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ANNEX VIIIU.K.PLACING ON THE MARKET AND EXPORT

[F1CHAPTER A U.K. Conditions for F2... trade in live animals, semen and embryos

SECTION A U.K. Conditions which apply to ovine and caprine animals and semen and embryos thereof

[F31. Holdings with a negligible risk of classical scrapie and a controlled risk of classical scrapie: U.K.
1.1.

For the purpose of F4... trade, [F5the appropriate authority] shall, where applicable, establish and supervise an official scheme for the recognition of holdings with a negligible risk of classical scrapie and holdings with a controlled risk of classical scrapie. Based on that official scheme, they shall, where applicable, establish and maintain lists of holdings of ovine and caprine animals with a negligible risk and holdings with a controlled risk of classical scrapie.

1.2.

A holding of ovine animals having the TSE-resistance level I status, as laid down in Annex VII, Chapter C, Part 4, point 1.(a), and where no case of classical scrapie has been confirmed for a period of at least the preceding seven years, may be recognised as having a negligible risk of classical scrapie.

A holding of ovine animals, caprine animals, or ovine and caprine animals may also be recognised as having a negligible risk of classical scrapie provided that it has complied with the following conditions for a period of at least the preceding seven years:

(a)

ovine and caprine animals are permanently identified and records are maintained, to enable them to be traced back to their holding of birth;

(b)

records of movements of ovine and caprine animals in and out of the holding are maintained;

(c)

only the following ovine and caprine animals are introduced into the holding:

(i)

ovine and caprine animals from holdings with a negligible risk of classical scrapie;

(ii)

ovine and caprine animals from holdings which have met the conditions set out in points (a) to (i) for a minimum period of the preceding seven years or for at least the same period of time as the period of time during which the holding, where they are to be introduced, has met the conditions set out in those points;

(iii)

ovine animals of the ARR/ARR prion protein genotype;

(iv)

ovine or caprine animals that comply with the conditions set out in point (i) or (ii) except during the period when they were kept at a semen collection centre, provided that the semen collection centre complies with the following conditions:

  • the semen collection centre is approved [F6and supervised],

  • for a period of the preceding seven years, only those ovine or caprine animals from holdings which have fulfilled during that period the conditions set out in points (a), (b) and (e), and which were subject to regular checks by an official veterinarian or a veterinarian authorised by the competent authority, were introduced into the semen collection centre,

  • no case of classical scrapie has been confirmed at the semen collection centre for a period of the preceding seven years,

  • biosecurity measures are in place at the semen collection centre to ensure that ovine and caprine animals kept at that centre and coming from holdings with a negligible or a controlled risk status for classical scrapie have no direct or indirect contact with ovine and caprine animals coming from holdings of a lower classical scrapie status;

(d)

the holding is subject to regular checks to verify compliance with the conditions set out in points (a) to (i) by an official veterinarian or a veterinarian authorised for that purpose by the competent authority, to be conducted at least on an annual basis F7...;

(e)

no case of classical scrapie has been confirmed;

(f)

F8...

F9... All ovine and caprine animals over 18 months of age that have died or have been killed for reasons other than slaughter for human consumption are tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, point 3.2.

By way of derogation from the conditions set out in the [F10second paragraph of point (f), nothing in this Regulation prevents the appropriate authority from deciding] that all ovine and caprine animals over 18 months of age with no commercial value, culled at the end of their productive life instead of being slaughtered for human consumption, are inspected by an official veterinarian, and all those exhibiting wasting signs or neurological signs are tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, point 3.2.

