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APPENDIX 5: INTERNATIONAL ORGANISATIONS
THE WORLD ORGANISATION FOR ANIMAL HEALTH ( OIE)
The Terrestrial Animal Health code
The World Organisation for Animal Health ( OIE) is an intergovernmental organisation created in 1924, which currently has around 167 Member Countries. In 1994 the World Trade Organisation ( WTO) recognised the OIE as the international reference body with responsibilities under international law for specifying the standards, guidelines and recommendations applicable to international trade.
The Terrestrial Animal Health Code (the Code) is produced by the OIE and details the health measures and safeguards which veterinary authorities should adopt in relation to imports and exports of animals and their products. These measures are important to ensure that importing countries are protected and that pathogenic agents such as FMD are not transferred during trade. Under the rules of the WTO it is equally important to ensure that any import/export controls are based on risk and do not create unjustified sanitary barriers.
The Code is divided into four parts, each of which has relevance to FMD.
- Part 1 deals with general provisions and includes sections on general definitions, risk analysis including zoning and compartmentalisation and import export procedures.
- Part 2 deals with the priority diseases with a specific chapter devoted to FMD. This provides recommendations to prevent the introduction of specific diseases into the importing country by taking into account the disease, the commodity and the status of the exporting countries.
- Part 3 contains a number of appendices of which appendix 3.8.7 deals with detailed guidelines for the surveillance of FMD.
- Part 4 provides a number of model international veterinary certificates for use in live animals and their products in order to assist with in harmonisation.
The Code is now an integral part of the regulatory system established by the WTO for trade in animals and their products. Veterinary authorities are encouraged to base their import health measures on the OIE standards. In the case of the EU much of the current measures are based on the OIE standards. Whilst countries should follow the OIE standards there is no specific legal obligation for them to do so although if they do not and a complaint is made to the WTO, failure to comply with the standards could be serious. It is EU legislation which dictates what rules and standards have to be followed by Member States including the UK.
OIE standards on regionalisation
In Part 1 of the Code the OIE defines a zone or region as "a clearly defined part of a country containing an animal subpopulation with a distinct health status with respect to a specific disease for which required surveillance, control and biosecurity measures have been applied for the purpose of international trade". For the purposed of the Code 'zoning' and 'regionalisation' have the same meaning.
A free zone is defined as "a zone in which the absence of the disease under consideration has been demonstrated by the requirements specified in the Code for free status being met. Within the zone and its borders, appropriate official veterinary control is effectively applied for animals and animal products, and their transportation".
An infected zone is simply defined as a zone in which the absence of the disease under consideration has not been demonstrated by the requirements specified in the Code being met.
The buffer zone means a zone established to protect the health status of animals in a free country or free zone from those in a country or zone http://www.oie.int/eng/normes/mcode/en_chapitre_1.1.1.htm - terme_zone_region
of a different animal health status, using measures based on the epidemiology of the disease under consideration to prevent spread of the causative pathogenic agent into a free country or free zone. These measures may include, but are not limited to, vaccination, movement control and an intensified degree of disease surveillance.
Part 2 of the Code dealing with FMD specifies the conditions under which FMD freedom can be obtained and maintained. The chapter also details the procedures for regaining freedom in the event of outbreaks in the free country or free zone. Equally important, the standards recommended by the OIE for movements within and between countries or zones of differing disease status are detailed.
The movements of live animals are prohibited and movements of meat are restricted out of an infected zone. In the case of the buffer zone, meat may be traded provided that it is traceable to an origin outside the infected zone. Live animals cannot move out of this zone to the free zone but should be able to move into the infected zone for slaughter. Within the free zone normal movements are allowed of both live animals and meat but with certification to assure importing countries that they do originate in the free zone. This was the situation with Northern Ireland during the whole of the period in 2007.
On this basis trade would be subject to the following principle. Controlled movements would be permitted from free to low to high risk areas but not in reverse. Detailed rules for the trade between the different zones are available in the OIE Terrestrial Code. In some circumstances such as animals moving direct for slaughter, the animals would be allowed to go from the high risk areas into lower risk areas but under very strict controls which would reduce any risk of infection being spread.
THE ROLE OF THE EUROPEAN UNION
Decision making in the European Union
European Union ( EU) law has direct effect on the Member States, and overrides national law in many areas. The European Parliament, the European Commission (the Commission) and the Council of Ministers are empowered by the Treaties to legislate on all matters within the EU's competence. Secondary legislation includes Regulations, Directives, Decisions, Recommendations and Opinions. Of specific relevance to FMD are the control Directive and the Commission Decisions produced at the time of the outbreak.
A Directive requires Member States to achieve a particular outcome without dictating the means of achieving that result. Normally they are transferred within a certain deadline into national laws by the national parliaments. Directives can be distinguished from EU Regulations which are self-executing and do not require any implementing measures. The reasoning behind the Directives is that it allows Member States to take account of special domestic circumstances when implementing Community rules. In principle they are free to determine the form and methods used to transpose their Community obligations into domestic law. If a Member State fails to pass the required national legislation, or if the national legislation does not adequately comply with the requirements of the Directive, the Commission may initiate legal action against the Member State in the European Court of Justice.
Council Directive 2003/85/ EC of 29 th September 2003 on Community measures for the control of FMD, repealing Directive 85/511/ EEC and Decisions 89/531/ EEC and 91/665/ EEC and amending Directive 92/46/ EEC, is the basis for the control measures used in an FMD outbreak. This Directive was produced following the 2001 outbreak and many of the measures are linked to the lessons learned from that outbreak. However the controls are directed to an outbreak such as the FMD 2001 outbreak and are not always appropriate for the smaller contained outbreak which occurred in 2007.
Whilst a Directive such as this binds the Member State to achieve certain targets the national authorities have choice of form and method of implementation. This choice in the case of the UK is exercised by the UK Department or Devolved Administration concerned which in the case of FMD are Defra and the devolved authorities in Northern Ireland, Scotland and Wales. The consequence is that provided the Scottish Government meets the requirements of the Directive they may implement the provisions in a different way to other UK administrations as animal health policy has been devolved to Scotland.
A Decision is EU law which is not of general application, but of individual application, i.e. it only applies to the particular addressee (persons, companies, Member States) of the Decision. It is distinguished from a Directive by being binding in its entirety. In the case of the FMD outbreak of 2007 the Commission Decisions were addressed to all Member States and laid down the rules under which all should operate.
The Standing Committee on the Food Chain and Animal Health ( SCoFCAH) has representatives from the 27 Member States and the Commission. In the case of an FMD outbreak the representatives on the committee will be officials from the veterinary services of the Member States or from their country's permanent representations in Brussels.
The committee is chaired by a representative of the Commission Directorate General for Health and Consumer Protection ( DGSANCO). In the event of the FMD outbreak in GB the Commission would propose a Decision and the members of the committee would discuss and vote on the Decision. In general the Commission will attempt to obtain a unanimous agreement to the proposal. However Decisions can be taken by qualified majority voting. The UK has 29 votes, the same as France, Germany and Italy. A total of 255 votes out of a possible 345 votes are needed to pass a Decision.
From this it can be seen that the UK acting alone is unable to block a Decision and to achieve its aims the UK must provide good scientific arguments and appropriate evidence. Lobbying other Member States and the Commission is important to obtain the best outcome for the UK. In general when dealing with FMD outbreaks the Member States need time to digest the information provided by the UK and will err on the side of caution. Equally the Commission will not be swayed by the economic arguments against a perceived uncertainty in the epidemiology.
EU legislation on FMD regionalisation
The basis of the EU animal health policy is to prevent the introduction into, or spread within, the EU of pathogens. To achieve this there is harmonised legislation on imports and livestock identification and movements along with harmonised control measures for specified diseases such as FMD. Wherever possible the EU bases the disease legislation on the provisions laid down in the OIE Terrestrial Code As the principles of regionalisation have been agreed at OIE level they are embedded into the overall EU strategy for disease control.
It has to be recognised that the role and responsibility of the Commission in the event of an outbreak in a Member State is twofold. Firstly to protect Member States and third countries from a disease by imposing a risk based and proportionate ban on exports from the affected Member State in order to protect the others. Secondly the European Commission has an interest in the efficient eradication of the disease as this will both enhance the protection of the other Member States and also permit a resumption of trade in animals and their products.
A specific definition of regionalisation is contained in Directive 2003/85/ EC Article 2 q to s inclusive. "Regionalisation means the delimitation of a restricted zone in which restrictions are applied on the movements of or trade in certain animals or animal products as provided for in Article 45 in order to prevent the spread of FMD into the free zone where no restrictions are applied in accordance with this Directive". A region "means an area as defined in Article 2(2) (p) of Directive 64/432/ EEC; whilst a sub region means an area specified in the Annex to Decision 2000/807/ EC".
Under article 45 of Directive 2003/85/ EC Member States are required to regionalise into one or more restricted and free zones when FMD virus appears to be spreading despite the measures taken in accordance with this Directive and the epizootic becomes extensive and in any case when emergency vaccination is implemented. The Commission can review and amend the regionalisation introduced by the Member States as can SCoFCAH. The restricted zone should be delimited on the basis of administrative boundaries or geographical barriers.
The important component of this Directive is that the restricted zone may be reduced in the light of the results of the epidemiological inquiry to an area of the size not less than a sub-region, and where necessary the surrounding sub-regions. In the event of the FMD virus spreading, the restricted zone could be enlarged by including additional regions or sub-regions. It is this which is of importance in freeing up the country.
The European Communities are convinced that regionalisation is the best approach to maintain adequate disease control with minimum restrictions to trade. Regionalisation and a high level of protection are compatible and can be implemented in the single market.
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