This guidance provides practical recommendations that retailers can use to control Lm contamination and outgrowth in the deli area based on the findings of the Interagency Retail Lm Risk Assessment, available scientific knowledge, the 2013 FDA Food Code, as well as lessons learned from controlling Lm in meat and poultry processing establishments. Retailers can use this best-practices guidance to help ensure that RTE meat and poultry products in the deli area are handled under sanitary conditions and are not adulterated as defined in the FMIA and PPIA. While these practices are designed to control Lm specifically, they also may help control other food borne pathogens that may be introduced into the retail deli environment and other facilities where consumers take possession of food.

The best practices are divided into four sections: (1) product and product handling, (2) cleaning and sanitizing, (3) facility and equipment controls, and (4) employee practices. Practices identified by the risk assessment that can significantly decrease the predicted risk of foodborne illness are highlighted in each section. The other practices that are based on scientific knowledge or lessons learned also will help retailers increase Listeria control in the deli area. For example, although floors and drains were not considered as a source of cross-contamination according to the Interagency Retail Lm Risk Assessment, FSIS data has shown that floors, drains, and items like floor mats tend to be harborage points in FSIS establishments. Providing this information can assist retailers in controlling Lm in the deli area. A self-assessment tool, starting on page 14 of this guidance, is provided for deli operators to help them identify the best practices they are using and to assess whether they need to adopt others. By following the best practices in the guidance and the 2013 FDA Food Code, retailers can help ensure that RTE products are not adulterated with Lm, and that the potential for listeriosis is decreased.

NOTE: Retailers should be aware that the recommendations in this guidance, especially those based on the 2013 Food Code may be requirements in State, local, or tribal regulations. Questions on this guidance may be submitted through askFSIS.

The Interagency Retail Lm Risk Assessment found that using practices that prevent bacterial growth in the product substantially reduced the predicted risk of listeriosis. In addition, while the risk assessment showed that the risk from incoming Lm-contaminated products that do not support growth is low, it also showed that these products can cross-contaminate RTE products that support growth, and when they do, the risk increases substantially. The formulation of RTE products with antimicrobial agents prevents growth of Lm in RTE foods both at retail and during consumer home storage, leading to an overall reduction in the predicted risk of listeriosis. The 2013 FDA Food Code (3-501.16(A)(2)) recommends keeping RTE products at or below 41°F (5°C), which slows the growth of Lm in the deli and decreases the predicted risk for listeriosis. Other scientific studies also have shown that preventing product contamination reduces the risk of foodborne illness.

Therefore, it is important for retailers to adopt practices that protect RTE product from contamination with Lm and to use strategies to prevent or limit the growth of Lm in deli products. Below are a few such strategies.

• Use products formulated with antimicrobial agents (e.g., acetic acid, sodium diacetate, lactic acid, citric acid) when possible, to eliminate or prevent the growth of Lm in RTE products. In some cases, the addition of antimicrobial agents may not be possible because of the adverse effect on the flavor of the products. Retailers can read the ingredients statements on the labels to see whether the products in the deli have antimicrobial agents and can contact their suppliers to determine whether products formulated with antimicrobial agents are available.
  
  NOTE: As stated previously, the Interagency Retail Lm Risk Assessment estimated that if antimicrobial agents are used in all products in the deli, the predicted risk of listeriosis from the consumption of RTE products sliced or prepared in retail departments could be decreased by approximately 96%.
• Use products that have been treated to reduce pathogens (e.g., through high pressure processing (HPP)). This information can be determined from certificates of analysis (COA), letters of guarantee (LOG), or other information from suppliers. Separate products that support growth from products that do not support growth (when possible) to help prevent cross contamination.
  
