QUEEN MARY, UNIVERSITY OF LONDON
RISK ASSESSMENT FORM: CONTAINED USE ACTIVITIES INVOLVING GENETIC MODIFICATION
As required under regulation 6 of the GENETICALLY MODIFIED ORGANISMS (CONTAINED USE) REGULATIONS 2000
INFORMATION ON THIS PAGE IS CONFIDENTIAL
1.PROJECT SUPERVISOR
(Person who has overall responsibility for the work. Include Name, full address, e-mail and telephone numbers)
2.DEPUTY PROJECT SUPERVISOR
(Responsible person in the absence of the project supervisor. Include Name, full address, e-mail and telephone numbers)
3.PROJECT WORKERS
To include qualifications, training and experience with GM work. All GM workers (and any others impacted by the work) should sign at section 24 to indicate that the assessment has been read and understood. Some GM workers (for GM Class 3 activities and others where a risk assessment determines) require Health Surveillance and the College Occupational Health Service must be contacted to ensure adequate monitoring. See ‘notes for guidance’ below and GM Policy / Procedure documents for further information). Updates in Project Workers should be notified to the College Biological Safety Adviser.
4.LABORATORY/ROOM WHERE THE WORK WILL BE CARRIED OUT
5.DESCRIPTIVE TITLE OF PROJECT
6.PROJECT SUMMARY FOR NON-GM EXPERT PEER REVIEWERS
Provide a short (one or two paragraphs) summary which describes in terms understandable to a non-GM expert, the nature and aims of the project, and why the use of GMOs is important for this work. In lay terms, note which feature(s) of the work produces significant risk(s) to human health and the environment, and what containment measures are appropriate. If your project generates negligible or low risk, explain why.
7.SCIENTIFIC OVERVIEW OF PROJECT
(Please complete a brief scientific resume of the project. Additional information can be attached if necessary)
8.ORGANISMS AND VECTORS
(Please list the organism, vectors and inserts that will be used in the project, this should include the source. This can be done in generic terms where appropriate e.g. K12 strains. For cell cultures, give strain/line information as well as species. If GMMs have been imported into the site, information on the construction of the GMM must be obtained from the supplier)
9.IDENTIFICATION OF POTENTIAL HARMFUL EFFECTS AND HAZARDS IN RESPECT OF HUMAN HEALTH
(This section looks at the possible harmful effects/hazards to human health from the pathogenicity, biological effects and toxicity of the host organism, foreign gene product and the mobility of the plasmid. Therefore consider host, vector, final GMM and survivability. Also severity of effects if an accident was to occur)
10.IDENTIFICATION OF POTENTIAL HARMFUL EFFECTS AND HAZARDS TO THE ENVIRONMENT
(This section considers the possible harmful effects/hazards to the environment. What is the likelihood of release/escape of organism from the containment laboratory? Consider host, vector, final GMM, scale and survivability. Also severity/consequences if an accident was to occur)
11.ASSIGNMENT OF PROVISIONAL CONTAINMENT LEVEL
(This considers the containment level necessary to control risk of host and by making a judgment about whether the modification(s) carried out will result in a GMM, which is more/less hazardous, or about the same)
12.POSSIBILITY OF THE ABOVE EFFECTS OCCURING: RISK TO HUMANS
(Consider the scale of cultures used and their frequency, production of aerosols, use of sharps, any other hazardous procedures; Use the risk estimation table under ‘notes for guidance’)
13.POSSIBILITY OF THE ABOVE EFFECTS OCCURING: ENVIRONMENTAL CONSIDERATIONS
(Consider theoretical modes of transmission (e.g. drains, air), can the environment support the survival of the GMM, are there species in the environment, which are susceptible to infection by the GMM; Use the risk estimation table under ‘notes for guidance’)
14.DOES THE LABORATORY MEET THE REQUIREMENTS FOR SMALL SCALE ACTIVITIES INVOLVING GMMs?
15.WASTE CONTROL
(All contaminated waste must be rendered non-viable. This means the complete or partial destruction of GMMs so as to ensure that any contact between GMMs and the environment is limited to an extent commensurate with the risks identified in the risk assessment and to provide a high level of protection for humans and the environment. Consider inactivation methods (e.g. autoclave, disinfectants), the degree of kill and proposed testing/monitoring measures)
16.ARE ALL WORKERS FAMILIAR WITH LOCAL RULES AND GM REGULATIONS ON SAFE WORKING AND DISPOSAL METHODS?
17.ASSIGNMENT OF CONTAINMENT LEVEL AND CLASS
(After considering all the activity and environmental considerations into account revise, if necessary, the provisional containment level so that all risks are controlled Work assessed as greater than class/containment level 1 will require additional information and specific HSE notification)
Containment level……………Class……………
All projects must be reviewed regularly to ensure that the risk assessment is still valid and that the work has not changed significantly – If this is the case the project must be reassessed – see section 23.
18.ADDITIONAL COMMENTS
(This should include: Has the above project been assessed under the COSHH regulations? If using radioactivity has this been approved? Any other relevant information not covered above)
19.COMMENTS OF THE GMSC
(Please note that work at class/containment level 1 cannot start until approval from the local GMSC has been granted)
INFORMATION ON THIS PAGE IS CONFIDENTIAL
20.RISK ASSESSMENT PREPARED BY:
Name………………………………………
(In signing this you agree that work will not commence until GMSC approval has been granted)
Date………………………………………
Signature………………………………………
21.APPROVED BY GMSC
Name………………………………………
Date………………………………………
Signature………………………………………
22.PROJECT REFERENCE NUMBER:
NOTES FOR GUIDANCE, AND WHERE TO OBTAIN FURTHER HELP
This form can be obtained as a word file from the College intranet health and safety website () or from Mark Ariyanayagam (College Biological Safety Adviser, tel 13-8378; email ) or Martin Carrier (GMSC Chair, tel 13-2104 or 2218; e-mail ). In the first instance completed forms can be sent as an attachment by e-mail to the College Biological Safety Adviser. The form can be lengthened/shortened as required.Members of the GMSC can also provide guidance on the completion of this form.
For the full (official) text of the Regulations, plus detailed explanations and guidance can be found at You should also consult the SACGM Compendium of Guidance () The Compendium gives advice on “inherently safe microorganisms”, and how to undertake the required risk assessment. It also gives guidance on the containment measures required and the classification of activities with GMOs. Further information can also be found at The HSE website () and the College Website (). SACGM information, newsletters etc can also be found at .
For guidance on the categorisation of biological agents please see: Advisory Committee on Dangerous Pathogens (ACDP) or
To determine GM worker Health Surveillance requirements, contact the College Biological Safety Adviser for initial advice on requirements and the College Occupational Health Department (tel 13-8700) for registration and monitoring. Part 1, Pages 17-20 of the SACGM Compendium of Guidance details instances where Health Surveillance may be required.
Risk Estimation Table:
Consequences of hazard /Likelihood of Hazard
High / Medium / Low / NegligibleSevere / High / High / Medium / Effectively zero
Modest / High / Medium / M/L / Effectively zero
Low / Minor / M/L / Low / Low / Effectively zero
Negligible / Effectively zero / Effectively zero / Effectively zero / Effectively zero
THEFOLLOWING PAGES CAN BE REMOVED AND ATTACHED TO THE NEW VERSION OF THE ASSESSMENT
23PROJECT RISK ASSESSMENT REVIEW.
This assessment should be periodically reviewed and updated as necessary over the active life of the project. Reviews should be conducted at least once every 3 years, unless specified otherwise by the GMSC. Please forward the College Biological Safety Adviser, the new version of the assessment and keep a copy of the old version for at least 10 years after work has ceased (‘work’ includes storage of GM material). Significant amendments require consideration and approval by the GMSC; GM Class 2 or 3 activities also require HSE approval. Cessation or move to another institution of a Project also requires notification to the College Biological Safety Adviser / GMSC and for GM Class 2 or 3, also to the HSE.
VERSION / DATE OF LAST REVIEW: / SIGNATURE OF GM PROJECT SUPERVISOR24GM WORKERS AND ASSOCIATED STAFF / STUDENTS
This risk assessment should be easily available (e.g. in the laboratory) and where it can be read by all GM workers and others who may be impacted (e.g. those not on the project but working in the same laboratory) by the work.All those working or impacted by this project should read the assessment before beginning work. Sign below to indicate that you have read and understood the latest version of the assessment.If required, please extend the table to include more names.
VERSION / PRINT NAME / SIGNATURE / DATEVERSION / PRINT NAME / SIGNATURE / DATE
1
QM/H&S/0055 GM risk assessment form
Aug 2009version 2.3