HACCP'S Disconnect From Public Health Concerns
Upton Sinclair’s Book “The Jungle” in 1906 had far-reaching consequences, impacting the meat processing industry and USDA activities through today. “The Jungle” revealed the sordid sanitation conditions in the meat industry of his day, exposing an industry not capable of policing itself. His book energized President Theodore Roosevelt and Congress to pass the Federal Meat Inspection Act in 1906. Various modifications and revisions have transpired in the last one hundred years, the most recent of which (and perhaps the most serious) is known as Hazard Analysis Critical Control Point (HACCP). This paper will address the initial justification for and implementation of the HACCP ideal, which has numerous adverse implications for public health imperatives. Currently, Food Safety Inspection Service (FSIS) is the USDA department in charge of meat inspection.
When the Jack In The Box (JITB) outbreak occurred in 1993, four children died and hundreds of consumers were sickened. FSIS responded by mandating the meat industry implement HACCP as a “science based” method of preventing, eliminating or reducing the pathogen load in domestic meat plants. HACCP had originally been invented by Pillsbury in the 1960’s as their attempt to provide guaranteed safe and wholesome food for NASA usage. It is important to realize that Pillsbury authored HACCP on a “cost plus” contractual basis with the federal government, and was intended for use solely for ready-to-eat (RTE) food. FSIS attempt to force HACCP into the raw food system has met substantial difficulties. Elsa Murano’s comment that “There is no such thing as risk-free raw meat” was precisely correct. In spite of Elsa’s statement, FSIS still subscribes to its Zero Tolerance stance towards E.coli, in spite of admitting that raw meat carries risk.
FSIS introduced HACCP as a superior, “science-based” protocol for meat production, explaining that the meat inspection system during the JITB outbreak was “organoleptic” in nature, meaning the senses, such as sight, smell, touch, etc. E.coli was a newly emerging bacterium in the 90’s, and like other pathogens such as salmonella and Listeria, is invisible to the human eye. Therefore, new science-based meat production systems capable of detecting and removing new (and invisible) pathogens would be required to protect the consuming public.
FSIS publicly stated that the heart of HACCP’s “scientific” foundation was microbiological testing, which would reveal the presence of these microscopic pathogens. The agency promised that it would conduct substantial microbial testing at all plants under the HACCP umbrella, and that plants would likewise be expected to perform microbial tests on their own.
In several public hearings and during intensive industry training prior to HACCP’s implementation, FSIS personnel described HACCP in the following manner:
- Under the HACCP umbrella, FSIS’ involvement would be “Hands Off”.
- FSIS would no longer police the industry, but the industry must police themselves.
- FSIS would dissolve its previous command and control functions, to which all plants responded “Alleluia!”
- Each plant must write its own HACCP Plan, since no two plants are exactly alike.
- FSIS will not have the authority to tell plants how to write their HACCP Plans. Since national standards would be eliminated, the agency cannot require individual plants to comply with agency standards because under HACCP, one size does not fit all.
The two foundational premises on which HACCP was constructed were (a) prevention and (b) corrective actions to prevent recurrences. Prevention was ostensibly to be accomplished via plant-conducted Hazard Analyses, and implementation of Sanitation Standard Operating Procedures (SSOP’s), Good Manufacturing Practices (GMP’s), Pre-Requisite Programs, Supplier Certification, and numerous other programs. In the rare events when sanitation failures would be detected, Corrective Actions to prevent recurrences would then be implemented. Preventive and corrective action protocol constituted a remarkable improvement over the industry’s previous involvement prior to HACCP’s advent.
The beleaguered industry swallowed these delectable enticements hook, line and sinker. In less than 100 years since the passage of the Federal Meat Inspection Act, USDA unilaterally and voluntarily relinquished much of its congressionally-mandated authority back to the industry. FSIS’ promise to maintain a “Hands Off” non-inspection role in the industry should have raised red flags, but was outweighed by the ostensible advantages garnered from the promised substantial increase in scientific microbiological testing. Nevertheless, the debacle emanating from the JITB outbreak revealed that meat inspection required dramatic improvements, and modern-day “scientific” protocol was painted as the panacea to prevent recurrences of outbreaks.
On January 26, 1998, the largest plants were required to implement HACCP. Six days later, on February 1, 1998, FSIS issued Directive 10,010.1 which exempted qualified plants from agency-conducted testing. The big slaughter plants quickly qualified. This little-known fact, and its timely implementation, quickly revealed that the agency lacked the intestinal fortitude to conduct microbial testing at the large slaughter plants. Instead, the agency directed its testing at the smaller downline plants, the majority of which do not slaughter. As such, these plants exclusively rely on meat purchased from their large source slaughter suppliers.
It is imperative to realize that E.coli and Salmonella are “enteric” bacteria, which by definition means they emanate from within animals’ intestines, and by extension, proliferate on manure-covered hides. The downline, further processing plants which do not slaughter have no intestines or hides on their premises. Therefore, when E.coli or Salmonella are detected at these downline further processing plants, the detections quickly reveal that the source slaughter plants are successfully shipping pathogen-laden meat into commerce in containers bearing the official USDA Mark of Inspection.
Unfortunately, history has shown that when FSIS has detected enteric pathogens at these downline facilities, agency enforcement actions are almost exclusively directed at these victimized downline further processing plants, while virtually ignoring tracebacks to the true origin of contamination. Frequently victimized downline plants are charged with having multiple failures in their HACCP plan, and required to perform HACCP reassessments in order to prevent recurrences. At this juncture, the allegedly “science based” foundation of HACCP ruptures. As long as FSIS mandates corrective actions at the destination of pathogens, rather than at the origin of contamination, recurring production of pathogen-laden meat is virtually guaranteed. While the downstream plants fabricate a litany of actions which supposedly will prevent them from unwittingly purchasing previously contaminated meat from their suppliers in the future, the source plants which are guilty of introducing the contaminants continue operating as is, insulated from FSIS enforcement radar, and recurrences are inevitable.
Frankly, comparatively small downstream further processing plants are easier enforcement prey to FSIS than the large source slaughter plants. Small plants lack the political clout and financial wherewithal to engage the agency in protracted litigation, advantages enjoyed by the large, often multi-national slaughter behemoths. Exacerbating this situation is the consolidation witnessed in the meat industry in recent decades. The big four packers have slaughtered over 80% of feedlot cattle in recent years. With JBS-Swift’s purchase of National Beef and proposed capture of Smithfield’s cattle plants in recent weeks, industry consolidation will effectively be narrowed down to only three in this consumer-unfriendly oligarchy.
The agency’s rejection of pre-HACCP national standards has further aggravated the agency’s inability to protect public health, has eliminated agency consistency in enforcement actions, and has victimized downline plants the agency requires to concoct theoretically-correct HACCP decisions. In the absence of national standards, the thousands of inspectors and veterinarians no longer know what minimum standards should be required in order to produce wholesome food. Turf battles are rampant within FSIS ranks, confusion reigns supreme, and unnecessary disagreements saturate the inspector/plant management relationship. Identical problems shared by nearly-identical plants frequently result in diametrically opposite, frequently contradictory decisions made by FSIS under the “science based” HACCP umbrella.
In the ten years America has now endured HACCP, history has shown that FSIS primarily inspects paperwork, while avoiding inspecting meat in this HACCP-deregulated industry. Inspectors who previously monitored meat production lines are now frequently relegated to inspecting paperwork. Numerous plants which have suffered through the detection of contaminated meat (contaminated at their source supplier plants) undergo exhaustive FSIS scrutiny exclusively focused on (a) written HACCP Plans and (b) daily paperwork. Unwittingly, FSIS is admitting that contamination is caused by allegedly inadequate paperwork, or a missing paragraph in the plants’ HACCP Plans. Such absurdity is the logical consequence of placing primary oversight on paperwork, while ignoring the weightier importance of unsanitary meat production lines.
The credibility of individual plants’ HACCP Plans and related supporting programs is predicated on the plants’ ability to accumulate theoretically plausible scientific articles which describe how the plant is supposedly capable of production of consistently wholesome products. A superlative example was the conundrum revealed both prior to and subsequent after ConAgra’s 19.1 million pound recall of meat potentially contaminated with E.coli in 2002. Prior to the recall, ConAgra touted their multiple hurdle pathogen intervention system which had been independently validated to provide a 7-log pathogen reduction (99.99999% reduction), justifying the company’s claim that their carcasses were being “virtually sterilized”. FSIS accepted this laudable claim (in the absence of agency-conducted testing of course). The subsequent OIG investigative report issued in 2003 stated in part “Data was available to both ConAgra and USDA in the period prior to the recall that indicated that E.coli contamination was becoming a continuous problem (emphasis added) at ConAgra”. Another OIG statement was “Although animal feces on product was repeatedly observed(emphasis added) during production at ConAgra, USDA took no enforcement action”. The OIG report also stated “USDA had reduced its oversight short of what was prudent and necessary for the protection of the consumer”. Yet another statement was “USDA inspectors followed policies that effectively limited the documents the inspectors could review and the enforcement actions they were allowed to take”. Lastly, “USDA did not take enforcement action against ConAgra even though it continued to cite the plant for HACCP violations involving visible fecal contamination (emphasis added) of products”.
The ramifications are numerous, allowing FSIS no escape route. First of all, “visible fecal contamination” was no longer of interest to the agency for two reasons. First of all, the detection was accomplished via organoleptic methods (visual observation), an allegedly archaic throwback to meat inspection’s dark ages; thus, should be ignored. Secondly, the multiple hurdle pathogen interventions ostensibly removed ALL contaminants, allegedly “sterilizing carcasses”. Under HACCP’s insulation, FSIS has no concern with feces on carcasses, because plants have implemented pathogen intervention steps which apparently remove all contaminants, both visible and invisible. How can a plant with scientific proof that it sterilizes carcasses possibly be guilty of experiencing a “continuous problem” with E.coli contamination? These two sets of “facts” cannot be reconciled, at least under a truly scientific system. The 19.1 million pound recall balanced the scales. And, if animal fecal contamination was “repeatedly observed” by FSIS inspectors, why weren’t enforcement actions taken by the agency? Answer: FSIS must live up to its initial “Hands Off” restrictions, or be guilty of reneging on its promises to the large slaughter establishments.
There may be some industries which respond well to deregulation, but the food industry is not one of them.
A common question asked regarding these obvious deficiencies center around the agency’s blithe acceptance of the artificial restrictions placed upon it by HACCP. A closer inspection reveals the advantages FSIS enjoys by embracing the HACCP mentality. First of all, the “premier public health agency in America” has been allowed to semi-retire at the large slaughter plants. This has created a much more comfortable work place for an agency committed to avoiding delicate enforcement actions against the industry’s largest and most powerful players. Secondly, when contaminated meat is detected, FSIS can’t share any liability for meat which it had never inspected in the first place. While the Mark of Inspection states “USDA Inspected and Passed”, in all actuality the meat did indeed pass, but was not inspected. Thirdly, minimized inspection has allowed a reduction in inspector numbers, simplifying the agency’s desire to reduce its payroll budget while controlling and micro-managing inspector activities. Part and parcel of this is the agency’s desire to remove most authority from on-line inspectors, who otherwise would take aggressive actions against noncompliant slaughter plants which fail to remove fecal contaminants. Inspector ability to unilaterally move against obviously noncompliant plants has been eviscerated, so to speak.
Agency inability to move against plants is not industry-wide however. While FSIS has justified its semi-retirement status at the large plants, the agency responds by hagriding the small downline plants, creating a large reduction in small plants populations post-HACCP. Such agency-endorsed harassment of small plants is primarily accomplished via constant intensive “reviews” of small plants’ written HACCP plans and related plans. Since national standards have been unceremoniously jettisoned, inspectors lack a rational library of agency decisions from which logical decisions can be made when daily meat production questions arise. Decisions, as well as agency enforcement actions, thereby depend on subjective agency decisions which typically contradict other agency actions, as previously noted. Small plants which lack the clout to fight back against egregious FSIS actions are easily intimidated, and are forced to do as the agency mandates. The fact that this scenario makes a lie out of the initial agency promise that FSIS cannot tell plants how to write their HACCP Plans is of no import to an agency whose blessing is required for small plants to keep operating. Typical agency actions find that one inspector overrides the previous inspector’s mandates at a plant, requiring an immediate HACCP revision by plant management. A month later, another CSO/EIAO/FLS/District Office Inspector or any of a number of subsequent agency personnel visit the plant and require yet another major revision, under threat of NR’s, NOIE’s, or suspension in the event the plant objects. Once these changes are made, another inspector arrives, and promptly undoes all the previous erudite changes. This mess bespeaks a biased meat inspection system devoid of scientific underpinnings, designed to provide a PR image of an agency which is allegedly the consumer’s 24/7 ultimate protector. The agency’s consistent argument that it closed numerous plants the previous year never reveals how many of these plants were large, or small, an intentional agency oversight.
When adverse lab results occur at small plants, even at plants which do not slaughter, FSIS fearlessly accuses small plants with having failures in their HACCP Plans, and requires immediate reassessments. In stark contrast, when adverse lab test results are detected at large slaughter establishments, FSIS does NOT commence enforcement actions against the very plants where the contaminants originated. FSIS justifies this dichotomy because the noncompliant slaughter plants divert the meat to plants which fully cook the meat, which constitutes an effective kill step. The large slaughter plants, as well as FSIS contend that the testing regimen (a) successfully detected the pathogen, and (b) diverted it from the pipeline of raw meat, preventing shipment to the consuming public in raw form. Oddly, but understandably, the agency does not perceive these multiple recurrences of microbial positives as failures in HACCP Plans at the slaughter plants, but as proof that the slaughter plants’ HACCP Plans were successful, in that the pathogen was detected and diverted. As such, no corrective actions are being required at the slaughter plants which are allowed to continue operations unfettered by changes which would reduce the incidence of pathogens. However, the detection of pathogens at downline plants are automatically classified as “failures” by FSIS, even though the meat was withheld from commerce. Agency actions which are solely predicated on the size of the establishment (and its ability to demand fairness) do not qualify as “science based”. HACCP is NOT science based. Political science perhaps.
2002 was the perfect storm year for E.coli outbreaks and recalls. Both the agency and the industry responded via a number of initiatives which indeed reduced the appearance of the pathogen……….for awhile. The incidence of E.coli was dramatically reduced in 2003 and 2004, but advancements stalled in 2005 & 2006. Then, 2007 happened. Although there were no public health outbreaks of E.coli in 2006, a total of 13 reared their ugly heads in 2007. Also, the number of recalls equaled the previous annual record. The potential reasons for the unexplained eruption of E.coli in 2007 were as numerous as the authors who proffered their conjectures. It is unlikely that one factor, such as the use of ethanol’s distillers grains or drought conditions is the sole guilty culprit. However, nine years of FSIS’ unwillingness to organoleptically observe large slaughter plant operations, while refusing to collect a meaningful incidence of microbial tests at such plants, while adroitly avoiding requiring necessary corrective actions at these source plants merely swept visible problems under the carpet. In 2007, there was no room left under the carpet, which commenced belching out the cover-up in 2007.
America’s consumers are reaping what FSIS has sown since HACCP’s inception. As long as the ORIGIN of enteric pathogens benefit from lack of efficacious agency oversight, recurring outbreaks and recalls should be anticipated. Recurrences are also the result of FSIS’ unwillingness to proactively engage in policies which require tracebacks to the ORIGIN of contamination. This author has contacted numerous downline, non-slaughter plants which have suffered recalls the last six years. Results have been fairly unanimous, in that FSIS investigative efforts have shown little or no interest in determining the true origin of E.coli contamination. And, the agency is perfectly content in requiring the victimized downline further processing plants to implement corrective actions to prevent their future purchase of previously-contaminated meat. This is an exercise in futility. Regardless of the thoroughness of purchase specifications required by downline plants, and in spite of file cabinets overflowing with annual certifications and certificates of analysis provided by source supplier slaughter facilities, these downline plants continue to unwittingly purchase previously-contaminated meat. These contaminants are invisible, and arrive in containers bearing the USDA Mark of Inspection. If truth in advertising laws were required in the meat industry, the Mark would be replaced with a Mark simply stating “Produced at HACCP Plant # 99999”.
Excoriating FSIS laziness and revealing HACCP’s problems are easy tasks, but remedying the obvious problems is more difficult. The following alternatives should be pursued if meat inspection’s primary focus is protecting public health:
- All food inspection should be delegated to one agency, which must be divorced from USDA and FDA, and from current bureaucrats who endorse the HACCP style of non-inspection.
- The new agency must aggressively embrace a “Hands On” inspection protocol.
- The new agency must implement an enormous increase in agency-conducted microbial samples, especially at slaughter plants, of all sizes. Because of the risk derived from plants killing thousands of beef daily, impacting national and international consumers, large plants must be closely scrutinized and tested numerous times daily.
- Congress must provide increased funding to hire additional inspectors, and to enable a huge increase in microbial sampling. If FSIS would implement a huge increase in microbial testing at the large slaughter plants, AND publicly release all lab results, within six months all Americans would know where 2007’s ugly outbreaks emanated.
- Inspection must be focused on meat production lines, placing less emphasis on paper flow (which does NOT introduce contaminants). Consumers are best protected by an agency dedicated to meat inspection, not paperwork inspection.
- The new agency must be empowered to police the industry.
- Meat plants should still utilize HACCP Plans, because such plans are an effective management tool, providing closer control over operations.
- Corrective actions must be focused on plants where contaminants are introduced, rather than at victimized downstream plants where contaminants are detected.
- Providing required authority to the new agency can lead to abuses. Therefore, well-defined appeal rights must be clearly delineated, and legal recourse rights must be provided to plants subjected to unethical agency abuse. A balance must be maintained.
- National standards must be written to prevent inefficient use of inspector and plant management time. The wheel only needs to be invented one time.
- College-trained veterinarians must be liberally interspersed throughout meat inspection activities. Individuals with scientific backgrounds portend healthier foods in the pipeline than bureaucrats with political science focuses.
- E.coli must be considered as an adulterant, wherever it is found. Currently, FSIS does not consider E.coli on boxed beef to be an adulterant. Again, political science reigns.
- The new agency must incorporate organoleptic inspection methodologies in the new inspection system. Throwing the baby out with the bathwater serves no one, except FSIS and the large slaughter plants.
While this is not an exhaustive delineation of all historical incidents which have occurred since meat inspection was initiated, nor provide a complete list of improvements required, it does provide a meaningful starting point from which long-overdue changes in meat inspection can be discussed. It was specifically intended to reveal HACCP’s anti-scientific bias, coupled with remedial alternatives.
Meaningful meat inspection should be a win-win situation: consumers should anticipate the likelihood of safe food, and meat plants which proactively implement wholesome production practices can operate in an industry where non-compliant plants unwilling to clean up their act are forced from the marketplace. Current agency policies insulate the large slaughter plants from accountability, while insulating the agency from liability. Consumers pay the price. This is a win-lose proposition, which must accept corrective action to prevent recurrences.
Submitted this 20th day of March, 2008
John W. Munsell
Manager, Foundation for Accountability in Regulatory Enforcement
Miles City, Montana