N.M. Admin. Code § 16.8.2.48

Current through Register Vol. 35, No. 21, November 5, 2024

Section 16.8.2.48 - MINIMUM STANDARDS FOR THE TESTING OF CANNABIS PRODUCTS

A.General requirements: Cannabis testing laboratories shall ensure the following:

(1) testing is done in premises that are in compliance with state and local laws that do not conflict with the Cannabis Regulation Act or the Lynn and Erin Compassionate Use Act; and

(2) weighting or measuring devices that are used in testing are appropriately documented as having undergone certified registration and calibration that is in accordance with requirements of the New Mexico department of agriculture applicable to commercial transactions.

B.Sample collection: For all required testing or testing for the purposes of labeling claims, a person authorized by this rule shall collect the required samples according to the following guidelines:

(1) Only the quantity of cannabis product specified in the cannabis testing laboratory's operating procedures as necessary for all tests to be performed and to ensure the proper number of representative samples shall be collected.

(2) The number of sample increments per batch, as specified in the cannabis testing laboratory's operating procedures as necessary for all tests to be performed, shall be collected.

(a) The number of sample increments shall not be less than the minimum quantity specified in Table 2.

(b) Samples shall be taken randomly throughout the length, width, and depth of the batch.

(c) The standard sample increment size shall be 0.5 grams, unless specified otherwise in the cannabis testing laboratory's operating procedures.

(3) Samples from the same batch shall be secured in a single use, tamper-evident container that meets the specifications of the laboratory's policies and procedures.

(4) Samples shall be labeled according to the laboratory's policies and procedures, with, at minimum:

(a) the license number of the establishment from which the sample was collected;

(b) the batch number assigned by the establishment;

(c) the date the sample was taken;

(d) the name of the person collecting the sample; and

(e) the tests to be performed;

(5) If homogeneity testing is required, each sample increment necessary for homogeneity testing shall be collected and transported in individual sealed containers.

Table 1. Minimum quantity of sample increments
Matrix Type	Batch Size	Minimum Sample Increments
Dried cannabis	<=5.0 lbs.	10
	>5.0 lbs.; <=15.0 lbs.	10 + 5 per pound or fraction thereof above 5 pounds
Other products	<=2.0 lbs.	10
	>2.0 lbs.	5 per pound

C.Transportation: All samples shall be transported according to the general requirements of 16.8.2.13 NMAC and the specifications found in the cannabis testing laboratory's policies and procedures.

D.Receipt of test samples: A cannabis testing laboratory may receive test samples of cannabis products from any cannabis establishment, adult 21 years of age or older, qualified patient, or primary caregiver as authorized by this rule.

E.Storage: A cannabis testing laboratory shall segregate and store cannabis samples in a manner that prevents contamination or degradations and shall safeguard any cannabis products and cannabis waste against diversion.

(1) A cannabis testing laboratory shall provide one or more secure cabinets or vaults for the storage of cannabis samples, reference standards, and cannabis waste, and access shall be limited to persons authorized to conduct tests or dispose of cannabis waste.

(2) Cannabis samples shall be stored in environmental conditions that minimize physical or chemical degradation and microbial contamination, including protection from light, heat, and humidity. Any cannabis product that requires refrigeration shall be kept at a temperature no greater than 40 degrees Fahrenheit (4 degrees Celsius) prior to sample preparation.

F.Sample retention and disposal:

(1) Samples testing positive for a prohibited pesticide must be retained for a minimum of 30 days. All other samples must be retained for a minimum of 15 days. Upon notification from the division that samples are needed for an investigation by the division, a law enforcement agency, or another department, the cannabis testing laboratory shall retain the sample until further directed by the division.

(2) Any portion of a cannabis or cannabis-derived test sample that is not destroyed during analysis shall be:

(a) returned to the person who provided the sample;

(b) provided to the division, the state chemist laboratory (department of agriculture), or state laboratory division for additional testing;

(c) upon written notification to the department, used to make for internal quality control purposes; or

(d) destroyed in accordance with the wastage requirements of this rule.

G.Laboratory premises: A cannabis testing laboratory shall maintain the premises of the laboratory in a clean and orderly condition; shall equip the premises with such utensils and equipment as necessary to conduct the operations of the laboratory; and shall ensure adequate space for laboratory operations, sample storage, and document storage.

H.Equipment:

(1) Equipment used for the analysis of test samples shall be adequately inspected, cleaned, and maintained by laboratory staff, the manufacturer, or other trained persons according to manufacturer recommendations. Equipment used for the generation or measurement of data shall be adequately tested and calibrated on an appropriate schedule, as applicable.

