Food Safety (General Food Hygiene) (Butchers' Shops) Amendment Regulations 2000
Sunday 15 October 2000
Regulatory Impact Assessment
Note: The Regulations covered by this Regulatory Impact Assessment apply to England only
Title
The Food Safety (General Food Hygiene) (Butchers' Shops) Amendment Regulations 2000.
Purpose and Intended Effect of the Measure
Issue
An outbreak of E.coli O157 food poisoning occurred in Central Scotland in November 1996. The subsequent Fatal Accident Inquiry, which published its findings in August 1998, concluded that the outbreak led directly to the deaths of 17 people. Around a further 500 people are known to have been made ill as a result of the outbreak
The Government established an Expert Group under the Chairmanship of Professor Hugh Pennington to examine the causes of the outbreak. The Pennington Group published its full report in April 1997 and made 32 recommendations for action, all of which were accepted by Government on 11 June 1997.
The Pennington Group identified cross-contamination from raw meat to ready-to-eat foods through poor handling and hygiene practices in a butcher's shop as the main cause of the Central Scotland E.coli O157 outbreak. The high virulence and low infective dose of E.coli O157, together with other evidence provided to the Pennington inquiry, prompted the Pennington Group to recommend stricter hygiene controls for butchers handling raw meat alongside cooked meats and other ready-to-eat foods. The Government has accepted all of the recommendations made in the Pennington Report, including the introduction of a statutory annual licensing scheme enforced by local food authorities.
Objective
The Regulations will introduce statutory annual licensing of retail butchers' shops in England handling and selling unwrapped raw meat and ready-to-eat food from the same premises. The intended effect of the measure is to improve the standards of food hygiene management and control in these premises in order to enhance public protection.
Risk Assessment
Verocytotoxin producing E.coli (VTEC) infections are associated with a range of illness in humans. E.coli O157, the strain of the organism responsible for the Central Scotland outbreak of 1996, is highly virulent and the predominant cause of human infection with VTEC. Reports of E.coli O157 infections across the UK have increased steadily in recent years. Evidence from outbreak investigations suggests that the infective dose is low and that illness may occur after the ingestion of less than 100 organisms. E.coli O157 is known to cause a range of symptoms from mild to bloody diarrhoea and, in a small number of cases, heamolytic uraemic syndrome (HUS) and kidney failure. The effects of E.coli O157 poisoning are potentially very serious for vulnerable groups, such as young children and old people, and can be fatal.
Humans can become infected with E.coli O157 in a number of ways. The E.coli O157 organism is found mainly in the intestines of farm animals, especially cattle, and infection can occur through direct contact with animals and faeces carrying the organism and through person-to-person contact as a result of poor personal hygiene practices. Human infection with the organism can also occur through consumption of contaminated food or water. A variety of foodstuffs have been implicated in E.coli O157 outbreaks, including undercooked minced meat products such as beef burgers, milk, cheese and apple juice. Raw meat can become contaminated with E.coli O157 by coming into contact with faecal matter from farm animals at slaughter. The consumption of ready-to-eat foods, such as cooked meats, contaminated with E.coli O157 by cross-contamination from raw meat carrying the organism is therefore another likely cause of human infection and illness.
Options
Three options have been considered:
Option 1 - No action;
Option 2 - license all butchers' shops (including butchers handling unwrapped raw meat only);
Option 3 - license only butchers handling and selling unwrapped raw meat together with ready-to-eat foods;
Option 1
This would involve no action. Pursuing this option would contradict the public commitment given by Government soon after it came into office in 1997 to licence butchers? shops as recommended by the Pennington Group. As such it is likely that taking no action would attract criticism from those affected by the Central Scotland E.coli O157 outbreak, particularly as it would contrast sharply with action in Scotland where there is a strong commitment to licensing.
Option 2
Option 2 envisages a licensing scheme covering all retail butchers' shops, including butchers handling raw meat only. Shops would need to satisfy a number of conditions before qualifying for a licence, including:
- compliance with existing relevant food hygiene and temperature control legislation;
- the operation of a documented Hazard Analysis Critical Control Point (HACCP) food safety management system. This builds on the requirement in existing legislation for hazard analysis under the Food Safety (General Food Hygiene) Regulations 1995, which requires food hazards to be identified and controlled, and procedures reviewed;
- enhanced hygiene training for food handlers and supervisory staff over and above the provisions of the 1995 general hygiene regulations.
