A hemp testing laboratory (HTL) must meet compliance standards as established by the Colorado Department of Public Health and Environment Rule 5 CCR 1005-5 to analyze hemp products.
The HTL must complete any applicable local licensing prior to requesting certification. Marijuana testing facilities applying for HTL certification must also be currently licensed by the Colorado Marijuana Enforcement Division.
1. If applicable, complete all local licensing.
2. Request certification audit documents from CDPHE and perform self/internal audit inspections using checklists and correct all non-conformances.
The HTL will download the relevant documents from the list below. Alternatively, the HTL may email CDPHE (email@example.com) and request the certification audit documents. CDPHE will provide the HTL with any necessary documents including the inspection request form, on-site inspection checklists for self/internal audit, or any other relevant documents.
- Request for inspection form.
- General lab practices audit checklist (applicable to all testing categories).
- Metals audit checklist.
- Microbiology audit checklist.
- Moisture content audit checklist.
- Mycotoxins audit checklist.
- Pesticides audit checklist.
- Residual solvents audit checklist.
- Cannabinoid concentration audit checklist.
3. Submit a request for inspection to CDPHE, along with a quality assurance manual, standard of operations , and curriculum vitae.
After completing a self/internal audit using the audit checklists and correcting all non-conformances, the HTL will email the request for inspection form signed and dated by the laboratory director to CDPHE at firstname.lastname@example.org. In addition, the HTL will submit its self/internal audit and completed CDPHE audit checklists (completed checklists must provide the document or location where evidence of each requirement may be found), quality assurance manual, standard operating procedures , validation report, curriculum vitae/resumes for all staff, and copies of the ISO 17025 Scope of Accreditation and DEA registration, if available. Once received and accepted, an onsite inspection will be scheduled with the HTL.
Certified marijuana testing facilities applying for HTL certification will submit a verification study and associated standard operating procedures if the same testing methodologies are used for hemp and marijuana, as well as any standard operating procedures that deal specifically with industrial hemp (sample intake, reporting, etc.).
Certification categories: A HTL may only perform compliance testing in those categories for which they have been certified by CDPHE.
- Moisture content.
- Residual solvents.
- THC and other cannabinoid potency.
4. CDPHE on-site inspection and report.
CDPHE will inspect the HTL and evaluate documentation and lab practices to determine if standards of performance, as specified in the 5 CCR 1005-5, are met, including but not limited to: Personnel qualifications, standard operating procedure manuals, analytical processes, proficiency testing, quality control, quality assurance, security, sample tracking, specimen retention, laboratory space, records, and results reporting.
CDPHE will provide an inspection report to the HTL within 15 calendar days of completion of the onsite inspection process.
5. Provide a written plan of correction to CDPHE within 15 calendar days of receipt of the inspection.
When applicable, the HTL must provide a written plan of correction to CDPHE within 15 calendar days of receipt of the inspection report. Prior to initial certification, the HTL must provide evidence of correction of all deficiencies identified during the inspection as described by HTL in the plan of correction.
6. CDPHE reviews plan of correction and supporting documents to provide recommendations.
7. CDPHE issues certification.
CDPHE will issue initial or ongoing certification — provisional, conditional, or full — based upon approval of the plan of correction and compliance with all applicable requirements. The certification letter will list the approved categories of testing and the specified certification period, unless rescinded at the discretion of the CDPHE.
Onsite laboratory audit team
The CDPHE State Lab’s Cannabis Laboratory Certification Program will perform an annual on-site inspection using the Department’s subject matter expert(s).
Hemp testing laboratory (HTL) personnel
The HTL should have sufficient supervisory and other personnel, with the necessary education, training, technical knowledge, and experience for their assigned functions. The HTL must provide CDPHE with copies of all personnel qualifications, including the laboratory director, whenever initial certification or changes of personnel occur.
The laboratory director may delegate the responsibilities assigned under CDPHE rule to a qualified supervisory analyst, provided that such delegation is made in writing and a record of the delegation is maintained. Despite the designation of a responsibility, the laboratory director is responsible for ensuring that all duties are properly performed.
A HTL must have a written system to evaluate and document the competency of testing personnel to perform authorized tests. The HTL must establish and follow competency assessment policies. Competency assessments must occur and be documented for all analyst(s) prior to testing and reporting test results for hemp or hemp products for all approved methods used by the analyst(s), and annually thereafter. Competency assessment must occur and be documented for all analyst(s) whenever new methods are used, or changes to existing methods are made prior to testing and reporting results on hemp or hemp products.
Standard operating procedures
A HTL must have a written procedure manual meeting the minimum standards set forth in the rules detailing the performance of all methods employed by the laboratory to test the analytes it reports. This manual must be made available for testing analysts to follow at all times.
The current laboratory director must approve, sign, and date each standard operating procedure. If any modifications are made to those procedures, the laboratory director must approve, sign, and date the revised version prior to use.
A HTL must maintain a listing of all analytical methods being used and all analytes tested and reported. Copies of these methods must be made available upon request. CDPHE must be informed of any major changes to analytical methods prior to implementation.
A HTL must successfully participate in a CDPHE-approved proficiency testing (PT) program in order to obtain and maintain certification. Review the list of CDPHE approved proficiency testing providers for hemp testing.
Quality assurance and quality control
A HTL must establish and follow a quality assurance and quality control program to ensure sufficient monitoring of laboratory processes and the quality of results reported. Corrective actions taken by the HTL must be documented and reviewed on an ongoing basis by qualified personnel to evaluate the effectiveness of the corrective actions taken over time.
A HTL must be located in a secure setting to prevent unauthorized persons from gaining access to the testing and storage areas of the laboratory. The HTL must maintain a listing of all authorized personnel. The HTL must be in a fixed structure that provides adequate infrastructure to perform the analysis in a safe and compliant manner consistent with federal, state, and local requirements.
A HTL must establish a system to document complete sample tracking for samples from receipt through disposal. All testing of samples and aliquots must be tracked to include any samples sent to other CDPHE-certified hemp testing laboratories.
Result reporting and record retention
A HTL must establish a system to retain and maintain records for a minimum of three years, plus the current year. Retention of records includes but is not limited to: Personnel, standard operating procedures, test results to include instrument printouts, quality control and quality assurance records, chain of custody, and proficiency testing results.
A HTL must establish processes to ensure results are reported out within the HTL’s established turnaround times. All data required by rule must be reported, including measurement uncertainty, and quality control data must be reported upon client request.
HTL certification process fees
HTLs requesting an initial or annual on-site inspection by CDPHE will be invoiced for process fees (if applicable) found in the marijuana laboratory inspection section of the laboratory fee list.
Alternate contact: Candice Warren
University of Kentucky Hemp Proficiency Testing Program
Contact: Frank Sikora
Certification of hemp testing facilities: email@example.com