---
kind: "section"
citation: "15 U.S.C. § 2605"
title: "15"
title_heading: "Commerce and Trade"
number: "2605"
heading: "Prioritization, risk evaluation, and regulation of chemical substances and mixtures"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/15/2605"
units:
  - "Chapter 53 — Toxic Substances Control"
  - "Subchapter I — Control of Toxic Substances"
---

# §2605. Prioritization, risk evaluation, and regulation of chemical substances and mixtures

- (a) **Scope of regulation—** If the [Administrator](/usc/15/2602.md?p=1) determines in accordance with [subsection (b)(4)(A)](#b-4-A) that the [manufacture](/usc/15/2602.md?p=9), processing, [distribution in commerce](/usc/15/2602.md?p=5), use, or disposal of a [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10), or that any combination of such activities, presents an unreasonable risk of injury to health or the [environment](/usc/15/2602.md?p=6), the [Administrator](/usc/15/2602.md?p=1) shall by rule and subject to [section 2617 of this title](/usc/15/2617.md), and in accordance with [subsection (c)(2)](#c-2), apply one or more of the following requirements to such substance or [mixture](/usc/15/2602.md?p=10) to the extent necessary so that the [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10) no longer presents such risk:
  - (1) A requirement (A) prohibiting or otherwise restricting the manufacturing, processing, or [distribution in commerce](/usc/15/2602.md?p=5) of such substance or [mixture](/usc/15/2602.md?p=10), or (B) limiting the amount of such substance or [mixture](/usc/15/2602.md?p=10) which may be manufactured, processed, or distributed in [commerce](/usc/15/2602.md?p=3).
  - (2) A requirement—
    - (A) prohibiting or otherwise restricting the [manufacture](/usc/15/2602.md?p=9), processing, or [distribution in commerce](/usc/15/2602.md?p=5) of such substance or [mixture](/usc/15/2602.md?p=10) for (i) a particular use or (ii) a particular use in a concentration in excess of a level specified by the [Administrator](/usc/15/2602.md?p=1) in the rule imposing the requirement, or
    - (B) limiting the amount of such substance or [mixture](/usc/15/2602.md?p=10) which may be manufactured, processed, or distributed in [commerce](/usc/15/2602.md?p=3) for (i) a particular use or (ii) a particular use in a concentration in excess of a level specified by the [Administrator](/usc/15/2602.md?p=1) in the rule imposing the requirement.
  - (3) A requirement that such substance or [mixture](/usc/15/2602.md?p=10) or any article containing such substance or [mixture](/usc/15/2602.md?p=10) be marked with or accompanied by clear and adequate minimum warnings and instructions with respect to its use, [distribution in commerce](/usc/15/2602.md?p=5), or disposal or with respect to any combination of such activities. The form and content of such minimum warnings and instructions shall be prescribed by the [Administrator](/usc/15/2602.md?p=1).
  - (4) A requirement that manufacturers and [processors](/usc/15/2602.md?p=14) of such substance or [mixture](/usc/15/2602.md?p=10) make and retain records of the [processes](/usc/15/2602.md?p=13) used to [manufacture](/usc/15/2602.md?p=9) or [process](/usc/15/2602.md?p=13) such substance or [mixture](/usc/15/2602.md?p=10) 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 commercial use of such substance or [mixture](/usc/15/2602.md?p=10).
  - (6)
    - (A) A requirement prohibiting or otherwise regulating any manner or method of disposal of such substance or [mixture](/usc/15/2602.md?p=10), or of any article containing such substance or [mixture](/usc/15/2602.md?p=10), by its manufacturer or [processor](/usc/15/2602.md?p=14) or by any other [person](/usc/15/7a.md?p=6) who uses, or disposes of, it for commercial purposes.
    - (B) A requirement under [subparagraph (A)](#a-6-A) may not require any [person](/usc/15/7a.md?p=6) to take any action which would be in violation of any law or requirement of, or in effect for, a [State](/usc/15/2602.md?p=16) or political subdivision, and shall require each [person](/usc/15/7a.md?p=6) subject to it to notify each [State](/usc/15/2602.md?p=16) and political subdivision in which a required disposal may occur of such disposal.
  - (7) A requirement directing manufacturers or [processors](/usc/15/2602.md?p=14) of such substance or [mixture](/usc/15/2602.md?p=10) (A) to give notice of such determination to distributors in [commerce](/usc/15/2602.md?p=3) of such substance or [mixture](/usc/15/2602.md?p=10) and, to the extent reasonably ascertainable, to other [persons](/usc/15/7a.md?p=6) in possession of such substance or [mixture](/usc/15/2602.md?p=10) or exposed to such substance or [mixture](/usc/15/2602.md?p=10), (B) to give public notice of such determination, and (C) to replace or repurchase such substance or [mixture](/usc/15/2602.md?p=10) as elected by the [person](/usc/15/7a.md?p=6) to which the requirement is directed.

