Exploring the Second Building Requirement for Edible Cannabis Manufacturing.
Canada has proposed a full prohibition on manufacturing edible cannabis in a facility that is manufacturing conventional (non-cannabis) products. It is proposed that manufacturing could be at the same site, but not the same building.
This proposal could be one of the costliest declarations to industry yet. The requirement to build a separate physical building with infrastructure, systems and personnel to support it will be cost prohibitive, especially for small players in the industry. It certainly derails industry plans to add cannabis lines to existing, sometimes underutilized food manufacturing sites and takes small bakeries out of play completely.
The RIAS (Regulatory Impact Analysis Statement) is an estimate of the costs and benefits in financial terms, to the changes that are proposed and was published with the Proposed Regulations. But this separate building requirement is one area where Health Canada has not ventured to put a dollar value on the costs, they simply state “It is anticipated that this proposed requirement would impose an incremental cost on licensed processors; however, Health Canada does not have the data necessary to quantify this cost at this time.” The savings to the industry includes administrative costs and the $250 fee to apply SFCR (Safe Food for Canadians Regulations) licence. A small amount compared to the cost and ongoing operational costs for a separate building.
Yet, this concept is not new for food safety. In the food industry separate buildings is common for nut-containing products; allergen control practices within facilities is paramount to a safe food supply for a large portion of the population with allergies. A similar line of thought in pharmaceuticals came about for penicillin products which must be manufactured in separate facilities. When setting these rules, the government looks at potential harm by a cross contamination event. Sometimes it is too great for regulators to consider any other manufacturing scenario than separate buildings – trying to drive the risk to zero.
Now, I don’t think we can compare cannabis to an allergen, or the very light and fluffy airborne penicillin handling, but being a controlled substance on the international stage means we cannot have it unintentionally entering our food system – ever! To most of the world, it is not a food ingredient and should not be in food manufacturing plants. The international implications of a single cannabis cross contamination incident are far too great for the Canadian food industry and our export market.
When we as an industry are ready, there are alternatives.
The proposed regulations place the manufacturing of edible cannabis under the Standard Processing licence and no licence is required under SFCR. This singular licensing requirement is good news for ease of entry in one regard, but this effectively imposes the quality management system of GPP (Good Production Practices) for edible cannabis product. The proposed regulations do improve GPP by introducing some concepts from SFCR requirements, but it doesn’t go all the way. GPP is not that high of a quality standard, it is a new standard introduced for cannabis by the Canadian government. It doesn’t exist in the rest of the world and it’s certainly not trusted by other regulators for food manufacturing.
If dual licensing was an option, a site with current SFCR and Good Manufacturing Practices could add on a Processor License and be dual regulated. Yes, the $250 burden will be there and additional inspection costs, but then it upgrades the quality standards by which these products are manufactured and ensures that cross contamination is challenged during inspection. Think of the established food and beverage manufacturers with robust, time proven quality management systems, cleaning validation and process and an established track record. Under dual licensing, they would be able to enter edible cannabis space in their existing buildings. This may still be prohibitive to small players, but it is one option to allow cannabis and non-cannabis foods at the same site.
If the main reason for implementing this requirement is for the international market, then smaller producers only distributing in Canada could also be given the authorization to manufacture cannabis and non-cannabis food products. This scenario would help the small bakery in town, or the café that bakes their own goods be a viable business.
At the end of the day, product cross contamination is unintentional and labeling mix ups are just that-mix ups. They happen because humans are running these plants and prevention controls are never 100%, they are only preventative. The building restrictions presently make sense, because the industry isn’t ready for it from a quality management system perspective, but more importantly, the world isn’t ready for it from a trust perspective. What Canada is doing is a grand social experiment and we don’t have a track record yet. But once we do, look-out: Hello world, would you like to try our brownies?!
Cannabis Compliance Inc. is well positioned to help the edible cannabis industry enter the market. Submission of Standard Processor applications, preparation of your Preventive Control Plan (PCP) and personnel training are key to entering this new space. We have the cannabis and food experts to help you move forward. Contact us today! Karina Lahnakoski, Vice President, Pharmaceutical Cannabis Services