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[Congressional Bills 111th Congress]
[From the U.S. Government Publishing Office]
[H.R. 4190 Introduced in House (IH)]

111th CONGRESS
  1st Session
                                H. R. 4190

   To amend the Public Health Service Act to authorize the National 
   Institute of Environmental Health Sciences to conduct a research 
 program on endocrine disruption, to prevent and reduce the production 
 of, and exposure to, chemicals that can undermine the development of 
 children before they are born and cause lifelong impairment to their 
              health and function, and for other purposes.

_______________________________________________________________________

                    IN THE HOUSE OF REPRESENTATIVES

                            December 3, 2009

 Mr. Moran of Virginia (for himself, Mrs. Lowey, Mr. George Miller of 
California, Ms. McCollum, Mr. Grijalva, Mr. McGovern, Mr. Hinchey, and 
 Mr. Kennedy) introduced the following bill; which was referred to the 
                    Committee on Energy and Commerce

_______________________________________________________________________

                                 A BILL

 
   To amend the Public Health Service Act to authorize the National 
   Institute of Environmental Health Sciences to conduct a research 
 program on endocrine disruption, to prevent and reduce the production 
 of, and exposure to, chemicals that can undermine the development of 
 children before they are born and cause lifelong impairment to their 
              health and function, 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 Disruption Prevention Act 
of 2009''.

SEC. 2. FINDINGS, POLICIES, AND GOALS.

