FSIS Rule Designed to Reduce Listeria monocytogenes in Ready-to-Eat Meat & Poultry
The U.S. Department of Agriculture's Food Safety and Inspection
Service is issuing an interim final rule requiring that federal
establishments producing certain ready-to-eat (RTE) meat and poultry
products take meaningful steps to further reduce the incidence of
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New Listeria Procedures
FSIS designed the regulations to encourage establishments to employ
more effective Listeria control measures. All establishments
that produce RTE products that are exposed to the environment after
lethality treatments will be required to develop written programs, such
as Hazard Analysis and Critical Control Point (HACCP) systems, Sanitation
Standard Operating Procedures (Sanitation SOPs) or other prerequisite
programs, to control L. monocytogenes.
Establishments must also verify the effectiveness of these actions
through testing and sharing the results with FSIS. To ensure that
establishments effectively control this pathogen, FSIS will conduct
its own verification activities for each establishment’s
Listeria control program.
Establishments will also be required to share data and information
relevant to their Listeria controls with FSIS.
Establishments will be required to furnish information on
the production volume and related information of products
affected by the regulations. This information is critical for
FSIS to design a more risk-based verification-testing program.
In particular, FSIS will increase verification in operations that
produce large volumes of product because there is the potential
for a greater number of people to be exposed to this pathogen if
Under these regulations establishments are encouraged to make food
safety enhancement claims on their RTE product labels that describe
the processes used to eliminate or reduce Listeria monocytogenes,
or suppress its growth in products. FSIS believes this option gives
companies an opportunity to inform consumers, particularly pregnant
women and other vulnerable segments of the population, about the extra
steps companies have taken to enhance the safety of their products with
regard to L. monocytogenes.
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The rule mandates that establishments incorporate one of three strategies
to control L. monocytogenes. Most of FSIS’ verification
activities will be concentrated in those establishments that rely solely
on sanitation for preventing Listeria contamination and in which
there is no limitation on the growth of the pathogen if present in the
product. This way, establishments will be encouraged to select the most
effective strategies to control for Listeria.
The alternatives that establishments will have to select from are:
- Alternative 1 – Employ both a post-lethality treatment and a growth inhibitor for Listeria on RTE products. Establishments opting for this alternative will be subject to FSIS verification activity that focuses on the post-lethality treatment effectiveness. Sanitation is important but is built into the degree of lethality necessary for safety as delivered by the post-lethality treatment.
- Alternative 2 – Employ either a post-lethality treatment or a growth inhibitor for Listeria on RTE products. Establishments opting for this alternative will be subject to more frequent FSIS verification activity than for Alternative 1.
- Alternative 3 – Employ sanitation measures only. Establishments opting for this alternative will be targeted with the most frequent level of FSIS verification activity. Within this alternative, FSIS will place increased scrutiny on operations that produce hotdogs and deli meats. In a 2001 risk ranking, FSIS and the Food and Drug Administration identified these products as posing relative high-risk for illness and death.
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Listeriosis & Listeria monocytogenes
Consumption of food contaminated with L. monocytogenes can
cause listeriosis. Listeriosis is a potentially fatal disease in
newborns, the elderly and persons with weakened immune systems, such
as those with chronic disease or human immunodeficiency virus (HIV)
infection or those taking chemotherapy for cancer. Listeriosis is also
a major concern in pregnant women. Even though symptoms may be
relatively mild in the mother, the illness can be transmitted to the
fetus, causing illness or fetal death.
According to the Centers for Disease Control and Prevention (CDC), the
rate of listeriosis has fallen by 35 percent from 1996-2002. Still,
each year, L. monocytogenes causes an estimated 2,493 cases
of listeriosis and 499 deaths. The case-fatality rate is high across
the whole population – 20 deaths per 100 cases of illness.
Epidemiologic surveillance data show that the case-fatality rate varies
by age, with a higher case-fatality rate among newborns and the
L. monocytogenes is a pathogenic bacterium found in the
environment (e.g., in soil, water, vegetation and on the surfaces
of equipment, floors and walls) and is often carried by healthy
animals (including humans). L. monocytogenes is spread
very easily by direct food contact with a contaminated surface,
and it can survive and grow in a refrigerated, packaged RTE product.
