases in EDCs. What is
happening, according to an environmental working group, that
analyzed the umbilical cord blood that was collected from
minority infants, they identified industrial compounds and
pollutants that there were complex mixtures of compounds in
each infant. And it shows that industrial chemicals cross the
placenta in large numbers and contaminate babies in the womb.
And it is that synergistic effect of these chemicals that is
likely causing the problem.
In November of this past year, the AMA said that the
federal government needs to minimize the public's exposure to
endocrine-disrupting chemicals. So this is no longer a fringe
issue. This is a very important issue for the entire Nation.
But despite the profound improvements in scientists' knowledge,
the chemical industry, because of legislation that said that
basically all the stakeholders have a veto if they choose to
use it.
The chemical industry, being one of those stakeholders, has
been able to manipulate the process that has been undertaken by
the Environmental Protection Agency so that they could produce
results that were contrary to all of the research conducted by
qualified endocrinologists that have found health consequences
from EDCs.
And through the process of buying up the stakeholders, EPA
has been prevented from using the most appropriate modern
protocols. That is the problem. EPA has not been able to
conduct these experiments in the way that they know they need
to. They have been conducting them in an outdated way. I won't
go into all the details because I suspect your speakers will
describe it. But basically they use this dose response method.
The dose establishes the poison. At higher doses, the effects
are often nullified causing organs to stop producing more
hormones and receptors.
It is in low doses where the damage oftentimes occurs, but
I will let the experts explain that. We have to be using
modern, 21st century testing paradigms that recognize the
unique subtle and complex properties that affects EDCs. I know
that is what you want to be doing, Mr. Chairman.
We need to be guided by the scientific community instead of
stakeholders who we know have a major financial interest in not
allowing EPA to be able to pursue the authority and charge that
the Congress gave it. I don't think I am going to get into the
fact that EPA hasn't done these studies properly, but the
National Institutes of Environmental Health Sciences has the
expertise and the objectivity. And you are going to hear from
them. We strongly support them.
For what it is worth, we have some role in the
Environmental Appropriations Subcommittee. We want to do
everything we can to support your efforts, Chairman Markey.
This is a very important issue. It is affecting tens of
millions of children across the country, and it is more than
past time that we started doing the right thing in finding out
the real impact of these EDCs and how we can get them out of
the bloodstream of American society.
So, Mr. Chairman, thank you very, very much for your
leadership. I really do appreciate it. I appreciate the
opportunity to add my two cents this morning.
[The prepared statement of Mr. Moran
follows:]*************** COMMITTEE INSERT ***************
Mr. Markey. Well, it is more than two cents, and since you
are on the Appropriations Committee, you have a chance to put
in a few more than that too. We thank you so much for your
leadership on this issue over the years, and we thank you for
coming here today. And I would like to partner with you as we
go forward between our two committees to try to find a way that
we can properly fund and properly regulate this incredible lies
in disease that we know is related to something that we are
doing to ourselves would cure most of the diseases that over
the years have afflicted people.
Now we have to deal with issues that we do it to ourselves,
you know, that we just make decisions with regard to chemicals,
with drugs, with alcohol, with overeating. These are things
that here we have a chance, you know, just with preventative
measures to protect against the diseases, and your leadership
has been fantastic.
The gentleman from Florida.
Mr. Stearns. You know I would ask the staff about your
opening statement, and my good friend has been on this issue
for some time. And I have heard you before, and I think many of
us have gone down to the Chesapeake, and so we are a little bit
aware of what happened. And then, of course, we look at the
Potomac occasionally and see what happened there. Many of us
sometimes go fishing on the Potomac, either part of fundraising
events or just social events. And so it is disturbing. I live
in Old Town. I go down to King Street where you were mayor of
Alexandria, and sometimes you get alarmed.
So I think it is an important issue. For all of us, I think
the idea is there hard, repeatable science that can show this?
Because we are asking the federal government to step in. So I
think, Mr. Chairman, that is probably the crucial aspect to see
that there is hard, repeatable science. Thank you.
Mr. Markey. And we thank you again. We very much appreciate
your work and your staff's work on this issue. Now let us turn
to our witness panel, and first of all, the subcommittee has
received several letters and documents related to the subject
matter. And I ask unanimous consent that the materials be
included in the record without objection.
[The information appears at the conclusion of the
hearing.]*************** COMMITTEE INSERT ***************
Mr. Markey. We will turn to our first witness, Dr. Linda
Birnbaum. She serves as the director of the National Institute
of Environmental Health Sciences and the National Toxicology
Program. She is a board-certified toxicologist and has served
as a federal scientist for nearly 30 years. Dr. Birmbaum
previously served for 16 years as director of the experimental
toxicology division of the Environmental Protection Agency. We
welcome you, Doctor. Whenever you feel comfortable, please
begin.
STATEMENTS OF LINDA BIRNBAUM, DIRECTOR, NATIONAL INSTITUTE FOR
ENVIRONMENTAL HEALTH SCIENCES; JAMES JONES, DEPUTY ASSISTANT
ADMINISTRATOR, OFFICE OF PREVENTION, PESTICIDES AND TOXIC
SUBSTANCES, ENVIRONMENTAL PROTECTION AGENCY; GINA SOLOMON,
SENIOR SCIENTIST, NATIONAL RESOURCES DEFENSE COUNCIL; AND
CHRISTOPHER J. BORGERT, PRESIDENT AND PRINCIPAL SCIENTIST,
APPLIED PHARMACOLOGY AND TOXICOLOGY, INC.
STATEMENT OF LINDA BIRNBAUM
Ms. Birnbaum. Thank you. Mr. Chairman and distinguished
members, I am pleased to present testimony on our current
understanding and ongoing research on endocrine-disrupting
chemicals or EDCs. My name is Linda Birnbaum. I am director of
the NIEHS and the National Toxicology Program.
Some endocrine disruptors are naturally occurring, but many
are manmade substances that mimic or interfere with hormonal
signals in the body and therefore alter the normal functions of
tissues and organs. NIEHS has had a long-standing interest in
these chemicals with its support for research dating back to
the beginning of the institute in the 1960s. Over the past 50
years, we have seen increases in health problems such as breast
and prostate cancer, ectopic pregnancies, undescended
testicles, and a 42 percent decrease in sperm count.
These findings along with observations of abnormal sexual
development in frogs and fish and the widespread detection of
endocrine-disrupting chemicals in our bodies lead NIEHS to
increase its research on the effects of these chemicals on
human health.
The detection of numerous pharmaceutical agents and
chemicals with endocrine-disrupting potential in surface waters
around the country has raised concern about drinking water as a
significant route of human exposure.
I would like to emphasize four things about endocrine
disruption. First, low dose. Our endocrine system works on tiny
amounts of hormones that have significant biological effects.
As a result, some chemical exposures, even at low doses, may
disrupt the body's delicate endocrine system and lead to
disease.
Second, wide range of health effects. Endocrine signals
govern every organ and process in the body. That means when
chemicals interfere with endocrine signaling, effects can be
seen in many different conditions and diseases.
Third, persistence of biological effects. We are finding
that the health effects of exposure to endocrine disruptors can
be observed long after the actual exposure has ceased. This is
especially true when exposures occur during growth and
development, processes that are very sensitive to endocrine
regulation.
Fourth, ubiquitous exposure. Because of widespread use as
drugs and components of consumer products, chemicals with
endocrine-disrupting activity are widely dispersed in our
environment often at biologically effective levels, and
exposure to humans is common. This is well-documented by the
CDC National Exposure Report. I will give you a few examples
regarding low dose. For some endocrine disruptors, biological
changes can be seen at low but not at high doses. This is
different from the usual dose response curve which shows
continually increasing responses with increases in dose.
Low doses of BPA and EDC changes brain structure, function
and behavior in rats and mice exposed during critical periods
of development. Regarding the broad range of health effects,
early work on endocrine disruption focused on health problems
such as reproductive cancers that were known to be hormonally
sensitive. More recently, the universe of potential health
effects has grown to include immune function, metabolism, brain
development, and behavior.
Animal studies have identified how exposure to
environmental endocrine disruptors such as tributyltin,
genistein and diethylstilbestrol can cause weight gain later in
life. EDCs have also been linked to cancers, altered behavior,
diabetes, immune dysfunction, reproductive dysfunction, and
cardiovascular disease.
Regarding the persistence of biological effects. Exposure
to endocrine disruptors during development can result in
profound changes in later life. Animal researchers recently
discovered that EDCs can produce these latent effects by subtly
altering the structure of the DNA molecules and chromosomes.
These changes may affect gene expression for several
generations.
NIEHS is also conducting human studies on the latent effect
of EDC exposure including studies of children showing
behavioral, mental, and physical abnormalities who were exposed
to phthalates or flame retardants before birth.
Regarding ubiquitous exposure. The NTP is conducting a
study of triclosan, an antimicrobial that is one of the most
frequently detected water contaminants. Our understanding of
the endocrine-disrupting chemicals has lead to new approaches
for studying EDCs including research on whether mixtures of
chemicals known to occur in drinking water impact development.
