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28	28	STATE OF OKLAHOMA
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30	30	2nd Session of the 58th Legislature (2022)
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32	32	HOUSE BILL 4416 By: Lowe (Dick)
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38	38	AS INTRODUCED
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40	40	An Act relating to medical marijuana; amend ing 63
41	41	O.S. 2021, Section 427.17, which relates to the
42	42	Oklahoma Medical Marijuana and Pat ient Protection
43	43	Act; directing licensed medical marijuana growers to
44	44	annually submit certain information to the Oklahoma
45	45	Medical Marijuana Authority; and providing an
46	46	effective date.
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52	52	BE IT ENACTED BY THE PEOPL E OF THE STATE OF OKLAHOMA:
53	53	SECTION 1. AMENDATORY 63 O.S. 2021, Section 427.17, is
54	54	amended to read as follows:
55	55	Section 427.17 A. There is hereby created a medical marijuana
56	56	testing laboratory li cense as a category of the medical marijuana
57	57	business license. The Oklahoma Medical Marijuana Authority is
58	58	hereby enabled to monitor, inspec t and audit a licensed testing
59	59	laboratory under the Oklahoma Medical Marijuana and Patient
60	60	Protection Act.
61	61	B. The Authority is hereby authorized to contract with a
62	62	private laboratory for the purpose of conducting compliance te sting
63	63	of medical marijuana t esting laboratories licensed in this state .
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90	90	Any such laboratory under contract for compliance testing shall be
91	91	prohibited from conducting any other commercial medical marijuana
92	92	testing in this state. The laboratory the Authori ty contracts with
93	93	for compliance testing shall not employ, or be owned by, the
94	94	following:
95	95	1. Any individual that has a direct or indirect inter est in a
96	96	licensed medical marijuana business; or
97	97	2. Any individual or his or her spouse, parent, child, spouse
98	98	of a child, sibling or spo use of a sibling that has an application
99	99	for a medical marijuana business license pending before the
100	100	Department or is a member of the board of directors of a medical
101	101	marijuana business, o r is an individual financially interested i n
102	102	any licensee or medical marijuana business located within this
103	103	state.
104	104	C. The Authority shall develop acceptable testin g practices
105	105	including, but not limited to, testing, standards, quality control
106	106	analysis, equipment certification and calibration, and c hemical
107	107	identification and substances used.
108	108	D. A person who is a direct beneficial owne r of a medical
109	109	marijuana dispensary, medical marijuana c ommercial grower or medical
110	110	marijuana processor shall not be an owner of a laboratory.
111	111	E. A laboratory and a l aboratory applicant sha ll comply with
112	112	all applicable local ordinances including , but not limited to,
113	113	zoning, occupancy, licensing and building co des.
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140	140	F. A separate license shall be required for each specific
141	141	laboratory.
142	142	G. A medical marijuana testing lab oratory license may b e issued
143	143	to a person who performs testin g on medical marijuana and medical
144	144	marijuana products for medical marijuana business es, medical
145	145	marijuana research facilities, medical marijuana educatio n
146	146	facilities, and testin g on marijuana and marijuana products g rown or
147	147	produced by a patient or caregiver on behalf of a patient, upon
148	148	verification of registration . A medical marijuana t esting
149	149	laboratory may also conduct research related to the developmen t and
150	150	improvement of its testing practices and procedures. No state-
151	151	approved medical marijuana testing facility shall operate unless a
152	152	medical laboratory director is on site during opera tional hours.
153	153	H. Laboratory applicants and licensees shall comply with the
154	154	application requirements of this se ction and shall submit such other
155	155	information as required for a medical marijuana business applicant,
156	156	in addition to any information the Authorit y may request for initial
157	157	approval and periodic evaluations during th e approval period.
158	158	I. A medical marijuana testing laboratory may accept samples of
159	159	medical marijuana, medical marijuana concentrate or medical
160	160	marijuana product from a medical marijuana business, medical
161	161	marijuana research facility or medical marijuana ed ucation facility
162	162	for testing purposes only, which purposes may include the provision
163	163	of testing services for samples submitted by a medical marijuana
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190	190	business for product development . The Department may require a
191	191	medical marijuana business to submit a sam ple of medical marijuana,
192	192	medical marijuana concentrate or medical marijuana product to a
193	193	medical marijuana testing or quality assurance laboratory upon
194	194	demand.
195	195	J. A medical marijuana te sting laboratory may accept samples of
196	196	medical marijuana, medical mar ijuana concentrate or medical
197	197	marijuana product from an individual person for testing only under
198	198	the following conditions:
199	199	1. The individual person is a patient or caregiver pursuant t o
200	200	the Oklahoma Medical Marijuana and Patient Protection Act or is a
201	201	participant in an approved clinical or observ ational study conducted
202	202	by a research facility; and
203	203	2. The medical marijuana testing laboratory shall require the
204	204	patient or caregiver to produc e a valid patient license and current
205	205	and valid photo identification.
206	206	K. A medical marijuana testing laborator y may transfer samples
207	207	to another medical marijuana testing laboratory for testing . All
208	208	laboratory reports provided to or by a medical marijuana business or
209	209	to a patient or caregiver shall identify the medical mar ijuana
210	210	testing laboratory that actually co nducted the test.
211	211	L. A medical marijuana testing laboratory may utilize a
212	212	licensed medical marijuana transporter to transport samples of
213	213	medical marijuana, medical marijuana concentrate and medical
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240	240	marijuana product for testing, in accordance wit h the Oklahoma
241	241	Medical Marijuana and Patient Protection Act and the rules adopted
242	242	pursuant thereto, between the originating medical marijuana business
243	243	requesting testing services and the destination laboratory
244	244	performing testing services.
245	245	M. The medical marijuana testing laboratory shall establish
246	246	policies to prevent the existence of or appearance of undue
247	247	commercial, financial or other influences that may diminish the
248	248	competency, impartiality and integrity of the testing p rocesses or
249	249	results of the laboratory, or that may diminish public confidence in
250	250	the competency, impartiality and integrity of the testing processes
251	251	or results of the laboratory . At a minimum, employees, owners or
252	252	agents of a medical marijuana testing lab oratory who participate in
253	253	any aspect of the analysis and results of a sample are prohibited
254	254	from improperly influencing the testing process, improperly
255	255	manipulating data or improperly be nefiting from any ongoing
256	256	financial, employment, personal or business relationship with the
257	257	medical marijuana business that provided the sample. A medical
258	258	marijuana testing laboratory shall not test samples for any medical
259	259	marijuana business in which an o wner, employee or agent of the
260	260	medical marijuana testing laboratory h as any form of ownership or
261	261	financial interest in the medical marijuana business.
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288	288	N. The Department, pursuant to rules promulgated by the State
289	289	Commissioner of Health, shall develop stan dards, policies and
290	290	procedures as necessary for:
291	291	1. The cleanliness and orderliness of a laboratory premises a nd
292	292	the location of the laboratory in a secure location, and inspection,
293	293	cleaning and maintenance of any equipment or utensils used for the
294	294	analysis of test samples;
295	295	2. Testing procedures, testing standards for can nabinoid and
296	296	terpenoid potency and safe le vels of contaminants, and remediation
297	297	procedures;
298	298	3. Controlled access areas for storage of medical marijuana and
299	299	medical marijuana product test samples, waste and reference
300	300	standards;
301	301	4. Records to be retained a nd computer systems to be utilized
302	302	by the laboratory;
303	303	5. The possession, storage and use by the laboratory of
304	304	reagents, solutions and reference standards;
305	305	6. A certificate of analysis ( COA) for each lot of reference
306	306	standard;
307	307	7. The transport and dispos al of unused marijuana, marijuana
308	308	products and waste;
309	309	8. The mandatory use by a laboratory of an inventory tracking
310	310	system to ensure all harvest and production batches or samples
311	311	containing medical marijuana, medical marijuana concentrate or
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338	338	medical marijuana products are identified and tracked f rom the point
339	339	they are transferred from a medical marijuana business, a patient or
340	340	a caregiver through the point of transfer, destruction or disp osal.
341	341	The inventory tracking system reporting shall include the resu lts of
342	342	any tests that are conducted on med ical marijuana, medical marijuana
343	343	concentrate or medical marijuana product;
344	344	9. Standards of performance;
345	345	10. The employment of laboratory perso nnel;
346	346	11. A written standard operating procedure manual to be
347	347	maintained and updated by the laboratory;
348	348	12. The successful participation in a Department -approved
349	349	proficiency testing program for each testing category listed in this
350	350	section, in order to ob tain and maintain certification;
351	351	13. The establishment of and adhere nce to a quality assurance
352	352	and quality control program to ensure sufficient monitoring of
353	353	laboratory processes and quality of results reported;
354	354	14. The immediate recall of medical mariju ana or medical
355	355	marijuana products that test above allowable threshold s or are
356	356	otherwise determined to be unsa fe;
357	357	15. The establishment by the laboratory of a system to document
358	358	the complete chain of custody for samples from receipt through
359	359	disposal;
360	360	16. The establishment by the laboratory of a system to retain
361	361	and maintain all required records , including business records, and
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388	388	processes to ensure results are reported in a timely and accurate
389	389	manner; and
390	390	17. Any other aspect of laboratory testing of medica l marijuana
391	391	or medical marijuana product deemed necessary by the Depa rtment.
392	392	O. A medical marijuana test ing laboratory shall promptly
393	393	provide the Department or designee of the Department access to a
394	394	report of a test and any underlying data that is conduct ed on a
395	395	sample at the request of a medical marijuana business or qual ified
396	396	patient. A medical marijuana testing laboratory shall also provide
397	397	access to the Department or designee of the Department to laboratory
398	398	premises and to any material or information requested by the
399	399	Department to determine compliance with the requirem ents of this
400	400	section.