In addition to the conditions set out in points (a) to (f), the following conditions shall be complied with F11...:

(g)

only the following ova and embryos of animals of the ovine and caprine species are introduced into the holding:

(i)

ova and embryos from donor animals which have been kept since birth in a [F12country or region] with a negligible risk of classical scrapie, or in a holding with a negligible or a controlled risk of classical scrapie, or which comply with the following requirements:

  • they are permanently identified to enable them to be traced back to their holding of birth,

  • they have been kept since birth in holdings in which no case of classical scrapie has been confirmed during their residency,

  • they showed no clinical sign of classical scrapie at the time of collection of the ova or embryos;

(ii)

ova and embryos of animals of the ovine species carrying at least one ARR allele;

(h)

only the following semen of animals of the ovine and caprine species are introduced into the holding:

(i)

semen from donor animals which have been kept since birth in a [F13country or region] with a negligible risk of classical scrapie, or in a holding with a negligible risk or a controlled risk of classical scrapie, or which comply with the following requirements:

  • they are permanently identified to enable them to be traced back to their holding of birth,

  • they showed no clinical sign of classical scrapie at the time of semen collection;

(ii)

semen from rams of the ARR/ARR prion protein genotype;

(i)

ovine and caprine animals on the holding have no direct or indirect contact, including shared grazing, with ovine and caprine animals from holdings of a lower classical scrapie status.

1.3.

A holding of ovine animals, caprine animals or ovine and caprine animals may be recognised as having a controlled risk of classical scrapie provided that it has complied with the following conditions for a period of at least the preceding three years:

(a)

ovine and caprine animals are permanently identified and records are maintained, to enable them to be traced back to their holding of birth;

(b)

records of movements of ovine and caprine animals in and out of the holding are maintained;

(c)

only the following ovine and caprine animals are introduced into the holding:

(i)

ovine and caprine animals from holdings with a negligible or a controlled risk of classical scrapie;

(ii)

ovine and caprine animals from holdings which have met the conditions set out in points (a) to (i) for a minimum period of the preceding three years or for at least the same period of time as the period of time during which the holding, where they are to be introduced, has met the conditions set out in those points;

(iii)

ovine animals of the ARR/ARR prion protein genotype;

(iv)

ovine or caprine animals that comply with the conditions set out in point (i) or (ii) except during the period when they were kept at a semen collection centre, provided that the semen collection centre complies with the following conditions:

  • the semen collection centre is approved [F14and supervised],

  • for a period of the preceding three years, only those ovine or caprine animals from holdings which have fulfilled during that period the conditions set out in points (a), (b) and (e), and which were subject to regular checks by an official veterinarian or a veterinarian authorised by the competent authority, were introduced into the semen collection centre,

  • no case of classical scrapie has been confirmed at the semen collection centre during the period of the preceding three years,

  • biosecurity measures are in place at the semen collection centre to ensure that ovine and caprine animals kept at that centre and coming from holdings with a negligible or a controlled risk status for classical scrapie have no direct or indirect contact with ovine and caprine animals coming from holdings of a lower classical scrapie status;

(d)

the holding is subject to regular checks to verify compliance with the conditions set out in points (a) to (i) by an official veterinarian or a veterinarian authorised for that purpose by the competent authority, to be conducted at least on an annual basis F15...;

(e)

no case of classical scrapie has been confirmed;

(f)

F16...

F17... All ovine and caprine animals over 18 months of age that have died or have been killed for reasons other than slaughter for human consumption are tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, point 3.2.

By way of derogation from the conditions set out in the [F18second paragraph of point (f), nothing in this Regulation prevents the appropriate authority from deciding] that all the ovine and caprine animals over 18 months of age with no commercial value culled at the end of their productive life instead of being slaughtered for human consumption, are inspected by an official veterinarian, and all those exhibiting wasting signs or neurological signs are tested in a laboratory for classical scrapie in accordance with the laboratory methods and protocols set out in Annex X, Chapter C, point 3.2.

In addition to the conditions set out in points (a) to (f), the following conditions shall be complied with F19...:

(g)

only the following ova and embryos of animals of the ovine and caprine species are introduced into the holding:

(i)

ova and embryos from donor animals which have been kept since birth in a [F20country or region] with a negligible risk of classical scrapie, or in a holding with a negligible or a controlled risk of classical scrapie, or which comply with the following requirements:

  • they are permanently identified to enable them to be traced back to their holding of birth,

  • they have been kept since birth in holdings in which no case of classical scrapie has been confirmed during their residency,

  • they showed no clinical sign of classical scrapie at the time of collection of the ova or embryos,

(ii)

ova and embryos of animals of the ovine species carrying at least one ARR allele;

(h)

only the following semen of animals of the ovine and caprine species are introduced into the holding:

(i)

semen from donor animals which have been kept since birth in a [F21country or region] with a negligible risk of classical scrapie, or in a holding with a negligible risk or with a controlled risk of classical scrapie, or which comply with the following requirements:

  • they are permanently identified to enable them to be traced back to their holding of birth,

  • they showed no clinical sign of classical scrapie at the time of semen collection;

(ii)

semen from rams of the ARR/ARR prion protein genotype;

(i)

ovine and caprine animals of the holding have no direct or indirect contact, including shared grazing, with ovine and caprine animals from holdings of a lower classical scrapie status.

1.4.

If a case of classical scrapie is confirmed in a holding with a negligible risk or a controlled risk of classical scrapie, or in a holding found to have an epidemiological link to a holding with a negligible risk or a controlled risk of classical scrapie as a result of an inquiry referred to in Part 1 of Chapter B of Annex VII, the holding with a negligible risk or a controlled risk of classical scrapie shall be immediately deleted from the list referred to in point 1.1 of this Section.

The [F22appropriate authority] shall immediately inform [F23other countries] which have introduced ovine and caprine animals originating from, or semen or embryos collected from ovine and caprine animals kept in the infected holding during a period of the preceding seven years in the case of a holding with a negligible risk of classical scrapie or during the period of the preceding three years in the case of a holding with a controlled risk of classical scrapie.]

Textual Amendments

2. [F24A constituent nation F25... or a zone within a constituent nation] with a negligible risk of classical scrapie U.K.
2.1. Where [F26an appropriate authority] considers that its territory or part of its territory poses a negligible risk of classical scrapie, it [F27must have clear and presentable evidence] that: U.K.
(a)

a risk assessment has been conducted, and it has demonstrated that appropriate measures are currently in place and have been taken for the relevant period of time to manage any risk identified. This risk assessment shall identify all potential factors for classical scrapie occurrence and their historic perspective, in particular the:

(i)

importation or introduction of ovine and caprine animals or their semen and embryos potentially infected with classical scrapie;

(ii)

extent of knowledge of the population structure and husbandry practices of ovine and caprine animals;

(iii)

feeding practices, including consumption of meat-and-bone meal or greaves derived from ruminants;

(iv)

importation of milk and milk products of ovine and caprine animals origin intended for use in feeding of ovine and caprine animals;

(b)

[F3for a period of at least the preceding seven years, ovine and caprine animals displaying clinical signs compatible with classical scrapie have been tested;

(c)

for a period of at least the preceding seven years, a sufficient number of ovine and caprine animals over 18 months of age, representative of ovine and caprine animals slaughtered, that have died or have been killed for reasons other than slaughter for human consumption, have been tested annually, to provide a 95 per cent level of confidence of detecting classical scrapie if it is present in that population at a prevalence rate exceeding 0,1 per cent and no case of classical scrapie has been reported during that period;]

(d)

the feeding to ovine and caprine animals of meat-and-bone meal or greaves of ruminant origin has been banned and effectively enforced in [F28its whole territory] for a period of at least seven years;

(e)

F29...

(f)

introductions from third countries of ovine and caprine animals and semen and embryos thereof are carried out in accordance with Chapter E or Chapter H of Annex IX.

2.2. F30...U.K.
2.3. F31...U.K.
3. National control programme for classical scrapie: U.K.
3.1. [F32each constituent nation must have] a national control programme for classical scrapie covering all of its territory: U.K.
(a)

[F33which outlines] in particular:

  • the distribution of classical scrapie in the [F34constituent nation],

  • the reasons for national control programme, taking into consideration the importance of the disease and the cost/benefit ratio,

  • the status categories defined for holdings and the standards which must be attained in each such category,

  • the test procedures to be used,

  • the national control programme monitoring procedures,

  • the action to be taken if, for any reason, a holding loses its status,

  • the measures to be taken if the results of checks carried out in accordance with the national control programme programme are positive,

(b)

F35...

[F363.2. [F37Within the European Union the national scrapie control programmes for the following Member States have been approved by the European Commission:] U.K.
4. F38...]U.K.