L. monocytogenes grows under low-oxygen conditions and at
low refrigeration temperatures and survives for long periods of time
in the environment, on foods, in processing plants and in household
refrigerators. Although frequently present in raw foods of both
plant and animal origin, it also can be present in cooked foods
because of post-processing contamination.
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Listeria In Ready-To-Eat Products
RTE product is adulterated if it contains L. monocytogenes
or if it comes into direct contact with a food contact surface that
is contaminated with L. monocytogenes. Listeria can
contaminate and grow in RTE products if they are not formulated or
produced in a manner to destroy or suppress the growth of the organism.
A number of factors can cause or contribute to L. monocytogenes
contamination of RTE meat and poultry products in a meat or poultry
First, if the pathogen is already present in product ingredients, a
processing error, such as incorrect formulation or inadequate processing
time or temperature, can result in the production of products containing
Second, a product that has undergone a successful lethality treatment
can be contaminated by biofilms on food-contact surfaces of equipment
used for processing, handling, or packaging the product. The product
can also be exposed to environmental contamination or cross-contamination
in the post-lethality processing environment. One cause of
cross-contamination can be plant construction in the post-lethality
area of the establishment, unless precautions are taken to protect
the products during the period of construction. Serious outbreaks
of listeriosis have occurred because of the failure to take such
precautions during facilities construction or remodeling.
Additional causes of contamination or cross contamination can be poor
facilities design or plant equipment layout. Cross-contamination can
occur if the flow paths of raw product and finished products cross
or if vehicle or personnel traffic from outside the plant or from a
raw-product area of the plant enters an area where exposed finished
products are handled. Contamination or cross-contamination also can
occur if processing equipment has not been designed for easy
cleaning, or if equipment or facilities have hard-to-reach niches
that can harbor L. monocytogenes or other pathogens.
Under this rule, establishments will be required to develop effective
ways of controlling Listeria in RTE products and in the
establishment. FSIS will verify the effectiveness of these control
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During the 1980’s, L. monocytogenes began to emerge as
a problem in processed meat and poultry products. In the 1990’s,
state health departments and the CDC investigated an outbreak of
foodborne illness in which hotdogs, and possibly deli (luncheon)
meats, were implicated. CDC and FSIS investigators isolated the
outbreak strain, a strain of L. monocytogenes, from an opened and
previously unopened package of hotdogs manufactured by a single plant.
DC eventually reported 101 illnesses, 15 adult deaths, and 6
stillbirths or miscarriages associated with the outbreak. By1999 an
especially virulent strain of L. monocytogenes emerged. The
Agency concluded that many establishments should reassess their HACCP
plans and FSIS published a notice advising manufacturers of RTE meat
and poultry products of the need to reassess their HACCP plans to
ensure that the plans were, in fact, adequately addressing L.
Data gathered during an outbreak of Listeria related illnesses
during the summer of 2002, combined with other food safety investigations
and in-depth verification reviews, led FSIS to conclude that some
establishments were not adequately addressing the potential for
bacterial contamination in their Hazard Analysis and Critical Control
Points (HACCP) plans, Sanitation Standard Operating Procedures
(Sanitation SOP), or other control measures.
In December 2002, FSIS implemented a directive outlining additional
steps to be taken by USDA inspectors to ensure that establishments
producing RTE meat and poultry products are preventing
L. monocytogenes contamination. Under this directive,
plants producing deli meats and hotdogs without validated
Listeria programs to eliminate L. monocytogenes
on the product, on food contact surfaces, and in the environment,
were subject to an intensified FSIS testing program. This
intensified program includes increased product and food contact
surface testing, environmental testing in the plant, and increased
reviews of plant records and data.
In February 2003, FSIS released a draft risk assessment on
Listeria in RTE meat and poultry products. A public
meeting was held on February 26, 2003 to discuss the results.
The risk assessment, in conjunction with a previously released
FDA/FSIS risk ranking and public comment gathered on the topic,
provided important data enabling FSIS to design a final
L. monocytogenes rule.
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