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The UK contingency plan for the emergence of naturally occurring BSE in sheep

June 2004

Department for Environment, Food and Rural Affairs Nobel House 17 Smith Square London SW1P 3JR Telephone 020 7238 6000 Website: www.defra.gov.uk

© Crown copyright 2004

 This publication (excluding the logo) may be reproduced free of charge in any format or medium provided that it is reproduced accurately and not used in a misleading context. The material must be acknowledged as Crown copyright with the title and source of the publication specified.

Further copies of this publication are available from:

Defra Publications Admail 6000 London SW1A 2XX Tel: 08459 556000

Contents

Purpose of plan Background The EU dimension Age cut offs: The disease ScopeLegal powers Activating the plan

Scenario on which this plan is based

Action on flock origin Command and control Communications Operating the plan Genotyping and associated controls Disposal of animals Implementation issues

Identification of sheep keepers Age verification Imports and exports Compensation and other financial assistance

Table of responsibilities Draft partial Regulatory Impact Assessment

Paragraphs 1-3
Paragraphs 4-9
Paragraphs 10-13
Paragraphs 14-15
Paragraphs 16-21
Paragraphs 22-29
Paragraphs 30-35
Paragraphs 36-43

Paragraphs 44-46
Paragraphs 47-49
Paragraphs 50-54
Paragraphs 55-58
Paragraphs 59-61
Paragraphs 62-70
Paragraphs 71-76
Paragraphs 77-85

Annex A Annex B

Purpose of plan

1. 1. This contingency plan sets out the UK Government’s strategy for responding to the finding of naturally occurring BSE in sheep1, and the measures which, based on current knowledge and expert advice, are likely to have to be taken. The purpose of these measures would be to protect public health, to safeguard animal welfare, and to manage the impact on the sheep sector and the environment. Our aim is to enable the sector to recover and supply the food chain as quickly as practicable. This plan also meets a requirement of EU Regulation 999/2001 for member states to draw up contingency plans specifying the measures they would implement where cases of Transmissible Spongiform Encephalopathy (TSE) diseases, such as BSE and scrapie, are confirmed in small ruminants, i.e. sheep and goats.

2. 2. This plan is unlike the contingency plan recently published on foot and mouth disease2. BSE in sheep would be a different type of disease and would not require the same speed of response. Detailed operational plans will be written to accompany this document and will cover the sort of details which can be seen in the FMD plan for example.

3. 3. This plan should be regarded as a living document which will be subject to changes. It will need updating in the light of developments and emerging science, for example, in genotyping and testing, or if EU regulations are put in place. It will also need to reflect any changes in the underpinning risk assessment of BSE in sheep. We will review the plan at six-monthly intervals or more frequently, if necessary, in the light of such developments.

Background

1. 4. The report of the BSE Inquiry in October 2000 noted that the UK Government had failed to prepare for the link between a new variant of CJD and BSE. In its response to the Inquiry in September 2001, Government recognised the importance of effective contingency planning and accepted responsibility for ensuring an appropriate level of preparedness to protect public health. This contingency plan is an essential element of that preparedness, for the possibility of BSE in sheep.

2. 5. An interdepartmental working group, led by Defra (then MAFF) was established with the following terms of reference:

‘In agreement with all interested bodies within Government, and taking into account the European Union dimension, to produce an integrated contingency plan of the actions to be taken should the presence of BSE in sheep be confirmed and should that lead to a total or partial ban on the consumption and export of sheep meat produced in the United Kingdom.’

1 Unless indicated otherwise references to sheep include goats. There are currently around 90,000 goats in the
UK on approximately 9,000 holdings.
2 Defra news release 120/04 of 31 March 2004.

1. 6. An initial draft contingency plan was issued for public consultation in September 20013. It described a list of possible actions to enable the UK Government to respond flexibly and quickly to the wide range of scenarios that might apply if BSE were found in sheep. These included genotyping sheep, and extending existing Specified Risk Material (SRM) controls and (as a worst case scenario) the slaughter and disposal of the entire national flock.

2. 7. Key factors since then, which have influenced our work on this plan, are activity by the Food Standards Agency (FSA) and the Government's advisory committee on transmissible spongiform encephalopathies (SEAC), and EC guidelines on contingency planning for BSE in small ruminants4.

3. 8. Following a public stakeholder meeting in December 2001, the FSA established a core stakeholder group to consider, in the light of continuing scientific uncertainty, whether any further precautionary measures should be taken in relation to BSE and sheep. The group’s findings were put to the FSA board following public consultation on its report. In June 2002 the board considered and accepted the Group’s report5 which, amongst other things, set out the Agency’s probable advice in the event BSE was found to be present in the national flock.

4. 9. This contingency plan has been written in the light of the FSA's recommendations and of responses received on the earlier draft contingency plan.

The EU dimension

1. 10. This contingency plan sets out action to be taken by the UK Government. However, if the presence of BSE is confirmed in sheep, it is likely that the EC would put measures in place to deal with this on an EU-wide basis. These measures would be introduced through the Standing Committee on the Food Chain and Animal Health (SCoFCAH).

2. 11. Some elements of this plan may form part of EU-wide controls. Discussions are in progress with the EC to establish the likelihood and nature of any such controls. In the meantime, the basic orientation of our plan is in line with the EC guidelines. The EC are keen to avoid unilateral measures by member states and wish to see a harmonised and proportionate response based on the best available scientific advice. SCoFCAH would play a key role in harmonising and co-ordinating the EU-wide response.

3. 12. The EC have confirmed that in the event of a positive finding of BSE in sheep they would rely heavily on expert scientists, in particular the so-called expert panel, which would be called in a matter of days. There would also be close liaison between the EC and the European Food Safety Authority (EFSA).

3

A copy of this plan can be found at: http://www.defra.gov.uk/corporate/consult/sheepbse/sbseplan.pdf 4 Contingency planning for the confirmation of bovine spongiform encephalopathy (BSE) in small ruminants. SANCO/19/2003 Rev.2 Working Document. 10 April 2003. Copy available from Defra on request.

5

A copy of the draft report of the core stakeholder group can be found at: http://www.food.gov.uk/foodindustry/Consultations/completed_consultations/completeduk/bsesheepstakeholderre port

13. The disposal elements of this plan are in line with the relevant EU legislation, in particular the EU Animal By-Products Regulation (EC) No.1774/2002 (ABPR) and the Waste Framework Directive (Council Directive 75/442/EEC as amended) (WFD).

Age cut offs: differences between SEAC advice and EC Commission guidelines

14. This plan is based on SEAC recommendations which differ from the EC guidelines in one significant respect, namely the age cut offs for animals that would be permitted into the food chain. The EC guidelines state, as a worst case scenario, that if BSE were found in sheep only the following animals would be allowed into the food chain:

. • ARR homozygous6 sheep under 18 months of age

. • ARR heterozygous7 sheep under 6 months of age

The most recent advice from SEAC (November 2003) has confirmed that if BSE were found in sheep, their advice would continue to be that only animals carrying the ARR allele should enter the food chain, i.e. ARR homozygous and heterozygous. This is in agreement with the EU guidelines. However, SEAC advise that the following animals would be safe to enter the food chain:

. • ARR homozygous sheep of any age

. • ARR heterozygous sheep under 12 months of age.

15. This is a significant difference between this plan and the EC guidelines and it has wide ranging implications for current practice in our industry as regards the age at which lambs are slaughtered for food. The EC recognises the importance of this and have agreed that they would ask EFSA to review their advice on the age cut offs on which the guidelines are based.

The disease

1. 16. There is an EU-wide requirement to undertake surveillance for scrapie and such a programme is in place in the UK at present. From January 2004 the UK has to test 10,000 sheep over 18 months of age (slaughtered for human consumption) and 10,000 fallen sheep. Similar test requirements exist for goats but on a smaller scale, respectively 240 and 500 animals. All current field cases of confirmed scrapie in the UK are tested for the presence of BSE.

2. 17. The present situation is that BSE has not been identified as occurring naturally in sheep. However, there is a theoretical risk of BSE being present in sheep, because sheep consumed the same feed which is thought to have given cattle BSE and research has shown that sheep can be experimentally infected with BSE.

3. 18. Experimental8 BSE affects sheep in a different way to BSE in cattle and this would be reflected in how the situation would be handled should BSE be found naturally occurring in sheep. For example, the scientific evidence indicates that the development of infection and the distribution of BSE infectivity through the body of a sheep would be more extensive than in cattle. That is why specified risk material (SRM) controls9 alone would not be sufficient to protect human health, in the case of sheep meat.

4. 19. There is limited data relating to goats but available research indicates that the behaviour of natural scrapie in goats is similar to that in sheep. Any action in response to BSE in sheep would, therefore, be extended to goats – except genotyping, because no genotypes have been found which make goats naturally resistant to scrapie and (so far as we know) BSE.

5. 20. Lymphocytes (white blood cells) are found in milk and unlike in cattle, lymph nodes in sheep can carry BSE infectivity (as shown in research on experimentally infected sheep). The FSA core stakeholder group report identified that sheep dairy products, including milk, could be a source of infectivity. That means any measures introduced, or advice given, in relation to meat would be likely to apply also to such products.

6. 21. It should be noted that there is currently no reliable test for BSE in sheep. Scientific work is continuing to develop acceptable tests. Therefore, it is not possible at present to base a risk management strategy around such tests, to allow only sheep testing negative for BSE to enter the food chain.

6 ARR homozygous = fully resistant. 7 ARR heterozygous = semi resistant.

Scope

1. 22. This contingency plan deals mainly with sheep that would be on farmers’ holdings at the time action became necessary, and with measures to ensure that BSE is eliminated from the national flock. There would be no need for measures such as those taken to control the spread of foot and mouth disease, as BSE is not a highly infectious exotic disease. This is an important distinction which would determine both the nature and the pace of the Government’s response.

2. 23. More detailed operational plans are being prepared to set out actions and procedures for the relevant administrations throughout the UK. These are consistent with the overall strategy set out in this overarching plan.

3. 24. This plan does not deal with sheep meat and sheep products that would already be in the food chain at the time when action becomes necessary. It would fall to the FSA, if necessary, to co-ordinate the withdrawal of these from the food chain. To this end, the FSA have commissioned a research project to determine which products for human consumption utilise any part or product of sheep. The results of this work, expected in the next few months, will assist in defining the categories of food product which may contain sheep material and may need to be withdrawn.

8

Experimental BSE is artificially or purposely infecting sheep with BSE from cattle brains

9

Current SRM for sheep and goats in EU – spleen and ileum(all ages); skull including brain, eyes, tonsils, spinal cord (animals over 12 months).

Information currently available suggests that sheep material is not used in as wide a range of food products as beef derivatives.

1. 25. Defra has commissioned a parallel study into the non-food uses of sheep and goat products in the UK. This study will include uses such as sheep wool and hair, leather, pet food, horn and serum. It will exclude human and veterinary medicinal/medical uses which are covered by specific guidelines on minimising the risk of transmitting TSEs. The study is expected to be completed in summer 2004. This plan will be updated as necessary to take account of this study and any expert advice on its findings. DTI would be responsible for any action/advice needed in relation to these products.

2. 26. The Departments of Health would be responsible for any action/advice needed in relation to medicinal/medical products that contain ovine/caprine material.

3. 27. The Veterinary Medicines Directorate would be responsible for any action/advice needed in relation to veterinary products that contain ovine/caprine material.

4. 28. Together with a possible immediate ban on slaughter for the food chain, and any immediate action needed on farms with affected animals, the possible withdrawal of food and non-food products from sale, use or consumption would be the only urgent consumer safety action that might have to be taken. If necessary, the FSA would invoke standing arrangements to implement this removal through local authorities.

5. 29. The disposal of withdrawn sheep meat and sheep products must meet the requirements of the ABPR and the WFD. Defra/ DAs/FSA will liaise with their respective environment agencies about the regulatory requirements and environmental impact of the management and disposal, as waste, of withdrawn food and non-food products. Any other wastes generated by the implementation of the contingency plan must also be disposed of in accordance with the relevant regulatory requirements and without endangering human health or causing harm to the environment.

Legal powers

1. 30. The emergency withdrawal of items from the food chain would be covered by the Food Safety Act 1990.

31. The Animal Health Act 2002 gave the Secretary of State a number of new powers in relation to England and Wales that would be invoked should this action plan be implemented. In particular the Act inserted a new Part 2A into the Animal Health Act 1981 that contains the powers available to the Secretary of State to implement a genotyping scheme. Section 36A of that Act allows the Secretary of State to specify by Order the sheep genotypes that are, in her opinion, most susceptible to either infection by a TSE or to becoming carriers. Once a sheep’s genotype has been declared by such an order, 'restriction notices' can be issued to ban breeding as necessary. The keeper of the sheep would have to arrange for each animal to which the notice applies to be castrated, or sterilised as

appropriate or slaughtered.

2. 32. In Scotland the Scottish Executive has undertaken initial consultations on taking powers similar to those included in the Animal Health Act 2002 to respond to the natural occurrence of BSE in sheep. In Northern Ireland work is underway to develop an Animal Health Bill that will include similar powers. In the eventuality that BSE in sheep was proven to exist before the respective Bills have completed their Parliamentary passage, Scottish and Northern Ireland Ministers would be ready to introduce emergency legislation to give them additional powers to respond to the situation.

3. 33. The Animal Health Act 2002 also gives powers for slaughter in England and Wales which could be used in implementing this plan.

4. 34. The Environmental Protection Act 1990 and the Waste Management Licensing Regulations 1994 confer on the environment agencies regulatory powers for the management and disposal of waste and associated environmental impacts presented by implementing this plan.

5. 35. The Animal By-Products Regulation 2003 is the enforcing regulation for the ABPR. The regulation is enforced by the Meat Hygiene Service in licensed slaughterhouses and cutting plants and by local authorities elsewhere. The issuing of approvals is the responsibility of the State Veterinary Service. Although the Environment Agency has no enforcement role in relation to the ABPR, it is responsible as the competent authority for the purposes of the WFD for the enforcement of environmental legislation mentioned above which impacts on the disposal of waste animal by-products.

Activating the plan – procedures and possible scenarios

1. 36. This plan is based on current scientific advice and existing tests. Both may change and the plan will be regularly reviewed and updated in the light of possible new advice from the FSA informed by their risk assessment work or improved diagnostic tests. Of particular relevance is work by the EU on a procedure for screening naturally occurring cases of scrapie, to differentiate between scrapie and BSE, by means of a combination of two or more rapid tests. These tests are currently being evaluated at EU level by means of a ring trial being run by the Community Reference Laboratory for BSE (based at the Veterinary Laboratories Agency, Weybridge). It is hoped that the results of the evaluation work and follow up scientific work might be available during 2004. This work could lead to a fresh assessment by the expert bodies, particularly in the light of results obtained to date using such tests.

2. 37. Pending these developments, the plan is based upon the following expectations of the most likely events – nationally and internationally – which would require some or all of the measures set out in the plan to be activated, proportionate to the level of risk presented.

. • A suspect10 case awaiting confirmation in UK/and if known in a member state/third country

. • A case being confirmed in UK/member state/third country

. • Historic/multiple case(s) in the above categories

1. 38. The particular response would be governed by the individual circumstances of the trigger event and advice on the level of risk. Any risk assessment would need to take into account both the actual test results and the potential level of exposure to BSE infectivity, based on the latest scientific data. In the UK SEAC would be convened as soon as practicable following notification of a suspect or confirmed case. SEAC would then provide an assessment of the risk in the UK. The agency responsible for risk assessment within the EU is EFSA. The EC have confirmed that they would involve EFSA in formulating an EU-wide response.

2. 39. In response to the advice on the level of risk the FSA would:

. • advise Ministers/ consumers on the safety of sheep meat and sheep products.

. • if considered necessary, co-ordinate the withdrawal of food products from the market.

. • liaise with the EC/EFSA to determine what action is being taken at the EU level.

. • liaise with the Department of Health and Local Authorities on necessary action.

1. 40. The UK Government, the devolved administrations and other relevant organisations, would respond to the risk assessment and advice from the FSA. Defra's chief scientific advisor would have a role in the validation of the science of the testing process and in ensuring that any response to a positive finding was scientifically sound.

2. 41. Possible scenarios, depending on the severity of the assessed risk are as follows:

. • The risk is assessed to be acceptably low, based on either the calculated prevalence of BSE or the lack of confidence in the finding, and that no restrictions on sheep meat or products entering the food chain are appropriate at the time.

. • Withdrawal of sheep from the food chain unless it can be shown they are of the appropriate genotype and age.

. • Withdrawal of all sheep from the food chain.

1. 42. Although a possibility, the withdrawal of all sheep from the food chain is, however, a highly unlikely scenario. It is not consistent with the current SEAC/FSA advice. Furthermore, as noted in paragraph 14, the EC guidelines do not envisage a total ban as the worst case scenario.

2. 43. The potential prevalence of BSE in the sheep flock could be estimated from the numbers of tests carried out on sheep brains from the TSE surveillance programme. These calculations may suggest a very low prevalence and therefore a very low risk. Alternatively, there may be sufficient uncertainty in the interpretation of the positive test results that again the risk would be considered to be very low. Under these circumstances the FSA decision could be to put the details of what was known into the public domain, in line with its policy about

Suspect case means a case clearly resembling experimental BSE in sheep.

being open about uncertainty, and at the same time determine an appropriate risk management strategy and provide suitable advice to Ministers and consumers.

Scenario on which this plan is based

44. The FSA has previously stated the following position11:

‘At the current state of knowledge, if BSE were shown to be present in the national flock, then the Agency's advice would be that only sheep which could be clearly demonstrated to be free of BSE could be allowed to remain in the food chain. This would mean that UK sheep could no longer enter the food chain unless identifiable as genetically resistant.’

1. 45. SEAC recommended a risk management strategy in 200112. Only sheep of a most resistant genotype (ARR homozygous) or of a semi resistant genotype (ARR heterozygous) if under 12 months should be allowed into the food chain if BSE is found to occur naturally. This strategy was reconfirmed at the SEAC meeting on 24 June 2003 and again in November 2003 (see paragraph 14). This contingency plan is predicated on such a risk management strategy. However, as noted in paragraph 14, the Commission guidelines are based on different age cut offs. We are working with the Commission to resolve this matter.

2. 46. The overarching aim of this contingency plan is therefore to establish rapid, practicable and cost-effective methods for using genotyping to set up a flock or progeny certification scheme. The objective of such a scheme would be to maximise the number of animals that can be permitted to enter the food chain in the short to medium term; and rebuild the UK sheep industry in the medium to long term. The genotyping programme would be run in parallel with a phased disposal programme.

Action on flock of origin

1. 47. Where a case of naturally occurring BSE was confirmed in sheep flocks, immediate action would need to be taken on the flock of origin and contact. The EU TSE regulation (999/2001) and amendments, most recently 1915/2003, sets out detailed provisions for control and eradication of TSEs in sheep and goats that would apply in such circumstances.

2. 48. Once the presence of BSE has been officially confirmed, the holding on which the animal is present would be placed under official control and movement of all animals susceptible to TSEs and products of animal origin derived from them, subject to authorisation to ensure immediate tracing and identification of animals and products of animal origin. An inquiry then has to be carried out to identify all animals at risk. This must identify all ruminant animals on the holding, and, if identifiable, parents, and in the case of females their embryos, ova and last progeny of the animal in which the disease was confirmed. It must also identify other holdings on which there are animals that may have become infected by the agent or have been exposed to the same feed or contamination source, and the

12 http://www.food.gov.uk/multimedia/pdfs/bsesheepstakeholdergroup.pdf www.seac.gov.uk/summaries/summ_0201.htm

movement of potentially contaminated feedstuffs, other material or any other possible means of transmission of the BSE agent to or from the holding in question.

49. All animals, embryos and ova identified by the inquiry (except for non ovine or caprine ruminant animals, i.e. bovine animals on the holding where the disease was confirmed) have to be killed and completely destroyed, as specified risk material. Similar action has to be taken in the case of flocks/herds affected by scrapie, except that there is the option of killing/completely destroying only animals of the less resistant genotypes.

Command and control

1. 50. On confirmation of a case of naturally occurring BSE in sheep the FSA would advise both the public and relevant Ministers about appropriate action to take to protect public health. Defra would form the BSE in Sheep Programme Board with relevant interests immediately, to co-ordinate the UK response and a programme manager appointed with support team. However, it is possible that Defra might convene the Programme Board at the point when a suspect case is identified.

2. 51. The Programme Board would also be advised by a core external stakeholder group (a group representative may be invited to attend the programme board meetings as an observer). Board meetings would initially be held weekly/twice weekly and the frequency reviewed in the light of circumstances.

