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Annex

Certificate: Veterinary certification for caprine semen from the UK and member states of the EU

Effective 3 November 2022 to 6 June 2023

Note: Veterinary certificates are negotiated directly between relevant government authorities. In cases where a veterinary certificate has not been negotiated, this annex can be used as the basis for developing a suitable document.

  1. This consignment consists of frozen semen in straws or semen pellets collected from goats that immediately prior to the pre-collection period were living in the United Kingdom or a member state of the European Union.

    [The pre-collection period is the 30-day period immediately prior to the first collection of semen for this consignment.]

    [Entry and clearance may only occur at ports specified by Department of Agriculture, Fisheries and Forestry.]

  2. Approval of semen collection centre for export to Australia

    Name of approved centre where the semen was originally collected:

    Name of centre veterinarian:

    Address of approved centre:

    Telephone:

    Fax:

    The semen was collected and processed in a semen collection centre (SCC) meeting the World Organisation for Animal Health (OIE) Code requirements for accreditation. The caprine semen in this consignment was collected, handled and stored in accordance with the OIE Code.

  3. Semen collections were performed under the supervision of either the centre veterinarian or the official veterinarian.
  4. For sex sorted semen, either:

    • Sex sorted semen is NOT included in this shipment,

      or

    • Sex sorted semen IS included in this shipment, and:

    -  equipment used for sex-sorting sperm was cleaned and disinfected between animals according the sex semen licensor’s recommendations; and

    -  where seminal plasma, or components thereof, was added to sorted semen prior to cryopreservation and storage, it was derived from animals of same or better health status.

    [The veterinary certificate must indicate the option that applies.]

  5. Scrapie – freedom assurance

    The semen donors have lived only in a country or zone where:

    • scrapie has been compulsorily notifiable during the previous six years.
    • an effective and continuous national surveillance system is practiced
    • brains from clinically suspect animals are examined in a laboratory in accordance with the diagnostic techniques set out in the OIE Manual of Standards for Diagnostic Tests and Vaccines or the USDA Voluntary Scrapie Herd Certification Program Standards, Appendix 1
    • the feeding of ruminant derived meat-and-bone meal to sheep and goats is banned
    • scrapie-affected sheep and goats are slaughtered and their carcasses disposed of in a manner that would reliably preclude the spread of scrapie infective agent (such as complete incineration)
    • all scrapie affected animals can be traced back to their herd of birth.

    The semen donors originate from herds either:

    - of Certified status in the USDA Voluntary Scrapie Flock Certification Program in which no animals have commingled with sheep during the five years immediately prior to collection.


    or


    - in which no case of scrapie has been confirmed or suspected during the five years immediately prior to semen collection. All animals were identified and can be traced back to their herd of birth. Records of parentage, and movements of animals in and out of the herd, are maintained for a minimum period of five years. During the previous five years, introductions of goats were only permitted from herds with equivalent scrapie status. No animals have commingled with herds of lower scrapie status during the previous five years. No animals have commingled with sheep during the five years immediately prior to collection.

    [Applications will also be considered where information is available which would provide equivalent security for herd freedom for scrapie. Applications for this option must be made to through the veterinary administration of the exporting country.]

    [The veterinary certificate must indicate the option that applies.]

  6. Foot and mouth disease (FMD)

    Immediately prior to the pre-collection period each donor was living in the United Kingdom, or a member state of the European Union, in a country or zone recognised by the OIE as being free from foot and mouth disease.

    The semen was not collected:

    France: between 5 February 2001 and 23 June 2001 (inclusive of these dates).

    Netherlands: between 12 February 2001 and 25 August 2001 (inclusive of these dates).

    Republic of Ireland: between 1 February 2001 and 22 June 2001 (inclusive of these dates).

    United Kingdom: between 1 January 2001 and 15 January 2002 and between 1 July 2007 and 18 February 2008 (inclusive of these dates).

    Cyprus: between 24 September 2007 and 21 February 2008 (inclusive of these dates).

    Bulgaria: after 2 December 2010 (inclusive of this date).

    [These declarations need only be made if the semen is collected in one of the above countries]

  7. Sheep and goat pox

    The exporting country meets the World Organisation for Animal Health (OIE) Code Article definitions for country freedom from sheep and goat pox (capripox virus) and contagious caprine pleuropneumonia.

  8. Enzootic abortion of ewes (EAE)

    Each donor has lived on premises in which EAE had not been diagnosed during the two years immediately prior to the pre-collection period and gave a negative result to a CFT test for EAE during the pre-collection period.

  9. Contagious agalactia (CA)

    Each donor has lived on premises in which contagious agalactia had not been diagnosed during the six months immediately prior to the pre-collection period.

  10. Microchip

    Prior to entry into quarantine each donor was individually identified by microchip implanted midline between the shoulder blades or behind the ear.

  11. Isolation

    Each donor was isolated from all ruminants, except other donors of equivalent health status, during the pre-collection and the collection periods.

