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Let’s Not Forget HACCP

Let’s not forget the Hazard Analysis and Critical Control Points system — HACCP — what it is, why it was developed and what its role truly is in regard to food safety.  HACCP was developed in the 50s because the food safety experts knew that you could not “test” food safety into food.  It was understood at that time that HACCP, coupled with strong hazard interventions was and continues to be the most effective way to produce safe food. HACCP was used very effectively by the canned food and ready-to-eat industry to produce safe food products.  

We all know what happened after the ground beef E. coli O157:H7 outbreak in 1993.  USDA and the food industry began the rapid movement toward mandatory HACCP.  It was obvious in 1993 that the voluntary approach to HACCP was not working — less than 5% of the meat and poultry industry had implemented HACCP.  During the early stages of the mandatory implementation there was much confusion within the government and the industry.  Almost all of the HACCP expertise resided in the ready-to-eat and canned food sectors.  Neither FSIS, USDA nor the raw side of the meat and poultry industry had sufficient knowledge about HACCP and this was the reason for the formation of the International HACCP Alliance in 1994–to standardize how we trained personnel in the HACCP arena.

I believe that, as mandatory HACCP was implemented, some key errors were made. We began going down two paths, which are actually contradictory to one another. One path is HACCP, with its effective interventions coupled with science-based validation systems, while the other path tries to “test” food safety into food. The second path essentially ignores the key reason that HACCP was developed. It will be impossible to overcome the tremendous problems associated with sampling food that contains non-uniformly distributed bacteria. The sample size would have to be so large that it would be unrealistic to sample sufficiently and have a high probability of finding the pathogen if it is present.

By forcing the meat and poultry industry to go down both paths, we have diverted huge resources to the wrong type of testing and away from the development and implementation of more effective farm-to-market interventions. The industry should be applauded for what it has accomplished over the past 17-18 years. Just think what could have been accomplished if the end product testing resources were used to produce safe food. Don’t let me give you the impression that all testing is not effective. Every HACCP plan should include strong testing programs to “validate” the interventions used in the HACCP plan.

So now we are about to have six more adulterants. We still do not know the true risk of the six Shiga-toxin producing E. coli – STECs – nor do we have proven tests to be used in a commercial setting.  So, my regret is that we continue to go down the “non-science” based path that will divert resources that could be used to produce safer food.

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Dr. H. Russell Cross has more than 35 years of management experience, holding numerous positions in government, academia, and the private sector. Dr. Cross currently is Professor and Interim Head in the Department of Animal Science in the College of Agriculture and Life Sciences at Texas A&M University. He most recently served as Executive Vice President for Operations and Chief of Staff. His service in government included the role of Administrator of USDA’s Food Safety and Inspection Service under Presidents Bush (41) and Clinton. Dr. Cross also pioneered the International HACCP Alliance, serving as its founder and Executive Director. The International HACCP Alliance represents 24 food associations, 40 universities and the governments of 13 countries.

© Food Safety News
  • Joe R.

    The FDA has been very adamant in emphasizing proactive food safety policies yet they continue to put in place major regulations that are reactionary in nature. The new testing requirements for the six STEC strains is an example of that. When will they make the switch to the this “proactive” approach we keep hearing about and will the resources be available to implement it?

