Tag Archives: recall

Canadian Company Recalls Contaminated Cannabis

By Aaron G. Biros
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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.”

OLCC Issues First Recreational Cannabis Recall for Oregon

By Aaron G. Biros
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On March 18th, the Oregon Liquor Control Commission (OLCC) issued its first recall for recreational cannabis products. The recall, according to the press release, occurred because an unnamed wholesaler sent cannabis products to a retailer before the pesticide test results were entered into the OLCC Cannabis Tracking System (CTS).


Photo: Michelle Tribe, Flickr

The cannabis grown at Emerald Wave Estate, LLC is said to fail a test for pyrethrins exceeding the Oregon Health Authority (OHA) action level (the action level for pyrethrins is 1 ppm). Pyrethrins are a class of insecticides derived from the chrysanthemum flower. Their toxicity varies a lot depending on exactly what organic compound was used, but has an acute toxicity level that is cause for concern. When exposed to high levels of pyrethrins, people have reported symptoms similar to asthma. Generally, pyrethrins have a low chronic toxicity for humans.

The retailer, Buds 4 U LLC, located in Mapleton, OR, issued a voluntary recall for 82.5 grams of the strain Blue Magoo sold between March 8th and 10th. After finding the failed test results in the CTS, the retailer immediately contacted the OLCC. According to The Portland Tribune, OLCC spokesman Mark Pettinger says the retailer was very cooperative in immediately notifying the OLCC. “The retailer was great,” says Pettinger. “They get the gold star.” The Portland Tribune also says the wholesaler who shipped the cannabis prior to test results being entered is Cascade Cannabis Distributing of Eugene. That mistake could be a violation of Oregon’s regulations, leading to a 10-day closure and up to a $1,650 fine.

According to the press release, the rest of the nine pounds in the batch is on hold “pending the outcome of an additional pesticide retest.” The OLCC encourages consumers to check if their products have the license and product numbers detailed in the press release. They advise consumers who did purchase the affected cannabis to dispose of the product or return it to the retailer. The press release also mentions that they have not received any reports of illness related to the tainted cannabis.

Green Man Cannabis Recalls Due to Pesticide Residue Detection

By Aaron G. Biros
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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.

Photo: Sheila Sund, Flickr
Photo: Sheila Sund, Flickr

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: recall@greenmancannabis.com) and the DEH Public Health Inspections Division (email: phicomments@denvergov.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.

Christian Hageseth, founder of Green Man Cannabis
Christian Hageseth, founder of Green Man Cannabis

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.

Canadian Cannabis Recalls Raise Questions About Choices in Testing Methods

By Aaron G. Biros
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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.

health-canada-logo

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.

Pesticide Use was a major issue of 2016 Photo: Michelle Tribe, Flickr
Photo: Michelle Tribe, Flickr

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.

teganheadshot
Tegan Adams, business development manager at Eurofins-Experchem

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.

Toronto Photo: Paul Bica, Flickr
Toronto
Photo: Paul Bica, Flickr

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.

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Biros' Blog

Ongoing Pesticide Recalls a Sign of Industry Maturity

By Aaron G. Biros
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plantsjacques

Regulators in Colorado last week announced another massive recall of cannabis found to contain banned pesticides. 92 batches of cannabis plants, with roughly a dozen plants in each batch, were recalled for using the product, Guardian, on the plants. The culprit was an ingredient in the product called avermectin, a pesticide listed as a ‘bad actor’ by the Pesticide Action Network.

The recall follows dozens of others in Colorado this year, all because tests found pesticides present in cannabis samples. When news spreads of cannabis recalls due to concerns of pesticide contamination, it paints a picture of worrisome problems rampant in the cannabis industry. Alarmists say continued recalls could have disastrous consequences like stalling legalization initiatives or slowing growth in new markets.

In the food industry, recalls are a part of routine business. The FDA created the Reportable Food Registry (RFR) as a way to prevent the shipment of contaminated food products into the supply. In 2015, Chipotle Mexican Grill made news when it sickened dozens with an E.coli outbreak and issued extensive recalls as a result. After that happened, the company reevaluated its practices and improved their food safety program to prevent future outbreaks.

