Oklahoma 2022 Regular Session

Oklahoma Senate Bill SB1847 Compare Versions

Only one version of the bill is available at this time.
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5353 STATE OF OKLAHOMA
5454
5555 2nd Session of the 58th Legislature (2022)
5656
5757 SENATE BILL 1847 By: Rogers
5858
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6363 AS INTRODUCED
6464
6565 An Act relating to medical marijuana; amending 63
6666 O.S. 2021, Section 427.17, which rel ates to medical
6767 marijuana testing laboratory license; allowing
6868 process validation as an acceptable testing practi ce;
6969 requiring process validation not to be mandatory by a
7070 licensee; allowing for mi nimum testing once a
7171 licensee achieves process v alidation; providing
7272 retention policies for the validation process;
7373 providing conditions to be maintained if significant
7474 process changes are made by licensee; allowing for
7575 inspection or audit by Authority; providing
7676 punishment for violation; accessing a registration
7777 fee; allowing for no law, rule , or regulation to
7878 prohibit testing labs for offering services to
7979 licensees; providing for samples consistent with
8080 process validation rules; declaring an emergency.
8181
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8585 BE IT ENACTED BY THE PEOPLE OF THE STATE OF OKLAHO MA:
8686 SECTION 1. AMENDATORY 63 O.S. 2021, Section 427.17, is
8787 amended to read as follows:
8888 Section 427.17. A. There is hereby created a medical marijuana
8989 testing laboratory license as a category of the medical marijuana
9090 business license. The Oklahoma Medical Marijuana Authority is
9191 hereby enabled to monitor, inspec t and audit a licensed testing
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143143 laboratory under the Oklahoma Medical Marijuana and Patient
144144 Protection Act.
145145 B. The Authority is hereby authorized to contract with a
146146 private laboratory for the purpose of conducting complian ce testing
147147 of medical marijuana t esting laboratories licensed in this state .
148148 Any such laboratory under contract for compliance testing shall be
149149 prohibited from conducting any other commercial medical marij uana
150150 testing in this state . The laboratory the Au thority contracts with
151151 for compliance testing shall not employ, or be owned by, the
152152 following:
153153 1. Any individual that has a direct or indirect interest in a
154154 licensed medical marijuana business; or
155155 2. Any individual or his or her spouse, parent, child, sp ouse
156156 of a child, sibling or spo use of a sibling that has an application
157157 for a medical marijuana business license pending before the
158158 Department or is a member of the board of directors of a medical
159159 marijuana business, or is an individual financially interes ted in
160160 any licensee or medical marijuana business located within this
161161 state.
162162 C. The Authority shall develop acceptable testin g practices
163163 including, but not limited to, testing, standards, quality control
164164 analysis, equipment certification and calibration, process
165165 validation, and chemical identification an d substances used.
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217217 D. A person who is a direct beneficial owner of a medical
218218 marijuana dispensary, medical marijuana commercial grower or medical
219219 marijuana processor shall not be an owner of a laboratory.
220220 E. A laboratory and a l aboratory applicant sha ll comply with
221221 all applicable local or dinances including, but not limited to,
222222 zoning, occupancy, licensing and building codes.
223223 F. A separate license shall be required for each specific
224224 laboratory.
225225 G. A medical marijuana testing lab oratory license may b e issued
226226 to a person who performs testin g on medical marijuana and medical
227227 marijuana products for medical marijuana businesses, medical
228228 marijuana research facili ties, medical marijuana education
229229 facilities, and testing on marijuana and marijuana products g rown or
230230 produced by a patient or caregiv er on behalf of a patient, upon
231231 verification of registration . A medical marijuana testing
232232 laboratory may also conduct re search related to the development and
233233 improvement of its testing practices and procedures. No state-
234234 approved medical marijuana testing facility shall operate unless a
235235 medical laboratory director is on site during operational hours.
236236 H. Laboratory applicants and licensees shall comply with the
237237 application requirements of this se ction and shall submit such other
238238 information as required for a medical marijuana business applicant,
239239 in addition to any information the Authority may request for initial
240240 approval and periodic evaluations during the approval period.
