Okla. Admin. Code § 442:10-8-6.3

Current through Vol. 42, No. 4, November 1, 2024

Section 442:10-8-6.3 - Laboratory standardization recommendations for sampling requirements and procedures

(a)Laboratory standardization recommendations. Beginning June 1, 2024, medical marijuana testing laboratories renewing their medical marijuana business license shall be subject to and comply with the following rules relating to the testing of medical marijuana, medical marijuana concentrate, and medical marijuana products. The refusal or failure of a medical marijuana testing laboratory licensee to comply with these rules relating to laboratory standards and testing procedures shall result in the permanent revocation of the medical marijuana testing laboratory license.

(b)General requirements. Samples must be collected, handled, stored, and disposed of in accordance with this Section. Individuals collecting samples are called "Samplers."

(1) Samplers shall:

(A) Follow the approved standard operating procedures of the laboratory that will be testing the samples collected;

(B) Be trained on how to collect samples in accordance with the standard operating procedures of the laboratory(ies) that will be conducting the testing on the samples collected;

(C) Have access to a copy of the laboratory's standard operating procedures while they are collecting the samples; and

(D) Follow inventory manifest requirements set forth in these Rules.

(2) Samplers shall collect samples at the location of the grower, processor or dispensary and must affix the samples with a tamper-proof seal at the time of collection.

(3) All commercial transporters, growers, processors or dispensaries transporting samples to a laboratory shall be prohibited from storing samples at any location other than the laboratory facility. All samples must be delivered the day of collection.

(4) For transfer or sale of harvest batches or production batches, samples must be collected in the final form. For purpose of this Subsection, "final form" means the form medical marijuana or a medical marijuana product is in when sold or transferred.

(5) The sampler shall collect both a primary sample and a reserve sample from each harvest batch and production batch. The sample shall be clearly and conspicuously labeled, and the label shall include at least the following information:

(A) Whether the sample is the "Primary Sample" or "Reserve Sample";

(B) The name and license number of grower, processor or dispensary from whom the sample was taken; and

(C) The batch number of the harvest batch or production batch from which the sample was taken.

(6) The primary sample and reserve sample shall be stored separately and analyzed separately. The reserve sample shall only be used for quality control purposes or for retesting in accordance with OAC 442:10-8-1(j).

(7) Samples shall be transported and subsequently stored at the laboratory in a manner that prevents degradation, contamination, and tampering. If the medical marijuana or medical marijuana product specifies on the label how the product shall be stored, the laboratory shall store the sample as indicated on the label.

(8) The sampler shall create and use a sample field log to record the following information for each sample, and copies of the sample field log shall be maintained by both the laboratory and the commercial licensee from which the samples are being collected. The field log shall include, at a minimum, the following information:

(A) Laboratory's name, address, and license number;

(B) Title and version of the laboratory's standard operating procedure(s) followed when collecting the sample;

(C) Sampler's name(s) and title(s);

(D) Date and time sampling started and ended;

(E) Grower's, processor's or dispensary's name, address, and license number;

(F) Batch number of the batch from which the sample was obtained;

(G) Sample matrix;

(H) Total batch size, by weight or unit count;

(I) Total weight or unit count of the primary sample;

(J) Total weight or unit count of the reserve sample;

(K) The unique sample identification number for each sample;

(L) Name, business address, and license number of the person who transports the samples to the laboratory;

(M) Requested analyses;

(N) Sampling conditions, including temperature;

(O) Problems encountered and corrective actions taken during the sampling process, if any; and

(P) Any other observations from sampling, including major inconsistencies in the medical marijuana color, size, or smell.

(9) The laboratory shall maintain inventory manifest documentation listed in OAC 442:10-3-6 and utilize an electronic inventory management system that meets the requirements set forth in OAC 442:10-5-6(d) for each sample that the laboratory collects, transports, and analyzes.

(10) Commercial licensees shall document all employee training on a testing laboratory's standard operating procedures.

(11) Commercial licensees must maintain the documentation required in these rules for at least seven (7) years and must provide that information to the Authority upon request.

(c)Sample size.

(1) To obtain a representative sample of a harvest batch, a total of one-half of one percent (0.5%) of the batch shall be collected from different areas of the batch following the laboratory's approved protocol. The sample shall then be homogenized and aliquoted into a primary sample and reserve sample. The primary sample and the reserve sample shall each weigh greater than or equal to seven grams (= 7 g). Any amounts left over after aliquoting may be returned to the harvest batch.

(2) To obtain a representative sample of a processed batch that is well mixed or homogeneous by its nature, a sampler shall obtain an amount sufficient to be aliquoted into a primary sample and a reserve sample, which shall be equal in amount. If the batch is not homogeneous or is of unknown homogeneity, then one-half of one percent (0.5%) of the batch shall be collected from different portions of the batch following the laboratory's approved protocol. The sample shall then be homogenized and aliquoted into a primary sample and reserve sample, which shall be equal in amount. The primary sample and reserve sample shall be in the amounts specified in the laboratory's standard operating procedure. Any amount left over after aliquoting may be returned to the production batch.

(3) To obtain a representative sample of a final medical marijuana product batch, samples shall be collected in accordance with the table in Appendix D.

(4) To obtain a representative sample of pre-rolls, samples shall be collected in accordance with the table in Appendix E.

(d)Sampling standard operating procedures.

(1) Samples collected must be representative of the entire batch to ensure accurate microbial analysis and foreign material assessments.

(2) Sampling protocol shall be approved by the laboratory director. The laboratory shall develop and implement written sampling policies and procedures that are appropriate for each test method and each type of matrix to be tested and that are consistent with these regulations. Sampling procedures must describe the laboratory's method for collection, preparation, packaging, labeling, documentation, and transport of samples from each matrix type the laboratory tests.

