In Litigation, FDA Explains and Defends FSMA Efforts

By Ricardo Carvajal –

We previously reported on a lawsuit that seeks to compel OMB and FDA to accelerate the implementation of FSMA.  Now the government has filed a motion to dismiss the case and for summary judgment.  The motion provides a full accounting of FDA’s efforts to implement FSMA, and is worth reading for that reason alone.  However, students of administrative law will also find it worth their time.

The motion sets the stage by noting the difficulty of the challenge of implementing FSMA due to the enormity and diversity of the food supply:

The regulations FDA has been directed to promulgate are novel and complex, and that complexity is increased by the need to build a cohesive system of regulatory controls integrating different regions and countries, as well as different food types. The enormity and scope of the task given to FDA cannot be overstated: FDA regulates over $450 billion worth of domestic and imported food and hundreds of thousand registered food facilities; FDA’s responsibility in the food area generally covers almost all domestic and imported food (except meat, poultry, and frozen, dried, and liquid eggs, tolerances for pesticide residues in foods, and requirements for public (tap) drinking water); the diversity of FDA regulated food (including, for example, perishable and non-perishable, seasonal, processed and raw agricultural commodities) necessitates a regulatory system that addresses a large variety of concerns; and the complexity of the food industry and the technologies used in food production and packaging are increasing…. Through FSMA, Congress directed FDA, for the first time, to develop comprehensive, science-based preventive controls across the entirety of the food supply.

The motion then details the organizational structure created by FDA for FSMA implementation, but notes that the “aggressive timelines” in FSMA were essentially “unachievable” even with “several hundred” FDA employees working on the task.  FDA therefore split the required rulemakings into two “waves,” with priority given to the four rules that FDA believed “are foundational for other rules and offer the most public health benefits.”  The motion serves as a scorecard of sorts for the various rules:

First Wave
• Preventive Controls for Human Food – under review at OMB
• Produce Safety Standards – under review at OMB
• Foreign Supplier Verification Program – under review at OMB
• Preventive Controls for Animal Food – under review at OMB

Second Wave
• Intentional Adulteration – Advance Notice of Proposed Rulemaking under review at FDA
• Sanitary Transport – draft codified and preamble language under review at FDA
• Third Party Accreditation – under review at OMB

The motion alludes to the interdependence of some of these rules, which suggests that some of them could issue concurrently.

Finally, FDA defends its decision not to enforce certain provisions of FSMA under Heckler v. Chaney.  FDA argues that the agency’s “fundamental enforcement tools are the same provisions examined in Chaney, and plaintiffs have not identified anything in FSMA that would circumscribe the discretion inherent in those provisions.”  FDA further argues that its implementation timetable is reasonable and that judicial intervention is not warranted.