Guidelines for biological factors and genetically modified microorganisms

Approved by the University Director 21.08.2014

1. Objective

The guidelines shall contribute to ensuring that everyone who uses and handles biological factors and genetically modified microorganisms (GMO) at the University of Bergen (UiB) does this in a safe and prudent manner.

2. Basis

The guidelines are included in the university's collection of rules (Part 3. Human Resources and HSE) and are based on HSE legislation (see reference).

3. Scope and area of application

The guidelines apply to all work with biological factors and GMO at and under the direction of UiB, with the exception of the projects and activities which in accordance with coordination agreements shall follow other guidelines for HSE work.

4. Responsibility

The line manager is responsible for the guidelines being known and followed up by the unit.

Employees, students and guests who use and handle biological factors and GMO shall follow the guidelines.

5. Definitions

  • Line manager: Head of Department, or equivalent, who has overall responsibility for the unit
  • Line manager's representative: Employee who has been delegated tasks by the line manager (as project manager, HSE coordinator, group manager, person responsible).
  • Biological factors: Living or dead microorganisms, cell cultures, endoparasites and prions that can cause infections, allergies or toxic effects in people.
  • Microorganisms: Any cellular or non-cellular microbiological entity that is capable of reproducing itself or transferring genetic material, also including viruses, viroids, animal and plant cells in culture.
  • Genetically modified microorganisms (GMO): Microorganisms, plants and animals whose genetic material has been altered using genetic and cellular technologies.
  • Genetic technology: Techniques that involve genetic material being isolated, characterised, modified and inserted into living cells or viruses.
  • Cellular technology: Techniques for producing living cells with new combinations of genetic material by merging two or more cells.
  • Infection risk group: Classification of living biological factors according to the risk of infection they represent in accordance with the regulation on measures and thresholds § 6-1.
  • Containment of biological factors: Barriers that are applied to prevent biological factors from coming into unintentional contact with people or the environment.
  • Containment measures: Implementing various measures to limit spread of the biological factor.

6. Organisation

6.1 Organisation and approvals

Line manager/line manager's representative shall:

  • Notify the Norwegian Labour Inspection Authority at least 30 days before the unit starts using biological factors in infection risk group 2, 3 and 4. The purpose of the notifications is that the Norwegian Labour Inspection Authority will know that a risk assessment has been conducted, and that plans have been made to initiate measures to protect the employees.
  • Apply for GMO approval of the laboratory with containment level 1 and 2 at least 45 days prior to work commencing. Laboratories that require containment level 3 and 4 shall have approval within 90 days. The Norwegian Directorate of Health is the authority granting the approval.
  • Prepare work instructions and procedures for use, transport and disposal and make these known.
  • Ensure that employees/students who are or have been exposed to biological factors in infection risk group 3 or 4 are registered in the Exposure register.
  • Based on a risk assessment, ensure that employees, students and guest researchers who are exposed to biological factors are informed about and undergo a suitable medical examination with an offer of vaccination.
  • Prior to work on biological factors and GMO ensure that sufficient training and knowledge have been provided. This must be documented in writing.
  • Ensure that the required protective equipment is available and is used.
  • Ensure that the hygiene measures are followed.

6.2 Procurement

Employees, students and guests shall:

  • Collect information on the use, handling, storage, practice in the case of spills and disposal of biological factors and GMO, and familiarise themselves with containment measures prior to procurement.

The orderer shall:

  • Order the biological factor and GMO.

6.3 Use, handling and storage

Employees, students and guests shall:

  • Conduct a risk assessment of the procedure/project in accordance with "Guidelines for risk assessment of hazardous working environments".
  • Follow the relevant work instructions.
  • Use safety cabinets class IIB2 or III when working with biological factors in infection risk group 3 and 4.
  • Use the required protective equipment.
  • Ensure that chemicals are labeled according to the Declaration Regulations, and stored in approved cupboards in locked storage rooms.
  • In the event of an accident with GMO immediately inform the Norwegian Directorate of Health.
  • Report the HSE non-conformities that is discovered in accordance with "Guidelines for reporting and following up HSE non-conformities".

6.4 Waste management

  • Biological waste:
    • Liquid waste with biological factors is autoclaved and thereafter disposed in accordance with "Guideline for disposal of hazardous waste and problematic waste, ionizing sources of radiation and explosive waste". If the waste contains hazardous chemicals, it must be reviewed every time whether it should be disposed of as hazardous waste or problematic waste.
    • Solid waste is autoclaved and treated as residual waste if it does not contain chemical residues.
  • Waste containing chemical residues must be treated as hazardous waste.
  • Waste from the use of GMO must be autoclaved before being disposed of as problematic waste.

7. References

Drawn up by: The HSE Section, Division of Human Resources
Adopted by: The Working Environment Committee 19.02.2014

Show revision history
Date Comment Entered by
Monday 14 October 2019 8:17:30 am Updating chapter 6.2 Olaug Eiksund
Monday 14 October 2019 8:16:32 am Updating chapter 7. Olaug Eiksund
Monday 06 November 2017 10:51:45 am Updating chapter 7. Olaug Eiksund
Tuesday 31 October 2017 2:34:53 pm Updating bullet point list in 6.4 Olaug Eiksund
Tuesday 31 October 2017 2:34:25 pm Updating bullet point list in 6.3 Olaug Eiksund
Tuesday 31 October 2017 12:51:13 pm Updating bullet point list in 6.3 Olaug Eiksund
Tuesday 31 October 2017 12:50:12 pm Updating chapter 7. Olaug Eiksund
Tuesday 03 October 2017 5:34:06 pm Updating chapter 7. Olaug Eiksund
Thursday 03 November 2016 1:17:39 pm Url to the Exposure register added in 6.1 Olaug Eiksund
Thursday 03 November 2016 1:15:10 pm Updating chapter 7. References Olaug Eiksund
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