Jun 20, 2003

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Biosafety Protocol enters into force

On 13 June the small Pacific nation of Palau became the fiftieth state to ratify the Cartagena Protocol on Biosafety. This triggered a 90-day period after which the international agreement will automatically enter into force. This means that the provisions of the Biosafety Protocol concerning the export of genetically modified organisms (GMOs) will take effect on 11 September this year.

The Protocol on Biosafety, also called the Cartagena Protocol after the last place negotiations were held, is the first international agreement to set internationally binding rules on transboundary trade in living genetically modified organisms.

A good three years after negotiations were completed, the agreement can now enter into force. On the occasion of the 50th ratification, the Executive Director of the UN Environment Programme (UNEP), Klaus Töpfer, declared, “The Cartagena Protocol recognises that biotechnology has an immense potential for improving human welfare but that it could also pose risks to biodiversity and human health.”

The former German Environment Minister is convinced that the provisions of the Biosafety Protocol will make international trade in GMOs more transparent. Important safety measures had been introduced to meet the requirements of consumers, industry and the environment, Töpfer explained. At the same time, he emphasised that “avoiding potential conflicts between trade laws and the biosafety regime will require good will and careful management”.

WTO and Cartagena

Here Töpfer was alluding to the as yet unanswered question of what status the Biosafety Protocol will have in relation to other trade law regulations, e.g. the World Trade Organisation (WTO) Agreement on Sanitary and Phytosanintary Measures. The Cartagena Protocol is not an international standard in the sense of the SPS Agreement. Whether import restrictions on GMOs can be supported by the Biosafety Protocol under international law is unclear.

In addition, the USA, which is the greatest exporter of genetically modified products, has not signed the Cartagena Protocol. Töpfer therefore gave a reminder that coordination between the various international systems should to be improved. This would considerably strengthen biosafety, avoid potential conflicts and harmonise the legitimate interests of trade, biosafety and other sectors.

The signatory states will be discussing the practical implementation of the Cartagena Protocol in the first quarter of 2004 in Kuala Lumpur, Malaysia, at the first meeting of the parties.

Information flow and decision-making sovereignty: the key points of the Protocol

When the Cartagena Protocol was signed in January 2000 after difficult negotiations, it won approval both from anti-biotech environmental groups and from industry and research associations.

The key points of the Protocol on Biosafety are:

• When living genetically modified organisms are to be exported to another country, with the aim of being released into the environment, a special “advanced informed agreement procedure” must be followed.
• The exporting country has an obligation to make accessible to the receiving country all the information required for a safety assessment. The importing country can ban the import if there are plausible doubts about its safety for the environment, biological diversity or human health. Unlike the WTO agreement rules, no scientific evidence is required to justify a ban. The Protocol therefore allows states to impose import bans as a precaution.
• This procedure does not apply to the trade in genetically modified organisms such as soya beans or maize that are to be immediately processed into food or feed in the importing country.
• The exporting countries undertake to make available all safety-related information to an international clearing-house. Importing countries can use this where necessary.
• For trade in GMOs intended for release, the agreement of the importing country is necessary in all cases – but not for the export of GMO products if no release is planned. However, the exporting country is responsible for ensuring that the receiving country has access to all safety-related information and findings.
• An international Biosafety Clearing-House has been set up to organise the information flow agreed in the Protocol for Biosafety. Germany now also has a national clearing-house within the system.