Health and Safety Services

GENETICALLY-MODIFIED ORGANISMS APPLICATION FORM

AND RISK ASSESSMENT

Date application received: /

Local BSO

(Office use only) /

University

BSO

(Office use only) / Project No., provisional & final Hazard Group: / (Office use - UBSO only)
Date next review due:
This form must be completed when any Genetic Modification work is to be carried out. Guidance to help you complete this form is available (link). You must not start work until the appropriate level of approval has been obtained for both the project and the laboratory facilities.
1. School/Division/ Research Group:
2. Principal areas where the work will be done: include building, floor & room no’s, type of room e.g. cold room, centrifuge room, research lab / 3. Commercial confidentiality requested:
Underline as appropriate /

Yes / No

4. Principal Investigator:
Title, forename, surname
Employer, if not University: / Position:
Phone
E-mail
5. Other Investigators:
Title, forename, surname
Include all persons involved in the experiment or users of products
For each person named, state the employer, if not University staff or student / 6. Positions:
e.g. academic staff, technician, research student, research associate,
etc.
APPROVALS REQUIRED
7. I certify that I and all co-workers will (a) sign the reverse of this form to indicate that they are familiar with the contents of this Risk Assessment, (b) attend appropriate safety courses (c) carry out the work in accordance with the provisions of the Genetically Modified Organisms (Contained Use) Regulations 2000 and other relevant legislation and (d) obtain ethical approval where required.
Name of Principal Investigator (printed): / Signature / Date
For all applications:
8. I agree with the risk assessment for this project.
Name of external referee 1 (printed): / Signature / Date
For CL2 and above, or in cases of disagreement or doubt:
9. I agree with the risk assessment for this project.
Name of external referee 2 (printed): / Signature / Date
10. I certify that the Local GM Safety Committee has fully approved the risk assessment and other details submitted on this application.
Name of Local BSO (printed): / Signature / Date
11. I certify that the labs in which this work will be done fully satisfy the requirements for the ACDP Containment Level and that all personnel have received appropriate training and health surveillance.
Name of Head of School/Faculty or nominated deputy (printed): / Signature / Date
To be completed if CL2 or above:
12. I confirm that HSE have been notified of this proposed work and no objection has been received within 45 days.
Secretary of University GM Safety Advisory Group / Signature / Date
13. I approve this application.
University BSO / Signature / Date
14. I approve this application which has been considered by the University GM & Biohazards Advisory Group.Chairman of University GM Safety Advisory Group / Signature / Date
Office Use Only:


ASSESSMENT

15. Title of Project:
Keep as brief as possible
16. Brief Summary of Project: Please write ¼ - ½ page, defining all abbreviations used.
17. Summary of classification of GMO:
From box 39 – see box 42 for extra precautions / Class I Class 2 Class 3
Underline as appropriate
18. Summary of COSHH assessment for any cell culture work: / Class I Class 2 Class 3
Underline as appropriate
19. Project involves viruses or transgenic multicellular eukaryotes
Check boxes that apply and fill in special forms obtainable on the H&S Services website , by following the hyperlinks to the right or from the University Biological Safety Officer. Relevant sections of the ACGM Compendium of Guidance are given in parentheses.
Important - complete Boxes 40 - 47 below for all proposals, whether or not a Brenner Risk Assessment is carried out. / For viruses, use the special form
(Part 2B – human & animal; Part 2C – plant)
Use the special animal form for the following:
Mammals (pre-existing transgenics)
(Part 2E & 3E)
Mammals (produced during experiment)
(Parts 2E, 3D & 3E)
Other vertebrates (including fish)
(Parts 2E 3D & 3E)
Invertebrates (including insects)
(Parts 2E, 3D & 3E)
Use the special plant form for the following:
Plants
(Parts 2D & 3B)


Section No. ______

Brenner’s Hazard Identification Scheme for GM of Microorganisms
For restrictions on validity of this method, see Appendix, note 20
20. Describe Host-Vector System: / Check box if human or simian material
21. Is the host: / specially-disabled disabled wild-type
Underline as appropriate
22. Give reason
23. ACDP classification of host:
24. Is the vector: / non-mobilisable mobilisation-defective self-mobilisable
Underline as appropriate
25. Give reason:
26. Access Factor
(if used -see note) / 1 10-3 10-6 10-9 10-12

Underline as appropriate

27. Origin of nucleic acid insert
28. Specification of insert
29. Name the gene product:
30. Will the gene product be expressed? / Yes Probably Possibly No
Underline as appropriate
31. Expression Factor
(if used -see note) / 1 10-3 10-6 10-9 10-12
Underline as appropriate
32. Give reason:
33. Gene product biologically active if expressed? / Yes Probably Possibly No
Underline as appropriate
34. Known biological activity
35. Likelihood of harmful effects?
36. Damage Factor
(if used -see note) / 1 10-3 10-6 10-9 10-12
Underline as appropriate
37. Give reason
38. Overall Hazard Identification Value
(if used -see note) / 1 10-3 10-6 10-9 10-12 10-15 10-18 10-21
10-24 10-27 10-30 10-33 10-36
Underline as appropriate
39. ACDP Containment Level / 1 2 3 4
Underline as appropriate
40. Indicate Scale of work / Small scale (e.g. lab) Large scale (e.g. pilot plant)
41. Nature of experimental activities
42. Describe any specific precautions required

Environmental Risk

43. State likelihood of
(a) accidental release
(b) survival after release: / (a) High Medium Low Negligible
(b) High Medium Low Negligible
Underline as appropriate
44. Consequence of hazard: / Severe Medium Low Negligible
Underline as appropriate
45. Overall environmental hazard: /
High Medium Medium/Low Low Effectively zero
Underline as appropriate
46. Special measures necessary to protect the environment & details of waste disposal and emergency clean-up procedures:

Health Surveillance

47. As a result of this risk assessment, what immunisation / health surveillance is required?

General GM form, 2005 Page 1 of 3