[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4190 Introduced in House (IH)]
111th CONGRESS
1st Session
H. R. 4190
To amend the Public Health Service Act to authorize the National
Institute of Environmental Health Sciences to conduct a research
program on endocrine disruption, to prevent and reduce the production
of, and exposure to, chemicals that can undermine the development of
children before they are born and cause lifelong impairment to their
health and function, and for other purposes.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
December 3, 2009
Mr. Moran of Virginia (for himself, Mrs. Lowey, Mr. George Miller of
California, Ms. McCollum, Mr. Grijalva, Mr. McGovern, Mr. Hinchey, and
Mr. Kennedy) introduced the following bill; which was referred to the
Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To amend the Public Health Service Act to authorize the National
Institute of Environmental Health Sciences to conduct a research
program on endocrine disruption, to prevent and reduce the production
of, and exposure to, chemicals that can undermine the development of
children before they are born and cause lifelong impairment to their
health and function, and for other purposes.
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled,
SECTION 1. SHORT TITLE.
This Act may be cited as the ``Endocrine Disruption Prevention Act
of 2009''.
SEC. 2. FINDINGS, POLICIES, AND GOALS.
(a) Findings.--The Congress finds that--
(1) a disturbing increase in the number of disorders of the
human endocrine system is seriously undermining the health and
wealth of the Nation;
(2) these disorders include attention deficit hyperactivity
disorder (ADHD), autism, learning disabilities, asthma,
juvenile cancer, juvenile and adult diabetes, autoimmune
diseases, cryptorchidism, hypospadias, endometriosis, obesity,
osteoporosis, testicular cancer, male dysgenesis syndrome,
breast cancer, prostate cancer, Parkinson's disease, and
Alzheimer's dementia;
(3) these disorders began to increase noticeably at the
population level in the early 1970s when the first generation
exposed in the womb to post-World War II synthetic chemicals
reached maturity;
(4) prior to 1950, these disorders were rare, which rules
out the influence of inherited disorders;
(5) today, among the fourth generation of children exposed
in the womb, one in three children and one in two minority
children will develop diabetes; one in six children is born
with neurological damage; one in 100 children has an autism
spectrum disorder and among boys the occurrence is one in 58;
one in 125 boys is born with hypospadias, a condition where the
urethra does not open at the end of the penis; in 2007, an age-
independent decline in testosterone levels over the past twenty
years was discovered in American men; and declines in male
reproductive health have been traced back to damage in the
womb;
(6) evidence from human epidemiological and laboratory
animal studies links these disorders to prenatal and later life
exposure to endocrine disrupting chemicals (EDCs);
(7) the endocrine system is a complex system of organs
regulated by over eighty known hormones as well as hundreds of
auxiliary chemical signaling systems, and it assures the
perpetuity and integrity of human life;
(8) recent bio-monitoring demonstrates that embryos,
fetuses, infants, and children in the United States carry
hundreds of synthetic chemicals in their blood and tissue,
including EDCs, and similar results have been found for adults;
(9) thousands of chemicals have become an integral part of
confined environments (homes, schools, cars, planes, offices,
theaters, malls), contributing to continual, ubiquitous
exposure, and it is vital to be able to identify which are
EDCs;
(10) many plant and animal species are showing signs of ill
health due to exposure to endocrine disrupting chemicals, which
can cause small, but critical, changes in the chemical makeup
of an environment that are enough to trigger outcomes that
could lead to population decline and loss of biodiversity;
(11) one out of five male black bass in nine river basins
across the United States exhibit intersex organs and up to 100
percent of smallmouth bass at some sites in the Potomac River
basin during spawning season exhibit the same organ changes,
which scientists say suggests they have been exposed to EDCs;
(12) all vertebrates (fish, amphibians, reptiles, birds,
and mammals, including humans) are fundamentally similar during
early embryonic development, so scientists can use the evidence
acquired on other species to make predictions about endocrine
disrupting effects on humans;
(13) traditional toxicology and risk assessment, which
evaluate one chemical at a time, and only at high
concentrations, have failed to sufficiently address the effects
of low doses of chemicals at multiple early life stages and
have not prevented the alarming increase of endocrine disorders
sweeping across the Northern Hemisphere;
(14) since the early 1990s, independent government-funded
scientists in academic and institutional laboratories around
the world have published data demonstrating the ability of a
broad selection of chemicals to interfere with human
development and function by affecting a number of endocrine
mechanisms, and have discovered endocrine disruptive effects
for some widely used chemicals at concentrations several
thousand times lower than government ``safe'' levels derived
through traditional toxicological tests;
(15) these scientists have developed a new paradigm for
disease, the developmental basis of disease, which states that
disease starts during development and is influenced by
exposures to environmental chemicals, stress and nutrition
interacting on the developing organism;
(16) the developmental basis of disease changes the focus
