Sec. 5. Minimum information sets and testing of chemical substances
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Section 4 of the Toxic Substances Control Act ( 15 U.S.C. 2603 ) is amended to read as follows: Subject to subparagraphs
(B)and (C), and not later than 1 year after the date of enactment of the Safe Chemicals Act of 2013 , the Administrator shall establish, by rule, such minimum information sets as the Administrator determines to be appropriate to evaluate chemical substances under sections 5 and 6. The rule promulgated pursuant to subparagraph
(A)shall— provide for varied or tiered information to be provided for different chemical substances; identify the particular minimum information set that applies to a chemical substance; require each minimum information set to include sufficient information for the Administrator to conduct a screening-level risk assessment of the chemical substance, including information on the characteristics, toxicological properties, environmental and biological fate and behavior, exposure, and use of a chemical substance; specify information quality and reliability requirements applicable to the information submitted in the minimum information sets; and accommodate the use of alternative testing methods and testing strategies to generate information quickly, at low cost, and with reduced use of animal-based testing, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening, to the extent such methods and strategies would yield information of equivalent quality and reliability. The rule promulgated pursuant to subparagraph
(A)shall establish minimum information sets sufficient for the Administrator to administer this Act, including to carry out— categorization of new chemical substances under section 5(b)(2), including the identification of information— sufficiently robust to generally support the categorization of a new chemical substance as a substance of very low concern under section 5(b)(2)(D)(iii)(II); and in the absence of which the Administrator shall designate a new chemical substance to be a substance with insufficient information under section 5(b)(2)(D)(iv); categorization of existing chemical substances under section 6(b)(3), including the identification of information— sufficiently robust to generally support the categorization of an existing chemical substance as a substance of very low concern under section 6(b)(3)(B)(ii); and in the absence of which the Administrator shall designate an existing chemical substance to be a substance with insufficient information under section 6(b)(3)(B)(iv); assignment of chemical substances to priority classes under section 6(b)(4); safety standard determinations— for new uses of existing chemical substances under section 5(b)(2); and for chemical substances under section 6(d); and safety standard redeterminations under section 6(d)(5)(E). Each manufacturer and processor of a chemical substance shall submit the minimum information set for the chemical substance to the Administrator— for new chemical substances, concurrent with the notice required under section (5)(b)(1)(A); and for existing chemical substances, as specified in section 6 or otherwise specified by the Administrator in the rule promulgated pursuant to paragraph (1)(A). In addition to any other authorities available under this Act, the Administrator may, by order, take any action authorized under section 6(f) if a manufacturer or processor is in violation of paragraph (2). The Administrator may, by rule or order, require testing with respect to any chemical substance, and the submission of test results by a specified date, as appropriate for making any determination or carrying out any provision of this Act. Such testing may be required— to provide information in addition to the information specified in any applicable minimum information set under subsection (a); and of persons to whom the Administrator decides not to apply a requirement to submit a minimum information set under subsection (a). Nothing in this paragraph limits the authority of the Administrator under paragraph (2). The Administrator may, by rule or order, require the submission of a sample of any chemical substance in such manner as the Administrator determines enables the Administrator to conduct any tests necessary for making any determination or carrying out any provision of this Act. Nothing in this paragraph limits the authority of the Administrator under paragraph (1). In addition to any other authorities available under this Act, the Administrator may, by order, take any action authorized under section 6(f) if a manufacturer or processor is in violation of a rule or order under paragraph (1). If a manufacturer or processor ceases all manufacture or processing of a chemical substance pursuant to its submission of a declaration of cessation of manufacture or processing under section 8(b)(4) for the chemical substance, the manufacturer or processor shall be exempted from the requirements of this subsection. A rule or order issued under subsection
(b)shall include— identification of the chemical substance for which testing is required under the rule or order; standards for the development of test information for that substance; and a specification of the period (which may not be of unreasonable duration) within which the persons required to conduct the testing shall submit to the Administrator information developed in accordance with the standards referred to in subparagraph (B). In determining the standards and period to be required under subparagraphs
(B)and
(C)of paragraph (1), the Administrator shall consider— the relative costs of the various test protocols and methodologies that may be required under the rule or order; and the reasonably foreseeable availability of the facilities and personnel needed to perform the testing required under the rule. Any rule or order issued by the Administrator under this subsection may require a manufacturer or processor to submit preliminary information during the period described in paragraph (1)(C). The Administrator may prescribe standards for the development of test information under this subsection for health and environmental information, including— information pertaining to carcinogenesis, mutagenesis, teratogenesis, behavioral disorders, or cumulative, synergistic, or any other effect that may be considered in a safety standard determination; information pertaining to exposure to the chemical substance, including information regarding the presence of the chemical substance in human blood, fluids, or tissue; and information pertaining to— bioaccumulation; persistence; acute toxicity; subacute toxicity; chronic toxicity; and any other characteristic that may present an adverse effect. The Administrator may prescribe methodologies in standards for the development of test information, including— epidemiologic studies; biomonitoring or environmental monitoring studies; serial or hierarchical tests; in vitro tests; whole animal tests, consistent with section 30; and any other methodology deemed appropriate by the Administrator. Prior to prescribing epidemiologic studies of employees, the Administrator shall consult with the Director of the National Institute for Occupational Safety and Health. Periodically, but not less frequently than once every 3 years, the Administrator shall— review the adequacy of the standards for development of information prescribed under subparagraph (A); and if necessary, institute proceedings to make appropriate revisions of those standards. Except as provided in subparagraph (B), a rule or order under subsection
(b)respecting a chemical substance shall specify the persons required to conduct tests and submit information to the Administrator on the substance. The Administrator may permit 2 or more of the persons described in subparagraph
