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Regulation (EC) No 999/2001 of the European Parliament and of the CouncilShow full title

Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies

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[F1[F21. Holdings with a negligible risk of classical scrapie and a controlled risk of classical scrapie: U.K.
1.1.

For the purpose of F3... trade, [F4the 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 [F5and 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 F6...;

(e)

no case of classical scrapie has been confirmed;

(f)

F7...

F8... 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 [F9second 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 F10...:

(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 [F11country 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 [F12country 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 [F13and 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 F14...;

(e)

no case of classical scrapie has been confirmed;

(f)

F15...

F16... 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 [F17second 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 F18...:

(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 [F19country 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 [F20country 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 [F21appropriate authority] shall immediately inform [F22other 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.]]

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