REGULATORY APPRAISAL ANIMAL HEALTH, WALES THE TRANSMISSIBLE SPONGIFORM ENCEPHALOPATHIES (WALES) REGULATIONS 2006 Purpose and intended effect of the measure 1. The intended effect of the Instrument, which applies in relation to Wales, is to revoke and remake with amendments the TSE (Wales) Regulations 2002, which enforced Regulation (EC) No. 999/2001 of the European Parliament and of the Council laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies. 2. In response to the introduction of the Community TSE Regulations (Regulation (EC) 999/2001) and to consolidate Welsh legislation enacted in response to the BSE epidemic in Wales and the UK, the Welsh Assembly Government enacted the TSE (Wales) Regulations in 2002. Parallel legislation was also introduced in England, Scotland and Northern Ireland. 3. Regulation (EC) No. 999/2001 provides a framework for the prevention, control and eradication of certain transmissible spongiform encephalopathies (TSEs). TSEs are diseases of the brain and nervous system that gradually destroy brain tissues, resulting in a characteristic ‘sponge-like’ appearance. Examples include scrapie in sheep, Bovine Spongiform Encephalopathy (BSE) in cattle and Creutzfeldt-Jakob Disease (CJD) in humans. The TSE (Wales) Regulations provide the necessary domestic powers to enforce and administer our obligations under the European legislation. 4. Since March 2002, numerous amendments have been made to various articles and annexes in Regulation (EC) No. 999/2001. These amendments impact the procedures that are used in the feeding, slaughter, export and import, placing on the market, inspection and movement of cattle, sheep and goats. In response, a number of Statutory Instruments amending the TSE (Wales) Regulations 2002 have been made, namely: The Animal By-Products (Wales) Regulations 2003; The TSE (Wales) (Amendment) Regulations 2004; The TSE (Wales) (Amendment) Regulations 2005 and the TSE (Wales) (Amendment) (No.2) Regulations 2005. As a result a number of provision within the original Regulations have been revoked or replaced. However, some areas have not been addressed by these amendments and it has been decided that in order to prevent the existing Regulations from becoming more unwieldy by adding further amendments, they should be replaced in their entirety by new domestic TSE Regulations, which consolidate the current regulations and subsequent amendments. 1 5. These consolidation measures also incorporate the provisions of the TSE (Wales) (Amendment) (No 2) Regulations 2005, which sets out the criteria for abattoirs wishing to slaughter Over Thirty Month (OTM) bovine animals. 6. The Regulations will also introduce a rationalised compensation system for cattle slaughtered for BSE. Under this system compensation will be determined using table valuations, based on average market price for pre- determined cattle categories. There is also a provision for individual valuations to be used, at the discretion of the Minister should there be inadequate supporting sales data for a particular category in any particular month or months. 7. The Regulations also allow for some of the compensation rates for animals killed and destroyed under the Compulsory Scrapie Flocks Scheme to be adjusted. A table showing the revised compensation rates is attached at Annex 4. This proposed addition to the Regulation brings the rates in line with market values thus reducing the risk of possible abuse under the scheme. 8. The objectives of these Regulations are to:- • continue enforcement of our obligations under Regulation (EC) No. 999/200; • consolidate and update the existing Welsh legislation, reduce repetition of powers in the regulations, and address issues that have arisen since the TSE (Wales) Regulations 2002 (SI 2002 No. 1416 W.142) came into force; • address recommendations made by the Commission’s 2004 Food & Veterinary Office (FVO) Mission regarding feed controls, in particular registration and authorisation requirements for manufacturers using fishmeal; • introduce a rationalised compensation system for cattle slaughtered for BSE. (This proposed element of the legislation will have a later coming into force date of 25 May 2006) to coincide with the projected date for introduction of similar cattle compensation arrangements for Bovine TB, Brucellosis and Enzootic Bovine Leukosis; and • introduce changes to some of the compensation rates for animals killed and destroyed under the Compulsory Scrapie Flocks Scheme and new provisions for the arrangement of a valuation in exceptional circumstances to enable clear cases of overpayment to particular flocks to be addressed. Risk Assessment 9. Failure to update the TSE (Wales) Regulations to reflect the amendments to the enabling European legislation could potentially lead to infraction proceedings against the United Kingdom by the European Commission 2 and possible fines. There would also be problems enforcing the areas where references in the present regulations refer to specific points in the European legislation, which have been amended or removed. 10. Failure to consolidate the TSE (Wales) Regulations could lead to a lack of clarity in the Regulations and confusion as to the current requirements in force, which may have the effect of increasing non-compliance with the provisions of the regulations. 11. Failure to address the points raised by the 2004 Food and Veterinary Office (FVO) Mission, including those relating to the feed ban elements described above, could contribute to the European Commission delaying bringing forward a proposal to lift the beef export ban. Options 12. In respect of this legislation the “Do nothing option” is not an option as it would lead ultimately to infraction proceedings against the National Assembly for Wales by the European Commission. Option 2 - Make Guidance to enforce and administer TSE monitoring, control and eradication requirements. 13. Those involved in the agricultural industries affected by TSEs could, in theory, operate under guidance and a code of best practice developed either by industry or government in association with the veterinary profession and others. 14. In this area the use of voluntary codes of practice would not be advisable. The risk of contamination of herds and the subsequent potential increased danger to public health would not be justifiable. It is unlikely that a pure industry-run regulatory system would be feasible. Some Government enforcement and monitoring controls would be required, which could lead to a duplication of resources and inefficiencies in the monitoring regime. 15. If the scheme was regulated by industry itself there are difficult questions of impartiality and liability should standards decline. To address this, Government could intervene and monitor, but without punitive measures it would be arguable that even with Government surveillance there may be little impact on raising or maintaining standards. 16. EU member states, and other countries around the world, would be unlikely to accept a voluntary regime as sufficient safeguard against TSEs and therefore would regard Wales and the UK as high risk countries for BSE. Member states and third countries would then take the necessary measures to protect their own livestock, which is likely to include restricting imports from Wales and the UK. This would be punitive for the Welsh meat and connected industries. 17. The EU requires that member states receive frequent inspections to verify compliance with Regulation (EC) 999/2001. It is likely that the Commission will take the view that the UK Government would not be 3 meeting its obligations under the European Regulations with a voluntary regime. This could lead to infraction proceedings, which could lead to a substantial fine from the Commission for the UK. 18. Additionally, public confidence in the Assembly’s BSE controls could be significantly dented if there appeared to be an indirect relaxation in controls. Option 3 - Make the Legislation only to reflect the subsequent European amendments 19. Updating the Regulations for the amendments made to Regulation (EC) 999/2001, subsequent to the creation of the TSE (Wales) Regulations 2002, would ensure that the Welsh legislation is up to date in reflecting our obligations under the European TSE Regulations. 20. However, only updating the Regulations would not address such issues as the need to rationalise arrangements for appeals and would not cover changes required to Regulations to reflect changed industry working practices. An update, based solely on the European amendments, would also leave unresolved the areas of repetition of powers both within the document and with Welsh animal by-products legislation produced after the 2002 TSE Regulations. Option 4 –Make the Legislation 21. The preferred proposal is that the existing regulations are consolidated and updated to reflect the amendments to Regulation (EC) 999/2001 and current working practices in the monitoring and eradication of TSEs. 22. As the majority of the provisions are simply an update and consolidation of existing provisions, there should not have a significant economic impact on producers. However, there would be some areas in the updated Regulations where there is likely to be some impact on producers, these are outlined and their impact discussed in greater detail in the sections on benefits and costs. 23. Both updating and consolidating the Regulations will mean that the new Regulations will have the correct references to