  Any requirement (or combination of requirements) 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](/usc/15/2602.md?p=1) shall establish, by rule, a risk-based screening [process](/usc/15/2602.md?p=13), including criteria for designating [chemical substances](/usc/15/2602.md?p=2-A) as high-priority substances for risk evaluations or low-priority substances for which risk evaluations are not warranted at the time. The [process](/usc/15/2602.md?p=13) to designate the priority of [chemical substances](/usc/15/2602.md?p=2-A) shall include a consideration of the hazard and exposure potential of a [chemical substance](/usc/15/2602.md?p=2-A) or a category of [chemical substances](/usc/15/2602.md?p=2-A) (including consideration of persistence and bioaccumulation, [potentially exposed or susceptible subpopulations](/usc/15/2602.md?p=12) and storage near significant sources of drinking water), the [conditions of use](/usc/15/2602.md?p=4) or significant changes in the [conditions of use](/usc/15/2602.md?p=4) of the [chemical substance](/usc/15/2602.md?p=2-A), and the volume or significant changes in the volume of the [chemical substance](/usc/15/2602.md?p=2-A) manufactured or processed.
    - (B) **Identification of priorities for risk evaluation—**
      - (i) **High-priority substances—** The [Administrator](/usc/15/2602.md?p=1) shall designate as a high-priority substance a [chemical substance](/usc/15/2602.md?p=2-A) that the [Administrator](/usc/15/2602.md?p=1) concludes, without consideration of costs or other nonrisk factors, may present an unreasonable risk of injury to health or the [environment](/usc/15/2602.md?p=6) because of a potential hazard and a potential route of exposure under the [conditions of use](/usc/15/2602.md?p=4), including an unreasonable risk to a [potentially exposed or susceptible subpopulation](/usc/15/2602.md?p=12) identified as relevant by the [Administrator](/usc/15/2602.md?p=1).
      - (ii) **Low-priority substances—** The [Administrator](/usc/15/2602.md?p=1) shall designate a [chemical substance](/usc/15/2602.md?p=2-A) as a low-priority substance if the [Administrator](/usc/15/2602.md?p=1) concludes, based on information sufficient to establish, without consideration of costs or other nonrisk factors, that such substance does not meet the standard identified in [clause (i)](#b-1-B-i) for designating a [chemical substance](/usc/15/2602.md?p=2-A) a high-priority substance.
    - (C) **Information request and review and proposed and final prioritization designation—** The rulemaking required in [subparagraph (A)](#b-1-A) shall ensure that the time required to make a priority designation of a [chemical substance](/usc/15/2602.md?p=2-A) be no shorter than nine months and no longer than 1 year, and that the [process](/usc/15/2602.md?p=13) for such designations includes—
      - (i) a requirement that the [Administrator](/usc/15/2602.md?p=1) request interested [persons](/usc/15/7a.md?p=6) to submit relevant information on a [chemical substance](/usc/15/2602.md?p=2-A) that the [Administrator](/usc/15/2602.md?p=1) has initiated the prioritization [process](/usc/15/2602.md?p=13) on, before proposing a priority designation for the [chemical substance](/usc/15/2602.md?p=2-A), and provide 90 days for such information to be provided;
      - (ii) a requirement that the [Administrator](/usc/15/2602.md?p=1) publish each proposed designation of a [chemical substance](/usc/15/2602.md?p=2-A) as a high- or low-priority substance, along with an identification of the information, analysis, and basis used to make the proposed designations, and provide 90 days for public comment on each such proposed designation; and
      - (iii) a [process](/usc/15/2602.md?p=13) by which the [Administrator](/usc/15/2602.md?p=1) may extend the deadline in [clause (i)](#b-1-C-i) for up to three months in order to receive or evaluate information required to be submitted in accordance with [section 2603(a)(2)(B) of this title](/usc/15/2603.md?p=a-2-B), subject to the limitation that if the information available to the [Administrator](/usc/15/2602.md?p=1) at the end of such an extension remains insufficient to enable the designation of the [chemical substance](/usc/15/2602.md?p=2-A) as a low-priority substance, the [Administrator](/usc/15/2602.md?p=1) shall designate the [chemical substance](/usc/15/2602.md?p=2-A) as a high-priority substance.
  - (2) **Initial risk evaluations and subsequent designations of high- and low-priority substances—**
    - (A) **Initial risk evaluations—** Not later than 180 days after June 22, 2016, the [Administrator](/usc/15/2602.md?p=1) shall ensure that risk evaluations are being conducted on 10 [chemical substances](/usc/15/2602.md?p=2-A) drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments and shall publish the list of such [chemical substances](/usc/15/2602.md?p=2-A) during the 180 day period.
    - (B) **Additional risk evaluations—** Not later than three and one half years after June 22, 2016, the [Administrator](/usc/15/2602.md?p=1) shall ensure that risk evaluations are being conducted on at least 20 high-priority substances and that at least 20 [chemical substances](/usc/15/2602.md?p=2-A) have been designated as low-priority substances, subject to the limitation that at least 50 percent of all [chemical substances](/usc/15/2602.md?p=2-A) on which risk evaluations are being conducted by the [Administrator](/usc/15/2602.md?p=1) are drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments.
    - (C) **Continuing designations and risk evaluations—** The [Administrator](/usc/15/2602.md?p=1) shall continue to designate priority substances and conduct risk evaluations in accordance with this subsection at a pace consistent with the ability of the [Administrator](/usc/15/2602.md?p=1) to complete risk evaluations in accordance with the deadlines under [paragraph (4)(G)](#b-4-G).
