The Fox and the Henhouse

HACCP was rushed into existence in what many observed to be an agency knee-jerk reaction to the Jack In The Box outbreak.  An improvement in meat production and inspection was clearly required to reduce the prevalence of pathogens in our food supply.  Since E.coli 0157:H7 was the focal point driving inspection policies, we need to briefly discuss its particulars.

E.coli 0157:H7 and Salmonella are enteric bacteria, that is, originate within animals’ intestines and are prolific on dirty hides.  Other bacteria, such as Listeria, emanate within the environment, do not require the presence of animals, and can be somewhat ubiquitous.  Further processing grinding plants which do not slaughter have no intestines or hides on the premises, thus are almost always the DESTINATION of E.coli and Salmonella-contaminated meat, but not the ORIGIN.  The promotion of public health requires the true origin of contamination to be scientifically identified in order for corrective actions to be implemented at the appropriate meat establishment. 

Industry events since HACCP’s implementation have lead many to believe that the agency lacks adequate legal authority to take enforcement actions against plants which FSIS perceives to have recurring sanitation problems.  It has also been suggested that HACCP has exacerbated the agency’s inability to utilize such legal empowerment.  I agree somewhat, but am inclined to place more emphasis on the agency’s tepid unwillingness to challenge the large slaughter operations.  An article by Carol Sugarman in Food Chemical News dated 2-20-03 described the agency’s out-of-court settlement with Nebraska Beef.  The article included the statement “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”.  This is an extremely revealing agency admission.  FSIS admits that even when they perceive a plant has unsanitary conditions, the agency (a) lacks authority to take enforcement actions, or (b) the agency lacks the fortitude to challenge an allegedly non-compliant plant in court.  We must remember that previous to this incident, the agency lost, appealed and subsequently lost again its litigation with Supreme Beef. 

While my perception is that the agency has lost its courage to confront big packers while defending public health, it may indeed lack the legal authority to take decisive actions.  A common perception is that when the agency finds itself in an uncomfortable scenario with the big packers, the agency feigns disappointment, puts on its best thespian face, and dejectedly concludes that it lacks authority to take decisive action.  If the agency truly lacks legal authority, then why isn’t the agency aggressively pressing for legislation which would bestow such authority? 

Numerous experienced FSIS field employees, both retired and currently employed, have stated their perception that the agency changed its focus from public health to minimizing agency liability upon HACCP’s advent.  This is foundational to understand in any discussion of current meat inspection/HACCP inadequacies.  The advantage to FSIS for changing its focus is obvious.  Whenever food borne outbreaks occur, the meat plant is deemed to be exclusively responsible because of an apparent breakdown in their implementation of, or a design problem in, their written HACCP plan.  The agency is now merely an innocent bystander, thereby not responsible for food safety failures.

Abbot and Costello made famous their “Who’s on First” gig.  HACCP’s gig is to portray that the industry is on first, calling the shots, which is partially true, especially if the agency lacks legal authority to take enforcement actions. 

HACCP unfortunately is theoretical.  On paper, HACCP is profoundly erudite.  When Pillsbury authored it in the 60’s, HACCP was designed to produce guaranteed safe food for astronauts to use in outer space where living environments had no room for vomit or diarrhea.  It’s not too late to acknowledge that Pillsbury’s HACCP program was designed for ready to eat food, while FSIS believes it can be morphed into the production of raw meat.  Elsa Murano was right on the money when she said “There is no such thing as risk-free raw meat”.  

When HACCP made the transition from theory to real-life applications, it lacked the prerequisite national standards (safe harbors) necessary for FSIS and the industry to determine the minimum criteria which must be maintained to ensure compliance with regulations.  But, what regulations?  Traditional agency regulations were jettisoned upon HACCP’s advent.  In the absence of regulations and national standards, meat production devolved to each plant’s construction of theoretical methods to produce safe food.  This theoretical basis has lead to countless examples of failed theory.  It has also created conundrums in which the agency is forced to either take action against acceptable scientific models or do nothing because of a fear of being perceived as anti-science.  FSIS-style science is like mathematics.  Figures don’t lie, but lies figure. 

One of many superlative examples of HACCP theory failure when contrasted with real-life occurrences was observed during ConAgra’s 19 million pound recall in 2002.  Prior to the recall, ConAgra disseminated literature to its customers extolling its multiple-hurdle intervention system.  One article entitled “The Strongest chain of Safety” referred to a NCBA-supported study conducted by Colorado State University which validated in-plant conditions at all ConAgra Beef Company plants.  One conclusion was “….the study 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”.  ConAgra subsequently introduced its TOR (Thermal Organic Rinse) system which added an additional one log reduction, resulting in a 7-log reduction.  Their carcasses must have been super-sterilized!

