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53	53	STATE OF OKLAHOMA
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55	55	1st Session of the 58th Legislature (2021)
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57	57	SENATE BILL 174 By: Rader
58	58
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63	63	AS INTRODUCED
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65	65	An Act relating to medical marijuana; amend ing
66	66	Section 17, Chapter 11, O.S.L. 2019, as amended by
67	67	Section 4, Chapter 312, O.S.L. 2019 (63 O.S. Supp.
68	68	2020, Section 427.17) , which relates to m edical
69	69	marijuana testing laboratory license ; providing
70	70	qualifications for medical laboratory director;
71	71	clarifying language; and providing an effective da te.
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77	77	BE IT ENACTED BY THE PEOPLE O F THE STATE OF OKLAHOMA:
78	78	SECTION 1. AMENDATORY Section 17, Chapter 11, O.S.L.
79	79	2019, as amended by Section 4, Chapter 312, O.S.L. 2019 (63 O.S.
80	80	Supp. 2020, Section 427.17), is amended t o read as follows:
81	81	Section 427.17. A. There is hereby created a medical marijuana
82	82	testing laboratory license as a category of the medical marijuana
83	83	business license. The Authority is hereby enabled to monitor,
84	84	inspect and audit a licensed testing labora tory under this act.
85	85	B. The Authority is hereby au thorized to contract with a
86	86	private laboratory for the purpose of conducting compliance testing
87	87	of medical marijuana testing laboratories licensed in this state.
88	88	Any such laboratory under contract for com pliance testing shall be
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140	140	prohibited from conducting any other commercial medical marijuana
141	141	testing in this state.
142	142	C. The Authority shall have the authority to develop acceptable
143	143	testing and research practices , including but not limited to
144	144	testing, standards, quality control analysis, equipment
145	145	certification and calibration, and chemical identification and
146	146	substances used in bona fide research methods so long as it complies
147	147	with this act.
148	148	D. A person who is a direct b eneficial owner or an indirect
149	149	beneficial owner of a medical marijuana dispensary, medical
150	150	marijuana commercial grower, or medical marijuana processor shall
151	151	not be an owner of a laboratory.
152	152	E. A laboratory and a or laboratory applicant shall comply with
153	153	all applicable local ordinances, includi ng but not limited to
154	154	zoning, occupancy, licensing and building codes.
155	155	F. A separate license shall be required for each specific
156	156	laboratory.
157	157	G. A medical marijuana testing laboratory license may be issued
158	158	to a person who performs testing and research on medical marijuana
159	159	and medical marijuana products fo r medical marijuana businesses,
160	160	medical marijuana research facilities, medical marijuana education
161	161	facilities, and testing and research on marijuana and marijuana
162	162	products grown or produced by a patient or caregiver on behalf of a
163	163	patient, upon verificatio n of registration.
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215	215	H. No state-approved medical marijuana testing facility shall
216	216	operate unless a medical laboratory director is on site during
217	217	operational hours. A medical laboratory director must posse ss a
218	218	bachelor’s degree in the chemical, environment al, biological or
219	219	physical sciences or engineering, with at least a total of twenty-
220	220	four (24) college semester credit hours in chemistry or biology and
221	221	at least two (2) years of experience in the environme ntal analysis
222	222	of representative inorganic and organ ic analytes for which the
223	223	laboratory will be performing . A master’s degree or doctoral degree
224	224	in one of the above disciplines may be substituted for one (1) year
225	225	of experience.
226	226	H. I. A laboratory applicant shall comply with the application
227	227	requirements of this section and shall submit such other information
228	228	as required for a medical marijuana business applicant, in addition
229	229	to any information the Authority may request for initi al approval
230	230	and periodic evaluations during the approval period.
231	231	I. J. A medical marijuana testing laboratory may accept samples
232	232	of medical marijuana, medical marijuana concentrate or medical
233	233	marijuana product from a medical marijuana business for testing and
234	234	research purposes only, which purposes may include the provision of
235	235	testing services for samples submitted by a medic al marijuana
236	236	business for product development. The Department may require a
237	237	medical marijuana business to submit a sample of medical marijuana,
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289	289	medical marijuana concentrate or medical marijuana product to a
290	290	medical marijuana testing laboratory upon deman d.
