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The FDA considers any disease-causing strain of E. coli in food to be illegal. What is FSIS’s Position?

I was rereading the June 3, 2011 Food and Drug Administration (FDA) statement on the E. coli O104:H4 outbreak in Europe on my flight from Seattle to Boston today thinking about my upcoming meeting with a man who has spent over 30 days hospitalized from eating E. coli – tainted fenugreek sprouts.

FDA.ashx.jpgOn 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 sprouts were linked to the illnesses and deaths.

Here was (hopefully still is) FDA’s position 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.”

I assume that they 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;

revised FSIS logo.jpgInterestingly, the United States 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, if E. coli O104:H4 was found on meat in a plant or in the hamburger you bought at the store for the 4th 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:H7 E. coli tagging along for the trip, what will be FSIS’s and the meat industries 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.”

  • John Munsell

    What is in a name? What is the difference between “illegal”, “contaminated”, and “adulterated”? FSIS classifies any substance which may render it injurious to health to be adulterants. Well, don’t salmonella, e.coli, listeria, etc etc all adversely impact our health? If so, they should all be adulterants. If FDA states that any disease-causing strain of E.coli in food to be illegal, doesn’t this mean that all non-O157:H7 STECS are illegal? And then adulterants? Or are they merely “contaminants”? Or are they blithely considered to be illegal, and who cares about whether they are contaminants or adulterants? Is this bureaucratise at its confusing worst?
    Mr. Marler, could you or someone else closely familiar with these terms and their remifications dissect this classification issue, and explain how and why these bugs should be classified?
    I’ve always been intrigued by the fact that although Salmonella kills ten times as many Americans as E.coli according to CDC, Salmonella nevertheless is considered but a “contaminant”. I’m not suggesting Salmonella be classified as an adulterant, but the interesting mixture of classifications, regardless of the number of deaths & sicknesses caused, seems to be unnecessarily confusing and double talk. FDA and FSIS should both be working from the same playbook.
    Anyone want to tackle this classification dilemma?
    John Munsell

  • http://www.marlerclark.com/wmarler.htm Bill Marler
  • Bix

    I agree with John. It’s confusing and bureaucratic. And it’s a shame that, as John says, FDA and FSIS aren’t working from the same playbook.

  • Minkpuppy

    This confusion just emphasizes the need for one centralized food safety agency. There’s too much of this type of thing going on.
    I have a dual jurisdiction plant that is now being told by FDA that they’ll probably have to write yet another HACCP plan just for their seafood-containing products because apparently the one they have in place for USDA products containing seafood isn’t good enough. Never mind that the plans will essentially be identical because seafood hazards are already addressed in the USDA plan. They want their own special little plan with “FDA SEAFOOD HACCP” written on it. It’s asinine redundancy that can be eliminated by getting rid of multiple jurisdiction plants.
    Of course, an FDA inspector hasn’t even been in here. The agency is going by what a state inspector has told them and well, the state inspection here is nothing to write home about, if you know what I mean.

  • Bill Anderson

    Maybe the problem is industrialized agriculture, and maybe the solution is a food production system that is accountable to a community rather than to a centralized bureaucratic agency.
    Just a thought.

  • Theresa Kentner

    Bill Anderson–Really? How would you define community in this instance? What would be the repercussions IF I did sell something that caused an illness? Get a rope?

  • http://www.marlerblog.com Bill Marler

    You have to love this email I just got:
    Dear Bill,
    U.S. FDA CFSAN Deputy Director Donald Kraemer made a statement on
    June 3, 2011 regarding the Escherichia coli O104:H4 outbreak in
    Europe. This statement was published on the FDA Web site and on
    various news Web sites.
    The FDA Web site now has a statement with different words than
    the original one, the statement you discussed in your blog yesterday.
    The 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 sites does not mention this change nor the
    reason for this revision.
    The primary method FDA uses to test food samples for Escherichia
    coli O157:H7 is available on the FDA Web site. This method
    discusses the policy of the FDA regarding non-O157 STECs.
    I have reprinted below the two versions of Deputy Director
    Kraemer’s statement, and the regulatory position of the FDA
    regarding non-O157 STECs mentioned in the FDA Bacteriological
    Analytical Manual.
    Deputy Director Kraemer’s contact information, available to the
    public, is presented below. I would be very interested in Food
    Safety News asking Deputy Director Kraemer what is the policy of
    the FDA regarding screening of surveillance food samples for
    non-O157 STECs.
    At this time, please do not mention my name or affiliation with
    the Agency. Thanks.
    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
    U.S. FDA – FDA statement on E. coli O104 outbreak in Europe
    http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm257814.htm
    June 3, 2011
    Updated June 6, 2011 and June 17, 2011
    “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 considers any disease-causing strain of E. coli in food
    to be illegal. What is FSIS’s Position?
    http://www.marlerblog.com/lawyer-oped/the-fda-considers-any-disease-causing-strain-of-e-coli-in-food-to-be-illegal-what-is-fsiss-position
    Marler Blog
    Posted by Bill Marler on July 04, 2011
    “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.”
    U.S. FDA – Bacteriological Analytical Manual
    Chapter 4A: Diarrheagenic Escherichia coli
    http://www.fda.gov/Food/ScienceResearch/LaboratoryMethods/BacteriologicalAnalyticalManualBAM/ucm070080.htm
    February 2011
    Updated June 29, 2011
    R. Screening method for non-O157 STEC
    Both the stx1 and stx2 genes and allelic forms of these genes are
    carried by ~ 200 STEC serotypes, but many of these have not been
    implicated in illness and may be found in the intestinal flora of
    healthy humans. Be aware that the real-time PCR assay, described
    in section O, will detect these STEC strains as well. So, a +93
    uidA (-) but stx1 and/or stx2 (+) real-time PCR result is only
    indicative that the sample possibly contains an STEC, but should
    not be interpreted that it is a pathogenic STEC.
    As a group, EHEC, are a subset of STEC and comprised of
    pathogenic strains, of which O157:H7 is the prototypic strain
    (seropathotype A) (20). There are several well known EHEC strains
    that have caused illness worldwide, ie: O26, O111, O121, O103,
    O145, O45, etc (seropathotype B). **** Except for O157:H7, the
    FDA currently has no regulatory position to address the presence
    of other STEC strains in foods ****, partly due to the
    difficulties in discerning EHEC from STEC strains that have not
    been implicated in illness and may not be pathogenic. However,
    situations may arise, such as food testing associated with an
    non-O157 EHEC illness outbreak, where the analyst may need to
    pursue the isolation of these probable STEC (+). The following
    section describes isolation and confirmation procedures for
    non-O157 STEC.

  • minkpuppy

    Bill A., I have to side with Ms. Kentner on this. How would you define a community when communities come in all sizes? I live in a large city. It would be extremely difficult to supply enough safe, local food at a reasonable price to keep the citizens from going hungry.
    Large scale Ag is not going away-its role is necessary to feed a growing population. However, the way large scale farming is conducted needs to change in practical and feasible ways. It won’t happen overnight and it should not be subject to legislation based on emotional arguments.

  • Jon Bentley

    It is easier to get money, organize testing etc. and in general get peoples attention in reaction to an outbreak like the most recent one versus “potential” food safety hazard strains that haven’t wreaked this amount of havoc. We can play the “potential” game forever. In addition to existing strains, there are going to be strains that come in to play that haven’t been seen before or are old strains “reinvented”. Just take a look into any food microbiology manual or journal. Only focusing on that one strain of E. Coli is like saying that a quarterback is the only person that affects a football game.

    Commodity specific risk has to be considered but as demand for water increases globally, I think that there is increased risk potential for fatal food safety incidence, especially in the high risk food categories like sprouts. Presumably more developed countries have better food safety governance but as cost of production increases among other factors, more product is grown in third world countries where some of these water associated strains are still major issues. Take a look at the local grocery store and tell me what percentage of produce is imported from a third world country right now at any given moment in time. It is enough to know that this is a global issue and E. Coli and the STEC’s and EHEC’s aren’t the only concerns.

    Unfortunately, in a world of budget contraints and cutbacks, it seems support comes from a form of scare tactic. The outbreak in Europe is the opportunity to better protect the american and hopefully global consumer and now is the time if any to enact change concerning FSIS and other associated governing bodies. This indirectly is a chance to potentially save some lives.

    On the flip side, the inclusion of all bacterial strains of E. Coli and other strains (salmonella, clostridium etc.) that could cause death and or illness becomes a paperwork and governmental “responsibility” nightmare. We want to assign responsibility to some governing body (as there should be someone assigned) but the food safety world has been dynamic and the financial repurcussions including vested interests of associated government and private bodies translate to me that it will continually be a more amorphous subject than desired . Not to mention these governing bodies have other pressing issues of their own before accepting more responsibility.

    How much more paperwork and work are incurred by FDA when they include non-O157 STECs E. Coli in their defiinition and is their body of the government allocated more money (and/or manpower) for this work load?

    Does the outbreak associated European countries have an independent audit based food safety testing program effectively in place? This could be useful in comparison to our US systems and may potentially play a role in understanding the effectiveness of our current food risk mitigation practices.