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Leaders in Cannabis Testing – Part 1: A Q&A with Milan Patel, CEO and Co-Founder of PathogenDx

By Aaron Green
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In this “Leaders in Cannabis Testing” series of articles, Green interviews cannabis testing laboratories and technology providers that are bringing unique perspectives to the industry. Particular attention is focused on how these businesses integrate innovative practices and technologies to navigate a rapidly changing landscape of regulatory constraints and B2B demand.

PathogenDx is an Arizona-based provider of microbial testing technologies. Since their inception in 2014, they have broadened their reach to 26 states in the US. In addition to cannabis product testing, PathogenDx also provides technologies for food safety testing, environmental testing and recently started offering human diagnostics testing to support COVID-19 response efforts.

We interviewed Milan Patel, CEO and co-founder of PathogenDx. Milan founded PathogenDx as a spin-off from one of his investments in a clinical diagnostics company testing for genetic markers in transplant organs. Prior to PathogenDx, Milan worked in finance and marketing at Intel and later served as CFO at Acentia (now Maximus Federal).

Aaron Green: What’s the history of PathogenDx?

Milan Patel: PathogenDx was effectively a spin-off of a clinical diagnostics company that my partner Dr. Mike Hogan, the inventor of the technology, had founded when he was a professor at the University of Arizona, but previously at Baylor Medical College back in 2002. I had invested in the company back then and I had realized that his technology had a broad and wide sweeping impact for testing – not just for pathogens in cannabis specifically, but also for pathogens in food, agriculture, water and even human diagnostics. In the last 14 months, this became very personal for every single person on the planet having been impacted by SARS-CoV-2, the viral pathogen causing Covid-19. The genesis of the company was just this, that human health, food and agricultural supply, and the environment has and will continue to be targeted by bacterial, fungal and viral pathogens impacting the safety and health of each human on the planet.

We founded PathogenDx and we pivoted the company from its original human organ transplant genetics market scope into the bigger markets; we felt the original focus was too niche for a technology with this much potential. We licensed the technology, and we repurposed it into primarily cannabis. We felt that achieving commercial success and use in the hands of cannabis testing labs at the state level where cannabis was first regulated was the most logical next step. Ultimately, our goal was and is to move into markets that are approved at the federal regulatory side of the spectrum, and that is where we are now.

Green: What year was that?

Milan Patel, CEO and Co-Founder of PathogenDx
Photo credit: Michael Chansley

Patel: 2014.

Green: So, PathogenDx started in cannabis testing?

Patel: Yes, we started in cannabis testing. We now have over 100 labs that are using the technology. There is a specific need in cannabis when you’re looking at contamination or infection.

In the case of contamination on cannabis, you must look for bacterial and fungal organisms that make it unsafe, such as E. coli, or Salmonella or Aspergillus pathogens. We’re familiar with recent issues like the romaine lettuce foodborne illness outbreaks at Chipotle. In the case of fungal organisms such as Aspergillus, if you smoke or consume contaminated cannabis, it could have a huge impact on your health. Cannabis regulators realized that to ensure public health and safety there was more than just one pathogen – there were half a dozen of these bugs, at a minimum, that could be harmful to you.

The beauty of our technology, using a Microarray is that we can do what is called a multiplex test, which means you’re able to test for all bacterial and fungal pathogens in a single test, as opposed to the old “Adam Smith” model, which tests each pathogen on a one-by-one basis. The traditional approach is costly, time consuming and cumbersome. Cannabis is such a high value crop and producers need to get the answer quickly. Our tests can give a result in six hours on the same day, as opposed to the two or three days that it takes for these other approved methods on the market.

Green: What is your business model? Is there equipment in addition to consumables?

Patel: Our business model is the classic razor blade model. What that means is we sell equipment as well as the consumables – the testing kits themselves.

The PathogenDx technology uses standard, off-the-shelf lab equipment that you can find anywhere. We didn’t want to make the equipment proprietary so that a lab has to buy a specific OEM branded product. They can use almost any equipment that’s available commercially. We wanted to make sure that labs are only paying a fraction of the cost to get our equipment, as opposed to using other vendors. Secondly, the platform is open-ended, meaning it’s highly flexible to work with the volumes that different cannabis labs see daily, from high to low.

One equipment set can process many different types of testing kits. There are kits for regulated testing required by states, as well as required environmental contamination.

Green: Do you provide any in-house or reference lab testing?

Patel: We do. We have a CLIA lab for clinical testing. We did this about a year ago when we started doing COVID testing.

We don’t do any kind of in-house reference testing for cannabis, though we do use specific reference materials or standards from Emerald Scientific, for example, or from NCI. Our platform is all externally third-party reference lab tested whether it’s validated by our external cannabis lab customers or an independent lab. We want our customers to make sure that the actual test works in their own hands, in their own facility by their own people, as opposed to just shrugging our shoulders and saying, “hey, we’ve done it ourselves, believe us.” That’s the difference.

Green: Can you explain the difference between qPCR and endpoint PCR?

Patel: The difference between PathogenDx’s Microarray is it uses endpoint PCR versus qPCR (quantitative real time PCR). Effectively, our test doesn’t need to be enriched. Endpoint PCR delivers a higher level of accuracy, because when it goes to amplify that target DNA, whether it’s E. coli, Salmonella or Aspergillus pieces, it uses all the primer reagent to its endpoint. So, it amplifies every single piece of an E. Coli (for example) in that sample until the primer is fully consumed. In the case of qPCR, it basically reaches a threshold and then the reaction stops. That’s the difference which results in a much greater level of accuracy. This provides almost 10 times greater sensitivity to identify the pathogen in that sample.

The second thing is that we have separated out how the amplified sample hybridizes to the probe. In the case of our assay, we have a microarray with a well in it and we printed the actual probe that has the sequence of E. coli in there, now driving 100% specificity. Whereas in the qPCR, the reaction is not only amplifying, but it’s also basically working with the probe. So, in that way, we have a higher level of efficiency in terms of specificity. You get a definite answer exactly in terms of the organism you’re looking for.

In terms of an analogy, let’s take a zip code for example which has the extra four digits at the end of it.  In the case of endpoint PCR, we have nine digits. We have our primer probes which represent the standard five digits of a zip code, and the physical location of the probe itself in the well which serves as the extra four digits of that zip code. The analyte must match both primary and secondary parts of the nine-digit zip code for it to lock in, like a key and a lock. And that’s the way our technology works in a nutshell.

Endpoint PCR is completely different. It drives higher levels of accuracy and specificity while reducing the turnaround time compared to qPCR – down to six hours from sample to result. In qPCR, you must enrich the sample for 24 to 48 hours, depending on bacteria or fungus, and then amplification and PCR analysis can be done in one to three hours. The accuracies and the turnaround times are the major differences between the endpoint PCR and qPCR.

Green: If I understand correctly, it’s a printed microarray in the well plate?

Patel: That’s correct. It’s a 96-well plate, and in each well, you’ve now printed all the probes for all targets in a single well. So, you’re not running more than one well per target, or per organism like you are for qPCR. You’re running just one well for all organisms. With our well plates, you’re consuming fewer wells and our patented foil-cover, you only use the wells you need. The unused wells in the well plate can be used in future tests, saving on costs and labor.

Green: Do you have any other differentiating IP?

The PathogenDx Microarray

Patel: The multiplex is the core IP. The way we process the raw sample, whether it’s flower or non-flower, without the need for enrichment is another part of the core IP. We do triplicate probes in each well for E. Coli, triplicate probes for Salmonella, etc., so there are three probes per targeted organism in each of the wells. We’re triple checking that you’re definitively identifying that bug at the end of the day. This is the cornerstone of our technology.

We were just approved by the State of New York, and the New York Department of Health has 13 different organisms for testing on cannabis. Think about it: one of the most rigorous testing requirements at a state level – maybe even at a federal level – and we just got approved for that. If you had to do 13 organisms separately, whether it’s plate culture or qPCR, it would become super expensive and very difficult. It would break the very backs of every testing lab to do that. That’s where the multiplexing becomes tremendously valuable because what you’re doing is leveraging the ability to do everything as a single test and single reaction.

Green: You mentioned New York. What other geographies are you active in?

Patel: We’re active in 26 different states including the major cannabis players: Florida, Nevada, California, Arizona, Michigan, New York, Oklahoma, Colorado and Washington – and we’re also in Canada. We’re currently working to enter other markets, but it all comes down to navigating the regulatory process and getting approval.

We’re not active currently in other international markets yet. We’re currently going through the AOAC approval process for our technology and I’m happy to say that we’re close to getting that in the next couple of months. Beyond that, I think we’ll scale more internationally.

I am delighted to say that we also got FDA EUA federal level authorization of our technology which drives significant credibility and confidence for the use of the technology. About a year ago, we made a conscious choice to make this technology federally acceptable by going into the COVID testing market. We got the FDA EUA back on April 20, ironically. That vote of confidence by the FDA means that our technology is capable of human testing. That has helped to create some runway in terms of getting federalized with both the FDA and the USDA, and certification by AOAC for our different tests.

Green: Was that COVID-19 EUA for clinical diagnostics or surveillance?

Patel: It was for clinical diagnostics, so it’s an actual human diagnostic test.

Green: Last couple of questions here. Once you find something as a cannabis operator, whether its bacteria or fungus, what can you do?

Patel: There are many services that are tied into our ecosystem. For example, we work with Willow Industries, who does remediation.

There’s been a lot of criticism around DNA based technology. It doesn’t matter if it’s qPCR or endpoint PCR. They say, “well, you’re also including dead organisms, dead DNA.” We do have a component of separating live versus dead DNA with a biomechanical process, using an enzyme that we’ve created, and it’s available commercially. Labs can test for whether a pathogen is living or dead and, in many cases, when they find it, they can partner with remediation companies to help address the issue at the grower level.

Another product we offer is an EnviroX test, which is an environmental test of air and surfaces. These have 50 pathogens in a single well. Think about this: these are all the bad actors that typically grow where soil is – the human pathogens, plant pathogens, powdery mildew, Botrytis, Fusarium – these are very problematic for the thousands of growers out there. The idea is to help them with screening technology before samples are pulled off the canopy and go to a regulated lab. We can help the growers isolate where that contamination is in that facility, then the remediation companies can come in, and help them save their crop and avoid economic losses.

Green: What are you most interested in learning about?

Patel: I would prefer that the cannabis industry not go through the same mistakes other industries have gone through. Cannabis started as a cottage industry. It’s obviously doubled every year, and as it gets scaled, the big corporations come in. Sophistication, standards, maturity all help in legitimacy of a business and image of an industry. At the end of the day, we have an opportunity to learn from other industries to really leapfrog and not have to go through the same mistakes. That’s one of the things that’s important to me. I’m very passionate about it.

One thing that I’ll leave you with is this: we’re dealing with more bugs in cannabis than the food industry. The food industry is only dealing with two to four bugs and look at the number of recalls they are navigating – and this is a multi-billion-dollar industry. Cannabis is still a fraction of that and we’re dealing with more bugs. We want to look ahead and avoid these recalls. How do you avoid some of the challenges around antimicrobial resistance and antibiotic resistance? We don’t want to be going down that road if we can avoid it and that’s sort of a personal mission for myself and the company.

Cannabis itself is so powerful, both medicinally as well as recreationally, and it can be beneficial for both consumers and industry image if we do the right things, and avoid future disasters, like the vaping crisis we went through 18 months ago because of bad GMPs. We must learn from those industries. We’re trying to make it better for the right reasons and that’s what’s important to me.

Green: Okay, great. That concludes the interview. Thank you, Milan.

Patel: Thank you for allowing me to share my thoughts and your time, Aaron.

The Power of Prevention: Pathogen Monitoring in Cannabis Cultivation and Processing Facilities

By Nathan Libbey
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As the cannabis market matures and the value chain becomes modernized, it’s important to address product safety in a comprehensive way. In other areas of manufacturing, Hazard Analysis & Critical Control Points (HACCP) has been the standard for reducing hazards both for employees and for the products themselves. A Critical Control Point (CCP) is any spot from conception to consumption where a loss of control can potentially result in risk (Unnevehr, 1996). In the food realm, HACCP has been used to drive quality enhancements since the 1980s (Cichy, 1982).

In a nutshell, HACCP seeks to help identify where a problem may enter a product or environment and how that problem may be addressed before it escalates. In cannabis, these hazards include many of the same problems that food products have: specifically molds, yeasts, and pathogenic bacteria (Listeria, E. coli, etc.). While the current industry standard is to test products at the end stage for these contaminants, this late-stage pass/fail regimen leads to huge lots of destroyed product and a risk for consumer distrust (Yamashiro, 2019). HACCP, therefore, should be applied at every stage of the production process.