(2) Laboratory operations shall document procedures setting forth in sufficient detail the methods and schedules to be used in the routine inspection, cleaning, maintenance, testing, and calibration of equipment, and shall specify, as appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The procedures shall designate the personnel responsible for the performance of each operation.

(3) Computer systems used for the analysis of samples, retention of data, sample tracking, calibration scheduling, management of reference standards, or other critical laboratory management functions shall ensure that electronic records, electronic signatures, and handwritten signatures executed to electronic records are trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper.

I.Reagents, solutions, and reference standards:

(1) A cannabis testing laboratory is authorized to possess reagents, solutions, and reference standards. Such items shall be:

(a) secured in accordance with the approved laboratory's storage policies;

(b) labeled to indicate identity, date received or prepared, and expiration or requalification date; and, where applicable, concentration or purity, storage requirements, and date opened;

(c) stored under appropriate conditions to minimize degradation or deterioration of the material; and

(d) used only within the item's expiration or requalification date.

(2) Deteriorated or outdated reagents and solutions shall be properly destroyed.

(3) A cannabis testing laboratory may:

(a) acquire commercial reference standards for cannabinoids and other chemicals or contaminants, for the exclusive purpose of conducting testing for which the laboratory is approved;

(b) internally produce reference standards, using standard analytical techniques to document the purity and concentration of the internally produced reference standards;

(c) obtain cannabis products from a cannabis establishment for the purpose of producing reference standards.

J.Recording of analytical data:

(1) A cannabis testing laboratory shall ensure that all data generated during the testing of a test sample, except data generated by automated data collection systems, is recorded directly, promptly, and legibly in ink.

(2) When automated data collection systems are used, the cannabis testing laboratory shall log the name of the individual performing the test.

(3) All data shall be annotated with the date of entry and signed or initialed by the person recording the data. Any change in entries shall be made so as not to obscure the original entry, shall indicate the reason for such change, and shall be dated and signed or initialed at the time of the change.

(4) Any change in an entry shall:

(a) be made so as not to obscure the original entry;

(b) indicate the reason for such change;

(c) be dated and signed or initialed at the time of the change; and

(d) be accompanied by a corrective action report to be made available to the division or the cannabis establishment that submitted the sample upon request for up to two years after the analysis is completed.

(5) For each final result reported, a cannabis testing laboratory shall verify that:

(a) any calculations or other data processing steps were performed correctly;

(b) the data meet any data quality requirements such as for accuracy, precision, linearity, etc.;

(c) any reference standards used were of the appropriate purity and within their expiration or requalification dates;

(d) any volumetric solutions were properly standardized before use; and

(e) any test or measuring equipment used has been properly tested, verified, and calibrated, and is within its verification or calibration period.

K.Data storage:

(1) A cannabis testing laboratory shall ensure that all raw data, documentation, protocols, and certificates of analysis associated with analysis of a test sample are retained for two years from the date of the completion of analysis.

(2) A cannabis testing laboratory shall designate an individual as responsible for records maintenance;

(3) A cannabis testing laboratory shall maintain the records identified in this section. Such records must be maintained:

(a) in a manner that allows retrieval as needed;

(b) under conditions of storage that minimize deterioration throughout the retention period; and

(c) in a manner that prevents unauthorized alteration.

(4) Only authorized personnel may access the records.

L.Data reporting:

(1) A certificate of analysis shall contain the following information:

(a) the date of receipt of the test sample;

(b) the description of the type or form of the test sample (leaf, flower, powder, oil, specific edible product, etc.);

(c) the batch number or code that is associated with the product batch and that is recorded in the track and trace system;

(d) the identity of the person who collected the sample;

(e) the date on which analysis occurred;

(f) the analytical method used, including at a minimum identification of the type of analytical equipment used (e.g., GC, HPLC, etc.);

(g) the analytical results, including units of measure where applicable;

(h) the identity of the supervisory or management personnel who reviewed and verified the data and results and ensured that data quality, calibration, and other applicable requirements were met; and

(i) the name, address, and contact information of the cannabis testing laboratory that conducted the test.

(2) The certificate of analysis shall state that reported analytical results apply only to the test sample received.

(3) The certificate of analysis shall contain in minimum 12-point type, all capital letters, the disclaimer, "UNOFFICIAL TEST RESULTS. NOT VALID FOR TRANSFER OR SALE" whenever:

(a) The person submitting the test sample is not a licensed cannabis establishment;

(b) The test sample was not collected by a person authorized to collect samples for required testing under this rule; or

(c) The person submitting the test sample requested that the analysis be performed for research and development purposes.

N.M. Admin. Code § 16.8.2.48

Adopted by New Mexico Register, Volume XXXII, Issue 01, January 11, 2022, eff. 1/11/2022