FSMA Preventive Controls: What the Final Rule Means for Exporters to the United States
In September 2015 the US FDA issued the final rule on preventive controls for human food. Facilities that supply the US market now need a written food safety plan built on hazard analysis and preventive controls.
Key points
- The final rule on preventive controls for human food was issued in September 2015 under the Food Safety Modernization Act.
- Covered facilities need a written food safety plan prepared by a preventive controls qualified individual.
- Preventive controls go beyond critical control points and include allergen, sanitation and supply-chain controls.
What the rule requires
The rule applies to facilities that manufacture, process, pack or hold food for consumption in the United States, including foreign facilities that export to it. Each covered facility must prepare and implement a written food safety plan.
The food safety plan
- A hazard analysis covering biological, chemical and physical hazards
- Preventive controls: process, food allergen, sanitation and supply-chain controls
- Monitoring, corrective action and verification procedures
- A recall plan
How it relates to HACCP
A site with a working HACCP system has most of the foundation in place. The main differences are that controls are not limited to critical control points, that supplier controls are formally part of the plan, and that the plan must be prepared, or its preparation overseen, by a preventive controls qualified individual. Compliance dates are staggered by business size, starting in September 2016 for larger businesses.