    - (D) **Preference—** In designating high-priority substances, the [Administrator](/usc/15/2602.md?p=1) shall give preference to—
      - (i) [chemical substances](/usc/15/2602.md?p=2-A) that are listed in the 2014 update of the TSCA Work Plan for Chemical Assessments as having a Persistence and Bioaccumulation Score of 3; and
      - (ii) [chemical substances](/usc/15/2602.md?p=2-A) 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 evaluation and conducting risk evaluations of metals and metal compounds, the [Administrator](/usc/15/2602.md?p=1) shall use the Framework for Metals Risk Assessment of the Office of the Science Advisor, Risk Assessment Forum, and dated March 2007, or a successor document that addresses metals risk assessment and is peer reviewed by the Science Advisory Board.
  - (3) **Initiation of risk evaluations; designations—**
    - (A) **Risk evaluation initiation—** Upon designating a [chemical substance](/usc/15/2602.md?p=2-A) as a high-priority substance, the [Administrator](/usc/15/2602.md?p=1) shall initiate a risk evaluation on the substance.
    - (B) **Revision—** The [Administrator](/usc/15/2602.md?p=1) may revise the designation of a low-priority substance based on information made available to the [Administrator](/usc/15/2602.md?p=1).
    - (C) **Ongoing designations—** The [Administrator](/usc/15/2602.md?p=1) shall designate at least one high-priority substance upon the completion of each risk evaluation (other than risk evaluations for [chemical substances](/usc/15/2602.md?p=2-A) designated under [paragraph (4)(C)(ii)](#b-4-C-ii)).
  - (4) **Risk evaluation process and deadlines—**
    - (A) **In general—** The [Administrator](/usc/15/2602.md?p=1) shall conduct risk evaluations pursuant to this paragraph to determine whether a [chemical substance](/usc/15/2602.md?p=2-A) presents an unreasonable risk of injury to health or the [environment](/usc/15/2602.md?p=6), without consideration of costs or other nonrisk factors, including an unreasonable risk to a [potentially exposed or susceptible subpopulation](/usc/15/2602.md?p=12) identified as relevant to the risk evaluation by the [Administrator](/usc/15/2602.md?p=1), under the [conditions of use](/usc/15/2602.md?p=4).
    - (B) **Establishment of process—** Not later than 1 year after June 22, 2016, the [Administrator](/usc/15/2602.md?p=1) shall establish, by rule, a [process](/usc/15/2602.md?p=13) to conduct risk evaluations in accordance with [subparagraph (A)](#b-4-A).
    - (C) **Requirement—** The [Administrator](/usc/15/2602.md?p=1) shall conduct and publish risk evaluations, in accordance with the rule promulgated under [subparagraph (B)](#b-4-B), for a [chemical substance](/usc/15/2602.md?p=2-A)—
      - (i) that has been identified under [paragraph (2)(A)](#b-2-A) or designated under [paragraph (1)(B)(i)](#b-1-B-i); and
      - (ii) subject to [subparagraph (E)](#b-4-E), that a manufacturer of the [chemical substance](/usc/15/2602.md?p=2-A) has requested, in a form and manner and using the criteria prescribed by the [Administrator](/usc/15/2602.md?p=1) in the rule promulgated under [subparagraph (B)](#b-4-B), be subjected to a risk evaluation.
    - (D) **Scope—** The [Administrator](/usc/15/2602.md?p=1) shall, not later than 6 months after the initiation of a risk evaluation, publish the scope of the risk evaluation to be conducted, including the hazards, exposures, [conditions of use](/usc/15/2602.md?p=4), and the [potentially exposed or susceptible subpopulations](/usc/15/2602.md?p=12) the [Administrator](/usc/15/2602.md?p=1) expects to consider, and, for each designation of a high-priority substance, ensure not less than 12 months between the initiation of the prioritization [process](/usc/15/2602.md?p=13) for the [chemical substance](/usc/15/2602.md?p=2-A) and the publication of the scope of the risk evaluation for the [chemical substance](/usc/15/2602.md?p=2-A), and for risk evaluations conducted on [chemical substances](/usc/15/2602.md?p=2-A) that have been identified under [paragraph (2)(A)](#b-2-A) or selected under subparagraph (E)(iv)(II) of this paragraph, ensure not less than 3 months before the [Administrator](/usc/15/2602.md?p=1) publishes the scope of the risk evaluation.
    - (E) **Limitation and criteria—**
      - (i) **Percentage requirements—** The [Administrator](/usc/15/2602.md?p=1) shall ensure that, of the number of [chemical substances](/usc/15/2602.md?p=2-A) that undergo a risk evaluation under [clause (i)](#b-4-C-i) of subparagraph (C), the number of [chemical substances](/usc/15/2602.md?p=2-A) undergoing a risk evaluation under [clause (ii)](#b-4-C-ii) of subparagraph (C) is—
        - (I) not less than 25 percent, if sufficient requests are made under [clause (ii)](#b-4-C-ii) of subparagraph (C); and
        - (II) not more than 50 percent.
      - (ii) **Requested risk evaluations—** Requests for risk evaluations under [subparagraph (C)(ii)](#b-4-C-ii) shall be subject to the payment of fees pursuant to [section 2625(b) of this title](/usc/15/2625.md?p=b), and the [Administrator](/usc/15/2602.md?p=1) shall not expedite or otherwise provide special treatment to such risk evaluations.
      - (iii) **Preference—** In deciding whether to grant requests under [subparagraph (C)(ii)](#b-4-C-ii), the [Administrator](/usc/15/2602.md?p=1) shall give preference to requests for risk evaluations on [chemical substances](/usc/15/2602.md?p=2-A) for which the [Administrator](/usc/15/2602.md?p=1) determines that restrictions imposed by 1 or more [States](/usc/15/2602.md?p=16) have the potential to have a significant impact on interstate [commerce](/usc/15/2602.md?p=3) or health or the [environment](/usc/15/2602.md?p=6).
