Health Canada says it is satisfied that the two companies who recently underwent recalls for the presence of unauthorized pesticides have taken the issue seriously. No other regulatory action will be taken at this time beyond extended expanded monitoring and evaluation.
“The companies have undertaken a series of corrective actions, including strengthening monitoring, enhancing internal operating procedures, and expanding their product testing regimes, says André Gagnon, Media Relations Officer for the regulator. “Health Canada will continue to evaluate the actions taken by these licensed producers to ensure they are in compliance with the regulations regarding the safe and proper use of pesticides on cannabis plants.”
In Late 2016, both OrganiGram and Mettrum issued recall announcements for cannabis sold due to unauthorized pesticides, including myclobutanil and/or bifenazate. In January, this recall was expanded at OrganiGram to include products produced between February 1, 2016 and December 16, 2016. Aurora Cannabis then issued a recall notice shortly after for products they had purchased from OrganiGram. The pesticides in question are myclobutanil in the case of Mettrum and myclobutanil and bifenazate in the case of OrganiGram.
“Health Canada has been in frequent communication with the companies in question, and has undertaken a number of follow up inspections to ensure they are in compliance with federal regulations. The companies have undertaken investigations to try and determine how these unauthorized pesticides were introduced into their supply chain. Based on current evidence, Health Canada is satisfied that the measures put in place will prevent a reoccurrence, however the department will not hesitate to take further regulatory action if warranted.” -André Gagnon, Media Relations Officer for Health Canada
By late January, Health Canada had said the companies had undertaken ‘a series of corrective actions’ against the two producers, “including strengthening monitoring, enhancing internal operating procedures, and expanding their product testing regimes.” In early February, Health Canada added ‘expanded testing regimes’ for both producers.
André Gagnon, Health Canada’s Media Relations Officer, told Lift earlier this year that the agency has numerous options available once they determine how the unapproved product was used, including special conditions placed on license, or even suspensions or revocations.
“While in most cases compliance can be achieved through a cooperative approach between the regulated party and Health Canada, the Department has various enforcement options available, which include adding terms and conditions to the licence, issuing a warning letter, conducting product seizures, or issuing a licence suspension or revocation.”
Gagnon now says that the agency is satisfied with both Mettrum’s and OrganiGram’s responses to the regulator’s concerns, and at this point now further regulatory action is deemed unnecessary.
“Health Canada has worked with the companies to ensure that the recall was communicated appropriately to clients, that any compromised products were quickly removed from the market, and that procedures have been put in place to prevent any reoccurrence,” continues Gagnon.
“Health Canada has been in frequent communication with the companies in question, and has undertaken a number of follow up inspections to ensure they are in compliance with federal regulations. The companies have undertaken investigations to try and determine how these unauthorized pesticides were introduced into their supply chain. Based on current evidence, Health Canada is satisfied that the measures put in place will prevent a reoccurrence, however the department will not hesitate to take further regulatory action if warranted.”
Gagnon says the responsiveness of OrganiGram and Mettrum was factored into the regulator’s decision to not take further action at this time against the companies than the expanded testing requirements and the internal measures the companies have taken.
“Had the companies acted with indifference or recklessness, had they not fully cooperated with Health Canada, or had they undertaken actions that could have posed significant risks to the health and safety of Canadians, stronger enforcement actions, including licence suspension or revocation, would have been considered,” says Gagnon.
Mettrum has since been purchased by Canopy Growth Corporation, and recently Canopy’s CEO, Bruce Linton, issued an apology letter to Mettrum patients, vowing that it won’t happen again and saying the company is undertaking new quality assurance practices to ensure this. Although unverified, the Globe and Mail reported that a former employee told them that Mettrum would hide the pesticides in the ceiling tiles when Health Canada inspectors arrived.
Last week, Organigram announced they had completed their own internal investigation “that ultimately resulted in inconclusive findings with no hard evidence leading to the source of the contamination discovered.” The company says they now undertake a number of measures, including testing of all products for pesticides before sale, and have “installed closed-circuit cameras in areas of its facility that were previously not required to be monitored.”
Although any rooms that contain or can contain cannabis under Health Canada’s Access to Cannabis for Medical Purposes Regulations (ACMPR) are required to have cameras installed, rooms without cannabis are not.
A few days after OrganiGram released this update form their CEO Denis Aresnault, they announced Arsnault would be stepping down as CEO and replaced by former Tilray CEO Greg Engel. Engel quietly stepped down from his position at Tilray in mid 2016. Tilray is a medical cannabis producer based in Nanaimo, BC.
Pesticide residue of both myclobutanil and bifenazate were initially detected on Organigram’s products by a third party lab engaged by another Licensed Producer who had happened to have purchased cannabis from OgraniGram to resell to through their website. Such sales between producers are not uncommon. First, a small internal Type III recall was issued for five lots of product in late 2016, which was then expanded to a Type II recall covering 69 lots by early January. In early January, Aurora Cannabis had also issued a recall notice for products they had purchased from OrganiGram.
Mettrum’s recall began first with the announcement of an internal recall of products in November of last year after inspectors found evidence of the use of a product containing an off-label, unauthorized pesticide, pyrethrin.
Mettrum says they were made aware they were using a plant wash that contained pyrethrin during a routine Health Canada inspection. The product in question, a ‘plant wash’ is said to contain pyrethrin, but did not list it on the ingredients.
Although they are not confirmed to be the product in question, two brands of plant wash used in the cannabis industry, Mighty Wash and Mega Wash Plant, were identified by the Oregon Department of Agriculture (ODA) as mislabeled earlier this year, and containing pyrethrin.
One month later, Mettrum announced they were expanding their recall and reached out to affected patients via email and/or phone. Although the public press release made no mention of the reason behind the expanded recall, phone messages and emails sent to patients did mention myclobutanil.
Until recently, Health Canada had not publicized internal Type III recalls of any product that wasn’t likely to cause health concerns to the general public. At least one media outlet has misrepresented these procedures to claim the information that was provided to patients directly was ‘hidden’ from the general public, despite the company contacting affected patients directly. Likely to avoid such confusion in the future, Health Canada announced in late January of this year that they will begin listing all cannabis recalls, regardless of public risk.
Type III recalls do not generally warrant a public recall, but a Type I or II recall does. In the past, Health Canada has issued public recalls for other medical cannabis, but has not detailed if they were Type I, II or III.
Health Canada lists their three recall types as such
- Type I: a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death,
- Type II: a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote, or
- Type III: a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences.
While myclobutanil and bifenazate are both approved for use on some fruits and vegetables in Canada (peppers, tomatoes, leafy greens), there is no research available on the health effects of the inhalation of either of these products via either smoking or vaporizing, or in potentially highly concentrated amounts in cannabis oils or extracts.
Mettrum’s letter assured patients there were no health risks associated with the product:
“Rest assured, this material is not deemed to present a health risk. The fungicide Myclobutanil is used widely in Canada and around the world on food crops including lettuce, fresh fruit, and berries.”
At least one class action suit is being investigated to address patient health concerns.
While there are 13 currently approved pesticides for use under the ACMPR, there are potentially hundreds of pesticides that are not allowed. Health Canada testing requirements have not required testing for unauthorized pesticides. Such tests can be costly, adding overall costs to consumers. However, both myclobutanil and bifenazate, along with a few other pesticides like pyrethrum are well known to be commonly used in cannabis production in the black market to deal with issues like powdery mildew or other pests.
For more on the subject of recalls of medical cannabis in Canada from Lift click here.
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