Current Science On Public Exposures To Toxic Chemicals: Hearing
Current Science On Public Exposures To Toxic Chemicals: Hearing
Current Science On Public Exposures To Toxic Chemicals: Hearing
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HEARING
BEFORE 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
(
Available via the World Wide Web: http://www.gpo.gov/fdsys
U.S. GOVERNMENT PUBLISHING OFFICE
21160 PDF
WASHINGTON
2016
SUBCOMMITTEE
ON
SUPERFUND, TOXICS
AND
ENVIRONMENTAL HEALTH
(II)
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 ...........
Inhofe, Hon. James M., U.S. Senator from the State of Oklahoma ....................
Udall, Hon. Tom, U.S. Senator from the State of New Mexico ............................
Vitter, Hon. David, U.S. Senator from the State of Louisiana ............................
Cardin, Hon. Benjamin L., U.S. Senator from the State of Maryland, prepared
statement ..............................................................................................................
Gillibrand, Hon. Kirsten, U.S. Senator from the State of New York, prepared
statement ..............................................................................................................
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WITNESSES
Owens, Stephen, Assistant Administrator, Office of Prevention, Pesticides
and Toxic Substances, U.S. Environmental Protection Agency .......................
Prepared statement ..........................................................................................
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 .................................................................................................................
Prepared statement ..........................................................................................
Responses to additional questions from:
Senator Klobuchar .....................................................................................
Senator Inhofe and Senator Vitter ..........................................................
Stephenson, John, Director, National Resources and Environment, U.S. Government Accountability Office .............................................................................
Prepared statement ..........................................................................................
Responses to additional questions from Senator Inhofe and Senator
Vitter ..............................................................................................................
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 .........................................................................................................................
Prepared statement ..........................................................................................
Responses to additional questions from:
Senator Sanders ........................................................................................
Senator Klobuchar .....................................................................................
Senator Inhofe and Senator Vitter ..........................................................
Gray, Molly Jones, participant in a biomonitoring study .....................................
Prepared statement ..........................................................................................
McKay, Charles, M.D., FACMT, FACEP, ABIM, Division of Toxicology, Department of Emergency Medicine, Hartford Hospital, Hartford, Connecticut
Prepared statement ..........................................................................................
Response to an additional question from Senator Klobuchar .......................
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 .......................................................................................................................
Prepared statement ..........................................................................................
Responses to additional questions from Senator Inhofe and Senator
Vitter ..............................................................................................................
Cook, Kenneth A., President, Environmental Working Group ............................
(III)
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ADDITIONAL MATERIAL
Statement by Collin P. OMara, Secretary, Natural Resources and Environmental Control, State of Delaware .....................................................................
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U.S. SENATE,
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.
COMMITTEE
ON
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matic 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 Jacksonshe is from New
Jersey, I quickly mentionand 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 Nations 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
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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 biomonitoringone 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 tres-
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pass 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 costbenefit 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
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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
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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 sayingsound 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 rereview 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
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ceptable 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 chemicals 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 TSCAs 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 riskbased 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 childrens 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. EPAs 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
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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 childrens 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 publics 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:]
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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
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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 childs brain, kidneys, bone marrow and other body systems. Our laboratory analysis showed that the American populations 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:]
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Senator LAUTENBERG. Thank you very much.
Mr. Stephenson.
STATEMENT OF JOHN STEPHENSON, DIRECTOR, NATIONAL
RESOURCES AND ENVIRONMENT, U.S. GOVERNMENT ACCOUNTABILITY OFFICE
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cals, 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 EPAs 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
EPAs 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:]
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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
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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 bodys biological responses to environmental exposures.
The NIEHS is even supporting the development of a robot capable of mimicking a childs 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:]
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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 peoples 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 com-
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merce. 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 persons 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 worlds large chemical companies will comply with. Does this mean that the European environmental regulators will have better information about exposures
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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 saidand I think I have got this right but please tell mewe
do not have a good handle on the impact of the multiplicity of
chemicals in ones body. How do weand this is for the whole
panelhow do we get a good handle on that? What are the things
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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
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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 Americas 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 Nations
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.
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And Mr. Owens, I guess, Assistant Administrator Owens, some
advocate, and I think this is where we are headed with Senator
Lautenbergs 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 Administrations 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
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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 situationhow 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 didnt 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 childrens 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.
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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 childrens 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. Ill 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 postKatrina. 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 estab-
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lished, 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 usand I speak for myself and I think my colleaguesit 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
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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 anyones 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
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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:]
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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
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vidual 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. Falks 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:]
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Senator LAUTENBERG. Thank you.
And now, let us hear from Dr. Woodruff. You come from San
Francisco, and you arewhat 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
earlythat is before the 37th week of gestationwhich 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 longterm 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
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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
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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:]
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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
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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.
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And that is what parents want to know. When they come into a
doctors 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 isnt the Government protecting
me? Those are the questions we hear.
Thank you, Mr. Chairman.
[The prepared statement of Mr. Cook follows:]
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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 islead 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 Klobuchars 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 childrens 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
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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 thatdo 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
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to pesticides. Has EPAs 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 woulda 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?
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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 myI 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 iswe 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 dis-
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eases 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
childrens 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 childrens 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 pro-
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duced 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 be-
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cause 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 everybodys
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 EPAs job, it
is the manufacturers 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.
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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.
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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 publics 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 its 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.
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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 publics 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.
Id 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 TSCAsigned into law in 1976was designed to safeguard the Nations health. This statute has failed. Today we see an
increased risk of chronic diseasessome 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 Childrens 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
Acommonly 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 Controls 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.
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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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