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Electronic Code of Federal Regulations

e-CFR data is current as of November 12, 2019

Title 40Chapter ISubchapter EPart 158Subpart D → §158.310


Title 40: Protection of Environment
PART 158—DATA REQUIREMENTS FOR PESTICIDES
Subpart D—Product Chemistry


§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
830.1550Product identity and compositionRMPEP1
830.1600Description of materials used to produce the productRMPEP2
830.1620Description of production processRMPEP3
830.1650Description of formulation processRMPEP4
830.1670Discussion of formulation of impuritiesRMP, and possibly TGAIEP, and possibly TGAI5
830.1700Preliminary analysisCRMP, and possibly TGAIEP, and possibly TGAI6, 9, 10
830.1750Certified limitsRMPEP7
830.1800Enforcement analytical methodRMPEP8
830.1900Submittal of samplesCRMP, PAI and TGAIEP, PAI, TGAI9, 11
Physical and Chemical Properties
830.6302ColorRMP and TGAIEP9
830.6303Physical stateRMP and TGAIEP and TGAI9
830.6304OdorRMP and TGAIEP9
830.6313Stability to normal and elevated temperatures, metals, and metal ionsRMP and TGAIEP9, 12, 26
830.6314Oxidation/reduction: chemical incompatibilityCRMPEP13
830.6315FlammabilityCRMPEP14
830.6316ExplodabilityCRMPEP15
830.6317Storage stabilityRMPEP   
830.6319MiscibilityCRMPEP16
830.6320Corrosion characteristicsRMPEP   
830.6321Dielectric breakdown voltageCRNREP17
830.7000pHCRMP and TGAIEP and TGAI9, 18
830.7050UV/visible light absorptionRTGAI or PAINR--
830.7100ViscosityCRMPEP19
830.7200Melting point/melting rangeRTGAI or PAITGAI or PAI9, 20
830.7220Boiling point/boiling rangeRTGAI or PAITGAI or PA9, 21
830.7300Density/relative density/bulk densityRMP and TGAIEP and TGAI9
830.7370Dissociation constants in waterRTGAI or PAITGAI or PAI9, 22
830.7520Particle size, fiber length, and diameter distributionCRTGAI or PAIEP23
830.7550
830.7560
830.7570
Partition coefficient (n-octanol/water)RTGAI or PAITGAI or PAI24
830.7840
830.7860
Water solubilityRTGAI or PAITGAI or PAI9
830.7950Vapor pressureRTGAI or PAITGAI or PAI9, 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.

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