5 Colo. Code Regs. § 1005-5-4

Current through Register Vol. 47, No. 11, June 10, 2024

Rule 5 CCR 1005-5-4 - Hemp Testing Laboratories: Certification Requirements

4.1Certification Category. For required tests, the Hemp Testing Laboratory must be certified by the Department in the category in order to perform that type of testing.

4.1.1 Residual solvents;

4.1.2 Microbials;

4.1.3 Mycotoxins;

4.1.4 Pesticides;

4.1.5 THC and other Cannabinoid potency;

4.1.6 Metals; and

4.1.7 Moisture content; and

4.1.8 Other required regulatory compliance testing.

4.2Certification Procedures and Principles. The Hemp Testing Laboratory certification program is contingent upon successful on-site inspection, successful participation in proficiency testing, and ongoing compliance with the requirements in this Rule.

4.2.1Certification Inspection. A Hemp Testing Laboratory must be inspected prior to initial certification and annually thereafter by the Department.

4.2.2Standards for Certification. A Hemp Testing Laboratory must meet standards of performance, as established by these rules, in order to obtain and maintain certification. Standards of performance include but are not limited to: Personnel Qualifications, Standard Operating Procedures, analytical processes, Proficiency Testing, Quality Control, quality assurance, security, Chain of Custody, Sample retention, Sample disposal, space, records, and results reporting.

4.2.2.1 A Hemp Testing Laboratory must be accredited under the International Organization for Standardization/International Electrotechnical Commission 17025:2017 Standard (ISO/IEC 17025), or any subsequent superseding ISO/IEC 17025 standard, by an accreditation body that is a signatory to the International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA). In order to obtain and maintain certification in a testing category from the Department, the Hemp Testing Laboratory's Scope of Accreditation must specify that particular testing category, including the applicable methods and Analytes. In addition, Hemp Testing Laboratories must be registered with the United States Drug Enforcement Administration, if required by applicable federal regulations.

4.2.2.2 Certification will be granted when laboratories have met all certification Requirements, including ISO/IEC 17025 accreditation.

4.2.2.3 The Department may grant provisional certification for a testing category if the laboratory has not yet obtained ISO/IEC 17025 accreditation but meets all other certification requirements. Such provisional certification shall be for a period not to exceed twelve months.

4.2.3Personnel Qualifications.

4.2.3.1Laboratory Director. A Hemp Testing Laboratory must employ, at a minimum, a laboratory director with sufficient education and experience in a regulated laboratory environment in order to obtain and maintain certification. See Rule 5 - Hemp Testing Laboratories: Personnel.

4.2.3.2Employee Competency. A Hemp Testing Laboratory must have a written and documented system to evaluate and document the competency of employees in performing authorized tests Prior to independently analyzing Samples, testing personnel must demonstrate acceptable performance on precision, accuracy, specificity, reportable ranges, blanks, and unknown challenge Samples (proficiency Samples or internally generated quality controls). Analysts must, at a minimum, annually (or upon method modification) demonstrate continued acceptable competency.

4.2.4Standard Operating Procedures. A Hemp Testing Laboratory must have written Standard Operating Procedures meeting the minimum standards set forth in these rules detailing the performance of all methods employed by the facility used to test the Analytes it reports and made available for testing analysts to follow at all times.

4.2.4.1 The current laboratory director must approve, sign and date each procedure. If any modifications are made to those procedures, the laboratory director must approve, sign, and date the revised version prior to use.

4.2.4.2 A Hemp Testing Laboratory must maintain a copy of all Standard Operating Procedures to include any revised copies for a minimum of three years. See Rule 12 - Hemp Testing Laboratories: Records Retention and Rule 13 - Hemp Testing Laboratories: Business Records Required.

4.2.4.3 A Hemp Testing Laboratory must inform the Department of any major changes to Standard Operating Procedures pertaining to analytical methods subsequent to initial certification. Major method changes include, but are not limited to: modifications to Sample preparation, changes in column type, changes in enrichment media, changes in solvent(s) used, etc.

4.2.5Analytical Processes. A Hemp Testing Laboratory must maintain a listing of all analytical methods used and all Analytes tested and reported. The Hemp Testing Laboratory must provide this listing to the Department upon request.

4.2.6Proficiency Testing. A Hemp Testing Laboratory must successfully participate in a Department approved Proficiency Testing program in order to obtain and maintain certification.

4.2.7Quality Assurance and Quality Control. A Hemp Testing Laboratory must establish and follow a quality assurance and Quality Control program to ensure sufficient monitoring of laboratory processes and quality of results reported.

4.2.8Security. A Hemp Testing Laboratory must be located in a secure setting as to prevent unauthorized persons from gaining access to the testing and storage areas of the laboratory.

4.2.9Chain of Custody. A Hemp Testing Laboratory must establish a system to document the complete Chain of Custody for Samples from receipt through disposal.

4.2.10Space. A Hemp Testing Laboratory must be located in a fixed structure that provides adequate infrastructure to perform analysis in a safe and compliant manner consistent with federal, state, and local requirements.

4.2.11Records. A Hemp Testing Laboratory must establish a system to retain and maintain records for a period not less than three years. See Rules 12 - Hemp Testing Laboratory: Records Retention and Rule 13 - Hemp Testing Laboratories: Business Records Required.

4.2.12Results Reporting. A Hemp Testing Laboratory must establish processes to ensure results are reported in a timely and accurate manner. A Hemp Testing Laboratory's process may require that the Hemp Cultivator or Hemp Product Manufacturer remit payment for any test conducted by the laboratory prior to reporting results. A Hemp Testing Laboratory's process established under this subparagraph (12) must be maintained on the premises of the Hemp Testing Laboratory.

4.2.13Conduct While Seeking Certification. A Hemp Testing Laboratory, and its agents and employees, shall provide all documents and information required or requested by the Department and its employees in a timely, full, faithful, truthful, and fair manner.

5 CCR 1005-5-4

44 CR 06, March 25, 2021, effective 4/14/2021

46 CR 21, November 10, 2023, effective 12/15/2023