Humanitarian Resource Institute:  A U.S. & International Resource on the Scope of Humanitarian Assistance
June 12, 2003

Stephen M. Apatow
Director of Research and Development 
Humanitarian Resource Institute Biodefense Reference Library
Foreign Animal and Zoonotic Disease Center
Eastern USA: (203) 668-0282   Western USA: (775) 884-4680


European Union Online: Press Releases

FMD: Byrne welcomes political agreement on improved Directive to control outbreaks

DN: IP/03/831     Date: 12/06/2003


Brussels, 12 June 2003

The Council of Agriculture Ministers achieved today political agreement on revised and improved legislation on EU measures to control outbreaks of foot-and-mouth disease (FMD). 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 amended Directive details the 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.

Welcoming the agreement and congratulating the Greek Presidency, David Byrne, Commissioner for Health and Consumer Protection, said: "Outbreaks of foot-and-mouth disease in individual Member States impact on the EU as a whole as we saw in 2001. The amended 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 agreement is a true reform."

The new draft law has 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 draft law 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 draft 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 absence of infection, may after regaining the FMD free status move within the Member State concerned but not 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 required to prevent spread of possible virus, primarily through appropriate treatment or specific production conditions.

The draft 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


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.


Vaccines and foot and mouth disease
Thursday, 12 June 2003

European Agriculture Ministers have today agreed a proposal for EU-wide measures on the control of foot and mouth disease, including the requirement for Member States to have arrangements in place for possible use of emergency vaccination as soon as the disease is confirmed.

The Food Standards Agency announced in April 2001 that it was satisfied that eating meat, milk or other produce from animals that have been treated with authorised foot and mouth disease vaccines would not have any implications for food safety.
Nor did the FSA consider that there would be any need to label meat products derived from animals that have been vaccinated with the food and mouth disease vaccine.

All vaccines for food animals have to be given a licence before they can be used.

As part of the licensing process, the Government’s independent expert committee, the Veterinary Products Committee, thoroughly assesses the safety of the vaccine to ensure that its use will not pose any threat to human health.

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