RESPONSES TO FSIS DOCKET # 2011-0009, ENTITLED “CHANGES TO FSIS TRACEBACK, RECALL PROCEDURES FOR ESCHERICHIA COLI O157:H7 POSITIVE RAW BEEF PRODUCT, AND AVAILABILITY OF COMPLIANCE GUIDELINES”. DOCKET RELEASED ON MAY 2, 2012
FSIS is to be commended for publicly acknowledging the need for tracebacks to the SOURCE of contamination, the obvious advantages of implementing corrective actions at the SOURCE, and the need for agency enforcement actions when a SOURCE slaughter plant experiences High Event Periods (HEP). These common sense imperatives should have existed long before HACCP’s advent. Since HACCP has now been in operation for over 14 years, and is allegedly based in “science”, FSIS is fully justified in implementing science-based responses to adverse lab findings at slaughter plants. Public Health considerations mandate implementation of these traceback activities; thus, enactment of agency traceback policy improvements should not require public or industry “approval” or endorsement.
The embarrassing ongoing outbreaks and recurring recalls this century, now over 14 years after HACCP’s implementation, reveal that pathogens are a constant and formidable adversary, and that a mid-course FSIS reassessment of its HACCP ideal requires corrective actions to prevent recurrences. Our inability to effectively rein in enteric bacteria proves that FSIS’ historical focus since 1998 on downstream further processing plants instead of SOURCE plants (by intentional agency design) to prevent the INTRODUCTION of enteric bacteria into beef products has been a failure. This should have been predictable.
The agency’s newest Traceback suggestions also give us an opportunity to scrutinize systemic shortcomings within FSIS-style HACCP. The agency’s current suggestions have implications which are contrary to the agency’s authority to implement, given the artificial restrictions the agency placed on itself when mandating its version of HACCP upon the meat and poultry industries. So, FSIS is benefitting public health by not only promoting tracebacks to the SOURCE, but also providing us the occasion to critically discuss how FSIS-style HACCP can coexist with heretofore prohibited tracebacks to the SOURCE.
My comments will make limited references to my personal dealings with FSIS: not to focus on my meat plant, which I sold in 2005, but to pose for public discussion what should have been the foreseeable and natural consequences of FSIS-style HACCP, coupled with inevitable consequences of these recent agency Traceback suggestions. I respectfully suggest that open and unrestricted public discussion of these consequences now will circumvent ugly and unnecessary confusion and poor FSIS morale if such discussion is delayed for a future day. “Educate before you Regulate” was the motto of the agency’s new Small Plant Outreach (via OOEET) a few years ago, and should be the driving force today as well.
President Obama and USDA Sec Tom Vilsack have publicly stated that the agency needs to be fully transparent. An unrestricted discussion of Traceback implications will stretch the agency’s willingness to comply with this transparency promise.
My comments are intentionally thorough, which will discourage anyone looking for a quick fix. Although we don’t want to live in the past, we need to look at historical FSIS policies, discuss why they failed, and avoid treading these failed paths again. Likewise, we must methodically discuss and dissect the agency’s Traceback suggestions, not only to ensure they are viable, but also to prove these Traceback suggestions primarily promote public health, not agency comfort. FSIS has attempted to fully justify its previous monolithic opposition to Tracebacks to the abattoir source of E.coli O157:H7 contamination, and its absolute refusal to Force the Source to clean up its act. FSIS’ refusal to enact common sense Traceback protocol has become globally conspicuous, forcing the agency to finally present some Traceback protocol. Suggestions from the President’s Food Safety Working Group are also forcing FSIS to pay more than lip service to Tracebacks.
Similar to a leopard’s inability to change its spots, we cannot assume FSIS sincerely desires to Force the Source to become accountable for pathogen-laced meat. Therefore, we must place these agency suggestions under a microscope, and discuss (with no artificial agency limitations) potential shortcomings in the suggestions. Some agency suggestions, such as its overly liberal number of daily E.coli presumptive positives allowed before a “High Event Period” is even considered and delaying enforcement actions for 30 days should raise red flags to anyone who eats food. These agency suggestions have ramifications well beyond Traceback protocol, requiring due diligence on our part to consider all potential ramifications.
If FSIS maintains their intentionally inadequate policies, we’ll be discussing these same issues in five years. Why wait?
So, I don’t apologize for the length of this report, as I want to avoid merely skimming the surface. Get a cup of coffee, read this, then bounce your suggestions and criticisms off me.
Truth requires time.
RESPONSES TO AGENCYTRACEBACK SUGGESTIONS
On page one, FSIS refers to “…….the sole supplier of beef trim source materials”. FSIS must expeditiously and clearly delineate if beef trim source materials include intact cuts, such as boxed beef. Further processing plants daily generate volumes of bench trim while processing intact cuts from boxed beef, and grind the bench trim into ground beef. A statement on page 9 of this report states “Using the supplier information, EIAOs will then conduct traceback investigations at establishments that produced the E.coli O157:H7 positive product and at suppliers that provided source materials for ground beef or BENCH TRIM (emphasis added) that FSIS has found positive”. The conundrum which these new agency suggestions creates is that FSIS has previously declared that E.coli O157:H7 (hereafter referred to as ECH7) when residing on the surface of intact cuts are NOT adulterants, an odd policy realizing that the agency has classified ECH7 an adulterant in trimmings and in ground beef. Further complicating this imbroglio is the agency’s “Zero Tolerance” standard for ECH7. FSIS is highly tolerant of ECH7 on intact cuts however, an improbable position statement causing cognitive dissonance to legitimate scientists. This constitutes an incredible and indefensible position for an agency which admits it is responsible to protect the public from foodborne outbreaks. If FSIS continues its previous untenable position on sacrosanct intact cuts, the suggestions in this new release are diametrically opposed to existing agency beliefs on intact cuts’ insulation from ECH7 accountability. Without specifically clarifying this issue, confusion will reign within FSIS ranks and the industry, unnecessarily so. Therefore, FSIS must quickly clarify this issue, and explain if ECH7 on intact cuts is still considered to be a feckless contaminant, allegedly posing no threat to public health.
A statement found on page 9 of FSIS Directive 10,010.1 Rev 3 classifies bench trimmings from boxed beef as Beef Manufacturing Trimmings, and thus, would be adulterated if ECH7 are detected on intact cuts. The statement says “Beef Manufacturing Trimmings are…….raw beef source materials from subprimal cuts (e.g., steaks and roasts) or primal cuts (e.g., round, loin, rib and other primals listed in 9 CFR 316.9), or boxed beef parts of boneless beef that establishments frequently use as components of raw ground beef”. FSIS is fully cognizant that establishments do indeed routinely use components from subprimals and primals to produce ground beef. It is essential in any Traceback discussion to acknowledge that bench trim is no more inherently risky than intact cuts from which bench trim emanates.
Page 4 makes reference to the President’s Food Safety Working Group (FSWG) recommending “…trace contaminants back to their source”, forcing FSIS to develop Traceback policies. I would think FSIS is red-faced, in that it resisted Traceback protocol until forced to confront it because of involvement by the President’s FSWG. In several subsequent statements in the agency’s suggestions are references to the agency’s positive response to Traceback suggestions from non-agency personnel. Public Health and consumers deserve FSIS officials with the courage to unilaterally implement science-based and common sense policies without being shamed by outside entities to implement what is right. FSIS’ recalcitrance and tardiness have exacerbated the incidence of ongoing outbreaks.
