Req. No. 11004 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 STATE OF OKLAHOMA 2nd Session of the 58th Legislature (2022) COMMITTEE SUBSTITUTE FOR HOUSE BILL NO. 4056 By: Marti COMMITTEE SUBSTITUTE An Act relating to medical marijuana; amending 63 O.S. 2021, Section 427.17, w hich relates to the Oklahoma Medical Marijuana and Patient Protection Act; directing certain labo ratory to provide recommendations, standards and operating proce dures to the Oklahoma Medical Marijuana Authority; directing the Authority to promulgate rule s; requiring licensed medical marijuana testing laboratories to comply with rules; and declaring an emergency. BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHOMA: SECTION 1. AMENDATORY 63 O.S. 2021, Section 427.17, is amended to 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 Oklahoma Medical Marijuana Authority is hereby enabled to monitor, inspec t and audit a licensed testing laboratory under the Oklahoma Medical Marijuana and Patient Protection Act. Req. No. 11004 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 B. 1. The Authority is hereby authorized to contract with a private laboratory for the purpose of conducting complian ce testing of medical marijuana t esting laboratories licensed in this state. Any such laboratory under contract for compliance testing shall be prohibited from conducting any other commercial medical marijuana testing in this state. The laboratory the Au thority contracts with for compliance testing shall not employ, or be owned by, the following: 1. Any a. any individual that has a direct or indirect interest in a licensed medical marijuana business ;, or 2. Any b. any individual or his or her spouse, pa rent, child, spouse of a child, sibling or spouse of a sibling that has an application for a medical marijuana business license pending before the Department or is a member of the board of directors of a medical m arijuana business, or is an individual fina ncially interested in any licensee or medical marijuana business located within this state. 2. The private laboratory under contract with the Authority for compliance testing shall provide to the Authority its recommendations for brands and models of all equipment and standards to be utilized by licensed medical marijuana testing laboratories Req. No. 11004 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 when testing samples of medical marijuana, medical marijuana concentrate, and medical marijuana product s as well as standard operating procedures when extracting and testing medical marijuana, medical marijuana concentrate, and medical marijuana product s. The recommendations shall be submitted to the Authority no later than June 1, 2023. The Authority shall have ninety (90) days from the date it receives the recommendations to promulgate new rules or modify its current rules for laboratory standards and testing. Beginning June 1, 202 4, medical marijuana testing laboratories renewing their medical marijuana business license shall be subject to and comply with any new or modified rules relating to the testing of medical marijuana, medical marijuana concentrate , and medical marijuana products. C. The Authority shall develop acceptable testin g practices including, but not limited to, testing, standards, quality con trol analysis, equipment certificat ion and calibration, and chemical identification and substances used. D. A person who is a direct beneficial owne r of a medical marijuana dispensary, medical marijuana commer cial grower or medical marijuana processor sha ll not be an owner of a laboratory. E. A laboratory and a laboratory applicant sha ll comply with all applicable local ordinances including , but not limited to, zoning, occupancy, licensing and building codes. Req. No. 11004 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 F. A separate license shall be required for e ach specific laboratory. G. A medical marijuana testing laboratory license may b e issued to a person who performs testin g on medical marijuana and medical marijuana products for medical marijuana businesses, m edical marijuana research facilities, medical marijuana education facilities, and testing on marijuana and marijuana products g rown or produced by a patient or caregiver on behalf of a patient, upon verification of registration . A medical marijuana testin g laboratory may also conduct research related to the development and improvement of its testing practices and procedures. No state- approved medical marijuana testing facility shall operate unless a medical laboratory director is on site during operationa l hours. H. Laboratory applicants and license es 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 initial approval and periodic eva luations during the approval period . I. A medical marijuana testing laboratory may accept samples of medical marijuana, medical marijuana concentrate or medical marijuana product from a medical marijuana busin ess, medical marijuana research facility or me dical marijuana education facility for testing purposes only, which purposes may include the provision of testing services for samples submitted by a medical marijuana Req. No. 11004 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 business for product development . The Department may require a medical marijuana busine ss to submit a sample of medical ma rijuana, medical marijuana concentrate or medical marijuana product to a medical marijuana testing or quality assurance laboratory upon demand. J. A medical marijuana testing laboratory may accept samples of medical marijuana, medical marijuana concentrat e or medical marijuana product from an individual person for testing only under the following conditions: 1. The individual person is a patient or caregiver pursuant t o the Oklahoma Medical Marijuana and Patient Protecti on Act or is a participant in an ap proved clinical or observational study conducted by a research facility; and 2. The medical marijuana testing laboratory shall require the patient or caregiver to produce a v alid patient license and current and valid photo identification. K. A medical marijuana testing laboratory may transfer samples to another medical marijuana testing laboratory for testing . All laboratory reports provided to or by a medical marijuana busi ness or to a patient or caregiver shall identi fy the medical marijuana testing laboratory that actually conducted the test. L. A medical marijuana testing laboratory may utilize a licensed medical marijuana transporter to transport samples of medical marijuana, medical marijuana concentrate and medic al Req. No. 11004 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 marijuana product for testing, i n accordance with the Oklahoma Medical Marijuana and Patient Protection Act and the rules adopted pursuant thereto, between the originating medical marijuana business requesting testing services and the destination labora tory performing testing services. M. The medical marijuana testing laboratory shall establish policies to prevent the existence of or appearance of undue commercial, financial or other influences that may dimi nish the competency, impartiality and integrit y of the testing processes or results of the laboratory, or that may diminish public confidence in the competency, impartiality and integrity of the testing processes or results of the laboratory . At a minimum, employees, owners or agents of a medical mar ijuana testing laboratory who parti cipate in any aspect of the analysis and results of a sample are prohibited from improperly influencing the testing process, improperly manipulating data or improperly benefit ing from any ongoing financial, employment, pe rsonal or business relationship wit h the medical marijuana business that provided the sample. A medical marijuana testing laboratory shall not test samples for any medical marijuana business in which an owner, employee or agent of the medical marijuana te sting laboratory has any form of ow nership or financial interest in the medical marijuana business. Req. No. 11004 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 N. The Department, pursuant to rules promulgated by the State Commissioner of Health, shall develop standards , policies and procedures as necessary for: 1. The cleanliness and orderliness o f a laboratory premises and the location of the laboratory in a secure location, and inspection, cleaning and maintenance of any equipment or utensils used for the analysis of test samples; 2. Testing procedures, testing standards for cannabinoid and terpenoid potency and safe levels of contaminants, and remediation procedures; 3. Controlled access areas for storage of medical marijuana and medical marijuana product test samp les, waste and reference standards; 4. Records to be retained and computer syste ms to be utilized by the laboratory; 5. The possession, storage and use by the laboratory of reagents, solutions and reference standards; 6. A certificate of analysis (COA) for each lot of reference standard; 7. The transport and disposal of unused mari juana, marijuana products and waste; 8. The mandatory use by a laboratory of an inventory tracking system to ensure all harvest and production batches or samples containing medical marijuana, medical marijuana concentrat e or Req. No. 11004 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 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, destruction or disposal . The inventory tracking system reporting shal l include the results of any tests that are conducted on medical marijuana, medical marijuana concentrate or medical marijuana product; 9. Standards of performance; 10. The employment of laboratory personnel; 11. A written standard operating procedure m anual to be maintained and updated by the laboratory; 12. The successful participation in a Department -approved proficiency testing program for each testing category 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 immediate recall of medical marijuana o r medical marijuana products that test above a llowable thresholds or are otherwise determined to be unsafe; 15. The establishment by the laboratory of a system to document the complete chain of custody for samples from receipt through disposal; 16. The establishment by the laboratory of a system to retain and maintain all required re cords, including business records, and Req. No. 11004 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 processes to