EPA on March 31 provided a formal relaxation of certain FIFRA requirements for pesticides listed on EPA’s “List N” of products expected to be effective against the coronavirus. This temporary policy relaxes requirements to receive EPA approval of changes in sources of certain common active ingredients—such as ethanol, hydrogen peroxide, and citric acid—in response to “reports of supply chain disruptions by pesticide registrants who manufacture disinfectant products on EPA’s List N.”
Previously, EPA’s PR Notice 98-10 required EPA to receive prior notice of any change in the source of an active ingredient, even if the new source was substantially similar to the previous source. The notification process allowed EPA 30 days to disapprove the modification, and the notifying registrant could not offer the modified product for sale until 60 days elapsed or it received express approval from EPA.
In its new guidance document, EPA has relaxed these requirements for eight specific active ingredients, when used for products included on List N. These active ingredients are commonly-used commodity substances, such as ethanol and hydrogen peroxide. So long as the “substantially similar” requirements of PR Notice 98-10 are satisfied, registrants may sell List N products using alternative sources of active ingredients immediately after providing notice to EPA, even if those ingredients are from an unregistered source, so long as this guidance remains in effect. EPA has indicated it may make further changes to this new policy on an as-needed basis, but will provide at least seven days’ notice before terminating the policy.
Registrants will still need to ensure, among other requirements, that (1) the new source has the same certified limits as the original, and (2) that if the new source has an inert ingredient or an impurity of toxicological significance, the new source has the same upper certified limit for that substance.
This guidance marks the second formal relaxation of certain FIFRA requirements in response to the COVID-19 pandemic, after last week’s similar relaxation of requirements relating to inert ingredients (which was not limited to List N products). These developments signal that EPA is willing to consider providing flexibilities to registrants due to the “critical need for available disinfectants during the current COVID-19 pandemic,” so long as those flexibilities “will not cause any unreasonable adverse effects to human health and the environment.”
Finally, EPA has indicated it may consider adopting this approach more broadly going forward. EPA’s notice indicates that the agency “may consider a permanent modification to PR-Notice 98-10 with respect to the use of commodity chemicals as sources of active ingredients in pesticide products,” after providing notice and an opportunity for public comment.