N.D. Admin Code 33-44-01-48 - Standards for microbiological contaminants and mycotoxin compliance testing

1. Usable marijuana required to be tested for microbiological contaminants under sections 33-44-01-42, 33-44-01-43, and 33-44-01-44 must be sampled using appropriate aseptic techniques.

2. For purposes of the microbiological test, a usable marijuana sample is deemed to have passed if it meets the following standards for microbial and fungal limits in colony forming units per gram (CFU/g):

Concentrates	Medical Cannabinoid Products
Total viable aerobic bacteria	104 CFU/g	105 CFU/g
Total yeast and mold	103 CFU/g	104 CFU/g
Total coliforms	102 CFU/g	103 CFU/g
Bile-tolerant gram-negative bacteria	102 CFU/g	103 C FU/g
Escherichia coli (pathogenic strains) and salmonella species	Not detected in one gram	Not detected in one gram

3. For purposes of the mycotoxin test, a usable marijuana sample is deemed to have passed if it meets the following standards:

a. The total of aflatoxin B1, B2, G1, and G2 is less than 20 µg/kg of substance; and

b. Ochratoxin A is less than 20 µg/kg of substance.

4. If the samples do not pass testing standards for microbiological contaminants or mycotoxins, the manufacturing facility shall comply with section 33-44-01-52.

Notes

N.D. Admin Code 33-44-01-48

Adopted by Administrative Rules Supplement 368, April 2018, effective 4/1/2018.

General Authority: NDCC 19-24.1-36

Law Implemented: NDCC 19-24.1-36