Sec. 5. MANUFACTURING AND PROCESSING NOTICES
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## SEC. 5 MANUFACTURING AND PROCESSING NOTICES Section 5 of the Toxic Substances Control Act (15 U.S.C. 2604) is amended— ####
(1)in subsection (a)— #####
(A)in paragraph (1)— ######
(i)by striking “Except as provided in” and inserting “(A) Except as provided in subparagraph
(B)of this paragraph and”; ######
(ii)by redesignating subparagraphs
(A)and
(B)as clauses
(i)and (ii), respectively; ######
(iii)by striking all that follows “significant new use” and inserting a period; and ######
(iv)by adding at the end the following: > > ##### “(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.” > ; and #####
(B)by adding at the end the following new paragraphs: > > #### “(3) Review and determination > > Within the applicable review period, subject to section 18, 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 > > > ###### “(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 26(b), 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.” > ; ####
(2)in subsection (b)— #####
(A)in the subsection heading, by striking “Test Data” and inserting “Information”; #####
(B)in paragraph (1)— ######
(i)in subparagraph (A)— ######
(I)by striking “test data” and inserting “information”; and ######
(II)by striking “such data” and inserting “such information”; and ######
(ii)in subparagraph (B)— ######
(I)by striking “test data” and inserting “information”; ######
(II)by striking “subsection (a)(1)(A)” and inserting “subsection (a)(1)(A)(i)”; and ######
(III)by striking “subsection (a)(1)(B)” and inserting “subsection (a)(1)(A)(ii)”; #####
(C)in paragraph (2)— ######
(i)in subparagraph (A)— ######
(I)by striking “test data” in clause
(ii)and inserting “information”; ######
(II)by striking “shall” and inserting “may”; and ######
(III)by striking “data prescribed” and inserting “information prescribed”; and ######
(ii)in subparagraph (B)— ######
(I)by striking “Data” and inserting “Information”; ######
(II)by striking “data” both places it appears and inserting “information”; ######
(III)by striking “show” and inserting “shows”; ######
(IV)by striking “subsection (a)(1)(A)” in clause
(i)and inserting “subsection (a)(1)(A)(i)”; and ######
(V)by striking “subsection (a)(1)(B)” in clause
(ii)and inserting “subsection (a)(1)(A)(ii)”; #####
(D)in paragraph (3)— ######
(i)by striking “Data” and inserting “Information”; and ######
(ii)by striking “paragraph
(1)or (2)” and inserting “paragraph
(1)or
(2)of this subsection or under subsection (e)”; and #####
(E)in paragraph (4)— ######
(i)in subparagraph (A)(i), by inserting “, without consideration of costs or other nonrisk factors” after “health or the environment”; and ######
(ii)in subparagraph (C), by striking “, except that” and all that follows through “subparagraph (A)”; ####
(3)in subsection (c)— #####
(A)in the subsection heading, by striking “Notice” and inserting “Review”; and #####
(B)by striking “before which” and all that follows through “subsection may begin”; ####
(4)in subsection (d)— #####
(A)by striking “test data” in paragraph (1)(B) and inserting “information”; #####
(B)by striking “data” each place it appears in paragraph (1)(C) and paragraph
(2)and inserting “information”; #####
(C)in paragraph (2)(B), by striking “uses or intended uses of such substance” and inserting “uses of such substance identified in the notice”; and #####
(D)in paragraph (3)— ######
(i)by striking “for which the notification period prescribed by subsection (a), (b), or (c)” and inserting “for which the applicable review period”; and ######
(ii)by striking “such notification period” and inserting “such period”; ####
(5)in subsection (e)— #####
(A)in paragraph (1)(A)— ######
(i)in clause (i), by striking “; and” and inserting “; or”; ######
(ii)in clause (ii)(I), by inserting “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,”; and ######
(iii)in the matter after clause (ii)(II)— ######
(I)by striking “may issue a proposed order” and inserting “shall issue an order”; ######
(II)by striking “notification period applicable to the manufacturing or processing of such substance under subsection (a), (b), (c)” and inserting “applicable review period”; and ######
(III)by inserting “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” before the period at the end; #####
(B)in paragraph (1)(B)— ######
(i)by striking “A proposed order” and inserting “An order”; ######
(ii)by striking “notification period applicable to the manufacture or processing of such substance under subsection (a), (b), (c)” and inserting “applicable review period”; and ######
(iii)by striking “of the proposed order” and inserting “of the order”; #####
(C)by striking paragraph (1)(C); and #####
(D)by striking paragraph (2); ####
(6)in subsection (f)— #####
(A)in paragraph (1)— ######
(i)by striking “finds that there is a reasonable basis to conclude that the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance with” and inserting “determines that a chemical substance or significant new use with”; ######
(ii)by striking “, or that any combination of such activities,”; ######
(iii)by striking “or will present”; ######
(iv)by striking “before a rule promulgated under section 6 can protect against such risk,” and inserting “, 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,”; and ######
(v)by striking “notification period applicable under subsection (a), (b), or
(c)to the manufacturing or processing of such substance” and inserting “applicable review period”; #####
(B)in paragraph (2), the matter following subparagraph (C), by striking “Section 6(d)(2)(B)” and inserting “Section 6(d)(3)(B)”; #####
(C)in paragraph (3)— ######
(i)in subparagraph (A)— ######
(I)by striking “Administrator may” and all that follows through “issue a proposed order to prohibit the” and inserting “Administrator may issue an order to prohibit or limit the”; and ######
(II)by striking “under paragraph (1)” and all that follows through “processing of such substance.” and inserting “under paragraph (1). Such order shall take effect on the expiration of the applicable review period.”; ######
(ii)by striking subparagraph
(B)and redesignating subparagraph
(C)as subparagraph (B); ######
(iii)in subparagraph (B), as so redesignated— ######
(I)by striking “subparagraphs
(B)and (C)” and inserting “subparagraph (B)”; ######
(II)by striking “clause
(i)of”; and ######
(III)by striking “; and the provisions of subparagraph
(C)of subsection (e)(2) shall apply with respect to an injunction issued under subparagraph (B)”; and ######
(iv)by striking subparagraph (D); and #####
(D)by adding at the end the following: > > #### “(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 Occupational 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.” > ; ####
(7)by amending subsection
(g)to read as follows: > > ### “(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.” > ; ####
(8)in subsection (h)— #####
(A)in paragraph (1)(A), by inserting “, 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”; #####
(B)in paragraph (2), by striking “data” each place it appears and inserting “information”; and #####
(C)in paragraph (4), by striking “. A rule promulgated” and all that follows through “section 6(c)” and inserting “, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified by the Administrator under the conditions of use”; and ####
(9)by amending subsection
(i)to read as follows: > > ### “(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 Act, 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).” > .
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Sec. 5
MANUFACTURING AND PROCESSING NOTICES
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