Page 4 also makes this statement “…..FSIS conducts Food Safety Assessments (FSAs) at establishments that produce product (ground beef, beef manufacturing trimmings, or other raw ground beef COMPONENTS (emphasis added) that is positive for E.coli O157:H7”. Since intact cuts produce mountains of bench trim, which is processed into ground beef, does FSIS consider intact cuts as “components” of ground beef? It should, although FSIS is greatly embarrassed to admit it. Once again, FSIS must clearly and publicly delineate if ECH7 on intact cuts are adulterants. If not, the agency must justify its endorsement of slaughter plants’ rights to ship into commerce intact cuts which are surface-contaminated with ECH7. And in containers proudly emblazoned with the official USDA Mark of Inspection which states “USDA Inspected & Passed”. At the present time, USDA inspects and passes intact cuts which are surface-contaminated with ECH7. This diabolical double standard means that ECH7 on intact product is NOT injurious to one’s health. If I were to make a movie of this, I’d call it “Dumb and Dumber”
The first sentence on Page 6 refers to “…..slaughter and dressing operations – where contamination is most likely to occur”. This refreshing agency admission runs counter to historical actions implemented by FSIS officials at dozens of small further processing (non-slaughter) plants where positive lab results have occurred. Instead of tracing back to the SOURCE of contamination, FSIS has consistently blamed the further processing plant of introducing ECH7 into their product. To prove the agency’s biased allegation, EIAO’s and other agency officials are forced to dedicate endless weeks poring over the establishment’s HACCP Plan and related Plans until adequate “evidence” can be fabricated which allegedly proves that the plant has sanitation failures, requiring a Reassessment and Corrective Actions. Simultaneously, of course, FSIS refuses to trace back to the source, even when it is a sole source supplier, and insulates the supplier from the need to implement any corrective actions. We should not be the least surprised by our spate of ongoing outbreaks and recurring recalls, because the agency’s bulls eye has been erroneously and intentionally focused downstream, as far away from the source as possible. Small plants are much easier enforcement prey.
A statement is made on page 6 that “….loss of process control….may affect the disposition of INTACT (emphasis added) (primal and subprimal) cuts of beef, in addition to beef manufacturing trimmings”. Again, it appears that FSIS is now stating the intact cuts can be a source of pathogens. But, I’m not sure, nor is anyone else with whom I visit on this issue. FSIS must publicly delineate its position on this issue.
Page 8 makes a reference to Notice 58-10, issued October 8, 2010. This Notice requires agency inspectors to document the SOURCE origin of meat being sampled, at the time of sample collection. I had ardently suggested this practice to FSIS since February, 2002, with no success. The agency required only 8 years and 8 months opposing my suggestions before removing its blinders on this common sense issue. I give the agency credit for overriding assiduous opposition from its lifer bureaucrats and attorneys, and implemented science-based sampling protocol for a welcome change.
Page 9 includes this statement “EIAO’s will then conduct traceback investigations at establishments that produced the E.coli O157:H7 positive product and at suppliers that provided source materials for ground beef OR BENCH TRIM (emphasis added) that FSIS has found positive”. Again, the fact that FSIS will perform traceback investigations at suppliers of product from which bench trim is obtained seems to indicate that perhaps FSIS now considers ECH7 residing on intact cuts to be adulterants. If FSIS sincerely acts with “An Abundance of Caution”, the agency must unequivocally delineate if ECH7 on the exterior of intact cuts is considered an adulterant. If not, FSIS must provide science-based justifications for hiding its head in the sand (or…..hiding ECH7 lethality when the pathogen merely resides on intact cuts).
A statement on page 9 says “EIAOs will visit both the establishment that produced the positive product and the supplier slaughter establishment and gather relevant information about the production of the product, including use of anti microbials and prevention of cross contamination, sanitary conditions, and relevant purchase specifications”. A mere discussion of and investigation into (a) use of anti microbials and (b) prevention of cross-contamination encompasses information already available to in-plant inspectors. If a source plant has inadequacies in (a) or (b), current in-plant inspectors would have already been (or should have been!) fully cognizant of these short comings. At least in small and very small plants, dozens of inspectors, veterinarians, FLS’s, CSO’s, EIAO’s, and District Office personnel have already copiously scrutinized every HACCP Plan detail since 1999. The issue here is NOT whether an establishment’s HACCP Plan is inadequate, which would have been detected years ago. Instead, the real issue is (a) did the source supplier slaughter plant produce ECH7-contaminated meat, and (2) identify corrective actions available to the source plant to prevent recurrences. Meaningful corrective actions to prevent recurrences can only be accomplished on the kill floor, not by adding a page to the HACCP Plan. FSIS disagrees, as it has now placed primary emphasis on paper flow. Changes in the source slaughter plant’s production protocol which are capable of improving food safety are not theoretical in nature (i.e., written HACCP Plans or various other plans), but improvements in real-life production protocol which are detected on the production line, not in FSIS review of paperwork in a cozy office setting. Organoleptic inspection (yes, I know, FSIS considers the senses of sight, smell, touch etc to be archaic……but can be highly beneficial) can reveal the truth, while paperwork can be easily falsified to ensure alleged compliance with HACCP Plans, SSOP’s, GMP’s, etc. Chapters 7 & 8 of Timothy Pachirat’s book “Every Twelve Seconds” are a self-revealing admission of how company-generated paperwork can be easily doctored. FSIS personnel with whom I visit state that many abattoirs are NOT in compliance with their variety of written HACCP policies. As such, these plants are not doing what they say, a benefit of deregulation.
Furthermore, review of purchase specifications might be interesting, but typically valueless. Why? Because in spite of source slaughter plants’ utilization of every cutting edge pathogen intervention known to mankind, the source plants do not provide guarantees of safe meat. Nor can they, when dealing with raw meat, although FSIS infers otherwise. Annual certifications from source slaughter plants include disclaimers such as “Neither we, nor for that matter, anyone is able to guarantee pathogen free raw materials”. Another says “However, there is no technology available today that can guarantee fresh meat products are free of pathogens”. These statements are absolutely true. To claim otherwise would be overt deceit. In spite of this, FSIS continues to place primary emphasis on paperwork oversight, not on inspection of meat production lines. FSIS stands for “Food Safety Inspection Service”. It should be renamed FSAS, as in “Food Safety Auditing Service”. A common complaint, well justified, is that meat “inspection” has degenerated into a paper chase, not a pathogen chase. Pathogens are detected on production lines, not in office paper flow.
Towards the bottom of page 10, the phrase of “adulterated product has entered commerce” is found in two locations, and merits close consideration. Along the same line, plants utilize “Test & Hold” protocol, preventing potentially adulterated meat from entering commerce. Subsequent to presumptive positive test results, plants regularly divert meat to plants which fully cook, preventing the meat from entering commerce, to the benefit of consumers. While diversion of potentially unsafe meat is laudable, I suggest that an equally important consideration is the need for corrective actions on the kill floor to prevent future PRODUCTION of unsafe meat. A plant with recurring presumptive positives, even though not enough to classify as a High Event Period, still has recurring sanitary dressing failures which need to be addressed and aggressively remedied. FSIS, however, disagrees. FSIS is fully satisfied with diversion of potentially unsafe meat, and is blithely unconcerned with recurring PRODUCTION sanitation failures on the kill floor, and is aloof to the need for improvements in sanitary dressing procedures. Rather than proactively challenging such kill floors to implement changes to reduce the PRODUCTION of meat causing presumptive positives, FSIS is satisfied with congratulating the establishment for diverting recurring batches of unsafe meat. As such, FSIS is foolishly focused exclusively on shipment into commerce, rather than production of unsafe meat. If FSIS instead would place primary emphasis on production practices, and the plant successfully implements improvements in production practices, shipment of unsafe meat into commerce concerns will greatly dissipate. The reverse is not true, which FSIS fails to acknowledge, let alone grasp.
