Tag Archives: extraction

Two Recalls Hit California Cannabis Market

By Aaron G. Biros
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Just weeks ago, the first voluntary cannabis product recall occurred under California’s new regulations. According to an article on MJBizDaily.com by John Schroyer, the recall for their vaporizer cartridges affects almost 100 dispensaries in California.

Bloom Brands, the company issuing the voluntary recall, mentioned in a press release that batches sold between July 1-19, 2018 were contaminated with the pesticide Myclobutanil and therefore does not meet the Bureau of Cannabis Control (BCC) standards. Below is an excerpt from the press release:

We are working closely with the BCC to remedy this issue and expect clean, compliant products to be back on shelves in three weeks…. At Bloom, we are continuing to work with the BCC and other partners to ensure that the space is properly regulated and safe for all customers. Transparency and safety remain our top concerns and we will provide updates as additional information becomes available. We apologize for any concern or inconvenience this serious misstep has caused. We thank you for your continued trust and confidence in our products.

Then, just days later, Lowell Herb Co. issued a voluntary recall on their pre-rolls. First reported by MJBizDaily.com, it appears the products initially passed multiple lab tests and was cleared for retail sales. Weeks after the batch passed tests, a laboratory reversed its decision, saying the products failed to pass the state’s testing standards. The contaminant in question was not mentioned.

The CCIA post calling out the BCC
The CCIA post calling out the BCC

Many seem to think these recalls are a product of the BCC’s unrealistic expectations in their lab testing rules. In a Facebook post days ago, the California Cannabis Industry Association called out the BCC for their unworkable rules. “The BCC has set testing standards that are nearly impossible to meet,” reads the post. “As a result recalls like this will be the norm and the industry will suffer a bottleneck in supply. Testing standards need to be realistic, not impossible.”

On July 13, California issued the first draft of their proposed permanent regulations, which would update and change the current emergency regulations. The proposed action levels for a batch to pass a pesticide test can be found on pages 105 and 106. The state’s regulatory bodies are holding public meetings on the proposed rules throughout August and stakeholders can also submit comments via email.

Dr. Ed Askew
From The Lab

Quality Plans for Lab Services: Managing Risks as a Grower, Processor or Dispensary, Part 4

By Dr. Edward F. Askew
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Dr. Ed Askew

In the last three articles, I discussed the laboratory’s responses or defenses used to reply to your questions about laboratory results that place stress on the success of your business. The Quality Control (QC) results can cause this stress if they are not run correctly to answer the following questions:

  1. Are the laboratory results really true?
  2. Can the laboratory accurately analyze sample products like my sample?
  3. Can the laboratory reproduce the sample results for my type of sample?

Now let’s discuss the most important QC test that will protect your crop and business. That QC sample is the Matrix Sample. In the last article in this series, you were introduced to many QC samples. The Matrix Sample and Duplicate were some of them. Take a look back at Part 3 to familiarize yourself with the definitions.

The key factors of these QC sample types are:

  1. Your sample is used to determine if the analysis used by the laboratory can extract the analyte that is being reported back to you. This is performed by the following steps:
    1. Your sample is analyzed by the laboratory as received.
    2. Then a sub-sample of your sample is spiked with a known concentration of the analyte you are looking for (e.g. pesticides, bacteria, organic chemicals, etc.).
    3. The difference between the sample with and without a spike indicates whether the laboratory can even find the analyte of concern and whether the percent recovery is acceptable.
    4. Examples of failures are from my experiences:
      1. Laboratory 1 spiked a known amount of a pesticide into a wastewater matrix. (e.g. Silver into final treatment process water). The laboratory failed to recover any of the spiked silver. Therefore the laboratory results for these types of sample were not reporting any silver, but silver may be present. This is where laboratory results would be false negatives and the laboratory method may not work on the matrix (your sample) correctly. .
      2. Laboratory 2 ran an analysis for a toxic compound (e.g. Cyanide in final waste treatment discharge). A known amount of cyanide was spiked into a matrix sample and 4 times the actual concentration of that cyanide spike was recovered. This is where laboratory results would be called false positives and the laboratory method may not work on the matrix (your sample) correctly.
  2. Can the laboratory reproduce the results they reported to you?
    1. The laboratory needs to repeat the matrix spike analysis to provide duplicate results. Then a comparison of the results from the first matrix spike with its duplicate results will show if the laboratory can duplicate their test on your sample.
      1. If the original matrix spike result and the duplicate show good agreement (e.g. 20% relative percent difference or lower). Then you can be relatively sure that the result you obtained from the laboratory is true.
      2. But, if the original matrix spike result and the duplicate do not show good agreement (e.g. greater than 20% relative percent difference). Then you can be sure that the result you obtained from the laboratory is not true and you should question the laboratory’s competence.

Now, the question is why a laboratory would not perform these matrix spike and duplicate QC samples? Well, the following may apply:

  1. These matrix samples take too much time.
  2. These matrix samples add a cost that the laboratory cannot recover.
  3. These matrix samples are too difficult for the laboratory staff to perform.
  4. Most importantly: Matrix samples show the laboratory cannot perform the analyses correctly on the matrix.

So, what types of cannabis matrices are out there? Some examples include bud, leaf, oils, extracts and edibles. Those are some of the matrices and each one has their own testing requirements. So, what should you require from your laboratory?

  1. The laboratory must use your sample for both a matrix spike and a duplicate QC sample.
  2. The percent recovery of both the matrix spike and the duplicate will be between 80% and 120%. If either of the QC samples fail, then you should be notified immediately and the samples reanalyzed.
  3. If the relative percent difference between the matrix spike and the duplicate will be 20% or less. If the QC samples fail, then you should be notified immediately and the samples should be reanalyzed.

