§ 158.2120 - Microbial pesticides product analysis data requirements table.

§ 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 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
885.1250	Deposition of a sample in a nationally recognized culture collection	R	TGAI	TGAI	1
885.1300	Discussion of formation of unintentional ingredients	R	TGAI and MP	TGAI and EP
Analysis and Certified Limits
885.1400	Analysis of samples	R	TGAI and MP	TGAI and EP	2
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	3
830.6320	Corrosion characteristics	R	MP	EP	4
830.7000	pH	R	TGAI	TGAI
830.7100	Viscosity	R	MP	EP	5
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 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]