E. coli O157:H7 and Mechanically Tenderized Steaks
By now, most people have come to understand that a lot of industrially produced, mass-manufactured ground beef sold in the United States can be deadly. One need only look at the recent reminder provided by the tragic story of Stephanie Smith, and the Cargill-manufactured ground beef patty that she had the misfortune to eat. But what is most certainly not understood, is that steaks can be nearly as deadly as ground beef if mechanically tenderized, a process that can drive deadly E. coli O157:H7 bacteria inside the meat, making it much harder to eliminate by customary cooking practices. As a result, thousands upon thousands of people every day feel free to order a steak in a restaurant cooked to medium-rare even though doing so could be deadly.
The serious safety risks posed by E. coli-contaminated steaks was once again made clear by the December 24 recall of 124 tons of beef products manufactured and sold by National Steak and Poultry, a meat company based in Owasso, Oklahoma. According to the FSIS Recall Notice:
FSIS became aware of the problem during the course of an investigation of a cluster of E. coli O157:H7 illnesses. Working with the Centers for Disease Control and Prevention (CDC) and state health and agriculture departments, FSIS determined that there is an association between non-intact steaks (blade tenderized prior to further processing) and illnesses in Colorado, Iowa, Kansas, Michigan, South Dakota and Washington.
To date, however, FSIS has not announced the names of the restaurants that received the steaks subject to recall, and thus consumers so far have no way of knowing whether they may have been put at risk by their choice of eating establishment. Editor’s Note: This contributed article was submitted before yesterday’s announcement that the recalled steaks were sold to Moe’s Southwest Grill, Carino’s Italian Grill, and KRM restaurants.
What makes this recent outbreak and recall particularly noteworthy is the fact that the risks posed by mechanically tenderized steaks have long been well-known by FSIS and the meat industry. Indeed, it was nearly ten years ago that the FSIS first explicitly distinguished the safety risks posed by intact versus non-intact meat. Explaining its position, the Agency stated:
In 1994, FSIS notified the public that raw ground beef products contaminated with E. coli O157:H7 are adulterated within the meaning of the FMIA unless the ground beef is further processed to destroy this pathogen….Raw ground beef products present a significant public health risk because they are frequently consumed after preparation (e.g., cooking hamburger to a rare or medium rare state) that does not destroy E. coli O157:H7 organisms that have been introduced below the product’s surface by chopping or grinding (e.g., ground beef, veal patties, and beef pattie mix). The public health risk presented by beef products contaminated with E. coli O157:H7 is not limited, however, to raw ground beef products. Given the low infectious dose of E. coli O157:H7 associated with foodborne disease outbreaks and the very severe consequences of an E. coli O157:H7 infection, the Agency believes that the status under the FMIA of beef products contaminated with E. coli O157:H7 must depend on whether there is adequate assurance that subsequent handling of the product will result in food that is not contaminated when consumed.
In explicitly expanding its E. coli O157:H7 enforcement policy to include all non-intact beef products, the Agency relied on the deliberations of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and the work it had done for Agencies in their joint development of the 1999 Food Code. One such task was to determine the “appropriate cooking temperatures for, among other things, intact beef steaks for the control of vegetative enteric pathogens.” As stated in the Policy Statement regarding so-called “intact” meat products:
Due to a low probability of pathogenic bacteria being present in or migrating from the external surface to the interior of beef muscle, cuts of intact muscle (steaks) should be safe if external surfaces are exposed to temperatures sufficient to effect a cooked color change. In addition, the cut (exposed) surfaces must receive heat to effect a complete sear across the cut surfaces . . . . The Committee’s definition of “Intact Beef Steak” limited the applicability of this conclusion to “[a] cut of whole muscle[s] that has not been injected, mechanically tenderized, or reconstructed.”
Intact Meat Policy Statement at 2803-04.
