Registration, permits and risk assessment for GMM

The definition of a genetically modified microorganism (GMM) is a microorganism whose genetic material has been altered in a manner that does not occur naturally through mating or natural recombination (SFS 2000: 271)

All "verksamheter" (activities) with GMM must be assessed and notified to- or get permission from the Work Environment Authority. This is done by KI's Biosafety Coordinator and in consultation with the Institute's Biosafety delegates.

For GMMs that may present a risk, each use must also be reported to the Work Environment Authority.

On the Swedish Work Environment Authority site you will find information about GMM as well as the regulation "Contained Use of Genetically modified Microorganisms" (AFS 2011:2Eng), provisions. Below is a brief description of different concepts that may be good to know before submitting a GMM notification.

Verksamhet (activity) and use

"Verksamhet" is an administrative term, which is limited by:

  • A responsible person
  • An address
  • A level of protection
  • A type of verksamhet, e.g., laboratory, teaching or animal experiments

Experiments that are to be implemented in the laboratory as well as in the animal facility shall therefore belong to two different verksamheter. These must have separate risk assessments and reported separately.

For a GMM-verksamhet, one or more GMM-uses may be included (the attempts performed in the verksamhet).

Use is similar to the same type of experiment. GMM uses are separated from each other by the vectors, genes, recipient organisms and GMM that are included in the use and how GMM is used. Several GMMs can not normally be included in one and the same GMM usage, however, several constructs with the same GMM, same vector, and similar insert can be accommodated within the same GMM usage.

It is the use that is risk assessed and as long as the use can be covered by a well-conducted risk assessment, several similar experiments can be included.

Classification of GMM, notification and permits for these

The handling of GMM is divided into three different Veksamhet-levels: F (negligible risk), L (low risk) and R (risky activity) depending on risk assessment.

GMM, Level F

A genetically modified microorganism or cell culture where the microorganism does not normally cause infection, or where the cell culture contains no human pathogens and where vectors and inserts can not cause human damage. Handled in security level 1.

Although the GMMs you are using do not involve risks to human health or the environment, they must be kept indelible. This means that they can not be taken out of the facility via sewage or waste.

If you are going to work with GMM at Level F, you need to make sure that the rooms you work in are part of an approved F verksamhet. Contact your biosecurity representative if you are unsure. For level F, each research group assesses its different uses on the second part of the Swedish Work Environment Authority's form for reporting F-verksamhet. (the part called "investigation, assessment, classification").

The risk assessment is simple and comprehensive and you can risk assess many of the GMM uses in the same form. The important thing here is to ensure that GMM does not get into the sewage or household waste and that the risk is really negligible, that is to say. level F.

The risk assessment is kept nearby the laboratory and does not need to be sent to the Work Environment Authority.

GMM, Level L

A genetically modified microorganism in which either microorganisms belong to risk class 2 or where the vector can infect or enter human cells and deliver the genetic material (regardless of the ability to replicate), or where expression of genes can give rise to allergic or toxic effects. Requires management at security level 2.

For level L, you must first notify each use and ensure that the room you are going to work in is included in an approved L -verksamhet. Contact your biosafety coordinator to consult if you need to report a new L-verksamhet or if there is an L-verksamhet you can work in.

On the Work Environment Authority website there are forms and more information about the registration of new L-verksamhet or notification of new use in existing L-verksamhet. (the application is under Document)

Experiments at this level of verksamhet should always be limited by handling instructions. These can either be verksamhets- or usage-specific. When reporting, it should be clearly stated what kind of handling instructions will be used.

GMM, Level R

Genetically modified microorganisms with moderate or high risk of human health or environmental damage. The handling requires protection levels 3 or 4. See the website of Work Environment Authority for more information on Level R and forms for the permit application.

Overview of the notification/permit procedure

Define the level of verksamhet (F, L, R) to which the experiment (such as the use) is to be performed. The level of activity is determined after the risk assessment.

Verify that there is an approved verksamhet that the experiment (such as the use) will belong to. The institute's Biosafety delegates at the department has information of approved verksamhet. See the list of contacts under Document

At the start of new verksamhet, one needs to define who is a manager with assigned tasks in safety and health. The head of a department is responsible for the activities and the working environment.

For a minor activity that is only used by one or a few groups, it is common to also specify a research group leader as responsible, as this provides better insight into the verksamhet itself.

It is then important to describe the division of responsibility, ie what the research group leader is responsible for. For example, there are routines and that the room has the protective equipment that you have specified in the notification to the Work Environment Authority, as well as to approve new users.

Risk assessment of GMM should always be done on the Work Environment Authority's forms. Risk assessments of verksamhetsexperiments level F do not need to be sent to the Work Environment Authority. Other risk assessments shall be sent to the biosecurity coordinator, who will provide comments and also submit the application to the Work Environment Authority.

It is also advisible, especially for some of the larger verksamheter used by several research groups, to have a coordinator for the laboratory (laboratories), who can introduce new employees to routines and ensure that equipment exists and functions, and that routines are followed. Here too, it is advisable to describe what tasks this person is responsible for.

Contact the Biosafety delegates at the institution and the Biosafety coordinator on new notification of the verksamhet.

Risk assessment and approved notification or permission must always be kept in connection with the verksamhet. The documentation must be displayed at the safety rounds and inspections by the Work Environment Authority.

For levels L and R, each use must be notified to- or obtain permission from the Work Environment Authority. For level L, a compilation of the risk assessment must be attached and for level R must the entire risk assessment be attached for the use.

Experiments with GMM may not start until the verksamhet or use is approved by the Work Environment Authority. At KI, all notifications are sent to the Biosafety coordinator for review. Thereafter, the Biosafety coordinator sends the documentation to the Work Environment Authority.

When experiments are planned and no longer are covered by an approved use, either a new usage notification must be made or an existing use should be updated. This also applies if the handling instructions change. Even in this type of change, the documentation must be sent to the biosafety coordinator who reviews and sends to the Work Environment authority.

It takes from a few days to a few months to get a notification approved by the Work Environment Authority. The approval will be sent by e-mail and will be called "Notification of received notification for new use in L-business". This documet should also be stored ner the experiments.



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