Tag Archives: D37

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.

February 8, 2023

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.

March 17, 2022

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 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.

October 26, 2021

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.

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.

August 18, 2021

ASTM Proposes New Standard on Change Control Process Management

By Cannabis Industry Journal Staff

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Change control, when it comes to quality management systems in manufacturing, processing and producing products such as cannabis edibles or vape pens, is a process where changes to a product or production line are introduced in a controlled and coordinated manner. The purpose of change control process management is to reduce the possibility of unneeded changes disrupting a system, introducing errors or increasing costs unnecessarily.

ASTM International, the international standards development organization, is developing a new standard guide that will cover change control process management for the cannabis and hemp market. The guide is being developed through the D37 cannabis committee.

The WK77590 guide will establish a standardized method for change control process management for cannabis companies so that they can document and track important decisions in manufacturing and quality systems.

For example, an edibles manufacturer would utilize change control process management if they want to use a different type of processing equipment or introduce a new shape or design of their product. Without change control process management, that edibles producer might switch to a new piece of processing equipment without knowing that it requires more energy or uses different raw materials, thus making production unexpectedly more expensive.

While that’s a very cursory example, the premise is simple: Before you undergo a change to your process, plan it out, analyze it, review it, test it out, implement it and make sure it works.

Change control process management can often be summarized in six steps:

Food processing and sanitation — Change control is designed to coordinate changes to manufacturing so they don’t disrupt a process.

Plan/Scope
Assess/Analyze
Review/Approval
Build/Test
Implement
Close

Maribel Colón, quality assurance consultant and vice chair of the ASTM subcommittee on cannabis quality management systems, says producers and testing labs will benefit the most from the guide. “As the cannabis industry grows, the quality, expectations, and control challenges grow within,” says Colón. “The creation and implementation of this standard guide will increase cannabis business efficiency and minimize risk, time, and potential cost of poorly managed changes.”

According to a press release, ASTM International is open to collaboration on this as well. Specifically, they are looking for professionals with change control who might be interested in helping advance and develop this guide.

June 9, 2021

How Effective is Your Internal Auditing Program?

By David Vaillencourt

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The word “audit” evokes various emotions depending on your role in an organization and the context of the audit. While most are familiar with and loathe the IRS’s potential for a tax audit, the audits we are going to discuss today are (or should be) welcomed – proactive internal quality audits. A softer term that is also acceptable is “self-assessment.” These are independent assessments conducted to determine how effective an organization’s risk management, processes and general governance is.

“How do you know where you’re going if you don’t know where you’ve been” – Maya Angelou

Internal quality audits are critical to ensuring the safety of products, workers, consumers and the environment. When planned and performed periodically, these audits provide credible, consistent and objective evidence to inform the organization of its risks, weaknesses and opportunities for improvement. Ask yourself the question: do your clients/vendors rely on you to produce reliable, consistent and safe products? Assuming the answer is yes, what confidence do you have, and where is the documented evidence to support it?

Compliance units within cannabis businesses are typically responsible for ensuring a business stays legally compliant with state and federal regulations. This level of minimum compliance is critical to prevent fines and ensure licenses are not revoked. However, compliance audits rarely include fundamental components that leave cannabis operators exposed to many unnecessary risks.

As a producer of medical and adult-use products that are ingested, inhaled or consumed in other forms by our friends, family and neighbors, how can you be sure that these products are produced safely and consistently? Are you confident that the legal requirements mandated by your state cannabis control board are sufficient? Judging by the number of recalls and frustrations voiced by the industry regarding the myriad of regulations, I would bet the answer is no.

What questions do internal audits address? Some examples include:

Are you operating as management intends?
How effective is your system in meeting specified objectives? These objectives could include quality metrics of your products, on-time delivery rates and other client/customer satisfaction metrics.
Are there opportunities to improve?
Are you doing what you say you do (in your SOPs), and do you have the recorded evidence (records) to prove it?
Are you meeting the requirements of all applicable government regulations?

There are potential drawbacks to internal audits. For one, as impartiality is essential in internal audits, it may be challenging to identify an impartial internal auditor in a small operation. If your team always feels like it is in firefighting mode, it may feel like a luxury to take the time to pull members out of their day-to-day duties and disrupt ongoing operations for an audit. Some fear that as internal assessments are meant to be more thorough than external assessments, a laundry list of to-do items may be uncovered due to the audit. But, these self-assessments often uncover issues that have resulted in operational efficiencies in the first place. This resulting “laundry list” then affords a proactive tool to implement corrective actions in an organized manner that can prevent the recurrence of major issues, as well as prevent new issues. The benefits of internal audits outweigh the drawbacks; not to mention, conducting internal audits is required by nearly every globally-recognized program, both voluntary (e.g. ISO 9001 or ASTM Internationals’s Cannabis Certification Program) and government required programs such as 21 CFR 211 for Pharmaceuticals.

