1. The process is not clear as to how the BoP will assure that laboratories conduct appropriate analyses. Typically, laboratories must adhere to an accreditation expectation when responsible for analyses that impact public health and safety. 

2. Paragraph 2: Qualifications for director level person. Suggest language change to be:

Has employed at least one person to oversee and be responsible for the laboratory testing who has earned, from a college or university accredited by a national or regional certifying authority, at least a master's level degree in chemical or biological sciences, or related discipline, and a minimum of five two years of post-degree laboratory management experience or a bachelor's degree in chemical or biological sciences, or related discipline, and a minimum of eight four years of post-degree laboratory management experience.

Justification for these edits: The instrumentation required for quality assurance testing for cannabinoid products is sophisticated, high complexity testing as defined by CLIAA, requiring intensive maintenance and calibration experience across various instrument platforms. Secondly, the director should have experience in developing instrument methods, laboratory procedures and safety and security, and be able to successfully implement and oversee quality control and quality assurance. This requires significant experience beyond the degree and bench level analyst work, as the proposed language would conceivably allow.

Would also highly recommend educational requirements for lab personnel such as bench scientists and instrument technicians. 

3. Paragraph 3: Homogeneity of samples paragraph. Suggest the following change to the requirement:

Immediately prior to producing any cannabidiol oil or THC-A oil product, a pharmaceutical processor shall segregate all harvested Cannabis into homogenized batches. A pharmaceutical processor shall make, at minimum, 3 samples throughout a batch available from each batch to assure homogeneity within each batch, for a laboratory to test for microbiological contaminants, mycotoxins, heavy metals, and pesticide chemical residue, and for purposes of conducting an active ingredient analysis.

Justification for this comment: It is essential that quality throughout a batch is assured - requiring samples to be collected at the begining, middle, and end of a production. This would apply to both the plant batches and oil/resin product batches.

4. Once the plant product is deemed free of contaminants and a oil product is manufactured, quality assurance and safety of those oils also needs to be verified by the same analytical process. Therefore, a minimum of 3-5 samples in a product batch needs to be evaluated for the same contaminants. This is critical since the processing of the plant material to create the oils will concentrate any potential contaminants not detected above acceptable limits in the initial analysis, which may result in concentrations above acceptable safe limits. Additionally, even if the plant samples taken for the original testing are below the acceptable limits for contaminants, the storage and/or processing of those plant materials may lead to contaminants that would be concentrated during product processing.

5. 110-60-300 Lab Regulations does not define or specify requirements for identifying and quantitating the pharmacologically active ingredients (THC, THC-A, CBD, CBDA, and other cannabinoids that are naturally present in cannabis plant material) or identification the terpenes as are required in 110-60-285 Registration of Products. Recommend adding this requirement to this section of the regulations. This would require a clarification of the legislation defining acceptable limits of CBD, THC-A, and THC in plants and products.

As defined in 110-60-285 Registration of Products, the analysis requires precise analytical work to ensure the 97%-103% range for product branding. Even for lab personnel experienced in analyzing and quantitating drugs, this precision and accuracy window is tight. This could lead to cost-prohibitive production and labelling of separate lots over conceivably insignificant analytical differences. The investment of personnel with experience and training and for material and methods to reduce error in the lab will also add exceptional cost. According to the U.S. Department of Health and Human Services FDA document entitled Guidance for Industry Q2B Validation of Analytical Procedures: Methodology, an assay for a drug substance or finished drug product is normally from 80-120% of the test concentration.