Capacity Building and the Biosafety Protocol: A TWN report


By Lim Li Lin, Third World Network


The Biosafety Protocol is very important, particularly for developing countries, for many reasons. It is an international law that regulates genetically modified organisms (GMOs). This is a recognition of the fact that GMOs are inherently different and carry special risks and hazards, and hence need to be regulated internationally. Countries always had the sovereign right to regulate GMOs and their products at the national level; the Protocol now establishes an internationally binding framework of minimum standards.

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

Developing countries are and will continue to be the prime importers of GMOs and products derived from GMOs, which are exported primarily from the North. Public rejection in the North of GMOs and their products means that increasingly, markets are being sought for GMOs and their products in developing countries. And most developing countries do not yet have national biosafety laws or regulations. Developing countries also face an even greater environmental risk than countries of the North because most of the global centres of crop origin and diversification are located in the South.

The Precautionary Principle has been reaffirmed and operationalised in the decision-making procedures in the Protocol. This means that in the absence of scientific certainty, Parties should err on the side of caution and ban or restrict the import of the GMOs on account of its potential adverse effects. The sound reaffirmation of the Precautionary Principle in the Protocol also further establishes this Principle as a principle of international law.


However, the Protocol, though significant, was a heavily negotiated text and is riddled with many deficiencies. Many categories of GMOs have been excluded from the general scope of the Protocol and from the prior informed consent procedures. But the risks from all GMOs are the same, whether they are used in agriculture, medicine or research, and regardless of whether they are classified as commodities or pharmaceuticals.

Products derived from GMOs (e.g. soy proteins, a product of transgenic soya beans) are excluded entirely from the general scope of the Protocol. As such, products derived from GMOs remain unregulated internationally. But naked DNA, which is the genetic material inserted into the recipient organism, subsists in the products derived from GMOs and has been shown to survive passage through the gut and can enter the blood stream.

The Protocol also does not apply to the transboundary movement of genetically engineered pharmaceuticals for humans that are addressed by other ‘relevant international agreements or organisations’.

The bulk of GMOs are excluded from the advance informed agreement (AIA) procedure. The AIA procedure requires that potential importers of GMOs are first notified and furnished with relevant information. This triggers a process of decision-making based on risk assessment and the Precautionary Principle. While GMOs for food, animal feed or processing are clearly within the general scope of the Protocol, they are excluded from the AIA procedure. These form the bulk of traded GMOs – around 90% of the main GMO exporters’ exports (e.g. soya, canola, maize).

Likewise, GMOs that are destined for contained use (the Protocol defines contained use as specific measures that limit the contact and impact of GMOs on the external environment) and GMOs in transit (i.e. that are passing through the territory of a third party) are also excluded from the AIA procedure.


The Protocol only sets the international framework for the regulation of GMOs, in particular the transboundary movement of GMOs. It must be implemented at the national level; indeed, Parties have an obligation under the Protocol to do so. In order to properly and effectively implement the Protocol, a few key requirements are critical. A potential importer must be aware of the fact that a particular GMO is likely to enter into its territory, and must also be able to assess its potential risks and hazards in order to make a decision.

In other words, to effectively implement the Biosafety Protocol in line with its objectives1 and provisions, a country must have the following:
1. Full knowledge that GMOs will be crossing its national boundaries; and
2. Ability to assess the safety or otherwise of GMOs and make a decision either to ban or import the GMOs with or without conditions.


The ‘backbone’ of the Protocol is the advance informed agreement (AIA) procedure which regulates the transboundary movement of GMOs. It requires the exporting Party to obtain the prior informed consent of the importing Party before GMOs can cross national boundaries. The exporting Party must first notify the importing Party that it intends to export GMOs to the other Party. The obligation to notify thus lies with the exporting Party. This should have ensured that countries would be fully aware of any GMOs that will be entering into its territory.

However, many categories of GMOs are excluded from the AIA procedure, and some categories of GMOs are even excluded entirely from the general scope of the Protocol. Only the first intentional transboundary movement of GMOs for intentional introduction into the environment of the Party of import (e.g. for planting, field testing) will be subject to the AIA procedure. This means that subsequent exports will not be subject to the AIA procedure. This is severely lacking as on account of the uncontrollable, random nature of the genetic engineering process, each transgenic line will be distinct, even though the same materials, gene-constructs and vector systems are used. Also, because of the inherent instability of the transgenic lines, further changes may occur during cultivation, so that, in effect, the properties will become quite different from the originally approved line.