3. 52. Day to day responsibility for managing the overall response to BSE in sheep would be held by Sustainable Farming, Food and Fisheries Directorate General, in partnership with the devolved administrations. Operational aspects of the response will be delivered through the SVS (genotyping) and the RPA (disposal), and other relevant authorities as applicable.

4. 53. Significantly, due to the nature of the response and the fact that BSE is not a highly infectious animal disease, there would in principle, be no need for disease emergency control centres (DECC) or the appointment of regional operations directors (RODs). There would be a role for Government offices in terms of communication and feedback but they will not be required to respond operationally.

5. 54. Annex A sets out the roles and responsibilities of the relevant authorities.

Communications

1. 55. It will be crucial for Defra and the devolved administrations (DAs) to communicate clearly, openly, proactively and in a timely fashion, both internally and externally, to ensure there is a measured and informed response to what could potentially be a very serious and unprecedented situation.

2. 56. There would be three broad stages in the process to confirm, and react to, a finding of naturally occurring BSE in sheep.

. • Stage 1 – from notification of suspect case, and before confirmation, as necessary, by multi-laboratory ring trial.

. • Stage 2 – after confirmation of finding, by multi-laboratory ring trial as applicable, and before consideration by SEAC, and subsequent advice from FSA.

. • Stage 3 – after advice from the FSA and setting out action plan to be implemented by Defra and DAs.

Government will wish to keep interested parties informed of developments. The precise nature of any communication will depend on circumstances at the time, and on what Ministers decide, taking account of any scientific uncertainties and Government policy on openness.

1. 57. Defra and DAs would immediately establish core external stakeholder groups for communication and liaison between Government and key external stakeholders. The News Co-ordination Centre of the Cabinet Office will be involved at all stages to ensure a consistent message is presented across Government. In addition Defra and DAs would arrange to communicate with a wider group of interests, particularly the farming and associated industries on a regular basis by way of circulars, notices, letters, etc.

2. 58. A more detailed communications strategy will form part of the operational plans referred to in paragraph 23. The communications strategy will be linked to those of other Government departments, notably the Food Standards Agency and the Department of Health.

Operating the plan

(Based on the risk management strategy in paragraph 45)

1. 59. On confirmation of naturally occurring BSE in sheep, and depending on the time of year in the sheep breeding cycle, it is possible that a temporary ban on the breeding of sheep may be imposed. Depending on FSA advice there may be certain exemptions, such as for those flocks producing slaughter lamb which exclusively use most resistant rams, or for certain rare breeds.

2. 60. However the speed of response would need to take account of conditions on the ground. A crucial variable would be at what time of year the disease is confirmed. A ban on slaughter for the food chain would soon lead to welfare issues if a large number of sheep were on farms (e.g. after lambing).

3. 61. Once the initial immediate controls (breeding ban as necessary, and food chain ban) had been put in place the effort put into genotyping (currently carried out as part of the National Scrapie Plan and Northern Ireland Scrapie Plan) would be escalated.

Genotyping and associated controls

1. 62. The genotyping and associated controls to be activated under this plan would build on what has already been achieved under the National Scrapie Plan (NSP) and the Northern Ireland Scrapie Plan (NISP). Measures already under way to meet the requirements of EU legislation for scrapie eradication13 would underpin this plan.

2. 63. The NSP/NISP are long term voluntary initiatives to eradicate scrapie from the national flock through a programme of genotyping and selective breeding under which breeding sheep which are genetically susceptible to scrapie are removed over time and replaced by sheep with greater levels of resistance. The plans implement a recommendation from the Spongiform Encephalopathy Advisory Committee’s report on Research and Surveillance for TSEs in sheep for a long term control and eradication programme for scrapie. The aims of the plans are to reduce and eventually eliminate scrapie from the national flock, thereby reducing the risk to human health from the possibility of BSE in sheep, if it is there and being masked by scrapie. Designed to target breeding ram production, the NSP/NISP’s Ram Genotyping Schemes are open to all pure bred flocks engaged in ram production. Compulsory breeding for scrapie resistance in flocks of high genetic merit will become an EU requirement from April 2005.

3. 64. Uptake of the NSP has been encouraging. As of May 2004, over 10,000 purebred flocks have been entered into the NSP’s Ram Genotyping Schemes, with some 935,000 animals genotype tested since 2001. This figure is forecast to increase further to around one million animals tested by the summer of 2004. Of those animals tested, some 30% are of the most resistant ARR/ARR genotype with a further 45% carrying one copy of the resistant ARR allele accounting for some 75% of all genotype test results. In Northern Ireland there are approximately 1200 purebred flocks and over 50% of flock owners have joined the NISP Ram Genotyping Scheme. Of the 31,500 animals tested some 23% are of the ARR/ARR genotype, with a further 42% carrying one ARR allele. The increasing level of membership in both NSP and NISP by the ‘top-tier’ of the breeding ‘pyramid’ is very encouraging. Increases in the production of TSE resistant purebred rams from such flocks for use elsewhere (both for further breeding and in commercial flocks producing prime ‘slaughter lambs’) will have a positive effect on the future levels of genetic resistance in both the breeding sector and the slaughter lamb population.

4. 65. Additional initiatives under the NSP/NISP include the Voluntary Scrapie Flocks Scheme to assist farmers, who have had a case of scrapie confirmed on their holding between July 1998 and summer 2004, to take action to prevent further cases of scrapie emerging from their flock, and thereby reducing the level of scrapie infection in the national flock. From summer 2004, EU-wide scrapie control measures will be enforced, under the Compulsory Scrapie Flocks Scheme. A framework for the recognition of the TSE resistant status of flocks of sheep will be launched during the course of 2004 (to comply with EU decision

Commission Decision of 13 February 2003 (2003/100/EC) laying down minimum requirements for the establishment of breeding programmes for resistance to transmissible spongiform encephalopathies in sheep. OJ L041. 14/02/2003. Pages 41-45.

2003/100/EC). The framework will be open to all flocks within the NSP/NISP and, in addition, to those commercial flocks using NSP/NISP tested male breeding stock for crossbred production including fat lambs destined for the human food chain.

1. 66. The National and Northern Ireland Scrapie Plan Administration Centres would manage all aspects of genotyping involved with this contingency plan. A targeted approach will be taken to genotyping, which reflects the stratification and dynamics of the UK sheep industry. The genotyping programme would require a different approach for each different sector of the industry, e.g. hill and lowland flocks.

2. 67. This genotyping programme will increase the overall numbers of most resistant and semi-resistant breeding animals which can be retained for further breeding to replace those animals which are less resistant. The objective is to increase the number of most resistant rams from which progeny can be bred for the regeneration of the purebred breeding sector in the next breeding season and thereafter for the production of more genetically resistant slaughter lamb.

3. 68. A system of certifying producers supplying sheep for breeding or for slaughter for human consumption will be established. Producers supplying the food chain will only be permitted to use ARR/ARR rams for the production of slaughter lamb, thus ensuring the progeny will carry at least one copy of the resistant gene. This is in line with Commission Decision 2003/100/EC mentioned at paragraph 65.

4. 69. Dependent on genotyping capacity available and time of year it may be possible to arrange targeted testing of a small proportion of lambs prior to entry to the food chain if there was market demand while a certification system is established. There would be no need to genotype ewes in the great majority of flocks or to genotype most lambs destined for the food chain – once the certification scheme was in place.

5. 70. Control arrangements would be introduced to preserve the integrity of certified flocks and guarantee the genotype of animals which go into the food chain.

Disposal of animals

1. 71. The disposal of carcases must meet the requirements of the ABPR. This provides that the disposal methods for animals suspected of being infected by a TSE or for animals killed during TSE eradication measures, are rendering followed by MBM incineration.

2. 72. The disposal scheme would be co-ordinated centrally by RPA, working closely with the SVS, local authorities, EA/SEPA and devolved administrations (DAs) for local support and delivery. DAs would agree protocols with RPA, EA/SEPA, SVS and Local Authorities on who does what and these would be detailed in the operational plans. The RPA would issue collection notices to farmers and organise transport to, and booking in with, abattoirs, to manage throughput. Gathering/assembly points may be required in remote areas.

3. 73. Farmers would have to declare the numbers of animals on their holdings, and notify the RPA of any significant changes on the period after their initial declaration and before they receive their collection notices. Farmers would have at least 3 weeks’ notice to gather their animals for collection. Records of animals collected and slaughtered, as well as of the weight of carcases rendered, would be kept for audit purposes. Payments to hauliers, slaughterers, renderers and other contractors would be handled by the RPA. Animals would have to be presented for slaughter in a condition otherwise fit for human consumption, and in compliance with relevant welfare standards.

4. 74. In general the standard disposal route would involve dedicated slaughter in de-licensed abattoirs, rendering, MBM and tallow disposal. The scheme would operate to the limit of rendering capacity available at the time. There would be no landfilling. Animals would be skinned after slaughter so as not to adversely affect the rendering process, and the skins incinerated (if a market cannot be found for them, as it is unlikely they could be landfilled).

. 75. The animals to be disposed of would be:

. (i) All lambs born or conceived before flock or progeny certification is established. Such animals would normally be destined for human consumption but in this case could not go into the food chain. This would make up the bulk of the disposal programme in the first year or so. Numbers will vary from 14 million to 23 million depending on the time of year and on the number of ewes which had been tupped. Because there would be no certified flock or progeny scheme at the time a ban on slaughter for the food chain was introduced, all of these lambs would have to be disposed of. Exceptions to this could depend only on the genotype of the animals. If any such lambs are tested and found to be an appropriate genotype they could go either into the breeding flock or into the food chain.

. (ii) Non-resistant adult rams and shearling rams normally used to sire lamb for the food chain. Genotyping would determine the numbers and timing of this. To prevent unwanted breeding from non-resistant rams these animals would have to be genotyped tested and slaughtered as a matter of priority, or alternatively be isolated or castrated. Estimated numbers for disposal range from 0.3 million to 0.4 million.

. (iii) All cull ewes. There would be no need to accelerate the culling of ewes, and arrangements for this part of the disposal programme would be less urgent. These would be dealt with along the lines of the current over thirty-month scheme for cattle. Around 2 million animals would be involved on an annual basis. Cull ewes, which could be certified as being of the most resistant type, could in principle go into the food chain.

5. 76. Provision would be made for on-farm slaughter in limited circumstances where welfare issues or practical difficulties make it necessary.

Implementation issues

Identification of sheep keepers

1. 77. In order to implement this contingency plan the relevant authorities will need to contact all sheep keepers. There will be extensive publicity to invite sheep keepers to make themselves known (to RPA and SVS). However, Government will need to make initial contact using available data sources. All sheep keepers, including hobby farmers, should have registered with the SVS (for Great Britain) and DARD (for Northern Ireland) but it is suspected that the databases may not cover absolutely every sheep keeper.

2. 78. The proposed electronic ID system for individual sheep tracing is unlikely to be in place before 2008. In the meantime, each department will need to update its existing database of keepers to implement this plan. The main data is on the VETNET/DCS register (for Great Britain) which holds data on sheep owners and associated holdings collected in compliance with the Sheep and Goats Identification and Movement Order 2002. Similar data is held in Northern Ireland on a contacts database. Work is underway to incorporate this database into APHIS by July 2004. Other data will come from the animal movement licensing system (in particular to pick out 'active' sheep farms), the sheep annual premium claims database and the Census database. Other sources of information about sheep keepers are the National Scrapie Plan and Northern Ireland Scrapie Plan databases, the British Wool Marketing Board, and the Scottish Animal Movement Unit (SAMU) in Scotland which, since 18 February 2002, has required all sheep to be tagged with a unique number when moving from one holding to another.

Age verification

1. 79. There would need to be age checks for semi-resistant sheep entering the food chain. The FSA have stated that in the absence of any other animal identification or tracing system they would, subject to advice from SEAC, accept dentition checks as a means of determining the age of sheep. Current precautionary SRM controls on sheep rely on one permanent incisor, which has erupted through the gum, as the confirmation that sheep are over twelve months of age.

2. 80. However, if the presence BSE in sheep is confirmed, dentition checks may be insufficiently reliable, as permanent incisors can erupt as late as fifteen months. One of the questions on which SEAC advice would be sought at the earliest opportunity would be the level of risk that might be posed by such older sheep.

3. 81. If SEAC advice resulted in a decision not to rely solely on dentition checks, we would need to rely on other means. However, there is currently no means of determining the exact age of individual animals. Therefore, alternatively, a decision could be taken, for example, to allow into the food chain only animals which are slaughtered before 31 December in the year of their birth.

Imports and exports

82. Experience with cattle BSE indicates that increased checks would be required to ensure that only safe products were being exported. The same safeguards would need to be applied to imports, as necessary.

Compensation and other financial assistance

1. 83. It is likely that member states would be expected to provide their farmers with some form of compensation and other financial assistance. This is in accordance with the spirit of EC Regulation 999/2001 (laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies) and the information in the Commission guidelines for contingency planning for BSE in small ruminants. This would be intended to compensate for the destruction of animals and products, for the exclusion of certain animals from the food chain, and for the obligation to hold animals which have no market value until disposal.

. 84. If BSE is found in the sheep flock, Government would need to decide on the nature and extent of the compensation it provides. It would also need to consider whether to introduce a wider aid package for sheep farmers. Such a package could have a number of objectives:

. • to encourage farmers to retain sheep to the proper welfare standards pending disposal, under a phased disposal programme. The welfare of animals will need to be maintained.

. • to support re-establishment of a sheep industry through the use of TSE
resistant sheep stock.

. • to encourage farmers to retain sheep on farms where continued grazing by sheep was needed for environmental reasons.

. • to minimise the impact on the rural economy by providing sheep farmers with time to diversify their enterprises and develop alternative sources of income.

85. The Government would reach decisions on these issues in the light of the situation at the time. The views of stakeholders and in particular any relevant EU regulations which might be introduced, will be taken into account.

Glossary

ABPR EU Animal By-Products Regulation (EC) No. 1774/2002

APHIS Animal and Public Health Information System (Northern Ireland farm database)

BSE Bovine Spongiform Encephalopathy

CJD Creutzfeldt-Jakob Disease, a human transmissible spongiform encephalopathy

DAs Devolved Administrations

DARD Department of Agriculture and Rural Development (Northern Ireland)

DCS Disease Control System

DECC Disease Emergency Control Centre

Defra Department for the Environment, Food and Rural Affairs

DTI Department of Trade and Industry

EA Environment Agency

EC European Commission

EFSA European Food Safety Authority

EU European Union

FMD Foot and Mouth Disease

FSA Food Standards Agency

MAFF Ministry of Agriculture, Fisheries and Food

MBM Meat and bone meal. Animal-derived protein produced by rendering.

MHS Meat Hygiene Services: an executive agency of the FSA which enforces SRM and ABPR rules in fresh meat slaughterhouses and cutting premises.

NISP Northern Ireland Scrapie Plan NSP National Scrapie Plan ROD Regional Operations Director RPA Rural Payments Agency SAMU Scottish Animal Movement Unit SEAC Spongiform Encephalopathy Advisory Committee.

The Government’s main advisory committee on TSEs. SEPA Scottish Environment Protection Agency. SCOFCAH EU Standing Committee on the Food Chain and Animal Health

Scrapie A transmissible spongiform encephalopathy endemic in British sheep and found in many parts of the world. It is also found in goats.

SRM Specified risk material SSC Scientific Steering Committee STSE Sheep TSE Division, Defra SVS State Veterinary Service TSE Transmissible Spongiform Encephalopathy.

Disease of the neurological system. Spongy degeneration of the brain with progressive dementia. Examples in humans include CJD and kuru. Among animals: scrapie and BSE

Vetnet SVS holding, flock and herd database WFD Waste Framework Directive (Council Directive 75/442/EEC as amended).

Annex A

Table of responsibilities

Defra Defra Executive Agencies

Director General, Sustainable Farming, Food and Fisheries

Overall co-ordination of UK response. Chairman of Programme Board.

TSE Directorate (Sheep TSE Division)

Responsible for briefing, information, policy, liaison with internal and external interests on scientific aspects. Policy lead for genotyping (NSP).

TSE Directorate (BSE Division)

Responsible for the Animal By-Products Regulation.

Sustainable Agriculture and Livestock Products Directorate

Responsible for liaison with livestock industry/trade, impact on farmers, policy on recovery of sector, financial aid. Also responsible for the policy lead for slaughter and disposal scheme and briefing on nonscientific aspects.

Communications Directorate

Responsible for delivery of key messages to English stakeholders and media through press office, publicity, helpline, website and internal communications.

Environment Quality and Waste Directorate

Responsible for EU environmental legislation relating to waste management and disposal issues including the WFD, the Waste Incineration Directive and the Landfill Directive.

Procurement and Contracts Division

Responsible for the procurement of services and facilities for genotyping, disposal and other operational requirements in liaison with RPA.

DG Legal Services

Responsible for legal advice, drafting of necessary legislation for England and Wales.

Land Use and Rural Affairs Directorate

Responsible for the broader issues of impact on rural economy, of maintenance of grazing for environmental reasons in England.

State Veterinary Service

Responsible for logistical and field support, co-ordination of genotyping programme, general welfare issues, licensing and inspection of disposal premises under Animal By-Products Regulation.

Rural Payments Agency

Veterinary Medicines Directorate

Responsible for delivery of services at local level, contacts with farmers, logistics and administration of disposal scheme, financial aspects, helpline. Liaison with devolved administrations as necessary. Responsible for the recall of veterinary products, as necessary.

Devolved Administrations (Agriculture/Rural Affairs Departments)

. • Welsh Assembly Government

. • Scottish Executive

. • DARD

Others

Ministerial decisions on advice from SEAC and the FSA. Own command and control processes within an agreed framework, taking account of legislative and statutory responsibilities and local circumstances and institutional arrangements. Liaison with RPA for delivery of services, as necessary. Own co-ordinated communications plans.

Government Offices

Responsible for regional communication and feedback.

Food Standards Agency

Responsible for recommendations on measures necessary to protect public health based on advice from SEAC and EFSA. Also responsible for the removal of products from the food chain (through local authorities). Liaison with consumers/media, EU and other international bodies on public health aspects.

UK Health Departments

Ministerial decisions on SEAC/FSA recommendations. Responsible also for advice/action on medicine/medicinal products.

Department of Trade and Industry

Responsible for any action required on non-food consumer products.

Health and Safety Executive

Responsible for occupational health.

Meat Hygiene Service

An executive agency of the Food Standards Agency responsible enforcing any SRM controls and other controls in abattoirs.

Local Authorities

Responsible for the removal of food products from sale as directed by the FSA, other enforcement responsibilities, i.e. for animal welfare legislation.

SEAC

Responsible for TSE risk assessment.

Environment Agency (England & Wales)

Competent authority for the purpose of the WFD, for environmental protection including regulation of waste disposal activities, pollution prevention guidance and management of environmental consequences of the contingency plan.

Scottish Environment

Serving broadly the same function for Scotland as

Protection Agency

the Environment Agency.

Annex B

Partial regulatory impact assessment

1.Title

BSE in sheep contingency plan

2. Purpose and intended effect of measure

The objective

This contingency plan sets out the Government’s strategy for responding to a finding of naturally occurring BSE in sheep (including goats). Measures proposed in the plan are based on current advice from the relevant authorities. These measures aim to protect public health, to safeguard animal welfare, and to manage the impact on the sheep sector and the environment. Our aim is to enable the sector to recover and supply the food chain as quickly as practicable.

This plan would be activated on a UK basis – with detailed implementation by each administration. All UK consumers of sheep and goat products, and all UK keepers of sheep and goats are affected by this plan. Industries which use sheep and goat products are also affected.

Whilst the plan is about national measures it is likely that, in the event of BSE being confirmed in sheep, the EU would propose harmonised measures. Based on current information, and what the EU guidelines assume to be worst-case scenario, these are likely to be based on genotyping and age cut-offs.

The background

There is a theoretical risk of BSE being present in sheep. The Government recognises the need to plan for such a contingency (in the wake of the Phillips Inquiry on BSE in cattle). Moreover, the UK is required by the EU to have a contingency plan for the confirmation of BSE in small ruminants (and the EU have issued guidelines for this purpose).

This plan has been developed on the basis of current advice from the Food Standards Agency (and the Spongiform Encephalopathy Advisory Committee). It is also consistent with the EU guidelines, which are based on relevant advice from the European Food Safety Authority.

Risk assessment

BSE is a risk to human health. Both SEAC and FSA have considered this risk and the plan reflects their current recommendations. The plan also reflects the recommendations of the relevant EU authorities.

