FDA/Center for Food Safety and Applied Nutrition USDA/Food Safety and Inspection Service Centers for Disease Control and Prevention January 2001

EXECUTIVE SUMMARY

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:

1. Enhance consumer and health care provider information and education efforts.
2. Develop and revise guidance for processors, retailers, and food service/institutional establishments that manufacture or prepare ready-to-eat foods.
3. Develop and deliver training/technical assistance for industry and food safety regulatory employees.
4. Review and redirect enforcement and regulatory strategies including microbial product sampling.
5. Propose new regulations and revisions to existing regulations, as needed.
6. Enhance disease surveillance and outbreak response.
7. Initiate projects with retail operations such as delicatessens and salad bars to pilot LM control measures including employee practices.
8. 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:
- PulseNet Expansion	X	X
- Case-Control Study	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

I. Background

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

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:

1. Enhance consumer and health care provider information and education efforts;
2. Develop and revise guidance for processors, retailers, and food service/institutional establishments that manufacture or prepare ready-to-eat foods;
3. Develop and deliver training / technical assistance for industry and food safety regulatory employees;
4. Review and redirect enforcement and regulatory strategies including microbial product sampling;
5. Propose new regulations and revisions to existing regulations as needed;
6. Enhance disease surveillance and outbreak response;
7. Initiate projects with retail operations such as delicatessens and salad bars to pilot LM control measures including employee practices; and
8. Coordinate research activities to refine the risk assessment, enhance preventive controls, and support regulatory, enforcement and educational activities.

III. Participants

IV. Action Areas

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

Hypertext updated by dav/cjm/dms 2001-MAY-08