About GPO   |   Newsroom/Media   |   Congressional Relations   |   Inspector General   |   Careers   |   Contact   |   askGPO   |   Help  
Home   |   Customers   |   Vendors   |   Libraries  
The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government produced by the Office of the Federal Register (OFR) and the Government Publishing Office.

Parallel Table of Authorities and Rules for the Code of Federal Regulations and the United States Code
Text | PDF

Find, review, and submit comments on Federal rules that are open for comment and published in the Federal Register using Regulations.gov.

Purchase individual CFR titles from the U.S. Government Online Bookstore.

Find issues of the CFR (including issues prior to 1996) at a local Federal depository library.


Electronic Code of Federal Regulations

e-CFR data is current as of April 22, 2015

Title 40Chapter ISubchapter EPart 158Subpart V → §158.2120

Title 40: Protection of Environment
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
Test substanceTest notes
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
830.6303Physical stateRTGAITGAI
830.6313Stability to normal and elevated temperatures, metals, and metal ionsRTGAITGAI
830.6317Storage stabilityRTGAI and MPTGAI and EP
830.6320Corrosion characteristicsRMPEP4
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]

Need assistance?