[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

                              ----------                              
                                                                   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:]

                                 
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