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Committee Blog: The Asset We Wish We Knew Before 2020 – HACCP

by Trevor Morones, Darwin Mallard, Liz Geisleman
NCIA’s Cannabis Manufacturing Committee

Read on for insight and guidance for the vitally important topic of preventing, eliminating, or reducing microbial growth in cannabis edibles and packaging. 

It all starts with the HACCP (Hazard Analysis Critical Control Point) Principles. Gather your team to share the five preliminary steps of HACCP and develop a plan (figure 1). This management system was launched by Pillsbury along with NASA and the U.S. Army for food safety in space exploration in the 1960’s. Quality, safety and efficacy is obtainable and sustainable with the HACCP discipline. 

The objective is to PREVENT packaging from being a failure point and inhibit microbial growth in edible products. We know moisture (water activity), temperature, pH, and oxygen levels are primary microbial growth drivers. 

HACCP is an asset, not an expense. Food is medicine for some, and cannabis products are medicine for many. Resin cannabis products (RCP) must be safe, consistent, and reliable products continuously. To generate those results, learn the HACCP mindset. Practice being an advocate with HACCP discipline displaying the actions written in the programs. It’s a system for cannabis safety that encourages operations to have Emergency and Business Continuity plans before disruptive events occur, e.g., natural disasters, pandemics, etc.

  • Resin cannabis product – Any product, whether finished or a work in progress, containing or comprised of cannabis flowers or resins or both and includes, but is not limited to, the cannabis flowers and resins themselves, extracts/concentrates/derivatives thereof, and preparations therefrom.
    • And can be further classified as Adult-Use or Medicinal-Use and subclassified as Topical-Use.

Creating such a plan is important because exposure to microbes may result in allergic symptoms such as sneezing, coughing, wheezing, nasal congestion, and watery or itchy eyes. Consumers using cannabis products as medicine, such as cancer patients on chemotherapy, are even more susceptible to harm caused by microbes. Thus, it is critical to ensure your products do not have microbial growth. 

This is not only a health concern, but the financial impacts can be detrimental. How much did the February 2021 Canadian infused gummy recall cost? More than 330,000 packages of THC infused gummies, worth approximately 8.2 million Canadian dollars, were lost. Overhead costs go above and beyond. The global cannabis industry must learn from industry events such as this.

Effective HACCP management system ensures control. Empower your team through education and training on discipline of HACCP. Take the infused gummy recall from February 2021 as an example where cross-contamination, improper employee hygiene, and package permeability were failure points that led to loss of control. Lack of control during transport of the initially sterile packaging also contributes to contamination. Personal clothing worn by team members or visitors are also known sources of pathogenic fungus. 

Best practice is to address preventive controls and reducing/mitigating risks. For example, consider installing two-way humidistatic control devices in packaging, such as desiccant packs, to maintain water activity (Aw) in acceptable ranges to mitigate microbial growth. Reducing moisture prevents powdery mildew caused by Golovinomyces Cichoracearum (figure 2). 

A great resource to mitigate risks can be found in the ASTM D37; Standard Guide for Cleaning and Disinfection at a Cannabis Cultivation Center; Aw ASTM Standards for Cannabis Flower: D8196 – Standard Practice for Determining Water Activity in Cannabis Flower; and D8197 – Standard Specification for Maintaining Acceptable Water Activity Range for Dry Cannabis Flower.

 Sanitary environments are critical from seed to sale.

Figure 2, Right. Powdery mildew development on leaves, stems, and flower buds of Cannabis sativa, caused by Golovinomyces cichoracearum. 2

Use the principles of HACCP to guide and maintain the integrity of your work. Each principle builds on the next to create a solid foundation to build and operate a safe and consistent management system. Establish storage conditions in your control and transport; determine the temperature and humidity for each product type (gummies do not tolerate heat, and certain ingredients are sensitive to humidity which could change the potency). This includes evaluating the stability of each of the ingredients when in final product form (how long do they remain potent). 

Depending on the ingredients used, i.e., the formulation, gummies can take on or reject water. Most typically let out the water, then that water has nowhere to go (trapped in the packaging), and the product molds. This is why commercially produced gummies are coated in wax, literally to trap the water inside the product. Inadequate gummy formulations lead to water permeability; change in cannabinoid content is the least of the concerns.

General chapter 659 on Packaging and Storage requirements published by the USP (United States Pharmacopeia and the National Formulary, USP–NF) is a great resource. Though not all cannabis products may be for the medical market, using the standards of excellence from the USP is the best way to minimize product failure and help ensure consumer safety. Packaging 659 states that packaging materials must not interact physically or chemically with a packaged article in a manner that causes its safety, identity, strength, quality, or purity to fail to conform to established requirements.

Empower your cross-functional team to apply and implement HACCP through your organization. In doing so, you will have the discipline and tools to mitigate risks and prevent costly downtime. Your consumers benefit by having safer, consistent, and quality products. Finally, collect the data and share the story. We all need to drive improvement and produce safe consistent products for our consumers. HACCP systems are a tried-and-true tool to achieve this.

Please note that prerequisite programs such as current Good Manufacturing Practices (cGMPs) are an essential foundation for the development and implementation of successful HACCP plans. This article is intended to level up your current manufacturing processes and mitigate your exposure to potential recall or unsafe products in the marketplace.

For resources on how to establish an effective HACCP system and other quality management related tools, consider adopting the best practices defined in ASTM D8250 – Standard Practice for Applying a Hazard Analysis Critical Control Points (HACCP) System for Cannabis Consumable Products and/or following the guidelines provided in ASTM D8222 – Standard Guide for Establishing a Quality Management System (QMS) for Consumer Use Cannabis/Hemp Products and ASTM D8229 Standard Guide for Corrective Action and Preventive Action (CAPA) for the Cannabis Industry.

