Working with infectious agents
Definition of infectious agents, cf. Regulations on infectious agents § 3:
These are substances that contain or can contain pathogens. Pathogens are microorganisms including bacteria, virus, Ricketts, parasites, fungus, also recombinant, hybrid or mutated organisms that are known or likely to cause disease in people who are exposed to them.
The Directorate for the safety of society and emergencies (dsb in Norwegian) cf. World Health Organization describes infectious biological substances as:
- Cultures of microorganism and biological poisons / toxins
- All samples taken from humans and animals
- Biological products that are manufactured by living organisms
- GMO and GMM that are infectious after modification
- Waste generated from the treatment of people and animals (with some exceptions)
- Laboratory waste
1 Instruction for working with infectious substances
Before working with infectious agents can begin the following must be in place
- Carry out a risk assessment
- Report to /inform the committee for biosafety; email@example.com. This applies to biological factors in risk group 2, 3 and 4 cf. Regulations on precautions and limiting values, attachment 2.
- Inform the Norwegian Labour and Inspection Authority at least 30 days before the infectious substance is to be used. This applies to biological factors in risk group 2, 3 and 4 cf. Regulations on precautions and limiting values, attachment 2.
- Evaluate and implement the necessary safety precautions
- Implement procedures for working to include
- Safety routines, registration of the safety datasheet in EcoOnline cf. Regulations on performance of the work 2-1 and information on the requirement to register those who are (potentially) exposed (EcoExposure).
- Measures in case of accidents and unforeseen exposure.
- Routines for waste handling.
- Implement health monitoring if the risk assessment indicates that the health or safety of the person exposed is put in danger (EEA appendix no. 12/239 article 3 and 14). Occupational health care at UiB with suggest and advise on protection and safety measures.
- Rule on execution of work chapter 6 (in Norwegian) for more information.
Execution of work should follow current guidelines and principles:
- Guidelines for working with biological factors
- Local procedures, cf. above
- Good hygiene and sterile technique
- Respect the risk of infection
1.1 Control of immunity and vaccination:
Risks and measures must be discussed in order to reduce the risk of infection and safeguard employees who should feel safe in the workplace.
Employees should have adequate information of the infectious substance. The risk each employee is exposed to must be thoroughly investigated, in addition to the possibility for vaccination and treatment with possible infection.
Before being exposed each employee should:
- Be tested for previous exposure and immunity
- Be offered a vaccine if it is available
Those who are going to be working with risk factors, such as infectious material, must have the correct training in general sterile technique and more specific training for pathogens. Training must include documented practical training.
Employees cannot work without supervision before they are completed their training and shown that they are competent in the following:
- Basic training and understanding of sterile working, hygiene and protective equipment /clothing.
- Understanding the documentation. For example, SOPs and information on the infectious material.
- Approved practical training and understanding of biosafety procedures associated with this type of work.
- Regular updates and attend courses on offer, etc.
For more information see Biological Factors in the HSE portal.
2. Instruction for the importation of infectious goods
Application for dispensation for admittance and work with infectious material
In order to ensure the lowest risk of infection with the importation of pathogens dangerous to humans according to the law on infectious material § 5 it is forbidden to import infectious material that
- May contain an infection normally not found in Norway
- May result in the spread of a dangerous infectious disease
It is possible to apply for dispensation for this ban cf. Law on dangerous materials (in Norwegian) §6.
1: Before one can import dangerous goods, the following are necessary
- Clearance from the committee for biosafety; firstname.lastname@example.org
- Dispensation from The Norwegian Board of Health
- Remember to ask for the approval to be written in both Norwegian and English
Dispensation may be applied for
- A department or laboratory for a finite time-period
- For certain goods / materials
- For a single experiment.
2: Applicants must
- Send a copy of the approval to the committee for biosafety; email@example.com
- Register dangerous goods in EcoOnline upon receipt, and inform the HSE coordinator.
- Ensure that those receiving delivery of dangerous goods know how it to handle it based on category, see Classification.
Classification of dangerous goods:
Infectious material is classified as dangerous goods class 6.2 (infectious alien substances), which is divided into categories A and B
Category A: All biological material, including waste, that contains microorganisms, that on exposure can cause permanent handicap, life-threatening or deadly disease in humans. Cultures of most microorganisms are usually class 3 and all infectious agents in class 4 belong to category A. See the list in “Annex 3” page 48, of the WHO guidelines.
Category B: All other biological material, including microorganisms in risk classes 1 and 2.
Labelling of infectious substances:
Category A: Infectious substances in category A are classified as dangerous goods and labelled with the warning label for Dangerous goods 6.2 (see image) in accordance with National guidelines (in Norwegian) and labelled as:
«UN 2814» also «infectious substances affecting humans»
Category B: Infectious substances in category B are labelled
«UN3373» also “Biological substance Category B»
3. Juridical principles