The Food Safety Modernization Act, which was signed into law by President Obama on January 4, 2011, promised sweeping reform of food safety practices from farm to fork, and shifted FDA’s regulatory posture from reacting to food contamination to proactively preventing it. While the Trump administration has vowed to eliminate two regulations for every new regulation, at this year’s Food and Drug Law Institute’s Annual meeting, Dr. Susan Mayne, the Director of FDA’s Center for Food Safety and Applied Nutrition, made clear that FSMA is the law of the land and FDA fully intends to continue its implementation and enforcement of it.
FSMA mandates that facilities that manufacture, process, pack or hold human food implement a written food safety plan focused on preventing hazards in foods. This plan involves:
- An evaluation of known or reasonably foreseeable hazards that could impact food safety including: biological hazards, chemical (including radiological) hazards, physical hazards, and hazards that may be intentionally introduced for purposes of economic gain;
- An assessment of the hazard, which includes an evaluation of the severity of illness or injury if the hazard were to occur and the probability that the hazard will occur in the absence of preventive controls;
- The identification of what preventive steps or controls will be put into place to significantly minimize or prevent each hazard;
- The specification of how the facility will monitor the preventive controls to ensure that they are effective;
- The maintenance of records of the monitoring;
- A written supply-chain program for those ingredients the receiving facility has identified as a hazard requiring a supply-chain applied control; and
- The recall plan.
Agency investigators are already out conducting modernized current good manufacturing practice inspections and full preventive control inspections. In evaluating new procedures, FDA expects that businesses have made a good faith effort to comply with FSMA. Consistent with FSMA’s intensive documentation requirements, Dr. Mayne emphasized that FDA inspections will target facility records. As such, manufacturers should have in place a thorough recordkeeping system demonstrating training, redundancy in the food safety plan, and a proactive effort to identify safety issues and prevent food contamination.
FSMA gives FDA broad authority to access records during routine inspections and without cause. These records should be accurate, detailed, and comprehensive. Companies have spent countless hours and resources to ensure that preventive processes have been developed and implemented in accordance with FSMA’s requirements. However, when the FDA knocks on the door of your food facility, a successful inspection will depend on having ready thorough documentation to demonstrate that effort.