  • Dr. Cross, I share “some” of your enthusiasm for HACCP, especially when we apply HACCP to fully-cooked, RTE foods which are indeed consistently safe. Raw meat is not. FSIS has intentionally bastardized true HACCP, which may be a point you want to make without publicly admitting it.
    In your third paragraph above, you refer to [USDA-style]HACCP going down two contradictory paths in the 90’s, one being validation, the other testing. Yet you stated in the last sentence in the next-to-last paragraph “Every testing program should include strong testing programs to validate interventions used in the HACCP plan”. This statement reveals that the two allegedly contradictory paths are actually complementary because of FSIS’ current focus on validation.
    First of all, safe food is not made in raw plants with HACCP. However, HACCP plus prerequisite programs can greatly benefit the goal of safe food. FSIS’ mantra continues to be the need for CCP’s which would ostensibly produce safe meat. One CCP FSIS required of me ten years ago was to include a CCP consisting of testing incoming product in my receiving program. So, before I could process boxed beef I purchased from source slaughter plants, I had to microbially test it first. The vet at my plant argued with the Technical Service Center that such testing does not qualify as a CCP, because the testing would not Prevent, Eliminate, or Reduce pathogens to an undetectable level. But, FSIS won that argument, as it has countless times in other plants because the agency simply has nowhere else to hide but behind its bastardized HACCP apron.
    Little has changed in the last ten years. I’m sure you’ve read the agency’s Validation guidance letter issued March 19, 2010. The bottom line of that letter was the need for downstream, further processing plants to test (a) incoming meat, and (b) finished product. Essentially, FSIS acknowledged that it is fully cognizant that the source slaughter plants continue to ship into commerce an unacceptably high amount of pathogen-laden meat. So, the agency solution to this obvious public health dilemna is to require downstream entities to detect invisible pathogens in incoming meat, and remove it from the food chain. Let the horses out of the barn, only to attempt to find them out in commerce somewhere. This isn’t Pillsbury HACCP! But it is FSIS-style HACCP.
    Dr. Cross, a sizeable increase of agency & industry testing at all slaughter plants would quickly reveal which plants’ HACCP Plans have recurring failures. Adverse lab results would reveal that one foundation of HACCP, which is Prevention, regularly fails at the slaughter plants. And it always will, because these plants produce raw meat, without irradiation. Prevention must be focused at the SOURCE, but FSIS disagrees with me on this. Instead, FSIS policies slyly create the need for downstream plants to not only perform the Prevention step, but also implement another part of HACCP’s foundation, which is Corrective Actions.
    Dr. Cross, you know that FSIS allows slaughter plants to ship into commerce intact cuts which are surface-contaminated with E.coli O157:H7. This alone reveals that FSIS has jettisoned the initial Pillsbury HACCP Plan, which requires consistently safe food to be shipped into commerce. Since FSIS blithely allows slaughter plants to ship O157:H7 into commerce, the agency will also allow the source slaughter plants to ship into commerce intact cuts surface-contaminated with the Big Six non-O157:H7 STEC’s. I get the impression from your article above that you don’t want the industry to test for the new Big Six STEC’s. Well, maybe just the further processing plants. But not the source slaughter plants?
    AT a public conference in Chicago on Sept 17, 2008, Dr. Dan Engeljohn’s powerpoint included one slide in which the agency stated that if a plant has 3.3% positives on N-60 samples of trim, that 3.3% would NOT potentially evidence insanitary conditions, thus would not qualify for an agency “Event Day”. Dr. Cross, now cogitate on that for awhile! The FSIS mandate for Zero Tolerance now only applies to downstream further processing plants, while the agency turns a blind eye at slaughter plants which experience 3% or more of adverse lab results. Hell hath no fury like FSIS when it detects E.coli O157:H7 at a grinding plant. And, when agency verification sampling reveals H7 at a grinding plant, even though the grinding plant has only one supplier, FSIS refuses to perform Tracebacks to the source. (As per the agency’s request to OMB last Thursday, this malpractice may soon end). In these cases, FSIS requires the grinding plant to reassess its HACCP Plan, and implement corrective actions to prevent recurrences…..while FSIS does nothing at the source plant.
    Dr. Cross, I respectfully suggest that FSIS-style HACCP is a Hoax, which has benefitted the largest plants with deregulation, while hyper-regulating the smallest plants.
    Dr, could you tell me what the International HACCP Alliance’ stand is on these questions:
    1. Is Zero Tolerance achievable at slaughter plants?
    2. Is Zero Tolerance achievable at downstream further processing plants, in their raw products?
    3. Does the Alliance endorse the right of slaughter plants to ship into commerce intact cuts which are surface-contaminated with E.coli O157:H7, and now the other Big Six?
    4. Should slaughter plants be required to implement Prevention and Corrective steps?
    5. Or, should Prevention and Corrective actions be required solely at downstream further processing plants?
    6. Can interventions which do not Prevent, Eliminate, or Reduce contaminants to an undetectable level be listed as a CCP?
    7. If not, should such interventions be covered in Prerequisite Programs?
    8. Is Validation to be primarily accomplished only at the downstream further processing plants, insulating the source slaughter plants from accountability?
    9. Since Validation at downstream plants is best accomplished via microbial Testing, why do you state that Validation and Testing are two opposing paths?
    10. How can Raw Meat & Poultry plants possibly qualify for Pillsbury-style HACCP?
    I apologize if you feel I am putting the cross hairs on you, but after all, you authored this pro-FSIS Style HACCP article. The ten questions above have been hurled at FSIS in recent years, with precious few replies. As long as the International HACCP Alliance fails to expose failures in the agency’s HACCP Hoax, ongoing outbreaks and recurring recalls are virtually guaranteed.
    Plants producing fully cooked meats, subjected to a kill step, truly qualify for HACCP, liberating such plants from intensive FSIS scrutiny, or deregulation. Frankly, plants producing raw meat & poultry do NOT qualify for deregulation. In such raw plants, FSIS should maintain its old “Hands On” stance, with authority to police the industry with command and control. However, raw plants have a tool which could qualify them for deregulation. No, it’s not interventions, which claim theoretical ability to sterilize carcasses. Instead, it is testing of carcasses, intact cuts, trim and ground beef which can prove (VALIDATE) the consistent success the plant has in producing sanitary meat.
    Dr. Cross, perhaps we are in full agreement on the above points, but unlike you, I lack the political correctness to claim the emperor is wearing clothes. FSIS ain’t wearing clothes when it comes to validating the scientific basis of its HACCP Hoax. Until FSIS is willing to admit the ugly truth, consumers will continue to be sickened. And the International HACCP Alliance should not be expected to play by FSIS rules.
    John Munsdell

  • Dr. Cross, I failed to mention one point earlier today until I refreshed my memory of initiatives which you commenced when FSIS Administrator.
    You stated in your first paragraph above that HACCP was developed because food safety experts knew that you cannot “test” food safety into food. I fully agree! Test results alone, absent aggressive agency enforcement actions against the plants which INTRODUCED pathogens into our food, will utterly fail in improving public health. Test results reveal the ugly truth of hot meat, which FSIS has tacitly ignored when confronted with advese lab test results. Armed with ugly microbial test results, FSIS aggressively implements harsh enforcement actions against the victimized downstream further processing plants, while insulating the source slaughter plants from accountability.
    Regarding refreshing my memory: I recall that “Pathogen Baseline Testing” was implemented when you were FSIS Administrator. I also remember that opposition to your baseline testing idea contended that since pathogens are present at low levels, unless there is some technology to eliminate pathogens, testing to establish a base line would only lead to end product testing. While end product testing has the ability to detect unsafe meat, and allowing it to be removed from the food chain, end product testing typically does NOT reveal where and how the meat was contaminated. End product testing does not allow us to identify that point on the kill floor which has problems which caused E.coli to be left on carcasses in the first place. If a downstream grinder’s ground beef lab test is positive, we have absolutely no idea where corrective actions should be implemented.
    Who cares? FSIS doesn’t.
    Anyway, is my memory correct? Didn’t the agency implement “Pathogen Baseline Testing” when you were the Administrator? Why then are you now minimizing testing’s importance? Which of the two roads are you recommending we travel: (1) testing, or (2) validation?
    John Munsell

  • Dr. Cross, I share “some” of your enthusiasm for HACCP, especially when we apply HACCP to fully-cooked, RTE foods which are indeed consistently safe. Raw meat is not. FSIS has intentionally bastardized true HACCP, which may be a point you want to make without publicly admitting it.
    In your third paragraph above, you refer to [USDA-style]HACCP going down two contradictory paths in the 90’s, one being validation, the other testing. Yet you stated in the last sentence in the next-to-last paragraph “Every testing program should include strong testing programs to validate interventions used in the HACCP plan”. This statement reveals that the two allegedly contradictory paths are actually complementary because of FSIS’ current focus on validation.
    First of all, safe food is not made in raw plants with HACCP. However, HACCP plus prerequisite programs can greatly benefit the goal of safe food. FSIS’ mantra continues to be the need for CCP’s which would ostensibly produce safe meat. One CCP FSIS required of me ten years ago was to include a CCP consisting of testing incoming product in my receiving program. So, before I could process boxed beef I purchased from source slaughter plants, I had to microbially test it first. The vet at my plant argued with the Technical Service Center that such testing does not qualify as a CCP, because the testing would not Prevent, Eliminate, or Reduce pathogens to an undetectable level. But, FSIS won that argument, as it has countless times in other plants because the agency simply has nowhere else to hide but behind its bastardized HACCP apron.
    Little has changed in the last ten years. I’m sure you’ve read the agency’s Validation guidance letter issued March 19, 2010. The bottom line of that letter was the need for downstream, further processing plants to test (a) incoming meat, and (b) finished product. Essentially, FSIS acknowledged that it is fully cognizant that the source slaughter plants continue to ship into commerce an unacceptably high amount of pathogen-laden meat. So, the agency solution to this obvious public health dilemna is to require downstream entities to detect invisible pathogens in incoming meat, and remove it from the food chain. Let the horses out of the barn, only to attempt to find them out in commerce somewhere. This isn’t Pillsbury HACCP! But it is FSIS-style HACCP.
    Dr. Cross, a sizeable increase of agency & industry testing at all slaughter plants would quickly reveal which plants’ HACCP Plans have recurring failures. Adverse lab results would reveal that one foundation of HACCP, which is Prevention, regularly fails at the slaughter plants. And it always will, because these plants produce raw meat, without irradiation. Prevention must be focused at the SOURCE, but FSIS disagrees with me on this. Instead, FSIS policies slyly create the need for downstream plants to not only perform the Prevention step, but also implement another part of HACCP’s foundation, which is Corrective Actions.
    Dr. Cross, you know that FSIS allows slaughter plants to ship into commerce intact cuts which are surface-contaminated with E.coli O157:H7. This alone reveals that FSIS has jettisoned the initial Pillsbury HACCP Plan, which requires consistently safe food to be shipped into commerce. Since FSIS blithely allows slaughter plants to ship O157:H7 into commerce, the agency will also allow the source slaughter plants to ship into commerce intact cuts surface-contaminated with the Big Six non-O157:H7 STEC’s. I get the impression from your article above that you don’t want the industry to test for the new Big Six STEC’s. Well, maybe just the further processing plants. But not the source slaughter plants?
    AT a public conference in Chicago on Sept 17, 2008, Dr. Dan Engeljohn’s powerpoint included one slide in which the agency stated that if a plant has 3.3% positives on N-60 samples of trim, that 3.3% would NOT potentially evidence insanitary conditions, thus would not qualify for an agency “Event Day”. Dr. Cross, now cogitate on that for awhile! The FSIS mandate for Zero Tolerance now only applies to downstream further processing plants, while the agency turns a blind eye at slaughter plants which experience 3% or more of adverse lab results. Hell hath no fury like FSIS when it detects E.coli O157:H7 at a grinding plant. And, when agency verification sampling reveals H7 at a grinding plant, even though the grinding plant has only one supplier, FSIS refuses to perform Tracebacks to the source. (As per the agency’s request to OMB last Thursday, this malpractice may soon end). In these cases, FSIS requires the grinding plant to reassess its HACCP Plan, and implement corrective actions to prevent recurrences…..while FSIS does nothing at the source plant.
    Dr. Cross, I respectfully suggest that FSIS-style HACCP is a Hoax, which has benefitted the largest plants with deregulation, while hyper-regulating the smallest plants.
    Dr, could you tell me what the International HACCP Alliance’ stand is on these questions:
    1. Is Zero Tolerance achievable at slaughter plants?
    2. Is Zero Tolerance achievable at downstream further processing plants, in their raw products?
    3. Does the Alliance endorse the right of slaughter plants to ship into commerce intact cuts which are surface-contaminated with E.coli O157:H7, and now the other Big Six?
    4. Should slaughter plants be required to implement Prevention and Corrective steps?
    5. Or, should Prevention and Corrective actions be required solely at downstream further processing plants?
    6. Can interventions which do not Prevent, Eliminate, or Reduce contaminants to an undetectable level be listed as a CCP?
    7. If not, should such interventions be covered in Prerequisite Programs?
    8. Is Validation to be primarily accomplished only at the downstream further processing plants, insulating the source slaughter plants from accountability?
    9. Since Validation at downstream plants is best accomplished via microbial Testing, why do you state that Validation and Testing are two opposing paths?
    10. How can Raw Meat & Poultry plants possibly qualify for Pillsbury-style HACCP?
    I apologize if you feel I am putting the cross hairs on you, but after all, you authored this pro-FSIS Style HACCP article. The ten questions above have been hurled at FSIS in recent years, with precious few replies. As long as the International HACCP Alliance fails to expose failures in the agency’s HACCP Hoax, ongoing outbreaks and recurring recalls are virtually guaranteed.
    Plants producing fully cooked meats, subjected to a kill step, truly qualify for HACCP, liberating such plants from intensive FSIS scrutiny, or deregulation. Frankly, plants producing raw meat & poultry do NOT qualify for deregulation. In such raw plants, FSIS should maintain its old “Hands On” stance, with authority to police the industry with command and control. However, raw plants have a tool which could qualify them for deregulation. No, it’s not interventions, which claim theoretical ability to sterilize carcasses. Instead, it is testing of carcasses, intact cuts, trim and ground beef which can prove (VALIDATE) the consistent success the plant has in producing sanitary meat.
    Dr. Cross, perhaps we are in full agreement on the above points, but unlike you, I lack the political correctness to claim the emperor is wearing clothes. FSIS ain’t wearing clothes when it comes to validating the scientific basis of its HACCP Hoax. Until FSIS is willing to admit the ugly truth, consumers will continue to be sickened. And the International HACCP Alliance should not be expected to play by FSIS rules.
    John Munsdell

