Service of Raw, Rare and Low Temperature Cooked Meats An advisory paper from the National Food Hygiene Focus Group to assist in assuring consistency of enforcement – January 2015 Introduction 1.1 During 2014 the Food Hygiene Focus Group (FHFG) recognised that the preparation and sale of raw, rare and low temperature cooked foods was an area causing enforcement officers significant difficulty in taking a consistent approach. This paper looks specifically at meat preparation but some of the issues considered will be relevant to other foods. Sources of advice that appeared to be conflicting included FSA Board Paper – Our Approach to “Risky” Foods November 2014 ACMSF Report – April 2014 – Raw, Rare & Low Temperature (RRLT) food ACMSF Report – 2007 - The Safe Cooking of Burgers E. coli & Cross Contamination Guidance July 2014 Davy’s v Westminster judgement July 2013 John Barr Incident Report (“Pennington 1”) John Tudor Incident Report (“Pennington2”) 1.2 The Group was concerned about inconsistent enforcement but also about a possible reluctance to enforce in situations where enforcement action was critical to protecting the public health. Therefore, while recognising the need for further research to be carried out in areas such as cooking at core temperatures below 60°C, it was agreed on 1st October 2014 that in the interests of consistency and public protection, enforcement guidance was necessary immediately. Subsequently the Food Standards Agency (FSA) announced its paper for the 5 th November Board Meeting entitled “Our Approach to “Risky” Foods”. 1.3 FHFG has examined available expert and other relevant opinions. In doing so it has taken account of the strategic roles FSA proposes for itself in relation to ensuring only safe food is placed on the market and relating to consumers taking greater responsibility for their own food risks management. This guidance document is specifically for enforcement officers. It is not legally binding but seeks to clarify relevant considerations and it suggests common enforcement approaches. Summary 2.1 There is much evidence that many pathogenic bacteria exist in raw meat and the E. coli & Cross Contamination Guidance (June 2014) specifically makes clear the risks from E. coli in raw foods. Enforcement officers should generally regard raw or undercooked meat as unsafe food unless it has been subject to an acceptable, validated process that has made the food safe (the searing of undamaged red meat muscle for example, is a generally accepted method to produce safe rare steak). In the absence of a satisfactory, validated safe method, enforcement action must be taken to protect public health. 2.2 Where an enforcement officer is faced with conflicting expert advice the FHFG suggests it is reasonable for the officer to express in writing why a safe method is not considered to be fully validated but also that enforcement action is not being taken unless at some time in the future more conclusive evidence undermining the validation becomes available. 2.3 For example, where a supplier of raw meat claims his product is safe to eat because his herd has been tested for many years and has always been free of pathogens, the enforcement officer has a dilemma. On the one hand, although the presence of pathogens makes food unsafe, there is no clear definition of what constitutes an unacceptable risk of pathogens being present. Elizabeth Roscoe, District Judge, Westminster Magistrates’ Court, ruled that in this example the meat supplier’s negative test results satisfy a critical limit which assures the prevention, elimination or reduction of identified hazards to an acceptable extent. Additionally, the FSA has stated they are moving towards allowing consumers to take greater responsibility for managing the food risks that are personal to them. On the other hand, negative test results do not mean the herd will be immune in the future to pathogens, including E. coli, carried by wild animals and birds. Therefore, without a further process, a risk from pathogens that is not acceptable to public health professionals remains. Additionally, the general public at present does not have enough knowledge to make adequately informed decisions about eating raw meat safely. FHFG disagrees with the Davy’s v Westminster judgement but without more conclusive evidence, it recommends in these circumstances the course of action stated at 2.2. In circumstances where there is no supported validation, enforcement action must be taken. The science 3.1 The expert opinions of witnesses involved in legal proceedings require consideration but the most important source of scientific opinion relating to RRLT food remains the Government’s Advisory Committee on the Microbiological Safety of Food (ACMSF). It reported on RRLT food formally in April 2014. 3.2 The Report states that the generally quoted time/temperature combinations of 10 minutes at 65°C and 45 minutes at 60°C do not adequately take account of E coli O157 and that for foods where that organism may be present, time/temperature combinations would need to be 14 minutes at 65°C and 93 minutes at 60°C. It further reports that below 60°C there are uncertainties associated with the boundary for heat inactivation of several important strains of bacteria. Additionally, the potential for growth of C. perfringens would indicate that heating profiles must move rapidly through this temperature zone (temperatures approaching a safe core temperature), to avoid the risk associated with the growth of this organism. ACMSF concludes “there is currently no scientific data to support (core) cooking temperatures less than 60°C but work in this area is on-going”. 3.3 In relation to “sear & shave” the report states “In this approach the outside surfaces of whole muscle cuts of meat are briefly heated to a high temperature (seared), while the deeper tissues remain essentially raw (this may be considered to be very rare “cooking”). The seared surfaces are separated from the uncooked inner tissues, which are used to produce raw/rare products. The reported advantage of this method of preparation is that the most heavily microbiologically contaminated part of any whole muscle cut of meat, i.e. the outer surface is not consumed, but the inner parts, considered to contain minimal contamination can be safely consumed. The sear and shave procedure is an attempt to produce a raw/rare product, that has a reduced microbiological risk to the consumer. There are a number of points to consider in relation to sear and shave. Whilst the procedure will undoubtedly reduce microbiological numbers on the outside of whole muscle cuts of meat, it will have little effect on any organisms that are internalised. Little information can be collected on the internal contamination of whole muscle cuts. There is some information that would indicate slaughter practice and pre-cook practices such as tenderisation, could introduce contamination into the centre of muscle tissue. More information is required on the internal contamination of whole muscle cuts before the microbiological risks of this procedure can be fully assessed. The effectiveness of “sear and shave” is in part very dependent on the hygiene standards achieved during the post sear dissection of the seared surfaces. Removal of seared areas would need to be carried out very carefully under strictly controlled conditions using clean/sterilised knives/boards/ surfaces/equipment, with effective means of preventing cross-contamination of the shaved meat.” 3.4 In relation to sous vide and similar, the report states “Sous Vide cooking is a particular type of low temperature cooking process in which food is sealed within a gas impermeable plastic bag, from which most of the air is removed to pull the bag tightly around the food item. The product is then heat treated within a temperature controlled water bath for a specified (relatively long) period of time. The removal of air from the bag ensures good heat transfer to the product from the water and a faster heating up time, while the sealed pack reduces the risks of post cooking recontamination. As sous vide cooking uses low temperatures, it involves a number of the previously noted risks associated with bacterial survival and/or growth. In addition, this method involves storage under low oxygen conditions, which means that Food Standards Agency guidance on the 'safety and shelf-life of vacuum and modified atmosphere packed chilled foods with respect to non-proteolytic Clostridium botulinum, should be considered in relation to storage temperature, product shelf life, and safety of these products. Relevant legislation 4.1 The implications of the following laws are relevant to measures required to control these RRLT issues. Regulation (EC) No 852/2004 Article 5 – requirement to have and implement an appropriate documented food safety management system. In particular, paragraph 2(c) requires that food business operators (FBOs) “establish critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards”. Regulation (EC) 178/2002 Article 14, paragraph 1 states “food shall not be placed on the market if it is unsafe”. Recital 10 of Regulation (EC) 178/2002 also states "it is necessary to adopt measures aimed at guaranteeing that unsafe food is not placed on the market and at ensuring that systems exist to identify and respond to food safety problems in order to ... protect human health". E. coli & Cross Contamination Guidance (as amended June 2014) 5.1 This revised guidance states “E. coli O157 is a hazard that needs to be controlled through the business' food safety management system. To help businesses comply with this requirement the guidance clarifies: the circumstances in which E. coli O157 cross-contamination hazards should be considered, the control measures that can be applied to control cross-contamination with E. coli O157, and that if such controls fail, there is an imminent risk to consumers with potentially severe consequences.” 5.2 It follows that at premises where that Guidance applies, if contamination by raw meat has potentially severe consequences then the consumption of raw red meat that has not undergone treatment such as cooking, potentially has severe consequences. The Davy’s v Westminster judgement 6.1 This judgement related to the requirements made in a Hygiene Improvement Notice (HIN) and was heard in the Westminster Magistrates Court. It stated “In conclusion, I am satisfied that, on the balance of probabilities, the HIN was not justified in respect of Davy’s actual preparation of hamburgers to be consumed cooked rare or medium rare. I find that they were entitled to rely upon the quality of the raw mince supplied to them by DR [the supplier of vacuum packed raw beef mince], and that, having conducted checks and seen quality control documentation from DR, that could be a CCP. Their own inspection of the meat delivered was also a CCP. The method of storing and preparing the hamburgers was acceptable. […………] Accordingly, I modify the HIN by deleting paragraph 2.1 “There were inadequate measures in place to control risk related to pathogenic microorganisms and their toxins in burgers served medium rare or rare.” 6.2 The judgement considers several factors in reaching this conclusion but amongst the most pertinent are the following. “It is accepted that the only way to guarantee elimination of Ecoli in meat is by cooking the produce to a certain temperature for a required time. (I am aware that that would not eliminate post cooking contamination). This, of course, is possible for burgers and meat generally, but it is not possible if one serves the meat rare. Does that mean that the meat cannot be served rare? That is not suggested by the Respondent and, I suspect, would not be acceptable within the greater community. If the meat can be served rare and the hazard, therefore, cannot be guaranteed to be eliminated, presumably it must be reduced to an acceptable level. I am told that no level of Ecoli 0157 is acceptable because of the potential severity of the danger it carries. If it is permissible to serve meat (including hamburgers) rare then it must be that there is, (within the context of serving rare beef) a permissible process of reduction of Ecoli 0157 to an acceptable level.” “There was a slight issue with the standards of DR. The issue was that Professor Pennington accepted that DR sell high quality meat and have achieved and maintained as high standards as any in the UK, but his view was that they could not guarantee that their product was Ecoli free. His opinion, therefore, was that he could only say that their systems had not been “found wanting”, whereas Dr Dinsdale was of the opinion that the satisfactory microbiological results of its checks showed that the system worked. Again there was no substantial difference between the experts as both agreed that DR operated to very high standards and both agreed that total elimination of Ecoli or Ecoli O157 could not be guaranteed.” “The central issue here is whether or not rare burgers should be made available to the public. Apart from meat, there are other foodstuffs that have a comparatively high risk of being contaminated with Ecoli. Sprouting vegetables are one and raw milk cheeses are another. Salads and herbs also are a risk. These are increasingly popular foods in this country.” “There is a balance to be struck between ensuring the safety of the public and allowing them the freedom of choice that they would wish and have a right to expect. This case appears to me to be an issue of whether or not a restaurant can realistically supply rare burgers to those who request them even though there will inevitably be a risk and even if the risk is slight. The potential for harm in this case is small, although the danger of that risk could be severe. Accordingly, the risk is not slight. [……] The issue of the Critical Control Points (CCP) in HACCP are fundamental. But it is not necessarily the case that cooking is inevitably a CCP. Usually it will be, and even here it is, but that does not mean that the CCP has to result in the burgers being cooked medium or well.” 6.3 The FHFG believes that in making this judgement an assumption was made that because consumers are free to choose the consumption of raw red meat in their homes they have a similar right to do so in a food business. Although the FHFG is not certain about the application of human rights to European food law it does not support this opinion. The position taken by the Food Standards Agency 7.1 The FSA needs to take account of direction given by the EU concerning EU legislation, advice from ACMSF concerning scientific considerations and opinions expressed by members of the public. Like FHFG, it recognises that the cautionary advice from ACMSF based upon the requirement for further research, while sound, is hampering the issue of clear guidance. 7.2 In its paper Our Approach to “Risky” Foods (November 2014), FSA states it will be instrumental in “both ensuring food businesses step up to their responsibility to ensure the food they provide is safe and what it says it is, and enabling informed choice by consumers and allowing them to take greater responsibility for managing the food risks that are personal to them and that they can affect”. At Section 5 “Discussion”, FSA outlines its thoughts about the relevant science, legislation and attitudes (the same issues considered in this paper) and in some cases makes specific reference to raw and undercooked meat. It also indicates it will require time before validated statutory guidance can be issued to enforcement officers. 7.3 This FHFG guidance will be subject to future developments announced by FSA but in the interim, FHFG has created this guidance for reasons previously stated. FHFG Recommendations 8.1 The Davy’s v Westminster judgement was made in a lower court and is not binding. The judgement appears to have been made based upon two main arguments. i. The final consumer is entitled to be supplied at a restaurant with raw or rare meat if they choose, as they are entitled to be served with salads, oysters and unpasteurised milk etc. which also have intrinsic risks. ii. Good hygiene at a raw meat cutting plant and a record of microbiological testing free of positive VTEC results constitutes sufficient reason for a restaurant operator to regard the supply of raw minced beef as ready to eat food. 8.2 FHFG considers both of these arguments to be untenable and makes its recommendations mainly on the basis of scientific advice but with some important caveats to the ACMSF advice. 8.3 Salads are (or can be) washed, oysters are depurated under bespoke legislation and the supply of unpasteurised milk is controlled under bespoke legislation. These controls are believed by experts to bring risks to an acceptable level and comparisons with raw red meat do not appear valid. Professor Pennington and other experts have said raw red meat, no matter how good the supplier’s previous record in relation to live animal tests, food poisoning cases etc., cannot be considered as safe without a validated step that brings risk to an acceptable level. 8.4 FHFG is unaware of any other challenges to European food laws made on the basis of human rights. It believes that Regulation (EC) No 852/2004 Article 5 and Regulation (EC) 178/2002 Article 14 are not subject to any human rights enjoyed by the consumer. It also believes that if competent experts can't all agree on this matter, then the public cannot be expected to make reasonable choices by themselves. 8.5 Furthermore, if a consenting customer was ill from eating raw steak the food business operator would still be guilty of selling food that was unsafe. This re-visits the question of probability and acceptability of risk from VTEC in raw red meat and it raises what would constitute a satisfactory due diligence defence. There must be credible evidence that somebody has done what is necessary to make food as safe as is reasonably possible. Control methods require validations that are acceptable to the local Environmental Health section (subject to appeal) and this paper gives advice on how officers should consider validations that are not absolute. 8.6 One consultant involved with the Davey’s business (and its appeal against the HIN) has put forward the following opinion. “The mince used to produce hamburgers by Davy’s is obtained from an EC approved establishment, (i.e. approved and supervised by the FSA), which has an exemplary record, in terms of the microbiological quality of its products and the production environment. The mince is made from prime cuts and complies with the microbiological criteria for mince intended to be eaten raw or undercooked, under Regulation EC 2073/2005: there is no higher regulatory standard.” FHFG is of the opinion that levels of VTEC in mince consumed in a food business is not within the scope of EC 2073/2005 and it would again point instead to Regulation (EC) No 852/2004 Article 5 and Regulation (EC) 178/2002. 