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View the July/August Issue of Cannabis Science and Technology!

MM411's Journey: From Grassroots Beginnings to Global Cannabis Education Leader

A Better Cannabis Product Testing System

Understanding Aspergillus Contamination in Cannabis Flowers and the Risks to Immunocompromised Individuals

Topics

Cannabidiol (CBD)

Quality Control and Quality Assurance (QA and QC)

1rem

Authors

Reference standard qualifications are discussed and techniques for qualifying incoming reference standards are suggested.

Setting the Standard: Considerations When Handling  DEA-Exempt Cannabinoid Reference Standard Preparations Used for Potency Determination

This article has been updated on December 4, 2024 with the addition of comments from Kim Anzarut, Lo Friesen, and Adam Jacques.

The U.S. Senate Committee on Agriculture, Nutrition, & Forestry has introduced the Rural Prosperity and Food Security Act, which will serve as the Senate’s draft for the 2024 Farm Bill. The bill sets forth new regulations for the cultivation and harvesting of hemp. In one notable change, the new bill revises the definition of hemp. While hemp since the 2018 Farm Bill has been defined as 

. containing no more than 0.3 percent delta-9 THC by dry weight, the new bill strikes “delta-9” and applies the limit of 0.3 percentage by dry weight to “total THC.” 

This means regulators will make no distinction between the different types of THC in the plant. This decision may close the so-called “loopholes” that relate to minor cannabinoids such as delta-8 THC, which have been making their way into food and beverage products throughout the country. A number of states have taken matters into their own hands, many outright banning products containing intoxicating hemp cannabinoids such as delta-8 THC. This revision will most likely make hemp farming and processing more difficult as well since it creates a higher standard for THC limits.

Kim Anzarut, founder of Allay Consulting, stated, "The inclusion of "total THC" in the definition of hemp as 0.3% or below is a significant shift that will undoubtedly make compliance more challenging for the industry. This change closes loopholes that previously allowed products to bypass regulations by focusing solely on delta-9 THC, but it also creates new hurdles for hemp growers and processors." Anzarut added, "Achieving these stricter limits will likely require additional resources, tighter testing protocols, and possibly even changes to cultivation practices. While it’s a step toward more consistent regulation, it underscores the urgent need for standardized testing methods and better support for the industry to adapt."

Delving into the dynamics of THC and cannabinoid ratios, Chief Geneticist at AgSense LLC, Adam Jacques, commented, "CBD and THC function as a standard ratio, within a controlled channel based on their type. Type 1 THC, 2 1:1, 3 'hemp' CBD. There is not some special hemp plant that exists outside of these rules. When your CBD level increases in type 3 your THC will increase. That's been proven through many trials, it's the basic function of these plants. If you want 30% CBD you will have to deal with the 1%+ THC. We find the kind of sweet spot to not go over the .3% threshold is 11-15% CBD." Jacques continued how, "There is no natural way or synthetic way of stopping the plant from doing this. I have had success dropping numbers with the addition of ruderalis, but we are just dropping numbers down for the sake of meeting a 'law'. Once that oil is harvested from the plants the ratio will stay the same as lesser testing types. It costs farmers more land, water, labor, seed, time to grow inferior plants to meet a .3% threshold which is a completely arbitrary number that has no scientific basis in anything. That's the facts on that."

Providing her perspective on the updated Farm Bill text, Lo Friesen, founder, CEO, and Chief Extractor of Heylo expressed, "While this will mean a challenging transition for the national hemp market, I'm hopeful that this will encourage states to get involved with better regulating hemp CBD products and better support the current legal cannabis markets. Hemp derived THC products have become widely available to consumers in an unregulated environment." Friesen added how, "It's bad for consumers and bad for the legal cannabis markets. I hope we can find a middle ground where the hemp industry can continue to supply consumers with non-intoxicating products, like CBD products or industrial hemp products, and consumers can then turn to legal and regulated markets for THC products."

What may help compliance is the proposed Certified Seed Pilot Program in the bill, in which, “The Secretary may, in up to 5 States or Indian tribes, establish a pilot program under which the State department of agriculture of a selected State, or the equivalent Tribal government agency, may certify genetic purity…and identity as to variety…of varieties of seeds that have been bred to produce plants with a total tetrahydrocannabinol concentration (including tetrahydrocannabinolic acid) of not more than 0.3 percent on a dry weight basis.”

The new bill would also create a separate definition for Industrial Hemp and different licensing schemes for producers of industrial hemp. The definition of industrial hemp used in the bill is:

“the plant Cannabis sativa L. if the harvested material—

(i) the stalks of that plant, fiber produced from those stalks, or any other manufactured product, derivative, mixture, or preparation of those stalks (except cannabinoid resin extracted from those stalks);

(ii) whole grain, oil, cake, nut, hull, or any other compound, manufactured product, derivative, mixture, or preparation of the seeds of that plant (except cannabinoid resin extracted from the seeds of that plant); or

(iii) viable seeds of that plant produced solely for production or manufacture of any material described in clause (i) or

(B) will not be used in the manufacturing or synthesis of natural or synthetic cannabinoid products.’’

With the separate definition for industrial hemp, there is a separate license for industrial hemp in which producers are not required to undergo a background check when applying for the license. There are also relaxed regulatory requirements for testing compliance of industrial hemp products.

The U.S. Senate Committee on Agriculture, Nutrition, & Forestry has introduced the Rural Prosperity and Food Security Act, which will serve as the Senate’s draft for the 2024 Farm Bill.

Topic

Senate Committee has released the text of 2024 Farm Bill, with changes to hemp regulations

, AOAC INTERNATIONAL announced it has expanded its ISO/IEC 17043 accreditation to include six cannabis and hemp oil proficiency testing (PT) programs (1). Two cannabis dried flower/biomass programs (pesticide residues and mycotoxins) were also included in the approval. This is the first oil PT program able to ship >0.3% tetrahydrocannabinol (THC) oil samples across state lines. The available samples include: <0.3% THC hemp oil and >0.3% THC cannabis oil for cannabinoids, terpenes, water activity, heavy metals, pesticide residues, residual solvents, and mycotoxins.

The proficiency testing programs were accredited by the American Association for Laboratory Accreditation (A2LA), one of the largest accreditation bodies worldwide. A2LA offers a full range of comprehensive conformity assessment accreditation services.

“This is a huge accomplishment to have these, first of their kind, PT programs covered by accreditation,” stated Shane Flynn, AOAC’s Senior Director of Laboratory Proficiency Testing, in the press release.

According to their website, some of the features AOAC ISO 17043 accredited PT programs offer analytical laboratories include (2):

Independent assessment of a lab’s data accuracy and reliability

Comprehensive testing programs offering a wide array of analytes and matrices

High quality, homogeneous, stable testing samples that arrive ready to analyze, like routine samples

Founded in 1884, AOAC is a non-profit membership association that “brings together government, industry, and academia to establish standard methods of analysis that ensure the safety and integrity of foods and other products that impact public health around the world,” (1).

Laboratories are now able to enroll in the next AOAC Cannabis/Hemp Oil Proficiency Testing Program, which will be shipped in early December 2024.

AOAC INTERNATIONAL. AOAC is Now Accredited for Cannabis and Hemp Oil PT 

https://www.aoac.org/news/aoac-is-now-accredited-for-cannabis-and-hemp-oil-pt/

AOAC INTERNATIONAL. Proficiency Testing Program 

https://www.aoac.org/scientific-solutions/proficiency-testing/

Accredited by A2LA, the scope of accreditation to ISO/IEC 17043 now includes six cannabis and hemp oil proficiency testing programs.

AOAC INTERNATIONAL’s ISO 17043 Accreditation Expanded to Cannabis and Hemp Oil Proficiency Testing

 examined the possible connections between the endocannabinoid system (ECS) and attention deficit hyperactivity disorder (ADHD) symptoms. The review, “Attention Deficit Hyperactivity Disorder, Cannabis Use, and the Endocannabinoid System: A Scoping Review,” was published in 

 in September 2024. Noting the prevalence of cannabis use and misuse in individuals with ADHD, and the lack of understanding between cannabis use and ADHD pathophysiology, researchers conducted a scoping review on preclinical and clinical evidence on the ECS and ADHD. No specific reviews have been done yet in this area, they noted.

To examine the potential therapeutic effects and influence of the ECS, researchers searched PubMed, PsyINFO, EMBASE, and the Cochrane Library for studies published up to March 2022 and examined data from relevant clinical and preclinical studies. They closely examined 13 of the studies. Data from five preclinical studies, five clinical studies examining effects of cannabis on cognition, and two clinical studies examining effects of cannabis on ADHD symptoms were presented in tables.

