[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5809 Introduced in House (IH)]







110th CONGRESS
  2d Session
                                H. R. 5809

   To amend the Public Health Service Act to authorize the National 
Institute of Environmental Health Sciences to conduct and coordinate a 
    research program on hormone disruption, and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                             April 15, 2008

 Ms. Slaughter (for herself, Mr. Blumenauer, Mrs. Capps, Mr. Conyers, 
 Mr. Ellison, Mr. Grijalva, Mr. Hinchey, Ms. Jackson-Lee of Texas, Ms. 
McCollum of Minnesota, Mr. McGovern, Mr. McNulty, Mr. George Miller of 
California, Mr. Moran of Virginia, Mr. Van Hollen, Mr. Waxman, and Mr. 
    Honda) introduced the following bill; which was referred to the 
Committee on Energy and Commerce, and in addition to the Committees on 
   Natural Resources and Science and Technology, 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 Service Act to authorize the National 
Institute of Environmental Health Sciences to conduct and coordinate a 
    research program on hormone disruption, 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 ``Environmental Hormone Disruption 
Research Act of 2008''.

SEC. 2. FINDINGS.

    The Congress finds as follows:
            (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 and metabolism. Few standardized and 
        validated screens or tests have been developed to routinely and 
        systematically assess chemicals for disruptive effects on 
        hormone systems. Even fewer have statistical power to detect 
        sufficient problems.
            (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 disorder and attention deficit 
        hyperactivity disorder, autism, thyroid disorders, learning 
        disabilities, cognitive impairment, and auto-immune disorders. 
        Exposure to hormone-disrupting pollutants 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 disrupted reproduction 
        or development, including birds, fish, amphibians, and mammals. 
        The effects vary among species, and some are due to exposure to 
        hormone-disrupting substances.
            (5) Observed disruptions 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. If due to exposure to hormone-
        disrupting substances, then these effects may signal hazards to 
        human health.
            (6) Laboratory studies have corroborated studies of some 
        effects in wildlife and have identified biological mechanisms 
        to explain the effects shown. The chemicals found in wildlife 
        are also found in humans.
            (7) Hormone disruption might occur at very low 
        environmental doses, especially when exposure occurs in the 
        womb or immediately after birth, periods during which rapid 
        development is occurring.
            (8) 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''.
            (9) 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.
            (10) 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.
            (11) While recognizing the many contributions of animal 
        testing to understanding toxic hazards, the Congress also 
        recognizes the desirability of speeding the use of validated 
        nonanimal screens and tests (to reduce animal suffering and to 
        reduce costs) and expediting judgments about hazards from toxic 
        chemicals.
            (12) The Department of the Interior 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 Department of the 
        Nation's water resources and wildlife disease, and research by 
        the Department on the effects of chemicals on wildlife.
            (13) The National Academy of Sciences has recognized the 
        expertise of the United States Geological Survey (``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. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES; DIRECTED 
              NATIONAL PROGRAM OF 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 the following:

``SEC. 463C. DIRECTED NATIONAL PROGRAM OF RESEARCH ON HORMONE 
              DISRUPTION.

