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FDA Releases Under FSMA, the Current Good Manufacturing Practice and Hazard Analysis/Risked Based Controls

Posted in Agriculture Law, Food Safety, Food Safety Modernization Act

FDA also  has released for public comment today the  proposed rule on Preventive Controls for Human Food and a proposed rule on Standards for Produce Safety. These rules are a major component of the regulations called for under FSMA.

The proposed produce rule covers all fruits and vegetables except those rarely consumed raw, produced for personal consumption, or destined for commercial processing that will reduce microorganisms of public health concern. The proposed rule is based on science and risk-analysis, and therefore focuses on areas of risk including:

  • ag  water;
  • biological soil amendments;
  • health and hygiene;
  • domesticated and wild animals; and
  • equipment, tools and buildings.

The proposed hazard analysis and risk-based preventive control requirements are similar to Hazard Analysis and Critical Control Points (HACCP) systems, which were pioneered by the food industry and are required by FDA for juice and seafood.

The proposed rule can be found at; There is a120 days review process.