Two non-profit advocacy groups - the Center for Food Safety and the Center for Environmental Health – have filed a complaint for declaratory and injunctive relief against FDA. The complaint, filed in the United States District Court for the Northern District of California, seeks to compel FDA to issue Food Safety Modernization Act (FSMA) rules that have been excessively delayed, in the opinion of these advocacy groups, at OMB.

The complaint states, in somewhat dramatic language for a  court filing, that,”…FDA has missed not one, not two, but seven deadlines, and counting, in failing to implement FSMA’s major food safety regulations. FDA has submitted several of these unlawfully delayed regulations to the Office of Management and Budget, where they are still awaiting approval. However, FDA has authority to promulgate the regulations without OMB approval.”

The complaint further states that, “FDA’s failure to implement FSMA’s critical food safety regulations by their statutory deadlines is an abdication of the agency’s fundamental responsibilities. Moreover, the agency’s unlawful delay is putting millions of lives at risk from contracting foodborne illness.”

Notwithstanding the hyperbole of these assertions, the filing of this complaint is indicative of the developing level of frustration on the part of many of the stakeholders in the food safety world over these delays.

As this author pointed out in his recent lecture on Produce Food Safety at Michigan State University, we expected the Produce Safety Rule to be issued in January on the scheduled statutory due date. Nevertheless, we are still waiting.

We note that the Centers for Disease Control have recently (August 27) raised the death-count on the Fall 2011 cantaloupe listeriosis outbreak to 33.[1] Many of this author’s Florida farming clients are cantaloupe growers, and they have had the frustrating experience of working through their 2012 season (the month of May) without any guidance whatsoever from FDA in a year that followed the second highest loss-of-life in a single food safety incident in the past 50-years.[2] 

The complaint is titled: CENTER FOR FOOD SAFETY and CENTER FOR ENVIRONMENTAL HEALTH v. MARGARET M. HAMBURG and JEFFREY ZIENTS, Case No. 12-4529, filed August 29, 2012.

The complaint is posted below:


[1]Multistate Outbreak of Listeriosis Linked to Whole Cantaloupes from Jensen Farms, Colorado, August 27, 2012 (FINAL Update Addendum)

http://www.cdc.gov/listeria/outbreaks/cantaloupes-jensen-farms/082712/index.html

[2] The Mexican Cheese listeriosis incident of 1985 was the highest loss-of-life ever recorded in a US food safety incident with a total of 48 deaths.

http://www.fda.gov/Food/ScienceResearch/ResearchAreas/RiskAssessmentSafetyAssessment/ucm185206.htm