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

On April 15, 2022, the U.S. Environmental Protection Agency (EPA) announced final product performance data requirements for products claiming efficacy against certain pests. 87 Fed. Reg. 22464. This action officially incorporates EPA’s already existing product performance standards requirements for certain invertebrate pests into the Code of Federal Regulations (CFR).  EPA states this action also increases the efficiency of its approval process and will save registrants time and money.

Product performance standards are intended to make it easier for pesticide registrants to know the efficacy data that EPA requires to demonstrate that a pesticide product works as claimed. By adding these requirements into the CFR, EPA states that it intends to help ensure that submitted data meet EPA’s needs and scientific standards and satisfy a requirement of the 2018 Pesticide Registration Improvement Extension Act (PRIA 4). EPA notes as part of the agreement between pesticide stakeholders and public interest groups reflecting the environmental and farmworker safety communities in the development of PRIA, “PRIA 4 specifically establishes a new maintenance fee set-aside of up to $500,000/year to develop and finalize rulemaking and guidance for product performance data requirements for certain invertebrate pests of significant public health or economic importance. Specific to this rule, PRIA 4 requires EPA to finalize product performance data requirements by September 30, 2021, for certain pesticides intended for preventing, destroying, repelling, or mitigating specified invertebrate pest of significant public health or economic importance.”

This final rule includes product performance data requirements for the categories of invertebrate pests specified in PRIA 4, which EPA states it intends to satisfy the rulemaking requirement. EPA notes that this final rule covers some invertebrate pests in addition to those specified in PRIA 4 due to their public health, economic, or ecological significance (e.g., wood destroying insects).

EPA states that it believes this final rule will save registrants approximately $17,000 per data package submitted to EPA by reducing waste and unnecessary testing, and believes it will reduce burden hours by 4,683 annually, including 4,515 hours from reduced paperwork burden associated with data generation and 168 hours from reduced paperwork with the application process.

This final rule codifies product performance data requirements to support registration of products claiming efficacy against three categories of invertebrate pests: 

  • Those identified to be of significant public health importance (e.g., ticks, mosquitoes, cockroaches);
  • Wood-destroying insects (e.g., termites); and
  • Certain invasive invertebrate species (e.g., Asian long-horned beetle).

EPA states that the latter two categories are pests considered to be of significant economic or ecological importance.

The final rule is effective on June 14, 2022.

Commentary

Codifying the product performance data requirements for invertebrate pests should increase transparency to registrants regarding the efficacy data that they typically would need to generate and submit for products to make labeling claims against these specific pests. Registrants of the products at issue should monitor these requirements closely.


 

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.