Part 1 of the form shall be used to notify an L-activity including one or more GMM-uses to the Swedish Work Environment Authority, while part 2 should be used for investigations and assessments of the risks, which have to be done for all contained use of genetically modified microorganisms. Only part one shall be sent in, whereas, part two must be available for all personnel involved and presented for The Swedish Work Environment Authority in case of inspection. Start with points 10 and 11 of part 1 and then proceed with part 2!
PART 2
Investigation, assessment and classification.
This part of the form follows the procedures of Appendix 1 in the provisions AFS 2011:2 and is meant to be used for investigation, assessment and classification of GMM-uses within an L-activity. The procedures shall be followed for investigation and assessment according to 3 §, determination of safety level according to 5 §, as well as classification according to 7 §, in AFS 2011:2. The numbering is the same as in Appendix 1 B of AFS 2011:2.
If filled out correctly, this part of the form will constitute the documentation required according to 4 § in AFS 2011:2. Therefore, filled out forms must be kept within the premises of the activity, be easily accessed by all personnel involved and presented for The Swedish Work Environment Authority in case of inspection.
Use one form for each GMM-use. If you have more than one GMM-use, copy the part delimited by dotted lines in the beginning and the end of Part 2, and paste it in at the end of the form. Please, number the GMM-uses and write the respective number above the line in "GMM-use_". Give also a unique designation to the GMM-use, which is not more than 50 characters in length.
1. Identified potentially harmful effects associated with the GMM.
The potentially harmful effects are those that may occur in case no safety measures are taken.
For the GMM, the recipient organism, vector, and inserted genetic material (and donor organism if it is part of the GMM-use) you must indicate which potentially harmful effect(s) that may occur as a result of the GMM-use. The harmful effects correspond to those listed in Appendix 1 A of AFS 2011:2.
A short description of the GMM as well as information about recipient organism, vector, and inserted genetic material shall be given under point 10 and 11 in the first part of the form, so you do not have to write that here.
2. Assessment of the identified potentially harmful effects.
Assess how serious each individual potentially harmful effect is, if you have identified any for the GMM/recipient organism, vector or inserted genetic material. Also assess how likely it is that such a harmful effect will occur if no safety measures are taken.
The gradation "negligible - low - moderate - high" is comparable with the definitions F-activity, L-activity, and R-activity of 2 § in the Ordinance on Contained Use of Genetically Modified Organisms (SFS 2000:271).
3. Identification of factors in the specific GMM-use that can increase the probability for the potentially harmful effects to occur or for dissemination of GMM into the environment.
According to Swedish legislation, GMM cannot be released into the environment without a special permit (deliberate release, see chapter 13 in The Swedish Environmental Code).
Investigate and assess if the specific use of GMM could increase the probability for a potentially harmful effect to occur, or for release of GMM into the environment.
Investigate if the environment into which the GMM might be released contains particularly sensitive organisms that might be harmed by the GMM.
Some ways of handling GMM can increase the probability of e.g. formation of aerosols or of personal injury. It is important that you identify any such steps when you are assessing what safety measures are needed.
4. Assessment of which safety measures are required and will be applied.
When you have identified what potentially harmful effects that may be associated with GMM, you shall assess what safety measures are required to prevent adverse effects on human health and the environment.
Check also Appendix 2 A and tables in Appendix 2 B of AFS 2011:2. Safety measures in the tables that are used within the premises but are not necessary shall not be considered since it is only those safety measures that are required that determine the safety level.
If safety measures of the type "dependent on the result from the investigation according to 3 §" are required, then the corresponding safety measures must be ticked in part one of the form ("9. Information about GMM uses/Safety measures for individual GMM-uses").
You may delete tables which are not applicable for your GMM-use.
5-7. Comparison of the safety measures required with those in tables of Appendix 2 in AFS 2011:2, classification, and confirmation that the safety level is sufficient.
Compare the safety measures you have found being necessary with those in the table of Appendix 2 B of AFS 2011:2 that matches the focus of the L-activity (e.g. laboratory activity, large-scale activity etc.).
