Cartagena Protocol on Biosafety
The Protocol
The Cartagena Protocol on Biosafety (the Protocol) aims to protect biological diversity and human health from the potential risks arising from the import and export of living modified organisms (LMOs). It was adopted by the parties to the Convention on Biological Diversity, and entered into force in 2003. New Zealand has ratified the Protocol.
LMOs include all genetically modified organisms (GMOs) and also organisms produced by the fusion of cells from different taxonomic families.
A main objective of the Protocol is to provide information to importing countries to assist their decision-making when accepting imports of LMOs.
To ensure all countries have ready access to the information they need under the Protocol, an internationally-centralised web-based "Biosafety Clearing-House" mechanism has been set up. In New Zealand, the Environmental Protection Authority (EPA) is responsible for providing the Biosafety Clearing House with the necessary information on New Zealand decisions on LMOs, including information relating to approved exports.
Exporting LMOs
The Imports and Exports (Living Modified Organisms) Prohibition Order 2005 (the Prohibition Order) was passed to enable New Zealand to comply with its obligations under the Protocol.
Exporters must obtain authorisation from the Minister for the Environment before any LMOs can be exported from New Zealand. Anyone who exports an LMO without getting the necessary approval is breaking the law.
Exports of LMOs will only be approved subject to certain conditions. These conditions include: appropriate labelling, handling and packaging; and where necessary, confirmation that approval has been received from the country of import.
Different requirements apply depending on the intended use of the exported LMO in the country of import, eg whether it is intended for use in containment, to be processed, or for release to the environment. The most stringent requirements will be placed on the exports of LMOs intended for release to the environment. This includes risk assessments and prior approval from the importing country.
Information required for LMO exports
For LMOs that are intended for contained use in the country of import, the Protocol requires documentation that:
- clearly identifies the organism as an LMO;
- explains how to handle, store transport and use safely, and
- provides relevant contact details.
For LMOs intended for direct use as food, feed, or for processing in the country of import, the Protocol requires documentation that:
- stating that the shipment 'may contain' LMOs that are not intended for release into the environment; and
- providing a contact point for further information.
For LMOs intended for release into the environment in the country of import, the Protocol requires documentation that:
- clearly identifies the LMO, including its relevant traits or characteristics,
- explains how to handle, store, transport and use it safely;
- provides relevant contact details, and
- provides a declaration that the shipment conforms to the requirements of the Protocol.
For LMOs intended for release into the environment, there is also a requirement to provide the importing country with advance notification before the first export of a particular LMO to any other country that is Party to the Protocol. This allows the importing Party to make an informed decision about whether or not to accept the LMO. The exporter may also be obliged to carry out a "scientifically-sound" risk assessment of the possible adverse effects on biodiversity (including human health) of the LMO. These additional requirements apply only to the first export of an LMO, but subsequent shipments must comply with the documentation requirements. These documents must also include a reference number, provided by the EPA, to confirm the Minister has consented to the export, as is required by the Prohibition Order, and to show that the relevant information has been provided in advance to the Biosafety Clearing House.
Exports of LMOs that are genetically modified organisms (GMOs)
To move GMOs out of (or between) containment facilities within New Zealand needs an approval from MPI by means of their Transfer Request for Cell Cultures, Genetically Modified Organisms and New Organisms form. This form must include EPA's Biosafety Clearing House Reference Number (BCH Record ID) to verify the export has been approved, and must accompany the export during the transfer between containment facilities. Transfers must also comply with any controls imposed by the EPA.
Exports of LMOs that are products of cell fusion
Exporters of LMOs that are the products of cell fusion beyond the taxonomic family are not required to complete an MPI Transfer Request.
However, the documentation accompanying the export (eg customer invoice) similarly needs to include an export approval reference provided by the EPA.
Summary of what is needed:
- The exporter advises MfE of their intent to export an LMO (a GMO from containment or a product of cell fusion beyond the taxonomic family).
- The exporter provides MfE with the relevant details of the nature of the proposed export, the intended country of import and the receiving facility.
- For any LMO export intended for use other than contained use in the importing country, the exporter will need to comply with specific conditions of export pursuant to the Prohibition Order before approval for export will be granted.
- MfE confirm that the export complies with the Protocol and that the Minister has consented to the export.
- The exporter is provided with a reference number confirming the export has been approved (if this approval is not obtained the export cannot proceed).
- The exporter ensures the necessary information is provided on the documentation that will accompany the export (eg a MPI-approved Transfer Request for Cell Cultures, Genetically Modified Organisms and New Organisms form for any GMO, and a customer invoice (or equivalent) for any LMO that is a product of cell fusion).
- The export may proceed following the usual NZ Customs and related export procedures and ensuring adherence to other existing obligations.
Generic Consent given to LMO exports
The Minister for the Environment has granted a Generic Consent to the export of specific LMOs intended for contained use (as defined under the Protocol) in the country of import, provided the exporter meets certain pre-requisite conditions. The conditions for approved LMO exports under the Generic Consent include:
- the LMO being exported must be intended for "contained use". Under the Protocol "contained use" means any operation, undertaken within a facility, installation or other physical structure, which involves LMOs that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment".
- before any LMO can be exported, an authorisation code called the Biosafety Clearing House Reference Number (or BCH Record ID) must be obtained from MfE. This authorisation number confirms the export meets the terms of the generic consent.
- for exported GMOs, the dispatching facility in New Zealand must be a registered Containment Facility approved by MPI Biosecurity New Zealand according to the Biosecurity Act 1993 and Hazardous Substances and New Organisms Act 1996.
- exported GMOs must be accompanied by a Transfer Request for Cell Cultures, Genetically Modified Organisms and New Organisms form that bears the BCH Record ID that has been approved by authorized MPI personnel.
- for exported LMOs that are products of cell fusion beyond the taxonomic family, the BCH Record ID must be noted on the commercial invoice or other equivalent transit document accompanying the export.
The New Zealand Customs Service will use the BCH Record ID to confirm that the LMO export is authorised. It is the exporter's obligation to ensure their export qualifies with the specific conditions of the general consent. Any shipment not properly approved will be subject to seizure and forfeiture. Exported LMOs must also be handled, packaged and transported under conditions of safety and according to relevant international rules and standards.
LMOs not approved for export
The Generic Consent approval described above applies only to exports covered by regulation 6 of the Imports and Exports (Living Modified Organisms) Prohibition Order 2005, namely, LMOs intended for contained use. The approval to export does not apply to the export of any LMO intended for any purpose other than contained use in the country of import, namely, any LMO intended for use for food, feed or for processing, or for release to the environment. These organisms require a specific consent for export from the Minister for the Environment, which will be determined on a case-by-case basis.
Exporters of all LMOs will need to contact MfE at least one working week in advance of the proposed export to ensure their proposed export is covered by the Generic Consent and they can get the necessary export approval (the BCH Record ID). More time may be needed to process applications for exports that are not covered by the Generic Consent and for which specific consent from the Minister for the Environment is needed.
By law, without this approval an LMO cannot be exported.
Importing LMOs
For information on importing LMOs, see the New Organisms section on the EPA’s website.
Further information
For more information on the requirements for exports of LMOs, please contact:
Environmental Protection Authority
Private Bag 63002
Wellington
New Zealand
Telephone: +64 4 918 1489, or email: noinfo@epa.govt.nz
Ministry for the Environment
PO Box 10362
Wellington
New Zealand
Telephone: +64 4 439 7400, or email: info@mfe.govt.nz
Last updated: 21 May 2013
