Oklahoma 2022 Regular Session

Oklahoma House Bill HB3999 Compare Versions

Only one version of the bill is available at this time.
OldNewDifferences
11
22
33 Req. No. 8558 Page 1 1
44 2
55 3
66 4
77 5
88 6
99 7
1010 8
1111 9
1212 10
1313 11
1414 12
1515 13
1616 14
1717 15
1818 16
1919 17
2020 18
2121 19
2222 20
2323 21
2424 22
2525 23
2626 24
2727
2828 STATE OF OKLAHOMA
2929
3030 2nd Session of the 58th Legislature (2022)
3131
3232 HOUSE BILL 3999 By: Dobrinski
3333
3434
3535
3636
3737
3838 AS INTRODUCED
3939
4040 An Act relating to medical marijuana; amending 63
4141 O.S. 2021, Section 427.17, which relates to the
4242 Oklahoma Medical Marijuana and Patient Protection
4343 Act; prohibiting medical marijuana testing
4444 laboratories from accepting samples directly from
4545 medical marijuana growers; authorizing employees of
4646 the Oklahoma Medical Mari juana Authority to collect
4747 and submit samples; directing the Authority t o retain
4848 test samples for certain amount of time; and
4949 providing an effective date .
5050
5151
5252
5353
5454 BE IT ENACTED BY THE PEOPL E OF THE STATE OF OKLAHOMA:
5555 SECTION 1. AMENDATORY 63 O.S. 2 021, Section 427.17, is
5656 amended to read as follows:
5757 Section 427.17 A. There is hereby created a medical marijuana
5858 testing laboratory license as a category of the medical marijuana
5959 business license. The Oklahoma Medical Marijuana Authority is
6060 hereby enabled to monitor, inspect and audit a licensed testin g
6161 laboratory under the Oklahoma Medical Marijuana and Patient
6262 Protection Act.
6363 B. The Authority is hereby authorized to contract with a
6464 private laboratory for the purpose of conducting compliance te sting
6565
6666 Req. No. 8558 Page 2 1
6767 2
6868 3
6969 4
7070 5
7171 6
7272 7
7373 8
7474 9
7575 10
7676 11
7777 12
7878 13
7979 14
8080 15
8181 16
8282 17
8383 18
8484 19
8585 20
8686 21
8787 22
8888 23
8989 24
9090
9191 of medical marijuana testing laboratories licensed i n this state.
9292 Any such laboratory under contract for compliance testing shall be
9393 prohibited from conducting any other commercial medical marijuana
9494 testing in this state . The laboratory the Authori ty contracts with
9595 for compliance testing shall not employ, or be owned by, the
9696 following:
9797 1. Any individual that has a direct or indirect interest in a
9898 licensed medical marijuana business; or
9999 2. Any individual or his or her spouse, parent, child, spouse
100100 of a child, sibling or spouse of a sibling that has an app lication
101101 for a medical marijuana business license pending before the
102102 Department Authority or is a member of the board of directors of a
103103 medical marijuana business, or is an individual financially
104104 interested in any licensee or medical marijuana business loc ated
105105 within this state.
106106 C. The Authority shall develop acceptable testin g practices
107107 including, but not limited to, testing, standards, quality control
108108 analysis, equipment certification and calibration, a nd chemical
109109 identification and substances used.
110110 D. A person who is a direct beneficial owne r of a medical
111111 marijuana dispensary, medical marijuana commercial grower or medical
112112 marijuana processor shall not be an owner of a laboratory.
113113
114114 Req. No. 8558 Page 3 1
115115 2
116116 3
117117 4
118118 5
119119 6
120120 7
121121 8
122122 9
123123 10
124124 11
125125 12
126126 13
127127 14
128128 15
129129 16
130130 17
131131 18
132132 19
133133 20
134134 21
135135 22
136136 23
137137 24
138138
139139 E. A laboratory and a laboratory applicant sha ll comply with
140140 all applicable local ordinances including , but not limited to,
141141 zoning, occupancy, licensing and building codes.
142142 F. A separate license shall be required for each specific
143143 laboratory.
144144 G. A medical marijuana testing laboratory license may b e issued
145145 to a person who performs testing on medical marijuana and medical
146146 marijuana products for medical marijuana businesses, medical
147147 marijuana research facilities, medical marijuana education
148148 facilities, and testin g on marijuana and marijuana products g rown or
149149 produced by a patien t or caregiver on behalf of a patient, upon
150150 verification of registration . A medical marijuana testing
151151 laboratory may also conduct research related to the development and
152152 improvement of its testing practi ces and procedures. No state-
153153 approved medical marij uana testing facility shall operate unless a
154154 medical laboratory director is on site during operational hours.
