Notice 05-09: HACCPgate Exposed

FSIS feels compelled to issue Notice 05-09 because of the failure of the meat industry to prevent, eliminate or reduce E.coli 0157:H7 to a less than detectable level, which has been glaringly revealed by the spate of E.coli outbreaks and recalls in 2007 & 2008.  This turn of events has caught FSIS and the industry by surprise, because the implementation of HACCP almost eleven years ago was heralded as a “science based” meat inspection system ostensibly capable of detecting and removing invisible bacteria from the food chain.

The focal (and fecal) point of Notice 05-09 centers on the need for every federally inspected establishment to employ whatever measures are necessary to ensure that it produces meat which is not contaminated with E.coli 0157:H7.  Similar to the agency’s proclamations in recent years, FSIS’ primary emphasis is not preventing E.coli’s initial entrance into the food chain at the pathogen’s source (slaughter plants), but relies on subsequent pathogen intervention steps at down line destination further processing establishments which unwittingly purchase previously-contaminated meat from their source slaughter providers.  In order to fully appreciate this dilemma, we must briefly review how the agency implemented the HACCP ideal which in retrospect explains the conundrum from which the agency is now unable to extricate itself. 

Back in the mid 90’s, FSIS mandated that all USDA-inspected plants commence implementing a HACCP Plan within a given time frame in order to retain their federal inspection.  In order to obtain “voluntary” compliance from the industry, FSIS dangled the following HACCP carrots in front of the industry, enticing the industry to aggressively embrace HACCP:

  1. Under HACCP, the agency’s role would be “Hands Off”.
  2. Under HACCP, the agency would no longer police the industry, but that the industry would police itself.
  3. Under HACCP, the agency would disband its previous command and control authority over the industry.  By now, plant owners are standing and cheering!
  4. Under HACCP, each plant could author its own unique HACCP Plan, and that the agency could not tell plants what must be in their HACCP Plans.
  5. HACCP was introduced as a “Science Based” meat production and inspection system, allegedly a stark contrast with the previous organoleptic system which was incapable of detecting invisible pathogens.  Since HACCP’s meat inspection protocol was now to be science based, and not dependent on senses such as sight, touch, smell, etc, the agency was justified in jettisoning its previous “Hands On” organoleptic meat inspection involvement.

 

These agency promises to deregulate the industry were sugar plums dancing in the heads of meat plant operators.  Now that the big slaughter plants have operated almost eleven years under this new “science based” deregulated “hands off” meat inspection system,
one would think that consumers could purchase meat with relatively fewer concerns than prior to the ostensibly unscientific pre-HACCP era.  Such thinking is erudite, but only theoretically.  Recent surveys have revealed that consumer confidence in the safety of meat has actually fallen, a concern justified by the numerous and sizeable E.coli outbreaks these last two years.  Diminished confidence is an embarrassment to the agency, because the rallying call around which FSIS initially marketed HACCP was “SAFE FOOD”, which was sorely lacking during the Jack In The Box outbreak; the absence of which created the need for a new and improved meat inspection system.   

Well, how does this tie into Notice 05-09? 

FSIS knows that E.coli 0157:H7 is an “enteric” bacterium, which by definition means it emanates from intestinal tracts, and by extension, from manure-covered hides.  The vast majority of USDA-inspected plants do not slaughter, but merely further process meat purchased from source slaughter plants.  These further processing plants have no intestines or hides on their premises.  Furthermore, this incoming meat arrives in containers proudly bearing the USDA Mark of Inspection.  Retail meat markets, restaurants, schools and hospitals likewise do not have beef intestines or hides on their premises.  These entities also rely on meat which originates from slaughter establishments.  It is logical to conclude that (1) FSIS would center its focus on the slaughter plants, and (2) force these source slaughter plants to implement corrective actions to prevent recurrences of their ongoing (albeit unintentional) production of carcasses with E.coli 0157:H7.  Shockingly, neither of these two goals is pursued by FSIS for reasons this position paper intends to reveal.   

The agency’s initial HACCP promises to the industry (see 5 points above) have painted FSIS into a corner, effectively eviscerating the agency of any meaningful authority.  This lack of authority prevents efficacious agency enforcement actions against the large source plants where E.coli is initially introduced into the food chain.  A failure to comprehend this fact will prevent anyone from understanding why E.coli outbreaks are increasing in size and number, as well as obfuscating the agency’s motive behind Notice 05-09. 

