Importing Laboratory animals from all countries

3 May 2010

labaniic.all

Issued pursuant to Section 22 of the Biosecurity Act 1993
Dated: 03 May 2010

USER GUIDE

The information in this import health standard is in four parts:

Part A. GENERAL INFORMATION describes the legal basis for this import health standard and the general responsibilities of the importer.

Part B. IMPORTATION PROCEDURE outlines whether a permit is required, the conditions of eligibility, and documentation that may need to accompany the consignment.

Part C. CLEARANCE PROCEDURE describes the clearance requirements at the New Zealand border and, if necessary, whether the consignment must go to a transitional facility or containment facility.

PART D. ZOOSANITARY CERTIFICATION contains model health certification which must be completed fully and accompany the consignment to New Zealand.

PART A. GENERAL INFORMATION

1. IMPORT HEALTH STANDARD

Pursuant to section 22 of the Biosecurity Act 1993, this document is the import health standard for the importation into New Zealand of animals for laboratory purposes from all countries.

1.2 Obtaining biosecurity clearance or biosecurity authority for each consignment of laboratory animals imported into New Zealand is dependent upon the consignment meeting the requirements of this import health standard.

1.3 This import health standard may be reviewed, amended or revoked if there are changes in New Zealand's import policy or the animal health status of the originating country, or for any other lawful reason, at the discretion of the Animal Imports/Exports Group Manager.

2. IMPORTER'S RESPONSIBILITIES

2.1 It is the importer's responsibility to ensure that their goods are compliant with the current relevant import health standard at the time of importation. Current versions of import health standards are available online. A register of import health standards is also publicly available for inspection at the office of the Director-General of the Ministry of Agriculture and Forestry, Pastoral House, 25 The Terrace, Wellington, New Zealand.

2.2 The costs to MAF Biosecurity New Zealand in performing functions relating to the importation of laboratory animals must be recovered in accordance with the Biosecurity Act 1993 and any regulations made under that Act. All costs involved with documentation, transport, storage and obtaining a biosecurity clearance must be covered by the importer or agent

3 DEFINITION OF TERMS

Animal Imports/Exports Group Manager

The Animal Imports/Exports Group Manager, Ministry of Agriculture and Forestry Biosecurity New Zealand, or any person who for the time being may lawfully exercise and perform the delegated power and functions of the Animal Imports/Exports Group Manager

Biosecurity authorisation

Written authority from an inspector, given under section 25 of the Biosecurity Act (1993), to move uncleared goods from a transitional facility or biosecurity control area to another transitional facility, containment facility or biosecurity control area, or to export those goods from New Zealand.

Containment facility

As defined by the Biosecurity Act 1993.

Equivalence

Acceptance by MAF Biosecurity New Zealand that measures that are not identical have the same effect.

Animals for laboratory purposes

A group of animals used in laboratories for research that includes rats, mice, hamsters, rabbits and guinea pigs. Such animals may only be from colonies maintained for scientific purposes.

MAFBNZ

Ministry of Agriculture and Forestry Biosecurity New Zealand

New organism

an organism belonging to a species that was not present in New Zealand immediately before 29 July 1998:

New organism an organism belonging to a species that was not present in New Zealand immediately before 29 July 1998:

an organism for which a containment approval has been given under this Act:

a genetically modified organism:

an organism that belongs to a species, subspecies, infrasubspecies, variety, strain, or cultivar that has been eradicated from New Zealand.

Section 2, HSNO Act, 1996.

Inspector

A person appointed as an Inspector under the Biosecurity Act 1993.

Official Veterinarian

A veterinarian authorised by the Veterinary Administration of the country to perform certain designated official tasks associated with animal health and/or public health and inspections of commodities and, when appropriate, to certify in conformity with the provisions of the Section 5.2 of the Terrestrial Code pertaining to principles of certification.

Permit to import

A written order issued by the Director-General of MAF authorising the importation of risk goods to a specified facility.

4. EQUIVALENCE

The import health standard has been agreed as suitable for trade between the exporting and the importing countries. It is expected that the consignment will meet the conditions in every respect.

Occasionally it may be found that, due to circumstances beyond the control of the importer or exporter, a consignment does not comply with the specific requirements in this import health standard, but may meet the outcomes sought. In such cases, a permit to import application may be made, an equivalence granted and import permit issued at the discretion of MAF Biosecurity New Zealand. The following information must be forwarded by the certifying government's veterinary authority for an equivalence to be considered:

• which clause/s of the import health standard cannot be met and how this has occurred;
• the reason the consignment is considered to be of an "equivalent health" status;
• the reasons why the veterinary authority of the country of origin believe this proposal should be acceptable to the New Zealand Ministry of Agriculture and Forestry and their recommendation for its acceptance.