155155 H. Laboratory applicants and licensees shall comply with the
156156 application requirements of this section and shall submit such other
157157 information as required for a medical marijuana business applicant,
158158 in addition to any information the Authority may request for initial
159159 approval and periodic evaluations during the approval period.
160160 I. A 1. Except as provided in paragraph 2 of this subsection,
161161 a medical marijuana testing laboratory may accept samples of medical
162162 marijuana, medical marijuana concentrate or medical marijuana
163163
164164 Req. No. 8558 Page 4 1
165165 2
166166 3
167167 4
168168 5
169169 6
170170 7
171171 8
172172 9
173173 10
174174 11
175175 12
176176 13
177177 14
178178 15
179179 16
180180 17
181181 18
182182 19
183183 20
184184 21
185185 22
186186 23
187187 24
188188
189189 product from a medical marijuana business , medical marijuana
190190 research facility or medical marijuana education facility for
191191 testing purposes only, which purposes may include the provision of
192192 testing services for samples submitted by a medical marijuana
193193 business for product development . The Department Authority may
194194 require a medical mar ijuana business to submit a sample of medical
195195 marijuana, medical marijuan a concentrate or medical marijuana
196196 product to a medical marijuana testing or quality assurance
197197 laboratory upon demand.
198198 2. A medical marijuana testing laboratory shall be prohibited
199199 from accepting test samples of medical marijuana directly from a
200200 medical marijuana grower. An employee of the Authority shall be
201201 authorized to collect samples from the harvest batch of the medical
202202 marijuana grower and shall submit such samples for testing to the
203203 medical marijuana testing lab oratory on behalf of the medical
204204 marijuana grower and i n accordance with the provisi ons of this
205205 section. All test samples collected from a medical marijuana grower
206206 by an employee of the Authority shall be retained by the Authority
207207 for a minimum of sixty (60) days.
208208 J. A medical marijuana testing laboratory may accept samples of
209209 medical marijuana, medical marijuana concentrate or medical
210210 marijuana product from an individual person for testing only under
211211 the following conditions:
212212
213213 Req. No. 8558 Page 5 1
214214 2
215215 3
216216 4
217217 5
218218 6
219219 7
220220 8
221221 9
222222 10
223223 11
224224 12
225225 13
226226 14
227227 15
228228 16
229229 17
230230 18
231231 19
232232 20
233233 21
234234 22
235235 23
236236 24
237237
238238 1. The individual person is a patient or c aregiver pursuant to
239239 the Oklahoma Medical Marijuana and Patient Protection Act or is a
240240 participant in an approved clinical or observ ational study conducted
241241 by a research facility; and
242242 2. The medical marijuana testing laboratory shall require the
243243 patient or caregiver to produce a valid patient license and current
244244 and valid photo identification.
245245 K. A medical marijuana testing laborator y may transfer samples
246246 to another medical marijuana testing laboratory fo r testing. All
247247 laboratory reports provided to or b y a medical marijuana business or
248248 to a patient or caregiver shall identify the medical marijuana
249249 testing laboratory that actually co nducted the test.
250250 L. A medical marijuana testing laboratory may utilize a
251251 licensed medical marijuana transporter to transpo rt samples of
252252 medical marijuana, medical marijuana concentrate and medical
253253 marijuana product for testing, in accordance wit h the Oklahoma
254254 Medical Marijuana and Patient Protection Act and the rules adopted
255255 pursuant thereto, between the originating medical m arijuana business
256256 requesting testing services and the destination laboratory
257257 performing testing services.
258258 M. The medical marijuana testing laboratory shall establish
259259 policies to prevent the existence of o r appearance of undue
260260 commercial, financial or othe r influences that may diminish the
261261 competency, impartiality and integrity of the testing processes or
262262
263263 Req. No. 8558 Page 6 1
264264 2
265265 3
266266 4
267267 5
268268 6
269269 7
270270 8
271271 9
272272 10
273273 11
274274 12
275275 13
276276 14
277277 15
278278 16
279279 17
280280 18
281281 19
282282 20
283283 21
284284 22
285285 23
286286 24
287287
288288 results of the laboratory, or that may diminish public confidence in
289289 the competency, impartiality and i ntegrity of the testing processes
290290 or results of the laboratory. At a minimum, employees, owners or
291291 agents of a medical marijuana testing laboratory who participate in
292292 any aspect of the analysis and results of a sample are prohibited
293293 from improperly influe ncing the testing process, improperly
294294 manipulating data or improperly benefiting from any ongoing
295295 financial, employment, personal or business relationship with the
296296 medical marijuana business that provided the sample. A medical
297297 marijuana testing laboratory shall not test samples for any medical
298298 marijuana business in which an owner, employee or agent of the
299299 medical marijuana testing laboratory has any form of ownership or
300300 financial interest in the medical marijuana business.