8.7 In all cases the FBO needs to supply a documented safe method with credible validation. In doing so, the FBO may need to make a judgement based upon current scientific data as well as the statutory guidance on interpretation of the law. Given the recommendations from ACMSF for further research, the scientific support for what appears on the face of it to be a reasonable judgement may not be absolute. Where an enforcement officer is faced with conflicting expert advice, or persuasive evidence that is not absolute, the FHFG suggests it is reasonable for the officer to express in writing why a safe method is not considered to be fully validated but also that enforcement action is not being taken unless at some time in the future more conclusive evidence undermining the validation becomes available. 8.8 Having regard to the above matters, FHFG recommends, in order to aid consistency, the approaches to RRLT foods in Annex 1. A graduated or otherwise appropriate enforcement approach should be made under an Authority’s existing Enforcement Policy. Annex 1 Sear & Shave (or similar) A food business operator should take account of the cautionary comments made by The Government’s Advisory Committee on the Microbiological Safety of Food (ACMSF) concerning the ability of pathogens to penetrate red meat (muscle) to some extent. If, despite this risk, a food business operator chooses to utilise “sear and shave” the following is recommended. Whole pieces of red meat muscle (steak) can be served rare providing all outside surfaces are effectively seared or similar. This is because bacteria do not penetrate into red meat muscle providing it is in good condition (free of punctures, tears, excessive connective tissue etc.). Processes to remove bacteria from the external surfaces include searing all surfaces on a hot griddle or pan, or plunging the meat into boiling water for a time that achieves the same effect. External surfaces may then be hygienically sliced off if required to leave meat that is safe to serve rare or even in the Carparccio style. Post-searing, it is essential that the ready to eat meat is protected from contamination in accordance with the E. coli control guidance. N.B. This particular safe method is not acceptable for poultry meat where bacteria enters into the muscle. Therefore an adequate time/temperature combination is required at the centre of a piece of poultry meat. Regulation (EC) 852/2004, Article 5 Rare/Medium-Rare Cooked Muscle Cuts A food business operator should take account of the cautionary comments made by The Government’s Advisory Committee on the Microbiological Safety of Food (ACMSF) concerning the ability of pathogens to penetrate red meat (muscle) to some extent. If, despite this risk, a food business operator chooses to serve rare/medium-rare cooked muscle cuts, the following precautions should be taken in order to comply with Regulation (EC) 852/2004 Article 5: Only beef or lamb should be served rare. The internal muscle of e.g. chicken, turkey, duck or game may be contaminated with e.g. salmonella or campylobacter so should never be served rare, nor should pork due to the possibility of parasites or Hepatitis E infection being present in the muscle. Meat deliveries should be checked on receipt to ensure that they are in good condition and have been protected from contamination during transportation/delivery/storage. There should be no signs of damage or penetration of the meat surface that could introduce contamination from the outer layers to the centre of the muscle block. Only whole muscle cuts should be used. Do not inject, mechanically tenderise or score raw meat as this may introduce contamination. Probing raw meat for temperature (even with a sterile probe) may also introduce contamination from the outer layers into the centre of the meat. Cooking times and temperatures should be adequate to kill vegetative bacteria on the outer surfaces of the meat. The Meat and Livestock Commission, in their “Recipes for Love”, suggest that a standard cooking time for a rare beef steak which is 2cms thick would be about two and a half minutes per side. A change of colour would indicate if this has occurred. Measures (aseptic) to prevent post cooking cross contamination from raw to cooked meat will be needed particularly where several pieces of meat are being cooked on the same equipment e.g. a barbecue, with different start and finish times. It is recommended that rare meat is served to the customer straight after being cooked rare, in order to minimise risks of re-contamination. Staff must be trained to follow the critical control points relevant to their work. Regulation (EC) 852/2004, Article 5 Lightly cooked foods This advice relates to the cooking of all meats including game but is especially important for offal and similar. The Government’s Advisory Committee on the Microbiological Safety of Food (ACMSF) states that the generally quoted time/temperature combinations of 10 minutes at 65°C and 45 minutes at 60°C do not adequately take account of E coli O157 and that for foods where that organism may be present, time/temperature combinations would need to be 14 minutes