158.2000—Biochemical pesticides definition and applicability.
This subpart applies to all biochemical pesticides as defined in paragraphs (a), (b), and (c) of this section.
(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
(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.
(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.
(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.