FDA Promises 'Sea Change' in Food Regulation

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Michael Causey, Editor & Publisher, eDataIntegrityReport.com

The new mantra for food manufacturers better be prevention, prevention, prevention according to current and former FDAers commenting on the January 2011 passage of the mammoth Food Safety and Modernization Act.

“This law represents a sea [of] change for food safety in America, bringing a new focus on prevention…” FDA Commissioner Margaret Hamburg says.

But former FDA Commissioner of Foods Dr. David Acheson takes it further in a new white paper from Plex Online. The new law “will result in significant changes for FDA-regulated food manufacturers and processors.” FDA’s emphasis on prevention will require registered facilities to develop and maintain a written food safety plan, for starters, Acheson stresses in a new white paper “Food Safety plans: New Requirements for Registered Facilities.

As we’ve blogged before, most registered food facilities will be required to develop a clear, detailed safety plan that documents the facility’s:

  • Prerequisite programs are in place to ensure food is produced in a safe and sanitary manner;
  • Hazard analysis that identifies all potential risks throughout processing;
  • Preventive controls that are implemented to mitigate risks;
  • Monitoring of preventive controls to ensure they are properly implemented;
  • Verification that the preventive controls have the intended reduction in risk; and
  • Re-analysis of the hazards and preventive controls when there are significant changes in the process or every three years.

Acheson, now with Leavitt Partners, notes that regulated entities must soon be “able to quickly access records and demonstrate compliance with the food safety plan requirements.” They’ll also be expected to have “implemented a robust food safety program” if they want to maintain a position as a food safety leader.

He advises regulated entities to develop well-documented safety plans with strong monitoring procedures and corrective actions, for nine key areas:

  1. Facility Information: Facilities will need to document a description of the food, the methods of distribution and storage, the intended use and intended customer for all products produced.
  2. Prerequisite Programs: These programs will require a written plan, established monitoring procedures, established corrective action procedures, and an established recordkeeping system.
  3. Hazard Analysis: Facilities will be required to conduct and document these to identify potential product-related hazards, including biological, chemical, and other hazards such as terrorism.
  4. Preventive Controls: Once identified, each hazard must be evaluated to determine the significance of the hazard if it isn’t controlled, the likely occurrence of the hazards, and if it constitutes a “critical control point” that must be addressed.
  5. Monitoring: Each critical control point must be then monitored to ensure compliance with the critical limits.
  6. Corrective Actions: Beyond on-going monitoring, facilities must establish and document procedures for taking proper and effective corrective actions when critical limits aren’t met.
  7. Verification: Facilities will then need to verify that the preventive control and critical limits result in the intended control and reduction of hazard.
  8. Record-keeping: The new legislation authorizes the FDA to request access to a regulated entities’ Food Safety Plan. Each entity must establish a record-keeping system that documents their hazard analysis, critical control points, monitoring, verification, and corrective action plans and follow-up.
  9. Re-analysis: facilities are required to conduct one of their food safety plan and hazard assessment whenever they implement significant changes or every three years.

It will take some time for the FDA to decide exactly how it will enforce the new law, and its interpretation will clearly have some impact on food manufacturers and other regulated entities. But it’s equally clear that the new law means big changes for companies that make food for a living.

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