The preventive controls for human food rule creates new requirements for covered domestic and foreign facilities producing human food to develop and implement a food safety plan based on hazard analysis and risk-based preventive controls. In general, the rule applies to facilities that have to register under section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). However, there are a number of exemptions and modified requirements that may apply (see 21 CFR 117.5 for exemptions that may apply to your facility).
If no exemptions apply to you, then you are required to have a PCQI develop and implement your facility’s food safety plan. A PCQI is a qualified individual who has successfully completed training in the development and application of risk-based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system. Job experience may qualify an individual to perform these functions if such experience has provided an individual with knowledge at least equivalent to that provided through the standardized curriculum.
