This week, the Environmental Protection Agency (EPA) released interim guidance enabling companies to pursue expedited federal review of antimicrobial products’ long-lasting or “residual” effectiveness against pathogens including SARS-CoV-2, the coronavirus responsible for the COVID-19 pandemic.
Companies can begin to apply this interim guidance to their EPA product registration submissions immediately. Pursuant to this guidance, the EPA intends for regulatory decisions on registration and amended registration for eligible products to be issued at least one or two months faster than the typical timeframe under the Pesticide Registration Improvement Act (PRIA).
Two kinds of products are eligible for the EPA’s expedited review: residual disinfectants and supplemental residual antimicrobial products. Residual disinfectants are disinfectants that work within 10 minutes of a virus or bacteria contacting a surface and that are effective for up to 24 hours. By contrast, supplemental residual antimicrobial products are products such as coatings and other surface treatments meant to complement – but not replace – regular cleaning and disinfection. These supplemental products work within two hours of a virus or bacteria contacting a surface and offer antimicrobial protection lasting weeks or even years.
The interim guidance provides performance standards and efficacy testing requirements for each of these products. The guidance also establishes certain requirements for product labeling and for the submission of product registration information. Companies seeking to take advantage of the expedited review process must carefully follow all aspects of the guidance. Registration applications that do not fully conform to the guidance may be made subject to the longer, otherwise-applicable PRIA timeframe for EPA review.
The EPA has also released an interim testing protocol for evaluating a copper surface’s ability to kill bacteria. The copper protocol applies to hard, nonporous solid copper products, impregnated copper products, and copper-coated products and includes such products that make claims for “continuous reduction of bacteria.” Additionally, the EPA released an interim protocol for evaluating the efficacy of antimicrobial surface coatings that provide residual antimicrobial activity for weeks and supplement standard disinfection practices.
The EPA’s guidance is not final, however, and could be rolled back or expanded based on comments the EPA receives from the public over the next 60 days. Companies interested in taking advantage of the process provided by the interim guidance should consider submitting comments in support of finalizing the guidance. Many companies will find that their products have been left out because presently the interim guidance establishes just two product categories eligible for expedited review and provides limited examples of the acceptable product labeling language. Companies that manufacture, import, or distribute products with long-lasting antimicrobial properties that are not clearly included should consider submitting comments that support expanding the guidance. The public comment window presents the best opportunity for interested parties to request additional clarity from the EPA and to ask that product categories and proposed labeling language be diversified. With decades of experience submitting and evaluating comments on EPA actions, our environmental team can help ensure your voice is heard by the EPA.
Alston & Bird has an extensive disinfectant and antimicrobial practice and will continue monitoring the implementation and further development of the EPA’s guidance for existing and new products effective against SARS-CoV-2.
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