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The Agenda for Cannabis Science Conference Spring is Ready!

This blog is in response to the recent announcement from the FDA regarding oversight in the CBD market

Update from the FDA: Not Adopting Existing Regulations for the CBD Industry

Check Out the Cannabis Science and Technology March Issue!

Share Your Work With Us and Help Educate the Cannabis Industry!

On this month’s episode, we are joined by James Schwartz, BSN, LNC CEO of Cascade High Organics 

Ep 13: Psychedelic Science: Understanding Emerging Research and Potential Therapeutic Applications

Better believe it, the Occupational Safety and Health Administration (OSHA) has regulatory jurisdiction over cannabis facilities—including cultivation, processing, manufacturing, laboratory, and retail. Businesses are required to ensure a safe workplace, including cannabis and hemp businesses regardless of their federal legalization status. Under the Occupational Safety and Health Act, employers must provide “employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his [their] employees.” Simply put, regardless of company type, companies are obligated to provide a safe workplace.

OSHA isn’t making regular visits to these kinds of facilities at this time, but they’re visiting on a complaint basis. This means if an employee, former employee, or other person sees an issue with worker safety in your facility they can report you to OSHA. This would then trigger the need for an unannounced site visit. During that visit the investigators will conduct an audit of the facility and will make you aware of any violations of OSHA regulations. They will later provide you with a full report of violations and the fines associated with those violations. This is not a good place to be in if you haven’t put any OSHA documents or practices in place.

Regulatory oversight of workplace safety is much-needed, especially in the booming cannabis industry. The OSHA standards are “written in blood,” meaning the regulations most likely stemmed from a terrible incident observed at a place of work. The regulated cannabis industry is young, yet we are seeing more workplace safety issues make the news in the saddest way possible.

Consequences From Not Ensuring Workplace Safety

OSHA incentivizes companies to abide by their standards by using hefty fines! And we mean hefty… the most serious penalty for a willful or repeated violation has a maximum of $136,532 per violation (1). Other than a monetary financial fine, other consequences may include criminal fines (employers have been sentenced to prison in extreme cases), disruptions to your business, time loss, and ultimately your revenue loss. It’s essential for your business to be well prepared prior to OSHA’s visit: for your bottom line, your employee’s safety, and your business’s reputation. Not only are employers required to provide a safe working environment, companies must also keep multiple records of work-related injuries or illnesses and various safety programs.

Workplace Fatality at a Cannabis Facility

A tragic workplace fatality occurred in January 2022 at a Trulieve Holyoke Holdings Massachusetts cannabis facility. OSHA concluded the death was caused from an occupational exposure to cannabis particulate dust. The unfortunate result was due to an asthmatic reaction. This sad fatality could have, and should have, been prevented.

Following the workplace death, OSHA conducted an investigation and identified three separate citations (2):

 Serious violation for not compiling a list of hazardous chemicals in the facility, including, but not limited to, ground cannabis, using a product identifier which was referenced on the appropriate safety data sheet.

 Serious violation for not obtaining or developing a safety data sheet for hazardous chemicals such as, but not limited to, ground cannabis, which was produced by grinding dried cannabis flower and packaging into pre-rolls.

 Serious violation for not providing effective information and training on hazards of the material, including but not limited to, exposure prevention, signs and symptoms of inhalation hazards involving the upper and/or lower respiratory tract and skin contact including irritation, itching, and/or hives, and the need for medical evaluation should symptoms develop.

 to Trulieve (with proposed fines), what is it going to take for businesses to take workplace safety seriously before we see more illness, injury, or death related incidents at cannabis facilities? Perhaps an increased awareness of OSHA expectations and increased regulatory oversight will encourage companies to see safety compliance as a need rather than a barrier. Whichever method of encouragement works, our goals are to ensure our employees leave work in the same way they arrived at work.

What Can Employers Do to Ensure a Safe Workplace?

