SCBS risk assessment form for project reference no: ................................ (Insert ref. number as allocated by
SCBS)
Sub Committee for Biological Safety
Human and Environmental Risk Assessment
for activities involving the
Contained Use of genetically modified organisms
Before completing this form please read the notes for guidance below. The Biological Safety Officer
[ext. 8887, or m.iosson@rdg.ac.uk] may be consulted for advice and further information.
Notes for Guidance, and where to obtain further help.
A copy of this form must accompany each new GM project proposal (form GM1): the aim is to assist you when
writing the Lay Summary for assessment by SCBS. It should also be used in the annual review of each GM
project.
See Safety Guide 15 (3rd edition) for general advice of GM procedures at The University, including activity
classification. You should also consult the ACGM Compendium of Guidance, available from the HSE website,
http://www.hse.gov.uk/biosafety/gmo/acgm/acgmcomp/
Possible hazards
For Part A, question 1: include any toxic, allergenic or other pathogenic effects that could be caused by the GMM
on humans and/ or other organisms. Take into account the levels of expression expected in the GMM, and the
source of the gene/ sequence being expressed. For “antisense” RNA transcripts, identify function of gene(s)
interfered with and indicate possible effects on the resultant GMO. Take into account any possible need for an
inducer to initiate protein production. Do not forget factors such as antibiotic resistance markers in plasmid
vectors! For genetically modified viruses or viral vectors, include possibility of recombination with unmodified or
related viruses infecting the same target cell. Other hazards include colonisation of the human or other organisms
by the GMM; ability to survive in the environment; competition with organisms in established ecosystems; ability of
the GMM to transfer genes to other organisms, etc.
For Part B, question 8: Possible hazards are similar to those of GMMs, with the exception of infection. The
assessment must include possible hazards to humans (e.g., toxic or allergenic effects) as well as hazards to the
environment. For GM plants, particular attention should be paid to dissemination of seeds, pollen, etc., and to the
products of gene expression, especially if they are toxic or potentially allergenic. Phenotypic and/ or genotypic
stability may also be important, especially if loss or movement of the inserted genetic material could have other
consequences, such as altering the expression of other genes within the plant. If the inserted genetic material
includes antibiotic resistance or herbicide tolerance genes as markers, any environmental effects of marker transfer
to other organisms must be included.
When assessing likelihood (Part A, Q2;) and Part B, Q9 take into account the properties of the GMO, the scale of
operations, and pay particular attention to any techniques that are likely to increase exposure of individuals to
GMMs (e.g., operations creating aerosols.) The likelihood of these hazards being realised will depend on the nature
of the receiving environment.
In order to interpret the term “posing no greater risks to humans than the non-modified parent" (formerly “as safe in
containment as the non-modified parent, “ASIC”), applicants need only consider the effects of the modifications
on the properties [including “behaviour”, if appropriate] of the organism that has been modified. Whether the
recipient or parental organism itself is or is not “safe” in containment is irrelevant to the classification, but it must not
be forgotten when making any arrangements for supervision of the work.
Risk Assessment matrix: The following table should be used when assessing the magnitude of the risk from the
likelihood and the consequences of a hazard being realised. (Risk = likelihood x consequence). The term "nonzero risk" is used for those risks over and above the magnitude of "effectively zero".
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SCBS risk assessment form for project reference no: ................................ (Insert ref. number as allocated by
SCBS)
Likelihood of hazard being realised
Medium
Low
Negligible
Consequence of hazard being realised
High
Severe (e.g., danger of death or major
effects on human health or ecosystems)
Medium (e.g., major effects on a few
individuals)
Low (Only minor effects)
High
High
Medium
Effectively zero
High
Medium
Medium/ Low
Effectively zero
Medium/ Low
Low
Low
Effectively zero
Negligible (Possible effects hard to
detect)
Effectively zero
Effectively zero
Effectively zero
Effectively zero
Unless the risk is "Effectively zero" under conditions equating to Containment level 1, additional containment
measures will be required to reduce the risk to "Effectively zero". The nature of the additional containment
measures determines the Risk Class for the GMM (see below.) Thus, for example, a GMM which is derived from an
animal pathogen normally requiring Containment level 2 should be assessed as having a low to medium
consequence if it were to escape from containment and infect its normal host species. This would apply, unless
there is definitive evidence that the GMM is non-pathogenic, and unlikely to cause any other effects in the
target species (i.e., consequence is "negligible"). In the absence of such evidence, it must be assumed that the
GMM may still be pathogenic, and have low - medium consequence if it were to escape.
