FDA and OMB Sued Over Delays in FSMA Implementation

By Ricardo Carvajal –

The Center for Food Safety and the Center for Environmental Health filed suit in the Northern District of California to compel FDA and the Office of Management and Budget (“OMB”) to implement several major provisions of the Food Safety Modernization Act (“FSMA”). Those provisions require rulemaking to establish or provide for:

• Hazard analysis and risk-based preventive controls
• Clarification of activities that subject a farm to facility registration requirements
• Science-based minimum standards for the safe production and harvesting of fresh fruits and vegetables
• Protection against intentional adulteration
• Sanitary transportation of food
• Foreign supplier verification
• Standards for third-party audits

The suit contends that proposed rules to implement several of these provisions have been pending at OMB for 8-9 months – a period of review that exceeds the time allotted under Executive Order 12866 (that Order mandates review of regulations by OMB within specified timeframes, and with certain exceptions).  The suit also challenges FDA’s decision to exercise enforcement discretion for certain provisions that are self-executing (e.g., preventive controls), and characterizes that decision as “a complete failure to follow a Congressional mandate.”
 
Plaintiffs cite the numerous outbreaks that have occurred since the passage of FSMA in support of their allegation that “the agency’s unlawful delay is putting millions of lives at risk from contracting foodborne illness.”  They contend that FDA’s failure to issue the regulations and OMB’s failure to provide timely review “constitutes unlawfully withheld and unreasonably delayed agency action” within the meaning of the Administrative Procedure Act ("APA").  They also contend that FDA’s failure to enforce FSMA’s self-executing provisions constitutes an APA violation.  Plaintiffs ask the court to order FDA to issue the regulations “as soon as reasonably practicable” pursuant to a court-ordered timeline, and to order OMB to approve the regulations and “cease interfering with FDA’s promulgation” of those regulations.  Plaintiffs also ask the court to order FDA to “enforce all self-executing FSMA regulations immediately.”
 
The filing of this lawsuit comes as little surprise given the constituencies that backed passage of FSMA and the delays in the completion of OMB’s review.  APA litigation to compel agency action is typically protracted, so we expect to follow this case for months (if not years) to come.