Sec. 5. Testing of chemical substances or mixtures
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Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended— by striking subsections (a), (b), (c), (d), and (g); by redesignating subsections
(e)and
(f)as subsections
(f)and (g), respectively; in subsection
(f)(as so redesignated)— by striking rule each place it appears and inserting rule, testing consent agreement, or order ; by striking under subsection
(a)each place it appears and inserting under this subsection ; and in paragraph (1)(B), in the last sentence, by striking rulemaking ; in subsection
(g)(as so redesignated)— in the first sentence, by striking from cancer, gene mutations, or birth defects ; and by striking the last sentence; and by inserting before subsection
(f)(as so redesignated) the following: The Administrator may require the development of new information relating to a chemical substance or mixture in accordance with this section if the Administrator determines that the information is necessary— to review a notice under section 5(d) or to perform a safety assessment or safety determination under section 6; to implement a requirement imposed in a consent agreement or order issued under section 5(d)(4) or under a rule promulgated under section 6(d)(3); pursuant to section 12(a)(4); or at the request of the implementing authority under another Federal law, to meet the regulatory testing needs of that authority. Except as provided in subparagraph (B), the Administrator may require the development of new information for the purposes of section 4A. Testing required under subparagraph
(A)shall not be required for the purpose of establishing or implementing a minimum information requirement. The Administrator may require the development of new information pursuant to subparagraph
(A)only if the Administrator determines that additional information is necessary to establish the priority of a chemical substance. Subject to section 3A(h), the Administrator may require the development of information described in paragraph
(1)or
(2)by— promulgating a rule; entering into a testing consent agreement; or issuing an order. A rule, testing consent agreement, or order issued under this subsection shall include— identification of the chemical substance or mixture for which testing is required; identification of the persons required to conduct the testing; test protocols and methodologies for the development of test data and information for the chemical substance or mixture, including specific reference to reliable nonanimal test procedures; and specification of the period within which individuals and entities required to conduct the testing shall submit to the Administrator the information developed in accordance with the procedures described in clause (iii). In determining the procedures and period to be required under subparagraph (A), the Administrator shall take into consideration— the relative costs of the various test protocols and methodologies that may be required; and the reasonably foreseeable availability of facilities and personnel required to perform the testing. In promulgating a rule, entering into a testing consent agreement, or issuing an order for the development of additional information (including information on exposure or exposure potential) pursuant to this section, the Administrator shall— identify the need intended to be met by the rule, agreement, or order; explain why information reasonably available to the Administrator at that time is inadequate to meet that need, including a reference, as appropriate, to the information identified in paragraph (2)(B); and explain the basis for any decision that requires the use of vertebrate animals. If the Administrator issues an order under this section, the Administrator shall issue a statement providing a justification for why issuance of an order is warranted instead of promulgating a rule or entering into a testing consent agreement. A statement described in subparagraph
(A)shall contain a description of— information that is readily accessible to the Administrator, including information submitted under any other provision of law; the extent to which the Administrator has obtained or attempted to obtain the information through voluntary submissions; and any information relied on in safety assessments for other chemical substances relevant to the chemical substances that would be the subject of the order. The Administrator shall minimize, to the extent practicable, the use of vertebrate animals in testing of chemical substances or mixtures, by— encouraging and facilitating— the use of integrated and tiered testing and assessment strategies; the use of best available science in existence on the date on which the test is conducted; the use of test methods that eliminate or reduce the use of animals while providing information of high scientific quality; the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide reliable and useful information on other chemical substances in the category; the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests; and the submission of information from— animal-based studies; and emerging methods and models; and funding research and validation studies to reduce, refine, and replace the use of animal tests in accordance with this subsection. To promote the development and timely incorporation of new testing methods that are not based on vertebrate animals, the Administrator shall— after providing an opportunity for public comment, develop a strategic plan to promote the development and implementation of alternative test methods and testing strategies to generate information under this title that can reduce, refine, or replace the use of vertebrate animals, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening; as practicable, ensure that the strategic plan developed under subparagraph
(A)is reflected in the development of requirements for testing under this section; beginning on the date that is 5 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act and every 5 years thereafter, submit to Congress a report that describes the progress made in implementing this subsection and goals for future alternative test methods implementation; and fund and carry out research, development, performance assessment, and translational studies to accelerate the development of test methods and testing strategies that reduce, refine, or replace the use of vertebrate animals in any testing under this title. On request from a manufacturer or processor that is required to conduct testing of a chemical substance or mixture on vertebrate animals under this section, the Administrator may adapt or waive the requirement, if the Administrator determines that— there is sufficient evidence from several independent sources of information to support a conclusion that a chemical substance or mixture has, or does not have, a particular property if the information from each individual source alone is insufficient to support the conclusion; as a result of 1 or more physical or chemical properties of the chemical substance or mixture or other toxicokinetic considerations— the substance cannot be absorbed; or testing for a specific endpoint is technically not practicable to conduct; or a chemical substance or mixture cannot be tested in vertebrate animals at concentrations that do not result in significant pain or distress, because of physical or chemical properties of the chemical substance or mixture, such as a potential to cause severe corrosion or severe irritation to the tissues of the animal. The Administrator may require the development of information by— manufacturers and processors of the chemical substance or mixture; and persons that begin to manufacture or process the chemical substance or mixture— after the effective date of the rule, testing consent agreement, or order; but subject to paragraph (3), before the period ending on the date that is 180 days after the end of the period described in this section. The Administrator may permit 2 or more persons identified in subparagraph
(A)or
(B)of paragraph
(1)to designate 1 of the persons or a qualified third party— to develop the information; and to submit the information on behalf of the persons making the designation. A person otherwise subject to a rule, testing consent agreement, or order under this section may submit to the Administrator an application for an exemption on the basis that the information is being developed by a person designated under paragraph (2). If the Administrator accepts an application submitted under subparagraph (A), the Administrator shall direct the applicant to provide to the person designated under paragraph
(2)fair and equitable reimbursement, as agreed to between the applicant and the designee. If the applicant and a person designated under paragraph
(2)cannot reach agreement on the amount of fair and equitable reimbursement, the amount shall be determined by arbitration. If, after granting an exemption under this paragraph, the Administrator determines that a person covered by the exemption has failed to comply with the rule, testing consent agreement, or order, the Administrator shall— by order, terminate the exemption; and notify in writing each person that received an exemption of the requirements with respect to which the exemption was granted. Subject to section 14, the Administrator shall make available to the public all testing consent agreements and orders and all information submitted under this section. . Section 104(i)(5)(A) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 ( 42 U.S.C. 9604(i)(5)(A) ) is amended in the third sentence by striking section 4(e) and inserting section 4(f) .
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