Consultation Document
Implementation of New EU-Wide Controls on Scrapie-Affected Farm
1. Summary
1.1 Scrapie is a fatal brain disease of sheep and goats. It is a spongiform encephalopathy disease (others include bovine BSE and human CJD). It has been a notifiable disease in the EU since 1993.
1.2 Last year new EU measures were agreed which require extensive disease control action on farms with a case of scrapie confirmed from 1 October 2003 (EC Regulation 2003/260). Following changes to the Regulation in September 2003 this consultation seeks your views on proposals to enforce these controls. Subject to consideration of the views from this consultation they will be enforced from early in 2004.
1.3 Scrapie eradication via breeding for scrapie resistance is possible for sheep because each sheep has a unique resistance or susceptibility to scrapie, which can be determined through a scrapie 'genotyping' test on DNA from a blood sample. The more resistant sheep can then be preferentially used for breeding to pass on their resistance through their progeny. This is the basis of the current voluntary National Scrapie Plan for Great Britain (NSP) 1. A programme of selective breeding is not however an approach that can be adopted for goats which are not known to possess genes that confer resistance to scrapie.
1.4 The controls in the EC Regulation described in this consultation will provide for either whole flock/herd slaughter of the sheep and goats from a farm on which scrapie is confirmed. Alternatively, a sheep flock may be genotyped and certain susceptible genotypes of sheep in the flock disposed of. The EC Regulation specifies restrictions on what genotypes of animals can be brought onto, and moved from, the scrapie affected farm after initial culling and the period over which these restrictions will apply. Only sheep of the more scrapie resistant genotypes will be permitted to go into the food chain from farms subject to the controls. Other susceptible sheep, and goats, will be slaughtered and their carcasses disposed of.
1.5 Derogations from the culling of the susceptible sheep can be given where there may be difficulty in sourcing replacement animals of desired genotypes, where the frequency of resistant genes within the breed or flock is low, or if necessary to avoid inbreeding. We have set out how we propose to apply these derogations.
1.6 Compensation will be paid for culled animals that cannot go into the food chain and for embryos and ova that are destroyed. Although not required by the EU Regulation, we propose to assist farmers with replacing culled breeding rams with those of the most scrapie resistant genotype, and with some genotype testing of replacement animals. A table describing the different scrapie genotypes in sheep and how they will be treated under these controls is at Annex A.
1.7 We invite you to comment on specific elements of our proposals where we have national discretion on the controls to be applied.
2 Background
2.1 Scrapie can be transmitted within and between flocks. It is important to take effective action to eradicate scrapie from farms where it is known to occur. Such action is part of our extensive controls to protect against the acknowledged theoretical risk that other TSEs were they to be present in and maintained in the sheep or goat population could be masked by scrapie (for example the clinical signs of experimental BSE in sheep can be indistinguishable from those of scrapie). Although some sheep may have been exposed to BSE infected feed before the ban on the recycling of ruminant protein in ruminant feed in 1988 it is important to stress that BSE has not been detected in the sheep. In the meantime however scrapie continues to affect many farms in the EU.
2.2 In recent years in Great Britain 2, on average 167 flocks per annum had confirmed cases 3. Typically they average about 500 or so animals (but numbers can vary widely). About half these flocks reported single cases (although some have been affected by a persistent problem) and about half of the flocks have had cases before.
2.3 The total number of reported cases was about 600 per annum (prior to the Foot & Mouth Disease outbreak of 2001). We also know from a large scale anonymous survey of sheep farmers conducted in 1998 that only about 1 in 8 farmers report suspicions of scrapie. Scrapie can often reoccur within a flock with most cases occurring in animals between 2-5 years of age. The risk of this happening can be substantially reduced by a) using scrapie resistant rams and b) identifying and culling scrapie susceptible animals on affected farms and replacing them with more resistant ones.
2.4 In April 2002, the European Commission's Scientific Steering Committee published an Opinion that recommended that where a case of scrapie is confirmed in a small ruminant farm the flock/herd should be culled. However, it recognised that culling sheep of the most scrapie resistant genotype (ARR/ARR) would carry little risk reducing benefit. Subsequently, the Commission proposed compulsory EU wide measures, which were adopted in Regulation 260/2003 amending the TSE Regulation 999/2001. Following representations from the UK and some other Member States amendments to the Regulation, which introduced some flexibility to the controls, were agreed in September 2003.