    (a) Findings.--The Congress finds that--
            (1) a disturbing increase in the number of disorders of the 
        human endocrine system is seriously undermining the health and 
        wealth of the Nation;
            (2) these disorders include attention deficit hyperactivity 
        disorder (ADHD), autism, learning disabilities, asthma, 
        juvenile cancer, juvenile and adult diabetes, autoimmune 
        diseases, cryptorchidism, hypospadias, endometriosis, obesity, 
        osteoporosis, testicular cancer, male dysgenesis syndrome, 
        breast cancer, prostate cancer, Parkinson's disease, and 
        Alzheimer's dementia;
            (3) these disorders began to increase noticeably at the 
        population level in the early 1970s when the first generation 
        exposed in the womb to post-World War II synthetic chemicals 
        reached maturity;
            (4) prior to 1950, these disorders were rare, which rules 
        out the influence of inherited disorders;
            (5) today, among the fourth generation of children exposed 
        in the womb, one in three children and one in two minority 
        children will develop diabetes; one in six children is born 
        with neurological damage; one in 100 children has an autism 
        spectrum disorder and among boys the occurrence is one in 58; 
        one in 125 boys is born with hypospadias, a condition where the 
        urethra does not open at the end of the penis; in 2007, an age-
        independent decline in testosterone levels over the past twenty 
        years was discovered in American men; and declines in male 
        reproductive health have been traced back to damage in the 
        womb;
            (6) evidence from human epidemiological and laboratory 
        animal studies links these disorders to prenatal and later life 
        exposure to endocrine disrupting chemicals (EDCs);
            (7) the endocrine system is a complex system of organs 
        regulated by over eighty known hormones as well as hundreds of 
        auxiliary chemical signaling systems, and it assures the 
        perpetuity and integrity of human life;
            (8) recent bio-monitoring demonstrates that embryos, 
        fetuses, infants, and children in the United States carry 
        hundreds of synthetic chemicals in their blood and tissue, 
        including EDCs, and similar results have been found for adults;
            (9) thousands of chemicals have become an integral part of 
        confined environments (homes, schools, cars, planes, offices, 
        theaters, malls), contributing to continual, ubiquitous 
        exposure, and it is vital to be able to identify which are 
        EDCs;
            (10) many plant and animal species are showing signs of ill 
        health due to exposure to endocrine disrupting chemicals, which 
        can cause small, but critical, changes in the chemical makeup 
        of an environment that are enough to trigger outcomes that 
        could lead to population decline and loss of biodiversity;
            (11) one out of five male black bass in nine river basins 
        across the United States exhibit intersex organs and up to 100 
        percent of smallmouth bass at some sites in the Potomac River 
        basin during spawning season exhibit the same organ changes, 
        which scientists say suggests they have been exposed to EDCs;
            (12) all vertebrates (fish, amphibians, reptiles, birds, 
        and mammals, including humans) are fundamentally similar during 
        early embryonic development, so scientists can use the evidence 
        acquired on other species to make predictions about endocrine 
        disrupting effects on humans;
            (13) traditional toxicology and risk assessment, which 
        evaluate one chemical at a time, and only at high 
        concentrations, have failed to sufficiently address the effects 
        of low doses of chemicals at multiple early life stages and 
        have not prevented the alarming increase of endocrine disorders 
        sweeping across the Northern Hemisphere;
            (14) since the early 1990s, independent government-funded 
        scientists in academic and institutional laboratories around 
        the world have published data demonstrating the ability of a 
        broad selection of chemicals to interfere with human 
        development and function by affecting a number of endocrine 
        mechanisms, and have discovered endocrine disruptive effects 
        for some widely used chemicals at concentrations several 
        thousand times lower than government ``safe'' levels derived 
        through traditional toxicological tests;
            (15) these scientists have developed a new paradigm for 
        disease, the developmental basis of disease, which states that 
        disease starts during development and is influenced by 
        exposures to environmental chemicals, stress and nutrition 
        interacting on the developing organism;
            (16) the developmental basis of disease changes the focus 
        from curing disease to prevention and to understanding gene-
        environment-nutrition interactions during development;
            (17) the National Institute of Environmental Health 
        Sciences (NIEHS) and the National Toxicology Program (NTP) have 
        conducted important studies on the environmental connection to 
        human diseases, and have in place a 5-tier scale of concern by 
        which to evaluate chemicals based on the weight of scientific 
        evidence and toxicity and exposure information;
            (18) while research has established that exposure to EDCs 
        induces delayed toxicity that results in disease weeks, months, 
        years, or decades later in life, Federal regulatory agencies 
        generally are not using the results of this research to 
        restrict production and use of even the most egregious 
        chemicals;
            (19) although Congress directed the Environmental 
        Protection Agency in the Food Quality Protection Act of 1996 to 
        develop, not later than August 3, 1998, ``a screening program 
        using appropriate validated test systems and other 
        scientifically relevant information, to determine whether 
        certain substances may have an effect in humans that is similar 
        to an effect produced by a naturally occurring estrogen, or 
        such other endocrine effect as the Administrator may 
        designate'', the Agency did not release test orders announcing 
        the availability of initial standardized screens and testing 
        protocols until October 21, 2009, and no chemical has been 
        tested for its impact on development and function from 
        fertilization to birth, despite the expenditure of more than 
        $100,000,000;
            (20) given these delays and the alarming trends in 
        endocrine-related disorders, the United States must 
        expeditiously take preventive action based on an entirely new 
        approach to reducing children's exposure before birth to EDCs; 
        and
            (21) the costs to society of not taking action include 
        medical expenses of treating these chronic diseases, lost 
        productivity, impaired fertility, compromised quality of life 
        for those affected, their families and communities, so 
        prevention is the key.
    (b) Policies and Goals.--It is the policy of the United States--
            (1) to promote family health and the perpetuation of the 
        human species as a paramount national goal, recognizing that in 
        order to protect the embryo, fetus, and infant during their 
        most vulnerable stages of development, parents' bodies must be 
        free of EDCs prior to conception, during gestation, and 
        throughout lactation;
            (2) to prevent harmful exposure to EDCs in homes, 
        workplaces, schools, public and private transportation 
        vehicles, indoor and outdoor recreational environments, and in 
        drinking water, foods, and consumer products;
            (3) to develop scientific support for Federal public health 
        strategies based on the entire body of peer-reviewed public 
        literature in an environment that is free from conflicts of 
        interest;
            (4) to promote research into endocrine disruption by 
        encouraging the multidisciplinary, multi-institutional, and 
        international collaborations that in the past have produced 
        many breakthroughs in knowledge;
            (5) to create graduate-level scholarships and post-doctoral 
        fellowships to train young scientists who can meet the demand 
        for technicians and public health and health care personnel in 
        endocrine disruption prevention;
            (6) to determine which chemicals in commerce have the 
        potential to disrupt the human endocrine system and to remove 
        these chemicals, and products containing them, from the market; 
        and
            (7) to prevent the introduction of new chemicals, and 
        products containing them, that have the potential to disrupt 
        the human endocrine system by requiring testing for these 
        effects before these chemicals and products are released on the 
        market.

