Occupational Health and Safety Directorate
Work with Genetically Modified Animals within BSU’s of Queen Mary,
University of London
THIS DOCUMENT IS INTENDED FOR USE BY ALL PERSONNEL (Staff &
Students) WHO INTEND TO WORK WITH GM ANIMALS AND MUST BE
COMPLETED AND AUTHORISED PRIOR TO WORK COMMENCING.
WHERE NECESSARY (SEE BELOW) IT SHOULD BE ACCOMPANIED BY A
GENETIC MODIFICATION RISK ASSESSMENT AS WELL.
ENVIRONMENTAL RISK ASSESSMENT AND GUIDANCE
Environmental Protection Legislation requires that anyone keeping genetically
modified animals (or plants) must carry out an assessment of the risks to the
environment. In the case of animals this must include risks arising from the escape of
animals. The assessment should also include measures taken by keepers of GMOs
to put in place suitable systems, which minimise such damage resulting from any
escape. Records of these assessments are to be kept for 10 years. The information
in italics below details the parts of the legislation which this document relates to.
- “The Genetically modified Organisms (Risk Assessment) (Records and
Exemptions) Regulations 1996 (RARER) which implements Section 108 (1) of the
Environmental Protection Act, Part VI (EPA), 1990” The College is therefore required by law to ensure that appropriate risk assessments
are carried out and appropriate measures are implemented. The Head of Biological
Services together with the College GM coordinator are responsible, on behalf of the
College, for ensuring suitable measures are in place.
All Home Office Project Licence holders must ensure that a risk assessment on the
GM animals they wish to use has been carried out. All new Project Licence
applications will be required to do this as part of their submission to the appropriate
College committee dealing with such applications. Where the generic assessment
provided for in this document does not adequately cover the animals to be used and
the work to be carried out a further more detailed assessment will be required in
order to comply with the Genetically Modified Organisms (Contained Use
Regulations) 2000.
This generic assessment is intended to include all GM animals (transgenic animals
and animals which have been exposed to GM organisms by any means. Where this
is unclear individuals investigators must seek advice BEFORE commencing work)
that are used within the BSUs of the College unless otherwise stated below.
In all cases where animals are exposed to GM organisms, or other vectors,
they will have been risk assessed under the GM regulations (at containment
level 2) in which case this generic environmental assessment is sufficient. It is
expected that the genetic modification in the vast majority of GM animals used within
the College will present a negligible risk, particularly when combined with BSU
containment measures.
GM animals used will be those generated by well established technology designed to
produce either a gene knockout or where a gene is over-expressed. Animals will
only be obtained from reliable established breeding colonies from authorised
suppliers where a detailed history of the animals can be obtained.
The primary goal in using GM animals is to understand disease processes and to
develop new ways to treat disease. Therefore theses animals will represent a
disease model or a modification of such a model which will either increase or
decrease disease severity.
Where after assessment, the GM animal to be used does not fulfil these criteria
and to ensure conformity use of GM animals will not be permitted until the
principal investigator concerned has completed a risk assessment for each GM
animal.
In most cases GM animals will refer to mice, but this can also include rats and other
animals in the future. This area will be kept under review and the document modified
as appropriate.
The key areas to consider are:
1. Physical containment measures to minimise escape.
2. The likelihood that GM animals could cause harm to humans, other animals
or plants should they enter the environment.
3. Survivability of the GM animal.
4. Likelihood of crossing with UK species.
5. Ecological niche of the animal.
6. Likely route of transfer to the environment.
Risk assessment
In all cases where GM animals are to be used within the college BSU facilities an
environmental risk assessment must be carried out before work can commence. It is
expected that in the vast majority of cases this will be a formality since the risk will be
negligible. There is no set proforma, but any risk assessment should consider and
include the points above and the following: (1) Aim of the experiment. (2) Source of
the genetic material inserted. (3) Details of the GM organism if appropriate. (4)
Nature of the gene product, level of expression and site of expression. (5) How the
GM animals were generated. (6) Possible impact to the environment. (7) Possible
effects on human health.
If after this process a particular GM animal is considered to present more that a
negligible risk, i.e. the consequences of release into the external environment are
more than negligible further measure will be required including a more detailed risk
assessment under the aegis of the GM regulations. Investigators should refer to the
College Health and Safety website for further information and contacts names.
