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Electronic Code of Federal Regulations

e-CFR Data is current as of October 30, 2014

Title 40Chapter ISubchapter EPart 158Subpart V → §158.2120


Title 40: Protection of Environment
PART 158—DATA REQUIREMENTS FOR PESTICIDES
Subpart V—Microbial Pesticides


§158.2120   Microbial pesticides product analysis data requirements table.

(a) General. Sections 158.100 through 158.130 describe how to use this table to determine the product analysis data requirements and the substance to be tested for a particular microbial pesticide. Notes that apply to an individual test and include specific conditions, qualifications, or exceptions to the designated test are identified in paragraph (d) of this section.

(b) 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; All = All of the above.

(c) Table. The table in this paragraph shows the data requirements for microbial pesticides product analysis. The test notes are shown in paragraph (d) of this section.

Table—Microbial Pesticides Product Analysis Data Requirements

Test guideline No.Data requirementAll use
patterns
Test substanceTest notes
MPEP
Product Chemistry and Composition
885.1100Product identityRMPEP
885.1200Manufacturing processRTGAI and MPTGAI and EP
885.1250Deposition of a sample in a nationally recognized culture collectionRTGAITGAI1
885.1300Discussion of formation of unintentional ingredientsRTGAI and MPTGAI and EP
Analysis and Certified Limits
885.1400Analysis of samplesRTGAI and MPTGAI and EP2
885.1500Certification of limitsRMPEP
Physical and Chemical Characteristics
830.6302ColorRTGAITGAI
830.6303Physical stateRTGAITGAI
830.6304OdorRTGAITGAI
830.6313Stability to normal and elevated temperatures, metals, and metal ionsRTGAITGAI
830.6317Storage stabilityRTGAI and MPTGAI and EP
830.6319MiscibilityRMPEP3
830.6320Corrosion characteristicsRMPEP4
830.7000pHRTGAITGAI
830.7100ViscosityRMPEP5
830.7300Density/relative density/bulk density (specific gravity)RTGAITGAI

(d) Test notes. The following test notes are applicable to the data requirements for microbial pesticides product analysis as referenced in the last column of the table contained in paragraph (c) of this section.

1. Required for each isolate of a microbial pesticide. Isolates must be deposited with an agreement to ensure that the sample will be maintained and will not be discarded for the duration of the associated registration(s).

2. Required to support registration of each manufacturing-use product and end-use product. This analysis must be conducted at the point in the production process after which there would be no potential for microbial contamination or microbial regrowth. For full registration, generally an analysis of samples is a compilation of batches, over a period of time, depending on the frequency of manufacturing.

3. Only required for emulsifiable liquid forms of microbial pesticides.

4. Required when microbial pesticides are packaged in metal, plastic, or paper containers.

5. Only required for liquid forms of microbial pesticides.

[72 FR 61002, Oct. 26, 2007, as amended at 77 FR 52612, Aug. 30, 2012]



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