  12. Vaccinations

    Donors were not vaccinated against any diseases, except tetanus using a killed vaccine, during the pre-collection period nor during collection.

  13. Clinical examination

    Donors were clinically inspected at least each week during the pre-collection period and on each day blood samples were collected and, at each inspection, were found to be free from signs of contagious and infectious diseases (by the accredited SCC veterinarian, official veterinarian or a registered veterinarian appointed by the centre veterinarian and acting under written instruction).

  14. Testing

    Blood and/or hair samples were collected from each donor for diagnostic tests or DNA testing by the centre veterinarian, the official veterinarian or a registered veterinarian appointed by the centre veterinarian and acting under written instruction.
    [The testing program may be subject to direct audit by Department of Agriculture, Fisheries and Forestry at any time.]

    All tests were performed at laboratories, and using tests, approved by the veterinary administration of the exporting country.

  15. Bluetongue (BT)

    Prior to the export of this consignment each semen donor must be certified as follows for Bluetongue:

    a)

    • A competitive enzyme linked immunosorbent assay (cELISA) for antibody to the bluetongue virus group on a blood sample, with negative results, at least every 60 days throughout the semen collection period and between 28 and 60 days after the final semen collection for this consignment.

      or

    • An agent identification test for bluetongue virus on blood samples drawn from each donor at commencement and conclusion of, and at least every seven days (virus isolation test) or at least every 28 days [approved polymerase chain reaction (PCR) test*] during semen collection for this consignment, with negative results.

    *Real time reverse transcriptase- polymerase chain reaction (RT-PCR) tests must be approved by the competent authority and be able to detect all known 24 BTV serotypes. These tests must use primer sequences directed against highly conserved segments of the bluetongue virus (BTV) genome which code for BTV serogroup (not serotype). An example of an appropriate test is the TaqMan real time RT-PCR test according to the method of Shaw et al. (2007), which uses two primers directed against segment 1 of BTV ribonucleic acid (RNA).

    [Serological testing for BTV antibodies with agar gel immunodiffusion (AGID) tests should not be used.]

    [All tests for BTV should be validated according to the current OIE Manual of diagnostic tests and vaccines for Terrestrial Animals, calibrated to a diagnostic sensitivity of at least 98.0% and carried out in a laboratory approved by the competent authority of the exporting country.]

    AND

    b) Donors vaccinated against BTV:           Yes    /    No

    If Yes, vaccines against BTV administered to semen donors must be:

    - inactivated, and

    - approved by the competent authority in the exporting country, and

    - administered more than 60 days before semen collection for this consignment.

    Name of BTV vaccine used: ………………………………………………………………………………………………..

    Date of administration of BTV vaccine to semen donor …………………………………………………………………...

    [The veterinary certificate must indicate the option that applies. The attached table must include dates of sampling for test, type of tests used, test results.]

  16. Johne’s disease (M. paratuberculosis)

    Donors either:

    • gave a negative result to an absorbed ELISA or AGID for JD between 90 days before the first collection of semen and export

      or

    • has been kept in a herd in which no clinical sign of paratuberculosis was officially reported during the five years immediately prior to collection.

    [The veterinary certificate must indicate the option that applies. The attached table must include dates of sampling for test, type of tests used, test results.]

  17. Brucella melitensis infection

    Donors either:

    • lived only in a country or zone which meets Code requirements for country freedom

      or

    • immediately prior to the pre-collection period, was part of a herd meeting the OIE Code requirements for freedom from B. melitensis infection and gave a negative result to a CFT and a Rose Bengal plate agglutination test for B. melitensis infection on the same blood sample taken during the pre-collection period or at autopsy.

    [The veterinary certificate must indicate the option that applies. The attached table must include dates of sampling for test, type of tests used, test results.]

  18. Caprine arthritis/encephalitis (CAE)

    Each donor either:

    • immediately prior to semen collection, was part of a herd recognised by the veterinary administration as an accredited CAE free herd

      or

    • immediately prior to semen collection, was part of a herd in which CAE had not been diagnosed during the previous three years and during this three year period no commingling with sheep occurred and no animals were introduced from herds with a lesser disease status. Each donor either gave a negative result to an approved enzyme linked immunosorbent assay (ELISA) for CAE virus antibodies on two blood samples collected 30 days apart during the pre-collection period, at the time of collection or at autopsy or was sourced from a herd which tested negative within the six months immediately prior to export.


    [A herd that "tested negative" is a closed herd in which a sample, sufficient to provide 95% probability of detecting evidence of CAE at 10% prevalence, tested negative to an approved AGID or ELISA]

    [The veterinary certificate must indicate the option that applies. The attached table must include dates of sampling for test, type of tests used, test results.]

