Tag Archives: quality

Digipath Expands To California

By Aaron G. Biros
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In July, we sat down with the folks at Digipath, Inc. when they received their testing license in Nevada for the adult use market. In that conversation, they mentioned they were looking to expand into California.

According to a press release published September 25th, DigiPath, Inc. has entered a joint venture to establish their first cannabis-testing lab in California. They will be working with Don Ashley, an experienced real estate developer and cannabis entrepreneur, to launch Humboldt Botanical, LLC, conducting business under the name “Digipath Botanical Testing”.

Ashley says they expect to be fully operational by Q1 of 2018. “We expect to break ground on this project in the next few weeks and hope to be operational in early Q1 2018 just after the state-wide adult-use market is expected to launch, as we have already obtained approval from the local planning authorities for the entire complex,” says Ashley.

Todd Denkin, founder and president of Digipath

Todd Denkin, president of Digipath, is optimistic for California’s market and the coming regulations. “The state of California is estimated to be the single largest cannabis market in the U.S. Adult-use cannabis legislation was approved by California residents last November, and we expect these new regulations to be implemented in 2018,” says Denkin. “The good news for the industry is that the requirements for cannabis testing will be significant, and we are excited to partner with Don and his team to pursue this opportunity in Humboldt County.”

Ashley is contributing roughly $2 million to build and equip the lab with instrumentation, while Digipath Labs will manage and supervise operations at the lab. According to the press release, Digipath will provide a non-exclusive license to use its intellectual property for the operation of the lab. Digipath Labs will retain rights over all the scientific data generated in the lab.

Cindy Orser, PhD., chief science officer at Digipath

According to Cindy Orser, PhD., chief science officer at Digipath, that data will be put to good use. “Digipath Labs has developed an algorithm for use in strain authentication based largely on terpene profiling from our testing lab in Nevada and we are eager to further test our hypothesis with an expanded dataset from cannabis grown in Northern California,” says Orser.

While testing labs are primarily seen as safeguards for public health and safety, using data to correctly identify strains is a relatively new concept. “Digipath Labs is all about public health and safety through testing for adulterants,” says Orser. “Another component to quality is having confidence in product authenticity at the dispensary level. Not only is the consumer buying quality assured products but truth in advertising when it comes to strain nomenclature.”

Denkin says they were proactive in working toward getting the license early on. “Our partners have been dealing with the local regulators while we have been providing the proper SOP’s for the local government in order to receive the proper licensure in the area,” says Denkin. Taking their experience from Nevada to California, Orser says they have been asked to present to the California Toxicology Association on their experience with cannabis testing in the highly regulated marketplace of Nevada.

The laboratory in Humboldt is going to be part of a “cannabis industrial park,” alongside an R&D facility, oils/concentrate manufacturing center, health and wellness center, distribution and processing facility, tissue culture nursery, hemp clothing outlet, and coffee bistro, according to the press release.

Looking forward to growing their business, Denkin says they hope to launch a lab in Southern California. “We do expect to have a larger footprint in California because of the size of the market and are looking for locations in Southern California as well,” says Denkin. When asked about any new plans to expand elsewhere, Denkin says they’ll let us know. “We are continuing with our business plan and actively seeking the right mergers and acquisitions. Stay tuned.”

EVIO Logo

EVIO Labs Expands To Florida

By Aaron G. Biros
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EVIO Logo

Currently, there are no lab testing regulations for Florida’s medical cannabis market. Chris Martinez, co-founder and chief operating officer of EVIO Labs Florida, a veteran-owned business, is looking to change that.

Chris Martinez, co-founder and president of EVIO Labs Florida

When Martinez co-founded EVIO Labs Florida, he saw the need for a dedicated cannabis lab to ensure safety and quality of medicine for patients in the state. Partnering with EVIO Labs to accomplish this goal, Martinez secured a 5,500 sq. ft. facility in Broward County to test for potency, pesticides, microbial contaminants, terpenes, residual solvents and heavy metals. Their lab, a first of its kind in the industry, qualifies as a true pharmaceutical-grade clean room. This week, Martinez also secured their 2nd laboratory location in the City of Gainsville, where they will test for potency, microbials, terpenes and residual solvents. And he isn’t doing it on the cheap. “Our Broward lab is powered by Shimadzu with over $1.2M in the latest testing equipment utilizing LCMS technology with the world’s fastest polarity switching time of 5 m/sec and scan speeds of 30,000 u/sec with UF Qarray sensitivity 90 times that of previously available technologies,” says Martinez.

Martinez, an entrepreneur at heart, started the lab with a team of experts to become the first completely cannabis-focused laboratory in Florida. Jorge Segredo, their head chemist and quality assurance director, has over 18 years of experience in the development of nutraceutical and pharmaceutical products under ISO and FDA accreditation. Segredo has helped launch three independent FDA-accredited laboratories and has extensive knowledge of HPLC, GCMS, LCMS, ICPMS technologies and development/validation of testing methods and procedures. Cynthia Brewer, their director of operations, was an active participant in the 2017 state legislative session and has been an advocate for medical cannabis, working with legislators on a suitable framework to increase patient access to cannabis.

