158.2100—Microbial pesticides definition and applicability.

(a) This subpart applies to all living or dead microbial pesticides as described in paragraphs (b) and (c) of this section.
(b) Definition. Microbial pesticide is a microbial agent intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, that:
(1) Is a eucaryotic microorganism including, but not limited to, protozoa, algae, and fungi;
(2) Is a procaryotic microorganism, including, but not limited to, Eubacteria and Archaebacteria; or
(3) Is a parasitically replicating microscopic element, including, but not limited to, viruses.
(c) Applicability. (1) This part applies to microbial pesticides as specified in paragraphs (c)(2), (3) and (4) of this section.
(2) Each new isolate of a microbial pesticide is treated as a new strain and must be registered independently of any similar registered microbial pesticide strain and supported by data required in this subpart.
(3) Genetically modified microbial pesticides may be subject to additional data or information requirements on a case-by-case basis depending on the particular microbial agent and/or its parental strains, the proposed pesticide use pattern, and the manner and extent to which the organism has been genetically modified.
(4) Pest control organisms such as insect predators, nematodes, and macroscopic parasites are exempt from the requirements of FIFRA as authorized by section 25(b) of FIFRA and specified in § 152.20 (a) of this chapter.