The Food Safety Modernization Act (FSMA), signed into law on January 4, 2011, represents a significant regulatory shift in the protection of the U.S. food supply.  The FSMA emphasizes the prevention of food product contamination rather than merely responding to it.   Due to the attendant compliance issues that come with such a shift, food manufacturers should be aware of rules proposed and finalized under the FSMA in order to reduce the risk of product liability claims or regulatory infractions.

Over the course of 2013, the U.S. Food and Drug Administration (FDA) issued a series of proposed rules intended to implement the FSMA.  The programs, requirements, and enforcement authorities embodied in these proposed rules merit particular consideration.  Running from the most recently proposed rule (having been put forward in December 2013) to least, they are as follows:

• Focused Mitigation Strategies to Protect Food Against Intentional Adulteration (December 2013)

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food for Animals (October 2013)

• Food Supplies Verification Programs for Importers of Food for Humans and Animals (July 2013)

• Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (July 2013)

• Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food (January 2013)

• Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (January 2013)

The FDA is accepting commentary on all proposed rules for a period of 120 days from the date of public proposal (meaning those rules promulgated in January are no longer open for comment). 

We will continue to evaluate the development of these rules, their implementation, and their potential impact on food product liability.