When a recall occurs, it should prompt a surge in inquiries, responses and audits that need to be addressed and reviewed carefully. Ample proactive planning including HACCP, comprehensive risk analysis and validation studies or documents help prevent recalls from occurring in the first place. When recalls do happen, reactive measures should occur immediately with a strategy in place to deal with all of the regulatory compliance, quality, safety and branding ramifications.

When a recall occurs in the food industry, it generally means that there was a foodborne illness outbreak, followed by a reactive measure. That reactive measure, the recall itself, is what prevents foodborne illness outbreaks from growing or becoming an epidemic. Recalls in the food industry show that regulators are concerned about contamination and taking action to safeguard public health. In other words, when a recall occurs, it means that someone is watching.

I think recalls in the cannabis industry are a sign of the marketplace growing up. Recalls can be seen as a good thing, a sign of proper safety measures in place to prevent further contamination. Reporting recalls or failures means that professionals are beginning to pay attention to the safety and quality of processes in place at cannabis production facilities. Looking at the long-term sustainability of the cannabis industry, keeping quality and safety at top of mind will help businesses self-legitimize. Those not striving for the safest practices and the best quality will lose their ability to compete as the market continues to grow. Recalls can tarnish a company’s brand, but they also indicate that the industry has reached a point of legitimacy. Cannabis is now out of the closet and under a microscope.

PlantTag

The Importance of Traceability

By Aaron G. Biros
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PlantTag

With the news of Pennsylvania’s medical cannabis legalization measure passing, lawmakers are clamoring for strict regulatory oversight in the form of traceability to prevent diversion and misuse. State Senator Daylin Leach (D- Montgomery/Delaware) introduced the bill and believes it will have the most intensive protections for safety in the country. “Our goal was to create a system that helps as many patients as possible, as soon as possible and as safely as possible,” says Steve Hoenstine, spokesperson for State Senator Leach. “The seed-to-sale tracking system and the bill’s other protections do just that.”

At the recent Cannabis Labs Conference, Cody Stiffler, vice president of government affairs at BioTrackTHC, discussed why traceability is so important. Stiffler previously served as the chief executive officer of the American Medical Management Association, where he fought the Florida prescription drug abuse epidemic. “We originally started tracking prescription medications and methamphetamine precursors to combat the prescription drug abuse and meth epidemic in Florida,” says Stiffler. He focused on providing accountability and traceability, making sure every prescription was legitimate and keeping drugs off the black market. Implementing tracking protocols allowed for the accountability of pharmacists, physicians and patients.

CannabisLabsConference
Cody Stiffler presenting at the Cannabis Labs Conference

The primary goals of a traceability system, according to Stiffler, are to prevent diversion and promote public safety. “We want to advance the cannabis industry with respect to traceability and regulatory compliance by integrating laboratory testing with traceability,” says Stiffler. “Our software helps get safe products to patients and consumers in a responsible manner.”

Stiffler’s role at BioTrackTHC is to provide industry insights to states looking to legalize cannabis and support them with identifying the best practices that meet requirements in their state. Traceability is commonly defined as the ability to verify history, location and application of a product from source to distribution. BioTrackTHC’s tracking software covers everything from seed to sale, involving regulatory bodies in oversight. In the beginning of cultivation, each plant is assigned a bar code or sixteen-digit identifier. According to Stiffler, Colorado’s system uses radio-frequency identification (RFID) tags while Washington’s system gives the business a choice because the software can work with any type of identifier, whether it is a barcode, QR code or RFID tag. “Our system generates those numbers and prevents diversion with a closed loop system,” says Stiffler.

PlantTag
A plant tagged with a barcode and date for tracking

Washington, Illinois, New York, New Mexico and Hawaii are the five states that use BioTrackTHC’s software. “If the state wants to see the chain-of-custody, they can go back in the system and see every touch point and the full life cycle of the product in real time,” says Stiffler. “Our system also incorporates lab testing to ensure no product reaches shelves unless test values are associated with it.”

flowcharttracking
A flowchart showing tracking from seed to sale.

For many states, problems lie not in diversion, but inversion, where black market growers bring their products into the legal market. “A lot of people growing black market product are inverting it into the regulated market,” notes Stiffler. This kind of black market activity can flood the legal market with un-tested cannabis.

