U.S. FDA releases FSMA Operational Strategy Document

May 6, 2014

The U.S. Food & Drug Administration (FDA) has released the Food Safety Modernization Act (FSMA) Operational Strategy document, outlining broadly the drivers of change in FDA’s approach to food safety and the operational strategy for implementing that change, as mandated and empowered by the FSMA.

FSMA is the most sweeping food safety legislation in the United States in more than 70 years and requires a dramatic shift in approach—to preventing foodborne illness rather than reacting to it. When FSMA was signed in to law in January 2011, the FDA initiated a plan for responding to the many mandates within the law. Up until now, the agency has focused primarily on rulemaking, the development of guidance, and developing new compliance strategies and establishing and implementing protocols to use its new administrative tools.

The next phase of FSMA implementation, in addition to continuing to develop rules and guidance documents, involves developing approaches to achieving industry compliance with the new public health prevention standards, once they are in effect, and implementing a modernized strategic and risk-based industry oversight framework. It is this new oversight framework that serves as the basis for FDA’s Operational Strategy document. The Operational Strategy will focus on how FSMA will advance public health by focusing on prevention, voluntary compliance, risk-based oversight, and expanded collaboration across the food safety community. It will be a launching pad for all food safety efforts moving forward.

The agency has to design methods to promote widespread voluntary industry compliance with the new rules, as well as establish preventive/public health-focused inspection and sampling programs to oversee compliance. In addition, the FDA is developing effective enforcement strategies to be deployed when producers, processors, distributors, and importers fail to comply on a voluntary basis.

Operational Strategy document