1 Colo. Code Regs. § 212-3-6-425

Current through Register Vol. 47, No. 16, August 25, 2024

Section 1 CCR 212-3-6-425 - Retail Marijuana Testing Facilities: Standard Operating Procedure Manual

Basis and Purpose - 6-425

The statutory authority for this rule includes but is not limited to sections 44-10-203(1)(c), 44-10-203(1)(k), 44-10-203(2)(d), 44-10-202(4), 44-10-401(2)(b)(IV), and 44-10-604, C.R.S. The purpose of this rule is to establish standard operating procedure manual standards for the operation of a Retail Marijuana Testing Facility. This Rule 6-425 was previously Rule R 705, 1 CCR 212-2.

A. A standard operating procedure manual must include, but need not be limited to, procedures for:

1. Test Batch receiving;

2. Test Batch accessioning;

3. Test Batch storage;

4. Identifying, rejecting, and reporting unacceptable Test Batches;

5. Recording and reporting discrepancies during Test Batch receiving an accessioning;

6. Security of Test Batches, aliquots and extracts and records;

7. Validating a new or revised method prior to testing of Test Batches to include: accuracy, precision, analytical sensitivity, analytical specificity (interferences), LOD, LOQ, and verification of the reportable range;

8. Test Batch preparation, including but not limited to, sub-sampling for testing, homogenization, and aliquoting Test Batches to avoid contamination and carry-over;

9. Test Batch archive retention to assure stability, as follows:

a. For Test Batches submitted for testing other than Pesticide contaminant testing, Test Batch retention for 14 days;

b. For Test Batch submitted for Pesticide contaminant testing, Test Batch retention for 90 days.

10. Disposal of Test Batches;

11. The theory and principles behind each assay;

12. Preparation and identification of reagents, standards, calibrators and controls and ensure all standards are traceable to National Institute of Standards of Technology ("NIST");

13. Special requirements and safety precautions involved in performing assays;

14. Frequency and number of control and calibration materials;

15. Recording and reporting assay results;

16. Protocol and criteria for accepting or rejecting analytical Procedure to verify the accuracy of the final report;

17. Pertinent literature references for each method;

18. Current step-by-step instructions with sufficient detail to perform the assay to include equipment operation and any abbreviated versions used by a testing analyst;

19. Acceptability criteria for the results of calibration standards and controls as well as between two aliquots or columns;

20. A documented system for reviewing the results of testing calibrators, controls, standards, and Test Batch results, as well as reviewing for clerical errors, analytical errors and any unusual analytical results and are corrective actions implemented and documented, and does the laboratory contact the requesting entity

21. Policies and procedures to follow when Test Batch are requested for referral and testing by another certified Retail Marijuana Testing Facility or an approved local or state agency's laboratory;

22. Testing Hemp, if the Retail Marijuana Testing Facility tests Hemp;

23. Investigating and documenting existing or potential Nonconformances and implementing Corrective Actions and/or Preventive Actions;

24. Contacting the requesting entity about existing Nonconformances; and

25. Retesting or additional analyses of Test Batches, including but need not be limited to, when it is appropriate to retest or perform an additional analysis of the Test Batch, when it is appropriate to request a new Test Batch from the requesting entity, and when it is appropriate for the requesting entity to request retesting (e.g., after failing Pesticide testing or elemental impurity testing on Regulated Marijuana flower, trim, shake, or wet whole plant as permitted by Rule 4-135(d) and 4-135(D.1));

B.Violation Affecting Public Safety. Failure to comply with this Rule may constitute a license violation affecting public safety.

1 CCR 212-3-6-425

42 CR 23, December 10, 2019, effective 1/1/2020

43 CR 21, November 10, 2020, effective 1/1/2021

44 CR 07, April 10, 2021, effective 5/1/2021

44 CR 13, July 10, 2021, effective 8/1/2021

44 CR 23, December 10, 2021, effective 1/1/2022

45 CR 21, November 10, 2022, effective 12/1/2022

46 CR 23, December 10, 2023, effective 1/8/2024