  • Dr. Cross, I failed to mention one point earlier today until I refreshed my memory of initiatives which you commenced when FSIS Administrator.
    You stated in your first paragraph above that HACCP was developed because food safety experts knew that you cannot “test” food safety into food. I fully agree! Test results alone, absent aggressive agency enforcement actions against the plants which INTRODUCED pathogens into our food, will utterly fail in improving public health. Test results reveal the ugly truth of hot meat, which FSIS has tacitly ignored when confronted with advese lab test results. Armed with ugly microbial test results, FSIS aggressively implements harsh enforcement actions against the victimized downstream further processing plants, while insulating the source slaughter plants from accountability.
    Regarding refreshing my memory: I recall that “Pathogen Baseline Testing” was implemented when you were FSIS Administrator. I also remember that opposition to your baseline testing idea contended that since pathogens are present at low levels, unless there is some technology to eliminate pathogens, testing to establish a base line would only lead to end product testing. While end product testing has the ability to detect unsafe meat, and allowing it to be removed from the food chain, end product testing typically does NOT reveal where and how the meat was contaminated. End product testing does not allow us to identify that point on the kill floor which has problems which caused E.coli to be left on carcasses in the first place. If a downstream grinder’s ground beef lab test is positive, we have absolutely no idea where corrective actions should be implemented.
    Who cares? FSIS doesn’t.
    Anyway, is my memory correct? Didn’t the agency implement “Pathogen Baseline Testing” when you were the Administrator? Why then are you now minimizing testing’s importance? Which of the two roads are you recommending we travel: (1) testing, or (2) validation?
    John Munsell

  • Mike Mychajlonka, Ph. D.

    I agree with Dr. Cross and commentator “Joe R.” that to trumpet HACCP as the path to salvation and then require testing of a new class of pathogenic adulterants seems contradictory. I also agree with Mr. Munsell when he asks why the facilities causing the problem are not held to their responsibilities, only the downstream processors. Still, there are things about this matter that still puzzle me. For example, has the regulation calling for validation also included stipulations on the analytical sensitivity that must be met by such testing? Have regulators indicated a confidence limit and error tolerance with which such testing is to be done? If the confidence limit is tight and the error tolerance low, who is going to pay for replicate testing on all those samples? My last point is in response to Mr. Munsell’s dismissive reference of: ” . . . interventions, which claim theoretical ability to sterilize carcasses” I assume you are referring to radiation exposure, which American and European consumers have repeatedly rejected. Nevertheless, I would like to ask how has it come to pass that it is now possible to pasteurize a raw egg, intact, in its shell (and without radiation) but it is not, apparently, possible to pasteurize a cut of raw meat?

