EPA Method 810 3300

With the exception of confirmatory testing (described under OCSPP guideline 810.2000, section (B)(7)), all studies initiated on or after August 28, 2019 should be in compliance with the 2018 revised guidelines for testing.

The study initiation date is defined under 40 CFR Part 160.3 as the date the protocol is signed by the study director. Studies that were initiated prior to the implementation date but submitted to the Agency for review after the implementation date may use either the previous version of the guidelines (2012) or the revised (2018) versions, as appropriate. The Agency intends to address confirmatory testing through a separate guidance, which will be made available for public comment prior to finalization.

In the interim, applicants should consult with EPA for all confirmatory efficacy questions with the exception of the examples of formulation changes that do not need confirmatory efficacy data, identified in section B(7) of the 810.2000 chapter. This guidance is not binding on EPA or any outside parties, and EPA may depart from the guidance where circumstances warrant and without prior notice. Registrants and applicants may propose and submit alternative practices (e.g., modifications to the recommended test methodology) to the Agency for assessment. The Agency will evaluate any proposed method modifications for appropriateness on a case-by-case basis. This guidance may be updated in the future.