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FDA releases operational strategy for implementing FSMA

The US Food and Drug Administration (FDA) has released its operational strategy for implementing the Food Safety Modernization Act (FSMA), aiming to protect public health by the strategic implementation of prevention-oriented food safety standards.

"This strategy document is intended to guide the next phase of FSMA implementation by 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 FSMA," said the FDA. "The appendix provides guiding principles for how the strategy can be implemented with respect to food and feed facilities, produce safety standards and import oversight. This document will guide the work of teams responsible for developing the specific strategies, capacity building, training and operational plans needed to implement FSMA in these areas. It also provides the basis for dialogue with FDA’s government partners and other stakeholders concerning implementation of the FSMA rules."

The strategy includes:

  • advancing public health
  • leveraging and collaborating
  • strategic and risk-based industry oversight

Fulfilling the vision of risk-based prevention to protect public health—and successfully implementing FSMA—depends on close partnership and full integration of all implementation efforts carried out across the Foods and Veterinary Medicine Program, at both the work planning and operational levels, said FDA. This integrated and collaborative approach involves CFSAN, CVM, ORA, the Office of Global Regulatory Operations and Policy, and the Office of Foods and Veterinary Medicine.

FDA plans to fulfill the vision of FSMA and strengthen food safety protection by applying the principles outlined in the strategy across the entire food safety program, while adapting them to the specific challenges posed by implementation of preventive controls, produce safety standards and FSMA’s new import system.

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