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Tracebacks and USDA: Mutually Exclusive?

On Aug. 3, 2011, U.S. Agriculture Secretary Tom Vilsack gave a speech in Milwaukee that included the following statement:

“In 90 days, I expect the agency [FSIS] to announce the first step in transforming our traceback policy”.

The USDA”s Food Safety and Inspection Service announcement is now six weeks overdue, and the agency has yet to publicly announce even “THE FIRST STEP” in transforming its mostly nonexistent traceback policies. It would be helpful to consider historical actions taken by FSIS regarding tracebacks, to place current agency inaction within a historical perspective.

On Jan. 26, 1998, the largest plants implemented their Hazard Analysis and Critical Control Points (HACCP) programs.

In March, 1998, FSIS issued a document entitled “Guidance for Beef Grinders to Better Protect Public Health.” This guidance includes 21 references to the terms traceback, trace forward, trace, tracking, tracing, tracking system and traceability.  In 1998, FSIS fully endorsed the concept of tracebacks … in writing.  

After a series of recalls in 2001, FSIS microbiologist Carl Custer suggested that FSIS should trace back trim sources and see what other grinders had received trim from those sources.  FSIS did not act on Custer’s suggestions.  Therefore, in 2003, Custer enhanced the argument and sent his suggestion to his director, who endorsed it and forwarded it up the agency chain of command.  A few days later, the director verbally notified Custer  “I’ve been told FSIS won’t go on witch hunts.”  In other words, the agency would not trace back to the source!

In January, 2002, my plant recalled 270 lbs. of ground beef potentially contaminated with E. coli O157H7.  When I suggested to FSIS that the agency trace the contaminated meat back to the source, it refused.  The agency refused to even allow inspectors to document the origin of meat being sampled at the time of sample collection.  However, on July 26, 2002, the FSIS Office of Field Operations (OFO) sent an email to all its district offices that included the following statement:

“As discussed in our conference call on July 23, 2002, the following are the actions each District must take when an FSIS E. coli O157:H7 monitoring sample is taken for ground beef.  At the time the sample is taken, the IIC [Inspector] will obtain from the establishment, the name, point of contact, and phone number for the establishments supplying the source materials for the lot of ground beef being sampled.”  

The two top OFO officials at this time were William Smith, and Dr. Kenneth Peterson.  Both officials are still at FSIS.

On Oct. 5, 2002, at a joint FSIS/industry public meeting, an agency official revealed that the July 23 procedure change had been rescinded “for legal reasons.” Therefore, inspectors were no longer allowed to document the origin of meat being sampled at the time of sample collection. In reality, FSIS rejected the concept of tracebacks.  

On Dec. 11, 2002, a Senate field hearing was conducted in Billings, MT, which was entitled “Food Safety Recall Procedures.” The panelists included the above-mentioned William Smith, and me.  During the hearing, I suggested that whenever an inspector collects a ground beef sample for USDA lab analysis, both the inspector and a plant representative should jointly document the source of the meat being sampled.  OFO’s William Smith was asked for his response.  The official transcript shows that Smith responded “…we could have inspectors doing more important things.”  (Yes, than telling the truth!)  Mr. Smith also stated “…a number of packers would also be very upset about us collecting information on negative [adverse] findings.”  Indeed, the large source slaughter plants would be upset if agency inspectors sampled meat from source slaughter providers at downstream further processing plants.

In this Senate hearing, a top agency official unwittingly admitted that FSIS opposes tracebacks to the source … in the real world.  

Roger Viadero was the USDA Inspector General from 1994 – 2001.  In a Feb. 15, 2004 article in “Meat News,” Viadero made the following statement:

“For food tracing is also a tenet of the Bioterrorism Act of 2002.  By law, all entities involved in the production, distribution or sale of food products in the U.S. must be able to track their products – and all components thereof – two steps back and one step forward in the supply chain.”  

Therefore, any artificial attempts by either FSIS or the industry to prevent tracebacks two steps back are direct violations of the Bioterrorism Act.  

On Dec. 1, 2009, FSIS officials participated in a public meeting with consumers.  During the meeting, an agency official stated that when a public outbreak is occurring, FSIS will perform tracebacks to the origin.  However, when a lab sample shows that the meat tested is laced with E. coli O157:H7, the agency DOES NOT perform a traceback to the source if no outbreak has occurred. How important is this agency policy? Consider this:  from Jan. 1, 2009 through Nov. 30, 2010, FSIS found 64 samples of ground beef that tested positive for E. coli O157:H7.  Of these 64 positives, 29 samples were collected from plants that purchased meat from only one source slaughter supplier. This provided FSIS with 29 golden opportunities to trace contaminated meat back to only one source slaughter provider. But FSIS refused to conduct tracebacks in all 29 cases. Why? Because there was no outbreak involved.  

