A little over a month ago, on June 3, 2011, Deputy Director Donald Kraemer of the U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) issued a statement regarding the E. coli O104:H4 outbreak in Europe.

fda-logo.jpgThe statement was published on the FDA website as well as on various news websites. In addition to informing the U.S. public that FDA was collaborating with the European Union and the Centers for Disease Control and Prevention (CDC) to monitor the ongoing outbreak of E. coli O104 and to track any illnesses in the U.S. that may be related to the outbreak, the statement reassured U.S. residents that additional safety precautions were being taken to control imports of produce.

However, perhaps what was most significant about FDA’s statement was a single sentence that read: “The FDA considers any disease-causing strain of E. coli in food to be illegal.” Food safety advocate, Bill Marler, applauded this bold language in a July 4, 2011 blog post, but also questioned why the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS), the other major agency in addition to FDA responsible for food safety regulation and policy making, seems to take a different stance.

Marler explained that, in contrast to FDA’s statement, FSIS deems only one pathogen – E. coli O157:H7 – as an adulterant and not other non-O157 shiga toxin-producing E. coli (STECs). So why the discrepancy between these two agencies charged with keeping our food safe?

Well, interestingly enough, it seems that the discrepancy no longer exists. On July 5, 2011, the sentence providing that “FDA considers any disease-causing strain of E. coli in food to be illegal,” was deleted from the published statement. The altered statement can now be viewed on FDA’s website here. FDA made no mention of the July 5 revision to its statement. Essentially, FDA has made a quiet retraction of what could have been a firm position on non-O157 STECs.

So where does all of this leave us? Dr. Richard Raymond provides some insights in a blog post published earlier today and republished, in part, below:

FSIS submitted to the Office of Management & Budget (OMB) what most think was a proposal for rule making to establish six non-O157 STECs to be considered adulterants in ground beef. OMB has sat on the proposal for nearly six months now, and many believe that is due to pressure from USTR and industry to not allow the rule to be promulgated.

If that is the case, and if the 2012 elections entered into the decision to not move the rule making forward, then the Administration cannot have FDA saying it “considers any disease-causing strain of E. coli in food to be illegal.”

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Politicos and food safety advocates that push for a single food safety agency like to say we have 15 departments and/or agencies involved in food safety.

That might be true, but the two that provide 99% of the regulation and policy making are USDA/FSIS and FDA. For those two to have opposed views and policies on something as controversial as non-O157 STECs just “wouldn’t be prudent,” to use a former President’s oft-cited quote.

The OMB (the President) had two choices:

  1. Move the FSIS proposal to declare non-O157 STECs to be adulterants and get them out of commerce, or
  2. Remove the singular sentence from the June 3, 2011, press announcement. 

There may be other choices being made that are equally as non-transparent as the decision to strike the sentence. Moves like finding a new Director of Communications for FDA, or maybe a new Deputy Director of CFSAN. Time will tell.

But I do think we now know for certain the choice the Administration has made, for the time being at least, about letting FSIS move forward with rule making.