Sec. 6. Prioritization, risk evaluation, and regulation of chemical substances and mixtures
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Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended— by striking the section heading and inserting ; Prioritization, risk evaluation, and regulation of chemical substances and mixtures in subsection (a)— by striking finds that there is a reasonable basis to conclude and inserting determines in accordance with subsection (b)(4)(A) ; by striking or will present ; by inserting and subject to section 18, and in accordance with subsection (c)(2), after shall by rule ; by striking to protect adequately against such risk using the least burdensome requirements and inserting so that the chemical substance or mixture no longer presents such risk ; by inserting or otherwise restricting after prohibiting in paragraphs (1)(A) and (2)(A); by inserting minimum before warnings both places it appears in paragraph (3); by striking and monitor or conduct tests and inserting or monitor or conduct tests in paragraph (4); and in paragraph (7)— by striking such unreasonable risk of injury and inserting such determination ; and by striking such risk of injury and inserting such determination ; by amending subsection
(b)to read as follows: Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall establish, by rule, a risk-based screening process, including criteria for designating chemical substances as high-priority substances for risk evaluations or low-priority substances for which risk evaluations are not warranted at the time. The process to designate the priority of chemical substances shall include a consideration of the hazard and exposure potential of a chemical substance or a category of chemical substances (including consideration of persistence and bioaccumulation, potentially exposed or susceptible subpopulations and storage near significant sources of drinking water), the conditions of use or significant changes in the conditions of use of the chemical substance, and the volume or significant changes in the volume of the chemical substance manufactured or processed. The Administrator shall designate as a high-priority substance a chemical substance that the Administrator concludes, without consideration of costs or other nonrisk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator. The Administrator shall designate a chemical substance as a low-priority substance if the Administrator concludes, based on information sufficient to establish, without consideration of costs or other nonrisk factors, that such substance does not meet the standard identified in clause
(i)for designating a chemical substance a high-priority substance. The rulemaking required in subparagraph
(A)shall ensure that the time required to make a priority designation of a chemical substance be no shorter than nine months and no longer than 1 year, and that the process for such designations includes— a requirement that the Administrator request interested persons to submit relevant information on a chemical substance that the Administrator has initiated the prioritization process on, before proposing a priority designation for the chemical substance, and provide 90 days for such information to be provided; a requirement that the Administrator publish each proposed designation of a chemical substance as a high- or low-priority substance, along with an identification of the information, analysis, and basis used to make the proposed designations, and provide 90 days for public comment on each such proposed designation; and a process by which the Administrator may extend the deadline in clause
(i)for up to three months in order to receive or evaluate information required to be submitted in accordance with section 4(a)(2)(B), subject to the limitation that if the information available to the Administrator at the end of such an extension remains insufficient to enable the designation of the chemical substance as a low-priority substance, the Administrator shall designate the chemical substance as a high-priority substance. Not later than 180 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall ensure that risk evaluations are being conducted on 10 chemical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments and shall publish the list of such chemical substances during the 180 day period. Not later than three and one half years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall ensure that risk evaluations are being conducted on at least 20 high-priority substances and that at least 20 chemical substances have been designated as low-priority substances, subject to the limitation that at least 50 percent of all chemical substances on which risk evaluations are being conducted by the Administrator are drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments. The Administrator shall continue to designate priority substances and conduct risk evaluations in accordance with this subsection at a pace consistent with the ability of the Administrator to complete risk evaluations in accordance with the deadlines under paragraph (4)(G). In designating high-priority substances, the Administrator shall give preference to— chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments as having a Persistence and Bioaccumulation Score of 3; and chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments that are known human carcinogens and have high acute and chronic toxicity. In identifying priorities for risk evaluation and conducting risk evaluations of metals and metal compounds, the Administrator shall use the Framework for Metals Risk Assessment of the Office of the Science Advisor, Risk Assessment Forum, and dated March 2007, or a successor document that addresses metals risk assessment and is peer reviewed by the Science Advisory Board. Upon designating a chemical substance as a high-priority substance, the Administrator shall initiate a risk evaluation on the substance. The Administrator may revise the designation of a low-priority substance based on information made available to the Administrator. The Administrator shall designate at least one high-priority substance upon the completion of each risk evaluation (other than risk evaluations for chemical substances designated under paragraph (4)(C)(ii)). The Administrator shall conduct risk evaluations pursuant to this paragraph to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the risk evaluation by the Administrator, under the conditions of use. Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall establish, by rule, a process to conduct risk evaluations in accordance with subparagraph (A). The Administrator shall conduct and publish risk evaluations, in accordance with the rule promulgated under subparagraph (B), for a chemical substance— that has been identified under paragraph (2)(A) or designated under paragraph (1)(B)(i); and subject to subparagraph (E), that a manufacturer of the chemical substance has requested, in a form and manner and using the criteria prescribed by the Administrator in the rule promulgated under subparagraph (B), be subjected to a risk evaluation. The Administrator shall, not later than 6 months after the initiation of a risk evaluation, publish the scope of the risk evaluation to be conducted, including the hazards, exposures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider, and, for each designation of a high-priority substance, ensure not less than 12 months between the initiation of the prioritization process for the chemical substance and the publication of the scope of the risk evaluation for the chemical substance, and for risk evaluations conducted on chemical substances that have been identified under paragraph (2)(A) or selected under subparagraph (E)(iv)(II) of this paragraph, ensure not less than 3 months before the Administrator publishes the scope of the risk evaluation. The Administrator shall ensure that, of the number of chemical substances that undergo a risk evaluation under clause
(i)of subparagraph (C), the number of chemical substances undergoing a risk evaluation under clause
(ii)of subparagraph
(C)is— not less than 25 percent, if sufficient requests are made under clause
(ii)of subparagraph (C); and not more than 50 percent. Requests for risk evaluations under subparagraph (C)(ii) shall be subject to the payment of fees pursuant to section 26(b), and the Administrator shall not expedite or otherwise provide special treatment to such risk evaluations. In deciding whether to grant requests under subparagraph (C)(ii), the Administrator shall give preference to requests for risk evaluations on chemical substances for which the Administrator determines that restrictions imposed by 1 or more States have the potential to have a significant impact on interstate commerce or health or the environment. Chemical substances for which requests have been granted under subparagraph (C)(ii) shall not be subject to section 18(b). Requests for risk evaluations on chemical substances which are made under subparagraph (C)(ii) and that are drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments shall be granted at the discretion of the Administrator and not be subject to clause (i)(II). In conducting a risk evaluation under this subsection, the Administrator shall— integrate and assess available information on hazards and exposures for the conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health or the environment and information on potentially exposed or susceptible subpopulations identified as relevant by the Administrator; describe whether aggregate or sentinel exposures to a chemical substance under the conditions of use were considered, and the basis for that consideration; not consider costs or other nonrisk factors; take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the conditions of use of the chemical substance; and describe the weight of the scientific evidence for the identified hazard and exposure. The Administrator— shall complete a risk evaluation for a chemical substance as soon as practicable, but not later than 3 years after the date on which the Administrator initiates the risk evaluation under subparagraph (C); and may extend the deadline for a risk evaluation for not more than 6 months. The Administrator shall provide no less than 30 days public notice and an opportunity for comment on a draft risk evaluation prior to publishing a final risk evaluation. ; by amending subsection
(c)to read as follows:
(a)rules If the Administrator determines that a chemical substance presents an unreasonable risk of injury to health or the environment in accordance with subsection (b)(4)(A), the Administrator— shall propose in the Federal Register a rule under subsection
