15 U.S.C. § 2605 — Prioritization, risk evaluation, and regula-

Page 1864 TITLE 15—COMMERCE AND TRADE § 2605 shall apply with respect to an injunction issued under subparagraph (B)’’ after ‘‘subparagraph (A)’’, and struck out former subpar. (B) which read as follows: ‘‘If the district court of the United States to which an ap- plication has been made under subparagraph (A)(ii) finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance with respect to which such application was made, or that any com- bination of such activities, presents or will present an unreasonable risk of injury to health or the environ- ment before a rule promulgated under section 2605 of this title can protect against such risk, the court shall issue an injunction to prohibit the manufacture, proc- essing, or distribution in commerce of such substance or to prohibit any combination of such activities.’’ Subsec. (f)(3)(D). Pub. L. 114–182, § 5(6)(C)(iv), struck out subpar. (D) which read as follows: ‘‘If the Adminis- trator issues an order pursuant to subparagraph (A)(i) respecting a chemical substance and objections are filed in accordance with subsection (e)(1)(C), the Ad- ministrator shall seek an injunction under subpara- graph (A)(ii) respecting such substance unless the Ad- ministrator determines, on the basis of such objections, that such substance does not or will not present an un- reasonable risk of injury to health or the environ- ment.’’ Subsec. (f)(4), (5). Pub. L. 114–182, § 5(6)(D), added pars. (4) and (5). Subsec. (g). Pub. L. 114–182, § 5(7), amended subsec. (g) generally. Prior to amendment, text read as follows: ‘‘If the Administrator has not initiated any action under this section or section 2605 or 2606 of this title to pro- hibit or limit the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance, with respect to which notification or data is required by subsection (a)(1)(B) or (b), before the expiration of the notification period applicable to the manufacturing or processing of such substance, the Administrator shall publish a statement of the Administrator’s rea- sons for not initiating such action. Such a statement shall be published in the Federal Register before the expiration of such period. Publication of such state- ment in accordance with the preceding sentence is not a prerequisite to the manufacturing or processing of the substance with respect to which the statement is to be published.’’ Subsec. (h)(1)(A). Pub. L. 114–182, § 5(8)(A), inserted ‘‘, including an unreasonable risk to a potentially ex- posed or susceptible subpopulation identified by the Administrator for the specific conditions of use identi- fied in the application’’ after ‘‘health or the environ- ment’’. Subsec. (h)(2). Pub. L. 114–182, § 5(8)(B), substituted ‘‘information’’ for ‘‘data’’ wherever appearing. Subsec. (h)(4). Pub. L. 114–182, § 5(8)(C), substituted ‘‘environment, including an unreasonable risk to a po- tentially exposed or susceptible subpopulation identi- fied by the Administrator under the conditions of use’’ for ‘‘environment. A rule promulgated under this para- graph (and any substantive amendment to, or repeal of, such a rule) shall be promulgated in accordance with paragraphs (2) and (3) of section 2605(c) of this title’’. Subsec. (i). Pub. L. 114–182, § 5(9), amended subsec. (i) generally. Prior to amendment, text read as follows: ‘‘For purposes of this section, the terms ‘manufacture’ and ‘process’ mean manufacturing or processing for commercial purposes.’’ Statutory Notes and Related Subsidiaries EFFECTIVE DATE Section effective Jan. 1, 1977, see section 31 of Pub. L. 94–469, set out as a note under section 2601 of this title. § 2605. Prioritization, risk evaluation, and regula- tion of chemical substances and mixtures (a) Scope of regulation If the Administrator determines in accordance with subsection (b)(4)(A) that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance or mixture, or that any combination of such activities, pre- sents an unreasonable risk of injury to health or the environment, the Administrator shall by rule and subject to section 2617 of this title, and in accordance with subsection (c)(2), apply one or more of the following requirements to such substance or mixture to the extent necessary so that the chemical substance or mixture no longer presents such risk: (1) A requirement (A) prohibiting or other- wise restricting the manufacturing, proc- essing, or distribution in commerce of such substance or mixture, or (B) limiting the amount of such substance or mixture which may be manufactured, processed, or distrib- uted in commerce. (2) A requirement— (A) prohibiting or otherwise restricting the manufacture, processing, or distribution in commerce of such substance or mixture for (i) a particular use or (ii) a particular use in a concentration in excess of a level speci- fied by the Administrator in the rule impos- ing the requirement, or (B) limiting the amount of such substance or mixture which may be manufactured, processed, or distributed in commerce for (i) a particular use or (ii) a particular use in a concentration in excess of a level specified by the Administrator in the rule imposing the requirement. (3) A requirement that such substance or mixture or any article containing such sub- stance or mixture be marked with or accom- panied by clear and adequate minimum warn- ings and instructions with respect to its use, distribution in commerce, or disposal or with respect to any combination of such activities. The form and content of such minimum warn- ings and instructions shall be prescribed by the Administrator. (4) A requirement that manufacturers and processors of such substance or mixture make and retain records of the processes used to manufacture or process such substance or mix- ture or monitor or conduct tests which are reasonable and necessary to assure compliance with the requirements of any rule applicable under this subsection. (5) A requirement prohibiting or otherwise regulating any manner or method of commer- cial use of such substance or mixture. (6)(A) A requirement prohibiting or other- wise regulating any manner or method of dis- posal of such substance or mixture, or of any article containing such substance or mixture, by its manufacturer or processor or by any other person who uses, or disposes of, it for commercial purposes. (B) A requirement under subparagraph (A) may not require any person to take any action which would be in violation of any law or re- quirement of, or in effect for, a State or polit- ical subdivision, and shall require each person subject to it to notify each State and political subdivision in which a required disposal may occur of such disposal. (7) A requirement directing manufacturers or processors of such substance or mixture (A) Page 1865 TITLE 15—COMMERCE AND TRADE § 2605 to give notice of such determination to dis- tributors in commerce of such substance or mixture and, to the extent reasonably ascer- tainable, to other persons in possession of such substance or mixture or exposed to such sub- stance or mixture, (B) to give public notice of such determination, and (C) to replace or re- purchase such substance or mixture as elected by the person to which the requirement is di- rected. Any requirement (or combination of require- ments) imposed under this subsection may be limited in application to specified geographic areas. (b) Risk evaluations (1) Prioritization for risk evaluations (A) Establishment of process Not later than 1 year after June 22, 2016, the Administrator shall establish, by rule, a risk-based screening process, including cri- teria 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 consid- eration of the hazard and exposure potential of a chemical substance or a category of chemical substances (including consider- ation of persistence and bioaccumulation, potentially exposed or susceptible sub- populations 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. (B) Identification of priorities for risk eval- uation (i) High-priority substances The Administrator shall designate as a high-priority substance a chemical sub- stance that the Administrator concludes, without consideration of costs or other nonrisk factors, may present an unreason- able risk of injury to health or the envi- ronment because of a potential hazard and a potential route of exposure under the conditions of use, including an unreason- able risk to a potentially exposed or sus- ceptible subpopulation identified as rel- evant by the Administrator. (ii) Low-priority substances The Administrator shall designate a chemical substance as a low-priority sub- stance if the Administrator concludes, based on information sufficient to estab- lish, without consideration of costs or other nonrisk factors, that such substance does not meet the standard identified in clause (i) for designating a chemical sub- stance a high-priority substance. (C) Information request and review and pro- posed and final prioritization designa- tion 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 proc- ess for such designations includes— (i) a requirement that the Administrator request interested persons to submit rel- evant 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 in- formation to be provided; (ii) a requirement that the Adminis- trator publish each proposed designation of a chemical substance as a high- or low- priority substance, along with an identi- fication of the information, analysis, and basis used to make the proposed designa- tions, and provide 90 days for public com- ment on each such proposed designation; and (iii) a process by which the Adminis- trator may extend the deadline in clause (i) for up to three months in order to re- ceive or evaluate information required to be submitted in accordance with section 2603(a)(2)(B) of this title, subject to the limitation that if the information avail- able 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 chem- ical substance as a high-priority sub- stance. (2) Initial risk evaluations and subsequent des- ignations of high- and low-priority sub- stances (A) Initial risk evaluations Not later than 180 days after June 22, 2016, the Administrator shall ensure that risk evaluations are being conducted on 10 chem- ical substances drawn from the 2014 update of the TSCA Work Plan for Chemical Assess- ments and shall publish the list of such chemical substances during the 180 day pe- riod. (B) Additional risk evaluations Not later than three and one half years after June 22, 2016, the Administrator shall ensure that risk evaluations are being con- ducted on at least 20 high-priority sub- stances and that at least 20 chemical sub- stances 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 con- ducted by the Administrator are drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments. (C) Continuing designations and risk evalua- tions The Administrator shall continue to des- ignate priority substances and conduct risk evaluations in accordance with this sub- section at a pace consistent with the ability of the Administrator to complete risk eval- uations in accordance with the deadlines under paragraph (4)(G). Page 1866 TITLE 15—COMMERCE AND TRADE § 2605 (D) Preference In designating high-priority substances, the Administrator shall give preference to— (i) chemical substances that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments as having a Persist- ence and Bioaccumulation Score of 3; and (ii) 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. (E) Metals and metal compounds In identifying priorities for risk evalua- tion and conducting risk evaluations of met- als and metal compounds, the Administrator shall use the Framework for Metals Risk As- sessment of the Office of the Science Advi- sor, Risk Assessment Forum, and dated March 2007, or a successor document that ad- dresses metals risk assessment and is peer reviewed by the Science Advisory Board. (3) Initiation of risk evaluations; designations (A) Risk evaluation initiation Upon designating a chemical substance as a high-priority substance, the Administrator shall initiate a risk evaluation on the sub- stance. (B) Revision The Administrator may revise the designa- tion of a low-priority substance based on in- formation made available to the Adminis- trator. (C) Ongoing designations The Administrator shall designate at least one high-priority substance upon the com- pletion of each risk evaluation (other than risk evaluations for chemical substances designated under paragraph (4)(C)(ii)). (4) Risk evaluation process and deadlines (A) In general The Administrator shall conduct risk eval- uations pursuant to this paragraph to deter- mine 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 Ad- ministrator, under the conditions of use. (B) Establishment of process Not later than 1 year after June 22, 2016, the Administrator shall establish, by rule, a process to conduct risk evaluations in ac- cordance with subparagraph (A). (C) Requirement The Administrator shall conduct and pub- lish risk evaluations, in accordance with the rule promulgated under subparagraph (B), for a chemical substance— (i) that has been identified under para- graph (2)(A) or designated under paragraph (1)(B)(i); and (ii) 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 Ad- ministrator in the rule promulgated under subparagraph (B), be subjected to a risk evaluation. (D) Scope The Administrator shall, not later than 6 months after the initiation of a risk evalua- tion, publish the scope of the risk evaluation to be conducted, including the hazards, expo- sures, conditions of use, and the potentially exposed or susceptible subpopulations the Administrator expects to consider, and, for each designation of a high-priority sub- stance, ensure not less than 12 months be- tween the initiation of the prioritization process for the chemical substance and the publication of the scope of the risk evalua- tion for the chemical substance, and for risk evaluations conducted on chemical sub- stances that have been identified under paragraph (2)(A) or selected under subpara- graph (E)(iv)(II) of this paragraph, ensure not less than 3 months before the Adminis- trator publishes the scope of the risk evalua- tion. (E) Limitation and criteria (i) Percentage requirements 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 chem- ical substances undergoing a risk evalua- tion under clause (ii) of subparagraph (C) is— (I) not less than 25 percent, if sufficient requests are made under clause (ii) of subparagraph (C); and (II) not more than 50 percent. (ii) Requested risk evaluations Requests for risk evaluations under sub- paragraph (C)(ii) shall be subject to the payment of fees pursuant to section 2625(b) of this title, and the Administrator shall not expedite or otherwise provide special treatment to such risk evaluations. (iii) Preference In deciding whether to grant requests under subparagraph (C)(ii), the Adminis- trator 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 signifi- cant impact on interstate commerce or health or the environment. (iv) Exceptions (I) Chemical substances for which re- quests have been granted under subpara- graph (C)(ii) shall not be subject to section 2617(b) of this title. (II) 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 Adminis- trator and not be subject to clause (i)(II). Page 1867 TITLE 15—COMMERCE AND TRADE § 2605 (F) Requirements In conducting a risk evaluation under this subsection, the Administrator shall— (i) integrate and assess available infor- mation