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Marler Blog Providing Commentary on Food Poisoning Outbreaks & Litigation

Lets give the CDC and State Health Departments the tools to stop outbreaks faster

In all the heat that has been generated against House Bill 2749 and Senate Bill 510, two sections (Sec., 121 in HB 2749 and Sec., 205 in SB 510), are the babies that have been thrown out with the bathwater. If passed these sections have the greatest opportunity to fundamentally change how food is produced in the United States.  Here is the reality, most outbreaks are figured out AFTER the outbreak is over (or nearly so), and most recalls are generated by ill consumers (a.k.a., canaries with grocery carts).

US-CDC-Logo_109309.pngRead those sections for yourself. However, here is my take on them:

Both Bills opening provisions are essentially the same except the Senate version excludes in Section (E) (House version (b) (5)), “including working toward automatic electronic searches” and “in order to identify new or rarely documented causes of feed-borne illness and submit standardized information to a centralized database.” The remaining provisions of the opening provisions are identical. The Secretary of HHS (remember these bills ONLY relate to FDA and the products it oversees) “acting through the Director of the Centers for Disease Control and Prevention, shall enhance food-borne illness surveillance systems to improve the collection, analysis, reporting and usefulness of data on food-borne illnesses…”

So, how do Sec., 121 in HB 2749 and Sec., 205 in SB 510 accomplish that?

– coordinate Federal, State and local systems, including complaint systems and networks of public health, food regulatory agencies and labs;

– facilitate sharing of findings between FDA, USDA, State and local agencies, and the public;

– develop improved epidemiological tools;

– improve systems that attribute an outbreak to a specific food;

– expand fingerprinting and other detection strategies for food-borne agents;

– allow public access to aggregated, de-identified surveillance data;

– publish findings at least yearly;

– rapidly initiate scientific research by academic institutions;

– integrate surveillance systems and data with other biosurveillance and public health entities.

Also, not in the House Bill is the creation of “PARTNERSHIPS” which appears to actually be a “working group of experts and stakeholders from Federal, State and local food safety and health agencies, the food industry, consumer organizations and academia.”

SB 510 Section 205 (c) in most part is a restatement of the above to-do list with the addition of “strengthen[ing] the capacity of State and local agencies to carry our inspections and enforce safety standards.”

Section 205 (d) requires the Secretary to (within a year) complete a review of State and local capacities, including staffing levels, laboratory capacity, outbreak response, inspection and enforcement functions

So, why did I say, that these surveillance provisions “have the greatest opportunity to fundamentally change how food is produced in the United?” Having accurate information makes for better decision making by manufacturers, consumers and regulators. However, in addition, giving the CDC and State Health Departments the tools to stop outbreaks faster prevents a small outbreak from becoming a large ones (most outbreaks are figured out AFTER they are over) and allows for being much more accurate at pinpointing the offending food product and manufacturer much more accurately (no more “its tomatoes, oops, its peppers.”).

Perhaps HB 2749 and SB 510 are done, but there is no reason not to move Sec., 121 and Sec., 205 forward.