Product recalls are examples of when traceability software can be very useful. Pesticides, microbiological contaminants, heavy metals and other contaminants are at issue. Stiffler invokes an example from a company in Washington making THC-infused drinks. “Because of an issue in the manufacturing process, the bottles were exploding in refrigerators and on shelves,” says Stiffler. “Because the product’s lineage was completely tracked, we could isolate all of the products in that specific batch from that specific manufacturer and then forward trace to every retailer that had it in inventory,” he adds. “Whenever someone who did not get the recall notice would attempt to scan that barcode at point of sale, a message appeared noting its recall status and that it is not for sale.” The software’s financial data analytics can provide real time visibility for profit margins or losses resulting from recalls.

According to Stiffler, these kinds of protections in place give law enforcement and government agencies piece of mind that they are helping to prevent diversion and promote public safety. Traceability software is one of the very important safeguards protecting food safety and product safety.

Are You Ready For an Inspection?

By Maureen McNamara, Lezli Engelking
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Would you be proud to have your customers and patients tour your production facility? When health inspectors or enforcement personnel arrive at your location is there sense of panic or pride?

When you have detailed systems in place, inspections should be informative, not stressful. Keep in mind that in the cannabis industry, products are often created for patients. Patients may have a compromised immune system and thus are more susceptible to food borne illnesses, pesticides and other contaminants.

Are you and your team doing everything you can to produce a wholesome and safe product?

According to the World Health Organization, Good Manufacturing Process (GMP) “is a system for ensuring that products are consistently produced according to quality standards.”

GMP is the proactive part of quality assurance. It is designed to minimize the risks involved in all steps of the manufacturing process. A basic tenant of GMP is that quality cannot be tested into a product. It must be built into each batch of product during all stages of the manufacturing process.

GMPs involve much more than most people think. A common misconception is that GMP only covers the process of manufacturing itself. GMPs actually cover all aspects of the production process:

  • Materials
  • Premises
  • Equipment
  • Storage
  • Record Keeping
  • Staff Training to Hygiene
  • How Complaints Are Handled

GMP & The Cannabis Industry

In most industries, agencies that control licensing for the manufacture and sale of a product recommend GMPs, or guidelines to business owners. These guidelines provide minimum requirements that a manufacturer must meet to assure that products are of high quality and do not pose any risk to the consumer or public. The guidelines generally become the basis of regulation for that industry.

In the United States, the Food and Drug Administration (FDA) recommends guidelines for anything food, drug or pharmaceutical related.

Because cannabis still remains illegal at the federal level, none of the federal agencies that would normally develop good manufacturing guidelines have done so. This has left state lawmakers and business owners on their own to navigate this new and rapidly developing industry.

The Foundation of Cannabis Unified Standards (FOCUS) has developed standards with a mission to protect public health, consumer safety and safeguard the environment by promoting integrity in the cannabis industry.

The comprehensive implementation of cannabis specific good manufacturing practices, like the FOCUS standards, across all aspects of the industry will assist business owners and regulators alike, addressing quality proactively at every step in the process, which is critical to protecting consumer safety and public health – and the overall success of a nascent and divisive industry like cannabis.

The FOCUS standards are completing the final phase of development, a thirty-day public review and comment period before being released for use in the marketplace in June. These voluntary consensus-based standards are built on GMPs drawn from agriculture, food production, chemical management, OTCs, pharmaceuticals, and other relevant industries. In addition, the standards draw best practices from the cannabis industry, as well as those published in OSHA, FDA, FTC, CDC, ISO, code of federal regulations and various state-level cannabis regulations.

There are many aspects of creating and implementing GMPs. Here are three to be aware of:

  1. Get the facility design right from the start: It’s much easier to be GMP compliant if the design and construction of the facilities and equipment are right from the start. It is important to embody GMP principles and use GMPs to drive every decision. 
  1. Document what you do and do what you document: Having good procedures in place to ensure a controlled and consistent performance is an essential part of GMP. Procedures should be clear, concise, logical, and available to everyone.
  1. Keep good records: Keeping accurate records is an essential part of GMP. It helps convey that you are following procedures and demonstrates that processes are known and under control. If it’s not written down, it did not happen.

