Opinion on the proposal for a Council Directive amending and updating Directive 64/432/EEC on health problems affecting intra-Community trade in bovine animals and swine (1) (94/C 133/10)

On 1 February 1994 the Council decided to consult the Economic and Social Committee, under Articles 43 and 198 of the Treaty establishing the European Community, on the abovementioned proposal.

The Section for Agriculture and Fisheries, which was responsible for preparing the Committee's work on the subject, adopted its Opinion on 3 February 1994. The Rapporteur was Mr Proumens.

At its 313th Plenary Session (meeting of 23 February 1994), the Economic and Social Committee unanimously adopted the following Opinion.

The Committee endorses the Commission's move to issue an updated and consolidated version of Directive 64/432/EEC, which has been amended over 40 times.

Subject to the comments and recommendations which follow, the Committee also approves the efforts to simplify and clarify the resultant text.

1. General comments

1.1. The Committee notes the removal of certain control provisions, residence requirements and tests.

Given the single market and the experience acquired, particularly as regards the tests, it can be stated that such provisions are no longer needed, either because they have been made obsolete by the removal of frontiers or because the favourable animal health situation in the EU has made the tests unnecessary.

1.2. In general terms, the Committee asks the Commission to urge the relevant authorities of the Member States to see that the remaining control measures are as effective as possible, notably by providing skilled staff and a sufficient number of inspectors and veterinarians.

1.3. Subject to the comments set out below, the Committee has noted that any changes to the Annexes will be effected according to the Standing Veterinary Committee (SVC) procedure.

This procedure, which mainly applies to technical and veterinary science provisions, has the advantage of involving specialists and of allowing adaptations and alterations to be made swiftly; if these provisions were included in the body of the Directive they would be subject to the traditional Council Directive procedure which takes much longer.

1.4. Any doubts about the use of a purely administrative procedure are misplaced: SVC members are of high professional standing; the procedure is not new; and there are no signs that the relevant authorities have overstepped their remit.

2. Specific comments

2.1. Article 2(a): The Committee considers that the definition of 'holding' used in Article 2 of Directive 90/425/EEC should be reproduced in full, as this would make the proposal easier to follow.

2.2. Article 2(b): The Committee thinks that the intention might not be fulfilled (for example, an animal could be taken to market but not sold, and then return to the holding).

2.3. Article 3(1): The Committee considers that the term 'where applicable' is unclear.

2.4. Article 4(1): Without the possibility of controls, these provisions appear rather academic. While it might be possible to seal the vehicle before departure, the provisions governing the transport of animals (food, watering, rest or penning areas) would make this unfeasible on long journeys.

2.5. Article 5(1): The drawing up of the certificate 'in one of the official languages of the country of destination' might pose problems. However, given the existence of a standard model form and the competence of the drafters, the problems should not be insurmountable. Any other solution would present the same disadvantages.

2.6. The Committee notes the extreme complexity of the other provisions of Article 5, concerning the various certificates which must be drawn up during the successive stages of transport. However, they are the only way to guard against undue laxity which would undermine the requisite precautions.

3. Comments on the Annexes

3.1. Annex A

3.1.1. Chapter I, Point 1: A bovine holding is tuberculosis-free if clean-up operations have been conducted properly.

Point I.1 lays down the additional requirements which allow a holding to be classified as officially tuberculosis free by the EC, while Point I.2 lays down those which allow it to retain that status.

3.1.2. Chapter I, Point 1(a): This may seem superfluous in view of the requirements of 1(b) and (c). However, it is possible that if an animal's resistance to infection is seriously weakened it may develop clinical tuberculosis accompanied by manifest symptoms but tuberculin test-results will be negative because of anergy.

3.1.3. Chapter I, Point 1(c): This seems rather paradoxical. A holding loses 'officially tuberculosis free' status if an intradermal-positive animal is introduced into it. Such a situation could occur if the test is carried out in the 30 days following introduction (this being offered in 1(c) as an alternative to a test 30 days prior to introduction).

It would seem wiser to retain only the first alternative (test carried out at the holding of destination), as the farmer will give greater credence to what happens on his own holding, and can have the sale legally annulled and force the vendor to take the animal back. It is clear that in either case the vendor will do his utmost to deliver a disease-free animal, in order to avoid the inconvenience of taking it back or, preferably, slaughtering it on the spot if it tests positive.

This is only a suggestion; the alternative solution is also valid.

3.1.4. Chapter I, Point 2(b): This is stricter than 1(b). A farmer who has made an effort to clean up his holding should be allowed to benefit from this and to draw on similar officially tuberculosis-free holdings in order to renew, improve or extend his stock.

Chapter I, Point 2(c): The frequency of routine tests is proportional to the percentage of infected holdings, and checks in these are much more frequent after a clean-up operation.

3.1.5. Chapter I, Point 3(b): This concerns the conditions under which the suspension of officially tuberculosis-free status may be revoked (following opposition to a positive or inconclusive test or to the diagnosis of tuberculosis at a post mortem examination in a slaughterhouse or elsewhere).

