Business
Opinion: How data can raise confidence in cannabis mold testing methods
In 2023, more than 155 million Americans, nearly half the U.S. population, will live in one of the 39 states or Washington DC in which marijuana is legalized for medical use.
As demand for cannabis continues to trend upward, there’s been an increase of product cultivation to meet this growing demand, resulting in a correlating uptick in the volume of microbiology testing required to ensure product can be released into the market.
Cannabis is a high-maintenance, agricultural commodity with complex cultivation considerations.
If you’re involved in any part of the seed-to-sale process, you must anticipate that a portion of your product will fail state limits – the standard failure rate for the industry is 10%-20% of the product that is tested.
On the lookout for aspergillus
The most common cause of failure is high levels of fungal, or mold, contamination, specifically with a subset of aspergillus species, which is a known human pathogen.
The increase of the volume of testing in recent months has returned a corresponding rise of aspergillus detection among product sampling, resulting in a dangerous emerging narrative that the results are “false” positives, casting doubt on the validity of aspergillus testing methods as a whole.
The reality is that this false positive narrative is a mirage: Diagnostic data testing shows that the average positive detection rate for aspergillus maintains failure rates of 10%-20%, even as volume of testing increases.
The aspergillus mold is a primary focus for diagnostic testing in cannabis, as inhalation can cause infection – and even death – in immunocompromised or medical patients.
Aspergillus is everywhere and anywhere you go. The genus has more than 250 identified species and spores rapidly and easily dispersed through air, soil and water and, as a result, is highly present in the cannabis cultivation process.
Much of the current cannabis diagnostic testing conversation across the industry surrounds how the data collected can ensure confidence in testing methods and results while also providing a clear line of sight into process gaps that must be adjusted for.
Data tells the story
Diagnostic data collected from testing should tell a story that raises confidence in testing-method design and the validity of results.
If your failure rate is above 20%, this can likely be attributed to a gross failure of either the testing methodology or a significant breach of sanitary conditions in production.
In evaluating your testing methodology, the most important considerations include:
• Fit for purpose: There is a growing number of diagnostic testing solutions on the market as cannabis production fails.
Sometimes, even state-level remediation efforts allow for labs to retest samples on a different application, which can lead to result discrepancies.
It’s important for you to ensure that your testing method has been fit for purpose and designed for your specific lab – otherwise, you’re getting skewed results.
To explain this further – and with a cooking analogy – a deep oil fryer and air fryer return similar results in the kitchen, but the methodology in which they cook is different, requiring unique adjustments between these appliances to ensure a similar, but not exact, outcome.
This is the same in the cannabis testing field – you can’t simply run a sample on a secondary method that isn’t designed for your lab and have confidence in the results. The fact that the method is fit for purpose is essential.
• Access to peer-reviewed data: The backbone of the scientific industry is community collaboration to verify results. Your methodology should be peer reviewed in credible, third-party scientific journals for endorsement.
This peer-review process should include reference to the method’s specificity, or its ability to detect target strains and differentiate them from nontargets.
This testing includes both wet lab analysis and in silico analysis.
In silico, data is gathered in the method design process through computer simulations of the method’s targets against known databases of bacterial or fungal DNA to ensure consideration of the inclusion of the community’s collective knowledge base of the target organism(s).
You don’t have to be a scientist or microbiologist to understand the peer-reviewed process – when in the consideration stage, you can ask your testing partner directly for the peer reviewed data for your reference.
• Diagnostic collaboration: One thing always remains true – you can’t test your way into compliance.
Data is only as good as your plan of what to do with it, and you don’t have to tackle your process gaps alone.
Confidence in diagnostic testing is best achieved when there is a true collaboration between the method developer and their testing partner.
No method developer expects labs to understand everything about testing on their own.
Testing is a necessary and vital part of success in the cannabis industry, so look for partners that offer data analysis, remediation guidance, field visits and attention to your specific considerations to drive compliance within your existing process.
You must anticipate the common result of testing positive for aspergillus and have confidence in your testing method.
Given the nature of aspergillus, it’s best practice to assume that your aspergillus positives are true positives.
The best way to do this is to regularly review data to develop proactive plans to address gaps in your process to lower your failure rate to align with industry standards.
Pat Bird is the senior manager of scientific affairs at bioMérieux, based in Cincinnati, Ohio. He can be reached at patrick.bird@biomerieux.com.
Source: https://mjbizdaily.com/how-data-can-raise-confidence-in-cannabis-mold-testing-methods/
New Mexico regulators fined a cannabis operator nearly $300,000 and revoked its license after the company allegedly created fake reports in the state’s traceability software.
The New Mexico Cannabis Control Division (CCD) accused marijuana manufacturer and retailer Golden Roots of 11 violations, according to Albuquerque Business First.
Golden Roots operates the The Cannabis Revolution Dispensary.
The majority of the violations are related to the Albuquerque company’s improper use of BioTrack, which has been New Mexico’s track-and-trace vendor since 2015.
The CCD alleges Golden Roots reported marijuana production only two months after it had received its vertically integrated license, according to Albuquerque Business First.
Because cannabis takes longer than two months to be cultivated, the CCD was suspicious of the report.
