Doctors are still very hesitant to recommend cannabis in medical treatment of their patients. A key aspect missing from the medical cannabis industry is participation from physicians and the medical community. Cannabis’ Schedule I drug status blocks medical research and leaves a stigma in the medical community. Doctors are concerned with the implications of recommending cannabis, the possibility of losing their license to practice and most lack any formal education in prescribing cannabis. The DEA’s recent announcement to consider rescheduling cannabis this year could dramatically impact doctor’s willingness to work with the drug.
The DEA’s plan to release a decision on the matter represents a major shift in attitude toward treating patients with medical cannabis. This could very possibly culminate in the rescheduling of cannabis, which would allow for more medical research, including clinical trials. Dr. Scott Gottlieb, board-certified anesthesiologist and pain management specialist from Pearl River, New York, believes the bigger obstacles for doctors prescribing cannabis include the stigma associated with it, legal concerns and physicians’ lack of education. Dr. Gottlieb has practices in both New York and New Jersey where he recommends patients cannabis. He believes there should be some type of recourse to help physicians circumvent legal issues. “Some of the bigger legal concerns regarding cannabis surround complying with state regulations,” says Gottlieb. “That sort of compliance includes confirming the diagnosis of the patient with thorough documentation, making sure it is an approved condition to treat with cannabis, documenting continued treatment of the illness and clearing the patient of any contraindications.”
Dr. Gottlieb believes it should be a collaborative effort on behalf of states, dispensaries and patients working to help educate doctors on the legal concerns surrounding the recommendation of cannabis. “Physicians are not taught anything in medical school about dosing or the medical effects of cannabis,” says Gottlieb. “With more education we can get rid of the stigma and get physicians aware of the potential benefits for their patients and the ability to control dosage in medication.”
Currently, there is very little communication between doctors and dispensaries in New York. A collaborative effort to educate all stakeholders involved could help get more doctors involved and streamline the entire process. “Doctors want patients to feel comfortable and know what to expect in receiving treatment with cannabis,” continues Gottlieb. “Which will come with a more transparent system, involving patients, doctors and dispensaries in a conversation about education.”
Pointing to the success of doctors actively recommending cannabis could also facilitate doctor participation. “The number one reason why I recommend cannabis is that I have a number of patients that use it to successfully treat their conditions and completely eliminate their opioid regiment,” says Gottlieb. That kind of success in a treatment should grab the attention of physicians as what could possibly be best for their patients. With more education and research, doctors will gradually feel more comfortable recommending cannabis to their patients.
In a letter sent to lawmakers last week, the Drug Enforcement Agency (DEA) announced plans to make a decision on rescheduling cannabis by mid-2016. The announcement could represent the culmination of a shift in the federal government’s attitude toward cannabis legalization.
Currently, cannabis is a Schedule I narcotic, meaning the government views it as lacking medical benefits and have a high potential for abuse. The rescheduling of cannabis has the potential to open the floodgates for research, including much needed clinical trials.
Derek Peterson, chief executive officer at Terra Tech, a cannabis-focused agriculture company, believes this bodes well for the growth potential of the cannabis industry. “From the perspective of quality and safety standards, I find it unlikely that rescheduling it would negatively impact the degree to which cannabis is examined,” says Peterson. “It’s unnecessarily high position on the DEA drug schedule does nothing but limit the industry’s potential for growth, stall any meaningful pharmaceutical testing and increase law enforcement’s ability to prosecute non-violent drug offenders,” adds Peterson.
The rescheduling could also potentially allow for the prescribing of cannabis for patients. Stephen Goldner, founder of Pinnacle Labs and president of Regulatory Affairs Associates, is hopeful this will lead to a greater shift in public attitude towards cannabis. “The DEA’s announcement is a clear message to all States and possibly even to United Nations policy makers: even the DEA is willing to reconsider cannabis,” says Goldner. “Since the DEA is reconsidering cannabis, state politicians and local police departments can also be flexible and move away from prohibition, towards the regulation of cannabis.”
The rescheduling of cannabis could have a tremendous impact on the growth of the cannabis industry, including more clinical trials, medical research and physician participation. It could also open the door for more federal agency involvement, as the Schedule I status inhibits any EPA research on cannabis pesticide use or FDA guidance on food and drug good manufacturing practices. When reached for comment, the FDA’s press office said they could not speculate on any involvement in the matter.
