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on September 17, 2010

FDA ‘discovers’ SE vaccination

Agency’s efforts after egg recall are too little, too late

Critics of the FDA Final Rule highlighted the failure of the agency to make provision for vaccination as an appropriate preventive measure in reducing the possibility of vertical transmission of SE from flocks to consumers.

Following the recent recall of eggs, and resulting publicity, an official of the FDA circulated an e-mail among his non-veterinarian contacts requesting information on the efficacy of SE vaccines. The e-mail incorporated a list of SE vaccines available in the U.S. and in the EU. It was significant that this list omitted a U.S. vaccine which is widely used and was developed specially to suppress SE colonization of the intestinal tract of pullets.

The effectiveness of SE vaccine has been widely recognized and the results of the PEQAP surveys in 2006 and 2008 have been available in the literature, in the reports from industry and professional meetings and information from a number of sources including veterinarians specializing in egg production.

This recent interest in vaccination by the FDA confirms all that is wrong with the agency in its approach to prevention of SE. They have developed a Final Rule based on 1980s technology, omitting the use of the PCR assay which is rapid, highly sensitive and can be used to process large numbers of specimens. The agency totally ignored the advice and counsel of their colleagues at the USDA-APHIS, failed to discuss microbiological procedures with university and state diagnostic personnel and neglected to harmonize their regulations with long-established NPIP procedures.

Press releases since the product recall from flocks in Wright County have been fragmentary but would suggest that the approach to monitoring has involved a shotgun approach. Some of the statements and published inspection reports suggest a total unfamiliarity with accepted practices in the industry. It is inexplicable that officials can regard “a change of clothing and footwear” between adjacent houses in a ten-unit in-line complex as being required or beneficial.

Recommendations concerning rodent control including exclusion and baiting, cleanliness in feed mills and the application of sound biosecurity have been adopted by the egg industry. Although lapses may occur it is noted that 97% of the nation’s egg production is not involved in the recall. To create a situation through reports which vilifies the entire industry is unfair. It is acknowledged that the alleged deviations from industry practice were associated with a company with an appalling record of disregarding environmental, immigration, labor, and safety regulations. The company was not a participant in an effective program of monitoring such as in California or Pennsylvania. The alleged deficiencies in biosecurity and the failure to test and vaccinate flocks, if substantiated, represents a callous disregard for consumers and other producers attempting to maintain acceptable standards.

It would be best if the FDA could refrain from issuing reports until a comprehensive understanding of the epidemiology of SE in the affected complexes is finalized. In the same way that mice amplify SE so the media distorts and publicizes the alleged misdeeds and deficiencies occurring on the affected farm with the implication that this is common to the entire industry.

If the FDA sincerely wishes to reduce the incidence rate of SE among consumers they would be well advised to take counsel from experienced avian diagnosticians and production specialists affiliated to universities, state laboratories and professional associations. This commentator has over 45 years of experience in poultry veterinary medicine having dealt early in his career with Salmonella pullorum and Salmonella gallinarum which are effectively analogs of Salmonella enteritidis. There are many poultry disease practitioners and specialists with similar and even greater experience especially those with both domestic and international exposure and involvement in primary breeding.

Initiating and circulating “tell me all about SE vaccination” e-mails is too little and too late and confirms a lack of institutional knowledge and competence within an agency, which is hard-pressed to fulfill congressional mandates without extending its reach into areas where it has no experience.  

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