An explanation of the causes of potency loss in infused beverages from either a chemical or physical route.

Potency Loss in Cannabis Beverages

Articles

This application note discusses the different methods of using calibration weights and when to use each type.

Calibration vs Verification

The U.S. House of Representatives passed a bill recently that will aid researchers with gaining access to cannabis that is available commercially in states where it is legal recreationally or medically (1). Previously, researchers were only able to use cannabis that was supplied from a federally licensed manufacture in Mississippi, specifically the University of Mississippi.

Deeply embedded in the infrastructure bill (2), the main goal of this provision is to allow cannabis products to be transported and distributed across state lines. This also includes states that have not yet established state-legal cannabis markets. The bill is called the “Invest in America Act.” The bill also requests that states with cannabis programs need to establish structures regarding driving under the influence of cannabis to educate their residents.

According to a report from Cannabis Newswire, the section on setting up highway safety education programs was not well received by cannabis law reform advocates (1). Cannabis Newswire cited several reasons for this (1) including that the report was authored by a congressional research team who stated that there wasn’t any conclusive evidence that the consumption of marijuana resulted in impaired driving.

Discussions of the bill on the Congress floor granted the suggestions of other amendments to be adopted or rejected. Regardless of the deliberations, cannabis policy reform advocates were excited for researchers to gain more access to commercially available cannabis in states with regulated cannabis markets.

The National Organization for the Reform of Marijuana Laws (NORML) explained that it has been hard to comprehend why scientists couldn’t access the cannabis available in state-legal dispensaries, yet ordinary residents could walk in and buy these products (1). “Scientific research needed to be conducted using the same products that people are consuming in order to get results which were applicable to the community,” said NORML (1).

All eyes are on the Senate on whether they will preserve the pro-marijuana provisions in the transportation bill. In addition, the Drug Enforcement Administration (DEA) has reportedly taken proactive steps to expand the number of suppliers of research-grade marijuana products.

https://www.cannabisnewswire.com/420-with-cnw-congress-passes-bill-granting-researchers-access-to-commercially-available-marijuana/

https://www.congress.gov/bill/116th-congress/house-bill/2

The U.S. House of Representatives passed a bill recently that will aid researchers with gaining access to cannabis that is available commercially in states where it is legal recreationally or medically.

Congress Passes Cannabis Provision in New Infrastructure Bill

Recently, the formation of a group called the Legal Cannabis Coalition (LLC) was announced (1), which consists of a dozen Dutch horticultural companies. During the past two years, these companies participated in a joint scientific study to optimize greenhouse cultivation of medicinal cannabis that was organized by Wageningen University & Research (WURR) in The Netherlands. Here, Jan Mol the sales Director at Oreon, his company’s role in the LCC, light-emitting diode (LED) lighting, research and education initiatives, and more.

How did you first get involved in cannabis cultivation?

 Oreon is a developer and producer of LED lighting. We started in 2005 with LED lighting for domestic use. In 2006 Street lighting followed and in 2009 we were the first to introduce LED lighting for greenhouses. In our design we combined the generic characteristics of LED lighting (long life span and low energy consumption) with specific demands of growers. They wanted independency of light and heat, a balanced climate in general, the right spectrum for their crops, and a very compact fixture that could hang under the trusses and minimized shade. The result was our water-cooled fixture. Since then this fixture has been used over various crops such as lettuce, herbs, and tomatoes.

With the prospect of legalization of the cannabis market in various countries, we anticipated on the demand for high light levels. High light levels also mean possible heat problems, which is something that we have solved. No extra radiation heat of the fixtures in the greenhouse. This together with the highest efficiency (3.4 uMol/Joule), an output per fixture of 3400 uMol/s, and the small size of our fixture made our product very attractive for the legal cannabis industry.

Can you tell us more about the Legal Cannabis Coalition (LCC)? How did it form and what are the goals of the group? How much collaboration is involved from the various parties in the group?

 Together with the Wageningen University and Research (WUR), Oreon started to test their fixtures on cannabis in 2016. We followed the developments in legalization in various countries and wanted to be able to answer the specific questions of growers. Besides that, we wanted to know in what way our fixtures (and spectra) had advantages compared to other lighting, for example, sodium lighting. That is why we started the trials. Over the years, more and more, best in class suppliers of horticulture products wanted to test their products. That was the moment that we decided that combining our individual efforts resulting in more and bigger research was in best interest of the individual companies and our clients. During the past 4 years, we have been testing on a large scale and on multiple crops per year. Researchers of WUR, led by Filip van Noort, gathered so much information on various areas from screening, light (intensities), nutrition, soil, substrate, temperature, RV, grow systems, plant resistance, laboratory science, pharmacy, and so forth that we decided to combine this information and make it available to our customers through a centralized organization. Behind this combined information there is the individual knowledge of the members. That is why we started the LCC. As individual members we already tried to work together as much as possible, but now our common knowledge is available through a professional organization: The LCC.

What kind of educational efforts are you involved in with the LCC?

 Oreon concentrates on lighting. Our developments are being tested at WUR, integrated in the entire grow system, and evaluated together with other results by the various members of the LCC. The goal is to provide our customers with the best information possible based on actual data and tests.

How will the LCC’s research efforts impact other cannabis research or help the industry develop further?

 Within the LCC a wide range of disciplines are combined. From building a greenhouse and installing lights, to quality testing and pharmaceutical development of the harvested cannabis. The collective knowledge, in combination with the various research licenses the members of the LCC hold, allows multidisciplinary research projects. Research is done with LCC members, but also companies and universities from outside. Through consulting as well as education services, this knowledge benefits LCC’s customers and therefore the industry.

What is the biggest challenge facing cannabis cultivators? Are there unique challenges for medicinal cannabis cultivators?

 The biggest challenges are standardization of the cannabinoid and terpene content of the cultivated cannabis (especially for medicinally used cannabis), and lowering the cost of production because of more intense competition with cultivation in low cost countries, and cultivation outside in the field. Also lowering energy consumption of the lamps, not only for cost, but also for environmental impact, is another challenge.

Can you tell us about the technology behind your company’s water-cooled LED lights?

 Of course, in how many words? A plant needs light to grow. Our goal is to provide light in the most efficient way. In general, that means the right spectrum, the highest output, the best uniformity, the smallest fixture ,and no (negative impact) on the climate in the greenhouse because of radiated heat. The result is a perfect grow against the lowest cost. Besides growing advantages, the water cooling also has many economic advantages such as longer lifespan, possibility of re-use of the heat, and savings on cooling and CO2 costs.

What benefits do water-cooled LED lights offer compared to other LED lights on the market?

 LED’s need to be cooled. In general, this can be done in two ways: passively and actively. The cheapest is to put them on a heat sink that radiates its heat to the air. More power results in more heat and a bigger heatsink. That is something you don’t want in a greenhouse because you do not want to block the light from the sun. Besides that, the fixture and electronics still stay quite hot which doesn’t support durability.

The best way to cool a led fixture is to use water. By using water both the LED’s and the electronics are being cooled in an optimal way. This ensures durability, a small fixture, and no extra heat in the greenhouse or facility.

What are your plans for the future with the LCC or LED lighting for cannabis?

 We want to continue supporting cannabis research organized by the LCC and support collaboration between the various members of the LCC. We think that is in the best interest of our mutual customers, the industry, and therefore in the interest of the individual companies.

https://www.oreon-led.com/cache/PRESS%20RELEASE%20Horticultural%20companies%20and%20scientif.1390/PRESS%20RELEASE%20Horticultural%20companies%20and%20scientif.pdf

Jan Mol the sales Director at Oreon, discusses his company’s role in the Legal Cannabis Coalition (LCC), light-emitting diode (LED) lighting, research and education initiatives, and more.

The Legal Cannabis Coalition, Part II: An LED Company’s Perspective 

 has partnered with Marijuana Business Daily® to host an extraction meetup on Tuesday, June 30 from 3-4 p.m. MDT at its 2020 

 concurrent virtual conferences and expos.

The conferences, originally planned as in-person events, were transitioned to a virtual format due to the COVID-19 pandemic and will take place June 29-July 1, offering a state-of-the-art digital environment for attendees to connect, learn, discuss and chart the future of the industry. Various networking opportunities will be available through themed meetups and roundtables, as well as Network Builder, an innovative artificial intelligence tool that creates personalized meeting recommendations based on an attendee’s profile and interests.

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Conference registration is open until July 1 and includes:
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“We are excited to get the extraction meetup underway, share our knowledge and learn from others in the industry about their extraction wins and the challenges they have faced,” said Megan L’Heureux, editor-in-chief of C

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To register for the MJBizConNEXT Direct/Hemp Industry Daily Conference Direct 2020 sessions, 

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 is a multimedia platform that focuses on educating the legal cannabis industry about the science and technology of analytical testing, quality control, extraction and cultivation. The magazine is accompanied by an online component and provides relevant information and tutorials for all members of the cannabis industry. 

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Marijuana Business Daily® also serves as produces and hosts the world’s largest family of B2B trade shows for the cannabis industry, including their flagship MJBizCon, MJBizConNEXT, Hemp Industry Daily Conference and various cannabis symposiums worldwide. Recent recognition and awards include Trade Show Executive’s Fastest 50, The Inc. 500, Inc’s 2020 Private Titans, and Folio Magazine’s Women in Media. Marijuana Business Daily® is also a proud member of the Associated Press.


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Multimedia platform will host extraction meetup at MJBizConNEXT Direct and Hemp Industry Daily Conference Direct online conferences and expos.

 Cannabis Science and Technology® Partners with Marijuana Business Daily® to Kick Off Virtual Events for Hemp and Cannabis Industry Executives 

The lack of cannabis standard reference materials means the phenomenon of inter-laboratory error is still with us. This problem is so bad it means results from different laboratories should not be compared to each other. The good news is that their finally exists a proper set of hemp standard reference materials courtesy of the University of Kentucky. The implications of this for hemp testing are discussed.

The inter-laboratory error problem strikes again. Myself and others have researched and written extensively on that problem in the cannabis analysis industry (1–7). This problem occurs when different laboratories obtain markedly different results on the same samples. Unfortunately, the problem is still with us as seen in Tables I and II, which show the total tetrahydrocannabinol (THC) and total cannabidiol (CBD) measurements on a set of three hemp samples sent to two different laboratories. 

Both laboratories S and N are fully state licensed, International Organization for Standardization (ISO) certified, and enjoy a good reputation in the cannabis industry. If we had the right level of standardization, these two laboratories would obtain the same results on the same samples within their margin of error (8). The results in Tables I and II clearly show this is not the case. The standard deviation for total THC between the two laboratories is 0.11 wt.%. This may seem small and acceptable. However, legal hemp cannot contain more than 0.3% total THC by dry weight (9,10), and the inter-laboratory error (standard deviation) of 0.11%, when divided into 0.3%, represents a relative error of 36.6%. This is way too large to be thought accurate. The inter-laboratory error is particularly acute for the sample C4 listed in Table I. Laboratory S found 0.33% total THC, while Laboratory N found 0.21% total THC. The difference of 0.12% means Laboratory S says the material is illegal, whereas Laboratory N says it is legal. Thus, the choice of laboratory determines whether a hemp farmer can sell their crop or not. Who are we to believe here?

The situation for total CBD measurements is worse, as seen in Table II. This value is used to determine hemp prices. The standard deviation between the two laboratories is 2.1 wt.% total CBD. This much of a difference can cost hemp farmers thousands of dollars when they go to sell their crop. Again, the choice of laboratories determines the success or failure of the hemp farmer. Who are we to believe? The livelihood of thousands of farmers, and millions of dollars, are at stake each harvest season, and depend upon the accuracy of these measurements. The ongoing problem of inter-laboratory error means that our cannabis testing regulatory framework is inadequate and needs to be fixed (6).

The inter-laboratory error problem has real world consequences whenever cannabis materials are bought and sold. Imagine a hemp deal where the total CBD value is going to determine the price. The seller may have a certificate of analysis for the material that says the total CBD is 7.54%, and the buyer may have the material analyzed at their laboratory which finds a total CBD value of 4.73%, a difference of 2.81%. This is exactly the case for sample Mountain Mango seen in Table II, so the problem is real. Whose value should be used to determine the sale price? A solution to this problem is for the buyer and seller to agree upon whose measurements they will trust prior to the transaction.

The Search for Cannabis Standard Reference Materials

One of the causes of inter-laboratory error is the lack of cannabis standard reference materials (SRMs) (5). This would be a set of samples whose composition the stakeholders in this industry can agree upon. These samples could then be used in round-robin studies to compare laboratories, ascertain method quality, and research new testing technologies.

In the United States the National Institutes of Standards and Technology (NIST) is the Federal agency tasked with generating SRMs for industry (11). For example, NIST supports the green tea industry with a standard reference material (12). This means NIST knows how to create SRMs for agricultural crops. It would make sense then that NIST would create SRMs for the cannabis industry. However, recall that at the Federal level all cannabis plant material with a total THC value of greater than 0.3% is considered marijuana and is illegal (9,10). Thus, it would be against Federal law for NIST to develop SRMs for marijuana analysis. But there is nothing preventing NIST from developing SRMs for legal hemp. They are in fact developing such materials (13). However, it may be some time before these SRMs are ready.

The lack of SRMs affects our ability to calculate accuracies in cannabis analysis. But first, we need to clarify how “accuracy” should be calculated for chromatographic cannabis potency measurements. Typically, chromatographs are calibrated for potency using solutions of cannabinoids of known concentration (14–16). This is appropriate because due to the sample preparation required for chromatography, the sample being injected into the chromatograph is a solution of cannabinoids. In this case, the true value comes from the known amounts of cannabinoids in the pure standards, and an accuracy calculation is possible. Impressive potency measurement accuracies are possible when analyzing pure cannabinoids (14–16).

The lack of appropriate SRMs makes it impossible to calculate a true accuracy value for real cannabis samples. This is why I say the concept of accuracy is a myth in cannabis analysis. This, combined with variations in method across laboratories, is why you can’t compare numbers across laboratories. The inter-laboratory error, documented for example in Tables I and II, is too large.

At the end of the day the problem isn’t that one laboratory’s method is “right” and some other laboratory’s method is “wrong.” The problem is that the lack of SRMs and standardization means that no two laboratories use the same exact methods, which means no two laboratories are going to get the exact same result on the same samples.

This does not mean precision measurements cannot be made. Recall that precision is a measure of reproducibility (8). A laboratory could determine its method’s precision by analyzing multiple aliquots of the same sample and then comparing the results. This measurement, and not how well a method analyzes pure standards, is for now the best measure we have of cannabis analysis method quality.

The search for a set of SRMs for hemp is over. The University of Kentucky (UKY) has developed a set of hemp standard reference materials as part of their Hemp Proficiency Program (HPP) (17). This sample set consists of four legal hemp samples, each of which has been analyzed by dozens of cannabis analysis laboratories across the country. The certificates of analysis that come with these samples contain the average total THC, total CBD, and other cannabinoid weight percents as determined by these laboratories.

I have vetted these SRMs by sending three aliquots of each sample for high performance liquid chromatography (HPLC) analysis to a laboratory I trust, SC Labs of Santa Cruz, Califronia (18). The purpose was to assess the homogeneity of the samples. The results for total THC are seen in Table III. 

The difference between triplicate analyses of the same sample are in the third decimal place. This indicates the UKY hemp samples are homogeneous. This is impressive considering how inhomogeneous hemp plant material is, and how hard it is to render these samples uniform.

My other way of assessing the quality of the UKY samples was to see how well their values compared with those of SC Labs. The results for total THC are seen in Table IV. 

Note that the differences are on the order of 0.03 wt.%. This excellent agreement convinces me that the weight percent cannabinoid values on the certificates of analysis that come with the UKY samples are correct.

This means we finally have an independent set of hemp SRMs-a set of hemp plant material samples with true cannabinoid content values. This sample set allows true accuracy calculations to be made, individual laboratories can evaluate their methods by comparing themselves to true standards, inter-laboratory round-robin studies can be performed to evaluate different methods, and a sample set exists with which to compare results from new testing technologies (19).

I strongly encourage all cannabis testing laboratories in the US interested in testing hemp to analyze this sample set, and participate in the University of Kentucky’s Hemp Proficiency Program (17).

The problem of inter-laboratory error continues to plague the cannabis analysis industry. This makes it difficult, for example, to set the purchase price for cannabis materials. A part of the problem is the lack of cannabis standard reference materials. Fortunately, the University of Kentucky has developed a set of hemp validation samples as part of their Hemp Proficiency Program. I have vetted these samples and am convinced they are legitimate. The hemp testing industry should be using these samples in round robin studies to ascertain method and laboratory quality, and develop new and better cannabis analysis methods.

M.O. Bonn-Miller, M.J.E. Loflin, B.F. Thomas, J.P. Marcu, T. Hyke, and R. Vandrey, 

https://www.seattletimes.com/seattle-news/marijuana/some-pot-labs-in-state-failed-no-pot-at-all-says-scientist/

https://www.nbcbayarea.com/investigations/Industry-Insiders-Warn-of-Fraud-at-Marijuana-Testing-Labs-458125743.html?_osource=SocialFlowFB_BAYBrand

115th United States Congress, Senate Bill S.2667, ”Hemp Farming Act of 2018.”	

https://www.federalregister.gov/documents/2019/10/31/2019-23749/establishment-of-a-domestic-hemp-production-program.

https://www.nist.gov/publications/development-and-certification-green-tea-containing-standard-reference-materials

https://www.nist.gov/programs-projects/nist-tools-cannabis-laboratory-quality-assurance

M.W. Giese, M.A. Lewis, L. Giese, and K.M. Smith, 

T. Ruppel and M. Kuffel, “Cannabis Analysis: Potency Testing Identification and Quantification of THC and CBD by GC/FID and GC/MS,” PerkinElmer Application Note, 2013.	

is Founder, CEO, and Chief Technical Officer of Big Sur Scientific. He is the inventor of the BSS series of patented mid-infrared based cannabis analyzers. Dr. Smith has done pioneering research and published numerous peer-reviewed papers on the application of mid-infrared spectroscopy to cannabis analysis, and sits on the editorial board of Cannabis Science and Technology. He has worked as a lab director for a cannabis extractor, as an analytical chemist for Waters Associates and PerkinElmer, and as an analytical instrument salesperson. He has more than 30 years of experience in chemical analysis and has written three books on the subject. Dr. Smith earned his PhD on physical chemistry from Dartmouth College.

A proper set of hemp standard reference materials courtesy of the University of Kentucky are now available and the implications of this for hemp testing are discussed.