Although employers have the responsibility to ensure a safe workplace, there isn’t much guidance for cannabis businesses on how to achieve compliance. Allay Consulting selected a few ways to ensure compliance at the workplace: hiring a safety professional, creating a safe workplace culture, and education.

In our experience, many employers do not know how to identify, prevent, or react to workplace hazards. Safety professionals provide you a workplace safety baseline to evaluate changes needed to become compliant. Specialists are better suited to investigate safety environments and failures. When injuries and illnesses occur at work, there are failures (often multiple) that led to these events; there is rarely a single cause. A safety professional will be able to determine what each unique facility is lacking and what they may need to become a safe and compliant workplace. Professionals will provide ways of fixing the concerns before it results in an injury, illness, death, or violations.

Make safety a part of your company culture! Make sure safety is a part of your daily talks and expectations. Make sure your standard operating procedures (SOP) and employee contracts mention safety compliance, so your employees have a clear understanding of what is expected of them. Encourage staff members to bring up their safety concerns. Validate their concerns. Something that has helped create a safety culture in my experience is to have departments conduct safety walks in other departments along with regular internal and third party audits. This allows new perspectives and observations in a work area.

Employers are expected to train their staff, especially when it comes to worker safety training. In fact, this is a federal requirement. OSHA requires health and safety program implementation along with evidence of training. For example, employers are expected to train their staff on the dangers of their workplace—this includes training on handling chemicals, how to properly wear a respirator, solvent transfilling, and so on. Unfortunately, Allay has seen many founded OSHA complaints based on lack of training.

There are more worker safety regulations to keep in mind than just OSHA. OSHA might be the highest fining department federally, but there are local and state jurisdictions that you must abide by as well. Make sure that your facility is being built with local excise licensing, building code, zoning, and fire codes in mind as well as OSHA. Keep in mind that OSHA is different than fire code compliance and every state and county has different fire regulations that need to be followed. OSHA and fire code definitely go hand in hand, but they are not exactly the same. There are also SOP and documentation requirements for these different entities as well. We always suggest you go online to see the regulations in your particular area that need to be followed and to reach out to your local regulatory bodies to get clarity on anything you might not understand. Being preventative rather than reactive to safety issues is always the way you want to be, trust me.

We love supporting our clients with mitigating risk and increasing safety at the workplace. We hope sharing these different compliance approaches provides useful insight and an opportunity to learn from our experience.

If you want to learn more about OSHA compliance in the cannabis industry, check out Vicente Sederberg’s webinar featuring Kelsey Hanley with Allay:

 OSHA Compliance in the Cannabis Industry: 

https://www.youtube.com/watch?v=0mfCcznCVZM

https://www.osha.gov/news/newsreleases/trade/01122023

https://www.bostonglobe.com/2022/12/27/marijuana/osha-settles-with-trulieve-over-marijuana-workers-death/

Kim Stuck is the CEO and founder of Allay Consulting. Direct correspondence to: 

Articles

Workplace safety procedures help companies be the best they can be, especially when it comes to ensuring your staff goes home the same way they arrived. These are just a few ways to begin your safety journey!

Workplace Safety Compliance in the Cannabis Industry

Listen as Dr. Reggie Gaudino, VP of Research & Development at Front Range Biosciences, shares a quick Noid Factoid with us!

In our December 2022 episode, we were joined by Dr. Reggie Gaudino, VP of R&D at Front Range Biosciences. Together, we discussed plant genetics and breeding with Dr. Gaudino to understand some of the challenges, successes, and perhaps where it should be heading in the future.

Hear more of what Dr. Reggie Gaudino has to say in the full Noid Knowledge podcast episode: 

https://www.cannabissciencetech.com/view/ep-12-plant-genetics-and-breeding-what-do-we-really-know-about-cannabis-

Don't miss this Noid Factoid from Dr. Reggie Gaudino, VP of R&D at Front Range Biosciences.

In Case You Missed It: Noid Factoid from Episode 12

This award is given to honor outstanding professional and continuing education programs allowing students to earn academic credit (1).

