The Food Safety (General Food Hygiene) (Butchers' Shops) (Amendment) (Wales) Regulations 2000

Friday 12 October 2001

Regulatory Impact Assessment

Title
The Food Safety (General Food Hygiene) (Butchers' Shops) (Amendment) (Wales) 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 UK 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 the UK 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 UK 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 Wales 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 the UK 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 Wales based on HACCP due to the help and training provided to retail butchers through the centrally funded Accelerated HACCP Initiative (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
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 UK 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 to allow butchers to prepare for the licensing requirements. In addition, butchers have benefited from the centrally funded HACCP implementation initiative described in Appendix 2.

The UK 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, the Assembly has 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. The Food Standards Agency will advise the Assembly on any future licensing which may be justified on public health grounds.

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 the Assembly 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 UK 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 Wales. 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 1,100 butchers' shops in Wales. This figure is comprised of some 800 shops dealing in raw meat and cooked meats/ready-to-eat foods, with the remaining 300 or so dealing in raw meat only. In addition, we estimate there are approximately 200 multiple retail outlets in Wales 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
The estimated 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 centrally funded voluntary programme providing HACCP support to an estimated 1,000 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 Wales proposals (approximately 1,100) and the free HACCP training made available to approximately 1,000 managers through the centrally funded Accelerated HACCP Initiative, the compliance cost of training under option 2 for the butchery sector in Wales could be expected to be nearer £400,000. This works out at an annual average cost per premises of around £365. On this basis the total training costs for option 3 (800 shops) would be approximately £290,000. We would expect overall training costs for the butchery sector to fall after the first year, as these will be one-off costs to the majority of butchers' shops.

Cost of getting a licence
Licensing all 1,100 premises (at a cost of £100 per premises) under option 2 would entail a total annual cost of £110,000 to the butchery sector. If raw meat only butchers were excluded the annual cost under option 3 would fall to £80,000. If all of the estimated 200 multiple premises with butchery outlets fell within the scope of the licensing Regulations, this would add £20,000 to the annual cost of both options derived from licence fees.

Total Compliance Costs
Total costs for option 2 are estimated to be around £400,000 for training and £110,000 from licence fees, giving a total annual cost of £510,00 (or around £530,000 if all 200 multiple premises are licensed).

Total costs for option 3 are estimated to be around £290,000 for training and £80,000 from licence fees, giving a total annual cost of £370,000 (or around £390,000 if all 200 multiple premises are licensed).

Under both Option 2 and Option 3, total costs would decrease following the first year, since training costs would be one-off costs to the majority of butchers' shops.

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 UK 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.

Over 1,000 organisations were consulted UK-wide. In Wales, the exercise included local authority environmental health depart-ments and professional bodies, food companies, trade associations, research and con-sumer interests.

On balance, broad support was shown for the introduction of a licensing scheme for butchers, and respondents were generally content with the HACCP-based approach, rather than specific physical separation requirements to prevent cross-contamination. There was also some concern shown over effect of the £100 licence fee on small businesses.

A number of respondents queried various aspects of the definition of a butcher's shop, and some expressed the view that butchers dealing in raw meat only should not be covered. The general balance of these views were much the same across England and Wales. In light of the consultation, English Ministers decided that the scope of the licensing Regulations in England 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. The National Assembly for Wales agrees that this approach should be reflected in the Regulations in Wales.

The licensing proposals 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.

Following these revisions to the original proposals, interested enforcement, industry and consumer organisations in Wales were given a further opportunity to comment on the purpose and intended effect of the measure, including the financial implications associated with the introduction of the scheme, on 19 April. A total of 11 responses were received. The majority of these responses (7) were from enforcement authorities, while the remainder were received from trade associations and businesses.

Again, general broad support was shown towards the introduction of the licensing scheme. A summary of the responses is attached at Appendix 3.

Summary and Recommendations

	Option 2 Expected Costs	Option 3 Expected Costs	Option 2 Expected Benefits	Option 3 Expected Benefits
Business	Recurring costs of around £530,000 per annum; No significant one-off costs envisaged	Recurring costs of around £390,000 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 minimal.	Same as option 2	Better consumer protection resulting from improved hygiene standards and controls in butchers' shops	Same as option 2
Government	(i) National Assembly ?£1.2M for centrally co-ordinated initiative to help butchers implement HACCP systems. (ii) Local Government ? extra costs covered by licence fee.	Same as option 2	Consistent with UK Government?s acceptance of all 32 Pennington Group recommendations	Same as option 2 (ii) enables local food authorities to 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 the UK 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.

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 Food Standards Agency intends to issue Guidance Notes to accompany the amendment Regulations.

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.

Contact point
Keith Blake
Food Standards Agency Wales
1st Floor, Southgate House
Wood Street
Cardiff CF10 1EW
Telephone: 029 2067 8902 Fax: 029 2067 8919
Email: keith.blake@foodstandards.gsi.gov.uk

APPENDIX 1

SMALL FIRMS LITMUS TEST

With the assistance of the National Federation of Meat and Food Traders (NFMFT), a number of small businesses were invited to participate in the exercise. Three companies representing the industry were identified for interview.

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 involving 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, prior to the GB consultation exercise in the first half of 1998, 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 UK Government's Cost Compliance Assessment published on 23 February 1998. More recent evidence obtained from the operation of the centrally funded accelerated HACCP initiative indicates 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.

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 WALES

The National Assembly for Wales made £1.2 million available to fund a major initiative to accelerate the introduction of HACCP into independent retail butchers' shops in Wales. The aim of the initiative was to help improve hygiene controls and standards in over 1,100 butchers' shops and protect consumer health before licensing is introduced in autumn 2000.

Key Features of the Initiative

The key features of the initiative were:

• the development of a generic HACCP system for use in retail butchers' shops and associated training materials; these were approved by the Royal Institute of Public Health and Hygiene (RIPHH);
• the provision of free advice and formal hygiene training over two days for one member of staff per butcher premises, which included instruction in how to devise and manage an effective HACCP system; and
• on-site advice and support to retail butchers to reinforce the training and ensure that effective HACCP arrangements were put in place.

Progress to date
Nearly all of the 1,100 butchers' shops in Wales took advantage of the initiative since it was launched in autumn 1998. Around 1,000 butchers had been trained by the middle of March 2000 with the majority of these operating accredited HACCP systems in their shops. These figures do not include any licensable premises that were making their own arrangements to put HACCP systems in place before the licensing Regulations come into force.

APPENDIX 3

Summary of the responses to consultation exercise

CONCERNS

A need for consistent enforcement throughout Wales, and with other parts of UK.

Compliance with General Food Hygiene Regulations and General Food Temperature Control Regulations.

Regulation 5(1)(c) ? the term "working in the shop". If a business has a number of shops, can an employee move in from one to another to satisfy this requirement.

A supplement to the Industry Retail Guide is currently in draft form in England. It would be sensible to adopt this as a guide for compliance in Wales.

Need to have a more precise definition of "ready-to-eat foods". Small butchers? shops selling such items as cans, bottles or packs, whilst not selling cooked "at risk" foods should not need to be licensed.

A large part of the total compliance costs will have already been met by the HACCP implementation scheme, which The Welsh Office funded. It can be argued that any additional training costs to business might have been incurred in otherwise complying with the Food Safety (General Food Hygiene) Regulations.

The fewer the businesses which have to fulfil the licensing requirements, the more are likely to survive.

Costs of staff training, together with expenses of new cabinets and storage facilities, would be substantial.

The actual extent of staff training requirements is not specified.

The Home Authority Principle should apply to the approval of HACCP procedures, where a trader operates two or more businesses situated in different local authorities.

Exclusion of such products as sausages and bacon from the definition of raw meat, removes from the scope of the Regulations, such premises as delicatessens and corner shops. Would consider it more reasonable to exclude such premises if such foods were sold ready-wrapped by the producer.

Premises that sell mainly fruit and vegetables but also sells ?game? to be included in the scheme. Would such premises still need a licence to sell ?game? in addition to the butchers licence.

Regulation 5(6) ? the term "equipment". Would this include sinks and wash-hand basins, or does it cover only items such as cutting utensils.

Premises selling unwrapped raw mince meat, sausages or burgers alongside ready-to-eat foods will not require licensing. Guidance needs to accompany the Regulations to clarify this.

Confusion between requirements of food authority to give determination notice to the "applicant", and the requirement that the "proprietor" be given notice of a suspension or revocation of the licence.

The Regulations will not introduce any significant new costs to butchers? shops who participated in HACCP scheme, other than those costs associated with training and the licence fee.

In favour of having the same laws in force across the four parts of the UK.

CONCERNS

Unclear about training provisions, as a condition of the licence. Would butchers actually need to pass any courses that they attend.

Premises conforming to requirements of the Meat Products Regulations have a possibly greater risk for causing harm over a widespread area, but are not required to have a licence. Is it time to consider licensing these establishments as well.

Support the proposal, which offers the most risk based approach and the most justifiable course of action.

The same 6-month transitional period should be provided in Wales.

Retail butchers in Wales should be sought views on the £100 licence fee. Felt that they will not think it reasonable.

Feel abattoirs should be exempt from licensing.

Appeals should be heard within a short but stated timescale, and be possible on a local basis.

Charity events should be exempt of the licensing requirements.

Would like to see the fee paid with the application, otherwise scarce enough resources are going to be wasted by enforcement officers chasing unpaid fees/pursuing civil debt actions.

£100 licence fee should be reviewed regularly, and set at a level which reflects the true cost of the work.

Now could be the best time to implement Option 2 in the Regulatory Appraisal, to require the licensing of all butchers' shops.

Training costs identified in the Regulatory Appraisal should be one-off costs. Future costs would depend on the need for refresher courses, and the turnover of staff. Total compliance costs should not include these as recurring costs.

Definition of Butcher's shop should be re-defined, otherwise outlets such as 'Spar' selling pre-packed bacon would require licensing.

Unlikely that premises could continuously comply with Regulations. A Code of Practice may be required.

Would not anticipate butchers objecting to the £100 licence fee.