To authorize the National Institute of Environmental Health Sciences to develop multidisciplinary research centers regarding women's health and disease prevention and conduct and coordinate a research program on hormone disruption, and for other purposes.

February 13, 2003

Ms. SLAUGHTER (for herself and Mr. WAXMAN) 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

To authorize the National Institute of Environmental Health Sciences to develop multidisciplinary research centers regarding women's health and disease prevention and 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 Health Research Act of 2003'.

SEC. 2. NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES; AWARDS FOR DEVELOPMENT AND OPERATION OF MULTIDISCIPLINARY RESEARCH CENTERS REGARDING WOMEN'S HEALTH AND DISEASE PREVENTION.

Subpart 12 of part C of title IV of the Public Health Service Act (42 U.S.C. 285l et seq.) is amended by adding at the end the following section:

`MULTIDISCIPLINARY RESEARCH CENTERS REGARDING WOMEN'S HEALTH AND DISEASE PREVENTION

`SEC. 463B. (a) IN GENERAL- The Director of the Institute shall make grants to public or nonprofit private entities for the development and operation of not more than 6 centers whose purpose is conducting multidisciplinary research on environmental factors that may be related to the development of women's health conditions (as defined in section 486). The Director of the Institute shall carry out this section in consultation with the Director of the Office of Research on Women's Health and with the advisory council for the Institute.

`(b) RESEARCH, TRAINING, AND INFORMATION AND EDUCATION-

`(1) IN GENERAL- Each center under subsection (a) shall, with respect to the purpose described in such subsection--

`(A) conduct basic and clinical research;

`(B) develop protocols for training physicians, scientists, nurses, and other health and allied health professionals;

`(C) conduct training programs for such individuals;

`(D) develop model continuing education programs for such professionals; and

`(E) disseminate information to such professionals and the public.

`(2) PRIORITY FOR PREVENTION ACTIVITIES- In carrying out the activities described in paragraph (1), each center under subsection (a) shall give priority to activities that are directed toward preventing the development in women of the diseases and conditions involved.

`(3) STIPENDS FOR TRAINING OF HEALTH PROFESSIONALS- A center under subsection (a) may use funds under such subsection to provide stipends for health and allied health professionals enrolled in programs described in paragraph (1)(C).

`(c) COLLABORATION WITH COMMUNITY- Each center under subsection (a) shall establish and maintain ongoing collaborations with community organizations in the geographic area served by the center, including those that represent women with disorders that appear to stem from environmental factors.

`(d) COORDINATION OF CENTERS; REPORTS- The Director of the Institute shall, as appropriate, provide for the coordination of information among centers under subsection (a) and ensure regular communication between such centers.

`(e) STRUCTURE OF CENTER- Each center assisted under subsection (a) shall use the facilities of a single institution, or be formed from a consortium of cooperating institutions, meeting such requirements as may be prescribed by the Director of the Institute.

`(f) DURATION OF SUPPORT- Support of a center under subsection (a) may be for a period not exceeding 5 years. Such period may be extended for 1 or more additional periods not exceeding 5 years if the operations of such center have been reviewed by an appropriate technical and scientific peer review group established by the Director of the Institute and if such group has recommended to the Director that such period should be extended.

`(g) AUTHORIZATION OF APPROPRIATIONS- For the purpose of carrying out this section, there are authorized to be appropriated such sums as may be necessary for fiscal years 2004 through 2007.'.

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

(a) 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. 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) 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.

(14) 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.

(15) 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.

(b) AMENDMENT- Subpart 12 of part C of title IV of the Public Health Service Act (42 U.S.C. 2851 et seq.), as amended by section 2, is further amended by adding at the end the following:

`DIRECTED NATIONAL PROGRAM OF RESEARCH ON HORMONE DISRUPTION

`SEC. 463C. (a) RESEARCH-

`(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 multiagency 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- 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 Environmental Health Research Act of 2003, 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 Environmental Health Research Act of 2003, 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 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 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 Environmental Health Research Act of 2003, 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 Environmental Health Research Act of 2003, 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 (h)(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 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;

`(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; 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.

`(9) TERMINATION- The Panel shall terminate not later than the end of the 5-year fiscal period described in subsection (h)(1).

`(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 such sums as may be necessary for the 5-fiscal-year period beginning with fiscal year 2004 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.'.

END