COMMISSION IMPLEMENTING DECISION (EU) 2018/1136

of 10 August 2018

on risk mitigation and reinforced biosecurity measures and early detection systems in relation to the risks posed by wild birds for the transmission of highly pathogenic avian influenza viruses to poultry

(notified under document C(2018) 5243)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 2005/94/EC of 20 December 2005 on Community measures for the control of avian influenza and repealing Directive 92/40/EEC (1), and in particular Article 3 and Article 63(3) thereof,

Whereas:

(1) Avian influenza is an infectious viral disease in birds, including poultry. Infections with avian influenza viruses in domestic poultry cause two main forms of that disease that are distinguished by the virulence of the virus. The low pathogenic form generally only causes mild symptoms, while the highly pathogenic form results in very high mortality rates in most poultry species. That disease may have a severe impact on the health of domestic and wild birds and the profitability of poultry farming.

(2) Directive 2005/94/EC sets out the minimum control measures to be applied in the event of an outbreak of that disease in poultry or other captive birds and also provides for certain preventive measures relating to the surveillance and the early detection of avian influenza.

(3) Wild birds, in particular migratory water birds, are known to be the natural host for avian influenza viruses of low pathogenicity which they carry, usually without showing signs of that disease, during their seasonal migratory movements. However, since 2005, highly pathogenic avian influenza (HPAI) viruses of the H5 subtype have shown to be able to infect migratory birds which can then spread these viruses over long distances between continents.

(4) The presence of avian influenza viruses and in particular HPAI viruses in wild birds poses a continual threat for the direct and indirect introduction of these viruses into holdings where poultry or other captive birds are kept, in particular during the seasonal movements of migratory birds, with the risk of subsequent virus spread from an infected holding to other holdings liable to cause significant economic losses.

(5) The European Food Safety Authority (EFSA) adopted on 14 September 2017 a comprehensive scientific opinion on avian influenza (2), confirming that the strict implementation of biosecurity measures plays a key role in preventing the spread of HPAI viruses from wild birds to poultry and other captive birds (the 2017 EFSA opinion).

(6) The 2017 EFSA opinion lists the most relevant biosecurity measures to be applied continuously in different poultry husbandry systems including small size farms. It also states that certain general biosecurity principles universally apply to poultry holdings, while unique features for each holding need to be considered for optimised protection based on expert advice.

(7) The 2017 EFSA opinion assessed and identified risks for HPAI virus introduction into poultry holdings, such as the keeping together of domestic ducks and geese with other poultry species, and the risks related to certain activities, such as the release of poultry for restocking supplies of game birds, and it proposed measures to mitigate these risks.

(8) The 2017 EFSA opinion concluded that the passive surveillance of wild birds is the most effective means for the early detection of the presence of HPAI viruses in wild birds, where the HPAI virus infections are associated with mortality and it recommended the sampling and laboratory testing of wild bird target species. Subsequently, EFSA published a list of wild bird target species in its scientific report on avian influenza approved on 18 December 2017 (3).

(9) In a scientific report on avian influenza approved on 22 March 2018 (4), EFSA stated that there have not been any reported cases of human infection due to A(H5N8) or the newly emerged A(H5N5) and A(H5N6) viruses representing a reassortment of A(H5) clade 2.3.4.4 viruses with local European viruses donating the N5 or N6 gene. The A(H5N8), A(H5N5) and A(H5N6) viruses are considered to be predominantly adapted to avian species.

(10) The 2017 EFSA opinion also concluded that in certain epidemiological situations, it may be appropriate that Member States temporarily intensify certain preventive measures around the place where the HPAI virus infection was confirmed in a wild bird or in its faeces, in particular in order to assess, if transmission to poultry holdings has occurred and if biosecurity measures are effectively applied to prevent virus introduction.

(11) In order to target the bird populations that are most at risk of avian influenza infection and to ensure the effectiveness of the measures laid down in this Decision, certain preventive measures should therefore be targeted at holdings keeping poultry.