    ``(a) Research.--
            ``(1) In general.--The Director of the Institute shall 
        establish within the Institute a comprehensive program to--
                    ``(A) carry out research on the health effects on 
                women and children that may result through disruption 
                of the hormone systems;
                    ``(B) carry out research, development, and 
                demonstrations with respect to technologies to mitigate 
                the occurrence of hormone-disrupting pollutants in the 
                environment and their unintended effects on ecological 
                and wildlife health, in cooperation with the United 
                States Geological Survey (referred to in this section 
                as the `USGS');
                    ``(C) coordinate research on hormone disruption in 
                the United States with such research conducted in other 
                nations; and
                    ``(D) provide for the dissemination of information 
                described in paragraph (2) to the public.
            ``(2) Issues.--The program established under paragraph (1) 
        shall provide for the following:
                    ``(A) Collection, compilation, publication, and 
                dissemination of scientifically valid information on--
                            ``(i) possible unintended human health 
                        effects of hormone-disrupting pollutants, 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 pollutants, 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 pollutants and possible 
                        health effects associated with such exposures.
                    ``(B) Research, in coordination with the 
                Environmental Protection Agency and the USGS, on 
                mechanisms by which hormone-disrupting pollutants 
                interact with biological systems.
                    ``(C) Research on improved in vitro, in vivo, and 
                in silico methods to screen and test hormone 
                disruption.
                    ``(D) Research on the identity, levels, transport, 
                and fate of hormone-disrupting pollutants 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 
        unintended effects of hormone-disrupting pollutants on human 
        health and the environment.
            ``(2) Agreement.--Not later than 6 months after the date of 
        the enactment of the Environmental Hormone Disruption Research 
        Act of 2008, 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 
        the enactment of the Environmental Hormone Disruption Research 
        Act of 2008, a report summarizing findings and conclusions on 
        the extent to which hormone disruption by pollutants 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 the 
        `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 14 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 Director of the National Institute of 
                Child Health and Human Development.
                    ``(D) The Commissioner of Food and Drugs.
                    ``(E) The Director of the Centers for Disease 
                Control and Prevention.
                    ``(F) The Administrator of the National Oceanic and 
                Atmospheric Administration.
                    ``(G) The Director of the National Institute for 
                Occupational Safety and Health.
                    ``(H) The Administrator of the Agency for Toxic 
                Substances and Disease Registry.
                    ``(I) The Director of the Fish and Wildlife 
                Service.
                    ``(J) The Secretary of Defense.
                    ``(K) The Administrator of the Environmental 
                Protection Agency.
                    ``(L) The Chairman of the Consumer Product Safety 
                Commission.
                    ``(M) The Director of the National Science 
                Foundation.
                    ``(N) The Director of the National Institute of 
                Neurological Disorders and Stroke.
            ``(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 the enactment of the Environmental Hormone Disruption 
        Research Act of 2008, 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 the 
        enactment of the Environmental Hormone Disruption Research Act 
        of 2008, 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).
            ``(7) Termination.--The Interagency Commission shall 
        terminate not later than the end of the 5-year fiscal period 
        described in subsection (j)(1).
    ``(d) Financial Assistance.--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 make recommendations to the 
        Interagency Commission with respect to the duties of the 
        Interagency Commission under subsection (c)(1) and advise the 
        Secretary and the Director of the Institute with respect to the 
        design and implementation of the program under subsection (a), 
        including preparation of solicitations for proposals to conduct 
        research under the program.
            ``(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 but not more than 7 shall 
                be from industry;
                    ``(D) at least 1 member shall be from an animal 
                welfare organization; and
                    ``(E) 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;
                            ``(v) have experience in review of research 
                        on endocrine disruption; and
                            ``(vi) possess a relevant advanced degree 
                        from an accredited college or university.
            ``(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.
            ``(9) Termination.--The Panel shall terminate not later 
        than the end of the 5-year fiscal period described in 
        subsection (j)(1).
    ``(f) Solicitation and Selection of Proposals.--
            ``(1) In general.--Within 15 months after the date of the 
        enactment of the Environmental Hormone Disruption Research Act 
        of 2008, and as often thereafter as appropriate, the Director 
        of the Institute shall, in consultation with the Interagency 
        Commission, solicit and select proposals to conduct activities 
        under the program under subsection (a).
            ``(2) Consultation with panel.--In preparing solicitations 
        for such proposals, the Director of the Institute shall consult 
        with the Hormone Disruption Research Panel.
            ``(3) Peer review panels.--Before a proposal to conduct 
        activities under the program under subsection (a) may be 
        selected by the Director of the Institute, such proposal shall 
        be submitted to, and evaluated by, at least one scientific and 
        technical peer review panel.
    ``(g) Reports.--
            ``(1) Report upon completion of activity.--Any person who 
        conducts activities under the program under subsection (a) 
        shall, upon completion of the activity, submit to the National 
        Academy of Sciences, the Interagency Commission, and the 
        Hormone Disruption Research Panel a report summarizing the 
        activities and results thereof.
            ``(2) Report to interagency commission and panel.--The 
        Director of the Institute shall enter into appropriate 
        arrangements with the National Academy of Sciences under which 
        the Academy shall periodically submit to the Interagency 
        Commission and the Hormone Disruption Research Panel a report 
        that evaluates the research activities under the program under 
        subsection (a). The report shall include recommendations to 
        promote the effective transfer of information derived from such 
        research activities. The Director of the Institute shall be 
        responsible for expenses incurred by the Academy in connection 
        with the preparation of such reports.
            ``(3) Report to congress.--The Interagency Commission, in 
        consultation with the Hormone Disruption Research Panel, shall 
        submit to the Secretary and the Congress--
                    ``(A) not later than December 31, 2011, a report 
                summarizing the progress of the research program under 
                subsection (a); and
                    ``(B) not later than September 30, 2014, a final 
                report stating the Interagency Commission's findings 
                and conclusions on the effects, if any, of hormone-
                disrupting pollutants in the environment on human 
                health and remedial actions, if any, that may be needed 
                to minimize any such health effects.
    ``(h) 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.
    ``(i) 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-disrupting.--The term `hormone-disrupting' 
        means producing effects similar to those of naturally occurring 
        hormones or interfering with hormone signaling or hormone 
        interaction with receptors.
            ``(3) Hormone disruption.--The term `hormone disruption' 
        means interference 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.
    ``(j) Authorization of Appropriations.--
            ``(1) General authorization.--There are authorized to be 
        appropriated such sums as may be necessary for the 5-fiscal-
        year period beginning with fiscal year 2009 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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