Editor’s Note: This is the second installment 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.
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© Food Safety News