Guidelines for Assessing the Microbiological Safety of Ready-to-Eat Foods Placed on the Market
Guidelines for Assessing the Microbiological Safetyof Ready-to-Eat Foods Placed on the Market
Authorship
These guidelines for assessing the microbiologicalsafety of ready-to-eat foods have been revised andwritten by a Health Protection Agency Working Groupand chaired by Professor Eric Bolton.
Working Group members • Professor Eric Bolton (Chair)
HPA Regional Microbiology Network• Dr Christine Little (Secretariat)
HPA Centre for Infections• Dr Heather Aird
HPA Regional Microbiology Network• Ms Melody Greenwood
Microtech Services (Wessex) Ltd• Dr Jim McLauchlin
HPA Regional Microbiology Network• Dr Richard Meldrum
NPHS Wales• Dr Susanne Surman-Lee
HPA Regional Microbiology Network• Dr Grahame Tebbutt
HPA Regional Microbiology Network• Dr Kathie Grant
HPA Centre for Infections
AcknowledgementsDrs Robert Mitchell and Satnam Sagoo (HPA Centre forInfections) for their contribution at an earlier time tothe revision of these guidelines.
Further informationFor further information on these guidelines, pleasecontact Dr Jim McLauchlin, HPA Regional MicrobiologyNetwork,e-mail: [email protected] [email protected]
CitationHealth Protection Agency. Guidelines for Assessing theMicrobiological Safety of Ready-to-Eat Foods. London:Health Protection Agency, November 2009.
Abbreviations
ACC Aerobic colony countBRC British Retail ConsortiumCFA Chilled Food Associationcfu/g Colony forming units per gramEC European CommissionEN European NormEU European UnionFBO Food business operatorFSA Food Standards Agencyg GramGHP Good hygiene practiceHACCP Hazard analysis and critical control point HPA Health Protection AgencyHUS Haemolytic uraemic syndromeIBS Irritable bowel syndromeISO International Organization for StandardizationKg KilogramLACORS Local Authorities Co-ordinators
of Regulatory ServicesMAP Modified atmosphere packagingMg MilligramMPN Most probable numberNPHS National Public Health Service for WalesTTP Thrombotic thrombocytopaenic purpuraUHT Ultra high temperatureUK United KingdomVT VerocytotoxinVTEC Verocytotoxin-producing Escherichia coliYrs Years
Table of contents
Section 1. Introduction 41.1 Purpose of the guidelines 41.2 Scope of the guidelines 41.3 Intended use of the guidelines 41.4 Commission Regulation on microbiological criteria for foodstuffs 5
Section 2 Pathogens 62.1 Introduction 62.2 Detection of pathogenic micro-organisms in ready-to-eat food 62.2.1 Campylobacter species (thermotolerant) 62.2.2 Escherichia coli O157 and other verocytotoxin-producing E. coli (VTEC) 62.2.3 Salmonella species 62.2.4 Shigella species 62.2.5 Vibrio cholerae 72.3 Enumeration of pathogenic micro-organisms in ready-to-eat food 72.3.1 Bacillus cereus 82.3.2 Bacillus species (other pathogenic Bacillus) 82.3.3 Clostridium perfringens 82.3.4 Listeria monocytogenes 82.3.5 Staphylococcus aureus and other coagulase-positive staphylococci 92.3.6 Vibrio parahaemolyticus 102.4 Foodborne pathogens and risk of disease 102.5 Specialist and reference tests 10
Section 3 Hygiene Indicator Organisms 123.1 Introduction 123.2 Enterobacteriaceae 123.3 Escherichia coli 123.4 Listeria species 12
Section 4 Aerobic Colony Counts 144.1 Introduction 144.2 ACC levels in various ready-to-eat foods 14
Section 5 Supplementary Advice on Use of the Guidelines 155.1 Microbiological methodology 155.2 Environmental samples 16
Section 6 Tables 16Table 1 Guidance on the interpretation of results for detection of bacterial pathogens
(the hazard) in ready-to-eat foods placed on the market 17Table 2 Guidance on the interpretation of results for enumeration of bacterial pathogens (the hazard)
in ready-to-eat foods placed on the market 18Table 3 Major features of foodborne diseases due to selected pathogens 22Table 4 Guidance on the interpretation of results for hygiene indicator organisms in ready-to-eat
foods placed on the market 24Table 5 Guidance on the interpretation of results for aerobic colony count levels in various ready-to-eat
foods and components placed on the market 26
Glossary 28
References 30
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SECTION 1
Introduction
1.1 Purpose of the guidelines In pursuit of the Health Protection Agency’s (HPA) goal ofpreventing and reducing the incidence and consequencesof infection1, the HPA examines foods from Local and PortHealth Authorities to help safeguard consumer health.These foods include samples submitted for surveillanceand monitoring, for official control purposes, and thosetested as part of outbreak investigations. From this workthe HPA has accumulated a wealth of data both on themicrobiological results and, crucially, on theirinterpretation. This information was captured andpromulgated in three previous sets of these guidelines2-4
for practical use by Food Examiners and Local AuthorityEnforcement Officers. These revised guidelines supersedethose previously issued and have a different emphasisfocusing on public health and consumer protection.Additional information on the bacteria that causefoodborne disease and those that act as hygieneindicators, on interpretation of test results, comments onpoor practices that are likely to have contributed toadverse results and suggested appropriate public healthactions, are now included.
The use of microbiological criteria as risk managementtools should only be applied when they can be shown tobe effective and can contribute to the provision of safeproducts5-7. Microbiological testing alone cannotguarantee the safety of food and microbiological criteriashould be used to support Good Hygienic Practice (GHP)and Hazard Analysis and Critical Control Point (HACCP)systems. The food industry has a duty to ensure thatmicro-organisms are eliminated or minimized to the extentthat they cannot cause harm to human health8, andofficial controls are in place to audit compliance by foodbusiness operators (FBOs)9.
1.2 Scope of the guidelines Food within the scope of the revised guidelines includesready-to-eat food sampled within the retail chain, e.g.retail, wholesale, distribution and food service sectors (asdefined by Regulation (EC) No. 178/200210). This includesfood components, such as herbs and spices, where theyare added to foods without further cooking or processing.The guidelines for pathogens also apply to food poisoninginvestigations in all settings including domesticenvironments. Criteria are also applied for bacteria thatindicate possible poor hygiene and/or substandardpractices. In some circumstances these guidelines may alsobe used to assess more fully the safety and quality of foodtaken from the producer’s premises. Although potablewater is now defined as food this matrix is not addressed
in these guidelines as there is relevant legislation andguidance that covers this commodity11-14. For some ready-to-eat foods (sampled from production and/or onthe market) statutory criteria exist and these food safety orprocess hygiene criteria are laid down in Regulation (EC)No. 2073/2005 (as amended) including sampling plans,analytical methods, and corrective actions15,16.
Local Authorities and Port Health Authorities areresponsible for food safety checks on imported foods atpoints of entry (e.g. Border Inspection Posts and otherdesignated Points of Entry). The revised guidelines alsoapply to ready-to-eat imported food, including both thosesourced from within the European Union (EU) as well asfrom countries outside of the EU.
These guidelines do not take precedence overmicrobiological criteria within European or nationallegislation (see section 1.4) but serve to complementlegally enforceable standards and provide an indication ofthe microbiological safety for foods where standardscurrently do not exist. Investigative action is required toidentify and rectify the cause for those foodstuffs notcompliant with microbiological food safety criteria and/orwhere there is a perceived risk to public health. Theseguidelines should therefore not be used to interpret theresults of microbiological parameters which are part ofstatutory regulations. To safeguard public health, however,additional tests on ready-to-eat foods not covered by theregulations may be considered appropriate. Food samplestaken at producer premises as part of inspections by localenforcement officers would be expected to givesatisfactory results for all parameters and any deviationshould be investigated.
1.3 Intended use of the guidelines These guidelines are for use by Food Examiners andenforcement officers in identifying situations requiringinvestigation for public health or food safety reasons, andare applicable to the following types of samples:• Samples collected during predefined sampling
programmes such as the Local Authorities Co-ordinatorsof Regulatory Services (LACORS)/HPA national microbiological food studies17;
• Samples taken at or during food inspections;• Samples taken to confirm previous adverse findings in
order to determine the scale of microbiological contamination;
• Samples collected during investigations of suspected outbreaks of disease;
• Samples submitted after complaints.
All of the types of samples listed above are usually singlesamples and are not associated with any formal samplingplan. Any follow up studies which require testing under theregulations should be done in accordance with the
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requirements of the regulations. Follow up testing is bestdone in conjunction with advice from a Food Examiner18,19
or other appropriately qualified food microbiologist toensure that the most appropriate testing, which mayinclude environmental sampling, is performed.
When using the microbiological criteria within theseguidelines, the food type concerned (including its intrinsicproperties such as pH and water activity, and extrinsicproperties such as temperature, packaging, and gascomposition), the key processing factors, storagetemperature, and shelf-life, should all be considered as well as the sampling framework and selection ofmicrobiological tests.
1.4 Commission Regulation onmicrobiological criteria for foodstuffs European or national regulations are a legal requirementand compliance is mandatory. Microbiological criteria inthe EU have been harmonised in Community legislation bythe European Commission (EC) Regulation onmicrobiological criteria for foodstuffs ([EC] No. 2073/2005[as amended]) which came into force in January 200615,16.This supports the Regulation on the Hygiene of Foodstuffs([EC] No. 852/2004) that also applies from January 20068,and the General Food Law Regulation ([EC] No. 178/2002)that came into force in February 2002, although certainkey provisions applied only from January 200510.In addition, the Regulation laying down specific rules forfood of animal origin ([EC] No. 853/200420) containscriteria for marine biotoxins, for live bivalve molluscs, andraw milk. Interpretative documents relating to theRegulation on microbiological criteria for foodstuffs havebeen produced by the Food Standards Agency (FSA)21 andthe Chilled Food Association (CFA) / British RetailConsortium (BRC)22. A definition of standard terms has alsobeen published by the CFA23. These Regulations apply toall FBOs involved in the production and handling of food.
Two types of microbiological criteria are set out inRegulation (EC) No. 2073/2005 (as amended) and includecriteria for both pathogens and indicator organisms:• Food safety criteria defining the acceptability of a
product or a batch. They are applicable to foodstuffsplaced on the market and throughout the shelf-life ofthe food.
• Process hygiene criteria defining the acceptability of the process. These apply only during the manufacturingprocess.
Failure to meet the criteria alone is not an offence but thespecific corrective action must be carried out to complyfully with the Regulation. Microbiological criteria areintended to assist with validating and verifying HACCP-based food safety management systems.
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Campylobacter, the potentially fatal consequence of thisdisease particularly in the young and the elderly give it ahigh public health significance. It is estimated that VTECinfection is the cause of approximately 70% of the cases ofrenal failure in children35. The consumption of very lownumbers of viable VTEC in food is sufficient to causeinfection36.
Not all cases of VTEC are foodborne (Table 3) and differenttransmission routes can occur within the same outbreak.Most infections in the United Kingdom (UK) are due to asingle serotype of VTEC, i.e. O157, but other serotypeshave been associated with sporadic cases of illness oroutbreaks of foodborne disease. In continental Europe andAustralia, infections from a broader range of VTECserotypes are reported. The other serotypes of VTEC thathave been associated most frequently with disease inhumans include O26, O103, O111 and O14537,38.
