Sec. 4. Policies, procedures, and guidance
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The Toxic Substances Control Act is amended by inserting after section 3 ( 15 U.S.C. 2602 ) the following: In this section, the term guidance includes any significant written guidance of general applicability prepared by the Administrator. 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 develop, after providing public notice and an opportunity for comment, any policies, procedures, and guidance the Administrator determines to be necessary to carry out sections 4, 4A, 5, and 6, including the policies, procedures, and guidance required by this section.
The Administrator shall establish policies, procedures, and guidance on the use of science in making decisions under sections 4, 4A, 5, and 6. A goal of the policies and procedures described in paragraph
(1)shall be to make the basis of decisions clear to the public. The policies, procedures, and guidance issued under this section shall describe the manner in which the Administrator shall ensure that— decisions made by the Administrator— are based on information, procedures, measures, methods, and models employed in a manner consistent with the best available science; take into account the extent to which— assumptions and methods are clearly and completely described and documented; variability and uncertainty are evaluated and characterized; and the information has been subject to independent verification and peer review; and are based on the weight of the scientific evidence, by which the Administrator considers all information in a systematic and integrative framework to consider the relevance of different information; to the extent practicable and if appropriate, the use of peer review, standardized test design and methods, consistent data evaluation procedures, and good laboratory practices will be encouraged; a clear description of each individual and entity that funded the generation or assessment of information, and the degree of control those individuals and entities had over the generation, assessment, and dissemination of information (including control over the design of the work and the publication of information) is made available; and if appropriate, the recommendations in reports of the National Academy of Sciences that provide advice regarding assessing the hazards, exposures, and risks of chemical substances are considered. The policies, procedures, and guidance described in subsection
(b)shall incorporate, as appropriate, existing relevant hazard, exposure, and risk assessment guidelines and methodologies, data evaluation and quality criteria, testing methodologies, and other relevant guidelines and policies of the Environmental Protection Agency. Not later than 5 years after the date of enactment of this section, and not less frequently than once every 5 years thereafter, the Administrator shall— review the adequacy of any policies, procedures, and guidance developed under this section, including animal, nonanimal, and epidemiological test methods and procedures for assessing and determining risk under this Act; and after providing public notice and an opportunity for comment, revise the policies, procedures, and guidance if necessary to reflect new scientific developments or understandings. In making any decision with respect to a chemical substance under section 4, 4A, 5, or 6, the Administrator shall take into consideration information relating to the hazards and exposures of a chemical substance under the conditions of use that is reasonably available to the Administrator, including information that is— submitted to the Administrator pursuant to any rule, consent agreement, order, or other requirement of this Act, or on a voluntary basis, including pursuant to any request made under this Act, by— manufacturers or processors of a substance; the public; other Federal departments or agencies; or the Governor of a State or a State agency with responsibility for protecting health or the environment; submitted to a governmental entity in any jurisdiction pursuant to a governmental requirement relating to the protection of health or the environment; or identified through an active search by the Administrator of information sources that are publicly available or otherwise accessible by the Administrator. The Administrator shall establish policies and procedures for the testing of chemical substances or mixtures under section 4. A goal of the policies and procedures established under paragraph
(1)shall be to make the basis of decisions clear to the public. The policies and procedures established under paragraph
(1)shall— address how and when the exposure level or exposure potential of a chemical substance would factor into decisions to require new testing, subject to the condition that the Administrator shall not interpret the lack of exposure information as a lack of exposure or exposure potential; describe the manner in which the Administrator will determine that additional information is necessary to carry out this Act, including information relating to potentially exposed or susceptible populations; require the Administrator to consult with the Director of the National Institute for Occupational Safety and Health prior to prescribing epidemiologic studies of employees; and prior to adopting a requirement for testing using vertebrate animals, require the Administrator to take into consideration, as appropriate and to the extent practicable, reasonably available— toxicity information; computational toxicology and bioinformatics; high-throughput screening methods and the prediction models of those methods; and scientifically reliable and relevant alternatives to tests on animals that would provide equivalent information. Except as provided in subparagraph (D), the Administrator shall employ a tiered screening and testing process, under which the results of screening-level tests or assessments of available information inform the decision as to whether 1 or more additional tests are necessary. The screening-level tests required for a chemical substance or mixture may include tests for hazard (which may include in silico, in vitro, and in vivo tests), environmental and biological fate and transport, and measurements or modeling of exposure or exposure potential, as appropriate. Screening-level tests shall be used— to screen chemical substances or mixtures for potential adverse effects; and to inform a decision of the Administrator regarding whether more complex or targeted additional testing is necessary. If the Administrator determines under subparagraph
