[Congressional Bills 107th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4709 Introduced in House (IH)]







107th CONGRESS
  2d Session
                                H. R. 4709

 To amend the Public Health Services Act to authorize the Director of 
the National Institute of Environmental Health Sciences to conduct and 
          coordinate a research program on hormone disruption.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 9, 2002

Ms. Slaughter introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
 Resources, and Science, for a period to be subsequently determined by 
the Speaker, in each case for consideration of such provisions as fall 
           within the jurisdiction of the committee concerned

_______________________________________________________________________

                                 A BILL


 
 To amend the Public Health Services Act to authorize the Director of 
the National Institute of Environmental Health Sciences to conduct and 
          coordinate a research program on hormone disruption.

    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 ``Hormone Disruption Research Act of 
2002''.

SEC. 2. FINDINGS.

    Congress makes the following findings:
            (1) Many compounds found or introduced into the environment 
        by human activity are capable of disrupting the hormone system 
        of humans and animals. The consequences of such disruption can 
        be profound because of the crucial role hormones play in 
        controlling development. No standardized and validated screens 
        or tests have been developed to routinely and systematically 
        assess chemicals for disruptive effects on hormone systems.
            (2) In the last 30 years, the United States has experienced 
        an increase in the incidence of such human disorders as 
        childhood cancers, testicular cancer, hypospadias, juvenile 
        diabetes, attention deficit-like hyperactivity disorders, 
        autism, thyroid disorders, and auto-immune disorders. Exposure 
        to hormone-disrupting chemicals may be contributing to these 
        increases. The impact on children's health as a result of 
        prenatal exposures in particular needs further research.
            (3) In 2001, the Centers for Disease Control and 
        Prevention's ``National Report on Human Exposure to 
        Environmental Chemicals'' reported on human exposure to 27 
        chemicals, and found unexpectedly high levels of certain 
        chemicals used in consumer products. The hazards to humans of 
        these chemicals, singly and in combination, are not well 
        understood.
            (4) Many wildlife populations have been affected by hormone 
        disrupting substances, including birds, fish, reptiles, and 
        mammals. The effects vary among species and compounds.
            (5) The effects in wildlife include thyroid dysfunction, 
        decreased fertility, decreased hatching success, gross birth 
        deformities, metabolic and behavioral abnormalities, 
        demasculinization and feminization of male organisms, 
        deformation and masculinization of female organisms, and 
        compromised immune systems. These effects may signal hazards to 
        human health.
            (6) Laboratory studies have corroborated studies of effects 
        in wildlife and have identified biological mechanisms to 
        explain the effects shown.
            (7) Since the chemicals found in wildlife are also found in 
        humans, humans are exposed to the same chemicals as wildlife.
            (8) Hormone disruption can occur at very low doses, 
        especially when exposure occurs in the womb or immediately 
        after birth, periods during which rapid development is 
        occurring.
            (9) In the Food Quality Protection Act of 1996 (21 U.S.C. 
        301 note), Congress recognized the special vulnerability of 
        infants and children to pesticides and requested that the 
        Environmental Protection Agency establish a program to screen 
        and test hormone disrupting chemicals. The Environmental 
        Protection Agency has not yet required such screening or tests.
            (10) In 1998, a research committee on hormone disrupters, 
        organized under the auspices of the Office of Science and 
        Technology Policy, concluded that ``scientific knowledge is 
        inadequate to fully inform public policy, and a government-wide 
        coordinated research effort that addresses the key scientific 
        uncertainties . . . is needed''.
            (11) In 1999, in response to a request from Congress and 
        funded through the Environmental Protection Agency and the 
        Department of the Interior, the National Academy of Sciences 
        compiled a lengthy list of research, monitoring, and testing 
        priorities related to hormone disruption.
            (12) The National Institute of Environmental Health 
        Sciences conducts much of the Federal Government's research on 
        hormone disruption, often working in partnership with other 
        agencies.
            (13) Congress fully supports critical research being 
        performed by the National Institute of Environmental Health 
        Sciences on methods to reduce, refine, or replace animal tests 
        in scientific and medical studies.
            (14) Congress strongly supports protection of animal 
        subjects and encourages all scientists to use alternatives to 
        animal testing to the maximum extent possible.
            (15) The United States Geological Survey (referred to in 
        this section as the ``USGS'') has considerable experience 
        assessing the occurrence of chemicals in the environment, 
        ecological health, and the hazards to wildlife health and 
        associated human health posed by chemicals in the environment, 
        as a result of monitoring by the USGS of the Nation's water 
        resources and wildlife disease, and research by the USGS on the 
        effects of chemicals on wildlife.
            (16) The National Academy of Sciences has recognized the 
        expertise of the USGS in such areas as food web contamination 
        and water quality assessment and has encouraged more 
        coordinated work on human health between the USGS and the 
        National Institutes of Health.

