Sec. 4. Chemical assessment framework; prioritization screening; testing
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Section 4 (15 U.S.C. 2603) is amended— in the heading, by striking and inserting Testing of chemical substances and mixtures . Chemical assessment framework; prioritization screening; testing by redesignating subsection
(e)as subsection (l); in subsection
(l)(as so redesignated)— by striking rule each place it appears and inserting rule, testing consent agreement, or order ; by striking under subsection
(a)each place it appears and inserting under this subsection ; and in paragraph (1)(B), by striking rulemaking ; and by striking subsections
(a)through (d), (f), and
(g)and inserting the following: The Administrator shall develop a framework in accordance with subsection
(e)and sections 5 and 6 for evaluating the safety of chemical substances in commerce that shall employ the best available science and risk assessment principles in existence at the time the Administrator is developing the framework. After the date of enactment of the Chemical Safety Improvement Act , the Administrator shall promptly develop appropriate policies and procedures for implementing the framework, including procedures on the collection, evaluation, and development of data and information. The policies and procedures shall require— the collection of existing data and information from manufacturers and processors of chemical substances and other sources, including the use of voluntary agreements to provide the data and information; an evaluation of the quality of existing data and information; an analysis of data and information; a determination of the need for additional data and information, including information related to the exposures of different subpopulations; and subject to section 14, transparency of data and information considered by the Administrator, including both positive and negative findings. The Administrator shall ensure that the evaluation framework described in subsection (a)(1)— is transparent; assures that data and information are valid; addresses the strengths and limitations of— the design of the framework, the reliability of the test methods; and the quality of the data and information; and pursues the goal of maximizing the quality, objectivity, utility, and integrity of the data and information. The Administrator shall establish and publish scientifically sound criteria for evaluating all of the data and information, including the results of animal and nonanimal testing, regardless of affiliation or funding source, on which the Administrator relies in making a decision under this Act. The Administrator shall require that the submitter of any health and safety study disclose to the Administrator and to the public the sources of any funding used for the study or publication of the study received by the researcher who conducted the study, to the extent reasonably ascertainable. For test data developed under this Act, the Administrator shall encourage the use of good laboratory practices, peer review, scientifically reliable and relevant test methods, standardized protocols, and other methods to ensure scientific quality for all data and information submitted under this Act. Nothing in this subsection shall preclude the Administrator from considering data and information which do not meet the quality criteria established under paragraph (1). The Administrator shall— identify any data and information described in subparagraph
(A)on which the Administrator relies; describe the quality of the data and information described in subparagraph
(A)and the extent to which the data and information depart from those criteria; indicate any limitations on the usefulness of the data and information described in subparagraph (A); and explain how the data and information described in subparagraph
(A)was used and the basis for reliance on the data and information. The Administrator shall develop and use a structured evaluative framework consisting of science-based criteria, consistent with the protection of human health and the environment, for making any decision under this Act, and for determining the relevance, quality, and reliability of data and information. The framework described in subparagraph
(A)shall, at a minimum— use sound and objective scientific practices in assessing risks; consider the current best available science (including peer-reviewed studies); when consistent with the underlying data, consider, for both cancer and noncancer endpoints, whether available data support or do not support the identification of threshold doses of a chemical substance below which no adverse effects can be expected to occur; and include a description of the weight of the scientific evidence concerning risks, including mechanistic information (such as appropriate modes of action). In making any decision with respect to a chemical substance under subsection
(e)and sections 5 and 6, the Administrator shall consider data and information relevant to the substance that are reasonably available to the Administrator at that time, including data and information that are— submitted to the Administrator by— manufacturers and processors of the substance; the public; or a Governor of a State or a State agency with responsibility for protecting health or the environment; submitted to a governmental body in another jurisdiction under a governmental requirement relating to the protection of human health and the environment, if the information is accessible to the Administrator; derived through the application of scientifically reliable and relevant structure-activity relationship, or other methods or models to estimate the environmental and human health effects, environmental and biological fate and behavior, and exposure potential for the substance; inferred based on the degree of structural