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L. monocytogenes is a bacterium that can cause a serious infection in humans called listeriosis, and causes an estimated 2,500 serious illnesses and 500 deaths each year. Foodborne illness caused by L. monocytogenes in pregnant women can result in miscarriage, fetal death, and severe illness or death of a newborn infant. Others at risk for severe illness or death are older adults and those with weakened immune systems.

"Listeria is a serious public health concern because it can be life threatening," said Health and Human Services Secretary Donna E. Shalala. "Listeriosis, the disease caused by Listeria, primarily affects pregnant women, older adults and persons with weakened immune systems. The Listeria risk assessment and action plan are steps to help protect these individuals."

"This comprehensive plan is yet another step forward in the Clinton administration's long and successful record of improving the safety of the nation's food supply, already the safest in the world," said Agriculture Secretary Dan Glickman. " At USDA, the science-based meat and poultry inspection system has contributed to a decline in foodborne illnesses."

On May 5, 2000, the President directed the Secretary of Health and Human Services and the Secretary of Agriculture, who co-chair the President's Council on Food Safety, to identify aggressive steps to reduce significantly the risk of illness and death from L. monocytogenes in ready-to-eat foods. The President called for a 50 percent reduction of the number of Listeria related illnesses by 2005 -- five years ahead of the previously established Healthy People 2010 target.

The risk assessment was designed to predict the potential relative risk of listeriosis among three age-based groups of people - perinatal, elderly, and intermediate-age from eating certain ready-to-eat foods. This draft risk assessment evaluated foods within 20 categories considered to be the principal sources of L. monocytogenes. The results of this assessment will assist both HHS and USDA in evaluating the adequacy of current programs, help in the development of new programs to ensure that current efforts protect the public health, and help to evaluate the effectiveness of new strategies to minimize the public health impact of foodborne L. monocytogenes.

The main findings from the risk assessment are:

1. The risk assessment reinforces past conclusions that foodborne listeriosis is a moderately rare although severe disease.
2. The risk assessment also supports the findings of epidemiological investigations of both sporadic illness and outbreaks of listeriosis, e.g., pâté, fresh soft cheeses, smoked seafood, frankfurters (hot dogs), and some foods from deli counters, as potential vehicles of listeriosis for susceptible populations.
3. Five factors affect consumer exposure to L. monocytogenes at the time of food consumption.
   • Amount and frequency of consumption of a food.
   • Frequency and levels of L. monocytogenes in ready-to-eat food.
   • Potential to support growth of L. monocytogenes in food during refrigerated storage.
   • Refrigerated storage temperature.
   • Duration of refrigerated storage before consumption.
4. New case control studies are needed to reflect changes in food processing, distribution patterns, preparation, and consumption practices.

To ensure food safety and because Listeria monocytogenes can grow at refrigerator temperatures, FDA and FSIS advise all consumers to reduce the risk of illness by:

• Using perishable items that are precooked or ready-to-eat as soon as possible;

• Cleaning their refrigerators regularly; and

• Using a refrigerator thermometer to make sure that the refrigerator always stays at 40 degrees F or below.

Since pregnant women, older adults, and people with weakened immune systems are at higher risk for listeriosis, FDA and FSIS provide the following advice to those at-risk consumers of foods that have a greater likelihood of containing Listeria monocytogenes:

• Do not eat hot dogs and luncheon meats, unless they are reheated until steaming hot.

• Do not eat soft cheeses such as Feta, Brie and Camembert cheeses, blue-veined cheeses, and Mexican-style cheeses such as "queso blanco fresco."

Cheeses that may be eaten include hard cheeses; semi-soft cheeses such as mozzarella; pasteurized processed cheeses such as slices and spreads; cream cheese; and cottage cheese.

• Do not eat refrigerated pâtés or meat spreads. Canned or shelf-stable pâtés and meat spreads may be eaten.

• Do not eat refrigerated smoked seafood, unless it is contained in a cooked dish, such as a casserole. Refrigerated smoked seafood, such as salmon, trout, whitefish, cod, tuna or mackerel, is most often labeled as "nova-style," "lox," "kippered," "smoked," or "jerky." The fish is found in the refrigerator section or sold at deli counters of grocery stores and delicatessens. Canned or shelf-stable smoked seafood may be eaten.

• Do not drink raw (unpasteurized) milk or eat foods that contain unpasteurized milk.

To keep food safe from harmful bacteria, follow these four simple steps:

Clean: Wash hands and surfaces often
Separate: Don't cross-contaminate
Cook: Cook to proper temperatures
Chill: Refrigerate promptly

The HHS and USDA Joint Action Plan, which is based on the draft risk assessment, includes the following proposed action items:

• Provide guidance for those that manufacture or prepare ready-to-eat foods.
• Provide training or technical assistance for industry and food safety regulatory employees.
• 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.
• Enhance control measures for L. monocytogenes at retail/delis.
• Conduct additional research such as exposure assessment studies, manufacturer/processor treatment strategies, safety-related date marking, prevalence of L. monocytogenes in frankfurters (hot dogs), and detection and quantitation methods for L. monocytogenes.
• Enhance consumer and health care provider information and education efforts.

Written comments on the Action Plan and the Risk Assessment will be received until March 20, 2001, as stated in the Federal Register and may be addressed to Dockets Management Branch (HFA-305), Docket # 99N-1168, Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Md. 20852 or FSIS Docket Clerk, Docket #00-048N, U.S. Department of Agriculture, Food Safety and Inspection Service, Room 102, Cotton Annex, 300 12th Street, S.W., Washington, D.C. 20250-3700.

FDA and FSIS also intend to conduct a public meeting to present and discuss these activities. The risk assessment and the Action Plan are also available on the Web at www.foodsafety.gov/, the FDA Web site at www.cfsan.fda.gov/ and the FSIS Web site, www.fsis.usda.gov.

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