Concerned by what it deemed an unnecessary expansion of FSIS policy on E. coli O157:H7, the meat industry soon began to press the Agency to exclude mechanically tenderized meat from the policy. The meat industry sponsored research intended to show the safety of this second category of meat products. In response to meat industry lobbying, the Agency asked NACMCF to “answer several questions with regard to E. coli O157:H7 in blade-tenderized, non-intact beef.” For its part, “NACMCF concluded that non-intact, blade tenderized beef steaks could potentially contain an infective dose of E. coli O157:H7 in their interior.” [Id.] As a result, on October 7, 2002, USDA announced in a policy statement that:
FSIS is reviewing the NACMCF report and its draft risk assessment for E. coli O157:H7 in intact and non-intact (blade tenderized) steaks and will consider NACMCF’s conclusions and the conclusions from the risk assessment with regard to the policy announced for non-intact products in the January 19, 1999 Federal Register . . . . At this time, FSIS believes that the public health hazard presented by E. coli O157:H7 and the prevalence of E. coli O157:H7 in these products continues to support application of the policy announced in the January 19, 1999, Federal Register. There is a lack of data on industry and consumer practices for cooking pinned, needled, and blade tenderized steaks (e.g., grilling, oven broiling, or frying) and a lack of data on the proportion of [meat] industry outlets and consumers that prepare these products according to each of these different methods. If FSIS obtains substantial and reliable data showing that [meat] industry and consumers customarily cook pinned, needled, and blade tenderized products in a manner that destroys E. coli O157:H7, FSIS would consider modifications to its policy . . . in these products.
[Id. at 62,334].
Two years after announcing its openness to considering a change of policy, yet another outbreak of E. coli O157:H7 infections was linked to mechanically tenderized meat–this one being the third in approximately three years. Accordingly–and, predictably, I think–the Agency was forced to take some action, because, as usual, enough people had been severely injured to make it impossible not to act. And so the Agency issued a new policy statement, and required manufacturers of the implicated products to reassess their HACCP plans. As FSIS explained:
The Food Safety and Inspection Service (FSIS) is publishing this notice to inform establishments that produce mechanically tenderized beef products that their next annual HACCP plan reassessment for these products must take into account the fact that there have been three relatively recent Escherichia coli (E. coli) O157:H7 outbreaks associated with consumption of mechanically tenderized beef. This requirement applies to HACCP plan reassessments for raw and cooked mechanically tenderized beef products, including such products that are injected with marinade (or ”enhanced” products). One outbreak that was associated with consumption of mechanically tenderized beef occurred in August 2000, one in June 2003, and one in August 2004.
The occurrence of these outbreaks represents a change that would affect the hazard analysis and could alter the HACCP plans of establishments that produce mechanically tenderized beef products. Therefore, establishments that produce such products should consider the significance of the outbreaks and ensure that their HACCP plans adequately address relevant biological hazards, particularly E. coli O157:H7.
But beyond the required reassessment of HACCP plans, FSIS took no further steps with regard to this dangerous category of beef products, including testing. Indeed, in its usual we’re-still-thinking approach to such hazards, FSIS explained the lack of testing this way:
[Although]FSIS does not test the mechanically tenderized beef for E. coli O157:H7 at this time. Such raw products are non-intact beef products, however, and thus would be adulterated if contaminated with E. coli O157:H7…[and] FSIS intends to sample non-intact beef products other than ground beef in the future.
In other words, not enough people had yet been killed or made seriously ill to motivate FSIS to do anything more than, in essence, ask the meat industry to try a little harder.
And so four more years pass, and the risks posed by mechanically tenderized beef products go largely unaddressed by FSIS, despite some relatively recent warnings by consumer advocacy organizations, like the Consumer Federation of America. It was not until July 31, 2009, that FSIS decided to expand the scope of its testing for E. coli O157:H7, announcing the expansion in FSIS Notice 51.09. Specifically, the Agency stated its intent to start testing bench trim, i.e., the trim generated post-slaughter in cutting the carcasses into primals and subprimals. This change was prompted by the Nebraska Beef and other recalls involving intact cuts from which trimmings had been generated and that ended up in ground beef, thus adulterating it. To its credit, this was the first time that the agency ever started to connect (duh!) that if trimmings tested positive, the “intact” cuts from which the trimmings came might be positive for E. coli O157:H7 too. Nonetheless, the Agency was still taking no action at all with regard to mechanically tenderized beef products.
