Sec. 10. Information collection and reporting
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Section 8 of the Toxic Substances Control Act ( 15 U.S.C. 2607 ) is amended— in subsection (a)— in paragraph (3)— in subparagraph (A)(ii)(I)— by striking 5(b)(4) and inserting 5 ; by inserting section 4 or after in effect under ; and by striking 5(e), and inserting 5(d)(4); ; and by adding at the end the following: Not later than 180 days after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , and not less frequently than once every 10 years thereafter, the Administrator, after consultation with the Administrator of the Small Business Administration, shall— review the adequacy of the standards prescribed according to subparagraph (B); after providing public notice and an opportunity for comment, make a determination as to whether revision of the standards is warranted; and revise the standards if the Administrator so determines. ; and by adding at the end the following:
Not later than 2 years after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall promulgate rules requiring the maintenance of records and the reporting of additional information known or reasonably ascertainable by the person making the report, including rules applicable to processors so that the Administrator has the information necessary to carry out this title. In carrying out this subparagraph, the Administrator may modify, as appropriate, rules promulgated before the date of enactment of the Frank R.
Lautenberg Chemical Safety for the 21st Century Act . The rules promulgated pursuant to subparagraph (A)— may impose different reporting and recordkeeping requirements on manufacturers and processors; and shall include the level of detail necessary to be reported, including the manner by which use and exposure information may be reported. In implementing the reporting and recordkeeping requirements under this paragraph, the Administrator shall take measures— to limit the potential for duplication in reporting requirements; to minimize the impact of the rules on small manufacturers and processors; and to apply any reporting obligations to those persons likely to have information relevant to the effective implementation of this title. ; in subsection (b), by adding at the end the following:
In carrying out paragraph (1), the Administrator shall— maintain the use of Class 2 nomenclature in use on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ; maintain the use of the Soap and Detergent Association Nomenclature System, published in March 1978 by the Administrator in section 1 of addendum III of the document entitled Candidate List of Chemical Substances , and further described in the appendix A of volume I of the 1985 edition of the Toxic Substances Control Act Substances Inventory (EPA Document No.
EPA–560/7–85–002a); and treat all components of categories that are considered to be statutory mixtures under this Act as being included on the list published under paragraph
(1)under the Chemical Abstracts Service numbers for the respective categories, including, without limitation— cement, Portland, chemicals, CAS No. 65997–15–1; cement, alumina, chemicals, CAS No. 65997–16–2; glass, oxide, chemicals, CAS No. 65997–17–3; frits, chemicals, CAS No. 65997–18–4; steel manufacture, chemicals, CAS No. 65997–19–5; and ceramic materials and wares, chemicals, CAS No. 66402–68–4. If an existing guidance allows for multiple nomenclature conventions, the Administrator shall— maintain the nomenclature conventions for substances; and develop new guidance that— establishes equivalency between the nomenclature conventions for chemical substances on the list published under paragraph (1); and permits persons to rely on the new guidance for purposes of determining whether a chemical substance is on the list published under paragraph (1). For any chemical substance appearing multiple times on the list under different Chemical Abstracts Service numbers, the Administrator shall develop guidance recognizing the multiple listings as a single chemical substance. Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator, by rule, shall require manufacturers and processors to notify the Administrator, by not later than 180 days after the date of promulgation of the rule, of each chemical substance on the list published under paragraph
(1)that the manufacturer or processor, as applicable, has manufactured or processed for a nonexempt commercial purpose during the 10-year period ending on the day before the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act . The Administrator shall designate chemical substances for which notices are received under clause
(i)to be active substances on the list published under paragraph (1). The Administrator shall designate chemical substances for which no notices are received under clause
(i)to be inactive substances on the list published under paragraph (1). In promulgating the rule established pursuant to subparagraph (A), the Administrator shall— maintain the list under paragraph (1), which shall include a confidential portion and a nonconfidential portion consistent with this section and section 14; require a manufacturer or processor that is submitting a notice pursuant to subparagraph
(A)for a chemical substance on the confidential portion of the list published under paragraph
(1)to indicate in the notice whether the manufacturer or processor seeks to maintain any existing claim for protection against disclosure of the specific identity of the substance as confidential pursuant to section 14; and require the substantiation of those claims pursuant to section 14 and in accordance with the review plan described in subparagraph (C). Not later than 1 year after the date on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A), the Administrator shall promulgate a rule that establishes a plan to review all claims to protect the specific identities of chemical substances on the confidential portion of the list published under paragraph
(1)that are asserted pursuant to subparagraph (B). Under the review plan under subparagraph (C), the Administrator shall— require, at the time requested by the Administrator, all manufacturers or processors asserting claims under subparagraph
(B)to substantiate the claim unless the manufacturer or processor has substantiated the claim in a submission made to the Administrator during the 5-year period ending on the date of the request by the Administrator; in accordance with section 14— review each substantiation— submitted pursuant to clause