Enforcement actions must not be predicated on shipment of adulterated meat into commerce, but on production of unsafe meat. If we focus on shipment, rather than prevention at the source, we are virtually guaranteed ongoing production of unsafe meat, some of which will evade detection by testing. The primary reason NASA and the Army contracted Pillsbury in 1959 to develop HACCP was because product testing failed to produce consistently safe food. In the last ten years, positive tests have occurred on only 3/10ths of 1% of all samples. Because of the low incidence of ECH7, testing is somewhat akin to searching for a needle in the haystack, ensuring that ECH7 will NOT be detected in a goodly % of samples. The efficacy of Test & Hold is minimized, realizing that N60 testing of trim (when the incidence of ECH7 is so low), is statistically irrelevant. Therefore, shipment into commerce should not be our overriding concern, but sanitary dressing production failures on the kill floor, which are not always detected via testing.
Therefore, the industry’s pious proclamation that it “Tests every lot, and diverts all potentially positive meat to a cooking plant” has a hollow ring to it.
Page 11 provides a list of 5 criteria which must be met before FSIS requests a slaughter plant to recall product. Criteria #3 states “FSIS determines that the grinding establishment did not combine material from multiple source lots to create the lot of product that tested positive”. While the act of commingling does indeed hinder (but not prevent!) a successful traceback to the SOURCE, FSIS abdicates its responsibility of protecting the public from foodborne outbreaks by summarily rejecting tracebacks emanating from commingled meats. Many folks have commented to me over the years that commingling meats is a primary cause of contaminated meat. This misconception reveals that the agency has successfully accomplished its intent to deceive consumers. Commingling (or blending) of meat does NOT introduce pathogens, but does spread them. Commingling meat is not a food safety hazard, is legal, and commonly used. If commingling were outlawed, our industry would be forced to grind 50/50 trim by itself, producing a greasy product no one would purchase. Likewise, lean bull meat would have to be ground with no mixture, producing burger which lacks enough fat to cook the product, crumbling during the cooking process. Meat with differing fat/lean characteristics must be blended to produce a marketable product. Instead, FSIS has portrayed the image that blending meat from different sources is a primary method of INTRODUCING pathogens into meat, a blatantly false inference.
When meat is tested, I highly recommend samples be taken from single source meat, not only to aid in traceback to one source, but also to deny FSIS the ability to falsely accuse the grinding plant of creating unsafe meat by blending meat from more than one source. Many consumerists are totally in the dark on this issue, not by choice, but because they’ve been mislead by agency statements.
So, FSIS traceback activities on commingled products can reveal the one noncompliant source slaughter plant, enabling recall requests. Additionally, FSIS must be fully transparent on the issue of commingling, and publicly explain what I’ve said in the paragraph above. Don’t hold your breath. FSIS’ unwillingness to aggressively investigate positives in commingled meat batches is but an intentional agency obfuscatory stratagem designed to insulate the production source from accountability.
Attempting to sample only single source product whenever possible runs contrary to pure random sampling. True! Science-based random sampling requires that ground beef be chosen for microbial sampling with no regard to its being single source or commingled. However, successful tracebacks to the source are minimized when testing commingled samples. Therefore, FSIS must decide which god it will serve:
- The god of tracebacks to the source, which will benefit public health.
- The god of pure random sampling, which will in many cases prevent a traceback to the true source of contamination, circumventing meaningful corrective actions at the source.
Currently, FSIS worships at the altar of the god of random sampling, to the detriment of public health.
Page 12 refers to 65 positive ECH7 samples FSIS detected in 2009 & 2010 from routine agency-conducted sampling called “Verification Sampling”. 29 of these 65 positives were collected at non-slaughter plants which purchased all their meat from but one source slaughter provider. In spite of knowing which one slaughter plant produced the adulterated meat, FSIS refused to perform tracebacks to the one well-defined source. An agency official publicly admitted in late 2010 that the agency did NOT perform tracebacks as a result of Verification Sampling, but only as a result of public health outbreaks. What we don’t know won’t hurt us. Therefore, FSIS intentionally circumvented 29 golden opportunities to initiate enforcement actions at the SOURCE, focusing instead on the victimized downstream entity which unwittingly purchased meat which was previously-contaminated with invisible bacteria. The agency expects such downstream plants to (a) detect and (b) remove invisible pathogens, two duties which neither the agency nor the source slaughter plant were capable of accomplishing. FSIS has no shame.
Therefore, FSIS assigned all liability against the downstream grinding plant, while insulating the SOURCE from any accountability. No corrective actions to prevent recurrences were mandated against or implemented by the source slaughter plant, thereby guaranteeing future recurrences of production of meat laced with ECH7. Instead, FSIS typically forces victimized downstream plants to implement corrective actions which allegedly could prevent their future purchase of meat adulterated with invisible pathogens. This utterly unscientific misdirection of accountability virtually guarantees future public health outbreaks. A person sickened by lung cancer does not benefit from surgical removal of a finger. Likewise, public health benefits by corrective action focused against the SOURCE. Since HACCP’s advent in 1998, FSIS has been playing loose & easy with the SOURCE of ECH7-laced meat, contributing to dozens of outbreaks, while hiding behind the skirt of “Science”, a definition of which has become ephemeral to the agency.
One statement found on page 14 states “Contamination may occur through cross contamination at the grinder”. Contamination is not introduced at the grinder! Commingling of meat, some of which harbors invisible bacteria, does indeed spread the pathogen, but does not introduce the bug, a huge distinction which FSIS adroitly avoids. This lack of clarification has caused confusion to folks outside our industry who blindly believe the agency’s scurrilous statements.
Plants which purchase intact cuts laced with ECH7 processes the cuts into steaks, roasts, burger, etc, a process which does indeed spread the pathogen throughout the processing room. A partial list of associated equipment includes knives, saws, cutting boards, conveyor belts, wrapping stations, scales, and personal gear such as aprons and gloves. All meat subsequently touching any of this equipment later in the day has a good probability of transporting the hitch hikers into your kitchen and mine.
FSIS now has a long history of accusing such downstream plants of (1) the production of contaminated meat, (2) negligently causing cross contamination, and (3) allegedly guilty of ongoing insanitary conditions. Simultaneously, FSIS artfully dodges the truly noncompliant source slaughter plant, absolving them of (1), (2), and (3) above.
Pretty nifty, eh?
Pages 15 & 16 refer to unsafe meat at plants experiencing high rates of presumptive positives. One statement was “Such insanitary conditions may affect the safety of INTACT (emphasis added) (primal and subprimal) cuts, trim, and other beef components used in the production of ground beef”. Why is the agency suddenly concerned with the microbiological safety of intact cuts? FSIS has historically declared that ECH7 residing on the surface of intact cuts are NOT adulterants, but mere contaminants. Agency logic therefore concludes that when these intact cuts are further processed at downstream further processing plants, retail meat markets, and at hotels, restaurants and hospital/nursing home cafeterias, these heretofore harmless contaminants supernaturally transform themselves into lethal adulterants. This beguiling FSIS nomenclature deception has intentionally granted a free pass to the source slaughter plants, a procedure which FSIS subtly characterizes as “An Abundance of Caution”. This agency “caution” protects the slaughter plants, but imperils public health.
Pages 17 & thereafter discuss particulars of High Event Periods (HEP’s). These agency declarations run contrary to FSIS pre-HACCP promises to the industry, which must be discussed. In the mid-90’s, when the agency introduced & mandated HACCP to the industry, FSIS dangled carrots in front of the industry in order to obtain our “voluntary” embrace of the new HACCP system. Four of the most prominent carrots used to entice us included the following:
- Under HACCP, FSIS would embrace a “Hands Off” role in the meat industry.
- Under HACCP, “FSIS would no longer police the industry, but the industry must police itself”.
- Under HACCP, “FSIS would relinquish its previous command-and-control authority”.
- Under HACCP, “plants could write their own HACCP Plans, and the agency could not tell plants what must be in their HACCP Plans”.
As a side note, FSIS has been grossly noncompliant with all four promises at small plants, but much more compliant at large plants. Again, small plants are much easier enforcement prey. FSIS-style HACCP has deregulated the large plants (as promised), while hyper-regulating small plants.
