As a company using biotechnology to manufacture many of its products, Novo Nordisk must ensure a high degree of certainty that the technologies used do not have unintended effects.
Safety of Genetic Engineering
Denmark continues to apply extensive rules to genetic engineering. Registration by the authorities is required from the start of the first trials with a new microorganism. Further approvals are necessary for large-scale experiments with more than 10 litres of culture medium, and legislation requires approval of all pilot plants and laboratories. Viable GMOs may not be discharged from laboratories or large-scale pilot plants.
Microorganisms approved for production are tested for their ability to survive outside the production plants and for possible detrimental effects on people and the environment. Consequently, the authorities permit small quantities of approved microorganisms to be released in waste water, in air emissions and in solid waste. These threshold values are continuously monitored by the company and controlled by the local environmental authority. For example, permission is currently given for emission of up to 10,000 organisms of genetically-modified Aspergillus strain per ml of waste water, 100 organisms per m3 of air, and 10,000 organisms per gramme of solid waste.
In cooperation with the environmental authorities Novo Nordisk has performed retrieval trials in the areas around the factories using GMOs. No examples have been found of such a production strain becoming viable in nature.
1996 Target: Publish results from trials to retrieve two genetically-modified production strains in nature.
Treatment of the biological waste ensures that the microorganisms are inactivated and that the biomass is stabilized at a high pH value. This prevents other microorganisms from growing in the biomass. The biomass' composition of organically bound nutrients gives it a high fertilizer value. As a large proportion of the nutrients are bound in organic material which is degraded relatively slowly the risk of nutrients leaching to the aquatic environment is minimal.
Safety of Products
Table 7a lists Novo Nordisk's products manufactured using genetic engineering.
Genetic Engineering Reduces Consumption of Resources
This technology also reduces the consumption of resources during manufacturing. Table 7b shows an example of reduced resource consumption when a Novo Nordisk enzyme is made using a genetically-modified production organism, instead of a conventional production organism.
Genetic Engineering Improves Supply Reliability
Table 8 presents an overview of the supply situation if all insulin were to be produced from pig glands.
Safety and Openness on Biotechnology are Important
Safe use of genetic engineering is not only a local issue. During the past year Novo Nordisk has therefore spoken in favour of the international biological safety protocol which has been proposed in connection with the adoption of the convention on preserving biological diversity.
Novo Nordisk representatives have also participated in the global panels of experts under the UN's environmental programme at conferences in Madrid and Cairo, where recommended international biological safety rules were on the agenda.