Appendix 12
WORK INVOLVING GENETICALLY MODIFIED ORGANISMS
- RISK ASSESSMENT
This risk assessment form incorporates a biological agents risk assessment, so you do not have to
complete a separate Biological Agents Risk Assessment Form 10 (iii).
IF WORK ALSO INVOLVES HAZARDOUS CHEMICAL, E.G. DISINFECTANTS, A HAZARDOUS CHEMICALS
RISK ASSESSMENT section 11 MUST ALSO BE COMPLETED.
The purpose of this form is to provide the required notification of an intention to work with genetically
modified organisms and to complete an assessment of the risks associated with this work. This
assessment must include risks arising from both the modified and the un-modified biological agents to
be used in the work. It must also include an assessment of the risk to the environment as well as the
risk to human health.
A biological agent means “any micro-organism, including those which have been genetically
modified, a cell culture and a human endoparasite, which may be able to provoke any infection, allergy
toxicity or other risk to human health”. This includes bacteria, viruses, fungi and parasites. The
possible transmission of a biological agent through the usage of human and/or animal material and
incidental exposure e.g. work with soil, stagnant water, should be taken into account.
A genetically modified organism (GMO) is any organism (cellular or non-cellular) including bacteria,
viruses, fungi, plant and animal cells in which the genetic material has been altered in a way that does
not occur naturally by mating and/or natural recombination. Three examples (amongst others) of
techniques covered by this definition are:
 Recombinant DNA techniques using viral or bacterial vectors
 The direct introduction of DNA into an organism, e.g. by micro-injection
 Cell fusion or hybridisation
The submission of a risk assessment Form 10 (iv) for ‘Work involving genetically modified organism’
to the Research Ethics Committee is for consideration of the ethical aspects of the work involved.
Researchers should ensure that they formally submit work to a competent government authority in
compliance with current regulations (see below)
Submission to a Competent Authority
Researchers should note that they are obliged to register all operations with GMO’s with the relevant
authority.
The commencement of a GMO contained use operation (bacteria, plants, or animals) prior to the 1 st
January 1995 constitutes an existing use and a notification of existing use must be submitted to the
competent authority in accordance with Article 14 of the GMO Regulations, S.I. No. 345 of 1994.
Where the contained use commenced on January 1 st 1995 or anytime thereafter, a notification of first
time use must be submitted in accordance with Article 16 of the GMO Regulations, 1994.
Researchers should also note that Genetically Modified Micro-organisms (GMM) are classified as
Group I GMM or Group II GMM in accordance with GMO Regulations S.I. No. 348 of 1996. The
type of operation must be classified as Type A (Research & development) or Type (B) (Commercial) –
more precise definitions are provided under Article 3 of the GMO Regulations 1994.
Information Sources (as of December 2000)
Table 1 EU legislation
Directive/ Regulation
Purpose
Competent Authority
Aspects regulated
Directive 90/219/EEC
Regulates the contained
use of GMM s
EPA
Contained use of
Genetically Modified
Micro-organisms
(GMM's), also GM
animals & GM
plants.
Directive 90/220/EEC
Directive
Regulates the
deliberate release of
GMO's into the
environment for:
i. R&D purposes-Field
Trials
ii. Placing GMO
products on the market
EPA
Department of
Environment & Local
Government are
responsible for certain
functions, e.g.
decisions to place
GMO's on the market
under Article 21 of this
Directive.
Environmental
assessment for the
cultivation and
importation of GMO's
in the EU;
Animal feed aspects feeding of ‘live’
GMO's to animals;
Human health aspects
(including toxicity
and allergenicity),
related to the
cultivation of GM
crops in the EU.
Directive 90/679/EEC
Regulates biological
agents in the workplace
Health and Safety
Authority (HSA)
Workplace contact
Directive 94/55/EC
Regulates the
transportation of
certain GMO's
Department of
Enterprise Trade &
Employment
Transportation
Regulation 258/97/EC
Regulates Novel Foods
& Novel Food
Ingredients- including
GMO's
Department of Health
& Children
Foods and food
ingredients
containing or
consisting of GMO's;
Foods and food
ingredients produced
from, but not
containing GMO's,
for example, oil from
GM soybeans.
Regulation 1139/98/EC
Regulates the labeling
of certain foodstuffs
produced from GMO's
Department of Health
& Children
Labelling of foods
derived from GM
soybean and GM
maize (Ciba maize).
2309/93/EEC
Regulates GMO's for
medicinal and
veterinary use
Irish Medicines Board
(IMB)
Directive 91/414/EEC
Regulates the use of
plant protection
Pesticide Control
Service of the
Regulates medicinal
& veterinary products
including those
products which
contain or consist of
GMO's.
Regulates the use of
herbicides,
products
Department of
Agriculture & Food
insecticides &
fungicides etc. on
crops including GM
crops.
Table 2 EU Legislation in preparation
Directive
Seed for cultivation
Purpose
The proposed Directive
will amend current
Directives relating to
seed
Competent Authority
Department of
Agriculture & Food
will be responsible
Aspects regulated
Regulates GM seed to
be placed on catalogues
for use in agriculture.
Animal feed
The proposed Directive
will amend current
Directives relating to
animal feed
Department of
Agriculture & Food
will be responsible
Regulates animal
feeding stuffs
containing or
consisting of GMO's
and feed derived from
GMO's.
also contact:
Environmental Protection Agency: http://www.epa.ie/
Department of the Environment & Local Government http://www.environ.ie/
Department of Health & Children - http://www.doh.ie
Department of Agriculture and Food- http://www.irlgov.ie
Pesticide Control Service-DAF- http://www.irlgov.ie/daff/
Department of Enterprise, Trade and Employment- http://www.entemp.ie
Irish Medicines Board http://www.imb.ie
Health and Safety Authority http://www.hsa.ie
Food Safety Authority of Ireland http://www.fsai.ie/
The Department of Arts, Culture, Gaeltacht and the Islands - http://www.irlgov.ie/ealga/
EU Commission Sites: http://europa.eu.int/comm/dg11/abc.htm
http://europa.eu.int/comm/dg24/
Risk Assessment
The purpose of a risk assessment is to identify possible causes of harm and the measures needed to
avoid these – before an accident occurs.
A hazard is anything with the potential to cause harm. The risk is the likelihood that harm will be
incurred and the severity of the harm caused. A high risk is one that is very likely to occur and/or has
serious consequences (death, serious injury/illness, significant harm to the environment). A low risk is
extremely unlikely and/or would result in trivial or no injury/illness/harm to the environment. A
medium risk is in between these two.
By carrying out a risk assessment, you can direct attention and resources where they are most needed to
prevent harm.
There are five steps to carry out in a risk assessment:
1. Identify the hazards check suppliers’ information, journals and the list of biological agents
classified by the Health and Safety Authority (www.hsa.ie/ see legislation above). Consider how
the agents cause illness e.g. inhaled spore or dust, skin contact, via cuts or mucus membranes.
Think about hazards at all stages including preparation, storage and disposal. Contact your School
Safety Officer and/or Head of School for documentation on Health and Safety policies. Information
on general health and safety issues may be obtained from the Health and Safety Authority web page
www.hsa.ie/ and www.hsa.ie/osh/regs.htm. These sites contain information on the Safety, Health
and Welfare at Work Act, 1989 including the Safety. Health and Welfare at Work (Biological
Agents) Regulations, 1994.
2. Identify who might be harmed and how - think about the people directly involved and also others
who may be affected. Look at how the work is actually done, rather than how it should be done or
how you think it is done. Inexperienced people or those with health problems or who are pregnant
may be at greater risk and need extra protection.
3. Evaluate the risks and consider how the risk of harm can be reduced - consider whether
existing measures give adequate protection and what more should be done to reduce risks. Is it
possible to get rid of the risk altogether by using a different agent or process?
4. Record your findings - on the risk assessment form overleaf. Include instructions for safe disposal
of waste and emergency procedures, including decontamination and first aid. A copy of your
assessment form should be kept near to where the work is being done, and everyone involved
should be familiar with the contents. Ideally, the assessment should be included in practical scripts,
laboratory and research protocols. The assessment should form the basis of safe working practices
and local rules. Don’t just fill in the form and forget it - make sure everyone in your team or class
knows about the risks and how to avoid them.
5. Review and revise your assessment where necessary - you should do this when there are
significant changes in materials, equipment, work methods, location or people involved.
Assessments should also be reviewed if there are accidents, near misses or complaints associated
with the work.
SECTION 13
WORK INVOLVING GENETICALLY MODIFIED ORGANISMS
- RISK ASSESSMENT
13.1 Researcher Details
Name (use block capitals):
Title:
Faculty/ School/Department:
13.2 Location of Work
[Please type here]
13.3 Title and Description of Work
Outline procedures to be used, giving source references where appropriate. Details of host and donor
organisms, vectors used and insert genes etc should be outlined. Continue on separate sheet if
necessary.
You may need to complete separate assessment forms e.g. if different vectors or hosts are used.
13.4 Proposed time-scale for completion of research
Time-scale:
13.5 Personnel involved
List all names, relevant qualifications and experience, including training in the techniques to be used.
13.6 Compliance with GMO Regulations
(iv) 10.6.1 Has the relevant Competent Authority been notified of the work with the GMO? Yes/No
delete yes or no as necessary
If Yes
(a) Name the Competent Authority:
(b) Has approval for the work to commence been received from the Competent Authority? Yes/No
delete yes or no as necessary
(c) If approval has not yet been received when is the anticipated approval date? Give Date:
(d) When is the anticipated start date of the work with the GMO? Give Date:
Documentation indicating approval for commencement of work should be supplied with this form.
