Sec. 6. Safety assessments and determinations
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/bill/113/s/1009/is/section-6A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Section 6 ( 15 U.S.C. 2605 ) is amended— by striking the section designation and heading and inserting the following: ; by striking subsections
(a)through
(d)and inserting the following: The Administrator shall— conduct a safety assessment of each high-priority substance in accordance with subsection (b); make a safety determination for each high-priority substance; and as appropriate based on the results of a safety determination, establish requirements for risk management of a high-priority substance. The Administrator shall conduct a risk-based safety assessment of each high-priority substance, in accordance with such schedule as the Administrator establishes, to be based solely on considerations of risk to human health and the environment. The Administrator shall establish procedural rules for safety assessments and determinations under this subsection, including schedules for the submission of relevant data and information and the initiation and completion of safety assessments and safety determinations. The rules under subparagraph
(A)shall— identify the basis on which the Administrator shall decide which high-priority substances take precedence in the safety assessment and determination process; require the Administrator to inform the public regarding— the approximate order in which safety assessments and determinations will be performed; the informational needs of the Administrator relating to the safety assessment and determination process; the importance of expeditiously completing safety assessments and determinations and the need for rigorous evaluation of the data and information; the schedule by which each assessment and determination will be conducted; and subject to clause (ii), the deadline for the completion of each assessment and determination; allow interested persons, including States, to submit information, including safety assessments, regarding high-priority substances that may facilitate the safety assessment and determination process; and subject to section 14, require the Administrator— to make available to the public the information taken into consideration in preparing each safety assessment and determination; to publish and provide an opportunity for comment on proposed safety assessments and determinations; and to publish final safety assessments and determinations. The rules described in subparagraph
(A)shall also include— a schedule by which each safety assessment and determination is expected to be conducted; and a deadline for the completion of each assessment and determination. The deadlines described in subclause (I)(bb)— may vary among chemical substances to grant the Administrator flexibility; and shall allow for reasonable extensions after an adequate public justification. Each safety assessment under this subsection shall include— a weight-of-the evidence summary; and a nontechnical summary explaining what the relevant information demonstrates in the context of the intended conditions of use and exposure patterns of the chemical substance. In conducting a safety assessment under this subsection, the Administrator shall, at a minimum, take into consideration— the information described in section 4(c); and any additional information submitted under paragraph (5). The Administrator shall— develop an appropriate science-based methodology for conducting safety assessments under this subsection, which shall include consideration of the weight of the evidence for observed effects, mechanistic information, and exposure evaluations; and make the proposed methodology available for public comment and scientific peer review. Not later than 5 years after the date of enactment of the Chemical Safety Improvement Act , and not less frequently than once every 5 years thereafter, the Administrator— shall review the methodology developed under subparagraph (A); and may revise the methodology to reflect new scientific developments or understandings, in accordance with subparagraph (A). The methodology shall apply scientifically recognized factors to address the following topics: Strengths and limitations of study design. Reliability and relevance of test methods to human health and the environment. Quality of data. Use of good laboratory practices. Peer review and peer review processes. Use of standardized protocols. Structured evaluative frameworks to determine the overall weight of the evidence, based on a review of positive and negative findings. A safety assessment under this subsection shall evaluate existing hazard, use, and exposure information for the chemical substance under the intended conditions of use of the chemical substance, including information submitted by interested persons. For purposes of evaluating exposure under clause (i), a safety assessment shall take into consideration— exposures or significant subsets of exposures; exposure duration, intensity, frequency, and number; and the vulnerability of exposed subpopulations. The Administrator shall use the best available science in conducting a safety assessment under this subsection. If the Administrator determines that additional test information is needed in order to make a safety assessment for a high-priority substance, the Administrator— shall provide an opportunity for interested persons to submit the additional information; may promulgate a rule, enter into a testing consent agreement, or issue an order under section 4 to require the development of the information; and may defer, for a reasonable period, a safety assessment until after receipt of the information. A safety assessment under this subsection— shall not be considered to be a final agency action; and shall not be subject to judicial review. As soon as possible after the date on which the safety assessment is completed for a high-priority substance under subsection (b), the Administrator shall determine whether the chemical substance meets the safety standard under the intended conditions of use of the chemical substance. Based on a review of the information described in paragraph (3), the Administrator shall determine, based solely on considerations of risk to human health and the environment, that— the relevant chemical substance meets the safety standard under intended conditions of use; the relevant chemical substance does not meet the safety standard under intended conditions of use, in which case the Administrator shall impose additional restrictions, as appropriate, under paragraph (9); or additional information is necessary in order to make a determination under subparagraph
