Sec. 7. Batching, categorization, prioritization, safety standard determination, and risk management
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/bill/113/s/696/is/section-7A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 6 of the Toxic Substances Control Act ( 15 U.S.C. 2605 ) is amended— by striking subsection (f); by redesignating subsection
(e)as subsection (i); by striking the section heading and designation and all that follows through subsection
(d)and inserting the following: To ensure that an efficient and orderly process and pace is established for the determination of safety of chemical substances in commerce and the application of risk management measures as needed, the Administrator shall establish a system for assigning chemical substances into batches in accordance with this subsection. Not later than 270 days after the date of enactment of the Safe Chemicals Act of 2013 , and not less frequently than once every 5 years thereafter until all chemical substances listed on the active portion of the inventory established under section 8(h)(1) have been assigned to a batch, the Administrator shall assign chemical substances on the active portion of the inventory to batches of chemical substances under this subsection. Each batch established under this subsection shall include a number of chemical substances approximately equal to the number of chemical substances for which reports are submitted to the Administrator under the chemical data reporting rule as of the date of enactment of the Safe Chemicals Act of 2013 . The Administrator shall publish, subject to section 14, the list of chemical substances assigned to each batch promptly on designation of the chemical substances to the batch. Subject to subparagraph (B), the initial batch of chemical substances designated under paragraph (2)(A) shall include the chemical substances for which reports are submitted to the Administrator under the chemical data reporting rule as of the date of enactment of the Safe Chemicals Act of 2013 . Notwithstanding subparagraph (A), the Administrator may— include in the initial batch chemical substances that— are manufactured at volumes below the threshold used under the chemical data reporting rule to designate chemical substances subject to basic reporting under that rule; but are used or released into the environment in a manner that the Administrator determines warrants early evaluation; and exclude from the initial batch chemical substances that— are reported to the Administrator under the chemical data reporting rule; but are used or released into the environment in a manner that the Administrator determines does not warrant early evaluation. The Administrator shall assign chemical substances to subsequent batches in a manner that the Administrator determines reflects the extent to which the chemical substances warrant earlier or later evaluation. Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall promulgate regulations that— establish the categories and specify the process and criteria the Administrator will use to categorize chemical substances, which shall be consistent with paragraph (3)(B), beginning with those chemical substances assigned to the initial batch described in subsection (a)(3); designate the process and criteria the Administrator will use to prioritize chemical substances that are placed in the category of chemical substances to undergo safety standard determinations, which shall be consistent with the priorities described in paragraph (4); describe how the categorization and prioritization process and criteria relate to, and take into account, the categorization and prioritization decisions made in other jurisdictions, including States and foreign governments; and describe criteria and factors the Administrator will use to weigh evidence and assess the quality and reliability of information used to inform categorization and prioritization decisions. In making categorization and prioritization decisions, the Administrator shall take into consideration information regarding chemical substances that is available to the Administrator at the time the decisions are made, including information that is— received by the Administrator from manufacturers or processors pursuant to requirements under section 8(b) and (c); included in any minimum information set required under section 4; submitted to the Administrator that is relevant to the categorization or prioritization of the chemical substance; and identified through an active search by the Administrator of information sources that are publicly available or otherwise accessible to the Administrator. Subject to clause (ii), on designation by the Administrator under paragraph (3)(B)(iii) of a chemical substance safety standard determination, any manufacturer or processor of a designated chemical substance and any trade association or voluntary consortium that represents a manufacturer or processor of a designated chemical substance may provide to the Administrator information that— relates to the chemical substances manufactured or processed by the applicable manufacturer or processor; is in the possession of, or known to, the manufacturer, processor, trade association, or consortium; and is not already available to the Administrator. If a manufacturer, processor, trade association, or consortium elects to provide information to the Administrator under clause (i), the manufacturer, processor, trade association, or consortium shall provide all relevant information in the possession of, or known to, the manufacturer, processor, trade association, or consortium for each chemical substance designated by the Administrator that is manufactured or processed by the applicable manufacturer or processor. Information described in this subparagraph may be submitted to the Administrator by— a manufacturer or processor— on an individual basis; or through a trade association or voluntary consortium; and a trade association or voluntary consortium that has developed relevant information on behalf of the manufacturers or processors of designated chemical substances represented by the trade association or voluntary consortium. Not later than 180 days after the date of promulgation of regulations pursuant to paragraph (1), the Administrator shall publish, subject to section 14, the category assignments for the initial batch of chemical substances identified under subsection (a)(3), using the categories described in subparagraph (B). Not later than 180 days after the date on which the Administrator designates each subsequent batch of chemical substances under subsection (a)(2)(A), the Administrator shall publish the category assignments for the chemical substances in the batch. The regulation promulgated pursuant to paragraph
(1)shall incorporate, establish criteria for, and further specify as needed, the following categories into which chemical substances in each batch shall be placed: The Administrator shall designate as substances of very high concern those chemical substances— for which there is evidence of widespread exposure and that— are toxic, persist in the environment, and are bioaccumulative; or are highly hazardous; or that are subject to regulation under section 6 or 7 of this Act (as in effect on the day before the date of enactment of the Safe Chemicals Act of 2013 ). A minimum information set, as specified under section 4, need not be submitted or otherwise available for a chemical substance to be designated a substance of very high concern under this clause. The Administrator shall designate as substances of very low concern those chemical substances that, based on robust information, the Administrator determines possess intrinsic low-hazard properties such that no further action by the Administrator is warranted, unless the Administrator receives new information that warrants a different categorization of the chemical substance. In designating chemical substances to be placed in the very low concern category under this clause, the Administrator shall— take into consideration whether chemical substances in commerce have received, as of the date of enactment of the Safe Chemicals Act of 2013 , exemptions under section 5 of this Act (as in effect on the day before the date of enactment of the Safe Chemicals Act of 2013 ) based on anticipated low intrinsic hazard; and in general, base the designation on a minimum information set as required under section 4, unless the Administrator determines that such designation of a particular chemical substance— can be made to a high degree of confidence based on less information; or requires information in addition to the full minimum information set to address conflicting or ambiguous findings, in which case the Administrator may require the development and submission of the additional information. The Administrator shall designate as substances to undergo safety standard determinations those chemical substances that the Administrator determines— based on a screening of available use, hazard, and exposure information, do not meet the criteria for the categories described in clauses
(i)and (ii); and are the subject of available information that is sufficiently robust to inform prioritization decisions to be made for the chemical substances under paragraph (4). The Administrator shall designate as substances with insufficient information those chemical substances for which the Administrator determines, after gathering and screening available use, hazard, and exposure information, that information is not available, is insufficient, or is not of sufficient quality and reliability to allow for an informed categorization decision. For chemical substances designated under this clause, the Administrator shall require submission of the applicable minimum information set specified under section 4 as needed to inform categorization decisionmaking. The minimum information set shall be submitted to the Administrator— not later than 5 years after the date of enactment of the Safe Chemicals Act of 2013 for the initial batch of chemical substances identified under subsection (a)(3); and not later than 5 years after the assignment of a chemical substance to the category under this clause for subsequent batches. After submission of the minimum information set for a chemical substance pursuant to subclause (I), the Administrator shall recategorize the chemical substance using the categories and process described in this paragraph. The Administrator, taking into account the timing of the submission and workload considerations, may— add a chemical substance to a current batch; or hold the chemical substance until the next batch of chemical substances for recategorization. A chemical substance shall not be simultaneously in more than 1 of the categories designated under clause
(i)through (iv). Not later than 270 days after the date of promulgation of regulations pursuant to paragraph (1), the Administrator shall publish, subject to section 14, the priority class assignments, using the priority classes described in subparagraph (B), for the chemical substances in the initial batch of chemical substances identified under subsection (a)(3) that the Administrator has assigned to the category of chemical substances to undergo safety standard determinations. Not later than 270 days after the date on which the Administrator designates each subsequent batch of chemical substances under subsection (a)(2)(A), the Administrator shall publish the priority class assignments for the chemical substances in the batch that the Administrator has assigned to the category of chemical substances to undergo safety standard determinations. The criteria used by the Administrator to assign chemical substances to priority classes shall take into account— potential impacts of the chemical substance on human health and the environment; the hazard potential of the chemical substance, including classifications and designations of hazard characteristics by other authoritative entities; the potential for exposure to the chemical substance; and measurements of exposure for a given pathway of exposure, if available and reliable, in preference to less direct indicators of, or surrogates for, exposure potential for the same pathway. The regulations promulgated pursuant to paragraph