Standards and quality programs in any industry are dynamic by nature. Nothing is static. Standards must constantly be updated to reflect ever-changing market conditions. This is why it is so crucial that regulations are based on them.

To be a standard, there are certain core principals that must be present. However, the goal of a standard is to guide an industry without impeding or controlling it. This is why there is so much inherent value in implementing standards. They bring enough structure to help reduce costs and increase efficiency, but not so much control that individual nuances or creativity is affected.

It is much less expensive to be proactive. Recovering from a recall or contaminated product can not only be costly, it is a massive hit to the company’s reputation. It may take years for sales to recover, and for consumers to trust the product again. Where could you and your team enhance your standards and processes?

Cannabis Coaching & Compliance

Avoiding Recalls: Preparing for the What-Ifs

By Maureen McNamara
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Recalls are a necessary part of our lives, and they occur quite often. There are hundreds of food recalls performed each year. Now we are experiencing recalls in the cannabis industry. It is important to keep in mind that the primary objective of performing a recall is to protect consumer safety.

Welcome to a whole new game!

The Scoop:

A recall occurs to remove defective or potentially harmful products from the marketplace.

Recalls can be expensive and stigmatizing. Companies involved are usually highly motivated to remedy the issue and recover as quickly as possible. It is in the producer’s best interest to do everything in their power to maintain and regain patient & customer confidence and brand trust as soon as possible.

In the United States, food recalls are typically generated by the U.S. Food and Drug Administration (FDA), or by the U.S. Department of Agriculture (USDA) through the Food Safety and Inspection Service (FSIS). Food manufacturers regularly perform mock recalls and, when needed, perform voluntary recalls of possibly contaminated product. Recently, listeria has become a major concern for contamination in the food industry and as a result, many companies are preparing themselves for prevention strategies.

As cannabis is still federally illegal, the FDA does not perform cannabis recalls. As a result, we are seeing local health departments and the state departments of agriculture getting involved in cannabis recalls. Recent recalls are voluntary and are related to potentially dangerous pesticide residue on flower, concentrates and infused products. Colorado has come into the spotlight recently for businesses performing a number of voluntary recalls, in the interest of protecting consumer safety. This January, a recall included “individual units of marijuana concentrates that are used for vaporizing” testing positive for Imidacloprid, Myclobutanil, Etoxazole and/or Avermectin, which are all pesticides determined by the Colorado Department of Agriculture as not usable on cannabis.

How do we know there is a problem?

  • A manufacturer discovers a problem
  • Inspectors reveal a potential issue
  • A product fails a test carried out by a licensed laboratory
  • A state health department may be alerted to an issue

Preparing for the “What- Ifs”

  • What is your crisis management strategy?
  • How will your team communicate the issue with regulators?
  • What is the protocol to recover or destroy recalled product?
  • What is the communication plan with purveyors & consumers?
  • What new structures will be in place to prevent future issues?

How do we avoid a Recall?

Manufacturers and cultivators endeavor to prevent issues in the first place. Good Manufacturing Practices (GMP), Good Agricultural Practices (GAP) and Hazard Analysis and Critical Control Points (HACCP) plans are used to ensure quality and safety during the production process. Mistakes can occur. It is ultimately the manufacturer’s responsibility to remove any possibly contaminated product from the market quickly and before potential damage is incurred.

As we pioneer the cannabis industry, it is important to be as proactive as possible at every step of the supply chain, from seed to the sale of cannabis: Cultivating, trimming, curing, extracting, infusing, producing, packaging, shipping, receiving, storing and selling are all points where safety measures should be in place.

Prevention Rules!

How is your team doing with the following?

  • GAP, GMP & HACCP plans to ensure quality product
  • Testing, TESTING, Testing- to confirm safety of your goods
  • Requiring strict & tested operating procedures from your suppliers
  • Internal quality reviews
  • Training and Accountability

Our desire is that you do not ever need to recover from a crisis, but mistakes happen. They create a learning opportunity for us to make a higher quality product, to strengthen our procedures and to show our consumers that we are committed to excellence.

