New Mexico Register / Volume XXXIII, Issue 1 / January 11, 2022

 

 

This is an amendment to 16.8.2 NMAC, renumbering Section 43 to Section 49 and adding new Sections 43 through 48, effective 01/11/2022.

 

16.8.2.43               CANNABIS TESTING LABORATORY LICENSE: GENERAL PROVISIONS:

                A.            Testing categories: The division may license cannabis testing laboratories to perform analytical testing of cannabis products in one or more of the following categories:

                                (1)           visual inspection;

                                (2)           microbiological;

                                (3)           residual solvents;

                                (4)           potency and homogeneity;

                                (5)           heavy metals;

                                (6)           pesticides; and

                                (7)           such other testing categories as the department may identify.

                B.            License not required for internal testing: A cannabis establishment may conduct analytical testing using validated methods for internal quality control purposes without obtaining a cannabis testing laboratory license but may not offer testing services to another person or entity.

                C.            Division application forms: All applications for licensure authorized pursuant to the Cannabis Regulation Act shall be made upon current forms prescribed by the division using the online application portal.

                D.            Other activities prohibited: No person with a direct or indirect interest in any cannabis establishment other than a cannabis research laboratory may hold an interest in a cannabis testing laboratory.

[16.8.2.43 NMAC – Rp, 16.8.2.43 NMAC, 01/11/2022]

 

16.8.2.44               APPLICATION REQUIREMENTS FOR CANNABIS TESTING LABORATORY LICENSE:

                A.            Contents of application:

                                (1)           for any initial or renewal application, contact information for the applicant and the cannabis establishment, to include:

                                                (a)           applicant’s full legal name;

                                                (b)           applicant’s mailing address;

                                                (c)           applicant’s contact telephone number;

                                                (d)           applicant’s contact email address;

                                                (e)           applicant’s business physical address and mailing address, if different;

                                                (f)            applicant’s business legal name, including a DBA name, if applicable;

                                                (g)           applicant’s business web address, if applicable;

                                (2)           for any initial application, information about controlling persons, to include:

                                                (a)           name and contact information;

                                                (b)           documentation of legal name change, if applicable;

                                                (c)           criminal history screening documents. as set forth in 16.8.2.9 NMAC and the Cannabis Regulation Act;

                                                (d)           a detailed description of any criminal convictions, including for each: the date of the conviction; dates of incarceration, probation, or parole; description of the offense; and any evidence of rehabilitation, including court documents, personal or professional references, completion of treatment, employment records, and other relevant information;

                                                (e)           demographic data pursuant to the Cannabis Regulation Act; and

                                                (f)            A copy of identification issued by a federal or state government, including name, date of birth, and picture and indicating the person is at least 21 years of age;

                                (3)           for any renewal application, certifications that the applicant:

                                                (a)           attests to the following statement: Under penalty of perjury, I hereby declare that the information contained within and submitted with the application is complete, true and accurate. I understand that a misrepresentation of fact or violation of these rules may result in denial of the license application or revocation of a license issued;

                                                (b)           will adhere to the Cannabis Regulation Act, the Lynn and Erin Compassionate Use Act, and division rules, including:

                                                                (i)            testing requirements;

                                                                (ii)           transport requirements;

                                                                (iii)         security requirements;

                                                                (iv)          quality assurance requirements; and

                                                                (v)           the prohibition on any person holding an interest in one or more cannabis testing laboratories from holding an interest in any other cannabis license other than a cannabis research laboratory;

                                                (c)           will adhere to applicable federal, state and local laws governing the protection of public health and the environment, including occupational health and safety, food safety, fire safety, environmental impacts, natural resource protections, air quality, solid and hazardous waste management, and wastewater discharge;

                                                (d)           has never been denied a license or had a license suspended or revoked by the division or any other state cannabis licensing authority or a detailed description of any administrative orders, civil judgements, denial or suspension of a cannabis license, revocation of a cannabis license, or sanctions for unlicensed cannabis activity by any state licensing authority, against the applicant, controlling person, or a business entity in which the applicant or controlling person was a controlling person within the three years immediately preceding the date of the application; and

                                                (e)           is not licensed at the same location under the Liquor Control Act;

                                                (f)            has obtained a current local jurisdiction business license, or will prior to operation of the cannabis establishment, and the applicant shall adhere to local zoning ordinance

                                (4)           for any initial application, and, unless a statement is included that no material changes exist, for any renewal application:

                                                (a)           a list of categories of testing for which licensure is sought;

                                                (b)           legible and accurate premises diagram containing information required by 16.8.2.46 NMAC, in a portable document format (.pdf), and if requested by the division, digital photographs;

                                                (c)           applicant’s social and economic equity plan to encourage economic and social diversity in employment, including race, ethnicity, gender, age, and residential status of licensee, controlling persons and employees of applicant and whether the applicant, controlling persons, employees, or premises are located in an underserved rural community, including tribal, acequia, land grant-merced, federally designated opportunity zone, or other rural historic communities; and

                                (5)           for any initial or renewal application, payment of any required fees as set forth in 16.8.11 NMAC.

                B.            Initial demonstration of capability: The division requires the submission of an initial demonstration of capability (IDC) for every test a cannabis testing laboratory intends to conduct, except tests for research and development purposes only. The IDC must identify a limit of quantitation that is equal to or lower than the action level for the specified test.

                                (1)           An IDC is required whenever:

                                                (a)           an initial application is submitted, except that an applicant may instead submit evidence of prior completion of an IDC as a requirement of licensing under the Lynn and Erin Compassionate Use Act;

                                                (b)           the cannabis testing laboratory proposes to use a new analytical instrument to test for an analyte; or

                                                (c)           the cannabis testing laboratory proposes material changes to testing methods.

                                (2)           Every IDC shall include the following elements:

                                                (a)           Demonstration of method calibration: The calibration range shall use at least five calibration points consisting of five different concentration levels of target compounds. The calibration range shall include a low calibration point equal to, or less than, the action level for each targeted compound. The cannabis testing laboratory shall provide the equation and the type of curve fit used for the calibration range, and the percent relative standard deviation or the goodness of fit. The percent relative standard deviation shall be less than twenty percent, or the goodness of fit (correlation coefficient) shall be 0.995 or better.

                                                (b)           Demonstration of method accuracy and precision: A cannabis testing laboratory shall supply the quantitation data for five positive control samples analyzed by its testing method utilizing median or mid-level calibration concentration. The cannabis testing laboratory shall identify and justify acceptance criteria and shall calculate and provide the calculated mean (average) result and the standard deviation. Any standard deviations greater than twenty percent shall be noted and explained.

                                                (c)           Demonstration of method detection limit: A cannabis testing laboratory shall calculate its method detection limit using a generally accepted method.

                                                (d)           Demonstration of low system background: A cannabis testing laboratory shall supply the analytical data of at least three negative control samples that do not contain any target analytes.

                                                (e)           Demonstration of analyte identification: A cannabis testing laboratory that uses, high performance liquid chromatography (HPLC) or gas chromatography with flame ionization detector or photoionization detector (GC-FID or GC-PID/FID) instrumentation shall supply analytical data where each targeted compound is analyzed as a single compound giving it its characteristic retention time. A cannabis testing laboratory that uses gas chromatography–mass spectrometry (GCMS), liquid chromatography–mass spectrometry (LCMS), or liquid chromatography–tandem mass spectrometry (LCMSMS) instrumentation shall supply analytical data with the characteristic mass spectrum of each targeted compound.

                C.            Continuing demonstration of capability: A cannabis testing laboratory shall submit a continuing demonstration of capability (CDC) for each test performed annually as part of the laboratory’s application for renewal of licensure. A CDC may consist of:

                                (1)           Evidence that the cannabis testing laboratory has the test within its current scope of accreditation to the current standards of ISO/IEC 17025, Testing and Calibration Laboratories;

                                (2)           Evidence that each analyst performing the test has successfully completed, within the previous year, relevant proficiency testing administered by a provider accredited to the standards of ISO/IEC 17043, Conformity Assessment—General Requirements for Proficiency Testing; or

                                (3)           The re-performance of the IDC.

                D.            Verification of information: The division may verify information contained in each application and accompanying documentation by:

                                (1)           contacting the applicant or controlling person by telephone, mail, or electronic mail;

                                (2)           conducting an on-site visit;

                                (3)           requiring a face-to-face or virtual meeting and the production of additional documentation; or

                                (4)           consulting with state or local governments.

                E.            Trade secrets: Any applicant submitting operating procedures and protocols to the division pursuant to the Lynn and Erin Compassionate Use Act, the Cannabis Regulation Act, or division rules, may claim such information as a trade secret by clearly identifying such information as “confidential trade secrets” on the document at the time of submission. Any claim of confidentiality by an applicant must be based on the applicant’s good faith belief that the information marked as confidential constitutes a trade secret as defined in the Uniform Trade Secrets Act, Sections 57-3A-1 to -7, NMSA 1978. In the event the division receives a request to inspect such documents, the division will notify the applicant or licensee, via the current email of record. If the division does not receive an injunction pursuant to the Uniform Trade Secrets Act within five days of the request to inspect, the division will make the documents marked confidential available for inspection as required pursuant to the Inspection of Public Records Act.

