gm assessment masterclass - istr 2019 bso meeting/… · gm assessment masterclass. overall...
TRANSCRIPT
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GM ASSESSMENT MASTERCLASS
Giving Expert Advice on GM Risk
Assessments
Jonathan Gawn University Biological Safety Officer
University of Manchester
David Brown Biosciences Technical Lead (Contained Use),
HSE Microbiology and Biotechnology Unit
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Your morning…
Part 1: Reviewing risk assessments What to look for, good questions to ask, how to deal with uncertainties, and ways of
tackling tricky classifications (e.g. lentiviruses; CRISPR/Cas9)
Comfort break
Part 2: Notifying HSEWhat to include, and what not to say to avoid requests for additional information
Lunch
GM ASSESSMENT MASTERCLASS
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Overall objective…
Get an appreciation of the things to consider
when reviewing risk assessments as a
competent individual (class 1) or as part of a
genetic modification safety committee (class 2
and above).
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Regulation 8 - Advice from a genetic modification safety committee
A person responsible for contained use must obtain advice on a risk assessment from either—
(a) a person; or [class 1 only](b) a genetic modification safety committee [class 2 – 4]
with expertise in risk assessment relating to contained use.
GM Safety Committee
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GM Safety Committee• Review proposals involving Genetic Modification and consider whether
the proposed activity class and control measures are appropriate
• Review proposals involving work with biological agents and consider whether the containment and control measures are appropriate
• Consider whether the competence of those involved in each proposal are sufficient to carry out the work safely
• Consider queries received from the Health & Safety Executive concerning proposals
• Develop an inspection program and monitor progress and findings
• Consider accidents and incidents related to GMOs and biological agents
• Advise on general laboratory practice with regards to safety
• Consider whether arrangements for health surveillance and workplace monitoring are adequate
• To advise on the drawing up of local rules to cover work involving GMOs and biological agents
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The core mission…
Assurance that:
1. All reasonable hazards have been identified
2. Control measures are appropriate
3. The GM activity classification is correct
4. Information clear and appropriate enough to send to HSE (class 2+)
…through challenging the risk assessment and it’s assumptions
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An important point
GM risk assessments are predictive
Not knowing is not a reason for not
assessing
Need to consider potential for harm
• To people
• To the environment
…as a function of what is being donewith the GMO – ACTIVITY BASED
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• One-word answers or poor justification
• Not describing mechanism of
disablement/attenuation or possibility of reversion
• Limited prediction of the final properties of a GMM
• In vivo activities - probably involves the greatest risk
of worker exposure
– Mentioned and not assessed
– Poorly assessed
• Environmental hazards overlooked
– Survivability, dissemination and transfer of genes
• Containment and control measures not linked to
identified hazards
Shortcomings in risk assessments
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• Identify the most hazardous GMO
• E.g. Transduced cells are unlikely to be the most hazardous
part – the vector is!
• Don’t forget the environment• Don’t get unduly caught up in the technical
• E.g. What might it do… not how is it made…?• Watch for:
• Non-standard control measures
• Use of ‘central’ facilities and equipment• Vague references to animal work, needles and scalpels
• ‘Unnecessary’ use of cabinets and gloves• Using ‘no evidence that…’ to dismiss a hazard
Top tips
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Classification
• Determined by the control measures specifically required to
mitigate risks to human health and the environment
– Activity, not just the GMM!
• For class 1, it must also be justified that it is of no or negligible risk to human health/environment
• Not determined by standard good practice in the labs
– Labs built to CL2 standard
– Cabinets used to protect the product
– Gloves/PPE always worn
– Training records kept
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What makes it class 2?
If the risk assessment identifies the following controls as being
required to control risks then it is class 2:
– Safety cabinet or other measures to minimise aerosol risks (to
protect human health/environment, not the work)
– Restricted access (activity specific, not routine)
– Gloves (to protect human health, not the work)
– Records of training (specific to the activity)
Or
The nature of the organism or the activity make it more likely that it
could cause harm to human health/environment
Or
You cant justify that it is of no or negligible risk to human
health/environment
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Playtime!
• You are, the UK’s biggest GMSC, and I am its Chair!
• A researcher is going to present a project regarding
the use of Lentiviral vectors
• What questions are you going to ask?
• What comments are you going to make?
• What will you ask the researcher to change or do
next?
• Ask them!
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Classifying Lentiviral Vectors
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The problem…?
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Risks from inserted material
LV vector
Oncogene
Reporter
Cytokine
Not just transgene that needs to be considered…
Toxin
CRISPR Cas9gRNAsiRNA
gRNA
CRISPR/Cas9
Unknown
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Restricted
tropism
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Broad tropism Increased likelihood of
harm
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Increased likelihood of
harm
Required control
measure
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RESTRICTED ACCESS
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