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

Released om June 29, 2023

Today, the U.S. Environmental Protection Agency (EPA) is announcing a new effort to close out notifications of minor pesticide label or product formulation changes in an effort to reduce the backlog, which will allow EPA to focus its limited resources on addressing higher priority actions. Specifically, EPA is closing out approximately 2,000 antimicrobial actions submitted to the Agency prior to October 1, 2022, which 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).

EPA’s 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 the Agency. The total number of pesticide actions coming into the Agency 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 has a backlog of more than 6,693 overdue non-PRIA pesticide actions of which approximately 2,000 are being closed out. Today’s action will save the Agency time and resources to address the remaining notification backlog while maintaining full protection of human health and the environment.

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 the Agency. 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.

All of the registrant-submitted changes being closed out have exceeded the 60-day window for the Agency’s review and registrants are, therefore, allowed to sell and distribute their products without EPA approval. EPA will not be sending letters to registrants regarding the closed notifications, nor entering the affected labels on the Pesticide Product and Label System.​ However, if the Agency determines in the future that any of these changes were actually not eligible to be made via notification under PR Notice 98-10, the Agency will notify the registrant so that appropriate updates can be made to the label or CSF.

The close out is effective as of June 28, 2023. Companies that are unsure if they have any outstanding label or CSF notifications can contact the Antimicrobials Division by emailing  [email protected] to get a complete list of notification actions for their specific product(s), including those closed out as described in this announcement. The Agency is coordinating 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.