Scottish Government

REGULATORY IMPACT ASSESSMENT ANNEX A

1. Title

1.1 The regulations are to be known as The Meat (Hazard Analysis and Critical Control Points) (Scotland) Regulations 2002.

2. Purpose and Intended Effect of the Measure

2.1 The legislation amends meat hygiene regulations to implement Commission Decision 2001/471/EC. It requires the mandatory use of Hazard Analysis and Critical Control Point (HACCP) principles in licensed red meat and poultry meat plants in Scotland and sets out standard procedures for carrying out certain microbiological tests.

2.2 HACCP is an internationally accepted management system that offers consumers the best guarantee of safe production of food. It provides a methodical, documented, but flexible approach that places responsibility on operators to prevent, eliminate or reduce physical, chemical and microbiological hazards in their food businesses. By applying the seven HACCP principles operators identify the hazards that need to be controlled, establish effective procedures that control the hazards, ensure that these procedures work and are being applied and can provide evidence of their control procedures.

2.3 Regular microbiological testing of carcasses can provide an objective method of demonstrating that the plant's HACCP-based Plan is achieving its aims. Microbiological testing of production surfaces provides a check on the effectiveness of cleaning procedures. The Decision sets requirements for testing carcasses in red meat slaughterhouses and for testing surfaces in red meat slaughterhouses and cutting plants. It also sets performance criteria for assessing the efficacy of plant procedures.

3. Risk Assessment

3.1 The legislation reflects the increased awareness of the risk to consumers from pathogenic micro-organisms that can contaminate meat at all stages from slaughter to consumption and cannot be detected visually. Procedures should focus on reducing contamination of raw meat by microbiological organisms and restricting their growth.

3.2 It is considered that a significant number of people suffer from food poisoning each year. Studies from GP returns in England have indicated that between 17% and 50% of the population suffer from food poisoning each year. Some 40% of these incidents are considered to involve meat. Similar figures would be expected for Scotland.

3.3 In 1999, 82,943 laboratory-confirmed individual cases of food poisoning contracted in the UK were attributed to the three most common bacterial pathogens - Campylobacter (61,713), Salmonella (19,801) and E.coli (1,429). All three can be carried in or on animals and can be transferred to raw meat during production, storage and transport. The greatest impact on meat-borne illness is likely to come from preventative measures on farm, but the implementation of documented HACCP-based systems by meat sector businesses is also important. Such a requirement has already been made part of the butchers' licensing scheme as recommended in the Pennington Report following the fatal E.coli O157 outbreak in Scotland in 1996.

4. Options

4.1 Three options have been considered:

Option 1 - No action

This option would contradict the Scottish Executive's commitment to meeting EU obligations and its support to the HACCP approach to food safety, and has therefore been rejected.

Option 2 - Transposition of the Decision into national legislation

This option would meet EU obligations and implement the requirement for specified meat plant operators to apply HACCP principles in setting up permanent hygiene procedures in their premises without additional prescription.

Option 3 - Set detailed requirements for HACCP in meat plants

Setting more specific HACCP requirements than in the Decision could benefit both industry and enforcement officers. However, since flexibility and operator responsibility are key concepts of the HACCP approach, it would be inappropriate to specify exactly how HACCP principles should be applied, and so this option has not been pursued.

Option 2 is the option being recommended.

4.2 The Decision offers a number of areas of flexibility, which have been taken full advantage of to minimise the burden on industry i.e:

• 12 month delay in implementing the Regulations in small /medium plants, the majority of the largest plants have already implemented HACCP voluntarily or because of customer demand;
• Non-destructive alternative to the excision method of sampling included as a Schedule to the Regulations;
• Reduced frequency of microbiological testing for low throughput plants and those operating less than full time to be established before June 2003;
• Data has been requested from manufacturers on rapid test methods with a view to enabling a potentially more economic method to be approved for handling microbiological testing;
• A Pilot Plant Study has been launched to provide information on the effects on working practices and costs of implementing the legislation;
• Use of guides of good practice is encouraged and the FSA has provided draft guidance to industry and enforcement officers and further information and training material will be supplied particularly to assist the medium/small operators.

These points are discussed in the rest of this paper.

5. Issues of equity and fairness

5.2 The Decision does not provide for any reduction in official controls consequent upon the effective implementation of HACCP principles. The meat industry considers that, while robust enforcement action should be taken against operators who disregard hygiene procedures, operators who can prove that their procedures are effective in controlling hazards to public health (e.g. through satisfactory microbiological results) should benefit from reduced veterinary supervision. The Food Standards Agency supports a risk-based approach to determining the level of official control. Any developments in this area will arise from Commission proposals to amend European legislation on official controls before summer 2002.

5.3 The Decision allows reduced frequency of microbiological testing of carcasses to be set for low throughput red meat slaughterhouses and those operating less than full-time. The Agency will consider the options for reduced testing before the implementation deadline of June 2003.

5.4 Although no standard procedures have been set for poultry plants the Food Standards Agency and the British Poultry Council agree that poultry slaughterhouses and cutting plants should also conduct microbiological tests to check the effectiveness of HACCP and cleaning procedures. The Agency is funding trials on appropriate protocols for use by the industry and to inform any future Commission Decision on poultry testing.

6. Benefits

6.1 Consumers of meat should benefit from a safer product and decreased risk of illness. This should result from a greater emphasis by meat plant operators on control measures that reduce microbiological contamination, and from appreciation of their own responsibility for producing safe meat, rather than the mechanical implementation of legal requirements or reliance on enforcement officers' interventions.

6.2 Operators of meat plants should benefit from an increased awareness of the hazards that need to be addressed and the control procedures that will minimise the risk to consumers. Improved control and monitoring procedures may result in:

• a reduction in reworking or disposal of visibly contaminated product;
• prevention of other problems, such as inadequate chill temperatures, before they become too serious and possibly lead to product recalls;
• increased customer satisfaction.

Documentation of the control procedures and microbiological testing will provide evidence for customers and enforcement authorities that the operator is taking all reasonable measures to produce meat as safely as possible. It is hoped that under a future European risk-based enforcement regime it would be possible to reduce supervision costs in plants where HACCP is being implemented effectively.

6.3 The economy should benefit from increased consumer confidence in the safety of home-produced meat and from reduced medical costs, higher productivity and fewer working days lost as a result of improvements in the microbiological safety of meat.

7. Compliance Costs for Business, Charities and Voluntary Organisations

1. HACCP

Impact on Small Business

8.1 The Report of the Task Force on the Burdens of Food Regulations on Small Food Businesses concluded that there should be no relaxation of standards for small food businesses since consumers have the right to expect the same level of protection irrespective of the size of the business. It is nevertheless recognised that operators of small businesses, and particularly owner-managers, may face additional difficulties in implementing HACCP principles due to their lack of technical expertise and to time pressures both at the outset and for on-going record-keeping.

8.2 Bearing in mind the structure of the UK industry the Agency has proposed a definition of 'small plants' that is considerably wider than the low throughput definition proposed by some Member States. As a result approximately 75% of operators in GB have an extra twelve months to implement the requirements so that as much support as possible can be provided to achieve an effective outcome, such as the guidelines and HACCP Manual. The final part of the Pilot Plant Study is for open days to be held so that other operators can see what implementation will have involved.

8.4 The Decision requires the establishment of documents and records commensurate with the size of the business. The HACCP Manual will provide advice and examples on what might be appropriate.

Other Costs

9.1 The Agency will incur cost in producing training and guidance material for training of enforcement officers. Training in enforcement of the new regulations has been incorporated in the compulsory programme of continuing professional development for official veterinary surgeons in 2002/2003. Training for Meat Hygiene Inspectors is envisaged in the longer term.

9.2 Since April 2002 smaller abattoirs have benefited from the reduced cost of meat inspection which will offset many of the costs incurred by this legislation. Across GB, Government has contributed over £19m to this sector (including a contribution from Scottish Ministers of £0.783m) as a result of this change to the charging regime, which now allows plants to pay either a standard headage rate, or the actual costs of inspection (whichever is lower). Some smaller Scottish plants have seen reductions in inspection charges of approximately 70%.

Results of Consultation

10.1 A Stakeholder Group of representatives of large, medium and small meat industry organisations and other bodies, established in July 2000, advises on the implementation of the Commission Decision. Scottish industry groups have been involved in discussions. Sub-groups have been formed as necessary to look at particular issues.

Summary and Recommendations

11.1 The Agency believes that the application of HACCP principles in licensed red meat and poultry plants and the use of standard microbiological tests will improve the level of microbiological safety of meat for consumers, as well as being of benefit to operators. The HACCP approach is by its nature flexible and needs to be 'owned' by the operator but this legislation makes no changes to the level of official control. Enforcement training is being provided to officials. The Agency would have preferred a longer timetable for implementation but is committed to providing as much guidance as possible to industry, particularly smaller businesses so as to achieve the benefits as economically as possible. An alternative swabbing method of microbiological testing has been approved, subject to review, and consideration is to be given to a proportionate approach to the testing requirements for small plants for June 2003. The implementation of the proposed amendments to meat hygiene legislation is recommended.

Enforcement, Sanctions, Monitoring and Review

12.1 Enforcement of the implementation of HACCP principles and microbiological testing in licensed meat plants would be the responsibility of the Meat Hygiene Service under the existing regulations. Failure to comply with the new requirements would be dealt with by warnings and ultimately by legal action.

12.2 A review of the impact of the implementation of HACCP principles and microbiological testing will be carried out in 2004/5.

CONTACT POINT

Jennifer Howie

Food Standards Agency Scotland

St Magnus House

Aberdeen

AB11 6NJ

Tel: 01224 285 142

fax: 01224 285 168

e-mail: jennifer.howie@foodstandards.gsi.gov.uk

ANNEX 1

PILOT PLANT STUDY

The Agency is conducting a pilot plant study in seven plants across GB to try to assess changes in working practices and resourcing costs of implementing the Commission decision.

In the period to March 2002 three plants had completed the implementation phase of the project. Plant costs have been divided into two categories, time and cash each sub-divided into one-off and on-going costs, as shown in the diagram below.

Note A: One-off time costs of staff training and planning/co-ordination varied in the three plants from £577, £840 to £2,882 (average £1,433). Factors included the gross hourly pay and the effort (in terms of number of hours and employees) put into the training and planning process. This time may reflect the enthusiasm for the task rather than how advanced the plant was before they joined the Study.

Note B: On-going time costs in the two plants that had begun micro-testing and additional record keeping in the period are reasonably similar, giving a weekly average time cost of £15 per week for additional recording, and £35 per week for micro-testing (= £2,600 for 52 weeks).

Note C: One-off cash costs were £107, £144 and £1,249 (average £500) depending on whether equipment was purchased (e.g. a fridge to keep samples), additional overtime was paid, etc. Training and consultancy costs of £2,500 per plant included, as part of the Study, two days off-site training for two staff, half day on-site awareness training for up to 12 staff and 3 consultancy visits.

Note D: The main on-going cash cost is the cost of micro testing. The average cost of micro-testing of carcasses and surfaces in the five Pilot red meat slaughterhouses of £7,500 does not include any allowance for reduced testing after a period of satisfactory results.

ANNEX B

EXECUTIVE NOTE

THE MEAT (HAZARD ANALYSIS AND CRITICAL CONTROL POINTS) SCOTLAND REGULATIONS 2002

Made by Scottish Ministers in exercise of the powers conferred by sections 6(4), 16(1)(b), (d) and (f), 16(3), 17(1), 26(2)(a) and 48(1) of, and paragraph 5(1), (2)(a) and 6(1)(a) of Schedule 1 to the Food Safety Act 1990(), having had regard in accordance with section 48(4A)() of that Act to relevant advice given by the Food Standards Agency and after consultation in accordance with section 48(4) and (4B)() of that Act and by section 2(2) of the European Communities Act 1972() insofar as these Regulations amend the Products of Animal Origin (Import and Export) Regulations 1996() and of all other powers enabling them in that behalf.

Issue

1. Introducing regulations which will apply a risk-based approach to public health protection with the introduction of requirements for HACCP plans and microbiological testing in Scottish meat plants.

Background

1. HACCP (Hazard Analysis and Critical Control Points) is an internationally accepted food safety management system. Its aim is for management to anticipate and prevent problems rather than tackling them when they arise. It is being introduced because of the growing recognition that the main food safety hazards are microbiological pathogens that cannot be detected by visual inspection. The European Commission's Scientific Veterinary Committee's Decision 2001/471/EC of 8 June 2001 requires the implementation of HACCP principles in some 1400 licensed UK meat premises (including 152 premises in Scotland). The Decision also introduces some standard microbiological testing procedures for use by fresh meat slaughterhouses and cutting plants.

