http://www.legislation.gov.uk/id/eudn/2015/2444

Commission Implementing Decision (EU) 2015/2444

of 17 December 2015

laying down standard requirements for the submission by Member States of national programmes for the eradication, control and surveillance of animal diseases and zoonoses for Union financing and repealing Decision 2008/425/EC

(notified under document C(2015) 9192)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

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

Having regard to Regulation (EU) No 652/2014 of the European Parliament and of the Council of 15 May 2014 laying down provisions for the management of expenditure relating to the food chain, animal health and animal welfare, and relating to plant health and plant reproductive material, amending Council Directives 98/56/EC, 2000/29/EC and 2008/90/EC, Regulations (EC) No 178/2002, (EC) No 882/2004 and (EC) No 396/2005 of the European Parliament and of the Council, Directive 2009/128/EC of the European Parliament and of the Council and Regulation (EC) No 1107/2009 of the European Parliament and of the Council and repealing Council Decisions 66/399/EEC, 76/894/EEC and 2009/470/EC1, and in particular Article 36(5) thereof.

Whereas:

(1)

Regulation (EU) No 652/2014 lays down, inter alia, provisions for the management of expenditure relating to the food chain and animal health and requirements for the submission and the content of the national programmes for the eradication, control and surveillance of animal diseases and zoonoses.

(2)

Article 12(1) of Regulation (EU) No 652/2014 provides that each year, by 31 May at the latest, Member States are to submit to the Commission the national programmes starting in the following year for which they wish to apply for a grant.

(3)

Commission Decision 2008/425/EC2 provides that Member States seeking a financial contribution from the Union for national programmes for the eradication, monitoring and control of certain animal diseases are to submit applications containing certain minimum information set out in Annexes I to V to that Decision.

(4)

Following the adoption of Regulation (EU) No 652/2014, standard requirements for the content and the submission by Member States of national programmes as defined in Article 9 of that Regulation should be revised to fully comply with the requirements of Article 12 of that Regulation.

(5)

In addition, the standard requirements for the content and submission by Member States of national programmes as defined in Article 9 of Regulation (EU) No 652/2014, should comply with the criteria for national eradication, control and monitoring programmes established by Commission Decision 2008/341/EC3.

(6)

To be in line with evolving Union legislation, the electronic standard templates provided online on the Commission's website should be used for certain diseases to facilitate necessary modifications or including further details. The Commission will inform and discuss with Member States all necessary modifications of the electronic standard templates in the framework of the Standing Committee on Plants, Animals, Food and Feed. The revised electronic standard templates will be sent to all Member States at the latest by early March of the concerned year.

(7)

For other diseases not included in electronic standard templates and for aquaculture diseases the use of non-electronic standard templates is considered the appropriate tool for submissions of national programmes, given the low number of submissions in the last years, which does not justify the development of specific electronic templates.

(8)

For the sake of clarity, Decision 2008/425/EC should therefore be repealed and replaced by this Decision.

(9)

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

In addition to the content set out in Article 12(2) of Regulation (EU) No 652/2014, national programmes shall contain the information provided in the Annexes to this Decision.

Article 2

National programmes laid down in Article 9 of Regulation (EU) No 652/2014 shall be submitted on-line by using the corresponding standard electronic templates indicated in Annexes I to IV to this Decision or by mail by using the corresponding standard templates set out in Annex V to this Decision for diseases not included in the electronic templates and in Annex VI to this Decision for aquaculture diseases

Article 3

Decision 2008/425/EC is repealed.

Article 4

This Decision shall apply to submissions of national eradication, control and surveillance programmes for 2017 and following years

Article 5

This Decision is addressed to the Member States.

Done at Brussels, 17 December 2015.

For the Commission

Vytenis Andriukaitis

Member of the Commission

ANNEX I

The specific pdf template to be used to submit the national programmes on the animal diseases listed below, are available on DG SANTE web:

http://ec.europa.eu/dgs/health_food-safety/funding/cff/animal_health/vet_progs_en.htm

Annex I.a: in respect of rabies

Annex I.b: in respect of bovine tuberculosis, bovine brucellosis and ovine and caprine brucellosis (B. melitensis)

Annex I.c: in respect of classical swine fever, african swine fever and swine vesicular disease

Annex I.d: in respect of bluetongue.

