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Electronic Code of Federal Regulations

e-CFR Data is current as of April 15, 2014

Title 40: Protection of Environment
PART 158—DATA REQUIREMENTS FOR PESTICIDES


Subpart V—Microbial Pesticides


Contents
§158.2100   Microbial pesticides definition and applicability.
§158.2110   Microbial pesticides data requirements.
§158.2120   Microbial pesticides product analysis data requirements table.
§158.2130   Microbial pesticides residue data requirements table.
§158.2140   Microbial pesticides toxicology data requirements table.
§158.2150   Microbial pesticides nontarget organisms and environmental fate data requirements table.
§158.2160   Microbial pesticides product performance data requirements.
§158.2170   Experimental use permit data requirements—microbial pesticides.
§158.2171   Experimental use permit microbial pesticides product analysis data requirements table.
§158.2172   Experimental use permit microbial pesticides residue data requirements table.
§158.2173   Experimental use permit microbial pesticides toxicology data requirements table.
§158.2174   Experimental use permit microbial pesticides nontarget organisms and environmental fate data requirements table.

Source: 72 FR 61002, Oct. 26, 2007, unless otherwise noted.

§158.2100   Microbial pesticides definition and applicability.

(a) This subpart applies to all living or dead microbial pesticides as described in paragraphs (b) and (c) of this section.

(b) Definition. Microbial pesticide is a microbial agent intended for preventing, destroying, repelling, or mitigating any pest, or intended for use as a plant regulator, defoliant, or desiccant, that:

(1) Is a eucaryotic microorganism including, but not limited to, protozoa, algae, and fungi;

(2) Is a procaryotic microorganism, including, but not limited to, Eubacteria and Archaebacteria; or

(3) Is a parasitically replicating microscopic element, including, but not limited to, viruses.

(c) Applicability. (1) This subpart applies to microbial pesticides as specified in paragraphs (c)(2), (c)(3), and (c)(4) of this section.

(2) Each new isolate of a microbial pesticide is a new active ingredient and must be registered independently of any similarly designated and already registered microbial pesticide active ingredient. Each new isolate for which registration is sought must have a unique identifier following the taxonomic name of the microorganism, and the registration application must be supported by data required in this subpart. This does not preclude the possibility of using data from another isolate, provided sufficient similarity is established, to support registration.

(3) Genetically modified microbial pesticides may be subject to additional data or information requirements on a case-by-case basis depending on the particular microbial agent and/or its parental strains, the proposed pesticide use pattern, and the manner and extent to which the organism has been genetically modified.

(4) Pest control organisms such as insect predators, nematodes, and macroscopic parasites are exempt from the requirements of FIFRA as authorized by section 25(b) of FIFRA and specified in §152.20 (a) of this chapter.

[72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52612, Aug. 30, 2012]

§158.2110   Microbial pesticides data requirements.

(a) For all microbial pesticides. (1) The following §158.2120 through §158.2150 identify the data requirements that are required to support registration of microbial pesticides. The variations in the test conditions are identified within the test notes.

(2) Each data table includes “use patterns” under which the individual data are required, with variations including all use patterns, food and nonfood uses for terrestrial and aquatic applications, greenhouse, indoor, forestry, and residential outdoor applications under certain circumstances.

(3) The categories for each data requirement are “R,” which stands for required, and “CR” which stands for conditionally required. If a bracket appears around the “R” or “CR,” the data are required for both the registration and experimental use permit requests. Generally, “R” indicates that the data are more likely required than for those data requirements with “CR.” However, in each case, the regulatory text preceding the data table and the test notes following the data table must be used to determine whether the data requirement must be satisfied.

(4) Each table identifies the test substance that is required to be tested to satisfy the data requirement. Test substances may include: technical grade active ingredient (TGAI), manufacturing-use product (MP), end-use product (EP), typical end-use product (TEP), residue of concern, and pure active ingredient (PAI) or all of the above (All). Commas between the test substances (i.e., TGAI, EP) indicate that data may be required on the TGAI or EP or both depending on the conditions set forth in the test note. Data requirements which list two test substances (i.e., TGAI and EP) indicate that both are required to be tested. Data requirements that list only MP as the test substance apply to products containing solely the technical grade of the active ingredient and manufacturing-use products to which other ingredients have been intentionally added. Data requirements listing the EP as the test substance apply to any EP with an ingredient in the end-use formulation other than the active ingredient that is expected to enhance the toxicity of the product.