The largest plants implemented HACCP on Jan. 26, 1998. Now, almost 14 years later, FSIS continues to refuse to perform tracebacks to the source even when possessing lab reports revealing E. coli O157:H7 in ground beef emanating from only ONE source slaughter provider establishment. Tracebacks to the source, which can pose problems, can nevertheless be accomplished; yet, FSIS willfully circumvents science-based tracebacks.  

FDA and FSIS jointly sponsored a traceback hearing in Washington, D.C. on Dec. 9 and 10, 2009. The FSIS deputy under secretary for FSIS, Jerold Mande, made the following comments:

“…improving product tracing has become a priority for the Obama Administration.”

“Each day, FSIS and industry tests products for microbial contamination.  Efforts to determine the source of positive product that an establishment produces need to be robust to prevent contaminated product from reaching consumers.”

“…we need to be looking toward a seamless tracing system that reaches throughout the nation and the world.”  

Again, FSIS endorses the concept of tracebacks to the source … in theory.

FSIS then hosted a public traceback hearing on March 10, 2010.  The brief, 31/2 hour meeting covered little fresh ground, other than to say that whenever a lab sample tests positive, FSIS would send an agency official (called an EIAO) to the impacted plant as quickly as possible to conduct a closer scrutiny of plant operations.

FSIS issued Notice 58-10 on Oct. 8, 2010 in which it authorized, in fact required, inspectors to collect source supplier information at the time of sample collection. This is the same procedure which was on the previously mentioned July 26, 2002 FSIS email to its district offices, but which was quietly rescinded only two months later.  Thus, FSIS required 8 additional years to consider such science-based sampling protocol before officially endorsing what should have been a foundational premise of its meat sampling methodology. This artificial delay is unconscionable, and i
n fact imperiled public health in the interim.  

The meat industry, FSIS, and public health departments all employ epidemiologists who continually search for causes of outbreaks, hoping to control the distribution of unsafe food.  FSIS’ artificial restrictions that limit traceback opportunities create an unnecessary hurdle for epidemiologists, making a determination of the SOURCE of contamination unnecessarily difficult.  If FSIS is allowed to maintain its artificial traceback barriers, how will America respond to future bioterrorist activities?  

FDA’s David Atcheson issued a report on Dec. 8, 2011 discussing FDA’s commitment to the need for preventive control requirements.  His article made at least 18 references to prevention and preventive strategies, including the need to understand the cause.  FDA appears to have a stronger commitment to prevention at the source than does FSIS, which focuses on corrective (after-the-fact, reactionary) actions at downstream further processing plants, after the pathogens have been let out of the slaughterhouse barn.  

Dr. Elisabeth Hagen heads up USDA’s Food Safety Inspection Service, enjoying my full endorsement.  Her intentions for watershed changes became obvious in her very first public speech after she assumed the agency’s top position.  The speech was given on Sept. 23, 2010 to the National Food Policy conference in Washington, D.C.  She discussed three areas which were to be her focus at FSIS. Her comments included the following:

“First, is prevention – it has got to be the foundation of everything that we do. Our food safety system, the way it currently works, relies too much on reaction (emphasis added) to problems to make people safe.”  

“And FSIS continued to evolve into what it is today:  an agency that is working hard to get to a truly preventative system.”

“Traceback. How do we get our policies for traceback to the source fully aligned with our goal of prevention? We also need a more effective traceback policy for contamination that we find through our regulatory sampling programs, if we want to have a truly preventive system.”

“One of our most powerful tools is data. We need to have the right data. We need to be able to gather the right data.  And then we need to analyze it in a way that leverages our vast inspection force to protect the public.”  

Subsequently, on March 15, 2011, in a speech to a Congressional subcommittee, Dr. Hagen stated:

“Prevention is the guiding principle of USDA’s Office of Food Safety and the Food Safety Inspection Service.”

Although Dr. Hagen admitted in September 2010 of the need for prevention, rather than reaction, and the need for tracebacks, and the ability to gather the right data, why, at the late date of Aug. 3, 2011, did Secretary Vilsack give FSIS 90 days to commence transforming its traceback policy?  Why hadn’t the process begun months before, in fact, years before?  FSIS unwillingness to trace back to the source is a systemic problem within the agency, which perhaps neither Dr. Hagen or Secretary Vilsack may be able to reverse.  FSIS lifer bureaucrats are paralyzed with fear of litigation from the industry’s largest slaughter establishments, if the agency were ever intrepid enough to trace back to the source.

