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Office of Pesticide ProgramsBiopesticides and Pollution Prevention Division
Sheryl K. Reilly, Ph.D.Chief, Biochemical Pesticides Branch
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