Science in Society Archive

Biosafety Protocol just Beginning

The Cartagena Protocol on Biosafety regulates genetic engineering. That there is a Protocol at all is remarkable, given the determination of GMO producer/exporter countries and the biotechnology industry to undermine international regulation. Lim Li Lin (Third World Network) and Lim Li Ching outline progress so far and alert us to the challenges ahead.

The year 2000 marked a turning point in global biosafety regulation. The Cartagena Protocol on Biosafety (CPB), the first international law to regulate genetic engineering, was adopted by more than 130 countries. This reflected a global climate of concern about the safety, health and ecological risks of genetically modified organisms (GMOs), and the wider political and socio-economic implications of corporate-driven science and technology.

The Convention on Biological Diversity (CBD), under which the CPB was negotiated, has three fundamental pillars: the conservation of biological diversity, the sustainable use of biological resources, and ensuring fair and equitable sharing of benefits arising from such use. It was opened for signature at the 1992 Earth Summit in Rio.

Even at these early stages, the risks of gene biotechnology were on the agenda. Article 19 (3) of the CBD urges that countries "consider the need for and modalities of a protocol including, in particular, advance informed agreement in the field of the safe transfer, handling, and use of any living modified organism resulting from biotech that may have an adverse effect on the conservation and sustainable use of biodiversity".

The Jakarta Mandate to begin negotiations on a legally binding biosafety protocol arose from the second CBD Conference of the Parties in 1995.

Negotiations on the CPB concluded in January 2000 in Montreal. To-date more than 100 countries are signatories, but only 10 have ratified the protocol, far short of the 50 required for the CPB to enter into force. Of the countries that have ratified, the majority are developing countries.

The negotiations were very difficult and divisive; although scheduled to conclude in February 1999 in Cartagena, Colombia, the talks collapsed. The US-led Miami Group (comprising also of Canada, Australia, Argentina, Chile and Uruguay – the major producers of GMOs and allies) blocked agreement on provisions on the movement of genetically engineered commodities for food, feed or for processing, which would have required the prior informed consent of the importing Party. These commodities are the bulk of traded GMOs, and the Miami Group was determined that they should be excluded from the CPB.

Conversely, developing countries felt very keenly the need to have an internationally binding legal instrument on biosafety that would regulate the movement of all GMOs between countries. During the negotiations, most had consolidated into a negotiating bloc known as the ‘Like-Minded Group of Developing Countries’. As importers of GMOs, and as countries most vulnerable to their ecological and socio-economic impacts, they presented a united front.

Most developing countries have no laws or regulations on biosafety and lack the capacity, and technological and financial resources to regulate genetic engineering. As public rejection of GMOs in Europe and other parts of the world gathered momentum, the fear of becoming a dumping ground for unwanted and untested GMOs was real. It was thus imperative to place the onus on exporting countries to seek the prior informed consent of importing countries, instead of simply allowing GMOs to pass unregulated through the global market. Furthermore, mounting scientific evidence of hazards coupled with revelations of flawed approval systems in producer countries highlighted the urgent need for international regulation.

Significance of the CPB

When agreement finally came in Montreal, the result was a Protocol with a heavily negotiated text, which left some serious flaws and loopholes. Despite the compromises, the CPB is still a remarkable achievement, considering that the Miami Group, under the influence of the biotech industry, did not want a protocol on biosafety and strongly resisted it, attempting to water it down so as to render it meaningless.

The CPB addresses the fact that GMOs may have adverse effects on the conservation and sustainable use of biodiversity, and also on human health. For the first time in international law, GMOs are recognised as inherently different, carrying special risks and hazards, and hence need to be regulated internationally. This essentially unseats the flawed regulatory mechanism of ‘susbstantial equivalance’ that is sometimes used, in effect, to (de)regulate GMOs.

The CPB establishes the foundations of international law on the regulation - primarily of the transboundary movement - of GMOs. While many aspects of biosafety regulation are best addressed by national legislation, aspects relating to transboundary movement are difficult to regulate domestically. An international law is therefore necessary.

The Precautionary Principle (i.e. in the absence of scientific certainty, a party should err on the side of caution and restrict or ban the import of GMOs on account of their potential adverse effects) has also been reaffirmed and put into operation in the CPB decision-making procedures.

Major unresolved issues are highlighted below.

Scope of the Protocol

The CPB regulates genetic engineering biotechnology, not biotechnology in general. It covers ‘living modified organisms’ (LMOs), not ‘genetically modified organisms’. This was contentious as such a narrow definition excludes non-living modified organisms, potentially excluding all GMOs except those intended for growing in fields. And products derived from GMOs such as processed and unprocessed food and food additives would not be included, despite the fact that inserted genetic material can persist in the products, can survive passage through the gut, and enter into cells via the bloodstream. (In this article, we use ‘LMOs’ only in reference to the Protocol).

The CPB primarily regulates the transboundary movement - export and import, movement between countries - although its scope extends to the transit, handling, and use of LMOs. The battle to have a comprehensive scope was crucial, as all GMOs carry the same risks and hazards, whether living or not, and regardless of whether they are used in agriculture, medicine or research, or classified as commodities or pharmaceuticals. The coverage of GE pharmaceuticals (e.g. genetically engineered vaccines), LMOs in transit and for contained use, is also unsatisfactory.

Advanced Informed Agreement

The Advanced Informed Agreement (AIA) procedure forms the ‘backbone’ of the Protocol. It is a procedure for obtaining prior informed consent from the importing Party before a LMO crosses national boundaries. The onus is on the exporting Party to notify and furnish relevant information to the importing Party. The latter will then make a decision based on risk assessment and the Precautionary Principle.

But there are many qualifications and limitations to its application.

Other important provisions unresolved

The Protocol has provisions for identification and segregation, trade with non-parties, relationship with other international agreements, socio-economic considerations, liability and redress, risk assessment, risk management, review of decision, unintentional and illegal transboundary movement of LMOs, information sharing, capacity building, public awareness and participation. But none of these are clearly resolved.

For example, LMOs for direct use for food, feed or processing need only be identified as ‘may contain’ LMOs, in effect, not requiring mandatory segregation. Liability and redress for damage resulting from the transboundary movement of LMOs is to be worked out within four years after the Protocol comes into force. And although socioeconomic considerations can be taken into account when making import decisions, this is qualified by reference to consistency with other international obligations.

National legislation essential

The most important feature of the Protocol is that it sets minimum standards for the regulation of LMOs - Parties may take action that is ‘more protective of the conservation and sustainable use of biological diversity than that called for’ in the Protocol. While strengthening the Protocol and rectifying its deficiencies should be the long-term goal, it is critical that national governments, and developing countries in particular, formulate domestic biosafety laws that improve on the Protocol’s scope and standards.

Many have already established, or are establishing, strict and comprehensive biosafety regulation, for example, EU biosafety rules and policy (see ISIS News 11/12), the Organisation of African Unity model law on safety in biotechnology, and national biosafety laws in Norway, Denmark and Sweden.

Capacity building is crucial

Capacity has to be built in developing and developed countries alike for comprehensive national biosafety regulation, scientific expertise, and monitoring and enforcement capabilities (see Box). This requires real commitment, in terms of providing financial resources and speedy implementation of initiatives.

The Biosafety Protocol is thus just the start of the long, difficult road to international regulation of genetic engineering.

For more details, please visit the Third World Network website:

I-SIS News 13 index

Article first published February 2002

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