(i)to determine if the claim warrants protection from disclosure; and submitted previously by a manufacturer or processor and relied on in lieu of the substantiation required pursuant to clause (i), if the substantiation has not been previously reviewed by the Administrator, to determine if the claim warrants protection from disclosure; approve, modify, or deny each claim; and except as provided in this section and section 14, protect from disclosure information for which the Administrator approves such a claim for a period of 10 years, unless, prior to the expiration of the period— the person notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall promptly make the information available to the public; or the Administrator otherwise becomes aware that the need for protection from disclosure can no longer be substantiated, in which case the Administrator shall take the actions described in section 14(g)(2); and encourage manufacturers or processors that have previously made claims to protect the specific identities of chemical substances identified as inactive pursuant to subsection (f)(2) to review and either withdraw or substantiate the claims. The Administrator shall implement the review plan so as to complete reviews of all claims specified in subparagraph
(C)not later than 5 years after the date on which the Administrator compiles the initial list of active substances pursuant to subparagraph (A). The Administrator may extend the deadline for completion of the reviews for not more than 2 additional years, after an adequate public justification, if the Administrator determines that the extension is necessary based on the number of claims needing review and the available resources. At the beginning of each year, the Administrator shall publish an annual goal for reviews and the number of reviews completed in the prior year. The Administrator shall maintain and keep current designations of active substances and inactive substances on the list published under paragraph (1). Any person that intends to manufacture or process for a nonexempt commercial purpose a chemical substance that is designated as an inactive substance shall notify the Administrator before the date on which the inactive substance is manufactured or processed. If a person submitting a notice under clause
(i)for an inactive substance on the confidential portion of the list published under paragraph
(1)seeks to maintain an existing claim for protection against disclosure of the specific identity of the inactive substance as confidential, the person shall— in the notice submitted under clause (i), assert the claim; and by not later than 30 days after providing the notice under clause (i), substantiate the claim. On receiving a notification under clause (i), the Administrator shall— designate the applicable chemical substance as an active substance; pursuant to section 14, promptly review any claim and associated substantiation submitted pursuant to clause
(ii)for protection against disclosure of the specific identity of the chemical substance and approve, modify, or deny the claim; except as provided in this section and section 14, protect from disclosure the specific identity of the chemical substance for which the Administrator approves a claim under subclause
(II)for a period of 10 years, unless, prior to the expiration of the period— the person notifies the Administrator that the person is withdrawing the claim, in which case the Administrator shall promptly make the information available to the public; or the Administrator otherwise becomes aware that the need for protection from disclosure can no longer be substantiated, in which case the Administrator shall take the actions described in section 14(g)(2); and pursuant to section 4A, review the priority of the chemical substance as the Administrator determines to be necessary. The list of inactive substances shall not be considered to be a category for purposes of section 26(c). Prior to the promulgation of the rule required under paragraph (4)(A), the Administrator shall designate the chemical substances reported under part 711 of title 40, Code of Federal Regulations (as in effect on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ), during the reporting period that most closely preceded the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , as the interim list of active substances for the purposes of section 4A. Subject to this subsection, the Administrator shall make available to the public— the specific identity of each chemical substance on the nonconfidential portion of the list published under paragraph
(1)that the Administrator has designated as— an active substance; or an inactive substance; the accession number, generic name, and, if applicable, premanufacture notice case number for each chemical substance on the confidential portion of the list published under paragraph
(1)for which a claim of confidentiality was received; and subject to subsections
(f)and
(g)of section 14, the specific identity of any active substance for which— a claim for protection against disclosure of the specific identity of the active chemical substance was not asserted, as required under this subsection or subsection
(d)or
(f)of section 14; a claim for protection against disclosure of the specific identity of the active substance has been denied by the Administrator; or the time period for protection against disclosure of the specific identity of the active substance has expired. No person may assert a new claim under this subsection for protection from disclosure of a specific identity of any active or inactive chemical substance for which a notice is received under paragraph (4)(A)(i) or (5)(C)(i) that is not on the confidential portion of the list published under paragraph (1). Under the rules promulgated under this subsection, manufacturers and processors shall be required— to certify that each notice or substantiation the manufacturer or processor submits complies with the requirements of the rule, and that any confidentiality claims are true and correct; and to retain a record supporting the certification for a period of 5 years beginning on the last day of the submission period. ; in subsection (e)— by striking Any person and inserting the following: Any person ; and by adding at the end the following: Any person may submit to the Administrator information reasonably supporting the conclusion that a chemical substance or mixture presents, will present, or does not present a substantial risk of injury to health and the environment. ; and in subsection (f), by striking For purposes of this section, the and inserting the following: In this section: The term active substance means a chemical substance— that has been manufactured or processed for a nonexempt commercial purpose at any point during the 10-year period ending on the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act ; that is added to the list published under subsection (b)(1) after that date of enactment; or for which a notice is received under subsection (b)(5)(C). The term inactive substance means a chemical substance on the list published under subsection (b)(1) that does not meet any of the criteria described in paragraph (1). The .
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Sec. 10
Information collection and reporting
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