40 CFR 158.2030 - Biochemical pesticides product chemistry data requirements table.

§ 158.2030 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 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) Definitions in § 158.300 apply to data requirements in this section.
(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.
(d) Table. The following table shows the data requirements for biochemical pesticides product chemistry. The test notes are shown in paragraph (e) of this section.
Table—Biochemical Pesticides Product Chemistry Data Requirements
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 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.
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.

Title 40 published on 2013-07-01

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