[Congressional Bills 112th Congress]
[From the U.S. Government Publishing Office]
[H.R. 553 Introduced in House (IH)]

112th CONGRESS
  1st Session
                                H. R. 553

 To amend the Safe Drinking Water Act regarding an endocrine disruptor 
                           screening program.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                            February 8, 2011

   Mr. Markey (for himself, Mr. Grijalva, Mr. Moran, and Ms. Norton) 
 introduced the following bill; which was referred to the Committee on 
                          Energy and Commerce

_______________________________________________________________________

                                 A BILL


 
 To amend the Safe Drinking Water Act regarding an endocrine disruptor 
                           screening program.

    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 Disruptor Screening 
Enhancement Act of 2011''.

SEC. 2. ENDOCRINE DISRUPTOR SCREENING PROGRAM.

    Section 1457 of the Safe Drinking Water Act (42 U.S.C. 300j-17) is 
amended to read as follows:

                ``endocrine disruptor screening program

    ``Sec. 1457.  (a) Testing of Substances.--
    ``(1) In General.--In carrying out the screening program under 
section 408(p) of the Federal Food, Drug, and Cosmetic Act, the 
Administrator shall provide for the testing of substances described in 
paragraph (2) in addition to the substances described in section 
408(p)(3) of such Act.
    ``(2) Covered Substances.--A substance is subject to testing 
pursuant to paragraph (1) if--
            ``(A) the substance may be found in sources of drinking 
        water; and
            ``(B) the Administrator determines that a substantial 
        population may be exposed to such substance.
    ``(3) Substances Already Subject to Testing.--Notwithstanding 
paragraph (2), a substance is not subject to testing pursuant to 
paragraph (1) if--
            ``(A) the substance is already subject to evaluation 
        determined by the Administrator to be equivalent to testing 
        pursuant to paragraph (1); or
            ``(B) the Administrator has already determined the effect 
        of the substance on the endocrine system.
    ``(4) Substances Derived From Degradation or Metabolism of Another 
Substance.--If a substance subject to testing pursuant to paragraph (1) 
(in this paragraph referred to as the `covered substance') is derived 
from the degradation or metabolism of another substance, or is used in 
or generated by the manufacture of another substance, the Administrator 
shall provide for such testing of the covered substance by the importer 
or manufacturer of the other substance.
    ``(b) Identification and Testing of Endocrine Disrupting Substances 
That May Be in Drinking Water.--
            ``(1) Identification.--Not later than 1 year after the date 
        of the enactment of the Endocrine Disruptor Screening 
        Enhancement Act of 2011, after opportunity for comment, the 
        Administrator shall publish--
                    ``(A) a plan for the identification of substances 
                for testing pursuant to subsection (a)(1); and
                    ``(B) a schedule for issuing test orders for all 
                substances by not later than 10 years after the date of 
                the enactment of the Endocrine Disruptor Screening 
                Enhancement Act of 2011, with the goal of testing, at a 
                minimum and consistent with subsection (a), all 
                substances that have been placed on the Drinking Water 
                Preliminary Contaminant Candidate List published 
                pursuant to section 1412(b)(1)(B)(i) and all substances 
                for which a national primary drinking water regulation 
                has been promulgated pursuant to section 1412(b)(1)(A).
        In publishing the plan and schedule required by this paragraph, 
        the Administrator shall obtain advice and direction from the 
        Science Advisory Board.
            ``(2) Prioritization; considerations.--In selecting 
        substances for identification pursuant to the plan under 
        paragraph (1)(A), the Administrator--
                    ``(A) shall prioritize the selection of substances 
                that pose the greatest public health concern, taking 
                into consideration (among other factors of public 
                health concern) the effect of such substances on 
                subgroups that comprise a meaningful portion of the 
                general population (such as infants, children, pregnant 
                women, the elderly, individuals with a history of 
                serious illness, and other subpopulations) that are 
                identifiable as being at greater risk of adverse health 
                effects due to exposure to substances in drinking 
                water; and
                    ``(B) shall take into consideration--
                            ``(i) available information on the extent 
                        of potential public exposures to the substances 
                        through drinking water;
                            ``(ii) the Drinking Water Preliminary 
                        Contaminant Candidate List published pursuant 
                        to section 1412(b)(1)(B)(i); and
                            ``(iii) substances for which a national 
