2 June 2010
This Biosecurity Australia Advice (BAA) provides stakeholders with a draft policy review of the biosecurity risks for bluetongue virus (BTV) associated with the importation of cattle, sheep, goat and deer semen and embryos from the European Union (EU), and cattle semen and embryos from Switzerland and Norway. The review has been undertaken in response to the emergence of new strains of BTV in Europe that cause disease and deaths in cattle, as well as in sheep and goats.
The review assesses the latest scientific information on developments in Europe, and concludes that the interim measures introduced in July 2008, with modification to BTV testing requirements, appropriately manage the risks in accordance with Australia's conservative approach to quarantine.
We would welcome stakeholder comments by 2 August 2010.
A new strain of BTV, BTV serotype 8 (BTV8) that is exotic to Australia and causes disease and deaths in cattle, as well as in sheep and goats, first appeared in the Netherlands and Belgium in 2006, and spread rapidly across Europe over 2007-2008. Evidence has emerged of transplacental transmission of virus in cows, with abortion and foetal malformation of calves. These characteristics appear to be unique to the strain of BTV8 in Europe. Subsequently, another four new serotypes of BTV (1, 6, 11 and Toggenburg Orbivirus) were detected in northern Europe over 2008-2009. The latter three serotypes are also exotic to Australia.
Australia imports genetic material derived from several ruminant species from EU Member States and cattle semen and embryos from two countries which are not EU members (Switzerland and Norway). In July 2008, in response to new scientific information on the transmission of BTV8, Biosecurity Australia recommended to the Australian Quarantine and Inspection Service (AQIS) that interim quarantine requirements be introduced for embryos from the EU, Norway and Switzerland, and that import permits for some commodities should be issued on a case-by-case basis, pending a more detailed analysis. Interim risk management measures included BTV testing of donors of cattle embryos.
Australia has now undertaken the review of Australia's risk management for BTV for these countries. The review analyses available information on BTV8 and other serotypes of BTV in Europe and evaluates the risk presented by BTV8 compared with other serotypes of BTV in Europe at each stage of semen and embryo collection. The review concludes that the strain of BTV8 in Europe
- presents a greater likelihood of transmission through insemination and embryo transfer than other serotypes of BTV; and
- is more likely to cause clinical signs in cattle, be shed in semen, transmitted transplacentally and cause foetal malformation.
As the risks exceed Australia's appropriate level of protection (ALOP), risk management measures are proposed. The measures take into account relevant EU legislation and World Organisation for Animal Health (OIE) Code recommendations:
- Embryos of cattle, sheep, goats and deer must continue to be collected in vivo, processed and washed ten times according to International Embryo Transfer Society (IETS) protocols.
- For the EU, BTV testing (as outlined below) of donors of cattle, sheep and goat and deer embryos and semen.
- For Switzerland and Norway, BTV testing (as outlined below) of donors of cattle embryos and semen.
- BTV test requirements:
o Donors to test negative to a competitive enzyme linked immunosorbent assay (cELISA) against BTV antibody, or a BTV virus isolation test, or a real time-reverse transcription polymerase chain reaction (RT-PCR) test. -
- Serological testing for BTV antibodies with agar gel immunodiffusion (AGID) tests should not be used.
- Serological testing to occur at 60 day intervals during the semen collection period and at between 28 and 60 days after semen or embryo collection.
- RT-PCR tests must be capable of detecting all serotypes of BTV, as well as BTV8, because of the need to exclude new isolates of field or attenuated vaccine strains of BTV.
- If used, vaccines against BTV administered to semen and embryo donors must be inactivated; and approved by the competent authority in the exporting country; and administered more than 60 days before semen or embryo collection.
The draft review report is available from Biosecurity Australia's website. Stakeholder comments should be submitted by 2 August 2010 to Biosecurity Australia at the following address:
Animal Biosecurity
Biosecurity Australia
GPO Box 858
Canberra ACT 2601
Telephone: (02) 6272 3933
Facsimile: (02) 6272 3399
E-mail: Animal Biosecurity
An electronic version of submissions would be appreciated. Biosecurity Australia will consider all stakeholder comments as it finalises the policy review.
Information on risk assessments and policy reviews being conducted by Biosecurity Australia is available from our website.
Please pass this notice to other interested parties. If those parties wish to be included in future communications on this matter they should get in touch with the contact officer (details below).
Confidentiality
Stakeholders are advised that, subject to the Freedom of Information Act 1982 and the Privacy Act 1988, all submissions received in response to BAAs will be publicly available. Comments may be listed or referred to in any papers or reports prepared on the subject matter of the Advice.
The Commonwealth reserves the right to reveal the identity of a respondent unless a request for anonymity accompanies the submission. Where a request for anonymity does not accompany the submission the respondent will be taken to have consented to the disclosure of their identity for the purposes of Information Privacy Principle 11 of the Privacy Act 1988.
The contents of the submission will not be treated as confidential unless they are marked 'confidential' and they are capable of being classified as such in accordance with the Freedom of Information Act 1982.
[signed]
Robyn Martin
General Manager
Animal Biosecurity
Contact officer: Libby Salmon
Telephone no.: +61 2 6272 3933
Facsimile no: +61 2 6272 3399