(a)for the chemical substance not later than 1 year after the date on which the final risk evaluation regarding the chemical substance is published; shall publish in the Federal Register a final rule not later than 2 years after the date on which the final risk evaluation regarding the chemical substance is published; and may extend the deadlines under this paragraph for not more than 2 years, subject to the condition that the aggregate length of extensions under this subparagraph and subsection (b)(4)(G)(ii) does not exceed 2 years, and subject to the limitation that the Administrator may not extend a deadline for the publication of a proposed or final rule regarding a chemical substance drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments or a chemical substance that, with respect to persistence and bioaccumulation, scores high for 1 and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012 (or a successor scoring system), without adequate public justification that demonstrates, following a review of the information reasonably available to the Administrator, that the Administrator cannot complete the proposed or final rule without additional information regarding the chemical substance. In proposing and promulgating a rule under subsection
(a)with respect to a chemical substance or mixture, the Administrator shall consider and publish a statement based on reasonably available information with respect to— the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chemical substance or mixture; the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environment to such substance or mixture; the benefits of the chemical substance or mixture for various uses; and the reasonably ascertainable economic consequences of the rule, including consideration of— the likely effect of the rule on the national economy, small business, technological innovation, the environment, and public health; the costs and benefits of the proposed and final regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator; and the cost effectiveness of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by the Administrator. In selecting among prohibitions and other restrictions, the Administrator shall factor in, to the extent practicable, the considerations under subparagraph
(A)in accordance with subsection (a). Based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use of a chemical substance or mixture, and in setting an appropriate transition period for such action, the Administrator shall consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be prohibited or restricted, will be reasonably available as a substitute when the proposed prohibition or other restriction takes effect. The Administrator shall exempt replacement parts for complex durable goods and complex consumer goods that are designed prior to the date of publication in the Federal Register of the rule under subsection (a), unless the Administrator finds that such replacement parts contribute significantly to the risk, identified in a risk evaluation conducted under subsection (b)(4)(A), to the general population or to an identified potentially exposed or susceptible subpopulation. In this subparagraph— the term complex consumer goods means electronic or mechanical devices composed of multiple manufactured components, with an intended useful life of 3 or more years, where the product is typically not consumed, destroyed, or discarded after a single use, and the components of which would be impracticable to redesign or replace; and the term complex durable goods means manufactured goods composed of 100 or more manufactured components, with an intended useful life of 5 or more years, where the product is typically not consumed, destroyed, or discarded after a single use. In selecting among prohibitions and other restrictions, the Administrator shall apply such prohibitions or other restrictions to an article or category of articles containing the chemical substance or mixture only to the extent necessary to address the identified risks from exposure to the chemical substance or mixture from the article or category of articles so that the substance or mixture does not present an unreasonable risk of injury to health or the environment identified in the risk evaluation conducted in accordance with subsection (b)(4)(A). When prescribing a rule under subsection
(a)the Administrator shall proceed in accordance with section 553 of title 5, United States Code (without regard to any reference in such section to sections 556 and 557 of such title), and shall also— publish a notice of proposed rulemaking stating with particularity the reason for the proposed rule; allow interested persons to submit written data, views, and arguments, and make all such submissions publicly available; promulgate a final rule based on the matter in the rulemaking record; and make and publish with the rule the determination described in subsection (a). ; in subsection (d)— by redesignating paragraph
(2)as paragraph (3); by striking paragraph
(1)and inserting the following: In any rule under subsection (a), the Administrator shall— specify the date on which it shall take effect, which date shall be as soon as practicable; except as provided in subparagraphs
(C)and (D), specify mandatory compliance dates for all of the requirements under a rule under subsection (a), which shall be as soon as practicable, but not later than 5 years after the date of promulgation of the rule, except in a case of a use exempted under subsection (g); specify mandatory compliance dates for the start of ban or phase-out requirements under a rule under subsection (a), which shall be as soon as practicable, but not later than 5 years after the date of promulgation of the rule, except in the case of a use exempted under subsection (g); specify mandatory compliance dates for full implementation of ban or phase-out requirements under a rule under subsection (a), which shall be as soon as practicable; and provide for a reasonable transition period. As determined by the Administrator, the compliance dates established under paragraph