SEC. 3. ENDOCRINE DISRUPTION PREVENTION PROGRAM.

    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. ENDOCRINE DISRUPTION PREVENTION.

    ``(a) Program.--The Director of the National Institute of 
Environmental Health Sciences shall establish a program, to be known as 
the Endocrine Disruption Prevention Program, consisting of research, 
workshops, and fora under subsection (b).
    ``(b) Research, Workshops, and Fora.--
            ``(1) Research.--The Director of the Institute shall 
        conduct and support multidisciplinary research, to improve the 
        understanding of endocrine disruption. Such research shall--
                    ``(A) include research to design and develop 
                sensitive tests to screen chemicals using assays that 
                are effective for identifying chemicals with the 
                potential to disrupt the human endocrine system;
                    ``(B) address the full range of possible health 
                outcomes, including--
                            ``(i) male and female developmental and 
                        reproductive disorders;
                            ``(ii) brain (behavioral and intellectual) 
                        disorders;
                            ``(iii) metabolic syndrome, pre-diabetes, 
                        diabetes, improper glucose and fat metabolism, 
                        obesity, and cardiovascular disorders;
                            ``(iv) effects on the pituitary, 
                        hypothalamus, hippocampus, thyroid, adrenal, 
                        immune, bone, cardiovascular, and other 
                        endocrine organs and systems throughout all 
                        life stages;
                            ``(v) hormonally driven cancer; and
                            ``(vi) other related effects;
                    ``(C) be appropriately sensitive to detect a 
                chemical's potential to disrupt the human endocrine 
                system at ambient exposure dosing levels;
                    ``(D) consider the potential for additive and 
                synergistic effects and need not be based solely on 
                expectations of monotonic effects where the dose 
                reflects the toxicity;
                    ``(E) be carried out using a multidisciplinary 
                approach to assure connections among multiple levels, 
                from molecular to organ to whole animal or human 
                research; and
                    ``(F) be designed to develop 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.
            ``(2) Workshops and fora.--
                    ``(A) In general.--The Director of the Institute 
                shall conduct workshops and fora on the health effects 
                associated with environmental agents that may affect 
                the endocrine system in order to--
                            ``(i) identify new chemicals of concern for 
                        research under paragraph (1);
                            ``(ii) strategize on approaches for the 
                        development of sensitive tests to screen 
                        chemicals for endocrine disrupting activity 
                        using assays;
                            ``(iii) review the state of the science and 
                        provide recommendations for a research, 
                        testing, and training agenda; and
                            ``(iv) educate attendees about endocrine 
                        disrupting chemicals.
                    ``(B) Workshops.--
                            ``(i) First workshop.--The Director of the 
                        Institute shall invite the Secretary of the 
                        Interior, the Administrator of the 
                        Environmental Protection Agency, and the 
                        Director of the Centers for Disease Control and 
                        Prevention to participate in a workshop under 
                        subparagraph (A) not later than 150 days after 
                        the date of the enactment of this section.
                            ``(ii) Subsequent workshops.--The Director 
                        of the Institute shall convene subsequent 
                        workshops under subparagraph (A) as the 
                        Director determines appropriate.
                            ``(iii) Participants.--The Director of the 
                        Institute shall--
                                    ``(I) invite additional 
                                participants to each workshop under 
                                subparagraph (A);
                                    ``(II) in selecting such 
                                participants, include scientists and 
                                health professionals who are 
                                knowledgeable about the endocrine 
                                system and environmental exposures that 
                                may influence the endocrine system;
                                    ``(III) select as participants only 
                                those individuals who the Director 
                                determines will participate in a manner 
                                free of conflicts of interest; and
                                    ``(IV) in addition to the 
                                participants invited under subclause 
                                (I), allow representatives of 
                                nongovernmental organizations to attend 
                                each workshop under subparagraph (A) as 
                                observers.
                    ``(C) Fora.--At least every 3 years, the Director 
                of the Institute shall convene an open forum for all 
                stakeholders--
                            ``(i) to review the state of the science 
                        relevant to environmental agents that influence 
                        the endocrine system; and
                            ``(ii) to discuss the future direction of 
                        the Endocrine Disruption Prevention Program.
    ``(c) Expert Panel.--
            ``(1) Establishment.--The Director of the Institute shall 
        establish an Endocrine Disruption Program Panel (in this 
        section referred to as the `Panel') not later than one year 
        after the date of the enactment of this section.
            ``(2) Members.--The Director of the Institute shall appoint 
        the members of the Panel from among individuals who--
                    ``(A) have established expertise in the field of 
                endocrine disruption research by publishing research in 
                peer-reviewed literature;
                    ``(B) provide assurances they will perform their 
                duties 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
                    ``(C) represent diverse disciplines, including 
                developmental biology, endocrinology, developmental and 
                neurological biology, embryology, biochemistry, 
                physiology, epidemiology, endocrine driven oncology, 
                and medical research.
            ``(3) Duties.--The Panel shall--
                    ``(A) provide advice to the Director of the 
