At the time FSIS required all federal plants to implement HACCP, our family-owned slaughter/processing plant had been in existence for 49 years, 24 years of which I had been the manager. Thus, I realized that if we were to continue to exist, that our entire staff would need to be fully on board the HACCP Express. So, I took three other employees to official HACCP training sessions in Salt Lake City in February 1996 and Kansas City in March 1996. Out of eleven full-time employees, four of us were HACCP-certified. We created HACCP Plans for Slaughter, Raw Not Ground, and Raw Ground. We were prepared. We were also indoctrinated in FSIS-style HACCP.
Trainers explained that a Critical Control Point (CCP) was a point in the production process whereby controls could be implemented to Prevent, Eliminate, or Reduce (PER) pathogens to a less-than-detectable level. We learned how to produce a thorough Hazard Analysis for every point in our production process. We were then provided a “Decision Tree” to be used to identify the areas in the production process which would be most advantageous to utilize CCP’s .
Each step in our HACCP Plan required a Hazard Analysis. Once the Analysis was performed, we had to ask ourselves if available interventions to utilize against the hazards would qualify for a CCP. If not, the Decision Tree required that we forward the Hazard(s) to the next production step, where we again used the Decision Tree to determine if an intervention could be listed as a CCP at that step, meeting PER requirements. Once we listed a CCP at one point, danger from the hazard (E.coli, Salmonella, etc) was theoretically removed from the product flow. Thus, we might not have to address the hazard(s) again in subsequent production steps.
All attendees at the session, who were authoring Raw HACCP Plans, were greatly puzzled how we could truthfully utilize the Decision Tree, because we knew that no interventions qualified for a true CCP, because they failed in meeting PER requirements. But we had also been told that FSIS would not allow us to write a HACCP Plan without at least one CCP. The PhD academicians who conducted the training sessions repeatedly reminded us that HACCP was “science based.” Thus, the Decision Tree forced us to identify plausible, valuable interventions at one or more points in the production process, even though they didn’t meet HACCP’s PER definition of a CCP. We were malleable in the hands of FSIS and the presenters, and did what we were instructed.
So, we all agreed amongst ourselves, with the full endorsement of the training presenters, that we simply had to choose one or more steps in which we would declare a CCP, full well knowing that the interventions were merely a control measure, not a CCP. If we refused to use CCP’s in Raw Plans, FSIS would not accept the Plan. It was a Catch 22 conundrum. It was at this point a cognizant dissonance occurred.
My focus was to create picture-perfect HACCP Plans, including questionable (albeit inadequate) CCP’s for my plant, which would withstand review from any agency official who would subsequently walk through my door. Thus, I initially created numerous CCP’s for our three HACCP Plans, to comply with “Decision Tree” requirements. After we implemented HACCP in 2000, numerous FSIS supervisors strongly suggested, to my surprise, that I should greatly reduce the number of CCP’s in my three Raw HACCP Plans. They explained that the numerous CCP’s were an unnecessary overkill, which would only create additional and time-consuming paper chase requirements for my staff, and for agency reviewers. They were correct!
Within a year after implementing HACCP, following many meetings with FSIS inspection personnel regarding HACCP-related decisions, we were all flummoxed by this HACCP ordeal.
We realized that something wasn’t right with FSIS-style HACCP, and our HACCP Plans, but couldn’t quite put our finger on it. Every time a new FSIS official appeared at our plant, typically a CSO, EIAO, or District Office big wig, it was suggested (aka “required”) to implement changes in our HACCP Plans. These changes would later be overruled/replaced by other agency employees who subsequently demanded we delete or change HACCP decisions required by previous FSIS field personnel. Failure to comply with this latest demand would automatically result in a NR or NOIE. None of us in the industry, or agency employees, dared suggest that FSIS-style HACCP was indeed not based on true science. Why rock the boat, which might endanger our business or agency careers?
We all came to realize we were living a lie, but couldn’t clearly delineate the lie. While FSIS HACCP decisions were frequently nonsensical, we nevertheless were unable to clearly reconcile this conundrum of pseudo-science agency demands. While FSIS and academia fully endorsed agency-style HACCP, we knew FSIS-style HACCP had inherent shortcomings, but we simply couldn’t explain why. Mental malaise set in for FSIS field personnel and company management.
Someone then provided me an article written by William Sperber, providing the first step for us to wrap our minds around the questionable foundations of FSIS-style HACCP. Sperber was an eminently qualified microbiologist. He had worked for Pillsbury from 1972-1995, helping to refine and improve initial HACCP protocol that Pillsbury had invented a decade earlier. He later became a global food safety expert for Cargill. Sperber had also been a member of the agency’s prestigious National Advisory Council on Microbiological Criteria for Food (NACMCF), serving five terms on the Council. Another well-known Council member was microbiologist Gary Acuff from Texas A & M, who has been hired numerous times by FSIS to train agency individuals such as EIAO’s. Thus, FSIS acknowledges that both men were incredibly talented and qualified.
NACMCF was tasked with providing advice to FSIS to help the agency author science-based HACCP requirements for the industry. During Council meetings, Sperber and Acuff expressed their opposition to many aspects of FSIS-style HACCP ideals, many centered on the inability for RAW products to have legitimate CCP’s. Their voices were ignored. Acuff resigned from NACMCF, while Sperber held out for several more years.
In the mid-90’s, FSIS quietly discontinued hosting NACMCF meetings. Thus, Sperber personally asked then-FSIS Administrator Tom Billy why no meetings were being held. Billy responded that the agency had already made its decisions on HACCP requirements, and did not want any more public input. Billy also told Sperber “We’ve changed HACCP, and there’s nothing you can do about it.” Rare agency candor indeed.
Sperber wrote several articles on the subject, detailing numerous other areas in which FSIS-style HACCP was not true HACCP, and was not science-based. He stated that true, original HACCP did not include end product testing, but did require substantial initial testing at numerous points in the production process, also known as “Process Control.” If a finished product tests positive for E.coli O157:H7, the results do not reveal which of the numerous steps in the process was/were out of control. Testing at a grinding plant does not identify the slaughter plant of pathogen origination. True HACCP required process control at each step of the production line, not simply at the point when the finished product became available. Sperber also stated that true, original HACCP did not require distinction of lots. Also, while temperature control is indeed an important control factor, it utterly fails the test to be named a CCP, although FSIS frequently suggests to plants that they name temperature control as a CCP because nothing else remotely plausible exists.
Sperber’s articles also defined the minimal control that government should have over plants which utilize HACCP protocol based in TRUE science. Such plants utilize a lethality/kill step, such as full cooking or irradiation, both of which are absent in raw products. Indeed, ready-to-eat products should always be safe to eat, having been exposed to a lethality step. Such plants qualify for deregulation. In stark contrast, raw products have not been exposed to lethality steps. Plants producing raw products thus qualify for much closer government oversight/regulation.
When FSIS originally described to industry players the agency’s revised role under HACCP in 1996, the agency publicly made the following four promises to the industry:
(1) Under HACCP, the agency would no longer police the industry, but the industry must police itself.
(2) The agency’s role under HACCP would be “hands off.”
(3) The agency would disband its previous command and control authority.
(4) Each business has the right to author its own customized HACCP plans, designed to reflect unique conditions which exist at the plant. And, FSIS would not have the right to demand what must be in HACCP Plans.
After HACCP was implemented by plants of all sizes, the agency has been grossly non-compliant with all four of their pre-HACCP promises, especially at small plants. History has shown time and again that after HACCP was implemented industry-wide, FSIS has unquestionably hyper-regulated the industry of small plants, which lack political influence or deep pockets to challenge intentionally faulty agency decisions. My favorite term for agency treatment of small plants is “hagride,” a verb meaning to torment and harass, especially with worry and dread. When “science” doesn’t work, rely on enforcement threats!
After reading Sperber’s articles, I’ve observed how the agency/academia HACCP tag team continues to discredit true science and original HACCP. As an example, after Jack In The Box experienced a 1993 outbreak from E.coli O157:H7-contaminated ground beef, the company formed a new food safety team. One industry magazine published an article about a requirement instituted by David Theno, a well-known, nationally-respected, and eminently qualified member of the new JITB team. The requirement was that any plant supplying patties to JITB must test one patty every 15 minutes. This requirement would certainly discourage any grinder that knew it had ongoing pathogen issues, while rewarding plants with high food safety standards. After being familiar with Sperber’s articles, I was dismayed with the industry and agency plaudits for this policy. While this policy places more responsibility on the originating grinder, the increased testing regimen still fails miserably in being a valid CCP.
Armed with these facts, the agency’s repetitious claim that the detection of pathogens is proof of a failure in a plant’s raw HACCP plan is disingenuous and specious. In stark contrast, the detection of pathogens in ready-to-eat products does indeed show a failure in that RTE HACCP plan. USDA/FSIS and public health officials have always cautioned consumers to properly handle and fully cook all raw foods, because such foods can be lethal. No one questions this undeniable fact. We will always find a certain incidence of pathogens in raw foods. Thus, how can the detection of pathogens in raw foods constitute a failure, when no legitimate CCP was ever in existence? While all meat plants share the goal of pathogen-free food, zero tolerance will only be accomplished via full cooking or irradiation, which by definition will not be found in raw products.
Quite candidly, any HACCP plan without a true, legitimate CCP is not HACCP.
Public health benefits greatly by the ability to identify the source of contaminated food, a goal aided by the development of PulseNet and improved sampling protocol. In spite of this, FSIS ardently avoided tracebacks to the origin of contamination the first decade of this century. During this time frame, FSIS’ Office of Field Operations (OFO) did not allow inspectors who collected ground beef samples for lab analysis to document source information on the meat being sampled. Under great pressure, FSIS finally relented, and published notices 58-10 and 06-13, frequently enabling a scientific identification of, and trace back to the true origin of contamination. Previously, OFO blithely placed all liability for contaminated meat against the destination plant which had innocently purchased meat already laced with invisible pathogens. During this unfortunate time in OFO history, public health and food safety suffered because OFO lacked the courage to implement enforcement actions at the true origin of contamination. So much for science.
Perhaps only in the past four years have audacious industry folks publicly commented on the obvious shortcomings in FSIS-style HACCP. Such brave folks are likened to archaic dinosaurs from the previous “poke and sniff,” organoleptically-dependent inspection system which lacked the capability to detect invisible bacteria such as E.coli O157:H7 and Salmonella. Such folks are depicted as being opposed to updated, modern science. What FSIS fails to acknowledge is that science does not change. Rather, our understanding and application of true science improves. Water will always be H2O, will never be H3O, in spite of FSIS’ ongoing claim that “science changes.” Whenever FSIS relies on science fiction and/or political science, public health suffers.
Especially in a democracy, the best treatment for deceit and sickness is sunlight — and free speech. FSIS assiduously avoids both. FSIS-style HACCP needs a midstream checkup if our top priorities are indeed food safety and public health.
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