|
FDA/Center for Food Safety and Applied Nutrition
USDA/Food Safety and Inspection Service
Centers for Disease Control and Prevention
January 2001
|
|
|
Reducing the Risk of Listeria monocytogenes
Joint Response to the President
EXECUTIVE SUMMARY
Listeria monocytogenes (LM), a harmful bacterium that can be found in a variety of foods, causes an estimated
2,500 illnesses and 500 deaths in the United States each year. In pregnant women, LM-caused illness can result in
miscarriage, fetal death, or severe illness in or death of a newborn infant. The elderly and those with weakened
immune systems are also at risk for severe illness or death from LM-contaminated food.
In response to the President's May 5, 2000, directive to reduce LM-related disease by 50 percent by the year 2005,
the Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) have reviewed
ongoing LM prevention and control activities and have developed a joint action plan, which includes immediate, short-term,
and long-term activities targeted at the serious problem of LM-caused illness.
For more than 15 years, HHS and USDA have been working toward preventing LM illness and controlling this pathogen.
In recent months, the two agencies conducted a risk assessment of LM in order to better understand both the health risk
posed by the bacterium and the associated food vehicles that can transmit the pathogen. Results from this risk assessment
support the need for additional public health action.
The joint plan complements the work of the President's Council on Food Safety, focusing on certain
ready-to-eat foods that can potentially become contaminated with LM and support the pathogen's
growth, and that are intended to be eaten as purchased (without additional preparation by the consumer
such as cooking, which can kill the bacterium). This joint plan is responsive to the President's call for
aggressive steps to significantly reduce the risk of illness and death caused by Listeria monocytogenes
in ready-to-eat foods, and consideration of control measures for at-risk foods.
HHS and USDA have identified eight areas for Action:
- Enhance consumer and health care provider information and education efforts.
- Develop and revise guidance for processors, retailers, and food service/institutional establishments
that manufacture or prepare ready-to-eat foods.
- Develop and deliver training/technical assistance for industry and food safety regulatory employees.
- Review and redirect enforcement and regulatory strategies including microbial product sampling.
- Propose new regulations and revisions to existing regulations, as needed.
- Enhance disease surveillance and outbreak response.
- Initiate projects with retail operations such as delicatessens and salad bars to pilot LM control
measures including employee practices.
- Coordinate research activities to refine the risk assessment, enhance preventive controls, and
support regulatory, enforcement and educational activities.
The attached report provides further detail on the action items. In addition, the following table
summarizes the timeframes within which HHS and USDA plan to complete the action items.
HHS and USDA Action Areas |
Implementation Timeline |
Short-term Initiate or complete in CY 2001 |
Long-term Complete by end of CY 2004 |
1. Enhance Consumer & Health Care Provider Information & Education Efforts. |
X |
|
2. Develop & Revise Guidance for Processors, Retailers, & Food Service/Institutional
Establishments: |
- Develop / Update Processor Guidance |
X |
|
- Revise Retail Guidance (Food Code) |
X |
|
3. Develop & Deliver Training / Technical Assistance to the Regulated Industry & to Food
Safety Regulatory Employees:
|
- Outreach to small & very small businesses |
X |
|
- Utilize existing cooperative mechanisms |
X |
X |
- Long Distance Training, e.g. satellite-and computer-based training |
X |
X |
4. Review & Redirect Enforcement & Regulatory Strategies Including Microbial Product
Sampling:
|
- Redirect inspections & surveillance sampling & LM testing |
X |
X |
- Improve analytical methodology |
X |
|
- Place greater emphasis on ready-to-eat products |
X |
|
- Emphasize industry validation measures to prevent & control LM |
X |
|
5. Propose New Regulations & Revisions to Existing Regulations as needed. |
X |
X |
6. Enhance Disease Surveillance and Outbreak Response:
|
|
X |
X |
|
X |
X |
- Public Health Monitoring |
X |
X |
7. Initiate Projects with Retail Operations such as Delicatessens & Salad Bars to Pilot
LM Control Measures including Employee Practices. |
X |
X |
8. Coordinate Research Activities to Refine the Risk Assessment, Enhance Preventive
Controls, & Support Regulatory, Enforcement, & Educational Activities. |
X |
X |
Joint Response to the President:
Reducing the Risk of Listeria monocytogenes
U.S. Department of Agriculture and Department of Health and Human Services
January 2001
I. Background
American consumers enjoy one of the safest food supplies in the world. Nevertheless, each year
millions of Americans become ill, some with potentially fatal illnesses, from eating contaminated
food. To address this serious public health problem, the Clinton Administration has repeatedly
taken leadership action to enhance the safety of the U.S. food supply and reduce foodborne illness
– for example, establishing the President's Council on Food Safety, issuing specific directives
such as the Egg Safety Action Plan, and funding requests for other targeted food safety initiatives.
