```

[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.
                                 <all>
```