I was rereading the June 3, 2011 (the original version) Food and Drug Administration (FDA) statement on the E. coli O104:H4 outbreak in Europe on my flight to Seattle from Boston this week after meeting with a man who had spent over 30 days hospitalized with hemolytic uremic syndrome from eating non-O157 E. coli – tainted fenugreek sprouts.


On June 3 the FDA assured the U.S. public that we “receive relatively little fresh produce from the EU, particularly at this time of year.” But, “in response to the outbreak in Europe, as a safety precaution, FDA established certain additional import controls within 24 hours of the health advisory issuing in Germany. FDA is currently conducting increased surveillance of fresh tomatoes, cucumbers, lettuce and raw salads from Germany and Spain.”


That was before the Egyptian fenugreek seed sprouts were linked to the illnesses and deaths.

Here was FDA’s position in the statement on pathogens in our food:

“Food growers, manufacturers and distributors are responsible for marketing safe food and taking any steps necessary to ensure that their products are indeed safe,” said Donald Kraemer, deputy director of the FDA’s Center for Food Safety and Applied Nutrition. “The FDA considers any disease-causing strain of E. coli in food to be illegal. The FDA has provided scientific guidance to the produce industry on ways to minimize the risk of E. coli, and these methods will reduce the risk of the strain of E. coli causing the European outbreak as well as the more common strains.”

For a day this week there was some confusion regarding FDA’s June 3rd statement and FDA’s policy on non-O157 E. coli after the emphasized language above was removed from the statement.  I pointed out the mysterious disappearance of the sentence in my post – “The FDA and Revisionist History of its Position on non-O157 E. coli,” and promptly received a response from the FDA that, despite the sentence’s removal, FDA’s policy remains – “FDA does consider any disease-causing strain of E. coli in food to be illegal.”


I felt better.

I assume that the FDA continues to take this position from 21 USC §342:

A food shall be deemed to be adulterated:

(a) Poisonous, insanitary, or deleterious ingredients.

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health;

The FDA’s Center for Food Safety & Applied Nutrition (CFSAN) takes its mission statement to heart as it “is responsible for promoting and protecting the public’s health by ensuring that the nation’s food supply is safe, sanitary, wholesome, and honestly labeled, … properly labeled.”

Interestingly, the U.S. Department of Agriculture’s Food Safety Inspection Services (FSIS) has a remarkably similar charge in 21 USC §601:

(m) The term ”adulterated” shall apply to any carcass, part thereof, meat or meat food product under one or more of the following circumstances:

(1) if it bears or contains any poisonous or deleterious substance which may render it injurious to health

Yet, FSIS deems only one pathogen – E. coli O157:H7 – as an adulterant. Seriously, this means that if E. coli O104:H4 was found on meat in a plant or in the hamburger you bought at the store for the Fourth of July barbecue, the FSIS’s position is that it is perfectly fine – until people start getting sick.


The FDA takes the position that it “considers any disease-causing strain of E. coli in food to be illegal.”

FSIS does not. Why?


Given FSIS’s Mission Statement it make little sense:

The Food Safety and Inspection Service (FSIS) is the public health agency in the U.S. Department of Agriculture responsible for ensuring that the nation’s commercial supply of meat, poultry, and egg products is safe, wholesome, and correctly labeled and packaged.

When that next cargo of beef, hogs, lamb comes in from overseas with a non-O157 E. coli tagging along for the trip, what will be FSIS’s and the meat industry’s explanation?  “Shit happens?”

Here is a bit(e) of history on the topic by Michele Simon at Food Safety News“A Decade of Inaction at USDA on Non-O157 E. coli.”

To read more on non-O157 E. coli and FSIS’s position on it, see this post – “Petition Number 09-03: Petition for an Interpretive Rule Declaring all enterohemorrhagic Shiga Toxin-producing Serotypes of Escherichia coli (E. coli), including Non-O157 Serotypes, to be Adulterants Within the Meaning of 21 U.S.C. § 601(m)(1)” and follow all the links.

I would love to hear someone at FSIS, FDA, USDA, HHS or the White House explain the non-O157 E. coli conflict between FDA and FSIS.  Any takers?