§ 158.65 - Biochemical and microbial pesticides.

Biochemical and microbial pesticides are generally distinguished from conventional chemical pesticides by their unique modes of action, low use volume, target species specificity or natural occurrence. In addition, microbial pesticides are living entities capable of survival, growth reproduction and infection. Biochemical and microbial pesticides are subject to a different set of data requirements, as specified in §§ 158.165 and 158.170, respectively.

(a) Biochemical pesticides. Biochemical pesticides include, but are not limited to, products such as semichemicals (e.g. insect pheromones), hormones (e.g., insect juvenile growth hormones), natural plant and insect regulators, and enzymes. When necessary the Agency will evaluate products on an individual basis to determine whether they are biochemical or conventional chemical pesticides.

(b) Microbial pesticides. (1) Microbial pesticides include microbial entities such as bacteria, fungi, viruses, and protozoans. The data requirements apply to all microbial pesticides, including those that are naturally-occurring as well as those that are genetically modified. Each “new” variety, subspecies, or strain of an already registered microbial pest control agent must be evaluated, and may be subject to additional data requirements.

(2) Novel microbial pesticides (i.e., genetically modified or non-indigenous microbial pesticides) will be subject to additional data or information requirements on a case-by-case basis depending on the particular micro-organism, its parent microorganism, the proposed pesticide use pattern, and the manner and extent to which the organism has been genetically modified. Additional requirements may include information on the genetic engineering techniques used, the identity of the inserted or deleted gene segment (base sequence data or enzyme restriction map of the gene), information on the control region of the gene in question, a description of the “new” traits or characteristics that are intended to be expressed, tests to evaluate genetic stability and exchange, and/or selected Tier II environmental expression and toxicology tests.

(3) 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.