1. The Commission Decision Articles and Annex are being implemented through the Meat (Hazard Analysis and Critical Control Points) (Scotland) Regulations 2002, which amend the 1995 Fresh Meat and Poultry Meat Regulations. Similar legislation has been prepared elsewhere in the UK.
2. In order to comply with the Decision the Regulations should come into force on 7 June 2002. However, as permitted by the Decision, the deadline for implementation in 'small' premises is being delayed by 12 months. The UK has taken a pragmatic approach to the definition of 'small' following discussion with stakeholders with the result that fewer than 25% of operators of all meat plants across the GB have to meet the 2002 deadline although they account for over 70% of meat production in GB. In Scotland the definition of 'large' premises, and the structure of the Scottish industry, means that over 30% of red and white meat slaughterhouses will be required to comply this year. All premises have been sent letters to advise them of the category into which they are considered to fall and the implementation deadline that applies.

3. Consultation

4. A HACCP Stakeholder group representing consumer, industry, MHS and other interests was established in July 2001 to advise the Agency on the implementation of the Commission Decision. Scottish industry was also represented on this group.
5. A Scottish consultation was carried out between December 2001 and March this year. Parallel consultations were carried out elsewhere in the UK. A summary of the responses is being placed on the Agency website and a full list of those consulted in Scotland is attached at Annex I.
6. Only a few respondents across the UK did not support HACCP and microbiological testing as a positive step for safeguarding public health. Consumer groups were in favour of the legislation. Industry respondents, including the Scottish Association of meat Wholesalers, generally supported the HACCP concept, but were worried about the additional regulatory burden. There was concern that implementation should be pragmatic and flexible, so that the impact on small businesses should be proportionate, and not threaten their financial viability.

7. Implementation -HACCP

8. The SI does no more than set out the seven HACCP principles laid down in the Decision. Guidance on what these principles are and how they can be applied in meat plants has been sent to operators and Official Veterinary Officers (OVSs).

9. Implementation -Microbiological Testing

10. Microbiological testing of carcasses is an objective way of verifying the hygienic operation of a slaughterhouse. The Commission Decision sets out an excision method of testing which involves the destruction of small pieces of flesh from each tested carcass and is regarded as the 'gold standard' method (Schedule 17A). However Member States are permitted to authorise other testing methods if they provide equivalent verification of plant hygiene.
11. Following discussions with the Commission and other Member States and preliminary results of Agency-funded research, an alternative (swabbing) method has been included at Schedule 17B which better reflects the practises of the UK industry. It is expected that the microbiological performance criteria for this method, currently set at 20% of the values for the excision method, will be reviewed in the light of further research and the results from the large plants over the next 6-9 months.
12. Although poultry plants are being encouraged to use microbiological testing to verify their HACCP plans, the Commission has not proposed any standard methods in such premises so the legislative requirement for microbiological testing covers only red meat slaughterhouses.
13. Cleanliness of meat plants is an essential pre-requisite for the safe production of food and for the application of HACCP principles to meat production and handling operations. The Decision prescribes a method of swabbing for use by red meat slaughterhouses and cutting plants to assess the efficacy of their cleaning and disinfection procedures (Schedule 17C) as set out in the Decision. Poultry plants are being encouraged to adopt the same approach, but there is no mandatory standard.

14. Requirements for 'small' plants

15. The Decision allows Member States to set reduced requirements for low throughput plants and those operating less than full time. The Agency is setting up a sub-committee of the Stakeholder Group to examine the options ahead of the 7 June 2003 deadline for 'small' plants.

16. Training for plant operators

17. Guidance for plant operators is being provided through the production of a Meat Plant HACCP Manual funded by the Agency. This will include guidance on microbiological testing. Primarily aimed at smaller operators and trainers, the Manual will be sent out in late May/early June. It will also be made available as an interactive CD Rom. The Agency has facilitated training for staff from large plants and further initiatives are being considered.

18. Training of Enforcement Officers

19. The Regulations do not alter the duties of officials but add the application of HACCP principles and microbiological testing to the list of operator duties that the MHS is required to enforce. The MHS is already training OVSs from large plants. Training for OVSs from 'small' plants is scheduled for early 2003 and will then be extended to Meat Hygiene Inspectors.