2.5 Government is also planning a voluntary Scrapie Flock Scheme, as part of the NSP, which will be open to historically affected flocks - those that have had a case confirmed between July 1998 and the enforcement of the EC Regulation. It will be similar to but less onerous in some respects than the EU Regulation (Scottish Executive press release SEEN 638/2003).
3 Scheme features
The following will be the key features of the proposed EU (compulsory) Scrapie Flocks Scheme. The features are mainly as specified in the EU Regulation but there are some features where we have national discretion.
We welcome your views specifically on these aspects.
Scope
3.1 The EU compulsory Scrapie Flock Scheme will apply in the case of confirmation of TSE in a sheep or goat from the date of enforcement of the EU legislation (expected to be in early 2004). It will not apply retrospectively.
3.2 Farms which have flocks participating in the planned voluntary NSP scheme for historically affected flocks, that have a further case of scrapie confirmed after the date of enforcement of the EC Regulation will be subject to its provisions.
3.3 Research flocks will be able to apply for exemption from these measures. Guidelines are being drawn up to cover the exemptions. They will be circulated to research establishments for comment.
3.4 As happens now, where a sheep or goat is reported as showing clinical signs of a scrapie-like disease, there will be a prompt veterinary assessment of the suspect animal by the State Veterinary Service. If suspicion of scrapie cannot be ruled out the animal will be compulsorily slaughtered and post mortem laboratory investigations carried out to confirm the presence or otherwise of the disease. Compensation is paid for the culled animal.
3.5 Under the new controls, if scrapie is confirmed there will be a veterinary inquiry to identify all the small ruminants on the farm, including, if they can be identified, the parents, last progeny, embryos and ova of the animal in which the disease was confirmed. As these animals and materials present a risk of transmission it is appropriate, where practicable, to require their destruction.
Disease control options
3.6 In the case of confirmation of scrapie on a farm, the EU Regulation imposes movement restrictions on the sheep and goats on the farm and requires the competent authority (the SVS working on behalf of the Scottish Minister) to take action to eradicate scrapie from the farm by either:
(1) Whole Flock/Herd Slaughter
Killing and complete destruction of all the sheep and goats, embryos and ova on the farm, or,
(2) Whole Flock Genotyping
Killing and destruction of sheep and goats, embryos and ova on the farm except ARR/ARR genotype breeding rams, breeding ewes carrying at least one ARR allele and no VRQ allele in their genotype, and sheep carrying at least one ARR allele in their genotype intended for slaughter.
3.7 Under option (2) above _ the genotyping approach - the general rule will be that all sheep on the farm would be genotyped. Genotyped sheep will also be identified electronically, by means of a ruminal bolus as with currently NSP genotyped sheep, or in future other accepted Electronic Identification devices (EID). This will ensure a secure association between the sheep and its genotype test result. Genotype certificates will be issued for ARR/ARR sheep (the most resistant genotype) which will not be subject to restrictions.
3.8 In certain circumstances, the option of a derogation from culling may also be available. (see paragraphs 3.25-3.27 below).
3.9 If the infected animal was introduced from another farm, and based on the history of the case may be applied on the farm of origin in addition to, or instead of, the farm at which the infection was confirmed. In the case of land used for common grazing by more than one flock, it may be decided to limit the application of measures to a single flock, based on a consideration of all the epidemiological factors. (Consideration is also being given to whether this distinction possible on common grazing could also be applied to a farm where certain flocks /herds may be isolated from other flocks /herds).
3.10 It is envisaged that the course of action taken will need to be varied depending on the circumstances, advice from veterinary experts, and with regard to the views of the owners of the animals.
3.11 In some cases, whole flock slaughter may be appropriate such as in a flock with little or no resistant genes and where there is no realistic prospect of achieving the desired genetic profile of resistance conferring genotypes, for example where most of the sheep are replaced frequently or where the flock does not breed its own replacements.
3.12 In other cases the genotyping approach may well be appropriate. Farmers would be given veterinary advice on the genotype status of their flock and full account taken of their views. Cost may be a factor in determining the option to follow. An appeals process to allow an owner to have the decision reviewed would be established. However the final decision would rest with Government. We are drawing up guidelines to be followed when deciding on a course of action.
Your views are welcomed on this proposed approach and on any other factors that should be considered.
Disposal of 'susceptible' animals on a farm while it is subject to the controls
3.13 Once animals for disposal are identified under either of the options at paragraph 3.6, they may need to be visibly identified to assist in their subsequent removal. Contractors will be used to carry out the collection and destruction of these animals at specific premises. This will be at Government expense.
