Effective June 28, 2023, all antimicrobial notifications submitted to the Antimicrobials Division (AD) prior to October 1, 2022 have been closed out by the Environmental Protection Agency (EPA). The Agency announcement, released on June 29, 2023, followed months of discussion between AD and the antimicrobial industry about how to best address the growing backlog of >6,000 non-PRIA actions. This notification close-out removes 2,000 actions from the resource-constrained department workload, allowing them to focus on other actions that necessitate a review.
Does “Closed” mean acceptance?
“Closed” notifications will not receive an EPA acceptance letter or be posted to PPLS, but registrants who submitted these notifications are “allowed to sell and distribute their products without EPA approval”. This means registrants bear the burden of ensuring their changes align with permitted notification changes.
What is a Notification?
Notification actions are submitted for minor changes to a product registration, which have “no potential to cause unreasonable adverse effects to the environment”. These changes, typically found in PR Notice 98-10, can include things like adding a product brand name, marketing claims aligned with existing data, packaging statements, graphics or source of inert ingredients, etc. Since notifications by nature include minor and non-public health-related changes, registrants are already “allowed to sell and distribute their products without EPA approval”, if EPA does not release a decision within 60 days after the notification was submitted.
How will the States handle ‘Closed’ Notifications?
EPA has had numerous conversations about this close-out process with U.S. state regulators to review and mitigate potential issues. State agencies have assured EPA that they will be able to review and accept these label changes without a letter of approval or posting to PPLS. It may be necessary though to obtain a list of the closed-out actions from AD to provide a state as proof the filing was made.
Next Steps
Though EPA will not be providing individual notices of closed out actions to registrants, the SRC team will contact our clients regarding notifications we submitted on your behalf to let you know if you will be affected by the closeout. Where applicable we will obtain a list of the closed-out actions from the Agency as additional supporting documentation your notifications were in fact closed.
EPA reserves the right to review these notification changes in the future. If they were not permitted under notification procedures, such as PR Notice 98-10, they will contact the registrant and require changes or removal. If you are unsure if your notification will be affected by this closeout, you can contact the EPA Antimicrobials Division at AD_BL_Actions@epa.gov to request a list of your notification actions directly or contact your SRC consultant for assistance.
The SRC Team is excited to see EPA take creative measures to address the action backlog and improve efficiency and working collaboratively to do so.
Rebecca Mannion
Federal Assistant Manager – Regulatory
Posted 07/05/23