 

Member Blog: Eradicating Pesticide Use in the Cannabis Industry – Without Sacrificing Crop Quality 

By Carlos Perea, Co-founder and CEO of Terra Vera

One of the direst, yet infrequently discussed, issues in the cannabis industry is the lack of federal guidelines regulating pesticide use. Despite the adult-use cannabis market consistently expanding on a state-by-state basis, as long as the crop remains illegal on the federal level, much-needed national oversight will continue to be limited. 

The more states that legalize under a national prohibition, the more varying and convoluted state-by-state crop management regulations may become. Meanwhile, without standards firmly set in stone across the country, some cultivators have turned to hazardous chemicals to control pathogens and preserve their crop yields. Such cultivation solutions can compromise the safety of staff, the environment and, of course, the consumers. 

Health Hazards of Pesticides in Cannabis

Even when shopping at a licensed adult-use or medical dispensary, consumers today still cannot be 100 percent confident that the cannabis they are purchasing is completely safe and free of contaminants and unwanted components, such as pesticides, harmful microbials, heavy metals, and solvents. Emerging research from Colorado State University shows that contaminants in cannabis, including pesticides, “are imminent threats that directly impact public health and wellness, particularly to the immunocompromised and pediatric patients who take cannabis products as a treatment for numerous human disorders including cancer patients and those suffering from epileptic seizures.” With many consumers turning to cannabis for its health benefits, and because it’s a natural alternative to heavily processed pharmaceuticals, the cultivation process should honor cannabis’ medical use by being as safe and accountable as possible.

The pesticide issue is compounded when we think about how cannabis is often consumed: through inhalation. Additional research has shown that nearly 70 percent of the pesticides used in cultivation remain in the cannabis flower that consumers smoke. 

Even when these same pesticides are permitted in other types of American agricultural industries, this is a global anomaly. More than 25 percent of pesticides used in the U.S. are banned in other countries.

Moving Towards a Pesticide-Free Flower  

So how do we work towards a pesticide-free cannabis industry? Licensed businesses, regulators, and consumers need to band together to set standards and guidelines for pesticide use across each legal state, and eventually on a federal level. 

In 2020, Arizona took a page out of Oregon’s playbook by establishing a regulatory agency and adopting Oregon’s standards for limiting pesticide use in cannabis, setting a prime example for inter-state collaboration and accountability. Measures also need to be taken to lower the cost of testing cannabis products for pesticides and contaminants. And, of course, we need to embrace more sustainability and environmentally-minded education, and emerging technologies.

While testing does not necessarily prevent contaminants during the grow process, frequent, reliable, and standardized testing can help ensure contaminated products don’t make it to market. Unfortunately, testing requirements continue to differ by state, with some being more lenient than others. For instance, certain states only test for certain types of microbials, while others allow companies and cultivators to cherry-pick samples. This makes it easier for companies’ products to meet compliance, however, doesn’t ensure that the final products available for purchase will be safe for the consumer. Looking ahead towards inevitable federal legalization, testing requirements need to be uniform across all legal markets.

However, cultivators shouldn’t wait for federal oversight to hold themselves to the highest possible standards. There are inexpensive testing procedures currently available that cultivators can adopt before sending their cannabis products to the lab, which can help to better ensure what they are doing is working and catch a problem before it starts. 

There are also non-toxic crop management technologies available now, and in addition to seeking out vendors offering innovation-driven solutions to replace conventional pesticides, cannabis companies and their cultivators can embrace simple, preventative measures to minimize outbreaks of bio-contaminants. This includes controlling humidity at the grow site, plant spacing, adequate air circulation, and implementing a strict chain of custody throughout the supply chain. Successful prevention mitigates the temptation to turn to potentially toxic pesticides to eradicate contaminants. 

While federal legalization looms, it likely won’t happen this year. Therefore, state regulatory agencies should continue to be prepared with comprehensive outreach plans to communicate their pesticide and testing regulations to cultivators and their companies, ensuring that industry participants are fully informed. Planning and communication also sets the stage for the industry to have tried and true standards already in place by the time federal legalization does come to fruition. 

The good news is the cannabis industry has the potential to lead a paradigm shift towards a safer agricultural sector as a whole. In years past, the amount of information shared between cannabis and other agricultural industries was limited, cutting cannabis cultivators off from reliable best practices for cultivation and crop management. However, this is changing quickly. Cannabis is also pushing the envelope towards more sustainable practices, with more cultivation sites moving indoors and into greenhouses, complete with LED lighting and additional sustainable practices. Cannabis cultivators are becoming more cutting-edge and setting an example for the broader agricultural community. The industry should continue these forward-thinking approaches by embracing pesticide-free solutions on a broad, scalable level.

Carlos Perea is the CEO and Co-founder of Terra Vera, an agricultural technology company offering innovative solutions to replace conventional pesticides and increase product safety and consumer confidence within the agriculture industry. Carlos is a serial entrepreneur with a focus on the intersection of technology and social impact. Prior to founding Terra Vera, he formed MIOX Corporation, a technology company that treats water in a variety of applications and is distributed in over 30 countries. He is active as an advisor and board member with several early stage companies and social enterprises including YPO, where is he an active board member. Carlos has an MBA from the Stanford Graduate School of Business, and an BS in Mechanical Engineering from the University of New Mexico.

 

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