1 Colo. Code Regs. § 212-3-6-430

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

Section 1 CCR 212-3-6-430 - Retail Marijuana Testing Facilities: Analytical Processes

Basis and Purpose - 6-430

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 analytical processes standards for the operation of a Retail Marijuana Testing Facility. This Rule 6-430 was previously Rule R 706, 1 CCR 212-2.

A.Gas Chromatography ("GC"). A Retail Marijuana Testing Facility using GC must:

1. Document the conditions of the gas chromatograph, including the detector response;

2. Perform and document preventive maintenance as required by the manufacturer;

3. Ensure that records are maintained and readily available to the staff operating the equipment;

4. Document the performance of new columns before use;

5. Use an internal standard for each qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified;

6. Establish criteria of acceptability for variances between different aliquots and different columns; and

7. Document the monitoring of the response (area or peak height) of the internal standard to ensure consistency overtime of the analytical system.

B.Gas Chromatography Mass Spectrometry ("GC/MS"). A Retail Marijuana Testing Facility using GC/MS must:

1. Perform and document preventive maintenance as required by the manufacturer;

2. Document the changes of septa as specified in the standard operating procedure;

3. Document liners being cleaned or replaced as specified in the standard operating procedure;

4. Ensure that records are maintained and readily available to the staff operating the equipment;

5. Maintain records of mass spectrometric tuning;

6. Establish written criteria for an acceptable mass-spectrometric tune;

7. Document corrective actions if a mass-spectrometric tune is unacceptable;

8. Monitor analytic analyses to check for contamination and carry-over;

9. Use selected ion monitoring within each run to assure that the laboratory compares ion ratios and retention times between calibrators, controls and samples for identification of an analyte;

10. Use an internal standard for qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified and is isotopically labeled when available or appropriate for the assay;

11. Document the monitoring of the response (area or peak height) for the internal standard to ensure consistency overtime of the analytical system;

12. Define the criteria for designating qualitative results as positive;

13. When a library is used to qualitatively identify an analyte, the identity of the analyte must be confirmed before reporting results by comparing the relative retention time and mass spectrum to that of a known standard or control run on the same system; and

14. Evaluate the performance of the instrument after routine and preventive maintenance (e.g. clipping or replacing the column or cleaning the source) prior to analyzing subject samples.

C.Immunoassays. A Retail Marijuana Testing Facility using Immunoassays must:

1. Perform and document preventive maintenance as required by the manufacturer;

2. Ensure that records are maintained and readily available to the staff operating the equipment;

3. Validate any changes or modifications to a manufacturer's approved assays or testing methods when a sample is not included within the types of samples approved by the manufacturer; and

4. Define acceptable separation or measurement units (absorbance intensity or counts per minute) for each assay, which must be consistent with manufacturer's instructions.

D.Thin Layer Chromatography ("TLC"). A Retail Marijuana Testing Facility using TLC must:

1. Apply unextracted standards to each thin layer chromatographic plate;

2. Include in their written procedure the preparation of mixed solvent systems, spray reagents and designation of lifetime;

3. Include in their written procedure the storage of unused thin layer chromatographic plates;

4. Evaluate, establish, and document acceptable performance for new thin layer chromatographic plates before placing them into service;

5. Verify that the spotting technique used precludes the possibility of contamination and carry-over;

6. Measure all appropriate RF values for qualitative identification purposes;

7. Use and record sequential color reactions, when applicable;

8. Maintain records of thin layer chromatographic plates; and

9. Analyze an appropriate matrix blank with each batch of Samples analyzed.

E.High Performance Liquid Chromatography ("HPLC"). A Retail Marijuana Testing Facility using HPLC must:

1. Perform and document preventive maintenance as required by the manufacturer;

2. Ensure that records are maintained and readily available to the staff operating the equipment;

3. Monitor and document the performance of the HPLC instrument each day of testing;

4. Evaluate the performance of new columns before use;

5. Create written standards for acceptability when eluting solvents are recycled;

6. Use an internal standard for each qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified when available or appropriate for the assay; and

7. Document the monitoring of the response (area or peak height) of the internal standard to ensure consistency overtime of the analytical system.

