CACIGL 61 - 2007 Page | of 28 GUIDELINES ON THE APPLICATION OF GENERAL PRINCIPLES OF FOOD HYGIENE TO THE CONTROL OF LISTERIA MONOCYTOGENES IN FOODS CAC/GL 61 - 2007 Table of Content INTRODUCTION. SECTION I - Objectives... SECTION IT = SCOPE ssn 2.1 Score... 2.2 DEFINITIONS... ssn SECTION TI - PRIMARY PRODUCTION nner 7 3.1 ENVIRONMENTAL HYGIENE: 7 3.2 HYGIENIC PRODUCTION OF Foo SOURCES... 7 3.3 HANDLING, STORAGE AND TRANSPORT. . 1 34.CLEANING, MAINTENANCE AND PERSONNEL HYGIENE AT PRIMARY PRODUCTION 7 SECTION IV - ESTABLISHMENT: DESIGN AND FACILITIES sss 7 4.1 LOCATION... 8 4.1.1 Establishments 8 4.1.2 Equipment. 8 4.2 PREMISES AND ROOMS ... 8 4.2.1 Design and Layout. 8 4.2.2 New construction/renovations, os os 8 4.23 Temporary/mobile premises and vending machines. “ “ so 8 8 8 9 9 9 9 9 9 9 9 9 9 9 4.3 EQUIPMENT... 43.1 General, 4.3.2 Food control and monitoring equipment... 4.3.3 Containers for waste and inedible substances. 4.4 FACILITIES 4.4.1 Water supply . 44.2 Drainage and waste disposal. 44.3 Cleaning 44.4 Personnel hygiene facilities and toilets... 44.5 Temperature control... 4.4.6 Air quality and ventilation. 44.7 Lighting 44.8 Storage SECTION V - CONTROL OF OPERATION. 5.1 CONTROL OF THE FOOD HAZARD... 5.2. KEY ASPECTS OF IIYGIENE CONTROL SYSTEMS 10 5.2.1 Time and temperature control. 10 5.2.2 Specific process steps. - 10 5.2.3 Microbiological and other specifications. . so u 5.2.4 Microbiological cross-contamination ulCACIGL 61 - 2007 Page 2 of 28 5.2.5 Physical and chemical contamination .. se se ul 5,3 INCOMING MATERIAL REQUIREMENTS., u 5.4 PACKAGING... es cnn senna UL 5.5 WATER wo oe en ssn nnn ul 5.5.1 In contact with food. . R 5.5.2.As an ingredient, 12 5.5.3 Ice and steam . se se . 12 5.6 MANAGEMENT AND SUPERVISION 12 5.7 DOCUMENTATION AND RECORDS 12 5.8 RECALL PROCEDURE enn so 12 5.9 MONITORING OF EFFECTIVENESS OF CONTROL MEASURES FOR L. MONOCYTOGENES, 2 SECTION VI - ESTABLISHMENT: MAINTENANCE AND SANITATION... R 6.1 MAINTENANCE AND CLEANIN sonnne sesnnnnnnnnnnnnnnnnnnnnnnne 1 6.11 General. “ os os “ B 6.1.2 Cleaning procedures and methods...» “ “ wo BB 6.2 CLEANING PROGRAMS vo 4 6.3 PEST CONTROL SYSTEMS 6... ssnnnnennnns ssn sess 14 6.3.1 Gener oor ssnnnnsnnnnesnnnnnennnn “ 6.3.2 Preventing access... : ssn “ “ Md 6.3.3 Harbourage and infestation i 6.3.4 Monitoring and detection i“ 6.3.5 Eradication - a “ 4 6.4 WASTE MANAGEMENT 14 6.5 MONITORING EFFECTIVENESS, SECTION VII-ESTABLISHMENT: PERSONAL HYGIENE 7.1 HEALTH STATUS. 7.2 ILLNESS AND INIURIES Is 7.3 PERSONAL CLEANLINESS vss ese . secs 15 7.4 PERSONAL BEHAVIOUR. ..ssssnsnnsnnnnnnnnnnnnnnnninnssnnnnnnnnnnnnnnnennnnns ES 14 met Is 7.5 Visitors wu IS SECTION VIII - TRANSPORTATION. 15 8.1 GENERAL 15 8,2 REQUIREMENTS... seeennnnnnnnnee 1S 8.3 USE AND MAINTENANCE .snnnnnnnnnnnnnninnnnnnnnnnnisisinnnnnnnnnnnininininnnssetee 16 SECTION IX - PRODUCT INFORMATION AND CONSUMER AWARENESS 16 9.1 LOT IDENTIFICATION... 16 9.2 PRODUCT INFORMATION... 16 9.3 LABELLING ... . 16 9.4 CONSUMER EDUCATION 16 SECTION X - TRAINING .. 7 10.1 AWARENESS AND RESPONSIBILITIES .. 7 10.2 TRAINING PROGRAMS .. 10.3 INSTRUCTION AND SUPERVISION 10.4 REFRESHER TRAINING 7 17 7CACIGL 61 - 2007 Page 3 of 28 ANNEX I: RECOMMENDATIONS FOR AN ENVIRONMENTAL MONITORING PROGRAM FOR LISTERIA MONOCYTOGENES IN PROCESSING AREAS osnnsnnenonnnnnnnnnnnnnmnnnnnesne 18 ANNEX II: MICROBIOLOGICAL CRITERIA FOR LISTERIA MONOCYTOGENES IN READY-TO-EAT Foops 21 ANNEX Ill: RECOMMENDATIONS FOR THE USE OF MICROBIOLOGICAL TESTING FOR ENVIRONMENTAL MONITORING AND PROCESS CONTROL VERIFICATION BY COMPETENT AUTHORITIES AS A MEANS OF VERIFYING THE EFFECTIVENESS OF HACCP AND PREREQUISITE PROGRAMS FOR CONTROL OF LISTERIA MONOCYTOGENES IN READY-TO-EAT FOODS 27CACIGL 61 - 2007 Page 4 of 28 INTRODUCTION Listeria (L.) monocytogenes is a Gram-positive bacterium that occurs widely in both agricultural (soil, vegetation, silage, faecal material, sewage, water), aquacultural, and food processing environments. L. monocytogenes isa transitory resident of the intestinal tract in humans, with 2 to 10% of the general population being carriers of the microorganism without any apparent health consequences.’ In comparison to other non-spore forming, foodborne pathogenic bacteria (e.g., Salmonella spp., enterohemorthagic Escherichia coli), L. monocytogenes is resistant to various environmental conditions such as high salt or acidity. L. monocytogenes grows at low oxygen conditions and refrigeration temperatures, and survives for ong periods in the environment, on foods, in the processing plant, and in the household refrigerator. Although frequently present in raw foods of both plant and animal origin, sporadic cases or outbreaks of listeriosis are generally associated with ready-to-eat, refrigerated foods, and often involves the post- processing recontamination of cooked foods. L, monocytogenes has been isolated from foods such as raw vegetables, raw and pasteurised fluid milk, cheeses (particularly soft-ripened varieties), ice cream, butter, fermented raw-meat sausages, raw and cooked poultry, raw and processed meats (all types) and raw, preserved and smoked fish. Even when L, monocytogenes is initially present at a low level in a contaminated food, the microorganism may multiply during storage in foods that support growth, even at reftigeration temperatures. L, monocytogenes causes invasive listeriosis wherein the microorganism penetrates the lining of the gastrointestinal tract and then establishes infections in normally sterile sites within the body. The likelihood that L. monocytogenes can establish a systemic infection is dependent on a number of factors, including the number of microorganisms consumed, host susceptibility, and virulence of the specific isolate ingested Almost all strains of L. monocytogenes appear to be pathogenic though their virulence, as defined in animal studies, varies substantially, Listeriosis is an infection that most often affects individuals experiencing immunosuppression including individuals with chronic disease (e.g., cancer, diabetes, malnutrition, AIDS), foetuses ot neonates (assumed to be infected in utero), the elderly and individuals being treated with immunosuppressive drugs (¢.g., transplant patients). ‘The bacterium most often affects the pregnant uterus, the central nervous system or the bloodstream. Manifestations of listeriosis include but are not limited to bacteremia, septicaemia, meningitis, encephalitis, miscarriage, neonatal disease, premature birth, and stillbirth. Incubation periods prior to individuals becoming symptomatic can be from a few days up to three months, L, monocytogenes can also cause mild febrile gastro-enteritis in otherwise healthy individuals. The public health significance of this type of listeriosis appears to be much lower than that of invasive listeriosis. Available epidemiological data show invasive listeriosis occurs both as sporadic cases and outbreaks, with the former accounting for the majority of cases. Invasive listeriosis is a relatively rare, but often severe disease with incidences typically of 3 to 8 cases per 1,000,000 individuals and fatality rates of 20 to 30% among hospitalised patients.” During recent years, the incidence of listeriosis in most countries has remained constant, with a number of countries reporting declines in the incidence of disease. These reductions likely reflect the efforts in those countries by industry and governments (a) to implement Good Hygienic Practice (GHP) and apply HACCP to reduce the frequency and extent of L. monocytogenes in ready-to-eat foods, (b) to improve the integrity of the cold chain through processing, distribution, retail and the home to reduce the incidence of temperature abuse conditions that foster the growth of L. monocytogenes, and (c) to enhance risk communication, particularly for consumers at increased risk of listeriosis. However, further actions are needed to achieve continuous improvement of public health by lowering the incidence of human foodborne listeriosis worldwide. Periodically transitory increases in incidence have been noted in several countries These have been associated typically with foodbome outbreaks attributable to specific foods, often from specific manufacturers. In such cases, the incidence of listeriosis returned to prior baseline values after the causative food was removed from the market, and consumers received effective public health information pertaining to appropriate food choices and handling practices. FAO (2000): Joint FAO/WHO Expert Consultation on Risk Assessment of Microbiological Hazards in Foods. FAO, Food and Nuttition Paper No. 71 FAO and WHO (2001): Joint FAO/WHO Expert Consultation on Risk Assessment of Microbiological Hazards in Foods: Risk characterisation of Salmonella spp. in eggs and broiler chickens