EPA Announces Efforts to Close Out Specific Antimicrobial Notification Actions to Reduce Backlog and Improve Efficiencies

On June 29, 2023, the U.S. Environmental Protection Agency (EPA) announced a new effort closing out notification actions for minor pesticide label or product formulation changes in an effort to reduce the backlog, which, EPA states, will allow it to focus its limited resources on addressing higher priority actions. EPA announced it has closed out approximately 2,000 antimicrobial actions submitted to EPA prior to October 1, 2022. EPA states that the notification actions do not impact the product’s ability to be used safely according to the approved label instructions and have no impact on human health or the environment. The close out only applies to notification actions, which do not fall under the Pesticide Registration Improvement Act (PRIA). The close out is effective as of June 28, 2023.

According to EPA, its backlog of pesticide actions has continued to grow over the years due to a declining budget, less staff, a growing workload, and increased complexity of the actions submitted to EPA. The total number of pesticide actions coming into EPA per year has ranged from 10,000 to 20,000 since 2004, with a peak in 2021 during the COVID-19 public health emergency.

As a result, EPA’s Antimicrobials Division (AD) has reported a backlog of more than 6,693 overdue non-PRIA pesticide actions of which approximately 2,000 have now been closed out. EPA states that closing out notifications submitted before October 1, 2022, will save it time and resources to address the remaining notification backlog.

Under Pesticide Registration (PR) Notice 98-10, registrants may sell and distribute antimicrobial products bearing labels that are consistent with the requested notification changes 60 days after submitting a notification to EPA and after receiving either an approval or no response from EPA. Some types of changes that may constitute notifications under PR Notice 98-10 include:

• Brand name changes;
• Addition of certain indoor, nonfood use sites;
• Modification to packaging and related labeling statements;
• Addition of storage and disposal statements (as specified in the Container Rule and PR Notices 83-3 and 84-1);
• Changes to certain label claims and limited updates to a product’s confidential statement of formula (CSF);
• Use of symbols and graphics; and
• Certain other minor label revisions.

According to EPA, all of the registrant-submitted changes being closed out have exceeded the 60-day window for EPA’s review and registrants are, therefore, allowed to sell and distribute their products without EPA approval.

EPA states it will not send letters to registrants regarding the closed notifications, nor enter the affected labels on the EPA’s Pesticide Product and Label System (PPLS) database. EPA will, however, notify the registrant if EPA determines in the future that any of these changes were actually not eligible to be made via notification under PR Notice 98-10.

Companies can contact the AD at AD_BL_Actions@epa.gov if they have any questions on their label or CSF notifications to get a complete list of notification actions for their specific product(s), including those closed out as described in this announcement. EPA states it will coordinate with state co-regulator partners to ensure they are aware of these closed notifications. No further communication with EPA is required by companies whose notifications are affected by the close out.

Commentary

The closed-out actions have exceeded the 60-day window for EPA’s review, therefore, registrants are allowed to sell and distribute their products without approval of the changes submitted by notification. As the closed-out actions have not been reviewed by EPA, the actions have not been approved, only closed out; thus, EPA may determine in the future that the submitted changes were not eligible to be made via notification under PR Notice 98-10. In that case, the registrant likely would need to resubmit the action as an amendment.