3.1.6. Chapter I, Point 4(a): For a Member State or part of a Member State to be declared officially tuberculosis free, it must have been controlling the disease for ten years. The initial situation must have been extremely favourable (99,9 % of holdings officially free), and conditions for later years are even stricter (99,99 % free for the last six consecutive years).

3.1.7. Chapter I, Point 4(c): This implies that all the animals are to be slaughtered in a slaughterhouse, as they are to undergo a post mortem examination by an official veterinarian.

3.1.8. Chapter I, Point 4(d): There seems to be a mix-up in terminology here. While suspected cases of tuberculosis among 'herds of origin or transit' (a term which is not defined anywhere, while 1(b) speaks of 'assembly') are being examined, these herds lose their officially tuberculosis-free status; yet 3(b) only requires status to be suspended in the more serious situation of clinical tuberculosis or a positive reaction to a tuberculin test.

Both cases would seem to mean a suspension.

Points 5(b) and (c) also confuse suspension and withdrawal.

Point 6: There is a typing error in the last line: the reference should be to 2(c), not 2(d).

3.1.9. Chapter II, Point 4: A distinction is made here between 'brucellosis free' and 'officially brucellosis free', the latter term guaranteeing the absence of vaccination.

However, Point 2(c) allows an animal from a brucellosis-free holding to be introduced into an officially free holding (the latter holding is then downgraded to 'brucellosis free' for two years from the date on which the animal is introduced), provided that the animal concerned shows a brucella count lower than 30 iu of agglutination per ml; this is because it is impossible at a higher count to distinguish between a vaccinated animal and an infected animal, as the complement fixation test is negative in both cases.

A battery of negative laboratory tests is, however, admissible for the purposes of harmonizing the result of the different tests chosen by national legislation.

3.1.10. Chapter II, Point 2(b): This again raises the problem of checking that animals do not come into contact with animals of a lesser health status during transport.

The sealing of a vehicle upon departure would be one answer, but the vehicle would have to be resealed en route in order to comply with the Directive on the protection of animals during transport. This specifies the maximum period which may elapse before feeding, watering and rest, in line with the checks required under Article 5 of the present proposal (to which the present Annex relates) with reference to assembly centres and approved markets.

All this would seriously impede transport conditions.

In any case, in health terms, it would be difficult to establish whether responsibility lay with the transport operator.

3.1.11. Chapter II, Point 3(b): This states that a holding's officially brucellosis-free status may be suspended if the animal is immediately destroyed or isolated.

However, it does not specify (third paragraph) for what period of time it is admissible for the animal to be reintroduced if the laboratory analyses prove negative.

3.1.12. Chapter II, Point 4: Vaccination is permitted in brucellosis-free holdings, but there are stringent restrictions on the serological consequences and on:

3.1.13. Point 5: The animals to be introduced in these holdings.

3.1.14. Point 6: Brucellosis-free holding status is withdrawn if the suspect animal proves to be infected.

The isolation period needed to establish the laboratory or epidemiological diagnosis (regarding the holding of origin) is not specified or mentioned.

3.1.15. Chapter II, Point 9: The Commission is to propose whether a Member State should suspend or revoke officially brucellosis free status.

Who approves and implements this, or rejects it ?

The answer is the relevant national authority, in a spirit of mutual trust, and this may generate confusion in the event of a rejection. In all cases, the decision lies with the Standing Veterinary Committee (Articles 12 and 13 of the proposal).

Refusal to carry out routine tests requested by the Commission seems difficult to justify in the framework of intra-Community trade.

3.2. Annex B

3.2.1. Point 26: It would help the person carrying out a test using an officially controlled tuberculin if the expiry date was indicated on the container (i.e. in the first list of point 26).

3.2.2. Point 32(d): This gives a stricter interpretation of the intradermal test ('increase in skin fold thickness greater than 2mm'), remembering that Point 32(a) considers 2mm as 'inconclusive' and as necessitating a further test after 42 days.

3.3. Annex D

3.3.1. Point F(i): After the words '20 % of bovine animals over two years of age', the Committee suggests adding 'chosen at random' in order to avoid any misunderstanding about the remaining 80 % which might appear to escape checks.

3.3.2. Point F(ii): 'where no case' could be taken to mean 0 %. It might be wiser to say 'where a maximum of one case per 10 000, i.e. 0,01 %'.

3.4. Annex E (II)

3.4.1. The fact that the list of contagious diseases appears in an Annex means that it can be modified more easily.

In order to clarify the health status of these diseases, it might be useful to add, after the words 'diseases listed in Annex E(II)', 'which are not subject to regulations concerning the status of the holding, region or Member State (officially) free'.

Done at Brussels, 23 February 1994.

The Chairman

of the Economic and Social Committee

Susanne TIEMANN

(1) OJ No C 33, 2. 2. 1994, p. 1.