                Institute on the conduct and support of research under 
                subsection (b);
                    ``(B) evaluate existing population-level 
                biomonitoring and biobanking surveillance and research 
                programs and recommend changes needed to develop data 
                on human exposures and effects to support the Endocrine 
                Disruption Prevention Program; and
                    ``(C) develop a list of chemicals of concern for 
                endocrine disruption effects and make findings with 
                respect to such chemicals in accordance with paragraph 
                (4).
            ``(4) Chemicals of concern.--
                    ``(A) List.--The Panel shall--
                            ``(i) develop a list of chemicals of 
                        concern for endocrine disruption effects; and
                            ``(ii) update such list annually.
                    ``(B) Qualitative evaluation system.--The Panel 
                shall create a tiered qualitative evaluation system, 
                modeled after that of the National Toxicology Program, 
                in order to express the Panel's level of concern that a 
                chemical on the list under subparagraph (A) has the 
                potential to disrupt the human endocrine system.
                    ``(C) Required findings.--For each chemical 
                identified in the list under subparagraph (A), the 
                Panel shall review peer-reviewed studies and other 
                relevant data and issue a finding, based on all of the 
                available evidence, regarding--
                            ``(i) the level of the Panel's concern, 
                        under the tiered qualitative evaluation system, 
                        that the chemical has the potential to disrupt 
                        the human endocrine system;
                            ``(ii) the need for additional data to 
                        determine the level of concern associated with 
                        the chemical's potential to disrupt the human 
                        endocrine system; or
                            ``(iii) the need for assays to be developed 
                        to provide the data necessary to support a 
                        determination as to the level of concern 
                        associated with the chemical's potential to 
                        disrupt the human endocrine system.
                    ``(D) Sufficient data.--If the Panel finds under 
                subparagraph (C)(i) that data are sufficient to 
                determine the extent to which a chemical has the 
                potential to disrupt the human endocrine system, the 
                Panel shall publish an explanation of this 
                determination and include the supporting data.
                    ``(E) Minimal level of concern.--If the Panel finds 
                under subparagraph (C)(i) that data are sufficient to 
                determine (under the tiered qualitative evaluation 
                system established under subparagraph (B)) that there 
                is at least a minimal level of concern associated with 
                a chemical's potential to disrupt the human endocrine 
                system, the Panel shall describe the routes and sources 
                of exposure to the chemical that may cause effects to 
                human health.
                    ``(F) Additional data needed.--If the Panel finds 
                under subparagraph (C)(ii) that additional data are 
                needed to determine the level of concern associated 
                with the chemical's potential to disrupt the human 
                endocrine system, the Panel shall--
                            ``(i) identify such data; and
                            ``(ii) recommend a process for developing 
                        such data directly or by grant or contract.
                    ``(G) Assays needed.--If the Panel finds under 
                subparagraph (C)(iii) that assays need to be developed 
                to provide the data necessary to support a 
                determination as to the level of concern associated 
                with the chemical's potential to disrupt the human 
                endocrine system, the Panel shall identify such assays 
                to the extent possible.
                    ``(H) Annual report.--The Panel shall submit to the 
                Director of the Institute and to the Congress an annual 
                report on the Panel's activities. Each such report 
                shall include--
                            ``(i) an updated version of the list 
                        developed under subparagraph (A); and
                            ``(ii) for each chemical on the list, the 
                        findings and recommendations of the Panel under 
                        subparagraphs (D) through (G).
                    ``(I) No judicial review.--A finding or other 
                determination of the Panel under this paragraph shall 
                not be subject to judicial review, nor to correction 
                under section 515 of the Treasury and General 
                Government Appropriations Act, 2001 (commonly referred 
                to as the `Information Quality Act').
                    ``(J) Petitions.--
                            ``(i) In general.--Any person may petition 
                        the Panel to determine whether a chemical 
                        should be listed pursuant to subparagraph (A) 
                        or revise a finding or other determination 
                        under this paragraph based on new information.
                            ``(ii) Rules.--The Director shall adopt 
                        rules that provide for--
                                    ``(I) the form and procedure for 
                                filing of petitions under this 
                                subparagraph; and
                                    ``(II) the procedural rights of 
                                persons filing such petitions.
    ``(d) Transmission of Certain Findings to Other Agencies.--
            ``(1) In general.--If the Panel finds under subsection 
        (c)(4)(C)(i) that data are sufficient to determine (under the 
        tiered qualitative evaluation system established under 
        subsection (c)(4)(B)) that there is at least a minimal level of 
        concern associated with a chemical's potential to disrupt the 
        human endocrine system, the Director of the Institute shall 
        transmit the finding, including the Panel's description of the 
        routes and sources of exposure to the chemical and any other 
        relevant information, to each Federal agency with authority to 
        regulate the chemical or the route or source of human exposure 
        to the chemical.
            ``(2) Public availability.--Whenever the Director of the 
        Institute transmits to one or more agencies a finding under 
        paragraph (1) regarding a chemical, the Director shall publish 
        in the Federal Register the names of the agencies and the 
        chemical.
    ``(e) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated such sums as may be necessary 
for fiscal years 2011 through 2021.''.

