Annex I: Definitions

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.

Annex II: Risks and hazards of genetic engineering biotechnology

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

Hazards from new genes and new gene products introduced

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.

Unintended effects inherent to the ‘technology’

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.

Hazards from the uncontrollable spread of the introduced gene

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.

Annex III: Case study

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.

· GM contamination

-         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

· Testing, segregation and identification

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

-         No testing of the seed was done by the importer

· Liability

-         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? 

· Dumping

-         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?