(1)shall establish the following priority classes and criteria, and further specify the process the Administrator will use to assign to the priority classes the chemical substances in each batch that the Administrator has assigned to the category of chemical substances to undergo safety standard determinations: In each batch, the Administrator shall designate as Priority Class 1 those chemical substances that the Administrator determines warrant safety standard determinations in the near term. The Administrator shall in each batch initially designate as Priority Class 1 chemical substances that possess relatively greater hazard potential and for which there is evidence of more significant or widespread exposure. As safety standard determinations for the chemical substance are completed, the Administrator may designate as Priority Class 1 any chemical substance initially assigned to a lower priority class, including chemical substances— posing significant hazard concerns but of less or unknown exposure concern; posing significant exposure concern but of less or unknown hazard concern; or posing less hazard and exposure concerns. In determining the number of chemical substances to be placed in Priority Class 1, the Administrator shall seek to balance considerations relating to— the number of chemical substances for which safety standard determinations need to be conducted; the resources available to the Administrator for conducting safety standard determinations; and the deadlines for completion of safety standard determinations specified in subsection (d)(4). The Administrator shall designate as Priority Class 2 those chemical substances that the Administrator determines are of lower priority than Priority Class 1 substances with respect to the timing for conducting safety standard determinations. For chemical substances designated under this clause, the Administrator shall require submission of the applicable minimum information set specified under section 4 as needed to inform prioritization decisionmaking. The minimum information set shall be submitted to the Administrator— not later than 5 years after the date of enactment of the Safe Chemicals Act of 2013 for chemical substances in the initial batch identified under subsection (a)(3) that are assigned to Priority Class 2; and not later than 5 years after the assignment of a chemical substance to Priority Class 2 under this clause for subsequent batches. After submission of the minimum information set for a chemical substance under subclause (II), the Administrator shall, if warranted, recategorize or otherwise reprioritize the chemical substance using the priority classes and process described in this paragraph, together with other chemical substances in the batch undergoing prioritization at the time of the submission. As safety standard determinations are completed on Priority Class 1 chemical substances pursuant to subsection (d), the Administrator shall reprioritize Priority Class 2 substances as Priority Class 1 at a pace consistent with— the resources available to the Administrator for conducting safety standard determinations; and the deadlines for completion of safety standard determinations specified in subsection (d)(4). The Administrator shall designate as Priority Class 3 those chemical substances that the Administrator determines may be set aside for further assessment until such time as— safety standard determinations are completed on all Priority Class 1 and 2 substances; or new information arises that warrants reprioritization of such a substance to a higher priority class. For a chemical substance designated under this clause, the Administrator shall not require submission of the applicable minimum information set specified under section 4 until such time as the chemical substance is reassigned to Priority Class 1 or 2. On reassignment of a chemical substance to Priority Class 1 or 2 under item (aa), the minimum information set shall be submitted to the Administrator not later than 5 years after the date of the reassignment. After submission of the minimum information set for a chemical substance pursuant to subclause (II), the Administrator shall reprioritize the chemical substance using the priority classes and process described in this paragraph, together with chemical substances in the batch undergoing prioritization at the time of the submission. In conjunction with the reprioritization by the Administrator of Priority Class 2 substances as Priority Class 1, the Administrator shall reprioritize Priority Class 3 substances as Priority Class 1 or 2, at a pace consistent with— the resources available to the Administrator for conducting safety standard determinations; and the deadlines for completion of safety standard determinations specified in subsection (d)(4). The designation by the Administrator of batches of chemical substances pursuant to subsection (a), the assignment of chemical substances to categories pursuant to subsection (b)(3), and the assignment of chemical substances to priority classes pursuant to subsection (b)(4), including any determination of the Administrator to include a specific chemical substance in, or exclude a specific chemical substance from, a designated batch, category, or priority class under this section, shall not be— considered to be a final agency action for the purpose of subchapter II of chapter 5, and chapter 7, of title 5, United States Code (commonly known as the Administrative Procedure Act ); or subject to judicial review. A failure by the Administrator to designate or publish a list of chemical substances assigned to a batch, category, or priority class in accordance with this subsection shall be— considered to be a failure to perform a nondiscretionary duty; and subject to judicial review. This paragraph applies to any determination or redetermination regarding whether a chemical substance meets the safety standards of this Act. For purposes of this Act, each manufacturer and processor of a chemical substance shall at all times bear the burden of proof in any legal proceeding relating to a decision of the Administrator regarding whether the chemical substance meets the safety standard. For purposes of this Act— it shall be the duty of the manufacturer or processor of a chemical substance to provide sufficient information for the Administrator to determine whether the chemical substance meets the safety standard; and it shall be the duty of the Administrator to determine whether a chemical substance meets the safety standard. A chemical substance that undergoes a safety standard determination under this section may be manufactured, processed, or distributed in commerce only if the Administrator determines that the chemical substance— meets the safety standard, taking into account any existing conditions or controls already in effect; or can meet the safety standard for all or some uses through the imposition of additional conditions. Any assessment of risk used to support a determination that a chemical substance meets the safety standard under clause
