According to EPA, Pesticide law defines a “pesticide” (with certain minor exceptions) as:

• Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest
• Any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant
• Any nitrogen stabilizer

The length of time involved in obtaining a federal registration depends on many factors such as the proposed uses of the product, the formulation of the product and how the data requirements will be addressed. Delays can be avoided by submitting quality packages in the initial submission and working hand-in-hand with EPA during the review process. TSG can provide time estimates for the preparation of the pesticide application package as well as an estimate of EPA’s time to review the application package once it is submitted to EPA.

The data requirements that are needed for an EPA pesticide registration are dependent on the proposed product uses including location and claims made on the labeling. The formulation of the proposed product can also impact the type of data required. There are many ways the data requirements can be addressed such as data citation, waiver rationales and lab generation. The data requirements for pesticides can be found in 40 CFR Part 158. TSG can provide a list of data requirements specific to your proposed product through a registration strategy assessment document or a data gap analysis.

The costs and fees that go into getting a pesticide registered with EPA vary greatly depending on numerous factors. These factors include how the product will be used (for example, public health vs non-public health), the formulation of the product (for example, new active ingredient vs existing active ingredient in EPA’s database), and how the data requirements will be addressed (for example, data citation vs lab generation). TSG can provide cost estimates specific to the proposed product upon request.

Pesticide registrations with the EPA must be maintained throughout their life cycle through various obligations. EPA requires annual maintenance fees to be paid per product. Furthermore, if EPA issues a data call-in that is applicable to your product, the data call-in must be addressed by the product registrant. Occasionally, EPA issues other labeling and data mandates outside of the data call-in which must also be addressed. Lastly, if a registrant owns an EPA-registered establishment facility, annual reports are required to maintain the establishment registration. TSG can assist companies with the above-mentioned tasks as well as other EPA obligations.