COMMISSION REGULATION (EC) No 616/2009
of 13 July 2009
implementing Council Directive 2005/94/EC as regards the approval of poultry compartments and other captive birds compartments with respect to avian influenza and additional preventive biosecurity measures in such compartments
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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 Articles 34(4) and 63(1) thereof,
Whereas:
(1)
In 2004, the World Organisation for Animal Health (OIE) introduced the concept of compartmentalisation in the chapter on zoning and regionalisation of its Terrestrial Animal Health Code (2) (the Code).
(2)
The Code describes in Chapter 4.3 zoning and compartmentalisation as ‘procedures implemented by a country under the provisions of this chapter with a view to defining subpopulations of distinct health status within its territory for the purpose of disease control and/or international trade.’ Although spatial considerations and good management play important roles in the application of both concepts, zoning applies to an animal subpopulation defined primarily on a geographical basis (using natural, artificial or legal boundaries), whereas compartmentalisation applies to an animal subpopulation defined primarily by management and husbandry practices related to biosecurity.
(3)
In addition, Chapter 4.4 on the application of compartmentalisation provides a structured framework for the application and recognition of compartments within countries. A compartment may consist of several establishments and can be approved for a defined animal disease(s), based upon a detailed and documented biosecurity plan drawn up and implemented for the disease(s) concerned. The initial approval of a compartment should preferably take place in a disease-free country, territory or zone, before an outbreak of the specific disease(s) occurs. This is particularly important in the case of highly contagious diseases, such as highly pathogenic avian influenza. In the event of an outbreak, compartmentalisation may be used to facilitate trade.
(4)
The Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions on A new Animal Health Strategy for the European Union (2007 to 2013) where ‘Prevention is better than cure’ (3) (the new animal health strategy) provides direction for the development of an animal health policy for the period from 2007 to 2013. The new animal health strategy aims to put greater focus on precautionary measures, disease surveillance, controls and research, in order to reduce the incidence of animal disease and minimise the impact of outbreaks when they do occur.
(5)
Biosecurity plays an important role in the new animal health strategy. In addition, compartmentalisation would encourage farmers in the Community to apply bio-security measures as compartmentalisation would facilitate safe trade and so present clear advantages for farmers while at the same time prevent animal diseases.
(6)
In that respect, this Regulation should lay down rules for the approval, suspension and withdrawal of approval of compartments in respect of avian influenza. Such rules should take the Code into account in the interests of a consistent approach to combating the spread of avian influenza while considering the distinct health status of approved compartments.
(7)
Directive 2005/94/EC sets out certain preventive measures relating to the surveillance and the early detection of avian influenza and the minimum control measures and movement restrictions to be applied in the event of an outbreak of that disease in poultry or other captive birds. Certain of those measures are to be applied in poultry compartments or in other captive bird compartments, as defined in that Directive.
(8)
Directive 2005/94/EC provides a definition of poultry compartments and other captive birds' compartments and also provides that additional biosecurity measures may be applied in those compartments in order to prevent the spread of avian influenza.
(9)
Directive 2005/94/EC provides that Member States are to carry out surveillance programmes in order to detect the prevalence of infections with avian influenza virus subtypes H5 and H7 in different species of poultry. For that purpose, compulsory surveillance programmes for avian influenza are annually approved in Member States. The approval of compartments in a Member State should therefore be subject to the approval of the national surveillance programme of the concerned Member State.
(10)
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 (4), lays down diagnostic procedures, sampling methods and criteria for the evaluation of the results of laboratory tests for the confirmation of an outbreak of avian influenza. In the interests of consistency of Community legislation in this area, those procedures and methods should be followed in the framework of a compartment.
(11)
In order to facilitate the use of procedures by electronic means between Member States, and to ensure transparency and comprehensibility, it is important that information on the approved compartments, and on any granting, suspension or withdrawal of approval is made available in the most efficient way throughout the Community. The Member States should therefore establish Internet-based information pages containing such information and the Commission's website should display links to those pages.
(12)
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS REGULATION:
CHAPTER I
SUBJECT MATTER, SCOPE AND DEFINITIONS
Article 1
Subject matter and scope
This Regulation lays down rules for approval by the Member States of poultry compartments, and other captive birds compartments, in relation to avian influenza (hereinafter referred to as compartments), and provides for additional preventive biosecurity measures to be implemented in such compartments to grant them a distinct health status in relation to avian influenza.
