Sec. 9. Reporting and retention of information
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Section 8 of the Toxic Substances Control Act ( 15 U.S.C. 2607 ) is amended to read as follows: In this section: The term known to, or reasonably ascertainable by has the meaning given the term in section 704.3 of title 40, Code of Federal Regulations (or successor regulations). The terms manufacture and process mean manufacture and process, respectively, for commercial purposes. The declarations described in this subsection shall apply only to chemical substances in commerce as of the date of enactment of the Safe Chemicals Act of 2013 .
The following criteria shall apply in identifying chemical substances to which the declarations described in this subsection apply: A chemical substance in which a manufacturer or processor has a current commercial interest shall include only chemical substances that the manufacturer or processor— is currently manufacturing or processing; or has manufactured or processed in the recent past and expects to manufacture or process again in the near future. A chemical substance in which a manufacturer or processor has a potential commercial interest shall include only a chemical substance that may serve as a reasonable substitute for a chemical substance in which the manufacturer or processor has declared a current commercial interest.
Not later than 90 days after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall issue guidance further describing the criteria described in subparagraph
(B)and specifying the supporting information manufacturers and processors are to include in declarations they submit pursuant to paragraph
(2)or
(3)for chemical substances in which they have a current or potential commercial interest. Notwithstanding any other provision of law, not later than 180 days after the date of enactment of the Safe Chemicals Act of 2013 , each manufacturer of a chemical substance in which the manufacturer has a current commercial interest shall submit to the Administrator a declaration of the interest for the chemical substance. Declarations are required for all chemical substances in which a manufacturer has a current commercial interest, notwithstanding any exclusions or exemptions from other notification or reporting requirements provided in any other provision of this Act. A processor of a chemical substance in which the processor has a current commercial interest that meets the criteria described in paragraph (1)(B)(i) may voluntarily submit to the Administrator a declaration for the chemical substance. Such a declaration shall be submitted not later than 1 year after the date of enactment of the Safe Chemicals Act of 2013 . A manufacturer or processor may voluntarily submit to the Administrator, not later than 180 days after the date of enactment of the Safe Chemicals Act of 2013 , a declaration for a chemical substance in which the manufacturer or processor— does not have a current commercial interest; but has a potential commercial interest that meets the criteria described in paragraph (1)(B)(ii). If a manufacturer or processor commences the manufacture or processing of a chemical substance for which it submitted a declaration under this paragraph, the manufacturer or processor shall comply with the requirements of subsection (h)(5)(B). A former or current manufacturer or processor of a chemical substance in which the manufacturer or processor no longer has a commercial interest may voluntarily submit to the Administrator, not later than 180 days after the date of enactment of the Safe Chemicals Act of 2013 , a declaration that the manufacturer or processor has ceased, or will cease not later than 180 days after the date on which the declaration is submitted, all production, importation, processing, and export of the chemical substance. A declaration submitted under this subsection shall include for each chemical substance— the chemical identity and any special substance characteristics of the chemical substance; the identity and primary business location of the manufacturer or processor; and information supporting the declarant’s basis for meeting the applicable criteria under paragraph (1)(B). The Administrator shall— review each declaration received under this subsection to determine whether the declaration conforms to the criteria and requirements of this subsection; and for a chemical substance for which 1 or more conforming declarations are submitted under paragraph (2), add the chemical substance to the list of active chemical substances in the inventory established under subsection (h)(1); for a chemical substance for which the only conforming declarations submitted for the substance are submitted under paragraph (3), add the chemical substance to the list of inactive chemical substances in the inventory established under subsection (h)(5); and for a chemical substance for which the only conforming declarations submitted for the substance are submitted under paragraph (4), or for which no declaration has been submitted, remove the chemical substance from the inventories established under subsection (h). The Administrator shall allow a manufacturer or processor, as applicable, to promptly revise and resubmit any declaration submitted to the Administrator under this subsection if the Administrator determines that any omission or error in the original declaration was not intentional. The Administrator shall— maintain the periodic reporting program of the agency applicable to manufacturers of chemical substances set forth in part 711 of title 40, Code of Federal Regulations (as in effect on the date of enactment of the Safe Chemicals Act of 2013 ), unless such reporting requirements are superseded pursuant to subparagraph (B); or establish a new periodic reporting program consistent with this subsection. Not later than 180 days after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall specify, by rule— the chemical substances for which periodic reporting is required; and the information a chemical manufacturer is required to submit to the Administrator for the chemical substances included under the periodic reporting program. The rule promulgated under subparagraph
