1446.12_ss-Attachment-A_statute

§ 2605

TITLE 15—COMMERCE AND TRADE

(1). Such order shall take effect on the expiration of the
applicable review period.’’ for ‘‘under paragraph (1),
or’’, and struck out cl. (ii) and concluding provisions
which read as follows:
‘‘(ii) apply, through attorneys of the Environmental
Protection Agency, to the United States District Court
for the District of Columbia or the United States district court for the judicial district in which the manufacturer, or processor, as the case may be, of such substance, is found, resides, or transacts business for an
injunction to prohibit the manufacture, processing, or
distribution in commerce of such substance.
A proposed order issued under clause (i) respecting a
chemical substance shall take effect on the expiration
of the notification period applicable under subsection
(a), (b), or (c) to the manufacture or processing of such
substance.’’
Subsec. (f)(3)(B), (C). Pub. L. 114–182, § 5(6)(C)(ii), (iii),
redesignated subpar. (C) as (B), substituted ‘‘subparagraph (B)’’ for ‘‘subparagraphs (B) and (C)’’, struck out
‘‘clause (i) of’’ after ‘‘order issued under’’ and ‘‘; and
the provisions of subparagraph (C) of subsection (e)(2)
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 application 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 combination of such activities, presents or will present an
unreasonable risk of injury to health or the environment 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, processing, 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 Administrator issues an order pursuant to subparagraph (A)(i)
respecting a chemical substance and objections are
filed in accordance with subsection (e)(1)(C), the Administrator shall seek an injunction under subparagraph (A)(ii) respecting such substance unless the Administrator determines, on the basis of such objections,
that such substance does not or will not present an unreasonable risk of injury to health or the environment.’’
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 prohibit 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 reasons for not initiating such action. Such a statement
shall be published in the Federal Register before the
expiration of such period. Publication of such statement 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 exposed or susceptible subpopulation identified by the
Administrator for the specific conditions of use identified in the application’’ after ‘‘health or the environment’’.
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 potentially exposed or susceptible subpopulation identi-

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fied by the Administrator under the conditions of use’’
for ‘‘environment. A rule promulgated under this paragraph (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.’’
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 regulation 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, presents 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 otherwise restricting the manufacturing, processing, 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 distributed 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 specified by the Administrator in the rule imposing 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 substance or mixture be marked with or accompanied by clear and adequate minimum warnings 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 warnings 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 mixture or monitor or conduct tests which are
reasonable and necessary to assure compliance
with the requirements of any rule applicable
under this subsection.

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TITLE 15—COMMERCE AND TRADE

(5) A requirement prohibiting or otherwise
regulating any manner or method of commercial use of such substance or mixture.
(6)(A) A requirement prohibiting or otherwise regulating any manner or method of disposal 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 requirement of, or in effect for, a State or political 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)
to give notice of such determination to distributors in commerce of such substance or
mixture and, to the extent reasonably ascertainable, to other persons in possession of such
substance or mixture or exposed to such substance or mixture, (B) to give public notice of
such determination, and (C) to replace or repurchase such substance or mixture as elected
by the person 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 shall establish, by rule, a
risk-based screening process, including criteria for designating chemical substances as
high-priority substances for risk evaluations
or low-priority substances for which risk
evaluations are not warranted at the time.
The process to designate the priority of
chemical substances shall include a consideration of the hazard and exposure potential
of a chemical substance or a category of
chemical substances (including consideration of persistence and bioaccumulation,
potentially exposed or susceptible subpopulations and storage near significant sources
of drinking water), the conditions of use or
significant changes in the conditions of use
of the chemical substance, and the volume
or significant changes in the volume of the
chemical substance manufactured or processed.
(B) Identification of priorities for risk evaluation
(i) High-priority substances
The Administrator shall designate as a
high-priority substance a chemical substance that the Administrator concludes,
without consideration of costs or other
nonrisk factors, may present an unreasonable risk of injury to health or the environment because of a potential hazard and

