Product performance data must be developed for all biochemical pesticides. However, the Agency typically does not require applicants to submit such efficacy data unless the pesticide product bears a claim to control public health pests, such as pest microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates (including but not limited to: rodents, birds, bats, canids, and skunks) or invertebrates (including but not limited to: mosquitoes and ticks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that his products are efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed for registration.
40 CFR § 158.2070
Biochemical pesticides product performance data requirements
June 9, 2020