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[Editor’s Note: This section is revised effective July, 2, 2024][New Text]
All definitions in TSCA apply to this subpart. In addition, the following definitions apply:
Act means the Toxic Substances Control Act, as amended (15 U.S.C. 2601 et seq.).
Aggregate exposure means the combined exposures to an individual from a single chemical substance across multiple routes and across multiple pathways.
Best available science means science that is reliable and unbiased. Use of best available science involves the use of supporting studies conducted in accordance with sound and objective science practices, including, when available, peer reviewed science and supporting studies and data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data). Additionally, EPA will consider as applicable:
(1) The extent to which the scientific information, technical procedures, measures, methods, protocols, methodologies, or models employed to generate the information are reasonable for and consistent with the intended use of the information;
(2) The extent to which the information is relevant for the Administrator's use in making a decision about a chemical substance or mixture;
(3) The degree of clarity and completeness with which the data, assumptions, methods, quality assurance, and analyses employed to generate the information are documented;
(4) The extent to which the variability and uncertainty in the information, or in the procedures, measures, methods, protocols, methodologies, or models, are evaluated and characterized; and
(5) The extent of independent verification or peer review of the information or of the procedures, measures, methods, protocols, methodologies or models.
Conditions of use means the circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of.
EPA means the U.S. Environmental Protection Agency.
Pathways means the mode through which one is exposed to a chemical substance, including but not limited to: Food, water, soil, and air.
Potentially exposed or susceptible subpopulation means a group of individuals within the general population identified by the Agency who, due to either greater susceptibility or greater exposure, may be at greater risk than the general population of adverse health effects from exposure to a chemical substance or mixture, such as infants, children, pregnant women, workers, or the elderly.
Reasonably available information means information that EPA possesses or can reasonably generate, obtain, and synthesize for use in risk evaluations, considering the deadlines specified in TSCA section 6(b)(4)(G) for completing such evaluation. Information that meets the terms of the preceding sentence is reasonably available information whether or not the information is confidential business information, that is protected from public disclosure under TSCA section 14.
Routes means the particular manner by which a chemical substance may contact the body, including absorption via ingestion, inhalation, or dermally (integument).
Sentinel exposure means the exposure from a single chemical substance that represents the plausible upper bound of exposure relative to all other exposures within a broad category of similar or related exposures.
Uncertainty means the imperfect knowledge or lack of precise knowledge of the real world either for specific values of interest or in the description of the system.
Variability means the inherent natural variation, diversity, and heterogeneity across time and/or space or among individuals within a population.
Weight of scientific evidence means a systematic review method, applied in a manner suited to the nature of the evidence or decision, that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently, identify and evaluate each stream of evidence, including strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance.
[82 FR 33748, July 20, 2017; 89 FR 37052, May 3, 2024]