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292292 I. A medical marijuana testing laboratory may accept samples of
293293 medical marijuana, medical marijuana concentrate or medical
294294 marijuana product from a medical marijuana business , medical
295295 marijuana research facility or medical marijuana education facility
296296 for testing purposes only, which purposes may include the provision
297297 of testing services for samples submitted by a medical marijuana
298298 business for product development . The Department may require a
299299 medical marijuana business to submit a sample of medical mar ijuana,
300300 medical marijuana concentrate or medical marijuana product to a
301301 medical marijuana testing or quality assurance laboratory upon
302302 demand.
303303 J. A medical marijuana testing laboratory may accept samples o f
304304 medical marijuana, medical marijuana concentrate or medical
305305 marijuana product from an individual person for testing only under
306306 the following conditions:
307307 1. The individual person is a patient or caregiver pursuant t o
308308 the Oklahoma Medical Marijuana and Pa tient Protection Act or is a
309309 participant in an app roved clinical or observ ational study conducted
310310 by a research facility; and
311311 2. The medical marijuana testing laboratory shall require the
312312 patient or caregiver to produce a valid patient license and current
313313 and valid photo identification.
314314 K. A medical marijuana testing laborator y may transfer samples
315315 to another medical marijuana testing l aboratory for testing. All
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367367 laboratory reports provided to or by a medical marijuana business or
368368 to a patient or caregive r shall identify the medical marijuana
369369 testing laboratory that actually co nducted the test.
370370 L. A medical marijuana testing laboratory may utilize a
371371 licensed medical marijuana transporter to transport samples of
372372 medical marijuana, medical marijuana concent rate and medical
373373 marijuana product for testing, in accordance with the Oklahoma
374374 Medical Marijuana and Patient Protection Act and the rules adopted
375375 pursuant thereto, between the originating medical marijuana business
376376 requesting testing services and the dest ination laboratory
377377 performing testing services.
378378 M. The medical marijuana testing laboratory shall establish
379379 policies to prevent the ex istence of or appearance of undue
380380 commercial, financial or other influences that may diminish the
381381 competency, impartialit y and integrity of the testing processes or
382382 results of the laboratory, or that may diminish public confidence in
383383 the competency, impart iality and integrity of the testing processes
384384 or results of the laboratory . At a minimum, employees, owners or
385385 agents of a medical marijuana testing laboratory who partic ipate in
386386 any aspect of the analysis and results of a sample are prohibited
387387 from improperly influencing the testing process, improperly
388388 manipulating data or improperly benefiting from any ongoing
389389 financial, employment, personal or business relationship with the
390390 medical marijuana business that provided the sample. A medical
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442442 marijuana testing laboratory shall not test samples for any medical
443443 marijuana business in which an owner, employee or agent of the
444444 medical marijuana testing laboratory has any form of own ership or
445445 financial interest in the medical marijuana business.
446446 N. The Department, pursuant to rules promulgated by the State
447447 Commissioner of Health, shall develop standards, policies and
448448 procedures as necessary for:
449449 1. The cleanliness and orderliness of a laboratory premises a nd
450450 the location of the laboratory in a secure location, and i nspection,
451451 cleaning and maintenance of any equipment or utensils used for the
452452 analysis of test samples;
453453 2. Testing procedures, testing standards for cannabinoid and
454454 terpenoid potency and safe le vels of contaminants, process
455455 validation, and remediation procedures. Process validation shall be
456456 voluntary, and no licensee shall be required to validate their
457457 process. The Department shall develop standards and requirements
458458 for a licensee to achieve process validation. The standards,
459459 policies, and procedures for process validation shall include, but
460460 not be limited to:
461461 a. initial requirements to achieve process validation and
462462 ongoing minimum testing requirements once a licensee
463463 has achieved process validation ,
464464 b. requiring licensees to track their marijuana and
465465 marijuana product inventory with the Department's
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517517 designated seed-to-sale system provided the Department
518518 has selected a seed-to-sale system. This requirement
519519 for compliance with the seed-to-sale system shall be
520520 mandatory for licensees whether compliance with seed-
521521 to-sale system is mandatory for all licensees ,
522522 c. record and document retention policies, which at a
523523 minimum shall require licensees to retain all
524524 documents and records related to process val idation.