Pesticide Position Paper: Prepared by Comprehensive Cannabis Consulting (3C)

By Adam Koh, Nic Easley
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Those that follow the legal cannabis industry are undoubtedly aware of the struggles of Colorado to regulate pesticide use on cannabis. At the time of this writing, there have been 19 recalls of products contaminated by pesticides in as many weeks. Authorities could not in all cases identify exactly how many units of products may have been tainted, but based on the numbers available, roughly 200,000 individual cannabis products, if not more, have been pulled from dispensary shelves. Along with these recalls have come a large amount of coverage and commentary from various news outlets, industry stakeholders, and even those companies who have had products pulled from shelves.

As this is a controversial and contentious subject, it can be difficult to parse and evaluate the various points of view being offered. In what follows, we will outline the issues at hand objectively: first providing a brief overview of federal and state pesticide regulations and how they pertain to cannabis; addressing claims of whether pesticide usage is “safe” or not; and, finally, offering our opinion of how the cannabis industry should address the pesticide conundrum considering the current regulatory environment and the state of our knowledge.

Before diving in, we are also aware that there is controversy around cannabis testing methodologies, and that the reliability of cannabis testing labs in general has been called into question by a number of the companies that have faced recalls. While we cannot comment on the operations of particular labs, we do support the application of consistent standards, proficiency evaluations, and stringent regulatory oversight to testing labs themselves, so that their results can be assured of being beyond reproach.

Still, 3C’s stance is that quality cannot be tested into a product. To have growers continue to produce contaminated cannabis only to see it recalled repeatedly is unsustainable for the industry; indeed, it threatens its very existence, as we discuss below. That is why we focus in this paper on the cultivation of the plant, as correcting problems on the production side is the only way to ultimately resolve the dilemma in which the industry finds itself.

Pesticide Regulation in the US Relative to Cannabis Cultivation

Cannabis’ pesticide problems stem in large part from the fact the pesticide regulation takes place at the federal level, under the auspices of the EPA. All pesticides undergo years of research and development before they can be sold to farmers and employed on crops. That research addresses questions such as where and how a pesticide can be employed, on what crops, in what concentrations, with what frequency, and how long before harvest can a pesticide be applied. Questions of worker safety are also addressed, such as those concerning what Personal Protective Equipment (PPE) might be required and how long workers must avoid treated areas (Re­Entry Intervals), among other concerns.

The fruits of such studies are then distilled to the contents of a pesticide’s label, which must be registered with and approved by the EPA before a pesticide can be distributed for sale. Federal and state laws require that pesticides be applied according to label directions, making the label a legal document of sorts. “The label is the law,” is a phrase common among agricultural professionals with which the legal cannabis industry is becoming acquainted.

The sticking point in regard to cannabis is that, due to its federal illegality, no research has been performed on the use of pesticides on cannabis. Due to the lack of research, no pesticides registered currently with the EPA are labeled for use on cannabis. Since all pesticides must be applied according to label specifications, this essentially prohibits pesticide use in cannabis production. However, some labels are written in such a broad manner that the use of those pesticides could not be construed as a breach of the legally­ binding use directions. Additionally, certain pesticides are of such low­toxicity that the EPA has deemed that their registration is not required; these are known as minimum­ risk products under section 25(b) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). At this time, the Colorado Department of Agriculture (CDA), in an attempt to offer guidance to cannabis growers, is maintaining a list of such products that, either due to broad label language or 25(b) status, may be used on cannabis without that use being a violation of the label.

Are Pesticides Safe for Use on Cannabis?

Since the first plants to be quarantined after discoveries of improper, off­-label pesticide use to the most recent recalls, some of the Colorado cannabis companies caught up in those enforcement actions have made public statements claiming that their products are safe. These statements are dangerously misleading, as they do not take into account the issues laid out above, nor the facts that follow.

Frequently, attempts to justify such claims point out that pesticides are employed on our food and therefore must be okay to apply to cannabis as well. This is a classic case of comparing apples to oranges; or, in this case, comparing apples and oranges to cannabis. Such data cannot be bridged for the simple reason that apples and oranges (and most other agricultural food crops) are not smoked. Smoking remains the primary method of cannabis ingestion, but cannabis products are also vaporized (concentrates), consumed (edibles), applied to the skin (topical creams and patches), and taken sublingually (tinctures, sublingual strips).

