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How does our industry respond to the issues of E. coli O157:H7-laced meat, sicknesses and deaths?  for one, we demand, “Show me the graves!” I suggest that our industry suffers a black eye when we ask for a tour of the E. coli cemeteries, or claim that several E. coli positives per day at large slaughter plants are not cause for alarm, as claimed by the former USDA Under-Secretary Elsa Murano.  Try posing these excuses to Stephanie Smith, Michael and Barbara Kowalczyk, Nancy Donley, or hundreds of other impacted families. our industry is justifiably viewed as callous to consumer interests when our perennial fallback position is to remind consumers that they are ultimately responsible to fully cook our contaminated meat. as such, we immunize ourselves from the responsibility to produce feces-free meat, and mandate that all our ignoramus customers fully cook our invisible manure.  how does FSIS respond to the same issues?  At an industry conference in Chicago Sept. 16-17, 2008, the agency clarified its view on E. coli O157:H7 testing results.  in a PowerPoint  presentation, ”FSIS Framework for Event Days,” by Dr. Daniel Engeljohn from the agency’s Policy and Program Development staff, the following interesting statement was given to the conference’s participants:”2 in 24 or 4 in 98 N60 samples could represent a cluster of positives potentially (emphasis added) evidencing insanitary conditions.”  The term “event day” is much worse than a bad hair day.  To FSIS, an event day signifies that on one day, a plant experiences such a high number of food safety violations that the agency would be justified to initiate enforcement actions.To simplify, Engeljohn stated that if 4 out of 98 tests (4.1 percent) of boneless trimmings were positive for E. coli O157:H7, these lab results could “potentially” indicate insanitary conditions at the plant.  not a definitive indication of insanitary conditions, only “potentially.”  therefore, if only 3 out of 98 tests were adverse, that 3.1 percent positive ratio would NOT indicate potentially insanitary conditions.in 1994, FSIS classified E. coli O157:H7 in raw ground beef as an adulterant, making the production of meat laced with it a felony. as a result, plants are less willing to test for the pathogen, even less willing to release results to FSIS. This plight is exacerbated at downstream further processing plants.when tests at such downline grinding plants are positive for E. coli O157:H7, true science would dictate that an unrestricted search for the source of the E. coli commence immediately.  unfortunately, the history of FSIS actions reveals that the investigations commence, and finish, at the further processing plant.The cause of public health will benefit from:1.Tracebacks to the source2.Requiring the source to implement corrective actions3.All non-O157:H7 Shiga-toxin producing E. coli (STEC) should be classified by FSIS in the same category as O157:H7. they are all lethal killers. and since CDC statistics show that Salmonella kills 10 times more Americans every year than E. coli O157:H7, Salmonella belongs in the same classification. This will force FSIS to reconsider its ill-designed Zero Tolerance Policy.Frankly, we need to develop incentives for all plants, especially slaughter plants, to test for STEC, and provide all results to FSIS. Adverse lab positives need to be traced back to the one particular step in the production process that failed. Then, slaughter establishments must devise a stratagem to reduce such contamination, realizing that full removal of pathogens will probably be impossible, at least in raw meat and poultry.as long as the slaughter plants are transparent with FSIS in their pathogen intervention steps and test results, and continue to experience a gradual trend of improvement in controlling STEC, FSIS should not charge them with felonies. Granted, slaughter plants must still be held fully responsible for pathogens that slip through the cracks, get shipped into commerce, and cause consumer illnesses.therefore, just how beneficial was the agency’s classifying E. coli O157:H7 as an “adulterant?”  we still experience ongoing outbreaks and recurring recalls. Plants are reluctant to share test results. FSIS still primarily focuses its investigations at the downstream destination plants, rather than at the source slaughter plants.Frankly, we can’t regulate our way to safe food.  however, FSIS desires to regulate its way to food safety, because it no longer wants to inspect its way to food safety.  