Other novel approaches are being developed to characterize
the potential for environment agents to perturb endocrine
function. NTP's high throughput screening initiative and Tox 21
partnership with EPA includes assays designed to assess
activity of chemicals as hormonal targets. Initial results have
shown that EPA and triclosan are among the most active of
hundreds of chemicals tested so far. Such novel screening tests
can be used for a basis for deciding whether to conduct more
intensive animal studies.
To ensure that our science is shared with those who need
it, we are partnering with the agencies that use our research,
and we are sponsoring scientific forums for sharing this
information with affected communities and stakeholders. For
example, our breast cancer and environmental research program
distributes fact sheets for clinicians and the public on likely
sources of EDC exposures.
In conclusion, I believe this area of environmental health
sciences to be of utmost importance. Our endocrine systems keep
our bodies in balance, maintaining homeostasis and guiding
proper growth and development. With NIEHS's leadership, we are
all learning more about how these finely-tuned systems are
sensitive to unanticipated effects from chemical exposure.
This information is critically important for creating
effective strategies to ensure safe drinking water and the
health of the American public. I welcome your questions.
[The prepared statement of Dr. Birnbaum
follows:]*************** INSERT 1 ***************
Mr. Markey. Thank you, Dr. Birnbaum, very much. Our next
witness, James Jones, who is Deputy Assistant Administrator of
the Office of Prevention, Pesticides and Toxic Substances at
the Environmental Protection Agency. He is responsible for
managing the daily operation of the office which oversees the
Nation's pesticide, toxic chemical, and pollution prevention
laws. He previously served as the director of the agency's
office of pesticide programs. We welcome you, sir.
STATEMENT OF JAMES JONES
Mr. Jones. Good morning, Mr. Chairman.
Mr. Markey. Move that microphone in a little bit closer
please.
Mr. Jones. Good morning, Mr. Chairman and members of the
subcommittee. I am Jim Jones, the deputy assistant
administrator of EPA's Office of Prevention of Pesticides and
Toxic Substances. I appreciate the opportunity to appear before
the subcommittee to provide an update on EPA's endocrine-
disruptor screening program and plans for its future
implementation.
The implementation of the EDSP is part of one of
Administrator Jackson's top priorities. To make significant and
long-overdue progress in assuring the safety of chemicals.
Issuing test orders for the generation of data to better
understand potential endocrine effects is an important step in
improving our ability to protect the public health and the
environment from chemicals.
The Food Quality Protection Act of 1996 required EPA to
develop and implement a program to screen all pesticides for
any effect in human that is similar to effects produced by
naturally-occurring estrogen and such other endocrine effects
as EPA may designate.
Upon the recommendations of our advisory committee, the
EDSP was expanded to include the assessment of androgen and
thyroid hormone systems and effects on wildlife. The EDSP is a
two-tiered screening program. Tier one is composed of a battery
of 11 invitro and short-term invivo assays to identify
chemicals that have the potential to interact with estrogen,
androgen and thyroid systems. Chemicals that are positive in
tier one would be subject to the tier two testing requirements.
The purpose of the tier two test is to provide information
that can be used as a risk assessment such as identification
and characterization of adverse effects resulting from the
interaction of the chemicals with the hormone system and
exposure levels required to produce them in assays involving
developmental life stages in whole animals.
The validation of the tier one assays took far longer than
anyone in EPA anticipated. Because of the many complexities of
methods developed in the validation for such a large number of
assays, validation of tier one assays took 10 years and is
still ongoing for tier two assays. Validation of the tier two
assays will be complete in 2012.
The good news is that the EPA has begun to issue test
orders. The first list of chemicals for testing consists of 67
chemicals, 58 pesticide active ingredient and 9 inert
ingredients that are also high-production volume chemicals.
EPA began issuing its first EDSP test orders in October of
2009, and it will issue the last test orders for list one
chemicals this week. A total of 750 plus test orders will have
been sent to manufacturers of these 67 chemicals. EPA has
created a database of the initial pesticides chemicals to be
screened in the EDSP and has made this information available on
EPA's Web site.
In addition to the EPA provisions that require the
screening of all pesticide chemicals, the Safe Drinking Water
Act amendments of 1996 provide EPA with the authority to test
substances that may be found in sources of drinking water, to
which a substantial population may be exposed. Right now, EPA
is preparing a second list of no less than 100 chemicals, a
draft of which will be released in the near term.
The list two chemicals will be drawn from three sources:
national primary drinking water regulations, the Contaminant
Candidate List, CCL 3, and pesticides that are on the
registration review schedule in the near term. The CCL 3 list
is a list of contaminants that are currently not subject to any
proposed or promulgated national primary drinking water
regulations that are known or anticipated to occur in public
water systems, and which may require regulation under the Safe
Drinking Water Act. The CCL 3 list includes pesticides, other
chemicals used in commerce, and disinfection byproducts and
degredates.
In summary, EPA is on track to obtain tier one endocrine
screening data on several hundred chemicals within the next
several years. Although it has taken a long time to develop the
tests necessary for this program, we have begun to meaningfully
implement the EDSP and allow to expand the universe of
chemicals for testing beyond pesticides to include drinking
water contaminants.
Thank you for your continued interest in this program, and
I would be happy to answer any questions.
[The prepared statement of Mr. Jones
follows:]*************** INSERT 2 ***************
Mr. Markey. We thank you, Mr. Jones, very much. Our next
witness is Dr. Gina Solomon, who is a senior scientist in the
health and environmental program of the National Resources
Defense Council, and is a specialist in adult internal
medicine, preventative medicine, and occupational and
environmental medicine. Dr. Solomon also serves as an associate
clinical professor of medicine at the University of California
at San Francisco where she is the director of the occupational
and environmental medicine residency program and the associate
director of the ECSF pediatric environmental health specialty
unit. So we welcome you, Doctor. Whenever you are ready, please
begin.
STATEMENT OF GINA SOLOMON
Dr. Solomon. Good morning, Mr. Chairman and members of the
subcommittee. Thank you very much for the opportunity to
testify today. You introduced me very well, but I also want to
mention that I was on the EPA's endocrine disruptor screening
and testing advisory committee from 1996 to 1998 and was
therefore involved in the early stages of the EDSP program. I
now serve on the EPA science advisory board drinking water
committee, and as such, have been involved in reviewing EPA's
efforts on drinking water contaminants.
Some years ago, I was invited to speak at the Riverside
County Medical Association. It is in southern California in an
area where a chemical called perchlorate had recently been
detected in drinking water. The local physicians were
concerned, and I went and gave them a talk about the health
data at that time on perchlorate, including the fact that
perchlorate was known to block uptake of iodine into the
thyroid gland and thereby disrupt the thyroid's ability to
create normal thyroid hormones.
And I also reviewed the science on how subtle disruption of
thyroid function in fetal or early neonatal life can
permanently alter normal brain development. Finally, I
described the multiple sources of perchlorate pollution in
clean water contamination from rocket fuel and fireworks
manufacturing, and I closed by sharing some of the latest
monitoring data, which showed that 402 public water systems
serving 40.8 million people in 27 states, the District of
Columbia, and two U.S. territories had perchlorate in their
treated water or in their water sources, and California had the
largest number of systems with perchlorate detections, over 180
at that time.
After my talk that day, an elderly physician in the
audience stood up and explained that he had spent his entire
career treating patients with thyroid disease in this
community. And he said now we learn that something in the water
supply may be contributing to this problem. What am I supposed
to do about it? And more importantly, what am I supposed to
tell my patients about it? He said should I tell them not to
drink the water?
And he further went on to say that he wasn't a fan of big
government, but in this case, he said, we need to get
government involved to deal with this problem. And I agree with
him because this is not something that health care providers
and their patients can deal with alone. This is EPA's job.
Over 5 years have passed since the day when I spoke at that
medical society, and although California and other states have
taken some action on this known endocrine disruptor, EPA has
still failed to act. Meanwhile, there are other chemicals that
are known or suspected endocrine disruptors that have been
turning up with increasing frequency in water. Studies by the
U.S. geological surveys toxic substances hydrology program have
revealed that an unsavory mixture of pharmaceuticals, steroid
hormones, unregulated pesticides, flame retardants, rocket fuel
chemicals, plasticizers, detergents, stain repellents in both
surface water and ground water that we rely on for drinking.
For example, the USGS surface water study found a median of
seven and as many as 38 chemical contaminants in any single
water sample. And among the chemicals that were most commonly
detected in this national survey were many known and suspected
endocrine disruptors, some pesticides, triclosan, alkylphenols
and alkylphenol polyethoxylates, bisphenol A, phthalates and
steroid hormones. And unfortunately so far, the response to
these water findings has tended a bit more toward killing the
messenger rather than acting on the message. Over the most
recent years, funding for the USGS water monitoring programs,
already small, has been reduced, resulting in major cutbacks in
water quality sampling and less data to inform science-based
decisions.
Meanwhile, over a decade has passed since EPA has
promulgated a single regulatory standard for a chemical
contaminate in drinking water. Now there is a large and growing
backlog of chemicals like perchlorate that still have no
regulatory standard, and then there are others that were
regulated over a decade ago whose standards are outdated and in
need of revision. For example, one endocrine disruptor ethylate
known as DEHP, which stands for dyethol hexophthalate, does
have a maximal contaminate leveler in MCL in drinking water,
but it is terribly outdated.
