The Food Safety Modernization Act (FSMA) was enacted in January 2011 to increase the safety requirements for food facilities, as well as the FDA’s role in monitoring compliance with our food safety laws. Ever since this ambitious (and necessary) overhaul, the industry has watched carefully for the FDA to begin enforcing food companies’ compliance with its new responsibilities. However, the FDA recently delayed enforcement of compliance with major provisions of FSMA – mainly the hazard analysis and preventive controls requirements – until final regulations are implemented.
The FDA’s delay relates to two FSMA provisions, sections 103 and 301. Under Section 103, effective July 2012 according to the statute, food facilities are required to evaluate hazards, identify and implement preventive controls to minimize hazards in a written plan, monitor the performance of those controls and maintain records of their monitoring. Thereafter, food facilities are required to reanalyze their plan every three years or whenever there is a significant change in operations. Section 301, statutorily effective January 2013, requires the US to perform risk-based foreign supplier verification activities to verify that all imported foods comply with US law.
In May 2012, industry associations including the Grocery Manufacturers Association wrote letters to the FDA asking for clarification of its plans regarding enforcement of FSMA’s preventive controls and foreign supplier verification provisions because of the imminent effective dates for these measures. The FDA’s Deputy Commissioner for Foods Michael Taylor responded to these concerns, replying for example to the Grocery Manufacturers’ inquiry on June 18, 2012, stating that
the FDA is committed to a “full and timely implementation of FSMA.”
Taylor’s letter makes clear, however, that the FDA “will expect to enforce compliance” in time frames established in the final rules, whenever those may come.
While such final rules for the preventive controls and foreign supplier verification provisions have yet to be published, it is clear that the industry will have additional time to come into compliance with these new responsibilities.