                        primary drinking water regulation has been 
                        proposed or promulgated pursuant to 
                        1412(b)(1)(A).
    ``(c) Testing Protocol Process.--
            ``(1) In general.--Not later than 2 years after the date of 
        the enactment of the Endocrine Disruptor Screening Enhancement 
        Act of 2011, the Administrator shall, after opportunity for 
        comment, and after obtaining advice and direction from the 
        Science Advisory Board, publish guidance on developing or 
        updating protocols for testing of possible endocrine 
        disruptors. The guidance shall specify--
                    ``(A) the manner in which the Administrator will 
                evaluate and, where necessary, revise such protocols;
                    ``(B) the manner in which the Administrator will 
                determine when testing of substances will be required; 
                and
                    ``(C) the procedures by which other scientifically 
                relevant information can be used in lieu of some or all 
                of the information that otherwise would be collected 
                pursuant to testing under section 408(p) of the Federal 
                Food, Drug, and Cosmetic Act.
            ``(2) Minimum contents.--The procedures specified pursuant 
        to paragraph (1)(C) shall ensure that the Administrator may use 
        information that is prepared or provided by any person 
        (including a registrant, manufacturer, or importer of a 
        substance for which testing is required, and any other entity) 
        and shall apply equally with respect to any such person.
            ``(3) Amendments.--The Administrator may, after opportunity 
        for comment, and after obtaining advice and direction from the 
        Science Advisory Board, amend any guidance published pursuant 
        to this subsection.
    ``(d) Revision of Testing Protocols.--Not later than 2 years after 
the date of the enactment of the Endocrine Disruptor Screening 
Enhancement Act of 2011, the Administrator shall, after opportunity for 
comment, determine whether sufficient scientific information has been 
developed to warrant updating the screening protocols developed under 
section 408(p) of the Federal Food, Drug, and Cosmetic Act. Not later 
than 5 years after the date of the enactment of the Endocrine Disruptor 
Screening Enhancement Act of 2011, and every 3 years thereafter, the 
Administrator shall determine, consistent with the guidance published 
under subsection (c), whether to revise screening protocols under such 
section based on significant improvements in the sensitivity, accuracy, 
reliability, reproducibility, or efficiency of such protocols. In 
carrying out the preceding sentence the Administrator shall require, 
where practicable, the use of screening protocols that eliminate or 
reduce the number of animals used. Whenever the Administrator revises 
such a protocol, the Administrator shall also determine, after 
obtaining advice and direction from the Science Advisory Board or the 
advisory panel referred to in section 25(d) of the Federal Insecticide, 
Fungicide, and Rodenticide Act, as appropriate, whether any substance 
that has already been subjected to testing should be tested using the 
revised protocol.
    ``(e) Acceleration of Testing for Certain Substances.--
            ``(1) In general.--If the Administrator determines that--
                    ``(A) a substance is known to be found in sources 
                of drinking water;
                    ``(B) a substantial population is known to be 
                exposed to the substance; and
                    ``(C) the substance is either suspected to be an 
                endocrine disruptor or has a structural similarity to a 
                substance known to be an endocrine disruptor;
        the Administrator shall determine whether to require the 
        completion of testing for such substance on an accelerated 
        schedule, to enable the Administrator to determine the effect 
        of such substance on the endocrine system and ensure the 
        protection of public health.
            ``(2) Scientifically relevant information.--The 
        Administrator shall make any determination under paragraph (1) 
        using scientifically relevant information. In carrying out the 
        preceding sentence, the Administrator may rely on any available 
        scientifically relevant information, prepared or provided by 
        any person.
            ``(3) Guidance.--Not later than 1 year after the date of 
        the enactment of the Endocrine Disruptor Screening Enhancement 
        Act of 2011, the Administrator shall, after opportunity for 
        comment, publish guidance on how the Administrator will make 
        determinations under paragraph (1).
    ``(f) Results of Testing.--
            ``(1) Publication of data evaluation records.--Not later 
        than 6 months after receipt of testing results for a substance, 
        the Administrator shall prepare and, consistent with subsection 
        (g), publish data evaluation records for such results in a 
        publicly searchable database.
            ``(2) Administrative action.--Not later than 6 months after 
        receipt of testing results for a substance, the Administrator 
        shall--
