Preventive Controls Overview
Under this rule, food facilities are required to establish a hazard analysis and risk-based preventive controls plan (HARPC), also known as a food safety plan, that identifies and analyzes potential hazards and specifies risk-based preventive controls that minimize or prevent identified hazards. Each HARPC plan must be developed by a Preventive Controls Qualified Individual (PCQI), defined as “someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system (FDA.gov),” and must be kept in the records of a given food facility.
Preventive Controls Deadlines
Different businesses face different deadlines for completing their HARPC plan. Compliance deadlines for most businesses have already passed. Very small businesses, defined as businesses with under 1 million dollars in average annual sales of human food or under 2.5 million dollars of average annual sales of animal food and businesses subject to the Pasteurized Milk Ordinance have until September 17, 2018 to comply. Generally, facilities that manufacture, process, pack, or store human or animal food for U.S. consumption are legally required or will soon be legally required to comply with this rule.
Preventive Controls Enforcement and Requirements
Most U.S. food importers must verify that their suppliers meet applicable FDA food safety requirements, including these Preventive Controls requirements. Therefore, a US importer may ask to review a supplier’s HARPC plan. In the event of an inspection, FDA is also likely to review a facility’s written HARPC plan.
Because developing a written HARPC plan is a complex and potentially time consuming endeavor, it is prudent for food businesses to begin developing their plans as soon as possible. It may also be prudent for businesses to seek assistance from professionals with specialized training in FDA regulatory compliance in order to ensure that their plans meet government standards.
