Health Canada Continues Investigation of Recent Recalls

Health Canada says they are continuing to investigate the recent recalls from two licensed producers to determine how two unapproved pesticides entered the supply chain, while one testing lab says the regulatory agency needs to require testing for common pesticides.

“With regards to the recent recalls, Health Canada is working with the two licensed producers to ensure that all issues are adequately addressed, that production practices are in compliance with federal regulations and that controls are adequate to prevent the situation from occurring again,” says André Gagnon, Media Relations Officer at Health Canada.

“The companies have undertaken a series of corrective actions, including strengthening monitoring, enhancing internal operating procedures, and expanding their product testing regimes. 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.”

Gagnon says 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.”

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.

Both myclobutanil and bifenazate are common pesticides in cannabis production to control powdery mildew and spider mites.

Myclobutanil is a fungicide commonly used on fruits and vegetables in Canada under the name Nova 40W, and the US under the name Eagle 20. The product is considered “slightly hazardous” by the World Health Organization. According to the EPA in the US, Myclobutanil has a relatively low acute toxicity. The acute oral LD50 for mice is 1360 mg/kg, and ranges from 1.75 to 1.8 g/kg for rats. The toxicity of Myclobutanil when inhaled has not been thoroughly studied. In the US, Eagle 20 was found on numerous cannabis products in 2015.

Bifenazate (Floramite) is a pesticide used to control mites in crops like wine grapes, apples, and nuts. Because of its effectiveness, like Myclobutanil, it’s also been long used in commercial production of cannabis in the unregulated market. Bifenazate is listed by Health Canada as “unlikely to affect your health when used according to label directions,“ however there is no research available on the effects of inhaling combusted bifenazate in humans.

The specific levels of any of these products in these recalls is still unknown, beyond Health Canada’s classification of recalls by Types. OrganiGram and Mettrum have been unavailable for comment. A representative at ECOCert, the agency that provides OrganiGram’s organic certification, said the company is investigating.

“Right now, what I can do is tell you that yes, we are investigating, Health Canada is also investigating, and for now we have to wait and see what’s going on and why that happened. This is as much as I can tell you today,” Gilles Belley, Sales and commercial representation for ECOCert Canada, told Lift last week.

In a recent interview with CBC, OrganiGram CEO, Denis Arsenault said the testing was first found by another licensed producer who they had sold the product to.

“We sold wholesale product to a competitor and they tested for it and that’s how they became aware of it and this was in December, as you know.” Arsenault said.

OrganiGram, he says, is now testing all inputs into the facility and working with Health Canada.

Licensed growers of medical cannabis in Canada are only authorized to use approved pesticides, (currently 13), but are not required to test for unauthorized pesticides. A producer or testing lab would have to specifically look for these types of unapproved pesticides like myclobutanil and bifenazate, either individually, or as part of a broader screening process outside the scope of the mandated testing requirements.

Rene Bilodeau, a chemist at MB Labs, located near Victoria, BC, a company offering testing of cannabis products, says the products are more common in marijuana than many might think, mostly because cannabis is such a valuable crop and there are no requirements to prove you haven’t used it.

Since the testing for unapproved pesticides isn’t required, it’s essentially up to producers to adhere to the honour system, says Bilodeau, and with the value of cannabis crops and the pressure to run a business, the temptation to use pesticides is too great.

“If you’re going to lose a crop, then somebody is going to come in and use a pesticide and not tell anyone about it,” says Bilodeau. “There’s too much money at stake.”

These are common pesticides in cannabis production and Health Canada should require testing for them under the medical regime, says the chemist.

“Obviously, there’s tons of pesticides everywhere, and they need to be screened for more routinely. It doesn’t matter if they come to us or go to another lab, that’s not what it’s about, it’s really about the consumer, making sure they get a pesticide free product. Especially kids that are taking things like concentrated oils. This is supposed to be a medicine and it should be tested like a medicine … I think that Health Canada should be making the testing mandatory.”

Bilodeau says MB Labs charges about $300 for the screening test, but that it can cost upwards of $1,000 through other companies. MB screens for 926 different compounds, using “deconvolution software” and mass spectral libraries. The instrumentation required to test for pesticides is mass spectrometry.

“We wanted to keep it affordable, not just for the LPs, but also other people who are interested in testing, because there are pesticides out there and people are going to use them.”

Gagnon says Health Canada will continue to conduct regular and surprise inspections of producers, and these inspections will include testing for pesticide use.

“The ACMPR requires licensed producers to adhere to strict Good Production Practices in the production of cannabis,” says Gagnon, “which includes ensuring that only the 13 pesticides approved for use on cannabis under the Pest Control Products Act are used during the production process. Health Canada conducts regular, unannounced inspections of licensed producers. During these inspections, Health Canada reviews all facets of the operation, including pesticide use.”

Featured image via Wikipedia.

Source: Lift Cannabis