ANNEX II

The specific pdf template to be used to submit the Salmonella control programmes, is available on DG SANTE web:

http://ec.europa.eu/dgs/health_food-safety/funding/cff/animal_health/vet_progs_en.htm

ANNEX III

The specific pdf template to be used to submit Transmissible Spongiform Encephalopathies (BSE and scrapie) control programmes, is available on DG SANTE web:

http://ec.europa.eu/dgs/health_food-safety/funding/cff/animal_health/vet_progs_en.htm

ANNEX IV

The specific pdf template to be used to submit Avian Influenza surveillance programmes, is available on DG SANTE web:

http://ec.europa.eu/dgs/health_food-safety/funding/cff/animal_health/vet_progs_en.htm

ANNEX V

Standard requirements for the submission of national programmes for the eradication, control or surveillance of the animal diseases listed below:

Anthrax
Contagious bovine pleuropneumonia
Echinococcosis
Campylobacteriosis
Listeriosis
Trichinellosis
Verotoxigenic E. coli

1.Identification of the programme

Member State:

Disease(s)4:

Duration of the programme: annual/multiannual

Request for Union co-financing for5:

Reference of this document:

Contact (name, phone, fax, e-mail):

Date of submission to the Commission:

2.Description of the epidemiological situation of the disease/zoonoses before the date of the beginning of the implementation of the programme and data on the epidemiological evolution of the disease(s)6:

3.Description of the submitted programme7:

4.Measures of the submitted programme to be implemented

4.1.

Summary of measures under the programme:

4.2.

Organisation, supervision and role of all stakeholders8involved in the programme:

4.3.

Description and demarcation of the geographical and administrative areas in which the programme is to be implemented9:

4.4.

The targets to be attained by the completion date of the programme and the anticipated benefits thereof:

4.5.

Appropriate indicators to measure the achievement of the targets of the programme:

4.6.

Description of the measures of the programme10:

4.6.1.
Notification of the disease
4.6.2.
Target animals and animal population
4.6.3.
Identification of animals and registration of holdings
4.6.4.
Qualifications of animals and herds11
4.6.5.
Rules on the movement of animals
4.6.6.
Tests used and sampling schemes
4.6.7.
Vaccines used and vaccination schemes
4.6.8.
Information and assessment on bio-security measures management and infrastructure in place in the holdings involved
4.6.9.
Measures in case of a positive result12
4.6.10.
Compensation scheme for owners of slaughtered and killed animals13
4.6.11.
Control on the implementation of the programme and reporting14

5.Financial resources for the implementation of the programme:

Estimated budget and the source: public/private or both.

6.Data on the epidemiological evolution during the last five years15

6.1.Evolution of the disease

6.1.1.Data on herds16 (one table per year)

Regio17	Animal species	Total number of herds18	Total number of herds under the programme	Number of herds checked19	Number of positive herds20	Number of new positive herds21	Number of herds depopulated	% positive herds depopulated	INDICATORS
Year:
Regio17	Animal species	Total number of herds18	Total number of herds under the programme	Number of herds checked19	Number of positive herds20	Number of new positive herds21	Number of herds depopulated	% positive herds depopulated	% herd coverage	% positive herdsPeriod herd prevalence	% new positive herdsHerd incidence
1	2	3	4	5	6	7	8	9 = (/) × 100	10 = (5/4) × 100	11 = (6/5) × 100	12 = (7/5) × 100




Total
Herds or flocks or holdings as appropriate.
Region as defined in the programme of the Member State.
Total number of herds existing in the region including eligible herds and non-eligible herds for the programme.
Check means to perform a herd level test under the programme for the respective disease with the purpose of maintaining or upgrading, the health status of the herd. In this column a herd must not be counted twice even if has been checked more than once.
Herds with at least one positive animal during the period independent of the number of times the herd has been checked.
Herds which status in the previous period was Unknown, Not free-negative, Free, Officially Free or Suspended and have at least one animal tested positive in this period.

