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EPA Releases Frequently Asked Questions for Series 810 Test Guidelines

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.

©2020 Bergeson & Campbell, P.C.

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Lisa Campbell, Bergeson PC, Federal Insecticide Fungicide Rodenticide Act attorney, TSCA lawyer, environmental statutes legal counsel, regulation compliance law
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Lisa Campbell founded Bergeson & Campbell, P.C. (B&C®) with Lynn Bergeson. Today her practice focuses on many aspects of pesticide and chemical regulation. She counsels clients on a wide range of issues pertaining to exposure and risk assessment, risk communication, and related legal and regulatory aspects of pesticide programs under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). She also counsels B&C clients on various chemical-specific programs under the Toxic Substances Control Act (TSCA) as well as chemicals regulation and...

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Healther Collins, Regulatory Consultant, Bergeson and Campbell, health and safety compliance
Regulatory Consultant

Heather F. Collins, M.S., Regulatory Consultant with Bergeson & Campbell, P.C. has nearly two decades of experience developing, implementing, and managing environmental, health, and safety (EH&S) compliance for global chemical and chemical product companies.  Her prodigious skills in developing biocide and pesticide registration and compliance strategies, safety data sheet authoring, and dangerous goods management, coupled with her keen awareness of the financial and temporal pressures of the marketplace make her an excellent resource for clients seeking a competitive edge in their compliance management.  Ms. Collins holds a Masters in Science degree in Environmental Science and Management and a Bachelor of Science in Biology and Biochemistry from Duquesne University.

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