What information do you need to do a preliminary evaluation of a proposed pesticide registration project?
- What is the nature of your product? Active ingredient(s) only? Active ingredient(s) plus other ingredients? Both?
- What is/are the proposed use(s) of your product?
- What pesticidal claim(s) is/are planned?
- How is your product used? What are your proposed directions for use?
- Where would your product be used?
- Who will be the end users? Professionals? Home owners? Both?
- Is your company the manufacturer of the product, the seller of the product, or both?
- Will your company be buying EPA registered active ingredient?
- If yes, is it registered for the uses that are planned for your product?
- If no, is your company willing to buy EPA registered active ingredient to save time and money, and is the registrant willing to be a supplier to your company?
- Is your product:
- Substantially similar to an existing EPA registered product?
- Somewhere in between?
- Has anyone confirmed that your ingredients other than the active ingredient have been approved for use by EPA for the proposed use(s)?
- Can you confirm that no tweaks in the product composition are planned or likely in the near term?
- Has your product been tested to confirm that it works according to the proposed label?
- All uses?
- Under Good Laboratory Practices?
- Other than performance testing, what additional studies (if any) have been conducted using your product?
What kinds of data are required for a typical EPA pesticide registration?
The most common types of EPA applications are for formulated products produced using an EPA registered active ingredient that is registered for your proposed use(s). For these most common EPA pesticide registration applications, EPA will require administrative items plus:
- Product chemistry data (description of how your product is made and physical-chemical characteristics, e.g., pH);
- Acute toxicology data; and
- Product performance (a.k.a. efficacy) data.
Food uses require residue chemistry data. Products for use on cats and dogs (e.g., to control fleas and ticks) require companion animal safety data. Some products require child resistant packaging data.
Active ingredient applications and applications involving an unregistered source of active ingredient require more data types.
Does EPA charge an application fee?
Yes, most EPA applications requirement payment of a fee. The fees are referred to as PRIA (Pesticide Registration Improvement Act) fees. They are adjusted periodically and are intended to reflect the magnitude of work required by EPA to complete the science review and risk assessment. For the period of October 1, 2019 to September 30, 2021, the PRIA fee schedule is published in the October 1, 2019 Federal Register (pages 52085 to 52104). PRIA fees range from $1,342 to $790,737. This is a 1- time fee. After registration, EPA charges an annual maintenance fee for each product.
How long does EPA review take?
The October 1, 2019 Federal Register Notice also includes EPA review timelines that EPA endeavors to meet. For applications requiring the review of data, the target EPA decision times range from 4 months to 24 months (always plus 21 days for submission front-end processing).
How much does an EPA registration cost and how long does it take?
Time and cost estimates for EPA registration projects are themselves research projects. The specifics of every project are different. The list of EPA data requirements need to be determined. How the data requirements will be fulfilled needs to be determined. If new studies will be conducted, study costs and timelines need to be estimated and need to reflect laboratory availability. The results of some studies are needed before other studies can be started. If data previously submitted to EPA are planned to be cited, the cost of data compensation paid to the original data submitter needs to be evaluated. Regulatory project management costs need to be considered. Food uses have more requirements than non-food uses. The time and cost of food uses are greater than those for non-food uses. In general, the first application has the greatest cost and requires more time than an amendment to an existing registration.
Am I ready to sell when my product has an EPA registration?
No. Your product will also need state registration in each state in which it is offered for sale. For most states, this is an administrative matter (application form, fee, product label(s), and sometimes Safety Data Sheets and Confidential Statement of formula). Some states also require data summaries. California requires submission and review of registration study reports, including efficacy reports.