[Senate Hearing 111-1222]
[From the U.S. Government Publishing Office]


                                                       S. Hrg. 111-1222

                  CURRENT SCIENCE ON PUBLIC EXPOSURES 
                           TO TOXIC CHEMICALS

=======================================================================

                                HEARING

                               BEFORE THE

                   SUBCOMMITTEE ON SUPERFUND, TOXICS
                        AND ENVIRONMENTAL HEALTH

                                 of the

                              COMMITTEE ON
                      ENVIRONMENT AND PUBLIC WORKS
                          UNITED STATES SENATE

                     ONE HUNDRED ELEVENTH CONGRESS

                             SECOND SESSION

                               __________

                            FEBRUARY 4, 2010

                               __________

  Printed for the use of the Committee on Environment and Public Works
  
  
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              COMMITTEE ON ENVIRONMENT AND PUBLIC WORKS

                     ONE HUNDRED ELEVENTH CONGRESS
                             SECOND SESSION

                  BARBARA BOXER, California, Chairman
MAX BAUCUS, Montana                  JAMES M. INHOFE, Oklahoma
THOMAS R. CARPER, Delaware           GEORGE V. VOINOVICH, Ohio
FRANK R. LAUTENBERG, New Jersey      DAVID VITTER, Louisiana
BENJAMIN L. CARDIN, Maryland         JOHN BARRASSO, Wyoming
BERNARD SANDERS, Vermont             MIKE CRAPO, Idaho
AMY KLOBUCHAR, Minnesota             CHRISTOPHER S. BOND, Missouri
SHELDON WHITEHOUSE, Rhode Island     LAMAR ALEXANDER, Tennessee
TOM UDALL, New Mexico
JEFF MERKLEY, Oregon
KIRSTEN GILLIBRAND, New York
ARLEN SPECTER, Pennsylvania

                    Bettina Poirier, Staff Director
                 Ruth Van Mark, Minority Staff Director
                              
                              ----------                              

       Subcommittee on Superfund, Toxics and Environmental Health

               FRANK R. LAUTENBERG, New Jersey, Chairman
MAX BAUCUS, Montana                  JAMES M. INHOFE, Oklahoma
AMY KLOBUCHAR, Minnesota             MIKE CRAPO, Idaho
SHELDON WHITEHOUSE, Rhode Island     CHRISTOPHER S. BOND, Missouri
KIRSTEN GILLIBAND, New York
ARLEN SPECTER, Pennsylvania
BARBARA BOXER, California (ex 
    officio)
                            C O N T E N T S

                              ----------                              
                                                                   Page

                            FEBRUARY 4, 2010
                           OPENING STATEMENTS

Lautenberg, Hon. Frank R., U.S. Senator from the State of New 
  Jersey.........................................................     1
Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma...     2
Udall, Hon. Tom, U.S. Senator from the State of New Mexico.......     4
Vitter, Hon. David, U.S. Senator from the State of Louisiana.....     5
Cardin, Hon. Benjamin L., U.S. Senator from the State of 
  Maryland, prepared statement...................................   186
Gillibrand, Hon. Kirsten, U.S. Senator from the State of New 
  York, prepared statement.......................................   187

                               WITNESSES

Owens, Stephen, Assistant Administrator, Office of Prevention, 
  Pesticides and Toxic Substances, U.S. Environmental Protection 
  Agency.........................................................    14
    Prepared statement...........................................    17
Falk, Henry, M.D., MPH, Acting Director, National Center for 
  Environmental Health, Centers for Disease Control and 
  Prevention and Agency for Toxic Substances and Disease 
  Registry, U.S. Department of Health and Human Services.........    24
    Prepared statement...........................................    26
    Responses to additional questions from:
        Senator Klobuchar........................................    46
        Senator Inhofe and Senator Vitter........................    50
Stephenson, John, Director, National Resources and Environment, 
  U.S. Government Accountability Office..........................    51
    Prepared statement...........................................    53
    Responses to additional questions from Senator Inhofe and 
      Senator Vitter.............................................    66
Birnbaum, Linda, Ph.D., DABT, ATS, Director, National Institute 
  of Environmental Health Sciences, National Institutes of 
  Health, and Director, National Toxicology Program, U.S. 
  Department of Health and Human Services........................    68
    Prepared statement...........................................    70
    Responses to additional questions from:
        Senator Sanders..........................................    76
        Senator Klobuchar........................................    77
        Senator Inhofe and Senator Vitter........................    80
Gray, Molly Jones, participant in a biomonitoring study..........    89
    Prepared statement...........................................    92
McKay, Charles, M.D., FACMT, FACEP, ABIM, Division of Toxicology, 
  Department of Emergency Medicine, Hartford Hospital, Hartford, 
  Connecticut....................................................    94
    Prepared statement...........................................    96
    Response to an additional question from Senator Klobuchar....   113
Woodruff, Tracey J., Ph.D., MPH, Associate Professor and 
  Director, Program on Reproductive Health and the Environment, 
  Department of Obstetrics, Gynecology, and Reproductive 
  Sciences, University of California, San Francisco..............   115
    Prepared statement...........................................   118
    Responses to additional questions from Senator Inhofe and 
      Senator Vitter.............................................   123
Cook, Kenneth A., President, Environmental Working Group.........   133
    Prepared statement...........................................   136
    Response to an additional question from Senator Klobuchar....   175
    Responses to additional questions from Senator Inhofe and 
      Senator Vitter.............................................   176

                          ADDITIONAL MATERIAL

Statement by Collin P. O'Mara, Secretary, Natural Resources and 
  Environmental Control, State of Delaware.......................   189

 
         CURRENT SCIENCE ON PUBLIC EXPOSURES TO TOXIC CHEMICALS

                              ----------                              


                       THURSDAY, FEBRUARY 4, 2010

                               U.S. Senate,
         Committee on Environment and Public Works,
                         Subcommittee on Superfund, Toxics 
                                  and Environmental Health,
                                                    Washington, DC.
    The subcommittee met, pursuant to notice, at 10 a.m. in 
room 406, Dirksen Senate Office Building, Hon. Frank R. 
Lautenberg (chairman of the subcommittee) presiding.
    Present: Senators Lautenberg, Inhofe, Udall, Vitter, Boxer, 
Klobuchar, and Whitehouse.

        OPENING STATEMENT OF HON. FRANK R. LAUTENBERG, 
           U.S. SENATOR FROM THE STATE OF NEW JERSEY

    Senator Lautenberg. Welcome to our witnesses. We have a 
major matter of interest because we are really going to be 
working very hard to make sure that we are doing the best that 
we can to protect the lives and well-being of our human 
population. And I thank everyone for being here as we focus on 
protecting the health of our families by updating our chemical 
safety laws.
    Now there is no question that chemicals are essential to 
our modern living. They are used in household cleaners to kill 
germs, they are used in medical equipment that saves lives, 
they even help fight global warming by creating insulation for 
homes, better components for wind turbines, and additives to 
make fuels cleaner.
    But when we use these products the chemicals in them can 
end up in our bodies. So, in essence the American public has 
become a living, breathing repository for chemical substances. 
And when the chemicals used in flame retardants, plastics or 
rocket fuel show up in our children's bodies we have a 
potentially dangerous situation.
    We can trace this problem back to current law that covers 
the safety of chemicals. That law, the Toxic Substances Control 
Act, or TSCA as it is known, fails to give EPA the tools it 
needs to protect against unsafe chemicals. In fact the 
Government Accountability Office has identified our current law 
as a high risk area of law.
    In nearly 35 years TSCA has allowed EPA to test only 200 of 
the more than 80,000 chemicals in the products that we use 
every day. What is more, EPA has been able to ban only 5 
substances on EPA's inventory of chemicals on the market.
    With EPA unable to require adequate testing our children 
have become the test subjects. And we are seeing the results in 
a dramatic increase in childhood cancers, birth defects and 
hormonal problems across the population. Studies have found 
that as much as 5 percent of cancers, 5 percent of cancers, 10 
percent of neural behavioral disorders, and 30 percent of 
asthma cases in children are associated with hazardous 
chemicals. Our children should not be used as guinea pigs. So, 
it is time to update the law and protect our children.
    Led by a distinguished leader in Lisa Jackson--she is from 
New Jersey, I quickly mention--and Assistant Administrator 
Steve Owens, he is here with us today, the Environmental 
Protection Agency has taken steps to try to reduce the risks 
from chemicals. But they cannot protect our children with one 
hand tied behind their back.
    And that is why I will soon introduce a bill that will 
overhaul our Nation's chemical laws. My Safe Chemicals Bill 
will have a simple goal: force chemical makers to prove that 
their products are safe before they end up in a store, in our 
homes, or in our bodies. We already regulate pesticides and 
pharmaceuticals this way, and it is just common sense that we 
do the same for chemicals that are used in everyday consumer 
products.
    Everyone from the chemical manufacturers to businesses that 
use chemicals in their products to environmental, labor and 
health groups has called for a reform of our chemical laws. We 
cannot waste this opportunity.
    I will be reaching out in the coming weeks to our 
colleagues, Democrats and Republicans alike, to support my Safe 
Chemicals Bill. It is a problem that affects all of us, and we 
should all be committed to working on this solution.
    There is nothing more important in our lives than the 
health and well-being of our families, our children. There is a 
lot of susceptibility out there, and we are going to find out 
exactly what kind there is and what we can do to fight against 
it.
    And I am pleased to have our colleague, the Ranking Member 
of the committee, Senator Inhofe.

          OPENING STATEMENT OF HON. JAMES M. INHOFE, 
            U.S. SENATOR FROM THE STATE OF OKLAHOMA

    Senator Inhofe. Thank you, my good friend Senator 
Lautenberg, for holding the hearing on the state of the science 
and human exposure of chemicals. We have talked about this for 
many years, and it is my understanding that this is the first 
of a series of hearings.
    I am glad we are doing this. We have had nothing but global 
warming hearings for the last 2 years, and there are other 
issues that we need to get to. I say to my friend Steve Owens, 
we want to build some roads and some other things. So, I am 
glad that today we will hear the perspectives on scientific 
approaches for evaluating human exposure to chemicals.
    In particular, I am interested in the discussion relating 
to biomonitoring, one of the scientific techniques used for 
assessing human exposure for natural and synthetic compounds in 
the environment. I believe that biomonitoring can be a useful 
tool in assessing the human chemical exposures, but it has its 
limits as it provides only information on exposure. It does not 
provide dosed information.
    Simply put, the presence of a substance in the body at any 
level cannot be interpreted as being adverse. We go through 
this all the time. People say, oh, we cannot have any arsenic 
in water. And yet there is always arsenic in water. Everybody 
knows that. But the level is what we are concerned with. And 
you cannot start legislating these levels where the science is 
not there in terms of causing problems in human health.
    I know in my State of Oklahoma we have so many people, 
Senator Lautenberg, in small communities, that we send those 
mandates out and we give them targets, I do not know if it is 
wastewater treatment or anything else, but it costs millions of 
dollars. You do not have a lot of the poor communities in New 
Jersey that we do in Oklahoma. And they just cannot do this. 
So, to me this panel is very important.
    The most important thing in dealing with this is that we do 
it on sound science. And I just cannot tell you, we went 
through this thing with the IPCC, with the United Nations, for 
10 years. I can remember 10 years ago, when I was the Chairman 
of this committee, when Republicans were the majority, and we 
looked at the false science. I can remember 4 years ago, 
Senator Lautenberg, I made a speech on the floor for about an 
hour, talking about the scientists who had come to me and said 
hey, this is cooked science.
    Then 4 years later, right before Copenhagen, we find out in 
fact that is the case. ClimateGate came right before that and 
what happened yesterday and the day before, GlacierGate, 
AmazonGate, and all the rest of these things. What I am saying 
is it was cooked science, and this thing that we said some 4 
years ago is exactly what happened.
    So, I would hope that on this that we are very careful to 
make sure that we use sound science and do not overreact to 
something. I am glad that we have the witnesses that we have 
today, and I am looking forward to hearing their comments about 
what they are going to do, what their opinion is, in terms of 
the health effect that is out there and any health to our 
people.
    That is what we are supposed to be doing up here, and that 
is what we are going to do, Senator Lautenberg.
    [The prepared statement of Senator Inhofe follows:]

                  Statement of Hon. James M. Inhofe, 
                U.S. Senator from the State of Oklahoma

    Thank you, Chairman Lautenberg, for holding this hearing on 
the state of the science of human exposures to chemicals. My 
understanding is that this is the first in a series of hearings 
leading up to a legislative debate on revision of the Toxic 
Substances Control Act (TSCA). I welcome the opportunity to 
discuss the strengths and weaknesses of the law and the science 
surrounding it.
    Today we will hear perspectives on scientific approaches 
for evaluating human exposures to chemicals. In particular I am 
interested in the discussion related to biomonitoring--one of 
the scientific techniques used for assessing human exposures to 
natural and synthetic compounds in the environment.
    I believe that biomonitoring can be a useful tool in 
assessing human chemical exposures. But biomonitoring has its 
limits as it provides only information on exposure; it does not 
provide dose information. Simply put the presence of a 
substance in the body at any level cannot be interpreted to 
mean that adverse effects will occur.
    I hope the witnesses here today remain objective in their 
discussions of biomonitoring and avoid the temptation to rely 
on detection as a surrogate for risk. Misapplying biomonitoring 
data only serves to scare the public and in some cases advance 
political agendas. By invoking notions of ``body burden'' and 
``chemical trespass'' people who do not understand the 
limitations of biomonitoring are encouraged to reduce exposures 
to some substances that may increase rather than decrease their 
overall health risks. A perfect example is mothers refraining 
from breast feeding in order to avoid feeding their babies 
chemicals found, or that may be found, in breast milk. In 
almost all circumstances, the benefits of breast feeding 
exponentially outweigh any possible risks from the mere 
presence of a chemical in the milk. This same advice is given 
to nursing mothers by public health authorities.
    For over 30 years TSCA has provided a scientifically sound 
framework for reporting, testing, tracking and restricting 
chemical substances and mixtures. As I have stated before I am 
open to the idea of modernizing the statute. But to the 
proponents of radical reform and supporters of the 
precautionary principle let me be very clear: my principles for 
any regulatory or statutory changes to TSCA must be based on 
the best available science, including risk assessment; must 
include cost-benefit considerations; must protect proprietary 
information; and must prioritize reviews for existing 
chemicals. Further, I will not support changes that encourage 
litigation, allow for activist enforcement, or that compel 
product substitution.
    I look forward to hearing from the witnesses here today and 
to the upcoming debate on how best to modernize TSCA.

    Senator Lautenberg. Thanks very much. I am particularly 
interested in this subject, as I am with anything that can 
protect our people and improve our general environment. My dad 
was 42 years old, worked in a mill, and he was a health 
enthusiast. He used to watch his diet, and in those days we 
called it workout in the gym, exercise. But he fell victim to 
cancer, as did his brother and as did their father, all three 
of them dying very young. My father was 43, and he was aware of 
the fact that there was danger in the mill, but he needed the 
job, and he stuck with it and paid a price for it. So that is 
deep in my thoughts.
    Senator Inhofe. Senator Lautenberg, also in our State of 
Oklahoma, you know, you are familiar with the Tar Creek 
Superfund Site, the most devastating site in the Nation. We had 
people that went through the same thing that your father went 
through. These are lead and zinc mines. And we are to the point 
now where we can actually do something to preclude things like 
that from happening, and that is what we are talking about 
today.
    Senator Lautenberg. Thank you.
    Our colleague from New Mexico, Senator Udall.

             OPENING STATEMENT OF HON. TOM UDALL, 
           U.S. SENATOR FROM THE STATE OF NEW MEXICO

    Senator Udall. Senator Lautenberg, thank you very much. I 
want to associate myself with your remarks. I think that you 
have really hit it on the head that we do not want to be 
experimenting with our young people, having them be guinea pigs 
in this experiment of putting more and more chemicals out into 
the environment and out in the ecosystems. So, I look forward 
to your piece of legislation that you are working on right now.
    I am reminded by my very able staff that it was 50 years 
ago today, Senator Lautenberg, more or less in that range, 
Rachel Carson wrote the book A Silent Spring. It was such a 
powerful book, and it said so much about how we were treating 
the environment, how we were treating all of the living beings 
in the environment. And people at that point became galvanized, 
and they got behind the idea of Government protecting people in 
terms of these toxic and hazardous chemicals. And I think 
people probably believe today that the Government is weighing 
in and doing that on a regular basis.
    Yet we have these national surveys, and I know there have 
been a lot of big national news stories, where if you take the 
blood of individuals in our society, there is a huge chemical, 
large number of chemicals, a chemical burden being carried by 
people. And that is something that worries me a lot.
    I want our panels to go forward, so, at this point, I just 
want to thank you for working on this issue. And I agree with 
Senator Inhofe, our Ranking Member. Science is the key here. We 
should be taking the very best science.
    But the Government should also be doing that work with the 
scientists, working with the universities, working with 
everybody out there that really knows the science. And then 
when we have the science, we put it into effect, and we protect 
the public. And I think that is the big gap that we have right 
now, would be my guess, if you ask many of the witnesses and 
the scientists around the country.
    So, thank you for doing this. It is great to be here today 
with you, and I look forward to hearing from the panelists.
    Senator Lautenberg. Thank you.
    Senator Vitter, the Ranking Member of the subcommittee, we 
welcome your comments.

            OPENING STATEMENT OF HON. DAVID VITTER, 
            U.S. SENATOR FROM THE STATE OF LOUISIANA

    Senator Vitter. Thank you very much, Mr. Chairman, and 
thank you for holding this hearing today.
    The first thing I would like to do is simply ask unanimous 
consent that the written testimony of the National 
Petrochemical and Refiners Association and the Society of 
Chemical Manufacturers and Affiliates be submitted for the 
record.
    Senator Lautenberg. Without objection.
    [The referenced testimony follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Senator Vitter. Thank you.
    Mr. Chairman, I want to echo several folks' words, 
including Senator Inhofe. You know, there is a lot of 
discussion about how do we balance ensuring human health and 
safety and a clean environment with competitiveness, et cetera. 
I think the answer is exactly what Senator Inhofe and others 
have been saying--sound science, complete focus on, complete 
reliance on, sound science above all else. In that spirit I 
want to quickly offer five points.
    First, I believe EPA should redo their inventory of 
chemicals in commerce. There are not 80,000 chemicals in 
significant commerce as we often hear. The number is probably 
closer to one-fourth of that, and we need to home in on the 
true universe that we should be concerned about.
    Second, a European Registration Evaluation and 
Authorization of Chemical Substances style program would likely 
kill innovation in the United States in my opinion and is a 
recipe for hamstringing small- and medium-sized manufacturers.
    Third, to assume that REACH is the wave of the future is 
entirely premature and could actually impair human safety by 
preventing critical products, helpful products, from entering 
the marketplace.
    Fourth, if the EPA decides to use any given study as a 
reason for limiting or terminating the use of a certain 
chemical the results of that study need to be repeatable and 
proven in further supporting studies.
    And fifth, if the EPA is going to decide to utilize 
resources to re-review a chemical prior to the necessary review 
period I think that review, that re-review, should sure as heck 
be based on sound science and not some New York Times article 
that utilized politicized science from an environmental group 
attempting to scare the public. And I think that is exactly, 
unfortunately, what has happened with the herbicide atrozine.
    I look forward to this discussion so that we do move 
forward with the complete focus on sound science.
    Thank you, Mr. Chairman.
    Senator Lautenberg. Thank you, Senator Vitter.
    Now, we will hear from our panel, the first of whom will be 
Mr. Stephen Owens.
    I would ask you to keep your remarks to 5 minutes or less. 
Our tolerance level is guided by the fact that we have a panel 
after you, and I know people are anxious to ask questions.
    So, please, Mr. Owens.

STATEMENT OF STEPHEN OWENS, ASSISTANT ADMINISTRATOR, OFFICE OF 
PREVENTION, PESTICIDES AND TOXIC SUBSTANCES, U.S. ENVIRONMENTAL 
                       PROTECTION AGENCY

    Mr. Owens. Thank you, Chairman Lautenberg, Ranking Member 
Inhofe and other members of the subcommittee. I want to thank 
you for the opportunity to be here and to discuss the need for 
reforming chemical risk management in this country.
    As EPA Administrator Lisa Jackson testified before the full 
Environment and Public Works Committee last December the public 
does expect the Government to provide assurances that chemicals 
have been assessed with the best available science and that 
unacceptable risks have been eliminated, and restoring 
confidence in our chemical management system is a top 
environmental priority for not only EPA but for the Obama 
administration.
    The Toxic Substances Control Act, or TSCA as it is called, 
regulates chemicals in commerce. When TSCA was enacted in 1976, 
however, it grandfathered in the roughly 60,000 chemicals that 
existed at that time without any evaluation whatsoever. 
Manufacturers were not required to provide the data needed to 
adequately assess potential risks from these chemicals, and EPA 
was not given adequate authority to reevaluate existing 
chemicals as new concerns arose or as new scientific 
information became available.
    And even for new chemicals manufacturers are not required 
to provide the data necessary to fully assess a chemical's risk 
without further action by EPA. And, even when EPA has adequate 
data on a chemical TSCA prevents us from taking quick and 
effective regulatory action.
    Consequently, over the last 30 years, as you noted, Senator 
Lautenberg, EPA has been able to require testing on only around 
200 of the nearly 84,000 chemicals currently listed on the TSCA 
inventory, and moreover to date only 5 chemicals have been 
regulated under TSCA's ban authority.
    The Obama administration has articulated several principles 
for modernizing TSCA. First, chemicals should be reviewed 
against safety standards that are based on sound science and 
reflect risk-based criteria protective of human health and the 
environment.
    Second, the responsibility for providing adequate health 
and safety data should rest on industry, and EPA should have 
the tools to obtain information from manufacturers without the 
delays and obstacles currently in place and without excessive 
claims of confidentiality.
    Third, EPA should have clear authority to take risk 
management actions when chemicals do not meet the safety 
standard with flexibility to take into account a range of 
considerations including children's health, economic costs, 
social benefits and equity concerns.
    Fourth, EPA should have clear authority to review and act 
on priority chemicals in a timely manner with firm deadlines to 
maintain accountability.
    Fifth, we must encourage innovation in green chemistry and 
support more sustainable chemicals and processes.
    And finally implementation of the law should be adequately 
funded with manufacturers supporting the costs of agency 
implementation.
    Because science has evolved substantially since TSCA was 
enacted 33 years ago we need to be able to take advantage of 
new approaches in modeling and testing methods that will assess 
risk more quickly and efficiently. With so many chemicals now 
being found in our bodies we need to better understand the 
implications of cumulative exposure to multiple chemicals. 
EPA's Office of Research and Development is developing 
computational tools that will help us address these questions 
and evaluate thousands of chemicals in less time and for less 
cost.
    Because we know that legislation will take time 
Administrator Jackson has directed my office to use our current 
authority under TSCA to the fullest extent possible to protect 
the American people and the environment.
    As part of this effort in December we released action plans 
for several chemicals, phthalates, long-chain perfluorinated 
chemicals, polybrominated diphenyl ethers and short-chain 
chlorinated paraffins. We also are currently developing action 
plans on benzadine dyes and bisphenol A, otherwise known as 
BPA.
    These chemicals were chosen for action by us on the basis 
of multiple factors including available hazard, exposure and 
use information, potential concern for children's health, use 
in consumer products, presence in human blood, persistent, 
bioaccumulative and toxic or PBT characteristics, toxicity, and 
their production volume. And we will use these criteria to 
select additional chemicals for future action plans as well.
    We are moving forward to use the tools currently available 
to us to increase the public's access to chemical information 
as well. While there are certainly legitimate reasons why a 
company may sometimes need to claim confidentiality it is also 
clear that confidentiality claims have been made far too often 
by far too many companies in far too many ways. Indeed, of the 
roughly 84,000 chemicals included on the TSCA inventory the 
identity of more than 16,000 of these chemicals is currently 
classified as confidential. That is simply unacceptable.
    To begin addressing this problem, last month we announced 
that companies will no longer be able to claim confidentiality 
for the identity of chemicals that present substantial health 
and environmental risks when those chemicals already are on the 
public portion of the TSCA inventory. Moreover, last summer we 
removed confidentiality for over 500 chemicals because the 
information claimed as confidential already had been made 
public elsewhere by companies.
    Mr. Chairman, as we are taking action let me reemphasize 
our view that the current law simply is not sufficient to 
adequately protect the American people and the environment. It 
is time to bring TSCA into the 21st century.
    Thank you again for the opportunity to be here, and I will 
be happy to answer any questions that you may have.
    [The prepared statement of Mr. Owens follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Senator Lautenberg. Thank you very much, Mr. Owens.
    Dr. Falk, we welcome your testimony.

 STATEMENT OF HENRY FALK, M.D., MPH, ACTING DIRECTOR, NATIONAL 
 CENTER FOR ENVIRONMENTAL HEALTH, CENTERS FOR DISEASE CONTROL 
  AND PREVENTION AND AGENCY FOR TOXIC SUBSTANCES AND DISEASE 
     REGISTRY, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Dr. Falk. Thank you very much.
    Good morning, Chairman Lautenberg, Senator Boxer, members 
of the subcommittee. My name is Henry Falk, and I am the Acting 
Director of the National Center for Environmental Health at the 
Centers for Disease Control and the Agency for Toxic Substances 
and Disease Registry.
    I am pleased to appear here today before the committee to 
discuss CDC's work in assessing people's exposure to chemicals. 
My testimony will focus on the Biomonitoring Program at CDC.
    For at least three decades CDC has been assessing people's 
exposure to chemicals through biomonitoring, which is the 
direct measurement of chemicals or their metabolites in people, 
in their blood, urine and other tissues. It determines which 
chemicals and how much of them get into people after they have 
been exposed. CDC's Biomonitoring Program assesses the U.S. 
population's exposure to chemicals and conducts targeted 
studies to examine vulnerable populations.
    CDC's Fourth National Report on Human Exposures to 
Environmental Chemicals was released in December 2009. Findings 
showed evidence of widespread exposure in the U.S. population 
to some commonly used commercial chemicals such as bisphenol A, 
BPA, the perfluorinated compound known as PFOA, and a type of 
fire retardant known as BDE-47. The report also noted continued 
progress in reducing children's exposure to lead.
    The data in the exposure report provide unique exposure 
information to scientists, physicians and health officials to 
help identify and reduce or prevent exposures and potential 
health effects that may result from human exposure to 
chemicals.
    Each year CDC's Environmental Health Laboratory works with 
States, other Federal agencies, academic institutions and 
international organizations on 50 to 70 studies that examine 
vulnerable populations, particularly newborns, children, 
pregnant women, and population groups or communities known or 
likely to have higher exposures.
    For example one important current partnership is with the 
Eunice Kennedy Shriver National Institute of Child Health and 
Human Development at the National Institutes of Health. This 
partnership involves a pilot study of 525 pregnant women in 
which CDC is lending analytical and biomonitoring expertise. 
Scientists at CDC's Environmental Health Lab will measure 
chemicals in pregnant women's blood and urine and after 
delivery in the newborns' cord blood and mothers' breast milk. 
Cord blood is a promising way to assess prenatal exposure to 
certain chemicals. Urine, at times, is a better way to measure 
exposures to chemicals that pass through the body more quickly.
    Biomonitoring is one important tool for identifying and 
preventing health problems. For example, biomonitoring has been 
a key tool in some landmark public health actions including the 
reduction of exposure to lead. CDC has been measuring lead 
since 1976. Lead is highly toxic, especially to young children, 
and can harm a child's brain, kidneys, bone marrow and other 
body systems. Our laboratory analysis showed that the American 
population's blood lead levels were declining in parallel with 
declining levels of lead in gasoline, providing critical 
support for the Environmental Protection Agency regulations 
that reduced lead in gasoline.
    CDC results for the period from 1999 through 2004 show that 
only 1.4 percent of children age 1 to 5 had elevated blood lead 
levels. At one time there was actually 88 percent, in the late 
1970s. This progress is a direct result of collaborative 
efforts by CDC, EPA, NIEHS and others.
    In conclusion, biomonitoring provides solid human data that 
can assist in making important health decisions. Better 
exposure information means that we can make better decisions to 
protect the health of the public.
    We are fully committed to continuing our work with other 
Federal agencies and partners to improve the uses and benefits 
of biomonitoring.
    And with that, thank you very much.
    [The prepared statement of Dr. Falk follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Senator Lautenberg. Thank you very much.
    Mr. Stephenson.

STATEMENT OF JOHN STEPHENSON, DIRECTOR, NATIONAL RESOURCES AND 
       ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY OFFICE

    Mr. Stephenson. Thank you, Mr. Chairman, Ranking Member 
Inhofe, who has gone, and members of the subcommittee. Thank 
you for the invitation to testify on our report to this 
committee on EPA's use of biomonitoring data.
    To help EPA achieve its mission of protecting human health 
the Toxic Substances Control Act, or TSCA, authorizes it to 
regulate the manufacture, processing and distribution of 
chemicals. To do so it must first do chemical risk assessments 
to determine the extent of exposure to a chemical and assess 
how this exposure affects human health.
    EPA uses such risk assessments to determine if it needs to 
take any risk management actions such as prohibiting or 
restricting the use of a chemical. As has been mentioned there 
are over 80,000 chemicals in the TSCA inventory, but about 6 of 
these are produced in significant volume today.
    The growing availability of biomonitoring data has provided 
new insights into the general population's exposure to 
chemicals and can be a valuable new tool in EPA's ability to 
assess chemical risk. Recent advances in analytical methods 
have allowed scientists to measure more chemicals in smaller 
concentrations in blood and urine samples. Biomonitoring 
measurements are very relevant because they identify the amount 
of a chemical that actually gets into people from all 
environmental sources such as the air, soil, water, dust and 
food.
    In one such example, CDC estimates that 90 percent of the 
population has detectable levels of BPA, a chemical widely used 
in plastic bottles and food and beverage cans. Some studies 
have linked this chemical to developmental problems. This data 
has raised concerns, fostering additional research by FDA on 
the health effects and led to a ban of the chemical in 
children's products in several States.
    In our April 2009 report to the committee we found that EPA 
has been able to make only limited use of biomonitoring data to 
date. One reason is that relevant biomonitoring data exists for 
only about 212 of the over 6,000 significant volume chemicals 
that EPA must monitor. And even less data is available for 
children.
    In addition, biomonitoring data alone indicates only the 
presence of the chemical in the body, not the source of 
exposure to the chemical or its effect on human health. Much 
more research is needed to understand if the levels measured in 
people pose a health concern.
    We also found that while EPA has taken a number of useful 
steps to better understand and use biomonitoring data it has 
not developed a comprehensive strategy for research that takes 
into account its own efforts and those of the multiple other 
Federal agencies involved in biomonitoring research. EPA does 
have several important efforts underway, as have been 
mentioned, including research into the relationships between 
exposure to harmful chemicals, the resulting concentration of 
those chemicals in human tissue, and the corresponding health 
effects.
    However, without a plan to coordinate its efforts EPA has 
no means to track progress or determine the resources needed in 
specific areas of biomonitoring research. Moreover, there is 
not overarching national biomonitoring strategy to coordinate 
initiatives across the Federal Government. As a result 
biomonitoring data indicating widespread exposure to dangerous 
chemicals such as flame retardants may go unaddressed, 
according to the National Academy of Sciences.
    Our report recommended that EPA develop a comprehensive 
research strategy to improve its ability to use biomonitoring 
data and work with the Executive Office of the President to 
establish an interagency task force to coordinate and leverage 
limited resources across the many Federal Government agencies 
involved in biomonitoring research including NIH, CDC, FDA, 
OSHA and USDA.
    Finally, as with many areas of TSCA we found that EPA's 
authority to collect biomonitoring data from companies is 
untested by the courts and may be limited. We recommended that 
EPA clarify to authorities, provide better guidance to industry 
and seek additional authorities from Congress if necessary in 
this area.
    EPA attempted to test its authority in a 2005 action 
against DuPont regarding the chemical PFOA in Teflon. DuPont 
had biomonitoring data on PFOA but argued that it was not 
reportable under section 8 of TSCA because the data indicated 
only the presence of the chemical and not the health effects. 
DuPont settled this and other claims for $16.5 million without 
admission that it was required to submit the data. As a result 
the court never ruled on EPA's authorities.
    In conclusion, Mr. Chairman, we believe that biomonitoring 
data offers great potential as a tool in assessing the risk of 
dangerous chemicals, but a coordinated national strategy is 
needed to facilitate to realization of this potential.
    Mr. Chairman, that concludes this summary of my statement, 
and I will be pleased to answer questions at the appropriate 
time.
    [The prepared statement of Mr. Stephenson follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Senator Lautenberg. Thank you.
    Ms. Birnbaum, welcome.

    STATEMENT OF LINDA BIRNBAUM, PH.D, DABT, ATS, DIRECTOR, 
 NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES, NATIONAL 
    INSTITUTES OF HEALTH, AND DIRECTOR, NATIONAL TOXICOLOGY 
     PROGRAM, U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

    Ms. Birnbaum. Mr. Chairman and distinguished members of the 
subcommittee, as Director of the NIEHS and the National 
Toxicology Program I am pleased to appear before you today to 
present testimony on recent science related to exposure 
assessment. This is all about understanding the environmental 
agents we are exposed to and then determining if these 
environmental exposures cause health problems for you and for 
me.
    From the days when readings from a single outdoor monitor 
was used to measure air pollution exposure for everyone in a 
city to the future when a badge is pinned on a shirt we will be 
able to give exposure readings of dozens of air pollutants for 
a single person. Our ability to measure personal exposure 
continues to improve significantly.
    While our technical capacity to measure exposures continues 
to improve we still have a ways to go in our general 
understanding of exposure in the United States. This is 
especially true for our most vulnerable populations like the 
unborn, infants and young children, and those living in poverty 
and disadvantaged communities.
    Biomonitoring, or the measurement of chemicals and their 
metabolites in blood, urine or other body fluids, has provided 
critical information on human exposure to toxic environmental 
agents. At NIEHS, we use biomonitoring to add precision to the 
measurements of exposures in our studies of specific human 
populations and to guide further research and understanding.
    For example findings of high levels of tungsten in the 
urine of residents of Churchill County, Nevada, the site of a 
childhood leukemia cluster, prompted my National Toxicology 
Program to initiate studies on tungsten, which have been 
followed by additional studies in collaboration with NIOSH for 
levels of tungsten in workers.
    NTP studies of the chemicals paraben, triclosan and 
oxybenzone were similarly prompted by CDC findings of 
widespread exposure. Other biomonitoring studies revealed 
unexpected rising levels of the polybrominated flame retardants 
in women of child bearing age and PFOA in residents near 
chemical plants, leading to intensive toxicological and 
epidemiological investigations and some changes in the use of 
these chemicals.
    Sometimes, biomonitoring is initiated for chemicals known 
to be toxic in order to better understand risk for an affected 
population. Substances like DEHP and other phthalates, certain 
heavy metals in pesticides, and other toxic substances fall 
into this category.
    Biomonitoring can also demonstrate the effectiveness of 
regulatory controls. An NIEHS study of infants in New York City 
documented lower cord blood levels of the harmful pesticides 
diazanon and chlorperifos after EPA implemented a ban on 
residential uses. And the good news is that the adverse effects 
we had seen in the infants no longer occurred when the levels 
of diazanon and chlorperifos dropped.
    Looking to the future, the NIEHS is developing 21st century 
methods of assessing exposures. For example, the NIEHS leads 
the Exposure Biology Program of the trans-NIH Genes, 
Environment and Health Initiative and is funding 32 research 
projects focusing on the development of innovative technologies 
to measure environmental exposures, diet, physical activities 
and psychosocial stress. The program also supports the 
development of biosensors to monitor the body's biological 
responses to environmental exposures.
    The NIEHS is even supporting the development of a robot 
capable of mimicking a child's floor activities so that we can 
measure exposures to young children more accurately. Other 
activities include the use of computerized geographical 
tracking systems like GPS to improve exposure modeling and 
using nanotechnology and biosensors to improve the detection of 
chemicals.
    Devices under development include a biosensor for detecting 
formaldehyde in air; I should have said that is a microsensor, 
nanobiosensors for probing chemical exposures and their effects 
on individual cells, wearable nanosensors, very small, 4 by 4, 
for monitoring diesel and gasoline exhaust, and low cost 
portable sensors for measuring metals such as arsenic and 
mercury at hazardous waste sites.
    In summary we are committed to advancing the science of 
exposure assessment to meet emerging public health challenges. 
We look forward to the increased contributions of exposure 
scientists as we work to understand the role of the environment 
in the etiology of disease.
    I would be happy to answer any questions.
    [The prepared statement of Ms. Birnbaum follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Senator Lautenberg. I would like to thank each of you for 
your testimony.
    As an observation, I am sorry that our colleague is not 
here because there is challenge as to what the number of 
chemicals is out there, and it is not said that all 80,000 of 
these chemicals are used on a regular basis. The number is 
quite a bit smaller. But that does not mean that these do not 
have an effect when in use and that we ought to be on guard.
    I have been joined by the Chairman of the committee, and if 
you are interested, Senator Boxer.
    Senator Boxer. I would just like to put my opening 
statement in the record. I will wait my turn for questions. 
Thank you.
    [The prepared statement of Senator Boxer was not received 
at time of print.]
    Senator Lautenberg. Thank you.
    Dr. Falk, of the more than 200 chemicals that were found in 
people's bodies, how many of these were known or are suspected 
to cause cancer or birth defects or other health problems?
    Dr. Falk. Of the 212 that were tested in the Fourth 
Exposure Report I believe that six are known carcinogens. They 
would be arsenic, benzene, beryllium, cadmium, environmental 
tobacco smoke and tetrachlorodibenzodioxen. They are 
categorized in that fashion. And there are a number that are 
characterized as possible or probably. So, yes, there are some 
included in there that would be considered carcinogens.
    Senator Lautenberg. Yes. Dr. Birnbaum, the mere presence of 
a chemical in the body does not necessarily mean that it is 
harmful. But cannot some of the chemicals cause harm to the 
sensitive populations in even very small amounts?
    Ms. Birnbaum. I think the question you are raising is a 
major one. The presence of a chemical does not in and of itself 
mean that there is a problem. It depends on the amount of the 
chemical. And not only how much of the chemical is present but 
the inherent susceptibility of the person in whom that chemical 
resides and the issue that I think Mr. Owens referred to of the 
cumulative exposure.
    We are not exposed to one chemical at a time. CDC has 
measured 212 different chemicals in our bodies. There are 
others that they have not yet begun to measure. And we really 
do not have a good handle on what happens when we have this 
multiplicity of chemicals in our bodies.
    Senator Lautenberg. Yes.
    Mr. Owens, there are thousands of chemicals in use every 
day, and EPA has to determine which of these to study and act 
on first. Do you feel that chemicals found in Americans' bodies 
ought to be prioritized for testing to determine whether the 
chemicals are safe in order to try and get some kind of a hold 
on this? Because otherwise there is so much out there that has 
been neglected and so much out there that is cause for alarm. 
What do you think about a prioritization of toxicity with the 
chemicals?
    Mr. Owens. Senator Lautenberg, we absolutely believe that 
there clearly are chemicals, clearly the entire 84,000 or 
whatever the actual number is of chemicals that are in 
widespread use in commerce. It would not be rated as the first 
order of business by the agency to look at chemicals.
    But the list of criteria that I laid out for what we used 
to develop our action plans, including a variety of things, 
both the PBT and the toxicity characteristics of production and 
early on exposure in children and the presence of chemicals in 
the blood, are certainly a good criteria, we believe, to use to 
begin that prioritization process to address the chemicals that 
represent what we believe would be the greatest risk to not 
only the population as a whole but especially to vulnerable 
populations like children.
    Senator Lautenberg. Yes. Mr. Stephenson, in your report you 
say that biomonitoring data alone indicate only that a person 
was somehow exposed to a chemical, but it does not have the 
source of the exposure nor its effect on the person's health. 
Can we identify the quantity of exposure, level of risk or the 
danger that a person is facing?
    Mr. Stephenson. Yes. That is why we are suggesting that 
additional research is needed on both ends to determine where 
the person likely obtained the exposure and what the resulting 
health effects might be with those quantities of that exposure 
and for that, for the duration that they may be in the body. 
That is where the research is not strong enough yet to support 
chemical regulation.
    Senator Lautenberg. Mr. Owens, the goal of my upcoming Safe 
Chemicals Bill is to give EPA the tools that it needs to keep 
dangerous chemicals out of our bodies. What changes need to be 
made to existing law for EPA to fulfill its mission of 
protecting public health and the environment from unsafe 
chemicals?
    Mr. Owens. How much time have we got?
    [Laughter.]
    Senator Lautenberg. Well, we have got enough time to 
listen.
    Mr. Owens. Senator, as I mentioned, the Obama 
administration, and these are Administration principles, not 
just EPA principles, have laid out a set of principles that 
identify some of the major items that we believe need to be 
addressed. And any updating and reform of the Toxic Substances 
Control Act, including setting a risk-based safety standard 
that is based on sound science so that the safety 
determinations are based solely on risk, the need to give EPA 
greater authority to obtain information from chemical 
manufacturers and shifting the burden from EPA to chemical 
manufacturers to produce that data and provide it to EPA, 
placing restrictions on the use of confidentiality when they 
submit data to EPA, giving us greater authority to make 
information public, as well as providing an adequate funding 
source for the agency so that when the program, assuming a 
reform occurs, ensuring that there is adequate funding in order 
to do the job that Congress would task us to do. So, a lot of 
different things would need to be done.
    Senator Lautenberg. I am struck particularly by the 
reminder that resource has to accompany our legislation. Thank 
you for that.
    Senator Udall.
    Senator Udall. Thank you, Mr. Chairman.
    The European Union has recently enacted a comprehensive 
chemical rule system that many of the world's large chemical 
companies will comply with. Does this mean that the European 
environmental regulators will have better information about 
exposures to their populations than we will have here in the 
U.S.? Any of you that would like to answer.
    Mr. Owens. Senator, if I may take a crack at that. I think 
the answer is, certainly for the time being, yes. And in fact, 
in our conversations with representatives of industry many of 
them are saying to us that they think that EPA ought to have 
the authority to get more information from them because in fact 
they are providing it, or will be providing it already, to the 
European Union through the REACH program.
    We are handcuffed at EPA because of the obstacles that TSCA 
puts on our ability to obtain information from industry. As I 
mentioned in my statement the manufacturers of these chemicals 
are not required to provide information to us, and if we take 
steps to ask if they would provide the information to us we 
have to make a number of very difficult showings as are 
outlined in the law before we can even get that information 
from them.
    So, the short answer is yes. But we are hopeful that in the 
long run we will be able to address that gap.
    Senator Udall. And all those hurdles you talked about that 
are put in place under TSCA that we are unable to get 
information, I assume that they are, the European Union 
regulatory system is getting directly to those issues, they are 
getting that information and that they have it and they have it 
available?
    Mr. Owens. Yes, Senator, that is correct.
    Senator Udall. Would any of you, please----
    Mr. Stephenson. Senator, may I make a comment on that?
    Senator Udall. Yes.
    Mr. Stephenson. The rub against REACH is that it does 
provide much more data on chemicals from the industry and does 
shift the burden, appropriately, I think, to the industry to 
prove its chemicals are safe rather than EPA to prove they are 
dangerous. But the problem is it is kind of one size fits all 
now. So, the problem is small chemical manufacturers may have 
to subscribe to the same information requirements that larger 
chemical manufacturers would.
    So, we would combine what REACH does with some sort of risk 
analysis of a given chemical, sort of like the Canadian program 
does right now, so that it is not one size fits all, and the 
burden of information provided by the industry is more based on 
the risk of the chemical that they produce.
    Senator Udall. Thank you. That is a good comment.
    Dr. Falk or Ms. Birnbaum, do you have any thoughts on this 
area?
    Ms. Birnbaum. I can make a brief comment which is I think 
that REACH will provide a great deal of additional information 
on the potential toxicity of chemicals. I do not believe that 
REACH will require biomonitoring in the population because the 
focus of REACH is to get information before chemicals begin to 
be used.
    Senator Udall. Now, Dr. Birnbaum, you said in your 
testimony, you said--and I think I have got this right but 
please tell me--we do not have a good handle on the impact of 
the multiplicity of chemicals in one's body. How do we--and 
this is for the whole panel--how do we get a good handle on 
that? What are the things that need to be done to get a good 
handle on the chemicals that we are all carrying around as a 
result of modern exposure?
    Ms. Birnbaum. I think this is a major research question, 
and we are beginning to try to develop ways to approach it. It 
has been done for small groups of chemicals. For example, the 
dioxin-like chemicals are looked at in toto as a group. People 
are beginning to look at all the chemicals that might have 
estrogen active activity, for example, that kind of hormonal 
activity and say, can we look at them as a group.
    We are going to have to begin to look at groups of 
chemicals, and then we are going to have to begin to look at 
the totality of the groups. And we are beginning to design 
approaches that we can actually ask that question in not only 
experimental animal or cell culture and then animal studies but 
also begin to ask the question in epidemiological studies.
    For example, we are finding effects, for example, on 
thyroid hormones from many, many, many different kinds of 
chemicals. And we need to understand if you have exposure to 
PFOA and if you have exposure to PCBs and if you have exposure, 
for example, to perchlorate, if all these things are going on, 
how much more likely is that going to be to impact your thyroid 
hormone system than exposure to one at a time?
    So, it is really still a research question but one which is 
very high priority and we are beginning to look at.
    Senator Udall. Thank you.
    Dr. Falk. Senator Udall, if I might reply to that.
    We have made a very extensive effort at CDC to actually 
organize this biomonitoring effort and develop it over the 
years. So, many years ago we would do individual analysis for 
specific chemicals. And approximately 8 or 9 years ago we began 
to do these biannual reports, National Exposure Reports, in 
which we assemble information on an ever increasing number of 
chemicals. So, we are up to 212 now. Undoubtedly, with advance 
of technology the numbers that we will be able to do in these 
roughly every 2-year reports will increase.
    So, there has been in a sense a logistical effort to 
organize this effort fully, the advance of the science and 
technology to actually be able to do more chemicals and the 
commitment to actually do this in a way that advances the 
science on the biomonitoring.
    Senator Udall. Thank you.
    Ms. Birnbaum. I would like to make----
    Senator Udall. I have run out of time----
    Ms. Birnbaum. OK.
    Senator Lautenberg. Senator Boxer, we are pleased to have 
the Chairman of the Environment and Public Works Committee with 
us.
    Senator Boxer. Thank you. Senator Lautenberg, first of all, 
I want to say how pleased I am at your leadership in this 
crucial issue. And I am very grateful to you. You have really 
run this subcommittee with an active agenda, and we are looking 
at the ways to protect our kids and our families, and I am on 
your team, you know that.
    I just wanted to make an announcement to the colleagues 
that are here that after the first vote at 12:30, we are going 
to meet off the Senate floor to mark up some non-controversial 
GSA, courthouses and such. So, if I could remind you to do 
that.
    And then if you want to start my time.
    I would say that we have a responsibility to America's 
families to ensure that the chemicals in the environment and 
the products they use have been scientifically tested and that 
they and their children are not put at risk. We do not have 
such a system. And it is a dangerous world out there for our 
kids. That is how I feel about it.
    The committee has the opportunity to strengthen our 
Nation's toxics laws to ensure that evaluations on the safety 
of chemicals are made based on science and public health and 
that all people, especially the most vulnerable, are protected. 
That is part of my statement. But I want to get to some 
questions. And then I will run out of time, and Mr. Chairman, 
with your permission I would like to be able to submit these 
questions to our witnesses.
    Senator Lautenberg. Without objection.
    Senator Boxer. The first one would be for Mr. Owens. Does 
the Toxic Substances Control Act give the EPA strong authority 
to fully understand potential health risks from chemicals and 
to prevent potentially dangerous chemical exposures from 
products purchased by consumers and used in the workplace? In 
other words, are you satisfied with the law as it is?
    Mr. Owens. No, Senator, we are not.
    Senator Boxer. OK. And that is why this is so crucial and 
Senator Lautenberg has taken the lead on making sure that this 
law is adjusted so that you can protect our people.
    Director Birnbaum, could you please describe the current 
state of science regarding health concerns over low level 
exposures to some chemicals in pregnant women, infants and 
children? In other words, there is an argument made by some of 
our colleagues who do not share our views on this that they are 
such small levels that they do not matter. But my view is, just 
from what I know about life and science, is that a pregnant 
woman is in great danger here for the child that she is 
bringing into the world. And I wonder whether that child is in 
great danger. So, could you discuss that?
    Ms. Birnbaum. I think there is growing evidence that 
developmental exposure can in fact have long lasting health 
consequences. And what we mean by low level has to be defined, 
and I think the important way to define it is what we actually 
find in people.
    And in fact, there are an increasing number of studies that 
demonstrate that the levels, these low levels that have been 
found in people in our animal studies are showing adverse 
effects on the developing animals, and in fact there are a 
growing number of human studies that are looking for 
associations in the studies where in fact we find that the low 
levels that are present in people are being associated with 
adverse impacts on their infants or as the children grow.
    Senator Boxer. So at this point I have to cut you off 
because I do not have a lot of time, but at this point we do 
not know of any safe level for a pregnant woman and the child 
she is bearing?
    Ms. Birnbaum. I think for many chemicals we just do not 
have the information about how low is low enough.
    Senator Boxer. OK.
    And Mr. Owens, I guess, Assistant Administrator Owens, some 
advocate, and I think this is where we are headed with Senator 
Lautenberg's rewrite of this law, some advocate changing the 
law to require the chemical industry to prove their chemicals 
are safe before they are put into products.
    Now, it seems to me that is logical. Do you think that is 
logical to say if there is going to be a chemical introduced, 
prove to us it is safe before we say fine?
    Mr. Owens. Well, yes, Senator, we do. In fact one of the 
Administration's principles is that there be a risk-based 
safety standard that products, I mean chemicals, would have to 
meet before they can go into commerce, and then if it is 
determined not be safe there would be risk management actions 
taken that include a variety of considerations that I 
mentioned. But yes, Senator.
    Senator Boxer. Thank you.
    Director Falk, Acting Director Falk, the CDC recently 
issued its Fourth National Biomonitoring Report. Can you 
describe the range of different chemicals this report covers, 
and do the findings show widespread exposure in children and 
adults to arrays of different types of chemicals or only to a 
narrow range of substances?
    Dr. Falk. The Fourth National Exposure Report actually 
covers more chemicals that we have ever looked at before. And 
in particular there are a number of substances that we have not 
measured in the past that appear to have widespread presence.
    Senator Boxer. Did you mention those?
    Dr. Falk. Yes. For example, bisphenol A, the polybrominated 
diphenyl ethers, PFOA, acrylamite, perchlorate, paraffins, 
benzophenones, triclosan, there is a whole series of new 
chemicals that we are measuring that we were not measuring 5, 
10, 15 years ago.
    Senator Boxer. Because they are showing up much more now?
    Dr. Falk. Because they are showing up, and we are concerned 
about them and measure them. And also because of the science 
advances, and we are now able to measure more of these in the 
kinds of samples that we have.
    So, yes, we are doing more chemicals, we are seeing their 
presence more, and for the chemicals that I mentioned just a 
moment ago most of them are present in most of the people. 
There are detectable levels in most people. So, that presents 
clearly an important area for all of us to evaluate in terms of 
what its potential impact is.
    Senator Boxer. Well, Mr. Chairman, I will close with this. 
There are two things, I think, that your hearings you have held 
here just cry out to me. One is we need to change the way we 
look at chemicals, which is to make sure they are safe before 
they get out there, and suddenly they are all in all of us, and 
we do not know what is safe and what is not safe. And the 
numbers of chemicals, as you point out, that are untested is 
just, it has just gotten away from us, and we have got to get a 
handle on it. That is No. 1.
    And No. 2, I think the public is going to cry out for us to 
take action the way we did, and Senator Klobuchar really 
deserves so much credit, just saying we are not going to allow 
certain toxins in toys, we are not going to allow them, you 
know, in plastics, and so on and so forth, because that is the 
immediacy. The public is not going to allow it.
    I have a bill for the EPA to set a standard for 
perchlorate. We had better do that. We know it is out there, 
everywhere, and you mentioned it. And we know in California it 
is out there. So, we need to set a standard. And we have to 
move.
    So, to me it is a two track situation--how we go about 
controlling these chemicals in the first place, and then once 
they are out and they are ubiquitous, if they are dangerous we 
had better move.
    And I want to say this. We have such a great committee. I 
am so proud of the members here. And I have to say Senator 
Lautenberg just plugging away at this, Senator Klobuchar 
heading a new subcommittee that deals with the safety of kids, 
and of course Senator Udall is here who is in on all of this 
and is pushing so hard.
    So, you know, I need to leave to go to another meeting, but 
I just want to thank everybody here and just say to my 
subcommittee Chairs, just please do your work because I am 
behind you every inch of the way.
    Senator Lautenberg. Thank you.
    Senator Klobuchar.
    Senator Klobuchar. Well, thank you very much, Senator 
Lautenberg. Thank you, Chairman Boxer, for your leadership. And 
thank you, Senator Lautenberg.
    We know it is important to update this law. It has been 30 
years, and think of how the world has changed and the products 
we are getting from other countries. So, I want to thank our 
witnesses for their testimony.
    When you talk about all these numbers as you have to do as 
we are setting the science here I think sometimes we forget 
what this really means in our communities. For me, I got 
interested in this when a little boy named Darnell Brown, who 
was 4 years old, swallowed a little charm he got with a pair of 
Reebok tennis shoes that his mom got. He didn't die from 
choking or from having his airway blocked. He died because the 
lead in that charm went into his bloodstream over a period of 
days. And when they tested the charm, it was 100 percent lead, 
and it led to one of, I think, the biggest fines ever against a 
company for what had happened there.
    Now we have a new chemical to fear with children's jewelry. 
We passed, as Chairman Boxer mentioned, the Consumer Products 
Safety Act. And Dr. Falk, you mentioned cadmium and that you 
had found it to be one of six toxic chemicals. Can you 
elaborate on that?
    Senator Schumer, Senator Gillibrand and I and a few others 
have a bill to ban this. I have talked to the head of the 
Consumer Products Safety Commission, Commissioner Tennenbaum, 
about what powers they have. And I do not expect you to go into 
that. But if you could give us some of the science and what you 
have seen with this chemical.
    Dr. Falk. As you know, we have faced in the last number of 
years many consumer products which have, particularly, lead, 
cadmium and a number of heavy metals which pose dangers to 
children. And this is a lengthening list of products. So, we 
consider this very important.
    Senator Klobuchar. Is this cadmium thing something, a 
chemical that you had seen before in----
    Dr. Falk. Yes. Cadmium has appeared in the biomonitoring 
reports as elevated a number of times. It is a clear concern in 
terms of health, in terms of kidneys and other diseases----
    Senator Klobuchar. Do you know what the toxic effects would 
be on kids?
    Dr. Falk. I do not want to actually comment on this 
specific instance.
    Senator Klobuchar. I understand.
    Dr. Falk. But of course children are very vulnerable to a 
variety of heavy metals, cadmium, lead and others. And I think, 
you know, we would very much want to limit the exposures to 
children of these chemicals.
    Senator Klobuchar. OK.
    Dr. Birnbaum.
    Ms. Birnbaum. I would just like to mention that we are 
funding a half-million dollar study right now to look at the 
impacts of cadmium exposure in children, especially focusing on 
cardiovascular risk. Most of the studies with cadmium 
previously have all looked at adults. We now know that cadmium 
is not only a carcinogen and a kidney toxicant and a 
reproductive toxicant, but it also is an endocrine disrupter, 
and we believe that is important to understand. So, we funded 
work to look at the role of cadmium and the impacts it will 
have long term of children's health.
    Senator Klobuchar. Right. And I will say, I think, for us, 
we banned lead, and we will put a trace level allowable, and 
now this new thing comes from China. So, we are very concerned 
about it and want to act quickly. I do think, unlike with the 
lead situation, the Consumer Products Safety Commission is 
acting quickly. A number of the retailers have taken these 
pieces of jewelry off their shelves, and we go from there.
    Just a second question. Formaldehyde. Senator Crapo and I 
have a bill that has vast bipartisan support and has already 
gone through this committee because of wood products and what 
we have seen there. Again, not American wood products. Our 
timber producers have agreed to a voluntary standard. I know 
there is some research going on with formaldehyde. Does anyone 
want to respond to that?
    Mr. Owens first.
    Mr. Owens. I'll just take a real quick crack at that. 
Senator, we are looking very closely at formaldehyde emissions 
from pressed wood products. My office, as well as the Office of 
Research and Development of the EPA, is looking at the 
emissions that come from those products, and we will be working 
toward trying to set a safety standard for that, a regulatory 
standard for that, as we get more information back based on 
that risk evaluation.
    Senator Klobuchar. Thank you.
    First Dr. Falk, and then Dr. Birnbaum.
    Dr. Falk. As you know, just about 2 years ago we did a 
study of 519 trailers to document the formaldehyde levels in 
them post-Katrina. And as part of that effort, we have been 
developing a longitudinal study to follow children who were 
exposed to formaldehyde in those trailers. So, that is in the 
process of being established, and that, hopefully, will add 
more information on the health effects in children.
    Senator Klobuchar. Yes. I think that is why the Senators 
from Louisiana are supportive of this bill. And they know we 
need to move quickly.
    Dr. Birnbaum.
    Ms. Birnbaum. We know that children are often subject to 
higher exposure just because they have a more rapid respiration 
rate than adults. So, we are concerned that children do have 
higher exposure, and you know, we have been talking to CDC 
about the study they are doing.
    I did want to mention that in our recent evaluation on the 
report on carcinogens, which is a congressionally mandated 
report, where we list chemicals as being known carcinogens or 
reasonably anticipate it to be a carcinogen; the expert peer 
panel which reviewed all the data came out with the conclusion 
that formaldehyde is a known human carcinogen.
    Senator Klobuchar. Very good. I have some additional 
questions on radon and carbon monoxide, also specific to the 
reauthorization that I will submit for the record. So, thank 
you very much for your time.
    Senator Lautenberg. Thank you very much, Senator Klobuchar.
    As you can see, there is a very active interest in the 
testimony that each of you has given, and thank you for it. It 
is very thoughtful and very helpful in our decisionmaking here.
    With that, we will bring up the next panel, which includes 
Molly Jones Gray, Ken Cook, Charles McKay and Tracey Woodruff. 
Thank you for being here with us. Your testimony is so 
important because while we do not necessarily want to believe 
the worst, what we want to do is protect again even the least.
    And why we have doubters who challenge whether or not there 
are 80,000 chemicals out there or what have you, the fact of 
the matter is that I know that you heard what the former 
panelists said, and it makes us--and I speak for myself and I 
think my colleagues--it makes us more determined to continue to 
wade through the opposition to even listen, to even accept, 
certain levels of conditioning that we have to get through. So 
we welcome you.
    Molly Jones Gray, we welcome you. We know you are from 
Seattle, Washington, and you are going to tell us something 
about chemicals that were present in your body during a 
pregnancy. I would ask you to start by giving us your 
testimony. It is limited to 5 minutes, but I am a little bit of 
a patient fellow.

 STATEMENT OF MOLLY JONES GRAY, PARTICIPANT IN A BIOMONITORING 
                             STUDY

    Ms. Gray. Thank you so much for having me. It is a great 
pleasure to be here today. My name is Molly Jones Gray, and I 
come before you today as a concerned mother.
    I recently participated in a study by Washington Toxics 
Coalition called Earliest Exposures. This was a study designed 
to find out what our developing fetuses are exposed to during 
pregnancy.
    The study tested for phthalates, mercury, BPA, PFCs, often 
referred to as Teflon chemicals, and a flame retardant. Many of 
these substances are known to have adverse health effects. Of 
the ones tested I had higher than the national average for 
many. Of all the pregnant women tested I had the highest rates 
of mercury.
    During the 5 years preceding the study I had struggled with 
fertility and repeated miscarriages. And as I searched for an 
answer to why, why I was having such a hard time carrying a 
baby to term, I discovered the connection between our 
environment, our toxic exposures and our health, particularly 
our reproductive health.
    So, at that time I made reasonable changes in my life to 
reduce my exposure. I consumed mostly organic foods, I ate 
seafood only on the low mercury seafood list, I used personal 
care products without phthalates, and I avoided plastics, both 
cooking and storing my foods in plastics.
    So you can see when I first heard of the study, I was 
extremely interested in participating because I wanted to see, 
do my best intentions make a difference? And the answer I 
received was incredibly disheartening. I was shocked to see 
that my levels were as high as they were. This made me realize 
that the fight to avoid toxins is so much larger than just one 
person. These chemicals have become so ubiquitous in our 
environment that as clean as I tried to be, it was not enough 
to protect my little baby boy.
    Mothers-to-be, such as myself at the time, can make many 
choices to ensure a healthy pregnancy. We can take prenatal 
vitamins, we can eat a healthy diet, we can avoid cigarettes 
and alcohol, we can exercise. But of all the choices that we 
are able to make, we do not have a choice in this one. We 
cannot protect our babies from the powerful influence of toxic 
chemicals on their developing bodies.
    So now that my son is 7 months old and people hear my 
results they often ask me if my son is healthy. And my answer 
is, as far as I know, he is. He is a vitally healthy wonderful 
little boy. And pretty cute, too. He wanted to be here today, 
but this whole time difference he could not quite understand, 
and he is sleeping away in the hotel now.
    But what most alarms me now is that of the unknown. We have 
no idea what the long-term health implications of these results 
are. And I do not want my son or anyone's children to be our 
scientific experiment. Developing babies are uniquely 
vulnerable.
    Something is terribly wrong when I, as an educated 
consumer, am unable to protect my vulnerable baby. I, and all 
families, I feel, should be able to walk into a store and buy 
whatever products they need without wondering if the products 
that they are bringing home are putting their families' health 
at risk.
    Since participating in the study I have learned that 
companies can put chemicals into products without ever testing 
whether they harm our health. I think we need to change these 
laws.
    So, on behalf of my son Paxton and all other children I am 
asking for your help, help in lowering our body burden from 
these toxic chemicals that come between us and our health. In 
order to do that, I think policymakers should take immediate 
steps to eliminate the use of persistent toxic chemicals, the 
ones that build up in our body over time and are passed on to 
the future generations. I believe legislation should reduce the 
use of chemicals that have known serious health effects and 
ensure that only the safest of chemicals are used in our 
everyday products. And finally I think we need standards to 
protect our vulnerable populations such as pregnant women and 
their developing babies.
    So, in conclusion, I believe that babies deserve to grow in 
a healthy environment, both in utero and out. Instead, babies 
are born every day already exposed to chemicals that have known 
serious health effects. Safe until proven harmful is not good 
enough for me or my baby.
    And throughout the hearing today I have repeatedly heard 
that science is the key. So, I think that my role here today is 
to tell you that until we have that science, children such as 
my own, my Paxton, and all the other children are being 
affected by these laws.
    It will take time to rid out population of this burden on 
our bodies. We need to start now. This is not my story alone. 
This is the story of all of our children, our grandchildren and 
future generations.
    I appreciate this opportunity to tell my story. Thank you.
    [The prepared statement of Ms. Gray follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Senator Lautenberg. Thank you very much. I am very pleased 
that you could sit face-to-face with some of the doubters and 
talk about the apprehension and the struggle that you went 
through to conceive and to carry. But I am sure, as you have 
said, that not only is our child smart and all those things, 
but he is cute as well. We take your word for that. And thank 
you.
    Now, please, Dr. McKay, we invite your testimony. You are 
from the Hartford Hospital. That is Hartford, Connecticut, is 
it?
    Dr. McKay. Yes, it is.
    Senator Lautenberg. OK. Please.

STATEMENT OF CHARLES MCKAY, M.D., FACMT, FACEP, ABIM, DIVISION 
   OF TOXICOLOGY, DEPARTMENT OF EMERGENCY MEDICINE, HARTFORD 
                HOSPITAL, HARTFORD, CONNECTICUT

    Dr. McKay. Thank you, Chairman Lautenberg, and the rest of 
the committee and guests.
    I am coming to you today as a physician trained and 
certified in Internal Medicine, Medical Toxicology and 
Emergency Medicine and with a role to convey the information 
that is provided from biomonitoring data to patients and the 
public as well as to other professionals.
    I want to just comment that the comments I have are--I am a 
member of the Board of the American College of Medical 
Toxicology, but the comments here are my own and do not 
necessarily reflect the opinions of the Board of Directors or 
all of the members of ACMT.
    I do have material that I have provided for the written 
record that does come from the College as well as me.
    I would just mention that admission to the American College 
of Medical Toxicology is to advance quality care of poisoned 
patients and public health through physicians who specialize in 
consultative, emergency, environmental, forensic and 
occupational toxicology. And as a part of that role we do have 
an important mission to try and translate the information that 
comes from studies.
    I am not going to belabor the benefits of biomonitoring 
because I think that has already been adequately covered by the 
members of the first panel. But I also would like to mention 
some of the potential risks of taking biomonitoring information 
and miscommunicating that to the public.
    As a medical toxicologist I have to, on a daily basis, deal 
with people who have a concern that they have been poisoned or 
that their children have been poisoned because of the 
identification of chemicals from one study or another. And I 
have developed a way of responding that is, I hope, 
appropriately cautious while at the same time reassuring to 
people regarding both the response and adaptability of our 
bodies but also the difficulty of taking a given exposure, or 
exposures to mixtures, and then defining a response with any 
degree of surety.
    I would just list out for the committee several criteria 
that I think is very important as we try to communicate 
biomonitoring data.
    No. 1 would be that identifying a substance as being a 
public health concern is not the same as stating that it is 
causing individual harm. Biomonitoring data can help greatly 
here to try and identify the degree of exposure of individuals 
and how that does fit in with the population. Decisions about 
exposure need to incorporate information about at-risk 
populations and in particular whether the people that are 
expressing those concerns are actually members of that 
population as well as the benefits gained by use of the product 
or availability and potential adverse effects associated with 
the alternatives.
    Biomonitoring data alone does not answer all of these 
questions. But common sense certainly should play an important 
role. And I think members of the committee as well as the panel 
have mentioned some of those issues.
    In particular, I would like to comment on Dr. Falk's 
mention that we have nearly 2 percent of the population with 
measurable amounts of lead that exceed what are our current 
level of concern, whereas when most of us were growing up as 
children that was 90 percent. So, it is difficult as we 
approach zero on some chemicals to understand how there is a 
claim of continued, ongoing health risks from those when we 
were exposed to so much more as children. Or maybe it just 
actually identifies the degree of brain damage that we have as 
old adults.
    Claims of association of a medical condition, therefore, 
with historic exposures to some substances do need to be 
evaluated in the face of current exposures. So, for those 
elements and items that we have decreasing exposure to, then we 
need to recognize that that is true. Those that are increasing 
or have particular issues with biopersistence, that is where we 
need to focus our efforts.
    My point, though, is just that biomonitoring is not going 
to get rid of all of the potential confounders with our data 
that we are able to obtain. It is a very useful tool for 
documenting human exposure to environmental chemicals of 
concern, tracking trends in exposure, and prioritizing 
chemicals of most concern for possible regulation, restriction 
or substitution, consistent often with green chemistry 
principles that are being enunciated around the country.
    I would just mention that there is a role to be played by 
the State public health laboratories in actually rolling out 
some of these issues, and they should be funded for that 
purpose because that is what they are there for.
    I thank the committee for this opportunity to present my 
views as a practicing medical toxicologist and educator, and I 
would be happy to take any questions.
    [The prepared statement of Dr. McKay follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Senator Lautenberg. Thank you.
    And now, let us hear from Dr. Woodruff. You come from San 
Francisco, and you are--what is your responsibility?
    Ms. Woodruff. Should I just start then?
    Senator Lautenberg. OK. We will not charge you time.

    STATEMENT OF TRACEY J. WOODRUFF, PH.D., MPH, ASSOCIATE 
PROFESSOR AND DIRECTOR, PROGRAM ON REPRODUCTIVE HEALTH AND THE 
    ENVIRONMENT, DEPARTMENT OF OBSTETRICS, GYNECOLOGY, AND 
 REPRODUCTIVE SCIENCES, UNIVERSITY OF CALIFORNIA, SAN FRANCISCO

    Ms. Woodruff. Good morning, Chairman Lautenberg and members 
of the committee.
    My name is Dr. Tracey Woodruff. I am an Associate Professor 
and the Director of the Program on Reproductive Health and the 
Environment in the Department of Obstetrics, Gynecology, and 
Reproductive Sciences at the University of California, San 
Francisco.
    I would like to thank you for the opportunity to testify at 
this hearing. I am going to focus on three different things. 
One is concerning trends in reproductive and developmental 
health, current chemical exposures, and our policy needs.
    As Chairman Lautenberg noted, there are a number of 
numerous concerning trends in developmental health at the U.S. 
population. I am going to give a few examples of those. One is 
that more women in the U.S., particularly women under the age 
of 25, which is the peak time of fertility, are reporting 
difficulty in conceiving and maintaining pregnancy. The 
percentage has doubled from about 4.3 to 8.3 percent in the 
last 20 years.
    There are an increasing number of babies who are born too 
early--that is before the 37th week of gestation--which puts 
them at greater risk for death, learning and behavior problems 
and developmental delays. One out of 8 babies in the U.S. is 
born premature. That is a 36 percent increase since the 1980s.
    Birth weights are also declining, even among normal, 
healthy, full-term infants, which puts them more at risk for 
short- and long-term health complications and chronic disease. 
There is a new study that just came out showing that U.S. birth 
weights have declined about 1.5 percent between 1990 and 2005. 
But this drop is not explained by maternal and neonatal risk 
factors or obstetric practice.
    In my own State of California, gastroschisis, which is a 
birth defect where the abdominal wall does not form completely 
and the intestines intrude outside of the body, has increased 
by over 300 percent between 1987 and 2003. And we are of course 
seeing a number of different increases in childhood morbidity, 
including autism, certain childhood cancers, and obesity.
    I just would note that there are a number of these health 
trends and why there is a growing concern about toxic chemical 
exposures are covered in this new report titled The Health Case 
for Reforming the Toxic Substances Control Act.
    I would also say that we have very important and growing 
scientific evidence that there are periods of development that 
are more vulnerable to disruption by environmental chemicals, 
particularly if the exposures occur around the time of 
conception, during pregnancy, and early in childhood. In 
particular disruptions during the prenatal period can increase 
the risk of effects immediately, such as birth defects or pre-
term birth; in childhood, such as childhood cancers and 
neurodevelopmental outcomes; or even in adulthood, as was 
previously mentioned, such as increases in diabetes and 
cardiovascular disease.
    As has been noted, there are many chemicals that are now in 
use in our environment, in our manufacturing and daily lives, 
and chemical production since World War II has increased more 
than 20-fold.
    So now, environmental contaminants are ubiquitous in our 
air, water, food, personal care products and everyday household 
items, and has been mentioned, biomonitoring demonstrates these 
chemicals are also in our bodies. Anywhere from 70 to 100 
percent of the U.S. population have measurable levels of 
triclosan, PCBs, polyfluoroalkyl chemicals, parabens and 
bisphenol A.
    Many of these exposures come from every day use of products 
in our lives, such as personal care products, cookware and 
containers. These are sources that most people have previously 
considered to be inert, but they apparently are not.
    As a population, we vary in our biological susceptibility 
in terms of age, disease status and chemical exposures. And so 
when we consider the risk of adverse health effects from 
exposure to any one chemical that has been reported through 
biomonitoring studies, the National Academy of Sciences 
recommends that we consider this exposure in the context of 
existing chemical exposures and biological susceptibilities in 
the population. And they have concluded that we should not 
assume that there is a safe level of exposure to any individual 
chemical unless proven otherwise.
    As was raised by Dr. Birnbaum thyroid hormones and thyroid 
disrupting chemicals are reasons for concern. Thyroid hormones 
are essential for fetal brain development, particularly during 
the prenatal period, and pregnant women in the U.S., some 
portion of them, are already at risk for perturbations of 
thyroid hormone levels. Sixteen percent of women in the U.S. 
report having a thyroid disease, and about one-third of U.S. 
pregnant women have insufficient iodine intake, which is 
critical for maintaining sufficient levels of thyroid hormones.
    Some of the chemicals I have already mentioned, such as 
PCBs, the polyfluoroalkyl chemicals, perchlorate and triclosan, 
have also been shown to disrupt the thyroid system. And 
sometimes these chemicals can be at levels which are 300 to 
1,500 times higher than the levels of thyroid hormones in our 
bodies. So, we can be exposed to biologically relevant levels 
of these chemicals, and separate studies on PCBs and 
perchlorate have shown that.
    Our current approach of using biomonitoring data as a 
demonstration of a problem means that it is potentially too 
late for people who have already been previously exposed to 
environmental chemicals. There are many chemicals that we have 
sufficient data for the Government to take action to reduce 
exposures. But for many chemicals we simply do not have enough 
information to actually ascertain whether they are a problem 
for the public or not.
    Biomonitoring provides an excellent and appropriate tool 
for monitoring whether policy or regulatory actions that we 
have taken can prevent harmful exposures and whether we have 
been successful in those activities, such as with lead.
    The scientific data clearly shows that every child in the 
U.S. is born with a burden of multiple chemicals in their body 
which can impact their future health, and by taking policy 
actions now we can improve, as has been noted, the health not 
only of ourselves, but of our future generations.
    Thank you.
    [The prepared statement of Ms. Woodruff follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Senator Lautenberg. Thank you very much.
    And now, Mr. Cook, we welcome your testimony.

STATEMENT OF KENNETH A. COOK, PRESIDENT, ENVIRONMENTAL WORKING 
                             GROUP

    Mr. Cook. Mr. Chairman, thank you for convening this 
hearing. It is timely; it is vitally important. I very much 
welcome the opportunity to testify.
    Human exposure to toxic chemicals is exploding. You write 
your new legislation to fix the many problems with the Toxic 
Substances Control Act at a watershed moment in the science of 
understanding what we are exposed to and what it might mean.
    We got to know 10 Americans in a very unusual study a few 
years back. We tested them, one collection sample, 10 of them, 
1 day, we tested for 413 different toxic chemicals. No group of 
people has ever been tested for more. And we found in just 
those 10 people one sample, 1 day, 287 different toxic 
chemicals, chemicals of the sort that are used in consumer 
products in this room, chemicals that had been banned 30 years 
before we took the blood samples.
    Now, Mr. Chairman, they were not exposed by virtue of the 
food they ate, by virtue of the water that they drank, or by 
virtue of the air that they breathed. We do not know very much 
about these people personally. About the only thing we know for 
sure is that when the exposures took place, all of them looked 
something like this.
    This was the first time anyone had ever studied the wide 
range of chemical exposures in umbilical cord blood. Decades 
into the Chemical Revolution, no one had bothered to look. And 
this was the first broad look at the full range that we were 
able to afford spending $10,000 per sample.
    Now, we learned from this study that babies come into the 
world polluted. Toxic, industrial pollution begins in the womb. 
Now, no one that I know would claim that just because a 
chemical shows up in people, even in a baby in the womb, that 
there is a health risk we can definitely point to. But what we 
should be able to do, and tell every parent in America, is that 
if a chemical is found in your child, if the exposures are 
taking place in the womb, we ought to be able to be very 
certain those exposures are safe.
    This baby was receiving the equivalent of 300 quarts of 
blood a day circulating to him that kept him alive, nourished 
him, gave him the oxygen he needed, and carried these 
pollutants with the blood. This baby did not have a fully 
formed blood-brain barrier to protect him from toxic chemicals. 
And the other thing we know about this baby, who was not in the 
sample, I can tell you that, this baby is my baby. He was born 
in June 2008. He would be here today except for other pressing 
business that involved a red sled.
    [Laughter.]
    Mr. Cook. But I can tell you, Mr. Chairman, just by your 
action in 2005 and again in 2008, just by calling your bill the 
Kid-Safe Chemicals Act, you have invited tens of millions of 
people to understand in a way that they never would have before 
that this debate is not abstract, it does not involve 
smokestacks in the distance or in another town or in another 
part of the world. It involves them. I know it is difficult for 
you to give a public speech on almost any topic without 
invoking your grandchildren. Now that I have a son I understand 
exactly why that is.
    Mr. Chairman, we subsequently studied another 10 Americans, 
minority Americans, babies of African-American, Hispanic and 
Asian-Pacific heritage. We found hundreds more chemicals in 
them, dozens of neurotoxins, dozens of carcinogens, the thyroid 
toxin that Senator Boxer spoke about, showing up in the womb, 
bisphenol A, the chemical we are all worried about showing up 
in this baby even at that time.
    And low doses matter, Mr. Chairman. We know from the 
literature that 358 different chemicals have been found in 
babies already. But we also know from some popular chemicals 
that we are more familiar with that at very low doses you can 
have both profound therapeutic effects and also some fairly 
profound side effects. Here, for example, for a little over 60 
parts per billion you can inspire human reproduction, prevent 
it, and relax either way using Paxil. Low doses matter a great 
deal.
    It is true with children and industrial chemicals, too. 
Part per billion exposures has been associated of PFOS, an 
industrial chemical in PFOA, with reduced birth weight and head 
circumference, which Dr. Woodruff just mentioned. They have 
been associated in adults with difficultly in conceiving, 
different chemicals, PBDEs, thyroid disease, and heart disease, 
BPA in adults.
    We cannot avoid all these exposures, Mr. Chairman. We do 
live in the real world, and sometimes these kinds of exposures 
happen no matter what we try and do. But the truth of the 
matter is that if these exposures are going to take place we 
had better be careful not just because of the human toll but 
the economic toll.
    One study looking at just a small collection of childhood 
diseases estimated $55 billion per year in medical costs, 
parental leave costs, and school educational costs associated 
with that. And there are at least 182 other diseases associated 
with chemical exposure. We cannot say because the chemicals had 
caused it, but we can say it is an issue.
    And Mr. Chairman, unfortunately we are coming to this 
conclusion rather late. Why? We have not looked. We spend about 
$300 million a year testing dirt and water in this country 
through the Superfund program. Until very recently how much did 
we spend testing children under the age of 6? Almost nothing. 
Almost nothing.
    And so, Mr. Chairman, I would say, from our own studies, we 
have tested 200 people, we have found 482 chemicals. And there 
are 15,000 chemicals out there in heavy use. How many are 
showing up in our blood? How many of them might pose a risk 
alone or in combination? We do not know. One reason we do not 
is because the identity of these chemicals and their health 
effects are kept secret under current law through confidential 
business information claims.
    My little guy is doing great. I did not spend a minute 
during the pregnancy worrying that he was not going to turn out 
OK. But I spent a lot of time on Web sites, including my own at 
the Environmental Working Group, trying to figure out how to 
reduce exposures.
    And that is what parents want to know. When they come into 
a doctor's office, and they know they have a chemical in 
themselves or in their child, naturally they are concerned. But 
they are asking, is it a dangerous chemical? What can you tell 
me about it? Am I exposed? What levels? And if there is some 
way to avoid the exposure I will take that step, but why isn't 
the Government protecting me? Those are the questions we hear.
    Thank you, Mr. Chairman.
    [The prepared statement of Mr. Cook follows:]
    [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] 
    
    Senator Lautenberg. Thank you very much. I thank each one 
of you on the panel for your illuminating, to say the least, 
testimony.
    I want to ask Dr. McKay a question. Are you expressing a 
skepticism that is fairly deeply borne, if I heard directly 
what you are saying, that, for instance, using the lead 
example, taking some comfort that the presence of lead has gone 
down substantially? I do not know whether you are subscribing 
that to a natural phenomenon, but there is--lead is outlawed in 
many, many places. And as a consequence it looks like we have 
done the right thing.
    So, I am not sure where you were going when you made the 
comparison during the greater exposure to lead in our day, and 
my day was way ahead of yours. What was the point of that, 
please?
    Dr. McKay. Well, I think it is very complex. But the thing 
I would state is that when we demonstrate decreasing evidence 
or evidence of decreasing exposure to certain chemicals, we 
should not then argue that those lower levels are responsible 
for increasingly severe clinical effects, because that does not 
make sense.
    It also is a difficult thing for people to interpret, and 
they do not pay attention then to things that maybe are more 
important. Senator Klobuchar's efforts with the Consumer 
Products Safety Initiative are, I think, one example of that. 
If we eliminate lead that is in 100 percent concentration, in 
other words, a completely 100 percent lead charm that some 
child swallows and dies, that is a very good thing. To try and 
chase after 100 parts per million of lead in any component, or 
200 parts per million of lead, something that is a small 
fraction of a percent of lead in that product, not even being 
taken into the child in that amount, that is inappropriate 
because it takes the focus off of the----
    Senator Lautenberg. What would you, repeat for me please, 
what was a good thing that you saw?
    Dr. McKay. To take and eliminate the availability of 
heavily leaded products. That is a very good thing.
    Senator Lautenberg. And you use the term heavily?
    Dr. McKay. Yes.
    Senator Lautenberg. Low levels do not give you concern?
    Dr. McKay. Lower levels, as was mentioned by several of the 
speakers on the first panel, that is something that needs to be 
defined. I am saying that levels that have been put forward in 
legislation are so low as to not contribute to health problems. 
And it is difficult for people to then sort out those things 
they ought to be paying attention to----
    Senator Lautenberg. I guess I am one of those. I am not a 
paranoiac about a lot of things, but I am about children's 
health. And thanks, Mr. Cook, for mentioning my 10 
grandchildren.
    [Laughter.]
    Senator Lautenberg. You know, I keep a picture of them in 
my mind every day when I go to work because among the things 
that I do here is I keep the focus on children. And nothing is 
more painful than to see children with a disease that 
debilitates them and not be able to do things that healthy 
children should be able to do.
    In my 10 grandchildren, I have one with asthma. He does 
pretty well. But my daughter makes sure she knows where the 
nearest emergency clinic is when he goes out to play one sport 
or another. I have another child who came up with juvenile 
diabetes, and I am pleased at the progress that she is making 
and was pleasantly, pleasantly surprised to see her complexion 
and everything else at the first administration of insulin. It 
was just was wonderful. And among the other eight we have a 
very adequate distribution of allergies to all kinds of things.
    And if I could, if I did nothing in this, my term in the 
Senate, which has been pretty long, but to say to parents, do 
not worry about chemicals in kids' bodies because we know that 
those chemicals that are present cannot bring any harm, you 
cannot say that. And I do not know that it will ever be able to 
be said. But we are going to work on that. I have a mission.
    We spend billions of dollars purportedly protecting our 
society, protecting our people who live in America, to protect 
them from terrorism and violence and all that. But what kind of 
protection do we owe those beautiful little babies?
    I now consider myself a professional grandfather, and when 
I see kids, if they are just cute and nice, it makes me feel 
good, I can tell you, even though they are not mine. I would 
take them all, but I do not have room.
    [Laughter.]
    Senator Lautenberg. But I do want to ask you this, Mr. 
Cook. Your biomonitoring studies found more than 212 chemicals 
that were found by CDC. Could there be even more in our bodies 
than biomonitoring sciences have revealed so far? You mentioned 
that there were over 400. Is that--do you think that you have 
done the full gamut of study that has to be done?
    Mr. Cook. Mr. Chairman, not even close. I think because we 
have not been looking we have not found the chemicals that are 
in people. We have only just begun.
    We spent $10,000 per sample to study our first set of 10 
cord blood samples. We were able to study more chemicals 
because we were studying a smaller group. We do not purport 
that this is a group that is representative of the U.S. 
population or babies at all. It was a quick survey. But just 
developing the methods is important.
    Chemical companies are not obligated to tell EPA, under 
TSCA, how to find toxic chemicals in people, babies or 
otherwise. So, in many cases we have had to spend money to have 
the laboratory techniques developed to find some of these 
chemicals. And now we are finding them. Every time we look for 
more of them we are finding them.
    I would expect if you had enough money and you had enough 
sample, which you do not with cord blood, of course, you would 
probably find hundreds and hundreds if not thousands more 
chemicals in people in this country. And these are not people 
who are exposed occupationally necessarily. These are folks 
like all the rest of us go to work, type on a computer, talk on 
the phone, drive in a car, eat regular food. The chemicals are 
there.
    Senator Lautenberg. Thank you.
    Dr. Woodruff, EPA has overseen the regulation of pesticides 
for years and succeeded in taking some of the most dangerous 
pesticides off the market. My Safe Chemicals Bill will require 
testing of all chemicals under a standard similar to the one 
that applies to pesticides. Has EPA's restricting the most 
dangerous uses of pesticides substantially damaged that 
industry? Do you know?
    Ms. Woodruff. Well, I am not going to speak completely for 
the industrial healthiness of the agricultural industry, but 
suffice it to say we still have adequate food available for us 
in this country as well, which is one of the primary uses of 
pesticides in this country.
    I would say that, you know, EPA has gone through a process, 
because of the regulatory requirements for pesticides, to 
require data on active ingredients in pesticides, which gives 
them a pretty good indication about the potential for harm for 
active ingredient pesticides, which then allows them to assess 
the risks.
    And as mentioned by the previous panel some pesticides have 
been removed from the market, like chlorperifos, because of 
their identification as a potential developmental neural 
toxicant. And that has been very successful, also, as has been 
noted by some of the studies in New York City before and after 
the ban by EPA.
    What we have as a challenge is that for many chemicals we 
simply just do not know because we have no information. And I 
would point out that the absence of information right now is 
being used to assume something is safe. But really all it means 
is that we do not know anything about a chemical.
    And I think, as Mr. Cook was saying, that every time we 
find something new in these biomonitoring studies it appears 
that we have reached a threshold. But really what we have done 
is sort of identified the next set and that actually there are 
many, many more chemicals that could be out there, but we just 
do not know if they have been measured.
    I would offer an example of xyloxene, which is a chemical 
that has been proposed as a substitute for perchlorethylene in 
dry cleaning in California. I know about this chemical because 
we at UCSF are participating in partnership with a State of 
California biomonitoring study to measure chemicals in pregnant 
women and their infants.
    We have an interest in xyloxene because people have 
reported that this may be a chemical of interest and may be 
ubiquitous in the population. And we have been working with the 
State of California laboratories, as well as had some 
discussions with CDC, about could we measure this chemical, 
which we think is likely to be rather ubiquitous in the 
population.
    It has been very challenging because xyloxene is in many 
consumer products. It is so ubiquitous that CDC has not yet 
been able to develop a method that would--a clean method room 
such that their samples would not be contaminated, meaning that 
it is ubiquitous everywhere in our environment.
    We are not quite measuring it in people, and yet none of us 
really are talking about it because it has not emerged as 
something that we can measure, though there is concern about it 
for exposures generally in the population and as potential 
health effects.
    Senator Lautenberg. Let me ask you this. So, are there new 
techniques for testing toxicity being developed so that 
scientists can move faster and with more accurate results 
without relying on animal testing? What might Congress do to 
accelerate the development and use of these newer testing 
techniques?
    Ms. Woodruff. This is actually a really very exciting area 
of research. There has been a report by the National Academy of 
Sciences, Toxicity Testing in the 21st Century, which has noted 
that we are entering a phase where we have the ability to test 
chemicals in cellular assays that we previously had not had 
before. And I know the National Institute for Environmental 
Health Sciences has been actively supporting a program for 
rapid testing of chemicals using non-animal methods but in 
cellular assays.
    I think there are sort of two keys pieces to this. One is 
further investments in the research side of this. But I think 
also, and I think EPA has mentioned this in their testimony 
earlier, is that we are going to be getting a lot of data from 
these things as the toxicogenome, epigenome evaluations. And 
how do we take that data and interpret it for the policymaking 
context?
    We are going to see lots of different signaling pathways 
perturbed. And yet we need to have more resources into the side 
that looks at, well, now that we have all of this data, how do 
we interpret it in the context of when we need to make a 
decision? Because as people have noted you are going to see 
probably many different signals going off, and how do we assess 
that in terms of the goals of trying to evaluate health risks 
from environmental chemicals?
    So, that would be my--I think you need to have both a 
research side, but you need to also focus on the research 
interpretation because science is very important. And as 
everyone has mentioned here, but it is very hard sometimes to 
interpret the science in the way that policymakers need, and I 
think we need to invest in that part as well.
    Senator Lautenberg. Thank you.
    Ms. Gray, the chemicals found in our bodies get there from 
many sources, air pollution, water pollution, food, and 
household products to name some of the biggest. Some of these 
sources are currently regulated by agencies other than EPA. Do 
you think that EPA ought to be able to review all exposure 
sources when deciding if a chemical is safe? I am kind of 
asking you an inside question here because it is--we do a lot 
of this review on this side of the table.
    Ms. Gray. It is an interesting question. I think for 
chemical reform to be meaningful, that the EPA has to take it 
all into account. Where are these sources? How are they ending 
up in our body? What are all the uses? How do they all add 
together?
    From a consumer standpoint, before preparing for today I 
most certainly did not know that different agencies regulated 
certain chemicals and others regulated other chemicals. And so, 
from that standpoint as a consumer, for me that piece does not 
matter as much as that we are not seeing these wind up in our 
bodies. And so I think in order to do that, we do. We have to 
think in the broadest of terms and really look at the big 
picture to see how this is happening.
    Senator Lautenberg. You cannot go far enough or deep enough 
to satisfy our obligation to make sure that things that are 
dangerous are discovered and at an early enough point in time 
so that they do not do any harm.
    Ms. Gray. Exactly.
    Senator Lautenberg. We have noticed, for instance, a growth 
in the number of asthmatics in children who come up with other 
diseases at birth and whether or not we are seeing an evolution 
of disease that is connected to the chemical exposures or other 
exposures. But we sure ought to find out because these 
conditions are tough. And you see the growing number of 
autistic children being born on a relative basis. It is a 
worrisome thing. And it has got to be more than a coincidence 
that things that they are exposed to. So, we have to do our 
research more thoroughly, finance wherever we can do it. And I 
thank you.
    We are joined by Senator Whitehouse. And what I am going to 
do, Senator, is to promote you to be Chairman. We have an 
excellent panel here, and I am sure that, knowing you, you have 
interesting questions to put forward. I know you are concerned 
about children's health and the environment generally, and 
during our working together I believe that you have a good way 
of getting to the bottom of things.
    Senator Whitehouse. Does this give me budgetary priority so 
I can----
    Senator Lautenberg. If I can give them.
    [Laughter.]
    Senator Lautenberg. And I want to say thank you to the 
witnesses.
    Senator Whitehouse [presiding]. I want to join the Chairman 
in thanking the witnesses but also take a moment to reflect on 
his own ardent leadership on these issues. It is important in 
the Senate for issues to have champions. When an issue has a 
strong champion, it is more persistently pursued, it is more 
vigorously pursued, it is more thoughtfully pursued, and it is 
ultimately more effectively pursued. And Senator Lautenberg has 
for a long time been a very significant champion on these 
health issues, particularly as it affects children's health. 
So, I am delighted to join him and feel, frankly, honored to 
share this panel with him.
    Senator Lautenberg. If I might----
    Senator Whitehouse. Are you going to rebut that?
    [Laughter.]
    Senator Lautenberg. No, I am not going to take it back. I 
am pleased with what you said, and I could listen for a long 
time.
    [Laughter.]
    Senator Lautenberg. But I want to enter two things into the 
record, if I might. One article that appears in Environmental 
News Focus about whether or not there are any safe levels of 
lead, which we seem to have a little bit difference of view 
here, and also a statement by the American Chemistry Council 
where they say that the Association and its member welcome 
congressional review of the Toxic Substances Act and lending 
their support to it. So, with that, I reinstate your 
Chairmanship.
    [Laughter.]
    [The referenced information was not received at time of 
print.]
    Senator Whitehouse. Well, I would like to ask two 
questions, and then I will conclude the hearing because I know 
that everyone has been here a long time. And I appreciate your 
testimony.
    The first has to do with the notion of asymmetry. We talk 
about, in the military context, asymmetrical warfare. And it 
strikes me that when you look at the number of chemicals that 
EPA actually regulates versus the explosion of chemicals that 
industry has produced in recent years, which we are, at this 
point, largely taking on faith, are not harmful, it is hard to 
see how under existing practices the EPA could ever catch up. 
They simply do not have the resources to do it.
    I do not know if you had the chance to talk in this hearing 
about what preferred model there is for addressing that 
asymmetry. We obviously do not want to stop industry from 
producing legitimate helpful products. But we also want to make 
sure that harmful products are kept out of our environment and 
kept out of our bodies as effectively as possible.
    I suspect that this situation is going to get, in terms of 
the asymmetry, is going to get a lot worse in the wake of the 
very surprising decision by the right wing activists of the 
U.S. Supreme Court that said that there could be no limit on 
what corporations could spend to influence political campaigns.
    When you get to a potentially narrow issue like whether a 
chemical should be regulated, the corporation that produces 
that chemical has an enormous interest in all of that. But in 
the array of interests that a public is concerned with at the 
time of an election it is not a very big one compared to 
everything else that is out there. It has to compete with every 
other issue for attention in a different way than the 
manufacturer sees that particular chemical.
    So, it worries me that that is going to get very 
asymmetrical, too, because a corporation could come into a 
candidate and say unless you support us on this, it is a minor 
matter, nobody ever needs to know about it, we are going to run 
a $3 million smear campaign against you the last 2 weeks of the 
election. We are going to do it through phony-baloney 
corporations that are very easy for us to set up, it is going 
to have a wonderful name like People for Trust, Justice, Apple 
Pie and the American Way, and it is going to point out 
everything negative that we can find out about you, and we are 
going to blanket the airways. Your choice. Are you with us, or 
are you against us? And I think that is a very dangerous 
proposition.
    So, I think the imbalance presently between the public 
health effort to protect against these chemicals is about to 
undergo a systemic blow which makes the question of trying to 
fix it and resolve the asymmetry all the more important.
    Let me ask Dr. McKay if he would speak first to that and 
then perhaps Ms. Woodruff.
    Dr. McKay. Well, I obviously cannot speak to any of the 
manufacturers testing and all, but Dr. Falk and Dr. Birnbaum 
spoke earlier on the possibility and likelihood of being able 
to cluster compounds within areas of effect or likely effect. 
And several things have been mentioned throughout this hearing 
about the importance of thyroid function, particularly during 
neonatal development. So, that would be a way of addressing 
classes of compounds by likely areas of effect.
    The problem with blaming a given compound for an effect 
that it turns out not to have, we have seen, unfortunately, 
very well exhibited by the discredited studies looking at 
thimerosal as a preservative in vaccines, multi-dose vaccines. 
Now that that study that started the anti-vaccine campaigns has 
been withdrawn, all that is left in its wake for the last 20 or 
so years is the number of children who have developed Hepatitis 
B, measles, and died because of lack of vaccination. But none 
of them have been prevented from harm from exposure to that 
ethylmercury compound.
    Senator Whitehouse. So, we want to get it right on both 
sides. You do not want false alarms.
    Dr. McKay. Right. Exactly. So you want to be able to 
identify substances that truly do have a high likelihood of 
having an adverse effect. If they are already out in commerce 
those are the ones to be removed or regulated restricted.
    But at the same time the benefit of whatever those products 
are that they are in should not be lost. And you know flame 
retardants are one that has been discussed, and I think that is 
important if we identify those as the culprit for some of the 
effects that are blamed on them. But I would not want to have 
more fires because of the lack of flame retardants.
    Senator Whitehouse. So, your best recommendation at this 
point is to expand the scope of the regulatory process so that 
it is by chemical category and not just by individual chemical 
so that more can be, the regulatory process can be used more 
efficiently.
    Dr. McKay. I think that is a component of it. But then, 
each, you would still have to regulate each chemical within 
that category based on some decision process. And to determine 
whether something is safe or not is really a difficult question 
because everybody's definition of safe has to incorporate the 
substance that that chemical is in, what is provided by it. The 
people in Haiti right now are I think very happy to get the 
water that is being delivered to them in a plastic jug that has 
bisphenol A leaking out of it. That cannot be done through 
glass containers or other kind of distribution networks.
    There is always a risk-benefit process, and if there are 
chemicals that are identified as high risk, and that I believe 
is EPA's job, it is the manufacturer's responsibility I think 
to do that as well. But then decision has to be made about 
which ones have to have the highest priority and where the line 
is drawn between more benefit and more risk.
    Senator Whitehouse. Ms. Woodruff.
    Ms. Woodruff. Yes, I think you bring up a really excellent 
point because as people have mentioned there are thousands of 
chemicals, yet EPA has been very challenged in terms of 
evaluating them and often when they do do the risk assessments 
they can be extraordinarily slow, formaldehyde, 
trichlorethylene, dioxin, all chemicals which EPA is still 
doing a risk assessment on even though it has been 10 to 20 
years.
    And I think there are two parts to the answer to your 
question. The first is the research part, which is, as I had 
previously mentioned, we have a whole new arena of scientific 
tools in terms of toxicity testing that are before us that we 
should invest in.
    I think also we need to move what we have called upstream 
to looking at more of early biological perturbations in terms 
of adverse health effects. Thyroid hormones is a perfect 
example where we should be looking to see if chemicals cause 
thyroid hormone disruption and not wait to see the note about 
metal outcome. The science is quite clear in this area, and EPA 
is quite legitimate in terms of moving up to more early 
indicators which would make the testing process more efficient.
    Senator Whitehouse. Unfortunately, the----
    Ms. Woodruff. Could I just say one more thing?
    Senator Whitehouse. I was just elaborating on the one point 
you made, then please go ahead back to it. Unfortunately, 
industry has gotten quite good about sewing doubt about 
whatever scientific uncertainty there may be, even if it is 
only a 1 percent doubt.
    Ms. Woodruff. I should have listened to you because you 
actually led me to my next point, which was that science is 
only one part of the decisionmaking process. Clearly part of 
the challenge for EPA is making their decisions in the face of 
uncertainty and the fact that, as you mentioned, many different 
people have a stake in the outcome, and some people have more 
resources than others to sort of engage in that activity in 
terms of influencing the outcome.
    I think that it is challenging to try and address this 
through the policy process. But there are tools that have been 
identified, primarily through the research in the tobacco 
literature and the pharmaceutical industry influence on 
pharmaceutical drug literature, that show both how the industry 
can influence science but also tools that the Government can 
use to try and counter that type of influence. They include 
Sunshine Laws so that there is complete disclosure of 
information about who is participating in scientific research. 
There are also conflict of interest policies that can be put in 
place. The International Agency for Research on Cancer has a 
very nice set of conflict of interest policies that helps to 
minimize the influence of people who may have a vested interest 
in the research outcome.
    And then I would also say that this is an area that is ripe 
for research itself, much like the tobacco industry and the 
pharmaceutical industry, what we know about how the industry 
can influence the scientific and public policy process comes 
from actually basic research on that actual subject matter. We 
have no such research on the environmental health field. But 
you can imagine that it would be an appropriate place to have 
better information so that we can learn.
    I mean, it is a very difficult thing, as you mentioned, to 
try and counter. But currently we are not really actually 
applying all of the tools we could to really make a difference 
in terms of trying to minimize the conflict of interest and 
trying to balance the playing field in terms of how decisions 
are made.
    Senator Whitehouse. Well, it gets particularly difficult 
around here when members of the Senate reject the precautionary 
principle, which I think, Dr. McKay you have in your testimony.
    It seems a reasonable thought. Where there are threats of 
serious or irreversible environmental damage, lack of full 
scientific certainty shall not be used as a reason for 
postponing cost-effective measures to prevent degradation. It 
seems like a non-controversial principle. It is one that I 
suspect every one of us applies in our daily lives, taking 
reasonable precautions. If the fire alarm goes off in the 
night, and your children are asleep, there is of course a less 
than complete scientific certainty that there is a fire. It 
could be a spider got into the alarm system, it could be any 
number of things. But I think a prudent parent wakes up and 
goes downstairs and checks.
    And our blindness to that, particularly in this body, I 
think is a very dangerous development, and frankly it is an 
irrational development. It puts articles of faith ahead of 
logic and takes us back to, well, we had enlightenment for a 
reason, we had a year of rationality for a reason.
    But the time has expired. I just want to say I appreciate 
so much all of your testimony. I am sorry I did not have the 
chance to talk longer.
    Anybody seeking to add anything to the record of this 
proceeding has, I believe, a week to do so, and then the record 
will close.
    Again, with my gratitude to both panels of witnesses, this 
hearing is adjourned.
    [Whereupon, at 12:07 p.m. the subcommittee was adjourned.]
    [Additional statements submitted for the record follow:]

                 Statement of Hon. Benjamin L. Cardin, 
                U.S. Senator from the State of Maryland

    Mr. Chairman, thank you for holding this hearing today.
    Senator Lautenberg, I applaud your tireless efforts to 
reform toxic chemical regulation and look forward to working 
with you on forthcoming legislation to reform the Toxic 
Substances Control Act because reform of the process and 
methods for chemical testing and use determinations is 
desperately needed to protect the public health.
    There is no denying that the chemical industry has done 
miraculous things in the development of medical science, 
aeronautics and vehicle safety, energy efficiency and home 
improvement and many other modern conveniences. However, lax 
regulation backed by weak public protection laws has placed the 
public's safety at risk.
    The fact that water bottles, including baby bottles, 
containing bisphenol A, a known endocrine disruptor, are still 
being sold in this country is a perfect example of how 
ineffective our toxic chemical laws are at protecting the 
public.
    Fortunately, many large chain retailers like REI and Whole 
Foods Markets took it upon themselves to protect their 
customers by removing plastic bottles containing BPA from their 
shelves, thus sending a strong message to industry. Companies 
like Nalgene, makers of popular and durable water bottles 
reacted responsibly and quickly to market demands and changed 
their products to BPA-free plastics.
    While it's refreshing to know there are good actors in 
marketplace, we must not overlook that BPA plastic baby bottles 
are still manufactured and sold by retailers all across the 
country. By and large this is an environmental injustice that 
impacts the health of children because people living in 
underserved communities often do not have access to retailers 
that sell a wide variety of alternative plastic products that 
are known to be safe. Since chemical labeling is not required 
many consumers lack information about the safety of the 
chemical composition of the products they use every day.
    I am pleased that there is an effort underway right now in 
Annapolis to pass legislation to protect Marylanders, 
particularly children, from products containing BPA. However, 
reforms to Federal law to protect the public from BPA and other 
harmful chemicals are the more prudent way of addressing this 
issue.
    BPA, for better or worse, has become the poster child of 
the hundreds of potentially dangerous and loosely regulated 
chemicals that millions of Americans are exposed to on a daily 
basis. As we are sure to hear from testimony today, independent 
results from a variety of voluntary biomonitoring studies have 
found a wide range of chemicals in people from all walks of 
life.
    One particular study revealed the environmental justice 
component of this problem that I alluded to earlier. 
Biomonitoring tests were done of five environmental justice 
leaders who live and work in communities like the Gulf Coasts 
of Texas and Louisiana and Richmond, California, where 
residents breathe the air, drink the water, and share the land 
of their community with major chemical plants and oil 
refineries.
    The startling findings from the biomonitoring reports of 
leaders in communities that are subject to high chemical 
exposure revealed that they were in the higher percentiles of 
Americans with extremely elevated levels of chemicals like BPA, 
polycylic musks, mercury, perchlorate and lead. Beyond that 
these people tested positive for 37 or 45 of the 75 chemicals 
they were screened for.
    Many of the residents of these communities livelihoods are 
dependent on these companies, yet the chemicals these plants 
expose residents to also threaten their health as well.
    Children growing up in these communities and who are 
exposed to these chemicals during times in their lives when 
they are most vulnerable are the most at risk. Persistent 
exposure to certain chemicals affects brain and cognitive 
development, bone density, pulmonary and respiratory function, 
endocrine disruption and can cause cancer.
    I want to address a wide range of issues on chemical safety 
and work toward enacting legislation that improves regulatory 
authority and increases the public's access to information on 
the toxicity of the chemicals that pervade our daily lives.
    I thank the Chairman for holding this hearing, and I look 
forward to working with my colleagues on the committee to 
reform our national chemical control policy.

                 Statement of Hon. Kirsten Gillibrand, 
                U.S. Senator from the State of New York

    Thank you, Chairman Lautenberg, for holding this very 
important hearing.
    I'd also like to thank our witnesses who are here today and 
look forward to their testimony on these critical issues
    Mr. Chairman, the issues being explored today are central 
to the health and welfare of our country. As a mother of two 
young children, I am deeply and personally concerned about the 
exposure of the most vulnerable in our society to toxic 
substances.
    Over the past 34 years Americans have been unknowingly 
exposed to over 80,000 industrial chemicals through our air, 
food and water. Of this number, a staggering 60,000 were 
grandfathered into current law with little or no testing to 
determine the safety of these chemicals.
    The Toxic Substances Control Act or TSCA--signed into law 
in 1976--was designed to safeguard the Nation's health. This 
statute has failed. Today we see an increased risk of chronic 
diseases--some of which are attributable to environmental 
chemical exposure.
    The Safer Chemicals, Healthy Families Campaign recently 
issued a report that makes the case for reforming TSCA, which 
in turn may lead to reduced health care costs. Their report 
draws from over 30 years of environmental health studies that 
demonstrate that chemicals are playing a role in the increase 
in chronic diseases and disorders our Nation is facing.
    A study released in 2002 from researchers from the Mt. 
Sinai School of Medicine Center for Children's Health and the 
Environment in my home State of New York estimated that the 
toxic chemicals that our children are exposed to in air, food 
and water in the places we live, work, study and play are 
linked to 5 percent of childhood cancers, 10 percent of 
neurobehavioral disorders and 30 percent of asthma.
    As the mother of a child with asthma, this is a staggering 
statistic.
    The Mt. Sinai study further illustrates the quantitative 
cost of these exposures. It estimates that every year we spend 
more than $2.3 billion on medical costs related to childhood 
cancer, asthma and neurobehavioral disorders linked to 
exposures to toxic chemicals.
    Asthma is the leading cause of school absences for children 
aged 5 to 17 due to a chronic illness. Direct costs for asthma 
related medical expenses, including hospitalizations, account 
for nearly $10 billion.
    300,000 school-age children in New York State have asthma, 
with nearly 200,000 of those being elementary school age. In 
2005 alone the total cost of asthma hospitalizations in New 
York State was approximately $502 million for an average cost 
of $12,700 per hospitalization.
    If exposure to harmful chemicals is contributing to 
negative health effects in our children, it is our 
responsibility to act.
    Mr. Chairman, one chemical that has received a lot of 
attention lately is bisphenol A--commonly referred to as BPA. 
This is a chemical that has been linked to birth defects, 
obesity, certain cancers, and other neurological disorders.
    I am working with my colleagues, Senators Feinstein and 
Schumer, on two pieces of legislation concentrating on the 
threats of BPA. The BPA Free Kids Act and the Ban Poisonous 
Additives Act take significant steps to address the threats 
posed by BPA in food containers and products for our children.
    According to the Fourth National Report on Human Exposure 
to Environmental Chemicals, published by the Centers for 
Disease Control's National Center for Environmental Health, 90 
percent of Americans show traces of BPA in their urine.
    The widespread exposure of BPA currently in the bodies of 
every day Americans is staggering.
    Mr. Chairman, as I stated at the previous hearing on TSCA, 
when considering ways to modernize TSCA we must use the best 
science to dictate our efforts. We must learn from the failures 
of the past to ensure timely consideration and regulation of 
these chemicals. We must put forward the resources to ensure 
that regulators can do the work that Congress asks of them. We 
must work with industry to promote the development of new 
products that are both competitive in a global economy and safe 
for consumers.
    Mr. Chairman, thank you again for holding this important 
hearing, and I look forward to working with you and my fellow 
Senators on the committee as we look to bring the Toxic 
Substances Control Act into the 21st century.

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