  • Mike, your points and questions are erudite! Since I read your comments last night, sleep has evaded me, because your questions MUST be answered. Not possible with a few brief all-encompassing conclusions for which no justification is provided. This will be lengthy, but I contend, required.
    You hit the nail on the head when focusing on the agency’s perceived need for additional microbial sampling, realizing that HACCP was trumpeted by FSIS as our salvation. Mike, you won’t like the truth.
    In the mid-90’s, when FSIS was designing its style of HACCP, then-Administrator Tom Billy told a member of the agency’s NACMCF “We are changing HACCP, and there’s nothing you can do about it”. Mike, changing it from What?
    Pillsbury invented HACCP, commencing in 1959, in partnership with NASA and the Dept of Army, both of whom needed consistently safe, ready-to-eat food. Imagine an astronaut vomiting and suffering diarrhea in the weightlessness of outer space. Pillsbury’s initial, and true, HACCP protocol was designed for plants making fully-cooked, ready-to-eat food which was consistently safe. Pillsbury-style HACCP required HACCP plants to test safety into every single component of its food production line. For example: let’s say a food system had ten segments. Plants would have to initially perform a multitude of microbial tests at each of the 10 segments, to ensure that EACH SEGMENT could individually prove that it was safe, and did not introduce contamination into the product or allow pre-existing contamination to remain. Pillsbury called this “Process Control”, where each process, or step, had to stand by itself and prove that it was safe. Once the entire process continually proved that each process, and the entire process, produced safe food, only at that time could the plant qualify for HACCP consideration. Once validated, we can see that the plant truly qualified for deregulation: no need for intensive gov scrutiny of such RTE plants. Many contemporary meat plants, or portions thereof, truly qualify for HACCP today, including products such as jerky, beef sticks, pre-cooked turkey breasts and roast beef for deli sandwiches, etc. These plants truly police themselves, and proudly sell such products as safe, and ready to eat. Pillsbury always intended HACCP to be a voluntary program, exclusively designed for only those plants willing to invest in production protocol which can be proven to consistently produce safe food.
    So, how did FSIS and Tom Billy “CHANGE” HACCP? First of all, FSIS mandated that every USDA-inspected (and state-inspected) plant implement HACCP. Therefore, all plants producing RAW meat & poultry likewise had to implement HACCP, even though we all know that raw meat & poultry carries risk…..unlike RTE products. FSIS further complicated things by proudly proclaiming its “Zero Tolerance” for fecal, injesta & milk. Good luck! Raw meat, absent a kill step, will never be free from enteric bacteria. FSIS knew better, but its Zero Tolerance declaration had a good sound byte.
    After the JITB outbreak in 1993, FSIS announced that the industry and the agency must change to the HACCP protocol. In the mid-late 90’s, a multitude of official HACCP Training Sessions were held across the country, educating and training meat plant officials of this new protocol. The sessions were conducted by academicians familiar with HACCP, FSIS representatives, and industry officials. I attended two of these intensive sessions, in Salt Lake City and Kansas City. The trainers all stated that HACCP constituted a big imporovement over the agency’s previous meat inspection system, primarily because HACCP would be “Science Based”. In the two sessions I attended, the audience demanded an explanation of what “Science Based” meant. Two answers were provided:
    1. Under HACCP, each plant would police itself, and FSIS would no longer police us.
    2. Under HACCP, plants and the agency both would collect microbial samples for lab analysis to detect the presence of pathogens, detection which was not possible under the agency’s previous organoleptic system. When I implemented HACCP in 2000, my family-owned plant had never collected one microbial sample in its previous 54 years of existence. During those 54 years, FSIS had collected few, IF ANY, such samples either. Fortunately, 4 agency samples of ground beef at my plant all revealed the presence of E.coli O157:H7 in January & February 2002. Agency reaction to those 4 positives is a story all its own. Suffice it to say that microbial sampling was the heart of FSIS-style HACCP. Well, was this the change to which Tom Billy referred?
    One man who was instrumental in developing and refining Pillsbury’s true HACCP system was microbiologist Dr. William Sperber, who worked at Pillsbury from 1972 – 1995. Interestingly, Dr. Sperber has written several articles in recent years, defining the substantial differences between true HACCP & FSIS-style HACCP. Consider this remark from an article entitled “Happy 50th Birthday to HACCP”, published in the Dec 2009/Jan 2010 edition of Food Safety Magazine:
    “It is comforting to note that the HACCP pioneers, beginning 50 years ago, established features of HACCP that have not changed. These are the following:”
    The last of the 3 items was this: “It does not rely on product testing or lot acceptance criteria”.
    Mike, this statement is heinous heresy to FSIS, which places a higher emphas on product testing every year. Indeed, as Tom Billy said, FSIS had dramatically changed HACCP, and the agency still concludes, as did Mr. Billy, that there’s nothing we can do about it. But let’s talk more about testing.
    True HACCP did not require product testing because true HACCP plants already tested safety into EACH INDIVIDUAL segment of its RTE production system. Some, but very little sampling would subsequently take place, but at much decreased frequencies once the system had been previously validated as consistently safe. While ongoing microbial sampling is not necessary in true HACCP, FSIS ironically stated that microbial sampling was the very scientific heart of its style of HACCP.
    FSIS piously proclaimed that all raw meat & poultry plants had to implement HACCP, and stated that the agency had a Zero Tolerance for fecal bacteria. Mission Impossible…..at raw plants. Nevertheless, once the large slaughter plants implemented their version of a HACCP Plan, the agency truly deregulated these raw meat plants, leaving the plants to police themselves. We need to briefly touch on promises FSIS made to the industry prior to the implementation of FSIS-style HACCP.
    FSIS publicly stated that once the industry implemented HACCP, the agency would:
    1. Embrace a “Hands Off” role.
    2. FSIS would no longer police the industry, but the industry was allowed to police itself.
    3. FSIS would disband its previous command and control authority.
    4. Each plant could write its own HACCP Plan, and FSIS could not mandate what must be in each Plan.
    History has shown that FSIS has fully complied with all 4 promises, but at the largest plants only. At the same time, FSIS has been grossly noncompliant with all 4 promises at the small plants, but that is a story for another day. FSIS without doubt deregulated the largest plants (because they had a HACCP Plan in place!), while hyper-regulating small plants.
    To their credit, the largest plants have invested untold millions into the development and implementation of interventions which have truly minimized the presence of pathogens. Our ongoing outbreaks prove that these interventions have not been 100% effective. I do not blame the large slaughter plants because pathogens are still being shipped into commerce. Frankly, plants producing raw products without kill steps simply cannot produce consistently safe meat, in spite of FSIS-style HACCP already in place.
    Let me give you an example of the value of interventions, and FSIS’ willingness to truly deregulate the large abattoirs once the interventions are in place.
    I am holding a ConAgra publication entitled “The Strongest Chain of Safety”, one part of which discusses “Verification of Interventions”. It refers to studies conducted by NCBA and Colorado State University, which concluded “Most importantly, 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” (emphasis mine). A subsequent Meatingplace.com article on May 10, 2002, reported on ConAgra’s implementation of one additional intervention which “providing bacteria reduction of 99.99999 percent”, which is a 7-log reduction. Wow!
    Two months later, on July 19, 2002, ConAgra announced a 19 million lb recall of beef that may be contaminated with E.coli O157:H7. So much for 7 logs.
    One year later, OIG released the findings from its investigation of the ConAgra recall. Two verbatim quotes from the OIG report are as follows:
    “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 mine) problem at ConAgra”
    “Although animal feces on product was REPEATEDLY OBSERVED (emphasis mine) during production at ConAgra, USDA took no enforcement action”.
    Mike, how could FSIS take any enforcement then….or NOW? The agency had already promised to be limited to a “Hands Off” non-involvement role, no longer police the industry, and had willingly jettisoned its previous command and control authority.
    Let’s get back to microbial testing, to which you referred in your comments yesterday. Remember that FSIS publicly acknowledged that microbial testing was the very heart of its version of HACCP. Well, the largest plants implemented HACCP on January 26, 1998. On February 1, 1998 (a mere six days later), FSIS issued Directive 10,010.1 which exempted qualified plants (including the largest plants) from agency-conducted microbial sampling. So, ConAgra and the other large packers were allowed to do their own testing, while FSIS was forced to avoid testing. You already know how this scenario played itself out at the ConAgra plant. After ConAgra’s recall, an article in the Greeley CO Tribune stated “They [FSIS investigators] found contaminated meat had been processed at the [ConAgra] plant on at least 34 days going back to April 12, said Dan Puzo of the inspection service”. 34 positives in 100 days doesn’t qualify for Zero Tolerance, but FSIS could care less, as they enjoyed the comfort of deregulation, effectively insulating themselves from adverse lab results. Subsequent articles revealed that the agency had been denied access to lab results of ConAgra’s in-plant sampling. FSIS could care less.
    Mike, the point being here that totally opposite of true Pillsbury HACCP, FSIS-style HACCP placed and continues to place pre-eminent importance on microbial sampling. Why? Because FSIS-style HACCP is not true HACCP, and is not science-based. Plants producing raw meat & poultry absolutely cannot produce consistently safe food. True HACCP truly embraces and provides zero tolerance, but FSIS-style HACCP’s claim to Zero Tolerance is based on pseudo-science, science fiction, and political science. FSIS word masters have portrayed its version of HACCP to be the ultimate, science-based protector of public health, but our ongoing outbreaks and recurring recalls prove otherwise.
    One last thing about testing: 2 years ago, FSIS inspectors commenced issuing NR’s (noncompliance records) against plants which allegedly did not utilize appropriate lab test protocol, allegedly inferior scientific protocol. Plants responded that they would require labs to improve their scientific protocol, and asked what minimum protocol FSIS required. FSIS replied then, and today, that the agency does not prescribe minimally acceptable protocol, and that each plant can develop their own protocol, but it must be based on peer-reviewed, acceptable lab protocol. Plants responded “Okay, we’ll do whatever is required, but what is it?” FSIS officials responded “We can’t tell you what to do, you decide that”. Well, after this travesty was revealed, I’ve heard of no recurrences of such intentional agency misbehavior since. But the implications of such FSIS tactics spell problems when we commence testing for the Big Six non-O157:H7 STEC’s this March, to which you refer. What is the agency’s minimally-acceptable protocol for testing for these six new bugs? Who knows? Who cares?
    And, if FSIS-style HACCP is indeed true HACCP, based in science, why should we be testing trim and ground beef after all? Answer: because FSIS-style HACCP is NOT true HACCP! Raw meat products do not qualify for true HACCP. Unwilling to admit this increasingly obvious conundrum, FSIS officials scurry about, concocting new mandates against the industry including unknown test protocol for the Big 6 STEC’s. If testing is required, especially a continually increasing incidence of testing, well, quite frankly, FSIS-style HACCP is NOT HACCP! You ask who is going to pay for replicate testing on all those samples? Yup, plants. Why? If indeed our raw meat complies with Zero Tolerance, why are we testing it?
    FSIS conceived its version of HACCP in deceit, spawing inevitable public health outbreaks.
    Raw is raw, and RTE is RTE. True HACCP doesn’t cover both.
    Production of raw meat can benefit from implementation of HACCP principles, but still does not qualify for the HACCP umbrella, and certainly does not qualify for gov deregulation. FSIS disagrees, as the agency is looking for justification for its ultimate desire, which is to semi-retire at the industry’s largest and most powerful establishments, a potential legal Goliath to avoid at all costs. Hands Off!
    John Munsell

  • Mike, your points and questions are erudite! Since I read your comments last night, sleep has evaded me, because your questions MUST be answered. Not possible with a few brief all-encompassing conclusions for which no justification is provided. This will be lengthy, but I contend, required.
    You hit the nail on the head when focusing on the agency’s perceived need for additional microbial sampling, realizing that HACCP was trumpeted by FSIS as our salvation. Mike, you won’t like the truth.
    In the mid-90’s, when FSIS was designing its style of HACCP, then-Administrator Tom Billy told a member of the agency’s NACMCF “We are changing HACCP, and there’s nothing you can do about it”. Mike, changing it from What?
    Pillsbury invented HACCP, commencing in 1959, in partnership with NASA and the Dept of Army, both of whom needed consistently safe, ready-to-eat food. Imagine an astronaut vomiting and suffering diarrhea in the weightlessness of outer space. Pillsbury’s initial, and true, HACCP protocol was designed for plants making fully-cooked, ready-to-eat food which was consistently safe. Pillsbury-style HACCP required HACCP plants to test safety into every single component of its food production line. For example: let’s say a food system had ten segments. Plants would have to initially perform a multitude of microbial tests at each of the 10 segments, to ensure that EACH SEGMENT could individually prove that it was safe, and did not introduce contamination into the product or allow pre-existing contamination to remain. Pillsbury called this “Process Control”, where each process, or step, had to stand by itself and prove that it was safe. Once the entire process continually proved that each process, and the entire process, produced safe food, only at that time could the plant qualify for HACCP consideration. Once validated, we can see that the plant truly qualified for deregulation: no need for intensive gov scrutiny of such RTE plants. Many contemporary meat plants, or portions thereof, truly qualify for HACCP today, including products such as jerky, beef sticks, pre-cooked turkey breasts and roast beef for deli sandwiches, etc. These plants truly police themselves, and proudly sell such products as safe, and ready to eat. Pillsbury always intended HACCP to be a voluntary program, exclusively designed for only those plants willing to invest in production protocol which can be proven to consistently produce safe food.
    So, how did FSIS and Tom Billy “CHANGE” HACCP? First of all, FSIS mandated that every USDA-inspected (and state-inspected) plant implement HACCP. Therefore, all plants producing RAW meat & poultry likewise had to implement HACCP, even though we all know that raw meat & poultry carries risk…..unlike RTE products. FSIS further complicated things by proudly proclaiming its “Zero Tolerance” for fecal, injesta & milk. Good luck! Raw meat, absent a kill step, will never be free from enteric bacteria. FSIS knew better, but its Zero Tolerance declaration had a good sound byte.
    After the JITB outbreak in 1993, FSIS announced that the industry and the agency must change to the HACCP protocol. In the mid-late 90’s, a multitude of official HACCP Training Sessions were held across the country, educating and training meat plant officials of this new protocol. The sessions were conducted by academicians familiar with HACCP, FSIS representatives, and industry officials. I attended two of these intensive sessions, in Salt Lake City and Kansas City. The trainers all stated that HACCP constituted a big imporovement over the agency’s previous meat inspection system, primarily because HACCP would be “Science Based”. In the two sessions I attended, the audience demanded an explanation of what “Science Based” meant. Two answers were provided:
    1. Under HACCP, each plant would police itself, and FSIS would no longer police us.
    2. Under HACCP, plants and the agency both would collect microbial samples for lab analysis to detect the presence of pathogens, detection which was not possible under the agency’s previous organoleptic system. When I implemented HACCP in 2000, my family-owned plant had never collected one microbial sample in its previous 54 years of existence. During those 54 years, FSIS had collected few, IF ANY, such samples either. Fortunately, 4 agency samples of ground beef at my plant all revealed the presence of E.coli O157:H7 in January & February 2002. Agency reaction to those 4 positives is a story all its own. Suffice it to say that microbial sampling was the heart of FSIS-style HACCP. Well, was this the change to which Tom Billy referred?
    One man who was instrumental in developing and refining Pillsbury’s true HACCP system was microbiologist Dr. William Sperber, who worked at Pillsbury from 1972 – 1995. Interestingly, Dr. Sperber has written several articles in recent years, defining the substantial differences between true HACCP & FSIS-style HACCP. Consider this remark from an article entitled “Happy 50th Birthday to HACCP”, published in the Dec 2009/Jan 2010 edition of Food Safety Magazine:
    “It is comforting to note that the HACCP pioneers, beginning 50 years ago, established features of HACCP that have not changed. These are the following:”
    The last of the 3 items was this: “It does not rely on product testing or lot acceptance criteria”.
    Mike, this statement is heinous heresy to FSIS, which places a higher emphas on product testing every year. Indeed, as Tom Billy said, FSIS had dramatically changed HACCP, and the agency still concludes, as did Mr. Billy, that there’s nothing we can do about it. But let’s talk more about testing.
    True HACCP did not require product testing because true HACCP plants already tested safety into EACH INDIVIDUAL segment of its RTE production system. Some, but very little sampling would subsequently take place, but at much decreased frequencies once the system had been previously validated as consistently safe. While ongoing microbial sampling is not necessary in true HACCP, FSIS ironically stated that microbial sampling was the very scientific heart of its style of HACCP.
    FSIS piously proclaimed that all raw meat & poultry plants had to implement HACCP, and stated that the agency had a Zero Tolerance for fecal bacteria. Mission Impossible…..at raw plants. Nevertheless, once the large slaughter plants implemented their version of a HACCP Plan, the agency truly deregulated these raw meat plants, leaving the plants to police themselves. We need to briefly touch on promises FSIS made to the industry prior to the implementation of FSIS-style HACCP.
    FSIS publicly stated that once the industry implemented HACCP, the agency would:
    1. Embrace a “Hands Off” role.
    2. FSIS would no longer police the industry, but the industry was allowed to police itself.
    3. FSIS would disband its previous command and control authority.
    4. Each plant could write its own HACCP Plan, and FSIS could not mandate what must be in each Plan.
    History has shown that FSIS has fully complied with all 4 promises, but at the largest plants only. At the same time, FSIS has been grossly noncompliant with all 4 promises at the small plants, but that is a story for another day. FSIS without doubt deregulated the largest plants (because they had a HACCP Plan in place!), while hyper-regulating small plants.
    To their credit, the largest plants have invested untold millions into the development and implementation of interventions which have truly minimized the presence of pathogens. Our ongoing outbreaks prove that these interventions have not been 100% effective. I do not blame the large slaughter plants because pathogens are still being shipped into commerce. Frankly, plants producing raw products without kill steps simply cannot produce consistently safe meat, in spite of FSIS-style HACCP already in place.
    Let me give you an example of the value of interventions, and FSIS’ willingness to truly deregulate the large abattoirs once the interventions are in place.
    I am holding a ConAgra publication entitled “The Strongest Chain of Safety”, one part of which discusses “Verification of Interventions”. It refers to studies conducted by NCBA and Colorado State University, which concluded “Most importantly, 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” (emphasis mine). A subsequent Meatingplace.com article on May 10, 2002, reported on ConAgra’s implementation of one additional intervention which “providing bacteria reduction of 99.99999 percent”, which is a 7-log reduction. Wow!
    Two months later, on July 19, 2002, ConAgra announced a 19 million lb recall of beef that may be contaminated with E.coli O157:H7. So much for 7 logs.
    One year later, OIG released the findings from its investigation of the ConAgra recall. Two verbatim quotes from the OIG report are as follows:
    “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 mine) problem at ConAgra”
    “Although animal feces on product was REPEATEDLY OBSERVED (emphasis mine) during production at ConAgra, USDA took no enforcement action”.
    Mike, how could FSIS take any enforcement then….or NOW? The agency had already promised to be limited to a “Hands Off” non-involvement role, no longer police the industry, and had willingly jettisoned its previous command and control authority.
    Let’s get back to microbial testing, to which you referred in your comments yesterday. Remember that FSIS publicly acknowledged that microbial testing was the very heart of its version of HACCP. Well, the largest plants implemented HACCP on January 26, 1998. On February 1, 1998 (a mere six days later), FSIS issued Directive 10,010.1 which exempted qualified plants (including the largest plants) from agency-conducted microbial sampling. So, ConAgra and the other large packers were allowed to do their own testing, while FSIS was forced to avoid testing. You already know how this scenario played itself out at the ConAgra plant. After ConAgra’s recall, an article in the Greeley CO Tribune stated “They [FSIS investigators] found contaminated meat had been processed at the [ConAgra] plant on at least 34 days going back to April 12, said Dan Puzo of the inspection service”. 34 positives in 100 days doesn’t qualify for Zero Tolerance, but FSIS could care less, as they enjoyed the comfort of deregulation, effectively insulating themselves from adverse lab results. Subsequent articles revealed that the agency had been denied access to lab results of ConAgra’s in-plant sampling. FSIS could care less.
    Mike, the point being here that totally opposite of true Pillsbury HACCP, FSIS-style HACCP placed and continues to place pre-eminent importance on microbial sampling. Why? Because FSIS-style HACCP is not true HACCP, and is not science-based. Plants producing raw meat & poultry absolutely cannot produce consistently safe food. True HACCP truly embraces and provides zero tolerance, but FSIS-style HACCP’s claim to Zero Tolerance is based on pseudo-science, science fiction, and political science. FSIS word masters have portrayed its version of HACCP to be the ultimate, science-based protector of public health, but our ongoing outbreaks and recurring recalls prove otherwise.
    One last thing about testing: 2 years ago, FSIS inspectors commenced issuing NR’s (noncompliance records) against plants which allegedly did not utilize appropriate lab test protocol, allegedly inferior scientific protocol. Plants responded that they would require labs to improve their scientific protocol, and asked what minimum protocol FSIS required. FSIS replied then, and today, that the agency does not prescribe minimally acceptable protocol, and that each plant can develop their own protocol, but it must be based on peer-reviewed, acceptable lab protocol. Plants responded “Okay, we’ll do whatever is required, but what is it?” FSIS officials responded “We can’t tell you what to do, you decide that”. Well, after this travesty was revealed, I’ve heard of no recurrences of such intentional agency misbehavior since. But the implications of such FSIS tactics spell problems when we commence testing for the Big Six non-O157:H7 STEC’s this March, to which you refer. What is the agency’s minimally-acceptable protocol for testing for these six new bugs? Who knows? Who cares?
    And, if FSIS-style HACCP is indeed true HACCP, based in science, why should we be testing trim and ground beef after all? Answer: because FSIS-style HACCP is NOT true HACCP! Raw meat products do not qualify for true HACCP. Unwilling to admit this increasingly obvious conundrum, FSIS officials scurry about, concocting new mandates against the industry including unknown test protocol for the Big 6 STEC’s. If testing is required, especially a continually increasing incidence of testing, well, quite frankly, FSIS-style HACCP is NOT HACCP! You ask who is going to pay for replicate testing on all those samples? Yup, plants. Why? If indeed our raw meat complies with Zero Tolerance, why are we testing it?
    FSIS conceived its version of HACCP in deceit, spawing inevitable public health outbreaks.
    Raw is raw, and RTE is RTE. True HACCP doesn’t cover both.
    Production of raw meat can benefit from implementation of HACCP principles, but still does not qualify for the HACCP umbrella, and certainly does not qualify for gov deregulation. FSIS disagrees, as the agency is looking for justification for its ultimate desire, which is to semi-retire at the industry’s largest and most powerful establishments, a potential legal Goliath to avoid at all costs. Hands Off!
    John Munsell