[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[S. 1361 Introduced in Senate (IS)]
112th CONGRESS
1st Session
S. 1361
To reduce human exposure to endocrine-disrupting chemicals, and for
other purposes.
_______________________________________________________________________
IN THE SENATE OF THE UNITED STATES
July 13, 2011
Mr. Kerry introduced the following bill; which was read twice and
referred to the Committee on Health, Education, Labor, and Pensions
_______________________________________________________________________
A BILL
To reduce human exposure to endocrine-disrupting chemicals, 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-Disrupting Chemicals
Exposure Elimination Act of 2011''.
SEC. 2. TABLE OF CONTENTS.
The table of contents of this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
Sec. 3. Findings.
Sec. 4. Definitions.
Sec. 5. Tiering applicable to levels of evidence and concern.
TITLE I--RESEARCH ON ENDOCRINE-DISRUPTING CHEMICALS
Sec. 101. National toxicology program activities.
Sec. 102. Research program of national institute of environmental
health sciences.
TITLE II--REDUCING EXPOSURE TO ENDOCRINE-DISRUPTING CHEMICALS
Sec. 201. Federal agency action.
Sec. 202. Citizen suits.
TITLE III--TRAINING
Sec. 301. Training in fields related to the prevention of endocrine
disruption.
TITLE IV--MISCELLANEOUS
Sec. 401. Authorization of appropriations.
SEC. 3. FINDINGS.
Congress finds that--
(1) there is growing evidence that the human endocrine
system is extremely sensitive to particular chemicals;
(2) numerous studies show links between particular
chemicals and hormone functions in both animals and humans, and
those links have been further connected to numerous disorders;
(3) a research and evaluation program that targets
suspected endocrine-disrupting chemicals would establish
greater scientific certainty with respect to the linkage of
particular chemicals with endocrine system effects;
(4) credible linkages established by the research described
in paragraph (3) would establish a basis for regulation under
authorities that include--
(A) the Federal Insecticide, Fungicide, and
Rodenticide Act (7 U.S.C. 136 et seq.);
(B) the Food Quality Protection Act of 1996 (7
U.S.C. 136 note; Public Law 104-170);
(C) the Toxic Substances Control Act (15 U.S.C.
2601 et seq.);
(D) the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.);
(E) the Federal Water Pollution Control Act (33
U.S.C. 1251 et seq.);
(F) the Safe Drinking Water Act (42 U.S.C. 300f et
seq.); and
(G) the Clean Air Act (42 U.S.C. 7401 et seq.);
(5) the research described in paragraph (3), as well as
availability of information and the scientific perspective
derived from that research, would promote voluntary actions to
reduce exposure to those harmful endocrine-disrupting chemicals
through market forces;
(6) there is a need to educate the public on the results of
research on endocrine-disrupting chemicals so that
manufacturers, processors, retailers, and individual consumers
can make informed decisions about potential exposure to harmful
chemicals;
(7) people should be protected from chemicals that are
found to have endocrine-disrupting effects; and
(8) animal testing should be reduced to the minimum
necessary with the goal of transitioning to a predominantly
nonanimal paradigm as articulated in the 2007 National Research
Council report entitled ``Toxicity Testing in the Twenty-First
Century: A Vision and a Strategy''.
SEC. 4. DEFINITIONS.
In this Act:
(1) Chemical.--The term ``chemical'' means an individual
chemical, a combination of chemicals, or a mixture of
chemicals.
(2) Director.--The term ``Director'' means the Director of
the National Institute of Environmental Health Sciences.
(3) Endocrine-disrupting chemical.--The term ``endocrine-
disrupting chemical'' means a chemical that interrupts, alters,
interferes with, disturbs, or otherwise changes the human
endocrine system or cell functioning.
(4) Endocrine disruption expert panel; expert panel;
panel.--The terms ``endocrine disruption expert panel'',
``expert panel'', and ``panel'' mean the endocrine disruption
expert panel established under section 101(a)(2).
