§ 5726. Certificate of Analysis (COA) (a) The laboratory shall generate a COA only for each primary sample that the laboratory analyzes. (b) The laboratory shall, within 1 business day of completing analyses of a sample, both enter the COA information into the track and trace system and provide a copy of the COA to the requester. (c) The COA shall contain, at a minimum, the following information: . (1) Laboratory’s name, address, and license number; (2) Distributor’s name, address, and license number; (3) Cultivator’s, manufacturer’s, or microbusiness’ name, address, and license number; (4) Batch number of the.batch from which the sample was obtained; (5) Sample identifying information, including matrix type and unique sample identifiers; (6) Sample history, including the date collected, the date received by the laboratory, and the dates) of sample analyses and corresponding testing results; (7) For cannabis samples, the total weight, in grams, of both the primary sample and the total batch size; (8) For cannabis product samples, the total unit count of both the primary sample and the total batch size; (9) The identity of the analytical methods used and corresponding Limits of Detection (LOD) and Limits of QuantiCation (LOQ); and (10) Analytes detected during the analyses of the sample that are unknown, unidentified, or injurious to human health if consumed, if any. (d) The laboratory sha11 report test results for each primary sample on the COA as follows: (1) When reporting quantitative results for each analyte, the laboratory shall use the appropriate units of measurement as required under this chapter;
(2) When reporting qualitative results for each analyte, Che laboratory shall indicate “pass” or “fail”• (3) When reporting results for each test method, the laboratory sha11 indicate “pass” or “fail”; (4) When reporting results for any analytes that were detected below the analytical method LOQ, indicate ”
Proposed Regs. – October 19, 2018
Subsection (c) has been amended to specify the email address for which certificates of analysis (COA) are submitted to at the Bureau. This is necessary to ensure that licensees are correctly submitting the COAs, and that the Bureau is receiving them. Subsection (c) has also been amended to remove the requirement that the testing laboratories must provide the test results to other requestors.
Subsection (d) has been added to the section. The addition of subsection (d) has required the renumbering of subsequent subsections accordingly. New subsection (d) specifies and clarifies that the laboratory shall not release to any person any cumulative or individual test results prior to completing all analysis and providing the COA to the Bureau. This is necessary to ensure that test results remain confidential, pursuant to statutory requirements, and to preserve the integrity of the testing.
A new subsection (e)(1) has been added that requires the COA form to contain the term “Regulatory Compliance Testing” on the upper-right corner of each page of the COA, in a font no smaller than 14-point, with no text or images appearing above that term on any page of the COA. This is necessary to ensure that those reviewing the COA are aware it is a COA for regulatory compliance testing, and to preserve the integrity of the testing.
Subsections (e)(2) through (e)(7) have been renumbered and revised to clarify and specify that the address referred to, is the licensed premises address. This is necessary to ensure that the COA contains correct information that accurately reflects the licensee information.
Subsection (e)(2) has been amended to remove the term “physical” and replace it with “licensed premises” for clarity.
Subsection (e)(3) has been revised to specify that the subsection applies to microbusinesses that have been authorized to engage in distribution. This is necessary to prevent potential confusion regarding which type of microbusiness the subsection may apply to.
Subsection (e)(4) has been amended to remove the term “physical” and replace it with “licensed premises” for clarity.
Subsection (e)(5) has been revised to clarify that packaged cannabis goods must have a labeled batch number that matches the batch number of the COA. This is necessary to ensure that licensees and the Bureau are able to clearly identify the batches held by the licensee as well. This will also reduce the risk of potential error and confusion in matching up COAs with their respective batches.
Subsection (e)(8) has been renumbered and revised to clarify and specify that the picture on the COA of a sample must include an unobstructed image of the packaging if the sample is pre-packaged. This is necessary to ensure accurate identification of the sample and compliance with testing and labeling.
Subsection (f)(5) has been amended to clarify that the section does not apply to the reporting of cannabinoid results. Former subsection (f)(5) has been removed because it is no longer necessary due to the changes in label claim review.