Attachment A

§ 2604

TITLE 15—COMMERCE AND TRADE

Subsec. (c)(3)(A)(i). Pub. L. 114–182, § 4(4)(C), substituted ‘‘submitted such information’’ for ‘‘submitted
such test data’’ and ‘‘submit such information’’ for
‘‘submit such data’’.
Subsec. (c)(3)(B). Pub. L. 114–182, § 4(4)(C)(i), substituted ‘‘information’’ for ‘‘test data’’ in introductory
provisions.
Subsec. (c)(3)(B)(i). Pub. L. 114–182, § 19(d)(2)(C), substituted ‘‘rule, order, or consent agreement’’ for ‘‘rule
promulgated’’.
Pub. L. 114–182, § 4(4)(C)(ii), substituted ‘‘such information’’ for ‘‘such data’’.
Subsec. (c)(3)(B)(ii)(II). Pub. L. 114–182, § 4(4)(C)(ii),
substituted ‘‘such information’’ for ‘‘such data’’.
Subsec. (c)(4). Pub. L. 114–182, § 19(d)(2)(D)(i), (ii), substituted ‘‘pursuant to a rule, order, or consent agreement’’ for ‘‘pursuant to a rule promulgated’’ in two
places and ‘‘such rule, order, or consent agreement’’ for
‘‘such rule’’ wherever appearing.
Pub. L. 114–182, § 4(4)(D), substituted ‘‘information’’
for ‘‘test data’’ wherever appearing.
Subsec. (c)(4)(B). Pub. L. 114–182, § 19(d)(2)(D)(iii), substituted ‘‘the rule or order’’ for ‘‘the rule’’.
Subsec. (d). Pub. L. 114–182, § 19(d)(3), substituted
‘‘rule, order, or consent agreement’’ for ‘‘rule’’.
Pub. L. 114–182, § 4(5), substituted ‘‘any information’’
for ‘‘any test data’’, ‘‘development of information’’ for
‘‘development of test data’’, ‘‘nature of the information’’ for ‘‘nature of the test data’’, and ‘‘for which information has’’ for ‘‘for which data have’’, and substituted ‘‘such information’’ for ‘‘such data’’ in two
places.
Pub. L. 114–182, § 4(1), substituted ‘‘protocols and
methodologies’’ for ‘‘standards’’.
Subsec. (e)(1)(A). Pub. L. 114–182, § 4(6)(A)(i)(I), substituted ‘‘development of information’’ for ‘‘promulgation of a rule’’ in introductory provisions.
Subsec.
(e)(1)(A)(vi),
(vii).
Pub.
L.
114–182,
§ 4(6)(A)(i)(II), substituted ‘‘information’’ for ‘‘data’’.
Subsec. (e)(1)(B). Pub. L. 114–182, § 4(6)(A)(ii), substituted ‘‘issue an order, enter into a consent agreement, or initiate a rulemaking proceeding under subsection (a), or, if such an order or consent agreement is
not issued or such a proceeding is not initiated within
such period, publish in the Federal Register the Administrator’s reason for not issuing such an order, entering
into such a consent agreement, or initiating such a proceeding’’ for ‘‘either initiate a rulemaking proceeding
under subsection (a) or if such a proceeding is not initiated within such period, publish in the Federal Register
the Administrator’s reason for not initiating such a
proceeding’’.
Subsec. (e)(2)(A). Pub. L. 114–182, § 4(6)(B)(i), substituted ‘‘ten members’’ for ‘‘eight members’’ in introductory provisions.
Subsec. (e)(2)(A)(ix), (x). Pub. L. 114–182, § 4(6)(B)(ii),
added cls. (ix) and (x).
Subsec. (f). Pub. L. 114–182, § 4(7)(B), in concluding
provisions, struck out ‘‘or will present’’ after ‘‘mixture
presents’’ and ‘‘from cancer, gene mutations, or birth
defects’’ after ‘‘human beings’’, substituted ‘‘applicable’’ for ‘‘appropriate’’, and inserted ‘‘, made without
consideration of costs or other nonrisk factors,’’ after
‘‘publish in the Federal Register a finding’’.
Subsec. (f)(1). Pub. L. 114–182, § 4(7)(A), substituted
‘‘information’’ for ‘‘test data’’.
Subsec. (g). Pub. L. 114–182, § 19(d)(4), substituted
‘‘rule, order, or consent agreement’’ for ‘‘rule’’.
Pub. L. 114–182, § 4(8), substituted ‘‘Petition for protocols and methodologies for the development of information’’ for ‘‘Petition for standards for the development
of test data’’ in heading and ‘‘submit information’’ for
‘‘submit data’’ and ‘‘development of information’’ for
‘‘development of test data’’ in text.
Pub. L. 114–182, § 4(1), substituted ‘‘protocols and
methodologies’’ for ‘‘standards’’ in two places.
Subsec. (h). Pub. L. 114–182, § 4(9), added subsec. (h).
EFFECTIVE DATE
Section effective Jan. 1, 1977, except as provided in
subsec. (f) of this section, see section 31 of Pub. L.
94–469, set out as a note under section 2601 of this title.

