Commission Delegated Regulation (EU) 2020/689Show full title

CHAPTER 1 U.K. Surveillance

Section 1 U.K. Design of surveillance, Targeted animal population and diagnostic methods

Article 3 U.K. Design of surveillance

1. The competent authority shall design the surveillance for listed and emerging diseases of terrestrial animals and other animals taking into account:

(a) general surveillance requirements based on:

(i)

notification as provided for in Article 18(1) of Regulation (EU) 2016/429;

(ii)

appropriate veterinary investigation of increased mortalities and other signs of serious diseases or significantly decreased production rates with an undetermined cause;

(iii)

investigation by the competent authority in the event of the suspicion of a category E disease or, if relevant, of an emerging disease;

(iv)

targeted animal population for surveillance as provided for in Article 4;

(v)

the contribution of official controls and other official activities as provided for in Article 7;

(b) specific surveillance requirements:

(i)

in Union surveillance programme;

(ii)

as a part of compulsory or optional eradication programmes;

(iii)

for demonstrating and maintaining disease-free status;

(iv)

as a part of disease control measures;

(v)

in the context of approval of certain establishments;

(vi)

for the movements of terrestrial animals within the Union or their entry into the Union.

2. The competent authority shall design the surveillance for listed and emerging diseases of aquatic animals taking into account:

(a) general surveillance requirements based on:

(i)

notification as provided for in Article 18(1) of Regulation (EU) 2016/429;

(ii)

appropriate veterinary investigation of increased mortalities and other signs of serious diseases or significantly decreased production rates with an undetermined cause;

(iii)

investigation by the competent authority in the event of the suspicion of a category E disease or, if relevant, of an emerging disease;

(iv)

targeted animal population for surveillance as provided for in Article 4;

(v)

the contribution of official controls and other official activities as provided for in Article 7;

(vi)

disease control measures;

(b) specific surveillance requirements:

(i)

as a part of the risk-based surveillance scheme set out in Chapter 1 of Part I of Annex VI, involving a risk ranking and regular animal health visits as provided for in Chapters 2 and 3 of Part I of Annex VI;

(ii)

as a part of the eradication programmes provided for in Chapters 1 to 6 of Part II of Annex VI;

(iii)

for demonstrating and maintaining disease-free status;

(iv)

for demonstrating, in accordance with the surveillance programmes provided for in Chapters 1 to 6 of Part III of Annex VI, that establishments which are not participating in the eradication programme referred to in point (ii) or which have not obtained the disease-free status referred to in point (iii) are not infected;

(v)

for the movements of aquatic animals within the Union or their entry into the Union.

Article 4 U.K. Targeted animal population

1. The competent authority shall specify the targeted animal population relevant to the surveillance referred to in Article 3 for each listed disease and, when relevant, for each emerging disease and shall include:

(a) kept animals of listed species;

(b) wild animals of listed species if:

(i)

they are subject to a Union surveillance programme, or to a compulsory or an optional eradication programme or to the surveillance necessary for the granting or maintenance of a disease-free status;

(ii)

the competent authority considers that they constitute a risk that may impair the health status of other species in a Member State, zone or compartment; or

(iii)

surveillance is necessary to assess animal health requirements for entry into the Union or movements within the Union.

2. To ensure the early detection of an emerging disease in species other than those referred to in point (a) of paragraph 1, the competent authority shall include, in the targeted animal population, kept animals of species that are not listed for the purpose of the relevant listed disease if the following criteria apply:

(a) they are moved to establishments in another Member State, zone or compartment; and

(b) due to the number of animals or the frequency of the movements, the competent authority considers the animals to constitute a risk that might impair the health status of other kept animals in another Member State, zone or compartment, should a disease emerge in that species.

Article 5 U.K. Exclusion of certain kept terrestrial animals from the targeted animal population

1. By way of derogation from point (a) of Article 4(1), the competent authority may limit the targeted animal population for the surveillance of a disease other than a category A disease to the categories of kept animals of listed species that are subject, for that disease, to:

(a) Union surveillance programmes;

(b) compulsory or optional eradication programmes or surveillance necessary for the granting or maintenance of a disease-free status; or

(c) surveillance-based animal health requirements for the movements within the Union or the entry into the Union.

2. The categories of kept animals referred to in paragraph 1 may be based on the animals’ age, their sex, the location and type of production.

Article 6 U.K. Diagnostic methods

1. The competent authority shall ensure that the collection of samples, the techniques, validation and interpretation of the diagnostic methods for the purposes of surveillance shall comply:

(a) with the specific legislation adopted in accordance with Regulation (EU) 2016/429 and the relevant details and guidance made available on the websites of the European Union Reference Laboratories (EURL) and of the Commission;

(b) when not covered by the legislation, details and guidance referred to in point (a), with the collection of samples, the techniques, validation and interpretation of the diagnostic methods laid down in the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the World Organisation for Animal Health (OIE) (‘the Terrestrial Manual’(1) as amended or the Manual of Diagnostic Tests for Aquatic Animals of the OIE (‘the Aquatic Manual’(2) as amended;

(c) when not covered by points (a) and (b) of this paragraph, with the methods laid down in point (b) of Article 34(2) and Article 34(3) of Regulation (EU) 2017/625.

2. The diagnostic methods for granting and maintaining disease-free status are laid down in:

(a) Section 1 of Annex III for infection with Brucella abortus, B. melitensis and B.suis;

(b) Section 2 of Annex III for infection with Mycobacterium tuberculosis complex (Mycobacterium bovis, M.caprae and M. tuberculosis) (MTBC);

(c) Section 3 of Annex III for enzootic bovine leukosis (EBL);

(d) Section 4 of Annex III for infectious bovine rhinotracheitis/infectious pustular vulvovaginitis (IBR/IPV);

(e) Section 5 of Annex III for infection with Aujeszky’s disease virus (ADV);

(f) Section 6 of Annex III for bovine viral diarrhoea (BVD);

(g) point 2 of Section 5 of Chapter 1 of Part II of Annex VI for viral haemorrhagic septicaemia (VHS);

(h) point 2 of Section 5 of Chapter 1 of Part II of Annex VI for infectious haematopoietic necrosis (IHN);

(i) point 2 of Section 5 of Chapter 2 of Part II of Annex VI for infection with highly polymorphic region deleted infectious salmon anaemia virus (HPR-deleted ISAV);

(j) point 2 of Section 5 of Chapter 3 of Part II of Annex VI for infection with Marteilia refringens;

(k) point 2 of Section 5 of Chapter 4 of Part II of Annex VI for infection with Bonamia exitiosa;

(l) point 2 of Section 5 of Chapter 5 of Part II of Annex VI for infection with Bonamia ostreae;

(m) point 2 of Section 5 of Chapter 6 of Part II of Annex VI for infection with white spot syndrome virus (WSSV).

Article 7 U.K. Contribution of official controls and other official activities to animal health surveillance

1. The competent authority shall, if relevant, include in the design of the surveillance referred to in Article 3 of this Regulation the outcome of the official controls and other official activities defined in Article 2 of Regulation (EU) 2017/625. These official controls and other official activities include:

(a) ante-mortem and post-mortem inspections;

(b) inspections at border control posts;

(c) official controls and other official activities at markets and assembly operations;

(d) official controls and other official activities during transport of live animals;

(e) public health related inspections and sampling in establishments;

(f) any other official controls during which establishments, animals or samples are inspected or examined.

2. When the competent authority suspects a listed disease or an emerging disease in the context of official controls or other official activities referred to in paragraph 1, it shall ensure that all relevant authorities are informed. This shall be done:

(a) immediately in case of a category A disease or of an emerging disease;

(b) without delay for other diseases.

Section 2 U.K. Disease confirmation and case definitions

Article 8 U.K. Criteria for official confirmation of listed diseases, other than category A diseases, and certain emerging diseases and subsequent confirmation of outbreaks

1. The competent authority shall, on suspicion of listed diseases, other than category A disease, or of an emerging disease, conduct an investigation to confirm or to rule out the presence of that disease when:

(a) there is a need to determine the health status of the Member State, zone or compartment thereof; or

(b) there is a need to collect necessary information on the occurrence of the disease for any of the following purposes:

(i)

to implement measures to protect animal or human health;

(ii)

to implement animal health requirements for movements of animals or products; or

(iii)

to comply with the requirements laid down in a Union surveillance programme.

2. The competent authority shall confirm an outbreak of any of the diseases referred to in paragraph 1 when it has classified an animal or a group of animals as a confirmed case of these diseases in accordance with Article 9(2).

Article 9 U.K. Case definitions

1. The competent authority shall classify an animal or a group of animals as a suspected case of a listed disease or of an emerging disease when:

(a) clinical, post-mortem or laboratory examinations conclude that clinical sign(s), post-mortem lesion(s) or histological findings are indicative of that disease;

(b) result(s) from a diagnostic method are indicating the likely presence of the disease in a sample from an animal or from a group of animals; or

(c) an epidemiological link with a confirmed case has been established.

2. The competent authority shall classify an animal or a group of animals, as a confirmed case of a listed disease or of an emerging disease when:

(a) the disease agent, excluding vaccine strains, has been isolated in a sample from an animal or from a group of animals;

(b) an antigen or nucleic acid specific to the disease agent that is not a consequence of vaccination has been identified in a sample from an animal or from a group of animals showing clinical signs consistent with the disease or an epidemiological link with a suspected or confirmed case; or

(c) a positive result from an indirect diagnostic method that is not a consequence of vaccination has been obtained in a sample from an animal or from a group of animals showing clinical signs consistent with the disease or an epidemiological link with a suspected or confirmed case.

3. Disease specific definitions of a suspected case and a confirmed case of listed diseases are laid down for terrestrial animals in Annex I and for aquatic animals in point 3 of Section 5 of Chapters 1 to 6 of Part II of Annex VI.

4. In the absence of disease specific definitions as provided for in paragraph 3, the criteria laid down in paragraphs 1 and 2 shall apply to definitions of a suspected case and a confirmed case of listed diseases and, if relevant, emerging diseases.

Section 3 U.K. Union surveillance programme

Article 10 U.K. Criteria for and contents of Union surveillance programmes

1. A category E disease shall be subject to a Union surveillance programme in accordance with Article 28 of Regulation (EU) 2016/429 if it meets all of the following criteria:

(a) it poses a particular threat to animal and possibly human health on the whole Union territory with possible serious economic consequences for the farming community and the wider economy;

(b) it is susceptible to an evolution of the disease profile, in particular with regard to the risk for human health and animal health;

(c) infected wild animals pose a particular threat for the introduction of the disease into a part or the whole of the Union territory;

(d) it is fundamental to obtain, through surveillance, regularly updated information on the evolution of its circulation and on the characterisation of the disease agent, to assess those risks and adapt risk mitigating measures accordingly.

2. The competent authority shall implement Union surveillance programmes for the relevant disease in accordance with the contents set out in Annex II.

Article 11 U.K. Information to be included in the submission of and reporting on Union surveillance programmes

1. The competent authority shall, when submitting a Union surveillance programme, include in that submission at least the following information:

(a) description of the epidemiological situation of the disease before the date of the beginning of the implementation of the programme and data on the epidemiological evolution of the disease;

(b) targeted animal population, epidemiological units and zones of the programme;

(c) organisation of the competent authority, supervision of the implementation of the programme, official controls to be applied during the implementation of the programme and the role of all relevant operators, animal health professionals, veterinarians, animal health laboratories and other natural or legal persons concerned;

(d) description and demarcation of the geographical and administrative areas in which the programme is to be implemented;

(e) indicators to measure the progress of the programme;

(f) diagnostic methods used, number of samples tested, frequency of testing and sampling patterns;

(g) risk factors to be considered for the design of a risk-based targeted surveillance.

2. The competent authority shall, when reporting on a Union surveillance programme, include in that report at least the following information:

(a) the description of the measures implemented and the results obtained based on the information referred to in point (b) and points (d) to (f) of paragraph 1; and

(b) the results of the follow-up of the epidemiological evolution of the disease in case of a suspected or confirmed case.

(1)

http://www.oie.int/en/standard-setting/terrestrial-manual/access-online/

(2)

http://www.oie.int/en/standard-setting/aquatic-manual/access-online/