Pesticides: Registration and labeling

Scope

The process of registering a pesticide is a scientific, legal, and administrative procedure where EPA examines the ingredients of the pesticide; the particular site or crop where it is to be used; the amount, frequency, and timing of its use; and storage and disposal practices.

Regulatory citations

• 40 CFR 152 — Pesticide Registration and Classification Procedures

Key definitions

• Active ingredient: The ingredient that prevents, destroys, repels, or mitigates a pest, or is a plant regulator, defoliant, desiccant, or nitrogen stabilizer.
• Applicant: A person who applies for a registration or amended registration under FIFRA.
• Distribute or sell: The acts of distributing, selling, offering for sale, holding for sale, shipping, holding for shipment, delivering for shipment, or receiving and (having so received) delivering or offering to deliver, or releasing for shipment to any person in any state.
• End use product: A pesticide product whose labeling:
  1. Includes directions for use of the product (as distributed or sold, or after combination by the user with other substances) for controlling pests or defoliating, desiccating, or regulating the growth of plants, and
  2. Does not state that the product may be used to manufacture or formulate other pesticide products.

• Establishment: Any site where a pesticide product, active ingredient, or device is produced, regardless of whether:
  • The site is independently owned or operated;
  • The site is domestic (i.e., located in the United States) and is producing the pesticide or device only for export; or
  • The site is located in a foreign country and is producing the pesticide or device for importation into the United States.
• FIFRA: The Federal Insecticide, Fungicide, and Rodenticide Act, as amended.
• Final printed labeling: The label or labeling of the product when distributed or sold. Final printed labeling does not include the package of the product, unless the labeling is an integral part of the package.
• Inert ingredients: Ingredients in a pesticide that do not act as active ingredients.
• Package or packaging: The immediate container or wrapping, including any attached closure(s), in which the pesticide is contained for distribution, sale, consumption, use, or storage. The term does not include any shipping or bulk container used for transporting or delivering the pesticide unless it is the only such package.
• Pesticide: Any substance or mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant.
• Pesticide Registration Improvement Act (PRIA 3): The Pesticide Registration Improvement Act of 2003 (PRIA), which amended FIFRA and FFDCA. PRIA was reauthorized by the Pesticide Registration Improvement Renewal Act of 2007 and the Pesticide Registration Improvement Extension Act of 2012. Under PRIA 3:
  • Companies must pay service fees according to the category of the registration action.
  • EPA must meet decision review time periods, which result in a more predictable evaluation process for companies.
  • Shorter decision review periods are provided for reduced-risk registration applications.
• Produce: To manufacture, prepare, propagate, compound, or process any pesticide, including any pesticide produced pursuant to an Experimental Use Permit, any active ingredient or device, or to package, repackage, label, relabel, or otherwise change the container of any pesticide or device.
• Registrants: People and companies who have registered any pesticide in compliance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
• Registration: A license EPA grants to manufacturers to make and sell certain pesticides

Summary of requirements

• Submit a Pesticide Registration Notice to begin the process of registering your new pesticide, new formula, or new use for an existing pesticide.
• Complete and submit an original Application for Pesticide Registration/Amendment form.
• Pay fees when you submit your application.
• Obtain an EPA Company Number before submitting your first product with EPA.
• For subsequent registrations, refer to the existing company number.
• Pesticide producers who plan to register their own products must obtain an EPA Establishment Number (using EPA Form 3540-8.)
• Submit your master label to EPA for review and approval.