A public hearing on the 2009 Egg Safety Final Rule was held in Atlanta on November 5. Drs. Eric Gingrich and Paul Patterson circulated a review of the proceedings to the membership of the American Veterinarians in Egg Production who will be directly involved in advising clients, their companies and implementation of procedures.
It is apparent that most details concerning the program will be incorporated in a draft “Guidance for Industry” document which is scheduled to be published in December 2009 followed by a 60-day comment period.
From a review of the answers to questions raised, it is apparent that the FDA has obviously not thought through the proposal in detail. This is due in part to non-familiarity with practices in the industry and rotation of personnel. The FDA has an inherent bureaucratic disinclination to communicate with professionals who would have been able to advise on proposed regulations through the prolonged period of incubation of the Rule. In essence the FDA is years behind the reality of SE epidemiology in consumers and the current reality of limited infection in egg-producing flocks. Steps taken by producers individually and in compliance with Egg Quality Assurance Programs include vaccination and maintaining a cold chain. These have reduced the incidence rate of egg-borne SE to low levels relative to other vehicles of infection including poultry meat and produce.
Attendees raised a number of significant issues for which the FDA had no answer. These include the use of PCR testing as an alternative to the conventional mandated microbiological (BAM) procedures. Modern immuno-based tests and PCR assays offer a rapid diagnosis with high sensitivity and specificity and should have been incorporated into the Final Rule.
- There were no details on the scope and guidelines for proposed FDA inspections.
- The FDA has apparently not considered the NPIP 60-hen organ testing procedure relating to a determination of whether flocks are or are not infected with SE. The 60-bird sample could supplant the proposed procedure requiring a pool of 1000 eggs to be tested for four consecutive sampling periods at two week intervals.
- There is no determination as yet that producers would be obliged to recall eggs if an egg pool test is positive.
- The FDA has not considered how the 45F refrigeration requirement during transport will be implemented.
- The FDA has no appreciation of the disruption which will be caused in the event of either false positive or truly positive SE flocks. The capacity of existing breaking plants, hard cooked peeled egg facilities and both logistic and financial implications to both producers and consumers have apparently been ignored or have not been appreciated by the framers of the Rule.
- The responsibility for sampling and registering has not been defined.
- The status of the Reportable Food Registry operated by FDA is unclear with respect to environmental and egg pool testing and possible recalls.
Issues raised by attendees appear to be "novel" considerations for FDA. Storage of eggs at 45F instead of the current 55F before grading will involve considerable modification of coolers and refrigeration installations. A prominent Midwest producer estimates expenditures in excess of $750,000 to comply with this requirement. Apparently the FDA will determine the effectiveness of the 2009 Egg Safety Rule by epidemiologic surveillance involving proven egg-borne outbreaks of SE among consumers.
To this observer it appears the FDA is responding in 2010 to a problem which emerged in the mid-1980s and the FDA has blindly pursued a Rule to correct a problem which has since been largely resolved. We are now faced with ill-conceived restraints and regulations which will increase costs without a clearly defined benefit to either the industry or consumers.