Biosafety

Work with infectious agents refers to the intentional use of microorganisms, such as viruses or bacteria, that can cause infection in humans, in research or teaching activities. When working with infectious agents, the provisions Infection risks (Smittrisker) AFS 2018:4 of the Swedish Work Environment Authority must be followed. The provisions provide information on the risk classes (risk class 2-4) into which infectious agents are categorized based on the severity of the diseases they can cause, as well as the protective measures that must be taken at different containment levels.

When working with infectious agents that are also genetically modified microorganisms (GMMs), the provisions Enclosed Use of GMMs (Innesluten användning av GMM) AFS 2011:2 must also be complied with.

Considerations for intentional work with infectious agents

• Always contact LiU's biosafety coordinator well in advance before planning to use infectious agents or GMMs, see contact details on the right.
• Notification to the Swedish Work Environment Authority for infectious agents. Read more about the notification requirements in the section below. It's important to note that notification of infectious agents must be submitted no later than 30 days before the work starts.
• Risk assessment. A risk assessment must be conducted for all work with infectious agents, read more about this here. The risk assessment determines the protective measures required to perform the work safely and the containment level at which the work should be conducted. The provisions Infection risks (Smittrisker) AFS 2018:4 describe the necessary protective measures for each containment level.
• Facilities. Are there facilities adapted to the containment level required for the planned work with infectious agents? Adapting facilities can take a long time, so it needs to be planned well in advance. If facilities are shared with other research groups, it is important to coordinate procedures and inform all relevant parties about the planned activities. The provisions Infection risks (Smittrisker) AFS 2018:4 specify the requirements for facilities at each containment level.
• Handling and safety instructions must be available in written form for work with infectious agents. This includes both procedures for normal conditions and for unexpected events.
• Emergency response and accidents. Plan in advance for unexpected events such as spills and ventilation failure. For accidents involving risk of infection through needlestick, cut, or splash injuries, refer to LiU's procedure describing measures to be taken immediately following the incident and afterwards.
• Waste management. Find out the requirements for waste management regarding the infectious agents and other materials to be used in the work. Guidelines for waste management are described in the Laboratory Safety Manual under Laboratory waste.

Notification of infectious agents

All work with and storage of infectious agents in risk class 2-4 must be notified to the Swedish Work Environment Authority according to the provisions Infection Risks (AFS 2018:4).

The image below summarizes the requirements for notification and permits for infectious agents and GMMs.

Always contact LiU's biosafety coordinator well in advance before planning to use infectious agents, see contact details on the right.

Notification to the Swedish Work Environment Authority must be submitted 30 days before the work begins. Notification is also required for the relocation of activities, to be submitted no later than 30 days before the relocation. More information about the notification of infectious agents can be found at the Swedish Work Environment Authority's website, where a cover sheet (form) for the notification is also available.

The following elements should be included in the notification:

• Completed cover sheet with information about the use, facilities, and description of waste management.
• Risk assessment
• Written handling and safety instructions

LiU's biosafety coordinator provides information and advice regarding the notification and will also submit the notification to the Swedish Work Environment Authority (see contact details on the right). The notification/application and associated documents should be registered in the registry of the respective institution.

Work with GMM refers to the use of genetically modified microorganisms (GMMs) in research or teaching activities. A GMM is a microorganism whose genetic material has been altered in a way that does not occur naturally (through mating or natural recombination). Definitions and concepts related to GMMs are explained in regulation SFS 2000:271.

When working with GMMs, the provisions Enclosed Use of GMMs (Innesluten användning av GMM) AFS 2011:2 must be followed. For GMMs that are also infectious agents, both AFS 2011:2 and Infection Hazards AFS 2018:4 apply.

Considerations when working with GMM

• Always contact LiU's biosafety coordinator well in advance before planning to start using GMM. See contact details to the right.
• Notification or permission application to the Swedish Work Environment Authority for GMM. Read more about the requirements for notification and permission at the Swedish Work Environment Authority (Arbetsmiljöverket). It is important to note that the Swedish Work Environment Authority has a processing time that can be several months for permission cases.
• Risk assessment. A risk assessment must be conducted for all work involving GMM. You can find more information about it here. The risk assessment determines the protective measures needed to perform the work safely and the containment level required. The provisions AFS 2011:2 and AFS 2018:4 describe the required protective measures for each containment level.
• Facilities. Are there facilities adapted to the required containment level for the planned work available and where the work will be performed? Adapting facilities can take a long time, so it should be planned well in advance. If facilities are shared with other research groups, it is important to coordinate procedures and inform all parties involved about the planned activities. The provisions AFS 2011:2 describe the requirements for facilities for each containment level.
• Handling and safety instructions must be available in written form when working with infectious GMM. This includes both procedures for normal conditions and unexpected events.
• Emergency response and accidents. Plan in advance for unexpected events such as spills and ventilation failure. For accidents involving risk of infection due to needlestick, cutting, or splashing injuries, refer to LiU's procedure that describes immediate and post-incident actions.
• Waste management. Find out the requirements for waste management regarding the GMMs and other materials to be used in the work. Guidelines for waste management are described in the Laboratory Safety Manual under Laboratory waste.

Notification of GMM

All contained use of genetically modified microorganisms (GMM) must be notified to the Swedish Work Environment Authority. In some cases, permission from the Swedish Work Environment Authority is required.

Always contact LiU's biosafety coordinator well in advance before planning to start using GMM.

Forms and more information regarding the notification and permission application for GMM are available from the Swedish Work Environment Authority.

GMM is categorized into different risk groups based on the risk they pose to human health and the environment:

F-activities: involve negligible or no risk of harm to human health or the environment, work is conducted at containment level 1. F-activities require notification to the Swedish Work Environment Authority.

