Work with genetically modified organisms
Genetically modified organisms (GMOs) are microorganisms, plants and animals whose genetic composition has been altered using genetic engineering or cell technology.
Genetic engineering involves methods of isolating, characterizing and modifying genetic material and inserting it into living cells or viruses. Genetic engineering is regulated by the Gene Technology Act.
Norsk versjon: Arbeid med genmodifisert materiale
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Before you work with genetically modified organisms #
Laboratories and other facilities for contained use must be approved in advance by the Norwegian Directorate of Health. The use of genetically modified organisms must also be reported to the Directorate.
More information and various forms for applying for approval and for reporting are available from the Directorate of Health’s website on genetic engineering (in Norwegian).
Work on genetically modified microorganisms that are classified in human pathogen hazard groups 2, 3 or 4 according to the Regulations concerning action and limit values, Annex 2, must also be reported to the Labour Inspection Authority (Regulations concerning the performance of work, Section 6-3 ). When using new GMOs, it is not necessary to send a new notification (except for hazard group 4).
Units at NTNU must have procedures for registering all new projects that involve the use of GMOs, conducting a risk assessment of these projects, and ensuring that approval and notification to the Directorate of Health are in order. Changes to existing projects must be handled in the same way.
Annexes III and IV of the Forskrift om genmodifiserte mikroorganismer (Regulations on genetically modified microorganisms) and Annex III of the Forskrift om genmodifiserte planter (Regulations on genetically modified plants) contain helpful information for assessing the risk of work with these organisms. Other sources of general information on genetically modified organisms are listed under help.
Formulate notifications to the Directorate of Health in a way that will cover any minor changes in the projects. For example, it is not necessary to send a new notification every time you replace a bacterium in an existing research set-up (if the bacteria in question are classified in the same hazard group). However, activity or agents classified at containment level 3 must always be reported separately.
Containment measures #
Containment is necessary for any work operation in which genetically modified organisms are produced, cultured, stored, destroyed or used in other ways. This means that work on GMOs must take place in a closed system using physical and possibly other specific containment measures. The aim is to ensure a high level of safety for humans and the environment by limiting contact with GMOs.
Genetically modified animals #
The classification of the genetically modified animal determines the containment requirements for the laboratories and facilities to be used. Animals covered by the regulation are classified as vertebrates, invertebrates or aquatic animals. For activities where genetically modified animals fall into several of these classifications, containment measures for the individual groups must be combined.
Laboratories for using genetically modified animals must meet the technical requirements stated in the application form for approval of laboratories and facilities (Annex I, Regulation on contained use of genetically modified animals, in Norwegian). Laboratories must be designed in accordance with requirements for containment measures (biosafety level, BSL), Section 8-4 of the Workplace Regulations.
Genetically modified plants #
Genetically modified plants are classified at a containment level based on the plants’ potential for outdoor establishment and dissemination as well as their ability to release pollen, on the scale S2-S4.
- S2 = contained use of genetically modified plants with high biological containment, i.e. plants without the capacity for outdoor establishment and dissemination
- S3 = contained use of genetically modified plants with moderate biological containment, that is, plants with the potential for outdoor establishment and dissemination, but with little capacity for the release of pollen
- S4 = contained use of genetically modified plants with low biological containment, i.e. plants with the capacity for outdoor establishment and dissemination as well as the ability to release pollen.
The requirements for containment measures are specified in the application form in Annex I in the Regulations on contained use of genetically modified plants (in Norwegian).
Genetically modified microorganisms #
Microorganisms are defined as any cellular or non-cellular microbiological entity capable of replication or transferring genetic material, including viruses, viroids, animal cells and plant cells in culture.
Several types of genetically modified microorganisms are classified according to the risk of infection they pose to humans (see the Regulations concerning action and limit values, Annex 2), and the hazard groups have associated containment levels designed to prevent the microorganism from coming into unintended contact with humans or the environment.
Laboratories and facilities for work with genetically modified microorganisms are classified in containment levels 1, 2, 3 and 4, where 1 is the lowest containment level. The minimum requirements for containment measures are shown in the table in Annex I C, I D, and I F in the Regulations on contained use of genetically modified microorganisms (in Norwegian). In some cases, it may be necessary to use a combination of measures from the tables.
Necessary containment measures in connection with the use of genetically modified organisms are described in more detail in various regulations. Here, special containment requirements are also described for the combined use of genetically modified microorganisms, animals and/or plants.
If there is any doubt about which containment levels and containment measures are appropriate for planned contained use, the most stringent protective measures must be used.
Procedure for incidents involving GMO #
Units at NTNU must have procedures for handling non-conformances or incidents that occur during work with genetically modified organisms. As a minimum, the routines must include information about resource persons internally at the department or at the faculty who can help if an incident occurs.
Spills that contain genetically modified microorganisms should be handled in the same way as infectious biological factors, for example as follows:
Use disposable gloves. Wipe up as much of the spill as possible with paper towels. Clean the surface using sodium hypochlorite solution. For larger spills: Cover the surface in paper towels and soak them with diluted sodium hypochlorite (1:3) or concentrated sodium hypochlorite. Let this stand for ½ - 1 hour.
If this is not possible, clean the surface thoroughly with sodium hypochlorite solution (without leaving it to soak) or with a 70 % alcohol disinfectant.
Put the paper and other materials used for cleaning, other paper and gloves that have been in contact with the spill in a plastic bag. Tie up the bag and dispose of it in the same way as for other biological materials. Finally, use an ordinary detergent for cleaning.
Use common sense and knowledge about infection pathways and modes of transmission. Always keep in mind those who will take over the work after you; cleaning staff at the workplace and personnel at incineration plants.
Reporting non-conformances and incidents #
All non-conformances/incidents involving genetically modified organisms must be reported to the person with responsibility for the subject area internally at the unit, to NTNU’s system for reporting non-conformances and incidents and in an email to the Directorate of Health, Avdeling for bioteknologi og helserett (Department of Biotechnology and Health Legislation), firstname.lastname@example.org.
After exposure to biological factors (microorganisms) in hazard groups 3 and 4, as well as some factors in hazard group 2, employees/students must be registered in the exposure index.
- Biosafety in Microbiological and Biomedical Laboratories (BMBL) – Centers for Disease Control and Prevention (USA)
- Department of Biotechnology and Health Legislation, Norwegian Directorate of Health
- The Gene Technology Act (genteknologiloven)
- Forskrift om innesluttet bruk av genmodifiserte mikroorganismer (Regulations for the contained use of genetically modified microorganisms)
- Forskrift om innesluttet bruk av genmodifiserte dyr (dyreforskriften) (Regulations on the contained use of genetically modified animals)
- Forskrift om innesluttet bruk av genmodifiserte planter (planteforskriften) (Regulations for the contained use of genetically modified plants)
- Forskrift om merking, transport, import og eksport av genmodifiserte mikroorganismer (Regulations on the labelling, transport, import and export of genetically modified microorganisms)
- Forskrift om bestemte former for undervisningsvirksomhet som innebærer innesluttet bruk av genmodifiserte mikroorganismer (Regulations on certain types of teaching activities involving the use of genetically modified microorganisms)
- Regulations concerning the design and layout of workplaces and work premises (the Workplace Regulations)
- The occupational health service
- The HSE section
- Margunn Losnegard Karlsen, occupational nurse
- Ann Kristin Sjaastad, occupational hygienist
- Bjørg Aadahl, occupational health doctor
Approved by the HSE Director – 6 March 2018
Last edited 08.04.2019