FDA Assistance in Meeting New Food Safety Guidelines

In a practical effort to help companies meet the requirements of the recent Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration released the “Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA)” strategy guide on May 2, 2014.  The guide provides an overview of the FDA’s changing role in food and feed safety assurance under the FSMA and then suggests operational guidelines for actual food and feed facilities in how to work within the FDA guidelines and implement the act.

The FDA’s strategy guide begins by explaining how the FDA’s role will change under the new FSMA regulations. The FSMA, the document explains, will reinforce the FDA’s “primary role and responsibility for food safety,” while it “also builds on and strengthens [the] FDA’s oversight role in providing technical expertise, setting and fostering compliance with food safety standards, and responding to and learning from problems when they do occur.”  The document then goes on to explain in detail the operating procedures the FDA itself plans to take in implementing the FSMA.  The FDA has three primary goals for which it has planned procedures.  First, “Advancing Public Health,” aims to reduce the risk of foodborne illness through consistent implementation of modern food safety practices, as called for by FSMA and the FDA’s implementing rules.  Second, the FDA plans to advance “Leveraging and Collaborating” by coordinating on all levels from locally to internationally to create a safer “global food safety network.”  Third, the FDA will continue its “Strategic Risk-Based Industry Oversight” to ensure food safety standards are followed with technological advances, an expanded staff with expanded scientific and technical knowledge, and more in-depth data analysis.

Perhaps more importantly, the FDA’s strategy guide then goes on to discuss how the FDA plans to implement and ensure compliance with new FSMA regulations in actual food and feed facilities.  The FDA explains its compliance monitoring approach will encourage voluntary compliance with food safety measures by providing incentives for compliant food and feed facilities, allowing voluntary correction of issues identified at individual facilities, and allowing for voluntary recalls.  Meanwhile, the FDA will still enforcing compliance through things like inspections and screenings to verify compliance with food safety measures, forced detention of potentially problematic product, and forced recalls.  The FDA then suggests ways individual facilities can help to ensure food safety measures compliance, including deploying safety experts at the facilities, increasing education about food safety measures, taking corrective action in the face of issues or full-blown contamination outbreaks, screening and verifying the safety of imported products, and developing more technical skill in evaluating imported products.

The FSMA was signed into law in December 2010, and the corresponding FDA regulations will be issued in 2015 and 2016.  The FSMA is considered the most sweeping change in food safety oversight in 70 years, and it grants the FDA correspondingly sweeping powers to act in the face of food poisoning outbreaks.  For example, it grants the FDA the authority to force recalls and the ability to perform inspections on both foreign and domestic manufacturing facilities.  The FSMA appears to be a proactive response to increasing reports of food and feed contamination and drastically declining confidence in the United States’ food supply.

To read the full FDA strategy guide, click here.


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