"The Food Safety and Inspection Service (FSIS) welcomes the comments and the five recommendations of the Office of Inspector General's (OIG) audit of FSIS' verification activities associated with the 2002 Pilgrim's Pride recall.

"On October 12, 2002, the Pilgrim's Pride Corporation facility in Franconia, Pennsylvania, initiated a voluntary recall following the discovery by FSIS of a strain of Listeria monocytogenes (LM) determined by the Centers for Disease Control (CDC) to be responsible for an outbreak of Listeriosis in the Northeast U.S.

"In an effort to determine the cause of this outbreak, more than 50 FSIS investigators and scientists launched a joint investigation with CDC beginning in September 2002. This unprecedented epidemiological investigation conducted by CDC and FSIS was a model of inter-agency cooperation. In the course of the investigation, FSIS investigated multiple processing facilities and analyzed more than 1,000 product and environmental samples. As a result, this very difficult case was resolved efficiently and in as rapid a manner as possible. In addition to discovering the outbreak strain in environmental samples taken at the Pilgrim's Pride Corporation facility, FSIS found the strain in product sampled from Jack Lambersky Poultry Products, Inc., in New Jersey.

"The five recommendations contained in the report relate to incomplete documentation of the recall, which was closed in June 2003. FSIS has made substantial changes to its recall process, strengthened verification activities, and established clearer lines of authority to increase the possibility that contaminated products are removed from commerce and that consumers receive information promptly.

"FSIS has developed and issued revised Directive 8080.1, "Recall of Meat and Poultry Products." This directive will enhance the instructions and guidance to agency personnel responsible for verifying the effectiveness of a recall. To improve speed and efficiency, the revised directive enables the collection of product distribution information at the plant to begin prior to microbiological testing results becoming final. The Agency has also increased the number of effectiveness checks it carries out during Class I recalls, those posing the greatest potential threat to public health, in the event of illnesses or when product has been distributed to schools or at-risk populations.

"The revised directive includes timeframes for reporting verification activities within FSIS and includes provisions for locating products at point of sale and ensuring the proper disposition of recalled products. We are continuing to review this issue to determine appropriate ways to further strengthen the recall process.

"FSIS, through its Office of Program Evaluation, Enforcement and Review (PEER) will be continually monitoring progress on the new recall procedures to be sure they are effective over time.

"Following the development and publication of a risk assessment for LM in ready-to-eat (RTE) meat and poultry products, FSIS published a rule in June 2003 to further drive down the rate of LM. The rule requires all establishments that produce RTE products that are exposed to the environment after cooking to develop written programs to control LM and to verify the effectiveness of those programs through testing. The rule also encourages plants to install new technologies that eliminate or suppress the growth of LM. Establishments must share testing data and plant generated information relevant to their controls with FSIS. Plants that produce high- and medium-risk products and plants that rely on sanitation procedures alone to control LM receive the most intense Agency regulatory scrutiny.

"A recently completed survey of RTE establishments carried out by FSIS Inspectors-In-Charge revealed that establishments have responded to the rule appropriately and have strengthened and intensified their programs to control LM. Almost every establishment is testing food contact surfaces for Listeria, although plants using a process like steam pasteurization that kills LM inside a package would not be expected to test product contact surfaces, since those products would not be exposed to the environment after cooking. The percentage of plants using interventions that suppress the growth of LM has grown dramatically since the rule went into effect, as have the number of plants that are testing the processing environment and full-cooked products for Listeria.

"The new Listeria rule challenged industry to do more to eliminate LM. The survey indicates that plant testing has been greatly expanded and the use of new technologies for eliminating this pathogen is becoming widespread. The survey results help explain why we are finding fewer positive samples of Listeria monocytogenes in our regulatory testing program.

"FSIS looks forward to working with OIG as FSIS develops cost-effective and science-based policies that will improve the safety and wholesomeness of meat and poultry products enjoyed by American consumers."