Page 1708

§ 2604. Manufacturing and processing notices
(a) In general
(1)(A) Except as provided in subparagraph (B)
of this paragraph and subsection (h), no person
may—
(i) manufacture a new chemical substance on
or after the 30th day after the date on which
the Administrator first publishes the list required by section 2607(b) of this title, or
(ii) manufacture or process any chemical
substance for a use which the Administrator
has determined, in accordance with paragraph
(2), is a significant new use.
(B) A person may take the actions described in
subparagraph (A) if—
(i) such person submits to the Administrator, at least 90 days before such manufacture or processing, a notice, in accordance
with subsection (d), of such person’s intention
to manufacture or process such substance and
such person complies with any applicable requirement of, or imposed pursuant to, subsection (b), (e), or (f); and
(ii) the Administrator—
(I) conducts a review of the notice; and
(II) makes a determination under subparagraph (A), (B), or (C) of paragraph (3) and
takes the actions required in association
with that determination under such subparagraph within the applicable review period.
(2) A determination by the Administrator that
a use of a chemical substance is a significant
new use with respect to which notification is required under paragraph (1) shall be made by a
rule promulgated after a consideration of all relevant factors, including—
(A) the projected volume of manufacturing
and processing of a chemical substance,
(B) the extent to which a use changes the
type or form of exposure of human beings or
the environment to a chemical substance,
(C) the extent to which a use increases the
magnitude and duration of exposure of human
beings or the environment to a chemical substance, and
(D) the reasonably anticipated manner and
methods of manufacturing, processing, distribution in commerce, and disposal of a
chemical substance.
(3) REVIEW AND DETERMINATION.—Within the
applicable review period, subject to section 2617
of this title, the Administrator shall review
such notice and determine—
(A) that the relevant chemical substance or
significant new use presents an unreasonable
risk of injury to health or the environment,
without consideration of costs or other
nonrisk factors, including an unreasonable
risk to a potentially exposed or susceptible
subpopulation identified as relevant by the
Administrator under the conditions of use, in
which case the Administrator shall take the
actions required under subsection (f);
(B) that—
(i) the information available to the Administrator is insufficient to permit a reasoned
evaluation of the health and environmental
effects of the relevant chemical substance or
significant new use; or

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TITLE 15—COMMERCE AND TRADE

(ii)(I) in the absence of sufficient information to permit the Administrator to make
such an evaluation, the manufacture, processing, distribution in commerce, use, or disposal of such substance, or any combination
of such activities, may present an unreasonable risk of injury to health or the environment, without consideration of costs or
other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant
by the Administrator; or
(II) such substance is or will be produced
in substantial quantities, and such substance either enters or may reasonably be
anticipated to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to
the substance,
in which case the Administrator shall take the
actions required under subsection (e); or
(C) that the relevant chemical substance or
significant new use is not likely to present an
unreasonable risk of injury to health or the
environment, without consideration of costs
or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant
by the Administrator under the conditions of
use, in which case the submitter of the notice
may commence manufacture of the chemical
substance or manufacture or processing for a
significant new use.
(4) FAILURE TO RENDER DETERMINATION.—
(A) FAILURE TO RENDER DETERMINATION.—If
the Administrator fails to make a determination on a notice under paragraph (3) by the end
of the applicable review period and the notice
has not been withdrawn by the submitter, the
Administrator shall refund to the submitter
all applicable fees charged to the submitter for
review of the notice pursuant to section 2625(b)
of this title, and the Administrator shall not
be relieved of any requirement to make such
determination.
(B) LIMITATIONS.—(i) A refund of applicable
fees under subparagraph (A) shall not be made
if the Administrator certifies that the submitter has not provided information required
under subsection (b) or has otherwise unduly
delayed the process such that the Administrator is unable to render a determination
within the applicable review period.
(ii) A failure of the Administrator to render
a decision shall not be deemed to constitute a
withdrawal of the notice.
(iii) Nothing in this paragraph shall be construed as relieving the Administrator or the
submitter of the notice from any requirement
of this section.
(5) ARTICLE CONSIDERATION.—The Administrator may require notification under this section for the import or processing of a chemical
substance as part of an article or category of articles under paragraph (1)(A)(ii) if the Administrator makes an affirmative finding in a rule
under paragraph (2) that the reasonable potential for exposure to the chemical substance
through the article or category of articles subject to the rule justifies notification.

