Exemption Eligibility Review & Guidance
25(b) Minimum Risk Pesticide
25(b) Exemption Assessment
A Minimum Risk Pesticide, commonly referred to as a “25(b) pesticide,” is a pesticide or biocide product that may qualify for exemption from federal registration with the U.S. Environmental Protection Agency (EPA) under Section 25(b) of FIFRA.
How Regulatory Roadmap Solutions Can Support You
Regulatory Roadmap Solutions provides focused guidance to help determine whether your product aligns with 25(b) exemption criteria.
- Eligibility assessment based on formulation and intended use
- High-level labeling and claim considerations
- Clear direction on next steps
Assumptions
This service is limited to an initial eligibility and regulatory positioning assessment based on information provided. It does not include preparation, submission, or direct engagement with the U.S. Environmental Protection Agency.
If a product does not meet all applicable exemption criteria, the product may not qualify for the FIFRA Section 25(b) exemption, and the sale or distribution of the product without EPA registration could potentially constitute a violation of FIFRA unless another exemption applies.
In certain situations where exemption eligibility, product classification, labeling, or regulatory interpretation may fall within a regulatory gray area, an EPA M009 review may be beneficial. The EPA’s Pesticide Registration Improvement Act (PRIA) M009 fee category provides a formal pathway for obtaining Agency feedback or determination regarding whether a specific product may qualify for the FIFRA Section 25(b) minimum risk pesticide exemption.
If an M009 submission or other EPA engagement is determined to be beneficial or necessary, this can be supported under a separate scope and fee to be determined.
Understanding whether your product qualifies is a critical first step.
A focused review can provide clarity before time and resources are committed in the wrong direction.
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