Cartagena Protocol on Biosafety
Information for exporters on implications of NZ's Ratification
New Zealand has ratified the Cartagena Protocol on Biosafety (the Protocol), a multinational agreement, set up under the United Nations Convention on Biological Diversity, to regulate international trade of living modified organisms (LMOs).
Under the Protocol LMOs include all genetically modified organisms (GMOs) and 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 Risk Management Authority (ERMA) 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 Protocol entered into force for New Zealand on 25 May 2005, when new requirements came into effect that must be met before any LMOs can be exported.
No change for imports and domestic use
Becoming a Party to the Protocol does not impact on the import or domestic use of LMOs.
New Zealand already has rigorous controls in place, under the Hazardous Substances and New Organisms Act 1996 (HSNO) and the Biosecurity Act 1993, covering the import and domestic use of GMOs. These will not change.
Products of cell fusion are not regulated under HSNO - they are specifically excluded under the Hazardous Substances and New Organisms (Organisms Not Genetically Modified) Regulations 1998. This also will not change.
New requirements for LMO exports from 25 May 2005
From 25 May 2005 there have been new obligations for exporters of LMOs.
The Protocol requires New Zealand to regulate the export of LMOs, that is, both GMOs (as defined under HSNO) and the products of cell fusion beyond the taxonomic family.
The Imports and Exports (Living Modified Organisms) Prohibition Order 2005 (the Prohibition Order) was passed to enable New Zealand to comply with this obligation.
The Prohibition Order came into effect from 25 May 2005, from which date consent from the Minister for the Environment is needed before any LMOs can be exported from New Zealand. Anyone who exports an LMO without getting the necessary approval would be breaking the law. Exporters therefore need to get an authorisation to export - available by contacting either ERMA or the Ministry for the Environment.
Requirements for exports under the Prohibition Order
Under the Prohibition Order exports of LMOs are only allowed subject to certain conditions to ensure that the Minister is satisfied that New Zealand's obligations under the Protocol are complied with. 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, including a need for risk assessments and prior approval from the importing country.
From 25 May 2005, anyone proposing to export an LMO needs to provide ERMA with information on the nature of the organism being exported, and get formal confirmation that the export has been approved by the Minister, before the LMO can leave the country. There is a legal requirement for exporters to provide accurate information in relation to exports covered by the Protocol.
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.
Documentation requirements for LMO exports
Exporters of LMOs must provide similar documentation to that required under the Prohibition Order, eg customer invoices and Ministry of Agriculture and Forestry (MAF) Transfer Requests.
However, since 25 May 2005, such documents must also include a reference number, provided by ERMA, 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)
Any person wishing to import, develop or field test in containment, or release a GMO in New Zealand requires an ERMA approval under HSNO. No releases have been approved, meaning all approved GMOs are currently held in MAF/ERMA registered containment facilities.
To move GMOs out of (or between) containment facilities within New Zealand needs an approval from MAF by means of their Transfer Request (Genetically modified organisms) form. Transfers must also comply with any controls imposed by ERMA and the Transfer Form must accompany the GMO during transfer between containment facilities.
From 25 May 2005, the MAF Transfer Form must also include ERMA's
Biosafety Clearing House Reference Number (BCH Record ID) to verify the
export has been approved. No additional documentation is required, other than what would routinely accompany the export.
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 a MAF Transfer Request.
However, the documentation accompanying the export (eg customer invoice) similarly needs to include an export approval reference provided by ERMA. Again, no additional documentation will be required other than what would routinely accompany the export.
Summary of what is needed before LMOs can be exported
By adapting existing practices, compliance requirements have been made as easy as possible with minimal changes in compliance costs. However, anyone proposing to export any LMO who is unsure what is required should contact ERMA or the Ministry for the Environment to confirm what is needed.
The following provides a summary of what exporters must do, from 25 May 2005, before an LMO can be exported:
- The exporter advises ERMA or the Ministry for the Environment of their intent to export an LMO (a GMO from containment or a product of cell fusion beyond the taxonomic family).
- The exporter provides ERMA with the relevant details of nature of proposed export, the intended country of import and the receiving facility.
- For any LMO export intended for 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.
- ERMA and the Ministry for the Environment confirm that the export complies with the Protocol and that the Minister has consented to the export.
- ERMA lodges the relevant information of the Biosafety Clearing House.
- 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 MAF-approved Transfer Request (Genetically Modified and New Organisms) 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 specific 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 living modified organisms 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 ERMA. 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 MAF 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 (Genetically-modified and new organisms) that bears the BCH Record ID that has been approved by authorized MAF 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 ERMA 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 can not be exported.
Exporters should contact ERMA or the Ministry for the Environment directly for further detail on exports covered by the generic consent and the information that needs to be provided to gain approval for any other LMO exports other than those covered by the generic consent.
Other existing domestic procedures remain unchanged
Exporters should note that the procedures detailed above relate directly to processes put in place to enable exporters of LMOs to comply with their specific obligations under the Imports and Exports (Living Modified Organisms) Prohibition Order 2005. These requirements are in addition to any existing obligations on exporters to ensure they adhere to the requirements of countries of import, and any existing domestic legislative or regulatory provisions covering the export of organisms from New Zealand .
For example, the export of live animals and animal germplasm must be carried out in accordance with the established protocols of the MAF Biosecurity Exports Group.
Under the Animal Products Act 1999, live animals and animal germplasm (semen and embryos) exported for commercial reward must be exported by registered exporters. Exporters must ensure that there are established overseas market access requirements (OMARS) for the export of these animals/animal germplasm. Exporters should contact MAF Biosecurity Exports Group to discuss intended exports well in advance of the proposed date of export.
Additionally, for all live animal exports an animal welfare export certificate is required. Please contact the NZFSA Verification Agency for further information.
Please note that this is not a complete list of obligations for exporters and additional requirements will need to be met depending on the nature of the particular export.
In all cases, prospective exporters should contact their customs broker or the NZ Customs if they are unclear of their responsibilities.
Further information
If you need more information on the requirements for exports under the Cartagena Protocol or the Prohibition Order, please contact:
The Environmental Risk Management Authority (ERMA New Zealand)
PO Box 131, Wellington, New Zealand
Telephone: +64 4 916 2426, or email: info@ermanz.govt.nz
or
The Ministry for the Environment
PO Box 10362 , Wellington New Zealand
Telephone: +64 4 439 7400, or email: information@mfe.govt.nz
Last updated: 12 March 2008
