Lena Björnerot. Bull. Eur. Ass. Fish Pathol., 22(2) 2002, 139

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1 Bull. Eur. Ass. Fish Pathol., 22(2) 2002, 139 Animal health and zoosanitary review of the Community legislation concerning aquatic animals and products - with special emphasis on criteria for future listing of fish diseases Lena Björnerot European Commission, Health & Consumer Protection Directorate-General, Directorate E - Food Safety: plant health, animal health and welfare, international questions, Unit E2 - Animal health and welfare, zootechnics Background This paper aims to summarise the current animal health Community legislation with regard to aquatic animals and products and to provide information on the preliminary discussions held with Community experts concerning the need to revise the legislation in this area. The information in the paper does not necessarily represent the view of the Commission. The first Community legislation concerning animal health in aquaculture production was adopted in Today, detailed and harmonised legislation is in place covering animal health aspects of aquaculture production. The legislation includes conditions governing the placing on the market of aquaculture animals and products, measures for the control of certain fish diseases 2 and of certain diseases affecting bivalve molluscs 3, sampling plans and diagnostic methods for the detection and confirmation of certain fish diseases 4 and of certain mollusc diseases 5. For certain diseases listed in the legislation, several decisions for approval of farms and zones have been taken which protects and enhances the trade between disease free areas. In addition, decisions have been adopted concerning movements of different aquatic animal species and products within and into the Community 6 and certain protective measures have been taken in respect of infectious salmon anaemia (ISA) in salmonids in Norway and Faroe Island 7. Since 1998, when ISA first was detected within the Community, decisions have been taken to adapt the legislation to new situations, increase in knowledge and to give provisions to the Member States for combating the disease in a relevant manner 8. Decisions have been adopted on withdrawal measures to be applied in the United Kingdom and Ireland in case of outbreaks of ISA 9. Furthermore, a Council Decision 10 has been adopted which, in combination with a Commission Regulation 11, establishes the conditions under which the Financial Instrument for Fisheries Guidance (FIFG) could provide for financial contribution for control measures taken in the case of outbreaks of ISA. Prior to granting a financial contribution, the Member State must present a disease control or eradication pro-

2 Bull. Eur. Ass. Fish Pathol., 22(2) 2002, 140 gramme, which must be approved by the commission. In addition to the regular updating of the legislation, an animal health and zoosanitary review of the Community legislation concerning aquatic animals and products has been initiated by unit E2 (Health & Consumer Protection Directorate) of the European Commission. It has been concluded that a revision is needed to take into account the developments in aquaculture production, as well as the practical and scientific experiences gained during the last ten years. In the review process, the Member States, including well-reputed animal health experts within the aquatic field and the industry are consulted. Major proposals for revision The Community aquatic animal health legislation should be simplified and made clearer and should be as consistent as possible with the International Aquatic Animal Health Code and the Diagnostic Manual for Aquatic Animal Diseases of the International Office for Epizooties (OIE). The diseases to be regulated at Community level need to be reviewed, as well as the susceptible species and vectors of concern. Future legislation should also consider the potential exchange of disease agents between farmed and wild aquatic animals and the regulations for fish should be separated from the ones for molluscs and crustaceans. Furthermore, it has been proposed that the legislation should be more flexible, giving provisions for urgent amendments in order to adapt the legislation to changed production and health conditions - including emerging diseases - and gained knowledge within the Member States and in other countries. Further proposals for major changes and the issues to be carefully reviewed are: the requirements for National and Community reference laboratories; sampling and diagnostic methods; introduction of a risk based program including preventative measures and monitoring of farms and other establishments; management routines for transport and waste; requirements and administrative procedures for approval of farms and zones, including criteria for zoning and movements of farmed animals and wild breeding stock; control measures to be applied in different situations; and provisions for financial support and vaccination. There is also an urgent need to lay down harmonised animal health conditions for imports of aquatic animals and products from third countries. Preliminary strategies for notification and listing of fish diseases in a future Community legislation Within the framework of the zoosanitary review of the Community aquatic legislation, certain criteria have been drafted as a basis for the evaluation of which aquatic diseases that are of such significance that they should be regulated in a future Community legislation. In addition, the guidelines of OIE and the animal health situation within and outside the Community have been taken into account. The diseases to be listed and regulated by the Community legislation should in particular include diseases notifiable to the OIE, as well as emerging diseases of significance, but might also - where relevant - include other disease defined by the OIE under Other significant diseases. A final conclusion as how best to group or list diseases at a Community level (e.g. what provisions and measures to be applied in relation to trade and control for