§ 2604

(b) Submission of information
(1)(A) If (i) a person is required by subsection
(a)(1) to submit a notice to the Administrator
before beginning the manufacture or processing
of a chemical substance, and (ii) such person is
required to submit information for such substance pursuant to a rule, order, or consent
agreement under section 2603 of this title before
the submission of such notice, such person shall
submit to the Administrator such information
in accordance with such rule, order, or consent
agreement at the time notice is submitted in accordance with subsection (a)(1).
(B) If—
(i) a person is required by subsection (a)(1)
to submit a notice to the Administrator, and
(ii) such person has been granted an exemption under section 2603(c) of this title from the
requirements of a rule or order under section
2603 of this title before the submission of such
notice,
such person may not, before the expiration of
the 90 day period which begins on the date of the
submission in accordance with such rule of the
information the submission or development of
which was the basis for the exemption, manufacture such substance if such person is subject to
subsection (a)(1)(A)(i) or manufacture or process
such substance for a significant new use if the
person is subject to subsection (a)(1)(A)(ii).
(2)(A) If a person—
(i) is required by subsection (a)(1) to submit
a notice to the Administrator before beginning
the manufacture or processing of a chemical
substance listed under paragraph (4), and
(ii) is not required by a rule, order, or consent agreement under section 2603 of this title
before the submission of such notice to submit
information for such substance,
such person may submit to the Administrator
information prescribed by subparagraph (B) at
the time notice is submitted in accordance with
subsection (a)(1).
(B) Information submitted pursuant to subparagraph (A) shall be information which the
person submitting the information believes
shows that—
(i) in the case of a substance with respect to
which notice is required under subsection
(a)(1)(A)(i), the manufacture, processing, distribution in commerce, use, and disposal of
the chemical substance or any combination of
such activities will not present an unreasonable risk of injury to health or the environment, or
(ii) in the case of a chemical substance with
respect to which notice is required under subsection (a)(1)(A)(ii), the intended significant
new use of the chemical substance will not
present an unreasonable risk of injury to
health or the environment.
(3) Information submitted under paragraph (1)
or (2) of this subsection or under subsection (e)
shall be made available, subject to section 2613
of this title, for examination by interested persons.
(4)(A)(i) The Administrator may, by rule, compile and keep current a list of chemical substances with respect to which the Administrator

§ 2604

TITLE 15—COMMERCE AND TRADE

finds that the manufacture, processing, distribution in commerce, use, or disposal, or any combination of such activities, presents or may
present an unreasonable risk of injury to health
or the environment, without consideration of
costs or other nonrisk factors.
(ii) In making a finding under clause (i) that
the manufacture, processing, distribution in
commerce, use, or disposal of a chemical substance or any combination of such activities
presents or may present an unreasonable risk of
injury to health or the environment, the Administrator shall consider all relevant factors, including—
(I) the effects of the chemical substance on
health and the magnitude of human exposure
to such substance; and
(II) the effects of the chemical substance on
the environment and the magnitude of environmental exposure to such substance.
(B) The Administrator shall, in prescribing a
rule under subparagraph (A) which lists any
chemical substance, identify those uses, if any,
which the Administrator determines, by rule
under subsection (a)(2), would constitute a significant new use of such substance.
(C) Any rule under subparagraph (A), and any
substantive amendment or repeal of such a rule,
shall be promulgated pursuant to the procedures
specified in section 553 of title 5.
(c) Extension of review period
The Administrator may for good cause extend
for additional periods (not to exceed in the aggregate 90 days) the period, prescribed by subsection (a) or (b). Subject to section 2613 of this
title, such an extension and the reasons therefor
shall be published in the Federal Register and
shall constitute a final agency action subject to
judicial review.
(d) Content of notice; publications in the Federal
Register
(1) The notice required by subsection (a) shall
include—
(A) insofar as known to the person submitting the notice or insofar as reasonably ascertainable, the information described in subparagraphs (A), (B), (C), (D), (F), and (G) of
section 2607(a)(2) of this title, and
(B) in such form and manner as the Administrator may prescribe, any information in the
possession or control of the person giving such
notice which are related to the effect of any
manufacture, processing, distribution in commerce, use, or disposal of such substance or
any article containing such substance, or of
any combination of such activities, on health
or the environment, and
(C) a description of any other information
concerning the environmental and health effects of such substance, insofar as known to
the person making the notice or insofar as
reasonably ascertainable.
Such a notice shall be made available, subject to
section 2613 of this title, for examination by interested persons.
(2) Subject to section 2613 of this title, not
later than five days (excluding Saturdays, Sundays and legal holidays) after the date of the receipt of a notice under subsection (a) or of infor-

Page 1710

mation under subsection (b), the Administrator
shall publish in the Federal Register a notice
which—
(A) identifies the chemical substance for
which notice or information has been received;
(B) lists the uses of such substance identified
in the notice; and
(C) in the case of the receipt of information
under subsection (b), describes the nature of
the tests performed on such substance and any
information which was developed pursuant to
subsection (b) or a rule, order, or consent
agreement under section 2603 of this title.
A notice under this paragraph respecting a
chemical substance shall identify the chemical
substance by generic class unless the Administrator determines that more specific identification is required in the public interest.
(3) At the beginning of each month the Administrator shall publish a list in the Federal Register of (A) each chemical substance for which
notice has been received under subsection (a)
and for which the applicable review period has
not expired, and (B) each chemical substance for
which such period has expired since the last publication in the Federal Register of such list.
(e) Regulation pending development of information
(1) 1 (A) If the Administrator determines that—
(i) the information available to the Administrator is insufficient to permit a reasoned
evaluation of the health and environmental effects of a chemical substance with respect to
which notice is required by subsection (a); or
(ii)(I) in the absence of sufficient information to permit the Administrator to make
such an evaluation, the manufacture, processing, distribution in commerce, use, or disposal
of such substance, or any combination of such
activities, may present an unreasonable risk
of injury to health or the environment, without consideration of costs or other nonrisk
factors, including an unreasonable risk to a
potentially exposed subpopulation identified
as relevant by the Administrator under the
conditions of use; or
(II) such substance is or will be produced in
substantial quantities, and such substance either enters or may reasonably be anticipated
to enter the environment in substantial quantities or there is or may be significant or substantial human exposure to the substance,
the Administrator shall issue an order, to take
effect on the expiration of the applicable review
period, to prohibit or limit the manufacture,
processing, distribution in commerce, use, or
disposal of such substance or to prohibit or limit
any combination of such activities to the extent
necessary to protect against an unreasonable
risk of injury to health or the environment,
without consideration of costs or other nonrisk
factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation
identified as relevant by the Administrator
under the conditions of use, and the submitter of
the notice may commence manufacture of the
chemical substance, or manufacture or process1 So

in original. There is no par. (2).

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TITLE 15—COMMERCE AND TRADE

ing of the chemical substance for a significant
new use, including while any required information is being developed, only in compliance with
the order.
(B) An order may not be issued under subparagraph (A) respecting a chemical substance (i)
later than 45 days before the expiration of the
applicable review period, and (ii) unless the Administrator has, on or before the issuance of the
order, notified, in writing, each manufacturer or
processor, as the case may be, of such substance
of the determination which underlies such order.
(f) Protection against unreasonable risks
(1) If the Administrator determines that a
chemical substance or significant new use with
respect to which notice is required by subsection
(a) presents an unreasonable risk of injury to
health or environment, without consideration of
costs or other nonrisk factors, including an unreasonable risk to a potentially exposed subpopulation identified as relevant by the Administrator under the conditions of use, the Administrator shall, before the expiration of the applicable review period, take the action authorized by
paragraph (2) or (3) to the extent necessary to
protect against such risk.
(2) The Administrator may issue a proposed
rule under section 2605(a) of this title to apply
to a chemical substance with respect to which a
finding was made under paragraph (1)—
(A) a requirement limiting the amount of
such substance which may be manufactured,
processed, or distributed in commerce,
(B) a requirement described in paragraph (2),
(3), (4), (5), (6), or (7) of section 2605(a) of this
title, or
(C) any combination of the requirements referred to in subparagraph (B).
Such a proposed rule shall be effective upon its
publication in the Federal Register. Section
2605(d)(3)(B) of this title shall apply with respect
to such rule.
(3)(A) The Administrator may issue an order
to prohibit or limit the manufacture, processing, or distribution in commerce of a substance
with respect to which a finding was made under
paragraph (1). Such order shall take effect on
the expiration of the applicable review period.
(B) The provisions of subparagraph (B) of subsection (e)(1) shall apply with respect to an
order issued under subparagraph (A).
(4) TREATMENT OF NONCONFORMING USES.—Not
later than 90 days after taking an action under
paragraph (2) or (3) or issuing an order under
subsection (e) relating to a chemical substance
with respect to which the Administrator has
made a determination under subsection (a)(3)(A)
or (B), the Administrator shall consider whether
to promulgate a rule pursuant to subsection
(a)(2) that identifies as a significant new use any
manufacturing, processing, use, distribution in
commerce, or disposal of the chemical substance
that does not conform to the restrictions imposed by the action or order, and, as applicable,
initiate such a rulemaking or publish a statement describing the reasons of the Administrator for not initiating such a rulemaking.
(5) WORKPLACE EXPOSURES.—To the extent
practicable, the Administrator shall consult
with the Assistant Secretary of Labor for Occu-

