In numerous press releases by the FDA promoting the FDA Final Rule on egg-borne Salmonella enteritidis infection, the agency quotes “as many as 79,000 illnesses and 30 deaths per year from consumption of SE-contaminated eggs”. The commissioner of the FDA, Dr. Margaret A. Hamburg has publicly stated that the rule “will prevent thousands of serious illnesses from salmonella in eggs”.

This commentator is a strong supporter of SE egg quality assurance programs such as those developed by Pennsylvania and in the case of one cooperative marketing a nationally branded specialty egg produced by a chain of U.S. franchisees. Their program – which mandates vaccination, biosecurity, rodent control and frequent monitoring – actually preceded the FDA Final Rule by three years and was introduced on the basis of prudence and a desire to enhance food safety.

I challenge the FDA, CDC, USDA or any other federal agency to substantiate the widely exaggerated figures relating to egg-borne salmonellosis and specifically SE infection. A review of U.S. statistics relating to food-borne disease outbreaks over the past six years shows approximately 30 documented outbreaks of egg-borne SE infection among consumers each year. This cannot under any scenario be reconciled with the FDA SE Rule contributing to “79,000 fewer illness and 30 fewer deaths per year”.

There is a broad sentiment in the industry that the FDA Final Rule was introduced by the current administration in unseemly haste by operatives ill-equipped to understand the implications and costs of their actions to the industry and consumers. A progenitor of the Final Rule languished on the shelf for many years during the Bush Administration as the problem of egg-borne SE, which emerged during the late 1980s, had all but been resolved by the mid-1990s.

Effectively, the requirements laid down in the Final Rule which relate to biosecurity, elimination of SE from successive generations of breeding stock, vaccination, monitoring and post-packing refrigeration were in place prior to the introduction of the Final Rule. Increasing the frequency of monitoring of flocks for the presence of SE to include mid-cycle and post molt assays is commendable and this approach has in fact been used by many producers at the request of QSRs.


From an epidemiologic perspective, more frequent assay as mandated by the FDA is necessary and justified even in vaccinated flocks housed on farms with no history of infection. The previous monitoring program incorporated in an industry-sponsored initiative requiring one test of mature hens before depletion was ineffective in diagnosing SE and was patently self- serving. In retrospect it is this commentator’s opinion that had the entire industry voluntarily adopted the Pennsylvania program, consumer confidence would have been enhanced and there would have been no need for the FDA Final Rule.

The continual repetition of misleading and distorted statistics to justify the action of agencies such as the FDA confuses consumers and detracts from the credibility of the federal government. Data relating to food-borne diseases frequently includes viral and bacterial infections acquired from contaminated drinking water which is unrelated to food. There is also a tendency by the FDA and public health authorities to deliberately confuse SE infection, which is specific with respect to the vertical route of transmission through eggs from infected flocks and paratyphoid salmonella infections which predominate and have different vehicles and modes of transmission. These differences relating to etiology and epidemiology obviously influence the approach to surveillance and control.

It is obvious that industry, academia and regulatory authorities must cooperate in determining the impact of specific pathogens in relation to food products and should lead to jointly develop programs of prevention and suppression. Federal agencies should be obliged to issue scientifically based, realistic and cost effective recommendations and rules which must be enforced.

Deliberate distortion of epidemiologic data and statistics to justify an action which at best is based on good intentions and at worst, political expediency is sophistry. I challenge those at the FDA responsible for the Final Rule to justify its inflated figures relating to the incidence of SE and to dispense with “educated assumptions” (read “fudge factors”). If there is no substantiation for these inflated rates of infection, officials should be factual in their congressional testimony and public statements and their press releases should be devoid of speculative data.