GMOs intended for direct use for food, feed or for processing, which form the bulk of traded GMOs, are excluded from the AIA procedure, and a different mechanism applies. Once domestic approval has been given for any GMOs for food, feed or for processing that may be traded internationally, the approving Party must make this information available to the Biosafety Clearing House. (The Biosafety Clearing House is basically a website administered by the Secretariat to the Convention on Biological Diversity.)

This is basically the extent of the obligation of the potential exporting Party. A country cannot even be sure if the GMOs will be shipped into its territory, but will have to initiate procedures for assessing whether or not the GMOs should be admitted into its territory. In other words, a domestic approval by one Party shifts the onus onto all other countries to decide whether or not they will accept the GMOs, when countries do not even know whether the GMOs will even be exported to their country.


To decide on whether or not to import a GMO, Parties will base their decision on risk assessment and the Precautionary Principle. Socio-economic considerations can also be taken into account, but this provision is qualified. This consideration is however of particular importance to developing countries.

The information that must be provided as a minimum, along with the notification by the exporting Party that it intends to export the GMO, is listed in an annex to the Protocol. This information includes a risk assessment. This risk assessment will be furnished by the exporting Party. The importing Party must evaluate the risk assessment in order to make an informed, scientific decision.

One of the difficulties here lies with the issue of conflict of interest – the risk assessment would have been conducted by or commissioned by the exporter. Another difficulty lies with whether or not the information provided by the exporting Party is sufficient for the importing Party to assess the safety of the GMOs. The Protocol only specifies the minimum information required. The exporting Party is therefore under no obligation to provide more than the minimum information required. For imports of GMOs for food, feed or processing, the minimum information that the exporting Party has to supply is even less than that required for the other categories of GMOs.

The information required to be supplied as a minimum and the specifications for risk assessment that are provided for in the Protocol do not properly take into account the molecular genetic characterisation data that indicates the stability of the transgenic line. This information is crucial for a number of reasons. Failure to supply informative data on these characterisations will mean in practice that unstable lines may be approved, which will change its characteristics in successive generations of growth; or multiple transgenic lines, all with different characteristics may be released after a single cell line has been approved. This data is also crucial for risk assessment and risk management, and for identification and traceability when considering liability.

Thus, these two considerations form the backdrop and the context for considering the main areas for capacity building in developing countries.


Translated into the national operative framework, countries and developing countries in particular need to build up their capacity on three key fronts: biosafety regulation, scientific capacity, and monitoring and enforcement capabilities.


Clearly the Biosafety Protocol has its shortcomings. However, all these can and should be made good by national biosafety legislation. The Protocol sets down minimum standards. This is explicitly recognised in the Protocol. Parties may take action that is ‘more protective of the conservation and sustainable use of biological diversity than that called for’ in the Protocol.

The best way to ensure that obligations under the Protocol are effectively implemented is to enact national biosafety legislation. This will have the force of law and its implementation can be backed by punitive measures. There are also many aspects of biosafety regulation that are not addressed by the Protocol and which can be best addressed by domestic regulation. Comprehensive national legislation will also ensure that the unique risks and hazards of GMOs are fully taken into account and regulated specifically and appropriately.
Parties are obliged to implement their obligations under the Protocol. In order to do so effectively, countries require comprehensive national biosafety legislation. While the strengthening of the Protocol and rectification of its deficiencies should be the long-term goal, developing countries should work towards strengthening the biosafety regime within the national framework.

The Protocol is not comprehensive in scope, does not address all aspects of biosafety regulation, and covers only some aspects of transboundary movement of GMOs. National biosafety legislation must strive to fill the gaps in the Protocol to ensure the highest standards of biosafety, based on the Precautionary Principle.

Key elements in national biosafety legislation which would plug the gaps in the Protocol and ensure tighter biosafety regulation would include requiring approvals for all activities relating to all GMOs and their derived products on a case by case basis. Approvals should also be required for every stage of GMO development – from research in contained conditions to field trials, and to full-scale releases into the environment. In addition to risk assessment, a cost-benefit analysis should also be conducted to determine if there is even a need for the GMOs, and if there are sustainable or safer alternative technologies.

The formulation of national biosafety legislation must benefit from an open and participatory process. Given the volume and strength of worldwide public disquiet and consumer opposition towards genetic engineering biotechnology, a national process that is transparent, accountable and which involves all levels of public participation is crucial.


Once a biosafety regulatory system is in place, countries will need to be able to make decisions on applications to export GMOs to its country. The decision-making body must have the backing of local scientific capacity to screen applications and make decisions on import. The training and capacity building of local scientists in biosafety assessment is therefore critical. Government scientists, university scientists, scientists from research institutions and scientists from civil society organisations should all be part of the local scientific pool of expertise.

The scientific body may have to do a number of things. Most importantly, it will have to evaluate the risk assessment submitted by the exporting Party as part of the information supplied along with the notification to the importing Party. It could also conduct its own risk assessment or instruct the exporting Party to undertake another risk assessment if it is not fully satisfied with the risk assessment supplied by the exporting Party.

In the light of new scientific information about potential adverse effects, the importing Party can review its decision. Where a change in circumstances has occurred that may affect the outcome of the risk assessment, or additional scientific information has become available, the exporting Party may request the importing Party to review its decision. All this requires scientific biosafety capacity.

It is advisable that the scientific body should not also comprise of scientists from industry because of the inevitable conflict of interest.


There has to be an effective national monitoring and enforcement capacity. The best laws, regulatory mechanisms, and scientific expertise will be of little use if there is no effective monitoring and enforcement capability to ensure sound biosafety regulation.

Monitoring and enforcement has to take place on a few levels. Firstly, scientific developments globally have to be tracked and monitored from day to day. New scientific evidence of actual and potential risks of genetic engineering biotechnology and of the food, crops, pharmaceuticals, etc. is constantly emerging. These developments in the scientific arena must be closely followed and considered in risk assessment and risk management. New scientific information is also a basis for the decision-making body to review its decision.

Secondly, countries must be on the alert for GMOs that may slip through the regulatory process and enter into the country inadvertently. This will entail an extremely vigilant customs at all entry points into the country.

Countries also need to be aware of other means by which GMOs could inadvertently pass through their borders. This could be through foreign agencies providing bilateral aid and food aid. A substantial part of food aid could comprise of genetically engineered seeds and food. The growing consumer rejection of genetically engineered foods in Europe, and which has now spread to North America, is giving rise to concerns that excess and unwanted genetically engineered seeds and food would be dumped on developing countries. This could bypass the procedures and mechanisms for regulating the transboundary movement of GMOs.

An article on 30 March 2000 in the London Independent reported that the US Department of Agriculture is exporting hundreds of thousands of tons of genetically engineered maize to the Third World through the United Nations and American aid agencies. According to the article, American farmers who are facing a rejection of their genetically engineered crops are left with one unquestioning market – emergency aid which is the last unregulated export market open to the US farmers.

This is unfairly taking advantage of a country’s urgent needs, and violates the spirit and tenor of the Protocol. It undermines all that developing countries had fought so hard for in the Protocol negotiations. Countries in crisis should not have to be faced with the dilemma between allowing their people to starve to death and allowing their genetic pool to be contaminated and potentially hazardous food to be fed to their populations. Aid programmes and international agencies should be prohibited from including genetically engineered food, seeds and crops in their aid or projects.

All this implies that countries will also require some means of testing or access to testing facilities to find out whether or not an organism is genetically engineered. This is particularly relevant in the light of the GMO scandal that hit Europe in May 2000, where 11,600 acres of farm land were found to be planted with GM-contaminated oil seed rape.


1. Governments must sign and ratify the Cartagena Biosafety Protocol as soon as possible in order for it to come into force.
2. A national committee must be set up to formulate national biosafety legislation that meets the minimum requirements of the Biosafety Protocol and goes beyond that to provide for comprehensive biosafety regulation and a stricter national biosafety regime.
3. An approvals committee must be set up that will have the backing of local scientific expertise, and should comprise also of representatives from civil society organisations and exclude industry representatives.
4. Effective monitoring and enforcement mechanisms must be established.
5. Capacity for further negotiations must still be built up. The interpretation and implementation of the Biosafety Protocol will be an on-going process. There are also provisions in the Protocol e.g. liability and redress, and segregation and identification of GMOs for food, feed or processing which still have to be finalised.
6. Monitor developments in other fora that could undermine the Protocol (e.g. World Trade Organisation agreements) or which could be used to strengthen the Protocol.

(1) The objective of the Biosafety Protocol (Article 1): ‘In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements.’


The term ‘biotechnology’ is used very loosely, often to describe a plethora of applications. Many a time, this results in confusion over what is being specifically being referred to, and what is being specifically critiqued. ‘Biotechnology’ refers to methods and techniques which can range from the production of cheese and yoghurt to the production of crops and seed with new genes introduced for specific traits.

The Cartagena Protocol on Biosafety, however, is clear on this point. It seeks to regulate ‘living modified organisms’, more commonly known as ‘genetically modified organisms’ or ‘genetically engineered organisms’ produced by ‘modern biotechnology’.

‘Modern biotechnology’ refers to ‘genetic engineering’, ‘genetic modification’ or ‘genetic manipulation’ which produces these novel organisms. It is a significant departure from traditional methods, and introduces significant differences. Genetic engineering bypasses reproduction altogether. It transfers genes horizontally (as opposed to vertically, from parent to offspring), often making use of artificially constructed vectors (carriers of genes) so that genes can be transferred between distant species that would never interbreed in nature. For example, human genes are transferred into pig, sheep, fish and bacteria. Completely new and exotic genes are being introduced into food crops and pharmaceuticals.

‘Technology’ is derived from the Greek term ‘tekhne’ which is connected to handicraft or the arts. The term is associated with predictability, control and reproducibility. Current methods of genetic engineering have been critiqued by some scientists as not deserving the label ‘technology’. This is because genetic engineering is hit or miss and not at all precise, as it depends on the random insertion of the artificial vector carrying the foreign genes into the genome.

The term ‘risk’ is often confused with probability. ‘Risk’ is the probability or likelihood that something will take place multiplied by the effects that arise if it takes place. In other words, something may have a small chance of happening, but if the consequences of it happening are catastrophic, the risk is immense. A nuclear disaster is a good case in point.


The main sources of hazards and problems of genetic engineering biotechnology can be classified in the following ways:


New genes and gene products are introduced into our food, often from bacteria and viruses and other non-food species that we have never eaten before, and certainly not in the quantities produced in genetically engineered crops, where they are typically expressed at high levels. The long term impacts of these genes and gene products on human health will be impossible to predict, particularly as the products are not segregated and there is no post-market monitoring.

GM crops with bt-toxins kill beneficial insects such as bees and lacewings, and pollen from bt-maize is found to be lethal to Monarch butterflies. New research shows that bt-toxin is exuded from the roots of bt-plants, where it binds to soil particles and becomes protected from degradation. As the toxin is present in an activated, non-selective form, both target and non-target species in the soil will be affected.


Genetic engineering is not precise and depends on the random insertion of the artificial vector carrying the foreign genes into the genome. This random insertion is well known to have many unexpected and unintended effects including cancer, in the case of mammalian cells. Furthermore, the effects can spread very far into the host genome from the site of insertion.

Unintended effects from the interactions between foreign genes and host genes
No gene functions in isolation. Among the unintended effects relevant to food safety are new toxins and allergens, or changes in concentrations of existing toxins and allergens. A Brazil nut allergen was identified in soya bean genetically engineered with a Brazil nut gene which was not thought to be allergenic.


Genetic pollution, as opposed to chemical pollution, cannot be recalled. Genes, once released, have the potential to multiply and recombine out of control either through cross-pollination or horizontal gene transfer. Particularly serious consequences are associated with the potential for horizontal gene transfer. These include the spread of antibiotic resistance marker genes that would render infectious diseases untreatable, the generation of new viruses and bacteria that cause diseases, and harmful mutations which may lead to cancer.

The UK Ministry of Agriculture, Fisheries and Food has admitted that the transfer of GM crops and pollen beyond the planted fields is unavoidable and this has already resulted in herbicide tolerant weeds. Bt-resistant insect pests have evolved in response to the continuous presence of the toxins in GM plants throughout the growing season, and the US Environment Protection Agency is recommending farmers to plant up to 40% non-GM crops in order to create refugia for non-resistant insect pests.


In May 2000, news broke that 11,600 acres of oilseed rape in Europe were inadvertently planted with GM-contaminated seeds. The company involved in growing, preparing and selling the seeds to the farmers in Europe, Advanta Seeds in Canada, had grown conventional seeds, but the final product was found to have contained GM material, believed to have come from GM crops growing 800 meters away.

This raises a number of serious issues which are relevant to the strengthening of the Biosafety Protocol, its implementation, and to the consideration of capacity building of developing countries for national biosafety implementation.

– How did the seed become contaminated? Through cross-pollination from GM crops growing nearby and/or horizontal gene transfer?
– Possibility of further contamination of crops in Europe due to the growing of the GM-contaminated oilseed rape

– No testing, segregation or identification of the seed was done by the exporter
– No testing of the seed was done by the importer

– If the crops are destroyed, who is liable for compensating the farmers growing the contaminated seed?
– If the crops are not destroyed, who is liable for compensating the farmers when they are unable to sell their harvest?
– If the crops are not destroyed, who is liable for compensating the consumers if there are negative effects from consuming the contaminated oilseed rape?
– Who is liable for compensating other farmers in Europe whose non-GM crops nearby run the risk of further contamination?

– If the crops are not destroyed and farmers are unable to sell their harvest, will they be dumped on developing countries, either through export or food aid?

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