The Pennington Group

Report on the circumstances leading to the 1996 outbreak of infection with E.coli 0157 in Central Scotland, the implications for food safety and the lessons to be learned.

Chapter 7 Practices and Hygiene in Meat Products Premises and Butchers' Shops

7.1 The potential for cross-contamination of foods points to the critical nature of meat production and butchers' premises in the food chain. Even with measures taken earlier in the chain to help prevent contamination, it is probably inevitable that some meat will enter the premises contaminated with E.coli O157. All raw meat, therefore, needs to be treated as though it is potentially contaminated and appropriate handling and hygiene standards adopted.

7.2 As indicated in Chapter 4 of this report, we accept fully that HACCP should be the universal approach through which the hazards associated with food production should be tackled, but the need to renegotiate the EU directives makes this a longer-term aim. In the meantime, we have a number of reservations about the implementability and enforceability in the short term of even those of the HACCP principles that are currently set out in our domestic legislation. This chapter of the report is intended to explore and explain the issues associated with these premises in that context. It discusses our interim recommendations in more detail and sets out the further consideration we have given to the issues and our final recommendations.

The Regulatory Position

7.3 The Food Safety Act 1990 provides a full range of powers to regulate food businesses. It does so both directly (by creating specific offences or powers - for example the offence of rendering food injurious to health and powers to seize food) and indirectly by empowering Ministers to regulate by subordinate legislation.

7.4 Food safety is also the subject of European Community legislation. The main relevant directives are:-

Council Directive 64/433: on fresh meat;
Council Directive 94/65: on minced meat and meat preparations;
Council Directive 79/99: on health problems affecting production and marketing of meat products etc, which lays down more specific rules applicable to certain businesses; and
Council Directive 93/43: on the hygiene of foodstuffs and which lays down a number of general rules.

7.5 The first 3 of these directives require premises to be either licensed or approved and both licences and approvals may be revoked. The last requires registration of premises, which is given as of right and cannot be revoked.

7.6 EU Directives may constrain the scope for further domestic legislation or may provide an option for it. Directive 93/43 provides such an option, although Community approval (or at least acquiescence) is required before domestic measures may be brought into force.

7.7 The Meat Products (Hygiene) Regulations 1994, made under the 1990 Act, apply to certain categories of premises producing meat products. (This is in addition to the application to the retail part of the premises of the Food Safety (General Food Hygiene) Regulations 1995.) The 1994 Regulations contain provisions requiring the approval of premises and prescriptive conditions relating to the construction and layout of premises, facilities provided within the premises, general conditions of hygiene and requiring the separation of raw and cooked products either by space or time. Some of the main HACCP principles are, therefore, required to be implemented by premises covered by these regulations.

7.8 The 1994 Regulations do not however apply to certain premises supplying the 'final consumer'. Evidence we heard showed the position on the application of these regulations to be complex and confusing to enforcement agencies and the trade. As well as the regulations themselves, a statutory code of practice, guidance notes on enforcement from Government and 2 further explanatory letters to enforcement authorities deal with their application. It is also clear that the Government guidance goes beyond the specific terms of the regulations in certain respects: for instance it includes revised guidance "to define "take-away" in a realistic and sensible way that does not compromise public health"; and it introduces a threshold of 1 tonne/50% of the production intended for immediate consumption which notably is not set out in the regulations. Food authorities have to have regard to any Codes of Recommended Practice and Guidance. On this basis, businesses have claimed, and food authorities have accepted, exemption from the 1994 Regulations.

7.9 Premises not covered by the 1994 Regulations are covered by the 1995 Regulations - also made under the 1990 Act and giving effect in the UK to the provisions of EU Directive 93/43. These regulations are less prescriptive - although embracing more of the HACCP principles. They require no approval or licensing and impose general requirements relating to structural matters, transport, equipment and food handling and storage. They require only that the layout, design, construction and size of the premises should permit good food hygiene practices, including protection against cross-contamination.

Interim Report and Priority Recommendations

7.10 In producing our interim report and priority recommendations, we took the view that differentiating between premises covered by the 1994 Regulations and those, particularly high risk premises, covered only by the (less prescriptive) 1995 Regulations was inappropriate. We were concerned about the enforceability, under the latter regulations, of measures we felt necessary to ensure food safety. We therefore recommended measures to strengthen the requirements to ensure food safety in premises covered only by the 1995 Regulations, and to promote 'equivalence' in the level of prescription between the two sets of regulations.

7.11 Some of these recommendations have generated a great deal of discussion and debate-notably those relating to requirements for the separation of raw and cooked meat products and the proposal for the introduction of selective licensing arrangements for butchers and producers who are handling raw and cooked meats, whether at retail, preparation or wholesale. They have been the subject of consultation, in Scotland, with a wide range of bodies and organisations. The Secretary of State asked the Meat and Livestock Commission (MLC) to offer advice on their practicalities. A summary of its main findings, in a report dated February 1997, is at Annex V. We had detailed, and very constructive, discussions with MLC representatives and others on these issues in the lead up to production of this report and took account of these discussions and of the responses to the consultation exercise in producing our final recommendations.

The Timetable for the Implementation of HACCP

7.12 Strong arguments were put to us to the effect that the effort and resources that would be required to implement our selective licensing proposal (incorporating other prescriptive requirements) would be put to better use in promoting and assisting the faster implementation of HACCP. To an extent, we accept that. It is quite clear that the 'light touch' approach to the implementation of existing hazard analysis and other HACCP principles should now be brought to an end and enforcement effort stepped up. However this is clear evidence that even the first step in the process - the legal requirement to carry out a hazard analysis - is not being met adequately at present. Findings by the MLC suggest a significant number of butchers (including 40% of those manufacturing and wholesaling cooked meat products) have not carried out such an analysis. There is, therefore, substantial scope to improve implementation and enforcement even of the measures covered by the existing regulations.

7.13 However, even with the will to implement and enforce, this is likely to place very high demands on the resources of EHOs. Leaving aside the question of enforcement issues (discussed in Chapter 9), there is an enormous task to be done training and educating food handlers in HACCP principles. The task is not, of course, one solely for EHOs. There are many in both the public and private sectors who can, and should, contribute to that process. We welcome, for example, the initiative taken by the Scottish Food Co-ordinating Committee and Scottish Enterprise Tayside in producing the document "Risk Assessment for the Smaller Food Business".

7.14 One suggestion made to us, which it might be worth taking forward, is that some form of "generic" HACCP could be produced for butchers. We are also aware, however, of concerns about butchers purchasing "off the shelf" HACCPs. To be effective, HACCPs need not only to be tailored to meet the requirements of individual operations and premises, they also need to be understood and the analytical findings "owned" by the management and staff of the business concerned. Moreover they need to be implemented and reviewed on an on-going basis, rather than regarded as a periodic, one-off exercise.

7.15 As highlighted in Chapter 4, the principal question for us was whether it would be possible to reach a satisfactory position in terms of the implementation of HACCP within a reasonable timetable bearing in mind concerns about E.coli O157 and food safety issues generally. The MLC's view is that, with substantial additional resources, that position could be reached within 18 months to 2 years. That seems to us to be over-optimistic. Most others from whom we took advice, including EHOs themselves and bodies representing their interests, suggest that even with the application of additional resources the timetable for adequate implementation is likely to be 5 years or more. We consider that assessment more realistic in light of the need to renegotiate directives, our perceptions of the current state of awareness 2 years after the introduction of some of the HACCP principles and the further work needed to take forward implementation of these principles to an acceptable standard across the industry. The majority of butchers do not have a documented hazard analysis and control system based on HACCP principles. We heard suggestions, from a number of sources, that butchers, particularly those running small operations, might actually welcome being told precisely what is required of them rather than being left to interpret for themselves the philosophy and principles of HACCP.

7.16 Bearing all of the above in mind, we concluded that our interim finding - of the need for prescriptive measures to fill the gap between the current position and the stage of adequate implementation of HACCP - was correct. We therefore proceeded to examine what the options might be for achieving that.

Options for Interim Action

7.17 Directive 93/43 encourages Member States to develop industry guides to good hygiene practice. Enforcement authorities are required to give due consideration to such guides in securing compliance with the Directive. That obligation is reflected in Regulation 8(2)(c) of the 1995 Regulations. There is an advisory panel on industry guides in place and industry guides for various sectors of the food industry either in place or under preparation. It was suggested, therefore, that the issues of concern to us could be covered in an industry guide for butchers which could be prepared, issued and implemented promptly - hopefully with the full support of industry associations and the relevant Government departments.

7.18 We see the benefits to be gained from the production of such an industry guide, particularly if it could be produced quickly and with full support. We would be happy to endorse that as part of the package of measures responding to the issues our Group was established to address. However, the legal advice offered to us suggests that, while food authorities must give due consideration to industry guides, there is no direct requirement imposed on food businesses to comply with them. Nor is any court specifically directed by legislation to give any particular effect to guides in determining any matter before it. We felt that, particularly taken together with more general concerns about enforcement policy and the question of the balance between commercial and public health interests, the lack of legal enforceability of industry guides means that they alone, although worthwhile, would not suffice to tackle the issues of concern to us.

7.19 The problems we see in relation to stricter enforcement of existing regulations lie in the lack of prescription, and hence enforceability, under the 1995 Regulations of some of the measures essential to food safety in the target premises; and the resulting lack of confidence which enforcement authorities have in implementing prohibition or emergency prohibition action under the Food Safety Act 1990. We therefore went on to look at options for legally enforceable measures.

7.20 Two further possible options were identified: additional regulation, or prescription through a licensing system (which would also require regulations). Legal advice was that regulations could be made specifying the various issues which we wished to see addressed, identifying the standards to be achieved and making it an offence for businesses to fall below acceptable standards. As indicated above, Ministers have powers under the Food Safety Act 1990 to regulate by subordinate regulation.

7.21 Ministers are also empowered, under Section 19(1)(b) of the 1990 Act to make regulations introducing the licensing of food businesses. They are expected to do so only when it appears to them necessary or expedient to secure that food complies with food safety requirements or in the interests of public health; or to protect or promote the interests of consumers. The Act authorises the making of regulations to deal with the conditions of licensing and the circumstances in which these can be changed, the cancellation, suspension or revocation of licences and appeals.

7.22 The timetable to implement either regulations or licensing is likely to be similar. The Group do not expect that there would be any fundamental problem with the EU on either approach in that the issues which we identified to be tackled seem to be generally in line with EU policy and unlikely to interfere significantly with intra-Community trade. However, we see the strong balance of advantage in favour of the licensing option in that businesses could be required to meet the necessary conditions prior to the issue of a licence and that provision can be made for immediate remedial measures (ultimately, the removal of a licence) in the event of default.

7.23 We also considered the arguments against licensing - not just on policy/deregulation grounds but also that it can be abused and may not add anything that could not be achieved by 'traditional enforcement'. We accept entirely that there should be a system of checks and balances in any licensing scheme, including appropriate appeal procedures (with premises to remain closed pending the outcome of appeal unless appropriate remedial measures have been taken).

7.24 We also decided, on further reflection, that we did not wish to recommend any system of extended indemnity for food authorities as suggested in our interim report: the prospects of paying compensation if subsequently found to have failed to fulfil the requirements of the Food Safety Act should be one of the moderating factors influencing food authorities in deciding upon what action it is appropriate to take. However we remain of the view that compensation should only be payable if the enforcement authority acted unreasonably.

The Measures to be Regulated

7.25 The 1995 Regulations (Regulation 4 and Schedule 1) set out a number of requirements relating to hazard analysis, critical control points, control and monitoring procedures. There is, however, no requirement for any of the findings to be written down, which calls into question for us the adequacy of the regulations. If there is no documentation, there can be no confidence that the system, or arrangements for it to be verified and reviewed, is in place. No breach of regulations exists, however, solely as a result of lack of documentation.

7.26 The same arguments apply to labelling and record-keeping to facilitate product recall. Again, the evidence the MLC presented to us on that was disappointing. Less than 50% of butchers manufacturing and wholesaling cooked meats (most or all of which would be expected to be covered by the more prescriptive 1994 Regulations) have a product recall system. Only 11% of these have tested that system. The position of those covered by the 1995 Regulations is not known: they are not required to have product recall systems in place (since they sell primarily to the final consumer).

7.27 Evidence on temperature monitoring and controls also suggests practices in butchers' shops are less than ideal, with a significant number failing to keep records of temperature monitoring during cooking, storage and display. Once again, however, the 1995 Regulations are not explicit, requiring only that there should be suitable temperature conditions for the hygienic processing and storage of products.

7.28 The need for physical separation in the production and handling of raw and cooked meat/meat products was something we recommended in our interim report and we have examined further in some detail. Separation should include discrete areas and equipment for the storage, production and display of raw and cooked meats/meat products (and other ready to eat food) and, ideally, separate staff. Premises should be designed so as to avoid, or at least minimise, the need for the crossing of boundaries between the 2 sets of operations. That would involve the use of separate chillers for storage and display, separate production surfaces, equipment and utensils and separate counters, refrigeration and, where possible, staff for the sale and display of goods. Transportation arrangements should also take account of good hygiene and handling practice, including the need for separation of raw meat and cooked/ready to eat foods.

