U.S. EPA proposes major updates to post-registration amendments

The United States Environmental Protection Agency (EPA) recently announced the availability of draft Pesticide Registration Notice (PRN) 2025NEW, which proposes updated guidance on notifications, non-notifications, and minor formulation amendments for pesticide products. The notice would replace PRN 98-10 in its entirety and aligns EPA’s processes with statutory and regulatory changes – including those under PRIA.

Public comment period ends March 23

If your company has yet to comment on the draft notice, you have until March 23, 2026 to do so. EPA is encouraging stakeholders to review the proposed changes and share feedback that will shape the final policy. If your company manufactures any type of product regulated by EPA, including conventional pesticides, biopesticides and antimicrobial pesticides, it’s important to understand how the updated pathways could affect your registrations.

To support your review, Sagentia Regulatory has summarized the key areas of impact below.

Notifications permitted under PR Notice 2025-NEW

PRN 2025-NEW allows registrants to streamline low-risk label updates via notification. It enables updates to brand names, adding or deleting certain non-public-health pests, and adding indoor nonfood sites for antimicrobial products when no new data is required. Specific packaging-related labelling changes, the addition of approved symbols, graphic, tables, and certain marketing claims that do not require data review are also permitted. Registrants may update label statements tied to product composition – such as fragrance descriptors, qualified “improved” claims, inert-ingredient transparency, and water-based statements – when criteria are met.

The notice further allows defined risk-reduction statements and limited revisions to directions for use that do not alter exposure or application rates. Overall, PRN 2025-NEW expands and clarifies the categories of label changes eligible for notification, compared to PRN 98-10.

Minor Formulation Amendments under PR Notice 2025-NEW

PRN 2025-NEW allows certain Minor Formulation Amendments (MFAs) to be processed through an accelerated review pathway. This includes the addition, deletion, or substitution of inert ingredients when the active ingredient concentration and certified limits are unchanged, and no new data are triggered.

It also permits fast-track changes to colorants and fragrances – including those submitted under the Fragrance Notification Program – when they meet composition, concentration, and tolerance-exemption criteria. EPA aims to review MFAs within 45 days for conventional and biopesticide products and 90 days for antimicrobial products.

Non-notifications under PR Notice 2025-NEW

PRN 2025-NEW allows certain low‑risk updates without notifying EPA, including fixing typos and formatting issues, adjusting some packaging sizes, and adding non‑FIFRA elements like DOT symbols, trademarks, barcodes, and metric units.

It also permits non‑notification changes to company information, voluntary label‑format redesigns, and various non‑pesticidal statements (e.g., cleanup or price claims) as well.

Additional allowances include:

• Bilingual labeling
• State‑registration status statements
• “New formula” claims after EPA approval
• Taxonomic pest‑name updates
• Warranty‑statement tweaks
• Certain updates to inert‑ingredient sources and commodity inert listings

How Sagentia Regulatory can support you

The draft PR Notice 2025-NEW represents one of the most substantive updates to post registration amendment pathways in more than two decades. If you have any questions about how it could affect your product portfolio or amendment strategy, our team is here to help.

For support with planned changes, our US regulatory experts can:

• Advise whether they qualify for a submission as a notification
• Offer guidance about meeting requirements for fast-track treatment
• Determine whether they’re seen as a low-risk update
• Help navigate requirements and submission strategies