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GMM – anmälan 8.1-2
F Notification of F-activity
Version 2.3 Senast ändrad 28 januari 2015
Part one of this form shall be used to notify an F-activity in accordance with Appendix 3 of
the provisions on contained use of genetically modified microorganisms (AFS 2011:2). The
second part of the form is for documentation of the investigation and assessment of risks in
accordance with 4 § of AFS 2011:2.
Only part one of the form shall be sent in. A copy of the complete form is kept within the Factivity.
For more information, check the guide to this form.
A copy of part one of the form shall be sent to arbetsmiljoverket@av.se, please write "Anmälan av
GMM-verksamhet" on the subject line. Do not forget to attach appendices, if any. Instead of sending
the notification by E-mail you may send it as a printed copy to Arbetsmiljöverket, 112 79 Stockholm.
Basic information on the organisation and premises
Own designation of the F-activity
Contact person
Name
E-mail
Phone no.
(Mobile no.)
1. User (Verksamhetsutövaren)
Name
Swedish identity no. (Organisationsnummer)
Address
2. Biosafety committee or other advisory function, if present
Biosafety committee or other solution (name, position)
Short description of advice received
3. Premises in which GMM will be used
Location of premises (street address and city)
Building number/corresponding, if any
Defined area (Floor no., room no. etc.)
Drawing or sketch as appendix no.
Overview of premises
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GMM – anmälan 8.1-2
Laboratories
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Animal
facility/corresponding
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Greenhouse/growth room
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Walk-in cooler-/freezer/
incubator room
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Autoclave-/dishwashing
room
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Centrifuge-/equipment room
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Fermentors/corresponding
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Other (describe):
4. Part of organisation and responsibilities
a) Department or corresponding which is in charge of the F-activity
b) Information on person who has been assigned the overall management responsibility
at the organisational unit above
Name
Position
E-mail
Phone no.
(Mobile no.)
c) Information on person responsible for the management and/or safety of the F-activity
Name
E-mail
Phone no.
(Mobile no.)
Assigned duties with respect to management and/or safety to comply with the Swedish legislation
on the environment and work environment (give also position)
Education and other qualifications related to the assignment
d) Information on any other person responsible for management and/or safety
Name
E-mail
Phone no.
(Mobile no.)
Assigned duties with respect to management and/or safety to comply with the Swedish legislation
on the environment and work environment (give also position)
Education and other qualifications related to the assignment
Information on F-activity
5. Description of F-activity
Focus of F-activity (mark only one!)
Laboratory activity
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Large-scale activity
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GMM in animal activity*
Species:
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GMM in plant activity*
Species:
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Other activity (describe):
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GMM – anmälan 8.1-2
*) Note that contained use of genetically modified organisms (GMO) that are not GMM is managed by other
authorities. See www.gmo.nu for more information.
Specification of type of F-activity
Research and
development
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Education (upper
secondary school)
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Education (post upper
secondary school)
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Pilot experiments
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Production
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Diagnostics/Analysis
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Other (describe):
Type of GMM used within the F-activity
Bacteria (incl. archaea)
Protozoans
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Virus (not human pathogens)
Animal/human cells
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Fungi
Plant cells
Other (describe):
6. Description of handling of waste
Indicate what type of waste that contains GMM is produced
Solid waste
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Liquid waste
Other
(describe):
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Description on how GMM is made harmless before discarded as waste
Autoclaving or incineration within the
premises
Chemical treatment (describe how)
Other method (describe how)
Not made harmless; sent as hazardous waste
Recipient of hazardous waste that contains GMM which has not been made harmless
Name of recipient
Description on how the recipient is informed about the GMM in the waste
7. Summary of the investigation and assessment according to 3 § and information on which
Table containing safety measures is applied
Investigation and assessment have been done for all GMM-uses
(documentation is kept within the F-activity)
Safety level 1 is sufficient for all GMM-uses within the F-activity
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Table in Appendix 2 in AFS 2011:2 that is applied (mark only one of the options)
Table 1 a) (Laboratory activity)
Table 1 a) + b) (Animal activity)
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Table 1 a) + c) (Plant activity)
Table 2 (Large-scale activity)
None of the tables is applicable (other activity)
Describe the required safety measures:
 End of first part. Part two starts on a new page. 
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GMM – anmälan 8.1-2
_______________________________________________________
THIS PART SHALL NOT BE SENT IN TO THE SWEDISH WORK ENVIRONMENT
AUTHORITY
Investigation, assessment and classification according to 3 §, 5 §
and 7 §
This part of the form follows the procedures of appendix 1 in the provisions AFS 2011:2 on contained use of
genetically modified microorganisms (GMM) and is meant to be used for contained use of GMM within an Factivity. Check Appendix 1 while you are filling out the form. Read also the guide to this form.
