The Cartagena Protocol on Biosafety Consultations

Background paper

Executive Summary

The Cartagena Protocol on Biosafety, commonly referred to as the Biosafety Protocol, entered into force on 11 September 2003.  The Protocol deals with environmental issues related to international trade in living (genetically) modified organisms (LMOs)[1], such as genetically modified (GM) seeds, fish, trees and animals.  It aims to provide a framework to help countries make decisions about trade in LMOs with a view to protecting the environment.  The Protocol does not cover trade in processed food or pharmaceutical products using genetically modified organisms (GMOs).

The Protocol has three key elements which will become effective at entry into force: an advance informed agreement procedure, interim documentation requirements and the establishment of an internet site for information exchange about LMOs (the Biosafety Clearing House). 

Issues to be resolved after the Protocol's entry into force include: documentation requirements (handling, transport, packaging and identification); liability and redress (fault and damages); and a compliance regime.

There is no agreement amongst Parties to the Protocol at this stage about how to implement their obligations in detail under the Protocol and individual countries might implement the obligations differently.

In addition, regulation of GMOs is a new and complex area for public policy, and countries are at various stages in determining their approaches.  Some are imposing more stringent requirements on imports of GMOs than foreshadowed by the Protocol.

Australian exporters of LMOs entering into contracts with importers from countries that are Parties to the Protocol should expect to have to comply with domestic laws set by that country in relation to the Protocol or in relation to LMOs more generally.

The Australian Government has no timetable for considering accession to the Protocol.  Nevertheless, the Protocol may impact on Australia as a user, developer, and exporter of GM seed, food or feed. 

Australia has argued in the negotiations to date that the Protocol's provisions should be implemented in a way that is workable, consistent with other international obligations, and achieves its environmental objective without unnecessarily disrupting trade.  Australia has encouraged countries that are putting in place domestic legislation to implement the Protocol, to do so in a way that is consistent with their obligations under the World Trade Organization, and is taking practical measures to help a number of them.  This is important because some of the provisions of the Protocol can be interpreted ambiguously, in particular those dealing with decisions affecting the entry of LMOs.

What is the Biosafety Protocol?

The Cartagena Protocol on Biosafety to the Convention on Biological Diversity was adopted on 28 January 2000.  It aims to deal with environmental issues, taking into account human health, related to international trade in LMOs.  LMOs are genetically modified living organisms, such as GM seeds, fish, trees and animals.  A Party to the Protocol is a country which has formally agreed to be bound by the Protocol. 

A key feature of the Protocol is an advance informed agreement procedure.  This is a prior notification and consent regime for trade in LMOs for direct introduction into the environment, ie for planting or breeding.  Countries which are Parties to the Protocol must be provided with prior written notification and the information necessary to make informed decisions before agreeing to the first import of a LMO.  Annexes to the Protocol specify procedures for risk assessments and detailed information requirements.

The Protocol requires Parties to ensure that documentation accompanying shipments of LMOs that are intended for direct use as food, feed or for processing clearly identifies that they ‘may contain' LMOs and are not intended for direct introduction into the environment. Advance informed agreement provisions do not apply to LMO agricultural commodities destined for food, feed or processing.

To facilitate the exchange of information and experiences on LMOs and to assist countries in the implementation of the Protocol, a publicly accessible, internet-based Biosafety Clearing House was established.  The Biosafety Clearing House will include information on national biosafety risk assessment summaries and final decisions about LMOs.  It will also include information about LMOs that have been approved in particular countries and which may be exported.  It is currently in a pilot phase.

Further information see the Ratification of the Cartagena Protocol on Biosafety Countdown to Entry into force.

The Protocol's entry into force

The Protocol entered into force on 11 September 2003, 90 days after the fiftieth country acceded.  Parties to the Protocol have a number of obligations upon the Protocol's entry into force.  Entry into force of the Protocol means that it has become legally binding within the international legal system.

Parties will be required to implement the advance informed agreement procedure, the interim documentation requirements and the use of the Biosafety Clearing House as outlined above.