PART B. IMPORTATION PROCEDURE

5. PERMIT TO IMPORT

Application for a permit to import must be made before the proposed date of importation in writing to:

Animal Imports
MAF Biosecurity New Zealand
PO Box 2526
Wellington
New Zealand.
Email: animalimports@maf.govt.nz

5.2 An application for a permit to import shall provide the following information:

(i) name and address of importer

(ii) name and address of exporter

(iii) number, breed or description of the animals for laboratory purposes to be imported

(iv) if the animal is a new organism, evidence must be provided to show that approval has been given by the Environment Risk Management Authority for the organism to be held in containment and the containment controls that apply.

(v) date of the proposed importation

(vi) name and address of the CONTAINMENT FACILITY to which the consignment is to proceed following importation.

5.3 A permit to import will be issued for multiple consignments for a period of up to six months.

6. ELIGIBILITY

6.1 Only animals for laboratory purposes from colonies maintained for scientific use may be imported.

7. DOCUMENTATION ACCOMPANYING THE CONSIGNMENT

7.1 The consignment shall be accompanied by appropriately completed health certification, which meets the requirements of PART D. ZOOSANITARY CERTIFICATION.

7.2 Documentation shall be in English, but may be bilingual (language of exporting country/English).

7.3 It is the importer's responsibility to ensure that any documentation presented in accordance with the requirements of this import health standard is original (unless otherwise specified) and clearly legible. Failure to do so may result in delays in obtaining biosecurity direction and/or clearance or rejection of consignments.

8. TRANSPORT TO NEW ZEALAND

8.1 The animals must be transported in a container that meets the standards prescribed in the International Air Transport Association (IATA), live animal regulations.

8.2 The MAFBNZ Inspectors at the port of arrival must be notified at least 72 hours before the expected time of arrival of any animal, giving the flight number/ship number and arrival time. Contact details can be found at the following MAFBNZ website:

http://www.biosecurity.govt.nz/biosec/org/structure/clearance

PART C. CLEARANCE PROCEDURE

9. BIOSECURITY AUTHORISATION

9.1 Upon arrival in New Zealand, an Inspector must inspect the documentation accompanying the consignment, and may also inspect the packaging, at the port of arrival. The Inspector must not open the container holding the animals.

9.2 An Inspector will authorise movement of the consignment to the containment facility named in the permit to import, providing that the documentation meets all requirements noted under PART D. ZOOSANITARY CERTIFICATION and the consignment meets the conditions of ELIGIBILITY.

10. CONTAINMENT FACILITY

10.1 The consignment must proceed directly from the port of arrival to the containment facility by an approved method of transport and shall be kept separate from any other animals not of equivalent health status. The facility must be approved according to MAF Biosecurity New Zealand Standard 154.03.03 Containment facilities for vertebrate laboratory animals.

10.2 The consignment must remain in quarantine within the containment facility for no less than 30 days or for a longer period if required by the the Animal Imports/Exports Group Manager.

10.3 The operator must have procedures for the maintenance of quarantine and the sterilization of cages and any associated waste products during this period. The shipping container shall either be destroyed, or cleaned and sterilized.

10.4 While in the containment facility the consignment may be subjected to such testing, treatments or procedures required by the Animal Imports/Exports Group Manager, including:

10.4.1 such other tests, treatments or procedures as are reasonably necessary to determine the health status of the consignment.

11. BIOSECURITY CLEARANCE

11.1 On successful completion of the terms detailed under CONTAINMENT FACILITY, the consignment may, subject to sections 27 and 28 of the Biosecurity Act 1993, be given a biosecurity clearance pursuant to section 26 of the Biosecurity Act 1993.

NOTE: New organisms will not be given a biosecurity clearance. They may be removed from isolation but will be directed to remain in the containment facility.

On successful completion of the terms detailed under CONTAINMENT FACILITY, the consignment may, subject to sections 27 and 28 of the Biosecurity Act 1993, be given a biosecurity clearance pursuant to section 26 of the Biosecurity Act 1993.

PART D. ZOOSANITARY CERTIFICATION

The animals for laboratory purposes must be accompanied by:

12.1 A declaration by a veterinarian or senior officer from the institute of origin, named in the permit to import, stating that:

(i) the animals were born in the institution and have not been in contact with any diseased animals, and

(ii) at the time of export they showed no evidence of infectious or contagious disease including ectoparasites.

12.2 A certificate from an official veterinarian of the country of origin certifying that after due enquiry he/she is satisfied that the animals have not been in contact with any animal suffering from an infectious or contagious disease.

12.3 Each consignment must be accompanied by an original certificate signed by the Director/Manager of the institution of origin identifying the species of lab animal and any associated biota as per the Import Permit.