FSMA Guidelines for Cannabis Cultivators?
Few people doubt that the speed at which the cannabis industry is growing will continue. As Washington insiders discuss descheduling cannabis, cannabis banking reform, and even full legalization, it’s likely this pace will pick up in the not-so-distant future. With a burgeoning cannabis industry, the stage is set for an uptick in mergers and acquisitions. Even if you’re just starting out, you may be asking yourself what it takes for a company to be positioned for a sale. What if a buyer knocked on your door tomorrow? Do you have systems and controls in place that allow you to easily and adequately respond to a potential buyer’s due diligence questions? In a highly regulated industry, and particularly one with constantly evolving laws, rules, regulations, and guidance, it can feel daunting to build your business while simultaneously planning for a future sale that requires you to be proactive about establishing a compliance program. Here’s what you can expect.
By: Tucker Cole, WD Consulting
Cannabis companies create standard operating procedures (SOPs) to comply with state regulations and internal growing practices. These procedures typically include agricultural safety, recordkeeping, pest control, fertigation, harvest, post-harvest, storage, security, and transportation processes and controls. The problem is that each state has its own regulations. Streamlining all of these into federal guidance will be a challenge.
With Chuck Schumer’s recent statement that Congress will move forward to legalize cannabis, many are wondering what federal cannabis legalization will look like. The Path of least resistance and the easiest transition may be to follow FSMA guidelines.
What is FSMA?
The 2011 Food Safety Modernization Act (FSMA) was created to bring guidelines to food related growers, harvesters, agricultural transport, manufacturers, and packagers. Current Good Manufacturing Practices (cGMP) cannot be used in the growing portion of the supply chain, and FSMA acknowledges that cGMP is not practical in an active growing process. Rather, FSMA expands on Good Agriculture Practices (GAP), as laid out in the 2011 Produce GAP Harmonized Food Safety Standard, which makes more sense as it is better tailored for all growers whether outdoor, greenhouse, or indoor.
While many countries have implemented cGMP and GAP, FSMA acknowledges that cGMP is not practical, and GAP is not strict enough in an active growing process for food. To address this, the FDA developed the Preventive Control Rule (PC rule) and Produce Safety Rule (PSR), both within FSMA, which strengthened GAP to be better tailored for produce growers, or in this case cannabis growers.
The PSR and Modifying FSMA for Cannabis
There are at least five key requirement categories laid out in the PSR that would apply to federally sanctioned cannabis cultivation. The goal of these five requirements, which are listed below, is to improve safety protocols for the employee, company, and consumer.
1. Water for pre- and post-harvest
2. Biological soil amendments
3. Domesticated and wild animals
4. Worker training, health and hygiene
5. Equipment, tools, buildings and sanitation
Each required category has its own frequency and limits testing requirements. For example, water used for irrigation will have different testing requirements if sourced from a well or a pond. Water sourced from a pond will need to be tested for human pathogens more often and will have stricter limits. If a grower uses compost, required testing will ensure that human pathogens are within acceptable limits. Pests such as rats and rodents are addressed in the third requirement. The fourth requirement addresses when ill employees may be at work and when they may not be at work. Finally, the fifth requirement addresses sanitization. For instance, packaging equipment must be sterilized between batches and the company must maintain records to track the sterilization and sanitation process.
All cannabis products at every step in the production process are considered potentially hazardous. Using the five key requirements listed above will reduce those hazards and including them in a Safety Plan with SOPs ensures a safe product.
The PC Rule and Modifying FSMA for Cannabis
After the growing of cannabis, the PSR ends and the PC Rule begins. The PC Rule covers handling and packaging of produce, which for cannabis includes harvest, drying, curing and packaging. It also expands guidelines for processing, packaging and storing fresh produce or cannabis to minimize human pathogens such as Salmonella, Listeria, E. coli 0157:H7.
For packaging and processing of produce and likely cannabis, FSMA modified the Hazard Analysis Critical Control Point (HACCP). HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. HACCP is typically found in the beverage industry because of a critical control point or “kill point” such as pasteurization during bottling. For cannabis, however, there is no “kill point.” FSMA developed Hazard Analysis Risk Preventive Control (HARPC) for the PC Rule to give raw produce packagers or cannabis flower producers the ability to limit risk through science-based results. Cannabis cultivation mimics raw produce production and should use these modified rules.
In the manufacturing of cannabis products, such as vapes and foods, however, HACCP or GMP preventative control points will need to be in place. For example, vertically integrated companies will need to implement physical barriers between GAP-ending and GMP-starting activities to prevent contamination.
FSMA Will Likely Supplement, Not Replace, State Regulations
After federal legalization, FSMA or similar guidelines will regulate cannabis cultivation and processing, but it’s likely that federal regulations will be in addition to, rather than instead of state regulations, a model that is similar to the U.S. alcohol industry. For example, cleaning and sanitizing all food contact surfaces before and after an operation, wearing hair and beard nets correctly, dipping tools into Isopropanol and including recall plans are all examples of common sense preventative controls that will remain in place.
Documentation and Recalls
FSMA requires companies to include a recall plan as part of their safety plan. Documentation of controls for each batch is good business; having quantitative records will help your company reduce recalls and avoid costly litigation. Using packaging, sanitation, and other records will help companies in the supply chain prove they were in compliance and not a cause of potential outbreaks that resulted in a recall.
A formal recall plan provides guidance to you and your team should a health hazard outbreak occur. It details which team will evaluate the threat of the hazard to the public, how they will evaluate the threat, and what actions they will take depending on the result of the evaluation. Each type of hazard has a different danger level dictating whether the product is salvageable or needs to be destroyed. Not being ready for an outbreak can cause a large economic loss to the company, brand damage, or even bankruptcy. Not too long ago, a cannabis company had to recall a product, and their proactive recall was considered a positive action. They detected the hazard, had a safety and recall plan in place which kicked in before consumers were affected. Voluntary recalls are a good response to potential issues, however, correcting those flaws before they reoccur has to be at the top of the smart grower’s safety plan.
Whether or not FSMA will play a role in cultivation processes once cannabis becomes federally legal is to be determined, but in any case, well-developed state guidelines will continue to shape the industry. To be prepared, consider hiring a certified safety professional or a third-party company to develop and/or facilitate your company’s safety and recall plan. Compliance software such as ProCanna can be used to establish and schedule audits to help ensure your safety plan is being implemented on a day-to-day basis. It also ensures your safety plan stays up-to-date when regulations and guidelines change. And they will change. It is vital to be ahead of the game.
About Tucker Cole
Tucker Cole works with growers in the cannabis and hemp sectors to help make their production more efficient and profitable. He specializes in production planning, facility design, IPM and management skills to meet the individual needs of each of his clients. From his past involvement in the cannabis, ornamental and horticultural lighting industry, his experience provides growers with the knowledge they need to successfully produce their crops. Prior to forming his own consulting company, Tucker worked as an account executive for a greenhouse lighting company as well as a cultivation and production manager for several medical cannabis companies. Tucker is a graduate of the University of New Hampshire where he earned degrees in ornamental horticulture, sustainable agriculture, and food systems.