      - (iv) **Exceptions—**
        - (I) [Chemical substances](/usc/15/2602.md?p=2-A) for which requests have been granted under [subparagraph (C)(ii)](#b-4-C-ii) shall not be subject to [section 2617(b) of this title](/usc/15/2617.md?p=b).
        - (II) Requests for risk evaluations on [chemical substances](/usc/15/2602.md?p=2-A) which are made under [subparagraph (C)(ii)](#b-4-C-ii) and that are drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments shall be granted at the discretion of the [Administrator](/usc/15/2602.md?p=1) and not be subject to [clause (i)(II)](#b-4-E-i-II).
    - (F) **Requirements—** In conducting a risk evaluation under this subsection, the [Administrator](/usc/15/2602.md?p=1) shall—
      - (i) integrate and assess available information on hazards and exposures for the [conditions of use](/usc/15/2602.md?p=4) of the [chemical substance](/usc/15/2602.md?p=2-A), including information that is relevant to specific risks of injury to health or the [environment](/usc/15/2602.md?p=6) and information on [potentially exposed or susceptible subpopulations](/usc/15/2602.md?p=12) identified as relevant by the [Administrator](/usc/15/2602.md?p=1);
      - (ii) describe whether aggregate or sentinel exposures to a [chemical substance](/usc/15/2602.md?p=2-A) under the [conditions of use](/usc/15/2602.md?p=4) were considered, 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 [conditions of use](/usc/15/2602.md?p=4) of the [chemical substance](/usc/15/2602.md?p=2-A); and
      - (v) describe the weight of the scientific evidence for the identified hazard and exposure.
    - (G) **Deadlines—** The [Administrator](/usc/15/2602.md?p=1)—
      - (i) shall complete a risk evaluation for a [chemical substance](/usc/15/2602.md?p=2-A) as soon as practicable, but not later than 3 years after the date on which the [Administrator](/usc/15/2602.md?p=1) initiates the risk evaluation under [subparagraph (C)](#b-4-C); and
      - (ii) may extend the deadline for a risk evaluation for not more than 6 months.
    - (H) **Notice and comment—** The [Administrator](/usc/15/2602.md?p=1) shall provide no less than 30 days public notice and an opportunity for comment on a draft risk evaluation prior to publishing a final risk evaluation.
- (c) **Promulgation of subsection (a) rules—**
  - (1) **Deadlines—** If the [Administrator](/usc/15/2602.md?p=1) determines that a [chemical substance](/usc/15/2602.md?p=2-A) presents an unreasonable risk of injury to health or the [environment](/usc/15/2602.md?p=6) in accordance with [subsection (b)(4)(A)](#b-4-A), the [Administrator](/usc/15/2602.md?p=1)—
    - (A) shall propose in the Federal Register a rule under [subsection (a)](#a) for the [chemical substance](/usc/15/2602.md?p=2-A) not later than 1 year after the date on which the final risk evaluation regarding the [chemical substance](/usc/15/2602.md?p=2-A) 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 regarding the [chemical substance](/usc/15/2602.md?p=2-A) 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 [subsection (b)(4)(G)(ii)](#b-4-G-ii) does not exceed 2 years, and subject to the limitation that the [Administrator](/usc/15/2602.md?p=1) may not extend a deadline for the publication of a proposed or final rule regarding a [chemical substance](/usc/15/2602.md?p=2-A) drawn from the 2014 update of the TSCA Work Plan for Chemical Assessments or a [chemical substance](/usc/15/2602.md?p=2-A) that, with respect to persistence and bioaccumulation, scores high for 1 and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the [Administrator](/usc/15/2602.md?p=1) in February 2012 (or a successor scoring system), without adequate public justification that demonstrates, following a review of the information reasonably available to the [Administrator](/usc/15/2602.md?p=1), that the [Administrator](/usc/15/2602.md?p=1) cannot complete the proposed or final rule without additional information regarding the [chemical substance](/usc/15/2602.md?p=2-A).
  - (2) **Requirements for rule—**
    - (A) **Statement of effects—** In proposing and promulgating a rule under [subsection (a)](#a) with respect to a [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10), the [Administrator](/usc/15/2602.md?p=1) shall consider and publish a statement based on reasonably available information with respect to—
      - (i) the effects of the [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10) on health and the magnitude of the exposure of human beings to the [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10);
      - (ii) the effects of the [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10) on the [environment](/usc/15/2602.md?p=6) and the magnitude of the exposure of the [environment](/usc/15/2602.md?p=6) to such substance or [mixture](/usc/15/2602.md?p=10);
      - (iii) the benefits of the [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10) for various uses; and
      - (iv) the reasonably ascertainable economic consequences of the rule, including consideration of—
        - (I) the likely effect of the rule on the national economy, small business, technological innovation, the [environment](/usc/15/2602.md?p=6), and public health;
        - (II) the costs and benefits of the proposed and final regulatory action and of the 1 or more primary alternative regulatory actions considered by the [Administrator](/usc/15/2602.md?p=1); and
        - (III) the cost effectiveness of the proposed regulatory action and of the 1 or more primary alternative regulatory actions considered by the [Administrator](/usc/15/2602.md?p=1).
    - (B) **Selecting requirements—** In selecting among prohibitions and other restrictions, the [Administrator](/usc/15/2602.md?p=1) shall factor in, to the extent practicable, the considerations under [subparagraph (A)](#c-2-A) in accordance with [subsection (a)](#a).
