"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
"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