1. 1 Office of Pesticide Programs Biopesticides and Pollution Prevention Division Sheryl K. Reilly, Ph.D. Chief, Biochemical Pesticides Branch reilly.sheryl@epa.gov Regulation of Biochemical Pesticides Under FIFRA and FFDCA/FQPA

2. 2 U.S. EPA Office of Pesticide Programs (OPP) Authorized by law to regulate pesticides to ensure that their use does not cause unreasonable adverse effects to humans or the environment

3. 3 LEGAL AUTHORITY Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Federal Food, Drug, and Cosmetic Act (FFDCA)

4. 4 FIFRA vs. FFDCA $FIFRA –Risk v. benefit must be considered –“prevent unreasonable adverse effects on the environment” $FFDCA –“reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue”

5. 5 Food Tolerance The acceptable maximum residues of a pesticide chemical allowable in or on food and animal feed commodities

6. 6 Food Quality Protection Act (FQPA) Amended FIFRA and FFDCA to consider: Relationship of animal studies to human risks Dietary consumption patterns Cumulative effects of chemicals with similar mode of action/toxicity Aggregate exposure (dietary, occupational, etc.) Variablity of subgroups (infants and children) Endocrine disruptors

7. 7 Biopesticides and Pollution Prevention Division (BPPD) $ Created as a pilot program in 1994 $ Organized to review & register biopesticides $ Foster safer pesticide use through the Pesticide Environmental Stewardship Program (PESP)

8. 8 Definition of a “Pesticide” Any substance or mixture of substances that are intended for preventing, destroying, repelling or mitigating any pest, or intended for use as a plant regulator, defoliant, desiccant or nitrogen stabilizer

9. 9 Classes of Pesticides Designated by the Office of Pesticide Programs: –Chemical or “conventional” pesticides: (usually) toxic mode of action –Biopesticides inherently “safer” (less toxic) than chemical pesticides

10. 10 Biopesticides $ Biochemical - naturally occurring, nontoxic mode of action on target pests $ Microbial - naturally occurring/ genetically engineered microorganisms, may be toxic to target pests $ Plant Incorporated Protectants - genetically engineered plants, may be toxic to target pests

11. 11 Classification of Active Ingredients as Biochemical Pesticides $ Natural occurrence $ Non-toxic mode of action –against the target pest –does not presume a lack of mammalian toxicity $ Low application rates $ Narrow range of target species

12. 12 Classification of Active Ingredients as Biochemical Pesticides $ “Naturally occurring” does not always mean a non-toxic mode of action –Pyrethrins –Antibiotics from microorganisms –Heavy metals

13. 13 Classification of Active Ingredients as Biochemical Pesticides $A synthetic active ingredient can be classified as a biochemical pesticide if it is structurally similar & functionally identical to the naturally occurring a.i. –Example: Pheromones

14. 14 Mode of Action ? Registrant submits information on mode of action (on target pest) of the active ingredient they want to register The best available scientific information is applied to make a decision

15. 15 Classification of Active Ingredients as Biochemical Pesticides $ Non-toxic modes of action –Growth/development changes –Lures/Attractants/Repellents –Irritants –Suffocation

16. 16 Classification of Active Ingredients as Biochemical Pesticides $ Four Biologically Functional Classes - Semiochemicals - Natural Plant Growth Regulators - Natural Insect Growth Regulators - Enzymes

17. 17 Data Requirements for Biopesticides $ Reduced data requirements for biopesticides (relative to conventional chemical pesticides) $ 40 CFR 158.690 – lists data requirements for biochemical pesticides

18. 18 Data Requirements for Registration $Regulations –Explain how the Agency interprets the intent of the laws under their authority  40 CFR 150 to 189 for pesticides $Guidelines –Protocols for studies needed to generate data to assess human and environmental risks www.epa.gov/pesticides/biopesticides

19. 19 Human Health Data Requirements for Biochemical Pesticides $ 3-tiered system of testing & maximum hazard approach to risk assessment $ Focus on studies needed to conduct risk assessments

20. 20 Product Characterization for Biochemical Pesticides $ Product & active ingredient Identity, Physical/Chemical Properties $ Analysis and Certified Limits $ Manufacturing Process

21. 21 Tier I Human Health Data Requirements Study Type Test Substance Acute oral toxicity TGAI / EP Acute dermal toxicity TGAI / EP Acute inhalation toxicity TGAI / EP Eye Irritation EP Dermal irritationEP HypersensitivityEP GenotoxicityTGAI

22. 22 Tier I Human Health Data Requirements (cont.) Study Type Test Substance 90 day feeding TGAI 90 day dermal TGAI 90 day inhalation TGAI Developmental toxicity (1 species)TGAI Hypersensitivity incidents - reports from use

23. 23 Toxicology/Human Health Data Requirements (cont.) TIER II Study TypeTest Substance Mammalian mutagenicityTGAI Immune responseTGAI TIER III Chronic exposureTGAI OncogenicityTGAI

24. 24 Non-Target Organism/Ecological Effects Data Requirements for Biochemical Pesticides TIER I Study Type Test Substance Avian acute oral toxicity TGAI Avian dietary toxicity TGAI Freshwater fish LC 50 TGAI Freshwater invertebrate LC 50 TGAI Non-target plant TGAI Non-target insect TGAI

25. 25 Biochemical Pesticides Exempted from Regulation Under FIFRA 40 CFR 152.25 $ Pheromones –produced by arthropods & used in traps $ Vitamin-hormone products $ Foods which attract pests but do not contain active pesticidal ingredients

26. 26 SUMMARY $ OPP recognizes that certain pesticide active ingredients require less data to support a finding of no significant adverse effects to humans and the environment $ Renewed interest in biochemical pesticides $ Initiatives by EPA to provide regulatory relief

27. 27 SUMMARY: Case x Case = “Norm” for Biochemical Pesticides $Standard guideline studies req’d for some pesticides $Scientific literature o.k. for others –Surrogate data considered (similar structure/activity relationships) $Waivers of data considered