Laboratory Animal Services STANDARD OPERATING PROCEDURES AND POLICIES IMPORTING RODENTS INTO AUSTRALIA. (Last updated 29 April 2005) This document is based AQIS Condition C8478 “Quarantine requirements for the importation of live laboratory rats and mice and their reproductive material”. The full document can be found at: http://www.affa.gov.au/corporate_docs/publications/pdf/market_access/biosecurity/animal/2003/200306a.pdf Summary Please read this document carefully in full. For orientation purposes, however, the most important steps to be aware of are: 1) 3 to 4 months prior to import: Obtain an Import Permit from AQIS. Ensure other approvals are in place - i.e. Animal Ethics, Materials Transfer Agreement (if required by the supply institution) and, in the case of transgenic animals, OGTR approval. Make courier arrangements through supply institution. 2) Within 72 hours prior to import: Arrange for supply institution to fax flight arrival details and an Animal Health Certificate (signed by institutional and government veterinarians within 72 hours prior to departure). Confirm that the supply institution will enclose copies of the AQIS Animal Health Certificate and Import Permit with the consignment. Option to bypass quarantine in Australia AQIS provides the option for “off-shore” or pre-export quarantine. This means that as long as certain health-testing criteria are met by the supply institution overseas, animals may be imported without having to be held in quarantine after arriving in Australia. Note, however that the criteria for off-shore quarantine are very stringent and it is generally easier to proceed with the routine quarantine process. Details of the criteria may be obtained from the Director and are also provided on the attached AQIS Animal Health Certificate template. Countries These notes relate to applications to import from the following countries: USA, Canada, Japan, NZ, EU member states, Switzerland and Israel. Applications to import from other countries require individual assessment by AQIS. Responsibilities The LAS Director is willing to assist in the preparation of import documentation and assessment of health reports etc if desired by the researcher. The Director will also perform the necessary steps following receipt of the animals into the University’s quarantine facility (i.e. blood testing and seeking AQIS approval for release). In general, it is preferred that the researcher arranges the actual transport of animals from door to door since this often involves agreements with collaborators that were made independently of LAS. Documents required prior to import 1) AQIS Permit: Once issued, this is usually valid for 12 months. 2 same Permit may be used for more than one Unless stated otherwise on the Permit, the consignment of animals provided that the animals are of a similar type and are coming from the same institution. All shipments must of course occur within the period for which the Permit is valid. A copy of the Permit must accompany each consignment of animals. Application forms for Permits are available from AQIS at: http://www.affa.gov.au/content/publications.cfm?ObjectID=FA8F4F8B-7F1C-4E65B6842822AD932B64 or tel 8334 7444. AQIS charge an application fee of $80 plus an assessment fee of $180 for an import permit; the total payment of $260 must accompany the application which can be submitted to: AQIS Animal Quarantine, PO Box 657, Mascot NSW 1460. Note that the only AQIS approved quarantine premises for housing rodents is Room 719, Blackburn building. The AQIS registration number of this facility is N 0544. Once issued, a copy of the Permit must be supplied to Director, LAS. 2) Animal Ethics Committee approval letter. Animals must be covered by a current AEC approval; this might be an existing protocol (provided that the animals to be imported are listed in the protocol), or you might require modification of an existing protocol in order to cover the imported animals. A form to apply for modification of an existing protocol can be found at: http://www.usyd.edu.au/ethics/animal/ If you intend to breed the imported animals (as is usually the case), this will also need to be covered by your protocol. If applying for a new or modified AEC protocol, please note that AEC meetings are held monthly except January when the Committee is in recess. Note also that the approval number is usually not issued for several days until after the meeting date and even longer in cases where the Committee has requested additional information. Meeting dates can be found at: http://www.usyd.edu.au/ethics/animal/ A full copy of AEC approval letter must be supplied to animal house staff. 3) In the case of transgenic (but not gene knockout, knockin, ENU mutant or spontaneous mutant) animals, you will need approval from the Institutional Biosafety Committee. Further information is available from the University’s Biosafety Officer, Ms Jenny Dawkins, (jdawkins@finance.usyd.edu.au, ext 14126). This is a legal requirement under the Commonwealth Gene Technology Act. 4) Animal Health Certificate: An Animal Health Certificate must accompany each consignment of mice, even if these consignments are being imported under the same Import Permit. AQIS does not provide a formal blank form for this purpose. However, you will find a template at the end of this document that was prepared by LAS in consultation with AQIS staff and it is recommened that you provide this to the supplying institution for completion. The Certificate requests important information including the number of animals in the consignment. The number of animals cited on the Animal Health Certificate must match the number of animals in the consignment. The Certificate must be signed by an Official Veterinarian and the veterinarian in charge of the donor colony. An Official Veterinarian is a civil service veterinarian or one specially appointed under the authority of the veterinary administration of the exporting country. Each page of the Certificate has to be stamped by the veterinarian’s official stamp. A copy of the Certificate must be faxed to AQIS (fax 02-8334 7430) at least 24 hours prior to arrival of animals. Alternatively, the Director will do this on your behalf provided of course that he receives a copy within the necessary time frame! 5) Health monitoring information. This is not a statutory requirement but rather is intended to help avoid the introduction of pathogens into University facilities. 