similarity or properties of the substance, or categories of substances, 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 for the chemical substance; and identified through an active search by the Administrator of information sources that are publicly available or otherwise accessible to the Administrator. Subject to section 14, the data and information considered by the Administrator in taking action under this Act shall be available to the public. The Administrator shall make available to the public the guidance, procedures, and tools used in evaluating data and information under this section, including models, studies, and, as appropriate, the data underlying any study. Any written guidance of general applicability prepared by the Administrator under this Act shall be subject to public notice and an opportunity for comment. Not later than 1 year after the date of enactment of the Chemical Safety Improvement Act , the Administrator shall establish a risk-based screening process for identifying existing chemical substances that are— a high priority for a safety assessment and determination under section 6, to be known as high-priority substances ; and a low priority for a safety assessment and determination, to be known as low-priority substances . In implementing the process described in subparagraph (A), the Administrator shall only consider active substances, as determined under section 8(b)(6), as either high-priority substances or low-priority substances. In implementing the process described in subparagraph (A), the Administrator shall only consider inactive substances, as determined under section 8(b)(7), that the Administrator determines, on the basis of credible scientific evidence that— have not been subject to a regulatory or other enforceable action by the Administrator to ban or phase out the substances; and demonstrate high hazard and high exposure. The Administrator shall make every effort to complete the prioritization of all active substances in a timely manner. The Administrator shall prioritize substances taking into consideration the ability of the Administrator to schedule and complete safety assessments and determinations under section 6 in a timely manner. In making a decision under the prioritization screening process, the Administrator shall use reasonably available data and information concerning the hazard, exposure, and use characteristics of chemical substances on the list developed by the Administrator under section 8(b)(1) at the time the decision is made. The Administrator may screen categories or classes of chemical substances to ensure an efficient prioritization screening process to allow for timely and adequate safety assessments and determinations. From time to time the Administrator shall— publish a list of chemical substances being considered in the prioritization screening process; and request the submission of data and information on the chemical substances. The Administrator shall— publish for public comment a proposed prioritization screening process; and establish criteria for determining whether a substance is a high or low priority for a safety assessment and determination. The proposal shall include an initial list of chemical substances that includes, at a minimum, those substances prioritized by the Administrator before the date of enactment of the Chemical Safety Improvement Act and for which assessments or safety determinations have not been completed, and proposed prioritization outcomes based on the proposed criteria. The initial list shall contain as many chemical substances as the Administrator determines appropriate. The Administrator may modify the initial list on the basis of comments received on the proposed process and criteria. The criteria described in subparagraph
(A)shall consider— the recommendation of a Governor of a State or a State agency with responsibility for protecting health or the environment from chemical substances appropriate for prioritization screening; the hazard and exposure potential of the chemical substance (or category or class of substances), including specific scientific classifications and designations by authoritative governmental entities; the intended conditions of use or significant changes in the conditions of use of the chemical substance; evidence and indicators of exposure potential to humans or the environment from the chemical substance; the volume of a chemical substance manufactured or processed; whether the volume of a chemical substance as reported under a regulation issued under section 8(a) (as in effect on the date on which the criteria are proposed) has significantly increased or decreased since a previous report or since the date on which a notice has been submitted under section 5(a); the availability of information about potential hazards and exposures needed for conducting a safety assessment or determination, with limited availability of relevant data and information to be a factor in designating a substance as a high priority; and the extent of Federal or State regulation of the chemical substance or the extent of the impact of State regulation of the chemical substance on the United States, with existing Federal or State regulation of any uses evaluated in the prioritization screening process as a factor in designating a chemical substance to be a low priority. For the chemical substances considered for prioritization screening, the Administrator shall apply the criteria identified in paragraph (2), using the information identified in subsection (c), to identify a chemical substance as a high-priority substance or a low-priority substance. If the Administrator determines that additional test data and information are needed to establish the priority of a chemical substance, the Administrator shall provide an opportunity for interested persons to submit data and information to the extent that it is reasonably ascertainable. If the Administrator determines that it is appropriate, the Administrator may defer a prioritization screening decision for a chemical substance under subparagraph
