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Dear Editor,

I am responding to Brianna Leach’s article released by Food Safety News on May 26. She includes comments on the USDA’s implementation of its HACCP rule in 1995. For those who are unfamiliar with the term HACCP, it means Hazard Analysis Critical Control Point. What does that mean?  The HA in HACCP stands for Hazard Analysis, and the CCP in HACCP stands for Critical Control Point, a dynamic duo.  Each plant must initially perform a hazard analysis of their specific operations:  slaughter plants have hazards dramatically different than a jerky plant.  

HACCP is a preventative system designed to control significant identified hazards by means of validated process control measures. One way to “validate” process control measures, also known as “interventions”, is via microbial testing for pathogens.  

What is meant by the term “Critical Control Point”, aka as CCP?  A CCP is a point in the production process where controls can be utilized to Prevent, Eliminate, or Reduce (PER) pathogens to a less-than-detectable level. Thus, CCP’s such as cooking or irradiation will PER pathogens, thus qualifying the product and its production line for HACCP designation. Products such as fully-cooked hams, jerky and beef sticks conform to true HACCP requirements.

HACCP was developed by the Pillsbury Company in the 60’s in a joint effort with NASA and the Dept of Defense, both of which required consistently safe food for soldiers on the front line, and for astronauts in outer space. HACCP is science-based, in stark contrast with the USDA’s traditional inspection system which utilized an organoleptic inspection which relied upon sensory inspection of carcasses and finished product, utilizing visual, smell, and touching senses to detect unsafe meat.  The Jack in the Box outbreak caused by E.coli O157:H7, an invisible pathogen, revealed that pathogens cannot be detected organoleptically. Embarrassed by the JITB outbreak, USDA eagerly embraced the HACCP concept, and required all federally inspected plants to implement HACCP in a staggered order:  the largest plants (500+ employees) had an implementation deadline of January 26, 1998.  Small plants a year later, and very small plants another year later.

As long as USDA’s version of HACCP complied with true science, and remained true to Pillsbury’s initial scientific protocol, HACCP would be a remarkable addition to the agency’s reason for existence in the industry, promising safer meat.  Herein lies the rub.

USDA/FSIS required all meat plants to write their own customized HACCP Plans, specific to their unique operations. Plants producing Ready-To-Eat Jerky would have HACCP Plans dramatically different than plants producing raw ground beef. Nevertheless, all FSIS-inspected plants, regardless of their product line, were required to implement HACCP utilizing various HACCP categories.  In this example, plants producing raw ground beef must have a HACCP Plan called a “Raw, Ground HACCP Plan”. RTE jerky would require a plan with titles such as “Ready-To-Eat, Shelf Stable HACCP Plan”.  

Please remember that a Critical Control Point must utilize interventions to Prevent, Eliminate or Reduce pathogens to a less-than-detectable level. Let’s be honest here! Raw Meat & Poultry will never be consistently safe unless it is subjected to a “Valid” intervention, such as irradiation and full cooking. Which is precisely why NASA and the Dept of Defense require consistently safe products which had been subjected to what is called a “Kill Step,” such as full cooking or irradiation.  

Pillsbury developed HACCP specifically for products subjected to a Kill Step.  FSIS changed HACCP, requiring even raw meat & poultry to have HACCP Plans, full well knowing in advance that production of raw meat & poultry lacks a kill step. Thus, raw meat and poultry lacks a valid CCP.  Any HACCP Plan without a legitimate CCP is not HACCP! FSIS was fully cognizant of this fact, but still chose to require all meat plants to implement its bastardized version of HACCP.  

Prior to FSIS implementation of its HACCP rule, the agency relied heavily on its prestigious National Advisory Council on Microbiological Criteria for Food (NACMCF) for scientific input, ensuring that the agency’s HACCP Rule would be scientifically valid.  At least two members of the NACMCF vigorously opposed certain aspects of the agency’s rule as non-scientific.  They were microbiologists Gary Acuff and William Sperber.  Acuff is the Director of the Center for Food Safety and Professor of Microbiology within the Department of Animal Science at Texas A&M. A member of the NACMCF from 1992 – 1997, Acuff is currently a member of FDA’s Food Advisory Committee.  Sperber was and remains an international expert on HACCP, as he worked for Pillsbury from 1972 – 1995, helping refine true HACCP.  His unquestioned reputation is exemplified by the fact he served on the NACMCF for five terms.  No one on this globe was more closely familiar with true HACCP, for over two decades, than Sperber, who is now retired.  In his career, he worked for three major food companies: Best Foods, Pillsbury, and Cargill.  In 2000, he was appointed to the FAO/WHO roster of experts for microbiological risk assessments.  

Another point of major contention for some NACMCF members was FSIS’ misguided protocol for microbial testing on finished products.  My comments will focus merely on the agency’s abuse of true HACCP protocol.

Nevertheless, FSIS ignored scientific input from some members of the NACMCF, blindly forging ahead in its promotion of its faulty HACCP protocol. When questioned by Sperber, then-FSIS Administrator Tom Billy replied “We’ve changed HACCP, and there’s nothing you can do about it”. Rare candor! It also set the stage for future outbreaks emanating from raw meat & poultry, which was somehow produced without a kill step.  How could FSIS implement enforcement actions against raw meat & poultry plants which had alleged “failures” in their HACCP Plans? This awkward scenario was the result of the agency allowing such plants to author HACCP Plans which included CCP’s which the agency was fully cognizant of not complying with PER requirements. Welcome to FSIS-style HACCP!