                    ``(A) determine whether to take action related to 
                the substance under section 1412(b) or 1445, or other 
                appropriate statutory authority; and
                    ``(B) consistent with subsection (g), publish such 
                determination in a publicly searchable database.
            ``(3) Structured evaluation framework.--To assess the 
        overall weight of the evidence and relevance to humans and 
        wildlife of results of testing, the Administrator shall develop 
        and use a structured evaluative framework consisting of 
        science-based criteria, consistent with the protection of 
        public health and the environment, for systematically 
        evaluating endocrine mode of action and for determining data 
        relevance, quality, and reliability.
    ``(g) Public Database.--Beginning not later than 180 days after the 
date of the enactment of the Endocrine Disruptor Screening Enhancement 
Act of 2011 and consistent with section 552 of title 5, United States 
Code, the Administrator shall publish, in electronic format, a publicly 
searchable database that contains information regarding the testing 
program. Not later than 30 days after the date on which the information 
becomes available, the Administrator shall ensure that, at a minimum, 
the database--
            ``(1) identifies the substances selected for testing under 
        the program; and
            ``(2) includes the documents and information pertaining to 
        the status of testing activities for each such substance, 
        including test orders, deadlines for submission, the 
        Environmental Protection Agency's data evaluation records, the 
        Administrator's determination on whether regulatory action will 
        be taken under subsection (f), and the summary of chemical test 
        results.
    ``(h) Petition for Inclusion of a Substance in the Program.--
            ``(1) In general.--Any person may submit a petition to the 
        Administrator to--
                    ``(A) identify a substance pursuant to the plan 
                under subsection (b)(1)(A); or
                    ``(B) issue a test order requiring that a substance 
                be tested on an accelerated basis in accordance with 
                subsection (e).
            ``(2) Specification of facts.--Any petition under paragraph 
        (1) shall specify the facts that are claimed to establish that 
        an action described in subparagraph (A) or (B) of paragraph (1) 
        is warranted.
            ``(3) Administrative action.--Not later than 90 days after 
        the filing of a petition described under paragraph (1), the 
        Administrator shall determine whether the petition has 
        established that an action described in subparagraph (A) or (B) 
        of paragraph (1) is warranted and shall grant or deny the 
        petition. If the Administrator grants such petition, the 
        Administrator shall promptly identify the substance pursuant to 
        the plan under subsection (b)(1)(A), or issue an order 
        requiring testing on an accelerated basis in accordance with 
        subsection (e), as applicable. If the Administrator denies the 
        petition, the Administrator shall publish the reasons for such 
        denial in the Federal Register.
    ``(i) Coordination With Other Federal Agencies.--After the 
Administrator--
            ``(1) requires testing of a substance; or
            ``(2) based in whole or in part on the results of testing, 
        takes action related to a substance under section 1412(b) or 
        1445, or other appropriate statutory authority;
the Administrator shall give notice of such testing or action to 
Federal agencies which are authorized by other provisions of law to 
regulate the substance or products, materials, medications, processes, 
or practices that use the substance.
    ``(j) Reporting Requirement.--Not later than 1 year after the date 
of the enactment of the Endocrine Disruptor Screening Enhancement Act 
of 2011, and every 3 years thereafter, the Administrator shall provide 
a report to the Committee on Energy and Commerce of the House of 
Representatives and the Committee on Environment and Public Works of 
the Senate that describes--
            ``(1) progress made in identifying, testing, and regulating 
        endocrine disruptors as well as plans for future activities;
            ``(2) any change in screening or testing methodology and 
        evaluation or criteria for evaluating scientifically relevant 
        information;
            ``(3) actions taken to ensure communication and sharing of 
        scientific information with other Federal agencies and the 
        public; and
            ``(4) any deviations from the plan or schedule published 
        under subsections (b)(1)(A) and (b)(1)(B) as well as the 
        reasons therefor.
    ``(k) Testing Consortia, Compensation, and Compliance.--
            ``(1) In general.--Any person required by the Administrator 
        to conduct testing of an endocrine disruptor may--
                    ``(A) submit, on its own, data in response to an 
                order for such testing; and
                    ``(B) form (on a voluntary basis) a consortium in 
                order to satisfy the requirements of one or more orders 
                for such testing.
