Office of Pesticide Programs Biopesticides and Pollution Prevention Division

1. Office of Pesticide ProgramsBiopesticides 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. 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. LEGAL AUTHORITY Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Federal Food, Drug, and Cosmetic Act (FFDCA)

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

6. FoodQuality 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. 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. 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. 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. 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. 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. 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. Classification of Active Ingredients as Biochemical Pesticides • A synthetic active ingredient can be classified as a biochemical pesticide if it is structurallysimilar & functionally identical to the naturally occurring a.i. • Example: Pheromones

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

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

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

21. Tier I Human Health Data Requirements Study TypeTest Substance Acute oral toxicity TGAI / EP Acute dermal toxicity TGAI / EP Acute inhalation toxicity TGAI / EP Eye Irritation EP Dermal irritation EP Hypersensitivity EP Genotoxicity TGAI

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

23. Toxicology/Human Health Data Requirements (cont.) TIER II Study Type Test Substance Mammalian mutagenicity TGAI Immune response TGAI TIER III Chronic exposure TGAI Oncogenicity TGAI

24. Non-Target Organism/Ecological Effects Data Requirements for Biochemical Pesticides TIER I Study TypeTest Substance Avian acute oral toxicity TGAI Avian dietary toxicity TGAI Freshwater fish LC50 TGAI Freshwater invertebrate LC50 TGAI Non-target plant TGAI Non-target insect TGAI

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. 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. 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