New Mexico Administrative Code
Title 7 - HEALTH
Chapter 34 - MEDICAL USE OF CANNABIS
Part 4 - LICENSING REQUIREMENTS FOR PRODUCERS, PRODUCTION FACILITIES AND DISTRIBUTION
Section 7.34.4.19 - DEPARTMENT-APPROVED TESTING LABORATORIES; INSTRUMENTATION; INITIAL AND CONTINUING DEMONSTRATIONS OF CAPABILITY
Current through Register Vol. 35, No. 18, September 24, 2024
A. Mycotoxin test instrumentation: A laboratory shall utilize HPLC, LCMS, or LCMSMS instrumentation to test for the presence of mycotoxins in usable cannabis and shall analyze for mycotoxins at a concentration as low as 1 µg/kg (ppb). Mycotoxin testing shall be conducted in accordance with the requirements of Table 2, Mycotoxins Testing Requirements.
B. Residual solvents test instrumentation: A laboratory shall utilize gas chromatography - flame ionization detector (GC-FID), gas chromatography tandem photoionization detector/flame ionization detector (GC-PID/FID), or GCMS instrumentation to test for the presence of residual solvents and shall analyze for residual solvents at a concentration as low as 2µg/g (ppm). Residual solvent testing shall be conducted in accordance with the requirements of Table 3, Residual Solvent Testing Requirements.
C. Potency test instrumentation: A laboratory shall utilize HPLC or LCMS instrumentation to test for potency in usable cannabis and shall analyze usable cannabis in accordance with the provisions at Table 4 Potency Testing Requirements.
D. Heavy metals test instrumentation: A laboratory shall utilize Inductively coupled plasma mass spectrometry (ICP-MS) or flow injection mercury system (FIMS) instrumentation to test for the presence of heavy metals in usable cannabis and shall analyze for heavy metals at a concentration as low as 0.2 µg/g (ppm) for lead (Pb) and cadmium (Cd), as low as 1.0 µg/g (ppm) for arsenic (As) and 0.1 µg/g (ppm) for mercury (Hg). Heavy metals testing shall be conducted in accordance with the requirements of Table 5, Heavy Metals Testing Requirements.
E. Pesticide test instrumentation: A laboratory shall utilize high performance liquid chromatography (HPLC), gas chromatography mass spectrometry (GCMS), liquid chromatography - mass spectrometry (LCMS), or liquid chromatography with tandem mass spectrometry (LCMSMS) instrumentation to test for the presence of pesticides in usable cannabis and shall analyze for pesticides at a concentration as low as 100 µg/kg (ppb). Pesticide testing shall be conducted in accordance with the provisions of Table 6, Pesticide Testing Requirements.
F. Initial and continuing demonstrations of capability required: A laboratory or laboratory applicant shall submit to the department an initial demonstration of capability (IDC) for every test identified in this rule that the laboratory or applicant intends to conduct. A laboratory shall submit a continuing demonstration of capability (CDC) annually as part of the laboratory's application for renewal of licensure. The IDC shall be submitted to the department prior to the laboratory or laboratory applicant conducting tests pursuant to this rule. Each IDC and CDC shall describe how quality control samples (negative control samples, positive control samples, low-positive controls, and instrument performance check controls), internal standards, and surrogate standards are to be assessed to determine if the data from an analytical batch are acceptable. The laboratory shall maintain a documented procedure for performing every IDC and CDC. The laboratory shall retain documentation verifying the IDC and CDC for each test required by this rule and make this documentation available to the department upon request. The IDC and CDCs shall follow the same parameters as outlined in the requirements of this rule. Every IDC and CDC that is submitted shall be conducted within one year of application (excluding mycotoxins).
G. Use of internal standards: A laboratory shall utilize an internal standard chemical compound in the instrumental analysis (testing methods) of cannabinoids, residual solvents, mycotoxins, heavy metals, and pesticides, which are collectively referred to as the tested analytes. The internal standard compound shall be used to determine the characteristic relative chromatographic retention times of these tested analytes to ensure proper analyte identifications (qualification) whenever mass spectral data are not obtained by an instrument. The internal standard compound shall be used to determine the relative instrument response of the tested analytes to ensure the proper measurement of analyte concentrations (quantitation).
H. Reporting results: A laboratory shall use no more than two significant figures to report a positive result. A laboratory shall report a non-detect of an analyte as less than the laboratory's minimum reporting level. A laboratory shall also report a pass or fail evaluation with the reported result. A pass evaluation is assigned to a reported result less than the analytes action level listed. A fail evaluation is assigned to a reported result equal to or greater than the action level for each given analysis, consistent with the requirements of this rule.