Appendix B

EPA Requirements and Guidelines
under 40 CFR 158, Subpart V

TABLE B-1 Microbial Pesticides Product Analysis Data Requirements Test Substance

Guideline Number Data Requirement All Use Patterns Test Substance Test Notesa
MP EP
Product Chemistry and Composition
885.1100 rtodua Identity R MP HP
885.1200 Manufacturing process R TGAI and MP TGAI andEP
Deposition of a sample in a nationally recognized culture collection R TGAI TGAI
885.1300 Discussion of formation of uaorsanoml inEedients R TGAI and MP TGAI andEP
Analysis and Certified Limits
885.1400 Analysis of samples R TGAI and MP TGAI andEP 1
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 temperatures, metals and metal ions R TGAI TGAI
830.6317 Storage stability R TGAI and MP TGAI andEP
830.6319 Miscibility R MP EP 2
830.6320 Corrosion Characteristics R MP EP 3
830.7000 pH R TGAI TGAI


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Appendix B EPA Requirements and Guidelines under 40 CFR 158, Subpart V TABLE B-1 Microbial Pesticides Product Analysis Data Requirements Test Substance Guideline All Use Test Notesa Number Data Requirement Patterns MP EP 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) 158

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159 Appendix B TABLE B-1 Continued Test Substance Guideline All Use Test Notesa Number Patterns Data Requirement MP EP Physical and Chemical Characteristics 830.7100 Viscosity R MP EP 4 830.7300 Density/relative density/bulk R TGAI TGAI — density (specific gravity) Abbreviations: 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 product analysis as referenced in the last column of the table contained in paragraph (c) of this section. 1. Required to support registration of each manufacturing-use product and end-use prod- uct. This analysis must be conducted at the point in the production process after which there would be no potential for microbial contamination or microbial regrowth. For full registration, generally an analysis of samples is a compilation of batches, over a period of time, depending on the frequency of manufacturing. 2. Only required for emulsifiable liquid forms of microbial pesticides. 3. Required when microbial pesticides are packaged in metal, plastic, or paper containers. 4. Only required for liquid forms of microbial pesticides. Source: CFR 40 Part 158 Subpart V. TABLE B-2 Microbial Pesticides Residue Data Requirements Guideline All Use Test Substance Data Test Notesa Data Requirement Number Patterns to Support MP or EP 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. a Test notes. The following test note is applicable to the data requirements for microbial pesticides residue as referenced in the last column of the table contained in paragraph (c) of this section. 1. Required when the results of testing: i. Indicate the potential to cause adverse human health effects or the product charac- terization indicates the microbial pesticide has a significant potential to produce a mammalian toxin; and ii. The use pattern is such that residues may be present in or on food or feed crops. Source: CFR 40 Part 158 Subpart V.

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160 Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops TABLE B-3 Microbial Pesticides Toxicology Data Requirements Guideline All Use Test Test Notesa Number Data Requirement Patterns Substance Tier I 885.3050 Acute oral toxicity/pathogenicity R TGAI 1 885.3150 Acute pulmonary toxicity/pathogenicity R TGAI — 885.3200 Acute injection R TGAI 2 toxicity/pathogenicity/(intravenous) Acute injection toxicity/pathogenicity/(intraperitoneal) 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) of this section: 1. The acute oral toxicity/pathogenicity study is required to support the TGAI. However, it can be combined with the unit dose portion of the acute oral toxicity study, with an EP or MP test material to fulfill the requirement for the TGAI and the MP or EP in a single study, if the new protocol is designed to address the endpoints of concern. 2. Data not required for products whose active ingredient is a virus. For test materials whose size or consistency may prevent use of an intravenous injection, the intraperitoneal injection procedure may be employed. 3. Hypersensitivity incidents, including immediate type and delayed-type reactions of humans or domestic animals, occur during the testing or production of the TGAI, MP, or EP, or are otherwise known to the applicant must be reported if they occur. 4. Data must be submitted only for products whose active ingredient is a virus. 5. The 870 series studies for the MP and EP are intended to provide data on the acute toxicity of the product. Waivers for any or all of these studies may be granted when the applicant can demonstrate that the combination of inert ingredients is not likely to pose any significant human health risks. Where appropriate, the limit dose approach to testing is recommended.