291	291	J. K. A medical marijuana testing laboratory may accept samples
292	292	of medical marijuana, medical marijuana concentrate or medical
293	293	marijuana product from an individual person for testing only under
294	294	the following conditions:
295	295	1. The individual person is a p atient or caregiver pursuant to
296	296	this act or is a participant in an approved clinical or
297	297	observational study conducted by a research fa cility; and
298	298	2. The medical marijuana testing laboratory shall require the
299	299	patient or caregiver to produce a valid patient license and current
300	300	and valid photo identification.
301	301	K. L. A medical marijuana testing laboratory may transfer
302	302	samples to another med ical marijuana testin g laboratory for testing.
303	303	All laboratory reports provided to or by a medical marijuana
304	304	business or to a patient or caregiver shall identify the medical
305	305	marijuana testing laboratory that actually conducted the test.
306	306	L. M. A medical marijuana testing laborato ry may utilize a
307	307	licensed medical marijuana transporter to transport samples of
308	308	medical marijuana, medical marijuana concentrate and medical
309	309	marijuana product for testing, in accordance with this act and the
310	310	rules adopted pursuant t hereto, between the orig inating medical
311	311	marijuana business requesting testing s ervices and the destination
312	312	laboratory performing testing services.
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364	364	M. N. The medical marijuana testing laboratory shall establish
365	365	policies to prevent the existence of or appea rance of undue
366	366	commercial, financial or other influences that may diminish the
367	367	competency, impartiality and integrity of t he testing processes or
368	368	results of the laboratory, or that may diminish public confidence in
369	369	the competency, impartiality and integrit y of the testing processes
370	370	or results of the laboratory. At a minimum, employe es, owners or
371	371	agents of a medical marijuana testing laboratory who participate in
372	372	any aspect of the analysis and results of a sample are prohibited
373	373	from improperly influencing t he testing process, imprope rly
374	374	manipulating data, or improperly benefiting from any ongoing
375	375	financial, employment, persona l or business relationship with the
376	376	medical marijuana business that provided the sample.
377	377	N. O. The Department, pursuant to rules prom ulgated by the
378	378	State Commissioner of Health, shall develop standards, policies and
379	379	procedures as necessary for:
380	380	1. The cleanliness and orderliness of a laboratory premises and
381	381	the location of the laboratory in a secure location, and inspection,
382	382	cleaning and maintenance of any equipm ent or utensils used for the
383	383	analysis of test sampl es;
384	384	2. Testing procedures, testing standar ds for cannabinoid and
385	385	terpenoid potency and safe levels of contaminants, and remediation
386	386	procedures;
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438	438	3. Controlled access areas for storage of medical marijuana and
439	439	medical marijuana product test samples, waste and reference
440	440	standards;
441	441	4. Records to be retained and computer systems to be utilized
442	442	by the laboratory;
443	443	5. The possession, storage and use by the laboratory of
444	444	reagents, solutions and reference standar ds;
445	445	6. A certificate of analysis (COA) for each lo t of reference
446	446	standard;
447	447	7. The transport and disposal of unused marijuana, marijuana
448	448	products and waste;
449	449	8. The mandatory use by a laboratory of an inventory tracking
450	450	system to ensure all test batches o r samples containing medical
451	451	marijuana, medical mar ijuana concentrate or medical marijuana
452	452	products are identified and tracked from the point they are
453	453	transferred from a medical marijuana business, a patient or a
454	454	caregiver through the point of transfer, de struction or disposal.
455	455	The inventory tracking syst em reporting shall include the results of
456	456	any tests that are conducted on medical marijuana, medical marijuana
457	457	concentrate or medical marijuana product;
458	458	9. Standards of perform ance;
459	459	10. The employment of laboratory personnel;
460	460	11. A written standard oper ating procedure manual to be
461	461	maintained and updated by the laboratory;
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513	513	12. The successful participation in a Department -approved
514	514	proficiency testing program for each testing ca tegory listed in this
515	515	section, in order to obtain and maintain certification;
516	516	13. The establishment of and adherence to a quality assurance
517	517	and quality control program to ensure sufficient monitoring of
518	518	laboratory processes and quality of results reported ;
519	519	14. The establishment by the laboratory of a system to document
520	520	the complete chain of custody for samples from receipt through
521	521	disposal;
522	522	15. The establishment by the laboratory of a system to retain
523	523	and maintain all required records, including business records, and
524	524	processes to ensure results are reported in a timely and accurate
525	525	manner; and
526	526	16. Any other aspect of labor atory testing of medical marijuana
527	527	or medical marijuana product deemed necessary by the Department.
528	528	O. P. A medical marijuana testing laboratory shall promptly
529	529	provide the Department or designee of the Department access to a
530	530	report of a test and any under lying data that is conducted on a
531	531	sample at the request of a medical marijuana business or qualified
532	532	patient. A medical marijuana tes ting laboratory shall also p rovide
533	533	access to the Department or designee of the Department to laboratory
534	534	premises and to any material or information requested by the
535	535	Department to determine compliance with the requirements of this
536	536	section.
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588	588	P. Q. A medical marijuana testing laboratory shall retain all
589	589	results of laboratory tests condu cted on marijuana or products for a
590	590	period of at least two (2) years and shall make them available to
591	591	the Department upon request.
592	592	Q. R. A medical marijuana testing laboratory shall test samples
593	593	from each harvest batch or product batch, as appropriate, of medical
594	594	marijuana, medical marijuana conce ntrate and medical marijuana
595	595	product for each of the following categories of testing, consistent
596	596	with standards developed by the Commi ssioner:
597	597	1. Microbials;
598	598	2. Mycotoxins;
599	599	3. Residual solvents;
600	600	4. Pesticides;
601	601	5. Tetrahydrocannabinol (THC) and other c annabinoid potency;
602	602	6. Terpenoid potency; and
603	603	7. Heavy metals.
604	604	R. S. A test batch shall not exceed ten (10) pounds of usable
605	605	marijuana or medical marijuana pro duct, as appropriate. A grower
606	606	shall separate each harvest lot of usable marijuana into harve st
607	607	batches containing no more than ten (10) pounds. A processor shall
608	608	separate each medical marijuana production lot into production
609	609	batches containing no more t han ten (10) pounds.
610	610	S. T. Medical marijuana testi ng laboratory licensure shall be
611	611	contingent upon successful on-site inspection, successful
612	612
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663	663	participation in proficiency testing and ongoing compliance with the
664	664	applicable requirements in this section.
665	665	T. U. A medical marijuana testing laboratory shall be inspected
666	666	prior to initial licensure and an nually thereafter by an inspector
667	667	approved by the Authority.
668	668	U. V. Beginning on a date determined by the Commissioner, not
669	669	later than January 1, 2020, medical ma rijuana testing laborat ory
670	670	licensure shall be conti ngent upon accreditation by the NELAC
671	671	Institute (TNI), ANSI/ASQ National Accreditation Board or another
672	672	accrediting body approved by the Commissioner, and any applicable
673	673	standards as determined by the Depa rtment.
674	674	V. W. A commercial grower shall not transf er or sell medical
675	675	marijuana and a processo r shall not transfer, sell or process into a
676	676	concentrate or product any medical marijuana, medical marijuana
677	677	concentrate or medical ma rijuana product unless sampl es from each
678	678	harvest batch or production batch from which that medical marijuana,
679	679	medical marijuana concentrate or medical marijuana product was
680	680	derived has been tested by a medical marijuana testing facility for
681	681	contaminants and passed all contaminant tes ts required by this act.
682	682	SECTION 2. This act shall become effective November 1, 2021.
683	683
684	684	58-1-928 DC 12/22/2020 11:13:00 AM

Oklahoma 2022 Regular Session

Oklahoma Senate Bill SB174 Compare Versions