(1)may vary for different affected persons. ; and in paragraph (3), as so redesignated by subparagraph
(A)of this paragraph— in subparagraph (A)— by striking upon its publication and all that follows through respecting such rule if and inserting , and compliance with the proposed requirements to be mandatory, upon publication in the Federal Register of the proposed rule and until the compliance dates applicable to such requirements in a final rule promulgated under section 6(a) or until the Administrator revokes such proposed rule, in accordance with subparagraph (B), if ; and in clause (i)(I), by inserting without consideration of costs or other non-risk factors after effective date ; and in subparagraph (B), by striking , provide reasonable opportunity and all that follows through the period at the end and inserting in accordance with subsection (c), and either promulgate such rule (as proposed or with modifications) or revoke it. ; in subsection (e)(4), by striking paragraphs (2), (3), and
(4)and inserting paragraph
(3); and by adding at the end the following new subsections: The Administrator may, as part of a rule promulgated under subsection (a), or in a separate rule, grant an exemption from a requirement of a subsection
(a)rule for a specific condition of use of a chemical substance or mixture, if the Administrator finds that— the specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure; compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure; or the specific condition of use of the chemical substance or mixture, as compared to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety. In proposing an exemption under this subsection, the Administrator shall analyze the need for the exemption, and shall make public the analysis and a statement describing how the analysis was taken into account. The Administrator shall establish, as part of a rule under this subsection, a time limit on any exemption for a time to be determined by the Administrator as reasonable on a case-by-case basis, and, by rule, may extend, modify, or eliminate an exemption if the Administrator determines, on the basis of reasonably available information and after adequate public justification, the exemption warrants extension or modification or is no longer necessary. As part of a rule promulgated under this subsection, the Administrator shall include conditions, 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. Not later than 3 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator shall propose rules under subsection
(a)with respect to chemical substances identified in the 2014 update of the TSCA Work Plan for Chemical Assessments— that the Administrator has a reasonable basis to conclude are toxic and that with respect to persistence and bioaccumulation score high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012 (or a successor scoring system), and are not a metal or a metal compound, and for which the Administrator has not completed a Work Plan Problem Formulation, initiated a review under section 5, or entered into a consent agreement under section 4, prior to the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act; and exposure to which under the conditions of use is likely to the general population or to a potentially exposed or susceptible subpopulation identified by the Administrator, or the environment, on the basis of an exposure and use assessment conducted by the Administrator. The Administrator shall not be required to conduct risk evaluations on chemical substances that are subject to paragraph (1). Not later than 18 months after proposing a rule pursuant to paragraph (1), the Administrator shall promulgate a final rule under subsection (a). In selecting among prohibitions and other restrictions promulgated in a rule under subsection
(a)pursuant to paragraph (1), the Administrator shall address the risks of injury to health or the environment that the Administrator determines are presented by the chemical substance and shall reduce exposure to the substance to the extent practicable.
(b)If, at any time prior to the date that is 90 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act, the Administrator makes a designation under subsection (b)(1)(B)(i), or receives a request under subsection (b)(4)(C)(ii), such chemical substance shall not be subject to this subsection, except that in selecting among prohibitions and other restrictions promulgated in a rule pursuant to subsection (a), the Administrator shall both ensure that the chemical substance meets the rulemaking standard under subsection
(a)and reduce exposure to the substance to the extent practicable. Under this section and subject to section 18— a determination by the Administrator under subsection (b)(4)(A) that a chemical substance does not present an unreasonable risk of injury to health or the environment shall be issued by order and considered to be a final agency action, effective beginning on the date of issuance of the order; and a final rule promulgated under subsection (a), including the associated determination by the Administrator under subsection (b)(4)(A) that a chemical substance presents an unreasonable risk of injury to health or the environment, shall be considered to be a final agency action, effective beginning on the date of promulgation of the final rule. For the purposes of this Act, the term requirement as used in this section shall not displace statutory or common law. .
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Sec. 6
Prioritization, risk evaluation, and regulation of chemical substances and mixtures
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