Part 1 of the form shall be used to notify an F-activity 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 1 shall be sent in, whereas, part 2 must be available for all personnel involved and presented for The Swedish Work Environment Authority in case of inspection. Start with part 2!
Please, send in the Swedish version of part 1, however, you can write in English.
PART 2
Investigation, assessment and classification.
For some GMM-uses it is obvious that they should be part of an F-activity, however, they must still be investigated an assessed according to Appendix 1 B in the provisions AFS 2011:2. For such uses, a simplified procedure can be followed by filling out points 1-3 A, 4, and 5-7, of part two of the form. The numbering corresponds to that in Appendix 1 B of AFS 2011:2.
If all answers are "NO" in the table at 1-3 A for all GMM-uses, you do not have to fill in the information requested at 1-3 B, and can proceed directly to point 4.
If one or more of the uses must be investigated more thoroughly, list only those uses that do not require further investigations, at the bottom of the table at 1-3 A. For uses that require additional investigations, proceed with points 1-3 B.
1-3 A: Identification of GMM that can be used at safety level 1 in accordance with the criteria in Appendix 1 C and identification of other factors that may affect the probability of harmful effects or dissemination of GMM into the environment.
GMM that fulfil the criteria in Appendix 1 C of AFS 2011:2 can normally be used within an F-activity. For clarification, these criteria have been translated into questions 1.a-e. If these criteria are fulfilled, you can skip step 2 in the procedure that is described in Appendix 1 B of AFS 2011:2, and proceed with step 3, corresponding to questions 3.f-h.
1. Potentially harmful traits associated with the GMM.
Go through the table for each and every of the GMM that will be used. If the answer is NO on all questions for a particular GMM, then the criteria in Appendix 1 C are fulfilled for that GMM. Then, one has to check if there are other factors in the use that may increase the probability of harmful effects (see next point).
3. Factors that increase the probability of harmful effects or of dissemination into the environment.
Go through the table for each and every of the GMM that fulfilled the criteria in point 1. If the answer is NO also on these questions, then proceed directly to point 4 to assess what safety measures are required.
List on the GMM of the F-activity that fulfil all criteria in Appendix 1 C and for which no factors increase the probability of harmful effects or of dissemination into the environment.
List all GMM that fulfil the criteria in Appendix 1 C and are part of the GMM-uses for which there are no factors that increase the probability of harmful effects or of dissemination into the environment. Indicate also who is managing individual uses if more than one user has GMM-uses.
If the list with all the GMM that fulfil the criteria will be long, one can have it as a separate document.
List created by, updated by, and date.
The documentation of the investigation and assessment shall be kept within the F-activity either in a digital format or as a printed copy. If new uses are started, then the list shall be updated by adding the new uses to it, if they fulfil all criteria. It is reasonable, that the name of the person who created or updated the list is recorded.
For the GMM you listed at 1-3 A, you can go directly to point 4. For GMM that require further investigation, proceed with 1-3 B.
1-3 B: Investigation and assessment of potentially harmful effects and probability of dissemination into the environment.
If you have more than one GMM-use that has to be investigated further, make a copy of the part of the form that is between the dotted lines, for each use.
Fill out the general information on the GMM-use:
GMM/recipient organism.
The recipient organism is the "GMM" before the modification (see definitions in 2 § of AFS 2011:2).
The identity and traits of the recipient must be described unambiguously, which normally means that only one species can be described in each GMM-use. However, different strains within e.g. the species E. coli can be so different that they must be part of different uses or even belong to different risk groups and therefore cannot be part of even the same activity.
The description can be general, however, it must be made clear what has been changed genetically and that the potentially harmful effects listed in Appendix 1 A of AFS 2011:2 have been considered.
Indicate if the GMM and the recipient will belong to different risk groups. List only traits that are relevant for the risk assessment.
Vector/corresponding.
A vector can originate from a naturally occurring plasmid, bacteriophage or another virus.
State which vector you are using. If no vector is used, describe in what way the genetic material is transferred to the recipient.
Risk group/ corresponding.
You can evaluate which risk group a human pathogen belongs to by checking the criteria in Appendix 2 A in the provisions from The Swedish Work Environment Authority about Microbiological Work Environment Risks – Infection, Toxigenic Effect, Hypersensitivity (AFS 2005:1).
In Sweden, there is no list of microorganisms pathogenic to plant and animals, but the criteria for human pathogens may be used for plant and animal pathogens.
If a vector with human origin is used, indicate if it is replication deficient or not. Only when the vector is not in a form that will allow entry into the cells of the employees can it be used at safety level 1, provided that no other harmful effects can occur.
Inserted genetic material.
GMM to be used within an F-activity shall not have received any traits that can cause potentially harmful effects through the genetic modification. Be careful to go through what is inserted and what may 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 giving a broader host range, or up- or down regulation of essential genes.
Describe the intended function in GMM.
Give the intended function of the inserted genetic material even if the the genetic modification cannot lead to any harmful effects.
The origin of the genetic material/donor organism.
Give information on the source of the inserted genetic material including information on the organism(s) from which it originates.
The donor organism is part of the use.
If the donor organism is e.g. a pathogenic bacterium and is used within the GMM-use to be notified, it can be a reason for the GMM-use to belong to a GMM-activity of a higher safety level even if the resulting GMM requires fewer safety measures than the donor organism.
1. Identification of 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.
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.
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.
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 F-activity (e.g. laboratory activity, large-scale activity etc.).
If safety measures in the table of Appendix B of AFS 2011:2 are required for a GMM-use but are not found in the form then that GMM-use cannot be part of an F-activity.
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 F-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 F-activity (see the relevant table of Appendix 2 B of AFS 2011:2).
If safety level 1 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 F-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 F-activity or belong to an L-activity.
PART 1
Notification of an F-activity.
Give your own identifying designation of the F-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.
It is not always necessary to have a Biosafety committee, different solutions are applicable in different organisations.
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.
For an F-activity, it is sufficient to indicate which rooms that are part of the premises. Preferably, you can attach a drawing or sketch of the premises to the notification. Do not include offices, lunch rooms, storage rooms or other "clean" areas.
Do not indicate entire floors if other GMM-activities are present, specify instead which rooms are part of the premises for the F-activity and indicate also if some rooms are shared with other GMM-activities.
Overview of premises.
Indicate in the table what type of rooms are used within the F-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 F-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.
Note that one shall not list research group or project leaders who have been assigned duties with respect to management and safety of individual GMM-uses within their own work. However, such information must be kept within the premises.
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 on Operators' Self Monitoring). The distribution of the duties has to be known within the F-activity.
5. Description of the F-activity.
Focus of F-activity.
Mark only one focus. The respective focus corresponds to a table or a combination of tables in Appendix 2 B of AFS 2011:2 in which the safety measures are listed: 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 F-activity. Use a separate form for each F-activity.
GMM in Laboratory activity.
Genetically modified cells cultures of higher organisms are also considered to be GMM.
GMM in Animal or Plant activity.
You cannot notify contained use of genetically modified animals or plants (GMO) to The Swedish Work Environment Authority. It is only contained use of GMM that is referred to in this section. The animals and plants of the Animal and Plant activities, respectively, can be either genetically modified or unmodified. If they are genetically modified, you have a contained use of animals or plants.
Indicate which type of animal or plant that will be used, e.g. rat, mouse or mouse-ear cress (arabidopsis).
Type of F-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.
Type of GMM used within the F-activity.
Mark in the form which group or groups of organism the GMM belong to. You do not have to describe the GMM in more detail when notifying an F-activity, however, the investigation and assessment of the risks of the GMM-uses according to Appendix 1 of AFS 2011:2 must always be done.
If you would like to work with GMM that are human pathogens within the GMM-activity, you most likely have to notify an L-activity. If you are planning to use virus vectors based on virus that are pathogenic to humans, when for example working with cell lines, then that GMM-use should be part of an L-activity (at least). This is the case at least when there are virus particles which would be able to infect (but not spread within) humans, i.e. even replication deficient virus vectors, however it also depends on the type of vector, in which form it is, as well as what kind of insert that is present in the vector.
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.
7. Summary of the investigation and assessment according to 3 § and information on which table containing safety measures is applied.
The user (employer) has the responsibility to see to that all GMM-uses are documented and that the F-activity only contains GMM-uses for which safety level 1 are sufficient.
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.