Minn. R. 4770.3021 - MICROBIOLOGICAL AND MYCOTOXINS TESTING OF DRIED RAW CANNABIS

Subpart 1. Testing required.

Before being packaged, a representative sample from each batch of dried raw cannabis must be tested for microbiological contaminants and mycotoxins using an AOAC-approved technology using appropriate aseptic techniques

.

Subp. 2. Microbiological contaminant tests.

A dried raw cannabis sample passes the microbiological contaminant test if it meets the following standards for microbial and fungal limits in colony forming units per gram (CFU/g):

Standard
Total viable aerobic bacteria	< 105 CFU/g
Total yeast and mold	< 104 CFU/g
Total coliforms	< 103 CFU/g
Bile-tolerant gram-negative bacteria	< 103 CFU/g
Escherichia coli and salmonella species	Not detected in one gram

Subp. 3. Mycotoxin tests.

For purposes of the mycotoxin test, a dried raw cannabis sample passes if:

A. the total of aflatoxin B1, B2, G1, and G2 is less than 20 micrograms per kilogram of substance;

B. aflatoxin B1 does not exceed 5 micrograms per kilogram of substance; and

C. ochratoxin A is less than 20 micrograms per kilogram of substance.

Subp. 4. Remediation.

A manufacturer must comply with the requirements in this subpart when a sample fails to meet the standards for microbiological contaminant or mycotoxin testing.

A. If a sample from a batch of dried raw cannabis fails microbiological contaminant or mycotoxin testing, the manufacturer may attempt to remediate the batch one time and resubmit a batch sample for testing. If a batch of dried raw cannabis fails microbiological contaminant or mycotoxin testing after remediation, the manufacturer may:

(1) use the batch to make a medical cannabis concentrate if the processing method effectively sterilizes the batch, such as a method using a hydrocarbon-based solvent or a carbon dioxide closed loop system, or the processing method selectively removes the mycotoxins from the batch; or

(2) dispose of the batch as medical cannabis waste under part 4770.1200, subpart 2, item A.

B. A batch that is remediated in accordance with this subpart must be resampled and tested in accordance with this chapter.

Notes

Minn. R. 4770.3021

46 SR 1011