This is the first article in a three-part series that examines developments in and the future of the FDA Food Safety Modernization Act.
By Will Woodlee, Esq.
Spring has sprung, and the U.S. Food and Drug Administration (FDA) once again finds itself investigating a multi-state outbreak of produce-related Salmonella infections. As of this writing, the ill total 81, 16 of whom have required hospitalization. Fortunately, FDA has not attributed any deaths to these Salmonella infections.
The outbreak has stretched across 18 states, from California to Massachusetts, and officials have traced the infections to cucumbers imported from Mexico and distributed by an Arizona firm. FDA has since placed products from the two Mexican producers on an Import Alert. This action effectively halted importation of the operations’ produce absent evidence that each shipment is not contaminated.
The cucumber case provides a particularly apt example of the potential consequences of FDA’s long-delayed implementation of several key provisions of the FDA Food Safety Modernization Act (“FSMA"). Heralded as the first major overhaul of the U.S. food safety laws in more than 70 years, FSMA has not yet had a fair opportunity to deliver on its lofty aims. Twenty-nine months into the implementation process, the agency still has much work to do in changing the U.S. food safety system from one of reaction to one of prevention. FDA has failed to meet a number of its statutory deadlines for publishing the most critical FSMA regulations due to resource limitations, the complexity of its rulemaking assignments, and perhaps other factors. The missing rules would establish:
· Science-based minimum standards for conducting hazard analyses and implementing preventive controls at food facilities (deadline for final rule: July 4, 2012);
· Science-based minimum standards for the safe production and harvesting of certain fruits and vegetables (deadline for proposed rule: January 4, 2012; deadline for final rule: one year after close of comment period for proposed rule); and
· Requirements for risk-based foreign supplier verification programs to be used by food importers (deadline for final rule: July 4, 2012).
All three sets of regulations are critical to realizing FSMA’s paradigm shift. The law technically required that food facilities and importers implement preventive controls and foreign supplier verification programs by July 4, 2012, and January 4, 2013, respectively. However, in a trio of June 2012 letters to industry groups, FDA revealed the agency would not enforce these requirements without having implementing regulations in place. In addition, FSMA does not require compliance with any produce-safety standards until FDA establishes the particular requirements by regulation. In that it involved contaminated fresh produce imported from a foreign country, the recent cucumber outbreak underscored the need for final regulations for importers and growers.
Milestones Reached for Two Major Rulemakings
In recent months, FDA has made progress on two major FSMA rulemakings. After exceedingly long review periods at the White House’s Office of Management and Budget (“OMB"), two lengthy proposals were released in January 2013—one on hazard analysis and preventive controls requirements for human food facilities and one on produce-safety standards. The first proposes that covered firms have written food-safety plans that identify potential unintentionally introduced hazards, take steps to address them, verify the steps’ effectiveness, and outline the process for correcting any problems that may arise. The proposal also focuses on delineating the scope of the requirements and of the various facility and activity exemptions (e.g., for facilities solely engaged in the storage of certain packaged foods).
In the second proposal, FDA proposes produce-safety standards intended to address a number of areas of risk, including:
· Agricultural water;
· Biological soil amendments;
· Health and hygiene;
· Domesticated and wild animals; and
· Equipment, tools, and buildings.
The produce proposal likewise focuses on issues of scope, including what types of products are covered—most fruits and vegetables while they are in their raw or natural (unprocessed) state—and what products are not (e.g., raw agricultural commodities that are rarely consumed raw, such as beets, figs and potatoes).
The proposal also includes a unique set of standards applicable to sprouts, which “present a special concern with respect to human pathogens . . . because of the warm, moist, and nutrient-rich conditions required to produce [them], the same conditions that are also ideal for the proliferation of pathogens if present." Between 1996 and 2010, 34 outbreaks were associated with contaminated sprouts, the most of any produce type.
The publication of each proposal opened an initial 120-day comment period during which stakeholders could review and submit written responses to the draft regulations. Following calls to extend the periods, FDA recently announced stakeholders will have until September 16, 2013, to submit written or electronic comments on all aspects of both proposals. The agency apparently agreed with the requestors that, without the extensions, interested parties might not have “sufficient time to develop a meaningful or thoughtful response to" each proposal. This development may result in FDA issuing final regulations later than it otherwise would have, though the agency asserted it could provide the public an additional 120 days to comment “without significantly delaying rulemaking on these important issues."
These proposals represent significant progress toward implementing produce-safety standards and requirements for hazard analyses and preventive controls. However, FDA has much work to do to finalize the regulations. Further, with proposed staggered compliance dates beginning a year after publication of the hazard analysis and preventive controls final rule, it could be years before FDA begins enforcing these regulations.