158.2171—Experimental use permit 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. Specific conditions, qualifications, or exceptions to the designated test are identified in (d) of this section, and the test notes appear in paragraph (e) 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. 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:
(c) Table.
The following table shows the data requirements for experimental use permit microbial pesticides product analysis. The test notes are shown in paragraph (d) of this section.
| Guideline Number | Data Requirement | All Use Patterns | Test Substance | Test Notes | |
|---|---|---|---|---|---|
| MP | EP | ||||
| Product Chemistry and Composition | |||||
| 885.1100 | Product Identity | R | MP | EP | -- |
| 885.1200 | Manufacturing process | R | TGAI and MP | TGAI and EP | 1, 2 |
| Deposition of a sample in a nationally recognized culture collection | R | TGAI | TGAI | -- | |
| 885.1300 | Discussion of formation of unintentional ingredients | R | TGAI and MP | TGAI and EP | 2 |
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| Analysis and Certified Limits | |||||
| 885.1400 | Analysis of samples | R | TGAI and MP | TGAI and EP | 2, 3 |
| 885.1500 | Certification of limits | R | MP | EP | -- |
| Physical and Chemical Characteristics | |||||
| 830.6302 | Color | R | TGAI | TGAI | -- |
| 830.6303 | Physical state | R | TGAI | TGAI | -- |
| 830.6304 | Odor | R | TGAI | TGAI | -- |
| 830.6313 | Stability to normal and elevated temperatures, metals and metal ions | R | TGAI | TGAI | -- |
| 830.6317 | Storage stability | R | TGAI and MP | TGAI and EP | -- |
| 830.6319 | Miscibility | R | MP | EP | 4 |
| 830.6320 | Corrosion Characteristics | R | MP | EP | 5 |
| 830.7000 | pH | R | TGAI | TGAI | -- |
| 830.7100 | Viscosity | R | MP | EP | 6 |
| 830.7300 | Density/relative density/bulk density (specific gravity) | R | TGAI | TGAI | -- |
(d) Test notes.
The following test notes are applicable to the data requirements for experimental use permit microbial pesticides product analysis as referenced in the last column of the table contained in paragraph (c) of this section.
1. If an experimental use permit is being sought, and if the pesticide is not already under full-scale production, a schematic diagram and/or description of the manufacturing process suffices.
2. If an experimental use permit is being sought, and if the product is not already under full-scale production, a discussion of unintentional ingredients is required to be submitted to the extent this information is available.
3. 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 pesticides in the production stage, a preliminary product analytical method and data would suffice to support an experimental use permit. For full registration, generally an analysis of samples is a compilation of batches, over a period of time, depending on the frequency of manufacturing.
4. Only required for emulsifiable liquid forms of microbial pesticides.
5. Required when microbial pesticides are packaged in metal, plastic, or paper containers.
6. Only required for liquid forms of microbial pesticides.