FDA Issues FSMA Preventive Controls Guidance for Small Businesses

  • By: Staff Editor
  • Date: November 11, 2016
  • Source:
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The U.S. FDA has recently released two Food Safety Modernization Act (FSMA) compliance guidance documents to aid small businesses with the implementation of the Preventive Controls for Human Food and Preventive Controls for Animal Food rules.

The guidance summaries who need to comply with the rule, who is exempt from parts of the rules, and outlines key information for qualified facilities.

Key Requirements

According to the guidance, all covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. The rule sets requirements for a written food safety plan that includes:

  • A hazard analysis
  • Preventive controls
  • A risk-based supply chain program, if appropriate
  • A recall plan, if there is a hazard requiring a preventive control identified for an animal food
  • Monitoring procedures
  • Corrective action procedures
  • Verification procedures

Compliance Dates

  • Small businesses, mostly those with fewer than 500 full-time employees, need to comply with the human and animal food rules by September 18, 2017.
  • Very small businesses, generally those typically averaging less than $1 million per year in human food sales or $2.5 million per year in animal food sales, are required to maintain records supporting Qualified Facility status as of January 1, 2016.
  • Qualified facilities should comply with the human and animal food rules by September 17, 2018.

Related Training:

FSMA Gives FDA Fee Collection Authority for Certain Violations

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