SOP101 Procedure for Work with Genetically Modified Microbes and Organisms (GMM/GMO)

Standard Operating Procedure (SOP)

Title: Procedure for Work with Genetically Modified Microbes and Organisms (GMM/GMO)

Document ID: SOP101
Section: Section for Research
Department: Department of Microbiology
Division: Division of Laboratory Medicine (KLM), Oslo University Hospital (OUH)
Written by: Mari Kaarbø
Approved by: Hilde Nilsen
Date: 10.09.2025

 

1. Purpose and Scope

This SOP describes requirements and procedures for safe handling of genetically modified microbes (GMMs) and organisms (GMOs) within the Section for Research, Department of Microbiology, OUH.

A GMM is a genetically modified microbe. A GMO is a genetically modified organism or cell line whose genetic material has been altered using gene or cell technology.

Several laboratories at Section for Research at MIK are approved for contained use of GMMs/GMOs (GMM/GMO Risk Group 1 and 2) at laboratory scale.

2. Responsibilities

  • Division Director, KLM – Holds overall responsibility for laboratories, including biological safety.
  • Department Head, MIK – Responsible for local implementation ,
  • GMO responsible, Section of Research – Responsible for training, and compliance with this SOP.
  • Laboratory Staff and Guest Researchers – Must follow all safety routines and report deviations or incidents.

3. Procedure

3.1 Laboratory Requirements

  • Work with GMMs/GMOs in Risk Group 2 must only occur in approved Class 2 laboratories.
  • The Section maintains an updated list of approved laboratories and permitted activities.
  • Minimum requirements:
    • Laboratories must be separated from unrelated activities.
    • Work surfaces must be waterproof, easy to clean, and resistant to disinfectants.

3.2 Signage

  • Entrances to GMO laboratories must display the biohazard symbol.

3.3 Storage of Samples

  • All GMM/GMO samples must be securely stored in dedicated refrigerators/freezers.

3.4 General Work Routines

(Applies to all employees and guest researchers)

  • Wash hands before and after laboratory work.
  • Wear protective clothing (lab coat/gown).
  • Gloves must be used:
    • Latex/vinyl gloves for handling biological materials.
  • Eating, drinking, and storage of food are prohibited in laboratories.
  • Personal belongings (bags, phones, coats) are not permitted inside GMO laboratories.
  • Gloves and lab coats must not be worn in offices, break rooms, or lunch areas.
  • Aerosol-generating procedures must be performed in designated areas.
  • Laboratories must be kept clean, tidy, and free of clutter.

3.5 Disinfection Routines

  • Virkon 1% – For surfaces/equipment; effective against viruses, bacteria, and fungi (not M. tuberculosis or C. difficile).
  • 70% ethanol – For surfaces/objects; effective against vegetative bacteria and mycobacteria.
  • NaOH (0.4–4% / 0.1–1N) – For inactivation of non-microbial GMOs (e.g., GMO cell lines, transfected cells; acts by crosslinking nucleic acids).

3.6 Waste Management

  • Sharps/pipette tips – Collect in yellow plastic/cardboard containers; dispose of as risk waste.
  • Solid waste – Collect as risk waste and inactivate before disposal.
  • Liquid waste – Collect in sealed plastic bottles, transfer to yellow risk-waste containers.
  • All risk waste is incinerated at Klemetsrud Facility, Oslo.

3.7 Training

  • Training is department-specific and the responsibility of the GMO-responsible.
  • Only trained and authorized personnel may work with GMMs/GMOs.

3.8 Incident Handling

  • In case of spills or accidents:
    • Wear gloves and protective clothing.
    • Use Virkon or 70% ethanol depending on the material.
  • Surface spill: Cover with absorbent material soaked in disinfectant; allow 30 min contact.
  • Broken centrifuge tube:
    1. Hold breath and close centrifuge lid.
    2. Leave the room, close the door, and inform others.
    3. Wait 30 minutes for aerosols to settle; post warning on the door.
    4. Re-enter wearing full personal protective equipment (PPE, including mask); disinfect, remove glass/samples, allow 30 min contact.
    5. Wash surfaces with water and resume work.

3.9 Reporting

  • Situations involving infection risk must be reported to the GMO responsible.
  • Report accidents, near-misses, or hazards in Achilles (HMS deviation system).
  • Notify Helsedirektoratet if required.
  • Incidents involving cells/tissues must be reported via melde.no.

3.10 Risk Assessment & Contingency Planning

  • GMO Class 2 organisms may cause infections but are unlikely to spread to the community or environment.
  • Environmental risks (survival, reproduction, interaction with other organisms) are minimal.
  • In case of accidental release, notify the Norwegian Environment Agency (Miljødirektoratet), including:
    • Circumstances of the incident.
    • Identity and quantity of GMO released.
    • Potential health and environmental risks.
    • Measures taken.

4. Definitions

  • GMM (Genetically Modified Microbe): Microbial unit (cellular or non-cellular) capable of reproduction or gene transfer, altered using gene or cell technology.
  • GMO (Genetically Modified Organism): Organism, plant, animal, or cell line with genetic material altered using gene or cell technology.
  • Gene Technology: Methods for isolating, modifying, and inserting genetic material.
  • Cell Technology: Fusion of two or more cells to create new genetic combinations.
  • Cloned Animal: Animal with identical or nearly identical genetic material to another.

5. References

  • Miljødirektoratet
  • Helsedirektoratet
  • melde.no
  • Bioteknologirådet
  • OUS Emergency Preparedness Plans (General & GMO-specific)
  • Genteknologiloven – Quality and safety requirements for GMOs

 

 
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