The EPA sets data requirements based on three active ingredient categories: Conventional chemicals, Biochemicals, and Microbial. These categories do not exactly match the three classifications of pesticides defined by the EPA, which are Conventional, Biopesticide, and Antimicrobial. Figure 1 below demonstrates how these categories and classifications overlap. Biopesticides may be composed of biochemical or microbial active ingredients.

Figure 1. Definitions and relationships between classifications of completed pesticide products and categories of pesticide active ingredients.

Data required for pesticide registration submission must be collected using standardized methods set forth by the EPA or the Organization for Economic Co-operation and Development (OECD). Each required data category has an accompanying series of necessary tests. The various series identify and detail the data required for registration, as well as the test methodology. Additional EPA-accepted standardized test methods are available on the OECD webpage. See the table below for data series and corresponding OECD test methods.

See the table below for EPA data series numbers. Note that tests are reviewed by one of two divisions in the EPA Office of Pesticide Programs: the Registration Division (RD) or the Biopesticides and Pollution Prevention Division (BPPD). Questions regarding tests should be directed to the appropriate division.

Additional details on data requirements for Biopesticides can be found in CFR 40 Part 158 Subpart U

The studies required under Part 158 provide the scientific basis for characterizing the potential risks associated with pesticide exposure. There is considerable flexibility available to the EPA in implementing Part 158. For example:

• Additional data may be required (Section 158.75),
• Alternative approaches may be accepted (see OECD Tests in the table above), and
• Studies can be waived (Section 158.45).

Collection of the required pesticide registration data may require field trials. Unregistered pesticides may be applicable for an Experimental Use Permit (EUP). Although the complete set of registration data may not be available at the time of an EUP request, most studies and resulting data must have been collected before the EPA will grant an EUP. An EUP must also be approved by the state in which the experimental use is to take place. To determine the policy of an individual state, use the external link to the National Pesticide Information Center or the internal link to the US Regulatory Map.

• List of EPA-registered Biopesticide Active Ingredients
• Navigate to the EPA webpage for a list of required data Test Guidelines
• Reviewer requirements. View a list of Standard Data Evaluation Formats used for evaluation by data reviewers.
• BPPD Internal Application Checklists
• Tips for Avoiding Confidential Statement of Formula or Product Chemistry Issues with Biopesticides
• See necessary registration forms, Pesticide Registration Manual: Ch. 20 – Forms and How to Obtain Them
• If your proposed product is substantially similar to another EPA-registered product, you may be able to cite data from existing studies.
• If citing another organization’s data, you must first determine whether you need to pay or get authorization from the data owner to use it. More can be found in the Pesticide Registration Manual: Ch. 10 – Data Compensation Requirements
• Determine the registration fee(s) and review timeframe for your product
  • The Pesticide Registration Improvement Act (PRIA, aka PRIA 5) requires the submission of fees associated with EPA assessments of pesticide data.
  • Use the PRIA Fee Determination Decision Tree to find the fees and review timeline associated with your product.
  • If you are a small business, academic institution, non-profit, or state/federal office, you may qualify for a fee waiver.
• Review Pesticide Registration Manual: Ch. 3 – Additional Considerations for Biopesticide Products
• Schedule a pre-registration meeting with the Office of Pesticide Products Biopesticide and Pollution Prevention Division. See contact information below.

This information was collected from the 40 CFR 158 or EPA’s Test Guidelines for Pesticides and Toxic Substances unless otherwise noted. Please visit the website for more information.