UCL GM number: ..............
GENETIC MODIFICATION SAFETY COMMITTEE
PROJECT RISK ASSESSMENT AND NOTIFICATION FORM FOR WORK WITH
GENETICALLY MODIFIED MICROORGANISMS (GMM)
PART 2 (For a more detailed risk assessment of projects that do not satisfy the
criteria for classification as Class 1 activities)
2.01
Guidance
This part is designed to assist you to carry out and record a full and detailed assessment of the risk of working
with genetically modified microorganisms where the risk level is higher than low or effectively zero, as should
follow from the information provided in Part 1 of the notification. This part must accompany your copy of Part 1,
continuing from section 1.50
N.B. You will need this information for a notification to the HSE if you assess your project as activity
class 2 or above. Fuller information may be found in the Compendium of Guidance, Part 2 A.
2.02
INTENDED RECIPIENT ORGANISM
Name the recipient
micro-organism/s
and vectors to be
used
2.03
Will any of the following organism(s) be
used?
bacteria
viruses
unicellular fungi (e.g.
yeast)
cell lines
2.04
Into which of the ACDP hazard groups is/are the recipient organism/s assigned (give highest)?
2.05
Is any recipient micro-organism a pathogen which is controlled by DEFRA?
2.06
If the recipient micro-organism is a disabled strain, is there any likelihood of complementation or
reversion of the disabling mutations?
PROVISIONAL ASSIGNMENT OF A CONTAINMENT LEVEL FOR THE WORK
2.07
Guidance
Noting the hazard group (section 2.04 above), you should consider any hazards arising from the genetic
modification (described in Part 1). Will this result in a GMM that is more hazardous, less hazardous or about the
same as the host?
Which laboratory containment level do you consider suitable for this work?
(1)
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ASSESSMENT OF RISK TO HUMAN HEALTH AND TO THE ENVIRONMENT
2.08
Guidance These steps should be followed when assessing risk:
1) identify any hazards to health or to the environment;
2) where a hazard exists, assess the severity of the consequences of exposure;
3) assess the likelihood of exposure to staff and others or damage to the environment, under the proposed
working methods;
4) considering both “severity” and “likelihood” together (steps 2 and 3), assess the risk of harm;
5) select suitable measures to control the risk;
6) check back against steps 2 – 4 to ensure that these precautions are sufficient to reduce the risk to “low” or
“effectively zero”.
Full information may be found in the Compendium of Guidance, Part 2A. The steps set out above follow the
sequence recommended in the Compendium (paras. 7ff).
2.09
Consider the pathogenicity, biological properties and intended functions of the materials to be
used in this project. What effects might they have on human HEALTH and the ENVIRONMENT?
Explain the potential severity of the consequences of working with and exposure to:
1. the intended recipient organisms
2. the vectors themselves, and the vectors containing inserted sequences
3. the inserted sequences
4. the genetically modified micro-organisms
Guidance
This covers steps 1) and 2) in the guidance section 2.08 (above). (Cross reference: HSE notification form CU2
section 7 – “hazard identification and evaluation of foreseeable effects”)
2.10
1
2.11
2
2.12
3
2.13
4
2.14
Describe the way that harm might occur from working with these materials and the likelihood
that harm may result.
Take into account: the proposed working methods, any foreseeable failure of equipment or
operational procedures and the people who might be affected.
Guidance
This covers steps 3) and 4) in section 2.08 (guidance above). (Note: This information must be included in the full
risk assessment when a project is notified to the HSE.)
2.15
Please read this statement before completing the next sections.
The majority of GM projects at UCL may be carried out safely in a containment level 1 laboratory
using good microbiological / laboratory practice and with appropriate supervision and training.
2.16
Is this an adequate level of control for the risks of this project?
No
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2.17
Describe the safety measures which you consider necessary to manage the risk.
Guidance
“Step 5” in the guidance summary above. This will determine the Activity Class to which this project belongs.
You must decide:

Which laboratory containment level you consider necessary for this work (2 or 3)?

Whether you need any additional precautions from a higher level of containment (3 or 4)?
(For a list of control measures which determine Activity Class see Table 2 of the UCL guidance which is adapted
for our use from the Compendium of Guidance Part 3A Table 1 and Table 1a of schedule 8 of the GM 2000
regulations as amended in 2005.)
2.18
WASTE MANAGEMENT
Describe the waste management measures which you will apply to the activity. Include:
1. the treatment method,
2. degree of kill,
3. proposed process testing / monitoring measures,
4. ultimate form and packaging for removal from the department).
Note that for activity class 2 and 3 GMMs, the organisms must be inactivated by a validated method inside
the laboratory suite.
