Regulatory Changes Food Safety

FSMA Compliance – Current Good Manufacturing Practices (cGMP)

Under new FSMA requirements (Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food), the Food Safety Plan is not a stand-alone program. Indeed, Current Good Manufacturing Practices (cGMP) constitute the foundations of the food safety system. With the release of the FDA’s new food safety rule for human food, previous GMP regulations in 21 CFR Part 110 were updated to the new 21 CFR 117 Subpart B.

The revised current Good Manufacturing Practices consists of 9 sections:

  • Personnel §117.10
  • Plant and grounds §117.20
  • Sanitary operations §1117.35
  • Sanitary facilities and controls §117.37
  • Equipment and utensils §117.40
  • Processes and controls §117.80
  • Warehousing and distribution §117.93
  • Holding and distribution of human food by-products for use as animal food §117.95
  • Defect action levels §117.110

The cGMP for food processing have been modernized to take into account current food safety risks and technological advances. The revised cGMPs now include a new provision for holding and distributing human food by-products for use as animal food. Other changes relate to the frequent cleaning of non-food contact surfaces to prevent against allergen cross-contact and contamination of food-contact surfaces and food. New requirements also target employee qualification and training.

The Iowa State University Extension Outreach, Department of Food Science and Human Nutrition has published a FDA Good Manufacturing Practices Checklist for Human Food to help registered facilities comply with the revised Good Manufacturing Practices (GMP) for Human Food standards. You may use the checklist to perform a gap assessment of your current practices against the revised FDA standard.

Food Safety Checklist

Sirocco can develop and validate a Food Safety Plan that meets FSMA requirements for your organization!

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