(b) Additional data requirements for genetically modified microbial pesticides. Additional requirements for genetically modified microbial pesticides may include but are not limited to: genetic engineering techniques used; the identity of the inserted or deleted gene segment (base sequence data or enzyme restriction map of the gene); information on the control region of the gene in question; a description of the “new” traits or characteristics that are intended to be expressed; tests to evaluate genetic stability and exchange; and selected Tier II environmental expression and toxicology tests.

§158.2120   Microbial pesticides product analysis data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product analysis data requirements and the substance to be tested for a particular microbial pesticide. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are identified in paragraph (d) of this section.

(b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above.

(c) Table. The table in this paragraph shows the data requirements for microbial pesticides product analysis. The test notes are shown in paragraph (d) of this section.

Table—Microbial Pesticides Product Analysis Data Requirements

Test guideline No.Data requirementAll use
patterns
Test substanceTest notes
MPEP
Product Chemistry and Composition
885.1100Product identityRMPEP
885.1200Manufacturing processRTGAI and MPTGAI and EP
885.1250Deposition of a sample in a nationally recognized culture collectionRTGAITGAI1
885.1300Discussion of formation of unintentional ingredientsRTGAI and MPTGAI and EP
Analysis and Certified Limits
885.1400Analysis of samplesRTGAI and MPTGAI and EP2
885.1500Certification of limitsRMPEP
Physical and Chemical Characteristics
830.6302ColorRTGAITGAI
830.6303Physical stateRTGAITGAI
830.6304OdorRTGAITGAI
830.6313Stability to normal and elevated temperatures, metals, and metal ionsRTGAITGAI
830.6317Storage stabilityRTGAI and MPTGAI and EP
830.6319MiscibilityRMPEP3
830.6320Corrosion characteristicsRMPEP4
830.7000pHRTGAITGAI
830.7100ViscosityRMPEP5
830.7300Density/relative density/bulk density (specific gravity)RTGAITGAI

(d) 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 for each isolate of a microbial pesticide. Isolates must be deposited with an agreement to ensure that the sample will be maintained and will not be discarded for the duration of the associated registration(s).

2. 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.

3. Only required for emulsifiable liquid forms of microbial pesticides.

4. Required when microbial pesticides are packaged in metal, plastic, or paper containers.

5. Only required for liquid forms of microbial pesticides.

[72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52612, Aug. 30, 2012]

§158.2130   Microbial pesticides residue data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the residue chemistry data requirements and the substance to be tested for a particular microbial pesticide. Specific conditions, qualifications, or exceptions to the designated test appear in paragraph (d) of this section, and the procedures appear in paragraph (e) of this section.

(b) Key. R=required; CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use product; TGAI=Technical grade of the active ingredient; All=All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table:

(c) Table. The following table shows the data requirements for microbial pesticides residue. The test notes are shown in paragraph (d) of this section.

Table—Microbial Pesticides Residue Data Requirements

Guideline Number Data Requirement All Use Patterns Test Substance Data to Support MP or EP Test Notes
885.2100Chemical IdentityCREP1
885.2200Nature of the Residue in plantsCREP1
885.2250Nature of the Residue in animalsCREP1
885.2300Analytical methods - plantsCRTGAI1
885.2350Analytical methods - animalsCRTGAI1
885.2400Storage StabilityCREP1
885.2500Magnitude of residue in plantsCREP1
885.2550Magnitude of residues in meat, milk, poultry, eggsCREP1
885.2600Magnitude of residues in potable water, fish, and irrigated cropsCREP1

(d) 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 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.

§158.2140   Microbial pesticides toxicology data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the toxicology data requirements for a particular pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (d) of this section.

(b) Key. R=Required; CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use product; TGAI=Technical grade of the active ingredient; All=All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table:

(c) Table. The following table shows the data requirements for microbial pesticides toxicology. The test notes are shown in paragraph (d) of this section.

Table—Microbial Pesticides Toxicology Data Requirements

Guideline Number Data Requirement All Use Patterns Test Substance Test Notes
Tier I
885.3050Acute oral toxicity/pathogenicityRTGAI1
885.3150Acute pulmonary toxicity/pathogenicityRTGAI--
885.3200Acute injection toxicity/pathogenicity/(intravenous)
Acute injection toxicity/pathogenicity/(intraperitoneal)
RTGAI2
885.3400Hypersensitivity incidentsRAll3
885.3500Cell cultureRTGAI4
870.1100Acute oral toxicityRMP , EP1, 5
870.1200Acute dermal toxicityRMP , EP5
870.1300Acute inhalation toxicityRMP , EP5, 6
870.2400Acute eye irritationRMP , EP5
870.2500Primary dermal irritationRMP , EP5
Tier II
885.3550Acute toxicologyCRTGAI7
885.3600Subchronic toxicity/pathogenicityCRTGAI8
Tier III
885.3650Reproductive fertility effectsCRTGAI9, 13
870.4200CarcinogenicityCRTGAI10, 13
870.7800ImmunotoxicityCRTGAI11, 13
885.3000Infectivity/pathogenicity analysisCRTGAI12, 13

(d) 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.

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 non-pathogenic 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.

§158.2150   Microbial pesticides nontarget organisms and environmental fate data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms data requirements for a particular microbial pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.

(b) Use patterns. Aquatic uses include: food and feed, nonfood uses (e.g., outdoor, residential, and industrial). Terrestrial uses include: Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food and food), Indoor (food and nonfood), and Industrial.

(c) Key. R=Required; CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use product; TGAI=Technical grade of the active ingredient; All=All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:

(d) Table. The following table shows the data requirements for microbial pesticides nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section.

Table—Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements

Guideline Number Data Requirement Use Patterns Test Substance Test Notes
Aquatic Terrestrial
Food/Feed Nonfood Food/Feed/Nonfood Forestry Residential Greenhouse Indoor Industrial
Outdoor Food/Nonfood Food/Nonfood
Tier I
885.4050Avian oral toxicityRRRRRCRCRCRTGAI1, 2
885.4100Avian inhalation toxicity/pathogenicityCRCRCRCRCRCRCRCRTGAI1, 2, 3
885.4150Wild mammal toxicity/pathogenicityCRCRCRCRCRNRNRCRTGAI1, 4
885.4200Freshwater fish toxicity/ pathogenicityRRRRCRCRCRCRTGAI or TEP1, 2, 5
885.4240Freshwater invertebrate toxicity/pathogenicityRRRRCRCRCRCRTGAI or TEP1, 2, 5
885.4280Estuarine/Marine fish testing
Estuarine and marine invertebrate testing
CRCRCRCRCRNRNRCRTGAI1, 6
885.4300Nontarget plant
testing
CRCRCRRCRNRCRCRTEP1, 7
885.4340Nontarget insect testingRRRRRCRNRCRTGAI1, 8
885.4380Honey bee testingRRRRRCRNRCRTGAI1
Tier II
885.5200Terrestrial environmental expression testsCRCRCRCRCRNRNRCRTGAI or TEP9
885.5300Freshwater environmental expression testsCRCRCRCRCRNRNRCRTGAI or TEP10
885.5400Marine or estuarine environmental expression testsCRCRCRCRCRNRNRCRTGAI or TEP11, 12
Tier III
885.4600Avian chronic pathogenicity and reproduction testCRCRCRCRCRNRNRCRTGAI12, 13
885.4650Aquatic invertebrate range testingCRCRCRCRCRNRNRCRTGAI12, 14
885.4700Fish life cycle studiesCRCRCRCRCRNRNRCRTGAI12, 14
885.4750Aquatic ecosystem testCRCRCRCRCRNRNRCRTGAI15
Tier IV
850.2500
850.1950
Field testing for terrestrial wildlife and Field testing for aquatic organismsCRCRCRCRCRNRNRCRTGAI or TEP11, 16
850.2500Simulated or actual field tests (birds, mammals)CRCRCRCRCRNRNRCRTEP16, 17, 20
850.1950Simulated or actual field test (aquatic organisms)CRCRCRCRCRNRNRCRTEP16, 18, 19, 20
850.2500Simulated or actual field tests (insect predators, parasites)CRCRCRCRCRNRNRCRTEP16, 18, 19, 20
850.3040Simulated or actual field tests (insect pollinators)CRCRCRCRCRNRNRCRTEP16, 18, 19, 20
850.4300Simulated or actual field tests (plants)CRCRCRCRCRNRNRCRTEP16, 18, 19, 20

(e) 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 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.

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 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 Tier I aquatic studies.

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.

§158.2160   Microbial pesticides product performance data requirements.

Product performance data must be developed for all microbial pesticides. However, the Agency has waived all requirements to submit efficacy data unless the pesticide product bears a claim to control public health pests, such as pest microorganisms infectious to man in any area of the inanimate environment or a claim to control vertebrates (including but not limited to: rodents, birds, bats, canids, and skunks) or invertebrates (including but not limited to: mosquitoes and ticks) that may directly or indirectly transmit diseases to humans. However, each registrant must ensure through testing that his products are efficacious when used in accordance with label directions and commonly accepted pest control practices. The Agency reserves the right to require, on a case-by-case basis, submission of efficacy data for any pesticide product registered or proposed for registration.