Internal Auditing is a catalyst for improving an organization’s effectiveness and efficiency by providing insight and recommendations based on analyses and assessments of data and business processes. Additional benefits of internal audits include giving your organization the means to:

Ensure compliance to the requirements of internal, international and industry standards as well as regulations and customer requirements
Determine the effectiveness of the implemented system in meeting specified objectives (quality, environmental, financial)
Explore opportunities for improvement
Meet statutory and regulatory requirements
Provide feedback to Top Management
Lower the cost of poor quality

Findings from all audits must be addressed. This is typically done in accordance with a CAPA (Corrective Action Preventive Action) program. To many unfamiliar with Quality Management Systems, this may be a new term. As of Jan 1, 2021, this is now a requirement for all cannabis licensed operators in Colorado. Many other states require a CAPA program or similar. Continuing education units (CEUs) are available through ASTM International’s CAPA training program, which was developed specifically for the cannabis industry.

Examples of common audit findings that require CAPAs include:

Calibration – Production and test equipment must be calibrated to ensure they provide accurate and repeatable results.
Document and record control – Documents and records need to be readily accessible but protected from unintended use.
Supplier management – Most standards have various requirements for supplier management that may include auditing suppliers, monitoring supplier performance, only using suppliers certified to specific standards, etc.
Internal audits – Believe it or not, since internal audits are required by many programs, it’s not uncommon to have a finding related to internal audits! Findings from an internal audit can include not conducting audits on schedule, not addressing audit findings or not having a properly qualified internal auditor. Are you looking for more guidance? Last year, members of ASTM International’s D37 Committee on Cannabis approved a Standard Guide for Cannabis and Hemp Operation Compliance Audits, ASTM D8308-21.

If you are still on the fence about the value of an internal audit, given the option of an inspector uncovering a non-conformance or your own team discovering and then correcting it, which would you prefer? With fines easily exceeding $100,000 by many cannabis enforcement units, the answer should be clear. Internal audits are a valuable tool that should not be feared.

May 13, 2021

Defining Hemp: Classifications, Policies & Markets, Part 2

By Darwin Millard

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In Part 1 of this series we answered the question: What is “hemp”; and addressed some of the consequences of defining “hemp” as a thing. In Part 2, I will explore this topic in more detail and provide some commonsense definitions for several traditional hemp products based on a classification approach rather than separating “cannabis” from “hemp”.

Classifications, Specifications, and Test Methods – Establishing Market Protections for Hemp Products Through Standardization

Does making a distinction between “hemp” and “cannabis” make it easier to protect the interests of the seed and fiber markets?

On the face of it, this question seems obvious. Yes, it does.

Up to this point in history, the bifurcation of the cannabis plant into resin types and non-resin types has served to provide protections for the seed and fiber markets by making it easier for producers to operate, since the resins (the scary cannabinoids, namely d9-THC) were not involved. Today, however, the line in the sand, has been washed away, and “hemp” no longer only refers to non-resin producing varieties of the cannabis plant.

The structure of cannabidiol (CBD), one of 400 active compounds found in cannabis.

As more and more hemp marketplaces come online with varying limits for d9-THC the need for standardization becomes even more pressing. Without standardization, each marketplace will have its own requirements, forcing businesses looking to sell their products in multiple jurisdictions to comply with each region’s mandates and adds a significant level of burden to their operations.

Providing an internationally harmonized definition for hemp is an important first step but allowing the d9-THC limit to vary from jurisdiction to jurisdiction has some unintended (or intended) consequences (#NewReeferMadness). These discrepancies between legal marketplaces will inevitably lead to the establishment of global trade regions; where, if your product cannot meet the definition of “hemp” in that region, then you could effectively be barred from participating in it.

A process which has already started. Harmonizing around 0.3% is great for the US, Canada, and European Union, but what about other stakeholders outside of these markets?

And, at what point does the conflict of hemp from one region with a d9-THC content of 0.3% and hemp from another region with a d9-THC content of 1% being sold into the same market become a problem?

Perhaps a better long-term solution for protecting the market interests of “hemp product” stakeholders would be to establish specifications, such as identity metrics, total cannabinoid content, especially d9-THC, and other quality attributes which have to be verified using test methods for a product to be classified as “hemp”. This system of standards (classifications, specifications, and test methods) would allow for more innovation and make it significantly easier for cannabis raw materials that meet these specifications to find a use rather than being sent to the landfill. Bolstering advancements and opening the door for more market acceptance of the cannabis plant, its parts, and products.

