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.
| Guideline Number | Data Requirement | Use Patterns | Aquatic | Food/Feed | Nonfood | Terrestrial | Food/Feed/Nonfood | Forestry | Residential | Outdoor | Greenhouse | Food/Nonfood | Indoor | Food/Nonfood | Industrial | Test Substance | Test Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 885.4050 | Avian oraltoxicity | NR | R | R | R | R | NR | NR | NR | TGAI | 1, 2 | ||||||
| 885.4200 | Freshwater fish toxicity/pathogenicity | NR | R | R | R | NR | NR | NR | NR | TGAI | 1, 2, 3 | ||||||
| 885.4240 | Freshwater invertebrate toxicity/pathogenicity | NR | R | R | R | NR | NR | NR | NR | TGAI | 1, 2, 3 | ||||||
| 885.4300 | Nontarget planttesting | NR | NR | NR | R | NR | NR | NR | NR | TEP | 1, 4 | ||||||
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Code of Federal Regulations
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| 885.4340 | Nontarget insect testing | R | R | R | R | NR | NR | NR | NR | TGAI | 1, 5 | ||||||
| 885.4380 | Honey bee testing | R | R | R | R | NR | NR | NR | NR | TGAI | 1 | ||||||
(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.