    - (C) **Consideration of alternatives—** Based on the information published under [subparagraph (A)](#c-2-A), in deciding whether to prohibit or restrict in a manner that substantially prevents a specific condition of use of a [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10), and in setting an appropriate transition period for such action, the [Administrator](/usc/15/2602.md?p=1) shall consider, to the extent practicable, whether technically and economically feasible alternatives that benefit health or the [environment](/usc/15/2602.md?p=6), 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.
    - (D) **Replacement parts—**
      - (i) **In general—** The [Administrator](/usc/15/2602.md?p=1) shall exempt replacement parts for complex durable goods and complex consumer goods that are designed prior to the date of publication in the Federal Register of the rule under [subsection (a)](#a), unless the [Administrator](/usc/15/2602.md?p=1) finds that such replacement parts contribute significantly to the risk, identified in a risk evaluation conducted under [subsection (b)(4)(A)](#b-4-A), to the general population or to an identified [potentially exposed or susceptible subpopulation](/usc/15/2602.md?p=12).
      - (ii) **Definitions—** In this subparagraph—
        - (I) the term “complex consumer goods” means electronic or mechanical [devices](/usc/15/55.md?p=d) composed of multiple manufactured components, with an intended useful life of 3 or more years, where the product is typically not consumed, destroyed, or discarded after a single use, and the components of which would be impracticable to redesign or replace; and
        - (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](/usc/15/2602.md?p=1) shall apply such prohibitions or other restrictions to an article or category of articles containing the [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10) only to the extent necessary to address the identified risks from exposure to the [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10) from the article or category of articles so that the substance or [mixture](/usc/15/2602.md?p=10) does not present an unreasonable risk of injury to health or the [environment](/usc/15/2602.md?p=6) identified in the risk evaluation conducted in accordance with [subsection (b)(4)(A)](#b-4-A).
  - (3) **Procedures—** When prescribing a rule under [subsection (a)](#a) the [Administrator](/usc/15/2602.md?p=1) shall proceed in accordance with [section 553 of title 5](/usc/5/553.md) (without regard to any reference in such section to sections [556](/usc/5/556.md) and [557](/usc/5/557.md) of such title), and shall also—
    - (A) publish a notice of proposed rulemaking stating with particularity the reason for the proposed rule;
    - (B) allow interested [persons](/usc/15/7a.md?p=6) to submit written data, views, and arguments, and make all such submissions publicly available;
    - (C) promulgate a final rule based on the matter in the rulemaking record; and
    - (D) make and publish with the rule the determination described in [subsection (a)](#a).
- (d) **Effective date—**
  - (1) **In general.—** In any rule under [subsection (a)](#a), the [Administrator](/usc/15/2602.md?p=1) shall—
    - (A) specify the date on which it shall take effect, which date shall be as soon as practicable;
    - (B) except as provided in subparagraphs [(C)](#d-1-C) and [(D)](#d-1-D), specify mandatory compliance dates for all of the requirements under a rule under [subsection (a)](#a), which shall be as soon as practicable, but not later than 5 years after the date of promulgation of the rule, except in a case of a use exempted under [subsection (g)](#g);
    - (C) specify mandatory compliance dates for the start of ban or phase-out requirements under a rule under [subsection (a)](#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)](#g);
    - (D) specify mandatory compliance dates for full implementation of ban or phase-out requirements under a rule under [subsection (a)](#a), which shall be as soon as practicable; and
    - (E) provide for a reasonable transition period.
  - (2) **Variability.—** As determined by the [Administrator](/usc/15/2602.md?p=1), the compliance dates established under [paragraph (1)](#d-1) may vary for different affected [persons](/usc/15/7a.md?p=6).
  - (3)
    - (A) The [Administrator](/usc/15/2602.md?p=1) may declare a proposed rule under [subsection (a)](#a) to be effective, and compliance with the proposed requirements to be mandatory, upon publication in the Federal Register of the proposed rule and until the compliance dates applicable to such requirements in a final rule promulgated under [section 2605(a) of this title](#a) or until the [Administrator](/usc/15/2602.md?p=1) revokes such proposed rule, in accordance with [subparagraph (B)](#d-3-B), if—
      - (i) the [Administrator](/usc/15/2602.md?p=1) determines that—
        - (I) the [manufacture](/usc/15/2602.md?p=9), processing, [distribution in commerce](/usc/15/2602.md?p=5), use, or disposal of the [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10) subject to such proposed rule or any combination of such activities is likely to result in an unreasonable risk of serious or widespread injury to health or the [environment](/usc/15/2602.md?p=6) 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](/usc/15/2602.md?p=9), processing, or distribution of a [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10) because of the risk determined under [clause (i)(I)](#d-3-A-i-I), a court has in an action under [section 2606 of this title](/usc/15/2606.md) granted relief with respect to such risk associated with such substance or [mixture](/usc/15/2602.md?p=10).

