The agenda features breakout sessions, keynotes and panel discussions that will help attendees better understand the cannabis markets in the region and provide insights on best practices and business strategies. The conference will begin with a keynote presentation, then a panel on The Future of East Coast Cannabis: Social Equity, Justice & Legalization. Following that will be a panel on The Standardization State of the Union: Science-Based Resources for Driving Cannabis Safety with an overview of the New Jersey cannabis marketplace to end the first day.
The second day will kick off with a Keynote titled Centering Equity in Cannabis Policy, Quality & Business with Toi Hutchinson, President & CEO at Marijuana Policy Project. Other agenda highlights include:
The State of the State: An Update on New Jersey Legalization by Steven M. Schain, Esquire, Attorney at Smart-Counsel, LLC
Tri-State Cannabis: Pro Tips for Winning Applications by Sumer Thomas, Director of Regulatory Affairs and Russ Hudson, Project Manager at Canna Advisors
Navigating Cannabis Testing Regulations for Multi-State Operations by Michael Kahn, President & Founder of MCR Labs
Keynote by Edmund DeVeaux, President of the New Jersey Cannabusiness Association
A Guide to Infusion Technology | Design Experiences that Inspire and Innovate with Cannabis Ingredients by Austin Stevenson, Chief Innovation Officer at Vertosa
Valuable Analysis Ahead of Asset Acquisition by Matthew Anderson, CEO of Vanguard Scientific
Registration options are available for in-person, virtual and hybrid attendance.
Cannabis industry professionals also interested in the food industry can attend the Food Safety Consortium, which begins on Wednesday, October 19 – Friday, October 21. The program features panel discussions and breakout sessions that encourage dialogue among mid-to-senior-level food safety professionals. The Food Safety Consortium kicks off with an FDA Keynote and Town Hall, followed by a panel on the State of the Food Safety Industry and where it is going, led by Darin Detwiler of Northeastern University.
About Cannabis Industry Journal
Cannabis Industry Journal is a digital media community for cannabis industry professionals. We inform, educate and connect cannabis growers, extractors, processors, infused products manufacturers, dispensaries, laboratories, suppliers, vendors and regulators with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an informed, legalized and safe cannabis marketplace.
About the Cannabis Quality Conference & Expo
The Cannabis Quality Conference & Expo is an educational and networking event for the cannabis industry that has cannabis safety, quality and regulatory compliance as the foundation of the educational content of the program. With a unique focus on science, technology, safety and compliance, the “CQC” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving cannabis industry.
Ted Harris, Founder & Executive Managing Director, Sweet Leaf Capital
This presentation delves into the craft cannabis market, genetics, going beyond potency, looking into cannabinoids and terpenes, quality vs. yield and much more.
Beyond Terpenes: What Else Is There and Why Should You Care?
Dr. Aldwin Anterola, Chief Science Officer, Veda Scientific
Leo Welder, CEO of Veda Scientific
Using GCxGC MS technology, we found that on average 40% of terpene content was not accounted for by the 40 standard terpenes used in cannabis testing labs. We have also detected other volatile compounds including alcohols, aldehydes, alkanes, aromatic and other hydrocarbons, esters, fatty acids, ketones and thiols. We will discuss the implications of this more comprehensive “volatilome” data including its significance in characterizing cannabis, distinguishing strains from each other, breeding for desired traits, improving quality and consistency of cannabis products, and even selecting better and safer processes and packaging
Hardy Diagnostics Sponsored TechTalk
Jessa Youngblood, Food and Beverage Market Coordinator, Hardy Diagnostics
Applying Integrated Pest Management to Cannabis Cultivation
Dan Banks, CCA, Co-Founder, Precision Crop Consulting, LLC
Attendees can expect to learn about: an introduction to IPM and how this approach to pest management applies to cannabis production, the components of an effective IPM program (Pest monitoring and identification, Structural & Environmental controls, Cultural practices, Resistant varieties, Biological controls, Compliant pesticide use) and actionable tips and suggestions relating to each component of a Cannabis IPM program.
Characterizing Nuisance Biofilms with NGS to Adopt Better Water Treatment Program
Taylor Robinson, Director of Analytical Services/R&D, Silver Bullet Corp.
Attendees can expect to learn about what biofilms are, how and why do they form, what is NGS and how can it be used in the context of biofilm analysis, and how can we use modern analytical techniques to implement more efficient treatment strategies.
What does Lean Mean to the World of Cannabis Testing?
Rob Radke, President, Method Testing Labs
In this session, Rob Radke delves into the world of Lean management, how Lean process implementation can enhance quality in a lab setting, what it means for customers and why it is unique and effective in the cannabis industry.
TechTalk: Hardy Diagnostics
Jessa Youngblood, Food & Beverage Market Coordinator II, Hardy Diagnostics
How Cannabis Labs Can Prepare for Accreditation?
Renee Delauter, Cannabis Program Manager, A2LA
Learn when to apply for your lab’s accreditation, what to expect during your ISO/IEC 17025 audit and find guidance on how to approach deficiency findings.