(Cross reference: Wording taken from HSE notification form CU2 section 12. This information must be supplied
to the HSE when notifying a project)
2.19
1
2.20
2
2.21
3
2.22
4
2.23
ADDITIONAL CHECK
The following section is designed to assist you to minimise risk by considering other issues
which may have been missed during the risk assessment just completed.
Answer the following questions. N.B. the answers to these questions may require you to
revise or supplement your risk assessment and control measures.
2.24
2.25
2.26
2.27
2.28
2.29
2.30
2.31
2.32
2.33
Are the types and concentrations of disinfectants used for routine cleaning and spillage control effective
against the micro-organisms used in this project?
Will the procedures result in the production of solid waste needing treatment to prevent viable GMM from
leaving the laboratory?
Does your laboratory operating procedure permit the use of sharps (including glass pipettes)?
Can aerosols be generated by the work that contain infective organisms or their products?
Is the recipient micro-organism controlled by DEFRA (e.g. BSE, NDV, avian influenza virus etc.)?
Does the work involve materials which might complement other GMM work in the same laboratory, in such
a way as to increase the risk of either project?
Will the project be carried out in the lab. simultaneously with other agents needing containment higher than
level 1?
Do you propose to work with quantities above 10 L?
Will others be at risk from the work? (e.g. other departmental staff, students, maintenance staff,
contractors, domestic service staff, academic visitors and other visitors)
Does the nature of this work preclude it being undertaken by anyone with a serious skin condition or other
health problems which might make them more vulnerable to infection?
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ASSIGNMENT OF ACTIVITY CLASS
2.34
Compare your control measures (2.17) with the 21 listed in Table 2 (UCL guidance, link below).
Use the containment level number (i.e. column header) to indicate a chosen safety control.
(N.B. The UCL table is adapted for our use from the HSE’s Compendium of Guidance Part 3A
Table 1)
Guidance
This list is available from the guidance document given on the UCL GM web page:
http://www.ucl.ac.uk/efd/safety_services_www/guidance/gm/gm_activity_class.pdf
The highest number selected gives the Activity Class for the project.
2.35
1
2
3
4
5
6
8
9
10
11
12
13
14
15
16
17
18
19
20
21
1
2.36
7
Guidance
In many cases, the Class will be the same as the ACDP
containment level for the intended recipient organism.
However, the nature of the insert or the laboratory
procedures by which the materials will be handled, might
require control elements from a higher category of
containment. In that case, the Class of the project is
raised to that level. For guidance see the Table to Find
Activity Class (UCL guidance). Please note that when
assigning a Class you should only take specific measures
into account if you have identified these as being essential
to control a safety risk to health or to the environment
arising from the genetic modification. You don’t need to
enter something into every box unless you have spotted
one of your control measures listed in the guidance above.
FINAL CHECK
Check the previous sections to ensure that you have included all the risk control measures
necessary to reduce to a low level the risk to human health and to the environment.
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2.37
AUTHORISATION
(when completing Part 2)
The proposer, the Head of Department / Institute and the DGMSO should
sign the form and submit it to the Genetic Modification Safety Committee
for approval for the work to begin.
2.38
The work described in this proposal will be supervised by the proposer and carried out in accordance
with the conclusions of this risk assessment under the authority of the Head of the UCL academic
Department or Head of the postgraduate institute appointed by Council.
2.39
To which Activity Class do you
assign this work with genetically
modified organisms?
1.66
Signature of proposer
(Principal Investigator)
1.67
Name of Head of
Postgraduate Institute
(if applicable)
1.68
Signature
1.69
Name of Head of
Department
1.70
Signature
1
At which laboratory containment level will
you be working?
1
Date:
Date:
Date:
2.43
If any part of this work is to be carried out in a different Department from that specified in section 1.04
(part 1) then consent must be given by the Head of that Department.
2.44
I consent to the work described in this notification being carried out in the rooms in my Department /
Institute specified in section 1.10 (part 1) under the supervision of the research proposer (above)
2.45
Name of Head of
Department / Institute
Date:
2.46
Signature
2.47
Work may not begin until the GM Safety Committee has approved or re-designated the containment level.
The section below is to be completed by the GMSC only.
1.75
This project has been read by and forwarded to Safety Services by the Departmental GM Safety Officer
1.76
Name of GMSO (or
person deputising if
necessary)
1.77
Signature
Date:
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UCL GM number: ..............
COMMENT ON PROPOSED ACTIVITY BY THE GM SAFETY COMMITTEE
(GMSC use only)
The views of the Genetic Modification Safety Committee, as below, must be passed to the Health and Safety
Executive as part of the process of notification to the HSE
APPROVED ACTIVITY CLASS
Name of representative
of the GMSC
Date:
Signature
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