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Office of Pesticide Programs Biopesticides and Pollution Prevention Division

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... and Rodenticide Act (FIFRA) Federal Food, Drug, ... of animal studies to human risks Dietary ... for Registration Regulations Explain how the ... – PowerPoint PPT presentation

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Title: Office of Pesticide Programs Biopesticides and Pollution Prevention Division


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

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
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
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 structurally
    similar 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 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

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
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 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

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 reqd for some
    pesticides
  • Scientific literature o.k. for others
  • Surrogate data considered (similar
    structure/activity relationships)
  • Waivers of data considered
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