An Alternative Approach to Defining Hemp

Below are some proposed definitions related to common terminology used in the hemp marketplace based on the concept that there are no hemp plants, there are only cannabis plants that can be classified as hemp, and hemp products are simply cannabis products that meet certain specifications to allow them to be classified and represented as hemp.

Hemp, n—commercial name given to a cannabis plant, its parts, and products derived therefrom with a total d9-THC content no more than the maximum allowable limit for the item in question. (Maybe not the best definition, but it makes it clear that not only does the limit for d9-THC vary from jurisdiction to jurisdiction it varies from product type to product type as well.)
Hemp flower, n—commercial name for the inflorescence of a cannabis plant that can be classified as hemp.
Hemp seed, n—commercial name for the seeds of a cannabis plant which are intended to be used to grow another cannabis plant that can be classified as hemp.
Hempseed, n—commercial name for the seeds of a cannabis plant which are intended to be used as food or as an ingredient in food.
Hemp seed oil, n—commercial name for the oils expressed from the seeds of a cannabis plant.
Hemp seed cake, n—commercial name for the solid material byproduct generated during the expression of the oil from the seeds of a cannabis plant.
Hemp flour/meal/dietary-fiber, n—commercial name for the powdered seed cake of a cannabis plant intended to be used as a food or as an ingredient in food with a protein content no more than 35% by weight.
Hemp protein powder, n—commercial name for the powdered seed cake of a cannabis plant intended to be used as a food or as an ingredient in food with a protein content between 35% and 80% by weight.
Hemp protein isolate, n—commercial name for the powdered seed cake of a cannabis plant intended to be used as a food or as an ingredient in food with a protein content above 80% by weight.
Hemp fiber, n—commercial name for the cellulosic-based natural fibers of a cannabis plant.
Hemp shives, n—commercial name for the hurd of a cannabis plant which have been processed to defined specifications.
Hempcrete, n—commercial name for a solid amalgamation of various aggregates and binders, typically comprised of the hurd (shives) of a cannabis plant and lime.

The d9-THC limits for each product were purposefully omitted because these specifications still need to be defined for each product type. Leaving the d9-THC limit up to each authority having jurisdiction, however, is not the answer. It is fine if you comply with a lower d9-THC limit and want to sell into a market with a higher d9-THC limit, but what do you do if you are above the limit for the market you want to sell into? For now, you lose out on potential revenue.

I am not advocating that everyone starts selling “hemp” as “cannabis,” or vice versa, far from it. I am advocating for a more commonsense and inclusive approach to the marketplace though. One that would allow for the commercialization of materials that would normally be going to waste.

To me it is simply logical. There are no hemp plants, there are only cannabis plants that can be classified as hemp. There are no hemp products, there are only cannabis products that can be classified as hemp. In order for a cannabis product to be marketed, labeled, and sold as a hemp product, i.e. to be classified as a hemp, it would need to meet a set of specifications and be verified using a set of test methods first. But fundamentally the product would be a cannabis product being certified as “hemp”. And that is the shift in thinking that I am trying to get across.

Exclusionary Actions – Disenfranchising Stakeholders

The cannabis plant is an amazing plant and to fully capitalize on the potential of this crop we have to start allowing for the commercialization of cannabis raw materials that are not controlled by the UN Single Conventions, i.e. the seeds, stalks, roots, and leaves when not accompanied by the fruiting tops or the resin glands. Not to do so disenfranchises a significant number of stakeholders from participating in established legal avenues of trade for these goods. A concept proposed and endorsed the ASTM D37 in the published standard D8245-19: Guide for Disposal of Resin-Containing Cannabis Raw Materials and Downstream Products.

If you are stakeholder in the hemp marketplace, you may feel threatened by the idea of the market getting flooded with material, but how are the demands of the so called “green economy” going to be met without access to more supply? Organic hemp seed for food production is scarce but there is plenty of conventional hemp seed for the current demand, but what happens when hempmilk is positioned to displace soymilk in every major grocery store? To feed the growth of the human population and allow for a transition to a truly “green economy,” we need to ensure that the policies that we are putting in place are not excluding those looking to participate in the industry and disenfranchising stakeholders from burgeoning marketplaces, nor alienating a segment of the marketplace simply because their plant cannot be classified as “hemp”.

Until next time…

Live long and process.

April 29, 2021

Defining Hemp: Classifications, Policies & Markets, Part 1

By Darwin Millard

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What is “hemp”?

The word “hemp” has many meanings. Historically the term has been used as the common name for the Cannabis sativa L. plant. Just like other plants, the cannabis plant has two names, a common name, hemp, and a scientific name, Cannabis sativa L. After the ratification of the UN Single Conventions on Narcotic Drugs and Psychotropic Substances, in 1961 and 1972 respectively, the term started to be used to distinguish between resin producing varieties of the cannabis plant and non-resin producing varieties of the cannabis plant. Nowadays the term is generally used to refer to cannabis plants with a delta-9-tetrahydrocannabinol (d9-THC), a controlled substance, content equal to or less than the maximum allowable limit defined by each marketplace.