The Cannabis Science and Operations Certificate began in the fall 2020 semester in Saint Lous University’s (SLU) School for Professional Studies. It is the school’s most successful program in their history. The program has been offered for the last three years and currently enrolls 300 students and more than 140 graduates. It was the first of its kind in St. Louis.

Courses for this certificate program are taught by industry professionals and cover all aspects of cannabis operations. This includes (1):

The fundamentals of growing, manufacturing and dispensing cannabis

Cannabis extraction and product production

The certificate program is 16 hours and includes a research project.

“While this program is 100% online, there are hands-on opportunities in each course that are successfully preparing our students to work in every aspect of the cannabis industry, providing well-rounded employees,” said program director Stacy Godlewski (1).

Due to the program instructors being industry experts, students completing the certificate have opportunities to network nationally with those across a variety of fields.

“A high percentage of students are receiving job offers and reporting higher salaries due to the fact that they are enrolled in this program,” Godlewski added.

Students who have graduated from the program have been offered positions in cannabis sales, dispensary management, marketing, laboratory technology, and quality assurance.

SLU continues to expand their offerings for those interested in the cannabis industry. In January 2022, the School of Professional Studies created a Medical Cannabis Science and Therapeutic Management Certificate (2). This program is targeted for individuals who care for others by providing science-based education on cannabis-based therapy options.

https://www.newswise.com/articles/saint-louis-university-s-cannabis-science-certificate-wins-outstanding-program-award?ta=home

https://catalog.slu.edu/colleges-schools/professional-studies/medical-cannabis-science-therapeutic-management-pbc/

Saint Louis University’s (St. Louis, Missouri), Cannabis Science and Operations program received the 2023 Outstanding Program by the University Professional and Continuing Education Association (UPCEA).

Outstanding Program Award Granted to Saint Louis University's Cannabis Science Certificate

On March 22, 2023, Oregon Health Authority (OHA) announced the granting of the first psilocybin license to a woman-owned business–Satori Farms PDX LLC (1). In 2020, Oregon legalized psilocybin for therapeutic purposes and created the nation’s first regulatory framework for psilocybin services (2). The newly created Oregon Psilocybin Services (OPS) began accepting license applications in January and expects to issue more licenses to laboratories, service centers, and facilitators in the coming months (1).

“We congratulate Tori Armbrust of Satori Farms PDX LLC for being issued the first psilocybin license in Oregon’s history and for representing women leading the way for the emerging psilocybin ecosystem,” said OPS Section Manager Angie Allbee in the OHA announcement (1). “We are committed to fostering an inclusive partnership with our regulated community to ensure safe, effective and equitable psilocybin services throughout the state.”

Information for finding licensed psilocybin service centers and facilitators can be found on the OPS Licensee Directory website.

Earlier this month the first students graduated from training programs to become certified psilocybin therapy facilitators (3).

For an in-depth look at the regulations surrounding Oregon’s legalized psilocybin industry, check out this 

 blog entry from Kim Stuck, CEO and founder of Allay Consulting: 

https://www.cannabissciencetech.com/view/psilocybin-rule-update-oregons-newly-released-regulations

https://content.govdelivery.com/accounts/ORDHS/bulletins/350435f

https://apnews.com/article/oregon-psilocybin-first-license-psychedelic-mushrooms-caf03c42c1564c78c6b45892c69228b4

https://apnews.com/article/magic-mushroom-therapy-psilocybin-legalization-oregon-bd1b3c43cab74437e8868751c9c9591d

Oregon Psilocybin Services (OPS) issued first psilocybin manufacturer license since accepting applications earlier this year.

Oregon Issues First Psilocybin License to Portland Business

, recently conducted an interview with Michael Sassano, CEO at SOMAÍ Pharmaceuticals, to learn more about the European market and how pharmaceutical applications will shape up in the future.

There are various cannabis or cannabinoid-based products used in pharmacotherapy in Europe, mainly for treating chronic pain, nausea, and vomiting caused by chemotherapy. However, currently only one cannabinoid-based pharmaceutical product has been approved by the European Medicines Agency (EMA) under the centralized procedure, allowing it to be marketed throughout the entire European Union.

