40 C.F.R. § 158.2081

Current through September 30, 2024
Section 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.

Table-EUP Biochemical Pesticides Product Chemistry Data Requirements

Guideline NumberData RequirementAll Use PatternsTest SubstanceTest Notes
MP EP
Product Identity and Composition
880.1100Product identity and compositionRTGAI, MPTGAI, EP1, 2
880.1200Description of starting materials, production and formulation processRTGAI, MPTGAI, EP2, 3
880.1400Discussion of formation of impuritiesRTGAI and MPTGAI and EP4
Analysis and Certified Limits
830.1700Preliminary analysisCRTGAI and MPTGAI and EP5, 8
830.1750Certified limitsRMPEP6
830.1800Enforcement analytical methodRMPEP7
Physical and Chemical Characteristics
830.6302ColorRTGAITGAI8
830.6303Physical stateRTGAI and MPTGAI and EP8
830.6304OdorRTGAITGAI8
830.6313Stability to normal and elevated temperatures, metals and metal ionsRTGAITGAI8, 17
830.6315FlammabilityCRMPEP9
830.6317Storage stabilityRMPEP-
830.6319MiscibilityCRMPEP10
830.6320Corrosion characteristicsRMPEP-
830.7000pHCRTGAI and MPTGAI and EP8, 11
830.7050UV/Visible light absorptionRTGAITGAI-
830.7100ViscosityCRMPEP12
830.7200Melting point/melting rangeCRTGAITGAI8, 13
830.7220Boiling point/boiling rangeCRTGAITGAI8, 14
830.7300Density/relative density/bulk densityRTGAI and MPTGAI and EP8, 18
830.7520Particle size, fiber length, and diameter distributionCRTGAITGAI8, 15
830.7550
830.7560
830.7570
Partition coefficient (n-Octanol /Water)CRTGAITGAI16
830.7840Water solubilityRTGAITGAI8
830.7950Vapor pressureRTGAITGAI8, 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 ([GREATER THAN]10-6g/l) and fibrous test substances with diameter [GREATER THAN EQUAL TO]0.1 [MICRO]m.
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.

40 C.F.R. §158.2081