EPA’S PESTICIDE REGISTRATION PROGRAM

1. EPA’S PESTICIDE REGISTRATION PROGRAM Eugene Thilsted Strategic Agriculture Initiative Coordinator Environmental Protection Agency – Region 6 Dallas, TX 75202 January 27, 2004

2. OVERVIEW • Definitions and Framework • Pesticide Registration • Crisis Exemptions • Devices • Take Home Messages

3. FIFRA DEFINITIONS • The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) says: • A pesticide is any substance intended to prevent, destroy, repel or mitigate any pest, but not drugs or liquid medical device sterilants. • A pest is any form of plant or animal life or virus, bacteria, or other microorganism, except on or in living man or animals.

4. FIFRA DEFINITIONS • An antimicrobial pesticide is any substance intended to kill microorganisms or protect inanimate objects from contamination or fouling by microorganisms. • A pesticide device is a mechanical or physical contrivance intended to prevent or kill any pest.

5. FIFRA FRAMEWORK Prior to sale or distribution, a pesticide product must be EITHER: • Registered by EPA (Sec. 3), OR • Granted an exemption (Sec. 18) • Specific exemption • Public health exemption • Crisis exemption

6. FIFRA FRAMEWORK • The only exception to registration or exemption under FIFRA is laboratory testing to generate data to support a registration or exemption • Field tests for pesticidal purposes need an exemption (see next slide).

7. FIFRA FRAMEWORK • Field tests for pesticidal purposes need an exemption. • Exception: conducting experimental field tests of new pesticides or new uses of pesticides on 10 acres or more land or one acre or more of water (an EUP – Section 5 is required).

8. PESTICIDE REGISTRATION (FIFRA Sec. 3) • Companies must develop their own data and submit applications for registration • Product labeling and required data accompany the application • Registration may be for new product or amending existing product

9. PESTICIDE REGISTRATIONEFFICACY DATA EPA Office of Pesticide Programs (OPP) sets test data & performance standards

10. CRISIS EXEMPTION PROCESS (FIFRA Sec. 18) • EPA set up expedited process to issue crisis exemptions – permits the unregistered use of a pesticide in a specific geographic area for a limited time if emergency pest conditions exist. • Requests may come from federal, state or local agencies, companies, or registrants

11. CRISIS EXEMPTION PROCESS (FIFRA Sec. 18) • Requests must submit/cite efficacy data and describe exactly how product will be used • Usually growers and others encounter a pest problem in which there is no registered pesticide available.

12. CRISIS EXEMPTIONS • Requests must contain a site-specific remediation plan • EPA reviews requests to assure that a product will be effective and safe for the proposed use • Request needs to address any safety or environmental issues

13. CRISIS EXEMPTION EFFICACY DATA • Efficacy data must provide scientific evidence that the product will control the specific pest in which the Section 18 crisis was submitted

14. CRISIS EXEMPTIONS State-Specific Registrations Section 24C • States can register a new pesticide product for any use (or an additional use) as long as there is both a demonstrated “special local need” and a tolerance, exemption from a tolerance, or other clearance under FFDCA

15. DEVICE • Means any instrument (other than a firearm) which is intended for trapping, destroying, repelling, or mitigating any pest or any other form of plant or animal life (other than man, bacteria, virus, etc.). • Does not include equipment used for the application of pesticides when sold separately.

16. TAKE HOME MESSAGES • Pesticides must have a registration or exemption prior to sale or distribution • Requests for crisis exemptions along with data, labeling and plans must be submitted to EPA/OPPTS

17. FOR MORE INFORMATION VISIT www.epa.gov/pesticides www.epa.gov/pesticides/factssheets/registration.htm Or: call the EPA Office of Pesticide Programs – Registration Ombudsperson Linda Arrington – 703-305-5446