from curing disease to prevention and to understanding gene-
environment-nutrition interactions during development;
(17) the National Institute of Environmental Health
Sciences (NIEHS) and the National Toxicology Program (NTP) have
conducted important studies on the environmental connection to
human diseases, and have in place a 5-tier scale of concern by
which to evaluate chemicals based on the weight of scientific
evidence and toxicity and exposure information;
(18) while research has established that exposure to EDCs
induces delayed toxicity that results in disease weeks, months,
years, or decades later in life, Federal regulatory agencies
generally are not using the results of this research to
restrict production and use of even the most egregious
chemicals;
(19) although Congress directed the Environmental
Protection Agency in the Food Quality Protection Act of 1996 to
develop, not later than August 3, 1998, ``a screening program
using appropriate validated test systems and other
scientifically relevant information, to determine whether
certain substances may have an effect in humans that is similar
to an effect produced by a naturally occurring estrogen, or
such other endocrine effect as the Administrator may
designate'', the Agency did not release test orders announcing
the availability of initial standardized screens and testing
protocols until October 21, 2009, and no chemical has been
tested for its impact on development and function from
fertilization to birth, despite the expenditure of more than
$100,000,000;
(20) given these delays and the alarming trends in
endocrine-related disorders, the United States must
expeditiously take preventive action based on an entirely new
approach to reducing children's exposure before birth to EDCs;
and
(21) the costs to society of not taking action include
medical expenses of treating these chronic diseases, lost
productivity, impaired fertility, compromised quality of life
for those affected, their families and communities, so
prevention is the key.
(b) Policies and Goals.--It is the policy of the United States--
(1) to promote family health and the perpetuation of the
human species as a paramount national goal, recognizing that in
order to protect the embryo, fetus, and infant during their
most vulnerable stages of development, parents' bodies must be
free of EDCs prior to conception, during gestation, and
throughout lactation;
(2) to prevent harmful exposure to EDCs in homes,
workplaces, schools, public and private transportation
vehicles, indoor and outdoor recreational environments, and in
drinking water, foods, and consumer products;
(3) to develop scientific support for Federal public health
strategies based on the entire body of peer-reviewed public
literature in an environment that is free from conflicts of
interest;
(4) to promote research into endocrine disruption by
encouraging the multidisciplinary, multi-institutional, and
international collaborations that in the past have produced
many breakthroughs in knowledge;
(5) to create graduate-level scholarships and post-doctoral
fellowships to train young scientists who can meet the demand
for technicians and public health and health care personnel in
endocrine disruption prevention;
(6) to determine which chemicals in commerce have the
potential to disrupt the human endocrine system and to remove
these chemicals, and products containing them, from the market;
and
(7) to prevent the introduction of new chemicals, and
products containing them, that have the potential to disrupt
the human endocrine system by requiring testing for these
effects before these chemicals and products are released on the
market.
SEC. 3. ENDOCRINE DISRUPTION PREVENTION PROGRAM.
Subpart 12 of part C of title IV of the Public Health Service Act
(42 U.S.C. 2851 et seq.) is amended by adding at the end the following:
``SEC. 463C. ENDOCRINE DISRUPTION PREVENTION.
``(a) Program.--The Director of the National Institute of
Environmental Health Sciences shall establish a program, to be known as
the Endocrine Disruption Prevention Program, consisting of research,
workshops, and fora under subsection (b).
``(b) Research, Workshops, and Fora.--
``(1) Research.--The Director of the Institute shall
conduct and support multidisciplinary research, to improve the
understanding of endocrine disruption. Such research shall--
``(A) include research to design and develop
sensitive tests to screen chemicals using assays that
are effective for identifying chemicals with the
potential to disrupt the human endocrine system;
``(B) address the full range of possible health
outcomes, including--
``(i) male and female developmental and
reproductive disorders;
``(ii) brain (behavioral and intellectual)
disorders;
``(iii) metabolic syndrome, pre-diabetes,
diabetes, improper glucose and fat metabolism,
obesity, and cardiovascular disorders;
``(iv) effects on the pituitary,
hypothalamus, hippocampus, thyroid, adrenal,
immune, bone, cardiovascular, and other
endocrine organs and systems throughout all
life stages;
``(v) hormonally driven cancer; and
``(vi) other related effects;
``(C) be appropriately sensitive to detect a
chemical's potential to disrupt the human endocrine
system at ambient exposure dosing levels;
``(D) consider the potential for additive and
synergistic effects and need not be based solely on
expectations of monotonic effects where the dose
reflects the toxicity;
``(E) be carried out using a multidisciplinary
approach to assure connections among multiple levels,
from molecular to organ to whole animal or human
research; and
``(F) be designed to develop biomarkers of exposure
and effect that can be further developed and translated
for use in human epidemiological and public health
studies focused on defining the role of endocrine
disrupting chemicals in disease etiology across the
lifespan.