6.1.2.Data on animals (one table per year)

Region22	Animal species	Total number of animals23	Number of animals25 to be tested under the programme	Number of animals24 tested	Number of animals tested individually25	Number of positive animals	Slaughtering		INDICATORS
Year:
Region22	Animal species	Total number of animals23	Number of animals25 to be tested under the programme	Number of animals24 tested	Number of animals tested individually25	Number of positive animals	Number of animals with positive result slaughtered or culled	Total number of animals slaughtered26	% coverage at animal level	% positive animalsAnimal prevalence
1	2	3	4	5	6	7	8	9	10 = (5/4) × 100	11 = (7/5) × 100






Total
Region as defined in the programme of the Member State.
Total number of animals existing in the region including eligible herds and non-eligible herds for the programme.
Includes animals tested individually or under bulk level scheme.
Include only animals tested individually, do not include animals tested by bulk level samples.
Include all positive animal slaughtered and also the negative animals slaughtered under the programme.

6.2.Stratified data on surveillance and laboratory tests

6.2.1.Stratified data on surveillance and laboratory tests

Region27	Animal species/category	Test type28	Test description	Number of samples tested	Number of positive samples
Year:





Total
Region as defined in the programme of the Member State.
Indicate whether the test is serological, virological, etc.

6.3.Data on infection (one table per year)

Region29	Animal species	Number of herds infected30	Number of animals infected
Year:










Total
Region as defined in the programme of the Member State.
Herds or flocks or holdings as appropriate.

6.4.Data on the status of herds at the end of each year (if applicable)

Region31	Status of herds and animals under the programme32
Year:
	Total number of herds and animals under the programme		Unknown33		Not free or not officially free from disease				Free or officially free from disease status suspended36		Free from disease37		Officially free from disease38
	Total number of herds and animals under the programme		Unknown33		Last check positive34		Last check negative35		Free or officially free from disease status suspended36		Free from disease37		Officially free from disease38
	Herds	Animals39	Herds	Animals39	Herds	Animals39	Herds	Animals39	Herds	Animals39	Herds	Animals39	Herds	Animals39






Total
Region as defined in the programme of the Member State.
At the end of the year.
Unknown: No previous checking results available.
Not free and last check positive: Herd checked with at least one positive result in the latest check.
Not free and last check negative: Herd checked with negative results in the latest check but not being Free or Officially Free.
Suspended as defined in Union or national legislation for the respective disease at the end of the reporting period.
Free herd as defined in Union or national legislation for the respective disease.
Officially free herd as defined in Union or national legislation for the respective disease.
Include animals under the programme in the herds with the referred status (left column).

6.5.Data on vaccination or treatment programmes40

Region41	Animal species	Total number of herds42	Total number of animals	Information on vaccination or treatment programme
Year:
Region41	Animal species	Total number of herds42	Total number of animals	Number of herds in vaccination or treatment programme	Number of herds vaccinated or treated	Number of animals vaccinated or treated	Number of doses of vaccine or treatment administered	Number of adults vaccinated	Number of young animals vaccinated






Total
Region as defined in the programme of the Member State.
Herds or flocks or holdings as appropriate.

6.6.Data on wildlife43

6.6.1.Estimation of wildlife population

Regions44	Animal species	Method of estimation	Estimated population
Year:






Total
Region as defined in the programme of the Member State.

6.6.2.Disease surveillance and other tests in wildlife (one table per year)

Region45	Animal Species	Test type46	Test description	Number of samples tested	Number of positive samples
Year:






Total
Region as defined in the programme of the Member State.
Indicate whether the test is serological, virological, biomarker detection etc.

6.6.3.Data on vaccination or treatment of wildlife

Region47	Square km	Vaccination or treatment programme
Year:
Region47	Square km	Number of doses of vaccine or treatment to be administered	Number of campaigns	Total number of doses of vaccine or treatment administered







Total
Region as defined in the programme of the Member State.

7.Targets

7.1.Targets related to testing (one table for each year of implementation48)

7.1.1.Targets on diagnostic tests

Region49	Test type50	Target population51	Type of sample52	Objective53	Number of planned tests






Total
Region as defined in the programme of the Member State.
Description of the test.
Specification of the targeted species and the categories of targeted animals.
Description of the sample.
Description of the objective (for instance qualification, surveillance, confirmation of suspected cases, monitoring of campaigns, sero-conversion, control on deleted vaccines, testing of vaccine, control of vaccination, etc.).

