Sec. 8. Safety assessments and safety determinations
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Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended— by striking the section designation and heading and inserting the following: ; by redesignating subsections
(e)and
(f)as subsections
(g)and (h), respectively; by striking subsections
(a)through
(d)and inserting the following: The Administrator— shall conduct a safety assessment and make a safety determination of each high-priority substance in accordance with subsections
(b)and (c); shall, as soon as practicable and not later than 6 months after the date on which a chemical substance is designated as a high-priority substance, define the scope of the safety assessment and safety determination to be conducted pursuant to this section, including the hazards, exposures, conditions of use, and potentially exposed or susceptible populations that the Administrator expects to consider; as appropriate based on the results of a safety determination, shall establish restrictions pursuant to subsection (d); shall complete a safety assessment and safety determination not later than 3 years after the date on which a chemical substance is designated as a high-priority substance; shall promulgate a final rule pursuant to subsection
(d)by not later than 2 years after the date on which the safety determination is completed; and may extend any deadline under this subsection for a reasonable period of time after an adequate public justification, subject to the condition that the aggregate length of all extensions of deadlines under paragraphs
(4)and
(5)and any deferral under subsection (c)(2) does not exceed 2 years. Nothing in this Act prevents the Administrator from initiating a safety assessment or safety determination regarding a chemical substance, or from continuing or completing such a safety assessment or safety determination that was initiated before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , prior to the effective date of the policies and procedures required to be established by the Administrator under section 3A or 4A. As policies and procedures under section 3A and 4A are established, to the maximum extent practicable, the Administrator shall integrate the policies and procedures into ongoing safety assessments and safety determinations. Nothing in this Act requires the Administrator to revise or withdraw a completed safety assessment, safety determination, or rule solely because the action was completed prior to the completion of a policy or procedure established under section 3A or 4A, and the validity of a completed assessment, determination, or rule shall not be determined based on the content of such a policy or procedure. Based on a review of the information available to the Administrator, including draft safety assessments submitted by interested persons, and subject to section 18, the Administrator shall determine that— the relevant chemical substance meets the safety standard; the relevant chemical substance does not meet the safety standard, in which case the Administrator shall, by rule under subsection (d)— impose restrictions necessary to ensure that the chemical substance meets the safety standard under the conditions of use; or if the safety standard cannot be met with the application of restrictions, ban or phase out the chemical substance, as appropriate; or additional information is necessary in order to make a determination under subparagraph
(A)or (B), in which case the Administrator shall take appropriate action under paragraph (2). If the Administrator determines that additional information is necessary to make a safety assessment or safety determination for a high-priority substance, the Administrator— shall provide an opportunity for interested persons to submit the additional information; may promulgate a rule, enter into a testing consent agreement, or issue an order under section 4 to require the development of the information; may defer, for a reasonable period consistent with the deadlines described in subsection (a), a safety assessment and safety determination until after receipt of the information; and consistent with the deadlines described in subsection (a), on receipt of information the Administrator finds supports the safety assessment and safety determination, shall make a determination under paragraph (1). In requesting the development or submission of information under this section, the Administrator shall establish a deadline for the submission of the information. If the Administrator makes a determination under subsection (c)(1)(B) with respect to a chemical substance, the Administrator shall promulgate a rule establishing restrictions necessary to ensure that the chemical substance meets the safety standard. The rule promulgated pursuant to this subsection— may— apply to mixtures containing the chemical substance, as appropriate; and exempt replacement parts for articles manufactured prior to the applicable compliance deadline; and shall include dates by which compliance is mandatory, which— shall be as soon as practicable; and as determined by the Administrator, may vary for different affected persons. The Administrator shall consult with the Assistant Secretary of Labor for Occupational Safety and Health before adopting any prohibition or other restriction under this subsection to address workplace exposures. For the purposes of this Act, the term requirement as used in this section does not displace common law. A restriction under paragraph
