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Bureau of Marijuana Control California Code of Regulations Title 16, Division 42 Medical Cannabis Testing Laboratories Initial Statement of Reasons

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Bureau of Marijuana Control California Code of Regulations Title 16, Division 42 Medical Cannabis Testing Laboratories Initial Statement of Reasons BUREAU OF MARIJUANA CONTROL CALIFORNIA CODE OF REGULATIONS TITLE 16, DIVISION 42 MEDICAL CANNABIS TESTING LABORATORIES INITIAL STATEMENT OF REASONS HEARING DATES: June 1, 2017; June 8, 2017; June 13, 2017; June 20, 2017 SUBJECT MATTER OF PROPOSED REGULATIONS: Medical Cannabis Testing Laboratories SECTIONS AFFECTED: 5237, 5238, 5241, 5244, 5247, 5250, 5253, 5256, 5259, 5262, 5265, 5268, 5271, 5274, 5277, 5280, 5283, 5286, 5289, 5292, 5295, 5298, 5301, 5304, 5307, 5310, 5313, 5316, 5319, 5322, 5325, 5328, 5331, 5334, 5337, 5340, 5343, 5346, 5349, 5352, 5355, 5358, 5361, 5364, 5367, 5370, 5373, 5376, 5379, 5382, 5388, 5397, 5400, and 5403. BACKGROUND The Medical Cannabis Regulation and Safety Act (MCRSA or Act) provides a statutory framework for the licensing of commercial cannabis businesses within the State of California. The MCRSA established the Bureau of Medical Cannabis Regulation, which through the passage of proposition 64, was renamed the Bureau of Marijuana Control (bureau) within the Department of Consumer Affairs (DCA). The bureau was created to license and regulate dispensaries, distributors, transporters, and testing laboratories under the MCRSA. Until now, the state has not comprehensively regulated the medical cannabis industry. The bureau’s proposed regulations address the specific implementation for testing laboratories to be regulated by the bureau pursuant to the MCRSA. General licensing regulations as well as distributor, transporter, and dispensary regulations have been proposed in another rulemaking package. Additionally, manufacturer licenses will be issued and regulated by the California Department of Public Health (CDPH) and cultivator licenses will be issued and regulated by the California Department of Food and Agriculture (CDFA). While developing all medical cannabis regulations, the three licensing authorities worked cooperatively to strive for consistency in areas of overlap and to create a system that allows for reasonable regulation of the industry as a whole. The bureau and the Department of Public Health worked very closely to develop the proposed testing laboratory regulations. TESTING LABORATORIES STATEMENT OF PURPOSE, PROBLEM, RATIONALE, AND BENEFITS The MCRSA makes clear that the protection of the public is paramount. In keeping with that, the MCRSA requires that the bureau develop procedures for ensuring that all medical cannabis goods are tested prior to delivery to a dispensary for retail sale to medical cannabis patients. The MCRSA requires that all medical cannabis goods be tested by testing laboratories licensed by the bureau for a variety of attributes for the protection of the public. Through the proposed testing Bureau of Marijuana Control, Testing Laboratories Initial Statement of Reasons Page 1 of 294 laboratory regulations, the bureau aims to ensure the medical cannabis goods offered for sale are safe for human consumption. The bureau also aims to ensure medical cannabis patients receive accurate information regarding the medical cannabis goods they consume. First, the MCRSA requires the bureau, with assistance from the CDPH, to develop health- protective levels for moisture content, contaminants, residual solvents, microbiological impurities, and foreign material. Consumable medical cannabis goods are at risk of contamination similar to other consumable products. Contamination may occur during various stages of the cultivation, harvest, extraction, processing, and packaging processes. Some of the types of contamination that can make a medical cannabis good unsafe involves pesticides, residual solvents and processing chemicals, microbiological impurities, heavy metals, and foreign material. These proposed regulations aim to set forth action levels that the bureau considers are both protective of public health and achievable by industry. The proposed exposure limits are necessary to ensure, to the extent feasible, that no medical cannabis patient will suffer material impairment of health from exposure to contaminants in medical cannabis goods. As such, these contaminants are discussed in greater detail: Chemicals During the cultivation and manufacturing process, injurious chemicals can contaminate medical cannabis goods. For instance, solvents are used to extract, in concentrated amounts, cannabinoids from dried flower. Some of the chemicals used as solvents may linger after the processing is finished. When present in products intended for human consumption, excessive amounts of these residual solvents and processing chemicals may pose risks to human health. Microbiological impurities Some Escherichia coli (E. coli) strains can cause human disease. One strain produces a toxin called Shiga toxin, which can result in serious illness. Because of the low infectious dose required for disease causation, the bureau proposes there be zero tolerance for the presence of Shiga toxin–producing E. coli in medical cannabis goods. In addition, the presence of Salmonella in cannabis has been documented and, in 1981, resulted in a multistate outbreak. It has also been associated with gastrointestinal disease in both healthy and in immunocompromised populations. The bureau proposes testing for all Salmonella strains. There have been a number of cases involving immunocompromised people who have become ill, or died, from inhaling Aspergillus. Aspergillus is a fungus that can cause serious health problems. Certain Aspergillus strains can cause a variety of immune- reaction lung disorders, ranging from asthma, allergic bronchopulmonary aspergillosis, and hypersensitivity pneumonitis to invasive systemic fungal infections. The bureau proposes testing for this fungus. Bureau of Marijuana Control, Testing Laboratories Initial Statement of Reasons Page 2 of 294 Mycotoxins Mycotoxins are toxic substances produced by certain fungi that can grow on human food and animal feed grain. Human exposure to mycotoxins, through ingestion, inhalation, and dermal contact, has been associated with severe human health impacts that include necrosis, cirrhosis, and carcinomas. The bureau proposes requiring testing for certain mycotoxins. Foreign material Medical cannabis products may be injurious to health if they consist in whole or in part of any filthy, putrid, or decomposed substances or is otherwise contaminated by any added poisonous or added deleterious substance. This may occur if the medical cannabis goods have been stored, prepared, or packed under unsanitary conditions. Heavy metals Cannabis plants are known to uptake metals from contaminated growth media (for example, soil), which increases the risk of adverse health effects associated with the consumption of medical cannabis goods. For example, exposure to lead may cause neurological, reproductive, developmental, immune, cardiovascular, and renal health effects. And mercury shows toxicological effects such as neurological, corrosive, hematopoietic, and renal effects as well as cutaneous disease (acrodynia). Second, the proposed regulations set minimum standards for testing laboratories. There are inherent challenges to regulating an industry that has not been federally regulated and has only been newly regulated in other states. With regard to cannabis testing laboratories, one challenge the bureau faced when developing these proposed regulations was lack of generally accepted validated methods for the testing of cannabis. Therefore, it was imperative the bureau include regulations regarding how to go about validating testing methods. Another challenge was that there are no certified reference materials for cannabis. Therefore, the bureau proposes that laboratories create their own reference materials until reference materials may be obtained from an outside party, where most other reference materials come from. Additionally, because ISO, the accreditation body for testing laboratories, is a private organization not under the control of the bureau, nor subject to public-record disclosure laws, it was necessary for the bureau to develop its own minimum standards for laboratories. These standards aim to ensure that the laboratories that are testing the medical cannabis goods before retail sale are adhering to laboratory practices that result in accurate information that will be provided to medical cannabis patients through the labeling of medical cannabis goods. These proposed standards would allow the bureau to ensure laboratories maintain high operational standards and conduct valid tests. These testing laboratory standards include ones for sampling procedures, testing-method validation, quality assurance, and laboratory personnel qualifications. Bureau of Marijuana Control, Testing Laboratories Initial Statement of Reasons Page 3 of 294 Sampling Proper sampling collection may be far more consequential than laboratory measurement errors. If a sample of something is improperly obtained, the measurement data that is gathered through analyzing the sample puts the measurement data it produces into question. Proper sampling is therefore critical to obtaining relevant and valid data. In these regulations, the bureau proposes fairly detailed minimum sampling requirements. These requirements include what must go into a testing laboratory’s sampling protocol, training requirements for laboratory agents who will be obtaining samples (“samplers”), and how samples are to be stored. The proposed sampling regulations also make specific the MCRSA provision that requires the laboratory agent collecting the sample to use a “statistically valid sampling method.” A statically
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