Oklahoma 2022 Regular Session

Oklahoma House Bill HB4056 Compare Versions

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1-An Act
2-ENROLLED HOUSE
3-BILL NO. 4056 By: Marti, Davis, Talley, and
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28+STATE OF OKLAHOMA
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30+2nd Session of the 58th Legislature (2022)
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32+CONFERENCE COMMITTEE
33+SUBSTITUTE
34+FOR ENGROSSED
35+HOUSE BILL NO. 4056 By: Marti, Davis, Talley, and
436 McDugle of the House
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638 and
739
840 Paxton of the Senate
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48+CONFERENCE COMMITTEE SUBSTITUTE
1249
1350 An Act relating to medical marijuana; amending 63
1451 O.S. 2021, Section 427.17, as amended by Section 17
1552 of Enrolled Senate Bill No. 1543 of the 2nd Session
1653 of the 58th Oklahoma Legislature, which relates to
1754 the Oklahoma Medical Marijuana and Patient Protection
1855 Act; directing certain entities to provide
1956 recommendations, standards and operating proce dures
2057 to the Oklahoma Medical Marijuana Authority;
2158 directing the Authority to promulgate rule s;
2259 requiring licensed medical marijuana testing
2360 laboratories to comply with rules; providing for
2461 license revocation; and declaring an emergency .
2562
2663
2764
2865
29-SUBJECT: Medical marijuana
30-
3166 BE IT ENACTED BY THE PEOPLE OF THE S TATE OF OKLAHOMA:
32-
3367 SECTION 1. AMENDATORY 63 O.S. 2021, Section 427.17, as
3468 amended by Section 17 of Enrolled Senate Bill No. 1543 of the 2nd
3569 Session of the 58th Oklahoma Legislature, is amended to read as
3670 follows:
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3796
3897 Section 427.17 A. There is hereby created a medical marijuana
3998 testing laboratory licens e as a category of the medical marijuana
4099 business license. The Oklahoma Medical Marijuana Authority is
41100 hereby enabled to monitor, inspect and audit a licensed testing
42101 laboratory under the Oklahoma Medical Marijuana and Patient
43102 Protection Act.
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45103 B. 1. The Authority is hereby authorized to contract with a
46-private laboratory for the purpose of conducting compliance testing ENR. H. B. NO. 4056 Page 2
104+private laboratory for the purpose of conducting compliance testing
47105 of medical marijuana testing laboratories licensed in th is state.
48106 Any such laboratory under contract for compliance t esting shall be
49107 prohibited from conducting any other commercial medical ma rijuana
50108 testing in this state. The laboratory the Authority contracts with
51109 for compliance testing shall not employ, or be owned by, the
52110 following:
111+1. Any
112+a. any individual that has a direct or indirect interest in a
113+licensed medical marijuana business; or
114+2. Any
115+b. any individual or his or her spouse, parent, child, spouse
116+of a child, sibling or spouse of a sibling that has an applica tion
117+for a medical marijuana business license pending before the
118+Authority or is a member of the board of directors of a medi cal
119+marijuana business, or is an individual financially interested in
53120
54-1. Any
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56-a. any individual that has a direct or indirect interest
57-in a licensed medical marijuana business ;, or
58-
59-2. Any
60-
61-b. any individual or his or her spouse, parent, child,
62-spouse of a child, sibling or spouse of a sibling that
63-has an application for a medical marijuana business
64-license pending before the Authority or is a member of
65-the board of directors of a medi cal marijuana
66-business, or is an individual financially interested
67-in any licensee or medical marijuana business located
68-within this state.
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146+any licensee or medical marijuana business located within this
147+state.
70148 2. The private laboratory under contract with the Authority for
71149 compliance testing and a board or committee comprised of licensed
72150 Oklahoma medical marijuana laboratories currently accredited by the
73151 International Organization for Standardizatio n (ISO) shall provide
74152 to the Authority its recommendations for all equipment and standards
75153 to be utilized by licensed medical marijuana testing laboratories
76154 when testing samples of medical marijuana, medical marijuana
77155 concentrate, and medical marijuana product s as well as standard
78156 operating procedures when extracting and testing medical marijuana,
79157 medical marijuana concentrate, and medical marijuana products. The
80158 recommendations shall be submitted to the Authority no later than
81159 June 1, 2023. The Authority shall have ninety (90) days from the
82160 date it receives the recommendations to promulgate new rules or
83161 modify its current rules for laboratory standards and testing.