In a Dec. 11, 2011 Food Safety News article by Dan Flynn, reference was made to Missouri’s state health director Margaret Donnelly, who told the Missouri House Appropriations Committee that in about half the outbreaks of foodborne illness, the source is never found.  The article also stated that this means that about half the time we all pay, in higher insurance premiums and higher taxes. I’d like to expand on this statement.  It also means that since the source is not determined half the time, and corrective actions not implemented, we are virtually guaranteed ongoing outbreaks. Since we don’t force the source to clean up its act, consumers pay the price. Sound familiar?  

So, where is FSIS today? To its credit, it has finally allowed its inspectors to document the origin of sampled meat at the time of sample collection. FSIS still refuses to get involved in “witch hunts,” that is, refuses to engage in traceback activities that would likely end at the doorstep of the industry’s largest slaughter plants. Why? Successful tracebacks would reveal that the industry’s largest slaughter plants continue to ship an unacceptably high amount of pathogen-laced meat into commerce, and would reveal the agency’s underwhelming oversight at these behemoth slaughter establishments.

My concern is that FSIS’s unwillingness to author even a preliminary “first step” in transforming its traceback policies reveals a systemic agency opposition to tracebacks to the source. If Secretary Vilsack had asked me (or countless others) to author initial recommendations to improve FSIS traceback protocol, viable suggestions from dozens of further processing plants and FSIS field personnel could have been accumulated and submitted to FSIS within 30 days. This is not rocket science. But it does require a commitment to true science, and common sense, absent artificial bureaucratic restraints.     The 90-day mandate was overly liberal, a time frame that has been exceeded by an unbelievable six weeks already. Is it possible the agency’s pious proclamations endorsing prevention and tracebacks were merely PR ploys? Since Secretary Vilsack has not held FSIS accountable for its noncompliance with his overly generous 90-day mandate, could it be possible that Secretary Vilsack and the Oval Office are accomplices with FSIS, preferring not to engage the industry’s largest slaughter plants?  

America’s consumers, taxpayers and public health deserve better.  

Traceback is dead at USDA.  

Secretary Vilsack, let us hear from you … soon!


John Munsell oversees the Foundation for Accountability in Regulatory Enforcement, FARE.  His website is www.johnmunsell.com

© Food Safety News
  • Michigan State University conducted a successful pilot project mid of this year funded by USDA to trace beef back to the source from a smart phone. Here is a link to read more:
    ScoringAg provided the database. Meat traceback needs to happen for the consumer’s health and the nation’s ability to lower the cost of health care.

  • Jess C. Rajan, Ph.D.

    “FSIS issued Notice 58-10 on Oct. 8, 2010 in which it authorized, in fact required, inspectors to collect source supplier information at the time of sample collection. This is the same procedure which was on the previously mentioned July 26, 2002 FSIS email to its district offices, but which was quietly rescinded only two months later.”
    Effective “trace back” requires reliable information collection and record-keeping. For information collection, Federal Agencies and their employees must follow applicable laws (44 U.S.C.) and regulations (5 CFR § 1320).
    Authorized/formal information collection would require review/approval from the OMB. Usually, Agency’s Forms with OMB control number(s) would be used for consistent information collection.
    FSIS Notices are temporary internal documents written for the use of FSIS employees and are scheduled to expire no later than one year from the issuance date. Therefore, FSIS Notice 58-10 would have expired in November 2011. Unlike the Agency’s Federal Register publications, FSIS Notices do not undergo regulatory reviews by the USDA’s Office of General Counsel and the OMB.

  • jmunsell

    Jess, Dr. Dan Engeljohn, who heads up the FSIS Policy Dept, notified me this morning that although Notice 58-10 has technically expired, inspectors are to continue documenting all source evidence at the time of sample collection. The Notice is being rewritten, and will be incorporated into a new version of Directive 10,010.1 next year. John Munsell

  • Minkpuppy

    Dr. Rajan,
    From a field inspection standpoint, the instructions in Notice 58-10 and several other notices are very much still in effect. Unless FSIS specifically cancels the “expired” notice, it then becomes Agency policy and field inspection personnel are required to continue following those instructions even though the notices are allegedly expired. (This comes straight from my FLS who got it straight from D0 and DC).
    Also, PHIS has a mandatory Supplier Tracker task that must be completed whenever a E. coli 0157:H7 sample is submitted to the lab. The supplier information is entered directly into the PHIS database and MOIs are generated. I don’t know if OMB is involved but it is definitely a formal information collection.

  • John Munsell

    Jess, Dr. Dan Engeljohn, who heads up the FSIS Policy Dept, notified me this morning that although Notice 58-10 has technically expired, inspectors are to continue documenting all source evidence at the time of sample collection. The Notice is being rewritten, and will be incorporated into a new version of Directive 10,010.1 next year. John Munsell