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By Barbara A. Christianson and Heather F. Collins, M.S.

On September 24, 2019, the U.S. Environmental Protection Agency (EPA) announced the availability of the premises treatment final test guideline, under Series 810, Product Performance Test Guidelines.  The guideline, 810.3500 Premise Treatment, provides recommendations on how to conduct efficacy testing against invertebrate pests in premises, such as cockroaches, ticks, mosquitoes, flies and wasps in connection with registration of pesticide products for use against public health pests.  This guideline does not, however, apply to efficacy testing for treatment of livestock or pets, wide-area mosquito control, structural protection from termites, or bed bug products.

EPA states that “The final guideline clarifies the original guideline published in 1998 based on public comments and recommendations from the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP).”

Revisions to 810.3500 include

  • Clarifying bait product testing;
  • Offering more flexibility in testing design;
  • Updating the replication recommendations based on statistical modeling and ease of obtaining pests; and
  • Refining the statistical analyses recommendations.

Documents pertaining to the revision of the product performance guidelines, including public comment submissions, and the agency’s response to comments are available at www.regulations.gov in Docket Number EPA-HQ-OPP-2017-0693.  More information on test guidelines is available on our blog.


 

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.