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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

The FDA and Revisionist History of its Position on non-O157 E. coli

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I am old enough to remember when Politburo members would disappear from photos, and I was bothered by the Europeans when I posted – “EFSA and ECDC Change Published Risk Assessment because “some key partners involved felt that it may unnecessarily harm the company to publish its name while the investigations (into E. coli O104:H4 Outbreak) are still ongoing” – a few days ago, but, this really, in the U.S., the day after the 4th of July?

U.S. FDA CFSAN Deputy Director Donald Kraemer made a statement on June 3, 2011 regarding the E. coli O104:H4 outbreak in Europe. This statement was published on the FDA Web site and on various news Web sites. I touted it a day ago in my post – “The FDA considers any disease-causing strain of E. coli in food to be illegal. What is FSIS’s Position?”

Now the FDA Web site has a statement with different words than the original one.

The original paragraph read (my emphasis):

“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.”

The new paragraph reads:

“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.”

The bold and italic sentence – “The FDA considers any disease-causing strain of E. coli in food to be illegal” – has been removed from the FDA Web site. The FDA Web site does not mention this change nor the reason for this revision.

There are about 1,000 subscribers to my blog and over 10,000 visitors a day – many in government and the media.  Do you think someone will ask the FDA about the revision?

FYI:

Donald W. Kraemer, Deputy Director, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, College Park, MD, Phone: 301-436-2429, E-mail: donald.kraemer@fda.hhs.gov

See below for the original and revised releases:

Original FDA statement on E. coli O104 outbreak in Europe

For Immediate Release: June 3, 2011
Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov
Doug Karas, 301-796-2805, douglas.karas@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA statement on E. coli O104 outbreak in Europe
Agency is flagging imports of products of concern from two countries

The U.S. FDA has been in routine contact with the European Union and the U.S. Centers for Disease Control and Prevention to monitor the current outbreak of E. coli O104 and to track any illnesses in the U.S. that may be related to the outbreak

At this time, the Robert Koch Institute, the disease control and prevention public health agency of Germany, has not yet identified the definitive source of the infectious agent causing the outbreak, but has recommended that consumers in Germany avoid raw tomatoes, cucumbers and lettuce.

To date, FDA believes that this outbreak has not affected the U.S. food supply. The FDA is constantly vigilant and consistently takes steps to increase monitoring, as appropriate, in situations such as this, to protect the U.S. food supply.

The U.S. receives relatively little fresh produce from the EU, particularly at this time of year. Due to the short shelf life of most fresh produce and the availability of growing areas in the U.S. and Central America, the EU is not a significant source of fresh produce for this country.

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.

“When these products are presented for import, we will sample them, and we will analyze them,” said Dara Corrigan, associate commissioner for regulatory affairs, who is responsible for US FDA border activities. “The FDA will not allow any products found to be contaminated to enter the U.S., and, if contamination is found, will flag future shipments for appropriate action. As more information about the source of the outbreak emerges, we will adjust our public health protection efforts, especially those at the border, accordingly.”

“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.”

The FDA Food Safety Modernization Act, signed into law in January, gives the FDA new authority, including authorities related to the prevention of foodborne illness. The FDA is currently developing rules that will require food processing facilities to develop plans that will put in place controls to reduce the risk that food will be contaminated by disease-causing bacteria, among other things.  Additionally, the FDA is developing a science-based produce safety regulation to reduce the risk of foodborne illness from produce.  The proposed rules should be completed at the end of this year and the beginning of 2012, respectively.

Consumers can also help to protect themselves by taking some basic steps to prevent the spread of foodborne disease.

When preparing any fresh produce, begin with clean hands. Wash your hands for 20 seconds with warm water and soap before and after preparation. Wash the produce under running water just before preparing or eating. This includes produce grown conventionally or organically at home, or produce that is purchased from a grocery store or farmer’s market.

Proper storage of fresh produce can affect both quality and safety. Certain perishable fresh fruits and vegetables (like strawberries, lettuce, herbs, and mushrooms) can be best maintained by storing in a clean refrigerator at a temperature of 40° F or below. If you’re not sure whether an item should be refrigerated to maintain quality, ask your grocer. All produce that is purchased pre-cut or peeled should be refrigerated to maintain both quality and safety.

