Over the last decade, high-profile outbreaks of foodborne illness and data showing that such illnesses strike almost 20% of Americans each year have caused a widespread recognition that we need a new, modern food safety system. The FDA Food Safety Modernization Act (FSMA) was signed into law by President Obama on January 4, 2011 and it is the most sweeping legislation for regulating the food industry in over 70 years. It aims to ensure the US food supply is safe by shifting the focus of federal regulators to be proactive rather than reactive, from responding to outbreaks to preventing food safety problems before they occur.
The requirements for preventive controls for food include current good manufacturing practice and hazard analysis and risk-based preventive controls, which would apply to many domestic and foreign firms that manufacture, process, pack, or hold food. These firms would be required to evaluate hazards, identify and implement preventive controls to address these hazards, verify that the preventive controls are adequate to control the hazards identified, take corrective action when needed, and maintain a written plan and documentation. It is clear that the need for high-quality scientific data collection and management will intensify as these evaluations and subsequent control policies are contemplated. Because the decision to release foods to the marketplace will be made on the basis of hazard identifications and controls, the need for data of known quality and statistical power is obvious. A data quality program to support these needs will include statistically-informed sampling design, coupled with more rigorous protocols and uncertainty analysis. Data validation and performance evaluation studies for contract and internal laboratories are important tools to gain control of the overall analytical process.
The proposed rule also contains requirements relating to auditing and certification of food facilities and food under the program and for notifying the FDA of conditions in an audited facility that could cause or contribute to a serious risk to the public health. To ensure the safety of food, the most effective preventative programs focus on quality assurance and quality control, which includes developing protocols of well documented and appropriate levels of accuracy, precision, sensitivity, and specificity. The proper implementation of quality programs must be assessed and this is typically performed through third-party audits. The combined requirements for monitoring, oversight, and notification are needed to give the FDA, consumers, and other stakeholders confidence in the program.
If you have questions about how FSMA will impact your company, contact James Markwiese or David Thal at 865.376.7590.