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.

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:

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 2009, 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 2009, 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 2009, 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 2009, 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 2009, 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, 2013, a report summarizing the progress of the research program under subsection (a); and (B)not later than September 30, 2016, 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 2011 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.