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Annex

Certificate: Veterinary certification for bovine semen from the USA

Effective 24 March 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. During the period between the first and last semen collection for this consignment, the USA was recognised by the Office International des Epizooties (OIE) as a foot and mouth disease (FMD) free country where vaccination is not practised and met the OIE Code Article definitions of country freedom from:

    • rinderpest
    • contagious bovine pleuro pneumonia
    • lumpy skin disease
    • Rift Valley fever.
  2. At the time of semen collection the donors were part of the resident herd at a semen collection centre that was either:

    • a participant in CSS (Certified Semen Services, Inc).

      OR

    • complied with CSS Minimum Requirements for Disease Control of Semen Produced for artificial insemination and was inspected and approved by USDA.

      [The veterinary certificate must indicate the option that applies]
  3. For testing purposes, the period between the first and last collection of semen from each donor certified on this health certificate was not more than 90 days.
  4. 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:




    Telephone:

    Fax:

  5. An accredited veterinarian:

    • ensured the isolation of the donors from all other ruminants not of equivalent health status prior to semen collection
    • supervised the isolation period
    • supervised the collection of specimens for testing
    • recorded the required details for each donor on a table attached to the veterinary certificate
    • supervised the collection and processing of the semen in accordance with the CSS Requirements
    • ensured that suitable antibiotics were added to the diluent and that the diluents were prepared in accordance with CSS or Code Article 3.2.1.9. and
    • verified the permanent identification of the semen straws with the identification details of the donor and the date of collection or a code from which this information could be determined.
  6. 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.]
  7. All blood, tissue and semen tests for disease were carried out at a laboratory approved by United States Department of Agriculture (USDA) to perform the test required for that disease. Where diagnostic tests are not specified by these conditions, only those tests recognised by the USDA for the disease being tested were used.
  8. All donors were examined and tested for bovine tuberculosis, bovine brucellosis, bovine pestivirus (all bovine genotypes including bovine viral diarrhoea [BVDV] genotypes 1 and 2), bovine genital campylobacteriosis and trichomoniasis in accordance with the CSS requirements. All tests were negative.
  9. Bluetongue

    • Blood samples drawn from each donor between 28 and 60 days after final semen collection for this consignment, gave negative results to the competition ELISA for BT antibodies. (For serum samples collected before Oct 2003 Department of Agriculture will accept testing between 21 and 90 days post collection, with negative results).

      OR
    • Blood samples were drawn from each donor at the commencement and conclusion of semen collection and at least every seven days during semen collection and gave negative results to a virus isolation test for BT.

      OR
    • Blood samples were drawn from each donor at the commencement and conclusion of semen collection and at least every 28 days during semen collection and gave negative results to a polymerase chain reaction test for BT.

      OR
    • Semen was collected prior to 6 February 2023


      AND

    • Collection dates were between 15 January and 15 May, from donors resident in a USDA designated bluetongue low incidence state for at least 60 days prior to, and during, semen 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.]

  10. Epizootic haemorrhagic disease of deer (EHD)

    • Blood samples drawn from each donor between 28 and 60 days after final semen collection for this consignment, gave negative results to either an agar gel immunodiffusion (AGID) test or a virus neutralisation test for EHD antibodies. (For serum samples collected before Oct 2003 Department of Agriculture, Fisheries and Forestry will accept testing between 21 and 90 days post collection, with negative results).


      OR

    • Blood samples were drawn from each donor at the commencement and conclusion of semen collection and at least every seven days during semen collection and gave negative results to a virus isolation test for EHD.

      OR

    • Blood samples were drawn from each donor at the commencement and conclusion of semen collection and at least every 28 days during semen collection and gave negative results to a polymerase chain reaction test for EHD.


      OR

    • Semen was collected prior to 6 February 2023

      AND

    • Collection dates were between 15 January and 15 May, from donors resident in a USDA designated bluetongue low incidence state for at least 60 days prior to, and during, semen 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.]

  11. Bovine brucellosis and tuberculosis
    During the time of semen collection the semen collection centre was either:

    • Officially free from bovine brucellosis and bovine tuberculosis as defined by OIE Code.

      OR
    • Certified brucellosis-free and accredited (tuberculosis free) by the USDA:APHIS, for five years prior to the final collection of semen for this consignment.

      OR
    • Located in a Class Free (brucellosis) and Accredited-Free (tuberculosis) State or area.

      [The veterinary certificate must indicate the option that applies.]
  12. Enzootic bovine leucosis (EBL)

    • Each donor originated from a herd certified by USDA APHIS as free from EBL, and the resident herd at the AI Centre was free from EBL as defined by the OIE Code (Article 3.2.4.2.).

      OR
    • Each donor was tested for EBL, by an approved serological test, virus isolation test, or a polymerase chain reaction test from a blood sample collected between 21 days and 90 days after the final collection of semen for this consignment, with negative results.

      OR
    • An aliquot of not less than 0.5ml of processed semen from the final collection of each donor was tested by an approved virus isolation test or a polymerase chain reaction test with negative results.

      [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.]
  13. Infectious bovine rhinotracheitis/ Infectious pustular vulvovaginitis (IBR/IPV)
    One of the following options (A or B or C) must be met.
    The semen was collected from donors:
    a) in IBR/IPV free artificial insemination centres which are considered to be those that fulfilled the IBR/IPV testing requirements during pre-quarantine, in the quarantine station and annually, as specified below.

    • Bulls and teaser animals should enter an artificial insemination centre only if they fulfil the following requirements:

    Pre-quarantine (i.e. prior to entering the quarantine station/pre-entry isolation facility)

    If the artificial insemination centre is to be considered as IBR/IPV free, the animals should either:

    • come from an IBR/IPV free herd as defined in Article 11.13.3 of the OIE Terrestrial Animal Health Code 2009; or
    • be subjected, with negative results, to a serological test for IBR/IPV on a blood sample taken at a maximum of 60 days before entry to the quarantine station.

    The donor bulls have been maintained in isolation from animals not of equivalent tested status from the time of IBR/IPV testing. This includes no contact with cattle not of equivalent test status during transport to the quarantine station/collection centre.

    Testing in the quarantine station (i.e. pre-entry isolation facility) prior to entering the semen collection facilities
    Prior to entering the semen collection facilities of the artificial insemination centre, bulls and teaser animals should be kept in a quarantine station for at least 28 days.

    The animals should be subjected, with negative results, to a diagnostic test for IBR/IPV on a blood sample a minimum of 21 days after entering the quarantine station. All the results should be negative. If any animal tests positive, the animal should be removed immediately from the quarantine station and the other animals of the same group should remain in quarantine and be retested, with negative results, not less than 21 days after removal of the positive animal.

    • All bulls and teasers resident in the semen collection facilities should be tested at least annually for IBR-IPV with negative results:

    OR


    b) secured in isolation during the period of collection and were subjected to either an ELISA or virus neutralisation test (VNT) for IBR/IPV on blood samples taken at least 21 days after collection of the semen with negative results

    Note: “isolation” means that the relevant donor animals must be secured within double stock-proof fences separated by three metres during the period of collection, or donor bulls could be secured within a solid impervious fully enclosed structure for the period of collection.

    OR

    c) whose serological status is unknown or positive for IBR/IPV, and from which an aliquot of each semen collection for export was subjected to a virus isolation test (by cell culture inoculation and a minimum of two passages if no cytopathic effect observed on first passage) or real-time polymerase chain reaction (RT-PCR) assay, with negative results. Only collections that have been tested as described above are eligible for importation to Australia. Semen from bulls collected in periods between tests is not eligible.

    [The veterinary certificate must indicate the option that applies. For options (B) and (C) the attached table must include dates of sampling for test, type of tests used, test results.]

    Note (1): All diagnostic tests and the interpretation of test results for IBR/IPV must comply with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals chapter on Infectious bovine rhinotracheitis/ Infectious pustular vulvovaginitis. This applies to all testing undertaken irrespective of option selected.

    Note (2): If an ELISA is the serological test of choice for IBR/IPV, the ELISA used has been validated with respect to sensitivity, specificity and reproducibility (see OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, Chapter 1.1.4 Principles of validation of diagnostic assays for infectious diseases) and is suitable for certification of bovine semen for Australia.

  14. Johne’s disease (M. paratuberculosis)
    Each donor showed no clinical signs of Johne’s disease during the collection period.
  15. Vesicular stomatitis
    Vesicular stomatitis was not reported within 15 kilometres of the SC Centre during the period 30 days before the first collection of semen for this consignment and until completion of the final collection of semen for this consignment.
  16. Schmallenberg virus
    No cases of disease caused by Schmallenberg virus have been detected or reported in the United States of America.
  17. 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 direct supervision of the approved veterinarian(s), and
    • in containers containing only new, unused liquid nitrogen.
  18. 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 direct 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.]

  19. 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 50kGy.

    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.]
  20. Official Government Seals
    Under the direct supervision* of an Official Government 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.
    • An official government seal was applied by an Official Government Veterinarian to the shipping container and the number or mark on the seal recorded on the certificate.

Shipping container official government seal number…………………………………...............
*Supervision means the Official Government Veterinarian must be present and ensure the final clearance checks are undertaken, as specified above.