Definitions:
Genetically Modified Microorganisms (GMMs): Microorganisms whose genetic composition have been altered by the use of genetic or cellular technology.
Microorganisms: Any cellular or non-cellular microbiological entity capable of reproducing or transmitting genetic material.
Cell technology: Techniques for producing living cells with new combinations of genetic material by fusing two or more cells.
Genetic technology: Techniques that involve the isolation, characterization, modification and insertion of genetic material into living cells or viruses.
Responsibilities:
The head of department has the overall responsibility. The supervisor / room manager is responsible for applying for approval of areas to be used for research / teaching with the included use of GMM. The application is to be sent to the Norwegian Directorate of Health in good time before such use is to take place.
Contained use of genetically modified microorganisms (GMM) shall only take place in laboratories that have been previously applied for and approved for this use and within the framework for research activity with GMM that has been notified and approved by the Norwegian Directorate of Health. The work must be carried out and the laboratory must be designed in accordance with the regulations on contained use of GMMs.
Room manager / supervisor:
The room manager/supervisor is responsible for ensuring that areas to be used for research / teaching with contained use of GMM are applied for and approved by the Norwegian Directorate of Health in good time before such use is to take place. Contact the HSE coordinator for more information on how to proceed concretely. The use must be within the framework that has been reported / applied for and approved by the Norwegian Directorate of Health. Application is sent on a standard form. The room manager shall ensure that laboratories approved for contained use of GMMs shall be marked with a biological hazard sign in accordance with requirements from the Norwegian Directorate of Health.
Training:
The supervisor / room manager must ensure that new users are familiar with and have understood the routine for work with the contained use of GMM. The supervisor must have a protocol with an overview of those who have received such training and which levels in the laboratory they are authorized for. The protocol is located in room A1.M029. In this protocol, those who have received training must sign for.
Risk assessment:
There must be a written risk assessment of GMM work before it is started. The risk assessment must be found in the researcher's laboratory journal.
Working with GMM:
To be done according to the ‘Security Checklist - Biological Chemistry’. Wear a lab coat and gloves. Never touch door handles with gloves. Equipment must not be touched with contaminated gloves. Do not leave the laboratory area with a lab coat on.
Waste:
Biological hazardous waste must be autoclaved before it is treated as other laboratory waste. The autoclave must be cooled and without pressure when opened. Biological waste with less risk must be placed in yellow hazardous waste containers.
Accidental alertness:
Spills: Disinfect immediately with 70% alcohol contained in spray bottle. The cloth should then be autoclaved and placed in a hazardous waste container.
If you put on GMM material, it can be disinfected with 70% alcohol before washing. If GMM is spread to areas outside the approved laboratories, this must be reported to the supervisory authorities by e-mail: Postmottak.5050SPBH@helsedir.no. In case of suspicion of, or confirmed discharge that may have acute health or environmental consequences, this must be reported immediately to the Norwegian Coastal Administration via emergency number 110. All accidents must be reported as HSE deviations by using the form for reporting HSE deviations in CIM.
All laboratories at IOB are approved for the use of GMM at containment level 2.
Applications for areas / laboratories for contained use of GMM must be sent from the head of department at IOB.
For more information on the contained use of GMM, please refer to the Norwegian Directorate of Health, Department of Biotechnology and Health Law.
Regulations:
- Forskrift om innesluttet bruk av genmodifiserte mikroorganismer
- Forskrift om innesluttet bruk av genmodifiserte planter (planteforskriften)
- Forskrift om innesluttet bruk av genmodifiserte dyr (dyreforskriften)