(3) The sampling standard operating procedures (SOP) shall include at least the following information:

(A) A step-by-step guide for obtaining samples from each matrix type the laboratory samples;

(B) Protocols for ensuring that contaminants are not introduced during sampling, including protocols relating to the sanitizing of equipment and tools, protective garb, and sampling containers;

(C) Accepted test sample types;

(D) Minimum test sample size;

(E) Recommended test sample containers;

(F) Test sample labeling;

(G) Transport and storage conditions, such as refrigeration, as appropriate to protect the physical and chemical integrity of the sample;

(H) Other requirements, such as use of preservatives, inert gas, or other measures designed to protect sample integrity; and

(I) Chain-of-custody documentation for each sample in accordance with OAC 442:10-5-6.

(4) The sampling SOP shall be signed and dated by the medical laboratory director and shall include any revision dates and authors. The laboratory director's signature denotes approval of the plan.

(5) The laboratory shall retain a controlled copy of the sampling SOP on the laboratory premises and ensure that the sampling SOP is accessible to the sampler in the field during sampling.

(e)Sample handling, storage and disposal. A laboratory shall establish sample handling procedures for the tracking of test samples through the analytical process (by weight, volume, number, or other appropriate measure) to prevent diversion.

(1) The laboratory shall not accept a test sample that is less than the minimum amount listed in OAC 442:10-8-3(b);

(2) The laboratory shall store each test sample under the appropriate conditions appropriate to protect the physical and chemical integrity of the sample;

(3) Analyzed test samples consisting of medical marijuana or medical marijuana products shall be held in a controlled access area pending destruction or other disposal;

(4) Reserve samples shall be maintained and properly stored by the laboratory for at least thirty (30) days; and

(5) After the required thirty (30) day storage period, any portion of a medical marijuana or medical marijuana product test sample that is not destroyed during analysis shall be:

(A) Returned to the licensed individual or entity that provided the sample after the required retention period for reserve samples;

(B) Transported to a state or local law enforcement office; or

(C) Disposed of in accordance with OAC 442:10-5-10 (relating to medical marijuana waste disposal).

(f)Data reporting.

(1) The laboratory shall generate a certificate of analysis (COA) for each sample that the laboratory analyzes.

(2) The laboratory shall issue the COA to the requester within two (2) business days after technical and administrative review of analysis has been completed. Any amendments to a COA shall include a revision identifier or report number, an explanation of the amendment, and shall identify all changes included in the amendment.

(3) All COAs, whether in paper or electronic form, shall contain, at minimum, the following information:

(A) The name, address, license number, and contact information of the laboratory that conducted the analysis;

(B) If the laboratory sends a sample to another laboratory for testing, the reference laboratory must be identified as having performed that test;

(C) The name, address, and license number of the requester;

(D) The description of the type or form of the test sample (leaf, flower, powder, oil, specific edible product, etc.) and its total primary sample weight in grams, reported to the nearest gram;

(E) The unique sample identifier;

(F) Batch number of the batch from which the sample was obtained;

(G) Sample history, including the date collected, the date received by the laboratory, and the date(s) of sample analyses and corresponding testing results, including units of measure where applicable;

(H) The analytical methods used, including at a minimum identification of the type of analytical equipment used (e.g., GC, HPLC, UV, etc.);

(I) The reporting limit for each analyte tested;

(J) Any compounds detected during the analyses of the sample that are not among the targeted analytes and are unknown, unidentified, tentatively identified or known and injurious to human health if consumed, if any;

(K) The identity of the supervisory or management personnel who reviewed and verified the data and results and ensured that data quality, calibration, and other applicable requirements were met;

(L) Definitions of any abbreviated terms; and

(M) The state inventory tracking system tag number, the sample tag number, and the source package tag number.

(4) The laboratory shall report test results for each primary sample on the COA as follows:

(A) When reporting quantitative results for each analyte, the laboratory shall use the appropriate units of measurement as required under this chapter and indicate "pass" or "fail";

(B) When reporting qualitative results for each analyte, the laboratory shall indicate "pass" or "fail";

(C) "Pass" and "Fail" must be clear, conspicuous, and easily identifiable in a font size no less than the size of 12 pt font in Times New Roman and shall not be in fine print or footnotes;

(D) When reporting results for any analytes that were detected below the analytical method limit of quantitation (LOQ), indicate "<LOQ" and list the results for analytes that were detected above the LOQ but below the allowable limit; and

(E) Indicate "NT" for not tested for any test that the laboratory did not perform.

(5) Upon detection of any compounds during the analyses of the sample that are not among the targeted analytes and are unknown, unidentified, tentatively identified, or known and injurious to human health if consumed, laboratories shall notify the Authority immediately and shall submit to the Authority a copy of the COA containing those compounds as required in OAC 442:10-8-3(e)(3)(I). The Authority may require a processor, grower, or dispensary to submit samples for additional testing, including testing for analytes that are not required by these Rules. The licensee shall provide the samples or units of medical marijuana or medical marijuana products at its own expense but shall not be responsible for the costs of testing.

(6) When a laboratory determines that a harvest batch or production batch has failed any required testing, the laboratory shall immediately notify the Authority in the manner and form prescribed by the Authority on its website and shall submit a copy of the COA to the Authority within two (2) business days. Submission of this information to the Authority through the State's inventory tracking system shall be sufficient to satisfy this reporting requirement.

Okla. Admin. Code § 442:10-8-6.3

Adopted by Oklahoma Register, Volume 41, Issue 3, October 16, 2023, eff. 9/11/2023, exp. 9/14/2024 (Emergency)

The adopted version of this section by Oklahoma Register, Volume 41, Issue 21, July 15, 2024, eff. 7/25/2024 is not yet available.