If No
(a) Name the Competent Authority that submission is being made to:
(b) When is the submission to be made? Give Date:
(c) What is the anticipated approval date? Give Date:
(d) When is the anticipated start date of the work with the GMO? Give Date:
Documentation indicating approval for commencement of work should be supplied to the Ethics
Research Committee when it becomes available.
13.7 Classification of Genetically Modified Organism
State whether Group I or II:
Group:
13.8 Classification of Operation Type
State whether Operation Type A or B
Operation Type:
13.9. Laboratory containment level required
Please refer for assistance to the Health, Safety and Welfare at Work (Biological Agents) Regulations,
1994 (www.hsa.ie/ see legislation above)
GMO’s must be contained safely for transport within laboratories. If movement of GMO’s between
facilities is likely include an outline of containment procedures for transfer.
Specify level (1-4):
13.10 Hazards
13.10.1 Hazards to human health
RISK
Of biological agents, e.g.: pathogenic, infective, blood borne infection;
skin sensitization; sensitization by inhalation; toxic by ingestion or
inhalation and/or routes of exposure e.g. inhalation; skin contact;
accidental inoculation
(High, medium, Low or
negligible)
1.
2.
3.
4.
5.
6.
13.10.2 Environmental Hazards For example to plants; animals or
other organisms
RISK
(High, medium, low or
negligible)
1 Capacity to survive, establish, disseminate and/or displace other
organisms/plants/animals
2 Pathogenicity to plants and/or animals
3 Potential for transfer of genetic material between GMO and other
organisms
4 Products of gene expression that could be toxic to other
organisms/plants/animals
5 Phenotypic and genetic stability
6 Potential to cause other harm to target or non-target
organisms/plants/animals (specify what sort of harm)
13.10.3 Equipment hazards
RISK
For example: electrical; ultra violet; noise; high temperatures or pressures
(High, medium, Low or
negligible)
1.
2.
3.
4.
5.
6.
13.11 Location
Laboratory(s) and building(s) where work will be carried out
10.12 Who else is at risk?
For example: staff/students nearby; technicians, cleaning & maintenance staff; visitors, contractors
This should include the potential for interaction with other work being carried out in the laboratory
Category at risk
RISK
(High, medium, low or negligible)
1.
2
3
4
5
6
13.13 Arrangements for disinfection and disposal methods of GMO’s, vectors, biologically
contaminated materials etc
For example: autoclave; chemically disinfect (specify); incinerate; sharps bin etc.
1.
2.
3.
4.
5.
6.
13.14 Prevention/control measures provided
For example; biological containment cabinets (specify type); protective clothing (specify); respiratory
protection; restricted access to work areas; information; supervision.
1.
2.
3.
4.
5.
6.
13.15 Further control measures to be considered
ACTION
For example: use of more extensively disabled host; enclose process etc.
(DATE)
1.
2.
3.
4.
5.
6.
13.16 Monitoring/surveillance measures
(a) Environmental monitoring procedures in place to detect contamination of
workers/workplace/environment/water effluents etc and the frequency with which they will be
carried out
Please give outline details and supporting documentation if necessary.
1.
2.
3.
4.
5.
6.
(b) Will health surveillance be required?
Yes/No
(delete yes or no as necessary)
If yes please give details of what is required and how this will be implemented. Please supply
supporting documentation if required.
1.
2.
3.
4.
5.
6.
(c) Will vaccination be required?
Yes/No
(delete yes or no as necessary)
If yes give details of what is required and how this is to be implemented.
13.17 Will there be any specific training requirements to ensure that the work is carried out
safely?
Yes/No
(delete yes or no as necessary)
If yes please give details of what is required and how this will be provided. Please supply supporting
documentation if required.
1.
2.
3.
4.
5.
6.
13.18 Emergency procedures in case of spillage (include protective equipment needed,
decontamination procedures, notification requirements etc)
1.
2.
3.
4.
5.
6.
13.19 First aid provisions (including training and equipment )
1.
2.
3.
4.
5.
6.
13.20 Sources of information used for this assessment
1.
2.
3.
4.
5.
6.
13.21 Person(s) completing this assessment :
Signature: _________________________
Signature: _________________________
Print Name: ________________________
Print Name: ________________________
Title: __________________________
Title: __________________________
Date: __________________________
Date: __________________________
13.22 Approved by Safety Officer (or Head of School)
Signature: ___________________________________ Title: __________________________
Print Name: ________________________
Date: ________________________________
13.23 Approved by Head of School
Signature: ___________________________________ Title: __________________________
Print Name: ________________________
Date: ________________________________