As noted, the studies that pesticides must undergo prior to being approved by the EPA involve measuring acceptable residues based on the method of consumption of the final product. Since most food is consumed and digested, few pesticides on the market have undergone pyrolysis studies, which examine how the chemical structures of pesticides degrade when burned. This means that while the fungicide myclobutanil, the active ingredient in Eagle 20EW, may be approved for use on grapes, that approval is meaningless in regard to cannabis, as grapes are not smoked and the relative safety of myclobutanil residues was not tested in regard to such a consumption method.

While studies may eventually reveal that certain pesticides may be used on cannabis without ill effects to the end users, such research has not been performed and no one can say with certainty what the effects of consuming cannabis containing pesticide residues might be. Even the CDA qualifies the list of products that may be used without violating labeling guidelines with the following statement, “These products have not been tested to determine their health effects if used on marijuana that will be consumed and thus the health risks to consumers is unknown.”

Again, no one can currently say what pesticides, if any, can be safely employed on cannabis; anyone claiming definitively that their products are safe despite off­-label pesticide use is making a statement that at this time lacks any scientific basis whatsoever.

Another claim made numerous times by companies defending their off­-label pesticide use is that no one has yet fallen ill from pesticide use on cannabis. While this is true, we must remember that we are in uncharted territory, and no large­scale public health studies have been done to determine what, if any, effects result from consuming cannabis to which pesticides were applied. We hope that no ill effects will surface, but the fact of the matter is that chronic health issues may take years to show themselves and a public health crisis may yet emerge.

Recommendations for the Cannabis Industry

We are advocates for cannabis legalization and want to see this industry grow and develop into one that is beneficial for all involved. We believe that cannabis can continue to be a force for positive change in numerous areas of society, from medicine to criminal justice to agriculture, and beyond. But, in order for it to do so, we must navigate issues such as those around pesticide use in an intelligent and responsible manner.

Our primary recommendation should be preceded by the statement that the use of chemical pesticides of the type triggering Colorado’s recalls is not needed in cannabis production. We make this statement based on years of experience working in, managing, and advising cultivation operations of all types, methodologies, and scales on how to grow successfully without illegal pesticides. Cannabis has survived and flourished throughout human history without pesticides, and will continue to do so if we cultivate it correctly.

As such, we recommend that growers n​ot​ employ any pesticides in a manner that violates label directions, and only use 25(b) products that have undergone pyrolysis testing to ensure that they are not releasing harmful compounds when burned. Furthermore, applications should only be made during the vegetative stage, prior to the emergence of flowers. Overall, if there is any doubt as to whether a product or material is safe, it should not be used until legitimate, peer­-reviewed research has been performed by a reputable institution.

Successful pest control can be achieved via intelligent facility design, robust environmental controls, workflow protocols, and strict cleanliness standards, in addition to preventative applications of appropriate minimum­ risk pesticides. There is no magic bullet that will solve all pest problems, which is why experienced agricultural professionals rely on Integrated Pest Management (IPM), defined as “an ecosystem­-based strategy that focuses on long­term prevention of pests or their damage through a combination of techniques such as biological control, habitat manipulation, modification of cultural practices, and use of resistant varieties.” Overall, the adoption of Good Agricultural Practices (GAP) is much needed in the industry, and cannabis growers should look to agricultural operations that promote the four pillars of GAP standards (economic viability, environmental sustainability, social acceptability, and safety and quality of the final product) for guidance in formulating best practices in this new field.

This recommendation is not simply a matter of principle, but one that will preserve your business. In addition to costly and brand­-damaging recalls, we have already seen the first product liability lawsuits filed last year against LivWell by cannabis consumers over off­label pesticide use. Another issue is that of worker safety. Most cannabis cultivation takes place indoors, where pesticide residues can linger in garden areas and on equipment, creating toxic work environments. Unfortunately, based on the widespread nature of pesticide use in the legal cannabis industry, we feel confident in stating that thousands of workers employed in legal cannabis cultivation operations have applied chemical pesticides without proper PPE or safety training. Businesses employing pesticides off­-label will likely find themselves subject to liability claims from workers, as well as consumers, in the relatively near future.

