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

Current through Supplement No. 394, October, 2024
Section 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.

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