3 Bull. Eur. Ass. Fish Pathol., 22(2) 2002, 141 the different diseases) has not yet been reached. In the OIE International Aquatic Animal Health Code of 2001, the following definitions are given: Diseases notifiable to the OIE (previously known as List B diseases ) means the list of transmissible diseases that are considered to be of socio-economic and/or public health importance within countries and that are significant in the international trade in aquatic animals and aquatic animal products. Reports of these diseases are normally submitted once a year, although more frequent reporting may be necessary in some cases 12. The Aquatic Code also lists Other significant diseases which are defined as: diseases that are of current or potential international significance in aquaculture, but that have not been included in the list of diseases notifiable to the OIE because they are less important than the notifiable diseases, or because their geographical distribution is limited, or it is too wide for notification to be meaningful, or it is not yet sufficiently defined, or because the aetiology of the diseases is not well enough understood, or approved diagnostic methods are not available. According to the OIE, certification is generally required for diseases that are notifiable to the OIE, if it is relevant in the particular situation. In the OIE Code for mammals, birds and bees, the notifiable diseases are divided under two lists: list B, in principle corresponding to the notifiable diseases of the aquatic Code; and list A, defined as transmissible diseases which have the potential for very serious and rapid spread, irrespective of national borders, which are of serious socio-economic or public health consequence and which are of major importance in the international trade of animals and products. Reports are submitted to the OIE as often as necessary (as specified in the Code). It should be noted that the OIE listing and notification procedures currently are under revision. The detection of a list A disease within the Community initiates obligatory control measures. According to the OIE, the nature of the aquatic animal diseases and the volume of the aquatic animal trade is such that no aquatic diseases are presently categorised as list A diseases. However, it has been proposed, for future aquatic Community legislation, to keep provisions for a list I, corresponding to the present list I in Annex A of Directive 91/67/ EEC, to which obligatory measures shall apply in case of suspicion and confirmation. Only very serious diseases, exotic - or maybe rare - to the Community can be placed on this list. The aim is that the Community should be kept free of list I diseases and, if detected, measures shall be taken to eradicate the disease if possible. Furthermore, the Community legislation should give provisions for financial contributions - i.e. a percentage of the compensation given - to the Member States for measures taken. As mentioned, flexible legislation for safeguard measures to be taken in case of suspicion and confirmation of other exotic and of emerging diseases is essential. Another working theory is to merge the present list II and III of the said directive to a new list II including only diseases that at

4 Bull. Eur. Ass. Fish Pathol., 22(2) 2002, 142 least fulfils the criteria i) and/or vi) plus iii), iv) and v) as described below. The purpose of the list II would be containment, with the aim to either a) achieve a gradual eradication from EU or b) lay down provisions for achieving and maintaining freedom at a regional level. Application of the provisions for list II would require that a national control program, approved at Community level, is in place in the region concerned. Preliminary criteria - of which diseases to be covered by a future EU legislation shall meet a significant number: i) The disease causes, or has potential to cause significant losses at a regional level (annual costs associated with the disease and its control may exceed 5% of the value of the production of the susceptible fish species produced in the region). ii) There is a reliable and simple test for infected animals. The tests must be specific and sensitive and the testing method should be harmonised at EU level. iii) The disease is difficult to control and contain at farm level without stringent biosecurity measures. iv) Experience has shown that disease free zones can be established and maintained. v) Disease control at regional level is cost beneficial. vi) The disease has a detrimental impact on the wild fish populations and/or wild fish used for stock enhancement. Notification In principle, it has been proposed that diseases to be notifiable in future aquatic Community legislation should be those on a new list I and II, as well as exotic and emerging diseases of potential significance. Member States shall ensure that the suspected presence of any of these diseases is compulsorily and immediately notifiable to the competent authority. Confirmed cases - and also suspicions of epidemiological significance - of the notifiable diseases shall immediately be reported to all other Member States and to the Commission. However, suspicion and outbreaks of List II diseases in non approved zones or farms only have to be reported annually to the Member States and the Commission (but, of course, they still must be notified immediately to the Competent Authority). References 1 Council Directive 91/67/EEC (OJ L 46, , p. 1) as last amended by Directive 98/45/EC (OJ L 189, , p. 12) 2 Council Directive 93/53/EC (OJ L 175, , p. 23) as last amended by Commission Decision 2001/288/EC (OJ L 99, , p. 11) 3 Council Directive 95/70/EEC (OJ L 332, , p. 33) as amended by Commission Decision 2001/293/EC (OJL 100, , p. 30) 4 Commission Decision 2001/183/EC (OJ L 67, , p. 65) repealing Decision 92/532/ EEC 5 Commission Decision 94/306/EC (OJ L 133, , p. 51)

5 Bull. Eur. Ass. Fish Pathol., 22(2) 2002, As the Commission Decisions: 96/490/EC (OJ L 202, , p. 21) on certain protective measures with regard to Gyrodactylus salaris in salmonids, as amended by 98/24/ EC (OJ L 8, , p. 26); 93/22/EEC (OJ L 16, , p. 8) laying down the model of the movement documents referred to in Article 14 of Council Directive 91/67/EEC; 1999/ 567/EC (OJ L 216, , p. 13) laying down the model of the certificate referred to in Article 16(1) of Council Directive 91/67/ EEC; 93/55/EEC (OJ L 14, , p. 24) amending the guarantees for the introduction of molluscs into zones for which a programme for Bonamiae ostreae and Martelia refringens has been approved, as amended by 93/169/ EEC (OJ L 71, , p. 16), and 95/352/ EC (OJ L 204, , p. 13) laying down the animal health conditions and the certification requirements for the importation from third countries of Crassostrea gigas for relaying in Community waters. 7 Commission Decisions 1999/766/EC (OJ L 302, , p. 23), as last amended by 2002/109/EC (OJ L 40, , p. 12) and 2000/574/EC (OJ L 240, , p. 26), as amended by 2002/110/EC (OJ L 40, , p. 13). 8 Council Directive 2000/27/EC (OJ L 114, , p. 28), amending Directive 93/53/ EC 9 Commission Decision 2001/494/EC (OJ L 180, , p. 34) repealing Decision 2001/ 186/EC 10 Council Decision 2001/572/EC (OJ L 203, , p. 16) amending Council Decision 90/424/EEC of 26 June 1990 on expenditure in the veterinary field (OJ L 224, , p 19) 11 Commission Regulation2722/2000 of 13 December 2000 establishing the conditions under which the Financial Instrument for Fisheries Guidance (FIFG) may make a contribution towards the eradication of a pathological risk in aquaculture (OJ L 314, , p10) 12 In particular cases of epidemiological significance; to comply with Articles and of the said Code;