FDA Salmonella enteritidis regulations finalized

The proposed FDA regulations to reduce the incidence rate of egg-borne Salmonella enteritidis infection among U.S. consumers have now been finalized after many years of drafting, consultation and comment. Dr. Margaret Hamburg, newly appointed as commissioner of the FDA, considers that "the action will prevent thousands of serious illnesses from salmonella in eggs."
Ironically, the regulations, which will require compliance within 12 months for units in excess of 50,000 hens, are largely redundant in the context of current procedures applied by the industry to detect and suppress SE. The USDA projection of 79,000 cases of egg borne SE is speculative and may well be based on extrapolation from questionable epidemiologic data. During the protracted "gestation" of the regulations, the industry has moved forward with egg quality assurance programs, including the UEP Five Star initiative.
All commercial producers follow NPIP procedures in relation to sourcing chicks and monitoring for SE. Rodent control programs have been upgraded on virtually all commercial farms, although problems still exist with high-rise units and with biosecurity in general. The industry has adopted vaccination as a preventive measure to reduce the risk of intestinal colonization and vertical transmission. Maintaining a cold chain from the time of packing through to the point of sale has been the most significant measure in reducing incidence rates of SE. This modality coupled with greater use of pasteurized product for food service and institutional markets and improved education on handling eggs have minimized the risks of transmitting SE through eggs.
The most important addition to the monitoring program mandated by the FDA regulations comprises a mid-cycle assay which is regarded as a significant improvement in detection of infected flocks. The previous approach of monitoring flocks at transfer and then at depletion left an extended period during which flocks might become infected and pass SE through eggs to consumers by the vertical route. One contentious but epidemiologically justifiable requirement is that eggs should be refrigerated at 45 F during storage and transportation "no later than 36 hours after the eggs are laid."
This does not represent any problem for in-line units where daily transfer from houses through packing and refrigerated storage is routine. The problem does arise with off-line units, especially cage-free and organic farms which contract to packers and producers. Eggs are stored in cool rooms at temperature ranging from 50 F to 60 F with collection frequencies of 5 to 7 days. Upgrading farm coolers and ensuring that transport vehicles have functional refrigeration modules will be required in a number of cases, which is to the benefit of consumers and ultimately the image of the industry.
A number of issues must still be resolved including the possible application of PCR technology to detect SE as an alternative to conventional enrichment and culture microbiology. The relative sensitivity and specificity of the two procedures has yet to be accepted by the FDA for environmental samples and egg pools. PCR offers possible benefits for screening flocks with respect to enhanced sensitivity of detection, increased specificity which reduces false positives and expediting results.