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Registering Pesticides

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Pesticide registration is the process through which EPA examines the ingredients of a pesticide; the site or crop on which it is to be used; the amount, frequency and timing of its use; and storage and disposal practices. EPA evaluates the pesticide to ensure that it will not have unreasonable adverse effects on humans, the environment and non-target species. Pesticides must be registered or exempted by EPA's Office of Pesticide Programs before they may be sold or distributed in the U.S. Once registered, a pesticide may not legally be used unless the use is consistent with the approved directions for use on the pesticide's label or labeling.

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EPA has separate review processes for three categories of pesticides:

The three processes share the same application materials, but there are differing data requirements and review policies that registrants must take into account in their submittal.

The process of registering a pesticide begins with submission to EPA of an application package. EPA's review of this application includes assessment of the hazards to human health and the environment that may be posed by the pesticide. Depending on the class of pesticide and the priority assigned to it, the review process can take several years. Biopesticides and reduced-risk conventional pesticides often can complete the process much faster, in as little as a year in some cases. Refer to the Pesticide Registration Manual (Blue Book) for more information about the pesticide registration process.

EPA publishes its annual workplan for conventional chemical pesticides. This workplan reflects the priority-setting (Pesticide Registration Notices 97-2 (PDF) and 98-7) process for these pesticides, which focuses on reduced-risk pesticides and pesticides that can replace methyl bromide or the organophosphate pesticides.

Resources for Registrants

Registration service fees - Provides information on registration fees, guidance on fee waivers and reductions and the implementation of the Pesticide Registration Improvement Act (PRIA) of 2003

The Pesticide Registration Kit is available online. This kit contains links to necessary registration forms, as well as to pertinent Pesticide Registration (PR) Notices, Federal Register Notices, contact lists and other information. In addition, individual forms for pesticide registration are available. These include the Application for Registration, the Confidential Statement of Formula, Formulator's Exemption Statement, and others. They are in PDF format and may be filled out on your screen, printed, and submitted to OPP.

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Electronic Data Submission - EPA is implementing electronic data submission and review tools to improve the efficiency and effectiveness of its regulatory processes.

EPA issues Pesticide Registration (PR) Notices to inform pesticide registrants and other interested persons about important policies, procedures and regulatory decisions. Often, a draft notice is made available for comment, followed by the official notice.

Templates for Use in Developing Pesticide Study Documents - EPA and the Canadian Pest Management Regulatory Agency have collaborated in developing templates for the agencies to use in reviewing pesticide studies. Based on these templates, the agencies have developed study profile templates that applicants can use in writing the reports on the studies they submit. By using these templates, applicants will be guided in providing the information necessary for agency review.

Experimental Use Permits - EPA grants permits to allow a pesticide producer to test a new pesticide, product, or use outside the laboratory. Experimental use permits (EUPs) are used for large-scale (more than 10 acres of land or 1 acre of water) testing of efficacy and gathering of environmental fate, ecological effects, and crop residue chemistry data. Regulations governing EUPs are found in 40 CFR 172. The EUP sets requirements for transportation, application, and disposal of unregistered test products. The Pesticide Registration Manual, Chapter 12 ? Applying for an Experimental Use Permit provides more information and the application form.

The Label Review Manual was developed as a training tool and guidance for reviews of pesticide product labels. The goals are to improve the quality of labels and increase the consistency of reviews. The manual describes what a pesticide is and what constitutes a label and labeling and also provides step-by-step instructions for reviewing a pesticide label and how unique issues have been handled in the past.

Data Sources provide guidelines and detailed information about registered pesticide products, tolerances, and labels.

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State Registration of Pesticides

After a pesticide is registered by EPA, states can register pesticides under specific state pesticide registration laws. A state Exit EPA disclaimer may have more stringent requirements for registering pesticides for use in that state. Pesticide registrants should consult with the appropriate state pesticide program for questions about state registration. Ultimately, states have primary responsibility (called primacy) for pesticides used within state borders.

Special Local Needs - States may register an additional use of a federally registered pesticide product or a new end-use product to meet special local needs. EPA reviews these registrations and may disapprove them under certain circumstances.

The Guidance Document on Special Local Needs State Registrations provides guidance for the registration of an additional or new use of a pesticide product under the special local needs provision as stated in Section 24(c) of FIFRA.

Emergency Exemptions - Section 18 of FIFRA authorizes EPA to allow States to use a pesticide for an unregistered use for a limited time if EPA determines that emergency conditions exist.

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