TechTalk: Bio-Rad
Helen Fong, Product Manager, Food Science Division, Bio-Rad
The Challenges and Benefits of National Standardization for Hemp Testing
Dillon Burns, Lab Manager, Infinite Chemical Analysis Labs
This presentation takes a deep dive into current hemp regulatory programs, why standardization is crucial and some shortcomings in current regulations.
Tracy Szerszen, President & Operations Manager, PJLA
Mohan Sabaratnam, Vice President, IAS
Kathy Nucifora, COO, COLA
Chris Gunning, General Manager for Accreditation Services, A2LA
Aaron Biros, Editor, CannabisIndustryJournal.com
In this session, the panel answers attendee questions related to ISO 17025:2017 accreditation for cannabis testing labs. Learn some of the common challenges labs face when seeking accreditation and learn about sampling protocols, security issues, statements of conformance, calibration and much more.
TechTalk: ANAB
Melanie Ross, Technical Products Developer, ANSI National Accreditation Board
R & D Lab Testing: Ensuring Success with Results
Mark Carter, president of MC Squared Enterprises
Learn how R&D lab testing can help you, prepare for compliance batches, successfully launch new products and amp up your quality control.
TechTalk: MilliporeSigma
USDA’s Hemp Testing Rules Have Changed: Accelerate Your Lab’s Preparedness
Arun Apte, CEO, CloudLIMS
This presentation takes a deep dive into understanding the requirements for USDA hemp testing, the operational changes hemp testing laboratories need to make to comply with the new hemp testing rules and the regulatory compliance framework and quality standards the testing labs need to meet.
Without clear direction from the FDA, states are filling the void by developing their own quality standards and testing requirements for hemp derived CBD products. Unlike their THC based counterparts, hemp derived CBD products are being sold across state lines raising the demand for a single testing panel that will be compliant in every state. Attendees will learn:
The current state of regulations nationally
The issues that hemp product manufacturers need to be educated on to ensure compliance,
The challenges labs face in offering customers a truly comprehensive panel.
Two decades ago, California became the first state to legalize the medical use of cannabis. In 2021, medical use of cannabis is legal is 36 US states, and 17 states allow adult (‘recreational’) use. This trend of rapid legalization of the cannabis industry, while encouraging for industry growth, attracts more attention from federal regulatory bodies such as the Occupational Safety and Health Administration (OSHA). Following a number of incidents and near misses, cannabis facilities have been increasingly frequented by OSHA visits, leading to a spike in citations and fines. A review of past OSHA citations reveals that the most common citations in the cannabis industry pertains to the employer’s lack of awareness about the hazardous nature of some operations and materials handled in the facility. This leads to an absence of a formal fire prevention plan, lack of proper hazardous chemical training, deficiency in proper documentation related to workplace injury and limited evaluation of required personal protective equipment (PPE).1
Cannabis industry data suggests that as of today, an incident is often followed by an OSHA inspection. This naturally leads to the facility asking, ‘How do we prepare for an OSHA inspection and prevent future citations?’ The answer is a combination of identifying and mitigating risks in advance to avoid incidents and developing management systems that support the identification and risk mitigation efforts. Recent collaboration between cannabis business owners and organizations that write codes and standards have provided a framework in which to address the industry’s unique safety challenges to help reduce inherent risk to a facility. These codes and standards typically impact building construction/safety features and operation of the facility, however, additional risk mitigation can be drawn from the best practices already in place in process industries with similar hazards. These process industries have embraced process safety management (PSM) programs, which are built around principles flexible enough to be successfully implemented in the cannabis industry. Adopting such programs will serve the dual purpose of improving the overall safety record of the cannabis industry while enhancing company sustainability2 and help avoid events that lead to OSHA citations.
Figure 1. Risk Based Process Safety Management System
The risk-based process safety (RBPS) approach developed by the Center for Chemical Process Safety (CCPS)3 may prove to be the most effective framework to implement PSM programs in the cannabis industry. Unlike the prescriptive regulatory approach provided by OSHA 29 CFR 1910.119, the RBPS methodology recognizes that not all hazards and risks are equal. By assessing risk, an organization can develop an effective management system that will prioritize allocation of limited resources to address the highest risks. Figure 1 shows the four foundational blocks (pillars) of RBPS and the various elements that make up each pillar.
If a cannabis business owner were to develop programs on each of the pillars presented in Figure 1, a comprehensive safety program would be in place that delivers sustainable risk reduction and mitigation. However, as with any industry, the elements can be prioritized and tackled over time, starting with the elements having the most influence on the overall safety of a given facility. For example, a given facility may have great procedures and practices, but may not consistently train or instill employee knowledge or competency. Conversely, a facility may have personnel with great knowledge of hazards and risks, but are less developed with regard to documenting procedures, safe practices or training for new hires. Focusing available resources on the less developed elements will lead to an overall improvement in facility risk, leading to a lower likelihood of an incident and OSHA inspection.
Figure 2. Still image from surveillance video of an explosion at New MexiCann Natural Medicine in July 2015.
