Sec. 6. New chemical substances and new uses of chemical substances
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Section 5 of the Toxic Substances Control Act ( 15 U.S.C. 2604 ) is amended to read as follows: In this section: The terms manufacture and process mean manufacture or process, respectively, for commercial purposes. The term test marketing does not include any provision of a chemical substance or mixture, or an article containing a chemical substance or mixture, to an end consumer of the chemical substance, mixture, or article. Except as provided in subsection (h), no person may manufacture a new chemical substance, or process the chemical substance for a use that is proposed to meet the criteria described in section 6(h)(2)(B), unless— the person submits to the Administrator a notice, in accordance with subsection (g)(1)(A), of the intention of the person to manufacture or process the substance; the person complies with subsection (f); and the Administrator finds that— the new chemical substance is likely to meet the safety standard under section 6(d), which shall be limited to substances assigned by the Administrator to 1 of the categories described in paragraph (2)(D)(iii); or the person has established by clear and convincing evidence that 1 or more uses of the new chemical substance meet the criteria described in section 6(h)(2)(B), in which case— the Administrator may by order allow the person to manufacture or process the substance only for such use or uses in accordance with subparagraph
(A)of section 6(h)(2); the procedures and requirements specified in subparagraphs (A), (C), (D), and
(E)of section 6(h)(2) shall apply; and the Administrator shall not, upon receipt of a notice of commencement for the chemical substance under subsection (d), add the chemical substance to the active inventory established under section 8(h)(1). Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall promulgate a rule that— designates the categories in accordance with subparagraph
(D)and specifies the process and criteria the Administrator will use to categorize new chemical substances; and describes criteria and factors the Administrator will use to assess weight of evidence and the quality and reliability of information used to inform categorization decisions. In categorizing a new chemical substance, the Administrator shall consider information on the substance available to the Administrator at the time the categorization decision is to be made, including information— received by the Administrator from the manufacturer or processor of the substance in accordance with subsection (f); submitted to a governmental body in another jurisdiction, to the extent that the information is accessible to the Administrator; derived through application of validated structure-activity relationship or other models developed by the Administrator to estimate the environmental and human health effects, environmental and biological fate and behavior, and exposure potential of chemical substances; inferred based on the degree of similarity of the structure or properties of the new chemical substance to those of 1 or more other chemical substances for which reliable information exists that is relevant to predicting the potential environmental or human health effects, environmental or biological fate and behavior, or exposure potential of the new chemical substance; and any additional information the Administrator determines is needed to categorize the substance, including information identified as needed based on the analysis by the Administrator of estimated or inferred information described in clauses
(iii)and (iv). Not later than 90 days after the date of receipt of a notice under paragraph (1)(A), the Administrator shall assign the new chemical substance for which the notice was submitted to 1 of the categories described in subparagraph (D). The rule promulgated pursuant to subparagraph
(A)shall incorporate, establish criteria for, and further specify as needed, the categories described in this subparagraph, to 1 of which each new chemical substance for which a notice is submitted pursuant to paragraph
(1)shall be assigned. The Administrator shall designate as a substance of very high concern any new chemical substance that— is toxic, persists in the environment, and is bioaccumulative; or is highly hazardous. The Administrator shall allow the submitter of a notice under paragraph (1)(A) for a new chemical substance assigned to the category described in this clause to manufacture or process the new chemical substance only in accordance with paragraph (1)(C)(ii). No other person may manufacture or process the chemical substance unless the person has submitted a notice pursuant to paragraph
(1)and the requirements of paragraph (1)(C)(ii) have been met with respect to that notice. The Administrator shall designate as a substance likely to meet the safety standard any new chemical substance that the Administrator determines, based on available information, would likely meet the safety standard under section 6(d)— for uses and under conditions specified by the submitter of the notice for the new chemical substance pursuant to paragraph (1); or for uses and under additional conditions that could be specified by the Administrator in making a safety standard determination for the substance. The Administrator shall assign to the category described in item
(aa)any new chemical substance that meets the criteria specified in subclause
(II)or (III). Within the category described in subclause (I), the Administrator shall designate as a substance of very low concern any new chemical substance that, based on robust information, the Administrator determines possesses intrinsic low-hazard properties so that no further action by the Administrator is warranted unless and until the Administrator receives new information that warrants a different categorization of the chemical substance. In identifying new chemical substances to be placed in the category described in this subclause, the Administrator shall base the designation of a new chemical substance as a substance of very low concern on the applicable minimum information set required under section 4, unless the Administrator determines that such designation of a particular new chemical substance— can be made to a high degree of confidence based on less information; or requires information in addition to the full minimum information set to address conflicting or ambiguous findings, in which case the Administrator may require the development and submission of the additional information. Within the category described in subclause (I), the Administrator shall designate as a substance to undergo a safety standard determination any new chemical substance that the Administrator determines, based on a screening of available use, hazard, and exposure information, has information available for the chemical substance that is sufficiently robust to determine that the chemical substance does not meet the criteria for the categories described in subclause
(II)or clause
(ii)or (iv). For a new chemical substance designated as likely to meet the safety standard pursuant to subclause
(II)or (III), the Administrator shall, upon submission of a notice of commencement described in subsection (d)— add the chemical substance to the active inventory described in section 8(h)(1); and for a chemical substance designated to undergo a safety standard determination, at the discretion of the Administrator accounting for timing of the submission and workload considerations, add the chemical substance to the current batch or hold the substance until the next batch of substances to be prioritized in accordance with section 6(b)(4). Pending the completion of a safety standard determination under section 6(d), a chemical substance designated as a substance likely to meet the safety standard may be manufactured or processed for uses and under conditions specified by the Administrator in determining that the chemical substance is likely to meet the safety standard— by the submitter of the notice for the chemical substance submitted pursuant to paragraph (1)(A), upon submission of a notice for the chemical substance pursuant to subsection (d); by other manufacturers of the chemical substance, once the chemical substance has been placed on the active inventory described in section 8(h)(1), upon submission of a declaration for the chemical substance pursuant to section 8(b)(1)(B); or by processors of the substance, upon compliance with the requirements of section 8(e). The Administrator shall designate as a substance with insufficient information any new chemical substance for which the Administrator concludes, after gathering and screening available use, hazard, and exposure information, that needed information for the chemical substance is not available, is insufficient, or is not of sufficient quality and reliability to allow for an informed categorization decision. For substances designated under this clause, the Administrator shall require submission of the applicable minimum information set specified under section 4 as needed to inform categorization decisionmaking for new chemical substances. Following submission of the applicable minimum information set for the chemical substance pursuant to subclause (II), the Administrator shall recategorize the chemical substance using the categories and process described in this paragraph. Notwithstanding paragraph (1)(C)(ii), no person may manufacture or process a chemical substance designated under this clause until and unless the information described in subclause
(II)has been submitted and the Administrator has recategorized the substance, at which time the provisions applicable to the category to which the substance has been assigned shall apply. The Administrator shall designate as a substance unlikely to meet the safety standard any new chemical substance that the Administrator determines, based on available information, would be unlikely to meet the safety standard under section 6(d)— for uses and under conditions specified by the submitter of the notice for the chemical substance pursuant to paragraph (1); or for other uses or under additional conditions that the Administrator may evaluate in making a safety standard determination for the chemical substance. Except as provided under clause (ii), no person may manufacture or process a chemical substance designated under this clause. Except as provided in subparagraph (B), with respect to an existing chemical substance for which the Administrator has not made a safety standard determination under section 6(d), no person may manufacture or process the chemical substance— for a use that was not ongoing on the date of enactment of the Safe Chemicals Act of 2013 ; or at a volume that is significantly increased from the volume as of the date of enactment of the Safe Chemicals Act of 2013 . A person may manufacture or process a chemical substance in a manner prohibited by subparagraph
(A)if— the person submits to the Administrator the notice specified in subsection (g)(1)(B); the person complies with subsection (f); and such manufacturing or processing is consistent with subsection (b)(2)(D)(iii)(V). Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall issue guidance for the purpose of identifying what constitute new uses and significantly increased production volumes under this paragraph. For an existing chemical substance for which the Administrator has determined under section 6(d) that the manufacturers and processors of the chemical substance have established that the substance meets the applicable safety standard, no person may manufacture, process, distribute in commerce, use, or dispose of the chemical substance, or a mixture or article containing the chemical substance for uses, at production volumes, or in manners other than those the Administrator specified in the safety standard determination, unless— the person submits to the Administrator a notice in accordance with subsection (g)(1)(C) of the intention of the person to manufacture, process, distribute in commerce, use, or dispose of the chemical substance, or a mixture or article containing the chemical substance, for the new use or at a new production volume, or in such other manner that is inconsistent with a specified condition or term in the safety standard determination made by the Administrator for that substance; and the Administrator determines that the person submitting the notice has established that the chemical substance will continue to meet the safety standard if the allowed uses, production volumes, or other specified conditions or terms for that substance, are revised to encompass the new use, new production volume, or other manner of manufacturing, processing, distribution in commerce, use, or disposal. If the conditions described in clauses
(i)and
(ii)of subparagraph
(A)are satisfied, the Administrator shall, by order, amend the safety standard determination for the chemical substance to include the new use, production volume, or other manner of manufacturing or processing among the allowed uses, production volumes, or manners of manufacturing, processing, distribution in commerce, use, or disposal of the chemical substance. Except as provided in clauses
(ii)and (iii), not later than 180 days after the date of receipt of a notice pursuant to subparagraph (A)(i), the Administrator shall determine whether the person submitting the notice has established that the chemical substance will continue to meet the safety standard under section 6(d). The Administrator may extend the determination deadline under clause
(i)by 1 or more additional periods not to exceed 1 year in the aggregate, in such manner as the Administrator determines necessary. The failure of the Administrator to make a timely determination in accordance with this paragraph shall not be sufficient to satisfy subparagraph (A)(ii). Not later than 30 days after the date on which a manufacturer or processor commences manufacturing or processing of a new chemical substance, the manufacturer or processor shall submit to the Administrator a notice of commencement of manufacture or processing. The notice of commencement shall— be considered equivalent to the declaration required under subparagraph
(A)or
(C)of section 8(b)(2); and include the information described in section 8(b)(5). A person who has submitted a notice for a chemical substance under subsection
(b)or (c), and has not commenced with manufacture or processing of the substance, may withdraw the notice. The Administrator shall determine by order or rule that a variant of a chemical substance exhibiting 1 or more special substance characteristics— is a use that is separate from any use of the chemical substance that does not exhibit the special substance characteristics; or is a distinct chemical substance. In the case of a chemical substance that the Administrator determines to be a separate use based on the special substance characteristics of the chemical substance, the manufacturer or processor shall satisfy such further conditions as the Administrator establishes, by order or rule. In the case of a chemical substance that the Administrator determines to be a distinct chemical substance based on the special substance characteristics of the chemical substance, and that is not listed on the active inventory established under section 8(h)(1), the manufacturer or processor shall comply with the requirements of subsection (b). A person shall submit to the Administrator data in accordance with the rule or order at the time that notice is submitted under subsection
(b)or
(c)if the person is required to submit to the Administrator— under subsection
(b)or (c), a notice prior to beginning the manufacture or processing of a chemical substance; and under section 4(b), test data for the chemical substance prior to the submission of the notice. Subject to section 14, the Administrator shall make any test data submitted under paragraph
(1)available on a publicly accessible Internet site. Except as provided under subsection (b)(2)(D)(iv), the Administrator may require a person subject to an information requirement for a chemical substance under this subsection or section 4 to submit the information— prior to and as a condition of the Administrator assigning the substance to a category; as a condition of commencement of manufacture or processing; or as a condition of exceeding a specified manufacturing volume or expanding use of the substance. A notice under subsection (b)(1) shall include— the chemical identity and any special substance characteristics of the chemical substance; the identity and primary business location of the manufacturer; the information described in section 8(h)(5)(B)(ii); the minimum information set described in section 4(a), where applicable; and a statement