"The Food Safety and Inspection Service (FSIS) welcomes the comments of the Office of Inspector General (OIG) regarding FSIS' response to the outbreak of Listeria monocytogenes (LM) in the Northeast U.S. almost two years ago (September, 2002). More than 50 FSIS investigators and scientists, working with the Centers for Disease Control and Prevention, investigated more than 10 processing facilities and FSIS analyzed more than 1,000 product and environmental samples to find the cause of the outbreak. The strain of the pathogen defined by CDC was eventually located at a Pilgrim's Pride Corporation facility in Pennsylvania and at Jack Lambersky Poultry Products, Inc. in New Jersey. None of the other 2002 LM recalls reviewed by OIG were associated with the outbreak strain.

"This unprecedented epidemiological investigation conducted by CDC and FSIS can be considered a model for inter-agency cooperation. As a result, this very difficult case was resolved efficiently and in as rapid a manner as possible.

"To address issues identified by the FSIS/CDC investigation at Jack Lambersky Poultry Products, FSIS took immediate and positive corrective action. As a result, FSIS issued a Notice of Intended Enforcement (NOIE), and required the company to submit a detailed plan of corrective action. The company reassessed its Sanitation Standard Operating Procedures and HACCP plans, installed a post pasteurization process for its fully cooked ready-to-eat items and is conducting an ongoing Listeria sampling program for environmental and finished product.

"FSIS has focused extensively during the past two years on strengthening supervisory oversight of in-plant inspection personnel. The In-plant Performance System (IPPS) is in place and circuit supervisors have clear standards and expectations for discussion with in-plant inspection personnel during their on-site visits.

"The Consumer Safety Officers (CSIs) currently assigned at Jack Lambersky have attended the innovative Food Safety Regulatory Essentials (FSRE) training. In addition, all CSIs, including relief inspectors within the Philadelphia District, have been, or are scheduled to attend FSRE training. FSRE training stresses the understanding of HACCP concepts along with production and handling of ready-to-eat (RTE) fully cooked product.

"Following the development and publication of a risk assessment for LM in ready-to-eat 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 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 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.

"Intensive Agency regulatory efforts carried out prior to the publication of Listeria rule also had a significant positive impact on minimizing food contamination. From 2002 to 2003, the number of recalls due to LM dropped from 40 to 14 and the amount of product recalled due to LM fell from 32.5 million pounds to 55,200 pounds.

"In addition, FSIS has taken action to improve the effectiveness of recalls to ensure to the greatest extent possible and that potentially contaminated products are removed from commerce and consumers receive information more quickly. 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 adverse health consequences, and in cases where products have been distributed to 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 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 in these areas to ensure that these new initiatives remain effective over time.

"FSIS looks forward to working with OIG in the future 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."