2.2.3 Salmonella species Salmonella infection is caused by ingestion of viablebacteria. Infection occurs in all age groups, however hostfactors may increase the susceptibility to infection, forexample treatment to reduce the acidity of the stomach,are more vulnerable to infection. The infectious dose forSalmonella species is usually quite large32. However, datafrom outbreaks has shown that consumption of lownumbers of Salmonella in food together with the mode ofdelivery of the bacterium to the gastrointestinal tract cancause infection and this is particularly evident with high fat/ low water activity foods, such as chocolate, fermentedmeats, cheese and snacks, in which the organism cansurvive for long periods of time39-51. Application of goodhygiene and temperature and time control during food preparation is also important to prevent cross-contamination and multiplication in foods oringredients that are able to support its growth24,52-54.
Around 2,500 serotypes of Salmonella have beendescribed. These serotypes can be further characterisedusing specialist methods to identify strains. TypingSalmonella species in this way is essential for national andinternational surveillance and identification ofoutbreaks24,44-49,55,56. The emergence of new Salmonellastrains or strains that have anti-microbial drug resistancecontributes to the concern regarding imported food. Anti-microbial drug resistant Salmonella infections areassociated with an increased hospitalization rate,morbidity, and mortality57.
2.2.4 Shigella species Shigellosis is caused by ingestion of viable bacteria andmost cases in the UK are due to Shigella sonnei. Infectiondue to other Shigella species including Sh. flexneri, Sh.
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Pathogens
2.1 Introduction Examination for the presence of pathogens in ready-to-eatfood products contributes to food safety24-30. However, thepathogens listed in Tables 1 to 3 are not equally applicableto all food groups. Interpretation of results should also bebased on knowledge of the food product and theproduction process and care must be taken wheninterpreting results obtained in the absence of thisinformation. The significance of the pathogenic micro-organisms in ready-to-eat foods is discussed in thefollowing sections and tables.
2.2 Detection of pathogenic micro-organisms in ready-to-eat food
Detection of the foodborne pathogenic bacteria shown inTable 1 in ready-to-eat food represents an unacceptablerisk to health regardless of the number of bacteria present.The pathogens listed in Table 1 should not be found inready-to-eat food that has been adequately prepared.Table 1 details the likely cause of contamination along withthe suggested actions if the pathogen is detected in ready-to-eat food.
2.2.1 Campylobacter species (thermotolerant)
This is the most common cause of bacterialgastrointestinal infections in the UK. Most cases of diseaseare sporadic and the outbreaks of foodborne infection thatdo occur are difficult to identify. The route of transmissionfor the majority of infections remains unidentified. Theconsumption of low numbers of Campylobacter in food issufficient to cause infection31,32.
Disease is caused by the ingestion of viable thermotolerantCampylobacter species. The most common species ofCampylobacter isolated from cases of foodborne diseaseare C. jejuni and C. coli but illness has also been associatedwith other thermotolerant species. Campylobacter speciesare unable to grow in food, they are killed by heat and areduction in numbers has also been observed followingfreezing of contaminated foodstuffs. Cross contaminationof ready-to-eat foods in the food preparation environmentis an important route of transmission33,34.
2.2.2 Escherichia coli O157 and other verocytotoxin-producing E. coli (VTEC)
The most important Escherichia coli from a food safetyperspective are the verocytotoxin-producing E. coli (VTEC).Despite the relatively low number of cases of VTECinfection compared with that of Salmonella and
SECTION 2
boydii and Sh. dysenteriae also occur. In contrast to themost common foodborne pathogenic agents, shigellosis isexclusively a human disease. The majority of cases in theUK are acquired as a result of person-to-person spread andoccasionally by eating food contaminated by infected foodhandlers, or through the consumption of vegetable or fruitcrops irrigated with untreated water or contaminated byinfected crop workers. Illness can result following theingestion of very low numbers of viable bacteria (as low as10 cells depending on host susceptibility) and it istherefore easily spread from person to person particularlyamongst young children32. Infection can occur in all agesand there is an association between infection and travel toareas where hygiene is poor.
2.2.5 Vibrio choleraeCholera is caused by the ingestion of viable Vibriocholerae. Two serogroups of V. cholerae, O1 and O139have been identified as causing outbreaks. Cholera is anextremely virulent disease that affects both children andadults. It is associated with a rapid onset of severediarrhoea. Case fatality rates of 1-10% have been reportedand this is dependent largely on access to healthcare andtreatment by proper rehydration.
Foodborne transmission occurs through consumption ofcrops cultivated in, or irrigated by, untreated water,through washing or handling foods which receive nofurther processing or by the consumption of raw orundercooked seafood. Foods that are commerciallyimported from countries where V. cholerae is endemichave been, albeit rarely, implicated in outbreaks of choleraand the potential for foodborne transmission fromimported food remains. In the UK, all cases are associatedwith foreign travel particularly to the Indian sub-continent.Food produced under good manufacturing practices poseonly a negligible risk for cholera transmission and thebacterium is killed by adequate cooking.
2.3 Enumeration of pathogenic micro-organisms in ready-to-eat food
Although low numbers of the pathogens listed in Table 2probably represent a low risk, their presence can suggestfault(s) in the production and/or subsequent handlingwhich, if not controlled, could lead to an unacceptableincrease in risk. Contamination by the pathogens listed inTable 2 should always be investigated with an urgency ofresponse which is proportional to the level ofcontamination and type of food as shown in Table 2. In addition, pathogenic bacteria are often unevenlydistributed in foods and the levels of contamination found,and therefore the subsequent interpretation placed onthem, may vary between sub-samples. The detection oflow numbers of these organisms in ready-to-eat foods
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which are thought to be associated with food poisoningoutbreaks or which are consumed by more vulnerablegroups warrants further investigation by the enforcementauthority in consultation with the Food Examiner.Vulnerable people are generally more susceptible to theseinfections and are at greater risk of developing moreserious disease.
2.3.1 Bacillus cereusLarge numbers of Bacillus cereus are needed to causeillness either by releasing toxin into the food prior toconsumption (emetic syndrome) or by producing adifferent toxin or toxins in the gut after eating the food(diarrhoeal syndrome). The emetic syndrome is particularlyassociated with farinaceous products such as rice andpasta dishes. A wider range of foods have been implicatedwith the diarrhoeal syndrome including meat products,soups, vegetables, puddings and sauces.
Bacillus cereus is a diverse group of bacteria which arewidespread in the environment, therefore all foods andfood ingredients are likely to be contaminated by thespores of this bacterium. The spores may survive thecooking process, hence people are frequently exposed tolow numbers of B. cereus through food without becomingill. Minimum growth temperatures for B. cereus varybetween 4°C and 12°C with an upper limit of around50°C although some psychrotrophic strains occur. Not allstrains produce toxins that cause either the emetic ordiarrhoeal disease. The emetic and diarrhoeal toxins aredistinct; the emetic toxin is pre-formed in food and is bothacid and heat stable. Hence foods can be toxic in theabsence of viable B. cereus.
2.3.2 Bacillus species (other pathogenic Bacillus)
Illness is caused by the Bacillus subtilis group (including B.subtilis, B. licheniformis, B. pumilis and B. amyloliquifaciens)and occurs less frequently than B. cereus gastroenteritis.Symptoms are similar to those from B. cereus and includeacute-onset vomiting often followed by diarrhoea, as well asdiarrhoea accompanied infrequently by vomiting. Illness isstrain and possibly species dependent. Illness follows theconsumption of a wide variety of poorly stored cookedfoods containing large numbers of Bacillus (105 to 109 cfu/gor more) and includes food prepared from poultry, meat,vegetables, and farinaceous products such as rice andbread. The temperature range for growth is similar to B.cereus (see section 2.3.1). The exact mechanisms andtoxins produced by this group are less well understood thanfor B. cereus but some may be associated with preformedtoxin, and some with viable organisms. Not all of the B.subtilis group have the potential to cause disease, indeedsome natural fermentations which rely on production ofvery high levels of these bacteria result in safe products.
Spices and spice products such as pepper and curry pasteoften carry a significantly high load of Bacillus species,usually in the spore form. Although these are not normallyregarded as ready-to-eat foods they may be added to aready-to-eat food as a garnish or seasoning, albeit as a verysmall proportion of the finished product. However,depending on the nature of the food to which they areadded, outgrowth is possible and may then pose a healthrisk. Levels in spices exceeding 106 cfu/g are thereforeregarded as unsatisfactory. If high levels of Bacillus spp. arefound in ready-to-eat foods, the possibility that spices suchas pepper have been added after the main cookingprocess, for example to the egg mayonnaise or mashedpotato topping, should be investigated.
2.3.3 Clostridium perfringensClostridium perfringens is found in the gut and thusindicates faecal contamination although spores commonlyoccur in the environment. It is uncommon to detect thisorganism in properly handled ready-to-eat foods. Illness iscaused by the ingestion of large numbers of viablevegetative bacteria, which sporulate in the lower smallintestine and produces enterotoxin which causesdiarrhoea. This enterotoxin is not produced in foods.Spores are common in the environment and may survivethe cooking process such that low level contamination ofthe final product may occasionally occur. Control isachieved by preventing spore germination and growth infood and rapid cooling, adequate cold storage andadequate reheating of food are of paramount importance.C. perfringens will grow between 15°C and 52°C withvirtually no growth below 12°C. Not all C. perfringensproduce enterotoxin and these non-toxigenic isolates(irrespective of the numbers of bacteria present) will notproduce foodborne disease. However the presence ofhigh numbers of non-toxigenic C. perfringens in aready-to-food is unsatisfactory and indicates poorprocessing, particularly during cooling.
2.3.4 Listeria monocytogenesIllness is caused by the ingestion of live bacteria. Listeriamonocytogenes occurs commonly in the environment andin raw foods, and consequently will occur in some foodproduction environments. Growth of this bacteriumfollowing both post-process contamination of cooked orprocessed foods or in raw foods probably represents thegreatest risk for disease transmission. L. monocytogenescan grow between <0°C to 45°C, albeit slowly atrefrigeration temperatures. The bacterium is killed byadequate cooking. Unrefrigerated foods and those chilledfor extended periods are at increased risk of allowingsignificant growth, particularly if chilled temperatures aresuboptimal. Vulnerable groups (pregnant women, theimmunosuppressed, the elderly, and many patients in
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hospitals) are at particular risk of infection, henceconsumption of low levels of L. monocytogenes may be ofgreater risk when eaten by these groups.
In refrigerated high risk foods such as soft ripened cheese,pâté, smoked fish, and cooked sliced meat, where there isa potential for growth during storage, and in foods likely tobe served to vulnerable groups (such as those served inhospital), the presence of L. monocytogenes at any levelmay be of public health significance and should beinvestigated. For these high risk food products and toassess the public health significance it is thereforerecommended that an enrichment method be used, inaddition to enumeration, to ensure that there is anabsence of the bacterium in 25g portions of these foods (Table 2).
Food safety criteria for L. monocytogenes in Regulation(EC) No. 2073/2005 (as amended)16 are applicable tothree categories of ready-to-eat foods: absence of L. monocytogenes in 25g is required in some foods, e.g.ready-to-eat foods intended for infants and those forspecial medical purposes; while for other ready-to-eatfoods (including those able to support growth or not of L. monocytogenes) L. monocytogenes should not exceed102 cfu/g within the shelf-life. However investigation onpublic health grounds may be justified in products withlevels of less than 102 cfu/g, especially in high risk foods,those likely to be consumed by vulnerable groups andthose which are defined in Regulation (EC) No. 2073/2005that do not support the growth (based on a shelf life ofless than 5 days) but where growth may occur under poortemperature and time control.
2.3.5 Staphylococcus aureus and other coagulase-positive staphylococci
Illness due to Staphylococcus aureus is caused byenterotoxins which are preformed in food. Only some S.aureus contain enterotoxin genes and therefore have thepotential to cause food poisoning. Although most cases ofinfection are due to S. aureus, other coagulase-positiveStaphylococcus species (e.g. S. intermedius) can alsoproduce enterotoxins and cause foodborne disease.
Adequate cooking will kill the bacterium, however someprotection is afforded in dry, high-fat and high-salt foods.Staphylococcal enterotoxins are heat-stable and can survivesome normal cooking processes including boiling, henceactive toxin can be present in the absence of viableorganisms. Most coagulase-positive staphylococci growbetween 7°C and 48°C with no growth at refrigerationtemperatures. Many people carry S. aureus andcontamination of foods after processing by food handlerscan occur. Toxin production starts at 10°C and storage offoods below this should prevent its development.
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In foods such as ripened cheeses and fermented meatproducts, S. aureus levels are highest 2–3 days after initialproduction and may reduce significantly during storage. If levels exceed 105 cfu/g at any time during the life of afood, there is a risk of sufficient enterotoxin to cause illnessthat will remain in the food product regardless ofsubsequent recoverable levels of this organism. Howevercheese products sampled at retail with coagulase-positivestaphylococci levels in excess of 103 cfu/g should beregarded with suspicion and further investigation iswarranted, for example by arranging for checks of theproducer’s test records. If levels exceed 104 cfu/g, isolatesshould be sent to the Reference Laboratory for enterotoxingene testing. If levels exceed 105 cfu/g in any product or ifthe food is associated with possible staphylococcal foodpoisoning, the food (if available) should be tested forenterotoxin and the strain for enterotoxin gene detection.
The only food safety criterion for staphylococci inRegulation (EC) No. 2073/2005 (as amended) is for anabsence of staphylococcal enterotoxins in cheese, milkpowder and whey powder in product placed on themarket during their shelf life16. This Regulation has processhygiene criteria with limits of between 10 and 105
coagulase positive staphylococci/g in cheese, milk andwhey powder during manufacture, and if values of >105
cfu/g are detected, the batch should be tested forstaphylococcal enterotoxins. However, since assays forenterotoxin detection are not rapid, can be insensitive forsome food matrices and do not detect all types ofstaphylococcal enterotoxins, public health actions shouldnot be delayed pending results.
2.3.6 Vibrio parahaemolyticus Vibrio parahaemolyticus is a marine bacterium found incoastal and estuarine waters. It is a rare cause of illness in the UK and is most frequently associated with the ingestion of live Vibrio parahaemolyticus in uncooked imported seafood or ingestion of foods cross-contaminated with seafood. Growth has beenreported between 14°C and 40°C and therefore does not occur in seafood stored at proper refrigerationtemperatures; however freezing does not destroy theorganism but it is killed by most heat treatments. Many isolates appear unable to produce the toxinresponsible for causing the disease.
2.4 Foodborne pathogens and risk of diseaseFurther details on some of these pathogens including themost common foods associated with them and thesettings or locations most frequently associated withoutbreaks of disease are provided in Table 3. This tablealso identifies the most common routes of transmission,known host risk factors for more severe infection, the
symptoms and possible consequences of infection, andtheir frequency as a cause of human illness in the UK.
Foodborne diseases of microbiological origin can becaused by a variety of agents, which gain entry by thegastrointestinal tract. Symptoms of foodborne disease,which are not necessarily confined to diarrhoea andvomiting, are caused by viable organisms and/or by thetoxins that they produce. The risk of disease from theseagents varies depending on the pathogen, the dose, thehost and the properties of the food matrix. Host riskfactors include age, immune status, underlying debilitatingdisease or stress factors, and the physiological state of thestomach and upper small intestine at the time of exposureto the agent. For these reasons a minimum infectious dosecannot be defined, although the risk of disease at lowexposure for some agents is small.
The presence of foodborne agents that may cause illnessin ready-to-eat foods is a significant risk to consumerhealth and their absence is of paramount importance.With the exception of the aerobic and anaerobic bacterialspores, detection of foodborne pathogenic agents at anylevel is of concern and should be investigated with anurgency of response proportionate to the level ofcontamination and risk to consumers. Although lownumbers of pathogens, such as coagulase-positivestaphylococci, C. perfringens, B. cereus, and L. monocytogenes, in ready-to-eat products probablyrepresent a very low risk to immunocompetent people,they are more significant for the immunocompromisedand vulnerable groups. Low levels may be due to naturalcontamination of raw materials used in those foods, butusually their presence suggests faults in the production orsubsequent handling of food which could lead to anunacceptable increase in risk. There may also be a need foraction when detecting low numbers of these organisms inready-to-eat foods because there is variation in hostsusceptibility and interstrain differences in thepathogenicity of these bacteria.
2.5 Specialist and reference testsSpecialist and reference tests are available for manyfoodborne pathogens and their toxins, the results of whichwill provide considerable added value to those from initialtests and to epidemiological investigations. Specialist orreference tests are performed for:• Verification of the microbiological results from the
primary laboratory;• Identification of rare or unusual pathogens; • Comparative (fingerprinting or typing) analyses for strain
characterisation to establish likely relationships betweencultures from samples collected during outbreaks and at different times or from different places in the food chain;
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• Detection of toxins, and/or the potential to produce a toxin;
• Distinction, where possible, between non-pathogenic and pathogenic variants of the same species;
• Assessment of the likely disease severity;• Detection of additional bacterial pathogens as well as
viruses (e.g. norovirus) and parasites.
Tests for Cronobacter (Enterobacter) sakazakii, Clostridiumbotulinum neurotoxin, staphylococcal enterotoxins, Bacillustoxins, histamine and shellfish toxins, norovirus andparasites are usually only available at national orinternational reference laboratories. Given the specialistand complex nature of some of these tests, results maynot be available as quickly as primary tests. Hence publichealth actions and interventions should not be delayedpending the results of specialist and reference tests.
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(depending on the type of product) are set by Regulation(EC) No. 2073/2005 (as amended)16.
3.3 Escherichia coli Escherichia coli belongs to the Enterobacteriaceae familyand is used as a faecal indicator to assess the hygienestatus of a food product. Escherichia coli are killed by theheat processes used in food production and should bereadily removed from the factory, equipment and surfacesby appropriate cleaning procedures. Occasional strains arepathogenic; these are rarely found in ready-to-eat foodsalthough not all can be recovered by currently availabledetection laboratory methods. Specialist methods todetect pathogenic strains are required when illness is suspected.
Escherichia coli may sometimes be found in soft, mould-ripened or washed-rind cheese made from raw milk.Although Regulation (EC) No. 2073/2005 (as amended)has no criteria for E. coli in cheese made from raw milk16 itis recommended that these cheese types be routinelytested for E. coli and investigation undertaken if a changein trend is detected. It is also recommended that a riskassessment is performed to assess the need for periodicmonitoring for VTEC O157. Tests should be urgentlyapplied where there is epidemiological evidence linkingVTEC infection with specific foods (please refer to Table 1and section 2.2.2 for information on VTEC O157).
3.4 Listeria species Listeria spp. are able to grow at normal refrigerationtemperatures but are killed by temperature regimes suchas 70°C for two minutes. These organisms show a greaterresistance to heat than the Enterobacteriaceae. In foodsthat have undergone such a heat treatment the presenceof Listeria spp. indicates undercooking or post processcontamination. Their presence can be used as an indicatorto assess the hygienic status of a food product. Listeriaspp. are also environmental contaminants that can survivein both food processing premises and on equipment ifinappropriate hygiene measures are used. These organismsare less sensitive to the cleaning procedures used in foodprocessing environments than many other bacteria.
The term Listeria spp. is fully inclusive of all Listeria spp.,including L. monocytogenes. The occurrence of thesebacteria at any level may therefore be of significance incertain refrigerated high risk foods (e.g. soft ripenedcheese, pâté, smoked fish, cooked sliced meats) due to thepotential for growth during storage in some of theseproducts. For these products it is therefore recommendedthat an enrichment method be used, in addition toenumeration, to check that there is an absence of Listeriaspp. in 25g of food (Table 4).
/ / 12
Hygiene IndicatorOrganisms
3.1 Introduction The presence of indicator bacteria in ready-to-eat food,although not inherently a hazard, can be indicative of poorpractice that may be one or more of the following: • poor quality of raw materials or food components;• undercooking;• cross-contamination;• poor cleaning; • poor temperature and time control.
Indicator bacteria may be associated with an increasedlikelihood of the presence of pathogens58. Indicatororganisms are useful in the assessment of food productsafety because they tend to be present in higher numbersthan most pathogens and are relatively quick and easy to identify.
There are a number of recommended actions listed inTable 4 that could be taken in response to anunsatisfactory result for indicator bacteria. Several foodsfrom the same premises with borderline levels of indicatorsshould prompt further investigation. It is recommendedthat any proposed actions should be discussed with a Food Examiner.
3.2 Enterobacteriaceae The Enterobacteriaceae family is a group of bacteria that isused to assess the general hygiene status of a foodproduct. This group includes species that originate fromthe intestinal tract of animals and humans, as well asplants and the environment. All Enterobacteriaceae arekilled by the heat processes used in food production andshould be readily removed from the factory, equipmentand surfaces by appropriate cleaning procedures. Theirpresence in heat treated foods therefore signifiesinadequate cooking or post-processing contamination.High levels of these bacteria are expected in some foodcommodities such as salad vegetables. The use ofsanitising rinses may reduce but not entirely remove these organisms.
Some Enterobacteriaceae can contribute to the formationof histamine (scombrotoxin) in foods such as scombroidfish (e.g. mackerel and tuna) and occasionally somecheeses if these are not processed properly and/or storedat an adequate refrigeration temperature. Ingestion of fishwith high histamine levels is toxic, and maximumpermissible levels of <200 or <400 mg/kg of histamine
SECTION 3
G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 13
spoilage organisms such as psychrotrophic pseudomonads;a lower refrigeration temperature will reduce the rate ofgrowth further and help to extend shelf-life. As theduration of storage increases the aerobic colony count alsoincreases; this will also occur if refrigeration temperaturesare poorly controlled or if the food is frequently taken inand out of refrigeration.
An ACC of less than 106 cfu/g is usually associated with amixed flora. Above this level there is usually a predominantorganism, and the acceptability and organoleptic quality ofthe food will depend on which type of organismpredominates. In meat products for example the florafrequently consists almost entirely of lactic acid bacteria(mainly lactobacilli and streptococci), which can grow wellat refrigeration temperatures. Spoilage will eventuallyoccur at a level of around 109 cfu/g due to the productionof lactic acid. If the predominant organism or group oforganisms consists of Gram-negative bacteria, spoilage islikely to be noticeable at 107 – 108 cfu/g; pseudomonadstend to produce taints, discolouration, and slime whilstother Gram-negative bacteria frequently produce slime.Yeasts may cause spoilage at slightly lower levels (106 –107 cfu/g) due to acid and gas production. If high levels ofBacillus spp. are found this may be due to the addition ofpepper or other spices after any heat treatment;investigations of the full preparation process is needed. If ACCs are high it is therefore important to identify thepredominant organism type in order to fully interpret thesignificance of the level. Tests by the laboratory forcatalase and oxidase production and a Gram stain areusually sufficient to achieve the differentiation needed tointerpret results.
For raw, ready-to-eat food commodities such as saladvegetables, ACCs are likely to be much higher, between106 and 108 cfu/g. This will tend to limit their shelf-life asspoilage may occur relatively rapidly and will usually bevisible. This also applies to products such as rice or pastasalads containing raw vegetables. If products are dried(e.g. herbs), the ACC per gram appears to increase due tothe volume of water being removed. Raw meat and fish,eaten untreated or cold smoked, will also have ACCs ofaround 106 – 107 cfu/g, whereas marinated products arelikely to have lower counts due to the acidity of themarinade unless they have been spoiled. Some foodcommodities such as fermented meats, fish, vegetablesand most types of cheese are produced by adding startercultures of bacteria; the predominant organisms aretherefore the starter bacteria and other bacteria are usuallypresent only in low numbers due to the acidity producedduring the fermentation.
/ / 14
Aerobic ColonyCounts
4.1 Introduction The Aerobic Colony Count (ACC), also known as the TotalViable Count or Standard Plate Count, is an indicator ofquality, not safety, and cannot directly contribute towardsa safety assessment of ready-to-eat food.
4.2 ACC levels in various ready-to-eat foodsACCs can be used as part of a general quality assessmentincluding that of extended shelf-life foods; as such it canbe used as part of a programme of shelf-life testing carriedout by the food producer: • If an ACC is above the expected level, a determination of
the constituent organisms and their level is needed before any follow-up investigation is instigated;
• High counts may suggest quality issues and possible poor temperature control and these should be investigated.
Immediate action in response to high ACCs is not usuallywarranted except for shelf-stable canned or bottled foodproducts immediately after opening (Category 1, Table 5).The level will depend initially on the type and duration ofprocessing that the food has received during production(see Table 5). Thereafter the level will depend on the wayit is handled and stored. For example, immediately after apasteurisation heat process, products will normally have anACC of below 104 cfu/g, whilst a more rigorous heatprocess such as grilling, roasting or baking will result incounts below 103 cfu/g. For canned products that aremicrobiologically stable at ambient temperature, viablemicro-organisms are usually absent but occasionallythermotolerant spores may survive, depending on theseverity of the heat process. Products that have received adrying process will be stable whilst remaining dry, but maycontain relatively high numbers of bacteria that canmultiply following rehydration.
Microbes are inevitably introduced during slicing,packaging, portioning and other manipulations but thisshould be minimised by good hygiene, both of personneland of equipment. The type of packaging may theninfluence the rate of microbial growth, for examplevacuum packaging will retard the growth of obligateaerobic organisms due to the exclusion of oxygen. Thetemperature of refrigeration for non-ambient stableproducts also influences the microbial growth rate; storagebelow 8°C will prevent growth of most foodbornepathogens (with the notable exceptions of Listeriamonocytogenes and Yersinia enterocolitica) but not of
SECTION 4
type of packaging, and the culturability of injuredorganisms will also contribute further to the variation ofreproducibility between microbiological results. Resultsshould therefore be interpreted in context taking suchfactors into consideration. Criteria for other agentsincluding viruses and enteric parasites are currentlyexcluded; however as European Standard methods (EN)become available these may be included in the future.
5.2 Environmental samplesThese guidelines do not include microbiological criteria forand interpretation of microbiological results fromenvironmental samples. Sampling the food environmentwill be the subject of additional HPA guidance. However,taking appropriate and targeted environmental samples isrecommended in these guidelines for unsatisfactory resultson ready-to-eat foods and should also be considered forborderline values. Testing the food environment makes apositive and additional contribution to food safety.
As a guide environmental sampling is useful in thefollowing situations: • In an outbreak/incident investigation, environmental
samples should be taken as soon as possible as part of the primary sampling exercise. Detection of pathogensin environmental samples is important because it may provide the only evidence to link a particular premise toan outbreak of infection;
• For hygiene indicators during an investigation into poormicrobiological results or during an inspection of apremises especially where there are concerns about thepotential for cross contamination;
• As part of the follow-up to assess the effectiveness of deep cleaning of premises which have been shown to be contaminated with pathogens.
G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 15
SECTION 5
This diversity of food products and the productionmethods used means that a good understanding of theproduct type is needed in order to fully interpret the ACC.Guidance is given in Table 5 but careful considerationshould be given to the type of food being tested andwhether it is truly ready-to-eat or an ingredient thatrequires a further heating process before consumption.The stage of shelf-life should also be considered; ifsampled at the point of production ACCs are likely tocategorise foods as “satisfactory”, whereas if sampled atthe end of shelf-life an ACC can normally be expected toapproach the upper “borderline” limit. If used correctlyACCs can provide useful information about the generalquality and remaining shelf-life of the food in question, andthus highlight potential problems of storage and handlingsince production; however they are not deemed a priorityin a risk based analysis.
SupplementaryAdvice on Use of the Guidelines
5.1 Microbiological methodology Laboratory methods that allow rapid and accuratedetection, identification and quantification ofmicrobiological hazards enhance the ability to monitor and investigate contamination throughout the food chain.Methods are defined for Official Control sampling15,16,20,59.However for public health investigations and for reasons ofincreased speed or sensitivity, different methods (as well assample sizes) may be utilised as long as they have beenvalidated according to internationally acceptable protocolsand their use authorised by the Competent Authority.
The interpretation of laboratory results in foodmicrobiology is often the most difficult and complexaspect of the examination process. Users of theseguidelines should be aware that the precision andreproducibility of many microbiological tests depends onmany factors, some of which are outside the control of thelaboratory. Sampling itself is the greatest contributoryfactor to the variability of a result for a particular sample asmicro-organisms are not usually homogenously distributedin a contaminated foodstuff. The sample matrix itself, the
/ / 16
Tables
SECTION 6
G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 17
Haz
ard
Cam
pyl
ob
acte
rsp
p.
(th
erm
oto
lera
nt)
Esch
eric
hia
coli
O15
7(a
nd
oth
erve
rocy
toto
xin
-p
rod
uci
ng
E.co
li(V
TEC
))
Salm
on
ella
spp
.
Shig
ella
spp
.
Vib
rio
cho
lera
e(O
1an
dO
139)
Resu
lt/2
5g
a
Det
ecte
d
Not
dete
cted
Det
ecte
d
Not
dete
cted
Det
ecte
d
Not
dete
cted
Det
ecte
d
Not
dete
cted
Det
ecte
d
Not
dete
cted
Mic
rob
iolo
gic
alR
isk
Cat
ego
ry
Hig
h
Low
Hig
h
Low
Hig
h
Low
Hig
h
Low
Hig
h
Low
Inte
rpre
tati
on
UN
SATI
SFA
CTO
RY:
Pote
nti
ally
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rio
us
toh
ealt
han
d/
or
un
fit
for
hu
man
con
sum
pti
on
b
SATI
SFAC
TORY
UN
SATI
SFA
CTO
RY:
Pote
nti
ally
inju
rio
us
toh
ealt
han
d/
or
un
fit
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hu
man
con
sum
pti
on
b
SATI
SFAC
TORY
UN
SATI
SFA
CTO
RY:
Pote
nti
ally
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rio
us
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han
d/
or
un
fit
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man
con
sum
pti
on
b
SATI
SFAC
TORY
UN
SATI
SFA
CTO
RY:
Pote
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ally
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rio
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han
d/
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un
fit
for
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man
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sum
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on
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SATI
SFAC
TORY
UN
SATI
SFA
CTO
RY:
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TORY
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onta
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ated
irrig
atio
nw
ater
Sug
ges
ted
Act
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s(N
ot
excl
usi
ve)
NB:
Perf
orm
risk
asse
ssm
ent
befo
rean
yfu
rthe
rac
tion
Imm
edia
tein
vest
igat
ion
of:t
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odor
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proc
ess
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take
inve
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ativ
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N/A
Imm
edia
tein
vest
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of:t
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odor
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edia
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,pro
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vest
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ofhy
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Imm
edia
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igat
ion
of:t
hefo
odor
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,pro
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and
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ion
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form
atio
nin
clu
din
gla
bo
rato
rysp
ecia
list
and
refe
ren
cete
stsc
Actio
nssh
ould
not
bede
laye
dpe
ndin
gre
sults
ofsp
ecia
list
test
s.
Con
firm
atio
nof
iden
tity,
mol
ecul
arty
ping
.
Con
firm
atio
nof
iden
tity
sero
typi
ng,
phag
ety
ping
vero
cyto
toxi
nty
ping
,m
olec
ular
typi
ng.
Con
firm
atio
nof
iden
tity,
sero
typi
ng,p
hage
typi
ng,
anti-
mic
robi
alre
sist
ance
patt
erns
,m
olec
ular
typi
ng.R
egul
atio
n(E
C)
No.
2073
/200
5(a
sam
ende
d)co
ntai
nsm
icro
biol
ogic
alcr
iteria
for
som
esp
ecifi
cfo
od/
Salm
onel
laco
mbi
natio
nsan
dth
ere
quire
men
tsto
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ied
with
byFB
Os.
Con
firm
atio
nof
iden
tity,
sero
typi
ng,m
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ular
typi
ng.
Con
firm
atio
nof
iden
tity,
sero
typi
ng,
mol
ecul
arty
ping
.
Tab
le1.
Gui
danc
eon
the
inte
rpre
tatio
nof
resu
ltsfo
rde
tect
ion
ofba
cter
ialp
atho
gens
(the
haza
rd)
inre
ady-
to-e
atfo
ods
plac
edon
the
mar
ket.
a,It
isco
mm
onpr
actic
efo
r25
gof
food
tobe
test
edw
ithth
eas
sum
ptio
nth
atab
senc
ein
25g
isSA
TISF
ACTO
RY.T
estin
gof
mor
eor
less
food
may
how
ever
bein
dica
ted
durin
gou
tbre
akin
vest
igat
ions
orw
hen
sam
plin
gis
base
don
Regu
latio
n(E
C)
No.
2073
/200
5(a
sam
ende
d).S
ome
read
y-to
-eat
food
sar
eta
ken
asO
ffic
ialC
ontr
olsa
mpl
es,p
leas
ere
fer
toth
efo
odsa
fety
orpr
oces
shy
gien
ecr
iteria
inRe
gula
tion
(EC
)N
o.20
73/2
005
(as
amen
ded)
for
mic
robi
olog
ical
crite
riaan
dsa
mpl
ing
plan
s.b,
Regu
latio
n(E
C)
No.
178/
2002
,Art
icle
14Fo
odsa
fety
requ
irem
ents
.c,
All
isol
ates
shou
ldbe
sent
toth
ere
fere
nce
labo
rato
ryfo
rco
nfirm
atio
nex
cept
for
Cam
pylo
bact
ersp
p.w
here
only
thos
eas
soci
ated
with
outb
reak
inve
stig
atio
nssh
ould
bere
ferr
ed.
/ / 18
Haz
ard
Bac
illu
sce
reu
s
Oth
erp
ath
og
enic
Bac
illu
ssp
p.