In September, 2003, OIG released its report stemming from its investigation of the ConAgra/Galligans/Montana Quality Foods recalls from 2002.   One quotation from the report stated “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”.  Impossible, this simply cannot be!  A plant which “virtually sterilizes” its carcasses cannot be guilty of “continuous” contamination of meat.  Especially when it employs a 7-log multiple hurdle intervention system on its kill floor.  This historical fact reveals the obvious disconnect between HACCP theory and reality. 

What are the methods available to FSIS to independently validate a plant’s success in complying with its HACCP plan, and its success in consistently producing safe food?  Unfortunately, agency personnel actions have been relegated to a mere auditing of paper flow, mostly divorced from visual (organoleptic) observation of actual production line activities (except on slaughter floors).  How did this occur at ConAgra, and what lessons have we learned? 

The previously-mentioned OIG report provided several other statements with direct relevance to this conversation.  One such statement said “USDA Inspectors followed policies that effectively limited the documents the inspectors could review and the enforcement action they were allowed to take”.  The OIG report revealed that agency policies prevented inspector access to pertinent ConAgra daily HACCP records, including microbial test results.  As a result of the OIG report, FSIS issued a new policy which stated that the agency DOES have access to all plant records, even if they were “outside” the HACCP plan, which ConAgra claimed exempted them from releasing lab results to the agency.  A truly science-based inspection system would never have allowed meat plants to withhold such important records from a government meat regulatory agency, but HACCP did, with the agency’s tacit approval.  The OIG statement quoted above revealed that both the agency and the company were cognizant of the continuous production of contaminated meat, but neither the agency nor the company felt compelled to require or initiate corrective actions to prevent recurrences.  Even if FSIS had the legal authority to mandate enforcement actions at ConAgra in this instance, the fact that neither the agency nor ConAgra unilaterally embraced corrective actions proves that neither side was fully committed to the goal of safe food, notwithstanding the claim of a theoretical 7-log reduction supposedly in place. 

Another OIG statement said “USDA had reduced its oversight short of what was prudent and necessary for the protection of the consumer”.  Again, FSIS concludes that responsibility for all food safety violations is placed exclusively at the doorstep of the meat establishment, and the agency shares no liability.  Therefore, under the HACCP environment, “the protection of the consumer” is now fully the responsibility of the meat plant since the agency is merely a bystander under the HACCP umbrella. 

Another OIG statement said “Although animal feces on product was repeatedly observed during production at ConAgra, USDA took no enforcement actions”.  At least at the big plants, the agency interprets HACCP methodology to mean that FSIS is not obliged to initiate enforcement actions (even when continuous production of fecal-contaminated meat exists), but rather that the plant has the responsibility to unilaterally detect and independently correct noncompliances.  At least at the large plants, FSIS has morphed into a relative non-entity.

Another OIG statement said “USDA did not take enforcement action against ConAgra even though it continued to cite the plant for HACCP violations involving visible fecal contamination of products”.  At least at the big plants, continuous instances of fecal contamination of meat are fully resolved via multiple NR’s, which are not linked, and no validation of the success of purported corrective actions is required.  All across America, small and very small plants have been issued NOIE’s and threatened suspensions for a variety of contrived accusations of noncompliance with relatively minor problems with their HACCP plan design, many of which have zero impact on food safety or the plant’s ability to produce wholesome food.  In stark contrast, the agency adroitly avoided any attempt to force ConAgra to implement corrective actions to prevent recurrences of its continuous production of fecal contaminated meat, undoubtedly a major threat to food safety. 

The important conclusion is that the agency perceives that it has unlimited legal authority to close down small and very small plants for very minimal alleged “violations” of HACCP methodology, but treads very lightly when observing major violations at big plants, hiding behind the excuse that it lacks statutory and legal authority for enforcement actions.  This dichotomy reveals that the real issue here is not the presence or lack of authority, but the willingness of the agency to challenge the large packers.  We must acknowledge that small plants lack (a) political power to bring pressure against the agency to back off, and (b) the economic largesse required to engage the agency in protracted litigation.  FSIS knows this, and responds by hagriding small plants, while insulating large plants from responsibility even for obvious noncompliances such as continuous production of fecal-contaminated meat.