The impact of questionable laboratory results on your business with failing or absent matrix spike and the duplicate QC samples can be prevented. It is paramount that you hold the laboratory responsible to produce results that are representative of your sample matrix and that are true.

The next article will focus on how your business will develop a quality plan for your laboratory service provider with a specific focus on the California Code Of Regulations, Title 16, Division 42. Bureau Of Cannabis Control requirements.

Orange Photonics Introduces Terpenes+ Module in Portable Analyzer

By Aaron G. Biros
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Last week at the National Cannabis Industry Association’s (NCIA) Cannabis Business Summit, Orange Photonics unveiled their newest product added to their suite of testing instruments for quality assurance in the field. The Terpenes+ Module for the LightLab Cannabis Analyzer, which semi-quantitatively measures terpenes, Cannabichromene (CBC) and degraded THC, adds three new chemical analyses to the six cannabinoids it already reports.

CBC, a cannabinoid typically seen in hemp and CBD-rich plants, has been linked to some potentially impactful medical applications, much like the findings regarding the benefits of CBD. The module that tests for it, along with terpenes and degraded THC, can be added to the LightLab without any changes to hardware or sample preparation.

Dylan Wilks, chief technology officer of Orange Photonics
Dylan Wilks, chief technology officer of Orange Photonics

According to Dylan Wilks, chief technology officer of Orange Photonics, this could be a particularly useful tool for distillate producers looking for extra quality controls. Cannabis distillates are some of the most prized cannabis products around, but the heat used to create them can also create undesirable compounds,” says Wilks. “Distillate producers can see potency drop more than 25% if their process isn’t optimized”. With this new Terpenes+ Module, a distillate producer could quantify degraded THC content and get an accurate reading for their QC/QA department.

We spoke with Stephanie McArdle, president of Orange Photonics, to learn more about their instruments designed for quality assurance for growers and extractors alike.

Stephanie McArdle, president of Orange Photonics
Stephanie McArdle, president of Orange Photonics

According to McArdle, this could help cultivators and processors understand and value their product when terpene-rich products are the end goal. “Rather than try to duplicate the laboratory analysis, which would require expensive equipment and difficult sample preparation, we took a different approach. We report all terpenes as a single total terpene number,” says McArdle. “The analyzer only looks for monoterpenes (some common monoterpenes are myrcene, limonene and alpha-pinene), and not sesquiterpenes (the other major group of cannabis terpenes, such as Beta- Caryophyllene and Humulene) so the analysis is semi-quantitative. What we do is measure the monoterpenes and make an assumption that the sesquiterpenes are similar to an average cannabis plant to calculate a total terpene content.” She says because roughly 80% of terpenes found in cannabis are monoterpenes, this should produce accurate results, though some exotic strains may not result in accurate terpene content using this method.

The LIghtLab analyzer on the workbench
The LIghtLab analyzer on the workbench

As growers look to make their product unique in a highly competitive market, many are looking at terpenes as a source of differentiation. There are a variety of areas where growers can target higher terpene production, McArdle says. “During production, a grower may want to select plants for growing based on terpene content, or adjust nutrient levels, lighting, etc. to maximize terpenes,” says McArdle. “During the curing process, adjusting the environmental conditions to maximize terpene content is highly desirable.” Terpenes are also beginning to get recognized for their potential medical and therapeutic values as well, notably as an essential piece in the Entourage Effect. “Ultimately, it comes down to economics – terpene rich products have a higher market value,” says McArdle. “If you’re the grower, you want to prove that your product is superior. If you’re the buyer, you want to ensure the product you buy is high quality before processing it into other products. In both cases, knowing the terpene content is critical to ensuring you’re maximizing profits.”

Orange Photonics’ LightLab operates very similarly to instruments you might find in a cannabis laboratory. Many cannabis testing labs use High Performance Liquid Chromatography (HPLC) to analyze hemp or cannabis samples. “The primary difference between LightLab and an HPLC is that we operate at lower pressures and rely on spectroscopy more heavily than a typical HPLC analysis does,” says McArdle. “Like an HPLC, LightLab pushes an extracted cannabis sample through a column. The column separates the cannabinoids in the sample by slowing down cannabinoids by different amounts based on their affinity to the column.” McArdle says this is what allows each cannabinoid to exit the column at a different time. “For example, CBD may exit the column first, then D9THC and so on,” says McArdle. “Once the column separates the cannabinoids, they are quantified using optical spectroscopy- basically we are using light to do the final quantification.”

Soapbox

5 Things You Can Do To Get the Most Value From Your Consultant

By Vince Sebald
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I worked for about 18 years as a company employee in various levels from entry-level engineer to senior director. Since then I have spent over a decade as a consultant in the life science industry as the founder of Sebald Consulting. Presently, I also use consultants as CEO of GxPready!, a web based CMMS software company. Based on this experience, I have put together a top 5 list of things you can do to get the most value when using consultants:

1. Recognize when a project requires a consultant

There can be several reasons a project may benefit from having a consultant which may include bringing a new skill set, industry experience or an outside perspective to bear on a project that is not available otherwise.

Provide clear guidance as to what the task and deliverables are on an ongoing basis.Also, there are occasions when resources are already stretched and you need short-term support to get through an intensive segment of a project, but the work may not be enough to justify additional longer-term resources.

In any of these cases, filling the gap internally can be difficult and time consuming. A consultant can be a great solution. Even if you don’t plan to use a consultant for the project, it may be to your benefit to have a consultant perform a “gap assessment” to help you to identify areas which require improvement to meet compliance requirements or best practice guidelines. This is often done to prepare for audits, for example.

2. Vet the consultant to get a good match

Contact potential consultants to determine if they have the set of skills you are looking for and if they fit within the culture of your organization. Talk to the actual consultant you will be working with before bringing them on.  Review the consulting contract carefully to make sure the terms are mutually acceptable.  Often consultants have some flexibility to accommodate different project situations.

One advantage to using consultants is that you don’t have a long commitment so even after you vet them with interviews, you can work on small projects and gauge the results. Some consulting companies are very formal and others are less so, for example. A good fit is better for both parties. It’s not just the competence, but the culture and personal fit with your team.

3. Provide the consultant with appropriate guidance and resources

Help the consultant give you the best results possible by providing access to the resources (personnel, information, documents, systems, etc.) to allow the consultant to perform the tasks.

Consultants can help you get through unfamiliar territory or help you to manage your team’s workload. Know how to use these resources to benefit your projects. This project manager called just in time.

Provide clear guidance as to what the task and deliverables are on an ongoing basis.

Alternatively, allow the consultant to manage the project and reach out as necessary. Any guidance and resources you can provide the consultant will increase the effectiveness and help control your costs on the project.

If you don’t know exactly what needs to be done (“That’s why I hired a consultant!”) then have the consultant put together a list for you based on some general guidance and then work from that list to get your job completed.

4. Track progress with appropriate level of detail

If you have vetted and hired a consultant, chances are they are going to put in their best effort to meet your requirements. Nonetheless, it is good practice to have a system in place to track hours/costs.

Whether it is weekly reporting, or based on milestones and project updates, this helps to avoid any misunderstandings and provides opportunities for communication of project issues in addition to whatever project updates may be scheduled.

You want your team of consultants and employees to be able to work as well as possible together.Recognize that you can go overboard in this area, working against yourself and the project, if the tracking is so detailed that it takes excessive resources to document. It is definitely possible to inadvertently generate more hours (and expense) by managing time in too much detail. If the concern is high and heavy management is required, perhaps that indicates the consultant is not the best match for this project.

Generally, you can find a good balance with a simple up-front chat with the consultant to review your expectations, and for larger projects it is often formalized in the contract.

5. Recognize if it’s not a good fit

There are many consultants and clients out there. Inevitably, there are times when, despite best intentions, the consultant/client mix isn’t working out. Make sure the contract allows for management of this situation. Can you cancel the contract with reasonable notice? Is there a mechanism for being able to replace members of the team that aren’t working out?

You want your team of consultants and employees to be able to work as well as possible together. If that’s not happening, recognize it and make adjustments as necessary. But don’t lose the contact information. A consultant that doesn’t work out today may be just right for your next project!

Following the above can improve your chances of success with consultants you may hire and allow you to build a solid set of resources you can call on from time to time as things change in your company. Consultants can fill a vital role for tasks requiring specialized skills or short-term projects where a full time hire is not practical.

2018 Food Safety Consortium

Save the Dates for the 6th Annual Food Safety Consortium conference in Schaumburg, IL, a summit of Food Safety and Quality Assurance (FSQA) industry experts and government officials. The 2018 Food Safety Consortium will have a cannabis track this year where topics will include: regulations, standards, cannabis food safety & quality and much more.

The Importance of Medical Cannabis Trials In Europe

By Marguerite Arnold
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Calls for more testing have been a watchword of both cannabis reform advocates and opponents alike for many years.

However, now is a really good time for cannabis companies to consider sponsoring medical trials across Europe for their cannabis products. This is why:

The Current Environment On The Ground

Germany is Europe’s biggest consumer of both prescription medications and medical devices dispensed by prescription. It is, as a result, Europe’s most valuable drug market. And ground zero for every international cannabis company right now as a result.Targeting Germany for your latest pharmaceutical product is difficult no matter who you are.

Here, however, are a few problems that face every pharma manufacturer, far beyond cannabis. Targeting Germany for your latest pharmaceutical product is difficult no matter who you are.

  1. The vast majority by euro spending on all drugs and devices dispensed by prescription must be pre-approved. To add to this problem, before they can be prescribed, new drugs must get on the radar of doctors somehow. To put this in stark relief, the entire prescription drug and medical device annual spend is about 120 billion euros a year in Germany. Only 20 billion euros of that, however, may be obtained relatively easily (without pre-approval from an insurer). Preapproval also only comes when there is trialor other scientific evidence of efficacy.
  2. There are strict rules banning the advertising of prescription drugs to patients and highly limiting this outreach to doctors.
  3. There are strict rules prohibiting the use of the word “cannabis” to promote anything.
  4. There is a strong reliance on what is called “evidence-based medicine.” That means that large numbers of doctors and insurance company approvers need to see hard data that this drug or device actually works better than what is currently on the market.

How then, is a new drug supposed to get on the radar of those who prescribe the drug? Or patients?

If this sounds like an impossible situation to navigate, do not despair. There is a way out.

The Impact of the European Medicines Agency

This agency has been much in the news of late. Namely, the British do not want to exclude themselves from the regulatory umbrella of this organization.

Largely unknown outside Europe, this agency actually has a hugeinfluence on how drugs are brought into the region. Specifically, this is the EU-wide agency (aka the EMA) that both regulates all drugs within Europe, but has also, since 2016, been making clinical reports submitted by pharmaceutical companies, available to anyone who asks for them. That includes doctors, members of the public and of course, the industry itself.

In the middle of July, the agency also published a report on the success of its now three-year-old program, including the usage of its entry website. Conveniently written in English, it is possible to easily search new trial data, which, also now must be made public.

Medical trial data, in other words, that can be created by sponsored cannabis company backed trials.

It remains the best way to get patients, doctors and insurance companies familiar with new drugs. Or even new uses for old drugs in the case of cannabis.

Will Trials Move Legalization Discussions?

Of all the established cannabis companies now in operations with producton the ground, GW Pharmaceuticals has learned that this strategy can actually cut both ways.GW logo-2

However,there are no other cannabis companies in the position of GW Pharma – namely with a monopoly on a whole country (the UK), where it alone can legally grow cannabis crops and process the same into medication and further for very profitable export. In addition, even more disturbingly, and clearly an era that is coming to an end, the vast majority of British patients have been excluded from access to cannabis except in the case of GW Pharma products.

The current row over expanded medical use in the UK, in fact, was triggered by two things. The failure of the latest GW Pharma trial for drug resistant epilepsy in Eastern Europe. And the deliberate importation by several desperate families, of good old cannabis (CBD) oil into the UK. No medical processing required.

GW Pharma said their product Epidiolex (for the treatment of childhood epilepsy) is being considered by the European Medicines Agency

However, that is the UK.

Other cannabis companies can take a page out of the company’s handbook. All that is required for faster market entry, is a slightly altered recipe.

By sponsoring cannabis-related trials in each country they want to enter, starting with Germany, cannabis companies can literally put themselves on the medical map.

Why?

Because doctors, patients andother researchers will be easily able to see and access country-specific medical data on each use of cannabis covered by a trial, per EU country. All made possible, of course, by the new open door policy of the EMA.

Growing the Medical Market

While this may sound like an “expensive” proposition, there are really few other alternatives. And with no advertising budget, plus a marketing budget that must include outreach to everyone in the supply chain including doctors, distributors and even pharmacies, the trial approach in the end may be the most efficacious in broadening both the demand and market. Not to mention the cheaper option.

How such a trial strategy might be coordinated at a time when domestic cultivation is still on hold is still a question. However for those companies considering market entry and cultivation bid if not domestic processing strategies for their products is an industry strategy that will pay off in spades.

Its role in the legalization of cannabis as medicine, as well as the speedier introduction of new drugs overall into the European system,cannot be underestimated, even if it is currently underutilized by the cannabis industry specifically now.

Lauren Pahnke
From The Lab

Centrifugal Partition Chromatography Paves the Way for Safer, More Standardized Cannabidiol Drugs

By Lauren Pahnke
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Lauren Pahnke

Imagine this: you are taking medication for cancer pain. One day, it works perfectly. The next, you feel no relief. On some days, you need to take three doses just to get the same effect as one. Your doctor can’t be completely positive how much active ingredient each dose contains, so you decide for yourself how much medication to take.

Doesn’t seem safe, right? It is crucial that doctors know exactly what they are prescribing to their patients. They must know that their patients are receiving the exact same dose of medication in their prescription each time they take it, and that their medication contains only the intended ingredients.

consistency is key to creating products that are safe for consumers.In the cannabis industry, lack of certainty on these important factors is a major problem for drug manufacturers as they attempt to incorporate cannabidiol (CBD), a compound found in cannabis that has no psychoactive effects but many medical benefits, into pharmaceutical drugs.

When using these compounds as medications, purity is essential. Cannabis contains a wide variety of compounds. Delta-9 tetrahydrocannabinol (THC) is the most well-known compound and its main psychoactive one1. Safety regulations dictate that consumers know exactly what they are getting when they take a medication. For example, their CBD-based medications should not contain traces of THC.

The cannabis industry greatly needs a tool to ensure the consistent extraction and isolation of compounds. In 2017, the cannabis industry was worth nearly $10 billion, and it is expected to grow $57 billion more in the next decade2. As legalization of medical cannabis expands, interest in CBD pharmaceuticals is likely to grow.

If compounds such as CBD are going to be used in pharmaceutical drugs, consistency is key to creating products that are safe for consumers.

CBD’s Potential

CBD is a non-psychoactive compound that makes up 40 percent of cannabis extracts1. It is great for medical applications because it does not interfere with motor or psychological function. Researchers have found it particularly effective for managing cancer pain, spasticity in multiple sclerosis, and specific forms of epilepsy3.

Figure 1: The chemical structure of cannabidiol.
Figure 1: The chemical structure of cannabidiol.

Other compounds derived from cannabis, such as cannabichromene (CBC) and cannabigerol (CBG), may also be beneficial compounds with medical applications. CBC is known to block pain and inflammation, and CBG is known for its use as a potential anti-cancer agent1.

Along with these compounds that provide medical benefits, there are psychoactive compounds that are used recreationally, such as THC.

“It will definitely be an advantage to have cannabis-based medications with clearly defined and constant contents of cannabinoids,” says Kirsten Müller-Vahl, a neurologist and psychiatrist at Hannover Medical School in Germany.

Creating a Standard Through Centrifugal Partition Chromatography

To obtain purified compounds from cannabis, researchers need to use technology that will extract the compounds from the plant.

