Biosafety

Questions regarding biosafety can be directed to the institutional Biosafety Representative, KI’s Biosafety Coordinator, or KI’s Biosafety Committee.

Role of the Biosafety Representative

At every department that conducts work involving infection risks (including biological agents and genetically modified microorganisms), the Head of Department must appoint one or more Biosafety Representatives. These individuals must have experience and competence in work involving infection risks and be provided with sufficient resources and mandate to conduct systematic and preventive biosafety work at the departmental level.

The Head of Department is responsible for delegating tasks to the Biosafety Representative. More information about the Biosafety Representatives’ authority and mandate is available in the document Delegation för Biosäkerhetsombud.

The Biosafety Representative act as advisors on biosafety at the departmental level and are responsible for coordinating and reviewing matters before they are forwarded to KI’s Biosafety Coordinator for further processing. 

When laboratories or other facilities outside the home department are used, where infection risks may exist, including KI’s core facilities, it is important that the Biosafety Representative collaborates with any other relevant Biosafety Representative concerning risk assessments and the choice of protective measures. Se document Biosafety Representatives at KI´s department belowe.

Notifications or Applications for Permits

Work with microorganisms that can cause infection in humans and all work with GMMs require notification or a permit from the supervisory authority.

Work involving infectious agents and GMMs must be notified to, or permitted by, the Swedish Work Environment Authority (Arbetsmiljöverket). Before this can be done, the department’s Biosafety Representative must review the notification or application.

Thereafter, KI’s Biosafety Coordinator performs the final review and submits the documentation i.e., the notification or application, to the Swedish Work Environment Authority.

When working with biological materials where infection risks exist, such as blood and human specimens, infectious agents, or GMMs, the user must always consider the risks by conducting a risk assessment. Based on the risk assessment, the appropriate laboratory containment level, necessary personal protective equipment, and other protective measures are selected, as well as the required procedures.

Work with infectious agents and GMMs is regulated primarily by the following two regulations from the Swedish Work Environment Authority:

• AFS 2023:10 Chapter 11 – Risks of Infection
• AFS 2023:13 Chapter 9 – Contained Use of Genetically Modified Microorganisms

For more in-depth knowledge in the field of biosafety, WHO has published an informative English-language guideline. Several additional guidance documents focusing on operational aspects of biosafety are associated with the publication:

WHO Laboratory Biosafety Manual, 4th edition 2020

Risk Assessment in Relation to Biosafety

Risk assessments must be conducted to determine whether protective measures are necessary to ensure a safe working environment for everyone. The risk assessment process also increases risk awareness among those involved in the work. The Swedish Work Environment Authority’s regulation AFS 2023:10 Chapter 10 “Risks of Infection” describes how and when risk assessments must be made and documented for blood, human specimens, and microorganisms that are not genetically modified.

For risk assessments involving blood and other human specimens, the Human Sample Risk Assessment (HUMRA) form may be used. For risk assessments involving microorganisms that can cause infection in humans, the Biological Agent Risk Assessment (BARA) form is a useful tool. Both forms were developed by KI Biosafety Committee.

Work with genetically modified microorganisms must also be risk assessed. The extent of the risk assessment depends on the assessed risk level of the GMM. The work is classified under the Swedish Work Environment Authority regulations into levels F, L, or R, where R indicates the highest risk level. Risk assessments for GMMs are performed using the authority’s forms. For a description of the requirements for GMMs, see AFS 2023:13 Chapter 9.

Infection Risks when Handling Blood

Handling blood in a laboratory environment may pose a risk, and all handling of human blood and other human specimens, such as tissue and primary cultures, is regulated by AFS 2023:10 Chapter 11 Risks of Infection. The main rule is to treat all blood and blood contaminated materials as infectious. Note that infections such as hepatitis B, C, or HIV can be transmitted not only through blood handling but also through materials contaminated with blood, such as tissue, wound fluid, cerebrospinal fluid, urine, pipette tips, and similar items. Cell cultures can also present such infection risks.

No special permit from the Swedish Work Environment Authority is required for handling blood, but the laboratory must meet at least containment level 2 depending on the risk assessment. For handling or working with microorganisms in risk class 2 and above, notification or permit is required.

See Guidelines for handling blood and other human specimens at Karolinska Institutet under the heading “Regulatory document”, below.

Notification, Permit, and Risk Assessment – Microorganisms

Microorganisms are divided into four risk classes, 1, 2, 3, and 4, based on their ability to cause infection and the severity of possible consequences. The classification is based on laboratory work with biological agents, where work with higher risk classes entails higher risk. Microorganisms that normally do not cause infectious disease are classified as risk class 1, though they may still cause ill health through hypersensitivity or toxin production.

The regulation AFS 2023:10 Chapter 11 includes a classification list of common microorganisms in risk classes 2-4.

Handling or working with microorganisms in risk classes 2-4, so-called pathogens, can cause infection and disease in humans and must always be risk assessed.

Microorganisms in risk class 1 require a risk assessment only if the user believes that the work may present an infection risk.

KI’s BARA form can be used for risk assessment of microorganisms. The form is divided into two parts: Part A characterizes the microorganism, and Part B describes handling, exposure risks, and protective measures. Part B can be used both for laboratory work (B1) and for handling microorganisms in animal experiments (B2).

Handling microorganisms in risk classes 2-4 requires notification to the Swedish Work Environment Authority.

For questions regarding risk classification, contact KI’s Biosafety Coordinator.

Exceptions from notification requirements apply to diagnostic activities where handling involves only the original patient sample, such as chemical analysis without enrichment. Research activities involving risk class 2 microorganisms and above nearly always require notification.