F.Liquid Chromatography Mass Spectroscopy ("LC/MS"). A Retail Marijuana Testing Facility using LC/MS must:

1. Perform and document preventive maintenance as required by the manufacturer;

2. Ensure that records are maintained and readily available to the staff operating the equipment;

3. Maintain records of mass spectrometric tuning;

4. Document corrective actions if a mass-spectrometric tune is unacceptable;

5. Use an internal standard with each qualitative and quantitative analysis that has similar chemical and physical properties to that of the compound identified and is isotopically labeled when available or appropriate for the assay;

6. Document the monitoring of the response (area or peak height) of the internal standard to ensure consistency overtime of the analytical system;

7. Compare two transitions and retention times between calibrators, controls and samples within each run;

8. Document and maintain records when changes in source, source conditions, eluent, or column are made to the instrument; and

9. Evaluate the performance of the instrument when changes in: source, source conditions, eluent, or column are made prior to reporting test results.

G.Microbial Assays. A Retail Marijuana Testing Facility using microbial assays must:

1. Perform and document preventive maintenance as required by the manufacturer and standard operating procedures;

2. Ensure that records are maintained and readily available to the staff operating the equipment;

3. Validate any changes or modifications to a manufacturer's approved assays or testing methods when a test sample is not included within the types of Test Batches approved by the manufacturer;

4. Verify the method at the action levels for each analyte. Verification at the qualitative presence/absence limit shall include a fractional recovery study unless otherwise completed by the manufacturer and approved by an independent scientific body.

5. Include controls for each batch of test samples. Quantitative microbial methods shall use controls of a specific known value or set of values that lies within the quantifiable range of the method;

6. For molecular methods, the Retail Marijuana Testing Facility shall include controls for each individual analytical run. Quantitative molecular methods shall use controls of a specific known value or set of values that lies within the quantifiable range of the method;

7. PCR-based and qPCR-based methods must include validated internal amplification controls;

8. Microbial methods must include steps to confirm presumptive positive results; confirmation methods may be molecular or cultural or both. Confirmation methods must include quality controls that match the organism which is being confirmed.

H.Water Activity. A Retail Marijuana Testing Facility analyzing water activity must:

1. Perform and document preventive maintenance as required by the manufacturer and standard operating procedures;

2. Ensure that records are maintained and readily available to the staff operating the equipment;

3. Specify all unique method parameters, such as temperature, sample surface area, volatile compound interferences, including but not limited to temperature;

4. Evaluate the performance of the method after routine and preventive maintenance prior to analyzing the Test Batch;

5. Establish criteria for acceptable instrument performance.

I.Analytical Methodology. A Retail Marijuana Testing Facility must validate new methodology and revalidate any changes to approved methodology prior to testing Test Batches. A Retail Marijuana Testing Facility must:

1. Implement a performance based measurement system for the selected methodology and validate the method following good laboratory practices prior to reporting results. Validation of other or new methodology must include when applicable, but is not limited to:

a. Verification of Accuracy

b. Verification of Precision

c. Verification of Analytical Sensitivity

d. Verification of Analytical Specificity

e. Verification of the LOD

f. Verification of the LOQ

g. Verification of the Reportable Range

h. Identification of Interfering Substances

2. Validation of the other or new methodology must be documented.

3. Prior to use, other or new methodology must have a standard operating procedure approved and signed by the laboratory director.

4. Testing analysts must have documentation of competency assessment prior to testing Test Batches.

5. Any changes to the approved other or new methodology must be revalidated and documented prior to testing Test Batches.

J.Testing Validation of Complex Matrices. A Retail Marijuana Testing Facility must include a variety of matrices as part of the validation/verification process. During method validation/verification, a Retail Marijuana Testing Facility must:

1. Select matrices which best represent each category of products to be tested as listed in Rule 4-115(D). The laboratory shall independently determine the category of matrix a product falls within; properties to consider include fat content, cannabinoid content, pH, salt content, sugar content, water activity, the presence of know chemical compounds, microbial flora and antimicrobial compounds.

2. Perform a new matrix validation, prior to reporting results, on matrices which are either A) a new category of matrix or B) considerably different from the original matrix validated within the category.

a. For example, the Retail Marijuana Testing Facility intends to receive the topical product "bath bombs" for testing, but previous validation studies for topical product included lotion and massage oil. A new validation should be performed for the product prior to testing since salt content and other properties differ vastly from the original matrices validated.

3. Perform a matrix verification (a client matrix spike or similar consisting of the target analyte(s) at the time of analysis) on matrices submitted for testing which differ slightly from those initially validated but which fall within a category already validated.

a. For example, the Retail Marijuana Testing Facility receives a new edible type matrix for testing (snickerdoodle cookies) but previous validation included gummies and hard candy. A spike of a portion of the submitted material must be analyzed prior to, or at the time of, sample analysis.

K. All Test Batches and Hemp Product must be tested as received, must not be manipulated, and tested in a manner that ensures results are representative of sample as received.

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

1 CCR 212-3-6-430

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