Pathogen Environmental Monitoring (PEM) is a tool that can be used to identify CCPs in a cannabis cultivation or processing facility. The main goal of a PEM program is to find a contaminant before it reaches a surface that touches the product or the product itself. PEM is conducted using a pre-moistened swab or a sponge to collect a sample from the cannabis environment. The swab can then be sent to a lab for microbial testing. Keys to an effective PEM are:

1. Start with a broad stroke – When the FDA comes to a facility suspected of producing pathogen-laced food products, they conduct what is known as a Swab-a-thon. A Swab-a-thon is a top to bottom collection of samples, usually totaling 100 or more. Similarly, preemptively swabbing should be the first step in any PEM—swab everything to see what exists as a baseline.

2. Map your scene – identify on a map of your facility the following:

  • Cannabis contact surfaces (CCS) (belts, clippers, tables, etc)
  • Non-cannabis contact surfaces (Non-CCS) (floors, lighting, drains, etc)
  • Flow of air and people (where do air and people enter and where do they go?

Identifying the above zones will help deepen your understanding of where contaminants may come into contact with cannabis and how they may migrate from a Non-CCS to a CCS. 

3. Plan and execute:

  • Based on the results of mapping, and Swab-a-thon, identify where and when you will be collecting samples on a consistent and repeatable basis. Emphasis should be placed on areas that are deemed a risk based on 1) and 2). Samples should be collected at random in all zones to ensure comprehensive screening.

4. Remediate and modify:

  • If you get a positive result during PEM, don’t panic—pathogens are ubiquitous.
  • Remediate any trouble spots with deep cleaning, remediation devices or other protocols.
  • Re-test areas that were positive for pathogens to ensure remediation is successful.
  • Revisit and modify the plan at least once a year and each time a new piece of equipment is added or production flow is otherwise changed.

The steps above are a good starting point for a grower or processor to begin a PEM. Remember that this is not a one-size-fits-all approach to safety; each facility has its own unique set of hazards and control points.

Comprehensive guides for PEM can be found at the links below, many of the concepts can be applied to cannabis production.


https://affifoodsafety.org/lcp/advanced-search/

http://www.centerforproducesafety.org/amass/documents/document/263/Listeria%20Guidance%20UFPA%202013.pdf

Cichy, R. (1982). HACCP as a quality assurance tool in a commissary food-service system. International Journal of Hospitality Management, 1(2), 103-106.

Unnevehr, L., & Jensen, H. (1996). HACCP as a Regulatory Innovation to Improve Food Safety in the Meat Industry. American Journal of Agricultural Economics, 78(3), 764-769.

Yamashiro, C, & Baca, Y. (2019).  Prevent high-value cannabis crop loss with innovative environmental monitoring tool.

Soapbox

3 Food Safety Precautions for Edibles

By Cindy Rice
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You’ve survived seasons of cannabis cultivations, bringing in quality plants in spite of mold, mites, drought and other challenges that had to be conquered. Extraction methods are sometimes challenging, but you are proud to have a cannabinoid extract that can be added into your own products for sale. Edibles are just waiting to be infused with the cannabinoids, for consumers demanding brownies, gummies, tinctures and almost any food and beverage imaginable. You’ve been through the fire, and now the rest is easy peasy, right?

Food processing and sanitation
Avoiding cross contamination should be a priority for edibles manufacturing

Actually, producing edibles may not be so seamless as you think. Just as in the rest of the food industry, food safety practices have to be considered when you’re producing edibles for public consumption, regardless of the THC, CBD, terpene or cannabinoid profile. Once you’ve acquired the extract (a “food grade ingredient”) containing the active compounds, there are three types of hazards that could still contribute to foodborne illness from your final product if you’re not careful- Biological, Chemical and Physical.

Biological hazards include pathogenic bacteria, viruses, mold, mildew (and the toxins that they can produce) that can come in ingredients naturally or contaminate foods from an outside source. Chemical hazards are often present in the kitchen environment, including detergents, floor cleaners, disinfectants and caustic chemicals, which can be harmful if ingested- they are not destroyed through cooking. Physical objects abound in food production facilities, including plastic bits, metal fragments from equipment, staples or twist ties from ingredient packages, and personal objects (e.g., buttons, jewelry, hair, nails.)

There are three main safety precautions that can help control these hazards during all the stages of food production, from receiving ingredients to packaging your final products:

1. Avoid Cross Contamination

  • Prevent biological, chemical or physical hazards from coming into contact with foods
  • Keep equipment, utensils and work surfaces clean and sanitized.
  • Prevent raw foods (as they usually carry bacteria) from coming into contact with “Ready-to-eat” foods (foods that will not be cooked further before consuming).
  • Keep chemicals away from food areas.

2. Personal Hygiene

  • Don’t work around foods if you’re sick with fever, vomiting or diarrhea. These could be signs of contagious illness and can contaminate foods or other staff, and contribute to an outbreak.
  • Do not handle ready-to-eat foods with bare hands, but use a barrier such as utensils, tissues or gloves when handling final products such as pastries or candies.
  • Wash hands and change gloves when soiled or contaminated.
  • Wear hair restraints and clean uniforms, and remove jewelry from hands and arms.

3. Time & Temperature control

  • Prevent bacterial growth in perishable foods such as eggs, dairy, meats, chicken (TCS “Time and Temperature Control for Safety” foods according to the FDA Model Food Code) by keeping cold foods cold and hot foods hot.
  • Refrigerate TCS foods at 41˚ F or below, and cook TCS foods to proper internal temperatures to kill bacteria to safe levels, per state regulations for retail food establishments.
  • If TCS foods have been exposed to room temperature for longer than four hours (Temperature Danger Zone 41˚ F – 135˚ F,) these foods should be discarded, as bacteria could have grown to dangerous levels during this time.

As cannabis companies strive for acceptance and legalization on a federal level, adopting these food safety practices and staff training is a major step in the right direction, on par with standards maintained by the rest of the retail food industry. The only difference is your one specially extracted cannabinoid ingredient that separates you from the rest of the crowd… with safe and healthy edibles for all.

Cannabusiness Sustainability

Designing More Sustainable Cannabis Facilities

By Sophia Daukus
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The topic of sustainability has grown in importance and priority for both consumers and regulators. From reducing emissions to lowering energy and water consumption, cannabis growing facilities face unique challenges when it comes to designing sustainable operations. Moreover, as the cannabis market grows and usage becomes more accepted, regulatory bodies will continue to increase the number of directives to help ensure the safety and quality of cannabis products.

Non-porous flooring options are impervious in nature, helping to isolate contaminants on the surface, thus enabling proper cleanup and disposal.

Ubiquitous throughout cannabis grow rooms and greenhouses, flooring can be easily overlooked, yet offers an economical way to create more sustainable facilities. Many of today’s grow rooms are located in old retrofitted warehouses or former industrial buildings that were designed without sustainability or environmental concerns in mind.