The safety measures in the respective table in Appendix 2 B are adapted for different types of frequent work with GMM. The focus of the L-activity to which your GMM-use belongs should fit into one of the categories.
Each table in Appendix 2 B contains five columns of which the one to the left lists the safety measures whereas the other four have been used to mark if the respective safety measure is required, is not required, or may be required dependent on the result from the investigation of the risks, for the four different safety levels of which level one is the lowest and level four the highest.
Mark the table or combination of tables that contains the required safety measures.
In the form, you shall only select one alternative. If you have for example both laboratory and animal activities, then you must use two different forms.
During certain circumstances no table is applicable. Then you must contact the Swedish Work Environment Authority to get advice on how to proceed.
Sufficient safety level and classification.
Compare the set of safety measures you have found necessary with those that are required for the L-activity (see the relevant table of Appendix 2 B of AFS 2011:2).
If safety level 2 is sufficient to contain the GMM and to prevent adverse effects on human health and the environment, then your GMM-use(s) can belong to an L-activity.
If safety measures from another table of from a higher safety level are required for one or more of the GMM-uses, then these uses must be part of another L-activity or even belong to a higher safety level of an R-activity.
PART 1
Notification of an L-activity.
Own designation of the L-activity
Give your own identifying designation of the L-activity, which can be used to differentiate it from other L-activities. Should not exceed 50 characters.
1. User (Verksamhetsutövare).
The user is Umeå University. The Swedish identity no. (Organisationsnummer) for Umeå University is 202100-2874.
2. Biosafety committee or other advisory function, if present.
Umeå University has no Biosafety committee. The advisory function at Umeå University is the Biosafety Officer.
3. The premises in which GMM will be used.
Address of the premises.
Give the visiting address for the building containing the premises.
Indicate names or numbers of buildings of the premises.
The defined area.
Give room numbers and attach a drawing or sketch of the premises. Do not include offices, lunch rooms, storage rooms or other "clean" areas.
Indicate which rooms are specific for the L-activity and which, if any, are shared with other GMM-activities. If there is within the same organisation more than one L-activity with the same focus using the same premises it is important to investigate how the different responsibilities are divided up.
Overview of premises.
Indicate in the table what type of rooms are used within the L-activity.
4. Part of organisation and responsibilities.
a) The organisational unit can be a department, section, sub-department etc. It is convenient if the organisational unit is the same as that responsible for the work environment in the premises.
b) The person who has been assigned the overall management responsibility according to the Swedish legislation on the environment and work environment is usually the head of a department etc.
c)-d) Persons with assigned duties regarding management and/or safety.
Parts of the management responsibility and duties with regard to management and safety according to the work environment legislation can be further delegated. Indicate who has been assigned the overall management responsibility and/or duties regarding safety issues for the GMM activity that is being notified.
If the person who has been assigned overall duties with respect to management and safety of the L-activity is the same as under b), one still has to give the requested information here. Indicate what the assigned duties are and also give the education and qualifications of that person for the assigned duties. Note that point c) refers only to management an safety duties within the GMM-activity.
If duties with regard to management and safety have been given to more than one person, then information must be given at d) also.
Assigned duties.
Give duties that have been assigned according to the legislation on work environment (see for example the provisions, AFS 2001:1, on Systematic Work Environment Management) and on the environment (see for example the Ordinance 1998:901, on Operators' Self Monitoring). The distribution of the duties has to be known within the L-activity.
e) Persons responsible for individual GMM-uses.
Fill out one copy of the table for each person in charge. Copy this section so there is one for each person.
At "GMM-use/uses", the name of the GMM-use(s) shall be given. If only one person is responsible for all uses, you can write "All uses".
Check that you have listed all GMM-uses for each person in charge.
At "Assigned duties with respect to supervision and/or safety to comply with the Swedish legislation on the environment and work environment (give also position)" you should write what duties the person has been assigned (by the chairman).
5. Description of the L-activity.
Focus of L-activity.