SEC. 3. AMENDMENT TO THE PUBLIC HEALTH SERVICES ACT TO PROVIDE FOR 
              RESEARCH ON HORMONE DISRUPTION.

    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 of the 
following:

     ``directed national program of research on hormone disruption

    ``Sec. 463B. (a) Study.--
            ``(1) In general.--The Director of the Institute shall 
        establish within the Institute a comprehensive program to--
                    ``(A) conduct research on the impact of chemicals 
                that affect human health through disruption of the 
                hormone systems;
                    ``(B) conduct research on the occurrence of hormone 
                disrupting chemicals in the environment and their 
                effects on ecological and wildlife health, in 
                cooperation with the United States Geological Survey 
                (referred to in this section as the `USGS');
                    ``(C) coordinate the design of a multi-agency 
                research initiative on hormone disruption;
                    ``(D) coordinate research on hormone disruption in 
                the United States with such research conducted in other 
                nations; and
                    ``(E) report to the public every 2 years on the 
                extent to which hormone disruption by chemicals in the 
                environment poses a threat to human health and the 
                environment.
            ``(2) Issues to be studied.--The program, established under 
        paragraph (1) shall provide for the following:
                    ``(A) Collection, compilation, publication, and 
                dissemination of scientifically valid information on--
                            ``(i) possible human health effects of 
                        hormone disrupting chemicals, with emphasis on 
                        exposures to low doses of individual chemicals 
                        and chemical mixtures during critical life 
                        stages of development, particularly effects of 
                        prenatal exposures on children's health;
                            ``(ii) the extent of human exposure to 
                        hormone disrupting chemicals, with particular 
                        emphasis on exposures during critical life 
                        stages of development and in residential and 
                        occupational settings; and
                            ``(iii) exposure of wildlife species to 
                        hormone disrupting chemicals and possible 
                        health effects associated with such exposures.
                    ``(B) Research on mechanisms by which hormone 
                disrupting substances interact with biological systems.
                    ``(C) Research on improved in vitro and in vivo 
                methods to screen and test hormone disruption.
                    ``(D) Research on the identity, levels, transport 
                and fate of hormone disrupting chemicals in the 
                environment.
    ``(b) Director's Duties.--
            ``(1) In general.--The Director of the Institute shall have 
        principal responsibility, in consultation with the Director of 
        the USGS, for conducting and coordinating research on the 
        effects of hormone disrupting chemicals on human health and the 
        environment.
            ``(2) Agreement.--Not later than 6 months after the date of 
        enactment of the Hormone Disruption Research Act of 2002, the 
        Director of the Institute and the Director of the USGS shall 
        enter into an agreement to carry out the research program 
        established under subsection (a).
            ``(3) Transfer of funds.--The Director of the Institute may 
        transfer funds to other Federal agencies to carry out the 
        Director's responsibilities under paragraph (1).
            ``(4) Report.--The Director of the Institute, in 
        consultation with the Director of the USGS, shall make 
        available to the public, every 2 years following the date of 
        enactment of the Hormone Disruption Research Act of 2002, 
        findings and conclusions on the extent to which hormone 
        disruption by chemicals in the environment poses a threat to 
        human health and the environment.
    ``(c) Interagency Commission.--
            ``(1) Establishment.--The Secretary shall establish a 
        commission to be known as the Hormone Disruption Research 
        Interagency Commission (referred to in this section as 
        `Interagency Commission') to advise the Director of the 
        Institute and the Director of the USGS on the development of a 
        comprehensive agenda for conducting research on hormone 
        disruption.
            ``(2) Membership.--The Interagency Commission shall be 
        composed of 12 members, as follows:
                    ``(A) The Director of the Institute, who shall 
                serve as the Chairperson.
                    ``(B) The Director of the USGS, who shall serve as 
                the Vice-Chairperson.
                    ``(C) The Commissioner of the Food and Drug 
                Administration.
                    ``(D) The Director of the Centers for Disease 
                Control and Prevention.
                    ``(E) The Administrator of the National Oceanic and 
                Atmospheric Administration.
                    ``(F) The Director of the National Institute for 
                Occupational Safety and Health.
                    ``(G) The Administrator of the Agency for Toxic 
                Substances and Disease Registry.
                    ``(H) The Director of the Fish and Wildlife 
                Service.
                    ``(I) The Secretary of Defense.
                    ``(J) The Administrator of the Environmental 
                Protection Agency.
                    ``(K) The Chairman of the Consumer Product Safety 
                Commission.
                    ``(L) The Director of the National Science 
                Foundation.
            ``(3) Staff.--Each department or agency represented by a 
        member on the Interagency Commission shall provide appropriate 
        staff to carry out the duties of the Interagency Commission.
            ``(4) Recommendations.--Not later than 12 months after the 
        date of enactment of the Hormone Disruption Research Act of 
        2002, the Interagency Commission shall recommend to the 
        Director of the Institute and the Director of the USGS a 