(A)may exempt certain manufacturers, including small manufacturers, from— a requirement to participate in the periodic reporting program, if the Administrator determines that the participation of those manufacturers would not assist in the administration of this Act; or specific reporting requirements, if the Administrator determines that the value of a particular reporting requirement, for the administration of this Act, would not be commensurate with the burden of the requirement on submitters. The rule promulgated under subparagraph
(A)shall, at a minimum, require each manufacturer of a chemical substance included in the periodic reporting program to submit to the Administrator— the chemical identity and any special substance characteristics of the chemical substance, the identity and primary business location of the manufacturer, and any updates to the supporting information submitted by the manufacturer in any declaration for an included chemical substance submitted under subsection (b); a list of health and safety studies conducted or initiated by or for, known to, or reasonably ascertainable by, the manufacturer with respect to each included chemical substance; a copy of each study described in clause
(ii)in the possession or control of the manufacturer that has not previously been submitted to the Administrator; and all other information specified by the Administrator in the rules promulgated under this subsection that is known to, in the possession or control of, or reasonably ascertainable by, the manufacturer or processor that has not previously been submitted to the Administrator regarding— the physical, chemical, and toxicological properties of the chemical substance; the manufacturer’s annual production volume of the chemical substance; the uses of, and exposure and fate information relating to the manufacturer’s production or import of the chemical substance; and the name and location of each facility to which the manufacturer sends the chemical substance after manufacture for subsequent processing, distribution, or use. Each manufacturer and processor of a chemical substance that is distributed in commerce shall— maintain records of the information submitted to the Administrator under subsections
(b)and (c), as well as supporting information; and submit those records or that information to the Administrator upon request by the Administrator. Each manufacturer and processor that submits to the Administrator a declaration under subsection
(b)or a notice under subsection (h)(5)(B) shall at all times bear the burden of proving that the manufacturer or processor— has a current or potential commercial interest in the applicable chemical substance; or has ceased the production, importation, processing, and export of, the applicable chemical substance. Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall specify, by rule, the information that chemical processors are required to submit for chemical substances under this subsection as will assist the Administrator in the administration of this Act. The rule promulgated under this paragraph may exempt certain processors, including small processors, from— a requirement to participate in the periodic reporting program, if the Administrator determines that the participation of those processors would not assist in the administration of this Act; or specific reporting requirements, if the Administrator determines that the value of a particular reporting requirement, for the administration of this Act, would not be commensurate with the burden of the requirement on submitters. The rule promulgated under paragraph
(1)shall— specify the information that processors are required to submit for chemical substances that are— processed for use in 1 or more consumer or commercial product categories, as determined by the Administrator; and intentionally added to 1 or more products during processing and not incidental to the end uses of the products; require each processor of a chemical substance identified under subparagraph
(A)to submit the information specified in clauses
(i)through
(iii)of subparagraph
(C)for the chemical substance, and to submit the information specified in clauses
(iv)through
(viii)of subparagraph (C)— separately for each applicable consumer and commercial product category; and in aggregate form, taking into account the use by the processor of the chemical substance in all product categories; require each processor of a chemical substance identified under subparagraph
(A)to identify in the submission of the processor— the corporate name and primary business location of the processor; the chemical identity and any special substance characteristics of the chemical substance; the applicable consumer or commercial product category or categories for which the processor processes the chemical substance; the annual volume of the chemical substance processed by the submitter; any products intended for use by children aged 14 years or younger for use in which the processor processes the chemical substance; the concentration range within which the maximum concentration of the substance used in each consumer and commercial product category falls; the range within which the total number of commercial workers reasonably likely to be exposed to the chemical substance at the processing site falls; and any other information regarding processing activities or product descriptors relating to the processor’s processing of the chemical substance identified by the Administrator as necessary to understand the potential exposure from processed chemical substances or products in which the chemical substances are used; and require each processor to periodically report the information described in subparagraphs
(B)and
(C)for the chemical substances described in subparagraph (A). The rules promulgated under paragraph
(1)shall require processors of chemical substances to which those rules apply— to maintain records of the information described in paragraph (2); and to submit those records to the Administrator upon request by the Administrator. Each manufacturer or processor of a chemical substance that submits information to the Administrator under subsection
