FSMA moves forward
The Food and Drug Administration (FDA) is in the midst of the rulemaking and guidance development process required to establish the new prevention-oriented standards, and Food Safety Modernization Act (FSMA) implementation teams have developed many ideas for how FDA can better oversee the food industry, strengthen the global food safety system, and enhance protection of public health.
Planning has also begun for the next phase of FSMA implementation, which involves operationalizing the new public health prevention standards and implementing on the ground the strategic and risk-based industry oversight framework that is at the heart of FSMA.
In late April, the FDA held its FSMA public meeting on implementation strategy. This was a two-day meeting with an overview from FDA on the overarching FDA implementation philosophy and strategy followed by a series of breakout sessions and a general summary session.
In May 2014, FDA released its “Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)” to guide FDA’s FSMA implementation. This March, FDA established a public docket for this strategy. The implementation strategy served as the underlying guide for this FDA meeting.
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Background of the Program
The FDA Food Safety Modernization Act (FSMA) gives FDA a new public health mandate. It directs FDA to establish standards for adoption of modern food safety prevention practices by those who grow, process, transport, and store food. It also gives FDA new mandates, authorities and oversight tools aimed at providing solid assurances that those practices are being carried out by the food industry on a consistent, on-going basis.
The central external force driving change is the dramatic expansion in the global scale and complexity of the food system. Hundreds of thousands of growers and processors worldwide are producing food for the U.S. market, using increasingly diverse and complicated processes, managing complex and extended supply chains, and making millions of decisions every day that affect food safety.
The burgeoning scale and complexity of the food system make it impossible for FDA on its own to provide the elevated assurances of food safety envisioned by FSMA and needed to maintain a high level of consumer confidence in the safety of the food supply.
Accompanying this change is the now widely shared understanding that the foundation for reducing the risk of preventable foodborne illness in today’s global food system—and providing consumers the assurances of food safety they seek—is action by the food industry.
Specifically, food safety depends primarily on the food industry, with top-level management commitment and working in a continuous improvement mode, to implement science- and risk-based preventive measures at all appropriate points across the farm-to-table spectrum, and manage their operations and supply chains in a manner that provides documented assurances that appropriate preventive measures are being implemented as a matter of routine practice every day.