(B.s
ub
tilis
gro
up
)
Resu
lt(c
fu/g
)a
>105
103
-≤1
05
<103
>105
103
-≤1
05
<103
Mic
rob
iolo
gic
alR
isk
Cat
ego
ry
Hig
h
Mod
erat
e
Low
Hig
h
Mod
erat
e
Low
Inte
rpre
tati
on
UN
SATI
SFA
CTO
RY:
Pote
nti
ally
inju
rio
us
toh
ealt
han
d/
or
un
fit
for
hu
man
con
sum
pti
on
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BORD
ERLI
NE
SATI
SFAC
TORY
UN
SATI
SFA
CTO
RY:
Pote
nti
ally
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rio
us
toh
ealt
han
d/
or
un
fit
for
hu
man
con
sum
pti
on
b
BORD
ERLI
NE
SATI
SFAC
TORY
Like
lyC
ause
Stro
ngev
iden
cefo
rpo
orpr
oces
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ality
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ls,
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orte
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ntro
l
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iden
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oces
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rqu
ality
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mat
eria
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orte
mpe
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l
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orte
mpe
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ntro
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lyev
iden
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ality
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rpo
orte
mpe
ratu
reco
ntro
l
Sug
ges
ted
Act
ion
s(N
ot
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usi
ve)
NB:
Perf
orm
risk
asse
ssm
ent
befo
rean
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rthe
rac
tion
Imm
edia
tely
revi
ewte
mpe
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ular
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est
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eof
cook
edfo
ods.
Take
inve
stig
ativ
esa
mpl
esof
food
,raw
food
com
pone
nts
and
the
food
prep
arat
ion
envi
ronm
ent.
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will
incr
ease
prop
ortio
nalt
oth
ele
vels
dete
cted
.Foo
dm
ayno
tbe
com
eha
zard
ous
prov
ided
appr
opria
tele
vels
ofco
ntro
lare
appl
ied.
Revi
ewte
mpe
ratu
rean
dtim
eco
ntro
lspa
rtic
ular
lyfo
rco
oked
food
s.C
onsi
der
taki
ngin
vest
igat
ive
sam
ples
offo
od,r
awfo
odco
mpo
nent
san
dth
efo
odpr
epar
atio
nen
viro
nmen
t.
N/A
Imm
edia
tely
revi
ewte
mpe
ratu
rean
dtim
eco
ntro
lspa
rtic
ular
lyfo
rth
est
orag
eof
cook
edfo
ods.
Take
inve
stig
ativ
esa
mpl
esof
food
,raw
food
com
pone
nts
and
the
food
prep
arat
ion
envi
ronm
ent.
Risk
will
incr
ease
prop
ortio
nalt
oth
ele
vels
dete
cted
.Foo
dm
ayno
tbe
com
eha
zard
ous
prov
ided
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ntro
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ied.
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ewte
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rean
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ntro
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rtic
ular
lyof
cook
ing
food
s.C
onsi
der
taki
ngin
vest
igat
ive
sam
ples
offo
od,r
awfo
odco
mpo
nent
san
dth
efo
odpr
epar
atio
nen
viro
nmen
t.
N/A
Ad
dit
ion
alin
form
atio
nin
clu
din
gla
bo
rato
rysp
ecia
list
and
refe
ren
cete
stsc
Actio
nssh
ould
not
bede
laye
dpe
ndin
gre
sults
ofsp
ecia
list
test
s.
Not
alls
trai
nspr
oduc
eto
xins
and
are
able
topr
oduc
ega
stro
inte
stin
aldi
seas
e,C
onfir
mat
ion
ofid
entit
y,m
olec
ular
typi
ng
Repo
rted
aspr
esum
ptiv
eB.
cere
usun
less
asso
ciat
edw
ithan
outb
reak
inve
stig
atio
nw
hen
conf
irmat
ion
and
typi
ngar
epe
rfor
med
Repo
rted
,if
pres
ent,
aspr
esum
ptiv
eB.
cere
us
Not
alls
trai
nspr
oduc
ega
stro
inte
stin
aldi
seas
e.C
onfir
mat
ion
ofid
entit
y,m
olec
ular
typi
ng
Hig
hle
vels
occu
rin
spec
ific
ferm
ente
dpr
oduc
tsan
ddo
not
repr
esen
ta
publ
iche
alth
risk
Repo
rted
aspr
esum
ptiv
eBa
cillu
ssp
p.un
less
asso
ciat
edw
ithan
outb
reak
inve
stig
atio
nw
hen
conf
irmat
ion
and
typi
ngar
epe
rfor
med
Repo
rted
,if
pres
ent,
aspr
esum
ptiv
eBa
cillu
ssp
p.
Tab
le2
.Gui
danc
eon
the
inte
rpre
tatio
nof
resu
ltsfo
ren
umer
atio
nof
bact
eria
lpat
hoge
ns(t
heha
zard
)in
read
y-to
-eat
food
spl
aced
onth
em
arke
t
G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 19
Clo
stri
diu
mp
erfr
ing
ens
List
eria
mo
no
cyto
gen
es
>104
10-
≤104
<10
>102
10-
≤102
c
<10d
Hig
h
Mod
erat
e
Low
Hig
h
Mod
erat
e
Low
UN
SATI
SFA
CTO
RY:
Pote
nti
ally
inju
rio
us
toh
ealt
han
d/
or
un
fit
for
hu
man
con
sum
pti
on
b
BORD
ERLI
NE
SATI
SFAC
TORY
UN
SATI
SFA
CTO
RY:
Pote
nti
ally
inju
rio
us
toh
ealt
han
d/
or
un
fit
for
hu
man
con
sum
pti
on
b
BORD
ERLI
NE
SATI
SFAC
TORY
Stro
ngev
iden
cefo
rpo
orpr
oces
sing
,pa
rtic
ular
lydu
ring
cool
ing
perio
daf
ter
cook
ing,
the
use
ofle
ftov
erfo
od,o
rfr
omst
ocks
and
grav
ies
Like
lyev
iden
cefo
rpo
orpr
oces
sing
part
icul
arly
cool
ing
Stro
ngev
iden
cefo
rpo
orpr
oces
sing
,en
viro
nmen
talo
rcr
oss-
cont
amin
atio
ndu
ring
prod
uctio
nor
atpo
int
ofsa
le,p
oor
tem
pera
ture
cont
rolo
rin
appr
opria
tele
ngth
ofsh
elf-
life
Like
lyev
iden
cefo
rpo
orpr
oces
sing
and/
orpo
orqu
ality
raw
mat
eria
ls
Imm
edia
tely
revi
ewte
mpe
ratu
rean
dtim
eco
ntro
ls.T
ake
inve
stig
ativ
esa
mpl
esof
food
and
the
food
prep
arat
ion
envi
ronm
ent.
Risk
will
incr
ease
prop
ortio
nalt
oth
ele
vels
dete
cted
and
the
likel
ihoo
dof
subs
eque
ntgr
owth
inth
eab
senc
eof
appr
opria
tele
vels
ofco
ntro
l.Re
view
tem
pera
ture
and
time
cont
rols
part
icul
arly
cool
ing
and
stor
age
prac
tices
inpl
ace
topr
even
tgr
owth
.Con
side
rta
king
inve
stig
ativ
esa
mpl
esof
food
and
the
food
prep
arat
ion
envi
ronm
ent.
N/A
Imm
edia
tein
vest
igat
ion
of:t
hefo
odor
igin
,pro
duct
ion
proc
ess
and
envi
ronm
ent.
Take
inve
stig
ativ
esa
mpl
esof
food
and
envi
ronm
enta
lmon
itorin
g.
Risk
will
incr
ease
prop
ortio
nalt
oth
ele
vels
dete
cted
and
the
likel
ihoo
dof
subs
eque
ntgr
owth
unde
rno
rmal
stor
age
cond
ition
s.Re
view
qual
ityof
raw
mat
eria
ls,f
ood
prep
arat
ion
envi
ronm
ent
(incl
udin
gcl
eani
ng),
cook
ing,
tem
pera
ture
and
shel
flif
eco
ntro
ls.
Con
side
rta
king
inve
stig
ativ
esa
mpl
esof
food
and
envi
ronm
enta
lmon
itorin
g.In
refr
iger
ated
high
risk
food
sw
here
ther
eis
apo
tent
ialf
orgr
owth
durin
gst
orag
e,an
din
food
slik
ely
tobe
serv
edto
vuln
erab
legr
oups
(suc
has
that
serv
edin
hosp
ital)
the
pres
ence
ofL.
mon
ocyt
ogen
esat
any
leve
lmay
beof
sign
ifica
nce
and
shou
ldbe
inve
stig
ated
.
N/A
Con
firm
atio
nof
iden
tity,
typi
ng,
path
ogen
icity
(tox
inge
nede
tect
ion)
Refe
ris
olat
esas
soci
ated
with
anou
tbre
akin
vest
igat
ion
Refe
ris
olat
esfo
rco
nfirm
atio
nof
iden
tity,
sero
typi
ng,
mol
ecul
arty
ping
.
Con
side
rre
ferr
alof
isol
ates
,pa
rtic
ular
lyw
here
asso
ciat
edw
ithpe
rsis
tent
cont
amin
atio
nor
aspa
rtof
outb
reak
inve
stig
atio
ns.
For
food
sin
high
risk
cate
gorie
sc,
refe
ris
olat
esfo
rre
fere
nce
test
ing.
Regu
latio
n(E
C)
No.
2073
/200
5(a
sam
ende
d)co
ntai
nsm
icro
biol
ogic
alcr
iteria
for
som
esp
ecifi
cfo
od/
L.m
onoc
ytog
enes
com
bina
tions
and
the
requ
irem
ents
tobe
com
plie
dw
ithby
FBO
s.
/ / 2 0
Stap
hyl
oco
ccu
sau
reu
san
do
ther
coag
ula
se-p
osi
tive
stap
hyl
oco
cci
Vib
rio
par
ahae
mo
lyti
cus
>104
20-
≤10
4
<20
>103
20-
≤10
3
<20
Hig
h
Mod
erat
e
Low
Hig
h
Mod
erat
e
Low
UN
SATI
SFA
CTO
RY:
Pote
nti
ally
inju
rio
us
toh
ealt
han
d/
or
un
fit
for
hu
man
con
sum
pti
on
b
BORD
ERLI
NE
SATI
SFAC
TORY
UN
SATI
SFA
CTO
RY:
Pote
nti
ally
inju
rio
us
toh
ealt
han
d/
or
un
fit
for
hu
man
con
sum
pti
on
b
BORD
ERLI
NE
SATI
SFAC
TORY
Stro
ngev
iden
cefo
rpo
orha
ndlin
gan
dte
mpe
ratu
reco
ntro
l.
Like
lyev
iden
cefo
rpo
orha
ndlin
g,pr
oces
san
dte
mpe
ratu
reco
ntro
l.
Stro
ngev
iden
cefo
rpo
orpr
oces
sing
.
Like
lyev
iden
cefo
rpo
orpr
oces
sing
orcr
oss-
cont
amin
atio
n.
Imm
edia
tely
revi
ewfo
odha
ndlin
gas
wel
las
tem
pera
ture
and
time
cont
rols
.Tak
ein
vest
igat
ive
sam
ples
offo
od,f
ood
prep
arat
ion
envi
ronm
ent
and
food
hand
lers
.