One response the agency used subsequent to the ConAgra recall was a statement issued by Linda Swacina on 7-15-02 which said in part “In order to expedite recalls even more, FSIS will now inform the suppliers to a further processing facility, both verbally and in writing, when a positive E.coli 0157:H7 sample is discovered in ground beef supplied to that facility.  This will allow all the suppliers to take proactive steps without waiting for results from the FSIS investigation”.  Does this agency public relations gimmick offer much benefit to consumers, or to victimized plants which received contaminated meat?  How does this play out in real life?  An example can be seen from the June 29, 2003 recall announced by Stampede Meat in Chicago, a further processing plant which does not slaughter.  Stampede Meat had 38 suppliers at the time.  Did the agency require all 38 suppliers to reassess their HACCP plans since they had a one in thirty eight chance of being the guilty supplier to Stampede?  The only activity available to those 38 suppliers was to review their HACCP records for the production dates involved for products purchased by Stampede which led to the recall.  There is no likelihood that any of the supplier plants knowingly produced and shipped contaminated meat during the time frame involved, or during ANY time frame.  Public health demands a scientific and expedited determination of the ONE guilty supplier plant, as well as implementation of enforcement actions against this ONE plant.  FSIS mass mailings to 38 plants with imprecise and non-specific allegations is an exercise in futility, but does have PR benefits.

To the agency’s credit, it is compiling a list of supplier plants which sell product to downline further processing plants where lab results have detected pathogen-contaminated meat.  Dr. Daniel Engeljohn stated on December 5, 2006, that 35 supplier plants are on this listing, of which 13 plants are listed more than once.  When does FSIS initiate enforcement actions against plants whose names appear on this list numerous times?   After two hits, twenty, or two hundred, if at all?

The ability to fully understand how today’s relationship has evolved between the agency and the industry requires a historical review of FSIS’ foundational HACCP definitions as initially presented to the industry.  When FSIS presented HACCP to the industry, actively desiring the endorsement and participation from the industry, the agency made numerous statements about HACCP, some of which included the following:

“Under HACCP, the agency’s role will be Hands Off.”

“Under HACCP, plants must police themselves, as the agency will no longer do so.”

“Plants must write their own HACCP plans.”

“FSIS can’t tell plants what they have to do, and cannot tell plants how to write their HACCP plans.”

“Under HACCP, the agency’s previous command and control system will be no more.  Again, plants must police themselves.”

These agency promises constituted delectable enticements which the industry swallowed hook, line and sinker.  Events in subsequent years revealed that the agency promises to disband command and control functions were tantamount to officially sanctioned bait and switch actions.  Furthermore, at least at small plants, FSIS personnel regularly instruct plant management how to write HACCP plans while rejecting portions based on subjective interpretations which even the Technical Service Center cannot resolve. 

FSIS also sold HACCP on the basis that HACCP is science based compared to the then-existing archaic organoleptic system, criticized as a dinosaur “poke and sniff” method.  The scientific basis of HACCP was based on the implementation of microbiological testing for harmful pathogens.  The agency currently collects approximately 11,000 microbial samples per year, supplemented by thousands of company-conducted samples. 

FSIS conducted a baseline analysis of trim sampling this past year, and discovered that the incidence of E.coli 0157:H7 in trim was three times its incidence in ground beef, 0.6% vs. 0.2%.  As a result, the agency decided to reduce its sampling of ground beef at grinding plants and replace it with trim sampling at slaughter plants.  This represents a radical and erudite departure from traditional agency thinking.  Subsequent to the Jack In The Box outbreak, the agency concluded that public health would best benefit from microbial testing as close to the consumer as possible.  While such thinking sounds plausible at first blush, such testing is performed as far away from the source of contamination (slaughter plants) as possible.  This enlightening fact has been adroitly avoided in agency press releases.

Public health interests are best served by a sizeable sampling not only at slaughter plants, but also at the smaller further processing plants.  The value of end-product sampling was well explained by Dr. Dell Allen, who at the time oversaw plant operations for Cargill/Excel when he stated “Finished-product testing is the most sure method to know whether you’ve got H7 in your products or not.  When we first started doing it we thought our systems were pretty good.  Finished-product testing showed us we were not as good as we thought we were.” 

