Just weeks ago, the first voluntary cannabis product recall occurred under California’s new regulations. According to an article on MJBizDaily.com by John Schroyer, the recall for their vaporizer cartridges affects almost 100 dispensaries in California.
Bloom Brands, the company issuing the voluntary recall, mentioned in a press release that batches sold between July 1-19, 2018 were contaminated with the pesticide Myclobutanil and therefore does not meet the Bureau of Cannabis Control (BCC) standards. Below is an excerpt from the press release:
We are working closely with the BCC to remedy this issue and expect clean, compliant products to be back on shelves in three weeks…. At Bloom, we are continuing to work with the BCC and other partners to ensure that the space is properly regulated and safe for all customers. Transparency and safety remain our top concerns and we will provide updates as additional information becomes available. We apologize for any concern or inconvenience this serious misstep has caused. We thank you for your continued trust and confidence in our products.
Then, just days later, Lowell Herb Co. issued a voluntary recall on their pre-rolls. First reported by MJBizDaily.com, it appears the products initially passed multiple lab tests and was cleared for retail sales. Weeks after the batch passed tests, a laboratory reversed its decision, saying the products failed to pass the state’s testing standards. The contaminant in question was not mentioned.
Many seem to think these recalls are a product of the BCC’s unrealistic expectations in their lab testing rules. In a Facebook post days ago, the California Cannabis Industry Association called out the BCC for their unworkable rules. “The BCC has set testing standards that are nearly impossible to meet,” reads the post. “As a result recalls like this will be the norm and the industry will suffer a bottleneck in supply. Testing standards need to be realistic, not impossible.”
Last week, the Colorado Department of Revenue (DOR), the Colorado Department of Agriculture (CDA) and the Colorado Department of Public Health and Environment (CDPHE) announced a health and safety advisory for a large number of cannabis products grown and produced by Tree of Wellness Inc., doing business as Tree of Wellness. The health and safety advisory, synonymous with a product recall, was issued due to the detection of off-label pesticides in cannabis grown by Tree of Wellness.
Tests found Myclobutanil present in batches going all the way back to May, 2017, with some contaminated batches as recent as late October.
According to the press release, the CDA confirmed the presence of Myclobutanil, a near-ubiquitous fungicide used in a wide range of agricultural practices. The chemical has been a thorn in the side of the cannabis industry for being used off-label, or inappropriately, on cultivating cannabis.
Myclobutanil is the active ingredient in Eagle 20, a pesticide used frequently in other agricultural fields like grapes, apples and spinach. According to UC Davis professor and Steep Hill scientist Dr. Don Land, Myclobutanil becomes significantly more dangerous when heated, or smoked. That chemical reaction produces hydrogen cyanide, an extraordinarily toxic chemical. Because of this, and the lack of research on what happens when these chemicals are burned or heated, there is a growing public concern that cannabis laced with a chemical like Myclobutanil can cause adverse health reactions.
The public health and safety advisory says they detected Myclobutanil in cannabis flower, trim, concentrates, and infused-products from Tree of Wellness. The CDPHE and DOR recommend consumers that have the affected products return them to where they were purchased for proper disposal.
Consumers in Colorado should check their labels to see if their products fall under the recall. Look for the Medical Optional Premises Cultivation License 403-00664 and/or Medical Marijuana Center License 402-00443. The recall includes batches of 23 different strains grown by Tree of Wellness.
Broken Coast Cannabis Ltd., a cannabis business located on Vancouver Island, issued a voluntary recall of three cannabis lots due to the detection of pesticides. According to the safety alert published on Health Canada’s website, the voluntary Type III recall follows an inspection of the facility back in March of this year.
A Type III recall means those products are not likely to cause negative health effects. Sampling of those three cannabis lots found a cannabis oil product in July to contain low levels of Myclobutanil and Spinosad.
Upon further testing, a cannabis leaf sample was found to contain 0.017 parts-per-million of Myclobutanil. A third party laboratory confirmed the presence of that fungicide, leading them to recall three lots of dried cannabis sold between July and December of 2016, according to that safety alert.
