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

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

3. 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. 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. 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. 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. 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. 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. 9 PESTICIDE REGISTRATION EFFICACY DATA EPA Office of Pesticide Programs (OPP) sets test data & performance standards

10. 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. 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. 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. 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. 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. 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. 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. 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

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