Critics have challenged FSIS to greatly increase the frequency of its testing not only at slaughter plants but also at downline further processing plants, but the agency is mostly unsympathetic to this request.  The agency’s reluctance to perform a dramatic increase in testing can be easily understood, for the following reasons:

  1. Recurring lab positives would reveal that plants continue to produce unsafe food.
  2. Adverse lab results would reveal that HACCP does not guarantee safe food as originally envisioned by Pillsbury for the NASA program.
  3. Lab positives would reveal that HACCP created a system in which FSIS is asleep at the wheel.  This has allowed contaminated meat to be shipped into commerce in containers bearing the official USDA Mark of Inspection which says “Inspected and Passed”.  Passed indeed, but frequently uninspected because of the agency’s Hands Off semi retirement status.
  4. Recurring lab positives would reveal that while HACCP may be theoretically plausible, it frequently doesn’t work in real-life applications where the government regulatory agency is discouraged from utilizing allegedly archaic organoleptic inspection procedures.  To a great degree, FSIS personnel activities have been limited to monitoring of plant-generated paperwork, the accuracy of which cannot be independently validated.  It has been suggested that FSIS should be renamed FSAS, Food Safety Accounting Service. 

HACCP is no longer primarily involved in a pathogen chase, but a paper chase. 

Further exacerbating the problem are agency policies which have been intentionally designed to prevent, or at least obfuscate, the true origin of contaminated meat.  When FSIS personnel collect ground beef samples for analysis at USDA labs, the personnel are prohibited from documenting the origin of the sampled meat on the day of sample collection.  Instead, Directive 10,010.1 Rev 1 requires that source origination evidence be collected on the day that the sample is designated as a “confirmed positive”.  This designation requires a minimum of four days, by which time the trail of evidence has turned cold and the agency has no method to validate the accuracy of data presented by plant management. 

It is interesting to note that subsequent to the ConAgra recall, the agency instructed its personnel to collect all source evidence at the time of sample collection.  This procedure was rescinded a mere two months later “for legal reasons” according to one agency official.  In the absence of validated SOURCE information, corrective actions to prevent recurrences cannot be accomplished.  Since the true origin of contaminated meat cannot currently be accomplished, the agency focuses all its enforcement actions at the downline further processing plants which purchase meat from supplier slaughter plants.  2006 has witnessed eight recalls of E.coli 0157:H7 contaminated meat.  All eight have occurred at small plants, six of which do not slaughter.  No recalls have been required at the slaughter plants which sold meat to the six – eight further processing plants, because the agency has no interest in performing tracebacks to the true origin of contamination.  If tracebacks were performed, and a large slaughter plant was identified as the origin of contamination, FSIS would be forced to implement enforcement actions at the large plant.  The agency is reluctant to do this………at the big plants, while FSIS aggressively pursues smaller plants with a vengeance.  Recurring recalls from small plants paint the agency as a proactive protector of public health, while using a broad brush to paint small plants as the ugly step sister allegedly unwilling to embrace scientific meat inspection protocol. 

When USDA labs detect E.coli positives, and FSIS enacts enforcement actions at downline further processing non-slaughter grinding plants, these actions prematurely truncate investigations which if allowed to proceed without artificial restrictions could frequently identify the true ORIGIN of contamination.  This constitutes a major flaw in FSIS HACCP design and implementation, yet the agency steadfastly refuses to correct this unscientific protocol.

The primary guilt observed at small plants is their assumption that previously inspected meat is indeed devoid of pathogens.  After all, this meat arrives at their docks in containers bearing the USDA mark of inspection, which at one time was associated with product safety.  Since incoming pathogens are invisible, the only options available to small plants to decontaminate incoming meat include irradiation, full cooking, or chemical intervention steps.  The capital outlay to implement such interventions are typically out of the reach of most small plants, who have now been assigned full accountability to dry clean previously contaminated meat. 

This quandary can be easily overcome if only the agency would leave no stone unturned to determine the true SOURCE of contamination, and force the source plant to implement effective corrective actions to prevent recurrences.  Subsequently, both the plant and the agency should conduct substantial microbial testing to ensure that the corrective actions are efficacious in preventing ongoing production of contaminated meat. 

Initially, whenever a plant experienced a lab test which was positive for E.coli, the agency would initiate an additional 15 consecutive days of subsequent testing to determine if the plant had an ongoing problem, or was the one positive sample an isolated incident.  The agency has since rescinded this common sense policy, and we have to question the agency’s reasoning.  Prior to ConAgra’s 19 million pound recall, FSIS used this 15 sample protocol at two plants which produced five more positives, the results of which lead to the ConAgra recall.  Interestingly, the agency still utilizes the 15 sample protocol, but only on imported meat.  Quite frankly, if the agency desires fewer recalls and minimized adverse media publicity, diminished micro testing is the answer, especially at plants which have recently experienced lab positives and/or recalls.  What we don’t know won’t hurt us. 