Spinosad, an insecticide, and Myclobutanil, a fungicide, are not authorized for use with cannabis plants per the Pest Control Products Act, however they are approved for use in food production. The health risks of ingesting either of those two chemicals are well documented. “Health Canada has not received adverse reaction reports related to Broken Coast Cannabis Ltd.’s products sold affected by the recall,” reads the safety alert. “Health Canada recommends that any individual affected by the recall immediately stop using the recalled product and to contact Broken Coast Cannabis Ltd., at the following number 1-888-486-7579.”
The medical cannabis sector is currently attracting increased attention, as patients, doctors, regulators and investors take a closer look at our industry. There is a lot for them to learn and to benefit from as our industry matures under the glare of the proverbial spotlight. And there’s a lot for those of us in the industry to be proud of. We’re helping patients manage pain, for example. We’re helping them get their lives back.
But that same spotlight is also revealing some problems in our industry.
Take ingredients for example. When I look at the ingredient list in my natural medicines, I don’t expect to see Myclobutanil, Piperonyl Butoxide, Pyrethrin, Bifenezate, and Avermectin listed. Yet, that’s exactly what some licensed producers of cannabis in Canada and some cultivators in California have been selling to their patients. You have to ask yourself why, when pesticides are the only toxic substances released intentionally into our environment to kill living things. Patients don’t take cannabis to harm themselves. They do it to improve their quality of life.
Yet some cannabis companies have violated their patients’ trust in supplying them with something that could harm them. Indeed, recalls for cannabis, unfortunately, are now becoming somewhat commonplace on both sides of the border. These licensed producers – audited and approved by government – are entrusted to produce safe, reliable, consistent medicine for patients. They are entrusted to put safety at the core of their business at all times. But that is clearly not the case in certain circumstances.
In the past year, a few of the 52 licensed producers in Canada have been found to have pesticide contamination in their cannabis products. From what I can see, the explanations given for the presence of these pesticides don’t make sense. Pyrethrin, for instance, has been found on some medical cannabis products shipped out of certain growing facilities. However, pyrethrin does not naturally appear on plants. It has to be intentionally applied, accidentally or otherwise.
That means, in cases where this pesticide has been found on products after they left the growing facility, two things had to have happened. First, someone introduced it onto the plants to deal with an insect infestation. And second, lax quality control standards – perhaps influenced by a short-term focus on profits over patients – allowed infected products to enter their supply chain and, in many cases, to be consumed by patients.
When revealed, those responsible for companies using pesticides such as pyrethrin say they are “shocked”, publicly declaring that they have no clue as to how these toxic substances entered their cultivation processes. The fact is, if you don’t test your inputs, if you fail to test your outputs, and if you manage your business for short-term profits, you shouldn’t be producing cannabis.
There’s no place in healthcare for people who disregard a patient’s well being, because – from a patient’s perspective – what you don’t know could hurt you. No one who grows something can absolutely guarantee that a mistake will never be made, granted. But as the cannabis sector expands, experienced cannabis firms know there’s a direct correlation between attention and leadership: as the world pays more attention to our sector, the onus on us to be stewards in and for our industry also rises.
That means putting patient safety at the centre of everything we do. And that means ensuring patients are consuming safe cannabis produced by licensed companies that are committed to the long-term health and prospects of our growing industry.
Denver-based Green Man Cannabis last week voluntarily recalled batches of cannabis sold to both medical patients and recreational consumers. The recall comes after the discovery of off-label pesticides during inspections in both dry-flower cannabis and infused products.
According to the Denver Department of Environmental Health (DEH), the products have labels that list an OPC License number of 403-00738, 403-00361, or 403R-00201. The cannabis in question is not a specific batch, rather, “All plant material and derived products originating from these cultivation facilities are subject to the recall.” The DEH’s statement includes contact information for the company (email: email@example.com) and the DEH Public Health Inspections Division (email: firstname.lastname@example.org or 720-913-1311).
The DEH statement does not mention which pesticides were detected or the levels at which they were detected. Christian Hagaseth, founder of Green Man Cannabis, says the chemical detected was Myclobutanil. “We had used Eagle 20 in the past, [the pesticide that contains Myclobutanil] but we stopped using it as soon as it was banned,” says Hagaseth. “The DEH found the residues in the growing environment so we immediately performed a voluntary recall.” Green Man has three cultivation facilities, one of which they suspect is contaminated from pesticides sprayed a few years ago.