The huge slaughter plants have sizeable staffs of college-trained meat scientists, microbiologists, and other experts who are the foremost authorities on HACCP ideals and newly-emerging pathogens.  These PhD’s have designed multiple-hurdle pathogen intervention steps which are the envy of the world.  As an example, ConAgra’s 2002 marketing publications stated that their multiple-hurdle pathogen interventions resulted in a 6-log pathogen reduction, effectively “sterilizing carcasses”.  Soon thereafter ConAgra announced a 19.1 million pound recall.  And a subsequent OIG investigation stated and I quote “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) problem at ConAgra”.  OIG’s investigative conclusions do not reconcile themselves with the company’s previous claims to have pathogen intervention steps capable of “sterilizing carcasses”.  Instead, history shows that carcasses were being contaminated, not sterilized, on a continuous basis.    When truth runs contrary to theoretically erudite HACCP Plans, the written plans take precedence.  Truth is summarily dismissed as being part and parcel of the archaic organoleptic meat inspection system, a “poke and sniff” dinosaur relegated to ancient history. 

In all fairness to FSIS, we have to understand the delicate predicament in which the agency finds itself.  The agency promised it would maintain a “Hands Off” non-involvement role under the deregulated HACCP ideal.  It also promised the industry that FSIS would no longer police the industry, and that the agency would disband its command-and-control authority.  It also promised that each plant could author its own HACCP Plan, and that the agency could not tell plants what must be in their HACCP Plans.  Frankly, FSIS has voluntarily tied its own hands, and cannot implement enforcement actions against the huge slaughter plants whose accumulative scientific expertise overwhelms that exhibited by the HACCP-emasculated agency.  And, the huge plants have reams of scientific studies performed and validated by unbiased, impartial and independent 3rd party experts which prove that the plants simply cannot produce E.coli-contaminated meat.  To the credit of the big packers, these studies, coupled with installation of equipment and new production protocol have cost millions of dollars.  And yet, outbreaks of these enteric bacteria persist, to the pretended amazement of FSIS (but no one else).

An article appeared in FCNews on February 20, 2003, authored by Carole Sugarman, regarding the out-of-court settlement reached between FSIS and Nebraska Beef.  The agency had threatened to pull its inspectors from NB, which in turn sued to prevent the removal of inspectors.  The judge gave the two sides one week to accomplish an out-of-court settlement, and in the absence of a settlement, the judge would make his own determination.  The two sides DID reach a compromise agreement, which was the content of Carole Sugarman’s article.  The final sentence in the article stated:  “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”.  End quote.  Mr. Cohen’s candid statement revealed that the agency quietly admitted it lacked authority to withdraw inspectors from plants in spite of the fact that the agency is fully cognizant of recurring sanitation problems at the plants. 

The August 25, 2008 Food Chemical News included an article entitled “USDA says small plants need better ground beef tests”.  One statement from the article said “While small and very small processors make up 93% of the processing industry, they account for only 10% of all beef produced, Dan Engeljohn, FSIS deputy assistant administrator, told Food Chemical News”.  End quote.  This means that only 7% of the industry produces 90% of all beef produced.  It is understandable that FSIS concluded that small plants need better ground beef tests, because the agency knows only too well that these victimized small downstream plants are innocent recipients of vast amounts of previously-contaminated meat from their large source slaughter providers on a regular basis.  Since neither the big packers nor the agency are willing to detect and remove pathogens at the source, the next best step is to detect the invisible pathogens downstream somewhere.  It makes sense for the agency to intensify its focus at the 7% of the industry, especially at source slaughter plants which comprise this 7%.  But, such is not the case!  Why?

Big plants have political clout, and enjoy the economic wherewithal to engage the agency in protracted litigation whenever FSIS attempts to implement meaningful enforcement action against these big plants.  Essentially, the big plants are formidable opposition, especially to an agency which willingly acquiesced its authority over to the big plants on January 26, 1998.  In stark contrast, small plants do not have political clout, and lack the finances to challenge unethical agency accusations.  As such, they represent much easier enforcement prey to FSIS which is anxious to restore a shine to its tarnished public image.  Notice 05-08 represents the most recent attempt by the agency to shore up its PR façade.  FSIS is much more comfortable bringing enforcement actions against helpless small plants, and avoids the discomfort of challenging the big plants.  As such, current agency management ignores the fact that the Federal Meat Inspection Act was designed to promote public health, not agency comfort.

Since the small plants do not incorporate the multiple pathogen intervention steps in use at the big plants, FSIS considers the small plants to be noncompliant with HACCP ideals.  The agency enjoys a freedom to hagride the small plants with baseless charges that the small plants are the real culprit in these ongoing E.coli outbreaks.  As such, the agency insulates the large source slaughter plants from E.coli accountability, while transferring all liability against these victimized downstream plants, as well as retail meat markets and institutions whose primary fault is their assumption that the USDA Mark of Inspection has any connection to wholesomeness.  As such, FSIS is unwilling to force the source, but prefers to destroy the destination.  The agency could be less concerned that horses are being let out of the barn, but instead focuses its efforts to catch the horses after their release. 

When FSIS originally introduced the HACCP ideal to the industry, the agency stated that HACCP rested on two important aspects:  (1)  Prevention, and (2) Corrective Actions to Prevent Recurrences.  Indeed, if a plant’s Hazard Analysis, HACCP Plan, SOP’s, SSOP’s, and prerequisite plans are adequately thorough, pathogen Prevention would be a smashing success.  The January 19, 2009 FCNews quoted Tom Vilsack (nominated for the new Secretary of Agriculture) as making this statement:  “FSIS needs to focus on prevention(emphasis added) and mitigation to reduce the number of food borne illness outbreaks in the future”.  End quote.  To Mr. Vilsack’s credit, he repeats the agency’s 14-year old statement that Preventionis indeed vitally important.  Historical facts since January 26, 1998 however have revealed that the agency has intentionally placed Prevention on the rear burner, while focusing almost exclusively on Corrective Actions to Prevent Recurrences…….. ….at the downstream destination facilities, for reasons which should be increasingly obvious.  FSIS policy wonks discredit the GIGO affect. 

FSIS has gone on record twice in the last few months that the once-highly respected Mark of Inspection no longer provides assurance of product wholesomeness.  The agency is to be commended for their refreshing candor on this subject.  While the Mark of Inspection states “USDA Passed and Inspected”, HACCP’s deregulation now means that yes, the product passed, but regularly evades inspection, for “scientific” reasons.  This furtive circumvention constitutes an egregious violation against truth in advertising.

Until FSIS greatly modifies HACCP, it will find itself painted into a corner……but only at the big slaughter plants, where E.coli originate.  The agency enjoys and abuses its carte blanche power to bring inane enforcement actions against small plants which cannot successfully defend their constitutional rights against a power-hungry bureaucracy bent on removing small plants from USDA inspection. 

After close observation of FSIS policy decisions for ten years now, career field inspectors and veterinarians agree that HACCP is not based in science, but in political science and science fiction.  As such, Notice 05-09 merely constitutes the agency’s most recent prosaic attempt to cover-up HACCP’s multiple failures.  HACCP has also caused “cognitive dissonance” for dedicated agency employees.  This is a psychological conflict caused by holding incongruous beliefs simultaneously.  Honest agency inspection personnel who audaciously expose HACCP’s flim flam had best look for other jobs.  Inspection personnel and plant management are required to live a lie. 

We are witnessing a Perfect Storm, creating a Perfect Opportunity.  The perfect storm is the combination of increasing E.coli outbreaks, after almost eleven years of HACCP maturation at the largest slaughter establishments.  This is a dichotomy in terms.  The perfect opportunity is for FSIS to revamp or replace HACCP.  The agency can be proactive in this area, or reactive as is seen in Notice 05-09.  Interestingly, FSIS sold HACCP to America as being scientifically “proactive”, yet after almost eleven years of HACCP deregulation, the agency continues to resort to reactive measures, as in catching the horses after the barn gates have been left open (with tacit agency endorsement). 

This conundrum is further exacerbated by “Agency Capture”, in which a regulatory agency is captured or controlled by the very industry the agency supposedly regulates.  This unholy alliance mandates that any substantive agency change in policies must first be agreed upon by both sides involved.  This agreement is unlikely to occur if FSIS desires to revert to a “Hands On” involvement in meat inspection, and attempts to reclaim its traditional authority it voluntarily relinquished upon HACCP’s advent.  Will the new administration require a return to common sense?  Perhaps, but unlikely, because this two-headed monster will monolithically resist any meaningful changes.  Will Congress intervene to mandate pro-public health changes?  No, because they’ve done precious little to date, having been lulled to sleep by the constant drum roll of the need for “science-based” meat inspection protocol.  Not because science is inadequate, but because HACCP is a science fiction red herring.    

Other agency gaffes are highly pertinent and revealing, but will not be discussed in this position paper.  They include the agency’s quiet abandonment of Zero Tolerance, and the agency’s approval of slaughter plants’ shipment into commerce intact cuts (boxed beef) which is surface-contaminated with E.coli.  Some things are stranger than science fiction.

Just like multiple recurring E.coli outbreaks, we can anticipate endless agency releases of Notice and Directives in which FSIS swats at flies, while swallowing camels.  Only two future incidents have the capability to reverse this unsightly pathogen trend:

  1. Divine intervention, which is galaxies ahead of human interventions, which have proven to be greatly ineffective.  God can orchestrate human events which capture our imagination, and force changes.  Examples include Watergate and Monicagate.  HACCPgate is awaiting its turn.
  2. An unparalleled national E.coli outbreak, in which hundreds are sickened, and dozens die.  When this happens, the HACCP Hoax will be unraveled for all to see.

Personally, I like option #1 better.  Until one of these two occur, Notice 05-09 is but the tip of the agency’s HACCP/E.coli cover-up iceberg.

John Munsell
Foundation for Accountability in Regulatory Enforcement (FARE)
Miles City, MT
“True science benefits all”