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Final Risk Class:
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GM Committee Ref:
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Biol. Services. Ref:
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HSE Ref (if appropriate): 1___________
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= all to be allocated by GM-BSO
Generation and use of genetically modified cell cultures
GM Centre number: 318
GM-BSO: Dr Stuart Nicklin
GM-BSO - Contact details: BHF GCRC, 126 University Place, University of
Glasgow G12 8TA. Tel: 0141-330-2521; Fax: 0141-330-6997;
Email: stuart.a.nicklin@clinmed.gla.ac.uk
1.
SUMMARY
Title of Project:
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Name of Proposer:
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Contact details:
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Head of Unit/Group:
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Personnel involved:
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Department:
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Facilities employed for the work: …………………………………………….
Proposed class of work (1, 2 or 3): ……………………
Does the project use animals:
yes/no
If yes please give details and review and attach the generic risk assessment for
rodent work:
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1.
Overview:
Please give sufficient background to the project for committee members to
understand the work to be undertaken. This should include but is not limited to the
type of vector and any attenuating mutations and/ or modifications to tropism, the
expected phenotype of the encoded insert and the nature of the work (including in
vivo work) that is planned
2.
Hazard identification with respect to human health - predicted properties of the
GMMO:
(a)
(b)
(c)
(d)
(e)
Consider in turn:
the host or recipient organism,
the vector used to insert the genetic sequence, e.g. mobilisability,
origin of the genetic material,
activities of the inserted genetic sequence and of the product,
the resultant GMMO - overall and following the above, is it more, equal or less
hazardous than original host, such as increase/decrease in oncogenicity,
pathogenicity or extended tropism?
Some factors to consider will include: disease, allergy or toxicity to humans; refer to
classification systems such as the ACDP’s “Categorisation of biological agents
according to hazard and categories of containment”.
Adverse effects resulting from:
inability to treat human disease/off prophylaxis,
establishment or dissemination of GMMO,
inadvertent transfer of inserted genetic material to other organisms where it
could give
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rise to harm,
presence of adventitious agents.
3.
Evaluate the likelihood of the harm to human health, if exposure were to occur:
From the identified hazards, what is the probability of and the severity of harmful
consequences actually occurring (= risk). For example, the ability of the GMMO to
establish an in-vivo infection and any subsequent propagation.
Consider theoretical risks and the justification why these risks may not occur or are
infinitely small.
4.
Determine provisional containment level:
Read across from the table of Schedule-8 and determine class of activity. The
highest stringency level equates to class, i.e. where level-2 plus level -3 measures
are required that directs to a class-3 project.
5.
Consideration of the nature of the work with respect to human health and
assignment of additional controls:
Based on the (uncertain) nature of the GMMO, are additional measures required?
Are there any particular hazardous or non-standard operations to be performed, e.g.
sonication, maceration, large-scale, in-vivo, which could increase the risks to
practitioners? Will this require revision of the provisional containment measures
(CMs)/risk class?
6.
Risk Assessment for environmental harm (escape from containment):
Evaluate the identified hazards and the severity and likelihood of harmful
consequences occurring, (risk), if the organism was to escape from containment
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including during waste disposal. Harm is defined as affecting numbers or functioning
of organisms in an ecosytem. Follow the same sequence as above: hazard
identification, determine probability of hazards being realised, consequences of the
hazards being manifest and risk of harm occurring (probability x consequences).
Determine the measures that will be necessary to control any harm being realised
and justify as appropriate.
Factors to consider will include: capacity of GMMO to survive, establish, disseminate
and or displace other GMMOs, potential for gene transfer to other organisms, e.g.
increased plasmid transfer rates.
Pathogenicity to animals/plants, (e.g.
MAFF/SERAD classification of Specified Animal Pathogens and Plant Health
Orders), gene expression products that are toxic to other organisms, phenotypic and
genetic stability, no. of organisms released and the potential for exposure,
characteristics of environment.
Are the hazards/risks sufficiently controlled, effectively to zero risk, (include
justification if necessary), if not what additional CMs are required (Schedule-8)?
7.
Consideration of the nature of the work to be undertaken and a detailed review
of the control measures:
Are there any non-standard procedures that might increase risk?
What control measures and monitoring procedures are to be used?
Please discuss decontamination procedures and methods and routes of waste
disposal.
8.
Final classification of proposal:
Revise provisional classification to take account of all the other factors in stages 5
and 6 of the risk assessment (RAs). Read across from the Table the measures
necessary to apply. (Note that measures adopted for factors unrelated to the RAs
such as convenience, product protection, are irrelevant when determining
classification). What Notification requirements then follow? Is derogation against
certain measures or for reduced classification required or worth pursuing?
FOR COMMITTEE USE ONLY
Date proposal examined by Genetic Modification Safety Committee:
Approved Not approved (DELETE ONE)
Signature of GM-BSO:
Date:
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