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By Lisa R. Burchi and Margaret R. Graham

On September 2, 2016, the U.S. Environmental Protection Agency (EPA) issued guidance to registrants on the process for making claims against emerging viral pathogens not on EPA-registered disinfectant labels (Guidance).  A draft of this guidance was issued in April 2016 and comments were sought at that time.  More information concerning the draft guidance is available in our blog item EPA Combats Emerging Pathogens Through Updating Guidance for Antimicrobial Pesticide Products.

The current Guidance document, which EPA states “provides general guidance to registrants that can be used to identify effective disinfectant products for use against emerging viral pathogens and to permit registrants to make limited claims of their product’s efficacy against such pathogens,” includes changes incorporated following EPA’s review of the three public comments received in response to that draft.  

The Guidance retains the voluntary two-stage process, but amends the first stage as indicated:

  • In the first stage, which may be performed prior to any outbreak, registrants with an eligible disinfectant product may submit a request, via label amendment or during the registration of a new product, to control a specific emerging viral pathogen 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.

In its response to comments document, EPA responded to several comments, including:

  • Changes were made to EPA’s mandated non-label statements to remove certain language that could be considered redundant.
  • EPA is developing a coordinated process with the Centers for Disease Control and Prevention for the purpose of providing a more standardized and consistent approach to emerging viral pathogen outbreaks.  Once this process is established, the agency expects to consult with the U.S. Department of Agriculture to develop a similar approach.
  • The Guidance document allows for the addition of emerging pathogen claim language to the master label during the new product registration process if the product is eligible.  Additional language has been added to multiple locations in the Guidance document to clarify that the process is appropriate for new product registrations.
  • EPA “may consider allowing use of additional modes of claim communication under future versions of this Guidance document, however, hangtags and other promotional materials are not authorized at this time.  Because the statements authorized under this Guidance are pesticidal claims that do not meet the FIFRA registration criteria, it is essential that these off-label claims are not made outside of an emerging pathogen outbreak as described in the Guidance. Accordingly, the Guidance limits these off-label claims primarily to communications outlets that are wholly within the registrant’s control (800 numbers, social media and websites) from which the off-label claims can be immediately removed. Hangtags and other promotional materials directed towards general consumers are largely out of the registrant’s control once the products enter the chain of commerce, and may persist long after the period during which the off-label claims are authorized.”

EPA also notes that this Guidance document “provides general guidance to EPA, pesticide registrants, applicants for pesticide registrations, and the public.  This guidance is not binding on EPA or any outside parties, and EPA may depart from the guidance where circumstances warrant and without prior notice.”


 

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.


 

By Lisa M. Campbell

On July 01, 2015, the U.S. Environmental Protection Agency (EPA) issued a notice announcing the availability of and requesting public comment on a proposed guidance document called the Antimicrobial Pesticide Use Site Index (USI)

In 2014, EPA issued a final rule amending the regulations setting forth the data requirements that support an application to register a pesticide product.  The final rule contains the data requirements specifically applicable to antimicrobial pesticides, which were codified in 40 C.F.R. Part 158, subpart W.  The final rule lists 12 antimicrobial use patterns in 40 C.F.R. § 158.2201.  The data requirements applicable to a pesticide product depend in part on the product’s use pattern.  The general use patterns are broad designations and are used as columns in the antimicrobial data requirements tables to identify which data requirements might be pertinent to the particular pesticide use site.

EPA has developed the USI to assist antimicrobial pesticide applicants and registrants and EPA staff to identify the use pattern that applies to a pesticide product, and thus the data requirements that must be met to register the product.  EPA states that the USI serves as a compilation of the specific use sites that are commonly listed on antimicrobial labels and links these commonly listed use sites with the twelve general use patterns.  

The posting of this proposed guidance document for public comment is intended to satisfy a condition of the March 2, 2015, settlement agreement between EPA and the American Chemistry Council (ACC) that followed ACC’s July 2013 initiation of a legal challenge to the data requirements regulation in the U.S. Court of Appeals for the District of Columbia Circuit.  Comments are due by July 31, 2015.