Tag Archives: ASTM

Don’t Reinvent The Wheel: A Tour of ASTM Standards for Cannabis and Hemp – Part 2

By David Vaillencourt, Bethany Moore
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In our previous article, we delved into the foundational ASTM International standards that are shaping the cannabis and hemp industries. We explored the first true universal symbol for cannabis, water activity controls, and Hazard Analysis and Critical Control Points (HACCP) standards. As we continue this journey, we turn our attention to four additional ASTM International standards that are pivotal for ensuring public health and safety and streamlining operations for cannabis and hemp operators. These include standards on conducting a product recall, Corrective and Preventive Action (CAPA), how to establish a Quality Management System (QMS), and management responsibilities in an effective cannabis business. In this article, we speak with experts who contributed a significant amount of time and knowledge in shaping these standards, including Trevor Morones of Control Point Consulting, Cary Black of CK Black Group, and Steven Cooper of Quality Initiatives LLC.

Recall/Removal Procedures: Ensuring Swift and Safe Actions

When seven people died from taking unknowingly contaminated TYLENOLⓇ in 1982, it was the swift actions of Johnson & Johnson in initiating a costly but prudent recall that salvaged their reputation. Since then, numerous companies in the food, beverage, and pharmaceutical industries have been subjected to recalls. The reality is, that even the most robust processes are susceptible to human error or unforeseen circumstances. And in that worst case scenario, having a tested recall plan in place is critical to be able to respond efficiently, minimize harm to consumers, and maintain brand trust. The ASTM standard for recall/removal procedures provides just that; a structured approach to swiftly and effectively remove potentially harmful products from the market. Imagine a cannabis producer discovers that a batch of edibles has pieces of metal shavings in it. With this standard implemented, this company would have the ability to immediately initiate a recall, contact the distributors and retailers that received the product to remove the product from shelves and notify consumers. Within hours, the potentially dangerous product is no longer available, and public safety is safeguarded. This swift action not only protects consumers but also helps maintain the company’s reputation for quality and safety.

Cary Black, ASTM Fellow, ASQ CQE, PCQI, and Principal Consultant for CK Black Group, Inc., and Technical Contact for the ASTM standard ‘D8220-20 Standard Guide for Conducting Recall/Removal Procedures for Products in the Cannabis Industry’ said, “Effective recall procedures provide the final fail-safe for consumer safety. As in the food industries, the supplement industries, the pharmaceutical industries, cannabis industry must hold the same capability to effectively, quickly, and efficiently recall products that have been determined to be a risk for consumers. For an efficient recall program, there is a vetted series of protocols that have been employed to quickly recall adulterated products. From forming the recall team and maintaining clear and accurate traceability records from your raw materials, your inventory, and shipping to your customers; all these elements come together to create a seamless series of steps to initiate an effective recall when needed.

For an effective recall program, not only should the proper elements be in place for a recall, additionally there should also be provisions for conducting mock recalls to allow the recall team to practice the efficacy of their record keeping and procedural implementation.

Any supplier of cannabis products for human or animal consumption is required by all authorities having jurisdiction to a program in place and the ability to quickly recall adulterated products.”

CAPA (Corrective and Preventive Action): Proactive Problem Solving

As we stated above, even the most robust processes are susceptible to human error or unforeseen circumstances. Wouldn’t it be nice if there was a way to prevent those mistakes from ever happening again? Enter Corrective and Preventive Action (CAPA). A foundational tried and true component of every quality management system is that it is designed to identify the true root cause of a mistake, implement a corrective action, and verify the effectiveness of the corrective action to prevent the recurrence of such a mistake. Even better, CAPA is a tool to prevent the occurrence of problems before they occur in the first place. The ASTM CAPA standard guides operators in systematically addressing problems to avoid recurrence, leading to streamlined operations and enhancements to overall product quality and consistency. In the example above where the cannabis edibles producer has identified contaminated products and recalled the products from shelves, the next natural step would be to become proactive about ensuring that it does not occur again. That’s one of many examples where the CAPA standard steps in and provides a valuable solution.

