Microbiological Safety Testing of Cannabis
Cannabis is increasingly becoming legal at the state level in the U.S., for either medical or recreational use. Each of these states has had to wrestle with the question of how to ensure the safety of a new product that is not covered under any existing safety guidelines. Safety testing in other agricultural industries is regulated by the FDA, the USDA, or by other federal agencies, all of which have been unable to assist the states in this case. The few states that have produced safety testing guidelines for Cannabis were forced to develop them from scratch, without the regulatory and scientific support that federal agencies typically provide.
In the absence of this federal guidance, regulators in each state have turned to different sources for information, and each state has produced a unique set of rules and regulations (if they have produced one at all). Many of these are in outright conflict with each other, and they are largely not grounded on scientific research. This whitepaper is focused entirely on the question of microbiological safety, and has been written in order to promote the adoption of regulatory guidelines for the Cannabis industry that are rational, consistent, and safe. We have gathered what data there are on this issue and related ones, and assembled a broad collection of experts on the general subjects of plant microbiology, medical microbiology, and safety-testing of agricultural and food products.
One reason for the difficulty that the states have had with this issue is the unusual delivery route of Cannabis. If Cannabis were not typically consumed by smoking, it would fall more clearly under existing guidelines covering pharmaceuticals or agricultural products. The only potential source of safety regulations pertaining to plant material consumed by inhalation would be the tobacco industry. However, that industry does not publish such information, and has only very recently been subject to any federal oversight at all. Regardless, the appropriate guidelines for this industry will need to take the delivery route into account very clearly. Inhalation presents a different set of health threats than does (for instance) oral ingestion.
The experiences of other industries supply a vast collection of both data and regulatory approaches from which to draw upon. Nonetheless, this industry is unique, and it will be impossible to develop the right regulatory approach without careful customization of the approaches used in other settings. The potential problems associated with a massive industry, arising practically overnight, 4 argue for stronger controls than are in place elsewhere. On the other hand, safety-testing guidelines that are too strict, economically unfeasible, or based on poor science, will be difficult to implement and will have a damaging effect on the industry as a whole.
Our approach in this white paper is try to balance these needs by giving recommendations that will exceed the public health protections in other industries, but not by more than is reasonable or necessary. More specifically, our approach has been to attempt to determine which microorganisms are likely to be present on Cannabis; which of them could potentially replicate to significant levels at any point in the production or use process; and which of these might actually pose a health hazard. We will recommend against testing for any organisms that do not meet these criteria.
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