Benefits to be learned from the Supreme Beef case have been overlooked.  How can a downline, further processing, non-slaughter grinding plant be held responsible for the recurring presence of Salmonella found in meat which was previously contaminated and undetected at its upline supplier slaughter plant?  The fact that Salmonella was detected in numerous subsequent tests at Supreme Beef should have energized the agency (and Supreme Beef) to commence a substantial testing protocol on all incoming trimmings.  Instead, FSIS placed all blame on the downline grinding plant which had no control over sanitation conditions at its supplier slaughter plants.  Dangerous sanitation and pathogen problems will persist until FSIS proactively traces back to the SOURCE of contamination, and courageously implements enforcement actions at the true source plants, regardless of size.

The February 24. 2006 agency-sponsored conference to discuss the new FSIS Salmonella Initiative heralds a new agency attitude towards addressing the SOURCE of Salmonella-contaminated meat.  Two agency speakers, Dr. Daniel Engeljohn and Dr. Patricia Bennett, both commented on the need to place primary emphasis on SOURCE materials at slaughter establishments.  FSIS is to be commended for its audacious boldness in admitting that SOURCE determination of Salmonella is now an agency priority.  This admission hopefully presages the time when FSIS will adopt a similar commitment to addressing the SOURCE of the other enteric bacteria, i.e. E.coli 0157:H7.  Current FSIS leadership is displaying a heretofore unseen courage to “force the source” plants to remedy their sanitation problems, instead of exclusively applying agency enforcement actions downstream at hapless further processing plants.

Before HACCP’s advent, FSIS promulgated regulations which all inspected plants were required to meet.  With HACCP’s implementation, each individual plant is required to write its own plan, accumulate scientific justifications and process authorities to justify their HACCP decisions, while previous agency regulations have evaporated.  Current lack of national standards (safe harbors) has led to enormous confusion in the field, both for agency personnel as well as for industry officials.  HACCP decisions at one plant are accepted by FSIS, yet rejected by agency personnel at other plants as being “inadequate, incomplete, and unscientific”.  Resulting appeals which have been directed at the Technical Service Center for a definitive resolution sometimes go unanswered, and TSC’s decisions are frequently confusing and contradictory………….all because of the lack of national standards.  Logical national standards would be objective, as opposed to the plethora of existing subjective ideas and inconsistent agency interpretations. 

Dr. Richard Raymond has stated that once the TSC or other FSIS officials have provided answers on inspection issues, that the answer should be posted on the agency website allowing the entire nation to use the same answer.  Unfortunately, this common sense idea has not yet been fully implemented, requiring exasperated agency personnel and badgered plant owners to reinvent the same wheel countless times.  The wheels are sometimes round, but frequently square, rectangular or octagonal……but seldom consistent.  NR’s and NOIE’s are regularly issued by ill-motivated and/or ill-trained agency personnel against one plant for alleged “noncompliant” plant actions which the agency deems acceptable at other plants.  This does not bode well for a “science based” meat inspection system.

The suggestion is frequently heard that since the primary “scientific” advantage to HACCP is the addition of microbial testing, that the agency should have maintained all its previous regulations (and scientific justifications!) for HACCP use and simply added microbial testing to the mix.  Plants should be able to utilize the agency’s previous scientific justifications in their HACCP plan designs, but the agency has judiciously emptied their old files, avoiding industry access.  It is possible that the agency previously lacked adequate scientific justifications for their regulations.  If so, how can the agency expect small plants, with limited time and resources, to locate or create new scientific data which the agency previously could not produce in spite of its advantage of having a large scientific staff?  If the agency did previously have scientific data, why isn’t it aggressively disseminating it to the industry?  If the agency would willingly share this data, its strained relationship with and confusion reigning in the industry could be ameliorated, but only if the agency sincerely desires to “PARTNER” with the industry to achieve common goals. 

Examples of needless confusion and enforcement actions are endless, but one will suffice for this discussion.  Prior to HACCP, the agency required a maximum processing room temperature of 50 degrees.  Whenever a plant’s temperature exceeded 50 degrees, the plant was required to conduct a mid-shift cleanup within five hours.  Subsequent to HACCP, one plant owner established a maximum of 45 degrees, a 5 degree improvement over the agency’s traditional standard.  A relief inspector subsequently notified the plant that it lacked adequate justification for establishing its 45 degree maximum.  The plant owner displayed all the scientific articles used by other plants, which were obtained from AAMP, NAMP, and NMA and which the agency deemed acceptable in other plants across the country.  The relief inspector was not to be deterred, and commenced issuing an NR.  The plant owner called the inspector’s supervisor and District Office, and the inspector’s behavior was quickly brought under control.  The inspector’s subjective allegation that the plant’s 45 degree maximum was insufficient reveals the unscientific nature of HACCP and constitutes an egregious agency bias lacking national consistency.  We have to assume that FSIS had scientific justification for its previous 50 degree regulation.  If so, the agency should release its scientific data for industry use to avoid recurrences of this unnecessary FSIS enforcement action.   Even folks from outside our industry have questioned why the agency doesn’t voluntarily share their previous data.  The answer is simple, and easily understood.

If the agency would release its previous scientific findings and authorize plants to incorporate this data into their HACCP plans, and the plant subsequently produces contaminated meat, then the agency might potentially share liability for the failure.  As stated previously, the agency’s traditional focus on safe food has been replaced by the overriding desire to minimize agency liability under the HACCP umbrella.  The agency’s interests are best met by requiring every plant to produce its own studies to justify their meat processing activities, so that the plant alone can be held solely liable for its production of contaminated meat.  It is simply incongruous to consider that a government agency with several decades’ experience of conducting scientific tests would jettison all its data and require each plant to expeditiously replicate the findings or lose its ability to operate in the HACCP environment. 

Admittedly, HACCP has allowed plants to personalize their HACCP plans to their unique set of production circumstances.  Large plants, with full-time staff dedicated to authoring, updating and maintaining their HACCP plans can easily accomplish this task.  HACCP has been a godsend to large plants, and an unmitigated disaster not only for small plants, but for the thousands of dedicated FSIS field staff who lack objective national standards from which to make intelligent decisions.  Small plants are regularly criticized as being ignorant of HACCP theory, and unwilling to change their mind set to current “science-based” methodologies.  However, even the inspectors at these plants lack access to consistent answers to relatively minor issues, an inspection quagmire which has fomented an adversarial attitude towards the industry.  The agency could still allow plants to design their own HACCP plans, but must release their historical scientific data (which once formed the basis of agency regulations) to the industry as well as to its field force.

In 2006, an agency FSA was conducted at a small plant which had a total workforce of one person.  This person acted as both the monitor and verifier on all his daily HACCP forms.  The EIAO performing the FSA objected to the procedures used by the plant owner, and commenced to issue an NR.  Fortunately, the plant owner produced documents from the TSC and SIPO which justified his procedures, denying the EIAO the opportunity to issue an undeserved NR.  The point is this:  if the plant owner lacked the correspondence from FSIS officials, he would have received an NR.  The NR not have reflected illegal activities or maintaining unsanitary conditions, but the owner’s unwitting failure to have paperwork on file for every step in his operation, regardless of how miniscule the step was.  Regardless of how complete a plant’s compilation of scientific justifications may be, EIAO’s and other agency officials can always concoct alleged deficiencies which require time and energy from plant owners to resolve, even for the most insignificant issue.  Since the agency requires picture perfect and complete paper file systems for every production step, then the agency must previously have had a similar file of scientific documents in existence.  The agency needs to disseminate this data, if they ever had it. 

Again, HACCP has degenerated from a pathogen chase to a paper chase.

All too often, FSIS field personnel don’t know where solid ground is to be found.  Constantly shifting and contradictory subjective opinions from various supervisors and the TSC create uncertainty, confusion, and animosity within the agency.  It is no surprise that the agency has difficulty attracting and retaining employees who are exiting FSIS for APHIS and other calmer, saner waters where true science is utilized and employees are authorized to use their talents in the absence of mandated confusion.  These alternative employers reward, rather than punish, scientific devotees who consistently adhere to genuine scientific principles rather than succumb to dumbed-down unscientific mandates. 

It is disconcerting to observe the agency’s devaluation of the usefulness of veterinarians under the HACCP mentality.  Vets with advanced degrees in scientific curriculum are being ushered out of FSIS, and are being replaced with avant-garde graduates of the agency’s EIAO diploma mill.  The agency’s ultimate trump cards in resolving scientific questions are being unceremoniously eliminated from the very system which purportedly demands a solid scientific foundation.  Since the agency’s current implementation of HACCP depends on inconsistent and subjective personal opinions, veterinarians have lost all relevance.  This portends a rocky, unstable future for a “science-based” meat inspection system. 

Frankly, when agency bureaucrats require its field force to implement indefensible and unscientific protocol, they encounter resistance from college-trained vets who are professionally committed to consistent scientific principles.  These vets are truly politically incorrect because of their intolerance towards unscientific mandates.  Veterinarian primary loyalty to scientific principles has unfortunately made them dispensable under HACCP, where they are now perceived as being overly qualified, which they are.  Science has been trumped by agency authority. 

