Annex

Certificate: Veterinary certificate for the export of in vivo caprine embryos from the UK

Effective 30 September 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.

Unless otherwise specified, 'donor' refers to both the female donor of the ova and the male donor of the semen used to fertilise the ova to produce the embryos.

Foot and mouth disease (FMD)
Immediately prior to the pre-collection period each donor was living in the United Kingdom of Great Britain and Northern Ireland which is recognised by the World Organisation for Animal Health (WOAH) as being free from foot and mouth disease.
The embryos were NOT collected in:
United Kingdom of Great Britain and Northern Ireland: between 1 January 2001 and 15 January 2002 and between 1 July 2007 and 18 February 2008 (inclusive of these dates).
The exporting county meets WOAH Code Article definitions for country freedom from sheep and goat pox (capripox virus) and contagious caprine pleuropneumonia.
The embryos came from donors (both male and female) five years of age or older prior to export of the embryos which had 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 which are slaughtered or die are examined in a laboratory in accordance with the diagnostic techniques set out in the WOAH Manual of Diagnostic Tests and Vaccines for Terrestrial Animals
- 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)
- procedures are followed which allow tracing of each scrapie affected animal back to its herd of birth.
The embryos came from donors (both male and female) five years of age or older prior to export of the embryos which originated from herds:
- in which no case of scrapie has been confirmed or suspected during the five years immediately prior to collection
- in which no animals have commingled (animals grouped together having physical contact. This does not include incidental contact between animals away from the flock’s premises, such as occurs at shows and sales) with sheep during the five years immediately prior to collection
- in which all animals are identified and can be traced back to their herd of birth
- for which records of parentage, and movements of animals in and out of the herd, are maintained for a minimum period of five years
- into which, during the previous five years, introductions of goats were only permitted from herds of an equivalent scrapie status

AND
- in which no animals have commingled with herds of lower scrapie status during the previous five years

OR
for which confirmed information is available which would provide equivalent security to the above.*

*[Note: Applications for this option must be made to Department of Agriculture, Fisheries and Forestry through the competent authority of the exporting country.]

[The veterinary certificate must indicate the option that applies.]
Each donor was isolated from all ruminants, except other donors of equivalent health status, during the pre-collection and the collection periods. Prior to entry into quarantine each donor was individually identified by microchip implanted midline between the shoulder blades or behind the ear. The microchip or electronic implant is any radio frequency identification device approved for use by the exporting country veterinary administration which is tamper resistant and readable by equipment available to the veterinary administration. The donors must be identified by scanning the microchip at each process which requires certification.
Donors were:

- not vaccinated against any diseases, except tetanus using a killed vaccine, during the pre-collection period nor during collection
- 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 team veterinarian, official veterinarian or a registered veterinarian appointed by the team veterinarian and acting under written instruction).
All animal health testing, to meet these conditions, was performed at laboratories and using tests, approved by the veterinary administration of the exporting country.
Bluetongue (BT)
Prior to the export of this consignment each female embryo donor must be certified as follows for Bluetongue:

a)
- A competitive enzyme linked immunosorbent assay (cELISA) for antibody to the bluetongue virus (BTV) group on a blood sample, with negative results, between 28 and 60 days after the collection of embryos for this consignment.

OR
- A bluetongue virus isolation test or an approved real time reverse- transcriptase polymerase chain reaction (RT- PCR) test* on a blood sample taken on the day of collection of embryos 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 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 WOAH 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 embryo donors must be:
- inactivated, and
- approved by the competent authority in the exporting country, and
- administered more than 60 days before embryo collection for this consignment.

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

Date of administration of BTV vaccine to embryo 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.]
Brucella melitensis infection
Each donor:
- has lived only in a country or zone which meets WOAH Code requirements for country freedom,

OR
- immediately prior to the pre-collection period, was part of a herd officially free from B melitensis infection according to the WOAH Code Article definitions and gave a negative result to a complement fixation test (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.]
Contagious agalactia (CA)
Each donor has lived on premises in which contagious agalactia has not been diagnosed during the six months immediately prior to the pre-collection period.
Caprine arthritis/encephalitis (CAE)
Each donor:

a) immediately prior to embryo collection was part of an accredited CAE free herd recognised by the veterinary administration of the exporting country

OR

b) immediately prior to embryo 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

AND

Gave a negative result to either an approved ELISA for CAE antibodies on two blood samples collected 30 days apart during the pre-collection period, at the time of embryo collection or at autopsy or was sourced from a flock which tested negative within the 6 months immediately prior to export. (A flock which “tested negative” is defined as a closed flock in which a sample, sufficient to provide 95% probability of detecting evidence of CAE at 10% prevalence, tested negative to a 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.]
Enzootic abortion of ewes (EAE)
Each donor:
- has lived on premises in which enzootic abortion of ewes (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.

[The attached table must include dates of sampling for test, type of tests used, test results.]
The semen donors were of equivalent tested health assurance standards to those prescribed for the female donors and the embryos were produced:
- by insemination with fresh semen collected from identified males

OR
- by insemination with semen collected, processed and stored at centres registered under the competent authority of the exporting country.

[The veterinary certificate must indicate the option that applies.
Schmallenberg virus
Prior to the export of this consignment each embryo donor must be certified as follows for Schmallenberg virus:

For embryos collected on or after 1 June 2011, a virus neutralisation test or approved indirect ELISA for antibody to the Schmallenberg virus on a blood sample collected
EITHER

- between 14 and 60 days after last collection of embryos from the donor for this consignment with negative results

OR

- between 14 and 60 days before first collection of embryos 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.]
Before the export of embryos, each female donor:
- was autopsied under the direct 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
- 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.

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

[The attached table must include dates of sampling for test, type of tests used, test results.]
The embryos were collected, handled and stored in accordance with the WOAH Code Appendix definitions. Materials of animal origin used during the collection, handling or storage of the embryos contained no living micro-organisms, were sourced from Australia or New Zealand and were subjected to quality control methods in accordance with Chapter 10 of the Manual of the International Embryo Transfer Society (IETS) 4th edition, 2010. Equipment which came in contact with the embryos, or the reproductive organs of the donors, was either new or treated by a process recommended for the disposal of TSE infective agents in accordance with the recommendations of the veterinary administration of the exporting country*.
*[Note: 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 Scrapie Flock Certification Program Standards)]
The embryos:
- have been fertilised in vivo
- were collected and processed by an embryo collection team supervised by an approved team veterinarian and meet the requirements specified in WOAH Code Appendix definitions and veterinary certificate section of this document
- were not subjected to micromanipulation involving breaching of the zona pellucida
- all had an intact zona pellucida at the time of storage.
Approval of embryo collection team veterinarian for export to Australia

Name of approved centre where the embryos were originally collected:

Name of centre veterinarian:

Address of approved centre:

Telephone:
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.
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 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.]
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.]
Official government seals
Under the direct 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…………………………………...............

Signature of official government veterinarian:	Official position:
Name and address of government authority:	Date:	Official stamp:

Name of approved centre where the embryos were originally collected:	Name of centre veterinarian:
Address of approved centre:	Telephone: