Tag Archives: standards

May 31, 2024

Don’t Reinvent the Wheel: A Tour of ASTM Standards for Cannabis – Part 1

By Bethany Moore, David Vaillencourt

In the realm of consumer safety, minimum standards form a critical safety net that allows businesses and regulators alike with necessary guidelines. From our food and medicines, railroad tracks to bicycle helmets, crayons to cribs, standards are everywhere. Knowing where the lanes are and how to move inside of them provides the structure needed to guide manufacturers forward. And the cannabis and hemp industry is no exception. Why would it be?

In this series of articles, we will explore specific ASTM International standards that have already been developed and published by its Committee on Cannabis (commonly referred to by its Committee designation number – D37). With a frustrating lack of federal clarity, states are increasingly adopting these standards directly into their rules — and for good reason! These standards have gone through an extensive and rigorous process of achieving consensus, adhering to the principles set out by the World Trade Organization to reduce technical barriers to trade. These principles cover openness, balance, and transparency, and are one of many reasons why ASTM standards are confidently adopted into regulations by the US Federal Government. It is no wonder state regulators are increasingly leaning into those standards with confidence when creating rules and regulations for operators in the cannabis industry.

There are numerous benefits to standards adoption, including taking the guesswork out of the “how,” and streamlining operations, particularly when companies wish to scale up and expand. To provide color and context to the fuzzy world of standards, we will include insights from ASTM committee members who were involved in the hands-on process of standards development, including Kim Stuck of Allay Consulting, Dr. David Nathan of D4DPR (Doctors For Drug Policy Reform), and Dr. John DeVries.

“ASTM has been around for over a century, and it is common practice for governments to adopt the standards that have been written by their committees. It takes so much time and effort to put together standards to create safe and consistent products that it just makes sense for governments to adopt already written standards from a trusted source such as ASTM rather than spending the time and money writing a set of their own that will most likely mirror the ASTM standards. The cannabis standards that we have been developing since 2017 have also been written by experts in the industry so that no corner of the industry will be left unregulated,” said Kim Stuck of Allay Consulting, a strategic partner of The GMP Collective, and a participating member of the ASTM D37 Cannabis Committee.

“The process that ASTM uses has been proven to create the most well-rounded and consistent standards, and I am proud to be a part of the process,” Stuck continued. “ASTM International plays a pivotal role in the cannabis industry by providing comprehensive, science-based standards that guide the production, testing, and distribution of cannabis products. The development and implementation of these standards ensure consistent quality, safety, and efficacy across the industry, fostering trust among consumers, regulators, and industry stakeholders.”

HACCP Systems

The same program that was developed by the US Army, NASA, and Pillsbury to keep astronauts from getting sick in outer space is arguably one of the best standards for any cannabis operator to implement in their own operation. The Subcommittee on Quality Management Systems (D37.02) realized and did just that, developing the HACCP System standard, which provides general guidance for implementation in order to prevent, control, or minimize hazards (biological, chemical, or physical) to an acceptable level. The standard can be accessed by anyone with an active ASTM membership, or purchased individually for just $63. As of publication, this standard has been adopted in 3 states, including Oklahoma where it is recommended, New Mexico where it is required for medical applications, and Colorado, which is required as of July 2024 for growers who want a microbial-reduced testing allowance.

“Regarding the specific HACCP (Hazard Analysis and Critical Control Points) standard I was involved in developing, its application in the cannabis industry establishes a proactive approach to identifying, evaluating, and controlling potential hazards throughout the production and distribution process. This standardization is vital for ensuring product safety, quality assurance, and compliance with regulatory requirements.

“HACCP helps the industry minimize risks and prevent contamination, leading to safer products for consumers. By implementing these standards, businesses can provide greater transparency and build consumer confidence in their products. This, in turn, supports the industry’s growth and fosters a safer marketplace while also mitigating risk and preventing costly recalls and fines.

“Regulators and lawmakers rely on such standards because they offer a structured and consistent framework for assessing safety and quality in the industry. Having robust, science-based standards like HACCP helps establish clear benchmarks for producers to meet, ensuring consumer safety and facilitating effective regulation and enforcement. By adhering to these standards, the cannabis industry can gain legitimacy and support from both regulators and consumers,” added Stuck.

Universal Symbol

The most symbolic standard published by the D37 Cannabis Committee is just that: a valuable consumer-facing symbol recommended for use on the packaging of any consumer product that may contain a level of intoxicating cannabinoids. The symbol can be stamped onto edibles like gummies and chocolate, and/or included on packaging. The standard solves an issue that came out of the patchwork regulatory systems from state to state, where each state, upon rolling out rules and regulations, essentially made it up as they went along, developing their own symbols due to not being able to point to a universal standard. This symbol now exists, paving the way for a streamlined process as new states legalize cannabis for medical or adult use.

