(1) Mycotoxin testing is intended to accurately measure semi-quantitative or quantitate results, and report mycotoxins incurred through the production and processing of cannabis and cannabis products.
(2) For semi-quantitative or qualitative methods, the laboratory may report negative results. The limit of detection must be equal to or less than the analyte limit. Positive detections must be confirmed and reported using a quantitative method.
(3) For quantitative methods, the laboratory may only report numerical results that are above the limit of quantification and below the upper limit of linearity.
(4) The analytical processes for mycotoxin testing must include the following:
(a) A matrix negative and a matrix positive for each sample matrix tested per batch;
(b) Matrix positive controls at relevant levels above the decision point;
(c) The laboratory must perform a second-source calibration verification (ICV) above the decision point concentration.
(5) For high complexity testing, additional quality control is required.
(a) ICV, CCV, and surrogate must meet a minimum of 70 - 130 percent recovery for each analyte.
(b) Matrix spike samples must meet a minimum of 70 - 130 percent recovery for each analyte.
(c) Sample and matrix duplicates must have a relative percent difference (RPD) value of less than 20 percent.
(6) Analyze matrix spike duplicates or sample duplicates at a frequency of one in 20 samples per matrix, per sample extraction or preparation method, to measure repeatability and precision of the mycotoxin assay(s).
(7) Mass spectrometry testing criteria.
(a) A minimum of three structurally significant ions (meeting the three to one signal to noise ratio) are required for confirmation. If instrument conditions or ionization techniques limit the number of ions available, the laboratory may request a deviation from the department in order to report results under these conditions.
(b) The confidence limits of the relative abundance of structurally significant ions and precursor-to-product ion transitions used for single ion monitoring and multiple reaction monitoring must be ± 30 percent (relative) when compared to the same relative abundances observed from a standard solution injection made during the same analytical run.
(8) The laboratory must have procedures that include the following:
(a) Special safety precautions required for handling mycotoxin standards;
(b) Mycotoxin standards may only be opened and used within a certified fume hood;
(c) A mycotoxin spill cleanup procedure must be included;
(d) The laboratory must ensure stability of mycotoxin standards;
(e) A detailed description of how potentially hazardous waste is disposed of.