Conclusion

In closing, the bottom line is that applying pesticides off­-label is a violation of state and federal law and could result in criminal and civil sanctions, should regulators and affected parties choose to pursue them.

It must also be noted that off­-label pesticide use threatens the industry as a whole. Point six of the Cole Memorandum states that the federal government will not make the enforcement of the Controlled Substances Act a priority as long as the “exacerbation of (…) public health consequences associated with marijuana use” is prevented. The emergence of a public health problem would be a violation of the Cole Memo ­and it could be argued that the current situation unfolding in Denver is already a violation ­ and could trigger federal intervention against states that have legalized cannabis. In this light, the Denver Department of Environmental Health, which is driving the recalls, has not “launched a campaign against legal cannabis,” as a company recently subject to a recall claimed, but is actually acting as a bulwark against a potentially serious Cole Memo violation that could shutter the entire industry.

Based on the current situation, the cannabis industry must come together to denounce and eliminate off­-label pesticide use. In order to ensure the health of patients, consumers, workers, and the industry itself, we must seize this opportunity to grow without chemicals that are currently illegal, potentially very harmful, and ultimately not even necessary.

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Pesticide Recalls an Ongoing Issue for Colorado

By Aaron G. Biros
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In the wake of investigations this summer in Oregon and Colorado, which found that numerous marijuana products contain levels of illegal pesticides, state regulators, laboratories, manufacturers, and cultivators alike are acting fast to minimize risks to consumers and patients. The largest recall ever to occur in the cannabis industry happened on October 30, when two companies in Denver found potential pesticide contamination in tens of thousands of packages of edible cannabis products.

As of now, it is difficult to find information available on pesticide use and flowering, its effect on the body through combustion and inhalation, and its effect on medical patients with already weakened immune systems. Research suggests up to 69.5% of pesticide residues can stay in marijuana smoke. Of course, there is a need for more research, but it is safe to accept that pesticides already banned for use on foods by the USDA or state departments should not be allowed in cannabis production.

In Colorado, “Nearly six months after the city of Denver began a crackdown on unapproved pesticides in marijuana products, a spot-check by The Denver Post found that the chemicals were still being sold to consumers.” This presents a major problem to an industry still trying to change public opinion for wider legalization efforts.

The Oregonian and OregonLive investigation found pesticides in most of the 10 marijuana concentrates that were screened. “Many of the pesticides detected aren’t regulated by Oregon’s medical marijuana rules, which means products that contain these chemicals still can be sold.”

While state regulations on pesticide use continue to get hammered out, the U.S. Department of Agriculture along with the U.S. Environmental Protection Agency is currently working on identifying pesticides that might be safe to use on cannabis. That guidance is crucial for any industry in order to establish safe levels of pesticides allowed, as well as which pesticides are more dangerous to the consumer than others.

Just last week, two of the largest recalls in the cannabis industry occurred in Colorado due to potential pesticide contamination. According to The Denver Post, as many as 30,000 packages of edibles produced by two companies were recalled by the Denver Department of Health.

Alex Garton, a cultivator in Michigan, agrees with many proponents of organic methods, citing the need for close management of the plants without pesticides. “The best way to avoid pests is to keep the grow room clean,” he says. “Mites will come and go, as will temperature and humidity issues, but without using pesticides, there are some safe, natural products that are very effective.”

“I treat my plants with natural compounds that are permitted under the federal government’s guidance for use in vegetable applications for human consumption,” Garton adds. “Never use anything remotely resembling a pesticide on flowers particularly when maturing and in the flowering process.”

Adam Jacques, master cultivator and owner of The Growers Guild in Eugene, Oregon, agrees with the sentiment of caution shared by many in the industry. “I would say, nationwide, there needs to be a more in depth look at pesticides, even organic strawberries can have [the pesticide] Eagle 20 on them,” he says. “With cannabis, we can’t scrub and wash pesticides off like fruit that you take off the vine, and there is a real lack of research on residues and combustion.”

Jacques tests all of his cannabis products for pesticides, molds, microbials and pathogens along with potency profiles, most of which is not required by the state. Growers should take lessons from Garton and Jacques by forgoing any application of pesticides until there is more confident state-level guidance on the dangers associated with pesticides on cannabis.