SOP102 Contingency Plan for Accidental Release of Genetically Modified Microbes and Organisms (GMMs/GMOs)

Standard Operating Procedure (SOP)

Title: Contingency Plan for Accidental Release of Genetically Modified Microbes and Organisms (GMMs/GMOs)

Document ID: SOP102
Section: Section for Research
Department: Department of Microbiology
Division: Division of Laboratory Medicine (KLM), Oslo University Hospital (OUH)
Written by: Mari Kaarbø
Date: 01.06.2019
Approved by: Hilde Nilsen
Date: 15.02.2022
Updated: 10.09.2025

1. Purpose and Scope

This SOP establishes procedures to ensure safe and correct handling in the event of an accidental release of genetically modified microbes (GMMs) or organisms (GMOs) within the Section for Research, Department of Microbiology, OUH.

2. Responsibilities

  • All employees and researchers working with GMMs/GMOs in the section laboratories are responsible for following this SOP.
  • GMO responsible must ensure that all staff are trained and familiar with contingency procedures.

3. Procedure – Contingency Plan for Accidental Release of GMMs/GMOs, see #SOP101

3.1 Special Precautions

  • Laboratory access is restricted; doors remain locked outside core working hours.
  • Waste in contact with GMMs/GMOs must be collected in designated containers for sterilization or destruction.
  • Equipment in direct contact with GMMs/GMOs must be either single-use or autoclaved after use.
  • All GMO/GMM work must be performed by, or under the supervision of departmental personnel.

3.2 Actions in Case of Suspected Release

  • Local release: Immediately sterilize the affected area with appropriate disinfectant solution.
  • Contaminated personnel: Remove or decontaminate affected clothing; seek medical evaluation if necessary.
  • Reporting obligations:
    • Record all releases and deviations in Achilles (HMS deviation system).
    • If released into a sink/drain, notify the Norwegian Directorate of Health (Helsedirektoratet).
    • Report unintended events to Helsedirektoratet via “Meld uønsket hendelse”.

3.3 Structural Safety Measures

  • GMO/GMM work at Biosafety Level 2 must be conducted in aerosol-protected biosafety cabinets (LAF benches).
  • Laboratory access is restricted outside of normal working hours.

4. Definitions

  • GMM – Genetically Modified Microbe: A microbial unit with altered genetic material.
  • GMO – Genetically Modified Organism: Any organism whose genetic material has been altered using gene or cell technology.

5. References

  • Safety Measures §13:
    • Procedure – Contingency Plan for Accidental Release of GMMs/GMOs
  • Regulation on Contained Use of Genetically Modified Animals (Dyreforskriften):
    👉 Forskrift om innesluttet bruk av genmodifiserte dyr
  • Related eHandbook Documents:
    • Genetically Modified Organisms – Quality and Safety Requirements under the Gene Technology Act

 

 
Oct 3, 2025
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