As far as corrective actions being taken, Hagaseth says they are doing a thorough cleaning and sanitation in two of their grows and a complete remediation plan in the suspected contaminated grow. “This was a good learning experience- the key takeaway for us is we need to clean these environments more consistently,” says Hagaseth. “I am grateful that the system is working; public health and environmental safety are being looked after here.” Hagaseth says the facility in question was operating almost without interruption since 2009, but they adjusted and learned to implement preventative actions following the recall.
The DEH says there have been zero reports of illness related to the recall. “The possible health impact of consuming marijuana products with unapproved pesticide residues is unknown,” the statement reads. “Short and long-term health impacts may exist depending on the specific product, duration, frequency, level of exposure and route of exposure.” The DEH advises consumers that may be concerned to reach out to their physician.
The DEH performs routine inspections of cannabis infused product manufacturers and retail locations in Denver, as well as investigating complaints. “I am sorry that it happened to us, but I am happy the system is working and we are more than happy to comply,” says Hagaseth.
Cannabis sold between August and December of 2016 is being voluntarily recalled by Organigram, a Canadian cannabis producer, due to the detection of unapproved pesticides, according to a press release. Organigram is a licensed medical cannabis producer in Canada, which received an organic certification back in 2014 by ECOCERT, a third-party organic certification organization based in France.
Organigram and Health Canada deemed it a Type III recall, meaning “a situation in which the use of, or exposure to, dried marijuana, fresh marijuana or cannabis oil, marijuana plants or seeds is not likely to cause any adverse health consequences,” according to that press release. They don’t know how the products were contaminated as routine use of pesticides is barred under their organic certification. Organigram is cooperating with Health Canada to conduct a full investigation to determine how the cannabis was contaminated.
About a month before Organigram’s recall, Mettrum Health Corp., a Toronto-based licensed medical cannabis producer, voluntarily recalled medical cannabis products that might have contained trace levels of pyrethrin, an insecticide not approved for use on cannabis, but generally regarded as safe with a low toxicity. That press release only mentions the detection of pyrethrin and downplays the health effects. “While the ingredient is not harmful and there is no negative effect on product quality and safety, we are doing everything possible to ensure client satisfaction and confidence is upheld,” says Michael Haines, director and chief executive officer of Mettrum Health Corp.
Reporting in an article last week, The Globe and Mail discovered that Mettrum’s recall included lots where they detected trace levels of Myclobutanil, a hazardous and illegal pesticide that is banned in a number of states as well. Myclobutanil has been discovered as the culprit in a slew of pesticide-related recalls in Colorado and Washington.
But Mettrum’s updated press release doesn’t include any mention of Myclobutanil. Health Canada also didn’t make any public disclosures addressing the detection of Myclobutanil. The Globe and Mail only found out that the recall included the banned pesticide after asking a Mettrum employee.
Tegan Adams, business development manager at Eurofins-Experchem Laboratories, Inc., a Toronto-based GMP testing lab, indicated that while the regulations are clear in their statement on zero tolerance for pesticides- reasons for inconsistent testing results are in part related to variations in rigor of testing methods available to monitor for pesticides in cannabis. “Licensed producers do not have to release routine test results to the public,” says Adams. “There is a group of us, inclusive of representatives from licensed producers (LPs), working on proposing a new federal cannabis accreditation standard that would make testing results, grading quality, DNA and a few other things public for each cannabis batch legally released to the public to be accredited. Making information like this public would help remove a lot of consumer scrutiny on LPs, as it currently exists in the marketplace. Most of them care so much about their products and patients, they work very hard to create safe quality products”
According to Adams, routine pesticide testing typically scans for roughly 100 pesticides. She says a more rigorous test could scan for 500-700 different pesticides, a more accurate representation of what’s on the market. Adams says the regulations have zero tolerance for any detection of pesticides, not necessarily an action level for what is a safe amount to be present.
More research is needed on the smoking and inhalation aspects of pesticide products to say what is safe and what is not. “There are different methods available to test for pesticides, and SOPs to follow to avoid their application,” says Adams. “But if a licensed producer chose a testing method that doesn’t for some reason cover a pesticide they are later found to have on their product, that could present the need for a recall if Health Canada or another entity were to somehow to detect it using a different method.”
Health Canada determined both of those recalls to be Type III recalls. Both companies said they are cooperating fully with the regulatory body. By embracing the proposed new cannabis testing accreditation standard, Health Canada could remedy the testing methodology discrepancies and require a greater level of transparency.
Last week, the Oregon Health Authority (OHA) published a bulletin, outlining new temporary testing requirements effective immediately until May 30th of next year. The changes to the rules come in the wake of product shortages, higher prices and even some claims of cultivators reverting back to the black market to stay afloat.
According to the bulletin, these temporary regulations are meant to still protect public health and safety, but are “aimed at lowering the testing burden for producers and processors based on concerns and input from the marijuana industry.” The temporary rules, applying to both medical and retail products, are a Band-Aid fix while the OHA works on a permanent solution to the testing backlog.
Here are some key takeaways from the rule changes:
THC and CBD amounts on the label must be the value calculated by a laboratory, plus or minus 5%.
A harvest lot can include more than one strain.
Cannabis harvested within a 48-hour period, using the same growing and curing processes can be included in one harvest lot.
Edibles processors can include up to 1000 units of product in a batch for testing.
The size of a process lot submitted for testing for concentrates, extracts or other non-edible products will be the maximum size for future sampling and testing.
Different batches of the same strain can be combined for testing potency.
Samples can be combined from a number of batches in a harvest lot for pesticide testing if the weight of all the batches doesn’t exceed ten pounds. This also means that if that combined sample fails a pesticide test, all of the batches fail the test and need to be disposed.
Butanol, Propanol and Ethanol are no longer on the solvent list.
The maximum concentration limit for THC and CBD testing can have up to a 5% variance.
Process validation is replaced by one control study.
After OHA has certified a control study, it is valid for a year unless there is an SOP or ingredient change.
During the control study, sample increments are tested separately for homogeneity across batches, but when the control study is certified, sample increments can be combined.
Failing a test
Test reports must clearly show if a test fails or passes.
Producers can request a reanalysis after a failed test no later than a week after receiving failed test results and that reanalysis must happen within 30 days.
The office of Gov. Kate Brown along with the OHA, Oregon Department of Agriculture (ODA) and Oregon Liquor Control Commission (OLCC) issued a letter in late November, serving as a reminder of the regulations regarding pesticide use and testing. It says in bold that it is illegal to use any pesticide not on the ODA’s cannabis and pesticide guide list. The letter states that failed pesticide tests are referred to ODA for investigation, which means producers that fail those tests could face punitive measures such as fines.
The letter also clarifies a major part of the pesticide rules involving the action level, or the measured amount of pesticides in a product that the OHA deems potentially dangerous. “Despite cannabis producers receiving test results below OHA pesticide action levels for cannabis (set in OHA rule), producers may still be in violation of the Oregon Pesticide Control Act if any levels of illegal pesticides are detected.” This is crucial information for producers who might have phased out use of pesticides in the past or might have began operations in a facility where pesticides were used previously. A laboratory detecting even a trace amount in the parts-per-billion range of banned pesticides, like Myclobutanil, would mean the producer is in violation of the Pesticide Control Act and could face thousands of dollars in fines. The approved pesticides on the list are generally intended for food products, exempt from a tolerance and are considered low risk.
As regulators work to accredit more laboratories and flesh out issues with the industry, Oregon’s cannabis market enters a period of marked uncertainty.
On Election Day, voters in California passed Proposition 64, establishing a recreational cannabis market and regulatory environment. While the state won’t issue the first licenses under the new regulatory scheme until 2018, the medical cannabis industry is already well established.
Steep Hill Labs, Inc., based in Berkeley, California, found in October that 84.3% of samples submitted tested positive for pesticide residue, according to a press release. The announcement came before Election Day, but is particularly eye opening given the massive new market created overnight by Prop 64.