  • John Munsell

    On May 9 & 10, 2002, a “Pathogen Reduction Conference” was conducted, including representatives from CDC, FSIS and many other organizations. CDC was represented by Dr. Robert Tauxe. The question was posed of Dr. Tauxe “Does USDA share PFGE information on recalled product with CDC?” Dr. Tauxe’s reply was “We have been wanting to get that from the USDA for quite a while”.
    The overriding question posed to USDA/FSIS this century has been the agency’s unwillingness to expeditiously share all outbreak evidence and lab test results with the entire food safety continuum in the country. What does FSIS have to hide?
    Let’s be candidly blunt with unrestricted truth here: if FSIS were to ever develop the courage to expeditiously share evidence in its control, tracebacks to the SOURCE of contamination would quickly occur. The consequences to FSIS would be devastating, including:
    1. The SOURCE of contamination would have the agency in court within days, to restrict the free flow of evidence. Since the Big 4 packers slaughter 88% of our feedlot steers and heifers, one can assume that 88% or more of hot meat emanated from within their kill floors.
    2. Tracebacks to the SOURCE would reveal that FSIS is asleep at the wheel, by intentional agency design, at the BIG packers.
    3. Tracebacks to the SOURCE would reveal that the USDA-Style HACCP Hoax is not working, but in fact is directly responsible for our ongoing outbreaks and recurring recalls, gratis the agency’s deregulated non-inspection environment gifted by HACCP.
    4. Tracebacks to the SOURCE would reveal that the big packers continue to ship an alarming amount of pathogen-contaminated meat into commerce, in containers bearing the official USDA Mark which states “USDA Inspected & Passed”. Yup, we now have an agency which allows USDA Inspected & Passed E.coli pathogens to enter commerce, and outbreaks are now the exclusive responsibility of negligent consumers.
    Mr. Marler, as long as USDA/FSIS continues to fabricate endless excuses justifying their tardy release of pertinent public health information, you are absolutely right that the cause of outbreaks will only be revealed SUBSEQUENT to the termination of the outbreak.
    Again, our primary enemy here is not E.coli, but a recalcitrant FSIS which intentionally withholds vital information which would benefit the twin towers of public health and food safety. It is abundantly true that under the leadership of Dr. Richard Raymond, the agency made great strides to improve its timely sharing of pertinent evidence. But the larger picture is why in the dickens has the agency EVER restricted the free flow of timely data?
    John Munsell

  • Rich Cardinale

    Bill,

    Your right on target with this as i found out first hand. Forewarned is forearmed and this is the perfect place for it.

    Thanks

  • Jim Schmidt

    I agree with you Bill. Interesting and appropriate comments. The only thing I would like to point out is that the organizations with the least amount of funding that are always strapped for funding to do continuing education and the like are the ones that usually find the outbreaks.

    It’s me or my counterpart following up on one of many foodborne illness complaints. Would stopping it at the source help? You bet it would. When there are nation wide recalls of food who goes into the facilities to make sure the product is gone or to educate the owners on what needs to be done? I would bet it is seldom the Feds and depending on your State it is probably your County or Municipal/City worker.

    I started in this field (REHS) in 1991 and I said it then I’ll say it now, all levels of government need to be better integrated. It has gotten better since 1991 but not as much as it should.