on hazards and exposures for the conditions of use of the chemical sub- stance, including information that is rel- evant to specific risks of injury to health or the environment and information on po- tentially exposed or susceptible subpopula- tions identified as relevant by the Admin- istrator; (ii) describe whether aggregate or sen- tinel exposures to a chemical substance under the conditions of use were consid- ered, and the basis for that consideration; (iii) not consider costs or other nonrisk factors; (iv) take into account, where relevant, the likely duration, intensity, frequency, and number of exposures under the condi- tions of use of the chemical substance; and (v) describe the weight of the scientific evidence for the identified hazard and ex- posure. (G) Deadlines The Administrator— (i) 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 (ii) may extend the deadline for a risk evaluation for not more than 6 months. (H) Notice and comment The Administrator shall provide no less than 30 days public notice and an oppor- tunity for comment on a draft risk evalua- tion prior to publishing a final risk evalua- tion. (c) Promulgation of subsection (a) rules (1) Deadlines 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 Ad- ministrator— (A) 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 re- garding the chemical substance is published; (B) shall publish in the Federal Register a final rule not later than 2 years after the date on which the final risk evaluation re- garding the chemical substance is published; and (C) 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 sub- section (b)(4)(G)(ii) does not exceed 2 years, and subject to the limitation that the Ad- ministrator may not extend a deadline for the publication of a proposed or final rule re- garding a chemical substance drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments or a chemical sub- stance that, with respect to persistence and bioaccumulation, scores high for 1 and ei- ther high or moderate for the other, pursu- ant to the TSCA Work Plan Chemicals Methods Document published by the Admin- istrator in February 2012 (or a successor scoring system), without adequate public justification that demonstrates, following a review of the information reasonably avail- able to the Administrator, that the Adminis- trator cannot complete the proposed or final rule without additional information regard- ing the chemical substance. (2) Requirements for rule (A) Statement of effects In proposing and promulgating a rule under subsection (a) with respect to a chem- ical substance or mixture, the Adminis- trator shall consider and publish a state- ment based on reasonably available informa- tion with respect to— (i) the effects of the chemical substance or mixture on health and the magnitude of the exposure of human beings to the chem- ical substance or mixture; (ii) the effects of the chemical substance or mixture on the environment and the magnitude of the exposure of the environ- ment to such substance or mixture; (iii) the benefits of the chemical sub- stance or mixture for various uses; and (iv) the reasonably ascertainable eco- nomic consequences of the rule, including consideration of— (I) the likely effect of the rule on the national economy, small business, tech- nological innovation, the environment, and public health; (II) the costs and benefits of the pro- posed and final regulatory action and of the 1 or more primary alternative regu- latory actions considered by the Admin- istrator; and (III) the cost effectiveness of the pro- posed regulatory action and of the 1 or more primary alternative regulatory ac- tions considered by the Administrator. (B) Selecting requirements In selecting among prohibitions and other restrictions, the Administrator shall factor in, to the extent practicable, the consider- ations under subparagraph (A) in accordance with subsection (a). (C) Consideration of alternatives Based on the information published under subparagraph (A), in deciding whether to prohibit or restrict in a manner that sub- stantially 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 con- sider, to the extent practicable, whether technically and economically feasible alter- natives that benefit health or the environ- ment, 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. Page 1868 TITLE 15—COMMERCE AND TRADE § 2605 (D) Replacement parts (i) In general The Administrator shall exempt replace- ment parts for complex durable goods and complex consumer goods that are designed prior to the date of publication in the Fed- eral Register of the rule under subsection (a), unless the Administrator finds that such replacement parts contribute signifi- cantly to the risk, identified in a risk eval- uation conducted under subsection (b)(4)(A), to the general population or to an identified potentially exposed or sus- ceptible subpopulation. (ii) Definitions In this subparagraph— (I) the term ‘‘complex consumer goods’’ means electronic or mechanical devices composed of multiple manufac- tured components, with an intended use- ful life of 3 or more years, where the product is typically not consumed, de- stroyed, or discarded after a single use, and the components of which would be impracticable to redesign or replace; and (II) 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. (E) Articles 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 sub- stance or mixture from the article or cat- egory 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). (3) Procedures When prescribing a rule under subsection (a) the Administrator shall proceed in accordance with section 553 of title 5 (without regard to any reference in such section to sections 556 and 557 of such title), and shall also— (A) publish a notice of proposed rule- making stating with particularity the rea- son for the proposed rule; (B) allow interested persons to submit written data, views, and arguments, and make all such submissions publicly avail- able; (C) promulgate a final rule based on the matter in the rulemaking record; and (D) make and publish with the rule the de- termination described in subsection (a). (d) Effective date (1) IN GENERAL.—In any rule under subsection (a), the Administrator shall— (A) specify the date on which it shall take effect, which date shall be as soon as prac- ticable; (B) 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 prac- ticable, 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); (C) 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); (D) specify mandatory compliance dates for full implementation of ban or phase-out re- quirements under a rule under subsection (a), which shall be as soon as practicable; and (E) provide for a reasonable transition pe- riod. (2) VARIABILITY.—As determined by the Ad- ministrator, the compliance dates established under paragraph (1) may vary for different af- fected persons. (3)(A) The Administrator may declare a pro- posed rule under subsection (a) to be effective, and compliance with the proposed requirements to be mandatory, upon publication in the Fed- eral Register of the proposed rule and until the compliance dates applicable to such require- ments in a final rule promulgated under section 2605(a) of this title or until the Administrator revokes such proposed rule, in accordance with subparagraph (B), if— (i) the Administrator determines that— (I) the manufacture, processing, distribu- tion in commerce, use, or disposal of the chemical substance or mixture subject to such proposed rule or any combination of such activities is likely to result in an un- reasonable risk of serious or widespread in- jury to health or the environment before such effective date without consideration of costs or other non-risk factors; and (II) making such proposed rule so effective is necessary to protect the public interest; and (ii) 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 clause (i)(I), a court has in an action under section 2606 of this title granted relief with respect to such risk associ- ated with such substance or mixture. Such a proposed rule which is made so effective shall not, for purposes of judicial review, be con- sidered final agency action. (B) If the Administrator makes a proposed rule effective upon its publication in the Federal Register, the Administrator shall, as expedi- tiously as possible, give interested persons prompt notice of such action in accordance with subsection (c), and either promulgate such rule (as proposed or with modifications) or revoke it. (e) Polychlorinated biphenyls (1) Within six months after January 1, 1977, the Administrator shall promulgate rules to— (A) prescribe methods for the disposal of pol- ychlorinated biphenyls, and Page 1869 TITLE 15—COMMERCE AND TRADE § 2605 (B) require polychlorinated biphenyls to be marked with clear and adequate warnings, and instructions with respect to their processing, distribution in commerce, use, or disposal or with respect to any combination of such ac- tivities. Requirements prescribed by rules under this paragraph shall be consistent with the require- ments of paragraphs (2) and (3). (2)(A) Except as provided under subparagraph (B), effective one year after January 1, 1977, no person may manufacture, process, or distribute in commerce or use any polychlorinated biphenyl in any manner other than in a totally enclosed manner. (B) The Administrator may by rule authorize the manufacture, processing, distribution in commerce or use (or any combination of such activities) of any polychlorinated biphenyl in a manner other than in a totally enclosed manner if the Administrator finds that such manufac- ture, processing, distribution in commerce, or use (or combination of such activities) will not present an unreasonable risk of injury to health or the environment. (C) For the purposes of this paragraph, the term ‘‘totally enclosed manner’’ means any manner which will ensure that any exposure of human beings or the environment to a poly- chlorinated biphenyl will be insignificant as de- termined by the Administrator by rule. (3)(A) Except as provided in subparagraphs (B) and (C)— (i) no person may manufacture any poly- chlorinated biphenyl after two years after January 1, 1977, and (ii) no person may process or distribute in commerce any polychlorinated biphenyl after two and one-half years after such date. (B) Any person may