The US Environmental Protection Agency issued a revised temporary amendment to ensure that pesticide disinfectant products remain available during the coronavirus (COVID-19) pandemic by taking measures to address supply chain disruptions.
Under the temporary amendment, the US Environmental Protection Agency (EPA) will permit registrants to immediately sell—without prior EPA approval—currently registered pesticide disinfectant products with active ingredients drawn from certain alternative sources. EPA will also permit registrants to manufacture—without prior EPA approval—specified pesticide disinfectant products in additional EPA-registered establishments. EPA hopes these temporary measures will address supply chain disruptions that have hampered the production of surface disinfectants needed to combat the spread of COVID-19.
EPA’s March 30 Modification
EPA first streamlined the production of currently registered pesticide disinfectant products on March 30, when it issued a time-limited modification to Pesticide Registration Notice (PR Notice) 98-10. The March 30 modification permitted registrants of certain disinfectants—those listed on EPA’s List N: Disinfectants for Use Against SARS-CoV-2 (List N) that contain specified active ingredients—to use a similar source[1] of an active ingredient without receiving prior EPA approval.
Before the modification, registrants generally had to obtain EPA approval of an amendment to their pesticide registrations identifying the new source of the active ingredient. The application and approval processes were often time consuming.
EPA’s April 14 Revised Modification
Building on the initial success of the March 30 modification, EPA took additional action to increase the availability of pesticide disinfectant products. On April 14, EPA issued a revised time-limited modification to PR Notice 98-10, which permits all of the registration modifications outlined in the March 30 modification and expands the types of permissible changes to pesticide registrations. While the April 14 modification remains in effect, registrants may immediately sell certain pesticide disinfectant products upon notifying EPA of specified formulation and manufacturing facility changes.
First, the April 14 modification allows List N disinfectants with registered sources of active ingredients to be manufactured in EPA-registered establishments without prior EPA approval. If registrants seek to add EPA-registered establishments for formulations of such products, they may sell those products immediately upon EPA’s receipt of appropriate notification.
Second, the April 14 modification provides registrants additional flexibility in making formulation changes. For example, registrants may now use an alternative source of an active ingredient with a different purity (i.e., not a “similar” source) if they adjust the amount of inert ingredients to keep the concentration of the active ingredient in the resulting product unchanged.
Further, “if the nominal concentration of active ingredient in the product remains the same and adjustment in inert ingredients is limited to water only, this change will be allowed by notification and confirmatory efficacy data are not required.”
EPA will regularly assess the need for the April 14 modification and make any necessary changes. The agency emphasized that these modifications are temporary, and will not result in any substantive changes to existing approved product formulations. Any permanent modifications to PR-Notice 98-10, EPA explained, will be preceded by an opportunity for public comment.
EPA has committed to continue developing flexible responses to combat the spread of COVID-19.
Coronavirus COVID-19 Task Force
For our clients, we have formed a multidisciplinary Coronavirus COVID-19 Task Force to help guide you through the broad scope of legal issues brought on by this public health challenge. We also have launched a resource page to help keep you on top of developments as they unfold.
[1] For a source to be “similar,” the “active or inert ingredient obtained from the source [must] have the same [Chemical Abstracts Service] number as well as the same purity.”