that— the new chemical substance is likely to meet the safety standard under section 6(d); or the 1 or more uses proposed for the new chemical substance meet the criteria described in section 6(h)(2)(B). A notice under subsection (c)(1) shall include all updates to the declaration described in section 8(b)(2) and information described in section 8(h)(5)(B)(ii) that is relevant to the new use, new production volume, or other new manner of manufacturing or processing. A notice under subsection (c)(2) shall include— all updates to the declaration described in section 8(b)(2); information described in section 8(h)(5)(B)(ii) that is relevant to the new use, new production volume, or other new manner of manufacturing or processing; all updates to the minimum information set described in section 4(a) relevant to the new use, new production volume, or other new manner of manufacturing or processing; and a statement that the chemical substance will continue to meet the safety standard if the allowed uses, production volumes, or other specified conditions or terms for that chemical substance are revised to encompass the new use, production volume, or other manner of manufacturing or processing. Subject to section 14, the Administrator shall make the notices under paragraph
(1)available on a publicly accessible Internet site. Subject to section 14, not later than 5 days (excluding Saturdays, Sundays, and legal holidays) after the date of the receipt of a notice under subsection (b), (c), or (d), or of data under subsection (f), the Administrator shall make available on a publicly accessible Internet site a notice that— identifies the chemical substance for which notice or information has been received; lists the uses or intended uses of the chemical substance; for substances for which a notice is submitted under subsection (b)(1), is promptly updated to specify the category to which the Administrator has assigned the substance pursuant to subsection (b)(2) once the assignment has been made; in the case of the receipt of data under subsection (f), describes— the nature of the tests performed with respect to the chemical substance; and any data that were received under subsection
(f)or a rule or order under section 4; and references the availability of the minimum information set, where applicable. At the beginning of each month, the Administrator shall make available on a publicly accessible Internet site a list of each chemical substance for which a notice has been received under subsection (b), (c), or (d). If the Administrator determines that scientific consensus exists that the intrinsic properties of a new chemical substance are such that the chemical substance does not and would not pose any risk of injury to human health or the environment under any intended or reasonably anticipated levels of production, patterns of use, or exposures arising at any stage across the lifecycle of the chemical substance, the Administrator may, by order, exempt the chemical substance, or particular uses of such substances, from 1 or more of the requirements of this section. A determination under clause (i)— shall be based on consideration of the intrinsic properties of the chemical substance; and shall not be based on findings or assumptions of low human or environmental exposure to such substances. Not later than 30 days after providing an exemption pursuant to subparagraph (A), the Administrator shall publish in the Federal Register a notice that— subject to section 14, provides the specific identity of the chemical substance or category; if a particular use of the chemical substance is exempted under subparagraph (A), describes the particular use of the chemical substance that the Administrator has exempted; and explains and documents the basis for the determination and exemption of the Administrator. The Administrator may reconsider and revoke or modify any exemption provided under subparagraph
(A)at any time if the Administrator determines that— the conditions specified in subparagraph
(A)are no longer met; or such action is necessary to protect human health or the environment or is otherwise in the public interest. In the event of a revocation or modification under clause (i), the Administrator shall publish a notice of the grounds for the revocation. Not later than 180 days after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall review exemptions that were granted pursuant to subsection (h)(4) of this section as in effect on the day before that date of enactment. An exemption described in subclause
(I)shall continue to be in effect until the date on which the Administrator determines, by order, that— the exemption is not appropriate under this section, at which time the exemption shall cease to be in effect; or the exemption is appropriate under this section, at which time the Administrator may issue an order to modify or continue in effect the exemption pursuant to subparagraph (A). Notwithstanding subparagraph
(A)and any previously issued exemption applicable to polymeric chemical substances— subsection
(d)shall apply to new polymeric chemical substances eligible for the previously issued exemption— during the period prior to a determination by the Administrator pursuant to clause