(A)or (B), in which case the Administrator shall take appropriate action under paragraph (8). In making a safety determination under this subsection, the Administrator shall take into consideration and publish a statement that includes, at a minimum— the safety assessment for the chemical substance, including the uses considered in the assessment and any uses that are considered critical or essential; the range of exposure to the chemical substance under the intended conditions of use of the chemical substance and appropriate reference parameters; the weight of the evidence of risk posed by the chemical substance under the intended conditions of use of the chemical substance; and the magnitude of the risk posed by the chemical substance under the intended conditions of use of the chemical substance. In making a safety determination under this subsection, the Administrator shall take into consideration, at a minimum— the information described in section 4(c); and the safety assessment conducted with respect to the chemical substance under subsection (b). The Administrator shall use the best available science in making a safety determination under this subsection. Subject to section 14, the Administrator shall provide notice and an opportunity for public comment on each proposed safety determination under this subsection. Subject to section 14, the Administrator shall publish— each safety determination under this subsection, together with a summary of the information considered in the determination; a summary of the evaluation by the Administrator of the information; and an explanation of the reasons for the determination. If the Administrator determines that additional test data and information is needed in order to make a safety determination for a high-priority substance, the Administrator— shall provide an opportunity for interested persons to submit the additional data and information; may promulgate a rule, enter into a testing consent agreement, or issue an order under section 4 to require the development of the data and information; may defer, for a reasonable period, a safety determination until after receipt of the data and information; and on receipt of the data and information, shall make a determination under paragraph (2). If the Administrator makes a determination under paragraph (2)(B) with respect to a chemical substance, the Administrator shall promulgate a rule establishing necessary restrictions (based on the weight of the evidence of risk and the magnitude of risk), including if appropriate, a ban or phase out of the manufacture, processing, or use of the chemical substance in accordance with subparagraph (C). Rules promulgated under this section may apply to mixtures containing the chemical substance, as appropriate. A restriction under subparagraph
(A)may include, as appropriate— a requirement that a chemical substance be marked with, or accompanied by, clear and adequate warnings and instructions with respect to use, distribution in commerce, or disposal, or any combination of those activities, with the form and content of the warnings and instructions to be prescribed by the Administrator; a requirement that manufacturers and processors of the chemical substance— make and retain records of the processes used to manufacture or process the chemical substance; and subject to section 4(f), develop test information that is reasonably necessary to ensure compliance with this Act; a limitation on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce; a requirement to ban or phase out or other regulation on the manufacture, processing, or distribution in commerce of the chemical substance— for a particular use; or for a particular use at a concentration in excess of a level specified by the Administrator; a limitation on the quantity of the chemical substance that may be manufactured, processed, or distributed in commerce— for a particular use; or for a particular use at a concentration in excess of a level specified by the Administrator; a requirement to ban or phase out or other regulation of any method of commercial use of the chemical substance; a requirement to ban or phase out or other regulation of any method of disposal of the chemical substance or any article containing the chemical substance; a requirement directing manufacturers or processors of the chemical substance to give notice of unreasonable risks of harm to distributors in commerce of the chemical substance and, to the extent reasonably ascertainable, to other persons in the chain of commerce in possession of the chemical substance; and such other requirements as the Administrator determines to be necessary. The Administrator shall base a determination under subparagraph
(A)that a ban or phase out of the manufacture, processing, or use of a chemical substance is necessary on the considerations described in subparagraph (D). If the Administrator determines that the chemical substance does not meet the safety standard under the intended conditions of use, the Administrator shall consider and publish a statement on— the availability of technically and economically feasible alternatives for the chemical substance under the intended conditions of use; the risks posed by those alternatives as compared to those of the chemical substance; the economic and social costs and benefits of the proposed regulatory action and options considered, and of potential alternatives; and the economic and social benefits and costs of— the chemical substance; alternatives to the chemical substance; and any necessary restrictions on the chemical substance or alternatives. The Administrator may exempt the use of a chemical substance from any additional restriction established under paragraph
(9)if the Administrator determines that— the exemption is in the interest of national security; the lack of availability of the chemical substance would cause significant disruption in the national economy; the use for which the exemption is sought is a critical or essential use for which— no feasible alternative for the use would materially reduce risk to health or the environment; or no feasible alternative for the use is economically, technically, or efficiently available; or the use, as compared to reasonably available alternatives, provides a net benefit to human health, the environment, or public safety. A safety determination under this subsection shall be— considered to be a final agency action; and subject to judicial review, including review of the associated safety assessment under this subsection. ; by redesignating subsections
(e)and
(f)as subsections
(d)and (e), respectively; and in subsection
(d)(as so redesignated)— by striking paragraph (4); and by redesignating paragraph
(5)as paragraph (4).
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Sec. 6
Safety assessments and determinations
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