Trevor Morones, Control Point founder and Chair of ASTM’s Cannabis Subcommittee on Personnel Training, Assessment, Credentialing (D37.06), who was involved in developing the ASTM CAPA standard D8299, said, “Implementing effective corrective action processes within an organization yields substantial benefits. Proactively preventing recurring incidents is key, but the commitment to continuous improvement is equally crucial. Open and effective communication with all involved parties is not just essential; it’s a way of showing that everyone’s input is valued and included in identifying and implementing the best solutions. Moreover, embracing ASTM standards can greatly enhance an organization’s competitive edge in the marketplace.”

Kara Lavaux, CP-FS, CQA, Compliance Consultant for Allay Consulting, said, “To build on what Trevor said, a CAPA plan is a hard-working component of a quality management system. CAPA works for times when you need to react to an issue, and for times when you have the foresight to prevent a future issue. The key to an effective CAPA program is learning to shift the focus away from the symptom of the issue and instead focus attention and action on the root of the issue. It’s the root of the issue that needs a corrective action, which will result in both the correction of the symptoms and the prevention of the issue in the future. In the example above of distributed edibles with mold contamination, the issue (risk to the public) was “fixed” by completing a quick recall of the products. But this correction does not prevent the issue from occurring again in the future. If we do not put control measures in place to prevent the mold on the edibles, we could continue distributing moldy edibles and will continue conducting reactionary recalls to protect consumers. Opening a CAPA and doing a deep dive into what caused the mold will reveal the root issue that needs to have a corrective action. Is it a water activity issue with the recipe, or perhaps a handling issue during packaging, or perhaps a storage issue at the dispensary? The CAPA investigation will reveal the root cause. Fixing the root cause leads to continual improvement of the process and prevents the issue from recurring.”

Establishing a QMS for Consumer Products: Foundation of Quality

In the 1980s, manufacturers discovered the value of implementing a Quality Management System (QMS) to provide a high level of confidence both internally and to their customers that their products would deliver on the quality and consistency that they were expected to meet. Forty years later, being certified to having an effective quality management system is one of the most basic requirements of companies engaging in global trade. The ASTM standard for establishing a QMS for consumer products lays the groundwork for comprehensive quality management in the cannabis and hemp industries. For example, when a company is launching a new line of products, a QMS provides the structure to develop and document the process for everything from ingredient sourcing to final product testing. This ensures that when this production line is scaled and commercialized, the process will be validated to provide the confidence needed that consumers will receive a safe and consistent product time and time again. Additionally, companies with a QMS will more easily be able to adapt to regulatory changes and stay in line with compliance requirements.

Cary Black, author of the ASTM standard, ‘D8222-21a Standard Guide for Establishing a Quality Management System (QMS) for Consumer Use of Cannabis/Hemp Products’ said, “Having a functional QMS is typically the first set of requirements for governing the manufacture and distribution of products. For products consumed by humans or animals a functional QMS sets the base for practices aligned with GMP. For most authorities having jurisdiction, relative to products that are consumed by humans or animals, a QMS supporting GMP compliance is required.

A functional QMS additionally provides the platform for a system that not only drives regulatory compliance, but also adjusts to and supports continuous improvement efforts, provides systems for manufacturing and distribution, and can foster increased productivity, improve efficiencies, incorporate risk management approaches, and ultimately ensure the safety of the products to its consumers.

The more participants within the Cannabis industry embrace the value of implementing a functional QMS, the more sustainable their manufacturing and product lines will become and the closer they will be to a risk management approach that aligns with most GMP requirements for cannabis products consumed by humans or animals.”

Management Responsibilities in Managing a QMS: Leadership and Accountability

You don’t have to be a retired Navy SEAL to understand the significant influence that leadership has when it comes to building a successful organization. Effective quality management requires strong leadership and clear responsibilities. The ASTM standard for management responsibilities in managing a QMS (D8398) outlines the roles and duties of management in developing, implementing, and maintaining an effective quality system. The symbiotic relationship between leadership and employees is crucial to fostering a culture of excellence. Ensuring that management is allocating the appropriate resources, providing adequate training, and regularly reviewing the system is paramount for employees to feel supported and confident in their understanding of how their roles are part of the bigger picture of maintaining high standards. And when employees have clear roles and responsibilities with the requisite support, businesses succeed. Research from Gallup has shown that companies with engaged employees benefit from 40% less quality defects and are more than 20% profitable compared to peer organizations with low employee engagement.

Steven Cooper, President of Quality Initiatives LLC, and author of this standard, emphasized the importance of leadership demonstrating support of quality and safety and how it can impact the entire company in the long term. “When I was involved in writing this standard, my main focus was to target the CEO or other top management of a company, or someone who is looking to start a company. My standard is intended for these types of people to help them simply understand some of the basic requirements to do things right and to ensure they get off on the right foot toward product quality. Most of the other standards written for GMP are rather long documents intended for a quality professional, and my document is specifically targeting someone who needs to capture the basic top-line requirements without spending a lot of time trying to understand an extensive detailed GMP requirements document. Ultimately, it’s easy for management to give lip service in saying “quality is important” but how do they get serious? How does an employee do their job to feed the need to satisfy quality requirements? What role does the employee have in the quality management system? And that’s where management needs to ensure a good understanding of the employees, which is achieved by training and follow through, but also by setting an example. And by that, I mean that the first time there is a quality problem, what does management do? Do they ignore it? Do they say it costs too much to fix? Are they serious? And that message really has to be very carefully delivered ot the employees so they are not only aware of the need for quality, but they have an appreciation of the importance. That can only be delivered by management walking the walk, not just talking the talk. 

As an example, a company can say they care about quality. They can hang posters and have meetings, but in one incident I observed, it wasn’t until there was a safety incident where someone could have been seriously injured or worse, and a mistake was made, at that moment, the reaction by management was critical. Did they just have a meeting to talk about it? Nope. The VP of Operations shut down the facility for three days, which is difficult to do when the company is demanding product, and customer orders are waiting to be filled, money on the line, etc, but when that decision was made, it sent a very serious message to all of the employees in the factory about the importance of quality. After that, the respect and appreciation for safety rose to a much higher level, and probably remained there for many years, all because of that one incident and the way management reacted. They walked the walk, not just talked the talk. They didn’t just take shortcuts to get the product out the door. 

Shaping The Industry

As the cannabis and hemp industries continue to evolve, the marketplace is going to get more competitive and only those with a high bar of quality, and the data to prove it, wil succeed.These four ASTM standards—recall/removal procedures, CAPA, establishing a QMS, and management responsibilities in QMS—are invaluable resources for operators to implement to not only maintain regulatory compliance, but ensure a future of success. By adhering to these standards, operators not only safeguard public health but also streamline their processes and build a stronger, more trustworthy industry.

In our next article, we will explore additional ASTM standards that are paving the way for innovation and excellence in the cannabis and hemp sectors. Stay tuned as we continue to highlight the standards that are shaping the future of this dynamic industry.

Call to Action: If you are a professional in the cannabis and hemp industries, consider joining ASTM and contributing to the development of these crucial standards. Together, we can build a safer and more efficient industry.

For more information on ASTM standards and how they can benefit your operations, visit https://www.astm.org/get-involved/membership.html.

IICPS universal symbol

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

By Bethany Moore, David Vaillencourt
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IICPS universal symbol

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.

IICPS universal symbol
Above: International Intoxicating Cannabinoid Product Symbol (IICPS)

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 (aw) in Cannabis Flower and ASTM D8197 Standard Specification for Maintaining Acceptable Water Activity (aw) 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.

ASTM Launches New Labeling Standard

By Cannabis Industry Journal Staff
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ASTM International has announced the approval of a new standard in development that could have potentially wide-reaching influence on the cannabis industry throughout the world. ASTM’s cannabis committee (D37) has approved the new standard (D8449) for development that aims to develop internationally aligned label specifications for all products containing cannabinoids.

According to the press release, The new labeling standard is the first of its kind, attempting to harmonize regulations throughout the cannabis industry with universally recognized labels that could be adopted by regulators anywhere in the world. ASTM member Darwin Millard has spearheaded the development of this new standard and believes it will have countless practical applications.

“Having the same information presented in the same manner across jurisdictions means consumers of products containing cannabinoids will have consistent information conveyed to them in a way they are familiar with,” says Millard. “This ensures consumers have the information they need to make an informed purchase decision, and will ultimately lead to increased consumer safety and confidence.”