Data from the preclinical studies suggested that the ECS plays a role in regulating neurocognitive functions that are dysregulated in ADHD. In particular, the studies suggested:

Persistent adolescent-like behavior in adults is mediated by Cannabinoid 1 receptor (CB1R) function.

The ECS modulates impulsivity, particularly inhibitory control, which provides a possible target for managing attention-related deficits.

Data from clinical studies was sparse, the researchers noted, and should be interpreted with caution. The data focused on the ECS and executive function, inhibition control and impulsivity, and ADHD symptomatology. Some of the findings from the data included:

THC administration impaired executive function during a continuous performance task, suggesting ECS involvement in ADHD-related abnormal default mode network (DMN) activity.

ADHD diagnosis impacted executive function more significantly than cannabis use.

Some surveys showed that cannabis use improved some ADHD symptoms, yet other studies found no improvements in symptoms when using cannabinoid medications.

“Findings from this review suggest both potential therapeutic benefits and detrimental drug interactions for individuals with ADHD using cannabinoids,” researchers noted in the concluding remarks. “Despite the growing popular opinion that cannabis and cannabinoids may be a therapeutic agent for ADHD symptoms, several critical questions remain unanswered. More rigorous and comprehensive studies are needed to fully understand the safety and efficacy of cannabinoid therapies in individuals with ADHD.”

The research received funding from the National Institutes of Health and two internal grants from Thomas Jefferson University.

Ryan, JE.; Fruchtman, M.; Sparr-Jaswa, A.; Knehans, A.; Worster, B. Attention Deficit Hyperactivity Disorder, Cannabis Use, and the Endocannabinoid System: A Scoping Review. 

A recent review explored the connection between ADHD symptoms, cannabis use, the ECS, and potential therapeutic effects.

The Endocannabinoid System’s Role in ADHD: Insights from a Comprehensive Scoping Review

 presented the 27th installment in their monthly webinar series When Things Go Wrong. This episode titled, “Cannabis Cornucopia: Cultivating Abundance through Collaboration and Equity” featured guest speakers Ernest Toney, founder of BIPOCann and Dominique Mendiola, Senior Director at Colorado's Marijuana Enforcement Division & Natural Medicine Division and President of the Cannabis Regulators Association (CANNRA), and was moderated by Bethany Moore, Director of Content Strategy and Market Growth at the GMP Collective.

The theme of this webinar was the importance of collaboration, support networks, and supporting minority and underserved entrepreneurs in the industry for the benefit of all stakeholders. The first discussion point in the webinar focused on social equity and the challenges that social equity operators face. Ernest Toney defined social equity as “creating a process that is focused on fairness, justice, and giving people equitable access to opportunities to participate in the industry. That can look like policies that create pathways for entrepreneurs to participate and helping those communities and individuals, who were most negatively impact impacted [by prohibition], have an opportunity to participate.” Dominique Mendiola also noted the impact of creating deliberate discussions on progressing social equity opportunities beyond licensing eligibility and how people can access the resources available. She also noted the value of exploring learning opportunities and ways to increase stakeholder engagement and collaboration, specifically noting a social equity workshop with 

, Board Chair of the Minority Cannabis Business Association (MCBA). David Vaillencourt, CEO and founder of the GMP Collective, noted the ASTM International D37 subcommittee on diversity, equity, and inclusion as part an example of how to create a framework for social equity in the industry.

The next topic for discussion addressed how operators, regulators, and lawmakers could come together to advocate for improvement and change. Toney pointed out that in the federal rescheduling deliberations with the DEA, out of all who were selected to participate and provide feedback in the rescheduling discussion, there was no representation from a minority-focused organization. He stated, “If you don't have a voice from the people in the communities that have been most negatively impacted at the federal level, then we are intentionally repeating the same mistakes that got us to where we were in the first place. That's something I would like to see change.” Mendiola elaborated on regulators contributing to conversations that require collaboration. “We want a seat at the table to support the conversation around changes that we may be responsible for implementing,” she explained. “We focus on public health and safety, and that's just not limited to consumers, but also occupational safety and community safety. Those are areas that we want to make sure that we continue to have authority to respond to quickly, to maintain the integrity of our framework and continue to progress things forward in a really meaningful and productive way, and that requires collaboration with all voices.” Feedback from operators is also crucial for adapting to the constant changes in the industry, she added. Vaillencourt recommended that all stakeholders make data-driven decisions and engage early and often in policymaking decisions.