After inspecting the company’s premises, the CCD alleged Golden Roots reported cultivation, transportation and sales in BioTrack but wasn’t able to provide officers who inspected the site evidence that the operator was cultivating cannabis.
In April, the CCD revoked Golden Roots’ license and issued a $10,000 fine, according to the news outlet.
The company requested a hearing, which the regulator scheduled for Sept. 1.
At the hearing, the CCD testified that the company’s dried-cannabis weights in BioTrack were suspicious because they didn’t seem to accurately reflect how much weight marijuana loses as it dries.
Company employees also poorly accounted for why they were making adjustments in the system of up to 24 pounds of cannabis, making comments such as “bad” or “mistake” in the software, Albuquerque Business First reported.
Golden Roots was fined $298,972.05 – the amount regulators allege the company made selling products that weren’t properly accounted for in BioTrack.
The CCD has been cracking down on cannabis operators accused of selling products procured from out-of-state or not grown legally:
- Regulators alleged in August that Albuquerque dispensary Sawmill Sweet Leaf sold out-of-state products and didn’t have a license for extraction.
- Paradise Exotics Distro lost its license in July after regulators alleged the company sold products made in California.
Golden Roots was the first alleged rulebreaker in New Mexico to be asked to pay a large fine.
Source: https://mjbizdaily.com/new-mexico-cannabis-operator-fined-loses-license-for-alleged-biotrack-fraud/
Four marijuana companies, including a multistate operator, have filed a lawsuit against U.S. Attorney General Merrick Garland in which they allege the federal MJ prohibition under the Controlled Substances Act is no longer constitutional.
According to the complaint, filed Thursday in U.S. District Court in Massachusetts, retailer Canna Provisions, Treevit delivery service CEO Gyasi Sellers, cultivator Wiseacre Farm and MSO Verano Holdings Corp. are all harmed by “the federal government’s unconstitutional ban on cultivating, manufacturing, distributing, or possessing intrastate marijuana.”
Verano is headquartered in Chicago but has operations in Massachusetts; the other three operators are based in Massachusetts.
The lawsuit seeks a ruling that the “Controlled Substances Act is unconstitutional as applied to the intrastate cultivation, manufacture, possession, and distribution of marijuana pursuant to state law.”
The companies want the case to go before the U.S. Supreme Court.
They hired prominent law firm Boies Schiller Flexner to represent them.
The New York-based firm’s principal is David Boies, whose former clients include Microsoft, former presidential candidate Al Gore and Elizabeth Holmes’ disgraced startup Theranos.
Similar challenges to the federal Controlled Substances Act (CSA) have failed.
One such challenge led to a landmark Supreme Court decision in 2005.
In Gonzalez vs. Raich, the highest court in the United States ruled in a 6-3 decision that the commerce clause of the U.S. Constitution gave Congress the power to outlaw marijuana federally, even though state laws allow the cultivation and sale of cannabis.
In the 18 years since that ruling, 23 states and the District of Columbia have legalized adult-use marijuana and the federal government has allowed a multibillion-dollar cannabis industry to thrive.
Since both Congress and the U.S. Department of Justice, currently headed by Garland, have declined to intervene in state-licensed marijuana markets, the key facts that led to the Supreme Court’s 2005 ruling “no longer apply,” Boies said in a statement Thursday.
“The Supreme Court has since made clear that the federal government lacks the authority to regulate purely intrastate commerce,” Boies said.
“Moreover, the facts on which those precedents are based are no longer true.”
Verano President Darren Weiss said in a statement the company is “prepared to bring this case all the way to the Supreme Court in order to align federal law with how Congress has acted for years.”
While the Biden administration’s push to reschedule marijuana would help solve marijuana operators’ federal tax woes, neither rescheduling nor modest Congressional reforms such as the SAFER Banking Act “solve the fundamental issue,” Weiss added.
“The application of the CSA to lawful state-run cannabis business is an unconstitutional overreach on state sovereignty that has led to decades of harm, failed businesses, lost jobs, and unsafe working conditions.”
Alabama regulators are targeting Dec. 1 to award the first batch of medical cannabis business licenses after the agency’s first two attempts were scrapped because of scoring errors and litigation.
The first licenses will be awarded to individual cultivators, delivery providers, processors, dispensaries and state testing labs, according to the Alabama Medical Cannabis Commission (AMCC).
Then, on Dec. 12, the AMCC will award licenses for vertically integrated operations, a designation set primarily for multistate operators.
Licenses are expected to be handed out 28 days after they have been awarded, so MMJ production could begin in early January, according to the Alabama Daily News.
That means MMJ products could be available for patients around early March, an AMCC spokesperson told the media outlet.
Regulators initially awarded 21 business licenses in June, only to void them after applicants alleged inconsistencies with how the applications were scored.
Then, in August, the state awarded 24 different licenses – 19 went to June recipients – only to reverse themselves again and scratch those licenses after spurned applicants filed lawsuits.
A state judge dismissed a lawsuit filed by Chicago-based MSO Verano Holdings Corp., but another lawsuit is pending.
Source: https://mjbizdaily.com/alabama-plans-to-award-medical-cannabis-licenses-dec-1/
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