Mark only one focus. The respective focus and tables with associated safety measures are: Laboratory activity, Table 1a; GMM in animal activity, Table 1a and b; GMM in plant activity, Table 1a and c); Large-scale activity, Table 2. If you have to mark more than one focus, you have more than one L-activity. Use a separate form for each L-activity.
GMM in Laboratory activity.
Genetically modified cells cultures of higher organisms are also considered to be GMMs.
GMM in Animal or Plant activity.
You can only notify contained use of genetically modified microorganisms to the Swedish Work Environment Authority. Genetically modified cells that are transplanted to or inoculated into other organisms are also considered as GMM. On the other hand, contained use of genetically modified animals or plants, such as mice, is supervised by the Swedish Board of Agriculture whereas contained use of genetically modified aquatic organisms, such as zebrafish, is handled by the Swedish Agency for Marine and Water Management. Therefore, if you will have contained use of GMM in genetically modified animals or plants, you must also contact the Swedish Board of Agriculture or the Swedish Agency for Marine and Water Management if you have not already done so.
Indicate which type of animal or plant that will be used, e.g. rat, mouse or mouse-ear cress (arabidopsis).
Type of L-activity.
You may mark more than one alternative.
Education.
Mark this alternative only if teaching is of undergraduate students. Supervision of Ph. D. students during their daily work is not considered as education in this context.
Approximate volume of GMM used at any one time in one container.
You should only tick one of the boxes for volume ranges. This is to give an idea of the extent of the L-activity. A large-scale operation does not necessarily mean several hundred litres of cultivation volume. What determines the focus of the L-activity is which of the tables in Appendix 2 B of AFS 2011:2 that is needed.
6. Description of handling of waste.
Rules for contained use of GMM are also applicable for destruction and disposal of GMM. To prevent unintentional dissemination of GMM into the environment it is important to consider how the GMM is handled when it becomes waste.
Description on how the GMM is made harmless before discarded as waste.
Chemical treatment.
If chemical agents are used, indicate which and how.
Hazardous waste.
If the GMM has been made harmless before discarded, the waste can be treated as ordinary waste, if not containing other hazardous items.
Receiver of hazardous waste that contains GMM that have not been made harmless.
Give the name of the receiver of the waste that contains GMM that have not been made harmless. Leave blank if GMM are inactivated within the premises.
7. Safety measures; Table in Appendix 2 of AFS 2011:2 that is applied.
Mark the table that is appropriate for your GMM-activity. If you have to mark more than one alternative, then you probably have more than one L-activity. You have to fill out one form for each L-activity.
8. Written handling and safety instructions.
Provide the instructions as attachments. It is the instructions that the personnel should follow that must be provided.
Some handling and safety instructions are suitable for all GMM-uses. Keep in mind that they should be compatible with those for other L-activities sharing the same work space.
If individual instructions apply to just one or a few GMM-uses, you must specify which instruction belongs to which use.
Information on the GMM-uses of the L-activity.
9. Overview of the GMM-uses.
The numbering to the left (1, 2, 3) indicates that you should give information for each use separately. Use the same names as you have used in part 2 of the form. If necessary, add more rows by placing the cursor to the right of the last row and then press return.
Allocation within the premises.
Indicate which rooms that will be used for each separate GMM-use. If all rooms of the L-activity will be used you can write that instead of the designations of all rooms.
Safety measures for individual GMM-uses.
This table summarizes the results from the investigation, risk assessment and classification you have done when answering the questions in part 2 of this form.
We expect you to apply all compulsory safety measures listed in Table 1a in Part 2 of the form. If only these are needed, then you must only tick the box for the respective GMM-use under: "Only the compulsory are needed". If also other safety measures listed in Part 2 are required, then instead mark those that will apply from Table 1 a (b/c) and Table 2 under: "Safety measures needed according to the investigation at 3 §". For example, if the GMM is airborne and has to be handled in a microbiological safety cabinet, then tick the box for that.
10. Description of the GMM-use and, 11. Details about the biological material
Sections 10 and 11 have been combined in the form.
