Header graphic for print
Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

So, Why Isn’t the USDA FSIS Proud of Their Six non-O157 E. coli Tests?

Screen shot 2011-05-05 at 12.19.55 PM.pngReally?  I had to learn it from a GAO Report that “[a]s of February 2011, officials for USDA’s meat and poultry regulatory program said that the department had developed standardized tests to detect all six strains.” Perhaps Secretary Vilsack was just too shy yesterday to tell me. 

The last I heard (a few months ago) was that FSIS was waiting until it had all six tests developed in-house before they would move to deem “The Big Six” (like O26, O45, 0103, O111, O121, and O145) adulterants which those (and other non-O157’s) cause 36,000 illnesses, 1,000 hospitalizations and 30 deaths in America each year.  Perhaps Secretary Vilsack was just too shy yesterday to tell me.

So, buried on page 14 of the report is this:

Recently recognized pathogens have been associated with a variety of foods, including meat and fresh produce, that are not addressed either by the commodity program’s purchasing specifications or by federal regulations. Specifically, public health officials have shown that at least six strains of E. coli other than E. coli O157:H7 produce the same potentially deadly toxins and life-threatening illness. CDC has estimated that these strains cause approximately 113,000 illnesses and 300 hospitalizations annually in the United States. Outbreaks associated with these six strains of E. coli have involved lettuce, raw ground beef, and berries, among other foods, according to CDC. For example, in 2010, two students in New York state developed a disease with complications, such as kidney failure and anemia, after consuming romaine lettuce contaminated with one of these strains, which the school district purchased commercially. Officials in this district told us that, as a result of the outbreak, the district reduced the amount of lettuce it served and stopped purchasing the particular bagged lettuce product associated with the outbreak.

Although USDA’s commodity program has not developed any purchasing specifications related to microbial contamination to address the risks from these non-O157 strains of E. coli, federal regulatory agencies have considered taking action to address them, and some food companies have begun to test their products for these strains. In October 2007, USDA, FDA, and CDC cosponsored a public meeting to consider the public health significance of non-O157 E. coli in the U.S. food supply. As of February 2011, USDA’s meat and poultry regulatory program is considering conducting routine testing for the presence of six non-O157 strains of

E. coli in certain raw beef products. In addition, some companies in the food industry have developed their own tests and are currently using these methods to determine whether the food they produce is contaminated with strains of non-O157 E. coli. For example, we visited one produce company that routinely tests its leafy greens for these strains. In addition, USDA’s meat and poultry regulatory program has collaborated with industry to develop tests that could rapidly detect six such strains in raw ground beef. As of February 2011, officials for USDA’s meat and poultry regulatory program said that the department had developed standardized tests to detect all six strains.

So, USDA FSIS, what’s next?

  • Minkpuppy

    You know, its really bad for inspector morale when Bill Marler finds out things like this before the inspection force even hears a whisper about it. Gotta love my bosses. NOT

  • John Munsell

    I ask everyone the benefit of classifiying these non-O157’s as “adulterants”, as if the mere classification would regulate these six bugs out of business. In reality, what benefit has been derived from Michael Taylor’s classification of O157:H7 in 1994 as an “adulterant”? I suggest that what our focus is to test for all 7 STEC’s, and to take whatever steps we can to control and/or eliminate them from the food chain. Instead, FSIS has merely stated that O157:H7 is an adulterant, but continues to trace the bug back to the SOURCE, thereby insulating the agency from the delicate discomfort associated with attempting difficult enforcement actions at the largest slaughterplants. When we realize that the largest plants produce 90% of our meat, while only constituting 7% of our USDA-inspected plants, we perceive the substantial and widely dispersed risk emanating from these largest plants.
    FSIS implemented HACCP to justify the agency’s desire to deregulate the industry’s mega plants. Frankly, the solution to our ongoing outbreaks is not a mere classification decision, but an agency willingness to detect the source of contamination, and then to force the source to implement meaningful corrective actions.
    Why hasn’t FSIS declared Salmonella to be an adulterant? Yes, the infective dose of Salmonella is much larger than the infective dose for E.coli, meaning that humans can ingest much more Salmonella before becoming ill. Granted. But, CDC statistics reveal that ten times as many Americans die every year from Salmonella as compared to E.coli O157:H7. So, why is the agency ascribing so much importance to E.coli, and relatively ignoring Salmonella? Answer: Jack In The Box (JITB). If the JITB outbreak had been caused by Salmonella, FSIS would have taken an aggressive stance against Salmonella, to portay an agency which is focused on reducing outbreaks.
    Bottom line: FSIS is using the “adulterant vs contaminant” classifications as a PR ploy. I don’t care about the classifications. Rather, our focus should be on detecting all bugs, and taking all measures possible to detect the sources where the bugs are transferred to meat, and then holding those sources responsible.
    John Munsell

