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FMD is not dangerous for human health but outbreaks of this highly contagious viral disease in livestock have an exceptional economic and psycho-social impact on the rural and national economy in the EU. The Directive sets out detailed measures to rapidly control and eradicate the disease and outlines procedures on recovering the status "free of FMD and infection without vaccination", which is of crucial importance for trade. Control actions are supplemented with measures to ensure a high level of preparedness against the disease. The Commission is given a key role in managing an outbreak in partnership with the Member States. The Directive enters into force on the day of its publication in the Official Journal of the European Union. Member States must comply with the provisions by 30 June 2004 at the latest.

David Byrne, Commissioner for Health and Consumer Protection, welcomed Council's adoption of the Directive. "Outbreaks of foot-and-mouth disease in individual Member States impact on the EU as a whole, as we saw in 2001. The new law aims to maintain or, in the event of an outbreak, quickly regain the 'FMD-free' status that is of key importance for trade in animals and animal products. Emergency vaccination is moved to the forefront of control measures instead of being the last resort. The new legislation is a true reform."

The new law won broad support from the European Parliament, the European Committee of the Regions and the European Economic and Social Committee as reflecting the lessons learned from the 2001 outbreak.

Emergency vaccination as an early response in the case of an outbreak

The details of the Directive range from the notification of a suspect case through to the measures to be taken in relation to animals and their products during an outbreak until disease- and infection-free status is regained. It makes provisions for a high level of disease preparedness, notably contingency planning and vaccine banks, and also covers the possibility of infection in wildlife.

Being a carefully considered reform rather than a revolution, there is no departure from the ban on prophylactic vaccination introduced in 1992, but the emphasis on various control measures is shifted by moving emergency vaccination further to the forefront of the control strategy.

This approach is bolstered by modified international trade rules and laboratory tests to distinguish vaccinated from infected herds which allow the use of vaccination in a much more flexible way, albeit always in connection with rapid stamping out of infected or contaminated animals of susceptible species.

Further new elements

Prior to the confirmation of an outbreak, veterinary services will be empowered to establish suspect restriction zones and to impose a temporary movement ban on large parts of affected Member States.

The new law also provides for "regionalisation", limiting restrictions to the particular regions of a Member State that are affected by an outbreak. This is of particular importance where emergency vaccination has been carried out. Vaccinated animals from herds which have been tested for the absence of infection and have regained FMD free status may move within the Member State concerned but will not be allowed to be traded to other Member States. Detailed rules are laid down for the marketing of products such as milk and meat from animals from restricted areas or from vaccinated animals. These products are not dangerous to humans and restrictions on their circulation are kept to the minimum necessary to prevent the spread of any possible FMD virus, primarily through appropriate treatment or specific production conditions. The Directive outlines the measures to be taken in order to prepare for an outbreak. The main new elements are:

• Provisions are made for diagnostic facilities, in particular a Community Reference Laboratory, including a bank for diagnostic reagents, test kits, etc.
• Detailed provisions are laid down for the management of the European antigen bank and for access to this bank by Member States and, where required, third countries. Specific rules are laid down for the confidential treatment of information on the quantities and strains of antigens stored at the bank.

Emphasis is put on preparation of contingency plans, including the preparation for a "worst case" scenario. Contingency plans have to be regularly updated in the light of the results of alert exercises

Background

The EU measures for the control of FMD are currently laid down in Directive 85/511/EEC(¹). The "non-vaccination policy" was introduced by Council Directive 90/423/EEC(²), which also specified requirements for contingency planning and antigen stocks for the production of vaccines for emergency vaccination. In order to protect livestock against infection, it also made modifications to the conditions for intra-EU trade and imports from third countries of susceptible animals and animal products, such as milk and meat. The proposal for a new FMD Directive is based on the experience with classical swine fever in 1997 and the application in 2001 of the current measures for FMD control as well as intensive stakeholder consultation, and the report of the European Parliament adopted on 17th December 2002.

(¹)OJ L 315, 26.11.1985, p. 11.
(²)OJ L 224, 18.8.1990, p. 13

Source: European Commission - 29th September 2003