Exporting Bovine Embryos to the United States of America

3 February 2010

bovembec.usa

Ref: AE-US 05L

1. Statutory authority

Pursuant to section 60 of the Animal Products Act 1999:

(i) I notify the following overseas market access requirements, entitled bovine embryos to the United States of America

(ii) Revoke BOVEMBEC.USA 19.12.05.

This notice takes effect from date of signing.

Dated at Wellington this 4^th day of February 2010.

Signed: Matthew Stone BVSc MACVSc MVS (Epidemiology)
Group Manager
Animal Imports and Exports
Border Standards Directorate
MAF Biosecurity New Zealand
(pursuant to delegated authority)

2. The United States of America Requirements

Bovine embryos exported from New Zealand to the United States of America must comply with the import requirements of the United States of America listed in this notice as follows:

2.1 An Import Permit is required for the exportation of bovine embryos to the United States of America.

2.2 An Official Veterinarian of the New Zealand Ministry of Agriculture and Forestry, must certify, after due enquiry, the following:

2.2.1 New Zealand is officially free of Akabane virus, Aino virus, bluetongue, epizootic hemorrhagic disease, brucellosis (Brucella abortus & B. melitensis), contagious bovine pleuropneumonia, ephemeral fever, foot-and-mouth disease and rinderpest.

Vaccination against these diseases is prohibited in New Zealand.

2.2.2 During the 12 months prior to the collection of embryos for export to the United States, there has been no evidence of bovine tuberculosis (Tb) found in the donor dams or on any premises on which the donor dams were located during that time.

2.2.3 The donor dams have been part of the national herd of New Zealand for at least 60 days prior to the collection of the embryos for export to the United States, and they are free from any movement or quarantine restrictions.

2.2.4 During the 60 days prior to the collection of embryos for export to the United States, the donor dams were not corralled, pastured or held with animals of a lesser health status or under any restrictions that would have made them ineligible as embryo donors for export to the United States.

2.2.5 During the 60 days prior to the collection of embryos for export to the United States, the donor dams were inspected by the team veterinarian and appeared healthy, and were found clinically free of diseases transmissible by embryos. The donor sires were also inspected if natural breeding or fresh semen was used for fertilisation.

2.2.6 Each of the donor dams was examined on the day of embryo collection and appeared healthy, and was clinically free of diseases transmissible by embryos.

2.2.7 Each embryo donor (and semen sire in case of natural breeding) originated from a Tb free herd and was tested, with a negative result, to either an intradermal Tb caudal fold test or cervical test performed within 12 months after the last collection of embryos.

The caudal fold test involved the intradermal injection of 0.1 mL M. bovis purified protein derivative (PPD) tuberculin (1 mg/mL PPD) into either side of the caudal fold, with reading by visual observation and palpation 72 hours (plus or minus 6 hours) following injection. A negative test result means no detectable response using both visual examination and palpation.

The cervical test was administered and read as described in the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, i.e. the version current at the time of testing. Date test read.

2.2.8 The embryo collection team:

2.2.8.1 is approved by the New Zealand Ministry of Agriculture and Forestry as having facilities suitable for the collection of embryos for export

2.2.8.2 is under the direct supervision and sanitary control of a team veterinarian who is approved by the New Zealand Ministry of Agriculture and Forestry, and who is responsible for the hygiene of the facilities and the health of the animals.

2.2.9 The embryos were fertilised:

2.2.9.1 either by artificial insemination (AI), using semen from a semen collection centre approved by the New Zealand Ministry of Agriculture and Forestry for the export of semen;

2.2.9.2 or by natural breeding or the use of fresh semen from a donor sire(s) certified as having met the same residency, health and tested health status as the female donor animals;

2.2.9.3 or with semen imported into New Zealand from a country considered by the USDA as free of foot-and-mouth disease and rinderpest.

(To be deleted as appropriate)

2.2.10 The team veterinarian supervised the flushing of embryos from the donor dams and verified that the processing, storage and shipping of those embryos was in accordance with the requirements described in this protocol.

2.2.11 Embryos were collected using a closed flushing system and any instrument or equipment that contacted the tissues of the female reproductive tract or flushing fluids was either new or pre-sterilised equipment.

2.2.12 Each embryo was washed at least 10 times and treated with trypsin, in accordance with the latest published edition of the Manual of the International Embryo Transfer Society (IETS).

2.2.13 Embryos from different donors were not washed together.

2.2.14 After the last wash, each embryo was microscopically examined over its entire surface at not less than 50x magnification and the zona pellucida was found to be intact and free from any adherent material.

2.2.15 The embryos were packaged in straws that were identified in accordance with the latest published edition of the IETS Manual.

2.2.16 All equipment used to process the embryos was either new or sterilised between each use, with standard sterilisation procedures being observed.

2.2.17 All media and additives of ruminant origin, such as fetal bovine serum and bovine serum albumin, were sourced from countries free of foot-and-mouth disease and rinderpest. Trypsin of porcine origin was sourced from countries free of foot-and-mouth disease, rinderpest, classical swine fever and African swine fever.

2.2.18 Prior to its use for exporting embryos to the United States, the shipping container was examined by the team veterinarian and found to be clean and empty of embryos and other biological materials.

2.2.19 The embryos were stored under lock and key, or in the custody of the team veterinarian, and segregated from embryos of a lesser health status until they were placed in the shipping container.

2.2.20 The shipping container contained only new liquid nitrogen and was:

either 2.2.20.1 new

or 2.2.20.2 disinfected. (Name and active ingredient used and date of disinfection.)

(To be deleted as applicable)

2.2.21 Prior to export, the shipping container was sealed by a Ministry of Agriculture and Forestry veterinarian, using a MAF seal bearing the marks to be recorded on the export certificate. Serial number of the shipping container.

3. Definitions

For the purposes of this document:

Any term or expression that is defined in the Animal Products Act 1999 and used, but not defined in this document, has the same meaning as in this Act.

Explanatory Note

These overseas market access requirements are based on the export certificate for bovine embryos to the United States of America, dated 26 March 2009.

Additional Information on OMAR Notification: BOVEMBEC.USA 03.02.10

1. This OMAR replaces the one of 19 December 2005. The only changes made : (i) the use of the term ‘embryo collection team’ rather than embryo collection centre’; and (ii) editorial. The certificate was approved by Dr Betzaida Lopez, APHIS, USDA, in an email dated 3 February 2010.

2. An Import Permit is required. This can be obtained from:

U.S. Department of Agriculture (USDA)
Animal and Plant Health Inspection Service (APHIS)
Veterinary Services (VS)
National Center for Import and Export, (NCIE) Unit 39
4700 River Road,
Unit 39
Riverdale, MD 20737-1231

Telephone: (301) 734-32778364
Facsimile: (301) 734-4704

3. The shipment of the embryo consignment must be routed directly to the United States from New Zealand with no stops en route other than those provided on the USDA Import Permit.

4. The embryos must be collected in by an embryo collection team that is approved by MAF and under the supervision of an embryo team veterinarian approved by MAF.

5. With regards to the front page of the export certificate under II: Information concerning the embryos and semen, for the 'date(s) of collection' and 'straw identification', the words "not applicable" should be entered for the donor bull. For the 'identification' of the donor bull, the same information should be entered as is provided in I: Information concerning the donor animals.

Section 61.A of the Animal Products Amendments Act 2005 states that 'The Crown is not liable, and nor is the Director-General or any employee of the Ministry liable, for any loss arising through the refusal or failure of the relevant authority of an overseas market to admit export animal material or animal product to that market'