I am writing this in response to Dan Flynn’s raw milk article which appeared in Food Safety News on April 28.  Mr. Flynn’s article reported on raw milk legislation currently being considered in Georgia, Missouri and Iowa.

The article reports that Georgia’s proposed Raw Milk Dairy Act, not signed by Gov. Kemp, includes several requirements. One is a warning label on the raw milk packaging which must say: “Warning: This is a raw milk product that is not pasteurized and may increase the risk of foodborne illness.”

Missouri’s proposed House Bill 1977 would legalize selling “Grade A” retail raw milk and raw cream products made in Missouri at  grocery stores, restaurants, soda fountains, and similar establishments. The raw milk products would also be required to post and carry warning labels saying “WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that can cause serious illness in children, the elderly, and persons with weakened immune systems.“  

The article’s concluding statement is “Pasteurization has prevented millions of people from becoming ill.  Most public health professionals and health care providers consider pasteurization one of public health’s most effective food safety interventions ever.” So true!

Quoting from Mr. Flynn’s article, pasteurization is the process of quickly heating milk to a high enough temperature for a short time to kill illness-causing germs.  The process of heating milk qualifies as a Critical Control Point, the CCP in HACCP which USDA’s Food Safety Inspection Service requires in federally-inspected and state-inspected meat and poultry establishments. A CCP is defined as a point in food production where controls can be implemented which prevent, eliminate and reduce pathogens to a non-detectable level. Interventions such as full cooking and irradiation qualify as CCP’s. Other valuable interventions, such as temperature control, are Control Points but clearly do not qualify for Critical Control Points in  the absence of a kill, or lethality, step.  

By the way, the HA in HACCP represents Hazard Analysis. A thorough Hazard Analysis has extreme importance and value to all production lines, fully cooked or raw, even on non-food items.

This is precisely why USDA frequently issues educational warning missives to the public, reminding consumers to properly handle and fully cook raw products that have not been subjected to a Critical Control Point intervention prior to sale to the public. Candidly stated, the Critical Control Point step in raw food must be conducted by the end consumer, such as restaurants or in home kitchens, where a lethality step can be implemented.

From a public health standpoint, the focus is on the word “RAW,” requiring due diligence by the end user to safely prepare the raw food prior to consumption.  The same reasoning is utilized by the state legislatures in Georgia and Missouri, as stated in Mr. Flynn’s article about legalizing the sale of raw milk in those states.

My purpose is not to take a stand on allowing or disallowing the sale of raw milk.  I can purchase raw milk, but I do not. Rather, my purpose is to question whether other raw products, including vegetables, meat and poultry, etc. should carry a warning statement, similar to warning labels required on raw milk.  

Packages of ground beef in my home freezer all include labeling stating “SAFE HANDLING INSTRUCTIONS.“  In small print are found the following instructions:  This product was prepared from inspected and passed meat and/or poultry.  Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly.  For your protection, follow these safe handling instructions.  These instructions include warnings to COOK THOROUGHLY (my emphasis), keep food hot, and cold, and keep separated from other foods.

An important point: how can product inspected and passed [under HACCP inspection] possibly contain bacteria?  If raw meat has been produced under HACCP, the meat, by USDA mandate, cannot contain pathogens!

Mandated safe handling Instructions on raw ground beef constitute a tacit admission that USDA acknowledges food safety hazards exist in raw meat.  Such instructions should not be required, because the ground beef — and all raw meat and poultry — processed at FSIS-inspected plants have (1) Raw, Ground and/or (2) Raw, Not Ground HACCP Plans that allegedly have Critical Control Points to reduce pathogens to less-than-detectable levels. Since all raw meat and poultry emanating from FSIS-inspected establishments have ostensibly killed all harmful pathogens, there should be no need for subsequent safe handling labels.

It bears repeating that true, original, science-based HACCP was specifically designed to produce consistently safe food for the Army and NASA. Thus, true HACCP specifically denied the HACCP label for raw food, because raw food lacks a kill step, thus can easily harbor invisible pathogens. Astronaut food, and battle field rations are all ready-to-eat, and certainly not raw. But after the 1993 Jack in the Box hamburger outbreak, the USDA’s embarrassed Food Safety Inspection Service was desperate to introduce a new system which would guarantee the production of safe food. Voila, HACCP was the answer! FSIS intentionally mandated a bastardized version of pseudo HACCP, which included raw meat and poultry under the HACCP aegis, knowingly in the total absence of a valid, legitimate Critical Control Point.

Back to raw milk, the production of which likewise mandates valuable warning labeling for consumers.  Since raw milk must bear warning labels, a laudable safety step, should all raw foods display similar warning labels?  

Mr. Flynn’s article stated “From 1993 through 2012 (19 years) there were 127 outbreaks reported to CDC with links to raw milk. These outbreaks included 1,909 illnesses and 144 hospitalizations.”  These 1,909 illnesses are veritably unfortunate, causing untold heartache and pain to many families. I am surprised that the annual average was only 100, thinking the annual average to be much higher. I’d like to know the annual average of sicknesses attributed to consumption of other raw foods, such as leafy green vegetables, cantaloupe, eggs, sprouts, etc. In spite of the highly acclaimed, but unscientific, HACCP mandate for raw meat and poultry, the industry is not making progress to eliminate salmonella from raw foods. At some time, FSIS must realize that in the absence of a legitimate Critical Control Point kill step, Salmonella will continue to persist in raw food, spawning countless more sicknesses and recalls.

Because of this, shouldn’t all raw food be labeled with warning instructions?  If not, why are raw milk and ground beef singled out, and required to be properly labeled?

We need to remember that the end user must do his/her part in the preparation of consistently safe food for consumer use. Only when all food is subjected to a valid kill step prior to sale to the public, and sold “ready to eat,” will consumers be off the hook for their part in the food safety farm-to-fork continuum. This will never happen, as we all purchase raw foods such as ground beef, chicken breasts, turkey and lettuce, which we will prepare at home. Thus, end users must simply accept some responsibility to properly handle and fully cook raw products.

Lastly, we must admit that USDA’s Food Safety and Inspection Service will totally oppose my recommendations. Why?  Because their “version” of HACCP allegedly prevents, eliminates and reduces pathogens to a non-detectable level in raw meat. Thus, no need for warning labels on any raw meat produced under its HACCP protocol.

USDA’s implementation of its intentionally faulty HACCP protocol has lulled American consumers to sleep, de-incentivizing us from practicing safe handling practices.

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This is a followup on my response to Brianna Leach’s opinion essay published by Food Safety News on May 26. My initial response focused on HACCP. In order for Part Two to make sense, readers might consider reading Part One, entitled “Is contributing author HACCP trained?” published by Food Safety News on May 28.

The two legs upon which HACCP was designed were Prevention, and Corrective Actions.  If unsafe meat is produced, a plant must implement Corrective Actions to prevent future recurrences.  This is foundationally important!  How can microbial test results aid in Corrective Actions?

When FSIS mandated HACCP implementation by the meat and poultry industries, the agency justified the mandate by explaining the new system would be “science-based”.  A major component of “science” would entail required microbial sampling, both by the agency and the plants.

In Part One, I defined HACCP as a preventative system designed to control significant identified hazards by means of validated Process control measures.  Prior to selling my plant in 2005, my Slaughter hazard analysis contained fifteen Process Steps.  My Raw Ground hazard analysis contained seventeen Process Steps.  Thus, if my plant produced unsafe meat, which of these 32 Process Steps experienced failures?  How can a plant identify the Process Step(s) which were deficient?  The guilty culprit can be identified by validating each Process Control step in the plant’s production line.  Under True HACCP, plants validated each Process Step to prove the entire system qualified for HACCP.  Plants focused testing at those Process Steps most likely to contaminate food.  Testing finished product is fully incapable of identifying which Process(es) failed.

E.coli and Salmonella are “Enteric” bacteria, which is defined as “Of or within the intestine”.  When intestines empty themselves in the form of fecal manure, and the manure attaches to hides, we see that these bacteria will spread not only from perforated intestines, but also from manure-covered hides.  The primary origin of E.coli and Salmonella is the slaughter operation.  Granted, contamination can also occur from other origins, but its occurrence is insignificant.  Most further processing plants do not slaughter, nor do retail meat markets.  Neither entity has intestines or manure-covered hides on their premises.  Both entities purchase all their meat from outside source slaughter providers.  When meat is sampled from these entities, adverse test results would seem at first blush to indicate that the entity has a failure in its production line, intimating sanitation failures.  

USDA/FSIS refuses to acknowledge the GIGO (Garbage In, Garbage Out) effect in such situations.  Both of these entities rely entirely on the safety of meat purchased from their up line slaughter providers.  But, FSIS endorses assessing full liability against the downstream further processor.  As such, FSIS expects the downstream entities to (1) detect the presence of invisible pathogens in meat purchased from the outside, and (2) remove the invisible bugs.  Ironically, neither the source originating slaughter plant nor its FSIS inspectors were capable of accomplishing either (1) or (2), allowing the product to be shipped into commerce in containers proudly labeled “USDA Inspected and Passed”.  PASSED pathogens!

 Therefore, what kind of Corrective Actions can the downstream entities perform to prevent future recurrences of contaminated meat?  

Years ago, FSIS piously proclaimed that it preferred to perform sampling “As close to the consumer as possible”.  This preference may still exist today?  This statement portrays the agency as being a premiere pro-consumer food safety activist; conveniently ignoring that such testing is performed as far away from the source of contamination as possible.

Under HACCP, FSIS mandated a “Zero Tolerance” for fecal, ingesta, and milk.  Thus, the agency allegedly prohibits the existence of any E.coli in meat products.  More on this later.

Testing finished product, such as ground beef, circumvents the possibility of corrective actions since in many cases the true SOURCE of contamination is not identified, by intentional agency design, and which of the dozens of Process Steps was/were deficient.  Indeed, if finished product testing reveals the presence of pathogens, and consumers were notified, fewer sicknesses would occur.  But, what can be done to promote HACCP’s foundational Corrective Action mandate?  Reducing future recurrences is diplomatically ignored.  Dr. William Sperber, prominently mentioned in Part One, states “Nothing fails like finished-product testing to assure food safety.  It was the failure of conventional QA finished product testing in the 1960’s that did not detect Salmonella in many dried foods and ingredients that led to the current HACCP system in the food processing industry.”  

When FSIS introduced its version of HACCP in the 90’s, the agency explained that microbial sampling would be an integral and required part of this improved system, heretofore mostly ignored.  In fact, in my plant’s fifty-four years of operating prior to HACCP implementation, neither the agency nor the plant conducted any microbial sampling.  After HACCP’s implementation, both FSIS and my plant collected multiple dozens of samples for ongoing lab analysis.  As a result of agency sampling of my ground beef, I recalled 270 lbs of product in January, 2002.  In February, we experienced three consecutive days of lab positives, seemingly indicating my plant was filthy!  More of this later.

The largest plants implemented HACCP on or before January 26, 1998.   A mere six days later, on February first, FSIS issued Directive 10,010.1 which exempted some plants from agency-conducted sampling.  The Directive stated that plants which already do their own sampling, and had experienced zero positives in the previous six months, were exempted from FSIS sampling.  We will see how that exemption worked out.

During my recall in January, 2002, the FSIS inspector who collected the sample immediately declared that the meat ground had originated from another plant, NOT from my kill floor.  Thus, agency enforcement actions were quickly concluded.  Before releasing its recall to the media,  the FSIS recall committee called me to confirm I was willing to conduct a recall.  The committee was a multi-disciplinary group of ten agency veterans, top notch folks.  After agreeing to the recall, a committee member informed me that I must conduct a HACCP Reassessment, and implement corrective actions to prevent recurrences.  I asked the committee what corrective actions were available to me, realizing the meat was Coarse Ground Beef I had purchased from an outside slaughter provider.  I asked how I could force my suppliers to ship me strictly safe meat.  The committee’s reply was a veritable watershed moment for me.  They replied………nothing!  Bingo, my education had begun.  Now angry, I repeated the question, indignantly.  Finally, one of its members replied that I should obtain a copy of my supplier’s HACCP Plan.  Now what good would that have done?  But, this gathering of the best technicians the agency could gather had to provide me some kind of reply, however inane.

At the time, agency policy required the collection of fifteen additional samples.  In the midst of the fifteen, we experienced three consecutive days of lab positives, on February 19, 20 and 21.  Now however, we had copiously documented all related evidence regarding the source of the unsafe meat, and all our grinding protocol on every day.  Upon our review of grinding records, we discovered that the source of all three positives was plant # 969, ConAgra’s plant in Greeley, Colorado, all from one grinding lot on one production day.  A document hand-written and signed by the inspector and his veterinarian supervisor which referred to # 969 was featured in a subsequent NBC Nightly News segment.  How did the Minneapolis FSIS District Office respond to such smoking gun evidence?  The DO stated I had no proof that the unsafe meat did not originate from my own kill floor (why document anything?), shut down my grinder for four months, while allowing #969 to continue operations with no corrective actions.  

What happened after four months?  A similar conundrum occurred at a meat plant in Denver, again producing several positives after grinding meat from # 969.  No longer able to hide its head in the sand, FSIS intervened, and #969 conducted two recalls totaling 19.1 million pounds.  The agency then graciously allowed me to commence grinding again.

Smoking gun evidence from two plants, emanating from this 15-sample protocol would have been worth its weight in gold, had the agency responded in an ethical, scientific fashion.  Because the protocol was embarrassingly effective, FSIS had to do something.  So, it eliminated the 15-sample protocol!  The agency substituted a different protocol, including a dramatic reduction in the number of samples.  This change was announced in Notice 70-10, dated November 30, 2010.

This story is not about my plant, but about systemic attitude problems within FSIS which effectively insulate the large source plants from pathogen liability, while passing all liability downstream to victimized further processors.  Corrective actions were ignored at the Source.  Compared to original, True HACCP, FSIS sampling policies emasculated the food safety value of FSIS-style HACCP.  Similar problems have occurred all across America at small FSIS-inspected facilities.  

Following ConAgra’s 19.1 million lb recall, USDA’s OIG performed an investigation.  OIG’s findings included numerous scathing revelations, some of which were:

“USDA had reduced its oversight short of what was prudent and necessary for the protection of the consumer”

“Although animal feces on product was repeatedly observed during production at ConAgra, USDA took no enforcement action”

“From April 12, 2002 through October 21, 2002, OIG noted at least 115 E.coli positives at the ConAgra plant”

Likewise, an article in the local Greeley Tribune newspaper stated that in the 100 days prior to ConAgra’s recall, the plant had experienced 34 lab positives, in the absence of effective Corrective Actions.

How could ConAgra have qualified for the exemption required in Dir 10,010.1, requiring zero positives in the previous six months?  Also, plants were not required to share lab results with the agency, directly benefitting FSIS comfort.  If FSIS had been aware of results, the agency would have been required to step in and attempt some enforcement actions, which it was loathe to do.  The agency now has access to plant-conducted pathogen testing results.

And whatever happened to the agency’s “Zero Tolerance” mandate?  Well, the mandate only pertains to small plants, not to the industry’s hegemons.  Adding insult to injury were callous but truthful remarks made by then-USDA Under Secretary for FSIS, Elsa Murano.  In a July 25, 2002 article in the World-Herald Bureau, Murano was quoted as saying:

“Because Est. #969 slaughters 5,000 head of cattle and produces about 800,000 pounds of beef daily at the Greeley plant, one or several positive E.coli tests on some days wasn’t cause for alarm.  That is not that high a number”.

I might add that one positive test at a small plant results in aggressive FSIS enforcement actions.  As stated in Part One, FSIS-style HACCP has conveniently deregulated the large meat plants, while hyper-regulating small plants, forcing many out of business.  This is FSIS-style “science”.

When my plant experienced three consecutive days of adverse lab results, the broker who sold me the Coarse Ground Beef provided me a PR pamphlet produced by ConAgra.  The pamphlet explained the multiple hurdle intervention steps implemented by the plant, including some scientific work provided by Colorado State University.  It’s conclusion was that the wide portfolio of ConAgra’s interventions produced a “99.99999% (7-log) reduction in pathogens, virtually sterilizing carcasses”.  It’s subsequent 19.1 million lb recall reveals that science can sometimes be stranger than fiction.

FSIS had the authority, but lacked the will, to quickly change its sampling policies.  For example, on July 26, 2002, the agency’s Office of Field Operations sent an email to all District Offices stating:

:At the time the [ground beef] sample is taken, the IIC will obtain from the establishment, the name, point of contact, and phone number for the establishments supplying the source materials for the lot of ground beef being sampled.”

Unfortunately, this remarkable agency about face policy change was rescinded two months later.  An agency official stated at a public meeting that the agency rescinded it “For Legal Reasons”.

Three months later, a Senate Field Hearing was conducted in Billings, MT on December 11, 2002 to discuss these issues.  At the Hearing, I suggested that FSIS inspection personnel document all source evidence at the time of sample collection.  The Hearing moderator, Senator Conrad Burns, asked William Smith, then-FSIS Asst Administrator Office of Field Operations “Mr. Smith, do you want to respond to that?”  Mr. Smith replied “…..we could have inspectors doing more important things”.  Perhaps food safety is not important?  Nor are meaningful Corrective Actions.  Mr. Smith also stated “…..a number of packers would also be very upset about us collecting information on negative findings”.  Mr. Smith was unusually candid, because the largest packers would indeed be upset if inspectors would document the origin of meat being sampled, imperiling large source slaughter plants.  

As previously stated, FSIS policies did not permit inspectors to document the origin of sampled meat at the time of sample collection.  A full eight years later, on October 8, 2010, FSIS issued Notice 58-10 which mandated source documentation when agency inspectors collected meat samples for lab analysis.  The next year, on August 3, 2011, Ag Secretary Tom Vilsack directed FSIS to announce, in 90 days, the first step in transforming the agency’s traceback policy.  One year later, as related in Helena Bottemiller’s article in Food Safety News dated May 3, 2012, Under Sec for Food Safety Dr. Elisabeth Hagen said that FSIS would soon begin tracing meat contaminated with E.coli O157:H7 back to the source before illnesses are linked to the product and in some cases even before test results are confirmed positive.  Dr. Hagen stated that FSIS would “move quickly to identify the supplier of the product”, and then if the test is confirmed positive, notify any processors who received contaminated beef from the implicated supplier to recall product.  Helena Bottemiller also stated that at the time, FSIS did not conduct a traceback investigation unless there were illnesses linked to the product. Yet two years later, on August 14, 2014, Dan Flynn’s article in Food Safety News stated  “On August 13, USDA announced that FSIS is adopting new procedures to trace contaminated ground beef back to the source more quickly.  One tool will be grinder logs that small retail meat shops will now have to maintain.”  Ironic that a full twelve – fifteen years after the industry implemented HACCP, only then did FSIS begin developing traceback policies.  Without irrefragable source evidence, the industry cannot implement meaningful corrective actions, a truism lost on FSIS.

After we had sent a ground beef sample to an outside lab years ago, the lab subsequently called me to state that the sample was potentially positive, and did I want the lab to continue the test to determine if the sample was confirmed positive.  I was incredulous.  The lab rep explained that if we terminated the lab’s testing of that sample, we would be able to state that we had not experienced a confirmed positive.  I then asked what was the value of microbial sampling if I prematurely terminated lab findings?  He merely responded that plants have the right to stop additional lab tests.  I instructed him to finish the test, which fortunately resulted in a confirmed negative.

So when Brianna Leach referred to microbial sampling of product, she needs to be fully aware of FSIS-style sampling protocol which reduces the ability to determine the true source of contamination.  Plus, she and all consumers deserve to understand lab protocol.

In conclusion, microbial lab results can be useful in promoting food safety and public health, if they allow a scientific identification of the source of contamination.  Until FSIS develops the courage to force the source plants to implement meaningful corrective actions, the production of unsafe products will continue, and consumers will be sickened.  Meaningful corrective action steps are short-circuited by the lack of efficacious critical control points (CCP’s) for raw meat and poultry.

Standing behind the skirt of true HACCP, FSIS has lulled consumers to sleep.  Explaining that the agency adheres to a “Zero Tolerance” mandate for E.coli, ostensibly possible because of HACCP’s advent, consumers perceive that all raw meat and poultry should be safe to consume.  When the meat industry, as well as USDA suggest that consumers are responsible to cook raw meat to kill any resident bacteria, consumers and consumer organizations howl and accuse the industry of shirking its responsibility.  It is necessary to admit, although embarrassing to FSIS, that all raw meat and poultry carries inherent risk, because it has not been subjected to a legitimate CCP kill step.  How can that be?  Frankly, because FSIS-style HACCP is not true HACCP, which as I previously stated was established for products intended to be ready-to-eat.  As I stated in Part One, the top agency official in 1995 admitted that FSIS had changed HACCP.  The problem is not with the meat industry!  The primary culprit here is FSIS, which falsely portrayed its version of HACCP as being capable of producing consistently safe raw meat and poultry because of HACCP.  My hope is that this Part Two clearly elucidates for everyone multiple problems inherent with FSIS-style HACCP — for raw products. 

The primary proteins my wife and I purchase are raw ground beef and boneless chicken breasts, both high risk products.  But we treat both items as highly lethal, because they are!  The mere fact that both products have carried the official USDA Mark of Inspection means nothing to us.  We accept the reality that the only means available for us to consume safe meat and poultry is to accept rigorous cooking and handling protocol in our kitchen.  

Perhaps two years ago, Seattle food safety attorney Bill Marler authored a blog article in which he complimented the meat industry for its progress in producing safe meat.  Marler stated that when he got his start defending consumers who had been sickened in the Jack In The Box outbreak, his primary workload was litigation against meat plants. In his relatively recent article, Marler admitted that his business had very few cases involving meat plants.  The meat industry has indeed made substantial progress in its goal of producing safe meat, while yet acknowledging the futility of producing consistently safe raw meat and poultry in the absence of valid Critical Control Points such as full cooking and irradiation.  

Thus, we can deduce that HACCP’s implementation in the meat and poultry industry has resulted in safer food.  Would the industry have unilaterally implemented these changes without the FSIS mandate?  No.  The fact still remains that raw meat and poultry does not qualify for true HACCP, in the absence of a legitimate CCP.  So when contaminated meat is produced, FSIS cannot in good conscience claim the affected plant has a failure in its HACCP Plan in the total absence of a kill step.  This awkward conundrum spells trouble for FSIS, which has an insatiable appetite for pointing fingers at allegedly insanitary plants.  Typically, these downstream further processing plants are but innocent victims which unwittingly and legally purchased source meat from upline suppliers, meat laced with invisible pathogens.  Coupled with the agency’s historical ambivalence towards tracing back to the source of contamination, American consumers need to handle and cook raw meat and poultry with the greatest of caution.

The December 2009/January 2010 edition of Food Safety Magazine included an insightful article authored by afore-mentioned microbiologist Dr. William Sperber and Richard Stier.  The article was entitled “Happy 50th Birthday to HACCP”.  The article’s concluding statements were as erudite now as they were back then, and provide a fitting capstone to this Part Two. The statements were:

“Whatever the ultimate configuration of HACCP system details, it is comforting to note that the HACCP pioneers, beginning 50 years ago, established features of HACCP that have not changed.”

The authors then identified three features, one of which was:

“It [HACCP] does not rely on product testing or lot acceptance criteria”, and “These features are the timeless essence of HACCP, serving as a permanent testament to the vision of the HACCP pioneers”.

FSIS-style HACCP, lacking consistent scientific integrity, has given true HACCP a blemished reputation, while misleading consumers.

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Editor’s note: We want to hear from our readers. Letters to the Editor can be submitted via the Contact Us link on our website.

Dear Editor,

I am responding to Brianna Leach’s article released by Food Safety News on May 26. She includes comments on the USDA’s implementation of its HACCP rule in 1995. For those who are unfamiliar with the term HACCP, it means Hazard Analysis Critical Control Point. What does that mean?  The HA in HACCP stands for Hazard Analysis, and the CCP in HACCP stands for Critical Control Point, a dynamic duo.  Each plant must initially perform a hazard analysis of their specific operations:  slaughter plants have hazards dramatically different than a jerky plant.  

HACCP is a preventative system designed to control significant identified hazards by means of validated process control measures. One way to “validate” process control measures, also known as “interventions”, is via microbial testing for pathogens.  

What is meant by the term “Critical Control Point”, aka as CCP?  A CCP is a point in the production process where controls can be utilized to Prevent, Eliminate, or Reduce (PER) pathogens to a less-than-detectable level. Thus, CCP’s such as cooking or irradiation will PER pathogens, thus qualifying the product and its production line for HACCP designation. Products such as fully-cooked hams, jerky and beef sticks conform to true HACCP requirements.

HACCP was developed by the Pillsbury Company in the 60’s in a joint effort with NASA and the Dept of Defense, both of which required consistently safe food for soldiers on the front line, and for astronauts in outer space. HACCP is science-based, in stark contrast with the USDA’s traditional inspection system which utilized an organoleptic inspection which relied upon sensory inspection of carcasses and finished product, utilizing visual, smell, and touching senses to detect unsafe meat.  The Jack in the Box outbreak caused by E.coli O157:H7, an invisible pathogen, revealed that pathogens cannot be detected organoleptically. Embarrassed by the JITB outbreak, USDA eagerly embraced the HACCP concept, and required all federally inspected plants to implement HACCP in a staggered order:  the largest plants (500+ employees) had an implementation deadline of January 26, 1998.  Small plants a year later, and very small plants another year later.

As long as USDA’s version of HACCP complied with true science, and remained true to Pillsbury’s initial scientific protocol, HACCP would be a remarkable addition to the agency’s reason for existence in the industry, promising safer meat.  Herein lies the rub.

USDA/FSIS required all meat plants to write their own customized HACCP Plans, specific to their unique operations. Plants producing Ready-To-Eat Jerky would have HACCP Plans dramatically different than plants producing raw ground beef. Nevertheless, all FSIS-inspected plants, regardless of their product line, were required to implement HACCP utilizing various HACCP categories.  In this example, plants producing raw ground beef must have a HACCP Plan called a “Raw, Ground HACCP Plan”. RTE jerky would require a plan with titles such as “Ready-To-Eat, Shelf Stable HACCP Plan”.  

Please remember that a Critical Control Point must utilize interventions to Prevent, Eliminate or Reduce pathogens to a less-than-detectable level. Let’s be honest here! Raw Meat & Poultry will never be consistently safe unless it is subjected to a “Valid” intervention, such as irradiation and full cooking. Which is precisely why NASA and the Dept of Defense require consistently safe products which had been subjected to what is called a “Kill Step,” such as full cooking or irradiation.  

Pillsbury developed HACCP specifically for products subjected to a Kill Step.  FSIS changed HACCP, requiring even raw meat & poultry to have HACCP Plans, full well knowing in advance that production of raw meat & poultry lacks a kill step. Thus, raw meat and poultry lacks a valid CCP.  Any HACCP Plan without a legitimate CCP is not HACCP! FSIS was fully cognizant of this fact, but still chose to require all meat plants to implement its bastardized version of HACCP.  

Prior to FSIS implementation of its HACCP rule, the agency relied heavily on its prestigious National Advisory Council on Microbiological Criteria for Food (NACMCF) for scientific input, ensuring that the agency’s HACCP Rule would be scientifically valid.  At least two members of the NACMCF vigorously opposed certain aspects of the agency’s rule as non-scientific.  They were microbiologists Gary Acuff and William Sperber.  Acuff is the Director of the Center for Food Safety and Professor of Microbiology within the Department of Animal Science at Texas A&M. A member of the NACMCF from 1992 – 1997, Acuff is currently a member of FDA’s Food Advisory Committee.  Sperber was and remains an international expert on HACCP, as he worked for Pillsbury from 1972 – 1995, helping refine true HACCP.  His unquestioned reputation is exemplified by the fact he served on the NACMCF for five terms.  No one on this globe was more closely familiar with true HACCP, for over two decades, than Sperber, who is now retired.  In his career, he worked for three major food companies: Best Foods, Pillsbury, and Cargill.  In 2000, he was appointed to the FAO/WHO roster of experts for microbiological risk assessments.  

Another point of major contention for some NACMCF members was FSIS’ misguided protocol for microbial testing on finished products.  My comments will focus merely on the agency’s abuse of true HACCP protocol.

Nevertheless, FSIS ignored scientific input from some members of the NACMCF, blindly forging ahead in its promotion of its faulty HACCP protocol. When questioned by Sperber, then-FSIS Administrator Tom Billy replied “We’ve changed HACCP, and there’s nothing you can do about it”. Rare candor! It also set the stage for future outbreaks emanating from raw meat & poultry, which was somehow produced without a kill step.  How could FSIS implement enforcement actions against raw meat & poultry plants which had alleged “failures” in their HACCP Plans? This awkward scenario was the result of the agency allowing such plants to author HACCP Plans which included CCP’s which the agency was fully cognizant of not complying with PER requirements. Welcome to FSIS-style HACCP!

More recently, FSIS has found a solution to this conundrum, changing the definition of a CCP.  In addition to the original requirements to Prevent, Eliminate or Reduce (PER) pathogens to a less-than-detectable level, the agency has conveniently added the term “Control.” An example would be temperature control.  Maintaining low temperatures will indeed control the environment, denying pathogens the opportunity to explode in numbers, merely by ensuring low temps. While temperature control is an immensely important tool in the plant’s portfolio of interventions, it is woefully inadequate and fully incapable of Preventing, Eliminating and Reducing pathogens! Folks, this is not science.

After I sold my plant in 2005, I established a foundation based on (1) representing the interests of legitimate small plants in their dealings with FSIS, and (2) communicating ideas to FSIS for common sense policy changes. During this time, I received numerous unsolicited communications from total strangers across America, including not only plant owners, but also disenchanted FSIS field personnel. They all related the same story, namely, FSIS intentional mistreatment of small plants.  Most criticism was centered on constantly changing agency HACCP requirements, not based in science, but on subjective, ephemeral personal opinions mandated by District Office (DO) personnel. In many cases, FSIS officials (CSO’s, EIAO’s, Compliance Officers and a plethora of DO HACCP technicians) were engaged in turf battles, all vying for ultimate authority while targeting small plants. One such official would visit a plant and mandate HACCP Plan changes, cautioning that failure to do so would guarantee a noncompliance report (NR), sometimes resulting in a Notice of Intended Enforcement (NOIE). Plant management dutifully make all mandated changes. Subsequently, yet another agency “expert” would arrive at the plant, and mandate that the recent changes be reversed, while mandating a new set of requirements, contradicting demands made by the previous agency expert. Unfortunately, this well describes FSIS style HACCP.

Exacerbating this dilemma is the fact that when a plant owner justifiably disagrees with inane requirements from the newest FSIS, the agency “rewards” the plant with a Food Safety Assessment (FSA), the results of which are guaranteed to harass the plant with subjective and frequently non-scientific mandates. Like the IRS auditor arriving at a business, stating “I’m from the IRS, and am here to help you.”

When FSIS targeted my plant in 2002, I had frequent communications with Rosemary Mucklow, executive director at the National Meat Association (NMA). A frequent topic we discussed was my ability to appeal agency decisions, including NOIE’s, and withdrawal of inspection personnel. Rosemary reminded me that during my appeal, my “lights would be out”. Rather than close my doors for an extended period, I acquiesced to agency demands merely to stay alive.

FSIS has free rein at small plants, knowing that such plants lack the deep pockets required to engage the agency with costly litigation, while lacking political clout. Thus, the agency plays with small plants like a cat plays with a captured mouse, enjoying the opportunity to abuse its power. In stark contrast, FSIS is paralyzed with fear of litigation emanating from the largest plants and their national organizations.  

The hypocrisy of this entire FSIS HACCP imposter is brought to light when we remember what HACCP and industry experts stated in official HACCP training sessions in 1996 and thereafter. I attended such sessions in Salt Lake City in February 1996 and again in Kansas City in March 1996, each time taking different employees for training. The primary speakers were from academia, all familiar with the HACCP concept. Interesting that at both sessions, a FSIS spokesman also gave a presentation describing the agency’s role under the HACCP rule. I well remember four statements from the FSIS representatives, who stated that under the HACCP rule, FSIS’ role would be:

1.  FSIS would no longer police the industry, but the industry must police itself.

2.  FSIS would jettison its previous command and control authority.

3.  Each plant must author its own HACCP Plan(s), reflecting on the unique conditions at each plant.  And, FSIS had no authority to tell a plant what must be in its HACCP Plans.

4.  FSIS would implement a “Hands Off” role at meat plants. 

All plant owners were incredulous at these agency publicly-revealed promises, ostensibly showing the agency’s desire to embrace deregulation. Only time would reveal the agency’s willingness to comply with any of their four promises.

Since 2000, when very small plants introduced HACCP, history has proven time and again that FSIS has aggressively  deep sixed all four promises above, at least at small plants. To argue otherwise would be sticking one’s head in the sand. FSIS forbids plants to engage in “Bait and Switch” marketing tactics.  Yet, FSIS has successfully baited the industry with its four public promises above in order to obtain industry “voluntary” compliance with FSIS-style HACCP, and then switched the agency’s operations back to its pre-HACCP authority. Few people grasp the agency’s deliberate misdeeds here.

Conversely, my contacts within the industry, and especially with FSIS personnel (many of whom are now retired) consistently state that for the most part, the agency has complied, to varying degrees, with all four promises with the largest packers. These transnational behemoths cannot be treated like the mouse by the cat, but constitute veritable powerhouses, not to be toyed with. I don’t criticize them for this.  Each large plant has invested considerable time and money over the years to attain the level they now enjoy.  The safety of their product has indeed improved since the JITB outbreak. They are sincerely committed to food safety, as failure to do otherwise would sicken and/or kill their own customers. My perception is that Brianna Leach has improperly portrayed the industry as being focused exclusively on profits.  I respectfully disagree.  

Another major failure in the FSIS bastardized version of HACCP is its microbial sampling protocol, which artificially targets its enforcement actions against downstream further processing plants, while insulating the large source packers from meaningful enforcement actions and agency monitoring oversight, and thus, for product liability. I will address this issue in subsequent comments. I doubt that Brianna Leach is personally familiar with problems inherent in the agency’s faulty sampling protocol.  She and Food Safety News readers need to know, as Paul Harvey used to say, “The Rest of the Story.”

— John Munsell

About the author: John Munsell ran a USDA-inspected meat plant for 34 years, which had been in the family for 59 years. Raised in Miles City, Montana and educated at Montana State University in Bozeman, MT, John returned to the family business subsequent to employment at Continental Oil and Target Stores. Having sold the business in 2005, John subsequently opened a deli/bakery at a local retail grocery store, and is currently employed by Miles Community College as a Biofuels/Renewable Energy Coordinator.

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At the time FSIS required all federal plants to implement HACCP, our family-owned slaughter/processing plant had been in existence for 49 years, 24 years of which I had been the manager. Thus, I realized that if we were to continue to exist, that our entire staff would need to be fully on board the HACCP Express. So, I took three other employees to official HACCP training sessions in Salt Lake City in February 1996 and Kansas City in March 1996. Out of eleven full-time employees, four of us were HACCP-certified. We created HACCP Plans for Slaughter, Raw Not Ground, and Raw Ground.  We were prepared. We were also indoctrinated in FSIS-style HACCP.

Trainers explained that a Critical Control Point (CCP) was a point in the production process whereby controls could be implemented to Prevent, Eliminate, or Reduce (PER) pathogens to a less-than-detectable level. We learned how to produce a thorough Hazard Analysis for every point in our production process. We were then provided a “Decision Tree” to be used to identify the areas in the production process which would be most advantageous to utilize CCP’s .  

Each step in our HACCP Plan required a Hazard Analysis. Once the Analysis was performed, we had to ask ourselves if available interventions to utilize against the hazards would qualify for a CCP. If not, the Decision Tree required that we forward the Hazard(s) to the next production step, where we again used the Decision Tree to determine if an intervention could be listed as a CCP at that step, meeting PER requirements. Once we listed a CCP at one point, danger from the hazard (E.coli, Salmonella, etc) was theoretically removed from the product flow. Thus, we might not have to address the hazard(s) again in subsequent production steps.  

All attendees at the session, who were authoring Raw HACCP Plans, were greatly puzzled how we could truthfully utilize the Decision Tree, because we knew that no interventions qualified for a true CCP, because they failed in meeting PER requirements. But we had also been told that FSIS would not allow us to write a HACCP Plan without at least one CCP. The PhD academicians who conducted the training sessions repeatedly reminded us that HACCP was “science based.” Thus, the Decision Tree forced us to identify plausible, valuable interventions at one or more points in the production process, even though they didn’t meet HACCP’s PER definition of a CCP. We were malleable in the hands of FSIS and the presenters, and did what we were instructed.

So, we all agreed amongst ourselves, with the full endorsement of the training presenters, that we simply had to choose one or more steps in which we would declare a CCP, full well knowing that the interventions were merely a control measure, not a CCP. If we refused to use CCP’s in Raw Plans, FSIS would not accept the Plan.  It was a Catch 22 conundrum. It was at this point a cognizant dissonance occurred.  

My focus was to create picture-perfect HACCP Plans, including questionable (albeit inadequate) CCP’s for my plant, which would withstand review from any agency official who would subsequently walk through my door. Thus, I initially created numerous CCP’s for our three HACCP Plans, to comply with “Decision Tree” requirements. After we implemented HACCP in 2000, numerous FSIS supervisors strongly suggested, to my surprise, that  I should greatly reduce the number of CCP’s in my three Raw HACCP Plans. They explained that the numerous CCP’s were an unnecessary overkill, which would only create additional and time-consuming paper chase requirements for my staff, and for agency reviewers. They were correct!

Within a year after implementing HACCP, following many meetings with FSIS inspection personnel regarding HACCP-related decisions, we were all flummoxed by this HACCP ordeal. 