(A)for a reasonable period to allow for the submission and evaluation of additional data and information. During the prioritization screening of a chemical substance, the Administrator shall integrate any hazard and exposure data and information related to a chemical substance available to the Administrator. The Administrator— shall identify as a high-priority substance a chemical substance that, relative to other substances, has the potential for high hazard and high exposure; may identify as a high-priority substance a chemical substance that, relative to other substances, has the potential for high hazard or high exposure; and may identify as a high-priority substance an inactive substance, as determined under section 8(b)(7), that the Administrator determines, on the basis of credible scientific evidence that— has not been subject to a regulatory action by the Administrator to ban or phase out the substance; and demonstrates high hazard and high exposure. The Administrator shall identify as a low-priority substance a chemical substance that the Administrator on the basis of the available information determines is likely to meet the safety standard under the intended conditions of use. The identifications made under subparagraphs
(E)and
(F)shall be subject to notice and an opportunity for comment. The Administrator— shall determine the order for performing safety assessments on high-priority substances under section 6; and may revise the order as the Administrator determines appropriate. The Administrator shall not perform safety assessments on low-priority substances, unless a low-priority substance is redesignated under subparagraph (I). Subject to subparagraph (D), at any time the Administrator may revise the identification of a chemical substance as a high-priority substance or a low-priority substance based on consideration of data or information made available to the Administrator after the date on which the Administrator makes the identification under subparagraphs
(E)and (F). The Administrator shall evaluate the data or information described in clause
(i)on a high-priority substance or a low-priority substance for possible reevaluation of the priority of the substance. If limited availability of relevant data and information was a factor in the original identification of a chemical substance as a high-priority substance, the Administrator shall reevaluate the prioritization screening of the substance on receiving the relevant data and information. The Administrator shall publish and keep current a list of high-priority substances and a list of low-priority substances. Whenever the Administrator places a chemical substance on one of the lists described in clause
(i)or changes the priority of the chemical substance, the Administrator shall include a justification for the decision in accordance with paragraph (2)(C). The Administrator shall remove a chemical substance from the list of high-priority substances on the date on which a safety determination for the chemical substance is published. Subject to section 18, a decision by the Administrator under this paragraph with respect to a chemical substance shall not affect the manufacture, processing, distribution, use, or disposal of the chemical substance, or regulation of those activities. Not later than 180 days after the date on which the Administrator receives a recommendation and relevant data and information from a Governor of a State or a State agency with responsibility for protecting health and the environment that an active chemical substance be identified as a high-priority or low-priority substance, the Administrator shall make a prioritization screening decision for the substance. The public shall be provided notice and an opportunity to comment on the recommendation described in subparagraph (A). The Administrator shall— make available to the Governor or the appropriate State agency, as applicable, and to the public a brief explanation of reasons for identifying a chemical substance recommended by the Governor or the agency for prioritization screening as either a high-priority substance or a low-priority substance; and identify the information relied upon in making that identification. Any action by the Administrator under this subsection shall not be— considered to be a final agency action; or subject to judicial review. The Administrator may require the development of new test data and information related to a chemical substance or mixture in accordance with this section if the Administration determines that the data and information are needed— to perform a safety assessment; to make a safety determination; or to meet the testing needs of the implementing authority under another Federal statute. The Administrator may require the development of test data and information described in paragraph
(1)by— promulgating a rule; entering into a testing consent agreement; or issuing an order. In promulgating a rule, adopting a testing consent agreement, or issuing an order described in paragraph (2), the Administrator shall require the use of— an evaluation framework that, prior to requiring additional testing of vertebrate animals, integrates relevant information from multiple sources, including, to the extent reliable— toxicity information; computational toxicology; bioinformatics; high-throughput screening methods; and scientifically reliable and relevant alternatives to vertebrate animal tests; and tiered testing in accordance with subsection (h), wherein the results of a screening level tier of tests relating to a toxicity pathway or target organ or target system inform the decision of the Administrator as to whether tests from a higher tier related to that pathway or organ or system are necessary. The Administrator shall explain the basis for a decision made in subparagraph (A)(ii) in a statement made available to the public. A rule, testing consent agreement, or order issued under paragraph