Option 2 is consistent with the recommendation of the Pennington Group which supported a HACCP approach to control in butchers, although they saw this as a longer term objective. However, it goes further than the Pennington recommendation by including raw meat only butchers in the licensing approach.
It is possible to move directly to a licensing scheme in England based on HACCP due to the help and training provided to retail butchers through the centrally funded Accelerated HACCP Initiative managed by the Meat and Livestock Commission (see Appendix 2). HACCP has the potential to reduce considerably the cost of compliance when compared with detailed prescriptive requirements without compromising on food safety. The extent of this reduction would depend on the nature and scale of operations in individual businesses, the extent to which businesses are complying with the requirements of existing hygiene legislation and the extra work required to implement HACCP systems in their premises in order to fulfil the licensing condition. (See paragraphs 24 and 25 below on compliance costs and the Small Firms Litmus Test attached at Appendix 1).
Option 3
13. This option entails a licensing scheme similar to that outlined under option 2, the main difference being that under this option licensing would be focused on butchers' shops handling and selling unwrapped raw meat and ready-to-eat foods from the same premises. Butchers handling and selling only raw meat would not need a licence under this option.
Option 3 is more consistent than option 2 with the recommendation of the Pennington Group which sought the introduction of measures in butchers' shops to control the risk of cross-contamination between raw meat and cooked/ready-to-eat food. This approach also reflects many comments received in GB consultation in 1998, mainly from enforcers, questioning the justification for licensing butchers' shops dealing in raw meat only given the reduced cross-contamination risks, and consequent lower public health risks, in these premises.
Issues of Equity and Fairness
The Central Scotland outbreak of November 1996, linked to a local butcher, caused the deaths of 17 people and 500 cases of illness. It remains the UK's worst food poisoning outbreak. The Government believes, therefore, that the introduction of a statutory licensing scheme for retail butchers conditional on the introduction of enhanced food hygiene measures, is justified in the interests of public health. The Regulations provide for a lead-in period lasting 6 months to allow butchers prepare for the licensing requirements. In addition, butchers will benefit from the centrally funded HACCP implementation initiative described in Appendix 2.
The Government has received strong representation, mainly from enforcement interests, arguing for the extension of licensing to other sectors of the food industry which pose similar risks to those in butchers' shops handling unwrapped raw meat and ready-to-eat food. Having considered these views carefully, Ministers have decided that these licensing proposals should concentrate on retail butchers' shops handling unwrapped raw meat and ready-to-eat foods in line with the recommendation in the Pennington Report. However, the Government is prepared to consider a wider licensing approach where there are justified public health concerns.
Benefits
This section identifies the benefits of each option and seeks to quantify and value those benefits.
Option 1 - No action
This option would require no change in retail butchers' shops. It would have no financial costs but would not address the specific public health risks highlighted in the Pennington Report. Doing nothing would not ensure the improved hygiene controls in butchers' shops which Government considers necessary for better consumer protection from food sold in these premises. This option would also fail to recognise the broad support received for licensing in public consultation and the Government?s acceptance of the recommendation for licensing by the Pennington Group.
Option 2 - License all butcher shops
It is not possible to quantify or value the benefits of this option in financial terms or estimate the number of deaths or cases of illness that licensing might prevent. The benefits are more likely to be realised in terms of better hygiene controls and practices in butchers' shops and a better awareness among butchery staff of the dangers posed by E.coli O157 and how these can be controlled. The hygiene measures introduced as a result of licensing will also improve public protection from other food poisoning bacteria, such as salmonella and campylobacter. We believe licensing would also help restore public confidence in the butchery sector, with a knock on benefit for the meat industry as a whole. However, licensing butchers' shops that handle and sell raw meat only can be argued as unjustifiable on the basis that the risk of contaminating ready-to-eat food is absent.
Option 3 - License only butchers handling unwrapped raw meat together with ready-to-eat foods
Option 3 reflects a more risk-based approach to licensing given the significantly higher risk of cross-contamination from raw meat to cooked/ready-to-eat food in butchers' shops dealing in those products. By comparison, such cross-contamination risks in shops dealing only in raw meat are unlikely to arise. Despite its narrower scope, this option can be expected to deliver substantially the same public health protection and other benefits as the approach outlined under option 2.