7.1.2.Targets on testing herds and animals

7.1.2.1.Targets on the testing of herds54

Region55	Animal species	Total number of herds56	Total number of herds under the programme	Number of herds expected to be checked57	Number of expected positive herds58	Number of expected new positive herds59	Number of herds expected to be depopulated	% positive herds expected to be depopulated	TARGET INDICATORS
Region55	Animal species	Total number of herds56	Total number of herds under the programme	Number of herds expected to be checked57	Number of expected positive herds58	Number of expected new positive herds59	Number of herds expected to be depopulated	% positive herds expected to be depopulated	Expected % herd coverage	% positive herdsExpected period herd prevalence	% new positive herdsExpected herd incidence
1	2	3	4	5	6	7	8	9 = (8/6) × 100	10 = (5/4) × 100	11 = (6/5) × 100	12 = (7/5) × 100





Total
Herds or flocks, or holdings as appropriate.
Region as defined in the programme of the Member State.
Total number of herds existing in the region including eligible herds and non-eligible herds for the programme.
Check means to perform a herd level test under the programme for the respective disease with the purpose of maintaining, upgrading, etc., the health status of the herd. In this column a herd must not be counted twice even if it has been checked more than once.
Herds with at least one positive animal during the period independent of the number of times the herd has been checked.
Herds which status in the previous period was Unknown, Not free-negative, Free, Officially Free or Suspended and have at least one positive animal in this period.

7.1.2.2.Targets on the testing of animals

Region60	Animal species	Total number of animals61	Number of animals62 under the programme	Number of animals62 expected to be tested	Number of animals to be tested individually63	Number of expected positive animals	Slaughtering		TARGET INDICATORS
Region60	Animal species	Total number of animals61	Number of animals62 under the programme	Number of animals62 expected to be tested	Number of animals to be tested individually63	Number of expected positive animals	Number of animals tested positive expected to be slaughtered or culled	Total number of animals expected to be slaughtered64	Expected % coverage at animal level	% positive animals (Expected animal prevalence)
1	2	3	4	5	6	7	8	9	10 = (5/4) × 100	11 = (7/5) × 100








Region as defined in the programme of the Member State.
Total number of animals existing in the region including eligible herds and non-eligible herds for the programme.
Includes animals tested individually or under bulk level scheme.
Include only animals tested individually, do not include animals tested by bulk level samples.
Include all positive animals slaughtered and also the negative animals slaughtered under the programme.

7.2.Targets on qualification of herds and animals (one table for each year of implementation) if applicable.

Region65	Total number of herds and animals under the programme		Targets on the status of herds and animals under the programme66
			Expected unknown67		Expected not free or not officially free from disease				Expected free or officially free from disease status suspended70		Expected free from disease71		Expected officially free from disease72
			Expected unknown67		Last check positive68		Last check negative69				Expected free from disease71		Expected officially free from disease72
	Herds	Animals73	Herds	Animals73	Herds	Animals73	Herds	Animals73	Herds	Animals73	Herds	Animals73	Herds	Animals73






Total
Region as defined in the programme of the Member State.
At the end of the year.
Unknown: No previous checking results available.
Not free and last check positive: Herd checked with at least one positive result in the latest check.
Not free and last check negative: Herd checked with negative results in the latest check but not being Free or Officially Free.
Suspended as defined for the respective disease in Union or national legislation where appropriate or according national legislation.
Free herd as defined for the respective disease where appropriate in Union or national legislation where appropriate or according to national legislation.
Officially free herd as defined for the respective disease where appropriate in Union or national legislation or according to national legislation.
Include animals under the programme in the herds with the referred status (left column).

7.3.Targets on vaccination or treatment (one table for each year of implementation)

7.3.1.Targets on vaccination or treatment74

Region75	Animal species	Targets on vaccination or treatment programme
Region75	Animal species	Number of herds76 in vaccination or treatment programme	Number of herds76 expected to be vaccinated or treated	Number of animals expected to be vaccinated or treated	Number of doses of vaccine or treatment expected to be administered	Number of adults expected to be vaccinated	Number of young animals expected to be vaccinated






Total
Region as defined in the programme of the Member State.
Herds or flocks or holdings as appropriate.