Listeria monocytogenes (LM), a harmful bacterium that can be found in a variety of foods, causes
an estimated 2,500 illnesses annually in the U.S., with about 500 (20 percent) of these cases
resulting in death. Pregnant women, newborns, the elderly, and those with compromised immune
systems are at highest risk of infection and complications of illness. But many of these illnesses
can be prevented.
On May 5, 2000, the President directed the Secretary of Health and Human Services (HHS) and
the Secretary of Agriculture (USDA) to identify aggressive steps to significantly reduce the risk of
illness and death from LM in ready-to-eat foods. Specifically, the President's directive called for
a 50 percent reduction in the number of LM illnesses by the year 2005 – five years ahead of the
previously established Healthy People 2010 target.
The President directed the Secretary of HHS to develop an action plan identifying additional steps
necessary to reduce LM contamination. He specifically directed that the HHS plan include
consideration of control measures for at-risk foods; publication of guidance for processors,
retailers, and food service facilities; and consideration of enhanced labeling to provide additional
safeguards for consumers.
The President also directed the Secretary of Agriculture to report back within 120 days on the
"aggressive steps you will take to significantly reduce the risk of illness and death by
Listeria monocytogenes." The President in particular directed the Secretary of Agriculture to "complete
proposed regulations that include any appropriate microbiological testing and other industry
measures" to prevent cross-contamination in the processing environment; ensure that the
processing of ready-to-eat products meets appropriate standards; and ensure that such products are
safe throughout their shelf-life.
Taken together, the activities in the joint action plan are designed to achieve the President's goal of
reducing LM-related illnesses by 50 percent by 2005. In his directive the President called for a
status report from HHS and USDA within 120 days – that is, by September 5, 2000.
II. This Action Plan
This action plan outlines the steps HHS and USDA will take to reduce LM illnesses associated
with consumption of ready-to-eat foods within the regulatory purview of HHS' Food and Drug
Administration (FDA) and the USDA's Food Safety and Inspection Service (FSIS). The plan
focuses on those food categories identified in the FDA/FSIS risk assessment as either warranting
additional measures to reduce LM contamination or warranting collection of additional data.
The actions will be undertaken in consultation with State and local health officials, consumers,
industry, and academia. In planning and implementing the actions listed below, FDA and USDA-
FSIS also plan to hold public meetings to gain stakeholder input.
This action plan will be posted on the interagency web site,
www.foodsafety.gov; the FDA web site, www.cfsan.fda.gov; and the
FSIS web site, www.fsis.usda.gov.
To address risks from LM, the two Federal agencies plan to:
- Enhance consumer and health care provider information and education efforts;
- Develop and revise guidance for processors, retailers, and food service/institutional
establishments that manufacture or prepare ready-to-eat foods;
- Develop and deliver training / technical assistance for industry and food safety regulatory employees;
- Review and redirect enforcement and regulatory strategies including microbial product sampling;
- Propose new regulations and revisions to existing regulations as needed;
- Enhance disease surveillance and outbreak response;
- Initiate projects with retail operations such as delicatessens and salad bars to pilot LM
control measures including employee practices; and
- Coordinate research activities to refine the risk assessment, enhance preventive
controls, and support regulatory, enforcement and educational activities.
III. Participants
Within HHS, the FDA and the Centers for Disease Control and Prevention (CDC) have the
primary responsibility for implementation of this action plan. Within USDA, the agencies with
primary responsibility for implementing this action plan are: the Food Safety and Inspection
Service (FSIS), the Food and Nutrition Service (FNS), the Agricultural Marketing Service
(AMS), the Agricultural Research Service (ARS), and the Cooperative State Research, Education
and Extension Service (CSREES). The Under Secretary for Food Safety coordinates USDA
responses on cross-cutting food safety issues. HHS and USDA will continue to work in
partnership to achieve the target of a 50 percent reduction in LM illnesses by 2005.
IV. Action Areas
Objective 1:
Enhance consumer and health care provider information and education efforts.
Timeline: In 2001
Action:
HHS and USDA will collaborate with their public health counterparts to further develop and
disseminate to consumers and health care providers appropriate information and educational
messages about the prevention of Listeria-related illness. Educational efforts will be revised, as
appropriate, based on the findings of the LM risk assessment. The agencies will undertake
educational initiatives to achieve the following:
- focus consumer messages on safely selecting, storing, handling, and preparing foods;
- tailor information to target populations (for example, specific recommendations tailored
for higher-risk groups including pregnant women and the immune-compromised);
- inform and educate health care professionals about the diagnosis, treatment, and
prevention of Listeria-related illness;
- develop medical guidance for specialty physicians and other health care professionals;
- encourage health care professionals to provide counseling for at-risk patients;
- obtain maximum outreach to women and women's health care professionals by coordinating education efforts with
the DHHS Office of Women's Health and other agencies within HHS;
- collaborate with other public and private organizations (such as CSREES, FNS, the
Partnership for Food Safety Education, consumer groups, professional associations, providers
and/or health care organizations) to maximize the effectiveness of outreach efforts.
In conducting their educational activities, the agencies will expand their use of new technologies
such as satellite video conferencing and computer-based and interactive web training.
Objective 2:
Develop and revise guidance for processors, retailers, and food service
establishments/institutions that manufacture or prepare ready-to-eat foods.
Timeline: Starting now through 2002
Action:
To achieve this objective, the following steps will be taken:
- FDA will develop and propose guidance for processors identifying preventive controls for
LM, with an emphasis on post-process contamination controls and measures including
sanitation practices and environmental sampling.
- FDA will review and revise the Food Code – the agency's existing guidance for retailers and food service
establishments – to address preventive controls such as cold holding times and temperatures.
- FSIS will publish guidance to industry on appropriate intervention measures by which
meat and poultry plants could reduce the risk of LM from hot dogs and sliced luncheon
meats. This guidance will be developed in conjunction with rulemaking in Objective 5.
Objective 3:
Develop and deliver training / technical assistance for industry and food safety regulatory employees.
Timeline: Starting now through 2002
Action:
HHS and USDA will take the following steps toward enhanced training and technical assistance:
- review existing FDA/FSIS training / technical assistance programs for regulatory and
industry employees and revise, as needed, based on the findings of the LM risk assessment.
The training will include a segment on LM and preventive and post-process contamination
controls and a segment on auditing the effectiveness of these controls. Make training
available for investigators, inspectors, State and local regulatory officials, Public Affairs
Specialists who interact with consumers, and processors of ready-to-eat foods, including
retail and food service establishments and institutions.
- provide technical assistance to small and very small meat and poultry plants.
- In addition to its ongoing training programs for inspectors and state, local and foreign
government officials, USDA will utilize public private partnership training groups, internet
and software-based programming and curricula; and the land-grant university and extension-
based network for appropriate training.
- make training modules available for long distance training; e.g. satellite-based training,
computer-based training with an interactive web site.
Objective 4:
Review and redirect enforcement and regulatory strategies including microbial product sampling.
Timeline: Beginning 2001
Action:
Toward this objective, the following steps will be taken:
- FDA will increase inspections of domestic establishments that prepare or produce ready-to-
eat products that are identified in the risk assessment as either warranting additional measures
to reduce LM contamination or warranting collection of additional data. Also, FDA will
modify these inspection programs to focus additional efforts on post-process contamination
potential, sanitation practices, and environmental testing programs.
