Minnesota Administrative Rules

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 five 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.

Statutory Authority:

MS s 14.389

History:

46 SR 1011

Published Electronically:

June 15, 2022