The likelihood of escape would depend on the containment level applied. If the consequence is "negligible",
containment level 1 would suffice, but otherwise, the risk can only be reduced to "effectively zero" by applying
additional containment measures. The nature of the additional measures helps to determine the risk class (see
below.)
Assignment of Risk Class (for GMMs).
The risk class for GMMs is equal to the level of the containment required to control the risks of the activity.
For example, consider the situation when a microbiological safety cabinet (or other equipment) is required to control
infectious aerosols, but it is not necessary to have the laboratory sealable for fumigation. This is a characteristic of
Containment level 2, hence the activity would be classified as Class 2. This is irrespective of whether the GMM is
infectious for humans, or it could have a moderate environmental impact if it were to escape from containment.
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SCBS risk assessment form for project reference no: ................................ (Insert ref. number as allocated by
SCBS)
Risk assessment and classification
Where this form is used for the Annual Review of the risk assessment,
highlight any changes made since the last risk assessment form for this
project was submitted.
Please complete
Part A for GMMs, and / or
Part B for GMOs that are not microorganisms.
You will need to complete both parts of this section if your project
involves both GMMs and higher organisms.
Please delete part A if not applicable
Part A: Activities with genetically modified microorganisms
Use the information in the project proposal form GM1 to answer the questions posed
below. You must justify any statements made, e.g., by references to the scientific literature
where necessary.
Please ensure that you include consideration of those aspects of the proposed work that
will carry the greatest risk.
1.
Identify all
potentially
hazardous
properties of each
GMM. Do not forget
hazardous
properties of the
parental organism.
Consider ALL
properties of the host,
vector, insert, and of
the final GMM. Use one
entry for each type of
GMM.
Separately list hazards
to human health and
safety, and hazards to
the environment.
A: Hazards to Human health & safety:
B: Hazards to the environment (consider animals, plants,
microorganisms, etc.)
For humans, identify
those persons who
could be exposed to
the hazard.
See Note 2
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SCBS risk assessment form for project reference no: ................................ (Insert ref. number as allocated by
SCBS)
Likelihood of hazards
associated with
GMM being
realised.
A: Hazards to human health & safety
(Take into account any
disabling mutations in
the GMM; the scale and
type of operations, plus
the containment level
to be used. Also take
into account any
possible routes of
transmission of the
GMM to potential
hosts.)
Use the terms "High",
"Medium", "Low" or
"Negligible" and give
B: Hazards to the environment
details of scale and
type of operations to
be done with each
GMM.
Note also that the
likelihood of
environmental hazards
being realised will
depend on the nature
of the “receiving
environment”, i.e., the
occurrence of
potentially susceptible
hosts in the
neighbourhood of the
containment facility
Expand box as required
See Note 3
Consequence of
hazards being
realised. (For the
purpose of this
assessment,
assume that there
are no barriers
between the GMM
and the
environment, and
that it can colonise
or enter the
environment.)
Use the terms "Severe",
"Medium", "Low" or
"Negligible" and give
details of the expected
consequences
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A: Human health & safety
B: Environmental safety
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SCBS risk assessment form for project reference no: ................................ (Insert ref. number as allocated by
SCBS)
Estimation of risk
magnitude
A: Risks to Human health & safety
(Magnitude of Risk
= "likelihood" x
"consequence" of
causing harm.)
Use one line for
each GMM.
B:Risks to the Environment
See Note 4, "Risk
matrix".
For each GMM where
the risk is not
"effectively zero" at
Containment level
1, please identify
the nature of all the
"non-zero" risks.
See Notes 5 and 6.
Identify all additional
measures
necessary to
control the above
risks.
