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Revised Action
Plan for Control of Listeria monocytogenes for the Prevention of
Foodborne Listeriosis
National Advisory Committee on Meat
and Poultry Inspection
May 2000 Public Meeting
Issue Paper on Current Thinking
Purpose
At its May 2000 meeting, the National Advisory Committee on Meat and
Poultry Inspection (NACMPI) will be briefed on the Agency's response to
the President's May 5, 2000, directive for enhanced control of
Listeria monocytogenes and thereby prevention of foodborne
listeriosis. FSIS has identified short-term initiatives (some of which
have been completed), long-term initiatives, and additional issues for
discussion by the Committee. At the May 2000 meeting, the Committee will
be briefed on the strategy and will be asked to make recommendations on
the revised action plan as well as to surface any additional issues that
are raised during discussion.
Discussion
The revised white paper on control of Listeria monocytogenes
that was distributed for the May 15, 2000, public meeting on Listeria
monocytogenes includes more information on the topics discussed
here. (The paper and attachments will be provided to the Committee.)
Listeria monocytogenes is a foodborne pathogen of public health
concern as reflected in statistics for severe foodborne illnesses and in
national objectives for reducing foodborne illness. Each year, the
bacteria cause at least 2,493 cases of listeriosis. Of these, 2,298
persons are hospitalized and 499 persons die. The case fatality rate is
high -- 20 deaths per 100 cases. (See
Table 1.)
While the nation met its Healthy People 2000 target for reducing
foodborne listeriosis (see Table 2),
the Healthy People 2010 target is a further reduction from the 0.5 cases
per 100,000 baseline of 1997 to 0.25 cases per 100,000. (See
Table 3.) The Administration
believes that this goal can be met by 2005 if concerted actions are
taken to control Listeria monocytogenes.
Although the Agency is awaiting preliminary results from the
interagency Listeria monocytogenes risk assessment, currently
available FSIS data from recalls of meat and poultry products indicate
that Listeria monocytogenes remains the primary trigger for
product recalls. (See Table 4.)
FSIS microbiological monitoring data from 1993-99 suggest that hot dogs
and luncheon meats are two products of particular concern as vehicles
for foodborne Listeria monocytogenes. (See
Table 5.) Consequently, the
proposed action plan for control of Listeria monocytogenes
includes measures directed at further reducing the risks of foodborne
illness associated with those products.
FSIS has updated its proposed action plan for control of Listeria
monocytogenes based on discussions and recommendations of the NACMPI,
public meetings, additional data, the work of an Agency working group on
this topic, and the May 5, 2000, Presidential directive (see
Attachment). The revised Action Plan is summarized below under Immediate
or Near-Term Measures and Long-Term Measures. Measures for Further
Discussion are included in the updated white paper.
Immediate or Near-Term Measures
- Survey of industry practices: FSIS has
conducted a survey of plant actions taken in response to the 5/26/99
Federal Register notice to ensure that plant HACCP plans are
adequately addressing L. monocytogenes as a potential hazard in
ready-to-eat meat and poultry products.
A. Performance standards: FSIS intends to
publish a proposed rule to establish performance standards for
shelf-stable and perishable ready-to-eat products that will address
the need to reduce all pathogens. The Agency also intends to propose
to require that meat and poultry plants producing ready-to-eat
products conduct environmental testing for Listeria spp in
order to verify their Sanitation Standard Operating Procedures (SSOPs).
The proposed frequency would be based on the volume of product
produced by the plant. The Agency will consider public comment on
whether plants should conduct only environmental testing, finished
product testing or both types of testing.
B. Validated safe handling instructions and/or open dating:
FSIS also intends to publish a proposed rule to require that
establishments using safe handling instructions and/or open dating
(e.g., "sell by" or "use by" dates) on product labeling validate the
accuracy of the safe handling/open dating information in their HACCP
plans. The proposal will include, for public comment, proposed
criteria on the use of open dating in meat and poultry products.
- FSIS finished product testing.
The Agency
intends to modify its program for sampling and testing ready-to-eat
meat and poultry products for Listeria monocytogenes. The
revised testing programs, for regulatory verification of industry HACCP
plans, will expand the range of ready-to-eat meat and poultry products
subject to testing for the pathogen. The frequency of FSIS testing will
depend on the testing regime that the plant employs. The more the plant
is testing, the less likely it is that FSIS will test.
