The February 18th edition of United Voices, the communications medium of United Egg Producers incorporates a projection of the costs associated with diversion of eggs during the cycle of four successive tests of 1,000 eggs at two-week intervals. The UEP estimates a cost of $70,000 for a 100,000 hen flock with diversion of eggs to pasteurization during the mandated period during which sampling using conventional microbiology is carried out. (A separate Egg Industry report in describes the procedure which might be followed by a producer with a suspect flock based on an environmental positive SE isolate.) This approach loosely termed “FDA Roulette” might reduce the cost of diversion but would involve greater risk of potentially infecting consumers and increase vulnerability to lawsuits.
The UEP calculation is based on a flock of 100,000 hens. This is in effect only one house in an in-line, high-rise complex with up to one million hens. From an epidemiologic perspective, identifying a truly positive flock, based on environment sampling presumes adjacent flocks may be infected. There is an opinion prevailing among poultry health professional that SE infection must involve an entire complex and not simply an isolated house. Accordingly the potential loss associated with an environmental SE, especially if FDA inspectors require additional sampling of adjacent houses, may exceed the UEP figure by a factor of ten.
The duration of the sequence of four sequential egg tests which may extend beyond the stated eight weeks, under practical conditions, could be markedly reduced by applying PCR technology as used in the EU and which has been successfully demonstrated in the U.S. Based on scientific data and economic realities the FDA would be well advised to delay implementation of the “Final Rule” until the question of diversion and acceptance of PCR is resolved. The FDA is patently unprepared to administer the program and those responsible have evidently not considered the implications of rules which were developed and justifiably shelved during a previous administration. The FDA declined to publish their “Guidance Document” as promised during January 2010. This is attributed to realizations of inadequacy raised by legitimate questions at public information sessions.
The FDA approach to this mandate is a confirmation of the extent of their lack of appreciation of the realities of SE epidemiology, current diagnostic procedures and the financial impact of their irresponsible and ill-timed rulemaking.