158.2172—Experimental use permit microbial pesticides residue data requirements table.
(a) General.
Sections 158.100 through 158.130 describe how to use this table to determine the residue chemistry data requirements and the substance to be tested for a particular microbial pesticide. Specific conditions, qualifications, or exceptions to the designated test appear in (d) of this section, and the procedures 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 (d) 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 residue. The test notes are shown in paragraph (d) of this section.
| Guideline Number | Data Requirement | All Use Patterns | Test Substance Data to Support MP or EP | Test Notes |
|---|---|---|---|---|
| 885.2100 | Chemical Identity | CR | EP | 1 |
| 885.2200 | Nature of the Residue in plants | CR | EP | 1 |
| 885.2250 | Nature of the Residue in animals | CR | EP | 1 |
| 885.2300 | Analytical methods - plants | CR | TGAI | 1 |
| 885.2350 | Analytical methods-animals | CR | TGAI | 1 |
| 885.2400 | Storage Stability | CR | EP | 1 |
| 885.2500 | Magnitude of residue in plants | CR | EP | 1 |
| 885.2550 | Magnitude of residues in meat, milk, poultry, eggs | CR | EP | 1 |
| 885.2600 | Magnitude of residues in potable water, fish, and irrigated crops | CR | EP | 1 |
(d) Test notes.
The following test note is applicable to the data requirements for experimental use permit microbial pesticides residue as referenced in the last column of the table contained in paragraph (c) of this section.
1. Required when the results of testing:
i. Indicate the potential to cause adverse human health effects or the product characterization indicates the microbial pesticide has a significant potential to produce a mammalian toxin; and
ii. The use pattern is such that residues may be present in or on food or feed crops.