  • doc raymond

    John, I know you know the answers to some of your questions, but maybe some of Bill’s readers do not. FSIS tried to institute regulatory action against Salmonella, but a judge declared that Salmonella was NOT an adulterant, thus tieing the Agency’s hands.
    You imply that Taylor’s declaring O157 an adulterant by using the word “merely” and asking “what benefit”? Human illness rates from O157 dropped dramatically after Taylor’s declaration, a declaration that “merely” prevented him from ever getting to the ghe Undersecretary for Food Safety at the USDA, by the way. It was a huge and bold move.
    Why declare the Big Six adulterants if current interventions against O157 also work against the non-O157s? Because industry will respond to the economic threat by increasing efforts to get cow manure out of the ground beef that I eat. Every time a test pops positive, that product does not make it to the retailer and ground beef is just that much safer.

  • John Munsell

    Hello Doc. The “Salmonella Judge” concluded that the agency couldn’t remove inspectors from Supreme Beef based on the plant’s ongoing adverse lab test results. I agree. Supreme did not kill, but was innocently purchasing meat from its source slaughter providers that was previously contaminated with invisible Salmonella bacteria. FSIS got its wish, because Supreme Beef never reopened. However, the truly noncompliant source slaughter plant(s) continued to operate as is, with no need for corrective actions, and continue to ship Salmonella-laced trimmings into commerce. Did Public Health improve just because Supreme Beef was shuttered? If Salmonella standards are ever reintroduced, they must be primarily focused at the SOURCE, not at the DESTINATION. And if tests are done at the downstream grinder plants, tests should primarily focus on incoming materials, less on finished product. But as your Meatingplace blog discussed in August 2009, the large source slaughter plants don’t want their customers testing incoming meat, or the downstream grinders might be blacklisted. Now, if the source materials are indeed safe, why would the source slaughter plants object to their customers testing incoming raw materials?
    USDA’s OIG recently reported on the systemic shortcomings (statistical irrelevance) within the industry’s N-60 testing protocol. Because of the small incidence of E.coli, N-60 testing would successfully detect the presence of E.coli less than 50% of the time, according to OIG. It’s true that when the pathogen is detected, that the hot meat is kept out of commerce, protecting consumers. However, how about the more than 50% of times when a tested lot contains the pathogen, in spite of negative test results? And how about meat which is not tested prior to shipping? For economic reasons, we can’t test all meat. Realizing that, I suggest that public health benefits more from close agency scrutiny of production lines at source originating slaughter plants, than regulating that all non-O157 STECS are adulterants. Believe me, if FSIS would ever develop the courage to closely monitor (“police”) slaughter plants, and utilize meaningful enforcement actions when fecal-contaminated carcasses are seen, the source packers will clean up their act, regardless of what classification we assign to these lethal STEC pathogens.
    In one breath, FSIS claims a “Zero Tolerance” attitude towards E.coli O157:H7 (which is impossible to achieve in raw meat). Then, the agency allows slaughter plants to experience a 3.1% incidence of adverse lab results, and concludes that such a small % does NOT constitute a “Potential” possibility of the plant having insanitatary conditions which might constitute an Event Day. Huh? Yup, as long as FSIS blithely allows plants to ship 3.1% or more of its trimmings into commerce which harbor E.coli O157:H7, who the heck cares if the agency or a judge declares the bug to be an ‘ADULTERANT”? Until FSIS develops the courage to Force the Source to clean up its act, classifications are but mere labels.
    John Munsell

  • Minkpuppy

    John,

    Re: Supreme Beef-you’re entirely right about the judge’s decision in that case. The lab results were from the meat only and proved absolutely nothing about the sanitation of the plant.

    If there had been environmental samples testing positive that indicated Salmonella had colonized in the facility or there had been excessive repetitive sanitation SOP noncompliances, the agency could have possibly proved it’s case based on the sanitation issues. I’ve heard second and third hand information that there were sufficient sanitation problems at Supreme to pull the inspectors but the agency shot themselves in the foot by using the product lab results instead of environmental samples without sufficient documentation of the conditions to back their claims up. Don’t know how true that is and I probably need to shut my mouth now before I get myself in trouble. (I still have your number, BTW).

  • John Munsell

    Dear Minkpuppy: It’s great to hear from an experienced insider like you who knows details of past historical events. I have an uncomfortable question for you, and for all readers. When FSIS rolled out its version of HACCP, the agency promised that it’s role under HACCP (1) would be “Hands Off”, (2) that FSIS would no longer police the industry, but the industry could police itself, and (3) the agency would disband its previous command and control authority. An example of the inevitable imbroglio occured at Nebraska Beef, resolved in January 2003 via an out-of-court settlement between FSIS and Nebraska Beef. The February 20, 2003 edition of Food Chemical News included this statement about the settlement: “Steven Cohen, spokesman for FSIS, told Food Chemical News earlier this month that the main reason the agency settled with the company was to eliminate the possibility that the plant could continue to operate under allegedly unsanitary conditions during months of litigation”. End quote.
    Mr. Cohen admitted that the agency lacks authority to shut down plants for what the agency “alleges” to be recurring sanitation problems. Add to this the fact that the “Salmonella Judge” told FSIS it could NOT shut down Supreme Beef for ongoing salmonella positives in finished ground beef samples. So my question to you, Minkpuppy, is what authority does FSIS have under its watered-down version of HACCP? It must be “Hands Off”, cannot police the industry, and voluntarily jettisoned its pre-HACCP command and control authority. Am I right in thinking that the agency unwittingly and unilaterally eviscerated itself of any meaningful role in the meat industry via its HACCP protocol? I’m not being a smart aleck here, I am dead serious! After FSIS made these promises to the industry, how can the agency subsequently re-embrace a “Hands On” role, police the industry, or attempt command and control functions? How can it remove inspectors from a plant? How can FSIS document alleged noncompliances, when the agency is supposed to be “Hands Off”? FSIS-style HACCP is a Hoax, a terribly bastardized pseudo science which needs to be exposed for public scrutiny.
    The agency must either have the right to police the industry via “Hands On” protocol, or not police the industry. Can’t have it both ways. The agency’s role is lukewarm as best, and fully retired at worst. The agency can’t have the right to initiate enforcement actions only when it wants to, adroitly avoiding confrontations at the largest plants which enjoy political clout and the economic wherewithal to challenge agency actions in court. Who’s on first here? Well, today FSIS may be, and tomorrow the industry. No consistency.
    What does this have to do with the six non-O157 STEC’s? Who cares how these pathogens are classified? As long as the agency must primarily consider all the legal implications before taking actions when confronted with ongoing positives of these six pathogens at large slaughter plants, FSIS decisions will be dictated not from a public health standpoint, but from a legal standpoint. Remember what Steven Cohen said regarding the Nebraska Beef litigation. Bottom line: the agency’s current style of HACCP has emasculated the agency of any meaningful involvement in the meat industry, at least at the largest plants. While we argue about the classification of these six pathogens, the agency silently allows the source slaughter plants to ship into commerce intact cuts of meat which are surface-contaminated with E.coli 0157:H7, which is already an adulterant. The precedent has been established. In the future, slaughter plants will also be authorized to ship into commerce intact cuts of meat which are surface-contaminated with 026, 045, O103, O111, O121, & O145, even though these six bugs will all be “adulterants”. Who cares? This is the beauty of deregulated meat production.
    FSIS either needs to have policing authority, and command and control authority, or not. All seven STEC’s need to be subjected to truly meaningful FSIS oversight, or not. Can’t do it halfway. Slaughter plants need to be fully authorized to ship all seven STEC’s into commerce, both in intact and non-intact products, or not. If these 7 STEC’s are pathogens (regardless of whether they are considered “adulterants” or “contaminants”), FSIS must either forbid their shipment into commerce, or fully allow such shipment. FSIS-style HACCP has created a “limbo”, an in-between never-never land where no one knows exactly what authority, if any, FSIS has. So Minkpuppy, what solution might you suggest for this conundrum? FSIS doesn’t want to address this problem, because they created it, under a so-called “Scientific” umbrella. Consumers continue to pay for the agency’s desire to enjoy comfort, provided by FSIS-style deregulation.
    Lots of questions, and I’d like to hear what you and others perceive to be the solution.
    John Munsell

