Safety of Genetic Engineering
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
1995 was the 20th anniversary of the implementation of genetic engineering techniques for identifying and transferring genes from one organism to another, and thus using living organisms to make useful enzymes and pharmaceuticals.
From the beginning, Novo Nordisk was involved in the development of genetic engineering technology. When its use in production became relevant we were initially opposed to the necessity of a special law on genetic engineering to regulate the area. However, the Act was passed, and as a result Denmark was in 1986 the first country in the world to introduce legislation regulating the use of genetic engineering. In the subsequent debate we have acknowledged that it is beneficial to have legislation which sets precise requirements of the safety of genetic engineering, since this eliminates uncertainty among the general public concerning the potential risks of using 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.
Biomass is a Valuable Fertilizer
Since 1975 biomass from the factory in Kalundborg has been used as fertilizer on fields, thus reducing the discharge of nutrients to the aquatic environment.
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
Novo Nordisk does not use microorganisms in production which can be detrimental to the environment or to human beings. However, safety regulations extend beyond research and production, since special approvals are also required for sale of a product. Here approval by the Danish authorities is not sufficient, since every country in which the product is sold has its own particular regulations which must be complied with. None of Novo Nordisk's products contain viable production organisms.
Table 7a lists Novo Nordisk's products manufactured using genetic engineering.
Genetic Engineering Reduces Consumption of Resources
Today most Novo Nordisk products are produced with the help of GMOs. Many of the newest enzymes which can replace chemicals in other industries, and reduce consumption of water and energy, could not be manufactured without genetic engineering.
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
In the pharmaceuticals area genetic engineering techniques are important in making products such as insulin and growth hormone. Without genetic engineering it would be difficult to provide a sufficient, stable supply of insulin to the global market. This is even more true for human growth hormone.
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
Novo Nordisk is accustomed to working under extensive safety rules for the application of genetic engineering. Although there are no examples of environmental damage due to production based on GMOs, the company still favours tight public control of use of the technology.
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.
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