Doc No: HAS-FRM-0029
Issue: 2
Date: 11 November 2013
Page: 1 of 5
Genetically Modified Organisms and Biological Agents - Project
Proposal and Risk Assessment form
Project Reference (to be assigned by the GMSC):
(HSE premises licence numbers as follows: GM972 for Diamond, GM975 for ISIS, GM3067
for RCaH)
A: PROJECT OVERVIEW
Applicant
Date
Project Title
Confidential:
Yes
Name of project leader:
No
Organisation:
Contact details
Staff involved in the project
General description of project, including the aim of the work
Location:
Is any of the material listed under the following regulations
SAPO
Yes
Schedule 5
Yes
This section to be completed by the GMSC and BSO
Final Assignment of GM activity class:
GMSC comments:
Date:
HSE approval needed:
DEFRA approval needed:
Proposal Approved/Rejected:
Appendix attached to GM assessment:
HSE approval granted:
DEFRA approval granted:
Date:
No
No
Doc No: HAS-FRM-0029
Issue: 2
Date: 11 November 2013
Page: 2 of 5
Amendment in place:
B: PROJECT RISK ASSESSMENT
Consideration of potential properties of the GMM to determine if there are any potential
mechanisms by which it could present a hazard to human health and/or the environment.
i)
Hazards associated with the recipient micro-organism (e.g. ACDP and SAPO
classification, transmission, host range etc)
a) Human
b) Environmental
ii)
Hazards arising directly from the inserted genetic material (e.g. does it code for a
toxin, an oncogenic protein or anything which could cause harmful biological activity)
a) Human
b) Environmental
iii)
Hazards arising from the alteration of existing pathogenic traits (e.g. alteration of
host range or tissue tropism)
a) Human
b) Environmental
iv)
Potential hazards of sequences within the GMM being transferred to related
micro-organisms (e.g. via gene transfer or recombination, survivability in the environment)
a) Human
b) Environmental
Doc No: HAS-FRM-0029
Issue: 2
Date: 11 November 2013
Page: 3 of 5
Consideration of the likelihood that, in the event of exposure, the GMM could actually
cause harm to human health or be a risk to the environment. Include consideration of the
ability of the GMM to become established in the host and consideration of the probability
that rare events will occur. Supporting evidence and references should be provided.
Consideration of the work to be undertaken and a detailed review of the control measures
to protect against risk of harm to human health and the environment. Supporting
evidence and references should be provided. (Controls to consider e.g. reducing aerosol
generating procedures, waste disposal and disinfection procedures, elimination of sharps,
lab equipment and procedures, consider vulnerable workers)
Assignment of provisional Containment Level to protect human health. (This is based on
the information provided in all the answers given above)
1
2
>2
Assignment of provisional Containment Level to sufficiently protect against harm to the
environment. (This is based on the information provided in all the answers given above)
1
Assignment of the activity class
2
>2
1
2
>2
Doc No: HAS-FRM-0029
Issue: 2
Date: 11 November 2013
Page: 4 of 5
C: SIGNATURES AND REVIEW
Person responsible for project
Signature:
Date:
Name:
Person completing risk assessment (if
different from above)
Date:
Signature:
GMSC chair
Signature:
Date:
Name:
BSO
Signature:
Date:
Name:
Name:
Annual Review
If the GMM risk assessment is modified a new version must be submitted.
Comments
Review Date:
GMSC Chair:
Person responsible
for the project
BSO
Comments
Review Date:
GMSC Chair:
Person responsible
for the project
BSO
Doc No: HAS-FRM-0029
Issue: 2
Date: 11 November 2013
Page: 5 of 5
Comments
Review Date:
GMSC Chair:
Person responsible
for the project
BSO
Comments
Review Date:
GMSC Chair:
Person responsible
for the project
BSO
Comments
Review Date:
GMSC Chair:
Person responsible
for the project
BSO
Comments
Review Date:
GMSC Chair:
Person responsible
for the project
BSO