§ 2604

pational Safety and Health prior to adopting
any prohibition or other restriction relating to
a chemical substance with respect to which the
Administrator has made a determination under
subsection (a)(3)(A) or (B) to address workplace
exposures.
(g) Statement on Administrator finding
If the Administrator finds in accordance with
subsection (a)(3)(C) that a chemical substance or
significant new use is not likely to present an
unreasonable risk of injury to health or the environment, then notwithstanding any remaining
portion of the applicable review period, the submitter of the notice may commence manufacture of the chemical substance or manufacture
or processing for the significant new use, and
the Administrator shall make public a statement of the Administrator’s finding. Such a
statement shall be submitted for publication in
the Federal Register as soon as is practicable
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.
(h) Exemptions
(1) The Administrator may, upon application,
exempt any person from any requirement of subsection (a) or (b) to permit such person to manufacture or process a chemical substance for test
marketing purposes—
(A) upon a showing by such person satisfactory to the Administrator that the manufacture, processing, distribution in commerce,
use, and disposal of such substance, and that
any combination of such activities, for such
purposes will not present any unreasonable
risk of injury to health or the environment,
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, and
(B) under such restrictions as the Administrator considers appropriate.
(2)(A) The Administrator may, upon application, exempt any person from the requirement
of subsection (b)(2) to submit information for a
chemical substance. If, upon receipt of an application under the preceding sentence, the Administrator determines that—
(i) the chemical substance with respect to
which such application was submitted is
equivalent to a chemical substance for which
information has been submitted to the Administrator as required by subsection (b)(2), and
(ii) submission of information by the applicant on such substance would be duplicative of
information which has been submitted to the
Administrator in accordance with such subsection,
the Administrator shall exempt the applicant
from the requirement to submit such information on such substance. No exemption which is
granted under this subparagraph with respect to
the submission of information for a chemical
substance may take effect before the beginning
of the reimbursement period applicable to such
information.

§ 2604

TITLE 15—COMMERCE AND TRADE

(B) If the Administrator exempts any person,
under subparagraph (A), from submitting information required under subsection (b)(2) for a
chemical substance because of the existence of
previously submitted information and if such
exemption is granted during the reimbursement
period for such information, then (unless such
person and the persons referred to in clauses (i)
and (ii) agree on the amount and method of reimbursement) the Administrator shall order the
person granted the exemption to provide fair
and equitable reimbursement (in an amount determined under rules of the Administrator)—
(i) to the person who previously submitted
the information on which the exemption was
based, for a portion of the costs incurred by
such person in complying with the requirement under subsection (b)(2) to submit such
information, and
(ii) to any other person who has been required under this subparagraph to contribute
with respect to such costs, for a portion of the
amount such person was required to contribute.
In promulgating rules for the determination of
fair and equitable reimbursement to the persons
described in clauses (i) and (ii) for costs incurred
with respect to a chemical substance, the Administrator shall, after consultation with the
Attorney General and the Federal Trade Commission, consider all relevant factors, including
the effect on the competitive position of the person required to provide reimbursement in relation to the persons to be reimbursed and the
share of the market for such substance of the
person required to provide reimbursement in relation to the share of such market of the persons
to be reimbursed. For purposes of judicial review, an order under this subparagraph shall be
considered final agency action.
(C) For purposes of this paragraph, the reimbursement period for any previously submitted
information for a chemical substance is a period—
(i) beginning on the date of the termination
of the prohibition, imposed under this section,
on the manufacture or processing of such substance by the person who submitted such information to the Administrator, and
(ii) ending—
(I) five years after the date referred to in
clause (i), or
(II) at the expiration of a period which begins on the date referred to in clause (i) and
is equal to the period which the Administrator determines was necessary to develop
such information,
whichever is later.
(3) The requirements of subsections (a) and (b)
do not apply with respect to the manufacturing
or processing of any chemical substance which
is manufactured or processed, or proposed to be
manufactured or processed, only in small quantities (as defined by the Administrator by rule)
solely for purposes of—
(A) scientific experimentation or analysis,
or
(B) chemical research on, or analysis of such
substance or another substance, including
such research or analysis for the development
of a product,