84162 Beginning June 1, 2024, medical marijuana testing laboratories
85163 renewing their medical marijuana business license shall be subject
86164 to and comply with any new or modified rules relating to the testing
87165 of medical marijuana, medical marijuana concentrate, and medical
88166 marijuana products. The refusal or failure of a medical marijuana
89167 testing laboratory licensee to comply with new or modified rules
90-relating to laboratory standards and testing procedures p romulgated ENR. H. B. NO. 4056 Page 3
168+relating to laboratory standards and testing procedures p romulgated
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91195 under the provisions of this paragraph shall result in the permanent
92196 revocation of the medical marijuana testing laboratory license.
93-
94197 C. The Authority shall develop acceptable testin g practices
95198 including, but not limited to, testing, standards, qual ity control
96199 analysis, equipment certification and calibration, and chemical
97200 identification and substances used.
98-
99201 D. A person who is a direct beneficial own er of a medical
100202 marijuana dispensary, m edical marijuana commercial grower or medical
101203 marijuana processor shall not be an owner of a laboratory.
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103204 E. A laboratory and a laboratory applicant shall comply with
104205 all applicable local ordinances including , but not limited to,
105206 zoning, occupancy, licensi ng and building codes.
106-
107207 F. A separate license shall be require d for each specific
108208 laboratory.
109-
110209 G. A medical marijuana testing laboratory license may be issued
111210 to a person who perform s testing on medical marijuana a nd medical
112211 marijuana products for medical marijuana businesses, medical
113212 marijuana research facilities, m edical marijuana education
114213 facilities, and testing on marijuana and marijuana products grown or
115214 produced by a patient or caregiver on behalf of a patien t, upon
116215 verification of registration . A medical marijuana testing
117216 laboratory may also conduct research related to the development and
118217 improvement of its testing practices and procedures. No state-
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119244 approved medical marijuana testing facility shall operate unless a
120245 medical laboratory director is on site during operational hours.
121-
122246 H. Laboratory applicants and licensees shall comply with the
123247 application requirements of this section and shall submit such other
124248 information as required for a medical marijuana bu siness applicant,
125249 in addition to any inform ation the Authority may request for initial
126250 approval and periodic evaluations during the approval period.
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128251 I. A medical marijuana testing laboratory may accept samples of
129252 medical marijuana, medical marijuana conc entrate or medical
130253 marijuana product from a medical marijuana business, medical
131254 marijuana research facilit y or medical marijuana education facility
132255 for testing purposes only, which purposes may include the provision
133256 of testing services for samples submitte d by a medical marijuana
134257 business for product development. The Authority may require a
135-medical marijuana business to submit a sample of medical marijuana, ENR. H. B. NO. 4056 Page 4
258+medical marijuana business to submit a sample of medical marijuana,
136259 medical marijuana concentrate or medical marijuana product to a
137260 medical marijuana testing or quality assurance laboratory upon
138261 demand.
139-
140262 J. A medical marijuana testing laboratory may accept sample s of
141263 medical marijuana, medical marijuana concentrate or medical
142264 marijuana product from an individual person for testing only under
143265 the following conditions:
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145266 1. The individual person is a patient or careg iver pursuant to
146267 the Oklahoma Medical Marijuana and Patient Protection Act or is a
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147294 participant in an approved clinical or observational study conducted
148295 by a research facility; and
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150296 2. The medical marijuana tes ting laboratory shall require the
151297 patient or caregiver to produce a valid patient license and curr ent
152298 and valid photo identification.
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154299 K. A medical marijuana testing laboratory may transfer samples
155300 to another medical m arijuana testing laboratory for testi ng. All
156301 laboratory reports provided to or by a medical marijuana business or
157302 to a patient or careg iver shall identify the medical marijuana
158303 testing laboratory that actually conducted the test.
159-
160304 L. A medical marijuana t esting laboratory may utilize a
161305 licensed medical marijuana transporter to transport s amples of
162306 medical marijuana, medical marijuana conc entrate and medical
163307 marijuana product for testing, in accordance with the Oklahoma
164308 Medical Marijuana and Patient Protect ion Act and the rules adopted
165309 pursuant thereto, between the originating medical marij uana business
166310 requesting testing services and the d estination laboratory
167311 performing testing services.
