Health and safety study

Health and safety study or study means any study of any effect of a substitute or its components on health and safety, or the environment or both, including underlying data and epidemiological studies, studies of occupational, ambient, and consumer exposure to a substitute, toxicological, clinical, and ecological, or other studies of a substitute and its components, and any other pertinent test. Chemical identity is always part of a health and safety study. Information which arises as a result of a formal, disciplined study is included in the definition. Also included is information relating to the effects of a substitute or its components on health or the environment. Any available data that bear on the effects of a substitute or its components on health or the environment would be included. Examples include:
(1) Long- and short-term tests of mutagenicity, carcinogenicity, or teratogenicity; data on behavioral disorders; dermatoxicity; pharmacological effects; mammalian absorption, distribution, metabolism, and excretion; cumulative, additive, and synergistic effects; acute, subchronic, and chronic effects; and structure/activity analyses;
(2) Tests for ecological or other environmental effects on invertebrates, fish, or other animals, and plants, including: Acute toxicity tests, chronic toxicity tests, critical life stage tests, behavioral tests, algal growth tests, seed germination tests, microbial function tests, bioconcentration or bioaccumulation tests, and model ecosystem (microcosm) studies;
(3) Assessments of human and environmental exposure, including workplace exposure, and effects of a particular substitute on the environment, including surveys, tests, and studies of: Biological, photochemical, and chemical degradation; air, water and soil transport; biomagnification and bioconcentration; and chemical and physical properties, e.g., atmospheric lifetime, boiling point, vapor pressure, evaporation rates from soil and water, octanol/water partition coefficient, and water solubility;
(4) Monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a substitute; and
(5) Any assessments of risk to health or the environment resulting from the manufacture, processing, distribution in commerce, use, or disposal of the substitute or its components.


40 CFR § 82.172

Scoping language

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