Page 1712

if all persons engaged in such experimentation,
research, or analysis for a manufacturer or processor are notified (in such form and manner as
the Administrator may prescribe) of any risk to
health which the manufacturer, processor, or
the Administrator has reason to believe may be
associated with such chemical substance.
(4) The Administrator may, upon application
and by rule, exempt the manufacturer of any
new chemical substance from all or part of the
requirements of this section if the Administrator determines that the manufacture, processing, distribution in commerce, use, or disposal of such chemical substance, or that any
combination of such activities, will not present
an unreasonable risk of injury to health or the
environment, including an unreasonable risk to
a potentially exposed or susceptible subpopulation identified by the Administrator under
the conditions of use.
(5) The Administrator may, upon application,
make the requirements of subsections (a) and (b)
inapplicable with respect to the manufacturing
or processing of any chemical substance (A)
which exists temporarily as a result of a chemical reaction in the manufacturing or processing
of a mixture or another chemical substance, and
(B) to which there is no, and will not be, human
or environmental exposure.
(6) Immediately upon receipt of an application
under paragraph (1) or (5) the Administrator
shall publish in the Federal Register notice of
the receipt of such application. The Administrator shall give interested persons an opportunity to comment upon any such application
and shall, within 45 days of its receipt, either approve or deny the application. The Administrator shall publish in the Federal Register notice of the approval or denial of such an application.
(i) Definitions
(1) For purposes of this section, the terms
‘‘manufacture’’ and ‘‘process’’ mean manufacturing or processing for commercial purposes.
(2) For purposes of this chapter, the term ‘‘requirement’’ as used in this section shall not displace any statutory or common law.
(3) For purposes of this section, the term ‘‘applicable review period’’ means the period starting on the date the Administrator receives a notice under subsection (a)(1) and ending 90 days
after that date, or on such date as is provided
for in subsection (b)(1) or (c).
(Pub. L. 94–469, title I, § 5, Oct. 11, 1976, 90 Stat.
2012; renumbered title I, Pub. L. 99–519, § 3(c)(1),
Oct. 22, 1986, 100 Stat. 2989; amended Pub. L.
114–182, title I, §§ 5, 19(e), June 22, 2016, 130 Stat.
454, 506.)
AMENDMENTS
2016—Subsec. (a)(1). Pub. L. 114–182, § 5(1)(A), designated existing provisions as subpar. (A) and redesignated former subpars. (A) and (B) as cls. (i) and (ii), respectively; substituted ‘‘Except as provided in subparagraph (B) of this paragraph and’’ for ‘‘Except as provided in’’ in introductory provisions; substituted ‘‘significant new use.’’ for ‘‘significant new use,’’ at end of
cl. (ii); struck out concluding provisions ‘‘unless such
person submits to the Administrator, at least 90 days
before such manufacture or processing, a notice, in accordance with subsection (d), of such person’s intention

