Guidelines for genetically modified organisms (GMOs)

Norwegian version

Approved by the University Director 10 December 2020, archive reference 2014/8109.

1. Purpose

The guidelines shall help ensure that all use and handling of GMOs at the University of Bergen are performed safely and securely and in line with the Norwegian Act relating to the production and use of genetically modified organisms and its regulations.

2. The validity of the guidelines

2.1 Activities covered by the Act (list not exhaustive)

• Plasmid transformed bacteria for DNA preparation.

• DNA transfer from bacteria to e.g., plant cells.

• Transfer of genetic material to animals; the animals are classified as GMOs.

• Organisms, cells or tissues where DNA is edited using new mutagenesis technology, such as CRISPR/Cas9.

• RNA transfection of cell cultures and living organisms, even when transient.

• Humans are not covered by the Gene Technology Act and can legally not be genetically modified. Human cells in culture that have not been genetically modified or been recipients of DNA or RNA, however, are classified as genetically modified microorganisms (GMM) and are governed by the Act.

2.2 Activities not covered by the Act:

Isolation of DNA or RNA and analysing these using techniques such as PCR, restriction enzymes etc., as long as the genome material is not inserted into cells, tissues or organisms that can reproduce.

3. Definitions

• Genetically modified microorganisms (GMOs): microorganisms whose genetic composition has been altered using gene or cell technology.

• Genetically modified microorganisms (GMM): Microorganisms where the genetic composition has been altered using gene or cell technology.

• Gene technology: techniques that entail isolation, characterisation, modification and insertion of genetic material into living cells or virus

• Microorganisms: Any cellular or non-cellular microbiological entity that is capable of reproducing itself or transferring genetic material. (NB! Animal or plant cells cultivated in culture are defined as microorganisms in this context).

4. Categories of use; contained use and deliberate release:

4.1 Contained use:

Any work operation in which genetically modified organisms are produced, grown, stored, destroyed, or otherwise used, in a closed system using physical containment measures, possibly in combination with other special containment measures, to limit the organisms’ contact with humans and the environment so that these are ensured a high level of security.

All persons who work with contained use of GMOs shall keep a journal in accordance with the Internal control regulations.

4.2 Deliberate release

The term «deliberate release» means any production and use of genetically modified organisms that is not considered to be contained use.

All use and production of GMOs that are not considered to be contained require approval before deliberate release. Applications for deliberate release of GMOs are processed by the Ministry of Climate and Environment, via the Norwegian Environment Agency.

The following are among the activities that are considered to be deliberate release under the Act:

• deliberate release of genetically modified organisms for research purposes (field experiments)

• deliberate release of genetically modified organisms for commercial purposes, for remedial purposes and the like

• use of genetically modified organisms in greenhouses, aquaculture facilities, animal accommodation and the like, unless the facility in question is approved for contained use as part of an approved laboratory or other installation

• routine release of genetically modified organisms from contained use

• disposal of waste containing living genetically modified organisms

• placing on the market of a product consisting of or containing genetically modified organisms

• Labelling, transport, import and export of GMOs.

5 Risk classification (NO):

Class 1:	Activities involving no risk, or only negligible risk for human and animal health and the environment.
Class 2:	Activities involving low risk for human and animal health and the environment.
Class 3:	Activities involving moderate risk for human and animal health and the environment.
Class 4:	Activities involving high risk for human and animal health and the environment..

6. Report/application

Committee for biosecurity

An advisory committee at the University of Bergen for the introduction and use of biological risk factors including GMOs. A report/application to the authorities is required for all use of GMOs.

6.1 For contained use, an application must first be submitted for approval of laboratories where the GMOs are to be used. Such an application is sent to the Norwegian Directorate of Health (NO).

6.2 If the laboratory is approved for such use, a report/application must be submitted for the project in which the activity will be involved. Such an application is also sent to the Norwegian Directorate of Health (NO).

For activities in class 1 and class 2, it is sufficient to send a report.

For activities in class 3 and class 4, an application must be submitted and approved before the activity can start. The application must also describe safety measures to prevent unintentional discharge and an impact assessment in the event of a discharge.

6.3 For deliberate release, an application must be sent to the Norwegian Environment Agency..

For deliberate release, an impact assessment relating to the environment is required.

In addition: Although not defined as GMO, the Gene Technology Act prohibits cloning of vertebrates and crustaceans. Applications may be submitted, however, for exemptions for medical purposes.

7. Summary of key factors when working with GMOs

1. An application for approval must be submitted to the Norwegian Directorate of Health (NO) unless the laboratories are approved for the purpose in relation to risk class.

2. A report/application must be sent to the Norwegian Directorate of Health regarding the activity, and the activity must correspond to the level for which the laboratory is approved.

3. Personnel working with GMOs shall be provided with appropriate training. They shall also be informed of what the work involves, the risks involved with the work and correct waste management.

4. Satisfactory laboratory journals shall be kept of all work performed.

5. The work must be performed in accordance with “Good Laboratory Practice” in order to ensure compliance with the relevant containment levels, for example in relation to waste management.

6. Transport of GMOs outside the containment levels must comply with the regulations.

8. References

• The Working Environment Act

• Regulations relating to the labelling, transport, import and export of genetically modified organisms

• Regulation concerning organisation, management and employee participation

• Regulations concerning the performance of work, use of work equipment and related technical requirements

• Regulations concerning the design and layout of workplaces and work premises

• List of classified biological factors (infection risk groups, regulation on measures and thresholds)

• Regulations concerning the contained use of genetically modified microorganisms (NO)

• The Norwegian Gene Technology Act

• Form Norwegian Directorate of Health – approval and report (NO)

• Waste routines – HSE gateway

Date	Comment	Entered by
May	New Guideline	Mona Viksøy