SEC. 5. TIERING APPLICABLE TO LEVELS OF EVIDENCE AND CONCERN.
In identifying, determining, or making a finding with respect to a
level of evidence or a level of concern under this Act (including under
sections 101(a)(3), 101(a)(4), 101(b)(2)(C), and 201(a)(2)(B)), the
Director or the expert panel, as applicable, shall select from among
the following levels:
(1) High.
(2) Substantial.
(3) Minimal.
(4) None.
TITLE I--RESEARCH ON ENDOCRINE-DISRUPTING CHEMICALS
SEC. 101. NATIONAL TOXICOLOGY PROGRAM ACTIVITIES.
(a) In General.--As part of the National Toxicology Program, the
Director, in consultation with the National Toxicology Program Board of
Scientific Counselors (or any successor board or committee), shall--
(1) establish and implement a research program designed to
strengthen the scientific basis of information used by Federal
agencies to understand the effects of, and reduce human
exposure to, endocrine-disrupting chemicals;
(2) subject to subsection (b)(1), establish an endocrine
disruption expert panel and direct the panel to consider and
report to the Director on issues relating to the
identification, classification, or evaluation of endocrine-
disrupting chemicals under subsection (b)(2);
(3) for each chemical determined by the Director to be a
potential or actual endocrine-disrupting chemical identify--
(A) the level of evidence that the chemical is or
may be an endocrine-disrupting chemical;
(B) the level of concern that the chemical may
disrupt the human endocrine system; and
(C) the pathways of exposure to the chemical for
humans and animals; and
(4) not later than 2 years after the date of enactment of
this Act and every 2 years thereafter, make publicly available
and submit to Congress and each relevant Federal agency--
(A) an up-to-date list that--
(i) specifies each chemical identified by
the Director to be a potential or actual
endocrine-disrupting chemical; and
(ii) identifies--
(I) the level of evidence that the
chemical disrupts the human endocrine
system;
(II) the level of concern that the
chemical disrupts the human endocrine
system; and
(III) the pathways of exposure to
the chemical for humans and animals;
and
(B) a report on--
(i) the activities of the National
Toxicology Program pertaining to endocrine-
disrupting chemicals; and
(ii) the activities of Federal agencies
with respect to endocrine-disrupting chemicals,
including actions taken or expected to be taken
pursuant to section 201.
(b) Expert Panel.--
(1) Appointment.--The Director, in consultation with the
National Toxicology Program Board of Scientific Counselors (or
any successor board or committee), shall appoint the members of
the endocrine disruption expert panel from among individuals
who--
(A) have established expertise in the field of
endocrine disruption research by publishing research in
peer-reviewed literature;
(B) have received Federal endocrine research-
related funding during the 2 years preceding the date
of appointment under this subsection;
(C) provide assurances that the member will carry
out the duties of that member 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
(D) represent diverse disciplines, which may
include endocrinology, developmental and neurological
biology, embryology, biochemistry, physiology,
epidemiology, endocrine-driven oncology, in vitro and
computational toxicology, and medical research.
(2) Duties.--For each of the 10 fiscal years following the
date of enactment of this Act, the expert panel shall--
(A) consider and report to the Director on issues
relating to the identification, classification, or
evaluation of not more than 10 endocrine-disrupting
chemicals or groups of endocrine-disrupting chemicals;
(B) evaluate existing research aimed at
understanding the biological pathways in humans by
which endocrine-disrupting chemicals operate and as
appropriate, identify future research priorities; and
(C) maintain a list that identifies chemicals of
concern for endocrine disruption effects, including
findings based on peer-reviewed studies and other
relevant data that relate to--
(i) whether a chemical is a potential or
actual endocrine-disrupting chemical;
(ii) the level of evidence that the
chemical is or may be an endocrine-disrupting
chemical;
(iii) the level of concern that the
chemical may disrupt the human endocrine
system;
(iv) the pathways of exposure to the
chemical for humans and animals; and
(v) the need for additional data, assays,
testing, or research to determine the level of
concern associated with the potential of the
chemical to disrupt the human endocrine system.
(3) Report.--The expert panel shall submit to the Director
and make publicly available a biennial report on the activities
of the panel, including an up-to-date version of the list under
paragraph (2)(C).
(c) Petitions.--
(1) In general.--Any Federal agency, State, local, or
tribal government, or person may petition the Director--
(A) to determine whether a chemical should be
identified by the National Toxicology Program to be a
potential or actual endocrine-disrupting chemical and
included in the list under subsection (a)(4)(A); or
(B) to reclassify a chemical, revise a finding, or
amend any other determination of the National
Toxicology Program based on new information.
(2) Rules.--The Director shall adopt rules that provide
for--
(A) the form and procedure for filing a petition
under paragraph (1); and
(B) the procedural rights of an entity that files a
petition under paragraph (1).
(d) No Judicial Review.--A listing, finding, or other determination
under this section shall not be subject to--
(1) judicial review; or
(2) correction under section 515 of the Treasury and
General Government Appropriations Act, 2001 (114 Stat. 2763A-
153).
SEC. 102. RESEARCH PROGRAM OF NATIONAL INSTITUTE OF ENVIRONMENTAL
HEALTH SCIENCES.
Subpart 12 of part C of title IV of the Public Health Service Act
(42 U.S.C. 281 et seq.) is amended by adding at the end the following:
``SEC. 463C. ENDOCRINE DISRUPTION RESEARCH PROGRAM.
``(a) Definitions.--In this section:
``(1) Chemical.--The term `chemical' means an individual
chemical, a combination of chemicals, or a mixture of
chemicals.
``(2) Endocrine-disrupting chemical.--The term `endocrine-
disrupting chemical' means a chemical that interrupts, alters,
interferes with, disturbs, or otherwise changes the human or
animal endocrine system or its functioning.
``(b) Endocrine Disruption Research Program.--
``(1) In general.--The Director of the Institute shall
conduct and support a research program, to be known as the
`Endocrine Disruption Research Program', to improve the
understanding of the manner in which chemicals can disrupt the
human endocrine system.
``(2) Contents.--The Endocrine Disruption Research Program
shall--
``(A) be designed--
``(i) to develop the information needed by
Federal agencies to understand chemical
disruption of the endocrine system and reduce
human and animal exposure to endocrine-
disrupting chemicals;
``(ii) to understand the cellular pathways
in humans by which endocrine-disrupting
chemicals are able to cause adverse effects;
and
``(iii) to use laboratory practices that
will produce data that are sufficiently
accurate and reproducible to be used for
regulatory decisions;
``(B) include research to design, develop, and
validate appropriately sensitive tests to screen and
identify chemicals capable of disrupting the human
endocrine system;
``(C) address the full range of potential human
health impacts, including--
``(i) male and female developmental and
reproductive disorders;
``(ii) brain and neurobehavioral disorders;
``(iii) metabolic syndromes, prediabetes,
diabetes, improper glucose and fat metabolisms,
obesity, and cardiovascular disorders;
``(iv) effects on the pituitary,
hypothalamus, hippocampus, thyroid, adrenal
system, immune system, bones, cardiovascular
system, and other endocrine organs and systems
throughout all life stages;
``(v) hormonally driven cancer; and
``(vi) other related effects;
``(D) consider the potential for additive and
synergistic effects;
``(E) be carried out using a multidisciplinary
approach to ensure connections among multiple levels,
including the molecular, organ, and whole animal or
human levels;
``(F) refine computational modeling tools to
integrate cellular pathway data into a dose-response
framework for risk assessment;
``(G) identify 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; and
``(H) ensure that research or testing involving
living animals is carried out only when equally
effective and reliable alternative approaches for
obtaining the result sought are not readily available.
