Req. No. 928 Page 1 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 STATE OF OKLAHOMA 1st Session of the 58th Legislature (2021) SENATE BILL 174 By: Rader AS INTRODUCED An Act relating to medical marijuana; amend ing Section 17, Chapter 11, O.S.L. 2019, as amended by Section 4, Chapter 312, O.S.L. 2019 (63 O.S. Supp. 2020, Section 427.17) , which relates to m edical marijuana testing laboratory license ; providing qualifications for medical laboratory director; clarifying language; and providing an effective da te. BE IT ENACTED BY THE PEOPLE O F THE STATE OF OKLAHOMA: SECTION 1. AMENDATORY Section 17, Chapter 11, O.S.L. 2019, as amended by Section 4, Chapter 312, O.S.L. 2019 (63 O.S. Supp. 2020, Section 427.17), is amended t o read as follows: Section 427.17. A. There is hereby created a medical marijuana testing laboratory license as a category of the medical marijuana business license. The Authority is hereby enabled to monitor, inspect and audit a licensed testing labora tory under this act. B. The Authority is hereby au thorized to contract with a private laboratory for the purpose of conducting compliance testing of medical marijuana testing laboratories licensed in this state. Any such laboratory under contract for com pliance testing shall be Req. No. 928 Page 2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 prohibited from conducting any other commercial medical marijuana testing in this state. C. The Authority shall have the authority to develop acceptable testing and research practices , including but not limited to testing, standards, quality control analysis, equipment certification and calibration, and chemical identification and substances used in bona fide research methods so long as it complies with this act. D. A person who is a direct b eneficial owner or an indirect beneficial owner of a medical marijuana dispensary, medical marijuana commercial grower, or medical marijuana processor shall not be an owner of a laboratory. E. A laboratory and a or laboratory applicant shall comply with all applicable local ordinances, includi ng but not limited to zoning, occupancy, licensing and building codes. F. A separate license shall be required for each specific laboratory. G. A medical marijuana testing laboratory license may be issued to a person who performs testing and research on medical marijuana and medical marijuana products fo r medical marijuana businesses, medical marijuana research facilities, medical marijuana education facilities, and testing and research on marijuana and marijuana products grown or produced by a patient or caregiver on behalf of a patient, upon verificatio n of registration. Req. No. 928 Page 3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 H. No state-approved medical marijuana testing facility shall operate unless a medical laboratory director is on site during operational hours. A medical laboratory director must posse ss a bachelor’s degree in the chemical, environment al, biological or physical sciences or engineering, with at least a total of twenty- four (24) college semester credit hours in chemistry or biology and at least two (2) years of experience in the environme ntal analysis of representative inorganic and organ ic analytes for which the laboratory will be performing . A master’s degree or doctoral degree in one of the above disciplines may be substituted for one (1) year of experience. H. I. A laboratory applicant shall comply with the application requirements of this section and shall submit such other information as required for a medical marijuana business applicant, in addition to any information the Authority may request for initi al approval and periodic evaluations during the approval period. I. J. A medical marijuana testing laboratory may accept samples of medical marijuana, medical marijuana concentrate or medical marijuana product from a medical marijuana business for testing and research purposes only, which purposes may include the provision of testing services for samples submitted by a medic al marijuana business for product development. The Department may require a medical marijuana business to submit a sample of medical marijuana, Req. No. 928 Page 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 medical marijuana concentrate or medical marijuana product to a medical marijuana testing laboratory upon deman d. J. K. A medical marijuana testing laboratory may accept samples of medical marijuana, medical marijuana concentrate or medical marijuana product from an individual person for testing only under the following conditions: 1. The individual person is a p atient or caregiver pursuant to this act or is a participant in an approved clinical or observational study conducted by a research fa cility; and 2. The medical marijuana testing laboratory shall require the patient or caregiver to produce a valid patient license and current and valid photo identification. K. L. A medical marijuana testing laboratory may transfer samples to another med ical marijuana testin g laboratory for testing. All laboratory reports provided to or by a medical marijuana business or to a patient or caregiver shall identify the medical marijuana testing laboratory that actually conducted the test. L. M. A medical marijuana testing laborato ry may utilize a licensed medical marijuana transporter to transport samples of medical marijuana, medical marijuana concentrate and medical marijuana product for testing, in accordance with this act and the rules adopted pursuant t hereto, between the orig inating medical marijuana business requesting testing s ervices and the destination laboratory performing testing services. Req. No. 928 Page 5 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 M. N. The medical marijuana testing laboratory shall establish policies to prevent the existence of or appea rance of undue commercial, financial or other influences that may diminish the competency, impartiality and integrity of t he testing processes or results of the laboratory, or that may diminish public confidence in the competency, impartiality and integrit y of the testing processes or results of the laboratory. At a minimum, employe es, owners or agents of a medical marijuana testing laboratory who participate in any aspect of the analysis and results of a sample are prohibited from improperly influencing t he testing process, imprope rly manipulating data, or improperly benefiting from any ongoing financial, employment, persona l or business relationship with the medical marijuana business that provided the sample. N. O. The Department, pursuant to rules prom ulgated by the State Commissioner of Health, shall develop standards, policies and procedures as necessary for: 1. The cleanliness and orderliness of a laboratory premises and the location of the laboratory in a secure location, and inspection, cleaning and maintenance of any equipm ent or utensils used for the analysis of test sampl es; 2. Testing procedures, testing standar ds for cannabinoid and terpenoid potency and safe levels of contaminants, and remediation procedures; Req. No. 928 Page 6 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 3. Controlled access areas for storage of medical marijuana and medical marijuana product test samples, waste and reference standards; 4. Records to be retained and computer systems to be utilized by the laboratory; 5. The possession, storage and use by the laboratory of reagents, solutions and reference standar ds; 6. A certificate of analysis (COA) for each lo t of reference standard; 7. The transport and disposal of unused marijuana, marijuana products and waste; 8. The mandatory use by a laboratory of an inventory tracking system to ensure all test batches o r samples containing medical marijuana, medical mar ijuana concentrate or medical marijuana products are identified and tracked from the point they are transferred from a medical marijuana business, a patient or a caregiver through the point of transfer, de struction or disposal. The inventory tracking syst em reporting shall include the results of any tests that are conducted on medical marijuana, medical marijuana concentrate or medical marijuana product; 9. Standards of perform ance; 10. The employment of laboratory personnel; 11. A written standard oper ating procedure manual to be maintained and updated by the laboratory; Req. No. 928 Page 7 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 12. The successful participation in a Department -approved proficiency testing program for each testing ca tegory listed in this section, in order to obtain and maintain certification; 13. The establishment of and adherence to a quality assurance and quality control program to ensure sufficient monitoring of laboratory processes and quality of results reported ; 14. The establishment by the laboratory of a system to document the complete chain of custody for samples from receipt through disposal; 15. The establishment by the laboratory of a system to retain and maintain all required records, including business records, and processes to ensure results are reported in a timely and accurate manner; and 16. Any other aspect of labor atory testing of medical marijuana or medical marijuana product deemed necessary by the Department. O. P. A medical marijuana testing laboratory shall promptly provide the Department or designee of the Department access to a report of a test and any under lying data that is conducted on a sample at the request of a medical marijuana business or qualified patient. A medical marijuana tes ting laboratory shall also p rovide access to the Department or designee of the Department to laboratory premises and to any material or information requested by the Department to determine compliance with the requirements of this section. Req. No. 928 Page 8 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 P. Q. A medical marijuana testing laboratory shall retain all results of laboratory tests condu cted on marijuana or products for a period of at least two (2) years and shall make them available to the Department upon request. Q. R. A medical marijuana testing laboratory shall test samples from each harvest batch or product batch, as appropriate, of medical marijuana, medical marijuana conce ntrate and medical marijuana product for each of the following categories of testing, consistent with standards developed by the Commi ssioner: 1. Microbials; 2. Mycotoxins; 3. Residual solvents; 4. Pesticides; 5. Tetrahydrocannabinol (THC) and other c annabinoid potency; 6. Terpenoid potency; and 7. Heavy metals. R. S. A test batch shall not exceed ten (10) pounds of usable marijuana or medical marijuana pro duct, as appropriate. A grower shall separate each harvest lot of usable marijuana into harve st batches containing no more than ten (10) pounds. A processor shall separate each medical marijuana production lot into production batches containing no more t han ten (10) pounds. S. T. Medical marijuana testi ng laboratory licensure shall be contingent upon successful on-site inspection, successful Req. No. 928 Page 9 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 participation in proficiency testing and ongoing compliance with the applicable requirements in this section. T. U. A medical marijuana testing laboratory shall be inspected prior to initial licensure and an nually thereafter by an inspector approved by the Authority. U. V. Beginning on a date determined by the Commissioner, not later than January 1, 2020, medical ma rijuana testing laborat ory licensure shall be conti ngent upon accreditation by the NELAC Institute (TNI), ANSI/ASQ National Accreditation Board or another accrediting body approved by the Commissioner, and any applicable standards as determined by the Depa rtment. V. W. A commercial grower shall not transf er or sell medical marijuana and a processo r shall not transfer, sell or process into a concentrate or product any medical marijuana, medical marijuana concentrate or medical ma rijuana product unless sampl es from each harvest batch or production batch from which that medical marijuana, medical marijuana concentrate or medical marijuana product was derived has been tested by a medical marijuana testing facility for contaminants and passed all contaminant tes ts required by this act. SECTION 2. This act shall become effective November 1, 2021. 58-1-928 DC 12/22/2020 11:13:00 AM