525525 Such records shall be main tained by the licensee for
526526 as long as the licensee is continuing to operate under
527527 that validated process. L icensees must retain all
528528 such documents and records for at least four (4) years
529529 after the licensee has stopped using the validated
530530 process or after the licensee has made a significant
531531 process change to a validated process change. Any
532532 significant process to a licensee's validated
533533 processes is subject to the same document retention
534534 requirements and must be retained for as long as the
535535 significant process change is part of an ongoing
536536 validated process, and for at least four (4) years
537537 after the licensee has stopped using the validated
538538 process or after the licensee has made a subsequent
539539 significant process change to the validated process ,
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591591 d. testing requirements to maintain process validation
592592 when a licensee has made a significant process change
593593 to a validated process,
594594 e. requiring licensees to keep all records and documents
595595 related to their pro cess validation read y and
596596 accessible at the address listed on their marijuana
597597 business license for inspection or audit by the
598598 Authority without any notice from the Authority,
599599 f. a process to revoke a lice nsee's authority to operate
600600 under process validation,
601601 g. punishment for willful violations of process
602602 validation that, at a min imum, would prohibit a
603603 licensee from operating under process validation for
604604 five (5) years and the assessment of fine and fees by
605605 the Authority as allowed by law,
606606 h. an annual registration fee not to exceed Two Thousand
607607 Five Hundred Dollars ($2,500.00) per licensee to be
608608 deposited in the Oklahoma Medical Marijuana Revolving
609609 Fund for the enforcement of law and regulation by the
610610 Authority, and
611611 i. provided no law, rule, or regulation sh all prohibit
612612 medical marijuana testing labs from offering services
613613 to licensees to achieve and manage pro cess validation
614614 for consideration;
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666666 3. Controlled access areas for storage of medical mariju ana and
667667 medical marijuana product test samples, waste and r eference
668668 standards;
669669 4. Records to be retained and computer systems to be utilized
670670 by the laboratory;
671671 5. The possession, storage and use by the laborator y of
672672 reagents, solutions and reference stan dards;
673673 6. A certificate of analysis (COA) for each lot of reference
674674 standard;
675675 7. The transport and disposal of unused marijuana, marijuana
676676 products and waste;
677677 8. The mandatory use by a laboratory of an inventor y tracking
678678 system to ensure all harvest and production batches or samples
679679 containing medical marijuana , medical marijuana concentrate or
680680 medical marijuana products are identified and tracked f rom the point
681681 they are transferred from a medical marijuana busi ness, a patient or
682682 a caregiver through the point of transfer, destruction or disposal .
683683 The inventory tracking system reporting shall include the results of
684684 any tests that are conducted on med ical marijuana, medical marijuana
685685 concentrate or medical marijua na product;
686686 9. Standards of performance;
687687 10. The employment of laboratory personnel;
688688 11. A written standard operating procedure manual to be
689689 maintained and updated by the laboratory;
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741741 12. The successful participation in a Department -approved
742742 proficiency testing program for each testing category listed in this
743743 section, in order to obtain and maintain cer tification;
744744 13. The establishment of and adherence to a quality assurance
745745 and quality control program to ensure sufficient monitoring of
746746 laboratory processes and quality of results reported;
747747 14. The immediate recall of medical marijuana or medical
748748 marijuana products that test above allowable thresholds or are
749749 otherwise determined to be unsa fe;
750750 15. The establishment by the laboratory of a system to docume nt
751751 the complete chain of custody for sample s from receipt through
752752 disposal;
753753 16. The establishment by the laboratory of a system to retain
754754 and maintain all required records , including business records, and
755755 processes to ensure results are reported in a time ly and accurate
756756 manner; and
757757 17. Any other aspect of laboratory testing of medical marijuana
758758 or medical marijuana product deemed necessary by the Department.
759759 O. A medical marijuana test ing laboratory shall promptly
760760 provide the Department or designee of th e Department access to a
761761 report of a test and any underlying data that is conducted on a
762762 sample at the request of a medical marijuana business or qualified
763763 patient. A medical marijuana testing laboratory shall also provide
764764 access to the Department or desi gnee of the Department to laboratory
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816816 premises and to any material or information requested by the
817817 Department to determine compliance with the requirements of this
818818 section.
819819 P. A medical marijuana testing laboratory shall retain all
820820 results of laboratory te sts conducted on marijuana or products for a
821821 period of at least seven (7) years and shall make them av ailable to
822822 the Department upon request.
