on February 23, 2010
FDA Egg Safety Final Rule slated for July
Is the time between rule adoption and implementation too short?
Highlights of various presentations and discussions include:
The FDA has not published the promised January 2010 Guidance Document which will serve as a commentary on the Final Rule which will take effect in July 2010 for flocks in excess of 50,000 hens. Nancy Bufano of the FDA/CFSAN was unable to address many issues or to provide specific information on FDA policy regarding the Final Rule. She reported that the agency would publish two guidance documents "within the next several months." A glance at the 2010 calendar will confirm the short period between the release of the long promised "Guidance Document" and the date for implementation.
Under the circumstances should the FDA not bow to the inevitable and put back the intended mid-year commencement of their oversight by at least the duration of their delay? Attempting to implement impractical requirements, which have been pointed out by industry specialists in public hearings, will result in disruption in production, litigation, erosion of consumer confidence and embarrassment for the agency.
- It will be incumbent for producers to report only egg-positive results to the FDA Reportable Food Registry. Environmental positive isolations are not reportable.
- The Food Safety Enhancement Act of 2009 empowers the FDA to mandate recalls of eggs from flocks with confirmed isolation from egg pools, denoting vertical transmission of SE. In terms of the Final Rule the most prudent approach would be to withhold all eggs after a positive environmental sample until the required numbers of consecutive egg pools have been examined. This would result in considerable loss from diversion to breaking—if in fact this expedient is possible.
- Applying conventional microbiology and taking into account the delays involved in collection, transport and processing of eggs the ten-day stipulated period is unrealistic and may in practice extend to fourteen days. This means that producers would be diverting eggs to breaking until absolute confirmation of a negative status. If however producers wish to market eggs, in anticipation of a negative result, they will be free to do so in accordance with FDA regulations. Demonstrating SE in an egg pool would however result in a mandatory recall of all eggs produced from the time of collection of the batch yielding a positive result. The FDA has effectively created the exciting sport of "Egg Roulette."
- Expediting the examination of egg pools would resolve many of the problems imposed by introduction of an impractical program which will contribute little to the health of consumers. Dr. Shelly Rankin of the University of Pennsylvania reported on a PCR assay procedure which can provide a result within 48 hours under practical conditions with both high sensitivity and corresponding specificity. This procedure will detect SE in both manure drag swabs and egg pools. Approval of the PCR procedure by the FDA is critical to adoption of the Final Rule.
This procedure has been used as a diagnostic test by the Turlock Branch Laboratory of the CDELS in California for years. PCR would reduce the high cost associated with obsolete conventional microbiology as currently mandated by the FDA.
- FDA intends to conduct 100 farm visits per year to inspect facilities, management and records and will contract with state departments of agriculture to visit all other facilities. It is comforting to learn that "inspectors" most of whom have never seen an egg outside a supermarket, will be trained during April and May for a July start-up.
- It is accepted that a combination of modalities will be required for an effective SE reduction program. Components will include biosecurity, diligent suppression of rodents, effective application of both live attenuated ST and inactivated SE emulsion vaccines coupled with a cold chain extending from production through to point of sale. Complete eradication of SE in the U.S. egg industry is a long term issue and will involve the cooperation of the NPIP, primary breeders, supply flocks and hatcheries, the commercial industry, the FDA and in the opinion of a few beltway insiders, a new Food Safety Agency.
- Data from the Pennsylvania EQAP has demonstrated a marked reduction in recovery of SE from eggs and manure from 1992 through 2009. Most recent figures show an egg-pool recovery rate of 0.005% with 3.2% from environmental drag swabs. Over 80% of Pennsylvania producers now participate in the program.