NZS BIO BOVFBSIC.AUS (2001) (English): Importing Foetal bovine serum, calf serum and bovine serum, tested, filtered and irradiated from Australia (Updated 12 March 2001) [By Authority of The Biosecurity Act of 1993] We will sell to no man, we will not deny or defer to any man either justice or right. Magna Carta— T ūtohinga Nui Kore rawa e hoko ki te tangata, e kore e whakakhoretia, ā e tautuku rnei te tangata ki te ture, tika ranei. ā IMPORT HEALTH STANDARD FOR THE IMPORTATION INTO NEW ZEALAND OF TESTED, FILTERED AND IRRADIATED FOETAL BOVINE SERUM, CALF SERUM AND BOVINE SERUM FROM AUSTRALIA USER GUIDE The information in MAF animal and animal product import health standards is presented in numerically ordered sections with descriptive titles. Sections are grouped into one of four parts, designated alphabetically. Part A. GENERAL INFORMATION contains sections of general interest, including those relating to the legal basis for MAF import health standards and the general responsibilities of every importer of animals and animal products. Part B. IMPORTATION PROCEDURE contains sections that outline the requirements to be met prior to and during importation. Whether a permit to import is required to be obtained prior to importation is noted, as are conditions of eligibility, transport and general conditions relating to documentation accompanying the consignment. Part C. CLEARANCE PROCEDURE contains sections describing the requirements to be met at the New Zealand border and, if necessary, in a transitional facility in New Zealand prior to any consignment being given biosecurity clearance. Part D. ZOOSANITARY CERTIFICATION contains model health certification which must be completed by the appropriate personnel as indicated in the certification and accompany the consignment to New Zealand. When MAF has accepted health certification produced by a government authority in the exporting country as meeting the requirements of the model health certification this is noted. When no health certification is required to accompany consignments Part D. will note “none required”. PART A. GENERAL INFORMATION 1 IMPORT HEALTH STANDARD 1.1 Pursuant to section 22 of the Biosecurity Act 1993, this document is the import health standard for the importation into New Zealand of tested, filtered and irradiated foetal bovine serum, calf serum and bovine serum from Australia. 1.2 Obtaining biosecurity clearance for each consignment of commodity imported into New Zealand from Australia 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 Director Animal Biosecurity. Import Health Standard for Tested, Filtered and Irradiated Foetal Bovine Serum, Calf Serum and Bovine Serum from Australia BOVFBSIC.AUS 12 March 2001 Page 1 of 7 2 IMPORTER'S RESPONSIBILITIES 2.1 The costs of MAF in performing functions relating to the importation of a commodity shall be recovered in accordance with the Biosecurity Act and any regulations made under that Act. 2.2 All costs involved with documentation, transport, storage and obtaining a biosecurity direction and/or biosecurity clearance shall be borne by the importer or agent. 3 DEFINITION OF TERMS biosecurity clearance Means a clearance under section 26 of the Biosecurity Act 1993 for the entry of goods into New Zealand. Director Animal Biosecurity The Director Animal Biosecurity, New Zealand Ministry of Agriculture and Forestry, or any person who for the time being may lawfully exercise and perform the power and functions of the Director Animal Biosecurity. equivalence Acceptance by MAF that the circumstances relating to the importation of a consignment are such that the health status of the consignment is equivalent to the health status of a consignment that complies with the requirements of the import health standard. New Zealand Inspector As defined by the Biosecurity Act 1993. MAF The New Zealand Ministry of Agriculture and Forestry. Official Veterinarian A civil service veterinarian or a specially appointed veterinarian, as authorised by the Veterinary Administration of the country. 4. EQUIVALENCE 4.1 It is expected that the animal product will meet the conditions of this import health standard in every respect. If the products do not comply with the requirements, an application for equivalence may be submitted to MAF for consideration. Detailed information supporting the application for equivalence must be forwarded to MAF for a decision. Import Health Standard for Tested, Filtered and Irradiated Foetal Bovine Serum, Calf Serum and Bovine Serum from Australia BOVFBSIC.AUS 12 March 2001 Page 2 of 7 PART B. IMPORTATION PROCEDURE 5. PERMIT TO IMPORT 5.1 Importation into New Zealand of tested, filtered and irradiated foetal bovine serum, calf serum and bovine serum from Australia which meet the requirements of this import health standard may, subject to sections 27 and 28 of the Biosecurity Act, be given biosecurity clearance and do not require a biosecurity direction to a transitional facility. As such, they do not require a permit to import. 