FSIS’ current intention to implement traceback protocol, to define what constitutes High Event Periods, and justify agency enforcement actions are in stark opposition to the four promises listed above. When FSIS mandated HACCP, coupled with these four promises, it hoped against hope that a deregulated industry would step up to the plate and unilaterally devise interventions capable of preventing additional outbreaks such as experienced during the Jack-In-The-Box outbreak. The industry has invested millions designing multiple-hurdle pathogen intervention systems which have unquestionably made our food safer. Although FSIS-style HACCP has now had over 14 years to iron out the wrinkles, and the incidence of some pathogens has diminished, outbreaks and recalls persist. A chagrined FSIS is now attempting to illegally reclaim some of its voluntarily-jettisoned authority. Even though the industry has lived up to its part in this HACCP bargain, FSIS desires to reassert its policing and command-and-control authority, as well as mandating changes in our HACCP Plans. When meat plants resort to Bait & Switch tactics, FSIS has us in court. When FSIS uses Bait & Switch, it should lose all court challenges from the industry, for good reason. The FSIS HACCP Hoax will be discussed more thoroughly in my conclusions. For now, suffice it to say that FSIS-style HACCP requires substantial mid-course corrective actions………on the part of FSIS, which is now non-compliant with its pre-HACCP promises.
Page 17 includes this statement “Based on these results, FSIS selected a target of 5% (test positives) for the HEP criteria”. Interestingly, data on pages 19 & 20 reveal that FSIS will allow (depending on plant size & number of samples taken daily by the plant) between 8% & 29% before the agency concludes a HEP might have occurred. FSIS must more clearly explain these apparent discrepancies.
At an industry conference in Chicago in September, 2008, the agency’s Dr. Daniel Engeljohn provided a PowerPoint presentation entitled “Testing: FSIS Perspective”. One slide was entitled “FSIS Framework for Event Days”. One sentence in the slide stated “2 in 24 or 4 in 91 N60 samples could represent a cluster of positives potentially evidencing insanitary conditions”. This means that “only” 3 in 91 (3.3% positives) would NOT indicate insanitary conditions. While I thought the agency was being overly generous and liberal by allowing 3.3% positives for ECH7, others in the industry objected to the agency’s apparently overly-restrictive limitations. At a subsequent public hearing on Tracebacks in March, 2010 in Washington, DC, an AMI official read a prepared statement which included the following: “AMI remains committed that the predetermined number of positive test results to describe a high event period for an establishment, as previously mentioned by FSIS, has no basis”. Reference to this AMI statement is made in the middle of page 28 of the agency’s new Traceback suggestions. FSIS paid heed to this AMI caution, resulting in the 5% – 8% – 29% allowable maximums in the agency’s recent release.
Therefore, a slaughter plant with 4% or more positives is well within the agency’s acceptable range, and no corrective actions are mandated or implemented. All potentially positive product is diverted, and FSIS congratulates the slaughter plant because its “HACCP Plan is working”. But when a small downstream (non-slaughter) plant experiences but one positive, the agency accuses it of experiencing a HACCP Failure, and requires a Reassessment and Corrective Actions. Industry folks have told me of a slaughter plant which had dozens of positive samples in a single day, and nearly 100 in a month, but FSIS took no action, because the plant’s HACCP Plan was working because no unsafe meat was shipped into commerce! The agency’s biased illogic is incredulous and breath-taking for its insulation of the industry’s largest slaughter establishments.
Allowing an establishment to experience up to 5% or more positives in a shift or a day, before classifying the positives as a High Event Period, reveals the hypocrisy of the agency’s Zero Tolerance Mandate. In a sinister turn of events, Zero Tolerance does NOT apply at the large source slaughter plants which are not required to implement corrective actions. Yet, hell hath no fury like FSIS when it detects but one positive at a downstream further processing plant, automatically accusing the plant of having a HACCP Failure. Even when the small plant doesn’t ship the bad meat into commerce, but only experiences a positive while utilizing Test & Hold protocol, FSIS still accuses the plant of having a HACCP Failure. This agency-sanctioned double standard not only insulates source slaughter plants from accountability, but exposes the agency’s bias against small plants…….which the agency desires to flush out of the federal system. FSIS doesn’t necessarily want to shutter small plants. Rather, FSIS desires to be relieved of the responsibility of providing inspection at small plants. Think of the beneficial reduction in the FSIS budget resulting from a greatly reduced number of inspectors!
Page 17 also describes two kinds of HEPs. One of which is “A HEP that indicates a localized out-of-control event in which some specific occurrence or event caused a clustering of E.coli O157:H7 (or STEC organisms or virulence markers) that indicate contamination in product”. Reference to “some specific occurrence or event” is an attempt to minimize or white-wash the seriousness of the kill floor failure. Successful utilization of this description portrays the image that ongoing positives are but isolated, non-recurring problem. Examples of specific occurrences or events would include one-time events like an equipment failure or a new employee who didn’t understand sanitary carcass dressing protocol. Such infrequent problems are easily and permanently rectified. However, ongoing positives (such as 5% or 8%) reveal that recurring sloppy dressing procedures exist, easily exacerbated by high speed chain operations. Recurring arrivals of animals carrying high loads of tag (fecal-laced manure) guarantees increased difficulty keeping carcasses free of bacteria, and do not constitute remote or isolated events, but ongoing, systemic problems which FSIS finds too delicate to handle for political and legal reasons.
This “specific occurrence or event” terminology provides an opportunity for the abattoir to fabricate isolated, supposedly non-recurring events to be the alleged hapless scapegoats, even dozens of times daily. This allows the abattoir to adroitly avoid the more difficult task of implementing meaningful corrective actions to prevent future recurrences when ongoing systemic insanitary dressing failures regularly occur.
The agency’s description of the first kind of HEP includes the statement “Generally, intact primal and subprimal cuts would not be affected if such cuts routinely undergo a pathogen reduction treatment”. Again, FSIS exempts intact cuts from agency surveillance, blithely claiming that intact cuts do NOT constitute a food safety hazard because they routinely undergo a pathogen reduction treatment. Thus, FSIS chooses to ignore the fact that bench trim (which the agency considers “High Risk”) emanates from these same intact cuts which the agency claims “would not be affected” by a HEP. FSIS considers intact cuts to be a political hot potato, so chooses to issue a Pathogen Free Pass to intact cuts. The agency also fails to acknowledge that the highly-heralded microbial treatments of intact cuts are not always successful, as is proven by ongoing detection of pathogens in bench trim. If antimicrobial intervention treatments used on intact cuts were successful, bench trim would not be risky, a fact FSIS coyly sidesteps.
Another statement on the bottom of page 18 is “….a systemic HEP may indicate a broader problem (such as systemic failure to prevent cross contamination among carcasses)”. Rather than using the subterfuge of “cross contamination among carcasses”, the agency should simply state “fecal contamination of carcasses”. While carcasses can indeed be cross-contaminated by rubbing up against other carcasses which carry pathogens, the primary source of carcass contamination is the unwitting deposit of fecal bacteria caused by sloppy kill floor dressing procedures, an always present danger, exacerbated at high-speed plants. FSIS disingenuously creates the impression that ECH7 is introduced via carcasses touching each other in the cooler, sidestepping the truth which is the pathogen is introduced on the kill floor. At my plant and others, FSIS enforcement officials used this issue of carcasses touching each other in the cooler as a diversionary tactic, delicately evading the necessary function of detecting the true SOURCE of contamination on the kill floor.
If FSIS is sincerely concerned about cross contamination caused by carcass-to-carcass contact, the agency would display equal concern with cross contamination caused by deposition of bacteria onto conveyor belts, saws, knives, employee clothing, etc. Once invisible ECH7 bacteria are deposited onto all such equipment, it cross-contaminates meat subsequently coming into contact with the equipment. N60 lab positives of trim should at the very least implicate trim in the lots just before and immediately after the positive lot. While FSIS pays lip service to cross contamination, its policies conveniently ignore obvious and substantial cross contamination threats. Intact cuts which are surface-contaminated with ECH7 are unquestionably risky, must be recalled, and ECH7 on intact cuts must be classified as adulterants. Classifying ECH7 which is on the exterior of intact cuts as but a mere contaminant is a superlative example of lack of agency concern for cross contamination. If FSIS is sincerely concerned with cross contamination, the agency must classify ECH7 as an adulterant wherever it is found past the kill floor. FSIS nonchalantly disagrees.
Page 19 provides criteria FSIS will use to identify HEPs at lower volume establishments. One statement is “For a local HEP: 3 or more E.coli O157:H7 (or STEC organisms or virulence markers) positive results out of 10 consecutive samples from production lots containing same-source materials”. This means that only 2 positives out of ten (a 20% positive incidence of ECH7) would not be a HEP, and would require no corrective actions. Allowing a 20% incidence of unsafe meat, decoupled from any corrective actions makes a public mockery of Zero Tolerance, and imperils consumers, with full FSIS endorsement.
The following statement is found on the bottom of page 22, extending to the top of page 23: “FSIS intends to instruct EIAOs that when a HEP has occurred based on the establishment’s criteria or FSIS criteria, they are to determine whether the establishment considered whether negative tested lots of trimmings are releasable, and whether primal and sub-primal (emphasis added) product produced from the same source materials as the trimmings may be positive for E.coli O157:H7, particularly if the establishment does not have controls in place to ensure that the its primal and sub-primal product is not used for non-intact purposes (emphasis added)”. First of all, the agency again refers to potential food safety hazards associated with intact products (primals and sub-primals). Frankly, FSIS needs to publicly state, in no uncertain terms, whether ECH7 on intact products are adulterants or not. Secondly, the reference to having controls in place to ensure that primal and sub-primal product is not used for non-intact purposes (i.e., ground beef) shows the devious methods FSIS utilizes to shift all pathogen liability to downstream grinding plants, while insulating source slaughter plants from pathogen accountability.
Let me explain this in layman terms. The agency is stating here that source slaughter plants should have in place protocol which ensures that their customers who purchase intact cuts do not use bench trim from those intact cuts to create ground beef. Well, the vast majority of downstream customers DO use bench trim for ground beef. Take one example from my miniscule plant, which was classified as a very small plant. We made beef strips, just like chicken strips, from beef Inside Rounds. At the end of a production day, my dinky little plant accumulated an average of 700 pounds of round steak trim which produced beautiful ground beef: 85% lean, and a superb texture. Our customers, and employees, always preferred such ground beef which was actually ground round. FSIS classifies this bench trim as “High Risk”, suggesting it should be tanked or diverted to a plant which fully cooks. Such diversion greatly reduces the economic value available because of its alleged “High Risk” status.
Frankly, plants require the income derived from producing ground beef from bench trimmings to stay in business. If my dinky little plant produces 700 lbs of bench trim daily from one item, think of the tonnages produced at larger plants! If FSIS’ suggestion that such trimmings are high risk and should go to the landfill, my plant would have reduced its revenue around $ 1750 (700 pounds @ $ 2.50) per production day. Not only would this have sent me into bankruptcy, but the rest of the world would justifiably criticize America for destroying perfectly good meat. FSIS disagrees. But the agency is somewhat correct: as long as FSIS allows source slaughter plants to knowingly ship into commerce intact cuts which are surface contaminated with ECH7, not only is the resulting bench trim unsafe, but all steaks, roasts and stew produced from processing those intact cuts is likewise high risk. We should not be the least surprised at our ongoing outbreaks and recurring recalls, realizing that FSIS endorses the right of slaughter plants to ship ECH7 on intact cuts into commerce.
Secondly, how do slaughter plants ensure that their customers do not produce ground beef emanating from bench trim created by further processing the intact cuts? Frankly, the source slaughter plants cannot control how their customers utilize bench trim. But since FSIS foolishly suggests that source slaughter plants somehow control the disposition of bench trim at distant further processing plants, some source slaughter plants have resorted to printing the following statement on their invoices and bills of lading for intact boxed beef sales: “Not Intended for Grinding”. This is but yet another foreseeable consequence of FSIS endorsing the right of source slaughter plants to ship into commerce intact cuts surface-contaminated with ECH7, in containers bearing the official USDA Mark of Inspection, which is now valueless. This crafty agency stratagem to transfer pathogen liability downstream is not only breathtaking in its illogic, but threatens public health. FSIS disagrees, hiding behind the skirt of pseudo science. (Actually science fiction, and political science).
Another statement on page 23 is “If a HEP has occurred, FSIS intends to instruct the EIAO to evaluate whether the establishment verified that all controls in place in the slaughter process that are necessary to prevent E.coli O157:H7 are working as intended”. I’ll attempt to elucidate the vexatious ingenuity perpetrated by FSIS in this statement. This means that if a plant experiences “only” 8 positives (10.8%) out of 74 tests (which FSIS does NOT constitute a HEP: see chart on page 20), that the slaughter controls in place to prevent ECH7 are working as intended. So, if a slaughter plant designs its pathogen intervention system to maintain the incidence of pathogen positives below a pre-determined plateau (8%, for example), the plant will:
- Prevent High Event Periods (HEP) determinations by FSIS.
- Circumvent FSIS Enforcement Actions
- Avoid the implementation of corrective actions (after all, controls are working as intended)
- Continue to produce meat laced with ECH7, as long as its incidence remains below 8%.
Meat harboring an incidence of “only” 8% ECH7 apparently won’t sicken consumers, while meat harboring over 8%, in stark contrast, WILL sicken consumers.
Page 24 discusses how EIAO’s and District Offices will make recommendations, based on HEP data, whether enforcement actions are justified, and if the Recall Management Staff should get involved. Even when the EIAO and District Office management have irrefutable evidence proving ongoing kill floor sanitation failures, they will face daunting pressure from large abattoirs to not initiate enforcement actions, claiming that the HEP is but an isolated, local and non-recurring event. These agency folks will be reminded by FSIS officials in DC and in the District Offices to “Let HACCP Work”, a ubiquitous agency response. As in the past, the EIAO and D.O. personnel will be admonished to “not be a Maverick, but a team player”. They will also be reminded to “not lose sight of the big picture”. In other words, don’t anger the largest plants, which have enormous political clout, deep pockets, and exert abnormal influence against both USDA and FSIS. So, agency employees whose primary goal is public health can find their agency career and/or promotion opportunities terminated if they suggest or carry out meaningful enforcement actions against non-compliant large plants.
One statement on page 24 is “FSIS expects to complete the investigation and take all necessary enforcement actions within one month”. Delaying one month before initiating enforcement actions is not only a slap in the face of public health, but runs contrary to the initial (and truly science-based) Pillsbury HACCP ideals. True HACCP requires immediate corrective actions in real time when pathogens are found in products, frequently requiring a production line to be shut down until the source of the problem has been identified and resolved. FSIS’ recalcitrance to commence timely and meaningful enforcement actions against well-heeled large slaughter plants is an intentional and bold bastardization of true HACCP ideals. Regardless of FSIS-style HACCP’s overt disconnect from true HACCP, the agency should still demand timely enforcement actions when possessing HEP evidence of food safety failures, even if the non-compliant plant is a transnational behemoth. How many additional consumers will be sickened when FSIS slovenly sits on its hands for one month, after it is fully cognizant of ongoing, recurring sanitation failures at an abattoir?
