Statutes, codes, and regulations
Colorado Administrative Code
Department 1000 - Department of AgricultureDivision 1005 - Division of Disease Dontrol and Public Health Response
Rule 5 CCR 1005-5 - HEMP TESTING LABORATORY CERTIFICATION
Rule 5 CCR 1005-5-1 - Authority and Definitions

5 Colo. Code Regs. § 1005-5-1

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Current through Register Vol. 47, No. 11, June 10, 2024
Rule 5 CCR 1005-5-1 - Authority and Definitions
1.1 Authority

This regulation is established under the authority contained in sections 35-61-105.5(2)(d) and 25-1.5-101(1)(f) et seq., C.R.S.

1.2 Scope and Purpose

The purpose of this rule is to establish criteria for the certification of laboratories to test Industrial Hemp and hemp-derived products.

1.3 Definitions

The following terms, whenever used in or referred to in these regulations, shall have the following respective meanings:

1.3.1 "Acceptability Criteria" means the specified limits placed on the characteristics of an item or method that are used to determine data quality.
1.3.2 "Accreditation" means approval by an impartial non-profit organization that operates in conformance with the International Organization for Standardization (ISO) / International Electrotechnical Commission (IEC) standard 17011 and is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) for Testing.
1.3.3 "Action Level" means the threshold value that provides the criterion for determining whether a Sample passes or fails an analytical test.
1.3.4 "Analyte" means the substance of interest in the analysis.
1.3.5 "Cannabinoid" means a class of lipophilic molecules that are naturally occurring in cannabis, including Hemp and marijuana.
1.3.6 "CBD" means cannabidiol.
1.3.7 "CBDA" means cannabidiolic acid.
1.3.8 "Chain of Custody" or "COC" means the chronological documentation that records the sequence of custody, control, transfer, analysis, and disposal of a Sample.
1.3.9 "Corrective Action" means a reactive action implemented to eliminate the root cause of a Nonconformance and to prevent recurrence.
1.3.10 "Certificate of Analysis" means an official document issued by a certified Hemp Testing Laboratory that shows results of scientific tests performed on a product.
1.3.11 "Delta-9 tetrahydrocannabinol" or "delta-9 THC" has the same meaning as "tetrahydrocannabinols" as set forth in section 27-80-203 (24). C.R.S. Delta-9 THC (CAS 1972-08-3) is the primary psychoactive component of cannabis. For the purposes of these regulations, the terms "Delta-9 THC" and "THC" are interchangeable.
1.3.12 "Department" means the Colorado Department of Public Health and Environment.
1.3.13 "Dry Weight Basis" means the ratio of the amount of moisture in a sample to the amount of dry solid in a sample. A basis for expressing the percentage of a chemical in a substance after removing the moisture from the substance. Percentage of THC on a dry weight basis means the percentage of THC, by weight, in a cannabis item (plant, extract, or other derivative), after excluding moisture from the item.
1.3.14 "Exclusivity" means the specificity of the test method for validating microbial testing methods. It evaluates the ability of the method to distinguish the Target Organisms from similar but genetically distinct non-target organisms.
1.3.15 "Hemp Testing Laboratory" means a public or private laboratory certified, or approved by the Department, to perform compliance testing on Hemp and Hemp Products.
1.3.16 "Inclusivity" means, related to microbiological method validation, the sensitivity of the test method. It evaluates the ability of the test method to detect a wide range of Target Organisms by a defined relatedness.
1.3.17 "Hemp" or "hemp" means the plant Cannabis sativa L. and any part of the plant, Including the seeds, all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a Delta-9 tetrahydrocannabinol concentration of no more than 0.3% on a dry-weight basis.
1.3.18 "Hemp Cultivator" means a producer that grows Hemp undercurrent registration issued by the Colorado Department of Agriculture.
1.3.19 "Hemp Extract" means an unfinished hemp product or hemp product produced through a solvent or non-solvent based hemp manufacturing process, including but not limited to oils, distillates, resins, and isolates.
1.3.20 "Hemp Manufacturer" means a facility where hemp products are manufactured or stored under a current registration issued by the Colorado Department of Public Health and Environment.
1.3.21 "Hemp Product" means a finished product that contains Hemp and that:
a. Is a cosmetic, a dietary supplement, a food, a food additive, or an herb;
b. Is intended for human use or consumption;
c. Contains any part of the hemp plant, including naturally occurring Cannabinoids, compounds, concentrates, extracts, isolates, resins;
d. Is produced from hemp;
e. Contains no more than 1.75 milligrams of THC per serving; and
f. Contains a ratio of cannabidiol to THC of greater than or equal to 15:1.
1.3.22 "Instrument Detection Limit" (IDL) is the concentration equivalent to a signal, due the analyte of interest, which is the smallest signal that can be distinguished from background noise by a particular instrument. The IDL should always be below the method detection limit, and is not used for compliance data reporting, but may be used for statistical data analysis and comparing the attributes of different instruments. The IDL is similar to the "critical level" and "criterion of detection" as defined in the literature.
1.3.23 "Limit of Detection" (LOD) or detection limit, is the lowest concentration level that can be determined to be statistically different from a blank (99% confidence). The LOD is typically determined to be in the region where the signal to noise ratio is greater than 5. Limits of detection are matrix, method, and analyte specific.

Note: For the purposes of laboratory certification, the LOD is approximately equal to the Method Detection Limit (MDL) for those tests in which the MDL can be calculated.

1.3.24 "Limit of Quantitation" (LOQ), or lower limit of quantitation (LOQ), is the level above which quantitative results may be obtained with a specified degree of confidence. The LOQ is mathematically defined as equal to 10 times the standard deviation of the results for a series of replicates used to determine a justifiable limit of detection. Limits of quantitation are matrix, method, and analyte specific.
1.3.25 "Matrix" means the components of a Sample other than the Analyte(s) of interest (i.e., Sample type).
1.3.26 "Measurement Uncertainty" is defined as a parameter, associated with the result of a measurement, that characterizes the dispersion of the values that could reasonably be attributed to the measurand. The following equation is recommended:

Equation:

Click to view image

Click to view image

1.3.27 "Moisture Content" means the percentage of water in a Sample, by weight.
1.3.28 "Nonconformance" means a non-fulfillment of a requirement or departure from written procedures, work instructions, or quality system, as defined by the laboratory's written Corrective Action and Preventive Action procedures.
1.3.29 "Person" means a natural person, an estate, a trust, an Entity, or a state or other jurisdiction.
1.3.30 "Preventive Action" means a proactive action implemented to eliminate the cause of a potential Nonconformance or other quality problem before it occurs.
1.3.31 "Proficiency Testing" means an assessment of the performance of a Hemp Testing Laboratory's methodology and processes. Proficiency Testing is also known as inter laboratory comparison. The goal of Proficiency Testing is to ensure results are accurate, reproducible, and consistent.
1.3.32 "Quality Control" means the set of measures implemented within an analytical procedure to ensure that the measurement system is operating in a state of statistical control for which errors have been reduced to acceptable levels.
1.3.33 "Reference Material" means material containing a known concentration of an Analyte of interest that is in solution or in a homogeneous Matrix.
1.3.34 "Reference Method" means the method by which the performance of an alternate method is measured or evaluated.
1.3.35 "Sample" means the Hemp, Hemp Product or Unfinished Hemp Product submitted to a Hemp Testing Laboratory for compliance testing required by the Department or the Colorado Department of Agriculture.
1.3.36 "Scope of Accreditation" means the tests or types of tests performed, materials or products tested, and the methods used for testing cannabis or cannabis products for which the accreditation has been granted.
1.3.37 "Standard Operating Procedure" (SOP) means a written document that provides detailed instructions for the performance of all aspects of an analysis, operation, or action.
1.3.38 "Target Organism" means an organism that is being tested for in an analytical procedure or test method.
1.3.39 For purposes of testing hemp, "THC" means delta-9-tetrahydrocannabinol.
1.3.40 For purposes of testing hemp products, "THC" means the substance contained in the plant cannabis species, in the resinous extracts of the cannabis species, or a carboxylic acid of, derivative of, salt of, isomer of,or salt or acid of an isomer of these substances. "Tetrahydrocannabinol" or "THC" includes:
A. DELTA-10 THC and its isomers;
B. DELTA-9 THC and its isomers;
C. DELTA-8 THC and its isomers;
D. DELTA-7 THC and its isomers;
E. DELTA-6A, 10A THC and its isomers; and
F. EXO-TETRAHYDROCANNABINOL;

"TETRAHYDROCANNABINOL" OR "THC" may also contain:

A. products of any of the compounds listed in subsections (a) to (f) of this section; or
B. metabolites of any of the compounds listed in subsections (a) to (f) of this section.
1.3.41 "THCA" means DELTA-9 tetrahydrocannabinolic acid.
1.3.42 "Total CBD" means the sum of the percentage by weight of CBDA multiplied by 0.877 plus the percentage by weight of CBD i.e., Total CBD= (%CBDA x 0.877) + %CBD.
1.3.43 For purposes of testing hemp, "Total THC" means the sum of the percentage by weight of THCA multiplied by 0.877 plus the percentage by weight of THC i.e., Total THC = (%THCA x 0.877) + %THC.
1.3.44 "Unfinished Hemp Product" means an oil, concentrate or other substance that has a total THC concentration above 0.3% and less than or equal to 5.0%, is not for consumer use or distribution, must be sold or transferred between registered manufacturers, and will undergo further refinement or processing into ahemp product.

5 CCR 1005-5-1

44 CR 06, March 25, 2021, effective 4/14/2021
46 CR 21, November 10, 2023, effective 12/15/2023