[16.8.2.44 NMAC – N, 01/11/2022]

 

16.8.2.45               SUBMITTAL OF APPLICATION FOR AMENDED CANNABIS TESTING LABORATORY LICENSE:

                A.            Application: A cannabis testing laboratory shall submit to the division an application form for an amended license and obtain approval from the division, prior to implementing any of the following:

                                (1)           material or substantial change of the size of the premises;

                                (2)           change of licensee’s legal or business name;

                                (3)           material or substantial change in testing methods or equipment;

                                (4)           addition or elimination of a controlling person;

                                (5)           material or substantial change to a licensee’s security system; or

                                (6)           material or substantial modification of the premises.

                B.            Requirements and processing of application for amended license: The application for amended license shall:

                                (1)           be clearly designated as one for an amended license;

                                (2)           supply any information representing a material change from the most recent application; and

                                (3)           include an initial demonstration of capability for any new or materially different method for performing a required test, including testing for an additional analyte or testing for an analyte using a different type of instrument.

                C.            Approval or denial: The division shall approve or deny an application for amended license within 90 days of receiving a completed application. Denial of an application for amendment shall be pursuant to the Uniform Licensing Act.

                D.            Material or substantial change: Material or substantial changes requiring approval include:

                                (1)           increase or decrease in the size of the premises, including the sale of property used for the cannabis establishment, the purchase of additional property for the use of the cannabis establishment, or a change in the location of the cannabis establishment;

                                (2)           testing for an analyte required in required testing using a different type of instrument; or

                                (3)           change to a licensee’s security system, including relocation of security points or installation of a new security system.

                E.            Amended license not required: Other changes to standard operating policies and procedures, unless material or substantial, may be made without providing notification to the division, provided that licensees shall maintain at each licensed premises a copy of all current and prior operating policies and procedures.

[16.8.2.45 NMAC – N, 01/11/2022]

 

16.8.2.46               PREMISES DIAGRAM:

                A.            Detailed diagram required: An applicant must submit to the division, with the application, a complete and detailed diagram of the proposed premises. The diagram shall be used by the division to determine whether the premises meets the requirements of the Cannabis Regulation Act, the Lynn and Erin Compassionate Use Act, and division rules. The division shall deny an application if the premises does not qualify for licensure pursuant to federal, state, or local laws.

                B.            Contents of diagram: The diagram shall show:

                                (1)           the boundaries of the property and the proposed premises to be licensed;

                                (2)           if applicable, the uses of any portion of the property not included in the premises;

                                (3)           a brief statement or description of the principal activity to be conducted in each area on the premises;

                                (4)           the dimensions of each area where testing of cannabis products will take place;

                                (5)           the location and identity of equipment; and

                                (6)           entrances and exits;

                C.            Format of diagram: The diagram shall:

                                (1)           be drawn to scale;

                                (2)           be rendered in black and white print; and

                                (3)           contain no highlighting.

[16.8.2.46 NMAC – N, 01/11/2022]

 

16.8.2.47               CANNABIS TESTING LABORATORY POLICIES AND PROCEDURES:

                A.            Minimum policy and procedure requirements: A cannabis testing laboratory shall develop, implement, and maintain on the licensed premises, standard policies and procedures, which shall include the following:

                                (1)           sample collection procedures, including:

                                                (a)           specifications for sampling tools and containers;

                                                (b)           use of gloves and other personal protective equipment to prevent contamination of batches;

                                                (c)           access to complete batches of cannabis products;

                                                (d)           determination of the number of sample increments required, based on batch size; and

                                                (e)           random selection of sample increments;

                                (2)           chain of custody;

                                (3)           data recording;

                                (4)           sample storage and integrity, including sealing of sample containers and, if applicable, the use of preservatives, inert gas, or other measures;

                                (5)           transportation, including protection from light, heat, and humidity;

                                (6)           sample preparation of each matrix for each test;

                                (7)           methodology for each test, including:

                                                (a)           sample preparation;

                                                (b)           reagent, solution, and reference standard preparation;

                                                (c)           instrument setup, as applicable;

                                                (d)           standardization of volumetric reagent solutions, as applicable;

                                                (e)           data acquisition; and

                                                (f)            calculation of results

                                (8)           data quality parameters for each test, including:

                                                (a)           specificity;

                                                (b)           limit of detection; and

                                                (c)           limit of quantitation;

                                (9)           reporting of results;

                                (10)         quality assurance;

                                (11)         employee policies and procedures, including but not limited to:

                                                (a)           adherence to state and federal laws that do not conflict with the Cannabis Regulation Act or the Lynn and Erin Compassionate Use Act;

                                                (b)           responding to an emergency, including robbery or a serious accident or incident;

                                                (c)           alcohol and drug-free workplace policies and procedures;

                                                (d)           safety and security procedures;

                                                (e)           occupational health and safety;

                                                (f)            crime prevention techniques; and

                                                (g)           if applicable, confidentiality laws, including the Health Insurance Portability and Accountability Act of 1996;