Risk
will
incr
ease
prop
ortio
nalt
oth
ele
vels
dete
cted
and
the
likel
ihoo
dof
subs
eque
ntgr
owth
inth
eab
senc
eof
appr
opria
tele
vels
ofco
ntro
l.Re
view
hand
ling
asw
ella
spr
oces
sing
cont
rols
,es
peci
ally
ifth
ere
oppo
rtun
ities
for
grow
thof
stap
hylo
cocc
idur
ing
proc
essi
ngor
mat
urat
ion
ofth
epr
oduc
t.C
onsi
der
taki
ngin
vest
igat
ive
sam
ples
offo
od,f
ood
prep
arat
ion
envi
ronm
ent
and
food
hand
lers
.
N/A
Imm
edia
tein
vest
igat
ion
ofth
efo
odor
igin
,rev
iew
cook
ing
and
subs
eque
ntte
mpe
ratu
rean
dtim
eco
ntro
ls.T
ake
inve
stig
ativ
esa
mpl
esof
proc
esse
d(c
ooke
d)fo
od,r
awfo
odco
mpo
nent
s(p
artic
ular
lym
arin
epr
oduc
ts)
and
the
food
prep
arat
ion
envi
ronm
ent.
Risk
will
incr
ease
prop
ortio
nalt
ole
vels
dete
cted
.Fo
odm
ayno
tbe
com
eha
zard
ous
prov
ided
appr
opria
tele
vels
ofco
ntro
lare
appl
ied.
Con
side
rta
king
inve
stig
ativ
esa
mpl
esof
proc
esse
d(c
ooke
d)fo
ods,
raw
food
com
pone
nts
(par
ticul
arly
mar
ine
prod
ucts
)an
dth
efo
odpr
epar
atio
nen
viro
nmen
t.
N/A
Not
alls
trai
nsar
eca
pabl
eof
prod
ucin
gto
xin
and
caus
ing
dise
ase.
Con
firm
atio
nof
iden
tity,
typi
ng,p
atho
geni
city
(tox
inge
nede
tect
ion)
ofis
olat
es,C
onsi
der
ente
roto
xin
dete
ctio
nin
food
and
food
rem
nant
sfr
omca
ses
ofsu
spec
ted
food
pois
onin
g,or
whe
rehi
ghle
vels
(>10
5cf
u/g)
may
have
occu
rred
atan
yst
age
inth
efo
odch
ain.
Con
side
rre
ferr
alof
isol
ates
,pa
rtic
ular
lyw
here
asso
ciat
edw
ithou
tbre
akin
vest
igat
ions
orw
here
ther
eis
die
off
ofth
eba
cter
ium
durin
gst
orag
e.Re
gula
tion
(EC
)N
o.20
73/2
005
(as
amen
ded)
cont
ains
mic
robi
olog
ical
crite
riafo
rso
me
spec
ific
food
/co
agul
ase-
posi
tive
stap
hylo
cocc
icom
bina
tions
and
the
requ
irem
ents
tobe
com
plie
dw
ithby
FBO
s
Con
firm
atio
nof
iden
tity,
typi
ng
Con
side
rre
ferr
alof
isol
ates
,pa
rtic
ular
lyw
here
asso
ciat
edw
ithou
tbre
akin
vest
igat
ions
a,So
me
read
y-to
-eat
food
sar
eta
ken
asO
ffic
ialC
ontr
olsa
mpl
es,p
leas
ere
fer
toth
efo
odsa
fety
orpr
oces
shy
gien
ecr
iteria
inRe
gula
tion
(EC
)N
o.20
73/2
005
(as
amen
ded)
for
mic
robi
olog
ical
crite
riaan
dsa
mpl
ing
plan
s.b,
Regu
latio
n(E
C)
No.
178/
2002
,Art
icle
14Fo
odsa
fety
requ
irem
ents
.Not
appl
icab
leto
food
sfe
rmen
ted
with
Baci
llus
spp.
c,D
etec
ted
in25
gby
enric
hmen
tfo
rhi
ghris
kfo
ods
capa
ble
ofsu
ppor
ting
the
grow
thof
L.m
onoc
ytog
enes
such
asso
me
soft
ripen
edch
eese
s,sl
iced
mea
ts,s
mok
edfis
han
dpâ
tés.
d,N
otde
tect
edin
25g
byen
richm
ent
for
high
risk
food
sca
pabl
eof
supp
ortin
gth
egr
owth
ofL.
mon
ocyt
ogen
es.
G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 21
Haz
ard
Bac
illu
sce
reu
s
Bac
illu
ssp
p.(
oth
erp
ath
og
enic
Bac
illu
s)
Cam
pyl
ob
acte
rsp
p.
(th
erm
oto
lera
nt)
Clo
stri
diu
mp
erfr
ing
ens
Esch
eric
hia
coli
O15
7(a
nd
oth
erve
rocy
toto
xin
-p
rod
uci
ng
E.co
li(V
TEC
))
Foo
dty
pes
mo
sto
ften
asso
ciat
edw
ith
hu
man
infe
ctio
ns
Coo
ked
rice
(em
etic
synd
rom
e)C
ooke
dm
eats
,po
ultr
yan
dve
geta
bles
,so
ups,
spic
es(d
iarr
hoea
lsy
ndro
me)
Coo
ked
mea
ts,
poul
try
and
vege
tabl
es
Poul
try,
red
mea
t,m
ilkan
dda
irypr
oduc
tsm
ade
with
unpa
steu
rised
milk
orpo
st-
past
euris
atio
nco
ntam
inat
edm
ilk,u
ntre
ated
drin
king
wat
er
Coo
ked
mea
t,gr
avy
and
stoc
k
Und
erco
oked
beef
,milk
and
dairy
prod
ucts
mad
ew
ithun
past
euris
edm
ilkor
post
-pa
steu
risat
ion
cont
amin
ated
milk
,sal
adve
geta
bles
,un
trea
ted
drin
king
wat
er
Mic
rob
iolo
gic
alR
isk
Cat
ego
ry
Com
mer
cial
cate
ring
Com
mer
cial
cate
ring
Con
sum
ptio
nof
food
prep
ared
outs
ide
the
hom
eBa
rbec
ues
Con
sum
ptio
nof
untr
eate
dw
ater
/milk
onho
liday
(e.g
.far
m,
cott
age,
cara
van
site
)
Com
mer
cial
and
inst
itutio
nalc
ater
ing
Pre-
scho
ol/
nurs
erie
sZo
onot
ic(p
ettin
gfa
rms)
Dom
estic
hom
eIn
stitu
tiona
lset
tings
Con
sum
ptio
nof
untr
eate
dw
ater
/milk
onho
liday
(e.g
.far
m,
cott
age,
cara
van
site
)
Maj
or
rou
tes
of
tran
smis
sio
n
Food
born
e
Food
born
e
Food
born
eC
ross
-con
tam
inat
ion
Zoon
otic
Wat
erbo
rne
Food
born
e,N
on-f
oodb
orne
infe
ctio
n(i.
e.pe
rson
-to-
pers
onan
dan
tibio
tic-
asso
ciat
edin
fect
ions
occu
rin
elde
rly)
Food
born
eC
ross
-con
tam
inat
ion
Envi
ronm
enta
lexp
osur
ePe
rson
-to-
pers
onZo
onot
icW
ater
born
e
Kn
ow
nh
ost
risk
fact
ors
for
seve
rein
fect
ion
Unk
now
n
Unk
now
n
Age
(<5
yrs
or>6
0yr
s)Re
duce
dim
mun
est
atus
Ant
acid
trea
tmen
t
Mos
tpe
ople
are
prob
ably
susc
eptib
le
Age
(<5
yrs
(HU
S)or
>60
yrs
(TTP
))
Sym
pto
ms,
seve
rity
and
seq
uel
aea
Vom
iting
(em
etic
synd
rom
e)D
iarr
hoea
(dia
rrho
eals
yndr
ome)
Usu
ally
mild
and
shor
t-liv
ed,
last
s~
1da
y
Vom
iting
and
diar
rhoe
aU
sual
lym
ildan
dsh
ort-
lived
,las
ts~
1da
y
Dia
rrho
ea,h
eada
che,
abdo
min
alpa
in;
usua
llyla
sts
2-7
days
Irrita
ble
bow
elsy
ndro
me
(IBS)
mos
tco
mm
onse
quel
ae,r
eact
ive
arth
ritis
,G
uilla
in-B
arré
synd
rom
e
Dia
rrho
ea,a
bdom
inal
pain
;U
sual
lym
ildan
dsh
ort-
lived
,la
sts
~1
day,
but
diar
rhoe
alo
nger
and
mor
ese
vere
inel
derly
Deh
ydra
tion
inse
vere
case
s
Dia
rrho
ea,v
omiti
ng,a
bdom
inal
pain
,ha
emor
rhag
icco
litis
,las
ts2
wee
ksin
unco
mpl
icat
edca
ses,
can
befa
tal;
Hae
mol
ytic
Ura
emic
Synd
rom
e(H
US)
,Th
rom
botic
Thro
mbo
cyto
paen
icPu
rpur
a(T
TP)
No
.of
rep
ort
edh
um
anca
ses
inU
Kin
20
07
b
Man
yfo
odbo
rne
infe
ctio
nsar
eno
tre
port
ed
Man
yfo
odbo
rne
infe
ctio
nsar
eno
tre
port
ed
57,8
15
73 1,14
9
Tab
le3
.Maj
orfe
atur
esof
food
born
edi
seas
esdu
eto
sele
cted
path
ogen
s
/ / 2 2
List
eria
mo
no
cyto
gen
es
Salm
on
ella
spp
.(n
on
Typ
hi/
Para
typ
hi)
Shig
ella
spp
.
Stap
hyl
oco
ccu
sau
reu
san
do
ther
coag
ula
se-
po
siti
vest
aph
ylo
cocc
i
Vib
rio
cho
lera
e
Vib
rio
par
ahae
mo
lyti
cus
Hig
hris
kfo
ods,
such
assl
iced
mea
ts,p
âté,
soft
chee
se,
sand
wic
hes,
smok
edfis
h
Eggs
,pou
ltry,
pork
,bee
f,da
irypr
oduc
ts,s
eeds
,he
rbs,
sala
dve
geta
bles
,ch
ocol
ate
Sala
dve
geta
bles
Proc
esse
dm
eats
,po
ultr
y,fis
h,sh
ellfi
sh,a
ndda
irypr
oduc
ts.
Impo
rted
seaf
ood,
untr
eate
ddr
inki
ngw
ater
Impo
rted
seaf
ood
Hos
pita
lsan
dth
eco
mm
unity
Con
sum
ptio
nof
food
prep
ared
outs
ide
the
hom
eFo
reig
ntr
avel
Pre-
scho
ols
/nu
rser
ies
Inst
itutio
nals
ettin
gsFo
reig
ntr
avel
Com
mer
cial
and
inst
itutio
nalc
ater
ing
Fore
ign
trav
elpa
rtic
ular
lyto
the
Indi
ansu
bcon
tinen
t
Vario
us
Food
born
eC
ross
-con
tam
inat
ion
Food
born
eC
ross
-con
tam
inat
ion
Pers
on-t
o-pe
rson
Zoon
otic
Pers
on-t
o-pe
rson
Food
born
e
Food
born
eFo
odha
ndle
rsC
ross
-con
tam
inat
ion
Wat
erbo
rne
Food
born
e
Food
born
e
Age
(>60
yrs)
,Pr
egna
ncy
New
born
infa
nts
Imm
unos
uppr
essi
onA
ntac
idtr
eatm
ent
Redu
ced
imm
une
stat
us
Age
(<5
yrs)
Mos
tpe
ople
are
susc
eptib
le
Mos
tpe
ople
are
prob
ably
susc
eptib
le
Mos
tpe
ople
are
prob
ably
susc
eptib
le
Non
-inva
sive
:dia
rrho
ea,f
ever
,hea
dach
e,m
uscl
epa
inIn
vasi
ve:f
ever
and
seve
resy
stem
icin
fect
ions
poss
ible
(sep
ticae
mia
and
men
ingi
tis,a
ndm
isca
rria
ge).
Hig
hca
sefa
talit
yra
te.
Dia
rrho
ea,v
omiti
ng,a
bdom
inal
pain
,fe
ver;
last
sse
vera
lday
sto
3w
eeks
,and
inse
vere
case
sde
ath;
Sept
icae
mia
and
infla
mm
atio
nof
the
abdo
min
alw
all,
reac
tive
arth
ritis
Dia
rrho
ea,v
omiti
ng,b
acill
ary
dyse
nter
y;la
stav
erag
eof
4to
7da
ys;
HU
S,To
xic
meg
acol
on.
Nau
sea
and
vom
iting
,las
t1
–2
days
,m
aybe
very
acut
eA
bdom
inal
cram
psan
ddi
arrh
oea
Col
laps
ein
very
seve
reca
ses
Dia
rrho
ea,v
omiti
ng,s
ever
ede
-hyd
ratio
n,le
gcr
amps
Dia
rrho
ea
261
13,8
02
1,63
8c
Man
yfo
odbo
rne
into
xica
tions
are
not
repo
rted
47d
41
a,Th
eTa
ble
isno
tin
clus
ive
and
feat
ures
,oth
erth
anth
atde
scrib
edm
ayoc
cur
but
are
gene
rally
cons
ider
edun
com
mon
.b,
Dat
apr
ovid
edby
Hea
lthPr
otec
tion
Agen
cy,H
ealth
Prot
ectio
nSc
otla
nd,C
omm
unic
able
Dis
ease
Surv
eilla
nce
Cen
tre
Nor
ther
nIre
land
c,M
ost
case
sid
entif
ied
are
pers
on-t
o-pe
rson
d,A
llfo
reig
ntr
avel
asso
ciat
ed
G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 2 3
Hyg
ien
eIn
dic
ato
r
Ente
rob
acte
riac
eaea
Esch
eric
hia
colib
,c,d
Resu
lt(c
fu/g
)
>104
102
-≤1
04
<102
>102
20-
≤102
<20
Inte
rpre
tati
on
UN
SATI
SFAC
TORY
BORD
ERLI
NE
SATI
SFAC
TORY
UN
SATI
SFAC
TORY
BORD
ERLI
NE
SATI
SFAC
TORY
Co
mm
ent
Mem
bers
ofth
isgr
oup
occu
rin
the
envi
ronm
ent
asw
ella
sth
egu
tof
hum
ans
and
anim
als.
Thei
rpr
esen
ceat
thes
ele
vels
sugg
ests
anov
eral
lpoo
rge
nera
lhyg
iene
stat
usof
afo
odpr
oduc
t.Th
ese
bact
eria
are
not
relia
ble
indi
cato
rsof
cont
amin
atio
nby
faec
alpa
thog
ens
ina
food
.
Inte
rpre
tin
conj
unct
ion
with
test
resu
ltsfr
omot
her
mic
robi
olog
ical
para
met
ers
but
dete
ctio
nin
seve
ralf
oods
orot
her
area
sof
the
food
prod
uctio
nen
viro
nmen
tsh
ould
bein
vest
igat
ed.
Orig
inat
esfr
omth
ein
test
inal
trac
tof
man
and
anim
als
indi
catin
gco
ntam
inat
ion
and
grow
th(d
epen
ding
onth
ele
veld
etec
ted)
atso
me
stag
eof
the
proc
ess.
The
dete
ctio
nof
E.co
lica
nsi
gnify
aris
kth
atfa
ecal
path
ogen
sar
epr
esen
t.Re
sults
shou
ldbe
inte
rpre
ted
inco
njun
ctio
nw
ithte
stre
sults
from
othe
rm
icro
biol
ogic
alpa
ram
eter
s.Re
peat
edor
wid
espr
ead
dete
ctio
nin
seve
ralf
oods
oren
viro
nmen
tals
ites
high
light
san
incr
ease
dfo
odsa
fety
risk.
Alth
ough
E.co
lish
ould
not
bede
tect
edin
read
y-to
-eat
food
s,lo
wle
vels
may
occa
sion
ally
befo
und.
Repe
ated
orw
ides
prea
dde
tect
ion
inse
vera
lfoo
dsor
area
sof
the
food
prod
uctio
nen
viro
nmen
tsu
gges
tsan
incr
ease
dfo
odsa
fety
risk.
Like
lyC
ause
Poor
hygi
ene
due
toun
derc
ooki
ng,o
rcr
oss
cont
amin
atio
nfr
omra
wm
eat,
food
hand
lers
orfo
odco
ntac
tsu
rfac
esas
wel
las
poor
tem
pera
ture
and
time
cont
rol.
Poss
ible
evid
ence
ofpo
orhy
gien
edu
eto
unde
rcoo
king
,or
cros
sco
ntam
inat
ion
from
raw
mea
t,fo
odha
ndle
rsor
food
cont
act
surf
aces
asw
ella
spo
orte
mpe
ratu
rean
dtim
eco
ntro
l.
N/A
Poor
hygi
ene
due
toun
derc
ooki
ng,o
rcr
oss
cont
amin
atio
nfr
omra
wfo
odes
peci
ally
mea
t,fo
odha
ndle
rsor
food
cont
act
surf
aces
asw
ella
spo
orte
mpe
ratu
rean
dtim
eco
ntro
l.
Poss
ible
evid
ence
ofpo
orhy
gien
edu
eto
unde
rcoo
king
,or
cros
sco
ntam
inat
ion
from
raw
food
espe
cial
lym
eat,
food
hand
lers
orfo
odco
ntac
tsu
rfac
es,a
sw
ella
spo
orte
mpe
ratu
rean
dtim
eco
ntro
l.
N/A
Sug
ges
ted
Act
ion
s(N
ot
excl
usi
ve)
Revi
ewco
okin
gan
dal
lhyg
iene
proc
edur
esin
clud
ing
clea
ning
.Ta
kein
vest
igat
ive
sam
ples
offo
odan
dun
dert
ake
envi
ronm
enta
lm
onito
ring
offo
odpr
epar
atio
nen
viro
nmen
t.
Revi
ewco
okin
gan
dal
lhyg
iene
proc
edur
esin
clud
ing
clea
ning
.C
onsi
der
taki
ngin
vest
igat
ive
sam
ples
offo
odan
dth
efo
odpr
epar
atio
nen
viro
nmen
t.Ac
tion
shou
ldbe
prop
ortio
nalt
oth
ele
vels
dete
cted
.
Regu
latio
n(E
C)
No.
2073
/200
5(a
sam
ende
d)co
ntai
nsm
icro
biol
ogic
alcr
iteria
for
som
esp
ecifi
cfo
od/
Ente
roba
cter
iace
aeco
mbi
natio
nsan
dth
ere
quire
men
tsto
beco
mpl
ied
with
byFB
Os
Revi
ewco
okin
gan
dal
lhyg
iene
proc
edur
esin
clud
ing
clea
ning
.Ta
kein
vest
igat
ive
sam
ples
offo
odan
dun
dert
ake
envi
ronm
enta
lm
onito
ring
ofth
efo
odpr
epar
atio
nen
viro
nmen
t.
Revi
ewco
okin
gan
dal
lhyg
iene
proc
edur
esin
clud
ing
clea
ning
.C
onsi
der
taki
ngin
vest
igat
ive
sam
ples
offo
odan
dth
efo
odpr
epar
atio
nen
viro
nmen
t.Ac
tion
shou
ldbe
prop
ortio
nalt
ole
vels
dete
cted
.
Regu
latio
n(E
C)
No.
2073
/200
5(a
sam
ende
d)co
ntai
nsm
icro
biol
ogic
alcr
iteria
for
som
esp
ecifi
cfo
od/
E.co
lico
mbi
natio
nsan
dth
ere
quire
men
tsto
beco
mpl
ied
with
byFB
Os
Tab
le4
.Gui
danc
eon
the
inte
rpre
tatio
nof
resu
ltsfo
rhy
gien
ein
dica
tor
orga
nism
sin
read
y-to
-eat
food
spl
aced
onth
em
arke
t
/ / 2 4
List
eria
spp
.(n
ot
L.m
on
ocy
tog
enes
)>1
02
10-
≤10
2e
<10
f
UN
SATI
SFAC
TORY
BORD
ERLI
NE
SATI
SFAC
TORY
With
very
rare
exce
ptio
ns,s
peci
esot
her
than
L.m
onoc
ytog
enes
are
not
path
ogen
icto
hum
ans.
Det
ectio
nof
othe
rLi
ster
iasp
ecie
sat
this
leve
lsi
gnifi
esa
risk
that
L.m
onoc
ytog
enes
coul
dm
ultip
lyin
the
food
.Lis
teria
can
grow
,alb
eit
slow
ly,a
tre
frig
erat
ion
tem
pera
ture
s,an
dits
pres
ence
info
ods
with
anex
tend
edsh
elf
life
atth
isle
vels
ugge
sts
follo
w-u
pac
tion.
Rem
edia
lac
tion
shou
ldbe
take
nfo
rfo
ods
likel
yto
beco
nsum
edby
vuln
erab
legr
oups
inw
hom
the
risk
oflis
terio
sis
isin
crea
sed,
e.g.
food
sse
rved
inho
spita
ls
May
beco
me
apr
oble
mes
peci
ally
info
ods
capa
ble
ofsu
ppor
ting
grow
thof
List
eria
(see
abov
e).R
emed
iala
ctio
nsh
ould
beta
ken
for
food
sin
tend
edto
befe
dto
vuln
erab
legr
oups
inw
hom
the
risk
oflis
terio
sis
isin
crea
sed,
e.g.
food
sse
rved
inho
spita
ls.
Stro
ngev
iden
cefo
rpo
orpr
oces
sing
,or
poor
tem
pera
ture
cont
roli
nclu
ding
subo
ptim
alop
erat
ion
ofre
frig
erat
ors,
orov
erex
tens
ion
ofsh
elf
life.
Poss
ible
evid
ence
for
poor
proc
essi
ngor
poor
qual
ityra
wm
ater
ials
.Ind
icat
epr
oces
sha
sth
epo
tent
ialt
oal
low
cont
amin
atio
nby
L.m
onoc
ytog
enes
.
N/A
Revi
ewfa
ctor
yhy
gien
e(in
clud
ing
clea
ning
)to
geth
erw
ithte
mpe
ratu
rean
dsh
elf
life
cont
rols
.Ta
kein
vest
igat
ive
sam
ples
offo
odan
dth
efo
odpr
epar
atio
nen
viro
nmen
t,pa
rtic
ular
lypl
ant
and
mac
hine
ry.C
onsi
der
send
ing
isol
ates
for
refe
renc
ete
sts
Revi
ewqu
ality
ofra
wm
ater
ials
,fa
ctor
yhy
gien
e(in
clud
ing
clea
ning
),te
mpe
ratu
rean
dsh
elf
life
cont
rols
.Con
side
rta
king
inve
stig
ativ
esa
mpl
esof
food
and
the
food
prep
arat
ion
envi
ronm
ent,
part
icul
arly
plan
tan
dm
achi
nery
.C
onsi
der
send
ing
isol
ates
for
refe
renc
ete
sts.
Actio
nsh
ould
bepr
opor
tiona
lto
leve
lsde
tect
ed
a,Th
ecr
iterio
nlis
ted
for
Ente
roba
cter
iace
aedo
esno
tap
ply
tofr
esh
frui
tan
dsa
lad
vege
tabl
esor
food
that
cont
ains
fres
hfr
uit
and
vege
tabl
esas
ingr
edie
nts
e.g.
sand
wic
hes,
asth
ese
food
type
sca
nco
ntai
nhi
ghle
vels
ofEn
tero
bact
eria
ceae
aspa
rtof
thei
rno
rmal
mic
ro-f
lora
.The
crite
rion
does
not
appl
yto
chee
ses
ripen
edus
ing
acu
lture
ofH
afni
aal
veio
rPr
oteu
svu
lgar
is.
b,So
me
read
y-to
-eat
food
sar
eta
ken
asO
ffic
ialC
ontr
olsa
mpl
es,p
leas
ere
fer
toth
efo
odsa
fety
orpr
oces
shy
gien
ecr
iteria
inRe
gula
tion
(EC
)N
o.20
73/2
005
(as
amen
ded)
for
mic
robi
olog
ical
crite
riaan
dsa
mpl
ing
plan
s.c,
Acco
rdin
gto
Regu
latio
n(E
C)
No.
2073
/200
5(a
sam
ende
d)th
elim
itfo
rE.
coli
inliv
ebi
valv
em
ollu
scs
and
live
echi
node
rms,
tuni
cate
san
dga
stro
pods
plac
edon
the
mar
ket
durin
gth
eir
shel
f-lif
e(e
.g.r
awoy
ster
sin
tend
edto
beea
ten
raw
)is
230
MPN
/100
gfle
shan
din
tra-
valv
ular
liqui
d(f
ood
safe
tycr
iterio
n)us
ing
ISO
TS16
649-
3.d,
Crit
erio
ndo
esno
tap
ply
toch
eese
sm
ade
from
raw
milk
e,D
etec
ted
in25
gby
enric
hmen
tfo
rhi
ghris
kfo
ods
capa
ble
ofsu
ppor
ting
the
grow
thof
List
eria
spp.
such
asso
me
soft
ripen
edch
eese
,slic
edm
eats
,sm
oked
fish
and
pâté
f,N
otde
tect
edin
25g
byen
richm
ent
for
high
risk
food
sca
pabl
eof
supp
ortin
gth
egr
owth
ofLi
ster
iasp
p.
G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 2 5
Tab
le5
.Gui
danc
eon
the
inte
rpre
tatio
nof
resu
ltsfo
rae
robi
cco
lony
coun
tle
vels
inva
rious
read
y-to
-eat
food
san
dco
mpo
nent
spl
aced
onth
e
1 2 3 4 5 6 7 8 9 10 11 12 13
Foo
dC
ateg
ory
Am
bien
tst
able
cann
ed,b
ottle
d,ca
rton
edan
dpo
uche
dfo
ods
imm
edia
tely
afte
rre
mov
alfr
omco
ntai
ner
Food
sco
oked
imm
edia
tely
prio
rto
sale
orco
nsum
ptio
n
Coo
ked
food
sch
illed
but
with
min
imum
hand
ling
prio
rto
sale
orco
nsum
ptio
n;ca
nned
past
euris
edfo
ods
requ
iring
refr
iger
atio
n
Bake
ryan
dco
nfec
tione
rypr
oduc
tsw
ithou
tda
irycr
eam
,pow
dere
dfo
ods
Coo
ked
food
sch
illed
but
with
som
eha
ndlin
gpr
ior
tosa
leor
cons
umpt
ion
Non
-fer
men
ted
dairy
prod
ucts
and
dairy
dess
erts
,m
ayon
nais
ean
dm
ayon
nais
eba
sed
dres
sing
s,co
oked
sauc
es
Food
mix
edw
ithdr
essi
ngs,
dips
,pas
tes
Exte
nded
shel
flif
efo
odpr
oduc
tsre
quiri
ngre
frig
erat
ion
Raw
read
y-to
-eat
mea
tan
dfis
h,co
ldsm
oked
fish
Pres
erve
dfo
odpr
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/ / 2 8
Glossary
Aerobic – conditions in which oxygen is present
Anaerobic – conditions in which oxygen is absent.
Antimicrobial resistance - the ability of micro-organisms of certain species to survive or even to grow in the presenceof a given concentration of an antimicrobial agent, that is usually sufficient to inhibit or kill micro-organisms of thesame species (Directive 2003/99/EC60).
aw – the water activity (aw) of a food is a measure of availability of water for the metabolic activity and growth ofmicro-organisms.
Batch - a group or set of identifiable products obtained from a given process under practically identical circumstancesand produced in a given place within one defined production period (Regulation (EC) No. 2073/2005).
Borderline – test results that are not unsatisfactory but are also not satisfactory, are on the upper limit of acceptabilityand which indicate the potential for development of public health problems and of unacceptable risk.
Bacterial spores (endospores) - exist in a free state and are a tough, dormant form that are very resistant todesiccation, heat, and a variety of chemical and radiation treatments that are otherwise lethal to vegetative bacteria.The genera of Gram-positive bacteria, Bacillus and Clostridium, produce endospores which are released from a bacterial cell.
Competent authority - the central authority of a Member State competent for the organisation of official controls orany other authority to which that competence has been conferred (Regulation (EC) No. 882/2004).
Contamination – the presence or introduction of a hazard (Regulation (EC) No. 852/2004).
Disease – any change from a normal physiological state or function.
Emetic – causes vomiting.
Fermentation – conversion of a carbohydrate, such as sugar, by micro-organisms into an acid or an alcohol.
Flora - the bacteria and other micro-organisms that normally are found in a food.
Food business operator - the natural or legal persons responsible for ensuring that the requirements of food law aremet within the food business under their control (Regulation (EC) No. 178/2002).
Food examiner - a person who possesses the requisite qualifications and experience to carry out examinations for thepurposes of the Food Safety Act18.
Food safety criterion – criterion defining the acceptability of a product or a batch of foodstuff applicable to productsplaced on the market (Regulation (EC) No. 2073/2005).
Foodborne outbreak - an incidence, observed under given circumstances, of two or more human cases of the samedisease and/or infection, or a situation in which the observed number of cases exceeds the expected number andwhere the cases are linked, or are probably linked, to the same food source (Directive 2003/99/EC60).
Imported food – non-UK produced foods which are imported from other countries within or outside the EuropeanUnion. Import means the release for free circulation of food or the intention to release food for free circulation(Regulation (EC) No. 882/2004).
Microbiological criterion – criterion defining the acceptability of a product, a batch of foodstuffs or a process, based on the absence, presence or number of micro-organisms, and / or on the quantity of their toxins / metabolites,per unit(s) of mass, volume, area or batch (Regulation (EC) No. 2073/2005).
Modified atmosphere packaging (MAP) – removal of air from a food package and replacement with a strictlycontrolled gaseous mixture of carbon dioxide, oxygen, and/or nitrogen, and then hermetically sealed.
Morbidity – effect of disease.
Mortality – death as a result of disease.
Official control - any form of control that the competent authority or the Community performs for the verification ofcompliance with feed and food law, animal health and animal welfare rules (Regulation (EC) No. 882/2004).
G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 2 9
Pasteurisation – a form of heat treatment that kills vegetative pathogens and spoilage microorganisms in milk andother foods e.g. for milk a common pasteurisation process is 71.7°C for 15 seconds.
Pathogen – a micro-organism that has the capacity to cause disease, i.e. has the property of pathogenicity.
pH – the relative acidity or alkalinity of a food.
Potable water - water intended for drinking or use in food preparation.
Process hygiene criterion – criterion indicating the acceptable functioning of the production process. Such acriterion is not applicable to products placed on the market. It sets an indicative contamination value above whichcorrective actions are required in order to maintain the hygiene of the process in compliance with food law (Regulation(EC) No. 2073/2005).
Psychrotroph - a micro-organism that can grow at temperatures between -1°C and 5°C and have an optimum growthtemperature in the mesophilic range (20-30°C)
Ready-to-eat food – food intended by the producer or the manufacturer for direct human consumption without theneed for cooking or other processing effective to eliminate or reduce to an acceptable level micro-organisms ofconcern (Regulation (EC) No. 2073/2005).
Retail – the handling and/or processing of food and its storage at the point of sale or delivery to the final consumer,and includes distribution terminals, catering operations, factory canteens, institutional catering, restaurants and othersimilar food service operations, shops, supermarket distribution centres and wholesale outlets (Regulation (EC) No.178/2002).
Risk - a function of the probability of an adverse health effect and the severity of that effect, consequential to ahazard (Regulation (EC) No. 178/2002).
Risk assessment - a scientifically based process consisting of four steps: hazard identification, hazard characterisation,exposure assessment and risk characterisation (Regulation (EC) No. 178/2002).
Sample - a set composed of one or several units or a portion of matter selected by different means in a population orin an important quantity of matter, which is intended to provide information on a given characteristic of the studiedpopulation or matter and to provide a basis for a decision concerning the population or matter in question orconcerning the process which has produced it (Regulation (EC) No. 2073/2005).
Satisfactory – test results indicating good microbiological quality
Shelf-life – the period preceding the “Use by” or the minimum durability date (Directive 2000/13/EC61).
Sporulation – the process by which some bacteria are able to produce endospores to enhance their survival underadverse conditions (see bacterial spores).
Symptoms – manifestation or evidence of disease.
Thermotolerant – able to survive high temperatures.
Toxin – a poisonous substance with the capacity to cause disease.
Unsatisfactory – for pathogens, test results at levels which indicate a product that is potentially injurious to healthand/or unfit for human consumption and require immediate remedial action. For hygiene indicators, test results thatrequire remedial action.
Vegetative bacteria – a bacterial cell which is capable of actively growing; multiplication occurs by division of the cellinto two.
Viable - capable of living, developing, or germinating in favourable environmental conditions.
Vulnerable groups – population of persons more susceptible or more likely to develop foodborne disease, sometimesof greater severity; these groups include pregnant women, the elderly, young babies, children and people withweakened immune systems.
Zoonosis - any disease and/or infection which is naturally transmissible directly or indirectly between animals andhumans (Directive 2003/99/EC60).
Zoonotic agent – any virus, bacterium, fungus, parasite or other biological entity which is likely to cause a zoonosis(Directive 2003/99/EC60).
/ / 3 0
References
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Mitchell, R.T. Practical Microbiological Risk Analysis. How to Assess, Manage and Communicate Microbiological Risks inFoods. Chandos Publishing (Oxford) Limited, Oxford, 2000.
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G u i d e l i n e s f o r A s s e s s i n g t h e M i c r o b i o l o g i c a l S a f e t y o f R e a d y - t o - E a t F o o d s P l a c e d o n t h e M a r k e t / / 31
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