7.29 We also wish to see more explicit requirements in relation to training and qualifications for food handlers, particularly management or supervisory staff and in relation to the structure of premises, equipment and hygiene practices.

Recommendations

7.30 We recognise the need, in relation to all of the issues set out above, to recommend a framework of actions which will improve the protection of public health and minimise the risk of infection with E.coli O157 from cooked meats and meat products. We want also to reflect our support for the general policy approach involving the application and implementation of HACCP. We therefore recommend that HACCP (ie the approach and all 7 principles set out in paragraph 4.3) should be adopted by all food businesses to ensure food safety. While this is being negotiated into EU and domestic legislation, implementation and enforcement of the HACCP principles contained in existing legislation should be accelerated.

7.31 For the reasons set out above, however, we are also clear about the need for measures to bridge the gap between the current position and the achievement of effective implementation of HACCP. We regard the apparent confusion and uncertainty over the application of the 1994 Regulations as unsatisfactory and requiring to be resolved. In any event, we are not persuaded that there is any rationale for differentiating between similar businesses which may be covered by both the 1994 and 1995 Regulations or only by the 1995 Regulations depending solely on the customer supplied (ie whether or not this is the final consumer). Nor do we consider the latter regulations to be sufficiently prescriptive to permit enforcement in some key areas.

7.32 Bearing all of that in mind, we recommend:-

a. that the Government should seek to have HACCP enshrined in the current review and consolidation of the vertical EU Directives;

b. that the Government should seek to have all of the HACCP elements negotiated within the horizontal EU Directive.

c. that the Government should review the application of the Meat Products (Hygiene) Regulations 1994, and the guidance issued subsequently, to clarify the position regarding which premises are intended to be covered by the regulations; and

d. that pending HACCP implementation, selective licensing arrangements for premises not covered by the Meat Products (Hygiene) Regulations 1994 should be introduced by new regulations. The licensing scheme should incorporate a prior approval process, specified requirements in relation to the measures outlined below and the power to remove a licence quickly. An appropriate appeals process would be incorporated, but where a licence has been removed the premises should remain closed until the appeal has been determined. We remain of the view that the premises to be licenced are as set out in our interim report, namely butchers and producers who are handling raw and cooked meats whether at retail, preparation or wholesale. Canneries not approved under vertical legislation should also be included.

7.33 The Group recognises that licensing may become unnecessary when HACCP has been fully implemented in all premises. Meanwhile those premises which voluntarily implement HACCP in full should have few difficulties in meeting the licensing requirements. It is assumed that the licensing system would be operated at a local level through food authorities. Responsibility for oversight and administration of the scheme at the national level would rest with the appropriate central Government departments.

7.34 We recommend that the licensing arrangements should include appropriate requirements for the documentation of hazard analysis, labelling and record-keeping to facilitate product recall and temperature control and monitoring. In relation to training, there should be a requirement for all food handlers to have undertaken at least basic food training and for all supervisory staff (and those who run small, one-person operations) to be trained to at least intermediate level. In addition the licence should cover matters relating to the suitability of premises, equipment and hygiene practices to a level equivalent to that required by the 1994 Regulations.

7.35 The issue of separation is most problematic. In the interests of food safety, and in light of the evidence emerging about outbreaks which occurred while our work was underway, we do not wish to move significantly from our view of the need for wholly separate equipment and staff. We recognise, however, the impact which the requirement for separate staff in particular could have on small, local butchers (and hence rural communities in particular) and also the need to acknowledge the overarching policy approach in relation to HACCP implementation. Bearing all of that in mind, we recommend in relation to the physical separation requirements of licensing:-

a. that there should be separation, in storage, production, sale and display, between raw meat and unwrapped cooked meat/meat products and other ready to eat foods. This should include the use of separate refrigerators and production equipment, utensils and wherever possible, staff;

b. that where the use of separate staff cannot be achieved, alternative standards (such as the completion and implementation by the operator of a HACCP or the provision and use of additional facilities eg for hand washing in the serving area) might be regarded as sufficient to permit the award of a licence. Central Government departments will wish to give further thought as to precisely how this arrangement might operate; and

c. that where neither a. nor b. above can be achieved, the premises concerned should not be permitted to sell both raw and unwrapped cooked meat/cooked meat products (although they may be permitted to sell pre-wrapped cooked/ready to eat meat products prepared elsewhere and brought in for that purpose).

7.36 Because of our concern about the virulence of E.coli O157 and the low infective dose, we also recommended in our interim report that the ACMSF should review the guidance on cross-contamination in its 1995 Report. The Secretary of State also referred to the ACMSF our priority recommendations on research (see Chapter 11).

7.37 Following preliminary discussions with Group members, the ACMSF set up an ad hoc Working Group to consider the issues in more detail. We met with the Working Group and provided it with information on the Central Scotland outbreak and a copy of the MLC report. A copy of the Working Group's report, which has been endorsed by ACMSF, is attached at Annex VI. In summary, the Working Group agrees with our views on the importance of HACCP and that its implementation should be accelerated for certain premises. (Indeed, it suggests more premises should be covered by accelerated implementation.) It also agrees that implementation of existing hazard analysis requirements in legislation has been too slow and should be enforced; that hazard analysis plans should be documented; and highlights the importance of training. It suggests, however, that the prevention of contamination is best assured by good hygiene and manufacturing practices as determined by hazard analysis and control at critical points of the operation and that compulsory separation of raw and cooked meat/meat products could lull the management and staff of the target premises into a false sense of security. It accepts that physical separation of raw and cooked meats will be necessary in some (but not all) businesses. However it has concluded that there is no reason to depart from the approach and guidance on cross-contamination set out in the 1995 ACMSF report.

7.38 We welcome the broad level of agreement that clearly exists between our Group and the ACMSF and the supportive nature of the Working Group's report. We have considered very carefully the points that have been made about the issue of separation. We cannot share the ACMSF's confidence in existing food safety legislation, however rigorously enforced, as an adequate means of protection for the public against E.coli O157. For that reason, and for the reasons set out earlier in this Chapter, we therefore remain persuaded of the need for the physical separation measures we have specified and of the need for licensing to bridge the gap until HACCP is universally implemented.

7.39 We are also happy to endorse the introduction of industry guides, referred to in paragraphs 7.17 and 7.18, to reinforce the proposed licensing arrangements and promote good practice.

Costs of Compliance

7.40 The costs of introducing licensing arrangements have not been assessed. It is acknowledged that they could be considerable although food authority costs could be offset to some extent by licensing fees. The costs of licensing, however, need to be considered alongside the significant costs of patient care and other costs associated with food poisoning outbreaks.

7.41 The main costs of compliance by businesses would be likely to relate to the need for physical separation. The MLC estimate the capital costs of that (for the necessary equipment and associated infrastructure costs), for Scottish butchers, to amount to around ü21 million. That is based on estimates of costs for individual businesses ranging from around ü6,000 to ü20,000 for equipment and ü3,500 to ü16,500 for structural changes. For Great Britain, the MLC estimates total capital costs for butchers of around ü187million.

7.42 We noted in our discussions on this issue that a number of butchers have already made progress towards achieving physical separation or have indicated that they could accommodate it without the need for substantial additional equipment or structural change. It is also the case that an unknown, but quite possibly substantial, proportion of the estimated capital expenditure would be required anyway by butchers in order to meet fully the current regulatory requirements. Simply grossing up the estimated average costs of compliance is likely, therefore, substantially to overestimate the level of capital expenditure required to introduce selective licencing as such..

7.43 The MLC also estimated the likely additional revenue costs of fully implementing the Group's recommendations for the use of separate staff. Based on an average employment cost of ü15,000 per annum, additional butcher revenue costs of ü20 million per annum (in Scotland) and ü160 million (in Great Britain) are estimated. (These costing do not of course take account of the modification of our recommendations referred to in paragraph 7.35.)

The Application of Licensing Arrangements to Other Premises

7.44 A number of representations were made to us that selective licensing arrangements, if introduced, should not be restricted to premises producing raw and cooked meat/meat products, but should be extended to other potentially high risk operations/premises - for example carry-out premises, bakers and other catering establishments. We acknowledge the force of the arguments that the risks to public health inherent in some of these premises/operations may be no less than in the target premises. We see no reason in principle why licensing arrangements could not be extended to cover other areas, based on HACCP-style assessment of the hazards and critical control points which exist. The Group's remit however, did not permit us to extend our research and recommendations beyond the areas relevant to the Central Scotland and Tayside food poisoning outbreaks.