At workplaces with a permit or approved notification for handling infectious microorganisms, the following applies:

• Handling instructions established in connection with the notification must be followed.
• Only individuals informed about the risks and adequately trained may work there.
• Work may only occur in approved facilities.
• Facilities must be properly labelled (containment level 2, biohazard symbol, access restrictions if applicable).
• Documentation related to the notification, including current risk assessments, must be easily accessible, e.g. in the laboratory binder.

When submitting a notification, the microorganisms to be used must be defined. If additional microorganisms need to be handled in the same laboratory, or if the notification needs updating, amendments are required.

Information on notification requirements is found in AFS 2023:10 and on the Swedish Work Environment Authority’s website.

At KI, departmental Biosafety Representative provides guidance, and KI’s Biosafety Coordinator is contacted as needed. All draft notifications are sent to the KI’s Biosafety Coordinator for review. Once all documentation is completed, the KI’s Biosafety Coordinator submits it to the Swedish Work Environment Authority.

Note that the department must be aware of which microorganisms at containment level 2 and above are being handled, via the Biosafety Representative. Secure storage of infectious agents and other sensitive materials is part of biosecurity. 

Read more on the page Biosecurity.

During safety inspections or visits from the Swedish Work Environment Authority, documentation related to the permit, including all attached risk assessments, guidelines, checklists, and handling instructions, must be available.

Notification, Permit, and Risk Assessment – Genetically Modified Microorganisms

A genetically modified microorganism (GMM) is defined as a microorganism whose genetic material has been altered in a way that does not occur naturally through mating or natural recombination (SFS 2000:271).

All activities involving GMMs must be risk assessed and either notified to or permitted by the Swedish Work Environment Authority. This is done via KI’s Biosafety Coordinator and in consultation with the departmental Biosafety Representative. For GMMs that may pose a risk, each use must also be notified to the authority.

Information on GMMs is available on the Swedish Work Environment Authority’s website and in AFS 2023:13 Chapter 9 Contained Use of Genetically Modified Microorganisms.

More information is available on the page Notification, permits, and risk assessment of GMMs.

Protective Measures in Biosafety

Which protective measures should be taken when handling biological materials depends on how the material will be handled and how the infectious agents it contains, or is suspected to contain, are transmitted. Biological and chemical materials are often handled simultaneously, which must be considered.

Protective measures must be defined during the risk assessment as part of the risk management process. The selected protective measures must then be implemented as written procedures, ensuring that everyone in the laboratory works consistently to reduce infection risks.

Vaccinations

More information can be found in Guidelines for vaccination of employees at Karolinska Institutet, on the page Vaccination.

Protective Clothing and Gloves

Protective clothing, such as a laboratory coat, must always be worn during microbiological work. It must be removed when leaving the work area. When transporting microorganisms within the department through public spaces, the microorganisms must be placed in a transport container, and protective clothing must be removed.

The risk assessment determines whether protective gloves are required and, if so, which type. When selecting gloves for microbiological work, both penetration resistance and cut/puncture resistance must be considered.

More information on protective gloves is available in the document Protective gloves and in the  Guidelines for the handling of blood and other human samples.

Ventilated Workstations

Whether ventilated workstations are needed, and which type, must be determined by the risk assessment for the experiment.

More information is available on the page Ventilated Workstations.

Other Methods for Protection Against Infection

If airborne transmission can be excluded, splash protection may still be required, such as a plexiglass shield. Other splash protection includes visors or safety goggles. The risk assessment determines the appropriate protection. In such cases, laboratory fume hoods also often provide suitable protection.

Handling Spills

In the event of a spill involving biological material, it is important to take rapid action to prevent harm to staff or the environment. The following steps must be followed:

1. Inform Others
   Notify others in the area if several people are present.
2. Restrict the Area
   This can be done by closing a door and placing a sign, tape, or similar. For spills inside a biological safety cabinet, this step is typically not needed. For contaminated centrifuges or incubators, close the lid/door to allow any aerosols to settle before cleaning according to steps 2-4.
3. Leave the Area
   Leaving the area for a few minutes prevents exposure to aerosols, which take time to settle.
4. Consult the Risk Assessment if Needed
   This may be necessary to determine an appropriate disinfectant or find other information related to the biological material or infectious agent. Note that the disinfectant must be proven effective against the agent in question.
5. Consult Healthcare or Others if Needed
   Contact an infectious disease specialist, the Biosafety Representative, or KI’s Biosafety Coordinator if advice is needed.
6. Decontaminate
   Decontamination may be performed by the person affected by the spill, if possible, with assistance from others if needed. N.B. Never allow service or cleaning staff to perform decontamination, as they lack the necessary expertise.
   The risk assessment contains information on effective disinfectants for the agent involved. Generally, the area should be covered with paper towels, and a disinfectant poured over the towels. Sufficient contact time, typically 5 to10 minutes, is necessary. The material is then handled as infectious.
   The surface is disinfected again and then cleaned using a non-oxidizing chemical such as ethanol or detergent. Blood has buffering capacity, so ethanol is insufficient; use Virkon, hypochlorite, or equivalent.
7. Report the Incident
   Any incident must be reported in KI’s Incident Reporting System; see page Report incidents for more information. For chemical spills, see page Chemical Safety.

Biosecurity

Biosecurity represents one of two complementary areas in biological risk management. It comprises measures that prevent unauthorized access to, for example, KI laboratories, biological materials, and data related to these. Biosecurity also involves protecting sensitive information (see Information Security for more).

Laboratories must have access restrictions, and certain areas and equipment must be locked. KI’s security protection describes how KI works to safeguard security-sensitive activities or information against espionage, sabotage, terrorism, and other threats (see Security Protection).

Another important aspect of biosecurity is creating a strong security culture, where staff reliability and a good social working environment are key factors.

Read more on the page Biosecurity.