3.14 Where the number of animals to be disposed of is small, and if the farmer requests it, and if it is deemed preferable on animal welfare grounds (e.g. with regard to transport or other welfare concerns such as concurrent outbreak of lameness etc) supervised slaughter may be permitted on the farm.
Restrictions
(A) Restocking restrictions
3.15 After initial genotyping/culling action has been taken on a farm, restocking restrictions will apply for a period of three years from:
- the date when all sheep on the holding are of the most resistant ARR/ARR genotype;
- the last date when any sheep or goats were kept on the premises;
- the date when all breeding rams on the holding are of the most resistant ARR/ARR genotype and all breeding ewes carry at least one (resistance conferring) ARR allele, provided that scrapie testing of the brains of all culled and dead-on-farm sheep over the age of 18 months is carried out during this period with negative results; or
- the date when intensified TSE monitoring commenced in the case of goats.
It will be the responsibility of the flock owner to comply with these restrictions. We expect that TSE testing (under the 3 rd indent) have still to be considered. It may be necessary for some animals, subject to testing, to be sent to certain slaughterhouses in which case some of the costs may need to be borne by farmers.
Rams
3.16 In order to make progress as rapidly as possible in improving the scrapie resistance of the flock(s) on an affected farm, the EC Regulation requires that only ARR/ARR genotype males will be used as stock rams on the farm. Therefore, following initial genotyping or whole flock slaughter, only rams with the ARR/ARR genotype can be brought onto the farm while it is subject to controls. Stock rams of other less resistant genotypes will have to be culled as soon as practicable. They can either be culled and go into the food chain or be culled and destroyed at Government expense, depending on their genotype. Replacement rams must therefore be of the ARR/ARR genotype. There is provision for a derogation from this requirement in certain circumstances (see paragraph 3.25 below).
3.17 The advantage of this requirement is that, once the flock owner has been able to ensure that all of the stock rams on an affected farm are of this most resistant genotype, all of the progeny they sire should have at least one copy of the ARR allele in their genotype and so if desired can go (directly) for slaughter for consumption.
Ewes
3.18 Because the significant proportion of the sheep on a farm will be females imposing the same genotype/breeding restrictions as for stock rams on them may be impractical. The EC Regulation requires that following initial genotyping or whole flock slaughter, any female sheep introduced to the farm - for breeding- must have a genotype that contains at least 1 ARR allele (which confers resistance), and does not contain a VRQ allele (associated with susceptibility).
B) Restrictions on animals that can be sent off the farm
3.19 There is no restriction on the movement or use of ARR/ARR sheep. They can be moved from the farm or sold for breeding or for slaughter.
3.20 Sheep which carry only one ARR allele may be moved from the farm only to go directly for slaughter for human consumption or for the purposes of destruction.
3.21 However ewes with one ARR allele and no VRQ allele may be moved to other farms which are subject to the same controls under the Regulation. Sheep of any other genotype can only be moved from the farm for the purposes of destruction.
3.22 There will of course be a certain number of sheep on the farm that would not in any case be used for breeding, regardless of their genotype. The requirement described at 3.20 above would apply to these animals in order for them to go for slaughter for consumption. Otherwise they would be slaughtered and destroyed.
C) Embryos and Semen
3.23 There are also restrictions on sheep germplasm products that may be used following scrapie eradication measures. Semen has to be from a ram of the ARR/ARR genotype and embryos have to carry at least one ARR allele and no VRQ allele in their genotype.
Derogations
3.24 The EC Regulation allows Member States to apply certain derogations. We do not propose to apply the derogation to allow non-pregnant ewe lambs of an unknown genotype to be brought onto affected farms where it is difficult to obtain replacement ewes with at least one ARR allele and no VRQ allele. This would risk re-establishing infection onto a farm and there would be uncertainty about the genotype of progeny.
3.25 We do propose to apply where appropriate the other derogations provided for in the Regulation i.e. if the frequency of the ARR allele within a breed or farm is low, or where it is necessary to avoid inbreeding. This involves either:
(1) a delay in culling - for up to three breeding years,
or,
(2) animals other than those of the genotypes required in the Regulation may be introduced to the farm - provided they do not carry the VRQ allele.
