The Cannabis industry is in an interesting compliance position today and could change dramatically if the United States government legalizes it. Each state has their own rules about testing, traceability, and use of agricultural chemicals and then other countries have strict current Good Manufacturing Practices (cGMPs) rules in place. Cannabis is not the only industry with colliding regulations from country to country; the produce industry has similar problems country to country, however, within the US it has been standardized by the Food Safety Modernization Act (FSMA) passed in 2011. We could predict that regulations in the cannabis industry will mimic FSMA.
FSMA was created to bring guidelines to the produce food industry pertaining growers, harvesters, transportation, and packagers. They found it is tough to control human pathogens in a process with no kill step, for example lettuce cannot go through a sterilization or pasteurization step. In response, they developed the Preventive Control Rule (PC rule) and Produce Safety Rule (PSR) for the different links in the supply chain with science-based results. Although, where does this relate to the cannabis market if GMPs are already in place in some facilities? GMPs are not practical in an active growing process, but rather Good Agriculture Practices (GAPs) are tailored for the grower whether in the field, greenhouse or indoor.
In relation to FSMA, the PSR is based on GAPs and expanded on them to use science-based controls to minimize human pathogens such as Salmonella, Listeria, E. coli 0157:H7. There are 5 principles in PSR that can relate to cannabis growing, 1: water for pre and postharvest, 2: worker health, hygiene and training, 3: biological soil amendments, 4: domesticated and wild animals, 5: equipment, tools, buildings and sanitation. Each principle can have their own testing requirements on frequency and limits. For example, water used for irrigation will have different testing intervals if sourced from a well or a pond. Keep in mind a Reverse Osmosis system does not remove microorganisms completely.
Using the 5 principles in PSR, every step in the production process of fresh produce needs to be looked at as a potential hazard. This requires the grower to develop a Safety Plan. The safety plan creates standardize repeatable processes or SOPs to ensure a safe product. Companies in the cannabis industry have already created SOPs, however that is just 1 part in a safety plan. There is also Record Keeping, Pest Control – outside and inside of the facility, Crisis Management and Transportation Controls to name a few. A company’s safety plan needs to be well developed and tested. Though the PSR covers the growing and handling of fresh produce. There are another set of expanded guidelines for processing, packaging, or holding fresh produce.
During packaging and processing of produce FSMA provides the PC Rule using cGMP Hazard Analysis Risk-Based Preventive Control (HARPC) guidelines. These guidelines were modified from Hazard Analysis Critical Control Point (HACCP) because there is not a critical control point in fresh produce. HACCP is typically found in the beverage industry because of a critical control point or “kill point” such as pasteurization during bottling. There is not a kill point in today’s current production of smokable cannabis. In the manufacturing of cannabis products, such as vapes and foods, HACCP or EU-cGMPs will need to be in place. However, there needs to be a physical barrier between GAPs ending and cGMP starting if operating as a vertically integrated company.
Preventative control points in cannabis postharvest are a list of steps to lower the risk of contamination. Cleaning and sanitizing all food contact surfaces before and after an operation, wearing hair and beard nets correctly, and dipping tools into Isopropanol are all examples of preventative controls. A process such as the drying of cannabis to lower the water activity below microorganism activity could be considered a preventative control. This type of control also has a quantitative value to show in your records that a task was done correctly for each batch. Having quantitative records will help your company avoid recalls and litigation down the road.
Having a recall plan is imperative to a safety plan. If there is ever a problem with a product containing a health hazard, it is vital that your company is ready to take action. A recall plan consists of a team to evaluate the threat of the hazard to the public and what action is required. Each type of hazard has a different danger level dictating whether the product is salvageable or needs to be destroyed. There was a cannabis company that already had a recall, this should be considered a positive for the company because they saw a hazard and reacted to the problem and their safety plan worked before consumers were affected. Voluntary recalls should be considered a good response to your safety plan, though the next steps to correct those flaws are important.
Whether or not FSMA plays a role into the cannabis industry when it becomes federally legal, they are well developed guidelines for the industry to adopt in the meantime. A certified safety personnel should be hired to facilitate the safety plan, however there are third party companies that can help with the development of your safety program. These third-party safety companies can also set up audits to help make sure the safety plan has been developed correctly and make changes when the production and guidelines change. Regulations will change, it is vital to be ahead of the game.