``(c) Workshops and Forums.--The Director of the Institute may
conduct workshops and forums and provide information on the health
effects associated with chemicals that may disrupt the endocrine
system--
``(1) to identify chemicals for research under subsection
(b);
``(2) to strategize on approaches for the development of
sensitive tests to screen chemicals for endocrine-disrupting
activity using assays;
``(3) to review the state of the science on endocrine-
disrupting chemicals and provide recommendations for a
research, testing, and training agenda; and
``(4) to educate attendees about endocrine-disrupting
chemicals.''.
TITLE II--REDUCING EXPOSURE TO ENDOCRINE-DISRUPTING CHEMICALS
SEC. 201. FEDERAL AGENCY ACTION.
(a) Response to List and Strategy.--
(1) In general.--Not later than 90 days after receiving
each biennial list, strategy, and report under section
101(a)(4), each Federal agency with regulatory authority over
any chemical included on the list shall prepare and publish a
written response to the list and strategy.
(2) Contents.--At a minimum, the response of a Federal
agency under paragraph (1) shall--
(A) include an evaluation of the findings and
determinations of the National Toxicology Program
pertaining to each listed chemical subject to the
regulatory authority of that Federal agency; and
(B) adopt or modify, as scientifically appropriate,
each finding of the National Toxicology Program
pertaining to--
(i) whether the chemical disrupts or may
disrupt the human endocrine system;
(ii) the level of concern associated with
the potential of the chemical to disrupt the
human endocrine system; and
(iii) the pathways of exposure to the
chemical for humans and animals.
(b) Minimal Level of Concern.--If the Director finds under section
101(a)(3)(A) that there is at least a minimal level of concern that a
chemical may disrupt the human endocrine system each Federal agency
with regulatory authority over the chemical shall--
(1) develop a strategy for reducing human exposure to the
chemical that--
(A) is made publicly available not later than 180
days after the date on which the agency receives the
finding of the Director; and
(B) includes methods to promote voluntary actions
by industry for reducing human exposure to the
chemical; and
(2) take any necessary action under that regulatory
authority, including further testing or issuance of orders,
regulations, or public notices, to reduce or eliminate human
exposure to the chemical.
(c) Highest Level of Concern.--
(1) Prohibition.--Beginning on the date that is 2 years
after the date on which the Director makes publicly available a
finding under section 101(a)(3)(B) that there is a high level
of concern that a chemical may disrupt the human endocrine
system, it shall be unlawful to use the chemical in interstate
commerce or in a manner that affects interstate commerce,
unless the pathway to human exposure is mitigated before or in
conjunction with that use.
(2) Federal agency action.--Not later than the date that is
2 years after the date on which the Director makes publicly
available a finding described in paragraph (1), each Federal
agency with regulatory authority over the chemical subject to
the finding shall establish regulations or take other
appropriate actions to implement paragraph (1) with respect to
the chemical.
(d) Aggregated Computational Toxicology Resources Databases.--The
Administrator of the Environmental Protection Agency shall include the
findings and determinations of the National Toxicology Program
pertaining to endocrine-disrupting chemicals in the Aggregated
Computational Toxicology Resource (ACToR) databases (or any successor
databases) to the extent otherwise permitted by law, including any
restrictions on the disclosure of confidential business information.
SEC. 202. CITIZEN SUITS.
(a) Authority To Bring Civil Actions.--Any State, local, or tribal
government, or any other person, may commence a civil action to prevent
or restrain a prohibited use of a chemical in violation of section 201.
(b) Jurisdiction.--The United States Court of Appeals for the
circuit in which the person commencing the civil action resides shall
have exclusive original jurisdiction over an action described in
subsection (a).
TITLE III--TRAINING
SEC. 301. TRAINING IN FIELDS RELATED TO THE PREVENTION OF ENDOCRINE
DISRUPTION.
The Director shall establish a program to support, either directly
or by making grants, graduate and postdoctoral training in fields
relating to the study and prevention of endocrine disruption.
TITLE IV--MISCELLANEOUS
SEC. 401. AUTHORIZATION OF APPROPRIATIONS.
There are authorized to be appropriated to carry out this Act and
the amendments made by this Act such sums as are necessary for each of
fiscal years 2012 through 2021.
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