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Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops (2011) / Chapter Skim
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Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V
Pages 158-170

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From page 158...
... Appendix B EPA Requirements and Guidelines under 40 CFR 158, Subpart V TABLE B-1 Microbial Pesticides Product Analysis Data Requirements Guideline All Use Test Substance Test Number Data Requirement Patterns MP EP Notesa Product Chemistry and Composition 885.1100 Product Identity R MP EP -- 885.1200 Manufacturing process R TGAI TGAI -- and MP and EP Deposition of a sample in a R TGAI TGAI -- nationally recognized culture collection 885.1300 Discussion of formation of R TGAI TGAI -- unintentional ingredients and MP and EP Analysis and Certified Limits 885.1400 Analysis of samples R TGAI TGAI 1 and MP and EP 885.1500 Certification of limits R MP EP -- Physical and Chemical Characteristics 830.6302 Color R TGAI TGAI -- 830.6303 Physical state R TGAI TGAI -- 830.6304 Odor R TGAI TGAI -- 830.6313 Stability to normal and elevated R TGAI TGAI -- temperatures, metals and metal ions 830.6317 Storage stability R TGAI TGAI -- and MP and EP 830.6319 Miscibility R MP EP 2 830.6320 Corrosion Characteristics R MP EP 3 830.7000 pH R TGAI TGAI -- (Continued)
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From page 159...
... Source: CFR 40 Part 158 Subpart V TABLE B-2 Microbial Pesticides Residue Data Requirements Guideline All Use Test Substance Data Test Number Data Requirement Patterns to Support MP or EP Notesa 885.2100 Chemical Identity CR EP 1 885.2200 Nature of the Residue in plants CR EP 1 885.2250 Nature of the Residue in animals CR EP 1 885.2300 Analytical methods – plants CR TGAI 1 885.2350 Analytical methods – animals CR TGAI 1 885.2400 Storage Stability CR EP 1 885.2500 Magnitude of residue in plants CR EP 1 885.2550 Magnitude of residues in meat, milk, CR EP 1 poultry, eggs 885.2600 Magnitude of residues in potable water, CR EP 1 fish, and irrigated crops Abbreviations: CR, conditionally required; EP, end-use product; TGAI, technical grade of the active ingredient.
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From page 160...
... 885.3400 Hypersensitivity incidents R All 3 885.3500 Cell culture R TGAI 4 870.1100 Acute oral toxicity R MP , EP 1, 5 870.1200 Acute dermal toxicity R MP , EP 5 870.1300 Acute inhalation toxicity R MP , EP 5, 6 870.2400 Acute eye irritation R MP , EP 5 870.2500 Primary dermal irritation R MP , EP 5 Tier II 885.3550 Acute toxicology CR TGAI 7 885.3600 Subchronic toxicity/pathogenicity CR TGAI 8 Tier III 885.3650 Reproductive fertility effects CR TGAI 9, 13 870.4200 Carcinogenicity CR TGAI 10, 13 870.7800 Immunotoxicity CR TGAI 11, 13 885.3000 Infectivity/pathogenicity analysis CR TGAI 12, 13 Abbreviations: CR, conditionally required; EP, end-use product; MP, manufacturing-use product; R, required; TGAI, technical grade of the active ingredient a Test notes. The following test notes are applicable to the data requirements for microbial pesticides toxicology as referenced in the last column of the table contained in paragraph (c)
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From page 161...
... 12. An analysis of human infectivity/pathogenicity potential using scientific literature, genomic analysis, and/or actual specific cell culture/animal data may be required for products known to contain or suspected of containing intracellular parasites of mammalian cells for products that exhibit pathogenic characteristics in Tier I and/or Tier II, for products which are closely related to known human pathogens based on the product analysis data, or for known human pathogens that have been "disarmed" or rendered nonpathogenic for humans.
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From page 162...
... 162 TABLE B-4 Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements Use Patterns Aquatic Terrestrial Food/ Residential Greenhouse Indoor Guideline Feed/ Food/ Food/ Test Test Number Data Requirement Food/Feed Nonfood Nonfood Forestry Outdoor Nonfood Nonfood Industrial Substance Notesa Tier I 885.4050 Avian oral toxicity R R R R R CR CR CR TGAI 1, 2 885.4100 Avian inhalation CR CR CR CR CR CR CR CR TGAI 1, 2, 3 toxicity/pathogenicity 885.4150 Wild mammal CR CR CR CR CR NR NR CR TGAI 1, 4 toxicity/pathogenicity 885.4200 Freshwater fish R R R R CR CR CR CR TGAI 1, 2, 5 toxicity/ pathogenicity or TEP 885.4240 Freshwater invertebrate R R R R CR CR CR CR TGAI 1, 2, 5 toxicity/pathogenicity or TEP 885.4280 Estuarine/Marine CR CR CR CR CR NR NR CR TGAI 1, 6 fish testing Estuarine and marine invertebrate testing 885.4300 Nontarget plant CR CR CR R CR NR CR CR TEP 1, 7 testing 885.4340 Nontarget insect R R R R R CR NR CR TGAI 1, 8 testing 885.4380 Honey bee R R R R R CR NR CR TGAI 1 testing
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From page 163...
... Tier II 885.5200 Terrestrial CR CR CR CR CR NR NR CR TGAI 9 environmental or TEP expression tests 885.5300 Freshwater CR CR CR CR CR NR NR CR TGAI 10 environmental or TEP expression tests 885.5400 Marine or estuarine CR CR CR CR CR NR NR CR TGAI 11, 12 environmental or TEP expression tests Tier III 885.4600 Avian chronic CR CR CR CR CR NR NR CR TGAI 12, 13 pathogenicity and reproduction test 885.4650 Aquatic invertebrate CR CR CR CR CR NR NR CR TGAI 12, 14 range testing 885.4700 Fish life cycle studies CR CR CR CR CR NR NR CR TGAI 12, 14 885.4750 Aquatic ecosystem test CR CR CR CR CR NR NR CR TGAI 15 Tier IV 850.2500 Field testing for CR CR CR CR CR NR NR CR TGAI 11, 16 850.1950 terrestrial wildlife or TEP and Field testing for aquatic organisms 850.2500 Simulated or actual CR CR CR CR CR NR NR CR TEP 16, 17, 20 field tests (birds, mammals) (Continued)
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From page 164...
... The following test notes are applicable to the data requirements for microbial pesticides nontarget organism and environmental fate as referenced in the last column of the table contained in paragraph (d) of this section.
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From page 165...
... are reported in one or more Tier I tests and results of Tier II tests indicate exposure of the microbial agent to the affected nontarget terrestrial wildlife or aquatic organisms. The protocols for these tests may have to be modified in accordance with results from the nontarget organism and environmental expression studies.
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From page 166...
... Pathogenic effects observed at actual or expected field residue exposure levels are reported in Tier III; and ii. The Agency determines that quarantine methods would not prevent the microbial pesticide from contaminating areas adjacent to the test area.
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From page 167...