Many manufacturers use some sort of chromatography technique to isolate compounds. Two popular methods are high performance liquid chromatography (HPLC) and flash chromatography. These methods have their places in the field, but they cannot be effectively and cost-efficiently scaled to isolate compounds. Instead, HPLC and flash chromatography may be better suited as analytical tools for studying the characteristics of the plant or extract. As cannabis has more than 400 chemical entities4, compound isolation is an important application.

This method is highly effective for achieving both high purity and recovery.Although molecules such as CBD can be synthesized in the lab, many companies would rather extract the compounds directly from the plant. Synthesized molecules do not result in a completely pure compound. The result, “is still a mixture of whatever cannabinoids are coming from a particular marijuana strain, which is highly variable,” says Brian Reid, chief scientific officer of ebbu, a company in Colorado that specializes in cannabis purification.

Currently, there is only one method available to researchers that completely allows them to isolate individual compounds: centrifugal partition chromatography (CPC).

The principle of CPC is similar to other liquid chromatography methods. It separates the chemical substances as the compounds in the mobile phase flow through and differentially interact with the stationary phase.

Where CPC and standard liquid chromatography differs is the nature of the stationary phase. In traditional chromatography methods, the stationary phase is made of silica or other solid particles, and the mobile phase is made of liquid. During CPC, the stationary phase is a liquid that is spun around or centrifuged to stay in place while the other liquid (mobile phase) moves through the disc. The two liquid phases, like oil and water, don’t mix. This method is highly effective for achieving both high purity and recovery. Chemists can isolate chemical components at 99 percent or higher purity with a 95 percent recovery rate5.

“CPC is ideal for ripping a single active ingredient out of a pretty complex mixture,” says Reid. “It’s the only chromatographic technique that does that well.”

The Need for Pure Compounds

High levels of purity and isolation are necessary for cannabis to be of true value in the pharmaceutical industry. Imagine relying on a medication to decrease your seizures, and it has a different effect every time. Sometimes there may be traces of psychoactive compounds. Sometimes there are too much or too little of the compound that halts your seizures. This is not a safe practice for consumers who rely on medications.“It’s hard to do studies on things you can’t control very well.”

Researchers working with cannabis desperately need a technology that can extract compounds with high purity rates. It is hard to run a study without knowing the precise amounts of compounds used. Reid uses a Gilson CPC 1000 system at ebbu for his cannabinoid research. With this technology, he can purify cannabinoids for his research and create reliable formulations. “Now that we have this methodology dialed in we can make various formulations —whether they’re water-soluble, sublingual, inhaled, you name it —with very precise ratios of cannabinoids and precise amounts of cannabinoids at the milligram level,” says Reid.

Kyle Geary, an internist at the University of Illinois at Chicago, is currently running a placebo-controlled trial of CBD capsules for Crohn’s disease. This consistent isolation is helpful for his research, as well. “Ideally, the perfect study would use something that is 100 percent CBD,” says Geary. “It’s hard to do studies on things you can’t control very well.”

The State of the Industry

While CBD is not considered a safe drug compound under federal law in the United States6, 17 states have recently passed laws that allow people to consume CBD for medical reasons7. Half of medicinal CBD users solely use the substance for treatment, a recent survey found8. As the industry quickly grows, it is crucial that consumer safety protocol keeps pace.

In June, the US Food and Drug Administration (FDA) approved the first drug that contains a purified drug substance from cannabis, Epidiolex9. Made from CBD, it is designed to treat Dravet Syndrome and Lennox-Gastaut syndrome, two rare forms of epilepsy. FDA Commissioner Scott Gottlieb said in the news release that although the FDA will work to support the development of high-quality cannabis-based products moving forward, “We are prepared to take action when we see the illegal marketing of CBD-containing products with serious, unproven medical claims. Marketing unapproved products, with uncertain dosages and formulations can keep patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases.”

The industry should be prepared to implement protocols to ensure the quality of their CBD-based products. The FDA has issued warnings in recent years that some cannabinoid products it has tested do not contain the CBD levels their makers claim, and consumers should be wary of such products10. It’s hard to know when or if the FDA will begin regulating CBD-based pharmaceuticals. However, for pharma companies serious about their reputation, there is only one isolation method that creates reliable product quality: CPC.


References:

  1. Lab Manager. (2018, January 3). Cannabinoid Chemistry Infographic. Retrieved from http://www.labmanager.com/multimedia/2017/07/cannabinoid-chemistry-infographic#.WzT2e1MvyMI
  2. BDS Analytics. (2018, February 26). NEW REPORT: Worldwide spending on legal cannabis will reach $57 billion by 2027. Retrieved from https://bdsanalytics.com/press/new-report-worldwide-spending-on-legal-cannabis-will-reach-57-billion-by-2027/
  3. National Institute on Drug Abuse. (2015, June 24). The Biology and Potential Therapeutic Effects of Cannabidiol. Retrieved from https://www.drugabuse.gov/about-nida/legislative-activities/testimony-to-congress/2016/biology-potential-therapeutic-effects-cannabidiol
  4. Atakan, Z. (2012). Cannabis, a complex plant: Different compounds and different effects on individuals. Therapeutic Advances in Psychopharmacology,2(6), 241-254. doi:10.1177/2045125312457586
  5. Gilson. (n.d.). Centrifugal Partition Chromatography (CPC) Systems. Retrieved from http://www.gilson.com/en/AI/Products/80.320#.WzVB2lMvyMI
  6. Mead, A. (2017). The legal status of cannabis (marijuana) and cannabidiol (CBD) under US law. Epilepsy & Behavior, 70, 288-291.
  7. ProCon.org. (2018, May 8). 17 States with Laws Specifically about Legal Cannabidiol (CBD) – Medical Marijuana – ProCon.org. Retrieved from https://medicalmarijuana.procon.org/view.resource.php?resourceID=006473
  8. Borchardt, D. (2017, August 03). Survey: Nearly Half Of People Who Use Cannabidiol Products Stop Taking Traditional Medicines. Retrieved from https://www.forbes.com/sites/debraborchardt/2017/08/02/people-who-use-cannabis-cbd-products-stop-taking-traditional-medicines/#43889c942817
  9. U.S. Food & Drug Administration. (2018, June 25). Press Announcements – FDA approves first drug comprised of an active ingredient derived from marijuana to treat rare, severe forms of epilepsy. Retrieved from https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm611046.htm
  10. U.S. Food & Drug Administration. (2017). Public Health Focus – Warning Letters and Test Results for Cannabidiol-Related Products. Retrieved from https://www.fda.gov/newsevents/publichealthfocus/ucm484109.htm
Radojka Barycki picture

Food Safety: Do You Know What Is In Your Water?

By Radojka Barycki
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Radojka Barycki picture

Water is essential for life and it is an important part of agriculture and food manufacturing. Water has many uses in the cannabis industry. Among the most common uses are irrigation, ingredient/product processing and cleaning processes.

Water can be the carrier of pathogenic microorganisms and chemicals that can be transferred to food through agriculture and manufacturing practices. Poor quality water may have a negative impact in food processing and potentially on public health. Therefore, development and implementation of risk management plans that ensure the safety of water through the controls of hazardous constituents is essential to maintain the safety of agricultural and manufactured food or cannabis products.

Chemicals can enter the water stream through several sources such as storm water, direct discharge into fields and city water treatment plans.Although there no current regulations regarding the water used in cannabis cultivation and processing, it is highly recommended that the industry uses potable water as standard practice. Potable water is water that is safe for drinking and therefore for use in agriculture and food manufacturing. In the United States, the Environmental Protection Agency (EPA) sets the standards for water systems under the Safe Drinking Water Act (SDWA.)The regulations include the mandatory levels defined as Maximum Contaminant Levels (MCLs) for each contaminant that can be found in water. Federal Drinking Water Standards are organized into six groups: Microorganisms, Disinfectants, Disinfection Byproducts, Inorganic Chemicals, Organic Chemicals and Radionuclides. The agriculture and food manufacturing industry use the SDWA as a standard to determine water potability. Therefore, water testing forms part of their routine programs. Sampling points for water sources are identified, and samples are taken and sent to a reputable laboratory to determine its quality and safety.

Microbiological Testing

Petri dish containing the fungus Aspergillus flavus
Petri dish containing the fungus Aspergillus flavus.
Photo courtesy of USDA ARS & Peggy Greb.

Determining the safety of the water through microbiological testing is very important. Pathogens of concern such as E. coli, Salmonella, Cryptosporidium parvum and Cyclospora sp. can be transmitted to food through water. These pathogens have been known to be lethal to humans, especially when a consumer’s immune system is compromised (e.g. cancer patients, elderly, etc.) If your water source is well, the local state agency may come to your facility and test the water regularly for indicator organisms such as coliforms. If the levels are outside the limit, a warning will be given to your company. If your water source is the city, regular testing at the facility for indicator microorganisms is recommended. In each case, an action plan must be in place if results are unfavorable to ensure that only potable water is used in the operations.

Chemical Testing (Disinfectants, Disinfection Byproducts, Inorganic Chemicals, Organic Chemicals and Radionuclides) 

Chemicals can enter the water stream through several sources such as storm water, direct discharge into fields and city water treatment plans. Although, there are several regulations governing the discharge of chemicals into storm water, fields and even into city water treatment plants, it is important that you test your incoming water for these chemicals on a regular basis. In addition, it is important that a risk assessment of your water source is conducted since you may be at a higher risk for certain components that require testing. For example, if your manufacturing facility is near an agricultural area, pesticides may enter the surface water (lakes, streams, and rivers) or the aquifer (ground water) through absorption into the ground or pollution. In this case, you may be at higher risk for Tetrahalomethanes (THMs), which are a byproduct of pesticides. Therefore, you should increase the testing for these components in comparison to other less likely to occur chemicals in this situation. Also, if your agriculture operation is near a nuclear plant, then radionuclides may become a higher risk than any of the other components.

GMPFinally, in addition to the implementation of risk management plans to ensure the safety of water, it is highly recommended that companies working in food manufacturing facilities become familiar with their water source to ensure adequate supply to carry on their operations, which is one of the requirements under the 21 CFR 117. Subpart B – Current Good Manufacturing Practices (cGMPs) for food manufacturers under the Preventive Controls for Human Foods Rule that was enacted under the Food Safety Modernization Act in 2015. Also, adequate supply is part of the Good Agricultural Practices (GAP) The EPA has created a program that allows you to conduct a risk assessment on your water source. This program is called Source Water Protection. It has six steps that are followed to develop a plan that not only protect sourcing but also ensures safety by identifying threats for the water supply. These six steps are:

  1. Delineate the Source Water Protection Area (SWPA): In this step a map of the land area that could contribute pollutants to the water is created. States are required to create these maps, so you should check with local and/or state offices for these.
  2. Inventory known and potential sources of contamination: Operations within the area may contribute contaminants into the water source. States usually delineates these operations in their maps as part of their efforts to ensure public safety. Some examples of operations that may contribute to contaminants into the water are: landfill, mining operations, nuclear plants, residential septic systems, golf courses, etc. When looking at these maps, be sure that you verify the identified sources by conducting your own survey. Some agencies may not have the resources to update the maps on a regular basis.
  3. Determine the susceptibility of the Public Water Source (PWS) to contaminate sources or activities within the SWPA: This is basically a risk assessment. In here you will characterize the risk based on the severity of the threat and the likelihood of the source water contamination. There are risk matrices that are used as tools for this purpose.
  4. Notify the public about threats identified in the contaminant source inventory and what they mean to the PWS: Create a communication plan to make the State and local agencies aware of any findings or accidents in your operation that may lead to contamination of the PWS.
  5. Implement management measures to prevent, reduce or eliminate risks to your water supply: Once risks are characterized, a plan must be developed and implemented to keep risks under control and ensure the safety of your water.
  6. Develop contingency planning strategies that address water supply contamination or service interruption emergencies: OSHA requires you to have an Emergency Preparedness Plan (EPP). This plans outlines what to do in case of an emergency to ensure the safety of the people working in the operation and the continuity of the business. This same approach should be taken when it comes to water supply. The main questions to ask are: a) What would we do if we find out the water has been contaminated? b) What plan is in place to keep the business running while ensure the safety of the products? c) How can we get the operation back up and running on site once the water source is re-stablished?

The main goal of all these programs is having safe water for the operations while keeping continuity of the business in case of water contamination.

Steven Burton
Soapbox

Which Safety Standards Work Best for the Cannabis Industry?

By Steven Burton
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Steven Burton

Now that governments are legalizing cannabis around the world, the question looms for cannabis businesses seeking legitimacy in the new industry: what safety standards should apply? This question is more difficult as different jurisdictions grapple with defining and implementing legal requirements and struggle to keep up with the pace of growth.

For visionary cannabis business, it makes sense to anticipate requirements – not only from governments, but also from consumers and partners. Most regulations currently focus on security and basic health issues but, in the long-term, the industry that may offer the best model for cannabis businesses isn’t pharmaceuticals, but food. Cannabis (especially edibles) share similar hazards and traceability challenges with food products, so taking the lead from the food industry will be much more applicable and could offer greater benefits.

marijuana buds drying in racks biotrackthc
Dried cannabis curing with RFID tags as part of a traceability system.

Companies that achieve the highest and most flexible certification will enjoy a crucial competitive advantage when it comes to winning market share, popularity and consumer trust. Let’s take a quick look at the different options of food safety (and quality) certifications that cannabis businesses may consider. But first, let’s clarify two important definitions that are necessary to understand the food industry.

Basic Concepts from the Food Industry

The first acronym you should be aware of is GFSI, the Global Food Safety Initiative. GFSI is a food industry-driven global collaboration body created to advance food safety. When it comes to understanding GFSI, the important part to note is that certifications recognized by GFSI (like SQF, FSSC 22000, and BRC) are universally accepted. Companies operating under GFSI-recognized certifications open the most doors to the most markets, providing the highest potential for growth. For this reason, cannabis companies should be aware of and seriously consider seeking GFSI certifications

HACCPSecondly, many food safety programs are built around Hazard Analysis Critical Control Points, or HACCP. While many people may talk about HACCP like it’s a certification in and of itself, it is not actually a certification like the others on this list, but rather a methodology that helps companies systematically identify and control biological, chemical, and physical hazards that may arise during food production, handling, and distribution. Companies that adopt this methodology end up with a HACCP plan, which must then be followed at all times to avoid and address health and safety issues. It’s often required for food businesses and is generally required in most of the world, except where ISO 22000 is more common, primarily in Europe and countries whose primary export market is European. Since HACCP plans are also incorporated into most of the other achievable certifications, developing a HACCP program early will build a strong foundation for higher levels of certification.

Certifications for the Cannabis Industry

Now that we understand the basics of GFSI and HACCP, we can see how the certifications that have been developed by and for the food industry may apply to cannabis companies – and which you should consider necessary for your business.

GMP: Good Manufacturing Practice Certification

GMP (or sometimes cGMP) certification requires that companies abide by a set of good manufacturing processes for food and beverage products, pharmaceuticals, cosmetics, dietary supplements and medical devices. Since it really only covers basic sanitation and employee hygiene, it is considered the lowest level of certification in the industry. It is not recognized by GFSI, but GFSI does require all the standard benchmarks of a GMP be met before granting GFSI certification.

While GMP certification is often required, it is far below the standard that should be upheld by any serious businesses. It doesn’t cover many of the different types of hazards associated with food production – that I have argued will become increasingly relevant to cannabis producers – and doesn’t provide a systematic approach to identifying and controlling hazards like a HACCP program would. It’s really just about providing the basic procedures and checks to ensure that the facility is clean and that employees aren’t contaminating the products.GMP

Final Verdict: Recommended, but as the bare minimum. GMP is not sufficient on its own to adequately control the risk of recalls and foodborne illness outbreaks, and it limits a company’s market potential because it lacks the GFSI worldwide stamp of approval.

Some companies consider GMP certification a good place to start if you’re on a tight deadline for distribution in markets where only GMP is required by regulators. I would argue that striving for the minimum standards will be costly in the long run. Health, safety and quality standards are the foundations upon which winning companies are built. It’s critical to develop a corporate culture that will lead to GFSI-recognized programs without major organizational overhaul. Start on the right foot and set your sights higher – obtain a certification that will stand the test of time and avoid the pain and risks of trying to change entrenched behaviors.

SQF: Safe Quality Food Program Certification

SQF is my number one recommendation as the best certification for the cannabis industry. One of the most common certifications in North America, SQF is a food safety management system recognized by retailers and consumers alike. It is administered by the Food Marketing Institute (FMI) and, importantly, recognized by GFSI, which gives companies a huge competitive edge. SQF focuses on the whole supply chain.

SQF was also the first to develop a cannabis program and is currently the leader in this market segment. It is also the scheme that best integrates food safety with quality. Since it is recognized worldwide, SQF provides the greatest leverage to accelerate a company’s growth. Once obtained, products with SQF certification can often jump the queue to enter different regulatory markets.

Final verdict: Highly recommended. A cannabis company with an SQF certification has the greatest advantage because it offers the broadest worldwide reach and keeps companies a step ahead of competitors. It’s also achievable – just this past April, Curaleaf Florida ostensibly became the first cannabis company to achieve SQF certification. It is tough, but fair and practical.

Other Certification Standards

SQF is the top certification that should be considered by cannabis companies, especially outside of Europe. However, the food industry has several other major types of standards that, at this time, have limited relevance to the cannabis industry today. Let’s take a quick look.

When considering GFSI-recognized programs, the main choice for food companies is between SQF, which we’ve covered, and BRC (the British Retail Consortium Certification). BRC has the most in common with SQF but, while SQF was originally developed for processed foods, BRC was developed in the UK for meat products. Today, they are quite similar, but BRC doesn’t focus quite as much on the quality component as SQF does. While BRC could be a good option, they don’t have a program for cannabis and, thus far, do not appear to be as friendly toward the cannabis industry.The food industry has a lot to offer cannabis companies that are anticipating future regulatory changes and market advantages 

Across the pond, there are a few other certification standards that are more common than SQF. One of these is ISO 22000, which is the certification for the food-related standard created by the International Organization for Standardization (ISO) in Europe. It is not recognized by GFSI but is the primary system used in Europe. If your market is exclusively in the EU, it might be a good choice for you in the future. However, to date, there is no indication that any cannabis company has achieved ISO 22000 certification. Some cannabis companies have attained certification for other ISO standards like ISO 9001:2015, which specifies requirements for quality control systems, and ISO/IEC 17025 for laboratory testing. These are generally more relevant for the pharmaceutical industry than food and beverage, but still apply to cannabis.

There is the perception that cannabis is more accepted in EU countries like the Netherlands, but the regulatory attitude to cannabis is complicated. In the Netherlands, for example, cannabis isn’t actually legal – “coffee shops” fall under a toleration policy that doesn’t include regulation. Medical cannabis in the Netherlands is all produced by one supplier and several countries in the EU allow for licensed distribution and import, but not domestic production. Various EU countries are trying to keep up with the legalization trend, however. The Czech Republic, Germany, and others all recently introduced legislation for domestic production of cannabis for medical use. For companies with their eye on the EU, it is crucial to watch which regulatory requirements will be implemented in each market and how.

The last certification standard to mention is the result of a compromise between ISO and the more HACCP oriented programs like SQF. FSSC 22000 (Food Safety System Certification) tries to address the gaps between ISO 22000 and GFSI-recognized certifications by introducing another component called PAS 220. Since it is recognized by GFSI, FSSC 22000 is starting to get more traction in the food industry because it makes products a bit easier to export to the EU. FSSC 22000 satisfies the EU ISO standards but isn’t as closely tied to HACCP. We will be keeping an eye on this one.

Final Takeaway

The food industry has a lot to offer cannabis companies that are anticipating future regulatory changes and market advantages – but it’s difficult for cannabis companies to understand all the options available and how each apply to their specific products. While markets adjust beyond the preliminary issue of legality, it’s crucial for companies to look forward and comply with safety and quality standards like SQF. Companies who strive for SQF certification (or other GFSI-recognized certifications as they become available) will find themselves far better prepared to seize market share as cannabis markets blossom.

EVIO Logo

EVIO Labs Berkeley Accredited To ISO 17025

By Aaron G. Biros
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EVIO Logo

According to a press release, EVIO Inc. announced recently that their Berkeley, California testing lab, C3 Labs, LLC doing business as EVIO Labs, received their ISO 17025 accreditation from Perry Johnson Laboratory Accreditation, Inc. (PJLA). EVIO Inc. acquired C3 Labs in January of this year, but C3 Labs is a well-established cannabis-testing lab that has been serving the Northern California industry since 2015.

The new and improved EVIO Berkeley laboratory
The new and improved EVIO Berkeley laboratory

The accreditation and announcement were well-timed given the California regulatory changes that came on July 1, essentially requiring all cannabis products be tested for a range of contaminants before sold in a retail setting. The press release states EVIO Labs Berkeley should be well equipped to handle the surge in demand for testing services and is prepared for the new regulations.

Ron Russak, vice president of operations at EVIO Labs
Ron Russak, vice president of operations at EVIO Labs

According to Ron Russak, vice president of operations at EVIO Labs, they hope these regulations can give producers, retailers and consumers assurance that their products are safe. “EVIO is committed to upholding the highest standards throughout each step of the testing process and we are extremely pleased with the team’s hard work to reach this great achievement,” says Russak. “As the California cannabis industry evolves and state-mandated laboratory standards of operation prove vital, both clients and consumers will now have assurance that the results will be accurate and reliable.”

In June, we spoke with the EVIO team as they were gearing up for the July 1 phase-in of the new rules. They said they were expanding their capacity in anticipation of a higher demand for lab testing services, including adding more resources, equipment and personnel.