There are different variants of this section of the form. Choose what is appropriate for the current use. If you are reporting multiple GMM-uses, you may need to use different variants of the section. Note that you can only notify GMM-uses of the L-activity you are notifying in this form.
Which variant should I use?
If you are planning to use virus vectors in cell cultures you should fill out variant a). This applies both if you will use established cell lines or primary cells. Regardless of if you are producing virus vectors or using ready-made virus vectors in the cells, you can use this variant. If you want, you can use one form for the production of the vectors and one for the actual use of them (i.e. two individual GMM-uses), but it is not necessary, you can instead notify one GMM-use which includes both the production of the vectors and the use of them.
If you are planning to use virus vectors or genetically modified cells on animals you should use variant b). Normally, it is not possible that such a use also includes the production of vectors, as this is usually done in a different location (and different L-activity) than the actual work on the animals.
If you are planning to use genetically modified viruses in cells or animals you should use variant c). If your viruses will function as vectors it is probably more appropriate to use variants a) or b), but if you use both vectors and viruses, form c) may be most appropriate.
If you are planning to use other GMMs than viruses, virus vectors, or cells, then you should use variant d). It can be used for GMMs in laboratories, in animal or plant experiments. Common GMMs for which variant d) is suitable are bacteria and fungi.
What information should be provided?
For each of the GMM-uses, you need to describe briefly why and how the specific GMM will be used, and what the expected result of the genetic modification will be. Please, describe what the greater purpose is of the experiment, for example what your research aims are in general. This information will be part of our description of your GMM-use.
Keep in mind that the recipient organism in this context is the same as the GMM before genetic modification, whether YOU will genetically modify it or have received it from someone else. Animals or plants are not recipient organisms in this context, even though the GMM is used to influence individual characteristics of an organism.
Since you must be able to clearly describe traits and identity, you can normally have only one species / strain / subspecies in each GMM-use. This applies not the least to virus vectors. If you indicate "retroviral vectors" without giving more details, you will receive a request for completion from us. In a cell-vector system, on the other hand, you can normally use different kinds of cells, if you specify if they are primary cells, established cell lines, induced pluripotent stem cells (iPSC) and what kind of organism they come from. If the characteristics of the cells are of significance for the risk, you probably have to describe them in a separate GMM-use.
If you have a virus vector, you need to specify whether it is replication incompetent, conditionally replication-competent or fully replication-competent, either with or without inserted genetic material. If you are planning to use conditionally replication-competent vectors, describe how they can be activated.
You should always specify the intended function of the genetic material, such as "fluorescence marker", "increases the expression of X". Even if the genetic modification cannot mediate any harmful effects, the expected function shall be presented. Examples of inserts that might have harmful effects are those that express virulence factors, biologically active substances, toxins, or known oncogenes, or those that mediate receptor binding abilities or up- or down regulation of essential genes. Also specify marker genes included in the vector even if not used. Generalized terms such as "functional genes", "gene of interest" and "for example enzymes" are not precise enough to define a GMM-use. You probably do not need to specify every gene and construct, but still clearly describe what will be altered.
If you believe that your constructions need privacy protection, specify when you send in your notification which section of the legislation you invoke.
Tip! An L-activity can have as many GMM-uses as possible. Rather, divide a complex GMM-use into multiple, rather than trying to describe all applications with a single vector or GMM in a single GMM-use. Your notification is likely to be processed much faster if the uses are so clearly described that we do not need to request additional information.
12. Summary of the investigation and assessment decreed by 3 §.
The user (employer) has the responsibility to see to that all GMM-uses are documented and that the L-activity only contains GMM-uses for which safety level 2 are sufficient.
Investigation and evaluations have been done for all GMM-uses within the L-activity.
Tick the box to the right if this statement is correct.
Safety level 2 is sufficient and will always be used in accordance with point 3 above.
Tick the box to the right if this is correct.
Summarize the potentially harmful effects you have found during the investigation documented in part 2 of the form by ticking the boxes in the table under "Identified potentially harmful effects". Use one line for each use. If you have identified harmful effects on humans, tick the box under humans, and so on.