State class of activity
(equivalent to that
level of
containment with
characteristic
measures identified
as necessary in Q6)
See Note 6
Class 1/Class 2/Class 3 (please delete as applicable)
Note: Activities in Class 2 and/or Class 3 must be notified to HSE
[Please delete part B if not applicable]
Part B: Projects involving the use of GMOs that are not
microorganisms.
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SCBS risk assessment form for project reference no: ................................ (Insert ref. number as allocated by
SCBS)
Identify all potentially
hazardous
properties of the
GMO(s)
Take into account any
toxic or allergenic effects
of expression in the
GMO; ability to transfer
genes to, or interfere with
other organisms in
established ecosystems;
acting as a novel
reservoir for a pathogen,
etc.
See Note 2 on p. 1.
Estimate the likelihood
that these hazards
could be realised.
A: Hazards to human health & safety
B: Hazards to the environment
A: Hazards to human health & safety
Take into account the
containment measures to
be applied.
Use the terms "High",
"Medium", "Low" or
"Negligible" and give
details of scale and type
of operations to be done
with each GMO.
Estimate the
consequence of
these hazards
being realised.
B: Hazards to the environment
A: Human health & safety
(For the purpose of this
assessment, assume
that the GMO is not
contained.)
B: Environment
Use the terms "Severe",
"Medium", "Low" or
"Negligible" and give
details of the expected
consequences
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SCBS risk assessment form for project reference no: ................................ (Insert ref. number as allocated by
SCBS)
Estimation of risk
magnitude
A: Risks to human health & safety
(Risk = "likelihood" x
"consequence" of
causing harm.)
Use one line for each
GMO.
See Note 4, "Risk matrix"
B: Risks to the environment
For each GMO where
the risk is not
"effectively zero",
identify the nature
of these "non-zero"
risks.
A: Risks to human health & safety
B: Risks to the environment
Identify all measures
necessary to
control the above
risks.
A: Risks to human health & safety
B: Risks to the environment
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SCBS risk assessment form for project reference no: ................................ (Insert ref. number as allocated by
SCBS)
Based on the
information in Q12,
does the GMO pose
any greater risks to
human health and
safety than the nonmodified parent?
See Note 3
Yes/ No
(please delete as necessary)
(Note: the answer to this question is independent of any additional control measures
identified above.) If "Yes" the project must be notified to HSE.
Summary Statements
The main sources of information for "lay" members of the Committee are the "Statement on overall risks" and
the Lay Summary. They will be copied and submitted to the Committee for formal approval. Sufficient detail,
in non-technical terms, should therefore be given to allow them to understand the aims of the project, and to
confirm the low–risk nature of the project.
Statement on the overall risks associated with this project
Use the information
provided in Parts A and/
or B to draft this
statement. You should
identify the most
hazardous elements of
the project, and any
procedures necessary to
control the associated
risks. Extend the section
as necessary.
A: Risks to human health & safety
B: Risks to the environment
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SCBS risk assessment form for project reference no: ................................ (Insert ref. number as allocated by
SCBS)
Lay summary of the project
Outline the aims and
expected results of
the project. Where
possible, avoid the
use of acronyms and
abbreviations, and
explain or spell out
any used. ("DNA" and
"RNA" need not be
spelt out.)
Clearly identify the
risk class for the
project.
Describe the
measures to be put in
place to control the
identified risks.
Particular attention
should be paid to
those measures
taken to
decontaminate waste
and / or equipment
and/or to prevent
dissemination of
GMOs from the
laboratory. Note that
the Regulations now
require that waste
containing GMMs
must be inactivated
by validated means.
[Expand box as
required.]
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SCBS risk assessment form for project reference no: ................................ (Insert ref. number as allocated by
SCBS)
Declaration and signature
Please sign and date the declaration below before returning this form to :
The Biological Safety Officer
Safety Services
Physics.
If this form is used to
assess the risks of a new
project proposal, please
contact the BSO for the
allocation of a project
reference number before
submitting your
proposals.
I declare that the information given in this form summarises my
intentions for of GM project number …………..,
(Insert ref. number as allocated by SCBS)
and represents my assessment of the risks associated with that
project.
Name………………………………………….(Please type)
Area/ School……………………………………….
Signed………………………………………
Dated
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/
/200… (insert date)
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