There is no agreement amongst Parties to the Protocol at this stage about how to implement these obligations in detail and individual countries might implement the obligations differently.

In addition, regulation of GMOs is a new and complex area for public policy, and countries are at various stages in determining their approaches.  Some are imposing more stringent requirements on imports of GMOs than foreshadowed by the Protocol.  The Protocol's entry into force will pose challenges to those Parties whose regulatory approaches are not well developed. 

Key issues for the first meeting of the Parties

The Protocol leaves a number of key issues for further negotiation and decision after entry into force.  They will be on the agenda for the first meeting of the Parties to the Protocol (MOP-1) which will take place on 23 –27 February 2004 in Kuala Lumpur.  A meeting of the Parties is the highest decision-making forum of the Protocol.

MOP-1 shall consider three specific issues:

• Documentation requirements (handling, transport, packaging and identification);
• Liability and redress (fault and damages); and
• Compliance regimes.

Parties at MOP-1 might also re-introduce issues that have been discussed in the past but not resolved.  These issues include:

• A proposal for a harmonised unique identification system in shipping documentation;
• A proposal for a separate documentation system for the Protocol, in addition to setting standards on documentation and handling requirements; and
• Unintentional presence of LMOs in conventional commodity shipments.

Documentation requirements

As outlined above, at entry into force, each Party shall take measures to require that documentation accompanying shipments of LMOs for food, feed and processing clearly identifies that they 'may contain' LMOs and are not intended for direct introduction into the environment, as well as a contact for further information.  The Protocol requires that a decision on the detailed requirements for documentation, including specification of LMOs and any unique identification, be taken no later than two years after entry into force (by 11 September 2005). 

The Protocol requires that consideration be given to whether there is a need to develop standards for identification, handling, packaging and transport practices for LMOs, in consultation with other relevant international bodies, including Codex Alimentarius, International Plant Protection Convention and the Office International des Epizooties (OIE).

Unique identification

A proposal to create a system of unique identification has been raised in Protocol negotiations in the past.  Unique identifiers involve the establishment of a system with a 9 digit alphanumeric code based on the transformation event, ie the GMO in question, with 2 digits representing the company, 6 digits representing the transformation event and 1 verification digit. 

New global documentation system

The development of a new global documentation system for international trade in GMOs, including with its own emblem, stationary and especially designed form might be proposed.

Standard setting

New detailed documentation requirements and unique identifiers provide the Protocol with scope to become a standards-setting instrument by creating a new international regime for international trade in GMOs.

Unintended presence

There has been little substantive discussion of unintended presence of GMOs in conventional commodity shipments.

Unintended presence, also known as adventitious presence, contamination or co-mingling, refers to the possibility of GM and non-GM grains becoming mixed in the production and distribution chains. 

Liability and redress

The Protocol directs MOP-1 to adopt a process to elaborate international rules and procedures concerning liability and redress for any damage resulting from the transboundary movement of LMOs. In carrying out this action, Parties are to analyse and take due account of the ongoing processes in international law on liability and redress, and shall endeavour to complete this process within four years.

Compliance

MOP-1 shall consider and approve cooperative procedures and institutional mechanisms to promote compliance with the provisions of this Protocol and to address cases of non-compliance. 

Australia's stance

The Australian Government has set no timetable for considering whether to accede to the Protocol due to:

• Concerns about how the Protocol will operate (documentation requirements, and the liability and compliance arrangements which are yet to be agreed);
• Uncertainty about how Parties will implement the Protocol and whether they will do so in a way which respects all of their international obligations, including those under the World Trade Organization;
• Uncertainty about meeting rules under the Protocol and any individual country's capacity to influence decision-making.

For these reasons, Australia will not be a Party at MOP-1 and will not have voting rights, but will be able to participate as an observer.

Australia is actively assessing developments on regulatory approaches to GMOs and the Protocol in key markets.  We have been advocating the need for approaches to be science-based, consistent with the World Trade Organization, and least costly and cumbersome to implement.  We are working with like-minded agricultural exporting countries to maximise our influence.

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