This subpart applies to all biochemical pesticides as defined in paragraphs (a), (b), and (c) of this section.
(a) Definitions. The following terms are defined for the purposes of subpart U of this part.
(1) A biochemical pesticide is a pesticide that:
(i) Is a naturally-occurring substance or structurally-similar and functionally identical to a naturally-occurring substance;
(ii) Has a history of exposure to humans and the environment demonstrating minimal toxicity, or in the case of a synthetically-derived biochemical pesticides, is equivalent to a naturally-occurring substance that has such a history; and
(iii) Has a non-toxic mode of action to the target pest(s).
(2) A Pheromone is a compound produced by a living organism or is a synthetically derived substance that is structurally similar and functionally identical to a naturally-occurring pheromone, which, alone or in combination with other such compounds, modifies the behavior of other individuals of the same species.
(i) An Arthropod Pheromone is a pheromone produced by a member of the taxonomic phylum Arthropoda.
(ii) A Lepidopteran Pheromone is an arthropod pheromone produced by a member of the insect order Lepidoptera.
(iii) A Straight Chain Lepidopteran Pheromone is a lepidopteran pheromone consisting of an unbranched aliphatic chain (between 9 and 18 carbons) ending in an alcohol, aldehyde, or acetate functional group and containing up to three double bonds in the aliphatic backbone.
(b) Examples. Biochemical pesticides include, but are not limited to:
(1) Semiochemicals (insect pheromones and kairomones),
(2) Natural plant and insect regulators,
(3) Naturally-occurring repellents and attractants, and
(4) Enzymes.
(c) Applicability. The Agency may review, on a case-by-case basis, naturally-occurring pesticides that do not clearly meet the definition of a biochemical pesticide in an effort to ensure, to the greatest extent possible, that only the minimum testing sufficient to make scientifically sound regulatory decisions would be conducted. The Agency will review applications for registration of naturally-occurring pesticides to determine whether to review the pesticide under this subpart U.