§158.2170   Experimental use permit data requirements—microbial pesticides.

(a) For all microbial pesticides. (1) The following §158.2171 through §158.2174 identify the data requirements that are required to support experimental use permits for microbial pesticides. The variations in the test conditions are identified within the test notes.

(2) For general information on the data requirement tables, see §158.2110(a)(2)-(4).

(b) Additional data requirements for genetically modified microbial pesticides. Additional requirements for genetically modified microbial pesticides may include but are not limited to: genetic engineering techniques used; the identity of the inserted or deleted gene segment (base sequence data or enzyme restriction map of the gene); information on the control region of the gene in question; a description of the “new” traits or characteristics that are intended to be expressed; tests to evaluate genetic stability and exchange; and selected Tier II environmental expression and toxicology tests.

§158.2171   Experimental use permit microbial pesticides product analysis data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product analysis data requirements and the substance to be tested for a particular microbial pesticide. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are identified in paragraph (d) of this section.

(b) Key. R = Required; CR = Conditionally required; NR = Not required; MP = Manufacturing-use product; EP = End-use product; TEP = Typical end-use product; TGAI = Technical grade of the active ingredient; All = All of the above.

(c) Table. The table in this paragraph shows the data requirements for experimental use permit microbial pesticides product analysis. The test notes are shown in paragraph (d) of this section.

Table—EUP Microbial Pesticides Product Analysis Data Requirements

Test guideline No.Data requirementAll use patternsTest substanceTest notes
MPEP
Product Chemistry and Composition
885.1100Product identityRMPEP
885.1200Manufacturing processRTGAI and MPTGAI and EP1, 2
885.1250Deposition of a sample in a nationally recognized culture collectionRTGAITGAI3
885.1300Discussion of formation of unintentional ingredientsRTGAI and MPTGAI and EP2
Analysis and Certified Limits
885.1400Analysis of samplesRTGAI and MPTGAI and EP2, 4
885.1500Certification of limitsRMPEP
Physical and Chemical Characteristics
830.6302ColorRTGAITGAI
830.6303Physical stateRTGAITGAI
830.6304OdorRTGAITGAI
830.6313Stability to normal and elevated temperatures, metals, and metal ionsRTGAITGAI
830.6317Storage stabilityRTGAI and MPTGAI and EP
830.6319MiscibilityRMPEP5
830.6320Corrosion characteristicsRMPEP6
830.7000pHRTGAITGAI
830.7100ViscosityRMPEP7
830.7300Density/relative density/bulk density (specific gravity)RTGAITGAI

(d) Test notes. The following test notes are applicable to the data requirements for experimental use permit microbial pesticides product analysis as referenced in the last column of the table contained in paragraph (c) of this section.

1. If an experimental use permit is being sought, and if the pesticide is not already under full-scale production, a schematic diagram and/or description of the manufacturing process suffices.

2. If an experimental use permit is being sought, and if the product is not already under full-scale production, a discussion of unintentional ingredients is required to be submitted to the extent this information is available.

3. Required for each isolate of a microbial pesticide. Isolates must be deposited with an agreement to ensure that the sample will be maintained and will not be discarded for the duration of the associated experimental use permit(s).

4. 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 pesticides in the production stage, a preliminary product analytical method and data would suffice to support an experimental use permit. For full registration, generally an analysis of samples is a compilation of batches, over a period of time, depending on the frequency of manufacturing.

5. Only required for emulsifiable liquid forms of microbial pesticides.

6. Required when microbial pesticides are packaged in metal, plastic, or paper containers.

7. Only required for liquid forms of microbial pesticides.

[72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52613, Aug. 30, 2012]

§158.2172   Experimental use permit microbial pesticides residue data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the residue chemistry data requirements and the substance to be tested for a particular microbial pesticide. Specific conditions, qualifications, or exceptions to the designated test appear in (d) of this section, and the procedures appear in paragraph (e) of this section.

(b) Key. R=Required; CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use product; TGAI=Technical grade of the active ingredient; All=All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table:

(c) Table. The following table shows the data requirements for experimental use permit microbial pesticides residue. The test notes are shown in paragraph (d) of this section.

