Hazard Analysis and Risk-Based Preventive Controls (HARPCs) comprise the bulk of regulations imposed under the FSMA Preventive Controls Rule. Facilities subject to HARPC requirements must create a food safety plan, administered by a “preventive controls qualified individual,” or PCQI.
- Preventive Controls Qualified Individual: 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 is otherwise qualified through job experience to develop and implement a food safety system.
This food safety plan must contain:
You should identify and evaluate “known or reasonably foreseeable” hazards for each type of food handled. This must include an evaluation of the likely severity of complications from these hazards, as well as an assessment of the risk of these hazards pose if preventive controls are not in place. A hazard analysis will likely include considering hazards which are both naturally occurring and unintentionally introduced by factory conditions: examples of relevant hazards include human pathogens, pesticides, and broken glass.
You should employ risk-based, reasonably appropriate procedures and practices that a person knowledgeable about the safe manufacturing, processing, packing, or holding of food would employ to significantly minimize or prevent the hazards identified under the above hazard analysis that are consistent with the current scientific understanding of safe food manufacturing, processing, packing, or holding at the time of the analysis. An example of a preventive control for mitigating human pathogens would be an employee health and hygiene training program conducted and documented on a regular basis.
Preventive Controls Management
You should create written management plans, including the monitoring processes of preventive controls, the frequency at which they are being performed, a process for documentation and monitoring, corrective action processes to mitigate food safety risks, and verification processes to ensure the consistency and quality of preventive controls.
Supply Chain Programs
If your facility receives raw materials or ingredients from other suppliers, you need verification that suppliers are taking necessary steps in preventive controls and documentation. Facilities may only source raw materials or ingredients from “approved suppliers,” which is defined as suppliers which you have identified as using requisite preventive controls and documentation. To approve suppliers, facilities can take steps including the review of supplier documentation and ingredient testing. If identified potential supplier hazards involve a reasonable risk of serious illness or death, then receiving facilities must conduct onsite audits or review recent third-party audit documentation before accepting ingredients, and annually afterwards. Note that if suppliers are qualified facilities, or exempt/qualified exempt from the Produce Rule, then these standards may be limited to examining past compliance history of suppliers. The National Sustainable Agriculture Coalition outlines the following scenarios relating to supply chain programs for farms.
Note that this section would not apply to a farm, for example, making fresh salsa from the farm’s own produce. If, however, the farm sources tomatoes for the fresh salsa from another farm, then the supply chain program would be required. If the farm sources tomatillos for salsa, then it likely would not need the supply chain program because the farm making the salsa would be cooking the tomatillos. Therefore, it is up to that farm to significantly minimize any hazards associated with the tomatillos by properly cooking them.
If, for example, a food hub is sourcing carrots and peeling them to be eaten raw, then the supply chain program would be required, assuming the food hub is fully subject to the Preventive Controls Rule. If the food hub was only sourcing and peeling produce that was then treated with a “kill step” (e.g. winter squash or potatoes, which must be cooked before eating), then the food hub would not have to implement the supply chain program component of the HARPC requirements.
This rule will continue to evolve as the FDA develops new guidance and responds to input from the private sector. For a more in-depth summary of what the Preventive Controls Rule means for farms, reference Understanding FDA’s FSMA Rule for Food Facilities created by the National Sustainable Agriculture Coalition.
We hope this guide helped to prevent any confusion surrounding the Food Safety Modernization Act and your firm!