(c)or
(e)shall update the information— at a minimum every 4 years; and at any time that— the manufacturer or processor obtains knowledge of, comes into possession of, or generates significant new information regarding the production, processing, use, distribution, hazard, or exposure potential of the chemical substance; or there is a significant change in the production, distribution in commerce, or use of the chemical substance by or known to the manufacturer or processor. Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall issue guidance on what constitutes significant new information regarding or significant changes in the production, distribution in commerce, or use of a chemical substance. Except as provided in paragraph (2), the Administrator may by rule or order require any person who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance, or a mixture or article containing the chemical substance to maintain records of and report by a specified date any existing information concerning the substance that, in the judgment of the Administrator, would assist the Administrator in— making a safety standard determination with respect to a chemical substance; determining testing or information needs for a chemical substance; assigning a chemical substance to a batch, category, or priority class pursuant to section 6; evaluating, developing, and implementing risk management conditions for a chemical substance; assessing hazards, exposures, or risks related to the manufacture, use, distribution, processing, or disposal of a chemical substance; determining compliance with any provision of this Act; or any other aspect of administering this Act. The Administrator may by rule or order require that any report or information submitted pursuant to this Act include chemical identity and special substance characteristics, as appropriate to the chemical substance that is the subject of the report or information. The Administrator shall by rule or order specify or modify the information that is required to be submitted with a particular report or information submission to establish the chemical identity and special substance characteristics of the subject chemical substance (or mixture or article containing that chemical substance) for the purposes of the report or information submission. In the case of the manufacture, processing, distribution in commerce, use, or disposal of a chemical substance in small quantities (as defined by the Administrator by rule) solely for purposes of scientific experimentation or analysis or chemical research (including any such research or analysis for the development of a product), the Administrator may promulgate a rule or order under paragraph
(1)only to the extent that the Administrator determines that the maintenance of records, submission of reports, or both, is necessary for the effective enforcement of this Act. The rules promulgated under this subsection may exempt certain small businesses from the rules promulgated under this subsection, if the Administrator determines that the participation of those small businesses would not assist in the administration of this Act. The Administrator shall compile, keep current, and, subject to section 14, publish a list of each chemical substance that is manufactured or processed in the United States. The list shall consist of those chemical substances for which— a notice is submitted under section 5(d), consistent with the requirements of section 5(b); or a valid declaration is submitted under paragraph
(2)of subsection (b). The list shall not include— any chemical substance for which the only declarations submitted are submitted under paragraph
(3)or
(4)of subsection (b), or for which no declaration has been submitted; or any chemical substance for which an exemption has been granted under section 5(b)(1)(C)(ii) or section 6(h)(2). Except as provided in paragraph (2)(B), for a chemical substance for which a notice is submitted under section 5(d), the chemical substance shall be included in the list established under paragraph
(1)as of the earliest date (as determined by the Administrator) on which the substance was manufactured or processed in the United States. The Administrator shall first publish a list under paragraph
(1)not later than 1 year after the date of enactment of the Safe Chemicals Act of 2013 . The Administrator shall not include in the list established under paragraph
(1)any chemical substance that is 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 substance or another substance, including research or analysis for the development of a product. The Administrator shall compile, keep current, and, subject to section 14, publish an inactive list on which the Administrator shall include each chemical substance for which the only declarations submitted for the substance are submitted under subsection (b)(3). If a manufacturer or processor commences the manufacture or processing of a chemical substance on the inactive list, the manufacturer or processor shall— not less than 30 days before recommencing the manufacture or processing of the chemical substance, notify the Administrator; and provide with the notification under clause (i)— the chemical identity and any special substance characteristics of the chemical substance; the identity and primary business location of the manufacturer; a list of health and safety studies conducted or initiated by or for, known to, or reasonably ascertainable by, the manufacturer or processor with respect to the chemical substance; upon request of the Administrator, a copy of each study described in subclause