      Such a proposed rule which is made so effective shall not, for purposes of judicial review, be considered final agency action.

    - (B) If the [Administrator](/usc/15/2602.md?p=1) makes a proposed rule effective upon its publication in the Federal Register, the [Administrator](/usc/15/2602.md?p=1) shall, as expeditiously as possible, give interested [persons](/usc/15/7a.md?p=6) prompt notice of such action in accordance with [subsection (c)](#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](/usc/15/2602.md?p=1) shall promulgate rules to—
    - (A) prescribe methods for the disposal of polychlorinated biphenyls, and
    - (B) require polychlorinated biphenyls to be marked with clear and adequate warnings, and instructions with respect to their processing, [distribution in commerce](/usc/15/2602.md?p=5), use, or disposal or with respect to any combination of such activities.

    Requirements prescribed by rules under this paragraph shall be consistent with the requirements of paragraphs [(2)](#e-2) and [(3)](#e-3).

  - (2)
    - (A) Except as provided under [subparagraph (B)](#e-2-B), effective one year after January 1, 1977, no [person](/usc/15/7a.md?p=6) may [manufacture](/usc/15/2602.md?p=9), [process](/usc/15/2602.md?p=13), or [distribute in commerce](/usc/15/2602.md?p=5) or use any polychlorinated biphenyl in any manner other than in a totally enclosed manner.
    - (B) The [Administrator](/usc/15/2602.md?p=1) may by rule authorize the [manufacture](/usc/15/2602.md?p=9), processing, [distribution in commerce](/usc/15/2602.md?p=5) 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](/usc/15/2602.md?p=1) finds that such [manufacture](/usc/15/2602.md?p=9), processing, [distribution in commerce](/usc/15/2602.md?p=5), or use (or combination of such activities) will not present an unreasonable risk of injury to health or the [environment](/usc/15/2602.md?p=6).
    - (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](/usc/15/2602.md?p=6) to a polychlorinated biphenyl will be insignificant as determined by the [Administrator](/usc/15/2602.md?p=1) by rule.
  - (3)
    - (A) Except as provided in subparagraphs [(B)](#e-3-B) and [(C)](#e-3-C)—
      - (i) no [person](/usc/15/7a.md?p=6) may [manufacture](/usc/15/2602.md?p=9) any polychlorinated biphenyl after two years after January 1, 1977, and
      - (ii) no [person](/usc/15/7a.md?p=6) may [process](/usc/15/2602.md?p=13) or [distribute in commerce](/usc/15/2602.md?p=5) any polychlorinated biphenyl after two and one-half years after such date.
    - (B) Any [person](/usc/15/7a.md?p=6) may petition the [Administrator](/usc/15/2602.md?p=1) for an exemption from the requirements of [subparagraph (A)](#e-3-A), and the [Administrator](/usc/15/2602.md?p=1) may grant by rule such an exemption if the [Administrator](/usc/15/2602.md?p=1) finds that—
      - (i) an unreasonable risk of injury to health or [environment](/usc/15/2602.md?p=6) would not result, and
      - (ii) good faith efforts have been made to develop a [chemical substance](/usc/15/2602.md?p=2-A) which does not present an unreasonable risk of injury to health or the [environment](/usc/15/2602.md?p=6) 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](/usc/15/2602.md?p=1) may prescribe and shall be in effect for such period (but not more than one year from the date it is granted) as the [Administrator](/usc/15/2602.md?p=1) may prescribe.