3.26 A farmer will be able to apply for a derogation if it is established that the flock(s) was/were eligible (paragraph 3.25). Guidelines will be drawn up setting out the basic factors to determine eligibility of flocks _ these might be for example, the level of resistance in the breed, levels of resistance in the flock, size/rarity of the breed etc. A farm(er) granted a derogation will be subject to the restrictions on restocking where appropriate and movement of animals off the holding (paragraphs 3.15-3.18 above).
Your views on these criteria and any additional criteria would be welcomed .
3.27 The use of derogations will involve increased cost as during the period of derogation there will need to be additional genotyping of progeny. For example if the rams carry ARR as well as other alleles in their genotype it will not be possible to determine which of their progeny are eligible for the food chain without genotyping them. It may be appropriate that this extra cost is shared between the farmer and the Government and a suitable mechanism may need to be established in these circumstances. See also paragraph 3.36 below.
Your comments on a suitable cost sharing mechanism would be appreciated.
Policing
3.28 Once the measures set out in the Regulation are applied on a farm it will be the responsibility of the farmer to ensure that any progeny then bred on and remaining on the farm or any animal brought on to the farm is of a permitted genotype. Similarly, it will be the farmer's responsibility to ensure that any animals that leave the farm meet the requirements set out in the Regulation. Compliance will be monitored through spot checks.
Goats
3.29 Although scrapie in goats appears to be very rare the EC Regulations also affect goats on an affected farm.
3.30 Genotyping and selective breeding for scrapie resistance with goats is not possible as they are not known to carry any alleles associated with scrapie resistance. Therefore, where a farm which has a case of scrapie confirmed contains goats as well as sheep, the goats will be culled and destroyed with compensation paid as set out below (paragraphs 3.32-3).
3.31 After the initial culling of susceptible sheep and goats has been carried out on the farm, goats may be re-introduced to the farm after a thorough cleansing and disinfection of all animal housing on the farm following de-stocking provided that any breeding rams on the farm are of the ARR/ARR genotype and breeding ewes carry at least one ARR allele and no VRQ allele. The farm would be subject to scrapie testing of the brains of all culled or fallen goats over the age of 18 months for three years. It is expected that that testing would be arranged by Government although precise arrangements have still to be considered.
Compensation payments for culled susceptible sheep and goats, embryos and ova
3.32 As required by EC TSE regulation (999/2001), compensation will be paid for animals and any products of animal origin destroyed. In line with the rationalisation of compensation arrangements which were issued for consultation on 27 October 2003 (see paragraph 3.34 below). It is envisaged that rates consistent with current average commercial prices should be used. The proposed rates of compensation are:
- 90 for culled susceptible breeding sheep/goats
This figure equates to the rate currently payable for a confirmed scrapie case as laid down in the TSE (Scotland) Regulations 2002. It is suggested that a breeding sheep should be an animal where permanent incisor teeth have erupted through the gum.
- 50 for culled susceptible lambs/kids
It is suggested that a lamb is a sheep where permanent incisor teeth have not erupted through the gum.
- 30 for cull females
It is suggested that a cull female is one that would be culled in that year by the farmer in the normal course of business.
- 150 for embryos
It is accepted that the value of embryos may vary according to the parent stock. There may be a case for higher compensation for embryos of high value animals. These cases may be assessed on their merits, provided suitable documentation is available. As frozen embryos only have a 50-60% success rate it is suggested that the compensation paid should reflect this.
- Up to 5 for ova
Compensation up to this amount may be paid for ova if it can be shown that there is a market value for them.
High value animals
3.33 In addition, where farmers consider their animals to be of high value e.g. pedigree animals, they would have the opportunity to obtain a valuation to help establish compensation. They would be responsible for arranging the valuation, agreeing the valuer to be used with us and paying for the valuation. We would also require the farmer to provide some other supporting/recent evidence such as bill of sale, so that we could ensure the valuation was reasonable. We would make a decision on compensation to be paid based on the valuation and the other evidence provided. The farmer would be able to appeal against the decision.
Your views on this approach and the standard rates proposed above are welcomed
Compensation payments - review
3.34 The rates described above would apply from the outset of the application of these controls. However, in due course, compensation for measures concerned with scrapie control and eradication will need to be considered in the context of Government's broader policy on compensation for all animal diseases. Government is currently undertaking a separate consultation on proposed measures to rationalise the overall approach to compensation for all notifiable animal diseases, with the overall aim of simplifying the entire mechanism, and increasing the transparency of setting compensation rates. The above rates will be reviewed in the light of the outcome of that consultation and other relevant factors.
