N.M. Admin. Code § 7.34.4.17

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

Section 7.34.4.17 - DEPARTMENT-APPROVED TESTING LABORATORIES; GENERAL PROVISIONS

A laboratory applicant shall comply with the application requirements of this rule, and shall submit such other information as the laboratory applicant wishes to provide or such information as the department may request for initial approval and periodic evaluations during the approval period.

A.Testing categories: A laboratory may apply to become approved by the department as an approved laboratory for the testing of cannabis and cannabis derived products in all or any one of the following categories:

(1) mycotoxin analysis;

(2) microbiological contaminant analysis;

(3) solvent residue analysis;

(4) quantity of THC and CBD; and

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

B.Fee: A laboratory applicant shall submit to the program with each initial application and renewal application for continued approval a non-refundable application fee of two-thousand-two-hundred dollars ($2,200), payable to the medical cannabis program.

C.Application materials: A laboratory applicant shall submit to the program with each initial application and renewal application for continued approval the following:

(1) standard operating procedures to be followed by the laboratory, including but not limited to policies and procedures to be used in performing analysis of samples;

(2) a description of the type of tests to be conducted by the laboratory applicant, which may include, but are not limited to, testing for microbiological contaminants, mycotoxins, solvent residue, THC content, CBD content, identity, purity, strength, composition, or nutritional content, and other quality factors;

(3) quality control criteria for the test(s) that the applicant intends to conduct;

(4) evidence that validates the accuracy of the test(s) to be conducted by the laboratory applicant as performed in the applicant's laboratory;

(5) proof that the laboratory applicant is in good standing with the New Mexico taxation and revenue department;

(6) copies of the laboratory applicant articles of incorporation and by-laws, as applicable;

(7) a list of all persons or business entities having direct or indirect authority over the management or policies of the laboratory applicant;

(8) a list of all persons or business entities having any ownership interest in any property utilized by the laboratory applicant, whether direct or indirect, and whether the interest is in land, building(s), or other material, including owners of any business entity that owns all or part of land or building(s) utilized;

(9) a description of the facilities and equipment that shall be used in the operation of the laboratory applicant;

(10) a description of how the laboratory applicant will ensure and document chain of custody of any samples held or tested by the laboratory;

(11) a general written security policy, to address at a minimum safety and security procedures;

(12) an attestation that no firearms will be permitted on any premises used by the laboratory applicant;

(13) a description of the methods and device or series of devices that shall be used to provide security;

(14) training documentation prepared for each employee of the laboratory applicant, statements signed by employees indicating the topics discussed (to include names and titles of presenters) and the date, time, and place the employee received said training;

(15) personnel records for each employee of the laboratory applicant that include an application for employment and a record of any disciplinary action taken;

(16) employee safety and security training materials provided to each employee of the laboratory applicant at the time of his or her initial appointment, to include training in the proper use of security measures and controls that have been adopted, and specific procedural instructions regarding how to respond to an emergency, including robbery or a violent accident;

(17) documented proof of required initial and continuing demonstrations of capability, in accordance with this rule;

(18) proof that no buildings to be used by the applicant are located within 300 feet of any school, church, or daycare center; or alternatively, proof that any school, church, or daycare center that is located within 300 feet of a building to be used by the applicant did not occupy that location prior to the applicant initially seeking to become licensed to operate at the location;

(19) an attestation that the laboratory will not operate in any location within 300 feet of a school, church or daycare center; and

(20) such other materials as the department may require.

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

(1) personnel documentation including, but not limited to employment records, job descriptions, education, and training requirements of the laboratory, and documentation of education and training provided to staff for the purpose of performance of assigned functions;

(2) requirements concerning laboratory operations, business licensing, and security procedures;

(3) standards for receipt, handling, and disposition of samples of usable cannabis;

(4) equipment information detailing the type of equipment used, inspection standards and practices, testing and calibration schedules and records, and standards for cleaning and maintenance of equipment;

(5) reagents, solutions, and reference standards including, but not limited to standards for labeling, storage, expiration, and re-qualification dates and records;

(6) reference standards, acquired or internally produced, including the certificate of analysis;

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

(8) documentation demonstrating that the analytical methods used by the laboratory are appropriate for their intended purpose; that staff is proficient in the process; and that deviations from approved standards of practice do not occur without proper authorization;

(9) 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.

