§ 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 | |||||||||||
885.4050 | 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 or TEP | 1, 2, 5 |
885.4240 | Freshwater invertebrate toxicity/pathogenicity | R | R | R | R | CR | CR | CR | CR | TGAI or TEP | 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 |
885.4380 | Honey bee testing | R | R | R | R | R | CR | NR | CR | TGAI | 1 |
Tier II | |||||||||||
885.5200 | Terrestrial environmental expression tests | CR | CR | CR | CR | CR | NR | NR | CR | TGAI or TEP | 9 |
885.5300 | Freshwater environmental expression tests | CR | CR | CR | CR | CR | NR | NR | CR | TGAI or TEP | 10 |
885.5400 | Marine or estuarine environmental expression tests | CR | CR | CR | CR | CR | NR | NR | CR | TGAI or TEP | 11, 12 |
Tier III | |||||||||||
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 | |||||||||||
850.2500 850.1950 | Field testing for terrestrial wildlife and Field testing for aquatic organisms | CR | CR | CR | CR | CR | NR | NR | CR | TGAI or TEP | 11, 16 |
850.2500 | Simulated or actual field tests (birds, mammals) | CR | CR | CR | CR | CR | NR | NR | CR | TEP | 16, 17, 20 |
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 |
850.4300 | Simulated or actual field tests (plants) | CR | CR | CR | CR | CR | NR | NR | CR | TEP | 16, 18, 19, 20 |