Sec. 5. New chemicals and significant new uses
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/bill/113/s/1009/is/section-5A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 5 ( 15 U.S.C. 2604 ) is amended— by striking the section designation and heading and inserting the following: ; in subsection (a)(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 striking subsection (b); by redesignating subsection
(d)as subsection
(b)and moving the subsection so as to appear after subsection (a); in subsection
(b)(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 intended conditions of use and reasonably anticipated exposure. ; 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 , (b), ; by striking subsection
(c)and inserting the following: Subject to subparagraph (B), not later than 90 days after the date of receipt of a notice submitted under subsection (a), 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 (4). Except as provided in paragraph (6), the Administrator may extend the period described in subparagraph
(A)for good cause for one or more periods, the total of which shall be not more than 90 days. Unless the Administrator determines under paragraph (4)(A) that a chemical substance is not likely to meet the safety standard, at the end of the applicable period for review under paragraph (1), a chemical substance may be the subject of a notice of commencement under subsection (d). In evaluating a notice under paragraph (1), the Administrator shall take into consideration— the information identified in section 4(c); and any additional information provided by the submitter. Before the end of the applicable period for review under paragraph (1), based on the information described in paragraph (3), the Administrator shall determine that— the relevant chemical substance is not likely to meet the safety standard under the intended conditions of use, in which case the Administrator shall take appropriate action under paragraph (5); the relevant chemical substance is likely to meet the safety standard under the intended conditions of use, 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 (6). If the Administrator makes a determination under paragraph (4)(A) with respect to a notice, before the end of the applicable period for review under paragraph (1), the Administrator shall, by consent agreement or order, as appropriate— prohibit manufacture of the chemical substance, or prohibit such manufacture without compliance with restrictions specified in a relevant consent agreement or order; or prohibit manufacture or processing of the chemical substance for a significant new use, or prohibit such manufacture or processing without compliance with restrictions specified in a relevant consent agreement or order. A prohibition or limitation under subparagraph
(A)may include, as appropriate— a requirement that a chemical substance be marked with, or accompanied by, clear and adequate 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 warnings and instructions to be prescribed by the Administrator; a requirement that manufacturers or processors, as applicable, of the chemical substance make and retain records of the processes used to manufacture or process the chemical substance; a requirement that manufacturers or processors, as applicable, monitor or conduct such additional tests as are reasonably necessary to ensure compliance with this Act, subject to section 4(g); a limitation on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce; a limitation on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce for a particular use; a prohibition or other regulation of the manufacture, processing, or distribution in commerce of the chemical substance for a significant new use; a prohibition or other regulation of any method of commercial use of the chemical substance; a prohibition or other regulation of any method of disposal of the chemical substance; a prohibition on the manufacture, processing, or distribution in commerce of the chemical substance; a prohibition on the manufacture, processing, or distribution in commerce of the chemical substance for a particular use; or such other requirements as the Administrator determines to be necessary. If the Administrator determines under paragraph (4)(C) that additional data and information (including, for example, information on exposure or exposure potential) are needed in order to conduct a review under this subsection, the Administrator— shall provide an opportunity for the submitter of the notice to submit such 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; on receipt of the information, shall promptly make a determination under paragraph (4); and may take action under paragraph
(5)pending receipt of the additional data and information, which may, as appropriate, permit the submitter of the notice to file a notice of commencement under subsection (d). ; by striking subsections
(e)through
(g)and inserting the following: Not later than 30 days after the date on which a manufacturer or processor that has submitted a notice under subsection
(a)commences nonexempt commercial manufacture of a chemical substance or nonexempt commercial manufacture or processing of a chemical substance for a significant new use, as applicable, the manufacturer or processor shall submit to the Administrator a notice of commencement that identifies— the name of the manufacturer or processor; and the initial date of nonexempt commercial manufacture or nonexempt commercial manufacture or processing for a significant new use. A manufacturer or processor that has submitted a notice under subsection (a), 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 4(e) at any time after the Administrator receives— a notice of commencement for a chemical substance under subsection (d); or significant new information regarding the chemical substance. Subject to section 14, the Administrator shall make available to the public all notices, rules and orders of the Administrator, and all data and information submitted or issued under this section. ; by redesignating subsections
(h)and
(i)as subsections
(g)and (h), respectively; and in subsection
(g)(as so redesignated)— in paragraph (1), in the matter preceding subparagraph (A), by striking or
(b); by striking paragraph (2); by redesignating paragraphs
(3)through
(6)as paragraphs
(2)through (5), respectively; in paragraph
(2)(as so redesignated), by striking subsections
(a)and
(b)and inserting subsection
(a); 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 is expected to meet the safety standard under the intended conditions of use ; in paragraph
(4)(as so redesignated), by striking subsections
(a)and
(b)and inserting subsection
(a); 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. 5
New chemicals and significant new uses
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