Download Environmental Risk Assessment - Health and Safety Directorate

Health and Safety Directorate
Work with Genetically Modified Animals within Biological Services Units
(BSU’s) of Queen Mary University of London (QMUL)
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.
GENERIC GENETICALLY MODIFIED ORGANISMS (GMO)
ENVIRONMENTAL RISK ASSESSMENT AND GUIDANCE
United Kingdom 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. (* a separate template is available)
- “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” QMUL is therefore required by law to ensure that appropriate risk assessments are
carried out and appropriate measures are implemented. The Head of Biological
Services Unit (BSU) together with the QMUL GMSC are responsible, on behalf of
QMUL, 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
QMUL 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) 2014 (or in case of a deliberate/intentional environmental release of GM
material, the Genetically Modified Organisms (Deliberate Release) Regulations 2002).
This generic assessment is intended to include all GM animals (i.e. transgenic
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 (and other similar facilities, e.g. in vivo rooms) of QMUL
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 noted above in which case this
generic environmental assessment is sufficient for the purposes of the Environmental
Protection Act.
Where after assessment, the GM animal to be used does not fulfil the criteria
covered under this generic risk assessment and to ensure compliance, the use of
GM animals will not be permitted until the Principal Investigator concerned has
completed a risk assessment for each GM animal type.
In most cases, GM animals will refer to mice, but this can also include rats and other
animals in the future. This 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.
Generic Environmental Risk Assessment for QMUL
In all cases where GM animals are to be used within QMUL BSU (and similar)
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.
Assessment for QMUL:
It is expected that the genetic modification in the vast majority of GM animals used
within QMUL 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 these animals will represent a disease
model or a modification of such a model which will either increase or decrease
disease severity.
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
QMUL_HS_089_ Environmental Risk Assessment (GMO) _07/01/ 2008 (V2_21 March 2016)
assessment under the aegis of the GM regulations. Investigators should refer to the
QMUL Health and Safety website for further information and contacts names.
Physical containment measures to minimise escape
Assessment for QMUL:
All BSUs (and similar facilities) within QMUL where GM animals (as defined above)
are used provide a high level of containment to reduce the risk of animals escaping
into the external 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
Assessment for QMUL:
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 GMSC for further information and assessment.
Survivability of the GM animal
Assessment for QMUL:
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 GMSC for further information
and assessment.
Likelihood of crossing with UK species
Assessment for QMUL:
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 GMSC for further
information and assessment.
Ecological niche of the animal
Assessment for QMUL:
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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
Assessment for QMUL:
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 GMSC for further information and
assessment.
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
QMUL. Since a high level of containment is available QMUL BSUs (and similar
facilities) 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
INSTIUTE / SCHOOL
……………………………………..
HOME OFFICE LICENCE PROJECT NUMBER
SIGNED
………………………………… DATE
……………………………..
……………..
------------------------------------------------------------------------------------------------------GMSC BSO
……………………………………..
SIGNED
………………………………… DATE
……………..
HEAD / MANAGER OF BIOLOGICAL SERVICES UNIT (BSU) - name and facility
location/s
…………………………………………………………………………………………..
QMUL_HS_089_ Environmental Risk Assessment (GMO) _07/01/ 2008 (V2_21 March 2016)
SIGNED
………………………………... DATE
……………..
Copies of this signed document will be kept by the QMUL GMSC BSO, the Principal
Investigator and the Head / Manager of Biological Services Unit (BSU).
FOR GUIDANCE, AND WHERE TO OBTAIN FURTHER HELP
Principal Investigators should refer to the QMUL Health and Safety website
http://hsd.qmul.ac.uk/ for up to date information and contacts names.
This form can be obtained as a word file from the QMUL Health and Safety Directorate
website (http://hsd.qmul.ac.uk/ ).
Signed and Completed forms should be sent as an attachment by e-mail to the QMUL
Biological Safety Adviser / GMSC BSO.
QMUL Key Contacts:
First Contact –
QMUL Biological Safety Adviser and GMSC
([email protected] , tel 0207 882 8378)
BSO:
Dr
Mark
Ariyanayagam
Additional Contacts QMUL GMSC Chair: Dr Martin Carrier ([email protected] , tel 0207 882 2218
QMUL GMSC Deputy Chair: Dr Matthias Dittmar ([email protected] , tel 0207 882
8119)
QMUL GMSC members: names and contact details http://hsd.qmul.ac.uk/
Further resources and guidance for GM risk assessments:
1. 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).
2. The Genetically Modified Organisms (Contained Use) Regulations 2014
http://www.legislation.gov.uk/uksi/2014/1663/pdfs/uksi_20141663_en.pdf
3. The Scientific Advisory Committee on Genetic Modification (SACGM) Compendium of
Guidance http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/
4. QMUL GM Health and Safety Standard, Guidance and Arrangements
http://hsd.qmul.ac.uk/Policy%20-%20Guidance/index.html
5. Additional HSE / SACGM GMO documents and resources
http://www.hse.gov.uk/biosafety/gmo/information.htm
6. HSE / ACDP biological agents documents and resources
http://www.hse.gov.uk/biosafety/information.htm including categorisation of biological
agents please see: Advisory Committee on Dangerous Pathogens (ACDP).
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