        research program, including levels of funding for intramural 
        and extramural research.
            ``(5) Public comment.--The Director of the Institute, 
        through publication of notice in the Federal Register, shall 
        provide the general public with an opportunity to comment on 
        the recommendations of the Interagency Commission.
            ``(6) Report.--Not later than 4 years after the date of 
        enactment of the Hormone Disruption Research Act of 2002, the 
        Interagency Commission shall conduct a review of the program 
        established under subsection (a) and submit a report on the 
        results of such review to the Director of the Institute and to 
        the Hormone Disruption Research Panel established under 
        subsection (e).
    ``(d) Financial Assistance.--
            ``(1) In general.--The Director of the Institute may 
        provide financial assistance and enter into grants, contracts, 
        and interagency memoranda of understanding to conduct 
        activities under this section. Research conducted pursuant to 
        interagency memoranda of understanding may be conducted through 
        intramural and extramural agency research programs, subject to 
        appropriate scientific peer review.
    ``(e) Hormone Disruption Research Panel.--
            ``(1) Establishment.--There is established in the Institute 
        a Hormone Disruption Research Panel (referred to in this 
        subsection as the `Panel').
            ``(2) Duties.--The Panel shall advise the Director of the 
        Institute concerning the scientific content of the program 
        established under subsection (a), the progress of such program, 
        and public outreach, and shall provide such other advice as 
        requested by the Director of the Institute.
            ``(3) Membership.--The Panel shall be composed of the 
        following:
                    ``(A) 15 voting members to be appointed by the 
                President, in consultation with the Director of the 
                Institute.
                    ``(B) Such nonvoting, ex officio members as the 
                Director of the Institute determines to be appropriate.
            ``(4) Voting members.--Of the 15 voting members of the 
        Panel--
                    ``(A) at least 2 members shall be from 
                environmental protection organizations;
                    ``(B) at least 2 members shall be from public 
                health and consumer organizations;
                    ``(C) at least 2 members shall be from industry; 
                and
                    ``(D) a majority of the members shall be selected 
                from among scientists and environmental health 
                professionals who--
                            ``(i) are not officers or employees of the 
                        United States;
                            ``(ii) represent multiple disciplines, 
                        including clinical, basic, public, and 
                        ecological health sciences;
                            ``(iii) represent different geographical 
                        regions of the United States;
                            ``(iv) are from practice settings, academic 
                        settings, and for-profit or not-for-profit 
                        research settings; and
                                    ``(v) have experience in review of 
                                research on endocrine disruption.
            ``(5) Terms.--The members of the Panel shall be appointed 
        for an initial term of 3 years and shall be eligible for 
        reappointment for 1 additional term of 2 years.
            ``(6) Chairperson.--The members of the Panel appointed 
        under paragraph (3) shall elect a chairperson from among such 
        members.
            ``(7) Meetings.--The Panel shall meet at the call of the 
        chairperson or upon the request of the Director of the 
        Institute, but in no case less often than once each year.
            ``(8) Administrative support.--The Institute shall provide 
        administrative support to the Panel.
    ``(f) Conflicts of Interest.--All grants and contracts entered into 
under this section shall include conflict of interest provisions that 
require any person conducting a project under this section to disclose 
any other source of funding received by the person to conduct other 
related projects.
    ``(g) Definitions.--For purposes of this section:
            ``(1) Hormone.--The term `hormone' means a substance 
        produced in a cell or tissue that triggers a biological 
        response. Hormone activity may be localized to the cell in 
        which the substance is produced, or may be in nearby or distant 
        tissues or organs.
            ``(2) Hormone disruption.--The term `hormone disruption' 
        means interference by a substance with the synthesis, 
        secretion, transport, binding, action, or elimination of 
        natural hormones in the body that are responsible for the 
        maintenance of homeostasis, reproduction, development, 
        function, or behavior.
    ``(h) Authorization of Appropriations.--
            ``(1) General authorization.--There are authorized to be 
        appropriated $500,000,000 for the 5-fiscal-year period 
        beginning with fiscal year 2003 to carry out this section. 
        Amounts appropriated pursuant to this paragraph shall remain 
        available until expended.
            ``(2) Restrictions on use of funds.--
                    ``(A) Construction and rehabilitation of facilities 
                and equipment.--Not more than 0.5 percent of the funds 
                made available under this section may be used for the 
                construction or rehabilitation of facilities or fixed 
                equipment.
                    ``(B) Administrative expenses of the director.--Of 
                the total amount of funds made available under this 
                section for any fiscal year, not more than 2 percent of 
                such funds may be used for administrative expenses of 
                the Director of the Institute in carrying out this 
                section.
                    ``(C) Public outreach.--Of the total amount of 
                funds made available under this section for any fiscal 
                year, at least 1 percent, but not more than 5 percent, 
                shall be used for outreach to the public concerning the 
                activities and results of the program.''.
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