(i)shall be conducted by employees of the Environmental Protection Agency who are competent to conduct such assessments. The Administrator shall base a determination of whether a safety standard for a chemical substance has been met under subparagraph
(A)solely on considerations of human health and the environment, including the health of vulnerable populations. In making a safety standard determination under this subsection, for each chemical substance, the Administrator shall— to the extent practicable, review and incorporate any available scientific information relating to the effect of cumulative exposure relevant to that chemical substance on human health and the environment; and find that a chemical substance meets the safety standard only if the Administrator finds that there is a reasonable certainty that no harm will result to human health or the environment from aggregate exposure to the chemical substance. No person conducting an assessment described in subparagraph (A), or a peer review of such an assessment, may have a direct or indirect financial interest in the outcome of the assessment. Subject to clause (ii), the Administrator shall use the best available science when conducting an assessment described in subparagraph (A). For the purpose of determining the current best available science the Administrator shall base the determination on the recommendations of the National Academy of Sciences in the report entitled Science and Decisions . Not later than 5 years after the date of enactment of the Safe Chemicals Act of 2013 , and not less frequently than once every 5 years thereafter, the Administrator shall review the methodology under this paragraph and may revise the methodology to reflect new scientific developments or understandings. An assessment described in subparagraph
(A)shall address health or environmental impacts including potential or demonstrated cancer and noncancer endpoints. In carrying out this subsection, the Administrator shall ensure that the approaches and resulting assessments are communicated in a manner that is transparent and understandable to— the public; and risk managers. In the case of a chemical substance that is manufactured or processed in whole or in part for export, in determining whether the chemical substance meets the safety standard under subparagraph (A)(i), the Administrator shall take into account any risk— that the chemical substance may pose in the United States, including risks involving long-range transport of the chemical substance in the environment; or involving the import of articles and mixtures containing the chemical substance. The Administrator shall not be required to conduct a risk assessment to determine that a manufacturer or processor has not met the burden of proof under paragraph (1)(B). A determination by the Administrator that a manufacturer or processor has not established that the chemical substance meets the applicable safety standard under this subsection shall not be subject to judicial review. In making a safety standard determination with respect to a chemical substance, the Administrator— shall take into consideration information regarding the chemical substance that is already available to the Administrator at the time the determination is to be made, including information— received by the Administrator from manufacturers or processors under this section or section 8; contained in any minimum information sets previously required under section 4; voluntarily submitted by manufacturers and processors in accordance with subsection (b)(2)(B); submitted by any other party to the Administrator that is relevant to the conduct of a safety standard determination of the chemical substance; or identified through an active search by the Administrator of information sources that are publicly available or otherwise accessible to the Administrator; shall require information needed to complete the applicable minimum information set for the chemical substance required under section 4(a); may require, by regulation or order pursuant to section 4(b) or 8(e), manufacturers or processors of the chemical substance to develop and submit any additional information the Administrator determines is needed to conduct the safety standard determination of the chemical substance; and shall take into consideration, but not rely on, assessments of safety or analyses of the effectiveness of existing control measures— submitted to the Administrator by any party; or conducted by a governmental entity in another jurisdiction. Beginning with chemical substances initially designated as Priority Class 1 under subsection (b)(4)(C)(i), the Administrator shall conduct safety standard determinations of all chemical substances assigned to the category of substances to undergo safety standard determinations pursuant to subsection (b)(3)(B)(iii). Not later than 5 years after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall complete and publish safety standard determinations for all chemical substances designated as Priority Class 1 substances in the initial batch of chemical substances identified under subsection (a)(3). Not later than 5 years after the date on which the Administrator designates chemical substances as Priority Class 1 in each subsequent batch of chemical substances under subsection (a)(2)(A), the Administrator shall complete and publish safety standard determinations for those Priority Class 1 substances in the batch. Each chemical substance initially designated as Priority Class 2 or 3 shall become subject to reprioritization and safety standard determinations in accordance with subsection (b)(4). Not later than 5 years after the date on which the Administrator designates a Priority Class 2 or 3 substance to be Priority Class 1, the Administrator shall complete and publish the safety standard determination on the chemical substance. If the Administrator fails to act by an applicable deadline under subparagraph