and L. monocytogenes in ready- to-cat foods, FAO, Food and Nutrition Paper No.72.CACIGL 61 - 2007 Page 5 of 28 Listeriosis has been recognised as a human disease since the 1930's, however, it was not until the 1980’s, when there were several large outbreaks in North America and Europe, that the role that foods play in the transmission of the disease was fully recognised. Foods are now considered to be the major vehicle for L. monocytogenes. A variety of specific foods have been implicated in outbreaks and sporadic cases of listeriosis (¢.g., processed meats, soft cheeses, smoked fish, butter, milk, coleslaw). The foods associated with listeriosis have been overwhelmingly ready-to-eat products that are typically held for extended periods at reftigeration or chill temperatures. ‘The large number of ready-to-eat foods in which L. monocytogenes is at least occasionally isolated has made it difficult to effectively focus food control programs on those specific foods that contribute the greatest risk to foodborne listeriosis. As a means of addressing this and a number of related questions, several formal quantitative risk assessments have been undertaken to address issues related to the relative risks among different ready-to-eat foods and the factors that contribute to those risks. Available governmental risk assessments currently include (1) a comparative risk assessment of 23 categories of ready-to-eat foods conducted by the U.S. Food and Drug Administration and the Food Safety and Inspection Service (FDAVFSIS, 2003)", (2) a comparative risk assessment of four ready-to-eat foods conducted by FAO/WHO JEMRA at the request of the Codex Committee on Food Hygiene‘, and (3) a product/process pathway analysis conducted by the U.S. Food Safety and Inspection Service for processed meats’, which examined the risk of product contamination from food contact surfaces. Each of these assessments articulates concepts that countries can use to identify and categorise those ready- to-cat products that represent a significant risk of foodborne listeriosis. Five key factors were identified as contributing strongly to the risk of listeriosis associated with ready-to-eat foods: ‘+ Amount and frequency of consumption of a food ‘+ Frequency and extent of contamination of a food with L. monocytogenes ‘+ Ability of the food to support the growth of L. monocytogenes ‘+ Temperature of refrigerated/chilled food storage ‘+ Duration of refrigerated/chilled storage ‘A combination of interventions intervention (FDA/FSIS, 2003)". is generally more effective in controlling the risk rather than any single In addition to the factors above, which influence the number of L. monocytogenes present in the food at the time of consumption, the susceptibility of an individual is important in determining the likelihood of listeriosis. The risk assessments that have been conducted have consistently identified the impact that the ability of a food to support the growth of L. monocytogenes has on the risk of listeriosis. Those foods that are able to support growth during the normal shelf life of a product increase substantially the risk that the food will contribute to foodborne listeriosis. Control of growth can be achieved by several different approaches, including reformulation of the product such that one or more of the parameters influencing the growth of the bacterium (e.g., pH, water activity, presence of inhibitory compounds) is altered so the food no longer supports growth, Alternatively, strict control of temperature so that ready-to-eat foods never exceed 6°C (preferably 2°C- 4°C) and/or shortening the duration of the product refrigerated/chilled shelf life are other ‘means for assuring that growth to any significant degree does not occur before the product is consumed, FDAVFSIS, 2003. Quantitative assessment of the relative risk to public health from foodborne Listeria _monocytogenes among selected categories of ready-to-eat foods. at yww.cfSan.fdazov FAOMWHO, 2004. Risk assessment of Listeria monocytogenes in ready-to-eat foods. Technical Report. Microbiological Risk Assessment Series, No, 5 FSIS Rule Designed to Reduce Listeria monocytogenes in Ready-to-Bat Meat & Poultry at htp://www-feis.usda.gov/factsheets/fsis_rule_designed_to_reduce_listerialindex.aspCACIGL 61 - 2007 Page 6 of 28 Many of the ready-to-eat products that are associated with foodbome listeriosis include a step in their production that is listericidal. Thus, the frequency and level of contamination of these products with L. monocytogenes is typically associated with the recontamination of the product prior to final packaging or from subsequent handling during marketing or home use. Thus, another strategy to control foodborne listeriosis is to reduce recontamination of the product and/or to introduce an additional mitigation treatment after final packaging. Control of the frequency and level of contamination is likely to be influenced strongly by factors such as attention to the design and maintenance of equipment and the integrity of the cold chain, the latter clearly being identified as a risk factor (ie, the temperature of refrigerated/chilled storage), Some ready-to-eat foods do not include a listericidal treatment. Product safety in those instances is dependent on steps taken during primary production, processing, and subsequent distribution and use to minimise or reduce contamination/recontamination and to limit growth through maintaining the cold chain and limiting the duration of refrigerated storage The FAO/WHO tisk assessment also clearly indicated that in order for food control programmes to be effective, they must be capable of consistently achieving the degree of control required; the risk of listeriosis is largely associated with failures to meet current standards for L. monocytogenes, be they at 0.04 or 100 CFU/g. The analyses conducted within that risk assessment clearly indicate that the greatest risk associated y-to-eat products is the small portion of the products with high contamination levels of ogenes. Thus, a key component of a successful risk management program is assurance that control measures (e.g., preventing contamination and growth of the pathogen) can be achieved consistently. SECTION I - OBJECTIVES These guidelines provide advice to governments on a framework for the control of L. monocytogenes in ready-to-eat foods, with a view towards protecting the health of consumers and ensuring fair practices in food trade. Their primary purpose of these guidelines is to minimise the likelihood of illness arising from the c of L. monocytogenes in ready-to-eat foods. ‘The guidelines also provide information that will be of to the food industry, consumers, and other interested partes. SECTION II - SCOPE 2.1 Score. These guidelines are intended for ready-to-eat foods and are applicable throughout the food chain, from primary production through consumption. However, based on the results of the FAO/WHO risk assessment, other available risk assessments and epidemiological evaluations, these guidelines will focus on control ‘measures that can be used, where appropriate, to minimize and/or prevent the contamination and/or the growth of L. monocytogenes in ready-to-eat foods. ‘These guidelines highlight key control measures that affect key factors that influence the frequency and extent of contamination of ready-to-eat foods with L, monocytogenes and thus the risk of listeriosis. In many instances, these control measures are articulated in a general manner in the Recommended International Code of Practice - General Principles of Food Hygiene (CACIRCP 1-1969) as part of the general strategy for control of foodbome pathogens in all foods. In providing these guidelines, it is assumed that these General Principles of Food Hygiene are being implemented. ‘Those principles that are restated reflect the need for special attention for the control of L, monocytogenes. Good Hygienic Practices (GHPs) as specified in the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969) and other applicable codes of hygienic practice should be suitable to control L. monocytogenes in non ready-to-eat foods. However, the additional measures described in the following guidelines should be consulted and implemented, as necessary to control L. monocytogenes in ready-to-eat foods. 