The same cannot be said for the FDA, because in 2009 that Agency issued an extensively updated Model Food Code that for the first time specifically required that mechanically tenderized meat be cooked to the same internal temperature as ground beef. In the last fully-edited version of the Code, which had been issued in 2005, mechanically tenderized meat was not explicitly subject to the higher cooking temperature requirements, this being restricted instead to “comminuted” meat. Neither was there any definition for “mechanically tenderized.” Still, the 2005 Code is explicit in only allowing “whole muscle, intact beef steak” to be served or offered for sale in a raw or undercooked condition. Thus, even if not explicit, one would need to stretch considerably to argue that the 2005 Food Code authorized the sale of mechanically tenderized steaks that the restaurant has not first thoroughly cooked. So plainly the FDA, via the Food Code, has been active in attempting to eliminate the serious health risks posed by possible contamination of mechanically tenderized steaks.
But what if a restaurant does not know that the steaks it purchases are non-intact because of mechanical tenderization. (I think this would be unlikely, but let us assume otherwise.) Well, first, both the 2005 and 2009 Food Codes impose on the restaurant an obligation to know that its steaks are in fact intact. Specifically, both versions of the Code state:
Whole-muscle, intact beef steaks that are intended for consumption in an undercooked form without a consumer advisory…shall be [o]btained from a food processing plant that, upon request, packages and labels them, to indicate that the steaks meat the definition[.]
For this to work, however, it would require FSIS to cooperate in ordering meat processing plants to label beef products according to whether they are intact or non-intact, and this is something that the Agency does not currently do. As a result, when a customer orders that his or her steak be cooked to medium-rare, the customer does so without any knowledge or understanding of the risk such an order imposes. The customer may assume (to the extent they understand the distinction at all) that his or her steak was an intact, whole muscle cut of beef that is unlikely to harbor any bacteria within its interior. This assumption will be proven wrong, however, when the customer falls ill with a deadly E. coli O157:H7 infection, and that infection is linked to other illness caused by the consumption of mechanically tenderized steaks.
 See Michael Moss, E. coli Path Shows Flaws in Meat Inspection, New York Times, at A 1. Among the many things noted in the story was the fact that Cargill manufactured the contaminated patties with a “a mix of slaughterhouse trimmings and a mash-like product derived from scraps that were ground together at a plant in Wisconsin.” To read my article on meat-industry reaction to the Stephanie Smith story, and the serious issues of ground beef safety it raised, see https://www.foodsafetynews.com/2009/10/lies-damn-lies-and-statistics/
 The Recall Notice can be found here: http://www.fsis.usda.gov/News/Recall_067_2009_Release/index.asp
 For the record, I have long been on record that this distinction is, even if based in fact, makes no sense in terms of policy. Although the theoretical risk posed by surface-contaminated intact steaks is less than the risk posed by, for example, a contaminated ground beef patty, when focused on cooking alone as a safety measure, allowing any E. coli O157:H7-contaminated meat to be distributed in interstate commerce is indefensible. To read more about my thoughts on this topic, see http://www.foodpoisonjournal.com/2009/07/articles/food-policy-regulation/more-doubletalk-from-usda-on-e-coli-and-swift-meat-recall/ As far as I am concerned, the only defensible policy is one that the USDA at times has actually seemed to have adopted, but never enforced–that is, a true zero tolerance policy for the presence of E. coli O157:H7 in or on meat. To read more about my thoughts on this subject, see my two blog-posts here: http://www.foodpoisonjournal.com/tags/zero-tolerance/
 See 64 Fed. Reg. No. 11, 2803-05 (emphases added) (hereinafter “Intact Meat Policy Statement”). For a detailed discussion of the evolution of the Agency’s E. coli O157:H7 policy, and the meat industry’s attempt through litigation to use the intact meat policy statement as a means of immunizing meat companies from product liability lawsuits, see my law review article, Preempting Food Safety: An Examination of USDA Rulemaking and Its E. coli 0157:H7 Policy in Light of Estate of Kriefall ex. rel. Kreifall v. Excell Corpor
ation, JOURNAL OF FOOD LAW & POLICY 1 J. FOOD L. & POL’Y 375 (2005) available online at www.nationalaglawcenter.org/assets/bibarticles/stearns_preempting.pdf
 See also 1999 Model Food Code, 3-201.11(E), at http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/FoodCode1999/default.htm (defining “whole-muscle intact beef steaks” as those “that are intended for consumption in an undercooked form without a consumer advisory”).