(A)or (B), each manufacturer and processor of a chemical substance for which the Administrator has failed to act shall provide to the Administrator, the public, employees and recognized bargaining agents of any employees who are represented by bargaining agents of the manufacturer or processor, and each known customer who has purchased the chemical substance within a reasonable timeframe, as determined by the Administrator by regulation or order, a written notice that a determination by the Administrator of the safety of the chemical substance is pending. If a manufacturer or processor fails to meet any duty under this paragraph for a chemical substance, the Administrator, by order, may take any action authorized under subsection (f). In making a safety standard determination for a chemical substance, the Administrator, by order, shall determine or redetermine, as appropriate, whether the manufacturers and processors of the chemical substance have established that the chemical substance meets the safety standard. The Administrator— shall seek to publish safety standard determination and risk management decisions concurrently, to the maximum extent practicable; but shall not unduly delay the issuance of any safety standard determination if more information or analysis is required to make a determination regarding risk management. The Administrator— may publish safety standard determinations for chemical substances individually or in groups; but shall publish completed determinations— not less frequently than annually; and at a pace sufficient to demonstrate steady progress toward completing all such safety standard determinations within the required timeframe. The Administrator shall provide reasonable public notice and opportunity for comment on all published safety standard determinations through any reasonable means of publication and solicitation of comments, including electronic means. If the Administrator determines that a chemical substance meets the safety standard for all current uses and under conditions currently used, the Administrator shall specify in the order— the allowed uses of the chemical substance, which shall be limited to the uses evaluated in the determination; and conditions on the specified uses that are currently used and are to be followed to ensure the safety standard is met, including conditions relating to the manufacture, processing, use, distribution in commerce, or disposal of a chemical substance or mixture or article containing the chemical substance. If the Administrator determines that a chemical substance can only meet the safety standard for a subset of all current uses or only under conditions beyond those currently used, the Administrator shall specify in the order— the allowed uses of the chemical substance, which shall be limited to the uses evaluated in the determination that the Administrator determines meet the safety standard; and all current and all newly required conditions on the specified uses needed to ensure the safety standard is met, including conditions relating to the manufacture, processing, use, distribution in commerce, or disposal of a chemical substance or mixture or article containing the chemical substance, and any conditions described in subsection (f). Effective beginning on the date that is 90 days after the date of a determination by the Administrator under subparagraph (B), no person shall manufacture, process, or distribute in commerce the chemical substance subject to the determination, or any mixture or article containing the chemical substance, for any use or under any condition other than those specified in the determination order. Effective beginning on the date that is 18 months after the date of a determination by the Administrator under subparagraph (C), except as provided in clause (iii), no person shall manufacture, process, or distribute in commerce the chemical substance subject to the determination, or any mixture or article containing the chemical substance, for any use or under any condition other than those specified in the determination order. The Administrator may grant a manufacturer or processor of a chemical substance a 1-time extension of the deadline for complying with a restriction under clause (ii), for a period of not longer than 5 years after the date of the determination by the Administrator under subparagraph (C), if the manufacturer or processor demonstrates— a compelling technological need to continue a restricted activity beyond the applicable 18-month time period; or that a factor wholly beyond the control of the manufacturer or processor prevents compliance with the restriction within that 18-month time period. The Administrator shall initiate a redetermination of whether a chemical substance meets the safety standard if new information or significant changes in manufacture, processing, use, or distribution in commerce of the chemical substance, or mixtures or articles containing the chemical substance, raise a credible question as to whether the chemical substance continues to meet the safety standard. The Administrator may initiate a redetermination of whether a chemical substance meets the safety standard if significant changes have occurred in the methodologies used in the initial safety standard determination such that a redetermination using the newer methodologies would provide a significantly improved determination of the safety of the chemical substance. For a chemical substance for which a safety standard determination has been completed, the Administrator shall assess, on an ongoing basis, new information, including that obtained from reporting under section 8, to