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161 Appendix B 6. Required when the product consists of, or under conditions of use would result in, an inhalable material (e.g., gas, volatile substances, or aerosol particulate). 7. Data required when significant toxicity, in the absence of pathogenicity and significant infectivity, is observed in acute oral, injection, or pulmonary studies (Tier I). Route(s) of exposure correspond to route(s) where toxicity was observed in Tier I studies. The toxic component of the TGAI is to be tested. 8. Data required when significant infectivity and/or unusual persistence is observed in the absence of pathogenicity or toxicity in Tier I studies. Routes of exposure (oral and/or pulmonary) correspond to routes in Tier I studies where adverse effects were noted. Data may also be required to evaluate adverse effects due to microbial contaminants or to toxic byproducts. 9. Data are required when one or more of the following criteria are met: i. Significant infectivity of the microbial pest control agent (MPCA) was observed in test animals in the Tier II subchronic study and in which no significant signs of toxic- ity or pathogenicity were observed. ii. The microbial pesticide is a virus which can persist or replicate in mammalian cell culture lines. iii. The microbial pesticide is not amenable to thorough taxonomic classification, and is related to organisms known to be parasitic for mammalian cells. iv. The microbial pesticide preparation is not well purified, and may contain contami- nants which are parasitic for mammals. 10. Data may be required for products known to contain or suspected to contain carcino- genic viruses or for microbial components that are identified as having significant toxic- ity in Tier II testing. 11. Data may be required for products known to contain or suspected to contain viruses that can interact in an adverse manner with components of the mammalian immune sys- tem. 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 mammal- ian 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 non- pathogenic for humans. 13. Test standards may have to be modified depending on the characteristics of the mi- croorganism. Requirements may vary for these studies depending on the active ingredient being tested. Consultation with the Agency is advised before performing these Tier III studies. Source: CFR 40 Part 158 Subpart V.

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162 TABLE B-4 Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements Use Patterns Aquatic Terrestrial Food/ Residential Greenhouse Indoor Guideline Test Test Feed/ Food/ Food/ Substance Notesa Number Data Requirement Food/Feed Nonfood Forestry Industrial Nonfood Outdoor Nonfood Nonfood 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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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) 163

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164 TABLE B-4 Continued Use Patterns Aquatic Terrestrial Food/ Residential Greenhouse Indoor Guideline Test Test Feed/ Food/ Food/ Substance Notesa Number Data Requirement Food/Feed Nonfood Forestry Industrial Nonfood Outdoor Nonfood Nonfood 850.1950 Simulated or actual CR CR CR CR CR NR NR CR TEP 16, 18, field test (aquatic 19, 20 organisms) 850.2500 Simulated or actual CR CR CR CR CR NR NR CR TEP 16, 18, field tests (insect 19, 20 predators, parasites) 850.3040 Simulated or actual CR CR CR CR CR NR NR CR TEP 16, 18, field tests (insect 19, 20 pollinators) 850.4300 Simulated or actual CR CR CR CR CR NR NR CR TEP 16, 18, field tests (plants) 19, 20 Abbreviations: CR, conditionally required; NR, not required; R, required; TEP, typical end-use product; TGAI, technical grade of the active ingredient. a Test notes. 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. 1. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern, production volume, and other pertinent factors. 2. The preferred species for the avian oral study is either the upland game or waterfowl. The preferred species for the avian inhalation toxic- ity/pathogenicity study and the avian chronic toxicity/pathogenicity study is the upland game. There is also the option to test the passerine if there is a concern. The coldwater fish is preferred for freshwater fish testing. However, two species (coldwater and warmwater fish species are the preferred species) must be tested for uses involving direct freshwater exposure. Freshwater invertebrate testing is also required. 3. Data required when the nature of the microbial pesticide and/or its toxins indicates potential pathogenicity to birds. 4. Required on a case-by-case basis if results of tests required by §158.2140 are inadequate or inappropriate for assessment of hazards to wild mammals.

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5. Required when there will be significant exposure to aquatic organisms (fish and invertebrates). 6. Required if the product is intended for direct application into the estuarine or marine environment or expected to enter this environment in significant concentrations because of expected use or mobility pattern. 7. Required if the microbial pesticide is taxonomically related to a known plant pathogen. 8. Data are not required unless an active microbial ingredient controls the target insect pest by a mechanism of infectivity; i.e., may create an epizootic condition in nontarget insects. 9. Required if toxic or pathogenic effects are observed in one or more of the following tests for microbial pesticides: i. Avian acute oral or avian inhalation studies. ii. Wild mammal studies. iii. Nontarget plant studies (terrestrial). iv. Honey bee studies. v. Nontarget insect studies. 10. Required when toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pest control agents: i. Freshwater fish studies. ii. Freshwater invertebrate studies. iii. Nontarget plant studies (aquatic). 11. Required if product is applied on land or in fresh water or marine/estuarine environments and toxic or pathogenic effects are observed in any of the following Tier I tests for microbial pesticides: i. Estuarine and marine animal toxicity and pathogenicity. ii. Plant studies - estuarine or marine species. 12. An appropriate dose-response toxicity test is required when toxic effects on nontarget terrestrial wildlife or aquatic organisms (including plants) 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 ter- restrial wildlife or aquatic organisms. The protocols for these tests may have to be modified in accordance with results from the nontarget or- ganism and environmental expression studies. 13. Required when one or more of the following are present: i. Pathogenic effects are observed in Tier I avian studies. ii. Tier II environmental expression testing indicate that long-term exposure of terrestrial animals is likely. 14. Required when product is intended for use in water or expected to be transported to water from the intended use site, and when pathogenic- ity or infectivity was observed in Tier I aquatic studies. 165

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166 15. Required if, after an analysis of the microbial pesticide's ability to survive and multiply in the environment and what ecological habitat it would occupy, the intended use patterns, and the results of previous nontarget organisms and environmental expression tests, it is determined that use of the microbial agent may result in adverse effects on the nontarget organisms in aquatic environments. Testing is to determine if ap- plications of the microbial pest control would be expected to disrupt the balance of populations in the target ecosystem. 16. Tier IV studies may be conducted as a condition of registration as post-registration monitoring if the potential for unreasonable adverse effects appears to be minimal during that period of use due to implementation of mitigation measures. 17. Required when both of the following conditions occur: i. 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. 18. Short term simulated or actual field studies are required when it is determined that the product is likely to cause adverse short-term or acute effects, based on consideration of available laboratory data, use patterns, and exposure rates. 19. Data from a long-term simulated field test (e.g., where reproduction and growth of confined populations are observed) and/or an actual field test (e.g., where reproduction and growth of natural populations are observed) are required if laboratory data indicate that adverse long-term, cumulative, or life-cycle effects may result from intended use. 20. Since test standards would be developed on a case-by-case basis, consultation with the Agency and development of a protocol is advised before performing these Tier IV studies. Source: CFR 40 Part 158 Subpart V.

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TABLE B-5 Series 885—Microbial Pesticide Test Guidelines as of January 2010 OPPTS Other Reference Numbers EPA Pub Date Guideline Guideline Names Number Issued OPPT OPP OECD Number 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-96 712-C-96-305a 885.2350 Analytical Methods—Animals none 153A-8b none 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) 167

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168 TABLE B-5 Continued OPPTS Other Reference Numbers EPA Pub Date Guideline Guideline Names Number Issued OPPT OPP OECD Number 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-96 712-C-96-323c 885.3600 Subchronic Toxicity/Pathogenicity none 152A-21 none 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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885.4240 Freshwater Aquatic Invertebrate Testing, Tier I none 154A-20 none 712-C-96-333 Feb-96 885.4280 Estuarine and Marine Animal Testing, Tier I none 154A-21 none 712-C-96-334 Feb-96 885.4300 Nontarget Plant Studies, Tier I none 154A-22 none 712-C-96-335 Feb-96 885.4340 Nontarget Insect Testing, Tier I none 154A-23 none 712-C-96-336 Feb-96 885.4380 Honey Bee Testing, Tier I none 154A-24 none 712-C-96-337 Feb-96 885.4600 Avian Chronic Pathogenicity and Reproduction Test, Tier III none 154A-26 none 712-C-96-342 Feb-96 885.4650 Aquatic Invertebrate Range Testing, Tier III none 154A-27 none 712-C-96-343 Feb-96 885.4700 Fish Life Cycle Studies, Tier III none 154A-28 none 712-C-96-344 Feb-96 885.4750 Aquatic Ecosystem Test none 154A-29 none 712-C-96-345 Feb-96 Group E—Environmental Expression Test Guidelines 885.5000 Background for Microbial Pesticides Testing none 155A-1,2 none 712-C-96–056 Feb-96 885.5200 Expression in a Terrestrial Environment none 155A-10 none 712-C-96–338 Feb-96 885.5300 Expression in a Freshwater Environment none 155A-11 none 712-C-96-339 Feb-96 885.5400 Expression in a Marine or Estuarine Environment none 155A-12 none 712-C-96-312 Feb-96 DRAFT 885 Test Guidelines Please note those guidelines labeled as “Public Draft” are not yet available in final form. Although you may consult these guidelines, please check with the appropriate office before you use a draft guideline to generate data for submission to EPA under FIFRA, FFDCA or TSCA. Reserved: We use the phrase “[Reserved]” in the title column as a placeholder whenever the number has been assigned, but the FINAL Guide- line has not yet been issued. a Document incorrectly says publication Number ends in “-304”. b Document incorrectly says publication Number ends in “-318”. c Document incorrectly says publication Number ends in “-232”. Source: CFR 40 Part 158 Subpart V. 169

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