20.04.2013

With permission from Dr Simon M. Shane: Egg-cite.com

Ms. Nicole Clausen of the FDA provided an update on progress in implementing the Egg Safety Rule at the 2013 Egg Industry Forum held in Saint Louis April 16th-17th.
During the period January through September 31st 2012 (nine-month period), the FDA carried out 64 new inspections and 31 follow-up inspections.  The latter were motivated by Voluntary Action or Required Action letters.  Of the 187 drag samples collected during inspections, seven yielded SE.
During the nine-month period, 48 No Action inspections were recorded. There were 35 Voluntary Action and 18 Required Action inspections.  There were 36 FDA Form 483s issued and 17 warning letters.  There were neither injunctions nor seizures during the period under review. 

Ms. Clausen reviewed the major reasons leading to a Form 483 report.  These included:-
• Failure to test pullets for SE before transfer to laying facilities
• Operating farms without a requisite or a deficient Salmonella Prevention Program.  In this context Ms. Clausen stressed that it is necessary to have an individual plan for each farm irrespective of common ownership of similarity of facilities.
• Failure to follow the written prevention program
• Inappropriate sampling procedures or frequency of testing
• Failure to maintain appropriate records relating to SE sampling, rodent and fly control.
During the nine-month period, all producers with environmental positive results responded by retesting egg pools and diverting eggs until the status of the flock was determined.
With respect to small-scale producers ranging in size from 3,000 to 50,000 hens, 800 farms have been registered with 300 inspections scheduled for 2013.  Contracts have been awarded to eight states (AR, CA, GA, IN, NO, OH, NY, and NC.)  All state activity will comprise targeted inspections.  If any major deficiencies are noted by State personnel, the FDA will be advised and might conduct follow-up investigations including comprehensive inspections including sampling.
It was clearly stated that farms will be exempt from the Food Safety Modernization Act (FSMA).  This will include processing plants if operated in-line.  If eggs are introduced into a packing plant from a farm or facility under different ownership, the plant will have to be registered and conform to the requirements of the FSMA.
In answer to questions the following information was shared with the attendees:-
• With respect to inspection frequency, the FDA may conduct a second inspection of a farm within 6 months to a year if major deficiencies are noted on the initial inspection.
• Two flocks within a single building divided by a wall and with their own entrances will be regarded as separate for the purpose of identification, inspection and sampling.
• The FDA is currently defining the time periods incorporated in the Egg Safety Rule including the terms “week” and “two weeks”.
• In the event of a problem arising from documenting a missing sample due to clerical error or omission, it was suggested that producers submit all relevant results with an explanation in mitigation.
• The FDA is not actively investigating farms for the presence of Salmonella Heidelberg (SH).  If there is a trace back, an investigation will be performed and the Agency will regard the SH isolate in the same light as SE. ( It is considered essential that farm managers do not document SH or any other non-Group D Salmonella isolate as this raises regulatory and legal issues).