(A)to designate 1 of the persons or a qualified third party to conduct the tests and submit the information on behalf of the persons making the designation. All persons described in subparagraphs
(A)and
(B)shall remain liable for compliance with any requirements subject to the designation. Any rule or order under subsection
(b)that requires the testing and submission of information for a particular chemical substance shall expire at the end of the applicable reimbursement period (as defined in subsection (d)(3)) unless, prior to that date, the Administrator withdraws the rule or order. A rule or order under subsection
(b)that requires the testing and submission of information for a category of chemical substances shall expire with respect to a chemical substance included in the category at the end of the applicable reimbursement period (as defined in subsection (d)(3)) unless, prior to that date, the Administrator withdraws the rule or order with respect to the substance entirely. Any person required by a rule or order under subsections
(a)or
(b)to conduct tests and submit information for a chemical substance may apply to the Administrator (in such form and manner as the Administrator determines necessary) for an exemption from the requirement. In accordance with paragraph
(3)or (4), the Administrator shall exempt an applicant under paragraph (1), if, on receipt of the application, the Administrator determines that— the chemical substance for which the application was submitted is equivalent to a chemical substance for which— information has been submitted to the Administrator in accordance with a rule or order under subsection
(a)or (b); or information is being developed in accordance with the rule or order; and submission of information by the applicant for the substance would be duplicative of information that— has been submitted to the Administrator in accordance with the rule or order under subsection
(a)or (b); or is being developed in accordance with the rule or order. In this paragraph, the term reimbursement period , with respect to any test information for a chemical substance, means a period that— begins on the date on which the test information is submitted in accordance with a rule or order issued under subsection
(a)or (b); and ends on the later of— 5 years after the date referred to in clause (i); and the date which, as determined by the Administrator, provides the applicant with a time period which is sufficient to develop the test information. Except as provided in clause (ii), for an exemption under paragraph (2)(B)(i), if the exemption is granted during the reimbursement period for the test information, 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 test information, for a portion of the costs incurred by the person in complying with the information submission requirement; and any other person who has been required under this subsection to contribute with respect to the costs, for a portion of the amount the person was required to contribute. Clause
(i)shall not apply if there is agreement on the amount and method of reimbursement between an exempted person described in clause
(i)and the persons described in subclauses
(I)and
(II)of that clause. In promulgating rules for the determination of fair and equitable reimbursement to the persons described in subclauses
(I)and
(II)of clause
(i)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 person to be reimbursed; and the share of the market for the substance of the person required to provide reimbursement in relation to the share of the market of the persons to be reimbursed. Except as provided in clause (ii), for an exemption under paragraph (2)(B)(ii), the Administrator shall order the person granted the exemption to provide fair and equitable reimbursement (in an amount determined by the Administrator) to— each person who is developing the test information, for the portion of the costs incurred by each person in complying with the rule or order; and any other person who has been required under this subsection to contribute with respect to the costs of complying with the rule or order, for a portion of the amount the person was required to contribute. Clause
(i)shall not apply if there is agreement on the amount and method of reimbursement between an exempted person described in clause
(i)and the persons described in subclauses
(I)and
(II)of that clause. In promulgating rules for the determination of fair and equitable reimbursement to the persons described in subclauses
(I)and
(II)of clause
(i)for costs incurred with respect to a chemical substance, the Administrator shall, after consultation with the Attorney General and the Federal Trade Commission, consider the factors described in subparagraph (B)(iii). If any exemption is granted under paragraph
(2)on the basis that 1 or more persons are developing test information pursuant to a rule or order promulgated or issued under subsection
(a)or (b), and after the exemption is granted, the Administrator determines that no person has complied with the rule or order, the Administrator shall— after providing written notice and an opportunity for a hearing to the person who holds the exemption, by order, terminate the exemption; and notify in writing the person of the requirements of the rule or order with respect to which the exemption was granted. Not later than 15 days after the date of receipt of any test information pursuant to a rule or order under subsection
(a)or (b), the Administrator shall publish in the Federal Register a notice of the receipt of the test information. Subject to section 14, each notice shall— identify the chemical substance for which information has been received; list— the commercial and consumer uses or intended commercial and consumer uses of the substance known to the Administrator; and the information required by the applicable standards for the development of test information; and describe the nature of the test information developed. Subject to section 14, the Administrator shall make the test information described in this subsection available on a publicly accessible Internet site. The head of a Federal agency may request the Administrator to seek the information on behalf of that agency if the head of that Federal agency determines that— information relating to a chemical substance, including information derived from new testing or monitoring, would assist that Federal agency in carrying out the duties or exercising the authority of that agency; but the requested information is not available to that agency. Not later than 60 days after the date of receipt of a request under paragraph (1), the Administrator shall— subject to section 14, make the information available to the requesting agency or institution; issue a request under section 8(k) to require— the submission of existing pertinent information to the Administrator; and a copy of any such submission to be furnished to the requesting agency or institution; issue a rule or order under subsection (b)— to develop the information; and to require the developed information to be furnished to the requesting agency or institution; or publish in the Federal Register the reason for which none of the actions described in this paragraph were taken. Each person who submits information under this section or under a rule or an order promulgated or issued by the Administrator under this section shall accompany the information with a certification signed by a responsible official that each statement contained in the submission— is accurate and reliable; and includes all material facts known to, in the possession or control of, or reasonably ascertainable by, the person. .
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Sec. 5
Minimum information sets and testing of chemical substances
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