Biosafety

Biologiska risker

Biological risks can be infectious substances, genetically modified microorganisms (GMM), blood & tissue, research animals, invasive species, or waste thereof, which can have a detrimental impact on human health or the environment at large.

There is always a risk of infection when working with tissue, bodily fluids, or pure infectious agents, especially so during aerosol formation, and work with needles and scalpels. Vaccination can be a good complement to the regular protective measures taken. It is however important to remember that vaccination does not have 100% efficacy.

The general guideline is that all those how work with human tissue or bodily fluids should be vaccinated against Hepatitis A & B. The need for vaccination is however always determined by the employee and closest supervisor through a risk assessment.

The following aspects should be included in the risk assessment:

• The infectious substance
• The type of work
• The health status of the employee
• The efficacy of the vaccine
• The side effects of the vaccine

If the risk assessment indicates that vaccination is suitable, then send the risk assessment to the prefect/equivalent, how in turn books vaccination according to the institutions routines.

The employer pays for the vaccination, not the employee.

In case of an accident, it is important to have a written routine, which dictates what to do in different situations; e.g. how to handle contact with blood or infectious agents. If you suspect a laboratory related infection, contact your supervisor and if needed the hospitals infection ward 018-611 56 08. Furthermore, the employer is required to document when exposure to infectious substances in risk class 3 or 4 has been ascertained in connection to incidents, accidents or other undesirable events. See infection risk regulation AFS2023:10, 11 kap, 8§ for details.

Information on what to do in case of contact with blood pdf, 5 MB.

Animal by-products¹ (often abbreviated ABP) are materials of animal origin that are not food and that have not yet been processed or treated in a way that would classify them as derived products. In research activities, this includes, for example, proteins, certain antibodies², cell cultures, blood, plasma, and serum of animal origin. It also includes other tissues as well as whole or parts of dead animals. It does not include living animals.

Several authorities are responsible for ensuring that those handling animal by-products and derived products comply with Swedish and EU legislation. The use of animal by-products in research requires a permit from the Swedish Board of Agriculture (Jordbruksverket). The purpose includes preventing the spread of disease and ensuring traceability, which entails requirements for record-keeping.

Uppsala University holds a permit from the Swedish Board of Agriculture for the import and use of animal by-products for research and teaching. To make use of this permit, complete form3 below and email them to the biosafety coordinator before each import. The user will then receive a time-limited copy and the permit number, which suppliers may require before dispatching the order. Please note, however, that the user and the head of department remain responsible for ensuring that transport, operations, and waste management are carried out in accordance with applicable legislation. Furthermore, by means of this application, the user and the head of department assume “operational responsibility” (“driftsansvar”) as defined in EU Regulation 142/2011.

A number of conditions are associated with the permit and must be complied with by the user, for example:

• The carrier must be approved to transport animal by-products.
• A requirement to keep records in accordance with Section 1, Chapter 1 of Annex VI to Regulation (EU) No 142/2011, including material covered by Chapter 3, Section 1 of the Swedish Board of Agriculture’s regulations (SJVFS 2026:2). The records must be well compiled and easily presented to the competent authority (the Swedish Board of Agriculture) upon inspection.
• A requirement that the material be transferred directly to the permit holder’s facility.
• A prohibition against the product coming into contact with animals, other than those specified in the permit.
• A prohibition against any subsequent use of the products for purposes other than those stated in the application.
• An obligation to:
  • handle the material in a manner that is safe from an infection control perspective and in accordance with good laboratory practice;
  • after use, dispose of the products safely or return them to the place of origin.
• For all types of import, an original commercial document³ issued by the sender must accompany the transport. The purpose of the commercial document is, among other things, to ensure traceability and to provide you as the recipient with certification of the contents of the consignment. Commercial documents and copies must be retained for two years. This applies to both national and international transports. A copy of the commercial document must be emailed to henrik.gradstedt@uu.se.

¹ Regulated by Regulation (EC) No 1069/2009 and the Swedish Board of Agriculture's regulation SJVFS 2011:21.
² Affinity-purified antibodies are not considered animal by-products.
³ Form for requesting a copy of the general permit for import and use of certain biological samples for research and teaching from the Swedish Board of Agriculture. docx, 23 kB.

To support institutions working with materials that may pose a biological hazard, Uppsala University has established the University’s Biorisk Committee in accordance with a decision by the Vice-Chancellor (UFV 2018/2180). The Committee consists of experts from relevant fields of expertise. Researchers, research group leaders, biosafety officers, and heads of department are encouraged to contact the Biorisk Committee with questions relating to biological risks, such as the handling of infectious agents, genetically modified organisms, invasive species, and matters concerning regulatory or definitional boundaries.

Members of the Biorisk Committee:

• Magnus Essand, Professor at the Department of Immunology, Genetics and Pathology
• Henrik Gradstedt (secretary, contact-person), Biosafety coordinator at the Buildings Division
• Joakim Holmdahl, Centrumchef CFVUU
• Josef Järhult, Professor at the Department of Medical Sciences
• Peter Lindblad, Professor vid institutionen för kemi - Ångström
• Anna Maria Näslund, Arbetsmiljöingenjör vid enheten för miljö och fysisk arbetsmiljö
• Joëlle Rüegg, Professor at the Department of Organismal Biology
  
• Stefan Schwartz, Professor at the Department of Medical Biochemistry and Microbiology
• Mikael Sellin, Docent at the Department of Medical Biochemistry and Microbiology
• Staffan Svärd (Chairman), Professor at the Department of Cell and Molecular Biology
  

Riktlinje för bioriskkommittén vid Uppsala universitet 2018pdf, 32 kB.

Beslut om Bioriskkommitte och ledamöter 20250218

At departments/equivalents that handle materials that may pose a biological hazard (e.g. infectious agents and genetically modified organisms), the head of department/equivalent shall appoint at least one biosafety officer.

The overall purpose of the biosafety officer role is to support the head of department/equivalent in the department's/equivalent's work with materials that may pose a biological hazard. The role of biosafety officer generally corresponds to what is aslo internationally known as a Biosafety Officer (BSO), however, the overall responsibility for work with materials that may pose a biological hazard still lies with the head of department/equivalent.

Rector's decision on the introduction of a biosafety officer pdf, 912 kB.

Job description biosafety officer docx, 64 kB.

Delegation from the head of department/equivalent to the biosafety officer docx, 81 kB.

Inform henrik.gradstedt@uu.se when you have appointed a new Biosafety Officer.