823823 Q. A medical marijuana testing laboratory shall test samples
824824 from each harvest batch or, product batch, or samples consistent
825825 with the promulgated rules fo r process validation, as appropriate,
826826 of medical marijuana, medical marijuana concentrate and medical
827827 marijuana product for each of the following categories of testi ng,
828828 consistent with standards developed by the Co mmissioner:
829829 1. Microbials;
830830 2. Mycotoxins;
831831 3. Residual solvents;
832832 4. Pesticides;
833833 5. Tetrahydrocannabinol (THC) and other cannabinoid potency;
834834 6. Terpenoid type and concentration ; and
835835 7. Heavy metals.
836836 R. A licensed medical marijuana testing laboratory shall test
837837 each individual harvest batch . A grower shall separate each harvest
838838 lot of usable marijua na into harvest batches containing no more tha n
839839 fifteen (15) pounds, with the exception of any plant mate rial to be
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891891 sold to a licensed processor for the purposes of turning the plant
892892 material into concentrate which may be separated into harvest
893893 batches of no more than fifty (50) pounds . A processor shall
894894 separate each medical marijuana production lot into pr oduction
895895 batches containing no more tha n four (4) liters of concentrate or
896896 nine (9) pounds for nonliquid products, and for final products, the
897897 Oklahoma Medical Marijuana Authority shall be authorized to
898898 promulgate rules on final products as necessary . Provided, however,
899899 the Authority shall not req uire testing of final products less often
900900 than every one thousand (1,000) grams of THC. As used in this
901901 subsection, "final products" shall include, but not be limited to,
902902 cookies, brownies, candies, gummies, beve rages and chocolates .
903903 S. Medical marijuana testing laboratory licensure shall be
904904 contingent upon successful on-site inspection, successful
905905 participation in proficiency testing and ongoing compliance with the
906906 applicable requirements in this section.
907907 T. A medical marijuana testing laboratory shal l be inspected
908908 prior to initial licensure and up to two (2) times per year
909909 thereafter by an inspector approved by the Authority. The Authority
910910 may enter the licensed premises of a testing laboratory to conduct
911911 investigations and additional inspections whe n the Authority
912912 believes an investigation or additi onal inspection is necessary due
913913 to a possible violation of applicable laws, rules or regulations.
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965965 U. Medical marijuana testing laboratories shall obtain
966966 accreditation by an accrediting body approved by the Commissioner
967967 within one (1) year of the date the initial license is issued.
968968 Renewal of any medical marijua na testing laboratory license shall be
969969 contingent upon accreditation in accordance with this subsection .
970970 All medical marijuana testing laborator ies shall obtain
971971 accreditation prior to applying for and receiving a medical
972972 marijuana testing laboratory licen se.
973973 V. Unless authorized by the provisions of this section, a
974974 commercial grower shall not transfer or se ll medical marijuana and a
975975 processor shall not transfer, sell or process into a concentrate or
976976 product any medical marijuana, medical marijuana concent rate or
977977 medical marijuana product unless samples from each harvest batch or,
978978 production batch, or samples consistent with the promulgated rules
979979 for process validation from which that medical mariju ana, medical
980980 marijuana concentrate or med ical marijuana product was derived has
981981 been tested by a medical marijuana testin g laboratory and passed all
982982 contaminant tests required by the Oklahoma Medical Marijuana and
983983 Patient Protection Act and applicable laws , rules and regulations.
984984 A licensed commercial grower may transfer medical marijuana that has
985985 failed testing to a licensed processor only for the purposes of
986986 decontamination or remediation and only in accordance with the
987987 provisions of the Oklahoma Medical Marijuana and Patient Protection
988988 Act and the rules and regulations of the Department . Remediated and
989989
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10401040 decontaminated medical marijuana may be returned only to the
10411041 originating licensed commercial grower.
10421042 W. Kief shall not be transferred or sold except as authorized
10431043 in the rules and regulations o f the Department.
10441044 SECTION 2. It being immediately neces sary for the preservation
10451045 of the public peace, health or safety, an emergency is hereby
10461046 declared to exist, by reason whereof this act shall take effec t and
10471047 be in full force from and after its passage an d approval.
10481048
10491049 58-2-2763 MR 1/20/2022 10:31:26 PM