The panelists next discussed real-life examples of opportunities to share supportive programs. Toney discussed a mentorship program between the state of Colorado and BIPOCANN to offer grants to social equity applicators and guided structure to support the development of their business. He added, “I love the idea of creating ecosystems that provide accessible tools, knowledge, and resources, because at the end, it's going to help everybody win. What comes out of that is data. Now we can say, ‘these are the direct impacts of how those dollars were used, the real impacts of offering these programs and resources to boost businesses.’ You can take that back to regulators and other operators, and say, ‘this is an investment that you should continue to work on.’” He also suggested creating more pathways, such as scholarships, for more people to attend cannabis conferences as a way to promote the sharing of resources and knowledge. Mendiola explained examples of regulators providing proactive ways to support compliance through public-facing resources, education, and community outreach.

The next discussion topic focused on look at strategies for growth and how to reframe challenges as opportunities for collective success. Toney mentioned initiatives from the MCBA engaging with communities across the country and explained why businesses should be incorporating collaboration into their long-term goals for the future. Mendiola explained how CANNRA’s External Stakeholder Meetings bring many people together for tough yet valuable conversations where they can learn from one another. She also noted the importance of regulators continually reflecting on their requirements and ensuring that those rules are up-to-date and streamlined. Vaillencourt noted the importance of stakeholders realizing that they do not operate in silos: “It's about learning and sharing information. That's the only way we can move forward. If you take anything away from this today, it's to be willing to have hard conversations, ask questions, and have an open mind.”

Watch the full recording of this episode here

This month’s GMP Collective webinar focused on how collaboration within the industry can lead to overall growth and success.

Equity and Growth in the Cannabis Industry: Insights from a GMP Collective Webinar

 presented their 25th installment of the webinar series When Things Go Wrong. This episode, titled, “Croptober: Crucial Best Practices for Harvest Season,” featured guest speakers Alex Cass, Manager of Plant Sciences at Native Roots, and Nelson Oldham Associate Director of Post Harvest at Native Roots, and was moderated by Bethany Moore, Director of Content Strategy and Market Growth at the GMP Collective.

The first topic addressed was the ideal drying and curing process for cannabis, including key factors that cultivators should focus on to avoid issues. Nelson Oldham described the two processes and the overlaps between them. For the drying process, he noted the importance of starting with clean flower, environmental controls, temperature and humidity, standard operating processes, testing the buds for level of dryness, and measuring the level of moisture and water activity. For the curing process, he noted the continuing importance of environmental controls and temperature and humidity, plus how to avoid the proliferation of microbes and molds. Alex Cass elaborated on how to handle fungi and bacteria and how to prevent degradation or loss of cannabinoids and terpenes, or other aromatic compounds.

“As a grower, we all have a bunch of cheesy sayings when it comes to drying and curing, Nelson stated. “One of my favorite sayings is, ‘an ounce of prevention is worth a pound of cure,’ and if you're being diligent with your setup, if you're being diligent with scouting and ensuring that you're not putting unhealthy plants into your drying space, you'll be setting yourself up for success.”

Next, Oldham discussed mistakes seen the curing process and how to avoid them. He described the results seen between several different types of containers for storage or curing, burping containers during curing, and steps to ensure quality control. Cass noted the role of packaging. To provide a real-life example of what do when things go wrong, Oldham described the steps taken during a recent power outage at their facility to ensure the quality of the plants and products.

Cass described how the harvest season will impact the supply chain in the cannabis industry. He explained how processing facilities and areas can become hard to find in October due to bottlenecks, how schedules help stagger harvest and production, and some of the challenges and solutions outdoor facilities might face. He also explained which environmental factors—including water activity, temperature, and proper handlings and storage—are crucial to mitigating contamination risk of the final product. He also elaborated on steps employees can take to reduce contamination risk, including protective equipment and workflow movement. Oldham expanded on this by explaining standard operating procedures and employee training.

One of the questions from attendees focused on products being labeled as irradiated, remediated, or decontaminated, and specifically, should consumers know that that product has been treated in such a way? Cass explained the importance of protecting and educating the consumer, especially when combating misinformation. “I think that we should get as much information to the consumer as possible, but I think that we should also look at ways that we can educate the consumer, because, in my opinion, irradiation is a value add. I think that it increases the quality of our product. I think it increases our shelf life and safety for the consumer, and it is no small cost to our organization.”

In preparation for the outdoor cannabis harvest, this episode provided guidance on ensuring a successful production process. 

Andrew J. Aubin

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