§ 2605

a potential route of exposure under the
conditions of use, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant by the Administrator.
(ii) Low-priority substances
The Administrator shall designate a
chemical substance as a low-priority substance if the Administrator concludes,
based on information sufficient to establish, without consideration of costs or
other nonrisk factors, that such substance
does not meet the standard identified in
clause (i) for designating a chemical substance a high-priority substance.
(C) Information request and review and proposed and final prioritization designation
The rulemaking required in subparagraph
(A) shall ensure that the time required to
make a priority designation of a chemical
substance be no shorter than nine months
and no longer than 1 year, and that the process for such designations includes—
(i) a requirement that the Administrator
request interested persons to submit relevant information on a chemical substance
that the Administrator has initiated the
prioritization process on, before proposing
a priority designation for the chemical
substance, and provide 90 days for such information to be provided;
(ii) a requirement that the Administrator publish each proposed designation
of a chemical substance as a high- or lowpriority 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 by which the Administrator may extend the deadline in clause
(i) for up to three months in order to receive or evaluate information required to
be submitted in accordance with section
2603(a)(2)(B) of this title, subject to the
limitation that if the information available to the Administrator at the end of
such an extension remains insufficient to
enable the designation of the chemical
substance as a low-priority substance, the
Administrator shall designate the chemical substance as a high-priority substance.
(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 shall ensure that risk
evaluations are being conducted on 10 chemical substances drawn from the 2014 update
of the TSCA Work Plan for Chemical Assessments and shall publish the list of such
chemical substances during the 180 day period.
(B) Additional risk evaluations
Not later than three and one half years
after June 22, 2016, the Administrator shall

§ 2605

TITLE 15—COMMERCE AND TRADE

ensure that risk evaluations are being conducted on at least 20 high-priority substances and that at least 20 chemical substances have been designated as low-priority
substances, subject to the limitation that at
least 50 percent of all chemical substances
on which risk evaluations are being conducted by the Administrator are drawn from
the 2014 update of the TSCA Work Plan for
Chemical Assessments.
(C) Continuing designations and risk evaluations
The Administrator shall continue to designate priority substances and conduct risk
evaluations in accordance with this subsection at a pace consistent with the ability
of the Administrator to complete risk evaluations in accordance with the deadlines
under paragraph (4)(G).
(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 Persistence 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 evaluation and conducting risk evaluations of metals and metal compounds, the Administrator
shall use the Framework for Metals Risk Assessment of the Office of the Science Advisor, Risk Assessment Forum, and dated
March 2007, or a successor document that addresses metals risk assessment and is peer
reviewed by the Science Advisory Board.
(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 substance.
(B) Revision
The Administrator may revise the designation of a low-priority substance based on information made available to the Administrator.
(C) Ongoing designations
The Administrator shall designate at least
one high-priority substance upon the completion of each risk evaluation (other than
risk evaluations for chemical substances
designated under paragraph (4)(C)(ii)).
(4) Risk evaluation process and deadlines
(A) In general
The Administrator shall conduct risk evaluations pursuant to this paragraph to determine whether a chemical substance presents
an unreasonable risk of injury to health or
the environment, without consideration of
costs or other nonrisk factors, including an

Page 1716

unreasonable risk to a potentially exposed
or susceptible subpopulation identified as
relevant to the risk evaluation by the Administrator, 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 accordance with subparagraph (A).
(C) Requirement
The Administrator shall conduct and publish risk evaluations, in accordance with the
rule promulgated under subparagraph (B),
for a chemical substance—
(i) that has been identified under paragraph (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 Administrator 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 evaluation, publish the scope of the risk evaluation
to be conducted, including the hazards, exposures, conditions of use, and the potentially
exposed or susceptible subpopulations the
Administrator expects to consider, and, for
each designation of a high-priority substance, ensure not less than 12 months between the initiation of the prioritization
process for the chemical substance and the
publication of the scope of the risk evaluation for the chemical substance, and for risk
evaluations conducted on chemical substances that have been identified under
paragraph (2)(A) or selected under subparagraph (E)(iv)(II) of this paragraph, ensure
not less than 3 months before the Administrator publishes the scope of the risk evaluation.
(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 chemical substances undergoing a risk evaluation 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 subparagraph (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-

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TITLE 15—COMMERCE AND TRADE

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 significant impact on interstate commerce or
health or the environment.
(iv) Exceptions
(I) Chemical substances for which requests have been granted under subparagraph (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 Administrator and not be subject to clause (i)(II).
(F) Requirements
In conducting a risk evaluation under this
subsection, the Administrator shall—
(i) integrate and assess available information on hazards and exposures for the
conditions of use of the chemical substance, including information that is relevant to specific risks of injury to health
or the environment and information on potentially exposed or susceptible subpopulations identified as relevant by the Administrator;
(ii) describe whether aggregate or sentinel exposures to a chemical substance
under the conditions of use 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 of the chemical substance; and
(v) describe the weight of the scientific
evidence for the identified hazard and exposure.
(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 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 determines that a
chemical substance presents an unreasonable
risk of injury to health or the environment in
accordance with subsection (b)(4)(A), the Administrator—
(A) shall propose in the Federal Register a
rule under subsection (a) for the chemical

