FDA/Center for Food Safety and Applied Nutrition
Centers for Disease Control and Prevention
November 2003



Reducing the Risk of Listeria monocytogenes
FDA/CDC 2003 Update of the Listeria Action Plan

Executive Summary
Update of the Listeria Action Plan


Executive Summary

Listeria monocytogenes (L. monocytogenes) is a harmful bacterium that can be found in a variety of foods. In pregnant women, L. monocytogenes 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 L. monocytogenes contaminated food.

The Healthy People 2010 goals for national health promotion and disease prevention called on federal food safety agencies to reduce foodborne listeriosis by 50% by the end of the year 2005. Preliminary FoodNet data on the incidence of foodborne illness for the United States in 2001 indicated that the incidence of infection from L. monocytogenes decreased between 1996 and 2001 from 0.5 to 0.3 cases per 100,000 people per year. The level then reached a plateau. It became evident that, in order to reduce further the incidence to a level of 0.25 cases per 100,000 people by the end of 2005, additional targeted measures were needed. The L. monocytogenes Risk Assessment was initiated as an evaluation tool in support of this goal. The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) have reviewed ongoing L. monocytogenes prevention and control activities and have developed an action plan, which includes activities targeted at the serious problem of L. monocytogenes caused illness.

For more than 15 years, the Department of Health and Human Services (HHS), FDA, CDC, along with other Federal, State, and local agencies, has been working toward preventing L. monocytogenes illness and controlling this pathogen. In recent years, HHS, along with the United States Department of Agriculture (USDA), conducted a risk assessment of L. monocytogenes (Quantitative Assessment of The Relative Risk to Public Health from Foodborne L. monocytogenes Among Selected Categories of Ready-to-Eat Foods) in order to understand better both the health risk posed by the bacterium and the associated food vehicles that can transmit the pathogen. Results from the Risk Assessment support the need for additional targeted public health action.

This Action Plan complements the work of the Risk Assessment, focusing on certain ready-to-eat foods that can potentially become contaminated with L. monocytogenes. This revised plan updates the FDA and CDC components of the Action Plan (Joint Response to the President: Reducing the Risk of L. monocytogenes) that was previously released in January 2001. The modifications in the plan have been undertaken, in part, to reflect the 2003 updating of the Risk Assessment. This plan seeks to reduce significantly the risk of illness and death caused by L. monocytogenes in ready-to-eat foods with consideration of control measures for at-risk foods.

FDA and CDC have identified six areas for action:

  1. Develop and revise guidance for processors that manufacture or prepare ready-to-eat foods and develop or revise guidance for retail and food service and institutional establishments.
  2. Develop and deliver training and technical assistance for industry and food safety regulatory employees.
  3. Enhance consumer and health care provider information and education efforts.
  4. Review, redirect, and revise enforcement and regulatory strategies, including microbial product sampling.
  5. Enhance disease surveillance and outbreak response.
  6. 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.


Reducing the Risk of Listeria monocytogenes
FDA/CDC 2003 Update of the Listeria Action Plan

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 Federal agencies responsible for food safety have repeatedly taken action to enhance the safety of the U.S. food supply and reduce foodborne illness.

Listeria monocytogenes (L. monocytogenes), is a harmful bacterium that can be found in a variety of foods. In pregnant women illness caused by L. monocytogenes 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 L. monocytogenes -contaminated food. 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.

The Healthy People 2010 goals for national health promotion and disease prevention called on Federal food safety agencies to reduce foodborne listeriosis by 50% by the end of the year 2005. Preliminary FoodNet data on the incidence of foodborne illnesses for the United States in 2001 indicated that the incidence of infection from L. monocytogenes decreased between 1996 and 2001 from 0.5 to 0.3 cases per 100,000 people per year. The level then reached a plateau. In order to reduce the incidence to a level of 0.25 cases per 100,000 people by the end of 2005 it became evident that additional targeted measures were needed. The L. monocytogenes risk assessment was initiated as an evaluation tool in support of this goal. The purpose of the assessment was to systematically examine available scientific data and information to estimate the relative risks of serious illness and death associated with consumption of different types of ready-to-eat (RTE) foods that may be contaminated with L. monocytogenes. The risk assessment, which was published in draft form in 2001 and published in final form in 2003, provides analyses and models that (1) estimate the potential level of exposure of three age-based population groups and the total United States population to L. monocytogenes contaminated foods for 23 food categories and (2) relate this exposure to public health consequences. The food categories consist of foods with a documented history of L. monocytogenes contamination. This examination of the current science and the models developed from it are among the tools that food safety regulatory agencies may use to evaluate the effectiveness of current and future policies, programs and regulatory practices to minimize the public health impact of this pathogen and is the foundation of this response.

In 2001, the Department of Health and Human Services (HHS) and the United States Department of Agriculture (USDA) reviewed ongoing L. monocytogenes prevention and control activities and developed an action plan, published in 2001, which included activities targeted at the serious problem of L. monocytogenes caused illness. The 2001 Action Plan included 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. This 2003 Action Plan is an update of the FDA/CDC components of the 2001 Action Plan.

Taken together, the activities in the action plan are designed to achieve the Healthy People 2010 goal of reducing L. monocytogenes caused illness by 50 percent by 2005.

II. This Updated Action Plan

This revised and updated Action Plan outlines the steps FDA and CDC will take to reduce L. monocytogenes illnesses associated with consumption of ready-to-eat foods within the regulatory purview of the Food and Drug Administration (FDA). The plan focuses on those food categories identified in the FDA/USDA risk assessment as either warranting additional measures to reduce L. monocytogenes contamination or warranting collection of additional data.

The actions will be undertaken in consultation with other Federal agencies, State and local health officials, consumers, industry, and academia. In planning and implementing the actions listed below, FDA also plans to hold public meetings to receive stakeholder input.

This Action Plan will be posted on the interagency web site, www.foodsafety.gov, and the FDA web site, www.cfsan.fda.gov.

To address risks from L. monocytogenes, FDA and CDC plan to:

  1. Develop and revise guidance for processors that manufacture or prepare ready-to-eat foods and develop or revise guidance for retail and food service and institutional establishments.
  2. Develop and deliver training and technical assistance for industry and food safety regulatory employees.
  3. Enhance consumer and health care provider information and education efforts.
  4. Review, redirect, and revise enforcement and regulatory strategies, including microbial product sampling.
  5. Enhance disease surveillance and outbreak response.
  6. Coordinate research activities to refine the Risk Assessment, enhance preventive controls, and support regulatory, enforcement, and educational activities.

III. Participants

FDA and the CDC have the primary responsibility for implementation of this action plan. FDA and CDC will continue to work in partnership with other agencies to achieve the target of a 50 percent reduction in L. monocytogenes illnesses by 2005.

IV. Action Areas

Objective 1:
Develop and revise guidance for processors that manufacture or prepare ready-to-eat foods and develop or revise guidance for retail and food service and institutional establishments.

Timeline: Present through 2005

Action:
To achieve this objective, the following steps are planned:

Objective 2:
Develop and deliver training and technical assistance for industry and food safety regulatory employees.

Timeline: Present through 2005

Action:
FDA and CDC plan to take the following steps toward enhanced training and technical assistance:

Objective 3:
Enhance consumer and health care provider information and education efforts.

Timeline: Present through 2005

Action:
FDA and CDC will collaborate with their public health counterparts to develop further and disseminate to consumers and health care providers appropriate information and educational messages about the prevention of L. monocytogenes caused illness. Educational efforts will be revised, as appropriate, based on the findings of the L. monocytogenes Risk Assessment. FDA and CDC plan to undertake educational initiatives to achieve the following:

In conducting its educational activities, FDA and CDC will expand their use of new technologies such as satellite video conferencing and computer-based and interactive web training.

Objective 4:
Review, redirect, and revise enforcement and regulatory strategies including microbial product sampling.

Timeline: Present through 2005

Action:
Toward this objective, the following steps are planned:

Objective 5:
Enhance Disease Surveillance and Outbreak Response

Timeline: Present through 2005

Action:
The following steps will enhance the effectiveness of L. monocytogenes surveillance and outbreak response:

Objective 6:
Coordinate research activities to refine the Risk Assessment, enhance preventive controls, and support regulatory, enforcement, and educational activities.

Timeline: Present through 2005

Action:
Coordinating such research efforts will entail the following steps:

VI. Conclusion

By undertaking the actions contained in this action plan, FDA and CDC, working with USDA, intend to meet the Healthy People 2010 goal to reduce L. monocytogenes caused illness by 50 percent by the year 2005.


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