E. coli O157:H7 is Baaaaaack in Red Meat
In August 2002, I wrote an Op-ed for the Denver Post entitled “Put me out of business - please.” That summer, the now infamous ConAgra case, started with a few sick kids in Colorado and quickly spread coast-to-coast, eventually triggering the recall of over 19,000,000 pounds of ground beef tainted with E. coli O157:H7. I asked, no pleaded, that the government and industry adopt measures to prevent illnesses. I asked:
1. Actually, inspect and sample meat. At present, the USDA employs thousands of inspectors across the nation to inspect hundreds of plants that produce millions of pounds of beef at processing plants and retail outlets. The GAO has warned that the USDA's food samplings are so scattered and infrequent that there is little chance of detecting microscopic E. coli or any other pathogen.
2. Consider mandatory recall authority. This authority is required in Sen. Tom Harkin's Safer Meat, Poultry and Foods Act of 2002 (named Kevin’s law for a young boy who died of E. coli that year).
3. Require the meat industry to document where specific lots of food are sold. That way, it can be recalled quickly if a pathogen is detected. In most E. coli outbreaks, there is no recall because retailers do not know where the meat came from and processors rarely step forward.
4. Merge the two federal agencies responsible for food safety. Right now, USDA's Food Safety Inspection Service and the inspection arm of the Food and Drug Administration share this mission. The system is bifurcated, which leads to turf wars and split responsibilities. We need one independent agency that deals with food-borne pathogens.
5. Finally, large purchasers of meat – fast food industry, grocery store chains, and yes, the USDA – must require the meat industry to produce high quality, pathogen lessened, meat.
From 2002 until a few weeks ago I believed that even though most of the measures above never fully occurred, E. coli illnesses, especially those tied to red meat consumption were down - way down. A report in 2005 released by the CDC, in collaboration with the FDA and USDA, showed important declines in foodborne infections due to common bacterial pathogens in 2004. From 1996-2004, the incidence of E. coli O157:H7 infections decreased 42 percent.
Now that was, and still seems, significant. We saw the same results in our law firm. From 1993 (Jack in the Box) to 2002 (ConAgra), 95% of the cases in our office were E. coli cases tied to red meat consumption. After 2002, we saw enormous drop in clients, and more importantly, ill people nationwide. Recalls fell to nothing. That is until six weeks ago.
The last three months look like the late springs and summers from 1993 to 2002, when hamburger recalls and E. coli illnesses were a large part of every summer – much like vacations and baseball season. Now here is the concerning reality of 2007:
- Abbott's Meat Inc., a Flint, Mich., establishment, recalled approximately 26,669 pounds of ground beef products because they may be contaminated with E. coli O157:H7.
- At least thirteen people have been confirmed ill with E. coli O157:H7 infections after eating ground beef produced by United Food Group sold in Arizona, California, Colorado, Idaho, Nevada, New Mexico, Oregon, Utah, Washington, Wyoming and Montana. Over 5,700,000 pound of meat have been recalled.
- Tyson Fresh Meats, Inc. recalled 40,440 pounds of ground beef products due to possible contamination with E. coli O157:H7. No illnesses yet reported.
- Seven Minnesotans were confirmed as part of the E. coli O157:H7 outbreak that prompted PM Beef Holdings to recall 117,500 pounds of beef trim products that was ground and sold at Lunds and Byerly’s stores.
- Twenty-seven people have been confirmed ill with E. coli O157:H7 infections in Fresno County. The Fresno County Department of Community Health inspected the “Meat Market” in Northwest Fresno, the source of the outbreak.
- At least two people were confirmed ill with E. coli O157:H7 infections in Michigan after eating ground beef produced by Davis Creek Meats and Seafood of Kalamazoo, Michigan. The E. coli outbreak prompted Davis Creek Meats and Seafood to recall approximately 129,000 pounds of beef products that were distributed in Arkansas, Florida, Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Missouri, Ohio, Pennsylvania, Tennessee, Virginia, West Virginia, and Wisconsin.
- Several people were confirmed ill with E. coli O157:H7 infections in Pennsylvania after eating E. coli-contaminated meat products at Hoss’s Family Steak and Sea Restaurants, a Pennsylvania-based restaurant chain that purchased its meat from HFX, Inc., of South Claysburg, Pennsylvania. As a result of the outbreak, HFX recalled approximately 4,900 pounds of meat products.
I am not sure I know the reason for the new and ominous trend (these are the largest meat recalls in five years), but by anyone’s count these numbers are concerning. What I do know is that these recent outbreaks have all the ugly signs of another national emergency. As a nation - and that includes all federal and local government agencies as well as the private sector – we cannot let the positive tend of the past become another acceptable body count. We need to figure out why this has happened. My suggestion – if Congress was willing to drop everything in order to investigate the deaths of a dozen cats due to contaminated pet food from China – perhaps bringing all the executives of the companies responsible for this recent rash of outbreaks, recalls and illnesses to Washington for a few days of questioning (under oath) might help us get to the bottom of this.
1. Actually, inspect and sample meat. At present, the USDA employs thousands of inspectors across the nation to inspect hundreds of plants that produce millions of pounds of beef at processing plants and retail outlets. The GAO has warned that the USDA's food samplings are so scattered and infrequent that there is little chance of detecting microscopic E. coli or any other pathogen.
2. Consider mandatory recall authority. This authority is required in Sen. Tom Harkin's Safer Meat, Poultry and Foods Act of 2002 (named Kevin’s law for a young boy who died of E. coli that year).
3. Require the meat industry to document where specific lots of food are sold. That way, it can be recalled quickly if a pathogen is detected. In most E. coli outbreaks, there is no recall because retailers do not know where the meat came from and processors rarely step forward.
4. Merge the two federal agencies responsible for food safety. Right now, USDA's Food Safety Inspection Service and the inspection arm of the Food and Drug Administration share this mission. The system is bifurcated, which leads to turf wars and split responsibilities. We need one independent agency that deals with food-borne pathogens.
5. Finally, large purchasers of meat – fast food industry, grocery store chains, and yes, the USDA – must require the meat industry to produce high quality, pathogen lessened, meat.
From 2002 until a few weeks ago I believed that even though most of the measures above never fully occurred, E. coli illnesses, especially those tied to red meat consumption were down - way down. A report in 2005 released by the CDC, in collaboration with the FDA and USDA, showed important declines in foodborne infections due to common bacterial pathogens in 2004. From 1996-2004, the incidence of E. coli O157:H7 infections decreased 42 percent.
Now that was, and still seems, significant. We saw the same results in our law firm. From 1993 (Jack in the Box) to 2002 (ConAgra), 95% of the cases in our office were E. coli cases tied to red meat consumption. After 2002, we saw enormous drop in clients, and more importantly, ill people nationwide. Recalls fell to nothing. That is until six weeks ago.
The last three months look like the late springs and summers from 1993 to 2002, when hamburger recalls and E. coli illnesses were a large part of every summer – much like vacations and baseball season. Now here is the concerning reality of 2007:
- Abbott's Meat Inc., a Flint, Mich., establishment, recalled approximately 26,669 pounds of ground beef products because they may be contaminated with E. coli O157:H7.
- At least thirteen people have been confirmed ill with E. coli O157:H7 infections after eating ground beef produced by United Food Group sold in Arizona, California, Colorado, Idaho, Nevada, New Mexico, Oregon, Utah, Washington, Wyoming and Montana. Over 5,700,000 pound of meat have been recalled.
- Tyson Fresh Meats, Inc. recalled 40,440 pounds of ground beef products due to possible contamination with E. coli O157:H7. No illnesses yet reported.
- Seven Minnesotans were confirmed as part of the E. coli O157:H7 outbreak that prompted PM Beef Holdings to recall 117,500 pounds of beef trim products that was ground and sold at Lunds and Byerly’s stores.
- Twenty-seven people have been confirmed ill with E. coli O157:H7 infections in Fresno County. The Fresno County Department of Community Health inspected the “Meat Market” in Northwest Fresno, the source of the outbreak.
- At least two people were confirmed ill with E. coli O157:H7 infections in Michigan after eating ground beef produced by Davis Creek Meats and Seafood of Kalamazoo, Michigan. The E. coli outbreak prompted Davis Creek Meats and Seafood to recall approximately 129,000 pounds of beef products that were distributed in Arkansas, Florida, Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Missouri, Ohio, Pennsylvania, Tennessee, Virginia, West Virginia, and Wisconsin.
- Several people were confirmed ill with E. coli O157:H7 infections in Pennsylvania after eating E. coli-contaminated meat products at Hoss’s Family Steak and Sea Restaurants, a Pennsylvania-based restaurant chain that purchased its meat from HFX, Inc., of South Claysburg, Pennsylvania. As a result of the outbreak, HFX recalled approximately 4,900 pounds of meat products.
I am not sure I know the reason for the new and ominous trend (these are the largest meat recalls in five years), but by anyone’s count these numbers are concerning. What I do know is that these recent outbreaks have all the ugly signs of another national emergency. As a nation - and that includes all federal and local government agencies as well as the private sector – we cannot let the positive tend of the past become another acceptable body count. We need to figure out why this has happened. My suggestion – if Congress was willing to drop everything in order to investigate the deaths of a dozen cats due to contaminated pet food from China – perhaps bringing all the executives of the companies responsible for this recent rash of outbreaks, recalls and illnesses to Washington for a few days of questioning (under oath) might help us get to the bottom of this.
I well remember reading Mr. Marler's "Put Me Out Of Business" op/ed challenge while I sat in the LAX airport in early July, 2002. Watching the subsequent reductions in E.coli recalls in succeeding years made me think that USDA took Mr. Marler's proposal seriously. Then, 2007 happened.
USDA's current meat inspection program is titled HACCP, as in Hazard Analysis Critical Control Points. It was introduced with lots of fanfare as an allegedly superior "science based" meat inspection system. How did it qualify for such a glamorous designation? Because it was based on a greatly increased incidence of microbiological sampling for invisible pathogens such as E.coli and Salomonella. USDA admitted from day 1 that its role under HACCP would be "Hands Off", and that it would no longer police the industry as plants operating under the HACCP umbrella must police themselves. As history unravelled, plants assumed the majority of microbial testing, saving the beleagured agency the expense. History also revealed that plants assumed the authority to NOT release adverse lab findings to the agency, claiming that microbial test results were proprietary, thus not available for USDA oversight (and enforcement actions).
How serious was the agency about microbial sampling and how willing was it to aggressively implement effective enforcement actions against noncompliant HACCP plants which were experiencing recurring lab positive results for pathogens? The OIG's report in September 2003 of its investigation into the ConAgra recall in June 2002 stated that even though both the agency and ConAgra were cognizant of recurring fecal contamination of carcasses, the USDA took no actions. The OIG report also stated that fecal contamination of carcasses had become a "continuous" problem at ConAgra, but again, no action was taken by the agency. The OIG report also stated that inspection personnel at the plant did not know what authority they had to intervene. How could this happen, realizing that the Federal Meat Inspection Act authorized the USDA to closely monitor and inspect meat and poultry establishments in America?
The "very heart of HACCP" has instituted artificial restraints which limit inspectors' authority, even oversight, of meat inspection production lines. The meat industry has reminded USDA officials many times that the agency promised the industry that USDA would maintain a "Hands Off" status under HACCP. This promise was necessary from the onset in order to obtain industry endorsement of the HACCP concept in the mid-90's. The industry swallowed this delectable morsel hook, line and sinker. USDA has fully lived up to its promise........at the big packing plants. In stark contrast, the agency has greatly increased its scrutiny at small plants. These plants lack the political connections and financial werewithal to engage the agency in protracted litigation when facing unethical agency actions against these small facilities. The increased scrutiny almost always centers on paperwork, a foundational HACCP building block. In fact, when problems such as recalls occur at individual plants, the agency's investigation almost exclusively resides on an intensive review of the plant's written HACCP plan, and on its voluminous flow of daily paperwork. If a problem occurs, USDA concludes that it was the direct result of an inadequately written HACCP plan. Yup, if just one more page had been inserted, or a paragraph rewritten, plants would not be experiencing problems. Close agency oversight of production lines constitute inspection methodologies which were, and are, viewed as antiquated relics from a previous organoleptic meat inspection system which was allegedly "unscientific". Inspectors on kill floors are to see no evil, hear no evil, smell no evil, taste no evil.......because those detections are organoleptic in nature, not "scientific" enough. Instead, we are to rely on microbial test results, which of course the industy is to perform on its own, and allowed to hide the results.
Another game the industry plays with lab tests (with full agency endorsement) is to artificially terminate the tests to prevent " CONFIRMED POSITIVE" determinations of specific E.coli 0157:H7. If a lab test comes back "Potentially Positive", the plant has the right to terminate the test, and not expose the sample to additional testing to determine if it is confirmed positive or confirmed negative. USDA is primarily concerned with confirmed positives. If the test is potential positive, plants often divert the meat to a full cooking operation where heat fully kills the "potential" pathogens. If the test had been allowed to be fully concluded, it could have resulted in the determination that the meat indeed had specific E.coli 0157:H7 residing in it. This might constitute a failure in that plant's production system, and by extension, in the plant's Bible, that is, its written HACCP plan.
The largest plants had to implement HACCP by January 26, 1998. Interestingly, only six days later, USDA issued Directive 10,010.1 which provided an exemption to "qualified" plants from agency-conducted testing for E.coli 0157:H7. (The timing is ironic, and revealing). In order to qualify, meat plants had to have their own microbial testing program in place for pathogens, and to have had zero positives for six consecutive months. ConAgra qualified. Oddly enough, as pointed out by the OIG report, "continuous" production of E.coli-contaminated meat had been occuring at ConAgra prior to its recall. How does this truth reconcile itself with USDA's designating ConAgra as being qualified for exemption from agency-conducted testing?
Most Americans do not know, nor would I expect them to, that E.coli and Salmonella are "Enteric" bacteria, which by definition means they originate from within animals' intestines, and by logical extension, on manure-covered hides. Intestines and dirty hides are business-as-normal at slaughter plants. However, the majority of USDA-inspected plants in America do not slaughter. Such plants merely further process meat which they purchase from upline source supplier slaughter facilities. The ability of these downline further processing plants to produce meat void of enteric pathogens is totally dependent on the wholesomeness of meat they purchase from their slaughterhouse suppliers.
Some of this year's recalls were from the following establishments:
Abbotts Meat in Flint, MI (The most recent recall)
United Food Groups in Vernon, CA. This firm recalled 5.7 million pounds.
Lunds and Byerlys retail stores in Minneapolis.
Davis Creek Meat & Seafood in Kalamazoo, MI
Hoss's Fresh Xpress, in South Claysburg, PA
Richwood Meat Co, in Merced, CA. Mr. Marler's article did not refer to this recall. Interestingly, Richwood Meat Co. experienced a previous E.coli recall in 2004.
What is a common denominator which links these firms together? None of them slaughter! These victimized plants are guilty of assuming that the meat shipped to them in containers bearing the official USDA Mark of Inspection which says "USDA Inspected & Passed" was inspected and wholesome, devoid of enteric pathogens.
First of all, under HACCP, this meat had indeed passed USDA inspection, but in all likelihood had not been inspected. Remember, plants are to police themselves. Watch USDA's public statements closely, and you will notice that the agency does NOT guarantee that meat labeled with the official Mark of Inspection is wholesome. Furthermore, supplier certifications provided to the downline further processing plants by their slaughterhouse suppliers regularly make statements such as:
There is no silver bullet allowing plants to provide a guarantee that all meat is pathogen-free.
In spite of a plants' implementation of every multiple hurdle pathogen intervention system available, no plant can provide a 100% guarantee that all of its meat is free of pathogens.
I believe the above two statements are justified and should not be criticized. They reflect reality. As Elsa Murano accurately stated "There is no such thing as risk-free raw meat". Realizing that thousands of cattle are slaughtered daily at some individual plants, we have to acknowledge that some pathogens will fall through the cracks. We live in a real world. But, HACCP resides in fantasyland. When USDA or plants detect pathogens, USDA focuses their enforcement actions not at the source of contamination, but at the destination. Almost always, the victimized downline further processing plants which unwittingly (and legally) purchase previously-contaminated meat are held to be exclusively liable for the presence of the detected pathogens. Agency investigations start, and are prematurely truncated at the downline further processing (non-slaughter) meat plant.
This flies in the face of USDA's mid-90's motto that food safety must be a "Farm to Fork" continuum. As HACCP has unfolded, and pathogens detected, the agency has changed its defintion to "Further Processing Plant to Fork". The result of USDA's decision to insulate slaughter plants from accountability for the INTRODUCTION of pathogens has been to virtually guarantee multiple future recurrences of the production of contaminated/adulterated meat and its shipment into commerce. Mr. Marler questioned why 2007 has produced so many recalls. The answer may be that the agency has been sweeping under the carpet the detection and revelation of the TRUE ORIGIN of bad meat so long that consumers can no longer safely navigate over the rough carpet terrain anymore.
For a variety of reasons, these downline further processing plants lack the capability of purifying, or dry cleaning the previously-contaminated meat they are innocently purchasing from their slaughterhouse suppliers. We must remember that these pathogens are invisible, a fact which was used by USDA to justify HACCP and its supposed "science-based" microbial sampling protocol. Since these enteric bacteria are indeed invisible, the downline plants cannot detect their presence. A sizeable, and meaningful microbial testing regimen could detect the microbes if the agency would properly implement a testing protocol which would be able to expeditiously traceback to the TRUE ORIGIN of contamination. When the above-named downline plants experienced their recalls this year, if the agency had had in place an effective traceback system, USDA in many cases could have isolated and detected the true slaughterhouse origin of the E.coli pathogen, and been able to implement enforcement actions at the truly noncomplaint slaughterhouses. I've been closely monitoring all press releases, but have yet to see where recalls have occurred at any of the slaughterhouse suppliers to the downstream plants named in the list above. The only exception is that the slaughterhouse supplier to Byerlys and Lunds in Minneapolis was determined, and a recall announced at the slaughterhouse. Please remember however that the investigation which revealed this one slaughterhouse supplier was exclusively conducted by the state of Minnesota which fearlessly displays a firm committment to protect its residents. Minnesota state officials act as though public health and common sense override HACCP constraints.
This year's recall at Richwood Meat Co, mentioned above, is pertinent because it is the second recall at Richwood. Since USDA did not trace back to the slaughterhouse origin of Richwood's bad meat in its previous recall, this year's recall is no surprise because the agency has not yet gone back to the source. Richwood and all the other victimized plants which have suffered recalls in recent years can full well expect to suffer through additional future recalls, because the true source of contamination has not been detected, nor has USDA forced the source plants to clean up their acts. Richwood has been doubly victimized, and its second recall should be a wakeup call to all America that we can expect recurring recalls from the same plants.
This year's plethora of recalls has questioned the credibility of deregulating the meat industry. Some industries may respond correctly to deregulation. The meat industry does not qualify.
The Bioterrosism Act of 2002 requires all domestic manufacturers, distributors and retailers to be able to traceforward one step, and tracebackward two steps. With the exception of the above-named recalls at Byerlys and Lunds, USDA was not able(perhaps not WILLING) to traceback to the true origin of E.coli contamination. The agency's vaunted "Abundance of Caution" does not include a voluntary willingness to implement meaningful traceback protocol.
Consumers do not know that when inspectors collect samples of ground beef at downline further processing plants for microbial testing at USDA labs, the inspectors do NOT document the slaughterhouse origin of the meat being sampled. The official USDA form includes no area in which to document such information, nor has the agency provided written or verbal instructions to its field force to document such evidence. Copious evidence which documents the true origin of enteric bacterial contamination is summarily ignored, with official USDA endorsement. USDA's attitude is that "such documentation would require too much time", and "isn't that important". Mr. Marler, as a direct result of such agency attitudes, 2007 has experienced all these unnecessary recalls. They will continue to be inevitable, and increasing in frequency, as long as USDA refuses to implement enforcement actions AT THE SOURCE.
In July, 2002, immediately after the 19 million pound ConAgra recall, the agency did instruct its inspectors to document the origin of meat being sampled at the time of sample collection. Unfortunately, this common sense, scientific procedure was rescinded a mere two months later "for legal reasons", as publicly stated by a former USDA official. Currently, inspectors request such source information from plant management AFTER the USDA lab has made a confirmed positive conclusion. This requires a minimum four day delay, during which time the trail of evidence has turned cold. This artificial delay prevents the agency from independently validating the accuracy of the "evidence" provided by the plant.
Events of this year clearly reveal that the agency has implemented an "abAndance of caution".
For several years, USDA has proudly proclaimed that its microbial sampling is focused "as close to the consumer as possible". At first blush, this appears to promote public health and consumer safety. It also attemts to portray the agency as the ever-vigilant, 24/7 consumer protector. What the agency has not revealed however is that such testing is conducted as far away from the slaughterhouse as possible. The agency's battle cry should be "Force the Source", not "Insulate the Source".
On December 5, 2006, a USDA/FSIS official publicly stated that the agency would change its focus from finished product testing (ground beef) to boneless trimmings at the originating slaughter plants. The agency justified this change based on results of its previous baseline study of the incidence of E.coli found in boneless trimmings. The study concluded that the incidence of E.coli in trimmings was three times greater than its incidence in finished ground beef. If the agency complies with this change in sampling protocol, perhaps the day will eventually come when the slaughterhouse origins of enteric pathogens will be identified. However, this will not be the biggest obstacle. The most daunting challenge USDA would then face would be mounting the fortitude to require the huge, often multi-national slaughter behemoths to implement effective corrective actions required to prevent recurring production of contaminated/adulterated meat. HACCP has the agency backed into a corner, from which it cannot comfortably extricate itself.
A directly related systemic problem is agency capture. This term describes the condition in which the regulated industry has captured, or enjoys inordinate control over the very agency which supposedly regulates the industry. USDA and the large meat plants are engaged in bilaterally voluntary incest, i.e., they are one big happy family, and yes, they are in bed together, covered by a HACCP comforter. This alliance has provided a whole new definition to "revolving door".
We need another Upton Sinclair. Only this time, the book should focus on a recalcitrant USDA which lacks the courage to fulfil its legislative mandate to protect the public from food-borne outbreaks.
The only way that Marler Clark will be put out of business is if USDA aggressively traces back to the true origin of contamination, and forces the source to clean up its act. As long as the agency continues to blame the downstream destination meat plants for their possession of bad meat, Marler Clark will continue to have more business than it can handle. And, consumers will suffer. And, legitimate small businesses will close their doors.
John W. Munsell
Manager, Foundation for Accountability in Regulatory Enforcement (FARE)
Miles City, MT
July 24, 2007
A few additional comments regarding why 2007 has seen such an uptick in E.coli recalls.
This year's recalls, including the swelling revelations about the current botulism recall have not been the result of inadequately written HACCP plans. Likewise, the potentially linked E.coli recalls in Michigan in May and now in Long Island were not caused by typos and/or unintended ommissions from written HACCP plans. Rather, they were and continue to be caused by failures in production lines, from which the USDA has interestingly been withdrawing itself (under the guise of new & improved "science"). Public health imperatives would best be served by USDA's removing their noses from these theoretical HACCP plans, and resume focusing their scrutiny on faulty production lines which are introducing pathogens into the food chain. Prior to HACCP, meat inspection had been a pathogen chase, but has now degenerated into a paper chase......under the tutelage of HACCP.
Our inadequate inspection of imported goods has resulted in a plethora of human and animal sicknesses. In the same light, our diminished oversight of domestic meat plants has likewise resulted in an increase of domestic pathogen outbreaks.
Think of the beauty of HACCP! Big plants enjoy minimized USDA surveillance, while the agency itself enjoys semi-retirement. Ominously, when outbreaks occur, the agency cannot be held partially responsible for meat which it did not inspect in the first place.
I previously referred to the "relationship" between the big packers and the USDA, snuggled under the conjugal security provided by their HACCP comforter. This partnership has spawned a new generation of genetically-flawed, but allegedly "science-based" chickens (meat inspection policies). Mr. Marler, these HACCP chickens are coming home to roost in 2007. The truth always comes out. Nixon had his Watergate, Clinton his Monicagate, and the USDA has its HACCPgate. Organoleptic inspection, coupled with a major increase in microbial testing, has major advantages over HACCP's perverted non-inspection methodologies.
The natural tendency for all humans is to overestimate our ability to control the flow of truth. We also underestimate the ability of truth to be revealed in spite of our best attempts to cover it up. HACCP devotees have yet to perceive their impending Waterloo.
Today's headlines reveal that ISO (International Organization for Standardization) strongly recommends that traceability protocol be implemented globally. The day will come when our foreign trading partners will require American compliance.
The suggestion has been made to merge USDA and FDA responsibilities into one agency with overall authority. I respectfully disagree. If such a merger was done, and staffed with current USDA and FDA bureaucrats, no improvements would ensue. In order for such an agency to succeed, its primary goal must be the promotion of public health, not the protection of corporate profits. Both goals can be accomplished, but HACCP is not the engine required to drive the vehicle. Nor is current USDA leadership.
Until the USDA is willing to trace back to the slaughterhouse origin of E.coli, the incidence of E.coli recalls will increase. Since the agency has shown no interest in tracing back to the source, Marler Clark had best be hiring more employees. Mr. Clark, USDA has NO intention to put you out of business.
John W. Munsell
Manager, Foundation for Accountability in Regulatory Enforcement (FARE)
Miles City, MT
July 26, 2007
A friend just reminded me of one reason why HACCP has not been more successful in preventing outbreaks and recalls related to E.coli-adulterated meat. In the lack of such success, we have been sitting on an inevitable powder keg of E.coli outbreaks, which has patiently waited until 2007 to rear its ugly head, evidenced by the multitude of recalls we've witnessed although we have yet to exit July.
Previously, when a meat plant experienced an E.coli recall, USDA had traditionally implemented a followup microbial sampling protocol in which the agency conducted a subsequent 15 consecutive days of additional E.coli tests. The results helped determine if the recall was due to an isolated one-time incident, or it could have revealed recurring sanitation/production noncompliances at the affected facility. This testing protocol was worth its weight in gold.
On April 18, 2003, FSIS issued Notice # 11-03 in which it rescinded the 15-sample protocol. Since that time, the pertinent FSIS District Office has subjectively determined the number of subsequent samples to be taken, which could be as few as one. Why did the agency rescind this valuable policy? I can think of two answers to this question, although there may be numerous plant-specific answers.
In early 2002, the agency discovered 3 consecutive days of positive samples at one plant during its 15-sample protocol. Although presented irrefutable source evidence, a successful traceback was not implemented to the slaughterhouse origin of the 3 positives. Four months later, during followup testing at another establishment, the agency was again confronted with additional lab positives. According to statements and documentation from agency personnel at the two plants, the slaughterhouse origin of E.coli-adulterated meat was the same at both plants, that being plant # 969. The evidence resulted in the 19 million pound recall at ConAgra in Greeley, CO.
Had it not been for the 15-sample protocol, the true slaughterhouse origin of E.coli meat in these two plants would not have been detected. Furthermore, the 19 million pound recall would not have occurred, which would have saved both the agency and the company the historic embarrassment which transpired. Less than 12 months after the ConAgra recall, the 15-sample protocol was jettisoned.
News reports this week reveal that FSIS plans to implement a revised sampling protocol which will be utilized following a positive E.coli lab test. Depending on the volume of production at the impacted plant, the agency will conduct either 8 or 16 additional microbial tests within 120 days. While this is certainly a step in the right direction, its value does not approximate the benefits of the previous 15-sample protocol which had been accomplished in the next 15 production days.
Contemplate the lost opportunities FSIS wasted since its issuance of Notice 11-03. We can assume that one or more of the dozens of plants suffering recalls since Notice 11-03 indeed had ongoing problems with meat contaminated with enteric pathogens, which by definition emanate from within animals' intestines. Since the agency eliminated the 15-sample protocol, truly guilty plants were insulated from detection because of the relatively non-existent agency sampling. This is troublesome realizing that the agency had just accused these plants of having failures in their HACCP plans. Realizing that the agency forced the plants to perform HACCP reassessments and implement corrective actions to prevent recurrences, we must assume that those plants constituted potential threats to food safety, thereby meriting increased agency scrutiny. If the plants did not constitute a potential food safety hazard, FSIS would not have required the companies to institute corrective actions (one would think).
Notice 11-03 removed these plants, some of which were truly guilty of INTRODUCING E.coli, from the agency's E.coli radar. Coupled with the fact that FSIS has not been aggressively forcing tracebacks to the source, the truly noncompliant plants continued to produce and ship products into commerce, no longer subjected to any meaningful agency microbial testing methodology. The agency acted as though what we don't know won't hurt us. The multiple recalls in 2007 proved otherwise.
FSIS is to be commended for returning to a followup testing program, albeit a mere shadow of its previous protocol. The real value to the new policy will come when additional positives are detected. If the agency will follow those subsequent positives back to the slaughterhouse origin, public health and the entire industry will benefit but only if FSIS forces the ORIGINATING slaughterhouse sources to clean up their act. If FSIS continues to place all accountability on the downline further processing (mostly non-slaughter) plants, the potential value of this change will dissolve as quickly as the 15-sample protocol did.
Bottom line: the dozens of plants impacted by recalls since Notice 11-03 have received a decreased agency surveillance compared to what existed prior to the Notice's publication. We should not be surprised that E.coli, spared from effective corrective action AT THE SOURCE, have flourished in the interim and chose 2007 to reveal themselves because of FSIS unwillingness to test for them at "problem" plants.
A potential cause for concern: will the agency's new followup protocol only be implemented when agency-conducted testing reveals microbial positives? What will the agency do when company-conducted tests turn up positives? Will HACCP prevent FSIS from utilizing the followup protocol when the plants discover their own positives? A truly "science-based" meat inspection system should treat all positives alike, regardless of what entity performed the lab test. My concern is that FSIS, and the industry, will conclude that company-generated test results will be considered confidential and proprietary under the HACCP umbrella. Shielded from agency scrutiny, plants will then blithely continue operations "as is", and we will wonder why there are so many recalls in 2008.
John W. Munsell
Manager, Foundation for Accountability in Regulatory Enforcement (FARE)
Miles City, MT
July 28, 2007
How can I get in contact with John Munsell or the Foundation of Accountability in Regulatory Enforcement?