SEC. 4. FEDERAL AGENCY ACTION.

    (a) Requirements.--Upon receipt of a transmission under section 
463C(d) of the Public Health Service Act, as added by section 3 of this 
Act, containing a finding that there is at least a minimal level of 
concern associated with a chemical's potential to disrupt the human 
endocrine system, a Federal agency--
            (1) not later than 180 days after the date of such receipt, 
        shall issue a reply in writing to the Director of the National 
        Institute of Environmental Health Sciences (in this Act 
        referred to as the ``Institute'') describing--
                    (A) the agency's authorities in connection with the 
                chemical;
                    (B) any past or ongoing actions taken by the agency 
                in connection with the chemical; and
                    (C) the proposed course of action to be taken by 
                the agency in response to the Panel's finding, 
                including but not limited to further testing by the 
                Institute or the issuance of regulations, orders, or 
                public notices under the agency's existing authorities, 
                in furtherance of protecting human health from the 
                potential endocrine disruption effects of exposure to 
                the chemical; and
            (2) not later than one year after the date of such receipt, 
        shall submit to the Congress and shall publish a report 
        summarizing the actions taken by the agency in response to the 
        Panel's finding, as well as proposed future actions to be taken 
        by the agency.
    (b) No Additional Regulatory Authority.--This section does not vest 
any agency with additional authority to regulate a chemical or the 
route or source of human exposure to a chemical.
    (c) Citizen Suits.--
            (1) Authority to bring civil actions.--Any person may 
        commence a civil action to compel any agency action required by 
        subsection (a).
            (2) Jurisdiction.--The United States courts of appeals 
        shall have exclusive original jurisdiction over such an action.

SEC. 5. TRAINING IN FIELDS RELATED TO THE PREVENTION OF ENDOCRINE 
              DISRUPTION.

    (a) In General.--The Director of the Institute shall establish a 
program to support, directly or by making grants, graduate and 
postdoctoral training in fields related to the prevention of endocrine 
disruption.
    (b) Authorization of Appropriations.--To carry out this section, 
there are authorized to be appropriated $2,500,000 for fiscal year 2011 
and such sums as may be necessary for fiscal years 2012 through 2021.
                                 <all>
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