at 65°C and 93 minutes at 60°C. It also states that below 60°C there are uncertainties associated with the boundary for heat inactivation of several important strains of bacteria. Furthermore it points to the importance of the “come up time”, stating “The potential for growth of C. perfringens would indicate that heating profiles must move rapidly through this [the “unsafe”] temperature zone, to avoid the risk associated with the growth of this organism”. There is currently no scientific data to support (core) cooking temperatures less than 60°C but work in this area is on-going. A food business operator should take account of the above ACMSF advice relating to the uncertainty about what makes raw meat safe. The validation of the time/temperature combinations below precedes the current ACMSF advice. Despite this uncertainty however, if lightly cooked foods are processed at least to the level described by the following pasteurisation time/temperature combinations, this will be recognised as a safe method for the purpose of Regulation (EC) 852/2004, Article 5. 60°C – this core temperature maintained for at least 45 mins 65°C – this core temperature maintained for at least 10 mins 70°C – this core temperature maintained for at least 2 mins 75°C – this core temperature maintained for at least 30secs 80°C – this core temperature maintained for at least 6 secs Challenge testing Some private laboratories offer “challenge testing” to establish the critical limit required for a process to assure that food is safe (for example, the amount of cooking required to achieve pasteurisation). The challenge involves determining how much of a reduction is required in the initial number of pathogens originally present in the food to achieve a final number of those bacteria that can be considered as negligible. A ten-fold decrease is called one log reduction and The Government’s Advisory Committee on the Microbiological Safety of Food (ACMSF) requires a 6-log reduction but some laboratories make a challenge test on a process assuming that a 4-log reduction is safe. Different pathogenic organisms will need different amounts of heat treatment to kill them and ACMSF states that E coli requires more heat treatment (a higher Z value) than Salmonella for example. The effectiveness of the challenge will depend not only upon the validation of the log reduction chosen but also the initial dose of (pathogen) contamination present in the food. E. coli outbreaks related to meat have often involved “super-shedder” cattle, where the initial contamination of E. coli on the meat (before heat treatment) has been very high. If a food business operator relies upon information in respect of microbiological challenge testing or microbiological cattle herd testing, it is possible that a court will uphold the evidence of another witness whose expert opinion is that a higher level of challenge is required. It is very important that a food business operator ensures that any validation of a safe method is agreed with the Environmental Health section of the Local Authority. Sous vide A sous vide method needs to be an acceptably validated safe method. A person utilising sous vide will need to write down what the method is (e.g. whether the raw duck for example starts at refrigerator or room temperature, the approximate size and number of pieces being cooked in the batch, the vacuum quality achieved in the packaging, the temperature of the water bath, how it is established that an acceptable core temperature is reached and maintained, the time for which the pieces cook after reaching an acceptable core temperature and the actual core temperature that was maintained). Verification can be carried out each time a batch is cooked, or if the pieces are always uniform you may be able to use a validated “prove-it” record. To create a prove-it record you will need to write down the method, the date you made the prove-it check, the time for which an acceptable temperature was maintained and the actual temperature that was maintained at the centre of the food until cooking was complete. The prove-it should be verified at regular intervals, e.g. every 2 months. Regulation (EC) 852/2004, Article 5 Fish intended to be eaten raw or lightly cooked Raw fish intended to be eaten raw or almost raw, such as raw marinated fish used to make Sashimi or Sushi, will need to be wholly sourced from suppliers that have frozen the fish to –20°C for 24 hours or is derived from farmed fish or from a fishing ground that epidemiological data indicates is free from the presence of parasites and is authorised for sale without prior freezing by the competent authority. Fish is deemed to be “almost raw” where the core temperature is below 60°C. Regulation (EC) 1276/2011 amending Annex III, Section VIII, Chapter II of Regulation No. 853/2004, Part D