2.2 DEFINITIONS For the purpose of these Guidelines, the following definitions apply: Definitions of the “Principles and Guidelines for the Conduct of Microbiological Risk Management” apply Ready-to-eat food — Any food which is normally eaten in its raw state or any food handled, processed, mixed, cooked, or otherwise prepared into a form which is normally eaten without further listericidal steps.CACIGL 61 - 2007 Page 7 of 28 SECTION III - PRIMARY PRODUCTION Many ready-to-eat foods receive one or more treatments during processing or preparation that inactivate or inhibit the growth of L. monocytogenes. For these foods animal health and general application of good agricultural practices, including animal husbandry, should be sufficient to minimise the prevalence of L. monocytogenes at primary production, In those ready-to-eat foods that are manufactured without a listericidal treatment, extra attention at primary production is needed to assure specific control of the pathogen (e.g., control of L. monocytogenes mastitis in dairy cattle and sheep where the milk will be used to make raw milk cheeses, frequency of L. monocytogenes in raw milk as related to the feeding of inadequately fermented silage, high levels of L. monocytogenes in pork for fermented sausages resulting from wet feeding systems, faecal contamination of fresh produce), including increased focus on personal hygiene and water management programs at the primary production sites. Analysis of raw material for Z. monocytogenes can be, where appropriate, an important tool for validating and verifying that the control measures at the primary production level are adequately limiting the frequency and level of contamination to that needed to achieve the required level of control during subsequent ‘manufacturing 3.1 ENVIRONMENTAL HYG! cE Refer to the Recommended International Code of Practice - General Prine’ 1-1969). les of Food Hygiene (CACIRCP. 3.2 HYGIENIC PRODUCTION OF FOOD SOURCES Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969), 3.3 HANDLING, STORAGE AND TRANSPORT Refer to the Recommended Intemational Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 3.4. CLEANING, MAINTENANCE AND PERSONNEL HYGIENE AT PRIMARY PRODUCTION Refer to the Recommended International C 1-1969). SECTION IV - ESTABLISHMENT: DESIGN AND FACILITIES \de of Practice - General Principles of Food Hygiene (CAC/RCP. Objectives: Equipment and facilities should be designed, constructed and laid out to ensure cleanability and to minimise the potential for L. monocytogenes harbourage sites, cross-contamination and recontamination. Rationale: The introduction of L. monocytogenes into the ready-to-eat processing environment has resulted from inadequate separation of raw and finished product areas and from poor control of employees or equipment traffic = Inability to properly clean and disinfect equipment and premises due to poor layout or design and areas inaccessible to cleaning has resulted in biofilms containing L. monocytogenes and harbourage sites that have been a source of product contamination = The use of spray cleaning procedures that aerosolize the microorganism has been linked to the spread of the L. monocytogenes in the processing environment, = Inability to properly control ventilation to minimise condensate formation on surfaces in food processing plants may result in the occurrence of L. monocytogenes in droplets and acrosols which can lead to product contamination,CACIGL 61 - 2007 Page 8 of 28 4.1 LOCATION 4.1.1 Establishments Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 4.1.2 Equipment Whenever possible, equipment should be designed and placed in a manner that facilitates access for efficient cleaning and disinfection, and thus avoid the formation of biofilms containing L. monocytogenes and harbourage sites. 4.2 PREMISES AND RooMS 4.2.1 Design and Layout Whenever feasible, premises and rooms should be designed to separate raw and finished ready-to-eat product areas. This can be accomplished in a number of ways, including linear product flow (raw to finished) with filtered airflow in the opposite direction (finished to raw) or physical partitions. Positive air pressure should be maintained on the finished side of the operation relative to the “raw” side (e.g., maintain lower air pressures in raw areas and higher pressures in finished areas). Where feasible, the washing areas for food equipment involved in the manufacture of the finished product should be located in a separate room from the finished product processing area. This latter area should be separate from the raw ingredient handling area and the cleaning area for equipment used in the handling of raw ingredients in order to prevent recontamination of equipment and utensils used for finished products Rooms where ready-to-eat products are exposed to the environment should be designed so that they