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), (e), and (g); in subsection (f)— in the first sentence— by striking from cancer, gene mutations, or birth defects ; and by inserting , without taking into account cost or other nonrisk factors before the period at the end; and by striking the last sentence; and by inserting before subsection
(f)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. 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 information for the chemical substance or mixture, including specific reference to any 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; the reasonably foreseeable availability of facilities and personnel required to perform the testing; and the deadlines applicable to the Administrator under section 6(a). The Administrator shall consider the recommendations of other Federal agencies regarding the chemical substances and mixtures to which the Administrator shall give priority consideration under this section. 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— prior to making a request or adopting a requirement for testing using vertebrate animals, taking into consideration, as appropriate and to the extent practicable, reasonably available— toxicity information; computational toxicology and bioinformatics; high-throughput screening methods and the prediction models of those methods; and scientifically reliable and relevant alternatives to tests on animals that would provide equivalent information; 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— not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , 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; identify in the strategic plan developed under subparagraph
(A)particular alternative test methods or testing strategies that do not require new vertebrate animal testing and are scientifically reliable, relevant, and capable of providing information of equivalent scientific reliability and quality to that which would be obtained from vertebrate animal testing; provide an opportunity for public notice and comment on the contents of the plan developed under subparagraph (A), including the criteria for considering scientific reliability, relevance, and equivalent information and the test methods and strategies identified in subparagraph (C); 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; 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; and identify synergies with the related information requirements of other jurisdictions to minimize the potential for additional or duplicative testing. 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. Any person developing information for submission under this title on a voluntary basis and not pursuant to any request or requirement by the Administrator shall first attempt to develop the information by means of an alternative or nonanimal test method or testing strategy that the Administrator has determined under paragraph (2)(C) to be scientifically reliable, relevant, and capable of providing equivalent information, before conducting new animal testing. Nothing in this paragraph— requires the Administrator to review the basis on which the person is conducting testing described in subparagraph (A); prohibits the use of other test methods or testing strategies by any person for purposes other than developing information for submission under this title on a voluntary basis; or prohibits the use of other test methods or testing strategies by any person, subsequent to the attempt to develop information using the test methods and testing strategies identified by the Administrator under paragraph (2)(C). 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. 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 submission of information by the applicant on the chemical substance or mixture would be duplicative of— information on the chemical substance or mixture that— has been submitted to the Administrator pursuant to a rule, consent agreement, or order under this section; or is being developed by a person designated under paragraph (2); or information on an equivalent chemical substance or mixture that— has been submitted to the Administrator pursuant to a rule, consent agreement, or order under this section; or is being developed by a person designated under paragraph (2). If the Administrator accepts an application submitted under subparagraph (A), before the end of the reimbursement period described in clause (iii), 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. For the purposes of this subparagraph, the reimbursement period for any information for a chemical substance or mixture is a period— beginning on the date the information is submitted in accordance with a rule, testing consent agreement, or order under this section; and ending on the later of— 5 years after the date referred to in subclause (I); or the last day of the period that begins on the date referred to in subclause
(I)and that is equal to the period that the Administrator determines was necessary to develop the information. If, after granting an exemption under this paragraph, the Administrator determines that no person designated under paragraph
(2)has complied 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. Except as provided in subparagraph (D), the Administrator shall employ a tiered screening and testing process, under which the results of screening-level tests or assessments of available information inform the decision as to whether 1 or more additional tests are necessary. The screening-level tests required for a chemical substance or mixture may include tests for hazard (which may include in silico, in vitro, and in vivo tests), environmental and biological fate and transport, and measurements or modeling of exposure or exposure potential, as appropriate. Screening-level tests shall be used— to screen chemical substances or mixtures for potential adverse effects; and to inform a decision of the Administrator regarding whether more complex or targeted additional testing is necessary. If the Administrator determines under subparagraph
(B)that additional testing is necessary to provide more definitive information for safety assessments or safety determinations, the Administrator may require more advanced tests for potential health or environmental effects or exposure potential. The Administrator may require more advanced testing without conducting screening-level testing when other information available to the Administrator justifies the advanced testing, pursuant to guidance developed by the Administrator under this section. 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 inserting (as in effect on the day before the date of enactment of the after Frank R. Lautenberg Chemical Safety for the 21st Century Act ) Toxic Substances Control Act .
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