Assuring cannabis quality through packaging, risk control, and analytical testing
Testing improvements, risk-based controls and packaging clarity are just some of the improvements that the C-45 Quality Association would like to see Health Canada address.
June 8, 2022 By Tom Ulanowski (on behalf of the C-45 Quality Association Board of Directors)
In March 2022, Health Canada announced several proposed changes to Canada’s Cannabis Act and Regulations.
Several of these changes, including modifying the dried cannabis equivalency for beverages, streamlining some aspects of non-therapeutic research on cannabis, and improvements to the analytical testing program were issues that the C-45 Quality Association Board of directors have raised and brought to the attention of Health Canada on behalf of our members.
While these proposed amendments represent only a small portion of the necessary regulatory improvements that our Association has been advocating for, these changes nonetheless represent a positive step forward for the industry and a willingness by the regulator to listen to stakeholders.
However, there are many other regulatory issues our membership continues to raise. Among those are concerns with how analytical testing is conducted, simplifying or streamlining monthly reporting requirements, providing clarity and creating permanent flexibilities around packaging date requirements and authorizations for qualified staff, and moving to more of a risk-based model of control for cannabis products.
Analytical testing concerns and improvements
There has been ongoing concern expressed by our membership about the trend of “lab shopping” by some licence holders in seeking out testing labs that will provide more favourable results, especially when it comes to high THC levels.
More oversight of licensed analytical testing laboratories—and sampling procedures by licence holders — is needed to ensure that sample preparation, reference standards and analytical methodologies are appropriately validated for consistency between labs. For dried cannabis, moisture content analysis should be performed alongside cannabinoid testing to eliminate the potential for potency inflation from over-drying samples (since potency must be reported on an “as-is” moisture basis).
In addition, the C-45 Quality Association feels that inspections of analytical labs should be carried out by Health Canada officers who have the education, technical knowledge, and experience with the methods, reference materials used in validation and analytical instrumentation they would be inspecting. Statistical analysis of cannabinoid potency results issued by testing labs is another very powerful tool that could be employed by the regulator to identify anomalies and potential inter-lab bias.
We also believe that the requirement for pesticide testing should be eliminated for cannabis that is processed (i.e., extracted) for research and development purposes. Pesticide screening is expensive, and non-commercial products do not pose a risk to public health, as they are not intended for consumption.
Risk-based controls for cannabis products
The C-45 Quality Association would also like to see Health Canada move to risk-based controls for cannabis products rather than treating all products the same way. For example, a package of dried cannabis containing predominantly THCA (the non-intoxicating form of THC) requires the same child-resistant packaging as a cannabis extract or edible, which mostly contains THC. Packaging requirements for products should be proportional to risk.
In addition, we continue to urge Health Canada to consider dosage increases for edibles beyond the current 10 mg THC limit, or at least allow for more than 10 mg THC per package (while maintaining 10 mg maximum per unit).
Another regulatory improvement that we continue to advocate for is reforming the existing Notice of New Cannabis Products (NNCP) process. Currently, licence holders must provide detailed information on every new cannabis product SKU at least 60 days prior to selling the product. A new NNCP submission is required even if the name or net weight of a product is slightly modified after initial submission.
We believe that the NNCP process can be significantly improved by eliminating the requirement to submit a notice for standard product formats (dried cannabis or inhalable cannabis-only extracts) or product-line extensions for previously submitted products.
Currently, there is no guidance for “packaged on” dates (a required piece of information on every cannabis product), which is contributing to inconsistent practices across the industry.
Some licence holders define it as the filling date, while others utilise the date when the final packaging is completed. Provincial wholesalers and consumers make purchasing decisions based on their own interpretation of the packaging date.
We believe that clarity to this labelling requirement is necessary. Further, our Association welcomes the recent extension to COVID-related packaging date flexibilities, and supports making those changes permanent.
Monthly CTLS reporting
Monthly cannabis reporting requirements are another area that can represent a significant regulatory burden for many in the industry, and one that our Association feels can be more reasonably streamlined while still ensuring the necessary information is provided to the regulator in a timely manner.
A few examples members have raised are the time-consuming inventory-type tracking within a facility, such as counting vegetative and flowering plants on a monthly basis. This is a very low-risk issue in terms of security compared to finished cannabis products, and has the opportunity to free up resources for licence holders.
Qualified staff flexibilities
The compliance requirements of onsite Security Clearance Holders (SCH) need provisions for operational redundancies and enabling supervised duties for remote working. The current responsibilities of an SCH can be incredibly onerous and time-consuming. Allowing QAPs, for example, to delegate some responsibility to qualified colleagues would mitigate burnout that many SCHs and Key Persons currently experience.
While the industry still has a way to go in terms of working as an efficiently regulated program, the C-45 Quality Association is pleased to see that Health Canada is listening to the concerns of industry, and is open to providing solutions based on stakeholder feedback.
Tom Ulanowski is the chair of the C-45 Quality Association (c45association.com).
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