The techniques encompassed by gene technology make it possible to tailor organisms to be safer, more specific and more productive than unmodified counterparts. They can be given the ability to produce valuable substances that would otherwise be in short supply or even be impossible to produce. Extensive legislation regulates the contained use of GMOs (genetically modified (micro)organisms) and only after thorough evaluation of the possible risks associated with every single GMO will the authorities grant a production permit.

Minimizing potential risks
Novo Nordisk started using GMOs in its production in 1986. From the very beginning we have been subject to extensive regulation. Although there are no examples of environmental damage due to fermentation production based on GMOs, we still favour tight public control for the contained use of this technology. Regarding the deliberate release of GMOs, we support the need for an international biosafety protocol.

A thorough evaluation of the possible risks associated with contained use of every new GMO strain is required before the environmental authorities issue an approval for use on an industrial scale. The basis of assessment is made by conducting laboratory tests along with a study of the literature available. This work is carried out by Novo Nordisk, governmental bodies and independent research organizations. To date over 70 risk assessments have been conducted on our GMOs.

"Even though we have constructed our production strains to resist transfer of DNA to other microorganisms, we recognise the public concern for the potential spread of recombinant genetic material to the ecosystem. We are, therefore, reviewing our options for marker genes in new production strains."
Søren Carlsen, Corporate Vice President, Enzyme Research

Public concerns about GMOs in the environment

• Are they safe?
• Can they be pathogenic or toxic to humans?
• Do they have any advantages over equivalent natural organisms?
• Can they survive in nature and disturb the ecological balance?
• Can they transfer genetic material to other organisms?

Documenting the safety of GMOs

Prior to approval by the authorities we have to document that:

• They are non-pathogenic and non-toxic to humans
• They are not able to grow at a faster rate than their wild-type counterparts
• They are not able to establish themselves in the environment
• The recombinant DNA does not provide the GMO with any competitive advantage over natural organisms

Ecological impact - GMOs unable to survive in the environment
Because our GMOs are safe - presenting no risk to human health or to the environment - the environmental authorities have accepted the release of a small number of GMOs. The overview shows where the limited and controlled release of GMOs occurs during the production process, limit values and details of the results of our monitoring programme.

A field study aimed at retrieving two genetically modified production organisms has previously been carried out at the Kalundborg plant in Denmark, our largest production plant. No viable microorganisms were found in samples taken from 22 locations surrounding the plant. This strongly suggests that regular use of our production organisms does not lead to GMOs establishing themselves in the environment outside our production plants. Corresponding studies will also be conducted at some of our other plants. In addition, further studies are being planned to evaluate the transfer of DNA in the environment.

The results of the field study at Kalundborg, Denmark, have been published.

Baker's yeast, Saccharomyces cerevisiae, has been genetically modified for the production of human insulin. Gene technology makes it possible to tailor microorganisms to be safe, specific and productive.

Labelling of GMO products
We acknowledge the consumer's right to know whether a product has been made using gene technology and the right to make a choice based on that knowledge. Novo Nordisk is promoting transparency in the supply chain and we are actively informing our customers and other interested parties about our products and the way they have been produced.

Internet references

Visit our Virtual Lab for a "hands-on" experience of genetic engineering techniques.

See also:

Position paper on the use of genetically modified organisms for production of food enzymes

Position paper on labelling of enzymes manufactured using genetic engineering

Benefits of gene technology

• Improves the efficiency of the industrial production of enzymes and pharmaceuticals
• Reduces the environmental impact of production - less resources are needed per unit produced
• Increases the range of enzyme products tailored to the needs of our customers
• Eliminates the risk of toxic or unwanted by-products produced by microbial donor organisms and avoids the risk of using pathogenic production organisms
• Avoids the problem of finding healthy human and animal donors (of e.g. blood, pancreas and pituitary glands) thereby eliminating the risk of transferring contagious agents
• Ensures sufficient supplies of biopharmaceuticals because we are no longer dependent on animal and human glands

Health Care products made by genetic engineering

Enzyme products made by genetic engineering

Overview of where limited release of GMOs occur during the production process, limit values and details of the results of our monitoring programme at the Kalundborg site

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