Significant issues were raised during a recent presentation in Atlanta regarding introduction and implementation of the FDA Egg Safety Final Rule without satisfactory assurances that the program would be implemented equitably, impartially and without disruption.
The important areas which were reviewed at the meeting organized by the UEP included:
- SE prevention plan
- Every farm must have a written Salmonella enteritidis (SE) prevention plan specifying supervisory personnel and noting biosecurity procedures, surveillance protocols and recorded results
- Environmental sampling and detection of SE
- Procedures to conduct an environmental assay using drag swabs over accumulated manure in pits, egg belts, manure belts, fan blades and floor litter were described. It is essential that standard procedures should be followed since improper technique may result in false positive results due to cross contamination. The accurate labeling of specimens is critical since in the event of a positive result there should be no question as to the flock or farm involved.
- A list of approved laboratories to assay drag swabs and egg pools was provided together with the cost of assays
- Age of sample flocks
- FDA guidance designates testing to be carried out at 14 to 16 weeks of age or approximately two weeks before transfer to laying houses if the conventional 17 week industry placement practice is followed.
- The second sample is required between 40 to 45 of age and
- If flocks are molted, between 4 to 6 weeks after commencement of production in the second cycle
- It is prudent practice to assay chick box papers and to determine the SE status of a flock two weeks prior to depletion
- Procedures in the event of a presumptive positive environmental test
- Details regarding sampling of egg pools (“FDA roulette”) are specified. It is noted that this is the most contentious component of the entire program. If any of the egg pools are positive then all eggs from the confirmed positive flock released to the market have to be recalled and an appropriate report is required in the computerized FDA database.
- If producers do not wish to market shell eggs from the presumptive positive flock for the duration of the testing period, as recommended by UEP, eggs must be diverted to breaking and pasteurization with the producer bearing the loss.
- It is noted that application of PCR assay would expedite the entire process and would be both superior in terms of sensitivity and specificity in detecting SE in egg pools.
- Registration requirements
- Shell egg producers holding more than 3,000 laying hens on a specific farm must register with the FDA using the prescribed procedure
- Disinfection following a positive SE assay
- After depletion of a flock proven to be infected with SE, appropriate cleaning of housing and equipment followed by disinfection is required
- Eggs must be held and transported at a temperature of 45 F commencing 36 hours after they have been laid. This should not be a problem for in-line units but will create difficulties for off-line operations, especially if eggs are transported over extended distances.
It is anticipated that the FDA will issue a guidance document for the egg industry following the format of the comprehensive Small Entity Compliance Guide dated April 2010. This document can be used as a boiler plate to develop farm procedures.
Farm inspections are regarded as a potentially confrontational component of the FDA Egg Safety Final Rule. Some parallels can be derived from introduction of the USDA-FSIS, HACCP System in red meat and poultry plants in the 1990s. The industry at that time was in effect ahead of regulators with respect to understanding and implementing HACCP. Since industry took the initiative, there were few problems with regard to administration of the system by relatively inexperienced and untrained and occasionally over-zealous inspectors. In the case of the FDA Egg Safety Final Rule it is acknowledged that the agency has little or no experience on farms and has apparently delayed training inspectors. Their programs have allegedly been developed with minimal communication and interaction with the U.S. egg industry.
The FDA intends to impose two types of inspections. The first will be conducted as a routine to assess compliance with the Regulation. Risk-Informed inspections will be more comprehensive and will follow either a traceback or evidence of non-compliance. Key areas which may result in a Risk-Informed inspection include failure to implement a written SE-prevention plan, failure to purchase SE-monitored pullets, neglect of the farm’s biosecurity, rodent control or cleaning program and failure to maintain a designated surveillance/monitoring program with relevant records.
The UEP has functioned as the representative of the industry in attempting to interface with the FDA. As an observer of the process it is apparent that the FDA has embarked on the Egg Safety Final Rule without a thorough appreciation of the realities of commercial egg production and certainly with untrained personnel and limited resources. In the light of the low incidence rate of egg-borne salmonellosis since the mid 1990s, the initiative appears to have a basis in politics rather than as a necessary public health measure.
Given the rising incidence rate of paratyphoid salmonellosis associated with spices, produce and contaminated surface water, introduction of the Final Rule in July 2010 is somewhat reminiscent of returning the bolted horse to its stable after recapture and then carefully shutting the door. The regulations as framed display a lack of appreciation of modern technology including PCR assay, failure to appreciate the extent of effective vaccination of flocks over a decade and disregard of the effect of a 20-year adherence to EQAP programs.
The Egg Safety Final Rule reflects a 1980s approach which allocates apparently limited resources to the resolution of a non-problem. With all the problems of the environment, the economy, health and poverty the U.S. government seems more concerned with implementing a cosmetic program rather than devising a broad and effective approach to suppress food-borne diseases based on risk analysis and application of modern technology. Can the public anticipate a return in the form of improved health from the considerable expenditure of money and effort on the part of the industry and the overstretched regulatory agency involved?