  NOTE: As stated previously, the Interagency Retail Lm Risk Assessment found that if current levels of Lm in RTE foods (e.g., meats, cheeses, and salads) received by the retail deli were reduced by half, the predicted risk of listeriosis from the consumption of RTE products sliced or prepared in retail deli departments could be decreased by approximately 22%.
• Monitor the shelf life of an RTE product that is opened, prepared, and held in a retail setting for more than 24 hours. To monitor shelf life of the opened product, retailers should date-mark the product (e.g., clearly mark it with the date of opening and the discard date) as recommended by the 2013 FDA Food Code (3-501.17). Products also should be properly identified and labeled. RTE products that are past their shelf life should be discarded.
• Do not pre-slice products in the morning, after cleaning. Retailers should slice the product at the time it is requested by consumers.
  
  NOTE: The Interagency Retail Lm Risk Assessment found that pre-slicing the product increases the predicted risk of listeriosis from the consumption of RTE products sliced or prepared in retail deli departments by approximately 6%.
• Remove products that are filthy, putrid, decomposed, slimy, rancid, or in off-condition, which are considered adulterated, from the deli area as soon as possible. Thoroughly clean and sanitize areas that were contacted by the affected product to prevent any cross-contamination.
• Promptly return RTE products to refrigerated units, after slicing, to prevent pathogen growth. Maintain refrigeration units at or below 41°F (5°C) to slow the growth of Lm, as recommended by the 2013 FDA Food Code (3-501.16(A)(2)). RTE products should be covered, wrapped, or otherwise protected to prevent cross-contamination when not in use.
  
  NOTE: The Interagency Retail Lm Risk Assessment found that storing the products at or below 41°F (5°C) decreases the predicted risk of listeriosis from the consumption of RTE products sliced or prepared in retail deli departments by approximately 9%.
• Store and handle RTE products in separate areas from raw products. RTE products that are prepared, held, or stored near raw products can become contaminated (e.g., because of aerosolization or dripping). The 2013 FDA Food Code (3-302.11(A)(1)) recommends that retailers separate RTE foods from raw foods. If storage space is limited, wrap the products and store RTE products above raw products. When wrapping, unwrapping, and slicing products, take care to prevent cross-contamination from the outer wrapper, other products, and unclean surfaces and utensils. Raw products (e.g., chicken used for frying or rotisserie) prepared in the same area as RTE products can increase the potential for cross-contamination.
• Clean and sanitize surfaces between RTE items when using the same equipment to cut, slice, or otherwise reduce the size of large RTE products (e.g., ham, seafood, and vegetables).
• Ensure that grinders, dicers, or other equipment are maintained in sanitary condition when preparing deli salads.

The Interagency Retail Lm Risk Assessment found that following the sanitation practices in the 2013 FDA Food Code aid in controlling Lm on deli area food contact surfaces and reduces the predicted risk of listeriosis. The 2013 FDA Food Code (4-602.11(C)) recommends cleaning equipment and utensils at least every 4 hours. Below are some key issues to consider when cleaning and sanitizing.

• Develop written sanitation procedures that describe how utensils and equipment (e.g., slicers) will be cleaned and sanitized prior to use. Ensure employees are familiar with and follow these procedures to reduce the risk of contaminating RTE products with Lm. Insanitary conditions (e.g., flies, rodent droppings, mold, or dirty surfaces) should not be present in retail areas. Retailers should document the actions they perform to ensure that sanitation procedures are performed on a regular basis.
  
  NOTE: The Interagency Retail Lm Risk Assessment found that the predicted risk of listeriosis from the consumption of RTE products sliced or prepared in retail deli departments increases by approximately 41% if wiping, washing, and sanitizing activities are not performed.
• Clean and sanitize utensils and equipment used to handle, prepare, and store RTE products frequently (e.g., at least every 4 hours as recommended by the 2013 FDA Food Code (4-602.11 (C)) to maintain sanitary conditions throughout the day. Clean and sanitize items that employees routinely handle, such as on/off switches, slicer handles, display cases, cooler handles, and similar surfaces.
  
  NOTE: As stated previously, the Interagency Retail Lm Risk Assessment found that slicers are sources of Lm cross-contamination to RTE foods. Control of Lm cross-contamination at all points (including slicers) during retail preparation and handling of RTE foods will reduce the predicted risk of listeriosis from the consumption of RTE products sliced or prepared in retail deli departments by approximately 34%.
• Disassemble RTE food-processing equipment when cleaning and sanitizing equipment as recommended by the Food Code to ensure that hard to reach areas where Lm can hide are addressed. For more information, see the FDA poster: Keep Commercial Deli Slicers Safe.
• Scrub surfaces during cleaning to prevent biofilms from occurring. Biofilms are thin layers of microorganisms that adhere to product contact surfaces. Lm and other bacteria can adapt to the environment over time and form biofilms. Biofilms are difficult to remove, and they may protect Lm from the effects of sanitizers.
• Follow the manufacturer’s recommendations for sanitizer strength and application to ensure it is effective. Many sanitizers, when used as recommended, are effective against Lm, including those containing quaternary ammonia compounds, chlorine solutions, and organic acids. Generally, increasing the sanitizer strength above the recommended levels will not increase the efficacy of the sanitizer and may result in harmful levels of the sanitizer in foods.
• Rotate (change) sanitizers as needed to provide more effective bacterial control. Alternating sanitizers (e.g., quaternary ammonia and bleach) may help prevent Lm from establishing niches in the environment and forming biofilms. For example, retailers can use quaternary ammonia on the week days and bleach on the weekends when rotating sanitizers.
• Develop a procedure to sanitize cleaning aids or have single-use items that are discarded after use. Cleaning cloths, brushes, sponges, mops, and similar cleaning aids can become contaminated with bacteria and then can spread the bacteria to every surface they contact. Therefore, they should be cleaned of visible material and soaked in clean sanitizer between uses. Retailers should monitor sanitizer strength and change the sanitizer as needed so that food particles do not overwhelm the effectiveness of the sanitizer.
• Use low water pressure when cleaning in the deli areas. Splashing and overspray from high-pressure hoses can aerosolize microorganisms and distribute them into the air and onto nearby surfaces.
• Use separate sinks for hand washing and cleaning product or equipment (as recommended by the 2013 Food Code (2-301.15 and 4-501.16)). Hand washing can cause the sink to be contaminated with Lm and other pathogens, which can be spread to any other items cleaned in the sink.
• Eliminate or remove unnecessary items (e.g., supplies and equipment) from the deli area. Organize supplies and equipment to facilitate thorough cleaning.

As stated on page 4, the Interagency Retail Lm Risk Assessment found that increasing the level of Lm and the potential of cross-contamination increases the predicted risk of listeriosis. The 2013 FDA Food Code (6-101.11(A)(1)) recommends that floors, walls, and ceilings be smooth, durable, and easily cleanable. Facilities, equipment, and utensils should not contribute to product adulteration or contamination. Here are some areas to check and some insanitary issues to avoid.

• Do not allow conditions in the retail facility that could cause the product to become adulterated. These conditions could include condensation dripping on exposed product, construction dust on product or food contact surfaces, or broken equipment which could harbor Lm.
• Ensure that walls, floors, drains, and overhead structures in the RTE deli and cooler areas are smooth, durable, easily cleanable, and in good repair. Rubber floor mats and other items used on the floor may be harborage sites for Lm. Clean them as often as necessary to ensure that sanitary conditions are maintained.
• Do not perform construction (e.g., replacing floors, walls, or ceilings) when exposed RTE product is present in the deli. Lm can be harbored behind the walls and carried by dust. Therefore, the product and equipment should be protected during construction, and the deli area should be cleaned and sanitized after construction and before use.
• Maintain tables, slicers, and other food contact surfaces so that they are easily cleanable. Rough surfaces created by welds, cracks, and other defects can be difficult to clean and can create areas where bacteria can hide. Replace worn, missing, or degraded seals or gaskets because they may become contaminated with Lm.
• Clean overhead structures as often as necessary to keep them free of condensation and ensure that sanitary conditions are maintained. Overhead items (e.g., cracked light fixtures) can be Lm harborage points. Condensation on overhead structures can lead to contamination of food or food preparation surfaces.
• Keep water from pooling on the floor or other surfaces within the deli area. Doing so will reduce the likelihood that splashes could contaminate food products or food contact surfaces. Standing water can serve as a vehicle for Lm and other pathogens.