can be ‘maintained as dry as possible; wet operations often enhance the growth and spread of L. monocytogenes, 4.2.2 New construction/renovations Due to the ability of L. monocytogenes to survive in the plant environment for long periods of time, disturbances caused by construction or modification of layouts can cause reintroduction of L. monocytogenes from harbourage sites to the environment. Where appropriate, care should be taken to isolate the construction area, to enhance hygienic operations and to increase environmental monitoring to detect Listeria spp. during construction/renovation (see Section 6.5) 4.2.3 Temporary/mobile premises and vending machines Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 4.3 EQUIPMENT 4.3.1 General Due to the ability of L. monocytogenes to exist in biofilms and persist in harbourage sites for extended periods, processing equipment should be designed, constructed and maintained to avoid, for example, cracks, crevices, rough welds, hollow tubes and supports, close fitting metal-to-metal or metal-to-plastic surfaces, worn seals and gaskets or other areas that cannot be reached during normal cleaning and disinfection of food contact surfaces and adjacent areas. Racks or other equipment used for transporting exposed product should have easily cleaned cover guards over the wheels to prevent contamination of the food from wheel spray. Cold surfaces (e.g., refrigeration units) can be sources for psychrotrophic bacteria, especially L, monocytogenes. Condensate from refrigeration unit pans should be directed to a drain via a hose or drip pans should be emptied, cleaned and disinfected on a regular basis. Insulation should be designed and installed in a manner that it does not become a harbourage s L. monocytogenesCACIGL 61 - 2007 Page 9 of 28 4.3.2 Food control and monitoring equipment Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 4.3.3 Containers for waste and inedible substances Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 4.4 FACILITIES 4.4.1 Water supply Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 4.4.2 Drainage and waste disposal Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 4.4.3 Cleaning Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969),. 4.4.4 Personnel hygiene facilities and toilets Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 4.4.5 Temperature control Refer to the Recommended Intemational Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 4.4.6 Air quality and ventilation Control of ventilation to minimise condensate formation is of particular importance in L. monocytogenes control, since the organism has been isolated from a wide variety of surfaces in food processing plants Wherever feasible, facilities should be designed so that droplets and aerosols from condensates do not directly or indirectly contaminate food and food contact surfaces, 4.4.7 Lighting Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 4.4.8 Storage Where feasible and appropriate for the food product, and where food ingredients and products support growth of L, monocytogenes, storage rooms should be designed so that a product temperature should not exceed 6°C, (preferably 2°C - 4°C). Raw materials should be stored separately from finished, processed produets. SECTION V - CONTROL OF OPERATION Objectives: Processing operations should be controlled to reduce the frequency and level of contamination in the finished product, to minimise the growth of L. monocytogenes in the finished product and to reduce the likelihood that the product will be recontaminated and/or will support the growth of L. monocytogenes during subsequent distribution, marketing and home use.CACIGL 61 - 2007 Page 10 of 28 Rationale: For many ready-to-cat products listericidal processes* can ensure appropriate reduction in risk. However, not all ready-to-eat products receive such a treatment and other ready-to-eat products may be exposed to the environment and thus may be subject to potential recontamination. Prevention of cross-contamination, strict control of time and temperature for products in which Z. monocytogenes can grow and formulation of products with hurdles to L. monocytogenes growth can minimise the risk of listeriosis. 