(a) For the purposes of this section, the viral insecticide must be produced with an unaltered and unadulterated inoculum of the single-embedded Heliothis zea nuclear polyhedrosis virus (HzSNPV). The identity of the seed virus must be assured by periodic checks.

(b) Each lot of active ingredient of the viral insecticide shall have the following specifications:

(1) The level of extraneous bacterial contamination of the final unformulated viral insecticide should not exceed 10 7 colonies per gram as determined by an aerobic plate on trypticase soy agar.

(2) Human pathogens, e.g., Salmonella, Shigella, or Vibrio, must be absent.

(3) Safety to mice as determined by an intraperitoneal injection study must be demonstrated.

(4) Identity of the viral product, as determined by the most sensitive and standardized analytical technique, e.g., restriction endonuclease and/or SDS-PAGE analysis, must be demonstrated.

(c) Exemptions from the requirement of a tolerance are established for the residues of the microbial insecticide Heliothis zea NPV, as specified in paragraphs (a) and (b) of this section, in or on all agricultural commodities.

[60 FR 42460, Aug. 16, 1995, as amended at 74 FR 26534, June 3, 2009]