- Industry guidance:
In conjunction with the
proposed rule on performance standards, the Agency intends to publish
guidance to industry regarding appropriate intervention measures that
could be initiated in plants to reduce the risk of L. monocytogenes
from hot dogs and sliced luncheon meats.
- In-depth verification reviews:
On an ongoing
basis, FSIS plans to use its revised draft protocol for in-depth
verification reviews of the regulatory compliance and scientific
validity of a company's HACCP systems.
- Interagency risk assessment:
The interagency
risk assessment supported by FDA and FSIS will determine the prevalence
and extent of consumer exposure to foodborne L. monocytogenes
and assess the resulting public health impact of such exposure. The
public health impact will be described in terms of risk rankings for
the products considered. Release is tentatively scheduled for the
summer of 2000.
- Modified specifications for ready-to-eat products for USDA
commodity programs:
FSIS intends to "jump-start" the use
of instructional labeling for safe use of ready-to-eat products by
working with AMS and other USDA agencies to modify the specifications
for ready-to-eat foods purchased for USDA commodity food programs
(e.g., school breakfast and lunch and the Women, Infants and Children
Program).
- Public messages for at-risk consumers:
The
Agency will work with FDA and constituent groups to develop appropriate
public messages for susceptible populations regarding the consumption
and preparation of ready-to-eat foods that pose a significant risk from
L. monocytogenes. One key message is that ready-to-eat products
for consumption by high-risk populations should be heated.
- Consumer education:
FSIS will use the
information in the interagency risk assessment to develop a consumer
education campaign to focus on proper refrigeration temperatures and
steps to prevent temperature abuse during food preparation in the home.
This campaign will also include specific advice to heat ready-to-eat
meat and poultry products that will be consumed by high-risk
populations.
Long Term
- Research: At the request of FSIS, ARS has
designed a study to examine prevalence of L. monocytogenes
in a ready-to-eat product (hotdogs) supplied by volunteer plants over a
12-month period. Product will be held at a temperature representing
typical retail storage and at an "abuse" temperature, and will be
tested for the presence of L. monocytogenes at several
time points over a 3-month period. ARS also proposes to subtype and
enumerate bacteria in positive samples. Approximately 12 members of the
ready-to-eat manufacturing industry are participating in the study on
condition of anonymity. The product samples for research will not be
marketed.
This study will produce data that will address several important
information gaps, including the prevalence of contaminated products in
the marketplace, the effect of "grow out" on detection of Listeria
monocytogenes during shelf life, and counts of
Listeria monocytogenes that actually occur in commercially
packaged products over their shelf-lives, among others.
Questions
- The Agency would appreciate feedback from the Committee on
possible additional measures for control of Listeria
monocytogenes, including those described in the updated action plan
as well as additional measures that the Committee envisions.
- FSIS would appreciate feedback on specific types of research
that the Committee believes would be appropriate to understand the
organism and its mechanisms, in order to enable interventions to
prevent or reduce the likelihood of foodborne illness.
- FSIS would appreciate feedback from the Committee on data needs
and specific sources of data needed to support rulemaking and education
to prevent or reduce the likelihood of foodborne illness.
Contact Person
Judith Riggins, Associate Deputy Administrator
Office of Policy, Program Development and Evaluation
Food Safety and Inspection Service
(202) 720-2710
Table 1: Severe Foodborne
Illness, Annual Burden of Illness Estimates - Listeriosis
Table 2: Foodborne Infections -
Healthy People 2000 Target for Listeriosis
Table 3: Surveillance - Healthy
People 2010 Target for Listeriosis
Table 4: Number of Recalls for FY
99 by Hazard Type Table 5: Prevalence of L. monocytogenes in
Ready-to-Eat Meat/Poultry Products Tested, 1993-99
Attachment: Presidential Memorandum to the
Secretary of Agriculture and the Secretary of Health and Human Services,
May 5, 2000
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THE WHITE HOUSE
May 5, 2000
MEMORANDUM FOR
THE SECRETARY OF AGRICULTURE
THE SECRETARY OF HEALTH AND HUMAN SERVICES
SUBJECT:
REDUCING THE RISK OF LISTERIA MONOCYTOGENES
Food safety is a vital issue for all Americans. When people across
this country sit down to a meal at home or in a restaurant, they expect
that the food they eat will be safe. While the U.S. food supply is
abundant, the marketplace has evolved from one dominated by minimally
processed basic commodities for home preparation to one with an array of
highly processed products that are ready-to-eat or require minimal
preparation in the home.
To take account of the changes in the way Americans eat and to ensure
that America=s food supply
remains safe, my Administration has made wide-ranging, dramatic
improvements in food safety. We have worked successfully to
revolutionize our meat and poultry inspection system, instituting
scientific testing and pathogen reduction controls to target and reduce
dangerous pathogens like Salmonella and E. coli O157:H7
and the illnesses they cause. We also have implemented an innovative
system of preventative controls for the seafood industry, published
industry guidance to improve the safety of fruits and vegetables, and
taken steps to prevent unsafe imported foods from reaching American
consumers. My Food Safety Initiative is now in its third year of
improving food safety surveillance, outbreak response, education,
research, and inspection. In 1998, I issued an Executive Order creating
the President's
Council on Food Safety (Council), which oversees Federal food
safety research efforts and is currently developing a comprehensive,
national food safety strategic plan. It is under the Council's
auspices that my Administration produced last year an Egg Safety Action
Plan with the goal of eliminating illnesses from Salmonella
Enteritidis in eggs. Additionally, we launched a high-tech early
warning system called PulseNet that uses DNA-fingerprinting techniques
to help us better detect and prevent outbreaks of foodborne illness.
These and other efforts have helped to make meaningful improvements
in food safety. But we can do even more. Millions of Americans get sick
from eating contaminated food each year. With changing patterns of food
production and consumption, we must continue to aggressively meet the
food safety challenges of the 21st century.
One challenge we must address immediately is that of Listeria
monocytogenes, which can cause a severe infection called listeriosis.
Listeriosis is a significant public health concern, and is especially
lethal, resulting in death in about 20 percent of cases. The Centers for
Disease Control and Prevention estimate that 2,518 persons become ill
and 504 persons die each year from listeriosis. Pregnant women with
listeriosis can pass the infection on to their unborn children,
potentially resulting in severe illness or death to the fetus or newborn
infant. Others at high risk for severe disease or death are the elderly
and those with weakened immune systems. Ready-to-eat food products, such
as lunch meats, smoked fish, certain types of soft cheeses, and hot
dogs, are among the foods most commonly associated with food-related
illness from Listeria.
To address this serious public health problem, the Department of
Health and Human Services (HHS), in cooperation with the Department of
Agriculture (USDA), is conducting a risk assessment on Listeria
monocytogenes to determine which foods warrant further preventive
measures. This risk assessment will be completed shortly, and I believe
we must build on what is already being done to target this deadly
organism.
My Administration's goal --
articulated in our Healthy People 2010 plan
B is to cut the number of
illnesses caused by Listeria in half by 2010, from 0.5 cases to
0.25 cases per 100,000. To meet and exceed this goal, I hereby direct
you, in cooperation and consultation with the Council and relevant
Federal agencies, to report back to me within 120 days on the aggressive
steps you will take to significantly reduce the risk of illness and
death by Listeria monocytogenes in ready-to-eat foods. In
particular, within this time period, I direct the Secretary of
Agriculture to complete proposed regulations that include any
appropriate microbiological testing and other industry measures to: 1)
prevent cross-contamination in the processing environment; 2) ensure
that the processing of ready-to-eat products meets appropriate
standards; and 3) ensure that such products are safe throughout their
shelf life. In addition, I direct the Secretary of Health and Human
Services, within this time frame, to develop an action plan identifying
additional steps necessary to reduce Listeria monocytogenes
contamination. This plan should include consideration of control
measures for at-risk foods and the publication of guidance for
processors, retailers, and food service facilities. Finally, you should
consider whether enhanced labeling is necessary to provide additional
safeguards for consumers. These actions should be based in science and
should establish the foundation for a comprehensive approach that
significantly reduces the opportunity for Listeria product
contamination and Listeria-related illnesses to occur. All these
actions, taken together, should allow us to achieve our Healthy People
Goal by 2005 rather than 2010.
These steps will continue to ensure the safety of America=s
food supply and will help protect some of the Nation's
most vulnerable populations from foodborne illness.
WILLIAM J. CLINTON
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