5.1 CONTROL OF THE FOOD HAZARD Control of L. monocytogenes for many ready-to-eat products will typically require a stringent application of Good Hygienic Practice and other supportive programs, ‘These prerequisite programs, together with HACCP provide a successful framework for the control of L. monocytogenes. ‘The factors and attributes described below are components of Good Hygienic Practice programs that will typically require elevated attention to control L. monocytogenes and may be identified as critical control points in HACCP programs where L. monocytogenes is identified as @ hazard. 5.2 KEY ASPECTS OF HYGIENE CONTROL SYSTEMS 5.2.1 Time and temperature control The risk assessments done by the U.S. FDA/FSIS and FAO/WHO on L. monocytogenes in ready-to-eat foods demonstrated the tremendous influence of storage temperature on the risk of listeriosis associated with ready-to-cat foods that support L. monocytogenes growth. It is therefore necessary to control the time/temperature combination used for storage. Monitoring and controlling refrigerated storage temperatures are key control measures. The product temperature should not exceed 6°C (preferably 2°C - 4°C), Temperature abuse that may occur supporting the growth of L, monocytogenes could result in a reduction of product shelf lif. ‘The length of the shelf-life is another important factor contributing to the risk associated with foods that support L. monocytogenes growth. The shelf-life of such foods should be consistent with the need to control the growth of L. monocytogenes. Since L. monocytogenes is able to grow under refrigeration temperatures, the length of the shelf-life should be based on appropriate studies that assess the growth of L. monocytogenes in the food. Shelflife studies and other information are important tools facilitating the selection of the length of shelf-life. If they are conducted, they should account for the fact that appropriate low temperatures ‘may not be maintained throughout the entire food chain until the point of consumption. Temperature abuses may allow the growth of L. monocytogenes, if present, unless appropriate intrinsic factors are applied to prevent such growth. This should be taken into account when establishing shelf life. 5.2.2 Specific process steps Listericidal processes should be validated to ensure that the treatments are effective and can be applied consistently (see Section V of the Recommended Intemational Code of Practice - General Principles of Food Hygiene (CACIRCP 1-1969).. In some products single parameters, such as a pH less than 4.4, a water activity less than 0.92 or freezing, may be relied upon to prevent L. monocytogenes growth. In other products a combination of parameters is used. Validation should be undertaken to ensure the effectiveness of these parameters in situations where combinations of parameters ot bacteriostatic conditions are relied upon. Products supporting the growth of L. monocytogenes that have undergone a listericidal treatment may be contaminated/tecontaminated before final packaging. In these cases, additional control measures may be applied if necessary, (e.g., freezing the product, shortening the shelf life, reformulation of the product) to limit the extent of or prevent L. monocytogenes growth. Altematively, a post-packaging. listericidal treatment may be necessary ( e.g. heating, high pressure treatment, irradiation, where accepted). ‘Any appropriate treatment that kills listeria,CACIGL 61 - 2007 Page 11 of 28 In raw, ready-to-eat food (e.g. lettuce), that support the growth of L. monocytogenes, that may be contaminated, specific control measures may be applied if necessary to limit the extent of or prevent the growth of L. monocytogenes (e.g. acid wash). 5.2.3 Microbiological and other specifications Refer to the RecommendedInternational Code of Practice-General Principles of Food Hygiene(CAC/RCP 1- 1969) and Principles for the Establishment and Application of Microbiological Criteria for Foods (CAC/GL 21-1979) 5.2.4 Microbiological cross-contamination Microbiological cross-contamination is a major issue with respect to L. monocytogenes. It ean occur through direct contact with raw materials, personnel, aerosols and contaminated utensils, equipment, etc... Cross- contamination can occur at any step where the product is exposed to the environment, including processing, transportation, retail, catering, and in the home. Traffic flow pattems for employees, food products, and equipment should be controlled between raw processing, storage area(s) and finished area(s) to