Article 2
Definitions
For the purposes of this Regulation, the following definitions apply:
1.
‘biosecurity plan’ means all the biosecurity measures being implemented at holding level;
2.
‘common biosecurity management system’ means:
(a)
the common rules governing the functioning of a compartment; and
(b)
the overall biosecurity measures implemented in all the holdings comprising the compartment in accordance with their biosecurity plans;
3.
‘compartment manager’ means the person formally responsible for the compartment, in particular in relation to Articles 3, 4 and 5, and including:
(a)
supervising all actions carried out in the compartment relating to the common biosecurity management system, in particular for the implementation and monitoring of that system;
(b)
supervising the implementation of the holdings' biosecurity plans by the poultry or other captive birds' owners or keepers; and
(c)
liaising with the competent authority;
4.
‘exit holding’ means a holding from which poultry or other captive birds or their day-old chicks or hatching or table eggs (hereafter referred to as ‘commodities’), are destined to be moved outside of the compartment;
5.
‘supplier holding’ means a holding from which the commodities are destined for an exit holding or any other holding within a compartment;
6.
‘all involved parties’ means compartment managers, business operators including food and feed business operators as defined in Article 3(3) and (6) of Regulation (EC) No 178/2002 of the European Parliament and of the Council (5), animal owners and keepers, pharmaceutical producers, or other industries delivering commodities to, or providing services for, the compartment.
CHAPTER II
APPROVAL OF COMPARTMENTS
Article 3
Applications for the approval of compartments
1. Voluntary applications for the approval of compartments (hereinafter referred to as applications) shall be submitted to the competent authority by the compartment manager.
2. The application shall contain the following information:
(a)
the name of the compartment manager, his or her qualifications and position, contact details and the address of the compartment;
(b)
a detailed description of the compartment, as set out in Part 1 of the Annex;
(c)
a description of the common biosecurity management system and of the biosecurity plans of the holdings comprising the compartment, as set out in Part 2 of the Annex;
(d)
detailed information on the specific measures, criteria and requirements for disease surveillance, in particular specific protection and surveillance for avian influenza, as set out in Part 3 of the Annex.
Article 4
Granting approval of compartments
1. The initial approval of a compartment shall only be granted by the competent authority for compartments which are situated in the territory, or part of the territory of a Member State, where no restrictions apply in relation to avian influenza, pursuant to Community legislation.
The initial approval of a compartment shall only be granted in a Member State whose national surveillance programme in order to detect the prevalence of infections with avian influenza virus subtypes H5 and H7 in different species of poultry, has been approved.
2. Before granting approval for a compartment, the competent authority shall ensure that in the compartment:
(a)
specific protection and surveillance for avian influenza has been carried out for a period of at least six months prior to the date of application, as required by Part 3 of the Annex (including at least one testing procedure as required in point 4 of Part 3 of the Annex), and the presence of avian influenza has not been detected in any of the holdings comprising the compartment during that period;
(b)
where appropriate, vaccination plans are carried out in accordance with Community legislation;
(c)
the information submitted in accordance with Article 3(2) is complete and accurate;
(d)
a common biosecurity management system, as set out in point 1 of Part 2 of the Annex, has been implemented and has shown to be sufficient to ensure a distinct health status with respect to avian influenza for the poultry or other captive birds population of the compartment;
(e)
an official on-site control has been carried out with favourable results with respect to points (a) to (d);
3. The compartment shall have only one name and be granted only one approval number.
4. The competent authority shall ensure that following the granting of approval of a compartment, it is listed without delay on the list of approved compartments on the Internet-based information page provided for in Article 9(1) with detailed information concerning the location of the holdings comprising the compartment and whether they are exit or supplier holdings (list of approved compartments).