Hope on the Hemp Testing Horizon

Cannabis or hemp extraction typically involves the use of hazardous materials, including flammable liquids, gases, or vapors. The use and storage of these hazardous materials, coupled with the complex electrical systems and equipment utilized in extraction facilities, leads to a myriad of safety hazards that business owners must be aware of. This article explores hazardous location requirements and hazardous area classification as they relate to extraction facility design and construction, specifically diving into the National Fire Protection Association (NFPA) code 497. Some of the topics we discuss in this article include: equipment and safety standards required to be implemented in hazardous areas and important considerations when making these decisions; how to ensure compliance with local jurisdictions and other governing bodies; building the right team of experts to ask the right questions and avoid common pitfalls; important equipment and space considerations to keep top of mind before purchasing any equipment; and hazardous area classifications and what that means for your facility.

Hemp and cannabis extraction facilities typically use a variety of hazardous materials in the extraction and refinement processes. These materials can include ethanol, methanol, propane, butane, hexane, heptane, and pentane-among others. Carbon dioxide may also be used, and although it isn’t flammable or explosive, it is an asphyxiant, which can cause suffocation to occupants and therefore comes with its own life-safety considerations. When it comes to hazardous materials, it is important to understand the quantity of each material used and stored in your facility. It is these quantities that will determine the type of construction required for your facility and can dramatically affect construction costs.

Control Areas and Maximum Allowable Quantities

Many facilities can avoid a hazardous classification if they can limit the use and storage of hazardous materials to specified control areas (or rooms). A 

 is a term used in the building codes and is defined as a portion of a building within which hazardous materials are allowed to be stored, dispensed, used, or handled in quantities not exceeding the maximum allowed quantities (MAQ). The number of control areas is limited by the building codes, and is determined by the quantities and types of hazardous materials used and stored within your facility.  If your process requirements can stay within the MAQ, the building may not need to be classified as a hazardous occupancy (that is, H occupancy), which may avoid the higher construction costs associated with a hazardous occupancy building classification. Instead, specified control areas within the building will be designed as hazardous classification areas where any hazardous materials are used or stored. For example, your extraction process may be contained within one such control area. Your isolation process may be contained within another. Bringing qualified and experienced architectural and engineering professionals to your team early can help you determine the MAQ for your materials and processes, and point the way toward the best and most cost effective design path for your facility.

If your facility and processing goals are large enough, you may require solvent and other hazardous material quantities that are greater than the MAQ allowed within building control areas. When this is the case, the entire building will need to carry a hazardous occupancy classification. Such a building will have increased setback requirements from property lines and will be subject to more stringent building, mechanical, and electrical code requirements. However, there will be no limits placed on the quantities of hazardous materials that can be used and stored in your facility. This can be a huge advantage for large extraction facilities. Here again, a qualified and experienced engineering team can help you navigate the stricter code requirements surrounding such a facility.

The National Fire Protection Association (NFPA) code 497 addresses the classification of flammable liquids, gases, and vapors and of hazardous locations for electrical installations in chemical process areas, and has been adopted by most jurisdictions (1). Most extraction and refinement areas are classified as Class I, Division 1 (CID1) or Class I, Division 2 (CID2) spaces. NFPA 497 defines a CID1 space as a location (1) “in which ignitable concentrations of flammable gases, flammable liquid-produced vapors, or combustible liquid-produced vapors can exist under normal operating conditions . . .” NFPA 497 defines a CID2 space as a location “in which volatile flammable gases, flammable liquid-produced vapors, or combustible liquid-produced vapors are handled, processed or used, but in which the liquids, vapors or gases will normally be confined within closed containers or closed systems from which they can escape only in the case of accidental rupture . . .” The essential difference between the two classifications is whether or not a flammable concentration of liquids, gases, or vapors can exist during the normal course of operation. By this definition, many extraction spaces will likely be categorized as CID2, but there are nuances that must be taken into consideration when selecting extraction equipment and locating that equipment within your extraction spaces. These nuances can have a considerable effect on your electrical design and can drive up your electrical construction costs if not dealt with properly.

Most jurisdictions will not allow open loop extraction systems because of the serious life-safety concerns they raise. But even closed loop systems can become “open” at certain times during the process. For example, what happens when you open the lid of your extraction vessel to remove the filter bags of spent hemp? The hemp still contains residual ethanol in small quantities, and that ethanol is now free to evaporate into the room. This constitutes an open system at that location, albeit only for a short period of time. NFPA 497 provides guidance on how such situations are to be handled. See Figure 1.

In this example, opening the vessel creates a situation similar to the vent shown in Figure 1 from NFPA 497. Notice that there is a 3-ft. radius around the vent location that is classified as CID1, and an additional 2-ft. radius that is classified as CID2. Also note that the CID2 zone extends for a distance of 10 ft. at a height of 18-in. above the floor. Any below-grade locations within that zone become CID1. Understanding and applying this figure to the electrical requirements in an extraction room can have a major impact on the overall room design. For example, suppose your extraction vessel is on an elevated platform that is 5 ft. above the floor, and the vessel opens from the top 3 ft. above the platform. If the room ceiling is 12 ft. high, any lights over the vessel will have to be CID2 rated. A lower ceiling may require the lights to be CID1 rated, and there is a big difference in cost for CID1 lights. If the vessel is near a wall, then a portion of the wall will be within the CID1 and CID2 zones. Any outlets in those areas would have to be rated appropriately. What about other equipment located within the classified zones shown in Figure 1? Such equipment would be required to be rated for use in a classified environment, and the power connection to that equipment would also have to be so rated. Other equipment in the room may also create overlapping classified zones. It is apparent that great care must be taken when laying out equipment within an extraction room. Sometimes designers will default to declaring that the entire room must be classified as CID1 or CID2, but this is not required by the code, and can unnecessarily lead to increased construction costs. It is also worth noting that NFPA 497 contains many other diagrams that may apply to equipment in an extraction facility. An experienced engineering team can provide guidance in ensuring that your extraction room and all other control areas are properly designed to account for CID1 and CID2 zones within those spaces.

Understanding the various codes surrounding hazardous materials, control areas, zone classifications, and other critical factors that apply to designing and constructing an extraction facility can be a daunting task. Furthermore, code officials have the authority to interpret these codes as they see fit. Bringing the code officials into the design discussions as collaborators early on can have tremendous benefits for the project, saving time and reducing frustration. Engaging with an experienced and knowledgeable architectural and engineering team will facilitate working with the code officials to ensure compliance. They can ask the right questions and avoid serious pitfalls during the design and permitting process, and can work with you to ensure that construction goes as smoothly as possible.

https://www.nfpa.org/codes-and-standards/all-codes-and-standards/list-of-codes-and-standards/detail?code=497

 has nearly 30 years of mechanical engineering experience working on a diverse range of projects. His engineering experience includes a space launch complex, oil refinery, nuclear power plant, and building heating, ventilation, and air conditioning (HVAC) systems for hospitals, schools, dental clinics, veterinary clinics, churches, restaurants, offices, multi-family housing, retail, and industrial facilities. When recreational cannabis was legalized in Oregon, Rob applied his extensive experience to learning about this industry and its unique design nuances with the team at 

.. Today, he has successfully designed HVAC systems for dozens of indoor grow and processing facilities in need of cannabis engineering.

This article explores hazardous location requirements and hazardous area classification as they relate to extraction facility design and construction, specifically diving into the National Fire Protection Association code 497.

Hazardous Location Requirements for Chemical Process Areas in Extraction Facilities

The cannabis industry has been a hot topic of discussion over the last few years with the push for cannabis legalization around the world. It has been considered the most novel, brand new, and untested agricultural market in decades. But, what has been forgotten is that cannabis is not a new product, nor has it just appeared in the agricultural world. Cannabis was one of the largest agricultural crops in the United States up until its prohibition, and as such was a part of the 

 (USP) compendium for almost a century. This column examines the history of cannabis in the US and the role the USP played in that field. We also discuss the new role the USP is taking in bringing the research and safety back into its scope including its most recent work and developments for the safety and quality of the cannabis for medical use.

Despite the fact that cannabis is treated like the newest botanical product to come to market in decades, cannabis has a long-standing history going back before 3000 B.C. with the first recorded uses in China. Early cannabis products were hemp fibers and medicinal treatments were prescribed by ancient Greek and Roman physicians. In the 16th and 17th centuries the use of cannabis continued and increased with its expansion to the Americas in the 1600s.

 in 1753 as other scientists and physicians included cannabis in world dispensatories. In the US, cannabis products were part of the history for centuries with even our founding fathers growing cannabis crops (Figure 1). 

It has only been within the last 100 years that cannabis was consigned to the shadows of illicit and banned materials in the US and around the world. During the 19th century and the early 20th century, cannabis rose to widespread use, but also became the object of restriction around the world.

In 1906, the US Pure Food and Drug Act required labeling products that contained psychogenic substances such as cannabis and alcohol. By 1914, the Harrison Act (US) made the use of marijuana (a variety of cannabis that contains higher levels of tetrahydrocannabinol [THC]) and other narcotic drugs a crime. Starting in 1915 through the 1930s the prohibition and criminalization of cannabis continued all over the world. In 1937, the US Marijuana Tax Act criminalized cannabis without distinguishing between cannabis with psychotropic properties or species used for hemp products (1).

Despite its illicit status, the research into the medicinal uses of cannabis continued. Many medical applications have come to light and have been shown promising by the scientific methods, including its use as an analgesic for glaucoma and cancer patients. Now in the 21st century, countries around the world are rediscovering the beneficial and medicinal properties of cannabis and pushing for legality. Governments and regulatory agencies have begun to introduce or reintroduce cannabis into their catalog of botanical and agricultural products. One of the organizations actively involved in increasing our knowledge and understanding of cannabis is the United States Pharmacopeia (USP).

The USP is an independent, nonprofit organization outside of the US government whose purpose according to their missions statement (1) is “to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.”

The USP was founded in 1820 by physicians whose intent was to bring a national set of standards to the US that would unify the quality of drugs in the nation. At the time of the initial organization of the USP, most drugs were based on botanical or mineral ingredients. The US needed its own 

 (a compilation of standards and quality specifications that can test to confirm: composition, identity, purity, and strength of specified materials for use in medicines and food products) (2). The first national 

Pharmacopoeia of the United States of America

 (1820) contained a list of 217 drugs that included 145 botanicals and botanical products.

 included updates, omissions, and additions of materials as research progressed or regulations changed. This process was observed in the case of cannabis, which first appeared in the 1850 edition of the 

 until it was dropped from the pharmacopeia by 1940.

started as the primary compendium document produced from the USP Convention, which over the years has changed but persisted since its inception. The modern USP Convention is composed of three principle bodies:  The Convention Membership, Board of Trustees (BoT), and the Council of Experts (CoE). The Convention is a group of up to 600 delegates representing academic institutions, health professionals, scientific and public interest organizations, state and national associations, agencies of the federal government, and many others. The Convention is governed by the Board of Trustees and advised by the Council of Experts.

The BoT assesses the proposed resolutions and shares the findings with The Convention. The BoT also makes the decisions about policy, finances, and the strategic direction of the organization. The CoE is elected to membership by the convention. Each CoE member serves as a chair for an expert committee for five years. The members share their knowledge, develop standards, and review the work plans for their committee. There are many groups and subgroups within the USP CoE working on a range of topic groups for chemical analysis and dietary supplements (Figure 2). 

The work cycle for the organization begins with the need for guidance, methodology, or standards for a new industry, product, or process (Figure 3). USP scientists and industry collaborate to draft a standard or guidance document. The draft is reviewed by experts and upon agreement posted for public review, which lasts 90 days. The comments and draft are then reviewed by the CoE and either approved or sent back for revision. Once approved the monographs, chapters, and other standards are published. Editions of the 

United States Pharmacopeia - National Formulary (USP-NF)

 are published on an annual basis. USP standards are reviewed regularly and revisions are published frequently. 

 contains two primary types of standard or information: monographs and general chapters. A monograph is a document that explains the expectations for a food, drug, or material to ensure its identity, purity, strength, and performance. Monographs contain the chemical information for the ingredient or material and outline the tests and procedures that must occur to meet quality criteria and limit impurities. There are more than 4500 monographs for prescription drugs, over-the-counter drugs, dietary supplements, medical devices, and other products found in the 

 is a document that provides information on accepted processes, tests, and methods to support industry in product development and manufacturing quality controls. General chapters must be referenced in a specific monograph to be enforceable on a legal basis. Otherwise, general chapters contain the best practices and methods for common processes or groups of analytical targets.

 were always considered authoritative they were not officially or legally recognized in the US until a series of legislative acts: 1848 Drug Importation Act, the 1906 passage of the Food and Drug Act, and the 1938 Food, Drug and Cosmetic Act. The final act decreed that all medicines sold in the US must meet USP quality standards in what is now known as the 

USP refers to both the United States Pharmacopeial Convention and the United States Pharmacopeia. The primary document produced from the USP is the compendium called 

. The United States Pharmacopeial Convention is the organizational body enacting the workings and standards of USP. In 1888 the National Formulary (NF) was created to complement and supplement the pharmacopeia. It is a compendium of formulations and includes standards for botanicals, excipients, and other preparations not found in the pharmacopeia.  Over the decades the two compendia 

 merged in 1975 to be published under one cover called the 

The full library of the USP documents, in addition to the USP-NF, include: the 

. Additional guidance materials are frequently published and disseminated by USP to cover emerging topics. These documents are publications such as general notices, articles, white papers, and informational guides.

More than 150 countries around the world recognize and use the standards published by USP. Despite its legal recognition by US agencies, the USP is an independent organization. The USP is an “organization of organizations” with its own governance and membership and broad stakeholder engagement that direct and inform their activities and produce guidance documents for food, pharmaceutical, and dietary supplement and herbal medicine industries which include botanicals.

The USP began in the early 19th century with the idea of standardizing substances and materials used medicinally in that time, which of course meant medicines based mostly upon natural botanical, biological, and mineral ingredients. It was recognized very early in history that agricultural and botanical products are prone to adulteration or substitution. In particular, it was believed that the US was often the recipient from world suppliers of low quality or counterfeited medicinal products which had little to no efficacy. Some botanicals were often adulterated or replaced for economic gain while other materials were unintentionally or intentionally misidentified or substituted (practices which still persist to modern times).

The Drug Importation Act (1848) was enacted to control the adulterated medicinal products entering the US. Later acts, as mentioned previously, continued to attempt to control the import, sale, and use of fraudulent and adulterated medicines. It became essential that standards and testing processes be implemented to confirm identity, potency, and safety of medications. Test procedures and physical reference materials developed over the history of USP became important benchmarks and industry standards for identity and quality of botanical products and dietary supplements in addition to the pharmaceutical products. 

As the botanical and dietary supplement industry changes and grows, additional methods, procedures, chapters, and monographs are added to the information provided by USP. In the last decade, one of the “newest” markets has been cannabis. But, as we have said previously, cannabis is neither a new product to the world or USP. During the 90 years that cannabis was documented in the USP, it appeared in many forms and iterations.

The first entry in 1850 was titled: “Extractum Cannabis. Extract of Hemp.” This form was an alcohol based extract of “Cannabis sativa – variety Indica” composed of the dried tops of the plants. USP V (1870) separated cannabis species into the flowering tops of C. sativa grown in North America and the flowering tops of 

 from India. Cannabis extracts remained in the USP up until USP XII (1940) when it was criminalized by the 1937 US Marijuana Tax Act (Figure 4). 

Now, in the US on the state level, cannabis has returned for medicinal use for more than 30 states, districts, and territories with more being added each year despite the continued federal status as a Drug Enforcement Administration (DEA) schedule I substance. The individual states have each applied their own differing approaches to the regulation of cannabis. Safety of the products is a goal, but one with lack of guidance from the usual governmental sources. Standards organizations, such as USP, have started to work to include cannabis into a dietary supplements and botanical guidance framework.

Since the reemergence of cannabis as a “medicinal” product, the goal for the USP is to help ensure the quality of cannabis intended for medical purposes and the development of quality parameters for authentication and identification. These will have to include: laboratory verification of cannabis identity; quantitative analysis of cannabinoids and terpenes; and limit exposure from contaminants such as mycotoxins, pesticides, and heavy metals.

The USP organized a multistakeholder roundtable in 2016 to discuss the path forward and subsequently formed a Cannabis Expert Panel to evaluate the specifications needed to define cannabis quality attributes and characteristics. Given the complex legal and regulatory landscape, it was decided early on not to focus on publication in an official compendium, but to ensure that scientific underpinnings of cannabis quality were disseminated as quickly as possible in a broadly accessible format. One of the first goals of the panel was the characterization and definition of a heterogeneous group of species and strains generally recognized as 

. Many scientists believe that the separation or designation of two species is not accurate in expressing the variation of chemotypes and characteristics found in the currently studied cannabis species and strains (3).

The panel published it’s recommendations in a peer-reviewed journal (5) and suggested that cannabis should be viewed as a single plant species, 

, with different strains (varieties) or subtypes differentiated based on chemotype profiles. The profiles divide cannabis into three main chemotypes based on amounts of THC and cannabidiol (CBD) with the groups being classified as THC dominant, CBD dominant, or intermediate with both THC and CBD (3,4).

The first step in proper description and control of quality is to establish a standardized nomenclature and identifying characteristics, then establish quantifiable concentrations or limits. Ideally, standardization of medical cannabis would be derived from plants of similar or identical characteristics and chemotypes. Over the centuries and with the advent of agriculture and selective cultivation and breeding, cannabis plants have evolved to produce variations of cannabinoid profiles which USP has suggested be placed into one of the three chemotype groups discussed. 

The use of scientific analytical procedures is employed to identify and quantify the chemical marker compounds such as THC, CBD, and other cannabinoids or terpenes. Chromatographic methods such as high performance thin-layer chromatography (HPTLC), high performance liquid chromatography (HPLC), and gas chromatography (GC) are the most frequent tools for the separation, identification, and quantification of the cannabis marker compounds. Reference materials or physical standards, such as the ones currently produced by USP, can be used to confirm the identity of various cannabinoids by chromatographic techniques.

For these chromatographic methods, the USP has general chapters addressing the use of these techniques: 

 “High-Performance Thin-Layer Chromatography Procedure for Identification of Articles of Botanical Origin;” 

 “Identification of Articles of Botanical Origin by High-Performance Thin-Layer Chromatography Procedure;” and 

 “Articles of Botanical Origin” (see Table I). 

Chromatography methods are also applicable in the determination of terpene compounds and ratios, which can be used in the identification of cannabis varieties (4). The USP Cannabis panel is suggesting analysis of the five most prevalent terpenes found in cannabis (one sesquiterpene:  Î²-caryophyllene and four monoterpenes: D-limonene, Î²-myrcene, Î±-pinene, and Î³-terpinolene) can provide valuable identity information. Each of these terpenes has appeared as the dominant or codominant terpene in various varieties of cannabis, which could aid in confirmation of identity.

The ultimate goals for USP standards are to establish guidelines that ensure safety and create analytical limits for each type of possible contamination:  pesticides, heavy metals, aflatoxins, and so on. General chapters give instruction on all aspects of testing and manufacturing quality control practices. These chapters are guidelines for the methodology, limits, and practices for pharmaceuticals, supplements, and botanicals to ensure safety of products.

There have been multiple recalls of cannabis products over the past few years because of contamination issues. Cannabis products are subject to all the same types of contamination found in other botanical and dietary supplement products: pesticides, heavy metals, aflatoxins, microorganisms, and so on. Pesticides are an often cited reason for cannabis product recall due to exceeding state limits or presence of restricted pesticides.

Cannabis plants are highly susceptible to infestations of a variety of pests including several molds, insects, and vertebrates (5). In the past and with the absence of legal guidance, cannabis growers used an assortment of pesticides, many not intended for use with food and medicinal crops. More recently, some cannabis product recalls have been cited for using unauthorized or banned pesticides not listed for cannabis use.

Typically, in the US, pesticides are regulated by the Environmental Protection Agency (EPA), but the restricted federal status of cannabis limits their involvement in cannabis pesticide applications. In this background, the USP presents guidance in the form of general chapters intended for botanical products. 

 “Articles of Botanical Origin” establishes pesticide limits based on acceptable daily exposure, body weight, amount consumed, and a safety margin for oral exposure that can be used as a starting point for further development of pesticide residue standards for inhaled cannabis materials.

Toxic elements and heavy metals are another source of contamination in dietary supplements and botanical products. Cannabis is an effective concentrator of heavy metals. Impurities from environmental and other sources accumulate in the plant and then pose health risks for patients and consumers. For elemental impurities, USP has several chapters pertaining to heavy metal limits and testing, including limits for both dietary supplements 

Other chapters include standards for monitoring microorganisms and aflatoxins, which can be used to create limits and methodologies for cannabis testing around the world.

It has often been discussed and written that cannabis, especially at the start of the resurgence, was like the wild west with few rules and no guidance. The truth is that cannabis is a botanical product, like many other products, with a few unique challenges. Cannabis is neither a new botanical nor a totally unique one. The work of the USP over the past 200 years proves that fact. The analytical test methodologies, limits, and best practice guidance are being established by several standards organizations (USP, AOAC, ASTM, and others). These organizations often work in conjunction with each other, industry, and government to provide guidelines and standards to ensure the key components of identity, purity, and safety are met around the world for a wide range of products. Cannabis is only the latest product in need of guidance. USP has once again restarted the process to guide the cannabis industry into compliance as it has done in the past and will continue to do in the future. Additional work to research quality parameters for cannabis and derived products is currently ongoing at USP.

For more information on any of the USP chapters listed, or to volunteer to be involved in the workings of the USP process, please visit the USP website: 

www.usp.org/dietary-supplements-herbal-medicines/cannabis

USP–NF | USP-NF. Accessed May 19, 2020. 

J. Brinckmann, R. Marles, P. Schiff, H.Oketch-Rabah, G. Tirumalai, and N. Sarma, n.d. “Quality Standards for Botanicals - The Legacy of USP’s 200 Years of Contributions,” 44. 

http://abc.herbalgram.org/site/DocServer/HG126-USP-FEAT-5-1-20.pdf

“Cannabis for Medical Use: Consistent Quality to Help Protect Patients,” 

https://go.usp.org/USP-Cannabis-QualityDrivers

N.D. Sarma, A. Waye, and M.A. ElSohly, et al., 

(4),1334–1351, doi:10.1021/acs.jnatprod.9b01200 (2020).	

https://www.usp.org/sites/default/files/usp/document/our-work/DS/glossary-of-usp-terms.pdf

https://www.usp.org/sites/default/files/usp/document/about/governance/governance-members-volunteer-leadership-bodies.pdf	

 “Marijuana Timeline | Busted - America’s War On Marijuana,” Accessed May 14, 2020. 

https://www.pbs.org/wgbh/pages/frontline/shows/dope/etc/cron.html

Origins: Current Events in Historical Perspective

 “The Illegalization of Marijuana: A Brief History,” Accessed May 14, 2020. 

http://origins.osu.edu/article/illegalization-marijuana-brief-history/page/0/0

 is a Senior Applications Scientist with SPEX CertiPrep and a member of both the AOAC and ASTM committees for cannabis.

Here we examine the history of cannabis in the US, the role the USP played in that field, and the new role the USP is taking with cannabis for medical use.

Everything Old is New Again: Cannabis Returns to USP

is the President and Founder, jCanna, Inc. and Cannabis Science Conference. He is also a contributing editor for Cannabis Science & Technology.

A tribute piece to Charlotte Figi, an American girl with Dravet syndrome who took cannabidiol (CBD) oil to prevent seizures and inspired the name of the medical cannabis strain called Charlotte’s Web.

Cannabidiol (CBD), is now available everywhere-from grocery stores to gas stations. Millions of people around the globe use CBD to combat a variety of illnesses, disorders, and diseases. Yet many CBD users do not know that the awareness of the medical benefits of CBD, as well as their access to it, was due in large part to the heroic battles of a young, courageous girl named Charlotte Figi.

The cannabis industry has had many pioneers and trailblazers. We recently lost one of our greatest: Charlotte Figi, the young woman who became a hero in the CBD movement. On April 7, 2020 Charlotte passed away at the age of 13. Nichole Montanez, a close family friend of the Figi’s, posted a message on Paige Figi’s (Charlotte’s mother) Facebook page that read (1): “Charlotte is no longer suffering. She is seizure-free forever. Thank you so much for all of your love.”

We herein honor Charlotte and not only share her amazing story, but also explain the incredible inspiration that Charlotte has been to so many pediatric cannabis families.

Charlotte and her twin sister, Chase, were born on October 18, 2006 to parents Paige and Matt and big brother Max. Charlotte suffered from Dravet syndrome. According to the Dravet Syndrome Foundation (2), Dravet syndrome is a rare catastrophic, lifelong form of epilepsy that begins in the first year of life with frequent or prolonged seizures. There are currently very limited options to treat Dravet syndrome. At the tender age of 5, Charlotte suffered up to 300 grand mal seizures a week and had extreme difficulty speaking.

Paige first searched for CBD oil in 2012 and Charlotte began taking high-CBD/low-tetrahydrocannabinol (THC) oil from the cannabis strain called “Hippie’s Disappointment.” This oil immediately reduced her epileptic seizures and the oil was later named “Charlotte’s Web” in her namesake. Her story was the focus of the CNN documentary 

 hosted by Sanjay Gupta in 2013 (3), bringing worldwide attention to the medicinal benefits of CBD, and making Charlotte a key figure in the medical cannabis movement.

Sanjay Gupta, in a statement shortly after Charlotte’s passing said (4), “Charlotte changed the world. She certainly changed my world and my mind. She opened my eyes to the possibility of cannabis being a legitimate medicine. She showed me that it worked to stop her crippling seizures, and that it was the only thing that worked.”

The Stanley brothers, who bred and commercialized Charlotte’s Web, the high-CBD/low-THC cannabis strain named after Charlotte, paid tribute to her on their website (5), stating: “Charlotte was ten feet tall and carried the world on her shoulders. Inspiring is a lacking word, as are courageous and vivacious and strong and beautiful. She was divine. She grew, cultivated by a community, protected by love, demanding that the world witness her suffering so that they might find a solution. [...] Her story built communities, her need built hope, and her legacy will continue to build harmony.”

Charlotte inspired the medical cannabis revolution by championing the life-changing effects of CBD for patients with seizures and other debilitating illnesses and influenced legislation reform across the United States and worldwide. Congressman Matt Gaetz (R-FL) one of the leading GOP champions for broad marijuana reform on Capitol Hill, provided this statement on Twitter (6): “Charlotte lived a life of tremendous significance. Her story inspired me to completely change my views on medical cannabis and successfully pass legislation so that patients could get help in Florida.”
	In addition to championing that CBD bill in Florida, a bipartisan congressional bill, “The Charlotte’s Web Medical Access Act” was named after her and introduced in 2015 (7).

For this special edition of “Cannabis Crossroads,” I want to honor Charlotte not by reciting the legislation that she impacted, but by taking a closer look at the amazing influence and inspiration that she provided to so many pediatric cannabis families. These families became pediatric cannabis trailblazers themselves, forging ahead from inspiration drawn from Charlotte. (See upper right for FIgure 1, click to enlarge.)

Gail Rand, whose son Logan was diagnosed with epilepsy at age one and ADHD at age two, spoke about how she first heard about Charlotte in June 2012 and her life was forever changed. “Her family’s willingness to share their story in a time where the stigma around medical cannabis was huge and the Federal government was still raiding many facilities was so incredibly brave,” said Rand. “Her mom, Paige, shared Charlotte’s story with Maryland legislators and regulators in a way that was incredibly powerful. They got to ask questions and learn that this is real medicine that could have a massive impact on Marylanders. For me, it is personal-my son is seizure free and his life was saved because of Charlotte. I know she is a daughter, sister, and friend, but to millions of people she is an icon of change and I’m forever grateful.”

I also spoke with Tracy Ryan, founder of CannaKids and Saving Sophie. Tracy’s daughter Sophie was diagnosed with an optic pathway glioma brain tumor at eight months old. Ryan explained that it was the documentary, 

, that not only changed the course of medical cannabis forever, but also gave family’s like hers legitimacy in their choice to use this plant on their small children. “It quelled judgement and paved a way that only a story like Charlotte’s could do. When Sophie was honored with being one of the first 20 children in California to receive Charlotte’s Web oil over 6 years ago, we forever felt connected to this family that we owe so much to,” said Ryan. “Our entire industry, worldwide, has this little girl’s struggles to thank for advancements in the understanding of this plant that could otherwise have taken a decade. God gave Charlotte a very important mission to fulfill, and she not only did so, but saved countless lives globally and forever changed the world leaving it a healthier and happier place than when she entered it.”

I also spoke with mother and daughter powerhouses, Janie and Rylie Maedler, about how Charlotte influenced them. Janie’s daughter Rylie was diagnosed with an extremely rare, aggressive giant cell granuloma in 2013. “Charlotte Figi was and still is an inspiration to me,” said Rylie Maedler. “Charlotte was living proof that cannabis can help treat those with severe untreatable epilepsy. She helped introduce cannabis as a treatment for pediatrics. Although Charlotte may not physically be with us now; what she accomplished will always be with us.”

“I know speaking as a mom that in your gut, you know what has to be done to save your child and this does away with fear,” said Janie Maedler. “Paige and Charlotte have given parents the strength they have needed to follow that gut. I’m forever thankful to them for this.”

Finally, I spoke to Moriah Barnhart whose daughter, Dahlia, was diagnosed with aggressive brain cancer at the age of two. “Sharing your child’s story in order to change public perception can come with stifling political, social, and psychological repercussions,” said Barnhart. “To embrace those repercussions while dealing with the daily struggles of caring for a severely special needs child takes unimaginable bravery and resilience. The life and death of Charlotte Figi embody the idea that suffering should not be in vain.”

In closing, I would like to share my deepest appreciation and gratitude to Charlotte and her family for advocating for their daughter’s healthcare and access to medicinal cannabis as a treatment, not only for their family, but for families all around the world. Charlotte has had a massive impact on the global cannabis community that will never be forgotten. The Figi’s are true pioneers that have opened so many minds about cannabis treatments with their advocacy and story sharing. Colorado Governor Jared Polis proclaimed April 7th, “Charlotte Figi Day” in Colorado. The loss of Charlotte Figi was felt around the world and she will be greatly missed by our entire community, but her legacy will live on forever and will continue to inspire many more individuals for years to come.

https://www.cnn.com/2013/08/08/health/gupta-changed-mind-marijuana/index.htmlhttps://www.facebook.com/paige.figi/posts/10157904490519765

https://www.dravetfoundation.org/what-is-dravet-syndrome/

https://www.cnn.com/2013/08/08/health/gupta-changed-mind-marijuana/index.html

https://www.cnn.com/2020/04/08/health/sanjay-gupta-weed-charlotte-figi-tribute/index.html

A tribute piece to Charlotte Figi, a medical cannabis and CBD pioneer who inspired the name of the medical cannabis strain Charlotte’s Web.

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