ensure results are reported in a timely and accurate manner; and 17. Any other aspect of laboratory testing of medical mar ijuana or medical marijuana product deemed nec essary by the Department. O. A medical marijuana testing laboratory shall promptly provide the Department or designee of the Department access to a report of a test and any underlying data that is conducted on a sample at the request of a medical marijuan a business or qualified patient. A medical marijuana testing laboratory shall also provide access to the Department or designee of the Department to laboratory premises and to any material or information reque sted by the Department to determine compliance with the requirements of this section. P. A medical marijuana testing laboratory shall retain all results of laboratory tests conducted on marijuana or products for a period of at least seven (7) years and shall make them available to the Department upon request. Q. A medical marijuana t esting laboratory shall test samples from each harvest batch or product batch, as appropriate, of medical marijuana, medical marijuana concentrate and medical marijuana product for each of the following categories of test ing, consistent with standards developed by the Commissioner: 1. Microbials; 2. Mycotoxins; Req. No. 11004 Page 10 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. Residual solvents; 4. Pesticides; 5. Tetrahydrocannabinol (THC) and other cannabinoid potency; 6. Terpenoid type and concentration ; and 7. Heavy metals. R. A licensed medical marijuana testing laboratory shall test each individual harvest batch . A grower shall separate each harvest lot of usable marijuana into harvest batches containing no more tha n fifteen (15) pounds, with the exception of any plant mat erial to be sold to a licensed proc essor for the purposes of turning the plant material into concentrate which may be separated into harvest batches of no more than fifty (50) pounds . A processor shall separate each medical marijuana production lot into p roduction batches containing no mor e than four (4) liters of concentrate or nine (9) pounds for nonliquid products, and for final products, the Oklahoma Medical Marijuana Authority shall be authorized to promulgate rules on final products as necessary . Provided, however, the Authority shall not require testing of final products less often than every one thousand (1,000) grams of THC. As used in this subsection, "final products" shall include, but not be limite d to, cookies, brownies, candies, gummies, bev erages and chocolates . S. Medical marijuana testing laboratory licensure shall be contingent upon successful on -site inspection, successful Req. No. 11004 Page 11 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. A medical marijuana testing laborato ry shall be inspected prior to initial licensure an d up to two (2) times per year thereafter by an inspector approved by the Authority . The Authority may enter the licensed p remises of a testing laboratory to conduct investigations and additional inspecti ons when the Authority believes an investigation or additional inspection is necessary due to a possible violation of applicable laws, rules or regulations. U. Medical marijuana testing laboratories shall obtain accreditation by an accrediting body approv ed by the Commissioner within one (1) year of the date the initial license is issued . Renewal of any medical marijuana testing laboratory license shall be contingent upon accreditation in accordance with this subsection . All medical marijuana testing lab oratories shall obtain accreditation prior to applying for and receiving a medical marijuana testing laboratory license . V. Unless authorized by the provisions of this sectio n, a commercial grower shall not transfer or s ell medical marijuana and a processor shall not transfer, sell or process into a concentrate or product any medical marijuana, medical marijuana concentrate or medical marijuana product unless samples from each harvest batch or production batch from which that medical marijuana, medical marijuana concentrate or medical marijuana product was derived has Req. No. 11004 Page 12 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 been tested by a medical marijuana testin g laboratory and passed all contaminant tests required b y the Oklahoma Medical Marijuana and Patient Protection Act and applicable laws, rules and regu lations. A licensed commercial grower may transfer medical marijuana that has failed testing to a licensed processor only for the purposes of decontamination or remediation a nd only in accordance with the provisions of the Oklahoma Medical Marijuana and P atient Protection Act and the rules and regulations of the Department . Remediated and decontaminated medical marijuana may be returned only to the originating licensed commer cial grower. W. Kief shall not be transferred or sold except as authorized in the rules and regulations of the Department. SECTION 2. It being immediately necessary for the preservation of the public peace, health or safety, an emergency is hereby declared to exist, by reason whereof this act shall take effect and be in full force from and after its passage an d approval. 58-2-11004 JL 03/03/22