National Academies Press: OpenBook

Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops (2011)

Chapter: Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V

« Previous: Appendix A: Biographic Information on the Committee on Mycoherbicides for Eradicating Illicit Drug Crops
Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×

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
Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
Guideline Number Data Requirement All Use Patterns Test Substance Test Notesa
MP EP
Physical and Chemical Characteristics
830.7100 Viscosity R MP EP 4
830.7300 Density/relative density/bulk density (specific gravity) R TGAI TGAI

Abbreviations: EP, end-use product; MP. manufacturing-use product; R, required; TGAI. technical grade of the active ingredient.

aTest notes. The following test notes are applicable to the data requirements for microbial pesticides product analysis as referenced m 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 product. 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 Number Data Requirement All Use Patterns Test Substance Data to Support MP or EP Test 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. poultry, eggs CR EP 1
885.2600 Magnitude of residues in potable water, fish, and irrigated crops CR EP 1

Abbreviations: CR, conditionally required: EP, end-use product; TGAI, technical grade of the active ingredient.

aTest 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 characterization 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.

Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×

TABLE B-3 Microbial Pesticides Toxicology Data Requirements

Guideline All Use Test Test
Number Data Requirement Patterns Substance Notesc
Tire I
885.3050 Acute oral toxicity/pathogenicity R TGAI 1
885.3150 Acute pulmonary toxicity pathogenicity R TGAI
885.3200 Acute injection toxicity/pathogenicity/Cintravenous) Acute injection toxicity/pathogenicity/(intraperitoneal) R TGAI 2
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
Tire II
885.3550 Acute toxicology CR TGAI 7
885.3600 Subchronic toxicity/pathogenicity CR TGAI 8
Tire 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. teclmical grade of the active ingredient

aTest 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.

Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×

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 toxicity 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 contaminants which are parasitic for mammals.

10. Data may be required for products known to contain or suspected to contain carcinogenic viruses or for microbial components that are identified as having significant toxicity 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 system.

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.

13. Test standards may have to be modified depending on the characteristics of the microorganism. 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.

Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×

TABLE B-4 Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements

Guideline Number Data Requirement Use Patterns Test Substance Test Notesa
Aquatic Terrestrial
Food/Feed Nonfood Food/Feed/Nonfood Forestry Residential Greenhouse Indoor Industrial
Outdoor Food/Nonfood Food/Nonfood
Tier I
885.4050 Avian oral toxicity R R R R R CR CR CR TGAI 1-2
885.4100 Avian inhalation toxicity/pathogenicity CR CR CR CR CR CR CR CR TGAI 1,2,3
885.4150 Wild mammal toxicity/pathogenicity CR CR CR CR CR NR NR CR TGAI 1,4
885.4200 Freshwater fish toxicity, pathogenicity R R R R CR CR CR CR TGAI orTEP 1,2,5
885.4240 Freshwater invertebrate toxicity/pathogenicity R R R R CR CR CR CR TGAI orTEP 1,2,5
885.4280 Estuarine Marine fish testing Estuarine and marine invertebrate testing CR CR CR CR CR NR NR CR TGAI 1,6
885.4300 Nontarget plant testing CR CR CR R CR NR CR CR TEP 1,7
885.4340 Nontarget insect testing R R R R R CR NR CR TGAI 1,8
885.43S0 Honey bee testing R R R R R CR NR CR TGAI 1
Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
Tier II
885.5200 Terrestrial environmental expression tests CR CR CR CR CR NR NR CR TGAI orTEP 9
885.5300 Freshwater environmental expression tests CR CR CR CR CR NR NR CR TGAI orTEP 10
885.5400 Marine or estiiarine environmental expression tests CR CR CR CR CR NR NR CR TGAI orTEP 11,12
TierIII
885.4600 Avian chronic pathogenicity and reproduction test CR CR CR CR CR NR NR CR TGAI 12,13
885.4650 Aquatic invertebrate range testing CR CR CR CR CR NR NR CR TGAI 12,14
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
350.2500 350.1950 Field testing for terrestrial wildlife and Field testing for aquatic organisms CR CR CR CR CR NR NR CR TGAI orTEP 11,16
350.2500 Simulated or actual field tests (birds, mammals) CR CR CR CR CR NR NR CR TEP 16,17, 20
Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
Guideline Number Data Requirement Use Patterns Test Substance Test Notesa
Aquatic Terrestrial
Food/Feed Nonfood Food/Feed/Nonfood Forestry Residential Greenhouse Indoor Industrial
Outdoor Food/Nonfood Food/Nonfood
850.1950 Simulated or actual field test (aquatic organisms) CR CR CR CR CR NR NR CR TEP 16, 18, 19,20
850.2500 Simulated or actual field tests (insect predators, parasites) CR CR CR CR CR NR NR CR TEP 16,18, 19,20
850.3040 Simulated or actual field tests (insect pollinators) CR CR CR CR CR NR NR CR TEP 16,18, 19,20
350.4300 Simulated or actual field tests (plants) CR CR CR CR CR NR NR CR TEP 16, 18, 19,20

Abbreviations: CR, conditionally required; NR, not required; R, required; TEP. typical end-use product; TGAI, technical grade of the active ingredient

aTest notes. The following test notes are applicable to the data requirements for microbial pesticides nontarget organism and environmental fate as referenced m 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 toxicity/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.

Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×

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 TierI 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 TierI 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 TierI 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.

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 pathogenicity or infectivity was observed in TierI aquatic studies.

Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×

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 applications 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.

Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×

TABLE B-5 Series 885—Microbial Pesticide Test Guidelines as of January 2010

OPPTS Guideline Number Guideline Names Other Reference Numbers EPA Pub Number Dare Issued
OPPT OPP OECD
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 153 A-10 none 712-C-96-307 Feb-96
885.2550 Magnitude of Residues in Meat, Milk. Poultry. Eggs none 153 A-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
Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
OPPTS Guideline Number Guideline Names Other Reference Numbers EPA Pub Number Dare Issued
OPPT OPP OECD
Group C-Toxicology Test Guidelines
885.3000 Background-Mammalian Toxicity/Pa tho genie itylnfectivity 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
885.3150 Acute Pulmonary Toxicity/Pathogenicity none 152A-12 none 712-C-96-317b 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 Subclironic 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 Pest Control Agents none 154A-1, 154A-2, 154A-3, 154A-4, 154A-5 none 712-C-96-328 Feb-96
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
Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
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 m 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 m 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 Guideline has not yet been issued.

aDocument incorrectly says publication Number ends in “-304”.

bDocument incorrectly says publication Number ends in “-318”.

cDocument incorrectly says publication Number ends in “-232”.

Source: CFR40 Part 158 Subpart V.

Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×

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Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
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×
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×
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Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
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Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
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Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
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Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
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Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
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Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
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Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
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Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
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Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
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Suggested Citation:"Appendix B: EPA Requirements and Guidelines under 40 CFR 158, Subpart V." National Research Council. 2011. Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops. Washington, DC: The National Academies Press. doi: 10.17226/13278.
×
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The control of illicit-drug trafficking and drug use is a difficult and complex process that involves a variety of prevention, control, treatment, and law enforcement strategies. Eradication strategies for controlling illicit-drug crops are used to target the beginning of the drug-supply chain by preventing or reducing crop yields. Mycoherbicides have been proposed as an eradication tool to supplement the current methods of herbicide spraying, mechanical removal, and manual destruction of illicit-drug crops. Some people regard them as preferable to chemical herbicides for controlling illicit-drug crops because of their purported specificity to only one plant species or a few closely related species. As living microorganisms, they have the potential to provide long-term control if they can persist in the environment and affect later plantings. Research on mycoherbicides against illicit-drug crops has focused on three pathogens: Fusarium oxysporum f.sp. cannabis for cannabis (Cannabis sativa), F. oxysporum f.sp. erythroxyli for coca (Erythroxylum coca and E. novogranatense), and Crivellia papaveracea or Brachycladium papaveris (formerly known as Pleospora papaveracea and Dendryphion penicillatum, respectively) for opium poppy (Papaver somniferum).

Feasibility of Using Mycoherbicides for Controlling Illicit Drug Crops addresses issues about the potential use of the proposed mycoherbicides: their effectiveness in eradicating their target plants; the feasibility of their large-scale industrial manufacture and delivery; their potential spread and persistence in the environment; their pathogenicity and toxicity to nontarget organisms, including other plants, fungi, animals, and humans; their potential for mutation and resulting effects on target plants and nontarget organisms; and research and development needs.

On the basis of its review, the report concludes that the available data are insufficient to determine the effectiveness of the specific fungi proposed as mycoherbicides to combat illicit-drug crops or to determine their potential effects on nontarget plants, microorganisms, animals, humans, or the environment. However, the committee offers an assessment of what can and cannot be determined at the present time regarding each of the issues raised in the statement of task.

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