As mentioned previously, the Interagency Retail Lm Risk Assessment found that wearing gloves while serving customers reduces the predicted risk of listeriosis. The 2013 FDA Food Code also recommends that employees wear gloves or use other suitable utensils to handle RTE foods and includes recommendations for training, hand washing, employee health and hygiene, and limiting public access in deli areas to prevent product contamination (references below). Good employee hygiene practices are critical to prevent cross-contamination and the spread of Lm and other pathogens. Lm can be present on, and spread by, equipment, materials, foods, and people. Here are a few employee practices retailers can use to minimize cross-contamination.

• Ensure that employees wear gloves or use suitable utensils when handling RTE products, as recommended by the 2013 FDA Food Code (3-301.11(B)). Provide disposable gloves so that employees wear and change gloves, as needed, to prevent the contamination of food.
  
  NOTE: The Interagency Retail Lm Risk Assessment found that employees not wearing gloves increases the predicted risk of listeriosis from the consumption of RTE products sliced or prepared in the retail deli department by approximately 5%.
• Train employees in sanitation practices and safe food handling procedures. Ensure that the manager has knowledge of food safety practices and procedures, as recommended by the 2013 FDA Food Code (2-102.11), and that employees have been properly trained in hygienic practices.
• Provide adequate facilities, including soap and running water, for employees to wash their hands. As recommended by the 2013 FDA Food Code (2-301.14), employees should wash hands prior to gloving, when switching between handling raw and RTE foods, after engaging in other activities that may contaminate the hands (e.g., handling money or potentially dirty or contaminated surfaces), or using the restroom.
• Implement a policy to ensure that ill employees do not work with open food items, including RTE foods. For example, written procedures should include removing workers from the deli when they are ill with respiratory or diarrheal diseases, as recommended by the 2013 FDA Food Code (2-201.11).
• Limit employee traffic in the deli area and develop traffic-flow plans for product, employees, and other items to prevent contamination by consumers and employees. The plans should minimize exposure of open RTE foods to raw foods, exterior packaging, and other possibly contaminated materials, such as boxes, trash, and chemicals. Designing facilities and controlling traffic in the deli area to restrict movement of people and material reduces the chance of cross-contamination. Non-deli workers should not handle exposed RTE products.
• Develop practices to prevent outer clothing from spreading contamination. Ensure that employees change their aprons or outer clothing, such as frocks or smocks, when the clothing is soiled with food or dirt particles that could transfer to food or food contact surfaces. Employees should not hold exposed RTE food products against their aprons or other clothing. Employees should not wear this outer clothing into restrooms, in break areas, or outside the deli area.

The information in this brochure is taken from FSIS Best Practices Guidance for Controlling Listeria monocytogenes (Lm) in Retail Delicatessens. These are suggestions and not requirements. Retailers should be aware that the recommendations in this guidance, especially those based on the 2013 Food Code may be requirements in State, local, or tribal regulations.

Best Practice Brochure

This tool covers steps that retail deli operators and their suppliers can take to help reduce the risk of listeriosis.

No single action or practice will control Lm contamination of retail foods. Instead there are many steps that retail deli operators and their suppliers can take to help reduce the risk of listeriosis. Retailers should use this tool to determine whether they have adopted the appropriate procedures to control Lm, or whether they should adopt new procedures. The preferred answer (based on the information in the guidance) is indicated with an asterisk. Having a "no" answer does not necessarily indicate lack of control. If retailers find that they are not meeting the recommendations in this guidance, they should consider changing practices to better control Lm in the deli area. This tool is also available in PDF format.

*Preferred answer

Lm is a bacterium that is found in moist environments, soil, and decaying vegetation and can persist along the food continuum.  Transfer of the bacteria from the environment (e.g., deli cases, slicers, and utensils), employees, or raw food products is a particular hazard of concern in RTE foods, including meat and poultry products.  Listeriosis is a serious infection usually caused by eating food contaminated with Lm.  Controlling Lm has long been an objective of the public health community.  The Centers for Disease Control and Prevention (CDC) estimates that infection with Lm causes about 1,600 illnesses, 1,500 hospitalizations, and 260 deaths in the United States each year.  Listeriosis is rare, but its fatality rate is very high (about 16 percent, compared with 0.5 percent for either Salmonella or E. coli O157:H7) (Scallan et. al., 2011).  It primarily affects older adults, pregnant women, newborns, and adults with weakened immune systems.

Note: The CDC estimates that Lm causes a high level of deaths compared to other foodborne pathogens. Deli products have been shown to be a major contributor to these illnesses. Retailers can help decrease the risk of illness by controlling Lm contamination in the deli.”

Lm can survive and grow at cool temperatures (as low as 34˚ F/1°C).  Because of its growth and survival characteristics, Lm is usually persistent in the environment and is commonly referred to as a harborage organism (i.e., it can form niches and grow to high numbers in the environment; niches provide an ideal place for Lm to establish and multiply).  It can cross-contaminate food contact surfaces and foods.  Improper sanitation, product handling, and employee practices can lead to the transfer of Lm to RTE meat and poultry products at retail causing them to become adulterated (see Regulation of Meat and Poultry Products at Retail below).

RTE meat and poultry products do not require cooking prior to being consumed and are often held at refrigerated temperatures.  Once contaminated with Lm, RTE food products may provide an ideal environment for this harmful bacterium to grow.  A variety of retail surveys of deli meats and a number of risk assessments of Lm in deli-sliced versus pre-packaged deli meats have analyzed the risk of listeriosis associated with deli prepared meat and poultry products.  The FSIS Comparative Risk Assessment for Lm in Ready-to-eat Meat and Poultry Deli Meats (May 2010) estimated that of listeriosis illnesses attributed to deli meat, 83% are associated with deli meat sliced and packaged at retail (Endrikat et al. 2010).

Safe food handling practices, thorough cleaning and sanitation procedures, maintenance of the facility and equipment, and good employee practices are key components that may prevent or reduce the likelihood of RTE foods becoming contaminated in retail delis.

FSIS shares jurisdiction with FDA and with State, local, and tribal authorities for meat and poultry products at retail. FDA makes recommendations regarding retail practices through the FDA Food Code. The Food Code is used by the State and local agencies as a model to establish regulations, ordinances, and actionable policies that can be enforced in their jurisdictions. Operators of retail establishments are required to comply with the conditions of the permit or license under which they operate.

The Federal Meat Inspection Act (FMIA) and Poultry Products Inspection Act (PPIA) apply to meat and poultry products produced in federally inspected establishments and other entities producing or handling meat and poultry, including at retail. Although retail firms are generally exempt from FSIS inspection, retailers are required to maintain sanitary conditions and otherwise not produce adulterated or misbranded product (21 U.S.C. 623(d) and 464(e); 9 CFR 303.1(f) and 381.10(d)(4)). The types of operations that are traditionally and usually conducted at retail stores can be found in 9 CFR 303.1(d)(1) and 9 CFR 381.10(d)(1).

FSIS provides instructions to its personnel for surveillance activities at retail in FSIS Directive 8010.1. The purpose of in-commerce surveillance is to ensure that FSIS-regulated meat and poultry products distributed in commerce are:

• Safe, wholesome, and not adulterated;
• Correctly marked, labeled, and packaged;
• Secure from intentional acts of contamination, and
• Legally imported and properly exported.

When performing in-commerce surveillance, FSIS verifies that:

• Meat and poultry are wholesome and not adulterated;
• Sanitary conditions are such that meat and poultry will not become contaminated with filth or rendered injurious to health;
• Hazard controls are adequate to prevent meat and poultry from becoming adulterated;
• Meat or poultry not intended for use as human food are properly denatured or otherwise made inedible as prescribed by Federal regulations; and
• All records are kept and maintained in a manner that fully and correctly discloses all transactions involved in the business activity that is subject to the provisions of the FMIA and PPIA.

This guidance does not replace the FDA Food Code, State, tribal or local, or FSIS regulations. This document can be used along with the 2013 FDA Food Code to help retailers ensure that meat and poultry products are not prepared or sliced under insanitary conditions in the retail deli area, which can lead to Lm contamination and outgrowth of the organism on the product.

The Interagency Retail Lm Risk Assessment was jointly developed by FSIS and FDA, and in consultation with the CDC, to help guide food safety efforts to minimize the public health burden of listeriosis in the U.S. The risk assessment was conducted to better understand how retail practices (e.g., temperature control, sanitation, worker behavior) influence the public health risk of listeriosis associated with eating deli products (e.g., meats, cheeses, and salads) sliced or prepared in retail. It also examines how effective various interventions are in limiting the survival, growth, or cross-contamination of Lm.

The risk assessment is based on observations of:

• Deli employees' work routines;
• Concentrations of Lm on incoming products and in the deli environment;
• Studies on the ability of Lm to spread in retail delis, such as from a slicer to food; and
• An existing dose-response model.

The study was designed to apply to a range of deli establishments, from small independent operations to the deli departments in large supermarkets.

The risk assessment also reinforces the importance of FDA's Food Code recommendations to operators of retail delis. State, local, and tribal jurisdictions can do their part to reduce listeriosis by enforcing all relevant provisions of the 2013 FDA Food Code as part of their own food safety requirements.

The risk assessment found that certain practices are needed to effectively prevent cross-contamination and limit Lm growth in RTE foods handled or prepared in retail delicatessens, including:

• Proper storage,
• Adequate sanitation, and
• Effective employee practices.

NOTE: This document includes key findings from the Interagency Retail Lm Risk Assessment and provides an overall summary of the data for typical retail deli settings. More detailed information regarding the findings is in the Retail Lm Risk Assessment Report.

If all refrigerated RTE foods are stored at 41°F (5°C) or below, as the 2013 FDA Food Code (3-501.16(A)(2)) recommends, approximately 9% of predicted listeriosis cases caused by contaminated deli products prepared or sliced in the retail deli could be prevented.

If all deli products that support Lm growth were reformulated to include growth inhibitors, approximately 96% of predicted listeriosis illnesses caused by RTE products prepared or sliced in the retail deli could be prevented. While this finding is significant, the actual benefit may be smaller in part because the concentration of the growth inhibitor used may not be sufficient to be effective throughout the shelf life of a food or may not be used in high enough concentrations because the inhibitors can adversely affect the flavor of the product.

The predicted risk of listeriosis dramatically increases in retail delis as a result of cross-contamination. In particular, slicers are key sources of cross-contamination in retail delis. Eliminating all points of cross-contamination in the deli (including slicers) would decrease the predicted risk of illness from the consumption of RTE products prepared or sliced in the retail deli by approximately 34%. Cross-contamination is particularly difficult to control completely; however, the risk assessment shows that proper product handling, cleaning, sanitizing, and glove use help prevent cross-contamination.

Increased levels of Lm from incoming products and the environment (including potential niches), directly increases the predicted risk of illness. Therefore, elimination of environmental niches in the deli area will reduce the predicted risk of listeriosis from the consumption of RTE products prepared or sliced in the retail deli. Additionally, if levels of Lm on RTE foods (including foods that do not support the growth of Lm) that the retail deli receives from processing establishments were reduced by half, approximately 22% of the predicted listeriosis illnesses caused by contaminated deli products could be prevented. This finding suggests that continued efforts to prevent low levels of Lm contamination during processing, even on products that do not support growth of the pathogen, reduces the predicted risk from these products and other RTE foods that can be subsequently cross-contaminated in the retail delis.

Sanitation practices that eliminate Lm from deli food-contact surfaces reduce the predicted risk of illness. Cleaning and sanitizing food-contact surfaces reduces the predicted Lm levels in the deli area. Employees not wearing gloves while serving customers increases the predicted risk of listeriosis from the consumption of RTE products prepared or sliced in the retail deli by approximately 5%.