ASTM International is a nonprofit, voluntary consensus-based standards development group. They are inviting feedback and input as they refine the standard and work on presenting it to the international cannabis community. “We welcome regulators, producers, and consumers from around the world to give us feedback,” says Millard. “This is intended to be a living document to remain relevant throughout this ever-changing landscape.”

ASTM Develops Two New Cannabis Standards

By Cannabis Industry Journal Staff
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According to a press release emailed this week, ASTM International’s subcommittee focused on cannabis, D37, is in the midst of developing two new standards surrounding cannabis safety and education.

One standard, WK84667, is designed to “help document engineering controls for air filtration and person protective equipment (PPE) in cannabis processing facilities,” says ASTM member Trevor Morones. The premise of this standard appears to be employee safety; with proper, standardized air filtration and PPE, the standard will help companies keep their workers safe and prevent inhalation of potentially harmful particles, like cannabis dust, stalk fiber, florescence and crystalized dust. “We are working to develop a robust community of cannabis professionals who can share their experiences in workplace and personnel safety,” says Morones.

The other proposed standard, WK84589, seeks to develop a uniform metric for “determining the intoxication level of a cannabinoid.” Initially focusing on delta9-THC, the standard will help raise awareness and promote public health and safety by informing consumers how intoxicating a cannabis product is for the average adult.

ASTM Pamela Epstein says this standard will hopefully develop a form of measurement akin to ABV in alcoholic drinks, allowing consumers to see how potent a certain cannabis product is. “Beyond providing consumers with a complete assessment of a product’s total intoxicating/impairing effects, the proposed standard may provide regulators with a methodology to meaningfully account for public health and safety,” says Epstein. “The specification can unify consumer awareness and can be used across all product types and jurisdictions.”

The ASTM D37 committee is working on a number of other standards related to these and they invite anyone interested to share their feedback.

ASTM Debuts New Standards for Cannabis

By Cannabis Industry Journal Staff
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Earlier this month, ASTM International announced that the D37 cannabis committee has approved four new standards for the cannabis industry. Just a few days ago, the same organization announced the development of a new standard that will be published soon.

According to a press release, the four new standards that are already approved will help those working in the cannabis space, as well as regulators and consumers. The four new approved standards are as follows:

  • D8375: This standard provides a method to establish cannabinoid content in cannabis and hemp samples. ASTM member Garnet McRae says, “the standard will help ensure products are labeled properly in jurisdictions where they are legally produced and sold.”
  • D8399: This standard “will aid laboratories in analyzing cannabis and hemp samples to establish pesticide concentration levels – or lack thereof – to ensure products meet regulatory requirements within appropriate jurisdictions,” reads the press release.
  • D8442: This standard aids stakeholders in the cannabis supply chain with quality control measurements. It provides a method for testing terpenes and cannabinoid levels using gas chromatography.
  • D8469: This one provides a new metals testing method for cannabis using inductively coupled plasma mass spectrometry (ICP-MS).

David Vaillencourt will be discussing standards and more at the Cannabis Quality Conference on October 17. The fifth standard that ASTM International announced this week is D8439. This one is designed “to support sound and reproducible research” by providing specifications for medicinal-use cannabis flower. ASTM member David Vaillencourt says it will help establish consistent testing for safety and quality. “With a fragmented cannabis industry marketplace, there is no common set of requirements around reporting cannabinoids and terpenes, which are the primary constituents that are linked to therapeutic benefits,” says Vaillencourt. “This lack of consistency harms public health and prevents evaluation of product safety and efficacy across jurisdictions. This standard provides a solution to this problem.”

Ask the Experts: Ensuring the Validity of Cannabis Lab Testing

By Cannabis Industry Journal Staff
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Cannabis testing laboratories are one of the major players in the industry for protecting public health. Ensuring that laboratory test results are reliable and valid requires a multipronged approach involving method validation, proficiency testing and performing frequent reviews of equipment and processes.

Cannabis testing laboratories often use a variety of different methods to conduct proficiency testing. Laboratories can either participate in programs run by ISO/IEC 17043-accedited proficiency testing providers or through intralaboratory comparison. Comparing different instruments, methods, technologies against pre-defined criteria is a must when validating methods for a specific type of test and ensuring the competence of the laboratory.

Beyond proficiency testing, there are a number of other stopgaps at a laboratory’s disposal for ensuring valid results, like using accredited certified reference materials, performing checks on measuring equipment frequently, reviewing reported results and retesting retained items. All of that and more is outlined in the ISO/IEC 17025:2017 standard, section 7.7.

labsphoto
What good is a test result if you cannot attest to its validity?

There’s a lot that goes into making sure laboratories provide valid results, much of which is detailed in the accreditation process. For more information, we sit down with Keith Klemm, senior accreditation manager for ANSI National Accreditation Board to learn about laboratory accreditation, method validation and other certifications and credentialing available in the cannabis industry.

Q: Why is method validation important for cannabis test methods? 

Keith Klemm: Because cannabis production, testing, and sales is regulated by each individual state, there are very few standard methods for testing cannabis and cannabis-derived products. Non-standard methods or methods developed by the laboratory must be validated to ensure the methods are fit for their intended purpose. What good is a test result if you cannot attest to its validity? There would be no confidence that the results are accurate. Additionally, while organizations such as ISO, AOAC and ASTM are developing standard methods for use in the laboratory, the wide range of products and matrices being tested require modifications to standard methods. Standard methods used outside their intended scope must also be validated, again to ensure the method remains fit for the intended purpose.

Q: We’re pretty familiar with laboratory accreditation. What other accreditations are available in the cannabis industry?

Klemm: Accreditation programs are available for product certification and personnel credentialing, in addition to laboratory accreditation. ANAB’s product certification program was launched in 2020 and is based on the requirements of ISO/IEC 17065. The program combines the requirements of this standard with specific scheme requirements to attest to the competency of certification bodies who then certify products within the scheme. Two schemes are in development specific to the cannabis industry: Cannabis Safety and Quality (CSQ) and PurityIQ. For personnel credentialing, a new Cannabis Certificate Accreditation Program (C-CAP) was developed and is based on ASTM D8403, Standard Practice for Certificate Programs within the Cannabis and Hemp Industries. It also includes any additional state Responsible Vendor Training requirements.

Q: What are the steps to becoming an accredited cannabis testing laboratory, product certification body, or C-CAP organization?

Klemm: The process begins with a request for quote. The organization prepares for the initial assessment by implementing the requirements of the applicable standards, regulatory requirements, and scheme requirements. ANAB believes in a partnership approach to accreditation with a focus on customer needs while ensuring accreditation requirements are met. Once the organization is ready, an initial document review is performed. The accreditation assessment is then performed on-site by technically skilled and knowledgeable assessors. If any nonconformities are encountered, the organization provides a response with cause and corrective actions. Once all nonconformities are resolved and technical review is completed, a scope of accreditation and certificate are provided to the organization. The technical review may vary depending on the accreditation that is being sought, but the general process of accreditation is the same. After accreditation is achieved, the organization moves into a cycle of surveillance and reassessment as defined by the accreditation program and any scheme requirements.

About Keith Klemm

Keith Klemm is a graduate of Manchester University with a B.S. in Biology.  Keith is an experience laboratory director and operations manager with 30 years’ experience in the laboratory environment and has worked as a senior accreditation manager for ANSI National Accreditation Board for the past five years.

Keith’s areas of expertise include:

  • Microbiological assays for food, medical device, and environmental test matrixes.
  • Environmental chemistry of water and wastewater.
  • Biocompatibility testing of medical devices.
  • ISO/IEC 17025:2017
  • AOAC International – guidelines for food laboratories program requirements
  • 21 CFR Part 58, GLP program requirements
  • EPA NLLAP program requirements
  • AAFCO program requirements
  • FDA ASCA Pilot program for Biocompatibility
  • Michigan Cannabis Regulatory Agency program requirements
  • ISO 20387 Biobanking

ASTM Approves New Cannabis Standards

By Cannabis Industry Journal Staff
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According to a press release sent out today, ASTM International’s D37 cannabis committee has approved three new standards for environmental conditions during packaging, shipping and storing cannabis and hemp flower. The three new standards are:

  • Standard Specification for Environmental Conditions for Post Packaged Storage and Retail Merchandising of Cannabis/Hemp Flower (soon to be published as D8423);
  • Standard Specification for Environmental Conditions While In-Transit for Packaged Cannabis/Hemp Flower (soon to be published as D8432); and
  • Standard Specification for Environmental Conditions While Packaging Cannabis/Hemp Flower (D8450).

ASTM members will be presenting at the Cannabis Quality Conference & Expo, October 17-19 in New Jersey. Click here for more information. Jonathan DeVries, a member of ASTM, says these standards are designed for the entire cannabis supply chain, from cultivation, manufacturing and transportation all the way to the end consumers. “These standards are designed to support the safety and quality of packaged cannabis and hemp flower as it moves through the supply chain,” says DeVries. “This includes the activities following curing and drying, namely packaging, transit, and storage, until it reaches the final end user.”

The ASTM D37 committee is working on a number of other standards related to these and they invite anyone interested to share their feedback.

ASTM Launches Standard for International Intoxicating Cannabinoid Symbol

By Cannabis Industry Journal Staff
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A new ASTM International standard seeks to create an internationally recognized symbol that indicates a product contains intoxicating cannabinoids. The cannabis technical committee at ASTM, D37, developed the standard for the International Intoxicating Cannabinoid Product Symbol (IICPS).

The International Intoxicating Cannabinoid Product Symbol (IICPS)

The standard is labeled D8441/D8441M and is supposed to be used with all finished consumer use products, including topical use, ingestion and inhalation. ASTM International members David L. Nathan, M.D. and Eli Nathan designed the symbol with a group of volunteers from the D37 led by Martha Bajec, PhD of HCD Research. The symbol was concurrently developed by Doctors for Cannabis Regulation (DFCR) and Subcommittee D37.04 on Cannabis Processing and Handling. The symbol is designed “to create a truly universal cannabinoid product symbol, mindful of its importance as a means to communicating to adults and children the need for caution with products containing cannabinoids,” says Dr. Nathan. “The symbol has the potential to facilitate a spirit of collaboration among experts, regulators, and all other stakeholders in the cannabis industry.”

Darwin Millard, subcommittee vicechair for ASTM D37.04 and subcommittee co-chair for ASTM D37.07, says this is perhaps one of the most important standards to come out of the committee. “It serves to establish a harmonized warning symbol that is truly international,” says Millard. “It is not intended to replace symbols that have already been established, rather it is intended to be used by marketplaces that have yet to establish a symbol.” As more and more marketplaces adopt the symbol, the hope is that markets with their own symbol will harmonize with the ASTM symbol over time.

Millard says the symbol uses the ISO standard warning triangle, the ANSI standard warning orange/yellow and defines a standardized icon for cannabinoids, the leaf. “There are a number of cannabinoids that are intoxicating, not just delta-9-THC, therefore the symbol is designed to be used to identify any cannabinoid that can be classified as intoxicating,” says Millard. “The symbol doesn’t care if the cannabinoid is naturally derived, isolated and purified, synthesized by yeast or created in a lab; if it is ‘intoxicating’ and a ‘cannabinoid’ the symbol can be used to identify a consumer product containing it. ‘Intoxicating’ was used over ‘inebriating’ or ‘psychoactive’ since neither term is correct. Impairing was recently used by Washington State and might be worth considering down the road.”

The IICPS became the official symbol for the state of Montana as of January 1st. New Jersey and Vermont have also incorporated the IICPS design into their state symbols, already making it the most widely adopted cannabis product symbol in fully legalized states. Alaska and other states are currently discussing use of the symbol as well.

If you are interested in contributing to the development of this and other D37 standards, you are encouraged to join the committee. In addition, they will be hosting a free webinar on June 1 to discuss the development of the international symbol, how to use it and how the marketplace and consumers will benefit from it.

Nonprofits Focus Lens on Delta-8-THC

By Cannabis Industry Journal Staff
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On December 2, ASTM International, released a whitepaper called “Delta-8-Tetrahydrocannabinol and the Need to Develop Standards to Protect Safety of Consumers.” On the same day, the U.S. Pharmacopeia (USP) launched an expert panel, drafting commentary and providing recommendations to protect public health. The two organizations are working in tandem to better educate the public as well as regulators on the science behind the risks that delta-8-THC products pose to the public.

The chemical structure of Delta 8 THC.

ASTM has been working in the cannabis industry through their D37 committee since March of 2017. Soon after the D37 committee launched, they began crafting cannabis standards and have grown their membership and subcommittees considerably over the past few years. USP has also been involved in the cannabis space for quite some time, developing reference standards and offering guidance for the cannabis testing market.

The ASTM whitepaper details the current landscape for hemp-based products that contain delta-8-thc derived from CBD. It includes information on what the cannabinoid is, how it’s produced, the emergence of delta-8-thc in hemp markets and the need for better safety and performance standards.

David Vaillencourt, frequent CIJ contributor and ASTM International member, says they want to identify how we can maintain public safety when it comes to delta-8-THC. “Products containing delta-8-THC are widely available to consumers despite the known and unknown risks to consumer health and safety,” says Vaillencourt. “The topic is much deeper than simply the presence of delta-8-THC. Rather it is about defining how to label products containing potentially intoxicating cannabinoids and identifying what safeguards need to be in place to minimize the risk of impurities that can further impact consumer health.”

In addition to the technical information provided, ASTM’s whitepaper also discusses the risks of synthetic cannabinoids to public health and the regulatory landscape surrounding delta-8-THC. USP’s whitepaper discusses the chemical process that creates delta-8-THC, the unregulated market and offers guidance on how to regulate the cannabinoid with labeling and testing rules.

Dr. Ikhlas Khan, chairman of USP’s expert panel on cannabis, says we need a lot more research.  “The fact of the matter is that little is known about the products labeled as containing delta-8, so much so that the FDA and CDC have both released advisories about the products,” says Khan. “Depending on how the products are produced, unknown impurities may be introduced, including minor and synthetic cannabinoid compounds that are not naturally occurring in cannabis.”

Delta-8-THC is not inherently unsafe, says Dr. Nandakumara Sarma, Director of Dietary Supplements and Herbal Medicines for USP. But as we’ve covered this before, the methods that manufacturers use to produce delta-8-THC could have harmful byproducts present in final products. “Synthetically derived cannabinoids are not necessarily inherently unsafe if they are quality controlled and shown to be safe,” says Dr. Sarma. “By using public quality standards, we can help in controlling the quality of the products and set appropriate limits for impurities.”

The folks at USP and ASTM will host a presentation on the two papers during ASTM’s 2nd Global Workshop on Advancing the Field of Cannabis through Standardization, to be held virtually Dec. 14, 2021. Click here to register.

ASTM International Launches New Subcommittee

By Cannabis Industry Journal Staff
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ASTM International, the renowned global standards body, has established a new subcommittee, D37.92, aimed at facilitating the exchange of ideas and information between policymakers, regulatory bodies, scientists, stakeholders and the public.

According to a press release, the new subcommittee, at the request of the U.S. Senate, has provided comments on the proposed Cannabis Administration and Opportunity Act (CAOA). The comments including the sharing of ASTM’s work in the cannabis industry, their organization, membership information, defining cannabis terms and their published standards related to facilities, consumer safety and other areas.

David Vaillencourt, frequent contributor to CIJ and chair of the new subcommittee

The subcommittee is headed up by David Vaillencourt, founder & CEO of The GMP Collective and frequent contributor to Cannabis Industry Journal. “With a patchwork of regulations across state, federal, and international levels, this subcommittee will be valuable to industry and government stakeholders as a means to collaborate,” says Vaillencourt, current chair of the new government liaison subcommittee. “It’s really going to facilitate dialogue that will be key as we look ahead to a global marketplace in the coming years.”

ASTM has been working with the cannabis industry through their D37 committee since March of 2017. Soon after the D37 committee launched, they began crafting cannabis standards and have grown their membership and subcommittees considerably over the past few years. In August of this year, they announced the development a new voluntary, consensus-based standard, the Change Control Process Management standard. The new committee, D37.92, is currently seeking public participation in their work to develop the new standard. To learn more about cannabis committee participation and membership, click here.