Chapter 8 “Balai” Directive of the European Union: Difficult Veterinary Legislation
On 13 July 1992, the Council of the European Communities adopted the “Directive 92/65 laying down the animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC.”1 This directive is more concisely referred to as one of two “Balai” directives, the other being Directive 92/118/EEC, governing trade in certain products under animal and public health criteria. The term balai is French, meaning “broom.” It is used in this context because, with a view of completing the European Union’s internal market, all veterinary issues that were not yet regulated were swept together and packed in the two directives. Because of time constraints, Directive 92/65 was prepared hastily and without consulting with the zoo community. It was poorly drafted, in particular its English version, and thus unclear, misleading, and impractical. Even the veterinary services of the member states apparently were taken by surprise when the European Union (EU) Council signed the proposal as a directive in July 1992, to take effect on 1 January 1994.
Neither the authorities of the member states nor the commission itself seemed to appreciate the different animal species involved or the type and number of annual movements of animals between zoos, or that the majority of these transactions were for conservation breeding purposes. In practical terms, the directive proved to be an obstacle for the exchange of zoo animals rather than facilitating these movements. Consequently, zoos hesitated to seek approval under the directive, and national governments were rather slow in implementing it.
After the European Association of Zoo and Wildlife Veterinarians (EAZWV) was founded in 1996, it became a driving force for revision of the “Balai” Directive, with considerable effort to communicate with EU officials. Expert work was concluded in March 2001, and the amended directive adopted by the EU Council on 15 July 2002.
Under the prevailing legislative procedures in the EU, amending the core body of the directive was difficult. Instead, Annex A, containing the list of diseases relevant for the directive; Annex C, defining the conditions for approval; and Annex E, containing model certificates, were amended. Because the amendment was done in the legal form of a regulation, annexes A, C, and E became directly applicable in member states, which should guarantee a relatively uniform application. EAZWV wanted the implementation as uniform as possible, because only this would ensure that the sanitary level of all approved zoos followed the same high standard, which would permit the circulation of animals between approved zoos with minimal health risks.
This implied that zoo veterinarians (1) were fully aware of the provisions of the revised “Balai” Directive, (2) would take their obligations under the directive seriously, (3) would approach their duties in a uniform way, and (4) were also prepared to cover a number of diseases not, or not explicitly, addressed by the directive. To this end, EAZWV organized a “Balai” workshop at its 2002 conference in Heidelberg, presenting the contents of the revised “Balai” Directive to zoo veterinarians and directors at different meetings. EAZWV also established an infectious diseases working group, chaired by Jacques Kaandorp of Beekse Bergen Safari, with the mandate of developing a transmissible diseases handbook,6 and hired a part-time veterinarian to act as secretary of the working group.
During the negotiations, two surveys were conducted to ascertain how EU member zoos were using the original “Balai” Directive. Few substantial answers were received, and it became clear that veterinary services had no uniform interpretation of the directive; most had not even seriously dealt with the new piece of legislation. Compliance was highly variable. Most respondents wanted a revision, although a few were satisfied with their approach. It was evident that quarantine facilities and record keeping were inadequate.
The conclusion from the two surveys was that EAZWV should provide guidance to both zoos and veterinary services throughout the EU as well as in Andorra, the British Crown Dependencies (Channel Islands, Isle of Man), Liechtenstein, Monaco, Norway, San Marino, and Switzerland, where the “Balai” Directive also is applicable, either under the Agreement on the European Economic Area (EEA) or under bilateral treaties.
To this end, two meetings were held on 15/16 September 2003 and 5 February 2004 at Cologne Zoo with the participation of representatives of the European Commission (DG SANCO: Health and Consumer Protection); British Department for Environment, Food & Rural Affairs (DEFRA); Dutch Rijksdienst voor de Keuring van Vee en Vlees (RVV); German Bundesministerium für Verbraucherschutz, Ernährung und Landwirtschaft (BMVEL); the EAZWV, in particular its Infectious Diseases Working Group (IDWG); and zoo veterinarians from France, Germany, Italy, The Netherlands, and the United Kingdom, representing also their respective professional organizations at the national level.
The recommendations, which were finalized on 20 February 2004, were disseminated as part of the EAZWV Transmissible Diseases Handbook6 by EAZWV and the European Association of Zoos and Aquaria (EAZA) to their respective constituencies and by the EU Commission to the veterinary services of the member states, which implied that they received some type of official status. The recommendations contain six chapters dealing with the term “animals,” the approved veterinarian, annual disease surveillance plan, added-animals procedure, quarantine/isolation requirements, and the certificates:
“Animals” in the terms of Article 2(b) of the directive means “specimens of animal species other than those referred to in Directives 64/432/EEC, 90/426/EEC, 90/539/EEC, 91/67/EEC, 91/68/EEC, 91/492/EEC and 91/493.” The average zoo veterinarian has no clue what this means, and even many official veterinarians may have problems finding out what exactly is covered by the directive, and what is not. Therefore a list of the species covered by the various other directives is provided. The recommendations state, however, that it would make no sense to exclude these species not addressed by the “Balai” Directive from the health surveillance plan.
To be granted official approval under Article 13 of the directive, a zoo must secure by contract or legal instrument the services of a veterinarian approved by and under the control of the competent authority. The role of the approved veterinarian is to ensure that the requirements of the “Balai” Directive and other related legislation are complied with on a day-to-day basis. Where this veterinarian is a member of a practice, other members of the same practice may be included, provided that they are also approved by the competent authority and individually nominated in writing.
Also in the case of the approved veterinarian, the “Balai” Directive refers to other EU legislation by requiring that approved veterinarians comply mutatis mutandis with the requirements referred to in Article 14(3)(B) of Directive 64/432/EEC; the recommendations explain what this exactly means. It was agreed with the EU Commission that one of these requirements, according to which the approved veterinarian must have no financial interest or family links with the owner of or person responsible for the holding, could be interpreted liberally because zoo animals have a conservation value rather than an economic value and because, for the purposes of the “Balai,” the approved veterinarian is working under the supervision of the official veterinarian. It is thus the official veterinarian’s duty to assess whether a conflict of interest could exist, and whether the veterinarian appointed by the zoo fulfills the requirements for being approved, and in particular has appropriate specialist knowledge in relation to zoo animals.
The approved veterinarian must draw up and implement an annual disease surveillance plan. This plan is subject to annual audits by an official veterinarian from the competent authority. The recommendations explain that, for the purposes of approval under the “Balai” Directive, the surveillance plan must cover those diseases listed in Annex A (and B if relevant), and suggest that the plan may also include other general measures as may be required under Council Directive 1999/22/EC of 29 March 1999, relating to the keeping of wild animals in zoos,2 and specific measures for individual taxonomic groups as may be agreed by the relevant Taxonomic Advisory Group of the European Endangered Species Program (EEP) of the EAZA. As a general rule, such specific measures would be elaborated by the EAZWV IDWG and subsequently integrated into the Husbandry Guidelines for the taxon concerned.
As agreed with the representatives of the EU Commission and the national veterinary services participating in the Cologne meetings, the annual disease surveillance plan and associated measures must include the following: