Part one of the form shall be used to notify one or more new GMM-uses in an already existing L-activity to the Swedish Work Environment Authority, while part two 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 part two!
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.
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. In case of more than one use, copy the part between the dotted line on page 1 and 4, and paste it in at the end of the form.
If you have more than one GMM-use, please number them 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 4 and 5 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.
For large-scale uses, you also have to assess if release of a large amount of GMM as such could affect a sensitive environment.
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 which 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 ("3. Information about GMM uses/Safety measures for individual GMM-uses").
You may delete the table that is 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 are 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 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
1. The Swedish Work Environment Authority's ID number for the L-activity .
The identity number of the L-activity was previously assigned by The Swedish Work Environment Authority (Arbetsmiljöverket). Starts with "202100-2874 v" and then a number.
2. 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".
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).
3. Information about GMM-uses.
Allocation within the premises.
For each individual use, list the parts, e.g. by giving room numbers, of the premises that will be used. Write the type of rooms being used, e.g. laboratory room number or incubator room room number. Append a drawing if possible. Extend the table if necessary.
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.
If only obligatory safety measures are needed, then you can tick the box for the respective GMM-use under: "Only the compulsory are needed". If you have come to the conclusion that also other safety measures are needed, 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 §".
Instructions adapted for individual GMM-uses, when necessary.
Here you can present instructions that are specific for one or more uses. You can write the names of more than one GMM-use on the same line if the same instructions/ attachment apply for them.
If there are differences compared to the rest of the L-activity.
"Treatment of waste (addition/change)". If there is an addition to existing routines, write that under "New information" and leave "Previous information" blank. If there is a change of previous information, write the update under "New information" and the old information under "Previous information".
If there is a change to the largest volume of liquid containing GMM in a single vessel, in the L-activity, then write that under "New approximate volume".
4. Description of the GMM-use and, 5. Details about the biological material
Sections 4 and 5 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 however, that you here cannot notify new GMM-uses in different L-activities.
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 virus 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 virus, 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?
It is important that you explain what you are going to investigate and by what means so that The Swedish Work Environment Authority can judge if the GMM-use is at the right safety level and that the selected safety measures are appropriate. 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 will be from the genetic modification. Please, describe what the greater purpose of the experiment is, 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.
"Inserted genetic material". Be careful to go through what is inserted and what can be expressed. 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. You should always specify the intended function of the genetic material, such as "fluorescence marker", "increases the expression of X". 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 are screening libraries or unknown sequences it could still be possible to suggest a function of for example a cloned gene/sequence.
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.
6. 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.