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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

Marler’s Response to the American Meat Institute Statement on New Bill to Declare Additional Strains of E. coli as Adulterants

AMI: We share Sen. Gillibrand’s desire to eradicate pathogenic bacteria, but we don’t believe that an act of Congress can make these bacteria disappear. We also are puzzled by the fact that this bill is being introduced at a time when the Centers for Disease Control (CDC) is tracking an outbreak of E. coli O145 (one of the strains in the bill) associated with romaine lettuce, yet the bill would only declare the pathogen an adulterant when found on meat.

ME: Good for the Senator for doing something the FSIS and the Beef Industry should have done years ago. If a pathogen that can kill you is in your food – regardless of the type – it should be an adulterant. And, as AMI well knows, FDA has jurisdiction over lettuce and already does consider E. coli O145 an adulterant. The beef industry has been dragging its hoofs.

AMI: It is even more interesting to consider that no confirmed outbreak of any of the six strains in her bill has ever been associated with a meat product.

ME: Really? See this report put out by the CDC last week. True, there has ONLY been one outbreak linked to the consumption of beef, but there have also been outbreaks linked to animal contact. And, given the fact that few labs test for these bugs, is there any wonder that outbreaks are few and far between?

AMI: At this point, there is no test available to detect the six additional strains included in the bill.

ME: Hmm? Them why have the tests I have done on 5,000 retail samples and the 4,000 tests by USDA seem to work well? And, yes, why have the tests performed by FDA and CDC and various State labs worked?

AMI: In addition, experts at USDA have said in public meetings that the food safety systems we have in place work equally well for non-157 and O157 STECS. These systems have reduced E. coli O157:H7 on raw ground beef by 63 percent since 2000 and have helped us achieve our Health People 2010 goal for reducing these infections.

ME: The CDC estimates that non-O157 STECs cause 36,740 illnesses, 1,083 hospitalizations and 30 deaths in America each year. The CDC also estimates that E. coli O157:H7 still causes 73,480 illnesses, 2,167 hospitalizations and 61 deaths in America each year. AMI, do you really find this acceptable?

AMI: We are concerned that food safety resources in the private sector and the public sector are not infinite. It’s important to invest in technologies that will provide meaningful food safety benefits. We do not believe that declaring non-O157 STECS to be adulterants will enhance the food safety system, and we think that application of such a policy could consume resources that could be better spent elsewhere to achieve meaningful food safety progress.

ME: I like to keep things simple. If a pathogen that can kill my kid is in their food, it should be an adulterant. Here is the law:

21 U.S.C. § 601(m)(4) – SUBCHAPTER I – INSPECTION REQUIREMENTS; ADULTERATION AND MISBRANDING – CHAPTER 12 – MEAT INSPECTION – TITLE 21—FOOD AND DRUGS

(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; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health; …

(3) if it consists in whole or in part of any filthy, putrid, or decomposed substance or is for any other reason unsound, unhealthful, unwholesome, or otherwise unfit for human food;

(4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; …

Hmmm, it is hard to read the above and not think that the words apply to all E. coli (frankly, all pathogens in food). I know, I am just a lawyer, but don’t ya think that when food with animal feces (and a dash of E. coli O157:H7) in it is considered an adulterant, that other animal feces (with dashes of other pathogens) in them, should be considered adulterated too? But, hey, that is just me.

By the way, here is the Petition that I filed last October asking FSIS to deem other disease-causing E. coli’s adulterants.  No action to date.

  • Larry Andrew

    Thank you Bill…
    The arrogance of the statement by AMI deserved your pointed and accurate response.
    I just wish I could find a way to quit eating meat until you win the day. Problem is the poison is everywhere…peanuts, lettuce, sprouts, deli meats, chicken. How depressing!

  • Nicely done.

  • Lee McGuire

    Bravo! E.coli is the bug that gets most of the press but you are completely right we should expect all of our food to be pathogen infective dose free

  • I got this email this morning and I responded. Am I missing something here?
    Dear Mr. Marler,
    You stated on June 1st on your main blog the FDA already considers Escherichia coli O145 an adulterant.
    Please tell me when the FDA decided to consider Escherichia coli O145 an adulterant. I would greatly appreciate being told the location of the document that states this policy.
    The method FDA currently uses to test food samples for
    Escherichia coli O157:H7 states FDA does not have a regulatory position on non-O157 STECs. I sent you this reference several months ago. The Web address of the method and the regulatory statement is repeated below.
    I ask you this question because yesterday a formal work
    instruction (equivalent to a SOP) was made official in my laboratory. The document states my facility will not pursue screening and isolation of non-O157 STEC strains except when an outbreak of foodborne illness requires such testing.
    Use of the FDA method I mentioned in several FDA laboratories has been generating several difficulties for the detection and isolation of Escherichia coli O157:H7 and non-O157 STEC.
    I do not know what methods IEH Laboratories used for your non-O157 STEC project. I would be very interested in seeing the protocols because the organization has been successful with the methods it has been using, procedures that may be superior to the FDA BAM protocol.
    Thank you for continuing your excellent reporting. I learn more about food outbreaks from your blog than most of the communications I receive from the Agency. Keep up the great work.
    My Response:
    Good Morning – perhaps the fact that, as you say “[t]he method FDA currently uses to test food samples for Escherichia coli O157:H7 states FDA does not have a regulatory position on non-O157 STECs,� and that the FDA has never made a “this is considered and adulterant and this is not considered an adulterant,� like Mike Taylor’s pronouncement of FSIS policy in 1994, and the fact that recalls are done when FDA regulated product is contaminated with a variety of pathogens including Salmonella and non-O157’s (when found), things NOT done by FSIS except E. coli O157 and listeria in RTE foods, and recently an occasional antibiotic-resistant Salmonella case, gave me the clear impression that FDA did not make the artificial ““this is considered and adulterant and this is not considered an adulterant,� distinction. Was it wishful thinking on my part? Or, is it a proper reading of:
    Sec. 402. [21 USC §342] Adulterated Food РA food shall be deemed to be adulterated—  1(a) Poisonous, insanitary, or deleterious ingredients. (1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such substance in such food does not ordinarily render it injurious to health; [or]  2 (2)(A)  3if it bears or contains any added poisonous or added deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodity or processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 406; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 408(a); or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 409; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 512; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food; or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseased animal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionally subjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuant to section 409.
    Am I missing something? Please tell me that FDA does not actually take the position that FSIS does on pathogenic non-O157’s (or Salmonella for that matter)?
    On some of the more technical issues of testing, I will defer to Dr. Samadapour (who is presently doing testing for the FDA and industry on a variety of pathogens). Attached is his powerpoint he recently presented to FSIS.
    Thanks for the email. More “food� for thought and more “shit� to worry about.

  • Art Davis

    It seems that you are interpreting 402 and its assorted subtitles to say that EHEC bacteria are in fact already adulterants. That certainly seems a reasonable conclusion to me. Does it really require a specific regulation with a list of names to make them officially adultrants or is there something else to be gained by “Naming names”? I don’t have a problem with naming specific organisms, just wonder why it’s a good idea?