The scientific background to this plan is, however, evolving and developments on testing may alter the orientation of the plan. In particular, the on-going work to validate rapid tests, and therefore the negative results obtained to date using such tests, may trigger a fresh risk assessment by the relevant authorities. This could result in a lighter risk management strategy than proposed in this plan. It is not possible at present to say what this might be – but Option 1 below could cover such an eventuality.

3. Options

Option 1: Do nothing (no change to existing public protection measures, i.e. specified risk material controls).

Option 2: Allow into the food chain only (carcases of) animals which have tested negative for BSE.

Option 3: Allow into the food chain only ARR homozygous sheep without age restriction and ARR heterozygous sheep under 12 months of age (current SEAC/FSA recommendation).

Option 4: Allow into the food chain only ARR homozygous sheep under 18 months of age and ARR heterozygous sheep under 6 months of age (current EU Commission guidelines).

4. Benefits

Option 1: It is possible that this option would not meet the objective of protecting public health. It is not available based on the current positions of the relevant authorities. It would become available only if the risk is assessed to be sufficiently low, based on the calculated prevalence of BSE.

Option 2: This option would meet the objective of public health and be less disruptive to the livestock sector. However, it is not available at present because there is no validated test for BSE in sheep.

Option 3: This option would meet the objective of protecting public health as well as giving industry a means to resume its activities – as soon as genotyping and associated controls for progeny/flock certification/registration could be put in place.

Option 4: This is like option 3 but with age limits which are more restrictive for industry.

Equity and fairness

Options 3 and 4 are based on genotype. However, these options are not available to the goat sector as no goat genotypes have been found which make goats naturally resistant to scrapie (and as far as we know BSE).

Farmers with animals which have been tested under the National Scrapie Plan (NSP) or the Northern Ireland Scrapie Plan (NISP), in particular breeding rams, and found to be of the desired genotype would have the advantage that such animals should not have to be tested again.

5. Costs

Compliance costs

In general costs are being ascribed either to industry or to Government for the purpose of this RIA. However, some of these costs could in principle be shared. The GB Animal Health and Welfare Strategy has undertaken, under new initiative xiv to review cost-sharing for animal health across the board. New policies emerging from this work could impact the distribution of costs for implementing this plan.

Option 1: As already explained, this option may or may not be sufficient and would need to be supported by a risk assessment from SEAC which confirms the presence of BSE but recognises that the risk this poses to human health is acceptable. Compliance costs would be nil.

Option 2: The costs of this option to industry would almost exclusively fall on slaughterhouses. They would be responsible for sampling and ensuring a system was in place which didn’t allow untested or positive carcases into the food chain. This would involve holding carcases until the results are available from an approved laboratory and dealing with the consequences of any positive results. These administrative and capital costs cannot be estimated but will vary from slaughterhouse to slaughterhouse depending on throughput and existing facilities/administration. However these costs could be met either by Government or farmers or passed to others in the food chain, i.e. retailers or ultimately, consumers.

Option 3: This option would require the genotyping of all UK rams (except those already tested under the NSP or NISP) and the disposal of those of an unsuitable genotype. It is estimated (as of January 2004) that some 10% of rams in the UK breeding population of 450,000 have been tested and are of the desired genotype. There are considerable variations in how this figure of 10% is distributed across breeds, as some breeds are naturally more resistant than others. There are up to 15 known genotypes in sheep, with the prevalence of each genotype varying from breed to breed. It is not possible to go into this level of detail in this partial RIA.

Depending on the time of year when it had to be implemented this option could, on a worst-case basis, require the disposal of a single lamb crop, and any animals left from the previous year’s crop. This is assuming that progeny/flock certification/registration arrangements could be introduced for the following breeding season. Cull ewes would no longer be allowed into the food chain (as it would not be cost-effective to genotype them). It would take some time to restore the national ram flock to current levels and not all ewes would be mated, unless fully resistant rams could be imported.

Most of the costs to farmers will actually be in the form of reductions in income rather than additional financial burdens, i.e. from lost sales. These losses would reduce over time, as more lambs were able to go into the food chain. In general, cull ewes would not go into the food chain.

There will be some areas where businesses will find themselves exposed to additional costs. Due to the initial scarcity of rams of the desired genotype the price of these animals, or their use, is likely to be high (though this would benefit owners and breeders of such animals).

The initial slaughter of lambs and cull ewes as well as rams which are of an unsuitable genotype will have to be phased to match available disposal (slaughter/rendering/incineration) capacity. These animals will need to be kept on farms, in compliance with welfare regulations, until disposal. This will mean that farmers will incur costs in feeding, housing and other husbandry costs – but they may receive financial aid for this.

There are also likely to be additional costs in the management of flocks, which will need to be certified/registered, and more comprehensive records will need to be maintained. This would be the means to ensure that animals which go into the food chain were of the correct genotype and age. At slaughterhouses (after the initial cull) there will be additional costs for checking genotype certification and age limits. Costs for age limit checks will depend on whether FSA/SEAC accept dentition checks as a reliable method or whether they want to see some other more reliable form of identification and age verification. The sheep sector is already improving in this area and it is too early to say how much additional cost would be involved. Again, some, if not all, of these ‘assurance-related’ costs could be passed to others in the food chain.

Option 4: The costs would be very similar to those involved for option 3, with the added drawback that about 40% fewer animals could go into the food chain. There would also be an additional cost to dispose of lambs over 6 months of age. This is highly likely as a number of slow-maturing breeds (predominantly for hill farming) would be unlikely to be ready for slaughter before 6 months – though some might, and therefore these animals would continue to be bred for food and for grazing land.

Other costs

Options 2, 3 and 4 have considerable cost implications for Government.

Option 2 If it ever become possible to test animals in this way the availability of sufficient laboratory capacity could become an issue. However, this is not being explored given that there is no test available.

The costs of this option to Government would consist primarily of the costs of testing carcases for BSE. It is assumed that Government would bear this cost – although in principle it could be shared with industry. We estimate about 20 million animals –

16.5 million lambs and 3.5 million cull ewes will need to be tested every year. Assuming an average cost of £27 per test, the total annual cost would be around £540 million. £27 is equivalent to 40 Euros which is the maximum amount allowed under EU state aid rules for cattle BSE tests. If the same limit was applied for sheep BSE tests, any costs in excess of £27 would have to be met by industry/retailers/consumers.

In addition there would be costs associated with the disposal of animals which test positive. We assume that 1 in 10,000 animals will test positive. This figure is based on the number of negatives (100%) currently recorded from about 10,000 tests (albeit unvalidated tests). This ratio will improve over time as more negative tests are recorded. The estimated cost of disposal is about £1 million – including rendering, incineration, possible compensation, etc.

Option 3 The costs of this option to Government would consist of (one-off) genotyping, disposal of rams of the wrong genotype and of a season’s lamb crop; and (recurring annually) the disposal of cull ewes. The cost of genotyping rams not already genotyped under the NSP, is estimated at £8 million (400,000 animals at £20/animal). There would be a consequent cost of disposing of rams of the wrong genotype. If we assume the current ratio of genotypes in the NSP is indicative of the national flock we can project that 27% of rams will be fully resistant, 40% semi-resistant and 33% non-resistant. These percentages are average figures which do not reflect variations for individual breeds. Some of the semi-resistant rams could be retained for breeding to increase the supply of fully resistant rams. The others could be disposed, with the non-resistant rams. The cost of disposing of these rams, about 250,000 animals in total is estimated at about £4 million – slaughter, rendering, incineration, etc.

It is assumed that there will be an entire UK lamb crop – 16.5 million animals – that could potentially have to be disposed of. Actual numbers will depend on the time of year when the presence of BSE were confirmed but it can be assumed that an entire crop will have to be disposed as their genetic status will be uncertain because they would not have been produced under certified/registered flock/progeny conditions. The cost of disposing of these animals is estimated at £250 million (i.e. at about £15/animal).

In principle it might be possible to genotype some of these lambs – provided the capacity were available. Maximum genotyping capacity could be expanded to an estimated million animals a year. This capacity will be used as a matter of priority to rams and ewes for breeding. This would suggest that at most we could genotype around 500,000 lambs – and of these we can assume about 33% will be nonresistant and will have to be disposed of.

Under option 3 there would also be an annual cost of £52 million for disposing of cull ewes – about 3.5 million animals, some 20% of the national flock, at £15 per animal.

The other very significant cost for Government would be the cost of any compensation that was paid to farmers for the value of their animals which had to be disposed of and which could not go into the food chain. The proxy value of 250,000 rams and 16.5 million lambs is estimated at £532 million (at £150/ram and £30/lamb). Added to this there would be the value of the 3.5 million cull ewes – £122.5 million at £35/ewe. These values are approximate and average values, used for illustrative purposes.

There may be other costs for Government such as any retention aid paid to farmers to encourage them to keep their animals to an appropriate welfare standard until they can be disposed of, or to graze land for environmental reasons.

The full cost of the Government package cannot be determined until Ministers have decided on the financial support that they will offer to industry.

Option 4 Potentially there could be costs incurred by all other parties in the sheep chain including feed suppliers, suppliers of veterinary products, auction markets, slaughterhouses, processors, retailers, etc. It is not possible to estimate what these costs might be and also to what extent they will be passed to others in the chain, down to consumers.

Costs for a typical business

It is not possible at this stage to carry out any analysis of the likely costs for a typical business for a number of reasons.

Firstly there is inherent variability in the costs which could be associated with the various control options. Also, the effect of any additional costs will be influenced to a large extent by the levels of compensation and other assistance which would be offered by Government. We would also need to take into account the extent to which farmers and others affected by the introduction of controls (mainly those in the slaughter and processing industry) can pass on any additional costs to others in the food chain such as retailers and ultimately consumers.

Costs for individual businesses will also depend on the current status of their flocks and whether they are recognised, through the National Scrapie Plan, or Northern Ireland Scrapie Plan as flocks which comprise ARR homozygous rams and ewes (level 1) and flocks where the progeny have been exclusively sired by ARR homozygous rams (level 2).

The variability in genetic make up between different breeds also means that farmers who manage flocks of different breed types will have significantly different costs associated with any controls. For example, using NSP test results as a guide, if a business was using Suffolk rams there is a 58% chance that its rams are of the most resistant genotype. But a business based on Welsh mountain rams has only a 16% chance of its rams being of this type. This is complicated by the fact that different breeds are not always interchangeable and many are bred for specific environments (particularly upland breeds).

Businesses producing sheep and goat products for non-food use, e.g. leather, pet food, sheep wool and goat hair may also be affected. A study is being carried out into the non-food use of sheep and goat products and this draft RIA will be updated to reflect its findings.

6. Consultation with small business

The implementation of measures in this contingency plan will not disproportionately affect small businesses. Most farms are small businesses, but all businesses will be affected by this plan whether small or large. Size will not generally be a determinant of impact on business although smaller farm are less likely to be diverse than larger farms and therefore less able to find alternative income streams. Other factors will be more important, i.e the breed of sheep on the farm and the extent to which the animals on that farm had already been tested under the NSP/NISP. It is not clear, given the public health imperative, whether special provisions can be made for small businesses but this could be explored in the consultation exercise.

7. Competition assessment

The competition filter test questions relating to market share (Q1-3) are not applicable to the sheep/goats sector. There will however be differential impacts (Q4) depending on the genotype of animals (and also the level of penetration of voluntary NSP/NISP testing). Any impact on market structure (Q5) is likely to be short-term. The issues of higher set-up or ongoing costs for new businesses compared to existing ones (Q6-7), or of technological change (Q8), do not arise. Business choices (Q9) would be affected, but all businesses would potentially be in the same position and restrictions would be justified for public health reasons.

8. Enforcement and sanctions

In the main the legal powers to implement/enforce this plan already exist in England and Wales. These are being sought in Scotland and Northern Ireland, but if required emergency powers would be introduced there.

If implemented the plan will require effective enforcement to protect public health and safeguard the industry’s reputation. There are three main areas across all four options which could give rise to enforcement action:

Food chain – It will be an offence for sheep meat of the incorrect age/genotype to enter the food chain. This will be enforced at a number of points and by a number of enforcement bodies, e.g. slaughterhouses (MHS), Processors (LAs), Retails (LAs).

Genotyping – When measures are brought in it will be an offence to breed from a ram of the wrong genotype, to not have rams genotyped etc. These measures will be enforced by SVS inspection.

Certification – A range of measures will be put in place to certify genotypes and ages of sheep. Farmers and others who do not abide by these measures will be subject to enforcement action.

9. Monitoring and review

The contingency plan will be subject to regular review to reflect any changes in science or policy.

10. Consultation

Government

In the production of this plan we have consulted with the following Government departments: Department of Health Department of Trade and Industry Cabinet Office Food Standards Agency Scottish Executive Welsh Assembly Government Department of Agriculture and Rural Development in Northern Ireland

Public

This plan will be subject to a 12-week public consultation.

11. Summary and recommendation

The report of the BSE Inquiry in October 2000 criticised Government for failing to prepare for the link between a new variant of CJD and BSE. In its response to the Inquiry in September 2001, the Government recognised the importance of effective contingency planning and accepted responsibility for ensuring an appropriate level of preparedness to protect public health. This contingency plan is an essential element of that preparedness, for the possibility of BSE in sheep, and meets an EU requirement. The measures set out in this contingency plan are based on current advice from FSA/SEAC for the protection of public health. In addition these measures are the most effective, under present circumstances, to ensure that industry can recover as quickly and as safely as practicable. The plan will be updated at regular intervals but we now need a formal consultation exercise to inform the work on the detailed operational plans.

Contact point

Patrice Mongelard Livestock Strategy Division Area 5A 9 Millbank c/o 17 Smith Square London SW1P 3JR Telephone: 020 7238 3068 Fax: 020 7238 3082 Email patrice.mongelard@defra.gsi.gov.uk