Table—EUP Microbial Pesticides Residue Data Requirements

Guideline Number Data Requirement All Use Patterns Test Substance Data to Support MP or EP Test Notes
885.2100Chemical IdentityCREP1
885.2200Nature of the Residue in plantsCREP1
885.2250Nature of the Residue in animalsCREP1
885.2300Analytical methods - plantsCRTGAI1
885.2350Analytical methods-animalsCRTGAI1
885.2400Storage StabilityCREP1
885.2500Magnitude of residue in plantsCREP1
885.2550Magnitude of residues in meat, milk, poultry, eggsCREP1
885.2600Magnitude of residues in potable water, fish, and irrigated cropsCREP1

(d) Test notes. The following test note is applicable to the data requirements for experimental use permit 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.

§158.2173   Experimental use permit microbial pesticides toxicology data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the toxicology data requirements for a particular microbial pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (d) of this section.

(b) Key. R=Required; CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use product; TGAI=Technical grade of the active ingredient; All=All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (d) of this section, and apply to the individual tests in the following table:

(c) Table. The following table shows the data requirements for microbial pesticide toxicology. The test notes are shown in paragraph (d) of this section.

Table—EUP Microbial Pesticides Toxicology Data Requirements

Guideline Number Data Requirement All Use Patterns Test Substance Test Notes
885.3050Acute oral toxicity/pathogenicityRTGAI1
885.3150Acute pulmonary toxicity/pathogenicityRTGAI--
885.3200Acute injection toxicity/pathogenicity/(intravenous)
Acute injection toxicity/pathogenicity/(intraperitoneal)
RTGAI2
885.3400Hypersensitivity incidentsRAll3
885.3500Cell cultureRTGAI4
870.1100Acute oral toxicityRMP, EP1, 5
870.1200Acute dermal toxicityRMP, EP5
870.1300Acute inhalation toxicityRMP, EP5, 6
870.2400Acute eye irritationRMP, EP5
870.2500Primary dermal irritationCRMP, EP5

(d) Test notes. The following test notes are applicable to the data requirements for experimental use permit 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.

6. Required when the product consists of, or under conditions of use that would result in an inhalable material (e.g., gas, volatile substances, or aerosol particulate).

§158.2174   Experimental use permit microbial pesticides nontarget organisms and environmental fate data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms data requirements for a particular microbial pesticide product. Notes that apply to an individual test including specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.

(b) Use patterns. Aquatic uses include: food and feed, nonfood uses (e.g., outdoor, residential, and industrial). Terrestrial uses include: Food, Feed, Non-Food, Forestry, Residential outdoor, greenhouse (food and food), Indoor (food and nonfood), and Industrial.

(c) Key. R=Required; CR=Conditionally required; NR=Not required; MP=Manufacturing-use product; EP=End-use product; TEP=Typical end-use product; TGAI=Technical grade of the active ingredient; All=All of the above. Specific conditions, qualifications, or exceptions to the designated test procedures appear in paragraph (e) of this section, and apply to the individual tests in the following table:

(d) Table. The following table shows the data requirements for experimental use permit microbial pesticides nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section.

Table—EUP Microbial Pesticides Nontarget Organisms and Environmental Fate Data Requirements

Guideline Number Data Requirement Use Patterns Test Substance Test Notes
Aquatic Terrestrial
Food/Feed Nonfood Food/Feed/Nonfood Forestry Residential Greenhouse Indoor Industrial
Outdoor Food/Nonfood Food/Nonfood
885.4050Avian oral
toxicity
NRRRRRNRNRNRTGAI1, 2
885.4200Freshwater fish toxicity/pathogenicityNRRRRNRNRNRNRTGAI1, 2, 3
885.4240Freshwater invertebrate toxicity/pathogenicityNRRRRNRNRNRNRTGAI1, 2, 3
885.4300Nontarget plant
testing
NRNRNRRNRNRNRNRTEP1, 4
885.4340Nontarget insect testingRRRRNRNRNRNRTGAI1, 5
885.4380Honey bee testingRRRRNRNRNRNRTGAI1

(e) 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. Tests to support EUP's are based on the application timing and acreage.

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 a passerine species if there is a concern. The coldwater fish is preferred for freshwater fish testing. However, two species (coldwater and warmwater fish are the preferred species) must be tested for uses involving direct freshwater exposure. Freshwater invertebrates are preferred for invertebrate testing.

3. Required when there will be significant exposure to aquatic organisms (fish and invertebrates).

4. Required if the microbial pesticide is taxonomically related to a known plant pathogen.

5. 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.



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