|Congressional and Public Affairs
"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
"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."