Combined with energy efficient lighting and more thoughtful water usage, flooring can help create a more efficient facility that not only improves business operations, but also contributes to a better bottom line.

Sustainability Challenges Facing Cannabis Facilities

Whether in an old warehouse space or a new structure designed from the ground up, cannabis businesses face unique operational challenges when it comes to sustainable best practices.

  • Energy Consumption: Like any indoor farm, lighting plays an important role in cannabis growing facilities. Traditional grow lights can utilize a large amount of electricity, putting a strain on the company budget as well as regional energy resources. Switching to highly-efficient LED lighting can help facilities reduce their consumption, while still maximizing crop yield.
  • Water Consumption: Among the thirstiest of flora, cannabis plants require consistent and plentiful watering for healthy and fruitful crop production.
  • Carbon Dioxide (CO2) Enrichment: In many cases, carbon dioxide is introduced into facilities to help enhance the growth of crops. However, this practice may pose safety and health risks for workers, the surrounding community and the planet at large. CO2 is a greenhouse gas known to contribute to climate change.

In order to head off upcoming regulatory restrictions, as well as to alleviate the mounting safety and health concerns, it behooves cannabis grow room managers and owners to explore alternatives for improving sustainability in their facilities.

Flooring Requirements for More Sustainable Cannabis Facilities

Spanning thousands or even hundreds of thousands of square feet throughout a facility, flooring can be a unique way to introduce and support sustainable practices in any grow room or greenhouse.

When seeking to improve operational efficiency and implementing the use of sustainable practices in cannabis facilities, look for flooring systems with the following characteristics:

  • Impervious Surfaces— Fertilizers, fungicides, and other chemicals can infiltrate porous unprotected concrete to leach through the slab matrix and into the soil and groundwater below. Non-porous flooring options, such as industrial-grade, fluid-applied epoxies and urethanes, are impervious in nature, helping to isolate contaminants on the surface, thus enabling proper cleanup and disposal.
  • Light-Reflective Finishes— Light-colored white or pastel floor surfaces in glossy finishes can help reduce the amount of energy needed to properly illuminate grow rooms. By mirroring overhead lighting back upward, bright, light-reflective flooring can help minimize facilities’ reliance on expensive ceiling fixtures and electricity usage.
  • USDA, FDA, EPA, OSHA and ADA Compliancy— With cannabis industry regulations currently in flux, grow facilities that select food- and pharmaceutical-compliant flooring will be ahead of the game. Governing bodies in some states have already begun expanding the facility requirements of these sectors to the cannabis market.
  • Durable and Easy Care— Having to replace flooring every couple of years imposes high costs on businesses as well as the environment. Installation of many traditional types of flooring produces cut-off waste and requires landfill disposal of the old floor material. In contrast, by installing industrial-grade flooring systems that are highly durable and easy-to-maintain, facilities can count on long-term performance and value, while helping to minimize disposal costs and concerns.
Light-colored white or pastel floor surfaces in glossy finishes can help reduce the amount of energy needed to properly illuminate grow rooms.

Optimal flooring can help cultivation facilities reduce waste, improve the efficacy of existing lighting and lengthen floor replacement cycles for a better bottom line and a healthier environment. Additionally, having the right grow room floor can assist facilities in meeting regulatory requirements, help ensure production of quality products and improve the safety for consumers and staff.

Flooring Benefits for Employees and Consumers

Safety is paramount in any workplace. When it comes to the manufacture of foodstuffs and other consumed products, government oversight can be especially stringent. With the right compliant flooring in place, cultivation facilities can focus on the rest of their business, knowing that what’s underfoot is contributing to the safety of employees and their customers.

Here’s how:

  • Chemical Resistance— Floors can be exposed to a high concentration of chemicals, acids and alkalis in the form of fertilizers, soil enhancers and other substances. In processing locations, the proper disinfecting and sanitizing of equipment can require harsh solvents, detergents and chemical solutions, which can drip or spill onto the floor, damaging traditional flooring materials. It pays to select cannabis facility flooring with high chemical resistance to help ensure floors can perform as designed over the long term.
  • Thermal Shock Resistance— Optimal cannabis facility flooring should be capable of withstanding repeated temperature cycling. Slab-on-grade structures in colder climates may be especially vulnerable to floor damage caused by drastic temperature differences between a freezing cold concrete slab and the tropical grow room above. This extreme contrast can cause certain floor materials to crack, delaminate and curl away from the concrete substrate. The resulting crevices and uneven surfaces present trip and fall hazards to employees and leave the slab unprotected from further degradation. As an alternative, thermal shock-resistant floors, such as urethane mortar systems, furnish long-lived functionality even when regularly exposed to extreme temperature swings.
  • Humidity and Moisture Resistance— Traditional floor surfaces tend to break down in ongoing damp, humid environments. Cannabis facility flooring must be capable of withstanding this stress and more.
  • Pathogen Resistance— Undesirable microbes, fungi and bacteria can thrive in the moist, warm environments found in grow rooms. Floors with extensive grout lines and gaps provide additional dark, damp locations for pathogen growth. Fluid-applied flooring results in a virtually seamless surface that’s directly bonded to the concrete. Integral floor-to-wall cove bases can further improve wash down and sanitation.
  • Proper Slope and Drainage— Where food and/or pharmaceutical facility regulations have already been extended to cannabis operations, flooring is required to slope properly toward a floor drain. This prevents puddling, which can be a slip hazard as well as a microbe breeding ground. Unlike more typical materials, resinous flooring offers an economical solution for correcting floor slope wherever needed.

The Problems Presented by Traditional Flooring Options

Previously, cannabis growers often relied on traditional greenhouse-type flooring, including tamped down dirt floors, gravel or bare concrete. However, current and upcoming regulations are curtailing the use of these simple flooring options.

Growers often compare and contrast the benefits and value of traditional greenhouse flooring with more modern solutions, such as fluid-applied epoxy and urethane floors.

Dirt and gravel flooring offers little opportunity to properly sanitize, thus potentially inviting microorganism and pathogen invasion, contamination and costly damage. Growers who have turned to bare concrete floors face other concerns, including:

  • Unprotected concrete is inherently porous and therefore able to quickly absorb spilled liquids and moisture from the air. In addition, organic and synthetic fertilizers, fungicides, and chemicals can leach through the concrete floors, contaminating the groundwater, injuring the surrounding environment and wildlife.
  • Older slabs often lack an under-slab vapor barrier. Even in new construction, a single nail hole can render an under-slab barrier ineffective. In these situations, moisture from underneath the floor slab can move upward osmotically through the alkaline slab, leading to blistering and damage to standard commercial floor coverings.
  • Bare concrete floors can stain easily. These dark stains tend to absorb light instead of reflecting it, contributing to a potential increase in energy usage and cost.
  • The mold proliferation encouraged by the warmth and humidity of grow rooms can easily penetrate into the depths of unprotected slab surfaces, eventually damaging its structural integrity and shortening the usable life of the concrete.