3 covered in the Animal Health Certificate) should Recent health monitoring information (if not be forwarded to the Director, LAS. Alternatively, you may provide the Director with email or fax details of the manager or veterinarian in charge of the colony of origin. Other steps to take prior to import Please contact the Director to confirm that there is sufficient space to house your animals at the time required. Upon dispatch by exporting institution As indicated above, a copy of the Animal Health Certificate must reach AQIS at least 24 hours prior to the scheduled arrival of the animals. The fax must also state the flight arrival details so that AQIS can be advised to ensure that an inspector is available to clear the shipment as quickly as possible. The flight arrival details and the Animal Health Certificate may be faxed directly to AQIS (fax 02 – 8334 7430) or to the LAS Director (9351 4950); if choosing the latter, please confirm that the Director has received the fax and forwarded it to AQIS. Copies of the Animal Health Certificate and Import Permit must accompany the consignment. Upon arrival If your animals require post-arrival quarantine (as is almost invariably the case), they must be held in the AQIS-approved quarantine facility in the Blackburn animal house until cleared by AQIS. Clearance by AQIS requires the collection of blood samples for serological testing for hantavirus (the blood is collected by LAS then submitted to an independent laboratory). If the test results come back negative, the animals will then be cleared by AQIS. Provided that the animals have been kept suitably isolated prior to their departure from the supply institution, the blood samples can be collected immediately upon arrival in quarantine. If there are doubts about the degree of isolation prior to importing, then they must be kept in quarantine for at least 30 days before blood may be collected for testing. Note that animals may be bred while in quarantine provided that this is approved in your AEC protocol. If there is a possibility that your animals are immunodeficient, blood is collected from sentinel animals that will have been housed along with the imported animals. The time from blood collection to AQIS clearance is usually about 2 weeks. The cost of testing is met by LAS. Animals meeting the requirements for off-shore quarantine may be released directly into a non-quarantine animal facility. Malcolm France Director, Laboratory Animal Services University of Sydney NSW 2006 Australia Tel 61-2-9351 3603; Fax 9351 4950; Email m.france@las.usyd.edu.au 4 ANIMAL HEALTH CERTIFICATE/VETERINARY CERTIFICATE for the export of live laboratory rodents to Australia Each page of the Animal Health Certificate must be signed by an Official Veterinarian and bear an Official stamp. SECTION I: IDENTIFICATION OF ANIMALS INCLUDE TABLE HERE FOR DETAILS RE ANIMALS (SPECIES, NUMBER, BREED, SEX, AGE) SECTION II: EXPORTER’S DETAILS Name of exporting animal facility: Address of exporting facility: Contact person, telephone, fax and email: SECTION III: IMPORTER’S DETAILS Importing animal facility: Address of importer: Contact person, telephone, fax and email: AQIS Import Permit number: Terms used: Colony: The entire group of animals that is in contact with the animals to be exported or the donors of the reproductive material. In contact animals are those that share airspace, handlers and equipment and are not separated by air filters or any similar physical barrier. SECTION IV: SANITARY INFORMATION I, …………………………..(name), being the veterinarian in charge of the colony from which the animals were derived, certify as follows: 5 1. The animals for export (or the donors of genetic material) have been bred and housed for their lifetime in premises that are part of a bone fide scientific institution. 2. The colony of origin is housed in accommodation that precludes access by wildlife, including rodents and insect vectors, and is free of infestation with ectoparasites. 3. Pre-export isolation. In the 30 days prior to the date of export, the animals to be exported and any animals in contact with them have remained isolated by means of micro-isolators or other similar biologically secure means from animals not of equivalent health status. 4. Disease freedom: hantavirus, ectromelia virus and rabies. During the 12 months prior to the date of export there has been no clinical or other evidence of infectious agents in the colony including hantaviruses, ectromelia virus and rabies. During pre-export isolation there were no new introductions to the isolation unit and the animals remained clinically healthy and free from evidence of hantaviruses, ectromelia virus and rabies. 5. Hantavirus testing. EITHER*: The colony was tested with negative results for hantaviruses by enzyme-linked immunosorbent assay (ELISA) during the 6 months prior to export. Animals that were tested were be at least 8 weeks of age. The number of animals tested provided 99% confidence of detecting disease at 25% prevalence. Laboratory reports are attached and include the date of blood sampling, number of animals tested and the number of animals in the colony. OR* Sentinels of the same species, 8-12 weeks of age were placed in boxes with the donor animals (other forms of contact may occur where AQIS has provided written advice). An appropriate number of sentinels were tested to provide 99% confidence of detecting disease at 25% prevalence. The sentinels remained in contact for a minimum of 45 days but not more than 120 days prior to testing. Sentinels were tested with negative results for hantavirus by enzyme-linked immunosorbent assay (ELISA) during the 6 months immediately prior to collection. Laboratory reports are attached and include the date of blood sampling, number of animals tested and the number of animals in the colony. [Sentinel testing is generally used where immunocompromised animals are involved or animals are otherwise unsuited to be tested directly.] OR* Tesing for hantaviruses did not occur. [Animals will be directed to a Quarantine Approved Premises on arrival in Australia.] *delete clauses that are not applicable. 6. No new animals were introduced to the donor colony (unless from a colony tested negative for hantavirus) between the time of testing for hantavirus and export. 6 7. Within 72 hours prior to loading, each animal for export was examined by me and was free from evidence of infectious and contagious disease and ectoparasites. CERTIFYING VETERINARIAN (veterinarian in charge of the colony) Name Signature Address and full contact details Date 7 OFFICIAL VETERINARIAN Name and title: ………………………………………………………………………………… Signature: ………………………………………………………………… Address and full contact details: ………………………………………………………………. ………………………………………………………………. ………………………………………………………………. ………………………………………………………………. Date…………………………… Official Stamp