The EVIO team is using instruments from Shimadzu

EVIO is one of the nation’s leaders in cannabis testing, research science and advisory services. It is an evolving network of laboratories with nine EVIO cannabis laboratories operating in five different states: Oregon, Colorado, Massachusetts, Florida and California. “After speaking with industry chemists around the country for months, the EVIO name was constantly brought up in conversation,” says Martinez. “When we spoke with the EVIO Team it was an easy decision for us to partner.” He says Lori Glauser, chief operating officer of EVIO, and William Waldrop, chief executive officer of EVIO, are truly visionaries in the cannabis industry.

According to Martinez, their licensing agreement with EVIO Labs (OTC:SGBYD) marked a first for the publicly traded company with exclusivity in the Florida market. The agreement includes proprietary testing methodologies, operating procedures, training and support.

In addition to testing cannabis for safety and quality, they are launching a technology platform called MJ Buddy, essentially a software tool that takes efficacy feedback from patients and uses testing and genetic data they gather from EVIO Labs across the country. “This will provide real data to the cannabis industry as to the medical benefits for thousands of patients in relation to the genotype and cannabinoid profiles of their medicine,” says Martinez.

Of the states that have legalized some form of cannabis, a large number of them have some lab testing regulations on the book, with some more comprehensive than others. Martinez says he hopes the Florida Department of Health, Office of Medical Marijuana Use follows some of the more thorough state programs, such as Oregon. His team has compiled a set of documents for regulators with recommendations for regulating the lab testing industry.

Without any regulations on paper, it is up to businesses to produce safe and quality medicine, without any oversight. EVIO Labs Florida follows FDA Good Laboratory Practices, has an ISO 17025:2005 accreditation pending, and is working on TNI 2016 accreditation.

When discussing what he wants to see happen with Florida’s regulatory framework, Martinez says the rules need to be specific to Florida. For example, due to the climate being so humid, microbial contaminant testing for things like yeast and mold will be particularly imperative. Because processing methods like butane and alcohol extraction are legal, he emphasizes the need for comprehensive residual solvents testing. “The most important regulation would be to have the laboratories select the samples at the MMTC facility and have the state randomly verify laboratory results to ensure accurate unbiased testing,” says Martinez.

In addition to that, he hopes their pesticide thresholds will be realistic and based on actual science. “We believe the public should receive carcinogenic data for products that are inhaled,” says Martinez. “Chemicals may be introduced into the processing of cannabis to vape liquid that may cause harm. This is important information for public health and communication of the risk related to exposure to such materials.” Martinez says EVIO Labs Florida was founded on the belief that through technology and science we can increase safety and patient outcomes.

New Colorado Edibles Regulations Effective October 1st

By Aaron G. Biros
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Back in April of 2016, the Colorado Legislature passed HB 1436 in an effort to make infused products less appealing to children. On October 1st, 2017, the new law goes into effect, which will prohibit the sale of edibles in the shape of a human, animal or fruit.

The THC universal symbol

Colorado has a history of regulating the market like this, with laws designed to limit the dosing, consistency and appeal of edibles to children. In 2015, regulators placed a 100-milligram cap on THC in infused products, separated into 10-milligram servings. In 2016, regulators began requiring the THC stamp on edibles, a symbol with a clear representation of what the product contains.

Some in the industry are welcoming of these new laws, while others think it might be overregulation. Regardless, manufacturers that have previously produced things like fruit candies or gummy bears now need to update their processes to use non-descript shapes for their products in order to stay compliant.

incredibles logoBob Eschino, founder and president of Incredibles, an infused product manufacturer in Colorado, says these rules are not very effective at preventing kids from obtaining edibles, but it could help. “I believe consumer protection comes from CRP [child-resistant packaging], proper labeling, education and safe storage,” says Eschino. “CDPHE said themselves that stamping or shaping the products is the least effective way to prevent accidental ingestion. It’s a step that will add to consumer protection in a small way, but every little bit helps for now.” There are a number of more effective measures that regulators in Colorado take to prevent edibles from getting in the hands of children, such as child-resistant packaging, prohibiting advertising of cartoon characters, requiring opaque packaging and warning messages on labels.

Products like infused gummy bears will no longer be permitted for retail; Photo: Tamara S., Flickr

According to Peggy Moore, partner of Love’s Oven, an infused product manufacturer, and board president of the Cannabis Business Alliance, the major change companies need to make to stay compliant is ordering new molds. “Depending on the quantity ordered, molds can cost $10,000 or more to fabricate and produce.,” says Moore. “If a company was not using molds previously there is also training that may be required to orient production staff on technique for making molded confections.” She says there are still plenty of options for manufacturers to use like botanical shapes (a cannabis leaf, for example), circles, squares, rectangles and other shapes.

Her company, Love’s Oven, makes caramels, baked goods, crackers and other non-descript shapes already. “At this point I am not aware of any manufacturers who are not already compliant with this rule in advance,” says Moore. “The most common solution is to move to a square, circle or other shape utilizing molds. “ Moore believes it is a producer’s duty to make products that are not enticing to children. “Regardless of the industry (alcohol, cannabis, pharma) I think we should exercise great caution to not produce products that are targeting children,” says Moore. “While I would love to see manufacturers self-regulate in this regard, clearly some guardrail regulations are needed at this point.”

In addition to the rule on using non-descript shapes, HB 1436 prohibits the use of additives in retail cannabis products that are designed to make it addictive, more appealing to children or misleading consumers. The rule does, however, exclude common baking and cooking ingredients. There is also a stipulation that permits local fire departments to perform annual fire inspections at cannabis cultivation facilities.

emerald test retail

Colorado Approves Emerald Scientific Proficiency Tests for Regulatory Compliance in Cannabis Testing

By Aaron G. Biros
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emerald test retail

Emerald Scientific recently announced their proficiency-testing program, The Emerald Test, has been approved by Colorado as a third party provider for proficiency testing in licensed cannabis laboratories. The Emerald Test, held twice annually, is an inter-laboratory comparison and proficiency test (ILC-PT), allowing data to be collected pertaining to the performance of laboratories on a national scale. Proficiency testing is designed to measure how accurately laboratories perform and is a critical tool for quality assurance.

Colorado requires labs to participate in a proficiency-testing program in order to be certified to conduct required testing on cannabis and cannabis products for safety and quality. According to the press release, Colorado’s Marijuana Enforcement Division, under the Department of Revenue, conducted an evaluation process to determine which applicants could meet the performance standards for regulatory compliance concerning proficiency testing. The contract was awarded to Emerald Scientific following this evaluation process.

emerald test retailAccording to Ken Groggel, director of the Proficiency Testing Program at Emerald Scientific, a number of states have recognized the need for independent proficiency testing as a required piece of regulatory compliance. “The Emerald Test Inter-Laboratory Comparison/PT is state approved in Washington & Colorado for cannabis testing laboratory licensure,” says Groggel. “States with cannabis or hemp production, as well as labs in other countries are now actively participating in the Emerald Test as a tool for quality improvement, efficiency upgrades and product safety.” He says the Colorado Marijuana Enforcement Division has contracted with Emerald Scientific to provide third party PT programs for microbial contaminants, residual solvents and pesticides.

Ken Groggel, director of the Proficiency Testing Program at Emerald Scientific

Beginning in 2014, The Emerald Test has been offered twice a year and, in 2017, over 50 labs participated from 14 states and 2 countries. “Laboratories that have enrolled more than once have seen significant improvement in their results, an indicator of improved performance for industry customers,” says Groggel.

Proficiency testing is important for ensuring quality, safety and product content accuracy. “This should be the priority whether you are a grower, manufacturer, testing laboratory, regulatory entity, medical patient or adult use consumer,” says Groggel. It also helps labs meet regulatory requirements and achieve ISO 17025 accreditation. “Independent proficiency testing helps determine if the lab is able to deliver the services marketed to its customers,” says Groggel. “Regulatory agencies can use this information when licensing, monitoring & enforcing good science for public safety.”

As new states legalize cannabis and develop consumer protection regulations, proficiency testing programs can help labs demonstrate their commitment to responsible and accurate testing. “When PT results show the cannabis testing lab is capable it is up to the government to ensure accountability for performance on behalf of all its citizens,” says Groggel. Labs can enroll starting on September 25th in the Fall 2017 Emerald Test ILC/PT.

Massachusetts Recreational Consumer Council Launches Education Program

By Aaron G. Biros
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The Massachusetts Recreational Consumer Council (MRCC) is an interesting nonprofit that recently launched an educational campaign, called Consume Responsibly Massachusetts. For many cannabis advocates who watched their states legalize the drug, consumer education is a very important part of moving forward. As states across the East Coast implement regulatory frameworks for the cannabis industry, there is a sense of urgency to make sure the rules are right the first time, and that cannabis businesses become responsible stewards of their new market.

In the wake of pesticide recalls in the west and related public health concerns, the issues surrounding consumer safety and how states protect that are now front and center. “The purpose of Consume Responsibly Massachusetts is to keep adult-consumers informed of their rights in the state,” says Jefferson. “It’s also an ongoing effort to bring consumers into the world of cannabis politics and science.”

