Biosafety

Information about infectious agents, genetic modifications, containment measures, risk assessments, permits and legal requirements

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.

When working with infectious agents and genetically modified microorganisms (GMM) there legal requirements in the provisions ”smittrisk” and "Innesluten användning av genetiskt modifierade mikroorganismer", which specify the containment measures required for work with infectious agents and GMM in different risk classes. For example, when gloves and lab coat is required and when the sign ”Biological Hazard” must be placed on the door to the lab.

Warningsign for Biological Hazard docx, 358 kB.

Apart from these general safety instructions, it is important that all those who participate in the work preform a risk assessment so that all the individual risks which may occur during the project can be identified, and safety measures implemented. The risk assessment should be kept in the laboratory, readily available to everyone, including government agencies during inspections. Some government agencies include a risk assessment form in the report form, if not here is a general risk assessment form for biorisks.

General risk assessment form docx, 679 kB.

Risk assessment flowchart. Start with a cursory description of the work, identify individual risks, assess, if needed modify the safety features to lower the risks.

Risk assessment flowchart. Start with a cursory description of the work, identify individual risks, assess, if needed modify the safety features to lower the risks.

A part of the risk assessment is to write instructions for handling an infections spill. Download these general instructions, adapt them to the risks in your laboratory, print them, and keep them in the groups’ spill-kit together with personal protective equipment and warning sign for biological spill.

Genneral instructions for a spill-kit docx, 15 kB.

Barricade sign docx, 122 kB.

Information about general risk management in laboratory work

According the provisions governing work with infectious agents (Smittrisk AFS 2018:4), human samples should in general be handled at containment level-2. For human samples with higher risk, e.g. COVID-19 patient samples, it could be prudent with additional containment measures. Propagation of SARS-CoV-2 samples should be handled at containment level-3. Se information from The Public Health Agency of Sweden for details.

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 AFS2018:4, § 11 for details.

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

 

Work with human infectious substances and genetically modified microorganism is primarily regulated by Arbetsmiljöverket (Swedish Work Environment Authority), and should be reported/permit applied for before the work starts. Work with other Genetically Modified Organisms (ex. plants and animals) is regulated by other agencies, see link to "Gentekniknämnden" to the right. If there still are any questions about GMO then contact the university's biosafety coordinator.

Link list - Provisions and information from the Genetic Enginering Board

Consult the biosafety coordinator with a copy of the report and risk assessment prior to sending it to Arbetsmiljöverket.

Send minor updates and changes in current GMM reports via the prefect to the biosafety coordinator during April each year. What constitute minor updates and changes is defined at page 28-31 in AFS 2011:2

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.

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.

A number of conditions are associated with the permit and must be adhered to be the user, such as:

  • The transporter must be approved to transport animal by-products.
  • There is a requirement to keep records in accordance with Section 1, Chapter 1 of Annex VI of Regulation (EU) No 142/2011, including for materials covered by Chapter 3, §1 of the Swedish Board of Agriculture’s regulations (SJVFS 2006:84). These records must be well-organized and readily available for inspection by the competent authority (Swedish Board of Agriculture).
  • The material must be delivered directly to the permit holder's facility.
  • The products must not be used for any purposes other than those stated in the application.
  • The permit holder is obliged to safely dispose of the products or return them to the place of origin, if applicable, and ensure that the product does not come into contact with animals other than those specified in the permit.
  • For all types of import, an original trade document3 issued by the sender must accompany the transport. The purpose of the trade document is, among other things, to ensure traceability and provide the recipient with certification of the shipment's contents. Trade documents and copies must be kept for two years. This applies to both national and international transports. A copy of the trade document should be mailed 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, 25 kB.

The Uppsala biorisk committee establishes general guidelines for work with biological risks. The chairman of the biorisk committee is Professor Staffan Svärd, and the biosafety coordinator acts as secretary and contact-person to whom researchers can come with all questions concerning biorisk, e.g. handling of infectious substances, Genetically Modified Microorganisms, Invasive species, and contact with government agencies, etc.

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.

Bilder från biosäkerhetskurs

For those who do not have the experience or are not acquainted with the Swedish laws and regulations governing work with infectious substances or GMM, the course “Working with Biorisks: Infectious Substances and Genetically Modified Microorganisms” is held several times each semester, 09:00-16:45 at BMC C6:109a

The course is free of charge for those who work at Uppsala University (2.000:- for external participants), and is primarily aimed at bachelor/master students, Ph.D. students, post-docs, laboratory assistants, and new group leaders. During the course we discuss the organization of Uppsala University, Swedish laws and ordinances, work with infectious substances, waste management, incidents and accidents, practical risk assessments, containment and clean-up of a simulated biological spill, how to handle sharps, and biosecurity. The course is held in English, and comes with complementary “fika” and lunch.

For Uppsala University Ph.D. students the course can often yield ”Ph.D. points”, ask your course administrator if this is the case at your institution. The course is not aimed at students in basic education as it does not yield credits ”högskolepoäng”

Sign-up closes the day before the course date, or when fully booked.

If this course date is under-booked (minimum 3 participants, maximum 7) it will be cancelled and you will be offered another date.

If none of the available dates work then it is sometimes possible for you to gather 3-7 participants and book a separate course date by mailing henrik.gradstedt@uu.se

Follow this link to the course dates.

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