Tetrahydrocannabinol (THC), just one of hundreds of cannabinoids found in cannabis.

In the United States and Canada, the limit is defined as 0.3% on a dry weight bases, and until November 2020, in the European Union, the limit was defined as 0.2%. After years of effort the “hemp” industry in Europe was successfully able to get the limit raised to 0.3% to be in line with the United States and Canada – creating the largest global trade region for hemp products. But there exist several marketplaces around the world where, either through the consequences of geographic location or more progressive regulations, the d9-THC content in the plant can be substantially higher than 0.3% and still considered “hemp” by the local authority.

To address these variances, ASTM International’s Technical Committee D37 on Cannabis has been working on a harmonized definition of hemp, or industrial hemp, depending on the authority having jurisdiction, through the efforts of its Subcommittee D37.07 on Industrial Hemp. The following is a proposed working definition:

hemp, n—a Cannabis sativa L. plant, or any part of that plant, in which the concentration of total delta-9 THC in the fruiting tops is equal to or less than the regulated maximum level as established by an authority having jurisdiction.

Discussion: The term “Industrial Hemp” is synonymous with “Hemp”.

Note: Total delta-9 THC is calculated as Δ⁹-tetrahydrocannabinol (delta-9 THC) + (0.877 x Δ⁹-tetrahydrocannabinolic acid).

This definition goes a long way to harmonize the various definitions of hemp from around the world, but it also defines “hemp” as a thing rather than as a classification for a type of cannabis plant or cannabis product. This is a concept rooted in the regulatory consequences of the UN Single Conventions, and one I strongly disagree with.

The definition also leaves the total d9-THC limit open-ended rather than establishing a specified limit. An issue I will address further in this series.

Can “hemp products” only come from “hemp plants”?

If you are an invested stakeholder in the traditional “hemp” marketplace, you would say, yes.

But are there such things as “hemp plants” or are there only cannabis plants that can be classified as “hemp”? (The definition for hemp clearly states that it is a cannabis plant…)

There is no distinction between the cannabinoids, seeds, and fibers derived from a cannabis plant that can be classified as “hemp” and those derived from a cannabis plant that cannot. The only difference is the word: “cannabis,” and the slew of negative connotations that come along with it. (Negative connotations that continue to be propagated subconsciously, or consciously, whenever someone says the “hemp plant” has 50,000+ uses, and counting, and will save the world because it’s so green and awesome, but not the “cannabis plant”, no that’s evil and bad, stay away! #NewReeferMadness)

The declaration that “hemp products” only come from “hemp plants” has some major implications. “Hemp seeds” can only come from “hemp plants”. “Hemp seed oils” can only come from “hemp seeds”. “Hemp fibers” can only come from “hemp plants”. Etc.

What does that really mean? What are the real-world impacts of this line of thinking?

Flat out it means that if you are growing a cannabis plant with a d9-THC content above the limit for that plant or its parts to be classified as “hemp”, then the entire crop is subjected to the same rules as d9-THC itself and considered a controlled substance. This means that literal tons of usable material with no resin content whatsoever are destroyed annually rather than being utilized in a commercial application simply because a part or parts of the plant they came from did not meet the d9-THC limit.

Some of the many products on the market today derived from hemp

It is well known that d9-THC content is concentrated in the glandular trichomes (resin glands) which are themselves concentrated to the fruiting tops of the plant. Once the leaves, seeds, stalks, stems, roots, etc. have been separated from the fruiting tops and/or the resin glands, then as long as these materials meet the authority having jurisdiction’s specifications for “hemp” there should be no reason why these materials could not be marketed and sold as “hemp”.

There are several reasons why a classification approach to “hemp plants” and “hemp products” makes more long-term sense than a bifurcation of the “cannabis” and “hemp” marketplaces, namely from a sustainability aspect, but also to aid in eliminating the frankly unwarranted stigma associated with the cannabis plant. #NewReeferMadness

That said, say you are a producer making shives from the stalks of cannabis plants that can be classified as “hemp” and then all of a sudden, the market opens up and tons of material from cannabis plants that cannot be classified as “hemp,” that was being sent to the landfill, become available for making shives. Would you be happy about this development? Or would you fight tooth and nail to prevent it from happening?

In this segment, we looked at the history of the term “hemp” and some of the consequences from drawing a line in the sand between “cannabis” and “hemp”. I dive deeper into this topic and provide some commonsense definitions for several traditional hemp products in Part 2 of Defining Hemp: Classifications, Policies & Markets.

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.