(2)shall include— identification of the chemical substance or mixture for which testing is required; identification of the persons required to conduct the testing; procedures for the development of test data and information for the chemical substance or mixture, including specific reference to reliable nonanimal test procedures; and specification of the period within which persons required to conduct the testing shall submit to the Administrator test data and information developed in accordance with the procedures described in clause (iii). The period described in subparagraph (A)(iv) shall not be of an unreasonable duration. In determining the procedures and period to be required under subparagraph (A), the Administrator shall consider— the relative costs of the various test protocols and methodologies that may be required; and the reasonably foreseeable availability of facilities and personnel needed to perform the testing. In promulgating a rule, entering into a testing consent agreement, or issuing an order for development of additional data and information (including information on exposure or exposure potential) under subsection (f)(2), the Administrator shall issue a statement— identifying the need intended to be met by the rule, agreement, or order; explaining why existing data and information reasonably available to the Administrator at that time are inadequate to meet that need; and encouraging, to the extent possible, the use of nonanimal test methods to develop additional data and information. If the Administrator issues an order, the statement described in paragraph
(1)shall explain why good cause exists for issuance of an order instead of promulgating a rule or entering into a testing consent agreement. A statement described in subparagraph
(A)shall contain a discussion of— data and information that are readily accessible to the Administrator, including data and information submitted under any other provision of law; the extent to which the Administrator has obtained or attempted to obtain the data and information through voluntary submissions; the extent to which the Administrator may use available data and information for structurally related substances (grouping or read-across), or use valid structure-activity relationship models or nonanimal test alternatives; and safety assessments, and the data and information relied on in the assessments, on other chemical substances to the extent relevant to the chemical substances that would be the subject of the rule or order. The Administrator shall develop an evidence-based review system for conducting consistent evaluations of the relevance and reliability of studies of chemical substances and their exposure (including exposure pathways), and a structured evaluative framework to provide a systematic and transparent approach for assessing the overall weight of the evidence for observed biological or other effects, mechanistic information, and exposure. Subject to subsections
(b)and (c), the framework shall have 2 tiers. Tier 1 shall include both a screening level exposure assessment, including modeling if appropriate, and screening tests for hazard. Screening tests for hazard (which may include, as appropriate, scientifically reliable and relevant in silico, in vitro, and focused in vivo tests) and exposure information and modeling shall be used— to screen chemical substances or mixtures for major toxic effects (including acute toxicity, subchronic toxicity, chronic toxicity, carcinogenicity, genotoxicity, developmental toxicity, and neurotoxicity); and to direct planning for more complex and targeted testing in tier 2, if necessary. If the Administrator determines that additional testing is necessary, based on the results of tier 1 testing and modeling and any other available relevant information, tier 2 shall include— an exposure assessment and tests for specific endpoints triggered on the basis of biologically based decisions; and an assessment of potential exposure using scientifically valid approaches. The Administrator shall prepare guidance for implementing this subsection and review that guidance not less than once every 5 years thereafter. The Administrator shall minimize the use of animals in testing of chemical substances or mixtures, including by— encouraging and facilitating, to the maximum extent practicable— the use of integrated and tiered testing and assessment strategies; the use of data and information of sufficient scientific quality in existence on the date on which the test is conducted; the use of test methods that eliminate or reduce the use of animals while providing test data and information of high scientific quality; the grouping of 2 or more chemical substances into scientifically appropriate categories in cases in which testing of a chemical substance would provide reliable and useful test data and information on others in the category; the formation of industry consortia to jointly conduct testing to avoid unnecessary duplication of tests; the submission of test data and information from animal-based studies and from emerging methods and models; and the use of exposure potential as a factor in decisions to require new testing; and funding research and validation studies to reduce, refine, and replace the use of animal tests in accordance with this subsection. To promote the development and timely incorporation of new testing methods that are not laboratory animal-based, the Administrator shall— after providing an opportunity for public comment, develop a strategic plan to promote the development and implementation of alternative test methods and testing strategies to generate information used for any safety-standard determination made that reduce, refine, or replace the use of laboratory animals, including toxicity pathway-based risk assessment, in vitro studies, systems biology, computational toxicology, bioinformatics, and high-throughput screening; beginning on the date that is 5 years after the date of enactment of the Chemical Safety Improvement Act and every 5 years thereafter, submit to Congress a report that describes the progress made in implementing this section; and fund and carry out research, development, performance assessment, and translational studies to accelerate the development of test methods and testing strategies that reduce, refine, or replace the use of laboratory animals in any safety-standard determination made under this section. On request from a manufacturer or processor that is required to conduct animal-based testing of a chemical substance or mixture under this title, the Administrator may adapt or waive the animal-testing requirement if the Administrator determines that— there is sufficient evidence from several independent sources of information to support a conclusion that a chemical substance or mixture has, or does not have, a particular property if the information from each individual source alone is insufficient to support the conclusion; because of one or more physical or chemical properties of the chemical substance or mixture or other toxicokinetic considerations— the material cannot be absorbed; or testing for a specific endpoint is technically not practicable to conduct; or a chemical substance or mixture cannot be tested in animals at concentrations that do not result in significant pain or distress, because of physical or chemical properties of the chemical substance or mixture, such as a potential to cause severe corrosion or severe irritation to the tissues of the animal. The Administrator may require the following persons to develop test data and information: Manufacturers and processors of the chemical substance or mixture identified in subsection (f)(4)(A)(i). Persons who begin to manufacture or process such chemical substance or mixture— after the effective date of the rule, testing consent agreement, or order; but subject to subparagraph (C), before the period ending 180 days after the end of the period identified in subsection (f)(4)(A)(iv). The Administrator may permit 2 or more of the persons identified in subparagraph
(A)to designate a person or a qualified third party— to develop the data and information; and to submit the data and information on behalf of the persons making the designation. A person otherwise subject to a rule, testing consent agreement, or order under subsection
(f)may submit to the Administrator an application for an exemption on the basis that the data and information are being developed by a person designated under subparagraph (B). If the Administrator accepts an application submitted under clause (i), the Administrator shall direct the applicant to provide to the person designated under subparagraph
(B)fair and equitable reimbursement, as agreed to between the applicant and the person designated. If the applicant and a person designated under subparagraph
(B)cannot reach agreement on the amount of fair and equitable reimbursement, the amount shall be determined by arbitration. If, after granting an exemption under this subparagraph, the Administrator determines that no person has complied with the rule, testing consent agreement, or order, the Administrator shall— by order terminate the exemption; and notify in writing each person who received an exemption of the requirements with respect to which the exemption was granted. The Administrator may prescribe guidelines for the development of test data and information under subsection
(f)for health and environmental information, including— test data pertaining to acute toxicity, subchronic toxicity, chronic toxicity, carcinogenicity, genotoxicity, developmental toxicity, and neurotoxicity that may be indicative of an adverse effect; test data and information pertaining to exposure to the chemical substance or mixture, including information regarding bioaccumulation, persistence, and the presence of the chemical substance or mixture in human blood, fluids, or tissue; and information pertaining to aggregate exposure, or other effects that may be considered in a safety assessment. The Administrator— may prescribe methodologies in guidelines for the development of data and information; and shall encourage the use of nonanimal methodologies. The Administrator may develop guidelines for evaluating data from biomonitoring studies. Prior to prescribing epidemiologic studies of employees, the Administrator shall coordinate with the Director of the National Institute for Occupational Safety and Health. Periodically, but not less frequently than once every 5 years, the Administrator shall— review the adequacy of the guidelines for development of data and information prescribed under subparagraph (B); if necessary, institute proceedings to make appropriate revisions of the guidelines; and revise the guidelines as appropriate, particularly to— reflect the availability of scientifically reliable and relevant nonanimal test methods; and eliminate obsolete methodologies that do not produce reliable and relevant results. Subject to section 14, the Administrator shall make available to the public all testing consent agreements and orders and all data and information submitted under this section. . Section 104(i)(5)(A) of the Comprehensive Environmental Response, Compensation, and Liability Act of 1980 (42 U.S.C. 9604(i)(5)(A)) is amended by striking section 4(e) and inserting section 4(l) .
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