(B)that additional testing is necessary to provide more definitive information for safety assessments or safety determinations, the Administrator may require more advanced tests for potential health or environmental effects or exposure potential. The Administrator may require more advanced testing without conducting screening-level testing when other information available to the Administrator justifies the advanced testing, pursuant to guidance developed by the Administrator under this section. The Administrator shall inform the public regarding the schedule for the completion of each safety assessment and safety determination as soon as practicable after designation as a high-priority substance pursuant to section 4A. The Administrator may allot different times for different chemical substances in the schedules under this paragraph, subject to the condition that all schedules shall comply with the deadlines established under section 6. At the beginning of each calendar year, the Administrator shall identify the substances subject to safety assessments and safety determinations to be completed that year. The Administrator shall establish, by rule, policies and procedures regarding the manner in which the Administrator shall carry out section 6. A goal of the policies and procedures under this paragraph shall be to make the basis of decisions of the Administrator clear to the public. At a minimum, the policies and procedures under this paragraph shall— describe— the manner in which the Administrator will identify informational needs and seek that information from the public; the information (including draft safety assessments) that may be submitted by interested individuals or entities, including States; and the criteria by which that information will be evaluated; require the Administrator— to define the scope of the safety assessment and safety determination to be conducted under section 6, including the hazards, exposures, conditions of use, and potentially exposed and susceptible populations that the Administrator expects to consider in a safety assessment; to explain the basis for the scope of the safety assessment and safety determination; and to accept comments regarding the scope of the safety assessment and safety determination; and to identify the items described in subclause
(I)that the Administrator has considered in the final safety assessment; and to explain the basis for the consideration of those items; describe the manner in which aggregate exposures, or significant subsets of exposures, to a chemical substance under the conditions of use will be considered, and explain the basis for that consideration in the final safety assessment; require that each safety assessment and safety determination shall include— a description of the weight of the scientific evidence of risk; and a summary of the information regarding the impact on health and the environment of the chemical substance that was used to make the assessment or determination, including, as available, mechanistic, animal toxicity, and epidemiology studies; establish a timely and transparent process for evaluating whether new information submitted or obtained after the date of a final safety assessment or safety determination warrants reconsideration of the safety assessment or safety determination; and when relevant information is provided or otherwise made available to the Administrator, shall consider the extent of Federal regulation under other Federal laws. Not later than 1 year after the date of enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act , the Administrator shall develop guidance to assist interested persons in developing draft safety assessments and other information for submission to the Administrator, which may be considered at the discretion of the Administrator. The guidance shall, at a minimum, address the quality of the information submitted and the process to be followed in developing a draft assessment for consideration by the Administrator. If the Administrator intends to prohibit or otherwise restrict an article on the basis of a chemical substance contained in that article, the Administrator shall have evidence of significant exposure to the chemical substance from such article. Subject to section 14, the Administrator shall— make publicly available a nontechnical summary, and the final version, of each safety assessment and safety determination; provide public notice and an opportunity for comment on each proposed safety assessment and safety determination; and make public in a final safety assessment and safety determination— the list of studies considered by the Administrator in carrying out the safety assessment or safety determination; and the list of policies, procedures, and guidance that were followed in carrying out the safety assessment or safety determination. Not later than 1 year after the date of enactment of this section, the Administrator shall establish an advisory committee, to be known as the Science Advisory Committee on Chemicals (referred to in this subsection as the Committee ). The purpose of the Committee shall be to provide independent advice and expert consultation, on the request of the Administrator, with respect to the scientific and technical aspects of issues relating to the implementation of this title. The Committee shall be composed of representatives of such science, government, labor, public health, public interest, animal protection, industry, and other groups as the Administrator determines to be advisable, including, at a minimum, representatives that have specific scientific expertise in the relationship of chemical exposures to women, children, and other potentially exposed or susceptible populations. The Administrator shall convene the Committee in accordance with such schedule as the Administrator determines to be appropriate, but not less frequently than once every 2 years. All proceedings and meetings of the Committee shall be subject to the Federal Advisory Committee Act (5 U.S.C. App.). .
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Sec. 4
Policies, procedures, and guidance
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