petition the Adminis- trator for an exemption from the requirements of subparagraph (A), and the Administrator may grant by rule such an exemption if the Adminis- trator finds that— (i) an unreasonable risk of injury to health or environment would not result, and (ii) good faith efforts have been made to de- velop a chemical substance which does not present an unreasonable risk of injury to health or the environment and which may be substituted for such polychlorinated biphenyl. An exemption granted under this subparagraph shall be subject to such terms and conditions as the Administrator may prescribe and shall be in effect for such period (but not more than one year from the date it is granted) as the Adminis- trator may prescribe. (C) Subparagraph (A) shall not apply to the distribution in commerce of any polychlorinated biphenyl if such polychlorinated biphenyl was sold for purposes other than resale before two and one half years after October 11, 1976. (4) Any rule under paragraph (1), (2)(B), or (3)(B) shall be promulgated in accordance with paragraph (3) of subsection (c). (5) This subsection does not limit the author- ity of the Administrator, under any other provi- sion of this chapter or any other Federal law, to take action respecting any polychlorinated biphenyl. (f) Mercury (1) Prohibition on sale, distribution, or trans- fer of elemental mercury by Federal agen- cies Except as provided in paragraph (2), effective beginning on October 14, 2008, no Federal agen- cy shall convey, sell, or distribute to any other Federal agency, any State or local gov- ernment agency, or any private individual or entity any elemental mercury under the con- trol or jurisdiction of the Federal agency. (2) Exceptions Paragraph (1) shall not apply to— (A) a transfer between Federal agencies of elemental mercury for the sole purpose of fa- cilitating storage of mercury to carry out this chapter; or (B) a conveyance, sale, distribution, or transfer of coal. (3) Leases of Federal coal Nothing in this subsection prohibits the leasing of coal. (g) Exemptions (1) Criteria for exemption The Administrator may, as part of a rule promulgated under subsection (a), or in a sepa- rate rule, grant an exemption from a require- ment of a subsection (a) rule for a specific con- dition of use of a chemical substance or mix- ture, if the Administrator finds that— (A) the specific condition of use is a crit- ical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration haz- ard and exposure; (B) compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the na- tional economy, national security, or crit- ical infrastructure; or (C) the specific condition of use of the chemical substance or mixture, as compared to reasonably available alternatives, pro- vides a substantial benefit to health, the en- vironment, or public safety. (2) Exemption analysis and statement In proposing an exemption under this sub- section, 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. (3) Period of exemption 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 Adminis- trator determines, on the basis of reasonably available information and after adequate pub- lic justification, the exemption warrants ex- tension or modification or is no longer nec- essary. (4) Conditions As part of a rule promulgated under this subsection, the Administrator shall include Page 1870 TITLE 15—COMMERCE AND TRADE § 2605 conditions, including reasonable record- keeping, monitoring, and reporting require- ments, to the extent that the Administrator determines the conditions are necessary to protect health and the environment while achieving the purposes of the exemption. (h) Chemicals that are persistent, bioaccumula- tive, and toxic (1) Expedited action Not later than 3 years after June 22, 2016, the Administrator shall propose rules under sub- section (a) with respect to chemical sub- stances identified in the 2014 update of the TSCA Work Plan for Chemical Assessments— (A) that the Administrator has a reason- able basis to conclude are toxic and that with respect to persistence and bioaccumu- lation score high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Docu- ment published by the Administrator in Feb- ruary 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 Formula- tion, initiated a review under section 5, or entered into a consent agreement under sec- tion 2603 of this title, prior to June 22, 2016; and (B) exposure to which under the conditions of use is likely to the general population or to a potentially exposed or susceptible sub- population identified by the Administrator, or the environment, on the basis of an expo- sure and use assessment conducted by the Administrator. (2) No risk evaluation required The Administrator shall not be required to conduct risk evaluations on chemical sub- stances that are subject to paragraph (1). (3) Final rule Not later than 18 months after proposing a rule pursuant to paragraph (1), the Adminis- trator shall promulgate a final rule under sub- section (a). (4) Selecting restrictions In selecting among prohibitions and other restrictions promulgated in a rule under sub- section (a) pursuant to paragraph (1), the Ad- ministrator shall