6. ELIGIBILITY 6.1 Product must be imported pre-packaged ready for use by the end-user and sealed so that contamination cannot occur during transit. 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 specified 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. PART C. CLEARANCE PROCEDURE 8. BIOSECURITY CLEARANCE 8.1 Upon arrival in New Zealand the documentation accompanying the consignment shall be inspected by an Inspector at the port of arrival. The Inspector may also inspect the consignment, or a sample of the consignment. 8.2 Providing that the documentation meets all requirements noted under PART D. ZOOSANITARY CERTIFICATION and the consignment meets the conditions of ELIGIBILITY, 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. Import Health Standard for Tested, Filtered and Irradiated Foetal Bovine Serum, Calf Serum and Bovine Serum from Australia BOVFBSIC.AUS 12 March 2001 Page 3 of 7 PART D. ZOOSANITARY CERTIFICATION 9. NEGOTIATED EXPORT CERTIFICATION The following documents are recognised by MAF as equivalent to the requirements of PART D. ZOOSANITARY CERTIFICATION, and are approved to accompany imports of tested, filtered and irradiated foetal bovine serum, calf serum and bovine serum from Australia when appropriately completed by a representative of the exporting country’s competent authority. Import Health Standard for Tested, Filtered and Irradiated Foetal Bovine Serum, Calf Serum and Bovine Serum from Australia BOVFBSIC.AUS 12 March 2001 Page 4 of 7 10. MODEL ZOOSANITARY CERTIFICATION I. COMMODITY: TESTED, FILTERED AND IRRADIATED FOETAL BOVINE SERUM, CALF SERUM AND BOVINE SERUM II. CERTIFYING AUTHORITY: i. Agency: ii. Department: iii. Country: III. ORIGIN OF THE CONSIGNMENT i. Name/s and address/es of processing premises: ii. Processing premises registration number (if applicable): IV. CONSIGNMENT DESCRIPTION i. Number of packages: ii. Nature of packaging: iii. Nature of the goods: iv. Animal species product derived from: v. Number of the container(s) and container seal number(s): vi. Weight in kilograms (kg): V. CONSIGNMENT INFORMATION i. Name and address of exporter: ii. Name and address of New Zealand importer: VI. DESTINATION OF THE CONSIGNMENT i. Port of loading/disembarkation: ii. Vessel/voyage number: iii. Port of destination in New Zealand: VII. ZOOSANITARY INFORMATION Import Health Standard for Tested, Filtered and Irradiated Foetal Bovine Serum, Calf Serum and Bovine Serum from Australia BOVFBSIC.AUS 12 March 2001 Page 5 of 7 MANUFACTURER DECLARATION I, ......................................., being the manager of the factory where the tested, filtered and irradiated foetal bovine serum, calf serum and bovine serum identified in this Zoo-Sanitary Certificate has been processed, certify that: 10.1 This product was manufactured using processes which comply with an industry accepted code of good manufacturing practice and using a quality system equivalent to ISO 9002 that records details of the product description, the origin and nature of each batch of product, the manufacturing process, the quality control testing carried out and packaging and consignment details. 10.2 EITHER 10.2.1 This product has been filtered to 0.22✳m or less and has been irradiated with a single or multiple irradiation dose totalling 5 mrad (50 kgray). OR 10.2.2 This product has been subject to triple 0.1 micron membrane filtration and has been irradiated with a single or multiple irradiation dose totalling 2.5 mrad (25 kgray), AND The product has been tested and found free of mycoplasma. It has also been tested and found free from bovine virus diarrhoea, infectious bovine rhino tracheitis, bluetongue and parainfluenza-3 using the methods described in ‘Australian Standard Diagnostic Techniques for Animal Diseases’. 10.3 The products were derived from cattle born and reared in Australia. In the case of foetal bovine serum, it was obtained from blood collected from foetuses whose dams were born and raised in Australia. 10.4 EITHER 10.4.1 Product sourced from abattoirs was derived from animals which passed ante-mortem and post-mortem inspection and were processed in premises under the supervision of the controlling authority and in accordance with the regulations of Australia. OR Import Health Standard for Tested, Filtered and Irradiated Foetal Bovine Serum, Calf Serum and Bovine Serum from Australia BOVFBSIC.AUS 12 March 2001 Page 6 of 7 10.4.2 Product sourced from donor herds was derived from herds that were under veterinary supervision and the animals were clinically free from infectious or contagious diseases. Signature of Manufacturer: Date: 10.5 After due enquiry, I have no reason to doubt the veracity of the Manufacturer's Declaration. Signature of Official Veterinarian: Date: Name and Address of Office: N.B. Official stamp of the government veterinary authority of the exporting country must be applied to all pages of zoosanitary certification. Ref: AI-AU40I BOVFBSIC.AUS Import Health Standard for Tested, Filtered and Irradiated Foetal Bovine Serum, Calf Serum and Bovine Serum from Australia BOVFBSIC.AUS 12 March 2001 Page 7 of 7