FDA Ordered to Negotiate and Propose Deadlines

By Judith Wolferts & Camille Johnson

On January 4, 2011, the FDA Food Safety and Modernization Act (FSMA) was signed into law. FSMA resulted from negotiations in Congress over the course of several years and contains specific dates by which FDA was to promulgate regulations in seven general food safety areas. FDA was required by October 4, 2011 to promulgate regulations on: (1) activities constituting on-farm packing or holding of food not raised or consumed on such farm or another under the same ownership pursuant to the Food, Drug and Cosmetic Act; and (2) activities constituting on-farm manufacturing or processing of food not consumed on that farm or another under common ownership under that Act.

By July 4, 2012, FDA was required to promulgate regulations on: (1) science-based minimum standards for hazard analysis, documenting standards, implementing and documenting preventing controls; (2) science-based minimum standards for safe production and harvesting of fruits and vegetables; (3) protecting against intentional adulteration of food; (4) use by shippers and transporters of food of sanitary transportation processes to assure food is not adulterated; and (5) foreign supplier verification program.

FSMA’s requirements include: (1) mandatory recall of covered food items, including leafy greens; (2) registration of qualified facilities; (3) identifying potential contamination sources and preparing prevention plans; (4) producing requested documents to FDA; (5) increasing investigations; and (6) promulgating regulations to handle statutory mandates and identify risks, ensure safe practices, allocate inspection resources, and trace raw food products.

Among the preventive controls proposed would be mandatory plans to identify foreseeable hazards, control and monitoring procedures to ensure compliance, and corrective actions. Regarding standards for safe growing, harvesting, packing and holding of food items, it is proposed that regulations address such things as safety of agricultural water intended for use in the food process, control of livestock and wild animal waste, and hygienic training and practices by farm workers including personal cleanliness standards.

When FDA failed to meet FSMA’s deadlines, two non-profit groups sued FDA and the Office of Management and Budget (OMB) in federal court for declaratory and injunctive relief (Center for Food Safety v. Hamburg, Case No. C-12-4529 (N.D. Cal.) (filed Aug. 29, 2012)). They asked that FDA be found in violation of FSMA and the Administrative Procedures Act due to its failure to promulgate rules by the statutory deadlines, and that the court issue a deadline for FDA to promulgate those regulations.

On April 22, 2013, Judge Phyllis J. Hamilton signed an Order in favor of the non-profit groups’ position. The Order also found FDA was correct that the purpose of ensuring food safety “will not be served by the issuance of regulations that are insufficiently considered, based on a timetable that is unconnected to the magnitude of the task set by Congress.” The court stated that its “dictating a schedule” would “necessarily be arbitrary,” and that it hoped the “parties will themselves arrive at a mutually acceptable schedule.” The court then ordered the parties to meet, confer, and submit to the court by May 20, 2013 a joint statement setting forth proposed deadlines by which FDA would promulgate rules.

FDA had numerous justifications as well as arguments why it could not comply. It stated the regulations would be “novel and complex, and the complexity is increased by the need to build a cohesive system on regulatory controls integrating different regions and countries, as well as different food types, and also coordinate with other regulations (such as regulations relating to small businesses) and other federal and state agencies.” It stated that while working on new regulations, it also was required to continue monitoring the food industry, respond to new outbreaks of food-borne illness, develop non-FSMA-related documents and regulations, and oversee safety of imported foods entering the U.S. It pointed to implementation committees it had established, the implementation committees’ working groups that had hands-on responsibility, the limited number of persons it employs who have the needed expertise, and stated the “aggressive deadlines” in FSMA “have proven to be unachievable” despite FDA’s diligent work.

The Centers for Disease Control and Prevention estimated in 2011 that 31 of the most important known agents of food-borne disease found in food consumed in the U.S. each year cause 9.4 million illnesses, 55,961 hospitalizations, and 1351 deaths. This does not include millions of persons impacted by other, unspecified agents of food-borne disease. In 2012, several industry associations wrote the FDA about FSMA, asking about preventive controls and foreign supplier verification programs.

It remains to be seen whether the parties in the lawsuit can arrive at a mutually acceptable schedule, or what that schedule might be. Even if they do reach agreement, there is a good possibility the FDA will appeal the court’s ruling. At the very least this is a complex issue, including actually promulgating the regulations, determining whether these must be reviewed and approved by OMB before they can become final, and determining conclusively whether a court has authority to impose deadlines on FDA for promulgation of regulations. In the meantime, growers and others in the food industry wait for FDA guidance and direction.

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Categories: Editorial