Earlier this month, the FDA issued its plan for implementing the Food Safety Modernization Act (FSMA), which was signed into law by President Obama in January 2011.

FSMA gives the FDA a “new public health mandate” and responds to the “dramatic changes” that have occurred in the global food system over the last 25 years.  It also takes into account science’s increased understanding of foodborne illness and its consequences, including the realization that preventable foodborne illness is a significant public health problem and a threat to the economic health of the food system.

FSMA is “grounded in this understanding of how food safety can be protected in today’s global food system.”  The recently released strategy document outlines the next phase of FSMA implementation.

FDA is in the midst of drafting rules and guidance required to establish the new prevention-oriented standards for which FSMA calls.

Planning has also begun for the “next phase of FSMA implementation, which involves operationalizing the new public health prevention standards and implementing on the ground the strategic and risk-based industry oversight framework.”

The FDA’s Blog Post on the subject, We’re Reinventing Ourselves to Keep Your Food Safe, makes it clear that the implementation of FSMA is seen internally as a significant turning point.  It points out that in the past 15 months, FDA has proposed seven new rules that establish a comprehensive framework of modern, prevention-oriented standards, as mandated by FSMA.

The new approach and operational strategy for FDA’s food safety program includes the following elements:

  • Strategic and Risk-Based Industry Oversight using an expanded oversight tool kit that includes:
    • regulatory incentives for compliance (such as less frequent or less intense inspection for good performers),
    • third party audits to verify compliance,
    • commodity and sector-specific guidance,
    • education and outreach, and
    • technical assistance to facilitate compliance.
  • Advancing Public Health by reducing the risk of foodborne illness
  • Leveraging and Collaborating with partner agencies (at local, state, federal, and international levels)

The Appendix to the Operational Strategy lays out the manner in which the strategy will be implemented in regard to preventative controls in food and feed facilities, produce safety standards, and import oversight.

FDA will draw on its experience implementing Hazard Analysis Critical Control Point (HACCP) in seafood and juice processing operations, but recognizes that preventative controls in food and feed facilities will need to be much more diverse in order to be applicable to all covered facilities.

FSMA provides FDA with an inspection frequency mandate for food and feed facilities, and its public health prevention framework calls for “transformative change in how FDA uses its inspection authority.”  FDA will use a wider range of inspection, sampling, testing, and other data-collection activities.  It will also use the new enforcement tools available under FSMA, including both administrative compliance tools and judicial enforcement tools.

Administrative compliance tools include voluntary correction of problems at the facility level, voluntary correction achieved at the district level through deficiency letters, administrative detention of product, voluntary and mandatory recalls, and administrative suspension of registration.

Judicial enforcement tools include seizure and injunction actions, as well as criminal prosecution.  The latter can be taken against firms that falsify records, lie to FDA, or knowingly put consumers at risk, among other violations.

Also outlined are the guiding principles for implementation of produce safety standards.  This sector poses even greater oversight challenges, given the scale and diversity of producers.  FDA was not given an inspection frequency mandate for farms, likely given the fact that FDA does not have the resources to make routine on-farm inspections.

FDA will instead focus its produce safety standard efforts on deploying a cadre of produce safety experts in headquarters and the field, supporting public and private parties involved in audits and other accountability functions with technical assistance and other collaborative support, taking administrative compliance and enforcement action when needed to correct problems that put consumers at risk, and responding to produce outbreaks effectively to lessen impact on public health.