The issuance of a regulation is much easier and more comfortable for the agency, compared to intensive inspection of meat production lines.It is interesting to note that Pillsbury’s HACCP protocol was always meant to be a voluntary system, for plants that qualify, requiring kill steps.  FSIS however mandates that ALL USDA-inspected plants implement FSIS-style HACCP, even those which produce raw meat, which automatically disqualifies them from true HACCP.  I’ve heard no one defend the idea of Zero Tolerance in raw meat and poultry.if we can indeed mandate or regulate our way to safe food, then FSIS should mandate that all E. coli O157:H7 bacteria be homogeneously dispersed throughout a batch of meat prior to sampling, ensuring that the pathogen will be detected in the lab test. This would be impractical and impossible. It does show however that we can’t regulate our way to consistently safe food in raw meat and poultry.we need a partnership between the industry and the agency. Sadly, FSIS-style HACCP prevents such a partnership since the agency must be “hands off.” an open dialogue, true science, transparency, and empowering inspectors to document visible insanitary conditions will be much more successful to promote public health goals than broadly sweeping agency regulatory actions. none of these four exists under FSIS-style HACCP.   The PowerPoint presentation in Chicago revealed that the agency openly allows E. coli at a level less than 4.1 percent, and that its Zero Tolerance mandate is history, at least at the big plants. These statistics also reveal that the agency concludes that an “event day” required for the agency to initiate enforcement actions requires that at least 4.1 percent of tests are positive for E .coli 0157:H7, and that such a percentage only constitutes a day that “could potentially” reveal insanitary conditions.It also means that when E. coli O157:H7 is detected in only 3.1 percent or less of tests, that the pathogen really isn’t a danger, probably incapable of injuring a consumer, so the agency ignores its presence.  I felt that FSIS was overly kind to the industry when the agency publicly admitted that a 3.1 percent  positive ratio is essentially no cause for concern.  So, how did the industry respond to this liberalized agency stance of disinterest?  At an FSIS-sponsored public hearing to discuss tracebacks on March 10, 2010, the American Meat Institute (AMI) provided public comments, which included the following statement:”AMI remains committed that the predetermined number of positive test results to describe a high event period for an establishment, as previously mentioned by FSIS, has no basis.”Shockingly, AMI is not content with the agency’s free gift of 3.1 percent positives. To add insult to consumer injury, AMI contends that its member plants should have the right to experience more than a 3.1 percent incidence of positive test results before FSIS has the right to confront the plant’s adverse lab findings.as stated earlier, former USDA Undersecretary Elsa Murano said ConAgra produced 800,000 pounds of boneless trim daily; 3.1 percent of 800,000 pounds is 24,800 pounds of  E. coli-contaminated meat, which could be shipped daily from one plant with tacit FSIS endorsement, with no need for FSIS enforcement action or corrective actions at the plant.”That is not that high a number,” to again quote Murano. once we understand this agency stance, why did FSIS shutter my grinder for four months, over 270 pounds? why has FSIS initiated aggressive enforcement actions against dozens of other small plants for producing infinitesimally smaller volumes of ground beef? answer:  ”hands off” … for large plants. Size covers a multitude of sins.unfortunately, historical agency statements tend to side with AMI’s stance. for example, FSIS sent a letter to nine industry associations on March 19, 2010 regarding the need for meat plants to validate the efficacy of their individual HACCP Plans. The letter made several references to the need for downstream further processing plants to test incoming meat (from source slaughter providers) for the presence of pathogens. Examples include:”For example, collecting data on initial and finished product microbial loads using an appropriate indicator to demonstrate a log reduction capability…”  Interpretation: FSIS wants further processing plants to test incoming meat purchased from source slaughter providers, even though the incoming meat bears the official USDA Mark of Inspection, and the meat emanated from a plant with a validated HACCP Plan.  ”These data can be used to demonstrate that a process, as designed, will mitigate to a specified extent a food safety hazard occurring in the raw materials that the establishment typically receives.” Interpretation:  FSIS admits that incoming raw materials, which arrive at downstream further processing plants frequently, harbor invisible food safety hazards.  ”These [microbial] data can be used to determine whether the process is able to reduce the level of pathogens associated with the raw materials received at the establishment…”FSIS repeatedly acknowledges that pathogen-laced meat is being shipped into commerce, destined for downstream further processing plants.  what is the solution to this obvious public health danger?  answer:  FSIS contends that the downstream destination plants are responsible to detect and remove the invisible pathogens from incoming meat.  why?  Because FSIS now allows the source slaughter plants to produce up to 3.1 percent OR MORE of its meat with pathogens, even adulterants, and the agency refuses to confront the large source slaughter plants with meaningful enforcement actions.The small downstream plants are much easier enforcement prey, and can be easily manipulated.  interestingly, although neither the source slaughter plant nor FSIS were able to detect or remove pathogens at the source, the agency now expects downstream plants to accomplish both of these functions.another reason for this crazier-than-fiction soap opera is because FSIS proactively embraces its “hands off” non-involvement, semi-retirement role at the large source slaughter plants.  The March 19, 2010 Validation Letter also refers to a “Prudent Establishment,” which is but a continuation of the agency’s historical expectations at so-called “prudent” downstream further processing establishments. in a letter issued by Dr. Kenneth Petersen, then-Deputy Assistant Administrator in the agency’s Office of Field Operations on June 2, 2003, the following statement is found:”I would expect a prudent (emphasis added) establishment to have appropriate procedures to determine product acceptability prior to receiving the product.”  Interpretation: Prudent establishments must maintain full control over the wholesomeness of incoming meat PRIOR to their reception of the meat.  Small downstream plants, which are the destination of meat emanating from source supplier slaughter plants, have virtually NO control over sanitation conditions at their supplier plants.  bottom line:  FSIS openly allows the production of pathogen-laced meat at the large source slaughter provider plants, and now demands that the small, downstream plants sanitize the incoming meat which is already laced with pathogens.  FSIS knowingly allows the horses out of the barn, then dedicates agency resources to detect the horses out in commerce somewhere.This ugly fact was publicly debated during litigation between Excel, Sizzler’s Restaurant and the estate of Brianna Kriefall.  Brianna died of E. coli O157:H7 complications at the age of six, after having eaten at a Sizzler’s restaurant.  The investigation revealed that the E. coli emanated from Beef Tri Tips that the restaurant had purchased from Excel’s slaughter plant in Fort Morgan, CO.  in a superlative article written of the trial by attorney Denis Stearns, the following statements were made:”The uniform national standards governing the production of raw meat expressly provide that whole-intact meat containing E. coli may be distributed for consumption in interstate commerce. This is because, although pathogenic bacteria (such as E. coli) occurs naturally in the production of meat (and is virtually impossible to avoid), safe food-handling readily destroy the bacteria. instead of requiring meat producers to do the impossible (by completely eliminating pathogenic bacteria), the federal government relies on the end-user to follow safe food-handling practices to avoid the dangers associated with raw meat.”  ”In short, according to Excel and its Meat Industry cohorts, the federal government affirmatively authorized the distribution of meat contaminated with E. coli O157:H7, and provided that it was the consumer’s responsibility to ensure the safety of the meat consumed.”  Excel and its meat industry cohorts were precisely correct in the legal claim that E. coli O157:H7 is virtually impossible to avoid, but they failed to further explain that such impossibility applies only to raw meat and poultry. E. coli O157:H7 is eliminated in Pillsbury-style HACCP Plans, because they utilize a kill step. USDA-style HACCP does not require a kill step; nevertheless, FSIS attempts to calm consumer concerns by assuring us that all meat and poultry (including raw) is produced under HACCP’s scientific umbrella, so it must be wholesome.by classifying E. coli O157:H7 as an “adulterant,” and disingenuously claiming a “zero tolerance” stance against the pathogen, FSIS gives the impression that the agency can regulate the pathogen out of existence … even in raw meat and poultry.  after 13 years of FSIS-style HACCP, we should be fully cognizant that safety cannot be regulated into meat!  Let me explain this in lay terms. Excel was correct in its claim that FSIS expressly authorizes the source-originating slaughter plants to ship into commerce intact cuts of meat that are surface-contaminated with E. coli 0157:H7.But to explain the implications of this short-sighted agency policy, let’s follow the trail of the intact cut of meat, and review what happens to these E. coli O157:H7 bacteria that are found on the surface of intact meat cuts shipped into commerce by the source-originating slaughter plants, with full agency endorsement.  Let’s assume a retail meat market purchases beef top inside rounds, which are an intact cut of meat.  Let’s further assume that E. coli 0157:H7 bacteria reside on the exterior surface of these intact cuts.  an employee of the meat market opens the vacuum-pack bag in which the intact cut of meat is packaged, removes the meat, throws the empty bag away, and places the meat on his/her meat cutting table or power saw for processing.At this point, the E. coli bacteria have already cross-contaminated the meat cutter’s gloves, apron, the cutting table and the power saw.  The meat cutter deftly processes the meat into round steak, round roasts, cube steaks, stew and the trimmings go into ground beef.  a meat wrapper then wraps the pieces, and places the finished product into the meat case.now, the E. coli have likewise cross-contaminated the meat wrapper’s gloves and apron, as well as the wrapping station. unfortunately, the bacteria are now on the meat cutter’s knife (blade and handle both), as well as on the power saw when the saw is used.  All meat which subsequently comes in contact later that day with the employees’ aprons and gloves, knives, the wrapping table, the power saws and cutting tables are highly likely to pick up residual E. coli bacteria.we must ask ourselves:  do we now expect both the meat cutter and wrapper to change or sterilize their gloves, aprons, knives, saws, cutting tables and wrapping station before processing the next item?  Realizing that a meat market can process hundreds of meat cuts daily, the inefficiencies required to conduct such sanitizing constitute an impractical alternative.  one FSIS official told me that trimmings (called “bench trim”) derived from processing such intact cuts should be “tanked,” that is, destroyed.  why?  in his own words, because the trimmings emanating from intact cuts are “high risk.”How can this be?  The large source slaughter plants all have FSIS-approved HACCP Plans, have multiple hurdle intervention systems on their kill floors (remember ConAgra’s 7-log reduction claim), have validations performed by impartial and independent outside third parties which supposedly prove that the HACCP Plans successfully produce consistently safe food, virtually sterilizes carcasses, have a superlative cold chain program, etc. therefore, how can FSIS officials state that bench trimmings emanating from further processing intact cuts from these state-of-the-art, cutting edge, scientifically marvelous slaughter plants be high risk?  I must interject here that E. coli come from animals’ intestines and manure-covered hides. Retail meat markets, restaurants, hospital cafeterias and the majority of USDA-inspected plants do not have intestines or hides on their premises. therefore, the very act of further processing intact cuts does not introduce E. coli, a most important distinction. instead, invisible E. coli 0157:H7 bacteria arrive at the retail meat market already residing on the exterior of intact cuts, in boneless trimmings and in coarse ground beef.when the cuts are further processed, a veritable chain reaction of cross contamination occurs, which can cross-contaminate all product subsequently processed on the equipment later in the day.  if indeed the trimmings are high risk, as the agency claims, this means the boxed beef is high risk when it arrives at the retail meat market.  FSIS contends that the boxed beef laced with E. coli O157:H7 is wholesome, but that the act of further processing adulterates the meat.  It works like this:FSIS believes that E. coli O157:H7 residing on the exterior of intact cuts are relatively harmless contaminants. But during further processing activities, these heretofore harmless bugs somehow supernaturally morph into lethal adulterants, all because of further processing activities. This is the precise legal argument made by Excel and the meat industry in the Sizzlers litigation.  we now understand precisely why FSIS sent out its ill-fated “Validation Letter” on March 19, 2010, requiring downstream further processing establishments to test incoming products purchased from the source slaughter plants.  we can now understand why the agency contends that bench trimmings derived from processing intact cuts are high risk.  in actuality, ALL meat emanating from high-speed source slaughter plants is high risk, enjoying the agency’s full endorsement as these “USDA Inspected and Passed” pathogens course through commerce.  Consumers also purchase intact cuts, such as rib eyes, tenderloin, sirloin butts, new York strips, briskets, etc., to take home.  The identical cross contamination scenario is duplicated in thousands of consumer kitchens daily.  when the consumer removes the meat from the vacuum bag, and throws the bag into the garbage, drops of contaminated liquid may fall to the floor or onto the counter top.  Baby Susie crawls by thereafter, placing her hands on the juices, and then puts her hand into her mouth.Consumers have been falsely led to believe that the USDA Mark of Inspection has a connection with safe, sanitary food.  Let’s go back to the agency’s suggestion that all bench trim should be destroyed.  what impact would this agency idea have on my small plant? one item we made was a beef steak strip, just like a chicken strip, only made from beef inside top rounds. one 8-hour shift produced 700 pounds of round steak trimmings, which make beautifully textured 85 percent lean ground round.At today’s prices, 700 pounds of such ground beef has a value of more than $1,400. well, destroying such meat would quickly destroy my plant’s ability to survive. is America to blithely destroy good food, all because FSIS allows source slaughter plants to ship into commerce intact cuts of meat that are knowingly contaminated with E. coli O157:H7?At an industry conference in Chicago, Sept 16-17, 2008, then-USDA Under Secretary Dr. Richard Raymond was the speaker at a noon luncheon. he stated that the agency had conducted a microbial sampling experiment in which the agency opened 24 packages of intact vacuum-packed meat and tested them for E .coli 0157:H7.Shockingly, meat in eight of the 24 packages tested positive for E. coli O157:H7, and six of the eight were loin cuts.Indeed, we can better understand why the agency contends that trimmings emanating from further processing of boxed beef are high risk, whereas the boxed beef itself should be considered high risk. I subsequently have asked FSIS on two occasions to provide me details of this agency experiment but, to date, have received no reply. These details are top secret, and embarrassing, so not available to American citizens. what we don’t know won’t hurt us.Authorizing shipment of intact meat into commerce, which is surface-contaminated with E. coli O157:H7, has global repercussions FSIS would rather not confront.  Foreign countries desiring to export their meat to America must have HACCP systems “equivalent” to FSIS-style HACCP protocol. therefore, those countries can ship E. coli O157:H7-laced intact meat cuts to America!Case in point:  on Sept. 29, 2007, TOPPS Meat Company in Elizabeth, new Jersey, recalled 21.7 million pounds of meat potentially contaminated with E. coli O157:H7.  TOPPS did not slaughter, but purchased all its meat from outside source slaughter providers. Subsequent investigations revealed that the contaminated meat TOPPS had purchased originated from Ranchers Beef, a Canadian firm.The Ranchers Beef meat was intact beef cuts, classified as “Boxed Sub-Primal Cuts.”  by FSIS definition, the E. coli O157:H7 bugs on the surface of these intact cuts were not injurious to public health.  With full endorsement of FSIS and other global food safety agencies, countries can ship to the U.S. intact cuts of meat that are surface-contaminated with E. coli O157:H7.  Consumers are paying dearly for this “free trade.” we now enjoy a global, dumbed down, deregulated, allegedly “science-based” system of “hands off” meat non-inspection of raw meat and poultry.  To the agency’s credit, it is authoring a greatly modified Validation Letter, more than a year since the issuance of its initial fiasco.  It promises to be interesting. if FSIS attempts to trace back to the upstream source of contamination, the agency will encounter the legal fight of its life.  But let’s see what the USDA’s own OIG says about “prudence” within FSIS-style HACCP.  I previously referred to the executive summary of OIG’s June, 2000 investigation of the FSIS implementation of HACCP.  The executive summary states, in part:”We [OIG] believe prudent oversight requires FSIS to be aware of all positive test results, generic or otherwise.”  FSIS disagrees. The agency covets comfort, which is accomplished via ignorance of obvious truths, as proven in the OIG investigative report of the ConAgra recall. FSIS prefers to be ignorant of obvious truth at the large, source originating slaughter plants. Because of this, adulterated meat continues to be shipped into commerce, in containers bearing the official USDA Mark of Inspection, from which we continue to experience multiple outbreaks.  This brings into question the value, if any, of the USDA Mark of Inspection, which states “USDA Inspected and Passed Est # xxxx.” for many years I included in my radio and newspaper advertising that my plant was USDA-Inspected, and thought the Mark of Inspection had some marketing value. since June 2008, FSIS must be credited with finally acknowledging the limited value of the mark. in June 2008, the agency sent a PowerPoint presentation to its field force for training purposes. The title of the PowerPoint was “Prerequisite Programs for E. coli 0157:H7.” The headline on the top of slide 2 says “Basic Principles.” The next sentence stated, “Grinders with prerequisite programs should not rely on the mark of inspection to accept incoming product.” as bewildering as this agency admission is, we must congratulate the agency for its refreshing candor in admitting the Mark of Inspection is valueless.on Jan. 7, 2009, FSIS issued Notice 05-09.  part II (A) states “An establishment that receives, grinds, or otherwise processes raw beef products cannot conclude that E. coli O157:H7 is not reasonably likely to occur in its production process because the product it receives bears the mark of inspection.” Yet, it can’t be otherwise, because the agency aggressively promotes its “hands off” non-involvement role under its bastardized version of HACCP.  I have a copy of a cookbook published in 1998 entitled “America’s Favorite Beef Recipes,” compiled by the National Cattlemen’s Beef Association.  The following statements are found on page 6:”First, the wholesomeness of our meat supply is ensured (emphasis added) by meat inspection conducted by the U.S. Department of Agriculture (USDA).”"All meat that is sold, must, by law, pass inspection.”"Inspection provides assurance that all meat sold is wholesome (emphasis added) and accurately labeled.”I am no prophet, but I predict that we will not see such a claim again, as long as we suffer under the existing corrupted style of FSIS HACCP.  after ConAgra’s 19.1 million pound recall in July 2002, we witnessed a variety of embarrassing revelations.  once the Minneapolis District Office had a change of heart, and allowed me to grind again under the Mark of Inspection, I was seething within because of the agency’s overtly corrupt handling of my plant. I was faced with a discomforting dilemma: should I let dead dogs lie, and go on with business, grateful that I was finally able to operate again in the absence of the agency’s artificial grinding restrictions against me? Or, should I go public, and hope that a potential public outcry would force FSIS to greatly modifying its faulty HACCP Hoax, which would result in safer meat products?  The risk was obvious:  if I revealed it all, FSIS could very well launch unending witch hunts against me, and would certainly be successful in closing me down for tenuous reasons.  I lack the staff and financial largesse to tackle this monster of an agency, I would be a veritable David vs Goliath with little chance of success.  But, if I chose to ignore the obvious problems permeating the FSIS-style HACCP Hoax, and consumers continue to be sickened, I would be at least partially responsible for those future sicknesses because of my cowardice to publicly admit the full truth.what was I to do?  I didn’t want to lose my business, but I also didn’t want to become a silent accomplice to the agency’s shielding the large source slaughter plants from accountability.  my grandkids came into play here, nudging me in the direction I should go, which will be discussed in the next part.————————