Working with genetically modified organisms

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Internal Guidelines for working with genetically modified organisms (GMOs) at The Department of Biomedicine, University of Bergen.

The guidelines must meet these rules and provide procedures to prevent the spread of genetically modified microorganisms (GMM) and genetically modified animals, and prevent the workforce from exposure to potential health problems. They should contribute to a good working environment by promoting predictability and safety in the workplace.

See Regulations on contained use of genetically modified microorganisms, and Regulations on contained use of genetically modified animals (Norwegian only).

Definitions and laws

Biotechnology All use of living organisms (plant cells, animal cells and microorganisms) to make products that are useful and necessary for us.
Genetic engineering Technology based on the fact that one can isolate, study and change the genetic material, DNA.
Modern biotechnology Common name for various new biotechnological methods, where genetic engineering is a more or less important component. Examples of applications of modern biotechnology are genetic modification of living organisms, gene therapy on humans, genetic testing, stem cell research, artificial insemination, cloning and xenotransplantation.

It is possible to misuse modern biotechnology, it is therefore regulated by law in Norway. There are two main laws, the first covers the medical use of biotechnology on humans (Biotechnology Act); the second covers microorganisms, plants and animals, where the genetic composition has been altered using gene and cell technology (Gene Technology Act).

Contained use

  • All use of GMO shall be done in a closed system where physical containment measures are employed to limit the organisms contact with people and the environment.
  • All the contained use of GMOs should be carried out in facilities approved by the Directorate of Health.
  • All the contained use of GMOs requires authorization or notification to the Directory of Health.
  • Any use of GMOs that are not contained is regarded as launching and must be approved by the Ministry of the Environment.
  • Anyone who works with the contained use of GMOs shall perform internal control in accordance with internal regulations.
  • Containment is to be taken seriously: GMO must NOT be spread into the environment!

Additional information

Gene Technology Act

Management of the Genetic Engineering Act is divided between the Ministry of Health (contained use) and Ministry of the Environment (launching in nature). The Ministry of Health and Care Services has delegated authority to manage its share of the Gene Technology Act and biotechnology law to The Norwegian Directorate of Health. In cases where special ethical questions are raised then opinion must be sought from The Norwegian Biotechnology Advisory Board (Bioteknologinemda) that has an advisory role to the Directory.

Gene Technology Act regulations:

  • Contained use of genetically modified microorganisms
  • Contained use of genetically modified plants
  • Contained use of genetically modified animals
  • Transport of genetically modified organisms
  • Genetically modified organisms in teaching

The Gene Technology Act concerns:

  • Preparation and use of genetically modified organisms
  • Materials and products consisting of, or containing, genetically modified organisms, including human cells in culture, plasmid-transformed bacteria for preparation of DNA and DNA transfer from bacteria to e.g. plant cells.
  • The production of cloned vertebrates and crustaceans.

The Gene Technology Act does not cover:

  • Natural processes (reproduction, recombination)
  • Traditional breeding methods
  • Mutagens or radiation (excluding site-directed mutagenesis)
  • Traditional cell technology methods
  • Cell fusion within the same species
  • In vitro fertilization (artificial insemination)
  • All DNA uptake assuming this to be non-recombinant DNA
  • Polyploidy w/chemical treatment
  • Naked DNA

Legal requirements

Approval is required for:

  • Use of genetically modified micro-organisms in containment level 3 and 4 (i.e involves a moderate to high risk of illness / injury to people, animals, plants or the environment)
  • All the contained use of genetically modified plants
  • All the contained use of genetically modified animals, unless permission has been granted under the auspices of the Animal Welfare Act.
  • Transmission of human genetic material unless the purpose is to identify and characterize genes

No notification or approval is required for:

  • Production of antibodies
  • Isolation of chromosomes and chromosome fragments

For the Norwegian definitions see Law regarding preparation and use of genetically modified microorganisms and Law regarding preparation and use of genetically modified animals (Animal Act).


The primary responsibility follows the organizational lines.

The Group leaders is responsible for training at their laboratory.

Training shall be documented by setting up a list of those who have received training, and what they have been trained in. here must be a concise set of working instructions available.

Responsibility for record keeping : Each researcher/technician. It requires the regular upkeep of a journal of research work performed. The record must be presented for inspection upon request.

Responsibility for risk and vulnerability assessment (ROS): Before a new working method is used it is the group leaders responsibility that a vulnerability analysis is made available in writing. This analysis shall be submitted to the research consultant of the department. Please refer to the instructions at the end of this chapter.

Notifications and applications

The Group leader is responsible that applications are prepared and are registered as required by the regulations and submitted to the research consultant of the department who shall forward registered applications to the Health Directorate.

More information can be found on the web page of The Health Directorate. Unfortunately most of their content is only available in Norwegian.

Additional information

Law regarding preparation and use of genetically modified organisms

Law regarding preparation and use of genetically modified animals (Animal Act)

Law regarding preparation and use of genetically modified organisms and more (Gene Technology Act)

In the Law regarding preparation and use of genetically modified organisms and the Law regarding preparation and use of genetically modified animals (Animal Act) you can find application forms for using GMMs and GMOs. The forms are in PDF-format, but can be copied into Word and filled out electronically.

In addition the web pages of The Health Directorate has contact information if you have additional questions or inquiries.

Description of the area and what can be done where

For essential information on work with genetically modified organisms refer to The Norwegian Directorate of Health.

All laboratories on the 5th and 6th floors marked with yellow "Biohazard" signs are approved for work with genetically modified micro-organisms that require containment level 2.

The animal facility on 7th floor and the "gray zone" (eastern part of the floor) is approved for work with genetically modified vertebrates that require containment level 2. The animal stalling rooms and rooms assigned for experimental procedures in the ”black zone” are also approved for the combined use of genetically modified animals and genetically modified microorganisms provided that the rooms are labeled for this activity and that the particular routines for such work are followed. In the ”white zone” on the 7th floor the rooms that are marked with yellow "Biohazard" signs are approved for work with genetically modified microorganisms.

In the BSL-3 area on the 6th floor the inner niche is approved for GMM work requiring containment level 2, while the two laboratories within the area are approved for GMM work requiring containment level 3.

The BSL-3 Division, Animal Facility, and the "gray zone" on the 7th floor have separate controlled entrances and are only available to persons who are authorized users of each of these areas. Work performed in these areas should follow the procedures that are specific to each area.


The cloning of vertebrates and crustaceans is forbidden.

The Ministry, or a person appointed by the Ministry, may grant (following application) an exemption from the prohibition of cloning in biological and medical research or for medical purposes. A condition to obtain exemption for cloning in medical activities is that the aim is to generate new treatments and preventive measures for people and animals, and that there is a balance between the ethics of working with animals and expected outcome.

The granting of exemption does not include cloning of primates.

Application for exemption shall include a balance between utility and the stress to which the animal is exposed, including the animal's integrity, instincts and well-being. A person seeking to produce cloned animals must take into consideration the alternative methods that exist and take these into account when submitting the application.

A protocol shall be kept of all operational activities performed. The Authorities may require disclosure of information about cloning carried out under the conditions granted for use in the public records related to cloning operations.

The sites used for cloning should be suitable for the purpose and be equipped and furnished appropriately for the functions to be performed.

The following regulations apply to all areas that are approved for GMO work

  • Access only for authorized persons.
  • The doors to the area must always be closed.
  • Eating or drinking in the area is not permitted.
  • The storage of food for human consumption is not allowed.
  • A laboratory coat or other appropriate protective clothing and suitable gloves shall be used where required.

Additional information

Law regarding preparation and use of genetically modified organisms (Gene Technology Act)(Norwegian only) and the law regarding preparation and use of genetically modified animals (Animal Act)(Norwegian only).


Work Routines

The Group leader is responsible for assuring that the written work procedures adapted for a particular task are available.

The procedures shall ensure that work is carried out without endangering the health and safety of the employee, and without harming the environment.

Each employee is responsible for ensuring that work practices are followed. The procedures must be available for inspection upon request.

Procedures for handling waste

For general waste handeling procedures see Waste Management and The HSE-portal for UoB.

Waste of genetically modified microorganisms

Dry infected waste packed in plastic bags and placed in cartons, labeled according to UiB's regulations, and sent for combustion. Liquid waste is autoclaved and then treated as other liquid wastes see Waste Management.

For waste when working with retroviruses see Guidelines for working with retroviruses.

For avfallsrutiner i forbindelse med arbeid i BSL-3-laboratoriet henvises til chapter regarding the safetylaboratory.

