The expanding field of biotechnology has relevance to everybody, – with its risks and benefits. In common with all emerging technologies it is associated with a high degree of uncertainty. Trust and confidence will therefore be key words. DNV is now developing bio-risk assessment services.
The field of biotechnology is rapidly expanding, and new aspects of risks and benefits will continually emerge. While academia and industry are exploiting the latest technology as they compete to come up with pioneering and innovative products, the public at large is sceptical to the possible consequences. This public uncertainty is amplified due to the lack of trust and confidence facing governments and regulators in many of the developed countries.
‘‘There is still so much unknown in nature,’’ says the highly profiled Sissel Rogne, Director General of the Norwegian Biotechnology Advisory Board. She has been a professor in biotechnology since 1992 and has her education from London on studies in gene technology.
‘‘All use of new technology has to be done cautiously. It is important to try to take the unexpected into account’’ she says acknowledging DNV’s experience within environmental risk assessment as the company now develops risk assessment services within the field of biotechnology.
One very exciting but contentious technology is the introduction of genes from one organism into a second unrelated organism. So called genetically modified organisms are already utilised within many fields including food, forage, textiles and medicine. Many of the modified organisms have characteristics that are sought-after, and a wide range of biotechnology companies are therefore now selling products based on gene modified organisms.
‘‘Within the food area, the most important areas for gene modified organisms is crops which contain additional genes that give plants that are more robust, have improved disease resistance, better nutritional value, better taste, consistence or appearance,’’ Sissel Rogne explains.
Increasing Demand
The worldwide approach to legal regulation of this field has been fragmented. The different countries have different traditions within legislation development, customs and culture. However, international biotechnology agreements and conventions have been signed after the world summit on sustainable development in Rio 1992.
‘‘The world is now witnessing the beginning of an international harmonisation of rules and regulations, which would be beneficial,’ she says. Norway has all the way been cautious in its approach. ‘Now we’re beginning to see that the rest of the world tends to share our approach,’’ she says.
So far, no gene modified food products have been approved by the Norwegian government, but such products have been available in the U.S.A. and some European countries since the late nineties, and gene modified plants are grown on considerable land areas. Corn and soy beans were among the first food plants to be gene modified and are the most common gene modified crop. ‘More than half of the food we eat contains products from soy beans, such as bread, mayonnaise, soups, potato chips and chocolate,’’ Sissel Rogne explains.
There is always a potential danger in introducing new technologies, and biotechnology is no exception. The uncertainty regarding what may and may not happen, wanted or unwanted, must be dealt with. It is a challenge for all governments to identify, manage and control the risk aspects connected to biotechnology. There are, however, contradictory views on the uncertainty involved and the potential consequences. From one point of view it is claimed that the high level of uncertainty makes a risk assessment impossible and a precautionary approach is therefore recommended. From another point of view it is asserted that the high level of uncertainty makes risk assessments useful and necessary.
Sissel Rogne does not rule out that risk assessments may prove to be advantageous to governments within the field of biotechnology.‘DNV’s experience within environmental risk assessments is very interesting and we want to look further into this,’ she says.
Applications require a risk assessment
Companies must apply to the national governments to have authorization to introduce gene modified products to a market, and they are obliged to present extensive information and documentation in their applications.
‘‘Third party risk assessments would contribute to make the applications carry more weight and build up trust,’ Sissel Rogne says having no problems admitting that there is a market potential for such services as they will contribute to increase the public confidence in the governmental judgements.
"When treating such applications all health and environmental aspects must be given a thorough assessment,’’ she says finding DNV with its objectivity and reputation combined with its experience in risk assessments highly interesting to cooperate with. That is why the Norwegian Biotechnology Advisory Board chose DNV as partner when they arranged the international conference "Assessing risks from transgenic plants" recently. Here methods to analyse environmental risks associated with gene modified plants were explored. Internationally recognised speakers presented their ideas on how the risks associated with gene modified plants should be assessed and managed.
‘‘The conference resulted in a lively debate reflecting the polarised position that these issues have generated,’’ Sissel Rogne says satisfied both with the conference and the cooperation with DNV.
Gene modified organisms is one of the areas of DNV’s service development being explored in the exciting area of biological risk assessments, or bio-risk.