Clarification from Health Canada on myclobutanil and cannabis

Health Canada's first priority is to protect the health and safety of Canadians. This is the guiding principle of the regulations that govern Canada's medical cannabis industry, the Access to Cannabis for Medical Purposes Regulations (ACMPR). Canada has some of the most stringent controls on the medical cannabis industry in the world, and licensed producers are required to adhere to strict Good Production Practices designed to provide a safe supply of medical cannabis for Canadians.

The regulations and their accompanying compliance and enforcement measures have worked effectively since the industry's inception in 2013. Health Canada verifies that the regulations are followed by undertaking compliance measures that include multiple unannounced inspections of each licensed producer every year. For example, during the 2015-16 fiscal year, Health Canada conducted more than 300 inspections of 30 licensed producers, the results of which can be found online. If these inspections identify non-compliance, the Department has a range of enforcement options available, including education, recalls, adding terms and conditions to a licence, licence suspension or licence revocation.

Recently, two licensed producers undertook voluntary recalls after it was found that they had used unauthorized pesticides, including myclobutanil.

The regulations are clear - licensed producers are responsible for ensuring that their products comply with the regulations. Under the ACMPR, licensed producers are permitted to use only the 14 pesticides that are currently approved for use on cannabis under the Pest Control Products Act. The use of any other pesticides, at any stage of cannabis production, is prohibited.  

Health Canada has already outlined many of the known health risks of cannabis use, including risks from inhalation. However, recent media reports about these recalls have suggested that there was a significantly increased risk to the health of Canadians who inhaled the recalled cannabis products, due to the release of hydrogen cyanide.  

Here are the facts. When the cannabis plant is combusted, a number of compounds are produced, including very low amounts of hydrogen cyanide. Health Canada's analysis of the recalled cannabis products show that the trace levels of myclobutanil that were present would have produced a negligible amount of additional hydrogen cyanide upon combustion, in comparison to the levels already produced by marijuana alone. Specifically, the level of cyanide from the burning of myclobutanil found on the cannabis samples is more than 1000 times less than the cyanide in cannabis smoke alone, and is 500 times below the acceptable level established by the U.S. National Institute for Occupational Safety and Health. As such, the risk of serious adverse health consequences resulting from the inhalation of combusted myclobutanil in the recalled cannabis products was determined by Health Canada to be low.  

In each of these instances, Health Canada moved quickly to verify that compromised products were removed from the market and that clients of the licensed producers were contacted. Health Canada's enforcement response considered the low health risk posed by the trace amounts of unauthorized pesticides detected and took into account the companies' full cooperation with the Department during the recall process and subsequent investigations. To help ensure adherence to the Good Production Practices, Health Canada added new terms and conditions to the licences of the affected producers requiring testing for unauthorized pesticides.

While the risk of harm to Canadians was low in these recent cases, Health Canada has engaged all 39 licensed producers to ensure that they understand the federal regulatory requirements around authorized pesticide use, and that a repeat of the situation that led to these recalls is unacceptable. Health Canada has already announced that it will begin random unannounced testing of cannabis and cannabis products from licensed producers to verify the overall state of compliance. The Department will undertake additional measures, as required, consistent with its evidence and risk-based approach to regulation.  

Health Canada would like to assure Canadians that had there been any evidence to show that a licensed producer had acted with indifference or recklessness and engaged in activities that put the health or safety of Canadians in danger, the Department would have responded with appropriate enforcement actions, including licence suspension or revocation. 

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