301301 N. The Department Authority, pursuant to rules promulgated by
302302 the State Commissione r of Health, shall develop standards, policies
303303 and procedures as necessary for:
304304 1. The cleanliness and orderliness of a laboratory premises a nd
305305 the location of the laboratory in a secure location, and ins pection,
306306 cleaning and maintenance of any equipment or utensils used for the
307307 analysis of test samples;
308308 2. Testing procedures, testing standards for cannabinoid and
309309 terpenoid potency and safe le vels of contaminants, and remediation
310310 procedures;
311311
312312 Req. No. 8558 Page 7 1
313313 2
314314 3
315315 4
316316 5
317317 6
318318 7
319319 8
320320 9
321321 10
322322 11
323323 12
324324 13
325325 14
326326 15
327327 16
328328 17
329329 18
330330 19
331331 20
332332 21
333333 22
334334 23
335335 24
336336
337337 3. Controlled access areas for storage of medical marijuana and
338338 medical marijuana product test samples, waste and reference
339339 standards;
340340 4. Records to be retained and computer systems to be utilized
341341 by the laboratory;
342342 5. The possession, storage and use by the laborato ry of
343343 reagents, solutions and reference standards;
344344 6. A certificate of analysis (COA) for each lot of reference
345345 standard;
346346 7. The transport and disposal of unused marijuana, marijuana
347347 products and waste;
348348 8. The mandatory use by a laboratory of an invento ry tracking
349349 system to ensure all harvest and production batches or samples
350350 containing medical marijuana, medical marijuana concentrate or
351351 medical marijuana products are identified and tracked f rom the point
352352 they are transferred from the Authority, a medical marijuana
353353 business, or a patient or a caregiver through the point of transfer,
354354 destruction or disposal. The inventory tracking system reporting
355355 shall include the results of any tests that are conducted on med ical
356356 marijuana, medical marijuana concentrate or medical marijuana
357357 product;
358358 9. Standards of performance;
359359 10. The employment of laboratory personnel;
360360
361361 Req. No. 8558 Page 8 1
362362 2
363363 3
364364 4
365365 5
366366 6
367367 7
368368 8
369369 9
370370 10
371371 11
372372 12
373373 13
374374 14
375375 15
376376 16
377377 17
378378 18
379379 19
380380 20
381381 21
382382 22
383383 23
384384 24
385385
386386 11. A written standard operating procedure manual to be
387387 maintained and updated by the laboratory;
388388 12. The successful participation in a Department-approved an
389389 Authority-approved proficiency testing p rogram for each testing
390390 category listed in this section, in order to obtain and maintain
391391 certification;
392392 13. The establishment of and adherence to a quality assurance
393393 and quality control program to ensure sufficient monitoring of
394394 laboratory processes and q uality of results reported;
395395 14. The immediate recall of medical marijuana or medical
396396 marijuana products that test above allowable thresholds or are
397397 otherwise determined to be unsa fe;
398398 15. The establishment by the laboratory of a system to document
399399 the complete chain of custody for samples from receipt through
400400 disposal;
401401 16. The establishment by the laboratory of a system to retain
402402 and maintain all required records , including business records, and
403403 processes to ensure results are reported in a timely and acc urate
404404 manner; and
405405 17. Any other aspect of laboratory testing of medical marijuana
406406 or medical marijuana product deemed necessary by the Department
407407 Authority.
408408 O. A medical marijuana test ing laboratory shall promptly
409409 provide the Department Authority or designee of the Department
410410
411411 Req. No. 8558 Page 9 1
412412 2
413413 3
414414 4
415415 5
416416 6
417417 7
418418 8
419419 9
420420 10
421421 11
422422 12
423423 13
424424 14
425425 15
426426 16
427427 17
428428 18
429429 19
430430 20
431431 21
432432 22
433433 23
434434 24
435435
436436 Authority access to a report of a test and any underlying data that
437437 is conducted on a sample at the request of a medical marijuana
438438 business or qualified patient . A medical marijuana testing
439439 laboratory shall also provide access to th e Department Authority or
440440 designee of the Department Authority to laboratory premises and to
441441 any material or information requested by the Department Authority to
442442 determine compliance with the requirements of this section.
443443 P. A medical marijuana testing laboratory shall retain all
444444 results of laboratory tests conducted on marijuana or products for a
445445 period of at least seven (7) years and shall make them available to
446446 the Department Authority upon request.