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TITLE 15—COMMERCE AND TRADE

to manufacture or process such substance and such person complies with any applicable requirement of subsection (b).’’; and added subpar. (B).
Subsec. (a)(3) to (5). Pub. L. 114–182, § 5(1)(B), added
pars. (3) to (5).
Subsec. (b). Pub. L. 114–182, § 5(2)(A), substituted ‘‘information’’ for ‘‘test data’’ in heading.
Subsec. (b)(1)(A). Pub. L. 114–182, § 19(e)(1)(A), substituted ‘‘a rule, order, or consent agreement’’ for ‘‘a
rule promulgated’’ and ‘‘such rule, order, or consent
agreement’’ for ‘‘such rule’’.
Pub. L. 114–182, § 5(2)(B)(i), substituted ‘‘submit information’’ for ‘‘submit test data’’ and ‘‘such information’’ for ‘‘such data’’.
Subsec. (b)(1)(B). Pub. L. 114–182, § 5(2)(B)(ii), in concluding provisions, substituted ‘‘information’’ for ‘‘test
data’’,
‘‘subsection
(a)(1)(A)(i)’’
for
‘‘subsection
(a)(1)(A)’’, and ‘‘subsection (a)(1)(A)(ii)’’ for ‘‘subsection
(a)(1)(B)’’.
Subsec. (b)(1)(B)(ii). Pub. L. 114–182, § 19(e)(1)(B), substituted ‘‘rule or order’’ for ‘‘rule promulgated’’.
Subsec. (b)(2)(A). Pub. L. 114–182, § 5(2)(C)(i)(II), (III),
in concluding provisions, substituted ‘‘may’’ for
‘‘shall’’ and ‘‘information prescribed’’ for ‘‘data prescribed’’.
Subsec. (b)(2)(A)(ii). Pub. L. 114–182, § 19(e)(1)(C), substituted ‘‘rule, order, or consent agreement’’ for ‘‘rule
promulgated’’.
Pub. L. 114–182, § 5(2)(C)(i)(I), substituted ‘‘information’’ for ‘‘test data’’.
Subsec. (b)(2)(B). Pub. L. 114–182, § 5(2)(C)(ii)(I)–(III),
in introductory provisions, substituted ‘‘Information’’
for ‘‘Data’’, ‘‘be information’’ for ‘‘be data’’, ‘‘the information’’ for ‘‘the data’’, and ‘‘shows’’ for ‘‘show’’.
Subsec. (b)(2)(B)(i). Pub. L. 114–182, § 5(2)(C)(ii)(IV),
substituted ‘‘subsection (a)(1)(A)(i)’’ for ‘‘subsection
(a)(1)(A)’’.
Subsec. (b)(2)(B)(ii). Pub. L. 114–182, § 5(2)(C)(ii)(V),
substituted ‘‘subsection (a)(1)(A)(ii)’’ for ‘‘subsection
(a)(1)(B)’’.
Subsec. (b)(3). Pub. L. 114–182, § 5(2)(D), substituted
‘‘Information’’ for ‘‘Data’’ and ‘‘paragraph (1) or (2) of
this subsection or under subsection (e)’’ for ‘‘paragraph
(1) or (2)’’.
Subsec. (b)(4)(A)(i). Pub. L. 114–182, § 5(2)(E)(i), inserted ‘‘, without consideration of costs or other
nonrisk factors’’ after ‘‘health or the environment’’.
Subsec. (b)(4)(C). Pub. L. 114–182, § 5(2)(E)(ii), struck
out ‘‘, except that (i) the Administrator shall give interested persons an opportunity for the oral presentation of data, views, or arguments, in addition to an
opportunity to make written submissions, (ii) a transcript shall be kept of any oral presentation, and (iii)
the Administrator shall make and publish with the rule
the finding described in subparagraph (A)’’ before period at end.
Subsec. (c). Pub. L. 114–182, § 5(3), substituted ‘‘review’’ for ‘‘notice’’ in heading and struck out ‘‘before
which the manufacturing or processing of a chemical
substance subject to such subsection may begin’’ after
‘‘subsection (a) or (b)’’ in text.
Subsec. (d)(1)(B). Pub. L. 114–182, § 5(4)(A), substituted
‘‘information’’ for ‘‘test data’’.
Subsec. (d)(1)(C). Pub. L. 114–182, § 5(4)(B), substituted
‘‘information’’ for ‘‘data’’.
Subsec. (d)(2). Pub. L. 114–182, § 5(4)(B), substituted
‘‘information’’ for ‘‘data’’ wherever appearing.
Subsec. (d)(2)(B). Pub. L. 114–182, § 5(4)(C), substituted
‘‘uses of such substance identified in the notice’’ for
‘‘uses or intended uses of such substance’’.
Subsec. (d)(2)(C). Pub. L. 114–182, § 19(e)(2), substituted
‘‘rule, order, or consent agreement’’ for ‘‘rule’’.
Subsec. (d)(3). Pub. L. 114–182, § 5(4)(D), substituted
‘‘for which the applicable review period’’ for ‘‘for which
the notification period prescribed by subsection (a), (b),
or (c)’’ and ‘‘such period’’ for ‘‘such notification period’’.
Subsec. (e)(1)(A). Pub. L. 114–182, § 5(5)(A)(iii)(III), inserted before period at end of concluding provisions ‘‘to
the extent necessary to protect against an unreason-

