5 Colo. Code Regs. § 1005-7-1
Current through Register Vol. 47, No. 24, December 25, 2024
Rule 5 CCR 1005-7-1 - [Effective 1/14/2025] Authority and Definitions1.1 Authority This regulation is established under the authority contained in sections 25-1.5-120(1) and 25-1.5-101(1)(f), C.R.S.
1.2 Scope and Purpose The purpose of this rule is to establish criteria for natural medicine and natural medicine product testing and the certification of Natural Medicine Testing Facilities to perform this testing.
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 "Chain of Custody" (COC) means the chronological documentation that records the sequence of custody, control, transfer, analysis, and disposal of a Sample.1.3.6 "Corrective Action" means a reactive action implemented to eliminate the root cause of a Nonconformance and to prevent recurrence.1.3.7 "Certificate of Analysis" (COA) means an official document issued by a certified Natural Medicine Testing Facility that shows results of scientific tests performed on a product.1.3.8 "Certified Reference Material" (CRM) means a material characterized by a metrologically valid procedure for one or more specified properties, accompanied by a certificate issued by an authoritative body that provides the value of the specified property, its associated uncertainty, and a statement of metrological traceability.1.3.9 "Department" means the Colorado Department of Public Health and Environment.1.3.10 "Exclusivity" means the specificity of the test method for validating microbial and speciation testing methods. It evaluates the ability of the method to distinguish the Target Organisms from similar but genetically distinct non-target organisms.1.3.11 "Facilitator" means a natural person who is 21 years of age or older, has the necessary qualifications, training, experience, and knowledge to perform and supervise natural medicine services for a participant, and is licensed by the director of the division of professions and occupations to engage in the practice of facilitation.1.3.12 "Fruiting Body(ies)" means the spore producing organs of the fungi Psilocybe cubensis.1.3.13 "Harvest Lot" means a specifically identified quantity of Fruiting Bodies that is cultivated from the same inoculation, and dried under the same conditions and harvested in the same area within the licensed premises, that may be partially harvested; and, may use the substrate material for multiple harvests. A Harvest Lot must not contain more than 1.000 kilogram by dry weight.1.3.14 "Healing Center" means a facility where an entity is licensed by the State Licensing Authority pursuant to article 50 of title 44 that permits a Facilitator to provide and supervise natural medicine services for a participant.1.3.15 "Inclusivity" means, related to microbiological and speciation method validation, the sensitivity of the test method. Inclusivity evaluates the ability of the test method to detect a wide range of Target Organisms by a defined relatedness.1.3.16 "Instrument Detection Limit" (IDL) is the concentration equivalent of a signal, due to 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.1.3.17 "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 Natural Medicine Testing Facility certification, the LOD is approximately equal to the Method Detection Limit (MDL) for those tests in which the MDL can be calculated.
1.3.18 "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. 1.3.19 "Matrix" means the components of a Sample other than the Analyte(s) of interest (i.e., Sample type).1.3.21 "Moisture Content" means the percentage of water in a Sample, by weight.1.3.22 "Mycelium" means the fungal threads or hyphae of Psilocybe cubensis.1.3.23 "Natural Medicine Business" means any of the following entities licensed pursuant to the Natural Medicine Code: b. A Natural Medicine Cultivation Facility;c. A Natural Medicine Products Manufacturer; andd. A Natural Medicine Testing Facility.1.3.24 "Natural Medicine Code" means article 50 of title 55 of the Colorado Revised Statutes.1.3.25 "Natural Medicine Cultivation Facility" means a location where Regulated Natural Medicine is grown, harvested, and prepared in order to be transferred to either a Healing Center, Facilitator, Natural Medicine Products Manufacturer, or to another Natural Medicine Cultivation Facility.1.3.26 "Natural Medicine Products Manufacturer" means a person who manufactures Regulated Natural Medicine Products for transfer to a Healing Center, Facilitator, or to another Natural Medicine Products Manufacturer.1.3.27 "Natural Medicine Testing Facility" means a public or private laboratory licensed or approved by the Colorado Department of Revenue and certified by the Department to perform testing and research on Regulated Natural Medicine and Regulated Natural Medicine Product. 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 Natural Medicine Testing Facility's written Corrective Action and Preventive Action (CAPA) 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 or minimize the cause of a potential Nonconformance or other quality problem before it occurs.1.3.31 "Production Lot" means psilocybin pressed tablets, tea bags, chocolate, gelatin- or agar-based gummies, or powdered capsules of the same type that were manufactured under the same conditions at the same time using the same manufacturing method, ingredients, and standard operating procedures.1.3.32 "Proficiency Testing" means an assessment of the performance of a Natural Medicine Testing Facility'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.1.3.33 "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.1.3.34 "Regulated Natural Medicine" means natural medicine that is cultivated, manufactured, tested, stored, distributed, transported, transferred, or dispensed pursuant to the Natural Medicine Code. Regulated Natural Medicine includes:1.3.35 "Regulated Natural Medicine Product" means a natural medicine product that is cultivated, manufactured, tested, stored, distributed, transported, or dispensed pursuant to the Natural Medicine Code.1.3.36 "Reference Material" means material containing a known concentration of an Analyte of interest that is in solution or in a homogeneous Matrix.1.3.37 "Reference Method" means the method by which the performance of an alternate method is measured or evaluated.1.3.38 "Sample" means a composite of Sample Increments collected from the same Harvest Lot or Production Lot and submitted for testing.1.3.39 "Sample Increment" means a portion of Regulated Natural Medicine that is removed from a Harvest Lot or Regulated Natural Medicine Product that is removed from a Production Lot and combined into a Sample for required testing.1.3.40 "Scope of Accreditation" means the tests or types of tests performed, materials or products tested, and the methods used for testing Regulated Natural Medicine or Regulated Natural Medicine Products for which the Accreditation has been granted.1.3.41 "Standard Operating Procedure" (SOP) means a written document detailing instructions for the methods required to be followed for the routine performance of operations, analysis, or tasks. A SOP must include a clear and unique title, a purpose explaining the reason for the SOP and its scope. It must list all materials and equipment required to complete the procedure and provide definitions for any ambiguous, unclear or abbreviated terms. It must also delegate responsibilities by specifying individuals or job titles responsible for overseeing and completing the procedure. The procedure section must be a detailed step-by-step instruction dictating how and when an operation is routinely performed. Health and safety guidelines or protocols must be outlined. Any additional documents, forms, or references needed to complete the task or used to create the task must be included in an appendix or reference section. The SOP must also document all revisions and updates.1.3.42 "Target Organism" means an organism that is being tested for in an analytical procedure or test method.1.3.43 "Total psilocin" means psilocybin multiplied by 0.719 plus psilocin. Total Psilocin shall be expressed as a weight (i.e. mg Total Psilocin = (mg psilocybin x 0.719) + mg psilocin) or weight percent (i.e. % Total Psilocin = (% psilocybin x 0.719) + % psilocin).47 CR 24, December 25, 2024, effective 1/14/2025