CHAPTER III
CONDITIONS FOR THE RETENTION OF APPROVAL OF COMPARTMENTS
Article 5
Responsibilities and duties of the compartment manager
Following the grant of approval of a compartment, the compartment manager shall:
1.
supervise and monitor the compartment in order to ensure that it continues to comply with the information submitted in accordance with Article 3(2) and the criteria and requirements set out in the Annex; in particular such information must be kept up-to-date and made available to the competent authority on request;
2.
ensure that disease surveillance activities, in particular surveillance for avian influenza, are carried out according to the common biosecurity management system and each biosecurity plan of the holdings comprising the compartment and that:
(a)
an early warning system is in place for the detection of the presence of avian influenza; and sampling and diagnostic tests are carried out in accordance with Decision 2006/437/EC and Part 3 of the Annex to this Regulation;
(b)
surveillance plans as set in point 4 of Part 3 of the Annex are updated in the case of the identification of an increased risk of the introduction of avian influenza;
(c)
all avian influenza diagnostic tests are carried out in laboratories officially approved for that purpose by the competent authority; information on the surveillance and results are made available to the competent authority;
(d)
any inconclusive or positive results of the surveillance in the compartment are immediately reported to the competent authority, so that the related samples can be sent for confirmation to the national reference laboratory or Community reference laboratory for avian influenza;
3.
ensure that any vaccination applied is carried out according to the common biosecurity management system and each biosecurity plan of the holdings comprising the compartment and that vaccination plans and procedures are made available to the competent authority on request;
4.
organise regular internal or external audits to guarantee that all biosecurity measures, surveillance activities and the traceability system are effectively implemented in the compartment and keep the results of such audits, including those carried out in the framework of a quality assurance system, so that they are available to the competent authority on request;
5.
immediately inform the competent authority if:
(a)
the compartment no longer complies with the information submitted in accordance with Article 3(2) or the criteria and requirements set out in the Annex;
(b)
the common biosecurity management system or a biosecurity plan has been amended or adapted to the epidemiological situation, including when a holding is added or withdrawn from the compartment.
Article 6
Responsibilities and duties of the competent authority
1. The competent authority shall ensure that official on-site risk-based controls of compartments are carried out in order to verify whether they continue to comply with the information submitted in accordance with Article 3(2) and the criteria and requirements set out in the Annex (controls).
2. Controls shall be carried out at intervals based on:
(a)
the epidemiological situation inside and outside of the compartment, in particular in relation to avian influenza;
(b)
information concerning any amendments or adaptations to the common biosecurity management system or biosecurity plans of the holdings comprising the compartment, as provided for in Article 5(5)(b).
3. The competent authority shall be responsible for any certification attesting that commodities come from an approved compartment.
CHAPTER IV
SUSPENSION OR WITHDRAWAL OF APPROVAL OF COMPARTMENTS
Article 7
Suspension of approval of compartments
1. If a control, or the epidemiological information related to the compartment shows that it no longer complies with the information submitted in accordance with Article 3(2), or the criteria and requirements set out in the Annex, the competent authority shall immediately suspend the approval of the compartment concerned and the compartment manager shall ensure that immediate action is taken to correct any such non-compliance.
2. Following the suspension of the approval of a compartment, the competent authority shall suspend any certification attesting that the commodities come from an approved compartment.
3. Where the approval of a compartment has been suspended, the competent authority shall not lift the suspension until it has verified that corrective action has been launched within 30 days of the date of the suspension and a subsequent control has been carried out with favourable results.
Article 8
Withdrawal of approval of compartments
1. The competent authority shall withdraw the approval of a compartment where, following suspension of the compartment in accordance with Article 7(1), the subsequent control in accordance with Article 7(3) demonstrates that:
(a)
the compartment continues not to comply with the information submitted in accordance with Article 3(2) or the criteria and requirements set out in the Annex; or
(b)
an outbreak of avian influenza occurred in the compartment.
2. Following the withdrawal of an approval of a compartment, the competent authority shall:
(a)
stop any certification attesting that commodities come from an approved compartment;
(b)
delete the name of the compartment from the list of approved compartments.
3. Following the deletion of the name of a compartment from the list of approved compartments, it may only be restored following a new application in accordance with Chapter II.
CHAPTER V
INTERNET-BASED INFORMATION PAGE AND FINAL PROVISIONS
Article 9
Internet-based information page
1. Member States shall:
(a)
establish a list of approved compartments with the information required by Article 4(3) and (4);
(b)
establish an Internet-based information page to make the list of approved compartments electronically available;
(c)
communicate the Internet address of the Internet-based information pages to the Commission;
(d)
keep their Internet-based information page updated to take into account without delay any new approvals or withdrawals of approval of compartments;
2. The Commission shall assist the Member States in making such information available to the public by providing the Internet address of its website which shall display national links to Internet-based information pages.
Article 10
Entry into force
This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
It shall apply from 1 October 2009.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 13 July 2009.