While traditional greenhouse flooring options can initially seem less expensive, they frequently present long-term risks to the health of cannabis grow businesses. In addition, the performance of dirt, gravel and bare concrete floors runs counter to the industry’s commitment to reducing the carbon footprint of growing facilities.

Choosing Sustainable Grow Room Flooring

It’s no secret that the cannabis industry is undergoing enormous change and faces numerous environmental challenges. Luckily, optimal flooring options are now available to help growers economically increase their eco-friendly practices on many fronts. By focusing on quality resinous flooring, cannabis growers can get closer to meeting their sustainability goals, while simultaneously contributing to improved operation efficiency, enhanced yields and an increased bottom line.

The Best Way to Remediate Moldy Cannabis is No Remediation at All

By Ingo Mueller
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Consumers are largely unaware that most commercial cannabis grown today undergoes some form of decontamination to treat the industry’s growing problem of mold, yeast and other microbial pathogens. As more cannabis brands fail regulatory testing for contaminants, businesses are increasingly turning to radiation, ozone gas, hydrogen peroxide or other damaging remediation methods to ensure compliance and avoid product recalls. It has made cannabis cultivation and extraction more challenging and more expensive than ever, not to mention inflaming the industry’s ongoing supply problem.

The problem is only going to get worse as states like Nevada and California are beginning to implement more regulations including even tougher microbial contamination limits. The technological and economic burdens are becoming too much for some cultivators, driving some of them out of business. It’s also putting an even greater strain on them to meet product demand.

It’s critical that the industry establishes new product standards to reassure consumers that the cannabis products they buy are safe. But it is even more critical that the industry look beyond traditional agricultural remediation methods to solve the microbial problems.

Compounding Risks

Mold and other microbial pathogens are found everywhere in the environment, including the air, food and water that people consume. While there is no consensus yet on the health consequences of consuming these contaminants through cannabis, risks are certainly emerging. According to a 2015 study by the Cannabis Safety Institutei, molds are generally harmless in the environment, but some may present a health threat when inhaled, particularly to immunocompromised individuals. Mycotoxins resulting from molds such as Aspergillus can cause illnesses such as allergic bronchopulmonary aspergillosis. Even when killed with treatment, the dead pathogens could trigger allergies or asthma.

Photo credit: Steep Hill- a petri dish of mold growth from tested cannabis

There is an abundance of pathogens that can affect cannabis cultivation, but the most common types are Botrytis (bud rot, sometimes called gray mold) and Powdery Mildew. They are also among the most devastating blights to cannabis crops. Numerous chemical controls are available to help prevent or stem an outbreak, ranging from fungicides and horticultural oils to bicarbonates and biological controls. While these controls may save an otherwise doomed crop, they introduce their own potential health risks through the overexposure and consumption of chemical residues.

The issue is further compounded by the fact that the states in which cannabis is legal can’t agree on which microbial pathogens to test for, nor how to test. Colorado, for instance, requires only three pathogen tests (for salmonella, E. coli, and mycotoxins from mold), while Massachusetts has exceedingly strict testing regulations for clean products. Massachusetts-based testing lab, ProVerde Laboratories, reports that approximately 30% of the cannabis flowers it tests have some kind of mold or yeast contamination.

If a cannabis product fails required microbial testing and can’t be remedied in a compliant way, the grower will inevitably experience a severe – and potentially crippling – financial hit to a lost crop. Willow Industries, a microbial remediation company, says that cannabis microbial contamination is projected to be a $3 billion problem by 2020ii.

Remediation Falls Short
With the financial stakes so high, the cannabis industry has taken cues from the food industry and adopted a variety of ways to remediate cannabis harvests contaminated with pathogens. Ketch DeGabrielle of Qloris Consulting spent two years studying cannabis microbial remediation methods and summarized their pros and consiii.

He found that some common sterilization approaches like autoclaves, steam and dry heat are impractical for cannabis due the decarboxylation and harsh damage they inflict on the product. Some growers spray or immerse cannabis flowers in hydrogen peroxide, but the resulting moisture can actually cause more spores to germinate, while the chemical reduces the terpene content in the flowers.

Powdery mildew starts with white/grey spots seen on the upper leaves surface

The more favored, technologically advanced remediation approaches include ozone or similar gas treatment, which is relatively inexpensive and treats the entire plant. However, it’s difficult to gas products on a large scale, and gas results in terpene loss. Microwaves can kill pathogens effectively through cellular rupture, but can burn the product. Ionizing radiation kills microbial life by destroying their DNA, but the process can create carcinogenic chemical compounds and harmful free radicals. Radio frequency (which DeGabrielle considers the best method) effectively kills yeast and mold by oscillating the water in them, but it can result in moisture and terpene loss.

The bottom line: no remediation method is perfect. Prevention of microbial contamination is a better approach. But all three conventional approaches to cannabis cultivation – outdoors, greenhouses and indoor grow operations – make it extremely difficult to control contamination. Mold spores can easily gain a foothold both indoors and out through air, water, food and human contact, quickly spreading into an epidemic.

The industry needs to establish new quality standards for product purity and employ new growing practices to meet them. Advanced technologies can help create near perfect growing ecosystems and microclimates for growing cannabis free of mold contamination. Internet of Things sensors combined with AI-driven robotics and automation can dramatically reduce human intervention in the growing process, along with human-induced contamination. Natural sunlight supplemented with new lighting technologies that provide near full-light and UV spectrum can stimulate robust growth more resistant to disease. Computational fluid dynamic models can help growers achieve optimal temperature, humidity, velocity, filtration and sanitation of air flow. And tissue culture micropropagation of plant stock can eliminate virus and pathogen threats, to name just a few of the latest innovations.

Growing legal cannabis today is a risky business that can cost growers millions of dollars if pathogens contaminate a crop. Remediation methods to remove microbial contamination may work to varying degrees, but they introduce another set of problems that can impact consumer health and comprise product quality.


References

i. Holmes M, Vyas JM, Steinbach W, McPartland J. 2015. Microbiological Safety Testing of Cannabis. Cannabis Safety Institute. http://cannabissafetyinstitute.org/wp-content/uploads/2015/06/Microbiological-Safety-Testing-of-Cannabis.pdf

ii. Jill Ellsworth, June 2019, Eliminating Microbials in Marijuana, Willow Industries, https://willowindustries.com/eliminating-microbials-in-marijuana/#

iii. Ketch DeGabrielle, April 2018, Largest U.S. Cannabis Farm Shares Two Years of Mold Remediation Research, Analytical Cannabis, https://www.analyticalcannabis.com/articles/largest-us-cannabis-farm-shares-two-years-of-mold-remediation-research-299842

 

Arizona Still Doesn’t Require Lab Testing, But That Could Change Soon

By Aaron G. Biros
2 Comments

As of today, Arizona is the only state in the country that has legalized medical cannabis but does not require producers to test their medical cannabis. States throughout the country that legalize medical cannabis routinely implement regulations that require third-party, independent lab testing to protect patient and consumer safety. Arizona legalized medical cannabis for a number of qualifying conditions back in 2011, but still has no measure like other states to protect patient safety.

Lawmakers in Arizona now have the opportunity to change that with SB1494, which passed unanimously through the state’s Senate back in March of 2019. According to the Arizona Cannabis Laboratory Association (ACLA), the bill awaits action in the House of Representatives. The ACLA says in a press release that “supporters of the bill are calling on lawmakers to move on a bill that unanimously passed in the Senate earlier this year.” The bill would require producers to use independent, third-party labs to test cannabis for things like harmful toxins and molds.

Ryan Tracy, co-founder of the ACLA and founder/CEO at C4 Labs.

According to Ryan Treacy, co-founder of the ACLA and CEO/Founder of C4 Laboratories, the ACLA was formed for a few important reasons: “We feel it is very important that we encourage and cultivate a professional and collaborative rapport among the reputable Arizona cannabis labs,” says Treacy. “So that we can call upon the collective groups’ years of experience to help provide insight and suggestions on how we as a group can insure the most accurate and consistent results for our clients throughout the state and ultimately their patients.” Treacy went on to add that it is particularly important their collective voice be heard at the State Capitol as lawmakers work towards passing SB 1494.

“There isn’t any reason to wait for someone to get sick before the legislature passes this bipartisan bill. Let’s get it done!”George Griffeth, President of the ACLA, says there is a sense of urgency in passing this bill before the voters decide on legalizing recreational adult-use cannabis next year. “Everyone agrees that now is the time to be proactive to protect patients from unsafe contaminants,” says Griffeth. “Currently 61 tons of medical marijuana is consumed by patients and many believe that the number of people using the medicine will continue to grow. With a ballot initiative related to the recreational use of marijuana facing voters next year, Arizona must act now to make sure standards are in place.”

They say the bill has bipartisan support and many stakeholders in Arizona’s cannabis industry express support for it as well. For Ryan Treacy, he is worried about patients consuming harmful chemicals and toxins. “My colleagues and I are deeply concerned that more than two-hundred thousand people who use medical marijuana could be inadvertently exposing themselves to toxic chemicals, E. Coli, Salmonella or mold,” says Treacy. “There isn’t any reason to wait for someone to get sick before the legislature passes this bipartisan bill. Let’s get it done!”

Treacy says this bill is particularly difficult to pass because the original measure to legalize medical cannabis was a ballot initiative. That means the bill needs 75% support in both the House and the Senate in order to amend the original measure. “The passing of this bill would be a huge win for the patients and will help to ensure honesty and transparency for those that operate in the current medical cannabis program here in AZ,” says Treacy. “This testing bill is also written with legislative intent to cover any and all future adult use or recreational use legislative laws or ballot initiatives. We hope to have a final verdict on this bill by end of this week or early next.”

HACCP

Implementing a HACCP Plan to Address Audit Concerns in the Infused Market

By Daniel Erickson
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HACCP

The increasing appeal and public acceptance of medical and recreational cannabis has increased the focus on the possible food safety hazards of cannabis-infused products. Foodborne illnesses from edible consumption have become more commonplace, causing auditors to focus on the various stages of the supply chain to ensure that companies are identifying and mitigating risks throughout their operations. Hazard Analysis and Critical Control Points (HACCP) plans developed and monitored within a cannabis ERP software solution play an essential role in reducing common hazards in a market currently lacking federal regulation.

What are cannabis-infused products?

Cannabis infusions come in a variety of forms including edibles (food and beverages), tinctures (drops applied in the mouth), sprays (applied under the tongue), powders (dissolved into liquids) and inhalers. Manufacturing of these products resembles farm-to-fork manufacturing processes common in the food and beverage industry, in which best practices for compliance with food safety regulations have been established. Anticipated regulations in the seed-to-sale marketplace and consumer expectations are driving cannabis infused product manufacturers to adopt safety initiatives to address audit concerns.

What are auditors targeting in the cannabis space?

The cannabis auditing landscape encompasses several areas of focus to ensure companies have standard operating procedures (SOP’s) in place. These areas include:

  • Regulatory compliance – meeting state and local jurisdictional requirements
  • Storage and product release – identifying, storing and securing products properly
  • Seed-to-sale traceability –  lot numbers and plant identifiers
  • Product development – including risk analysis and release
  • Accurate labeling –  allergen statements and potency
  • Product sampling – pathogenic indicator and heavy metal testing
  • Water and air quality –  accounting for residual solvents, yeasts and mold
  • Pest control – pesticides and contamination

In addition, auditors commonly access the reliability of suppliers, quality of ingredients, sanitary handling of materials, cleanliness of facilities, product testing and cross-contamination concerns in the food and beverage industry, making these also important in cannabis manufacturers’ safety plans.

How a HACCP plan can help

HACCPWhether you are cultivating, harvesting, extracting or infusing cannabis into edible products, it is important to engage in proactive measures in hazard management, which include a HACCP plan developed by a company’s safety team. A HACCP plan provides effective procedures that protect consumers from hazards inherent in the production and distribution of cannabis-infused products – including biological, chemical and physical dangers. With the lack of federal regulation in the marketplace, it is recommended that companies adopt these best practices to reduce the severity and likelihood of compromised food safety.

Automating processes and documenting critical control points within an ERP solution prevents hazards before food safety is compromised. Parameters determined within the ERP system are utilized for identification of potential hazards before further contamination can occur. Applying best practices historically used by food and beverage manufacturers provides an enhanced level of food safety protocols to ensure quality, consistency and safety of consumables.

