- "Prevent D": New FDA Proposed Rule Seeks to Implement Preventive Food Safety System
- January 30, 2013 | Authors: Robert "Rob" E. Browne; Matthew M. Morrissey; William P. Pipal
- Law Firm: Troutman Sanders LLP - Chicago Office
On January 16, 2013, the U.S. Food and Drug Administration (the “FDA”) published in the Federal Register a proposed rule designed to put into practice the goals set forth in the Food Safety Modernization Act (the “FSMA”) which was signed into law by President Obama on January 4, 2011. The proposed rule, entitled “Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food” (the “Preventive Rule”), would have far-reaching application across the entire food industry as it would apply to any domestic and foreign firms that “manufacture, process, pack or hold human food.” The public has until May 16, 2013 to comment on the Preventive Rule.
The Preventive Rule has two major features: (1) New provisions that require hazard analysis and risk-based preventive controls; and (2) a revision of the existing Current Good Manufacturing Practice (CGMP) requirements for food, found in 21 C.F.R. part 110 (2012).
With respect to the hazard analysis and risk-based preventive controls, firms must prepare, implement and maintain written food safety plans that (1) identify potential food safety hazards that could affect food firms manufacturing, processing, packing or holding; (2) specify the steps that will be put in place to prevent or minimize those hazards; (3) identify monitoring procedures and record monitoring results; and (4) specify what actions will be taken to correct problems that arise. This food safety system must be prepared and administered by a qualified individual. The FDA describes a qualified individual as someone who successfully completes training in accordance with a standardized curriculum or is otherwise qualified throughout job experience to develop and apply a food safety system.
The Preventive Rule would also update, revise and clarify the existing CGMP for food which were last revised in 1986. Most notably, the Preventive Rule would mandate that certain existing CGMP provisions requiring protection against contamination also require protection against cross-contact of food with respect to known food allergens.
While the Preventive Rule would be broad in application, it is not without reduced requirements and exemptions for certain facilities. For instance, certain “qualified facilities” that (1) are very small businesses or (2) had average food sales of less than $500,000 per year during the preceding three-year period and that make the majority of their sales to either consumers, or restaurants or retail food establishments located within the same state or within 275 miles of the facility and purchasing the food for sale directly to consumers would have reduced requirements. Similarly, facilities that store only packaged food that is not exposed to the environment; facilities that manufacture, process, pack or hold dietary supplements or alcoholic beverages; facilities subject to the seafood or juice hazard analysis critical control point regulations; and facilities subject to the low-acid canned food regulation would be exempt from complying with the Preventive Rule.
The first compliance date for the Preventive Rule would be one year after the final rule is published in the Federal Register. The FDA is proposing, however, that small businesses be given two years to comply with the Preventive Rule, and very small businesses three years.