US EPA notification close out - Antimicrobial Division
On June 29, 2023, the Antimicrobial Division (AD) of the Office of Pesticide Programs (OPP) in the Environmental Protection Agency (EPA) published a statement that all pending notifications of minor label and formulation changes submitted prior to October 1, 2022 will be “closed”. By closing versus the standard acceptance of notifications, AD will not be issuing new stamped, accepted labels nor will they be providing a list of notified Confidential Statements of Formula (CSF).
In lieu of providing specific letters accepting each notification that is pending, AD will permit registrants to obtain a list of closed notifications by reaching out to them directly to obtain a complete list of notification actions for their specific product(s). AD will also be providing a list of all closed notifications to each state pesticide registration division. As shared by AD in recent discussions with industry, closing these actions will eliminate approximately 2,000 notifications that are in the AD backlog, and will leave approximately 200 notifications in backlog status.
What are notifications?
You may be asking yourself, what are notifications? A notification is a minor modification to a registration that EPA has determined to have no potential unreasonable adverse effect to the environment (1). Examples of notifications that are within the scope of this close out are:
- Label-related notifications
- Changes to the primary or alternate brand names for a registration
- Addition of certain indoor, nonfood sites to the registration
- Adding, revising, or deleting advisory statements
- Changes in packaging and related claims
- Product composition claims
- Other minor types of labeling changes that the Agency has declared within PR Notice 98-10
- Product chemistry notifications
- Alternate source of active ingredient that is registered for the same use as formulated product
- Change in source of an inert ingredient
- Certain changes of nominal concentration or certified limits of inert ingredients
- Alternate source for starting materials for integrated system products
- Change in a formulation process for a product made by a non-integrated system
- Fragrance submissions in compliance with the Pilot Fragrance Notification Program
AD has previously communicated this plan with state registration authorities, and the states have expressed support of this plan. For a product submission to any state, it is important to inform the state reviewer when a deviation from the registration label posed on the Pesticide Product Labeling System (PPLS) is due to a closed out notification.
In addition to AD, there are two other registering divisions within OPP, Registration Division (RD) and Biopesticides and Pollution Prevention Division (BPPD). At this time, neither RD nor BPPD will be closing out backlog notifications like AD. If this closing of notifications is considered a success by these divisions, they will make an independent decision to execute a similar close out procedure.
Supporting market needs
TSG is taking the lead in identifying its clients’ pending notifications that have been closed out. We will communicate the resulting registration status with each client, as we obtain the information from the Agency. If you have any questions, please do not hesitate to reach out to TSG at [email protected]