  • Dr. Samuel M. Fassig

    Disclaimer: These are my opinions and not necessarily those of my employer
    “Let’s give the CDC and State Health Departments the tools to stop outbreaks faster.” That message is spot on but may not happen in this lifetime.
    Mr. Marler has indicated: “Most recalls are figured out AFTER the outbreak”
    I would change the “most” to”a number of” recalls the public hears about do rely on clinically ill patients playing the role of sentinel for foodborne illness events. I do not have accurate statistics regarding what percentage of recalls or outbreaks this segment includes but there is more to the story than media accounts or number of lawsuits. There are those significant recalls the public never hears about.
    In the case of meat inspection there has been quite a role reversal in the packing industry since the adversarial days in the 1980’s when FSIS had a position of responsibility for product safety and wholesomeness. Today, with the advent of the application of HACCP, the processing plant bears the ultimate liability and responsibility to produce a safe, unadulterated, wholesome product. Operators now have assumed control of and responsibility for their own processes and FSIS’ shift in how it does inspection has given it a legitimate claim to the title of USDA’s public health agency. FSIS is there to assure the plant is doing what they say they are doing and assist them in producing safe products.
    HACCP today provides the foundation for most of what FSIS is doing to reduce pathogens. The pathogen reduction strategies for Listeria, E. coli O157:H7, and Salmonella are all based on interventions for them being built into plants’ HACCP systems. However, there is that “voluntary” thing attached to parts of inspection process. In my experience, the inclusion of “voluntary” is largely political; without it, federal agencies would have a hard time getting many programs off the ground.
    Currently, FSIS cannot inhibit a company’s ability to conduct business. Under that policy, a plant has the right to ship product to another inspected plant with a hold tag produced on pre-shipment inspection if say, the E. Coli tests results are not back (plant testing or FSIS directed testing) indicating the receiving plant must maintain control of the product until results are known. Or, it can voluntarily hold it in its own facility. It does happen that said product is shipped (perhaps no more room in the cooler) and the receiving plant instead of holding it, will go ahead and comingle that “voluntary hold” product with current production and it ends up in commerce before testing results known. Should a positive test result occur, FSIS may initiate the recall process by informing a firm that adulterated product has been identified in commerce. FSIS does not have, and is not seeking, mandatory recall authority. FSIS retains the right to detain or seize product to protect consumers should the plant not take action. The tonnage involved (especially in raw ground beef) can be staggering and not public knowledge. Plants that take such a risk are moving to smaller tonnage lots to minimize how much product will be recalled and destroyed. I am not an attorney, but am doubtful such information is freely available to litigators from packers.
    How food service handles and prepares food is another area often overlooked by the media but tied to using ill patients as sentinels. Cross-contamination in retail delis may be a significant source of Lm contamination and only local health departments may be aware. Their epidemiology departments are often small, frequently understaffed, budget challenged and usually depend on the incidence of human illnesses to determine the source. Handling of raw product, pre prepared product, restaurant or deli preparation may be investigated. It is only after such assessment is determined that a recall may be initiated. Thus, it becomes a look backward.
    In the case of shell eggs, perhaps there is a lack of agency oversight-
    • The turf war between FDA and FSIS exists and rumors regarding their merger under one agency or becoming part of Homeland Security persist.
    The recent egg recall demonstrates the current statutory framework for egg safety established by Congress and presents a fragmented system of oversight. Currently FSIS shares statutory authority for egg safety with the Food and Drug Administration (FDA). However, as history repeats itself, risk assessment has come in response to an increasing number of human illnesses attributed to the consumption of contaminated eggs. APHIS is in the picture as it administers the National Poultry Improvement Plan (NPIP), which certifies that poultry breeding stock and hatcheries are free from certain diseases. NPIP participation is necessary for those producers that ship interstate or internationally but it too is a “voluntary” program.
    The USDA Reorganization Act of 1994 set the stage for FSIS involvement in egg products inspection by transferring this responsibility from AMS to FSIS.Under the Egg Products Inspection Act (EPIA), FSIS is responsible for continuous Federal inspection in plants processing liquid, frozen, and dried egg products
    Since Salmonella can be in the hen, the feed, the inside of the egg in the shell or on the shell surface, it would seem having three agencies in the inspection picture complicates preemptive intervention.
    Bottom line challenge: for more than the 36+ some years I have been a veterinarian – clinicians, drug companies and producers have cried out for some system that indicates the accurate reporting of the incidence of animal diseases without jeopardizing an individual’s rights anywhere along the line. Private Veterinary medicine does not have the ability (political influence, financing, or advocates on the ground) to standardize and centralize such data at this time.
    Practitioners use a mix of private, university, federal and state laboratories if available, and in-house testing to assist in making a diagnosis. Post mortem examinations and assessments are not mandatory and many producers will not pay for such services or even lab work. Academic pathology laboratories cannot agree on what formats to use much less standardized tests. There is no mandatory requirement to share with the state or APHIS any disease not considered reportable or notifiable (usually foreign animal diseases- FAD’s) and even those lists vary from state to state. Meaningful data mining is unavailable due to lack of standardization. Pharmaceutical companies would very much like to have such incidence of disease data as it would be helpful in determining production runs, market size and market shares, but are unwilling to bankroll such a project. I am sure Congressional Budget Office (CBO) scoring would be out of sight for setting up some system – as if it was “voluntary”, I doubt there would be enough players to make it statistically sound.