Click here to read the full article from 

https://www.pharmtech.com/view/advantageous-positioning-for-europe-in-pharmaceutical-cannabis

Read an interview from Pharmaceutical Times Europe exploring how the European bio/pharma industry’s high regulatory standards and GMP requirements are set to position the region as a frontrunner for pharmaceutical grade manufacturing of cannabis-based medicines.

Insights Into the Advantageous Positioning for Europe in Pharmaceutical Cannabis

In a study presented at the American Chemical Society spring meeting, researchers investigated whether different derivatives and dosages of cannabidiol (CBD) could be used as an adjunct or substitute for naloxone–sold as Narcan–in treatment of overdoses. Narcan is an antidote for overdoses of opiate drugs like fentanyl and works by blocking opioid receptor sites in the brain and the effects on the central nervous system (1).

To develop the CBD derivatives, researchers changed the structure of CBD to create new compounds, and eventually narrowed the field to 15 compounds that were tested against fentanyl, both with and without naloxone (2). Researchers found that some CBD derivatives prevented fentanyl from binding to opioid receptor sites, even at low concentrations, and two compounds enhanced naloxone's performance when used in combination with it. Past studies suggest that CBD can hamper opioid binding by altering the shape of receptor sites, forcing the receptors to release opioids and making naloxone treatment more effective (2).

“Mostly we’ve been trying to figure out which parts of the CBD compound were relevant for these effects and building on that to find compounds that are more effective,” said. Dr. Alex Straiker, the study’s co-principal investigator.

The researchers plan to conduct a follow-up animal study to test the most promising derivatives on mice.

https://www.healthline.com/health-news/cbd-compounds-may-help-reverse-opioid-overdoses#Combining-naloxone-and-CBD

https://www.news-medical.net/news/20230328/CBD-based-compounds-boost-the-effects-of-naloxone.aspx

Initial findings from a recent study suggested that cannabidiol (CBD) derivatives made naloxone treatment more effective, even against the opioid fentanyl.

Study Investigates Whether Cannabis Derivative Can Supplement Effects of Naloxone in Reversing Opioid Overdoses

On March 21, 2023, the study titled “Züri Can–Cannabis with responsibility,” created by the City of Zurich and the University of Zurich, met approval and opened its registration process, after being postponed in 2022. “The study examines the effects of purchasing selected cannabis products from controlled cultivation under regulated conditions on the consumption and health of the participants,” read the study, translated from German (1). “In addition, different models of regulated cannabis procurement are to be compared with one another.”

The sale of cannabis products for the study will begin at the preestablished supply points after the summer holidays, and only organic and local products will be permitted (1). Currently, cannabis products containing less than 1% THC are permitted in Switzerland under limited instances (2).

“As a study participant, you will contribute to research into a possible regulation of cannabis consumption in Switzerland,” read the consent form in part, translated from German (3). “If you meet the eligibility requirements below and are included in the study, you can legally purchase cannabis for personal use for three years under regulated conditions. As a study participant, you must fill out a scientific online questionnaire at regular intervals.”


Scientific, approved pilot trials of controlled sales of cannabis for recreational purposes were first allowed in 2021 (4). Future studies with public and university sponsors are planned for several more cities in Switzerland (1).

https://www.stadt-zuerich.ch/portal/de/index/politik_u_recht/stadtrat/weitere-politikfelder/drogen-suchtpolitik/studien-und-projekte/cannabisprojekt-der-stadt-zuerich/wissenswertes-zur-cannabis-studie.html

https://www.ch.ch/en/health/medicines-and-narcotic-substances/cannabis/#when-is-cannabis-an-illegal-drug

https://www.stadt-zuerich.ch/portal/de/index/politik_u_recht/stadtrat/weitere-politikfelder/drogen-suchtpolitik/studien-und-projekte/cannabisprojekt-der-stadt-zuerich/konsumierende.html

https://www.stadt-zuerich.ch/portal/de/index/politik_u_recht/stadtrat/weitere-politikfelder/drogen-suchtpolitik/studien-und-projekte/cannabisprojekt-der-stadt-zuerich.html#

The study will examine consumption and health of the participants after purchasing selected cannabis products from controlled cultivation under regulated conditions. 

