The fundamental objective of the European Union policy for animal health is to protect the animal population from transmissible diseases and other pathological conditions that may have negative effects on their health, their welfare and the health of humans.

"A zero-risk approach is not a realistic option," she commented. EU control measures for AI are set out in Council Directive 2005/94/EC, which came into force on 1 July 2007. Covering poultry and 'other captive birds', notification and measures for the low-pathogenic form of AI (LPAI) are now required. Graduated measures are in place for highly pathogenic forms of AI (HPAI) and low pathogenic forms (LPAI) of the H5 and H7 sub-types that have potential to mutate into HPAI.

New EU Control Measures for AI

Ms Pittman explained how the new control measures are more flexible and risk-based. The principle eradication measure is 'stamping out' (culling) of birds on all infected holdings at risk. However, derogations are possible, for example, for non-commercial holdings. More stringent measures, including a standstill on all poultry movements within a region of a Member State territory with a high poultry population density may be imposed.

Zoning involves movement restrictions for live poultry, poultry products (fresh meat, eggs, manure) as well as vehicles and people around an infected farm. For HPAI, a protection zone of 3km is surrounded by a 10km surveillance zone. With a 1km restricted zone around an LPAI outbreak, poultry farms will be identified and biosecurity measures tightened as the farms are examined and samples taken for lab testing.

Decision 2006/415/EC covers the H5N1 sub-type of HPAI in poultry, action depends on whether the outbreak is in a high- or low-risk area. Areas designated by the Directive as high-risk require the 3km protection and 10-km surveillance zone. Low-risk areas have a larger surrounding buffer zone and carry some additional restrictions relating to manure, untreated feathers and pet foods as well as a ban on hunting. The area must be reported in the EU Official Journal, giving full transparency to other Member States and trading partners.

In 2007, a total of 26 HPAI outbreaks were notified in the EU, a slight fall from 34 the previous year. Early detection of the virus is crucial to the control of AI. Since it has been established that the HPAI virus is carried by wild birds, there has been a shift in emphasis towards surveillance in both poultry and wild birds. This is carried out according to harmonised EU guidelines and an online reporting system - co-financed by the Commission - was introduced in 2007.

AI Vaccination Limited

Ms Pittman raised the controversial topic of vaccination against AI in both emergency situations and for prevention. The decision will be based on a risk assessment. Vaccines may be approved nationally by the Community through an accelerated procedure through the European Medicines Agency (EMA). Currently, three inactivated are available, based on the H5N2, H5N3 and H7N1 virus types. Before vaccination can begin, Member States must submit vaccination plans for formal EU approval, fully describing the disease situation and plan (number of birds to be vaccinated, vaccine to be used and duration). Surveillance of the vaccinated birds must be followed by a DIVA (Differentiating Infected from Vaccinated Animals) strategy. Currently, vaccination has limited application in the EU, with just four countries and zoo birds covered.

Poultry products, particularly meat, are widely traded across international borders. Preconditions for imports from third countries include assessments of veterinary services, legal and financial powers and issues of both animal and public health. Trade restrictions in relation to AI include a ban on imports of live poultry, hatching eggs ad poultry products that can transmit the virus from third countries where H5N1 HPAI is present and from where such imports are authorised. Currently, only 10 third countries are authorised to export live poultry and eggs to the EU. Regionalisation is a concept recognised by the EU and the World Organisation for Animal Health (OIE), limiting any ban to a restricted area. There are permanent restrictions on the import of unprocessed feathers. Among several risk-mitigating factors are heat treatment of meat products or quarantine and testing in the case of live birds, as well as direct import to the end-user.

Compartmentalisation versus Regionalisation

Th regionalisation of imports takes a geographical approach. Third countries are expected to be given complete transparency, have high quality veterinary services and comply with OIE standards. In particular, all efforts must be taken to maintain AI-free status, including surveillance both within and outside the affected region, with rapid disease detection and appropriate control measures.

Importantly, compartmentalisation is based more on functional separation rather than geography. It offers an entry for highly biosecure products to derogate from standard health policy measures such as culling in case of an outbreak in the zone. In fact, this is not a new concept, but is based on industry needs and the capacity to maintain a higher health status regarding a specific disease. Vital to success is mutual trust - between the industry and the authority and between trading partners.

Compartmentalisation is based on international standards, including an OIE Code including a general chapter and specific guidelines, which are due to be adopted at the end of May 2008. Participation includes not only EU countries but the 172 members of OIE. Ms Pittman emphasised that the guidelines will evolve over time, based on input from field experiments and experience.

OIE defines a compartment as a sub-population of animals of the same health status and under one biosecurity plan. This must cover not only risk assessment but also a partnership between the industry and veterinary authority, their respective responsibilities and auditing schemes (both private and official). The initiative comes from the industry, is endorsed by the competent authority and finally, validated between importing and exporting countries. The measures are based on epidemiology rather than a defined template of rules. The principles of the EU Draft Regulation have been accepted and the challenge now is to implement it in practice. The first text is currently under review by the 27 Member States, and there are parallel discussions with both the industry and four major trading partners (USA, Canada, Australia and New Zealand) and Brazil has asked to be included. Practical implementation with so many partners is clearly going to be complex, and so it has been decided to start by laying down rules for the EU internal market, where the biosecurity measures and plans are well known by the industry.

The basis is the international model for risk analysis, Hazard Analysis and Critical Control Points (HACCP), which is already widely used in the poultry industry. The time frame depends on international reaction but the first standards are due to be put forward in May 2008.

Future Challenges

Challenges that will have to be resolved later include any differences with the OIE Code, costs and full staff training. A further issue will be how to deal with cross-border compartments, given that there are a number of large integrated poultry companies. For the poultry sector, the first rules of the Draft Regulation will cover AI and Newcastle disease. It is hoped that the final version will cover bilateral agreements for exports, the regulation of imports and finally, bilateral agreements for imports.

In conclusion, Ms Pittman emphasised that the ultimate responsibility for the success of these arrangements is the head of the veterinary service of the exporting country, adding that transparency, confidence and trust are vital for success.

May 2008