More recently, FSIS has found a solution to this conundrum, changing the definition of a CCP.  In addition to the original requirements to Prevent, Eliminate or Reduce (PER) pathogens to a less-than-detectable level, the agency has conveniently added the term “Control.” An example would be temperature control.  Maintaining low temperatures will indeed control the environment, denying pathogens the opportunity to explode in numbers, merely by ensuring low temps. While temperature control is an immensely important tool in the plant’s portfolio of interventions, it is woefully inadequate and fully incapable of Preventing, Eliminating and Reducing pathogens! Folks, this is not science.

After I sold my plant in 2005, I established a foundation based on (1) representing the interests of legitimate small plants in their dealings with FSIS, and (2) communicating ideas to FSIS for common sense policy changes. During this time, I received numerous unsolicited communications from total strangers across America, including not only plant owners, but also disenchanted FSIS field personnel. They all related the same story, namely, FSIS intentional mistreatment of small plants.  Most criticism was centered on constantly changing agency HACCP requirements, not based in science, but on subjective, ephemeral personal opinions mandated by District Office (DO) personnel. In many cases, FSIS officials (CSO’s, EIAO’s, Compliance Officers and a plethora of DO HACCP technicians) were engaged in turf battles, all vying for ultimate authority while targeting small plants. One such official would visit a plant and mandate HACCP Plan changes, cautioning that failure to do so would guarantee a noncompliance report (NR), sometimes resulting in a Notice of Intended Enforcement (NOIE). Plant management dutifully make all mandated changes. Subsequently, yet another agency “expert” would arrive at the plant, and mandate that the recent changes be reversed, while mandating a new set of requirements, contradicting demands made by the previous agency expert. Unfortunately, this well describes FSIS style HACCP.

Exacerbating this dilemma is the fact that when a plant owner justifiably disagrees with inane requirements from the newest FSIS, the agency “rewards” the plant with a Food Safety Assessment (FSA), the results of which are guaranteed to harass the plant with subjective and frequently non-scientific mandates. Like the IRS auditor arriving at a business, stating “I’m from the IRS, and am here to help you.”

When FSIS targeted my plant in 2002, I had frequent communications with Rosemary Mucklow, executive director at the National Meat Association (NMA). A frequent topic we discussed was my ability to appeal agency decisions, including NOIE’s, and withdrawal of inspection personnel. Rosemary reminded me that during my appeal, my “lights would be out”. Rather than close my doors for an extended period, I acquiesced to agency demands merely to stay alive.

FSIS has free rein at small plants, knowing that such plants lack the deep pockets required to engage the agency with costly litigation, while lacking political clout. Thus, the agency plays with small plants like a cat plays with a captured mouse, enjoying the opportunity to abuse its power. In stark contrast, FSIS is paralyzed with fear of litigation emanating from the largest plants and their national organizations.  

The hypocrisy of this entire FSIS HACCP imposter is brought to light when we remember what HACCP and industry experts stated in official HACCP training sessions in 1996 and thereafter. I attended such sessions in Salt Lake City in February 1996 and again in Kansas City in March 1996, each time taking different employees for training. The primary speakers were from academia, all familiar with the HACCP concept. Interesting that at both sessions, a FSIS spokesman also gave a presentation describing the agency’s role under the HACCP rule. I well remember four statements from the FSIS representatives, who stated that under the HACCP rule, FSIS’ role would be:

1.  FSIS would no longer police the industry, but the industry must police itself.

2.  FSIS would jettison its previous command and control authority.

3.  Each plant must author its own HACCP Plan(s), reflecting on the unique conditions at each plant.  And, FSIS had no authority to tell a plant what must be in its HACCP Plans.

4.  FSIS would implement a “Hands Off” role at meat plants. 

All plant owners were incredulous at these agency publicly-revealed promises, ostensibly showing the agency’s desire to embrace deregulation. Only time would reveal the agency’s willingness to comply with any of their four promises.

Since 2000, when very small plants introduced HACCP, history has proven time and again that FSIS has aggressively  deep sixed all four promises above, at least at small plants. To argue otherwise would be sticking one’s head in the sand. FSIS forbids plants to engage in “Bait and Switch” marketing tactics.  Yet, FSIS has successfully baited the industry with its four public promises above in order to obtain industry “voluntary” compliance with FSIS-style HACCP, and then switched the agency’s operations back to its pre-HACCP authority. Few people grasp the agency’s deliberate misdeeds here.

Conversely, my contacts within the industry, and especially with FSIS personnel (many of whom are now retired) consistently state that for the most part, the agency has complied, to varying degrees, with all four promises with the largest packers. These transnational behemoths cannot be treated like the mouse by the cat, but constitute veritable powerhouses, not to be toyed with. I don’t criticize them for this.  Each large plant has invested considerable time and money over the years to attain the level they now enjoy.  The safety of their product has indeed improved since the JITB outbreak. They are sincerely committed to food safety, as failure to do otherwise would sicken and/or kill their own customers. My perception is that Brianna Leach has improperly portrayed the industry as being focused exclusively on profits.  I respectfully disagree.  

Another major failure in the FSIS bastardized version of HACCP is its microbial sampling protocol, which artificially targets its enforcement actions against downstream further processing plants, while insulating the large source packers from meaningful enforcement actions and agency monitoring oversight, and thus, for product liability. I will address this issue in subsequent comments. I doubt that Brianna Leach is personally familiar with problems inherent in the agency’s faulty sampling protocol.  She and Food Safety News readers need to know, as Paul Harvey used to say, “The Rest of the Story.”

— John Munsell

About the author: John Munsell ran a USDA-inspected meat plant for 34 years, which had been in the family for 59 years. Raised in Miles City, Montana and educated at Montana State University in Bozeman, MT, John returned to the family business subsequent to employment at Continental Oil and Target Stores. Having sold the business in 2005, John subsequently opened a deli/bakery at a local retail grocery store, and is currently employed by Miles Community College as a Biofuels/Renewable Energy Coordinator.

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