By Lisa M. Campbell and Lisa R. Burchi

In response to the increasing concerns regarding emerging viral pathogens that are not on U.S. Environmental Protection Agency (EPA)-registered disinfectant labels, EPA announced on April 7, 2016, that it was updating its Guidance regarding emerging viral pathogens.  Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is authorized to evaluate the efficacy of antimicrobial products intended to control pathogens that can be detrimental to public health.  Many believe that the process under which registrants can identify “effective disinfectant products for use against emerging pathogens,” and the process for EPA to “permit registrants to make limited claims of their product’s efficacy against such pathogens,” have not been clear and efficient.  EPA notes, for example, that “[emerging] pathogens are often unavailable commercially, and standard methods for laboratory testing may not have been developed,” such that it “can be difficult to assess the efficacy of EPA-registered disinfectants against such pathogens in a timely manner and to add these viruses to existing product registrations.”

EPA hopes that its Guidance will “expedite the process for registrants to provide useful information to the public” regarding products that may be effective against emerging viral pathogens associated with certain human or animal disease outbreaks.

EPA’s new draft Guidance document, Draft Guidance to Registrants:  Process for Making Claims Against Emerging Viral Pathogens Not on EPA-Registered Disinfectant Labels, describes “a voluntary two-stage process to enable the use of certain EPA-registered disinfectant products against these emerging viral pathogens, uses not previously identified on the product label”:

• First Stage:  This stage may be performed prior to any outbreak. EPA summarizes the first stage as follows:  “registrants with an eligible disinfectant product may submit a request, via label amendment, to add a designated statement to the master label and additional terms to the product registration.  If the product meets the eligibility criteria suggested in this Guidance, [EPA] generally will approve the amendment.  Approval of the amendment would include additional terms and conditions of registration regarding how the designated statement may be published and communicated.”
• Second Stage:  This stage would occur only during a human or animal disease outbreak caused by an emerging virus.  EPA summarizes this stage as follows:  “In this stage, registrants of products with the previously mentioned label amendment and terms of registration would be allowed to use the designated statement in off-label communications intended to inform the user community/public that the disinfectant product(s) may be used against the specific emerging viral pathogen.  These off-label statements can inform the public about the utility of these products against the emerging pathogen in the most expeditious manner and can be more easily removed once the outbreak has ended than statements on a label.”

Comments related to clarity of this Guidance will be accepted until May 6, 2016.  For more information, please see our memorandum EPA Announces Updated Guidance for Antimicrobial Pesticide Products Intended to Combat Emerging Pathogens.