Brownie Mary meets 21 CFR Part 117

A large sector of the cannabis market is now edibles, which come in a myriad of products such as brownies, gummies and chocolates, to name a few. The facilities that produce the edibles now are much more complex than the kitchen Brownie Mary used back in the day in San Francisco. Residential and commercial kitchens are not considered compliant food manufacturing facilities according to the FDA, as stated in 21 CFR part 117. The detail and complexity of designing for food safety and drug manufacturing is defined by federal and international standards. To meet these standards, a bevy of process engineers, systems engineers, architects, specialty consultants, and material suppliers are regularly involved with every cannabis product manufacturing project.  

In compliant facilities there are strict protocols that are followed. For example, employees who move from a ‘dirty side’ (I.e., the entry, offices, breakroom, and bathrooms), to the ‘clean side’ (I.e., raw material handling, food manufacturing, packaging and storage) are strictly obliged to follow these protocols. Upon entry to a facility, workers are required to gown up, put on factory issued footwear, and change into scrubs. They don the required PPE, and then navigate all the safety and sanitary procedures and protocols.  These are all things Mary Rathburn never even considered doing in her kitchen! Note the bicycle seat pictured in the lower right foreground of the photo above, sorry Mary, not allowed! 

Also, in handling the plant material there are tight protocols from beginning to end of processing. For example, safety standards begin at the property line and include site design items such as exterior water management, trash dumpster locations, proper loading dock design, and rodent controls. Internal secure storage is maintained in controlled environments with temperature and humidity controls such as a vault. The zones where food, in this scenario infused edibles, are produced are separate and well controlled to minimize contamination. 

On top of all of that, there is commissioning, Total Quality Management (TQM), record keeping, and inspections among other requirements… at this point Mary has given up and is smoking a bong on the couch!