minimise the transfer of L. monocytogenes. For example, a change of footwear or automated foam sprayers can be an effective alternative to footbaths where people, carts, forklifts and other portable equipment must enter an area where ready-to-eat foods are exposed, Another example is to use a colour coding system to identify personnel assigned to specific areas of the plant. Utensils, pallets, carts, forklifts and mobile racks should be dedicated for use in either the raw area or the finished product area to minimise cross-contamination, Where this is not practical, they should be cleaned and disinfected before entry into the finished product area. Reused brines and recycled process water used in direct contact with finished product should be discarded or decontaminated (¢.g. chlorination for recycled water, heat treatment, or some other effective treatment) with sulficient frequency to ensure control of L. monocytogenes. Ready-to eat foods that do not support the growth of L. monocytogenes but may have low levels of this pathogen should not be a source of contamination to other ready-to-eat foods that may support the growth of this pathogen, Consideration should be given to the fact that some ready-to-eat foods with special handling requirements (for example ice cream), that are handled after opening may present a lower risk for being a vector for cross contaminating other ready-to-eat foods, because such specially handled product is rapidly consumed. Other ready-to-eat products, however, with special formulation (for example dry fermented sausage), that are handled after opening may present a higher risk of being a vector for cross contaminating other ready-to-eat products if neither ready-to-eat product is rapidly consumed. 5.2.5 Physical and chemical contamination Refer to the Recommended Intemational Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 5.3 INCOMING MATERIAL REQUIREMENTS Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 5.4 PACKAGING Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969), 5.5 WATER Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-196).CACIGL 61 - 2007 Page 12 of 28 5.5.1 In contact with food Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 5.5.2 As an ingredient Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 5.5.3 Ice and steam Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969), 5.6 MANAGEMENT AND SUPERVISION Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 5.7 DOCUMENTATION AND RECORDS Refer to the Recommended International Code of Practice - General Principles of Food Hygiene (CAC/RCP 1-1969). 5.8 RECALL PROCEDURES Based on the determined level of risk associated with the presence of L. monocytogenes in a given food product, a decision may be taken to recall the contaminated product from the market. In some instances, the need for public warnings should be considered. 5.9 MONITORING OF EFFECTIVENESS OF CONTROL MEASURES FOR L. MONOCYTOGENES An effective environmental monitoring program is an essential component of a Listeria control program, particularly in establishments that produce ready-to-eat foods that support growth and may contain L. monocytogenes. Testing of food products can be another component of verification that control measures for L. monocytogenes are effective (see Section 5.2.3), Recommendations for the design of an environmental monitoring program for L. monocytogenes in processing areas are given in Annex 1 SECTION VI - ESTABLISHMENT: MAINTENANCE AND SANITATION Objectives To provide specific guidance on how preventive maintenance and sanitation procedures, along with an effective environmental monitoring program can reduce contamination of food with L. monocytogenes, particularly when the foods support growth of L. monocytogenes: Well structured cleaning and disinfection procedures should be targeted against L. monocytogenes in food processing areas where ready-to-eat foods are exposed to reduce ‘+ the likelihood that the product will be contaminated after processing, ‘+ the level of contamination in the finished product. Rationale: Basic cleaning and disinfection programs are critical to assuring control of L. monocytogenes. An environmental monitoring program for Listeria in processing areas where ready-to-eat foods are exposed is necessary to assess the effectiveness of control measures and, therefore, the likelihood of contamination of the food.