The MRCC’s mission is to help protect the safety of recreational cannabis consumers by bridging the information gap between businesses, legislators and communities. “We work at the state and local level advocating for sensible recreational marijuana policy and regulations,” reads a press release. According to Kamani Jefferson, president of the MRCC, bridging that gap requires a lot of community engagement. “I was a field organizer on the Campaign to Tax and Regulate Marijuana here in Massachusetts so this is extremely important to me,” says Jefferson. “MRCC participated in this year’s Cambridge 5K Freedom Run.” He says getting out in the community like this is one of many ways to help provide educational opportunities, help promote local cannabis businesses and get rid of the “lazy stoner stigma.”

Kamani Jefferson, president of the MRCC

For the MRCC, the issue of craft cannabis is a significant part of the organization’s philosophy, in addition to product safety and others. “Craft Cannabis will benefit the consumer in an entirely new way,” says Jefferson. “Members of the community will have a chance to provide products and directly affect the economy.” Because local owners tend to be more involved in their towns, Jefferson says residents will get to make more of an impact than nonlocal owners. And he’s right- small, local businesses contribute substantially more to local economies and communities than large companies. Between 1993 and 2013, small businesses created roughly 63% of all new jobs in the United States. With the new cannabis market comes a promising opportunity for local economies.

“The Massachusetts cannabis industry is developing and growing fast,” says Jefferson. “Aside from the medical marijuana production sites, the new recreational marijuana law grants production participation in the regulated recreational marijuana industry to farmers, in the form of craft marijuana cultivator cooperative systems.” While he thinks this is a good opportunity for small businesses and communities alike to gain a foothold in the market, Jefferson is hesitant to endorse Massachusetts’ regulatory policies. “A lack of regulatory oversight from the CCC [Cannabis Control Commission] places the cannabis industry in a vulnerable position,” says Jefferson. “If we want clear, consistent standards for clean and safe products prioritized, then we need consistent testing data.” Jefferson is arguing for more regulatory oversight for safety issues, such as contaminant testing. This is one of a handful of issues they are pressing for sensible cannabis policy in Massachusetts.

Here are some of the issues they support:

  • Local Cannabis: Equitable licensing for small and medium sized local businesses from members of the community.
  • Quality Control: Access to a variety of clean and safe cannabis products in retail dispensaries, tested for harmful contaminants, mold, pesticides and fungicides.
  • Responsible + Safe Consumption: Access to educational materials about proper dosage, methods of ingestion, quality analysis, understanding product labels and general cannabis information.
  • High Potency Flowers, Edibles, & Concentrates: Access, non-restriction to high potency marijuana products of all forms.
  • Home Grow: Ability to grow at least 6 plants per person, 12 per household as stated in Question 4.
  • Social Use: The ability to consume in designated establishments outside of the household.
  • Expungement: Sentence commutation and record expungement for convictions involving non-violent marijuana charges that are now legal.
  • Research: University supported biological, behavioral and cognitive marijuana research to further our understanding and capabilities of the cannabis plant.
Soapbox

Clear vs. Pure: How Fallacies and Ignorance of Extraction Misrepresent the Cannabis Flower

By Dr. Markus Roggen
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Demand for cannabis extracts, in particular vaping products, is at an all-time high. People want good oil, and they want to know something about the quality of it. It is therefore time to take a step back and consider the process from plant to cartridge. What is the current industry standard for cannabis extraction, what constitutes quality and where might we need to make some adjustments?

Right now, “clear” oil is hot. Customers have been led to believe that a pale gold extract is synonymous with the best possible cannabis concentrate, which is not necessarily the case. Producing a 95% pure THC extract with a translucent appearance is neither a great scientific feat nor a good representation of the whole cannabis flower. Moreover, it runs counter to the current trend of all-natural, non-processed foods and wellness products.

“My carrots are organic and fresh from the farmers market, my drink has no artificial sweeteners and my honey is raw, but my cannabis oil has undergone a dozen steps to look clear and still contains butane.”Cannabis is a fascinating plant. It is the basis of our livelihood, but more importantly, it enhances the quality of life for patients. The cannabis plant offers a plethora of medicinally interesting compounds. THC, CBD and terpenes are the most popular, but there are so many more. As of the most recent count, there are 146 known cannabinoids1. Cannabinoids are a group of structurally similar molecules2, including THC and CBD, many of which have shown biological activity3.

Then there are terpenes. These are the smaller molecules that give cannabis its distinct smell and flavor, over 200 of which have been identified in cannabis4. But wait, there’s more. The cannabis plant also produces countless other metabolites: flavonoids, alkaloids, phenols and amides5. All these components mixed together give the often-cited entourage effect6,7.

Current industry standards for cannabis oil extraction and purification stand in marked contrast to the complexity of the plant’s components. Due to an unsophisticated understanding of the extraction process and its underlying chemistry, cannabis oil manufacturers frequently produce oil of low quality with high levels of contamination. This necessitates further purifications and clean up steps that remove such contaminants unfortunately along with beneficial minor plant compounds. If one purifies an extract to a clear THC oil, one cannot also offer the full spectrum of cannabinoids, terpenes and other components. Additionally, claiming purities around 95% THC and being proud of it, makes any self-respecting organic chemist cringe8.

Precise control of extraction conditions leads to variable, customized concentrates. THC-A crumble, terpene-rich vape oil, THC sap (from left to right).

The labor-intensive, multi-step extraction process is also contrary to “the clean-label food trend”, which “has gone fully mainstream”9. Exposing the cannabis flower and oil to at least half a dozen processing steps violates consumer’s desire for clean medicine. Furthermore, the current practice of calling supercritical-CO2-extracted oils solvent-less violates basic scientific principles. Firstly, CO2 is used as a solvent, and secondly, if ethanol is used to winterize10, this would introduce another solvent to the cannabis oil.

We should reconsider our current extraction practices. We can offer cannabis extracts that are free of harmful solvents and pesticides, give a better, if not full, representation of the cannabis plant and meet the patients’ desire for clean medicine. Realizing extracts as the growth-driver they are11 will make us use better, fresher starting materials12. Understanding the underlying science and learning about the extraction processes will allow us to fine-tune the process to the point that we target extract customized cannabis concentrates13. Those, in turn, will not require additional multi-step purification processes, that destroys the basis of the entourage effect.

The cannabis industry needs to invest and educate. Better extracts are the result of knowledgeable, skilled people using precise instruments. Backroom extraction with a PVC pipe and a lighter should be horror stories of the past. And only when the patient knows how their medicine is made can they make educated choices. Through knowledge, patients will understand why quality has its price.

In short, over-processing to make clear oil violates both the plant’s complexity and consumers’ desires. Let us strive for pure extracts, not clear. Our patients deserve it.


[1] Prof. Meiri; lecture at MedCann 2017

[2] ElSohly, Slade, Life Sciences 2005, 539

[3] Whiting, et. al., JAMA. 2015, 2456

[4] Andre, Hausman, Guerriero, Frontiers in Plant Science 2016, 19

[5] Hazekamp, et. al., Chemistry of Cannabis Chapter 3.24; 2010 Elsevier Ltd.

[6] Ben-Shabat, et al.; Eur J Pharmacol. 1998, 23

[7] Mechoulam, et al.; Nat Prod Rep. 1999, 131

[8] Medical and Research Grade chemicals are generally of purities exceeding 99.9%

[9] Bomgardner, Chemical & Engineering News 2017, 20

[10] Winterization is the industry term for what is correctly referred to as precipitation.

[11] Year-over changes to market shares in Colorado 2015 to 2016: Concentrates 15% to 23%; Flower 65% to 57%, BDS Analytics, Marijuana Market Executive Report, 2017

[12] Further reading about the whole extraction process: B. Grauerholz, M. Roggen; Terpene and Testing Magazine, July/Aug. 2017

[13] Further reading about optimizing CO2 extraction: M. Roggen; Terpene and Testing Magazine, May/June 2017, 35

Florida Medical Cannabis Market Growth Stymied By Red Tape

By Aaron G. Biros
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The demand for medical cannabis in Florida might be growing steadily, with patient numbers soaring, but that doesn’t mean the market will grow accordingly. Due to hampering regulations and a lack of state guidance, the industry in Florida is tiny and patients have limited options for medical cannabis products.

A little more than three years ago, Governor Rick Scott signed a bill into law, legalizing medical cannabis, but only for terminally ill patients and only for one strain, Charlotte’s Web. That stipulated a low-THC, concentrated oil form of cannabis. That bill also set up the licensing framework for what is now an extremely limited market.

Florida Gov. Rick Scott has been accused of making the licensing process secretive Photo: Gage Skidmore, Flickr

In November of 2015, the Office of Compassionate Use, now called the Office of Medical Marijuana, issued licenses for five dispensaries. To get a license, applicants needed to meet a variety of absurd requirements. That included being a nursery in business for thirty years, growing a minimum of 400,000 plants at the time of applying, paying $300,000 in fees and a $5 million performance bond.

Fast forward to Election Day last year when voters passed Amendment 2 by a wide margin, amending the state’s constitution and legalizing medical cannabis for a broader scope of qualifying conditions. What hasn’t changed, however, is the old vertical licensing framework. Critics have dubbed this a “pay-to-play” market, with massive barriers to entry prohibiting small businesses from gaining market access.

David C. Kotler, Esq.

David Kotler, Esq., attorney and partner at CohenKotler P.A., says we shouldn’t expect to see a viable market for years as a result of all this red tape. “Honestly the State of Florida, with their limited licenses and odd requirements to qualify for licensure have stunted what could be a good market both for businesses and patients,” says Kotler. “It has been an inefficient roll-out and is truly an embarrassment for the state, legislature and the Department of Health.” Kotler says he’s heard reports of extremely limited product selection, poor quality, as well as no dried flower being offered.

But the patients are pouring in by the thousands- on July 27th, the Office of Medical Marijuana reported 26,968 registered medical patients, with more than 10,000 patients signing up since June 7th. “Despite my belief that it would be a slow roll out, it appears the patient count is picking up,” says Kotler. “The elimination of the 90-day doctor-patient relationship will certainly help this.” He is referring to the reversal of a waiting period policy, where patients had to wait 90 days before receiving a medical cannabis certification. “But there still seems to be a backup with issuance of cards and poor guidance from the Department of Health leaving many doctors unsure of what they should be doing,” says Kotler. The rules and guidelines for physicians participating in the program are still not established, but the Florida Board of Medicine expects to vote on them this week, reports say.

Matt Karnes, founder and managing partner of GreenWave Advisors

With seven licensees right now and a total of ten licensees by October allowed to grow and distribute cannabis products, the question remains if that is enough to satisfy the growing number of patients. According to Matt Karnes, founder and managing partner of GreenWave Advisors, the state is adjusting by adding more licensees and allowing them to operate more dispensaries, potentially trying to sate that demand. “Both of these amendments will likely serve as a catalyst for revenue growth but could be tempered by a lack of physician participation (as we have seen in other states) in the medical marijuana program,” says Karnes. “For every incremental 100,000 patients who register in the Medical Marijuana program, four more licenses will be issued and existing licensees will be allowed to open another four dispensaries (current cap is 25). We do not expect an incremental 100,000 patients until sometime in 2021.” His firm’s market projections account for those increases and edibles now being sold, but still no dry flower allowed. They project total sales figures in the state to reach $712 million by 2021.

Those figures are contingent on the increase in registered patients and more licensees. If Florida’s vertical licensing model remains, it’s quite possible the state will see a cannabis shortage, much like Nevada during their opening month of adult use sales. “Instead of learning from so many states before it, Florida forged a path down the rabbit hole that may limit Florida’s potential until either a legislative change or a backlash at the polls in the form of an amendment bringing forth adult use,” says Kotler. In New York, that vertical licensing model arguably created a monopoly, with only a select few businesses controlling the entire market. That doesn’t foster market growth; it hurts quality, keeps prices high and prevents real competition. “We see how that worked out for New York,” says Kotler. “We cling to that despite what could be a large patient base with the potential to service tourists who wish to have reciprocity.”

Florida’s market could be a powerhouse for the state, with the potential to generate millions in tax revenue, create thousands of jobs and actually help patients get the medicine they need. But until the state ditches their conservative, closed-door approach, we won’t see the industry truly flourish. .

extraction equipment

Implementing a HACCP Plan in Cannabis Processing

By Aaron G. Biros
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extraction equipment

Hazard analysis and critical control points (HACCP) is a robust management system that identifies and addresses any risk to safety throughout production. Originally designed for food safety through the entire supply chain, the risk assessment scheme can ensure extra steps are taken to prevent contamination.

The FDA as well as the Food Safety and Inspection Service currently require HACCP plans in a variety of food markets, including high-risk foods like poultry that are particularly susceptible to pathogenic contamination. As California and other states develop and implement regulations with rigorous safety requirements, cannabis cultivators, extractors and infused product manufacturers can look to HACCP for guidance on bolstering their quality controls. Wikipedia actually has a very helpful summary of the terms referenced and discussed here.

Dr. Markus Roggen, vice president of extraction

The HACCP system consists of six steps, the first of which being a hazard analysis. For Dr. Markus Roggen, vice president of extraction at Outco, a medical cannabis producer in Southern California, one of their hazard analyses takes place at the drying and curing stage. “When we get our flower from harvest, we have to think about the drying and curing process, where mold and bacteria can spoil our harvest,” says Dr. Roggen. “That is the hazard we have to deal with.” So for Dr. Roggen and his team, the hazard they identified is the potential for mold and bacteria growth during the drying and curing process.

The next step in the HACCP system is to identify a critical control point. “Correct drying of the flower will prevent any contamination from mold or bacteria, which is a control point identified,” says Dr. Roggen. “We also have to prevent contamination from the staff; it has to be the correct environment for the process.” That might include things like wearing gloves, protective clothing and hand washing. Once a control point is identified, the third step in the process is to develop a critical limit for those control points.

A critical limit for any given control point could be a maximum or minimum threshold before contamination is possible, reducing the hazard’s risk. “When we establish the critical limit, we know that water activity below 0.65 will prevent any mold growth so that is our critical limit, we have to reach that number,” says Dr. Roggen. The fourth step is monitoring critical control points. For food manufacturers and processors, they are required to identify how they monitor those control points in a written HACCP plan. For Dr. Roggen’s team, this means using a water activity meter. “If we establish the critical control point monitoring, water activity is taken throughout the drying process, as well as before and after the cure,” says Dr. Roggen. “As long as we get to that number quickly and stay below that number, we can control that point and prevent mold and bacteria growth.”

One of the cultivation facilities at Outco

When monitoring is established and if the critical limit is ever exceeded, there needs to be a corrective action, which is the fifth step in a HACCP plan. In Dr. Roggen’s case, that would mean they need a corrective action ready for when water activity goes above 0.65. “If we don’t have the right water activity, we just continue drying, so this example is pretty simple,” says Dr. Roggen. “Normal harvest is 7 days drying, if it is not dry enough, we take longer to prevent mold or bacteria growth.”

The sixth step is establishing procedures to ensure the whole system works. In food safety, this often means requiring process validation. “We have to double check that our procedure and protocols work,” says Dr. Roggen. “Checking for water activity is only a passive way of testing it, so we send our material to an outside testing lab to check for mold or bacteria so that if our protocols don’t work, we can catch those problems in the data and correct them.” They introduced weekly meetings where the extraction and cultivation teams get together to discuss the processes. Dr. Roggen says those meetings have been one of the most effective tools in the entire system.

Dr. Roggen’s team identified worker safety as a potential hazard

The final step in the process is to keep records. This can be as simple as keeping a written HACCP plan on hand, but should include keeping data logs and documenting procedures throughout production. For Dr. Roggen’s team, they log drying times, product weight and lab tests for every batch. Using all of those steps, Dr. Roggen and his team might continue to update their HACCP plans when they encounter a newly identified hazard. While this example is simplistic, the conceptual framework of a HACCP plan can help detect and solve much more complex problems. For another example, Dr. Roggen takes us into his extraction process.

Dr. Roggen’s team, on the extraction side of the business, uses a HACCP plan not just for preventing contamination, but for protecting worker safety as well. “We are always thinking about making the best product, but I have to look out for my team,” says Dr. Roggen. “The health risk to staff in extraction processes is absolutely a hazard.” They use carbon dioxide to extract oil, which carries a good deal of risks as well. “So when we look at our critical control points we need to regularly maintain and clean the extractor and we schedule for that,” says Dr. Roggen.

Gloves, protective clothing, eyewear and respirators are required for workers in the extraction process.

“My team needs respirators, protective clothing, eyewear and gloves to prevent contamination of material, but also to protect the worker from solvents, machine oil and CO2 in the room.” That health risk means they try and stay under legal limits set by the government, which is a critical limit of 3,000 ppm of carbon dioxide in the environment. “We monitor the CO2 levels with our instruments and that is particularly important whenever the extractor is opened.” Other than when it is being opened, Dr. Roggen, notes, the extractor stays locked, which is an important worker safety protocol.

The obvious corrective action for them is to have workers leave the room whenever carbon dioxide levels exceed that critical limit. “We just wait until the levels are back to normal and then continue operation,” says Dr. Roggen. “We updated our ventilation system, but if it still happens they leave the room.” They utilize a sort of double check here- the buddy system. “I took these rules from the chemistry lab; we always have two operators working on the machine on the same time, never anyone working alone.” That buddy check also requires they check each other for protective gear. “Just like in rock climbing or mountain biking, it is important to make sure your partner is safe.” He says they don’t keep records for employees wearing protective gear, but they do have an incident report system. “If any sort of incident takes place, we look at what happened, how could we have prevented it and what we could change,” says Dr. Roggen.

He says they have been utilizing some of these principles for a while; it just wasn’t until recently that they started thinking in terms of the HACCP conceptual framework. While some of those steps in the process seem obvious, and it is very likely that many cannabis processors already utilize them in their standard operating procedures and quality controls, utilizing the HACCP scheme can help provide structure and additional safeguards in production.

A2LA Accredits First Cannabis Testing Laboratory in Washington State

By Aaron G. Biros
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The American Association for Laboratory Accreditation (A2LA) announced today that they just accredited the Washington State Department of Agriculture-Chemical and Hop Laboratory to ISO 17025. The laboratory, based in Yakima, WA, finished the accreditation process on May 3, 2017.

The lab was accredited to ISO/IEC 17025 – General Requirements for the Competence of Testing and Calibration Laboratories, so they are now able to test for pesticides in cannabis and other matrices, according to the press release published today. “WSDA sought this accreditation to ensure our clients can have absolute confidence in our testing methods and lab results. The information we produce drives enforcement cases and policy decisions,” says Mike Firman, manager of the WSDA Chemical and Hop Laboratory. “We want to do everything that can be done to make sure our data is reliable.”

The A2LA Cannabis Accreditation Program is essentially a set of standards for quality in testing cannabis and cannabis-based products, such as infused products, tinctures and concentrates. ISO 17025 accreditation is quickly become a desirable certification for laboratories. Many states strongly encourage or even require ISO 17025 accreditation for cannabis laboratories. California recently released a set of proposed lab testing regulations for the cannabis industry that specifically requires an ISO 17025 accreditation in order for laboratories to issue certificates of analysis.

Because each state’s requirements for laboratories testing cannabis varies so greatly, A2LA works with state regulators to craft their accreditation program to meet each state’s specific requirements. “A2LA is excited to play such an important role in the accreditation of cannabis testing laboratories and is pleased to see ISO/IEC 17025 accreditation expanding into additional states,” says A2LA General Manager Adam Gouker. “Priority must be placed on ensuring that cannabis products are tested by competent laboratories to convey confidence in the results – a cornerstone which underpins the safety to all end-users.” A2LA is currently accepting applications for cannabis laboratories working to receive accreditation. Labs that already have ISO 17025 accreditation and are in a state with legal cannabis, have the ability to expand their scope of accreditation if they are looking to get into cannabis testing.

Cannabis-Specific Certified Reference Materials

By Aaron G. Biros, Don Shelly
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A certified reference material (CRM) is generally recognized as providing the highest level of traceability and accuracy to a measurement. A CRM designed specifically for cannabis testing and tailored to state-specific testing regulations could help laboratories better ensure the safety of their products.

The fact that a certificate accompanies a reference material does not qualify it as a CRM. The reference material must be produced in accordance with ISO Guide 34 specifications by an accredited manufacturer. Adam Ross, key account manager and organic specialist at LGC Standards, says accreditation is a big part of bringing legitimacy to cannabis testing. “For a laboratory to receive an ISO 17025 accreditation, they must purchase their RMs from an ISO 17025 manufacturer. The best option is to purchase an ISO Guide 34 manufactured CRM,” says Ross. “It is particularly important for testing requirements, such as potency, pesticides, etc., where quantitation is expected, to use properly certified quantitative reference materials.” LGC Standards, a 175-year-old company, is one of those manufacturers that invested the time and money to achieve ISO Guide 34 accreditation and offers a spectrum of CRMs for cannabis testing.

Adam Ross, LGC Standards
Adam Ross, LGC Standards

The major advantage to using a proper CRM is an increased level of credibility. Auditors recognize the value of using a CRM which can add to the integrity of the results produced. The regular use of certified reference standards along with proper training, methodology and instrumentation, will facilitate a result that has the least amount of uncertainty and is more defendable. “The regular use of certified reference standards will help ensure products that go to market are safe to consume,” says Ross.

With regard to potency analyses, Ross has some key insights to help a laboratory better utilize CRMs. “My advice? Don’t mix the cannabinoids; labs analyzing by GC/FID have discovered that some of the cannabinoids will co-elute. Also, they have a short shelf life when mixed together,” says Ross. “Cannabinoid analysts should use GC/MS or LC/MS for their analysis or analyze the cannabinoids individually,” says Ross.

rsz_cannabis_product_photo_lgc-1So what happens if a cannabis lab uses non-certified reference materials? Labs might save money in the short term. CRMs are slightly more expensive than a non-certified reference material, but will increase the defensibility of a lab’s data. Using a reference material created in-house or from a non-accredited vendor can lead to less-than-accurate results. A non-certified reference material has a greater chance of being made incorrectly. The publication of incorrect data damages the credibility of the testing lab and could lead to legal action against the lab from damaged parties.

One of the major challenges for the cannabis testing industry is the variation in state-to-state regulations. Ross says that Oregon’s regulations are pretty comprehensive and that other states should look to the Oregon Environmental Laboratory Accreditation Program (ORELAP) for guidance. According to Ross, ORELAP would like to see higher quality standards with legitimate traceability. Utilizing CRMs the correct way will help laboratories achieve greater accuracy.

Here are some tips for using CRMs appropriately:

  • Always bring your standards to room temperature before making a dilution.
  • Matrix matched calibration standards provide more accurate quantitation. Prepare standards in the solvent from extracted blank matrices.
  • Always bracket your analytical runs with continuing calibration verification standards. Proving that your instrument remained calibrated during the run gives your data more credibility.

Analytical chemists purchase CRMs for three primary uses in the testing lab:

  • To calibrate the instrument that will be used to perform the testing
  • To confirm the instruments continuing calibration throughout the analytical process
  • For analytical quality control or “spikes”

Typically, labs will spike known concentrations of the analytes of interest into a control sample and regular samples with the intent of testing analytical efficiency. Recoveries of analytes from the spiked control sample tell the chemist how well the analytical method is working. The spiked samples (matrix spikes) demonstrate to what extent the sample matrix (the consumable being tested) is influencing the results of the analytical procedure.

CRMs could be described as the nexus between cannabis testing results, the human element and the instrumentation used in an analysis. By using a cannabis-specific CRM, the cannabis testing community can demonstrate tangible improvements in accuracy and legitimacy.