Compliance Costs for Business, Charities and Voluntary Organisations
Business sectors affected
The licensing proposals would impact on the retail butchery sector in England. This includes high street retail butchers' shops, butchery service outlets in multiple retail businesses such as supermarkets, mobile butcher shops and stalls, and some on-farm shops.
We estimate that there are approximately 9,000 butchers' shops in England. This figure is comprised of some 6,700 shops dealing in raw meat and cooked meats/ready-to-eat foods, with the remaining 2,300 or so dealing in raw meat only. In addition, we estimate there are approximately 1,700 multiple retail outlets in England with butchery service counters. This may underestimate the number of multiple retail outlets, however, we received no information during consultation to confirm this.
Compliance costs for a typical business
Option 1 imposes no costs on business. The following costs are for options 2 and 3. The main compliance costs are associated with the implementation of HACCP food safety management procedures, the provision of staff training and the payment of a licence fee of ¿100 on receipt of a licence.
Cost of implementing HACCP procedures
Based on discussions with individual businesses (the litmus test), trade associations and the Meat and Livestock Commission, the non-recurring costs of implementing HACCP procedures in a typical business are outlined below. These estimates are dependent on the nature of the business, i.e. the types of products handled the extent to which they are complying with existing hygiene legislation and the extra work required to implement effective HACCP procedures.
- between £0 and £500 in raw meat only butchers;
- between £1,000 and £5,000 in premises manufacturing and selling a range of cooked meats alongside raw meat; and
- between £0 and £1,500 in premises buying in a range of cooked meats for resale together with raw meat.
However, it has become evident from the operation of the accelerated HACCP scheme that these costs mainly relate to the operating and structural changes needed to achieve compliance with the existing 1995 hygiene Regulations rather than the implementation of HACCP controls under a licensing scheme. Taking into account the Government funded voluntary MLC programme providing HACCP support to over 7,000 butchers, the licensing Regulations will not introduce significant new costs for businesses other than those associated with training and the licence application fee - see below.
Cost of training
The original Cost Compliance Assessment published as part of the 1998 GB consultation exercise estimated national training costs to the industry on a GB basis of some £6.5 million. This figure was calculated on the basis of licensing 13,500 premises. Given the reduced number of premises covered in these England proposals (approximately 9,000) and the free HACCP training made available to approximately 7,500 managers through the centrally funded MLC Accelerated HACCP Initiative, the compliance cost of training under option 2 for the butchery sector in England could be expected to be nearer £3.5 million. This works out at an annual average cost per premises of around £390. On this basis the total training costs for option 3 (6,700 shops) would be approximately £2.6 million.
Cost of getting a licence
Licensing all 9,000 premises (at a cost of £100 per premises) under option 2 would entail a total annual cost of £900,000 to the butchery sector. If raw meat only butchers were excluded the annual cost under option 3 would fall to £670,000. If all of the estimated 1,700 multiple premises with butchery outlets fell within the scope of the licensing Regulations, this would add £170,000 to the annual cost of both options derived from licence fees.
Total Compliance Costs
Total recurring costs for option 2 are estimated to be around £3.5 million for training and ¿900,000 from licence fees, giving a total recurring cost of £4.4 million (or just over £4.5 million if all 1,700 multiple premises are licensed).
Total recurring costs for option 3 are estimated to be around £2.6 million for training and ¿670,000 from licence fees, giving a total recurring cost of £3.3 million (or around £3.4 million if all 1,700 multiple premises are licensed).
Consultation with Small Business: 'The Litmus Test'
In addition to the main GB consultation exercise, which included organisations and trade bodies for small businesses, the licensing proposals were discussed with three businesses. A small firms litmus test is attached at Appendix 1.
Other Costs
We estimate that there would be additional costs to local authorities involved in assessing and issuing licences. The proposed ¿100 licence fee, to be retained by local authorities, will offset these additional costs.
Results of Consultation
The Government consulted publicly on its licensing proposals between 23 February and 22 May 1998. The consultation documents proposed the introduction of an annual licensing scheme for retail butchers? shops conditional on the introduction of enhanced hygiene measures to reduce cross-contamination risks. It was proposed that licensing should apply to butchers? shops dealing in raw meat only and to those dealing in raw meat and cooked/ready-to-eat foods, i.e. in effect the option 2 approach.
