FDA Issues FSMA Guidance on Preventive Controls for Human Food

The Food and Drug Administration today (August 23) issued a partial guidance report on a key section of the Food Safety Modernization Act (FSMA): the agency’s “current thinking” on the requirement of food manufacturers to conduct a thorough hazard analysis, from which a comprehensive Food Safety Plan then must be prepared.

Specifically, the guidance report issued today involves risk-based preventive controls for human food (PCHF). The guidance is intended to help manufacturers comply with the following specific PCHF requirements in the new food safety law:

  • A written food safety plan (FSP);
  • Hazard analysis;
  • Preventive controls;
  • Monitoring;
  • Corrective actions;
  • Verification; and
  • Associated records.

This guidance covers the first five chapters of what will be a total of 14 chapters covering all aspects of FSMA. The others will be rolled out periodically.

The FDA issues guidance reports on a regular basis to enable interested parties to comment, suggest and request changes to regulations. The agency refers to this guidance as its “current thinking” on the subject, not its final regulations. To download the initial PCHF guidance, go the FDA’s website.

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