If filled out correctly, this part of the form will constitute the documentation required according to 4 § in AFS
2011:2. Therefore, the filled out form 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, but not
sent in together with the notification.
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
If questions 1.a)-e) and 3.f)-h) can be answered with "NO", you only have to fill in this table and not Table 1-3 B
before continuing with the part on safety measures.
1. Potentially harmful traits associated with GMM
a) Is it likely that the recipient organism causes illness in humans, animals, or plants?
b) Is the nature of the vector and the inserted genetic material such that they will
provide the GMM with a phenotype that can be assumed to cause illness in humans,
animals, or plants?
c) Is the nature of the vector and the inserted genetic material such that they will
provide the GMM with a phenotype that can be assumed to have negative effects on the
environment?
d) Is it likely that the GMM causes illness in humans, animals, or plants?
e) Is it likely that the GMM has negative effects on the environment?
3. Factors that increase the probability of harmful effects or of dissemination
into the environment
YES NO
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YES NO
f) Is the nature of the activity or the usage of GMM such that negative effects on the
health of humans or animals, or on the environment may occur?
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g) Is the environment that might be exposed to GMM particularly sensitive (e.g. are
there conservation areas)?
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h) Are extraordinary possibilities to decontaminate GMM in waste or effluent water
required compared to what already exists in the F-activity?
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If the answer on all questions is NO, fill out the list below and proceed directly to point 4.
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 created by:
Updated by:
Updated by:
Updated by:
Date:
Date:
Date:
Date:
GMM – anmälan 8.1-2
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If one or more of the questions have been answered with YES, then a more thorough investigation has
to be done on what harmful effects might occur as well as an assessment on how serious the effects are
and how likely they are to occur. Do this by filling out point 1-3 B before proceeding to the safety
measures at point 4.
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1-3 B IS ONLY APPLICABLE IF ANY OF THE POINTS ABOVE HAS BEEN ANSWERED BY YES
Use one form for each GMM-use, if you have more than one use that needs a more thorough investigation.
Copy point 1-3 B between the dotted lines and paste in as many copies as you need.
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Basic information on the GMM-use
Designation of GMM-use
GMM/recipient organism
Designation (e.g. species, strain etc.)
Risk group1)/corresponding
Vector/corresponding
Designation (e.g. species, strain etc.)
Risk group1)/corresponding, for virus vector
Inserted genetic material
Marker genes/resistance genes etc.
Other genes/parts of genes
Other genetic material (not vector)
Describe the intended function in GMM (not marker
genes)
The origin of the genetic material/donor organism
The donor organism is part of the use
See the provisions from The Swedish Work Environment Authority about Microbiological Work
Environment Risks – Infection, Toxigenic Effect, Hypersensitivity (AFS 2005:1).
1)
1. Identification of potentially harmful effects associated with the GMM
a) Can cause disease in humans, animals, or plants (indicate which disease) or can have
allergenic or toxic effects (on humans)
GMM
Recipient organism (GMM before modification
Vector with inserted genetic material 2)
Vector without inserted genetic material
b) Treatment of disease is missing or (present) prophylaxis is insufficient
GMM
Recipient organism (GMM before modification
Vector with inserted genetic material 2)
Vector without inserted genetic material
c) Establishment in or dissemination into the environment (describe how)
GMM
Recipient organism (GMM before modification
Vector with inserted genetic material 2)
Vector without inserted genetic material
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d) Inserted genetic material can in a natural way be transferred to other organisms (other
species/corresponding)
Via GMM
2)
Via vector or the inserted genetic material
Including donor organism, if it is being part of the use
2. Assessment of the identified potentially harmful effects
Potentially harmful effect
How serious it is
(negligible – low – moderate –
high)
Probability for it to occur
(due to traits of the GMM)
Add more rows if necessary by placing the cursor to the right of the table and press Return (Enter).
3. Identification of factors in the specific GMM-use that can increase the probability of the
potentially harmful effects or of dissemination of GMM into the environment
Factor to consider
Increases probability of
harmful effects (describe how)
Increases probability of
dissemination into the
environment
Nature of activity
e.g. extent and focus according to point
5 in the notification above
What methods are used, e.g.
- aerosol forming procedures
- sharps and needles
- toxic substances (large-scale)
- animal handling (bites, claws) or
secretion of GMM (animal activity)
- other
Characteristics of the external
environment, which may be
exposed
A need for extraordinary
possibilities to decontaminate
GMM in waste and effluent water,
in excess to the normal routines of
the activity
End of the form for the individual GMM-use.
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Paste in a copy of the form for the next use here.
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Consider the result for all GMM-uses when you fill out the form from point 4 and forward,
irrespective of, if either of 1-3 A or 1-3 B, or both of them, have been used.
4. Assessment of which safety measures are required and will be applied
Table 1 a) compulsory measures for laboratory, animal and plant activities
7. Benches and floor are resistant to water, acids, chemicals, solvents, decontamination agents
and are easy to clean
8. Hand washing device
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GMM – anmälan 8.1-2
18. Suitable protective clothing, usually a lab-coat
22. Autoclave associated to the premises
23. Used material containing GMM is decontaminated by method chosen dependent on the
result from the investigation according to 3 § before being washed up, reused or discarded
24. Waste containing GMM is decontaminated by method chosen dependent on the result
from the investigation according to 3 §
25. Specific routines in case of spillage and other incidents
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Table 1 a) measures dependent on the result from the investigation according to 3 §
6. Observation window or corresponding so that occupants can be seen from outside
15. Specific measures are taken against dissemination of aerosols
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17. GMM are kept so that no one can be exposed by mistake or so that unauthorized persons
can get access to it
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21. Efficient protection against vermin (e.g. against rodents and insects)
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b) additions and changes for GMM within animal activity
1. Isolated animal facility (building or secluded area within a building that contains one or
more animal facilities as well as other rooms, e.g. changing rooms, showers, autoclaves or food
storage rooms); requirement based on investigation according to 3 §
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7. Benches are resistant to water, acids, chemicals, solvents, decontamination agents and are
easy to clean; other surfaces if required as a result of the investigation according to 3 §
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26. Animal facilities are separated by lockable doors; requirement based on investigation
according to 3 §
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28. Material and equipment are designed for easy cleaning and decontamination; requirement
based on investigation according to 3 §
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29. Measures are taken to limit the possibility of animals escaping the delimited area
30. Incineration of animal cadavers (recommended)
31. Bedding and waste are decontaminated; requirement based on investigation according to 3
§
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c) additions and changes for GMM within plant activity
1. Greenhouse or growth room with walls, a roof and a floor, intended for growing plants in a
controlled and protected environment; requirement based on investigation according to 3 §
21. Efficient protection against vermin (e.g. against rodents and insects)
33. Control of contaminated run-off water; requirement based on investigation according to 3 §
34. Procedures for transfer of living material between different places, e.g. greenhouse/
growth room and laboratory are designed so that the dissemination of GMM is minimized
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Table 2 compulsory measures for large-scale activities
1. Viable GMM contained in one or more closed systems to separate the process from the
environment
12. Bench, if present, is resistant to water, acids, chemicals, solvents, decontamination agents
and are easy to clean
13. Hand washing device
19. Suitable protective clothing is used within the defined area
24. Used material or waste containing GMM are decontaminated by method that is chosen
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based on the result from the the investigation according to 3 §, before being washed up, reused
or discarded
25. Larger culture volumes, including effluence from the process, are decontaminated before
the fluids leave the closed system for further processing by method that is chosen based on the
result from the the investigation according to 3 §
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Table 2 measures dependent on the result from the investigation according to 3 §
2. Emissions of GMM through exhaust gas from closed systems are controlled
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3. Seals are designed to minimize or prevent release of GMM
6. Closed systems are located within a defined area
10. Special measures to minimize air pollution
17. Aerosol formation is minimized at sampling, addition, extraction or transfer of material
21. Efficient protection against vermin (e.g. against rodents and insects)
22. GMM are kept so that no one can be exposed by mistake or so that unauthorized persons
can get access to them
23. The entire volume from the closed system can be decontaminated in case of an accident
26. Specific routines in case of spillage and other incidents
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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
Mark the Table/combination of Tables that contain the safety measures required
Table 1 a) above contains all safety measures required (Laboratory activity)
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Table 1 a) + b) above contain all safety measures required (Animal activity)
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Table 1 a) + c) above contain all safety measures required (Plant activity)
Table 2 above contains all safety measures required (Large scale activity)
None of the Tables is applicable (other activity)
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Describe the measures required:
Safety level that is sufficient for the GMM-activity
Safety level 1 is sufficient for all the presented GMM-uses
YES
NO
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If safety level 1 is not sufficient, you must notify a new use within an L-activity (safety level 2) or apply
for a permit for a GMM-use within an R-activity.
If you have any comments, please give them here: