(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.
(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)
(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,
(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,
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.
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 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 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 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 (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 identified 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.