Blatantly (and self-servingly) rewriting history, in Friday’s Wall Street Journal, the USDA is reported as stating the following:
The USDA has been considering for more than a year a policy change that would allow whole beef cuts to be considered "adulterated" — and thus subject to recall — even if they aren’t "intended for use in ground beef," according to Daniel Engeljohn, a deputy assistant administrator for USDA’s Food Safety and Inspection Service, or FSIS.
The policy change is still under consideration, he said.
See Bill Tomson, U.S. Beef Safety Plan Languishes Amid New Illnesses, Wall Street Journal, July 10, 2009, see: online.wsj.com/article/SB124725846273124757.html
Despite the fact that it has been pressed on the problem for over eight years, the USDA is now trying to act as if the serious risk of E. coli O157:H7 contamination of primal and subprimals, so-called intact cuts of meat, is a recent problem that is currently subject to ongoing policy review. This, to put it mildly (and aptly), is a bunch of cow-sh*t. Confusion has reigned since the FSIS E. coli O157:H7 policy on intact vs. non-intact meat was first announced on January 19, 1999. See 64 Fed. Reg. No. 11, 2803-05, see ftp.resource.org/gpo.gov/register/1999/1999_2805.pdf (hereinafter “Intact Meat Policy Statement)”.
For a complete and accurate history of how long this issue has been before the USDA, without it taking any action to address the risk, please click on the Continue Reading link.
Following Texas Food Industry v. Espy, which upheld the USDA decision to treat E. coli O157:H7 as an adulterant in raw meat “in light of the common cooking practices of most Americans,” the Agency stated in its Non-Intact Meat Policy Statement, published in the Federal Register on January 19, 1999, that it "believes the status under Federal Meat Inspection Act (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." Intact Meat Policy Statement at 2803.
In its policy statement, the Agency provided no statutory basis for its authority to define adulteration on a product-specific basis. Nor did the Agency expressly state that E. coli O157:H7 was no longer an adulterant per se. Instead, it stated that:
[USDA] believes that with the exception of beef products that are intact cuts of muscle that are to be distributed for consumption as intact cuts, an E. coli O157:H7-contaminated beef product must not be distributed until it has been processed into a ready-to-eat product—i.e., a food product that may be consumed safely without any further cooking or other preparation. Id at 2804.
Accordingly, based on the input it received, the Agency announced that it would consider expanding its sampling and testing program to include non-intact beef products or intact cuts of meat that are to be further processed into non-intact cuts. Id.
The corollary of the Agency’s position was that, while it would treat non-intact meat as “adulterated” if contaminated with E. coli O157:H7, it would not treat intact meat as “adulterated” if it was identically contaminated. Id. (“such intact products that are to be distributed for consumption as intact cuts are not deemed adulterated.”) Essentially, the Agency had therefore created an exception to its E. coli O157:H7 policy for an entire product-category—intact meat. The Agency defined the category by exclusion as “cuts of muscle include steaks, roast, and other intact cuts (e.g., briskets, stew beef, and beef ‘cubes for stew’, as well as thin-sliced strips of beef for stir-frying) in which the meat interior remains protected from pathogens migrating below the exterior surface.” Id.
The definition of “intact meat” is explicit in its reliance on the deliberations of the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) and the work it did for FDA and USDA 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 Non-Intact Meat Policy Statement regarding intact product:
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.”Id. at 2803-04. See also 1999 Model Food Code, 3-201.11(E), at vm.cfsan.fda.gov/~dms/fc99-3.html (defining “whole-muscle intact beef steaks” as those “that are intended for consumption in an undercooked form without a consumer advisory”).
Therefore, intact meat is any meat that is not non-intact, and vice versa.
Recognizing the utility of excluding entire product-categories from the USDA’s E. coli O157:H7 policy, the meat industry soon began to press the Agency to also exclude mechanically-tenderized meat from the policy. The meat industry sponsored research intended to show the safety of this second category of meat products. Wendy Warren, Characterization of E. coli O157:H7 on Subprimal Beef Cuts Prior to Mechanical Tenderization: Project Summary (Aug. 2002), at www.beef.org/uDocs/E.%20coli%20Mech%20Tenderization_Warren_6_6_03.pdf (stating on title page “Funded by America’s Beef Producers”).
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.” E. Coli O157:H7 Contamination of Beef Products, 67 Fed. Reg. 62,325, 62,333 (Oct. 7, 2002). 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.
As a result, the focus continued to be placed upon cooking and nothing else. The extremely low infectious-dose made cross-contamination as big a risk as undercooking. At least in the case of cross-contamination risk, the Agency remained steadfast in its position.
Two years later an outbreak of E. coli O157:H7 infections was linked to non-intact blade tenderized steaks. 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”). Nevertheless, the Agency continued to consider further narrowing the products subject to its E. coli O157:H7 per se adulteration standard. After having first set forth a zero-tolerance policy for this deadly pathogen, the Agency proceeded with an approach designed to satisfy the meat industry rather than protect the public from a known risk.
This risk became even better known in 2000 when, in Milwaukee, there were over 62 lab-confirmed E. coli O157:H7 infections linked to a Sizzler restaurant where cross-contamination from intact cuts of meat caused other ready-to-eat food items to turn deadly. Tragically, one young child, Brianne Kriefall died as a result of her infection.
Wisconsin health investigators later concluded Brianna Kriefall died from eating watermelon that Sizzler workers had inadvertently splattered with juices from tainted sirloin tips. The meat came from a Colorado slaughterhouse where beef repeatedly had been contaminated with feces, [E. coli]’s favorite breeding ground. Federal inspectors had known of the problems at the plant and had documented them dozens of times. But ultimately they were unable to fix them.).
Joby Warrick, An Outbreak Waiting to Happen: Beef-Inspection Failures Let In a Deadly Microbe, Wash. Post, Apr. 9, 2001, at A1.
In the resulting litigation, the defendant meat company, Excel Meat Corporation, a subsidiary of Cargill, argued that it could not be held legally liable for the injuries because the USDA authorized it to sell intact cuts of meat contaminated with E. coli O157:H7, citing the Intact Meat Policy Statement discussed above. The trial court agreed and dismissed all claims, but the Court of Appeals reversed, finding, among other things, that the USDA had no jurisdiction to treat E. coli O157:H7 as an adulterant on some meat but not others. The court also found that the actual policy of the USDA was a zero-tolerance one, notwithstanding the Agency’s conflicting statements regarding enforcement policy to the contrary. Estate of Kriefall ex rel. Kriefall v. Sizzler USA Franchise, Inc., 671 N.W.2d 849 (Wis. 2003) (denying petition for review); Excel Corp. v. Estate of Kriefall, 541 U.S. 956 (2004) (denying Excel’s petition for writ of certiorari).
While the litigation and appeals were pending, I filed a petition with the USDA seeking a clarification of its policy on intact meat and E. coli O157:H7. A copy of that Petition can be found here: www.fsis.usda.gov/OPPDE/Comments/02-022N/00-022N-12.pdf Among the many points made in the Petition is one in which I emphasized that substantial amounts of intact meat end up being used to make ground beef at retail. This, I argued, was contrary to the Agency’s own stated position that the policy was to allow the pathogen to be present only if the meat was to be distributed for consumption as an intact cut. This was plainly not the case, however, with intact cuts sold to restaurants and grocery stores.
In response to my Petition, the USDA simply punted, stating that “because the issues raised in your petition are related to the matters discussed in the October 7, 2002 notice [67 FR 62325], the Agency will consider your petition in conjunction with the comments received in response to that document.” And that was over five years ago.
The final bit of history that gives lie to Mr. Englejohn’s statements concerning supposedly ongoing policy review is the fact that the FSIS issued a draft risk assessment report on E. coli O157:H7 and ground beef, titled Preliminary Pathways and Data for a Risk Assessment of E. coli O157:H7 in Beef, on October 28, 1998—over ten years ago. See www.fsis.usda.gov/Ophs/ecolrisk/prelim.htm It then submitted the draft for scientific peer-review to the National Academy of Sciences. This review found numerous shortcomings, including, not surprisingly, the complete failure to take into account the risk of cross-contamination as a vehicle of infection. See, e.g. National Academy of Science, Escherichia coli O157:H7 in Ground Beef: Review of a Draft Risk Assessment, Executive Summary, at 7 (noting that the lack of data concerning the impact of cross-contamination of E. coli O157:H7 during food preparation was a flaw in the Agency’s risk-assessment), available at www.nap.edu/books/0309086272/html/
Then, as announced in October 7, 2002 notice (the one cited in response to my Petition), the USDA noted that, “On November 5, 2001, FSIS announced the availability of and requested comments on its draft risk assessment for E. coli O157:H7 in ground beef (66 FR 55912).” There it also stated that “FSIS believes that the availability of certain scientific data on E. coli O157:H7 constitutes a change that could affect an establishment’s hazard analysis or alter its HACCP plans for raw beef products.” See E. coli O157:H7 Contamination of Beef Products, 67 Fed. Reg. 62325, at www.fsis.usda.gov/oppde/rdad/frpubs/00-022n.htm Here, tellingly, again over five years ago, in 2002, the USDA stated:
The Agency stated that if non-intact products or intact products that are to be further processed into non-intact product prior to distribution for consumption are found to be contaminated with E. coli O157:H7, they must be processed into ready-to-eat product, or they would be deemed to be adulterated (64 FR 2804). FSIS explained that pathogens, including E. coli O157:H7, may be introduced below the surfaces of non-intact products as the result of the processes by which they are made. As a result, customary cooking of these products may not be adequate to kill the pathogens. In contrast, the meat interior of intact products remains protected from pathogens migrating below the exterior. Consequently, customary cooking of these products will destroy any E. coli O157:H7. Finally, in this Federal Register notice, FSIS requested comments and recommendations relevant to the Agency’s policy and to any regulatory requirements that might be appropriate to prevent the distribution of beef products adulterated with this pathogen.
Id. at 62326 (emphases added).
Thus, it seems plain as day, that the FSIS policy has always been, at most, that intact cuts distributed FOR CONSUMPTION as intact cuts might reasonably be treated as not adulterated, but nothing else. There is no, and has been no, rational basis for FSIS to somehow claim that intact cuts that are destined for purposes other than consumption AS INTACT CUTS.
Of course, all of this ignores why the USDA thinks it has the authority to pick and choose what meat it considers to be adulterated when it comes to E. coli O157:H7. To-date, the only court that has been asked to answer that question has ruled that the USDA lacks the authority for this very policy. Perhaps it is time to put this question to the test in a declaratory action against the USDA. Maybe that will get more of a response that my petition did many years ago.