 Wendy Warren, Characterization of E. coli O157:H7 on Subprimal Beef Cuts Prior to Mechanical Tenderization: Project Summary (Aug. 2002), at http://www.beef.org/uDocs/E.%20coli%20Mech%20Tenderization_Warren_6_6_03.pdf (stating on title page “Funded by America’s Beef Producers”).
 E. coli O157:H7 Contamination of Beef Products, 67 Fed. Reg. 62,325, 62,333 (Oct. 7, 2002).
 Ellen Swanson Laine et al., Outbreak of Escherichia coli O157:H7 Infections Associated with Nonintact Blade-Tenderized Frozen Steaks Sold by Door-to-Door Vendors, 68 J. Food Protection (No. 6) 1198, 1200, 1202 (2005) (describing an outbreak in which one 52 year-old HUS victim was hospitalized for 25 days and suffered permanent brain injury, and concluding that the “USDA should consider reevaluating the microbiologic hazards of technologies used in the production of nonintact steaks”).
 HACCP Plan Reassessment for Mechanically Tenderized Beef Products, 70 Fed. Reg. No. 101, at 30331 (May26, 2005), at http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/04-042N.pdf The policy statement was followed days later by FSIS Notice 32-05, informing inspection personnel that each establishment’s annual HACCP plan reassessment must now include a look at the risks posed by E. coli O157:H7 contamination of mechanically tenderized beef products. See Notice here: http://www.aamp.com/news/documents/FSISNotice32-05.pdf
 See FSIS Q&A at http://origin-www.fsis.usda.gov/HELP/FAQs_TSC_Notice32_05/index.asp
 My law partner, Bill Marler, colorfully details all such warnings in his blog-post, which can be found here: http://www.marlerblog.com/2009/12/articles/case-news/usda-had-been-warned-of-e-coli-risk-of-mechanically-tenderized-steak/#pings
 FSIS Notice is here: http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/51-09.pdf
 2009 Food Code, Sec. 3-401.11(A)(2); see also Sec. 1-202.10 (defining “mechanically tenderized”). The 2009 Code is at: http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/FoodCode2009/default.htm. Technically-speaking, the Food Code is jointly issued by FDA, CDC, and USDA, but it is the FDA, working with these other two agencies, that has primary responsibility for drafting and issuing the Code.
 2005 Food Code, Sec. 3-401.11(C). This provision remained unchanged in the 2009 Food Code. Notably, this provision goes so far as to prohibit the sale of even intact steaks to “highly susceptible populations” unless the steaks are thoroughly cooked. Further, the Code goes to great length to state that intact steaks may be served in an undercooked (e.g.., medium-rare) condition only if the “steak is cooked on both the top and bottom to a surface temperature of 63º C (145º F) or above and a cooked color change is achieved on all external surfaces.”
 2005 and 2009 Food Code, 3-401(E).
 Not coincidentally, in the wake of this latest recall of mechanically tenderized steaks, a Congresswoman known for her attention to food safety issues, called on the USDA to require labels on all tenderized meat, not only that which goes to restaurants, but all tenderized beef products. As reported in blog Meatingplace:
Congresswoman Rosa DeLauro (D-Conn.) on Monday called for labels identifying mechanically tenderized beef and pork products in the wake of National Steak and Poultry’s recent recall….
The recall followed USDA’s determination of an association between non-intact steaks (blade-tenderized prior to further processing) and illnesses in Colorado, Iowa, Kansas, Michigan, South Dakota and Washington.
“USDA has been aware of the E. coli risks associated with mechanically tenderized steaks as early as 1999, but has refused to act,” DeLauro said in statement. “The USDA should move immediately to require labeling that clearly identifies mechanically tenderized beef and pork products for all processing facilities, retailers and consumers. Restaurants, grocery stores, and consumers should be made fully aware of the products they are receiving so they can assure that they are cooked at the appropriate temperature.
See Rita Jane Gabbett, “Congresswoman calls for tenderized meat labels,” (Dec. 28, 2009), available online at http://www.meatingplace.com/MembersOnly/webNews/details.aspx?item=14991 (sign-in required).