§ 2605

substance not later than 1 year after the
date on which the final risk evaluation regarding 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 regarding 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 subsection (b)(4)(G)(ii) does not exceed 2 years,
and subject to the limitation that the Administrator may not extend a deadline for
the publication of a proposed or final rule regarding a chemical substance drawn from
the 2014 update of the TSCA Work Plan for
Chemical Assessments or a chemical substance that, with respect to persistence and
bioaccumulation, scores high for 1 and either high or moderate for the other, pursuant to the TSCA Work Plan Chemicals
Methods Document published by the Administrator in February 2012 (or a successor
scoring system), without adequate public
justification that demonstrates, following a
review of the information reasonably available to the Administrator, that the Administrator cannot complete the proposed or final
rule without additional information regarding the chemical substance.
(2) Requirements for rule
(A) Statement of effects
In proposing and promulgating a rule
under subsection (a) with respect to a chemical substance or mixture, the Administrator
shall consider and publish a statement based
on reasonably available information with respect to—
(i) the effects of the chemical substance
or mixture on health and the magnitude of
the exposure of human beings to the chemical substance or mixture;
(ii) the effects of the chemical substance
or mixture on the environment and the
magnitude of the exposure of the environment to such substance or mixture;
(iii) the benefits of the chemical substance or mixture 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,
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; and
(III) the cost effectiveness of the proposed regulatory action and of the 1 or
more primary alternative regulatory actions considered by the Administrator.
(B) Selecting requirements
In selecting among prohibitions and other
restrictions, the Administrator shall factor

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TITLE 15—COMMERCE AND TRADE

in, to the extent practicable, the considerations under subparagraph (A) in accordance
with subsection (a).
(C) Consideration of alternatives

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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 rulemaking stating with particularity the reason for the proposed rule;
(B) allow interested persons 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).

Based on the information published under
subparagraph (A), in deciding whether to
prohibit or restrict in a manner that substantially prevents a specific condition of
use of a chemical substance or mixture, and
in setting an appropriate transition period
for such action, the Administrator shall consider, to the extent practicable, whether
technically and economically feasible alternatives that benefit health or the environment, compared to the use so proposed to be
prohibited or restricted, will be reasonably
available as a substitute when the proposed
prohibition or other restriction takes effect.
(D) Replacement parts
(i) In general
The Administrator shall exempt replacement parts for complex durable goods and
complex consumer goods that are designed
prior to the date of publication in the Federal Register of the rule under subsection
(a), unless the Administrator finds that
such replacement parts contribute significantly to the risk, identified in a risk evaluation
conducted
under
subsection
(b)(4)(A), to the general population or to
an identified potentially exposed or susceptible subpopulation.
(ii) Definitions
In this subparagraph—
(I) the term ‘‘complex consumer
goods’’ means electronic or mechanical
devices composed of multiple manufactured components, with an intended useful life of 3 or more years, where the
product is typically not consumed, destroyed, or discarded after a single use,
and the components of which would be
impracticable to redesign or replace; and
(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 substance or mixture from the article or category of articles so that the substance or
mixture does not present an unreasonable
risk of injury to health or the environment
identified in the risk evaluation conducted
in accordance with subsection (b)(4)(A).
(3) Procedures

(2) VARIABILITY.—As determined by the Administrator, the compliance dates established
under paragraph (1) may vary for different affected persons.
(3)(A) The Administrator may declare a proposed rule under subsection (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 or until the Administrator
revokes such proposed rule, in accordance with
subparagraph (B), if—
(i) the Administrator determines that—
(I) the manufacture, processing, distribution 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 unreasonable risk of serious or widespread injury 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

When prescribing a rule under subsection (a)
the Administrator shall proceed in accordance

(ii) in the case of a proposed rule to prohibit
the manufacture, processing, or distribution of

(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 practicable;
(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 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);
(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 requirements under a rule under subsection (a),
which shall be as soon as practicable; and
(E) provide for a reasonable transition period.