Most plants can describe a plethora of stranger-than-fiction events which have transpired since the arrival of CSO’s and EIAO’s.  Initially, individual HACCP plans were reviewed and monitored by inspectors, mini-circuit supervisors, circuit supervisors, and frequently District Office personnel.  When a new inspector or supervisor was assigned to the plant, a new list of “deficiencies” was authored, supposedly revealing that all previous agency personnel as well as plant management were not conversant with HACCP methodologies.
CSO’s then arrived on the scene, and promptly issued a new list of inadequacies and noncompliances, including the lack of adequate scientific justifications.  When plant management asked where such scientific articles could be found, the CSO’s were prevented from sharing source information.  Again, all previous agency personnel were pictured as lacking HACCP intelligence.  EIAO’s then arrived, and issued additional laundry lists of alleged HACCP design and implementation failures, oftentimes contradicting earlier agency decisions.  We must remember that all these “failures” existed in HACCP plans which had been previously designated as acceptable by numerous agency personnel.  Again, plant management and agency personnel were downgraded as either ignorant in HACCP philosophy or allegedly unwilling to embrace HACCP ideals.  Rest assured that the next EIAO will fabricate another detailed exposure of previous mental mishaps by FSIS personnel and plant representatives.  Many of the future alleged “inadequacies” will directly contradict the current EIAO’s findings.  Nevertheless, insightful plant owners are wise to submit to the demands of the newest EIAO simply to keep their plants operational. 

FSIS reviews of individual HACCP plans have degenerated to a game of regulatory one-upmanship.  This childish game is designed to elevate the supposedly superior mental capabilities and allegedly advanced scientific knowledge of the newest agency visitor, while denigrating all previous agency personnel as well as plant management.  This attitude is justified by the claim that “science continually changes”.  In actuality, the agency defines “science” in contradictory ways in each plant, arguably lacking consistency.  This is not science, but subjective personal opinions.  This is not what Pillsbury originally intended. 

Industry critics have stated, not totally tongue-in-cheek, that HACCP means “Hardly Anyone Comprehends Current Policy”.  Whether this nomenclature is justified or not, it points out the fact that HACCP is driven by personal and subjective interpretations of issues lacking a consistent scientific answer. 

To the agency’s credit, in 2005 & 2006, EIAO’s have been authorized to inform plants where scientific articles can be found.  FSIS has always been privy to such information, but had previously enjoyed tormenting and harassing these relatively “ignorant” plant owners whose normal business operations were unnecessarily interrupted for the lack of answers which the agency unethically withheld.  All in the name of “science”.  If the agency successfully embraces and implements the goal of partnering with the industry as courageously suggested by Dr. Raymond, a watershed change in agency mindset and attitude must first take place.  As small plant owners have experienced, many agency personnel are reluctant to surrender their command and control authority.

The dissemination of information and training materials to the industry by FSIS has resulted in one major benefit, which is a dramatic reduction in recalls.  FSIS and the industry’s meat associations have successfully recommended that plants implement “Test and Hold” protocol for all meat involved in microbial sampling.  If the eight plants which experienced E.coli recalls in 2006 had utilized “Test and Hold” procedures, we would’ve had zero E.coli recalls in 2006.  It doesn’t mean that they didn’t PRODUCE contaminated meat, but simply that they didn’t SHIP the contaminated meat into commerce, a monumental distinction.  Whether the bad meat was shipped or not, the primary long-term benefit would have been the determination of the plant which INTRODUCED the contaminant, and require corrective action at that plant.  Instead, FSIS is more interested in reducing the embarrassing number of recalls than it is in tracing back to the TRUE ORIGIN of contamination.

If the meat involved in this year’s eight recalls had not been sampled, the contaminated meat would have remained in commerce.  Since sampled meat is occasionally contaminated, we can conclude that unsampled meat is likewise contaminated on occasion.  Therefore, reduced numbers of recalls are no guarantee that all meat in commerce is safe.  CDC data shows a reduced incidence in consumer E.coli sicknesses, reliable proof that the industry has improved the overall safety of its products.  The industry is justifiably proud of improvements provided by a massive influx of capital investments in new equipment and methodologies.

