Monday, December 10, 2012

FDA is missing deadlines for implementation of complex food safety rules

The Food and Drug Administration (FDA) has been missing the implementation deadlines that Congress set in 2009 as part of the landmark FDA Food Safety Modernization Act (FSMA). 

Food safety advocates have sued the agency because of the delays.  In a legal motion to dismiss (.pdf) filed today, FDA argues that the courts should not hold the agency liable for this failure to implement the law:
The sole remedy available for an unreasonable agency delay claim is for the court to compel agency action, such as by issuing an order requiring the agency to act, without directing the substantive content of the decision....  Although FDA has been unable to meet the aggressive statutory timelines for the seven new rules, there is no indication that Congress believed that strict adherence to those timetables is more important than careful consideration and development of these complex regulations to create an effective and modernized food safety system, provide clear guidance to the industry, and minimize later challenges or revisions to hastily adopted regulations. Accordingly, judicial intervention is not warranted at this time.

There is a certain sad logic to this argument! The courts should mind their own business, because the only possible punishment is to order the very same achievements that FDA already is failing to achieve.

I considered disputing FDA's claim about there being "no indication" of Congressional intentions for adherence to timetables.  After all, Congress did write these timetables into law.  On the other hand, Congress has not given FDA sufficient funding to meet all of its food safety objectives in the past year, and of course the next year looks even more bleak.  Although food safety advocates are unimpressed with the agency's excuses, FDA really does seem justified in implying that Congress has sent mixed signals about prioritizing food safety implementation.

I think we'll just have to be patient ... and go easy on the peanut butter.

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