Sec. 7. New chemicals and significant new uses
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Section 5 of the Toxic Substances Control Act ( 15 U.S.C. 2604 ) is amended— by striking the section designation and heading and inserting the following: ; by striking subsection (b); by redesignating subsection
(a)as subsection (b); by redesignating subsection
(i)as subsection
(a)and moving the subsection so as to appear at the beginning of the section; in subsection
(b)(as so redesignated)— in the subsection heading, by striking and inserting In general ; and Notices in paragraph (1), in the matter following subparagraph (B)— by striking subsection
(d)and inserting subsection
(b); and by striking and such person complies with any applicable requirement of subsection
(b); by redesignating subsections
(c)and
(d)as subsection
(d)and (c), respectively, and moving subsection
(c)(as so redesigned) so as appear after subsection
(b)(as redesignated by paragraph (3)); in subsection
(c)(as so redesignated)— by striking paragraph
(1)and inserting the following: The notice required by subsection
(a)shall include, with respect to a chemical substance— the information required by sections 720.45 and 720.50 of title 40, Code of Federal Regulations (or successor regulations); and information regarding conditions of use and reasonably anticipated exposures. ; in paragraph (2)— in the matter preceding subparagraph (A), by striking or of data under subsection
(b); in subparagraph (A), by adding and after the semicolon at the end; in subparagraph (B), by striking ; and and inserting a period; and by striking subparagraph (C); and in paragraph (3), by striking subsection
(a)and for which the notification period prescribed by subsection (a), (b), or
(c)and inserting subsection
(b)and for which the notification period prescribed by subsection
(b)or
(d); by striking subsection
(d)(as redesignated by paragraph (6)) and inserting the following: Subject to subparagraph (B), not later than 90 days after the date of receipt of a notice submitted under subsection (b), the Administrator shall— conduct an initial review of the notice; as needed, develop a profile of the relevant chemical substance and the potential for exposure to humans and the environment; and make any necessary determination under paragraph (3). Except as provided in paragraph (5), the Administrator may extend the period described in subparagraph
(A)for good cause for 1 or more periods, the total of which shall be not more than 90 days. In evaluating a notice under paragraph (1), the Administrator shall take into consideration— any relevant information identified in subsection (c)(1); and any other relevant additional information available to the Administrator. Before the end of the applicable period for review under paragraph (1), based on the information described in paragraph (2), and subject to section 18(g), the Administrator shall determine that— the relevant chemical substance or significant new use is not likely to meet the safety standard, in which case the Administrator shall take appropriate action under paragraph (4); the relevant chemical substance or significant new use is likely to meet the safety standard, in which case the Administrator shall allow the review period to expire without additional restrictions; or additional information is necessary in order to make a determination under subparagraph
(A)or (B), in which case the Administrator shall take appropriate action under paragraph (5). If the Administrator makes a determination under subparagraph
(A)or
(C)of paragraph
(3)with respect to a notice submitted under subsection (b)— the Administrator, before the end of the applicable period for review under paragraph
(1)and by consent agreement or order, as appropriate, shall prohibit or otherwise restrict the manufacture, processing, use, distribution in commerce, or disposal (as applicable) of the chemical substance, or of the chemical substance for a significant new use, without compliance with the restrictions specified in the consent agreement or order that the Administrator determines are sufficient to ensure that the chemical substance or significant new use is likely to meet the safety standard; and no person may commence manufacture of the chemical substance, or manufacture or processing of the chemical substance for a significant new use, except in compliance with the restrictions specified in the consent agreement or order. If the Administrator makes a determination under subparagraph
(B)of paragraph
(3)with respect to a chemical substance or significant new use for which a notice was submitted under subsection (b), at the end of the applicable period for review under paragraph (1), the submitter of the notice may commence manufacture for commercial purposes of the chemical substance or manufacture or processing of the chemical substance for a significant new use. Not later than 90 days after issuing a consent agreement or order under subparagraph (A), the Administrator shall— take into consideration whether to promulgate a rule pursuant to subsection (b)(2) that identifies as a significant new use any manufacturing, processing, use, distribution in commerce, or disposal of the chemical substance, or of the chemical substance for a new use, that is not in compliance with the restrictions imposed by the consent agreement or order; and initiate a rulemaking described in clause (i); or publish a statement describing the reasons of the Administrator for not initiating a rulemaking. A prohibition or other restriction under subparagraph
(A)may include, as appropriate— subject to section 18(g), a requirement that a chemical substance shall be marked with, or accompanied by, clear and adequate minimum warnings and instructions with respect to use, distribution in commerce, or disposal, or any combination of those activities, with the form and content of the minimum warnings and instructions to be prescribed by the Administrator; a requirement that manufacturers or processors of the chemical substance shall— make and retain records of the processes used to manufacture or process, as applicable, the chemical substance; or monitor or conduct such additional tests as are reasonably necessary to address potential risks from the manufacture, processing, distribution in commerce, use, or disposal, as applicable, of the chemical substance, subject to section 4; a restriction on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce— in general; or for a particular use; a prohibition or other restriction of— the manufacture, processing, or distribution in commerce of the chemical substance for a significant new use; any method of commercial use of the chemical substance; or any method of disposal of the chemical substance; or a prohibition or other restriction on the manufacture, processing, or distribution in commerce of the chemical substance— in general; or for a particular use. The Administrator shall consult with the Assistant Secretary of Labor for Occupational Safety and Health prior to adopting any prohibition or other restriction under this subsection to address workplace exposures. For purposes of this Act, the term requirement as used in this section does not displace common law. If the Administrator determines under paragraph (3)(C) that additional information is necessary to conduct a review under this subsection, the Administrator— shall provide an opportunity for the submitter of the notice to submit the additional information; may, by agreement with the submitter, extend the review period for a reasonable time to allow the development and submission of the additional information; may promulgate a rule, enter into a testing consent agreement, or issue an order under section 4 to require the development of the information; and on receipt of information the Administrator finds supports the determination under paragraph (3), shall promptly make the determination. ; by striking subsections
(e)through
(g)and inserting the following: Not later than 30 days after the date on which a manufacturer that has submitted a notice under subsection
(b)commences nonexempt commercial manufacture of a chemical substance, the manufacturer shall submit to the Administrator a notice of commencement that identifies— the name of the manufacturer; and the initial date of nonexempt commercial manufacture. A manufacturer or processor that has submitted a notice under subsection (b), but that has not commenced nonexempt commercial manufacture or processing of the chemical substance, may withdraw the notice. The Administrator may review a chemical substance under section 4A at any time after the Administrator receives— a notice of commencement for a chemical substance under subsection (c); or new information regarding the chemical substance. Subject to section 14, the Administrator shall make available to the public— all notices, determinations, consent agreements, rules, and orders of the Administrator; and all information submitted or issued under this section. ; and in subsection (h)— in paragraph (1), in the matter preceding subparagraph (A), by striking
(a)or ; by striking paragraph (2); by redesignating paragraphs
(3)through
(6)as paragraphs
(2)through (5), respectively; in paragraph
(2)(as so redesignated), in the matter preceding subparagraph (A), by striking subsections
(a)and
(b)and inserting subsection
(b); in paragraph
(3)(as so redesignated)— in the first sentence, by striking will not present an unreasonable risk of injury to health or the environment and inserting will meet the safety standard ; and by striking the second sentence; in paragraph
(4)(as so redesignated), by striking subsections
(a)and
(b)and inserting subsection
(b); and in paragraph
(5)(as so redesignated), in the first sentence, by striking paragraph
(1)or
(5)and inserting paragraph
(1)or
(4).
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Sec. 7
New chemicals and significant new uses
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