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

(11) such other materials as the department may require.

E.Proficiency testing and inspection:

(1) A laboratory applicant shall be subject to proficiency testing by the department or its designee prior to approval, and an approved laboratory shall be subject to proficiency testing, at a frequency and at times to be determined by the program director or designee. A laboratory applicant or approved laboratory shall cooperate with the department or its designee for purposes of conducting proficiency testing. The department or its designee may require submission of cannabis and cannabis-derived product samples from licensed non-profit producers and approved manufacturers for purposes of proficiency testing.

(2) A laboratory applicant and an approved laboratory shall be subject to inspection(s), at times determined by the program director or designee, in accordance with the provisions of this rule. The department may require the inspection of premises, equipment, and written materials to determine compliance with this rule, and to determine compliance with the application submissions of the laboratory applicant or approved laboratory, including but not limited to standard operating procedures and standards for testing.

(3) Failure of proficiency testing: If the department determines on the basis of a proficiency test that a laboratory applicant has not satisfactorily identified the presence, quantity, or other relevant factor(s) pertaining to a given analyte, the department may deny the application in whole or in part, require additional tests, or require remedial actions to be taken by the laboratory applicant. If the department determines on the basis of a proficiency test that an approved laboratory has not satisfactorily identified the presence, quantity, or other relevant factor(s) pertaining to a given analyte, the department may withdraw approval of the laboratory in whole or in part, require additional tests, or require remedial actions to be taken by the approved laboratory.

F.Retention and inspection of testing records: An approved laboratory shall retain all results of laboratory tests conducted on cannabis or cannabis derived products for a period of at least two years and shall make them available to the program upon the program's request.

G.Identification cards: An employee of an approved laboratory shall carry their department issued employee identification card at all times during their work, and shall present the card to law enforcement officials and to department officials upon request. An employee who is unable to produce their department issued identification card upon request shall not remain on the licensed premises, and shall produce the card for the department's inspection prior to returning to the licensed premises. Identification cards issued by the department are the property of the department and shall be returned to the department upon the termination of the holder's employment with the approved laboratory, upon suspension, or revocation, or upon demand of the department.

H.Reporting of theft to department: A laboratory shall submit to the department notification of any theft, robbery, break-in, or security breach that occurs on the laboratory's premises, no later than 10 calendar days after the laboratory first becomes aware of the event. The description shall include a description of any property that was stolen or destroyed, and the quantity of any usable cannabis that was stolen.

I. Term of approval: Department approval of a laboratory for purposes of this rule shall be for a term of one year, and shall expire after that year, or upon closure of the approved laboratory. An approved laboratory shall apply for renewal of approval annually no later than 60 days prior to expiration.

J.Amended license:

(1) An approved laboratory shall submit to the department an application form for an amended license, and shall obtain approval from the department, at least 30 business days prior to implementing any:

(a) change of location of the laboratory's facilities, change of directors, change of ownership of the laboratory's facilities, change of company name, and any physical modification or addition to the laboratory's facilities; and

(b) substantial change to the laboratory's standard operating procedures or substantial change to the types of tests to be conducted.

(2)Process for incomplete application for amended license: In the event that an application for amended licensure is determined by the program to be incomplete, the program will specify the information or materials that remain to be submitted. If the laboratory does not submit the requested information or material, and does not otherwise contact the department regarding the application, within thirty days of receiving notice of the deficiency, the application will be closed as incomplete, and the laboratory will be required to resubmit the application in order to recommence the application process.

K.Termination: The department may deny, withdraw, or suspend approval of a laboratory in accordance with this rule, upon determination by the department that the laboratory has violated a provision of this rule, upon failure of a proficiency test, upon the refusal of the laboratory to provide requested access to premises or materials, or upon the failure of a laboratory to comply with any standard, procedure, or protocol developed, submitted, or maintained pursuant to this rule.

N.M. Admin. Code § 7.34.4.17

7.34.4.17 NMAC - Rp, 7.34.4.15 NMAC, 12/30/2010, Amended by New Mexico Register, Volume XXVI, Issue 04, February 27, 2015, eff. 2/27/2015, Amended by New Mexico Register, Volume XXVII, Issue 04, February 29, 2016, eff. 2/29/2016, Adopted by New Mexico Register, Volume XXXI, Issue 12, June 23, 2020, eff. 6/23/2020