Microbial pesticides nontarget organisms and environmental fate data requirements table.

§ 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
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