decide whether such information raises a credible question as to whether a chemical substance continues to meet the safety standard. Any person may petition the Administrator for a redetermination of whether a chemical substance continues to meet the safety standard. A person shall include in a petition under this clause a description of the basis for requesting the redetermination. On receipt of a petition under this clause, the Administrator shall— not later than 30 days after the date of receipt, publish in the Federal Register a notice of receipt of the petition that specifies the chemical identity of the chemical substance to which the petition pertains; make the petition available on request; provide a reasonable opportunity for public review and comment on the petition and give due consideration to any comments received; decide whether to make the requested redetermination; and not later than 180 days after the date of receipt, publish in the Federal Register the decision and the basis for the decision. Each redetermination carried out under this subparagraph shall be completed by not later than 3 years after the date of the decision to make the redetermination. Except as provided in clause
(ii)and subsection (h), effective beginning on the date that is 18 months after the date on which the Administrator makes a determination under this subsection that a chemical substance fails to meet the safety standard, regardless of whether additional restrictions on use or risk management conditions are imposed, no person shall manufacture, process, or distribute in commerce that chemical substance or any mixture or article containing the chemical substance. The Administrator may grant a manufacturer or processor of a chemical substance a 1-time extension of the deadline for complying with the restriction under clause (i), for a period of not longer than 5 years after the date of the determination by the Administrator under this subparagraph, if the manufacturer or processor demonstrates— a compelling technological need to continue a restricted activity beyond the applicable 18-month time period; or that a factor wholly beyond the control of the manufacturer or processor prevents compliance with the restriction within that 18-month time period. Not later than 180 days after the date on which a chemical substance is assigned to the category of substances of very high concern under subsection (b)(3)(B)(i), the Administrator may require, by order pursuant to section 8(g), the submission by manufacturers or processors of the chemical substance of any additional information the Administrator determines to be necessary to conduct an expedited assessment of the known uses of, and exposures to, the chemical substance. Not later than 1 year after the date on which a chemical substance is assigned to the category of substances of very high concern under subsection (b)(3)(B)(i), the Administrator shall complete and publish an identification and assessment of the known uses of, and exposures to, the chemical substance. As soon as practicable, but not later than 18 months, after the date on which a chemical substance is assigned to the category of substances of very high concern under subsection (b)(3)(B)(i), the Administrator shall impose, by order, use restrictions and other conditions, including the conditions specified in subsection (f), on the manufacturing, processing, use, distribution in commerce, and disposal of the chemical substance that the Administrator determines to be necessary to achieve the maximum practicable reduction in human or environmental exposure to the chemical substance. Except as provided in subparagraph
(C)and subsection (h), effective beginning on the date that is 18 months after the date of issuance by the Administrator of the order described in subparagraph (A), no person shall manufacture, process, or distribute in commerce the chemical substance subject to the determination, or any mixture or article containing the chemical substance, for any use or under any condition other than those specified in the order issued under subparagraph (A). The Administrator may grant a manufacturer or processor of a chemical substance a 1-time extension of the deadline for complying with the restriction under subparagraph (B), for a period of not longer than 5 years after the date of the determination by the Administrator under this paragraph, if the manufacturer or processor demonstrates— a compelling technological need to continue a restricted activity beyond the applicable 18-month time period; or that a factor wholly beyond the control of the manufacturer or processor prevents compliance with the restriction within that 18-month time period. Not later than 1 year after the deadline specified in paragraph (2)(B), or of an alternative deadline provided under paragraph (2)(C), the Administrator shall— determine whether the chemical substance meets the safety standard for the chemical substance, taking into account the residual risk posed by continued exposure to the chemical substance; and impose any additional restrictions on use or other conditions under subsection
(f)that the Administrator determines to be necessary to ensure that the chemical substance meets the safety standard. In issuing an order under subsection
