EPA is announcing a proposed rule that, once finalized, will provide several corrections and clarifications to the microbial pesticides data requirements (40 CFR part 158, subpart V). The rule also solicits comments on a draft test guideline for microbial pesticides. These proposed changes are intended to improve efficiencies and minimize unnecessary burdens for both the regulated industry and the Agency.
The proposed changes to 40 CFR part 158 do not include new regulatory requirements. Rather, the revisions clarify that a new "isolate" of a microbial pesticide would be considered a new active ingredient and not a new "strain," as the latter term has often resulted in confusion within the regulated industry. This proposed rule will address this problem by proposing new regulatory language that clarifies the requirements applicable to new strains that are considered to be new active ingredients under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). The revisions proposed in this rule also include several other minor corrections to words and references.
In addition, EPA is seeking public comment on a new draft microbial pesticide test guideline that companies may use in testing pesticides and chemical substances for submission to the Agency. Test guidelines serve as a compendium of accepted scientific methodologies and protocols that are intended to provide guidance for conducting tests and gathering data that will inform and support regulatory decisions.
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