``(2) Workshops and fora.--
``(A) In general.--The Director of the Institute
shall conduct workshops and fora on the health effects
associated with environmental agents that may affect
the endocrine system in order to--
``(i) identify new chemicals of concern for
research under paragraph (1);
``(ii) strategize on approaches for the
development of sensitive tests to screen
chemicals for endocrine disrupting activity
using assays;
``(iii) review the state of the science and
provide recommendations for a research,
testing, and training agenda; and
``(iv) educate attendees about endocrine
disrupting chemicals.
``(B) Workshops.--
``(i) First workshop.--The Director of the
Institute shall invite the Secretary of the
Interior, the Administrator of the
Environmental Protection Agency, and the
Director of the Centers for Disease Control and
Prevention to participate in a workshop under
subparagraph (A) not later than 150 days after
the date of the enactment of this section.
``(ii) Subsequent workshops.--The Director
of the Institute shall convene subsequent
workshops under subparagraph (A) as the
Director determines appropriate.
``(iii) Participants.--The Director of the
Institute shall--
``(I) invite additional
participants to each workshop under
subparagraph (A);
``(II) in selecting such
participants, include scientists and
health professionals who are
knowledgeable about the endocrine
system and environmental exposures that
may influence the endocrine system;
``(III) select as participants only
those individuals who the Director
determines will participate in a manner
free of conflicts of interest; and
``(IV) in addition to the
participants invited under subclause
(I), allow representatives of
nongovernmental organizations to attend
each workshop under subparagraph (A) as
observers.
``(C) Fora.--At least every 3 years, the Director
of the Institute shall convene an open forum for all
stakeholders--
``(i) to review the state of the science
relevant to environmental agents that influence
the endocrine system; and
``(ii) to discuss the future direction of
the Endocrine Disruption Prevention Program.
``(c) Expert Panel.--
``(1) Establishment.--The Director of the Institute shall
establish an Endocrine Disruption Program Panel (in this
section referred to as the `Panel') not later than one year
after the date of the enactment of this section.
``(2) Members.--The Director of the Institute shall appoint
the members of the Panel from among individuals who--
``(A) have established expertise in the field of
endocrine disruption research by publishing research in
peer-reviewed literature;
``(B) provide assurances they will perform their
duties in a manner free of conflicts of interest (as
determined by the Director), including by complying
with section 208 of title 18, United States Code; and
``(C) represent diverse disciplines, including
developmental biology, endocrinology, developmental and
neurological biology, embryology, biochemistry,
physiology, epidemiology, endocrine driven oncology,
and medical research.
``(3) Duties.--The Panel shall--
``(A) provide advice to the Director of the
Institute on the conduct and support of research under
subsection (b);
``(B) evaluate existing population-level
biomonitoring and biobanking surveillance and research
programs and recommend changes needed to develop data
on human exposures and effects to support the Endocrine
Disruption Prevention Program; and
``(C) develop a list of chemicals of concern for
endocrine disruption effects and make findings with
respect to such chemicals in accordance with paragraph
(4).
``(4) Chemicals of concern.--
``(A) List.--The Panel shall--
``(i) develop a list of chemicals of
concern for endocrine disruption effects; and
``(ii) update such list annually.
``(B) Qualitative evaluation system.--The Panel
shall create a tiered qualitative evaluation system,
modeled after that of the National Toxicology Program,
in order to express the Panel's level of concern that a
chemical on the list under subparagraph (A) has the
potential to disrupt the human endocrine system.
``(C) Required findings.--For each chemical
identified in the list under subparagraph (A), the
Panel shall review peer-reviewed studies and other
relevant data and issue a finding, based on all of the
available evidence, regarding--
``(i) the level of the Panel's concern,
under the tiered qualitative evaluation system,
that the chemical has the potential to disrupt
the human endocrine system;
``(ii) the need for additional data to
determine the level of concern associated with
the chemical's potential to disrupt the human
endocrine system; or
``(iii) the need for assays to be developed
to provide the data necessary to support a
determination as to the level of concern
associated with the chemical's potential to
disrupt the human endocrine system.
``(D) Sufficient data.--If the Panel finds under
subparagraph (C)(i) that data are sufficient to
determine the extent to which a chemical has the
potential to disrupt the human endocrine system, the
Panel shall publish an explanation of this
determination and include the supporting data.
``(E) Minimal level of concern.--If the Panel finds
under subparagraph (C)(i) that data are sufficient to
determine (under the tiered qualitative evaluation
system established under subparagraph (B)) that there
is at least a minimal level of concern associated with
a chemical's potential to disrupt the human endocrine
system, the Panel shall describe the routes and sources
of exposure to the chemical that may cause effects to
human health.
``(F) Additional data needed.--If the Panel finds
under subparagraph (C)(ii) that additional data are
needed to determine the level of concern associated
with the chemical's potential to disrupt the human
endocrine system, the Panel shall--
``(i) identify such data; and
``(ii) recommend a process for developing
such data directly or by grant or contract.
``(G) Assays needed.--If the Panel finds under
subparagraph (C)(iii) that assays need to be developed
to provide the data necessary to support a
determination as to the level of concern associated
with the chemical's potential to disrupt the human
endocrine system, the Panel shall identify such assays
to the extent possible.
``(H) Annual report.--The Panel shall submit to the
Director of the Institute and to the Congress an annual
report on the Panel's activities. Each such report
shall include--
``(i) an updated version of the list
developed under subparagraph (A); and
``(ii) for each chemical on the list, the
findings and recommendations of the Panel under
subparagraphs (D) through (G).
``(I) No judicial review.--A finding or other
determination of the Panel under this paragraph shall
not be subject to judicial review, nor to correction
under section 515 of the Treasury and General
Government Appropriations Act, 2001 (commonly referred
to as the `Information Quality Act').
``(J) Petitions.--
``(i) In general.--Any person may petition
the Panel to determine whether a chemical
should be listed pursuant to subparagraph (A)
or revise a finding or other determination
under this paragraph based on new information.
``(ii) Rules.--The Director shall adopt
rules that provide for--
``(I) the form and procedure for
filing of petitions under this
subparagraph; and
``(II) the procedural rights of
persons filing such petitions.
``(d) Transmission of Certain Findings to Other Agencies.--
``(1) In general.--If the Panel finds under subsection
(c)(4)(C)(i) that data are sufficient to determine (under the
tiered qualitative evaluation system established under
subsection (c)(4)(B)) that there is at least a minimal level of
concern associated with a chemical's potential to disrupt the
human endocrine system, the Director of the Institute shall
transmit the finding, including the Panel's description of the
routes and sources of exposure to the chemical and any other
relevant information, to each Federal agency with authority to
regulate the chemical or the route or source of human exposure
to the chemical.
``(2) Public availability.--Whenever the Director of the
Institute transmits to one or more agencies a finding under
paragraph (1) regarding a chemical, the Director shall publish
in the Federal Register the names of the agencies and the
chemical.
``(e) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated such sums as may be necessary
for fiscal years 2011 through 2021.''.
SEC. 4. FEDERAL AGENCY ACTION.
(a) Requirements.--Upon receipt of a transmission under section
463C(d) of the Public Health Service Act, as added by section 3 of this
Act, containing a finding that there is at least a minimal level of
concern associated with a chemical's potential to disrupt the human
endocrine system, a Federal agency--
(1) not later than 180 days after the date of such receipt,
shall issue a reply in writing to the Director of the National
Institute of Environmental Health Sciences (in this Act
referred to as the ``Institute'') describing--
(A) the agency's authorities in connection with the
chemical;
(B) any past or ongoing actions taken by the agency
in connection with the chemical; and
(C) the proposed course of action to be taken by
the agency in response to the Panel's finding,
including but not limited to further testing by the
Institute or the issuance of regulations, orders, or
public notices under the agency's existing authorities,
in furtherance of protecting human health from the
potential endocrine disruption effects of exposure to
the chemical; and
(2) not later than one year after the date of such receipt,
shall submit to the Congress and shall publish a report
summarizing the actions taken by the agency in response to the
Panel's finding, as well as proposed future actions to be taken
by the agency.
(b) No Additional Regulatory Authority.--This section does not vest
any agency with additional authority to regulate a chemical or the
route or source of human exposure to a chemical.
(c) Citizen Suits.--
(1) Authority to bring civil actions.--Any person may
commence a civil action to compel any agency action required by
subsection (a).
(2) Jurisdiction.--The United States courts of appeals
shall have exclusive original jurisdiction over such an action.
SEC. 5. TRAINING IN FIELDS RELATED TO THE PREVENTION OF ENDOCRINE
DISRUPTION.
(a) In General.--The Director of the Institute shall establish a
program to support, directly or by making grants, graduate and
postdoctoral training in fields related to the prevention of endocrine
disruption.
(b) Authorization of Appropriations.--To carry out this section,
there are authorized to be appropriated $2,500,000 for fiscal year 2011
and such sums as may be necessary for fiscal years 2012 through 2021.
<all>