On Tuesday, March 3, the U. S. Environmental Protection Agency (EPA) released a list of antimicrobial disinfectant products that are currently approved to make limited efficacy claims against SARS-CoV-2, the coronavirus that causes COVID-19. The exact claims that can be made, and where they can be made, are specifically governed by EPA’s 2016 Emerging Viral Pathogen guidance, which the agency activated on January 29 for SARS-CoV-2/COVID-19. EPA’s authority over pesticide claims and products is derived from the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Here are the five key takeaways regarding EPA’s ongoing efforts to evaluate what antimicrobial pesticide registrants can and cannot say about killing the SARS-CoV-2 virus.
1.EPA limits what claims can be made. Registrant claims are restricted to one of two prepared statements:
i) [Product name] has demonstrated effectiveness against viruses similar to [name of emerging virus] on hard, [porous and/or non-porous surfaces]. Therefore, [product name] can be used against [name of emerging virus] when used in accordance with the directions for use against [name of supporting virus(es)] on [hard, porous/non-porous surfaces]. Refer to the [Centers for Disease Control (CDC) or World Organization for Animal Health (OIE)] website at [pathogen-specific website address] for additional information.
ii) [Name of illness/outbreak] is caused by [name of emerging virus]. [Product name] kills similar viruses and therefore, can be used against [name of emerging virus] when used in accordance with the directions for use against [name of supporting virus(es)] on [hard, porous/non-porous surfaces]. Refer to the [CDC or OIE] website at [website address] for additional information.
2. EPA limits where claims can be made. Registrants can place the above language in the following media: technical literature distributed exclusively to health care facilities, physicians, nurses or public health officials; “1-800” consumer information services; social media sites; and company websites (non-label-related). The above language should not appear on product packaging or onproduct labels. Registrants or distributors should remove these claims from their web materials no later than two years after the original pathogen outbreak notification from CDC or OIE, unless EPA provides guidance to the contrary.
3.This is a “living list.” EPA says that it will continue updating the list of products as more antimicrobial registrants demonstrate that they meet the criteria specified in EPA’s Emerging Viral Pathogen guidance. In the interim, antimicrobial products that are claiming effectiveness against SARS-CoV-2 and do not meet the criteria to be added to this list are likely in violation of FIFRA. To claim effectiveness against SARS-CoV-2, a registrant must have already submitted, through a label amendment or during registration of a new product data showing effectiveness against a future viral emerging pathogen. See No. 4 below for additional details on this process.
4.This may be the time to consider “Emerging Viral Pathogen” approvals for the future. Making allowable claims specific to SARS-CoV-2, or other emerging pathogens, is a two-step process.
The first step starts before a pathogen outbreak. It requires the registrant to submit data to EPA for review and approval, which can be done through a label amendment or when seeking approval of a new product. In the second step, EPA determines the efficacy against an emerging viral pathogen based on the classification into which the emerging pathogen is grouped. (EPA uses the Spaulding Classification model, which tiers microorganisms based on levels of resistance to being killed by disinfectants.)
Antimicrobial label amendment review takes time: EPA estimates four to 12 months of review for a new product or label amendment. Another option may be a “fast track” amendment, which would significantly cut down on review time and cost, but certain criteria must be met, including that no new scientific data need be submitted. Given the time needed for administrative review, it may be impractical for registrants that do not already have the relevant efficacy approvals to quickly be approved to make claims against SARS-CoV-2.
Registrants should review their currently approved master labels and consider whether a label amendment for efficacy against one or more of the Emerging Viral Pathogen classifications is feasible. There will undoubtedly be future emerging pathogens that also trigger this EPA guidance.
5.EPA maintains other pathogen-specific lists. This is not the first time EPA has compiled a public-facing list of products specifically approved to make claims against a specific pathogen. SARS-CoV-2 is EPA’s “List N.” Lists A through M can all be accessed here. Other “common pathogens” covered in these lists include HIV-1, Hepatitis B and C, norovirus, MRSA, Ebola and avian fluBut the SARS-CoV-2 list is the only one governed by the Emerging Viral Pathogen guidance.