Physical containment measures to minimise escape
All BSUs within the College where GM animals (as defined above) are used provide
a high level of containment to reduce the risk of animals escaping into the external
QM/H&S/0092 07/01/ 2008 (V 1.1), Approved by GMSC 19/05/2008
environment to a negligible level. (a) All rooms where GM animals are housed are
fitted with rodent barriers. (b) All external access doors to the Units are fitted with
rodent barriers. (c) Drains which can potentially provide an escape route to animals
are protected by wire meshing. (e) Infrastructural changes which may take place
within Units must take containment, measures into account as a priority. (f) All
reasonable security measures must be taken to ensure that malicious acts do not
result in the deliberate release of GM animals. Access to BSUs and rooms therein
should only be for authorised personnel. (g) Cages must be maintained in a good
state of repair. (h) Room fabric must be kept clean and free of unnecessary rubbish
as well as being in a good state of repair.
The likelihood that GM animals could cause harm to humans, other animals or
plants should they enter the environment
In the extremely unlikely event that an animal does escape into the external
environment it is considered to be a negligible risk, and would not therefore pose any
more risk than existing wild animals. Where a potential risk has been identified the
case will be referral to the GM local committee for further information and
assessment.
Survivability of the GM animal
It is expected that the survivability of GM animals in the external environment will be
low, since in the majority of cases animals used will be specifically bred laboratory
strains and housed in ideal living conditions (heat light food bedding etc) These
animals will also be more susceptible to predation and disease. Where a potential
risk has been identified the case will be referred to the GM local committee for further
information and assessment.
Likelihood of crossing with UK species
It is expected that the likelihood of crossing with UK species will be low, since in the
majority of cases animals used will be specifically bred laboratory strains which often
have low fecundity. However it is accepted that a small risk here does exist. Where a
potential risk has been identified the case will be referred to the GM local committee
for further information and assessment.
Ecological niche of the animal
Although in principle GM animals would find a suitable niche within the external
environment it is considered extremely unlikely that this would present an
environmental hazard since they would present no more additional problems than
might be encountered by non-manipulated and indigenous species.
Likely route of transfer to the environment
Although it is possible that genetic material could be transferred between compatible
species the likelihood of adverse environmental consequences is considered
extremely low. In the majority of cases the nature of genetic modification will be
considered to be harmless and in some cases deleterious to the host animal, thus
hastening its eradication from the environment. Where a potential risk has been
identified the case will be referred to the GM local committee for further information
and assessment.
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This document is intended to provide guidance and a generic environmental risk
assessment which is designed to cover the majority of GM animals used within the
College. Since a high level of containment is available with the College BSUs it is
expected that in only a small minority of cases, where work with GM animals is being
carried out, will a further review of the assessment be required.
Compliance with other legislation
It is important that project licence holders carrying out work as described above
ensure that all personal licence holders understand and are fully aware of the
contents of this document. Additionally is expected that ALL investigators working
with GM animals will have complied with GM, COSHH, Home Office and other
appropriate regulations.
Declaration
I have read, understood and agree to comply fully with the above. The GM animals
used under my Home Office Licence comply with this generic assessment.
NAME
……………………………………..
DEPARTMENT/DIVISION
……………………………………..
HOME OFFICE LICENCE PROJECT NUMBER
SIGNED
………………………………… DATE
……………………………..
……………..
------------------------------------------------------------------------------------------------------GM COORDINATOR
SIGNED
……………………………………..
………………………………… DATE
……………..
HEAD OF BIOLOGICAL SERVICES ……………………………………..
SIGNED
………………………………... DATE
……………..
Copies of this signed document will be kept by the College GM co-ordinator, the
Chair of the local GM safety committee and the Head of Biological services.
FOR GUIDANCE, AND WHERE TO OBTAIN FURTHER HELP
Investigators should refer to the College Health and Safety website for further
information and contacts names.
For the full (official) text of the Genetically modified Organisms (contained Use)
Regulations 2000, plus detailed explanations and guidance, you may find it useful to
refer to the booklet "A Guide to the Genetically Modified Organisms (Contained Use)
Regulations 2000" (HSE Books, ISBN 0-7176-1758-0) copies of which are held by
the College GMSC Chair, GMSC Coordinator and the College Safety Advisers.
You should also consult the SACGM Compendium
(http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/index.htm
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of
).
Guidance
The
Compendium gives advice on how to undertake the required risk assessment. It also
gives guidance on the containment measures required and the classification of
activities with GM animals (Part 5). Further information can also be found at the HSE
website (www.HSE.gov.uk ). The SACGM newsletters can also be found at
http://www.hse.gov.uk/aboutus/meetings/sacgmcu/meetings.htm
Details of the Environmental Protection Act 1990 (c43) can be found at
http://www.hmso.gov.uk/acts/acts1990/Ukpga_19900043_en_1.htm (copies can be
obtained from HM Stationers ISBN 0105443905).
For further guidance on the categorisation of biological agents please see: Advisory
Committee on Dangerous Pathogens (ACDP)
http://www.hse.gov.uk/pubns/misc208.pdf
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