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E. Coli Confession: Part 9

Editor’s Note: This is the ninth and final 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.

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official who visits a plant and requires that earlier “scientific” mandates required by previous agency officials be rescinded.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 source 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.

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

© Food Safety News
  • Steve

    John — thank you. This whole insider series is a devastating review of our so-called Safe Food System, the safest in the world they like to say. Problem is agribusiness-as-usual has co-opted our oversight agencies and is keeping the well organized corruption firmly in place — and everyone in the production-regulation business is making out OK except for the little guys.
    And, of course, especially not for the mounting listing of victims. What kind of a toll is needed before Organized Corruption becomes Criminal?

  • Maggie Henry

    Surely there must be some way to print out this series at once… I can’t focus on a computer screen that long.