20. Regulatory Impact Assessment

21. Although the industry in Scotland tends to be concentrated in fewer, larger plants there are several very small plants, operating in remote areas processing very few animals per week. The legislation is likely to have a proportionately greater impact on this sector. The Agency is therefore exploring ways in which to assist operators here. Many of the larger plants have already implemented HACCP-based systems and microbiological testing because of customer demands so will have limited extra costs.
22. The legislation also allows for testing frequency, and therefore costs, to be reduced where results are consistently satisfactory. As permitted by the Decision, the Agency plans to set reduced requirements for low throughput plants and those operating less than full time.
23. A Regulatory Impact Assessment has been prepared and is available at the address below.

24. Parliamentary Procedure

25. The regulations are subject to negative resolution procedure, and the 21-day rule applies.

26. Conclusion

27. HACCP and microbiological testing are commonly used in other food production areas and are likely to become an underpinning requirement under the new EU Hygiene Regulations. Their implementation in meat plants should encourage a more proactive approach to food safety management and, in the longer term, provide the basis for an improved risk-based approach to official control.

FOOD STANDARDS AGENCY SCOTLAND

MAY 2002

Contact:

Jennifer Howie, Food Standards Agency, St Magnus House, 25 Guild Street, Aberdeen, AB11 6NJ

Tel: 01224 285100

www.food.gov.uk

CONSULTATION LIST: SCOTTISH INTERESTED PARTIES ANNEX I

ASSOCIATION OF PUBLIC ANALYSTS IN SCOTLAND

ASSOCIATION OF MEAT INSPECTORS

BRITISH POULTRY COUNCIL

BRITISH MEAT FEDERATION

BRITISH MEAT MANUFACTURERS ASSOCIATION

COLD STOREAGE AND DISTRIBUTION FEDERATION

FOOD CONTROL CONSULTANCY

FOOD INDUSTRY FORUM

GRAMPIAN COUNTRY FOOD GROUP LTD

GLASGOW COLLEGE OF FOOD TECHNOLOGY

GLASGOW VET SCHOOL

HEALTH AND SAFETY EXECUTIVE

HIGHLANDS AND ISLANDS ENTERPRISE

INDEPENDENT FARMING GROUP

JOSEPH MITCHELL (LETHEM)

MCINTOSH DONALD LTD

NFU/S

QUALITY MEAT SCOTLAND

REHIS

ROYAL DICK VETERINARY COLLEGE

SCOTTISH AGTRICULTURE COLLEGE

SCOTTISH ASSOCIATION OF MEAT WHOLESALERS

SCOTTISH BRANCH OF BRITISH VET. ASSOCIATION

SCOTTISH CENTRE FOR INFECTION AND ENVIRONMENTAL HEALTH

SCOTTISH CHAMBER OF COMMERCE

SCOTTISH CTTEE OF THE COUNCIL ON TRIBUNALS

SCOTTISH CONSERVATIVE AND UNIONIST PARTY

SCOTTISH CONSUMER COUNCI

SCOTTISH CROFTERS UNION

SCOTTISH ENTERPRISE

SCOTTISH FEDERATION OF MEAT TRADERS ASSOCIATION

SCOTTISH FOOD AND DRINK FEDERATION

SCOTTISH GREEN PARTY

SCOTTISH LABOUR PARTY

SCOTTISH LIBERAL DEMOCRATS

SCOTTISH MEAT INDUSTRY LIASION GROUP

SCOTTISH NATIONAL PARTY

SCOTTISH ORGANICS PRODUCERS ASSOCIATION

SCOTTISH RETAIL CONSORTIUM

SCOTTISH SOCIETY FOR THE PREVENTION OF CRUELTY TO ANIMALS

THE SCOTTISH BEEF COUNCIL

THE SCOTTISH COUNCIL FOR DEVELOPMENT AND INDUSTRY

THE SCOTTISH FOOD SAFETY OFFICERS ASSOCIATION

THE SCOTTISH FOOD CO-ORDINATING COMMITTEE

ROWETT RESEARCH INSTITUTE

UNIVERSITY OF STRATHCLYDE

UNISON