DNA stores information about how to build an organism. Just as a series of 0’s and 1’s represents digital data, DNA data is represented by four letters (A, C, G and T), which inherently allows DNA to store more information per unit (Figure 1).
Figure 1
The amount of DNA required to build a human is mind-boggling. The human genome has 3.2 billion A’s, C’s, G’s, or T’s, (called nucleotides). Cannabis has 820 million nucleotides. This is true for every cell in the organism. The DNA from a single human cell when spread out would stretch six feet long. A cell is not visible to the naked eye, yet it contains a microscopic thread of DNA six feet long! If you put all the DNA molecules in your body end to end, the DNA would reach from the Earth to the Sun.
DNA is common in all living things, and all living things are related through DNA. Humans and plants share 50% of their genes. In humans, 99.9% of the DNA is identical, thus just 0.1% of DNA differences accounts for all of the variation observed in humans. Cannabis, as a species, is more variable with approximately 1% of the DNA being different among strains. DNA is a super efficient and reliable information storage system. However, mistakes (mutations) do occur and while infrequent, these mutations account for all the differences observed within a species and is called natural genetic variation. Variation within the genomes of a species can help the species survive in unfavorable conditions (evolution) and is also the source of differences in traits, which is the material that is required for successful breeding.
Natural Genetic Variation
DNA mutations occur in every generation and these changes will be different in each individual creating natural genetic variation. Mutations (or more accurately referred to as DNA changes) will be inherited by offspring and will persist in the population if the offspring reproduce.
Figure 2
DNA differences maintain diversity in the gene pool, allowing organisms to respond to new environments (migration) or environmental changes (adaptation). The two most commonly described cannabis families are Indicas and Sativas. Indicas, being from cooler temperate regions, have wide leaves allowing the maximum capture of light during the shorter growing season. Sativas, being equatorial, have smaller leaves, which may be an advantage for such things as powdery mildew in a humid environment. Figure 2 shows the enormous amount of natural variation in leaves for one species with a worldwide population (Arabidopsis thaliana).
A DNA change that occurred a long time ago will be more useful to divide people/plants into different groups. For example, there are ancient DNA changes that differentiate humans originating from Europe or Asia. Other newer DNA changes allow us to further divide Europeans into those originating from Northern versus Southern Europe. Thus, different DNA changes have different values for determining relatedness or ancestry, yet every DNA change provides some information for determining heredity.
Figure 3
Family Trees
By comparing DNA changes among different strains, we can measure the relatedness between strains. For example, if strain A has a DNA change indicative of Kush ancestry and strain B has a DNA change indicative of hemp ancestry, we can assign strains to branches of the cannabis family tree comprised of strains that contain similar DNA changes. Figure 3 shows 184 strains that have been characterized for these changes, and the position of each strain is based on its shared DNA with neighboring strains. The two best-defined families of cannabis are hemp (blue) and kush (black). Strains within a family are more closely related. Strains in separate families, such as kush and hemp, are more distantly related.
Editor’s Note: This is the first installment in a series of articles focused on answering common questions regarding cannabis genetics. If you have questions regarding cannabis genetics, or wish to speak more about the topic please post in the comments section below. The next installment will delve into the THC synthase, gene discovery and manipulation and mapping chromosomes.
The Colorado Department of Public Health and Environment (CDPHE) launched the Good to Know program in January of 2015, aimed at educating the public on consuming cannabis responsibly. The CDPHE developed a free kit for retailers that will be distributed this week, hoping to reinforce safe and responsible experiences with cannabis at the consumer level. Intended specifically for recreational cannabis retailers, the educational materials will be distributed at the point of sale.
The Good to Know kit for retailers
According to the CDPHE, last year between April and August, Colorado saw a 28 percent increase in retail cannabis sales. In anticipation of a period of high demand this summer, the ‘Good to Know’ retailer kits are being distributed this week. According to Ali Maffey, CDPHE policy and communication unit supervisor, the state is mailing 100 kits to additional retailers ahead of cannabis-related events, such as April 20th, which are expected to bring an influx of tourists.
The takeaway information cards in the kits display frequently asked questions regarding edibles and secondhand smoke, as well as advice for appropriate legal usage of cannabis. “The educational materials can help guide bud tenders through a conversation with a consumer to prepare them for the effects of cannabis, dosage considerations, using caution with edibles, driving impairment and the risks of second hand smoke,” says Maffey. “Voters passed the legalization of cannabis, and as the state health department our role is to educate on the safe and responsible use of cannabis, while safeguarding public health.”
The continued efforts by the state for consumer education could highlight an important push for safety. “We have been talking with other states about what works in our messaging and they are all looking at public education campaigns as well,” says Maffey. In this respect, Colorado is leading the country in educating consumers on safe, responsible and legal cannabis use.
Would you be proud to have your customers and patients tour your production facility? When health inspectors or enforcement personnel arrive at your location is there sense of panic or pride?
When you have detailed systems in place, inspections should be informative, not stressful. Keep in mind that in the cannabis industry, products are often created for patients. Patients may have a compromised immune system and thus are more susceptible to food borne illnesses, pesticides and other contaminants.
Are you and your team doing everything you can to produce a wholesome and safe product?
According to the World Health Organization, Good Manufacturing Process (GMP) “is a system for ensuring that products are consistently produced according to quality standards.”
GMP is the proactive part of quality assurance. It is designed to minimize the risks involved in all steps of the manufacturing process. A basic tenant of GMP is that quality cannot be tested into a product. It must be built into each batch of product during all stages of the manufacturing process.
GMPs involve much more than most people think. A common misconception is that GMP only covers the process of manufacturing itself. GMPs actually cover all aspects of the production process:
Materials
Premises
Equipment
Storage
Record Keeping
Staff Training to Hygiene
How Complaints Are Handled
GMP & The Cannabis Industry
In most industries, agencies that control licensing for the manufacture and sale of a product recommend GMPs, or guidelines to business owners. These guidelines provide minimum requirements that a manufacturer must meet to assure that products are of high quality and do not pose any risk to the consumer or public. The guidelines generally become the basis of regulation for that industry.
In the United States, the Food and Drug Administration (FDA) recommends guidelines for anything food, drug or pharmaceutical related.
Because cannabis still remains illegal at the federal level, none of the federal agencies that would normally develop good manufacturing guidelines have done so. This has left state lawmakers and business owners on their own to navigate this new and rapidly developing industry.
The Foundation of Cannabis Unified Standards (FOCUS) has developed standards with a mission to protect public health, consumer safety and safeguard the environment by promoting integrity in the cannabis industry.
The comprehensive implementation of cannabis specific good manufacturing practices, like the FOCUS standards, across all aspects of the industry will assist business owners and regulators alike, addressing quality proactively at every step in the process, which is critical to protecting consumer safety and public health – and the overall success of a nascent and divisive industry like cannabis.
The FOCUS standards are completing the final phase of development, a thirty-day public review and comment period before being released for use in the marketplace in June. These voluntary consensus-based standards are built on GMPs drawn from agriculture, food production, chemical management, OTCs, pharmaceuticals, and other relevant industries. In addition, the standards draw best practices from the cannabis industry, as well as those published in OSHA, FDA, FTC, CDC, ISO, code of federal regulations and various state-level cannabis regulations.
There are many aspects of creating and implementing GMPs. Here are three to be aware of:
Get the facility design right from the start: It’s much easier to be GMP compliant if the design and construction of the facilities and equipment are right from the start. It is important to embody GMP principles and use GMPs to drive every decision.
Document what you do and do what you document: Having good procedures in place to ensure a controlled and consistent performance is an essential part of GMP. Procedures should be clear, concise, logical, and available to everyone.
Keep good records: Keeping accurate records is an essential part of GMP. It helps convey that you are following procedures and demonstrates that processes are known and under control. If it’s not written down, it did not happen.
Standards and quality programs in any industry are dynamic by nature. Nothing is static. Standards must constantly be updated to reflect ever-changing market conditions. This is why it is so crucial that regulations are based on them.
To be a standard, there are certain core principals that must be present. However, the goal of a standard is to guide an industry without impeding or controlling it. This is why there is so much inherent value in implementing standards. They bring enough structure to help reduce costs and increase efficiency, but not so much control that individual nuances or creativity is affected.
It is much less expensive to be proactive. Recovering from a recall or contaminated product can not only be costly, it is a massive hit to the company’s reputation. It may take years for sales to recover, and for consumers to trust the product again. Where could you and your team enhance your standards and processes?
