M009 PRIA Fee Category

A voluntary request that EPA determine (1) whether and how a product is regulated under FIFRA (e.g., a Section 3 pesticide, an exempt treated article, a pesticidal device, or excluded plant nutrient, plant inoculant, soil amendment); (2) whether a specific substance is eligible for inclusion as an active ingredient and/or inert ingredient permitted in exempted minimum risk pesticide products under 40 CFR § 152.25(f)(1); or (3) whether a plant-incorporated protectant is eligible for FIFRA exemption under 40 CFR Part 174 subpart E. Each M009 application can request a determination for only one product or substance (i.e., different products or multiple substances would require multiple M009 applications).

Each M009 determination is based on the particular facts about the product available at the time EPA considers the M009 application. If an applicant subsequently makes changes to the product (or its claims), a previous M009 determination may no longer be applicable to the changed product. Applicants may submit a new M009 application if they want EPA to reassess the product and the impacts of any changes. 

Applicants must submit sufficient information to allow EPA to make a jurisdictional determination on the product. Failure to provide this information may result in the EPA not being able to make the determination or delays in review.

This may include the following materials, to the extent necessary to make EPA’s jurisdictional determination.

• A cover letter requesting a specific type of FIFRA determination (e.g., device, exempt treated article, barrier).
• A clear description of the product, including manufacturing methods and formulation, if appropriate. Generally, formulation information may include:
  • Whether the product contains an EPA registered pesticide;
  • Identity and CAS numbers, if available, for each ingredient and any known impurities;
  • Genus, species, and any strain/isolate identifier for any microorganism(s) and information on whether the microorganism(s) are naturally occurring or intergeneric; and
  • Purpose of each ingredient including the scientific and theoretical basis when applicable.
• A clear description of (1) how the product is used, including, where relevant, application methods, application rate(s), and directions for use; (2) any claims made for the product (g., proposed label or labeling claims, web-based content, print or other advertising); (3) precautionary statements, warnings, or caution statements, if any; and (4) the complete brand name(s) of the product. Generally, this should include:
• A complete copy of the product label and/or manual(s); and
• Any materials distributed about the product (including pamphlets, brochures, advertising materials and/or website materials).
• A clear description of how the product works (e.g., how the product does or does not kill, destroy, repel, trap, or mitigate a pest). Where appropriate, this description should include:
  • Specifications used in the operation of the product
  • Any input or output substances (identified by common name and CAS number) associated with the product
  • Any schematic diagram, engineering drawings, diagrams, flow diagrams, or patent application information. Generally, patent application information (for both United States or international patents), should include the application number(s), the corresponding patent office, and any pre-grant publication or issued patent. (Primarily for Device Determinations)
  • Digital copies of photographs of the product from all sides. (Primarily for Device Determinations)

Information claimed as confidential must be clearly marked. EPA will consider any information not so marked as not subject to a claim of confidentiality and may make the information publicly available without further notice, except as limited by FIFRA section 10(g).

Additional information that may be helpful to include for a FIFRA determination for products containing microbes can be found at the following link: Pesticide Determination Requests for Microbial Products.

The M009 category also covers exemption eligibility determinations under EPA’s “Exemptions of Certain Plant-Incorporated Protectants Derived from Newer Technologies” rule. Additional information that may be helpful to include for applicants submitting a request for this type of determination is available in the preamble and regulatory text for that rule (88 FR 34756; 40 CFR § 174 subpart E).