Waste when working with genetically modified animals

Euthanized animals must be packed in double plastic bags and delivered for combustion according to the general rules of the department. Cage content must be packed in double plastic bags and delivered for combustion. Equipment must be wrapped in plastic bags and delivered either for incineration or autoclaving. Liquids that are infected with genetically modified organisms should be autoclaved and then treated as liquid waste.

The workplace should be disinfected.

Deviation from regulations


Spills of material containing genetically modified organisms shall immediately be dried-up with absorbent paper, later sent for combustion. The area must be disinfected with 70% ethanol, or by using vikron/chloramine (see "disinfect" below). During the work use gloves and any other appropriate protection.

If the area cannot be disinfected immediately, you must

  • Mark the area that may be contaminated
  • Optionally block the area to avoid infection/contamination of other persons
  • If needed call for help
  • Start disinfection (70% ethanol or disinfection fluid)
  • Identify and record the biological factor
  • Notify the group leader and the executive manager of the department

The Group leader is responsible for making any additional rules with regard to the handling of spills and accidents and that these are included in the Group's internal control documentation.

Stick or cut injury

Rinse for 5 minutes in running water. Use eyewash solution or an eye shower after splashing in the eye. If spillage of infectious material has occurred on skin then a skin disinfectant can be used for 3-4 minutes. If the stick or cut is likely to cause a risk of infection, then you should take immediate contact with a duty doctor of infective medicine at Haukeland University Hospital on telephone 05300. When there is a risk of infection you can also contact Bergen Emergency Medical Services (Legevakt) telephone 55 56 87 00 or the occupational health centre at the University of Bergen, telephone 55 58 20 54.


Any employee or student who comes across a possible crisis situation shall immediately notify:

Emergency numbers:

Fire 110
Police 112
Ambulance 113

Emergency situations in the BB-building must be reported to the security department at Haukeland University Hospital , telephone (0) 55972004.

Reporting of accidents, near misses and deviations

All accidents and near misses must be reported. This is done by filling out a form for the notification of non-conformities, accidents and near misses. PProcedure for reporting accidents and near misses are described at the HSE-gateway.

If an injury has required medical treatment one should also fill out accident report form to National Insurance Administration (NAV).

If in doubt about what to report or how to file a report, contact Tordis Sundnes (company nurse, at the Occupational Health Centre.

Deviation from the rules is a violation of applicable statutory and internal regulations, goals and plans. Findings shall be recorded and managed appropriately. A copy of the report has to be sent to the Occupational Health Centre. See guidelines in the Safety Manual for notification of deviations.


For disinfection, we have the following methods:

Chemical disinfection

  • 70% ethanol (disinfection of skin and equipment)
  • Skin disinfectant (eg. "Chlorhexidine ", "pyricept") (disinfection of skin and wounds)
  • Hypochlorite (e.g. "Bleach") (disinfection of equipment)
  • Detergent (e.g. "Vircon", "desidos") (disinfection of equipment)


Vapour pressure (121°C, 20 min.) Destroys all microorganisms.


Baking in oven (190°C, 6 hours), destroys all microorganisms.


UV light is used for disinfection of for example workbenches as well as the destruction of DNA/RNA. UV light should not be on while working.

  • 10 min irradiation with UV light on a surface is normally enough to kill all microorganisms on the surface
  • Reduce the use of UV light to a minimum
  • If the UV light has been left on overnight, it should be switched off approx. a half hour before the room is used (to ventilate out the ozone)
  • UV light reacts with the air to form ozone, and it breaks down plastic and wax polish such that small amounts of fairly hazardous gases are formed

Risk evaluation

Application for approval or notification shall include a risk assessment.

It is important to evaluate whether or not the genetic modification can affect the host organism's ability to harm health or the environment. The seriousness of any potential damage shall be assessed independently of the probability that such damage may actually occur.

Any use of genetically modified organisms shall be subject to prior assessment of the risk that the work poses to human health and safety and the environment.

Risk assessment

Step 1:

A. Identification of harmful properties (hazard) of the GMO.

B. Aspects to be considered to the extent they are relevant:

  • The recipient organism
  • The donor organism
  • Gene insert where appropriate (inserts)
  • The vector
  • The final GMO

C. Preliminary classification of the GMO

D. Assessment of the likelihood of the occurrence of adverse effects

Step 2:

A. Determination of final classification and containment measures

B. Confirmation that the final containment measures are adequate

See Appendix 4 in Law regarding preparation and use of genetically modified microorganisms (Norwegian only).

Additional information

For more information please see: