Assessing the FDA Final Rule on SE
Now that the FDA Regulation to Prevent SE in Shell Eggs during Production, Storage and Transportation (the “Final Rule”) has been in effect for eight months it is appropriate to review the impact on our industry. At the outset I would risk being considered a heretic by stating that the Final Rule has been beneficial and in retrospect will eventually be viewed favorably by producers.
The immense cost of the August 2010 recall and the expense of complying with regulatory imperatives have resulted in a new respect for egg safety. For too long the U.S. egg industry followed a self-serving and inadequate program developed, implemented and fostered by their producer organization. In the defense of the UEP, their Board has recognized the magnitude of losses associated with the market collapse following the recall of eggs produced by the Iowa operations owned by Jack Austin DeCoster. The UEP has now embarked on an initiative to develop a more comprehensive program of environmental surveillance, vaccination and biosecurity.
Although this is a classic case of closing the stable door after the horse has bolted, it nevertheless reflects a change in attitude that is encouraging. Incidentally, it does not take a panel of experts months to develop an appropriate egg-safety program. Political considerations aside, any of five poultry health professionals could develop a program in 15 minutes and agree on the procedures required. It is a matter of record that a U.S. Franchise organization marketing a nationally promoted and distributed specialty egg developed and implemented a program superior to the FDA requirements for testing and which incorporated compulsory vaccination during the mid 2000’s.
What are the benefits from the Final Rule? There is a heightened concern over introduction of SE into farms and multi-age complexes which have been shown to be free of infection. The cost of an environmental positive with or without subsequent confirmation through testing egg pools is high. Expenditure on protective clothing, rodent control, disinfectants and upgrading the management of biosecurity are relatively low when viewed against the alternative of SE positive flocks. The losses associated with diversion and decontamination following depletion of SE positive flocks are considerable. Poultry health professionals are now dealing intensively with adapting known principles of biosecurity, performing benefit- to-cost evaluations and assisting producers to upgrade programs of rodent control, vaccination and biosecurity.
We still have a long way to go especially in some operations where management really has not yet adapted to the realities of a regulatory environment dominated by adherence to the Final Rule. Anyone in a position of authority in a company that considers that intensive and meaningful prevention and control measures are unnecessary or too expensive might consider recent history and if still unconvinced either retire or choose another line of work.
Admittedly the Final Rule was implemented too quickly in response to the political demands of the Administration for a rapidly implemented food safety initiative which had the potential for positive publicity. Personnel involved in drafting the Final Rule were abysmally ignorant of the advantages of PCR technology or the value of vaccination and were equally unprepared to carry out inspections and audits. The problem was further exacerbated by failure to heed the advice of experienced poultry health professionals during the submission stage prior to publication of the Final Rule. In the intervening eight months since the introduction of the Final Rule, both the egg industry and the FDA have learned a considerable amount concerning the detection, control and prevention of SE infection in flocks.
The simple expedient of preparing the statutory detailed SE Prevention Plan for a company is a beneficial exercise since this task generally demonstrates defects in biosecurity and vaccination and other management practices which predispose flocks and complexes to infection. Had we not been faced with the realities of the Final Rule it is doubtful whether the majority of the industry would have implemented the changes which are now evident in visits to farms and discussions with owners and managers.
As one looks back on the past eight months there is a sense of gratification from the relative paucity of flocks identified as being infected as denoted by environmental monitoring or egg pool assays, even given the relative insensitivity of assays. It is also encouraging to observe improvements in rodent control, decontamination and vaccination. Recent articles in Egg Industry have concentrated on the benefits of SE free flocks to producers, the food marketing industry and consumers. It is apparent that positive publicity generated by the AEB and the UEP and the absence of large-scale recalls have restored public confidence.
In retrospect, had the industry adopted a voluntary assay and vaccination program modeled on the best of the current FDA Final Rule and available knowledge we may well have averted the August 2010 catastrophe. That is unfortunately water under the bridge but is a valuable but expensive lesson for the future.
Given the level of intensity and frequency of inspections carried out by the FDA and contract states, the industry should not lapse into a complacent mode but will maintain programs that will contribute to egg safety. We have a collective responsibility to ensure the safety of our product. Producers cannot play FDA-roulette in the hope that infections are not detected by either the insensitive environmental sampling which we carry out or worse still by traceback. The Shell Egg Industry in cooperation with the FDA should have a goal of eradicating SE from commercial flocks within five years.
We need to corporate as an industry and we need to continue to make progress. Our collective responsibility to our stakeholders requires nothing less than diligence, realism and honesty.