An excellent example of the agency’s reluctance to implement enforcement actions at large plants, and perhaps even lacking the authority to do so, is seen in a Food Chemical News article dated February 20, 2003. The article discussed an out-of-court settlement between FSIS and Nebraska Beef. When FSIS threatened to remove inspectors from Nebraska Beef, the company counter sued, resulting in the settlement. The article said “Steven Cohen, spokesman for FSIS, told Food Chemical News earlier this month that the main reason the agency settled with the company was to eliminate the possibility that the plant could continue to operate under allegedly unsanitary conditions during months of litigation”. This embarrassing agency remark admits that FSIS lacks the authority to remove inspection, even when ongoing sanitation problems are observed. The article also stated that several entities “….question whether the real reason that FSIS didn’t proceed with litigation was that it believed that [FSIS-style] HACCP was going to be found to be illegal”. It also stated “If the Nebraska Beef settlement resulted from FSIS administrators’ lack of confidence in the agency’s authority, we fear that all inspectors around the nation will soon be getting the same message: The company’s bottom line is more important than public health. Congress needs to revamp meat and poultry laws so that the regulators, and not the regulated, control the process”.
Nine years have now passed since the above article appeared in Food Chemical News. FSIS is still in the back seat, politely asking the industry for approval (and for everyone’s comments) before the agency can initiate enforcement actions based on how many pathogen failures a plant can experience in one day. Ironically, the issue is no longer about the agency’s mandate of zero tolerance for ECH7, but what incidence of ECH7 FSIS must allow the industry to experience before the agency is authorized to even consider implementation of enforcement actions.
Frankly, the agency’s current attempt to build consensus for HEP criteria for FSIS-named “adulterants” constitutes an agency admission that it is fully cognizant that
- Zero Tolerance for ECH7 has always been non attainable, an agency PR pipe dream.
- As a replacement, FSIS is now attempting to establish an “upper level” of zero tolerance. Certainly not zero, but perhaps 8%, 15%, etc.
- The prevalence of ECH7 is much higher than FSIS had hoped, and remains a formidable bug which evades the interventions enacted to eliminate it.
- The high incidence of ECH7 makes a mockery of the FSIS “adulterant” classification. At best, all the industry can do is control, not eliminate the pathogen.
- FSIS-style HACCP is a greatly perverted version of true HACCP, which mandates (and can deliver) zero tolerance.
- Raw meat and poultry plants cannot attain zero tolerance, as they lack a kill step, a foundational requirement in true HACCP. Plants producing raw meat lack a true CCP in the absence of a kill step.
- FSIS-style HACCP deserves substantial and long overdue mid-course revisions. FSIS demands that plants annually reassess their HACCP Plans. The agency must be held to the same standard.
Since FSIS won’t eliminate its bastardized version of HACCP at raw meat and poultry plants, the agency is quietly backing away from Zero Tolerance (while not admitting it), and replacing it with maximum limits of ECH7 allowed. Odd, if ECH7 is indeed an adulterant, how can FSIS ethically allow 8% or more of meat to harbor the pathogen? This is the logical consequence of bureaucrats and attorneys changing science-based protocol, and mandating the perverted imposter at all raw meat and poultry plants, even those which do not qualify for true HACCP designation.
On page 25 of the agency’s traceback recommendations the following statement is found: “FSIS also intends to conduct a study to test product from unopened containers or purge material (that is, remaining liquid, fat, and meat particles in containers or combo bins after trim contents have been removed) from suppliers’ product for E.coli O157:H7”. Such actions were previously taboo, as it would have allegedly constituted double jeopardy for the source slaughter provider, who feel that the product has already been inspected at the source, and most likely tested as well. I highly commend FSIS for taking this bold new stance. At a September 17, 2008 noon luncheon during an industry conference, then-USDA Under Secretary for FSIS Dr. Richard Raymond gave a speech. In it, he referred to an agency research project in which FSIS opened 24 pieces of intact boxed beef, and tested them all for ECH7. Shockingly, 8 of the 24 tested positive, and 6 of the 8 positives were from loin cuts. Please note that all 24 pieces were intact cuts, which are conveniently off-limits to FSIS for adulteration purposes. FSIS has not forgotten the importance of that research project, and intelligently concludes that it will commence testing product from unopened containers, meaning that intact cuts will no longer be immune from scrutiny. I think? Yet again, FSIS needs to clarify its now-confusing stance on intact cuts.
Nevertheless, eight positives out of 24 intact cuts should be a wakeup call to FSIS. Ho Hum. Twice, I’ve requested from FSIS copies of this agency testing experiment, but have received no records yet. Nor do I expect to! Egads, one third positives? If I were at the agency, I would also cover up this embarrassing evidence as well. If these facts are ever released, well………heads should roll at the agency. Don’t expect transparency on this issue.
A statement on page 27 states “FSIS recommends that establishments identify HEP criteria so that they can determine whether they need to withhold product from commerce when a HEP has occurred, because a HEP may indicate more widespread adulteration of product, beyond the product found positive (emphasis added)”. Wisely, FSIS now admits that when contaminated trim is detected, other products from the same lot (such as intact cuts) are also likely contaminated. If so, is the agency finally admitting that ECH7 which is on the surface of intact cuts might cause human sickness? This should be a no-brainer, a legal “res ipsa loquitor”, meaning that ECH7 speak for itself. ECH7 is a deadly pathogen, regardless of whether its host is trim, ground beef, intact cuts, lettuce, sprouts, etc.
FSIS’ bias against small, downstream plants is also seen in a letter issued by FSIS Assistant Administrator Dr. Kenneth Petersen. The letter, written June 2, 2005 includes this startling statement “I would expect a prudent establishment to have appropriate procedures to determine product acceptability prior to receiving the product”. Therefore, while FSIS is devising criteria establishing an upper limit on incidence of ECH7 positives at the source slaughter plants to determine if a High Event Period (HEP) has occurred, the downstream receiving plant is required to determine in advance if incoming meat harbors some of the 8% or more positives allowed by FSIS at the source slaughter plant. Plant managers incapable of detecting invisible pathogens before incoming meat arrives are imprudent, by agency definition.
God help us.
A statement found on page 31 of this agency list of traceback suggestions was “FSIS’s mission is not to screen the food supply through testing but to verify that safe and wholesome food is PRODUCED (emphasis added) through inspection activities”. Earlier in my comments, I referred to the fact that FSIS was placing inordinate emphasis on “shipping contaminated meat into commerce”, rather than production of unsafe meat. This agency statement on page 31 constitutes an admission by FSIS that its mission is to verify that unsafe meat is not produced. I cannot overstate the importance of this distinction. Rather than merely patting a slaughter plant on the back for detecting and diverting unsafe meat, while stating that the detection and diversion proves a plant’s HACCP Plan is working, FSIS must also ensure that unsafe meat is not being produced. Ongoing positive test results prove that the agency is NOT fulfilling its mission regarding the production of unsafe meat.
A statement on the top of page 33 says “A labeling claim asserting that beef trim has been sampled, tested, and found negative for E.coli O157:H7 will provide receiving establishments with information (emphasis added) regarding the sampling and testing of beef trim for that pathogen conducted by supplier establishments”. Information, yes, but admittedly incomplete. Please remember that source slaughter suppliers incorporate into their annual certifications the statement “Neither we, nor for that matter, anyone is able to guarantee pathogen free raw materials”. Such disclaimers are 100% accurate, since plants producing raw meat cannot guarantee they are devoid of pathogens. Therefore, beef trim arriving at a downstream establishment accompanied by a labeling claim stating that the trim had been sampled and tested negative for ECH7 has virtually no guarantee that it is safe. Realizing the low incidence of ECH7 in trim, testing for its presence is somewhat akin to searching for the proverbial needle in the haystack. To the chagrin of downstream further processing plants, FSIS’ public statements in recent years cast doubt on the value (if any) of the agency’s official USDA Mark of Inspection. FSIS Notice 05-09 includes this ironic statement “An establishment that receives, grinds, or otherwise processes raw beef products cannot conclude that E.coli O157:H7 is not reasonably likely to occur in its production process because the product it receives bears the mark of inspection”. Furthermore, in training materials entitled “Prerequisite Programs for E.coli O157:H7” supplied to the agency’s field force, the following statement can be found on slide #2 entitled “Basic Principles”. “Grinders with prerequisite programs should not rely on the mark of inspection to accept incoming product”.
