Study means any experiment at one of more test sites, in which a test substance is studied in a test system under laboratory conditions or in the environment to determine or help predict its effects, metabolism, product performance (efficacy studies only as required by 40 CFR 158.400 or 161.640, as applicable), environmental and chemical fate, persistence and residue, or other characteristics in humans, other living organisms, or media. The term studydoes not include basic exploratory studies carried out to determine whether a test substance or a test method has any potential utility.


40 CFR § 160.3

Scoping language

As used in this part the following terms shall have the meanings specified:

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