40 CFR § 158.310 - Product chemistry data requirements table.

§ 158.310 Product chemistry data requirements table.

(a) General. 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 (f) of the section.

(b) Use patterns. Product chemistry data are required for all pesticide products and are not use-specific.

(c) Test substance. Data requirements that list only the manufacturing-use product as the test substance apply to products containing solely the technical grade of the active ingredient and manufacturing-use products to which other ingredients have been intentionally added.

(d) Key. R = Required; CR = Conditionally required; MP = Manufacturing-use product; NR = Not required; EP = End-use product; TGAI = Technical grade of the active ingredient; PAI = Pure active ingredient.

(e) Table. The following table shows the data requirements for product chemistry. The table notes are shown in paragraph (f) of this section.

Product Chemistry Data Requirements

Guideline Number Data Requirement Use Pattern Test substance to support Test Note No.
All MP EP
Product Identity and Composition
830.1550 Product identity and composition R MP EP 1
830.1600 Description of materials used to produce the product R MP EP 2
830.1620 Description of production process R MP EP 3
830.1650 Description of formulation process R MP EP 4
830.1670 Discussion of formulation of impurities R MP, and possibly TGAI EP, and possibly TGAI 5
830.1700 Preliminary analysis CR MP, and possibly TGAI EP, and possibly TGAI 6, 9, 10
830.1750 Certified limits R MP EP 7
830.1800 Enforcement analytical method R MP EP 8
830.1900 Submittal of samples CR MP, PAI and TGAI EP, PAI, TGAI 9, 11
Physical and Chemical Properties
830.6302 Color R MP and TGAI EP 9
830.6303 Physical state R MP and TGAI EP and TGAI 9
830.6304 Odor R MP and TGAI EP 9
830.6313 Stability to normal and elevated temperatures, metals, and metal ions R MP and TGAI EP 9, 12, 26
830.6314 Oxidation/reduction: chemical incompatibility CR MP EP 13
830.6315 Flammability CR MP EP 14
830.6316 Explodability CR MP EP 15
830.6317 Storage stability R MP EP
830.6319 Miscibility CR MP EP 16
830.6320 Corrosion characteristics R MP EP
830.6321 Dielectric breakdown voltage CR NR EP 17
830.7000 pH CR MP and TGAI EP and TGAI 9, 18
830.7050 UV/visible light absorption R TGAI or PAI NR —
830.7100 Viscosity CR MP EP 19
830.7200 Melting point/melting range R TGAI or PAI TGAI or PAI 9, 20
830.7220 Boiling point/boiling range R TGAI or PAI TGAI or PA 9, 21
830.7300 Density/relative density/bulk density R MP and TGAI EP and TGAI 9
830.7370 Dissociation constants in water R TGAI or PAI TGAI or PAI 9, 22
830.7520 Particle size, fiber length, and diameter distribution CR TGAI or PAI EP 23
830.7550
830.7560
830.7570		 Partition coefficient (n-octanol/water) R TGAI or PAI TGAI or PAI 24
830.7840
830.7860		 Water solubility R TGAI or PAI TGAI or PAI 9
830.7950 Vapor pressure R TGAI or PAI TGAI or PAI 9, 25

(f) Test notes. The following test notes are applicable to the product chemistry data requirements in the table to paragraph (e) of this section:

1. Data must be provided in accordance with § 158.320.

2. Data must be provided in accordance with § 158.325.

3. Data must be provided in accordance with § 158.330.

4. Data must be provided in accordance with § 158.335.

5. Data must be provided in accordance with § 158.340.

6. Data must be provided in accordance with § 158.345.

7. Data must be provided in accordance with § 158.350.

8. Data must be provided in accordance with § 158.355.

9. If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI.

10. Data are required if the product is produced by an integrated system.

11. Basic manufacturers are required to provide the Agency with a sample of each TGAI used to formulate a product produced by an integrated system when the new TGAI is first used as a formulating ingredient in products registered under FIFRA. A sample of the active ingredient (PAI) suitable for use as an analytical standard is also required at this time. Samples of end-use products produced by an integrated system must be submitted on a case-by-case basis.

12. Data on the stability to metals and metal ions are required only if the TGAI is expected to come into contact with either material.

13. Required when the product contains an oxidizing or reducing agent.

14. Required when the product contains combustible liquids.

15. Required when the product is potentially explosive.

16. Required when the product is an emulsifiable liquid and is to be diluted with petroleum solvent.

17. Required when the EP is a liquid and is to be used around electrical equipment.

18. Required when the test substance is soluble or dispersible in water.

19. Required when the product is a liquid.

20. Required when the TGAI is solid at room temperature.

21. Required when the TGAI is liquid at room temperature.

22. Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).

23. Required for water insoluble test substances (>10−6 g/l) and fibrous test substances with diameter of ≥0.1 µm.

24. Required if technical chemical is organic and non-polar.

25. Not required for salts.

26. Data on stability of the MP and TGAI to storage at normal temperatures are required. Data on the stability of the TGAI to high temperatures are required if the TGAI is expected to be subjected to temperatures >50 °C (122 °F) during production or storage.