  • Jess C. Rajan, Ph.D.

    FSIS has posted the test method “Detection and Isolation of non-O157 Shiga-toxin Producing Escherichia coli Strains (STEC) from Meat Products” on the Agency website:
    http://www.fsis.usda.gov/PDF/Mlg_5B_00.pdf
    http://www.fsis.usda.gov/PDF/MLG_nonO157_Flowchart.pdf
    Science-based food safety inspections require appropriate product sampling and testing for the presence of harmful (e.g. microbiological, chemical, physical) contaminants. However, there are no consistent regulatory standards, procedures and credible Quality Assurance (QA) oversight of sampling/testing of food products for these potential contaminants.
    Supreme Beef Processors split the test samples with FSIS and conducted independent salmonella testing, and claimed a different outcome and compliance with the regulatory requirements. For split sampling [21 USC, Section 702 (b)] and independent testing of products for verification of compliance with requirements, the concerned parties would need to follow comparable, transparent procedures and have credible QA oversight. During that time, FSIS lab had a non-validated test method with a “robot” (assembled in-house) for sample handling and micro-well (EIA) plates for culturing. This “robotic” procedure for salmonella testing was discontinued due to a high level of sample cross-contamination in the micro-well plates.
    Not all relevant operational information is posted on the FSIS website, and the posted information may not have details on how the data was generated and/or calculated. It is not unusual to find significant errors and inconsistencies in the regulatory testing procedures and calculations of test data.

  • Minkpuppy

    John,

    The 9 CFR 500 Rules of Practice is what gives FSIS the authority to take regulatory control action up to and including suspensions and withdrawal of inspection. What isn’t clear in a lot of cases, is how bad something has got to be before the inspector or FLS or District Office flips into “command and control” mode. The Agency says “Let the system work” and the common response to that is “How long are we supposed to let the system work before it’s obvious that it’s not working?”. No satisfactory answer for that.

    The inspectors have been sold down the river on this (Just ask Stan Painter) because FSIS didn’t know what they were getting themselves into. They rushed to implement HACCP to show that they were doing something “scientific” to deal with E. coli O157:H7 before they really knew how it would affect things. They have now effectively given the industry the clout to say, “Hey, butt out. Our records show we’re compliant regardless of what you say.” Never mind that those records could be totally falsified. Hey, I was a QC once. I know that not all checks get done (*nudge nudge wink wink*).

    I think the large plants seem to get a pass precisely because they can afford to sue. Nebraska Beef changed the game when they sued individual inspectors and the Agency basically told everybody, “If we determine you acted outside the scope of your duties, you’re on your own. We won’t defend you.” That has the inspectors treading very carefully and documenting more information that you would think is necessary to make sure it shows the plant had every opportunity in the world to get the problems fixed and didn’t do it. The NR’s also better be “justified” (and that is open to broad interpretation depending on the supervisors involved). The truth is, command-and control really hasn’t entirely gone away, it’s just not called that anymore.

    I’ve been told by former law enforcment types that they think NR’s shouldn’t be used as legal documents in court. In their opinion, the NR is more like a witness statement which can’t really be used as evidence to convict anyone. It can be used to present a case to the DA but it has to be backed up by the physical evidence. It’s kind of hard for the average inspector to keep physical evidence. They can’t keep the fecal contaminated carcass locked up in a cage or take photos of what they see. The written NR is all they have to show the plant conditions. I don’t know that they should have cameras though, especially in these days of Photoshop. Just opens up a whole other area of accusations, if you ask me.

    On a side note, if I recall correctly, Supreme Beef also slaughtered a lot of cull cows and bulls and used the argument that they had no control over whether the animals were infected. What the judge failed to understand is this: Supreme did have complete control over the dressing of those carcasses to minimize contamination. If they then used the trim off those carcasses to produce ground beef, their argument that they couldn’t control the fact that the meat came in contaminated falls apart. Someone failed to argue that point very well.

    I think the Agency screwed up by naming O157 as an adulterant and not including all other pathogens. They either are or they aren’t. When Supreme Beef can get away with the defense that the product isn’t dangerous because the consumer will cook it later, then why is O157 so special? Proper cooking destroys it as well and why is it only a problem in ground beef? There’s been outbreaks associated with intact cuts now–why hasn’t FSIS adjusted it’s thinking?

    The bottom line: E. coli doesn’t get into ground beef unless it was on the meat in the first place which means contaminated beef was shipped in contradiction to the regulation that such product cannot enter commerce. The Agency has conveniently ignored that little fact. I’m surprised that no one has challenged them on that in court.

  • John Munsell

    Minkpuppy: Every time you share, I learn, and I appreciate your experienced take on meat inspection issues.
    Your comments reflect that Supreme Beef had a slaughter plant. My memory says that the Supreme Beef plant that was shuttered by the agency was but a grinding plant, and that Supreme Beef purchased trim from a variety of slaughter plants, one of which was owned by Supreme Beef. Is my memory correct?
    Are you familiar with the “Kansas Fecal Memo”? Is it legitimate? Directly related to your comments about inspectors had better make sure their NR’s are fully correct, or that the agency can take actions against inspectors who make false claims about plant inadequacies.
    Since you still have my contact info, I encourage you to access it, ASAP. I’ll explain later.
    John Munsell

  • Minkpuppy

    I may be mixing things up with Supreme but I do remember slaughter inspectors from there being detailed out around Texas when they shut down and I could have sworn they all said they were in Dallas. My memory is shot these days. I think they also had a slaughter plant in Ladonia, near Dallas. If that plant was suppying their grinding plant I’d still argue they had control over contamination. Basically, they’re admitting they were shipping contaminated meat otherwise. The meat had to enter commerce when it was shipped to their grinding plant. Unless they claimed that the sister plant was blaneless.
    I don’t recall the “‘Kansas Fecal Memo but I know folks who would know about it. My guess is that it was one of those unofficial official documents if it existed. I wouldn’t doubt that the order to get rid of copies went out at some point. I know that superiors are now a lot more careful about what goes in writing and that a lot of the inspectors now demand instructions in writinf if goes against the regs.

  • Mark

    “The presence of salmonellae on meat does not constitute adulteration within this definition [of ‘adulterated,’ provided in 21 U.S.C. § 601 (m)]….As it said in its letter of August 18, 1971 ‘the American consumer knows that raw meat and poultry are not sterile and, if handled improperly, perhaps could cause illness.” In other words, American housewives and cooks normally are not ignorant or stupid and their methods of preparing and cooking of food do not ordinarily result in salmonellosis.’” APHA v. Butz, 511 F.2d 331, 334 (1974).