In the first part of this series, I presented some issues with perpetual harvest models for cultivation with respect to inefficiencies in technology and environmental monitoring. I made the case for compartmentalizing cultivation facilities to not only increase energy efficiency, but also to mitigate contamination and control risks for pest incursions. In the second part of this series, I will elaborate on how compartmentalizing your facility can help you stay compliant with pesticide use regulations and promote worker safety.
Problems with Pesticide Use and Worker Safety Regulations
Where there are pests there are pesticides, whether they are low-toxicity materials derived from natural sources or chemical products that are illegal to use on cannabis. Even in the case of growers that are following current pesticide guidelines and using only products approved by their state department of agriculture, perpetual harvest models present issues in ensuring that the workplace is safe for employees and compliant with pesticide use regulations.
One obvious difficulty is the impossibility of containing drift from pesticides applied as foliar sprays. At this point, due to the lack of research performed on pesticides and cannabis, there are currently no defined pre-harvest intervals (PHI), even for products allowed for use on cannabis. A pesticide’s PHI is the number of days that must pass between the time of the last application of a pesticide and when the crop is cut for harvest. While no official, research-based PHIs have been outlined for pesticide use on cannabis, most conscientious cultivators refrain from spraying their crops with anything once flowers have emerged, as the resinous, sticky buds and their many crevices would presumably retain a great amount of any material applied to them. However, flowers do not generally emerge fully until the third week of the flowering process, and many growers apply preventative applications in the first two weeks of flower. In a perpetual harvest facility, what is to stop drift from applications made early in flower from contacting plants close to harvest? One could simply not spray in flower at all, but eliminating early-flower preventative treatments could increase the chances of a pest incursion, which, as discussed above, can be seemingly intractable in this type of facility.
It is important to consider the restricted entry interval (REI) when dealing with pesticide use. The REI of a pesticide is the period of time after an area is treated during which restrictions on entry are in effect to protect people from exposure to hazardous levels of pesticide residues. Most of the products and materials approved for use on cannabis in Colorado have no REI or a relatively short one. At the time I left my former facility, the longest REI for any product in use was twelve hours (for Evergreen Pyrethrum Concentrate), though most had REIs of four hours or less. This issue could be avoided in a perpetual harvest facility by simply always scheduling pesticide applications at the end of the workday; if a product is sprayed at 6 PM, for example, then the treated area should be safe for entry by the following morning when employees arrive. However, what is to be done if a pest incursion is discovered in the middle of the day and an immediate treatment is necessary to prevent its spread? Would the management or ownership of such a facility be willing to clear out the entire perpetual harvest area for 4-12 hours, potentially leaving other tasks unperformed or incomplete, so that a few plants could be sprayed? Even if operators went to such lengths to observe REIs properly, instances such as the hypothetical described above would create massive interruptions in daily workflows and scheduled tasks that are highly undesirable in a well-managed commercial setting. Compartmentalization allows for essential tasks in a single room that might need an emergency treatment to be completed in a timely manner, and cordoned off after the pesticide application to observe the REI.
A final point concerning this topic is that perpetual harvest facility designs make it difficult to observe certain requirements of the Worker Protection Standard (WPS). WPS is administered by the EPA (but is enforced by the Colorado Department of Agriculture (CDA) in that state) and consists of training intended to reduce the risk of pesticide poisoning and injury among agricultural workers and pesticide handlers. WPS training is required for all agricultural workers and pesticide handlers, including those in the legal cannabis industry. One requirement of WPS is that employers provide decontamination supplies for their employees in case of accidental pesticide exposure or poisoning. Sandra McDonald is a pesticide safety expert and owner of Mountain West PEST, which provides WPS and other training to farmers of all crops in Colorado. She states that decontamination supplies cannot be stored in areas that are to be or have been treated by pesticides (such as perpetual harvest rooms, for the purposes of this discussion), as the applications could possibly contaminate the decontamination supplies with pesticide residues, making them useless or even dangerous.
So, in a perpetual harvest facility, where does one store decontamination materials? Again, while there are solutions to this question, they are not ideal. The materials would of course have to be located outside the perpetual harvest room, the entirety of which is a “treated area” at one time or another. But, in facilities the size of the ones under discussion, it could be difficult for an employee who has been exposed to pesticides to reach an eyewash station if he or she has to navigate the expansive perpetual harvest room, as well as a doorway or two, in order to gain access to safety supplies located somewhere that pesticide contamination is not a risk. McDonald notes that most of the products approved for use on cannabis by the CDA would not require immediate decontamination. However, as not to downplay the very real risks posed by some approved products, she also points out that first aid statements on the labels of such pesticides recommend at least 15-20 minutes of continuous rinsing in the case of a worker getting pesticides in his or her eyes, and treatment that takes place sooner rather than later is obviously preferable. Additionally, there are some approved materials with high pH levels that could be immediately damaging if a worker splashed them in his or her eyes.
The issues raised by perpetual harvest designs in respect to pesticide use and worker safety are amplified greatly if businesses operating perpetual harvest facilities employ or have employed chemical pesticides that are illegal for use on cannabis. Unfortunately, the illegal application of restricted-use pesticides has revealed itself to be widespread, as examples from Colorado and Washington illustrate. One of the most commonly used illegal products, Eagle 20EW, carries with it a 24 hour REI. This means that to properly observe this safety measure, employees would be required to keep clear of the treated area for a full day, which I find unlikely to be enforced considering the daily requirements of a cultivation facility. Drift again poses a problem, but a much more serious one compared to the products on the CDA’s approved list.
Recommendations
It should be obvious by now that, when considering facility or site design, compartmentalization is desirable and necessary. This goes for greenhouse and outdoor production, as well as indoor. In fact, some outdoor farmers in the Emerald Triangle area of northern California work multiple, separate parcels to hedge against the threat of crop loss wiping out their entire year’s efforts. Though the discussion above focused mostly on flowering plants; propagation, vegetative, and mother areas should be separate as well, as they effectively contain all future harvests and are therefore of paramount importance.
The appropriate amount of compartmentalization will vary depending on the operation. In most agricultural businesses, some amount of loss is expected and incorporated into plans and budgets. In terms of areas for flowering plants, they should be compartmentalized to an extent that, should a severe infestation or systems failure occur, the loss of expected revenue from one or more rooms or areas will not cripple the business. Such loss should not happen often in a well-run, well-equipped facility. However, I have seen the drastic damage that russet mites can cause, in addition to experiencing the dread that permeates an entirely darkened warehouse after a transformer explosion, and would advise that cash flow projections take into account the possible loss of a harvest or two from a single room per year, just to be safe.
In cannabis farming, as in all agriculture, we must plan for the worst and hope for the best. Compartmentalization is a fundamental and effective safeguard against small pest incursions becoming widespread infestations, while allowing for grow areas to be fully sterilized and decontaminated after a harvest without completely interrupting all operations. It also allows for the observance of REIs, PHIs (even self-imposed ones), and certain WPS guidelines much more easily than perpetual harvest models. Finally, while costing more up front, ongoing operational expenses can be lessened, with a greater return on the energy that is used. While the benefits of wide-open spaces are frequently touted in a variety of contexts, cannabis cultivation is one where being boxed in is preferable to ensure that your employees, plants, and investment are protected.
As your company grows, or whether you want to have certain documentation to make an application for licensure and/or for outside entities looking to invest, it is necessary to handle issues from a documentation standpoint. Learning how to handle situations with staff through proper employee manuals and how to establish and practice standard operating procedures can help businesses avoid common pitfalls with a little forethought.
Beginning with standard operating procedures (SOPs), there are many resources available to get assistance in crafting them. You can consult with individuals such as safety content producers, business consultants, lawyers, technical writers, and even borrowing SOP writers from other industries. I am aware of a Connecticut producer who tapped pharmaceutical SOP writers as consultants with the focus of establishing their standard operating procedures. I am not convinced that there is any proper person or method by which an entity may want to consider an SOP. As a threshold, however, it is important that a proper format is created, i.e., simple steps, hierarchical steps format or perhaps even a flow chart format.
One would want to consider the audience who will be reading the SOP and the information to impart to that audience. It is also important to consider SOPs that you want to update as practices evolve or change.
It is possible to create SOPs internally, and frankly, this may be the most recommended route. If the SOPs are being used for guidance and not just to support the license application process, this is particularly important. It is a time-consuming task and if created from the inside out, it can be most effective.
It is possible to get lost in the minutia by documenting every step taken within a particular process. I have seen SOPs number in the hundreds just for cultivation and processing operations. One particular entity in Colorado created over 63 SOPs within the past year. If you are writing your own SOPs, it is important to understand the scope and applicability, i.e. why a particular process is performed and how it is used, then the procedures and/or steps that are necessary to accomplish that particular process, clarify any terms that are necessary so that the reader is able to follow the steps throughout a particular outline, cover health and safety issues, address equipment and supplies and provide emergency procedures.
The process that I can attest to as being fruitful is interplay between an employee who is actually responsible for a given task and a third party looking from a 1000-foot view. For instance, have the employee who completes a number of tasks within the organization provide a list of what they do on a general day-to-day basis. From that list, have the third party extrapolate what topics might be covered, often times borrowing from other well known standard operating procedures that are seen across industries and come up with a master list of the SOPs which are desired. It is important for the employee and third party to collaborate to finalize SOPs.
Employee guides or manuals provide information on benefits, when time sheets are due, paydays, holidays, vacation days, sick days and more. For employees, it helps mitigate risk by providing guidelines for conduct, discipline, and local practices in the states in which you operate. Employee guides are most effective when they are created to match your company’s needs. When it is tailored to your company, you are certain that the policies meet the laws of the places where your offices and employees are located. It allows you to provide input so you can ensure that you have developed policies that your company will follow. Unwritten policies are unwise as they may cause issues and can potentially lead to lawsuits. There are three types of multi-state employee guides: a guide with favored nations status, meaning that the most liberal laws in one location apply to the entire organization; an employment guide for each location in which you operate; or you can create one guide with a local practice section.
Creation of employee guides is a time consuming and arduous practice, but once completed, they help guide the relationship between employee and employer. Employees should review the employee manual and sign off upon receipt and review. This will serve to protect the employer in the future should an issue covered by the manual arise.
An effective employee guide might include (but certainly not be limited to) the following:
An “employment at will” disclaimer
An anti-harassment policy
An internal grievance procedure
Equal Employment Opportunity (EEO)
Employee benefits
Paid time off (vacation, personal days, sick leave)
Unpaid leaves of absence
Americans with Disabilities Act (ADA) (for employers with more than 15 employees)
Jury duty, military leave
Hours of work
Introductory/probationary period
Legally mandated language concerning pay deductions
Proper E-mail/Internet usage
Professionalism/dress code
Drugs in the workplace
Social media policy
There are many other policies that would be included in order to comply with requirements that might be mandated by a particular regulatory scheme i.e. security compliance. The guide should be a living, breathing document that evolves over time based on new knowledge, changes in laws and business fluidity.
Both standard operating procedures and employee manuals or guides are integral to the viability of a cannabis related business whether a hands on the plant license holder or an ancillary company. I encourage my clients to craft self-created content that they have invested their time and knowledge into, with some help where necessary. Purchasing forms online does not provide a workable format and will only lead to problems in the future. You get what you put in and creating these documents internally and from the ground up gives more control to the business.
When newspapers and television run a cannabis story, it is frequently accompanied by photos or video of vast, cavernous warehouses filled with veritable oceans of plants. Photos used to illustrate stories in the New York Times and Denver Post serve to illustrate this point.
This type of facility design is sometimes referred to in the cannabis industry as a “perpetual harvest” model. This is because plants are harvested piecemeal – one row at a time, for example – with new plants ready to flower replacing the recently harvested ones. In this model, flowering plants of various ages occupy the same space and the room is never completely harvested and empty, hence the “perpetual” moniker. This is in contrast to more compartmentalized facility designs, in which flowering plants are segregated in smaller groups in various rooms, which are then harvested completely before the room is cleaned and new plants ready to flower replace the previous ones.
The perpetual harvest setup appears impressive and lends itself well to portraying the volume of production being achieved in large facilities. This is likely why I have seen such models, or similar ones, copied in other states. Prospective entrants to the industry have also approached my firm with such designs in mind for their cultivation facilities. However, we generally advise against the perpetual harvest facility model, as this type of design imposes serious difficulties upon operators. Problems arise primarily in the areas of pest and contamination mitigation, ability to properly observe pesticide use and worker safety guidelines, and inefficiencies in lighting and HVAC usage. The problems noted are linked to the perpetual harvest design and can be mitigated with increased compartmentalization. Before getting to my recommendations, however, lets run down the issues created by the perpetual harvest model.
In many photos I see of perpetual harvest facilities, the ceilings are extremely high, as are the light fixtures in most cases. This is likely the result of one of the main perceived advantages of such spaces, which is that they require minimal construction prior to getting up and running. There are no walls to be put up or ceilings lowered, and the lack of compartmentalization makes running wires and ducting much easier.
However, whatever capital was saved in initial construction will likely be burned up by increased ongoing operational costs. High ceilings such as those in the above photos mean more cubic footage that climate control systems must cool or heat. Additionally, due to the great height of the light fixtures, plants are not getting the most bang for their buck, so to speak, compared to designs that allow lights to be lowered appropriately to provide optimal intensity and spectrum. Double-Ended High Pressure Sodium (DE HPS) lamps are probably the most common type of lighting in use for flowering by commercial cannabis cultivators today, and they are ideally situated about four feet above the canopy when running at full capacity.
For businesses aiming for a no-frills production model with minimal attention to the light management needs of individual cannabis cultivars (or strains, as they are commonly referred to), then this consideration may be moot. However, those operations attempting to produce the highest-quality flower and plant material know the value of proper light management, as well as the fact that some cultivars respond differently than others to intense light. Indeed, I have observed cultivars that produce more when light intensity was decreased, while others thrived under intense light that would have seriously damaged others. This makes the one-size-fits-all approach to light management I’ve seen in most perpetual harvest designs generally detrimental to the quality of the final product, in addition to using the same amount of energy, or more, to achieve that lower quality result.
Difficulties in Pest and Contamination Mitigation
Such a design makes it easy for a small pest incursion to become a full-blown infestation. Because plants about to be harvested are sharing space with plants just beginning their flowering process, this means that both current and future harvests will be affected, or even lost entirely if the pest problem is severe. Having plant groups of different ages share the same space is generally unadvisable. This is because older plants, particularly those close to harvest, are weaker and more susceptible to pests by virtue of the fact that their life cycles are nearing an end. On the other hand, a more compartmentalized facility design provides physical barriers that can contain mites and mildew spores to some extent, limiting the damage done by individual pest incursions.
One of the essential tasks in an indoor cultivation operation is sterilizing just-harvested spaces to ensure that the subsequent run gets off to a clean start. This task could conceivably be performed in a perpetual harvest model; say, for example, trays, trellis frames, and other equipment are scrubbed after a row has been cut down and removed for drying or processing. However, due to the fact that there are always other plants in the room, it seems impossible for any plant group to get an assuredly clean start, as other plants may be harboring bugs, mold spores, or viruses, despite not showing signs or symptoms. The presence of plants also eliminates the possibility of using cleaning agents such as bleach, which gives off harmful fumes, but is sometimes necessary to completely sterilize an area that might have previously experienced some amount of powdery mildew or botrytis.
In Part II of this series, I will discuss some problems with pesticide use and worker safety regulations as well as provide recommendations for compartmentalization in cultivation facilities. Stay tuned for Part II of A Case for Compartmentalization: Problems with “Perpetual Harvest” Models in Cultivation, coming out next week.
Eurofins-Experchem Laboratories is a Health Canada and FDA-accredited analytical laboratory with a regulatory support division. The laboratory carries out testing for many different sectors including pharmaceuticals, cosmetics, natural health products and medical devices. Starting in 2014, cannabis testing was incorporated into the mix. One reason our results so accurate is due to rigorous staff orientation and training method. Diligent staff training and monitoring is very important for success as a Good Manufacturing Practices (GMP) facility with a Drug Establishment Licence and Narcotics License. So what does that look like on the inside? Saif Al-Dujaili, our quality assurance manager, Sohil Mana, our vice president of operations, and I will provide some guidelines for developing training programs below.
Introductory Session: When any new employee starts an introductory phase, it begins with general admin, a facility tour, policy manual training, govt. legislation overview and health and safety training and orientation (WHIMS and Bill 168) specific to our lab. We record signatures on any pertinent forms for SOPs that the new employee will be using.
Standard Operating Procedures: Any new employee must read all related SOPs and is evaluated on their understanding of them through questionnaires/quizzes. SOPs are written for all equipment, instrumentation or process that is applied in the lab, to ensure consistency across operations.
Laws and Regulations: New employees must be familiar or familiarized with Good Manufacturing Practices and Good Laboratory Practices. Analysts are required to read all sections of the USP pertinent to their role, as decided by the quality manager and/or dept. head and a checklist is recorded on training.