Switzerland Approves Study Examining Effects of Controlled Purchases of Cannabis

On March 22, 2023, the Wine & Spirits Wholesalers of America (WSWA) announced their support of federal legalization and regulation of adult-use cannabis in a three-page letter addressed to members of Congress, including Speaker Kevin McCarthy, Leader Hakeem Jeffries, Leader Charles Schumer, and Leader Mitch McConnell (1). The WSWA is the industry trade group representing the distribution tier of the wine and spirits wholesalers in the United States (2).

Signed by WSWA President and CEO Francis Creighton, the letter explained how the regulation of alcohol could serve as a framework for cannabis regulation and how the current state-by-state approach to cannabis reform is unsustainable. Additionally, it called for the creation of a federal regulatory structure that licenses producers, testing facilities, and distributors in order to ensure product integrity, establish appropriate tax and trade practicerequirements, and protect public safety (1).

The letter highlighted the cooperation at the state and federal level after the end of Prohibition in the US. “During and immediately after Prohibition, a significant black market existed for alcohol products. It was cooperation between state and federal regulators that effectively ended that black market and created a legal alcohol marketplace that has evolved into the global standard for consumer safety, marketplace competition, and product diversification—all of which provide benefits to the public,” the letter said (1).



“States should maintain the flexibility to legalize—or not legalize—cannabis within their borders,” the letter continued. “They should also be able to regulate the production, distribution, and sale of the product in the manner that best suits each state—just as they do for alcohol. These regulations reflect local concerns but work under the same overarching federal regulatory framework for product manufacturing, testing and distribution, thereby ensuring a common foundation while each state remains the primary regulator of retail sales.”

The WSWA ended the letter with a list of the four pillars it decided should guide the federal regulation of cannabis (1):


1. The federal permitting of cannabis producers, importers, testing facilities, and distributors
2. Federal approval and regulation of cannabis products
3. Efficient federal tax collection
4. Effective federal guidelines and other measures to protect public health and safety

In 2021 WSWA drafted a policy brief laying out regulatory priorities that lawmakers should use when replacing cannabis prohibition with a legalization framework (3).

https://www.wswa.org/Letter-to-Congress-Urging-Federal-Legalization-%26-Regulation-of-Adult-Use-Cannabis

https://www.prnewswire.com/news-releases/wswa-announces-commitment-to-federal-legalization-and-regulation-of-adult-use-cannabis-301779500.html

https://www.marijuanamoment.net/major-alcohol-industry-association-calls-for-federal-marijuana-legalization-recommending-regulatory-framework/

In late March, the Wine & Spirits Wholesalers of America submitted a letter to congressional leadership expressing its support for cannabis legalization that uses regulatory frameworks similar to those of the alcohol industry.

An Alcohol Industry Trade Association Announces Support for Federal Legalization and Regulation of Adult-Use Cannabis

On March 20, 2023, the Colorado Department of Revenue and the Colorado Department of Public Health and Environment issued an advisory based on unacceptable levels of mold found in pre-rolls from MJ Durango LLC and flower from Carrick-Harvest LLC (Veritas Fine Cannabis) (1). MJ Durango worked with the state’s Marijuana Enforcement Division to issue a voluntary recall of its affected products, and the Department of Revenue advised that consumers who bought affected products from Carrick-Harvest LLC destroy or return them to the store they were purchased from (1, 2).

“The Colorado Department of Revenue (DOR), in conjunction with the Colorado Department of Public Health and Environment (CDPHE), is issuing a Health and Safety Advisory due to the identification of potentially unsafe levels of Total Yeast and Mold on Regulated Marijuana flower produced by Carrick-Harvest, LLC (doing business as Veritas Fine Cannabis),” read one of the notices (2). “The CDPHE and DOR deem it a threat to public health and safety when marijuana is found to have Total Yeast and Mold above acceptable limits established in Colorado Marijuana Rule 4-115.”

In the same week, the Arizona Department of Health Services (ADHS) reported that several cannabis companies issued a voluntary recall of various products over concerns of potential exposure to Aspergillus (3).

"ADHS Lab auditors found a possible Aspergillus contamination during a routine inspection of a marijuana testing laboratory where it was determined that equipment was misused according to the manufacturer," the ADHS stated (3). "Once ADHS discovered the potential contamination, the establishment involved took immediate action to work with all distribution and retail partners to remove any potentially impacted products."

The department listed the products affected and recommended anyone who purchased the products to dispose of them (3).

https://www.analyticalcannabis.com/news/colorado-regulator-issues-two-new-warnings-about-moldy-cannabis-products-314682

https://sbg.colorado.gov/sites/sbg/files/documents/230320_HSA_Carrick-Harvest.docx.pdf

https://www.azcentral.com/story/news/local/arizona-health/2023/03/21/marijuana-products-recalled-in-arizona-for-potential-fungus-contamination/70036090007/

Health and safety notices were issued in two states due to concerns about contamination exposure.

Regulators in Colorado and Arizona Issue Notices for Moldy and Unreliably Tested Products

In March 2023, a new piece of legislation was approved in the California Senate (1). The bill, SB-58 (2), legalizes possession of certain psychedelics and use of the substances. Senator Scott Wiener (D) refiled the bill back in December 2022, not long after an extensive version was halted in the last session. In its approval hearing, the Senate Public Safety Committee ratified the bill with a 3-1 vote. It will now head on to the Appropriations Committee.

Some of the psychedelics SB-58 legalizes are psilocybin, psilocyn, dimenthyltryptamine (DMT), ibogaine, and mescaline for either facilitated or personal use. Synthetic psychedelics such as lysergic acid diethylamide (LSD) and 3,4-Methyl​enedioxy​methamphetamine (MDMA) which is also known as ecstasy or molly, are not legalized in this bill but were originally included in the previous expansive bill. The new legislation also provides ““group counseling and community-based healing” involving the entheogenic substances (1).

“These are not addictive drugs. And these are drugs that have significant potential in helping people to navigate and to become healthy who are experiencing mental health challenges, substance use challenges,” Wiener mentioned at the approval hearing (1).

“We know that cities in California and elsewhere have passed resolutions to categorize enforcement of these particular criminal laws as the lowest law enforcement priority,” he said. “This is an important step for California. This is about making sure that people have access to substances that they need that are not addictive.”

A separate bill from Assembly member Marie Waldron (R) was introduced in February 2023 (1), with the goal to legalize psychedelics-assisted therapy for military veterans by allowing licensed clinical counselors to administer controlled substances (not limited to psilocybin, LSD, MDMA, ibogaine, and ketamine) to veterans for the treatment of post-traumatic stress disorder (PTSD), traumatic brain injuries, or addiction.

In regards to Wiener’s SB-58 bill, advocates are highly optimistic due to more time to consider the proposal from when it was first introduced and also the growing momentum behind psychedelics.

https://www.marijuanamoment.net/california-senators-approve-psychedelics-legalization-bill-in-committee/

https://leginfo.legislature.ca.gov/faces/billTextClient.xhtml?bill_id=202320240SB58

California Senate Public Safety Committee approves of SB-58, legalizing the possession and use of specific psychedelics.

Featured Content

The Agenda for Cannabis Science Conference Spring is Ready!

Update from the FDA: Not Adopting Existing Regulations for the CBD Industry

Check Out the Cannabis Science and Technology March Issue!

Share Your Work With Us and Help Educate the Cannabis Industry!

Ep 13: Psychedelic Science: Understanding Emerging Research and Potential Therapeutic Applications