... TABLE B-5 Series 885 -- Microbial Pesticide Test Guidelines as of January 2010 OPPTS Other Reference Numbers Guideline EPA Pub Date Number Guideline Names OPPT OPP OECD Number Issued Final 885 Test Guidelines 885.0001 Overview for Microbial Pest Control Agents none 150A none 712-C-96-280 Feb-96 Group A -- Product Analysis Test Guidelines 885.1100 Product Identity none 151A-10 none 712-C-96–273 Feb-96 885.1200 Manufacturing Process none 151A-11 none 712-C-96–293 Feb-96 885.1300 Discussion of Formation of Unintentional Ingredients none 151A-01 none 712-C-96–294 Feb-96 885.1400 Analysis of Samples none 151A-13 none 712-C-96-295 Feb-96 885.1500 Certification of Limits none 151A-15 none 712-C-96-296 Feb-96 Group B -- Residues Test Guidelines 885.2000 Background for Residue Analysis of Microbial Pest Control Agents none 153A-1 none 712-C-96-299 Feb-96 885.2100 Chemical Identity none 153A-4 none 712-C-96-300 Feb-96 885.2200 Nature of the Residue in Plants none 153A-6 none 712-C-96–302 Feb-96 885.2250 Nature of the Residue in Animals none 153A-7 none 712-C-96–303 Feb-96 885.2300 Analytical Methods -- Plants none 153A-8a none 712-C-96-304 Feb-96 885.2350 Analytical Methods -- Animals none 153A-8b none 712-C-96-305a Feb-96 885.2400 Storage Stability none 153A-9 none 712-C-96-306 Feb-96 885.2500 Magnitude of Residues in Plants none 153A-10 none 712-C-96-307 Feb-96 885.2550 Magnitude of Residues in Meat, Milk, Poultry, Eggs none 153A-11 none 712-C-96-308 Feb-96 885.2600 Magnitude of Residues in Potable Water, Fish, and Irrigated Crops none 153A-01 none 712-C-96–309 Feb-96 (Continued)
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From page 168...
... 168 TABLE B-5 Continued OPPTS Other Reference Numbers Guideline EPA Pub Date Number Guideline Names OPPT OPP OECD Number Issued Group C -- Toxicology Test Guidelines 885.3000 Background–Mammalian Toxicity/Pathogenicity/Infectivity none 152A-1 none 712-C-96–314 Feb-96 885.3050 Acute Oral Toxicity/Pathogenicity none 152A-10 none 712-C-96–315 Feb-96 885.3100 Acute Dermal Toxicity/Pathology none 152A-11 none 712-C-96-316 Feb-96 b 885.3150 Acute Pulmonary Toxicity/Pathogenicity none 152A-12 none 712-C-96-317 Feb-96 885.3200 Acute Injection Toxicity/Pathogenicity none 152A-13 none 712-C-96-318 Feb-96 885.3400 Hypersensitivity Incidents none 152A-15 none 712-C-96-320 Feb-96 885.3500 Cell Culture none 152A-16 none 712-C-96-321 Feb-96 885.3550 Acute Toxicology, Tier II none 152A-20 none 712-C-96-322 Feb-96 885.3600 Subchronic Toxicity/Pathogenicity none 152A-21 none 712-C-96-323c Feb-96 885.3650 Reproductive/Fertility Effects none 152A-30 none 712-C-96-324 Feb-96 Group D -- Nontarget Organism and Environmental Expression Test Guidelines 885.4000 Background for Nontarget Organism Testing of Microbial none 154A-1, none 712-C-96-328 Feb-96 Pest Control Agents 154A-2, 154A-3, 154A-4, 154A-5 885.4050 Avian Oral, Tier I none 154A-16 none 712-C-96-329 Feb-96 885.4100 Avian Inhalation Test, Tier I none 154A-17 none 712-C-96-330 Feb-96 885.4150 Wild Mammal Testing, Tier I none 154A-18 none 712-C-96-331 Feb-96 885.4200 Freshwater Fish Testing, Tier I none 154A-19 none 712-C-96-332 Feb-96
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From page 169...
... c Document incorrectly says publication Number ends in "-232". Source: CFR 40 Part 158 Subpart V
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Key Terms

  • data requirements
  • microbial pesticide
  • tier iii
  • acute oral
  • data requirement

  • pest control
  • microbial pest
  • following test
  • nontarget plant
  • active ingredient

  • pathogenic effects
  • technical grade
  • table contained
  • test substance
  • avian inhalation

  • avian chronic
  • environmental expression
  • test notes
  • requirements guideline
  • preferred species

  • conditionally required
  • plant studies
  • product analysis
  • control agents
  • oral toxicity

  • expression test
  • microbial agent
  • storage stability
  • pesticides nontarget
  • human pathogens


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