7.3.2.Targets on vaccination or treatment77 of wildlife

Region78	Animal species	Square km	Targets on the vaccination or treatment programme
Region78	Animal species	Square km	Number of doses of vaccine or treatments expected to be administered in the campaign	Expected number of campaigns	Total number of doses of vaccine or treatment expected to be administered







Total
Region as defined in the programme of the Member State.

8.Detailed analysis of the cost of the programme (one table per year of implementation)

Costs related to	Specification	Number of units	Unitary cost in EUR	Total amount in EUR	Union funding requested (yes/no)
1. Testing
1.1. Cost of the sampling
	Domestic animals

1.2. Cost of the analysis	Bacteriological tests (cultivation) in the framework of official sampling
	Serotyping of relevant isolates
	Bacteriological test to verify the efficiency of disinfection of premises after depopulation of a salmonella-positive flock
	Test for the detection of antimicrobials or bacterial growth inhibitory effect in tissues from animals from flocks/herds tested for salmonella
	Other (please specify)

2. Vaccination	(If co-financing for the purchase of vaccines is requested, Sections 6.4 and 7.2 must also be completed if vaccination policy is part of your programme)
2.1. Purchase of vaccine doses	Number of vaccine doses





3. Slaughter and destruction
3.1. Compensation of animals	Compensation of animals

3.2. Transport costs

3.3. Destruction costs

3.4. Loss in case of slaughtering

3.5. Costs from treatment of animal products (eggs, hatching eggs, etc.)	Costs from treatment of animal products (eggs, hatching eggs, etc.

4. Cleaning and disinfection


5. Salaries (staff contracted for the programme only)	Salaries
	Other (please specify)

6. Consumables and specific equipment


7. Other costs



Total

ANNEX VI

Standard requirements for the submission of national programmes for the eradication of the aquacultures animal diseases listed below:

Viral haemorrhagic septicæmia (VHS)
Infectious haematopoietic necrosis (IHN)
Koi herpes virus disease (KHV)
Infectious salmon anaemia (ISA)
Infection with Marteilia refringens
Infection with Bonamia ostreae
White spot disease in crustaceans

Requirements/information needed		Information/further explanation and justification
1.	Identification of the programme
1.1.	Declaring Member State
1.2.	Competent authority (address, fax, e-mail)
1.3.	Reference of this document
1.4.	Date of the submission to the Commission
2.	Type of communication
2.1.	☐ Application for eradication programme
3.	National legislation79
4.	Request for co-financing
4.1.	Indicate the year(s) for which co-financing is requested
4.2.	Agreement of the managing authority of the operational programme (signature and stamp)
5.	Diseases
5.1.	Fish	☐	VHS
		☐	IHN
		☐	ISAV
		☐	KHV
5.2.	Molluscs	☐	Marteilia refringens
5.2.	Molluscs	☐	Bonamia ostrae
5.3.	Crustaceans	☐	White spot disease
6.	General information on the programmes
6.1.	Competent authority80
6.2.	Organisation, supervision of all stakeholders involved in the programme81
6.3.	An overview of the structure of the aquaculture industry in the area in question including types of production, species kept etc.
6.4.	Notification to the competent authority of suspicion and confirmation of the disease(s) in question has been compulsory since when?
6.5.	Early detection system in place throughout the Member States, enabling the competent authority to undertake effective disease investigation and reporting since when?82
6.6.	Source of aquaculture animals of susceptible species to the disease in question entering in the Member State, zone or compartments for farming
6.7.	Guidelines on good hygiene practice83
6.8.	Epidemiological situation of the disease in at least the previous four years before the commencement of the programme84
6.9.	Estimated costs and the anticipated benefits of the programme85
6.10.	Description of the submitted programme86
6.11.	Duration of the programme
7.	Area covered87
7.1.	☐ Member State
7.2.	☐ Zone (entire water catchment area)88
7.3.	☐Zone (part of water catchment area)89 Identify and describe the artificial or natural barrier that delimits the zone and justify its capability to prevent the upward migration of aquatic animals from the lower stretches of the water catchment area.
7.4.	☐ Zone (more than one water catchment area)90
7.5.	☐ Compartment independent on the surrounding health status91
	Identify and describe for each farm the water supply92	☐	Well, borehole or spring
	Identify and describe for each farm the water supply92	☐	Water treatment plant inactivating the relevant pathogen93
	Identify and describe for each farm natural or artificial barriers and justify its capability to prevent that aquatic animals enter each farm in a compartment from the surrounding watercourses.
	Identify and describe for each farm the protection against flooding and infiltration of water from the surrounding area
7.6.	☐ Compartment dependent on the surrounding health status94
	☐ One epidemiological unit due to geographical localisation and distance from other farms/farming areas95
	☐ All farms comprising the compartment fall within a common biosecurity system96
	☐ Any additional requirements97
7.7.	Farms or mollusc farming areas covered by the programme (registration numbers and geographical situation)
8.	Measures of the submitted programme
8.1.	Summary of the measures under the programme
	First year ☐ Testing ☐ Harvesting for human consumption or further processing ☐ Immediate ☐ Delayed ☐ Removal and disposal ☐ Immediate ☐ Delayed ☐ Vaccination ☐ Other measures (specify)	Last year ☐ Testing ☐ Harvesting for human consumption or further processing ☐ Immediate ☐ Delayed ☐ Removal and disposal ☐ Immediate ☐ Delayed ☐ Other measures (specify)
8.2.	Description of the measures of the programme98
	Target population/species
	Used tests and sampling schemes. Laboratories involved in the programme99
	Rules on movements of animals
	Used vaccines and vaccination schemes
	Measures in case of a positive result100
	Compensation scheme for owners
	Control and supervision on the implementation of the programme and reporting
National legislation in force applicable to the application for eradication programme.
A description shall be provided of the structure, competencies, duties and powers of the competent authority or competent authorities involved.
A description shall be provided of the authorities in charge of the supervision and coordination of the programme and the different operators involved.
The early detection systems shall in particular ensure the rapid recognition of any clinical signs consistent with the suspicion of a disease, emerging disease, or unexplained mortality in farms or molluscs farming areas, and in the wild, and the rapid communication of the event to the competent authority with the aim to activating diagnostic investigation with minimum delay. The early detection system shall include at least the following: (a) broad awareness, among the personnel employed in aquaculture businesses or involved in the processing of aquaculture animals, of any signs consistent with the presence of a disease, and training of veterinarians of aquatic animals health specialists in detecting and reporting unusual disease occurrence; (b) veterinarians or aquatic animal health specialists trained in recognising and reporting suspicious disease occurrence; (c) access by the competent authority to laboratories with the facilities for diagnosing and differentiating listed and emerging diseases.
A description shall be provided in accordance with Article 9 of Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (OJ L 328, 24.11.2006, p. 14).
Information shall be given using the table laid down in Part 9 of Annex VI to this Decision.
A description shall be provided of the benefits for farmers and society in general.
A concise description of the programme shall be given with the main objectives, the main measures, the target population, the areas of implementation and the definition of a positive case.
The area covered shall be clearly identified and described in a map, which should be attached as an Annex to the application.
An entire water catchment area from its sources to its estuary.
Part of a water catchment area from the source(s) to a natural or artificial barrier that prevents the upward migration of aquatic animals from the lower stretches of the water catchment area.
More than one water catchment area, including their estuaries, due to the epidemiological link between the catchment areas through the estuary.
Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is independent on the health status regarding that disease of surrounding natural waters.
A compartment which is independent of the health status of surrounding waters, shall be supplied with water: (a) through a water treatment plant inactivating the relevant pathogen in order to reduce the risk of the introduction of the disease to an acceptable level; or (b) directly from a well, a borehole or a spring. Where such water supply is situated outside the premises of the farm, the water shall be supplied directly to the farm, and be channelled through a pipe.
Technical information shall be provided to demonstrate that the relevant pathogen is inactivated in order to reduce the risk of the introduction of the disease to an acceptable level.
Compartments comprising one or more farms or mollusc farming areas where the health status regarding a specific disease is dependent on the health status regarding that disease of surrounding natural waters.
A description shall be provided of the geographical localisation and the distance from other farms/farming areas that make possible to consider the compartment as one epidemiological unit.
A description shall be provided of the common biosecurity system.
Each farm or mollusc farming area in a compartment which is dependent on the health status of surrounding waters shall be subject to additional measures imposed by the competent authority, when considered necessary to prevent the introduction of diseases. Such measures may include the establishment of a buffer zone around the compartment in which a monitoring programme is carried out, and the establishment of additional protection against the intrusion of possible pathogen carriers or vectors.
A comprehensive description needs to be provided unless reference can be made to Union legislation. The national legislation in which the measures are laid down shall be mentioned.
Describe diagnostic methods and sampling schemes. When OIE or Union standards are applied, refer to them. If not, describe them. Name the laboratories involved in the programme (National Reference Laboratory or designated laboratories).
A description is provided of the measures as regards positive animals (immediate or delayed harvesting for human consumption, immediate or delayed removal and disposal, measures to avoid the spread of the pathogen when harvesting, further processing or removal and disposal takes place, a procedure for the disinfection of the infected farms or mollusc farming areas, a procedure for restocking with healthy animals in farms or farming areas which have been depopulated and creation of surveillance zone around the infected farm or farming area, etc.).

9.Data on the epidemiological situation/evolution of the disease in the last four years (one table for each year of implementation)

9.1.Data on testing animals

Member State, zone or compartment101

Disease		Year
Farm or mollusc farming area	Number of samplings	Number of clinical inspections	Water temperature at sampling/inspection	Species at sampling	Species sampled	Number of animals sampled (total and by species)	Number of tests	Positive results of laboratorial examination	Positive results of clinical inspections






Total
Member State, zone or compartment as defined in Point 7 of Annex VI.

9.2.Data on testing farms or farming areas

Disease		Year
Member State, zone or compartment102	Total number of farms or mollusc farming areas103	Total number farms or mollusc farming areas under the programme	Number of farms or mollusc farming areas checked104	Number of positive farms or mollusc farming areas105	Number of new positive farms or mollusc farming areas106	Number of farms or mollusc farming areas depopulated	% positive farms or mollusc farming areas depopulated	Animals removed and disposed of107	Target indicators
Member State, zone or compartment102	Total number of farms or mollusc farming areas103		Number of farms or mollusc farming areas checked104	Number of positive farms or mollusc farming areas105	Number of new positive farms or mollusc farming areas106	Number of farms or mollusc farming areas depopulated	% positive farms or mollusc farming areas depopulated	Animals removed and disposed of107	% farms or mollusc farming areas coverage	% positive farms or mollusc farming areasperiod farms or mollusc farming areas prevalence	% new positive farms or mollusc farming areasfarms or mollusc farming areas incidence
1	2	3	4	5	6	7	8 =	9	10 =	11 = (5/4) × 100	12 = (6/4) × 100






Total
Member State, zone or compartment as defined in Point 7 of Annex VI.
Total number of farms or mollusc farming areas existing in the Member State, zone or compartment as defined in Point 7 of Annex VI.
Check means to perform a farm/mollusc farming area level test under the programme for the respective disease with the purpose of upgrading the health status of the farm/mollusc farming area. In this column a farm/mollusc farming area should not be counted twice even if has been checked more than once.
Farms or mollusc farming areas with at least one positive animal during the period independent of the number of times the farms or mollusc farming areas has been checked.
Farms or mollusc farming areas which health status in the previous period was, in accordance with Part A of Annex III to Directive 2006/88/EC, category I, category II, category III or category IV and have at least one positive animal in this period.
Animals × 1 000 or total weight of animals removed and disposed of.

10.Targets (one table for each year of implementation)

10.1.Targets related to testing animals

Member State, zone or compartment108

Disease		Year
Farm or mollusc farming area	Number of samplings	Number of clinical inspections	Water temperature at sampling/Inspection	Species at sampling	Species sampled	Number of animals sampled (total and by species)	Number of tests






Total
Member State, zone or compartment as defined in Point 7 of Annex VI.

10.2.Targets on testing farms or farming areas

Disease		Year
Member State, zone or compartment109	Total number of farms or mollusc farming areas110	Total number farms or mollusc farming areas under the programme	Number of farms or mollusc farming areas expected to be checked111	Number of expected positive farms or mollusc farming areas112	Number of expected new positive farms or mollusc farming areas113	Number of farms or mollusc farming areas expected to be depopulated	% positive farms or mollusc farming areas expected to be depopulated	Target indicators
Member State, zone or compartment109	Total number of farms or mollusc farming areas110							Expected % farms or mollusc farming areas coverage	% positive farms or mollusc farming areasExpected period farms or mollusc farming areas prevalence	% new positive farms or mollusc farming areasExpected farms or mollusc farming areas incidence
1	2	3	4	5	6	7	8 = (7/5) × 100	9 = (4/3) × 100	10 = (5/4) × 100	11 = (6/4) × 100






Total
Member State, zone or compartment as defined in Point 7 of Annex VI.
Total number of farms or mollusc farming areas existing in the Member State, zone or compartment as defined in Point 7 of Annex VI.
Check means to perform a farm/mollusc farming area level test under the programme for the respective disease with the purpose of upgrading, the health status of the farm/mollusc farming area. In this column a farm/mollusc farming area should not be counted twice even if has been checked more than once.
Farms or mollusc farming areas with at least one positive animal during the period independent of the number of times the farms or mollusc farming areas has been checked.
Farms or mollusc farming areas which health status in the previous period was, in accordance with Part A of Annex III to Directive 2006/88/EC, category I, category II, category III or category IV and have at least one positive animal in this period.

11.Detailed analysis of the cost of the programme (one table per year of implementation)

Costs related to		Specification
1.	Testing
1.1.	Cost of the analysis	Test:
		Test:
		Test:
1.2.	Cost of sampling
1.3.	Other costs
2.	Vaccination or treatment
2.1.	Purchase of vaccine/treatment
2.2.	Distribution costs
2.3.	Administering costs
2.4.	Control costs
3.	Removal and disposal of the aquaculture animals
3.1.	Compensation of animals
3.2.	Transport costs
3.3.	Disposal costs
3.4.	Loss in case of removal
3.5.	Costs from treatment of products
4.	Cleansing and disinfection


5.	Salaries (staff contracted for the programme only)


6.	Consumables and specific equipment


7.	Other costs




Total

Article 1

Article 2

Article 3

Article 4

Article 5

ANNEX I

ANNEX II

ANNEX III

ANNEX IV

ANNEX V

1.Identification of the programme

2.Description of the epidemiological situation of the disease/zoonoses before the date of the beginning of the implementation of the programme and data on the epidemiological evolution of the disease(s)6:

3.Description of the submitted programme7:

4.Measures of the submitted programme to be implemented

4.1.

4.2.

4.3.

4.4.

4.5.

4.6.

5.Financial resources for the implementation of the programme:

6.Data on the epidemiological evolution during the last five years15

6.1.Evolution of the disease

6.2.Stratified data on surveillance and laboratory tests

6.3.Data on infection (one table per year)

6.4.Data on the status of herds at the end of each year (if applicable)

6.5.Data on vaccination or treatment programmes40

6.6.Data on wildlife43

7.Targets

7.1.Targets related to testing (one table for each year of implementation48)

7.1.1.Targets on diagnostic tests

7.1.2.Targets on testing herds and animals

7.2.Targets on qualification of herds and animals (one table for each year of implementation) if applicable.

7.3.Targets on vaccination or treatment (one table for each year of implementation)

7.3.1.Targets on vaccination or treatment74

7.3.2.Targets on vaccination or treatment77 of wildlife

8.Detailed analysis of the cost of the programme (one table per year of implementation)

1.1.

1.2.

2.

2.1.

3.1.

3.2.

3.3.

3.4.

3.5.

5.

ANNEX VI

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☐Zone (part of water catchment area)89

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☐

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☐

☐

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9.Data on the epidemiological situation/evolution of the disease in the last four years (one table for each year of implementation)

9.1.Data on testing animals

9.2.Data on testing farms or farming areas

10.Targets (one table for each year of implementation)

10.1.Targets related to testing animals

10.2.Targets on testing farms or farming areas

11.Detailed analysis of the cost of the programme (one table per year of implementation)