168-
169312 M. The medical marijuana testing laboratory shall establish
170313 policies to prevent the existence of or app earance of undue
171314 commercial, financial or other in fluences that may diminish the
172315 competency, impartia lity and integrity of the testing processes or
173316 results of the laboratory, or that may diminish public confidence in
174317 the competency, impartiality and integr ity of the testing processes
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175344 or results of the lab oratory. At a minimum, employees, owners or
176345 agents of a medical marijuana testing laboratory who participate in
177346 any aspect of the analysis and results of a sample are pro hibited
178347 from improperly influencing the testing process, improperly
179348 manipulating data or improperly benefiting from any ongoing
180-financial, employment, personal or business relationship with the ENR. H. B. NO. 4056 Page 5
349+financial, employment, personal or business relationship with the
181350 medical marijuana business that provided the sample. A medical
182351 marijuana testing laboratory shal l not test samples for any medical
183352 marijuana business in which an owner, employee or agent of the
184353 medical marijuana testing laboratory has any form of ownership or
185354 financial interest in the medical marijuana business.
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187355 N. The Authority, pursuant to rules promulgated by the
188356 Executive Director of the Authority, shall develop standards,
189357 policies and procedures as necessary for:
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191358 1. The cleanliness and orderliness of a laboratory premise s and
192359 the location of the laboratory in a secure location, and inspectio n,
193360 cleaning and maintenance of any equipment or utensils used for the
194361 analysis of test samples;
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196362 2. Testing procedures, testing standards for cannabinoid and
197363 terpenoid potency and safe levels of contaminants, and remediation
198364 procedures;
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200365 3. Controlled access areas for storage of medical marijuana and
201366 medical marijuana product test samples, waste and reference
202367 standards;
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204394 4. Records to be retained and computer systems to be utilized
205395 by the laboratory;
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207396 5. The possession, storage and use by the laboratory of
208397 reagents, solutions and reference standards;
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210398 6. A certificate of analysis (COA) for each lot of reference
211399 standard;
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213400 7. The transport and disposal of unused marijuana, marijuana
214401 products and waste;
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216402 8. The mandatory use by a laboratory of an invent ory tracking
217403 system to ensure all harvest and production batches or samples
218404 containing medical marijuana, medical marijuana concentrate or
219405 medical marijuana products are identified and tracke d from the point
220406 they are transferred from a medical marijuana bu siness, a patient or
221407 a caregiver through the point of transfer, destruction or disposal.
222408 The inventory tracking system reporting shall include the results of
223409 any tests that are conducted on medical marijuana, medical marijuana
224410 concentrate or medical marij uana product;
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226411 9. Standards of performance;
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228412 10. The employment of laboratory personnel;
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230413 11. A written standard operating procedure manual to be
231414 maintained and updated by the laboratory;
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233415 12. The successful participation in a proficiency testing
234416 program approved by the Executive Director for each testing category
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235443 listed in this section, in order to obtain and maintain
236444 certification;
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238445 13. The establishment of and adherence to a quality assurance
239446 and quality control program to ensure sufficient monitori ng of
240447 laboratory processes and quality of results reported;
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242448 14. The immediate recall of medical marijuana or medical
243449 marijuana products that test above allowable thresholds or are
244450 otherwise determined to be unsa fe;
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246451 15. The establishment by the laborato ry of a system to document
247452 the complete chain of custody for samples from receipt through
248453 disposal;
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250454 16. The establishment by the laboratory of a system to retain
251-and maintain all required records, including business records, and
455+and maintain all required records including business records, and
252456 processes to ensure result s are reported in a timely and accurate
253457 manner; and
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255458 17. Any other aspect of laboratory testing of medical marijuana
256459 or medical marijuana product deemed necessary by the Executive
257460 Director.
258-
259461 O. A medical marijuana test ing laboratory shall promptly
260462 provide the Authority or designee of the Authority access to a
261463 report of a test and any underlying data that is conducted on a
262464 sample at the request of a medical marijuana business or qualified
263465 patient. A medical marijuana testing laboratory shall also provide
264466 access to the Authority or designee of the Authority to laboratory
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265493 premises and to any material or information requested by t he
266494 Authority to determine compliance w ith the requirements of this
267495 section.
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269496 P. A medical marijuana testing laboratory shall retain all
270-results of laboratory tests conducted on marijuana or products for a ENR. H. B. NO. 4056 Page 7
497+results of laboratory tests conducted on marijuana or products for a
271498 period of at least seven (7) years and shall make them available to
272499 the Authority upon request.
273-
274500 Q. A medical marijuana testing laboratory shall test samples
275501 from each harvest batch or product batch, as appropriate, of medical
276502 marijuana, medical marijuana concentrate and medical marij uana
277503 product for each of the following categories of testing , consistent
278504 with standards developed by the Executive Director:
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280505 1. Microbials;
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282506 2. Mycotoxins;
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284507 3. Residual solvents;
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286508 4. Pesticides;
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288509 5. Tetrahydrocannabinol (THC) and other cannab inoid potency;
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290510 6. Terpenoid type and concentration ; and
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292511 7. Heavy metals.
