Bergeson & Campbell, P.C. serves small, medium, and large pesticide product registrants and other stakeholders in the agricultural and biocidal sectors, in virtually every aspect of pesticide law, policy, science, and regulation.

By Lisa M. Campbell and Heather F. Collins, M.S.

On August 28, 2019, the U.S. Environmental Protection Agency (EPA) released the Frequently Asked Questions (FAQ) web resource for the Series 810 – Product Performance Test Guidelines: Antimicrobial Efficacy Test Guidelines.  As of August 28, 2019, efficacy testing should be in compliance with the following Product Performance Test Guidelines published by EPA in February 2018:

  • 810.2000: General Considerations for Testing Public Health Antimicrobial Pesticides, Guide for Efficacy Testing;
  • 810.2100: Sterilants, Sporicides, and Decontaminants, Guide for Efficacy Testing; and
  • 810.2200: Disinfectants for Use on Environmental Surfaces, Guide for Efficacy Testing.

The guidelines provide recommendations for the design and execution of laboratory studies to evaluate the effectiveness of antimicrobial pesticides against public health microbial pests.  83 Fed. Reg. 8666.  EPA states that these FAQs “provide prompt and transparent guidance to all applicants regarding commonly asked questions concerning the 810 guidelines updated in February 2018.”

With the exception of confirmatory testing (as 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 EPA for review after the implementation date may use either the previous 2012 version of the guidelines or the 2018 revised guidelines, as appropriate. EPA states that it “intends to address confirmatory testing through a separate guidance, which will be made available for public comment prior to finalization.”

The FAQs include general testing questions and questions related to each specific guideline.  The appendices to the FAQs include examples of label use-directions for dilutable products, repeat testing guidance with example scenarios, and sample virucidal calculations.

There has been some concern in the regulated community regarding the need for clarification on the guidelines before they became effective.  EPA’s new FAQs are intended to provide these clarifications, but the timing of their issuance may be of concern to some.  Also of interest is whether additional FAQs will be issued in the future.


 

By Lisa M. Campbell and Lara A. Hall, MS, RQAP-GLP

On August 21, 2018, the U.S. Environmental Protection Agency (EPA) announced it was posting new frequently asked questions (FAQ) for registrants and contract laboratories conducting honeybee toxicity testing.  EPA states that these FAQs are “made up of responses to inquiries EPA commonly receives about protocols used to generate honeybee toxicity data for submission in support of pesticide registration,” and are “meant to complement the Agency’s existing Pollinator Risk Assessment Guidance and increase the transparency and clarity of the risk assessment process.”  The FAQs include general study questions and questions related to specific kinds of contact toxicity, oral toxicity, chronic toxicity, toxicity of residues on foliage, and field and tunnel colony toxicity levels.  Questions not found in the FAQs or risk assessment guidance can be submitted to .(JavaScript must be enabled to view this email address).