Particularly concerning is their detection of Myclobutanil, which was found in more than 65% of samples submitted to the lab. According to the press release, when Myclobutanil is heated (i.e. smoked or vaporized), it is converted to Hydrogen Cyanide, which is extraordinarily toxic to humans and can be fatal in higher doses.
According to Reggie Gaudino, Ph.D., vice president of science, genetics and intellectual property at Steep Hill, their more recent study shows they detected pesticides in roughly 70% of the samples they received and 50% of those contained Myclobutanil. Gaudino says that up to a third of those samples would have failed under Oregon’s regulatory standards.
If a lab test were failed, it would contain pesticides at or higher than the required action level. Oregon’s action level, or the measured amount of pesticides in a product that the OHA deems potentially dangerous, for Myclobutanil is 0.2 parts-per-million (PPM). Steep Hill’s instrumentation has a method detection limit down to the parts-per-trillion (PPT) level, which is a more precise and smaller amount than Oregon’s action level.
“Those in the cannabis community who feel that all cannabis is safe are not correct given this data – smoking a joint of pesticide-contaminated cannabis could potentially expose the body to lethal chemicals,” says Jmichaele Keller, president and chief executive officer of Steep Hill. “As a community, we need to address this issue immediately and not wait until 2018.”
Potentially harmful pesticides, and specifically Myclobutanil, have been detected in Colorado and Washington’s recreational markets on a number of occasions, proving this is a widespread issue. Steep Hill’s release suggests that California regulators take a look at Oregon’s pesticide regulations for guidance when developing the regulatory framework.
What’s even more troubling is that not all laboratories have or had the capability of detecting pesticides at sufficiently low levels and because of this, other labs had significantly lower rates of pesticide detection, suggesting possible inconsistencies in testing methods, instrumentation, sample preparation or other variations. During a 30-day period in late September and early October, Steep Hill found, using publicly available data, or data from contracted testing, that other labs were only reporting between 3% and 21% pesticide detection.
It is important to note that those samples were not identical and there could be a great degree in variation on the quality of samples sent to different laboratories, so it is not an entirely accurate comparison. Steep Hill does however detect pesticides down to the parts-per-trillion level, whereas many common methods for detecting pesticides look at the parts-per-billion level.
Reggie Gaudino says the Association of Commercial Cannabis Laboratories (ACCL) is using this data to work with Steep Hill and a number of other labs to address these issues. “As a member of the ACCL, and after discussion with ACCL, we have agreed that all future discussion of this issue should not include laboratory names, as this is about educating the industry in general, and making sure all members of the ACCL are developing the best possible methods for detecting pesticides,” says Gaudino. “The ACCL has responded to this data, by inquiring on a larger, industry-wide basis, which represents a better picture of the issue, rather than only in California’s still-technically unregulated market.” The important message is this is a major issue that needs addressing urgently. “As such, the troubling issue remains, across the larger ACCL membership, there is still detection of pesticides in at least 50% of the cannabis being tested.”
According to Jeffrey Raber, Ph.D., president of the ACCL, the industry is experiencing a pesticide problem, but it is very difficult to quantify. “It is fair to say that around 50% of the cannabis being tested contains pesticides, but we really don’t know that exact number until a much more comprehensive statistical analysis is performed,” says Raber. “We agree this is a big problem and that it needs to be addressed, but we are not sure just how big of a problem it really is.” With so much variation in labs in a state where not everyone is required to test products, it is very difficult to pin down how consistent lab results are and how contaminated the cannabis really is. “If all of the labs had the same methodology, samples and shared statistical analyses for a real study then we can look at it closely but it seems we are a ways off from that. I can say confidently however that this is a pretty significant problem that needs addressing.”
Still, Steep Hill detecting pesticides in a majority of their samples and some labs finding as little as 3% should raise some eyebrows. “Unfortunately, our recent study discovered that 84.3% of the samples assessed by our triple quadrupole mass spectrometer contained pesticides,” says Keller. “As of today, this tainted product could be sold in most dispensaries throughout the state of California without any way of informing the patients about the risks of pesticide exposure.”
These findings could mean potentially enormous health risks for medical and recreational cannabis consumers alike, unless regulators, labs and growers take quick action to address the problem.
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