F1ANNEX IIDETERMINATION OF BSE STATUS

Annotations:

CHAPTER DMinimal surveillance requirements

1.Surveillance types

For the purpose of this Annex, the following definitions shall apply:

  1. (a)

    Type A surveillance

    The application of Type A surveillance will allow the detection of BSE at a design prevalence19 of at least one case per 100 000 in the adult bovine animals population in the country or region of concern, at a confidence level of 95 %;

  2. (b)

    Type B surveillance

    The application of Type B surveillance will allow the detection of BSE at a design prevalence of at least one case per 50 000 in the adult bovine animals population in the country or region of concern, at a confidence level of 95 %.

    Type B surveillance may be carried out by countries or region of negligible BSE risk status to confirm the conclusions of the risk analysis, for example by demonstrating the effectiveness of the measures mitigating any risk factors identified, through surveillance targeted to maximise the likelihood of identifying failures of such measures.

    Type B surveillance may also be carried out by countries or regions of controlled BSE risk status, following the achievement of the relevant points target using Type A surveillance, to maintain confidence in the knowledge gained through Type A surveillance.

    For the purpose of this Annex, the following four sub-populations of bovine animals have been identified for surveillance purposes:

    1. (a)

      bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects);

    2. (b)

      bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without assistance; bovine animals over 30 months of age sent for emergency slaughter or with abnormal observations at ante-mortem inspection (casualty or emergency slaughter);

    3. (c)

      bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock);

    4. (d)

      bovine animals over 36 months of age at routine slaughter.

2.Surveillance strategy

2.1.

The surveillance strategy shall be designed to ensure that samples are representative of the herd of the country or region, and include consideration of demographic factors such as production type and geographic location, and the potential influence of culturally unique husbandry practices. The approach used and the assumptions made shall be fully documented, and the documentation retained for seven years.

2.2.

In order to implement the surveillance strategy for BSE, a country shall use documented records or reliable estimates of the age distribution of the adult bovine animals population and the number of bovine animals tested for BSE stratified by age and by sub-population within the country or region.

3.Points values and point targets

Surveillance samples must meet the point targets set out in Table 2, on the basis of point values fixed in Table 1. All clinical suspects shall be investigated, regardless of the number of points accumulated. A country shall sample at least three out of the four sub-populations. The total points for samples collected shall be accumulated over a period of a maximum of seven consecutive years to achieve the target number of points. The total points accumulation shall be periodically compared to the target number of points for a country or region.

Table 1Surveillance point values for samples collected from animals in the given sub-population and age category

Surveillance sub-population

Routine slaughter20

Fallen stock21

Casualty slaughter22

Clinical suspect23

Age ≥ 1 year and < 2 years

0,01

0,2

0,4

N/A

Age ≥ 2 years and < 4 years (young adult)

0,1

0,2

0,4

260

Age ≥ 4 years and < 7 years (middle adult)

0,2

0,9

1,6

750

Age ≥ 7 years and < 9 years (older adult)

0,1

0,4

0,7

220

Age ≥ 9 years (aged)

0,0

0,1

0,2

45

Bovine animals over 36 months of age at routine slaughter.

Bovine animals over 30 months of age which are found dead or killed on farm, during transport or at an abattoir (fallen stock).

Bovine animals over 30 months of age that are non-ambulatory, recumbent, unable to rise or to walk without assistance; bovine animals over 30 months of age sent for emergency slaughter or with abnormal observations at ante-mortem inspection (casualty or emergency slaughter).

Bovine animals over 30 months of age displaying behavioural or clinical signs consistent with BSE (clinical suspects).

Table 2Points targets for different adult bovine animals population sizes in a country or region

Points targets for countries or regions

Adult bovine animals population size(24 months and older)

Type A surveillance

Type B surveillance

1 000 000

300 000

150 000

800 000-1 000 000

240 000

120 000

600 000-800 000

180 000

90 000

400 000-600 000

120 000

60 000

200 000-400 000

60 000

30 000

100 000-200 000

30 000

15 000

50 000-100 000

15 000

7 500

25 000-50 000

7 500

3 750

4.Specific targeting

Within each of the sub-populations above in a country or region, a country may target bovine animals identifiable as imported from countries or regions where BSE has been detected and bovine animals which have consumed potentially contaminated feedstuffs from countries or regions where BSE has been detected.

5.BSE surveillance model

A country may choose to use the full BSurvE model or an alternative method based on the BSurvE model to estimate its BSE presence/prevalence.

6.Maintenance surveillance

Once the points target has been achieved, and in order to continue to designate the status of a country or region as controlled BSE risk or negligible risk, surveillance can be reduced to Type B surveillance (provided all other indicators remain positive). However, to continue to comply with the requirements laid down in this Chapter, ongoing annual surveillance must continue to include at least three of the four prescribed sub-populations. In addition all bovine animals clinically suspected of being infected with BSE shall be investigated regardless of the number of points accumulated. The annual surveillance in a country or region following the achievement of the required points target, shall be no less than the amount required for one-seventh of its total Type B surveillancetarget.