40 CFR 158.2060 - Biochemical pesticides nontarget organisms and environmental fate data requirements table.

§ 158.2060 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, one acute freshwater invertebrate study, plant toxicity testing, and a honeybee acute contact 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 biochemical pesticides nontarget organisms and environmental fate. The test notes are shown in paragraph (e) of this section.
Table—Biochemical Pesticides Nontarget Organisms and Environmental Fate Data Requirements
Guideline Number Data Requirement Use Patterns Test Substance Test Notes
Terrestrial Aquatic Greenhouse Forestry, Residential Outdoor Indoor
Food/Feed/Nonfood Food/Nonfood Food/Nonfood Food/Nonfood
Tier I
Avian Testing
850.2100 Avian acute oral toxicity R R CR R CR TGAI, EP 1, 2, 3, 4
850.2200 Avian dietary toxicity R R CR R CR TGAI, EP 1, 2, 3, 4
Aquatic Organism Testing
850.1075 Fish acute toxicity, freshwater R R CR R CR TGAI, EP 2, 3, 4, 5
850.1010 Aquatic invertebrate acute toxicity, freshwater R R CR R CR TGAI, EP 2, 3, 5
Nontarget Plant Testing
850.4100 Terrestrial Plant Toxicity, Seedling emergence R R NR R NR TGAI, EP 5
850.4150 Terrestrial Plant Toxicity, Vegetative vigor R R NR R NR TGAI, EP 5
Insect Testing
880.4350 Nontarget Insect Testing R R R R NR TGAI 14
Tier II
Environmental Fate Testing
163-1 (835.1230) Sediment and soil adsorption/desorption for parent and degradates CR CR CR CR NR TGAI 6
163-1 (835.1240) Soil column leaching CR CR CR CR NR TGAI 6
163-2 (835.1410) Laboratory volatilization from soil CR NR CR CR NR TEP 7
161-1 (835.2120) Hydrolysis CR CR CR CR NR TGAI 6
161-1 (835.4100) Aerobic soil metabolism CR NR CR CR NR TGAI 6
161-2 (835.2240) Photodegradation in water CR CR CR CR NR TGAI 6
161-3 (835.2410) Photodegradation on soil CR NR CR CR NR TGAI 6
162-2 (835.4200) Anaerobic soil metabolism CR NR NR NR NR TGAI 6
162-4 (835.4300) Aerobic aquatic metabolism CR CR CR CR NR TGAI 6
162-3 (835.4400) Anaerobic aquatic metabolism CR CR NR NR NR TGAI 6
880.4425 Dispenser - water leaching CR NR CR CR NR EP 8
Nontarget Plant
850.4225 Seedling emergence R R NR R NR TGAI 9
850.4250 Vegetative vigor R R NR R NR TGAI 9
Tier III
Aquatic Fauna Chronic, Life Cycle, and Field Studies
850.1300850.1400 850.1500 Freshwater fish/invertebrate testing CR CR NR CR NR TGAI 10
850.1025850.1035 850.1045 850.1055 850.1350 850.1400 850.1500 Marine/Estuarine fish/invertebrate animal testing CR CR NR CR NR TGAI 10
850.1950 Aquatic field fish/invertebrate testing CR CR NR CR NR EP 10
Terrestrial Wildlife
850.2300 Avian Reproduction CR CR NR CR NR TGAI 11
850.2400 Wild mammal acute toxicity CR CR NR CR NR TGAI 11
850.2500 Terrestrial field testing CR CR NR CR NR EP 11
Beneficial Insects
850.3040 Field testing for Pollinators CR CR NR CR NR TEP 12
Nontarget Plants
850.4225850.4250 850.4300 850.4450 Nontarget plant CR CR NR CR NR TGAI 13
(e) Test notes. The following test notes are applicable to the data requirements for 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. Tests for pesticides intended solely for indoor application would be required on a case-by-case basis, depending on use pattern, physical/chemical properties, production volume, and other pertinent factors.
3. Not required for any use groups if the pesticide is highly volatile (estimated volatility >5 ×10−5atm m3/mol).
4. Preferred test species are Upland game, waterfowl, or passerine for avian acute oral toxicity studies; Upland game and waterfowl for avian dietary studies; and coldwater fish species for acute freshwater fish studies.
5. Required for the EP when the end-use formulation may contain other ingredients that may be toxic to nontarget organisms.
6. Required on a case-by-case basis when results from Tier I studies indicate adverse effects.
7. Required when results of any one or more of the nontarget organism studies in Tier I indicate potential adverse effects on nontarget organisms and the pesticide is to be applied on land. In view of methdological difficulties with the study of photodegradation in air, prior consultation with the Agency regarding the protocol is recommended before the test is performed.
8. Required when results of any one or more of the nontarget organism studies in Tier I indicate potential adverse effects on nontarget organisms and the pesticide is to be applied in a passive dispenser.
9. Required to support registration of known phytotoxicants, i.e., herbicides, desiccants, defoliants, and plant growth regulators.
10. Required if environmental fate characteristics indicate that the estimated environmental concentration of the pesticide in the aquatic environment is >0.01 of any EC50or LC50 determined in the aquatic nontarget organism testing.
11. Required if either of the following criteria are met:
i. Environmental fate characteristics indicate that the estimated concentration of the pesticide in the terrestrial environment is >0.20 the avian dietary LC50 or equal to >0.20 the avian oral single dose LD50 (converted to ppm).
ii. The pesticide or any of its metabolites or degradation products are stable in the environment to the extent that potentially toxic amounts may persist in the avian or mammalian feed.
12. Required when results of Tier I nontarget organism studies indicate potential adverse effects on nontarget insects and results of Tier II tests indicate exposure of nontarget insects. Additional insect species may have to be tested if necessary to address issues raised by use patterns and potential exposure of important nontarget insect species, (e.g., threatened or endangered species).
13. Required if the product is expected to be transported from the site of application by air, soil, or water. The extent of movement would be determined by the results of the Tier II environmental fate studies.
14. Required depending on pesticide mode of action, method and timing of application, and results of any available efficacy data. Typically the honeybee acute toxicity guideline (guideline 850.3020) satisfies this requirement, however, additional nontarget insect species may have to be tested if necessary to address issues raised by use patterns and potential exposure of important nontarget insect species, (e.g., endangered species.)

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U.S. Code: Title 7 - AGRICULTURE
U.S. Code: Title 21 - FOOD AND DRUGS