Procedure for working with GMO-animals

Responsibility

Head of Department has the overall responsibility for ensuring that all work with GMO-animals and GMM+animals at IBV takes placed in controlled, approved laboratories, and that all such activities are according to the approvals given by the Norwegian Directorate of Health. Also, all research and teaching activity with GMO-animals and GMM+animals shall be in accordance with notifications/applications sent to The Norwegian Directorate of Health and the Norwegian Labour Inspection Authority. All such notifications and applications shall be signed by the Head of Department. The Head of Department must ensure the dissemination of this procedure to relevant staff and students. 

Section leader/lab manager shall ensure that the facilities used for activities as described above are applied for and approved prior to the onset of such activities. The activity shall be within the approval limitations. 

Users are responsible for following this procedure and ensure that all use of GMO-animals and GMM+animals are according to the legislation. Users are responsible that the research is risk assessed, that safety measures are described and preparedness actions are formulated. All adverse events with GMO-animals or GMM+animals should be reported according to procedure for adverse events.

Method

All work with GMO-animals or GMM+animals must be reported to the Norwegian Directorate of Health (Helsedirektoratet) before the animals are introduced into the approved area. Applications and notifications are to be sent by the Departments administration. The Norwegian Labour Inspection Authority shall be notified before onset of work with biological factors. 

Working with GMO-animals and GMM+animals and waste handling in InVivo facility (applies to mice, rats and zebrafish)

1. Only approved rooms can be used. All husbandry and use of GMO-animals andGMM+animals shall be kept within the approved facilities. 
2. All use and introduction of GMO-animals or GMM+animals must be approved before introduction and before they are given a designated area.
3. All work with GMO-animals and GMM+animals shall be recorded in a lab-journal.
4. User must commit to all laws, regulatios and local policies for use and husbandry of GMO-animals and GMM+animals.
5. The Head of the InVivo facility shall be notified of all planned introduction of GMO-animals and GMM+animals into the InVivo facility in advance, and will decide on approval for introduction.
6. As a main rule, all housing and breeding of GMO-animals require approval from the Norwegian Food Safety Authority. Confer with the Head of InVivo facility about this. 
7. In case of adverse events with accidental escape this should be immediately reported to the Head of InVivo facility and the Norwegian Directorate of Health (Helsedirektoratet).
8. All waste and carcasses shall be disposed in designated, closed risk wast containers for combustion of hazardous waste. Training in waste handling will be given to each person before being granted access to the area. 

Safety measures implemented to limit accidental escape of zebrafish (GMO-animals and GMM+animals)

1. All zebrafish are kept in enclosed tanks (or petri dishes) in a enclosed system (an incubator).
2. The drain in the floors have filters to prevent escape of fish in the adverse event of spilling water of the floor. The drain water from GMO-fish and GMM+fish is chlorinated.
3. Carcasses and other waste are disposed as risk waste in closed containers. 
4. In an adverse event of accidental escape this should be immediately reported to the Head of the InVivo facility and the Norwegian Directorate of Health (Helsedirektoratet).

Safey measures implemented to limit accidental escape of GMO-animals and GMM+animals (mice and rats)

1. The InVivo facilitys rodent area have walls and floors with no opening to limit accidental escape of animals (drains are secured from rodent escape/entry).
2. The ventilation shafts have grates with filters. 
3. The doors have automatic shutter mechanism and are always closed.
4. The drain pipes are secured with grates.
5. The animals are housed in sealed, individually ventilated cages with HEPA-filters.
6. Considerations have been made to ensure that no other organisms in the environment can be influenced by the research animals .
7. Only authorised personell have access to the rodent InVivo facility. Access by card and code.
8. Outside normal working hours the security operation centre has security guard that inspect the doors and that can alert irregularities like sabotage and burglary.
9. The animals facility have sluices as extra safety measures to prevent escape.
10. Rodent barriers are used when needed.
11. All transportat of animals must  take place in accordance with an SOP.
12. The husbandry parameters may be adjusted in connection with the various experiment requirements.
13. The doors to the rodent InVivo facility are closed.
14. All GMO-animal and GMM+animal waste, including bedding and carcasses, are disposed in sealed risk waste containers and are handled by the provider of waste services.
15. The rooms are signposted according to regulations.
16. In an adverse event of accidental escape this should be immediately reported to the Head of the InVivo facility and the Norwegian Directorate of Health (Helsedirektoratet)

Important procedures when working with GMOs

Procedure for laboratory safety; management of work with chemicals, biological agents, genetically modified microorganisms and sources of radiation

Procedure for working with genetically modified organisms (GMO)

Procedure for work with Biological substances

Tools

The Norwegian Directorate of Health; Application and report forms (Søknads- og rapporteringsskjema)

Attachment  1C GMM; inneslutningstiltak 1 for laboratoriet

Attachment 1C GMM; inneslutningstiltak 2 for laboratoriet

Attachment 1E GMM + dyr; godkjenning arealer

Attachment 1F GMM + dyr; inneslutningstiltak 1 og 2 for laboratoriet

Attachment 3 og 4 GMM; Risk assessment (risikovurdering)

Attachment 5 GMM; General safety (alminnelige sikkerhetstiltak)

References

Arbeidsmiljøloven, §§ 1, 7, 8, 9, 11 og 14

Følgende av Arbeidstilsynets forskrifter og veiledninger (regelverk under Arbeidsmiljøloven):

• Forskrift om tiltaksverdier og grenseverdier for fysiske og kjemiske faktorer i arbeidsmiljøet samt smitterisikogrupper for biologiske faktorer (forskrift om tiltaks- og grenseverdier) (FOR-2011-12-06-1358)
• Forskrift om utførelse av arbeid, bruk av arbeidsutstyr og tilhørende tekniske krav (forskrift om utførelse av arbeid) (FOR-2011-12-06-1357)
• Forskrift om utforming og innretning av arbeidsplasser og arbeidslokaler (arbeidsplassforskriften) (FOR-2011-12-06-1356)
• Lov om framstilling og bruk av genmodifiserte organismer (genteknologiloven; LOV-1993-04-02-38), med tilhørende forskrifter og skjemaer:
  • Forskrift om innesluttet bruk av genmodifiserte dyr (dyreforskriften) (FOR-2001-12-21-1602)
  • Forskrift om bruk av genmodifiserte mikroorganismer (FOR-2001-12-21-1600)
  • Forskrift om bestemte former for undervisningsvirksomhet som innebærer innesluttet bruk av genmodifiserte mikroorganismer (FOR-2001-12-21-1601)
  • Forskrift om transport og import av genmodifiserte organismer (FOR 2005-09-02-1009 Kap. 2 § 7)
  • Forskrift om konsekvensutredning etter genteknologiloven (FOR-2005-12-16-1495)

Animal Welfare Act (LOV-2018-04-10-4), and regulations :

• Forskrift om bruk av dyr i forsøk (FOR-2017-04-05-451) 
• European convention for the protection of vertebrate animals used for experimental and other scientific purposes (Europarådets forsøksdyrkonvensjon av 18 juni  2007) , med tilhørende vedlegg: Appendiks A - Guidelines for accomodation and care of animals
• Hunskaar, S og Fosse, RT (1990) Allergy to mice and rats: a review of the pathophysiology, epidemiology and clinical aspects. Laboratory Animals 24, 358-374
• For more information, see the web pages from the Norwegian Health Directorate (Se Helsedirektoratets sider.)

Last major update: 03.07.2018. Changes since previous version: Revision of the whole procedure in accordance with new routines and latest application for approval pr June 2018.