Dr. David Nathan, Founder and Past President of D4DPR, was a key leader in the development of this standard which is already in adoption across multiple states. “The International Intoxicating Cannabinoid Product Symbol (IICPS) is a harmonized, universal cannabis product symbol that was developed and approved as consensus standard ASTM D8441 by ASTM International through a unanimous vote of over 200 professionals and experts from the public and private sectors. The National Technology Transfer and Advancement Act (NTTAA) mandates federal use of consensus standards, so the IICPS is poised to become the national cannabis product symbol when cannabis is legalized at the federal level,” Dr. Nathan said. The standard can be accessed through ASTM membership or purchased for a fee of $55.

Since its introduction in 2022, the IICPS has already been incorporated into the universal symbol of four U.S. states: Montana, South Dakota, New Jersey, and Vermont, and has been proposed in recent rulemaking in the State of Arkansas. Several other states are currently considering its adoption,” Dr. Nathan explained.

In 2023, 22 organizations representing public health, social justice, patient, consumer, and industry advocacy groups signed an open letter to regulators in the United States and around the world supporting universal adoption of the IICPS. If all states where cannabis is legal were to adopt this new standard moving forward, the result would be a significant time and cost savings in the long-run for companies who wish to expand across state lines. The symbol is clear, recognizable, and adheres to international interpretations based on color, shape, and other symbology factors. These factors were evaluated by a robust consumer research study to verify the effectiveness and intent of the symbol which was discussed in a webinar available on demand here.

To understand the impacts of many of the current symbols used in different states, written testimony submitted to the New York Office of Cannabis Management titled “A Symbolic Failure of Cannabis Regulation,” provides a colorful example. In it, Dr. Nathan states the following:

“The OCM symbol requires four-color printing, which is expensive. In a regulatory space intended to right the wrongs of the failed War on Drugs, the OCM symbol creates a barrier to entrepreneurs from historically oppressed communities who lack the capital to invest in costly packaging.

“The OCM symbol also violates numerous consensus standards, which are technical specifications issued by standards organizations like NIST, ASTM, and ISO. They are developed in an open environment to ensure public safety and promote best practices through collaboration by expert volunteers in the public and private sectors. Standards organizations have flourished since the 19th century, and their standards apply to everything from airplanes to zippers.”

Water Activity Controls

Dr. Jonathan DeVries, who provides food science services in regulatory and litigation matters, was the technical contact involved in developing the first two ASTM cannabis standards — developed to control water activity in cannabis flower that directly impacts both safety and quality of the product.

Dr. DeVries explained: “The first two methods adopted by ASTM committee D37 on Cannabis were ASTM D8196 Standard Practice for Determination of Water Activity (a_w) in Cannabis Flower and ASTM D8197 Standard Specification for Maintaining Acceptable Water Activity (a_w) Range (0.55 to 0.65) for Dry Cannabis Flower Intended for Human/Animal Use. During the early life stages of ASTM D37, cannabis growers, processors, and users stressed the importance of controlling the water activity of cannabis flower for safety and quality. All involved were generally aware that if the water activity was too high, microorganism growth, particularly mold, would damage the flowers rendering them unsafe (to say nothing of unpalatable). Similarly, cannabis flower that had a water activity that was too low (i.e the cannabis was too dry) could lead to dissatisfaction by the ultimate consumer because of handling losses due to fragility, loss of terpenes due to volatiles losses due to high burn temperatures during smoking, and unduly harsh characteristics of the smoke.” Both of those standards can be accessed through ASTM membership or purchased for a fee.

“Controlling the water activity to this range also is very logical during analysis, regulation, and commerce. Cannabis, properly dried and cured, then controlled to water activity 0.55 to 0.65 will exhibit very little variation in weight due to moisture change (controlling to a water activity range is typically more effective than controlling moisture directly) or loss or key volatiles that are part of the cannabis experience.

“As the technical contact for ASTM D8196 and D8197, I was always impressed with the ASTM processes, and of course, I was also impressed by the eagerness and willingness of those involved in providing safe, high-quality cannabis to be engaged in the process and share their extensive knowledge and experience to produce the optimum standard to meet the need.”

A Collaborative Effort

With more than 50 standards produced and published by the D37 Committee on Cannabis at ASTM, and another 50 more currently in development, there’s great opportunity to take the guesswork out of everything from Quality Management Systems, to Devices & Appliances, to Personnel Training, Assessment & Credentialing, and everything in between.

Stay tuned for the evolution of this article series, where we will explore more of these standards in order to understand their impact on ensuring consumer safety and streamlining what has been a chaotic patchwork of imperfect regulations and practices across the industry. By embracing standardized protocols and best practices, stakeholders can enhance transparency, build trust with consumers, and foster a more robust and sustainable cannabis market. Through collaboration and adherence to these evolving standards, we can pave the way towards a safer and more accountable cannabis and cannabinoid industry for all.

June 22, 2021

Unnecessary Obstacles for the Canadian Edibles Market

By Steven Burton

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The edible cannabis market in Canada is still green. Delayed by a year from the legalization of dried flower, the edibles and extracts market poses significant opportunities for manufacturers. Edibles and extracts typically have higher profit margins than dried flower (“value-added” products) and consumer demand appears to be high and rising. So, what is causing trouble for cannabis companies trying to break into edibles and extracts? Below are four observations on the market potential of edibles in Canada.

Canada’s Edibles Market: The Numbers

In 2020, Canada – the largest national market in the world for cannabis products – grew more than 60%, largely as a result of the introduction of new products introduced in late 2019, often called “Cannabis 2.0,” which allowed the sale of derivative products like edibles. Deloitte estimates that the Canadian market for edibles and alternative cannabis products is worth $2.7 billion, with about half of that amount taken up by edibles and the rest distributed amongst cannabis-infused beverages, topicals, concentrates, tinctures and capsules. More recently, BDSA forecasts the size of the Canadian edibles market to triple in size by 2025 to about 8% of the total cannabis dollar sales.

In December 2020, the Government of Canada reported that edibles made up 20% of total cannabis sales; Statistics Canada data shows that 41.4% of Canadians who reported using cannabis in 2020 consumed edibles. While sales have gone up and down over the course of the COVID-19 pandemic, there are clear indications that there is a substantial demand for edibles and extract products, which can be consumed more discreetly, with greater dosage precision and with fewer adverse effects (as opposed to smoking).

While sales of regulated edibles products continue to grow, edibles, extracts and topicals sales in Canada are facing a similar problem as dried flower sales: inventory growth is outpacing sales. Unsold stock sitting in inventory is growing at a dramatic pace, showing a clear lag in demand for these products on the legal market. How do we understand this contradiction?

1) Complex Regulatory Standards are a Major Barrier

Cannabis edibles compound the already existing problems around the conceptualization of cannabis products regulation. How should it work? Edibles can be considered in any of the following categories:

Cannabis as a pharmaceutical with medical application. Requires strict dosage and packaging requirements;
CBD as a nutraceutical with health benefits claimed. Requires specific nutraceutical regulations be followed;
Food product to be consumed. Must comply with food safety regulations around biological, chemical, physical hazards through a risk-based preventive control program. A full supply chain and ready-to-recall based system of regulatory standards need to be followed.

Incorporating elements from each of these three regulatory regimes into a single regulatory standards body is a confusing logistical and compliance challenge for both the regulators, and the producers and retailers of the product.

In mid-2019, the Government of Canada released the Good Production Practices Guide for Cannabis. This merged cannabis-specific regulations with food safety-specific regulations. Rigorous food safety requirements were combined with equally rigorous cannabis production and processing requirements, resulting in extremely laborious, detailed and specific regulations. These span everything from building design and maintenance, to pest control, to employee sanitation, to traceability – at all levels of the process. Navigating these regulations is a challenge, especially for many smaller producers who lack the necessary resources, like automation technology, to devote to understanding and tracking compliance.

2) Low Dosage Regulations Give an Edge to the Illicit Market

When edibles were legalized, THC dosage was capped at 10mg per package. For more experienced consumers, especially those who are dealing with chronic pain and other medical needs, this limit is far too low – and the unregulated market is more than able to fill this gap. One analyst from Brightfield pointed out that the dosage restriction, in combination with other regulations, will make it harder for the edibles market to grow in Canada.

It also makes the unregulated market almost impossible to beat. Barely more than half of cannabis consumers in Canada buy exclusively from government-licensed retailers, while 20% say that they will only buy unregulated products. According to a Deloitte report, 32% of legacy cannabis consumers said that unregulated products were better quality, and 21% reported that they preferred unlicensed products because there were more options available. Almost half of respondents also reported that quality was the biggest factor that would cause them to switch to regulated sources, and 28% said that higher THC content would prompt them to switch.

3) There is a Big Price Disparity between Legal and Illicit Edibles

As a result of dosage requirements and other factors, price per gram of regulated edible product is much higher than that of flower, unregulated edibles and edibles available through regulated medical distributors.

If you take the BC Cannabis Store’s price for Peach Mango Chews as an example: a 2pc package is $5.99. Since the dosage limits at 10mg per package, that’s the equivalent of $0.60/mg or $600/gram. A quick Google search reveals that an easily available edible from a medical cannabis distributor contains 300mg of THC and sells for $19.00, a price of $63.00/gram.

That means that not only is 10mg too low a dose for many users to achieve the result they were looking for, but the dosage restriction also makes the products less attractive from both a nutrition and cost standpoint. Deloitte reportsthat higher prices is the reason that 76% of long-time cannabis consumers continued to purchase from unregulated sources. The regulated industry as a whole is missing its legal market opportunity, where consumers prefer a lower price product with a greater range of dosage availability.

4) The Range of Products Available is Too Limited for Consumers

For most of 2020, chocolate edibles were the dominant product in this category in the Canadian market, garnering 65% of all edibles sales. But is this reflective of consumer wants? Despite a demand for other kinds of edibles like the ever-popular gummies, there are still only a few edible brands that offer the range of products consumers are asking for. According to research from Headset, there are 12 manufacturers in Canada making edibles but only two of them produce gummies. In comparison, 187 brands make gummies in the United States.

While some of this delay is likely due to the long licensing process in Canada and the newness of the market, there are other factors that make it challenging to bring a variety of products to market. The province of Quebec, Canada’s second-largest province, has banned the sale of edibles that resemble candies, confections, or desserts that could be attractive to children – giving yet another edge to unregulated sellers who can also capitalize on illegal marketing that copies from existing candy brands like Maynard’s.

When companies do want to introduce new products or advertise improvements to existing product lines, they are restricted by stringent requirements for packaging and marketing, making it harder to raise brand awareness for their products in both the legal and unregulated markets. Industry players are also complaining about government restrictions on consumers taste-testing products, which further compounds challenges of getting the right products to market.

In the meantime, illicit producers have also shown themselves to be savvy in their strategies to capture consumers. It is not uncommon to find illicit products packaged in extremely convincing counterfeit packaging complete with fake excise stamps. New consumers may assume the product they are purchasing is legal. Availability of delivery options for higher dosage, lower price illicit products is also widespread. All of this adds up to significant competition, even if it were easier to meet regulatory requirements.

Conclusion: Significant Room for Growth Remains Limited by Government Regulations

These four challenges are significant, but there are a number of opportunities that present themselves alongside them. A year and a half into the legalization of edibles, cannabis companies are getting a better picture of what Canadian consumers want and low dosages are proving to be desirable for Canadian consumers in some areas.

Some of the many infused products on the market today

In particular, sales of cannabinoid-infused beverages far outpaced other edibles categories last year, likely tied to the availability of these products in stores over the summer of 2020. BDSA’s research has shown that, in contrast with American consumers, the lower THC dosage for cannabis beverages is an advantage for Canadian consumers. Major alcohol brands like Molson Coors and Constellation Brands are investing heavily in this growing product area – though there the dosage limits also apply to how many products a consumer can buy at a time.

At the same time, the large quantity of unsold cannabis flower sitting in storage also poses an opportunity. While its quality as a smokeable product may have degraded, this biomass can be repurposed into extracts and edibles. Health Canada has also shown some responsiveness to industry needs when it shifted its stance to allow for Modified Atmosphere Packaging (MAP), which will help improve shelf life of products.

While strict regulatory obstacles remain, challenges will continue to outweigh opportunities and the illicit market will remain a strong player in the edibles market. As regulations become clearer and producers become more accustomed to navigating the legal space, barriers to entry into the regulated cannabis market and specifically the extracts and edibles market, will decrease. Meanwhile, those getting into the edibles market will do well to be wary of the challenges ahead.

September 21, 2020

2020 CQC Episode 3, Standards, Quality & Sustainability

By Cannabis Industry Journal Staff

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2020 Cannabis Quality Virtual Conference

Standards, Quality & Sustainability (Episode 3)

What’s In My Weed? A Panel on Cultivation

Rudy Ellenbogen, Whole Grow
Amy Lee Andrle, L’Eagle Services
Daniel Banks, LightShade
Ben Gelt, CCC
Karyemaitre Aliffe, Ethicannos

Ben Gelt, Board Chair of the CCC, will moderate a panel of leading cannabis and cannabis products producers to discuss supply chain, production and other difficulties in creating cannabis products and the challenges inherent in teaching consumers to be more discerning.

What’s in my Weed? A Panel on Derivative Goods

Jim Makoso, Lucid Lab group
Austin Stevenson, Vertosa
Ben Gelt CCC

Click here to watch the recording

July 2, 2020

ASI Global Launches Cannabis Safety & Quality Audit Standards

By Cannabis Industry Journal Staff

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According to a press release published July 1, ASI Global Standards announced the launch of their newest audit standard: the Cannabis Safety & Quality Scheme (CSQ). The scheme is built around ISO requirements and the Global Food Safety Initiative (GFSI) requirements.

With input from a number of stakeholders in the cannabis space, the CSQ scheme is designed for the cannabis industry and by the cannabis industry. Each standard was developed by industry professionals and stakeholders, like growers, manufacturers and processors, to meet market, consumer and regulatory requirements from seed-to-sale.

The CSQ scheme is built on four standards:

Growing and Cultivation of Cannabis Plants
Manufacturing and Extraction of Cannabis
Manufacturing and Infusion of Cannabis into Food & Beverage Products
Manufacturing of Cannabis Dietary Supplements

There is a public comment period in effect now, and those wishing to provide input have until July 31 to do so. If certification bodies or accreditation bodies want to find more information and get involved in the CSQ certification or accreditation process, they are encouraged to reach out via email at info@csqcertification.com.

May 30, 2019

Arizona To Implement Mandatory Lab Testing

By Aaron G. Biros

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Good news came to patients using medical cannabis in Arizona earlier this week: Lawmakers in Arizona unanimously passed SB1494 through the state’s House and Senate, the bill requiring mandatory lab testing for medical cannabis products. Arizona Governor Doug Ducey is expected to sign the bill and has ten days to do so.

When Governor Ducey signs the bill into law it will mark the first time since the state legalized medical cannabis in 2011 that a measure to protect patient safety via lab testing will be implemented. According to the bill, beginning November 1, 2020, all cannabis products shall be tested prior to sales “to determine unsafe levels of microbial contamination, heavy metals, pesticides, herbicides, fungicides, growth regulators and residual solvents and confirm the potency of the marijuana to be dispensed,” (Page 6, Section 36-2803).

The bill requires dispensaries to provide test results to patients immediately upon request. Dispensaries need to display a sign notifying patients of their right to see “certified independent third-party laboratory test results for marijuana and marijuana products for medical use,” according to the text of the bill (Page 7, Section 36-2803.01).“There will have to be some serious planning, but other states have achieved this and we can too.”

Under the new bill, the Arizona Department of Health Services will adopt rules to certify and regulate labs, establishing requirements like health and safety protocols, mandatory quality assurance program and standards, chain of custody and sampling policies, adequate records, accreditation, proficiency testing, among other requirements (Page 6-7, Section 36-2803).

Ryan Treacy, co-founder of the Arizona Cannabis Laboratory Association (ACLA) and CEO/Founder of C4 Laboratories, says this is a major turning point for Arizona’s cannabis industry. “We have been devoid of regulations with regard to testing the entirety of the program since it was legalized; This will be a significant change,” says Treacy. “Now patients can make sure they are getting a safe and clean product and getting exactly what they paid for.”

For those in the know when it comes to cannabis testing in the United States, the new requirements will look very similar to other states with testing requirements. One particularly unique aspect of the new program, however, is the establishment of a “Medical Marijuana Testing Advisory Council,” made up of stakeholders representing different interests in Arizona’s cannabis industry. Members of the council will include representatives from dispensaries, labs, cultivators, concentrate producers, edibles producers, as well as registered patients, caregivers, a representative from the Arizona Department of Public Safety, a licensed health care provider and “any other members deemed necessary by the director,” reads the text of the bill (page 16, Section 36-2821).

Ryan Tracy, co-founder of the ACLA and founder/CEO at C4 Labs.

“Other states like California have complained about detection limits, while Arizona is taking a unique approach with an advisory council with stakeholders in the cannabis industry,” says Treacy. “So that when the Department of Health Services promulgates rules, they are taking into account the challenges in the cannabis industry specifically. We have a chance to do this right and avoid pitfalls we’ve seen in other states.”

One problem worth mentioning for Arizona’s cannabis industry: Dispensaries have not been required to test products for patients since medical cannabis was legalized back in 2011. That means many producers could be very used to operating procedures that don’t account for lab testing. With mandatory lab testing, some producers may be behind the curve when it comes to mitigating contamination.

According to Treacy, this could disrupt the supply chain a little bit. “When testing becomes mandatory in November 2020, dispensaries will need a full panel of tests performed on their samples,” says Treacy. “With the entire market now required to complete a full panel in depth analysis on each product, product testing will become a more time-consuming stop in the supply chain. So companies will need to work that into their plan to meet regulation requirements to prevent a bottleneck and maintain patients’ access to their cannabis medicine.”

Arizona has a chance to prevent that type of bottleneck seen in states that implemented testing requirements, like California for example. “When you have a habitual history of not testing products, it can be very hard to change, which adds to Arizona’s challenges,” says Treacy. “We need to make sure this does not affect access for patients and the ability of the industry to continue to flourish and grow.”

While Treacy thinks the transition will be difficult for some, it’s absolutely necessary for Arizona’s patients to access clean and safe medicine. “There will have to be some serious planning, but other states have achieved this and we can too.”

August 8, 2018

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.

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.

February 7, 2018

Managing Cannabis Testing Lab Workflows using LIMS

By Dr. Susan Audino

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With the state led legalization of both adult recreational and medical cannabis, there is a need for comprehensive and reliable analytical testing to ensure consumer safety and drug potency. Cannabis-testing laboratories receive high volumes of test requests from cannabis cultivators for testing quantitative and qualitative aspects of the plant. The testing market is growing as more states bring in stricter enforcement policies on testing. As the number of testing labs grow, it is anticipated that the laboratories that are now servicing other markets, including high throughput contract labs, will cross into cannabis testing as regulations free up. As the volume of tests each lab performs increases, the need for laboratories to make effective use of time and resource management, such as ensuring accurate and quick results, reports, regulatory compliance, quality assurance and many other aspects of data management becomes vital in staying competitive.

Cannabis Testing Workflows

To be commercially competitive, testing labs offer a comprehensive range of testing services. These services are available for both the medical and recreational cannabis markets, including:

Detection and quantification of both acid and neutral forms of cannabinoids
Screening for pesticide levels
Monitoring water activity to indicate the possibility of microbiological contamination
Moisture content measurements
Terpene profiling
Residual solvents and heavy metal testing
Fungi, molds, mycotoxin testing and many more

Although the testing workflows differ for each test, here is a basic overview of the operations carried out in a cannabis-testing lab:

Cannabis samples are received.
The samples are processed using techniques such as grinding and homogenization. This may be followed by extraction, filtration and evaporation.
A few samples will be isolated and concentrated by dissolving in solvents, while others may be derivatized using HPLC or GC reagents
The processed samples are then subjected to chromatographic separation using techniques such as HPLC, UHPLC, GC and GC-MS.
The separated components are then analyzed and identified for qualitative and quantitative analysis based on specialized standards and certified reference materials.
The quantified analytical data will be exported from the instruments and compiled with the corresponding sample data.
The test results are organized and reviewed by the lab personnel.
The finalized test results are reported in a compliant format and released to the client.

In order to ensure that cannabis testing laboratories function reliably, they are obliged to follow and execute certain organizational and regulatory protocols throughout the testing process. These involve critical factors that determine the accuracy of testing services of a laboratory.

Factors Critical to a Cannabis Testing Laboratory

Accreditations & Regulatory Compliance: Cannabis testing laboratories are subject to regulatory compliance requirements, accreditation standards, laboratory practices and policies at the state level. A standard that most cannabis testing labs comply to is ISO 17025, which sets the requirements of quality standards in testing laboratories. Accreditation to this standard represents the determination of competence by an independent third party referred to as the “Accreditation Body”. Accreditation ensures that laboratories are adhering to their methods. These testing facilities have mandatory participation in proficiency tests regularly in order to maintain accreditation.
Quality Assurance, Standards & Proficiency Testing: Quality assurance is in part achieved by implementing standard test methods that have been thoroughly validated. When standard methods are not available, the laboratory must validate their own methods. In addition to using valid and appropriate methods, accredited laboratories are also required to participate in appropriate and commercially available Proficiency Test Program or Inter-Laboratory Comparison Study. Both PT and ILC Programs provide laboratories with some measure of their analytic performance and compare that performance with other participating laboratories.
CloudLIMS Cannabis Testing LIMS: Multi-analyte Configuration for Cannabis Testing Services
Real-time Collaboration: Testing facilities generate metadata such as data derived from cannabis samples and infused products. The testing status and test results are best served for compliance and accessibility when integrated and stored on a centralized platform. This helps in timely data sharing and facilitates informed decision making, effective cooperation and relationships between cannabis testing facilities and growers. This platform is imperative for laboratories that have grown to high volume throughput where opportunities for errors exist. By matching test results to samples, this platform ensures consistent sample tracking and traceability. Finally, the platform is designed to provide immediate, real-time reporting to individual state or other regulatory bodies.
Personnel Management: Skilled scientific staff in cannabis-testing laboratories are required to oversee testing activities. Staff should have experience in analytical chromatography instruments such as HPLC and GC-MS. Since samples are often used for multi-analytes such as terpenes, cannabinoids, pesticides etc., the process often involves transferring samples and tests from one person to another within the testing facility. A chain of custody (CoC) is required to ensure traceability and ‘ownership’ for each person involved in the workflow.

LIMS for Laboratory Automation

Gathering, organizing and controlling laboratory-testing data can be time-consuming, labor-intensive and challenging for cannabis testing laboratories. Using spreadsheets and paper methods for this purpose is error-prone, makes data retrieval difficult and does not allow laboratories to easily adhere to regulatory guidelines. Manual systems are cumbersome, costly and lack efficiency. One way to meet this challenge is to switch to automated solutions that eliminate many of the mundane tasks that utilize valuable human resources.^. Laboratory automation transforms the data management processes and as a result, improves the quality of services and provides faster turnaround time with significant cost savings. Automating the data management protocol will improve the quality of accountability, improve technical efficiency, and improve fiscal resources.

Real Time Test Status in CloudLIMS

A Laboratory Information Management System (LIMS) is a software tool for testing labs that aids efficient data management. A LIMS organizes, manages and communicates all laboratory test data and related information, such as sample and associated metadata, tests, Standard Operating Procedures (SOPs), test reports, and invoices. It also enables fully automated data exchange between instruments such as HPLCs, GC-FIDs, etc. to one consolidated location, thereby reducing transcription errors.

How LIMS Helps Cannabis Testing Labs

LIMS are much more capable than spreadsheets and paper-based tools for streamlining the analytical and operational lab activities and enhances the productivity and quality by eliminating manual data entry. Cloud-enabled LIMS systems such as CloudLIMS are often low in the total cost of acquisition, do not require IT staff and are scalable to help meet the ever changing business and regulatory compliance needs. Some of the key benefits of LIMS for automating a cannabis-testing laboratory are illustrated below [Table 1]:

Key Functionality	Benefit
Barcode label designing and printing	Enables proper labelling of samples and inventory Follows GLP guidelines
Instant data capture by scanning barcodes	Facilitates quick client registration and sample access
360⁰ data traceability	Saves time and resources for locating samples and other records
Inventory and order management	Supports proactive planning/budgeting and real time accuracy
Custodian management	Promotes overall laboratory organization by assigning custodians for samples and tests Maintains the Chain-of-custody (CoC)
Test management	Accommodates pre-loaded test protocols to quickly assign tests for incoming samples
Accounting for sample and inventory quantity	Automatically deducts sample and inventory quantities when consumed in tests
Package & shipment management	Manages incoming samples and samples that have been subcontracted to other laboratories
Electronic data import	Electronically imports test results and metadata from integrated instruments Eliminates manual typographical errors
Report management	Generates accurate, customizable, meaningful and test reports for clients Allows user to include signatures and additional sections for professional use
21 CFR Part 11 compliant	Authenticates laboratory activities with electronic signatures
ISO 17025 accreditation	Provides traceable documentary evidence required to achieve ISO 17025 accreditation
Audit trail capabilities	Adheres to regulatory standards by recording comprehensive audit logs for laboratory activities along with the date and time stamp
Centralized data management	Stores all the data in a single, secure database facilitating quick data retrieval
Workflow management	Promotes better data management and resource allocation
High-configurability	Enables modification of screens using graphical configuration tools to mirror testing workflows
State compliance systems	Integrates with state-required compliance reporting systems and communicates using API
Adheres to regulatory compliance	Creates Certificates of Analysis (CoA) to prove regulatory compliance for each batch as well as batch-by-batch variance analysis and other reports as needed.
Data security & confidentiality	Masks sensitive data from unauthorized user access Cloud-based LIMS encrypts data at rest and in-transit while transmission between the client and the server
Global accessibility	Cloud-based LIMS provides real-time access to laboratory data from anytime anywhere
Real-time collaboration	Cloud-based LIMS enhances real-time communication within a laboratory, between a laboratory and its clients, and across a global organization with multiple sites

Table 1. Key functionality and benefits of LIMS for cannabis testing laboratories

Upon mapping the present day challenges faced by cannabis testing laboratories, adopting laboratory automation solutions becomes imperative. Cloud-based LIMS becomes a valuable tool for laboratory data management in cannabis testing laboratories. In addition to reducing manual workloads, and efficient resource management, it helps labs focus on productive lab operations while achieving compliance and regulatory goals with ease.

For more information on this, check out a webinar here: Webinar: How to Meet Cannabis Testing Standards and Regulatory Requirements with LIMS by Stephen Goldman, laboratory director at the State of Colorado certified Cannabis testing facility, PhytaTech.

June 12, 2017

ASTM International and American Herbal Products Association Announce Partnership

By Aaron G. Biros

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According to a press release sent out on June 8^th, ASTM International and the American Herbal Products Association (AHPA) announced a memorandum of understanding to collaborate on cannabis standards. The press release says that ASTM International will coordinate the work to develop the standards with all stakeholders involved and AHPA will make technical contributions and regulatory recommendations. AHPA will get recognized for their contributions per the license agreement. ASTM International is a standards development organization that develops voluntary consensus-based standards for industries.

This announcement precedes the first committee meetings for the development of cannabis standards, which began Sunday, June 11th and continue through June 12th. That committee group has now grown to roughly 200 members, including businesses, laboratories, associations, governments and more. “Many of our stakeholders – manufacturers, dispensaries, labs, consultants, and others – have laid the groundwork for guidance on the safe use and legal commerce of cannabis,” says Jane Wilson, director of program development at AHPA. “We are thrilled to now be contributing to standards development through one of the world’s top standards organizations.”

Ralph Paroli, Ph.D., the committee’s new chairman and the director of R&D in measurement science and standards at the National Research Council of Canada, says AHPA is a key organization in providing expertise on cannabis standards. “AHPA’s support for this new committee will help expedite international standards development, identify gaps, prevent duplicative efforts, and more,” says Paroli. The cannabis standards committee, officially designated D37, was formed on March 1^st.

May 2, 2017

California Releases Draft Medical Cannabis Regulations

By Aaron G. Biros

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Last week, Governor Brown’s Administration released a set of proposed rules for the medical cannabis, attempting to provide some oversight to the once unregulated market. In 2015, the governor signed three bills into law that established a regulatory framework via the Medical Cannabis Regulation and Safety Act. That legislation set up the Bureau of Medical Cannabis Regulation inside the Department of Consumer Affairs as the overseeing regulatory agency.

According to the press release, the proposed regulations for manufacturing and cultivation have also been published. “The proposed licensing regulations for medical cannabis are the result of countless hours of research, stakeholder outreach, informational sessions and pre-regulatory meetings all across the state,” says Lori Ajax, chief of the Bureau of Medical Cannabis Regulation. “And while we have done quite a bit of work and heard from thousands of people, there is still so much more to do. In order to make our program successful we still need your feedback.”

According to their website, the legislation divides responsibility for licensing businesses between three regulatory bodies: The CA Department of Food and Agriculture the CA Department of Public Health and the Bureau of Medical Cannabis Regulation, which will be the leading body in charge of licensing. The proposed regulations are not set in stone, but give us an important glimpse into how the state hopes to regulate the market.

Among the proposed rules are a number of regulatory compliance nuances expected to raise prices, but provide extra measures to protect consumer safety. According to the SF Gate, regulators expect prices could climb $524 per pound. But with that price jump comes a lot of regulations that other states have so far successfully implemented. The laboratory testing and traceability stipulations are presumably designed to safeguard public health, preventing things like black market diversion and off-label pesticide use.

In addition to the medical regulations, the proposed manufacturing regulations set some notable requirements. Those rules are set by the Office of Manufactured Cannabis Safety, established in the Center for Environmental Health of the California Department of Public Health (CDPH) after the 2015 legislation was signed into law. Good Manufacturing Practices, food product standards, operational and labeling requirements are included in the provisions, along with a list of licensing tiers, application requirements and fees. They have a handy summary of the proposed regulations for those looking for the key highlights.

Omar Figueroa, an attorney with a cannabis law practice in California, says his clients in the industry are preparing to suggest changes to the proposed regulations and possibly legal challenges. “They are looking at this as overregulation by people that are not in the cannabis industry,” says Figueroa. “These are outsiders with a limited knowledge base creating somewhat uninformed regulations.” He says a good example of this is the potency limit on infused products. “They make perfect sense for [the recreational market] but for the medical market it is simply unacceptable. Patients develop a tolerance to THC and would have to increase their caloric intake and buy more infused products if this proposed regulation becomes final.” He says there are a number of regulations that seem kind of arbitrary. “Like prohibiting cannabis-infused caffeine products; there doesn’t seem to be a necessity in the rulemaking for this,” says Figueroa. “A lot of these regulations are going to be susceptible to challenges because California requires regulations to be necessary and alternatives to be considered.”

Although the lab testing regulations won’t be published for another few days, Figueroa expects them to be a huge disruptor for the market. “Most labs in the state are not ISO 17025-accredited, which means many labs might not be able to issue certificates of analysis when the regulations get enforced,” says Figueroa. He says it is safe to say California regulators are looking at other jurisdictions, like Colorado and Oregon for example, in crafting these rules, but we can expect a sea change in these regulations before they get enforced.

Manufacturers will be required to use a cannabis product symbol with a ‘THC!’ marking on their labels. There is also a 100-milligrams-per-package limit for THC in infused products, which is similar to rules we saw Colorado and Oregon roll out during a preliminary period of legal recreational cannabis.

For those looking to get involved in the regulatory process, there is a 45-day comment period on the proposed rules.

March 2, 2017

ASTM International Launches Cannabis Committee

By Aaron G. Biros

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According to a press release published March 1^st, ASTM International formed a committee focusing on “creating technical standards and guidance materials for cannabis and its products and processes.” ASTM, founded in 1898, as the American Section of the International Association for Testing Materials, predates other standards organizations such as IEC (1906), ANSI (1918) and ISO (1947). ASTM International is a non-profit organization devoted to the development of international standards. For more than a century, ASTM has served as a leading venue for consumers, industry and regulators to work collaboratively under a balanced and consensus–based process to craft voluntary consensus standards.

ASTM International meets the World Trade Organization (WTO) principles for developing international standards, and maintains the attributes outlined in the National Technology Transfer and Advancement Act (NTTAA) for a voluntary consensus standards development organization. ASTM International is known throughout a variety of industries for creating voluntary consensus standards for products, systems, services and materials. ASTM standards are used globally in research and development, product testing, quality systems, commercial transactions, and more.

On January 18^th, 2017, the American Public Health Association hosted thirteen industry stakeholders representing state laboratories, standards developers, research institution, academia, cultivation centers, auditors and software compliance providers, according to Lezli Engelking, founder of the Foundation of Cannabis Unified Standards (FOCUS), who is involved and familiar with the process. The planning meeting discussions included a summary of where the request was initiated, why a standards activity was necessary and the results of ASTM’s exploratory efforts. At the conclusion of the planning meeting, it was decided by vote, that ASTM should move forward with the activity.

On February 28^th, 2017, roughly 60 stakeholders and cannabis industry representatives met at ASTM International’s headquarters in Conshohocken, Pennsylvania. The volunteer committee on cannabis, designated D37 by ASTM, is a result of inquiries flooding the company regarding cannabis since 2015, states the press release.

The committee will focus on six technical areas, forming subcommittees:

Indoor and outdoor horticulture and agriculture,
Quality management systems,
Laboratory,
Processing and handling,
Security and transportation, and
Personnel training, assessment, and credentialing.

Dr. Ralph Paroli, immediate past chairman of the board and director of R&D in measurement science and standards at the National Research Council of Canada, was voted to serve as the committee’s first chairman. “With its decades of experience in industries such as pharmaceuticals, medical devices, packaging, agriculture, pesticides, and more, ASTM International is the perfect place for standards development for the cannabis industry,” says Paroli.

Pending ASTM International board of directors’ approval (anticipated late April 2017), a shift of standards development efforts has been made from FOCUS to the ASTM International technical committee D37 on cannabis and its products and processes.

“FOCUS could not be more pleased by ASTM’s decision to further the development of internationally harmonized cannabis standards,” says Engelking. “This is desperately needed, and an enormous step in the right direction of legitimizing the cannabis industry. We are thrilled FOCUS standards will be included, and honored to be a part of this exciting process.” During this transition period, interested stakeholders can get directly involved through the FOCUS website and then follow directions provided by FOCUS.

According to Engelking, third-party, cannabis-specific certifications for cultivation, retail, extraction, infused products and laboratories are provided by FOCUS for cannabis businesses committed to providing safe, consistent and quality products. FOCUS certification helps businesses decrease liability and risks, maximize efficiency, reduce costs and differentiate their brands.

“FOCUS encourage all stakeholders to participate in this important process,” says Engelking. “ASTM has an incredible standards development system in place that allows for many different levels of participation.” During 2017, ASTM is offering free temporary memberships. After 2017, stakeholders will need to join as a participating member.