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.

——————————

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.

  • 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?