The size and severity of Europe’s E. coli O104:H4 outbreak was coming into worldwide focus as May passed into June, and it was time for the American government to say something.
That task fell upon the U.S. Food and Drug Administration (FDA), which issued a statement from Dara Corrigan, associate commissioner for regulatory affairs, and Donald Kraemer, deputy director for FDA’s Center for Food Safety and Applied Nutrition.
Because the deadly Euro outbreak was caused by a strain of E. coli previously unknown outside a few advanced laboratories, one line in the statement released on June 3 was especially reassuring to Americans. It said:
“The FDA considers any disease-causing strain of E. coli in food to be illegal.”
That single line, part of a longer comment by Kraemer, has since been scrubbed from the Press Announcements section of FDA’s website.
Asked why by Food Safety News, Kraemer declined to answer, directing us “to come into the agency through our press office.”
The same inquiry made to FDA’s press office also went unanswered.
FDA twice updated the June 3 news release, once on June 6 and again on June 17.
It is not known when the line was removed, but the original FDA press release was replicated on numerous sites around the Internet. U.S. interest in the Euro outbreak was just peaking at the time. What the Americans were saying about food safety had worldwide interest.
More than a month after the FDA’s announcement, on July 4, food safety attorney Bill Marler picked up the original news release from one of the sites that had carried the entire statement.
Marler, who is also publisher of Food Safety News, was musing on his personal blog about the differences between FDA and USDA when it comes to E. coli strains that have caused disease in humans. The USDA considers only O157:H7 to be an adulterant and bans it from ground beef.
A day later, Marler learned that the strong statement — “The FDA considers any disease-causing strain of E. coli to be illegal” — was gone, removed from the official agency website.
What’s not known is when it was removed, who ordered the change, and why?
When Carol Tucker-Forman, director of the Consumer Federation of America’s Food Policy Institute, first heard that the statement on disease-causing E. coli had been removed from FDA’s website, her first thought was that the agency’s computer system must have been hacked.
Forman said that if a computer hacker was not to blame, the Obama Administration must have decided the statement was not in line with policy, putting some considerations other than food safety into play when it comes to dealing with potentially deadly pathogens in the food supply.
All this comes as E. coli policy-making is under way in Washington, D.C. USDA’s Food Safety and Inspection Service (FSIS) has sent proposed policies to the Executive Office of Management and Budget (OMB) that would declare six virulent, non-O157 Shiga-toxin producing E. coli (STEC) as adulterants in ground beef.
That’s the outside step in a policy process that could end with FSIS requiring testing for the “Big Six” non-O157 STECs. The OMB has not approved the proposal, which is opposed by the American Meat Institute as well as some of the country’s trade partners. The U.S. Trade Representative has gotten involved in the issue, even sitting in on OMB meetings.
With all that going on, it seems unlikely FDA’s website was edited without outside pressure from USDA, OMB, the USTR or all of the above.
“It does not look good for the President if his two agencies with most of the authority for food safety cannot be on the same page,” says Dr. Richard Raymond, former USDA under secretary for food safety. “And it looks especially bad for the President if his OMB and USTR are sitting on the rule for political reasons, while Don and the FDA are acting like Lone Rangers, and speaking off the ranch.”
Although the bold statement is gone, the E. coli policy is probably unchanged for the 80 percent of the food supply that is regulated by FDA. David Acheson, the agency’s former Commissioner of Foods, says if FDA finds E. coli O104:H4 or any other disease-causing strain contaminating food in or entering the U.S., it will take action to protect the public health.
He says he cannot imagine the agency doing otherwise.
To compare the FDA’s June 3 press release with its current statement:
Original version (emphasis added):
“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.”
“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 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.”