- FDA will undertake surveillance sampling and LM testing of ready-to-eat domestically
produced products that are identified in the risk assessment as either warranting additional
measures to reduce LM contamination or warranting collection of additional data. For
imported foods, the agency will step up finished product sampling and LM testing of similar
ready-to-eat foods. The agency will use inspection guides, the FDA web page, and/or FDA
memoranda to communicate product sampling criteria and analytical methodology to Federal and State regulators.
- FSIS will revise its microbiological sampling programs for ready-to-eat meat and poultry
products to more effectively target establishments that produce ready-to-eat products, thus
improving the Agency's HACCP verification capabilities. FSIS has developed new
instructions for meat and poultry inspectors that clarify the role of FSIS microbiological
sampling of ready-to-eat products under HACCP. The Pathogen Reduction and HACCP rule
requires all manufacturers of ready-to-eat products to validate their processes, and a May
1999 FSIS notice clarified that all manufacturers of meat and poultry products should
reassess their HACCP plans to determine whether they adequately address the hazard from
LM with full HACCP implementation.
- FSIS will work with the Agricultural Marketing Service (AMS) and the Food and Nutrition
Service (FNS) to advance the use of instructional labeling for safe use of ready-to-eat
meat and poultry foods by modifying the specifications for these foods that are purchased
for USDA commodity food programs such as the following: school breakfast and lunch;
the Commodity Supplemental Food Program (CSFP); and the Food Distribution Program
on Indian Reservations (FDPIR). Many ready-to-eat foods are purchased for ultimate
consumption by immune-compromised and other at-risk individuals. For example, the
CSFP reaches pregnant women, who are vulnerable to spontaneous late-term abortion from listeriosis.
- FSIS is using its draft protocol for in-depth verification reviews of the regulatory
compliance and scientific validity of a company's HACCP system. FSIS is reviewing
enforcement strategies to ensure that ready-to-eat meat and poultry products are not contaminated with pathogens.
Objective 5:
Propose new regulations and revisions to existing regulations, as needed.
Timeline: Starting now through 2004
Action:
Steps toward the most effective regulatory framework include the following:
- Consistent with guidance announced in the Federal Register of Jan. 5, 1999 (64 FR 517-518), FDA has already begun
expediting the review of food additive petitions for LM control interventions. For example, the agency is currently
reviewing a food additive petition filed in October 1999 for the use of irradiation to reduce the level of LM and
other pathogens in a variety of foods.
- FSIS will propose regulations governing all ready-to-eat and partially heat-treated meat and poultry products.
- FDA and FSIS will seek advice from a scientific advisory committee on the scientific basis
for establishing safety-based "use by" date labeling for refrigerated, ready-to-eat foods. FDA
will evaluate the need for a new regulation requiring processors and retailers to label
packages of certain foods with a validated safety-based "use by" date. In addition, FDA will
evaluate the need for a regulation requiring safety-based "keep refrigerated" labeling for
certain refrigerated, ready-to-eat foods that are identified in the risk assessment as warranting
additional measures for reducing LM contamination and support the growth of LM.
- FDA will review its current Good Manufacturing Practice regulations and evaluate whether
to propose changes to include Sanitation Standard Operating Procedures (SSOPs) and
environmental sampling in those regulations, and reduce the storage temperature for certain
ready-to-eat foods based on the findings in the risk assessment.
- FDA will review the adequacy of LM controls in existing regulations and standards of
identity for those products identified in the risk assessment as either warranting additional
measures for reducing LM contamination or warranting collection of additional data. For
example, FDA will consider establishing a standard of identity for fresh soft cheese
requiring the use of pasteurized milk. FDA will also consider revising the soft ripened
cheese standard of identity to require use of pasteurized milk.
- Utilizing LM data gathered through FDA's regulatory product surveillance testing, in
combination with data generated from exposure assessment studies, the FDA will revise its
regulations and enforcement policies as necessary to maximize public health protection.
Objective 6:
Enhance Disease Surveillance and Outbreak Response
Timeline: Starting now through 2004
Action:
The following steps will enhance the effectiveness of LM surveillance and outbreak response:
- To detect illness outbreaks more quickly and accurately, the number of laboratories capable
of LM analysis through CDC's "PulseNet" laboratory network will be more than doubled –
from 20 in 1999 to 45 in 2001. CDC also is developing a centralized, computerized library of
LM DNA "fingerprints" for cross-matching bacterial samples, and will examine additional
methods for rapid subtyping of pathogenic LM strains. FDA and FSIS will improve the
ability and speed with which positive LM isolates taken from ready-to-eat food products and
environmental samples are submitted to PulseNet for cross matching with human isolates.
These enhancements will enable the Federal regulatory agencies and State and local public
health officials to more quickly investigate illness outbreaks and trace food product sources,
and more effectively limit the spread of illness.
- CDC will continue working with State and local health departments and health professionals
to improve the detection and reporting of LM illnesses and learn more about the frequency
and severity of LM illness. CDC will conduct enhanced public health monitoring of LM
illness to identify and evaluate trends in disease occurrence to help measure the impact of the
agencies prevention activities.
- CDC also has initiated a comprehensive case-control study, targeted for completion in 2002,
to gather additional information about these illnesses, risk factors for acquiring infection, and
opportunities for prevention. In this study, CDC will collaborate with FDA, FSIS, and many
State health departments, particularly through the joint Foodborne Diseases Active
Surveillance Network (FoodNet) project. These efforts are intended to provide better
information about special risks to vulnerable populations (such as pregnant women,
newborns, and the elderly) and help to identify additional high-risk foods.
Objective 7:
Initiate projects with retail operations such as delicatessens and salad bars to pilot LM control
measures including employee practices.
Timeline: Starting now through 2002
Action:
Steps toward improved LM control measures at the retail level include:
- FDA will, in consultation with industry and state counterparts, design a project to be
implemented with retail operations such as delicatessens and salad bars to pilot LM control
measures including employee practices. FDA will coordinate the implementation of the
program with CDC in 2001, and based on the project outcome, propose programs for
implementation across all such operations.
- FSIS will cooperate with FDA and the states on activities directed toward improved LM control measures at
the retail level.
Objective 8:
Coordinate research activities to refine the risk assessment, enhance preventive controls and
support regulatory, enforcement and educational activities.
Timeline: Starting now through 2004
Action:
Coordinating such research efforts will entail the following steps:
- Starting now for delivery the end of 2001, FDA will fund exposure assessment studies on
FDA-regulated products to obtain additional data to address the limitations for specific food
categories identified in the LM risk assessment. FDA, through the Joint Institute of Food
Safety and Applied Nutrition (JIFSAN), has initiated an LM exposure assessment study for
retail samples in two active surveillance (FoodNet) sites. FDA will utilize these data and
regulatory product surveillance data to evaluate and revise, as necessary, regulations and
enforcement policy so as to maximize public health protection.
- FDA will coordinate and conduct research to provide additional information about
commercial treatments, including preservatives, irradiation, and other technologies, that can
eliminate LM or prevent its growth in ready-to-eat foods. FDA will initiate research for
specific food commodities to establish the basis for safety-related date marking for processors.
- USDA's Agricultural Research Service will continue work on a multi-year study initiated at
the request of FSIS to examine the prevalence of LM in a ready-to-eat product (hotdogs)
under a variety of storage conditions. The study will produce data that will address several
important information gaps, including the prevalence, levels and types of LM in frankfurters
during their shelf life, extending from manufacture to 3 months of storage.
- FDA will undertake research into better methods of detection and quantification of LM and
generally into the pathogen's food-related sources and disease factors.
VI. Conclusion
By undertaking the actions contained in this joint action plan, HHS and USDA intend to meet the
President's May 5, 2000, directive to reduce LM-related disease by 50 percent by the year 2005.
National Food Safety Initiative
|
Listeria Draft Risk Assessment: Table of Contents
CFSAN Home
|
FSIS Home
|
CDC Home | Search/Subject Index
|
Disclaimers & Privacy Policy
Hypertext updated by dav/cjm/dms 2001-MAY-08