Methods: Different methods are used to test products including Compendium or other published methods with organizations such as the Association of Analytical Communities (AOAC) and the American Chemical Society (ACS). Client Methods and house-developed methods are also used. If there is a change to any method, a change control form must be filled out and documented.
Documentation: Documentation is very important in a GMP lab. All data is recorded in a hard cover bound book and/or approved worksheets. Quality assurance data reviewers are responsible for ensuring all data is being recorded properly.
Sample Management: Employees are trained on sample management related to sample entry, how samples are distributed to analysts, turn-around time, and where finished projects are placed.
Training Forms: Everything an employee learns must be recorded and filed for records. Analysts must follow a training matrix on qualitative and quantitative testing methods. Recurrent training occurs each 3 years or less depending on the position the analyst holds. Any updates on GMPs, new instruments or equipment is ongoing and recorded. Experchem runs “ghost” samples through its laboratory to ensure compliance by employees at any given time. Employees are evaluated on their abilities to comply.
Ongoing Training: Once employees are up and running they also receive monthly training in the lab and an annual GMP training followed by a comprehensive quiz that must be passed for them to continue work.
Interested in learning more about cannabis testing in Canada and the US? Contact Tegan Adams, business development manager with Eurofins at teganadams@eurofins.com.
The Supreme Court shut down a lawsuit on Monday brought by two states against Colorado for its recreational cannabis laws. Nebraska and Oklahoma brought the case to the Supreme Court, claiming that the recreational cannabis industry in Colorado is responsible for the illegal exportation of cannabis outside of Colorado. “Colorado has facilitated purchase of marijuana by residents of neighboring states by issuing licenses to an unusually high number of marijuana retailers perched on Colorado’s borders,” the two states told the court in a supplemental brief.
In that brief, the two states argue that Colorado’s cannabis industry led to more cannabis illegally crossing state lines. They argue because of that influx of cannabis, they spend more on law enforcement and state resources, which is a detriment to their citizens. The Supreme Court did not provide an explanation for why they refused to hear the case.
Many view this as a big win for the legal cannabis industry. “The Supreme Court has protected the will of the people today and I believe the court has demonstrated that it understands legal cannabis is a fundamental right,” says Andy Williams, president of Medicine Man, the largest cannabis dispensary in Denver.
Still others see this simply as business as usual. “While I’m pleased to see the Court reject the challenge to Colorado’s cannabis law, this decision isn’t really a win for cannabis advocates- it only maintains the status quo,” says Aaron Herzberg, partner and general counsel at CalCann Holdings, a medical cannabis holding company specializing in real estate and licensing. “We are struggling with diversion in California, so hopefully states will continue to be on track to create a more regulated and taxed environment where cannabis can be manufactured and sold through channels where it is safe and tested,” continues Herzberg.
Adam Koh, chief cultivation officer at Comprehensive Cannabis Consulting (3C), warns that the Court’s denial to hear the case is not necessarily an affirmation of state’s cannabis programs. “It is evident that some diversion is taking place, which of course is against the provisions of the Cole Memorandum,” says Koh. “In order to avoid being implicated in such activities, legally licensed cannabis businesses in Colorado should not take the SCOTUS decision as a signal to relax, but should instead work to make sure that inventory control and record-keeping protocols are in place and even exceed the standards required in state regulations.”
The fact alone that Nebraska and Oklahoma even brought the case to the Supreme Court means that diversion is a major issue facing the cannabis industry. “Only by going above and beyond in terms of compliance will this controversial industry make itself credible in the eyes of its detractors,” says Koh. Some cannabis industry leaders take it upon themselves to help guide rule makers in crafting standards.
Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), believes the Cole Memo is currently the best guidance for states and business owners to follow by the federal government in regards to cannabis. “Gaping holes in cannabis regulations are glaringly identified via the pesticide issues and recalls recently,” says Engelking. “These issues showcase each state being in violation of the Cole Memo’s expectation that they will implement strong and effective regulatory and enforcement systems that address the threat to public safety, public health, and other law enforcement interests.”
The Supreme Court’s denial of the two states’ challenge to Colorado’s cannabis legislation suggests the federal government’s intentional avoidance of involvement in current state cannabis issues. The government’s inaction does not, however, indicate their support.
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