Transcript Safety Requirements for Work involving Genetic Modification

Safety Requirements for Work
involving Genetic Modification
Covering risk assessment and
the regulatory and notification
requirements for genetic
modification work
Dr Joanna Marshall
University Biological Safety Adviser
Health & Safety Department
Reference documents and
information source
Health and Safety Department website:
http://www.safety.ed.ac.uk/resources/Bio/
Guidance/Index.html
Various sections
General, Containment Laboratories, Pathogens,
Genetic modification, Work with other materials,
Risk assessment forms, Transport
In particular read:
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Good microbiological practice and containment
Hazard grouping and containment requirements
Preventing injuries from glass and sharps
Requirements under the GMO (Contained Use)
Regulations for work with biological agents
Select others depending on nature of your work
egs - Safety cabinets, Work with blood and tissues,
Work with naked DNA, Work with animals
Individual workers responsibilities
That means YOU!
Individual workers responsibilities
• familiarise yourself with University and
School Health and Safety Policies
• carry out your work safely and in
accordance with these policies using all
control measures specified
• exercise care in relation to yourself and
others who may be affected by your
actions (or inactions)
• report any safety concerns
The legislation
• The Genetically Modified Organisms
(Contained Use) Regulations 2000
Depending on the nature of the work other
legislation may ALSO apply
• for work with plant or animal pathogens
- the Plant Health (Great Britain) Order 1993 (as
amended) or the Specified Animal Pathogens Order
1998
• for deliberate release experiments such as field
trials and some clinical trials
– the Genetically Modified Organisms (Deliberate
Release) Regulations 2002
The Contained Use Regulations
• made under the Health and Safety at Work etc
Act 1974 and the European Communities Act
1972
• replaces earlier legislation
– Health and Safety (Genetic Manipulation) Regulations 1978
– Genetic Manipulation Regulations 1989
– Genetically Modified Organisms (Contained Use) Regulations
1992 and subsequent amending regulations
• the 2000 Contained Use Regulations are
currently in force
• implement various European Directives
for the protection of
• human health and safety and the
environment from contained use activities
involving genetically modified microorganisms (including animal and plant
cultures), and
• human health and safety from GM
animals and plants
in parallel (and so included in the
requirements set out in the remainder of this
presentation)
Genetically Modified Organisms (Risk
Assessment) (Records and Exemptions)
Regulations 1996, as amended in 1997
• made under the Environmental Protection
Act 1990
• for the protection of the environment from
GM animals and plants
Supporting guidance
• A Guide to the Genetically Modified
Organisms (Contained Use) Regulations
2000
• ACGM Compendium of Guidance
• ACGM Newsletters
Also useful is
• categorisations of biological agents in
Hazard Groups 2, 3 and 4 - contained in
the Approved List of biological agents
Terminology
contained use is defined as
“an activity in which organisms are genetically
modified or in which genetically modified
organisms are cultured, stored, transported,
destroyed or disposed of or used in any other
way
and for which physical, chemical or biological
barriers, or any combination of such barriers, are
used to limit contact with, and to provide a high
level of protection for humans and the
environment”
Key point to remember
Having (on the premises) a GMM or a
GMO that has been genetically modified
constitutes “use” under these regulations
and so you must comply fully with all the
provisions of the Contained Use
Regulations
more terminology
the term biological agent is not used and instead
the definition of micro-organism is extended to
include cell cultures as follows
“micro-organism means a microbiological
entity, cellular or non-cellular, capable of
replication or of transferring genetic
material, and includes a virus, viroid, and
an animal or plant cell in culture”
more terminology
organism is defined as
“a biological entity capable of replication or of
transferring genetic material and includes a
micro-organism, but does not include a human
or a human embryo”
more terminology
genetic modification is defined as
“… the altering of the genetic material in an
organism in a way that does not occur naturally
by mating or natural recombination or both …”
the Contained Use Regulations include
examples of techniques that do and do not result
in genetic modification
Examples of techniques
constituting genetic modification
• recombinant nucleic acid techniques
involving the formation of new
combinations of genetic material by the
insertion of nucleic acid molecules,
produced by whatever means outside an
organism, into any virus, bacterial plasmid
or other vector and their incorporation
into a host organism in which they do not
occur naturally but in which they are
capable of continued propagation
another example of GM …..
• techniques involving the direct
introduction into an organism of heritable
genetic material prepared outside the
organism, including micro-injection,
macro-injection and micro-encapsulation
another example of GM …..
• cell fusion (including protoplast fusion) or
hybridization techniques where live cells
with new combinations of heritable
genetic material are formed through the
fusion of two or more cells by means of
methods that do not occur naturally
Key point in defining GM
any technique which alters the genetic
material of an organism using a method
that would not occur by natural mating or
recombination
gene deletions or insertion of multiple copies of a gene
are GM if brought about by listed techniques or artificial
means
as always though there are
exceptions to the rule ………
Techniques which are not considered to
result in genetic modification
• in vitro fertilisation
• natural processes including conjugation,
transduction or transformation
• polyploidy induction
providing they do not involve the use of
recombinant nucleic acid molecules or
genetically modified organisms
Techniques to which these regulations
do not apply
• mutagenesis
• cell fusion of prokaryotic species which can
exchange genetic material through homologous
recombination
• cell fusion of cells of any eukaryotic species,
including production of hybridomas and plant
cell fusions
providing they do not involve the use of
recombinant nucleic acid molecules or
genetically modified organisms as recipient or
parental organisms
Duties under the Contained Use
Regulations
Before any work is started
• notify premises to HSE
– become a registered GM Centre
– all individual buildings used must be detailed
– information goes on public register
• establish a Genetic Modification Safety
Committee (GMSC)
– to review and approve risk assessments
and ….
before each project is started
• assess risks to human health and safety
and the environment
– must be suitable and sufficient
– take into account matters in Schedule 3 or 4
and include the steps specified
– select appropriate containment and control
measures
for GMMs: Containment Levels 1-4
for GMOs: Containment A or B
and ….
• classify the activity
– for GMMs:
– for GMOs:
Class 1-4
non-notifiable or notifiable
(notifiable have greater potential to cause harm to
humans than the unmodified equivalent)
• submit to GMSC for approval
– once approved
• Class 1 GMM and non-notifiable GMO work can
proceed
• remainder need activity notification to HSE
and ….
various general requirements including
• review risk assessments
– regularly
– if may no longer be valid
– if work changes
• keep records
– risk assessment must be recorded and be kept for at
least 10 years after work has finished
• maintain appropriate standards of occupational
and environmental safety (GMP and GOSH)
– in addition to the control and containment measures
• draw up emergency plans (if necessary)
• notify accidents
Individual activity notifications
• required for
– Class 2 and above GMMs
– notifiable GMOs
• must submit full risk assessment and
notification form
• fee payable
• waiting period before work can start
• written consent required before Class 3
and 4 work can start
and ….
further notification required
• if there is any significant change to the
work
• new information becomes available that
effects the risk assessment
• any changes are made to the containment
and control measures
Again
– must first be approved by local GMSC
– fee payable
Notifications and disclosure of
information
• Public register contains
– premises details
– an outline of any notified activity
• All information submitted to HSE is disclosable
UNLESS a claim for confidentiality has been
made and agreed by HSE - but limited grounds
– international relations, national defence or public
security
– if affects matters where legal proceedings involved
– commercial or industrial confidentiality including
intellectual property rights
– confidentiality of a person
and a final point on the
regulations….
Meaning of “work” extended
to cover all contained use activities by any
persons in any place
Health and Safety at Work etc Act 1974
modified
to treat students as if they are employees
of the University
So we now know what we’ve got to
do under the Contained Use
Regulations
do we feel ready to think about our own
work and have a go at a risk assessment?
The bad news
Under the COSHH Regulations
• the number of the Hazard Group indicates
the level of containment under which the
work must be carried out
• identify whether any additional control
measures needed depending on nature of
work and route of infection
Unfortunately not so simple under
Contained Use Regulations
The good news
• Schedules 3 and 4 specify the matters to
be taken into account and steps to be
included
• the containment and control measures are
very similar
Schedule 3 for GMMs
- matters to consider
• potentially harmful effects of
–
–
–
–
the recipient
the inserted genetic material
the vector
the resulting GMM
• characteristics of activity
• severity and likelihood of harm being
realised
Schedule 3 for GMMs
- potentially harmful effects
• disease to humans
• disease to animals or plants
• resulting from inability to treat disease or
offer effective prophylaxis
• resulting from establishment or
dissemination of GMMs in environment
• resulting from natural transfer of genetic
material from or to GMMs
• resulting from interactions of GMMs with
other organisms at premises
Schedule 3 for GMMs
- order of steps
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Overview and summary
RA for human health and safety
Assign provisional containment level
Nature of work
RA for environmental harm
Assign any additional control measures
Classify
Assign corresponding level of
containment
Schedule 4 for GMOs
- matters to consider
• potentially harmful effects of
–
–
–
–
the recipient
the inserted genetic material
the vector
the resulting GMO
• characteristics of activity
• severity and likelihood of being realised
Schedule 4 for GMOs
- potentially harmful effects
• disease to humans
• acting as a human disease vector or
reservoir
• to humans arising from changes in
behaviour
• arising from inability to treat human
disease or offer effective prophylaxis
Schedule 4 for GMOs
- order of steps
• Overview and summary
• RA for human health and safety
• Select containment and protective
measures
• Nature of work
• Review and reconsider control measures
• Decide if notifiable
In parallel
consider risks to environment under the
Genetically Modified Organisms (Risk
Assessment) (Records and Exemptions)
Regulations 1996, as amended in 1997
and assign appropriate control measures
Where to start?
Use the forms available on H&S
Dept website
Form GMMO:
Form GMAni:
It’s simple when its spelt out in
black and white!
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click on Biosafety Guidance on left panel
click on Guidance and Information in index
click on selected items for further choices
Health and Safety Department
website:
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Guidance/Index.html
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