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Reilly, Ph.D. Chief, Biochemical Pesticides Branch reilly.sheryl@epa.govPUZ&H?+U.S. EPA Office of Pesticide Programs (OPP),,$Authorized by law to regulate pesticides to ensure that their use does not cause unreasonable adverse effects to humans or the environment  LEGAL AUTHORITY$j Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Federal Food, Drug, and Cosmetic Act (FFDCA)6 j  j % ; FIFRA vs. FFDCAFIFRA 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 (]((j( ] j Food Toleranceo The acceptable maximum residues of a pesticide chemical allowable in or on food and animal feed commodities6o l$ "Food Quality Protection Act (FQPA)2#$$+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 L%))% <, 7Biopesticides and Pollution Prevention Division (BPPD)88$ +Created as a pilot program in 1994 Organized to review & register biopesticides Foster safer pesticide use through the Pesticide Environmental Stewardship Program (PESP)  B [-6Definition 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"!  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 l22FGx:2! 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 pests6 J > >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 speciesV- G 5 -G5 >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 fG !9 ! G:>F .E#>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 ((U       ! F$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 decisionD " 5   y  >Classification of Active Ingredients as Biochemical Pesticides??$i Non-toxic modes of action Growth/development changes Lures/Attractants/Repellents Irritants Suffocation d N $N>Classification of Active Ingredients as Biochemical Pesticides??$Four Biologically Functional Classes - Semiochemicals - Natural Plant Growth Regulators - Natural Insect Growth Regulators - Enzymes<% w!, p*^#Data Requirements for Biopesticides$$$@Reduced data requirements for biopesticides (relative to conventional chemical pesticides) 40 CFR 158.690  lists data requirements for biochemical pesticides 4  ,tG%"Data Requirements for Registration##$Regulations Explain how the Agency interprets the intent of the laws under their authority 40 CFR 150 to 189 for pesticides Guidelines Protocols for studies needed to generate data to assess human and environmental risks www.epa.gov/pesticides/biopesticides  ,ZP,Z!,Z ,ZV,Z&-Z P!   V&!0H&9Human Health Data Requirements for Biochemical Pesticides::$ 3-tiered system of testing & maximum hazard approach to risk assessment Focus on studies needed to conduct risk assessments ZH$Z%Z6$ZZ| 3Product Characterization for Biochemical Pesticides44${Product & active ingredient Identity, Physical/Chemical Properties Analysis and Certified Limits Manufacturing Process 2w w %Tier I Human Health Data Requirements&&$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 TGAIh  -Tier I Human Health Data Requirements (cont.)..$Study Type Test Substance 90 day feeding TGAI 90 day dermal TGAI 90 day inhalation TGAI Developmental toxicity (1 species) TGAI Hypersensitivity incidents - reports from useh  1Toxicology/Human Health Data Requirements (cont.)22$TIER II Study Type Test Substance Mammalian mutagenicity TGAI Immune response TGAI TIER III Chronic exposure TGAI Oncogenicity TGAI  4 /i,-<SNon-Target Organism/Ecological Effects Data Requirements for Biochemical PesticidesTT 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 #   ['I ;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| ' d   'd#SUMMARYOPP 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 $tSUMMARY: Case x Case =  Norm for Biochemical Pesticides;;$z 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 Z[,ZE,Z,Z-Z[ E  /&'()*+./1 3 4 5 6 789:<=?BCDIJKLPbq ` ` ̙33` 333MMM` ff3333f` f` f` 3>?" dd@(?$Kd@  d @  ` n?" dd PR    @ ` ` p>> xx1(    HA ?1?p!X $0!0  HA ?1?P :8X $0!028 pH upHt  S DBHC DE\Fd1? 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K  S xK ?  K -FIFRA defines a pesticide as 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 &H  0޽h ? a(f 0 &`(  X  C !   M  S DM ?  M @There are two general categories of pesticides that are regulated by the EPA, the conventional chemical pesticides, which usually have a toxic mode of action on the target pest, and the biopesticides. Biopesticides are usually inherently less toxic to non-target species, including humans, than conventional pesticides. (Awf3,  kH  0޽h ? a(8!0 (  X  C !   M  S M ?  M  Biopesticides are derived from such natural materials as animals, plants, bacteria, and certain minerals. At the end of 2001, there were approximately 195 registered biopesticide active ingredients and 780 products. In the U.S., biopesticides fall into three major classes: Biochemical pesticides  naturally occurring substances that control pests by non_toxic mechanisms, Microbial pesticides consist of a microorganism (e.g., a bacterium, fungus, virus or protozoan) as the active ingredient. Microbial pesticides can control many different kinds of pests, although each separate active ingredient is relatively specific for its target pest[s]. For example, there are fungi that control certain weeds, and other fungi that kill specific insects. The most widely used microbial pesticides are subspecies and strains of Bacillus thuringiensis, or Bt. Each strain of this bacterium produces a different mix of proteins, and specifically kills one or a few related species of insect larvae. While some Bts control moth larvae found on plants, others target the larvae of flies and mosquitoes. The target insect species are determined by whether the particular Bt produces a protein that can bind to a larval gut receptor, thereby causing the insect larvae to starve Plant_Incorporated_Pro