(1)may include, as appropriate— subject to section 18, a requirement that a chemical substance shall be marked with, or accompanied by, clear and adequate minimum warnings and instructions with respect to use, distribution in commerce, or disposal, or any combination of those activities, with the form and content of the minimum warnings and instructions to be prescribed by the Administrator; a requirement that manufacturers or processors of the chemical substance shall— make and retain records of the processes used to manufacture or process the chemical substance; describe and apply the relevant quality control procedures followed in the manufacturing or processing of the substance; or monitor or conduct tests that are reasonably necessary to ensure compliance with the requirements of any rule under this subsection; a restriction on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce; a requirement to ban or phase out, or any other rule regarding, the manufacture, processing, or distribution in commerce of the chemical substance for— a particular use; a particular use at a concentration in excess of a level specified by the Administrator; or all uses; a restriction on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce for— a particular use; or a particular use at a concentration in excess of a level specified by the Administrator; a requirement to ban, phase out, or otherwise restrict any method of commercial use of the chemical substance; a requirement to ban, phase out, or otherwise restrict any method of disposal of the chemical substance or any article containing the chemical substance; and a requirement directing manufacturers or processors of the chemical substance to give notice of the Administrator’s determination under subsection (c)(1)(B) to distributors in commerce of the chemical substance and, to the extent reasonably ascertainable, to other persons in the chain of commerce in possession of the chemical substance. In deciding which restrictions to impose under paragraph
(3)as part of developing a rule under paragraph (1), the Administrator shall take into consideration, to the extent practicable based on reasonably available information, the quantifiable and nonquantifiable costs and benefits of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator. As part of the analysis, the Administrator shall review any 1 or more technically and economically feasible alternatives to the chemical substance that the Administrator determines are relevant to the rulemaking. In proposing a rule under paragraph (1), the Administrator shall make publicly available any analysis conducted under this paragraph. In making final a rule under paragraph (1), the Administrator shall include a statement describing how the analysis considered under subparagraph
(A)was taken into account. The Administrator may exempt 1 or more uses of a chemical substance from any restriction in a rule promulgated under paragraph
(1)if the Administrator determines that— the rule cannot be complied with, without— harming national security; causing significant disruption in the national economy due to the lack of availability of a chemical substance; or interfering with a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure; or the use of the chemical substance, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. In proposing a rule under paragraph
(1)that includes an exemption under this paragraph, the Administrator shall make publicly available any analysis conducted under this paragraph to assess the need for the exemption. In making final a rule under paragraph
(1)that includes an exemption under this paragraph, the Administrator shall include a statement describing how the analysis considered under subparagraph
(B)was taken into account. In determining whether an exemption should be granted under this paragraph for a chemical substance for which a ban or phase-out is proposed, the Administrator shall take into consideration, to the extent practicable based on reasonably available information, the quantifiable and nonquantifiable costs and benefits of the 1 or more technically and economically feasible alternatives to the chemical substance most likely to be used in place of the chemical substance under the conditions of use if the rule is promulgated. As part of a rule promulgated under paragraph (1), the Administrator shall include conditions in any exemption established under this paragraph, including reasonable recordkeeping, monitoring, and reporting requirements, to the extent that the Administrator determines the conditions are necessary to protect health and the environment while achieving the purposes of the exemption. The Administrator shall establish, as part of a rule under paragraph
(1)that contains an exemption under this paragraph, a time limit on any exemption for a time to be determined by the Administrator as reasonable on a case-by-case basis. The Administrator, by rule, may extend, modify, or eliminate the exemption if the Administrator determines, on the basis of reasonably available information and after adequate public justification, the exemption warrants extension or is no longer necessary. Subject to subclause (II), the Administrator shall issue exemptions and establish time periods by considering factors determined by the Administrator to be relevant to the goals of fostering innovation and the development of alternatives that meet the safety standard. Any renewal of an exemption in the case of a rule requiring the ban or phase-out of a chemical substance shall not exceed 5 years. The Administrator may declare a proposed rule under subsection
(d)to be effective on publication of the rule in the Federal Register and until the effective date of final action taken respecting the rule, if— the Administrator determines that— the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance or mixture subject to the proposed rule or any combination of those activities is likely to result in an unreasonable risk of serious or widespread harm to health or the environment before the effective date; and making the proposed rule so effective is necessary to protect the public interest; and in the case of a proposed rule to prohibit the manufacture, processing, or distribution of a chemical substance or mixture because of the risk determined under paragraph (1)(A), a court has granted relief in an action under section 7 with respect to that risk associated with the chemical substance or mixture. Under this section and subject to section 18— a safety determination, and the associated safety assessment, for a chemical substance that the Administrator determines under subsection
(c)meets the safety standard, shall be considered to be a final agency action, effective beginning on the date of issuance of the final safety determination; and a final rule promulgated under subsection (d), and the associated safety assessment and safety determination that a chemical substance does not meet the safety standard, shall be considered to be a final agency action, effective beginning on the date of promulgation of the final rule. ; and in subsection
(g)(as redesignated by paragraph (2))— by striking paragraph (4); and by redesignating paragraph
(5)as paragraph (4).
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Sec. 8
Safety assessments and safety determinations
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