Approximately 1,000 organisations were consulted including other government departments, local authority environmental health departments and professional bodies, food companies, trade associations, research and consumer interests. A copy of the proposals was also placed on the Department of Health internet web site. A total of 176 responses were received from organisations and individuals in England. The majority of responses (69%) were from enforcement authorities, 13% came from trade associations and businesses while the remainder (18%) were received from other sources, mainly individuals and consultants working in the field.
While issues were raised on specific aspects of the proposals, there was broad support, by a ratio of 4 to 1, for the introduction of a licensing scheme for butchers. Most support came from food law enforcement authorities, and the Consumers' Association was strongly in favour of licensing butchers as a means of improving consumer protection. Most resistance came from trade associations and the industry. A HACCP based system was preferred by a majority of 2 to 1 over one based on prescriptive physical separation requirements to prevent cross-contamination. The proposal for a ¿100 licence fee appeared to be non-contentious as it attracted replies from less than 1 per cent of those who responded to the consultation proposals.
Approximately 30 per cent of respondents, mainly local enforcement authorities, questioned whether butchers who deal only in raw meat should be covered by the regulations on risk grounds. Ministers were convinced by the arguments put forward that the scope of the licensing Regulations should be drawn more tightly to focus on those butchers' shops that presented the highest risk to public health, namely shops handling and selling unwrapped raw meat and ready-to-eat food. This is the approach outlined under option 3 above. Ministers decided to proceed with EU notification on the basis of option 3 on 5 August 1999. A copy of the revised draft Regulations were made public on 6 August and circulated for information to interested organisations. A copy of the revised Regulations was also placed on the Department of Health web site at the same time. The revised Regulations successfully completed the EU notification process on 12 November 1999.
The licensing proposals notified to the European Commission reflect a number of other revisions to the original proposals arising from the GB consultation. The definition of "meat" has been changed to exclude meat products and meat preparations (such as cured bacon and sausages) so removing from the scope of the licensing scheme delicatessens, corner shops and similar outlets selling these products together with ready-to-eat foods, but no fresh meat.
Meat has been redefined as fresh meat, to include poultry, rabbit, and wild and farmed game as these raw meats are similar to red meat where cross-contamination risks are concerned.
Other amendments which have been made to the Regulations clarify
- how the licensing arrangements will apply in mixed business premises, such as supermarkets, with a butchery service outlet;
- the requirements on licensed shops to keep records; and
- the training requirements for staff.
Summary and Recommendations
| Option 2 Expected Costs | Option 3 Expected Costs | Option 2 Expected Benefits | Option 3 Expected Benefits | |
|---|---|---|---|---|
| Business | Recurring costs of around £4.5 million per annum; No significant one-off costs envisaged | Recurring costs of around £3.3 million per annum; No significant one-off costs envisaged | Butchery sector can expect to benefit commercially as a result of renewed consumer confidence. Knock on benefits for the meat industry generally. | Same as option 2 |
| Charities | None | None | None | None |
| Citizens | Difficult to determine - likely to be negligible. | Same as option 2 | Better consumer protection resulting from improved hygiene standards and controls in butchers' shops | Same as option 2 |
| Government | (i) Central Govt. - £4.5M for centrally co-ordinated initiative to help butchers implement HACCP systems. (ii) Local Government - extra costs offset by licence fee. | Same as option 2 | Consistent with Government's acceptance of all 32 Pennington Group recommendations | Same as option 2 (ii) enables local food authorities focus resources on higher risk butchers. |
Option 1 is rejected on the grounds that it does not improve public protection from food sold in butchers' shops or implement the specific recommendation on licensing in the Pennington Report, which has been accepted by Government. The choice is therefore between options 2 and 3. Both options require exactly the same enhanced hygiene conditions to be satisfied as a pre-condition of licensing. The only difference between the two options is their scope with regard to the types of businesses covered.
40. Focusing the Regulations on butchers' shops dealing in unwrapped raw meat and ready-to-eat foods, as proposed in option 3, represents a more risk-based approach as the consequences of cross contamination are the most serious in public health terms. This approach is also consistent with the findings of the Pennington Group whose concerns were concentrated on these types of premises. It also reflects the outcome of the GB consultation. Option 3 would also enable food authorities to target their resources more closely on these higher risk premises. Option 3 is therefore recommended.
