158.2082—Experimental use permit biochemical pesticides residue data requirements table.
(a) General.
Sections 158.100 through 158.130 describe how to use this table to determine the biochemical pesticides residue data requirements for a particular pesticide product and the substance that needs to be tested. These data requirements apply to all biochemical pesticides, i.e., naturally occurring insect repellents and attractants, semiochemicals (e.g., insect pheromones), natural and plant growth regulators. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of this section.
(b) Use patterns.
(1)
Data are required or conditionally required for all pesticides used in or on food and for residential outdoor uses where food crops are grown. Food use patterns include products classified under the general use patterns of terrestrial food crop use, terrestrial feed crop use, aquatic food crop use, greenhouse food crop use, and indoor food use. Data are also conditionally required for aquatic nonfood use if there is direct application to water that could subsequently result in exposure to food.
(2)
Data are conditionally required for nonfood uses if pesticide residues may occur in food or feed as a result of the use. Data requirements for these nonfood uses would be determined on a case-by-case basis. For example, most products used in or near kitchens require residue data for risk assessment purposes even though tolerances may not be necessary in all cases.
(c) Key.
R=Required; CR=Conditionally required; NR=Not required; MP=Manufacturing end-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) Data table.
The following table shows the data requirements for biochemical pesticides residue. The test notes are shown in paragraph (e) of this section.
| Guideline Number | Data Requirement | Use Patterns | Terrestrial | Food/Feed | Aquatic | Food | Greenhouse Food | Indoor Food | Test Substance | Test Notes |
|---|---|---|---|---|---|---|---|---|---|---|
| Supporting Information | ||||||||||
| 860.1100 | Chemical identity | CR | CR | CR | CR | TGAI | 1, 2, 4 | |||
| 860.1200 | Directions for use | CR | CR | CR | CR | -- | 1, 3, 4 | |||
| Nature of Residue | ||||||||||
| 860.1300 | Nature of the residue in plants | CR | CR | CR | CR | TGAI | 1, 4, 5, 6 | |||
| 860.1300 | Nature of the residue in livestock | CR | CR | CR | CR | TGAI or plant metabolite | 1, 7, 8, 9, 13 | |||
| Magnitude of the Residue | ||||||||||
| 860.1400 | Potable water | NR | CR | NR | NR | TGAI | 1, 11 | |||
| 860.1400 | Fish | NR | CR | NR | NR | TGAI | 1, 12 | |||
| 860.1400 | Irrigated crops | NR | CR | NR | NR | TGAI | 1, 13 | |||
| 860.1460 | Food handling | NR | NR | NR | CR | TGAI | 1, 14 | |||
| 860.1480 | Meat/milk/poultry/eggs | CR | CR | CR | CR | TGAI or plant metabolites | 1, 7, 8, 9 | |||
| 860.1500 | Crop field trials | CR | CR | CR | CR | TEP | 1, 3, 4 | |||
| 860.1520 | Processed food/feed | CR | CR | CR | CR | TEP | 1, 15 | |||
| 860.1540 | Anticipated residues | CR | CR | CR | CR | Residue of concern | 1, 9, 16 | |||
| 860.1550 | Proposed tolerances | CR | CR | CR | CR | -- | 1, 17 | |||
| 860.1560 | Reasonable grounds in support of the petition | CR | CR | CR | CR | -- | 1, 9 | |||
| 860.1650 | Submittal of analytical reference standards | CR | CR | CR | CR | TGAI and residue of concern | 9, 18 |
(e) Test notes.
The following test notes are applicable to the data requirements for biochemical pesticides product chemistry and are referenced referenced in the last column of the table contained in paragraph (d) of this section.
1. Residue chemistry data requirements apply to biochemical pesticide products when Tier II or Tier III toxicology data are required, as specified for biochemical agents in the biochemical human health assessment data requirements, § 158.2050.
2. The same chemical identity data are required for biochemical product chemistry data requirements,§ 158.2030 with an emphasis on impurities.
3. Required information includes crops to be treated, rate of application, number and timing of applications, preharvest intervals, and relevant restrictions.
4. Required for residential outdoor uses on food crops if the corresponding agricultural use is not approved or the residential use is expected to produce higher residues based on the label directions.
5. Required unless it is an arthropod pheromone applied at a rate less than or equal to 150 grams active ingredient per acre.
6. Required for indoor uses where the pesticide is applied directly to food, in order to determine metabolites and/or degradates. Not required when only indirect contact with food would occur (e.g., crack and crevice treatments).
7. Required when a pesticide is to be applied directly to livestock, to livestock premises, to livestock drinking water, or to crops used for livestock feed. If results from the plant metabolism study show differing metabolites in plants form those found in animals, an additional livestock metabolism study involving dosing with the plant metabolite(s) may also be required.
8. Livestock feeding studies are required whenever a pesticide residue is present in livestock feed or when direct application to livestock uses occurs.
9. Required if indoor use could result in pesticide residues in or on food or feed.
10. Data are required to determine whether FDA/USDA multiresidue methodology would detect and identify the pesticides and any metabolites.
11. Data are required whenever a pesticide may be applied directly to water, unless it can be demonstrated that the treated water would not be available for human or livestock consumption.
12. Data on fish are required for all pesticides applied directly to water inhabited, or which will be inhabited, by fish that may be caught or harvested for human consumption.
13. Data are required when a pesticide is to be applied directly to water that could be used for irrigation or to irrigation facilities such as irrigation ditches.
14. Data are required whenever a pesticide may be used in food/feed handling establishments.
15. Data on the nature and level of residue in processed food/feed are required when detectible residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance higher than that of the raw agricultural commodity.
16 Anticipated residue data are required when the assumption of tolerance level residues would result in predicted exposure at an unsafe level of exposure. Data, using single serving samples of a raw agricultural commodity, on the level or residue in food as consumed would be used to obtain a more precise estimate of potential dietary exposure. These data may also include washing, cooking, processing or degradation studies as well as market basket surveys for a more precise residue determination.
17. The proposed tolerance must reflect the maximum residue likely to occur in crops, in meat, milk, poultry, or eggs.
18. Required when a residue analytical method is required.