Assistance with the cost of replacing culled stock rams with rams of the ARR/ARR genotype .
3.35 The requirement as described above will be to use only ARR/ARR genotype rams, i.e. the most scrapie resistant. Rams of this genotype are achieving higher market prices at this years' ram sales. Until the NSP and any other genotyping initiatives have resulted in a general increase in the numbers of ARR/ARR rams in the national flock in some breeds these rams may be in short supply.
3.36 Although it is not required by the EC Regulation, we propose to provide assistance of up to 500 to assist farmers in being able to purchase replacement breeding rams of this genotype only, which they will be obliged to use. For rams purchased with this assistance, there will be no cumulation with the compensation rate mentioned at paragraph 3.32 above i.e. where a susceptible ram is culled and replaced with an ARR/ARR resistant ram the farmer will receive the proposed 90 compensation and up to 410 to assist with the cost of replacing the animal. This payment of up to 500 will not be available for any other stock ram genotypes. The rate proposed is the same as that envisaged for the Voluntary Scrapie Flock scheme (Scottish Executive press release SEEN 638/2003).). Where, as a result of derogations agreed, Government incurs expenditure in genotyping of progeny (see paragraph 3.27) it is envisaged that the payment for replacement rams would be up to 250.
We would welcome your views on this proposal.
Assistance with genotyping of replacement animals
3.37 Again, although not required by the EC Regulation, it is considered appropriate to provide some limited assistance with free genotyping to help identify replacement animals, of the permitted genotypes, (before purchase). This could be a large burden on the NSP budget. We may therefore have to restrict this to a maximum of two genotype tests per breeding animal to be culled and replaced.
We would welcome your views on this proposal.
4 The Statutory Instrument
4.1 A draft Statutory Instrument is at Annex C. It sets out provisions for the enforcement of the EC Regulation, movement of animals and compensation as well as the appeals procedure. This would involve representations to an independent assessor. Consideration would need to be given to how the expenses incurred by the independent assessor should be met, including in the light of any developments under the TSE regulations.
Your comments are welcomed on this draft.
5 Impact upon affected farms
5.1 The Scheme planned to implement the EC Regulation will be a compulsory requirement on scrapie-affected farms. A partial Regulatory Impact Assessment on the implementation of the Regulation is at Annex D.
Your views are welcomed on this assessment, particularly where requested in the text.
6 Scope of this consultation
6.1 This consultation is directed at interested parties in Scotland. Parallel consultations are being conducted by DEFRA on behalf of England, ARAD in Wales, and DARD in Northern Ireland. Comments from all interested parties are welcome particularly sheep and goat breeders/producers, their representative bodies and consumer interests.
7 Implementation
7.1 The EC Regulation came into effect on 1 st October 2003. Subject to the consideration of responses to this consultation, we are aiming to have the statutory instrument coming into force.
7.2 During the interim period between October 2003 and then any farmer who has a confirmed case of scrapie on his/her farm will be assisted in complying with the EC Regulation on a voluntary basis. If the farmer is not able to comply with the EU Regulation, he/she will be able to join the current NSP ram genotyping scheme under which he could have his whole flock genotyped in return for complying with a controlled breeding programme.
8 Timetable for this consultation
8.1 We are allowing a period of 6 weeks for this consultation. Although this is shorter than the standard period usually allowed for consultations, these proposals are in the main similar to those of the voluntary scheme for historically affected flocks (paragraph 2.5) which was the subject of an earlier consultation exercise. They have also been discussed on a number of occasions with industry and other members of the Government's Sheep and Goats TSEs Stakeholder Group.
8.2 We will respond as sympathetically as possible to requests for individual extensions to this consultation deadline.
9 Issues for comment
9.1 We would be grateful for your views on the issues raised in the document specifically:
- The proposal to use whole flock slaughter or genotyping depending on the circumstances (paragraphs 3.6-12)
- The criteria for application of derogations (paragraphs 3.24-6)
- Meeting extra costs involved in use of derogations (paragraph 3.27 and 3.36)
- Compensation payments for culled susceptible sheep and goats, embryos and ova (paragraph 3.32-3).
- Assistance with the cost of replacing susceptible breeding rams with ones of the ARR/ARR genotype (paragraph 3.36).
- Limited assistance with genotyping of replacement stock (paragraph 3.37).
- The Statutory Instrument and appeals procedure described therein ( Annex C)
- The draft Regulatory Impact Assessment ( Annex D)