FDA Issues Preventive Controls Final Rule for Human Foods

FDA announced the publication of its final rule on preventive controls for human food.  This is a comprehensive revision of FDA food GMP regulations that adds new requirements that food facilities conduct a hazard analysis and implement preventive controls to address known or reasonably foreseeable hazards.

Compliance with the rule for most regulated businesses is required by September 19, 2016.  The analogous compliance dates for the supply chain program (incorporating new supplier approval procedures) are March 17, 2017 (if the supplier is not subject to the preventive controls or produce safety rules) or 6 months after the supplier is required to comply with the preventive controls or produce safety rules.

Very briefly, the rule establishes requirements for:

• A written food safety plan;

• Hazard analysis;

• Preventive controls;

• Monitoring;

• Corrective actions;

• Verification;

• Supply-chain program;

• Recall plan; and

• Associated records.

This rule also triggers broad new authority for FDA to inspect food facility records.  The rule was published on September 17, 2015.  For more information please visit FDA’s website at http://www.fda.gov/Food/GuidanceRegulation/FSMA/.


For questions and compliance information, please contact Dan Dwyer or Will Woodlee:  202-223-5120ddwyer@kkblaw.com, .