EPA on April 14 expanded its formal relaxation of certain FIFRA requirements for pesticides listed on EPA’s “List N” of products expected to be effective against the coronavirus.  This expansion builds on EPA’s March 30 iteration of this temporary policy, which this blog previously discussed.

Notably, EPA has found “good cause” to take these actions without notice and comment in light of the pandemic, an issue that was not discussed in its March 30 guidance.  EPA also characterizes these revisions as procedural in nature, and so subject to an exception to notice-and-comment rulemaking under the APA—a rationale that would apply regardless of the pandemic.  5 U.S.C. § 553(b).  This represents one of EPA’s first invocations of these exceptions during this pandemic, and may be a harbinger of future efforts to rapidly modify its rules if the agency believes it necessary.  Notably, EPA has invoked these exceptions even though its own regulations require notice and comment, and do not contain these exceptions.  See 40 C.F.R. § 152.46.

EPA’s expansion of this temporary policy provides the following additional flexibilities for List N pesticides, relating to sourcing ingredients and registering pesticide-producing establishments:

  • Commodity Active Ingredients With Different Purities May Be Substituted By Notification. EPA will allow for commodity active ingredients that are not “similar” to the registered active ingredient because their purity differs to be substituted by notification, so long as (1) the nominal concentration of the active ingredient does not change, and (2) any adjustment in inert ingredients to compensate for the change in purity of the active ingredient is limited to water.  Previously, such changes would require EPA approval of an amended pesticide registration.
  • Active Ingredients With Different Purities May Be Substituted for Registered Sources of Active Ingredients By Notification. EPA will allow an active ingredient, including non-commodity active ingredients, to be substituted for a non-similar active ingredient (i.e., the same active ingredient with a different purity), so long as (1) the alternate source is registered, (2) the nominal concentration of the active ingredient does not change, and (3) the only change necessary to the inert ingredients is limited to water.  Previously, such changes would require EPA approval of an amended pesticide registration.
  • “Similar” Non-Commodity Active & Inert Ingredients May Be Used By Notification. “Similar” non-commodity active ingredients may be substituted by notification and released for sale immediately after the notification is submitted to EPA.   EPA has also adopted this approach for “similar” inert ingredients.  Previously, such notifications had to be submitted at least 60 days prior to sale of the product.
  • Establishments May Produce List N Pesticides By Notification. If the active ingredient source is registered, already-registered establishments may also produce List N pesticides so long as EPA is notified, and product may be released for sale immediately after the notification is submitted.  Previously, companies had to await EPA approval.

EPA has also hinted that it is open to providing further flexibilities if needed, noting the importance of ensuring “that Americans continue to have access to effective and approved disinfectants that can help combat the spread of COVID-19.”