Laboratory Testing and Analysis Standards:
· Laboratory Functions
o Laboratory operations may conduct any analytical testing of cannabis, cannabis-derived products, hemp, or hemp-derived products.
o Analytical testing of cannabis or hemp may include, among other things, analysis for identity, purity and analysis of: heavy metals, microbiological organisms (e.g., total plate count, pathogens, yeasts, molds, etc.), microbial toxins, residues of pesticide or plant growth regulators, residual solvents, foreign matter, cannabinoid content, terpenoid content.
o Laboratory operations may utilize any appropriate tests and examinations in its analyses, including: gross organoleptic analysis, macroscopic analysis, microscopic analysis, chemical analysis, genetic (DNA) analysis or other scientifically valid methods.
· Personnel Must:
o Have education, training, and experience, or any combination thereof, to enable that person to perform all assigned functions.
o Have records of any training received for the performance of all assigned functions.
o Be provided instructions regarding regulatory inspection preparedness and law-enforcement interactions; and information on U.S. federal laws, regulations, and policies relating to individuals employed in these operations, and the implications of these for such employees.
o Laboratory operations must adhere to any regulation in the jurisdiction in which the operation is located including: locations and zoning, business hours, parking, drive-through services, signage
o Be maintained in a clean and orderly condition
o Processing and extracting operations must establish and adhere to such security procedures as are provided by applicable regulation in the jurisdiction in which this part applies.
o Provide security to protect the employees in a manner appropriate for the community
o Access to controlled Processing and extracting areas must be limited and controlled at all times
o There must be written procedures for security
· Sample receipt, handling and disposition
o Laboratory operations may receive test samples from any compliant business or compliant individual, or may be contracted to collect test samples on behalf of those entities
o Laboratory operations must establish and implement policies for collecting test samples in a manner that ensures that the sample accurately represents the material sampled
o Laboratory operations must record the receipt of each test sample, the date, individual responsible for delivery, statement of the quantity, a unique identifier of the sample
· Equipment and reagents
o Processing and extracting equipment must be adequately inspected, cleaned, and maintained.
o Reagents, solutions and reference standards must be: labeled to indicate identity, date received or prepared, date opened; stored under appropriate conditions and be within their expiration or requalification date at the time of use
o Laboratory operations may acquire commercial reference standards for cannabinoids
· Analysis of Samples must:
o Utilize analytical methods that are fit for cannabis testing purposes
o Require analysts to demonstrate proficiency in the performance of analytical methods used
o Ensure that no deviations from approved protocols or standard operating procedures are made during any analytical process without proper authorization and documentation
o Ensure that no deviations from approved protocols or standard operating procedures are made
o Ensure that all recording, review, storage and reporting of data is accurate, minimizes deterioration and prevents unauthorized alteration