• A cover letter is not required but is highly recommended and should state the general purpose of the submission and identify each item in the application package.
• EPA welcomes requests for a pre-registration meeting.
• PR Notice 11-3 discusses both the recommended and the required procedures for submitting FIFRA data.

Procedures for submitting a complete application for registration of a pesticide product are detailed in regulations at 40 CFR 152.40 to 152.55. The Environmental Protection Agency (EPA) has also published the Pesticide Registration Manual as a resource for companies and individuals who want to have their pesticide products registered for sale in the United States. Detailed information for pesticide registrants (i.e., the company or individual applying to register a pesticide) concerning their responsibilities before, during, and after the review process is included in the manual, which can be found on the agency’s website.

A separate application for registration must be made for each pesticide product that will be distributed or sold. A pesticide product registration is required for each manufacturing use product or end use formulation.

Note: EPA has classified some or all of the uses of certain pesticides as “Restricted Use.” The “Restricted Use” classification restricts a product, or its uses, to use by a certified pesticide applicator or under the direct supervision of a certified applicator. Criteria used for determining whether a product requires the restricted use classification can be found in 40 CFR 152.170.

Cover letter

A cover letter is not required but is highly recommended and should state the general purpose of the submission and identify each item in the application package. It should also contain the email address of the applicant in order to receive registration milestone tracking emails.

Application form

Complete and submit an original Application for Pesticide Registration/Amendment Form (EPA Form 8570-1) with each application for registration. When EPA receives the application (and the applicable fee required), the agency will screen the application during a 21-day period to determine if it contains all required forms, labeling, and data formatted as described in the agency’s guidance in Pesticide Registration (PR) Notice 11-3, as well as documentation of fee payment.

The fee payment documentation may include a request for a fee reduction or waiver or an exemption. Any deficiencies identified during the 21-day screening that are not corrected by the applicant may lead to the agency’s rejection of the application. EPA will keep 25 percent of the fee.

Pre-registration meeting

EPA welcomes requests for a pre-registration meeting. This type of meeting can provide useful guidance to the applicant regarding information needed for registration. Applicants are encouraged to contact the appropriate branch assigned to the active ingredient in their product before submitting an application for registration. Contact the ombudsman for the division if the appropriate branch is unknown.

Pesticide Registration (PR) Notice 11-3

PR Notice 11-3 discusses both the recommended and required procedures for submitting Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) data. All required procedures contained within the document, generally indicated by use of the word “must,” were previously made mandatory by statute or regulation. Where indicated by the use of non-mandatory language such as “may,” “should” and “can,” EPA provides recommendations or guidance.

The PR Notice applies to all data that are submitted to EPA to support any application, petition, or submission intended to persuade EPA to grant, modify, or leave unmodified a registration or other approval required as a condition of sale or distribution of a pesticide. Such submissions may include, but are not limited to, the following:

• Application for registration or amended registration of a pesticide product under FIFRA 3 or 24.
• Submission of data required in conjunction with reregistration of a currently registered product under FIFRA 4 (or its registration review under FIFRA 3).
• Application for an experimental use permit under FIFRA 5.
• Submission of data in response to a notice issued by EPA under FIFRA 3(c)(2)(B).
• Petition to establish or modify a tolerance or an exemption from the requirement of a tolerance for a pesticide chemical residue under Federal Food, Drug and Cosmetic Act (FFDCA) 408.
• Studies submitted under FIFRA 6(a)(2).

Electronic submissions

Applications for pesticide registration can now be submitted electronically to EPA. Forms, studies, and draft product labeling may all be submitted via the Pesticide Submission Portal (PSP) which is accessed through EPA’s Central Data Exchange (CDX) Network (user registration is required). Application materials, tools, and resources for submission are all available on EPA’s website. Registrants currently submitting CDs or DVDs using the e-Dossier downloadable tool or their own builder tools based on EPA’s XML guidance may use the PSP and forego the costs of sending physical copies to EPA.

Note that applicants do not need to submit multiple electronic copies of any pieces of their applications. In PR Notice 2011-3, EPA made clear that the requirement to submit multiple copies of data is applicable only to paper submissions and, similarly, EPA interprets the requirement to submit five copies of draft labeling in 40 CFR 152.50(e) to apply only to applications made on paper. Since electronic submissions are easily reproducible, EPA will accept electronic applications containing one copy of all the required elements.