As with any industry, positive and negative public perception is driven by the media, which tends to focus on attention-grabbing headlines. The majority of past incidents reported in the news for the cannabis industry were explosions that occurred during the extraction process. One such extraction explosion, shown in Figure 2, occurred in July 2015 at the New MexiCann Natural Medicine facility in Santa Fe, New Mexico. With a focus on the ‘hazard identification and risk analysis’ pillar of RBPS, future such events may be mitigated.
Of the twenty RBPS elements, hazard identification and risk analysis (HIRA) stands out as having the highest potential for immediate impact on the cannabis industry’s safety profile.
HIRA is a collection of activities carried out through the life cycle of a facility to ensure that the risks to employees and the public are constantly monitored to be within an organization’s risk tolerance. The four major areas to analyze are:
Hazards – What are the possible deviations from the design intent?
Consequences – What are the worst possible consequences (or severity) if any deviation occurs?
Safeguards – Are there safeguards in the system to reduce the likelihood of this event?
Risk – Is the risk within the tolerable level? If not, what steps are needed to reduce the risk? (Severity X Likelihood = Risk)
Figure 3. A simplified HIRA flow chart for an Extraction Process
Let us consider an example case where the extraction process utilizes propane or butane as the extracting solvent. Figure 3 shows a simplified HIRA flow chart for the extraction process.
This systematic approach helps to understand the hazards and evaluate the associated risk. In addition, this approach highlights operator training as a crucial safeguard that can be credited to lower the overall risk of the extraction facility. Remember, lack of proper safety training (another element!) is one of the most cited OSHA violations in the cannabis industry. Another advantage to the HIRA methodology is that other safeguards that may be present can be identified, their effectiveness evaluated and additional risk reduction measures may be recognized. This will help business owners allocate their limited resources on the critical safeguards that provide the greatest risk reduction. Identifying, analyzing and solving for potential hazards is a key step in safe operation of a facility and avoiding OSHA citations.
While this article discusses only a single RBPS element, this example demonstrates how best practices from process industries can become a powerful tool for use in the cannabis industry. The “hazard identification and risk analysis” element of the RBPS approach is pertinent not only for the extraction process as discussed above, but also directly applicable to other aspects of the industry (e.g., dust explosions in harvesting and processing facilities, toxic impacts from fertilizers, hazards from the CO2 enrichment process in growing facilities, etc.).
Three years ago, Canada became one of the first countries in the world to legalize and regulate cannabis. We’ve covered various aspects of cannabis regulation since, but now with a few years of data readily available, it’s time to step back and assess: what can we learn from three years of cannabis recalls in the world’s largest legal market?
Labelling Errors are the Leading Cause of Canadian Cannabis Recalls
Our analysis of Health Canada’s data revealed a clear leader: most cannabis recalls since legalization in October 2018 have been due to labelling and packaging errors. In fact, over three quarters of total cannabis recalls were issued for this reason, covering more than 140,000 units of recalled product.
The most common source of labelling and packaging recalls in the cannabis industry (more than half) is inaccurate cannabinoid information. Peace Naturals Project’s recall of Spinach Blue Dream dried cannabis pre-rolls this year is a good example. Not only did the packaging incorrectly read that the product contained CBD, but the THC quantity listed was lower than the actual amount of THC in the product. The recall covered over 13,000 units from a single lot sold over 10 weeks.
In another example, a minor error made a huge impact. British Columbia-based We Grow BC Ltd. experienced this firsthand when it misplaced the decimal points in its cannabinoid content. The recalled products displayed the total THC and CBD values as 20.50 mg/g and 0.06 mg/g, respectively, when the products contained 205.0 mg/g and 0.6 mg/g.
Accurate potency details are not just crucial for compliance. For many customers, potency is a deciding factor when selecting a cannabis product, and this is especially important for medicinal users (including children), people who are sensitive to certain cannabinoids and consumers looking for non-psychoactive effects. In this case, at least six consumer complaints were submitted to Peace Naturals Project, the highest number for any cannabis recall in Canada.
Pathogens are the #2 Cause of Cannabis Recalls in Canada
Pathogens are the second most common cause of recalls in Canada, claiming 18% of total cannabis recall incidents. And while that doesn’t sound like much compared to the recalls caused by labelling errors, it affects the highest volume of product recalled with over 360,000 units affected.
Canadian Cannabis Recalls – Total number of affected units and noted causes
A primary cause of allergens and microbiological contamination of cannabis products is yeast, mold and bacteria found on cannabis flower (chemical contaminants like pesticides can also be a major concern). Companies like Atlas Growers, Natural MedCo and Agro-Greens Natural Products have all learned this lesson through costly recalls.
These allergenic contaminants pose an obvious health risk, often leading to reactions such as wheezing, sneezing and itchy eyes. For people using cannabis for medical conditions and may be more susceptible to illness, pathogens can cause more serious health complications. Moreover, this type of cannabis recall not only drives significant cost since microbiological contamination of flower could easily affect several product batches processed in the same facility and/or trigger downstream recalls, but also affect consumer confidence for established cannabis brands.
Preventive control plan requirements for cannabis manufacturers mandate that holders of a license for processing that produce edible cannabis or cannabis extracts in Canada must identify and analyze the biological, chemical and physical hazards that present a risk of contamination to the cannabis or anything that would be used as an ingredient in the production of the edible cannabis or cannabis extract. Biological hazards can come from a number of sources, including:
Incoming ingredients, including raw materials
Cross-contamination in the processing or storage environment
Employees
Cannabis extract, edible cannabis and ingredient contact surfaces
Air
Water
Insects and rodents
To mitigate risks, addressing root causes with preventative measures and controls is essential. For instance, high humidity levels and honeydew secreted by insects are common causes of mold on cannabis flowers. Measures such as leaving a reasonable distance between plants, using climate-controlled areas to dry flowers, applying antifungal agents and conducting regular tests are necessary to combat such incidents.
Preventative measures and controls can save a business from extremely costly recalls.
Of course, placing all the necessary controls into action is not as simple as it may sound. Multiple facilities and a wide range of products in production mean more complexity for cannabis producers and processors. Any gaps in processing flower, extracts or edibles can result in an uncontrolled safety hazard that may lead to a costly cannabis recall.
These challenges are not just limited to cannabis growers. The food industry has been effectively mitigating the risk of biological hazards for decades with the help of food ERP solutions.
Avoid Recalls Altogether with Advanced ERP Technology
An effective preventative control plan with regular quality checks, internal audits and standardized testing is important to minimize the threats evident from Canada’s recall data. If these measures ever fail, real-time traceability systems play a pivotal role in the event of a cannabis recall by enabling manufacturers to trace back incidents to the exact point of contamination and identify affected products with surgical precision.
Instead of starting from zero, savvy cannabis industry leaders turn to the proven solutions from the food industry and take advantage of data-driven, automated systems that deliver the reliability and safety that the growing industry needs. From automated label generation to integrated lab testing to quality checks to precision traceability and advanced reporting, production and quality control systems are keys to success for the years ahead.
Botanical extraction is not specific to cannabis and hemp, and it is anything but new. Rudimentary forms of plant extraction have existed throughout history and evolved with high-tech equipment and scientific procedures for use in pharmaceuticals, dietary supplements and botanicals.
In food production, examples of hydrocarbon extraction processes are commonplace. Nut, olive and vegetable oil production use solvents to extract the oils. Decaffeinated coffee uses hydrocarbon extraction to remediate the caffeine, and making sugar from beets, or beer from hops, also requires solvents.
As such, the FDA has set guidelines for the amount of residual solvents considered safe for consumers to ingest. Yet, without FDA guidance in cannabis and hemp, many products aren’t being tested against these standards, and consumers will ultimately pay the price.
Understanding solvent remediation technology and processes
If we use ethanol extraction as an example, the extraction process is relatively simple. First, we soak the biomass in denatured or food-grade ethanol, ending up with a final solution that is 90-95% solvent. Then, we perform a bulk removal of the solvents, which takes out most, but not all, of the solvent. The next and final step should be to strip the remaining solvents from the extract entirely.
Stripping remaining solvents in bulk requires the right equipment.
But, in order to do so effectively, you need the right equipment, and unfortunately, this is where many producers fall short. Many producers use a vacuum oven to apply heat while reducing the headspace pressure to lower the solvent’s boiling point and evaporate it off.
However, it’s a static environment in a vacuum oven, which means the material is stagnant. So, the process may effectively remove the solvents close to the surface, but solvents deep inside the material tend to get trapped without some type of agitation or mixing.
The appropriate final step to complete solvent remediation is wipe-film distillation, which feeds small volumes into a column, which is then wiped into a very thin film and heated under vacuum pressure. Although the equipment necessary is costly, this last step removes any residual solvents from the product to create a safe, effective and consumable product.
Residual solvents present huge risks
As stated, many of the same solvents used in cannabis and hemp extraction have been considered safe in food production for decades. Reviewing chemical data sheets, many of the acceptable limits on solvents were determined for ingestion, which is fine for edibles and tinctures, but many cannabis and hemp products are intended for inhalation or vaporization.
Just a few of the dozens of various products types on the market today, extracted with a variety of different solvents
Unfortunately, some solvents can have negative health impacts, especially for those using cannabis or hemp for medical purposes or with compromised immune systems. Plus, as a therapeutic and recreational substance, consumers may be consuming more than the recommended amount, as well as using the products several times a day. Unfortunately, long-term exposure or repeated inhalation of these residual solvents hasn’t been thoroughly researched.
For example, inhaling ethyl alcohol (ethanol) can irritate the nose, throat and lungs. Extended exposure can cause headaches, drowsiness, nausea, vomiting and unconsciousness. Repeated exposure can affect the liver and nervous system.
In the food industry, hexane is approved for extracting spices or hops, and this solvent is widely used in cannabis and hemp extraction. However, if used in an inhalable product, chronic exposure to hexane could be detrimental, with symptoms including numbness in the extremities, weakness, vision problems and fatigue.
Consumers deserve transparency
In the industry’s earliest days, companies were tight-lipped about their processes, the chemicals they used and how they removed them. Everyone thought they had the “secret sauce” and didn’t want to share their approach. Today, companies are more open about what they use, how they process it and providing that necessary transparency.
Lack of quality and consistent regulations in these industries creates confusion for the consumers and loopholes for producers. Some producers test for everything under the sun, and some producers know exactly which labs will pass their products, regardless of test results.
While the regulatory bodies are distracted by the amount of THC that might linger in products, getting sick is overshadowed by the risk of getting high. In the meantime, consumers are left to their own devices to determine which products are safe and which are not.
Although testing mandates and regulations will help clean up the industry, until then, consumers need to demand full-panel COAs that not only show cannabinoid potency but also accurately display the test results for residual solvents, pesticides and heavy metals.
Facility layout and design are important components of overall operations, both in terms of maximizing the effectiveness and efficiency of the process(es) executed in a facility, and in meeting the needs of personnel. Prior to the purchase of an existing building or investing in new construction, the activities and processes that will be conducted in a facility must be mapped out and evaluated to determine the appropriate infrastructure and flow of processes and materials. In cannabis markets where vertical integration is the required business model, multiple product and process flows must be incorporated into the design and construction. Materials of construction and critical utilities are essential considerations if there is the desire to meet Good Manufacturing Practice (GMP) compliance or to process in an ISO certified cleanroom. Regardless of what type of facility is needed or desired, applicable local, federal and international regulations and standards must be reviewed to ensure proper design, construction and operation, as well as to guarantee safety of employees.
Materials of Construction
The materials of construction for interior work surfaces, walls, floors and ceilings should be fabricated of non-porous, smooth and corrosive resistant surfaces that are easily cleanable to prevent harboring of microorganisms and damage from chemical residues. Flooring should also provide wear resistance, stain and chemical resistance for high traffic applications. ISO 22196:2011, Measurement Of Antibacterial Activity On Plastics And Other Non-Porous Surfaces22 provides a method for evaluating the antibacterial activity of antibacterial-treated plastics, and other non-porous, surfaces of products (including intermediate products). Interior and exterior (including the roof) materials of construction should meet the requirements of ASTM E108 -11, Standard Test Methods for Fire Tests of Roof Covering7, UL 790, Standard for Standard Test Methods for Fire Tests of Roof Coverings 8, the International Building Code (IBC) 9, the National Fire Protection Association (NFPA) 11, Occupational Safety and Health Administration (OSHA) and other applicable building and safety standards, particularly when the use, storage, filling, and handling of hazardous materials occurs in the facility.
Utilities
Critical and non-critical utilities need to be considered in the initial planning phase of a facility build out. Critical utilities are the utilities that when used have the potential to impact product quality. These utilities include water systems, heating, ventilation and air conditioning (HVAC), compressed air and pure steam. Non-critical utilities may not present a direct risk to product quality, but are necessary to support the successful, compliant and safe operations of a facility. These utilities include electrical infrastructure, lighting, fire detection and suppression systems, gas detection and sewage.
Water
Microbial monitoring methods can include frequent/consistent testing
Water quality, both chemical and microbial, is a fundamental and often overlooked critical parameter in the design phase of cannabis operations. Water is used to irrigate plants, for personnel handwashing, potentially as a component in compounding/formulation of finished goods and for cleaning activities. The United States Pharmacopeia (USP) Chapter 1231, Water for Pharmaceutical Purposes 2, provides extensive guidance on the design, operation, and monitoring of water systems. Water quality should be tested and monitored to ensure compliance to microbiological and chemical specifications based on the chosen water type, the intended use of the water, and the environment in which the water is used. Microbial monitoring methods are described in USP Chapter 61, Testing: Microbial Enumeration Tests3and Chapter 62, Testing: Tests for Specified Microorganisms 4, and chemical monitoring methods are described in USP Chapter 643, Total Organic Carbon 5, and Chapter 645, Water Conductivity6.Overall water usage must be considered during the facility design phase. In addition to utilizing water for irrigation, cleaning, product processing, and personal hygiene, water is used for heating and cooling of the HVAC system, fogging in pest control procedures and in wastewater treatment procedures A facility’s water system must be capable of managing the amount of water required for the entire operation. Water usage and drainage must meet environmental protection standards. State and local municipalities may have water usage limits, capture and reuse requirements and regulations regarding runoff and erosion control that must also be considered as part of the water system design.
Lighting
Lighting considerations for a cultivation facility are a balance between energy efficiency and what is optimal for plant growth. The preferred lighting choice has typically been High Intensity Discharge (HID) lighting, which includes metal halide (MH) and high-pressure sodium (HPS) bulbs. However, as of late, light-emitting diodes (LED) systems are gaining popularity due to increased energy saving possibilities and innovative technologies. Adequate lighting is critical for ensuring employees can effectively and safely perform their job functions. Many tasks performed on the production floor or in the laboratory require great attention to detail. Therefore, proper lighting is a significant consideration when designing a facility.