            ``(2) Reliance on consortium submissions.--Each member of a 
        consortium described in paragraph (1)(B) shall have full rights 
        to rely on all submissions of the consortium to satisfy the 
        requirements of any order for testing, but continues to be 
        individually subject to such requirements.
            ``(3) Sharing of costs.--
                    ``(A) In general.--Each member of a consortium 
                described in paragraph (1)(B) shall share the 
                applicable costs according to appropriate arrangements 
                established by the consortium members.
                    ``(B) Binding offer.--Whenever, to satisfy the 
                requirements of one or more orders for testing, any 
                person offers to form or join a consortium described in 
                paragraph (1)(B), or offers compensation to a person 
                that has already submitted data to the Administrator 
                satisfying an order for testing, such offer shall 
                constitute a binding offer to share an appropriate 
                portion of the applicable costs.
                    ``(C) Applicable costs.--In this subsection, the 
                term `applicable costs' includes the costs--
                            ``(i) incurred to generate and report 
                        information to comply with an order for 
                        testing; or
                            ``(ii) associated with the organization and 
                        administration of the consortium.
            ``(4) Dispute resolution.--
                    ``(A) In general.--In the event of any dispute 
                about an appropriate share or a fair method of 
                determining an appropriate share of applicable costs of 
                the testing requirements in a test order, any person 
                involved in the dispute may initiate binding 
                arbitration proceedings by requesting the Federal 
                Mediation and Conciliation Service to appoint an 
                arbitrator from the roster of arbitrators maintained by 
                such Service or a hearing with a regional office of the 
                American Arbitration Association. A copy of the request 
                shall be sent to each person from whom the requesting 
                party seeks compensation or who seeks compensation from 
                that party.
                    ``(B) No review of findings and determination.--The 
                findings and determination of the arbitrator in a 
                dispute initiated pursuant to subparagraph (A) shall be 
                final and conclusive, and no official or court of the 
                United States shall have power or jurisdiction to 
                review any such findings and determination, except in 
                the case of fraud, misrepresentation, or other 
                misconduct by one of the parties to the arbitration or 
                by the arbitrator.
                    ``(C) Payment of fee and expenses.--The parties to 
                arbitration initiated pursuant to subparagraph (A) 
                shall share equally in the payment of the fee and 
                expenses of the arbitrator.
            ``(5) Enforcement.--If the Administrator determines that 
        any person seeking to comply with an order for testing by 
        relying on a submission made by a consortium or an original 
        data submitter has failed to make an offer in accordance with 
        paragraph (3)(B), to participate in an arbitration proceeding 
        under paragraph (4), or to comply with the terms of an 
        agreement or arbitration decision concerning sharing of 
        applicable costs under paragraph (3), that person is deemed to 
        have failed to comply with an order under subparagraph (A) of 
        section 408(p)(5) of the Federal Food, Drug, and Cosmetic Act 
        for purposes of subparagraphs (B) and (C) of such section.
    ``(l) Definitions.--In this section:
            ``(1) The term `endocrine disruptor' means an exogenous 
        agent or mixture of agents that interferes with or alters the 
        synthesis, secretion, transport, metabolism, binding action, or 
        elimination of hormones that are present in the body and are 
        responsible for homeostasis, growth, neurological signaling, 
        reproduction and developmental process, or any other effect 
        that the Administrator has designated as an `endocrine effect' 
        pursuant to section 408(p)(1) of the Federal Food, Drug, and 
        Cosmetic Act.
            ``(2) The term `testing' means the testing of a substance 
        pursuant to the screening program under section 408(p) of the 
        Federal Food, Drug, and Cosmetic Act, including a test of a 
        substance that is intended to identify substances that have the 
        potential to interact with the endocrine system or that is 
        intended to determine the endocrine-related effects caused by 
        such substance and obtain information about effects at various 
        doses.
    ``(m) Authorization of Appropriations.--To carry out this section, 
there is authorized to be appropriated $5,000,000 for each of fiscal 
years 2012 through 2016.''.
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