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294512 R. A licensed medical marijuana testing laboratory shall test
295513 each individual harvest batch. A grower shall separate each harvest
296514 lot of usable marijuana into harvest batches cont aining no more than
297515 fifteen (15) pounds, with the exception of any plant material to be
298516 sold to a licensed processor for the purposes of turning the plant
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299543 material into concentrate which may be separated into harvest
300544 batches of no more than fifty (50) poun ds. A processor shall
301545 separate each medical marijuana production lot int o production
302546 batches containing no more than four (4) liters of concentrate or
303547 nine (9) pounds for nonliquid products, and for final products, the
304548 Oklahoma Medical Marijuana Authority shall be authorized to
305549 promulgate rules on final products as necessary . Provided, however,
306550 the Authority shall not require testing of final products less often
307551 than every one thousand (1,000) grams of THC. As used in this
308552 subsection, "final products" shall include, but not be limited to,
309553 cookies, brownies, candies, gummies, beverages and chocolates.
310-
311554 S. Medical marijuana testing laboratory licensure shall be
312555 contingent upon successful on-site inspection, successful
313556 participation in proficiency testing an d ongoing compliance with the
314557 applicable requirements in this section.
315- ENR. H. B. NO. 4056 Page 8
316558 T. A medical marijuana testing laboratory shall be inspected
317559 prior to initial licensure and up to two (2) times per year
318560 thereafter by an inspector approved by the Authority. The Authority
319561 may enter the licensed premises of a testing laboratory to conduct
320562 investigations and additional inspections when the Authority
321563 believes an investigation or additional inspection is necessary due
322564 to a possible violation of applicable laws, rules or r egulations.
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324565 U. Medical marijuana testing laboratories shall obtain
325566 accreditation by an accrediting body approved by the Executive
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326593 Director within one (1) year of the date the initial license is
327594 issued. Renewal of any medical marijuana testing laboratory license
328595 shall be contingent upon accreditation in accordance with this
329596 subsection. All medical marijuana testing laboratories shall obtain
330597 accreditation prior to applying for and receiving a medical
331598 marijuana testing laboratory license.
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333599 V. Unless authorized by the provisions of this section, a
334600 commercial grower shall not tran sfer or sell medical marijuana and a
335601 processor shall not transfer, sell or process into a concentrate or
336602 product any medical marijuana, medical marijuana concentrate or
337603 medical marijuana product unless samples from each harvest batch or
338604 production batch from which that medical marijuana, medical
339605 marijuana concentrate or medical marijuana product was derived has
340606 been tested by a medical marijuana testing laboratory and passed all
341607 contaminant tests required b y the Oklahoma Medical Marijuana and
342608 Patient Protection Act and applicable laws, rules and regulations.
343609 A licensed commercial grower may transfer medical marijuana that has
344610 failed testing to a licensed processor only for the purposes of
345611 decontamination or remediation and only in accordance with the
346612 provisions of the Oklahoma Medical Marijuana and Patient Protection
347613 Act and the rules and regulations promulgated by the Executive
348614 Director. Remediated and decontaminated medical marijuana may be
349615 returned only to the originating licensed comme rcial grower.
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351642 W. Kief shall not be transferred or sold except as authorized
352643 in the rules and regulations promulgated by the Executive Director.
353-
354644 SECTION 2. It being immediately necessary for the preservation
355645 of the public peace, health or safety, an emergency is hereby
356646 declared to exist, by rea son whereof this act shall take effect and
357647 be in full force from and after its passage an d approval.
358648
359- ENR. H. B. NO. 4056 Page 9
360-
361-Passed the House of Representatives the 18th day of May, 2022.
649+58-2-11561 GRS 05/16/22
362650
363651
364-
365-
366- Presiding Officer of the House
367- of Representatives
368-
369-
370-Passed the Senate the 19th day of May, 2022.
371-
372-
373-
374-
375- Presiding Officer of the Senate
376-
377-
378-
379-OFFICE OF THE GOVERNOR
380-Received by the Office of the Governor this ____________________
381-day of ___________________, 20_______, at _______ o'clock _______ M.
382-By: _________________________________
383-Approved by the Governor of the State of Oklahoma this _____ ____
384-day of ___________________, 20_______, at _______ o'clock _______ M.
385-
386-
387- _________________________________
388- Governor of the State of Oklahoma
389-
390-OFFICE OF THE SECRETARY OF STATE
391-Received by the Office of the Secretary of State this __________
392-day of ___________________, 20_______, at _______ o'clock _______ M.
393-By: _________________________________