Page one of this report briefly discussed the agency’s authority to implement enforcement actions at all “non-compliant” plants, regardless of size.  The ultimate success of agency enforcement actions, as well as the agency’s perceived authority to take action, must be concerned with two additional considerations:

  1. FSIS must have authority to engage plants which are the true origin of contamination.  The agency currently utilizes its enforcement authority fearlessly at the downline plants which are unwittingly purchasing previously contaminated meat.  The only perceived authority problem is witnessed at the large supplier plants.  Agency requests to increase authority solely at downline further processing non-slaughter grinding plants will continue to insulate the large slaughter plants from liability.  Therefore, any increased authority granted to FSIS must be married to two requirements:  (a) All testing must be designed to detect the true ORIGIN of contamination, and (b) FSIS must accept the uncomfortable responsibility to confront large plants when tracebacks reveal them to be the source of contaminated meat.  If the agency continues to sidestep delicate actions at large plants, our elected officials should give serious consideration to assigning all food inspection duties to one agency, namely, FDA. 
  2.  “Non-compliant” with what?  Currently, non-compliant with subjective standards which vary from plant to plant, even within the same district.  The absence of national standards and safe harbors is inconsistent with a “science-based” meat inspection system. 

If additional legal authority is desired, it must only be applied where plants are noncompliant with national standards emanating from scientific parameters, not ephemeral subjective opinions. 

CONCLUSION

HACCP is broken, requires mid-stream corrections, but is readily fixable.  FSIS continually reminds plants that science changes, while requiring plants to frequently reassess their HACCP plans and make changes.  Likewise, FSIS HACCP theory and implementation requires changes, many of which only time and field experiences could have revealed the need to resolve.

FSIS should reintroduce its previous regulations and national standards, coupled with its prerequisite scientific findings.  HACCP should remain, allowing individual plants the right to deviate from the agency’s standards when the plant can produce scientific reports from processing authorities which validate their request for personalized production procedures which vary from the agency’s standards.  Examples of new technologies which could justify departures from agency norms include interventions such as hide-on carcass washes, irradiation, steam pasteurization, chemical rinses, etc. Plants would still be required to perform hazard analyses, develop flow charts, and design HACCP plans.  Justifications for their HACCP decisions would now emanate from scientific studies shared with or obtained from FSIS.  This sharing of previously withheld information would finally allow both sides to work from the same page.  This would allow a true partnership to exist instead of the current adversarial relationship spawned by the agency’s forced implementation of a system devoid of national standards.

FSIS should conduct a substantial increase in microbiological sampling at plants of all sizes, including tests on carcasses, trim and finished products.  All lab sample results, whether conducted by the agency or industry, should be shared in real time with each other.  All sampling must include copious documentation of the true origin of meat being sampled, on the day of sample collection.  Additional monies to finance increased testing should be requested from Congress. All presumptive positive tests must be carried on to completion to determine confirmed test results. 

HACCP has resulted in an intellectual disenfranchisement which has alienated experienced agency personnel.  Instead of heeding erudite constructive criticism from loyal FSIS employees, FSIS had concluded that these employees are unwilling to change their old habits or embrace allegedly “science-based” inspection techniques.  Career advancement within FSIS now requires mandatory obedience and loyalty to enforce non-existent, or at best nebulous, regulations.  Agency publication of national standards will resolve this morale issue, and promote professionalism again.  It will also stanch the agency’s brain drain. 

Under HACCP, the agency’s focus on minimizing FSIS liability has spawned widespread food safety disenlightenment in what Dr. Garry McKee described as “the premier public health agency in America.”  This negative result from HACCP’s implementation is not only adverse to public health imperatives, but is the logical consequence of an agency’s desperate attempt to divorce itself from any liability resulting from food borne illnesses and outbreaks. 

Some industries may lend themselves to deregulation, but meat processing is not one of them.  Regulatory actions must be science based and objective, which HACCP is in theory only.

These comments are not intended to be all-inclusive, as many other issues currently face FSIS and the industry.  Risk-Based Inspection is an example, which if implemented improperly or without due consideration, could easily exacerbate HACCP’s unintended problems. 

Fortunately, current FSIS leadership under the able direction of Dr. Richard Raymond and Dr. Barbara Masters is committed to open and transparent policy discussions, and deserves our input and support.  As long as both the industry and FSIS are willing to accept responsibility for their actions, their partnership can successfully promote public health while allowing legitimate businesses to remain viable. 

If our partnership demands that policies and standards emanate strictly from truly scientific protocol, our international trade will also benefit. 

Dated this 31st day of December, 2006.

John W. Munsell
President, Montana Quality Foods & Processing
Manager, Foundation for Accountability in Regulatory Enforcement (FARE)
Miles City, MT