Hazards of cannabis products by life-cycle and production stage

Since the identification of hazards is the first step in HACCP plan development, it is important to identify potential issues at each stage. For cannabis-infused products, these include cultivation, harvesting, extraction and edibles production. Auditors expect detailed documentation of HACCP steps taken to mitigate hazards through the entire seed-to-sale process, taking into account transactions of cannabis co-products and finished goods at any stage.

Cultivation– In this stage, pesticides, pest contamination and heavy metals are of concern and should be adequately addressed. Listeria, E. coli, Salmonella and other bacteria can also be introduced during the grow cycle requiring that pathogenic indicator testing be conducted to ensure a bacteria-free environment.

Harvesting– Yeast and mold (aflatoxins) are possible during the drying and curing processes. Due to the fact that a minimal amount of moisture is optimal for prevention, testing for water activity is essential during harvesting.

Extraction – Residual solvents such as butane and ethanol are hazards to be addressed during extraction, as they are byproducts of the process and can be harmful. Each state has different allowable limits and effective testing is a necessity to prevent consumer exposure to dangerous chemical residues.

Edibles– Hazards in cannabis-infused manufacturing are similar to other food and beverage products and should be treated as such. A risk assessment should be completed for every ingredient (i.e. flour, eggs, etc.), with inherent hazards or allergens identified and a plan for addressing approved supplier lists, obtaining quality ingredients, sanitary handling of materials and cross-contamination.

GMPFollowing and documenting the HACCP plan through all of the stages is essential, including a sampling testing plan that represents the beginning, middle and end of each cannabis infused product. As the last and most important step before products are introduced to the market, finished goods testing is conducted to ensure goods are safe for consumption. All information is recorded efficiently within a streamlined ERP solution that provides real-time data to stakeholders across the organization.

Besides hazards that are specific to each stage in the manufacturing of cannabis-infused products, there are recurring common procedures throughout the seed-to-sale process that can be addressed using current Good Manufacturing Practices (cGMP’s).  cGMPs provide preventative measures for clean work environments, training, establishing SOPs, detecting product deviations and maintaining reliable testing. Ensuring that employees are knowledgeable of potential hazards throughout the stages is essential.Lacking, inadequate or undocumented training in these areas are red flags for auditors who subscribe to the philosophy of “if it isn’t documented, it didn’t happen.” Training, re-training (if necessary) and documented information contained within cannabis ERP ensures that companies are audit-ready. 

Labeling

The importance of proper labeling in the cannabis space cannot be understated as it is a key issue related to product inconsistency in the marketplace. Similar to the food and beverage industry, accurate package labeling, including ingredient and allergen statements, should reflect the product’s contents. Adequate labeling to identify cannabis products and detailed dosing information is essential as unintentional ingestion is a reportable foodborne illness. Integrating an ERP solution with quality control checks and following best practices ensures product labeling remains compliant and transparent in the marketplace.

Due to the inherent hazards of cannabis-infused products, it’s necessary for savvy cannabis companies to employ the proper tools to keep their products and consumers safe. Utilizing an ERP solution that effectively manages HACCP plans meets auditing requirements and helps to keep cannabis operations one step ahead of the competition.

Product Release: PathogenDx Announces New Products, Branding

By Aaron G. Biros
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According to a press release published earlier this week, PathogenDx, Inc., is expanding their product portfolio and doing some rebranding. The DNA-based pathogen detection testing provider, headquartered in Scottsdale, Arizona, produces microarray testing platforms for the cannabis, agriculture and food and beverage industries. Their rapid testing technology can reportedly identify and detect 50+ pathogens all in a single test, including common pathogens such as E. Coli, Salmonella and Aspergillus.

Here is a look at their new product suite, taken from the press release:

  • DetectX – Tests for the presence of pathogenic microbial organisms down to a single organism, at less than 0.1 CFU/gram for state regulated compliance. Test 96 or more samples a day for multiple state mandated microbial pathogens, with product safety certainty delivered in 6 hours, far more rapid than current industry standards of 72 hours or more.

  • QuantX – The world’s first quantification microarray test for Cannabis. This test measures the microbial load in a sample, while also providing discrimination of the organism content relative to testing standards. Regulatory agencies will now have the opportunity to improve microbial testing standards to ensure safety.

  • EnviroX – With a single swab, one can identify 50+ species and classes of microbes, with quick-turn results, by simply swabbing a grower/cultivation facility surfaces and vents. Submit, identify, and remediate. It’s that simple to mitigate risk to high-value crops.

  • PhytoX – Coming in Summer of 2019, PathogenDx will introduce the ultra-rapid, easy plant pathogen test to detect powdery mildew, gray mold, mites and other microbial bugs that can become destructive threats to one’s crop. Acquire results in 6 hours to intercept and redress infestation that can destroy one’s yield.

According to CEO and Co-Founder Milan Patel, they want their technology to set the standard for product safety testing. “We’re making the accurate testing of cannabis, food and agriculture faster, more definitive and less expensive with trackable results benefitting growers, producers, regulators and consumers worldwide,” says Patel. “Our new brand is inspired by our unique microplex array and is bright, fresh, memorable and expansive, enabling us to move from cannabis only to much larger global consumable markets where we can continue to offer new products and applications for the technology.”

This announcement comes as the company is positioning itself to expand far beyond just the cannabis testing arena, diving into the food and beverage and agriculture industries with a much stronger presence. As recently as late February, the company announced purchases of new real estate, expanding their production capacity, as well as announcing a few key hires, expanding their leadership team. 

FSC logo

Food Safety Consortium To Address Cannabis Safety, Edibles Manufacturing

By Aaron G. Biros
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FSC logo

The 6thAnnual Food Safety Consortium Conference & Expo will feature an entire track dedicated to cannabis. As announced in May of this year, the Cannabis Quality series will feature presentations by subject matter experts in the areas of regulations, edibles manufacturing, cannabis safety & quality as well as laboratory testing.FSC logo

The Food Safety Consortium is hosted by our sister publication, Food Safety Tech, and the Cannabis Quality series will be co-hosted by Cannabis Industry Journal. A number of cannabis-focused organizations will participate in the series of talks, which are designed to help attendees better understand the cannabis edibles market, regulations surrounding the industry and standards for manufacturers. Some highlights include the following:

  • Ben Gelt, board chairman at the Cannabis Certification Council (CCC), will moderate a panel where leaders in the edibles market discuss supply chain, production and other difficulties in manufacturing infused products. Panelists include Leslie Siu, Founder/CEO Mother & Clone, Jenna Rice, Director of Operations at Gron and Kristen Hill, MIP Director, Native Roots Dispensary, among others. “The Cannabis Certification Council believes consumer education campaigns like #Whatsinmyweed are critical to drive standards and transparency like we see in food,” says Gelt. “What better place to discuss the food safety challenges the cannabis industry faces than the Food Safety Consortium”
  • Radojka Barycki, CEO of Nova Compliance, will discuss the role of food safety in the cannabis industry and identify some biological and chemical hazards in cannabis product testing in her talk, “Cannabis: A Compliance Revolution.”
  • Larry Mishkin, counsel to Hoban Law Group and partner at the law firm, Silver & Mishkin, which serves cannabis businesses in Illinois, will provide insights during the conference.
  • Cameron Prince, vice president of regulatory affairs at The Acheson Group, will help attendees better understand key market indicators and current trends in edibles manufacturing during his talk on November 15. “With the current trend of legalizing cannabis edibles, medicinal and recreational suppliers alike are looking to quickly enter the edibles market,” says Prince. “Understanding the nuances of moving to food production relative to food safety, along with navigating the food industry’s regulatory environment will be critical to the success of these companies.”
  • Tim Lombardo and Marielle Weintraub, both from Covance Food Solutions, will identify common pathogens and areas where cross contamination can occur for edibles manufacturers.

The Food Safety Consortium will be held November 13–15 in Schaumburg, Illinois (just outside of Chicago). To see the full list of presenters and register for the conference, go the Food Safety Consortium’s website.

Steven Burton

Top 4 Food Safety Hazards for the Cannabis Industry

By Steven Burton
18 Comments
Steven Burton

As many US States and Canadian provinces approach legalization of cannabis, the question of regulatory oversight has become a pressing issue. While public awareness is mainly focused on issues like age restrictions and impaired driving, there is another practical question to consider: should cannabis be treated as a drug or a food product when it comes to safety? In the US, FDA governs both food and drugs, but in Canada, drugs are regulated by Health Canada while food products are regulated under the CFIA.There are many food safety hazards associated with cannabis production and distribution that could put the public at risk, but are not yet adequately controlled

Of course, there are common issues like dosage and potency that pharmaceutical companies typically worry about as the industry is moving to classifying its products in terms of percentage of chemical composition (THC, CBD, etc. in a strain), much as we categorize alcohol products by the percentage of alcohol. However, with the exception of topical creams and ointments, many cannabis products are actually food products. Even the herb itself can be brewed into teas, added to baked goods or made into cannabis-infused butters, oils, capsules and tinctures.

FDAlogoAs more people gain access to and ingest cannabis products, it’s only a matter of time before food safety becomes a primary concern for producers and regulators. So when it comes to food safety, what do growers, manufacturers and distributors need to consider? The fact is, it’s not that different from other food products. There are many food safety hazards associated with cannabis production and distribution that could put the public at risk, but are not yet adequately controlled. Continue reading below for the top four safety hazards for the cannabis industry and learn how to receive free HACCP plans to help control these hazards.

Aflatoxins on Cannabis Bud

Just like any other agricultural product, improper growing conditions, handling and storage can result in mold growth, which produce aflatoxins that can cause liver cancer and other serious health problems. During storage, the danger is humidity; humidity must be monitored in storage rooms twice a day and the meter must be calibrated every month. During transportation, it is important to monitor and record temperatures in trucks. Trucks should also be cleaned weekly or as required. Products received at a cannabis facilities should be tested upon receiving and contaminated products must always be rejected, segregated and disposed of safely.

Petri dish containing the fungus Aspergillus flavus. It produces carcinogenic aflatoxins, which can contaminate certain foods and cause aspergillosis, an invasive fungal disease.
Photo courtesy of USDA ARS & Peggy Greb.

Chemical Residues on Cannabis Plants

Chemical residues can be introduced at several points during the production and storage process. During growing, every facility should follow instructions for applying fertilizers and pesticides to crops. This includes waiting for a sufficient amount of time before harvesting. When fertilizer is being applied, signs must be posted. After cannabis products have been harvested, chemical controls must be in place. All chemicals should be labelled and kept in contained chemical storage when not in use to prevent contamination. Only food-grade chemicals (e.g. cleaners, sanitizers) should be used during curing, drying, trimming and storage.

Without a comprehensive food safety program, problems will inevitably arise.There is also a risk of excessive concentration of chemicals in the washing tank. As such, chemical concentrations must be monitored for. In general, water (obviously essential for the growing process) also carries risks of pathogenic bacteria like staphylococcus aureus or salmonella. For this reason, city water (which is closely controlled in most municipalities) should be used with an annual report and review. Facilities that use well water must test frequently and water samples must be tested every three months regardless.

Pathogenic Contamination from Pest Infestations

Insects, rodents and other pests spread disease. In order to prevent infestations, a pest control program must be implemented, with traps checked monthly by a qualified contractor and verified by a designated employee. It is also necessary to have a building procedure (particularly during drying), which includes a monthly inspection, with no holes or gaps allowed. No product should leave the facility uncovered to prevent fecal matter and other hazards from coming into contact with the product. Contamination can also occur during storage on pallets, so pallets must be inspected for punctures in packaging material.

Furthermore, even the best controlled facility can fall victim to the shortcomings of their suppliers. Procedures must be in place to ensure that suppliers are complying with pest and building control procedures, among others. Certifications should be acquired and tracked upon renewal.

Pathogenic Contamination Due to Improper Employee Handling

Employee training is key for any food facility. When employees are handling products, the risk of cross-contamination is highest. Facilities must have GMP and personnel hygiene policies in place, with training conducted upon hiring and refreshed monthly. Employees must be encouraged to stay home when sick and instructed to wear proper attire (gloves, hair nets, etc.), while glass, jewelry and outside food must not be allowed inside the facility. Tools used during harvesting and other stages may also carry microorganisms if standard cleaning procedures are not in place and implemented correctly by employees.

As the cannabis industry grows, and regulatory bodies like the FDA and CFIA look to protect public safety, we expect that more attention will be paid to other food safety issues like packaging safety (of inks and labels), allergen control and others. In the production of extracts, for example, non-food safe solvents could be used or extracts can be mixed with ingredients that have expiration dates, like coconut oil. There is one area in which the cannabis industry may lead the way, however. More and more often, risks of food terrorism, fraud and intentional adulteration are gripping the food industry as the global food chain becomes increasingly complex. It’s safe to say that security at cannabis facilities is probably unparalleled.

All of this shows that cannabis products, especially edibles (and that includes capsules and tinctures), should be treated the same as other food products simply because they have the same kinds of hazards. Without a comprehensive food safety program (that includes a plan, procedures, training, monitoring and verification), problems will inevitably arise.