                                (12)         equipment cleaning, maintenance, and inspection standards and schedules;

                                (13)         standards for labeling, storage, expiration, and re-qualification dates and records relating to reagents, solutions, and reference standards;

                                (14)         sample analysis procedures, including but not limited to procedures for the use of only primary or secondary standards for quantitative analyses;

                                (15)         standards for data recording, review, storage, and reporting that include, but are not limited to, standards to ensure:

                                                (a)           that data is recorded in a manner consistent with this rule, and that it is reviewed to verify that applicable standards of practice, equipment calibration, and reference standards were applied before reporting;

                                                (b)           that all data, including raw data, documentation, protocols, and reports are retained in accordance with the requirements of this rule; and

                                                (c)           that reports are the property of the business or individual who provided the sample, and reports meet the requirements of this rule; and

                                (16)         creation of chain of custody documentation for each sample.

                B.            Training program:

                                (1)           Licensee shall implement a training program, approved by the division, to ensure that all personnel present at the premises are provided information and training that, at minimum, covers the following topics within 30 days of the start of employment:

                                                (a)           employee health and safety;

                                                (b)           health and safety hazards;

                                                (c)           hazard communication;

                                                (d)           security procedures; and

                                                (e)           record keeping/track and trace.

                                (2)           A cannabis testing laboratory must provide and document training on the following subjects before permitting any authorized person to independently collect samples of cannabis products:

                                                (a)           an overview of the process and standard operating procedures of the laboratory;

                                                (b)           quality control procedures, including sterile collection of samples and storage;

                                                (c)           chain of custody, recordkeeping, and tracking requirements;

                                                (d)           calibration, use, and maintenance of measuring devices;

                                                (e)           transportation procedures; and

                                                (f)            any additional information reasonably related to sample collection.

                                (3)           A cannabis testing laboratory must provide and document training on the following subjects before an agent or employee independently performs any cannabis testing process:

                                                (a)           an overview of the process and standard operating procedure(s);

                                                (b)           quality control procedures;

                                                (c)           chain of custody and tracking requirements;

                                                (d)           proper and safe usage of equipment or machinery;

                                                (e)           safe work practices applicable to an employee’s job tasks, including appropriate use of any necessary safety or sanitary equipment;

                                                (f)            cleaning and maintenance requirements;

                                                (g)           emergency operations, including shutdown; and

                                                (h)           any additional information reasonably related to an employee’s job duties.

                C.            Training documentation:

                                (1)           Licensee shall ensure that all personnel receive annual refresher training to cover, at minimum, the topics listed in this section. The licensee shall maintain a record which contains at minimum:

                                                (a)           a list of all personnel at the premises, including at minimum, name and job duties of each;

                                                (b)           documentation of training topics and dates of training completion for all personnel;

                                                (c)           dates of refresher training completion for all personnel; and

                                                (d)           the signature of each employee verifying receipt and understanding of each training or refresher training completed.

                                (2)           Licensee may assign responsibility for ensuring compliance by individual personnel with the requirements of this section to supervisory personnel.

                                (3)           Licensees shall maintain documentation of an employee’s training for a period of two years for current employees and at least six months after the termination of an employee’s employment.

                D.            Materials to be maintained on premises: A cannabis testing laboratory shall maintain on its premises, and shall promptly present to the department upon request:

                                (1)           all results of laboratory tests conducted on cannabis or cannabis derived products for a period of at least two years;

                                (2)           operating manuals and other documentation for each piece of equipment;

                                (3)           records of required inspection, calibration, and maintenance for each piece of equipment, including:

                                                (a)           the date of the operation;

                                                (b)           the person who performed it;

                                                (c)           the written procedure used; and

                                                (d)           any deviations from the written procedure;

                                (4)           records of non-routine repairs performed on equipment as a result of failure and malfunction, including:

                                                (a)           the nature of the repair;

                                                (b)           how and when the need for the repair was discovered; and

                                                (c)           any remedial action taken in response to the repair;

                                (5)           the certificate of analysis for all reference standards, whether acquired or internally produced.

                                (6)           current material safety data sheets for all chemicals used;

                                (7)           documentation of proficiency training.

[16.8.2.47 NMAC – N, 01/11/2022]

 

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.

[16.8.2.48 NMAC – N, 01/11/2022]

 

[16.8.2.43] 16.8.2.49          SEVERABILITY: If any part or application of this rule is held to be invalid, the remainder or its application to other situations or persons shall not be affected. Any section of this rule legally severed shall not interfere with the remaining protections and duties provided by this rule.

[16.8.2.49 NMAC – Rn, 16.8.2.43 NMAC, 01/11/2022]

 

History of 16.8.2 NMAC:  [RESERVED]