HVAC
Proper lighting is a significant consideration when designing a facility.
Environmental factors, such as temperature, relative humidity (RH), airflow and air quality play a significant role in maintaining and controlling cannabis operations. A facility’s HVAC system has a direct impact on cultivation and manufacturing environments, and HVAC performance may make or break the success of an operation. Sensible heat ratios (SHRs) may be impacted by lighting usage and RH levels may be impacted by the water usage/irrigation schedule in a cultivation facility. Dehumidification considerations as described in the National Cannabis Industry Association (NCIA) Committee Blog: An Introduction to HVACD for Indoor Plant Environments – Why We Should Include a “D” for Dehumidification 26 are critical to support plant growth and vitality, minimize microbial proliferation in the work environment and to sustain product shelf-life/stability. All of these factors must be evaluated when commissioning an HVAC system. HVAC systems with monitoring sensors (temperature, RH and pressure) should be considered. Proper placement of sensors allows for real-time monitoring and a proactive approach to addressing excursions that could negatively impact the work environment.
Compressed Air
Compressed air is another, often overlooked, critical component in cannabis operations. Compressed air may be used for a number of applications, including blowing off and drying work surfaces and bottles/containers prior to filling operations, and providing air for pneumatically controlled valves and cylinders. Common contaminants in compressed air are nonviable particles, water, oil, and viable microorganisms. Contaminants should be controlled with the use appropriate in-line filtration. Compressed air application that could impact final product quality and safety requires routine monitoring and testing. ISO 8573:2010, Compressed Air Specifications 21, separates air quality levels into classes to help differentiate air requirements based on facility type.
Electrical Infrastructure
Facilities should be designed to meet the electrical demands of equipment operation, lighting, and accurate functionality of HVAC systems. Processes and procedures should be designed according to the requirements outlined in the National Electrical Code (NEC) 12, Institute of Electrical and Electronics Engineers (IEEE) 13, National Electrical Safety Code (NESC) 14, International Building Code (IBC) 9, International Energy Conservation Code (IECC) 15 and any other relevant standards dictated by the Authority Having Jurisdiction (AHJ).
Fire Detection and Suppression
“Facilities should be designed so that they can be easily expanded or adjusted to meet changing production and market needs.”Proper fire detection and suppression systems should be installed and maintained per the guidelines of the National Fire Protection Association (NFPA) 11, International Building Code (IBC) 9, International Fire Code (IFC) 10, and any other relevant standards dictated by the Authority Having Jurisdiction (AHJ). Facilities should provide standard symbols to communicate fire safety, emergency and associated hazards information as defined in NFPA 170, Standard for Fire Safety and Emergency Symbols27.
Gas detection
Processes that utilize flammable gasses and solvents should have a continuous gas detection system as required per the IBC, Chapter 39, Section 3905 9. The gas detection should not be greater than 25 percent of the lower explosive limit/lower flammability limit (LEL/LFL) of the materials. Gas detection systems should be listed and labeled in accordance with UL 864, Standard for Control Units and Accessories for Fire Alarm Systems16 and/or UL 2017, Standard for General-Purpose Signaling Devices and Systems 17 and UL 2075, Standard for Gas and Vapor Detectors and Sensors18.
Product and Process Flow
Product and process flow considerations include flow of materials as well as personnel. The classic product and process flow of a facility is unidirectional where raw materials enter on one end and finished goods exit at the other. This design minimizes the risk of commingling unapproved and approved raw materials, components and finished goods. Facility space utilization is optimized by providing a more streamlined, efficient and effective process from batch production to final product release with minimal risk of errors. Additionally, efficient flow reduces safety risks to employees and an overall financial risk to the organization as a result of costly injuries. A continuous flow of raw materials and components ensures that supplies are available when needed and they are assessable with no obstructions that could present a potential safety hazard to employees. Proper training and education of personnel on general safety principles, defined work practices, equipment and controls can help reduce workplace accidents involving the moving, handling, and storing of materials.
Facilities Management
Facilities management includes the processes and procedures required for the overall maintenance and security of a cannabis operation. Facilities management considerations during the design phase include pest control, preventative maintenance of critical utilities, and security.
Damage from whiteflies, thrips and powdery mildew could be prevented with an appropriate PCP
A Pest Control Program (PCP) ensures that pest and vermin control is carried out to eliminate health risks from pests and vermin, and to maintain the standards of hygiene necessary for the operation. Shipping and receiving areas are common entryways for pests. The type of dock and dock lever used could be a welcome mat or a blockade for rodents, birds, insects, and other vermin. Standard Operating Procedures (SOPs) should define the procedure and responsibility for PCP planning, implementation and monitoring.
Routine preventative maintenance (PM) on critical utilities should be conducted to maintain optimal performance and prevent microbial and/or particulate ingress into the work environment. Scheduled PMs may include filter replacement, leak and velocity testing, cleaning and sanitization, adjustment of airflow, the inspection of the air intake, fans, bearings and belts and the calibration of monitoring sensors.
