Import Health Standard for Microorganisms from All Countries

31 January 2010

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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 your general responsibilities as an importer.

Part B. IMPORTATION PROCEDURE outlines whether a permit to import is required, the conditions of eligibility, and documentation that may need to accompany your 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 the importation of microorganisms 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 microorganisms 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 biosecurity clearance or biosecurity direction must be covered by the importer or agent

3 DEFINITIONS

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.

Chief Technical Officer

A person appointed a chief technical officer under section 101 of the Biosecurity Act 1993.

consignment

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

containment facility

A place approved in accordance with section 39 of the Biosecurity Act 1993, for holding organisms that should not, whether for the time being or ever, become established in New Zealand.

equivalence

Acceptance by MAF 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.

ERMA

Environmental Risk Management Authority.

HSNO Act 1996

Hazardous Substances and New Organisms Act 1996.

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: An Inspector is appointed to undertake administering and enforcing the provisions of the Biosecurity Act and controls imposed under the Hazardous Substances and New Organism Act 1996).

IBSC

Institutional Biosafety Committee, appointed by ERMA to have delegated authority under sections 19, 40 and 42 of the HSNO Act 1996, to assess applications for the:

(a) development of low-risk genetically modified organisms in containment, and

(b) importation of low-risk genetically modified organisms into containment.

MAFBNZ

Ministry of Agriculture and Forestry Biosecurity New Zealand

microorganism

A microscopic organism including protozoa, fungi, bacteria, viruses, unicellular algae and prions.

new organism

A new organism is defined in section 2 of the HSNO Act 1996 as:

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

(b) an organism belonging to a species, subspecies, infrasubspecies, variety, strain, or cultivar prescribed as a risk species, where that organism was not present in New Zealand at the time of promulgation of the relevant regulation,

(c) an organism for which a containment approval has been given under this Act,

(ca) an organism for which a conditional release approval has been given,

(cb) a qualifying organism approved for release with controls,

(d) a genetically modified organism,

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

For advice on new organism status contact ERMA New Zealand (www.ermanz.govt.nz ).

permit to import (import permit)

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

risk good

means 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:

(a) Cause unwanted harm to natural and physical resources or human health in New Zealand; OR

(b) 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].

unwanted organism

Any organism that a chief technical officer believes is capable or potentially capable of causing unwanted harm to any natural and physical resources or human health (Biosecurity Act 1993). For further reference please use the link below to view the unwanted organisms register: http://www.biosecurity.govt.nz/pests/registers/uor

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 microorganisms imported under this standard and must be issued prior to importation. A permit to import can include multiple microorganism species.

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 microorganism:

• 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 or containment facility to which the consignment is to proceed (if the microorganism is eligible for biosecurity clearance then it will not be directed by MAFBNZ to either type of facility).

• Microorganism Description:
  • latin binomial (incl. taxonomic authority),
  • common name, if applicable,
  • strain and genotype, if relevant,
  • unwanted organisms status – yes or no (see section 3 definitions), and,
  • new organism status – yes or no (see section 3 definitions).

• For unwanted organisms:
  • chief technical officer approval issued by MAFBNZ, authorising the unwanted organisms to be imported.

• For new organisms:
  • HSNO Act approval number issued by ERMA or an IBSC, authorising the new organisms to be imported.

To assist risk assessment MAFBNZ may request additional information.

6. ELIGIBILITY

16.1 The following products may be eligible for import under this standard:

6.1.1 microorganisms that are not new or unwanted organisms,

6.1.2 unwanted organisms, having chief technical officer approval, and,

6.1.3 new organisms, having HSNO Act approval from ERMA or an IBSC.

6.2 Microorganisms that are not new and assessed by MAFBNZ not to be risk goods, or risk goods with a negligible risk, may be given biosecurity clearance provided that all of the following requirements are met:

6.2.1 The consignment is accompanied by a copy of the permit to import, and

6.2.2 All the conditions on the permit to import are met.

6.3 Microorganisms that are not new and assessed by MAFBNZ to be a risk good (including unwanted organisms) may be given biosecurity direction provided the following requirements are met:

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

6.3.2 All the conditions on the permit to import are met, and

6.3.3 The transitional facility listed on the permit to import is approved at the time of import to the MAF and ERMA New Zealand Standard: Facilities for Microorganisms and Cell Cultures 2007a and any subsequent amendments to that standard. This standard is available from the MAFBNZ website http://www.biosecurity.govt.nz/regs/trans/stds.

6.4 Microorganisms that are new organisms may be given biosecurity direction provided the following requirements are met:

6.4.1 The product is accompanied by a copy of the permit to import, listing the HSNO Act approval number,

6.4.2 All the conditions on the permit to import are met,

6.4.3 All the relevant controls and purpose of the HSNO Act approval are met, and

6.4.4 The containment facility listed on the permit to import is approved at the time of import to the MAF and ERMA New Zealand Standard: Facilities for Microorganisms and Cell Cultures 2007a and any subsequent amendments to that standard. This standard is available from the MAFBNZ website http://www.biosecurity.govt.nz/regs/trans/stds.

6.6 Microorganisms 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 MICROORGANISMS

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

8.2 The minimum requirement is for products to be packaged according to Packing Instruction No. 650 of the IATA Dangerous Goods Regulations.

8.3 Microorganisms that fit the definition of a Category A Infectious Substance, as defined in the IATA Dangerous Goods Regulations, must be packaged according to Packaging Instructions No. 602 of the IATA Dangerous Goods Regulations.

8.4 All non-infectious genetically-modified material must be packaged according to Packaging Instructions No. 913 of the IATA Dangerous Goods Regulations.

PART C – BIOSECURITY DIRECTION/CLEARANCE PROCEDURES

9 BIOSECURITY CLEARANCE AND DIRECTION

9.1 Upon arrival of consignments of microorganisms 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 Microorganisms may be eligible for biosecurity clearance pursuant to section 26 of the Biosecurity Act 1993, or biosecurity direction to move to the 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 or containment facility must be operating according to the MAF and ERMA New Zealand Standard: Facilities for Microorganisms and Cell Cultures 2007a and any subsequent amendments to this standard at the time of import.

AI00-50O MICROIC.ALL