Experts Claim Proposed Californian Cannabis Regulations Could Put Medical Cannabis Users at Risk of Infection
On July 13, the Bureau of Cannabis Control (BCC), which regulates medicinal and commercial cannabis in California, proposed a new list of state regulations, which cover a huge range of licensing and safety issues. Industry experts were however surprised to see that these proposals do not include a requirement for a Total Yeast and Mold Count (TYMC). The lack of this criterion means that cannabis products heavily contaminated with fungi and fungal toxins could potentially pass testing and make it on to the market. Ignoring the advice of the California Cannabis Industry Association’s (CCIA) Quality Control Committee (QCC), the BCC’s proposal instead favors strain specific testing using PCR-based methods. This screening method is inherently far more focused than TYMC and as such can miss contamination from fungi that are not included in the target list.
Through conversation with CCIA members, Analytical Cannabis have learned that the lack of a TYMC requirement could put users at risk of infection.
The proposals were posted to California’s Cannabis Portal on July 13, beginning a 45-day public comment period which will end on August 27. If no significant counterarguments are made within this period, experts argue that the safety tests for Californian cannabis will be inadequate and leave patients at risk of infection from contaminated cannabis.
The roles of the BCC and CCIA
The BCC is the lead agency responsible for developing regulations for medical and adult-use cannabis in California. As a state regulator, the BCC is responsible for licensing retailers, distributors, testing laboratories and microbusinesses in California.
Acting as a form of accountability, the CCIA was set up to help educate the BCC and other regulators and lawmakers on cannabis research and policy. As one strand of this education, the CCIA’s QCC focuses on the practical application of regulations as they pertain to cannabis testing labs and offers insights into best practices for quality control issues.
However, in the incidence of a TYMC requirement, the BCC has ignored the CCIA’s advocacy and pushed ahead with the new proposals.
Dr Reggie Gaudino, Member of the CCIA’s Board of Directors, Co-Chair of the QCC, and Chief Science Officer at Steep Hill, Berkeley, CA, told us: “In my opinion, there is a disconnect between the QCC, the BCC, and CA state cannabis regulations regarding TYMC requirements, or lack thereof. Steep Hill and several other labs certainly feel, to some degree scientifically compromised, when adhering to the current microbial testing regulations that allow flower with 25% visible mold to enter the market.”
Why is TYMC important?
Yeast and mold are fungi that can be found in the air, water, soil, vegetation and in decaying matter. Whilst the clear majority of these species are harmless to humans, certain fungi produce fungal growth by-products known as mycotoxins, which are toxic to humans and animals. For most people, these toxins aren’t life-threatening and recovery is typical with appropriate clinical care, but for those with weak immune systems, such as HIV patients or the elderly, the result can be more severe.
“Strain-specific testing is fine because you want to ensure that immune-compromised patients are not exposed to specific strains that are known to cause illness and even death,” says Arthur de Cordova, member of the CCIA’s QCC and Managing Director of Ziel, a company that provides radio frequency-based remediation solutions for cannabis cultivators.
As de Cordova highlights: “There’s no real issue with requiring strain-specific testing; it’s the lack of a TYMC which is troubling the CCIA."
“The view of the BCC is ‘fine; you want to do strain-specific testing, we endorse that. But by not having a TYMC test in there, you are creating a situation where you could have a product with a lot of mold on it coming from a cultivator and making it onto the shelf for patients.”
Dr Gaudino adds: “We know that without TYMC, we are passing product that, we ourselves wouldn’t want to go near, yet because we operate under the regulations of the BCC, are required to do so.”
Moreover, it’s not even as if the presence of yeast and mold is invisible. Colony forming units (CFUs) of fungi can become so abundant that mold can cover and deteriorate a cannabis product just as it can spoil food, but yet those products could still pass screening under the new proposals.
“TYMC is an industry standard in many other industries like the food industry because it is a broad test. The current regulations are species specific which has proven to be a loophole since we have found incubated products covered in what appears to be mold but pass the compliance test requirements. I even have pictures! This is a huge risk to consumer safety.” Said Dr Swetha Kaul, another member of the CCIA’s Board of Directors, Co-Chair of the QCC, and Chief Scientific Officer at Cannalysis.
In a letter addressed to the Chief of the BCC, Ms. Lori Ajax, Dr Gary Ward, Chief Compliance Officer, PacLab Analytics and member of the CCIA’s QCC expressed his concerns. “The emergency regulations, as well as proposed final regulations, do not protect the health and safety of Californians. I have seen cannabis pass the current microbial impurities test while being visibly covered with mold and fungi. Species-specific mold testing simply does not provide a safe enough benchmark by which to assess microbial growth.”
Joseph Tuscano, Professor of Internal Medicine, UC Davis discusses their study that identified infection-causing mold and bacterial contaminants in Californian cannabis samples.
Furthermore, Dr Ward cites a 2017 UC Davis study in which “… 20 marijuana samples obtained from Northern California dispensaries were found to contain several yeast and mold species, including Cryptococcus, Mucor, Aspergillus fumigatus, Aspergillus niger, and Aspergillus flavus as well as Klebsiella pneumoniae and Acinetobacter baumannii bacteria.” Mucor, for example, can cause fever, vision problems, facial pain and shortness of breath amongst many other things. Whilst Cryptococcus can cause pneumonia-like illness, skin lesions and even meningitis.
And there’s another facet to this story, one unique to the cannabis environment of California. Yeast and mold can be more problematic for outdoor cannabis growers who have to contend with the wide range of fungal species in the environment. As a state known for its wide use of outdoor cannabis production, the presence of mold and yeast is a pertinent issue for Californian regulators.
De Cordova added: “In California, we have a lot of outdoor growers, where there’s a greater exposure to mold. A no-TYMC rule means that these growers may be able to get product to market that would otherwise fail testing.”
What comes next?
Dr Gaudino shared his opinion: “I would suggest that the BCC welcome open dialogue and transparent discussion with the QCC of CCIA and utilize the many, well-versed scientists in the industry to incorporate a set of safety standards, including TYMC, that will do their best to protect the most susceptible medicinal users and overall public health.”
At this stage, the new regulations are still just proposals. Over the month, the BCC will be holding public hearings where individuals may present counterarguments. These hearings are set to take place across California on August 7, 14 and 27. Further information can be found here.
To safeguard the immune-compromised cannabis users of California, any objections to the proposals will have to be made before August 27. On their part, the CCIA has recommended a standard TYMC count of 10,000 CFU per gram, which others may champion.
“We need to add standard tests such as TYMC and Total E. coli/Coliforms and APC counts – all of which are standards from other industries”, says Dr Kaul.
Dr Gaudino finished up by adding: “It is becoming apparent that changes need to be made. If we truly want to be able to have a safe product for all, it might be time to acknowledge that there is not a "one size fits all" mindset that can ensure the safety of product – any product – not just flower, for all end users. We also need to consider that it will take increased costs (for labs and cannabis-producing businesses) to deliver on rigorous testing standards that will be passed on to the end user.”
Following these hearings, the Bureau may then consider any arguments and modify the proposals. Regardless, the final proposals will then be publically available for 15 days prior to adoption.
When contacted to discuss the issues highlighted in this article the BCC declined the opportunity to comment.