Now, these phthalates like DEHP are used in an enormous
range of products such as cosmetics, personal care products,
vinyl, medical devices, inks and adhesives, and they are also
used as inert ingredients in pesticides and until last year,
were in plastic toys.
National monitoring studies have reported phthalates in
about 10 percent of surface water samples taken. And these
chemicals cause lower testosterone levels, decreased sperm
counts and lower sperm quality in animals, and exposure to
phthalates during development can cause malformations of the
male reproductive tract and testicular cancer. Preliminary
studies in humans also show abnormalities in male reproductive
development.
Mr. Markey. If you could sum up please.
Dr. Solomon. Sure. The MCL for DHP was set in July of 1992
and was based on gastrointestinal disturbances, nausea, and
vertigo. It is not likely to protect against endocrine
disrupting effects. Other chemicals like bisphenol A also have
no MCLs at all.
So in summary, there are numerous steps that EPA should be
taking to implement testing under the endocrine disruptor
screening program for priority drinking water contaminants,
implementing aspects of the endocrine disruptor screening and
testing advisory committee report that have been ignored, and
improving wastewater and drinking water treatment. So thank you
very much.
[The prepared statement of Dr. Solomon
follows:]*************** INSERT 3 ***************
Mr. Markey. Thank you, Dr. Solomon, very much. And our
final witness, Dr. Christopher Borgert is the president and
principal scientist of Applied Pharmacology and Toxicology
Incorporated, a consulting firm that specializes in assessing
the pharmacological and toxicological effects of chemicals on
living systems. Dr. Borgert received his doctorates in medical
science from the University of Florida College of Medicine. We
welcome you, sir.
STATEMENT OF CHRISTOPHER J. BORGERT
Mr. Borgert. Thank you, Mr. Chairman.
Mr. Markey. If you can turn on the microphone and move it
in closer please. There we go. Thank you.
Mr. Borgert. Thank you, Mr. Chairman. Thank you for giving
me the opportunity to provide you my perspectives on this
important issue. I come to you today speaking for myself. I
don't represent any particular entity, but I do come to you as
a father and as a consumer, as a taxpayer, as an operator of
small business, and a scientist with considerable background on
this issue.
And I too am very concerned about the chemicals that we use
in commerce. I want to make sure that my family and my children
and the people of Florida and all the people that come into
contact with those chemicals are protected. That is a very big
concern to me. That has been a large part of my work over the
years. But I am most concerned that when we act, we do it based
on solid science, science that is reliable and relevant for the
purpose to which we put it. And what I would caution you about
is that many of the decisions that are being urged to be made
are being urged to be made on the basis of someone's latest pet
theory on what is causing certain human diseases, rather on
solid, repeatable data.
Let us remember that the diseases that were touted to be
due to endocrine disruption a decade or so ago have shifted. So
as some theories fall by the wayside, new theories replace
them. These are theories. We don't know what the punitive
results of endocrine disruptors will be in a few years, and so
I think it is very important that we use solid science.
What do I mean by solid science? I mean science that
comports with three very common sense tenets: that we know what
we are measuring unequivocally and we know the precision of
that measurement. These are very common sense rules. Number
two, that we know our measurements are taken under controlled
conditions that are relevant for the purpose we are putting
them to. And third, that they are repeatable in independent
hands.
Now, the endocrine screening program that is at issue here
has been through such a validation exercise, but let us be
clear. That validation really was able to address only the
first of my three tenets. So we now have some confidence that
those assays measure what we believe they are measuring and we
know something about the precision. But for some of the assays,
that isn't even entirely clear.
Two of the assays, for instance, failed to produce negative
results in a wide array of chemicals that we might expect to be
negative. So we are not really sure that the results are
relevant to the use we are going to put them to. We don't know
that they won't simply move everything forward with positive
results and a screen that doesn't differentiate between what
should be moved forward to tier two testing and what is a very
low priority for tier two testing is rather useless.
The EPA has issued test orders for 67 chemicals. Its
science advisory panel back in 1999 advised that it do this,
and we just heard that that will be complete in 2012. That will
hopefully complete the validation exercise so that we will know
the controlled conditions under which our measurements have to
be made and whether they are relevant and useful for actually
deciding which chemicals need to be tested and which are a
lower priority.
So my recommendation is to allow that science to occur,
allow EPA the time, to give them the resources they need to
formulate the criteria for moving chemicals forward based on
the data, not based on the level of emotion and the latest
concern, but based on the data. We don't know what those data
will be until they are collected. Allow that process to go
forward, and I think that then we may emerge with science that
we can rely on. And remember there are consequences to getting
it wrong.
Decisions about which chemicals are in commerce, if they
are made based on a false notion of what the risks, the real
risks are, can be the wrong decisions and actually not be
precautionary. Bad decisions can imperil the public health and
the environment rather than protect it. So there are
consequences to getting it wrong. I urge you to give EPA the
time to get it right. And thank you for your attention. I very
much appreciate being able to provide my perspectives.
[The prepared statement of Mr. Borgert
follows:]*************** INSERT 4 ***************
Mr. Markey. Thank you, Dr. Borgert, and thank you for being
here. That concludes testimony from our panel. Now we will turn
to a question-and-answer period. The chair will recognize
himself for a round of questions.
I have introduced a bill to ban BPA in food and beverage
containers in the past two Congresses, and recently the FDA
announced that it had concerns about its health effects. It has
also been found in 30 percent of groundwater sites sampled
nationally.
Dr. Birnbaum, the endocrine-disruptor screening program is
intended to screen chemicals to see whether they are endocrine
disruptors, but it seems to me that we already know that BPA
qualifies. Do you agree with that?
Ms. Birnbaum. I certainly support the recent decision of
the EPA to suggest that they have some concern about the
effects of BPA, which are based in large part upon the plethora
of information that is being produced demonstrating that BPA is
an endocrine disruptor and is associated with, at least
potentially associated with a wide range of health effects.
Mr. Markey. Dr. Jones--Mr. Jones, do you generally agree
that if there is enough scientific data showing that a chemical
is an endocrine disruptor that causes adverse health effects,
that EPA shouldn't have to screen it again and could use its
authority to move straight to regulation?
Mr. Jones. Well, I would generally agree that the agency
would not need to do screening level assessments to determine
whether it is an endocrine disruptor, BPA being a perfect
example. We don't think that that requires screening to
understand whether it is. I don't believe as a general matter
we necessarily will therefore have enough information to go to
regulation. I think that is the situation where we need to make
sure we understand we can characterize the adverse outcomes of
a compound before we can go to regulation.
Now, that may not be true in all cases, but I think it
would be an overstatement for me to say I think that we can go
from we know it is a disruptor to regulation as a general
matter.
Mr. Markey. Dr. Solomon, since BPA is a known endocrine
disruptor that is known to be in drinking water, do you think
EPA should have included BPA on its list of chemicals to
evaluate to consider whether a drinking water standard should
be set for it?
Dr. Solomon. Yes, I do.
Mr. Markey. Could you expand on that briefly please?
Dr. Solomon. BPA fits the criteria--clearly fits the
criteria for a priority substance for regulation in drinking
water because it is, a, known to be present in drinking water
source waters, and, b--and actually in some studies in drinking
water at the treatment plant, and, b, is a chemical that has
very strong data on health effects at levels that are actually
not that far off from what people are being exposed to today.
Drinking water is not the only source of exposure, but it is
certainly something that EPA can and should be controlling.
Mr. Markey. OK, a recent press article, Dr. Solomon,
suggested that EPA did consider including BPA on its list of
chemicals of concern, which would put it into the regulatory
process. But it was pulled off the list shortly after the
chemical industry met with OMB. Do you think that EPA should
decide which chemicals to evaluate using a process that is more
transparent and gives more opportunities for all stakeholders
to participate?
Dr. Solomon. Yes, I believe it is extremely important for
EPA to have more public involvement in the process, and the
candidate contaminant list was not vetted until it was pretty
much almost a done deal. And there were some significant
concerns raised by members of the public and by the drinking
water committee about the list itself and the chemicals that
were not on and were on that list.
Mr. Markey. Mr. Jones, what can you tell us about why BPA
was not included on EPA's list of chemicals of concern?
Mr. Jones. Well, first, Mr. Chairman, I do want to point
out it is a public record because what we submit to OMB is made
public, and what comes back out of that process is public as
well. And BPA was not on the list when it went to OMB, so a
characterization that it was removed through that process would
just not be accurate.
My understanding is that BPA, when the agency did the CCL 3
list, did not meet the criteria we had in terms of our
understanding related to the known health effects associated
with it. It is found in drinking water, but that the knowledge
we had related to known effects associated with the compound,
it did not meet the criteria that we use for listing chemicals
under CCL 3.
Mr. Markey. And back to you for a final question, Dr.
Solomon. We often hear that the European Food Safety Authority
thinks that BPA is safe and that we therefore don't need to
worry about it in this country. However, just a few days ago,
the Danish parliament voted to ban BPA in children's products,
and a spokesperson for the European commission indicated it is
looking at new scientific evidence.
Do you agree with the European Food Safety Authority's
current policy on BPA? And if not, what did it get so wrong?
Dr. Solomon. The European Food Safety Authority's review of
BPA was based on a fairly limited review of the data that
focused on a number of the studies done by industry, and it
unfortunately did not include many of the most important
independent studies done by academics. And so, I am very
pleased to see that the Danish authorities and that others,
such as the Canadian government, have been reevaluating the
science more fully, that the FDA is doing so as well because
there is really a very extraordinary amount of science showing
a serious concern related to health effects at low levels.
Mr. Markey. Thank you, Dr. Solomon. Chair recognizes the
gentleman from Florida, Mr. Stearns.
Mr. Stearns. Thank you, Mr. Chairman. Dr. Borgert, the
chairman brought up this BPA, and he has made quite significant
statements on it. In your opinion, should BPA be totally
banned? I know it is omnipresent in very small quantities in
everything from eyeglasses to liners in cans and everywhere. So
I mean I will just give you a chance to respond since he has
asked these three witnesses, what your opinion is.
Mr. Borgert. Well, thank you, sir. I have not formally
reviewed all of the data on bisphenol A, but I know that it is
still controversial among some. But I know that a number of
well-qualified groups that have determined that at the levels
people are exposed to and that are in the environment in the
food supply, et cetera, are present at levels that are unlikely
to pose any significant human risk. And they do that not based
on limited studies. They do that based on studies on comport
with generally those three tenets that I explained.
It is important not only that we look at the quality of the
data, but we look at the quality of the methods we are using to
select the relevant data. And so when you select the relevant
data that are of high quality, you don't come out with an
answer that BPA is a significant health concern. You come out
with a different answer, and many well-qualified groups have
done that.
So no, I think it would be a mistake to rush to regulation.
I think we need to use the best science, and that science needs
to be vetted not on the basis of stakeholder opinions but on
good science.
Mr. Stearns. So in your opinion right now there has not
been the scientific study done to totally ban it? Is that----
Mr. Borgert. I don't think the science would support that.
Mr. Stearns. OK, so it is your opinion that science would
not support the total banning of the BPA as the levels we are
using it today in America?
Mr. Borgert. Correct.
Mr. Stearns. Is that your opinion? And has there been any
demonstrable evidence that in the levels we are using it, any
science to show that it is harmful in the levels we have? Where
is the people that are saying for the ban? Where are they
getting their evidence to say it needs to be banned? You have a
Scandinavian country saying they are banning it. So there must
be some scientific evidence somewhere to back it up?
Mr. Borgert. Well, there are many, many studies conducted
on BPA that can be used to raise concern.
Mr. Stearns. As well as to raise not concern.
Mr. Borgert. As well as to raise questions.
Mr. Stearns. Yes, so there are all studies across the
spectrum is what you are saying?
Mr. Borgert. That is correct, but when we select the
highest quality studies that are most relevant for the
question, we don't come up with the answer that it poses a risk
and that it should be banned.
Mr. Stearns. Why do we use it so omnipresent everywhere? It
is because it works in an efficacious way?
Mr. Borgert. Well, it is a plasticizer that enhances
physical properties of the plastics. I am not a chemist who
could----
Mr. Stearns. No, I understand.
Mr. Borgert. --explain that to you fully. But there are
benefits to the products that are in the marketplace, and if we
choose different alternatives, they may not confer the same
benefits. We may actually incur real risks like bacterial
infections, et cetera, if our products are less effective.
Mr. Stearns. Let me go to the heart now, the hearing we
have here. So far, what chemicals are classified as proven
endocrine disruptors in human? I mean that have been
scientifically proven to be disruptors in humans? Do you know?
Mr. Borgert. Well, I haven't prepared a list, and so I
would hesitate to go on the record and provide one, but----
Mr. Stearns. Sixty-seven are being studied by the EPA. And
then some of those have been pulled off. But I mean do you have
a list in your own mind's eye of the number of disruptors that
actually could be classified?
Mr. Borgert. Well, no, and I think that is a large unknown
at this point.
Mr. Stearns. So it is still unknown. I mean regardless of
what we hear, testimony and so forth, but there is nobody that
scientifically has classified as proven endocrine disruptors in
any studies that affect humans. Is that true?
Mr. Borgert. Well, it is not that there are no chemicals
that I think we could call endocrine disruptors. I think
diethylstilbestrol is a classic example. I think that many of
the drugs that we use today are used for their hormonal
activity and that at that certain doses in certain people are
certainly going to disrupt the endocrine system.
I think that other chemicals in very high doses may be able
to do that, but we have to consider two things: the dose and
the potency. In other words, how much of it there is and how
strong it really is. So doing animal studies where we give
doses that may not reflect the human situation or the human
physiology are not able to tell us whether a compound is an
endocrine disruptor in humans.
And I want to clarify that the endocrine disruptor
screening program won't do that for us either. It is a screen.
It simply tells us which chemicals really deserve a close full-
fledged definitive test and which are of lower concern. We
don't even know that the battery is going to be effective for
that yet until the data from this first 67 comes in and we have
time to digest it.
Mr. Stearns. OK, my questions are over. Based on what you
are saying, we don't--also the dosage at which they are
damaging is very crucial is what you are saying. And that is
part of this whole difficult challenge is to get a hold of, oK,
this chemical is bad, but at what dosage is it bad? And that is
probably what you are alluding to. Thank you, Mr. Chairman.
Mr. Markey. Thank the gentleman. The gentleman's time has
expired. The chair recognizes the gentlelady from California,
Ms. Capps.
Mrs. Capps. Thank you, Mr. Chairman. I mentioned in my
opening statement my background as a public health nurse. And
working so many years as I did with my local public health
department--and I know this to be the case amongst many public
health agencies throughout our local communities across the
country--this is a very important topic to our local health
directors and facilitators.
I want to ask several of you short questions, if I could,
back and forth way. Mr. Jones, starting with you. I am
concerned that the screens that EPA is using to test a very
short list of possible endocrine disruptors will not even begin
to capture the long list of chemicals being reported in
drinking water supplies today. This is a bit of a repeat to
what the chairman has already asked you, but I want to get it
clearly on the record.
Once an endocrine disruptor is identified through your
screening, will that be adequate to regulate it?
Mr. Jones. The first step in the process is to screen for
potential interactions with the endocrine system. Chemicals
that come out of that process as positive will then go into a
more in-depth testing regime that it is that information, a
tier two test, that will give us the information that is
necessary for regulating.
Mrs. Capps. So after tier two, then you can regulate?
Mr. Jones. That is correct.
Mrs. Capps. How long does that process take usually?
Mr. Jones. Going from today the 67 chemicals that have been
tested up through having the results of the tier two test is
going to be about five plus years.
Mrs. Capps. Five years?
Mr. Jones. That is correct.
Mrs. Capps. That is remarkable. Dr. Solomon, what steps are
necessary to determine if regulation is needed once an
endocrine disruptor is identified through screening? You talked
about this in your statement.
Dr. Solomon. When an endocrine disruptor is identified, you
know, I think there is a public health imperative to take
action.
Mrs. Capps. Immediately?
Dr. Solomon. And so, you know, the EPA moves at its own
pace, but it really needs to move quickly on these chemicals.
And the ones that are known endocrine disruptors, that have
been sort of sitting in the queue----
Mrs. Capps. Yes.
Dr. Solomon. --or even put back into the queue, for
example, numerous phthalates that I would already classify as
known endocrine disruptors are now going through the first tier
of screening, entering 5 five-year process at a point when they
actually should be gainfully heading toward regulation.
Mrs. Capps. Well, you know, and the interesting thing is
when the public knows, when the parents of the school kids I
used to work with understand that there is a problem, they
don't want to wait 5 years. Their children will be adults by
then, and the damage will have been done. So I hear your
urgency.
Back to you, Mr. Jones. Does the Safe Drinking Water Act
provide EPA with the necessary mechanisms to regulate the
chemicals being identified as endocrine disruptors?
Mr. Jones. The Safe Drinking Water Act provides the
necessary tools to do that. I will point out that the testing
for endocrine disruption under the Safe Drinking Water Act was
discretionary authority, which, I think, probably explains why
it has not been----
Mrs. Capps. Do you believe it should be discretionary?
Mr. Jones. I will leave that up to----
Mrs. Capps. OK.
Mr. Jones. --Congress. We are now exercising our
discretion, but it was discretionary in that we----
Mrs. Capps. I hear you. Back to you, Dr. Solomon. Do you
think EPA has an effective mechanism to regulate the chemicals
being identified as endocrine disruptors? And if you don't,
what should that mechanism be?
Dr. Solomon. One of the problems with endocrine disruptors
that came up was this issue of low doses, and EPA's regulatory
mechanisms in general are not very good at dealing with the
kind of unusual data where a chemical may have one set of
effects at a high dose and a different set or even more severe
effects at low doses at key periods of infant development. And
this is really where we, you know, where the regulatory system
stumbles.
Mrs. Capps. And where groups like yours and Dr. Birnbaum's
can be perhaps useful in updating some of the procedures? That
was a question kind of.
Dr. Solomon. Yes, I certainly hope and believe that EPA is
starting to look at these issues more seriously in all of the
environmental media.
Mrs. Capps. Dr. Birnbaum, I want to make sure that--because
you have been nodding as I have been asking other questions.
Does NIEHS have the capacity to provide the science and the
protocols needed to regulate the chemicals being identified as
endocrine disruptors?
Ms. Birnbaum. NIEHS has a long-standing program in studying
endocrine disruptors. In fact, in 2007, we convened a panel of
over about 35 different experts from across the country and
across the world looking, for example, at the issues of BPA.
And the consensus of that panel was that BPA was an endocrine
disruptor and was causing effects in multiple different animal
species, not just rats and mice, and that there was evidence
that there was at least the potential to cause those effects in
humans.
Since that time, the NTP Seer Panel has issued the report
which again was an extensively peer-reviewed report involving
many experts, which concluded that there was some concern for a
number of developmental and reproductive endpoints including
development neurological effects following exposure to BPA.
At the same time, we have continued to fund additional work
to look at the issues not only of BPA, but of many other
endocrine-disrupting chemicals. So I would say that there are
demonstrated endocrine-disrupting effects of a number of
chemicals in humans. There are now several epidemiology studies
that cannot prove causality but can demonstrate associations
between, for example, BPA and developmental neurobehavioral
changes in children between cardiovascular effects, between
diabetes, for example. Again associations, but they are backed
up by our animal studies.
I think one point I would like to make is that we need to
be careful when we talk about low dose. What I think many of us
should be meaning when we talk about low dose are what are the
levels that are present in people. So the epidemiology studies
I referred to BPA, for example, are being seen in the general
population. These are not necessarily high levels of exposure.
And when you do animal studies, what you really need to
understand is not how much you give the animal, not how much is
in the drinking water, but how much is in the animal if you
want to compare the effects in animals to the effects in
people. And under those conditions, we often find that the
puditive high-dose animal studies in fact are not high dose at
all.
Mrs. Capps. Thank you, Mr. Chairman, for allowing this to
go forward. It appears to me, if I could just put these
comments that the three of you have made together, that the
scientific community in many resources in many settings has
done a lot of studies that could be very useful to the EPA in
terms of perhaps updating or looking in more depth at what the
sciences has out there and that would be very valuable for the
public to have the benefit of. Thank you very much.
Mr. Markey. The gentlelady's time has expired. The chair
recognizes Dr. Burgess from Texas.
Dr. Burgess. Thank you, Mr. Chairman. And, Mr. Chairman,
just for a point of clarification, have you introduced a bill
to ban the EPA or BPA? Because I was almost ready to sign on to
your bill----
Mr. Markey. I know that the governor's race in Texas is
turning on that question, oK. It is amazing watching it from
afar.
Dr. Burgess. Thank you for that clarification. Dr. Borgert
and perhaps Dr. Solomon as well, Mr. Stearns was questioning
you just a moment ago. We were kind of getting into the
questions between dosage and potency, Dr. Borgert. Dr. Solomon,
you were either nodding your head or shaking your head while
that was going on. Did you have something you wanted to add to
that discussion about the discussion of potency and dosage?
We all know anything in the wrong dosage, water
intoxication can happen. Water is generally regarded as safe,
but there are people who are injured, and in fact, there have
even been deaths from overdoses of just simply water. So what
about this issue of dosage and potency?
Dr. Solomon. Hormones are almost unique in the way that
they act in our bodies because there are receptors on our cells
that are basically sort of scanning our bloodstream for even
minute traces of these hormones. And those receptors are primed
basically hugely magnify the cellular and organ system response
in our bodies to even slight hormonal fluctuations.
So actually it is almost like a megaphone into the cells in
our bodies when even a trace amount of a hormone enters our
bloodstream, and that is true of natural hormones. It also is
true of many endocrine disruptors.
Dr. Burgess. I don't mean to interrupt, but I have only a
short period of time. And you know how testy the chairman is
with the person who sits immediately to his left. There is also
a question of how rapidly that compound is metabolized in the
body. Some are metabolized rapidly. Some will tend to have a
cumulative effect. That may have been what Dr. Birnbaum was
just referring to, that there are some things that will just
sequester in the body and leave only more slowly. And, in fact,
there may be populations where this behaves differently as we
learn more and more about medicine.
There may be people who are--I think this is some of the
things we have learned about Gulf War syndrome and how quickly
people are able to metabolize or not metabolize some of these
organic phosphate compounds. So that is a lot of stuff to have
to put into the equation. Dr. Borgert, did you want to say
something about that?
Mr. Borgert. I do. Thank you. Potency is important, but it
is potency at the receptor. And the hormone system is not
unique in utilizing receptors. The neurological system uses the
same concept. So the receptor-based physiology, receptor-based
pharmacology is actually, you know, a cornerstone of the way we
understand many systems work. And it is the potency of the
molecule of the drug or the chemical at that receptor that is
important.
I want to put this into perspective for you. A very fine
study by a scientist, the group Katsenel and Bogens Group, not
working on endocrine disruptors per se, but looking at steroid
hormone receptors showed that testosterone can activate the
estrogen receptor. Now, testosterone is the basic male hormone.
It is not an estrogen, but at its very low potency at the
estrogen receptor, but it can activate it.
And so we need to consider these potency issues, and we
need to remember that these low-dose theories are theories. In
some instances, they may tell us that compounds are having
adverse effects. In other instances, the import of those low-
dose effects may be compensatory and adaptive and merely tell
us that the system is working well to manage the tens of
thousands of chemicals that we experience in our natural
environment as well as the synthetic chemicals. Thank you.
Dr. Burgess. It has been a while since I have dealt with
the biochemical aspects of this, but there are also places in
the body where, in an extraglandular way, hormones can be
produced in fat cells, for example. Estrogen can be--under the
right circumstances, fat cells, adipose cells can produce
estrogen if they are given the right precursors in the right
setting.
The reason I am bringing all this up is we passed a bill in
the last Congress, H.R. 4040, the Consumer Products Safety
Improvement Act, and the unintended consequences of that. The
bill passed for the best of reasons. I voted for it. We passed
that bill, and the unintended consequences have just been
extremely disruptive for the American people that have to live
under the legislation that we passed.
I have motorcycle dealers who sell motorcycles that are
designed for young people, youth motorcycles, which they are
now not sure that they can sell because of the battery is taken
out of the motorcycle and ingested, the lead levels, of course,
would be horrendously high. And under the language of the bill,
the lack of flexibility that we built into the language of the
bill, I have motorcycle dealers in my district that tell me
they have vast quantities of inventory that they can do nothing
with. They can't send it back. They can't sell it. They can't
even sell parts to people who have previously purchased devices
and come in for help.
So it gets to your point, Dr. Borgert, about being so
careful about this not wasting resources on chasing things that
may be of minimal to no impact. But also then the downstream
consequences of legislation are significant. There are some
crystals that might have lead in them only if you pulverize
them to a fine powder and ingest them. And, of course, the
molars of a very young child are not capable of that level of
grinding even if they were to ingest the rhinestone. There are
multiple examples, and I have people through my office all the
time who come and tell me about the bad things I did while I
was trying to be protective of the public good with the CPSIA
through this committee. You like you wanted to say something to
that.
Mr. Borgert. Well, I just wanted to agree, and I wanted to
summarize, I think, what you are saying is, you know, there is
always time after we realize we have made a mistake to go back
and correct it. We have to do that. It is a shame there is
often not enough time to be deliberative and get it right the
first time. And I think we want to take that lesson here.
Dr. Burgess. Well, the other part of the lesson is with the
change of administrations and the change of people at the
Consumer Product Safety Commission, we haven't made those
changes. And we have left people hanging with either inventory
that they cannot sell, resale shops that don't know because of
the level of lead testing we have required is not even
available in some areas. Can we resell these books or toys?
Libraries that don't know if they can leave vinyl-covered books
on their shelves.
It is a huge problem that we created in this committee, and
2 years later, we are not even talking about fixing any of
those problems. And the agency now with a different head--and
not that they are not good people--but the agency is focusing
on new things and not looking at correcting the problems that
we caused.
This is one problem the Bush Administration didn't cause.
Yes, he signed the bill, but we caused the problem. And it has
not been fixed.
Can I just ask one additional question? With all the
stimulus money we spent on computer IT, and you referenced a
lot of the data, Dr. Birnbaum, that you have. Are you getting
that stuff electronically in a place where you can search it
and where those databases are actually going to be useful to
you? Because you have collected a lot of data. You are
continuing to collect a lot of data. But is it in a format that
will actually be useful to us?
Ms. Birnbaum. Thank you very much for the question. All
the, for example, published studies are available
electronically on the Web site. All the approximately $10 to
$15 million that we are funding under the American Recovery and
Reinvestment Act, all the information about what those studies
are, who has conducted them, what these objectives are of those
studies, are available on the usagovernment.recovery Web site
as well as on our NIEHS Web site. And those results, as they
come to fruition, will all be available for the general public.
Dr. Burgess. What sort of backlog do you have with putting
data in there?
Ms. Birnbaum. Excuse me?
Dr. Burgess. What sort of backlog do you have with putting
the data in there?
Ms. Birnbaum. It goes on almost as soon as it becomes
available.
Dr. Burgess. The historical that has been collected.
Ms. Birnbaum. All the historical data is currently
available right now.
Mr. Markey. OK, the gentleman's time has expired. We thank
the gentleman for identifying a problem that was not created
during the Bush Administration. That is also very helpful, I
think, historically. The chair recognizes the gentleman from
California, Mr. McNerney.
Mr. McNerney. Thank you, Mr. Chairman. I am recovering from
laryngitis so I don't know if I have 8 minutes of voice or 9
minutes to compete with the gentleman from Texas, but I will
give it a shot. I am glad that he was as concerned about your
testiness on this issue as he is.
Mr. Jones, we have a town in my district, Morgan Hill, that
has a large perchlorate spill in the region. Now, California
has set pretty good standards for perchlorate, but there is no
national standards in place. Do you think that would be a good
idea to move forward with a national standard for perchlorate
and other endocrine disruptors?
Mr. Jones. Thank you, Mr. Congressman. The agency is going
to make a determination this year as to whether or not we feel
it is appropriate to establish an MCL, maximum contaminant
level for perchlorate. That is referred to as a regulatory
determination under the Safe Drinking Water Act, and in 2010,
that decision will be made.
Mr. McNerney. Then your opinion is not to be given this
morning?
Mr. Jones. I am sorry. We are trying at EPA to coordinate
better across our offices. I am actually not in the office that
manages the Safe Drinking Water Act. I am in the office that
manages the endocrine disruptor screening program, so although
I am familiar with where the office of water is with respect to
that determination. Because I am not intimately familiar with
the facts around perchlorate, I think it would not be wise for
me to offer an opinion on that.
Mr. McNerney. OK, thank you. Dr. Solomon, do you think the
Safe Drinking Water Act worked effectively in regulating
hazardous chemicals in drinking water? And if not--and I
suspect that you are going to say that you don't--do you have
specific recommendations?
Dr. Solomon. The Safe Drinking Water Act as amended in 1996
required the creation of these various candidate contaminant
lists. We are now on the third iteration, and in each case, EPA
has gone through an extensive exercise to create the list and
then has actually not taken any action to regulate any of the
chemicals on these priority lists and has simply moved on to
create another priority list.
And so I am very much hoping that, you know, EPA will take
action and start setting some regulatory standards on these
chemicals. There is now well over 100 chemicals that have been
identified as priorities, and, you know, on the CCL 3 as
potential priorities. And a number of those really do need to
move forward.
Mr. McNerney. So in other words, you don't think they have
been that effective so far and could be more effective?
Dr. Solomon. Yes, EPA does have the authority to, you know,
take the action that it needs to, but it is, you know, since it
just needs to make a determination, it can, you know, on each
of the previous CCL lists, the determination has just been that
various chemicals did not need to be regulated.
So it is very easy for the agency to avoid taking any
action if it doesn't want to take action.
Mr. McNerney. Thank you. Dr. Borgert, good morning.
Mr. Borgert. Good morning.
Mr. McNerney. You know I was a scientist or a mathematician
in a past life. So I appreciate your comments about having
repeatable science; however, I think the people in Morgan Hill
would say there should have been precautions taken before they
put the perchlorate in the ground even though they didn't know
it was an endocrine disruptor and a cancer-causing agent at
that time.
So my point is that when human health is at risk, when
human health is on the line, we shouldn't wait for permanent or
absolute certainty. Absolute certainty in science is very, very
hard to come by, and if we wait for absolute certainty, we are
going to be dying from all kinds of problems.
So I think we need to put some sort of risk into the
consideration in making these kinds of decisions even though
absolute certainty has not been achieved. Do you have a
comment?
Mr. Borgert. Yes, I do. I couldn't agree with you more that
we need to be precautionary when we actually know what the
risks are. But let me give you an example of what can happen
when you think you know what the risks are and, in fact, you
don't fully appreciate them.
Now, I think you gave us an example with perchlorate in the
drinking water. And certainly I am not an engineer, but if
there were good and valid methods, engineering methods for
protecting against that, maybe those precautions should have
been taken.
But on the human health side, I want you to consider the
example of dietary fat. There was a day when we thought fat
was, you know, across the board a bad thing, and we tried to
eliminate, many of us did, tried to eliminate fats from our
diet.
Today many of us take fish oil, which is a fat. With a
little more reliable research and a little more understanding,
we recognize that what we thought was a precautionary approach
may actually have been harmful. It is not good to remove all
the fat from your diet. Some are very beneficial.
So sometimes you act with very good intentions to do what
you believe is precautionary, and because you have rushed to
judgment, you actually have done the opposite of what you
intended.
Mr. McNerney. Well, I don't know that we need to rush to
judgment, Dr. Borgert, but I think we need to be precautionary
when there is evidence, even association, that there is risk. I
think we need to be precautionary and take steps ahead of time
before the city of Morgan Hill has a $100 million cleanup on
their hands and no company left again to do the cleanup.
And I think across the board when there is evidence and
associations of risk, we need to act accordingly. Mr. Chairman,
I don't have another 3 minutes of voice, so I am going to refer
back to you.
Mr. Markey. Thank you. William Shakespeare said that
brevity is the soul of wit, and I think you got right at the
heart of the matter, and we thank you for that.
The gentleman from Texas, Mr. Green.
Mr. Green. Thank you, Mr. Chairman. I would like to ask
unanimous consent to place a statement in the record.
Mr. Markey. Without objection, it will be so ordered.
[The prepared statement of Mr. Green
follows:]*************** COMMITTEE INSERT ***************
Mr. Green. Dr. Solomon, this is for you and I would enjoy
hearing other on the panel that has an opinion. Some have
suggested that the present endocrine disruptors in drinking
water isn't really that alarming because the levels at which
they are detected are so low.
First, are there adverse health effects associated with
low-dose exposure to these chemicals?
Dr. Solomon. There are a few reasons why I am concerned
about these chemicals in drinking water. One was actually
raised by the chairman and other members of the committee,
which is the fact that wildlife populations exposed to some of
these source waters in which various low doses of endocrine
disruptors are present are showing abnormalities such as the
intersex fish seen in the Potomac River and in many other
rivers and streams across the United States.
I am also concerned because there are quite persuasive data
showing that multiple chemicals can actually act together to
create greater effects as mixtures or at least additive
effects. And there are complex mixtures of various endocrine
disruptors. As I mentioned in my testimony, up to more than 30
chemicals in a single water sample have been reported by the
USGS.
And in addition, I am concerned because of the remarkable
sensitivity of hormone systems, not so much in the adult,
where, as Dr. Borgert mentioned, there are some ability to sort
of almost, you know, respond or buffer some alterations in
hormones that occur, you know, transiently or even longer term,
but in fetuses and infants where short-term alterations in
hormones can actually have long-term effects on normal
development. And so it is really those populations that I am
most concerned about.
Mr. Green. My second question, and again open it to the
panel. What you are saying then is when someone is exposed to
low doses from several different potential endocrine disruptors
has a problem, so you answered the second question. Dr. Borgert
or anyone else have a response to that question?
Mr. Borgert. Yes, I do. I think it is on point and raises
an issue of one of the things that Dr. Solomon said. Mixtures
are definitely an important area of research. I have devoted a
large portion of my career to that, have several publications
on it. About a year ago in December, I addressed the National
Research Council on the issue of mixtures of pharmaceuticals in
the water supply.
And here again my message was similar. We need to rely on
demonstrated scientific methods, and it hasn't been
demonstrated by any stretch of the imagination that these very
low levels of chemicals with low potency actually have
synergistic effects or even additive effects at the levels in
the environment at which we encounter them.
At higher levels, perhaps, but one of the rules of mixtures
is what happens at one level and one ratio of components is not
predictive of what happens at other levels and other ratios of
those components. So we can't make those extrapolations. And
one of the things we know is it is incorrect to do that, so it
is best not to do that.
Mr. Green. Obviously we have a difference here from both
our doctors.
Ms. Birnbaum. I would like to comment on that, if possible.
Mr. Green. In fact, let me actually get you a question
though. Obviously it has been suggested that although
endocrine-disrupting affects animals, it has been demonstrated
humans are better able to deal with low doses of chemicals
without suffering adverse effects. Can you talk about the low
dose issue earlier? And along with that, are humans any
different from other animals that may consume drinking water?
Ms. Birnbaum. Nature is inherently conservative, and the
endocrine system is well conserved across from fish to
amphibians to all the way up to mammals, and that includes us.
There are numerous effects of endocrine effects in wildlife,
not only fish, but for example amphibians, bird, and mammalian
wildlife as well as beginning, we are seeing effects in people.
I have to say that there is a great deal of data on
mixtures at low environmentally-relevant concentrations for a
number of different endocrine kinds of effects, effects on
estrogens, effects on the androgen system, effects on the
thyroid system, which demonstrate in animal models that
additivity--at low concentrations again I am talking about. I
am not talking about high levels. I am talking about low
levels--appear to act in an additive fashion. So I think we
have a real issue when we look at one chemical at a time
instead of looking at multiple chemicals at low levels in the
body at a time.
Mr. Green. And again is there research being done now on
the low level for multiple exposure?
Ms. Birnbaum. Yes, there is. We are funding a great deal of
research in that area, and I should mention that I have
published extensively myself in this area of mixtures, and it
is very important that you work at low levels because if you go
to very high levels, I agree with Dr. Borgert that different
things can happen. But you need to work at low levels.
And we are funding work. For example, we are actually
funding some studies right now at the Environmental Protection
Agency's Office of Research and Development to look at the
interaction of multiple phthalates which have been shown to
interact additively in blocking androgen action.
Mr. Green. Thank you, Mr. Chairman. Any other response from
anyone on the panel?
Mr. Borgert. Just one. I think we are using qualitative
terms like low doses, and I think we have probably a difference
of viewpoint on what is low. And I don't think that it has been
demonstrated that the levels of these chemicals to which humans
are exposed are acting in an additive fashion. That is an
unresolved question, and again my caution I think have stated.
Mr. Green. Well, and again no matter what level we make the
low dosage, the concern and the question was low dosage of a
multiple number of endocrine disruptors in low dosage because
we may not have a high dosage. But because of our lifestyle, we
have multiple opportunities to have that.
So thank you, Mr. Chairman. I know I have run out of time.
Mr. Markey. Gentleman's time has expired. Chair recognizes
the gentleman from Louisiana, Mr. Scalise.
Mr. Scalise. Thank you, Mr. Chairman. A couple of
questions. First for Dr. Birnbaum. I think you had spoken or
there was something written about your agency a few months ago
that there were a number of research grants to university
professors and others as part of the stimulus bill that, I
think, totaled somewhere around $30 million. Primarily they
were supposed to be used to conduct additional research on BPA.
Can you tell me what processing criteria you used through the
agency for the awarding of the grants and then also if you can
give us an idea of how many new jobs were created by that
stimulus money?
Ms. Birnbaum. The stimulus money, we funded somewhere in
the neighborhood of $10 to $15 million worth of research on
BPA. The process that was used by NIH to give the stimulus
money as part of our usual very, very extensive extramural peer
review process. So some of the BPA work was funded under a
special program coming from funding partly directly from our
agency and partly from the office of the director, which is
called the Challenge Program and the GO Program. And these were
for high-priority needs to address health effects in the
Nation.
So that there was a request made for innovative research to
address projects. The GO projects, known as the Grand
Opportunity, were for projects. And in our agency, one of the
topics that we put out was for understanding and expanding our
knowledge base on BPA.
We have funded 11 specific grants that are looking at the
effects of BPA. These are effects looking at cancer, both
prostate and mammary, but looking at the immune system, looking
at developmental neurological effects, looking at
cardiovascular effects and a variety of animal models.
In addition, BPA has been in our sites for a number of
years and in our regular extramurally-funded and peer-reviewed
grants programs. We are looking at effects of BPA in human
populations as well, and as I mentioned, one of the first
results from that was recently published in the peer review
literature, clearly needs to be repeated, but demonstrates an
association between the mother's exposure of BPA during her
first trimester and neural behavioral effects in her children
of 2 years of age.
We are also funding ongoing studies with FDA to look at
long-term effects in both rats and mice to BPA. We are also
funding some studies in our intramural program in collaboration
with outside investigators.
Mr. Scalise. I apologize for pulling back because I am
limited on my time.
Ms. Birnbaum. I was going to mention the----
Mr. Scalise. But I did want to ask--and I don't know if all
those grants you were talking about, how much was stimulus
money versus just regular department money.
Ms. Birnbaum. About $10 to $15 million.
Mr. Scalise. So all that $10 to $15 million of stimulus
money which was supposedly brought forward to create jobs, how
many jobs were created with the $10 to $15 million of stimulus
money?
Ms. Birnbaum. Specifically with the BPA, I can tell you
with the approximately $168 million of funding that NIEHS was
allotted to send to the extramural community with the stimulus
money, that that has funded about 300 different grants. And we
know that new jobs--I am not talking about continuation of
jobs--but new jobs was about 436 new jobs.
Mr. Scalise. OK, and if you can get us the information on
those new jobs.
Ms. Birnbaum. We can get you more specifics.
Mr. Scalise. And specifically with the stimulus money
portion, not your regular department.
Ms. Birnbaum. I am just talking about--the 430 plus jobs--
--
Mr. Scalise. Right, but we were told during the passage of
the stimulus bill that there would be transparency in actually
tracking the jobs created with that money, not with other
money, with the stimulus money. I am just asking you for that
transparency if you could get that to me.
Ms. Birnbaum. I would be happy to provide it.
Mr. Scalise. Thanks.
Ms. Birnbaum. I believe that is available----
Mr. Scalise. Next question because I only have a minute
left. During your written statement, you had mentioned that you
try to ensure that focus on doing high-quality science or
ensuring that its work adheres to the basic tenets of good
objective science. Your statement didn't mention that. What I
am asking you is would you give us a pledge that when you are
doing this work that you would only adhere to the basic tenets
of good objective science since that wasn't in your testimony?
Ms. Birnbaum. Peer-reviewed science stands the nature of
time, and our studies are undergoing extensive peer review both
in the funding of studies, in the conduct of studies, and in
the actual publication of studies. The NTP studies, which are
funded are considered the gold standard for traditional
toxicity kinds of testing. I think it is very important to
understand that science is moving on, and the best studies of
20 and 30 years ago may not be the best studies.
Mr. Scalise. But would you base the decisions on the best
science?
Ms. Birnbaum. My studies are always based on the best study
of all the peer-reviewed science.
Mr. Scalise. Thank you, and I yield back.
Mr. Markey. Gentleman's time has expired. The chair
recognizes the gentleman from Washington State, Mr. Inslee.
Mr. Inslee. Thank you. I am just looking at an article from
the Seattle Times. I am from Seattle. In 2007, it talked about
fish, English sole, carrying something in their bodies not
supposed to be there, a protein usually found only in female
fish with developed eggs. And we found these chemicals, and the
article quotes sources of suggestion that birth control pills,
plastic bottles, detergent, makeup, and more chemicals from
various sources may be associated with that protein.
Dr. Birbaum, first of all, I don't understand this biology
as well as I should. Is that protein that this article is
referencing the chemical itself, or it is an expression or
result of the presence of a chemical that causes that protein
to be there where it shouldn't be?
Ms. Birnbaum. You are talking about fatelegenin, which is a
protein that is normally only present in female fish, and if
the females are exposed to endocrine-disrupting chemicals, then
in fact the males begin to produce fatelegenin. So just like in
the Potomac River and parts of Puget Sound and many other
waterways in our Nation, we are finding male fish that have
eggs in their testes, and they are producing fatelegenin.
Mr. Inslee. And what is that mechanism? I don't understand.
You said if the female is--you mean the mother of the male?
Ms. Birnbaum. No, these are the fish, female fish produce
fatelegenin, which is a protein that actually goes into making
the egg. It goes into the egg and provides nutrition for the
baby, you know, the developing embryonic fish. Males, when
exposed to environmental endocrine disruption, they begin
producing fatelegenin, and they also begin making eggs.
Mr. Inslee. They pick it up from the water?
Ms. Birnbaum. No, they get the endocrine-disrupting
chemicals from the water or food particles in the water. But
then they make--that is their response to the disruption.
Mr. Inslee. So is there a question about whether that is in
fact occurring in our waters or not? Is that subtle science?
Ms. Birnbaum. I think there is extensive evidence for the
presence of male fish producing female responses.
Mr. Inslee. And is there any other hypothesis been
suggested that it is other than endocrine disruptors that are
causing this?
Ms. Birnbaum. I don't know of any.
Mr. Inslee. Does anybody in the panel have any other
hypothesis as to what is causing this other than endocrine
disruptors?
Mr. Borgert. I think it is important to understand what we
mean when we say endocrine disruptors, and Dr. Birnbaum
mentioned this, I believe, in her answer. But we don't know
exactly which chemicals might be doing that, for instance, and
there have been instances where we again rush to judgment on
similar findings of fatelegenin in male fish in the U.K. And
based on those preliminary suspicions, a number of products
were taken off the market because they were suspected endocrine
disruptors.
Turns out the most likely culprit was simply female
hormones from human beings, and the water treatment plants were
not up to snuff. They were not state-of-the-art, and they were
not properly breaking down those compounds. Some of the
compounds also may have been birth control pills.
So it is important to recognize that when you see an
effect, that doesn't automatically tell you which chemicals
might be involved. And so I think that is one of the critical
questions.
Mr. Inslee. So is it----
Mr. Borgert. Brings up another--well, I just wanted to make
a quick point is that our analytical techniques are now
thousands if not ten thousand-fold better than they were a
decade or so ago. So what would appear to have been a perfectly
clean water sample a decade ago now looks very contaminated,
and that is simply because our analytical techniques are so
much better.
Mr. Inslee. Well, I guess----
Mr. Borgert. Finding what the cause is is not always easy.
Mr. Inslee. What I am trying to get at is it relatively
clear that the presence of maybe not specifically identified
but generally defined as endocrine disruptors in our waterways
are causing the presence of proteins in male fish that are not
normally there. When I say normally meaning absent an
industrial base that pollutes our water. Is that fairly well
established, Dr. Birnbaum? I will just ask your opinion about
that.
Ms. Birnbaum. Absolutely.
Mr. Inslee. OK, Mr. Jones?
Mr. Jones. Yes, I would agree with that.
Mr. Inslee. Dr. Solomon?
Dr. Solomon. Yes, I would agree with that.
Mr. Inslee. And Dr. Borgert?
Mr. Borgert. Yes, I would agree that it can happen. I would
have to disagree though that that is always the case. We don't
know of all the factors that might affect that, and in some
instances, their habitat alterations for other effects that
cause other effects that may lead to the same thing. I don't
think we have unraveled the story completely.
Mr. Inslee. But we don't think it is sunspots, right? I
mean we would agree we don't think there are sunspots? That is
a rhetorical question.
Mr. Borgert. I haven't heard sunspots.
Mr. Inslee. Well, we have heard sunspots blamed for a lot
of significant global activity. We just wonder if this is
another one of them. Mr. Jones, can you give me sort of a lay
answer that I can convey to my constituents on what percentage
of chemicals that in the realm of possibility could be
considered endocrine disruptors will be adequately tested by X
date that we can tell our constituents that will have been
receiving an appropriate level of the screening to determine
whether or not they present a human health risk? Could you give
me percentages by certain dates on the current track that we
are on?
Mr. Jones. The current track that we are on will take many
years to tell you what that percentage is. The universe of
chemicals in front of us include a thousand pesticides, and
people throw around the number of 80,000 industrial chemicals.
It is probably actually more in the range of 40,000. So we are
talking about tens of thousands of compounds. Under current
techniques, it will take many years to evaluate them all. We
are working very hard with our colleagues in NAHS and some
other agencies within the executive branch to develop
alternative methods that will allow us to test thousands of
chemicals in very short periods of time.
That work, however, is not quite ready up to the task that
we are seeking and that you are asking for. So I am hopeful
that within the next 5 years those kinds of methods are
available which will allow us to test thousands of chemicals in
a matter of weeks as opposed to hundreds of chemicals in a
matter of years.
But that is still developmental. Under the existing
framework that we have, it takes quite a while to even do the
screening test, and we are talking about a universe of, as I
said, upwards of 40,000 chemicals that you would need to screen
to be able to tell you which percentage----
Mr. Inslee. Very quickly. Probably be a decade before we
have 50 percent of these tests----
Mr. Jones. Absolutely.
Mr. Inslee. --concluded? Thank you.
Mr. Markey. The gentleman's time has expired. And just for
clarification, Mr. Jones, earlier you told me that BPA was not
on the list of chemicals that EPA was using to examine the
purposes of setting drinking water standards. But I had asked
you why EPA didn't put BPA onto its chemicals of concerns
action plan despite the data and the administrator's statements
regarding her concerns about the chemical. Can you clarify?
Mr. Jones. Yes, and thank you for asking that. Going back
to the CCL list part of my answer.
Mr. Markey. What does CCL mean?
Mr. Jones. The chemical contaminant list. That is the list
of potential drinking water contaminants for regulation that
was released last summer. It is not on that list; however, the
work that is going on right now at the Food and Drug
Administration, which we are working with them on, could
ultimately lead to a different conclusion. So that work will
inform future CCL lists.
As it relates to BPA as an industrial chemical as opposed
to a drinking water contaminant, the agency is planning on in
the not-too-distant future--and the administrator has spoken to
this, and I think she actually testified yesterday at the
appropriations hearing. That action plan is with the Office of
Management and Budget right now going through interagency
review, and we are hopeful that it will be publicly released in
the very near future. So it could be on that last. Yes, it will
be on that list.
Mr. Markey. OK, it will be on that list. OK, that is
important. OK, so we thank you all for coming here today. It is
a very important hearing, and we thank anyone who has been
watching this hearing on C-SPAN today. The endocrine system for
human beings is really just our computer system. It is just a
computer, and like a computer, if someone hacks in to a
computer and drops in a new virus, it can cause a tremendous
disruption to a computer.
And there is one thing no one wants in America or in the
world is for someone to hack in to their computer, for someone
to add in a virus that can begin to disrupt it. No matter how
small that virus might be, it is a big change in your
relationship with the computer.
Well, the endocrine system is the computer system, and that
is why we are so concerned about it, that the more that the
water, other avenues, that are used in order to disrupt the
endocrine system, the computer system for human beings, you
start to get these very significant or even minor changes in
the body. And it can have very significant changes in the way
in which people live.
And so that is why it is so important, and since we are
seeing significant changes over the last 30 or 40 years,
whether it be, you know, autism or you go down the whole list,
we are wondering what is happening? Why are we seeing so much
larger identification of these problems in human beings?
And so, you know, scientists are like the detectives. They
look around. They see what could have hacked in to the human
being. What is different? What is going into human beings that
weren't going into human beings before especially as they
affect children because that is when the system is most
vulnerable?
That is when a computer is most vulnerable, when it is
brand new. You know it hasn't quite developed all of its
defenses yet. You haven't added in all of the software packages
that can defend, and so it is much more vulnerable to changes,
oK.
So that is why we are so concerned about it, and that is
why I am concerned about BPA as it affects especially things
that are close to children. That is what my legislation would
be most concerned with, the kinds of things that children would
be putting into their bodies because obviously that would have
a more profound effect on the computer system of the body.
So we thank you so much for your testimony here today, and
in the weeks and months ahead, we are going to be pursuing this
very aggressively. And I want to make sure that the right
things are done in order to protect against the things which we
think have a higher likelihood of having an impact especially
upon children in our country.
So we thank you all for your testimony, and I tell you what
I am going to do. I am going to give each of you 1 minute to
summarize what it is that you want us to remember about your
testimony and would ask you to put it in as simple a language
as is possible. And try to use as many monosyllabic words as
you can in order to make it possible for us to in 1 minute
understand what you are trying to tell us. We will go in
reverse order of the opening statements, and Dr. Borgert--I am
sorry as you are, I am sure, that Humphrey Bogart ever lived.
That your name is constantly mispronounced. But we thank you,
sir, for being here. Whenever you are ready, please begin. One
minute.
Mr. Borgert. Well, thank you for that opportunity, sir. I
would just leave you with one admonition, and that is to make
sure that the information we gather is based on repeatable
science, that is based on reliable science, that is based on
relevant science, and that the data be evaluated for themselves
for the relevance and reliability and repeatability and not
merely over what can be suggested or hypothesized from that
data, but what the data actually show. And I think that is very
important in any decision-making process that will involve
regulation because we risk actually imperiling ourselves rather
than protecting ourselves with faulty information.
Mr. Markey. OK, thank you. Dr. Solomon.
Dr. Solomon. Yes, as was the case around the health effects
of tobacco, there were many, many years through questions being
raised and, you know, claims that the science was not totally
clear yet. And it is always easy to do that kind of thing
because science is never 100 percent crystal clear. But we do
need to act based on the information we have, and major
medicine societies such as the Endocrine Society and the
American Medical Association have concluded, I actually quote
``the evidence for adverse reproductive outcomes in fertility,
cancer, malformations, from exposure to endocrine-disrupting
chemicals is strong.''
So we need to look at the conclusions of these important
medical organizations and move to take action to protect human
health. Thank you.
Mr. Markey. Thank you, Dr. Solomon. Mr. Jones.
Mr. Jones. EPA is very worried about endocrine-disrupting
chemicals not only in drinking water but in other media, and we
are moving very aggressively in our testing program. Although,
we are as frustrated as the committee is and many others of the
public about how long it took to develop a testing schematic to
evaluate chemicals for endocrine disruption.
We have done that now, and that testing schematic is ready
to be deployed. And we will be deploying it aggressively I
think as evidenced by the first orders that have gone out in
the last three months and our commitment here today to begin
using the discretionary authority in the Safe Drinking Water
Act to begin screening chemical contaminants in drinking water
in the very near future.
Mr. Markey. Thank you, Mr. Jones. Dr. Birnbaum.
Ms. Birnbaum. Fish, frogs, birds, and mammalian wildlife
are our canaries in the coalmine when we talk about endocrine
disruption. The doses that are causing these effects when you
look in the animals are many times comparable to the effects
that we actually are measuring in humans, and we are finding
that essentially the entire American population has these
chemicals in their body.
These chemicals are not associated with one health effect.
They are associated with a multitude of health effects because
what the hormones do is integrate everything in our body. They
control development, and they control our normal way of life.
Thank you.
Mr. Markey. Thank you, Dr. Birnbaum, very much. So we thank
all of you for being here. I think the lessons that were
learned is that in order to ensure that drinking water is safe
that we must make sure that the endocrine disruptor screening
program robustly and aggressively tests chemicals to see which
ones cause endocrine-disrupting health effects and that the
screening program adapts its tests to take advantage of new
scientific advances and that we move in a way that does so in a
very rapid process because the EPA additionally must move
forward to regulate known endocrine disruptors without
conducting redundant and duplicative tests.
When we have enough information, we are going to have to
move because clearly there are families all across the country
very concerned about the impacts, especially upon children. And
as soon as we reach that level where we have enough evidence, I
just think that we should err on the side of caution because
some very significant things are happening amongst children in
our country that we have not seen in previous generations. And
we know it is related to this endocrine-disruptor issue.
So we thank you all so much. We are going to be working
very closely with you in the months ahead. This hearing is
adjourned.
[Whereupon, at 11:30 a.m., the Subcommittee was adjourned.]
[Material submitted for inclusion in the record follows:]