Examples of F-activities:

• Transfection of non-pathogenic E. coli with a plasmid encoding GFP.
• S. cerevisiae (baker's yeast) is used for cloning DNA fragments encoding non-toxic enzymes.

L-activities: involve low risk of harm to human health or the environment, work is conducted at containment level 2. L-activities require notification to the Swedish Work Environment Authority.

Examples of L-activities:

• Infection of cultured cells with a viral vector (risk class 2) for expression of desired proteins that do not pose a risk to health or the environment.
• Studies of virulence factors in Salmonella enteritidis by making deletions in coding genes.

R-activities: involve moderate or high risk of harm to human health or the environment. Work with GMM at containment level 3 and 4, as well as large-scale work at containment level 2, are categorised as R-activities. R-activities require permission for the operation.

Examples of R-activities:

• Introduction of a plasmid encoding green fluorescent protein (GFP) into M. tuberculosis to produce bacteria expressing GFP.
• Transfection of cell lines with plasmids encoding HIV-1.

The image below summarizes the requirements for notification and permission for infectious agents and GMM.

Teaching activities that involve the use of GMM need to be reported as a separate GMM activity.

LiU's biosafety coordinator provides information and advice regarding notification and permission and will also submit the notification or permit application to the Swedish Work Environment Authority (see contact details to the right). The notification/application and associated documents should be registered in the registry of the respective institution.

Risk assessment

All work involving biological agents, including infectious agents, must be risk assessed. Risk assessment also needs to be carried out for other tasks that may involve risk of infection, such as handling blood, other bodily fluids, or tissue samples.

The risk assessment is conducted systematically to identify the risks associated with the work, and the identified risks are evaluated based on the likelihood of accidents or health hazards and the potential severity of the consequences.

Infectious agents/biological agents

To assist in the risk assessment of infectious agents/biological agents, a form developed by LiU is available. Information on risk assessment can also be found in the provisions Infectious Risks (Smittrisker) AFS 2018:4 as well as from the Public Health Agency of Sweden.

GMM (Genetically Modified Microorganisms)

Risk assessment for GMM in F- and L-activities is conducted using forms provided by the Swedish Work Environment Authority in conjunction with the notification process (link to forms here). For R-activities, the risk assessment form for infectious agents should be used (a specific module for GMM is employed).

Medical check-ups

If there is risk that the worker has been or can be exposed to harmful exposure of infectious or other biological agents the employer has to offer vaccination, when this is applicable, and other medical preventive measures.

More information about medical check-ups is available in the section Safe laboratory environment.

Waste management is described on the pages Laboratory Waste.

For any uncertainties or questions regarding the handling of infectious/GMM-containing waste, please contact Biosafety Coordinator.

When working with infectious agents and GMM (Genetically Modified Microorganisms), it is necessary to have a plan in place for unexpected events. This can include spills, ventilation failures, and personal injuries such as needlestick, cutting, or splash injuries. A description of planned actions should be included in written handling and safety instructions for infectious agents and GMM.

Spill procedure

When working with infectious agents and GMM, a local procedure for spill management needs to be developed and documented in written handling and safety instructions.

Needlestick, Cutting, and Splash Injuries with the Risk of Infection

In the event of a needlestick, cutting, or splash injury involving contact with human blood, tissue, or infectious agents, it is important to cleanse the area and seek medical attention. The procedures are described in the Routine for Needlestick, Cutting, and Splash Injuries - Risk of Bloodborne or other Infections. It is advisable to refer to this routine in the risk assessment and have it readily available in the laboratory. The routine also includes a shorter instruction that can serve as a notice in the laboratory.

Serious incident involving risk of infection

In certain instances, incidents involving the risk of infection should be promptly reported to the Swedish Work Environment Authority. This applies to incidents involving the risk of infection for diseases of public concern. Examples of such diseases are:

• Campylobacter
• Hepatitis A-E
• Tuberculosis
• HIV
• Methicillin-resistant Staphylococcus aureus (MRSA)

A comprehensive list is available from the Swedish Public Health Agency

The employer must immediately report serious incidents to the Swedish Work Environment Authority. This means that the head of the department or equivalent and the HR partner should be involved in the reporting. For more information on how this is done, refer to the general section on emergiences and accidents. Further information on serious incidents involving risk of infection can be found at the Swedish Work Environment Authority.

Emergency Preparedness Plan

When working with infectious agents in risk class 3, where a release could pose a serious danger to humans, and with GMM that could pose a serious danger to the environment or people in the vicinity, a written emergency preparedness plan needs to be developed (AFS 2018 19 §, AFS 2011:2 12§). If it involves GMM, authorities that may be affected in the event of an accident should be informed about the content of the emergency preparedness plan. The procedures should be practiced annually or more frequently if necessary.

Biosecurity refers to measures taken to prevent intentional spread of infectious agents and toxins that could harm humans or the environment. This is different from the concept of biosafety, which involves work to prevent unintentional exposure or spread of infectious agents.

Biosecurity procedures aim to restrict unauthorized access, theft, or misuse of infectious agents and toxins. Biosecurity also includes protecting sensitive information about infectious agents and toxins. In activities involving the use or storage of infectious agents and toxins, it is important to incorporate biosecurity aspects. Key elements of biosecurity include responsibility, barriers, limited access, information protection, inventory management, and transport security.

Biosecurity is part of a regulated area known as export control, where legislation exists to promote non-proliferation and export control of strategically sensitive products. For more information on export control, visit Liunet. If you have any questions regarding biosecurity or export control related to biological substances, contact the biosafety coordinator. You can also find more information about biosecurity from the Public Health Agency of Sweden (Folkhälsomyndigheten).