We realized that something wasn’t right with FSIS-style HACCP, and our HACCP Plans, but couldn’t quite put our finger on it. Every time a new FSIS official appeared at our plant, typically a CSO, EIAO, or District Office big wig, it was suggested (aka “required”) to implement changes in our HACCP Plans. These changes would later be overruled/replaced by other agency employees who subsequently demanded we delete or change HACCP decisions required by previous FSIS field personnel. Failure to comply with this latest demand would automatically result in a NR or NOIE. None of us in the industry, or agency employees, dared suggest that FSIS-style HACCP was indeed not based on true science.  Why rock the boat, which might endanger our business or agency careers? 

We all came to realize we were living a lie, but couldn’t clearly delineate the lie. While FSIS HACCP decisions were frequently nonsensical, we nevertheless were unable to clearly reconcile this conundrum of pseudo-science agency demands. While FSIS and academia fully endorsed agency-style HACCP, we knew FSIS-style HACCP had inherent shortcomings, but we simply couldn’t explain why.  Mental malaise set in for FSIS field personnel and company management.

Someone then provided me an article written by William Sperber, providing the first step for us to wrap our minds around the questionable foundations of FSIS-style HACCP. Sperber was an eminently qualified microbiologist. He had worked for Pillsbury from 1972-1995, helping to refine and improve initial HACCP protocol that Pillsbury had invented a decade earlier. He later became a global food safety expert for Cargill. Sperber had also been a member of the agency’s prestigious National Advisory Council on Microbiological Criteria for Food (NACMCF), serving five terms on the Council. Another well-known Council member was microbiologist Gary Acuff from Texas A & M, who has been hired numerous times by FSIS to train agency individuals such as EIAO’s. Thus, FSIS acknowledges that both men were incredibly talented and qualified.

NACMCF was tasked with providing advice to FSIS to help the agency author science-based HACCP requirements for the industry. During Council meetings, Sperber and Acuff expressed their opposition to many aspects of FSIS-style HACCP ideals, many centered on the inability for RAW products to have legitimate CCP’s. Their voices were ignored. Acuff resigned from NACMCF, while Sperber held out for several more years.

In the mid-90’s, FSIS quietly discontinued hosting NACMCF meetings. Thus, Sperber personally asked then-FSIS Administrator Tom Billy why no meetings were being held. Billy responded that the agency had already made its decisions on HACCP requirements, and did not want any more public input. Billy also told Sperber “We’ve changed HACCP, and there’s nothing you can do about it.” Rare agency candor indeed.

Sperber wrote several articles on the subject, detailing numerous other areas in which FSIS-style HACCP was not true HACCP, and was not science-based. He stated that true, original HACCP did not include end product testing, but did require substantial initial testing at numerous points in the production process, also known as “Process Control.” If a finished product tests positive for E.coli O157:H7, the results do not reveal which of the numerous steps in the process was/were out of control.  Testing at a grinding plant does not identify the slaughter plant of pathogen origination. True HACCP required process control at each step of the production line, not simply at the point when the finished product became available. Sperber also stated that true, original HACCP did not require distinction of lots. Also, while temperature control is indeed an important control factor, it utterly fails the test to be named a CCP, although FSIS frequently suggests to plants that they name temperature control as a CCP because nothing else remotely plausible exists.

Sperber’s articles also defined the minimal control that government should have over plants which utilize HACCP protocol based in TRUE science. Such plants utilize a lethality/kill step, such as full cooking or irradiation, both of which are absent in raw products. Indeed, ready-to-eat products should always be safe to eat, having been exposed to a lethality step. Such plants qualify for deregulation. In stark contrast, raw products have not been exposed to lethality steps. Plants producing raw products thus qualify for much closer government oversight/regulation.

When FSIS originally described to industry players the agency’s revised role under HACCP in 1996, the agency publicly made the following four promises to the industry:

(1) Under HACCP, the agency would no longer police the industry, but the industry must police itself.

(2) The agency’s role under HACCP would be “hands off.”

(3) The agency would disband its previous command and control authority.

(4) Each business has the right to author its own customized HACCP plans, designed to reflect unique conditions which exist at the plant. And, FSIS would not have the right to demand what must be in HACCP Plans.

After HACCP was implemented by plants of all sizes, the agency has been grossly non-compliant with all four of their pre-HACCP promises, especially at small plants. History has shown time and again that after HACCP was implemented industry-wide, FSIS has unquestionably hyper-regulated the industry of small plants, which lack political influence or deep pockets to challenge intentionally faulty agency decisions. My favorite term for agency treatment of small plants is “hagride,” a verb meaning to torment and harass, especially with worry and dread. When “science” doesn’t work, rely on enforcement threats!

After reading Sperber’s articles, I’ve observed how the agency/academia HACCP tag team continues to discredit true science and original HACCP. As an example, after Jack In The Box experienced a 1993 outbreak from E.coli O157:H7-contaminated ground beef, the company formed a new food safety team. One industry magazine published an article about a requirement instituted by David Theno, a well-known, nationally-respected, and eminently qualified  member of the new JITB team. The requirement was that any plant supplying patties to JITB must test one patty every 15 minutes. This requirement would certainly discourage any grinder that knew it had ongoing pathogen issues, while rewarding plants with high food safety standards. After being familiar with Sperber’s articles, I was dismayed with the industry and agency plaudits for this policy. While this policy places more responsibility on the originating grinder, the increased testing regimen still fails miserably in being a valid CCP.  

Armed with these facts, the agency’s repetitious claim that the detection of pathogens is proof of a failure in a plant’s raw HACCP plan is disingenuous and specious. In stark contrast, the detection of pathogens in ready-to-eat products does indeed show a failure in that RTE HACCP plan. USDA/FSIS and public health officials have always cautioned consumers to properly handle and fully cook all raw foods, because such foods can be lethal. No one questions this undeniable fact. We will always find a certain incidence of pathogens in raw foods. Thus, how can the detection of pathogens in raw foods constitute a failure, when no legitimate CCP was ever in existence? While all meat plants share the goal of pathogen-free food, zero tolerance will only be accomplished via full cooking or irradiation, which by definition will not be found in raw products.

Quite candidly, any HACCP plan without a true, legitimate CCP is not HACCP.

Public health benefits greatly by the ability to identify the source of contaminated food, a goal aided by the development of PulseNet and improved sampling protocol. In spite of this, FSIS ardently avoided tracebacks to the origin of contamination the first decade of this century. During this time frame, FSIS’ Office of Field Operations (OFO) did not allow inspectors who collected ground beef samples for lab analysis to document source information on the meat being sampled. Under great pressure, FSIS finally relented, and published notices 58-10 and 06-13, frequently enabling a scientific identification of, and trace back to the true origin of contamination. Previously, OFO blithely placed all liability for contaminated meat against the destination plant which had innocently purchased meat already laced with invisible pathogens. During this unfortunate time in OFO history, public health and food safety suffered because OFO lacked the courage to implement enforcement actions at the true origin of contamination. So much for science.  

Perhaps only in the past four years have audacious industry folks publicly commented on the obvious shortcomings in FSIS-style HACCP. Such brave folks are likened to archaic dinosaurs from the previous “poke and sniff,” organoleptically-dependent inspection system which lacked the capability to detect invisible bacteria such as E.coli O157:H7 and Salmonella. Such folks are depicted as being opposed to updated, modern science. What FSIS fails to acknowledge is that science does not change. Rather, our understanding and application of true science improves. Water will always be H2O, will never be H3O, in spite of FSIS’ ongoing claim that “science changes.” Whenever FSIS relies on science fiction and/or political science, public health suffers.

Especially in a democracy, the best treatment for deceit and sickness is sunlight — and free speech.  FSIS assiduously avoids both. FSIS-style HACCP needs a midstream checkup if our top priorities are indeed food safety and public health.

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Prior to Murano’s arrival at FSIS, every USDA-inspected plant was required to develop and implement HACCP plans (Hazard Analysis and Critical Control Point plans). When FSIS introduced HACCP to the industry, the agency publicly proclaimed that HACCP plants would be authorized to police themselves, and that the agency would no longer have authority to police those plants. FSIS officials also publicly stated that FSIS would no longer utilize its previous “hands-on” authority, but would be limited to a “hands-off” role. The agency also publicly stated that under HACCP, the FSIS would no longer have command and control authority over plants.

Finally, the agency also publicly declared that it would not have the authority to tell plants what must be in their HACCP plans. What does this have to do with Murano?

In a “Frontline” segment on TV entitled “Modern Meat” on April 18, 2002, Murano stated, and I quote: “The HACCP system does not give the plants any authority. Responsibility. The authority is ours (FSIS). We are the ones with authority. We shut down plants all the time.”

FSIS, and Murano, thus legalized bait and switch, a practice the industry is not allowed to use. Would we allow Murano to do the same as Secretary of Ag?

These facts reveal that FSIS has intentionally implemented HACCP in a fashion totally noncompliant with the agency’s pre-HACCP promises, deceit which Murano embraced. This turn of events also reveals systemic problems within FSIS-style HACCP, which is a topic all its own.

Food Safety News readers may be familiar with FSIS behavior at my plant in 2002 after a ground beef sample there tested positive for E.coli O157:H7. Although inspectors at my plant notified agency officials that the bad meat at my plant originated from Establishment #969 in Greeley, CO, the FSIS shut down my grinder for four months, while making no demands for corrective actions at Est. #969. Four months later, in June and July 2002, Est. #969 announced a 19.1 million-pound recall for meat potentially contaminated with E.coli O157:H7. I then went public, detailing all FSIS misbehavior with this incident.

The story was reported by “NBC Nightly News” with Tom Brokaw on Aug. 1, 2002. When Murano was interviewed by NBC, she stated that when agency officials went to Establishment #969, they could not find any of the implicated meat with a production date of Aug. 29, 2001.

Well, duh, all product from Aug. 29 had already been shipped into commerce, some to my plant.

When FSIS was fully cognizant that Coarse Ground Beef produced on Aug. 29 tested consistently positive for E.coli, the agency should have suggested a recall of that date’s production. Instead, since FSIS couldn’t find any product produced on Aug. 29 at Est. #969, a full six months after production, agency investigators went home happy, and Est. #969 went on with business.

The FSIS, under Murano’s leadership, stuck its head in the sand, hoping for better days. Another outbreak, four months later, and the 19.1 million-pound recall forced FSIS to unwillingly extricate its head.

Subsequent to the 19.1 million-pound recall, FSIS conducted a thorough investigation of Est. #969. Only then did the agency discover that in the 100 days preceding the recall, the plant’s own internal testing revealed 34 days of E. coli positives, in the absence of any effective corrective actions.

On July 25, 2002, Jake Thompson wrote an article quoting Murano in the World-Herald Bureau regarding unsafe meat produced at Est. #969.  The article stated “Because Est. #969 slaughters 5,000 head of cattle and produces about 800,000 pounds of beef daily at the Greeley plant, one or several positive E.coli tests on some days wasn’t cause for alarm.” Murano further went on to state “That is not that high a number.”

Thus, Murano publicly stated that several positive E.coli tests on some days at large plants was acceptable to the agency.

Try to use that excuse on families which have lost a member due to E.coli O157:H7. Perhaps only a handful of E.coli deaths annually is “not that high a number?”

Do we want myopia to run USDA?

When a small plant like mine experiences but one positive test sample — even when the meat originated from another source slaughter supplier according to agency inspectors — FSIS removes the small plant’s ability to grind for several months. But when several positive tests occur daily at a large plant, FSIS yawns. That qualifies as Ho Hum.

Do we want someone to head USDA who is biased against small plants, and food safety, while immunizing large plants from accountability? Although only 7 percent of all meat plants are large, they produce 90 percent of our meat, according to FSIS’ Daniel Engeljohn. I suggest we need a Secretary of USDA who will fairly treat the other 93 percent of plants, whose minuscule size is considered a sin by FSIS.minuscule

It is worth noting that since HACCP’s inception, FSIS has assiduously promoted its daunting Zero Tolerance policy for E.coli O157:H7. Except of course, when the pathogen is detected at large plants.

The September 2002 edition of Meat Marketing & Technology stated “In July, Elsa Murano told an industry gathering she does not believe current food safety technology can guarantee pathogen-free meat.” Murano was quoted as saying “Zero risk is just not possible in a raw meat product.”

One can conclude that Murano insulates the largest packers from pathogen accountability because of this impossibility, making a mockery of the agency’s Zero Tolerance policy, while requiring small, downstream processing plants to fully meet the agency’s zero tolerance mandates.

Again, do we want this subjective and prejudiced mind set heading the United States Department of Agriculture?

Then-Montana Sen. Conrad Burns confronted then-USDA Secretary Ann Veneman about FSIS misbehavior at my plant. Veneman replied “We (FSIS) mishandled that from day one.” The fact that the USDA secretary was cognizant of agency misconduct at my plant leads one to believe that the head of FSIS at the time, Murano, was likewise cognizant. Nevertheless, Murano failed to intervene. She did not to require the source of pathogen-laden meat to be accountable, nor did she require corrective actions to prevent recurrences at the source.

Did Murano pressure FSIS into dismantling its unachievable goal of zero tolerance for E.coli in raw meat? No, although she publicly admitted that it was impossible. Is this leadership? Murano is precisely correct that zero tolerance is unachievable in raw meat, but did she pressure FSIS to change its foolish stance? No.

Did Murano have the courage to then, or now, to admit that all raw meat and poultry lacks a kill step, thus lacks a legitimate CCP, and thus does not qualify for true HACCP? No.

But she knows better, since she is a full professor at Texas A & M’s Center for Food Safety. Admitting FSIS HACCP-based failures requires a forceful and fearless leader.

Did Murano pressure FSIS into requiring tracebacks to the source of contaminated meat? No.

Only on May 2, 2012, on FSIS Docket # 2012-0009, did FSIS publicly embrace the value of tracebacks to the source. This was eight years after  Murano exited FSIS.

Did Dr. Murano ever publicly discuss the value of epidemiological tracebacks to the origin of contaminated meat involved in public health outbreaks? Not to my knowledge, although the agency has epidemiologists on staff.

Why bother to have epidemiologists on staff, if official policies prevent the detection and identification of the source? That is a question for Dr. Murano to ponder.

Admitting FSIS HACCP-based failures requires a forceful and fearless leader.

The afore-mentioned Dec. 27 Food Safety News article was entitled “Food safety expertise could trump ho-hum ag appointment.” I respectfully submit that Murano’s stint at FSIS was “Ho Hum.” I also suggest that USDA needs an aggressive, proactive individual willing and capable of forcing changes upon an oftentimes recalcitrant bureaucracy. I am not surprised that Murano’s stint as President of Texas A & M was so short. We should not allow her an opportunity for similar failure at USDA.

Note on author: John Munsell is the manager for the Foundation for Accountability in Regulatory Enforcement (FARE) and in 2008-09 was biofuels/renewable energy coordinator at Miles Community College. For 34 years he ran a USDA-inspected meat plant, which had been in the family for 59 years. Raised in Miles City, MT, and educated at Montana State University in Bozeman, John sold the family business in 2005, subsequently opening a deli/bakery at a local retail grocery store. Munsell’s passionate focus has been to reveal institutionalized shortcomings in USDA’s deregulated meat inspection program, and to protect the rights of small plants to remain in business in the absence of ethical government enforcement actions.

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Due diligence must be addressed these next 12 months to monitor USDA/FSIS’ willingness to implement meaningful reforms as suggested by the Office of the Inspector General (OIG).  Public revelation by OIG of faulty FSIS meat inspection policies should provide the required incentive to FSIS to not only author policies that better promote public health, but to also be more transparent.

The following comments will serve as my brief response to OIG’s audit report, and to FSIS’ response to OIG’s recommendations.  

In the middle of page one, OIG states “….regardless of how stringently the industry tests for E.coli, there is always an inherent risk of its presence in slaughter plants” (emphasis added).  

In this Audit Report, OIG makes references to the fact that E. coli contamination emanates from hides and viscera.  OIG is thus refreshingly candid, acknowledging that E.coli originates on kill floors, not at downstream entities that do not have manure-covered hides or intestines on their premises.  If FSIS had made this common-sense admission years ago, and had focused its search for E. coli at the source, rather than the destination, the number of outbreaks would have been greatly diminished compared to what we continue to currently experience. 

On page two, the Audit Report states “We also found that FSIS needs to consider shifting more of its testing resources to sampling trim, instead of [sampling] ground beef, for E.coli.”  This is not ground-breaking news to FSIS.  On Dec. 5, 2006, an industry meeting was conducted in Denver regarding control of E. coli O157:H7 in slaughter operations.  At the meeting, Dr. Daniel Engeljohn (FSIS official) stated that the agency would commence testing trim in 2007 because the incidence of E. coli is three times greater in trim than in ground beef.

FSIS has known this fact for over five years now. 

OIG also stated “A recent study stated that trim testing has a higher probability of finding E. coli O157:H7 than ground beef testing.”  OIG further stated that FSIS should “… begin testing more trim so that it can (1) maximize its [testing] results, (2) better promote public health, and (3) trace contamination problems to the source.”  This is but yet another disciplinary rejoinder to FSIS that if it truly desires to promote public health, it must write policies enabling tracebacks to the SOURCE of contamination.  

Folks outside the industry do not fully comprehend why testing trim, rather than ground beef (as OIG suggests), would benefit public health, requiring an explanation.  The report states on page 14 that one reason FSIS has sampled more ground beef (than trim) is “….agency officials are responding to the public’s expectation that it will test ground beef, as the final product, for E. coli O157:H7.” 

The report also says that FSIS officials have stated “….they want to achieve an optimal balance between sampling costs and protecting public health.”  This FSIS statement flies in the face of OIG’s previously mentioned conclusion that testing trim promotes public health.  

In a legal brief a few years back, Dr. Engeljohn stated that the agency prefers to test meat as close to the consumer as possible. 

This statement has great PR benefits to the agency, which is thus portrayed as the quintessential, aggressive 24/7 protector of all consumers.  What FSIS slyly avoids revealing is the fact that such testing is conducted as far away from the source slaughter plant as possible.  

Testing ground beef downstream, rather than trim at the source slaughter plant, insulates source slaughter plants from pathogen accountability.  It also minimizes the threat of potential legal actions against FSIS from source slaughter plants impacted by exposure of the true origin of contamination.  While testing ground beef has some advantage to public health, the primary beneficiary of testing ground beef downstream is the source slaughter plant upstream.

So, how did FSIS respond to this OIG suggestion?  On page 16, the “Agency Response” is “If necessary changes are identified, FSIS will develop proposed changes…..”  Clearly, FSIS will not acknowledge the necessity of changing testing to primarily focus on trim.  Furthermore, FSIS has established a deadline of April, 2013 to reveal changes.  Not only is FSIS disputing OIG’s suggestion to primarily focus testing on trim, but has given itself almost a full year to devise a stratagem to circumvent OIG’s common-sense recommendation.

Page 20 of the OIG Report includes two scenarios of which I was unaware, and should cause heads to roll at the agency. The two scenarios are:

“Additionally, while we were visiting the plants, we noted that plant managers sometimes exploit ambiguities in FSIS’ sampling policies or procedures so that they can avoid receiving noncompliance records if FSIS inspectors find a positive E. coli O157:H7 test result.  

For example, FSIS allows plants to avoid a noncompliance if they have a written policy in place to send bins [of tested trim] to cooking that FSIS samples from and finds E. coli.  One plant quality assurance manager told OIG that the plant had implemented a policy to send every bin to cooking that FSIS samples, so that it could never receive a noncompliance due to FSIS’ testing results.   

OIG maintains that FSIS should eliminate this policy ambiguity because noncompliance records trigger more serious enforcement actions and require corrective action that would improve how the plant controls E. coli.”  

The primary problem here is that while OIG perceives the need for corrective actions when a plant experiences recurring E. coli positives, FSIS sees no need for corrective actions.

As if the first scenario isn’t embarrassing enough, OIG reveals this second scenario on page 20: “A second policy ambiguity involves FSIS allowing plants to avoid noncompliance if an FSIS test and a plant test both result in a positive on a single sample.”

This logic is stupefying:  although trimmings tested by both FSIS and the plant both come back positive, removing all doubt of lab accuracy, FSIS implements no enforcement actions at the clearly noncompliant source slaughter plant.  

When company-conducted testing reveals the presence of E. coli, the impacted lot is diverted to a cooking plant, same as is done when E. coli is detected in FSIS-conducted testing.  Such diversions conveniently circumvent the need for corrective actions to prevent recurrences, a foundational requirement of true HACCP.  As such, the source slaughter plants and FSIS jointly place sole emphasis on prevention of SHIPMENT into commerce of contaminated meat, blithely ignoring ongoing PRODUCTION problems that are sanitary dressing failures on the kill floor.

When contaminated meat is detected, and diverted, FSIS congratulates the slaughter plant exclaiming “Your HACCP Plan is working!”  No NRs, and no corrective actions, although recurring lab positives prove ongoing sanitary dressing failures.

Pretty nifty, eh?

These policies are unconscionable, imperil public health and adroitly avoid the need for corrective actions to prevent recurrences.  Perhaps OIG is
only now realizing how FSIS has covertly abrogated its responsibility to protect consumers from foodborne outbreaks.  FSIS and the slaughter plants are equal accomplices in such sinister, scurrilous policies … which have not been transparent.

Bottom line:  all adverse lab reports deserve individual NRs.  FSIS refusal to issue NRs at source slaughter plants in spite of recurring lab positives imperils public health.  Corrective actions to prevent recurrences cannot be accomplished by diversion to cooking.  Meaningful corrective actions can only be accomplished on the kill floor, not by a sleight of hand, i.e., diversion.  FSIS disagrees.

On page 25, OIG’s Recommendation 7 to FSIS states in part “Improve communication by issuing guidance to industry to assist plants in selecting laboratories based on the capabilities of the testing laboratories.”  The agency’s response included a link to policy guidance announced on March 8, 2012.  Utilizing this guidance, I proposed an idea to the USDA’s Front Line Supervisor in Montana in April, which if approved would clarify FSIS expectations of small plants’ procedures to contract with outside labs.  

The Front Line Supervisor forwarded my suggestions to askFSIS on April 17.  As of Saturday, May 19, askFSIS had not yet provided an answer to Montana’s Front Line Supervisor.  When askFSIS was implemented, many plant owners and I sent questions to askFSIS.  Some received quick responses.  Unfortunately, most responses were delayed, were confusing, and some answers delicately skirted the issue.  

As a result, most plant owners with whom I visit no longer use askFSIS, for obvious reasons.  When the agency cannot even respond to a Front Line Supervisor within a month, we start to grasp how FSIS uses askFSIS as a PR front, but is frequently useless.  The agency’s refusal to provide meaningful answers, in an expedited fashion, also shows the agency’s bias against small plants.

I respectfully suggest that OIG should investigate askFSIS, which if it is the agency’s primary outreach to small plants, should be jettisoned and replaced by a group that will be held accountable.  

In conclusion, a popular industry mantra about eight years ago was that “We can’t test our way to safe food.”  I agree.  Testing alone doesn’t produce safe food.

Instead, consistently efficacious sanitary kill floor dressing procedures produce safe food. 

Testing can produce SAFER food, but only if adverse lab results lead to meaningful corrective actions to prevent recurrences.  Contents of this OIG report reveal that FSIS intentionally avoids issuing NRs subsequent to recurring lab positives for E. coli O157:H7.  

How frequently can a slaughter plant experience lab positives?  Page 36 of the OIG report refers to a plant which experiences 7, 15, 48 or more positives in one day.  The recent FSIS Traceback suggestions reveal that depending on a slaughter plant’s size and number of samples it takes daily, the plant could experience 5 – 8 percent or more positives before the agency will commence even considering whether these high numbers of positives might constitute a “High Event Period.”  Such thinking reveals the hypocrisy of the agency’s alleged “Zero Tolerance” standard towards E. coli O157:H7.  

Therefore, FSIS has knowingly enacted policies (some ambiguous and non-transparent) insulating slaughter plants from implementing corrective actions after E. coli O157:H7 is detected in their meat.  The same policies have effectively thwarted traceback attempts, with full FSIS endorsement.

Rather than giving FSIS almost a year to correct these inane practices, the agency should be forced to testify before the appropriate entity no later than June 15 to explain if OIG’s allegations are correct, and implement initial changes within two months.

John W. Munsell is manager of the Foundation for Accountability in Regulatory Enforcement (FARE) in Miles City, MT

So why would the U.S. Department of Agriculture’s Food Safety Inspection Service (FSIS) publicly state that beef trimmings are “high risk,” which would seem an embarrassing admission?

The fact that USDA knowingly allows “high risk” meat to be shipped into commerce in containers marked “USDA Inspected & Passed” is surprising.  But true.  And it is the driving force energizing industry innovators to devise new antimicrobial interventions to protect consumers from foodborne disease.

We need to dissect this driving force to understand, as Paul Harvey used to say, “The Rest of the Story.”

USDA declared E. coli O157:H7 to be an adulterant in 1994, forbidding its shipment into commerce.  The agency proclaimed “zero tolerance” for this type of E. coli. The agency also required all meat and poultry plants to implement a new system of production and inspection entitled Hazard Analysis Critical Control Point (HACCP).  In a phased-in implementation, the largest plants implemented HACCP by Jan. 26, 1998. 

Under contract with NASA and the U.S. Army, Pillsbury developed HACCP for plants making products that would be exposed to what’s called a “kill step” (such as cooking) to eliminate harmful bacteria, and thus create consistently safe, ready-to-eat consumer items.

USDA, however, mandated HACCP at all meat plants, even those producing raw meat and poultry.  These plants produce food not exposed to a kill step.

USDA-style HACCP thus suffered from a fatal flaw from day one, because in the absence of a kill step, raw food plants are incapable of producing food with a zero tolerance for E. coli.  In spite of this obvious discrepancy, USDA tenaciously adhered to its impossible zero tolerance demand on raw meat and poultry. The agency hoped against hope that the mere declaration of E. coli O157:H7 to be an adulterant would somehow regulate the pathogen into extinction.

E. coli and Salmonella are classified as “enteric” bacteria, meaning by strict definition that they emanate from within animal intestines and, by extension, proliferate in manure, which is found extensively on live animal hides. Intestines and hides are found in slaughter plants, but not in retail meat markets, restaurants or hospital cafeterias.

In all likelihood, such downstream entities innocently purchase previously contaminated meat from their suppliers. These destinations operate under the false assumption that incoming meat, bearing the USDA Mark of Inspection, is safe. Yet even USDA has issued written documents revealing that the agency does NOT equate the mark with product safety.

Although USDA has declared E. coli O157:H7 to be an adulterant, the agency conveniently states that the E. coli is an adulterant only in ground beef and in boneless trimmings destined for ground beef.  However, USDA allows intact cuts of beef surface-contaminated with E. coli to be shipped into commerce.

Retail meat markets, and to a lesser degree restaurants, purchase intact cuts as “boxed beef.”  Boxed beef includes intact cuts such as chucks, rounds, sirloin, etc., which are then further processed at those downstream locations into steaks, roasts and ground beef.

These intact cuts, which may be surface-contaminated with  E. coli, can legally be shipped into commerce, under the guise that the bacteria are not adulterants but merely contaminants when existing on intact cuts.  

However, where they are further processed at downstream entities, these contaminants somehow morph into lethal pathogens and, if detected in finished products, become the responsibility of the entity that did the processing.

Processing the intact cuts produces massive amounts of boneless trimmings, which are destined for ground beef.  Thus, it is easy to understand why USDA classifies the boneless trimmings as “high risk,” because the agency knowingly permits slaughter plants to ship intact cuts into commerce that may be surface-contaminated by invisible E.coli bacteria “contaminants,” not yet considered adulterants.

Complicating this scenario is USDA’s historical unwillingness to conduct tracebacks to the source of contamination, which, in the case of E. coli and Salmonella, is invariably the slaughter plant.

From Jan. 1, 2009 to  Nov. 30, 2010, USDA labs detected E. coli O157:H7 in 64 samples collected from USDA-inspected processing plants. 

In 29 of these 64 positives, the samples were obtained at plants that purchased all their meat from one source slaughter supplier. In all 29 cases, USDA refused to conduct a traceback to the one well-documented source, but instead assessed full liability against the victimized establishment further downstream that had processed the meat purchased from that supplier.

Several years ago, a then-USDA microbiologist who suggested that in such cases the agency should conduct tracebacks to the source slaughter plant was told the agency “won’t get involved in a witch hunt.”  Instead, the hunt for contaminated meat starts and finishes at the downstream destination.

As such, Americans are virtually guaranteed ongoing disease outbreaks from contaminated meat, because USDA refuses to implement enforcement actions at the source of the contamination, preferring to use its regulatory authority at smaller downstream plants that are easier enforcement prey and lack the political clout and financial wherewithal enjoyed by the multinational slaughter behemoths.

The top four slaughter plants in the U.S. kill 88 percent of our feedlot-finished steers and heifers, and constitute a formidable potential legal adversary to an agency fearful of litigation or political pressure. 

Since USDA allows slaughter plants to ship E. coli-laced intact cuts into commerce, the pathogen is somewhat ubiquitous (although still just a “contaminant,” mind you).

This intentional USDA oversight has spawned the need for development of additional antimicrobial interventions, such as treatment with ammonia hydroxide.  We should not pillory BPI or Eldon Roth for using this intervention, because it actually makes ground beef safer.

Admittedly, whether the treated beef should be labeled as such is another issue entirely.  Nevertheless, because USDA allows the bug free entry into commerce, American consumers benefit by entrepreneurs such as Eldon Roth for pioneering interventions that make our food safer.

Consumers who prefer that their meat not be subjected to chemicals such as lactic acid and ammonia hydroxide should not place the blame or target companies that are making “high risk” (to use USDA’s terminology) meat safer.

They should instead put USDA at the top of their radar, because the agency intentionally allows potentially risky meat to be labeled with the valueless USDA Mark of Inspection and shipped into commerce.

USDA has utilized vexatious ingenuity in concocting an allegedly “science based” deregulated system of limited inspection at the monolithic source slaughter plants to subtly forward all pathogen liability downstream to supposedly noncompliant processors and on to consumers, who are considered negligent if they don’t cook contaminated meat thoroughly.

The Eldon Roths of this world are saving lives, while USDA’s policies imperil public health.  These agency policies were fabricated in the 1990s, and continue to cause heartburn for the agency’s current leaders who have been burdened w
ith indefensible practices. 

Industry leaders who improve the safety of our food are the unsung heroes here, while USDA is the true villain, and needs to be brought to accountability. 

Food Safety News previously published my in-depth analysis of this USDA scandal.  That commentary can be accessed here and provided historical facts that better delineate how USDA has pulled its pseudo-scientific wool over our eyes.

One sentence in the editorial stated “USDA has concluded that Hannaford’s high risk practices likely led to this outbreak,” a reference to Salmonella infections linked to supermarket ground beef. Investigators were unable to trace the contaminated ground beef to any one supplier.

USDA officials subsequently contacted me, claiming that the agency did not say Hannaford’s practices led to the outbreak, and requested I issue a correction. What the agency stated was that Hannaford’s “high-risk practices” for grinding beef, including a lack of grinding logs, were a barrier in its investigation of the outbreak.  

I am writing this today not only as a correction, but also to describe how USDA-approved meat laced with E.coli and Salmonella automatically create “high-risk practices” at retail meat markets, hospital cafeteria and meat establishments that purchase boxed beef from source slaughter plants.  Americans need to know how “high-risk” meat is getting into our food chain.

Following the 1993 Jack In The Box outbreak, USDA required the meat industry to implement HACCP (Hazard Analysis Critical Control Point) systems. The agency’s previous meat inspection system had been organoleptic, i.e., dependent upon the senses such as smell, sight and touch.  Bacteria such as E.coli O157:H7 and Salmonella cannot be detected via organoleptic methods. USDA claimed that HACCP was built upon science-based inspection and meat production, not in organoleptic senses. The “science-based” foundation of USDA-style HACCP was microbial testing of meat, which can indeed detect the presence of invisible pathogens.

All meat plants were then required to devise their own customized HACCP plans, plus associated practices which would result in the production of consistently safe meat and poultry. Each year, the largest slaughter plants issue annual certifications and letters of guarantee, in which they describe the variety of policies and procedures utilized to produce safe food. Most, if not all, large plants now have these certifications and letters of guarantee available on their websites enabling customers to print copies. The information below comes directly from a variety of these websites.

The largest slaughter plants are highly efficient assembly and disassembly lines, deftly slaughtering and processing up to 6,000 beef daily. To their credit, they have invested millions (some claim BILLIONS) to develop and implement a plethora of scientific interventions which have clearly made our food safer. It is estimated that such scientific advancements add 6 – 8 cents per lb to the cost of beef.

The list of laudable interventions and policies is lengthy and exhaustive, including but not limited to:

– Prerequisite programs

– Pre-Operational sanitation programs

– Operational sanitation programs

– Hide-on carcass washes

– Critical Control Points (CCPs), which are points in the process where controls can be used to prevent, eliminate or reduce pathogens to an undetectable level

– Steam vacuuming beef carcasses on the kill floor

– Pre-evisceration and post-evisceration sprays, water and/or lactic acid sprays

– Thermal pasteurization systems: hot water or steam

– Standard operating procedures (SOPs)

– Standard sanitation operating procedures (SSOPs)

– Good manufacturing practices (GMPs)

– Pest control management

– Humane handling protocols

– Allergen control programs

– Testing of carcasses for E.coli, primary generic E.coli

– Salmonella testing programs

– Listeria testing programs

– Test and hold protocols

– Organic acid sprays of carcasses in the cooler

– Product recall programs

– Certificates of Analysis (COAs)

And many, many more.

In recent years, the largest slaughter plants have implemented an additional step with which I am greatly impressed.  When beef carcasses are broken down into component parts such as rounds, loins, ribs, etc, each individual piece of intact meat is placed into a vacuum packaged bag, and then boxed for shipment.  Immediately prior to placement into the vacuum bag, each piece of intact meat is exposed to an antimicrobial spray which further controls pathogens. These intact pieces of meat are, in my opinion, super sanitary, having been exposed to yet one more antimicrobial intervention. Consumers can eat this meat with a high degree of confidence in its safety.

I am quite impressed with a statement found in one slaughter company’s certification:  “We apply lactic acid to carcasses just prior to Fabrication, peroxyacetic acid to conveyor belts in our Fabrication process, and peroxycacetic acid to primal and sub-primals prior to packaging and to trim on the conveyor belt prior to placing into boxes or bins.” This company leaves no stone unturned in its commitment to safe food.

A statement from another slaughter plant: “Primal and sub-primal [intact] products are subject to an antimicrobial spray after trimming but prior to or at bagging. The antimicrobial treatment has been tested in our establishments and has shown to be effective in the reduction of bacteria and is monitored as per our application program.”

These plants are a credit to our industry.

Interestingly, the source slaughter plants test ground beef and boneless trimmings for the presence of pathogens, but do not test intact beef cuts. If pathogens were detected on intact cuts, the slaughter plant (and perhaps USDA) would know that its highly heralded HACCP systems had failed.

What is the true frequency of pathogens in intact beef cuts?  At a meat industry conference in Chicago on Sept. 17, 2008, then-USDA Under Secretary for meat inspection Dr. Richard Raymond revealed results of a recent agency experiment.  Dr. Raymond stated that the agency had tested 24 pieces of intact beef cuts for the presence of E.coli O157:H7.  Of the 24 intact cuts, 8 had E. coli O157:H7 on them, and six of the eight were loin cuts. Even if this test was an anomaly, USDA officials are painfully aware of the true incidence of pathogens on intact beef cuts.  So, how does USDA respond to this threat to public health?  The agency gives a Pass Card to the source slaughter plants, blithely allowing the plants to ship into commerce intact cuts which are surface-contaminated with E. coli O157:H7, as well as Salmonella, much to the chagrin of Hannaford and its customers.

An article in the Portland Press Herald quotes Daniel Engeljohn, assistant administrator of USDA’s Food Safety and Inspection Service:

“Engeljohn noted that there is a lower sanitary standard for the cuts of meat that are used for trimmings than there is for the ground beef that comes in tubes.”

I respectfully disagree. The “cuts of meat” to which Engeljohn refers are the intact cuts described above.  These cuts were exposed not only to the plethora of kill-floor interventions listed above, but also to the antimicrobial spray prior to their being packaged, as described above. If consumers can’t trust the safety of beef after that phalanx of scientific interventions, we’d better not trust beef at all. Part of Engeljohn’s concerns has to do with testing, which will be discussed below.

Several slaughter plants include disclaimers which state that no technology exists that can guarantee fresh meat products are free of pathogens, and that no one is able to guarantee pathogen free raw materials. These statements are absol
utely true:  raw meat, which has not been exposed to a kill step such as irradiation or full cooking, cannot be guaranteed to be pathogen free.

Slaughter plants take one additional step to protect themselves from liability for foodborne outbreaks emanating from consumption of their products. In spite of the fact their intact primal cuts have been exposed to the arduous gauntlet of antimicrobial interventions previously described in this report, some packers claim that their intact beef cuts are “NOT INTENDED FOR GRINDING.”

Slaughter plants thus admit that an inordinate percentage of their intact cuts are laced with deadly pathogens. So much for the efficacy of their “science based” interventions. Packers use this clever machination to insulate themselves from bacterial liability, even though in all likelihood the bacteria entered the food chain on their kill floor.

USDA does NOT object to such disclaimers. Unfortunately, USDA itself admits that the official USDA Mark of Inspection is meaningless. Agency publications have stated:

“Grinders with prerequisite programs should not rely on the mark of inspection (emphasis added) to accept incoming product.”

“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” (emphasis added).

When USDA itself admits that the Mark of Inspection is valueless, coupled with slaughter plants stating that their meat is “NOT INTENDED FOR GRINDING,” consumers should be fully forewarned that all raw meat carries a high risk of pathogen contamination. All liability for foodborne sicknesses has now been cleverly shifted onto consumers.

USDA has declared E. coli O157:H7 to be an “adulterant,” prohibiting the shipment of adulterant-contaminated meat into commerce. USDA recently proposed adding six more subtypes of E. coli to the list of adulterants. More specifically, USDA states that E. coli O157:H7 is an adulterant in ground beef and in boneless trimmings. Herein lies the rub however:  when E. coli O157:H7 is found on the exterior of intact cuts, USDA classifies the pathogen as a mere contaminant, certainly not a lethal adulterant. Therefore, slaughter plants can ship into commerce intact cuts of meat which are surface-contaminated with E. coli O157:H7, with full agency endorsement.

Subsequently, when downstream restaurants, hospital cafeterias and further processing plants open these intact cuts and process them into steaks, roasts and ground beef, only then do these heretofore feckless contaminants mysteriously morph into lethal adulterants!

Processing these intact cuts produce boneless trimmings, which have always been made into ground beef. Grinding trim emanating from these intact cuts is precisely what USDA refers to as “high-risk practices.”  Why?  USDA officials have stated many times that grinding such trim is high risk because the trimmings have not been tested, nor treated with antimicrobials.  We need to closely scrutinize this agency statement.

First of all, this agency statement contradicts an industry mantra of the last eight years which is that “We can’t test our way to safe food,” an erudite statement. Testing alone does not produce safe food. Testing does not remove pathogens from meat, nor does testing apply antimicrobial interventions against raw meat.  Testing is but an indicator of pathogen presence, a brief window in time which reveals the presence of absence of pathogens in a small, limited amount of meat.

USDA’s statement lulls consumers into thinking that we can build safety into meat via testing. Pillsbury’s original HACCP protocol built safety into meat at each step of the processing line. Testing does not build safety into food.

USDA’s contention that processing intact cuts and grinding the associated trimmings as being a “high risk practice” exposes the biased underpinnings of USDA-style HACCP. We must remember that intact cuts originated from those same beef carcasses which were exposed to the wide array of science-based interventions on the kill floor, in the cooler, and in the fabrication room. While still on the original carcass, these intact cuts were exposed to steam pasteurization, lactic acid sprays, hot water rinses, trimming, and all those interventions previously listed.

To top it off, in addition to all these kill-floor interventions, the packers now apply an antimicrobial spray to the intact cuts just before the cuts are vacuum packaged.  After packaging, if the intact cuts are still laced with adulterants, major insanitary conditions persist at the meat plant. USDA disagrees.

Instead, USDA and many in the meat industry continue to pass downstream all pathogen liability to the end users:  retail meat markets (such as Hannaford), restaurants, hospital cafeterias, and individual households. The end users are reminded to use proper food handling and cooking protocol, including prevention of cross contamination.  An article written by Leslie Bridgers at the Portland Press Herald regarding the Hannaford recall included the following quote from USDA’s Daniel Engeljohn:

“[USDA] Investigators found that Hannaford would grind trimmings and tube meat without cleaning the equipment in between, he said, raising the possibility of cross contamination.” 

Since when has USDA developed a commitment to the prevention of cross contamination?  The fact that the agency allows slaughter plants to ship into commerce intact cuts of meat surface-contaminated with E. coli O157:H7 virtually guarantees that entities which process those intact cuts will cross contaminate their facilities. Intact cuts are touched by gloves, aprons, knives, tables, saws, wrapping equipment, etc. Perhaps USDA perceives that everyone handling intact cuts should replace their gloves and aprons between each intact cut of meat, should wash and sanitize their cutting boards, table tops, saws and all related equipment between each intact cut?

Large retail meat markets like Costco and further processing plants will process dozens if not hundreds of boxes (each containing several pieces) of intact cuts on a daily basis. The probability of cross-contamination is daunting.  And the very idea of cleaning and sanitizing all equipment countless times daily, as well as replacing gloves and aprons, is simply not viable.

Commingling trimmings with other grindable meat such as “tube meat” does NOT introduce pathogens into the finished product. In all likelihood, pathogens arrived on the exterior of intact cuts in boxes proudly bearing the official USDA Mark of Inspection, which states “USDA Inspected and Passed.” This means that USDA knowingly allows E. coli residing on intact cuts to be emblazoned with the agency’s Mark of Inspection. Thus, we now have USDA Inspected and Passed Salmonella and E. coli. When E. coli-laced intact cuts are further processed, those same pathogens are deposited onto steaks, roasts and into ground beef.  The commingling of trimmings from multiple sources does NOT introduce E. coli, but spreads it. Don’t ask USDA to acknowledge this.

USDA’s Recall Press Release of the Hannaford recall on Dec,15, 2011 included these statements:

“Based on an examination of Hannaford’s limited records, FSIS was unable to determine responsible suppliers.”

“FSIS has not yet been able to identify FSIS-regulated suppliers of raw beef ground at Hannaford Stores related to the outbreak that could be subject to recall action.” 

USDA is thus critical of the lack of grinding logs at Hannaford stores
. While the existence of copious logs would have greatly aided in the determination of noncompliant source slaughter plants, we must remember that the lack of grinding logs did NOT contribute to the outbreak!  Grinding logs, or the absence thereof, have no connection to the introduction of bacteria into meat.  An establishment may have superlative grinding logs, and will still produce unsafe meat. Garbage in, Garbage out.

However, how can USDA be critical of Hannaford’s lack of evidence showing the sources of meat being ground?  For many years, the agency itself has steadfastly refused to authorize its own inspectors to document all source evidence at the time of sample collection!

Example:  at a Senate Field Hearing on Dec. 11, 2002, I suggested that when an agency inspector collects a sample of ground beef for E.coli O157:H7 analysis at a USDA Lab, that both the inspector and a plant official should immediately document the source(s) of the meat being ground.  Representing USDA at the hearing was William Smith, then-Deputy Administrator of the Office of Field Operations. He now heads up the agency’s OPEER department.  Smith made these two responses to my suggestion for evidence documentation:

“….we could have inspectors doing more important things”

“….a number of packers would also be very upset about us collecting information on negative [adverse] findings.”

On behalf of USDA, Smith admitted not only that the agency doesn’t want the inspectors documenting evidence in real time, but also that the source slaughter plants would be “very upset” if the agency were ever audacious enough to empower inspectors to document evidence with no restrictions.

In subsequent years, I’ve continually pressured the agency to document all source evidence in real time, only to be continually rebuffed.  Finally, on Oct. 8, 2010, USDA issued Notice 58-10, which authorized inspectors to collect all source evidence at the time of sample collection. How many years has USDA been inspecting meat, and not followed commonly accepted scientific sampling criteria which require documenting all evidence?  Copious documentation of unrestricted evidence should have been part and parcel of USDA’s meat inspection program since Day One, but has not. Yet, the agency criticizes Hannaford for its lack of grinding logs.

USDA collects routine samples of ground beef for laboratory analysis for E. coli O157:H7, referred to as “verification sampling.” From Jan. 1, 2009 to Nov. 30, 2010, the agency’s routine verification sampling revealed 64 samples that were positive for E. coli O157:H7.  Of these 64, 29 were collected at plants which purchased all their meat from but one slaughter provider. In all 29 cases, USDA refused to do a traceback to the one well-identified source. The agency deliberately refused to go to the source plant and require corrective actions to prevent recurrences. USDA adroitly avoided any enforcement actions at the source plant, in spite of these 29 golden opportunities to protect public health. 

Eventually, USDA mismanagement of public health issues caught up to them. On Aug. 3, 2011, USDA Secretary Tom Vilsack gave a speech in Milwaukee, in which he addressed this issue. He stated:

“In 90 days, I expect the agency to announce the first step in transforming our traceback policy…”

The FIRST STEP?  You mean to say that after several decades of being in the meat inspection business, that USDA finally decided to embrace traceback protocol in 2011?  Yes.  Well, what happened at the end of 90 days? No official USDA press releases. But on Dec. 29, 2011, a full 148 days later, USDA sent its traceback suggestions to OMB for approval.

Part of the USDA submission was requesting OMB permission to conduct tracebacks when verification sampling revealed the presence of E. coli O157:H7. This awkward revelation shows that USDA perceives it doesn’t have the authority to do tracebacks to the source, even when the source has already been clearly identified to be one individual slaughter plant!  Yet USDA claims to act with an “abundance of caution” when protecting consumers from foodborne outbreaks.

It is true that USDA referred to “high-risk practices” at Hannaford, but did not state that such practices likely led to the Salmonella outbreak. I am pleased to make this correction. It is only appropriate now that USDA officials publicly state if they believe that Hannaford’s practices had ANY connection whatsoever to the introduction of Salmonella into the meat chain. Don’t hold your breath. USDA is much more comfortable criticizing Hannaford’s allegedly high-risk practices and lack of grinding logs than in admitting that the lack of grinding logs and grinding practices did NOT introduce Salmonella into the meat chain.  Hannaford, and its customers, were innocent victims of purchasing and consuming meat which was already laced with Salmonella when the meat arrived at Hannaford receiving departments.

The real issue here is USDA’s ultra-risky policy of allowing slaughter plants to ship intact meat into commerce which is laced with Salmonella and E. coli O157:H7, and subsequently refusing to do tracebacks to the source.

Comparatively speaking, USDA’s PR image would have more benefitted by stating that Hannaford’s practices likely led to the Salmonella outbreak, than to publicly refer to “high risk” practices.  An in-depth discussion of “high risk” provides us the opportunity to reveal that USDA’s policies at the source originating slaughter plants constitute the ultimate cause of high risk meat.  

Salmonella and E. coli are  “enteric” bacterium, which is defined as originating from within animals’ intestines, and is thus present in manure.  Live beef arriving at slaughter plants frequently carry a sizeable amount of manure on their hides, creating an obvious risk during hide removal on the kill floor, where airborne enteric bacteria can easily become attached to beef carcasses.  And, when hides touch an exposed carcass, bacteria are directly deposited onto carcasses.  Retail chains, Hannaford being but one example, do not have intestines or manure-covered hides on their premises.  Therefore, we can conclude that Salmonella found in meat at retail meat markets was in all likelihood deposited onto carcasses on the kill floor, and the contamination did not occur at the retail meat market. 

Furthermore, the current recall of Hannaford meat covers seven states, with 20 reported illnesses.  The meat was processed at various Hannaford locations, in several states.  What is the probability that each of these Hannaford stores simultaneously introduced this one specific strain of Salmonella into their products, causing the outbreak?  Answer:  ZERO.  However, it does reveal that one of Hannaford suppliers suffered from a monumental breakdown in sanitary dressing procedures on its kill floor on one or more days, producing unsafe meat which was sent to the various Hannaford stores during this brief moment in time.

How does USDA view this public health dilemma?  USDA has concluded that Hannaford’s high risk practices likely lead to this outbreak.  Admittedly, Hannaford didn’t maintain grinding logs, which if used could have delineated the one source of contaminated meat.  Also, when the Hannaford meat cutters processed incoming meat, such as chucks and rounds, Hannaford kept the trimmings and put it into ground beef.  Totally legal, as the industry has done this since time immemorial.  My plant produced ground beef from trimmings for 59 years, under the watchful eye of USDA inspectors and their supervisors, none of whom objected.  Can you imagine buying a half of beef for your home freezer, only to be told that you cannot get any ground beef off that half, because USDA piously proclaims that ground beef produced from trimmings are “high risk” for bacteria?

The fact remains that if Hannaford has maintained perfect grinding logs, the outbreak would still have occurred.  The outbreak was NOT the result of a lack of grinding logs, but the presence of Salmonella in meat which Hannaford had purchased from a source slaughter provider.  And, even if Hannaford had tested the trimmings, and the lab result was negative for Salmonella, no guarantee for safe meat could be issued because labs frequently do not detect the Salmonella.  Even the largest beef slaughter plants issue disclaimers that even though their meat is tested, and tested negative, that the plants cannot issue a guarantee of safe meat because a silver bullet has not been developed to develop pathogen-free meat.  And, does USDA expect every retail meat market to conduct expensive microbial testing on every batch of ground beef produced?  Consider this fact:  the largest packers test every 10,000-lb. batch of trimmings by collecting 1 – 2 lbs. of trim for lab analysis.  It would only be equitable if every retail market tested 1 – 2 lbs. of ground beef every 10,000 lbs.  Would be quite infrequent.  What’s good for the goose (the source slaughter plant), is good for the gander (the retail meat market).

Please also note that when USDA inspectors collect ground beef samples at USDA-inspected establishments for Salmonella analysis, the agency allows up to a 7.5 percent incidence of positives before the agency will commence enforcement actions at the plant.  USDA’s aloof stance is that if only 7.5 percent of your ground beef is laced with Salmonella, consumers won’t be endangered.  However, if 8 percent or more of your ground beef has Salmonella, then, only then, will public health be imperiled.

CDC statistics show that 10 times as many Americans die from Salmonella as from E. coli.  USDA’s response to such lethal statistics?  First of all, 7.5 percent Salmonella won’t hurt anyone.  Secondly, the agency assesses all liability for Salmonella- and E.coli-laced meat to the downstream further processor, such as Hannaford.  USDA also issues a pass card to the large, source originating slaughter plants.  Only when this travesty of food safety justice is aggressively resolved will we Americans experience a lower incidence of foodborne outbreaks.

Bottom Line:  Hannaford’s processing of trim, and lack of grinding logs, did NOT introduce Salmonella into its ground beef.  Nevertheless, USDA now accuses Hannaford’s allegedly “high risk” practices to be the cause of the current outbreak.  This is but the latest in countless examples of USDA’s refusal to conduct tracebacks to the SOURCE, that is, to the large slaughter plants.  USDA’s insistence on assigning all pathogen liability to the downstream further processor virtually guarantees American consumers of future recurring outbreaks.

The link below will take you to a blog by Bill Marler, which reveals how USDA blithely blames Hannaford for this outbreak.

http://www.marlerblog.com/legal-cases/hannafords-high-risk-practices-likely-lead-to-salmonella-outbreak/

———————

John Munsell oversees the Foundation for Accountability in Regulatory Enforcement, FARE. A version of “USDA Inspected & Passed HIGH RISK Meat” was first posted on Munsell’s website on Feb. 1, 2012. Reposted with permission.

This financially prudent move prompted Andrew Lorenz, deputy district manager of the agency’s office in Minneapolis, one of the five offices to be closed, to tell the Associated Press, “They wiped out the entire Midwest.”

Such a statement resonates with some folks, who question if closing these five offices could adversely impact food safety imperatives. Such fears should be dispelled.

About 20 years ago, FSIS had a district office in Billings, MT with authority over Montana plants, including mine. This office was eliminated, its duties consolidated into the Minneapolis district office. This consolidation had NO adverse impact on the ability of Montana plants to produce safe food. This latest FSIS consolidation will likewise not adversely impact food safety or public health.

One of the 10 remaining district offices is in Denver, CO.  The entire states of Montana and Wyoming are much closer to Denver than they are to Minneapolis.  When the Minneapolis office is closed, Minnesota plants can be more efficiently covered by the remaining office in Des Moines than the Minneapolis office could ever have covered plants in Montana or Wyoming.

But this issue should not be decided primarily by physical juxtaposition of district offices to meat establishments. Rather, the primary focus of consolidation should be on FSIS’ actual physical presence and inspection of production at every meat establishment.

For example, let’s examine my plant, which I sold in 2005, and is still in full-time production.  There are five levels of agency oversight at this plant:

1. The in-plant inspector, who is there every day.

2. The inspector’s supervisor, a Supervisory Veterinarian Medical Officer (SVMO). This SVMO lives 3 1/2 hours away, and comes to this plant every 3 weeks or so.  Whenever the plant kills an animal that has potentially questionable health conditions, the SVMO must inspect it.

3. The SVMO’s supervisor, a Front Line Supervisor (FLS), who lives 2 hours away, and comes to the plant once a year or so.

4. The deputy manager of the Minneapolis district office, who is the afore-mentioned Andrew Lorenz.  I don’t believe Mr. Lorenz has yet to visit our local plant. And prior to Mr. Lorenz’s arrival, I would guess that I received visits by deputy managers only once every several years.

5. The manager of the Minneapolis District Office. I don’t remember my plant EVER being visited by any manager of the Minneapolis District Office. I have seen the last two managers of the Minneapolis district office in Montana for general meetings, but not at my plant.

Therefore, when the Minneapolis district office closes, all of the “hands on” inspection at this plant will remain as is, with no interruption, as levels 1 and 3 above will remain intact. The only change will be that levels 4 and 5 (which are not involved in inspecting meat) will be moved from Minneapolis to another district office, which I presume will be Denver.

The bottom line is simply that we taxpayers are paying for a redundancy of levels 4 and 5 across this country, as well as the expenses of running district offices, including space rent, utilities, phones, etc. Reducing the number of district offices from 15 to 10 will have zero impact on meat inspection, but will eliminate layers of costly and duplicative bureaucratic waste.

Additional layers of new bureaucratic positions, such as “humane handling specalists,” have been created in recent years. These folks visit slaughter establishments to ensure that plants are treating livestock humanely. A minority of plants slaughter animals, while a much higher percentage of plants only process. As such, the majority of plants in these districts do not require oversight for humane handling of livestock.

I respectfully submit that agency verification of an individual plant’s compliance with humane handling requirements can easily be conducted by agency personnel in layers 2 and 3, saving additional budgetary dollars.

Around 6 years ago, a new FSIS division was created — the Office of Program Evaluation, Enforcement and Review, or OPEER. This new division generated additional new positions, to perform work that had previously been handled by non-OPEER individuals. OPEER has four regional offices, all in the same buildings (but in different offices), which house 4 of the 10 district offices that will remain.

Perhaps OPEER duties can be reassumed by the same agency folks who performed this work prior to the creation of OPEER?

Taxpayer outrage is the mother of inventions and innovations, which FSIS must proactively embrace.  In my most recent visit to the Minneapolis District Office, I paid a visit to the OPEER office in the same building, but no one was in. It is important to realize that the OPEER office in Minneapolis is not one of OPEER’s four regional offices. This means that in addition to OPEER’s 4 regional offices, OPEER has many more offices throughout the country, all at taxpayer expense.

Maybe now is the time to eliminate OPEER, and reassign its duties back to previous FSIS entities to better utilize existing talent, absent additional and unnecessary personnel positions.

A review of America’s map, and the locations of the 10 remaining FSIS District Offices, reflects a paucity of agency bureaucratic coverage in the western third of America. Again, this FSIS reorganization does NOT reduce actual inspection coverage in the western states, but merely reduces the level of costly bureaucratic supervisory oversight.

District offices that will remain in Alameda, CA and Denver will now cover a larger geographical territory. This means that Denver and Alameda officials will have more states and plants to cover, but not to visit. Why do I say this? Please refer to my previous list of the five layers of FSIS personnel with authority over my plant, and see that levels 4 and 5 (from the district office) rarely visit plants in the field.

Why should they? The agency already has three levels of inspection oversight at all plants, so why should we burden taxpayers with the travel costs of District Office personnel who infrequently bless remote plants with their presence?

I respectfully suggest that layer 3, the position of a Front Line Supervisor, could be eliminated, with duties transferred to deputy district office managers, who are currently in layer 4. Only in America can we deceive ourselves into thinking that plants need three layers of inspection oversight, in addition to two layers of headquarters’ non-inspection bureaucracy.

With the development of technology, including laptops for all inspectors, now is the time for FSIS to closely scrutinize its multiple layers of redundant oversight, many of which require government vehicles, while accumulating  motel room costs, meals, etc.

I heartily congratulate USDA Secretary Tom Vilsack, Under Secretary Dr. Elisabeth Hagen and Administrator Al Almanza for the foresight and courage to tackle wasteful government spending, and design FSIS reorganization that will still protect public health while being a better steward of taxpayer dollars.

Corporations are forced into such painful decisions when economic reality dictates change.  Government entities must likewise appropriately respond.  We are fortunate that in this case, FSIS can accomplish sizeable budget reductions without jeopardizing public health or safe
food goals. These top three officials deserve our support!

And contrary to the self-serving statements of some, the entire Midwest is not being wiped out, nor is any other segment of America.

————————-

John Munsell ran a USDA-inspected meat plant for 34 years, which had been in the family for 59 years. He now oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

“In 90 days, I expect the agency [FSIS] to announce the first step in transforming our traceback policy”.

The USDA”s Food Safety and Inspection Service announcement is now six weeks overdue, and the agency has yet to publicly announce even “THE FIRST STEP” in transforming its mostly nonexistent traceback policies. It would be helpful to consider historical actions taken by FSIS regarding tracebacks, to place current agency inaction within a historical perspective.

On Jan. 26, 1998, the largest plants implemented their Hazard Analysis and Critical Control Points (HACCP) programs.

In March, 1998, FSIS issued a document entitled “Guidance for Beef Grinders to Better Protect Public Health.” This guidance includes 21 references to the terms traceback, trace forward, trace, tracking, tracing, tracking system and traceability.  In 1998, FSIS fully endorsed the concept of tracebacks … in writing.  

After a series of recalls in 2001, FSIS microbiologist Carl Custer suggested that FSIS should trace back trim sources and see what other grinders had received trim from those sources.  FSIS did not act on Custer’s suggestions.  Therefore, in 2003, Custer enhanced the argument and sent his suggestion to his director, who endorsed it and forwarded it up the agency chain of command.  A few days later, the director verbally notified Custer  “I’ve been told FSIS won’t go on witch hunts.”  In other words, the agency would not trace back to the source!

In January, 2002, my plant recalled 270 lbs. of ground beef potentially contaminated with E. coli O157H7.  When I suggested to FSIS that the agency trace the contaminated meat back to the source, it refused.  The agency refused to even allow inspectors to document the origin of meat being sampled at the time of sample collection.  However, on July 26, 2002, the FSIS Office of Field Operations (OFO) sent an email to all its district offices that included the following statement:

“As discussed in our conference call on July 23, 2002, the following are the actions each District must take when an FSIS E. coli O157:H7 monitoring sample is taken for ground beef.  At the time the sample is taken, the IIC [Inspector] will obtain from the establishment, the name, point of contact, and phone number for the establishments supplying the source materials for the lot of ground beef being sampled.”  

The two top OFO officials at this time were William Smith, and Dr. Kenneth Peterson.  Both officials are still at FSIS.

On Oct. 5, 2002, at a joint FSIS/industry public meeting, an agency official revealed that the July 23 procedure change had been rescinded “for legal reasons.” Therefore, inspectors were no longer allowed to document the origin of meat being sampled at the time of sample collection. In reality, FSIS rejected the concept of tracebacks.  

On Dec. 11, 2002, a Senate field hearing was conducted in Billings, MT, which was entitled “Food Safety Recall Procedures.” The panelists included the above-mentioned William Smith, and me.  During the hearing, I suggested that whenever an inspector collects a ground beef sample for USDA lab analysis, both the inspector and a plant representative should jointly document the source of the meat being sampled.  OFO’s William Smith was asked for his response.  The official transcript shows that Smith responded “…we could have inspectors doing more important things.”  (Yes, than telling the truth!)  Mr. Smith also stated “…a number of packers would also be very upset about us collecting information on negative [adverse] findings.”  Indeed, the large source slaughter plants would be upset if agency inspectors sampled meat from source slaughter providers at downstream further processing plants.

In this Senate hearing, a top agency official unwittingly admitted that FSIS opposes tracebacks to the source … in the real world.  

Roger Viadero was the USDA Inspector General from 1994 – 2001.  In a Feb. 15, 2004 article in “Meat News,” Viadero made the following statement:

“For food tracing is also a tenet of the Bioterrorism Act of 2002.  By law, all entities involved in the production, distribution or sale of food products in the U.S. must be able to track their products – and all components thereof – two steps back and one step forward in the supply chain.”  

Therefore, any artificial attempts by either FSIS or the industry to prevent tracebacks two steps back are direct violations of the Bioterrorism Act.  

On Dec. 1, 2009, FSIS officials participated in a public meeting with consumers.  During the meeting, an agency official stated that when a public outbreak is occurring, FSIS will perform tracebacks to the origin.  However, when a lab sample shows that the meat tested is laced with E. coli O157:H7, the agency DOES NOT perform a traceback to the source if no outbreak has occurred. How important is this agency policy? Consider this:  from Jan. 1, 2009 through Nov. 30, 2010, FSIS found 64 samples of ground beef that tested positive for E. coli O157:H7.  Of these 64 positives, 29 samples were collected from plants that purchased meat from only one source slaughter supplier. This provided FSIS with 29 golden opportunities to trace contaminated meat back to only one source slaughter provider. But FSIS refused to conduct tracebacks in all 29 cases. Why? Because there was no outbreak involved.  

The largest plants implemented HACCP on Jan. 26, 1998. Now, almost 14 years later, FSIS continues to refuse to perform tracebacks to the source even when possessing lab reports revealing E. coli O157:H7 in ground beef emanating from only ONE source slaughter provider establishment. Tracebacks to the source, which can pose problems, can nevertheless be accomplished; yet, FSIS willfully circumvents science-based tracebacks.  

FDA and FSIS jointly sponsored a traceback hearing in Washington, D.C. on Dec. 9 and 10, 2009. The FSIS deputy under secretary for FSIS, Jerold Mande, made the following comments:

“…improving product tracing has become a priority for the Obama Administration.”

“Each day, FSIS and industry tests products for microbial contamination.  Efforts to determine the source of positive product that an establishment produces need to be robust to prevent contaminated product from reaching consumers.”

“…we need to be looking toward a seamless tracing system that reaches throughout the nation and the world.”  

Again, FSIS endorses the concept of tracebacks to the source … in theory.

FSIS then hosted a public traceback hearing on March 10, 2010.  The brief, 31/2 hour meeting covered little fresh ground, other than to say that whenever a lab sample tests positive, FSIS would send an agency official (called an EIAO) to the impacted plant as quickly as possible to conduct a closer scrutiny of plant operations.

FSIS issued Notice 58-10 on Oct. 8, 2010 in which it authorized, in fact required, inspectors to collect source supplier information at the time of sample collection. This is the same procedure which was on the previously mentioned July 26, 2002 FSIS email to its district offices, but which was quietly rescinded only two months later.  Thus, FSIS required 8 additional years to consider such science-based sampling protocol before officially endorsing what should have been a foundational premise of its meat sampling methodology. This artificial de
lay is unconscionable, and i
n fact imperiled public health in the interim.  

The meat industry, FSIS, and public health departments all employ epidemiologists who continually search for causes of outbreaks, hoping to control the distribution of unsafe food.  FSIS’ artificial restrictions that limit traceback opportunities create an unnecessary hurdle for epidemiologists, making a determination of the SOURCE of contamination unnecessarily difficult.  If FSIS is allowed to maintain its artificial traceback barriers, how will America respond to future bioterrorist activities?  

FDA’s David Atcheson issued a report on Dec. 8, 2011 discussing FDA’s commitment to the need for preventive control requirements.  His article made at least 18 references to prevention and preventive strategies, including the need to understand the cause.  FDA appears to have a stronger commitment to prevention at the source than does FSIS, which focuses on corrective (after-the-fact, reactionary) actions at downstream further processing plants, after the pathogens have been let out of the slaughterhouse barn.  

Dr. Elisabeth Hagen heads up USDA’s Food Safety Inspection Service, enjoying my full endorsement.  Her intentions for watershed changes became obvious in her very first public speech after she assumed the agency’s top position.  The speech was given on Sept. 23, 2010 to the National Food Policy conference in Washington, D.C.  She discussed three areas which were to be her focus at FSIS. Her comments included the following:

“First, is prevention – it has got to be the foundation of everything that we do. Our food safety system, the way it currently works, relies too much on reaction (emphasis added) to problems to make people safe.”  

“And FSIS continued to evolve into what it is today:  an agency that is working hard to get to a truly preventative system.”

“Traceback. How do we get our policies for traceback to the source fully aligned with our goal of prevention? We also need a more effective traceback policy for contamination that we find through our regulatory sampling programs, if we want to have a truly preventive system.”

“One of our most powerful tools is data. We need to have the right data. We need to be able to gather the right data.  And then we need to analyze it in a way that leverages our vast inspection force to protect the public.”  

Subsequently, on March 15, 2011, in a speech to a Congressional subcommittee, Dr. Hagen stated:

“Prevention is the guiding principle of USDA’s Office of Food Safety and the Food Safety Inspection Service.”

Although Dr. Hagen admitted in September 2010 of the need for prevention, rather than reaction, and the need for tracebacks, and the ability to gather the right data, why, at the late date of Aug. 3, 2011, did Secretary Vilsack give FSIS 90 days to commence transforming its traceback policy?  Why hadn’t the process begun months before, in fact, years before?  FSIS unwillingness to trace back to the source is a systemic problem within the agency, which perhaps neither Dr. Hagen or Secretary Vilsack may be able to reverse.  FSIS lifer bureaucrats are paralyzed with fear of litigation from the industry’s largest slaughter establishments, if the agency were ever intrepid enough to trace back to the source.

In a Dec. 11, 2011 Food Safety News article by Dan Flynn, reference was made to Missouri’s state health director Margaret Donnelly, who told the Missouri House Appropriations Committee that in about half the outbreaks of foodborne illness, the source is never found.  The article also stated that this means that about half the time we all pay, in higher insurance premiums and higher taxes. I’d like to expand on this statement.  It also means that since the source is not determined half the time, and corrective actions not implemented, we are virtually guaranteed ongoing outbreaks. Since we don’t force the source to clean up its act, consumers pay the price. Sound familiar?  

So, where is FSIS today? To its credit, it has finally allowed its inspectors to document the origin of sampled meat at the time of sample collection. FSIS still refuses to get involved in “witch hunts,” that is, refuses to engage in traceback activities that would likely end at the doorstep of the industry’s largest slaughter plants. Why? Successful tracebacks would reveal that the industry’s largest slaughter plants continue to ship an unacceptably high amount of pathogen-laced meat into commerce, and would reveal the agency’s underwhelming oversight at these behemoth slaughter establishments.

My concern is that FSIS’s unwillingness to author even a preliminary “first step” in transforming its traceback policies reveals a systemic agency opposition to tracebacks to the source. If Secretary Vilsack had asked me (or countless others) to author initial recommendations to improve FSIS traceback protocol, viable suggestions from dozens of further processing plants and FSIS field personnel could have been accumulated and submitted to FSIS within 30 days. This is not rocket science. But it does require a commitment to true science, and common sense, absent artificial bureaucratic restraints.     The 90-day mandate was overly liberal, a time frame that has been exceeded by an unbelievable six weeks already. Is it possible the agency’s pious proclamations endorsing prevention and tracebacks were merely PR ploys? Since Secretary Vilsack has not held FSIS accountable for its noncompliance with his overly generous 90-day mandate, could it be possible that Secretary Vilsack and the Oval Office are accomplices with FSIS, preferring not to engage the industry’s largest slaughter plants?  

America’s consumers, taxpayers and public health deserve better.  

Traceback is dead at USDA.  

Secretary Vilsack, let us hear from you … soon!

——————–

John Munsell oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

“Substantial benefits can be gained by publicly posting (a) enforcement data from reports written by inspectors, and (b) testing data from standard laboratory tests.” 

“The report comes in light of the Obama administration’s push for increased transparency across federal agencies.”

Release of this data “could introduce a new incentive for processors to avoid disease-causing contaminants,” while “motivating processors to improve their food safety performance.”

“Companies could be damaged by poor or inaccurate inspection reports,” which could create “unintended adverse consequences.”

I would like to comment on the quotes listed above.

When President Obama stated in 2009 his desire for increased government transparency, my impression was that he wanted activities of federal agencies to be transparent and open for public scrutiny, admittedly a dramatic change.  NRC’s recommendations do not increase transparency of FSIS actions and policies, but provide transparency into individual companies’ microbial test results and alleged non-compliance with FSIS in-plant operational expectations.  Big distinction.

I have publicly stated for several years that FSIS should release microbial test results of all agency-conducted testing, by company.  Not only would such data provide benefits to public health, but should be mandated because the testing was funded via taxpayer dollars. Testing performed by the company, at company expense, should not be released to the public, but must be available to FSIS inspection personnel, as authorized by FSIS Notice 54-03 and FSIS Directive 5000.2, Rev 2.

All FSIS-conducted test results should be posted on USDA’s website, in real time, not requiring FOIA requests, which are time-consuming and the results are not always truthful.

Complimentary test results can be used by a meat facility as proof of their successful commitment to food safety.  Adverse results, on the other hand, would indeed provide a public incentive to plants to improve their production procedures.

 It is unconscionable for a government entity to utilize taxpayer dollars to conduct science-based microbial test results, only to subsequently deny public access to the test results.  What is FSIS hiding?  While not qualifying for “taxation without representation,” the agency’s unwillingness to release such data constitutes “taxation without revelation,” intentionally obfuscating truth which should be public.  I can understand why FSIS would artificially restrict dissemination of such data, because adverse data reflects negatively on the agency’s oversight (or lack thereof) of the meat and poultry industry.

While lab microbial test results are objective and science-based tools, data from reports written by inspection personnel are frequently subjective and inherently disingenuous agency ploys. The current FSIS HACCP protocol is no longer focused on meat inspection, but on auditing company-produced paperwork.  Although the agency initially portrayed FSIS-style HACCP as a pathogen chase, the system quickly degenerated into a paper chase, usually with zero connection to food safety.  Responding to mandates from FSIS HQ’s bean counters, agency field personnel are expected to generate a plethora of ongoing reports, one of which is Noncompliance Records (NRs).  The number of NRs per plant, or per agency district, varies greatly across America, largely dependent on mandates (quotas) established by supervisory personnel for their own biased reasons.

Dr. Richard Raymond, who headed up FSIS from 2005 – 2008, authored a series of six blogs on meatingplace.com this year focused on the agency’s unethical targeting of Montana plants for an exorbitant number of NRs.  Following Dr. Raymond’s revelations, the incidence of NRs in Montana dramatically dropped, not because plants made ANY changes, but because the agency’s misbehavior had been publicized.  Now that’s what I call transparency!  I originally perceived that such unethical agency actions were unique to Montana, only to be subsequently educated by FSIS personnel and plant management in numerous states that such agency misdeeds occur sporadically across America, wherever mislead, power-hungry FSIS personnel are ensconced.  Some FSIS officials are proficient in their ability to fabricate intentionally false allegations against innocent plants, ostensibly portraying the plants as (a) lacking a commitment to food safety, and (b) utilizing insanitary production protocol.

Public release of such falsified “evidence” would not only damage the reputation of legitimate firms, but even more importantly, will NOT improve public health goals, since the focus would be on falsified allegations.  Since we all share the goal of improved food safety, with the obvious benefit to public health, our focus should be on determining the true SOURCE of contaminated meat, which is not revealed by falsified agency paperwork allegations, but on microbial lab test results.

A hot topic within FSIS at this time is validation.  The agency’s Dr. William K. Shaw gave a PowerPoint presentation to the FSIS National Advisory Council for Meat & Poultry Inspection (NACMPI) on Sept. 22, 2011, entitled “HACCP Systems Validation.”  Dr. Shaw defined validation this way:

“Validation involves scientifically demonstrating that a HACCP system as designed, is effective in addressing the identified food safety hazards.”

The agency itself admits that proving, or validating, the effectiveness of individual HACCP Plans requires scientific protocol, which is available via lab analyses.  Notably, validating individual plant success is not focused on a plethora of daily paperwork, which can be easily falsified.  An excellent revelation on the shortcomings of reliance upon paper flow to determine a plant’s ability to produce safe food can be found in Chapters 7 and 8 in Timothy Pachirat’s recent book “Every Twelve Seconds.”  Anyone sincerely interested in the value of releasing plant-specific data must consider chapters 7 and 8 of Pachirat’s book as a must read.

If FSIS were to greatly increase its microbiological testing of carcasses, intact cuts (boxed beef), trimmings and ground beef at source slaughter plants, and releasing all results in real time absent artificial restrictions, the entire world would know within one month which slaughter plants have ongoing problems on their kill floors.  FSIS is loathe to do this, preferring instead to focus its testing at downstream further processing plants which unwittingly purchase meat which was previously contaminated at the source slaughter plant.  The agency’s newfound desire to publish data, as suggested by NRC, merely diverts our attention from the true source of contamination, the VAST majority of which is introduced at the slaughter plants.

Let’s make public release of scientific data provide maximized benefits for public health considerations!  Let’s initially increase agency-conducted testing at all slaughter plants, digest the results, and then advance to the next step, which is to include data from processing plants as well.

FSIS will disagree with me, for obvious reasons.  The agency does not want consumers to realize that agency oversight of the industry’s largest slaughter plants has lead USDA’s own Office of Inspector G
eneral to state in two separ
ate reports:

“USDA had reduced its oversight [under HACCP] short of what was prudent and necessary for the protection of the consumer.”

My recommendation is to release science-based evidence to the public, which will not only motivate facilities to improve their performance (as the NRC report suggests), but will also allow FSIS obfuscation of evidence to be more “transparent,” as President Obama recommends.

———————

John Munsell oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

1.) Louisiana, Mississippi, and other states are responsible for the environmental degradation because they allowed contaminants to enter their boundaries.

2.) Petroleum is a contaminant only when it arrives at the destination, namely, the coastlines.  Prior to its arrival, petroleum is a relatively harmless minor irritant.

3.) Louisiana, Mississippi and other states must implement corrective actions to prevent future recurrences.

4.) BP is not liable for this impending catastrophe, because (a) BP is producing a legal commodity, and (b) all liability for this catastrophe must be assumed by the destination states.

Any sensible person would discredit the four statements above, properly classifying them as inane science fiction absurdities. I fully agree. However, USDA/FSIS uses these precise claims when the agency investigates foodborne outbreaks caused by E. coli 0157:H7.

First of all, downstream establishments which unwittingly purchase USDA Inspected and Passed meat products which were previously contaminated with pathogens are held liable by FSIS for the presence of the lethal bacteria. Admittedly, this is absurd. Nonetheless, FSIS operates under this mindset. 

