Guidelines relating to biological risk factors

Norwegian version

Approved by the University Director on 10 December 2020.

1. Purpose

The aim of these guidelines is to help ensure that everyone who uses and handles biological risk factors at the University of Bergen does so in a safe and proper manner.

2. Scope

The guidelines apply to all work with biological risk factors at and under the governance of the University of Bergen. When employees with different employers share premises or take part in joint activities, the enterprises shall coordinate HSE work in order to ensure a thoroughly sound working environment (section 2-2 of the Norwegian Working Environment Act).

3. RESPONSIBILITIES

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

  • Employees, students, and guest researchers who use and handle biological risk factors shall follow the guidelines.

4. Definitions

Line manager: Head of Department, division manager or equivalent, who has overall responsibility for the unit.

Biological risk factors: Living or dead biological material (such as bacteria, fungi, parasites, cell cultures, virus, prions, toxins, and allergens) that may have harmful effects (such as infections, allergic reactions, or poisoning) for humans or the environment (such as animals or plants).

Microorganisms: Any cellular or non-cellular microbiological entity that can reproduce itself or transferring genetic material, also including viruses, viroids, animal and plant cells in culture. Infection risk group: Classification of living biological risk factors according to the risk of infection they represent in accordance with section 6-1 of the Regulations concerning measures and thresholds.

Containment measures: Measures or barriers used to prevent the biological risk factor coming into contact or causing harm to humans or the environment. These may be physical barriers (such as underpressure in the laboratory) or biological barriers (conditions that prevent the biological risk factor from causing harm outside a contained area, such as an organism that cannot reproduce outside the laboratory due to low temperatures).

5. Organisation and approvals

5.1 Approval

Committee for biosecurity

  • An advisory committee at the University of Bergen, for the introduction and use of biological risk factors including GMOs.

The line manager shall:

  • Ensure that a report is submitted to the Norwegian Labour Inspection Authority minimum 30 days before the unit starts using biological risk factors in infection risk groups 2, 3 and 4, and ensure that the workplace has a sufficient level of containment. This report requires the approval of the committee for biosecurity before it is submitted.

  • 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.

5.2 Organisation

The line manager shall ensure that:

  • All work involving biological risk factors is subject to a risk assessment.

  • Employees who may be exposed to hazardous biological risk factors are informed of the risk and have an appropriate medical examination.

  • Working instructions, procedures and routines are prepared for storage, handling, transport and waste management, and the persons involved are familiar with these.

  • Sufficient training and knowledge have been provided prior to starting work with biological risk factors. The training must be documented.

  • Necessary safety measures and appropriate protective equipment are available and used correctly.

  • Hygiene measures are followed.

  • Emergency plans are prepared for unexpected exposure to biological risk factors.

  • A list is kept of all employees who are or have been exposed to biological risk factors in infection risk group 3 or 4.

  • Serious injuries and illness that could be caused by the work shall be reported to the Norwegian Labour Inspection Authority.

5.3 Procurement

  • Prior to procurement (purchase, import and/or collection), the approval specified in section 5.1 must have been obtained.

5.4 Registration

Biological risk factors shall be registered:

  • Biological risk factors

  • For hazardous biological material, information sheets must be prepared which must contain at least the following information:

    • name,

    • information about manufacturer, importer and / or seller,

    • harmful properties / toxicological data,

    • information on risk of infection,

    • risk factors,

    • preventive protection measures and

    • first aid treatment.

  • If it is not relevant or technically possible to provide one or more of the information required by this provision, the reasons shall appear from the information in the substance register.

5.5 Use, handling, and storage

The line manager shall ensure that employees, students, and guest researchers meet the following requirements:

  • Sufficient training and knowledge have been provided prior to starting work with biological risk factors.

  • Fully informed of general risk assessments and carry out risk assessment of own procedures (in relation to e.g., infection risk group.

  • Follow the relevant work instructions.

  • Work is performed in approved laboratories.

  • Appropriate protective equipment is used.

  • Report HSE nonconformances in accordance with the Guidelines for reporting and follow-up of HSE non-conformities.

5.6 Waste management for biological waste