158.2081—Experimental use permit biochemical pesticides product chemistry data requirements table.
(a) General.
(1)
Sections 158.100 through 158.130 describe how to use this table to determine the product chemistry data requirements for a particular biochemical pesticide product. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are listed in paragraph (e) of the section.
(2)
Depending on the results of the required product chemistry studies, appropriate use restrictions, labeling requirements, or special packaging requirements may be imposed.
(b) Use patterns.
Product chemistry data are required for all pesticide products and are not use specific.
(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 product chemistry. The test notes are shown in paragraph (e) of this section.
| Guideline Number | Data Requirement | All Use Patterns | Test Substance | Test Notes | |
|---|---|---|---|---|---|
| MP | EP | ||||
| Product Identity and Composition | |||||
| 880.1100 | Product identity and composition | R | TGAI, MP | TGAI, EP | 1, 2 |
| 880.1200 | Description of starting materials, production and formulation process | R | TGAI, MP | TGAI, EP | 2, 3 |
| 880.1400 | Discussion of formation of impurities | R | TGAI and MP | TGAI and EP | 4 |
| Analysis and Certified Limits | |||||
| 830.1700 | Preliminary analysis | CR | TGAI and MP | TGAI and EP | 5, 8 |
| 830.1750 | Certified limits | R | MP | EP | 6 |
| 830.1800 | Enforcement analytical method | R | MP | EP | 7 |
| Physical and Chemical Characteristics | |||||
| 830.6302 | Color | R | TGAI | TGAI | 8 |
| 830.6303 | Physical state | R | TGAI and MP | TGAI and EP | 8 |
| 830.6304 | Odor | R | TGAI | TGAI | 8 |
| 830.6313 | Stability to normal and elevated temperatures, metals and metal ions | R | TGAI | TGAI | 8, 17 |
| 830.6315 | Flammability | CR | MP | EP | 9 |
| 830.6317 | Storage stability | R | MP | EP | -- |
| 830.6319 | Miscibility | CR | MP | EP | 10 |
| 830.6320 | Corrosion characteristics | R | MP | EP | -- |
| 830.7000 | pH | CR | TGAI and MP | TGAI and EP | 8, 11 |
| 830.7050 | UV/Visible light absorption | R | TGAI | TGAI | -- |
| 830.7100 | Viscosity | CR | MP | EP | 12 |
| 830.7200 | Melting point/melting range | CR | TGAI | TGAI | 8, 13 |
| 830.7220 | Boiling point/boiling range | CR | TGAI | TGAI | 8, 14 |
| 830.7300 | Density/relative density/bulk density | R | TGAI and MP | TGAI and EP | 8, 18 |
| 830.7520 | Particle size, fiber length, and diameter distribution | CR | TGAI | TGAI | 8, 15 |
| 830.7550830.7560 830.7570 | Partition coefficient (n-Octanol /Water) | CR | TGAI | TGAI | 16 |
| 830.7840 | Water solubility | R | TGAI | TGAI | 8 |
| 830.7950 | Vapor pressure | R | TGAI | TGAI | 8, 19 |
(e) Test notes.
The following test notes are applicable to the data requirements for experimental use permit biochemical pesticides product chemistry and are referenced in the last column of the table in paragraph (d) of this section.
1. Data must be provided in accordance with § 158.320.
2. If the MP and EP are produced by an integrated formulation system (non-registered source), these data are also required on TGAI.
3. Data must be provided in accordance with § 158.325, § 158.330, and § 158.335.
4. Data must be provided in accordance with § 158.340.
5. Data must be provided in accordance with § 158.345. Also, required to support the registration of each manufacturing-use product (including registered TGAIs) and end-use products produced by an integrated formulation system. Data on other end-use products would be required on a case-by-case basis. For pesticides in the production stage, a preliminary product analytical method and data would suffice to support an experimental use permit.
6. Data must be provided in accordance with § 158.350.
7. Data must be provided in accordance with § 158.355.
8. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI. EP testing may also be appropriate.
9. Required if the product contains combustible liquids.
10. Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
11. Required if the test substance is soluble or dispersible in water.
12. Required if the product is a liquid.
13. Required when the technical chemical is a solid at room temperature.
14. Required when the technical chemical is a liquid at room temperature.
15. Required for water insoluble test substances (>10-6g/l) and fibrous test substances with diameter ≥0.1 µm.
16. Required for organic chemicals unless they dissociate in water or are partially or completely soluble in water.
17. Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
18. True density or specific density are required for all test substances. Data on bulk density is required for MPs or EPs that are solid at room temperature.
19. Not required for salts.