158.2084—Experimental use permit biochemical pesticides nontarget organisms and environmental fate data requirements table.
(a) General.
(1)
Sections 158.100 through 158.130 describe how to use this table to determine the terrestrial and aquatic nontarget organisms and fate data requirements for a particular biochemical 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. In general, for all outdoor end-use products including turf, the following studies are required: one avian acute oral, one avian dietary, one acute freshwater fish, and one acute freshwater invertebrate study.
(2)
The data in this section are not required for arthropod pheromones when applied at up to a maximum use rate of 150 grams active ingredient/acre/year except when the product is expected to be available to avian species (i.e., granular formulation).
(b) Use patterns.
The terrestrial use pattern includes products classified under the general use patterns of terrestrial food crop, terrestrial feed crop, and terrestrial nonfood/nonfeed crop. The greenhouse use pattern includes products classified under the general use patterns of greenhouse food crop and greenhouse nonfood crop. The indoor use pattern includes products classified under the general use patterns of indoor food and nonfood use. The remaining terrestrial uses include forestry and residential outdoor use. Data are also required for the general use patterns of aquatic food and nonfood crop use.
(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; Residue of concern=the active ingredient and its metabolites, degradates, and impurities of toxicological concern; 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 biochemical pesticides nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section.
| Guideline Number | Data Requirement | Use Patterns | Terrestrial | Food/Feed/Nonfood | Aquatic | Food/Nonfood | Greenhouse | Food/Nonfood | Forestry, Residential Outdoor | Indoor | Food/Nonfood | Test Substance | Test Notes |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Tier I | |||||||||||||
| Avian Testing | |||||||||||||
| 850.2100 | Avian acute oral toxicity | R | R | NR | R | NR | TGAI, EP | 1, 2, 3 | |||||
| 850.2200 | Avian dietary toxicity | R | R | NR | R | NR | TGAI, EP | 1, 2, 3 | |||||
| Aquatic Organism Testing | |||||||||||||
| 850.1075 | Fish acute toxicity, freshwater | R | R | NR | R | NR | TGAI, EP | 2, 3, 4 | |||||
| 850.1010 | Aquatic invertebrate acute toxicity, freshwater | R | R | NR | R | NR | TGAI, EP | 2, 4 | |||||
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Code of Federal Regulations
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(e) Test notes.
The following test notes are applicable to the data requirements for experimental use permit biochemical pesticides nontarget organisms and environmental fate as referenced in the last column of the table contained in paragraph (d) of this section.
1. Required for the EP when any end-use formulation may contain other ingredients that may be toxic to nontarget organisms or to support arthropod pheromones that would be available to avian wildlife, (e.g., a granular product).
2. Not required for any use groups if the pesticide is highly volatile (estimated volatility >5 X 10-5atm m3/mol).
3. Preferred test species are: upland game, waterfowl, or passerine for avian acute oral toxicity studies; upland game or waterfowl for avian dietary studies; and coldwater fish for acute freshwater fish studies.
4. Required for the EP when the end-use formulation may contain other ingredients that may be toxic to nontarget organisms.