The HSE corner – Supervision by the Gene Technology Act

The Department has received notification that in the time periode October 17th – 20th it will be conducting audits Health Directorate about our business affected by the Gene Technology Act.
According to the law can work with GMOs (living organisms that have their genetic material altered through genetic engineering) done only when:

1) laboratory where the work is done is approved for operation with the relevant GMO.

2) it is submitted application / report on the research activity.

Ad 1. At our institute exist already approvals of laboratories that will cover most of the activities in question. But it is important that users familiarize themselves with the areas that have been approved, and whether approval will also cover you activity.

Ad2. Any use of GMOs to be reported or apply for a permit. If there must be a permit for starting work is dependent on the risk assessment of the activity.

It’s Directorate of Health is empowered to supervise the Gene Technology Act is followed. Information about applications can be found on their website:

https://helsedirektoratet.no/genteknologi

Here you will find the necessary information; law and regulations, application forms and how the application should be sent. Below link to “Genetically modified microorganisms” you can find a list of the risk assessment of microorganisms, which can be useful.

Not all activities in genetic engineering include GMOs. For example, PCR or sequencing of a PCR product does not cause any living organism, and therefore not covered by the law. But if on the other hand clones the PCR product into a plasmid vector and transforming this into a bacterium, has made a GMO.

Academic questions regarding applications / reports and other questions about GMOs may be directed to Audun H. Nerland (audun.nerland@uib.no, phone 55974653).

The department is required to keep track of all activity on includes GMOs. Copies of the applications to the Directorate of Health, and in response to these applications are therefore asked to be sent to the administration at the institute, Irene.Hjelmaas@uib.no with a copy to (audun.nerland@uib.no).

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