Req. No. 9910 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) HOUSE BILL 4416 By: Lowe (Dick) AS INTRODUCED An Act relating to medical marijuana; amend ing 63 O.S. 2021, Section 427.17, which relates to the Oklahoma Medical Marijuana and Pat ient Protection Act; directing licensed medical marijuana growers to annually submit certain information to the Oklahoma Medical Marijuana Authority; and providing an effective date. BE IT ENACTED BY THE PEOPL E 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 li cense 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. B. The Authority is hereby authorized to contract with a private laboratory for the purpose of conducting compliance te sting of medical marijuana t esting laboratories licensed in this state . Req. No. 9910 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 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 Authori ty contracts with for compliance testing shall not employ, or be owned by, the following: 1. Any individual that has a direct or indirect inter est in a licensed medical marijuana business; or 2. Any individual or his or her spouse, parent, child, spouse of a child, sibling or spo use 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 marijuana business, o r is an individual financially interested i n any licensee or medical marijuana business located within this state. C. The Authority shall develop acceptable testin g practices including, but not limited to, testing, standards, quality control analysis, equipment certification and calibration, and c hemical identification and substances used. D. A person who is a direct beneficial owne r of a medical marijuana dispensary, medical marijuana c ommercial grower or medical marijuana processor shall not be an owner of a laboratory. E. A laboratory and a l aboratory applicant sha ll comply with all applicable local ordinances including , but not limited to, zoning, occupancy, licensing and building co des. Req. No. 9910 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 F. A separate license shall be required for each specific laboratory. G. A medical marijuana testing lab oratory license may b e issued to a person who performs testin g on medical marijuana and medical marijuana products for medical marijuana business es, medical marijuana research facilities, medical marijuana educatio n facilities, and testin g 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 t esting laboratory may also conduct research related to the developmen t 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 opera tional hours. H. Laboratory applicants and licensees shall comply with the application requirements of this se ction and shall submit such other information as required for a medical marijuana business applicant, in addition to any information the Authorit y may request for initial approval and periodic evaluations during th e 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 business, medical marijuana research facility or medical marijuana ed ucation facility for testing purposes only, which purposes may include the provision of testing services for samples submitted by a medical marijuana Req. No. 9910 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 business for product development . The Department may require a medical marijuana business to submit a sam ple of medical marijuana, medical marijuana concentrate or medical marijuana product to a medical marijuana testing or quality assurance laboratory upon demand. J. A medical marijuana te sting laboratory may accept samples of medical marijuana, medical mar ijuana concentrate 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 Protection Act or is a participant in an approved clinical or observ ational study conducted by a research facility; and 2. The medical marijuana testing laboratory shall require the patient or caregiver to produc e a valid patient license and current and valid photo identification. K. A medical marijuana testing laborator y may transfer samples to another medical marijuana testing laboratory for testing . All laboratory reports provided to or by a medical marijuana business or to a patient or caregiver shall identify the medical mar ijuana testing laboratory that actually co nducted 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 medical Req. No. 9910 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 marijuana product for testing, in accordance wit h 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 laboratory 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 diminish the competency, impartiality and integrity of the testing p rocesses 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 marijuana testing lab oratory who participate in any aspect of the analysis and results of a sample are prohibited from improperly influencing the testing process, improperly manipulating data or improperly be nefiting from any ongoing financial, employment, personal or business relationship with 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 o wner, employee or agent of the medical marijuana testing laboratory h as any form of ownership or financial interest in the medical marijuana business. Req. No. 9910 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 N. The Department, pursuant to rules promulgated by the State Commissioner of Health, shall develop stan dards, policies and procedures as necessary for: 1. The cleanliness and orderliness of a laboratory premises a nd 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 can nabinoid and terpenoid potency and safe le vels of contaminants, and remediation procedures; 3. Controlled access areas for storage of medical marijuana and medical marijuana product test samples, waste and reference standards; 4. Records to be retained a nd computer systems 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 dispos al of unused marijuana, 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 concentrate or Req. No. 9910 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 medical marijuana products are identified and tracked f rom the point they are transferred from a medical marijuana business, a patient or a caregiver through the point of transfer, destruction or disp osal. The inventory tracking system reporting shall include the resu lts of any tests that are conducted on med ical marijuana, medical marijuana concentrate or medical marijuana product; 9. Standards of performance; 10. The employment of laboratory perso nnel; 11. A written standard operating procedure manual 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 ob tain and maintain certification; 13. The establishment of and adhere nce 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 mariju ana or medical marijuana products that test above allowable threshold s or are otherwise determined to be unsa fe; 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 records , including business records, and Req. No. 9910 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 processes to ensure results are reported in a timely and accurate manner; and 17. Any other aspect of laboratory testing of medica l marijuana or medical marijuana product deemed necessary by the Depa rtment. O. A medical marijuana test ing laboratory shall promptly provide the Department or designee of the Department access to a report of a test and any underlying data that is conduct ed on a sample at the request of a medical marijuana business or qual ified 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 requested by the Department to determine compliance with the requirem ents 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 testing 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 testing, consistent with standards developed by the Comm issioner: 1. Microbials; 2. Mycotoxins; Req. No. 9910 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 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 material to be sold to a licensed processor 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 production batches containing no more tha n 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 req uire 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 l imited to, cookies, brownies, candies, gummies, beverages and chocola tes. S. Medical marijuana testing laboratory licensure shall be contingent upon successful on -site inspection, successful Req. No. 9910 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 participation in proficiency testing and ongoing compliance with the applicable requirements in this section. T. A medical marijuana testing laboratory shal l 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 premises of a testing laboratory to conduct investigations and ad ditional inspections whe n 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 approved 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 laborator ies shall obtain accreditation prior to applying for and receiving a medical marijuana testing laboratory license . V. Unless authorized by the provisions of this s ection, a commercial grower shall not transfer or sell medical mariju ana and a processor shall not transfer, se ll 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 marij uana, medical marijuana concentrate or med ical marijuana product was derived has Req. No. 9910 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 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 law s, rules and regulatio ns. A licensed commercial grower may transfer medical marijuana that has failed testing to a licensed processor only for the purposes of decontamination or remediat ion and only in accordance with the provisions of the Oklahoma Medica l Marijuana and Patien t Protection Act and the rules and regulations of the Department . Remediated and decontaminated medical marijuana may be returned only to the originating licensed c ommercial grower. W. Beginning November 1, 2022, a licensed medical marijuana commercial grower shall submit annually to the Authority the business name, business address, and business license identification number of every licensed medical marijuana testing laboratory that the commercial grower contracts with to conduct contamination tests on samples of its harvest batches. Licensed medical marijuana commercial growers shall be required to notify the Authority within ten (10) days of utilizing the services of a different licensed medical marijuana testing laboratory. X. Kief shall not be transferred or sold except as authorized in the rules and regulations o f the Department. SECTION 2. This act shall become effective November 1, 2022. 58-2-9910 GRS 01/04/22