GMP Compliance Is Key to Edibles Food Safety
With the passage of the Food Safety Modernization Act in 2011, revised Good Manufacturing Practices (GMPs) became law for food production facilities. While cannabis edibles are not yet subject to federal regulation, compliance with GMPs is critical for food safety.
The current GMPs consist of several different sections: Personnel, Plant and grounds, Sanitary operations, Sanitary facilities and controls, Equipment and utensils, Processes and controls, Warehousing and distribution, Holding and distribution of human food by-products for use as animal food, and Defect action levels. The requirements are purposely general to allow individual variation by manufacturers to implement the requirements in a manner that best suit their needs.
Although a food-production business can be GMP certified (such as through a GFSI scheme), well-known certifying groups are keeping their distance from cannabis. This is due, at least in part, to the continuing lack of federal legality of cannabis; once that is changed, we are likely to see these certifying bodies getting more involved. Some cannabis-specific GMP certifications are starting to emerge, but the jury is still out on whether or not they are credible or meet the high standards that they should. So, for now, companies should be giving a hard look at any cannabis certifications to evaluate the rigor of the standard and the actual benefit/value they may provide. Some of them may eventually demonstrate their strength, or the already existing, well-known GFSI schemes may become more willing to work with the cannabis industry. Until then, however, you can significantly improve the food safety of your edibles by creating GMP compliant programs.
So, what does that include? In brief:
GMPs for human food, as published in Title 21 of the Code of Federal Regulations, Part 117 Subpart B describe the methods, equipment, facilities, and controls for producing processed food, and are the minimum sanitary and processing requirements for producing safe and wholesome food.
Personnel. Delineates plant and employee responsibilities with regard to personal hygiene, cleanliness, apparel, hairnet and glove use, eating and smoking restrictions, etc. It also discusses the need for food safety education, training, and supervisory personnel to ensure compliance.
Plant and grounds, Sanitary operations, and Sanitary facilities and controls. Outlines requirements for the maintenance, layout, and operations the facility (including maintenance of the exterior) to ensure it is designed and built to reduce the potential for contamination. Although largely focused on the end result of a sanitary facility, some detail is provided on how to achieve this, i.e., protecting against food contamination through the sanitation of the facility, equipment, and utensils; safe storage of cleaning and toxic materials; pest control; food contact surface cleaning; and cleaning frequency. There also are specifications for adequate sanitary facilities and controls, including the water supply, plumbing, toilet and handwashing facilities, and rubbish and offal disposal. Because this section holds requirements for the conditions of the facility rather than the food itself, it means that instead of having to prove that the food is adulterated, insanitary conditions are considered sufficient to show that a food might have become adulterated.
Equipment and utensils. Describes the requirements and expectations for the design, construction, and maintenance of equipment and utensils so as to ensure sanitary conditions. It also has the requirement for an automatic temperature control or alarm system to alert employees to a significant change in temperature.
Process and controls. Lists the general sanitation processes and controls necessary to ensure that food is suitable for human consumption. It covers many aspects not discussed in previous subparts and addresses the monitoring of physical factors (critical control points), such as time, temperature, humidity, pH, flow rate, and acidification.
Warehousing and distribution. Includes requirements for warehousing and distribution, requiring that finished foods be stored and distributed under conditions that protect against physical, chemical, and microbial contamination, and that the container and food be protected from deterioration.
Holding and distribution of human food by-products for use as animal food. While not applicable to cannabis manufacturers, this section addresses how human food byproducts should be held and stored to protect food meant for animal food from contamination, and includes labeling and identification provisions.
Defect Action Levels (DALs). The last subpart of the food GMPs allows FDA to define maximum defect action levels (DALs) for a defect that is natural or unavoidable even when foods are produced under GMPs. Generally, the defects (including rodent filth, insects, or mold) are not hazardous to health at low levels. The DALs are defined for individual commodities and manufacturers are expected to use quality control operations that reduce defects to the lowest possible levels. Those exceeding maximum DALs are considered adulterated and cannot be blended with other food.
In general, compliance with GMPs shows that the facility is abiding by the principles of food hygiene and food safety, including the importance of employee health and personal hygiene, and many companies see GMPs as the foundation of other quality programs, such as HACCP and GFSI and ISO standards. Because of this, along with the fact that, in all likelihood, cannabis edibles will eventually be under the oversight of a federal food agency – and the overarching goal to protect your consumer – it is important to ensure your GMP program is thorough and in compliance with current GMPs. Our expert HashTAG team can help you get your program started, or assess what you have for food safety and compliance.