§ 2604

able risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed
or susceptible subpopulation identified as relevant by
the Administrator under the conditions of use, and the
submitter of the notice may commence manufacture of
the chemical substance, or manufacture or processing
of the chemical substance for a significant new use, including while any required information is being developed, only in compliance with the order’’.
Pub. L. 114–182, § 5(5)(A)(iii)(II), which directed substitution of ‘‘applicable review period’’ for ‘‘notification
period applicable to the manufacturing or processing of
such substance under subsection (a), (b), (c)’’ in concluding provisions, was executed by making the substitution for ‘‘notification period applicable to the manufacturing or processing of such substance under subsection (a), (b), or (c)’’ to reflect the probable intent of
Congress.
Pub. L. 114–182, § 5(5)(A)(iii)(I), substituted ‘‘shall
issue an order’’ for ‘‘may issue a proposed order’’ in
concluding provisions.
Subsec. (e)(1)(A)(i). Pub. L. 114–182, § 5(5)(A)(i), substituted ‘‘; or’’ for ‘‘; and’’ at end.
Subsec. (e)(1)(A)(ii)(I). Pub. L. 114–182, § 5(5)(A)(ii), inserted ‘‘without consideration of costs or other nonrisk
factors, including an unreasonable risk to a potentially
exposed subpopulation identified as relevant by the Administrator under the conditions of use;’’ after ‘‘health
or the environment,’’.
Subsec. (e)(1)(B). Pub. L. 114–182, § 5(5)(B)(iii), substituted ‘‘of the order’’ for ‘‘of the proposed order’’.
Pub. L. 114–182, § 5(5)(B)(ii), which directed substitution of ‘‘applicable review period’’ for ‘‘notification
period applicable to the manufacture or processing of
such substance under subsection (a), (b), (c)’’, was executed by making the substitution for ‘‘notification period applicable to the manufacture or processing of
such substance under subsection (a), (b), or (c)’’ to reflect the probable intent of Congress.
Pub. L. 114–182, § 5(5)(B)(i), substituted ‘‘An order’’ for
‘‘A proposed order’’.
Subsec. (e)(1)(C). Pub. L. 114–182, § 5(5)(C), struck out
subpar. (C) which read as follows: ‘‘If a manufacturer or
processor of a chemical substance to be subject to a
proposed order issued under subparagraph (A) files with
the Administrator (within the 30-day period beginning
on the date such manufacturer or processor received
the notice required by subparagraph (B)(ii)) objections
specifying with particularity the provisions of the
order deemed objectionable and stating the grounds
therefor, the proposed order shall not take effect.’’
Subsec. (e)(2). Pub. L. 114–182, § 5(5)(D), struck out
par. (2) which related to injunctions to prohibit or limit
the manufacture, processing, distribution in commerce,
use, or disposal of a chemical substance.
Subsec. (f)(1). Pub. L. 114–182, § 5(6)(A), substituted
‘‘determines that a chemical substance or significant
new use with’’ for ‘‘finds that there is a reasonable
basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical
substance with’’, ‘‘, without consideration of costs or
other nonrisk factors, including an unreasonable risk
to a potentially exposed subpopulation identified as
relevant by the Administrator under the conditions of
use,’’ for ‘‘before a rule promulgated under section 2605
of this title can protect against such risk,’’ and ‘‘applicable review period’’ for ‘‘notification period applicable
under subsection (a), (b), or (c) to the manufacturing or
processing of such substance’’ and struck out ‘‘, or that
any combination of such activities,’’ after ‘‘required by
subsection (a)’’ and ‘‘or will present’’ after ‘‘presents’’.
Subsec. (f)(2). Pub. L. 114–182, § 5(6)(B), substituted
‘‘Section 2605(d)(3)(B)’’ for ‘‘Section 2605(d)(2)(B)’’ in
concluding provisions.
Subsec. (f)(3)(A). Pub. L. 114–182, § 5(6)(C)(i), substituted ‘‘Administrator may’’ for ‘‘Administrator
may—’’, struck out cl. (i) designation before ‘‘issue’’,
substituted ‘‘an order to prohibit or limit the’’ for ‘‘a
proposed order to prohibit the’’ and ‘‘under paragraph

§ 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-

Page 1714

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.