(III)in the possession or control of the manufacturer that has not previously been submitted to the Administrator; the projected annual manufacturing or processing volume for the chemical substance for each of the subsequent 3 years; the name and location of each facility to which the chemical substance is expected to be sent, after manufacture or processing, for subsequent processing, distribution in commerce, or use; and all other existing information known to, in the possession or control of, or reasonably ascertainable by the manufacturer or processor that has not previously been submitted to the Administrator regarding— the toxicological properties of the chemical substance; and the uses of, and exposure and fate information relating to, the chemical substance. For any chemical substance for which the Administrator receives a valid notification under subparagraph (B), the Administrator shall promptly— move the chemical substance to the active inventory established under paragraph (1); and add the chemical substance to the current batch of chemical substances identified pursuant to section 6(a), and categorize the chemical substance with other chemical substances in the batch, pursuant to section 6(b). Disclosure of any information provided in the notice described in subparagraph
(B)shall be subject to section 14. If a manufacturer or processor seeks to commence the manufacture or processing of a chemical substance that is not listed on the inventories established under paragraph
(1)or (5), or that has been removed from the inventories pursuant to subsection (b)(6)(A)(ii)(III), the manufacturer or processor shall comply with section 5. Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator, through collaboration as appropriate, shall establish— an electronic, Internet-accessible database for the storing and sharing of information relating to the toxicity and use of, and exposure to, chemical substances; and procedures for use in maintaining and updating the database. Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2013 or for decisions made or information submitted after that 18-month period, not later than 90 days after the date on which a decision is made by the Administrator or information submitted under this title is received by the Administrator, the Administrator shall, subject to section 14, make available to the public via the Internet-accessible database described in paragraph
(1)a description of all significant— decisions made by the Administrator under this title; and information submitted pursuant to this title. Any person that manufactures, processes, or distributes in commerce any chemical substance shall maintain, and on request submit to the Administrator, records of significant adverse reactions to human health or the environment, as determined by the Administrator by rule, alleged to have been caused by the substance or mixture. Records of the adverse reactions to the health of employees shall be retained for a period of 30 years after the date on which the reactions were first reported to or known by the person maintaining the records. Any record of other adverse reactions shall be retained for a period of 5 years after the date on which information contained in the record was first reported to or known by the person maintaining the record. Records required to be maintained under this subsection shall include— records of consumer allegations of personal injury or harm to health; reports of occupational disease or injury; and reports or complaints of injury to the environment submitted to the manufacturer, processor, or distributor in commerce from any source. Notwithstanding any other provision of law, from time to time, each Federal agency and Federal institution shall submit to the Administrator a synopsis of the data and records in the possession or control of the agency or institution, respectively, that may be useful to the Administrator in carrying out this Act. Not later than 1 year after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall prescribe, by order, the format, content, and level of detail of the synopses. Not later than 18 months after the date of enactment of the Safe Chemicals Act of 2013 , each Federal agency and Federal institution shall make the initial submission of a synopsis of the agency and institution, respectively, to the Administrator. At least once every 3 years, each Federal agency and Federal institution shall— update the synopsis of the agency and institution, respectively; and submit the updated synopsis to the Administrator. Notwithstanding any other provision of law, on the request of the Administrator, any information in the possession or control of an agency or institution relating to a hazard of, use of, exposure to, or risk of, a chemical substance (or mixture or article containing that chemical substance) shall be submitted to the Administrator. Any person that manufactures, processes, or distributes in commerce a chemical substance and that obtains information that reasonably supports the conclusion that the substance presents a substantial risk of injury to health or the environment shall immediately inform the Administrator of the information unless the person has actual knowledge that the Administrator has been adequately informed of the information. Each submission required pursuant to this section or pursuant to a rule or an order promulgated or issued by the Administrator under this section, other than a submission under subsection (k), shall be accompanied by a certification signed by a responsible official of the manufacturer, processor, distributor, user, or disposer of a chemical substance 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. Nothing in this section limits the authority of the Administrator to require reporting under any other provision of this Act by any person who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance, or a mixture or article containing a chemical substance. In addition to all other authorities available for the enforcement of this Act, the Administrator may, by order, take any action authorized under section 6(f) if a person who manufactures, processes, distributes in commerce, uses, or disposes of a chemical substance, or a mixture or article containing a chemical substance violates any provision of this section. .
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Sec. 9
Reporting and retention of information
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