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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 associated with such substance or mixture.
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 makes a proposed
rule effective upon its publication in the Federal
Register, the Administrator shall, as expeditiously 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
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, 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) 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 manufacture, 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 polychlorinated biphenyl will be insignificant as determined by the Administrator by rule.
(3)(A) Except as provided in subparagraphs (B)
and (C)—
(i) no person may manufacture any polychlorinated 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 Administrator for an exemption from the requirements
of subparagraph (A), and the Administrator may
grant by rule such an exemption if the Administrator finds that—
(i) an unreasonable risk of injury to health
or environment would not result, and
(ii) good faith efforts have been made to develop a chemical substance which does not
present an unreasonable risk of injury to

§ 2605

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 Administrator 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 authority of the Administrator, 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), effective
beginning on October 14, 2008, no Federal agency shall convey, sell, or distribute to any
other Federal agency, any State or local government agency, or any private individual or
entity any elemental mercury under the control 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 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 may, as part of a rule
promulgated under subsection (a), or in a separate rule, grant an exemption from a requirement of a subsection (a) rule for a specific condition of use of a chemical substance or mixture, if the Administrator finds that—
(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 or mixture, as compared
to reasonably available alternatives, provides a substantial benefit to health, the environment, or public safety.
(2) Exemption analysis and statement
In proposing an exemption under this subsection, the Administrator shall analyze the

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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-bycase basis, and, by rule, may extend, modify,
or eliminate an exemption if the Administrator determines, on the basis of reasonably
available information and after adequate public justification, the exemption warrants extension or modification or is no longer necessary.
(4) Conditions
As part of a rule promulgated under this
subsection, the Administrator shall include
conditions,
including
reasonable
recordkeeping, monitoring, and reporting requirements, to the extent that the Administrator
determines the conditions are necessary to
protect health and the environment while
achieving the purposes of the exemption.
(h) Chemicals that are persistent, bioaccumulative, and toxic
(1) Expedited action
Not later than 3 years after June 22, 2016, the
Administrator shall propose rules under subsection (a) with respect to chemical substances identified in the 2014 update of the
TSCA Work Plan for Chemical Assessments—
(A) that the Administrator has a reasonable basis to conclude are toxic and that
with respect to persistence and bioaccumulation score high for one and either high or
moderate for the other, pursuant to the
TSCA Work Plan Chemicals Methods Document published by the Administrator in February 2012 (or a successor scoring system),
and are not a metal or a metal compound,
and for which the Administrator has not
completed a Work Plan Problem Formulation, initiated a review under section 5, or
entered into a consent agreement under section 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 subpopulation identified by the Administrator,
or the environment, on the basis of an exposure and use assessment conducted by the
Administrator.
(2) No risk evaluation required
The Administrator shall not be required to
conduct risk evaluations on chemical substances that are subject to paragraph (1).
(3) Final rule
Not later than 18 months after proposing a
rule pursuant to paragraph (1), the Administrator shall promulgate a final rule under subsection (a).
(4) Selecting restrictions
In selecting among prohibitions and other
restrictions promulgated in a rule under subsection (a) pursuant to paragraph (1), the Ad-

Page 1720

ministrator shall address the risks of injury to
health or the environment that the Administrator determines are presented by the chemical substance and shall reduce exposure to the
substance to the extent practicable.
(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 subsection (b)(4)(C)(ii), such chemical substance
shall not be subject to this subsection, except
that in selecting among prohibitions and other
restrictions promulgated in a rule pursuant to
subsection (a), the Administrator shall both
ensure that the chemical substance meets the
rulemaking standard under subsection (a) and
reduce exposure to the substance to the extent
practicable.
(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 substance does not present an unreasonable risk
of injury to health or the environment shall be
issued by order and considered to be a final
agency action, effective beginning on the date
of issuance of the order; and
(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 unreasonable risk of injury to health or the environment, shall be considered to be a final agency
action, effective beginning on the date of promulgation of the final rule.
(j) Definition
For the purposes of this chapter, the term ‘‘requirement’’ as used in this section shall not displace 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.)
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’’.

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TITLE 15—COMMERCE AND TRADE

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 nonrisk 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 poly-

§ 2606

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 exemption. The Administrator shall promptly publish notice
of such extension in the Federal Register.’’ See Termination Date of 2006 Amendment note below.
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.

§ 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 chemical substance or mixture or any article containing 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 section 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 containing 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 protect health or the environment from the unreasonable 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 chemi-