(12) Commission Implementing Decision (EU) 2017/263 (5) provided for risk mitigating and reinforced biosecurity measures to reduce the risk of the transmission of HPAI viruses from wild birds to poultry by preventing direct and indirect contacts between these populations, and it required the Member States to identify the areas of their territory that are at particular risk for the introduction of HPAI viruses into holdings where poultry or other captive birds are kept (‘high risk areas’), taking into account, amongst other things, the epidemiological situation and specific risk factors. That Implementing Decision applied until 30 June 2018.

(13) The measures laid down in Implementing Decision (EU) 2017/263 should therefore be reviewed taking into account the current epidemiological situation in poultry, other captive birds and in wild birds in the Union and in risk-relevant third countries, the 2017 EFSA opinion and subsequent scientific reports on avian influenza and the Member States' experience gained in the implementation of the measures laid down in that Implementing Decision.

(14) Accordingly, in view of the ongoing threat of HPAI virus transmission by infected wild birds, and the risk of outbreaks in holdings where poultry or other captive birds are kept, updated measures, taking into account the results of the review of Implementing Decision (EU) 2017/263, should therefore be laid down in this Decision.

(15) The experience gained in the implementation of the measures laid down in Implementing Decision (EU) 2017/263 shows that certain derogations from risk mitigation and reinforced biosecurity measures are necessary in order for individual Member States to be able to adapt these measures to the changing epidemiological situation.

(16) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

HAS ADOPTED THIS DECISION:

Article 1 Subject matter and scope This Decision lays down risk mitigation measures, certain reinforced biosecurity measures and early detection systems in relation to the risks posed by wild birds for the introduction of highly pathogenic avian influenza (HPAI) viruses into holdings, as well as measures to raise awareness among owners and others involved in the poultry sector of such risks and of the necessity to implement or reinforce biosecurity measures on their holdings.

Article 2 Definitions For the purposes of this Decision, the definitions set out in Article 2 of Directive 2005/94/EC shall apply.

Article 3 Identification of high risk areas for the introduction and spread of HPAI viruses 1. Member States shall identify the areas of their territory that are at particular risk for the introduction of HPAI viruses into holdings (‘high risk areas’), taking into account: (a) the risk factors for the introduction of HPAI viruses into holdings, in particular with respect to: (i) their geographical location in areas in Member States through which migratory birds are travelling or where these birds are resting during their migratory movements after having entered the Union in particular via the north-eastern and eastern migratory routes; (ii) their proximity to wet areas, ponds, swamps, lakes, rivers or the sea where migratory birds, in particular those of the orders Anseriformes and Charadriiformes, may gather and have their stop-over places; (iii) their geographical location in areas with a high density of migratory birds, particularly water birds; (iv) poultry kept in open-air holdings, where contact between wild birds and poultry cannot be prevented or sufficiently controlled; (v) current and past detections of HPAI viruses in poultry, other captive birds and wild birds; (b) the risk factors for the spread of HPAI viruses within holdings and between holdings, in particular, where: (i) the geographical location of the holding is in an area with a high density of holdings, in particular those keeping ducks and geese and any poultry with open-air access; (ii) the intensity of movements of vehicles transporting poultry and of persons within and from holdings, and where other direct and indirect contacts between holdings is high; (c) risk assessments and scientific advice in relation to the relevance of the spread of HPAI viruses by wild birds carried out by the European Food Safety Authority (EFSA) and by national and international risk assessment bodies; (d) the results of surveillance programmes carried out in accordance with Article 4 of Directive 2005/94/EC. 2. Member States shall ensure that stakeholders active in the poultry sector, including small-size holdings are informed by the most appropriate means about the delineation of the high risk areas identified in accordance with paragraph 1. 3. Member States shall keep the extent of the delineation of the high risk areas under constant review.