(i)applicable to such substances; and after a determination by the Administrator pursuant to clause (i)(II)(bb) that continuation of the prior exemption is appropriate for some or all such substances, for such substances to which the continuation applies; and all of this section shall apply to new polymeric chemical substances eligible for the previously issued exemption after a determination by the Administrator pursuant to clause (i)(II)(aa) that continuation of the prior exemption is not appropriate for some or all such substances, for such substances to which the determination applies. Nothing in this paragraph limits or otherwise affects the authority of the Administrator under any other provision of this Act. Subject to paragraph (6), the Administrator may, upon application, exempt any person from any requirement of subsection (b), (c), or
(f)to permit the person to manufacture or process a chemical substance for test marketing purposes— upon a showing by the person, in a manner that the Administrator determines, that the manufacture, processing, distribution in commerce, use, and disposal of the chemical substance (including any combination of those activities) will not endanger human health or the environment; and under such restrictions as the Administrator considers appropriate. The Administrator shall, upon application, fully or partially exempt any person from the requirement to submit any data under subsection
(b)or
(f)if, on receipt of an application, the Administrator determines that— the chemical substance for which the application was submitted is equivalent to a chemical substance for which data has been submitted to the Administrator as required by this Act; and submission of data by the applicant on the chemical substance would be duplicative of data which has been submitted to the Administrator in accordance with this Act. No exemption under this paragraph may take effect before the beginning of the reimbursement period applicable to the data. In this subparagraph, the term reimbursement period , with respect to any previously submitted data for a chemical substance, means a period— beginning on the date of the termination of the prohibition, imposed under this section, on the manufacture or processing of the chemical substance by the person who submitted the data to the Administrator; and ending on the later of— the date that is 5 years after the date referred to in subclause (I); or the expiration of the period, which begins on the date referred to in subclause
(I)and is equal to the period that the Administrator determines to be necessary to develop the data. Except as provided in clause (iii), if the Administrator exempts any person, under subparagraph (A), and the exemption is granted during the reimbursement period for that data, the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined by the Administrator)— to the person who previously submitted the data on which the exemption was based, for a portion of the costs incurred by the person in complying with the requirement under this title to submit the data; and to any other person who has been required under this subparagraph to contribute with respect to the costs, for a portion of the amount the person was required to contribute. Clause
(ii)shall not apply if the person exempted under that clause and the persons described in subclauses
(I)and
(II)of that clause agree on the amount and method of reimbursement. In promulgating rules for the determination of fair and equitable reimbursement to the persons described in subclauses
(I)and
(II)of clause
(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 the chemical substance of the person required to provide reimbursement to the share of the market of the persons to be reimbursed. If the conditions described in subparagraph
(B)are met, subsections (b), (c), and
(f)shall not apply with respect to the manufacturing or processing of any chemical substance that 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— scientific experimentation or analysis; or chemical research on, or analysis of the chemical substance or another chemical substance, including such research or analysis for the development of a product. All persons engaged in the experimentation, research, or analysis for a manufacturer or processor shall be notified (in such form and manner as the Administrator may prescribe) of any risk to human health that the manufacturer, processor, or the Administrator has reason to believe may be associated with that chemical substance. Subject to paragraph (6), the Administrator may, upon application, exempt from subsections (b), (c), and
(f)the manufacturing or processing of any chemical substance— that exists temporarily as a result of a chemical reaction in the manufacturing or processing of a mixture or another chemical substance; and to which there is no, and will not be, human or environmental exposure. As soon as practicable after the date of receipt of an application under paragraph
(2)or (5), the Administrator shall publish in the Federal Register notice of the receipt of the application. The Administrator shall— give interested persons an opportunity to comment upon any application described in subparagraph (A); not later than 45 days after the date of receipt of an application, approve or deny the application; and publish in the Federal Register notice of the approval or denial of the application. Each submission required under this section or under a rule or an order promulgated or issued by the Administrator under this section shall be accompanied by a certification signed by a responsible official of the manufacturer or processor that each statement contained in the submission— is accurate and reliable; and includes all material facts required by the applicable provision of this section or rule or order under this section. .
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Sec. 6
New chemical substances and new uses of chemical substances
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