EPA Issues Guidance for "Long-Lasting" Antimicrobial Approval Process

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Guidance Provides Roadmap for Companies Seeking Expedited Review of Products Aimed at Combatting SARS CoV-2

In August, EPA issued a narrowly tailored approval under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) for the first surface disinfectant authorized for longer-lasting effect against the SARS CoV-2 virus that causes COVID-19. At that time, EPA signaled that it was developing guidance to aid future approvals of similar products. Since that time, EPA has been inundated with requests from companies seeking to gain approval for their products aimed at combatting the SARS CoV 2 virus. On October 14, EPA issued new guidance on data and testing requirements required for expedited review of such applications.

WHAT TYPES OF PRODUCTS DOES THE GUIDANCE COVER?

EPA defines two classes of long-lasting disinfectants it will consider for expedited FIFRA approval under the new guidance:

  • Supplemental residual antimicrobial products – Products that stand up to regular cleaning and offer protection for weeks or longer. Examples include films and paint products.
  • Residual disinfectants – Products effective against viruses within 10 minutes where the product’s effectiveness lasts up to 24 hours. Such products must also meet the performance standard for non-residual disinfectants.
WHAT TOOLS DOES EPA OFFER FOR COMPANIES USING THE GUIDANCE?

EPA references specific test protocols to aid in supporting their applications:

  • Residual disinfectants → EPA’s Residual Self-Sanitization Protocol
  • Antimicrobial surface coatings and films → EPA’s Draft Performance of Antimicrobial Surface Coatings on Hard Non-Porous Surfaces
  • Fixed/solid surfaces (including metals), other solid impregnated materials and paints → EPA’s Draft Copper Surface Protocol

The guidance also notes that companies seeking registration of long-lasting products must undertake and submit a durability assessment. EPA has also included information on required label statements for each type of product. Companies applying for supplemental residual antimicrobial product approval must also submit a written product stewardship program for management of these products.

HOW DOES THIS RELATE TO EPA’S “LIST N” OF PRODUCTS APPROVED FOR USE AGAINST SARS COV-2?

Products on List N are effective when used on a surface, but do not claim continuous effectiveness after application. The new guidance addresses requirements for products that claim longer lasting efficacy. Residual disinfectants are eligible for inclusion on List N. EPA will create a List N “appendix” for supplemental residual antimicrobial products.

WHAT DOES EXPEDITED REVIEW MEAN?

EPA does not specify how much faster companies using the guidance will obtain their approvals; rather, the guidance states EPA’s objective of reducing the 4- to 24-month timeline by at least 1-2 months. Given the specifications of the required tests, it remains to be seen whether the new guidance will encourage more companies to seek FIFRA registration or simply adjust the expectations of many would-be applicants. EPA’s sustained attention to enforcement against unregistered products claiming effectiveness against SARS CoV-2 and other viruses and bacteria provides a strong incentive for companies to understand the requirements outlined in this and other EPA guidance and regulations concerning antimicrobial products.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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