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Office of Pesticide ProgramsBiopesticides and Pollution Prevention Division

Sheryl K. Reilly, Ph.D.Chief, Biochemical Pesticides Branch

reilly.sheryl@epa.gov

Regulation of Biochemical Regulation of Biochemical Pesticides Under FIFRA and Pesticides Under FIFRA and

FFDCA/FQPAFFDCA/FQPA

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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

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LEGAL AUTHORITY

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

Federal Food, Drug, and Cosmetic Act (FFDCA)

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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”

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Food Tolerance

The acceptable maximum residues of a pesticide chemical

allowable in or on food and animal feed commodities

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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

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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)

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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

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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

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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

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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

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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

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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

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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

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Classification of Active Ingredients as Biochemical Pesticides

$ Non-toxic modes of action– Growth/development changes– Lures/Attractants/Repellents– Irritants– Suffocation

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Classification of Active Ingredients as Biochemical Pesticides

$ Four Biologically Functional Classes

- Semiochemicals

- Natural Plant Growth Regulators

- Natural Insect Growth Regulators

- Enzymes

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Data Requirements for Biopesticides

$ Reduced data requirements for biopesticides (relative to conventional chemical pesticides)

$ 40 CFR 158.690 – lists data requirements for biochemical pesticides

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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

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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

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Product Characterization for Biochemical Pesticides

$ Product & active ingredient Identity, Physical/Chemical Properties

$ Analysis and Certified Limits$ Manufacturing Process

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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 irritation EP

Hypersensitivity EP

Genotoxicity TGAI

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Tier I Human Health Data Requirements (cont.)

Study Type Test Substance90 day feeding TGAI

90 day dermal TGAI

90 day inhalation TGAI

Developmental toxicity

(1 species) TGAI

Hypersensitivity incidents - reports from use

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Toxicology/Human Health Data Requirements (cont.)

TIER IIStudy Type Test Substance

Mammalian mutagenicity TGAI

Immune response TGAI

TIER III

Chronic exposure TGAI

Oncogenicity TGAI

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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 LC50 TGAI

Freshwater invertebrate LC50 TGAI

Non-target plant TGAI

Non-target insect TGAI

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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

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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

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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