address the risks of injury to health or the environment that the Adminis- trator determines are presented by the chem- ical substance and shall reduce exposure to the substance to the extent practicable. (5) Relationship to subsection (b) If, at any time prior to the date that is 90 days after June 22, 2016, the Administrator makes a designation under subsection (b)(1)(B)(i), or receives a request under sub- section (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. (i) Final agency action Under this section and subject to section 2617 of this title— (1) a determination by the Administrator under subsection (b)(4)(A) that a chemical sub- stance 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 (2) 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 unrea- sonable risk of injury to health or the environ- ment, shall be considered to be a final agency action, effective beginning on the date of pro- mulgation of the final rule. (j) Definition For the purposes of this chapter, the term ‘‘re- quirement’’ as used in this section shall not dis- place statutory or common law. (Pub. L. 94–469, title I, § 6, Oct. 11, 1976, 90 Stat. 2020; renumbered title I, Pub. L. 99–519, § 3(c)(1), Oct. 22, 1986, 100 Stat. 2989; amended Pub. L. 109–364, div. A, title III, § 317(a), Oct. 17, 2006, 120 Stat. 2142; Pub. L. 110–414, § 3, Oct. 14, 2008, 122 Stat. 4342; Pub. L. 114–182, title I, § 6, June 22, 2016, 130 Stat. 460.) Editorial Notes AMENDMENTS 2016—Pub. L. 114–182, § 6(1), substituted ‘‘Prioritization, risk evaluation, and regulation of chemical substances and mixtures’’ for ‘‘Regulation of hazardous chemical substances and mixtures’’ in sec- tion catchline. Subsec. (a). Pub. L. 114–182, § 6(2)(A)–(D), in introduc- tory provisions, substituted ‘‘determines in accordance with subsection (b)(4)(A)’’ for ‘‘finds that there is a rea- sonable basis to conclude’’ and ‘‘so that the chemical substance or mixture no longer presents such risk’’ for ‘‘to protect adequately against such risk using the least burdensome requirements’’, struck out ‘‘or will present’’ after ‘‘presents’’, and inserted ‘‘and subject to section 2617 of this title, and in accordance with sub- section (c)(2),’’ after ‘‘shall by rule’’. Subsec. (a)(1)(A), (2)(A). Pub. L. 114–182, § 6(2)(E), in- serted ‘‘or otherwise restricting’’ after ‘‘prohibiting’’. Subsec. (a)(3). Pub. L. 114–182, § 6(2)(F), inserted ‘‘min- imum’’ before ‘‘warnings’’ in two places. Subsec. (a)(4). Pub. L. 114–182, § 6(2)(G), substituted ‘‘or monitor or conduct tests’’ for ‘‘and monitor or con- duct tests’’. Subsec. (a)(7). Pub. L. 114–182, § 6(2)(H), substituted ‘‘such determination’’ for ‘‘such unreasonable risk of injury’’ in subpar. (A) and for ‘‘such risk of injury’’ in subpar. (B). Subsec. (b). Pub. L. 114–182, § 6(3), amended subsec. (b) generally. Prior to amendment, subsec. (b) related to quality control procedures in the manufacturing or processing of a chemical substance or mixture to pre- vent unreasonable risk of injury to health or the envi- ronment. Subsec. (c). Pub. L. 114–182, § 6(4), amended subsec. (c) generally. Prior to amendment, subsec. (c) related to promulgation of subsection (a) rules. Subsec. (d)(1), (2). Pub. L. 114–182, § 6(5)(B), added pars. (1) and (2) and struck out former par. (1) which read as follows: ‘‘The Administrator shall specify in any rule under subsection (a) the date on which it shall take ef- fect, which date shall be as soon as feasible.’’ Former par. (2) redesignated (3). Page 1871 TITLE 15—COMMERCE AND TRADE § 2606 Subsec. (d)(3). Pub. L. 114–182, § 6(5)(A), redesignated par. (2) as (3). Subsec. (d)(3)(A). Pub. L. 114–182, § 6(5)(C)(i)(I), in in- troductory provisions, substituted ‘‘, 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 re- quirements in a final rule promulgated under section 2605(a) of this title or until the Administrator revokes such proposed rule, in accordance with subparagraph (B), if’’ for ‘‘upon its publication in the Federal Reg- ister and until the effective date of final action taken, in accordance with subparagraph (B), respecting such rule if’’. Subsec. (d)(3)(A)(i)(I). Pub. L. 114–182, § 6(5)(C)(i)(II), inserted ‘‘without consideration of costs or other non- risk factors’’ after ‘‘effective date’’. Subsec. (d)(3)(B). Pub. L. 114–182, § 6(5)(C)(ii), sub- stituted ‘‘in accordance with subsection (c), and either promulgate such rule (as proposed or with modifica- tions) or revoke it.’’ for ‘‘, provide reasonable oppor- tunity, in accordance with paragraphs (2) and (3) of sub- section (c), for a hearing on such rule, and either pro- mulgate such rule (as proposed or with modifications) or revoke it; and if such a hearing is requested, the Ad- ministrator shall commence the hearing within five days from the date such request is made unless the Ad- ministrator and the person making the request agree upon a later date for the hearing to begin, and after the hearing is concluded the Administrator shall, within ten days of the conclusion of the hearing, either pro- mulgate such rule (as proposed or with modifications) or revoke it.’’ Subsec. (e)(4). Pub. L. 114–182, § 6(6), substituted ‘‘paragraph (3)’’ for ‘‘paragraphs (2), (3), and (4)’’. Subsecs. (g) to (j). Pub. L. 114–182, § 6(7), added sub- secs. (g) to (j). 2008—Subsec. (f). Pub. L. 110–414 added subsec. (f). 2006—Subsec. (e)(3)(A). Pub. L. 109–364, § 317(a)(1), (b), temporarily substituted ‘‘subparagraphs (B), (C), and (D)’’ for ‘‘subparagraphs (B) and (C)’’ in introductory provisions. See Termination Date of 2006 Amendment note below. Subsec. (e)(3)(B). Pub. L. 109–364, § 317(a)(2), (b), tem- porarily substituted ‘‘but not more than 1 year from the date it is granted, except as provided in subpara- graph (D)’’ for ‘‘but not more than one year from the date it is granted’’ in concluding provisions. See Termi- nation Date of 2006 Amendment note below. Subsec. (e)(3)(D). Pub. L. 109–364, § 317(a)(3), (b), tem- porarily added subpar. (D) which read as follows: ‘‘The Administrator may extend an exemption granted pur- suant to subparagraph (B) that has not yet expired for a period not to exceed 60 days for the purpose of au- thorizing the Secretary of Defense and the Secretaries of the military departments to provide for the trans- portation into the customs territory of the United States of polychlorinated biphenyls generated by or under the control of the Department of Defense for pur- poses of their disposal, treatment, or storage in the customs territory of the United States if those poly- chlorinated biphenyls are already in transit from their storage locations but the Administrator determines, in the sole discretion of the Administrator, they would not otherwise arrive in the customs territory of the United States within the period of the original exemp- tion. The Administrator shall promptly publish notice of such extension in the Federal Register.’’ See Termi- nation Date of 2006 Amendment note below. Statutory Notes and Related Subsidiaries TERMINATION DATE OF 2006 AMENDMENT Pub. L. 109–364, div. A, title III, § 317(b), Oct. 17, 2006, 120 Stat. 2142, provided that: ‘‘The amendments made by subsection (a) [amending this section] shall cease to have effect on September 30, 2012. The termination of the authority to grant exemptions pursuant to such amendments shall not effect the validity of any exemp- tion granted prior to such date.’’ EFFECTIVE DATE Section effective Jan. 1, 1977, see section 31 of Pub. L. 94–469, set out as a note under section 2601 of this title. § 2606. Imminent hazards (a) Actions authorized and required (1) The Administrator may commence a civil action in an appropriate district court of the United States— (A) for seizure of an imminently hazardous chemical substance or mixture or any article containing such a substance or mixture, (B) for relief (as authorized by subsection (b)) against any person who manufactures, processes, distributes in commerce, or uses, or disposes of, an imminently hazardous chem- ical substance or mixture or any article con- taining such a substance or mixture, or (C) for both such seizure and relief. A civil action may be commenced under this paragraph notwithstanding the existence of a determination under section 2604 or 2605 of this title, a rule under section 2603, 2604, or 2605 of this title or subchapter IV, an order under sec- tion 2603, 2604, or 2605 of this title or subchapter IV, or a consent agreement under section 2603 of this title, and notwithstanding the pendency of any administrative or judicial proceeding under any provision of this chapter. (2) If the Administrator has not made a rule under section 2605(a) of this title immediately effective (as authorized by section 2605(d)(3)(A)(i) of this title) with respect to an imminently hazardous chemical substance or mixture, the Administrator shall commence in a district court of the United States with respect to such substance or mixture or article con- taining such substance or mixture a civil action described in subparagraph (A), (B), or (C) of paragraph (1). (b) Relief authorized (1) The district court of the United States in which an action under subsection (a) is brought shall have jurisdiction to grant such temporary or permanent relief as may be necessary to pro- tect health or the environment from the unrea- sonable risk (as identified by the Administrator without consideration of costs or other nonrisk factors) associated with the chemical substance, mixture, or article involved in such action. (2) In the case of an action under subsection (a) brought against a person who manufactures, processes, or distributes in commerce a chem- ical substance or mixture or an article con- taining a chemical substance or mixture, the re- lief authorized by paragraph (1) may include the issuance of a mandatory order requiring (A) in the case of purchasers of such substance, mix- ture, or article known to the defendant, notifi- cation to such purchasers of the risk associated with it; (B) public notice of such risk; (C) recall; (D) the replacement or repurchase of such sub- stance, mixture, or article; or (E) any combina- tion of the actions described in the preceding clauses. (3) In the case of an action under subsection (a) against a chemical substance, mixture, or ar- ticle, such substance, mixture, or article may be proceeded against by process of libel for its sei-