  19. Schmallenberg virus

    Prior to the export of this consignment each semen donor must be certified as follows for Schmallenberg virus:

    For semen collected on or after 1 June 2011, a virus neutralisation test (VNT) or approved indirect ELISA for antibody to the Schmallenberg virus on a blood sample collected either

    - between fourteen (14) and sixty (60) days after last collection of semen from the donor for this consignment with negative results

    or

    - between fourteen (14) and sixty (60) days before first collection of semen from the donor for this consignment with positive results

    [The veterinary certificate must indicate the option that applies. The attached table must include dates of sampling for test, type of tests used and test results. Laboratory reports for all Schmallenberg virus testing must be provided and attached to the veterinary health certificate.]

  20. Scrapie – post mortem

    The semen donors were at least five years of age at the time of post mortem.

    Before the export of semen each donor was autopsied under the supervision of an official veterinarian or a registered veterinary pathologist employed at a veterinary laboratory approved by the veterinary administration and acting under written instruction from the official veterinarian.

    The donors gave a negative result to tests for scrapie  prion protein (PrPsc) on specimens of brain, brain stem, spinal cord, palatine tonsils, spleen, mesenteric lymph nodes and distal ileum using immunohistochemical methods or techniques of equivalent sensitivity in accordance with procedures laid down by the veterinary administration for the detection of scrapie infective agent.

    [This testing must be carried out at a laboratory approved by the veterinary administration to carry out testing for scrapie prion protein (PrPsc).]

  21. Disinfection of equipment - Scrapie

    Equipment that came in contact with the semen was either new or treated by a process recommended for the disposal of TSE infective agents prior to contacting the semen, in accordance with the recommendations of the veterinary administration.

    [TSE disinfection processes include autoclaving at 136 degrees C for one hour or soaking in a two percent available chlorine solution (equivalent to 20,000 ppm) for one hour. (from Appendix 2 USDA Voluntary Scrapie Flock Certification Program Standards)]

  22. Storage at Approved Centre(s) or Laboratory(ies)

    From the time of collection until export, the reproductive material in this consignment was stored:

    • in sealed containers (e.g. straws, ampoules or vials) and identified in a legible and non-erasable manner as specified in this veterinary certificate.
    • only with other embryos or semen collected for export to Australia, or of equivalent health status.
    • in a secure place within an approved centre or laboratory and under the supervision of the approved veterinarian(s), and in containers containing only new, unused liquid nitrogen.
  23. Further processing or aggregation

    For this reproductive material, either:

    • After leaving the approved centre under seal in shipping containers (liquid nitrogen shippers/tanks), the reproductive material was NOT removed from sealed containers (e.g. straws, ampoules or vials) for further processing or removed from the shipping container(s) for aggregation with other reproductive material.
      or
    • Reproductive material was shipped to another approved centre or laboratory under seal in shipping containers (liquid nitrogen shippers/tanks) and removed from sealed containers (e.g. straws, ampoules or vials) for further processing (e.g. sex sorting) or for aggregation:

    -   with other reproductive material collected for export to Australia, or of equivalent health status 

    -   at an approved centre or laboratory and

    -   under the supervision of the approved veterinarian(s).


    The date(s) of transfer between the approved centre(s) or laboratory(ies), reason for transfer(s) (e.g. for sex sorting), name(s) of the approved centre(s) or laboratory(ies) and the Government approved veterinarian(s) are listed against the shipping container/s on this certificate before departure from the approved centre or laboratory. The unique seal number of each shipping container is included in this documentation.

    Note: For transfers to another approved centre or laboratory, the approved veterinarian must ensure the shipping containers are transferred under seal as described below:

    Date of transfer...................................

    Reason for transfer..................................................................................................................

    Name of approved centre/laboratory...................................................................................................

    Approved veterinarian(s)...........................................................................................................

    Shipping container seal number(s).........................................................................................................

    [The veterinary certificate must indicate the option that applies.]

  24. Shipping containers (Liquid nitrogen shippers/tanks)

    The shipping container was new

    or

    Prior to loading, the shipping container was emptied and inspected and any loose straws removed. The shipping container, including all surfaces in contact with the straws, ampoules or vials was then disinfected with one of the following disinfectants: 2% available chlorine (e.g. chlorine bleach), 2% Virkon, 2.4% Prevail or irradiated at 50 kGy.

    Date of disinfection/ irradiation………………………………………………………...

    Disinfectant used/ active ingredient…………………………………………………….

    [The veterinary certificate must indicate the option that applies. For used shipping containers, the date of disinfection, the disinfectant used and its active chemical must be recorded on the health certificate.]

  25. Official Government Seals

    Under the supervision of an official veterinarian prior to export to Australia:

    - the containers (e.g. straws, ampoules or vials) for reproductive material in this consignment were checked as being sealed.

    - the identity of the reproductive material was checked prior to being placed into new, unused liquid nitrogen in a shipping container for export that was new or disinfected as specified in this veterinary certificate

    - only reproductive material that met Australian import conditions was added to the shipping container

    - the shipping container was sealed with an official government seal and the number or mark on the seal recorded on the certificate.

    Shipping container official government seal number…………………………………...............