447447 Q. A medical marijuana testing laboratory shall test samples
448448 from each harvest batch or product batch, as appropriate, of medical
449449 marijuana, medical marijuana concentrate and medical marijuana
450450 product for each of the following categories of testing, consiste nt
451451 with standards developed by the Comm issioner:
452452 1. Microbials;
453453 2. Mycotoxins;
454454 3. Residual solvents;
455455 4. Pesticides;
456456 5. Tetrahydrocannabinol (THC) and other cannabinoid potency;
457457 6. Terpenoid type and concentration ; and
458458 7. Heavy metals.
459459
460460 Req. No. 8558 Page 10 1
461461 2
462462 3
463463 4
464464 5
465465 6
466466 7
467467 8
468468 9
469469 10
470470 11
471471 12
472472 13
473473 14
474474 15
475475 16
476476 17
477477 18
478478 19
479479 20
480480 21
481481 22
482482 23
483483 24
484484
485485 R. A licensed medical marijuana testing laboratory shall test
486486 each individual harvest batch . A grower shall separate each harvest
487487 lot of usable marijuana into harvest batches containing no more tha n
488488 fifteen (15) pounds, with the exception of any plant material to be
489489 sold to a licensed processor for the purposes of turning the plant
490490 material into concentrate which may be separated into harvest
491491 batches of no more than fifty (50) pounds . A processor shall
492492 separate each medical marijuana production lot into production
493493 batches containing no more tha n four (4) liters of concentrate or
494494 nine (9) pounds for nonliquid products, and for final products, the
495495 Oklahoma Medical Marijuana Authority shall be authorized to
496496 promulgate rules on final products as necessary . Provided, however,
497497 the Authority shall not req uire testing of final products less often
498498 than every one thousand (1,000) grams of THC. As used in this
499499 subsection, "final products" shall include, but not be limited to,
500500 cookies, brownies, candies, gummies, beverages and ch ocolates.
501501 S. Medical marijuana testing laboratory licensure shall be
502502 contingent upon successful on -site inspection, successful
503503 participation in proficiency testing and ongoing compliance with the
504504 applicable requirements in this section.
505505 T. A medical marijuana testing laboratory shal l be inspected
506506 prior to initial licensure an d up to two (2) times per year
507507 thereafter by an inspector approved by the Authority . The Authority
508508 may enter the licensed premises of a testing laboratory to conduct
509509
510510 Req. No. 8558 Page 11 1
511511 2
512512 3
513513 4
514514 5
515515 6
516516 7
517517 8
518518 9
519519 10
520520 11
521521 12
522522 13
523523 14
524524 15
525525 16
526526 17
527527 18
528528 19
529529 20
530530 21
531531 22
532532 23
533533 24
534534
535535 investigations and additional inspections whe n the Authority
536536 believes an investigation or additional inspection is necessary due
537537 to a possible violation of applicable laws, rules or regulations.
538538 U. Medical marijuana testing laboratories shall obtain
539539 accreditation by an accrediting body approved by the Commissioner
540540 within one (1) year of the date the initial license is issued .
541541 Renewal of any medical marijuana testing laboratory license shall be
542542 contingent upon accreditation in accordance with this subsection .
543543 All medical marijuana testing laborator ies shall obtain
544544 accreditation prior to applying for and receiving a medical
545545 marijuana testing laboratory license .
546546 V. Unless authorized by the provisions of this section, a
547547 commercial grower shall not transfer or sell medical m arijuana and a
548548 processor shall not transfer, se ll or process into a concentrate or
549549 product any medical marijuana, medical marijuana concentrate or
550550 medical marijuana product unless samples from each harvest batch or
551551 production batch from which that medical marijuana, medical
552552 marijuana concentrate or med ical marijuana product was derived has
553553 been tested by a medical marijuana testin g laboratory and passed all
554554 contaminant tests required b y the Oklahoma Medical Marijuana and
555555 Patient Protection Act and applicabl e laws, rules and regulatio ns.
556556 A licensed commercial grower may transfer medical marijuana that has
557557 failed testing to a licensed processor only for the purposes of
558558 decontamination or remediation and only in accordance with the
559559
560560 Req. No. 8558 Page 12 1
561561 2
562562 3
563563 4
564564 5
565565 6
566566 7
567567 8
568568 9
569569 10
570570 11
571571 12
572572 13
573573 14
574574 15
575575 16
576576 17
577577 18
578578 19
579579 20
580580 21
581581 22
582582 23
583583 24
584584
585585 provisions of the Oklahoma M edical Marijuana and Patien t Protection
586586 Act and the rules and regulations of the Department Authority.
587587 Remediated and decontaminated medical marijuana may be returned only
588588 to the originating licensed commercial grower.
589589 W. Kief shall not be transferred or sold except as authorized
590590 in the rules and regulations of the Department Authority.
591591 SECTION 2. This act shall become effective November 1, 2022.
592592
593593 58-2-8558 GRS 01/18/22