    - (C) [Subparagraph (A)](#e-3-A) shall not apply to the [distribution in commerce](/usc/15/2602.md?p=5) 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)](#e-1), [(2)(B)](#e-2-B), or [(3)(B)](#e-3-B) shall be promulgated in accordance with [paragraph (3)](#c-3) of subsection (c).
  - (5) This subsection does not limit the authority of the [Administrator](/usc/15/2602.md?p=1), under any other provision of this chapter or any other Federal law, to take action respecting any polychlorinated biphenyl.
- (f) **Mercury—**
  - (1) **Prohibition on sale, distribution, or transfer of elemental mercury by Federal agencies—** Except as provided in [paragraph (2)](#f-2), effective beginning on October 14, 2008, no Federal agency shall convey, sell, or distribute to any other Federal agency, any [State](/usc/15/2602.md?p=16) or [local government](/usc/15/34.md?p=1) agency, or any private individual or entity any elemental mercury under the control or jurisdiction of the Federal agency.
  - (2) **Exceptions—** [Paragraph (1)](#f-1) shall not apply to—
    - (A) a transfer between Federal agencies of elemental mercury for the sole purpose of facilitating 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](/usc/15/2602.md?p=1) may, as part of a rule promulgated under [subsection (a)](#a), or in a separate rule, grant an exemption from a requirement of a [subsection (a)](#a) rule for a specific condition of use of a [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10), if the [Administrator](/usc/15/2602.md?p=1) finds that—
    - (A) the specific condition of use is a critical or essential use for which no technically and economically feasible safer alternative is available, taking into consideration hazard and exposure;
    - (B) compliance with the requirement, as applied with respect to the specific condition of use, would significantly disrupt the national economy, national security, or critical infrastructure; or
    - (C) the specific condition of use of the [chemical substance](/usc/15/2602.md?p=2-A) or [mixture](/usc/15/2602.md?p=10), as compared to reasonably available alternatives, provides a substantial benefit to health, the [environment](/usc/15/2602.md?p=6), or public safety.
  - (2) **Exemption analysis and statement—** In proposing an exemption under this subsection, the [Administrator](/usc/15/2602.md?p=1) 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](/usc/15/2602.md?p=1) 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](/usc/15/2602.md?p=1) as reasonable on a case-by-case basis, and, by rule, may extend, modify, or eliminate an exemption if the [Administrator](/usc/15/2602.md?p=1) determines, on the basis of reasonably available information and after adequate public justification, the exemption warrants extension or modification or is no longer necessary.
  - (4) **Conditions—** As part of a rule promulgated under this subsection, the [Administrator](/usc/15/2602.md?p=1) shall include conditions, including reasonable recordkeeping, monitoring, and reporting requirements, to the extent that the [Administrator](/usc/15/2602.md?p=1) determines the conditions are necessary to protect health and the [environment](/usc/15/2602.md?p=6) while achieving the purposes of the exemption.
- (h) **Chemicals that are persistent, bioaccumulative, and toxic—**
  - (1) **Expedited action—** Not later than 3 years after June 22, 2016, the [Administrator](/usc/15/2602.md?p=1) shall propose rules under [subsection (a)](#a) with respect to [chemical substances](/usc/15/2602.md?p=2-A) identified in the 2014 update of the TSCA Work Plan for Chemical Assessments—
    - (A) that the [Administrator](/usc/15/2602.md?p=1) has a reasonable basis to conclude are toxic and that with respect to persistence and bioaccumulation score high for one and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals Methods Document published by the [Administrator](/usc/15/2602.md?p=1) in February 2012 (or a successor scoring system), and are not a metal or a metal compound, and for which the [Administrator](/usc/15/2602.md?p=1) has not completed a Work Plan Problem Formulation, initiated a review under [section 5](/usc/15/5.md), or entered into a consent [agreement](/usc/15/7a.md?p=2) under [section 2603 of this title](/usc/15/2603.md), prior to June 22, 2016; and
    - (B) exposure to which under the [conditions of use](/usc/15/2602.md?p=4) is likely to the general population or to a [potentially exposed or susceptible subpopulation](/usc/15/2602.md?p=12) identified by the [Administrator](/usc/15/2602.md?p=1), or the [environment](/usc/15/2602.md?p=6), on the basis of an exposure and use assessment conducted by the [Administrator](/usc/15/2602.md?p=1).
  - (2) **No risk evaluation required—** The [Administrator](/usc/15/2602.md?p=1) shall not be required to conduct risk evaluations on [chemical substances](/usc/15/2602.md?p=2-A) that are subject to [paragraph (1)](#h-1).
  - (3) **Final rule—** Not later than 18 months after proposing a rule pursuant to [paragraph (1)](#h-1), the [Administrator](/usc/15/2602.md?p=1) shall promulgate a final rule under [subsection (a)](#a).
  - (4) **Selecting restrictions—** In selecting among prohibitions and other restrictions promulgated in a rule under [subsection (a)](#a) pursuant to [paragraph (1)](#h-1), the [Administrator](/usc/15/2602.md?p=1) shall address the risks of injury to health or the [environment](/usc/15/2602.md?p=6) that the [Administrator](/usc/15/2602.md?p=1) determines are presented by the [chemical substance](/usc/15/2602.md?p=2-A) 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](/usc/15/2602.md?p=1) makes a designation under [subsection (b)(1)(B)(i)](#b-1-B-i), or receives a request under [subsection (b)(4)(C)(ii)](#b-4-C-ii), such [chemical substance](/usc/15/2602.md?p=2-A) shall not be subject to this subsection, except that in selecting among prohibitions and other restrictions promulgated in a rule pursuant to [subsection (a)](#a), the [Administrator](/usc/15/2602.md?p=1) shall both ensure that the [chemical substance](/usc/15/2602.md?p=2-A) meets the rulemaking standard under [subsection (a)](#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](/usc/15/2617.md)—
  - (1) a determination by the [Administrator](/usc/15/2602.md?p=1) under [subsection (b)(4)(A)](#b-4-A) that a [chemical substance](/usc/15/2602.md?p=2-A) does not present an unreasonable risk of injury to health or the [environment](/usc/15/2602.md?p=6) 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)](#a), including the associated determination by the [Administrator](/usc/15/2602.md?p=1) under [subsection (b)(4)(A)](#b-4-A) that a [chemical substance](/usc/15/2602.md?p=2-A) presents an unreasonable risk of injury to health or the [environment](/usc/15/2602.md?p=6), shall be considered to be a final agency action, effective beginning on the date of promulgation of the final rule.
- (j) **Definition—** For the purposes of this chapter, the term “requirement” as used in this section shall not displace statutory or common law.

## Source credit

(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.)

## Notes

### 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 section catchline.

Subsec. (a). Pub. L. 114–182, § 6(2)(A)–(D), in introductory provisions, substituted “determines in accordance with subsection (b)(4)(A)” for “finds that there is a reasonable 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 subsection (c)(2),” after “shall by rule”.

Subsec. (a)(1)(A), (2)(A). Pub. L. 114–182, § 6(2)(E), inserted “or otherwise restricting” after “prohibiting”.

Subsec. (a)(3). Pub. L. 114–182, § 6(2)(F), inserted “minimum” 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 conduct 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 prevent unreasonable risk of injury to health or the environment.

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 effect, which date shall be as soon as feasible.” Former par. (2) redesignated (3).

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 introductory 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 requirements 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 Register 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), substituted “in accordance with subsection (c), and either promulgate such rule (as proposed or with modifications) or revoke it.” for “, provide reasonable opportunity, in accordance with paragraphs (2) and (3) of subsection (c), for a hearing on such rule, and either promulgate such rule (as proposed or with modifications) or revoke it; and if such a hearing is requested, the Administrator shall commence the hearing within five days from the date such request is made unless the Administrator 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 promulgate 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 subsecs. (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), temporarily substituted “but not more than 1 year from the date it is granted, except as provided in subparagraph (D)” for “but not more than one year from the date it is granted” in concluding provisions. See Termination Date of 2006 Amendment note below.

Subsec. (e)(3)(D). Pub. L. 109–364, § 317(a)(3), (b), temporarily added subpar. (D) which read as follows: “The Administrator may extend an exemption granted pursuant to subparagraph (B) that has not yet expired for a period not to exceed 60 days for the purpose of authorizing the Secretary of Defense and the Secretaries of the military departments to provide for the transportation into the customs territory of the United States of polychlorinated biphenyls generated by or under the control of the Department of Defense for purposes of their disposal, treatment, or storage in the customs territory of the United States if those polychlorinated 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 exemption. The Administrator shall promptly publish notice of such extension in the Federal Register.” See Termination 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 exemption 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.