Will The FDA Be Held In Contempt Of Court?

By Sam Lewis

Federal judge assigns deadlines to FDA regarding Food Safety Modernization Act

In January, 2011 president Obama signed into law the Food Safety Modernization Act (FSMA). This piece of legislation gave the FDA new power, including authority in preventative controls throughout the supply chain, along with enhanced authority in regard to inspections, compliance, and product recalls. In June, 2013 a federal judge in California issued a November 30 deadline for the FDA to finalize and implement the overdue rules of the FSMA.

The ruling and subsequent deadline comes in response to a court case involving the FDA. In August, 2012 two consumer groups — the Center for Food Safety (CFS) and the Center for Environmental Health (CEH) — sued the FDA in hopes of swaying the agency into publishing new rules. The court ruled that the FDA work with CFS and CEH to reach a mutually agreeable proposal.

Of course, this type of collaboration never works out, and both parties gave separate proposals to the court. CEH and CFS demanded May 1, 2014 be the deadline for all new regulations to be final. The FDA proposed no deadlines, but rather “target timeframes” to implement new rules. The FDA gave a time range of late-2014 to mid-2016 for final regulations of the FSMA to be set. The court found the FDA’s proposal to be insufficient, as it asked for deadlines, not guidelines. Instead, the court decided to balance the needs of both parties, splitting their proposed times roughly in half for the finalization of new rules.

Now, the FDA must publish all new regulations by November 30, 2013. Further, for each new regulation, the public comment period must conclude by March 31, 2014, and the FDA must finalize and publish all new rules of the FSMA by June 20, 2015. All of these deadlines apply to the following provisions: the foreign supplier verification program, preventative controls for animal feed, protection against intentional adulteration, sanitary transportation of food, and the accreditation of third-party auditors.

Conforming to the deadlines is going to be challenging for the FDA due to the sheer complexity of the rules. Additionally, the FDA will also need to allot time for the public to respond to the rules. Also, the requirement of the Office of Management and Budget to review drafts of each new law will require incredible amounts of time. Finally, the FDA must also publish the current proposed FSMA regulations on preventative controls and produce safety. With limited resources to digest the matters at hand, the FDA may have bitten off more than it can chew.