(d)or (e), the Administrator may impose conditions on the manufacture, processing, use, distribution in commerce, or disposal of a chemical substance, or mixture or article containing a chemical substance, including a requirement— limiting the quantity of the chemical substance (or mixture or article containing that chemical substance) that may be manufactured, processed, or distributed in commerce; prohibiting the manufacturing, processing, or distribution in commerce of the chemical substance (or mixture or article containing that chemical substance) for a particular use in a concentration in excess of a level specified by the Administrator; or limiting the quantity of the chemical substance (or mixture or article containing that chemical substance) that may be manufactured, processed, or distributed in commerce for— a particular use; or a particular use in a concentration in excess of a level specified by the Administrator; that the chemical substance (or mixture, or article containing that chemical substance) be marked with, or accompanied by, clear and adequate warnings and instructions with respect to use, distribution in commerce, or disposal, or any combination of such activities, with the form and content of the warnings and instructions prescribed by the Administrator; that manufacturers and processors of the chemical substance (or mixture or article containing that chemical substance)— make and retain records of the processes used to manufacture or process the chemical substance (or mixture or article containing that chemical substance); and monitor or conduct tests that are reasonable and necessary to ensure compliance with this Act; prohibiting or otherwise regulating any manner or method of commercial use of the chemical substance (or mixture or article containing that chemical substance); prohibiting or otherwise regulating any manner or method of disposal of the chemical substance, mixture, or article, by— the manufacturer or processor of the chemical substance (or mixture or article containing that chemical substance); or any other person that uses or disposes of the chemical substance (or mixture or article containing that chemical substance) for commercial purposes; that the manufacturers and processors of the chemical substance, mixture, or article develop a risk reduction management plan, under subsection
(h)or
(e)of this section, to achieve a risk reduction specified by the Administrator; or that the Administrator otherwise determines is appropriate. If the Administrator has a reasonable basis to conclude that a particular manufacturer or processor is manufacturing or processing a chemical substance in a manner that may present a substantial endangerment to health or the environment, the Administrator may require, by order, that the manufacturer or processor submit to the Administrator a description of the quality control procedures followed in the manufacturing or processing of the chemical substance or mixture. If the Administrator determines that quality control procedures described in paragraph
(1)are inadequate to prevent a chemical substance from presenting a risk of injury to human health or the environment, the Administrator may order the manufacturer or processor to revise the quality control procedures to the extent necessary to remedy the inadequacy. If the Administrator determines that quality control procedures described in paragraph
(1)have resulted in the distribution in commerce of a chemical substance that may present a substantial endangerment to human health or the environment, the Administrator may order the manufacturer or processor— to give notice of the endangerment to— processors or distributors (or both) in commerce of the chemical substance or mixture; and to the extent reasonably ascertainable, any other person in possession of or exposed to the chemical substance or mixture; to give public notice of the endangerment; and to provide for the replacement or repurchase, as prescribed by the Administrator, of the chemical substance as the Administrator determines to be necessary to adequately protect human health or the environment. This subsection applies to the restrictions established under section 5(b)(1)(C)(ii)(I), subsection (d)(5), and subsections
(e)and (f). A person who manufacturers, processes, distributes in commerce, uses, or disposes of a chemical substance, or a mixture or article containing a chemical substance may request an exemption from any restriction referred to in paragraph
(1)to which they are subject for a specified use of the chemical substance. The Administrator may grant, by order, an exemption from any restriction referred to in paragraph
(1)for a period of not longer than 5 years if the person has established by clear and convincing evidence that the uses to be exempted meet the exemption criteria described in subparagraph (B). The Administrator may grant an exemption for the use of a chemical substance under subparagraph (A)(ii) if— the exemption is in the paramount interest of national security; the lack of availability of the chemical substance would cause significant disruption in the national economy; or the use for which the exemption is sought is a critical or essential use for which— no feasible safer alternative for the specified use of the chemical substance is available; or the specified use of the chemical substance, as compared to all available alternatives, provides a substantial net benefit to human health, the environment, or public safety. If the Administrator grants an exemption for a chemical substance under this paragraph— the manufacturer or processor of the chemical substance shall provide a notice of the exemption to each known purchaser of— the chemical substance; and a mixture or article containing the chemical substance; and the Administrator shall provide the public with a notice of the exemption. The Administrator may renew, by order, an exemption under this paragraph for 1 or more additional 5-year periods if the Administrator concludes, after providing public notice and an opportunity for comment, that the use of the chemical substance continues to meet the criteria described in subparagraph (B). The Administrator may impose, by order, any condition on an exemption issued under this paragraph that the Administrator determines to be necessary to ensure the protection of human health and the environment on the use of a chemical substance exempted under this paragraph. Effective immediately after the Administrator establishes conditions on an exempted use under clause (i), the manufacturing, processing, or distribution in commerce of the chemical substance, or any mixture or article containing the chemical substance, shall be prohibited except to the extent that the conditions are satisfied. Any restriction referred to in paragraph
(1)that would otherwise be applicable to the sale or lease of an article shall not apply to— the sale of an article that was previously purchased by an end consumer; or the lease of an article that was purchased by the lessor subsequent to the manufacture of the article. Except as provided in subparagraph (B), in the case of the retail sale to an end consumer of a chemical substance (or mixture or article containing that chemical substance) that is subject to a restriction described in paragraph (1), the Administrator may extend, by order, the effective date of the restriction by a period of not longer than 3 years, if the Administrator determines that the extension— is necessary and appropriate to allow for depletion of the existing retail inventory; and will not present a substantial endangerment to human health or the environment. An extension under subparagraph
(A)shall not apply to any retailer that the Administrator determines has failed to comply with an order requesting information issued by the Administrator pursuant to section 8. ; in subsection
(i)(as redesignated by paragraph (2))— by striking paragraph (4); and by redesignating paragraph
(5)as paragraph (4); and by inserting after subsection
(i)(as redesignated by paragraph (2)) the following: Except as provided in paragraph (2), no Federal agency shall convey, sell, or distribute to any other Federal agency, any State or local government agency, or any private individual or entity any elemental mercury, other than mercury contained within an article, under the control or jurisdiction of the Federal agency. Paragraph
(1)shall not apply to— a transfer between Federal agencies of elemental mercury for the sole purpose of facilitating storage of mercury to carry out this Act; or a conveyance, sale, distribution, or transfer of coal. Nothing in this subsection prohibits the leasing of coal. Not later than 90 days after the enactment of the Safe Chemicals Act of 2013 , the Administrator shall designate asbestos as a chemical substance of very high concern under subsection (b)(3)(B)(i). Not later than 90 days after the date on which asbestos is assigned to the category of substances of very high concern under subsection (b)(3)(B)(i), the Administrator shall complete and publish an identification and assessment of the known uses of, and exposures to asbestos. As soon as practicable, but not later than 12 months after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall impose, by order, use restrictions and other conditions, including the conditions specified in subsection
(f)on the manufacturing, processing, use, distribution in commerce, and disposal of asbestos that the Administrator determines to be necessary to achieve the maximum practicable reduction in human or environmental exposure to asbestos. The Administrator shall select conditions that permanently reduce or eliminate the possibility of exposures to the maximum extent practicable. Except as provided in clauses
(i)and
(ii)of subsection (h)(2)(B), effective beginning on the date that is 12 months after the date of issuance by the Administrator of the order described in subparagraph (C), no person shall manufacture, process, or distribute in commerce asbestos subject to the determination, or any mixture or article containing asbestos, for any use or under any condition other than those specified in the order issued under subparagraph (C). Not later than 180 days after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator, in consultation with the Director of the National Institutes of Occupational Safety and Health, shall publish draft guidance describing the steps that Federal agencies and contractors of Federal agencies shall take to enhance protections for public health and safety and the environment, and to better solicit information from members of the public who may potentially be affected by asbestos, when Federal agencies and contractors of Federal Agencies handle or dispose of asbestos. The Administrator shall allow 30 days of public comment on this draft guidance and hold no fewer than two public meetings on this draft guidance in communities impacted by asbestos contamination. Not later than 12 months after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator, in consultation with the Director of the National Institutes of Occupational Safety and Health, shall publish final guidance describing the steps that Federal agencies and contractors of Federal Agencies shall take to enhance protections for public health and safety and the environment when handling and disposing of asbestos. The final guidance shall also include steps that shall be taken to better solicit information from and protect the health and safety of people located near areas where asbestos is located, where asbestos is transported, and where asbestos disposal occurs. For purposes of this section, the term asbestos has the meaning given such term under section 202(3). Nothing in paragraph
(2)or any amendment made by paragraph
(2)shall be construed to affect or limit the application of or obligation to comply with any environmental law, including the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 ( 42 U.S.C. 9601 et seq. ). Each submission required under this section (or a regulation or order promulgated or issued by the Administrator pursuant to this section) shall be accompanied by a certification signed by a responsible official of the manufacturer or processor that each statement contained in the submission— is accurate and reliable; and includes all material facts required by the applicable provision of this section or rule or order under this section. In any regulation or order under this section, the Administrator shall specify the date on which the regulation or order shall take effect, which date shall be as soon as practicable after the date of promulgation or issuance of the regulation or order. . Section 202(3) of the Toxic Substances Control Act (15 U.S.C. 2642(3)) is amended— in subparagraph (E), by striking or ; in subparagraph (F), by striking the period at the end and inserting , and ; and by adding at the end the following any material formally classified as tremolite, including— winchire asbestos, and richterite asbestos, and any asbestiform amphibole mineral. .
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Sec. 7
Batching, categorization, prioritization, safety standard determination, and risk management
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