Biological factors and genetically modified microorganisms

Microorganisms are found everywhere: in laboratories, industry, when dealing with patients or working with laboratory animals and fish, when travelling or sorting waste, on infected syringe needles and in the indoor climate, to name but a few places.

The vast majority are harmless and, indeed, essential; even so, many microorganisms can cause damage to health, illnesses and allergies.

This depends on:

• the harmful properties of the microorganism
• the quantity of microorganisms in the workplace
• the spread of microorganisms in the workplace
• how they enter the body
• the individual employee’s susceptibility to the microorganism

Training should include information on which microorganisms employees may be exposed to and what damage to health may result from such exposure.

It should also include the importance of personal hygiene and cleaning of the workplace, and the use and handling of work clothing and personal protective equipment. Written procedures in the event of an accident must be drawn up and readily available. Information must be provided on measures to prevent and reduce exposure. Information must also be provided on health examinations and vaccination if a risk assessment shows that the person is exposed to biological factors.

Good hygiene is important to prevent infection between sources of infection and people. Good hygiene here means both that you should not eat or drink in the laboratory in addition to good hand hygiene, and that we should not have things in the laboratory that we do not clean "on site" before we take it out of the classified lab. It applies, among other things, to clothes and mobile phones.

For hazardous biological material, information sheets must be prepared containing information on name, supplier, health-damaging properties, risk of infection, risk factors, preventive measures and first aid. Optionally, you can use the Chemical Inventory, where you can create information sheets (see link on the HSE-gateway).

If the employee is or has been exposed to biological factors in infection risk groups 3 and 4, this must be registered in a register. The register must contain information about name, social security number, type of work and which biological factor. The register must be kept for at least 40 years after the exposure has ceased. Optionally, the exposure register can be used (see link to the chemical inventory on the HSE-gateway).

A risk assessment must be carried out on all work that involves biological factors. The risk assessment should take into account:

• exposure
• safe storage
• the biological factors that may be present
• toxic/harmful substances
• the infection risk group
• information on illness caused by the biological factors
• the likelihood of damage to health
• any knowledge that a proven illness may be directly connected to the work
• recommended precautions and safety measures
• the possibility of theft of biological factors

The University has a form for risk assessing of GMO.

Where the risk assessment shows that the employee may have been exposed to biological factors that are hazardous to health in such a way that more than the normal hygiene precautions are required; in this case, the employee must undergo a suitable health examination.

Notify (by letter) the Norwegian Labour Inspection Authority (NO) not less than 30 days before the unit begins to use biological factors in infection risk groups 2, 3 and 4. The purpose of giving notice is so that the Authority knows that a risk assessment has been carried out and that there are plans to initiate measures to protect the employees. On the Labour Inspection Authority's website, there is a separate form for submitting information (NO). If the Norwegian Labor Inspection Authority has comments on the report, they will respond within 30 days.

• Before ordering infectious agents (NO) from aborad, the permit must be approved:
  • To be cleared with the committee for biosafety, contact the person responsible for biological factors at your unit.
  • Apply for a dispensation to the Directorate of Health.
  • Remember to ask for the sertificate to be written in Norwegian and English, as this is often required when ordering such material.
  • Regulation on infectious material (NO)

If the unit buys in cell lines, human material or mice/rats from non-ordinary suppliers, the material must be checked for infectious human pathogens. This can be checked by PCR.

Larger quantities of liquid biological waste must either be autoclaved and delivered as problematic waste, or added virkon and delivered as problematic waste. Smaller quantities (eppendorf tubes and falcon tubes) can be delivered directly as problematic waste. The liquid waste must be packaged in a leak-proof container (e.g. tube or bottle with a screw cap) and then in a yellow waste container.

Solid waste (e.g. agar plates) is disposed of directly in a yellow waste container as problematic waste. 

Biological samples containing antibiotics are treated as liquid/solid biological waste and delivered as problematic waste.

GMOs do not include organisms where the genetic composition has been altered using conventional (traditional) crossing or by mutagenesis. (Mutagenesis involves the use of chemicals or irradiation to produce changes in DNA.)

In principle, all organisms can be genetically modified, and the methods used to introduce the desired DNA will vary from one species to another. Microorganisms are easy to cultivate in large quantities and are relatively easy to modify genetically. Genetically modified bacteria are used for research and for manufacturing genes, gene fragments, vitamins and proteins. GMOs also form part of some industrial processes, for example in the food and drink industry.

For more information about genetically modified microorganisms, please see the Norwegian Biotechnology Advisory Board’s web pages (NO).

An activity is categorised in one of four classes, each with an associated containment level:

• Class 1. Activities involving no risk, or only an insignificant risk, with containment level 1.
• Class 2. Activities involving a low risk, with containment level 2.
• Class 3. Activities involving a moderate risk, with containment level 3.
• Class 4. Activities involving a high risk, with containment level 4.

Applications for GMO approval of laboratories requiring containment levels 1 and 2 must be made no later than 45 days before the start of work. Applications for GMO approval of laboratories requiring containment levels 3 and 4 must be made no later than 90 days before the start of work. The approval body is the Norwegian Directorate of Health.

The Norwegian Directorate of Health has prepared a new GMO portal that will be used to send applications and notifications about the contained use of genetically modified organisms to the Norwegian Directorate of Health: the GMO portal.

For easier assessment and classification of risk, you can use this registration / reporting form. The chemical inventory can also be used (see link on the HSE-gateway).

Releases or other accidents while using GMOs:

• The Norwegian Directorate of Health must be notified immediately. Contact the Department for pharmaceuticals and biomedicine on email GMO-boksen@helsedir.no.
• Reported as an HSE non-conformance via HelpUiB.

Larger quantities of liquid biological waste (GMO) must either be autoclaved and delivered as problematic waste, or added virkon and delivered as problematic waste. Smaller quantities (eppendorf tubes and falcon tubes) can be delivered directly as problematic waste. The liquid waste must be packaged in a leak-proof container (e.g. tube or bottle with a screw cap) and then in a yellow waste container.

Solid waste (e.g. agar plates) is disposed of directly in a yellow waste container as problematic waste. Solid biological waste that has been in contact with GMO viruses must be inactivated with virkon before disposal.

Biological samples containing antibiotics are treated as liquid/solid biological waste and delivered as problematic waste.

If the employee is or has been exposed to biological risk factors in infection risk groups 3 and 4, this must be registered in a register. The register must contain information on name, birth number, type of work and which biological factor. The register must be kept for at least 40 years after the exposure has ceased. If necessary, the chemical inventory can be used (see link on the HSE-gateway).

UiB has prepared a separate form for risk assessment of GMOs.

If the activity poses a risk to the employee's health or safety, the exposure must be mapped and a risk assessment must be made of how the exposure takes place.

Useful information if you are unlucky and get a stab, cut og bite injury

For hazardous biological material, information sheets must be prepared containing information about

• name,
• supplier,
• health-damaging properties,
• risk of infection,
• risk factors,
• preventive measures,
• first aid.

UiB has developet a reporting form that can be used. The chemical inventory can also be used (see link on the HSE-gateway).

A biosafety committee has been established. The committee shall be an advisory entity at UiB in connection with the use of biological risk factors and genetically modified organisms. The committee shall advise units in connection with approvals and applications, ensure that regulations are updated at all times, and assist with questions about risk assessment.

Guidelines relating to biological risk factors

Guideline for genetically modifies organisms