In most medical cannabis markets, an established Security Program is a requirement as part of the licensing process. ASTM International standards: D8205 Guide for Video Surveillance System 23, D8217 Guide for Access Control System[24], and D8218 Guide for Intrusion Detection System (IDS) 25 provide guidance on how to set up a suitable facility security system and program. Facilities should be equipped with security cameras. The number and location of the security cameras should be based on the size, design and layout of the facility. Additional cameras may be required for larger facilities to ensure all “blind spots” are addressed. The facility security system should be monitored by an alarm system with 24/7 tracking. Retention of surveillance data should be defined in an SOP per the AHJ. Motion detectors, if utilized, should be linked to the alarm system, automatic lighting, and automatic notification reporting. The roof area should be monitored by motion sensors to prevent cut-and-drop intrusion. Daily and annual checks should be conducted on the alarm system to ensure proper operation. Physical barriers such as fencing, locked gates, secure doors, window protection, automatic access systems should be used to prevent unauthorized access to the facility. Security barriers must comply with local security, fire safety and zoning regulations. High security locks should be installed on all doors and gates. Facility access should be controlled via Radio Frequency Identification (RFID) access cards, biometric entry systems, keys, locks or codes. All areas where cannabis raw material or cannabis-derived products are processed or stored should be controlled, locked and access restricted to authorized personnel. These areas should be properly designated “Restricted Area – Authorized Personnel Only”.
Future Expansion
The thought of expansion in the beginning stages of facility design is probably the last thing on the mind of the business owner(s) as they are trying to get the operation up and running, but it is likely the first thing on the mind of investors, if they happen to be involved in the business venture. Facilities should be designed so that they can be easily expanded or adjusted to meet changing production and market needs. Thought must be given to how critical systems and product and process flows may be impacted if future expansion is anticipated. The goal should be to minimize down time while maximizing space and production output. Therefore, proper up-front planning regarding future growth is imperative for the operation to be successful and maintain productivity while navigating through those changes.
References:
United States Environmental Protection Agency (EPA) Safe Drinking Water Act (SDWA).
United States Pharmacopeia (USP) Chapter <1231>, Water for Pharmaceutical Purposes.
United States Pharmacopeia (USP) Chapter <61>, Testing: Microbial Enumeration Tests.
United States Pharmacopeia (USP) Chapter <62>, Testing: Tests for Specified Microorganisms.
United States Pharmacopeia (USP) Chapter <643>, Total Organic Carbon.
United States Pharmacopeia (USP) Chapter <645>, Water Conductivity.
ASTM E108 -11, Standard Test Methods for Fire Tests of Roof Coverings.
UL 790, Standard for Standard Test Methods for Fire Tests of Roof Coverings.
International Building Code (IBC).
International Fire Code (IFC).
National Fire Protection Association (NFPA).
National Electrical Code (NEC).
Institute of Electrical and Electronics Engineers (IEEE).
National Electrical Safety Code (NESC).
International Energy Conservation Code (IECC).
UL 864, Standard for Control Units and Accessories for Fire Alarm Systems.
UL 2017, Standard for General-Purpose Signaling Devices and Systems.
UL 2075, Standard for Gas and Vapor Detectors and Sensors.
International Society for Pharmaceutical Engineers (ISPE) Good Practice Guide.
International Society for Pharmaceutical Engineers (ISPE) Guide Water and Steam Systems.
ISO 8573:2010, Compressed Air Specifications.
ISO 22196:2011, Measurement Of Antibacterial Activity On Plastics And Other Non-Porous Surfaces.
D8205 Guide for Video Surveillance System.
D8217 Guide for Access Control Syst
D8218 Guide for Intrusion Detection System (IDS).
National Cannabis Industry Association (NCIA): Committee Blog: An Introduction to HVACD for Indoor Plant Environments – Why We Should Include a “D” for Dehumidification.
NFPA 170, Standard for Fire Safety and Emergency Symbols.
Hemp & Delta-8 in the United States: The Evolution of the Hemp Testing Market
Charles Deibel, President & CEO, Deibel Labs, Inc.
In this session, Charles Deibel discusses the current state of affairs across the country with respect to hemp testing. This includes a look at hemp testing rules at the state and federal level. He also provides an in-depth analysis on delta-8 THC and the controversy surrounding this cannabinoid, how to analyze samples of it and why the market has exploded around this product.
Kathleen May, Founder & Owner, Triskele Quality Solutions
This presentation discusses where the standard falls short, how poor lab practices may negatively impact the consumer and how poor or insufficient lab practices could result in regulatory action, including product recalls, fines, and loss of licenses.
TechTalk: ANAB
Melanie Ross, Technical Products Developer, ANSI National Accreditation Board (ANAB)
TechTalk: Columbia Labs
Kelly O’Connor, Sales Director Key Accounts, Columbia Labs
Pesticides in Hemp: Challenges and Solutions
Grace Bandong, Business Unit Manger for Contaminants, Eurofins Food Chemistry Testing (EFCT)
This presentation takes a deep dive into understanding the requirements for pesticide testing, approaches to analysis and responding to regulatory requirements with extremely low LOQs.
TechTalk: Perkin Elmer
Tim Cooper, Sr. Manager, Software Development, PerkinElmer
This presentation provides an overview of how standards are developed and used, how Official Methods for cannabis are developed as well as training opportunities and proficiency testing.
What to Expect When Opening a Lab in a New State
Michael Kahn, Founder & CEO, MCR Labs
Kahn explores the lab’s role int he cannabis industry, the importance of knowing and understand state regulations and lessons for growing your lab while maintaining quality.
Earlier this year, the Colorado Department of Public Health and Environment (CDPHE) announced a plan to introduce new testing rules for the state’s growing hemp industry. Under the new regulations, hemp products must be tested for residual solvents, heavy metals and pesticides, in addition to making sure they contain less than 0.3% THC.
The CDPHE are planning on a gradual rollout to prevent any supply chain issues or a lab testing bottleneck, similar to what we’ve seen in other states launching new testing requirements in years past, such as Arizona or California. Well, the Colorado rollout appears to be hitting similar snags and because of supply chain issues related to instruments and consumables in laboratories, the implementation of those testing rules is somewhat delayed. What was originally supposed to be implemented over the summer was pushed back to an October 1 deadline, and that deadline has now been pushed back to 2022.
The pesticide testing list to be implemented January 1, 2022
As a result of supply chain shortages and the learning curve to test for such a wide range of pesticides, Colorado is opening hemp testing to out-of-state labs in an effort to stay on schedule with the rollout. Dillon Burns, lab manager at InfiniteCAL, a cannabis testing company with locations in California and Michigan, just completed an audit with the CDPHE in their work to get certified and start conducting hemp testing for businesses in Colorado.
Burns says they’re well-acquainted with the list of pesticides because of how similar the list is to California’s requirements. “For the pesticide testing rules that were supposed to go into effect on August 1st, it’s basically the same list as California just with slightly different action levels,” says Burns. “I would say these action limits are generally stricter – they have much lower LOQs [limits of quantification].”
The pesticide testing list (continued) to be implemented January 1, 2022
Come January 1, 2022, they are expecting an additional 40 pesticides to be required under the new rules. “But currently, it’s still unclear when these regulations will actually go into effect,” says Burns. The full pesticide testing list is currently slated to be implemented on April 1, 2022.
The supply chain issues referenced above have a lot to do with what the state is asking labs to test for. Previously, most of the pesticides tested for under Colorado’s adult use and medical cannabis programs could be analyzed with an LC/MS. A handful of pesticides on the new list do require GC/MS, says Burns. It’s entirely possible that a lot of labs in Colorado just don’t have a GC/MS or are in the process of training staff and developing methods for using the new instrument. “Cleanliness of these instruments is such a priority that it takes time to acquire the right skill set for it,” says Burns.
Dillon Burns, Lab Manager at InfiniteCAL
The new testing rollout isn’t just another compliance hurdle for the cannabis industry; these rules are about protecting public health. Dillon Burns said he’s seen hiccups in California with the amount of new hemp farmers getting into the space. “The hemp products we’ve tested in California often fail for pesticides,” says Burns. It’s a lot easier in most states to get a license for growing hemp than it would be for growing adult use cannabis. “You’ll see a lot more novice growers getting into hemp farming without a background in it. They’ll fail for things they just haven’t considered, like environmental drift. We see a lot of fails in CA. Hemp is bioaccumulating so it presents a lot of problems. If they’re not required to look for it, they weren’t monitoring it.”
When asked how the market might react to the new rules, Burns was confident that Colorado knows what they’re doing. “I don’t anticipate that [a testing bottleneck] happening here. The regulators are reasonable, supportive of the industry and opening it up to out-of-state labs should help in preventing that.”
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The agenda features breakout sessions, keynotes and panel discussions that will help attendees better understand the cannabis markets in the region and provide insights on best practices and business strategies. The conference will begin with a keynote presentation, then a panel on The Future of East Coast Cannabis: Social Equity, Justice & Legalization. Following that will be a panel on The Standardization State of the Union: Science-Based Resources for Driving Cannabis Safety with an overview of the New Jersey cannabis marketplace to end the first day.
Cannabis Industry Journal is a digital media community for cannabis industry professionals. We inform, educate and connect cannabis growers, extractors, processors, infused products manufacturers, dispensaries, laboratories, suppliers, vendors and regulators with original, in-depth features and reports, curated industry news and user-contributed content, and live and virtual events that offer knowledge, perspectives, strategies and resources to facilitate an informed, legalized and safe cannabis marketplace.
The Cannabis Quality Conference & Expo is an educational and networking event for the cannabis industry that has cannabis safety, quality and regulatory compliance as the foundation of the educational content of the program. With a unique focus on science, technology, safety and compliance, the “CQC” enables attendees to engage in conversations that are critical for advancing careers and organizations alike. Delegates visit with exhibitors to learn about cutting-edge solutions, explore three high-level educational tracks for learning valuable industry trends, and network with industry executives to find solutions to improve quality, efficiency and cost effectiveness in the evolving cannabis industry.
