Import Health Standard for Biological Products from All Countries

31 January 2010

bioprodic.all

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This standard is issued pursuant to Section 22 of the Biosecurity Act 1993

Dated: 31 January 2010

The information in this import health standard is in three 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 to import 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 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 biological products from all countries.

1.2 To be eligible for biosecurity direction or biosecurity clearance, the consignment must meet the requirements of this import health standard.

2 IMPORTER'S RESPONSIBILITIES

2.1 It is the responsibility of the importer or agent to ensure that they are compliant with the current relevant import health standard at the time of importation. Current versions of import health standards are available online at: http://www.biosecurity.govt.nz/ihs/search

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 MAFBNZ in performing functions relating to the importation of biological products must be recovered in accordance with the Biosecurity Act 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 DEFINITIONS

biological product

Non-viable products derived from living organisms. {Note: Biological products derived from humans are exempt from this import health standard)

biosecurity clearance

A clearance under section 26 of the Biosecurity Act 1993 for the entry of goods into New Zealand. (Explanatory Note: Goods given a Biosecurity Clearance by an Inspector may be released to the importer without restriction).

biosecurity direction

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

consignment

Unaccompanied goods being moved from one country to another covered by a consignment note or waybill.

equivalence

Acceptance by MAFBNZ 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.

Inspector

A person appointed under section 103 of the Biosecurity Act 1993 to undertake administering and enforcing the provisions of the Biosecurity Act. (Explanatory Note: Goods given a Biosecurity Clearance by an Inspector are released to the importer without restriction).

MAFBNZ

Ministry of Agriculture and Forestry Biosecurity New Zealand.

permit to import (import permit)

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

risk good

Any organism, organic material, or other thing, or substance, that (by reason of its nature, origin, or other relevant factors) it is reasonable to suspect constitutes, harbours, or contains an organism that may:

Cause unwanted harm to natural and physical resources or human health in New Zealand, or
Interfere with the diagnosis, management, or treatment, in New Zealand, of pests or unwanted organisms.

transitional facility

Means (a) any place approved as a transitional facility in accordance with section 39 [of the Biosecurity Act 1993] for the purpose of inspection, testing, storage, treatment, holding or destruction of uncleared goods; or (b) a part of a port declared to be a transitional facility in accordance with section 39 [of the Biosecurity Act 1993].

4 EQUIVALENCE

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

4.2 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, equivalence granted and permit to import issued at the discretion of MAFBNZ. The following information must be forwarded by the certifying government's veterinary authority for an equivalence to be considered:

which requirement/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, and
the reasons why the veterinary authority of the country of origin believe this proposal should be acceptable to MAFBNZ and their recommendation for its acceptance.

PART B. IMPORTATION PROCEDURE

5 PERMIT TO IMPORT

5.1 A permit to import is required for all biological products imported under this standard and must be issued prior to importation. A permit to import may include multiple biological products.

5.2 An application form to apply for a permit to import can be obtained from the MAFBNZ website: http://www.biosecurity.govt.nz/forms/imports-biologicals-microorganisms

5.3 The following information must be provided on the application form for each biological product:

Importer and Exporter:
- name and address of importer (if the importer is not an individual (e.g. a company or institution), then the name of an authorised contact person must be supplied),
- name and address of the end user (if known), if different from the importer,
- country of origin and name and address of exporter (if known), the exporter may be listed as ‘various’ on the permit to import if the biosecurity risk is negligible, and
- name and address of the transitional facility to which the consignment is to proceed (if the biological product is eligible for biosecurity clearance then it will not be directed to a transitional facility).

Biological Product Description:
- name of the biological products to be imported,
- description of biological products (e.g. a list of ingredients of animal, microbial or plant origin), and
- intended use of biological products.
- To assist risk assessment, MAFBNZ may request additional information.

6 ELIGIBILITY

16.1 The following items are not eligible for importation under this import health standard:

6.1.1 Biological products derived from humans are exempt from this import health standard and can therefore be given biosecurity clearance.

6.2 All non-viable animal and plant products may be eligible for import under this standard.

Note:

Biological products (non-viable animal or plant products) that are eligible for import under a more specific import health standard are not eligible for import under this import health standard. When a biological product meets the specific requirements of another import health standard the products must be imported under that other import health standard. For other import health standards please refer to the MAF Biosecurity New Zealand website: http://www.biosecurity.govt.nz/ihs/search

6.3 Biological products that are assessed by MAFBNZ not to be risk goods, or risk goods with a negligible risk, may be eligible for biosecurity clearance provided that all of the following requirements are met:

6.3.1 The products are non-viable

6.3.2 The consignment is accompanied by a copy of the permit to import

6.3.3 All the conditions on the permit to import are met

6.4 Biological products assessed by MAFBNZ to be risk goods, may be eligible for biosecurity direction provided the following requirements are met:

6.4.1 The products are non-viable

6.4.2 The consignment is accompanied by a copy of the permit to import

6.4.3 All the conditions on the permit to import are met

6.4.4 The transitional facility listed on the permit to import is approved at the time of import to either MAF Regulatory Authority Standard:

- 154.02.17 - Transitional Facilities for Biological Products; or

- BNZ-STD-TFGEN - Standard for General Transitional Facilities for Uncleared Risk Goods - ANNEX G: Holding of Biological Products.

and any subsequent amendments to those Standards at the time of import.

These standards are available from the MAFBNZ website: http://www.biosecurity.govt.nz/regs/trans/stds.

6.5 Biological products that are assessed by MAFBNZ as presenting unacceptable risks to biosecurity in New Zealand will not be eligible for import.

7 DOCUMENTATION ACCOMPANYING THE CONSIGNMENT

7.1 The consignment must be accompanied by appropriately completed documentation. It is the importer’s responsibility to ensure that any documentation clearly legible. Failure to do so may result in rejection of consignments or delay in obtaining biosecurity clearance and/or biosecurity direction.

7.2 Copies of the documentation accompanying a consignment should also be securely attached to the outside of the package.

7.3 Documentation must be in English, but may be bilingual (language of exporting country and English).

8 TRANSPORT OF BIOLOGICAL PRODUCTS

8.1 It is the importers responsibility to ensure that biological products are transported according to the requirements of the International Air Transport Association (IATA) Dangerous Goods Regulations. These are available at http://www.iata.org/

PART C. BIOSECURITY DIRECTION/CLEARANCE PROCEDURES

9 BIOSECURITY CLEARANCE AND DIRECTION

9.1 Upon arrival of consignments of biological products in New Zealand, an inspector must inspect the documentation accompanying the consignment. The inspector may also inspect the consignment, or a sample of the consignment.

9.2 Biological products may be eligible for biosecurity clearance pursuant to section 26 of the Biosecurity Act 1993, or biosecurity direction to move to the transitional facility named in the permit to import pursuant to section 25 of the Biosecurity Act 1993 provided the consignment is accompanied by a permit to import and complies with the conditions of that permit and the conditions of ELIGIBILITY.

9.3 The transitional facility must be operating according to MAF Regulatory Authority Standard: