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.
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.
For LMOs that are intended for contained use in the country of import, the Protocol requires documentation that:
For LMOs intended for direct use as food, feed, or for processing in the country of import, the Protocol requires documentation that:
For LMOs intended for release into the environment in the country of import, the Protocol requires documentation that:
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.
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.
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.
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 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.
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.
For more information on the requirements for exports of LMOs, please contact:
Environmental Protection Authority
Private Bag 63002
Telephone: +64 4 918 1489, or email: firstname.lastname@example.org
Ministry for the Environment
PO Box 10362
Telephone: +64 4 439 7400, or email: email@example.com
Last updated: 21 May 2013