Secondly, FSIS claims that E. coli is an adulterant only when found in boneless trimmings and ground beef.  Previously, when the bacteria were detected on carcasses and on intact cuts of meat, FSIS considers the pathogen to be a relatively harmless contaminant, certainly not a lethal adulterant.

Thirdly, FSIS assigns primary responsibility to downstream further processing plants, retail meat markets, restaurants and institutions to prevent their future receipt of meat which was previously contaminated with INVISIBLE bacteria.  

How is this impossible task to be accomplished?  FSIS states that the destination facilities must author more thorough purchase specifications, test incoming meat (at their own expense), hire 3rd party auditors to monitor their source slaughter suppliers’ adherence to food safety practices, demand Certificates of Analysis, ad infinitum.  

In other words, if the destination facilities would merely fill their files to overflowing with a plethora of paperwork (much of which has no connection to safe food), then their source slaughter providers would supposedly never again produce unsafe meat … in theory.

In stark contrast, if FSIS would adequately inspect the source originating slaughter plants, and require the source slaughter plants to prove that fecal bacteria is not present on their carcasses, then the victimized downstream DESTINATIONS of previously contaminated meat would not be required to employ this feckless after-the-fact paper chase.  

The current method of meat non-inspection at the large slaughter plants, called HACCP, has allowed FSIS to semi-retire at the source originating slaughter plants,  effectively deregulating these transnational behemoths, while empowering the agency to hyper-regulate the small, downstream destination facilities, a much easier prey.

When FSIS fully succeeds in its goal of removing federal inspection from all small plants, but outbreaks and recalls continue unabated, who will FSIS then blame?  For starters:  Louisiana and Mississippi.  Or better yet, allegedly negligent consumers who don’t fully cook raw meat, or fail to remove petroleum from their seafood.

The shuttle disaster is another case in point. On February 1, 2003, when the shuttle re-entered earth’s atmosphere and broke apart, toxic debris was showered over several east Texas counties, setting off an intensive NASA investigation to determine the true cause of the catastrophe. 

 If NASA investigators had been restricted to utilize only those investigative protocol allowed by FSIS during investigations, NASA would have concluded that the disaster was caused by inadequate air quality control standards enacted by these east Texas counties.  Furthermore, NASA would have required those counties to implement corrective actions to prevent future recurrences of their reception of toxic debris in the future.  Absurd?  Yes … just like FSIS meat inspection policies.

On July 1, 2011, an Exxon crude oil pipeline ruptured under the Yellowstone River near Laurel, MT, disgorging an estimated 42,000 gallons of crude oil into the swollen river.  During the ensuing investigation, no one suggested that downstream municipalities be responsible to implement corrective actions to prevent future pipeline ruptures.  The upstream pipeline owner must be held accountable.  

Likewise, the upstream source slaughter plant must be held fully liable for all bacteria residing on beef carcasses in their coolers, as well as on the variety of meat cuts subsequently produced from these carcasses and shipped downstream.  FSIS disagrees with me on this issue. 

The agency’s current goal of requiring meat plants to “validate” the effectiveness of their meat production HACCP Plans provides a window into agency motives. In a nutshell, FSIS is suggesting that downstream further processing and grinding plants test incoming meat (purchased from source slaughter providers) for the presence of pathogens.  

As such, the agency expects these downstream plants to validate the efficacy of their source slaughter providers’ ability to ship safe meat into commerce. The fact that the incoming meat arrives in boxes emblazoned with the official USDA Mark of Inspection which states “USDA Inspected & Passed,” and that FSIS nevertheless wants downstream plants to test incoming meat, reveals that the agency knows its official mark to be valueless.  

Until USDA/FSIS voluntarily embraces the need for unrestricted tracebacks to the source, and aggressively forces the source to clean up its act, outbreaks and recalls will continue to persist in America. We deserve better.

—————  

John Munsell now oversees the Foundation for Accountability in Regulatory Enforcement, FARE, in Miles City, MT. “Force the Source.” His website is www.johnmunsell.com

Photo Credit: NOAA

After my meat plant recalled 270 pounds of ground beef potentially contaminated with E. coli O157:H7 in January, 2002, someone notified me that a lawyer in Seattle had posted the U.S. Department of Agriculture’s press release about my recall on his website.

I was incensed. For those of you who know my story, you know that I was madder than hornets at USDA for its misbehavior at my plant. Now, with Bill Marler publicizing my recall on his website, I perceived that USDA benefitted from “relationships” with companies that aided the agency in discrediting legitimate meat plants.

I felt that Bill’s law firm was a not-so-silent accomplice with USDA in hanging out dirty laundry that didn’t belong to me. Prior to this event, I had never heard of Bill Marler, or the Marler Clark law firm.

I immediately called the law firm, and asked for Mr. Marler, who quickly took the call. I introduced myself, and stated that I was aware that he had posted the recall press release that implicated my firm. Because I was anger-driven at the time, I don’t recall the entirety of our conversation.

What I well remember, however, was my intense dislike for this Seattle attorney who gladly posted a USDA press release that was a huge embarrassment to my company, which at the time had been in business for 56 years. I felt that the least this blasted attorney could have done would have been to call me first, and obtain all the details conveniently missing from the USDA’s press release. But no, he had accepted the agency’s press release as fact, and published it without cross-examining either the USDA or me.

Bill cordially listened to my story and was willing to look at evidence I offered to mail to him.  I well remember the bitterness that permeated me while I accumulated the evidence to mail. I entertained vain imaginations that Bill and I would someday face each other in court, when I would attempt to discredit him for partnering with USDA to put nails into my coffin.

Funny, the thoughts that go through a businessman’s mind when faced with potential bankruptcy.

Bill never called me back to provide his perception of the documents I had mailed him.  I forgot about him until July 9, 2002, when I was waiting to board a plane at L.A. International.  As I read the op/ed page in a major paper, a headline jumped out at me: “Put Me Out Of Business.”  It was an article written by Bill, which jogged my memory of our visit months earlier. Only now, I wanted Bill to eat that very article in the paper. Why? Because ConAgra had just announced a recall of E. coli-contaminated ground beef, a recall this attorney must have been aware of. As such, I figured that Seattle attorney must now feel foolish for ignoring my statements earlier that year. I relished the moment.

To Bill’s credit, following the ConAgra recall he did remove the press release about my recall from his blog. In a subsequent post entitled “One E. coli O157:H7 Outbreak I Think I Could Have Prevented,” Bill stated he was sorry he did not pay attention to my earliest warnings and, if he had, consumers may have been saved from dozens of sicknesses, and one life may not have been lost.  Bill has since told me that the biggest mistake he ever made was not listening to me in early 2002.

I don’t blame Bill; who would ever believe that USDA had gone into semi-retirement at the biggest meat plants, by intentional agency design? It is an incredible story, but one well documented now in 2011, a full nine years later.

Perhaps a few weeks later, Bill called and asked if he could come to Miles City, see my plant, and visit with me. Plans were made. He arrived at my plant one afternoon, we visited, and toured the facility. We had supper at my house later that night, and my wife Kathy and I had a most pleasant conversation with Bill, centered on food safety and consumers.

It was over supper that I met the real Bill Marler, who wasn’t the enemy I had originally envisioned. Both Kathy and I were convinced that Bill truly has a heart for consumer health as he related his visits with families who had suffered from foodborne illnesses. Although I was a meat plant owner and Bill an attorney, we had much more in common than one might imagine from such a combination.

Bill briefly visited the meat plant again the next morning before leaving.  Since then, we have kept in touch as outbreaks, changes in USDA meat inspection policies and other situations occurred.  As I subsequently developed relationships with food safety people, microbiologists, and consumer groups, I came to discover that a great many people hold Bill in high esteem. Those relationships were carefully nurtured over many years, during which time folks closely scrutinized Bill’s actions, and were favorably impressed.

Now, when I think back on that newspaper article challenging the meat industry to put him out of business, my attitude has greatly morphed. More than just an attorney, Bill is an advocate for the rights of consumers to anticipate wholesome food. We in the meat industry should do all we can to put this attorney out on the street, and prove to consumers that we sincerely want to earn their business via production of consistently safe food.

So Bill, I just want you to know that not only the meat industry, but also consumers, would like to see your firm go belly up. But you can still come to my place for supper.

————————

John Munsell now oversees the Foundation for Accountability in Regulatory Enforcement, FARE. His website ishttp://www.johnmunsell.com www.johnmunsell.com

The primary focus of this narrative is the bigger picture, which is the current style of meat non-inspection concocted by the USDA Food Safety and Inspection Service. The agency’s deregulated scheme was conceived in deceit, spawning inevitable and ongoing outbreaks.  

True science is constant, such as water is two parts hydrogen, one part oxygen.  In stark contrast, FSIS-style pseudoscience is constantly changing, being newly defined by each new agency official who visits a plant and requires that earlier “scientific” mandates required by previous agency officials be rescinded.

As such, inspectors properly define FSIS-style HACCP as “Hardly Anyone Comprehends Current Policies.” FSIS-style HACCP is truly incomprehensible for its remarkable inconsistencies, and lack of common sense.  Not only is FSIS-style HACCP non-scientific, it is also nonsensical, and imperils public health.

I frequently ask myself if this entire situation is too bizarre to be true.  Can the agency that considers itself America’s premier public health agency actually be involved in insulating the source from accountability?  Does the agency truly avoid tracebacks to the source?  Is it possible that FSIS bureaucrats deny field inspectors the right to document unrestricted evidence of visible fecal contamination?  Is it possible that FSIS-style “science” is actually nonsense, and non-science?  Incredible allegations. You be the judge.

Nevertheless, whether we can agree or not on all the evidence this narrative has revealed, we at least must seriously contemplate how the agency’s current deregulated system of meat non-inspection can be improved. We can agree on that. I’d like to pose ideas for all Americans to consider. 

When FSIS designed its perverted style of HACCP fantasy, the agency totally discarded organoleptic inspection.  FSIS essentially threw out the baby with the bathwater, to obtain agency comfort.  When the time comes for FSIS or another agency to modify the current FSIS-style HACCP protocol, it is imperative that sensory perceptions be re-implemented as an acceptable complementary meat inspection partner.

FSIS currently considers the organoleptic detection of visible fecal material on carcasses to be faulty, constituting “non-scientific” observations.  We now know that plants with 7-log pathogen reduction interventions regularly fail to resolve visible fecal contamination.  FSIS must allow its inspectors to again use their senses, including common sense.

FSIS did not accidentally blunder into its failed deregulated policies, which were intentionally designed in the 90s. The agency hoped against hope that deregulation would actually benefit the public:  the same hope that drove deregulation of the investment and banking industries, for which we are still paying a price. Because FSIS placed more focus on hope than on science, the agency essentially painted itself into a corner, from which it is attempting to extricate itself and still save face.

To understand how FSIS-style HACCP was imposed on America, we need to understand how FSIS overruled recommendations from its own National Advisory Committee on Microbiological Criteria for Food (NACMCF).  We slipped into the FSIS-style HACCP at least in part because of an over-reaction by the Clinton administration to the Jack in the Box E. coli O157:H7 outbreak.

This outbreak peaked in the middle of January 1993; just as the Clinton administration was being inaugurated.  Its over-reaction is epitomized by the E. coli O157:H7 in ground beef adulterant rule, published in 1994, and by the Pathogen Reduction:  HACCP Rule, published in 1996.

The latter rule was developed with initial input in 1994 from the NACMCF, which was co-chaired by the USDA’s FSIS administrator and FDA’s CFSAN director.  Broad parameters of a potential rule were discussed.  Several committee members representing academia and the food industry expressed strong resistance to the idea of Salmonella performance standards for monitoring process and sanitation controls.  They argued that process controls could be much more effectively developed, validated and verified by the use of a microbiological indicator test such as the aerobic plate count.

After several initial meetings on this topic, NACMCF quite unexpectedly went dark for about one year. Encountering the FSIS administrator at a professional meeting in 1995, one of the committee members mentioned above asked why there had been no meetings for one year, as the committee had previously met regularly, as often as eight times in one year, since its formation in 1988.

The administrator explained that NACMCF meetings were open to the public; FSIS wanted to develop its final rule without public discussion or input.  Upon parting the administrator said, “We are changing HACCP, and there is nothing you can do about it.”

We need to remember: FSIS unilaterally changed Pillsbury-style HACCP. This is a fundamental point, which FSIS has successfully kept under wraps.

So much for transparency in government processes.  With its cavalier blocking of public input, FSIS had also blocked input from some of the best scientists and food safety professionals in the country, including those most knowledgeable about true HACCP and food safety management.

The meat and poultry industries and the American taxpayers have been burdened ever since with dysfunctional regulatory procedures that are counterproductive to their claimed missions of enhancing food safety and protecting the public health.  

If FSIS decides to change course, and protect consumers rather than protect the source slaughter plants, the agency must require source slaughter plants to validate the safety of meat shipped into commerce from these source plants.  The slaughter plants and FSIS alike should commence a large number of microbial tests of boneless trimmings, intact-boxed beef cuts, and carcasses at all source slaughter plants.

All FSIS test results must be posted on the agency website in real time, realizing the tests were financed via taxpayer dollars. Results of plant-conducted tests must be provided to inspectors and vets in real time, but would otherwise be considered proprietary. These lab results will quickly reveal to the agency, and to the consuming public, the true source(s) of contaminated meat. This is but step one, and step two will be a daunting task. 

Step two would require that FSIS implement efficacious enforcement actions at the source, requiring the source slaughter plants to implement truly meaningful corrective actions to prevent recurrences. Admittedly, such actions would create gross discomfort for an agency that has been asleep at the wheel, and would impose production problems for the high-speed source slaughter plants.

We must give credit to these source plants for already investing multiple millions into the development and implementation of various interventions that have diminished the incidence of pathogens. However, necessity is the mother of invention. JFK announced in his inaugural address in 1961 that he wanted a man on the moon by the end of the century. Although the task was arduous and gargantuan, Neil Armstrong walked on the moon in the summer of 1969, and we were all glued to our televisions.

Likewise, development of additional interventions at the s
ource will be difficult, tim
e consuming, expensive, and won’t be accomplished overnight.  But it has to be done.  We’ll never have zero pathogens, but I’ve not heard anyone claim that improvements are either unnecessary or impossible. Until the source is required to clean up its act, ongoing outbreaks and recurring recalls are virtually guaranteed. And, the nation’s focus will be glued on FSIS and the industry, expecting improvements.  

My perception is that the vast majority of Americans agree with the previous paragraph.  However, the agency’s pre-HACCP promises to the meat industry effectively stymie increased FSIS oversight of meat production lines. FSIS loathes a “hands on” involvement at the large source slaughter plants, avoids policing the large plants, and circumvents its previous command and control authority at the powerful largest source slaughter plants, many of which are now multinational behemoths that enjoy enormous political and economic clout.

Therefore, the first step is to rewrite and redesign the agency’s theoretical HACCP Hoax, to prevent recurrences of outbreaks. A major mid-course directional change is required, akin to FSIS reassessing its own failed HACCP Plan. However, neither FSIS nor the big packers would approve of such improvements, which leads to my next suggestion.

FSIS will never voluntarily implement the steps referred to in the previous paragraph. I propose that FSIS be disbanded, and its previous duties assigned to a newly formed agency that indeed desires to inspect meat, not satisfied with a cursory window dressing audit of paper flow.

The Food and Drug Administration is not the agency for this. While FDA professionally oversees medicines and medical devices, it has neither interest in nor practical experience with inspecting food facilities.  Recent illness outbreaks associated with lettuce, peanut butter, cookie dough, eggs, etc have educated this country that FDA’s nonchalant “reviews” of plants once every six years or so is woefully inadequate. The new agency must embrace a “hands on” role, willing to police the industry, and be empowered with command and control authority.  

The new agency must be divorced from, and totally independent of USDA, because of a conflict of interest. USDA promotes global sales of USA’s agricultural products, a noble cause that deserves our continued support. When food safety issues arise that potentially threaten our exports, USDA must place priority on exports, not on food safety. This conflict must be removed, giving food safety even footing with our export activities. 

A somewhat similar scenario is transpiring in China. In the April 27, 2011 edition of “Global Times,” which is printed in Beijing, the issue of pigs dying from diseases and subsequently delivered to slaughter plants was discussed. An estimated 20 to 30 million dead and diseased pigs enter the food chain each year in China.  In recent years, cases of factories processing long-dead pigs have been found in many cities in China. Two quotes from the article include:

“Sang Liwei, a lawyer who helped revise the Food Safety Law, said that the core problems in this pork safety issue lie in the lack of supervision from relevant [government] departments, and suggested building a strict accountability system for government officials.”

“In China, officials from [government] departments that failed to supervise the quality and safety of food normally received administrative penalties such as being transferred to other posts or removal from the post. That is not enough.  Their criminal liabilities should be investigated too, Sang said to the Global Times, adding that only when the cost of crime was increased would people be more cautious.”

We should be cognizant of the fact that under the global HACCP umbrella, protein from China and other countries can be shipped to the USA once those countries have ostensibly “proven” their inspection systems are equivalent to our own. Personally, I prefer domestically produced pork. The situation in America is somewhat different than in China, in that FSIS inspectors want to take action when observing ongoing fecal sanitation non-compliances, but FSIS avoids initiating meaningful enforcement actions at the source slaughter plants. Upton Sinclair’s “The Jungle” focused on problems in the meat industry, but this narrative is focusing on problems in deregulated government non-inspection policies, such as the above Beijing article reports.  

Simultaneously, it is imperative that protections for plant owners be implemented that provide expedited legal recourse when FSIS employees attempt to exceed their authority. Truly meaningful legal recourse must be easily accessed by plant owners who are faced with inappropriate and illegal harassment, interference, intimidation and/or retaliation from ill-meaning agency employees. FSIS Directive 4735.7 was designed to provide owners such protections.  However, we’ve had more than one example of agency coverups of inappropriate agency activities in Montana, even after plant owners utilized their privileges described in Directive 4735.7, which is inadequate. Directive 4735.7 also requires major modifications.

As a new agency is developed, regulations must prohibit its future employees from taking jobs within the industry for six years after departure from the agency. Currently, we are facing a dilemma entitled “Agency Capture,” in which the agency has been captured and controlled by the very industry supposedly being regulated.  

Pillsbury’s original HACCP protocol is indeed science-based, and provides obvious value to any industry. Meat and poultry plants fully compliant with Pillsbury HACCP principles (including a kill step) truly produce consistently safe food, and qualify for deregulation. Plants producing raw meat and poultry cannot produce consistently safe products; thus, do not qualify for agency deregulation. Requiring Pillsbury concepts such as hazard analyses, development of CCPs, utilizing pre-requisite programs, good manufacturing practices, SOPs, etc. is commendable, and should be retained.  

If the meat and poultry plant successfully produces consistently safe products, such plants should qualify for deregulation.  Plants producing fully cooked jerky, ham, precooked chicken, beef and pork, for example, should qualify for deregulation only after validating the safety of their products via substantial microbial testing at every step of their production process.

After qualification, a decreased incidence of ongoing plant microbial test results may be implemented, results of which must be provided to agency personnel in real time.  And, the agency itself must collect a specified number of microbial samples at various stages within the production line, at decreased intervals the frequency of which is predicated on historical lab results.

Meat and poultry plants utilizing kill steps, and whose lab tests are consistently negative for the presence of pathogens, qualify for deregulation. Plants producing raw meat and poultry, such as my plant and ConAgra’s plant in Greeley, Colorado do NOT qualify for deregulation.

 These plants require a much higher degree of regulatory oversight, including a meaningful “hands on” role by FSIS. Admittedly, this would involve two levels of FSIS scrutiny, which would not constitute an impossible burden.  Admittedly, this would create an uncomfortable burden to the agency to embrace a meaningful presence at the largest slaughter plants. We must remind ourselves that FSIS employees are paid via taxpayer dollars to protect public health, not to protect packer profit or promote agency comfort. 

NASA confidently sends astronauts into space with food produced under Pillsbury-style HACCP protocol. Pillsbury-style HACCP is true HACCP,

while FSIS-style HACCP is a bastardized imposter.  FSIS-style HACCP is akin to cobbling together four flat tires, a chassis, a dilapidated motor, a folding lawn chair, and Visqueen for a windshield and calling it a Mercedes.  

We all remember the unfortunate incident when a returning Space Shuttle disintegrated upon re-entering the earth’s atmosphere, showering toxic debris over numerous east Texas counties. This horrific accident resulted in an intensive NASA investigation, scouring every square foot in those east Texas counties looking for clues that could reveal the cause of the accident.  

If FSIS investigators had been in charge of the investigation, the agency would have concluded that the accident had been caused by inadequate air quality control standards in those counties. FSIS would also have required those counties to implement corrective actions to prevent recurrences. I agree, this is absurd!  However, it is no less absurd than the agency’s continued insistence on blaming downstream further processing plants for the presence of E. coli O157:H7 and Salmonella that arrive at their docks (in containers bearing the official USDA Mark of Inspection).   

All microbial sampling protocol must be specifically designed in part to allow tracebacks to the true source of contamination. Whenever possible, samples should be collected from single source products, not commingled. Ground beef samples should be collected from a clean grinder.  

All sampling, regardless of who collects it, must include thorough documentation of all evidence in real time to describe the meat being sampled.  Public health cannot allow any artificial restrictions of evidence compilation such as FSIS has traditionally employed.

Traceback protocol must be fully developed before the new agency takes power, not 13 years later such as FSIS is now attempting.  Because agency sampling is funded by taxpayer dollars, all agency lab results must be posted on the agency’s website in real time, with unrestricted taxpayer access. 

A resurrection of the agency’s previous,15-sample protocol subsequent to the detection of E.coli O157:H7 is essential at all plants, regardless of size. And, these 15 samples must be collected on 15 consecutive days, or over a longer period at small plants that do not grind every day. 

All tests, whether by the agency or the industry, must be completed, that is, to either a confirmed positive or confirmed negative finding. Artificial termination of tests must no longer be countenanced. All documentation of FSIS-collected samples must be jointly signed by the agency inspector and a plant employee at the time of sample collection:  this would deny FSIS the opportunity to falsely charge an innocent plant if the lab test comes back positive, and deny the grinder the opportunity to deny personal responsibility.

Sampling of finished products does have some public health benefits. However, if the sample is collected from unknown sources, or a large variety of sources, the ability to subsequently implement meaningful and targeted corrective actions at the true source are limited. Therefore, testing should primarily be focused as close to the source originating slaughterhouse origin as possible.

Whistleblower protection must be guaranteed for agency employees who blow the whistle on agency corruption.

FSIS-style HACCP has deregulated the largest plants, while hyper-regulating small plants, many out of existence. Much of this is caused by the lack of national standards. A new agency must implement national standards, allowing plants of all sizes to utilize scientific findings in the absence of irrational and ever-changing subjective demands from every new agency official visiting a small plant.

Small plants constitute 93 percent of all USDA-inspected plants, but produce only 10 percent of our domestic meat. Large plants constitute only 7 percent of USDA-inspected plants, but produce 90 percent of our domestic meat supply. If the new agency prefers to NOT inspect small plants, fine!  All funds previously used by FSIS for small plant oversight should then be given to the states to oversee small plant operations.

States are much more efficient that the bloated USDA/FSIS overlapping bureaucracy, as states have fewer levels of wasteful hierarchical administrators. Let’s not allow FSIS to continue its current deception, by which it claims to desire to assist small plants, while simultaneously harassing and intimidating small plants.

For this to work, liberalized interstate shipment rights must be given to state-inspected plants, with no federal oversight, which would sabotage interstate shipment before it commences.

The vast majority of FSIS Field Force with whom I have visited across America fully agree that FSIS desires to shut down small plants. I somewhat disagree. My perception is that FSIS simply desires to be set free from small plants. As such, FSIS could care less if the plants close down or stay in business; it’s just that the agency no longer wants to be responsible for small plants.

I believe the agency would fully embrace the idea of all small plants going under state inspection, or become custom exempt, as long as the agency is relieved of the burden of inspecting small plants.  Think of the budgetary savings that would accrue to the agency.

Anyone who endorses FSIS-style HACCP becomes an unwitting saboteur of public health. 

FSIS will refuse to see the handwriting on the wall (i.e., FSIS-style HACCP is a hoax), until the agency’s back is up against the wall. We’re getting close.

Nixon had his Watergate, Clinton his Monicagate, and FSIS is experiencing its HACCPgate.  However, FSIS can’t fire Archibald Cox.

Force the Source, Don’t Destroy the Destination.

Sleep well tonight. FSIS is.  

Oh what a tangled web we weave,

When at first we intend to deceive.

—————————–

John Munsell now oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

The Food Safety and Inspection Service’s justification for saying I could not lower the temperature inside my processing room to 45 degrees was that I didn’t have a copy of an approved scientific study in my files proving a 45-degree temperature was acceptable. However, if I increased it to 50 degrees, FSIS would find no fault. 

In other words, plant management can’t make any decision to change operations until they can find a scientific study that validates the efficacy of every specific decision.

Attempts to persuade the agency to re-implement National Standards to provide “safe harbors” to plants as they establish meat production protocol have been totally fruitless.

Instead, in the absence of common sense national standards (a benefit of deregulated HACCP), FSIS can badger and intimidate small plants. Mind you, the agency doesn’t provide answers, but merely rejects numerous common sense decisions plants make, only to hagride plant owners to the point that the owners close the doors and walk away to circumvent this senseless scenario.  Please don’t get me wrong here; although the vast majority of inspectors believe the agency desires to close down small plants, I disagree.

My perception is that FSIS could care less if small plants continue to exist. Instead, FSIS wants to be relieved of the responsibility of providing inspection services to small plants. The best way to accomplish this is to torment and harass small plant owners, especially with worry and dread, until the owner gets so exasperated s/he walks away. Another win for public health! No, another win for an agency that only wants to provide deregulated service to the largest plants. Not only would the agency’s payroll budget decrease, but also the agency would no longer have to worry about its thousands of inspectors revealing details of the agency’s failed HACCP theory to the public. Much easier to micro manage a smaller work force.  

A comparison of the relative number of agency enforcement actions at small plants versus large plants is easily seen by comparing the number of Noncompliance Records (NRs) at some large plants versus small plants in 2010. Through a recent Freedom of Information Act request, FSIS provided me the number of NRs at various large plants in the U.S. At the following three companies, I eliminated the “outliers,” that is, the highest and lowest figures, some of which were way above or below the average of the other plants:

Tyson 14 Plants 114 Average

Cargill 7 Plants   71 Average

Smithfield Packing   3 Plants 53 Average

Both National Beef and Seaboard Foods have only three plants each, so I did not eliminate any outliers.

National Beef 3 Plants 87 Average

Seaboard Foods 3 Plants 43 Average

With the exception of Seaboard Farms’ bacon plants, the large plants listed above kill thousands of beef, pork or chicken daily, yet they average only 43 – 114 NRs annually.

The number of NRs issued at two small plants in Montana in 2010 provide us food for thought.  FSIS assessed 158 NRs at Ranchland Packing in Butte and 115 at Stillwater Packing in Columbus.  

In four meatingplace blogs in January through March 2011, former USDA Under-Secretary for food safety Dr. Richard Raymond discussed agency behavior at these two Montana plants, generating a record number of meatingplace responses.  Following Dr. Raymond’s embarrassing revelations, FSIS immediately decreased the number of NRs at these two small Montana plants by over 50 percent. The agency also retroactively rescinded many NRs that had been closed out in 2010 at the two plants.  

Please refer to Part 4 of this narrative, which explained that Nebraska Beef filed suit against FSIS because it had been assessed 58 NRs, which its complaint alleged constituted evidence of the inspectors’ bias. If Nebraska Beef, with 1,100 employees, is justified in filing a bias claim against FSIS because of 53 NRs over four months, should a small plant with only 12 employees which receives 158 NRs in 12 months be likewise justified?

However, FSIS apparently has no concerns over well-deserved litigation potentially stemming from small plants, perhaps because the small plants lack the political clout and financing to challenge the agency. Small plants are much easier enforcement prey.

The volume at these two Montana plants is incredibly small, and their kill floor speed is negligible. These two plants have not invested millions of dollars to determine how they can remove visible fecal material from the kill floor, because the production lines move so slowly workers can readily observe and quickly remove any contaminant.

Likewise, their HACCP Plans lack the multitude of independent third party scientific theories that the biggest plants proudly parade. The kill floors at these two small plants lack the steam pasteurization interventions employed at the high-speed plants, because the small plants don’t need the intervention.

Back to my 50 degree temperature problem with FSIS.  At the time the agency was hassling me on this issue, FSIS just didn’t seem to have copies of any scientific articles available to assist small plant ignoramuses like me. The agency was fully cognizant of a number of temperature-related articles, but wouldn’t divulge them. Much more fun to watch plant owners squirm and sweat blood!

When the agency created the position of Consumer Safety Officers (CSOs), the agency instructed the CSOs to make such scientific demands, but to NOT provide copies of the required scientific articles. How do I know this? Because dozens of agency employees have told me so. Other plant owners related the same sad tale. Admittedly, when the agency morphed CSOs into Enforcement, Investigation and Analysis Officers (EIAOs), the agency did an about-face, and instructed the EIAOs to proactively provide copies of such articles, or at least the links required to access the articles.  

So, for several weeks the agency threatened enforcement actions against me for lowering my processing room temperature five degrees, and I steadfastly resisted to go back up to 50 degrees. For some unknown reason, the agency let this issue suddenly disappear, never to resurrect it again. One of the few battles I won. Perhaps the agency knew that their position on this was so petty, FSIS wanted to avoid a PR debacle if it ever went public.  

Do you perceive now what FSIS-style HACCP had devo
lved to? Instead of inspecting meat production lines, agency personnel were busy beavers inspecting written HACCP Plans, and ensuring that plants had an abundance of bullet-proof scientific articles justifying every decision appearing in the plant’s HACCP Plan.

Who cared if pathogen-laced meat was flowing down the production lines?  FSIS prefered to closely inspect the theoretical bases of all company decisions, dedicating precious time to auditing all company-generated paper flow and its library of scientific articles. 

Who cared about actual meat production lines?  As long as the written HACCP Plan appeared to be in order, FSIS assumed that all meat produced at the plant must be safe.  

A superlative example of how this played out came in the aftermath of a Federal Register Notice issued by FSIS on Oct. 7, 2002.  The notice required all meat plants to reassess their HACCP Plans to determine if E.coli 0157:H7 was a Hazard Likely To Occur.  As a result of our recall, and our experiencing four lab positives for E.coli O157:H7, I had already determined that E.coli O157:H7 was indeed a hazard likely to occur, and had taken numerous steps to address this hazard.  The Minneapolis DO had already dictated these changes during the four months of disputations in early 2002.  

In 2003, FSIS sent their CSOs (Consumer Safety Officials, supposedly the ultimate HACCP experts) into the field to determine if all plants were compliant with the agency’s demand to reassess HACCP Plans to determine if E.coli O157:H7 was a Hazard Likely To Occur. Two CSOs visited my plant from Sept. 15 to 18, 2003, not only to ensure my compliance, but also to review all details of my HACCP Plan.

One of the CSOs was already intensely familiar with my HACCP Plan, because he was the primary agency spokesperson for the Minneapolis District Office (DO) during the four months of negotiations with me in early 2002, the four months during which I was prohibited from grinding under the USDA Mark of Inspection.  

Some incredible agency demands were made of me during the four days the two CSOs were at my plant.

When they arrived, my “raw ground” HACCP Plan had six Critical Control Points — CCPs —  the points in the production line where we could intervene to prevent, eliminate or reduce pathogens to an undetectable level.

This narrative previously referred to consultant Dr. Helmut Blume, who provided services to my plant in 2002 to resolve my problems with the Minneapolis office.  Dr. Blume thought that it was totally unnecessary for me to have six CCPs in my “raw ground” plan, because in his view six CCPs were dramatic overkill. Many others in the industry agreed. 

However, because the Minneapolis DO had “suggested” (in other words, mandated) these six CCPs during our four months from hell, I had quickly implemented them into my HACCP Plan.

When the CSOs visited with me in September 2003, they also agreed that not only should I not have these six CCPs, but also stated that all six should be removed!  For some reason that will never be revealed, the Minneapolis DO did an abrupt about face on my HACCP Plan.  Apparently, science had changed (for the umpteenth time). This scenario again reveals that the agency was noncompliant with its previous promise that plants could write their own HACCP Plans, and that the agency can’t tell plants what must be in their HACCP Plans.

When agency EIAOs and other touring officials tell small plant owners to jump, we ask “how high?” Refusal to play this game enables agency officials to conduct a witch-hunt at the plant, and the agency always wins.

 I stayed late at work on Sept. 17, 2003, and made pencil changes that removed all six CCPs to fully comply with the “suggestions.” Upon their return to my plant the next day, they asked what CCP I then intended to use as a replacement for the six that had been removed.  I replied that I was not aware of any which would be appropriate.  One CSO then suggested that I list Salmonella as a Hazard Likely To Occur, and to control it with temperature.  I complied with his “suggestion,” and I now had but one CCP.   

And please remember that the six CCPs, which were removed, had originally been implemented because of mandates from the Minneapolis DO. Now, 15 months later, at the insistence of the newest agency visitors at my plant, I deleted all six CCPs, and replaced them with one, the details of which were mandated by these two CSOs.  Whatever had happened to the agency promise that each plant could write its own HACCP Plan, and that FSIS couldn’t tell plants what must be in their HACCP Plans?  

At the same time, the two CSOs stated that it was inappropriate of me to list E.coli O157:H7 as a “Hazard Likely To Occur.” I disagreed, stating that my plant had already experienced a recall for E.coli-contaminated meat, and had experienced four adverse lab reports that revealed E.coli O157:H7 at my plant.

I stated that if there was one plant in the country that should have concluded that E.coli O157:H7 was a Hazard Likely To Occur, it was MY plant. The two CSOs disagreed, yet again denying me the right to author my own HACCP Plan.  

Plants across the country already knew that if they disagreed with CSO suggestions, the plants were almost guaranteed to be issued a NOIE (Notice of Intended Enforcement) from the agency. A NOIE is an agency warning to a plant, stating that if the alleged violation was not resolved within 72 hours, the agency could withdraw inspectors, essentially closing the plant. 

Because of this historical fact, I submitted to all “suggestions” from the CSOs, and implemented their demands. Therefore, when the CSOs demanded that it was inappropriate for me to list E.coli O157:H7 as a Hazard Likely To Occur at my plant, I fully complied.    Although I had never experienced a positive sample of Salmonella at my plant, these two CSOs demanded that I must conclude that Salmonella is a Hazard Likely To Occur at my plant.  Conversely, although I had already experienced one E.coli O157:H7 recall and four adverse lab tests for E. coli at my plant, these two CSOs demanded that I no longer list E. coli O157:H7 as a Hazard Likely To Occur.

I have to wonder if this craziness was being dictated from top FSIS officials in D.C., but only the two CSOs can answer that question. Regardless of the source of these conflicting demands, it again shows that FSIS personnel regularly mandate what must be in individual plant’s HACCP Plans, but only at small plants. And, that their mandates are typically inconsistent with and contradictory to previous agency mandates. Science continually evolves!

My wife Kathryn participated in one of these meetings with the two CSOs. Kathryn discussed constantly changing, contradictory and conflicting demands from each new FSIS visitor to my plant, all of whom mandated changes to my HACCP Plan, while criticizing changes I had previously initiated at the demand of previous agency employees.

Exasperated, Kathryn finally asked, “Who is in charge here?”  After a long hesitation, one CSO admitted “Well … no one.” This CSO response reveals a central failure in FSIS-style HACCP:  FSIS lacks consistent standards, energizing each new FSIS visitor to unilaterally require whatever subjective bias s/he has, even though the newest mandate is diametrically opposed to all previous agency requirements. Plants’ decisions must be scientifically supportable, but agency decisions do not.  

During and immediately after this four-day session with these two CSOs, I maintained copious records of all events that transpired during the four days. I hope these records will be sub

poenaed in a future court proceeding, where the agency and their two CSOs can provide their side of the story.  

Another interesting agency action occurred during another CSO visit to my plant on March 13, 2002.  During this visit, as I unlocked the file and removed the HACCP Plan, the FSIS personnel saw a pistol in the file drawer. This pistol is used to shoot buffalo, and I kept it locked up for safe keeping.

The following week, Dr. Daryl Burden came to my plant again, and in his own words, stated that the agency had commenced a “Violence in the Workplace” inquiry against me. I was incredulous, and asked for an explanation. Dr. Burden stated that since I kept the pistol in the same drawer as my HACCP Plan, that agency personnel allegedly had felt intimidated.

The inquiry was concerned that I was subtly implying that if agency personnel asked to view my HACCP Plan, they might be looking down a pistol barrel instead.  I immediately relocated the pistol into another locked file.

Dr. Burden interviewed all pertinent agency field force, who essentially laughed in his face, and said they did not feel threatened in the slightest. Dr. Burden’s response to this alleged Violence in the Workplace inquiry included the following statement on March 22, 2002:

“I have never witnessed anything at Est 7679 which could at all be considered threatening or intimidating by the management, nor have I been able to find any record of such concerns in the past.”

This is but another example of FSIS concocting trumped-up charges against “rebellious” plant owners who attempt to stand up for their rights.  

Ask any small plant owner in America, who will admit that an agency official (CSO, EIAO, Front Line Supervisor, etc.) arrives at their plant, and “suggests” that numerous changes be made in the plant’s HACCP Plan.  Any attempt to object results in agency-sanctioned harassment and retaliation.  Therefore, we’ve all learned to implement whatever the agency mandates/suggests.  

Six weeks later, another agency official arrives, reviews the recently changed HACCP Plan, and requires that the recent changes be rescinded, and replaced with “suggestions” from the newest agency visitor. If the “suggestions” are not implemented, Noncompliance Reports and NOIEs are guaranteed.  So, we implement the “suggestions,” regardless of how frivolous

Subsequently, another agency employee shows up at our door, reviews our HACCP Plan (not the production line), and thoroughly repudiates the most recent agency-mandated changes, and mandates/suggests an alternative protocol. 

And think about it, folks.  As FSIS continues this façade, this shell game of ever-changing HACCP changes (most of which have zero connection to food safety), the agency continues to endorse the right of the large source slaughter plants to ship into commerce intact cuts of meat whose surfaces are liberally laced with E.coli O157:H7.

Remember, FSIS states that intact cuts of meat that are surface-contaminated with E. coli are NOT adulterated. Therefore, even if the agency successfully shutters all small plants, ongoing outbreaks and recurring recalls continue. Well FSIS, whom will you blame this time?  

I implemented HACCP in January 2000, a true believer in HACCP protocol. But as time went on, I witnessed serious discrepancies in the way that FSIS responded to issues in the field.  I slowly came to realize that I was living a lie, but couldn’t put my finger on the true source of the lie. I simply could not identify what was happening right before my eyes, it was so deceptive.

It wasn’t until August of 2009 that I was informed of the origin of the lie:  FSIS-style HACCP is not true HACCP!  Suddenly, all of the agency’s behavior made sense.  I am no longer living the lie.  Just as my understanding the enormous differences of FSIS-style HACCP compared to Pillsbury HACCP has enabled me to connect the dots to explain our ongoing outbreaks, my goal is that this report will enable all Americans to connect the dots revealing the agency’s intentional bastardization of scientific principles.

This shell game has allowed the agency to abdicate its legislative mandate to protect public health, and to use pseudo science as its justification.  

FSIS sowed the seeds of outright deception when it authored its faulty version of HACCP.  Consumers are now reaping repetitive outbreaks caused by the agency’s unscientific policies.   

This agency-sponsored conundrum also reveals the need for effective tracebacks to the source, instead of focusing agency investigations and enforcement actions at the downstream destination plants that unwittingly purchase meat that was previously contaminated with invisible pathogens.

Historical agency actions continue to reveal that the agency overtly prevents tracebacks to the true source of contamination, via intentional obfuscation of source evidence at the time of sample collection. The agency’s insulation of source plants from accountability virtually guarantees ongoing outbreaks and recurring recalls

Here we are, a full 13 years since the largest plants implemented HACCP, and we continue to experience a spate of ongoing outbreaks and recurring recalls.  For consumers’ sakes, FSIS must be forced to remove its head from the sand.

FDA and FSIS jointly hosted a public hearing on Traceback Protocol on Dec. 9 and 10, 2009, meetings which went all day, both days. One statement made by Jerold Mande, the FSIS Deputy Under Secretary of Food Safety, was as follows:

“We [FSIS] often don’t have all the information we need to protect public health.”

Finally, an admission by a high-ranking FSIS official that agency traceback protocol is inadequate. 

Not to be outdone by this two-day joint venture with FDA, FSIS was the sole host of a subsequent Traceback Hearing in D.C. on March 10, 2010.  In stark contrast with the FDA Hearing, this FSIS Hearing was completed in three and a half hours.

One of the audience participants who stepped up to the audience microphone with a statement was Scott Goltry, the vice president for Food Safety and Inspection Services at the American Meat Institute (AMI). While AMI membership is open to meat plants of all sizes, AMI primarily represents the interests of larger plants. One of Mr. Goltry’s comments was as follows:

“Except in the case of high event periods, AMI is unaware if a change to the trace back follow up sample procedure would have a significant improvement to public health.”  

In other words, improving trace back protocol would not benefit consumers. AMI concludes that definitive determinations of the true source of contamination, and agency enforcement actions at the source, would provide no additional benefits for public health purposes.

Instead, let’s just continue to assess full responsibility against the downstream further processors that unwittingly purchase previously contaminated meat, and maintain the agency’s current practice of insulating the source originating slaughter plant from accountability.  

To the agency’s credit, it issued Notice 58-03 on Oct. 8, 2010, entitled “Collecting Supplier Information At The Time Of Sample Collection For Escherichia coli (E. coli) 0157:H7 In Raw Ground Beef Products And Bench Trim.”  Sound familiar?  This is the same protocol that the agency demanded in the afore-mentioned email from FSIS headquarters in Washington, DC, on July 26, 2002, days before NBC News carried my story.

It’s the same pro
tocol which FSIS rescinded two months later, “for legal reasons,” as stated by an agency official. If FSIS utilizes a truly science-based meat inspection system, the agency would have demanded copious source documentation from day one of HACCP’s advent. Even when I had high school and college lab classes 40 plus years ago, we were taught the obvious need to document in real time all evidence to describe the ingredients that went into our lab project.  FSIS disagreed, until Notice 58-10 was released. After numerous embarrassing and painful outbreaks and recalls, FSIS is more willing to document source slaughter evidence.  

Is there a need for tracebacks? Consider this:  between Jan. 1, 2009 and Nov. 30, 2010, FSIS-conducted testing resulted in 64 positives for E. coli O157:H7. Of these 64 positives, 29 were from plants that did not slaughter and used only one source in the tested lot. Nearly 50 percent should have been easily traced to the source, but were not.  FSIS-style HACCP prohibits tracebacks to the true source.  

Tracing back to the true source, and then forcing the true source to implement meaningful corrective actions to prevent recurrences would greatly benefit public health, in spite of opposition from FSIS and AMI.

In fact, the idea of “prevention” is at the top of the priorities shared by the agency’s new Under Secretary for Food Safety, Dr. Elisabeth Hagen, and the agency’s administrator, Al Almanza.  To their credit, they have proactively embraced prevention as a means of promoting public health imperatives.

Theirs is an unpopular and dangerous position, diametrically opposed to the agency’s historical primary focus on “corrective actions” since HACCP’s advent in 1998.  Prior to the current focus on prevention, FSIS has been content to require corrective actions at downstream further processing plants, ignoring the need for prevention at the source.  

FSIS is currently launching a dynamic data analytics system called the Public Health Information System (PHIS), developed as part of the agency’s effort to collect, consolidate and analyze data.  The FSIS website makes the following statements about PHIS:

“It will integrate and automate our paper-based business processes – often found to be inefficient, time-consuming and limiting – into one comprehensive and fully automated data-driven inspection system.  PHIS will significantly improve the way FSIS detects and responds to foodborne hazards.

“PHIS will enable FSIS to respond more quickly when threats are realized.”

Only time will tell if PHIS will reveal when the agency unfairly targets individual plants for unusually high numbers of NRs. If so, the agency’s inappropriate actions against these two small Montana plants would be red flagged for the world to observe. A central issue within PHIS is whether FSIS officials will continue to enjoy carte blanche authority to perform such targeting, or will PHIS require accountability for all agency employees.

One feature being designed into PHIS, in proposal form now, would require inspectors to document onto their laptops source information whenever the inspector collects meat for microbial analysis at USDA labs.  If implemented as proposed, the following data will be documented for the source slaughter provider for the meat being sampled at the time of sample collection:

— Name and Establishment number of supplier

— Establishment Phone Number

— Establishment contact

— Name, Title, Email, and Fax #

— Supplier lot #

— Production dates

— Name of beef components used in implicated products

— Amount of lot

Previous agency data collection efforts have indeed collected statistics, which have not always forced the agency to initiate meaningful enforcement actions, or even beneficial conversations with impacted meat establishments.  An example is the agency’s STEPS system, or “System Tracking E.coli Positive Suppliers.”

Whenever a plant experiences an E. coli O157:H7 positive lab sample, or a recall for E. coli-contaminated meat, FSIS personnel have accumulated a list of all the source slaughter suppliers from which the impacted plant has purchased its products. All these suppliers are entered onto the STEPS data system as a “potential” supplier of the contaminated meat that caused the pathogen problem at the plant in question.

Over time, if one source slaughter provider’s name should reappear many times on STEPS, FSIS could then consider initiating some actions at the slaughter plant, such as a Food Safety Assessment (FSA), or an increased incidence of agency-conducted microbial sampling. 

In a July 2008 STEPS Reporting of “Suppliers Identified 3 or More Times” since FY 02, the highest reporting six plants were as follows, ranked by number of hits:

Nebraska Beef, Ltd. Est 19336 21

Beef Products, Inc. Est 19872 15

Moyer Packing Co. Est 1311 15

Greater Omaha Packing Co. Est 960A 13

Farmland Nat’l Beef Pk. Co. Est 208A 10

Gibbon Packing Est 5511 10

Questions I have which stem from data on this report can only be answered definitively by FSIS bureaucrats in Washington, D.C.  One question is a potential connection between Nebraska Beef’s 21 appearances in STEPS in July 2008, and Nebraska Beef’s two recalls in July and August, 2008, as reported on page 35 of this report.

I’d like to know what types of communications or enforcement actions, if any, were initiated by the agency with or against Nebraska Beef once the company’s name appeared on STEPS 10 times, let alone 21 times.  FSIS cannot claim that the two recalls were the agency’s actions, because the two Recall News Releases both mentioned that the recalls were due to a foodborne illness outbreak that on Aug. 8, 2008 included 31 cases in 12 states and Canada.  

FSIS continues to develop its technology allowing inspectors with laptops to accumulate reams of statistics. The real question that remains to be answered however is agency willingness to respond appropriately when it receives incontr
overtible evidence revealing that a source slaughter plant is shipping meat into commerce that is laced with enteric pathogens.

It appears that STEPS data have not generated meaningful agency response. Will PHIS suffer the same fate?  Will FSIS bureaucrats have the ability to manipulate numbers in the PHIS database?  Or to unilaterally remove discomforting statistics?  In order to maintain the agency’s semi-retirement comfort level, will FSIS be able to discredit embarrassing PHIS entries by inspectors by stating that the entries are but “personal opinion” or “hearsay”?  Will the agency destroy damaging evidence by claiming “the inspector had no right to make that statement”?  Past agency behavior gives us little reason for confidence.

The mere accumulation of damaging data is valueless if FSIS is unwilling to act on it.  

Another question I would pose to FSIS is what authority the agency has to initiate enforcement actions, even when in possession of damaging microbial evidence that proves that a source slaughter plant has shipped into commerce meat laced with enteric pathogens. 

FSIS sold its version of HACCP to the industry with the four promises listed earlier in this series. The agency promised that it would no longer “police” the industry, that it would be forced into a “hands off” non-involvement role, and that it would voluntarily disband its previous “command and control” authority.  

If we believe that FSIS can be held true to these promises, the agency has intentionally eviscerated itself of any meaningful authority in the industry. So, will the agency comply with all its promises, or be noncompliant?  FSIS must publicly decide: is its primary goal to promote agency comfort with the large plants, or to promote and protect public health?  

Many articles have been written this century about the agency’s cozy “revolving door” relationship with the big packers and their national associations. While the two partners continue to share employees, we can’t accuse them of illegal associations, but the conflict of interest is obvious.  

Poking holes in FSIS-style HACCP is easy, as agency misdeeds and inaction have provided us limitless fodder.  More difficult however is clearly defined changes the should be implemented to promote public health concerns.  Part 9 will provide numerous suggestions for long overdue changes.

—————————–

John Munsell now oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

Back in full swing again, authorized to grind under the Mark of Inspection, I questioned the wisdom of my going public, which would fully reveal the multitude of agency misdeeds.

Although my eldest grandchild was but four at the time, I found myself imagining conversations with her on this issue. I defended the position of NOT going public and, in my mind, she argued in favor of my going public. I kept stating (in my mind) “Hannah, I can’t afford to have the agency mad at me; they will use retaliatory tactics.” She would reply, “Grampa, what’s right is right.  What’s more important:  your comfort level with FSIS, or my health?”

This imaginary argument went on for several days, and Hannah always won the argument.  The turning point was when Hannah stated (in my mind) “Grampa, they’re gonna shut you down anyway, it’s just a matter of time. So what do you have to lose?”

Bingo, the light went on! Without Hannah actually saying a word to me, she caused me to do an about face. There’s just something about grandkids.

I knew then that if I remained quiet, and more outbreaks occurred, and innocent children continued to die, I’d have a difficult time ever looking Hannah in the eye. I realized I’d rather lose my business and have my granddaughter’s respect and trust, than remain silent and become a secret accomplice with FSIS.

On Thursday morning, July 18, 2002, I started calling around, speaking to anyone I could find in the media, to tell my story. I knew it would be a hard sell, because who in their right mind would ever believe that FSIS adroitly avoids tracebacks to the source?

The very idea that the agency was not willing to test potentially adulterated meat for E.coli seemed outlandish. Through an unusual set of circumstances, a representative of NBC Nightly News with Tom Brokaw quickly contacted me, somewhat incredulous with my claims.

After a lengthy visit, they asked if I would allow their film crew on my premises, and would I be willing to be interviewed. I agreed, and immediately sent word everywhere that the NBC crew was coming, and to be watching for a future evening news story focused on agency misdeeds at my plant.  

The next agency action was very interesting. Since I immediately announced the upcoming NBC revelation, I had the foreboding fear of immediate agency retaliation. Yet, the agency had become suddenly quiet, which was disconcerting.  Like the lull before the storm.

On Friday, July 26, 2002, the FSIS Office of Field Operations in D.C. sent an email to all of the District Office Managers.  The email referenced “Here is a summary of the procedures that were agreed upon at the conference call earlier this week.”  The operative sentence was the following:

“At the time the [ground meat] sample is taken, the IIC will obtain from the establishment, the name, point of contact, and phone number for the establishments supplying the source materials for the lot of ground beef being sampled.”

I was immediately provided a copy of this by Dr. Daryl Burden, the same courageous agency veterinarian who hand-wrote the letter disclosing Est 969 (ConAgra) as the source of the three positives at my plant. Since my recall, I had been unsuccessfully pressing the agency to document all source evidence at the time of sample collection, but with zero success.  Is it possible that the agency made this procedural change in advance of the embarrassing NBC revelation?  You be the judge.

On Aug. 1, 2002, exactly two weeks after I went public, Tom Brokaw broke the story. The news clip showed the now-infamous letter from Dr. Burden, as well as footage taken at my plant, and an interview with then USDA Under-Secretary Elsa Murano, who stated that agency investigators were sent to ConAgra, but could find no product to test.

Think of it!  Indeed, there was no product remaining at ConAgra from the same date that produced the hot meat at my plant for three consecutive days, because it had already been shipped into commerce!  The appropriate agency action would have been to “suggest” (aka “demand”) a recall of all coarse ground beef from the one-day of production involved.

The very top management at FSIS concluded that no problem existed because they could find no meat at ConAgra from the one-day of production.  The problem was not hot meat at ConAgra, but at multiple locations throughout the country that were performing final grinds on the pathogen-laced meat.

As we know, FSIS closed down my grinder for four months, but ConAgra’s grinder never stopped.  What a difference plant size makes!

One unanticipated result of the NBC revelation was the multiple dozens of unsolicited emails, telephone calls, and letters I received from total strangers throughout the country. Some were other plant owners, but many were FSIS employees:  inspectors and veterinarians, both currently employed and retired.

These folks related similarly scandalous scenarios implemented by FSIS from coast-to-coast.

My next admission is that I had been totally wrong!  During the four months the agency abused me, I wondered why FSIS had targeted my solitary plant for its unethical enforcement actions, thinking my plant had been singled out.

I was quickly informed by total strangers that the agency conducts such witch hunts at small plants across this continent, that my plant was indeed not unique.  Now if one or two strangers had called with such evidence, I’d tend to disbelieve their disturbing stories.  However, all these folks told the same story, lending credibility to their revelations.  

After the July 26 email from FSIS headquarters in Washington D.C. to all DO managers, inspectors commenced documenting evidence that should have been part and parcel of agency HACCP procedures since day one of HACCP, since HACCP is ostensibly based in science.

But, I can see why the agency waited to change this procedure until faced with an embarrassing NBC revelation:  how can FSIS employees document unrestricted evidence after the agency promised to utilize a “hands off” non-involvement role, and would no longer police the industry?

Two inspectors subsequently documented this evidence at my plant, and provided me copies, which I still have. When the Minneapolis DO found out such source evidence was being documented at my plant, E. coli hit the fan!  The DO angrily demanded to know who created this “rogue form” on which source evidence was being compiled at my plant.

Although FSIS headquarters in Washington, D.C. demanded that such evidence be compiled at the time of sample collection, the Minneapolis DO went ballistic when informed that inspectors were indeed documenting such evidence at my plant. The DO preferred to keep its head in the sand.  But the ultimate question here is who is the head of the snake?  Someone from the DO, or from D.C.?

A couple months later, I heard rumblings that the Minneapolis DO was discreetly instructing its inspectors to discontinue documenting source evidence at the time of sample collection.  The issue took on a “hot potato” quality:  no one wanted to discuss it, and evaded any reference to what was happening.

Besides, the inspection force really did not know offi
cial agency policy because t
he agency was not issuing any written statements on this issue, intelligently creating no paper trail.  I wanted to know what was happening behind closed doors at the DO.  

At a joint FSIS/industry meeting in Great Falls, Montana, on Saturday, Oct. 5, 2002, the manager of the Minneapolis DO took his turn responding to industry questions. I described to him the uncertainty faced by his field force, not knowing if they were to document source evidence at the time of sample collection, or wait until lab results were returned.

His reply, which was made in front of the crowd, and no one in the agency has ever attempted to deny, was as follows:

“For legal reasons, the agency has decided that sample evidence is not to be collected until after lab results have been released.” 

The agency did not fear litigation from small plants. In less than two months, the procedural change that benefitted public health had been rescinded. But, we must acknowledge that the NBC Nightly News revelation was now old, dismissed to the archives. The agency was no longer in the media cross hairs, free again to orchestrate intentional obfuscation of the full truth.  

I should explain why source documentation in real time benefits public health. Let’s say a plant like mine (which slaughters and processes) is scheduled for the inspector to collect a sample of ground beef for microbial analysis at a USDA lab.

Let’s say my plant ground meat that originated from my own kill floor, and the USDA lab concludes that it is positive for E. coli O157:H7.  When the adverse lab result is communicated to the agency inspector, who then notifies me, I could falsely claim that the meat emanated from one of my source slaughter providers.

Since several days have now transpired since the sample was collected, the trail of evidence has turned cold, and the inspector has no way of unilaterally validating the accuracy of my claim as to the source of the sampled meat.  Agency-mandated delays in documenting all evidence provide an opportunity for unethical plant operators to intentionally lie about the source of the hot meat.

On the flip side of the coin, when the USDA lab concludes that the sample was contaminated, FSIS assumes the right to accuse the plant of using its own previously contaminated meat, because no records were kept of the true source of the meat at the time of sample collection, even though the meat may have been purchased from an outside supplier.

The agency’s refusal to document all evidence at the time of sample collection creates opportunities for both the agency and the meat plant to make false claims and accusations.  It also intentionally obfuscates evidence that would prove where the meat was contaminated.

Then-Montana Senator Conrad Burns had been intimately involved in pressuring the agency to utilize appropriate actions at my firm in 2002.  Burns called for a Senate Field Hearing in Billings, Montana on Dec. 11, 2002 to discuss “Food Safety Recall Procedures.”

The panelists included William C. Smith, FSIS Assistant Administrator in the agency’s Office of Field Operations (OFO), two others, and me.  OFO has full authority over agency actions in the field, including agency actions against my firm.

During the hearing, I stated that on “the day that a sample is taken, it is my contention that both the inspector and the plant management should work together and fully document all that information.”  Senator Burns then asked Bill Smith for his response. Two of Smith’s responses in the transcript were candidly revealing.  A recorded on page 39 of the transcript, Smith had this response:

“We’d be collecting an awful lot of information when it would be – we could have inspectors doing more important things.”  

More important things than doing what?  My answer:  documenting the full truth. 

On page 40 of the transcript, Smith further explained agency opposition to documenting source evidence at the time of sample collection:

“… because a number of packers would also be very upset about us [FSIS] collecting information on negative findings.”

I suggest to you that collecting evidence of contaminated meat should be the responsibility of FSIS, but the agency disagrees with me. Yes indeed, FSIS is paralyzed with fear of litigation from the big packers if the agency were ever audacious enough to document source evidence about the pathogen levels in meat originating from these big packers.

Now it is easier to understand why the Minneapolis District Office refused to accept my offer of unopened, intact chubs of Coarse Ground Beef for sampling at USDA labs, concerned that “ConAgra would sue us” as previously described.  As such, Smith implied that FSIS is more concerned with placating the big packers, than protecting and promoting public health. 

A most interesting exchange occurred immediately after the closure of this hearing.  My wife Kathryn approached William Smith and stated:

“I just want you to know that what you have done to this man [John Munsell] is absolutely disgraceful. Over and over and over he rewrote his HACCP Plan 14 times, and every time you rejected it.”  

William Smith replied:

“We have a small plant outreach center in Washington, DC, and John should have contacted them to help him with his reassessments.”

My wife responded:

“Yes, and he was told not to contact her, because she is married to you.”

A visibly upset Smith angrily demanded:

“I’d like to know who told you THAT!”

Who is “she,” at the small plant outreach center?  None other than Mary Cutshall, who just happens to be married to William C. Smith.  It is true that at one time I had considered contacting Mary, but an agency employee (who shall remain unnamed) privately confided in me that I should NOT contact Mary because of the obvious conflict of interest, explaining that if I would contact Mary Cutshall for help, she could pass on my comments to her husband.  

Senator Burn’s involvement didn’t end there. During a chance meeting at the Minneapolis airport in December 2003 (one year after the hearing), Burns and I discussed the state of agency activities against my plant. Burns stated that he had recently been at a social gathering, where he had visited with Ann Veneman, who at the time was the USDA Secretary.  Burns brought up the issue of agency behavior at my plant, to which Secretary Veneman replied:

“We mishandled that from day one.”

It’s a shame that one branch of USDA (FSIS) conducts itself so shamelessly that even the USDA Secretary was cognizant of details. Amazingly, the agency has yet to learn its lesson, as FSIS continues to perpetrate similar misdeeds at small plants nationwide, as revealed to me by dozens of agency employees and other plant owners.

This narrative is not focused on agency misbehavior at my plant, but on systemic agency violations of its public trust and abdication of its congressional mandate to inspect meat and protect public health.

FSIS-style HACCP is all about agency comfort and deregulation of the agency’s closest ally, namely, the big packers.  As William Smith testified at the Senate field hearing, a number of packers would be upset if the agency were to collect information on lab results that prove the existence of contaminated meat emanating from the large source slaughter providers.

It is imperative that I state my endorsement of agency field force, both inspectors and veterinarians. These dedicated folks want to do w

hat is right, desiring to document problems in the field, and frequently report sanitation problems to supervisors who are regularly prohibited from initiating meaningful enforcement actions … at the source slaughter plants.

More than one field employee has told me that HACCP has indeed removed command and control from inspectors.  They immediately add that command and control has been effectively transferred to and is alive and well at the District Offices and in Washington, D.C.

As such, agency bureaucrats have effectively eviscerated field force of any authority, having transferred all authority to FSIS headquarters.  Agency lifer bureaucrats have centralized all decision making into headquarters offices, denying online inspection personnel the authority they need when they observe ongoing fecal sanitation problems.

Admittedly, there is an occasional inspector who misuses authority and victimizes plant management. But overall, the agency’s field inspection force is reputable; nevertheless, it has been demoted to an inferior status by intentional agency design, another fatality from the FSIS-style HACCP Hoax.

Another incident also opened my line of communications with dozens of total strangers, resulting from a lawsuit filed on my behalf by the Government Accountability Project (GAP) against FSIS in October 2004.

The lawsuit had two goals:  force FSIS to initiate long-overdue changes in its corrupted HACCP program, and to reimburse my company for financial losses caused by the agency’s misdeeds.

Once the litigation was announced, I again received dozens of unsolicited communications from many total strangers, both from within the industry and from within inspection ranks.  Interestingly, they all described the same story of FSIS insulating the source slaughter plants from accountability nationwide, the agency’s prohibition against its own inspection force to take meaningful actions when witnessing ongoing fecal sanitation problems against the source slaughter plants, and targeting small plants with unjustified enforcement actions.

While plant management and inspectors alike swore me to secrecy, they nevertheless educated me on the ubiquitous nature of the agency’s pervasive departure from common sense meat inspection protocol, while dedicating an inordinate amount of time to monitoring paperwork flow.  

Another result of my going public was the agency’s perception of the value of its protocol that required 15 additional samples subsequent to the detection of E. coli-contaminated meat at meat plants.

You may recall that this valuable scientific tool had conclusively proven the source of adulterated meat both at my plant, and at Galligan in Denver, Colorado, in the first half of 2002.  In fact, the protocol was TOO successful, an embarrassing hot potato for which FSIS wanted to avoid any future recurrences.

So, how did FSIS change or improve this protocol?  Answer:  the protocol was totally rescinded!  FSIS published Notice 11-03 on April 18, 2003, less than one year after ConAgra’s 19.1 million pound recall, and eight months after the NBC revelation. The rescission was quietly published, with no fanfare, in my opinion a furtive attempt to hide this agency misdeed. Part II (A) 6 of Notice 11-03 includes this statement:

“Section VI, E. 2. Of FSIS Directive 10,010.1 is revoked.”

The implications of this are substantial.  When adulterated meat is detected, the agency desires to skillfully avoid accumulation of additional microbial evidence that could result in (should mandate) a successful traceback to a large source slaughter provider.  In order to insulate the large source slaughter plants, the agency disbanded this 15-sample policy that had caused the agency so much grief in early 2002. 

In all fairness, it must be acknowledged that five years later, FSIS reintroduced a subsequent protocol allowing a diminished amount of follow-up sampling.  On Oct. 30, 2008, FSIS issued Notice 79-08 entitled “Multiple Follow-Up Sampling After FSIS Positive Escherichia coli (E.coli) 0157:H7 Results.” 

According to this notice, inspection program personnel are to collect 8 samples for low volume establishments (establishments that produce less than 1,000 pounds per day of product in question), or 16 for all other establishments. Notice 79-08 expired on Nov. 1, 2009, and its provisions have been incorporated into Directive 10,010.1.  The directive allows for additional scheduling of sampling if it is deemed appropriate.  FSIS has not defined what plant conditions would be deemed “appropriate” to justify additional sampling. 

Since FSIS now allows plants to write their own HACCP plans, FSIS has jettisoned its previous national standards that had previously provided a solid foundation from which to establish plant production protocol.

After all, since FSIS now embraces a “hands off” non-involvement role, and cannot police plants, FSIS claims it cannot establish national standards.  However, the agency regularly rejects HACCP Plans because of alleged inadequacies within the plans, without revealing the alleged inadequacy or the solution to the inadequacy.  Under HACCP, each plant can author its own standards, providing it has scientific justification for such decisions.  A problem this creates is that plants utilize commonly accepted scientific findings in writing their HACCP Plans, but FSIS bureaucrats regularly reject the adequacy of the particular scientific study in one plant, while accepting the study in other similar plants.  Let me give you an example.

Prior to HACCP’s advent, FSIS mandated that plants maintain their processing rooms at a 50 degree F temperature or less, to control the growth of bacteria.  If temperatures exceeded 50 degrees, then the plant had to perform a mid-shift cleanup within four hours of the temperature exceeding 50 degrees.

Cold temperatures greatly retard pathogen growth.  So, when I wrote my HACCP Plan, I unilaterally reduced the temperature of my processing room to 45 degrees as a food safety measure.  Some FSIS inspection personnel objected to this change.  For several weeks, I played pure hell with these agency folks, who threatened enforcement actions against me for implementing this common sense improvement in my production procedures.

Furthermore, this agency argument against me contradicts the earlier FSIS promise that plants could write their own HACCP Plans, and the agency can’t tell plants what must be in their HACCP Plans.

I’ll explain next how this crazy situation played itself out.

———————-

John Munsell now oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

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 source

2. Requiring the source to implement corrective actions

3. 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 foll
owing 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 th

ese 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.

————————

John Munsell now oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

On Oct. 12, 2002, Pilgrim’s Pride Corporation, doing business as Wampler Foods Inc., recalled 27.4 million pounds of fresh and frozen ready-to-eat turkey and chicken products potentially contaminated with Listeria monocytogenes.

The recall was prompted by a test of product sample taken by the U.S. Department of Agriculture’s Food Safety and Inspection Service. Subsequent news articles revealed that USDA-style Hazard Analysis and Critical Control Points (HACCP) thwarted the agency’s inspection force from taking meaningful enforcement actions.  The FSIS, along with the Centers for Disease Control and Prevention, linked Pilgrim’s Pride poultry to a Listeria outbreak that caused eight deaths, three miscarriages and 45 more illnesses, mainly in the Northeast. 

FSIS officials stated that Pilgrim’s Pride knew the Listeria bacteria were present at its Pennsylvania poultry plant months before its products were blamed for killing eight people in the summer of 2002.  Vincent Erthal, who was a federal inspector for the night shift at the Wampler plant until September of 2002, said the company had found an “exceedingly high” number of Listeria bacteria in the plant months before the recall. “This should have been avoided,” Erthal told Reuters. “The plant knew they had a problem. They dragged their feet.” 

Erthal also told the Associated Press that he blamed government agricultural inspectors because of their uncertainty over intervention when harmful bacteria were discovered.  A Dec. 11, 2002 New York Times article reported: “But the inspector, Vincent Erthal, said inspection officials had failed to crack down on some of the problems in part because of what he and other critics see as confusion and indecision in a new federal system for regulating the nation’s food companies.”  

Another news report stated that some congressmen were concerned to have learned the plant had conducted its own environmental tests for the deadly bacteria and found positive results but failed to disclose this information to FSIS inspectors at the time of the testing. 

Such statements constitute a disturbing trend. News reports after ConAgra’s recall also revealed confusion within inspection ranks as to what authority the agency had, and companies’ unwillingness to share test results with the agency. 

Then-USDA Undersecretary Elsa Murano said Pilgrim’s Pride employees had routinely tested for Listeria and found “a spike” in July and August for its presence.  However, the company did not share the information with FSIS because federal regulations did not require companies to test for the bacteria.  

A subsequent article in Food Chemical News on Jan. 27, 2003 related how a coalition of public interest groups charged USDA with unfair treatment of an inspector-turned-whistleblower. The article stated in part:

“Vincent Erthal has received treatment by senior agriculture officials that unfairly discredits him, could tend to diminish public interest in his allegations, and consequently, unjustly threatens the integrity of honest public debate, the group wrote in a letter to Agriculture Secretary Ann Veneman.” 

“The letter says that Erthal repeatedly warned his supervisors of conditions at the facility that lead to the largest recall in history, and on two occasions recommended that FSIS management initiate strong enforcement action.”

“The only crime Vince Erthal is guilty of is being a serial truth teller, said Felicia Nestor, food safety coordinator for GAP.  The USDA’s shameful treatment of him sends a chilling warning signal to all those who might have to weigh whether acting in the public’s interest is a career stopper.”

The previously mentioned Dec. 11, 2002, New York Times article also stated:

“Mr. Erthal, 40, who has been a meat inspector for 18 years, said the new rules have a lot of gray areas. He said inspectors were still taught to step in quickly at any sign of direct contamination.  But when it comes to broader sanitation problems, he and others said, many inspectors are waiting longer to intervene out of a sense that it is now the company’s role to deal with those issues unless there are repeated failures.”  (Personal note:  we are continually reminded to “Let HACCP Work.”)

“Rodney Leonard, a former administrator of the inspection service, said the result is a clear ‘don’t ask, don’t tell mandate’ that is causing inspectors to miss red flags all over the place.”  (Personal note:  how can inspectors ask or tell, when the agency aggressively embraces a “hands off” non-involvement role, no longer authorized to police the industry or to utilize its previous command and control authority?  FSIS-style HACCP has many gray areas.)

“Representative Henry A. Waxman, Democrat of California and the ranking minority member on the House Committee on Government Reform, said “I think what we’re seeing is a picture of a department that has abdicated its responsibility to protect the public in the area of food safety.”  

Another New York Times report, dated Oct. 10, 2003, continued to reveal systemic problems within FSIS-style HACCP.  This article focused on ongoing fecal contamination of carcasses at the Shapiro Packing Company in Augusta, Georgia, which has more than 700 employees and slaughters 1,200 or more cattle each day.  The article includes the following statements:

“Government inspectors monitoring the automated processing line at the Shapiro Packing meat plant here over the past three years repeatedly (emphasis added) discovered sides of beef mottled with cattle manure.”

“According to government inspection reports, on more than 50 days from early 2001 until July, inspectors at the Shapiro Packing plant found feces on carcasses moving down the processing line.  Its meat ends up in schools, supermarkets and fast-food restaurants across the country.”

“On 11 days the inspectors at the plant even found the manure on numerous carcasses that had already been through special cleansing washes of hot water and acid.”

“In the last five months of 2002, inspectors found fecal contamination (on carcasses) about every 12 days.”

“This year brought little improvement. Government inspectors found feces on 12 days in the first six months of 2003.  But the documents show that the company’s own employees discovered far more.  In January and May, Shapiro employees found feces on meat about every other day.”  

“The employees, who spoke on the condition of anonymity, said that some inspectors became frustrated that their superiors appeared to ignore problems that they had carefully detailed in documents called noncompliance reports, which are commonly referred to as N.R.’s (Personal note:  This is eerily similar to statements found in USDA’s OIG criticism of FSIS lack of oversight at C
onAgra in 2002.)

What were FSIS responses to the variety of inspector documentations of ongoing fecal contamination of carcasses?  The same New York Times article stated:

“In March, a safety officer visited Shapiro’s slaughterhouse to monitor its E.coli controls.  The officer took no action, even though the documents show that inspectors had already reported fecal and other contamination of meat on 13 days in the first two months of the year.”

“Last November the inspectors also found E.coli O157:H7, a dangerous bacterium spread by cattle waste, in hamburger and stopped a shipment waiting to go to public schools from a Shapiro meat-grinding facility.  Yet the Department of Agriculture delayed more forceful actions and never did more than threaten to shut the packing plant down.”  

Recurring examples of FSIS’ systemic inaction at source slaughter plants, in spite of ongoing production of fecal-contaminated carcasses, have become commonplace.  The agency intentionally relegated itself to the role of a disinterested bystander when it mandated its style of HACCP at all USDA-inspected plants.  

Furthermore, FSIS kept its inspectors in the dark regarding their authority under the new FSIS-style HACCP.  During the mid-late 90s, FSIS officials publicly stated that the agency would train inspectors in HACCP protocol using a “Just in Time” methodology.  As late as 2002 and 2003, inspectors at my plant kept asking me for HACCP answers, admitting that they had received precious little training yet.  

Inspectors nationwide were forced to ask plant management for advice on how HACCP is to work, both for the agency and for the industry.  Lack of inspector training was discussed on page 10 in the December, 2002 edition of Meat Marketing and Technology (MMT), which interviewed Dr. Garry McKee, the new FSIS Administrator.  The discourse went like this:

MMT:  “Some point to the inconsistencies in HACCP interpretation between line inspectors and supervisors as evidence that field personnel haven’t been trained properly.  How do you respond to that?”

McKee:  “Inspector training is a serious issue; I don’t deny that.  More training is scheduled, and one of my top goals is that all inspectors better understand HACCP.”

Interestingly, almost five years after the large plants rolled out HACCP, FSIS had not yet adequately trained its inspectors.  In many cases, the industry was performing the training. 

Six months later, Dr. McKee wrote an article that appeared in the June 2003 edition of Meat Processing. He said:

“One of our top priorities is to cultivate a highly trained and educated workforce. Funding in our FY 2004 budget now before Congress provides specialized food-safety training to inspectors and other food-safety professionals. In addition, FSIS issued a new directive to its employees that will provide FSIS field personnel with greater understanding and knowledge about their role and responsibilities in safeguarding the American food supply. This is the first set of comprehensive instructions given to inspectors since the inception of HACCP in 1997  (emphasis added).

In the mind of FSIS, this is “just in time” training; 1997 to 2003 doesn’t qualify for “just in time.” 

Several months later, Dr. McKee made some interesting comments to a conference of agency supervisors in Nashville, TN, on October 27, 2003.  Various news articles included the following quotes:

 “McKee said he is tired of reading articles that quote inspectors as saying they don’t have the authority to take action against a plant that’s violating its own HACCP plan or FSIS regulations.”

‘Or isn’t it likely that something is amiss in a plant that gets a lot of positives for E. coli O157:H7 and that maybe we should do something about it on a system-wide basis?,’ he asked, referring to the repeated positives at the ConAgra plant.”

“And lately, there have been many illogical and unnecessary failures.”

“As for reaction from the inspectors, Stan Painter, chairman of the National Joint Council of Food Inspection Locals, said, ‘it all sounds good and wonderful that inspectors have all these rights and authority, but that’s not what’s happening.’  Painter said that supervisors ‘think they’re God,’ and that they don’t want to relinquish any authority to underlings who don’t have veterinary degrees. Supervisors think inspectors don’t have the knowledge, skills or ability to make decisions, Painter told Food Chemical News.”

“Painter pointed to the fact that in some plants, inspectors can’t call a fecal failure on their own. They have to wait until their supervisors say, ‘this is fecal material,’ Painter said. If inspectors can’t even call fecal material, what action can they take beyond that?”

One article stated:

“The speech….was starkly honest about FSIS gaffes and was filled with admonitions that the inspection force must be more responsible and accountable.”

The Nov. 11, 2003 edition of USA Today cited this quote from Dr. McKee’s speech:

“Protecting public health is more than filling out forms. It involves taking responsibility, McKee said.”

Dr. McKee’s tenure as FSIS Administrator was short-lived.  My personal perception is that his demand for personal responsibility being more important than filling out forms may have been his agency death knell. FSIS-style HACCP is all about paper work, totally divorced from personal responsibility, which would dictate that recurring instances of fecal-contaminated carcasses should justify agency intervention. FSIS-style HACCP makes no allowance for common sense, or personal responsibility. FSIS-style HACCP also insulates the agency from any accountability, since the deregulated industry can now operate in the relative absence of any meaningful government oversight.  

FSIS has changed some policies that now allow agency access to results of company-conducted testing, found in FSIS Notice 54-03 released on Dec. 16, 2003; in FSIS Notice 39-08 released on June 6, 2008; and in FSIS Directive 5000.2, Rev 2 released on Dec. 4, 2008.  FSIS Notice 58-10, released on Oct. 8, 2010, now requires inspectors to collect supplier information at the time of sample collection.  However, these changes have not dramatically reduced the number of outbreaks and recalls. 

This narrative has quoted media articles revealing inadequate agency oversight at ConAgra, Pilgrims Pride, Nebraska Beef and Shapiro Packing in 2002 and 2003. Both FSIS and the industry initiated changes since 2003, which resulted in a diminution of outbreaks and recalls in 2004, 2005 and 2006.

The year 2007 brought us back to reality, with numerous outbreaks and recalls, which have in fact persisted to the present day. Recalls in 2007 through 2011 are constantly reminding us that FSIS-style HACCP is not the scientific panacea as originally suggested, and direly needs dramatic mid-course corrective action.

Following is an incomplete but interesting list of some of the largest E.coli and Salmonella recalls we’ve experienced during the last five years:

June 6, 2007 United Food Groups 5.7 million lbs E.coli O157:H7

Nov 1, 2007 General Mills 3.3 million lbs (Pizza ) E.coli O157:H7

Nov 3, 2007 Cargill 1,084,384 lbs E.coli O157:H7

Oct 6, 2007 Cargill 845,000 lbs E.coli O157:H7

April 20, 2007 HFX Inc 259,230 lbs E.coli O157:H7

Oct 13, 2007 J & B Meats 173,554 lbs E.coli O157:H7

July 3, 2008 Nebraska Beef 5.3 million lbs E.coli O157:H7

June 25, 2008 The Kroger Co. 1,613,122 lbs E.coli O157:H7

Aug 14, 2008 Nebraska Beef 1.36 million lbs E.coli O157:H7

May 16, 2008 JSM Meat Holdings 345,000 lbs E.coli 0157:H7

January 12, 2008 Rochester Meat Co 188,000 lbs E.coli O157:H7

Aug 6, 2009 Beef Packers 825,769 lbs Salmonella

July 22, 2009 KINGS Soopers 466,236 lbs Salmonella

June 28, 2009 JBS Swift        380,000 lbs E.coli O157:H7

Dec 24, 2009 National Steak 248,000 lbs E.coli O157:H7

May 21, 2009 Valley Meats 95,898 lbs         E.coli O157:H7

Jan 18, 2010 Huntington Meat        864,000 lbs E.coli O157:H7

Feb 12, 2010 Huntington Meat         4.9 million lbs ADULTERATED

(Please see the next paragraph below which describes what is meant by “adulterated” in this unusual situation at Huntington Meat.)

Jan 23, 2010 Danielle International 1,263,754 lbs Salmonella

Aug 6, 2010 Valley Meat Co 1 million lbs E.coli O157:H7

April 21, 2010 Beltex Corp 135,000 lbs E.coli O157:H7

April 1, 2011 Jennie-O Turkey 54,960 lbs        Salmonella

March 22, 2011 Palmyra Bologna Co 23,000 lbs        E.coli O157:H7

March 8, 2011 Creekstone Farms 14,158 lbs        E.coli O157:H7

Feb 5, 2011 American Food 3,170 lbs        E.coli O157:H7

The afore-mentioned Feb. 12, 2010 recall at Huntington Meat Packing was an expansion of its earlier January 18 recall.  The initial recall covered 864,000 lbs of beef products that may have been contaminated with E.coli O157:H7.  Interestingly, the expanded 4.9 million lb recall was not for E.coli, but for the classification “adulterated.”  A news article in the February 15 edition of “Food Production Daily” provides the following interesting data:

“Huntington Meat Packing Inc. has recalled a further 4.9 million pounds of meat that was not processed in line with the company’s HACCP plan over the course of almost a year, said U.S. authorities.”

“The products are adulterated (emphasis added) because the company made the products under insanitary conditions failing to take the steps it had determined were necessary to produce safe products, said an FSIS statement.”

“This evidence shows that the products subject to this recall expansion were produced in a manner that did not follow the establishment’s Hazard Analysis and Critical Control Points (HACCP) plan, it added.”

It is interesting to note that FSIS concluded that since the company did not fully comply with its HACCP Plan, all product produced during the period of noncompliance was “adulterated” over almost a full year. 

Even though FSIS inspection personnel were at the plant every day during the noncompliance time frame, the inspection force did not observe any insanitary conditions during the entire year.  This lack of adequate agency oversight of alleged long-term insanitary conditions at the plant is not reassuring to public health interests.  

The agency’s allegation of insanitary conditions and recurring “adulteration” of products for almost a full year (occurring directly under the agency’s nose) reveals that the primary god FSIS serves is the company’s HACCP Plan, demoting the agency to that of an auditor of paperwork, absent any meaningful oversight of meat production lines. 

This serves as another example that FSIS perceive
s that unsafe food is produced by noncompliance with written HACCP Plans, and not by insanitary meat production lines.

Please note also that Huntington Meat Packing does NOT slaughter, but merely further processes meat purchased from source slaughter providers.  Therefore, since FSIS concludes that all meat Huntington produced during the year of noncompliance is “adulterated,” we must conclude that Huntington purchased previously contaminated meat from its source slaughter providers for almost a full year.

 I am not aware that the agency initiated any enforcement actions against Huntington’s source slaughter providers, but focused all its enforcement actions against Huntington. Not because Huntington introduced adulterants into its meat, but because it did not fully comply with its HACCP Plan. This is a most important distinction, which awkwardly reveals the agency’s misguided focus, gratis FSIS-style HACCP. 

Huntington’s initial recall was for 864,000 lbs of meat possibly adulterated with E.coli O157:H7, which Huntington unwittingly purchased from source slaughter providers.  In the aftermath of the ensuing extension of the expanded 4.9 million pounds of additional meat, did the agency’s intensive investigation ever determine the true slaughterhouse SOURCE of the pathogen?  No.  The source of the E.coli O157:H7 was never determined; therefore, no corrective actions were required at the source, guaranteeing that public health continues to be imperiled.  

The majority of E.coli and Salmonella recalls this century occurred at plants that have been fully compliant with their written HACCP Plans.  If this was not the case, FSIS would have mandated expanded recalls in all cases, justified by the plants’ noncompliance with their HACCP Plans.

Therefore, we must admit that the vast majority of recalls and outbreaks have been caused not by HACCP Plan failures, but because these pesky enteric bacteria continue to circumvent the best of HACCP Plans and furtively escape into the food chain, all caused by sloppy dressing procedures on the kill floor.

Admittedly, since Huntington was caught in the act of intentionally not complying with its written HACCP Plan, the plant is liable for administrative deficiencies and must face agency enforcement actions.  However, the agency’s “suggestion” to recall an additional 4.9 million pounds of meat only resolved the administrative noncompliance, with limited if any benefit for safe food considerations.  But the 4.9 million lb recall expansion certainly provided PR benefits for FSIS.  Who cares if the expanded recall has any benefit for consumers?  

Four of the above recalls are still in the agency’s “Active File,” meaning the recalls have not been completed, which would have allowed the recalls to be retired to the agency’s archives.  The Feb. 12, 2010 recall from Huntington Meat Packing is still active, as is the April 21, 2010 recall from Beltex Corp.  Interestingly, both of these recalls are over 13 months old, but have yet to be closed out.  Both the March 22, 2011 and the April 1, 2011 recalls are likewise still open.  

However, both FSIS and the industry’s biggest packers are in full agreement that consumers are THE ULTIMATE THREAT to food safety, and that consumers must step up to the plate and accept responsibility for these ongoing outbreaks.  This attitude by FSIS and the industry’s biggest players will be described next.

————————

John Munsell now oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

In May 2005, Dr. Gary Acuff, a microbiologist who heads Texas A & M’s animal science department, conducted a closely controlled scientific study on my kill floor. Its purpose was to validate microbial interventions — hot water and lactic acid spray — for the reduction or elimination of enteric pathogens.  

USDA funded the study in an attempt to develop testing technologies viable for small plants to validate the effectiveness of their kill floor interventions. It involved the development of a surrogate isolate green fluorescing protein (GFP), which mimics E. coli O157:H7.  

This indicator organism demonstrated identical thermal and acid resistance to E. coli O157H7.  On two slaughter days at my plant, the neck regions of each side of beef were intentionally inoculated with either a fresh fecal slurry (from my corrals) or fecal slurry containing the GFP E. coli.  Subsequent to inoculation, all carcasses were washed and placed into our chill cooler.  

Test results revealed that the hot water wash alone on our kill floor reduced the bacteria to an undetectable level, constituting a 4 log reduction. I was astonished that although all carcasses were intentionally inoculated with fresh manure from our corrals, as well as with the surrogate GFP isolate, we nevertheless experienced only a 4 log reduction.

Admittedly, I’m no scientist, and I’m greatly surprised that anyone can experience more than a 4-log reduction, let alone a 7-log reduction.

Please note that a hot water wash BY ITSELF reduced all E. coli inoculants to a less-than-detectable level on our kill floor.  Ours is a very small, very slow kill floor, in stark contrast to the fast chain-driven kill floors at the huge slaughter behemoths, which truly need all the interventions known to mankind. 

FSIS simply can’t acknowledge that small plants don’t need the compendium of costly interventions that are absolutely essential at the high-speed plants.  Since small plants do not have all these expensive devices, the agency concludes that small plant owners are not fully committed to food safety.  

Likewise, small plants haven’t hired third-party auditors and PhD scientific experts to independently validate the efficacy of our HACCP Plans, which of course would cost tens or hundreds of thousands of dollars to effectuate.  One central problem within FSIS-style HACCP is that the agency believes a one-size-fits-all HACCP mentality should fit the entire industry.  

FSIS ardently avoids acknowledging that small plants, with snail-paced speeds, effectively prevent and eliminate pathogen-laced carcasses on the kill floor.  FSIS-style HACCP was specifically designed to deregulate the largest plants, and to hyper-regulate small plants.  FSIS is allowed to operate this bifurcated system because the agency is accountable to no one.          

In September 2002, ConAgra officials sold 54 percent of the company to private investors.  The name was changed to Swift and Company at that time.  After the Greeley plant was sold to Swift & Co., did Swift have better lab results?  The Denver Post published an article two months later, on November 17, 2002, entitled “USDA closes Greeley plant.”  One statement in the report was:

“The Denver Post has learned the government had already cited the plant 19 times since late August for allowing meat to become contaminated with feces,” and that “three of those violations occurred in the past week.”

The same Denver Post article on November 17, 2002 included the following statement:

“Swift and Co. spokesman Jim Herlihy defended the plant.  ‘This is a regulatory issue,’ he said.  “It is not a food safety issue.”  

Swift was indeed in a regulatory dilemma with the agency, for ongoing well-deserved reasons. Herlihy conveniently failed to mention that ongoing production of fecal-contaminated carcasses was the cause of this regulatory issue.  At all other plants, when FSIS discovers pathogen-laced meat, the situation is always described as a food safety issue, which Swift attempted to downgrade to a mere “regulatory issue.”  Contrary to Herlihy’s claim, E. coli O157:H7 is indeed a food safety issue, even when it occurs at a Swift plant.

The same Denver Post article also included this statement:

“The USDA pulled about 15 of its inspectors Friday after finding beef carcasses smeared with feces.  Inspectors said they had briefly shut down production several times in the past few weeks because of contamination, each time allowing it to resume when plant officials promised (emphasis added) violations would not recur.”  

FSIS now circumvents initiating enforcement actions based upon an innocuous “promise” that violations would cease.  When the violations continue, well, another promise is all FSIS requires to back off again.  Another premiere example of  “An Abundance of Caution.”  

To better understand how FSIS allowed this conundrum to occur, we must briefly study a document issued by FSIS.  On Feb. 1, 1998, the agency issued Directive 10,010.1 entitled “Microbiological Testing Program For Escherichia coli O157:H7 in Raw Ground Beef.” 

The publication explains that plants could qualify for an exemption from agency sampling of ground beef for E. coli O157:H7, provided that the plant met certain qualifications. One qualification was that the meat plant conduct routine daily testing, and that the plant had not experienced a positive lab test result for the previous six months.   

The fact that FSIS was not collecting ground beef samples at ConAgra in 2002, but that ConAgra was conducting its own testing, reveals that ConAgra qualified for the exemption.  But something doesn’t make sense here:  since ConAgra had to prove that it had zero lab positives for six consecutive months in order to benefit from this exemption, how could ConAgra later have a “continuous problem” as documented by OIG? 

The Greeley Tribune published an article about ConAgra on July 23, 2002, just four days after the expanded recall, which included this statement:

“They [FSIS investigators] found contaminated meat had been processed at the plant on at least 34 days going back to April 12, said Dan Puzo of the inspection service.”  

What happened to the agency’s requirement for six months of zero positives?  

When ConAgra experienced 34 E. coli O157:H7 positives in 100 days, did the company implement corrective actions to prevent recurrences?  If ConAgra did, their corrective actions were woefully inadequate, made possible by the relative absence of any meaningful FSIS oversight.  

The sheer number of subsequent adverse lab results at least leads us to think that corrective actions were NOT initiated.  How could this happen?  Answer:  because of the FSIS deregulated HACCP Hoax, by intentional agency design.

To make matters worse, the OIG investigative report stated:

“From April 12, 2002 through October 21, 2002, OIG noted at least 115 e. coli positives at the ConAgra plant.”  

The agency’s unwillingness to confront the known so
urce of E. coli-contaminated
meat, in a timely fashion, is not allowed under the FSIS-style deregulated HACCP Hoax, which of course is “science-based.”  If FSIS-style HACCP is science-based, I am Darth Vader’s fairy godmother.

Let’s return to Directive 10,010.1 that provided the big packers exemptions from FSIS-conducted sampling & testing. The largest plants implemented HACCP on Jan. 26, 1998.  Ironically, FSIS issued Directive 10,010.1 on Feb. 1, 1998, a mere six days later!  Quick payback.  FSIS used this exemption as a reward to the largest plants for their “cooperation” in voluntarily implementing HACCP.  We must remember that under questioning in the mid-90s, FSIS officials stated that the “scientific basis” of HACCP centered on microbial testing; nevertheless, the agency discontinued testing for all practical purposes at the largest plants six days after HACCP was implemented.  Science itself seemed to be changing.  

Directive 10,010.1’s exemption of qualified big packers from agency-conducted sampling explains why an official from the Minneapolis DO rejected my offer to provide unopened chubs of ConAgra and Cargill coarse ground beef for agency testing. 

Rather than sample the intact chubs, and determine the true source of adulterated meat, the agency elected not to test intact chubs of coarse ground beef for fear of litigation.  This is but another example of FSIS being paralyzed with fear of litigation emanating from a large packer.  

Therefore, FSIS places a higher priority on protecting the agency from litigation than on protecting consumers from unsafe food.  When given a golden opportunity at my plant to conclusively determine the true source of contaminated meat, FSIS opted for the more comfortable alternative, which was to eschew litigation with large source originating plants.

The Federal Meat Inspection Act (FMIA) was passed in 1906, enabling the federal government to oversee the meat industry.  Less than 100 years later, on Jan. 26, 1998, FSIS voluntarily acquiesced its policing authority back to the industry, all in the name of “science.”  While the FMIA was designed to protect consumers and promote public health, FSIS-style HACCP was designed to promote agency comfort, by deregulating the largest slaughter plants.  

Another superlative example of FSIS-style HACCP’s evisceration of agency authority was observed during FSIS attempted actions against Nebraska Beef in January 2003.  According to a Feb. 20, 2003 article in Food Chemical News, FSIS wanted to withdraw inspectors because of Nebraska Beef’s repeated failure to correct and implement changes in its HACCP plan.  Rather than closing the plant in January 2003, an out-of-court agreement was reached between FSIS and Nebraska Beef.  A shocking revelation was made in the Food Chemical News article:

“Steven Cohen, spokesman for FSIS, told Food Chemical News earlier this month that the main reason the agency settled with the company was to eliminate the possibility that the plant could continue to operate under allegedly unsanitary conditions during months of litigation.”

Cohen admitted that even when FSIS inspectors observed ongoing unsanitary conditions at a plant, the agency lacked the authority to pull its inspectors.  At the very least, FSIS knows that litigation is guaranteed if the agency were ever audacious enough to foolishly attempt meaningful enforcement actions against a big packer.  Cohen was precisely correct, and I applaud his honesty.  Since FSIS voluntarily surrendered its previous policing authority, relinquished its historical command and control power, and aggressively embraced a “hands off” non-involvement role, the agency knowingly abdicated its oversight role at the large plants, essentially tying its hands behind its back. 

The agency’s weakness at Nebraska Beef was embarrassing, and the agency had to save face somehow.  Therefore, then-FSIS Administrator Dr. Garry McKee released a statement on Jan. 27, 2003, which attempted to bolster the agency’s PR image.  

The statement referred to the agency’s mandate that Nebraska Beef comply with a series of specific requirements, including:

“The appointment of a full time employee responsible for overall implementation, monitoring, verification, validation, reassessment, recordkeeping, review and maintenance of its Sanitation Performance Standards (SPS), SSOPs and HACCP systems.”

Nebraska Beef, a plant with 1,100 employees, did not have adequately trained HACCP personnel.  In stark contrast, my little plant with 11 full-time employees had four employees who had received official HACCP training in Salt Lake City and Kansas City, all of whom were capable of administering HACCP principles in the absence of the other three.  What a difference plant size makes!

The agency’s legal battles with Nebraska Beef were not yet done.  In a May 8, 2003, article on meatingplace.com, one statement included:

“In two lawsuits filed May 2, Nebraska Beef asked it be absolved of the conditions of the Jan. 24 agreement and alleged USDA’s inspection personnel have, and continue to, treat [Nebraska Beef] in an unfair and biased manner by issuing NRs [written violation notices] for conditions that exist in plaintiff’s plant while plants similar in structure and operations to plaintiff’s plant, in which same conditions also exist, are not issued NRs for the occurrence of those same conditions.”  

The May 7, 2003, edition of the Omaha World-Herald also carried the story, which stated:

“Nebraska Beef Ltd. asked in a lawsuit against the USDA that it no longer be required to abide by the conditions of a settlement it reached with the agency in January.  It filed a second lawsuit against individual inspectors and their supervisors.”

“Since then, Nebraska Beef has received 58 reports of noncompliance of food-safety standards by the USDA.  The company cited the reports as evidence of the inspectors’ bias.

‘They’re trying to send a message to the USDA that some people will fight them every step of the way if they try to enforce the law,’ said (Carol) Tucker Foreman, director of the Consumer Federation of America’s Food Policy Institute, which calls for more regulation of the meat industry.”

The fact that Nebraska Beef did not have a full-time HACCP trained individual on staff is but one example of a large plant with no HACCP trained employees.  I attended an “Advanced HACCP/Self Auditing for Meat and Poultry Plants” Workshop in Los Angeles from July 8-9, 2002, sponsored by the National Meat Association (NMA) and conducted by the HACCP Consulting Group L.L.C.  

The trainer was Robert A. Savage, president of the HACCP Consulting Group, and a highly knowledgeable former FSIS employee.  Savage explained the necessity to sell the HACCP ideal to all employees, and to train several employees at every plant.  As an example, he explained how his company had been hired to provide services to a large poultry plant (he didn’t divulge its name) that had more than1,000 employees.  

The poultry plant had originally sent one employee for official training, who then authored a HACCP Plan and related plans for the poultry plant, but did not train anyone else.  This trained employee then left the company, and no one else at the company knew how the HACCP Plan should operate.  

Ironic, that although large plants with more than 1,000 employees didn’t have employees trained in HACCP, my miniscule plant with 11 employees, four of whom had official training, was so abused by agency officials who had an Alcatraz Axe to grind.  Suffice it to say that the agency’s treatment of small plants is bia
sed. 

Even when large plants have ongoing, recurring problems from fecal-contaminated meat, FSIS acknowledges it is walking on thin ice if it were ever to be stupid enough to attempt any kind of meaningful enforcement actions.  In stark contrast, hell hath no fury like FSIS when contaminated meat is discovered at small, downstream further processing plants. 

One conclusion, albeit temporary, resulting from the agency’s closure of Swift’s Greeley plant was that Swift agreed to slow line speeds to settle the fecal matter issue with the agency.  This event was discussed in a Nov. 26, 2002 article at meatingplace.com.  The article stated that FSIS inspectors closed the plant November 15 following “repeated violations” of the zero tolerance standard for fecal matter on carcasses. 

Why doesn’t FSIS quickly intervene when violations are observed, but instead elects to dilly-dally until repeated violations occur, or 115 positives are documented?  Or, wait for a CDC or local/state epidemiological traceback, which finally forces FSIS into action?  Answer:  FSIS-style deregulated HACCP mandates the agency’s inaction … at large plants.  

At the time of the ConAgra recall, the USDA Under-Secretary for FSIS was Elsa Murano.  The July 25, 2002 World-Herald Bureau discussed the ConAgra recall, and included these quotes from Murano:

“Because ConAgra slaughters 5,000 head of cattle and produces about 800,000 pounds of [boneless] trim daily at the Greeley plant, one or several positive E. coli tests on some days wasn’t cause for alarm.”

“That is not that high a number,” Murano said. 

I suggest to you that FSIS was incorrect when it falsely accused ConAgra of having failures in its HACCP Plan.  Sanitation failures on ConAgra’s kill floor created ongoing problems with fecal-contaminated carcasses.  These fecal noncompliances did NOT emanate from theoretical design failures within its HACCP Plan.  

There is a huge distinction to be made here.   If you remember nothing else from this narrative, it is essential you perceive what is occurring here.  During the hide removal process on ConAgra’s kill floor, ongoing mistakes were being made which were unwittingly depositing fecal material onto beef carcasses, as documented in the OIG report.

I contend that any science-based government agency desiring to remedy this problem would intensively scrutinize all kill floor procedures to determine where the failures were occurring, and fix the problems at the SOURCE, which is the kill floor, not a written HACCP Plan based in theory.  FSIS, with all its highly paid PhDs on staff, disagrees with me.  

FSIS places full faith in written HACCP Plans, which is where the agency focuses its investigative efforts following a recall, an outbreak, or adverse lab results.  

It is imperative to realize that plants with theoretically inadequate HACCP Plans can still produce safe food (the meat industry did so prior to HACCP), while plants with superlative HACCP Plans (remember the 7 log reduction claim?) can consistently produce E. coli O157:H7-contaminated meat.  

ConAgra’s debacle is but one example.  Bottom line:  wholesome meat does NOT require a pretty HACCP Plan, decked out with alleged third-party validations, scientific studies, annual certifications, Certificates of Analysis, ad nauseum.  FSIS disagrees. 

When introducing its perverted style of HACCP, FSIS took a triangular peg and forcefully pounded it into a round hole.  Likewise, FSIS-style HACCP does not fit into raw meat and poultry reality.  

During the last nine years, I have visited with dozens of plant owners who have experienced adverse lab test findings and/or recalls, all of which resulted in investigations by FSIS.  These plant owners unanimously agreed that 98 percent or more of FSIS time dedicated during subsequent investigations was focused on paper flow and written HACCP Plans in the office. 

Typically, less than 2 percent of investigative time was spent in an obligatory, perfunctory zip trip around the meat plant.  At the end of every investigation, the impacted plant was forced to incorporate additional sentences or paragraphs into its HACCP Plan, implement microbial testing on incoming meat, and perform more paper work.  

The rationale behind these changes is that if the impacted plant had previously had such procedures in place, the plant would not have experienced its adverse lab test results or the recall.  As such, the plant’s production of E. coli O157:H7-laced meat was allegedly caused by the plant’s inadvertent failure to include a written statement in its historical HACCP Plan!  

If readers chose to only remember one paragraph from this narrative, let it be this paragraph.  FSIS investigators ardently avoid meaningful inspection of production lines at source originating slaughter plants, implying that production lines are NOT the source of bacterial contamination.  Instead, FSIS claims that unsafe meat is caused by less-than-perfect paper flow, or theoretically incomplete HACCP Plans at downstream further processing establishments.  Such thinking virtually guarantees ongoing outbreaks and recurring recalls. 

The agency’s inability or unwillingness to adequately monitor the meat industry is not confined to ConAgra and Nebraska Beef, but is widespread, as discussed in the next part.

————————–

John Munsell now oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

On June 30, 2002, after my grinder had been shut down for four months, ConAgra’s plant in Greeley, CO, recalled 354,200 pounds of beef products that were potentially contaminated with E. coli O157:H7.

Yes, this is the same plant identified by the Food Safety and Inspection Service’s Dr. Daryl Burden in his March 1, 2002 hand-written letter as the source of the beef ground in my plant. That was the letter that the Minneapolis District Office (DO) cautioned me to never mention again.  The chickens had come home to roost. Even the U.S. Department of Agriculture was incapable of covering up the truth over a prolonged period.  

Out of the ostensible goodness of its heart, the Minneapolis DO expeditiously granted me the right to grind again under inspection, subsequent to the ConAgra recall. This was an unexpected act of gracious altruism on the agency’s part, because in its opinion I had not implemented any meaningful corrective actions in the interim to deserve this reprieve.  

Events that were totally out of my control had intervened to my benefit, and to the benefit of public health.

Please bear with me, because I must provide evidence embarrassing to the agency that reveals exactly why the Minneapolis DO begrudgingly granted me the right to grind again.  On or just prior to Monday, July 1, 2002, the agency’s Number 1 official in Montana, Circuit Supervisor Dr. Grady Skaggs, explained to me three demands mandated by the Minneapolis DO that I must incorporate into my HACCP Plan. If I complied with these three demands, the Minneapolis DO would allow me to grind again. 

My immediate reaction was that the agency had promised the industry that we could write our own HACCP Plans, and that FSIS could not tell plants what must be in our HACCP Plans.  Nevertheless, these three agency demands, which were delivered to me by Dr. Skaggs, mandated that I include sampling for E. coli O157:H7 as a critical control point in my HACCP Plan. 

The mandate also required that my sampling protocol would separate (for sampling purposes) meat from my own kill floor, distinguished from the meat I purchase from outside source slaughter providers. I was agreeable to these agency demands, since compliance with the demands would allow me to grind again. 

But there was a potential deal breaker. I wanted to document for posterity that my willingness to comply would also show that the agency was mandating these changes.  Acknowledgment that these three changes were agency mandates was what the Minneapolis DO wanted to avoid, but what I insisted on.

Therefore, I typed a letter on July 1, 2002, explaining my willingness to comply, but also specifying the mandate behind these changes, and I emailed it to Dr. Nathaniel Clark and Roger Kubera at the Minneapolis District Office.  

How did the DO respond? 

Roger Kubera, Inspection Coordinator at the DO, responded on July 2, 2002 in an email explaining my responsibilities as a plant owner and stating, in part: “I would not see a problem with the proposed recommendations that you are requesting to include in your HACCP plans, along with the supporting documentation.  If this is what you want to do.” (emphasis added) 

Kubera cut to the quick, emphasizing that I must want to make these changes, that is, my suggested changes ostensibly originated from my own voluntarily desires, ignoring that my “desires” were merely a repeat of the mandates originating from the District Office.  So, we were at a stalemate, attempting to document the origin of these ostensibly “voluntary” decisions/mandates.  

The next day, Tuesday July 2, 2002, Kubera called me at 11:11 a.m., on a conference call in which other unidentified DO officials participated as silent witnesses.  To make a 10-minute, 1-sided conversation short, I finally interrupted the monologue and suggested to Kubera that I simply take HIS letter dated the same day (July 2) and write on the bottom “Dear Roger – This is what I want to do.”  

Kubera was agreeable, and said with that statement we would be able to grind again with no restrictions. I wrote the laughable note on his letter, and faxed the letter to him at 11:31 a.m. that day. We were immediately up and running again.

I must add that only minutes earlier, Kubera had visited with Dr. Helmut Blume, the recently retired manager of the agency’s District Office in Salem, OR, who was also acting as my consultant. Neither Dr. Blume nor Kubera has divulged to me the content of their conversation that transpired minutes before the conversation between Kubera, his associates and me.

My assumption is that Dr. Blume must have cautioned Kubera, warning that I was ready to go public, that the ConAgra recall validated my claims of the previous four months, and that the Minneapolis DO was perilously close to being revealed as intentionally ignoring evidence which revealed the ongoing production of contaminated meat, to the detriment of public health.  We may never know.

Anyway, this innocuous, window-dressing conclusion to the four months from hell reveals the nature of the agency’s current meat non-inspection program. My fax to Roger Kubera was a lie. But, a mere lie was the precise missing link allowing me to grind again.

On July 19, 2002, ConAgra’s recall was expanded to include a total of 19.1 million pounds. 

In the weeks that followed the nationwide recall, the Centers for Disease Control and Prevention (CDC) reported more than 45 people in 23 states with illnesses linked to  contaminated ground beef, including one death in Ohio.  The source of the outbreak was traced to ConAgra’s plant.  

However, another incident also helped prompt the recall, an incident that USDA has conveniently kept under wraps. Just prior to ConAgra’s recall, agency testing of ground beef at Galligan Wholesale Meat Company in Denver, another ConAgra customer, also revealed numerous E. coli O157:H7 positives.  

Unlike my plant, Galligan Wholesale Meat does not slaughter, depriving FSIS the opportunity to accuse Galligan of introducing the pathogen. Unless of course, Galligan’s employees also have the same degree of inadequate personal hygiene as the agency falsely alleged against my employees. 

When an initial E. coli O157:H7 positive was detected in a sample collected by FSIS at Galligan, the agency subsequently collected more samples as mandated by the agency’s 15-sample protocol. Galligan continued to grind ConAgra meat for the agency’s follow-up sampling purposes, which in fact became a point of contention.  FSIS claimed that Galligan should present meat originating from other suppliers as well, not limiting sampling strictly to meat emanating from ConAgra. 

However, Galligan management eruditely perceived that ConAgra was the source of the E. coli O157:H7, and to prove their point and protect consumers, they continued to present ConAgra product for sampling.  Their perception was correct, which benefitted the consuming public, because the one true source of adulterated meat was indeed discovered.  Two additional lab positives were detected from samples collected at Galligan; both had come from ConAgra product. 

It i
s imperative to note that FS
IS investigators picked up unopened, intact chubs of ConAgra coarse ground beef at Galligan for sampling and testing at USDA labs. FSIS was unwilling to do this at my plant four months earlier, even though I offered the intact chubs to the agency at no charge. 

Why did FSIS test intact chubs from Galligan, but not from my plant? 

For one thing, FSIS had been receiving criticism and input from Montana’s congressional delegation and numerous individuals on my behalf.  Perhaps the agency finally realized that if it ignored the same evidence at Galligan that it did at my plant, subsequent revelations would provide bad press for the agency. 

And the separate CDC investigation of the outbreak was about to reveal the ugly truth, with or without FSIS cooperation. Against its own desires and policies, FSIS reluctantly tested intact chubs from Galligan, not to protect public health, but to protect the agency’s public image. The tests were positive for E. coli O157:H7.

FSIS did not shut down Galligan’s grinder for four months, like the agency did at my plant.  Why?  Because the CDC  simultaneously and unilaterally (with no assistance from FSIS) traced unrelated adulterated meat back to ConAgra, which incidentally was also the source of the three E. coli O157:H7 positives at Galligan.  

At the time of my recall, there was no public health outbreak, that is, no sicknesses caused by consumers ingesting my ground beef.  Therefore, agency actions at my plant were shielded from public scrutiny and FSIS chose to stick its head in the sand, circumventing a traceback to the true source of my contaminated meat. 

The USDA Recall Press Release 055-2002, dated July 19, 2002 describing ConAgra’s recall included the following statement:

“The Centers for Disease Control (CDC) has documented multiple (emphasis added) cases of illness connected to ConAgra beef that was the subject of the June 30 recall.”  

Therefore, while Galligan was experiencing multiple lab positives in grinding ConAgra meat products, a public health outbreak was simultaneously occurring. 

Furthermore, CDC officials had successfully traced the adulterated meat back to ConAgra, an accomplishment that FSIS had ardently avoided. These incidents at my plant and at Galligan proved that FSIS hid its head in the sand as long as possible, until critical mass evidence was gifted to the agency from other government entities, forcing tardy FSIS enforcement.  

Subsequent news coverage suggested that had FSIS responded appropriately to the evidence compiled at my plant the previous February, USDA should have initiated enforcement actions at ConAgra in February, 2002, and required changes that could have prevented the subsequent dozens of sicknesses, one death, and the 19.1 million pound ground beef recall.  

However, such agency action would be against the very heart of FSIS-style HACCP, which is deregulation. During my four months of hell, numerous FSIS personnel reminded me “Let HACCP Work.” Yes, indeed, HACCP did work at my plant and at Galligan, as both plants successfully detected the presence of E. coli O157:H7 in meat we had purchased from ConAgra. However, HACCP did NOT work at ConAgra.

Congress requested that the USDA Office of Inspector General (OIG) investigate the ConAgra recall. OIG investigators visited my plant for three days in August 2002 to review all my records. OIG also investigated ConAgra, Galligan Wholesale Meat, and FSIS offices in Minneapolis and Denver. One year later, OIG released its investigative report. Several verbatim statements from the OIG report reveal the extent of agency complicity at ConAgra prior to the recall:

“Data was available to both ConAgra and USDA in the period prior to the recall that indicated that E. coli contamination was becoming a continuous problem (emphasis added) at ConAgra.”

“Although animal feces on product was repeatedly (emphasis added) observed during production at ConAgra, USDA took no enforcement action.”  

“USDA did not take enforcement action against ConAgra even though it continued to cite the plant for HACCP violations involving visible (emphasis added) fecal contamination of products.” 

Personal note:  Visible contamination is no longer of concern to FSIS, because visible contamination is accomplished via “organoleptic” (sensory) inspection, which has been outlawed by FSIS-style HACCP. The agency now prefers to audit paper flow, absent visual inspection.

“USDA Inspectors followed policies that effectively limited the documents the inspectors could review and the enforcement actions they were allowed to take.” Personal note:  What else should we expect when the agency voluntarily embraced a “hands off” non-involvement role, while surrendering its previous policing ability and command and control back to the industry?  Consumers are reaping what FSIS has sown.

“USDA should make recall activities more effective by ensuring that ground beef is traceable (emphasis added) from manufacturing to point-of-sale.” 

Personal note: FSIS opposes tracebacks to the big packers, for reasons delineated later in this report, all of which are linked to the agency’s desire for comfort.  

“USDA had reduced its oversight short of what was prudent and necessary for the protection of the consumer.” Personal note:  Sorry folks, but FSIS-style HACCP was NOT designed to protect consumers, but for the benefit of FSIS and the industry’s biggest players.

OIG had previously warned FSIS of the agency’s shortcomings in its implementation of HACCP. On June 22, 2000 (two years before ConAgra’s recall), USDA’s OIG issued a report on FSIS-style HACCP, which included the following statement in its Executive Summary: 

“Because FSIS was uncertain of its HACCP authorities and had not established needed procedures, it had reduced its oversight beyond what was prudent and necessary for the protection of the consumer  (emphasis added).  

Personal note: The fact that OIG’s wording in its 2000 report is identical to the wording in its 2003 report is not coincidental. It constitutes an embarrassing revelation that FSIS ignored OIG’s warning three years earlier. Is OIG ignorant of the fact that FSIS refuses to utilize a “hands on” role, refuses to police the industry, and has jettisoned its previous command and control authority?  Consumer protection had gone the same route as organoleptic inspection … into the dinosaur archives.

Now that we’ve seen how USDA’s own OIG documented problems within FSIS-style HACCP and recurring problems at ConAgra, let’s study ConAgra’s public statements about its compliance with HACCP requirements prior to the company’s 19.1 million pound recall.  ConAgra produced a document entitled “The Strongest Chain of Safety,” which includes the following statements:

“ConAgra Beef Company’s multiple hurdle food safety intervention program has been verified through a series of scientific studies conducted by independent research scientists (emphasis added), which began in 1997. Each successive study demonstrated improved results of the log reduction in E. coli bacteria.” 

“Colorado State University has validated that the ConAgra Beef Company multiple hurdle food safety intervention program reduces pathogenic bacteria by 99.9999 percent.”

“Most importantly, the study [December 1998 NCBA-supported study conducted by Colorado State University] resulted in a 6 log or 99.9999 percent reduction in pathogenic bacteria from the live animal to the chilled carcass, virtually sterilizing the carcass.” (SOURCE

:  Bacon et al. (1999) Colorado State University and National Cattlemen’s Beef Association)

“ConAgra Beef Company’s unparalleled carcass pasteurization program features a series of scientifically proven interventions that result in a 6 log or 99.9999 percent reduction in pathogenic bacteria from live animal to chilled carcass, virtually sterilizing the carcass.” (emphasis added)  

Virtually sterilizes carcasses? This claim does not reconcile itself with the OIG statements that “E. coli contamination was becoming a continuous problem at ConAgra”  or that “Animal feces on product was repeatedly observed during production at ConAgra.” Educated folks would ask why FSIS took no actions in spite of the presence of repeated observations of fecal-contaminated carcasses. Who is in charge? Who do you think?

So much for independent, third-party audits/verifications of the efficacy of a plant’s pathogen intervention system. I would be remiss if I did not explain the tenuous justifications for independent, third-party verifications and audits. Why has our globe been deceived into thinking that public health now pivots on third-party auditors? Frankly, the world has bought into a dumbed-down, deregulated food production system absent meaningful government oversight. Since government regulators now loathe “hands on” oversight of food facilities, the void is now filled with independent, allegedly unbiased third-party auditors. We ignore the fact that any auditor who issues adverse reports will soon have no work in the industry.

These issues were addressed in a Washington Post article by Lena H. Sun on Oct. 22, 2010, entitled “Conflicts of interest mar food producers’ independent inspection.” Some highly revealing quotes from the article include:

“In fact, most food makers, even those with problems, sail through their inspections, said Mansour Samadpour, who owns a food-testing firm that does not perform audits.  ‘I have not seen a single company that has had an outbreak or recall that didn’t have a series of audits with really high scores’, he said.”

“That was the case with Wright County Egg and the Peanut Corp. of America, both linked to recent salmonella-related recalls. Months before the outbreaks, the same inspection firm gave both companies ‘superior’ food-safety ratings, the highest possible for that type of audit.”

“Industry experts say that under the best circumstances the audits can be useful.  But a key failure is that auditors are typically paid by the companies they are inspecting, creating a conflict of interest for inspectors who might fear they will lose business if they don’t give high ratings.”

“At a congressional hearing last month into the outbreak of salmonella illness that has sickened at 1,800 people, staff investigators revealed that Wright County Egg, one of two Iowa farms at the center of the August egg recall, had received a ‘superior’ rating from AIB International two months earlier. AIB also gave a ‘superior’ rating two years ago to Peanut Corp. of America, which federal investigators have accused of knowingly selling peanut products contaminated with salmonella bacteria that sickened hundreds and killed at least nine.”

“Wright County Egg also has said it is addressing conditions identified by FDA inspectors, who found piles of manure, live mice and dead maggots in company barns. AIB did not inspect the barns.” Personal note:  Sounds like FSIS, which focuses primarily on paper flow, not on physical facilities or production lines.

I am tempted to start a new company to provide third-party audits. The name of my independent auditing firm would be “Integrity for Sale, Ltd.” An appropriate motto would be “We’ve got whatever you need.” For the right price, I’ll fill your files with an avalanche of scientific reports that portray your HACCP system to be incapable of contaminating food. If the price is right, I’ll validate whatever you desire. Furthermore, I’ll promise to merely review your paperwork, and refuse to inspect your physical facilities. If you subsequently decide to digress from your plan, disguise your non-compliances via falsification of records, the “hands off” agency will never know.  

The primary need for third-party audits is that FSIS-style HACCP has removed FSIS from its traditional role of inspecting meat. Since FSIS won’t inspect meat, someone has to do it. We can’t expect the industry to fully fill the bill, for obvious reasons. In the absence of any meaningful government oversight, we now rely on third-party auditors to perform the duties previously handled by FSIS. If the agency were to reassume its previous role of inspecting production lines, we would have no need for outside third-party entities.

Likewise, although independent third-party experts concluded that ConAgra’s highly heralded “Multiple Hurdle Pathogen Intervention System” resulted in a 7-log bacterial reduction, the real truth was that “continuous” and “repeated” adulteration of carcasses with visible fecal material was a recurring occurrence at ConAgra.  It is important to note that the USDA OIG report of the ConAgra recall also stated:

“USDA inspectors followed policies that effectively limited the documents the inspectors could review and the enforcement actions they were allowed to take.”  

Therefore, not only did ConAgra operate with continuous production of fecal-contaminated carcasses, but also FSIS itself didn’t know if it had any authority to intervene, gratis FSIS-style HACCP. 

Therefore, FSIS didn’t attempt to force ConAgra to implement corrective actions to prevent continuous and repeated fecal contamination of carcasses.   

I was among the majority of Americans who elected Ronald Reagan, whose espousal of deregulation’s benefits created a paradigm shift in how we viewed the need for government regulation, or the lack thereof.  Pathogens like E. coli O157:H7 revealed gaping holes in Reagan’s overly rosy deregulatory assumptions.  Nevertheless, FSIS remains blindly committed to Reagan’s faulty deregulatory claims.

I am as conservative as they get, so my statements appear to be heinous and heretical.  However, I am now one of thousands of industry insiders (including FSIS field personnel) who have witnessed first-hand how FSIS has intentionally bastardized meat inspection, thereby imperiling consumers.  

FSIS-style HACCP has indeed deregulated the largest plants. The Big Four meat packers currently kill 88 percent of our feedlot-fattened steers and heifers. The risk emanating from these Big Four is substantial, and obvious. Nevertheless, the largest plants are the primary beneficiaries of the agency’s “hands off” non-involvement role. 

Small plants lack clout, are much easier prey, and are the agency’s primary target for enforcement actions.  As long as American consumers unconsciously endorse the agency’s overt deregulation of the largest plants, while hyper-regulating the small plants (which produce very little), ongoing outbreaks are virtually guaranteed.  

Dan Murphy wrote an article for meatingplace entitled “ConAgra Beef to adopt new anti-bacterial rinsing process,” published May 10, 2002, two months before ConAgra’s 19.1 million pound recall. The article described ConAgra’s innovative “Thermal Organic Rinse Process,” referred to as “TOR.”  The article stated that TOR provides “bacteria reduction of 99.99999 percent,” which equates to a 7 log reduction from the live animal to the chilled carcass. Now, what does a 6 log or 7 log reduction mean?

Each log represents a 90 percent decrease in pathogenic bacteria loads. I’ll explain it thi

s way.  Let’s say there are 10 million E. coli bacteria within a specified area on a manure-covered beef hide. How much does this bacteria count diminish with each successive log improvement?

– 10,000,000 initial bacteria load on live animals

– 1,000,000 represents a 1 log reduction

– 100,000 represents a 2 log reduction

– 10,000 represents a 3 log reduction

– 1,000 represents a 4 log reduction

– 100 represents a 5 log reduction

– 10 represents a 6 log reduction

– 1 represents a 7 log reduction

Therefore, ConAgra’s multiple hurdle pathogen intervention system was allegedly independently validated to reduce bacterial load from 10,000,000 on live animals to 1 or less on the chilled carcass. 

Indeed, this would justify the claim that ConAgra’s system “virtually sterilizes carcasses.”  However, OIG’s investigation of ConAgra revealed “continuous problems,” and that “animal feces on product was repeatedly observed during production at ConAgra.”    

FSIS is now primarily focused on auditing company-generated paperwork, and not inspecting meat production lines.  As I stated earlier, FSIS stands for Food Safety Inspection Service.  It should be changed to FSAS, as in Food Safety Auditing Service.  

To claim that FSIS “inspects meat” constitutes a violation of Truth in Advertising laws.  

Referring to ConAgra’s claim to a 7-log reduction in pathogens, USDA’s OIG essentially said the claim was but cowa-BUNG-a balderdash. In other words, leave your manure in the corrals. However, manure did come inside, and cross-contaminated carcasses.  Nevertheless, ConAgra claimed that E. coli O157:H7 on meat was NOT a food safety issue!  

I will discuss that in my next segment. 

——————

John Munsell now oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

Prior to discussing negotiations in the following months between FSIS enforcement officials and my plant, I must describe FSIS meat inspection policies in existence in 2002, which remain to this day. 

After the Jack in the Box E. coli outbreak in 1993 that sickened hundreds of consumers and killed four, FSIS perceived the need to change its meat inspection system.  The old system was incapable of detecting invisible pathogens, such as the E. coli O157:H7 bacteria responsible for the Jack in the Box outbreak. 

The previous system was organoleptic, meaning dependent upon the senses — sight, smell and touch.  Invisible bacteria such as E. coli O157:H7 and Salmonella cannot be detected via sight, smell and touch.  

FSIS was aware of a food production system authored by Pillsbury in the 1960s designed to produce consistently safe food for NASA and the U.S. Army.  Pillsbury named its protocol “Hazard Analysis Critical Control Point,” or HACCP (pronounced “HASS-up”).  

Pillsbury designed HACCP for foods that were subjected to a “kill step,” protocol such as full cooking or irradiation that kills pathogens. Pillsbury built safety into each step of food production, initially validating the safety of each step with substantial microbial testing. 

Subsequently, food plants utilizing Pillsbury-style HACCP have done very little testing, because their products are supposedly consistently safe, in stark contrast to FSIS’s current demand for increased microbial testing.  Why the difference?  The reason is that FSIS-style HACCP is not true HACCP, which this report will reveal. 

Another reason for the difference is that raw meat products produced under FSIS-style HACCP are NOT consistently safe, thereby necessitating increased amounts of microbial testing.  

FSIS proudly proclaimed that FSIS-style HACCP would be “science based,” unlike its previous organoleptic system.  When I questioned what the agency meant by “science based,” the agency stated that sampling for microbiological testing would be required under HACCP. 

Indeed, in the 56 years of my plant’s existence prior to HACCP, neither the agency nor I collected any meat samples for microbial analysis. Upon HACCP’s advent, both the agency and I collected dozens of samples, four of which were positive for E. coli O157:H7 at my plant. Can’t argue with lab results.

FSIS perceived potential industry opposition to HACCP, thus had to dangle carrots in front of the industry to obtain voluntary acceptance of this dramatic change.  During meetings with the industry to roll out USDA-style HACCP, the agency made the following promises:

1. Under HACCP, FSIS would embrace a “hands off” role in meat inspection.  (Personal note: This promise reveals the agency’s desire to not inspect meat production lines.)

2. Under HACCP, FSIS would voluntarily relinquish its previous command-and-control authority.

3. Under HACCP, FSIS would no longer police the industry, the industry was to police itself.  (Personal note:  This would work quite well, if all humans were honest.  What would happen to tax revenues if the IRS allowed us to police ourselves?)

4. Each meat and poultry plant could write its own personalized HACCP Plan, and the agency could not dictate what must be in each HACCP Plan. The hypocrisy behind this promise will be fully explained later in this report.  

Like other plant owners, I was thrilled at the prospect of less FSIS oversight at my plant, having authority to police myself, and to witness FSIS operating in the lack of any policing actions and no command-and-control authority.    

Sugarplums were dancing in my head.  I fully endorsed this deregulated system of non-inspection. Only later did I discover that these promises were apparently intended only for the big plants, while the agency could be fully noncompliant with all four promises at small plants that lack political and economic clout. 

FSIS has used HACCP to deregulate large plants, while hyper-regulating the small plants.  Pretty nifty!  The agency has successfully pulled off the ultimate “bait and switch” – all under the umbrella of pseudoscience.  

FSIS-style HACCP was mandated in the agency’s “Pathogen Reduction:  HACCP Rule” in 1996.  Large plants implemented HACCP on Jan. 26, 1998.  One year later medium-sized plants implemented HACCP, followed by small plants in 2000.

FSIS mandated that every federally inspected meat and poultry plant implement a HACCP Plan, although FSIS-style HACCP had dramatic differences from Pillsbury’s original HACCP system, a well-kept secret. (I was not aware of this until 2009, a full seven years after my recall.)  

Although Pillsbury’s HACCP regimen required the afore-mentioned kill steps, FSIS-style HACCP does not require kill steps. Therefore, plants producing raw meat and poultry designed HACCP Plans with the absence of kill steps. Plants using Pillsbury-style HACCP Plans easily qualify for deregulation, because 1) safety is built into each step of their production system, and 2) their products have been subjected to a kill step. Such plants truly deserve deregulation.  

FSIS-style HACCP simply required plants to author a written HACCP Plan, after which they enjoyed the four agency promises listed above. The assumption was that if a plant merely has a written HACCP Plan, all their raw products would be safe, even though they had NOT been subjected to a kill step.

Central to FSIS-style HACCP is the need to document, document and document, and then document even more:  a classic paper chase. USDA-inspected plants now oversee a daily plethora of HACCP paperwork, inundating them with paper flow, much of which has zero connection to safe food. 

HACCP plans are to say what we do, and then we must do what we say. The only way we can prove that we are doing what our HACCP Plans are saying is to cover our derrière with an abundance of paper, which by the way, can be manipulated via falsification.  FSIS primarily exists to audit the paperwork, not inspect meat.  

Even though a plant’s HACCP Plan is professionally written, it can still produce contaminated meat. FSIS fails to acknowledge that food safety is not determined by paper flow, 3-ring binders with cutsie stickers and labels, and bulging files.  

FSIS wisely fails to acknowledge that sanitary production practices (not paperwork) produce safe meat.  After HACCP’s advent, inspectors dedicated much more time inspecting my paperwork than inspecting my meat production lines. Does that increase your confidence in meat safety? Although FSIS-style HACCP was initially described as a Pathogen Chase, it quickly degenerated into a Paper Chase.

Two common statements from FSIS inspectors and veterinarians since HACCP’s advent have been:

1. FSIS implemented HACCP primarily to lessen the agency’s legal liability in the event of an outbreak, since the agency cannot be held even
partially liable for contaminated meat that FSIS hadn’t inspected in the first place. As such, it has been recommended that FSIS-style HACCP be renamed HASSLE, as in “Hazard Analysis Sorta Scientific Liability Evasion.”

2. Much more importantly, FSIS hierarchy covets COMFORT in its dealings with the influential big packers. Comfort is best accomplished via deregulating the large packers, relegating the agency to a “hands off” non-involvement role.  Since FSIS willingly forfeited its previous policing authority and command-and-control under HACCP, the agency no longer experiences the delicate discomfort involved with attempting enforcement actions against the industry’s high volume elite, who now police themselves.  As such, FSIS used HACCP as a Trojan Horse that was disingenuously labeled  “food safety,” but inside the horse was the agency’s ultimate objective, which was deregulation and agency comfort.  

With this as a background, let’s see how the Minneapolis District Office (DO) responded to the fact that my plant had experienced three consecutive days of adverse lab test results for E.coli O157:H7, perhaps a unique event in the history of the meat industry. 

These adverse lab results provided the agency a golden opportunity to identify the source plant that was grossly noncompliant with E. coli control measures. This incontrovertible evidence would have enabled FSIS to identify the true source, providing justification for swift and effective agency enforcement actions at the source, to the benefit of public health.

Initially, the DO stated that not only did I have a failure in my HACCP Plan, but also that I had multiple failures because of multiple lab positives.  Secondly, the DO stated that I must reassess my HACCP Plan, and implement corrective actions to prevent recurrences.

I quickly reminded them that the copious documentation of source evidence, compiled in real time both by the inspector and by my own staff, provided indisputable evidence that the meat sampled was coarse ground beef I had purchased from one well-documented outside firm.

Furthermore, I reminded them that the documentation also proved that the meat sampled at my plant came from a clean grinder, that is, that no other grinds had been performed earlier in the day that could have potentially deposited residual bacteria which might have caused subsequent grinds to be cross-contaminated. 

I also reminded the DO that the samples on all three days were a single source grind — I did not commingle meats from various sources into one grind. The inspector who collected the three samples documented all of this. Open and shut case. Or so I thought. I never claimed to be brilliant, you know. My dad would never tell me jokes on Saturday nights, as he was afraid I’d laugh in church on Sunday.  

Anyway, as I commenced my HACCP Reassessment, FSIS allowed me to continue to operate, but did not allow me to grind under the USDA Mark of Inspection. My plant could continue operations as before, but could not grind under inspection. Now, try to operate a small meat plant without a grinder!  

I wrote numerous HACCP reassessments, all of which were rejected by the DO as being “inadequate.” These reassessments were time-consuming, costly and all futile. Before this scenario terminated, the DO rejected 14 reassessments, ironic when the industry average is one to two reassessments prior to resumption of normal operations.   

Perhaps FSIS wasn’t as “science-based” as we had been led to believe. Sometimes, “science” can be stranger than fiction.  Please remember that one of the four FSIS pre-HACCP promises was that each plant could write its own HACCP Plan, and that the agency couldn’t tell us what must be in our HACCP Plans. Subsequent historical events continue to reveal to small plants systemic agency misbehavior as shown below. When FSIS officials decide to disagree with entries in HACCP Plans, agency officials automatically resort to the following sophistry:

— “Your HACCP Plan has a failure, and is inadequate.”

— “We can’t tell you what is inadequate, or where the failure is, because it’s your Plan.”

After small plant owners don’t know how to proceed, FSIS concludes:

— “You should consider implementing the following steps.”  

This is allegedly merely a “suggestion,” mind you. Then, after the plant implements the agency’s suggestions, the agency frequently concludes:

— “Your actions are inadequate.”

FSIS-style HACCP is a crazy, convoluted system, which FSIS lifer bureaucrats have ingeniously designed and mastered.

After a few rejections, a remarkable event transpired that has haunted the agency ever since.  An agency veterinarian, Dr. Daryl Burden (now deceased), had previously been assigned to a large plant in the Pacific Northwest, where he observed ongoing pathogen problems.  

When plant management prevented his access to documents, Dr. Burden sent numerous emails to top agency brass in D.C., only to be told he must allow the plant to operate as is, he had lost sight of “The Big Picture,” and reminding him to be a team player.  

Dr. Burden quickly became a liability to the agency because of his dogged documentation of recurring problems, coupled with the agency’s refusal to demand corrective actions at the plant, a benefit of FSIS-style HACCP.  

The agency’s solution was to reassign Dr. Burden. To the agency’s eternal regret, FSIS relocated Dr. Burden to my area, and my plant was one of the first into which he stepped. 

Dr. Burden was immediately instructed by the Minneapolis DO to review my most recent Reassessment, and issue a report to the DO whether I was yet in “full compliance.”  Not only did Dr. Burden state that he personally felt that my most recent Reassessment was adequate, but he went far beyond the assignment given to him and revealed that the source meat originated from another plant.  Dr. Burden’s hand-written statement (I still have the original) included the following statements:

“Review of the three consecutive e.coli O157:H7 failures strongly suggest a common source of the contaminant – coarse ground product of a single identified lot received from Est 969” [ConAgra’s plant in Greeley, CO].  

“I recommend acceptance of Est 7679 [my plant] response and implemented measures, and suggest a follow-up investigation of the source of the product considering the serious public health implications of other possible e.coli O157:H7 adulterated product from the same production lot”.

Inspector Ronald G. Irvine (now retired) hand-wrote “I concur with the above!” signed the document, and dated it 3-1-02, 10:00 a.m.  Dr. Burden asked me to fax the letter to the Minneapolis DO, which I did.  

He left quickly, to drive back to his home in the Black Hills of South Dakota.  Before leaving, he asked me how soon he would be out of cell phone range, as he stated that he knew that the DO would be angrily calling him as soon as they read the fax.  

American consumers, and me in particular, benefitted from Dr. Burden’s courageous act to document the truth in writing.  The absence of this one document would have doomed my advocacy to ruination, as I would have been portrayed as a sore loser, unwilling to accept my well-deserved punishment for allegedly introducing adulterants into ground beef.  

Wouldn’t you know it, early the following week Dr. Burden walked into my office, and sheepishly stated, “The District Office wants me to POLITELY ask you if you would return that letter please.”  I stated “It’s too lat

e, I’ve already made dozens of copies and distributed them in many states,” a true response.  Dr. Burden punched the air with his fist, smiled with great glee, thanked me and walked out.

The succeeding weeks were filled with more conference calls with DO officials.  Of course, calls were typically several of them, versus one of me.  Numerous subsequent HACCP reassessments were provided to the DO, all of which were rejected.  I finally concluded that the agency would never grant me the right to grind again, partly because of the Alcatraz invitation, and because of Dr. Burden’s letter.  

In one telephone discussion with an official at the Minneapolis DO, I made reference to Dr. Burden’s letter.  I was cautioned, “Mr. Munsell, it would be good for you to never again mention that letter.”  The FSIS DO had now resorted to overt suppression of source evidence.  So much for “science.”  

During another telephone conference with Minneapolis DO officials, when I made mention of the letter written and signed by veterinarian Dr. Daryl Burden and inspector Ronald Irvine, DO personnel responded by stating:

— “They were not authorized to make that statement.”

— “That was just their personal opinion.”

So much for documenting evidence in real time.

The November/December, 2003 issue of Mother Jones magazine included a story, which revealed what FSIS did to my plant, and the agency’s lack of oversight of the meat industry.  One of many revealing statements in the article questioned the agency’s desire to document all evidence:

“Never mind that the local federal inspector had seen the beef go straight from the package into a clean grinder – a USDA spokesman called that testimony ‘hearsay.’ “

Confronted with well-documented but embarrassing evidence, agency officials blithely dismissed scientific evidence as “hearsay,” “personal opinion,” and then the all-encompassing solution “the inspector was not allowed to make that statement”.  It is unfortunate when well-meaning FSIS inspectors got in trouble for telling the truth. 

It is also unfortunate that food safety has been entrusted to an agency that prohibits its field force from documenting all evidence without interference from the agency itself.

The Mother Jones article included another revealing quote from an agency official:

“USDA spokesman Steve Cohen also argues that Munsell never proved the source of the initial E. coli contamination and suggests that he ‘got a good deal’ on the ConAgra meat.”

The agency had insinuated that I knowingly purchased E. coli O157:H7-laced meat from ConAgra, simply because I was offered a discounted price. The coarse ground beef was frozen, so I did purchase it at a discounted price compared with fresh coarse ground beef.  But think about it further:  

Steve Cohen’s statement is an official agency admission that FSIS was cognizant that ConAgra was shipping to me coarse ground beef that was adulterated with E. coli O157:H7 pathogens.  (I didn’t know it, but FSIS apparently knew).  So, how did FSIS respond?  It shut down my grinder for four months, while taking no actions at the source-originating slaughter plant.

How did FSIS respond when presented incontrovertible evidence of pathogen-laced meat?  Answer:  It kills the messenger.  And later … consumers.  

During one visit of FSIS enforcement officials to my plant, they stated that improper employee hygiene by my employees might very well have been the cause of the three successive days of E.coli O157:H7 positive samples.  I asked them to explain. 

They stated that employees might have used the rest room, and afterward not washed their hands, potentially leaving human fecal material on their fingers. Then, the employees might have gone directly to the processing room and ground the meat from which the inspector collected a sample, which by then hypothetically would be contaminated with human feces.  

These officials ignored the well-known fact that we don’t grind meat with bare hands, because the meat is so cold. And, before grinding, employees put on cotton gloves (for warmth), and then cover the cotton gloves with plastic gloves that keep the cotton gloves dry and warm. 

I was incredulous at their inane suggestion, and replied that if poor employee hygiene was indeed the source of the problem at my plant, then I must have employees carrying a horrific load of pathogens in their intestines, which would have put them either in the hospital or the morgue. 

I suggested that we review my payroll records, to see who had recently been sick. They declined my offer, and never resurrected this argument again. I bring up this issue to reveal how FSIS may provide theoretical examples of how further processing plants ostensibly introduce pathogens into the food chain.  

Since my recall, numerous other victimized plant owners have told me they’ve been accused of the same.  While E. coli O157:H7 can indeed be introduced at downstream locations, FSIS should at least provide plausible examples.  

My wife Kathy and I drove to Minneapolis to argue our case in person with six DO personnel.  We met on Friday, May 3, 2002 from 2:30 to 6:30 p.m., a 4-hour exercise in futility. Although the agency proffered endless “suggestions,” none of which were viable, such as the idea of my irradiating my entire product line, four particular statements exposed the agency’s bias against small plants:  

1) When I complained about the mountain of boneless trimmings accumulating in my freezer, which I could not grind, the DO folks told me I could legally sell the trim, but could not grind it myself. I was stunned.  FSIS was unknowingly admitting that my kill floor was NOT the source of the E. coli problem. 

2)  One of the DO personnel stated that I had not proven that the sampled meat was not from my own kill floor. So much for the copious documentation compiled by the inspector and my staff during those ill-fated three days of sampling. Essentially, DO personnel assumed the unilateral authority to summarily reject all documentation provided by their own field force, and rewrote history from their remote locations. And secondly, since FSIS still contended that my kill floor was the probable source of the problem, why did the agency authorize me to sell trimmings into commerce that originated from my own kill floor?  

The DO refusal to accept documentation both from its own field force and from me invalidates the agency’s original endorsement of copious documentation, a foundational pillar of HACCP.

It is interesting to note that ConAgra, without any negotiations, quickly issued me a full credit for the three batches of meat I destroyed which was produced on the three consecutive days of E. coli O157:H7 positives — no questions asked.  

Although I took that as ConAgra’s tacit acknowledgement that their coarse ground beef was tainted, the Minneapolis FSIS DO continued its mantra that I had not proven that the bad meat had not originated from my own kill floor. As such, the Minneapolis DO claimed it knew more about the scenario than its own inspector, ConAgra and I knew.

3)  The manager of the Minneapolis DO stated that FSIS Inspector Dan Ellis was not authorized to state that the meat he sampled at my plant in January, 2002 was coarse ground beef I had purchased from an outside source supplier. This agency admission should boil the blood of all meat consumers. FSIS itself states that its
own inspectors are not authorized to admit the origin of contaminated meat. FSIS deprives its employees the right of free speech, or to document unrestricted truth that would benefit public health imperatives. A full revelation of FSIS practices could make vegetarians out of all of us.  

4)  As the meeting progressed, and the subject of multiple reassessments and an equal number of rejections was discussed, while the DO dodged informing me what I needed to do, my wife Kathy finally raised her hands and said with exasperation, “Just tell us what you want us to do.”  The FSIS officials responded, “We can’t tell you what to do, because it’s your own HACCP Plan, and you can write it the way you want to.”  FSIS authorizes plants to write their own individualized HACCP Plans, and then the agency rejects the HACCP Plans as being inadequate.  However, the agency does not have to explain the the inadequacy, nor describe changes necessary (in the agency’s mind) to resolve the alleged inadequacy.  At this point in the meeting, Kathy stated, “Bottom line:  you’re just trying to shut us down.”  The manager of the DO replied “Oh no, Mrs. Munsell, we want to help you get up and running, don’t we?” as he looked to his assistants, all of whom bobbed their heads in agreement. Their actions proved otherwise.

Reminds me of an incident in my home kitchen, decades ago.  As our family ate supper, we noticed that our cat had a mouse, evidenced by the rodent tail protruding from its mouth.  Cats love to torment mice, throwing them in the air, batting them around and finally administering the terminal coup de grâce — an apt description of how FSIS plays with small plants.  

I desperately sought outside assistance. Montana senators Max Baucus and Conrad Burns, and Rep. Denny Rehberg all pleaded on my behalf, to no avail. I joined the National Meat Association (NMA), as I had previously belonged to its predecessor Western States Meat Association, and I perceived that its executive director, Rosemary Mucklow, might provide assistance. I also joined the National Association of Meat Purveyors, and contacted officials within the National Cattlemen Beef Association (NCBA) who might speak some sense to top FSIS officials in D.C. Although officials from these groups made contacts on my behalf, all of my HACCP Reassessments continued to be rejected, with no specific reasons for rejection, nor solutions provided as to what would be required by the agency.

To my relief, NMA and NCBA, at their expense, hired a consultant to work with me to bring this imbroglio to a conclusion. The consultant, Dr. Helmut Blume, was uniquely and preeminently qualified to run the gauntlet on my behalf. He had retired from FSIS only five months earlier, where he had served as the manager of the agency’s District Office in Salem, OR.  He was highly respected both in the industry, and in the agency. 

Dr. Blume flew to Miles City to meet with me, and reviewed my HACCP Plan and related programs.  He personally knew the manager of the Minneapolis DO.  We agreed that Dr. Blume would contact Minneapolis on my behalf, explain that he was a consultant for me, and jointly work with the Minneapolis DO manager to devise specific actions I needed to implement for the resumption of our grinding operations. I suddenly became optimistic.   

Dr. Blume and the Minneapolis DO manager eventually hammered out a number of actions for me to implement to gain the right to resume grinding under USDA inspection auspices. I fully complied with this list, and submitted the finished list to the DO, which rejected it as “inadequate.”  Dr. Helmut Blume was shocked, not understanding how the agreement he had with Minneapolis could be summarily rejected.  Dr. Blume suggested that maybe he couldn’t help me, and perhaps I didn’t want his assistance. I disagreed, stating that he was my only hope.  So, Dr. Blume dejectedly offered to contact the Minneapolis DO again to see if an agreement could be reached.

Well, an agreement was made, and Dr. Blume again provided me an itemized list of requirements mandated by the Minneapolis DO, with which I fully complied.  After reviewing these corrective actions, the DO concluded that the newest measures were “inadequate.”  Damn the evidence!

When I contacted Dr. Blume to inform him of this development, he was incredulous. 

I suggested “perhaps now is the time for me to go public.” I fully anticipated Dr. Blume would forcefully disagree, because he was a HACCP advocate, and was loyal to the agency. Nevertheless, after several surprising seconds of hesitation, he replied “Give [the DO manager] one more chance, then go public”.  

During the four months we couldn’t grind, we lost many customers. Our competitors referred to us as “that E. coli plant.”  We came to discover that our customers slowly developed the misperception, over four long months, that E. coli O157:H7 had become pervasive in our plant, potentially cross-contaminating all our other products as well. One angry customer called, and asked, “When did you start trying to kill your customers?” Sales plummeted. It was an ugly sight to watch our family-owned business atrophy.  

At that time, my family had owned and managed the business for 56 years, and I readily perceived that I would be the shamed captain as our ship sank into the agency’s bottomless abyss. But, as is said, “it is darkest just before the dawn,” I did not see the bright light that was around the corner, one that no authors could ever devise in their wildest imaginations.  

Just when FSIS was about to tip me over, it was upended itself by what I call divine intervention, which I will reveal in the next part…

—————————

John Munsell now oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

Editor’s Note:  This is the first part in a series written by John Munsell of Miles City, MT, who explains how the small meat plant his family owned for 59 years ran afoul of USDA’s meat inspection program. The events he writes about began a decade ago, but remain relevant today.

They say that confession is good for the soul.  I’ve been involved in a series of ugly events since my plant in 2002 recalled 270 pounds of ground beef contaminated with E.coli O157:H7 and now want to admit the embarrassing truth for public review.  

I co-owned and managed a USDA-inspected slaughter and processing plant for 34 years in Miles City, Montana.  When I sold it in 2005, the business had been in my family for 59 years.  The primary reason for its sale was problems stemming from my production of E. coli-laced burger in 2002, the details of which I now confess. 

First, a description of my meat plant may be helpful.  My folks moved to Miles City, Montana the year I was born, 1946, and purchased a very small meat plant.  I was the fourth of 10 children.  After graduating from Montana State University in Bozeman, MT, and stints with Continental Oil and Target Stores, I returned home to take over the plant in 1971. 

Under Dad’s initial guidance, then mine, the plant underwent numerous expansions.  Our marketing area in 1946 was limited to our small hometown of Miles City, which boasts a population of 10,000.  We eventually delivered to numerous communities in eastern Montana.

Our sales to full-line distribution warehouses allowed our products to be shipped across Montana and into adjoining states.  At the peak of our production, we employed 17 people fulltime, and were a substantial member of our rural community.  Besides marketing our products to retail grocery markets, restaurants, and a walk-in retail trade, we also benefitted area ranchers who sold their livestock to us. The highest number of beef we processed in one week was 100 head, so we were a small plant. 

Since 1970, our plant has been USDA-inspected. USDA inspects meat through its Food Safety and Inspection Service (FSIS), initials we will use a lot in this story.

In January 2002, the FSIS inspector at my plant collected a ground beef sample and sent it to the USDA lab for microbial analysis.  It tested positive for E. coli O157:H7. 

FSIS CAUGHT ME. 

When I notified Inspector Dan Ellis (now retired) of the adverse lab results, he immediately replied “John, I wouldn’t worry about it, because it wasn’t your meat I sampled last week.”  His memory was correct, because the meat he had sampled was coarse ground beef I had purchased from an outside source-slaughter provider. 

Inspector Ellis was a prophet, because after my recall, FSIS quickly finished its investigation, and expeditiously allowed me to resume normal operations after I implemented some minor changes.  Interestingly, during a May 3 meeting with FSIS district office personnel, the district office manager told my wife Kathryn and me that inspector Dan Ellis “did not have the right to make that statement.” 

This report will reveal many agency attempts to obstruct the full truth, not only at my plant, but also at small plants nationwide.   

Because ours was a small plant, our kill floor could not provide all the meat required to fill special customer orders throughout the year. For example, a large banquet or reunion might require several hundred pounds of prime rib roasts, sirloin steaks, ground beef patties, etc.  Filling these orders necessitated my purchase of meat from outside source-slaughter providers to supplement meat originating from our own kill floor.

The suggestion to recall the ground beef was made during a telephone conference call with FSIS’s 10-member, multi-disciplinary Recall Committee. The committee members also demanded that I implement corrective actions to prevent recurrences.  

Befuddled, I asked this prestigious committee of the agency’s foremost scientific experts what kind of corrective actions I should take, given that the meat causing the recall had originated from a source slaughter provider, and that I had no control over the wholesomeness of meat arriving at my dock.  The recall committee’s reaction was … SILENCE!  

I exploded with anger and restated the question, but not so tactfully the second time. Finally, one committee member hesitantly suggested that I request a copy of my source slaughter provider’s HACCP Plan, which presumably would describe the steps my provider consistently took to produce safe meat, free of pathogens. 

I complied with their request.  One document provided me by a supplier was a publication entitled “The Strongest Chain of Safety,” portions of which will be quoted and discussed later in my story.  Quickly, FSIS allowed me to again get my plant up and running.  (The term “HACCP” will be fully explained in Part 2 of our story.)

The recall notice, released by USDA, made no reference to the fact that the E.coli O157: H7-contaminated meat originated from my source supplier plant, not from my plant.  I brought up this issue with the agency’s compliance officer, DuWayne Hansen (now retired). 

Compliance officer Hansen stated, “The USDA Legal Department forbids the inspectors to record the origin of the meat.”  When I asked Hansen if he would be willing to document the true origin in his report, he replied, “If I would document the origin of meat being sampled, I’d be walking down the road.”  For the longest time I did not understand the agency’s refusal to document source evidence of pathogen-laced meat. 

Agency policies at that time mandated an additional 15 consecutive days of subsequent sampling after a recall.  In theory, results of these 15 samples would indicate if my production of adulterated meat was merely an isolated incident, or if it might have been a frequent occurrence at my plant.  

I must admit that in the midst of these 15 subsequent samples, meat samples taken at my plant on three consecutive days (Feb. 19, 20 and 21, 2002) all tested positive for E.coli O157:H7.  Talk about a consistently filthy plant!  The batches of meat, which caused these three subsequent E.coli O157:H7 positives, had not been shipped into commerce, because I had quarantined the meat, so no recall was required.

I must also own up to the fact that prior to the January recall, I did not maintain a grinding log, which would have documented all source evidence for every batch of meat put into my grinder. 

Inspector Ellis and I knew the source meat was coarse ground beef from an outside supplier, but we didn’t know from which supplier, production date, batch number, etc.  We purchased coarse ground beef from two suppliers, ConAgra and Cargill.  

Because we didn’t know which suppliers’ meat had been used for the test sample, I offered to provide unopened, intact chubs of coarse ground beef from both suppliers to the FSIS, at no charge, for testing at the USDA lab.  FSIS declined my offer.  

For the longest time, I was flummoxed by the agency’s refusal to test these intact chubs, which would likely have conclusively proved the source of the contaminated meat which had been recalled.  

Nineteen months later, in August of 2003, we were finally informed of the reason for FSIS’s refusal to accept the unopened chubs.  Following a three-day USDA Office of Inspector
General (OIG) investigati
on at my plant, the agency’s top official in Montana, 

Dr. Grady Skaggs (now retired), discussed the issue with me and three other employees.  Dr. Skaggs stated  that the [FSIS] compliance officer wanted to accept my offer of these chubs at no charge, but staff at the Minneapolis office feared that ConAgra would sue. Given an opportunity to conduct tests that may very well have revealed the true source of E. coli-contaminated meat, FSIS decided not to protect public health, but instead to protect the agency from possible litigation by one of the industry’s behemoths.

A statement from FSIS inspector Abe Waldner (now retired), who collected a sample on Friday, Feb. 22, 2002, further explained this dilemma.  Prior to taking the sample, I suggested to him “Instead of taking the sample after it comes out of our grinder, why don’t you simply open up the bag of coarse ground beef from Brand X and take a sample directly from it?  It would be more scientific, and would quickly narrow down the true source of contamination.”  

He replied, “If I did, I would be guilty of ‘conspiring’ with the plant to point blame at the big packer.”  In other words, science-based and unrestricted evidence gathering by inspectors at the time of sample collection is tantamount to conspiracy, and verboten.  Over time, I realized that FSIS’s vaunted “abundance of caution” had morphed into an abandonment of caution when testing for E.coli O157:H7. 

Over time, it became obvious to me that FSIS prohibits documentation of source evidence throughout the sampling/testing process if there is any chance the evidence might possibly implicate one of the industry’s biggest players.  

My 2002 recall taught me the need to fully document all evidence.  Fortunately, we had complete source documentation when the subsequent three consecutive days of positive test results occurred in February 2002.  When FSIS notified me of the three additional positives, I then reviewed my plethora of evidence, and surprisingly discovered that meat for all three positives emanated from the same outside source provider, from the same production date, and the same batch number at the source provider plant. The labels from those three boxes remain secure in a bank safety deposit vault.  

I’m embarrassed to admit my naiveté, but when I discovered that all three positives were from one supplier, with identical production dates and grinder batch numbers, I thought, “Good, now USDA will be forced to change some meat inspection policies.”  

Nine years have passed and agency policies have changed very little.  FSIS has implemented a few minor changes in policies, while adroitly avoiding meaningful changes that would benefit public health and which will be described in a subsequent portion of this story.

The USDA lab notified me on Friday, Feb. 22, 2002 that the sample collected on February 19 tested positive for E.coli O157:H7.  The lab notified me the next day (Saturday) of another positive, and news of the last positive was communicated to me on Sunday.  I was caught red-handed, with no gracious exit.  I fully anticipated a phalanx of FSIS enforcement officials descending upon my plant on Monday but strangely no one appeared and, odder yet, I received no calls from the agency.  

The agency’s disinterest in these three positives seemed a stark contrast to the blitzkrieg of agency officials who immediately confronted me before the recall.  A month later, however, FSIS knew that all meat tested on these three subsequent days originated from an outside plant, and not from my kill floor.  The agency already knew that the inspector involved had likewise documented all this source evidence, which exonerated my plant.  Why is this important?  Let’s start by defining the nature of E.coli O157:H7.

E.coli O157:H7 and Salmonella are classified as “enteric” bacteria.  By definition, enteric bacteria emanate from within animals’ intestines, and by extension are found on manure-covered hides.  Enteric bacteria are different from bacteria such as Listeria, which are environmental.

Because both my plant and my source suppliers slaughter livestock, the E.coli O157:H7 causing these three lab positives could have come from fecal matter from my own kill floor, or from my supplier’s kill floor.  Therefore, to prove the true source of this pathogen, and thusmandate corrective actions at the truly noncompliant source slaughter plant, copious documentation of evidence of the source of meat being sampled at the time of sample collection is readily apparent, and should be required in any science-based sampling protocol. 

Because at the time of my January 2002 recall numerous agency officials immediately visited my plant to peruse production records, I was prepared for an avalanche of furious FSIS inspectors on Monday, February 25, following the three positive test samples.  Strangely, no one came, nor did anyone call.

I smelled a rat. 

In an attempt to shame FSIS into investigating all evidence, I stayed at work late that Monday night, and sent an email (at 8:56 p.m.) to the manager of the FSIS district office in Minneapolis, which has jurisdiction over Montana.  

The email said other processing plants like mine might also have coarse ground beef from the same supplier, with the potential to cause outbreaks.  Referring to these other plants, I concluded “If those plants perform a final grind on that product, and some consumers get sick and/or die, while you and I both know the details spelled out in this email, then … ?  Both of us should share a cell in Alcatraz.”  

Tact is not always my long suit.  

My email did not shame the agency to look at my evidence. FSIS did not send investigators to my plant the following day, Tuesday, Feb. 26, 2002.  So I stayed at work late again, and sent another email to the Minneapolis district office at 7:35 p.m., repeating my invitation to visit my plant to obtain all evidence.  

Finally, perhaps because the manager of the district office loathed the idea of sharing a cell with me at Alcatraz, the agency sent personnel to my plant on Wednesday.  In retrospect, I wonder if my suggestion that the district office manager should be incarcerated at Alcatraz earned me the eternal hatred of the agency, a bitterness driving all the agency’s subsequent machinations against me.  

Agency investigators arrived in force on Wednesday morning, Feb. 27, 2002, and spent several days reviewing my records.  FSIS compliance officer DuWayne Hansen provided me a signed request, officially asking that I divulge the name of the meat plant which supplied me the coarse ground beef which had tested positive on three consecutive days the previous week. 

I was ecstatic to have the legal right to provide the name of the plant, the date of production, and the grinder batch number to Hansen.  Why did Hansen give me a signed request?  Shouldn’t FSIS have the authority to DEMAND all evidence?  There is an embarrassing reason for this.  In my previously mentioned email to the manager of the Minneapolis district office on Monday, February 25, I made the following statements:

“Since the mere documentation of the origin of trimmings is illegal (I presume) for your inspectors, my release of the same information would also be illegal.  I want to fully participate with your staff in addressing the origin of this contaminated meat, but I also know that if I release the information, USDA’s legal staff will have my butt in court the next day.  Dr. Clark, I want to cooperate with you 100% in this issue, but the USDA legal staff
prevents it.”

Bottom line:  before I release to you the information (and I want to), I require signed documentation from the USDA requesting this information, and stating it is legal for me to do so.  I’m not gonna sit in jail in return for exposing the source of contaminated meat.”

Armed with all this data, the FSIS officials then retreated to the comfortable confines of the Minneapolis district office to determine what actions to orchestrate against this miniscule plant in southeast Montana.  The imbroglio that followed is scandalous, and will be revealed in the second part of my story.

——————

John Munsell now oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

USDA’s two legal losses stemming from its actions at Supreme Beef (SB) in late 1999 should have exposed a fatal flaw in USDA-Style HACCP, causing the agency to revise its allegedly “science based” meat inspection system.

USDA withdrew inspectors from Supreme Beef subsequent to the company’s failure in 3 consecutive Salmonella test sets.  Supreme Beef eventually won the legal battle, but lost the war, as it experienced bankruptcy.  Therefore, USDA won the war, but forgot the lessons provided by the battle.  Two superlative sources describing the findings from the U.S. District Court for the Northern District of Texas can be found at:

http://biotech.law.Lsu.edu/cases/food/supreme_Beef_Processors_v_DOA_CA.htm

http://laws.lp.findlaw.com/5th/0011008cv0.html

Before I quote from some of these legal conclusions, let me briefly explain what I consider to be the agency’s primary failure of the Salmonella Performance Standards.  Supreme Beef (SB) did not slaughter, but merely purchased meat from source slaughter providers.  When this meat was ground at SB, and tested, the incidence of Salmonella ranged from 20.8 percent to 47 percent, clearly a hazard to public health.  To save face, USDA/FSIS withdrew inspectors from SB.

We must remember that Salmonella is an “enteric” bacterium, which by strict definition means the bacteria emanates from within animals’ intestines, and by extension flourish on manure-covered hides, both of which are found in slaughter plants, but not at downstream further processing plants such as SB.

FSIS must realize by now that its closure of SB has NOT benefitted public health, as proven by the plethora of ongoing outbreaks and recurring recalls that have become a common occurrence in contemporary America.  Why?  Because FSIS focuses its enforcement actions (actually RE-actions) almost exclusively at the downstream DESTINATION facilities, instead of at the source slaughter providers.  This intentional agency oversight is designed to facilitate comfort at the agency, which has degenerated into a semi-retirement role at the industry’s biggest plants, gratis USDA-style HACCP.

When FSIS introduced its version of HACCP, almost no one realized the agency had dramatically changed Pillsbury-style HACCP into a perverted imposter, while maintaining the HACCP name.  Consumers continue to pay the price for this intentional bait and switch.  While introducing USDA-style HACCP, the agency promised that its role under HACCP would include:

1.The agency would assume a “hands off” role.

2.The agency would no longer police the industry, but the industry would police itself.

3.The agency would disband its previous command and control authority.

4.Each plant would write its own HACCP Plan, and the agency can’t tell the plant what must be in its HACCP Plan.

In retrospect, FSIS has been fully compliant with the above four promises … but only at the largest industry giants.  In sharp contrast, FSIS regularly ignores these promises at small plants, which are far easier enforcement prey.

In a Frontline TV program entitled “Modern Meat,” which aired on April 18, 2002, Elsa Murano stated:  “The HACCP system does not give the plants any authority.  Responsibility.  The authority is ours.  We are the ones with authority.  We shut down plants all the time.  Um, last year alone we took about 200 enforcement actions, uh, in plants in the United States.  So, we very much have the authority to do that.  Um, our inspectors have the authority to do … to follow the regulations and to enforce them on a daily basis.”

Plants which are closing are small plants, not the industry’s giants.  It appears as though the plants the agency is shutting down are the wrong plants.  If small, downstream further processing plants are the problem, and FSIS is aggressively shuttering those noncompliant small plants, why do we continue to experience outbreaks and recalls?

Supreme Beef purchased all its meat from source slaughter providers.  All this meat arrived at SB marked with the official USDA Mark of Inspection, which states “USDA Inspected and Passed.”  Indeed, this means that the agency intentionally allows the source slaughter plants to ship into commerce meat that is laced with Salmonella.  When the Salmonella is detected at downstream further processing plants, the agency responds by unleashing its full enforcement fury at the victimized downstream plant, while insulating the source slaughter plant from accountability.  FSIS is fully cognizant of this intentional oversight, and it cost the agency the SB litigation.  Since the agency has failed to implement meaningful changes in its HACCP regulations, this same scenario continues to play itself out in agency/plant relations, and consumers continue to be sickened (some die).

FSIS displays the same short-sightedness with E.coli 0157:H7.  The agency allows source slaughter plants to ship into commerce intact cuts of meat that are surface-contaminated with E.coli 0157:H7.  FSIS blithely states that such E.coli are NOT adulterants.  But when the destination facility further processes the intact cuts, the heretofore harmless bacteria supernaturally morph into killer pathogens, then are classified by FSIS as “adulterants.”  Sometimes science is stranger than fiction.

Some of the more pertinent quotes from the District Court legal rulings include the following:

From paragraph 19:  47 percent of agency samples collected at SB were positive for Salmonella.

From paragraph 20:  In subsequent FSIS sampling, 20.8 percent of the tests were positive for Salmonella.  Supreme Beef countered that only 7.5 percent of their tests, conducted on companion parallel samples, were positive for Salmonella.  “Only” 7.5 percent!  That’s fine, as long as my family doesn’t eat the 7.5 percent.

From paragraph 45:  “The district court agreed with Supreme and reasoned that because the USDA’s performance standards and Salmonella tests do not necessarily evaluate the conditions of a meat processor’s establishment, they cannot serve as the basis for finding a plant’s meat adulterated under Section 601 (m) (4).  The district court therefore held that the examination of a plant’s end product is distinct from conditions within the plant.”

From paragraph 46:  “Since we are persuaded that the Salmonella performance standard improperly regulates the Salmonella levels of incoming meat (emphasis added) and that Salmonella cross-contamination cannot product may be rendered injurious to health, we conclude that the Salmonella performance standard falls outside of the ambit of Section 601 (m) (4).”

From paragraph 49:  “The use of the word ‘rendered’ in the statute indicates that a deleterious change in the product must occur while it is being ‘prepared, packed or held’ owing to insanitary conditions.”

The entire report is fascinating reading, and continues to emphasize that the agency inappropriately focused on SB’s production of finished product containing Salmonella, totally ignoring the fact that the Salmonella was arriving on incoming loads of meat, coupled with the fact that FSIS did not prove that SB’s plant was insanitary.  Today, in 2010, FSIS continues to place an inappropriate focus on finished product testing, virtually dismissing the evidence that Salmonella contamination of meat occurs at the source originating slaughter plant, NOT at the downstream further processing establishment.

On page 19 of the National Provisioner dated January 2002, an ad by Surebeam included the following statement:  “A performance standard is valid only if it measures the performance of the establishment itself … Microbiological testing, including pathogen testing, may be used as an indicator of an establishment’s performance, but it is only one factor to be considered in judging performance”.  FSIS has yet to learn this valuable lesson.

The July 10, 2000 edition of Food Chemical News, discussing the SB litigation, stated that:  “In a landmark court ruling in May, the US District Court for the Northern District of Texas prohibited USDA from concluding that grinding plants are insanitary or that their products are adulterated based on Salmonella test results (Supreme Beef Processors Inc. v. USDA).  Nevertheless, Supreme says, [FSIS Administrator Tom] Billy said in a recent sworn statement that a facility which fails to control and prevent or reduce pathogens is operating under insanitary conditions, and that Supreme’s failure to control pathogens could result in product that is unwholesome, unfit for human consumption, and injurious to health.  The company [SB] argues that those comments show that Billy and the agency are ignoring the judge’s decision in the case and could take extreme action against the company based upon the government’s continued belief that Supreme Beef’s plant is insanitary based solely on the test results (emphasis added).”

Personal note:  This again reveals that the agency quietly endorses the right of large source originating slaughter plants to ship pathogens into commerce, and that the sole responsibility to (a) detect and (b) remove the pathogens rests upon the downstream further processing facility.  Interestingly, neither the agency nor the source slaughter plant was capable of (a) detecting and (b) removing the pathogens at the SOURCE.  Apparently, downstream plants have a divine ability to detect these invisible pathogens, and if they don’t, the full fury of FSIS’ enforcement actions descends upon these allegedly negligent downstream plants.  Nothing has changed in the agency’s perception of reality during the 10 years subsequent to the FSIS/Supreme Beef fiasco.

The question remains whether the agency has authority to implement enforcement actions, including removal of inspectors, when insanitary conditions are observed at plants.  An article in the Feb. 20, 2003 Food Chemical News reported on a settlement between USDA and Nebraska Beef, in which a federal judge stopped the agency from shuttering the Omaha, NB plant by issuing a temporary restraining order.  The article stated:  “USDA wanted to close the plant because of its repeated failure to correct and implement changes in its HACCP plan.  In September and December of 2002, the department had twice suspended operations at the facility.  Steven Cohen, spokesman for FSIS, told Food Chemical News earlier this month that the main reason the agency settled with the company was to eliminate the possibility that the plant could continue to operate under allegedly unsanitary conditions during months of litigation” (emphasis added).

Finally, the truth from an agency official:  FSIS lacks the ability to shutter a plant, well, at least a larger plant.

Subsequent to ConAgra’s 19.1 million lb. recall of meat potentially contaminated with E.coli in June, 2002, USDA’s Office of Inspector General (OIG) conducted a thorough investigation.  Some verbatim statements from OIG’s report 1 year later included the following:

“Data was available to both ConAgra and USDA in the period prior to the recall that indicated that E.coli contamination was becoming a continuous (emphasis added) problem at ConAgra”

“Although animal feces on product was repeatedly (emphasis added) observed during production at ConAgra, USDA took no enforcement action.”

“Although inspectors at ConAgra raised concern to their supervisors regarding the increasing level of fecal contamination and positive testing results, we (OIG) could find no evidence that USDA managers responded to the concerns raised.  Supervisors were not always responsive to the inspectors’ concerns relating to increasing levels of fecal contamination.”

These statements reveal the fact that FSIS lacked the ability to implement meaningful enforcement actions, even though it observed continuous production of fecal-contaminated carcasses at ConAgra.  When one branch of USDA (OIG) publicly reveals this ugly truth, we know for a fact that USDA-Style HACCP has eviscerated the agency of meaningful authority … at big plants … by intentional agency design.

Carole Sugarman wrote an article in Food Chemical News on Nov. 14, 2003, in which she discussed a speech given by then-FSIS Administrator Dr. Garry McKee to a conference of FSIS circuit supervisors, district managers, and deputy district managers in Nashville, TN.  Some statements included:

“McKee said he is tired of reading articles that quote inspectors as saying they don’t have the authority to take action against a plant that’s violating its own HACCP plan or FSIS regulations.”

“McKee continued to hammer the point home.  ‘Once and for all, we must bury this notion that we do not have enough authority or we are not accountable for public health,’ he said.  ‘Those who do not believe this, or do not act on our given authority, will be held accountable from here on out.’ “  Yes, it’s the inspectors’ fault.  Yeah, right.

“Lastly, McKee said that inspectors must know how to ask for help if they are uncertain about what course of action to take, and he told the supervisors they must provide that empowerment.”

Apparently, McKee had not read OIG’s report of the ConAgra debacle.  A close study of his entire speech reveals that McKee placed blame for USDA’s shortcomings on allegedly incompetent inspectors, who had actually been emasculated by USDA-Style HACCP.

As food safety problems have emerged, and inspectors and food safety activists have pressed for common sense changes to the agency’s HACCP Hoax, the agency’s persistent response has been “Let HACCP work.”  Well, HACCP has now been in existence at the biggest plants for almost 13 years.  It should be fairly mature by now, but outbreaks and recalls remain persistent enemies, with no evidence of abatement, so what has gone wrong?   Answer:  USDA-style HACCP is not working.

My response must briefly touch on the monumental differences between Pillsbury’s legitimate and true HACCP system, compared with USDA’s woefully inadequate HACCP imposter.

Pillsbury’s HACCP plan was designed for cooked, ready-to-eat food, such as used by NASA and the Army.  Such products were consistently safe.  Pillsbury’s HACCP system was designed as a voluntary program.  In sharp contrast, USDA-style HACCP is mandated for all federally inspected plants.  And, USDA requires HACCP for raw meat and poultry, which is not r
eady-to-eat.

FSIS totally ignores the self-evident truth that raw meat and poultry cannot be pathogen-free in the absence of a kill step, such as provided by full cooking or irradiation.  Because products produced under Pillsbury-style HACCP are consistently safe, product testing is not required, and deregulation is appropriate.

Dr. William Sperber is a microbiologist who worked for Pillsbury from 1972 – 1995, fine tuning Pillsbury’s HACCP protocol into a superb scientific marvel.  Dr. Sperber authored an article in the December 2009/January 2010 edition of Food Safety Magazine entitled “Happy 50th Birthday to HACCP.”  Unbeknown to most of us, HACCP has been around for 50 years, and only recently introduced (and greatly revised) by FSIS.  Two of Dr. Sperber’s concluding remarks included the following:

“HACCP is a preventative system to control significant, identified hazards.”

“It [HACCP] does not rely on product testing or lot acceptance criteria.”

Both of Dr. Sperber’s conclusions are 180 degrees opposite of USDA-style HACCP.  Because FSIS prefers to conduct sampling/testing as close to the consumer as possible (and as far away from the source slaughter plant as possible), the agency is relegated to a reactionary stance, rather than preventative.  FSIS waits for outbreaks to occur, then commences a search for a downstream further processing plant against which all agency enforcement actions can be assessed.

If the agency is successful, it can then repeat Elsa Murano’s statement that the agency closes plants all the time (only small plants, of course).  To date, FSIS monolithically opposes tracebacks to the source of contamination, i.e., source-originating slaughter plants, when detecting E.coli & Salmonella in commerce.  The agency merely reacts, by forcing victimized downstream entities to implement corrective actions to prevent recurrences.

As such, FSIS dismisses the GIGO effect (Garbage in, Garbage Out).  FSIS has been paralyzed with fear of litigation from the large source slaughter plants if the agency were ever audacious enough to trace back to the source of contamination and attempt meaningful enforcement actions at the source.  The agency remembers its litigation losses against Supreme Beef and Nebraska Beef, neither of which are members of the Big Four packers, which slaughter 88 percent of our feedlot steers and heifers.

Sperber’s second conclusion above appears to be sacrilegious in today’s meat environment, realizing the incidence of pathogen-laced meat and outbreaks.  We must remember that USDA-style HACCP belongs in a different galaxy than Pillsbury’s HACCP protocol.  Since USDA mandates its HACCP Hoax on all raw meat & poultry plants, a sizeable amount of microbial sampling is imperative.  Pillsbury-style HACCP products need little if any testing, because they are consistently safe.  Admittedly, current meat plants which produce RTE products may function very well under the HACCP ideal, because they produce meat products that have been exposed to a kill step.

Bottom line:  true HACCP does not require microbial testing.  But USDA-style HACCP is not truly HACCP.

FSIS policy makers did, however, succeed in one of their objectives when the agency implemented HACCP.  All command and control was indeed removed from in-plant inspectors.  But it was not removed from the agency as initially promised.  Instead, command and control has been firmly entrenched in FSIS district offices and in DC, where bureaucrats make daily decisions from their remote locations, separated by time and space from actual plant operations.  Countless numbers of small plant owners have become aware of this agency bait-and-switch ruse, as evidenced by agency enforcement actions against victimized downstream plants

The value of the official USDA Mark of Inspection has also been questioned, as the agency voluntarily bequeathed its previous police ability over to the industry, has embraced a “hands off” non-involvement role, and allegedly jettisoned its command and control authority.

In June 2008, USDA 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 of the PowerPoint says “BASIC PRINCIPLES.”  The next sentence stated “Grinders with prerequisite programs should not rely on the mark of inspection to accept incoming product.”

As incredulous as this agency admission is, we must congratulate the agency for its refreshing candor in admitting the Mark of Inspection is valueless.  FSIS redoubled its disclaimer in FSIS Notice 05-09, dated Jan. 7, 2009, in which it stated in Section II (A):  “An establishment that receives, grinds, or otherwise processes raw beef products cannot conclude that E.coli 0157:H7 is not reasonably likely to occur in its production process because the product it receives bears the mark of inspection.”  Therefore, consumers should have NO confidence that USDA inspected and passed meat is wholesome.  This is yet another reason that USDA invests substantial funds to educate consumers, because the Mark of Inspection has lost all pertinence under USDA-style HACCP.

However, the new FSIS leadership team of Obama/Vilsack/Hagen/Almanza/Engeljohn may well constitute the first viable team at the top since the rollout of the FSIS HACCP Hoax in the mid-90s.  In a Sept 23, 2010 speech at the National Food Safety Conference, Dr. Elisabeth Hagen, the new USDA Under Secretary for Food Safety, made numerous statements that presage a new leadership attitude at the agency.

Hagen strongly endorsed prevention, while admitting the agency has spent too much time on reaction in the past.  She also referred to the need for tracebacks to the source.  Hagen’s laudable goals will be jettisoned if she is restrained by the agency’s current attitudes and policies.  Will she survive guaranteed court battles involved with any agency attempt to reintroduce “hands on” inspection policies, utilize police action, and re-embrace meaningful command and control?

Hagen will quickly perceive that the agency unwittingly painted itself into a feckless corner when it concocted its HACCP Hoax, and is now paying the price, just like consumers who are being unnecessarily sickened largely because of agency lethargy.

However, we do have one jewel on which to hold, which may provide a glimpse into what the agency portends the future to be.

On Oct. 8, 2010, only one month ago, FSIS issued Notice 58-10, which requires inspectors to document all source origination information, at the time of sample collection, when he/she collects samples of ground beef or trim for microbial analysis at USDA labs.  The fact that this procedure was not part and parcel of original FSIS HACCP protocol from day one reveals that the HACCP Hoax is far-removed from a scientific basis.

Past policy to delay such documentation until adverse lab findings are available is but one example of agency policies based in political science and science fiction, but not true science.  Only time will tell if FSIS survives guaranteed litigation challenges to Notice 58-10, which flies against agency promises to maintain a “hands off” non-involvement role, to not police the industry, and to disband command and control.

Inspector documentation of source evidence, at the time of sample collection, is in bald-faced opposition to FSIS pre-HACCP promises.  Does the agency
have authority, or does it not?  Will the tail wag the dog?  Better yet, which is the dog, and which is the tail?  Who is on first here, FSIS or the industry?

Recently I benefitted from a timely discussion with a friend about Notice 58-10, and its pertinence to this discussion.  My friend is a South African, and has been in the U.S. for 10 years.  He and his wife were quite surprised when they became familiar with food recalls in the U.S., as they had never encountered food recalls in South Africa.

He explained how all private labs in South Africa, in every industry, are linked with government labs.  The government labs can view all private lab results, in real time, in one integrated system.  If such a system was suggested in the U.S., many industries would cry “foul,” and energize their lobbyists to strangle such heresy even before legislation were to be introduced.

Bottom line:  FSIS regales in the deregulated meat non-inspection system known as USDA Style HACCP.  The agency has semi-retired at the largest plants, via HACCP’s deregulation.  Meanwhile, the agency has hyper-regulated the small plants, many of them out of existence.

Deregulation has insulated FSIS from delicately uncomfortable enforcement attempts against the big packers, who constitute a cozy future employer for agency employees subsequent to retirement from the agency.  However, as with all fraudulent ruses, the predictable results of lack of meaningful agency oversight at the largest source slaughter plants has resulted in recurring recalls and outbreaks, which not even FSIS can cover up.

Deregulation of the banking/investment industry likewise resulted in difficulties that were bound to occur, and the agency’s inappropriate deregulation of the big packers is having similar results.   FSIS has attempted to justify its HACCP ruse by painting it as “science based.”  FSIS merely used its form of HACCP as a Trojan Horse to implement a more comfortable deregulation format.

The Federal Meat Inspection Act was intended to promote public health, not agency comfort.

Lastly, if the authors of S 510 and HR 2749 truly desire the production of safer products, they would be best advised to totally reject any similarity to USDA-style HACCP protocol.  If these authors desire the destruction of small domestic food producers then, yes, they should emulate USDA-style HACCP.  They will merely make the big food producers bigger, and eviscerate rural America of small producers, while increasing our reliance on imported food of questionable quality and safety.

USDA-style HACCP was originally described as a pathogen chase, but quickly degenerated into a paper chase.  Industry behemoths have full-time staffs to play this paper chase game to perfection, while in reality they continue to ship pathogens into commerce, while our government hides behind the skirt of deregulation, fearful of litigation from large corporations and their associations.

FSIS successfully convinced America that its style of HACCP deregulation was science based, with obvious benefits for all.  How much longer will America be willing to pay the price for this FSIS feint?  Senators and representatives, consumer activists, and the media need to become cognizant of this intentional FSIS deception, which not only threatens public health, but also the viability of small American producers, who are being eliminated not because they cannot produce safe products, but because they cannot comply with the plethora of government and legislative mandates requiring mountains of costly and unnecessary paperwork.

I may only be one voice crying in the wilderness, but S 510 and HR 2749 have the potential for domestic disaster in the same realm as created by USDA’s HACCP Mega Reg.

We’d better get ready for a one-world government, because the rest of the globe will be providing our needs, and we’d better be in good stead with them.

If only Mark Twain were alive today, he would have a field day commenting on what the U.S. Department of Agriculture considers to be “scientific”.  

Subsequent to the Jack In The Box E. coli outbreak in 1993, USDA desperately and hurriedly implemented the current Hazard Analysis Critical Control Point (HACCP) protocol of deregulated meat inspection.  HACCP was originally invented by Pillsbury, focused on the production of consistently safe food for NASA and the Army.  Pillsbury’s HACCP required “Kill Steps” during food production, meaning that the food had to be subjected to a kill step such as fully cooking or irradiation, effectively killing all pathogens.  Pillsbury’s HACCP system was truly based in science, and creates safe food.

USDA intentionally changed the Pillsbury protocol, but of course, retained the right to classify its HACCP imposter as allegedly being “science-based”.  USDA’s Food Safety and Inspection Service (FSIS) demands that all federally inspected plants implement USDA-style HACCP.  Thus, FSIS requires that HACCP be used for all raw meat and poultry, which by definition does not utilize kill steps, but still qualifies for USDA-style HACCP.

Raw meat and poultry carry pathogens, such as E. coli and Salmonella.  These enteric bacteria originate in animals’ intestines, and can easily be deposited onto dressed carcasses via sloppy kill floor dressing procedures.  FSIS knowingly allows such enteric bacteria to be shipped into commerce from the source-originating slaughter plants.  The agency’s endorsement of shipping E. coli O157:H7 to downstream further processing plants, retail meat markets, and restaurants is an interesting case study.

A high percentage of beef shipped into commerce from slaughter plants is in the form of vacuum-packed intact cuts of meat, known as boxed beef.  FSIS allows such intact cuts, which are surface contaminated with E. coli O157:H7, to be shipped from the source slaughter plants to downstream further processing establishments.  FSIS blithely dismisses E. coli to be a mere contaminant when found on the surface of intact cuts.  However, when the downstream processor such as retail meat markets and restaurants process the intact cuts into steaks, roasts and ground beef which is laced with the previously-existing E. coli, FSIS nonchalantly concludes that the heretofore harmless E. coli have supernaturally morphed into adulterants.  FSIS places all blame for the existence of these pathogens on the downstream entity, accusing them of being noncompliant with sanitary food processing protocol.  

How did this absurd turn of events occur?  To answer this, we must briefly review statements made by FSIS in the 1990s as it tortured its definition of “science” in order to implement the agency’s pre-determined meat inspection system desired by FSIS.

In a series of meat industry conferences to publicly discuss USDA-style HACCP in the 1990s, FSIS stated that the agency’s role would change under HACCP to include the following:

1.  Under HACCP, the agency’s role would become “hands off“, instead of the traditional “hands on” role FSIS had previously embraced.

2.  Under HACCP, the agency would no longer police the industry, but the industry would police itself.

3.  Under HACCP, the agency would disband its previous command and control authority.

4.  Under HACCP, each plant could write its own HACCP Plan, and that the agency could not dictate what must be in these individually customized HACCP Plans.

History has shown that FSIS is fully compliant with these four pre-HACCP promises, but only at the largest plants which enjoy political clout and deep pockets.  Conversely, FSIS has used HACCP to hyper-regulate and hagride small plants, a startling number of which have exited USDA inspection.

One advantage HACCP gifted to FSIS was insulating the agency from liability for pathogens and outbreaks.  How could the agency be held even partially responsible for pathogens in the food supply when the agency was limited to a “hands off” non-involvement role, could no longer police the industry, and no longer enjoyed command and control authority?  FSIS can’t be responsible for meat it never inspected!  Another advantage is the comfort granted to the agency to embrace a semi-retired stance at the big packers, greatly reducing the delicate discomfort involved in challenging the largest plants when problems arise.  FSIS remains unaware of recurring problems, because it is relieved of its previous hands on policing role, coupled with loss of command and control authority.

During these afore-mentioned industry conferences, the agency made continuous references to the fact that USDA-style HACCP is “science based“, which allegedly would diminish the shipment of pathogens into commerce.  When conference attendees pressed FSIS spokespeople to explain why USDA-style HACCP is based in science, the agency explained that microbiological testing would be an integral part of HACCP.  FSIS spokespeople explained that HACCP would require extensive testing both by the agency, and by the meat plants.  In the 56 years my plant had operated prior to HACCP, I had never collected one meat sample for microbial analysis.  After HACCP’s implementation, both the agency and I have collected multiple dozens of samples for microbial tests.  Testing became the heart and soul of USDA-style HACCP.  

On January 26, 1998, the largest packing plants implemented HACCP.  A mere six days later, on February 1, 1998, FSIS issued Directive 10,010.1 which essentially exempted the large plants from agency-conducted microbial testing.  Plants killing thousands of beef daily became off-limits for FSIS sampling.  Meanwhile, the agency continued to test at smaller plants.  FSIS bureaucrats thus define “science” differently at small plants, compared to large plants.  What was the natural consequence of exempting large plants from USDA testing?

A superlative example of the impact of exempting large plants from agency-conducted sampling was exposed during the 19.1 million pound recall of E. coli-contaminated meat from the ConAgra plant in Greeley, Colorado in June 2002.  Exempted from agency-conducted sampling, ConAgra implemented a “multiple hurdle pathogen intervention system” which ostensibly “virtually sterilized carcasses”, as printed in a ConAgra marketing brochure.  Subsequent to the 19.1 million pound recall, the Office of the Inspector General (OIG) investigated the circumstances surrounding the recall.  One quote from OIG’s scathing report is, “Data was available to both ConAgra and USDA in the period prior to the recall that indicated that E. coli contamination was becoming a CONTINUOUS (emphasis added) problem at ConAgra.”   Instead of virtually sterilizing carcasses, ConAgra was continuously contaminating carcasses.  In the 100 days prior to the recall, ConAgra’s in-house testing revealed the presence of E. coli in meat on 34 of those days.  However, ConAgra did not implement corrective actions to prevent recurrences, and USDA did not mandate corrective actions, having been relegated to a “Hands Off” role absent command and control.

When critics reveal these glaring and intentional oversights, FSIS responds by stating that USDA-style HACCP is based in “science”.  Therefore, anyone revealing problems with USDA-style HACCP is discredited as being opposed to scientific advancements.  No one wants to be classified as opposed to science.  FSIS uses this lame excuse as an opportunity to silence all its critics, since who can argue with science? &nbsp
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Whenever any USDA official claims that agency policies are science-based, red flags should go up everywhere.  While the agency piously proclaims that its policies utilize an “abundance of caution”, evidence continues to reveal the agency operates under an “abandance” of caution, while hiding behind USDA-style HACCP’s skirt.  The agency’s slovenly recumbent lack of oversight at large plants is justified by its desire to maintain a “hands off” meat non-inspection role, its unwillingness to police the industry, and abhorrence at the prospect of using command and control authority at the largest slaughter entities.  The Big 4 meat slaughter companies kill 88 percent of our feedlot cattle, constituting a substantial adversary to an agency–which is paralyzed by the fear of litigation from the Big 4.  

“Science” to FSIS means agency semi-retirement at the largest slaughter entities.  This is a primary reason for our ongoing outbreaks and recurring recalls.  History has proven that USDA-style HACCP is NOT science-based, but based in political science and science fiction.  This is precisely the problem to which Mark Twain referred by extracting wholesale conjectures from a small investment of fact.  USDA intentionally bastardized Pillsbury’s HACCP program, while disingenuously classifying the agency’s deregulated system of non-inspection as “science-based”.  Consumers continue to pay the price for such sleight of hand.  

Oh what a twisted web we weave, when at first we intend to deceive.

These embarrassing recalls again reflect systemic problems within the USDA’s current deregulated method of meat non-inspection, called HACCP (Hazard Analysis Critical Control Point).  When the agency initially introduced the HACCP concept to the industry in the 1990’s, USDA stated that the two primary foundations upon which HACCP was built were prevention, and corrective actions in those few occasions when pathogens appear in meat.  Recurring recalls and ongoing outbreaks publicly reveal that agency HACCP policies constructed these two foundations on sand, absent true science.  

First of all, initial prevention is inadequate at the slaughter establishments, where E. coli bacteria are introduced into the meat supply via sloppy dressing procedures.  Secondly, when E. coli are detected at downstream plants, the agency focuses its enforcement actions primarily against the victimized further processing plants which lack the ability to prevent purchases of previously-contaminated meat from their source slaughter providers.  Since USDA forces the downstream plants to implement corrective actions to prevent recurrences, while insulating the source plants from accountability, corrective actions are understandably deficient.  Instead of forcing the source plants to utilize corrective actions to prevent recurrences, the agency makes the destination plants jump through a plethora of paperwork changes, which ostensibly would prevent the source slaughter plants from ever again shipping hot meat into commerce.  Since USDA intentionally places the wrong target into its cross hairs, the true target is misdiagnosed (by agency design), resulting in no efficacious corrective or preventive actions to eliminate future recurrences.  

Interestingly, Fairbank Farms previously announced an earlier recall on September 5, 2007, for 884 lbs of ground beef that may have been contaminated with E. coli O157:H7.  Obviously, one or more source slaughter providers to Fairbank Farms have not implemented meaningful corrective actions to prevent future production of pathogen-laden meat.  Fairbank Farms is not unique in being victimized on multiple occasions.  On February 24, 2004, Richwood Meat Company in Merced, CA announced a recall of 90,000 lbs of meat that may have been contaminated with E. coli O157:H7.  Three years later, on April 20, 2007, Richwood Meat Company announced a subsequent recall of 107,943 lbs of ground beef that was possibly contaminated with E. coli O157:H7.  

The slippery slope on which the agency slides with no rudder is further described In a June 2, 2005 letter from Dr. Kenneth Peterson, Deputy Administrator in USDA/FSIS’ Office of Field Operations, in which he states, “I would expect a prudent establishment to have appropriate procedures to determine product acceptability prior to receiving the product”.  USDA is fully cognizant that downstream plants have no control over the wholesomeness of incoming products.  While the source slaughter plants’ employees, as well as USDA inspectors assigned to the plants, fail to detect and remove enteric bacteria, the agency instead requires the downstream destination further processing plants to detect and remove these invisible pathogens.  Interestingly, previously-contaminated meat arrives at destination establishments in containers labeled “USDA Inspected & Passed“.  Since both the agency and the originating slaughter plants do not adequately inspect the meat on the originating kill floor, the agency now expects that inspection will subsequently be fully accomplished at the downstream establishments.  

Following the October 4 issue of the New York Times, which included the article entitled “E. coli Path Shows Flaws in Beef Industry“, the same Dr. Kenneth Peterson discussed the possibility of additional agency-mandated testing.  Dr. Peterson stated, “I have to look at the entire industry, not just what is best for public health”.  We should not fault Dr. Peterson for admitting the truth, as such candor constitutes a welcome change in the agency’s non-transparent method of formulating USDA meat inspection policies.  Instead, USDA/FSIS should be called to task for embracing biased, deregulated non-inspection policies as the Agency’s own, Dr. Kenneth Peterson so eloquently delineated.  The agency is more concerned with maintaining its comfortable relationship with the big packers than it is in protecting public health.  USDA chooses to ignore that the Federal Meat Inspection Act was implemented primarily to protect public health, not promote agency comfort.  

When USDA introduced HACCP in the mid-90s, the agency stated that HACCP was an improvement over its previous meat inspection system because HACCP was ostensibly “Science Based“.  The agency went on to state that HACCP’s scientific basis was predicated upon a large increase in microbial testing of meat products.  The biggest plants implemented HACCP on January 26, 1998.  On February 1, 1998, a mere six days later, the agency issued Directive 10,010.1, which essentially exempted the large plants from agency-conducted sampling.  This payback was not science-based, but big-packer biased.  In recent years, the agency has placed a much higher emphasis on testing, which is anathema to the original (and truly science-based) HACCP program as authored by Pillsbury in the 60’s & 70’s.  Realizing that substantial testing is contrary to Pillsbury’s HACCP protocol, we must consider why the agency has chosen to place such high priority in testing.  

Although USDA/FSIS has stated that E. coli O157:H7 is an adulterant in ground beef, the agency states that H7 is not an adulterant when it is on the surface of intact cuts.  These recurring recalls and ongoing outbreaks reveal that a substantial portion of intact cuts shipped to further processing plants carry a substantial load of E. coli residing on their surfaces.  Therefore, the idea of increased testing for E. coli is mandatory.  Rather than keeping the barn door closed, the agency is willing to let the horses out of the barn, only to subsequently attempt to detect the horses at downstream plants.  Therefore, because of increasing numbers of E. coli recalls and outbreaks, USDA/FSIS is forced to consider an increased incidence of testing, which hopefully will detect the presence of adulterated meat, and remove it from commerce, protecting consumers.  Rather than preventing the initial contamination of carcasses with enteric bacteria, the agency is more comfortable detecting the bacteria downstream, and then bringing enforcement actions against the hapless downstream facilities.  While detection has its merits, it must be subservient to initial prevention at the
source.  As long as the agency pays little attention to initial prevention at the source, detection has become the number one priority at USDA/FSIS.  

It is time that we reconsider USDA’s inadequate HACCP policies, which have contributed to the high incidence of recurring public health outbreaks.  The agency itself is fond of reminding small and very small meat plants that HACCP is a living, ever-changing entity.  As such, USDA/FSIS must be willing to conduct a mid-stream examination of its own HACCP policies.  If the agency were to do this, only then would we PREVENT enteric bacteria from entering the food chain.

Rather than experiencing these multiple public health outbreaks and recalls, we should instead demand that recalcitrant top agency officials be recalled in order to implement long-overdue and meaningful reforms which would truly promote public health and safe food.