ANNEX I

CLINICAL EXAMINATIONS, SAMPLING PROCEDURES, DIAGNOSTIC METHODS OF CATEGORY A DISEASES AND TRANSPORT OF SAMPLES(as referred to in Article 3 of this Regulation)

A.Sampling procedures

A.1SAMPLING OF ANIMALS FOR CLINICAL EXAMINATIONS

1.Clinical examinations must include, if possible:

  1. (a)

    animals showing clinical signs of category A diseases;

  2. (b)

    animals likely to have recently died from the suspected/confirmed disease;

  3. (c)

    animals with epidemiological link to a suspected or confirmed case; and

  4. (d)

    animals that obtained positive or non-conclusive results in previous laboratory examinations.

2.

Animals to examine must be selected at random, in a number large enough to allow the detection of the disease, if present, where there are no obvious signs of disease or post-mortem lesions suggesting category A diseases.

3.The animals to examine and the sampling method must be chosen in accordance with the instructions of the competent authority and with the relevant contingency plan as referred to in Article 43 of Regulation (EU) 2016/429. The animals to examine and the sampling method must take into account the disease profile and:

  1. (a)

    the purpose of the sampling;

  2. (b)

    the listed species kept in the establishment;

  3. (c)

    the number of animals of listed species kept in the establishment;

  4. (d)

    the category of the kept animals;

  5. (e)

    the available production, health and traceability records of the kept animals relevant for the investigation;

  6. (f)

    the type of establishment and the husbandry practices;

  7. (g)

    the level of exposure risk:

    1. (i)

      likelihood of exposure to the disease agent or to the vector;

    2. (ii)

      absence of immunisation of the animals due to vaccination or maternal immunity; and

    3. (iii)

      history of residence in the establishment;

  8. (h)

    other relevant epidemiological factors.

4.The minimum number of animals to examine must be in accordance with the instructions of the competent authority and with the relevant contingency plan as referred to in Article 43 of Regulation (EU) 2016/429. The minimum number of animals to examine must take into account the disease profile and in particular:

  1. (a)

    the expected prevalence in the establishment;

  2. (b)

    the level of confidence desired of the survey results, which in any case must not be lower than 95 %; and

  3. (c)

    international standards and available scientific evidence.

A.2SAMPLING OF ANIMALS FOR LABORATORY EXAMINATIONS

1.

Sampling for laboratory examinations must take into account the outcome of the clinical examinations referred to in point A.1 and, if possible, must include animals referred to in paragraph 1 of point A.1.

2.

If there are no obvious signs of disease or post-mortem lesions suggesting category A diseases, samples must be collected at random in each epidemiological unit of the establishment and must allow the detection of the disease, if present.

3.

The animals to sample, the nature of the samples to collect and the sampling method must be in accordance with the instructions of the competent authority and with the relevant contingency plan as referred to in Article 43 of the Regulation (EU) 2016/429. The animals to sample, the nature of the samples to collect and the sampling method must take into account the disease profile and the criteria set out in paragraph 3 of point A.1.

4.

The minimum number of animals to sample must be in accordance with the instructions of the competent authority and the relevant contingency plan as referred to in Article 43 of the Regulation (EU) 2016/429. The minimum number of animals to sample must take into account the criteria set out in paragraph 4 of point A.1 and the performance of the tests used.

5.

In the case of wild animals, samples must be collected from animals shot, found dead or purposely trapped or must be obtained on the basis of non-invasive methods such as salt licks and chewing ropes or baits. The minimum number and the nature of the samples must take into account the estimated size of the wild population and the relevant criteria set out in paragraph 3 and 4 of point A.1.

A.3SAMPLING OF ESTABLISHMENTS FOR VISITS

1.

The choice of establishments to sample and the sampling method must be in accordance with the instructions of the competent authority and with the relevant contingency plan as referred to in Article 43 of the Regulation (EU) 2016/429. The choice of establishments to sample and the sampling method must take into account the disease profile and the criteria set out in paragraph 3 of point A1.

2.

The minimum number of establishments to visit must be in accordance with the instructions of the competent authority and with the relevant contingency plan, as referred to in Article 43 of the Regulation (EU) 2016/429.

B.Diagnostic methods

The techniques, reference materials, their standardisation and the interpretation of the results of tests carried out using the relevant diagnostic methods for category A diseases must comply with Article 6 and Part III of Annex VI to Delegated Regulation (EU) 2020/689.

The diagnostic methodology must aim to maximise the sensitivity of the surveillance. In certain circumstances this surveillance may include the use of laboratory examinations in order to assess previous exposure to disease.

C.Transport of samples

1.All samples taken to confirm or rule out the presence of a category A disease must be sent, with a proper labelling and identification, to an official laboratory which has been informed of their arrival. These samples must be accompanied by the appropriate forms, in accordance with the requirements established by the competent authority and the laboratory receiving the samples. These forms must include at least:

  1. (a)

    the establishment of origin of the sampled animals;

  2. (b)

    information on the species, age and category of the sampled animals;

  3. (c)

    the clinical history of the animals, if available and relevant;

  4. (d)

    the clinical signs and post-mortem findings; and

  5. (e)

    any other relevant information.

2.All samples must be:

  1. (a)

    stored in watertight and unbreakable containers and packages and in accordance with applicable international standards;

  2. (b)

    kept at the most appropriate temperature and other conditions during transport taking into account the factors that may affect the sample quality.

3.The exterior of the package must be labelled with the address of the recipient laboratory and the following message must be prominently displayed:

‘Animal pathological material; perishable; fragile; do not open outside the laboratory of destination.’

4.

The person responsible in the official laboratory receiving the samples must be informed in due time of the arrival of the samples.