Article 4 Risk mitigation and reinforced biosecurity measures 1. Member States shall continuously monitor the specific epidemiological situation on their territory, taking also into account the threats posed by the detection of HPAI in poultry, other captive birds and wild birds in other Member States and nearby third countries, as well as the risk assessments referred to in Article 3(1)(c). 2. Member States shall take appropriate and practicable measures in high risk areas to reduce the risk of the transmission of HPAI viruses from wild birds to poultry. 3. The risk mitigation and reinforced biosecurity measures shall be aimed at preventing wild birds, and in particular migratory water birds, from coming into direct or indirect contact with poultry and in particular ducks and geese. 4. Depending on the assessment of the epidemiological situation referred to in paragraph 1, Member States shall prohibit the following activities in high risk areas: (a) the keeping together of ducks and geese with other poultry species, unless: (i) the risk of virus introduction is deemed insignificant due to the characteristics of the holding and the risk mitigation measures in place that are considered sufficient by the competent authority; or (ii) poultry species other than ducks and geese are used as sentinels according to the provisions of the competent authority; (b) the keeping of poultry in the open air, unless: (i) the poultry are protected against contact with wild birds with nets, roofs, horizontal fabrics or by other appropriate means to prevent contact; or (ii) the poultry are supplied with feed and water indoors or under a shelter which sufficiently discourages the access of wild birds and thereby prevents contact by wild birds with the feed or water intended for the poultry; (c) the use of outdoor water reservoirs for poultry; unless required for animal welfare reasons for certain poultry and they are sufficiently screened against wild birds; (d) the provision of water to poultry from surface water reservoirs that can be accessed by wild birds; unless the water undergoes treatment that ensures the inactivation of avian influenza viruses; (e) the gathering of poultry and other captive birds at markets, shows, exhibitions and cultural events; unless such events are organised and managed in such a way that the risk of virus spread by possibly infected birds to other birds is reduced to a minimum; (f) the use of decoy birds of the orders Anseriformes and Charadriiformes; unless they are used in the framework of a surveillance programme for avian influenza carried out in accordance with Article 4 of Directive 2005/94/EC, research projects, ornithological studies or any other activity permitted by the competent authority; (g) the release of poultry for restocking supplies of game birds; unless authorised by the competent authorities under the condition that: (i) these activities are separated from other holdings; and (ii) the poultry for restocking have been tested virologically in accordance with point 4(a) of Chapter IV of the diagnostic manual for avian influenza set out in the Annex to Commission Decision 2006/437/EC (6) with negative results for avian influenza on samples taken from each production unit within 48 hours before their release. 5. Member States may, on the basis of the regular review of the measures in accordance with Article 5, extend or limit the scope and the period of application of the risk mitigation and reinforced biosecurity measures referred to in paragraph 4. 6. Member States shall encourage the poultry sector to support training activities on risk mitigation and reinforced biosecurity measures for poultry owners, to develop holding-specific biosecurity plans and to monitor the application of biosecurity measures.

Article 5 Maintenance and review of risk mitigation and reinforced biosecurity measures applied in high risk areas 1. Member States shall maintain the measures applied pursuant to Article 4(4) in the high risk areas for the time period during which the heightened risk for HPAI virus introduction and spread persists on their territory. 2. Member States shall regularly review the measures they have taken pursuant to Article 4(4) in order to adjust and adapt them to the prevailing epidemiological situation, in particular as regards the risks posed by wild birds. 3. Member States shall base the review referred to in paragraph 2 on the assessment of the following factors: (a) the development of the disease situation in wild birds, the epidemiological curve, namely, the number of new infections per time unit, the mapping of positive and negative findings and the dynamics of infection; (b) the presence of species of migratory and sedentary wild birds, in particular those identified as target species for avian influenza surveillance; (c) the occurrence of HPAI outbreaks in poultry and other captive birds, in particular as a consequence of primary virus introduction from wild birds; (d) the detection of HPAI in poultry, other captive birds and wild birds during ongoing surveillance; (e) the HPAI virus subtype or subtypes, virus evolution and the potential relevance to human health; (f) the epidemiological situation for HPAI in wild birds, poultry and other captive birds on the territory of nearby Member States and third countries and risk assessments performed by EFSA, national and international risk assessment bodies; (g) the level of implementation and efficiency of the measures laid down in this Decision.

Article 6 Awareness raising Member States shall ensure that the necessary measures are in place to raise awareness among stakeholders active in the poultry sector including small-size holdings of the risks for HPAI virus introduction into holdings and to provide them with the most appropriate information on risk mitigation and reinforced biosecurity measures as provided for in Article 4, in particular the measures to be enforced in high risk areas, by the means best suited to bring such information to their attention. Member States shall also raise awareness of groups involved in wildlife activities including ornithologists, bird watchers and hunters.

Article 7 Early detection systems in poultry flocks 1. Member States shall introduce or reinforce existing early detection systems aimed at rapid reporting by the owners to the competent authority of any sign of HPAI virus presence in flocks of poultry kept on holdings located in high risk areas. 2. The systems referred to in paragraph 1 shall, at least, consider as relevant parameters that indicate the likely presence of disease, a significant drop in feed and water intake and in egg production, the observed mortality rate and any clinical sign or post-mortem lesion suggesting HPAI virus presence taking into account a variation of these parameters in different poultry species and production types.

Article 8 Increased surveillance in wild birds 1. Member States shall ensure that increased surveillance of wild bird populations and further monitoring for dead or sick birds is carried out in accordance with the guidelines on the implementation of surveillance programmes for avian influenza in wild birds set out in Annex II to Commission Decision 2010/367/EU (7) adopted in accordance with Article 4(2) of Directive 2005/94/EC. 2. Member States may target sampling and laboratory testing of wild birds on species and geographical areas previously unaffected by HPAI.

Article 9 Additional temporary measures in the event of confirmation of cases of HPAI in wild birds 1. Where the presence of the HPAI virus is confirmed in samples taken from one or more wild birds or their faeces and where an increased risk for virus introduction into holdings or a possible risk for public health has been identified, Member States shall take additional temporary measures in the vicinity of that finding, which shall include: (a) the implementation of risk mitigation and reinforced biosecurity measures in accordance with Article 4; (b) increased surveillance in wild birds in accordance with Article 8; (c) if necessary, epidemiological investigations and visits to holdings including as appropriate, sampling and testing for HPAI; (d) the introduction and reinforcement of early detection systems in accordance with Article 7. 2. Member States may limit the application of some of the measures referred to in paragraph 1, if the risk of the introduction of the HPAI virus is deemed by the competent authority to be negligible for certain parts of the their territory or certain types of holdings.

Article 10 Compliance and information obligations 1. Member States shall arrange for the monitoring of the implementation by owners and the poultry sector of the measures laid down in this Decision. 2. Member States shall inform the Commission and the other Member States in the framework of the Standing Committee on Plants, Animals, Food and Feed about the measures that they take to comply with this Decision.

Article 11 Addressees This Decision is addressed to the Member States.

Done at Brussels, 10 August 2018. For the Commission Vytenis ANDRIUKAITIS Member of the Commission

(1) OJ L 10, 14.1.2006, p. 16.

(2) EFSA Journal 2017;15(10):4991.

(3) EFSA Journal 2017;15(12):5141.

(4) EFSA Journal 2018;16(3):5240.

(5) Commission Implementing Decision (EU) 2017/263 of 14 February 2017 on risk mitigating and reinforced biosecurity measures and early detection systems in relation to the risks posed by wild birds for the transmission of highly pathogenic avian influenza viruses to poultry (OJ L 39, 16.2.2017, p. 6).

(6) Commission Decision 2006/437/EC of 4 August 2006 approving a Diagnostic Manual for avian influenza as provided for in Council Directive 2005/94/EC (OJ L 237, 31.8.2006, p. 1).

(7) Commission Decision 2010/367/EU of 25 June 2010 on the implementation by Member States of surveillance programmes for avian influenza in poultry and wild birds (OJ L 166, 1.7.2010, p. 22).