FSMA Merges with Your Food Safety Program

The food safety plan must be developed and/or overseen by a preventive controls qualified individual (PCQI). The PCQI is a person who, through proper training and job experience, is thoroughly qualified to develop, implement, and maintain a food safety program. The PCQI is directly responsible for the development of the food safety plan, overseeing the validation of the established preventive controls, and performing record reviews of the food safety plan documentation. This role is now required through FSMA.

The food safety plan is in many ways similar to the development of a Hazard Analysis and Critical Control Points (HACCP) plan which includes conducting a thorough hazard analysis to identify all potential biological, chemical (including radiological), and physical hazards associated with each step in the process. These hazards may be naturally occurring, unintentionally introduced, or intentionally introduced for economic gain. The primary difference between HACCP and the PCHF plan is that in HACCP, critical limits are mandatory only at CCPs whereas preventive controls include implementing control limits at CCPs and/or at any other point in the process where controls are appropriate for food safety. Preventive controls must be established for each identified hazard to ensure it will be minimized or prevented.

Much like CCPs in a HACCP plan, each preventive control must have established corrections and documented corrective action procedures that prevent the food from entering commerce. Preventive controls must also be routinely monitored and verified as effective. Verification activities may include product testing and environmental monitoring for pathogens or indicator organisms, but only as deemed appropriate to the nature of the food and the preventive control. For example, environmental monitoring would be required if contamination of a ready-to-eat food with an environmental pathogen is a hazard requiring a preventive control. Lastly, the rule mandates that certain preventive controls, like CCPs, be scientifically validated to ensure that they are adequate to control the hazard.

It is important to note that the PCHF Final Rule mandates preventive controls be developed for four elements of the food safety plan: food allergen controls, sanitation controls, the recall plan, and the supply chain program. However, these four programs do not need to be validated. Other preventive controls may not require validation either if the PCQI provides documented justification that validation is not applicable based on the hazard and its corresponding preventive control.

In August 2016, the PCHF draft guidance for the industry was published. It is a work in progress but provides good insight on the agency’s current thinking on how to approach implementation of the regulations. Overviews of the remaining six FSMA rules will be covered in the final article of this series, which will be included in the April/May Food Quality & Safety issue.

Thoma, a food safety and quality professional with nearly 20 years of experience in food manufacturing and food safety auditing, has worked for NSF International for four years as both a GFSI certified auditor and as a technical specialist in the Supply Chain Food Safety group. Reach her at [email protected].