Therefore, grinders find themselves in three dilemmas:
- Suppliers admit that they cannot provide pathogen-free guarantees on their products.
- FSIS itself admits that the Mark of Inspection has no connection with safe meat.
- When FSIS detects ECH7 at the downstream plant, in meat purchased from source slaughter providers, FSIS accuses the grinding plant with having a HACCP Plan Failure. FSIS nonchalantly ignores the fact that ECH7 was INTRODUCED at the source slaughter plant.
When the agency devised its faulty style of HACCP, FSIS must not have thought through these potential scenarios, which have played themselves out countless times across America. If the agency DID consider this eventuality, it should be ashamed by doggedly plodding on nevertheless, selling our industry and this nation a HACCP bill of goods. Which is precisely what occurred.
When ECH7 is detected and diverted at source slaughter plants, FSIS congratulates the plant because its HACCP Plan worked! But when ECH7 meat is detected at a downstream grinder plant, FSIS automatically accuses the plant of having a HACCP Failure, touching off an FSA, HACCP Reassessment, Corrective Actions, and typically an NOIE. This deceitful double standard imperils public health, ensuring future business for emergency rooms. Only FSIS-style “science” endorses such a derelict dichotomy in which the agency intentionally insulates the largest packers from performing corrective actions, while flushing small plants out of the federal system.
A case in point: FSIS sampling of ground beef for ECH7 at my plant on February 19, 20 & 21, 2002 resulted in three consecutive positives. The agency inspector closely witnessed my opening intact chubs of coarse ground beef I had purchased from an outside supplier, placing the meat into a clean grinder (no residual meat from previous grinds that day), and I did not commingle any other meat into the grinder. This was a perfect example of science-based sampling, precisely defining the ONE true source of meat being sampled. The inspector who collected the samples, and his vet supervisor, hand-wrote and signed a document explaining that the meat sampled originated from Est 969, which was the then-ConAgra plant in Greeley, CO.
So, how did FSIS respond to the three positives, and to the copious documentation compiled by its own inspection force as well as plant management?
- FSIS declared that my HACCP Plan had “Multiple Failures”.
- FSIS required over one dozen reassessments to my HACCP Plan over the next four months. Ironically, the FSIS District Office in Minneapolis summarily dismissed all my Reassessments as “Incomplete and Inadequate” UNTIL………Est 969 announced a 19.1 million lb recall. Only then did FSIS take its head out of the sand, and approved my Reassessment.
- FSIS removed inspection from my Raw, Ground HACCP Plan for four months.
- Simultaneously, FSIS took no enforcement actions against the source plant, which did not have to implement any corrective actions.
- FSIS declared that the field force documentation at my plant was but “personal opinion”, and “hearsay”. FSIS officials in District Offices and in DC have assumed authority to rewrite history from their remote locations, uncoupled from field-generated evidence.
- FSIS stated that the inspection force was not authorized to make the statements made in their hand-written letter.
While FSIS now allows inspectors to document source evidence at the time of sample collection, the agency’s current actions still mirror agency misbehavior at my plant a full ten years ago. While FSIS allows large source slaughter plants to experience 5% – 8% or more ECH7 positives before even considering the deleterious positives “might” constitute a High Event Period, hell hath no fury like FSIS when it detects but ONE solitary ECH7 positive at a downstream plant. The fact that the downstream grinding plant purchases 100% of its meat from a source slaughter provider is conveniently ignored by FSIS. Instead, the agency declares that the small grinding plant has a failure in its HACCP Plan, and dispatches an EIAO to the plant to conduct a FSA with a pre-determined NOIE in hand. When the small plant reminds FSIS that the meat was previously contaminated (with invisible bacteria) when it was purchased, FSIS responds by saying that the fact the plant allowed contaminated meat onto its premises constitutes a HACCP Plan Failure. This is precisely what FSIS management told me in 2002, and continues to tell other victimized small further processing plants today. All of which, by the way, are “imprudent”, by agency proclamation. This is an ongoing scandal, which will NOT be remedied by the agency’s newest Traceback ideas, which continue to insulate the SOURCE from accountability.
FSIS’ inane, nefarious and indefensible policies are a disgrace to the international scientific community, and to America’s image.
As incredulous as this sounds, FSIS officials from the Minneapolis District Office told me in early 2002 that since the coarse ground beef I purchased from Est 969 arrived at my establishment in boxes bearing the USDA Mark of Inspection, the meat had to be safe, because of the Mark. Chew on that awhile! Therefore, FSIS told me the ECH7 positive ground beef emanating from my grinder had to have been contaminated by my grinder or by an employee guilty of alleged insanitary personal hygiene, for three consecutive days no less. Bottom line: the USDA Mark of Inspection is essentially valueless, as are supplier certifications. Nevertheless, the plethora of FSIS requirements looks marvelous on paper. As long as FSIS-style deregulated meat non-inspection focuses primarily on paper flow, not on actual meat inspection, all the paperwork in the world cannot hide unsafe meat, as is proven by all our outbreaks and recalls while our office files are overflowing with daily HACCP records.
First of all, the largest slaughter plants will not legally challenge these agency Traceback suggestions for two reasons: (1) FSIS is graciously allowing the large source slaughter plants to experience 5% – 8% or more presumptive positives before the agency will even commence deciding if this spate of ECH7 contaminated meat might qualify for a High Event Period (HEP). Setting the food safety bar this low is an incredible gift to the slaughter plants. (2) When the EIAO and pertinent District Office are considering whether the high number of presumptive positives might constitute a HEP, FSIS allows itself 30 days to make this decision. This unjustifiable delay provides more than adequate time for the slaughter establishment to “negotiate” favorable terms with FSIS, allegedly proving that its HACCP Plan is working as intended.
When a slaughter establishment exceeds the agency’s HEP upper limits, the plant has an obvious problem which must be immediately addressed if FSIS is committed to public health considerations. Delaying an official decision for 30 days not only imperils public health, but reflects the agency’s fear of offending powerful large plants. This decision process should be concluded in no more than one week.
Neither FSIS nor the slaughter plants are concerned with the production of unsafe meat, focused instead on preventing shipment of unsafe meat into commerce. This conniving diversion of food safety focus is intolerable and unjustifiable, and must be changed. The mere fact that slaughter plants are experiencing high numbers of presumptive positives constitute irrefutable proof that our highly heralded multiple hurdle pathogen intervention systems are frequently incapable of handling high loads of manure on feedlot cattle. While ensuring that no unsafe meat is shipped into commerce is commendable, even more important is to ensure that slaughter plants’ interventions effectively produce sanitary carcasses. FSIS disagrees, as proven by its gift of 5% – 8% or higher incidence of presumptive positives.
FSIS is now duty bound to specifically state whether it considers ECH7 to be an adulterant when found on intact cuts. This charade has gone on long enough. FSIS must be brought to accountability, and transparency. There is always room for truth.
True HACCP requires zero positives. FSIS-style HACCP, as delineated in these newest agency Traceback suggestions, allow 5% – 8% or more ECH7 positives. Not only do these pathogen free passes continue to imperil consumers, they reveal the perverted and untenable foundational principles upon which the FSIS-style HACCP House of Cards has been constructed. Change is required.
Raw meat cannot comply with the agency’s foolish Zero Tolerance prohibition for ECH7. The fact that the agency now allows 5% – 8% or more ECH7 positives at large source slaughter plants constitutes a back door admission that FSIS no longer embraces Zero tolerance. FSIS must define its stance on Zero tolerance, one of many steps required for transparency………..and truth.
If indeed ECH7 is an adulterant, and if we are duped into thinking the pathogen can be successfully kept out of RAW meat, a High Event Period (HEP) occurs when but ONE ECH7 positive is detected. Allowing 5% – 8% or more positives in a day or shift constitutes a shameful agency abrogation of its public health mandate. Also, the industry’s ubiquitous disclaimer that a negative N60 trim test does not guarantee that the entire lot of trim is pathogen-free means that the 5% or 8% positive figure is artificially lower than the actual number of lots harboring pathogens.
FSIS-style HACCP is not true HACCP! FSIS used its version of HACCP as a Trojan Horse. Emblazoned across the horse were the words “Food Safety”. But inside the horse, the agency’s true goal was hidden, which is deregulation. This goal can be seen in the agency’s newest Traceback suggestions, allowing the large source slaughter plants 5% – 8% or more ECH7 presumptive positives before the agency is even authorized to consider commencement of enforcement actions. Even then, both the EIAO and District Office management must agree to authorize such actions after reviewing data for an unbelievable 30 days. The agency’s deregulation focus is also witnessed by the agency’s Advanced HIMP suggestions, which ostensibly will create safer poultry while FSIS gives 955 inspectors their walking papers. A smaller inspection force ostensibly equates with improved food safety. Deregulation rules the roost at the agency.
As long as FSIS is sacrosanct and inviolable, it remains unaccountable for its actions and poor policies. If for no other reason, Americans should demand removal of meat inspection authority from USDA based on agency statements in its recent list of Traceback suggestions. It is time again to consider combining all food inspection within one agency. Certainly not at FSIS, nor at FDA which has no experience with daily inspection.
Many of the laudable FSIS suggestions in this Docket are diametrically non-compliant with the agency’s four Pre-HACCP promises. We in the industry have done our part by implementing HACCP Plans, SSOP’s, GMP’s, etc. We are now confronted by a government agency which wants to dramatically change its role in this FSIS/Industry HACCP relationship. FSIS-style HACCP’s disconnect from true HACCP, coupled with these new agency traceback suggestions which are a little closer to reality, should lead us to discussing the removal of the 1995 Mega Rule, and start over again.
While FSIS-style HACCP has numerous, substantive differences from true HACCP, it nevertheless has some laudable HACCP principles which should be retained in a revamped meat inspection system. Microbial sampling, which was comparatively non-existent before the meat industry implemented HACCP in 1998, must be kept, but changed. True HACCP tested the process, i.e. every step of the kill floor, which are delineated in our Hazard Analyses. In stark contrast, FSIS-style HACCP has tested the final product. While testing the final product does have benefits, including keeping unsafe meat out of the food chain, focusing on product testing has obfuscated the true SOURCE of contamination. FSIS realizes this, which it hopes to partially resolve by improving tracebacks to the source.
When FSIS detects ECH7 in ground beef at a further processing plant, no one knows WHERE in the system the pathogen was introduced……….by intentional FSIS design. Obfuscation of valuable source evidence is the logical consequence of testing finished products, rather than testing each step of the process. FSIS avoids testing the process at the large kill plants, knowing that such testing would prove loss of process control at the source slaughter plant. This is yet another gift of FSIS-style HACCP to the largest slaughter plants.
FSIS’ desire for traceback authority flies in the face of the agency’s four Pre-HACCP promises, a Catch 22 situation caused by the agency’s deregulation of the industry’s largest plants. Deregulation has painted FSIS into a corner, emasculating it of authority even when confronted with ongoing, recurring production of unsafe meat at some abattoirs. The fact that this newest FSIS Traceback proposal gives the agency 30 days to respond to an EIAO’s recommendation shows that FSIS is tentative, treading on thin legal ice caused by its deregulation of the big packers by allowing the industry to police itself, absent any agency command-and-control authority.
Let’s construct a new meat inspection/production system which incorporates HACCP principles, but still allows organoleptic (that’s not a 4-letter word) inspection. A new system must provide the agency unrestricted access to all production activities in a plant, and immediate daily access to all company records, including lab test results, with no advance notice required. FSIS must be empowered to act quickly and decisively when it observes fecal contamination on carcasses, intact beef cuts, boneless trimmings and ground beef, with no artificial restrictions. FSIS must also be authorized to act quickly (no 30-day delays) when confronting ongoing adverse lab results.
Plants must also have expedited access to swift and proactive legal recourse when targeted by ill-meaning and power hungry agency employees. Believe me, they exist, although in small numbers. The need for such industry access to expedited legal recourse cannot be overstated. Abusive and unethical agency behavior against legitimate Montana plants in recent years should be unconscionable in a democracy. FSIS however has morphed into a fourth branch of government, devoid of checks and balances. Much has been demanded of the industry, while FSIS has enjoyed carte blanche authority to hagride small plants. By the way, FSIS employees nationwide have explained to me how agency mistreatment of small plants is NOT unique to Montana.
To be truly transparent, FSIS must author and publicly release educational materials explaining the (1) SOURCE of enteric bacteria (in all likelihood, the source abattoir). The materials must also explain how (2) cross contamination occurs in such diverse locations as:
- The SOURCE slaughter plant
- Downstream further processors
- Consumers’ kitchens
- Hospital and nursing home cafeterias.
In the absence of such erudite educational materials, consumers get the impression (as desired by FSIS) that the downstream locations (b – d above) are the true culprits, ostensibly INTRODUCING ECH7 into food. This is a terribly important distinction, which FSIS is capable of delineating to Americans, if it wants to. It doesn’t.
We need a modern-day Upton Sinclair to reveal systemic problems with FSIS-style HACCP’s deregulation of the industry’s largest players.
As a task force designs a new inspection system, which incorporates microbiological testing as a vital component, it is imperative that a large percentage of the task force be composed of scientists and microbiologists from outside FSIS. The agency’s autocratic bastardization of true HACCP principles can no longer be countenanced. FSIS must be denied the opportunity to unilaterally author another illegitimate HACCP imposter. A truly science-based system must be designed by recognized individuals with scientific backgrounds, not by politicians and lawyers. If FSIS is concerned with legal challenges from big packers, by all means, go to court! If industry giants with deep pockets can use the courts to push through meat inspection policies to protect their bottom lines instead of promoting public health, well, let’s disband FSIS and totally turn inspection over to the industry. Some feel that FSIS is headed that way already, as is allegedly seen in the agency’s advanced HIMP protocol.
Several times in this docket, FSIS stated “In response to comments”. While the agency’s willingness to listen to suggestions is indeed commendable and absolutely essential, its unwillingness to unilaterally implement long-overdue traceback changes is reprehensible. I’ve been negotiating with FSIS since February, 2002, suggesting it aggressively implement meaningful protocol enabling traceback to the SOURCE, with precious little success. Every activity based in science (not political science) will leave no stone unturned to determine the SOURCE of problems and/or successes. Although a determination of the SOURCE of contaminated food, and requiring corrective action at the SOURCE (not the destination) is common sense and should not be subject to disputation, FSIS has knowingly drug its feet on this issue, paralyzed with fear of litigation.
We desperately need FSIS management with the courage and foresight to implement common sense policies without always having to (a) request and then (b) respond to comments. The greatest leaders of our country energetically pursued the common good, fearless of potential litigation and capable of making decisions without first obtaining public and industry approval. Tracebacks to the source, and enforcement actions at the source fall into the category of the need for policies to be made expeditiously, if we have a greater concern for public health than for the threat of litigation.
Respectfully submitted by John W. Munsell, Manager
Foundation for Accountability in Regulatory Enforcement (FARE)
Miles City, MT
May 17, 2012