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Procedure for working with genetically modified organisms (GMO)

Procedure should ensure that all work with genetically modified organisms are according to laws and legislation Gene technology Act.

The procedure apply for all work with GMO at Department of biosciences, use of GMO plants, GMO animals, genetically modified microorganisms (GMM) og genetically modified microorganisms in combination with animals. The procedure apply for research and teaching activities involving GMO.

Procedure applies to all contained used of genetically modified organisms at the department.

The procedure is an addition to  "Procedure for laboratory safety; management of work with chemicals, biological agents, genetically modified microorganisms and sources of radiation"

Responsibility

Head of Department has overall responsibility for all laboratory work at IBV and to ensure that all activities with GMO are according to the applications and reports to the The Norwegian Directorate of Health. All applications and reports related to contained use of GMO sent to The Norwegian Directorate of Health must be signed by the head of the department. The head of the department must ensure the dissemination of this procedure to relevant staff and students.

Section leader should ensure that all facilities that are used for activities in research and teaching involving GMO are approved by The Norwegian Directorate of Health for the activities undertaken. The contained used of GMO must be within this frame.

Users are responsible to follow procedure and ensure that all use of GMO are according to the legislation. Users are responsible that the research has an relevant risk assessment, that safety measures are described and preparedness action are formulated. All adverse events with GMO should be reported according to procedure for adverse events.

Method

Definitions

  • Genetically modified organisms (GMO): Micro organisms, plants and animals where the genetic composition has been modified using  gene or cell technology.
  • Micro-organisms: Any cellular or non-cellular microbiological unit capable of reproduction or transferring genetic material.
  • Cell Technology: techniques for producing living cells with new combinations of genetic material by fusion of two or more cells.
  • Gene Technology: techniques including isolation of DNA which is then subject to characterisation and /or modification prior to insertion into living cells or virus.
  • GMM: genetically modifiied micro-organisms.

Approval of laboratories /facilities  

Laboratories/facilities with contained used of GMO, must be approved before work commence by The Norwegian Directorate of Health. The responsible (Ansvarshavende) for all GMO activity is the head of the department, hence he/she should sign all applications. 

Applications are sent using standard forms for more information see links to the right.

Applying contained use of GMOs

All research and teaching activities involving contained use of GMOs must have an approval from The Norwegian Directorate of Health for the planned actitivity.

Applications are sent using standard forms. For more information see links to the right.

The responsible (Ansvarshavende) for all GMO activity is the head of the department, hence he/she should sign all applications.

Research and teaching activity using GMO

  • The supervisor/facility responsible should ensure that all new users are known to the procedure for contained use of GMOs at the department.
  • The user should document the local training given using the Self Declaration form.
  • Users should assess if their GMO activity is within the current approvals.
  • Department and section should at anytime have a record of:
    • employees and students working with or in areas with GMO.
    • which facilities that are approved, and for which type of GMO; use of GMO plants, GMO animals, genetically modified microorganisms (GMM) og genetically modified microorganisms in combination with animals.
    • which research/teaching activities that are approved.

Adverse events - handling and alerting accidental scenarios  

  • In case of an severe adverse event it is important to limit damage as much as possible to ensure that no or as little as possible of the GMO will escape into the environment.
  • The preparedness plan is described in the SOP and/or procedures.
  • Other adverse event (event that could case an accident/ dangerous and / or minor accident) with GMO should be reposted. Use UiOs form available in the procedure for adverse events.
  • Deviation should be reported as a adverse event in  "Speak up!"; Report adverse events
  • An adverse event of accidental escape should be immediately reported to the head of department who will contact the Norwegian Directorate of Health (Helsedirektoratet) Varslingstelefon: 24 16 39 00.

Internal controll kontroll – safety inspection – signposting

  • All activity with GMOs must be described in an SOP where risk assessment and the preparedness plan is described. The collection of SOPs is the total preparedness plan and risk assessment of work with GMO at the department.
  • In the annual safety inspection at the department it is expected that the sections can point at the relevant SOPs and preparedness plan for their GMO activity.
  • All laboraotories approved for GMO activity should be signposted according to the legislation; biological hazards and type of GMO in use.

Relevant procedures

Tools

Referanser

For mor information about the laws and regulation see the Norwegian webpage-

Published Feb. 9, 2015 11:03 AM - Last modified Apr. 23, 2021 3:05 PM