Accidental releases of GMO materials in Bagsværd
- August 2004
On 17 and 18 August 2004, Novo Nordisk had two accidental releases of materials containing GMOs – genetically modified organisms - at the production site in Bagsværd.
The GMOs in question cannot survive outside of their usual protected environment in the laboratory. It is therefore very unlikely that the GMO cells could spread to the external environment, or that they could possibly harm humans. The two accidental releases were independent of each other.
Nevertheless, the affected areas were disinfected immediately. This was done in compliance with Novo Nordisk Standard Operating Procedures. There have been no previous incidents recorded in the period since 2000, when the company's enzymes and healthcare businesses were demerged. For reference, click here
“To Novo Nordisk, any accidental release is unacceptable. We have allocated all necessary resources to secure that such accidents should not happen again,” says Lise Kingo, Executive Vice President, Corporate Stakeholder Relations. Technical solutions to avoid recurrence have already been implemented and the risk assessments of those facilities in Novo Nordisk A/S that are working with GMOs will be re-evaluated.
The authorities have been informed and are satisfied with the immediate response and the suggested corrective actions. The Danish Occupational Health authorities inspected the facilities on 25 August 2004 and found no reason to call for immediate actions. For details on the accidental releases, see below.
The incident on 17 August occured at Novo Nordisk’s BioProcess Pilot Plant
During a transfer of liquid from a tank to a truck, approximately 500 litres of water containing approximately 3 ml GMO liquid from a laboratory was accidentally let to the rainwater drainage. The GMO liquid concentration in the discharged water was 6x103 cells per ml. The rainwater drainage was afterwards disinfected.
The following corrective actions have been agreed with the authorities:
- A technical solution will be implemented to ensure that the pump will stop pumping once the truck is filled. The tank will not be emptied until this is implemented
- The rainwater drainage will be blocked during the pumping process
- A test of the emergency preparedness plan (use of emergency stop, information to internal and external stakeholders) will be conducted in September 2004
- Standard Operating Procedures will be evaluated and the required changes implemented
The incident on 18 August occured at Novo Nordisk’s Cell Culture Pilot Plant
During the cleaning process, 10 litres of media containing GMO were discharged directly into the sewage system. Normally the media would be discharged into a tank. When the operator saw the accidental release, the discharge of the media was stopped and the sewage system was disinfected.
The following corrective actions have been agreed with the authorities:
- Changes have been made to the Standard Operating Procedure for the cleaning process
- The sewage system has been changed so that all liquid discharged from that area will go to the tank for inactivating, thus eliminating accidental releases due to operating errors
