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FDA releases FSMA guide documents


August 25, 2016
By Doug Picklyk

As the U.S. Food and Drug Administration (FDA) moves forward with the implementation of the Food Safety Modernization Act (FSMA), the agency has issued a new draft guidance to help industry comply with certain requirements in the Preventative Controls for Human Food (PCHF) rule.

In a release sent out by the FDA, it notes that the FSMA incorporates the most sweeping reform of U.S. food safety laws in more than 70 years. The Act was signed into law by President Obama on January 4, 2011, and now the first major compliance dates will begin next month (September 19) for large food facilities.

These large human food companies will need to come into compliance with the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food rule.

The new draft guidance issued by the FDA is intended to help industry comply with certain (PCHF) requirements including:

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

The first draft guidance involves five chapters that have been made available for public comment. The eventual multi-chapter guidance will continue to be published in parts as completed. The agency plans on releasing all chapters of the draft guidance by early 2018.