For more information:

FDA: Produce Safety

CDC Investigation Announcement: Outbreak of Shiga toxin-producing E. coli O104 (STEC O104:H4) Infections Associated with Travel to Germany  

Robert Koch Institute:  Outbreak of haemolytic uremic syndrome (HUS) caused by bacterial infection 

FoodSafety.gov on E. coli

FDA:  Food Safety Modernization Act page

Revised FDA NEWS RELEASE

UPDATE: June 17, 2011 – In response to updated epidemiological information from the Robert Koch Institute, FDA has focused its import surveillance on sprouts and seeds for sprouting from Germany. Fresh tomatoes, cucumbers, lettuce and raw salads from Germany and Spain are no longer subject to increased surveillance.

UPDATE: June 6, 2011 – FDA is currently conducting increased surveillance of fresh tomatoes, cucumbers, lettuce and raw salads, as well as sprouts and sprout seeds from areas of concern.

For Immediate Release: June 3, 2011
Media Inquiries: Siobhan DeLancey, 301-796-4668, siobhan.delancey@fda.hhs.gov
Doug Karas, 301-796-2805, douglas.karas@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

FDA statement on E. coli O104 outbreak in Europe
Agency is flagging imports of products of concern from two countries

The U.S. FDA has been in routine contact with the European Union and the U.S. Centers for Disease Control and Prevention to monitor the current outbreak of E. coli O104 and to track any illnesses in the U.S. that may be related to the outbreak

At this time, the Robert Koch Institute, the disease control and prevention public health agency of Germany, has not yet identified the definitive source of the infectious agent causing the outbreak, but has recommended that consumers in Germany avoid raw tomatoes, cucumbers and lettuce.

To date, FDA believes that this outbreak has not affected the U.S. food supply. The FDA is constantly vigilant and consistently takes steps to increase monitoring, as appropriate, in situations such as this, to protect the U.S. food supply.

The U.S. receives relatively little fresh produce from the EU, particularly at this time of year. Due to the short shelf life of most fresh produce and the availability of growing areas in the U.S. and Central America, the EU is not a significant source of fresh produce for this country.

In response to the outbreak in Europe, as a safety precaution, FDA established certain additional import controls. FDA is currently conducting increased surveillance of fresh tomatoes, cucumbers, lettuce and raw salads from areas of concern.

“When these products are presented for import, we will sample them, and we will analyze them,” said Dara Corrigan, associate commissioner for regulatory affairs, who is responsible for US FDA border activities. “The FDA will not allow any products found to be contaminated to enter the U.S., and, if contamination is found, will flag future shipments for appropriate action. As more information about the source of the outbreak emerges, we will adjust our public health protection efforts, especially those at the border, accordingly.”

“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.”

The FDA Food Safety Modernization Act, signed into law in January, gives the FDA new authority, including authorities related to the prevention of foodborne illness. The FDA is currently developing rules that will require food processing facilities to develop plans that will put in place controls to reduce the risk that food will be contaminated by disease-causing bacteria, among other things.  Additionally, the FDA is developing a science-based produce safety regulation to reduce the risk of foodborne illness from produce.  The proposed rules should be completed at the end of this year and the beginning of 2012, respectively.

This outbreak has not affected the United States. Produce remains safe and there is no reason for Americans to alter where they shop, what they buy or what they eat. In general, consumers can also help to protect themselves by taking some basic steps to prevent the spread of foodborne disease.

When preparing any fresh produce, begin with clean hands. Wash your hands for 20 seconds with warm water and soap before and after preparation. Wash the produce under running water just before preparing or eating. This includes produce grown conventionally or organically at home, or produce that is purchased from a grocery store or farmer’s market.

Proper storage of fresh produce can affect both quality and safety. Certain perishable fresh fruits and vegetables (like strawberries, lettuce, herbs, and mushrooms) can be best maintained by storing in a clean refrigerator at a temperature of 40° F or below. If you’re not sure whether an item should be refrigerated to maintain quality, ask your grocer. All produce that is purchased pre-cut or peeled should be refrigerated to maintain both quality and safety.

For more information:

FDA: Produce Safety

CDC Investigation Announcement: Outbreak of Shiga toxin-producing E. coli O104 (STEC O104:H4) Infections Associated with Travel to Germany  

Robert Koch Institute:  Outbreak of life-threatening haemolytic uremic syndrome (HUS) caused by bacterial infection 

FoodSafety.gov on E. coli

FDA:  Food Safety Modernization Act page

  • Bix

    How about that. I can’t imagine that now means the FDA doesn’t consider any disease-causing strain of E. coli in food to be illegal (unless policy really is that easy to change).

  • Minkpuppy

    When is the FDA going to claim it was hacked like Fox News and Anthony Weiner? That seems to be the excuse du jour when folx screw up lately. :-)

  • Another good story Bill. This is expecially frustrating because the FDA/USDA have been talking about the non-157 e.coli for years. We really need the White House to push harder.
    Elizabeth
    http://theagrevolution.com/2011/06/e-coli-outbreak-in-europe-may-tighten-rules-on-food-traceability-in-the-u-s/#comment-27

  • doc raymond

    Elizabeth, it is my bet that the White House is why nothing has happened. They not only are not pushing, they are sitting on USDA’s proposed rule that would make non-O157 STECs adulterants. USDA was done talking and was trying to move six months ago when they sent the proposed rule to OMB. OMB will not let them move forward, probably because of industry and the USTR concerns about New Zealand. The reason FDA has removed this line is because the Administration would then have the two largest overseers of food agency haveing two very different policies. That just cannot happen. BTW, these are just my thoughts, and thoughts only. No facts.

  • Brittany

    Perhaps the statement was removed because it was a poor one. “…any disease-causing strain of E. coli…” means just about nothing. Define disease-causing strain. Is it one that has caused disease previously in humans? We would have passed on O104:H4 in that case. Is it one that contains the genes related to disease-causing ability, enterocyte attaching and effacing gene, stx genes, things like that? We’ve found strains that contain those genes but don’t cause disease, so you can’t really make that argument, and the German strain is missing eae entirely. Perhaps it should be based on its ability to produce Shiga toxin? Also a poor indicator, as there are plenty of strains (non-STEC) which can cause disease, but lack Shiga-toxin production. A statement like that is a liability nightmare, as it implies the illegality of a characteristic that is largely indefinite at this time.
    If nothing else, the German outbreak has revealed how little we understand the factors that play a role in E. coli virulence and ecology. The German strain is an enteroaggregative E. coli that managed to pick up the stx genes. EAgg E. coli is usually found in humans, not animals, and is thought to be the main cause of traveler’s diarrhea. What worries me more than anything is that there are people out there colonized with this strain, carrying and shedding it.

  • Perhaps, it just would be nice to say that instead of just deleting it.

  • My guess is that the statement wasn’t entirely correct and they removed it after someone brought that to their attention. With microorganisms, it’s not if there are any in food, it’s how many. Products aren’t pulled because they are found to contain bacteria, they are pulled because they are found to contain a certain amount of bacteria. That’s a big difference. I’m not sure what they specific rule is regarding generic E. coli and 0157 H:7, so I can’t be sure.

  • Walt

    I sent the following message to siobhan.delancey@fda.hhs.gov :
    As a former FDA scientist and FSIS public health official, I applauded Don Kramer’s statement: “The FDA considers any disease-causing strain of E. coli in food to be illegal.”
    However, to my considerable chagrin, this sentence has subsequently been removed from his remarks. I cannot help but believe that this is another example of politics over public health.
    Therefore, I would like to register my increasing concern that the major mission of FDA, to protect public health, has become increasingly subverted in order to serve business interests. Sadly, this is a blow to the integrity of the Agency and makes it easier to believe that powers working behind the scenes are gaining the upper hand. It makes a mockery of any claims that FDA makes to be a “science-based regulatory agency.”

  • Sam

    Sam Vance – Actually that’s not true. FDA has a zero-tolerance for adulterants like O157:H7 and Salmonella meaning there is no amount of those bacteria in a food that is acceptable. Whether you find 100 per gram or 1 per 1000 grams, the the food is not acceptable for consumption. You can argue the practicality of such a rule, but considering the high virulence of some Salmonellla strains, E. Coli O157:H7 and O104:H4, it’s also hard argue how there could ever be an acceptable level.