401	401	P. A medical marijuana testing laboratory shall retain all
402	402	results of laboratory tests conducted on marijuana or products for a
403	403	period of at least seven (7) years and shall make them available to
404	404	the Department upon request.
405	405	Q. A medical marijuana testing laboratory shall test samples
406	406	from each harvest batch or product batch, as appropriate, of medical
407	407	marijuana, medical marijuana concentrate and medical marijuana
408	408	product for each of the following categories of testing, consistent
409	409	with standards developed by the Comm issioner:
410	410	1. Microbials;
411	411	2. Mycotoxins;
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438	438	3. Residual solvents;
439	439	4. Pesticides;
440	440	5. Tetrahydrocannabinol (THC) and other cannabinoid potency;
441	441	6. Terpenoid type and concentration ; and
442	442	7. Heavy metals.
443	443	R. A licensed medical marijuana testing laboratory shall test
444	444	each individual harvest batch . A grower shall separate each harvest
445	445	lot of usable marijuana into harvest batches containing no more tha n
446	446	fifteen (15) pounds, with the exception of any plant material to be
447	447	sold to a licensed processor for the purposes of turning the plant
448	448	material into concentrate which may be separated into harvest
449	449	batches of no more than fifty (50) pounds . A processor shall
450	450	separate each medical marijuana production lot into production
451	451	batches containing no more tha n four (4) liters of concentrate or
452	452	nine (9) pounds for nonliquid products, and for final products, the
453	453	Oklahoma Medical Marijuana Authority shall be authorized to
454	454	promulgate rules on final products as necessary . Provided, however,
455	455	the Authority shall not req uire testing of final products less often
456	456	than every one thousand (1,000) grams of THC. As used in this
457	457	subsection, "final products" shall include, but not be l imited to,
458	458	cookies, brownies, candies, gummies, beverages and chocola tes.
459	459	S. Medical marijuana testing laboratory licensure shall be
460	460	contingent upon successful on -site inspection, successful
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487	487	participation in proficiency testing and ongoing compliance with the
488	488	applicable requirements in this section.
489	489	T. A medical marijuana testing laboratory shal l be inspected
490	490	prior to initial licensure an d up to two (2) times per year
491	491	thereafter by an inspector approved by the Authority . The Authority
492	492	may enter the licensed premises of a testing laboratory to conduct
493	493	investigations and ad ditional inspections whe n the Authority
494	494	believes an investigation or additional inspection is necessary due
495	495	to a possible violation of applicable laws, rules or regulations.
496	496	U. Medical marijuana testing laboratories shall obtain
497	497	accreditation by an accrediting body approved by the Commissioner
498	498	within one (1) year of the date the initial license is issued .
499	499	Renewal of any medical marijuana testing laboratory license shall be
500	500	contingent upon accreditation in accordance with this subsection .
501	501	All medical marijuana testing laborator ies shall obtain
502	502	accreditation prior to applying for and receiving a medical
503	503	marijuana testing laboratory license .
504	504	V. Unless authorized by the provisions of this s ection, a
505	505	commercial grower shall not transfer or sell medical mariju ana and a
506	506	processor shall not transfer, se ll or process into a concentrate or
507	507	product any medical marijuana, medical marijuana concentrate or
508	508	medical marijuana product unless samples from each harvest batch or
509	509	production batch from which that medical marij uana, medical
510	510	marijuana concentrate or med ical marijuana product was derived has
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537	537	been tested by a medical marijuana testin g laboratory and passed all
538	538	contaminant tests required b y the Oklahoma Medical Marijuana and
539	539	Patient Protection Act and applicable law s, rules and regulatio ns.
540	540	A licensed commercial grower may transfer medical marijuana that has
541	541	failed testing to a licensed processor only for the purposes of
542	542	decontamination or remediat ion and only in accordance with the
543	543	provisions of the Oklahoma Medica l Marijuana and Patien t Protection
544	544	Act and the rules and regulations of the Department . Remediated and
545	545	decontaminated medical marijuana may be returned only to the
546	546	originating licensed c ommercial grower.
547	547	W. Beginning November 1, 2022, a licensed medical marijuana
548	548	commercial grower shall submit annually to the Authority the
549	549	business name, business address, and business license identification
550	550	number of every licensed medical marijuana testing laboratory that
551	551	the commercial grower contracts with to conduct contamination tests
552	552	on samples of its harvest batches. Licensed medical marijuana
553	553	commercial growers shall be required to notify the Authority within
554	554	ten (10) days of utilizing the services of a different licensed
555	555	medical marijuana testing laboratory.
556	556	X. Kief shall not be transferred or sold except as authorized
557	557	in the rules and regulations o f the Department.
558	558	SECTION 2. This act shall become effective November 1, 2022.
559	559
560	560	58-2-9910 GRS 01/04/22

Oklahoma 2022 Regular Session

Oklahoma House Bill HB4416 Compare Versions