Enforcement, Sanctions, Monitoring and Review
Local food authorities will be responsible for enforcing these regulations. Food authorities have been given the power to grant licences, refuse applications which do not satisfy the licensing requirements, and to suspend or revoke licences where the licensing conditions are breached. Licence holders have the right to appeal any such decisions to a magistrate?s court under section 37(5) of the Food Safety Act 1990. Premises may remain open until appeals are determined unless there is an imminent risk to public health, in which case the existing emergency powers for immediate closure contained in the Food Safety Act 1990 would apply.
Under paragraph 2 of Schedule 1A of the amendment Regulations, it would be a criminal offence to operate a butcher's shop as defined without a current licence.
The Joint Food Safety and Standards Group intends to issue Guidance Notes to accompany the amendment Regulations following consultation with interested parties.
The amendment Regulations will be subject to monitoring in liaison with the Local Authority Co-ordinating Body on Food and Trading Standards (LACOTS) to assess their implementation and effect. A review of the implementation of the licensing scheme will be carried out two years from the date the licensing conditions take full effect.
Declaration:
I have read the Regulatory Impact Assessment and I am satisfied that the balance between cost and benefit is the right one in the circumstances.
Signed by the responsible Minister - GISELA STUART
Date: 26 March 2000
CONTACT POINT
Name: Kieran Power
Address: Food Standards Agency
Microbiological Safety of Food & Nutrition Divisions
Room 501A, Skipton House
80 London Road
London SE1 6LH
Telephone: 020 7972 5035
MSF&N
APPENDIX 1
SMALL FIRMS LITMUS TEST
With the assistance of the National Federation of Meat and Food Traders (NFMFT), two companies representing the industry were identified for interview. NFMFT membership is by and large made up of small businesses and sole traders. Derby City Council assisted in identifying a third business.
Business I - the first company interviewed sold raw meats and a wide selection of cooked meats (many prepared on the premises) and other ready to eat foods e.g. cheese. The firm employs 28 full time staff and whilst unwilling to discuss turnover, is likely to have an estimated turnover of up to £1 million per annum. The proprietor already had a HACCP system in place and all staff were trained in Food Hygiene. He did not envisage the proposed regulations would involve his firm in significant additional costs. He supported both the principle of licensing and HACCP being made a requirement. He expressed the view that a £100 annual charge was reasonable.
The proprietor had no reliable figure on the costs of operating HACCP, based on increased monitoring. He estimated that it might result in six hours a week at £10 per hour (£3k per annum). A large part of this control activity, however, would be required by the existing legal requirement.
Business II - the second firm interviewed was a family run business selling raw and cooked meats (some prepared on the premises) with a limited range of other ready to eat food. The business is run by two brothers who employed six staff at the time of the interview. On the basis of staff numbers, NFMFT estimated turnover is likely to be approximately ¿400,000 per annum. The proprietors had received Food Hygiene training but none of the staff had any formal hygiene training. The premises introduced HACCP controls following the introduction of the Food Safety (General Food Hygiene) Regulations 1995. The proprietor interviewed did not consider the HACCP system involved significant costs. Whilst running the system did involve an ongoing cost, he did not consider it to be onerous, and had not costed it. The company agreed that licensing butcher would be a good move and felt a ¿100 licensing fee (as proposed in the consultation) was reasonable and should not affect butchers adversely.
Business III - the third company was run by a husband and wife with no employees. The company sold raw meats and a limited range of cooked meats and other ready to eat foods. Some cooked meats, e.g. ham and pies, were made on the premises. The company did not have HACCP in place but had worked with the local Council to introduce non-documented procedures to control food hazards. The proprietor did not feel that documenting the current procedures would involve significant additional cost or expertise and was in the process of doing this anyway. He supported moves to introduce HACCP as it enabled him to introduce the necessary controls to suit the needs of the business. For example, to control contamination cooked meat preparation is carried out on set days during the week when no raw food preparation takes place in the same room. He considered licensing of butchers to be reasonable and offered no objection to a charge in the region of ¿100.
Business I, II and III: HACCP Implementation Costs
None of the proprietors were in a position to give reliable estimates of the implementation costs. However, we discussed the nature and scale of the operations in these businesses with the MLC prior to the GB consultation exercise in the first half of 1998. The indications at that time were that implementation costs for each business would fall within the range of between ¿1,000-¿5,000, and these estimates were set out in paragraph 7 of the Government?s Cost Compliance Assessment published on 23 February 1998. More recent evidence obtained from the operation of the centrally funded accelerated HACCP initiative managed by the MLC indicate that these costs would include a significant element related to effective compliance with the 1995 general food hygiene regulations. Consequently, we now believe that the licensing Regulations will not impose significant extra costs on business other than those associated with staff training and the licence fee (see paragraphs 21-29 of the Regulatory Impact Assessment).
Summary
In summary, the traders interviewed supported proposals to introduce HACCP enhanced food hygiene training and licensing, and felt that these measures would have limited commercial effect on their businesses. All butchers questioned felt the annual licence fee of £100 was reasonable.
Updated by:
Microbiological Safety of Food and Nutrition Divisions
March 2000
APPENDIX 2
HAZARD ANALYSIS CRITICAL CONTROL POINT (HACCP)
HACCP is internationally recognised as the most effective way to manage food safety in food businesses and protect public health. It provides a structured, methodical approach to ensuring final food safety through managing and controlling hazards inherent in the food handling and production process. The advocates of HACCP include the Codex Alimentarius Commission of the World Health Organisation, the European Commission and the UK Government's independent Advisory Committee on the Microbiological Safety of Food (ACMSF). The promotion of HACCP implementation across the food industry is also a key element of the UK Government?s strategy to improve food safety and consumer protection.
The licensing Regulations will require butchers to operate HACCP procedures in their shops based on the following principles:
- analysis of the potential food hazards in food business operations;
- identification of the points in those operations where food hazards may occur;
- deciding which of the points identified are critical to ensuring food safety ("critical points"), i.e. the steps at which control can be applied and are essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level;
- identification and implementation of effective control and monitoring procedures (including critical limits), at those critical points. Critical limits are criteria or values which separate acceptability from unacceptability. Achieving a minimum cooking temperature necessary to kill all harmful bacteria or maintaining a fridge temperature of 8 degrees C or less for food which needs to kept under chill conditions for food safety reasons are examples of critical limits;
- verification to confirm that the HACCP procedures are working effectively;
- review of the analysis of food hazards, the critical points and the control and monitoring procedures periodically, and whenever the food business' operations change, and
- documentation of all procedures appropriate to the effective application of these principles, including documentation relating to the staff training undertaken to comply with the licensing Regulations.
ACCELERATED HACCP FOR BUTCHERS' SHOPS IN ENGLAND
The Department of Health has made ¿4.5 million available to fund a major initiative to accelerate the introduction of HACCP into independent retail butchers? shops in England. The aim of the initiative is to help improve hygiene controls and standards in over 7,000 butchers? shops and protect consumer health before licensing is introduced in spring 2000. The initiative is being centrally managed and co-ordinated by the Meat and Livestock Commission (MLC) on behalf of the Government. The initiative implements another important recommendation of the Pennington Group which has fully endorsed HACCP as the most effective way of minimising risk and protecting the consumer.
Key Features of the Initiative
The key features of the initiative are:
- the development of a generic HACCP system for use in retail butchers' shops and associated training materials; these have been approved by the Royal Institute of Public Health and Hygiene (RIPHH), the custodian of the HACCP standard in the UK, and endorsed by the project Steering Group (see below);
- the provision of free advice and formal hygiene training over two days for one member of staff per butcher premises, which includes instruction in how to devise and manage an effective HACCP system;
- this is followed by on-site advice and support to retail butchers to reinforce the training and ensure that effective HACCP arrangements are in place;
- the introduction of a home study option from November 1999;
- project oversight by a Steering Group involving Government, professional, enforcement, industry and consumer representatives.
Progress to date
Over 8,800 butchers, out of a total of approximately 10,500 shops on the MLC's English database, have registered for the initiative since it was launched in autumn 1998. Around 7,300 butchers had been trained by the middle of March 2000 with over 6,600 of these operating accredited HACCP systems in their shops. These figures do not include any licensable premises that may be making their own arrangements to put HACCP systems in place before the licensing Regulations come into force.